product or service under the Medicare program 
under title XVIII of the Social Security Act. 
SEC. 4. PROCESS FOR CERTAIN NATIONAL COVERAGE DE-
TERMINATIONS. 
(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 cov-
erage 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 cov-
erage for an item or service that— 
(A) is supported by current clinical prac-
tice guidelines— 
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(i) included in the National Guideline 
Clearinghouse maintained by the Agency 
for Healthcare Research and Quality; or 
(ii) maintained by a State medical so-
ciety; 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 Sec-
retary 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 evi-
dence 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 
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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 sub-
populations of beneficiaries (including 
men, women, racial and ethnic minori-
ties, the elderly, individuals with dis-
abilities, 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 clin-
ical and scientific evidence relating to the 
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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 mem-
bers, 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 sub-
committee convened under paragraph (3)(A) 
shall submit to the Administrator a public com-
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ment on the NCD that contains an evaluation 
of whether— 
(i) the NCD is appropriate based on 
the subcommittee’s activities under para-
graph (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 subpopula-
tions; or 
(iv) the NCD would adversely impact 
access to treatment options that are pri-
marily selected by patients, with their phy-
sicians, based on patient preference and 
quality of life criteria. 
(B) NCDS
THAT
PREVENT
ACCESS
TO 
CARE.—If MEDCAC determines that the pro-
posed 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 
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NCD that contains any restrictions on the coverage of 
products and services that were not included in the pro-
posed 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 ‘‘Adminis-
trator’’ means the Administrator of CMS. 
(2) CMS.—The term ‘‘CMS’’ means the Cen-
ters for Medicare & Medicaid Services. 
(3) MEDCAC.—The term ‘‘MEDCAC’’ means 
the Medicare Evidence Development & Coverage Ad-
visory 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, in-
jury, disease or its associated symptoms, impair-
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