I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medicare Patient Safe5 guards Act of 2009’’. 


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1 SEC. 2. FINDINGS. 

2 The Congress finds the following: 

3 (1) The 2009 Medicare Trustees Report esti4 mates that Medicare spending could grow from 3.2 

5 percent of the U.S. economy to 11.4 percent during 

6 the next 75 years and warns of the significant cost 

7 burden growth of this magnitude would place on 

8 workers, Medicare beneficiaries, and the Federal 

9 budget. 

10 (2) In 2009, Congress provided $1,150,000,000 

11 for comparative effectiveness research, including 

12 cost-effectiveness analysis. 

13 (3) The Medicare Payment and Advisory Com14 mission suggested that the Centers for Medicare & 

15 Medicaid Services use cost effectiveness analysis to 

16 look at groups of services used to treat specific ill17 nesses that have small differences in quality but 

18 large differences in cost. 

19 (4) MedPAC has reported concerns that the 

20 rigid use of cost effectiveness analysis might limit 

21 Medicare beneficiaries’ access to certain services, ra22 tion rather than promote appropriate care, slow in23 novation, and interfere with the practice of medicine. 

24 (5) MedPAC has listed methodological and re25 porting shortcomings of cost effectiveness analysis, 

26 including not using all available clinical evidence, not 


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1 sufficiently reporting on the extent to which the re2 sults are applicable to the general population, selec3 tively reporting results, and placing undue emphasis 

4 on certain results of such analysis. 

5 (6) While serving as the head of Congressional 

6 Budget Office, White House Budget director Peter 

7 Orszag said determining which treatment was most 

8 cost effective for a given population would involve 

9 placing a dollar value on an additional year of life. 

10 (7) While serving as the head of Congressional 

11 Budget Office, White House Budget director Peter 

12 Orszag suggested the possibility of limiting Medicare 

13 coverage for more effective but more expensive serv14 ices. 

15 (8) CMS recently described cost effectiveness 

16 analysis expertise as one of its most critical needs to 

17 Medicare Evidence Development & Coverage Advi18 sory Committee, which advises CMS on national cov19 erage determinations (NCDs). 

20 (9) CMS, through proposed rule making, has 

21 twice failed in attempts to formally incorporate cost 

22 effectiveness analysis into NCDs. 

23 (10) CMS officials report that the agency con24 siders potential cost savings before deciding to make 


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1 changes to a NCD that narrows coverage under the 

2 Medicare program. 

3 (11) AARP has stated that comparative effec4 tiveness research is intended to help consumers and 

5 providers determine the best treatment, not just the 

6 least costly treatment. AARP warned that this infor7 mation from comparative effectiveness research 

8 should not be used as a means to deny individuals 

9 access to appropriate therapeutic options. 

10 (12) The Congressional Black Caucus, focusing 

11 in particular on the exacerbating of health inequities 

12 across subpopulation groups, expressed concerns 

13 that comparative effectiveness research should not 

14 be used as rationale for limiting care to the care 

15 that works best for the average patient, rather than 

16 providing coverage for the care that works best for 

17 each individual patient. 

18 (13) Congressional New Democrats— 

19 (A) argued that any application of com20 parative effectiveness research must protect 

21 against the use of this research to deny access 

22 to care solely based on cost; and 

23 (B) urged Congress to ensure that clinical 

24 effectiveness and medical outcomes are the 


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1 focus of comparative effectiveness research 

2 funding.

3 (14) The American Heart Association— 

4 (A) urges Congress to include patient safe5 guards in legislation to prevent the misuse of 

6 cost effectiveness analysis; and 

7 (B) argues that the primary focus of com8 parative effectiveness research should be opti9 mizing clinical outcomes and value for patients 

10 and society and not for the purpose of mini11 mizing costs. 

12 SEC. 3. SENSE OF CONGRESS. 

13 It is the sense of the Congress that— 

14 (1) efforts to make the Medicare program fi15 nancially sustainable, including the application of 

16 comparative effectiveness research, should not— 

17 (A) deprive patients of medically necessary 

18 care solely due to the cost of such care; or 

19 (B) limit access to needed health care serv20 ices due to a patient’s age, gender, ethnicity, or 

21 disability status; and 

22 (2) Congress should protect patients’ access to 

23 needed care by ensuring that the Administrator of 

24 CMS relies on adequate clinical expertise when the 

25 Administrator proposes to narrow coverage for a 


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1 product or service under the Medicare program 

2 under title XVIII of the Social Security Act. 

3 SEC. 4. PROCESS FOR CERTAIN NATIONAL COVERAGE DE4 TERMINATIONS. 

5 (a) REQUIREMENTS FOR THE ISSUANCE OF CERTAIN

6 MEDICARE NATIONAL COVERAGE DETERMINATIONS.— 

7 Unless all of the conditions under subsection (b) are met, 

8 the Administrator may not issue a final national coverage 

9 determination (referred to in this Act as a NCD)— 

10 (1) if the NCD restricts local or national cov11 erage for an item or service that, before the date of 

12 the issuance of such NCD, was routinely covered 

13 under the Medicare program under title XVIII of 

14 the Social Security Act; 

15 (2) if the NCD would result in significant cost 

16 savings for the Medicare program; 

17 (3) if there is controversy in the available peer18 reviewed medical and scientific literature about the 

19 evidence supporting the NCD; 

20 (4) if the NCD restricts local or national cov21 erage for an item or service that— 

22 (A) is supported by current clinical prac23 tice guidelines— 


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1 (i) included in the National Guideline 

2 Clearinghouse maintained by the Agency 

3 for Healthcare Research and Quality; or 

4 (ii) maintained by a State medical so5 ciety; or 

6 (B) is endorsed by the National Quality 

7 Forum or by another national organization that 

8 evaluates voluntary consensus-based provides 

9 quality measures and is designated by the Sec10 retary for purposes of making an endorsement 

11 under this subparagraph; or 

12 (5) if the Administrator determines that— 

13 (A) significant differences in opinion exist 

14 among experts concerning— 

15 (i) what evidence should be reviewed 

16 in developing the NCD; or 

17 (ii) how data should be interpreted for 

18 purposes of developing the NCD; and 

19 (B) an independent analysis of the evi20 dence and data analysis would be valuable in 

21 developing the final NCD. 

22 (b) REQUIRED CONDITIONS.—The conditions under 

23 this subsection are as follows: 

24 (1) REQUEST FOR REVIEW.—Before the start 

25 of the public comment period for a proposed NCD 


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1 that contains all the restrictions on the coverage of 

2 products and services included in the final NCD, the 

3 Administrator makes a formal request to MEDCAC 

4 for a review of the scientific and clinical evidence 

5 supporting and opposing the NCD. 

6 (2) MEDCAC REVIEW SUBCOMMITTEE.— 

7 (A) IN GENERAL.—MEDCAC convenes a 

8 subcommittee to— 

9 (i) review the evidence supporting the 

10 proposed NCD (including clinical practice 

11 guidelines published by medical specialty 

12 societies), taking into account— 

13 (I) the evidence related to sub14 populations of beneficiaries (including 

15 men, women, racial and ethnic minori16 ties, the elderly, individuals with dis17 abilities, and individuals with genetic 

18 variations); and 

19 (II) the extent to which patient 

20 preference is a factor in the use of the 

21 item or service that is the subject of 

22 the NCD; 

23 (ii) conduct an evaluation of the clin24 ical and scientific evidence relating to the 


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1 clinical benefits and risks of a technology 

2 affected by such NCD; and 

3 (iii) determine if the NCD will limit 

4 the access of Medicare beneficiaries to 

5 medically necessary care. 

6 (B) MEMBERSHIP.—The subcommittee 

7 under subparagraph (A) shall have 15 mem8 bers, each of whom— 

9 (i) shall be a clinical expert in the 

10 medical specialty or specialties that are 

11 most relevant to the topic of the NCD; and 

12 (ii) to the extent feasible, shall have 

13 expertise in the development of clinical 

14 practice guidelines. 

15 (C) OUTSIDE EXPERTS ALLOWED.— 

16 MEDCAC may include individuals who are not 

17 members of MEDCAC in the membership of 

18 the subcommittee convened under subparagraph 

19 (A). 

20 (3) SUBCOMMITTEE COMMENT.— 

21 (A) IN GENERAL.—Not later than the last 

22 day of the period under paragraph (1), the sub23 committee convened under paragraph (3)(A) 

24 shall submit to the Administrator a public comVerDate Nov 24 2008 23:26 Jul 29, 2009 Jkt 079200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3361.IH H3361

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1 ment on the NCD that contains an evaluation 

2 of whether— 

3 (i) the NCD is appropriate based on 

4 the subcommittee’s activities under para5 graph (2)(A); 

6 (ii) the NCD is consistent with clinical 

7 guidelines; 

8 (iii) the NCD would adversely impact 

9 the access of subpopulations to items or 

10 services which may benefit such subpopula11 tions; or 

12 (iv) the NCD would adversely impact 

13 access to treatment options that are pri14 marily selected by patients, with their phy15 sicians, based on patient preference and 

16 quality of life criteria. 

17 (B) NCDS THAT PREVENT ACCESS TO

18 CARE.—If MEDCAC determines that the pro19 posed NCD could prevent Medicare patients 

20 from receiving medically necessary care, the 

21 MEDCAC panel shall include in such public 

22 comment a recommendation that the proposed 

23 NCD not be issued as a final NCD. 

24 (c) RESTRICTION ON ADDITIONAL LIMITATION ON

25 COVERAGE.—The Administrator may not issue a final 


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1 NCD that contains any restrictions on the coverage of 

2 products and services that were not included in the pro3 posed NCD reviewed under subsection (b). 

4 (d) CONSTRUCTION.—Nothing in this Act shall be 

5 construed as preventing a Medicare beneficiary from using 

6 private funds to purchase supplemental health insurance 

7 coverage or to directly purchase medically necessary care. 

8 SEC. 5. DEFINITIONS. 

9 For purposes of this Act: 

10 (1) ADMINISTRATOR.—The term ‘‘Adminis11 trator’’ means the Administrator of CMS. 

12 (2) CMS.—The term ‘‘CMS’’ means the Cen13 ters for Medicare & Medicaid Services. 

14 (3) MEDCAC.—The term ‘‘MEDCAC’’ means 

15 the Medicare Evidence Development & Coverage Ad16 visory Committee established by the Secretary of 

17 Health and Human Services pursuant to section 222 

18 of the Public Health Service Act. 

19 (4) MEDICALLY NECESSARY SERVICES.—The 

20 term ‘‘medically necessary care’’ means health care 

21 services or products that a prudent physician would 

22 provide to a patient for the purpose of preventing, 

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1 ments or functional limitations in a manner that 

2 is— 

3 (A) in accordance with generally accepted 

4 standards of medical practice; 

5 (B) clinically appropriate in terms of type, 

6 frequency, extent, site and duration; and 

7 (C) not primarily for the convenience of 

8 the patient, physician, or other health care pro9 vider. 

10 (5) MEDPAC.—The term ‘‘MedPAC’’ means 

11 the Medicare Payment Advisory Commission estab12 lished under Section 1805 of the Social Security Act. 

13 (6) NATIONAL COVERAGE DETERMINATION.— 

14 The term ‘‘national coverage determination’’ has the 

15 meaning given such term in section 1869(f)(1)(B) of 

16 the Social Security Act. 

Æ 


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