[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 454 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                 S. 454

  To amend titles XVIII and XIX of the Social Security Act to prevent 
  fraud, waste, and abuse under Medicare, Medicaid, and CHIP, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 2, 2011

 Mr. Grassley introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
  To amend titles XVIII and XIX of the Social Security Act to prevent 
  fraud, waste, and abuse under Medicare, Medicaid, and CHIP, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Strengthening 
Program Integrity and Accountability in Health Care Act of 2011''.
    (b) Table of Contents.--The table of contents of this title is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Enhanced Medicare and Medicaid program integrity provisions.
Sec. 3. Requirements for the transmission of management implication 
                            reports by the HHS OIG.
Sec. 4. Medical ID theft information sharing program and clearinghouse.
Sec. 5. Permissive exclusion from Federal health care programs expanded 
                            to individuals and entities affiliated with 
                            sanctioned entities.
Sec. 6. Public availability of Medicare claims data.
Sec. 7. Medicaid exclusion from participation relating to certain 
                            ownership, control, and management 
                            affiliations.
Sec. 8. Payment for illegal unapproved drugs.
Sec. 9. Requiring individuals or entities that participate in or 
                            conduct activities under Federal health 
                            care programs to comply with certain 
                            Congressional requests.

SEC. 2. ENHANCED MEDICARE AND MEDICAID PROGRAM INTEGRITY PROVISIONS.

    (a) Mandatory Suspension of Medicare and Medicaid Payments Pending 
Investigation of Credible Allegations of Fraud.--Section 1862(o)(1) of 
the Social Security Act (42 U.S.C. 1395y(o)(1)) is amended by striking 
``may'' and inserting ``shall''.
    (b) Extension of Number of Days in Which Medicare Claims Are 
Required To Be Paid in Order To Prevent or Combat Fraud, Waste, or 
Abuse.--
            (1) Part a claims.--Section 1816(c)(2) of the Social 
        Security Act (42 U.S.C. 1395h(c)(2)) is amended--
                    (A) in subparagraph (B)(ii)(V), by striking ``with 
                respect'' and inserting ``subject to subparagraph (D), 
                with respect''; and
                    (B) by adding at the end the following new 
                subparagraph:
                    ``(D)(i) Upon a determination by the Secretary that 
                there is a likelihood of fraud, waste, or abuse 
                involving a particular category of providers of 
                services or suppliers, categories of providers of 
                services or suppliers in a certain geographic area, or 
                individual providers of services or suppliers, the 
                Secretary shall extend the number of calendar days 
                described in subparagraph (B)(ii)(V) to--
                            ``(I) up to 365 calendar days with respect 
                        to claims submitted by--
                                    ``(aa) categories of providers of 
                                services or suppliers; or
                                    ``(bb) categories of providers of 
                                services or suppliers in a certain 
                                geographic area; or
                            ``(II) such time that the Secretary 
                        determines is necessary to ensure that the 
                        claims with respect to individual providers of 
                        services or suppliers are clean claims.
                    ``(ii) During the extended period of time under 
                subclauses (I) and (II) of clause (ii), the Secretary 
                shall engage in heightened scrutiny of claims, such as 
                prepayment review and other methods the Secretary 
                determines to be appropriate.
                    ``(iii) Not later than 90 days after the date of 
                enactment of this subparagraph and not less than 
                annually thereafter, the Inspector General of the 
                Department of Health and Human Services shall submit to 
                the Secretary a report containing recommendations with 
                respect to the application of this subparagraph and 
                section 1842(c)(2)(D). Not later than 60 days after 
                receiving such a report, the Secretary shall submit to 
                the Inspector General a written response to the 
                recommendations contained in the report.
                    ``(iv) There shall be no administrative or judicial 
                review under section 1869, section 1878, or otherwise 
                of the implementation of this subparagraph by the 
                Secretary.''.
            (2) Part b claims.--Section 1842(c)(2) of the Social 
        Security Act (42 U.S.C. 1395u(c)(2)) is amended--
                    (A) in subparagraph (B)(ii)(V), by striking ``with 
                respect'' and inserting ``subject to subparagraph (D), 
                with respect''; and
                    (B) by adding at the end the following new 
                subparagraph:
                    ``(D)(i) Upon a determination by the Secretary that 
                there is a likelihood of fraud, waste, or abuse 
                involving a particular category of providers of 
                services or suppliers, categories of providers of 
                services or suppliers in a certain geographic area, or 
                individual providers of services or suppliers, the 
                Secretary shall extend the number of calendar days 
                described in subparagraph (B)(ii)(V) to--
                            ``(I) up to 365 calendar days with respect 
                        to claims submitted by--
                                    ``(aa) categories of providers of 
                                services or suppliers; or
                                    ``(bb) categories of providers of 
                                services or suppliers in a certain 
                                geographic area; or
                            ``(II) such time that the Secretary 
                        determines is necessary to ensure that the 
                        claims with respect to individual providers of 
                        services or suppliers are clean claims.
                    ``(ii) During the extended period of time under 
                subclauses (I) and (II) of clause (ii), the Secretary 
                shall engage in heightened scrutiny of claims, such as 
                prepayment review and other methods the Secretary 
                determines to be appropriate.
                    ``(iii) There shall be no administrative or 
                judicial review under section 1869, section 1878, or 
                otherwise of the implementation of this subparagraph by 
                the Secretary.''.
            (3) Effective date.--
                    (A) In general.--The amendments made by this 
                subsection shall take effect on the date that is 6 
                months after the date of the enactment of this Act.
                    (B) Expediting implementation.--The Secretary shall 
                promulgate regulations to carry out the amendments made 
                by this subsection which may be effective and final 
                immediately on an interim basis as of the date of 
                publication of the interim final regulation. If the 
                Secretary provides for an interim final regulation, the 
                Secretary shall provide for a period of public comment 
                on such regulation after the date of publication. The 
                Secretary may change or revise such regulation after 
                completion of the period of public comment.

SEC. 3. REQUIREMENTS FOR THE TRANSMISSION OF MANAGEMENT IMPLICATION 
              REPORTS BY THE HHS OIG.

    Section 1128J of the Social Security Act (42 U.S.C. 1320a-7k) is 
amended by adding at the end the following new subsection:
    ``(f) Transmission of Management Implication Reports by the HHS 
OIG.--
            ``(1) Congressional notification.--Not later than 30 days 
        after the transmission by the Inspector General of the 
        Department of Health and Human Services to another agency of 
        the Department of Health and Human Services of a management 
        implication report, the Inspector General shall notify the 
        relevant committees of Congress of such transmission.
            ``(2) Secretarial response.--The Secretary shall respond to 
        a management implication report transmitted under paragraph (1) 
        not later than 90 days after such transmission.
            ``(3) Relevant committees of congress defined.--In this 
        subsection, the term `relevant committees of Congress' means 
        the Committees on Ways and Means and Energy and Commerce of the 
        House of Representatives and the Committee on Finance of the 
        Senate.''.

SEC. 4. MEDICAL ID THEFT INFORMATION SHARING PROGRAM AND CLEARINGHOUSE.

    (a) Establishment.--Not later than 24 months after the date of 
enactment of this Act, the Secretary of Health and Human Services (in 
this section referred to as the ``Secretary''), acting through the 
Administrator of the Centers for Medicare & Medicaid Services and in 
coordination with the Chairman of the Federal Trade Commission, shall 
establish an information sharing program regarding beneficiary medical 
ID theft under the programs under titles XVIII, XIX, and XXI of the 
Social Security Act (in this section referred to as the ``program'').
    (b) Contents of Program.--The program shall include--
            (1) the establishment of methods to identify and detect 
        relevant warning signs of medical ID theft;
            (2) the establishment of appropriate responses to such 
        warning signs that would mitigate and prevent beneficiary 
        medical ID theft; and
            (3) the development of a detailed plan to update the 
        program as appropriate, taking into consideration such warning 
        signs and appropriate responses.
    (c) Establishment of Clearinghouse.--The Secretary, in coordination 
with the Chairman of the Federal Trade Commission, shall establish a 
clearinghouse at the Centers for Medicare & Medicaid Services that 
collects reports of ID theft against beneficiaries under the programs 
under titles XVIII, XIX, and XXI of the Social Security Act from the 
Federal Trade Commission and other sources determined appropriate by 
the Secretary. Such clearinghouse shall be used to fight medical ID 
theft against beneficiaries and to prevent the improper payment of 
claims under such programs.

SEC. 5. PERMISSIVE EXCLUSION FROM FEDERAL HEALTH CARE PROGRAMS EXPANDED 
              TO INDIVIDUALS AND ENTITIES AFFILIATED WITH SANCTIONED 
              ENTITIES.

    Section 1128(b)(15) of the Social Security Act (42 U.S.C. 1320a-
7(b)(15)) is amended to read as follows:
            ``(15) Individuals or entities affiliated with a sanctioned 
        entity.--(A) Any of the following:
                    ``(i) Any individual who--
                            ``(I) is a person with an ownership or 
                        control interest (as defined in section 
                        1124(a)(3)) in a sanctioned entity or an 
                        affiliated entity of such sanctioned entity (or 
                        was a person with such an interest at the time 
                        of any of the conduct that formed a basis for 
                        the conviction or exclusion described in 
                        subparagraph (B)); and
                            ``(II) knows or should know (as defined in 
                        section 1128A(i)(7)) (or knew or should have 
                        known) of such conduct.
                    ``(ii) Any individual who is an officer or managing 
                employee (as defined in section 1126(b)) of a 
                sanctioned entity or affiliated entity of such 
                sanctioned entity (or was such an officer or managing 
                employee at the time of any of the conduct that formed 
                a basis for the conviction or exclusion described in 
                subparagraph (B)).
                    ``(iii) Any affiliated entity of a sanctioned 
                entity.
            ``(B) For purposes of this paragraph, the term `sanctioned 
        entity' means an entity--
                    ``(i) that has been convicted of any offense 
                described in subsection (a) or in paragraph (1), (2), 
                or (3) of this subsection; or
                    ``(ii) that has been excluded from participation 
                under a program under title XVIII or under a State 
                health care program.
            ``(C)(i) For purposes of this paragraph, the term 
        `affiliated entity' means, with respect to a sanctioned 
        entity--
                    ``(I) an entity affiliated with such sanctioned 
                entity; and
                    ``(II) an entity that was so affiliated at the time 
                of any of the conduct that formed the basis for the 
                conviction or exclusion described in subparagraph (B).
                    ``(ii) For purposes of clause (i), an entity shall 
                be treated as affiliated with another entity if--
                            ``(I) one of the entities is a person with 
                        an ownership or control interest (as defined in 
                        section 1124(a)(3)) in the other entity (or had 
                        such an interest at the time of any of the 
                        conduct that formed a basis for the conviction 
                        or exclusion described in subparagraph (B));
                            ``(II) there is a person with an ownership 
                        or control interest (as defined in section 
                        1124(a)(3)) in both entities (or had such an 
                        interest at the time of any of the conduct that 
                        formed a basis for the conviction or exclusion 
                        described in subparagraph (B)); or
                            ``(III) there is a person who is an officer 
                        or managing employee (as defined in section 
                        1126(b)) of both entities (or was such an 
                        officer or managing employee at the time of any 
                        of the conduct that formed a basis for the 
                        conviction or exclusion described in 
                        subparagraph (B)).''.

SEC. 6. PUBLIC AVAILABILITY OF MEDICARE CLAIMS DATA.

    Section 1128J of the Social Security Act (42 U.S.C. 1320a-7k), as 
amended by section 3, is amended by adding at the end the following new 
subsection:
    ``(g) Public Availability of Medicare Claims Data.--
            ``(1) In general.--The Secretary shall, 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, make available 
        to the public claims and payment data of the Department of 
        Health and Human Services related to title XVIII, including 
        data on payments made to any provider of services or supplier 
        under such title.
            ``(2) Implementation.--Not later than December 31, 2012, 
        the Secretary shall promulgate regulations to carry out this 
        subsection.''.

SEC. 7. 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)) is 
amended--
            (1) by striking ``and'' at the end of paragraph (82);
            (2) by striking the period at the end of paragraph (83) and 
        inserting ``; and''; and
            (3) by inserting after paragraph (83) the following new 
        paragraph:
            ``(84) 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. 8. PAYMENT FOR ILLEGAL UNAPPROVED DRUGS.

    (a) Findings.--Congress finds that each year, the Medicaid program 
under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) 
pays millions of dollars in reimbursement for covered outpatient drugs 
that are not approved by the Food and Drug Administration under a new 
drug application under section 505(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(b)) or an abbreviated new drug application 
under section 505(j) of such Act, or that such drug is not subject to 
such section or section 512 due to the application of section 201(p) of 
such Act (21 U.S.C. 321(p)).
    (b) Listing of Drugs and Devices.--Section 510 of the Federal Food, 
Drug and Cosmetic Act (21 U.S.C. 360) is amended--
            (1) in subsection (j)(1)(B)--
                    (A) in clause (i), by inserting ``in the case of a 
                drug, the authority under this Act that does not 
                require such drug to be subject to section 505 and 
                section 512,'' after ``labeling for such drug or 
                device,''; and
                    (B) in clause (ii), by inserting ``, in the case of 
                a drug, the authority under this Act that does not 
                require such drug to be subject to section 505 and 
                section 512,'' after ``the label and package insert for 
                such drug or device''; and
            (2) in subsection (f)--
                    (A) by striking ``(f) The Secretary'' and inserting 
                the following:
    ``(f) Inspection by Public of Registration.--
            ``(1) In general.--The Secretary''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(2) List of drugs that are not approved under section 505 
        or 512.--Not later than January 1, 2012, the Secretary shall 
        make available to the public on the Internet Web site of the 
        Food and Drug Administration a list that includes, for each 
        drug described in subsection (j)(1)(B)--
                    ``(A) the drug;
                    ``(B) the person who listed such drug; and
                    ``(C) the authority under this Act that does not 
                require such drug to be subject to section 505 and 
                section 512, as provided by such person in such 
                list.''.
    (c) Payment for Covered Outpatient Drugs.--Section 1927 of the 
Social Security Act (42 U.S.C. 1396r-8) is amended by inserting at the 
end the following new subsection:
    ``(l) Condition.--Beginning January 1, 2012, no State shall make 
any payment under this section for any covered outpatient drug unless 
such State first verifies with the Food and Drug Administration that 
such covered outpatient drug has been approved by the Food and Drug 
Administration under a new drug application under section 505(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) or an 
abbreviated new drug application under section 505(j) of such Act, or 
that such drug is not subject to such section or section 512 due to the 
application of section 201(p) of such Act (21 U.S.C. 321(p)). The 
Secretary shall have the authority to proscribe regulations to create 
an information sharing protocol to allow States to verify that a 
covered outpatient drug has been approved by the Food and Drug 
Administration.''.

SEC. 9. REQUIRING INDIVIDUALS OR ENTITIES THAT PARTICIPATE IN OR 
              CONDUCT ACTIVITIES UNDER FEDERAL HEALTH CARE PROGRAMS TO 
              COMPLY WITH CERTAIN CONGRESSIONAL REQUESTS.

    (a) In General.--Section 1128J of the Social Security Act (42 
U.S.C. 1320a-7k), as amended by section 6, is amended by adding at the 
end the following new subsection:
    ``(h) Compliance With Certain Requests by Individuals and Entities 
That Participate in or Conduct Activities Under Federal Health Care 
Programs.--
            ``(1) In general.--Any individual or entity that 
        participates in or conducts activities under a Federal health 
        care program (as defined in section 1128B(f)) shall, as a 
        condition of such participation or such conduct, comply (at a 
        time and in a manner specified by the Chairman or ranking 
        member) with any request submitted by the Chairman or the 
        ranking member of a relevant committee of Congress to the 
        individual or entity for the following:
                    ``(A) Documents.
                    ``(B) Information.
                    ``(C) Interviews.
            ``(2) Relevant committee of congress defined.--In this 
        subsection, the term `relevant committee of Congress' means the 
        Committees on Ways and Means and Energy and Commerce of the 
        House of Representatives and the Committee on Finance of the 
        Senate.''.
    (b) Effective Date.--The amendments made by this section shall take 
effect on the date that is 2 years after the date of enactment of this 
Act.
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