text: 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.
target: Medicare Patient Safeguards Act of 2009 - Expresses the sense of Congress that: (1) efforts to make the Medicare program financially sustainable, including application of comparative effectiveness research, should not deprive patients of medically necessary care solely due to its cost or 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 Centers for Medicare and Medicaid Services (CMS) relies on adequate clinical expertise when the Administrator proposes to narrow coverage for a product or service under title XVIII (Medicare) of the Social Security Act.
  
  Establishes a process for the issuing of Medicare national coverage determinations by the Administrator. Enumerates prohibitions and conditions.
feat_title: 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.