A bill to make improvements to the Medicare Prescriptions Drug, Improvement, and Modernization Act of 2003.

Summary: Medicare Preservation and Drug Price Fairness Act - Amends title XVIII (Medicare) of the Social Security Act, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, to repeal the prohibition against: (1) interference by the Secretary of Health and Human Services with the negotiations between drug manufacturers and pharmacies and prescription drug plan sponsors; and (2) any requirement by the Secretary of a formulary or institution of a price structure for the reimbursement of covered prescription drugs.

Repeals the Comparative Cost Adjustment Program.

Amends the Federal Food, Drug and Cosmetic Act to direct the Secretary to promulgate regulations allowing qualifying individuals who are neither pharmacists nor wholesalers (qualifying individuals) to import covered products (in addition to pharmacists and wholesalers, whom current law authorizes to import such products).



Repeals the requirement that regulations require that a product not coming directly from the first foreign recipient of the product from the manufacturer be approved for marketing in the United States.

Repeals requirements that the importer provide the Secretary with: (1) documentation from the foreign seller specifying the original source of the product and the amount of each lot of the product originally received; and (2) any other information that the Secretary determines is necessary to ensure the protection of the public health.

Revises testing requirements to provide that specified tests, including ones involving authenticity and degradation of products, shall not be required unless the importer is a wholesaler. (Currently either the importer or the manufacturer may conduct such tests). Exempts from importer-wholesaler testing a prescription drug subject to requirements for counterfeit-resistant packaging.

Makes permanent the requirements of Federal Food, Drug and Cosmetic Act for the importation of covered products.

Classifies prescription drugs as misbranded if they do not incorporate specified counterfeit-resistant technologies in their packaging.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to repeal its requirements for the importation of prescription drugs from Canada into the United States (effectively replacing them with the requirements of this Act.)

Removes Medicare Advantage (MA) prescription drug plans from the meaning of qualifying prescription drug plan.

Repeals authorization for the MA Regional Plan Stabilization Fund and Health Savings Accounts.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicare Preservation and Drug Price 
Fairness Act''.

SEC. 2. AUTHORITY TO NEGOTIATE PRICES.

    Subsection (i) of section 1860D-11, as added by section 101 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 
is repealed.

SEC. 3. REPEAL OF COMPARATIVE COST ADJUSTMENT (CCA) PROGRAM.

    Subtitle E of title II of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003, and the amendments made by 
such subtitle, are repealed.

SEC. 4. PHARMACEUTICAL MARKET ACCESS.

    (a) Importation of Prescription Drugs.--Section 804 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 384) is amended--
            (1) in subsection (a)--
                    (A) by striking ``The Secretary'' and inserting 
                ``Not later than 180 days after the date of the 
                enactment of the Medicare Prescription Drug, 
                Improvement, and Modernization Act of 2003, the 
                Secretary''; and
                    (B) by striking ``pharmacists and wholesalers'' and 
                inserting ``pharmacists, wholesalers, and qualifying 
                individuals'';
            (2) in subsection (b)--
                    (A) by amending paragraph (1) to read as follows:
            ``(1) require that each covered product imported pursuant 
        to such subsection complies with sections 501, 502, and 505, 
        and other applicable requirements of this Act; and'';
                    (B) in paragraph (2), by striking ``, including 
                subsection (d); and'' and inserting a period; and
                    (C) by striking paragraph (3);
            (3) in subsection (c), by inserting ``by pharmacists and 
        wholesalers (but not qualifying individuals)'' after 
        ``importation of covered products'';
            (4) in subsection (d)--
                    (A) by striking paragraphs (3) and (10);
                    (B) in paragraph (5), by striking ``, including the 
                professional license number of the importer, if any'';
                    (C) in paragraph (6)--
                            (i) in subparagraph (C), by inserting ``(if 
                        required under subsection (e))'' before the 
                        period;
                            (ii) in subparagraph (D), by inserting 
                        ``(if required under subsection (e))'' before 
                        the period; and
                            (iii) in subparagraph (E), by striking 
                        ``labeling'';
                    (D) in paragraph (7)--
                            (i) in subparagraph (A), by inserting ``(if 
                        required under subsection (e))'' before the 
                        period; and
                            (ii) by amending subparagraph (B) to read 
                        as follows:
                    ``(B) Certification from the importer or 
                manufacturer of such product that the product meets all 
                requirements of this Act.''; and
                    (E) by redesignating paragraphs (4) through (9) as 
                paragraphs (3) through (8), respectively;
            (5) by amending subsection (e) to read as follows:
    ``(e) Testing.--
            ``(1) In general.--Subject to paragraph (2), regulations 
        under subsection (a) shall require that testing referred to in 
        paragraphs (5) through (7) of subsection (d) be conducted by 
        the importer of the covered product, unless the covered product 
        is a prescription drug subject to the requirements of section 
        505B for counterfeit-resistant technologies.
            ``(2) Exception.--The testing requirements of paragraphs 
        (5) through (7) of subsection (d) shall not apply to an 
        importer unless the importer is a wholesaler.'';
            (6) in subsection (f), by striking ``or designated by the 
        Secretary, subject to such limitations as the Secretary 
        determines to be appropriate to protect the public health'';
            (7) in subsection (g)--
                    (A) by striking ``counterfeit or''; and
                    (B) by striking ``and the Secretary determines that 
                the public is adequately protected from counterfeit and 
                violative covered products being imported pursuant to 
                subsection (a)'';
            (8) in subsection (i)(1)--
                    (A) by amending subparagraph (A) to read as 
                follows:
                    ``(A) In general.--The Secretary shall conduct, or 
                contract with an entity to conduct, a study on the 
                imports permitted pursuant to subsection (a), including 
                consideration of the information received under 
                subsection (d). In conducting such study, the Secretary 
                or entity shall evaluate the compliance of importers 
                with regulations under subsection (a), and the 
                incidence of shipments pursuant to such subsection, if 
                any, that have been determined to be misbranded or 
                adulterated, and determine how such compliance 
                contrasts with the incidence of shipments of 
                prescription drugs transported within the United States 
that have been determined to be misbranded or adulterated.''; and
                    (B) in subparagraph (B), by striking ``Not later 
                than 2 years after the effective date of final 
                regulations under subsection (a),'' and inserting ``Not 
                later than 18 months after the date of the enactment of 
                the Medicare Prescription Drug, Improvement, and 
                Modernization Act of 2003,'';
            (9) in subsection (k)(2)--
                    (A) by redesignating subparagraphs (D) and (E) as 
                subparagraphs (E) and (F), respectively; and
                    (B) by inserting after subparagraph (C) the 
                following:
                    ``(D) The term `qualifying individual' means an 
                individual who is not a pharmacist or a wholesaler. ''; 
                and
            (10) by striking subsections (l) and (m).
    (b) Use of Counterfeit-Resistant Technologies To Prevent 
Counterfeiting.--
            (1) Misbranding.--Section 502 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 352; deeming drugs and devices to 
        be misbranded) is amended by adding at the end the following:
    ``(w) If it is a drug subject to section 503(b), unless the 
packaging of such drug complies with the requirements of section 505B 
for counterfeit-resistant technologies.''.
            (2) Requirements.--Title V of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
        after section 505A the following:

``SEC. 505B. COUNTERFEIT-RESISTANT TECHNOLOGIES.

    ``(a) Incorporation of Counterfeit-Resistant Technologies Into 
Prescription Drug Packaging.--The Secretary shall require that the 
packaging of any drug subject to section 503(b) incorporate--
            ``(1) overt optically variable counterfeit-resistant 
        technologies that are described in subsection (b) and comply 
        with the standards of subsection (c); or
            ``(2) technologies that have an equivalent function of 
        security, as determined by the Secretary.
    ``(b) Eligible Technologies.--Technologies described in this 
subsection--
            ``(1) shall be visible to the naked eye, providing for 
        visual identification of product authenticity without the need 
        for readers, microscopes, lighting devices, or scanners;
            ``(2) shall be similar to that used by the Bureau of 
        Engraving and Printing to secure United States currency;
            ``(3) shall be manufactured and distributed in a highly 
        secure, tightly controlled environment; and
            ``(4) should incorporate additional layers of non-visible 
        covert security features up to and including forensic 
        capability.
    ``(c) Standards for Packaging.--
            ``(1) Multiple elements.--For the purpose of making it more 
        difficult to counterfeit the packaging of drugs subject to 
        section 503(b), manufacturers of the drugs shall incorporate 
        the technologies described in subsection (b) into multiple 
        elements of the physical packaging of the drugs, including 
        blister packs, shrink wrap, package labels, package seals, 
        bottles, and boxes.
            ``(2) Labeling of shipping container.--Shipments of drugs 
        described in subsection (a) shall include a label on the 
        shipping container that incorporates the technologies described 
        in subsection (b), so that officials inspecting the packages 
        will be able to determine the authenticity of the shipment. 
        Chain of custody procedures shall apply to such labels and 
        shall include procedures applicable to contractual agreements 
        for the use and distribution of the labels, methods to audit 
        the use of the labels, and database access for the relevant 
        governmental agencies for audit or verification of the use and 
        distribution of the labels.''.
    (c) Repeal.--Subtitle C of title XI of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003, and the amendments 
made by such subtitle, are repealed.

SEC. 5. ASSURING ACCESS TO COVERAGE.

    Paragraph (3) of section 1860D-3(a), as added by section 101 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 
is amended to read as follows:
            ``(3) Qualifying plan defined.--For purposes of this 
        section, the term `qualifying plan' means a prescription drug 
        plan offered by a PDP sponsor.''.

SEC. 6. REPEAL OF MA REGIONAL PLAN STABILIZATION FUND.

    (a) In General.--Section 1858 of the Social Security Act, as added 
by section 221(c) of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003, is amended--
            (1) by striking subsection (e);
            (2) by redesignating subsections (f), (g), and (h) as 
        subsections (e), (f), and (g), respectively; and
            (3) in subsection (e), as so redesignated, by striking 
        ``subject to subsection (e),''.
    (b) Conforming Amendment.--Section 1851(i)(2) of the Social 
Security Act (42 U.S.C. 1395w-21(i)(2)), as amended by section 
221(d)(5) of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003, is amended by striking ``1858(h)'' and 
inserting ``1858(g)''.

SEC. 7. REPEAL OF HEALTH SAVINGS ACCOUNTS.

    Section 1201 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003, and the amendments made by such section, are 
repealed.

SEC. 8. EFFECTIVE DATE.

    (a) In General.--The amendments made by this Act shall take effect 
as if included in the enactment of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003.
    (b) Application of Laws.--If any amendment to any provision of any 
Act is repealed by this Act, such provision shall be applied and 
administered as if the amendment had never been enacted.