Page:United States Statutes at Large Volume 117.djvu/2090

 PUBLIC LAW 108–173—DEC. 8, 2003

117 STAT. 2071

Sec. 1015. Funding start-up administrative costs for medicare reform. Sec. 1016. Health care infrastructure improvement program. TITLE XI—ACCESS TO AFFORDABLE PHARMACEUTICALS Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec.

1101. 1102. 1103. 1104.

Subtitle A—Access to Affordable Pharmaceuticals Thirty-month stay-of-effectiveness period. Forfeiture of 180-day exclusivity period. Bioavailability and bioequivalence. Conforming amendments.

1111. 1112. 1113. 1114. 1115. 1116. 1117. 1118.

Subtitle B—Federal Trade Commission Review Definitions. Notification of agreements. Filing deadlines. Disclosure exemption. Enforcement. Rulemaking. Savings clause. Effective date.

Subtitle C—Importation of Prescription Drugs Sec. 1121. Importation of prescription drugs. Sec. 1122. Study and report on importation of drugs. Sec. 1123. Study and report on trade in pharmaceuticals. TITLE XII—TAX INCENTIVES FOR HEALTH AND RETIREMENT SECURITY Sec. 1201. Health savings accounts. Sec. 1202. Exclusion from gross income of certain Federal subsidies for prescription drug plans. Sec. 1203. Exception to information reporting requirements related to certain health arrangements.

TITLE I—MEDICARE PRESCRIPTION DRUG BENEFIT SEC. 101. MEDICARE PRESCRIPTION DRUG BENEFIT.

(a) IN GENERAL.—Title XVIII is amended— (1) by redesignating part D as part E; and (2) by inserting after part C the following new part: ‘‘PART D—VOLUNTARY PRESCRIPTION DRUG BENEFIT PROGRAM ‘‘Subpart 1—Part D Eligible Individuals and Prescription Drug Benefits ‘‘ELIGIBILITY,

ENROLLMENT, AND INFORMATION

‘‘SEC. 1860D–1. (a) PROVISION OF QUALIFIED PRESCRIPTION DRUG COVERAGE THROUGH ENROLLMENT IN PLANS.— ‘‘(1) IN GENERAL.—Subject to the succeeding provisions of this part, each part D eligible individual (as defined in paragraph (3)(A)) is entitled to obtain qualified prescription drug coverage (described in section 1860D–2(a)) as follows: ‘‘(A) FEE-FOR-SERVICE ENROLLEES MAY RECEIVE COVERAGE THROUGH A PRESCRIPTION DRUG PLAN.—A part D eligible individual who is not enrolled in an MA plan may obtain qualified prescription drug coverage through enrollment in a prescription drug plan (as defined in section 1860D–41(a)(14)). ‘‘(B) MEDICARE ADVANTAGE ENROLLEES.—

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