# Medicare Improvements for Patients and Providers Act of 2008/Title I/Subtitle F
## SUBTITLE F — OTHER PROVISIONS
### Sec. 181. Use of PART D Data.

    Section 1860D–12(b)(3)(D) of the Social Security Act (42 U.S.C. 1395w–112(b)(3)(D)) is amended by adding at the end the following sentence: ``Notwithstanding any other provision of law, information provided to the Secretary under the application of section 1857(e)(1) to contracts under this section under the preceding sentence—
          ``(i) may be used for the purposes of carrying out this part, improving public health through research on the utilization, safety, effectiveness, quality, and efficiency of health care services (as the Secretary determines appropriate); and
          ``(ii) shall be made available to Congressional support agencies (in accordance with their obligations to support Congress as set out in their authorizing statutes) for the purposes of conducting Congressional oversight, monitoring, making recommendations, and analysis of the program under this title.´´.

### Sec. 182. Revision of Definition of Medically Accepted Indication for Drugs.

    (a) Revision of Definition for PART D Drugs.—
          (1) In General.—
             Section 1860D–2(e)(1) of the Social Security Act (42 U.S.C. 1395w–102(e)(1)) is amended, in the matter following subparagraph (B)—
                (A) by striking ``(as defined in section 1927(k)(6))´´ and inserting ``(as defined in paragraph (4))´´; and
                (B) by adding at the end the following new paragraph:
                   ``(4) Medically accepted indication defined.—
                      ``(A) In general.—For purposes of paragraph (1), the term ‘medically accepted indication’ has the meaning given that term—
                         ``(i) in the case of a covered part D drug used in an anticancer chemotherapeutic regimen, in section 1861(t)(2)(B), except that in applying such section—
                            ``(I) ‘prescription drug plan or MA–PD plan’ shall be substituted for ‘carrier’ each place it appears; and
                            ``(II) subject to subparagraph (B), the compendia described in section 1927(g)(1)(B)(i)(III) shall be included in the list of compendia described in clause (ii)(I) section 1861(t)(2)(B); and
                         ``(ii) in the case of any other covered part D drug, in section 1927(k)(6).
                      ``(B) Conflict of interest.—On and after January 1, 2010, subparagraph (A)(i)(II) shall not apply unless the compendia described in section 1927(g)(1)(B)(i)(III) meets the requirement in the third sentence of section 1861(t)(2)(B).
                      ``(C) Update.—For purposes of applying subparagraph (A)(ii), the Secretary shall revise the list of compendia described in section 1927(g)(1)(B)(i) as is appropriate for identifying medically accepted indications for drugs. Any such revision shall be done in a manner consistent with the process for revising compendia under section 1861(t)(2)(B).´´.
          (2) Effective Date.—
             The amendments made by this subsection shall apply to plan years beginning on or after January 1, 2009.
    (b) Conflicts of Interest.—
       Section 1861(t)(2)(B) of the Social Security Act (42 U.S.C. 1395x(t)(2)(B)) is amended by adding at the end the following new sentence: ``On and after January 1, 2010, no compendia may be included on the list of compendia under this subparagraph unless the compendia has a publicly transparent process for evaluating therapies and for identifying potential conflicts of interests.´´.

### Sec. 183. Contract with a Consensus-Based Entity Regarding Performance Measurement.

    (a) Contract.—
          (1) In General.—
             Part E of title XVIII of the Social Security Act (42 U.S.C. 1395x et seq.) is amended by inserting after section 1889 the following new section:

##### ``Sec. 1890. Contract with a Consensus-Based Entity Regarding Performance Measurement.

                (a) Contract.—
                   ``(1) In general.—For purposes of activities conducted under this Act, the Secretary shall identify and have in effect a contract with a consensus-based entity, such as the National Quality Forum, that meets the requirements described in subsection (c). Such contract shall provide that the entity will perform the duties described in subsection (b).
                   ``(2) Timing for first contract.—As soon as practicable after the date of the enactment of this subsection, the Secretary shall enter into the first contract under paragraph (1).
                   ``(3) Period of contract.—A contract under paragraph (1) shall be for a period of 4 years (except as may be renewed after a subsequent bidding process).
                   ``(4) Competitive procedures.—Competitive procedures (as defined in section 4(5) of the Office of Federal Procurement Policy Act (41 U.S.C. 403(5))) shall be used to enter into a contract under paragraph (1).
                ``(b) Duties.—The duties described in this subsection are the following:
                   ``(1) Priority setting process.—The entity shall synthesize evidence and convene key stakeholders to make recommendations, with respect to activities conducted under this Act, on an integrated national strategy and priorities for health care performance measurement in all applicable settings. In making such recommendations, the entity shall—
                      ``(A) ensure that priority is given to measures—
                         ``(i) that address the health care provided to patients with prevalent, high-cost chronic diseases;
                         ``(ii) with the greatest potential for improving the quality, efficiency, and patient-centeredness of health care; and
                         ``(iii) that may be implemented rapidly due to existing evidence, standards of care, or other reasons; and
                      ``(B) take into account measures that—
                         ``(i) may assist consumers and patients in making informed health care decisions;
                         ``(ii) address health disparities across groups and areas; and
                         ``(iii) address the continuum of care a patient receives, including services furnished by multiple health care providers or practitioners and across multiple settings.
                   ``(2) Endorsement of measures.—The entity shall provide for the endorsement of standardized health care performance measures. The endorsement process under the preceding sentence shall consider whether a measure—
                      ``(A) is evidence-based, reliable, valid, verifiable, relevant to enhanced health outcomes, actionable at the caregiver level, feasible to collect and report, and responsive to variations in patient characteristics, such as health status, language capabilities, race or ethnicity, and income level; and
                      ``(B) is consistent across types of health care providers, including hospitals and physicians.
                   ``(3) Maintenance of measures.—The entity shall establish and implement a process to ensure that measures endorsed under paragraph (2) are updated (or retired if obsolete) as new evidence is developed.
                   ``(4) Promotion of the development of electronic health records.—The entity shall promote the development and use of electronic health records that contain the functionality for automated collection, aggregation, and transmission of performance measurement information.
                   ``(5) Annual report to Congress and the Secretary; Secretarial publication and comment.—
                      ``(A) Annual report.—By not later than March 1 of each year (beginning with 2009), the entity shall submit to Congress and the Secretary a report containing a description of—
                         ``(i) the implementation of quality measurement initiatives under this Act and the coordination of such initiatives with quality initiatives implemented by other payers;
                         ``(ii) the recommendations made under paragraph (1); and
                         ``(iii) the performance by the entity of the duties required under the contract entered into with the Secretary under subsection (a).
                      ``(B) Secretarial review and publication of annual report.—Not later than 6 months after receiving a report under subparagraph (A) for a year, the Secretary shall—
                         ``(i) review such report; and
                         ``(ii) publish such report in the Federal Register, together with any comments of the Secretary on such report.
                ``(c) Requirements described.—The requirements described in this subsection are the following:
                   ``(1) Private nonprofit.—The entity is a private nonprofit entity governed by a board.
                   ``(2) Board membership.—The members of the board of the entity include—
                      ``(A) representatives of health plans and health care providers and practitioners or representatives of groups representing such health plans and health care providers and practitioners;
                      ``(B) health care consumers or representatives of groups representing health care consumers; and
                      ``(C) representatives of purchasers and employers or representatives of groups representing purchasers or employers.
                   ``(3) Entity membership.—The membership of the entity includes persons who have experience with—
                      ``(A) urban health care issues;
                      ``(B) safety net health care issues;
                      ``(C) rural and frontier health care issues; and
                      ``(D) health care quality and safety issues.
                   ``(4) Open and transparent.—With respect to matters related to the contract with the Secretary under subsection (a), the entity conducts its business in an open and transparent manner and provides the opportunity for public comment on its activities.
                   ``(5) Voluntary consensus standards setting organization.—The entity operates as a voluntary consensus standards setting organization as defined for purposes of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (Public Law 104-113) and Office of Management and Budget Revised Circular A–119 (published in the Federal Register on February 10, 1998).
                   ``(6) Experience.—The entity has at least 4 years of experience in establishing national consensus standards.
                   ``(7) Membership fees.—If the entity requires a membership fee for participation in the functions of the entity, such fees shall be reasonable and adjusted based on the capacity of the potential member to pay the fee. In no case shall membership fees pose a barrier to the participation of individuals or groups with low or nominal resources to participate in the functions of the entity.
                ``(d) Funding.—For purposes of carrying out this section, 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 such proportion as the Secretary determines appropriate), of $10,000,000 to the Centers for Medicare & Medicaid Services Program Management Account for each of fiscal years 2009 through 2012.´´.
          (2) Sense of the Senate.—
             It is the Sense of the Senate that the selection by the Secretary of Health and Human Services of an entity to contract with under section 1890(a) of the Social Security Act, as added by paragraph (1), should not be construed as diminishing the significant contributions of the Boards of Medicine, the quality alliances, and other clinical and technical experts to efforts to measure and improve the quality of health care services.
    (b) GAO Study and Reports on the Performance and Costs of the Consensus-based Entity Under the Contract.—
          (1) In General.—
             The Comptroller General of the United States shall conduct a study on—
                (A) the performance of the entity with a contract with the Secretary of Health and Human Services under section 1890(a) of the Social Security Act, as added by subsection (a), of its duties under such contract; and
                (B) the costs incurred by such entity in performing such duties.
          (2) Reports.—
             Not later than 18 months and 36 months after the effective date of the first contract entered into under such section 1890(a), the Comptroller General of the United States shall submit to Congress a report containing the results of the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.

### Sec. 184. Cost-Sharing for Clinical Trials.

    Section 1833 of the Social Security Act (42 U.S.C. 1395l), as amended by section 151(a), is amended by adding at the end the following new subsection:
          ``(w) Methods of payment.—The Secretary may develop alternative methods of payment for items and services provided under clinical trials and comparative effectiveness studies sponsored or supported by an agency of the Department of Health and Human Services, as determined by the Secretary, to those that would otherwise apply under this section, to the extent such alternative methods are necessary to preserve the scientific validity of such trials or studies, such as in the case where masking the identity of interventions from patients and investigators is necessary to comply with the particular trial or study design.´´.

### Sec. 185. Addressing Health Care Disparities.

    Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is amended by inserting after section 1808 the following new section:

##### ``Sec. 1809. Addressing Health Care Disparities.

          ``(a) Evaluating data collection approaches.—The Secretary shall evaluate approaches for the collection of data under this title, to be performed in conjunction with existing quality reporting requirements and programs under this title, that allow for the ongoing, accurate, and timely collection and evaluation of data on disparities in health care services and performance on the basis of race, ethnicity, and gender. In conducting such evaluation, the Secretary shall consider the following objectives:
             ``(1) Protecting patient privacy.
             ``(2) Minimizing the administrative burdens of data collection and reporting on providers and health plans participating under this title.
             ``(3) Improving Medicare program data on race, ethnicity, and gender.
          ``(b) Reports to congress.—
             ``(1) Report on evaluation.—Not later than 18 months after the date of the enactment of this section, the Secretary shall submit to Congress a report on the evaluation conducted under subsection (a). Such report shall, taking into consideration the results of such evaluation—
                ``(A) identify approaches (including defining methodologies) for identifying and collecting and evaluating data on health care disparities on the basis of race, ethnicity, and gender for the original Medicare fee-for-service program under parts A and B, the Medicare Advantage program under part C, and the Medicare prescription drug program under part D; and
                ``(B) include recommendations on the most effective strategies and approaches to reporting HEDIS quality measures as required under section 1852(e)(3) and other nationally recognized quality performance measures, as appropriate, on the basis of race, ethnicity, and gender.
             ``(2) Reports on data analyses.—Not later than 4 years after the date of the enactment of this section, and 4 years thereafter, the Secretary shall submit to Congress a report that includes recommendations for improving the identification of health care disparities for Medicare beneficiaries based on analyses of the data collected under subsection (c).
          ``(c) Implementing effective approaches.—Not later than 24 months after the date of the enactment of this section, the Secretary shall implement the approaches identified in the report submitted under subsection (b)(1) for the ongoing, accurate, and timely collection and evaluation of data on health care disparities on the basis of race, ethnicity, and gender.´´.

### Sec. 186. Demonstration to Improve Care to Previously Uninsured.

    (a) Establishment.—
       Within one year after the date of the enactment of this Act, the Secretary (in this section referred to as the ``Secretary´´) shall establish a demonstration project to determine the greatest needs and most effective methods of outreach to medicare beneficiaries who were previously uninsured.
    (b) Scope.—
       The demonstration shall be in no fewer than 10 sites, and shall include state health insurance assistance programs, community health centers, community-based organizations, community health workers, and other service providers under parts A, B, and C of title XVIII of the Social Security Act. Grantees that are plans operating under part C shall document that enrollees who were previously uninsured receive the ``Welcome to Medicare´´ physical exam.
    (c) Duration.—
       The Secretary shall conduct the demonstration project for a period of 2 years.
    (d) Report and Evaluation.—
       The Secretary shall conduct an evaluation of the demonstration and not later than 1 year after the completion of the project shall submit to Congress a report including the following:
          (1) An analysis of the effectiveness of outreach activities targeting beneficiaries who were previously uninsured, such as revising outreach and enrollment materials (including the potential for use of video information), providing one-on-one counseling, working with community health workers, and amending the Medicare and You handbook.
          (2) The effect of such outreach on beneficiary access to care, utilization of services, efficiency and cost-effectiveness of health care delivery, patient satisfaction, and select health outcomes.

### Sec. 187. Office of the Inspector General Report on Compliance With and Enforcement Of National Standards on Culturally and Linguistically Appropriate Services (CLAS) in Medicare.

    (a) Report.—
       Not later than two years after the date of the enactment of this Act, the Inspector General of the Department of Health and Human Services shall prepare and publish a report on—
          (1) the extent to which Medicare providers and plans are complying with the Office for Civil Rights’ Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons and the Office of Minority Health’s Culturally and Linguistically Appropriate Services Standards in health care; and
          (2) a description of the costs associated with or savings related to the provision of language services.
       Such report shall include recommendations on improving compliance with CLAS Standards and recommendations on improving enforcement of CLAS Standards.
    (b) Implementation.—
       Not later than one year after the date of publication of the report under subsection (a), the Department of Health and Human Services shall implement changes responsive to any deficiencies identified in the report.

### Sec. 188. Medicare Improvement Funding.

    (a) Medicare Improvement Fund.—
          (1) In General.—
             Subject to paragraph (2), title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is amended by adding at the end the following new section:

##### ``Sec. 1898. Medicare Improvement Fund.

                ``(a) Establishment.—
                   ``The Secretary shall establish under this title a Medicare Improvement Fund (in this section referred to as the ‘Fund’) which shall be available to the Secretary to make improvements under the original fee-for-service program under parts A and B for individuals entitled to, or enrolled for, benefits under part A or enrolled under part B.
                ``(b) Funding.—
                      ``(1) In general.—There shall be available to the Fund, for expenditures from the Fund for services furnished during fiscal years 2014 through 2017, $19,900,000,000.
                      ``(2) Payment from trust funds.—The amount specified under paragraph (1) shall be available to the Fund, as expenditures are made from the Fund, from the Federal Hospital Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund in such proportion as the Secretary determines appropriate.
                      ``(3) Funding limitation.—Amounts in the Fund shall be available in advance of appropriations but only if the total amount obligated from the Fund does not exceed the amount available to the Fund under paragraph (1). The Secretary may obligate funds from the Fund only if the Secretary determines (and the Chief Actuary of the Centers for Medicare & Medicaid Services and the appropriate budget officer certify) that there are available in the Fund sufficient amounts to cover all such obligations incurred consistent with the previous sentence.´´.
          (2) Contingency.—
                (A) In General.—
                   If there is enacted, before, on, or after the date of the enactment of this Act, a Supplemental Appropriations Act, 2008 that includes a provision providing for a Medicare Improvement Fund under a section 1898 of the Social Security Act, the alternative amendment described in subparagraph (B)—
                      (i) shall apply instead of the amendment made by paragraph (1); and
                      (ii) shall be executed after such provision in such Supplemental Appropriations Act.
                (B) Alternative Amendment Described.—
                   The alternative amendment described in this subparagraph is as follows: Section 1898(b)(1) of the Social Security Act, as added by the Supplemental Appropriations Act, 2008, is amended by inserting before the period at the end the following: `` and, in addition for services furnished during fiscal years 2014 through 2017, $19,900,000,000´´.
    (b) Implementation.—
       For purposes of carrying out the provisions of, and amendments made by, this title, in addition to any other amounts provided in such provisions and amendments, the Secretary of Health and Human Services shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under section 1817 of the Social Security Act (42 U.S.C. 1395i) and the Federal Supplementary Medical Insurance Trust Fund under section 1841 of such Act (42 U.S.C. 1395t), in the same proportion as the Secretary determines under section 1853(f) of such Act (42 U.S.C. 1395w–23(f)), of $140,000,000 to the Centers for Medicare & Medicaid Services Program Management Account for the period of fiscal years 2009 through 2013.

### Sec. 189. Inclusion of Medicare Providers and Suppliers in Federal Payment Levy and Administrative Offset Program.

    (a) In General.—
       Section 1874 of the Social Security Act (42 U.S.C. 1395kk) is amended by adding at the end the following new subsection:
          ``(d) Inclusion of Medicare provider and supplier payments in Federal Payment Levy Program.—
             ``(1) In general.—The Centers for Medicare & Medicaid Services shall take all necessary steps to participate in the Federal Payment Levy Program under section 6331(h) of the Internal Revenue Code of 1986 as soon as possible and shall ensure that—
                ``(A) at least 50 percent of all payments under parts A and B are processed through such program beginning within 1 year after the date of the enactment of this section;
                ``(B) at least 75 percent of all payments under parts A and B are processed through such program beginning within 2 years after such date; and
                ``(C) all payments under parts A and B are processed through such program beginning not later than September 30, 2011.
             ``(2) Assistance.—The Financial Management Service and the Internal Revenue Service shall provide assistance to the Centers for Medicare & Medicaid Services to ensure that all payments described in paragraph (1) are included in the Federal Payment Levy Program by the deadlines specified in that subsection.´´.
    (b) Application of Administrative Offset Provisions to Medicare Provider or Supplier Payments.—
       Section 3716 of title 31, United States Code, is amended—
          (1) by inserting ``the Department of Health and Human Services,´´ after ``United States Postal Service,´´ in subsection (c)(1)(A); and
          (2) by adding at the end of subsection (c)(3) the following new subparagraph:
             ``(D) This section shall apply to payments made after the date which is 90 days after the enactment of this subparagraph (or such earlier date as designated by the Secretary of Health and Human Services) with respect to claims or debts, and to amounts payable, under title XVIII of the Social Security Act.´´.
    (c) Effective Date.—
       The amendments made by this section shall take effect on the date of the enactment of this Act.