[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3361 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 3361

     To provide a process for public comment and Medicare Evidence 
 Development & Coverage Advisory Committee review of certain Medicare 
       national coverage determinations, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 28, 2009

    Mr. Boustany (for himself, Mr. Roe of Tennessee, Mr. Gingrey of 
Georgia, Mr. Fleming, Mr. Olson, Mr. Linder, Mr. Reichert, Mr. Boozman, 
and Mr. Alexander) introduced the following bill; which was referred to 
the Committee on Energy and Commerce, and in addition to the Committee 
 on Ways and Means, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
     To provide a process for public comment and Medicare Evidence 
 Development & Coverage Advisory Committee review of certain Medicare 
       national coverage determinations, 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.

    This Act may be cited as the ``Medicare Patient Safeguards Act of 
2009''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) The 2009 Medicare Trustees Report estimates that 
        Medicare spending could grow from 3.2 percent of the U.S. 
        economy to 11.4 percent during the next 75 years and warns of 
        the significant cost burden growth of this magnitude would 
        place on workers, Medicare beneficiaries, and the Federal 
        budget.
            (2) In 2009, Congress provided $1,150,000,000 for 
        comparative effectiveness research, including cost-
        effectiveness analysis.
            (3) The Medicare Payment and Advisory Commission suggested 
        that the Centers for Medicare & Medicaid Services use cost 
        effectiveness analysis to look at groups of services used to 
        treat specific illnesses that have small differences in quality 
        but large differences in cost.
            (4) MedPAC has reported concerns that the rigid use of cost 
        effectiveness analysis might limit Medicare beneficiaries' 
        access to certain services, ration rather than promote 
        appropriate care, slow innovation, and interfere with the 
        practice of medicine.
            (5) MedPAC has listed methodological and reporting 
        shortcomings of cost effectiveness analysis, including not 
        using all available clinical evidence, not sufficiently 
        reporting on the extent to which the results are applicable to 
        the general population, selectively reporting results, and 
        placing undue emphasis on certain results of such analysis.
            (6) While serving as the head of Congressional Budget 
        Office, White House Budget director Peter Orszag said 
        determining which treatment was most cost effective for a given 
        population would involve placing a dollar value on an 
        additional year of life.
            (7) While serving as the head of Congressional Budget 
        Office, White House Budget director Peter Orszag suggested the 
        possibility of limiting Medicare coverage for more effective 
        but more expensive services.
            (8) CMS recently described cost effectiveness analysis 
        expertise as one of its most critical needs to Medicare 
        Evidence Development & Coverage Advisory Committee, which 
        advises CMS on national coverage determinations (NCDs).
            (9) CMS, through proposed rule making, has twice failed in 
        attempts to formally incorporate cost effectiveness analysis 
        into NCDs.
            (10) CMS officials report that the agency considers 
        potential cost savings before deciding to make changes to a NCD 
        that narrows coverage under the Medicare program.
            (11) AARP has stated that comparative effectiveness 
        research is intended to help consumers and providers determine 
        the best treatment, not just the least costly treatment. AARP 
        warned that this information from comparative effectiveness 
        research should not be used as a means to deny individuals 
        access to appropriate therapeutic options.
            (12) The Congressional Black Caucus, focusing in particular 
        on the exacerbating of health inequities across subpopulation 
        groups, expressed concerns that comparative effectiveness 
        research should not be used as rationale for limiting care to 
        the care that works best for the average patient, rather than 
        providing coverage for the care that works best for each 
        individual patient.
            (13) Congressional New Democrats--
                    (A) argued that any application of comparative 
                effectiveness research must protect against the use of 
                this research to deny access to care solely based on 
                cost; and
                    (B) urged Congress to ensure that clinical 
                effectiveness and medical outcomes are the focus of 
                comparative effectiveness research funding.  
            (14) The American Heart Association--
                    (A) urges Congress to include patient safeguards in 
                legislation to prevent the misuse of cost effectiveness 
                analysis; and
                    (B) argues that the primary focus of comparative 
                effectiveness research should be optimizing clinical 
                outcomes and value for patients and society and not for 
                the purpose of minimizing costs.

SEC. 3. SENSE OF CONGRESS.

    It is the sense of the Congress that--
            (1) efforts to make the Medicare program financially 
        sustainable, including the application of comparative 
        effectiveness research, should not--
                    (A) deprive patients of medically necessary care 
                solely due to the cost of such care; or
                    (B) limit access to needed health care services due 
                to a patient's age, gender, ethnicity, or disability 
                status; and
            (2) Congress should protect patients' access to needed care 
        by ensuring that the Administrator of CMS relies on adequate 
        clinical expertise when the Administrator proposes to narrow 
        coverage for a product or service under the Medicare program 
        under title XVIII of the Social Security Act.

SEC. 4. PROCESS FOR CERTAIN NATIONAL COVERAGE DETERMINATIONS.

    (a) Requirements for the Issuance of Certain Medicare National 
Coverage Determinations.--Unless all of the conditions under subsection 
(b) are met, the Administrator may not issue a final national coverage 
determination (referred to in this Act as a NCD)--
            (1) if the NCD restricts local or national coverage for an 
        item or service that, before the date of the issuance of such 
        NCD, was routinely covered under the Medicare program under 
        title XVIII of the Social Security Act;
            (2) if the NCD would result in significant cost savings for 
        the Medicare program;
            (3) if there is controversy in the available peer-reviewed 
        medical and scientific literature about the evidence supporting 
        the NCD;
            (4) if the NCD restricts local or national coverage for an 
        item or service that--
                    (A) is supported by current clinical practice 
                guidelines--
                            (i) included in the National Guideline 
                        Clearinghouse maintained by the Agency for 
                        Healthcare Research and Quality; or
                            (ii) maintained by a State medical society; 
                        or
                    (B) is endorsed by the National Quality Forum or by 
                another national organization that evaluates voluntary 
                consensus-based provides quality measures and is 
                designated by the Secretary for purposes of making an 
                endorsement under this subparagraph; or
            (5) if the Administrator determines that--
                    (A) significant differences in opinion exist among 
                experts concerning--
                            (i) what evidence should be reviewed in 
                        developing the NCD; or
                            (ii) how data should be interpreted for 
                        purposes of developing the NCD; and
                    (B) an independent analysis of the evidence and 
                data analysis would be valuable in developing the final 
                NCD.
    (b) Required Conditions.--The conditions under this subsection are 
as follows:
            (1) Request for review.--Before the start of the public 
        comment period for a proposed NCD that contains all the 
        restrictions on the coverage of products and services included 
        in the final NCD, the Administrator makes a formal request to 
        MEDCAC for a review of the scientific and clinical evidence 
        supporting and opposing the NCD.
            (2) MEDCAC review subcommittee.--
                    (A) In general.--MEDCAC convenes a subcommittee 
                to--
                            (i) review the evidence supporting the 
                        proposed NCD (including clinical practice 
                        guidelines published by medical specialty 
                        societies), taking into account--
                                    (I) the evidence related to 
                                subpopulations of beneficiaries 
                                (including men, women, racial and 
                                ethnic minorities, the elderly, 
                                individuals with disabilities, and 
                                individuals with genetic variations); 
                                and
                                    (II) the extent to which patient 
                                preference is a factor in the use of 
                                the item or service that is the subject 
                                of the NCD;
                            (ii) conduct an evaluation of the clinical 
                        and scientific evidence relating to the 
                        clinical benefits and risks of a technology 
                        affected by such NCD; and
                            (iii) determine if the NCD will limit the 
                        access of Medicare beneficiaries to medically 
                        necessary care.
                    (B) Membership.--The subcommittee under 
                subparagraph (A) shall have 15 members, each of whom--
                            (i) shall be a clinical expert in the 
                        medical specialty or specialties that are most 
                        relevant to the topic of the NCD; and
                            (ii) to the extent feasible, shall have 
                        expertise in the development of clinical 
                        practice guidelines.
                    (C) Outside experts allowed.--MEDCAC may include 
                individuals who are not members of MEDCAC in the 
                membership of the subcommittee convened under 
                subparagraph (A).
            (3) Subcommittee comment.--
                    (A) In general.--Not later than the last day of the 
                period under paragraph (1), the subcommittee convened 
                under paragraph (3)(A) shall submit to the 
                Administrator a public comment on the NCD that contains 
                an evaluation of whether--
                            (i) the NCD is appropriate based on the 
                        subcommittee's activities under paragraph 
                        (2)(A);
                            (ii) the NCD is consistent with clinical 
                        guidelines;
                            (iii) the NCD would adversely impact the 
                        access of subpopulations to items or services 
                        which may benefit such subpopulations; or
                            (iv) the NCD would adversely impact access 
                        to treatment options that are primarily 
                        selected by patients, with their physicians, 
                        based on patient preference and quality of life 
                        criteria.
                    (B) Ncds that prevent access to care.--If MEDCAC 
                determines that the proposed NCD could prevent Medicare 
                patients from receiving medically necessary care, the 
                MEDCAC panel shall include in such public comment a 
                recommendation that the proposed NCD not be issued as a 
                final NCD.
    (c) Restriction on Additional Limitation on Coverage.--The 
Administrator may not issue a final NCD that contains any restrictions 
on the coverage of products and services that were not included in the 
proposed NCD reviewed under subsection (b).
    (d) Construction.--Nothing in this Act shall be construed as 
preventing a Medicare beneficiary from using private funds to purchase 
supplemental health insurance coverage or to directly purchase 
medically necessary care.

SEC. 5. DEFINITIONS.

    For purposes of this Act:
            (1) Administrator.--The term ``Administrator'' means the 
        Administrator of CMS.
            (2) CMS.--The term ``CMS'' means the Centers for Medicare & 
        Medicaid Services.
            (3) MEDCAC.--The term ``MEDCAC'' means the Medicare 
        Evidence Development & Coverage Advisory Committee established 
        by the Secretary of Health and Human Services pursuant to 
        section 222 of the Public Health Service Act.
            (4) Medically necessary services.--The term ``medically 
        necessary care'' means health care services or products that a 
        prudent physician would provide to a patient for the purpose of 
        preventing, diagnosing, treating or rehabilitating an illness, 
        injury, disease or its associated symptoms, impairments or 
        functional limitations in a manner that is--
                    (A) in accordance with generally accepted standards 
                of medical practice;
                    (B) clinically appropriate in terms of type, 
                frequency, extent, site and duration; and
                    (C) not primarily for the convenience of the 
                patient, physician, or other health care provider.
            (5) MedPAC.--The term ``MedPAC'' means the Medicare Payment 
        Advisory Commission established under Section 1805 of the 
        Social Security Act.
            (6) National coverage determination.--The term ``national 
        coverage determination'' has the meaning given such term in 
        section 1869(f)(1)(B) of the Social Security Act.
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