[Congressional Record Volume 149, Number 174 (Tuesday, November 25, 2003)]
[Senate]
[Pages S16022-S16023]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DASCHLE:
  S. 1974. A bill to make improvements to the Medicare Prescriptions 
Drug, Improvement, and Modernization Act of 2003; to the Committee on 
Finance.
  Mr. DASCHLE. Mr. President, by adopting the Medicare Conference 
Report today, the Senate has done great harm to one of our most 
successful and important social programs. As I have said over the past 
week, I believe that this will not be the end of the issue. I believe 
this is just the end of the first chapter.
  And I predict that the call from beneficiaries and future 
beneficiaries to repair this damage will be so loud that Congress will 
be compelled to act. We are hearing already from seniors in South 
Dakota and all across the country. For that reason, I am introducing 
today the Medicare Preservation and Drug Price Fairness Act. It is only 
a first step in addressing some of the many problems in the Republican 
Medicare bill--but it is an important step.
  This summer, the Senate passed a prescription drug bill. It was not 
perfect. But it was a start at providing the most necessary reform 
Medicare needs--covering prescription drugs for the program's 41 
million beneficiaries. And I reluctantly supported it.
  What came back from the Conference was no longer a bill to add a drug 
benefit to Medicare. It was a vehicle for Republicans to harm Medicare 
under the guise of ``reforms.''
  I am introducing a bill today to address some of the main weaknesses 
in the Conference bill. It will not be the last of these bills 
introduced. And it does not repair all of the damage done to Medicare 
by the Conference bill.
  The bill I introduce today is simply an initial effort to carve out 
some of the more egregious provisions of the Conference bill. It does 
not address the critical issues of the 2.7 million retirees who will 
lose their good coverage or the 6 million of the lowest-income seniors 
who will be worse off than they are now. It does not address the 
inadequacy of the drug benefit itself. We will come back to those 
issues in the near future.
  The Medicare Preservation and Drug Price Fairness Act is a start 
toward righting the wrongs done to Medicare today. It repeals the 
language in the Republican bill that prohibits Medicare from 
negotiating lower prices on behalf of beneficiaries. It repeals the 
highly controversial ``premium support'' demonstration projects that 
would force beneficiaries who do not want to join an HMO to pay higher 
premiums. It ensures that the guaranteed Medicare fallback is triggered 
whenever there are not two stand-alone drug plans available in an area 
so that seniors are not forced to join an HMO if the one that is 
available to them is priced too high. It repeals the $12 billion slush 
fund giveaway to HMOs and the $6 billion tax shelters for the wealthy 
and healthy. And, unlike the Republican bill, it allows Americans to 
obtain US-made drugs at lower prices safely from other industrialized 
countries.
  I noted earlier today when we voted on the Conference Report that 
there were few, if any, seniors looking on expectantly from the 
gallery. And in fact, we have heard from them in large numbers that 
they do not support the Conference bill. In contrast, the lobbies were 
full of well-tailored lobbyists--and the big drug companies and the 
HMOs are the ones celebrating the passage of the Conference bill. The 
Republicans got it backwards. The Medicare Preservation and Drug Price 
Fairness Act is a first step toward the bill Congress should have 
passed--a bill that truly benefits America's seniors.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1974

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

[[Page S16023]]

     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.

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