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S. 800 (is) To provide for post-conviction DNA testing, to establish a competent counsel grant program, and for other purposes. [Introduced in Senate] ...
108th CONGRESS 1st Session S. 7 To amend title XVIII of the Social Security Act to provide coverage of outpatient prescription drugs under the medicare program and to amend the Federal Food, Drug, and Cosmetic Act to provide greater access to affordable pharmaceuticals, and for other purposes. _______________________________________________________________________ IN THE SENATE OF THE UNITED STATES January 7, 2003 Mr. Daschle (for himself, Mr. Rockefeller, Ms. Stabenow, Mr. Schumer, Mr. Kennedy, Mrs. Clinton, Mr. Akaka, Mr. Corzine, Mr. Durbin, Ms. Mikulski, Mr. Leahy, Mr. Levin, Mr. Johnson, Mr. Reed, Mr. Sarbanes, Mr. Dayton, Mr. Lautenberg, and Mr. Reid) introduced the following bill; which was read twice and referred to the Committee on Finance _______________________________________________________________________ A BILL To amend title XVIII of the Social Security Act to provide coverage of outpatient prescription drugs under the medicare program and to amend the Federal Food, Drug, and Cosmetic Act to provide greater access to affordable pharmaceuticals, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE; TABLE OF CONTENTS. (a) Short Title.--This title may be cited as the ``Prescription Drug Benefit and Cost Containment Act of 2003''. (b) Table of Contents.--The table of contents of this title is as follows: Sec. 1. Short title; table of contents. Sec. 2. Findings. TITLE I--MEDICARE OUTPATIENT PRESCRIPTION DRUG BENEFIT PROGRAM Sec. 101. Medicare outpatient prescription drug benefit program. ``Part D--Outpatient Prescription Drug Benefit Program ``Sec. 1860. Definitions. ``Sec. 1860A. Establishment of outpatient prescription drug benefit program. ``Sec. 1860B. Enrollment under program. ``Sec. 1860C. Enrollment in a plan. ``Sec. 1860D. Providing information to beneficiaries. ``Sec. 1860E. Premiums. ``Sec. 1860F. Outpatient prescription drug benefits. ``Sec. 1860G. Entities eligible to provide outpatient drug benefit. ``Sec. 1860H. Minimum standards for eligible entities. ``Sec. 1860I. Payments. ``Sec. 1860J. Employer incentive program for employment-based retiree drug coverage. ``Sec. 1860K. Prescription Drug Account in the Federal Supplementary Medical Insurance Trust Fund. ``Sec. 1860L. Medicare Prescription Drug Advisory Committee.''. Sec. 102. Part D benefits under Medicare+Choice plans. Sec. 103. Additional assistance for low-income beneficiaries. Sec. 104. Medigap revisions. Sec. 105. Coverage of immunosuppressive drugs for all medicare beneficiaries under part B. Sec. 106. HHS study and report on uniform pharmacy benefit cards. Sec. 107. Expansion of membership and duties of Medicare Payment Advisory Commission (MedPAC). TITLE II--PRESCRIPTION DRUG COST CONTAINMENT AND QUALITY ASSURANCE Sec. 201. Filing of patent information with the Food and Drug Administration. Sec. 202. Limitation of 30-month stay to certain patents. Sec. 203. Exclusivity for accelerated generic drug applicants. Sec. 204. Fair treatment for innovators. Sec. 205. Bioequivalence. Sec. 206. Clarification of State authority relating to medicaid drug rebate agreements. Sec. 207. Importation of prescription drugs. Sec. 208. Pediatric labeling of drugs and biological products. Sec. 209. Report. Sec. 210. Conforming and technical amendments. SEC. 2. FINDINGS. Congress makes the following findings: (1) Prescription drug coverage was not a standard part of health insurance when the medicare program under title XVIII of the Social Security Act was enacted in 1965. Since 1965, however, drug coverage has become a key component of most private and public health insurance coverage, except for the medicare program. (2) At least \2/3\ of medicare beneficiaries have unreliable, inadequate, or no drug coverage at all. (3) Seniors who do not have drug coverage typically pay 15 percent more for prescription drugs than individuals who have such coverage. (4) The number of private firms offering retiree health coverage is declining. (5) The premiums for medicare supplemental policies (medigap policies) that provide prescription drug coverage are too expensive for most medicare beneficiaries and are highest for older senior citizens who need prescription drug coverage the most and typically have the lowest incomes. (6) All medicare beneficiaries should have access to a voluntary, reliable, affordable outpatient drug benefit as part of the medicare program that assists with the high cost of prescription drugs and protects them against excessive out-of- pocket costs. (7) Generic pharmaceuticals are approved by the Food and Drug Administration on the basis of scientific testing and other information establishing that pharmaceuticals are therapeutically equivalent to brand-name pharmaceuticals, ensuring consumers a safe, efficacious, and cost-effective alternative to brand-name innovator pharmaceuticals. (8) The Congressional Budget Office estimates that-- (A) the use of generic pharmaceuticals for brand- name pharmaceuticals could save purchasers of pharmaceuticals between $8,000,000,000 and $10,000,000,000 each year; and (B) generic pharmaceuticals cost between 25 percent and 60 percent less than brand-name pharmaceuticals, resulting in an estimated average savings of $15 to $30 on each prescription. (9) Expanding access to generic pharmaceuticals can help consumers, especially senior citizens and the uninsured, have access to more affordable prescription drugs. TITLE I--MEDICARE OUTPATIENT PRESCRIPTION DRUG BENEFIT PROGRAM SEC. 101. MEDICARE OUTPATIENT PRESCRIPTION DRUG BENEFIT PROGRAM. (a) Establishment.--Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is amended by redesignating part D as part E and by inserting after part C the following new part: ``Part D--Outpatient Prescription Drug Benefit Program ``definitions ``Sec. 1860. In this part: ``(1) Covered outpatient drug.-- ``(A) In general.--Except as provided in subparagraph (B), the term `covered outpatient drug' means any of the following products: ``(i) A drug which may be dispensed only upon prescription, and-- ``(I) which is approved for safety and effectiveness as a prescription drug under section 505 of the Federal Food, Drug, and Cosmetic Act; ``(II)(aa) which was commercially used or sold in the United States before the date of enactment of the Drug Amendments of 1962 or which is identical, similar, or related (within the meaning of section 310.6(b)(1) of title 21 of the Code of Federal Regulations) to such a drug, and (bb) which has not been the subject of a final determination by the Secretary that it is a `new drug' (within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act) or an action brought by the Secretary under section 301, 302(a), or 304(a) of such Act to enforce section 502(f) or 505(a) of such Act; or ``(III)(aa) which is described in section 107(c)(3) of the Drug Amendments of 1962 and for which the Secretary has determined there is a compelling justification for its medical need, or is identical, similar, or related (within the meaning of section 310.6(b)(1) of title 21 of the Code of Federal Regulations) to such a drug, and (bb) for which the Secretary has not issued a notice of an opportunity for a hearing under section 505(e) of the Federal Food, Drug, and Cosmetic Act on a proposed order of the Secretary to withdraw approval of an application for such drug under such section because the Secretary has determined that the drug is less than effective for all conditions of use prescribed, recommended, or suggested in its labeling. ``(ii) A biological product which-- ``(I) may only be dispensed upon prescription; ``(II) is licensed under section 351 of the Public Health Service Act; and ``(III) is produced at an establishment licensed under such section to produce such product. ``(iii) Insulin approved under appropriate Federal law, including needles and syringes for the administration of such insulin. ``(iv) A prescribed drug or biological product that would meet the requirements of clause (i) or (ii) except that it is available over-the-counter in addition to being available upon prescription. ``(B) Exclusion.--The term `covered outpatient drug' does not include any product-- ``(i) except as provided in subparagraph (A)(iv), which may be distributed to individuals without a prescription; ``(ii) for which payment is available under part A or B or would be available under part B but for the application of a deductible under such part (unless payment for such product is not available because benefits under part A or B have been exhausted), determined, except as provided in subparagraph (C), without regard to whether the beneficiary involved is entitled to benefits under part A or enrolled under part B; or ``(iii) except for agents used to promote smoking cessation and agents used for the treatment of obesity, for which coverage may be excluded or restricted under section 1927(d)(2). ``(2) Eligible beneficiary.--The term `eligible beneficiary' means an individual that is entitled to benefits under part A or enrolled under part B. ``(3) Eligible entity.--The term `eligible entity' means any entity that the Secretary determines to be appropriate to provide eligible beneficiaries with covered outpatient drugs under a plan under this part, including-- ``(A) a pharmacy benefit management company; ``(B) a retail pharmacy delivery system; ``(C) a health plan or insurer; ``(D) a State (through mechanisms established under a State plan under title XIX or under a State pharmaceutical assistance program); ``(E) any other entity approved by the Secretary; or ``(F) any combination of the entities described in subparagraphs (A) through (E) if the Secretary determines that such combination-- ``(i) increases the scope or efficiency of the provision of benefits under this part; and ``(ii) is not anticompetitive. ``(4) Medicare+choice organization; medicare+choice plan.-- The terms `Medicare+Choice organization' and `Medicare+Choice plan' have the meanings given such terms in subsections (a)(1) and (b)(1), respectively, of section 1859 (relating to definitions relating to Medicare+Choice organizations). ``(5) Prescription drug account.--The term `Prescription Drug Account' means the Prescription Drug Account (as established under section 1860K) in the Federal Supplementary Medical Insurance Trust Fund under section 1841. ``establishment of outpatient prescription drug benefit program ``Sec. 1860A. (a) Provision of Benefit.-- ``(1) In general.--As soon as the Prescription Drug Benefit and Cost Containment Act of 2003 can be implemented after the date of enactment of that Act, the Secretary shall provide for and administer an outpatient prescription drug benefit program under which each eligible beneficiary enrolled under this part shall be provided with coverage of covered outpatient drugs as follows: ``(A) Medicare+choice plan.--If the eligible beneficiary is eligible to enroll in a Medicare+Choice plan, the beneficiary-- ``(i) may enroll in such a plan; and ``(ii) if so enrolled, shall obtain coverage of covered outpatient drugs through such plan. ``(B) Medicare prescription drug plan.--If the eligible beneficiary is not enrolled in a Medicare+Choice plan, the beneficiary shall obtain coverage of covered outpatient drugs through enrollment in a plan offered by an eligible entity with a contract under this part. ``(2) Voluntary nature of program.--Nothing in this part shall be construed as requiring an eligible beneficiary to enroll in the program established under this part. ``(3) Scope of benefits.--The program established under this part shall provide for coverage of all therapeutic classes of covered outpatient drugs.
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