[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 563 Introduced in House (IH)]






109th CONGRESS
  1st Session
                                H. R. 563

 To amend part D of title XVIII of the Social Security Act to require 
 the Secretary of Health and Human Services to negotiate and disclose 
   lowest possible prices for prescription drug prices for Medicare 
    beneficiaries, and, with respect to the Federal Food, Drug, and 
  Cosmetic Act, to provide waivers that permit such beneficiaries to 
                 import prescription drugs from Canada.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 2, 2005

  Mr. Lynch introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
   Ways and Means, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
 To amend part D of title XVIII of the Social Security Act to require 
 the Secretary of Health and Human Services to negotiate and disclose 
   lowest possible prices for prescription drug prices for Medicare 
    beneficiaries, and, with respect to the Federal Food, Drug, and 
  Cosmetic Act, to provide waivers that permit such beneficiaries to 
                 import prescription drugs from Canada.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Prescription Drug Affordability Act 
of 2005''.

SEC. 2. NEGOTIATION AND DISCLOSURE OF LOWEST POSSIBLE PRICES FOR 
              PRESCRIPTION DRUGS UNDER MEDICARE.

    Section 1860D-11 of the Social Security Act (42 U.S.C. 1395w-111) 
is amended by striking subsection (i) (relating to noninterference) and 
by inserting the following:
    ``(i) Negotiation and Disclosure of Best Prices.--
            ``(1) Negotiation.--In order to ensure that beneficiaries 
        enrolled under prescription drug plans and MA-PD plans pay the 
        lowest possible price, the Secretary shall have and exercise 
        authority similar to that of the Secretary of Veterans Affairs, 
        the Secretary of Defense, and the heads of other Federal 
        agencies and departments that purchase prescription drugs in 
        bulk to negotiate contracts with manufacturers of covered part 
        D drugs, consistent with the requirements and in furtherance of 
        the goals of providing quality care and containing costs under 
        this part. In exercising such authority, the Secretary shall 
        negotiate the best possible prices for such drugs.
            ``(2) Disclosure.--The Secretary shall widely disseminate 
        information on the prices for covered part D drugs negotiated 
        under paragraph (1).''.

SEC. 3. MEDICARE BENEFICIARIES; WAIVER REQUIREMENT FOR PERSONAL 
              IMPORTATION OF PRESCRIPTION DRUGS FROM CANADA.

    (a) In General.-- With respect to the importation by Medicare 
beneficiaries of prescription drugs from Canada, the Secretary of 
Health and Human Services, acting through the Commissioner of Food and 
Drugs, shall in accordance with this section establish by regulation a 
waiver of prohibitions under the Federal Food, Drug, and Cosmetic Act 
that apply to the importation of drugs. Such a waiver shall permit such 
a beneficiary to import into the United States any prescription drug 
that--
            (1) is imported from Canada for personal use by the 
        beneficiary (not for resale);
            (2) is approved by the Secretary under section 505 of such 
        Act, is manufactured in an establishment registered with the 
        Secretary under section 510 of such Act, and is not a 
        controlled substance in schedule I, II, or III under section 
        202(c) of the Controlled Substances Act;
            (3) is imported from a Canadian pharmacy that has submitted 
        to the Secretary a registration that identifies the pharmacy 
        and provides documentation that the pharmacy is licensed in 
        Canada;
            (4) is imported in a quantity that does not (for that 
        instance of importation) exceed a 90-day supply;
            (5) at the time of importation, is accompanied by a copy of 
        a valid prescription for the drug for the beneficiary, issued 
        in the United States by a practitioner in accordance with 
        section 503(b) of the Federal Food, Drug, and Cosmetic Act, or 
        is accompanied by documentation that verifies the issuance of 
        such a prescription for the beneficiary;
            (6) is in the form of a final finished dosage; and
            (7) is imported under such other conditions as the 
        Secretary determines to be necessary to ensure public safety.
    (b) Definitions.--For purposes of subsection (a):
            (1) The term ``Medicare beneficiary'' means an individual 
        who is entitled to benefits under, or enrolled in, part A of 
        title XVIII of the Social Security Act, enrolled under part B 
        of such title, or both.
            (2) The term ``Secretary'' means the Secretary of Health 
        and Human Services.
                                 <all>