determinations denying Medicare prescription drug cov-
erage. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. CONTINUITY OF MEDICARE PRESCRIPTION 
DRUG COVERAGE FOR FULL-BENEFIT DUAL 
ELIGIBLE INDIVIDUALS. 
(a) IN GENERAL.—Section 1860D–2(a) of the Social 
Security Act (42 U.S.C. 1395w–102(a)) is amended— 
(1) in paragraph (1), by inserting ‘‘subject to 
paragraph (6),’’ after ‘‘part C’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(6) CONTINUATION OF MEDICARE COVERAGE 
FOR
CERTAIN
PRESCRIPTIONS
FOR
FULL-BENEFIT 
DUAL ELIGIBLE INDIVIDUALS.—In the case of an in-
dividual who, as of the date the individual is first 
enrolled under a prescription drug plan under this 
part (or an MA–PD plan under part C), is a full- 
benefit dual eligible individual and is being provided 
medical assistance for a covered part D drug under 
title XIX, qualified prescription drug coverage must 
include coverage for such drug unless a prescribing 
physician certifies that the coverage of such drug is 
not medically necessary, regardless of whether the 
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individual subsequently remains a full-benefit dual 
eligible individual.’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall be effective as if included in the enact-
ment of Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (Public Law 108–173). 
SEC. 2. MEDICARE PRESCRIPTION DRUG COVERAGE OF 
BENZODIAZEPINES. 
(a) IN GENERAL.—Section 1860D–2(e)(2)(A) of the 
Social Security Act (42 U.S.C. 1395w–112(e)(2)(A)) is 
amended by inserting after ‘‘agents)’’ the following: ‘‘and 
other than subparagraph (J) of such section (relating to 
benzodiazepines)’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall be effective as if included in the enact-
ment of Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (Public Law 108–173). 
SEC. 3. PERMITTING STATE MEDICAID PROGRAMS TO 
COVER MEDICARE PRESCRIPTION DRUG CO-
PAYMENTS FOR FULL-BENEFIT DUAL ELIGI-
BLE INDIVIDUALS. 
(a) IN GENERAL.—Section 1935(d) of the Social Se-
curity Act (42 U.S.C. 1396u–5(d)) is amended by adding 
at the end the following new paragraph: 
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‘‘(3) OPTIONAL COVERAGE OF MEDICARE PRE-
SCRIPTION
DRUG
COST-SHARING.—Notwithstanding 
paragraph (1), a State may, at its option, provide 
medical assistance under the plan under this title for 
the deductible and cost-sharing imposed under a 
prescription drug plan (or an MA–PD plan) for full- 
benefit dual eligible individuals and payment shall be 
available under section 1903(a) with respect to such 
assistance provided.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall be effective as if included in the enact-
ment of Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (Public Law 108–173). 
SEC. 4. MEDICARE COVERAGE OF OFF-LABEL USES OF PRE-
SCRIPTION DRUGS AND BIOLOGICALS. 
(a) IN GENERAL.—Section 1860D–2(e) of the Social 
Security Act (42 U.S.C. 1395w–102(e)) is amended at the 
end by adding the following new paragraph: 
‘‘(4) RULE OF CONSTRUCTION.—Nothing in this sub-
section shall be construed as excluding from the definition 
of the term ‘covered part D drug’— 
‘‘(A) a drug described in paragraph (1)(A) on 
the sole basis that such drug is prescribed by a phy-
sician for a use other than a use included in the la-
beling of such drug pursuant to the approval of the 
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safety and effectiveness of such drug as a prescrip-
tion drug under section 505 or 507 of the Federal 
Food, Drug, and Cosmetic Act or approval of such 
drug under section 505(j) of such Act; or 
‘‘(B) a biological product described in para-
graph (1)(B) on the sole basis that such product is 
prescribed by a physician for a use other than a use 
included in the labeling of such product pursuant to 
the licensure of such product under section 351 of 
the Public Health Service Act; 
even if the unlabeled use of the drug or product is not 
included in a standard clinical reference compendia used 
by clinicians for purposes of providing guidance to such 
clinicians with respect to unlabeled uses of such a drug 
or product.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall be effective as if included in the enact-
ment of Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (Public Law 108–173). 
SEC. 5. AUTHORIZATION FOR SECRETARY OF HEALTH AND 
HUMAN SERVICES TO WAIVE DENIAL OF PRE-
SCRIPTION DRUG COVERAGE. 
(a) IN GENERAL.—Section 1860D–4(h) of the Social 
Security Act (42 U.S.C. 1395w–104(h)) is amended at the 
end by adding the following new paragraph: 
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‘‘(4) AUTHORIZATION FOR SECRETARY TO WAIVE 
DENIAL OF PRESCRIPTION DRUG COVERAGE.—After a 
part D eligible individual has exhausted all rights of such 
individual under this subsection and subsection (g), with 
respect to a determination made under this subsection or 
subsection (g) for a prescription drug plan not to provide 
for coverage of a covered part D drug (or a determination 
related to the application of tiered cost-sharing described 
in subsection (g)(2)), the individual may apply to the Sec-
retary for a waiver that requires the prescription drug 
plan to provide for such coverage (or provide for an excep-
tion to the structure of such tiered cost-sharing). Upon 
receipt of such application, the Secretary may grant such 
waiver if the prescribing physician certifies that the cov-
erage of such prescription drug is medically necessary with 
respect to the individual.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to determinations made on or 
after the date of the enactment of this Act. 
Æ 
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