S.Amdt. 1072

1. Adds SEC. __. MEDICARE COVERAGE OF ALL ANTINEOPLASTIC AND CERTAIN OTHER DRUGS; PUBLIC DISCLOSURE OF MARKET-BASED DRUG PRICING INFORMATION at the end of title VI

   Adds a section

   In S. 1 · Reported to Senate

   Section 13031(j)(3) of the Consolidated Omnibus Budget Reconciliation Act of 1985 (19 U.S.C. 58c(j)(3)) is amended by striking "September 30, 2003" and inserting "September 30, 2013". Amend the title so as to read: "A bill to amend title XVIII of the Social Security Act to provide for a voluntary prescription drug benefit under the medicare program and to strengthen and improve the medicare program, and for other purposes.".

   Inserted: SEC. __. MEDICARE COVERAGE OF ALL ANTINEOPLASTIC AND CERTAIN OTHER DRUGS; PUBLIC DISCLOSURE OF MARKET-BASED DRUG PRICING INFORMATION.

   Inserted: (a) Medicare Coverage of All Antineoplastic and Certain Other Drugs.--

   Inserted: (1) In general.--Section 1861(s)(2)(Q) (42 U.S.C. 1395x(s)(2)(Q)) is amended by striking "prescribed for use as an anticancer chemotherapeutic agent" and all that follows and inserting "prescribed for use as--

   Inserted: "(i) an antineoplastic agent for a medically accepted anticancer indication (as defined in subsection (t)(2)(B)), excluding (except as provided in subparagraph (T)) drugs for chemotherapy-induced nausea; or

   Inserted: "(ii) an oral alternative to IV-administered medications, but only if the Secretary determines such coverage does not result, as estimated by the Secretary, in expenditures made under this title during any 5-year period that are greater than the expenditures that would have been made under this title during such period if such coverage was not provided.".

   Inserted: (2) Conforming amendment.--Section 1834(j)(5)(F)(iv) (42 U.S.C. 1395m(j)(5)(F)(iv)) is amended to read as follows:

   Inserted: "(iv) oral drugs described in section 1861(s)(2)(Q); and".

   Inserted: (3) Effective date.--The amendments made by this subsection shall apply only with respect to drugs furnished during the period that begins on or after the date that is 90 days after the date of the enactment of this Act and ends on January 1, 2006. After January 1, 2006, the Social Security Act shall be applied and administered as if the amendments made by this subsection had never been enacted.

   Inserted: (b) Public Disclosure of Market-Based Drug Pricing Information.--

   Inserted: (1) In general.--Section 1927(b)(3)(D) (42 U.S.C. 1396r-8(b)(3)(D)) is amended to read as follows:

   Inserted: "(D) Public availability of information.--

   Inserted: "(i) Timely availability of information.--Notwithstanding any other provision of law, with respect to a manufacturer with an agreement in effect under this section, not later than 30 days after the date the Secretary receives from such manufacturer the information required to be reported under this paragraph (or verifies such information with a wholesaler), the Secretary shall make the information described in clause (ii), including the identity of the manufacturer to which the information applies, publicly available through the Internet or other means of communication.

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   Inserted: "(ii) Information described.--The information described in this clause is the following:

   Inserted: "(I) Average manufacturer's price.--The average manufacturer price (as defined in subsection (k)(1)) for each of the manufacturer's covered outpatient drugs.

   Inserted: "(II) Best price.--With respect to single source drugs and innovator multiple source drugs, the manufacturer's best price (as defined in subsection (c)(1)(C)) for each of the manufacturer's covered outpatient drugs.

   Inserted: "(III) Base average manufacturer price and initial average manufacturer price for newly marketed drugs used to determine an additional rebate for single source and innovator multiple source drugs.--The average manufacturer price described in subparagraphs (A)(ii)(II) (without regard to the percentage increase determined under that subparagraph) and (B) of subsection (c)(2) for each dosage form and strength of a single source drug or an innovator multiple source drug used to determine, with respect to a rebate period, an additional rebate for such dosage form and strength for such a drug.

   Inserted: "(iii) Nondisclosure of certain information.--Notwithstanding any other provision of law, information disclosed by manufacturers (or verified with wholesalers) under an agreement with the Secretary of Veterans Affairs described in subsection (a)(6)(A) may not be disclosed except--

   Inserted: "(I) as the Secretary determines to be necessary to carry out this section;

   Inserted: "(II) to permit the Comptroller General to review the information provided; or

   Inserted: "(III) to permit the Director of the Congressional Budget Office to review the information provided.

   Inserted: "(iv) Rule of construction.--Nothing in this subparagraph shall be construed as affecting any requirement applicable to the Secretary of Veterans Affairs regarding the confidentiality of information required to be disclosed to the Secretary of Veterans Affairs by a manufacturer under section 8126 of title 38, United States Code.".

   Inserted: (2) Effective date; implementation.--

   Inserted: (A) Effective date.--The amendments made by paragraph (1) take effect upon the date of enactment of this Act and apply to the most recent reported price information under section 1927(b)(3) of the Social Security Act (42 U.S.C. 1396r-8(b)(3)) as of such date, and all such information reported under such section after such date.

   Inserted: (B) Additional period for implementation.--Notwithstanding the 30-day requirement for the public availability of market-based drug pricing information under section 1927(b)(3)(D)(i) of the Social Security Act (42 U.S.C. 1396r-8(b)(3)(D)(i)), with respect to the initial public availability of such information, the Secretary of Health and Human Services shall have up to 90 days from the date of the enactment of this Act in which to make such information so available.

   Inserted: (3) Authorization of appropriations.--There are authorized to be appropriated to carry out section 1927(b)(3)(D) of the Social Security Act (42 U.S.C. 1396r-8(b)(3)(D)), as amended by this subsection, such sums as may be necessary to carry out such section. Amounts appropriated pursuant to this subsection shall be in addition to amounts otherwise appropriated to carry out title XIX of such Act (42 U.S.C. 1396 et seq.).

   Original wording

   At the end of title VI, insert the following:

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As printed