TITLE VI--TRANSPARENCY AND PROGRAM INTEGRITY

         Subtitle A--Physician Ownership and Other Transparency

SEC. 6001. LIMITATION ON MEDICARE EXCEPTION TO THE PROHIBITION ON 
            CERTAIN PHYSICIAN REFERRALS FOR HOSPITALS.

    (a) In General.--Section 1877 of the Social Security Act (42 U.S.C. 
1395nn) is amended--
            (1) in subsection (d)(2)--
                    (A) in subparagraph (A), by striking ``and'' at the 
                end;
                    (B) in subparagraph (B), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by adding at the end the following new 
                subparagraph:
                    ``(C) in the case where the entity is a hospital, 
                the hospital meets the requirements of paragraph 
                (3)(D).'';

[[Page 124 STAT. 685]]

            (2) in subsection (d)(3)--
                    (A) in subparagraph (B), by striking ``and'' at the 
                end;
                    (B) in subparagraph (C), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by adding at the end the following new 
                subparagraph:
                    ``(D) <<NOTE: Deadline.>> the hospital meets the 
                requirements described in subsection (i)(1) not later 
                than 18 months after the date of the enactment of this 
                subparagraph.''; and
            (3) by adding at the end the following new subsection:

    ``(i) Requirements for Hospitals To Qualify for Rural Provider and 
Hospital Exception to Ownership or Investment Prohibition.--
            ``(1) Requirements described.--For purposes of subsection 
        (d)(3)(D), the requirements described in this paragraph for a 
        hospital are as follows:
                    ``(A) Provider agreement.--The hospital had--
                          ``(i) physician ownership or investment on 
                      February 1, 2010; and
                          ``(ii) a provider agreement under section 1866 
                      in effect on such date.
                    ``(B) Limitation on expansion of facility 
                capacity.--Except as provided in paragraph (3), the 
                number of operating rooms, procedure rooms, and beds for 
                which the hospital is licensed at any time on or after 
                the date of the enactment of this subsection is no 
                greater than the number of operating rooms, procedure 
                rooms, and beds for which the hospital is licensed as of 
                such date.
                    ``(C) Preventing conflicts of interest.--
                          ``(i) <<NOTE: Reports.>> The hospital submits 
                      to the Secretary an annual report containing a 
                      detailed description of--
                                    ``(I) the identity of each physician 
                                owner or investor and any other owners 
                                or investors of the hospital; and
                                    ``(II) the nature and extent of all 
                                ownership and investment interests in 
                                the hospital.
                          ``(ii) The hospital has procedures in place to 
                      require that any referring physician owner or 
                      investor discloses to the patient being referred, 
                      by a time that permits the patient to make a 
                      meaningful decision regarding the receipt of care, 
                      as determined by the Secretary--
                                    ``(I) the ownership or investment 
                                interest, as applicable, of such 
                                referring physician in the hospital; and
                                    ``(II) if applicable, any such 
                                ownership or investment interest of the 
                                treating physician.
                          ``(iii) The hospital does not condition any 
                      physician ownership or investment interests either 
                      directly or indirectly on the physician owner or 
                      investor making or influencing referrals to the 
                      hospital or otherwise generating business for the 
                      hospital.
                          ``(iv) The hospital discloses the fact that 
                      the hospital is partially owned or invested in by 
                      physicians--
                                    ``(I) on any public website for the 
                                hospital; and
                                    ``(II) in any public advertising for 
                                the hospital.
                    ``(D) Ensuring bona fide investment.--

[[Page 124 STAT. 686]]

                          ``(i) The percentage of the total value of the 
                      ownership or investment interests held in the 
                      hospital, or in an entity whose assets include the 
                      hospital, by physician owners or investors in the 
                      aggregate does not exceed such percentage as of 
                      the date of enactment of this subsection.
                          ``(ii) Any ownership or investment interests 
                      that the hospital offers to a physician owner or 
                      investor are not offered on more favorable terms 
                      than the terms offered to a person who is not a 
                      physician owner or investor.
                          ``(iii) The hospital (or any owner or investor 
                      in the hospital) does not directly or indirectly 
                      provide loans or financing for any investment in 
                      the hospital by a physician owner or investor.
                          ``(iv) The hospital (or any owner or investor 
                      in the hospital) does not directly or indirectly 
                      guarantee a loan, make a payment toward a loan, or 
                      otherwise subsidize a loan, for any individual 
                      physician owner or investor or group of physician 
                      owners or investors that is related to acquiring 
                      any ownership or investment interest in the 
                      hospital.
                          ``(v) Ownership or investment returns are 
                      distributed to each owner or investor in the 
                      hospital in an amount that is directly 
                      proportional to the ownership or investment 
                      interest of such owner or investor in the 
                      hospital.
                          ``(vi) Physician owners and investors do not 
                      receive, directly or indirectly, any guaranteed 
                      receipt of or right to purchase other business 
                      interests related to the hospital, including the 
                      purchase or lease of any property under the 
                      control of other owners or investors in the 
                      hospital or located near the premises of the 
                      hospital.
                          ``(vii) The hospital does not offer a 
                      physician owner or investor the opportunity to 
                      purchase or lease any property under the control 
                      of the hospital or any other owner or investor in 
                      the hospital on more favorable terms than the 
                      terms offered to an individual who is not a 
                      physician owner or investor.
                    ``(E) Patient safety.--
                          ``(i) Insofar as the hospital admits a patient 
                      and does not have any physician available on the 
                      premises to provide services during all hours in 
                      which the hospital is providing services to such 
                      patient, before admitting the patient--
                                    ``(I) the hospital discloses such 
                                fact to a patient; and
                                    ``(II) following such disclosure, 
                                the hospital receives from the patient a 
                                signed acknowledgment that the patient 
                                understands such fact.
                          ``(ii) The hospital has the capacity to--
                                    ``(I) provide assessment and initial 
                                treatment for patients; and
                                    ``(II) refer and transfer patients 
                                to hospitals with the capability to 
                                treat the needs of the patient involved.

[[Page 124 STAT. 687]]

                    ``(F) Limitation on application to certain converted 
                facilities.--The hospital was not converted from an 
                ambulatory surgical center to a hospital on or after the 
                date of enactment of this subsection.
            ``(2) <<NOTE: Deadline. Web posting.>> Publication of 
        information reported.--The Secretary shall publish, and update 
        on an annual basis, the information submitted by hospitals under 
        paragraph (1)(C)(i) on the public Internet website of the 
        Centers for Medicare & Medicaid Services.
            ``(3) Exception to prohibition on expansion of facility 
        capacity.--
                    ``(A) Process.--
                          ``(i) Establishment.--The Secretary shall 
                      establish and implement a process under which an 
                      applicable hospital (as defined in subparagraph 
                      (E)) may apply for an exception from the 
                      requirement under paragraph (1)(B).
                          ``(ii) Opportunity for community input.--The 
                      process under clause (i) shall provide individuals 
                      and entities in the community in which the 
                      applicable hospital applying for an exception is 
                      located with the opportunity to provide input with 
                      respect to the application.
                          ``(iii) Timing for implementation.--The 
                      Secretary shall implement the process under clause 
                      (i) on August 1, 2011.
                          ``(iv) <<NOTE: Deadline.>> Regulations.--Not 
                      later than July 1, 2011, the Secretary shall 
                      promulgate regulations to carry out the process 
                      under clause (i).
                    ``(B) Frequency.--The process described in 
                subparagraph (A) shall permit an applicable hospital to 
                apply for an exception up to once every 2 years.
                    ``(C) Permitted increase.--
                          ``(i) In general.--Subject to clause (ii) and 
                      subparagraph (D), an applicable hospital granted 
                      an exception under the process described in 
                      subparagraph (A) may increase the number of 
                      operating rooms, procedure rooms, and beds for 
                      which the applicable hospital is licensed above 
                      the baseline number of operating rooms, procedure 
                      rooms, and beds of the applicable hospital (or, if 
                      the applicable hospital has been granted a 
                      previous exception under this paragraph, above the 
                      number of operating rooms, procedure rooms, and 
                      beds for which the hospital is licensed after the 
                      application of the most recent increase under such 
                      an exception).
                          ``(ii) 100 percent increase limitation.--The 
                      Secretary shall not permit an increase in the 
                      number of operating rooms, procedure rooms, and 
                      beds for which an applicable hospital is licensed 
                      under clause (i) to the extent such increase would 
                      result in the number of operating rooms, procedure 
                      rooms, and beds for which the applicable hospital 
                      is licensed exceeding 200 percent of the baseline 
                      number of operating rooms, procedure rooms, and 
                      beds of the applicable hospital.
                          ``(iii) Baseline number of operating rooms, 
                      procedure rooms, and beds.--In this paragraph, the 
                      term `baseline number of operating rooms, 
                      procedure

[[Page 124 STAT. 688]]

                      rooms, and beds' means the number of operating 
                      rooms, procedure rooms, and beds for which the 
                      applicable hospital is licensed as of the date of 
                      enactment of this subsection.
                    ``(D) Increase limited to facilities on the main 
                campus of the hospital.--Any increase in the number of 
                operating rooms, procedure rooms, and beds for which an 
                applicable hospital is licensed pursuant to this 
                paragraph may only occur in facilities on the main 
                campus of the applicable hospital.
                    ``(E) Applicable hospital.--In this paragraph, the 
                term `applicable hospital' means a hospital--
                          ``(i) that is located in a county in which the 
                      percentage increase in the population during the 
                      most recent 5-year period (as of the date of the 
                      application under subparagraph (A)) is at least 
                      150 percent of the percentage increase in the 
                      population growth of the State in which the 
                      hospital is located during that period, as 
                      estimated by Bureau of the Census;
                          ``(ii) whose annual percent of total inpatient 
                      admissions that represent inpatient admissions 
                      under the program under title XIX is equal to or 
                      greater than the average percent with respect to 
                      such admissions for all hospitals located in the 
                      county in which the hospital is located;
                          ``(iii) that does not discriminate against 
                      beneficiaries of Federal health care programs and 
                      does not permit physicians practicing at the 
                      hospital to discriminate against such 
                      beneficiaries;
                          ``(iv) that is located in a State in which the 
                      average bed capacity in the State is less than the 
                      national average bed capacity; and
                          ``(v) that has an average bed occupancy rate 
                      that is greater than the average bed occupancy 
                      rate in the State in which the hospital is 
                      located.
                    ``(F) Procedure rooms.--In this subsection, the term 
                `procedure rooms' includes rooms in which 
                catheterizations, angiographies, angiograms, and 
                endoscopies are performed, except such term shall not 
                include emergency rooms or departments (exclusive of 
                rooms in which catheterizations, angiographies, 
                angiograms, and endoscopies are performed).
                    ``(G) <<NOTE: Deadline. Federal Register, 
                publication.>> Publication of final decisions.--Not 
                later than 60 days after receiving a complete 
                application under this paragraph, the Secretary shall 
                publish in the Federal Register the final decision with 
                respect to such application.
                    ``(H) Limitation on review.--There shall be no 
                administrative or judicial review under section 1869, 
                section 1878, or otherwise of the process under this 
                paragraph (including the establishment of such process).
            ``(4) Collection of ownership and investment information.--
        For purposes of subparagraphs (A)(i) and (D)(i) of paragraph 
        (1), the Secretary shall collect physician ownership and 
        investment information for each hospital.
            ``(5) Physician owner or investor defined.--For purposes of 
        this subsection, the term `physician owner or investor' means a 
        physician (or an immediate family member of such

[[Page 124 STAT. 689]]

        physician) with a direct or an indirect ownership or investment 
        interest in the hospital.
            ``(6) Clarification.--Nothing in this subsection shall be 
        construed as preventing the Secretary from revoking a hospital's 
        provider agreement if not in compliance with regulations 
        implementing section 1866.''.

    (b) Enforcement.--
            (1) <<NOTE: Procedures. 42 USC 1395nn note.>> Ensuring 
        compliance.--The Secretary of Health and Human Services shall 
        establish policies and procedures to ensure compliance with the 
        requirements described in subsection (i)(1) of section 1877 of 
        the Social Security Act, as added by subsection (a)(3), 
        beginning on the date such requirements first apply. Such 
        policies and procedures may include unannounced site reviews of 
        hospitals.
            (2) <<NOTE: Deadline.>> Audits.--Beginning not later than 
        November 1, 2011, the Secretary of Health and Human Services 
        shall conduct audits to determine if hospitals violate the 
        requirements referred to in paragraph (1).

SEC. 6002. TRANSPARENCY REPORTS AND REPORTING OF PHYSICIAN OWNERSHIP OR 
            INVESTMENT INTERESTS.

    Part A of title XI of the Social Security Act (42 U.S.C. 1301 et 
seq.) is amended by inserting after section 1128F the following new 
section:

``SEC. 1128G. <<NOTE: Electronic format. 42 USC 1320a-7h.>> TRANSPARENCY 
            REPORTS AND REPORTING OF PHYSICIAN OWNERSHIP OR INVESTMENT 
            INTERESTS.

    ``(a) Transparency Reports.--
            ``(1) Payments or other transfers of value.--
                    ``(A) In general.--On March 31, 2013, and on the 
                90th day of each calendar year beginning thereafter, any 
                applicable manufacturer that provides a payment or other 
                transfer of value to a covered recipient (or to an 
                entity or individual at the request of or designated on 
                behalf of a covered recipient), shall submit to the 
                Secretary, in such electronic form as the Secretary 
                shall require, the following information with respect to 
                the preceding calendar year:
                          ``(i) The name of the covered recipient.
                          ``(ii) The business address of the covered 
                      recipient and, in the case of a covered recipient 
                      who is a physician, the specialty and National 
                      Provider Identifier of the covered recipient.
                          ``(iii) The amount of the payment or other 
                      transfer of value.
                          ``(iv) The dates on which the payment or other 
                      transfer of value was provided to the covered 
                      recipient.
                          ``(v) A description of the form of the payment 
                      or other transfer of value, indicated (as 
                      appropriate for all that apply) as--
                                    ``(I) cash or a cash equivalent;
                                    ``(II) in-kind items or services;
                                    ``(III) stock, a stock option, or 
                                any other ownership interest, dividend, 
                                profit, or other return on investment; 
                                or
                                    ``(IV) any other form of payment or 
                                other transfer of value (as defined by 
                                the Secretary).

[[Page 124 STAT. 690]]

                          ``(vi) A description of the nature of the 
                      payment or other transfer of value, indicated (as 
                      appropriate for all that apply) as--
                                    ``(I) consulting fees;
                                    ``(II) compensation for services 
                                other than consulting;
                                    ``(III) honoraria;
                                    ``(IV) gift;
                                    ``(V) entertainment;
                                    ``(VI) food;
                                    ``(VII) travel (including the 
                                specified destinations);
                                    ``(VIII) education;
                                    ``(IX) research;
                                    ``(X) charitable contribution;
                                    ``(XI) royalty or license;
                                    ``(XII) current or prospective 
                                ownership or investment interest;
                                    ``(XIII) direct compensation for 
                                serving as faculty or as a speaker for a 
                                medical education program;
                                    ``(XIV) grant; or
                                    ``(XV) any other nature of the 
                                payment or other transfer of value (as 
                                defined by the Secretary).
                          ``(vii) If the payment or other transfer of 
                      value is related to marketing, education, or 
                      research specific to a covered drug, device, 
                      biological, or medical supply, the name of that 
                      covered drug, device, biological, or medical 
                      supply.
                          ``(viii) Any other categories of information 
                      regarding the payment or other transfer of value 
                      the Secretary determines appropriate.
                    ``(B) Special rule for certain payments or other 
                transfers of value.--In the case where an applicable 
                manufacturer provides a payment or other transfer of 
                value to an entity or individual at the request of or 
                designated on behalf of a covered recipient, the 
                applicable manufacturer shall disclose that payment or 
                other transfer of value under the name of the covered 
                recipient.
            ``(2) Physician ownership.--In addition to the requirement 
        under paragraph (1)(A), on March 31, 2013, and on the 90th day 
        of each calendar year beginning thereafter, any applicable 
        manufacturer or applicable group purchasing organization shall 
        submit to the Secretary, in such electronic form as the 
        Secretary shall require, the following information regarding any 
        ownership or investment interest (other than an ownership or 
        investment interest in a publicly traded security and mutual 
        fund, as described in section 1877(c)) held by a physician (or 
        an immediate family member of such physician (as defined for 
        purposes of section 1877(a))) in the applicable manufacturer or 
        applicable group purchasing organization during the preceding 
        year:
                    ``(A) The dollar amount invested by each physician 
                holding such an ownership or investment interest.
                    ``(B) The value and terms of each such ownership or 
                investment interest.

[[Page 124 STAT. 691]]

                    ``(C) Any payment or other transfer of value 
                provided to a physician holding such an ownership or 
                investment interest (or to an entity or individual at 
                the request of or designated on behalf of a physician 
                holding such an ownership or investment interest), 
                including the information described in clauses (i) 
                through (viii) of paragraph (1)(A), except that in 
                applying such clauses, `physician' shall be substituted 
                for `covered recipient' each place it appears.
                    ``(D) Any other information regarding the ownership 
                or investment interest the Secretary determines 
                appropriate.

    ``(b) Penalties for Noncompliance.--
            ``(1) Failure to report.--
                    ``(A) In general.--Subject to subparagraph (B) 
                except as provided in paragraph (2), any applicable 
                manufacturer or applicable group purchasing organization 
                that fails to submit information required under 
                subsection (a) in a timely manner in accordance with 
                rules or regulations promulgated to carry out such 
                subsection, shall be subject to a civil money penalty of 
                not less than $1,000, but not more than $10,000, for 
                each payment or other transfer of value or ownership or 
                investment interest not reported as required under such 
                subsection. Such penalty shall be imposed and collected 
                in the same manner as civil money penalties under 
                subsection (a) of section 1128A are imposed and 
                collected under that section.
                    ``(B) Limitation.--The total amount of civil money 
                penalties imposed under subparagraph (A) with respect to 
                each annual submission of information under subsection 
                (a) by an applicable manufacturer or applicable group 
                purchasing organization shall not exceed $150,000.
            ``(2) Knowing failure to report.--
                    ``(A) In general.--Subject to subparagraph (B), any 
                applicable manufacturer or applicable group purchasing 
                organization that knowingly fails to submit information 
                required under subsection (a) in a timely manner in 
                accordance with rules or regulations promulgated to 
                carry out such subsection, shall be subject to a civil 
                money penalty of not less than $10,000, but not more 
                than $100,000, for each payment or other transfer of 
                value or ownership or investment interest not reported 
                as required under such subsection. Such penalty shall be 
                imposed and collected in the same manner as civil money 
                penalties under subsection (a) of section 1128A are 
                imposed and collected under that section.
                    ``(B) Limitation.--The total amount of civil money 
                penalties imposed under subparagraph (A) with respect to 
                each annual submission of information under subsection 
                (a) by an applicable manufacturer or applicable group 
                purchasing organization shall not exceed $1,000,000.
            ``(3) Use of funds.--Funds collected by the Secretary as a 
        result of the imposition of a civil money penalty under this 
        subsection shall be used to carry out this section.

    ``(c) Procedures for Submission of Information and Public 
Availability.--
            ``(1) In general.--

[[Page 124 STAT. 692]]

                    ``(A) <<NOTE: Deadline.>> Establishment.--Not later 
                than October 1, 2011, the Secretary shall establish 
                procedures--
                          ``(i) for applicable manufacturers and 
                      applicable group purchasing organizations to 
                      submit information to the Secretary under 
                      subsection (a); and
                          ``(ii) for the Secretary to make such 
                      information submitted available to the public.
                    ``(B) Definition of terms.--The procedures 
                established under subparagraph (A) shall provide for the 
                definition of terms (other than those terms defined in 
                subsection (e)), as appropriate, for purposes of this 
                section.
                    ``(C) <<NOTE: Deadlines. Web posting.>> Public 
                availability.--Except as provided in subparagraph (E), 
                the procedures established under subparagraph (A)(ii) 
                shall ensure that, not later than September 30, 2013, 
                and on June 30 of each calendar year beginning 
                thereafter, the information submitted under subsection 
                (a) with respect to the preceding calendar year is made 
                available through an Internet website that--
                          ``(i) is searchable and is in a format that is 
                      clear and understandable;
                          ``(ii) contains information that is presented 
                      by the name of the applicable manufacturer or 
                      applicable group purchasing organization, the name 
                      of the covered recipient, the business address of 
                      the covered recipient, the specialty of the 
                      covered recipient, the value of the payment or 
                      other transfer of value, the date on which the 
                      payment or other transfer of value was provided to 
                      the covered recipient, the form of the payment or 
                      other transfer of value, indicated (as 
                      appropriate) under subsection (a)(1)(A)(v), the 
                      nature of the payment or other transfer of value, 
                      indicated (as appropriate) under subsection 
                      (a)(1)(A)(vi), and the name of the covered drug, 
                      device, biological, or medical supply, as 
                      applicable;
                          ``(iii) contains information that is able to 
                      be easily aggregated and downloaded;
                          ``(iv) contains a description of any 
                      enforcement actions taken to carry out this 
                      section, including any penalties imposed under 
                      subsection (b), during the preceding year;
                          ``(v) contains background information on 
                      industry-physician relationships;
                          ``(vi) in the case of information submitted 
                      with respect to a payment or other transfer of 
                      value described in subparagraph (E)(i), lists such 
                      information separately from the other information 
                      submitted under subsection (a) and designates such 
                      separately listed information as funding for 
                      clinical research;
                          ``(vii) contains any other information the 
                      Secretary determines would be helpful to the 
                      average consumer;
                          ``(viii) does not contain the National 
                      Provider Identifier of the covered recipient, and
                          ``(ix) subject to subparagraph (D), provides 
                      the applicable manufacturer, applicable group 
                      purchasing organization, or covered recipient an 
                      opportunity to review and submit corrections to 
                      the information submitted with respect to the 
                      applicable manufacturer,

[[Page 124 STAT. 693]]

                      applicable group purchasing organization, or 
                      covered recipient, respectively, for a period of 
                      not less than 45 days prior to such information 
                      being made available to the public.
                    ``(D) Clarification of time period for review and 
                corrections.--In no case may the 45-day period for 
                review and submission of corrections to information 
                under subparagraph (C)(ix) prevent such information from 
                being made available to the public in accordance with 
                the dates described in the matter preceding clause (i) 
                in subparagraph (C).
                    ``(E) Delayed publication for payments made pursuant 
                to product research or development agreements and 
                clinical investigations.--
                          ``(i) In general.--In the case of information 
                      submitted under subsection (a) with respect to a 
                      payment or other transfer of value made to a 
                      covered recipient by an applicable manufacturer 
                      pursuant to a product research or development 
                      agreement for services furnished in connection 
                      with research on a potential new medical 
                      technology or a new application of an existing 
                      medical technology or the development of a new 
                      drug, device, biological, or medical supply, or by 
                      an applicable manufacturer in connection with a 
                      clinical investigation regarding a new drug, 
                      device, biological, or medical supply, the 
                      procedures established under subparagraph (A)(ii) 
                      shall provide that such information is made 
                      available to the public on the first date 
                      described in the matter preceding clause (i) in 
                      subparagraph (C) after the earlier of the 
                      following:
                                    ``(I) The date of the approval or 
                                clearance of the covered drug, device, 
                                biological, or medical supply by the 
                                Food and Drug Administration.
                                    ``(II) Four calendar years after the 
                                date such payment or other transfer of 
                                value was made.
                          ``(ii) Confidentiality of information prior to 
                      publication.--Information described in clause (i) 
                      shall be considered confidential and shall not be 
                      subject to disclosure under section 552 of title 
                      5, United States Code, or any other similar 
                      Federal, State, or local law, until on or after 
                      the date on which the information is made 
                      available to the public under such clause.
            ``(2) Consultation.--In establishing the procedures under 
        paragraph (1), the Secretary shall consult with the Inspector 
        General of the Department of Health and Human Services, affected 
        industry, consumers, consumer advocates, and other interested 
        parties in order to ensure that the information made available 
        to the public under such paragraph is presented in the 
        appropriate overall context.

    ``(d) Annual Reports and Relation to State Laws.--
            ``(1) Annual report to congress.--Not later than April 1 of 
        each year beginning with 2013, the Secretary shall submit to 
        Congress a report that includes the following:
                    ``(A) The information submitted under subsection (a) 
                during the preceding year, aggregated for each 
                applicable manufacturer and applicable group purchasing 
                organization that submitted such information during such 
                year

[[Page 124 STAT. 694]]

                (except, in the case of information submitted with 
                respect to a payment or other transfer of value 
                described in subsection (c)(1)(E)(i), such information 
                shall be included in the first report submitted to 
                Congress after the date on which such information is 
                made available to the public under such subsection).
                    ``(B) A description of any enforcement actions taken 
                to carry out this section, including any penalties 
                imposed under subsection (b), during the preceding year.
            ``(2) Annual reports to states.--Not later than September 
        30, 2013 and on June 30 of each calendar year thereafter, the 
        Secretary shall submit to States a report that includes a 
        summary of the information submitted under subsection (a) during 
        the preceding year with respect to covered recipients in the 
        State (except, in the case of information submitted with respect 
        to a payment or other transfer of value described in subsection 
        (c)(1)(E)(i), such information shall be included in the first 
        report submitted to States after the date on which such 
        information is made available to the public under such 
        subsection).
            ``(3) Relation to state laws.--
                    ``(A) In general.--In the case of a payment or other 
                transfer of value provided by an applicable manufacturer 
                that is received by a covered recipient (as defined in 
                subsection (e)) on or after January 1, 2012, subject to 
                subparagraph (B), the provisions of this section shall 
                preempt any statute or regulation of a State or of a 
                political subdivision of a State that requires an 
                applicable manufacturer (as so defined) to disclose or 
                report, in any format, the type of information (as 
                described in subsection (a)) regarding such payment or 
                other transfer of value.
                    ``(B) No preemption of additional requirements.--
                Subparagraph (A) shall not preempt any statute or 
                regulation of a State or of a political subdivision of a 
                State that requires the disclosure or reporting of 
                information--
                          ``(i) not of the type required to be disclosed 
                      or reported under this section;
                          ``(ii) described in subsection (e)(10)(B), 
                      except in the case of information described in 
                      clause (i) of such subsection;
                          ``(iii) by any person or entity other than an 
                      applicable manufacturer (as so defined) or a 
                      covered recipient (as defined in subsection (e)); 
                      or
                          ``(iv) to a Federal, State, or local 
                      governmental agency for public health 
                      surveillance, investigation, or other public 
                      health purposes or health oversight purposes.
                    ``(C) Nothing in subparagraph (A) shall be construed 
                to limit the discovery or admissibility of information 
                described in such subparagraph in a criminal, civil, or 
                administrative proceeding.
            ``(4) Consultation.--The Secretary shall consult with the 
        Inspector General of the Department of Health and Human Services 
        on the implementation of this section.

    ``(e) Definitions.--In this section:
            ``(1) Applicable group purchasing organization.--The term 
        `applicable group purchasing organization' means a group

[[Page 124 STAT. 695]]

        purchasing organization (as defined by the Secretary) that 
        purchases, arranges for, or negotiates the purchase of a covered 
        drug, device, biological, or medical supply which is operating 
        in the United States, or in a territory, possession, or 
        commonwealth of the United States.
            ``(2) Applicable manufacturer.--The term `applicable 
        manufacturer' means a manufacturer of a covered drug, device, 
        biological, or medical supply which is operating in the United 
        States, or in a territory, possession, or commonwealth of the 
        United States.
            ``(3) Clinical investigation.--The term `clinical 
        investigation' means any experiment involving 1 or more human 
        subjects, or materials derived from human subjects, in which a 
        drug or device is administered, dispensed, or used.
            ``(4) Covered device.--The term `covered device' means any 
        device for which payment is available under title XVIII or a 
        State plan under title XIX or XXI (or a waiver of such a plan).
            ``(5) Covered drug, device, biological, or medical supply.--
        The term `covered drug, device, biological, or medical supply' 
        means any drug, biological product, device, or medical supply 
        for which payment is available under title XVIII or a State plan 
        under title XIX or XXI (or a waiver of such a plan).
            ``(6) Covered recipient.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), the term `covered recipient' means the 
                following:
                          ``(i) A physician.
                          ``(ii) A teaching hospital.
                    ``(B) Exclusion.--Such term does not include a 
                physician who is an employee of the applicable 
                manufacturer that is required to submit information 
                under subsection (a).
            ``(7) Employee.--The term `employee' has the meaning given 
        such term in section 1877(h)(2).
            ``(8) Knowingly.--The term `knowingly' has the meaning given 
        such term in section 3729(b) of title 31, United States Code.
            ``(9) Manufacturer of a covered drug, device, biological, or 
        medical supply.--The term `manufacturer of a covered drug, 
        device, biological, or medical supply' means any entity which is 
        engaged in the production, preparation, propagation, 
        compounding, or conversion of a covered drug, device, 
        biological, or medical supply (or any entity under common 
        ownership with such entity which provides assistance or support 
        to such entity with respect to the production, preparation, 
        propagation, compounding, conversion, marketing, promotion, 
        sale, or distribution of a covered drug, device, biological, or 
        medical supply).
            ``(10) Payment or other transfer of value.--
                    ``(A) In general.--The term `payment or other 
                transfer of value' means a transfer of anything of 
                value. Such term does not include a transfer of anything 
                of value that is made indirectly to a covered recipient 
                through a third party in connection with an activity or 
                service in the case where the applicable manufacturer is 
                unaware of the identity of the covered recipient.

[[Page 124 STAT. 696]]

                    ``(B) Exclusions.--An applicable manufacturer shall 
                not be required to submit information under subsection 
                (a) with respect to the following:
                          ``(i) A transfer of anything the value of 
                      which is less than $10, unless the aggregate 
                      amount transferred to, requested by, or designated 
                      on behalf of the covered recipient by the 
                      applicable manufacturer during the calendar year 
                      exceeds $100. For calendar years after 2012, the 
                      dollar amounts specified in the preceding sentence 
                      shall be increased by the same percentage as the 
                      percentage increase in the consumer price index 
                      for all urban consumers (all items; U.S. city 
                      average) for the 12-month period ending with June 
                      of the previous year.
                          ``(ii) Product samples that are not intended 
                      to be sold and are intended for patient use.
                          ``(iii) Educational materials that directly 
                      benefit patients or are intended for patient use.
                          ``(iv) The loan of a covered device for a 
                      short-term trial period, not to exceed 90 days, to 
                      permit evaluation of the covered device by the 
                      covered recipient.
                          ``(v) Items or services provided under a 
                      contractual warranty, including the replacement of 
                      a covered device, where the terms of the warranty 
                      are set forth in the purchase or lease agreement 
                      for the covered device.
                          ``(vi) A transfer of anything of value to a 
                      covered recipient when the covered recipient is a 
                      patient and not acting in the professional 
                      capacity of a covered recipient.
                          ``(vii) Discounts (including rebates).
                          ``(viii) In-kind items used for the provision 
                      of charity care.
                          ``(ix) A dividend or other profit distribution 
                      from, or ownership or investment interest in, a 
                      publicly traded security and mutual fund (as 
                      described in section 1877(c)).
                          ``(x) In the case of an applicable 
                      manufacturer who offers a self-insured plan, 
                      payments for the provision of health care to 
                      employees under the plan.
                          ``(xi) In the case of a covered recipient who 
                      is a licensed non-medical professional, a transfer 
                      of anything of value to the covered recipient if 
                      the transfer is payment solely for the non-medical 
                      professional services of such licensed non-medical 
                      professional.
                          ``(xii) In the case of a covered recipient who 
                      is a physician, a transfer of anything of value to 
                      the covered recipient if the transfer is payment 
                      solely for the services of the covered recipient 
                      with respect to a civil or criminal action or an 
                      administrative proceeding.
            ``(11) Physician.--The term `physician' has the meaning 
        given that term in section 1861(r).''.

[[Page 124 STAT. 697]]

SEC. 6003. DISCLOSURE REQUIREMENTS FOR IN-OFFICE ANCILLARY SERVICES 
            EXCEPTION TO THE PROHIBITION ON PHYSICIAN SELF-REFERRAL FOR 
            CERTAIN IMAGING SERVICES.

    (a) In General.--Section 1877(b)(2) of the Social Security Act (42 
U.S.C. 1395nn(b)(2)) is amended by adding at the end the following new 
sentence: ``Such requirements shall, with respect to magnetic resonance 
imaging, computed tomography, positron emission tomography, and any 
other designated health services specified under subsection (h)(6)(D) 
that the Secretary determines appropriate, include a requirement that 
the referring physician inform the individual in writing at the time of 
the referral that the individual may obtain the services for which the 
individual is being referred from a person other than a person described 
in subparagraph (A)(i) and provide such individual with a written list 
of suppliers (as defined in section 1861(d)) who furnish such services 
in the area in which such individual resides.''.
    (b) Effective Date. <<NOTE: 42 USC 1395nn note.>> --The amendment 
made by this section shall apply to services furnished on or after 
January 1, 2010.

SEC. 6004. PRESCRIPTION DRUG SAMPLE TRANSPARENCY.

    Part A of title XI of the Social Security Act (42 U.S.C. 1301 et 
seq.), as amended by section 6002, is amended by inserting after section 
1128G the following new section:

``SEC. 1128H. <<NOTE: 42 USC 1320a-7i.>> REPORTING OF INFORMATION 
            RELATING TO DRUG SAMPLES.

    ``(a) In General.--Not later than April 1 of each year (beginning 
with 2012), each manufacturer and authorized distributor of record of an 
applicable drug shall submit to the Secretary (in a form and manner 
specified by the Secretary) the following information with respect to 
the preceding year:
            ``(1) In the case of a manufacturer or authorized 
        distributor of record which makes distributions by mail or 
        common carrier under subsection (d)(2) of section 503 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353), the 
        identity and quantity of drug samples requested and the identity 
        and quantity of drug samples distributed under such subsection 
        during that year, aggregated by--
                    ``(A) the name, address, professional designation, 
                and signature of the practitioner making the request 
                under subparagraph (A)(i) of such subsection, or of any 
                individual who makes or signs for the request on behalf 
                of the practitioner; and
                    ``(B) any other category of information determined 
                appropriate by the Secretary.
            ``(2) In the case of a manufacturer or authorized 
        distributor of record which makes distributions by means other 
        than mail or common carrier under subsection (d)(3) of such 
        section 503, the identity and quantity of drug samples requested 
        and the identity and quantity of drug samples distributed under 
        such subsection during that year, aggregated by--
                    ``(A) the name, address, professional designation, 
                and signature of the practitioner making the request 
                under subparagraph (A)(i) of such subsection, or of any 
                individual who makes or signs for the request on behalf 
                of the practitioner; and

[[Page 124 STAT. 698]]

                    ``(B) any other category of information determined 
                appropriate by the Secretary.

    ``(b) Definitions.--In this section:
            ``(1) Applicable drug.--The term `applicable drug' means a 
        drug--
                    ``(A) which is subject to subsection (b) of such 
                section 503; and
                    ``(B) for which payment is available under title 
                XVIII or a State plan under title XIX or XXI (or a 
                waiver of such a plan).
            ``(2) Authorized distributor of record.--The term 
        `authorized distributor of record' has the meaning given that 
        term in subsection (e)(3)(A) of such section.
            ``(3) Manufacturer.--The term `manufacturer' has the meaning 
        given that term for purposes of subsection (d) of such 
        section.''.

SEC. 6005. <<NOTE: 42 USC 1320b-23.>> PHARMACY BENEFIT MANAGERS 
            TRANSPARENCY REQUIREMENTS.

    Part A of title XI of the Social Security Act (42 U.S.C. 1301 et 
seq.) is amended by inserting after section 1150 the following new 
section:

``SEC. 1150A. PHARMACY BENEFIT MANAGERS TRANSPARENCY REQUIREMENTS.

    ``(a) Provision of Information.--A health benefits plan or any 
entity that provides pharmacy benefits management services on behalf of 
a health benefits plan (in this section referred to as a `PBM') that 
manages prescription drug coverage under a contract with--
            ``(1) a PDP sponsor of a prescription drug plan or an MA 
        organization offering an MA-PD plan under part D of title XVIII; 
        or
            ``(2) a qualified health benefits plan offered through an 
        exchange established by a State under section 1311 of the 
        Patient Protection and Affordable Care Act,

shall provide the information described in subsection (b) to the 
Secretary and, in the case of a PBM, to the plan with which the PBM is 
under contract with, at such times, and in such form and manner, as the 
Secretary shall specify.
    ``(b) Information Described.--The information described in this 
subsection is the following with respect to services provided by a 
health benefits plan or PBM for a contract year:
            ``(1) The percentage of all prescriptions that were provided 
        through retail pharmacies compared to mail order pharmacies, and 
        the percentage of prescriptions for which a generic drug was 
        available and dispensed (generic dispensing rate), by pharmacy 
        type (which includes an independent pharmacy, chain pharmacy, 
        supermarket pharmacy, or mass merchandiser pharmacy that is 
        licensed as a pharmacy by the State and that dispenses 
        medication to the general public), that is paid by the health 
        benefits plan or PBM under the contract.
            ``(2) The aggregate amount, and the type of rebates, 
        discounts, or price concessions (excluding bona fide service 
        fees, which include but are not limited to distribution service 
        fees, inventory management fees, product stocking allowances, 
        and fees associated with administrative services agreements and 
        patient care programs (such as medication compliance programs

[[Page 124 STAT. 699]]

        and patient education programs)) that the PBM negotiates that 
        are attributable to patient utilization under the plan, and the 
        aggregate amount of the rebates, discounts, or price concessions 
        that are passed through to the plan sponsor, and the total 
        number of prescriptions that were dispensed.
            ``(3) The aggregate amount of the difference between the 
        amount the health benefits plan pays the PBM and the amount that 
        the PBM pays retail pharmacies, and mail order pharmacies, and 
        the total number of prescriptions that were dispensed.

    ``(c) Confidentiality.--Information disclosed by a health benefits 
plan or PBM under this section is confidential and shall not be 
disclosed by the Secretary or by a plan receiving the information, 
except that the Secretary may disclose the information in a form which 
does not disclose the identity of a specific PBM, plan, or prices 
charged for drugs, for the following purposes:
            ``(1) As the Secretary determines to be necessary to carry 
        out this section or part D of title XVIII.
            ``(2) To permit the Comptroller General to review the 
        information provided.
            ``(3) To permit the Director of the Congressional Budget 
        Office to review the information provided.
            ``(4) To States to carry out section 1311 of the Patient 
        Protection and Affordable Care Act.

    ``(d) Penalties. <<NOTE: Applicability.>> --The provisions of 
subsection (b)(3)(C) of section 1927 shall apply to a health benefits 
plan or PBM that fails to provide information required under subsection 
(a) on a timely basis or that knowingly provides false information in 
the same manner as such provisions apply to a manufacturer with an 
agreement under that section.''.

          Subtitle B--Nursing Home Transparency and Improvement

              PART I--IMPROVING TRANSPARENCY OF INFORMATION

SEC. 6101. REQUIRED DISCLOSURE OF OWNERSHIP AND ADDITIONAL DISCLOSABLE 
            PARTIES INFORMATION.

    (a) In General.--Section 1124 of the Social Security Act (42 U.S.C. 
1320a-3) is amended by adding at the end the following new subsection:
    ``(c) Required Disclosure of Ownership and Additional Disclosable 
Parties Information.--
            ``(1) Disclosure.--A facility shall have the information 
        described in paragraph (2) available--
                    ``(A) <<NOTE: Time period.>> during the period 
                beginning on the date of the enactment of this 
                subsection and ending on the date such information is 
                made available to the public under section 6101(b) of 
                the Patient Protection and Affordable Care Act for 
                submission to the Secretary, the Inspector General of 
                the Department of Health and Human Services, the State 
                in which the facility is located, and the State long-
                term care ombudsman in the case where the Secretary, the

[[Page 124 STAT. 700]]

                Inspector General, the State, or the State long-term 
                care ombudsman requests such information; and
                    ``(B) beginning on the effective date of the final 
                regulations promulgated under paragraph (3)(A), for 
                reporting such information in accordance with such final 
                regulations.
        Nothing in subparagraph (A) shall be construed as authorizing a 
        facility to dispose of or delete information described in such 
        subparagraph after the effective date of the final regulations 
        promulgated under paragraph (3)(A).
            ``(2) Information described.--
                    ``(A) In general.--The following information is 
                described in this paragraph:
                          ``(i) The information described in subsections 
                      (a) and (b), subject to subparagraph (C).
                          ``(ii) The identity of and information on--
                                    ``(I) each member of the governing 
                                body of the facility, including the 
                                name, title, and period of service of 
                                each such member;
                                    ``(II) each person or entity who is 
                                an officer, director, member, partner, 
                                trustee, or managing employee of the 
                                facility, including the name, title, and 
                                period of service of each such person or 
                                entity; and
                                    ``(III) each person or entity who is 
                                an additional disclosable party of the 
                                facility.
                          ``(iii) The organizational structure of each 
                      additional disclosable party of the facility and a 
                      description of the relationship of each such 
                      additional disclosable party to the facility and 
                      to one another.
                    ``(B) Special rule where information is already 
                reported or submitted.--To the extent that information 
                reported by a facility to the Internal Revenue Service 
                on Form 990, information submitted by a facility to the 
                Securities and Exchange Commission, or information 
                otherwise submitted to the Secretary or any other 
                Federal agency contains the information described in 
                clauses (i), (ii), or (iii) of subparagraph (A), the 
                facility may provide such Form or such information 
                submitted to meet the requirements of paragraph (1).
                    ``(C) Special rule.--In applying subparagraph 
                (A)(i)--
                          ``(i) with respect to subsections (a) and (b), 
                      `ownership or control interest' shall include 
                      direct or indirect interests, including such 
                      interests in intermediate entities; and
                          ``(ii) subsection (a)(3)(A)(ii) shall include 
                      the owner of a whole or part interest in any 
                      mortgage, deed of trust, note, or other obligation 
                      secured, in whole or in part, by the entity or any 
                      of the property or assets thereof, if the interest 
                      is equal to or exceeds 5 percent of the total 
                      property or assets of the entirety.
            ``(3) Reporting.--
                    ``(A) In general. <<NOTE: Regulations. Effective 
                date. Federal Register, publication.>> --Not later than 
                the date that is 2 years after the date of the enactment 
                of this subsection, the Secretary shall promulgate final 
                regulations requiring, effective on the date that is 90 
                days after the date on which such final regulations are 
                published in the Federal Register, a facility to report 
                the information described in

[[Page 124 STAT. 701]]

                paragraph (2) to the Secretary in a standardized format, 
                and such other regulations as are necessary to carry out 
                this subsection. <<NOTE: Certification.>> Such final 
                regulations shall ensure that the facility certifies, as 
                a condition of participation and payment under the 
                program under title XVIII or XIX, that the information 
                reported by the facility in accordance with such final 
                regulations is, to the best of the facility's knowledge, 
                accurate and current.
                    ``(B) Guidance.--The Secretary shall provide 
                guidance and technical assistance to States on how to 
                adopt the standardized format under subparagraph (A).
            ``(4) No effect on existing reporting requirements.--Nothing 
        in this subsection shall reduce, diminish, or alter any 
        reporting requirement for a facility that is in effect as of the 
        date of the enactment of this subsection.
            ``(5) Definitions.--In this subsection:
                    ``(A) Additional disclosable party.--The term 
                `additional disclosable party' means, with respect to a 
                facility, any person or entity who--
                          ``(i) exercises operational, financial, or 
                      managerial control over the facility or a part 
                      thereof, or provides policies or procedures for 
                      any of the operations of the facility, or provides 
                      financial or cash management services to the 
                      facility;
                          ``(ii) leases or subleases real property to 
                      the facility, or owns a whole or part interest 
                      equal to or exceeding 5 percent of the total value 
                      of such real property; or
                          ``(iii) provides management or administrative 
                      services, management or clinical consulting 
                      services, or accounting or financial services to 
                      the facility.
                    ``(B) Facility.--The term `facility' means a 
                disclosing entity which is--
                          ``(i) a skilled nursing facility (as defined 
                      in section 1819(a)); or
                          ``(ii) a nursing facility (as defined in 
                      section 1919(a)).
                    ``(C) Managing employee.--The term `managing 
                employee' means, with respect to a facility, an 
                individual (including a general manager, business 
                manager, administrator, director, or consultant) who 
                directly or indirectly manages, advises, or supervises 
                any element of the practices, finances, or operations of 
                the facility.
                    ``(D) Organizational structure.--The term 
                `organizational structure' means, in the case of--
                          ``(i) a corporation, the officers, directors, 
                      and shareholders of the corporation who have an 
                      ownership interest in the corporation which is 
                      equal to or exceeds 5 percent;
                          ``(ii) a limited liability company, the 
                      members and managers of the limited liability 
                      company (including, as applicable, what percentage 
                      each member and manager has of the ownership 
                      interest in the limited liability company);
                          ``(iii) a general partnership, the partners of 
                      the general partnership;

[[Page 124 STAT. 702]]

                          ``(iv) a limited partnership, the general 
                      partners and any limited partners of the limited 
                      partnership who have an ownership interest in the 
                      limited partnership which is equal to or exceeds 
                      10 percent;
                          ``(v) a trust, the trustees of the trust;
                          ``(vi) an individual, contact information for 
                      the individual; and
                          ``(vii) any other person or entity, such 
                      information as the Secretary determines 
                      appropriate.''.

    (b) Public Availability of 
Information. <<NOTE: Deadline. Procedures. 42 USC 1320a-3 note.>> --Not 
later than the date that is 1 year after the date on which the final 
regulations promulgated under section 1124(c)(3)(A) of the Social 
Security Act, as added by subsection (a), are published in the Federal 
Register, the Secretary of Health and Human Services shall make the 
information reported in accordance with such final regulations available 
to the public in accordance with procedures established by the 
Secretary.

    (c) Conforming Amendments.--
            (1) In general.--
                    (A) Skilled nursing facilities.--Section 1819(d)(1) 
                of the Social Security Act (42 U.S.C. 1395i-3(d)(1)) is 
                amended by striking subparagraph (B) and redesignating 
                subparagraph (C) as subparagraph (B).
                    (B) Nursing facilities.--Section 1919(d)(1) of the 
                Social Security Act (42 U.S.C. 1396r(d)(1)) is amended 
                by striking subparagraph (B) and redesignating 
                subparagraph (C) as subparagraph (B).
            (2) <<NOTE: 42 USC 1395i-3 note.>> Effective date.--The 
        amendments made by paragraph (1) shall take effect on the date 
        on which the Secretary makes the information described in 
        subsection (b)(1) available to the public under such subsection.

SEC. 6102. ACCOUNTABILITY REQUIREMENTS FOR SKILLED NURSING FACILITIES 
            AND NURSING FACILITIES.

    Part A of title XI of the Social Security Act (42 U.S.C. 1301 et 
seq.), as amended by sections 6002 and 6004, is amended by inserting 
after section 1128H the following new section:

``SEC. 1128I. <<NOTE: 42 USC 1320a-7j.>> ACCOUNTABILITY REQUIREMENTS FOR 
            FACILITIES.

    ``(a) Definition of Facility.--In this section, the term `facility' 
means--
            ``(1) a skilled nursing facility (as defined in section 
        1819(a)); or
            ``(2) a nursing facility (as defined in section 1919(a)).

    ``(b) Effective Compliance and Ethics Programs.--
            ``(1) Requirement. <<NOTE: Effective date.>> --On or after 
        the date that is 36 months after the date of the enactment of 
        this section, a facility shall, with respect to the entity that 
        operates the facility (in this subparagraph referred to as the 
        `operating organization' or `organization'), have in operation a 
        compliance and ethics program that is effective in preventing 
        and detecting criminal, civil, and administrative violations 
        under this Act and in promoting quality of care consistent with 
        regulations developed under paragraph (2).
            ``(2) <<NOTE: Deadlines.>> Development of regulations.--
                    ``(A) In general.--Not later than the date that is 2 
                years after such date of the enactment, the Secretary,

[[Page 124 STAT. 703]]

                working jointly with the Inspector General of the 
                Department of Health and Human Services, shall 
                promulgate regulations for an effective compliance and 
                ethics program for operating organizations, which may 
                include a model compliance program.
                    ``(B)  Design of regulations.--Such regulations with 
                respect to specific elements or formality of a program 
                shall, in the case of an organization that operates 5 or 
                more facilities, vary with the size of the organization, 
                such that larger organizations should have a more formal 
                program and include established written policies 
                defining the standards and procedures to be followed by 
                its employees. Such requirements may specifically apply 
                to the corporate level management of multi unit nursing 
                home chains.
                    ``(C) Evaluation.--Not later than 3 years after the 
                date of the promulgation of regulations under this 
                paragraph, the Secretary shall complete an evaluation of 
                the compliance and ethics programs required to be 
                established under this subsection. Such evaluation shall 
                determine if such programs led to changes in deficiency 
                citations, changes in quality performance, or changes in 
                other metrics of patient quality of 
                care. <<NOTE: Reports.>> The Secretary shall submit to 
                Congress a report on such evaluation and shall include 
                in such report such recommendations regarding changes in 
                the requirements for such programs as the Secretary 
                determines appropriate.
            ``(3) Requirements for compliance and ethics 
        programs. <<NOTE: Definition.>> --In this subsection, the term 
        `compliance and ethics program' means, with respect to a 
        facility, a program of the operating organization that--
                    ``(A) has been reasonably designed, implemented, and 
                enforced so that it generally will be effective in 
                preventing and detecting criminal, civil, and 
                administrative violations under this Act and in 
                promoting quality of care; and
                    ``(B) includes at least the required components 
                specified in paragraph (4).
            ``(4) Required components of program.--The required 
        components of a compliance and ethics program of an operating 
        organization are the following:
                    ``(A) The organization must have established 
                compliance standards and procedures to be followed by 
                its employees and other agents that are reasonably 
                capable of reducing the prospect of criminal, civil, and 
                administrative violations under this Act.
                    ``(B) Specific individuals within high-level 
                personnel of the organization must have been assigned 
                overall responsibility to oversee compliance with such 
                standards and procedures and have sufficient resources 
                and authority to assure such compliance.
                    ``(C) The organization must have used due care not 
                to delegate substantial discretionary authority to 
                individuals whom the organization knew, or should have 
                known through the exercise of due diligence, had a 
                propensity to engage in criminal, civil, and 
                administrative violations under this Act.
                    ``(D) The organization must have taken steps to 
                communicate effectively its standards and procedures to 
                all

[[Page 124 STAT. 704]]

                employees and other agents, such as by requiring 
                participation in training programs or by disseminating 
                publications that explain in a practical manner what is 
                required.
                    ``(E) The organization must have taken reasonable 
                steps to achieve compliance with its standards, such as 
                by utilizing monitoring and auditing systems reasonably 
                designed to detect criminal, civil, and administrative 
                violations under this Act by its employees and other 
                agents and by having in place and publicizing a 
                reporting system whereby employees and other agents 
                could report violations by others within the 
                organization without fear of retribution.
                    ``(F) The standards must have been consistently 
                enforced through appropriate disciplinary mechanisms, 
                including, as appropriate, discipline of individuals 
                responsible for the failure to detect an offense.
                    ``(G) After an offense has been detected, the 
                organization must have taken all reasonable steps to 
                respond appropriately to the offense and to prevent 
                further similar offenses, including any necessary 
                modification to its program to prevent and detect 
                criminal, civil, and administrative violations under 
                this Act.
                    ``(H) The organization must periodically undertake 
                reassessment of its compliance program to identify 
                changes necessary to reflect changes within the 
                organization and its facilities.

    ``(c) Quality Assurance and Performance Improvement Program.--
            ``(1) In general. <<NOTE: Deadlines.>> --Not later than 
        December 31, 2011, the Secretary shall establish and implement a 
        quality assurance and performance improvement program (in this 
        subparagraph referred to as the `QAPI program') for facilities, 
        including multi unit chains of 
        facilities. <<NOTE: Standards.>> Under the QAPI program, the 
        Secretary shall establish standards relating to quality 
        assurance and performance improvement with respect to facilities 
        and provide technical assistance to facilities on the 
        development of best practices in order to meet such 
        standards. <<NOTE: Plan.>> Not later than 1 year after the date 
        on which the regulations are promulgated under paragraph (2), a 
        facility must submit to the Secretary a plan for the facility to 
        meet such standards and implement such best practices, including 
        how to coordinate the implementation of such plan with quality 
        assessment and assurance activities conducted under sections 
        1819(b)(1)(B) and 1919(b)(1)(B), as applicable.
            ``(2) Regulations.--The Secretary shall promulgate 
        regulations to carry out this subsection.''.

SEC. 6103. NURSING HOME COMPARE MEDICARE WEBSITE.

    (a) Skilled Nursing Facilities.--
            (1) In general.--Section 1819 of the Social Security Act (42 
        U.S.C. 1395i-3) is amended--
                    (A) by redesignating subsection (i) as subsection 
                (j); and
                    (B) by inserting after subsection (h) the following 
                new subsection:

    ``(i) Nursing Home Compare Website.--
            ``(1) Inclusion of additional information.--

[[Page 124 STAT. 705]]

                    ``(A) In general.--The Secretary shall ensure that 
                the Department of Health and Human Services includes, as 
                part of the information provided for comparison of 
                nursing homes on the official Internet website of the 
                Federal Government for Medicare beneficiaries (commonly 
                referred to as the `Nursing Home Compare' Medicare 
                website) (or a successor website), the following 
                information in a manner that is prominent, updated on a 
                timely basis, easily accessible, readily understandable 
                to consumers of long-term care services, and searchable:
                          ``(i) Staffing data for each facility 
                      (including resident census data and data on the 
                      hours of care provided per resident per day) based 
                      on data submitted under section 1128I(g), 
                      including information on staffing turnover and 
                      tenure, in a format that is clearly understandable 
                      to consumers of long-term care services and allows 
                      such consumers to compare differences in staffing 
                      between facilities and State and national averages 
                      for the facilities. Such format shall include--
                                    ``(I) concise explanations of how to 
                                interpret the data (such as a plain 
                                English explanation of data reflecting 
                                `nursing home staff hours per resident 
                                day');
                                    ``(II) differences in types of staff 
                                (such as training associated with 
                                different categories of staff);
                                    ``(III) the relationship between 
                                nurse staffing levels and quality of 
                                care; and
                                    ``(IV) an explanation that 
                                appropriate staffing levels vary based 
                                on patient case mix.
                          ``(ii) Links to State Internet websites with 
                      information regarding State survey and 
                      certification programs, links to Form 2567 State 
                      inspection reports (or a successor form) on such 
                      websites, information to guide consumers in how to 
                      interpret and understand such reports, and the 
                      facility plan of correction or other response to 
                      such report. Any such links shall be posted on a 
                      timely basis.
                          ``(iii) The standardized complaint form 
                      developed under section 1128I(f), including 
                      explanatory material on what complaint forms are, 
                      how they are used, and how to file a complaint 
                      with the State survey and certification program 
                      and the State long-term care ombudsman program.
                          ``(iv) Summary information on the number, 
                      type, severity, and outcome of substantiated 
                      complaints.
                          ``(v) The number of adjudicated instances of 
                      criminal violations by a facility or the employees 
                      of a facility--
                                    ``(I) that were committed inside the 
                                facility;
                                    ``(II) with respect to such 
                                instances of violations or crimes 
                                committed inside of the facility that 
                                were the violations or crimes of abuse, 
                                neglect, and exploitation, criminal 
                                sexual abuse, or other violations or 
                                crimes that resulted in serious bodily 
                                injury; and

[[Page 124 STAT. 706]]

                                    ``(III) the number of civil monetary 
                                penalties levied against the facility, 
                                employees, contractors, and other 
                                agents.
                    ``(B) Deadline for provision of information.--
                          ``(i) In general.--Except as provided in 
                      clause (ii), the Secretary shall ensure that the 
                      information described in subparagraph (A) is 
                      included on such website (or a successor website) 
                      not later than 1 year after the date of the 
                      enactment of this subsection.
                          ``(ii) Exception.--The Secretary shall ensure 
                      that the information described in subparagraph 
                      (A)(i) is included on such website (or a successor 
                      website) not later than the date on which the 
                      requirements under section 1128I(g) are 
                      implemented.
            ``(2) Review and modification of website.--
                    ``(A) In general. <<NOTE: Procedures.>> --The 
                Secretary shall establish a process--
                          ``(i) to review the accuracy, clarity of 
                      presentation, timeliness, and comprehensiveness of 
                      information reported on such website as of the day 
                      before the date of the enactment of this 
                      subsection; and
                          ``(ii) <<NOTE: Deadline.>> not later than 1 
                      year after the date of the enactment of this 
                      subsection, to modify or revamp such website in 
                      accordance with the review conducted under clause 
                      (i).
                    ``(B) Consultation.--In conducting the review under 
                subparagraph (A)(i), the Secretary shall consult with--
                          ``(i) State long-term care ombudsman programs;
                          ``(ii) consumer advocacy groups;
                          ``(iii) provider stakeholder groups; and
                          ``(iv) any other representatives of programs 
                      or groups the Secretary determines appropriate.''.
            (2) Timeliness of submission of survey and certification 
        information.--
                    (A) In general.--Section 1819(g)(5) of the Social 
                Security Act (42 U.S.C. 1395i-3(g)(5)) is amended by 
                adding at the end the following new subparagraph:
                    ``(E) Submission of survey and certification 
                information to the secretary.--In order to improve the 
                timeliness of information made available to the public 
                under subparagraph (A) and provided on the Nursing Home 
                Compare Medicare website under subsection (i), each 
                State shall submit information respecting any survey or 
                certification made respecting a skilled nursing facility 
                (including any enforcement actions taken by the State) 
                to the Secretary not later than the date on which the 
                State sends such information to the facility. The 
                Secretary shall use the information submitted under the 
                preceding sentence to update the information provided on 
                the Nursing Home Compare Medicare website as 
                expeditiously as practicable but not less frequently 
                than quarterly.''.
                    (B) <<NOTE: 42 USC 1395i-3 note.>> Effective date.--
                The amendment made by this paragraph shall take effect 1 
                year after the date of the enactment of this Act.
            (3) Special focus facility program.--Section 1819(f) of the 
        Social Security Act (42 U.S.C. 1395i-3(f)) is amended by adding 
        at the end the following new paragraph:

[[Page 124 STAT. 707]]

            ``(8) Special focus facility program.--
                    ``(A) In general.--The Secretary shall conduct a 
                special focus facility program for enforcement of 
                requirements for skilled nursing facilities that the 
                Secretary has identified as having substantially failed 
                to meet applicable requirement of this Act.
                    ``(B) Periodic surveys.--Under such program the 
                Secretary shall conduct surveys of each facility in the 
                program not less than once every 6 months.''.

    (b) Nursing Facilities.--
            (1) In general.--Section 1919 of the Social Security Act (42 
        U.S.C. 1396r) is amended--
                    (A) by redesignating subsection (i) as subsection 
                (j); and
                    (B) by inserting after subsection (h) the following 
                new subsection:

    ``(i) Nursing Home Compare Website.--
            ``(1) Inclusion of additional information.--
                    ``(A) In general.--The Secretary shall ensure that 
                the Department of Health and Human Services includes, as 
                part of the information provided for comparison of 
                nursing homes on the official Internet website of the 
                Federal Government for Medicare beneficiaries (commonly 
                referred to as the `Nursing Home Compare' Medicare 
                website) (or a successor website), the following 
                information in a manner that is prominent, updated on a 
                timely basis, easily accessible, readily understandable 
                to consumers of long-term care services, and searchable:
                          ``(i) Staffing data for each facility 
                      (including resident census data and data on the 
                      hours of care provided per resident per day) based 
                      on data submitted under section 1128I(g), 
                      including information on staffing turnover and 
                      tenure, in a format that is clearly understandable 
                      to consumers of long-term care services and allows 
                      such consumers to compare differences in staffing 
                      between facilities and State and national averages 
                      for the facilities. Such format shall include--
                                    ``(I) concise explanations of how to 
                                interpret the data (such as plain 
                                English explanation of data reflecting 
                                `nursing home staff hours per resident 
                                day');
                                    ``(II) differences in types of staff 
                                (such as training associated with 
                                different categories of staff);
                                    ``(III) the relationship between 
                                nurse staffing levels and quality of 
                                care; and
                                    ``(IV) an explanation that 
                                appropriate staffing levels vary based 
                                on patient case mix.
                          ``(ii) Links to State Internet websites with 
                      information regarding State survey and 
                      certification programs, links to Form 2567 State 
                      inspection reports (or a successor form) on such 
                      websites, information to guide consumers in how to 
                      interpret and understand such reports, and the 
                      facility plan of correction or other response to 
                      such report. Any such links shall be posted on a 
                      timely basis.

[[Page 124 STAT. 708]]

                          ``(iii) The standardized complaint form 
                      developed under section 1128I(f), including 
                      explanatory material on what complaint forms are, 
                      how they are used, and how to file a complaint 
                      with the State survey and certification program 
                      and the State long-term care ombudsman program.
                          ``(iv) Summary information on the number, 
                      type, severity, and outcome of substantiated 
                      complaints.
                          ``(v) The number of adjudicated instances of 
                      criminal violations by a facility or the employees 
                      of a facility--
                                    ``(I) that were committed inside of 
                                the facility; and
                                    ``(II) with respect to such 
                                instances of violations or crimes 
                                committed outside of the facility, that 
                                were violations or crimes that resulted 
                                in the serious bodily injury of an 
                                elder.
                    ``(B) Deadline for provision of information.--
                          ``(i) In general.--Except as provided in 
                      clause (ii), the Secretary shall ensure that the 
                      information described in subparagraph (A) is 
                      included on such website (or a successor website) 
                      not later than 1 year after the date of the 
                      enactment of this subsection.
                          ``(ii) Exception.--The Secretary shall ensure 
                      that the information described in subparagraph 
                      (A)(i) is included on such website (or a successor 
                      website) not later than the date on which the 
                      requirements under section 1128I(g) are 
                      implemented.
            ``(2) Review and modification of website.--
                    ``(A) In general. <<NOTE: Procedures.>> --The 
                Secretary shall establish a process--
                          ``(i) to review the accuracy, clarity of 
                      presentation, timeliness, and comprehensiveness of 
                      information reported on such website as of the day 
                      before the date of the enactment of this 
                      subsection; and
                          ``(ii) <<NOTE: Deadline.>> not later than 1 
                      year after the date of the enactment of this 
                      subsection, to modify or revamp such website in 
                      accordance with the review conducted under clause 
                      (i).
                    ``(B) Consultation.--In conducting the review under 
                subparagraph (A)(i), the Secretary shall consult with--
                          ``(i) State long-term care ombudsman programs;
                          ``(ii) consumer advocacy groups;
                          ``(iii) provider stakeholder groups;
                          ``(iv) skilled nursing facility employees and 
                      their representatives; and
                          ``(v) any other representatives of programs or 
                      groups the Secretary determines appropriate.''.
            (2) Timeliness of submission of survey and certification 
        information.--
                    (A) In general.--Section 1919(g)(5) of the Social 
                Security Act (42 U.S.C. 1396r(g)(5)) is amended by 
                adding at the end the following new subparagraph:
                    ``(E) <<NOTE: Deadline.>> Submission of survey and 
                certification information to the secretary.--In order to 
                improve the timeliness of information made available to 
                the public under subparagraph (A) and provided on the 
                Nursing Home

[[Page 124 STAT. 709]]

                Compare Medicare website under subsection (i), each 
                State shall submit information respecting any survey or 
                certification made respecting a nursing facility 
                (including any enforcement actions taken by the State) 
                to the Secretary not later than the date on which the 
                State sends such information to the facility. The 
                Secretary shall use the information submitted under the 
                preceding sentence to update the information provided on 
                the Nursing Home Compare Medicare website as 
                expeditiously as practicable but not less frequently 
                than quarterly.''.
                    (B) Effective date. <<NOTE: 42 USC 1396r note.>> --
                The amendment made by this paragraph shall take effect 1 
                year after the date of the enactment of this Act.
            (3) Special focus facility program.--Section 1919(f) of the 
        Social Security Act (42 U.S.C. 1396r(f)) is amended by adding at 
        the end of the following new paragraph:
            ``(10) Special focus facility program.--
                    ``(A) In general.--The Secretary shall conduct a 
                special focus facility program for enforcement of 
                requirements for nursing facilities that the Secretary 
                has identified as having substantially failed to meet 
                applicable requirements of this Act.
                    ``(B) Periodic surveys.--Under such program the 
                Secretary shall conduct surveys of each facility in the 
                program not less often than once every 6 months.''.

    (c) Availability of Reports on Surveys, Certifications, and 
Complaint Investigations.--
            (1) Skilled nursing facilities.--Section 1819(d)(1) of the 
        Social Security Act (42 U.S.C. 1395i-3(d)(1)), as amended by 
        section 6101, is amended by adding at the end the following new 
        subparagraph:
                    ``(C) Availability of survey, certification, and 
                complaint investigation reports.--A skilled nursing 
                facility must--
                          ``(i) have reports with respect to any 
                      surveys, certifications, and complaint 
                      investigations made respecting the facility during 
                      the 3 preceding years available for any individual 
                      to review upon request; and
                          ``(ii) <<NOTE: Public information.>> post 
                      notice of the availability of such reports in 
                      areas of the facility that are prominent and 
                      accessible to the public.
                The facility shall not make available under clause (i) 
                identifying information about complainants or 
                residents.''.
            (2) Nursing facilities.--Section 1919(d)(1) of the Social 
        Security Act (42 U.S.C. 1396r(d)(1)), as amended by section 
        6101, is amended by adding at the end the following new 
        subparagraph:
                    ``(V) Availability of survey, certification, and 
                complaint investigation reports.--A nursing facility 
                must--
                          ``(i) have reports with respect to any 
                      surveys, certifications, and complaint 
                      investigations made respecting the facility during 
                      the 3 preceding years available for any individual 
                      to review upon request; and

[[Page 124 STAT. 710]]

                          ``(ii) <<NOTE: Public information.>> post 
                      notice of the availability of such reports in 
                      areas of the facility that are prominent and 
                      accessible to the public.
                The facility shall not make available under clause (i) 
                identifying information about complainants or 
                residents.''.
            (3) Effective date. <<NOTE: 42 USC 1395i-3 note.>> --The 
        amendments made by this subsection shall take effect 1 year 
        after the date of the enactment of this Act.

    (d) Guidance to States on Form 2567 State Inspection Reports and 
Complaint Investigation Reports.--
            (1) Guidance. <<NOTE: 42 USC 1395i-3 note. Web posting.>> --
        The Secretary of Health and Human Services (in this subtitle 
        referred to as the ``Secretary'') shall provide guidance to 
        States on how States can establish electronic links to Form 2567 
        State inspection reports (or a successor form), complaint 
        investigation reports, and a facility's plan of correction or 
        other response to such Form 2567 State inspection reports (or a 
        successor form) on the Internet website of the State that 
        provides information on skilled nursing facilities and nursing 
        facilities and the Secretary shall, if possible, include such 
        information on Nursing Home Compare.
            (2) Requirement.--Section 1902(a)(9) of the Social Security 
        Act (42 U.S.C. 1396a(a)(9)) is amended--
                    (A) by striking ``and'' at the end of subparagraph 
                (B);
                    (B) by striking the semicolon at the end of 
                subparagraph (C) and inserting ``, and''; and
                    (C) by adding at the end the following new 
                subparagraph:
                    ``(D) that the State maintain a consumer-oriented 
                website providing useful information to consumers 
                regarding all skilled nursing facilities and all nursing 
                facilities in the State, including for each facility, 
                Form 2567 State inspection reports (or a successor 
                form), complaint investigation reports, the facility's 
                plan of correction, and such other information that the 
                State or the Secretary considers useful in assisting the 
                public to assess the quality of long term care options 
                and the quality of care provided by individual 
                facilities;''.
            (3) <<NOTE: 42 USC 1395i-3 note.>> Definitions.--In this 
        subsection:
                    (A) Nursing facility.--The term ``nursing facility'' 
                has the meaning given such term in section 1919(a) of 
                the Social Security Act (42 U.S.C. 1396r(a)).
                    (B) Secretary.--The term ``Secretary'' means the 
                Secretary of Health and Human Services.
                    (C) Skilled nursing facility.--The term ``skilled 
                nursing facility'' has the meaning given such term in 
                section 1819(a) of the Social Security Act (42 U.S.C. 
                1395i-3(a)).

    (e) <<NOTE: 42 USC 1395i-3 note. Deadline.>> Development of Consumer 
Rights Information Page on Nursing Home Compare Website.--Not later than 
1 year after the date of enactment of this Act, the Secretary shall 
ensure that the Department of Health and Human Services, as part of the 
information provided for comparison of nursing facilities on the Nursing 
Home Compare Medicare website develops and includes a consumer rights 
information page that contains links to descriptions of, and information 
with respect to, the following:
            (1) The documentation on nursing facilities that is 
        available to the public.

[[Page 124 STAT. 711]]

            (2) General information and tips on choosing a nursing 
        facility that meets the needs of the individual.
            (3) General information on consumer rights with respect to 
        nursing facilities.
            (4) The nursing facility survey process (on a national and 
        State-specific basis).
            (5) On a State-specific basis, the services available 
        through the State long-term care ombudsman for such State.

SEC. 6104. REPORTING OF EXPENDITURES.

    Section 1888 of the Social Security Act (42 U.S.C. 1395yy) is 
amended by adding at the end the following new subsection:
    ``(f) Reporting of Direct Care Expenditures.--
            ``(1) In general.--For cost reports submitted under this 
        title for cost reporting periods beginning on or after the date 
        that is 2 years after the date of the enactment of this 
        subsection, skilled nursing facilities shall separately report 
        expenditures for wages and benefits for direct care staff 
        (breaking out (at a minimum) registered nurses, licensed 
        professional nurses, certified nurse assistants, and other 
        medical and therapy staff).
            ``(2) Modification of form.--The Secretary, in consultation 
        with private sector accountants experienced with Medicare and 
        Medicaid nursing facility home cost reports, shall redesign such 
        reports to meet the requirement of paragraph (1) not later than 
        1 year after the date of the enactment of this subsection.
            ``(3) Categorization by functional accounts.--Not later than 
        30 months after the date of the enactment of this subsection, 
        the Secretary, working in consultation with the Medicare Payment 
        Advisory Commission, the Medicaid and CHIP Payment and Access 
        Commission, the Inspector General of the Department of Health 
        and Human Services, and other expert parties the Secretary 
        determines appropriate, shall take the expenditures listed on 
        cost reports, as modified under paragraph (1), submitted by 
        skilled nursing facilities and categorize such expenditures, 
        regardless of any source of payment for such expenditures, for 
        each skilled nursing facility into the following functional 
        accounts on an annual basis:
                    ``(A) Spending on direct care services (including 
                nursing, therapy, and medical services).
                    ``(B) Spending on indirect care (including 
                housekeeping and dietary services).
                    ``(C) Capital assets (including building and land 
                costs).
                    ``(D) Administrative services costs.
            ``(4) Availability of information 
        submitted. <<NOTE: Procedures.>> --The Secretary shall establish 
        procedures to make information on expenditures submitted under 
        this subsection readily available to interested parties upon 
        request, subject to such requirements as the Secretary may 
        specify under the procedures established under this 
        paragraph.''.

SEC. 6105. STANDARDIZED COMPLAINT FORM.

    (a) In General.--Section 1128I of the Social Security Act, as added 
and amended by this Act, is amended by adding at the end the following 
new subsection:
    ``(f) <<NOTE: 42 USC 1320a-7j.>>  Standardized Complaint Form.--
            ``(1) Development by the secretary.--The Secretary shall 
        develop a standardized complaint form for use by a resident

[[Page 124 STAT. 712]]

        (or a person acting on the resident's behalf) in filing a 
        complaint with a State survey and certification agency and a 
        State long-term care ombudsman program with respect to a 
        facility.
            ``(2) Complaint forms and resolution processes.--
                    ``(A) Complaint forms.--The State must make the 
                standardized complaint form developed under paragraph 
                (1) available upon request to--
                          ``(i) a resident of a facility; and
                          ``(ii) any person acting on the resident's 
                      behalf.
                    ``(B) Complaint resolution process.--The State must 
                establish a complaint resolution process in order to 
                ensure that the legal representative of a resident of a 
                facility or other responsible party is not denied access 
                to such resident or otherwise retaliated against if they 
                have complained about the quality of care provided by 
                the facility or other issues relating to the facility. 
                Such complaint resolution process shall include--
                          ``(i) procedures to assure accurate tracking 
                      of complaints received, including notification to 
                      the complainant that a complaint has been 
                      received;
                          ``(ii) procedures to determine the likely 
                      severity of a complaint and for the investigation 
                      of the complaint; and
                          ``(iii) deadlines for responding to a 
                      complaint and for notifying the complainant of the 
                      outcome of the investigation.
            ``(3) Rule of construction.--Nothing in this subsection 
        shall be construed as preventing a resident of a facility (or a 
        person acting on the resident's behalf) from submitting a 
        complaint in a manner or format other than by using the 
        standardized complaint form developed under paragraph (1) 
        (including submitting a complaint orally).''.

    (b) <<NOTE: 42 USC 1320a-7j note.>> Effective Date.--The amendment 
made by this section shall take effect 1 year after the date of the 
enactment of this Act.

SEC. 6106. ENSURING STAFFING ACCOUNTABILITY.

    Section 1128I of the Social Security Act, as added and amended by 
this Act, <<NOTE: 42 USC 1320a-7j.>> is amended by adding at the end the 
following new subsection:

    ``(g) Submission of Staffing Information Based on Payroll Data in a 
Uniform Format. <<NOTE: Deadline.>> --Beginning not later than 2 years 
after the date of the enactment of this subsection, and after consulting 
with State long-term care ombudsman programs, consumer advocacy groups, 
provider stakeholder groups, employees and their representatives, and 
other parties the Secretary deems appropriate, the Secretary shall 
require a facility to electronically submit to the Secretary direct care 
staffing information (including information with respect to agency and 
contract staff) based on payroll and other verifiable and auditable data 
in a uniform format (according to specifications established by the 
Secretary in consultation with such programs, groups, and parties). Such 
specifications shall require that the information submitted under the 
preceding sentence--
            ``(1) specify the category of work a certified employee 
        performs (such as whether the employee is a registered nurse,

[[Page 124 STAT. 713]]

        licensed practical nurse, licensed vocational nurse, certified 
        nursing assistant, therapist, or other medical personnel);
            ``(2) include resident census data and information on 
        resident case mix;
            ``(3) include a regular reporting schedule; and
            ``(4) include information on employee turnover and tenure 
        and on the hours of care provided by each category of certified 
        employees referenced in paragraph (1) per resident per day.

Nothing in this subsection shall be construed as preventing the 
Secretary from requiring submission of such information with respect to 
specific categories, such as nursing staff, before other categories of 
certified employees. Information under this subsection with respect to 
agency and contract staff shall be kept separate from information on 
employee staffing.''.

SEC. 6107. GAO STUDY AND REPORT ON FIVE-STAR QUALITY RATING SYSTEM.

    (a) Study.--The Comptroller General of the United States (in this 
section referred to as the ``Comptroller General'') shall conduct a 
study on the Five-Star Quality Rating System for nursing homes of the 
Centers for Medicare & Medicaid Services. Such study shall include an 
analysis of--
            (1) how such system is being implemented;
            (2) any problems associated with such system or its 
        implementation; and
            (3) how such system could be improved.

    (b) Report.--Not later than 2 years after the date of enactment of 
this Act, the Comptroller General shall submit to Congress a report 
containing the results of the study conducted under subsection (a), 
together with recommendations for such legislation and administrative 
action as the Comptroller General determines appropriate.

                     PART II--TARGETING ENFORCEMENT

SEC. 6111. CIVIL MONEY PENALTIES.

    (a) Skilled Nursing Facilities.--
            (1) In general.--Section 1819(h)(2)(B)(ii) of the Social 
        Security Act (42 U.S.C. 1395i-3(h)(2)(B)(ii)) is amended--
                    (A) by striking ``Penalties.--The Secretary'' and 
                inserting ``penalties.--
                                    ``(I) In general.--Subject to 
                                subclause (II), the Secretary''; and
                    (B) by adding at the end the following new 
                subclauses:
                                    ``(II) Reduction of civil money 
                                penalties in certain 
                                circumstances. <<NOTE: Deadline.>> --
                                Subject to subclause (III), in the case 
                                where a facility self-reports and 
                                promptly corrects a deficiency for which 
                                a penalty was imposed under this clause 
                                not later than 10 calendar days after 
                                the date of such imposition, the 
                                Secretary may reduce the amount of the 
                                penalty imposed by not more than 50 
                                percent.
                                    ``(III) Prohibitions on reduction 
                                for certain deficiencies.--
                                            ``(aa) Repeat 
                                        deficiencies.--The Secretary may 
                                        not reduce the amount of a 
                                        penalty under subclause (II) if 
                                        the Secretary had

[[Page 124 STAT. 714]]

                                        reduced a penalty imposed on the 
                                        facility in the preceding year 
                                        under such subclause with 
                                        respect to a repeat deficiency.
                                            ``(bb) Certain other 
                                        deficiencies.--The Secretary may 
                                        not reduce the amount of a 
                                        penalty under subclause (II) if 
                                        the penalty is imposed on the 
                                        facility for a deficiency that 
                                        is found to result in a pattern 
                                        of harm or widespread harm, 
                                        immediately jeopardizes the 
                                        health or safety of a resident 
                                        or residents of the facility, or 
                                        results in the death of a 
                                        resident of the facility.
                                    ``(IV) Collection of civil money 
                                penalties. <<NOTE: Regulations.>> --In 
                                the case of a civil money penalty 
                                imposed under this clause, the Secretary 
                                shall issue regulations that--
                                            
                                        ``(aa) <<NOTE: Deadline.>> subjec
                                        t to item (cc), not later than 
                                        30 days after the imposition of 
                                        the penalty, provide for the 
                                        facility to have the opportunity 
                                        to participate in an independent 
                                        informal dispute resolution 
                                        process which generates a 
                                        written record prior to the 
                                        collection of such penalty;
                                            ``(bb) <<NOTE: Time 
                                        period.>> in the case where the 
                                        penalty is imposed for each day 
                                        of noncompliance, provide that a 
                                        penalty may not be imposed for 
                                        any day during the period 
                                        beginning on the initial day of 
                                        the imposition of the penalty 
                                        and ending on the day on which 
                                        the informal dispute resolution 
                                        process under item (aa) is 
                                        completed;
                                            ``(cc) may provide for the 
                                        collection of such civil money 
                                        penalty and the placement of 
                                        such amounts collected in an 
                                        escrow account under the 
                                        direction of the Secretary on 
                                        the earlier of the date on which 
                                        the informal dispute resolution 
                                        process under item (aa) is 
                                        completed or the date that is 90 
                                        days after the date of the 
                                        imposition of the penalty;
                                            ``(dd) may provide that such 
                                        amounts collected are kept in 
                                        such account pending the 
                                        resolution of any subsequent 
                                        appeals;
                                            ``(ee) in the case where the 
                                        facility successfully appeals 
                                        the penalty, may provide for the 
                                        return of such amounts collected 
                                        (plus interest) to the facility; 
                                        and
                                            ``(ff) in the case where all 
                                        such appeals are unsuccessful, 
                                        may provide that some portion of 
                                        such amounts collected may be 
                                        used to support activities that 
                                        benefit residents, including 
                                        assistance to support and 
                                        protect residents of a facility 
                                        that closes (voluntarily or 
                                        involuntarily) or is decertified 
                                        (including offsetting costs of 
                                        relocating residents to home and 
                                        community-based settings or 
                                        another facility), projects that 
                                        support resident and

[[Page 124 STAT. 715]]

                                        family councils and other 
                                        consumer involvement in assuring 
                                        quality care in facilities, and 
                                        facility improvement initiatives 
                                        approved by the Secretary 
                                        (including joint training of 
                                        facility staff and surveyors, 
                                        technical assistance for 
                                        facilities implementing quality 
                                        assurance programs, the 
                                        appointment of temporary 
                                        management firms, and other 
                                        activities approved by the 
                                        Secretary).''.
            (2) Conforming amendment.--The second sentence of section 
        1819(h)(5) of the Social Security Act (42 U.S.C. 1395i-3(h)(5)) 
        is amended by inserting ``(ii)(IV),'' after ``(i),''.

    (b) Nursing Facilities.--
            (1) In general.--Section 1919(h)(3)(C)(ii) of the Social 
        Security Act (42 U.S.C. 1396r(h)(3)(C)) is amended--
                    (A) by striking ``Penalties.--The Secretary'' and 
                inserting ``penalties.--
                                    ``(I) In general.--Subject to 
                                subclause (II), the Secretary''; and
                    (B) by adding at the end the following new 
                subclauses:
                                    ``(II) Reduction of civil money 
                                penalties in certain 
                                circumstances. <<NOTE: Deadline.>> --
                                Subject to subclause (III), in the case 
                                where a facility self-reports and 
                                promptly corrects a deficiency for which 
                                a penalty was imposed under this clause 
                                not later than 10 calendar days after 
                                the date of such imposition, the 
                                Secretary may reduce the amount of the 
                                penalty imposed by not more than 50 
                                percent.
                                    ``(III) Prohibitions on reduction 
                                for certain deficiencies.--
                                            ``(aa) Repeat 
                                        deficiencies.--The Secretary may 
                                        not reduce the amount of a 
                                        penalty under subclause (II) if 
                                        the Secretary had reduced a 
                                        penalty imposed on the facility 
                                        in the preceding year under such 
                                        subclause with respect to a 
                                        repeat deficiency.
                                            ``(bb) Certain other 
                                        deficiencies.--The Secretary may 
                                        not reduce the amount of a 
                                        penalty under subclause (II) if 
                                        the penalty is imposed on the 
                                        facility for a deficiency that 
                                        is found to result in a pattern 
                                        of harm or widespread harm, 
                                        immediately jeopardizes the 
                                        health or safety of a resident 
                                        or residents of the facility, or 
                                        results in the death of a 
                                        resident of the facility.
                                    ``(IV) Collection of civil money 
                                penalties. <<NOTE: Regulations.>> --In 
                                the case of a civil money penalty 
                                imposed under this clause, the Secretary 
                                shall issue regulations that--
                                            
                                        ``(aa) <<NOTE: Deadline.>> subjec
                                        t to item (cc), not later than 
                                        30 days after the imposition of 
                                        the penalty, provide for the 
                                        facility to have the opportunity 
                                        to participate in an independent 
                                        informal dispute resolution 
                                        process which generates a 
                                        written record prior to the 
                                        collection of such penalty;

[[Page 124 STAT. 716]]

                                            ``(bb) <<NOTE: Time 
                                        period.>> in the case where the 
                                        penalty is imposed for each day 
                                        of noncompliance, provide that a 
                                        penalty may not be imposed for 
                                        any day during the period 
                                        beginning on the initial day of 
                                        the imposition of the penalty 
                                        and ending on the day on which 
                                        the informal dispute resolution 
                                        process under item (aa) is 
                                        completed;
                                            ``(cc) may provide for the 
                                        collection of such civil money 
                                        penalty and the placement of 
                                        such amounts collected in an 
                                        escrow account under the 
                                        direction of the Secretary on 
                                        the earlier of the date on which 
                                        the informal dispute resolution 
                                        process under item (aa) is 
                                        completed or the date that is 90 
                                        days after the date of the 
                                        imposition of the penalty;
                                            ``(dd) may provide that such 
                                        amounts collected are kept in 
                                        such account pending the 
                                        resolution of any subsequent 
                                        appeals;
                                            ``(ee) in the case where the 
                                        facility successfully appeals 
                                        the penalty, may provide for the 
                                        return of such amounts collected 
                                        (plus interest) to the facility; 
                                        and
                                            ``(ff) in the case where all 
                                        such appeals are unsuccessful, 
                                        may provide that some portion of 
                                        such amounts collected may be 
                                        used to support activities that 
                                        benefit residents, including 
                                        assistance to support and 
                                        protect residents of a facility 
                                        that closes (voluntarily or 
                                        involuntarily) or is decertified 
                                        (including offsetting costs of 
                                        relocating residents to home and 
                                        community-based settings or 
                                        another facility), projects that 
                                        support resident and family 
                                        councils and other consumer 
                                        involvement in assuring quality 
                                        care in facilities, and facility 
                                        improvement initiatives approved 
                                        by the Secretary (including 
                                        joint training of facility staff 
                                        and surveyors, technical 
                                        assistance for facilities 
                                        implementing quality assurance 
                                        programs, the appointment of 
                                        temporary management firms, and 
                                        other activities approved by the 
                                        Secretary).''.
            (2) Conforming amendment.--Section 1919(h)(5)(8) of the 
        Social Security Act (42 U.S.C. 1396r(h)(5)(8)) is amended by 
        inserting ``(ii)(IV),'' after ``(i),''.

    (c) <<NOTE: 42 USC 1395i-3 note.>> Effective Date.--The amendments 
made by this section shall take effect 1 year after the date of the 
enactment of this Act.

SEC. 6112. <<NOTE: 42 USC 1320a-7j note.>> NATIONAL INDEPENDENT MONITOR 
            DEMONSTRATION PROJECT.

    (a) Establishment.--
            (1) In general.--The Secretary, in consultation with the 
        Inspector General of the Department of Health and Human 
        Services, shall conduct a demonstration project to develop, 
        test, and implement an independent monitor program to oversee

[[Page 124 STAT. 717]]

        interstate and large intrastate chains of skilled nursing 
        facilities and nursing facilities.
            (2) Selection.--The Secretary shall select chains of skilled 
        nursing facilities and nursing facilities described in paragraph 
        (1) to participate in the demonstration project under this 
        section from among those chains that submit an application to 
        the Secretary at such time, in such manner, and containing such 
        information as the Secretary may require.
            (3) Duration.--The Secretary shall conduct the demonstration 
        project under this section for a 2-year period.
            (4) Implementation. <<NOTE: Deadline.>> --The Secretary 
        shall implement the demonstration project under this section not 
        later than 1 year after the date of the enactment of this Act.

    (b) Requirements. <<NOTE: Evaluation.>> --The Secretary shall 
evaluate chains selected to participate in the demonstration project 
under this section based on criteria selected by the Secretary, 
including where evidence suggests that a number of the facilities of the 
chain are experiencing serious safety and quality of care problems. Such 
criteria may include the evaluation of a chain that includes a number of 
facilities participating in the ``Special Focus Facility'' program (or a 
successor program) or multiple facilities with a record of repeated 
serious safety and quality of care deficiencies.

    (c) Responsibilities. <<NOTE: Contracts.>> --An independent monitor 
that enters into a contract with the Secretary to participate in the 
conduct of the demonstration project under this section shall--
            (1) <<NOTE: Review.>> conduct periodic reviews and prepare 
        root-cause quality and deficiency analyses of a chain to assess 
        if facilities of the chain are in compliance with State and 
        Federal laws and regulations applicable to the facilities;
            (2) conduct sustained oversight of the efforts of the chain, 
        whether publicly or privately held, to achieve compliance by 
        facilities of the chain with State and Federal laws and 
        regulations applicable to the facilities;
            (3) analyze the management structure, distribution of 
        expenditures, and nurse staffing levels of facilities of the 
        chain in relation to resident census, staff turnover rates, and 
        tenure;
            (4) <<NOTE: Reports.>> report findings and recommendations 
        with respect to such reviews, analyses, and oversight to the 
        chain and facilities of the chain, to the Secretary, and to 
        relevant States; and
            (5) <<NOTE: Publication.>> publish the results of such 
        reviews, analyses, and oversight.

    (d) Implementation of Recommendations.--
            (1) Receipt of finding by chain. <<NOTE: Deadline.>> --Not 
        later than 10 days after receipt of a finding of an independent 
        monitor under subsection (c)(4), <<NOTE: Reports.>> a chain 
        participating in the demonstration project shall submit to the 
        independent monitor a report--
                    (A) outlining corrective actions the chain will take 
                to implement the recommendations in such report; or
                    (B) indicating that the chain will not implement 
                such recommendations, and why it will not do so.
            (2) Receipt of report by independent monitor.--Not later 
        than 10 days after receipt of a report submitted by a chain 
        under paragraph (1), an independent monitor shall finalize its 
        recommendations and submit a report to the chain and facilities 
        of the chain, the Secretary, and the State or States, as 
        appropriate, containing such final recommendations.

[[Page 124 STAT. 718]]

    (e) Cost of Appointment.--A chain shall be responsible for a portion 
of the costs associated with the appointment of independent monitors 
under the demonstration project under this 
section. <<NOTE: Payment. Procedures.>> The chain shall pay such portion 
to the Secretary (in an amount and in accordance with procedures 
established by the Secretary).

    (f) Waiver Authority.--The Secretary may waive such requirements of 
titles XVIII and XIX of the Social Security Act (42 U.S.C. 1395 et seq.; 
1396 et seq.) as may be necessary for the purpose of carrying out the 
demonstration project under this section.
    (g) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this section.
    (h) Definitions.--In this section:
            (1) Additional disclosable party.--The term ``additional 
        disclosable party'' has the meaning given such term in section 
        1124(c)(5)(A) of the Social Security Act, as added by section 
        4201(a).
            (2) Facility.--The term ``facility'' means a skilled nursing 
        facility or a nursing facility.
            (3) Nursing facility.--The term ``nursing facility'' has the 
        meaning given such term in section 1919(a) of the Social 
        Security Act (42 U.S.C. 1396r(a)).
            (4) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services, acting through the Assistant 
        Secretary for Planning and Evaluation.
            (5) Skilled nursing facility.--The term ``skilled nursing 
        facility'' has the meaning given such term in section 1819(a) of 
        the Social Security Act (42 U.S.C. 1395(a)).

    (i) Evaluation and Report.--
            (1) Evaluation.--The Secretary, in consultation with the 
        Inspector General of the Department of Health and Human 
        Services, shall evaluate the demonstration project conducted 
        under this section.
            (2) Report.--Not later than 180 days after the completion of 
        the demonstration project under this section, the Secretary 
        shall submit to Congress a report containing the results of the 
        evaluation conducted under paragraph (1), together with 
        recommendations--
                    (A) as to whether the independent monitor program 
                should be established on a permanent basis;
                    (B) if the Secretary recommends that such program be 
                so established, on appropriate procedures and mechanisms 
                for such establishment; and
                    (C) for such legislation and administrative action 
                as the Secretary determines appropriate.

SEC. 6113. NOTIFICATION OF FACILITY CLOSURE.

    (a) In General.--Section 1128I of the Social Security Act, as added 
and amended by this Act, <<NOTE: 42 USC 1320a-7j.>> is amended by adding 
at the end the following new subsection:

    ``(h) Notification of Facility Closure.--
            ``(1) In general.--Any individual who is the administrator 
        of a facility must--

[[Page 124 STAT. 719]]

                    ``(A) <<NOTE: Notification. Deadlines.>> submit to 
                the Secretary, the State long-term care ombudsman, 
                residents of the facility, and the legal representatives 
                of such residents or other responsible parties, written 
                notification of an impending closure--
                          ``(i) subject to clause (ii), not later than 
                      the date that is 60 days prior to the date of such 
                      closure; and
                          ``(ii) in the case of a facility where the 
                      Secretary terminates the facility's participation 
                      under this title, not later than the date that the 
                      Secretary determines appropriate;
                    ``(B) ensure that the facility does not admit any 
                new residents on or after the date on which such written 
                notification is submitted; and
                    ``(C) <<NOTE: Plans.>> include in the notice a plan 
                for the transfer and adequate relocation of the 
                residents of the facility by a specified date prior to 
                closure that has been approved by the State, including 
                assurances that the residents will be transferred to the 
                most appropriate facility or other setting in terms of 
                quality, services, and location, taking into 
                consideration the needs, choice, and best interests of 
                each resident.
            ``(2) Relocation.--
                    ``(A) In general.--The State shall ensure that, 
                before a facility closes, all residents of the facility 
                have been successfully relocated to another facility or 
                an alternative home and community-based setting.
                    ``(B) Continuation of payments until residents 
                relocated.-- <<NOTE: Time period.>> The Secretary may, 
                as the Secretary determines appropriate, continue to 
                make payments under this title with respect to residents 
                of a facility that has submitted a notification under 
                paragraph (1) during the period beginning on the date 
                such notification is submitted and ending on the date on 
                which the resident is successfully relocated.
            ``(3) Sanctions.--Any individual who is the administrator of 
        a facility that fails to comply with the requirements of 
        paragraph (1)--
                    ``(A) shall be subject to a civil monetary penalty 
                of up to $100,000;
                    ``(B) may be subject to exclusion from participation 
                in any Federal health care program (as defined in 
                section 1128B(f)); and
                    ``(C) shall be subject to any other penalties that 
                may be prescribed by law.
            ``(4) Procedure.-- <<NOTE: Applicability.>> The provisions 
        of section 1128A (other than subsections (a) and (b) and the 
        second sentence of subsection (f)) shall apply to a civil money 
        penalty or exclusion under paragraph (3) in the same manner as 
        such provisions apply to a penalty or proceeding under section 
        1128A(a).''.

    (b) Conforming Amendments.--Section 1819(h)(4) of the Social 
Security Act (42 U.S.C. 1395i-3(h)(4)) is amended--
            (1) in the first sentence, by striking ``the Secretary shall 
        terminate'' and inserting ``the Secretary, subject to section 
        1128I(h), shall terminate''; and
            (2) in the second sentence, by striking ``subsection 
        (c)(2)'' and inserting ``subsection (c)(2) and section 
        1128I(h)''.

[[Page 124 STAT. 720]]

    (c) <<NOTE: 42 USC 1320a-7j note.>> Effective Date.--The amendments 
made by this section shall take effect 1 year after the date of the 
enactment of this Act.

SEC. 6114. <<NOTE: 42 USC 1395i-3 note.>> NATIONAL DEMONSTRATION 
            PROJECTS ON CULTURE CHANGE AND USE OF INFORMATION TECHNOLOGY 
            IN NURSING HOMES.

    (a) In General.--The Secretary shall conduct 2 demonstration 
projects, 1 for the development of best practices in skilled nursing 
facilities and nursing facilities that are involved in the culture 
change movement (including the development of resources for facilities 
to find and access funding in order to undertake culture change) and 1 
for the development of best practices in skilled nursing facilities and 
nursing facilities for the use of information technology to improve 
resident care.
    (b) Conduct of Demonstration Projects.--
            (1) Grant award.--Under each demonstration project conducted 
        under this section, the Secretary shall award 1 or more grants 
        to facility-based settings for the development of best practices 
        described in subsection (a) with respect to the demonstration 
        project involved. Such award shall be made on a competitive 
        basis and may be allocated in 1 lump-sum payment.
            (2) Consideration of special needs of residents.--Each 
        demonstration project conducted under this section shall take 
        into consideration the special needs of residents of skilled 
        nursing facilities and nursing facilities who have cognitive 
        impairment, including dementia.

    (c) Duration and Implementation.--
            (1) Duration.--The demonstration projects shall each be 
        conducted for a period not to exceed 3 years.
            (2) Implementation.-- <<NOTE: Deadline.>> The demonstration 
        projects shall each be implemented not later than 1 year after 
        the date of the enactment of this Act.

    (d) Definitions.--In this section:
            (1) Nursing facility.--The term ``nursing facility'' has the 
        meaning given such term in section 1919(a) of the Social 
        Security Act (42 U.S.C. 1396r(a)).
            (2) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (3) Skilled nursing facility.--The term ``skilled nursing 
        facility'' has the meaning given such term in section 1819(a) of 
        the Social Security Act (42 U.S.C. 1395(a)).

    (e) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this section.
    (f) Report.-- <<NOTE: Recommenda- tions.>> Not later than 9 months 
after the completion of the demonstration project, the Secretary shall 
submit to Congress a report on such project, together with 
recommendations for such legislation and administrative action as the 
Secretary determines appropriate.

                   PART III--IMPROVING STAFF TRAINING

SEC. 6121. DEMENTIA AND ABUSE PREVENTION TRAINING.

    (a) Skilled Nursing Facilities.--
            (1) In general.--Section 1819(f)(2)(A)(i)(I) of the Social 
        Security Act (42 U.S.C. 1395i-3(f)(2)(A)(i)(I)) is amended by

[[Page 124 STAT. 721]]

        inserting ``(including, in the case of initial training and, if 
        the Secretary determines appropriate, in the case of ongoing 
        training, dementia management training, and patient abuse 
        prevention training'' before ``, (II)''.
            (2) Clarification of definition of nurse aide.--Section 
        1819(b)(5)(F) of the Social Security Act (42 U.S.C. 1395i-
        3(b)(5)(F)) is amended by adding at the end the following flush 
        sentence:
                ``Such term includes an individual who provides such 
                services through an agency or under a contract with the 
                facility.''.

    (b) Nursing Facilities.--
            (1) In general.--Section 1919(f)(2)(A)(i)(I) of the Social 
        Security Act (42 U.S.C. 1396r(f)(2)(A)(i)(I)) is amended by 
        inserting ``(including, in the case of initial training and, if 
        the Secretary determines appropriate, in the case of ongoing 
        training, dementia management training, and patient abuse 
        prevention training'' before ``, (II)''.
            (2) Clarification of definition of nurse aide.--Section 
        1919(b)(5)(F) of the Social Security Act (42 U.S.C. 
        1396r(b)(5)(F)) is amended by adding at the end the following 
        flush sentence:
                ``Such term includes an individual who provides such 
                services through an agency or under a contract with the 
                facility.''.

    (c) <<NOTE: 42 USC 1395i-3 note.>> Effective Date.--The amendments 
made by this section shall take effect 1 year after the date of the 
enactment of this Act.

Subtitle C--Nationwide Program for National and State Background Checks 
  on Direct Patient Access Employees of Long-term Care Facilities and 
                                Providers

SEC. 6201. <<NOTE: 42 USC 1320a-7l.>> NATIONWIDE PROGRAM FOR NATIONAL 
            AND STATE BACKGROUND CHECKS ON DIRECT PATIENT ACCESS 
            EMPLOYEES OF LONG-TERM CARE FACILITIES AND PROVIDERS.

    (a) In General.--The Secretary of Health and Human Services (in this 
section referred to as the ``Secretary''), shall establish a program to 
identify efficient, effective, and economical procedures for long term 
care facilities or providers to conduct background checks on prospective 
direct patient access employees on a nationwide basis (in this 
subsection, such program shall be referred to as the ``nationwide 
program''). Except for the following modifications, the Secretary shall 
carry out the nationwide program under similar terms and conditions as 
the pilot program under section 307 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (Public Law 108-173; 117 
Stat. 2257), including the prohibition on hiring abusive workers and the 
authorization of the imposition of penalties by a participating State 
under subsection (b)(3)(A) and (b)(6), respectively, of such section 
307:
            (1) Agreements.--

[[Page 124 STAT. 722]]

                    (A) Newly participating states.--The Secretary shall 
                enter into agreements with each State--
                          (i) that the Secretary has not entered into an 
                      agreement with under subsection (c)(1) of such 
                      section 307;
                          (ii) that agrees to conduct background checks 
                      under the nationwide program on a Statewide basis; 
                      and
                          (iii) that submits an application to the 
                      Secretary containing such information and at such 
                      time as the Secretary may specify.
                    (B) Certain previously participating states.--The 
                Secretary shall enter into agreements with each State--
                          (i) that the Secretary has entered into an 
                      agreement with under such subsection (c)(1), but 
                      only in the case where such agreement did not 
                      require the State to conduct background checks 
                      under the program established under subsection (a) 
                      of such section 307 on a Statewide basis;
                          (ii) that agrees to conduct background checks 
                      under the nationwide program on a Statewide basis; 
                      and
                          (iii) that submits an application to the 
                      Secretary containing such information and at such 
                      time as the Secretary may specify.
            (2) Nonapplication of selection criteria.--The selection 
        criteria required under subsection (c)(3)(B) of such section 307 
        shall not apply.
            (3) Required fingerprint check as part of criminal history 
        background check.--The procedures established under subsection 
        (b)(1) of such section 307 shall--
                    (A) require that the long-term care facility or 
                provider (or the designated agent of the long-term care 
                facility or provider) obtain State and national criminal 
                history background checks on the prospective employee 
                through such means as the Secretary determines 
                appropriate, efficient, and effective that utilize a 
                search of State-based abuse and neglect registries and 
                databases, including the abuse and neglect registries of 
                another State in the case where a prospective employee 
                previously resided in that State, State criminal history 
                records, the records of any proceedings in the State 
                that may contain disqualifying information about 
                prospective employees (such as proceedings conducted by 
                State professional licensing and disciplinary boards and 
                State Medicaid Fraud Control Units), and Federal 
                criminal history records, including a fingerprint check 
                using the Integrated Automated Fingerprint 
                Identification System of the Federal Bureau of 
                Investigation;
                    (B) require States to describe and test methods that 
                reduce duplicative fingerprinting, including providing 
                for the development of ``rap back'' capability by the 
                State such that, if a direct patient access employee of 
                a long-term care facility or provider is convicted of a 
                crime following the initial criminal history background 
                check conducted

[[Page 124 STAT. 723]]

                with respect to such employee, and the employee's 
                fingerprints match the prints on file with the State law 
                enforcement department, the department will immediately 
                inform the State and the State will immediately inform 
                the long-term care facility or provider which employs 
                the direct patient access employee of such conviction; 
                and
                    (C) require that criminal history background checks 
                conducted under the nationwide program remain valid for 
                a period of time specified by the Secretary.
            (4) State requirements.--An agreement entered into under 
        paragraph (1) shall require that a participating State--
                    (A) be responsible for monitoring compliance with 
                the requirements of the nationwide program;
                    (B) <<NOTE: Procedures.>> have procedures in place 
                to--
                          (i) conduct screening and criminal history 
                      background checks under the nationwide program in 
                      accordance with the requirements of this section;
                          (ii) monitor compliance by long-term care 
                      facilities and providers with the procedures and 
                      requirements of the nationwide program;
                          (iii) as appropriate, provide for a 
                      provisional period of employment by a long-term 
                      care facility or provider of a direct patient 
                      access employee, not to exceed 60 days, pending 
                      completion of the required criminal history 
                      background check and, in the case where the 
                      employee has appealed the results of such 
                      background check, pending completion of the 
                      appeals process, during which the employee shall 
                      be subject to direct on-site supervision (in 
                      accordance with procedures established by the 
                      State to ensure that a long-term care facility or 
                      provider furnishes such direct on-site 
                      supervision);
                          (iv) provide an independent process by which a 
                      provisional employee or an employee may appeal or 
                      dispute the accuracy of the information obtained 
                      in a background check performed under the 
                      nationwide program, including the specification of 
                      criteria for appeals for direct patient access 
                      employees found to have disqualifying information 
                      which shall include consideration of the passage 
                      of time, extenuating circumstances, demonstration 
                      of rehabilitation, and relevancy of the particular 
                      disqualifying information with respect to the 
                      current employment of the individual;
                          (v) provide for the designation of a single 
                      State agency as responsible for--
                                    (I) overseeing the coordination of 
                                any State and national criminal history 
                                background checks requested by a long-
                                term care facility or provider (or the 
                                designated agent of the long-term care 
                                facility or provider) utilizing a search 
                                of State and Federal criminal history 
                                records, including a fingerprint check 
                                of such records;
                                    (II) overseeing the design of 
                                appropriate privacy and security 
                                safeguards for use in the review of the 
                                results of any State or national 
                                criminal history background checks 
                                conducted regarding a

[[Page 124 STAT. 724]]

                                prospective direct patient access 
                                employee to determine whether the 
                                employee has any conviction for a 
                                relevant crime;
                                    (III) immediately reporting to the 
                                long-term care facility or provider that 
                                requested the criminal history 
                                background check the results of such 
                                review; and
                                    (IV) in the case of an employee with 
                                a conviction for a relevant crime that 
                                is subject to reporting under section 
                                1128E of the Social Security Act (42 
                                U.S.C. 1320a-7e), reporting the 
                                existence of such conviction to the 
                                database established under that section;
                          (vi) determine which individuals are direct 
                      patient access employees (as defined in paragraph 
                      (6)(B)) for purposes of the nationwide program;
                          (vii) as appropriate, specify offenses, 
                      including convictions for violent crimes, for 
                      purposes of the nationwide program; and
                          (viii) describe and test methods that reduce 
                      duplicative fingerprinting, including providing 
                      for the development of ``rap back'' capability 
                      such that, if a direct patient access employee of 
                      a long-term care facility or provider is convicted 
                      of a crime following the initial criminal history 
                      background check conducted with respect to such 
                      employee, and the employee's fingerprints match 
                      the prints on file with the State law enforcement 
                      department--
                                    (I) the department will immediately 
                                inform the State agency designated under 
                                clause (v) and such agency will 
                                immediately inform the facility or 
                                provider which employs the direct 
                                patient access employee of such 
                                conviction; and
                                    (II) the State will provide, or will 
                                require the facility to provide, to the 
                                employee a copy of the results of the 
                                criminal history background check 
                                conducted with respect to the employee 
                                at no charge in the case where the 
                                individual requests such a copy.
            (5) Payments.--
                    (A) Newly participating states.--
                          (i) In general.--As part of the application 
                      submitted by a State under paragraph (1)(A)(iii), 
                      the State shall guarantee, with respect to the 
                      costs to be incurred by the State in carrying out 
                      the nationwide program, that the State will make 
                      available (directly or through donations from 
                      public or private entities) a particular amount of 
                      non-Federal contributions, as a condition of 
                      receiving the Federal match under clause (ii).
                          (ii) Federal match.--The payment amount to 
                      each State that the Secretary enters into an 
                      agreement with under paragraph (1)(A) shall be 3 
                      times the amount that the State guarantees to make 
                      available under clause (i), except that in no case 
                      may the payment amount exceed $3,000,000.
                    (B) Previously participating states.--

[[Page 124 STAT. 725]]

                          (i) In general.--As part of the application 
                      submitted by a State under paragraph (1)(B)(iii), 
                      the State shall guarantee, with respect to the 
                      costs to be incurred by the State in carrying out 
                      the nationwide program, that the State will make 
                      available (directly or through donations from 
                      public or private entities) a particular amount of 
                      non-Federal contributions, as a condition of 
                      receiving the Federal match under clause (ii).
                          (ii) Federal match.--The payment amount to 
                      each State that the Secretary enters into an 
                      agreement with under paragraph (1)(B) shall be 3 
                      times the amount that the State guarantees to make 
                      available under clause (i), except that in no case 
                      may the payment amount exceed $1,500,000.
            (6) Definitions.--Under the nationwide program:
                    (A) Conviction for a relevant crime.--The term 
                ``conviction for a relevant crime'' means any Federal or 
                State criminal conviction for--
                          (i) any offense described in section 1128(a) 
                      of the Social Security Act (42 U.S.C. 1320a-7); or
                          (ii) such other types of offenses as a 
                      participating State may specify for purposes of 
                      conducting the program in such State.
                    (B) Disqualifying information.--The term 
                ``disqualifying information'' means a conviction for a 
                relevant crime or a finding of patient or resident 
                abuse.
                    (C) Finding of patient or resident abuse.--The term 
                ``finding of patient or resident abuse'' means any 
                substantiated finding by a State agency under section 
                1819(g)(1)(C) or 1919(g)(1)(C) of the Social Security 
                Act (42 U.S.C. 1395i-3(g)(1)(C), 1396r(g)(1)(C)) or a 
                Federal agency that a direct patient access employee has 
                committed--
                          (i) an act of patient or resident abuse or 
                      neglect or a misappropriation of patient or 
                      resident property; or
                          (ii) such other types of acts as a 
                      participating State may specify for purposes of 
                      conducting the program in such State.
                    (D) Direct patient access employee.--The term 
                ``direct patient access employee'' means any individual 
                who has access to a patient or resident of a long-term 
                care facility or provider through employment or through 
                a contract with such facility or provider and has duties 
                that involve (or may involve) one-on-one contact with a 
                patient or resident of the facility or provider, as 
                determined by the State for purposes of the nationwide 
                program. Such term does not include a volunteer unless 
                the volunteer has duties that are equivalent to the 
                duties of a direct patient access employee and those 
                duties involve (or may involve) one-on-one contact with 
                a patient or resident of the long-term care facility or 
                provider.
                    (E) Long-term care facility or provider.--The term 
                ``long-term care facility or provider'' means the 
                following facilities or providers which receive payment 
                for services under title XVIII or XIX of the Social 
                Security Act:

[[Page 124 STAT. 726]]

                          (i) A skilled nursing facility (as defined in 
                      section 1819(a) of the Social Security Act (42 
                      U.S.C. 1395i-3(a))).
                          (ii) A nursing facility (as defined in section 
                      1919(a) of such Act (42 U.S.C. 1396r(a))).
                          (iii) A home health agency.
                          (iv) A provider of hospice care (as defined in 
                      section 1861(dd)(1) of such Act (42 U.S.C. 
                      1395x(dd)(1))).
                          (v) A long-term care hospital (as described in 
                      section 1886(d)(1)(B)(iv) of such Act (42 U.S.C. 
                      1395ww(d)(1)(B)(iv))).
                          (vi) A provider of personal care services.
                          (vii) A provider of adult day care.
                          (viii) A residential care provider that 
                      arranges for, or directly provides, long-term care 
                      services, including an assisted living facility 
                      that provides a level of care established by the 
                      Secretary.
                          (ix) An intermediate care facility for the 
                      mentally retarded (as defined in section 1905(d) 
                      of such Act (42 U.S.C. 1396d(d))).
                          (x) Any other facility or provider of long-
                      term care services under such titles as the 
                      participating State determines appropriate.
            (7) Evaluation and report.--
                    (A) Evaluation.--
                          (i) In general.--The Inspector General of the 
                      Department of Health and Human Services shall 
                      conduct an evaluation of the nationwide program.
                          (ii) Inclusion of specific topics.--The 
                      evaluation conducted under clause (i) shall 
                      include the following:
                                    (I) A review of the various 
                                procedures implemented by participating 
                                States for long-term care facilities or 
                                providers, including staffing agencies, 
                                to conduct background checks of direct 
                                patient access employees under the 
                                nationwide program and identification of 
                                the most appropriate, efficient, and 
                                effective procedures for conducting such 
                                background checks.
                                    (II) An assessment of the costs of 
                                conducting such background checks 
                                (including start up and administrative 
                                costs).
                                    (III) A determination of the extent 
                                to which conducting such background 
                                checks leads to any unintended 
                                consequences, including a reduction in 
                                the available workforce for long-term 
                                care facilities or providers.
                                    (IV) An assessment of the impact of 
                                the nationwide program on reducing the 
                                number of incidents of neglect, abuse, 
                                and misappropriation of resident 
                                property to the extent practicable.
                                    (V) An evaluation of other aspects 
                                of the nationwide program, as determined 
                                appropriate by the Secretary.
                    (B) Report.--Not later than 180 days after the 
                completion of the nationwide program, the Inspector 
                General of the Department of Health and Human Services 
                shall

[[Page 124 STAT. 727]]

                submit a report to Congress containing the results of 
                the evaluation conducted under subparagraph (A).

    (b) Funding.--
            (1) Notification.--The Secretary of Health and Human 
        Services shall notify the Secretary of the Treasury of the 
        amount necessary to carry out the nationwide program under this 
        section for the period of fiscal years 2010 through 2012, except 
        that in no case shall such amount exceed $160,000,000.
            (2) Transfer of funds.--
                    (A) In general.--Out of any funds in the Treasury 
                not otherwise appropriated, the Secretary of the 
                Treasury shall provide for the transfer to the Secretary 
                of Health and Human Services of the amount specified as 
                necessary to carry out the nationwide program under 
                paragraph (1). Such amount shall remain available until 
                expended.
                    (B) Reservation of funds for conduct of 
                evaluation.--The Secretary may reserve not more than 
                $3,000,000 of the amount transferred under subparagraph 
                (A) to provide for the conduct of the evaluation under 
                subsection (a)(7)(A).

             Subtitle D--Patient-Centered Outcomes Research

SEC. 6301. PATIENT-CENTERED OUTCOMES RESEARCH.

    (a) In General.--Title XI of the Social Security Act (42 U.S.C. 1301 
et seq.) is amended by adding at the end the following new part:

          ``Part D--Comparative Clinical Effectiveness Research


              ``comparative clinical effectiveness research


    ``Sec. 1181.  <<NOTE: 42 USC 1320e.>> (a) Definitions.--In this 
section:
            ``(1) Board.--The term `Board' means the Board of Governors 
        established under subsection (f).
            ``(2) Comparative clinical effectiveness research; 
        research.--
                    ``(A) In general.--The terms `comparative clinical 
                effectiveness research' and `research' mean research 
                evaluating and comparing health outcomes and the 
                clinical effectiveness, risks, and benefits of 2 or more 
                medical treatments, services, and items described in 
                subparagraph (B).
                    ``(B) Medical treatments, services, and items 
                described.--The medical treatments, services, and items 
                described in this subparagraph are health care 
                interventions, protocols for treatment, care management, 
                and delivery, procedures, medical devices, diagnostic 
                tools, pharmaceuticals (including drugs and 
                biologicals), integrative health practices, and any 
                other strategies or items being used in the treatment, 
                management, and diagnosis of, or prevention of illness 
                or injury in, individuals.
            ``(3) Conflict of interest.--The term `conflict of interest' 
        means an association, including a financial or personal 
        association, that have the potential to bias or have the 
        appearance

[[Page 124 STAT. 728]]

        of biasing an individual's decisions in matters related to the 
        Institute or the conduct of activities under this section.
            ``(4) Real conflict of interest.--The term `real conflict of 
        interest' means any instance where a member of the Board, the 
        methodology committee established under subsection (d)(6), or an 
        advisory panel appointed under subsection (d)(4), or a close 
        relative of such member, has received or could receive either of 
        the following:
                    ``(A) A direct financial benefit of any amount 
                deriving from the result or findings of a study 
                conducted under this section.
                    ``(B) A financial benefit from individuals or 
                companies that own or manufacture medical treatments, 
                services, or items to be studied under this section that 
                in the aggregate exceeds $10,000 per year. For purposes 
                of the preceding sentence, a financial benefit includes 
                honoraria, fees, stock, or other financial benefit and 
                the current value of the member or close relative's 
                already existing stock holdings, in addition to any 
                direct financial benefit deriving from the results or 
                findings of a study conducted under this section.

    ``(b) Patient-Centered Outcomes Research Institute.--
            ``(1) Establishment.--There is authorized to be established 
        a nonprofit corporation, to be known as the `Patient-Centered 
        Outcomes Research Institute' (referred to in this section as the 
        `Institute') which is neither an agency nor establishment of the 
        United States Government.
            ``(2) <<NOTE: District of Columbia.>> Application of 
        provisions.--The Institute shall be subject to the provisions of 
        this section, and, to the extent consistent with this section, 
        to the District of Columbia Nonprofit Corporation Act.
            ``(3) Funding of comparative clinical effectiveness 
        research.--For fiscal year 2010 and each subsequent fiscal year, 
        amounts in the Patient-Centered Outcomes Research Trust Fund 
        (referred to in this section as the `PCORTF') under section 9511 
        of the Internal Revenue Code of 1986 shall be available, without 
        further appropriation, to the Institute to carry out this 
        section.

    ``(c) Purpose.--The purpose of the Institute is to assist patients, 
clinicians, purchasers, and policy-makers in making informed health 
decisions by advancing the quality and relevance of evidence concerning 
the manner in which diseases, disorders, and other health conditions can 
effectively and appropriately be prevented, diagnosed, treated, 
monitored, and managed through research and evidence synthesis that 
considers variations in patient subpopulations, and the dissemination of 
research findings with respect to the relative health outcomes, clinical 
effectiveness, and appropriateness of the medical treatments, services, 
and items described in subsection (a)(2)(B).
    ``(d) Duties.--
            ``(1) Identifying research priorities and establishing 
        research project agenda.--
                    ``(A) Identifying research priorities.--The 
                Institute shall identify national priorities for 
                research, taking into account factors of disease 
                incidence, prevalence, and burden in the United States 
                (with emphasis on chronic conditions), gaps in evidence 
                in terms of clinical outcomes, practice

[[Page 124 STAT. 729]]

                variations and health disparities in terms of delivery 
                and outcomes of care, the potential for new evidence to 
                improve patient health, well-being, and the quality of 
                care, the effect on national expenditures associated 
                with a health care treatment, strategy, or health 
                conditions, as well as patient needs, outcomes, and 
                preferences, the relevance to patients and clinicians in 
                making informed health decisions, and priorities in the 
                National Strategy for quality care established under 
                section 399H of the Public Health Service Act that are 
                consistent with this section.
                    ``(B) Establishing research project agenda.--The 
                Institute shall establish and update a research project 
                agenda for research to address the priorities identified 
                under subparagraph (A), taking into consideration the 
                types of research that might address each priority and 
                the relative value (determined based on the cost of 
                conducting research compared to the potential usefulness 
                of the information produced by research) associated with 
                the different types of research, and such other factors 
                as the Institute determines appropriate.
            ``(2) Carrying out research project agenda.--
                    ``(A) Research.--The Institute shall carry out the 
                research project agenda established under paragraph 
                (1)(B) in accordance with the methodological standards 
                adopted under paragraph (9) using methods, including the 
                following:
                          ``(i) Systematic reviews and assessments of 
                      existing and future research and evidence 
                      including original research conducted subsequent 
                      to the date of the enactment of this section.
                          ``(ii) Primary research, such as randomized 
                      clinical trials, molecularly informed trials, and 
                      observational studies.
                          ``(iii) Any other methodologies recommended by 
                      the methodology committee established under 
                      paragraph (6) that are adopted by the Board under 
                      paragraph (9).
                    ``(B) Contracts for the management of funding and 
                conduct of research.--
                          ``(i) Contracts.--
                                    ``(I) In general.--In accordance 
                                with the research project agenda 
                                established under paragraph (1)(B), the 
                                Institute shall enter into contracts for 
                                the management of funding and conduct of 
                                research in accordance with the 
                                following:
                                            ``(aa) Appropriate agencies 
                                        and instrumentalities of the 
                                        Federal Government.
                                            ``(bb) Appropriate academic 
                                        research, private sector 
                                        research, or study-conducting 
                                        entities.
                                    ``(II) Preference.--In entering into 
                                contracts under subclause (I), the 
                                Institute shall give preference to the 
                                Agency for Healthcare Research and 
                                Quality and the National Institutes of 
                                Health, but only if the research to be 
                                conducted or managed under such contract 
                                is authorized by the governing statutes 
                                of such Agency or Institutes.

[[Page 124 STAT. 730]]

                          ``(ii) Conditions for contracts.--A contract 
                      entered into under this subparagraph shall require 
                      that the agency, instrumentality, or other 
                      entity--
                                    ``(I) abide by the transparency and 
                                conflicts of interest requirements under 
                                subsection (h) that apply to the 
                                Institute with respect to the research 
                                managed or conducted under such 
                                contract;
                                    ``(II) comply with the 
                                methodological standards adopted under 
                                paragraph (9) with respect to such 
                                research;
                                    ``(III) consult with the expert 
                                advisory panels for clinical trials and 
                                rare disease appointed under clauses 
                                (ii) and (iii), respectively, of 
                                paragraph (4)(A);
                                    ``(IV) subject to clause (iv), 
                                permit a researcher who conducts 
                                original research under the contract for 
                                the agency, instrumentality, or other 
                                entity to have such research published 
                                in a peer-reviewed journal or other 
                                publication;
                                    ``(V) have appropriate processes in 
                                place to manage data privacy and meet 
                                ethical standards for the research;
                                    ``(VI) comply with the requirements 
                                of the Institute for making the 
                                information available to the public 
                                under paragraph (8); and
                                    ``(VII) comply with other terms and 
                                conditions determined necessary by the 
                                Institute to carry out the research 
                                agenda adopted under paragraph (2).
                          ``(iii) Coverage of copayments or 
                      coinsurance.--A contract entered into under this 
                      subparagraph may allow for the coverage of 
                      copayments or coinsurance, or allow for other 
                      appropriate measures, to the extent that such 
                      coverage or other measures are necessary to 
                      preserve the validity of a research project, such 
                      as in the case where the research project must be 
                      blinded.
                          ``(iv) Requirements for publication of 
                      research.--Any research published under clause 
                      (ii)(IV) shall be within the bounds of and 
                      entirely consistent with the evidence and findings 
                      produced under the contract with the Institute 
                      under this subparagraph. If the Institute 
                      determines that those requirements are not met, 
                      the Institute shall not enter into another 
                      contract with the agency, instrumentality, or 
                      entity which managed or conducted such research 
                      for a period determined appropriate by the 
                      Institute (but not less than 5 years).
                    ``(C) Review and update of evidence.--The Institute 
                shall review and update evidence on a periodic basis as 
                appropriate.
                    ``(D) Taking into account potential differences.--
                Research shall be designed, as appropriate, to take into 
                account the potential for differences in the 
                effectiveness of health care treatments, services, and 
                items as used with various subpopulations, such as 
                racial and ethnic minorities, women, age, and groups of 
                individuals with different comorbidities, genetic and 
                molecular sub-types,

[[Page 124 STAT. 731]]

                or quality of life preferences and include members of 
                such subpopulations as subjects in the research as 
                feasible and appropriate.
                    ``(E) Differences in treatment modalities.--Research 
                shall be designed, as appropriate, to take into account 
                different characteristics of treatment modalities that 
                may affect research outcomes, such as the phase of the 
                treatment modality in the innovation cycle and the 
                impact of the skill of the operator of the treatment 
                modality.
            ``(3) Data collection.--
                    ``(A) In general.--The Secretary shall, with 
                appropriate safeguards for privacy, make available to 
                the Institute such data collected by the Centers for 
                Medicare & Medicaid Services under the programs under 
                titles XVIII, XIX, and XXI, as well as provide access to 
                the data networks developed under section 937(f) of the 
                Public Health Service Act, as the Institute and its 
                contractors may require to carry out this section. The 
                Institute may also request and obtain data from Federal, 
                State, or private entities, including data from clinical 
                databases and registries.
                    ``(B) Use of data.--The Institute shall only use 
                data provided to the Institute under subparagraph (A) in 
                accordance with laws and regulations governing the 
                release and use of such data, including applicable 
                confidentiality and privacy standards.
            ``(4) Appointing expert advisory panels.--
                    ``(A) Appointment.--
                          ``(i) In general.--The Institute may appoint 
                      permanent or ad hoc expert advisory panels as 
                      determined appropriate to assist in identifying 
                      research priorities and establishing the research 
                      project agenda under paragraph (1) and for other 
                      purposes.
                          ``(ii) Expert advisory panels for clinical 
                      trials.--The Institute shall appoint expert 
                      advisory panels in carrying out randomized 
                      clinical trials under the research project agenda 
                      under paragraph (2)(A)(ii). Such expert advisory 
                      panels shall advise the Institute and the agency, 
                      instrumentality, or entity conducting the research 
                      on the research question involved and the research 
                      design or protocol, including important patient 
                      subgroups and other parameters of the research. 
                      Such panels shall be available as a resource for 
                      technical questions that may arise during the 
                      conduct of such research.
                          ``(iii) Expert advisory panel for rare 
                      disease.--In the case of a research study for rare 
                      disease, the Institute shall appoint an expert 
                      advisory panel for purposes of assisting in the 
                      design of the research study and determining the 
                      relative value and feasibility of conducting the 
                      research study.
                    ``(B) Composition.--An expert advisory panel 
                appointed under subparagraph (A) shall include 
                representatives of practicing and research clinicians, 
                patients, and experts in scientific and health services 
                research, health services delivery, and evidence-based 
                medicine who have experience in the relevant topic, and 
                as appropriate, experts

[[Page 124 STAT. 732]]

                in integrative health and primary prevention strategies. 
                The Institute may include a technical expert of each 
                manufacturer or each medical technology that is included 
                under the relevant topic, project, or category for which 
                the panel is established.
            ``(5) Supporting patient and consumer representatives.--The 
        Institute shall provide support and resources to help patient 
        and consumer representatives effectively participate on the 
        Board and expert advisory panels appointed by the Institute 
        under paragraph (4).
            ``(6) Establishing methodology committee.--
                    ``(A) In general.--The Institute shall establish a 
                standing methodology committee to carry out the 
                functions described in subparagraph (C).
                    ``(B) Appointment and composition.--The methodology 
                committee established under subparagraph (A) shall be 
                composed of not more than 15 members appointed by the 
                Comptroller General of the United States. Members 
                appointed to the methodology committee shall be experts 
                in their scientific field, such as health services 
                research, clinical research, comparative clinical 
                effectiveness research, biostatistics, genomics, and 
                research methodologies. Stakeholders with such expertise 
                may be appointed to the methodology committee. In 
                addition to the members appointed under the first 
                sentence, the Directors of the National Institutes of 
                Health and the Agency for Healthcare Research and 
                Quality (or their designees) shall each be included as 
                members of the methodology committee.
                    ``(C) Functions.-- <<NOTE: Deadline.>> Subject to 
                subparagraph (D), the methodology committee shall work 
                to develop and improve the science and methods of 
                comparative clinical effectiveness research by, not 
                later than 18 months after the establishment of the 
                Institute, directly or through subcontract, developing 
                and periodically updating the following:
                          ``(i) Methodological standards for research. 
                      Such methodological standards shall provide 
                      specific criteria for internal validity, 
                      generalizability, feasibility, and timeliness of 
                      research and for health outcomes measures, risk 
                      adjustment, and other relevant aspects of research 
                      and assessment with respect to the design of 
                      research. Any methodological standards developed 
                      and updated under this subclause shall be 
                      scientifically based and include methods by which 
                      new information, data, or advances in technology 
                      are considered and incorporated into ongoing 
                      research projects by the Institute, as 
                      appropriate. The process for developing and 
                      updating such standards shall include input from 
                      relevant experts, stakeholders, and 
                      decisionmakers, and shall provide opportunities 
                      for public comment. Such standards shall also 
                      include methods by which patient subpopulations 
                      can be accounted for and evaluated in different 
                      types of research. As appropriate, such standards 
                      shall build on existing work on methodological 
                      standards for defined categories of health 
                      interventions and for each of the major categories 
                      of

[[Page 124 STAT. 733]]

                      comparative clinical effectiveness research 
                      methods (determined as of the date of enactment of 
                      the Patient Protection and Affordable Care Act).
                          ``(ii) A translation table that is designed to 
                      provide guidance and act as a reference for the 
                      Board to determine research methods that are most 
                      likely to address each specific research question.
                    ``(D) Consultation and conduct of examinations.--The 
                methodology committee may consult and contract with the 
                Institute of Medicine of the National Academies and 
                academic, nonprofit, or other private and governmental 
                entities with relevant expertise to carry out activities 
                described in subparagraph (C) and may consult with 
                relevant stakeholders to carry out such activities.
                    ``(E) Reports.--The methodology committee shall 
                submit reports to the Board on the committee's 
                performance of the functions described in subparagraph 
                (C). <<NOTE: Recommenda- tions.>> Reports shall contain 
                recommendations for the Institute to adopt 
                methodological standards developed and updated by the 
                methodology committee as well as other actions deemed 
                necessary to comply with such methodological standards.
            ``(7) Providing for a peer-review process for primary 
        research.--
                    ``(A) In general.--The Institute shall ensure that 
                there is a process for peer review of primary research 
                described in subparagraph (A)(ii) of paragraph (2) that 
                is conducted under such paragraph. Under such process--
                          ``(i) evidence from such primary research 
                      shall be reviewed to assess scientific integrity 
                      and adherence to methodological standards adopted 
                      under paragraph (9); and
                          ``(ii) <<NOTE: Lists. Public information.>> a 
                      list of the names of individuals contributing to 
                      any peer-review process during the preceding year 
                      or years shall be made public and included in 
                      annual reports in accordance with paragraph 
                      (10)(D).
                    ``(B) Composition.--Such peer-review process shall 
                be designed in a manner so as to avoid bias and 
                conflicts of interest on the part of the reviewers and 
                shall be composed of experts in the scientific field 
                relevant to the research under review.
                    ``(C) Use of existing processes.--
                          ``(i) Processes of another entity.--In the 
                      case where the Institute enters into a contract or 
                      other agreement with another entity for the 
                      conduct or management of research under this 
                      section, the Institute may utilize the peer-review 
                      process of such entity if such process meets the 
                      requirements under subparagraphs (A) and (B).
                          ``(ii) Processes of appropriate medical 
                      journals.--The Institute may utilize the peer-
                      review process of appropriate medical journals if 
                      such process meets the requirements under 
                      subparagraphs (A) and (B).
            ``(8) Release of research findings.--
                    ``(A) In general.-- <<NOTE: Deadline.>> The 
                Institute shall, not later than 90 days after the 
                conduct or receipt of research findings under this part, 
                make such research findings available

[[Page 124 STAT. 734]]

                to clinicians, patients, and the general public. The 
                Institute shall ensure that the research findings--
                          ``(i) convey the findings of research in a 
                      manner that is comprehensible and useful to 
                      patients and providers in making health care 
                      decisions;
                          ``(ii) fully convey findings and discuss 
                      considerations specific to certain subpopulations, 
                      risk factors, and comorbidities, as appropriate;
                          ``(iii) include limitations of the research 
                      and what further research may be needed as 
                      appropriate;
                          ``(iv) not be construed as mandates for 
                      practice guidelines, coverage recommendations, 
                      payment, or policy recommendations; and
                          ``(v) not include any data which would violate 
                      the privacy of research participants or any 
                      confidentiality agreements made with respect to 
                      the use of data under this section.
                    ``(B) Definition of research findings.--In this 
                paragraph, the term `research findings' means the 
                results of a study or assessment.
            ``(9) Adoption.--Subject to subsection (h)(1), the Institute 
        shall adopt the national priorities identified under paragraph 
        (1)(A), the research project agenda established under paragraph 
        (1)(B), the methodological standards developed and updated by 
        the methodology committee under paragraph (6)(C)(i), and any 
        peer-review process provided under paragraph (7) by majority 
        vote. In the case where the Institute does not adopt such 
        processes in accordance with the preceding sentence, the 
        processes shall be referred to the appropriate staff or entity 
        within the Institute (or, in the case of the methodological 
        standards, the methodology committee) for further review.
            ``(10) <<NOTE: Public information.>> Annual reports.--The 
        Institute shall submit an annual report to Congress and the 
        President, and shall make the annual report available to the 
        public. Such report shall contain--
                    ``(A) a description of the activities conducted 
                under this section, research priorities identified under 
                paragraph (1)(A) and methodological standards developed 
                and updated by the methodology committee under paragraph 
                (6)(C)(i) that are adopted under paragraph (9) during 
                the preceding year;
                    ``(B) the research project agenda and budget of the 
                Institute for the following year;
                    ``(C) any administrative activities conducted by the 
                Institute during the preceding year;
                    ``(D) the names of individuals contributing to any 
                peer-review process under paragraph (7), without 
                identifying them with a particular research project; and
                    ``(E) any other relevant information (including 
                information on the membership of the Board, expert 
                advisory panels, methodology committee, and the 
                executive staff of the Institute, any conflicts of 
                interest with respect to these individuals, and any 
                bylaws adopted by the Board during the preceding year).

    ``(e) Administration.--
            ``(1) In general.--Subject to paragraph (2), the Board shall 
        carry out the duties of the Institute.

[[Page 124 STAT. 735]]

            ``(2) Nondelegable duties.--The activities described in 
        subsections (d)(1) and (d)(9) are nondelegable.

    ``(f) Board of Governors.--
            ``(1) <<NOTE: Establishment.>> In general.--The Institute 
        shall have a Board of Governors, which shall consist of the 
        following members:
                    ``(A) The Director of Agency for Healthcare Research 
                and Quality (or the Director's designee).
                    ``(B) The Director of the National Institutes of 
                Health (or the Director's designee).
                    ``(C) <<NOTE: Deadline.>> Seventeen members 
                appointed, not later than 6 months after the date of 
                enactment of this section, by the Comptroller General of 
                the United States as follows:
                          ``(i) 3 members representing patients and 
                      health care consumers.
                          ``(ii) 5 members representing physicians and 
                      providers, including at least 1 surgeon, nurse, 
                      State-licensed integrative health care 
                      practitioner, and representative of a hospital.
                          ``(iii) 3 members representing private payers, 
                      of whom at least 1 member shall represent health 
                      insurance issuers and at least 1 member shall 
                      represent employers who self-insure employee 
                      benefits.
                          ``(iv) 3 members representing pharmaceutical, 
                      device, and diagnostic manufacturers or 
                      developers.
                          ``(v) 1 member representing quality 
                      improvement or independent health service 
                      researchers.
                          ``(vi) 2 members representing the Federal 
                      Government or the States, including at least 1 
                      member representing a Federal health program or 
                      agency.
            ``(2) Qualifications.--The Board shall represent a broad 
        range of perspectives and collectively have scientific expertise 
        in clinical health sciences research, including epidemiology, 
        decisions sciences, health economics, and statistics. In 
        appointing the Board, the Comptroller General of the United 
        States shall consider and disclose any conflicts of interest in 
        accordance with subsection (h)(4)(B). Members of the Board shall 
        be recused from relevant Institute activities in the case where 
        the member (or an immediate family member of such member) has a 
        real conflict of interest directly related to the research 
        project or the matter that could affect or be affected by such 
        participation.
            ``(3) Terms; vacancies.--A member of the Board shall be 
        appointed for a term of 6 years, except with respect to the 
        members first appointed, whose terms of appointment shall be 
        staggered evenly over 2-year increments. No individual shall be 
        appointed to the Board for more than 2 terms. Vacancies shall be 
        filled in the same manner as the original appointment was made.
            ``(4) Chairperson and vice-chairperson.-- 
        <<NOTE: Designation.>> The Comptroller General of the United 
        States shall designate a Chairperson and Vice Chairperson of the 
        Board from among the members of the Board. Such members shall 
        serve as Chairperson or Vice Chairperson for a period of 3 
        years.
            ``(5) Compensation.--Each member of the Board who is not an 
        officer or employee of the Federal Government shall be entitled 
        to compensation (equivalent to the rate provided for level IV of 
        the Executive Schedule under section 5315 of

[[Page 124 STAT. 736]]

        title 5, United States Code) and expenses incurred while 
        performing the duties of the Board. An officer or employee of 
        the Federal government who is a member of the Board shall be 
        exempt from compensation.
            ``(6) Director and staff; experts and consultants.--The 
        Board may employ and fix the compensation of an Executive 
        Director and such other personnel as may be necessary to carry 
        out the duties of the Institute and may seek such assistance and 
        support of, or contract with, experts and consultants that may 
        be necessary for the performance of the duties of the Institute.
            ``(7) Meetings and hearings.--The Board shall meet and hold 
        hearings at the call of the Chairperson or a majority of its 
        members. Meetings not solely concerning matters of personnel 
        shall be advertised at least 7 days in advance and open to the 
        public. A majority of the Board members shall constitute a 
        quorum, but a lesser number of members may meet and hold 
        hearings.

    ``(g) Financial and Governmental Oversight.--
            ``(1) Contract for audit.--The Institute shall provide for 
        the conduct of financial audits of the Institute on an annual 
        basis by a private entity with expertise in conducting financial 
        audits.
            ``(2) Review and annual reports.--
                    ``(A) Review.--The Comptroller General of the United 
                States shall review the following:
                          ``(i) Not less frequently than on an annual 
                      basis, the financial audits conducted under 
                      paragraph (1).
                          ``(ii) Not less frequently than every 5 years, 
                      the processes established by the Institute, 
                      including the research priorities and the conduct 
                      of research projects, in order to determine 
                      whether information produced by such research 
                      projects is objective and credible, is produced in 
                      a manner consistent with the requirements under 
                      this section, and is developed through a 
                      transparent process.
                          ``(iii) Not less frequently than every 5 
                      years, the dissemination and training activities 
                      and data networks established under section 937 of 
                      the Public Health Service Act, including the 
                      methods and products used to disseminate research, 
                      the types of training conducted and supported, and 
                      the types and functions of the data networks 
                      established, in order to determine whether the 
                      activities and data are produced in a manner 
                      consistent with the requirements under such 
                      section.
                          ``(iv) Not less frequently than every 5 years, 
                      the overall effectiveness of activities conducted 
                      under this section and the dissemination, 
                      training, and capacity building activities 
                      conducted under section 937 of the Public Health 
                      Service Act. Such review shall include an analysis 
                      of the extent to which research findings are used 
                      by health care decision-makers, the effect of the 
                      dissemination of such findings on reducing 
                      practice variation and disparities in health care, 
                      and the effect of the research conducted and 
                      disseminated on

[[Page 124 STAT. 737]]

                      innovation and the health care economy of the 
                      United States.
                          ``(v) Not later than 8 years after the date of 
                      enactment of this section, the adequacy and use of 
                      the funding for the Institute and the activities 
                      conducted under section 937 of the Public Health 
                      Service Act, including a determination as to 
                      whether, based on the utilization of research 
                      findings by public and private payers, funding 
                      sources for the Patient-Centered Outcomes Research 
                      Trust Fund under section 9511 of the Internal 
                      Revenue Code of 1986 are appropriate and whether 
                      such sources of funding should be continued or 
                      adjusted.
                    ``(B) Annual reports.-- <<NOTE: Recommenda- 
                tions.>> Not later than April 1 of each year, the 
                Comptroller General of the United States shall submit to 
                Congress a report containing the results of the review 
                conducted under subparagraph (A) with respect to the 
                preceding year (or years, if applicable), together with 
                recommendations for such legislation and administrative 
                action as the Comptroller General determines 
                appropriate.

    ``(h) Ensuring Transparency, Credibility, and Access.-- 
<<NOTE: Procedures.>> The Institute shall establish procedures to ensure 
that the following requirements for ensuring transparency, credibility, 
and access are met:
            ``(1) Public comment periods.--The Institute shall provide 
        for a public comment period of not less than 45 days and not 
        more than 60 days prior to the adoption under subsection (d)(9) 
        of the national priorities identified under subsection 
        (d)(1)(A), the research project agenda established under 
        subsection (d)(1)(B), the methodological standards developed and 
        updated by the methodology committee under subsection 
        (d)(6)(C)(i), and the peer-review process provided under 
        paragraph (7), and after the release of draft findings with 
        respect to systematic reviews of existing research and evidence.
            ``(2) Additional forums.--The Institute shall support forums 
        to increase public awareness and obtain and incorporate public 
        input and feedback through media (such as an Internet website) 
        on research priorities, research findings, and other duties, 
        activities, or processes the Institute determines appropriate.
            ``(3) Public availability.-- <<NOTE: Web posting.>> The 
        Institute shall make available to the public and disclose 
        through the official public Internet website of the Institute 
        the following:
                    ``(A) Information contained in research findings as 
                specified in subsection (d)(9).
                    ``(B) The process and methods for the conduct of 
                research, including the identity of the entity and the 
                investigators conducing such research and any conflicts 
                of interests of such parties, any direct or indirect 
                links the entity has to industry, and research 
                protocols, including measures taken, methods of research 
                and analysis, research results, and such other 
                information the Institute determines appropriate) 
                concurrent with the release of research findings.
                    ``(C) <<NOTE: Notice.>> Notice of public comment 
                periods under paragraph (1), including deadlines for 
                public comments.

[[Page 124 STAT. 738]]

                    ``(D) Subsequent comments received during each of 
                the public comment periods.
                    ``(E) In accordance with applicable laws and 
                processes and as the Institute determines appropriate, 
                proceedings of the Institute.
            ``(4) Disclosure of conflicts of interest.--
                    ``(A) In general.--A conflict of interest shall be 
                disclosed in the following manner:
                          ``(i) By the Institute in appointing members 
                      to an expert advisory panel under subsection 
                      (d)(4), in selecting individuals to contribute to 
                      any peer-review process under subsection (d)(7), 
                      and for employment as executive staff of the 
                      Institute.
                          ``(ii) By the Comptroller General in 
                      appointing members of the methodology committee 
                      under subsection (d)(6);
                          ``(iii) By the Institute in the annual report 
                      under subsection (d)(10), except that, in the case 
                      of individuals contributing to any such peer 
                      review process, such description shall be in a 
                      manner such that those individuals cannot be 
                      identified with a particular research project.
                    ``(B) Manner of disclosure.-- <<NOTE: Web 
                posting.>> Conflicts of interest shall be disclosed as 
                described in subparagraph (A) as soon as practicable on 
                the Internet web site of the Institute and of the 
                Government Accountability Office. The information 
                disclosed under the preceding sentence shall include the 
                type, nature, and magnitude of the interests of the 
                individual involved, except to the extent that the 
                individual recuses himself or herself from participating 
                in the consideration of or any other activity with 
                respect to the study as to which the potential conflict 
                exists.

    ``(i) Rules.--The Institute, its Board or staff, shall be prohibited 
from accepting gifts, bequeaths, or donations of services or property. 
In addition, the Institute shall be prohibited from establishing a 
corporation or generating revenues from activities other than as 
provided under this section.
    ``(j) Rules of Construction.--
            ``(1) Coverage.--Nothing in this section shall be 
        construed--
                    ``(A) to permit the Institute to mandate coverage, 
                reimbursement, or other policies for any public or 
                private payer; or
                    ``(B) as preventing the Secretary from covering the 
                routine costs of clinical care received by an individual 
                entitled to, or enrolled for, benefits under title 
                XVIII, XIX, or XXI in the case where such individual is 
                participating in a clinical trial and such costs would 
                otherwise be covered under such title with respect to 
                the beneficiary.''.

    (b) Dissemination and Building Capacity for Research.--Title IX of 
the Public Health Service Act (42 U.S.C. 299 et seq.), as amended by 
section 3606, is further amended by inserting after section 936 the 
following:

``SEC. 937. <<NOTE: 42 USC 299b-37.>> DISSEMINATION AND BUILDING 
            CAPACITY FOR RESEARCH.

    ``(a) In General.--

[[Page 124 STAT. 739]]

            ``(1) Dissemination.--The Office of Communication and 
        Knowledge Transfer (referred to in this section as the `Office') 
        at the Agency for Healthcare Research and Quality (or any other 
        relevant office designated by Agency for Healthcare Research and 
        Quality), in consultation with the National Institutes of 
        Health, shall broadly disseminate the research findings that are 
        published by the Patient Centered Outcomes Research Institute 
        established under section 1181(b) of the Social Security Act 
        (referred to in this section as the `Institute') and other 
        government-funded research relevant to comparative clinical 
        effectiveness research. The Office shall create informational 
        tools that organize and disseminate research findings for 
        physicians, health care providers, patients, payers, and policy 
        makers. <<NOTE: Public information.>> The Office shall also 
        develop a publicly available resource database that collects and 
        contains government-funded evidence and research from public, 
        private, not-for profit, and academic sources.
            ``(2) Requirements.--The Office shall provide for the 
        dissemination of the Institute's research findings and 
        government-funded research relevant to comparative clinical 
        effectiveness research to physicians, health care providers, 
        patients, vendors of health information technology focused on 
        clinical decision support, appropriate professional 
        associations, and Federal and private health plans. Materials, 
        forums, and media used to disseminate the findings, 
        informational tools, and resource databases shall--
                    ``(A) include a description of considerations for 
                specific subpopulations, the research methodology, and 
                the limitations of the research, and the names of the 
                entities, agencies, instrumentalities, and individuals 
                who conducted any research which was published by the 
                Institute; and
                    ``(B) not be construed as mandates, guidelines, or 
                recommendations for payment, coverage, or treatment.

    ``(b) Incorporation of Research Findings.--The Office, in 
consultation with relevant medical and clinical associations, shall 
assist users of health information technology focused on clinical 
decision support to promote the timely incorporation of research 
findings disseminated under subsection (a) into clinical practices and 
to promote the ease of use of such incorporation.
    ``(c) Feedback.--The Office shall establish a process to receive 
feedback from physicians, health care providers, patients, and vendors 
of health information technology focused on clinical decision support, 
appropriate professional associations, and Federal and private health 
plans about the value of the information disseminated and the assistance 
provided under this section.
    ``(d) Rule of Construction.--Nothing in this section shall preclude 
the Institute from making its research findings publicly available as 
required under section 1181(d)(8) of the Social Security Act.
    ``(e) Training of Researchers.--The Agency for Health Care Research 
and Quality, in consultation with the National Institutes of Health, 
shall build capacity for comparative clinical effectiveness research by 
establishing a grant program that provides for the training of 
researchers in the methods used to conduct such research, including 
systematic reviews of existing research and primary research such as 
clinical trials. At a minimum, such

[[Page 124 STAT. 740]]

training shall be in methods that meet the methodological standards 
adopted under section 1181(d)(9) of the Social Security Act.
    ``(f) Building Data for Research.--The Secretary shall provide for 
the coordination of relevant Federal health programs to build data 
capacity for comparative clinical effectiveness research, including the 
development and use of clinical registries and health outcomes research 
data networks, in order to develop and maintain a comprehensive, 
interoperable data network to collect, link, and analyze data on 
outcomes and effectiveness from multiple sources, including electronic 
health records.
    ``(g) Authority To Contract With the Institute.--Agencies and 
instrumentalities of the Federal Government may enter into agreements 
with the Institute, and accept and retain funds, for the conduct and 
support of research described in this part, provided that the research 
to be conducted or supported under such agreements is authorized under 
the governing statutes of such agencies and instrumentalities.''.
    (c) In General.--Part D of title XI of the Social Security Act, as 
added by subsection (a), is amended by adding at the end the following 
new section:


  ``limitations on certain uses of comparative clinical effectiveness 
                                research


    ``Sec. 1182.  <<NOTE: 42 USC 1320e-1.>> (a) The Secretary may only 
use evidence and findings from research conducted under section 1181 to 
make a determination regarding coverage under title XVIII if such use is 
through an iterative and transparent process which includes public 
comment and considers the effect on subpopulations.

    ``(b) Nothing in section 1181 shall be construed as--
            ``(1) superceding or modifying the coverage of items or 
        services under title XVIII that the Secretary determines are 
        reasonable and necessary under section 1862(l)(1); or
            ``(2) authorizing the Secretary to deny coverage of items or 
        services under such title solely on the basis of comparative 
        clinical effectiveness research.

    ``(c)(1) The Secretary shall not use evidence or findings from 
comparative clinical effectiveness research conducted under section 1181 
in determining coverage, reimbursement, or incentive programs under 
title XVIII in a manner that treats extending the life of an elderly, 
disabled, or terminally ill individual as of lower value than extending 
the life of an individual who is younger, nondisabled, or not terminally 
ill.
    ``(2) Paragraph (1) shall not be construed as preventing the 
Secretary from using evidence or findings from such comparative clinical 
effectiveness research in determining coverage, reimbursement, or 
incentive programs under title XVIII based upon a comparison of the 
difference in the effectiveness of alternative treatments in extending 
an individual's life due to the individual's age, disability, or 
terminal illness.
    ``(d)(1) The Secretary shall not use evidence or findings from 
comparative clinical effectiveness research conducted under section 1181 
in determining coverage, reimbursement, or incentive programs under 
title XVIII in a manner that precludes, or with the intent to 
discourage, an individual from choosing a health care treatment based on 
how the individual values the tradeoff between extending the length of 
their life and the risk of disability.
    ``(2)(A) Paragraph (1) shall not be construed to--

[[Page 124 STAT. 741]]

            ``(i) limit the application of differential copayments under 
        title XVIII based on factors such as cost or type of service; or
            ``(ii) prevent the Secretary from using evidence or findings 
        from such comparative clinical effectiveness research in 
        determining coverage, reimbursement, or incentive programs under 
        such title based upon a comparison of the difference in the 
        effectiveness of alternative health care treatments in extending 
        an individual's life due to that individual's age, disability, 
        or terminal illness.

    ``(3) Nothing in the provisions of, or amendments made by the 
Patient Protection and Affordable Care Act, shall be construed to limit 
comparative clinical effectiveness research or any other research, 
evaluation, or dissemination of information concerning the likelihood 
that a health care treatment will result in disability.
    ``(e) The Patient-Centered Outcomes Research Institute established 
under section 1181(b)(1) shall not develop or employ a dollars-per-
quality adjusted life year (or similar measure that discounts the value 
of a life because of an individual's disability) as a threshold to 
establish what type of health care is cost effective or recommended. The 
Secretary shall not utilize such an adjusted life year (or such a 
similar measure) as a threshold to determine coverage, reimbursement, or 
incentive programs under title XVIII.''.
    (d) In General.--Part D of title XI of the Social Security Act, as 
added by subsection (a) and amended by subsection (c), is amended by 
adding at the end the following new section:


 ``trust fund transfers to patient-centered outcomes research trust fund


    ``Sec. 1183.  <<NOTE: 42 USC 1320e-2.>> (a) In General.--The 
Secretary shall provide for the transfer, from the Federal Hospital 
Insurance Trust Fund under section 1817 and the Federal Supplementary 
Medical Insurance Trust Fund under section 1841, in proportion (as 
estimated by the Secretary) to the total expenditures during such fiscal 
year that are made under title XVIII from the respective trust fund, to 
the Patient-Centered Outcomes Research Trust Fund (referred to in this 
section as the `PCORTF') under section 9511 of the Internal Revenue Code 
of 1986, of the following:
            ``(1) For fiscal year 2013, an amount equal to $1 multiplied 
        by the average number of individuals entitled to benefits under 
        part A, or enrolled under part B, of title XVIII during such 
        fiscal year.
            ``(2) For each of fiscal years 2014, 2015, 2016, 2017, 2018, 
        and 2019, an amount equal to $2 multiplied by the average number 
        of individuals entitled to benefits under part A, or enrolled 
        under part B, of title XVIII during such fiscal year.

    ``(b) Adjustments for Increases in Health Care Spending.--In the 
case of any fiscal year beginning after September 30, 2014, the dollar 
amount in effect under subsection (a)(2) for such fiscal year shall be 
equal to the sum of such dollar amount for the previous fiscal year 
(determined after the application of this subsection), plus an amount 
equal to the product of--
            ``(1) such dollar amount for the previous fiscal year, 
        multiplied by
            ``(2) the percentage increase in the projected per capita 
        amount of National Health Expenditures, as most recently 
        published by the Secretary before the beginning of the fiscal 
        year.''.

[[Page 124 STAT. 742]]

    (e) Patient-Centered Outcomes Research Trust Fund; Financing for 
Trust Fund.--
            (1) Establishment of trust fund.--
                    (A) In general.--Subchapter A of chapter 98 of the 
                Internal Revenue Code of 1986 (relating to establishment 
                of trust funds) is amended by adding at the end the 
                following new section:

``SEC. 9511. <<NOTE: 26 USC 9511.>> PATIENT-CENTERED OUTCOMES RESEARCH 
            TRUST FUND.

    ``(a) Creation of Trust Fund.--There is established in the Treasury 
of the United States a trust fund to be known as the `Patient-Centered 
Outcomes Research Trust Fund' (hereafter in this section referred to as 
the `PCORTF'), consisting of such amounts as may be appropriated or 
credited to such Trust Fund as provided in this section and section 
9602(b).
    ``(b) Transfers to Fund.--
            ``(1) Appropriation.--There are hereby appropriated to the 
        Trust Fund the following:
                    ``(A) For fiscal year 2010, $10,000,000.
                    ``(B) For fiscal year 2011, $50,000,000.
                    ``(C) For fiscal year 2012, $150,000,000.
                    ``(D) For fiscal year 2013--
                          ``(i) an amount equivalent to the net revenues 
                      received in the Treasury from the fees imposed 
                      under subchapter B of chapter 34 (relating to fees 
                      on health insurance and self-insured plans) for 
                      such fiscal year; and
                          ``(ii) $150,000,000.
                    ``(E) For each of fiscal years 2014, 2015, 2016, 
                2017, 2018, and 2019--
                          ``(i) an amount equivalent to the net revenues 
                      received in the Treasury from the fees imposed 
                      under subchapter B of chapter 34 (relating to fees 
                      on health insurance and self-insured plans) for 
                      such fiscal year; and
                          ``(ii) $150,000,000.
                The amounts appropriated under subparagraphs (A), (B), 
                (C), (D)(ii), and (E)(ii) shall be transferred from the 
                general fund of the Treasury, from funds not otherwise 
                appropriated.
            ``(2) Trust fund transfers.--In addition to the amounts 
        appropriated under paragraph (1), there shall be credited to the 
        PCORTF the amounts transferred under section 1183 of the Social 
        Security Act.
            ``(3) Limitation on transfers to pcortf.--No amount may be 
        appropriated or transferred to the PCORTF on and after the date 
        of any expenditure from the PCORTF which is not an expenditure 
        permitted under this section. The determination of whether an 
        expenditure is so permitted shall be made without regard to--
                    ``(A) any provision of law which is not contained or 
                referenced in this chapter or in a revenue Act, and
                    ``(B) whether such provision of law is a 
                subsequently enacted provision or directly or indirectly 
                seeks to waive the application of this paragraph.

    ``(c) Trustee.--The Secretary of the Treasury shall be a trustee of 
the PCORTF.

[[Page 124 STAT. 743]]

    ``(d) Expenditures From Fund.--
            ``(1) Amounts available to the patient-centered outcomes 
        research institute.--Subject to paragraph (2), amounts in the 
        PCORTF are available, without further appropriation, to the 
        Patient-Centered Outcomes Research Institute established under 
        section 1181(b) of the Social Security Act for carrying out part 
        D of title XI of the Social Security Act (as in effect on the 
        date of enactment of such Act).
            ``(2) Transfer of funds.--
                    ``(A) In general.--The trustee of the PCORTF shall 
                provide for the transfer from the PCORTF of 20 percent 
                of the amounts appropriated or credited to the PCORTF 
                for each of fiscal years 2011 through 2019 to the 
                Secretary of Health and Human Services to carry out 
                section 937 of the Public Health Service Act.
                    ``(B) Availability.--Amounts transferred under 
                subparagraph (A) shall remain available until expended.
                    ``(C) Requirements.--Of the amounts transferred 
                under subparagraph (A) with respect to a fiscal year, 
                the Secretary of Health and Human Services shall 
                distribute--
                          ``(i) 80 percent to the Office of 
                      Communication and Knowledge Transfer of the Agency 
                      for Healthcare Research and Quality (or any other 
                      relevant office designated by Agency for 
                      Healthcare Research and Quality) to carry out the 
                      activities described in section 937 of the Public 
                      Health Service Act; and
                          ``(ii) 20 percent to the Secretary to carry 
                      out the activities described in such section 937.

    ``(e) Net Revenues.-- <<NOTE: Definition.>> For purposes of this 
section, the term `net revenues' means the amount estimated by the 
Secretary of the Treasury based on the excess of--
            ``(1) the fees received in the Treasury under subchapter B 
        of chapter 34, over
            ``(2) the decrease in the tax imposed by chapter 1 resulting 
        from the fees imposed by such subchapter.

    ``(f) Termination.--No amounts shall be available for expenditure 
from the PCORTF after September 30, 2019, and any amounts in such Trust 
Fund after such date shall be transferred to the general fund of the 
Treasury.''.
                    (B) Clerical amendment.--The table of sections for 
                subchapter A of chapter 98 of such Code is amended by 
                adding at the end the following new item:

``Sec. 9511. Patient-centered outcomes research trust fund.''.

            (2) Financing for fund from fees on insured and self-insured 
        health plans.--
                    (A) General rule.--Chapter 34 of the Internal 
                Revenue Code of 1986 is amended by adding at the end the 
                following new subchapter:

          ``Subchapter B--Insured and Self-Insured Health Plans

``Sec. 4375. Health insurance.
``Sec. 4376. Self-insured health plans.
``Sec. 4377. Definitions and special rules.

``SEC. 4375. <<NOTE: 26 USC 4375.>> HEALTH INSURANCE.

    ``(a) Imposition of Fee.--There is hereby imposed on each specified 
health insurance policy for each policy year ending after

[[Page 124 STAT. 744]]

September 30, 2012, a fee equal to the product of $2 ($1 in the case of 
policy years ending during fiscal year 2013) multiplied by the average 
number of lives covered under the policy.
    ``(b) Liability for Fee.--The fee imposed by subsection (a) shall be 
paid by the issuer of the policy.
    ``(c) Specified Health Insurance Policy.--For purposes of this 
section:
            ``(1) In general.-- <<NOTE: Definition.>> Except as 
        otherwise provided in this section, the term `specified health 
        insurance policy' means any accident or health insurance policy 
        (including a policy under a group health plan) issued with 
        respect to individuals residing in the United States.
            ``(2) Exemption for certain policies.--The term `specified 
        health insurance policy' does not include any insurance if 
        substantially all of its coverage is of excepted benefits 
        described in section 9832(c).
            ``(3) Treatment of prepaid health coverage arrangements.--
                    ``(A) In general.--In the case of any arrangement 
                described in subparagraph (B), such arrangement shall be 
                treated as a specified health insurance policy, and the 
                person referred to in such subparagraph shall be treated 
                as the issuer.
                    ``(B) Description of arrangements.--An arrangement 
                is described in this subparagraph if under such 
                arrangement fixed payments or premiums are received as 
                consideration for any person's agreement to provide or 
                arrange for the provision of accident or health coverage 
                to residents of the United States, regardless of how 
                such coverage is provided or arranged to be provided.

    ``(d) Adjustments for Increases in Health Care Spending.--In the 
case of any policy year ending in any fiscal year beginning after 
September 30, 2014, the dollar amount in effect under subsection (a) for 
such policy year shall be equal to the sum of such dollar amount for 
policy years ending in the previous fiscal year (determined after the 
application of this subsection), plus an amount equal to the product 
of--
            ``(1) such dollar amount for policy years ending in the 
        previous fiscal year, multiplied by
            ``(2) the percentage increase in the projected per capita 
        amount of National Health Expenditures, as most recently 
        published by the Secretary before the beginning of the fiscal 
        year.

    ``(e) Termination.--This section shall not apply to policy years 
ending after September 30, 2019.

``SEC. 4376. <<NOTE: 26 USC 4376.>> SELF-INSURED HEALTH PLANS.

    ``(a) Imposition of Fee.--In the case of any applicable self-insured 
health plan for each plan year ending after September 30, 2012, there is 
hereby imposed a fee equal to $2 ($1 in the case of plan years ending 
during fiscal year 2013) multiplied by the average number of lives 
covered under the plan.
    ``(b) Liability for Fee.--
            ``(1) In general.--The fee imposed by subsection (a) shall 
        be paid by the plan sponsor.
            ``(2) Plan sponsor.-- <<NOTE: Definition.>> For purposes of 
        paragraph (1) the term `plan sponsor' means--

[[Page 124 STAT. 745]]

                    ``(A) the employer in the case of a plan established 
                or maintained by a single employer,
                    ``(B) the employee organization in the case of a 
                plan established or maintained by an employee 
                organization,
                    ``(C) in the case of--
                          ``(i) a plan established or maintained by 2 or 
                      more employers or jointly by 1 or more employers 
                      and 1 or more employee organizations,
                          ``(ii) a multiple employer welfare 
                      arrangement, or
                          ``(iii) a voluntary employees' beneficiary 
                      association described in section 501(c)(9), the 
                      association, committee, joint board of trustees, 
                      or other similar group of representatives of the 
                      parties who establish or maintain the plan, or
                    ``(D) the cooperative or association described in 
                subsection (c)(2)(F) in the case of a plan established 
                or maintained by such a cooperative or association.

    ``(c) Applicable Self-insured Health Plan.-- 
<<NOTE: Definition.>> For purposes of this section, the term `applicable 
self-insured health plan' means any plan for providing accident or 
health coverage if--
            ``(1) any portion of such coverage is provided other than 
        through an insurance policy, and
            ``(2) such plan is established or maintained--
                    ``(A) by 1 or more employers for the benefit of 
                their employees or former employees,
                    ``(B) by 1 or more employee organizations for the 
                benefit of their members or former members,
                    ``(C) jointly by 1 or more employers and 1 or more 
                employee organizations for the benefit of employees or 
                former employees,
                    ``(D) by a voluntary employees' beneficiary 
                association described in section 501(c)(9),
                    ``(E) by any organization described in section 
                501(c)(6), or
                    ``(F) in the case of a plan not described in the 
                preceding subparagraphs, by a multiple employer welfare 
                arrangement (as defined in section 3(40) of Employee 
                Retirement Income Security Act of 1974), a rural 
                electric cooperative (as defined in section 3(40)(B)(iv) 
                of such Act), or a rural telephone cooperative 
                association (as defined in section 3(40)(B)(v) of such 
                Act).

    ``(d) Adjustments for Increases in Health Care Spending.--In the 
case of any plan year ending in any fiscal year beginning after 
September 30, 2014, the dollar amount in effect under subsection (a) for 
such plan year shall be equal to the sum of such dollar amount for plan 
years ending in the previous fiscal year (determined after the 
application of this subsection), plus an amount equal to the product 
of--
            ``(1) such dollar amount for plan years ending in the 
        previous fiscal year, multiplied by
            ``(2) the percentage increase in the projected per capita 
        amount of National Health Expenditures, as most recently 
        published by the Secretary before the beginning of the fiscal 
        year.

    ``(e) Termination.--This section shall not apply to plan years 
ending after September 30, 2019.

[[Page 124 STAT. 746]]

``SEC. 4377. <<NOTE: 26 USC 4377.>> DEFINITIONS AND SPECIAL RULES.

    ``(a) Definitions.--For purposes of this subchapter--
            ``(1) Accident and health coverage.--The term `accident and 
        health coverage' means any coverage which, if provided by an 
        insurance policy, would cause such policy to be a specified 
        health insurance policy (as defined in section 4375(c)).
            ``(2) Insurance policy.--The term `insurance policy' means 
        any policy or other instrument whereby a contract of insurance 
        is issued, renewed, or extended.
            ``(3) United states.--The term `United States' includes any 
        possession of the United States.

    ``(b) Treatment of Governmental Entities.--
            ``(1) In general.--For purposes of this subchapter--
                    ``(A) the term `person' includes any governmental 
                entity, and
                    ``(B) notwithstanding any other law or rule of law, 
                governmental entities shall not be exempt from the fees 
                imposed by this subchapter except as provided in 
                paragraph (2).
            ``(2) Treatment of exempt governmental programs.--In the 
        case of an exempt governmental program, no fee shall be imposed 
        under section 4375 or section 4376 on any covered life under 
        such program.
            ``(3) Exempt governmental program defined.--For purposes of 
        this subchapter, the term `exempt governmental program' means--
                    ``(A) any insurance program established under title 
                XVIII of the Social Security Act,
                    ``(B) the medical assistance program established by 
                title XIX or XXI of the Social Security Act,
                    ``(C) any program established by Federal law for 
                providing medical care (other than through insurance 
                policies) to individuals (or the spouses and dependents 
                thereof) by reason of such individuals being members of 
                the Armed Forces of the United States or veterans, and
                    ``(D) any program established by Federal law for 
                providing medical care (other than through insurance 
                policies) to members of Indian tribes (as defined in 
                section 4(d) of the Indian Health Care Improvement Act).

    ``(c) Treatment as Tax.--For purposes of subtitle F, the fees 
imposed by this subchapter shall be treated as if they were taxes.
    ``(d) No Cover Over to Possessions.--Notwithstanding any other 
provision of law, no amount collected under this subchapter shall be 
covered over to any possession of the United States.''.
                    (B) Clerical amendments.--
                          (i) Chapter 34 of such Code is amended by 
                      striking the chapter heading and inserting the 
                      following:

[[Page 124 STAT. 747]]

            ``CHAPTER 34--TAXES ON CERTAIN INSURANCE POLICIES

           ``subchapter a. policies issued by foreign insurers

          ``subchapter b. insured and self-insured health plans

         ``Subchapter A--Policies Issued By Foreign Insurers''.

                          (ii) The table of chapters for subtitle D of 
                      such Code is amended by striking the item relating 
                      to chapter 34 and inserting the following new 
                      item:

          ``Chapter 34--Taxes on Certain Insurance Policies''.

    (f) Tax-exempt Status of the Patient-centered Outcomes Research 
Institute.--Subsection 501(l) of the Internal Revenue Code of 
1986 <<NOTE: 26 USC 501.>> is amended by adding at the end the following 
new paragraph:
            ``(4) The Patient-Centered Outcomes Research Institute 
        established under section 1181(b) of the Social Security Act.''.

SEC. 6302. <<NOTE: 42 USC 2996-8 note.>> FEDERAL COORDINATING COUNCIL 
            FOR COMPARATIVE EFFECTIVENESS RESEARCH.

     <<NOTE: Termination date.>> Notwithstanding any other provision of 
law, the Federal Coordinating Council for Comparative Effectiveness 
Research established under section 804 of Division A of the American 
Recovery and Reinvestment Act of 2009 (42 U.S.C. 299b-8), including the 
requirement under subsection (e)(2) of such section, shall terminate on 
the date of enactment of this Act.

  Subtitle E--Medicare, Medicaid, and CHIP Program Integrity Provisions

SEC. 6401. PROVIDER SCREENING AND OTHER ENROLLMENT REQUIREMENTS UNDER 
            MEDICARE, MEDICAID, AND CHIP.

    (a) Medicare.--Section 1866(j) of the Social Security Act (42 U.S.C. 
1395cc(j)) is amended--
            (1) in paragraph (1)(A), by adding at the end the following: 
        ``Such process shall include screening of providers and 
        suppliers in accordance with paragraph (2), a provisional period 
        of enhanced oversight in accordance with paragraph (3), 
        disclosure requirements in accordance with paragraph (4), the 
        imposition of temporary enrollment moratoria in accordance with 
        paragraph (5), and the establishment of compliance programs in 
        accordance with paragraph (6).'';
            (2) by redesignating paragraph (2) as paragraph (7); and
            (3) by inserting after paragraph (1) the following:
            ``(2) Provider screening.--
                    ``(A) Procedures.-- <<NOTE: Deadline.>> Not later 
                than 180 days after the date of enactment of this 
                paragraph, the Secretary, in consultation with the 
                Inspector General of the Department of Health and Human 
                Services, shall establish procedures under which 
                screening is conducted with respect to providers of 
                medical or other items or services and suppliers under 
                the program under this title, the Medicaid program under 
                title XIX, and the CHIP program under title XXI.

[[Page 124 STAT. 748]]

                    ``(B) Level of screening.-- 
                <<NOTE: Determination.>> The Secretary shall determine 
                the level of screening conducted under this paragraph 
                according to the risk of fraud, waste, and abuse, as 
                determined by the Secretary, with respect to the 
                category of provider of medical or other items or 
                services or supplier. Such screening--
                          ``(i) shall include a licensure check, which 
                      may include such checks across States; and
                          ``(ii) may, as the Secretary determines 
                      appropriate based on the risk of fraud, waste, and 
                      abuse described in the preceding sentence, 
                      include--
                                    ``(I) a criminal background check;
                                    ``(II) fingerprinting;
                                    ``(III) unscheduled and unannounced 
                                site visits, including preenrollment 
                                site visits;
                                    ``(IV) database checks (including 
                                such checks across States); and
                                    ``(V) such other screening as the 
                                Secretary determines appropriate.
                    ``(C) Application fees.--
                          ``(i) Individual providers.--Except as 
                      provided in clause (iii), the Secretary shall 
                      impose a fee on each individual provider of 
                      medical or other items or services or supplier 
                      (such as a physician, physician assistant, nurse 
                      practitioner, or clinical nurse specialist) with 
                      respect to which screening is conducted under this 
                      paragraph in an amount equal to--
                                    ``(I) for 2010, $200; and
                                    ``(II) for 2011 and each subsequent 
                                year, the amount determined under this 
                                clause for the preceding year, adjusted 
                                by the percentage change in the consumer 
                                price index for all urban consumers (all 
                                items; United States city average) for 
                                the 12-month period ending with June of 
                                the previous year.
                          ``(ii) Institutional providers.--Except as 
                      provided in clause (iii), the Secretary shall 
                      impose a fee on each institutional provider of 
                      medical or other items or services or supplier 
                      (such as a hospital or skilled nursing facility) 
                      with respect to which screening is conducted under 
                      this paragraph in an amount equal to--
                                    ``(I) for 2010, $500; and
                                    ``(II) for 2011 and each subsequent 
                                year, the amount determined under this 
                                clause for the preceding year, adjusted 
                                by the percentage change in the consumer 
                                price index for all urban consumers (all 
                                items; United States city average) for 
                                the 12-month period ending with June of 
                                the previous year.
                          ``(iii) Hardship exception; waiver for certain 
                      medicaid providers.-- <<NOTE: Determination.>> The 
                      Secretary may, on a case-by-case basis, exempt a 
                      provider of medical or other items or services or 
                      supplier from the imposition of an application fee 
                      under this subparagraph if the Secretary 
                      determines that the imposition of the application 
                      fee would result in a hardship. The Secretary may

[[Page 124 STAT. 749]]

                      waive the application fee under this subparagraph 
                      for providers enrolled in a State Medicaid program 
                      for whom the State demonstrates that imposition of 
                      the fee would impede beneficiary access to care.
                          ``(iv) Use of funds.--Amounts collected as a 
                      result of the imposition of a fee under this 
                      subparagraph shall be used by the Secretary for 
                      program integrity efforts, including to cover the 
                      costs of conducting screening under this paragraph 
                      and to carry out this subsection and section 
                      1128J.
                    ``(D) Application and enforcement.--
                          ``(i) New providers of services and 
                      suppliers.--The screening under this paragraph 
                      shall apply, in the case of a provider of medical 
                      or other items or services or supplier who is not 
                      enrolled in the program under this title, title 
                      XIX , or title XXI as of the date of enactment of 
                      this paragraph, on or after the date that is 1 
                      year after such date of enactment.
                          ``(ii) Current providers of services and 
                      suppliers.--The screening under this paragraph 
                      shall apply, in the case of a provider of medical 
                      or other items or services or supplier who is 
                      enrolled in the program under this title, title 
                      XIX, or title XXI as of such date of enactment, on 
                      or after the date that is 2 years after such date 
                      of enactment.
                          ``(iii) Revalidation of enrollment.-- 
                      <<NOTE: Effective date.>> Effective beginning on 
                      the date that is 180 days after such date of 
                      enactment, the screening under this paragraph 
                      shall apply with respect to the revalidation of 
                      enrollment of a provider of medical or other items 
                      or services or supplier in the program under this 
                      title, title XIX, or title XXI.
                          ``(iv) Limitation on enrollment and 
                      revalidation of enrollment.--In no case may a 
                      provider of medical or other items or services or 
                      supplier who has not been screened under this 
                      paragraph be initially enrolled or reenrolled in 
                      the program under this title, title XIX, or title 
                      XXI on or after the date that is 3 years after 
                      such date of enactment.
                    ``(E) Expedited rulemaking.--The Secretary may 
                promulgate an interim final rule to carry out this 
                paragraph.
            ``(3) Provisional period of enhanced oversight for new 
        providers of services and suppliers.--
                    ``(A) In general.-- <<NOTE: Procedures.>> The 
                Secretary shall establish procedures to provide for a 
                provisional period of not less than 30 days and not more 
                than 1 year during which new providers of medical or 
                other items or services and suppliers, as the Secretary 
                determines appropriate, including categories of 
                providers or suppliers, would be subject to enhanced 
                oversight, such as prepayment review and payment caps, 
                under the program under this title, the Medicaid program 
                under title XIX. and the CHIP program under title XXI.
                    ``(B) Implementation.--The Secretary may establish 
                by program instruction or otherwise the procedures under 
                this paragraph.

[[Page 124 STAT. 750]]

            ``(4) Increased disclosure requirements.--
                    ``(A) Disclosure.--A provider of medical or other 
                items or services or supplier who submits an application 
                for enrollment or revalidation of enrollment in the 
                program under this title, title XIX, or title XXI on or 
                after the date that is 1 year after the date of 
                enactment of this paragraph shall disclose (in a form 
                and manner and at such time as determined by the 
                Secretary) any current or previous affiliation (directly 
                or indirectly) with a provider of medical or other items 
                or services or supplier that has uncollected debt, has 
                been or is subject to a payment suspension under a 
                Federal health care program (as defined in section 
                1128B(f)), has been excluded from participation under 
                the program under this title, the Medicaid program under 
                title XIX, or the CHIP program under title XXI, or has 
                had its billing privileges denied or revoked.
                    ``(B) Authority to deny enrollment.-- 
                <<NOTE: Determination.>> If the Secretary determines 
                that such previous affiliation poses an undue risk of 
                fraud, waste, or abuse, the Secretary may deny such 
                application. Such a denial shall be subject to appeal in 
                accordance with paragraph (7).
            ``(5) Authority to adjust payments of providers of services 
        and suppliers with the same tax identification number for past-
        due obligations.--
                    ``(A) In general.--Notwithstanding any other 
                provision of this title, in the case of an applicable 
                provider of services or supplier, the Secretary may make 
                any necessary adjustments to payments to the applicable 
                provider of services or supplier under the program under 
                this title in order to satisfy any past-due obligations 
                described in subparagraph (B)(ii) of an obligated 
                provider of services or supplier.
                    ``(B) Definitions.--In this paragraph:
                          ``(i) In general.--The term `applicable 
                      provider of services or supplier' means a provider 
                      of services or supplier that has the same taxpayer 
                      identification number assigned under section 6109 
                      of the Internal Revenue Code of 1986 as is 
                      assigned to the obligated provider of services or 
                      supplier under such section, regardless of whether 
                      the applicable provider of services or supplier is 
                      assigned a different billing number or national 
                      provider identification number under the program 
                      under this title than is assigned to the obligated 
                      provider of services or supplier.
                          ``(ii) Obligated provider of services or 
                      supplier.--The term `obligated provider of 
                      services or supplier' means a provider of services 
                      or supplier that owes a past-due obligation under 
                      the program under this title (as determined by the 
                      Secretary).
            ``(6) Temporary moratorium on enrollment of new providers.--
                    ``(A) In general.-- <<NOTE: Determination.>> The 
                Secretary may impose a temporary moratorium on the 
                enrollment of new providers of services and suppliers, 
                including categories of providers of services and 
                suppliers, in the program under this title, under the 
                Medicaid program under title XIX, or under

[[Page 124 STAT. 751]]

                the CHIP program under title XXI if the Secretary 
                determines such moratorium is necessary to prevent or 
                combat fraud, waste, or abuse under either such program.
                    ``(B) Limitation on review.--There shall be no 
                judicial review under section 1869, section 1878, or 
                otherwise, of a temporary moratorium imposed under 
                subparagraph (A).
            ``(7) Compliance programs.--
                    ``(A) In general.--On or after the date of 
                implementation determined by the Secretary under 
                subparagraph (C), a provider of medical or other items 
                or services or supplier within a particular industry 
                sector or category shall, as a condition of enrollment 
                in the program under this title, title XIX, or title 
                XXI, establish a compliance program that contains the 
                core elements established under subparagraph (B) with 
                respect to that provider or supplier and industry or 
                category.
                    ``(B) Establishment of core elements.--The 
                Secretary, in consultation with the Inspector General of 
                the Department of Health and Human Services, shall 
                establish core elements for a compliance program under 
                subparagraph (A) for providers or suppliers within a 
                particular industry or category.
                    ``(C) Timeline for implementation.-- 
                <<NOTE: Determination.>> The Secretary shall determine 
                the timeline for the establishment of the core elements 
                under subparagraph (B) and the date of the 
                implementation of subparagraph (A) for providers or 
                suppliers within a particular industry or category. The 
                Secretary shall, in determining such date of 
                implementation, consider the extent to which the 
                adoption of compliance programs by a provider of medical 
                or other items or services or supplier is widespread in 
                a particular industry sector or with respect to a 
                particular provider or supplier category.''.

    (b) Medicaid.--
            (1) State plan amendment.--Section 1902(a) of the Social 
        Security Act (42 U.S.C. 1396a(a)), as amended by section 
        4302(b), is amended--
                    (A) in subsection (a)--
                          (i) by striking ``and'' at the end of 
                      paragraph (75);
                          (ii) by striking the period at the end of 
                      paragraph (76) and inserting a semicolon; and
                          (iii) by inserting after paragraph (76) the 
                      following:
            ``(77) provide that the State shall comply with provider and 
        supplier screening, oversight, and reporting requirements in 
        accordance with subsection (ii);''; and
                    (B) by adding at the end the following:

    ``(ii) Provider and Supplier Screening, Oversight, and Reporting 
Requirements.--For purposes of subsection (a)(77), the requirements of 
this subsection are the following:
            ``(1) Screening.--The State complies with the process for 
        screening providers and suppliers under this title, as 
        established by the Secretary under section 1886(j)(2).
            ``(2) Provisional period of enhanced oversight for new 
        providers and suppliers.--The State complies with procedures to 
        provide for a provisional period of enhanced oversight for new 
        providers and suppliers under this title, as established by the 
        Secretary under section 1886(j)(3).

[[Page 124 STAT. 752]]

            ``(3) Disclosure requirements.--The State requires providers 
        and suppliers under the State plan or under a waiver of the plan 
        to comply with the disclosure requirements established by the 
        Secretary under section 1886(j)(4).
            ``(4) Temporary moratorium on enrollment of new providers or 
        suppliers.--
                    ``(A) Temporary moratorium imposed by the 
                secretary.--
                          ``(i) In general.--Subject to clause (ii), the 
                      State complies with any temporary moratorium on 
                      the enrollment of new providers or suppliers 
                      imposed by the Secretary under section 1886(j)(6).
                          ``(ii) Exception.-- <<NOTE: Determination.>> A 
                      State shall not be required to comply with a 
                      temporary moratorium described in clause (i) if 
                      the State determines that the imposition of such 
                      temporary moratorium would adversely impact 
                      beneficiaries' access to medical assistance.
                    ``(B) Moratorium on enrollment of providers and 
                suppliers.-- <<NOTE: Determination.>> At the option of 
                the State, the State imposes, for purposes of entering 
                into participation agreements with providers or 
                suppliers under the State plan or under a waiver of the 
                plan, periods of enrollment moratoria, or numerical caps 
                or other limits, for providers or suppliers identified 
                by the Secretary as being at high-risk for fraud, waste, 
                or abuse as necessary to combat fraud, waste, or abuse, 
                but only if the State determines that the imposition of 
                any such period, cap, or other limits would not 
                adversely impact beneficiaries' access to medical 
                assistance.
            ``(5) Compliance programs.--The State requires providers and 
        suppliers under the State plan or under a waiver of the plan to 
        establish, in accordance with the requirements of section 
        1866(j)(7), a compliance program that contains the core elements 
        established under subparagraph (B) of that section 1866(j)(7) 
        for providers or suppliers within a particular industry or 
        category.
            ``(6) Reporting of adverse provider actions.--The State 
        complies with the national system for reporting criminal and 
        civil convictions, sanctions, negative licensure actions, and 
        other adverse provider actions to the Secretary, through the 
        Administrator of the Centers for Medicare & Medicaid Services, 
        in accordance with regulations of the Secretary.
            ``(7) Enrollment and npi of ordering or referring 
        providers.--The State requires--
                    ``(A) all ordering or referring physicians or other 
                professionals to be enrolled under the State plan or 
                under a waiver of the plan as a participating provider; 
                and
                    ``(B) the national provider identifier of any 
                ordering or referring physician or other professional to 
                be specified on any claim for payment that is based on 
                an order or referral of the physician or other 
                professional.
            ``(8) Other state oversight.--Nothing in this subsection 
        shall be interpreted to preclude or limit the ability of a State 
        to engage in provider and supplier screening or enhanced 
        provider and supplier oversight activities beyond those required 
        by the Secretary.''.
            (2) <<NOTE: 42 USC 1395cc note.>> Disclosure of medicare 
        terminated providers and suppliers to states.--The Administrator 
        of the Centers for

[[Page 124 STAT. 753]]

        Medicare & Medicaid Services shall establish a process for 
        making available to the each State agency with responsibility 
        for administering a State Medicaid plan (or a waiver of such 
        plan) under title XIX of the Social Security Act or a child 
        health plan under title XXI the name, national provider 
        identifier, and other identifying information for any provider 
        of medical or other items or services or supplier under the 
        Medicare program under title XVIII or under the CHIP program 
        under title XXI that is terminated from participation under that 
        program within 30 days of the termination (and, with respect to 
        all such providers or suppliers who are terminated from the 
        Medicare program on the date of enactment of this Act, within 90 
        days of such date).
            (3) Conforming amendment.--Section 1902(a)(23) of the Social 
        Security Act (42 U.S.C. 1396a), is amended by inserting before 
        the semicolon at the end the following: ``or by a provider or 
        supplier to which a moratorium under subsection (ii)(4) is 
        applied during the period of such moratorium''.

    (c) CHIP.--Section 2107(e)(1) of the Social Security Act (42 U.S.C. 
1397gg(e)(1)), as amended by section 2101(d), is amended--
            (1) by redesignating subparagraphs (D) through (M) as 
        subparagraphs (E) through (N), respectively; and
            (2) by inserting after subparagraph (C), the following:
                    ``(D) Subsections (a)(77) and (ii) of section 1902 
                (relating to provider and supplier screening, oversight, 
                and reporting requirements).''.

SEC. 6402. ENHANCED MEDICARE AND MEDICAID PROGRAM INTEGRITY PROVISIONS.

    (a) In General.--Part A of title XI of the Social Security Act (42 
U.S.C. 1301 et seq.), as amended by sections 6002, 6004, and 6102, is 
amended by inserting after section 1128I the following new section:

``SEC. 1128J. <<NOTE: 42 USC 1320a-7k.>> MEDICARE AND MEDICAID PROGRAM 
            INTEGRITY PROVISIONS.

    ``(a) Data Matching.--
            ``(1) Integrated data repository.--
                    ``(A) Inclusion of certain data.--
                          ``(i) In general.--The Integrated Data 
                      Repository of the Centers for Medicare & Medicaid 
                      Services shall include, at a minimum, claims and 
                      payment data from the following:
                                    ``(I) The programs under titles 
                                XVIII and XIX (including parts A, B, C, 
                                and D of title XVIII).
                                    ``(II) The program under title XXI.
                                    ``(III) Health-related programs 
                                administered by the Secretary of 
                                Veterans Affairs.
                                    ``(IV) Health-related programs 
                                administered by the Secretary of 
                                Defense.
                                    ``(V) The program of old-age, 
                                survivors, and disability insurance 
                                benefits established under title II.
                                    ``(VI) The Indian Health Service and 
                                the Contract Health Service program.
                          ``(ii) Priority for inclusion of certain 
                      data.--Inclusion of the data described in 
                      subclause (I) of such clause in the Integrated 
                      Data Repository shall be a

[[Page 124 STAT. 754]]

                      priority. Data described in subclauses (II) 
                      through (VI) of such clause shall be included in 
                      the Integrated Data Repository as appropriate.
                    ``(B) Data sharing and matching.--
                          ``(i) In general.-- <<NOTE: Contracts.>> The 
                      Secretary shall enter into agreements with the 
                      individuals described in clause (ii) under which 
                      such individuals share and match data in the 
                      system of records of the respective agencies of 
                      such individuals with data in the system of 
                      records of the Department of Health and Human 
                      Services for the purpose of identifying potential 
                      fraud, waste, and abuse under the programs under 
                      titles XVIII and XIX.
                          ``(ii) Individuals described.--The following 
                      individuals are described in this clause:
                                    ``(I) The Commissioner of Social 
                                Security.
                                    ``(II) The Secretary of Veterans 
                                Affairs.
                                    ``(III) The Secretary of Defense.
                                    ``(IV) The Director of the Indian 
                                Health Service.
                          ``(iii) Definition of system of records.--For 
                      purposes of this paragraph, the term `system of 
                      records' has the meaning given such term in 
                      section 552a(a)(5) of title 5, United States Code.
            ``(2) Access to claims and payment databases.--For purposes 
        of conducting law enforcement and oversight activities and to 
        the extent consistent with applicable information, privacy, 
        security, and disclosure laws, including the regulations 
        promulgated under the Health Insurance Portability and 
        Accountability Act of 1996 and section 552a of title 5, United 
        States Code, and subject to any information systems security 
        requirements under such laws or otherwise required by the 
        Secretary, the Inspector General of the Department of Health and 
        Human Services and the Attorney General shall have access to 
        claims and payment data of the Department of Health and Human 
        Services and its contractors related to titles XVIII, XIX, and 
        XXI.

    ``(b) OIG Authority To Obtain Information.--
            ``(1) In general.--Notwithstanding and in addition to any 
        other provision of law, the Inspector General of the Department 
        of Health and Human Services may, for purposes of protecting the 
        integrity of the programs under titles XVIII and XIX, obtain 
        information from any individual (including a beneficiary 
        provided all applicable privacy protections are followed) or 
        entity that--
                    ``(A) is a provider of medical or other items or 
                services, supplier, grant recipient, contractor, or 
                subcontractor; or
                    ``(B) directly or indirectly provides, orders, 
                manufactures, distributes, arranges for, prescribes, 
                supplies, or receives medical or other items or services 
                payable by any Federal health care program (as defined 
                in section 1128B(f)) regardless of how the item or 
                service is paid for, or to whom such payment is made.
            ``(2) Inclusion of certain information.--Information which 
        the Inspector General may obtain under paragraph (1) includes 
        any supporting documentation necessary to validate claims for 
        payment or payments under title XVIII or XIX,

[[Page 124 STAT. 755]]

        including a prescribing physician's medical records for an 
        individual who is prescribed an item or service which is covered 
        under part B of title XVIII, a covered part D drug (as defined 
        in section 1860D-2(e)) for which payment is made under an MA-PD 
        plan under part C of such title, or a prescription drug plan 
        under part D of such title, and any records necessary for 
        evaluation of the economy, efficiency, and effectiveness of the 
        programs under titles XVIII and XIX.

    ``(c) Administrative Remedy for Knowing Participation by Beneficiary 
in Health Care Fraud Scheme.--
            ``(1) In general.-- <<NOTE: Penalty.>> In addition to any 
        other applicable remedies, if an applicable individual has 
        knowingly participated in a Federal health care fraud offense or 
        a conspiracy to commit a Federal health care fraud offense, the 
        Secretary shall impose an appropriate administrative penalty 
        commensurate with the offense or conspiracy.
            ``(2) Applicable individual.-- <<NOTE: Definition.>> For 
        purposes of paragraph (1), the term `applicable individual' 
        means an individual--
                    ``(A) entitled to, or enrolled for, benefits under 
                part A of title XVIII or enrolled under part B of such 
                title;
                    ``(B) eligible for medical assistance under a State 
                plan under title XIX or under a waiver of such plan; or
                    ``(C) eligible for child health assistance under a 
                child health plan under title XXI.

    ``(d) Reporting and Returning of Overpayments.--
            ``(1) In general.--If a person has received an overpayment, 
        the person shall--
                    ``(A) report and return the overpayment to the 
                Secretary, the State, an intermediary, a carrier, or a 
                contractor, as appropriate, at the correct address; and
                    ``(B) <<NOTE: Notification.>> notify the Secretary, 
                State, intermediary, carrier, or contractor to whom the 
                overpayment was returned in writing of the reason for 
                the overpayment.
            ``(2) Deadline for reporting and returning overpayments.--An 
        overpayment must be reported and returned under paragraph (1) by 
        the later of--
                    ``(A) the date which is 60 days after the date on 
                which the overpayment was identified; or
                    ``(B) the date any corresponding cost report is due, 
                if applicable.
            ``(3) Enforcement.--Any overpayment retained by a person 
        after the deadline for reporting and returning the overpayment 
        under paragraph (2) is an obligation (as defined in section 
        3729(b)(3) of title 31, United States Code) for purposes of 
        section 3729 of such title.
            ``(4) Definitions.--In this subsection:
                    ``(A) Knowing and knowingly.--The terms `knowing' 
                and `knowingly' have the meaning given those terms in 
                section 3729(b) of title 31, United States Code.
                    ``(B) Overpayment.--The term ``overpayment'' means 
                any funds that a person receives or retains under title 
                XVIII or XIX to which the person, after applicable 
                reconciliation, is not entitled under such title.
                    ``(C) Person.--
                          ``(i) In general.--The term `person' means a 
                      provider of services, supplier, medicaid managed 
                      care organization (as defined in section 
                      1903(m)(1)(A)),

[[Page 124 STAT. 756]]

                      Medicare Advantage organization (as defined in 
                      section 1859(a)(1)), or PDP sponsor (as defined in 
                      section 1860D-41(a)(13)).
                          ``(ii) Exclusion.--Such term does not include 
                      a beneficiary.

    ``(e) Inclusion of National Provider Identifier on All Applications 
and Claims.-- <<NOTE: Regulations. Deadline.>> The Secretary shall 
promulgate a regulation that requires, not later than January 1, 2011, 
all providers of medical or other items or services and suppliers under 
the programs under titles XVIII and XIX that qualify for a national 
provider identifier to include their national provider identifier on all 
applications to enroll in such programs and on all claims for payment 
submitted under such programs.''.

    (b) Access to Data.--
            (1) Medicare part d.--Section 1860D-15(f)(2) of the Social 
        Security Act (42 U.S.C. 1395w-116(f)(2)) <<NOTE: 42 USC 1395w-
        115.>> is amended by striking ``may be used by'' and all that 
        follows through the period at the end and inserting ``may be 
        used--
                    ``(A) by officers, employees, and contractors of the 
                Department of Health and Human Services for the purposes 
                of, and to the extent necessary in--
                          ``(i) carrying out this section; and
                          ``(ii) conducting oversight, evaluation, and 
                      enforcement under this title; and
                    ``(B) by the Attorney General and the Comptroller 
                General of the United States for the purposes of, and to 
                the extent necessary in, carrying out health oversight 
                activities.''.
            (2) Data matching.--Section 552a(a)(8)(B) of title 5, United 
        States Code, is amended--
                    (A) in clause (vii), by striking ``or'' at the end;
                    (B) in clause (viii), by inserting ``or'' after the 
                semicolon; and
                    (C) by adding at the end the following new clause:
                          ``(ix) matches performed by the Secretary of 
                      Health and Human Services or the Inspector General 
                      of the Department of Health and Human Services 
                      with respect to potential fraud, waste, and abuse, 
                      including matches of a system of records with non-
                      Federal records;''.
            (3) Matching agreements with the commissioner of social 
        security.--Section 205(r) of the Social Security Act (42 U.S.C. 
        405(r)) is amended by adding at the end the following new 
        paragraph:
            ``(9)(A) The Commissioner of Social Security shall, upon the 
        request of the Secretary or the Inspector General of the 
        Department of Health and Human Services--
                    ``(i) <<NOTE: Contracts.>> enter into an agreement 
                with the Secretary or such Inspector General for the 
                purpose of matching data in the system of records of the 
                Social Security Administration and the system of records 
                of the Department of Health and Human Services; and
                    ``(ii) include in such agreement safeguards to 
                assure the maintenance of the confidentiality of any 
                information disclosed.

[[Page 124 STAT. 757]]

            ``(B) For purposes of this paragraph, the term `system of 
        records' has the meaning given such term in section 552a(a)(5) 
        of title 5, United States Code.''.

    (c) Withholding of Federal Matching Payments for States That Fail To 
Report Enrollee Encounter Data in the Medicaid Statistical Information 
System.--Section 1903(i) of the Social Security Act (42 U.S.C. 1396b(i)) 
is amended--
            (1) in paragraph (23), by striking ``or'' at the end;
            (2) in paragraph (24), by striking the period at the end and 
        inserting ``; or''; and
            (3) by adding at the end the following new paragraph:.
            ``(25) with respect to any amounts expended for medical 
        assistance for individuals for whom the State does not report 
        enrollee encounter data (as defined by the Secretary) to the 
        Medicaid Statistical Information System (MSIS) in a timely 
        manner (as determined by the Secretary).''.

    (d) Permissive Exclusions and Civil Monetary Penalties.--
            (1) Permissive exclusions.--Section 1128(b) of the Social 
        Security Act (42 U.S.C. 1320a-7(b)) is amended by adding at the 
        end the following new paragraph:
            ``(16) Making false statements or misrepresentation of 
        material facts.--Any individual or entity that knowingly makes 
        or causes to be made any false statement, omission, or 
        misrepresentation of a material fact in any application, 
        agreement, bid, or contract to participate or enroll as a 
        provider of services or supplier under a Federal health care 
        program (as defined in section 1128B(f)), including Medicare 
        Advantage organizations under part C of title XVIII, 
        prescription drug plan sponsors under part D of title XVIII, 
        medicaid managed care organizations under title XIX, and 
        entities that apply to participate as providers of services or 
        suppliers in such managed care organizations and such plans.''.
            (2) Civil monetary penalties.--
                    (A) In general.--Section 1128A(a) of the Social 
                Security Act (42 U.S.C. 1320a-7a(a)) is amended--
                          (i) in paragraph (1)(D), by striking ``was 
                      excluded'' and all that follows through the period 
                      at the end and inserting ``was excluded from the 
                      Federal health care program (as defined in section 
                      1128B(f)) under which the claim was made pursuant 
                      to Federal law.'';
                          (ii) in paragraph (6), by striking ``or'' at 
                      the end;
                          (iii) by inserting after paragraph (7), the 
                      following new paragraphs:
            ``(8) orders or prescribes a medical or other item or 
        service during a period in which the person was excluded from a 
        Federal health care program (as so defined), in the case where 
        the person knows or should know that a claim for such medical or 
        other item or service will be made under such a program;
            ``(9) knowingly makes or causes to be made any false 
        statement, omission, or misrepresentation of a material fact in 
        any application, bid, or contract to participate or enroll as a 
        provider of services or a supplier under a Federal health care 
        program (as so defined), including Medicare Advantage 
        organizations under part C of title XVIII, prescription drug 
        plan sponsors under part D of title XVIII, medicaid managed care 
        organizations under title XIX, and entities that apply to 
        participate

[[Page 124 STAT. 758]]

        as providers of services or suppliers in such managed care 
        organizations and such plans;
            ``(10) knows of an overpayment (as defined in paragraph (4) 
        of section 1128J(d)) and does not report and return the 
        overpayment in accordance with such section;'';
                          (iv) in the first sentence--
                                    (I) by striking the ``or'' after 
                                ``prohibited relationship occurs;''; and
                                    (II) by striking ``act)'' and 
                                inserting ``act; or in cases under 
                                paragraph (9), $50,000 for each false 
                                statement or misrepresentation of a 
                                material fact)''; and
                          (v) in the second sentence, by striking 
                      ``purpose)'' and inserting ``purpose; or in cases 
                      under paragraph (9), an assessment of not more 
                      than 3 times the total amount claimed for each 
                      item or service for which payment was made based 
                      upon the application containing the false 
                      statement or misrepresentation of a material 
                      fact)''.
                    (B) Clarification of treatment of certain charitable 
                and other innocuous programs.--Section 1128A(i)(6) of 
                the Social Security Act (42 U.S.C. 1320a-7a(i)(6)) is 
                amended--
                          (i) in subparagraph (C), by striking ``or'' at 
                      the end;
                          (ii) in subparagraph (D), as redesignated by 
                      section 4331(e) of the Balanced Budget Act of 1997 
                      (Public Law 105-33), by striking the period at the 
                      end and inserting a semicolon;
                          (iii) by redesignating subparagraph (D), as 
                      added by section 4523(c) of such Act, as 
                      subparagraph (E) and striking the period at the 
                      end and inserting ``; or''; and
                          (iv) by adding at the end the following new 
                      subparagraphs:
                    ``(F) <<NOTE: Regulations.>> any other remuneration 
                which promotes access to care and poses a low risk of 
                harm to patients and Federal health care programs (as 
                defined in section 1128B(f) and designated by the 
                Secretary under regulations);
                    ``(G) the offer or transfer of items or services for 
                free or less than fair market value by a person, if--
                          ``(i) the items or services consist of 
                      coupons, rebates, or other rewards from a 
                      retailer;
                          ``(ii) the items or services are offered or 
                      transferred on equal terms available to the 
                      general public, regardless of health insurance 
                      status; and
                          ``(iii) the offer or transfer of the items or 
                      services is not tied to the provision of other 
                      items or services reimbursed in whole or in part 
                      by the program under title XVIII or a State health 
                      care program (as defined in section 1128(h));
                    ``(H) the offer or transfer of items or services for 
                free or less than fair market value by a person, if--
                          ``(i) the items or services are not offered as 
                      part of any advertisement or solicitation;

[[Page 124 STAT. 759]]

                          ``(ii) the items or services are not tied to 
                      the provision of other services reimbursed in 
                      whole or in part by the program under title XVIII 
                      or a State health care program (as so defined);
                          ``(iii) there is a reasonable connection 
                      between the items or services and the medical care 
                      of the individual; and
                          ``(iv) the person provides the items or 
                      services after determining in good faith that the 
                      individual is in financial need; or
                    ``(I) effective on a date specified by the Secretary 
                (but not earlier than January 1, 2011), the waiver by a 
                PDP sponsor of a prescription drug plan under part D of 
                title XVIII or an MA organization offering an MA-PD plan 
                under part C of such title of any copayment for the 
                first fill of a covered part D drug (as defined in 
                section 1860D-2(e)) that is a generic drug for 
                individuals enrolled in the prescription drug plan or 
                MA-PD plan, respectively.''.

    (e) Testimonial Subpoena Authority in Exclusion-only Cases.--Section 
1128(f) of the Social Security Act (42 U.S.C. 1320a-7(f)) is amended by 
adding at the end the following new paragraph:
            ``(4) <<NOTE: Applicability.>> The provisions of subsections 
        (d) and (e) of section 205 shall apply with respect to this 
        section to the same extent as they are applicable with respect 
        to title II. The Secretary may delegate the authority granted by 
        section 205(d) (as made applicable to this section) to the 
        Inspector General of the Department of Health and Human Services 
        for purposes of any investigation under this section.''.

    (f) Health Care Fraud.--
            (1) Kickbacks.--Section 1128B of the Social Security Act (42 
        U.S.C. 1320a-7b) is amended by adding at the end the following 
        new subsection:

    ``(g) In addition to the penalties provided for in this section or 
section 1128A, a claim that includes items or services resulting from a 
violation of this section constitutes a false or fraudulent claim for 
purposes of subchapter III of chapter 37 of title 31, United States 
Code.''.
            (2) Revising the intent requirement.--Section 1128B of the 
        Social Security Act (42 U.S.C. 1320a-7b), as amended by 
        paragraph (1), is amended by adding at the end the following new 
        subsection:

    ``(h) With respect to violations of this section, a person need not 
have actual knowledge of this section or specific intent to commit a 
violation of this section.''.
    (g) Surety Bond Requirements.--
            (1) Durable medical equipment.--Section 1834(a)(16)(B) of 
        the Social Security Act (42 U.S.C. 1395m(a)(16)(B)) is amended 
        by inserting ``that the Secretary determines is commensurate 
        with the volume of the billing of the supplier'' before the 
        period at the end.
            (2) Home health agencies.--Section 1861(o)(7)(C) of the 
        Social Security Act (42 U.S.C. 1395x(o)(7)(C)) is amended by 
        inserting ``that the Secretary determines is commensurate with 
        the volume of the billing of the home health agency'' before the 
        semicolon at the end.
            (3) Requirements for certain other providers of services and 
        suppliers.--Section 1862 of the Social Security Act

[[Page 124 STAT. 760]]

        (42 U.S.C. 1395y) is amended by adding at the end the following 
        new subsection:

    ``(n) Requirement of a Surety Bond for Certain Providers of Services 
and Suppliers.--
            ``(1) In general.--The Secretary may require a provider of 
        services or supplier described in paragraph (2) to provide the 
        Secretary on a continuing basis with a surety bond in a form 
        specified by the Secretary in an amount (not less than $50,000) 
        that the Secretary determines is commensurate with the volume of 
        the billing of the provider of services or supplier. 
        The <<NOTE: Waiver authority.>>  Secretary may waive the 
        requirement of a bond under the preceding sentence in the case 
        of a provider of services or supplier that provides a comparable 
        surety bond under State law.
            ``(2) Provider of services or supplier described.--A 
        provider of services or supplier described in this paragraph is 
        a provider of services or supplier the Secretary determines 
        appropriate based on the level of risk involved with respect to 
        the provider of services or supplier, and consistent with the 
        surety bond requirements under sections 1834(a)(16)(B) and 
        1861(o)(7)(C).''.

    (h) Suspension of Medicare and Medicaid Payments Pending 
Investigation of Credible Allegations of Fraud.--
            (1) Medicare.--Section 1862 of the Social Security Act (42 
        U.S.C. 1395y), as amended by subsection (g)(3), is amended by 
        adding at the end the following new subsection:

    ``(o) Suspension of Payments Pending Investigation of Credible 
Allegations of Fraud.--
            ``(1) In general.-- <<NOTE: Determination.>> The Secretary 
        may suspend payments to a provider of services or supplier under 
        this title pending an investigation of a credible allegation of 
        fraud against the provider of services or supplier, unless the 
        Secretary determines there is good cause not to suspend such 
        payments.
            ``(2) Consultation.--The Secretary shall consult with the 
        Inspector General of the Department of Health and Human Services 
        in determining whether there is a credible allegation of fraud 
        against a provider of services or supplier.
            ``(3) Promulgation of regulations.--The Secretary shall 
        promulgate regulations to carry out this subsection and section 
        1903(i)(2)(C).''.
            (2) Medicaid.--Section 1903(i)(2) of such Act (42 U.S.C. 
        1396b(i)(2)) is amended--
                    (A) in subparagraph (A), by striking ``or'' at the 
                end; and
                    (B) by inserting after subparagraph (B), the 
                following:
                    ``(C) <<NOTE: Determination.>> by any individual or 
                entity to whom the State has failed to suspend payments 
                under the plan during any period when there is pending 
                an investigation of a credible allegation of fraud 
                against the individual or entity, as determined by the 
                State in accordance with regulations promulgated by the 
                Secretary for purposes of section 1862(o) and this 
                subparagraph, unless the State determines in accordance 
                with such regulations there is good cause not to suspend 
                such payments; or''.

    (i) Increased Funding To Fight Fraud and Abuse.--
            (1) In general.--Section 1817(k) of the Social Security Act 
        (42 U.S.C. 1395i(k)) is amended--

[[Page 124 STAT. 761]]

                    (A) by adding at the end the following new 
                paragraph:
            ``(7) Additional funding.--In addition to the funds 
        otherwise appropriated to the Account from the Trust Fund under 
        paragraphs (3) and (4) and for purposes described in paragraphs 
        (3)(C) and (4)(A), there are hereby appropriated an additional 
        $10,000,000 to such Account from such Trust Fund for each of 
        fiscal years 2011 through 2020. The funds appropriated under 
        this paragraph shall be allocated in the same proportion as the 
        total funding appropriated with respect to paragraphs (3)(A) and 
        (4)(A) was allocated with respect to fiscal year 2010, and shall 
        be available without further appropriation until expended.''; 
        and
                    (B) in paragraph (4)(A), by inserting ``until 
                expended'' after ``appropriation''.
            (2) Indexing of amounts appropriated.--
                    (A) Departments of health and human services and 
                justice.--Section 1817(k)(3)(A)(i) of the Social 
                Security Act (42 U.S.C. 1395i(k)(3)(A)(i)) is amended--
                          (i) in subclause (III), by inserting ``and'' 
                      at the end;
                          (ii) in subclause (IV)--
                                    (I) by striking ``for each of fiscal 
                                years 2007, 2008, 2009, and 2010'' and 
                                inserting ``for each fiscal year after 
                                fiscal year 2006''; and
                                    (II) by striking ``; and'' and 
                                inserting a period; and
                          (iii) by striking subclause (V).
                    (B) Office of the inspector general of the 
                department of health and human services.--Section 
                1817(k)(3)(A)(ii) of such Act (42 U.S.C. 
                1395i(k)(3)(A)(ii)) is amended--
                          (i) in subclause (VIII), by inserting ``and'' 
                      at the end;
                          (ii) in subclause (IX)--
                                    (I) by striking ``for each of fiscal 
                                years 2008, 2009, and 2010'' and 
                                inserting ``for each fiscal year after 
                                fiscal year 2007''; and
                                    (II) by striking ``; and'' and 
                                inserting a period; and
                          (iii) by striking subclause (X).
                    (C) Federal bureau of investigation.--Section 
                1817(k)(3)(B) of the Social Security Act (42 U.S.C. 
                1395i(k)(3)(B)) is amended--
                          (i) in clause (vii), by inserting ``and'' at 
                      the end;
                          (ii) in clause (viii)--
                                    (I) by striking ``for each of fiscal 
                                years 2007, 2008, 2009, and 2010'' and 
                                inserting ``for each fiscal year after 
                                fiscal year 2006''; and
                                    (II) by striking ``; and'' and 
                                inserting a period; and
                          (iii) by striking clause (ix).
                    (D) Medicare integrity program.--Section 
                1817(k)(4)(C) of the Social Security Act (42 U.S.C. 
                1395i(k)(4)(C)) is amended by adding at the end the 
                following new clause:
                          ``(ii) For each fiscal year after 2010, by the 
                      percentage increase in the consumer price index 
                      for all urban

[[Page 124 STAT. 762]]

                      consumers (all items; United States city average) 
                      over the previous year.''.

    (j) Medicare Integrity Program and Medicaid Integrity Program.--
            (1) Medicare integrity program.--
                    (A) Requirement to provide performance statistics.--
                Section 1893(c) of the Social Security Act (42 U.S.C. 
                1395ddd(c)) is amended--
                          (i) in paragraph (3), by striking ``and'' at 
                      the end;
                          (ii) by redesignating paragraph (4) as 
                      paragraph (5); and
                          (iii) by inserting after paragraph (3) the 
                      following new paragraph:
            ``(4) the entity agrees to provide the Secretary and the 
        Inspector General of the Department of Health and Human Services 
        with such performance statistics (including the number and 
        amount of overpayments recovered, the number of fraud referrals, 
        and the return on investment of such activities by the entity) 
        as the Secretary or the Inspector General may request; and''.
                    (B) Evaluations and annual report.--Section 1893 of 
                the Social Security Act (42 U.S.C. 1395ddd) is amended 
                by adding at the end the following new subsection:

    ``(i) Evaluations and Annual Report.--
            ``(1) Evaluations.--The Secretary shall conduct evaluations 
        of eligible entities which the Secretary contracts with under 
        the Program not less frequently than every 3 years.
            ``(2) Annual report.--Not later than 180 days after the end 
        of each fiscal year (beginning with fiscal year 2011), the 
        Secretary shall submit a report to Congress which identifies--
                    ``(A) the use of funds, including funds transferred 
                from the Federal Hospital Insurance Trust Fund under 
                section 1817 and the Federal Supplementary Insurance 
                Trust Fund under section 1841, to carry out this 
                section; and
                    ``(B) the effectiveness of the use of such funds.''.
                    (C) Flexibility in pursuing fraud and abuse.--
                Section 1893(a) of the Social Security Act (42 U.S.C. 
                1395ddd(a)) is amended by inserting ``, or otherwise,'' 
                after ``entities''.
            (2) Medicaid integrity program.--
                    (A) Requirement to provide performance statistics.--
                Section 1936(c)(2) of the Social Security Act (42 U.S.C. 
                1396u-6(c)(2)) is amended--
                          (i) by redesignating subparagraph (D) as 
                      subparagraph (E); and
                          (ii) by inserting after subparagraph (C) the 
                      following new subparagraph:
                    ``(D) The entity agrees to provide the Secretary and 
                the Inspector General of the Department of Health and 
                Human Services with such performance statistics 
                (including the number and amount of overpayments 
                recovered, the number of fraud referrals, and the return 
                on investment of such activities by the entity) as the 
                Secretary or the Inspector General may request.''.
                    (B) Evaluations and annual report.--Section 1936(e) 
                of the Social Security Act <<NOTE: 42 USC 1396u-6.>> (42 
                U.S.C. 1396u-7(e)) is amended--

[[Page 124 STAT. 763]]

                          (i) by redesignating paragraph (4) as 
                      paragraph (5); and
                          (ii) by inserting after paragraph (3) the 
                      following new paragraph:
            ``(4) Evaluations.--The Secretary shall conduct evaluations 
        of eligible entities which the Secretary contracts with under 
        the Program not less frequently than every 3 years.''.

    (k) Expanded Application of Hardship Waivers for Exclusions.--
Section 1128(c)(3)(B) of the Social Security Act (42 U.S.C. 1320a-
7(c)(3)(B)) is amended by striking ``individuals entitled to benefits 
under part A of title XVIII or enrolled under part B of such title, or 
both'' and inserting ``beneficiaries (as defined in section 1128A(i)(5)) 
of that program''.

SEC. 6403. ELIMINATION OF DUPLICATION BETWEEN THE HEALTHCARE INTEGRITY 
            AND PROTECTION DATA BANK AND THE NATIONAL PRACTITIONER DATA 
            BANK.

    (a) Information Reported by Federal Agencies and Health Plans.--
Section 1128E of the Social Security Act (42 U.S.C. 1320a-7e) is 
amended--
            (1) by striking subsection (a) and inserting the following:

    ``(a) In General.--The Secretary shall maintain a national health 
care fraud and abuse data collection program under this section for the 
reporting of certain final adverse actions (not including settlements in 
which no findings of liability have been made) against health care 
providers, suppliers, or practitioners as required by subsection (b), 
with access as set forth in subsection (d), and shall furnish the 
information collected under this section to the National Practitioner 
Data Bank established pursuant to the Health Care Quality Improvement 
Act of 1986 (42 U.S.C. 11101 et seq.).'';
            (2) by striking subsection (d) and inserting the following:

    ``(d) Access to Reported Information.--
            ``(1) Availability.--The information collected under this 
        section shall be available from the National Practitioner Data 
        Bank to the agencies, authorities, and officials which are 
        provided under section 1921(b) information reported under 
        section 1921(a).
            ``(2) Fees for disclosure.--The Secretary may establish or 
        approve reasonable fees for the disclosure of information under 
        this section. The amount of such a fee may not exceed the costs 
        of processing the requests for disclosure and of providing such 
        information. Such fees shall be available to the Secretary to 
        cover such costs.'';
            (3) by striking subsection (f) and inserting the following:

    ``(f) Appropriate Coordination.--In implementing this section, the 
Secretary shall provide for the maximum appropriate coordination with 
part B of the Health Care Quality Improvement Act of 1986 (42 U.S.C. 
11131 et seq.) and section 1921.''; and
            (4) in subsection (g)--
                    (A) in paragraph (1)(A)--
                          (i) in clause (iii)--
                                    (I) by striking ``or State'' each 
                                place it appears;
                                    (II) by redesignating subclauses 
                                (II) and (III) as subclauses (III) and 
                                (IV), respectively; and
                                    (III) by inserting after subclause 
                                (I) the following new subclause:

[[Page 124 STAT. 764]]

                                    ``(II) any dismissal or closure of 
                                the proceedings by reason of the 
                                provider, supplier, or practitioner 
                                surrendering their license or leaving 
                                the State or jurisdiction''; and
                          (ii) by striking clause (iv) and inserting the 
                      following:
                          ``(iv) Exclusion from participation in a 
                      Federal health care program (as defined in section 
                      1128B(f)).'';
                    (B) in paragraph (3)--
                          (i) by striking subparagraphs (D) and (E); and
                          (ii) by redesignating subparagraph (F) as 
                      subparagraph (D); and
                    (C) in subparagraph (D) (as so redesignated), by 
                striking ``or State''.

    (b) Information Reported by State Law or Fraud Enforcement 
Agencies.--Section 1921 of the Social Security Act (42 U.S.C. 1396r-2) 
is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                          (i) by striking ``system.--The State'' and all 
                      that follows through the semicolon and inserting 
                      system.--
                    ``(A) Licensing or certification actions.-- 
                <<NOTE: Reports. Regulations.>> The State must have in 
                effect a system of reporting the following information 
                with respect to formal proceedings (as defined by the 
                Secretary in regulations) concluded against a health 
                care practitioner or entity by a State licensing or 
                certification agency:'';
                          (ii) by redesignating subparagraphs (A) 
                      through (D) as clauses (i) through (iv), 
                      respectively, and indenting appropriately;
                          (iii) in subparagraph (A)(iii) (as so 
                      redesignated)--
                                    (I) by striking ``the license of'' 
                                and inserting ``license or the right to 
                                apply for, or renew, a license by''; and
                                    (II) by inserting 
                                ``nonrenewability,'' after ``voluntary 
                                surrender,''; and
                          (iv) by adding at the end the following new 
                      subparagraph:
                    ``(B) Other final adverse actions.-- 
                <<NOTE: Reports.>> The State must have in effect a 
                system of reporting information with respect to any 
                final adverse action (not including settlements in which 
                no findings of liability have been made) taken against a 
                health care provider, supplier, or practitioner by a 
                State law or fraud enforcement agency.''; and
                    (B) in paragraph (2), by striking ``the authority 
                described in paragraph (1)'' and inserting ``a State 
                licensing or certification agency or State law or fraud 
                enforcement agency'';
            (2) in subsection (b)--
                    (A) by striking paragraph (2) and inserting the 
                following:
            ``(2) to State licensing or certification agencies and 
        Federal agencies responsible for the licensing and certification 
        of health care providers, suppliers, and licensed health care 
        practitioners;'';

[[Page 124 STAT. 765]]

                    (B) in each of paragraphs (4) and (6), by inserting 
                ``, but only with respect to information provided 
                pursuant to subsection (a)(1)(A)'' before the comma at 
                the end;
                    (C) by striking paragraph (5) and inserting the 
                following:
            ``(5) to State law or fraud enforcement agencies,'';
                    (D) by redesignating paragraphs (7) and (8) as 
                paragraphs (8) and (9), respectively; and
                    (E) by inserting after paragraph (6) the following 
                new paragraph:
            ``(7) to health plans (as defined in section 1128C(c));'';
            (3) by redesignating subsection (d) as subsection (h), and 
        by inserting after subsection (c) the following new subsections:

    ``(d) Disclosure and Correction of Information.--
            ``(1) Disclosure.--With respect to information reported 
        pursuant to subsection (a)(1), the Secretary shall--
                    ``(A) provide for disclosure of the information, 
                upon request, to the health care practitioner who, or 
                the entity that, is the subject of the information 
                reported; and
                    ``(B) <<NOTE: Procedures.>> establish procedures for 
                the case where the health care practitioner or entity 
                disputes the accuracy of the information reported.
            ``(2) Corrections.-- <<NOTE: Reports. Regulations.>> Each 
        State licensing or certification agency and State law or fraud 
        enforcement agency shall report corrections of information 
        already reported about any formal proceeding or final adverse 
        action described in subsection (a), in such form and manner as 
        the Secretary prescribes by regulation.

    ``(e) Fees for Disclosure.--The Secretary may establish or approve 
reasonable fees for the disclosure of information under this section. 
The amount of such a fee may not exceed the costs of processing the 
requests for disclosure and of providing such information. Such fees 
shall be available to the Secretary to cover such costs.
    ``(f) Protection From Liability for Reporting.--No person or entity, 
including any agency designated by the Secretary in subsection (b), 
shall be held liable in any civil action with respect to any reporting 
of information as required under this section, without knowledge of the 
falsity of the information contained in the report.
    ``(g) References.--For purposes of this section:
            ``(1) State licensing or certification agency.--The term 
        `State licensing or certification agency' includes any authority 
        of a State (or of a political subdivision thereof) responsible 
        for the licensing of health care practitioners (or any peer 
        review organization or private accreditation entity reviewing 
        the services provided by health care practitioners) or entities.
            ``(2) State law or fraud enforcement agency.--The term 
        `State law or fraud enforcement agency' includes--
                    ``(A) a State law enforcement agency; and
                    ``(B) a State medicaid fraud control unit (as 
                defined in section 1903(q)).
            ``(3) Final adverse action.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                term `final adverse action' includes--

[[Page 124 STAT. 766]]

                          ``(i) civil judgments against a health care 
                      provider, supplier, or practitioner in State court 
                      related to the delivery of a health care item or 
                      service;
                          ``(ii) State criminal convictions related to 
                      the delivery of a health care item or service;
                          ``(iii) exclusion from participation in State 
                      health care programs (as defined in section 
                      1128(h));
                          ``(iv) any licensing or certification action 
                      described in subsection (a)(1)(A) taken against a 
                      supplier by a State licensing or certification 
                      agency; and
                          ``(v) any other adjudicated actions or 
                      decisions that the Secretary shall establish by 
                      regulation.
                    ``(B) Exception.--Such term does not include any 
                action with respect to a malpractice claim.''; and
            (4) in subsection (h), as so redesignated, by striking ``The 
        Secretary'' and all that follows through the period at the end 
        and inserting ``In implementing this section, the Secretary 
        shall provide for the maximum appropriate coordination with part 
        B of the Health Care Quality Improvement Act of 1986 (42 U.S.C. 
        11131 et seq.) and section 1128E.''.

    (c) Conforming Amendment.--Section 1128C(a)(1) of the Social 
Security Act (42 U.S.C. 1320a-7c(a)(1)) is amended--
            (1) in subparagraph (C), by adding ``and'' after the comma 
        at the end;
            (2) in subparagraph (D), by striking ``, and'' and inserting 
        a period; and
            (3) by striking subparagraph (E).

    (d) <<NOTE: 42 USC 1320a-7e note.>> Transition Process; Effective 
Date.--
            (1) In general.--Effective on the date of enactment of this 
        Act, the Secretary of Health and Human Services (in this section 
        referred to as the ``Secretary'') shall implement a transition 
        process under which, by not later than the end of the transition 
        period described in paragraph (5), the Secretary shall cease 
        operating the Healthcare Integrity and Protection Data Bank 
        established under section 1128E of the Social Security Act (as 
        in effect before the effective date specified in paragraph (6)) 
        and shall transfer all data collected in the Healthcare 
        Integrity and Protection Data Bank to the National Practitioner 
        Data Bank established pursuant to the Health Care Quality 
        Improvement Act of 1986 (42 U.S.C. 11101 et 
        seq.). <<NOTE: Procedures.>> During such transition process, the 
        Secretary shall have in effect appropriate procedures to ensure 
        that data collection and access to the Healthcare Integrity and 
        Protection Data Bank and the National Practitioner Data Bank are 
        not disrupted.
            (2) Regulations.--The Secretary shall promulgate regulations 
        to carry out the amendments made by subsections (a) and (b).
            (3) Funding.--
                    (A) Availability of fees.--Fees collected pursuant 
                to section 1128E(d)(2) of the Social Security Act prior 
                to the effective date specified in paragraph (6) for the 
                disclosure of information in the Healthcare Integrity 
                and Protection Data Bank shall be available to the 
                Secretary, without fiscal year limitation, for payment 
                of costs related to the transition process described in 
                paragraph (1). Any such fees remaining after the 
                transition period is complete shall

[[Page 124 STAT. 767]]

                be available to the Secretary, without fiscal year 
                limitation, for payment of the costs of operating the 
                National Practitioner Data Bank.
                    (B) Availability of additional funds.--In addition 
                to the fees described in subparagraph (A), any funds 
                available to the Secretary or to the Inspector General 
                of the Department of Health and Human Services for a 
                purpose related to combating health care fraud, waste, 
                or abuse shall be available to the extent necessary for 
                operating the Healthcare Integrity and Protection Data 
                Bank during the transition period, including systems 
                testing and other activities necessary to ensure that 
                information formerly reported to the Healthcare 
                Integrity and Protection Data Bank will be accessible 
                through the National Practitioner Data Bank after the 
                end of such transition period.
            (4) Special provision for access to the national 
        practitioner data bank by the department of veterans affairs.--
                    (A) In general.-- <<NOTE: Time 
                period.>> Notwithstanding any other provision of law, 
                during the 1-year period that begins on the effective 
                date specified in paragraph (6), the information 
                described in subparagraph (B) shall be available from 
                the National Practitioner Data Bank to the Secretary of 
                Veterans Affairs without charge.
                    (B) Information described.--For purposes of 
                subparagraph (A), the information described in this 
                subparagraph is the information that would, but for the 
                amendments made by this section, have been available to 
                the Secretary of Veterans Affairs from the Healthcare 
                Integrity and Protection Data Bank.
            (5) Transition period defined.--For purposes of this 
        subsection, the term ``transition period'' means the period that 
        begins on the date of enactment of this Act and ends on the 
        later of--
                    (A) the date that is 1 year after such date of 
                enactment; or
                    (B) the effective date of the regulations 
                promulgated under paragraph (2).
            (6) Effective date.--The amendments made by subsections (a), 
        (b), and (c) shall take effect on the first day after the final 
        day of the transition period.

SEC. 6404. MAXIMUM PERIOD FOR SUBMISSION OF MEDICARE CLAIMS REDUCED TO 
            NOT MORE THAN 12 MONTHS.

    (a) Reducing Maximum Period for Submission.--
            (1) Part a.--Section 1814(a) of the Social Security Act (42 
        U.S.C. 1395f(a)(1)) is amended--
                    (A) in paragraph (1), by striking ``period of 3 
                calendar years'' and all that follows through the 
                semicolon and inserting ``period ending 1 calendar year 
                after the date of service;''; and
                    (B) by adding at the end the following new sentence: 
                ``In applying paragraph (1), the Secretary may specify 
                exceptions to the 1 calendar year period specified in 
                such paragraph.''
            (2) Part b.--

[[Page 124 STAT. 768]]

                    (A) Section 1842(b)(3) of such Act (42 U.S.C. 
                1395u(b)(3)(B)) is amended--
                          (i) in subparagraph (B), in the flush language 
                      following clause (ii), by striking ``close of the 
                      calendar year following the year in which such 
                      service is furnished (deeming any service 
                      furnished in the last 3 months of any calendar 
                      year to have been furnished in the succeeding 
                      calendar year)'' and inserting ``period ending 1 
                      calendar year after the date of service''; and
                          (ii) by adding at the end the following new 
                      sentence: ``In applying subparagraph (B), the 
                      Secretary may specify exceptions to the 1 calendar 
                      year period specified in such subparagraph.''
                    (B) Section 1835(a) of such Act (42 U.S.C. 1395n(a)) 
                is amended--
                          (i) in paragraph (1), by striking ``period of 
                      3 calendar years'' and all that follows through 
                      the semicolon and inserting ``period ending 1 
                      calendar year after the date of service;''; and
                          (ii) by adding at the end the following new 
                      sentence: ``In applying paragraph (1), the 
                      Secretary may specify exceptions to the 1 calendar 
                      year period specified in such paragraph.''

    (b) <<NOTE: 42 USC 1395f note.>> Effective Date.--
            (1) In general.--The amendments made by subsection (a) shall 
        apply to services furnished on or after January 1, 2010.
            (2) Services furnished before 2010.-- <<NOTE: Deadline.>> In 
        the case of services furnished before January 1, 2010, a bill or 
        request for payment under section 1814(a)(1), 1842(b)(3)(B), or 
        1835(a) shall be filed not later that December 31, 2010.

SEC. 6405. PHYSICIANS WHO ORDER ITEMS OR SERVICES REQUIRED TO BE 
            MEDICARE ENROLLED PHYSICIANS OR ELIGIBLE PROFESSIONALS.

    (a) DME.--Section 1834(a)(11)(B) of the Social Security Act (42 
U.S.C. 1395m(a)(11)(B)) is amended by striking ``physician'' and 
inserting ``physician enrolled under section 1866(j) or an eligible 
professional under section 1848(k)(3)(B) that is enrolled under section 
1866(j)''.
    (b) Home Health Services.--
            (1) Part a.--Section 1814(a)(2) of such Act <<NOTE: 42 USC 
        1395f.>> (42 U.S.C. 1395(a)(2)) is amended in the matter 
        preceding subparagraph (A) by inserting ``in the case of 
        services described in subparagraph (C), a physician enrolled 
        under section 1866(j) or an eligible professional under section 
        1848(k)(3)(B),'' before ``or, in the case of services''.
            (2) Part b.--Section 1835(a)(2) of such Act (42 U.S.C. 
        1395n(a)(2)) is amended in the matter preceding subparagraph (A) 
        by inserting ``, or in the case of services described in 
        subparagraph (A), a physician enrolled under section 1866(j) or 
        an eligible professional under section 1848(k)(3)(B),'' after 
        ``a physician''.

    (c) <<NOTE: 42 USC 1395f note.>> Application to Other Items or 
Services.--The Secretary may extend the requirement applied by the 
amendments made by subsections (a) and (b) to durable medical equipment 
and home health services (relating to requiring certifications and 
written

[[Page 124 STAT. 769]]

orders to be made by enrolled physicians and health professions) to all 
other categories of items or services under title XVIII of the Social 
Security Act (42 U.S.C. 1395 et seq.), including covered part D drugs as 
defined in section 1860D-2(e) of such Act (42 U.S.C. 1395w-102), that 
are ordered, prescribed, or referred by a physician enrolled under 
section 1866(j) of such Act (42 U.S.C. 1395cc(j)) or an eligible 
professional under section 1848(k)(3)(B) of such Act (42 U.S.C. 1395w-
4(k)(3)(B)).

    (d) <<NOTE: 42 USC 1395f note.>> Effective Date.--The amendments 
made by this section shall apply to written orders and certifications 
made on or after July 1, 2010.

SEC. 6406. REQUIREMENT FOR PHYSICIANS TO PROVIDE DOCUMENTATION ON 
            REFERRALS TO PROGRAMS AT HIGH RISK OF WASTE AND ABUSE.

    (a) Physicians and Other Suppliers.--Section 1842(h) of the Social 
Security Act (42 U.S.C. 1395u(h)) is amended by adding at the end the 
following new paragraph:
    ``(9) The Secretary may revoke enrollment, for a period of not more 
than one year for each act, for a physician or supplier under section 
1866(j) if such physician or supplier fails to maintain and, upon 
request of the Secretary, provide access to documentation relating to 
written orders or requests for payment for durable medical equipment, 
certifications for home health services, or referrals for other items or 
services written or ordered by such physician or supplier under this 
title, as specified by the Secretary.''.
    (b) Providers of Services.--Section 1866(a)(1) of such Act (42 
U.S.C. 1395cc) is further amended--
            (1) in subparagraph (U), by striking at the end ``and'';
            (2) in subparagraph (V), by striking the period at the end 
        and adding ``; and''; and
            (3) by adding at the end the following new subparagraph:
                    ``(W) maintain and, upon request of the Secretary, 
                provide access to documentation relating to written 
                orders or requests for payment for durable medical 
                equipment, certifications for home health services, or 
                referrals for other items or services written or ordered 
                by the provider under this title, as specified by the 
                Secretary.''.

    (c) OIG Permissive Exclusion Authority.--Section 1128(b)(11) of the 
Social Security Act (42 U.S.C. 1320a-7(b)(11)) is amended by inserting 
``, ordering, referring for furnishing, or certifying the need for'' 
after ``furnishing''.
    (d) <<NOTE: 42 USC 1320a-7 note.>> Effective Date.--The amendments 
made by this section shall apply to orders, certifications, and 
referrals made on or after January 1, 2010.

SEC. 6407. FACE TO FACE ENCOUNTER WITH PATIENT REQUIRED BEFORE 
            PHYSICIANS MAY CERTIFY ELIGIBILITY FOR HOME HEALTH SERVICES 
            OR DURABLE MEDICAL EQUIPMENT UNDER MEDICARE.

    (a) Condition of Payment for Home Health Services.--
            (1) Part a.--Section 1814(a)(2)(C) of such Act <<NOTE: 42 
        USC 1395f.>> is amended--
                    (A) by striking ``and such services'' and inserting 
                ``such services''; and
                    (B) by inserting after ``care of a physician'' the 
                following: ``, and, in the case of a certification made 
                by a physician after January 1, 2010, prior to making 
                such

[[Page 124 STAT. 770]]

                certification the physician must document that the 
                physician himself or herself has had a face-to-face 
                encounter (including through use of telehealth, subject 
                to the requirements in section 1834(m), and other than 
                with respect to encounters that are incident to services 
                involved) with the individual within a reasonable 
                timeframe as determined by the Secretary''.
            (2) Part b.--Section 1835(a)(2)(A) of the Social Security 
        Act <<NOTE: 42 USC 1395n.>> is amended--
                    (A) by striking ``and'' before ``(iii)''; and
                    (B) by inserting after ``care of a physician'' the 
                following: ``, and (iv) in the case of a certification 
                after January 1, 2010, prior to making such 
                certification the physician must document that the 
                physician has had a face-to-face encounter (including 
                through use of telehealth and other than with respect to 
                encounters that are incident to services involved) with 
                the individual during the 6-month period preceding such 
                certification, or other reasonable timeframe as 
                determined by the Secretary''.

    (b) Condition of Payment for Durable Medical Equipment.--Section 
1834(a)(11)(B) of the Social Security Act (42 U.S.C. 1395m(a)(11)(B)) is 
amended--
            (1) by striking ``Order.--The Secretary'' and inserting 
        ``Order.--
                          ``(i) In general.--The Secretary''; and
            (2) by adding at the end the following new clause:
                          ``(ii) Requirement for face to face 
                      encounter.--The Secretary shall require that such 
                      an order be written pursuant to the physician 
                      documenting that a physician, a physician 
                      assistant, a nurse practitioner, or a clinical 
                      nurse specialist (as those terms are defined in 
                      section 1861(aa)(5)) has had a face-to-face 
                      encounter (including through use of telehealth 
                      under subsection (m) and other than with respect 
                      to encounters that are incident to services 
                      involved) with the individual involved during the 
                      6-month period preceding such written order, or 
                      other reasonable timeframe as determined by the 
                      Secretary.''.

    (c) <<NOTE: 42 USC 1395f note.>> Application to Other Areas Under 
Medicare.--The Secretary may apply the face-to-face encounter 
requirement described in the amendments made by subsections (a) and (b) 
to other items and services for which payment is provided under title 
XVIII of the Social Security Act based upon a finding that such an 
decision would reduce the risk of waste, fraud, or abuse.

    (d) <<NOTE: 42 USC 1395f note.>> Application to Medicaid.--The 
requirements pursuant to the amendments made by subsections (a) and (b) 
shall apply in the case of physicians making certifications for home 
health services under title XIX of the Social Security Act in the same 
manner and to the same extent as such requirements apply in the case of 
physicians making such certifications under title XVIII of such Act.

SEC. 6408. ENHANCED PENALTIES.

    (a) Civil Monetary Penalties for False Statements or Delaying 
Inspections.--Section 1128A(a) of the Social Security Act (42 U.S.C. 
1320a-7a(a)), as amended by section 5002(d)(2)(A), is amended--

[[Page 124 STAT. 771]]

            (1) in paragraph (6), by striking ``or'' at the end; and
            (2) by inserting after paragraph (7) the following new 
        paragraphs:
            ``(8) knowingly makes, uses, or causes to be made or used, a 
        false record or statement material to a false or fraudulent 
        claim for payment for items and services furnished under a 
        Federal health care program; or
            ``(9) fails to grant timely access, upon reasonable request 
        (as defined by the Secretary in regulations), to the Inspector 
        General of the Department of Health and Human Services, for the 
        purpose of audits, investigations, evaluations, or other 
        statutory functions of the Inspector General of the Department 
        of Health and Human Services;''; and
            (3) in the first sentence--
                    (A) by striking ``or in cases under paragraph (7)'' 
                and inserting ``in cases under paragraph (7)''; and
                    (B) by striking ``act)'' and inserting ``act, in 
                cases under paragraph (8), $50,000 for each false record 
                or statement, or in cases under paragraph (9), $15,000 
                for each day of the failure described in such 
                paragraph)''.

    (b) Medicare Advantage and Part D Plans.--
            (1) Ensuring timely inspections relating to contracts with 
        ma organizations.--Section 1857(d)(2) of such Act (42 U.S.C. 
        1395w-27(d)(2)) is amended--
                    (A) in subparagraph (A), by inserting ``timely'' 
                before ``inspect''; and
                    (B) in subparagraph (B), by inserting ``timely'' 
                before ``audit and inspect''.
            (2) Marketing violations.--Section 1857(g)(1) of the Social 
        Security Act (42 U.S.C. 1395w-27(g)(1)) is amended--
                    (A) in subparagraph (F), by striking ``or'' at the 
                end;
                    (B) by inserting after subparagraph (G) the 
                following new subparagraphs:
                    ``(H) except as provided under subparagraph (C) or 
                (D) of section 1860D-1(b)(1), enrolls an individual in 
                any plan under this part without the prior consent of 
                the individual or the designee of the individual;
                    ``(I) transfers an individual enrolled under this 
                part from one plan to another without the prior consent 
                of the individual or the designee of the individual or 
                solely for the purpose of earning a commission;
                    ``(J) fails to comply with marketing restrictions 
                described in subsections (h) and (j) of section 1851 or 
                applicable implementing regulations or guidance; or
                    ``(K) employs or contracts with any individual or 
                entity who engages in the conduct described in 
                subparagraphs (A) through (J) of this paragraph;''; and
                    (C) by adding at the end the following new sentence: 
                ``The <<NOTE: Determination.>> Secretary may provide, in 
                addition to any other remedies authorized by law, for 
                any of the remedies described in paragraph (2), if the 
                Secretary determines that any employee or agent of such 
                organization, or any provider or supplier who contracts 
                with such organization, has engaged in any conduct 
                described in subparagraphs (A) through (K) of this 
                paragraph.''.
            (3) Provision of false information.--Section 1857(g)(2)(A) 
        of the Social Security Act (42 U.S.C. 1395w-

[[Page 124 STAT. 772]]

        27(g)(2)(A)) is amended by inserting ``except with respect to a 
        determination under subparagraph (E), an assessment of not more 
        than the amount claimed by such plan or plan sponsor based upon 
        the misrepresentation or falsified information involved,'' after 
        ``for each such determination,''.

    (c) Obstruction of Program Audits.--Section 1128(b)(2) of the Social 
Security Act (42 U.S.C. 1320a-7(b)(2)) is amended--
            (1) in the heading, by inserting ``or audit'' after 
        ``investigation''; and
            (2) by striking ``investigation into'' and all that follows 
        through the period and inserting ``investigation or audit 
        related to--''
                          ``(i) any offense described in paragraph (1) 
                      or in subsection (a); or
                          ``(ii) the use of funds received, directly or 
                      indirectly, from any Federal health care program 
                      (as defined in section 1128B(f)).''.

    (d) <<NOTE: 42 USC 1320a-7 note.>> Effective Date.--
            (1) In general.--Except as provided in paragraph (2), the 
        amendments made by this section shall apply to acts committed on 
        or after January 1, 2010.
            (2) Exception.--The amendments made by subsection (b)(1) 
        take effect on the date of enactment of this Act.

SEC. 6409. <<NOTE: 42 USC 1395nn note.>> MEDICARE SELF-REFERRAL 
            DISCLOSURE PROTOCOL.

    (a) Development of Self-Referral Disclosure Protocol.--
            (1) <<NOTE: Deadline.>> In general.--The Secretary of Health 
        and Human Services, in cooperation with the Inspector General of 
        the Department of Health and Human Services, shall establish, 
        not later than 6 months after the date of the enactment of this 
        Act, a protocol to enable health care providers of services and 
        suppliers to disclose an actual or potential violation of 
        section 1877 of the Social Security Act (42 U.S.C. 1395nn) 
        pursuant to a self-referral disclosure protocol (in this section 
        referred to as an ``SRDP''). The SRDP shall include direction to 
        health care providers of services and suppliers on--
                    (A) a specific person, official, or office to whom 
                such disclosures shall be made; and
                    (B) instruction on the implication of the SRDP on 
                corporate integrity agreements and corporate compliance 
                agreements.
            (2) Publication on internet website of srdp information.--
        The Secretary of Health and Human Services shall post 
        information on the public Internet website of the Centers for 
        Medicare & Medicaid Services to inform relevant stakeholders of 
        how to disclose actual or potential violations pursuant to an 
        SRDP.
            (3) Relation to advisory opinions.--The SRDP shall be 
        separate from the advisory opinion process set forth in 
        regulations implementing section 1877(g) of the Social Security 
        Act.

    (b) Reduction in Amounts Owed.--The Secretary of Health and Human 
Services is authorized to reduce the amount due and owing for all 
violations under section 1877 of the Social Security Act to an amount 
less than that specified in subsection (g) of such section. In 
establishing such amount for a violation, the Secretary may consider the 
following factors:

[[Page 124 STAT. 773]]

            (1) The nature and extent of the improper or illegal 
        practice.
            (2) The timeliness of such self-disclosure.
            (3) The cooperation in providing additional information 
        related to the disclosure.
            (4) Such other factors as the Secretary considers 
        appropriate.

    (c) Report.--Not later than 18 months after the date on which the 
SRDP protocol is established under subsection (a)(1), the Secretary 
shall submit to Congress a report on the implementation of this section. 
Such report shall include--
            (1) the number of health care providers of services and 
        suppliers making disclosures pursuant to the SRDP;
            (2) the amounts collected pursuant to the SRDP;
            (3) the types of violations reported under the SRDP; and
            (4) such other information as may be necessary to evaluate 
        the impact of this section.

SEC. 6410. ADJUSTMENTS TO THE MEDICARE DURABLE MEDICAL EQUIPMENT, 
            PROSTHETICS, ORTHOTICS, AND SUPPLIES COMPETITIVE ACQUISITION 
            PROGRAM.

    (a) Expansion of Round 2 of the DME Competitive Bidding Program.--
Section 1847(a)(1) of the Social Security Act (42 U.S.C. 1395w-3(a)(1)) 
is amended--
            (1) in subparagraph (B)(i)(II), by striking ``70'' and 
        inserting ``91''; and
            (2) in subparagraph (D)(ii)--
                    (A) in subclause (I), by striking ``and'' at the 
                end;
                    (B) by redesignating subclause (II) as subclause 
                (III); and
                    (C) by inserting after subclause (I) the following 
                new subclause:
                                    ``(II) the Secretary shall include 
                                the next 21 largest metropolitan 
                                statistical areas by total population 
                                (after those selected under subclause 
                                (I)) for such round; and''.

    (b) Requirement to Either Competitively Bid Areas or Use Competitive 
Bid Prices by 2016.--Section 1834(a)(1)(F) of the Social Security Act 
(42 U.S.C. 1395m(a)(1)(F)) is amended--
            (1) in clause (i), by striking ``and'' at the end;
            (2) in clause (ii)--
                    (A) by inserting ``(and, in the case of covered 
                items furnished on or after January 1, 2016, subject to 
                clause (iii), shall)'' after ``may''; and
                    (B) by striking the period at the end and inserting 
                ``; and''; and
            (3) by adding at the end the following new clause:
                          ``(iii) in the case of covered items furnished 
                      on or after January 1, 2016, the Secretary shall 
                      continue to make such adjustments described in 
                      clause (ii) as, under such competitive acquisition 
                      programs, additional covered items are phased in 
                      or information is updated as contracts under 
                      section 1847 are recompeted in accordance with 
                      section 1847(b)(3)(B).''.

SEC. 6411. EXPANSION OF THE RECOVERY AUDIT CONTRACTOR (RAC) PROGRAM.

    (a) Expansion to Medicaid.--

[[Page 124 STAT. 774]]

            (1) State plan amendment.--Section 1902(a)(42) of the Social 
        Security Act (42 U.S.C. 1396a(a)(42)) is amended--
                    (A) by striking ``that the records'' and inserting 
                ``that--
                    ``(A) the records'';
                    (B) by inserting ``and'' after the semicolon; and
                    (C) by adding at the end the following:
                    ``(B) <<NOTE: Deadline.>> not later than December 
                31, 2010, the State shall--
                          ``(i) establish a program under which the 
                      State contracts (consistent with State law and in 
                      the same manner as the Secretary enters into 
                      contracts with recovery audit contractors under 
                      section 1893(h), subject to such exceptions or 
                      requirements as the Secretary may require for 
                      purposes of this title or a particular State) with 
                      1 or more recovery audit contractors for the 
                      purpose of identifying underpayments and 
                      overpayments and recouping overpayments under the 
                      State plan and under any waiver of the State plan 
                      with respect to all services for which payment is 
                      made to any entity under such plan or waiver; and
                          ``(ii) provide assurances satisfactory to the 
                      Secretary that--
                                    ``(I) under such contracts, payment 
                                shall be made to such a contractor only 
                                from amounts recovered;
                                    ``(II) from such amounts recovered, 
                                payment--
                                            ``(aa) shall be made on a 
                                        contingent basis for collecting 
                                        overpayments; and
                                            ``(bb) may be made in such 
                                        amounts as the State may specify 
                                        for identifying underpayments;
                                    ``(III) the State has an adequate 
                                process for entities to appeal any 
                                adverse determination made by such 
                                contractors; and
                                    ``(IV) such program is carried out 
                                in accordance with such requirements as 
                                the Secretary shall specify, including--
                                            ``(aa) for purposes of 
                                        section 1903(a)(7), that amounts 
                                        expended by the State to carry 
                                        out the program shall be 
                                        considered amounts expended as 
                                        necessary for the proper and 
                                        efficient administration of the 
                                        State plan or a waiver of the 
                                        plan;
                                            ``(bb) that section 1903(d) 
                                        shall apply to amounts recovered 
                                        under the program; and
                                            ``(cc) that the State and 
                                        any such contractors under 
                                        contract with the State shall 
                                        coordinate such recovery audit 
                                        efforts with other contractors 
                                        or entities performing audits of 
                                        entities receiving payments 
                                        under the State plan or waiver 
                                        in the State, including efforts 
                                        with Federal and State law 
                                        enforcement with respect to the 
                                        Department of Justice, including 
                                        the Federal Bureau of 
                                        Investigations, the Inspector 
                                        General of the Department of 
                                        Health and Human Services, and 
                                        the State medicaid fraud control 
                                        unit; and''.

[[Page 124 STAT. 775]]

            (2) <<NOTE: 42 USC 1396a note.>> Coordination; 
        regulations.--
                    (A) In general.--The Secretary of Health and Human 
                Services, acting through the Administrator of the 
                Centers for Medicare & Medicaid Services, shall 
                coordinate the expansion of the Recovery Audit 
                Contractor program to Medicaid with States, particularly 
                with respect to each State that enters into a contract 
                with a recovery audit contractor for purposes of the 
                State's Medicaid program prior to December 31, 2010.
                    (B) Regulations.--The Secretary of Health and Human 
                Services shall promulgate regulations to carry out this 
                subsection and the amendments made by this subsection, 
                including with respect to conditions of Federal 
                financial participation, as specified by the Secretary.

    (b) Expansion to Medicare Parts C and D.--Section 1893(h) of the 
Social Security Act (42 U.S.C. 1395ddd(h)) is amended--
            (1) in paragraph (1), in the matter preceding subparagraph 
        (A), by striking ``part A or B'' and inserting ``this title'';
            (2) in paragraph (2), by striking ``parts A and B'' and 
        inserting ``this title'';
            (3) in paragraph (3), by inserting ``(not later than 
        December 31, 2010, in the case of contracts relating to payments 
        made under part C or D)'' after ``2010'';
            (4) in paragraph (4), in the matter preceding subparagraph 
        (A), by striking ``part A or B'' and inserting ``this title''; 
        and
            (5) by adding at the end the following:
            ``(9) Special rules relating to parts c and d.--The 
        Secretary shall enter into contracts under paragraph (1) to 
        require recovery audit contractors to--
                    ``(A) ensure that each MA plan under part C has an 
                anti-fraud plan in effect and to review the 
                effectiveness of each such anti-fraud plan;
                    ``(B) ensure that each prescription drug plan under 
                part D has an anti-fraud plan in effect and to review 
                the effectiveness of each such anti-fraud plan;
                    ``(C) examine claims for reinsurance payments under 
                section 1860D-15(b) to determine whether prescription 
                drug plans submitting such claims incurred costs in 
                excess of the allowable reinsurance costs permitted 
                under paragraph (2) of that section; and
                    ``(D) review estimates submitted by prescription 
                drug plans by private plans with respect to the 
                enrollment of high cost beneficiaries (as defined by the 
                Secretary) and to compare such estimates with the 
                numbers of such beneficiaries actually enrolled by such 
                plans.''.

    (c) <<NOTE: 42 USC 1396a note.>> Annual Report.--The Secretary of 
Health and Human Services, acting through the Administrator of the 
Centers for Medicare & Medicaid Services, shall submit an annual report 
to Congress concerning the effectiveness of the Recovery Audit 
Contractor program under Medicaid and Medicare and shall include such 
reports recommendations for expanding or improving the program.

[[Page 124 STAT. 776]]

      Subtitle F--Additional Medicaid Program Integrity Provisions

SEC. 6501. TERMINATION OF PROVIDER PARTICIPATION UNDER MEDICAID IF 
            TERMINATED UNDER MEDICARE OR OTHER STATE PLAN.

    Section 1902(a)(39) of the Social Security Act (42 U.S.C. 42 U.S.C. 
1396a(a)) is amended by inserting after ``1128A,'' the following: 
``terminate the participation of any individual or entity in such 
program if (subject to such exceptions as are permitted with respect to 
exclusion under sections 1128(c)(3)(B) and 1128(d)(3)(B)) participation 
of such individual or entity is terminated under title XVIII or any 
other State plan under this title,''.

SEC. 6502. MEDICAID EXCLUSION FROM PARTICIPATION RELATING TO CERTAIN 
            OWNERSHIP, CONTROL, AND MANAGEMENT AFFILIATIONS.

    Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)), as 
amended by section 6401(b), is amended by inserting after paragraph (77) 
the following:
            ``(78) provide that the State agency described in paragraph 
        (9) exclude, with respect to a period, any individual or entity 
        from participation in the program under the State plan if such 
        individual or entity owns, controls, or manages an entity that 
        (or if such entity is owned, controlled, or managed by an 
        individual or entity that)--
                    ``(A) has unpaid overpayments (as defined by the 
                Secretary) under this title during such period 
                determined by the Secretary or the State agency to be 
                delinquent;
                    ``(B) is suspended or excluded from participation 
                under or whose participation is terminated under this 
                title during such period; or
                    ``(C) is affiliated with an individual or entity 
                that has been suspended or excluded from participation 
                under this title or whose participation is terminated 
                under this title during such period;''.

SEC. 6503. BILLING AGENTS, CLEARINGHOUSES, OR OTHER ALTERNATE PAYEES 
            REQUIRED TO REGISTER UNDER MEDICAID.

    (a) In General.--Section 1902(a) of the Social Security Act (42 
U.S.C. 42 U.S.C. 1396a(a)), as amended by section 6502(a), is amended by 
inserting after paragraph (78), the following:
            ``(79) provide that any agent, clearinghouse, or other 
        alternate payee (as defined by the Secretary) that submits 
        claims on behalf of a health care provider must register with 
        the State and the Secretary in a form and manner specified by 
        the Secretary;''.

SEC. 6504. REQUIREMENT TO REPORT EXPANDED SET OF DATA ELEMENTS UNDER 
            MMIS TO DETECT FRAUD AND ABUSE.

    (a) <<NOTE: Determination.>> In General.--Section 1903(r)(1)(F) of 
the Social Security Act (42 U.S.C. 1396b(r)(1)(F)) is amended by 
inserting after ``necessary'' the following: ``and including, for data 
submitted to the Secretary on or after January 1, 2010, data elements 
from the

[[Page 124 STAT. 777]]

automated data system that the Secretary determines to be necessary for 
program integrity, program oversight, and administration, at such 
frequency as the Secretary shall determine''.

    (b) Managed Care Organizations.--
            (1) In general.--Section 1903(m)(2)(A)(xi) of the Social 
        Security Act (42 U.S.C. 1396b(m)(2)(A)(xi)) is amended by 
        inserting ``and for the provision of such data to the State at a 
        frequency and level of detail to be specified by the Secretary'' 
        after ``patients''.
            (2) <<NOTE: 42 USC 1396b note.>> Effective date.--The 
        amendment made by paragraph (1) shall apply with respect to 
        contract years beginning on or after January 1, 2010.

SEC. 6505. PROHIBITION ON PAYMENTS TO INSTITUTIONS OR ENTITIES LOCATED 
            OUTSIDE OF THE UNITED STATES.

    Section 1902(a) of the Social Security Act <<NOTE: 42 USC 
1396a.>> (42 U.S.C. 1396b(a)), as amended by section 6503, is amended by 
inserting after paragraph (79) the following new paragraph:
            ``(80) provide that the State shall not provide any payments 
        for items or services provided under the State plan or under a 
        waiver to any financial institution or entity located outside of 
        the United States;''.

SEC. 6506. OVERPAYMENTS.

    (a) Extension of Period for Collection of Overpayments Due to 
Fraud.--
            (1) In general.--Section 1903(d)(2) of the Social Security 
        Act (42 U.S.C. 1396b(d)(2)) is amended--
                    (A) in subparagraph (C)--
                          (i) in the first sentence, by striking ``60 
                      days'' and inserting ``1 year''; and
                          (ii) in the second sentence, by striking ``60 
                      days'' and inserting ``1-year period''; and
                    (B) in subparagraph (D)--
                          (i) in inserting ``(i)'' after ``(D)''; and
                          (ii) by adding at the end the following:

    ``(ii) In any case where the State is unable to recover a debt which 
represents an overpayment (or any portion thereof) made to a person or 
other entity due to fraud within 1 year of discovery because there is 
not a final determination of the amount of the overpayment under an 
administrative or judicial process (as applicable), including as a 
result of a judgment being under appeal, no adjustment shall be made in 
the Federal payment to such State on account of such overpayment (or 
portion thereof) before the date that is 30 days after the date on which 
a final judgment (including, if applicable, a final determination on an 
appeal) is made.''.
            (2) <<NOTE: 42 USC 1396b note.>> Effective date.--The 
        amendments made by this subsection take effect on the date of 
        enactment of this Act and apply to overpayments discovered on or 
        after that date.

    (b) <<NOTE: Regulations. 42 USC 1396b note.>> Corrective Action.--
The Secretary shall promulgate regulations that require States to 
correct Federally identified claims overpayments, of an ongoing or 
recurring nature, with new Medicaid Management Information System (MMIS) 
edits, audits, or other appropriate corrective action.

[[Page 124 STAT. 778]]

SEC. 6507. MANDATORY STATE USE OF NATIONAL CORRECT CODING INITIATIVE.

    Section 1903(r) of the Social Security Act (42 U.S.C. 1396b(r)) is 
amended--
            (1) in paragraph (1)(B)--
                    (A) in clause (ii), by striking ``and'' at the end;
                    (B) in clause (iii), by adding ``and'' after the 
                semi-colon; and
                    (C) by adding at the end the following new clause:
                          ``(iv) <<NOTE: Effective date.>> effective for 
                      claims filed on or after October 1, 2010, 
                      incorporate compatible methodologies of the 
                      National Correct Coding Initiative administered by 
                      the Secretary (or any successor initiative to 
                      promote correct coding and to control improper 
                      coding leading to inappropriate payment) and such 
                      other methodologies of that Initiative (or such 
                      other national correct coding methodologies) as 
                      the Secretary identifies in accordance with 
                      paragraph (4);''; and
            (2) by adding at the end the following new paragraph:

    ``(4) <<NOTE: Deadlines.>> For purposes of paragraph (1)(B)(iv), the 
Secretary shall do the following:
            ``(A) Not later than September 1, 2010:
                    ``(i) Identify those methodologies of the National 
                Correct Coding Initiative administered by the Secretary 
                (or any successor initiative to promote correct coding 
                and to control improper coding leading to inappropriate 
                payment) which are compatible to claims filed under this 
                title.
                    ``(ii) Identify those methodologies of such 
                Initiative (or such other national correct coding 
                methodologies) that should be incorporated into claims 
                filed under this title with respect to items or services 
                for which States provide medical assistance under this 
                title and no national correct coding methodologies have 
                been established under such Initiative with respect to 
                title XVIII.
                    ``(iii) <<NOTE: Notification.>> Notify States of--
                          ``(I) the methodologies identified under 
                      subparagraphs (A) and (B) (and of any other 
                      national correct coding methodologies identified 
                      under subparagraph (B)); and
                          ``(II) how States are to incorporate such 
                      methodologies into claims filed under this title.
            ``(B) Not later than March 1, 2011, submit a report to 
        Congress that includes the notice to States under clause (iii) 
        of subparagraph (A) and an analysis supporting the 
        identification of the methodologies made under clauses (i) and 
        (ii) of subparagraph (A).''.

SEC. 6508. <<NOTE: 42 USC 1396a note.>> GENERAL EFFECTIVE DATE.

    (a) In General.--Except as otherwise provided in this subtitle, this 
subtitle and the amendments made by this subtitle take effect on January 
1, 2011, without regard to whether final regulations to carry out such 
amendments and subtitle have been promulgated by that date.
    (b) <<NOTE: Determination. Plan.>> Delay if State Legislation 
Required.--In the case of a State plan for medical assistance under 
title XIX of the Social Security Act or a child health plan under title 
XXI of such Act which the Secretary of Health and Human Services 
determines

[[Page 124 STAT. 779]]

requires State legislation (other than legislation appropriating funds) 
in order for the plan to meet the additional requirement imposed by the 
amendments made by this subtitle, the State plan or child health plan 
shall not be regarded as failing to comply with the requirements of such 
title solely on the basis of its failure to meet this additional 
requirement before the first day of the first calendar quarter beginning 
after the close of the first regular session of the State legislature 
that begins after the date of the enactment of this Act. For purposes of 
the previous sentence, in the case of a State that has a 2-year 
legislative session, each year of such session shall be deemed to be a 
separate regular session of the State legislature.

           Subtitle G--Additional Program Integrity Provisions

SEC. 6601. PROHIBITION ON FALSE STATEMENTS AND REPRESENTATIONS.

    (a) Prohibition.--Part 5 of subtitle B of title I of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 1131 et seq.) is 
amended by adding at the end the following:

``SEC. 519. <<NOTE: 29 USC 1149.>> PROHIBITION ON FALSE STATEMENTS AND 
            REPRESENTATIONS.

    ``No person, in connection with a plan or other arrangement that is 
multiple employer welfare arrangement described in section 3(40), shall 
make a false statement or false representation of fact, knowing it to be 
false, in connection with the marketing or sale of such plan or 
arrangement, to any employee, any member of an employee organization, 
any beneficiary, any employer, any employee organization, the Secretary, 
or any State, or the representative or agent of any such person, State, 
or the Secretary, concerning--
            ``(1) the financial condition or solvency of such plan or 
        arrangement;
            ``(2) the benefits provided by such plan or arrangement;
            ``(3) the regulatory status of such plan or other 
        arrangement under any Federal or State law governing collective 
        bargaining, labor management relations, or intern union affairs; 
        or
            ``(4) the regulatory status of such plan or other 
        arrangement regarding exemption from state regulatory authority 
        under this Act.

This section shall not apply to any plan or arrangement that does not 
fall within the meaning of the term `multiple employer welfare 
arrangement' under section 3(40)(A).''.
    (b) Criminal Penalties.--Section 501 of the Employee Retirement 
Income Security Act of 1974 (29 U.S.C. 1131) is amended--
            (1) by inserting ``(a)'' before ``Any person''; and
            (2) by adding at the end the following:

    ``(b) Any person that violates section 519 shall upon conviction be 
imprisoned not more than 10 years or fined under title 18, United States 
Code, or both.''.
    (c) Conforming Amendment.--The table of sections for part 5 of 
subtitle B of title I of the Employee Retirement Income Security Act of 
1974 is amended by adding at the end the following:

``Sec. 519. Prohibition on false statement and representations.''.

[[Page 124 STAT. 780]]

SEC. 6602. CLARIFYING DEFINITION.

    Section 24(a)(2) of title 18, United States Code, is amended by 
inserting ``or section 411, 518, or 511 of the Employee Retirement 
Income Security Act of 1974,'' after ``1954 of this title''.

SEC. 6603. DEVELOPMENT OF MODEL UNIFORM REPORT FORM.

    Part C of title XXVII of the Public Health Service Act (42 U.S.C. 
300gg-91 et seq.) is amended by adding at the end the following:

``SEC. 2794. <<NOTE: 42 USC 300gg-95.>> UNIFORM FRAUD AND ABUSE REFERRAL 
            FORMAT.

    ``The Secretary shall request the National Association of Insurance 
Commissioners to develop a model uniform report form for private health 
insurance issuer seeking to refer suspected fraud and abuse to State 
insurance departments or other responsible State agencies for 
investigation. The Secretary shall request that the National Association 
of Insurance Commissioners develop recommendations for uniform reporting 
standards for such referrals.''.

SEC. 6604. APPLICABILITY OF STATE LAW TO COMBAT FRAUD AND ABUSE.

    (a) In General.--Part 5 of subtitle B of title I of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 1131 et seq.), as 
amended by section 6601, is further amended by adding at the end the 
following:

``SEC. 520. <<NOTE: 29 USC 1150.>> APPLICABILITY OF STATE LAW TO COMBAT 
            FRAUD AND ABUSE.

    ``The Secretary may, for the purpose of identifying, preventing, or 
prosecuting fraud and abuse, adopt regulatory standards establishing, or 
issue an order relating to a specific person establishing, that a person 
engaged in the business of providing insurance through a multiple 
employer welfare arrangement described in section 3(40) is subject to 
the laws of the States in which such person operates which regulate 
insurance in such State, notwithstanding section 514(b)(6) of this Act 
or the Liability Risk Retention Act of 1986, and regardless of whether 
the law of the State is otherwise preempted under any of such 
provisions. This section shall not apply to any plan or arrangement that 
does not fall within the meaning of the term `multiple employer welfare 
arrangement' under section 3(40)(A).''.
    (b) Conforming Amendment.--The table of sections for part 5 of 
subtitle B of title I of the Employee Retirement Income Security Act of 
1974, as amended by section 6601, is further amended by adding at the 
end the following:

``Sec. 520. Applicability of State law to combat fraud and abuse.''.

SEC. 6605. ENABLING THE DEPARTMENT OF LABOR TO ISSUE ADMINISTRATIVE 
            SUMMARY CEASE AND DESIST ORDERS AND SUMMARY SEIZURES ORDERS 
            AGAINST PLANS THAT ARE IN FINANCIALLY HAZARDOUS CONDITION.

    (a) In General.--Part 5 of subtitle B of title I of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 1131 et seq.), as 
amended by section 6604, is further amended by adding at the end the 
following:

[[Page 124 STAT. 781]]

``SEC. 521. <<NOTE: 29 USC 1151.>> ADMINISTRATIVE SUMMARY CEASE AND 
            DESIST ORDERS AND SUMMARY SEIZURE ORDERS AGAINST MULTIPLE 
            EMPLOYER WELFARE ARRANGEMENTS IN FINANCIALLY HAZARDOUS 
            CONDITION.

    ``(a) In General.--The Secretary may issue a cease and desist (ex 
parte) order under this title if it appears to the Secretary that the 
alleged conduct of a multiple employer welfare arrangement described in 
section 3(40), other than a plan or arrangement described in subsection 
(g), is fraudulent, or creates an immediate danger to the public safety 
or welfare, or is causing or can be reasonably expected to cause 
significant, imminent, and irreparable public injury.
    ``(b) Hearing.--A person that is adversely affected by the issuance 
of a cease and desist order under subsection (a) may request a hearing 
by the Secretary regarding such order. The Secretary may require that a 
proceeding under this section, including all related information and 
evidence, be conducted in a confidential manner.
    ``(c) Burden of Proof.--The burden of proof in any hearing conducted 
under subsection (b) shall be on the party requesting the hearing to 
show cause why the cease and desist order should be set aside.
    ``(d) Determination.--Based upon the evidence presented at a hearing 
under subsection (b), the cease and desist order involved may be 
affirmed, modified, or set aside by the Secretary in whole or in part.
    ``(e) Seizure.--The Secretary may issue a summary seizure order 
under this title if it appears that a multiple employer welfare 
arrangement is in a financially hazardous condition.
    ``(f) Regulations.--The Secretary may promulgate such regulations or 
other guidance as may be necessary or appropriate to carry out this 
section.
    ``(g) Exception.--This section shall not apply to any plan or 
arrangement that does not fall within the meaning of the term `multiple 
employer welfare arrangement' under section 3(40)(A).''.
    (b) Conforming Amendment.--The table of sections for part 5 of 
subtitle B of title I of the Employee Retirement Income Security Act of 
1974, as amended by section 6604, is further amended by adding at the 
end the following:

``Sec. 521. Administrative summary cease and desist orders and summary 
           seizure orders against health plans in financially hazardous 
           condition.''.

SEC. 6606. MEWA PLAN REGISTRATION WITH DEPARTMENT OF LABOR.

    Section 101(g) of the Employee Retirement Income Security Act of 
1974 (29 U.S.C. 1021(g)) is amended--
            (1) by striking ``Secretary may'' and inserting ``Secretary 
        shall''; and
            (2) by inserting ``to register with the Secretary prior to 
        operating in a State and may, by regulation, require such 
        multiple employer welfare arrangements'' after ``not group 
        health plans''.

SEC. 6607. PERMITTING EVIDENTIARY PRIVILEGE AND CONFIDENTIAL 
            COMMUNICATIONS.

    Section 504 of the Employee Retirement Income Security Act of 1974 
(29 U.S.C. 1134) is amended by adding at the end the following:

[[Page 124 STAT. 782]]

    ``(d) The Secretary may promulgate a regulation that provides an 
evidentiary privilege for, and provides for the confidentiality of 
communications between or among, any of the following entities or their 
agents, consultants, or employees:
            ``(1) A State insurance department.
            ``(2) A State attorney general.
            ``(3) The National Association of Insurance Commissioners.
            ``(4) The Department of Labor.
            ``(5) The Department of the Treasury.
            ``(6) The Department of Justice.
            ``(7) The Department of Health and Human Services.
            ``(8) Any other Federal or State authority that the 
        Secretary determines is appropriate for the purposes of 
        enforcing the provisions of this title.

    ``(e) <<NOTE: Applicability.>> The privilege established under 
subsection (d) shall apply to communications related to any 
investigation, audit, examination, or inquiry conducted or coordinated 
by any of the agencies. A communication that is privileged under 
subsection (d) shall not waive any privilege otherwise available to the 
communicating agency or to any person who provided the information that 
is communicated.''.

Subtitle H <<NOTE: Elder Justice Act of 2009.>> --Elder Justice Act

SEC. 6701. <<NOTE: 42 USC 1305 note.>> SHORT TITLE OF SUBTITLE.

    This subtitle may be cited as the ``Elder Justice Act of 2009''.

SEC. 6702. <<NOTE: 42 USC 1395i-3a note.>> DEFINITIONS.

    Except as otherwise specifically provided, any term that is defined 
in section 2011 of the Social Security Act (as added by section 6703(a)) 
and is used in this subtitle has the meaning given such term by such 
section.

SEC. 6703. ELDER JUSTICE.

    (a) Elder Justice.--
            (1) In general.--Title XX of the Social Security Act (42 
        U.S.C. 1397 et seq.) is amended--
                    (A) in the heading, by inserting ``AND ELDER 
                JUSTICE'' after ``SOCIAL SERVICES'';
                    (B) by inserting before section 2001 the following:

       ``Subtitle A--Block Grants to States for Social Services'';

                and
                    (C) by adding at the end the following:

                       ``Subtitle B--Elder Justice

``SEC. 2011. <<NOTE: 42 USC 1397j.>> DEFINITIONS.

    ``In this subtitle:
            ``(1) Abuse.--The term `abuse' means the knowing infliction 
        of physical or psychological harm or the knowing deprivation of 
        goods or services that are necessary to meet essential needs or 
        to avoid physical or psychological harm.

[[Page 124 STAT. 783]]

            ``(2) Adult protective services.--The term `adult protective 
        services' means such services provided to adults as the 
        Secretary may specify and includes services such as--
                    ``(A) receiving reports of adult abuse, neglect, or 
                exploitation;
                    ``(B) investigating the reports described in 
                subparagraph (A);
                    ``(C) case planning, monitoring, evaluation, and 
                other case work and services; and
                    ``(D) providing, arranging for, or facilitating the 
                provision of medical, social service, economic, legal, 
                housing, law enforcement, or other protective, 
                emergency, or support services.
            ``(3) Caregiver.--The term `caregiver' means an individual 
        who has the responsibility for the care of an elder, either 
        voluntarily, by contract, by receipt of payment for care, or as 
        a result of the operation of law, and means a family member or 
        other individual who provides (on behalf of such individual or 
        of a public or private agency, organization, or institution) 
        compensated or uncompensated care to an elder who needs 
        supportive services in any setting.
            ``(4) Direct care.--The term `direct care' means care by an 
        employee or contractor who provides assistance or long-term care 
        services to a recipient.
            ``(5) Elder.--The term `elder' means an individual age 60 or 
        older.
            ``(6) Elder justice.--The term `elder justice' means--
                    ``(A) from a societal perspective, efforts to--
                          ``(i) prevent, detect, treat, intervene in, 
                      and prosecute elder abuse, neglect, and 
                      exploitation; and
                          ``(ii) protect elders with diminished capacity 
                      while maximizing their autonomy; and
                    ``(B) from an individual perspective, the 
                recognition of an elder's rights, including the right to 
                be free of abuse, neglect, and exploitation.
            ``(7) Eligible entity.--The term `eligible entity' means a 
        State or local government agency, Indian tribe or tribal 
        organization, or any other public or private entity that is 
        engaged in and has expertise in issues relating to elder justice 
        or in a field necessary to promote elder justice efforts.
            ``(8) Exploitation.--The term `exploitation' means the 
        fraudulent or otherwise illegal, unauthorized, or improper act 
        or process of an individual, including a caregiver or fiduciary, 
        that uses the resources of an elder for monetary or personal 
        benefit, profit, or gain, or that results in depriving an elder 
        of rightful access to, or use of, benefits, resources, 
        belongings, or assets.
            ``(9) Fiduciary.--The term `fiduciary'--
                    ``(A) means a person or entity with the legal 
                responsibility--
                          ``(i) to make decisions on behalf of and for 
                      the benefit of another person; and
                          ``(ii) to act in good faith and with fairness; 
                      and
                    ``(B) includes a trustee, a guardian, a conservator, 
                an executor, an agent under a financial power of 
                attorney or health care power of attorney, or a 
                representative payee.

[[Page 124 STAT. 784]]

            ``(10) Grant.--The term `grant' includes a contract, 
        cooperative agreement, or other mechanism for providing 
        financial assistance.
            ``(11) Guardianship.--The term `guardianship' means--
                    ``(A) the process by which a State court determines 
                that an adult individual lacks capacity to make 
                decisions about self-care or property, and appoints 
                another individual or entity known as a guardian, as a 
                conservator, or by a similar term, as a surrogate 
                decisionmaker;
                    ``(B) the manner in which the court-appointed 
                surrogate decisionmaker carries out duties to the 
                individual and the court; or
                    ``(C) the manner in which the court exercises 
                oversight of the surrogate decisionmaker.
            ``(12) Indian tribe.--
                    ``(A) In general.--The term `Indian tribe' has the 
                meaning given such term in section 4 of the Indian Self-
                Determination and Education Assistance Act (25 U.S.C. 
                450b).
                    ``(B) Inclusion of pueblo and rancheria.--The term 
                `Indian tribe' includes any Pueblo or Rancheria.
            ``(13) Law enforcement.--The term `law enforcement' means 
        the full range of potential responders to elder abuse, neglect, 
        and exploitation including--
                    ``(A) police, sheriffs, detectives, public safety 
                officers, and corrections personnel;
                    ``(B) prosecutors;
                    ``(C) medical examiners;
                    ``(D) investigators; and
                    ``(E) coroners.
            ``(14) Long-term care.--
                    ``(A) In general.--The term `long-term care' means 
                supportive and health services specified by the 
                Secretary for individuals who need assistance because 
                the individuals have a loss of capacity for self-care 
                due to illness, disability, or vulnerability.
                    ``(B) Loss of capacity for self-care.--For purposes 
                of subparagraph (A), the term `loss of capacity for 
                self-care' means an inability to engage in 1 or more 
                activities of daily living, including eating, dressing, 
                bathing, management of one's financial affairs, and 
                other activities the Secretary determines appropriate.
            ``(15) Long-term care facility.--The term `long-term care 
        facility' means a residential care provider that arranges for, 
        or directly provides, long-term care.
            ``(16) Neglect.--The term `neglect' means--
                    ``(A) the failure of a caregiver or fiduciary to 
                provide the goods or services that are necessary to 
                maintain the health or safety of an elder; or
                    ``(B) self-neglect.
            ``(17) Nursing facility.--
                    ``(A) In general.--The term `nursing facility' has 
                the meaning given such term under section 1919(a).
                    ``(B) Inclusion of skilled nursing facility.--The 
                term `nursing facility' includes a skilled nursing 
                facility (as defined in section 1819(a)).

[[Page 124 STAT. 785]]

            ``(18) Self-neglect.--The term `self-neglect' means an 
        adult's inability, due to physical or mental impairment or 
        diminished capacity, to perform essential self-care tasks 
        including--
                    ``(A) obtaining essential food, clothing, shelter, 
                and medical care;
                    ``(B) obtaining goods and services necessary to 
                maintain physical health, mental health, or general 
                safety; or
                    ``(C) managing one's own financial affairs.
            ``(19) Serious bodily injury.--
                    ``(A) In general.--The term `serious bodily injury' 
                means an injury--
                          ``(i) involving extreme physical pain;
                          ``(ii) involving substantial risk of death;
                          ``(iii) involving protracted loss or 
                      impairment of the function of a bodily member, 
                      organ, or mental faculty; or
                          ``(iv) requiring medical intervention such as 
                      surgery, hospitalization, or physical 
                      rehabilitation.
                    ``(B) Criminal sexual abuse.--Serious bodily injury 
                shall be considered to have occurred if the conduct 
                causing the injury is conduct described in section 2241 
                (relating to aggravated sexual abuse) or 2242 (relating 
                to sexual abuse) of title 18, United States Code, or any 
                similar offense under State law.
            ``(20) Social.--The term `social', when used with respect to 
        a service, includes adult protective services.
            ``(21) State legal assistance developer.--The term `State 
        legal assistance developer' means an individual described in 
        section 731 of the Older Americans Act of 1965.
            ``(22) State long-term care ombudsman.--The term `State 
        Long-Term Care Ombudsman' means the State Long-Term Care 
        Ombudsman described in section 712(a)(2) of the Older Americans 
        Act of 1965.

``SEC. 2012. <<NOTE: 42 USC 1397j-1.>> GENERAL PROVISIONS.

    ``(a) Protection of Privacy.--In pursuing activities under this 
subtitle, the Secretary shall ensure the protection of individual health 
privacy consistent with the regulations promulgated under section 264(c) 
of the Health Insurance Portability and Accountability Act of 1996 and 
applicable State and local privacy regulations.
    ``(b) Rule of Construction.--Nothing in this subtitle shall be 
construed to interfere with or abridge an elder's right to practice his 
or her religion through reliance on prayer alone for healing when this 
choice--
            ``(1) is contemporaneously expressed, either orally or in 
        writing, with respect to a specific illness or injury which the 
        elder has at the time of the decision by an elder who is 
        competent at the time of the decision;
            ``(2) is previously set forth in a living will, health care 
        proxy, or other advance directive document that is validly 
        executed and applied under State law; or
            ``(3) may be unambiguously deduced from the elder's life 
        history.

[[Page 124 STAT. 786]]

``PART I--NATIONAL COORDINATION OF ELDER JUSTICE ACTIVITIES AND RESEARCH

 ``Subpart A--Elder Justice Coordinating Council and Advisory Board on 
                 Elder Abuse, Neglect, and Exploitation

``SEC. 2021. <<NOTE: 42 USC 1397k.>> ELDER JUSTICE COORDINATING COUNCIL.

    ``(a) Establishment.--There is established within the Office of the 
Secretary an Elder Justice Coordinating Council (in this section 
referred to as the `Council').
    ``(b) Membership.--
            ``(1) In general.--The Council shall be composed of the 
        following members:
                    ``(A) The Secretary (or the Secretary's designee).
                    ``(B) The Attorney General (or the Attorney 
                General's designee).
                    ``(C) The head of each Federal department or agency 
                or other governmental entity identified by the Chair 
                referred to in subsection (d) as having 
                responsibilities, or administering programs, relating to 
                elder abuse, neglect, and exploitation.
            ``(2) Requirement.--Each member of the Council shall be an 
        officer or employee of the Federal Government.

    ``(c) Vacancies.--Any vacancy in the Council shall not affect its 
powers, but shall be filled in the same manner as the original 
appointment was made.
    ``(d) Chair.--The member described in subsection (b)(1)(A) shall be 
Chair of the Council.
    ``(e) Meetings.--The Council shall meet at least 2 times per year, 
as determined by the Chair.
    ``(f) Duties.--
            ``(1) <<NOTE: Recommenda- tions.>> In general.--The Council 
        shall make recommendations to the Secretary for the coordination 
        of activities of the Department of Health and Human Services, 
        the Department of Justice, and other relevant Federal, State, 
        local, and private agencies and entities, relating to elder 
        abuse, neglect, and exploitation and other crimes against 
        elders.
            ``(2) Report.--Not later than the date that is 2 years after 
        the date of enactment of the Elder Justice Act of 2009 and every 
        2 years thereafter, the Council shall submit to the Committee on 
        Finance of the Senate and the Committee on Ways and Means and 
        the Committee on Energy and Commerce of the House of 
        Representatives a report that--
                    ``(A) describes the activities and accomplishments 
                of, and challenges faced by--
                          ``(i) the Council; and
                          ``(ii) the entities represented on the 
                      Council; and
                    ``(B) makes such recommendations for legislation, 
                model laws, or other action as the Council determines to 
                be appropriate.

    ``(g) Powers of the Council.--
            ``(1) Information from federal agencies.--Subject to the 
        requirements of section 2012(a), the Council may secure directly 
        from any Federal department or agency such information as the 
        Council considers necessary to carry out this section. Upon

[[Page 124 STAT. 787]]

        request of the Chair of the Council, the head of such department 
        or agency shall furnish such information to the Council.
            ``(2) Postal services.--The Council may use the United 
        States mails in the same manner and under the same conditions as 
        other departments and agencies of the Federal Government.

    ``(h) Travel Expenses.--The members of the Council shall not receive 
compensation for the performance of services for the Council. The 
members shall be allowed travel expenses, including per diem in lieu of 
subsistence, at rates authorized for employees of agencies under 
subchapter I of chapter 57 of title 5, United States Code, while away 
from their homes or regular places of business in the performance of 
services for the Council. Notwithstanding section 1342 of title 31, 
United States Code, the Secretary may accept the voluntary and 
uncompensated services of the members of the Council.
    ``(i) Detail of Government Employees.--Any Federal Government 
employee may be detailed to the Council without reimbursement, and such 
detail shall be without interruption or loss of civil service status or 
privilege.
    ``(j) Status as Permanent Council.--Section 14 of the Federal 
Advisory Committee Act (5 U.S.C. App.) shall not apply to the Council.
    ``(k) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as are necessary to carry out this section.

``SEC. 2022. <<NOTE: 42 USC 1397k-1.>> ADVISORY BOARD ON ELDER ABUSE, 
            NEGLECT, AND EXPLOITATION.

    ``(a) Establishment.--There is established a board to be known as 
the `Advisory Board on Elder Abuse, Neglect, and Exploitation' (in this 
section referred to as the `Advisory Board') to create short- and long-
term multidisciplinary strategic plans for the development of the field 
of elder justice and to make recommendations to the Elder Justice 
Coordinating Council established under section 2021.
    ``(b) Composition.--The Advisory Board shall be composed of 27 
members appointed by the Secretary from among members of the general 
public who are individuals with experience and expertise in elder abuse, 
neglect, and exploitation prevention, detection, treatment, 
intervention, or prosecution.
    ``(c) <<NOTE: Notice. Federal Register, publication.>> Solicitation 
of Nominations.--The Secretary shall publish a notice in the Federal 
Register soliciting nominations for the appointment of members of the 
Advisory Board under subsection (b).

    ``(d) Terms.--
            ``(1) In general.--Each member of the Advisory Board shall 
        be appointed for a term of 3 years, except that, of the members 
        first appointed--
                    ``(A) 9 shall be appointed for a term of 3 years;
                    ``(B) 9 shall be appointed for a term of 2 years; 
                and
                    ``(C) 9 shall be appointed for a term of 1 year.
            ``(2) Vacancies.--
                    ``(A) In general.--Any vacancy on the Advisory Board 
                shall not affect its powers, but shall be filled in the 
                same manner as the original appointment was made.
                    ``(B) Filling unexpired term.--An individual chosen 
                to fill a vacancy shall be appointed for the unexpired 
                term of the member replaced.

[[Page 124 STAT. 788]]

            ``(3) Expiration of terms.--The term of any member shall not 
        expire before the date on which the member's successor takes 
        office.

    ``(e) Election of Officers.--The Advisory Board shall elect a Chair 
and Vice Chair from among its members. The Advisory Board shall elect 
its initial Chair and Vice Chair at its initial meeting.
    ``(f) Duties.--
            ``(1) Enhance communication on promoting quality of, and 
        preventing abuse, neglect, and exploitation in, long-term 
        care.--The Advisory Board shall develop collaborative and 
        innovative approaches to improve the quality of, including 
        preventing abuse, neglect, and exploitation in, long-term care.
            ``(2) Collaborative efforts to develop consensus around the 
        management of certain quality-related factors.--
                    ``(A) <<NOTE: Panels.>> In general.--The Advisory 
                Board shall establish multidisciplinary panels to 
                address, and develop consensus on, subjects relating to 
                improving the quality of long-term care. At least 1 such 
                panel shall address, and develop consensus on, methods 
                for managing resident-to-resident abuse in long-term 
                care.
                    ``(B) Activities conducted.--The multidisciplinary 
                panels established under subparagraph (A) shall examine 
                relevant research and data, identify best practices with 
                respect to the subject of the panel, determine the best 
                way to carry out those best practices in a practical and 
                feasible manner, and determine an effective manner of 
                distributing information on such subject.
            ``(3) Report.--Not later than the date that is 18 months 
        after the date of enactment of the Elder Justice Act of 2009, 
        and annually thereafter, the Advisory Board shall prepare and 
        submit to the Elder Justice Coordinating Council, the Committee 
        on Finance of the Senate, and the Committee on Ways and Means 
        and the Committee on Energy and Commerce of the House of 
        Representatives a report containing--
                    ``(A) information on the status of Federal, State, 
                and local public and private elder justice activities;
                    ``(B) recommendations (including recommended 
                priorities) regarding--
                          ``(i) elder justice programs, research, 
                      training, services, practice, enforcement, and 
                      coordination;
                          ``(ii) coordination between entities pursuing 
                      elder justice efforts and those involved in 
                      related areas that may inform or overlap with 
                      elder justice efforts, such as activities to 
                      combat violence against women and child abuse and 
                      neglect; and
                          ``(iii) activities relating to adult fiduciary 
                      systems, including guardianship and other 
                      fiduciary arrangements;
                    ``(C) recommendations for specific modifications 
                needed in Federal and State laws (including regulations) 
                or for programs, research, and training to enhance 
                prevention, detection, and treatment (including 
                diagnosis) of, intervention in (including investigation 
                of), and prosecution of elder abuse, neglect, and 
                exploitation;

[[Page 124 STAT. 789]]

                    ``(D) recommendations on methods for the most 
                effective coordinated national data collection with 
                respect to elder justice, and elder abuse, neglect, and 
                exploitation; and
                    ``(E) recommendations for a multidisciplinary 
                strategic plan to guide the effective and efficient 
                development of the field of elder justice.

    ``(g) Powers of the Advisory Board.--
            ``(1) Information from federal agencies.--Subject to the 
        requirements of section 2012(a), the Advisory Board may secure 
        directly from any Federal department or agency such information 
        as the Advisory Board considers necessary to carry out this 
        section. Upon request of the Chair of the Advisory Board, the 
        head of such department or agency shall furnish such information 
        to the Advisory Board.
            ``(2) Sharing of data and reports.--The Advisory Board may 
        request from any entity pursuing elder justice activities under 
        the Elder Justice Act of 2009 or an amendment made by that Act, 
        any data, reports, or recommendations generated in connection 
        with such activities.
            ``(3) Postal services.--The Advisory Board may use the 
        United States mails in the same manner and under the same 
        conditions as other departments and agencies of the Federal 
        Government.

    ``(h) Travel Expenses.--The members of the Advisory Board shall not 
receive compensation for the performance of services for the Advisory 
Board. The members shall be allowed travel expenses for up to 4 meetings 
per year, including per diem in lieu of subsistence, at rates authorized 
for employees of agencies under subchapter I of chapter 57 of title 5, 
United States Code, while away from their homes or regular places of 
business in the performance of services for the Advisory Board. 
Notwithstanding section 1342 of title 31, United States Code, the 
Secretary may accept the voluntary and uncompensated services of the 
members of the Advisory Board.
    ``(i) Detail of Government Employees.--Any Federal Government 
employee may be detailed to the Advisory Board without reimbursement, 
and such detail shall be without interruption or loss of civil service 
status or privilege.
    ``(j) Status as Permanent Advisory Committee.--Section 14 of the 
Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the 
advisory board.
    ``(k) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as are necessary to carry out this section.

``SEC. 2023. <<NOTE: 42 USC 1397k-2.>> RESEARCH PROTECTIONS.

    ``(a) Guidelines.--The Secretary shall promulgate guidelines to 
assist researchers working in the area of elder abuse, neglect, and 
exploitation, with issues relating to human subject protections.
    ``(b) Definition of Legally Authorized Representative for 
Application of Regulations.--For purposes of the application of subpart 
A of part 46 of title 45, Code of Federal Regulations, to research 
conducted under this subpart, the term `legally authorized 
representative' means, unless otherwise provided by law, the individual 
or judicial or other body authorized under the applicable law to consent 
to medical treatment on behalf of another person.

[[Page 124 STAT. 790]]

``SEC. 2024. <<NOTE: 42 USC 1397k-3.>> AUTHORIZATION OF APPROPRIATIONS.

    ``There are authorized to be appropriated to carry out this 
subpart--
            ``(1) for fiscal year 2011, $6,500,000; and
            ``(2) for each of fiscal years 2012 through 2014, 
        $7,000,000.

  ``Subpart B--Elder Abuse, Neglect, and Exploitation Forensic Centers

``SEC. 2031. <<NOTE: Grants. 42 USC 1397l.>> ESTABLISHMENT AND SUPPORT 
            OF ELDER ABUSE, NEGLECT, AND EXPLOITATION FORENSIC CENTERS.

    ``(a) In General.--The Secretary, in consultation with the Attorney 
General, shall make grants to eligible entities to establish and operate 
stationary and mobile forensic centers, to develop forensic expertise 
regarding, and provide services relating to, elder abuse, neglect, and 
exploitation.
    ``(b) Stationary Forensic Centers.--The Secretary shall make 4 of 
the grants described in subsection (a) to institutions of higher 
education with demonstrated expertise in forensics or commitment to 
preventing or treating elder abuse, neglect, or exploitation, to 
establish and operate stationary forensic centers.
    ``(c) Mobile Centers.--The Secretary shall make 6 of the grants 
described in subsection (a) to appropriate entities to establish and 
operate mobile forensic centers.
    ``(d) Authorized Activities.--
            ``(1) Development of forensic markers and methodologies.--An 
        eligible entity that receives a grant under this section shall 
        use funds made available through the grant to assist in 
        determining whether abuse, neglect, or exploitation occurred and 
        whether a crime was committed and to conduct research to 
        describe and disseminate information on--
                    ``(A) forensic markers that indicate a case in which 
                elder abuse, neglect, or exploitation may have occurred; 
                and
                    ``(B) methodologies for determining, in such a case, 
                when and how health care, emergency service, social and 
                protective services, and legal service providers should 
                intervene and when the providers should report the case 
                to law enforcement authorities.
            ``(2) Development of forensic expertise.--An eligible entity 
        that receives a grant under this section shall use funds made 
        available through the grant to develop forensic expertise 
        regarding elder abuse, neglect, and exploitation in order to 
        provide medical and forensic evaluation, therapeutic 
        intervention, victim support and advocacy, case review, and case 
        tracking.
            ``(3) Collection of evidence.--The Secretary, in 
        coordination with the Attorney General, shall use data made 
        available by grant recipients under this section to develop the 
        capacity of geriatric health care professionals and law 
        enforcement to collect forensic evidence, including collecting 
        forensic evidence relating to a potential determination of elder 
        abuse, neglect, or exploitation.

    ``(e) Application.--To be eligible to receive a grant under this 
section, an entity shall submit an application to the Secretary

[[Page 124 STAT. 791]]

at such time, in such manner, and containing such information as the 
Secretary may require.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section--
            ``(1) for fiscal year 2011, $4,000,000;
            ``(2) for fiscal year 2012, $6,000,000; and
            ``(3) for each of fiscal years 2013 and 2014, $8,000,000.

              ``PART II--PROGRAMS TO PROMOTE ELDER JUSTICE

``SEC. 2041. <<NOTE: 42 USC 1397m.>> ENHANCEMENT OF LONG-TERM CARE.

    ``(a) Grants and Incentives for Long-Term Care Staffing.--
            ``(1) In general.--The Secretary shall carry out activities, 
        including activities described in paragraphs (2) and (3), to 
        provide incentives for individuals to train for, seek, and 
        maintain employment providing direct care in long-term care.
            ``(2) Specific programs to enhance training, recruitment, 
        and retention of staff.--
                    ``(A) Coordination with secretary of labor to 
                recruit and train long-term care staff.--The Secretary 
                shall coordinate activities under this subsection with 
                the Secretary of Labor in order to provide incentives 
                for individuals to train for and seek employment 
                providing direct care in long-term care.
                    ``(B) <<NOTE: Grants.>> Career ladders and wage or 
                benefit increases to increase staffing in long-term 
                care.--
                          ``(i) In general.--The Secretary shall make 
                      grants to eligible entities to carry out programs 
                      through which the entities--
                                    ``(I) offer, to employees who 
                                provide direct care to residents of an 
                                eligible entity or individuals receiving 
                                community-based long-term care from an 
                                eligible entity, continuing training and 
                                varying levels of certification, based 
                                on observed clinical care practices and 
                                the amount of time the employees spend 
                                providing direct care; and
                                    ``(II) provide, or make arrangements 
                                to provide, bonuses or other increased 
                                compensation or benefits to employees 
                                who achieve certification under such a 
                                program.
                          ``(ii) Application.--To be eligible to receive 
                      a grant under this subparagraph, an eligible 
                      entity shall submit an application to the 
                      Secretary at such time, in such manner, and 
                      containing such information as the Secretary may 
                      require (which may include evidence of 
                      consultation with the State in which the eligible 
                      entity is located with respect to carrying out 
                      activities funded under the grant).
                          ``(iii) Authority to limit number of 
                      applicants.--Nothing in this subparagraph shall be 
                      construed as prohibiting the Secretary from 
                      limiting the number of applicants for a grant 
                      under this subparagraph.
            ``(3) <<NOTE: Grants.>> Specific programs to improve 
        management practices.--

[[Page 124 STAT. 792]]

                    ``(A) In general.--The Secretary shall make grants 
                to eligible entities to enable the entities to provide 
                training and technical assistance.
                    ``(B) Authorized activities.--An eligible entity 
                that receives a grant under subparagraph (A) shall use 
                funds made available through the grant to provide 
                training and technical assistance regarding management 
                practices using methods that are demonstrated to promote 
                retention of individuals who provide direct care, such 
                as--
                          ``(i) the establishment of standard human 
                      resource policies that reward high performance, 
                      including policies that provide for improved wages 
                      and benefits on the basis of job reviews;
                          ``(ii) the establishment of motivational and 
                      thoughtful work organization practices;
                          ``(iii) the creation of a workplace culture 
                      that respects and values caregivers and their 
                      needs;
                          ``(iv) the promotion of a workplace culture 
                      that respects the rights of residents of an 
                      eligible entity or individuals receiving 
                      community-based long-term care from an eligible 
                      entity and results in improved care for the 
                      residents or the individuals; and
                          ``(v) the establishment of other programs that 
                      promote the provision of high quality care, such 
                      as a continuing education program that provides 
                      additional hours of training, including on-the-job 
                      training, for employees who are certified nurse 
                      aides.
                    ``(C) Application.--To be eligible to receive a 
                grant under this paragraph, an eligible entity shall 
                submit an application to the Secretary at such time, in 
                such manner, and containing such information as the 
                Secretary may require (which may include evidence of 
                consultation with the State in which the eligible entity 
                is located with respect to carrying out activities 
                funded under the grant).
                    ``(D) Authority to limit number of applicants.--
                Nothing in this paragraph shall be construed as 
                prohibiting the Secretary from limiting the number of 
                applicants for a grant under this paragraph.
            ``(4) Accountability measures.--The Secretary shall develop 
        accountability measures to ensure that the activities conducted 
        using funds made available under this subsection benefit 
        individuals who provide direct care and increase the stability 
        of the long-term care workforce.
            ``(5) Definitions.--In this subsection:
                    ``(A) Community-based long-term care.--The term 
                `community-based long-term care' has the meaning given 
                such term by the Secretary.
                    ``(B) Eligible entity.--The term `eligible entity' 
                means the following:
                          ``(i) A long-term care facility.
                          ``(ii) A community-based long-term care entity 
                      (as defined by the Secretary).

    ``(b) Certified EHR Technology Grant Program.--
            ``(1) Grants authorized.--The Secretary is authorized to 
        make grants to long-term care facilities for the purpose of 
        assisting such entities in offsetting the costs related to 
        purchasing, leasing, developing, and implementing certified EHR

[[Page 124 STAT. 793]]

        technology (as defined in section 1848(o)(4)) designed to 
        improve patient safety and reduce adverse events and health care 
        complications resulting from medication errors.
            ``(2) Use of grant funds.--Funds provided under grants under 
        this subsection may be used for any of the following:
                    ``(A) Purchasing, leasing, and installing computer 
                software and hardware, including handheld computer 
                technologies.
                    ``(B) Making improvements to existing computer 
                software and hardware.
                    ``(C) Making upgrades and other improvements to 
                existing computer software and hardware to enable e-
                prescribing.
                    ``(D) Providing education and training to eligible 
                long-term care facility staff on the use of such 
                technology to implement the electronic transmission of 
                prescription and patient information.
            ``(3) Application.--
                    ``(A) In general.--To be eligible to receive a grant 
                under this subsection, a long-term care facility shall 
                submit an application to the Secretary at such time, in 
                such manner, and containing such information as the 
                Secretary may require (which may include evidence of 
                consultation with the State in which the long-term care 
                facility is located with respect to carrying out 
                activities funded under the grant).
                    ``(B) Authority to limit number of applicants.--
                Nothing in this subsection shall be construed as 
                prohibiting the Secretary from limiting the number of 
                applicants for a grant under this subsection.
            ``(4) Participation in state health exchanges.--A long-term 
        care facility that receives a grant under this subsection shall, 
        where available, participate in activities conducted by a State 
        or a qualified State-designated entity (as defined in section 
        3013(f) of the Public Health Service Act) under a grant under 
        section 3013 of the Public Health Service Act to coordinate care 
        and for other purposes determined appropriate by the Secretary.
            ``(5) Accountability measures.--The Secretary shall develop 
        accountability measures to ensure that the activities conducted 
        using funds made available under this subsection help improve 
        patient safety and reduce adverse events and health care 
        complications resulting from medication errors.

    ``(c) Adoption of Standards for Transactions Involving Clinical Data 
by Long-Term Care Facilities.--
            ``(1) Standards and compatibility.--The Secretary shall 
        adopt electronic standards for the exchange of clinical data by 
        long-term care facilities, including, where available, standards 
        for messaging and nomenclature. Standards adopted by the 
        Secretary under the preceding sentence shall be compatible with 
        standards established under part C of title XI, standards 
        established under subsections (b)(2)(B)(i) and (e)(4) of section 
        1860D-4, standards adopted under section 3004 of the Public 
        Health Service Act, and general health information technology 
        standards.
            ``(2) Electronic submission of data to the secretary.--

[[Page 124 STAT. 794]]

                    ``(A) <<NOTE: Deadline. Procedures.>> In general.--
                Not later than 10 years after the date of enactment of 
                the Elder Justice Act of 2009, the Secretary shall have 
                procedures in place to accept the optional electronic 
                submission of clinical data by long-term care facilities 
                pursuant to the standards adopted under paragraph (1).
                    ``(B) Rule of construction.--Nothing in this 
                subsection shall be construed to require a long-term 
                care facility to submit clinical data electronically to 
                the Secretary.
            ``(3) Regulations.--The Secretary shall promulgate 
        regulations to carry out this subsection. Such regulations shall 
        require a State, as a condition of the receipt of funds under 
        this part, to conduct such data collection and reporting as the 
        Secretary determines are necessary to satisfy the requirements 
        of this subsection.

    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section--
            ``(1) for fiscal year 2011, $20,000,000;
            ``(2) for fiscal year 2012, $17,500,000; and
            ``(3) for each of fiscal years 2013 and 2014, $15,000,000.

``SEC. 2042. <<NOTE: 42 USC 1397m-1.>> ADULT PROTECTIVE SERVICES 
            FUNCTIONS AND GRANT PROGRAMS.

    ``(a) Secretarial Responsibilities.--
            ``(1) In general.--The Secretary shall ensure that the 
        Department of Health and Human Services--
                    ``(A) provides funding authorized by this part to 
                State and local adult protective services offices that 
                investigate reports of the abuse, neglect, and 
                exploitation of elders;
                    ``(B) collects and disseminates data annually 
                relating to the abuse, exploitation, and neglect of 
                elders in coordination with the Department of Justice;
                    ``(C) develops and disseminates information on best 
                practices regarding, and provides training on, carrying 
                out adult protective services;
                    ``(D) conducts research related to the provision of 
                adult protective services; and
                    ``(E) provides technical assistance to States and 
                other entities that provide or fund the provision of 
                adult protective services, including through grants made 
                under subsections (b) and (c).
            ``(2) Authorization of appropriations.--There are authorized 
        to be appropriated to carry out this subsection, $3,000,000 for 
        fiscal year 2011 and $4,000,000 for each of fiscal years 2012 
        through 2014.

    ``(b) Grants To Enhance the Provision of Adult Protective 
Services.--
            ``(1) Establishment.--There is established an adult 
        protective services grant program under which the Secretary 
        shall annually award grants to States in the amounts calculated 
        under paragraph (2) for the purposes of enhancing adult 
        protective services provided by States and local units of 
        government.
            ``(2) Amount of payment.--
                    ``(A) In general.--Subject to the availability of 
                appropriations and subparagraphs (B) and (C), the amount 
                paid to a State for a fiscal year under the program 
                under this

[[Page 124 STAT. 795]]

                subsection shall equal the amount appropriated for that 
                year to carry out this subsection multiplied by the 
                percentage of the total number of elders who reside in 
                the United States who reside in that State.
                    ``(B) Guaranteed minimum payment amount.--
                          ``(i) 50 states.--Subject to clause (ii), if 
                      the amount determined under subparagraph (A) for a 
                      State for a fiscal year is less than 0.75 percent 
                      of the amount appropriated for such year, the 
                      Secretary shall increase such determined amount so 
                      that the total amount paid under this subsection 
                      to the State for the year is equal to 0.75 percent 
                      of the amount so appropriated.
                          ``(ii) 
                      Territories. <<NOTE: Applicability.>> --In the 
                      case of a State other than 1 of the 50 States, 
                      clause (i) shall be applied as if each reference 
                      to `0.75' were a reference to `0.1'.
                    ``(C) Pro rata reductions.--The Secretary shall make 
                such pro rata reductions to the amounts described in 
                subparagraph (A) as are necessary to comply with the 
                requirements of subparagraph (B).
            ``(3) Authorized activities.--
                    ``(A) Adult protective services.--Funds made 
                available pursuant to this subsection may only be used 
                by States and local units of government to provide adult 
                protective services and may not be used for any other 
                purpose.
                    ``(B) Use by agency.--Each State receiving funds 
                pursuant to this subsection shall provide such funds to 
                the agency or unit of State government having legal 
                responsibility for providing adult protective services 
                within the State.
                    ``(C) Supplement not supplant.--Each State or local 
                unit of government shall use funds made available 
                pursuant to this subsection to supplement and not 
                supplant other Federal, State, and local public funds 
                expended to provide adult protective services in the 
                State.
            ``(4) State reports.--Each State receiving funds under this 
        subsection shall submit to the Secretary, at such time and in 
        such manner as the Secretary may require, a report on the number 
        of elders served by the grants awarded under this subsection.
            ``(5) Authorization of appropriations.--There are authorized 
        to be appropriated to carry out this subsection, $100,000,000 
        for each of fiscal years 2011 through 2014.

    ``(c) State Demonstration Programs.--
            ``(1) Establishment.--The Secretary shall award grants to 
        States for the purposes of conducting demonstration programs in 
        accordance with paragraph (2).
            ``(2) Demonstration programs.--Funds made available pursuant 
        to this subsection may be used by States and local units of 
        government to conduct demonstration programs that test--
                    ``(A) training modules developed for the purpose of 
                detecting or preventing elder abuse;
                    ``(B) methods to detect or prevent financial 
                exploitation of elders;
                    ``(C) methods to detect elder abuse;

[[Page 124 STAT. 796]]

                    ``(D) whether training on elder abuse forensics 
                enhances the detection of elder abuse by employees of 
                the State or local unit of government; or
                    ``(E) other matters relating to the detection or 
                prevention of elder abuse.
            ``(3) Application.--To be eligible to receive a grant under 
        this subsection, a State shall submit an application to the 
        Secretary at such time, in such manner, and containing such 
        information as the Secretary may require.
            ``(4) State reports.--Each State that receives funds under 
        this subsection shall submit to the Secretary a report at such 
        time, in such manner, and containing such information as the 
        Secretary may require on the results of the demonstration 
        program conducted by the State using funds made available under 
        this subsection.
            ``(5) Authorization of appropriations.--There are authorized 
        to be appropriated to carry out this subsection, $25,000,000 for 
        each of fiscal years 2011 through 2014.

``SEC. 2043. <<NOTE: 42 USC 1397m-2.>> LONG-TERM CARE OMBUDSMAN PROGRAM 
            GRANTS AND TRAINING.

    ``(a) Grants To Support the Long-Term Care Ombudsman Program.--
            ``(1) In general.--The Secretary shall make grants to 
        eligible entities with relevant expertise and experience in 
        abuse and neglect in long-term care facilities or long-term care 
        ombudsman programs and responsibilities, for the purpose of--
                    ``(A) improving the capacity of State long-term care 
                ombudsman programs to respond to and resolve complaints 
                about abuse and neglect;
                    ``(B) conducting pilot programs with State long-term 
                care ombudsman offices or local ombudsman entities; and
                    ``(C) providing support for such State long-term 
                care ombudsman programs and such pilot programs (such as 
                through the establishment of a national long-term care 
                ombudsman resource center).
            ``(2) Authorization of appropriations.--There are authorized 
        to be appropriated to carry out this subsection--
                    ``(A) for fiscal year 2011, $5,000,000;
                    ``(B) for fiscal year 2012, $7,500,000; and
                    ``(C) for each of fiscal years 2013 and 2014, 
                $10,000,000.

    ``(b) Ombudsman Training Programs.--
            ``(1) In general.--The Secretary shall establish programs to 
        provide and improve ombudsman training with respect to elder 
        abuse, neglect, and exploitation for national organizations and 
        State long-term care ombudsman programs.
            ``(2) Authorization of appropriations.--There are authorized 
        to be appropriated to carry out this subsection, for each of 
        fiscal years 2011 through 2014, $10,000,000.

``SEC. 2044. <<NOTE: 42 USC 1397m-3.>> PROVISION OF INFORMATION 
            REGARDING, AND EVALUATIONS OF, ELDER JUSTICE PROGRAMS.

    ``(a) Provision of Information.--To be eligible to receive a grant 
under this part, an applicant shall agree--
            ``(1) except as provided in paragraph (2), to provide the 
        eligible entity conducting an evaluation under subsection (b) of 
        the activities funded through the grant with such information

[[Page 124 STAT. 797]]

        as the eligible entity may require in order to conduct such 
        evaluation; or
            ``(2) in the case of an applicant for a grant under section 
        2041(b), to provide the Secretary with such information as the 
        Secretary may require to conduct an evaluation or audit under 
        subsection (c).

    ``(b) Use of Eligible Entities To Conduct Evaluations.--
            ``(1) Evaluations required.--Except as provided in paragraph 
        (2), the Secretary shall--
                    ``(A) reserve a portion (not less than 2 percent) of 
                the funds appropriated with respect to each program 
                carried out under this part; and
                    ``(B) use the funds reserved under subparagraph (A) 
                to provide assistance to eligible entities to conduct 
                evaluations of the activities funded under each program 
                carried out under this part.
            ``(2) Certified ehr technology grant program not included.--
        The provisions of this subsection shall not apply to the 
        certified EHR technology grant program under section 2041(b).
            ``(3) Authorized activities.--A recipient of assistance 
        described in paragraph (1)(B) shall use the funds made available 
        through the assistance to conduct a validated evaluation of the 
        effectiveness of the activities funded under a program carried 
        out under this part.
            ``(4) Applications.--To be eligible to receive assistance 
        under paragraph (1)(B), an entity shall submit an application to 
        the Secretary at such time, in such manner, and containing such 
        information as the Secretary may require, including a proposal 
        for the evaluation.
            ``(5) Reports.--Not later than a date specified by the 
        Secretary, an eligible entity receiving assistance under 
        paragraph (1)(B) shall submit to the Secretary, the Committee on 
        Ways and Means and the Committee on Energy and Commerce of the 
        House of Representatives, and the Committee on Finance of the 
        Senate a report containing the results of the evaluation 
        conducted using such assistance together with such 
        recommendations as the entity determines to be appropriate.

    ``(c) Evaluations and Audits of Certified EHR Technology Grant 
Program by the Secretary.--
            ``(1) Evaluations.--The Secretary shall conduct an 
        evaluation of the activities funded under the certified EHR 
        technology grant program under section 2041(b). Such evaluation 
        shall include an evaluation of whether the funding provided 
        under the grant is expended only for the purposes for which it 
        is made.
            ``(2) Audits.--The Secretary shall conduct appropriate 
        audits of grants made under section 2041(b).

``SEC. 2045. <<NOTE: 42 USC 1397m-4.>> REPORT.

    ``Not later than October 1, 2014, the Secretary shall submit to the 
Elder Justice Coordinating Council established under section 2021, the 
Committee on Ways and Means and the Committee on Energy and Commerce of 
the House of Representatives, and the Committee on Finance of the Senate 
a report--

[[Page 124 STAT. 798]]

            ``(1) compiling, summarizing, and analyzing the information 
        contained in the State reports submitted under subsections 
        (b)(4) and (c)(4) of section 2042; and
            ``(2) containing such recommendations for legislative or 
        administrative action as the Secretary determines to be 
        appropriate.

``SEC. 2046. <<NOTE: 42 USC 1397m-5.>> RULE OF CONSTRUCTION.

    ``Nothing in this subtitle shall be construed as--
            ``(1) limiting any cause of action or other relief related 
        to obligations under this subtitle that is available under the 
        law of any State, or political subdivision thereof; or
            ``(2) creating a private cause of action for a violation of 
        this subtitle.''.
            (2) Option for state plan under program for temporary 
        assistance for needy families.--
                    (A) In general.--Section 402(a)(1)(B) of the Social 
                Security Act (42 U.S.C. 602(a)(1)(B)) is amended by 
                adding at the end the following new clause:
                          ``(v) The document shall indicate whether the 
                      State intends to assist individuals to train for, 
                      seek, and maintain employment--
                                    ``(I) providing direct care in a 
                                long-term care facility (as such terms 
                                are defined under section 2011); or
                                    ``(II) in other occupations related 
                                to elder care determined appropriate by 
                                the State for which the State identifies 
                                an unmet need for service personnel,
                      and, if so, shall include an overview of such 
                      assistance.''.
                    (B) <<NOTE: 42 USC 602 note.>> Effective date.--The 
                amendment made by subparagraph (A) shall take effect on 
                January 1, 2011.

    (b) <<NOTE: 42 USC 1395i-3a.>> Protecting Residents of Long-Term 
Care Facilities.--
            (1) National training institute for surveyors.--
                    (A) In general. <<NOTE: Contracts.>> --The Secretary 
                of Health and Human Services shall enter into a contract 
                with an entity for the purpose of establishing and 
                operating a National Training Institute for Federal and 
                State surveyors. Such Institute shall provide and 
                improve the training of surveyors with respect to 
                investigating allegations of abuse, neglect, and 
                misappropriation of property in programs and long-term 
                care facilities that receive payments under title XVIII 
                or XIX of the Social Security Act.
                    (B) Activities carried out by the institute.--The 
                contract entered into under subparagraph (A) shall 
                require the Institute established and operated under 
                such contract to carry out the following activities:
                          (i) Assess the extent to which State agencies 
                      use specialized surveyors for the investigation of 
                      reported allegations of abuse, neglect, and 
                      misappropriation of property in such programs and 
                      long-term care facilities.
                          (ii) Evaluate how the competencies of 
                      surveyors may be improved to more effectively 
                      investigate reported allegations of such abuse, 
                      neglect, and misappropriation of property, and 
                      provide feedback to Federal and State agencies on 
                      the evaluations conducted.

[[Page 124 STAT. 799]]

                          (iii) Provide a national program of training, 
                      tools, and technical assistance to Federal and 
                      State surveyors on investigating reports of such 
                      abuse, neglect, and misappropriation of property.
                          (iv) Develop and disseminate information on 
                      best practices for the investigation of such 
                      abuse, neglect, and misappropriation of property.
                          (v) Assess the performance of State complaint 
                      intake systems, in order to ensure that the intake 
                      of complaints occurs 24 hours per day, 7 days a 
                      week (including holidays).
                          (vi) To the extent approved by the Secretary 
                      of Health and Human Services, provide a national 
                      24 hours per day, 7 days a week (including 
                      holidays), back-up system to State complaint 
                      intake systems in order to ensure optimum national 
                      responsiveness to complaints of such abuse, 
                      neglect, and misappropriation of property.
                          (vii) Analyze and report annually on the 
                      following:
                                    (I) The total number and sources of 
                                complaints of such abuse, neglect, and 
                                misappropriation of property.
                                    (II) The extent to which such 
                                complaints are referred to law 
                                enforcement agencies.
                                    (III) General results of Federal and 
                                State investigations of such complaints.
                          (viii) Conduct a national study of the cost to 
                      State agencies of conducting complaint 
                      investigations of skilled nursing facilities and 
                      nursing facilities under sections 1819 and 1919, 
                      respectively, of the Social Security Act (42 
                      U.S.C. 1395i-3; 1396r), and making recommendations 
                      to the Secretary of Health and Human Services with 
                      respect to options to increase the efficiency and 
                      cost-effectiveness of such investigations.
                    (C) Authorization.--There are authorized to be 
                appropriated to carry out this paragraph, for the period 
                of fiscal years 2011 through 2014, $12,000,000.
            (2) Grants to state survey agencies.--
                    (A) In general.--The Secretary of Health and Human 
                Services shall make grants to State agencies that 
                perform surveys of skilled nursing facilities or nursing 
                facilities under sections 1819 or 1919, respectively, of 
                the Social Security Act (42 U.S.C. 1395i-3; 1395r).
                    (B) Use of funds.--A grant awarded under 
                subparagraph (A) shall be used for the purpose of 
                designing and implementing complaint investigations 
                systems that--
                          (i) promptly prioritize complaints in order to 
                      ensure a rapid response to the most serious and 
                      urgent complaints;
                          (ii) respond to complaints with optimum 
                      effectiveness and timeliness; and
                          (iii) optimize the collaboration between local 
                      authorities, consumers, and providers, including--
                                    (I) such State agency;
                                    (II) the State Long-Term Care 
                                Ombudsman;
                                    (III) local law enforcement 
                                agencies;
                                    (IV) advocacy and consumer 
                                organizations;

[[Page 124 STAT. 800]]

                                    (V) State aging units;
                                    (VI) Area Agencies on Aging; and
                                    (VII) other appropriate entities.
                    (C) Authorization.--There are authorized to be 
                appropriated to carry out this paragraph, for each of 
                fiscal years 2011 through 2014, $5,000,000.
            (3) Reporting of crimes in federally funded long-term care 
        facilities.--Part A of title XI of the Social Security Act (42 
        U.S.C. 1301 et seq.), as amended by section 6005, is amended by 
        inserting after section 1150A the following new section:


 ``reporting to law enforcement of crimes occurring in federally funded 
                        long-term care facilities


    ``Sec. 1150B.  <<NOTE: 42 USC 1320b-25.>> (a) Determination and 
Notification.--
            ``(1) Determination.--The owner or operator of each long-
        term care facility that receives Federal funds under this Act 
        shall annually determine whether the facility received at least 
        $10,000 in such Federal funds during the preceding year.
            ``(2) Notification.--If the owner or operator determines 
        under paragraph (1) that the facility received at least $10,000 
        in such Federal funds during the preceding year, such owner or 
        operator shall annually notify each covered individual (as 
        defined in paragraph (3)) of that individual's obligation to 
        comply with the reporting requirements described in subsection 
        (b).
            ``(3) Covered individual defined.--In this section, the term 
        `covered individual' means each individual who is an owner, 
        operator, employee, manager, agent, or contractor of a long-term 
        care facility that is the subject of a determination described 
        in paragraph (1).

    ``(b) Reporting Requirements.--
            ``(1) In general.--Each covered individual shall report to 
        the Secretary and 1 or more law enforcement entities for the 
        political subdivision in which the facility is located any 
        reasonable suspicion of a crime (as defined by the law of the 
        applicable political subdivision) against any individual who is 
        a resident of, or is receiving care from, the facility.
            ``(2) Timing.--If the events that cause the suspicion--
                    ``(A) result in serious bodily injury, the 
                individual shall report the suspicion immediately, but 
                not later than 2 hours after forming the suspicion; and
                    ``(B) do not result in serious bodily injury, the 
                individual shall report the suspicion not later than 24 
                hours after forming the suspicion.

    ``(c) Penalties.--
            ``(1) In general.--If a covered individual violates 
        subsection (b)--
                    ``(A) the covered individual shall be subject to a 
                civil money penalty of not more than $200,000; and
                    ``(B) the Secretary may make a determination in the 
                same proceeding to exclude the covered individual from 
                participation in any Federal health care program (as 
                defined in section 1128B(f)).
            ``(2) Increased harm.--If a covered individual violates 
        subsection (b) and the violation exacerbates the harm to the 
        victim of the crime or results in harm to another individual--

[[Page 124 STAT. 801]]

                    ``(A) the covered individual shall be subject to a 
                civil money penalty of not more than $300,000; and
                    ``(B) the Secretary may make a determination in the 
                same proceeding to exclude the covered individual from 
                participation in any Federal health care program (as 
                defined in section 1128B(f)).
            ``(3) Excluded individual.--During any period for which a 
        covered individual is classified as an excluded individual under 
        paragraph (1)(B) or (2)(B), a long-term care facility that 
        employs such individual shall be ineligible to receive Federal 
        funds under this Act.
            ``(4) Extenuating circumstances.--
                    ``(A) In general.--The Secretary may take into 
                account the financial burden on providers with 
                underserved populations in determining any penalty to be 
                imposed under this subsection.
                    ``(B) Underserved population defined.--In this 
                paragraph, the term `underserved population' means the 
                population of an area designated by the Secretary as an 
                area with a shortage of elder justice programs or a 
                population group designated by the Secretary as having a 
                shortage of such programs. Such areas or groups 
                designated by the Secretary may include--
                          ``(i) areas or groups that are geographically 
                      isolated (such as isolated in a rural area);
                          ``(ii) racial and ethnic minority populations; 
                      and
                          ``(iii) populations underserved because of 
                      special needs (such as language barriers, 
                      disabilities, alien status, or age).

    ``(d) Additional Penalties for Retaliation.--
            ``(1) In general.--A long-term care facility may not--
                    ``(A) discharge, demote, suspend, threaten, harass, 
                or deny a promotion or other employment-related benefit 
                to an employee, or in any other manner discriminate 
                against an employee in the terms and conditions of 
                employment because of lawful acts done by the employee; 
                or
                    ``(B) file a complaint or a report against a nurse 
                or other employee with the appropriate State 
                professional disciplinary agency because of lawful acts 
                done by the nurse or employee,
        for making a report, causing a report to be made, or for taking 
        steps in furtherance of making a report pursuant to subsection 
        (b)(1).
            ``(2) Penalties for retaliation.--If a long-term care 
        facility violates subparagraph (A) or (B) of paragraph (1) the 
        facility shall be subject to a civil money penalty of not more 
        than $200,000 or the Secretary may classify the entity as an 
        excluded entity for a period of 2 years pursuant to section 
        1128(b), or both.
            ``(3) Requirement to post notice.--Each long-term care 
        facility shall post conspicuously in an appropriate location a 
        sign (in a form specified by the Secretary) specifying the 
        rights of employees under this section. Such sign shall include 
        a statement that an employee may file a complaint with the 
        Secretary against a long-term care facility that violates the 
        provisions of this subsection and information with respect to 
        the manner of filing such a complaint.

[[Page 124 STAT. 802]]

    ``(e) Procedure. <<NOTE: Applicability.>> --The provisions of 
section 1128A (other than subsections (a) and (b) and the second 
sentence of subsection (f)) shall apply to a civil money penalty or 
exclusion under this section in the same manner as such provisions apply 
to a penalty or proceeding under section 1128A(a).

    ``(f) Definitions.--In this section, the terms `elder justice', 
`long-term care facility', and `law enforcement' have the meanings given 
those terms in section 2011.''.
    (c) National Nurse Aide Registry.--
            (1) Definition of nurse aide.--In this subsection, the term 
        ``nurse aide'' has the meaning given that term in sections 
        1819(b)(5)(F) and 1919(b)(5)(F) of the Social Security Act (42 
        U.S.C. 1395i-3(b)(5)(F); 1396r(b)(5)(F)).
            (2) Study and report.--
                    (A) In general.--The Secretary, in consultation with 
                appropriate government agencies and private sector 
                organizations, shall conduct a study on establishing a 
                national nurse aide registry.
                    (B) Areas evaluated.--The study conducted under this 
                subsection shall include an evaluation of--
                          (i) who should be included in the registry;
                          (ii) how such a registry would comply with 
                      Federal and State privacy laws and regulations;
                          (iii) how data would be collected for the 
                      registry;
                          (iv) what entities and individuals would have 
                      access to the data collected;
                          (v) how the registry would provide appropriate 
                      information regarding violations of Federal and 
                      State law by individuals included in the registry;
                          (vi) how the functions of a national nurse 
                      aide registry would be coordinated with the 
                      nationwide program for national and State 
                      background checks on direct patient access 
                      employees of long-term care facilities and 
                      providers under section 4301; and
                          (vii) how the information included in State 
                      nurse aide registries developed and maintained 
                      under sections 1819(e)(2) and 1919(e)(2) of the 
                      Social Security Act (42 U.S.C. 1395i-3(e)(2); 
                      1396r(e)(2)(2)) would be provided as part of a 
                      national nurse aide registry.
                    (C) Considerations.--In conducting the study and 
                preparing the report required under this subsection, the 
                Secretary shall take into consideration the findings and 
                conclusions of relevant reports and other relevant 
                resources, including the following:
                          (i) The Department of Health and Human 
                      Services Office of Inspector General Report, Nurse 
                      Aide Registries: State Compliance and Practices 
                      (February 2005).
                          (ii) The General Accounting Office (now known 
                      as the Government Accountability Office) Report, 
                      Nursing Homes: More Can Be Done to Protect 
                      Residents from Abuse (March 2002).
                          (iii) The Department of Health and Human 
                      Services Office of the Inspector General Report, 
                      Nurse Aide Registries: Long-Term Care Facility 
                      Compliance and Practices (July 2005).

[[Page 124 STAT. 803]]

                          (iv) The Department of Health and Human 
                      Services Health Resources and Services 
                      Administration Report, Nursing Aides, Home Health 
                      Aides, and Related Health Care Occupations--
                      National and Local Workforce Shortages and 
                      Associated Data Needs (2004) (in particular with 
                      respect to chapter 7 and appendix F).
                          (v) The 2001 Report to CMS from the School of 
                      Rural Public Health, Texas A&M University, 
                      Preventing Abuse and Neglect in Nursing Homes: The 
                      Role of Nurse Aide Registries.
                          (vi) Information included in State nurse aide 
                      registries developed and maintained under sections 
                      1819(e)(2) and 1919(e)(2) of the Social Security 
                      Act (42 U.S.C. 1395i-3(e)(2); 1396r(e)(2)(2)).
                    (D) Report.--Not later than 18 months after the date 
                of enactment of this Act, the Secretary shall submit to 
                the Elder Justice Coordinating Council established under 
                section 2021 of the Social Security Act, as added by 
                section 1805(a), the Committee on Finance of the Senate, 
                and the Committee on Ways and Means and the Committee on 
                Energy and Commerce of the House of Representatives a 
                report containing the findings and recommendations of 
                the study conducted under this paragraph.
                    (E) Funding limitation.--Funding for the study 
                conducted under this subsection shall not exceed 
                $500,000.
            (3) Congressional action.--After receiving the report 
        submitted by the Secretary under paragraph (2)(D), the Committee 
        on Finance of the Senate and the Committee on Ways and Means and 
        the Committee on Energy and Commerce of the House of 
        Representatives shall, as they deem appropriate, take action 
        based on the recommendations contained in the report.
            (4) Authorization of appropriations.--There are authorized 
        to be appropriated such sums as are necessary for the purpose of 
        carrying out this subsection.

    (d) Conforming Amendments.--
            (1) Title xx.--Title XX of the Social Security Act (42 
        U.S.C. 1397 et seq.), as amended by section 6703(a), is 
        amended--
                    (A) in the heading of section 2001, <<NOTE: 42 USC 
                1397.>> by striking ``title'' and inserting 
                ``subtitle''; and
                    (B) in subtitle 1, <<NOTE: 42 USC 1397, 1397a, 
                1397c-1397e, 1397g.>> by striking ``this title'' each 
                place it appears and inserting ``this subtitle''.
            (2) Title iv.--Title IV of the Social Security Act (42 
        U.S.C. 601 et seq.) is amended--
                    (A) in section 404(d) <<NOTE: 42 USC 604.>> --
                          (i) in paragraphs (1)(A), (2)(A), and (3)(B), 
                      by inserting ``subtitle 1 of'' before ``title XX'' 
                      each place it appears;
                          (ii) in the heading of paragraph (2), by 
                      inserting ``subtitle 1 of'' before ``title xx''; 
                      and
                          (iii) in the heading of paragraph (3)(B), by 
                      inserting ``subtitle 1 of'' before ``title xx''; 
                      and
                    (B) in sections 422(b), 471(a)(4), 472(h)(1), and 
                473(b)(2), <<NOTE: 42 USC 622, 671-673.>> by inserting 
                ``subtitle 1 of'' before ``title XX'' each place it 
                appears.

[[Page 124 STAT. 804]]

            (3) Title xi.--Title XI of the Social Security Act (42 
        U.S.C. 1301 et seq.) is amended--
                    (A) in section 1128(h)(3) <<NOTE: 42 USC 1320a-
                7.>> --
                          (i) by inserting ``subtitle 1 of'' before 
                      ``title XX''; and
                          (ii) by striking ``such title'' and inserting 
                      ``such subtitle''; and
                    (B) in section 1128A(i)(1), <<NOTE: 42 USC 1320a-
                7a.>> by inserting ``subtitle 1 of'' before ``title 
                XX''.

      Subtitle I--Sense of the Senate Regarding Medical Malpractice

SEC. 6801. SENSE OF THE SENATE REGARDING MEDICAL MALPRACTICE.

    It is the sense of the Senate that--
            (1) health care reform presents an opportunity to address 
        issues related to medical malpractice and medical liability 
        insurance;
            (2) States should be encouraged to develop and test 
        alternatives to the existing civil litigation system as a way of 
        improving patient safety, reducing medical errors, encouraging 
        the efficient resolution of disputes, increasing the 
        availability of prompt and fair resolution of disputes, and 
        improving access to liability insurance, while preserving an 
        individual's right to seek redress in court; and
            (3) Congress should consider establishing a State 
        demonstration program to evaluate alternatives to the existing 
        civil litigation system with respect to the resolution of 
        medical malpractice claims.