[Congressional Record (Bound Edition), Volume 148 (2002), Part 11]
[Senate]
[Pages 15377-15401]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 4327. Mr. WELLSTONE submitted an amendment intended to be proposed 
by him to the bill S. 812, to amend the Federal Food, Drug, and 
Cosmetic Act to provide greater access to affordable pharmaceuticals; 
which was ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

     SEC. __. STATE PRESCRIPTION DRUG DISCOUNT.

       (a) Findings.--Congress makes the following findings:
       (1) More than 70,000,000 Americans, including more than 
     18,000,000 Medicare beneficiaries, are uninsured or 
     underinsured for prescription drug coverage.
       (2) High prescription drug prices are denying uninsured and 
     underinsured Americans access to medically necessary care, 
     thereby threatening their health and safety. Many of

[[Page 15378]]

     these Americans require repeated doctor or medical clinic 
     appointments, becoming sicker because they cannot afford to 
     take the drugs prescribed for them. Many are admitted to or 
     treated at hospitals because they cannot afford the drugs 
     prescribed for them that could have prevented the need for 
     hospitalization. Many enter expensive institutional care 
     settings because they cannot afford the prescription drugs 
     that could have supported them outside of an institution. In 
     each of these circumstances, uninsured and underinsured 
     residents too often become medicaid recipients because of 
     their inability to afford prescription drugs.
       (3) Pursuant to the Social Security Act, State medicaid 
     programs receive discounts in the form of rebates for 
     outpatient prescription drugs. On average, these rebates 
     provide discounts of more than 40 percent off retail prices.
       (4) In 49 States, individual Americans do not have access 
     to medicaid rebates. But in 1 State, since June 1, 2001, over 
     100,000 Americans have received discounts from those rebates 
     through the ``Healthy Maine'' program. This program, 
     established as a demonstration project pursuant to a waiver 
     from the Secretary of Health and Human Services has proven to 
     work. Americans need that program replicated in every State, 
     immediately.
       (5) The Federal and State governments are the only agents 
     that, as a practical matter, can play an effective role as a 
     market participant on behalf of Americans who are uninsured 
     or underinsured.
       (b) State Prescription Discount Program.--
       (1) In general.--Section 1927(a) of the Social Security Act 
     (42 U.S.C. 1396r-8(a)) is amended by adding at the end the 
     following:
       ``(7) Requirements relating to agreements for drugs 
     procured by individuals through state prescription drug 
     discount programs.--
       ``(A) In general.--A manufacturer meets the requirements of 
     this paragraph if the manufacturer enters into an agreement 
     with the State to make rebate payments for drugs covered by a 
     State prescription drug discount program in the same amounts 
     as are paid by the manufacturer to the State for such drugs 
     under a rebate agreement described in subsection (b).
       ``(B) State prescription drug discount program defined.--
       ``(i) In general.--In this paragraph, the term `State 
     prescription drug discount program' means a State program 
     under which, with respect to a rebate period, not less than 
     the amount equal to 95 percent of all the rebates paid to the 
     State under agreements entered into under subparagraph (A) 
     during such period is provided to eligible State residents in 
     the form of discounted prices for the purchase of outpatient 
     prescription drugs.
       ``(ii) Eligible state resident.--For purposes of clause 
     (i), the term `eligible State resident' means an individual 
     who is a State resident and--

       ``(I) who is eligible for benefits under title XVIII; or
       ``(II) whose income does not exceed 300 percent of the 
     income official poverty line (as defined by the Office of 
     Management and Budget, and revised annually in accordance 
     with section 673(2) of the Omnibus Budget Reconciliation Act 
     of 1981) applicable to a family of the size involved.

       ``(iii) Additional subsidies.--Nothing in this subparagraph 
     shall be construed as--

       ``(I) requiring a State to expend State funds to carry out 
     a State prescription drug discount program; or
       ``(II) prohibiting a State from electing to contribute 
     State funds to a State prescription drug discount program to 
     provide greater subsidies to eligible State residents for 
     outpatient prescription drugs covered under the program.

       ``(C) No offset against medical assistance.--Amounts 
     received by a State under an agreement entered into under 
     subparagraph (A) in any quarter shall not be considered to be 
     a reduction in the amount expended under the State plan in 
     the quarter for medical assistance for purposes of section 
     1903(a)(1).''.
       (2) Conforming Amendment.--The first sentence of section 
     1927(a)(1) of the Social Security Act (42 U.S.C. 1396r-
     8(a)(1)) is amended, by striking ``and paragraph (6)'' and 
     inserting ``, paragraph (6), and paragraph (7)''.
       (c) Enhanced Rebates for State Medicaid Programs.--Section 
     1927(b)(1)(B) of the Social Security Act (42 U.S.C. 1396r-
     8(b)(1)(B) is amended--
       (1) by striking ``Amounts'' and inserting the following:
       ``(i) In general.--Except as provided in clause (ii) and 
     subsection (a)(7)(C), amounts''; and
       (2) by adding at the end the following:
       ``(ii) Enhanced rebate.--In the case of a State that has a 
     State prescription drug discount program described in 
     subsection (a)(7) and that has entered into a rebate 
     agreement described in paragraph (1) or (4) of subsection (a) 
     that provides a greater rebate for a covered outpatient drug 
     than the rebate that would be paid for the covered outpatient 
     drug under subsection (c), then, notwithstanding clause (i), 
     only the amount equal to \1/2\ of the difference between the 
     amount received by the State in any quarter under such a 
     rebate agreement and the amount of the rebate that would be 
     paid under subsection (c) for such covered outpatient drug 
     shall be considered to be a reduction in the amount expended 
     under the State plan in the quarter for medical assistance 
     for purposes of section 1903(a)(1).''.
       (d) Effective Date.--The amendments made by this section 
     take effect on January 1, 2004.
                                 ______
                                 
  SA 4328. Mr. BINGAMAN submitted an amendment intended to be proposed 
by him to the bill S. 812, to amend the Federal Food, Drug, and 
Cosmetic Act to provide greater access to affordable pharmaceuticals; 
which was ordered to lie on the table; as follows:

       At the end, add the following:

     SEC. __. CLARIFICATION OF INCLUSION OF INPATIENT DRUG PRICES 
                   CHARGED TO CERTAIN PUBLIC HOSPITALS IN THE BEST 
                   PRICE EXEMPTIONS ESTABLISHED FOR PURPOSES OF 
                   THE MEDICAID DRUG REBATE PROGRAM.

       Section 1927(c)(1)(C)(ii) of the Social Security Act (42 
     U.S.C. 1396r-8(c)(1)(C)(ii)) is amended--
       (1) in subclause (II), by striking ``and'' at the end;
       (2) in subclause (Ill), by striking the period and 
     inserting ``; and''; and
       (3) by adding at the end the following:

       ``(IV) with respect to a covered entity described in 
     section 340B(a)(4)(L) of the Public Health Service Act, 
     shall, in addition to any prices excluded under clause 
     (i)(I), exclude any price charged on or after the date of 
     enactment of this subparagraph, for any drug, biological 
     product, or insulin provided as part of, or as incident to 
     and in the same setting as, inpatient hospital services (and 
     for which payment may be made under this title as part of 
     payment for and not as direct reimbursement for the drug).''.

                                 ______
                                 
  SA 4329. Mr. DURBIN (for himself, Mr. DeWine, Mr. Dorgan, Mr. Levin, 
and Mr. Johnson) submitted an amendment intended to be proposed by him 
to the bill S. 812, to amend the Federal Food, Drug, and Cosmetic Act 
to provide greater access to affordable pharmaceuticals; which was 
ordered to lie on the table; as follows:

       At the end, add the following:

     SEC. __. COMPREHENSIVE COVERAGE OF IMMUNOSUPPRESSIVE DRUGS 
                   UNDER THE MEDICARE PROGRAM.

       (a) In General.--Section 1861(s)(2)(J) of the Social 
     Security Act (42 U.S.C. 1395x(s)(2)(J)), as amended by 
     section 113(a) of the Medicare, Medicaid, and SCHIP Benefits 
     Improvement and Protection Act of 2000 (114 Stat. 2763A-473), 
     as enacted into law by section 1(a)(6) of Public Law 106-554, 
     is amended by striking ``, to an individual who receives'' 
     and all that follows before the semicolon at the end and 
     inserting ``to an individual who has received an organ 
     transplant''.
       (b) Effective Date.--The amendments made by this section 
     shall apply to drugs furnished on or after the date of 
     enactment of this Act.

     SEC. __. PROVISION OF APPROPRIATE COVERAGE OF 
                   IMMUNOSUPPRESSIVE DRUGS UNDER THE MEDICARE 
                   PROGRAM FOR ORGAN TRANSPLANT RECIPIENTS.

       (a) Continued Entitlement to Immunosuppressive Drugs.--
       (1) Kidney transplant recipients.--Section 226A(b)(2) of 
     the Social Security Act (42 U.S.C. 426-1(b)(2)) is amended by 
     inserting ``(except for coverage of immunosuppressive drugs 
     under section 1861(s)(2)(J))'' after ``shall end''.
       (2) Other transplant recipients.--The flush matter 
     following paragraph (2)(C)(ii)(II) of section 226(b) of the 
     Social Security Act (42 U.S.C. 426(b)) is amended by striking 
     ``of this subsection)'' and inserting ``of this subsection 
     and except for coverage of immunosuppressive drugs under 
     section 1861(s)(2)(J))''.
       (3) Application.--Section 1836 of the Social Security Act 
     (42 U.S.C. 1395o) is amended--
       (A) by striking ``Every individual who'' and inserting 
     ``(a) In General.--Every individual who''; and
       (B) by adding at the end the following new subsection:
       ``(b) Special Rules Applicable to Individuals Only Eligible 
     for Coverage of Immunosuppressive Drugs.--
       ``(1) In general.--In the case of an individual whose 
     eligibility for benefits under this title has ended except 
     for the coverage of immunosuppressive drugs by reason of 
     section 226(b) or 226A(b)(2), the following rules shall 
     apply:
       ``(A) The individual shall be deemed to be enrolled under 
     this part for purposes of receiving coverage of such drugs.
       ``(B) The individual shall be responsible for the full 
     amount of the premium under section 1839 in order to receive 
     such coverage.
       ``(C) The provision of such drugs shall be subject to the 
     application of--
       ``(i) the deductible under section 1833(b); and
       ``(ii) the coinsurance amount applicable for such drugs (as 
     determined under this part).

[[Page 15379]]

       ``(D) If the individual is an inpatient of a hospital or 
     other entity, the individual is entitled to receive coverage 
     of such drugs under this part.
       ``(2) Establishment of procedures in order to implement 
     coverage.--The Secretary shall establish procedures for--
       ``(A) identifying beneficiaries that are entitled to 
     coverage of immunosuppressive drugs by reason of section 
     226(b) or 226A(b)(2); and
       ``(B) distinguishing such beneficiaries from beneficiaries 
     that are enrolled under this part for the complete package of 
     benefits under this part.''.
       (4) Technical amendment.--Subsection (c) of section 226A of 
     the Social Security Act (42 U.S.C. 426-1), as added by 
     section 201(a)(3)(D)(ii) of the Social Security Independence 
     and Program Improvements Act of 1994 (Public Law 103-296; 108 
     Stat. 1497), is redesignated as subsection (d).
       (b) Extension of Secondary Payer Requirements for ESRD 
     Beneficiaries.--Section 1862(b)(1)(C) of the Social Security 
     Act (42 U.S.C. 1395y(b)(1)(C)) is amended by adding at the 
     end the following new sentence: ``With regard to 
     immunosuppressive drugs furnished on or after the date of 
     enactment of this sentence, this subparagraph shall be 
     applied without regard to any time limitation.''.
       (c) Effective Date.--The amendments made by this section 
     shall apply to drugs furnished on or after the date of 
     enactment of this Act.

     SEC. __. PLANS REQUIRED TO MAINTAIN COVERAGE OF 
                   IMMUNOSUPPRESSIVE DRUGS.

       (a) Application to Certain Health Insurance Coverage.--
       (1) In general.--Subpart 2 of part A of title XXVII of the 
     Public Health Service Act (42 U.S.C. 300gg-4 et seq.) is 
     amended by adding at the end the following:

     ``SEC. 2707. COVERAGE OF IMMUNOSUPPRESSIVE DRUGS.

       ``A group health plan (and a health insurance issuer 
     offering health insurance coverage in connection with a group 
     health plan) shall provide coverage of immunosuppressive 
     drugs that is at least as comprehensive as the coverage 
     provided by such plan or issuer on the day before the date of 
     enactment of this section, and such requirement shall be 
     deemed to be incorporated into this section.''.
       (2) Conforming amendment.--Section 2721(b)(2)(A) of the 
     Public Health Service Act (42 U.S.C. 300gg-21(b)(2)(A)) is 
     amended by inserting ``(other than section 2707)'' after 
     ``requirements of such subparts''.
       (b) Application to Group Health Plans and Group Health 
     Insurance Coverage Under the Employee Retirement Income 
     Security Act of 1974.--
       (1) In general.--Subpart B of part 7 of subtitle B of title 
     I of the Employee Retirement Income Security Act of 1974 (29 
     U.S.C. 1185 et seq.) is amended by adding at the end the 
     following new section:

     ``SEC. 714. COVERAGE OF IMMUNOSUPPRESSIVE DRUGS.

       ``A group health plan (and a health insurance issuer 
     offering health insurance coverage in connection with a group 
     health plan) shall provide coverage of immunosuppressive 
     drugs that is at least as comprehensive as the coverage 
     provided by such plan or issuer on the day before the date of 
     enactment of this sentence, and such requirement shall be 
     deemed to be incorporated into this section.''.
       (2) Conforming amendments.--
       (A) Section 732(a) of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1185(a)) is amended by 
     striking ``section 711'' and inserting ``sections 711 and 
     714''.
       (B) The table of contents in section 1 of the Employee 
     Retirement Income Security Act of 1974 is amended by 
     inserting after the item relating to section 713 the 
     following new item:

``Sec. 714. Coverage of immunosuppressive drugs.''.

       (c) Application to Group Health Plans Under the Internal 
     Revenue Code of 1986.--Subchapter B of chapter 100 of the 
     Internal Revenue Code of 1986 is amended--
       (1) in the table of sections, by inserting after the item 
     relating to section 9812 the following new item:

``Sec. 9813. Coverage of immunosuppressive drugs.'';

     and
       (2) by inserting after section 9812 the following:

     ``SEC. 9813. COVERAGE OF IMMUNOSUPPRESSIVE DRUGS.

       ``A group health plan shall provide coverage of 
     immunosuppressive drugs that is at least as comprehensive as 
     the coverage provided by such plan on the day before the date 
     of enactment of this sentence, and such requirement shall be 
     deemed to be incorporated into this section.''.
       (d) Effective Date.--The amendments made by this section 
     shall apply to plan years beginning on or after January 1, 
     2003.
                                 ______
                                 
  SA 4330. Mr. ENZI submitted an amendment intended to be proposed by 
him to the bill S. 812, to amend the Federal Food, Drug, and Cosmetic 
Act to provide greater access to affordable pharmaceuticals; which was 
ordered to lie on the table; as follows:

       Beginning on page 27, strike line 15 and all that follows 
     through page 28, line 18 and insert the following:
       ``(E) No claim for patent infringement.--An owner of a 
     patent with respect to''.
                                 ______
                                 
  SA 4331. Mr. ENZI submitted an amendment intended to be proposed by 
him to the bill S. 812, to amend the Federal Food, Drug, and Cosmetic 
Act to provide greater access to affordable pharmaceuticals; which was 
ordered to lie on the table; as follows:

       Beginning on page 27, strike line 15 and all that follows 
     through page 28, line 16, and insert the following:
       ``(E) Correction or deletion of patent information.--
       ``(i) In general.--A person that has filed an application 
     under subsection (b)(2) or (j) for a drug may submit to 
     arbitration a claim to require the holder of the application 
     to amend the application--

       ``(I) to correct patent information filed under 
     subparagraph (A); or
       ``(II) to delete the patent information in its entirety for 
     the reason that--

       ``(aa) the patent does not claim the drug for which the 
     application was approved; or
       ``(bb) the patent does not claim an approved method of 
     using the drug.
       ``(ii) American arbitration association.--Arbitration under 
     clause (i) shall be administered by the American Arbitration 
     Association, in accordance with the Commercial Arbitration 
     Rules.
       ``(iii) Decision.--

       ``(I) Timing.--Not later than 180 days after the date on 
     which an arbitrator receives a written request for 
     arbitration under this subparagraph, the arbitrator shall 
     render a decision with respect to the claim.
       ``(II) Limitation.--In rendering a decision under subclause 
     (I), the arbitrator shall not--

       ``(aa) order the correction of patent information filed 
     under subparagraph (B); or
       ``(bb) award monetary damages.

       ``(III) Binding effect.--A decision rendered under 
     subclause (I)--

       ``(aa) shall be final and binding; and
       ``(bb) may be entered in any court having jurisdiction over 
     the claim.
                                 ______
                                 
  SA 4332. Mr. ENZI submitted an amendment intended to be proposed by 
him to the bill S. 812, to amend the Federal Food, Drug, and Cosmetic 
Act to provide greater access to affordable pharmaceuticals; which was 
ordered to lie on the table; as follows:

       Beginning on page 28, strike line 17 and all that follows 
     through page 39, line 18, and insert the following:
       (2) Transition provision.--Each holder of an application 
     for approval of a new drug under section 505(b) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) that 
     has been approved before the date of enactment of this Act 
     shall amend the application to include the patent information 
     required under the amendment made by paragraph (1) not later 
     than the date that is 30 days after the date of enactment of 
     this Act (unless the Secretary of Health and Human Services 
     extends the date because of extraordinary or unusual 
     circumstances).
       (b) Filing With an Application.--Section 505 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended--
       (1) in subsection (b)(2)--
       (A) in subparagraph (A), by striking ``and'' at the end;
       (B) in subparagraph (B), by striking the period at the end 
     and inserting ``; and''; and
       (C) by adding at the end the following:
       ``(C) with respect to a patent that claims both the drug 
     and a method of using the drug or claims more than 1 method 
     of using the drug for which the application is filed--
       ``(i) a certification under subparagraph (A)(iv) on a 
     claim-by-claim basis; and
       ``(ii) a statement under subparagraph (B) regarding the 
     method of use claim.''; and
       (2) in subsection (j)(2)(A), by inserting after clause 
     (viii) the following:

     ``With respect to a patent that claims both the drug and a 
     method of using the drug or claims more than 1 method of 
     using the drug for which the application is filed, the 
     application shall contain a certification under clause 
     (vii)(IV) on a claim-by-claim basis and a statement under 
     clause (viii) regarding the method of use claim.''.

     SEC. 4. LIMITATION OF 30-MONTH STAY TO CERTAIN PATENTS.

       (a) Abbreviated New Drug Applications.--Section 505(j)(5) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355(j)(5)) is amended--
       (1) in subparagraph (B)--
       (A) in clause (iii)--
       (i) by striking ``(iii) If the applicant made a 
     certification described in subclause (IV) of paragraph 
     (2)(A)(vii),'' and inserting the following:
       ``(iii) Subclause (iv) certification with respect to 
     certain patents.--If the applicant made a certification 
     described in paragraph (2)(A)(vii)(IV) with respect to a 
     patent (other than a patent that claims a process for 
     manufacturing the listed drug) for which

[[Page 15380]]

     patent information was filed with the Secretary under 
     subsection (c)(2)(A),''; and
       (ii) by adding at the end the following: ``The 30-month 
     period provided under the second sentence of this clause 
     shall not apply to a certification under paragraph 
     (2)(A)(vii)(IV) made with respect to a patent for which 
     patent information was filed with the Secretary under 
     subsection (c)(2)(B).'';
       (B) by redesignating clause (iv) as clause (v); and
       (C) by inserting after clause (iii) the following:
       ``(iv) Subclause (iv) certification with respect to other 
     patents.--

       ``(I) In general.--If the applicant made a certification 
     described in paragraph (2)(A)(vii)(IV) with respect to a 
     patent not described in clause (iii) for which patent 
     information was published by the Secretary under subsection 
     (c)(2)(D), the approval shall be made effective on the date 
     that is 45 days after the date on which the notice provided 
     under paragraph (2)(B) was received, unless a civil action 
     for infringement of the patent, accompanied by a motion for 
     preliminary injunction to enjoin the applicant from engaging 
     in the commercial manufacture or sale of the drug, was filed 
     on or before the date that is 45 days after the date on which 
     the notice was received, in which case the approval shall be 
     made effective--

       ``(aa) on the date of a court action declining to grant a 
     preliminary injunction; or
       ``(bb) if the court has granted a preliminary injunction 
     prohibiting the applicant from engaging in the commercial 
     manufacture or sale of the drug--
       ``(AA) on issuance by a court of a determination that the 
     patent is invalid or is not infringed;
       ``(BB) on issuance by a court of an order revoking the 
     preliminary injunction or permitting the applicant to engage 
     in the commercial manufacture or sale of the drug; or
       ``(CC) on the date specified in a court order under section 
     271(e)(4)(A) of title 35, United States Code, if the court 
     determines that the patent is infringed.

       ``(II) Cooperation.--Each of the parties shall reasonably 
     cooperate in expediting a civil action under subclause (I).
       ``(III) Expedited notification.--If the notice under 
     paragraph (2)(B) contains an address for the receipt of 
     expedited notification of a civil action under subclause (I), 
     the plaintiff shall, on the date on which the complaint is 
     filed, simultaneously cause a notification of the civil 
     action to be delivered to that address by the next business 
     day.''; and

       (2) by inserting after subparagraph (B) the following:
       ``(C) Failure to bring infringement action.--If, in 
     connection with an application under this subsection, the 
     applicant provides an owner of a patent notice under 
     paragraph (2)(B) with respect to the patent, and the owner of 
     the patent fails to bring a civil action against the 
     applicant for infringement of the patent on or before the 
     date that is 45 days after the date on which the notice is 
     received, the owner of the patent shall be barred from 
     bringing a civil action for infringement of the patent 
     against the applicant with respect to the application.''.
       (b) Other Applications.--Section 505(c)) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) (as amended 
     by section 9(a)(3)(A)(iii)) is amended--
       (1) in paragraph (3)--
       (A) in subparagraph (C)--
       (i) by striking ``(C) If the applicant made a certification 
     described in clause (iv) of subsection (b)(2)(A),'' and 
     inserting the following:
       ``(C) Clause (iv) certification with respect to certain 
     patents.--If the applicant made a certification described in 
     subsection (b)(2)(A)(iv) with respect to a patent (other than 
     a patent that claims a process for manufacturing the listed 
     drug) for which patent information was filed with the 
     Secretary under paragraph (2)(A),''; and
       (ii) by adding at the end the following: ``The 30-month 
     period provided under the second sentence of this 
     subparagraph shall not apply to a certification under 
     subsection (b)(2)(A)(iv) made with respect to a patent for 
     which patent information was filed with the Secretary under 
     paragraph (2)(B).''; and
       (B) by inserting after subparagraph (C) the following:
       ``(D) Clause (iv) certification with respect to other 
     patents.--
       ``(i) In general.--If the applicant made a certification 
     described in subsection (b)(2)(A)(iv) with respect to a 
     patent not described in subparagraph (C) for which patent 
     information was published by the Secretary under paragraph 
     (2)(D), the approval shall be made effective on the date that 
     is 45 days after the date on which the notice provided under 
     subsection (b)(3) was received, unless a civil action for 
     infringement of the patent, accompanied by a motion for 
     preliminary injunction to enjoin the applicant from engaging 
     in the commercial manufacture or sale of the drug, was filed 
     on or before the date that is 45 days after the date on which 
     the notice was received, in which case the approval shall be 
     made effective--

       ``(I) on the date of a court action declining to grant a 
     preliminary injunction; or
       ``(II) if the court has granted a preliminary injunction 
     prohibiting the applicant from engaging in the commercial 
     manufacture or sale of the drug--

       ``(aa) on issuance by a court of a determination that the 
     patent is invalid or is not infringed;
       ``(bb) on issuance by a court of an order revoking the 
     preliminary injunction or permitting the applicant to engage 
     in the commercial manufacture or sale of the drug; or
       ``(cc) on the date specified in a court order under section 
     271(e)(4)(A) of title 35, United States Code, if the court 
     determines that the patent is infringed.
       ``(ii) Cooperation.--Each of the parties shall reasonably 
     cooperate in expediting a civil action under clause (i).
       ``(iii) Expedited notification.--If the notice under 
     subsection (b)(3) contains an address for the receipt of 
     expedited notification of a civil action under clause (i), 
     the plaintiff shall, on the date on which the complaint is 
     filed, simultaneously cause a notification of the civil 
     action to be delivered to that address by the next business 
     day.''; and
       (2) by inserting after paragraph (3) the following:
       ``(4) Failure to bring infringement action.--If, in 
     connection with an application under subsection (b)(2), the 
     applicant provides an owner of a patent notice under 
     subsection (b)(3) with respect to the patent, and the owner 
     of the patent fails to bring a civil action against the 
     applicant for infringement of the patent on or before the 
     date that is 45 days after the date on which the notice is 
     received, the owner of the patent shall be barred from 
     bringing a civil action for infringement of the patent 
     against the applicant with respect to the application.''.
                                 ______
                                 
  SA 4333. Mr. ENZI submitted an amendment intended to be proposed by 
him to the bill S. 812, to amend the Federal Food, Drug, and Cosmetic 
Act to provide greater access to affordable pharmaceuticals; which was 
ordered to lie on the table; as follows:

       Beginning on page 31, strike line 12 and all that follows 
     through page 40 and insert the following:

     SEC. 4. 30-MONTH STAY.

       (a) Abbreviated New Drug Applications.--Section 505(j)(5) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355(j)(5)) is amended--
       (1) in subparagraph (B)(iii)--
       (A) by striking ``(iii) If the applicant'' and inserting 
     the following:
       ``(iii) Subclause (iv) certification.--If the applicant''; 
     and
       (B) by adding at the end the following: ``The 30-month 
     period provided under this clause shall not apply to a 
     certification under paragraph (2)(A)(vii)(IV) made with 
     respect to a patent for which patent information was filed 
     with the Secretary after the filing of the application under 
     this subsection that contains the certification.''; and
       (2) by inserting after subparagraph (B) the following:
       ``(C) Failure to bring infringement action.--If, in 
     connection with an application under this subsection, the 
     applicant provides an owner of a patent notice under 
     paragraph (2)(B) with respect to the patent, and the owner of 
     the patent fails to bring a civil action against the 
     applicant for infringement of the patent on or before the 
     date that is 45 days after the date on which the notice is 
     received, the owner of the patent shall be barred from 
     bringing a civil action for infringement of the patent in 
     connection with the development, manufacture, use, offer to 
     sell, or sale of the drug for which the application was filed 
     or approved under this subsection.''.
       (b) Other Applications.--Section 505(c)) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) is amended--
       (1) in paragraph (3)(C)--
       (A) by striking ``(C) If the applicant'' and inserting the 
     following:
       ``(C) Clause (iv) certification.--If the applicant''; and
       (B) by adding at the end the following: ``The 30-month 
     period provided under this subparagraph shall not apply to a 
     certification under subsection (b)(2)(A)(iv) made with 
     respect to a patent for which patent information was filed 
     with the Secretary after the filing of the application 
     described in subsection (b)(2) that contains the 
     certification.''; and
       (2) by inserting after paragraph (3) the following:
       ``(4) Failure to bring infringement action.--If, in 
     connection with an application under subsection (b)(2), the 
     applicant provides an owner of a patent notice under 
     subsection (b)(3) with respect to the patent, and the owner 
     of the patent fails to bring a civil action against the 
     applicant for infringement of the patent on or before the 
     date that is 45 days after the date on which the notice is 
     received, the owner of the patent shall be barred from 
     bringing a civil action for infringement of the patent in 
     connection with the development, manufacture, use, offer to 
     sell, or sale of the drug for which the application was filed 
     or approved under subsection (b)(2).''.
                                 ______
                                 
  SA 4334. Mr. NICKLES submitted an amendment intended to be proposed 
by him to the bill S. 812, to amend the Federal Food, Drug, and 
Cosmetic Act to provide greater access to affordable

[[Page 15381]]

pharmaceuticals; which was ordered to lie on the table; as follows:

       At the appropriate place, add the following:

     SEC. __. NONAPPLICATION OF STATE AUTHORITY TO ENTER INTO DRUG 
                   REBATE AGREEMENTS IF THE AGREEMENTS WOULD 
                   RESULT IN INCREASED MEDICAID DRUG COSTS.

       Notwithstanding any other provision of this Act, section 
     1927 of the Social Security Act (42 U.S.C. 1396r-8) shall be 
     applied without regard to subsection (l) (as added by this 
     Act) if the Secretary of Health and Human Services determines 
     that the application of that subsection would result in an 
     increase in expenditures under the medicaid program 
     established under title XIX of the Social Security Act (42 
     U.S.C. 1396 et seq.) for covered outpatient drugs (as defined 
     in section 1927(k)(2) of that Act (42 U.S.C. 1396r-8(k)(2)).
                                 ______
                                 
  SA 4335. Mr. NICKLES submitted an amendment intended to be proposed 
to amendment SA 4299 proposed by Mr. Reid (for Mr. Dorgan (for himself, 
Mr. Wellstone, Mr. Jeffords, Ms. Stabenow, Ms. Collins, Mr. Levin, Mr. 
Johnston, Mr. Miller, Mr. Durbin, Mr. Feingold, and Mr. Harkin)) to the 
bill (S. 812) to amend the Federal Food, Drug, and Cosmetic Act to 
provide greater access to affordable pharmaceuticals; which was ordered 
to lie on the table; as follows:

       At the appropriate place, add the following:

     SEC. __. NONAPPLICATION OF STATE AUTHORITY TO ENTER INTO DRUG 
                   REBATE AGREEMENTS IF THE AGREEMENTS WOULD 
                   RESULT IN INCREASED MEDICAID DRUG COSTS.

       Notwithstanding any other provision of this Act, section 
     1927 of the Social Security Act (42 U.S.C. 1396r-8) shall be 
     applied without regard to subsection (l) (as added by this 
     Act) if the Secretary of Health and Human Services determines 
     that the application of that subsection would result in an 
     increase in expenditures under the medicaid program 
     established under title XIX of the Social Security Act (42 
     U.S.C. 1396 et seq.) for covered outpatient drugs (as defined 
     in section 1927(k)(2) of that Act (42 U.S.C. 1396r-8(k)(2)).
                                 ______
                                 
  SA 4336. Mr. NICKLES submitted an amendment intended to be proposed 
by him to the bill S. 812, to amend the Federal Food, Drug, and 
Cosmetic Act to provide greater access to affordable pharmaceuticals; 
which was ordered to lie on the table; as follows:

       At the appropriate place, add the following:

     SEC. __. SCOPE OF APPLICATION OF TEMPORARY INCREASE IN FMAP.

       Section __(a)(5) of this Act (relating to the scope of 
     application of the temporary increase in the State Federal 
     medical assistance percentage) is amended--
       (1) by striking the period at the end of subparagraph (B) 
     and inserting ``; or''; and
       (2) by adding at the end the following:
       ``(C) payments that are in excess of the aggregate upper 
     payment limits applicable to the medicaid program, as 
     determined under part 447 of title 42 of the Code of Federal 
     Regulations, (or that would be considered to be in excess of 
     such limits if a transition period described in section 
     447.272(e) or 447.321(e) of title 42 of the Code of Federal 
     Regulations) did not apply to the payments).''.
                                 ______
                                 
  SA 4337. Mr. NICKLES submitted an amendment intended to be proposed 
to amendment SA 4299 proposed by Mr. Reid (for Mr. Dorgan (for himself, 
Mr. Wellstone, Mr. Jeffords, Ms. Stabenow, Ms. Collins, Mr. Levin, Mr. 
Johnson, Mr. Miller, Mr. Durbin, Mr. Feingold, and Mr. Harkin)) to the 
bill (S. 812) to amend the Federal Food, Drug, and Cosmetic Act to 
provide greater access to affordable pharmaceuticals; which was ordered 
to lie on the table; as follows:

       At the appropriate place, add the following:
       ``(C) payments that are in excess of the aggregate upper 
     payment limits applicable to the medicaid program, as 
     determined under part 447 of title 42 of the Code of Federal 
     Regulations, (or that would be considered to be in excess of 
     such limits if a transition period described in section 
     447.272(e) or 447.321(e) of title 42 of the Code of Federal 
     Regulations) did not apply to the payments).''.
                                 ______
                                 
  SA 4338. Mr. NICKLES submitted an amendment intended to be proposed 
by him to the bill S. 812, to amend the Federal Food, Drug, and 
Cosmetic Act to provide greater access to affordable pharmaceuticals; 
which was ordered to lie on the table; as follows:

       At the appropriate place, add the following:

     SEC. __. CLARIFICATION OF STATE AUTHORITY RELATING TO 
                   MEDICAID DRUG REBATE AGREEMENTS.

       Section 1927 of the Social Security Act (42 U.S.C. 1396r-8) 
     is amended by adding at the end the following:
       ``(l) Rule of Construction.--
       ``(1) In general.--With respect to individuals described in 
     paragraph (2) who are enrolled in a State prescription drug 
     program described in paragraph (3), nothing in this section 
     shall be construed as prohibiting a State from--
       ``(A) directly entering into rebate agreements (on the 
     State's own initiative or under a section 1115 waiver 
     approved by the Secretary before, on, or after the date of 
     enactment of this subsection) that are similar to a rebate 
     agreement described in subsection (b) with a manufacturer for 
     purposes of ensuring the affordability of outpatient 
     prescription drugs in order to provide access to such drugs 
     by such individuals; or
       ``(B) making prior authorization (that satisfies the 
     requirements of subsection (d) and that does not violate any 
     requirements of this title that are designed to ensure access 
     to medically necessary prescribed drugs for individuals 
     enrolled in the State program under this title) a condition 
     of not participating in such a similar rebate agreement.
       ``(2) Individuals described.--For purposes of paragraph 
     (1), individuals described in this paragraph are 
     individuals--
       ``(A) whose family income does not exceed 200 percent of 
     the income official poverty line (as defined by the Office of 
     Management and Budget, and revised annually in accordance 
     with section 673(2) of the Omnibus Budget Reconciliation Act 
     of 1981) applicable to a family of the size involved; and
       ``(B) who are not otherwise eligible for medical assistance 
     under this title.
       ``(3) State prescription drug program described.--For 
     purposes of paragraph (1), a State prescription drug program 
     described in this paragraph is a State program that was in 
     effect as of July 1, 2002, and under which State appropriated 
     funds substantially paid for the cost of outpatient 
     prescription drugs for individuals described in paragraph (1) 
     who were enrolled in the program.''.
                                 ______
                                 
  SA 4339. Mr. NICKLES submitted an amendment intended to be proposed 
to amendment SA 4299 proposed by Mr. Reid (for Mr. Dorgan (for himself, 
Mr. Wellstone, Mr. Jeffords, Ms. Stabenow, Ms. Collins, Mr. Levin, Mr. 
Johnson, Mr. Miller, Mr. Durbin, Mr. Feingold, and Mr. Harkin) to the 
bill (S. 812) to amend the Federal Food, Drug, and Cosmetic Act to 
provide greater access to affordable pharmaceuticals; which was ordered 
to lie on the table; as follows:
       At the appropriate place, add the following:

     SEC. __. CLARIFICATION OF STATE AUTHORITY RELATING TO 
                   MEDICAID DRUG REBATE AGREEMENTS.

       Section 1927 of the Social Security Act (42 U.S.C. 1396r-8) 
     is amended by adding at the end the following:
       ``(l) Rule of Construction.--
       ``(1) In general.--With respect to individuals described in 
     paragraph (2) who are enrolled in a State prescription drug 
     program described in paragraph (3), nothing in this section 
     shall be construed as prohibiting a State from--
       ``(A) directly entering into rebate agreements (on the 
     State's own initiative or under a section 1115 waiver 
     approved by the Secretary before, on, or after the date of 
     enactment of this subsection) that are similar to a rebate 
     agreement described in subsection (b) with a manufacturer for 
     purposes of ensuring the affordability of outpatient 
     prescription drugs in order to provide access to such drugs 
     by such individuals; or
       ``(B) making prior authorization (that satisfies the 
     requirements of subsection (d) and that does not violate any 
     requirements of this title that are designed to ensure access 
     to medically necessary prescribed drugs for individuals 
     enrolled in the State program under this title) a condition 
     of not participating in such a similar rebate agreement.
       ``(2) Individuals described.--For purposes of paragraph 
     (1), individuals described in this paragraph are 
     individuals--
       ``(A) whose family income does not exceed 200 percent of 
     the income official poverty line (as defined by the Office of 
     Management and Budget, and revised annually in accordance 
     with section 673(2) of the Omnibus Budget Reconciliation Act 
     of 1981) applicable to a family of the size involved; and
       ``(B) who are not otherwise eligible for medical assistance 
     under this title.
       ``(3) State prescription drug program described.--For 
     purposes of paragraph (1), a State prescription drug program 
     described in this paragraph is a State program that was in 
     effect as of July 1, 2002, and under which State appropriated 
     funds substantially paid for the cost of outpatient 
     prescription drugs for individuals described in paragraph (1) 
     who were enrolled in the program.''.
                                 ______
                                 
  SA 4340. Mr. LEAHY submitted an amendment intended to be proposed by 
him to the bill S. 812, to amend the Federal Food, Drug, and Cosmetic 
Act to provide greater access to affordable pharmaceuticals; which was 
ordered to lie on the table; as follows:

       At the end insert the following:

[[Page 15382]]



                 TITLE __--DRUG COMPETITION ACT OF 2002

     SEC. __01. SHORT TITLE.

       This title may be cited as the ``Drug Competition Act of 
     2002''.

     SEC. __02. FINDINGS.

       Congress finds that--
       (1) prescription drug prices are increasing at an alarming 
     rate and are a major worry of many senior citizens and 
     American families;
       (2) there is a potential for companies with patent rights 
     regarding brand-name drugs and companies which could 
     manufacture generic versions of such drugs to enter into 
     financial deals that could tend to restrain trade and greatly 
     reduce competition and increase prescription drug 
     expenditures for American citizens; and
       (3) enhancing competition among these companies can 
     significantly reduce prescription drug expenditures for 
     Americans.

     SEC. __03. PURPOSES.

       The purposes of this title are--
       (1) to provide timely notice to the Department of Justice 
     and the Federal Trade Commission regarding agreements between 
     companies with patent rights regarding branded drugs and 
     companies which could manufacture generic versions of such 
     drugs; and
       (2) by providing timely notice, to enhance the 
     effectiveness and efficiency of the enforcement of the 
     antitrust and competition laws of the United States.

     SEC. __04. DEFINITIONS.

       In this title:
       (1) ANDA.--The term ``ANDA'' means an Abbreviated New Drug 
     Application, as defined under section 201(aa) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 321(aa)).
       (2) Assistant attorney general.--The term ``Assistant 
     Attorney General'' means the Assistant Attorney General in 
     charge of the Antitrust Division of the Department of 
     Justice.
       (3) Brand name drug.--The term ``brand name drug'' means a 
     drug approved under section 505(c) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355(c)).
       (4) Brand name drug company.--The term ``brand name drug 
     company'' means the party that received Food and Drug 
     Administration approval to market a brand name drug pursuant 
     to an NDA, where that drug is the subject of an ANDA, or a 
     party owning or controlling enforcement of any patent listed 
     in the Approved Drug Products With Therapeutic Equivalence 
     Evaluations of the Food and Drug Administration for that 
     drug, under section 505(b) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(b)).
       (5) Commission.--The term ``Commission'' means the Federal 
     Trade Commission.
       (6) Generic drug.--The term ``generic drug'' is a product 
     that the Food and Drug Administration has approved under 
     section 505(j) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(j)).
       (7) Generic drug applicant.--The term ``generic drug 
     applicant'' means a person who has filed or received approval 
     for an ANDA under section 505(j) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355(j)).
       (8) NDA.--The term ``NDA'' means a New Drug Application, as 
     defined under section 505(b) et seq. of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355(b) et seq.)

     SEC. __05. NOTIFICATION OF AGREEMENTS.

       (a) In General.--
       (1) Requirement.--A generic drug applicant that has 
     submitted an ANDA containing a certification under section 
     505(j)(2)(vii)(IV) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(j)(2)(vii)(IV)) and a brand name drug 
     company that enter into an agreement described in paragraph 
     (2), prior to the generic drug that is the subject of the 
     application entering the market, shall each file the 
     agreement as required by subsection (b).
       (2) Definition.--An agreement described in this paragraph 
     is an agreement regarding--
       (A) the manufacture, marketing or sale of the brand name 
     drug that is the subject of the generic drug applicant's 
     ANDA;
       (B) the manufacture, marketing or sale of the generic drug 
     that is the subject of the generic drug applicant's ANDA; or
       (C) the 180-day period referred to in section 
     505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(j)(5)(B)(iv)) as it applies to such ANDA or to 
     any other ANDA based on the same brand name drug.
       (b) Filing.--
       (1) Agreement.--The generic drug applicant and the brand 
     name drug company entering into an agreement described in 
     subsection (a)(2) shall file with the Assistant Attorney 
     General and the Commission the text of any such agreement, 
     except that the generic drug applicant and the brand-name 
     drug company shall not be required to file an agreement that 
     solely concerns--
       (A) purchase orders for raw material supplies;
       (B) equipment and facility contracts; or
       (C) employment or consulting contracts.
       (2) Other agreements.--The generic drug applicant and the 
     brand name drug company entering into an agreement described 
     in subsection (a)(2) shall file with the Assistant Attorney 
     General and the Commission the text of any other agreements 
     not described in subsection (a)(2) between the generic drug 
     applicant and the brand name drug company which are 
     contingent upon, provide a contingent condition for, or are 
     otherwise related to an agreement which must be filed under 
     this title.
       (3) Description.--In the event that any agreement required 
     to be filed by paragraph (1) or (2) has not been reduced to 
     text, both the generic drug applicant and the brand name drug 
     company shall file written descriptions of the non-textual 
     agreement or agreements that must be filed sufficient to 
     reveal all of the terms of the agreement or agreements.

     SEC. __6. FILING DEADLINES.

       Any filing required under section __05 shall be filed with 
     the Assistant Attorney General and the Commission not later 
     than 10 business days after the date the agreements are 
     executed.

     SEC. __07. DISCLOSURE EXEMPTION.

       Any information or documentary material filed with the 
     Assistant Attorney General or the Commission pursuant to this 
     title shall be exempt from disclosure under section 552 of 
     title 5, and no such information or documentary material may 
     be made public, except as may be relevant to any 
     administrative or judicial action or proceeding. Nothing in 
     this section is intended to prevent disclosure to either body 
     of Congress or to any duly authorized committee or 
     subcommittee of the Congress.

     SEC. __08. ENFORCEMENT.

       (a) Civil Penalty.--Any brand name drug company or generic 
     drug applicant which fails to comply with any provision of 
     this title shall be liable for a civil penalty of not more 
     than $11,000, for each day during which such entity is in 
     violation of this title. Such penalty may be recovered in a 
     civil action brought by the United States, or brought by the 
     Commission in accordance with the procedures established in 
     section 16(a)(1) of the Federal Trade Commission Act (15 
     U.S.C. 56(a)).
       (b) Compliance and Equitable Relief.--If any brand name 
     drug company or generic drug applicant fails to comply with 
     any provision of this title, the United States district court 
     may order compliance, and may grant such other equitable 
     relief as the court in its discretion determines necessary or 
     appropriate, upon application of the Assistant Attorney 
     General or the Commission. Equitable relief under this 
     subsection may include an order by the district court which 
     renders unenforceable, by the brand name drug company or 
     generic drug applicant failing to file, any agreement that 
     was not filed as required by this title for the period of 
     time during which the agreement was not filed by the company 
     or applicant as required by this title.

     SEC. __09. RULEMAKING.

       The Commission, with the concurrence of the Assistant 
     Attorney General and by rule in accordance with section 553 
     of title 5 United States Code, consistent with the purposes 
     of this title--
       (1) may define the terms used in this title;
       (2) may exempt classes of persons or agreements from the 
     requirements of this title; and
       (3) may prescribe such other rules as may be necessary and 
     appropriate to carry out the purposes of this title.

     SEC. __10. SAVINGS CLAUSE.

       Any action taken by the Assistant Attorney General or the 
     Commission, or any failure of the Assistant Attorney General 
     or the Commission to take action, under this title shall not 
     bar any proceeding or any action with respect to any 
     agreement between a brand name drug company and a generic 
     drug applicant at any time under any other provision of law, 
     nor shall any filing under this title constitute or create a 
     presumption of any violation of any antitrust or competition 
     laws.

     SEC. __11. EFFECTIVE DATE.

       This title shall--
       (1) take effect 30 days after the date of enactment of this 
     title; and
       (2) shall apply to agreements described in section __05 
     that are entered into 30 days after the date of enactment of 
     this title.
                                 ______
                                 
  SA 4341. Mr. DAYTON submitted an amendment intended to be proposed by 
him to the bill S. 812 to amend the Federal Food, Drug, and Cosmetic 
Act to provide greater access to affordable pharmaceuticals; which was 
ordered to lie on the table; as follows:

       At the end, add the following:

              TITLE __--MEDICARE AMBULANCE PAYMENT REFORM

     SEC. __01. AMBULANCE PAYMENT RATES.

       (a) Payment Rates.--
       (1) In general.--Section 1834(l)(3) of the Social Security 
     Act (42 U.S.C. 1395m(l)(3)) is amended to read as follows:
       ``(3) Payment rates.--In the case of any ambulance service 
     furnished under this part in 2003 or any subsequent year, the 
     Secretary shall set the payment rates under the fee schedule 
     for such service at amounts equal to the payment rate under 
     the fee schedule for that service furnished during the 
     previous year, increased by the percentage increase in the 
     Consumer Price Index for all urban consumers (United States 
     city average) for the 12-month period ending with June of the 
     previous year.''.

[[Page 15383]]

       (2) Conforming amendment.--Section 221(c) of the Medicare, 
     Medicaid, and SCHIP Benefits Improvement and Protection Act 
     of 2000 (114 Stat. 2763A-487), as enacted into law by section 
     1(a)(6) of Public Law 106-554, is repealed.
       (3) Technical amendment.--
       (A) In general.--Paragraph (8) of section 1834(l) of the 
     Social Security Act (42 U.S.C. 1395m(l)), as added by section 
     221(a) of the Medicare, Medicaid, and SCHIP Benefits 
     Improvement and Protection Act of 2000 (114 Stat. 2763A-487), 
     as enacted into law by section 1(a)(6) of Public Law 106-554, 
     is redesignated as paragraph (9).
       (B) Effective date.--The amendment made by subparagraph (A) 
     shall take effect as if included in the enactment of such 
     section 221(a).
       (b) Use of Medical Conditions for Coding Ambulance 
     Services.--Section 1834(l)(7) of the Social Security Act (42 
     U.S.C. 1395m(l)(7)) is amended to read as follows:
       ``(7) Coding system.--
       ``(A) In general.--The Secretary shall, in accordance with 
     section 1173(c)(1)(B), establish a system or systems for the 
     coding of claims for ambulance services for which payment is 
     made under this subsection, including a code set specifying 
     the medical condition of the individual who is transported 
     and the level of service that is appropriate for the 
     transportation of an individual with that medical condition.
       ``(B) Medical conditions.--The code set established under 
     subparagraph (A) shall--
       ``(i) take into account the list of medical conditions 
     developed in the course of the negotiated rulemaking process 
     conducted under paragraph (1); and
       ``(ii) notwithstanding any other provision of law, be 
     adopted as a standard code set under section 1173(c).''.

     SEC. __02. PRUDENT LAYPERSON STANDARD FOR EMERGENCY AMBULANCE 
                   SERVICES UNDER MEDICARE AND MEDICAID.

       (a) Ambulance Services for Medicare Fee-for-Service 
     Beneficiaries.--Section 1861(s)(7) of the Social Security Act 
     (42 U.S.C. 1395x(s)(7)) is amended by inserting before the 
     semicolon at the end the following: ``, except that such 
     regulations shall not fail to treat ambulance services as 
     medical and other health services solely because the ultimate 
     diagnosis of the individual receiving the ambulance services 
     results in the conclusion that ambulance services were not 
     necessary, as long as the request for ambulance services is 
     made after the sudden onset of a medical condition that would 
     be classified as an emergency medical condition (as defined 
     in section 1852(d)(3)(B)).''.
       (b) Ambulance Services for Medicare+Choice Enrollees.--
     Section 1852(d)(3)(A) of the Social Security Act (42 U.S.C. 
     1395w-22(d)(3)(A)) is amended by inserting ``(including the 
     services described in section 1861(s)(7))'' after 
     ``outpatient services'' in the matter preceding clause (i).
       (c) Ambulance Services in Medicaid Managed Care Plans.--
     Section 1932(b)(2)(B) of the Social Security Act (42 U.S.C. 
     1396u-2(b)(2)(B)) is amended by inserting ``(including the 
     services described in section 1861(s)(7) (if covered by the 
     State plan))'' after ``outpatient services'' in the matter 
     preceding clause (i).
       (d) Effective Date.--The amendments made by this section 
     shall apply with respect to services provided on and after 
     the date of enactment of the Act.
                                 ______
                                 
  SA 4342. Mr. FRIST submitted an amendment intended to be proposed by 
him to the bill S. 812, to amend the Federal Food, Drug, and Cosmetic 
Act to provide greater access to affordable pharmaceuticals; which was 
ordered to lie on the table; as follows:

       Strike section 7.
                                 ______
                                 
  SA 4343. Mr. FRIST submitted an amendment intended to be proposed by 
him to the bill S. 812, to amend the Federal Food, Drug, and Cosmetic 
Act to provide greater access to affordable pharmaceuticals; which was 
ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

       TITLE __--IMPROVED VACCINE AFFORDABILITY AND AVAILABILITY

     SEC. __01. SHORT TITLE.

       This title may be cited as the ``Improved Vaccine 
     Affordability and Availability Act''.

                    Subtitle A--State Vaccine Grants

     SEC. __11. AVAILABILITY OF INFLUENZA VACCINE.

       Section 317(j) of the Public Health Service Act (42 U.S.C. 
     247b(j)) is amended by adding at the end the following:
       ``(3)(A) For the purpose of carrying out activities 
     relating to influenza vaccine under the immunization program 
     under this subsection, there are authorized to be 
     appropriated such sums as may be necessary for each of fiscal 
     years 2003 and 2004. Such authorization shall be in addition 
     to amounts available under paragraphs (1) and (2) for such 
     purpose.
       ``(B) The authorization of appropriations established in 
     subparagraph (A) shall not be effective for a fiscal year 
     unless the total amount appropriated under paragraphs (1) and 
     (2) for the fiscal year is not less than such total for 
     fiscal year 2000.
       ``(C) The purposes for which amounts appropriated under 
     subparagraph (A) are available to the Secretary include 
     providing for improved State and local infrastructure for 
     influenza immunizations under this subsection in accordance 
     with the following:
       ``(i) Increasing influenza immunization rates in 
     populations considered by the Secretary to be at high risk 
     for influenza-related complications and in their contacts.
       ``(ii) Recommending that health care providers actively 
     target influenza vaccine that is available in September, 
     October, and November to individuals who are at increased 
     risk for influenza-related complications and to their 
     contacts.
       ``(iii) Providing for the continued availability of 
     influenza immunizations through December of such year, and 
     for additional periods to the extent that influenza vaccine 
     remains available.
       ``(iv) Encouraging States, as appropriate, to develop 
     contingency plans (including plans for public and 
     professional educational activities) for maximizing influenza 
     immunizations for high-risk populations in the event of a 
     delay or shortage of influenza vaccine.
       ``(D) The Secretary shall submit to the Committee on Energy 
     and Commerce of the House of Representatives, and the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate, periodic reports describing the activities of the 
     Secretary under this subsection regarding influenza vaccine. 
     The first such report shall be submitted not later than June 
     6, 2003, the second report shall be submitted not later than 
     June 6, 2004, and subsequent reports shall be submitted 
     biennially thereafter.''.

     SEC. __12. PROGRAM FOR INCREASING IMMUNIZATION RATES FOR 
                   ADULTS AND ADOLESCENTS; COLLECTION OF 
                   ADDITIONAL IMMUNIZATION DATA.

       (a) Activities of Centers for Disease Control and 
     Prevention.--Section 317(j) of the Public Health Service Act 
     (42 U.S.C. 247b(j)), as amended by section __11, is further 
     amended by adding at the end the following:
       ``(4)(A) For the purpose of carrying out activities to 
     increase immunization rates for adults and adolescents 
     through the immunization program under this subsection, and 
     for the purpose of carrying out subsection (k)(2), there are 
     authorized to be appropriated $50,000,000 for fiscal year 
     2003, and such sums as may be necessary for each of the 
     fiscal years 2004 through 2006. Such authorization is in 
     addition to amounts available under paragraphs (1), (2), and 
     (3) for such purposes.
       ``(B) In expending amounts appropriated under subparagraph 
     (A), the Secretary shall give priority to adults and 
     adolescents who are medically underserved and are at risk for 
     vaccine-preventable diseases, including as appropriate 
     populations identified through projects under subsection 
     (k)(2)(E).
       ``(C) The purposes for which amounts appropriated under 
     subparagraph (A) are available include (with respect to 
     immunizations for adults and adolescents) the payment of the 
     costs of storing vaccines, outreach activities to inform 
     individuals of the availability of the immunizations, and 
     other program expenses necessary for the establishment or 
     operation of immunization programs carried out or supported 
     by States or other public entities pursuant to this 
     subsection.
       ``(5) The Secretary shall annually submit to Congress a 
     report that--
       ``(A) evaluates the extent to which the immunization system 
     in the United States has been effective in providing for 
     adequate immunization rates for adults and adolescents, 
     taking into account the applicable year 2010 health 
     objectives established by the Secretary regarding the health 
     status of the people of the United States; and
       ``(B) describes any issues identified by the Secretary that 
     may affect such rates.
       ``(6) In carrying out this subsection and paragraphs (1) 
     and (2) of subsection (k), the Secretary shall consider 
     recommendations regarding immunizations that are made in 
     reports issued by the Institute of Medicine.''.
       (b) Research, Demonstrations, and Education.--Section 
     317(k) of the Public Health Service Act (42 U.S.C. 247b(k)) 
     is amended--
       (1) by redesignating paragraphs (2) through (4) as 
     paragraphs (3) through (5), respectively; and
       (2) by inserting after paragraph (1) the following:
       ``(2) The Secretary, directly and through grants under 
     paragraph (1), shall provide for a program of research, 
     demonstration projects, and education in accordance with the 
     following:
       ``(A) The Secretary shall coordinate with public and 
     private entities (including nonprofit private entities), and 
     develop and disseminate guidelines, toward the goal of 
     ensuring that immunizations are routinely offered to adults 
     and adolescents by public and private health care providers.
       ``(B) The Secretary shall cooperate with public and private 
     entities to obtain information for the annual evaluations 
     required in subsection (j)(5)(A).
       ``(C) The Secretary shall (relative to fiscal year 2001) 
     increase the extent to which the Secretary collects data on 
     the incidence, prevalence, and circumstances of diseases

[[Page 15384]]

     and adverse events that are experienced by adults and 
     adolescents and may be associated with immunizations, 
     including collecting data in cooperation with commercial 
     laboratories.
       ``(D) The Secretary shall ensure that the entities with 
     which the Secretary cooperates for purposes of subparagraphs 
     (A) through (C) include managed care organizations, 
     community-based organizations that provide health services, 
     and other health care providers.
       ``(E) The Secretary shall provide for projects to identify 
     racial and ethnic minority groups and other health disparity 
     populations for which immunization rates for adults and 
     adolescents are below such rates for the general population, 
     and to determine the factors underlying such disparities.''.

     SEC. __13. IMMUNIZATION AWARENESS.

       (a) Development of Information Concerning Meningitis.--
       (1) In general.--The Secretary of Health and Human 
     Services, in consultation with the Director of the Centers 
     for Disease Control and Prevention, shall develop and make 
     available to entities described in paragraph (2) information 
     concerning bacterial meningitis and the availability and 
     effectiveness of vaccinations for populations targeted by the 
     Advisory Committee on Immunization Practices (an advisory 
     committee established by the Secretary of Health and Human 
     Services, acting through the Centers for Disease Control and 
     Prevention).
       (2) Entities.--An entity is described in this paragraph if 
     the entity--
       (A) is--
       (i) a college or university; or
       (ii) any other facility with a setting similar to a 
     dormitory that houses age-appropriate populations for whom 
     the Advisory Committee on Immunization Practices recommends 
     such a vaccination; and
       (B) is determined appropriate by the Secretary of Health 
     and Human Services.
       (b) Development of Information Concerning Hepatitis.--
       (1) In general.--The Secretary of Health and Human 
     Services, in consultation with the Director of the Centers 
     for Disease Control and Prevention, shall develop and make 
     available to entities described in paragraph (2) information 
     concerning hepatitis A and B and the availability and 
     effectiveness of vaccinations with respect to such diseases.
       (2) Entities.--An entity is described in this paragraph if 
     the entity--
       (A) is--
       (i) a health care clinic that serves individuals diagnosed 
     as being infected with HIV or as having other sexually 
     transmitted diseases;
       (ii) an organization or business that counsels individuals 
     about international travel or who arranges for such travel;
       (iii) a police, fire or emergency medical services 
     organization that responds to natural or man-made disasters 
     or emergencies;
       (iv) a prison or other detention facility;
       (v) a college or university; or
       (vi) a public health authority or children's health service 
     provider in areas of intermediate or high endemicity for 
     hepatitis A as defined by the Centers for Disease Control and 
     Prevention; and
       (B) is determined appropriate by the Secretary of Health 
     and Human Services.

     SEC. __14. SUPPLY OF VACCINES.

       (a) In General.--The Secretary of Health and Human 
     Services, acting through the Director of the Centers for 
     Disease Control and Prevention, shall prioritize, acquire, 
     and maintain a supply of such prioritized vaccines sufficient 
     to provide vaccinations throughout a 6-month period.
       (b) Proceeds.--Any proceeds received by the Secretary of 
     Health and Human Services from the sale of vaccines contained 
     in the supply described in subsection (a), shall be available 
     to the Secretary for the purpose of purchasing additional 
     vaccines for the supply. Such proceeds shall remain available 
     until expended.
       (c) Authorization of Appropriations.--There are authorized 
     to be appropriated for the purpose of carrying out subsection 
     (a) such sums as may be necessary for each of fiscal years 
     2003 through 2008.

            Subtitle B--Vaccine Injury Compensation Program

     SEC. __21. ADMINISTRATIVE REVISION OF VACCINE INJURY TABLE.

       Section 2114 of the Public Health Service Act (42 U.S.C. 
     300aa-14) is amended--
       (1) in subsection (c), by striking paragraph (1) and 
     inserting the following:
       ``(1) The Secretary may promulgate regulations to modify in 
     accordance with paragraph (3) the Vaccine Injury Table. In 
     promulgating such regulations, the Secretary shall provide 
     for notice and for at least 60 days opportunity for public 
     comment.''; and
       (2) in subsection (d), by striking ``90 days'' and 
     inserting ``60 days''.

     SEC. __22. EQUITABLE RELIEF.

       Section 2111(a)(2)(A) of the Public Health Service Act (42 
     U.S.C. 300aa-11(a)(2)(A)) is amended by striking ``No 
     person'' and all that follows through ``and--'' and inserting 
     the following: ``No person may bring or maintain a civil 
     action against a vaccine administrator or manufacturer in a 
     State or Federal court for damages arising from, or equitable 
     relief relating to, a vaccine-related injury or death 
     associated with the administration of a vaccine after October 
     1, 1988 and no such court may award damages or equitable 
     relief for any such vaccine-related injury or death, unless 
     the person proves past or present physical injury and a 
     timely petition has been filed, in accordance with section 
     2116 for compensation under the Program for such injury or 
     death and--''.

     SEC. __23. PARENT OR OTHER THIRD PARTY PETITIONS FOR 
                   COMPENSATION.

       (a) Limitations on Derivative Petitions.--Section 
     2111(a)(2) of the Public Health Service Act (42 U.S.C. 300aa-
     11(a)(2)) is amended--
       (1) in subparagraph (B), by inserting ``or (B)'' after 
     ``subparagraph (A)'';
       (2) by redesignating subparagraph (B) as subparagraph (C); 
     and
       (3) by inserting after subparagraph (A) the following:
       ``(B)(i) No parent, legal guardian, or spouse (referred to 
     in this title as a parent or other third party) may bring or 
     maintain a civil action against a vaccine administrator or 
     manufacturer in a Federal or State court for damages or 
     equitable relief relating to a vaccine-related injury or 
     death, including damages for loss of consortium, society, 
     companionship, or services, loss of earnings, medical or 
     other expenses, and emotional distress, and no court may 
     award damages or equitable relief in such an action, unless--
       ``(I) the person who sustained the underlying vaccine-
     related injury or death upon which such parent's or other 
     third party's claim is premised has, in accordance with 
     section 2112, been awarded compensation in a final judgment 
     of the United States Court of Federal Claims and such 
     judgment is subject to no further appeal or review;
       ``(II) such parent or other third party timely filed a 
     derivative petition, in accordance with section 2116; and
       ``(III)(aa) the United States Court of Federal Claims has 
     issued judgment under section 2112 on the derivative 
     petition, and such parent or other third party elects under 
     section 2121(a) to file a civil action; or
       ``(bb) such parent or other third party elects to withdraw 
     such derivative petition under section 2121(b) or such 
     petition is considered withdrawn under such section.
       ``(ii) Any civil action brought in accordance with this 
     subparagraph shall be subject to the standards and procedures 
     set forth in sections 2122 and 2123, regardless of whether 
     the action arises directly from a vaccine-related injury or 
     death associated with the administration of a vaccine. In a 
     case in which the person who sustained the underlying 
     vaccine-related injury or death upon which such parent's or 
     other third party's civil action is premised elects under 
     section 2121(a) to receive the compensation awarded, such 
     parent or other third party may not bring a civil action for 
     damages or equitable relief, and no court may award damages 
     or equitable relief, for any injury or loss of the type set 
     forth in section 2115(a) or that might in any way overlap 
     with or otherwise duplicate compensation of the type 
     available under section 2115(a).''.
       (b) Eligible Persons.--Section 2111(a)(9) of the Public 
     Health Service Act (42 U.S.C. 300aa-11(a)(9)) is amended by 
     striking the period and inserting ``and to a parent or other 
     third party to the extent such parent or other third party 
     seeks damages or equitable relief relating to a vaccine-
     related injury or death sustained by a person who is 
     qualified to file a petition for compensation under the 
     Program.''.
       (c) Petitioners.--Section 2111(b) of the Public Health 
     Service Act (42 U.S.C. 300aa-11(b)) is amended--
       (1) in paragraph (1)--
       (A) in subparagraph (A), by striking ``(B)'' and inserting 
     ``(C)'';
       (B) by redesignating subparagraph (B) as subparagraph (C); 
     and
       (C) by inserting after subparagraph (A) the following:
       ``(B) Except as provided in subparagraph (C), any parent or 
     other third party with respect to a person--
       ``(i) who has sustained a vaccine-related injury or death;
       ``(ii) who has filed a petition for compensation under the 
     Program (or whose legal representative has filed such a 
     petition as authorized in subparagraph (A)); and
       ``(iii) who has, in accordance with section 2112, been 
     awarded compensation in a final judgment of the United States 
     Court of Federal Claims that is subject to no further appeal 
     or review;
     may, if such parent or other third party meets the 
     requirements of subsection (d), file a derivative petition 
     under this section.''; and
       (2) in paragraph (2)--
       (A) by inserting ``by or on behalf of the person who 
     sustained the vaccine-related injury or death'' after 
     ``filed''; and
       (B) by adding at the end the following: ``A parent or other 
     third party may file only 1 derivative petition with respect 
     to each administration of a vaccine.''.
       (d) Derivative Petition Contents.--Section 2111 of the 
     Public Health Service Act (42 U.S.C. 300aa-11) is amended--
       (1) by redesignating subsections (d) and (e) as subsections 
     (e) and (f), respectively; and
       (2) by inserting after subsection (c) the following:
       ``(d) Derivative Petitions.--

[[Page 15385]]

       ``(1) If the parent or other third party with respect to 
     the person who sustained the vaccine-related injury or death 
     seeks compensation under the Program, such parent or other 
     third party shall file a timely derivative petition for 
     compensation under the Program in accordance with this 
     section.
       ``(2) Such a derivative petition shall contain--
       ``(A) except for records that are unavailable as described 
     in subsection (c)(3), an affidavit, and supporting 
     documentation, demonstrating that--
       ``(i) such person was, in accordance with section 2112, 
     previously awarded compensation for the underlying vaccine-
     related injury or death upon which such parent's or other 
     third party's derivative petition is premised in a final 
     judgment of the United States Court of Federal Claims and 
     such judgment is subject to no further appeal or review;
       ``(ii) the derivative petition was filed not later than 60 
     days after the date on which such judgment became final and 
     subject to no further appeal or review;
       ``(iii) such parent or other third party suffered a loss 
     compensable under section 2115(b) as a result of the vaccine-
     related injury or death sustained by such person; and
       ``(iv) such parent or other third party has not previously 
     collected an award or settlement of a civil action for 
     damages for such loss; and
       ``(B) records establishing such parent's or other third 
     party's relationship to the person who sustained the vaccine-
     related injury or death.''.
       (e) Determination of Eligibility for Compensation.--Section 
     2113(a)(1) of the Public Health Service Act (42 U.S.C. 300aa-
     13(a)(1)) is amended--
       (1) in subparagraph (A), by inserting ``or, as applicable, 
     section 2111(d)'' before the comma; and
       (2) in subparagraph (B), by inserting ``or, as applicable, 
     that the injury or loss described in the derivative petition 
     is due to factors unrelated to the vaccine-related injury or 
     death'' after ``the petition''.
       (f) Compensation.--Section 2115 of the Public Health 
     Service Act (42 U.S.C. 300aa-15) is amended--
       (1) by redesignating subsections (b) through (j) as 
     subsections (c) through (k), respectively;
       (2) by inserting after subsection (a) the following:
       ``(b) Derivative Petitions.--Compensation awarded under the 
     Program to a parent or other third party who files a 
     derivative petition under section 2111 for a loss sustained 
     as a result of a vaccine-related injury or death sustained by 
     the injured party shall include compensation, if any, for 
     loss of consortium, society, companionship, or services, in 
     an amount not to exceed the lesser of $250,000 or the total 
     amount of compensation awarded to the person who sustained 
     the underlying vaccine-related injury or death.'';
       (3) in subsection (e)(2), as so redesignated by paragraph 
     (1)--
       (A) by striking ``(2) and (3)'' and inserting ``(2), (3), 
     and (4)''; and
       (B) by inserting ``and subsection (b),'' after ``(a),'';
       (4) in subsection (g), as so redesignated by paragraph (1), 
     in paragraph (4)(B), by striking ``subsection (j)'' and 
     inserting ``subsection (k)'';
       (5) in subsection (j), as so redesignated by paragraph 
     (1)--
       (A) in paragraph (1), by striking ``subsection (j)'' and 
     inserting ``subsection (k)''; and
       (B) in paragraph (2), by inserting ``, or to a parent or 
     other third party with respect to a person who sustained a 
     vaccine-related injury or death,'' after ``death''; and
       (6) in subsection (k), as so redesignated by paragraph (1), 
     by striking ``subsection (f)(4)(B)'' and inserting 
     ``subsection (g)(4)(B)''.

     SEC. __24. JURISDICTION TO DISMISS ACTIONS IMPROPERLY 
                   BROUGHT.

       Section 2111(a)(3) of the Public Health Service Act (42 
     U.S.C. 300aa-11(a)(3)) is amended by adding at the end the 
     following: ``If any civil action which is barred under 
     subparagraph (A) or (B) of paragraph (2) is filed or 
     maintained in a State court, or any vaccine administrator or 
     manufacturer is made a party to any civil action brought in 
     State court (other than a civil action which may be brought 
     under paragraph (2)) for damages or equitable relief for a 
     vaccine-related injury or death associated with the 
     administration of a vaccine after October 1, 1988, the civil 
     action may be removed by the defendant or defendants to the 
     United States Court of Federal Claims, which shall have 
     jurisdiction over such civil action, and which shall dismiss 
     such action. The notice required by section 1446 of title 28, 
     United States Code, shall be filed with the United States 
     Court of Federal Claims, and that court shall proceed in 
     accordance with sections 1446 through 1451 of title 28, 
     United States Code.''.

     SEC. __25. APPLICATION.

       Section 2111(a)(9) of the Public Health Service Act (42 
     U.S.C. 300aa-11(a)(9)) is amended by striking ``This'' and 
     inserting ``Except as provided in paragraph (2), this''.

     SEC. __26. CLARIFICATION OF WHEN INJURY IS CAUSED BY FACTOR 
                   UNRELATED TO ADMINISTRATION OF VACCINE.

       Section 2113(a)(2)(B) of the Public Health Service Act (42 
     U.S.C. 300aa-13(a)(2)(B)) is amended--
       (1) by inserting ``structural lesions, genetic disorders,'' 
     after ``and related anoxia),'';
       (2) by inserting ``(without regard to whether the cause of 
     the infection, toxin, trauma, structural lesion, genetic 
     disorder, or metabolic disturbance is known)'' after 
     ``metabolic disturbances''; and
       (3) by striking ``but'' and inserting ``and''.

     SEC. __27. INCREASE IN AWARD IN THE CASE OF A VACCINE-RELATED 
                   DEATH AND FOR PAIN AND SUFFERING.

       Section 2115(a) of the Public Health Service Act (42 U.S.C. 
     300aa-15(a)) is amended--
       (1) in paragraph (2), by striking ``$250,000'' and 
     inserting ``$350,000''; and
       (2) in paragraph (4), by striking ``$250,000'' and 
     inserting ``$350,000''.

     SEC. __28. BASIS FOR CALCULATING PROJECTED LOST EARNINGS.

       Section 2115(a)(3)(B) of the Public Health Service Act (42 
     U.S.C. 300aa-15(a)(3)(B)) is amended by striking ``loss of 
     earnings'' and all that follows and inserting the following: 
     ``loss of earnings determined on the basis of the annual 
     estimate of the average (mean) gross weekly earnings of wage 
     and salary workers age 18 and over (excluding the 
     incorporated self-employed) in the private non-farm sector 
     (which includes all industries other than agricultural 
     production crops and livestock), as calculated annually by 
     the Bureau of Labor Statistics from the quarter sample data 
     of the Current Population Survey, or as calculated by such 
     similar method as the Secretary may prescribe by regulation, 
     less appropriate taxes and the average cost of a health 
     insurance policy, as determined by the Secretary.''.

     SEC. __29. ALLOWING COMPENSATION FOR FAMILY COUNSELING 
                   EXPENSES AND EXPENSES OF ESTABLISHING 
                   GUARDIANSHIP.

       (a) Family Counseling Expenses in Post-1988 Cases.--Section 
     2115(a) of the Public Health Service Act (42 U.S.C. 300aa-
     15(a)) is amended by adding at the end to following:
       ``(5) Actual unreimbursable expenses that have been or will 
     be incurred for family counseling as is determined to be 
     reasonably necessary and that result from the vaccine-related 
     injury from which the petitioner seeks compensation.''.
       (b) Expenses of Establishing Guardianships in Post-1988 
     Cases.--Section 2115(a) of the Public Health Service Act (42 
     U.S.C. 300aa-15(a)), as amended by subsection (a), is further 
     amended by adding at the end the following:
       ``(6) Actual unreimbursable expenses that have been, or 
     will be reasonably incurred to establish and maintain a 
     guardianship or conservatorship for an individual who has 
     suffered a vaccine-related injury, including attorney fees 
     and other costs incurred in a proceeding to establish and 
     maintain such guardianship or conservatorship.''.
       (c) Conforming Amendment for Cases From 1988 and Earlier.--
     Section 2115 of the Public Health Service Act (42 U.S.C. 
     300aa-15) is amended in subsection (c), as so redesignated by 
     section __23(f)--
       (1) in paragraph (2), by striking ``and'' at the end;
       (2) in paragraph (3), by striking ``(e)'' and inserting 
     ``(f))'';
       (3) by redesignating paragraph (3) as paragraph (5); and
       (4) by inserting after paragraph (2), the following:
       ``(3) family counseling expenses (as provided for in 
     paragraph (5) of subsection (a));
       ``(4) expenses of establishing guardianships (as provided 
     for in paragraph (6) of subsection (a)); and''.

     SEC. __30. ALLOWING PAYMENT OF INTERIM COSTS.

       Section 2115 of the Public Health Service Act (42 U.S.C. 
     300aa-15) is amended in subsection (f), as so redesignated by 
     section __23(f), by adding at the end the following:
       ``(4) A special master or court may make an interim award 
     of costs if--
       ``(A) the case involves a vaccine administered on or after 
     October 1, 1988;
       ``(B) the special master or court has determined whether or 
     not the petitioner is entitled to compensation under the 
     Program;
       ``(C) the award is limited to other costs (within the 
     meaning of paragraph (1)(B)) incurred in the proceeding; and
       ``(D) the petitioner provides documentation verifying the 
     expenditure of the amount for which compensation is 
     sought.''.

     SEC. __31. PROCEDURE FOR PAYING ATTORNEYS' FEES.

       Section 2115 of the Public Health Service Act (42 U.S.C. 
     300aa-15), is amended in subsection (f), as so redesignated 
     by section __23(f) and amended by section __30, by adding at 
     the end the following:
       ``(5) When a special master or court awards attorney fees 
     or costs under paragraph (1) or (4), it may order that such 
     fees or costs be payable solely to the petitioner's attorney 
     if--
       ``(A) the petitioner expressly consents; or
       ``(B) the special master or court determines, after 
     affording to the Secretary and to all interested persons the 
     opportunity to submit relevant information, that--
       ``(i) the petitioner cannot be located or refuses to 
     respond to a request by the special master or court for 
     information, and there is

[[Page 15386]]

     no practical alternative means to ensure that the attorney 
     will be reimbursed for such fees or costs expeditiously; or
       ``(ii) there are otherwise exceptional circumstances and 
     good cause for paying such fees or costs solely to the 
     petitioner's attorney.''.

     SEC. __32. EXTENSION OF STATUTE OF LIMITATIONS.

       (a) General Rule.--Section 2116(a) of the Public Health 
     Service Act (42 U.S.C. 300aa-16(a)) is amended--
       (1) in paragraph (2) by striking ``36 months'' and 
     inserting ``6 years''; and
       (2) in paragraph (3), by striking ``48 months'' and 
     inserting ``6 years''.
       (b) Claims Based on Revisions to Table.--Section 2116 of 
     the Public Health Service Act (42 U.S.C. 300aa-16) is amended 
     by striking subsection (b) and inserting the following:
       ``(b) Effect of Revised Table.--If at any time the Vaccine 
     Injury Table is revised and the effect of such revision is to 
     make an individual eligible for compensation under the 
     program, where, before such revision, such individual was not 
     eligible for compensation under the program, or to 
     significantly increase the likelihood that an individual will 
     be able to obtain compensation under the program, such person 
     may, and shall before filing a civil action for equitable 
     relief or monetary damages, notwithstanding section 
     2111(b)(2), file a petition for such compensation if--
       ``(1) the vaccine-related death or injury with respect to 
     which the petition is filed occurred not more than 8 years 
     before the effective date of the revision of the table; and
       ``(2) either--
       ``(A) the petition satisfies the conditions described in 
     subsection (a); or
       ``(B) the date of the occurrence of the first symptom or 
     manifestation of onset of the injury occurred more than 4 
     years before the petition is filed, and the petition is filed 
     not more than 2 years after the effective date of the 
     revision of the table.''.
       (c) Derivative Petitions.--Section 2116 of the Public 
     Health Service Act (42 U.S.C. 300aa-16) is amended by adding 
     at the end the following:
       ``(d) Derivative Petitions.--No derivative petition may be 
     filed for compensation under the Program later than 60 days 
     after the date on which the United States Court of Federal 
     Claims has entered final judgment and the time for all 
     further appeal or review has expired on the underlying claim 
     of the person who sustained the vaccine-related injury or 
     death upon which the derivative petition is premised.''.
       (d) Timely Resolutions of Claims.--
       (1) Special master decision.--Section 2112(d)(3)(A) of the 
     Public Health Service Act (42 U.S.C. 300aa-12(d)(3)(A)) is 
     amended by adding at the end the following: ``For purposes of 
     this subparagraph, the petition shall be deemed to be filed 
     on the date on which all petition contents and supporting 
     documents required under section 2111(c) and, when 
     applicable, section 2111(d) and the Vaccine Rules of the 
     United States Court of Federal Claims, such as an affidavit 
     and supporting documentation, are served on the Secretary and 
     filed with the clerk of the United States Court of Federal 
     Claims.''.
       (2) Court of federal claims decision.--Section 2121(b) of 
     the Public Health Service Act (42 U.S.C. 300aa-21(b)) is 
     amended by adding at the end the following: ``For purposes of 
     this subsection, the petition shall be deemed to be filed on 
     the date on which all petition contents and supporting 
     documents required under section 2111(c) and, when 
     applicable, section 2111(d) and the Vaccine Rules of the 
     United States Court of Federal Claims, such as an affidavit 
     and supporting documentation, are served on the Secretary and 
     filed with the clerk of the United States Court of Federal 
     Claims.''.

     SEC. __33. ADVISORY COMMISSION ON CHILDHOOD VACCINES.

       (a) Selection of Persons Injured by Vaccines as Public 
     Members.--Section 2119(a)(1)(B) of the Public Health Service 
     Act (42 U.S.C. 300aa-19(a)(1)(B)) is amended by striking ``of 
     whom'' and all that follows and inserting the following: ``of 
     whom 1 shall be the legal representative of a child who has 
     suffered a vaccine-related injury or death, and at least 1 
     other shall be either the legal representative of a child who 
     has suffered a vaccine-related injury or death or an 
     individual who has personally suffered a vaccine-related 
     injury.''.
       (b) Mandatory Meeting Schedule Eliminated.--Section 2119(c) 
     of the Public Health Service Act (42 U.S.C. 300aa-19(c)) is 
     amended by striking ``not less often than four times per year 
     and''.

     SEC. __34. CLARIFICATION OF STANDARDS OF RESPONSIBILITY.

       (a) General Rule.--Section 2122(a) of the Public Health 
     Service Act (42 U.S.C. 300aa-22(a)) is amended by striking 
     ``and (e) State law shall apply to a civil action brought for 
     damages'' and inserting ``(d), and (f) State law shall apply 
     to a civil action brought for damages or equitable relief''; 
     and
       (b) Unavoidable Adverse Side Effects.--Section 2122(b)(1) 
     of the Public Health Service Act (42 U.S.C. 300aa-22(b)(1)) 
     is amended by inserting ``or equitable relief'' after ``for 
     damages''.
       (c) Direct Warnings.--Section 2122(c) of the Public Health 
     Service Act (42 U.S.C. 300aa-22(c)) is amended by inserting 
     ``or equitable relief'' after ``for damages''.
       (d) Construction.--Section 2122(d) of the Public Health 
     Service Act (42 U.S.C. 300aa-22(d)) is amended--
       (1) by inserting ``or equitable relief'' after ``for 
     damages''; and
       (2) by inserting ``or relief'' after ``which damages''.
       (e) Past or Present Physical Injury.--Section 2122 of the 
     Public Health Service Act (42 U.S.C. 300aa-22) is amended--
       (1) by redesignating subsections (d) and (e) as subsections 
     (e) and (f), respectively; and
       (2) by inserting after subsection (c) the following:
       ``(d) Past or Present Physical Injury.--No vaccine 
     manufacturer or vaccine administrator shall be liable in a 
     civil action brought after October 1, 1988, for equitable or 
     monetary relief absent proof of past or present physical 
     injury from the administration of a vaccine, nor shall any 
     vaccine manufacturer or vaccine administrator be liable in 
     any such civil action for claims of medical monitoring, or 
     increased risk of harm.''.

     SEC. __35. CLARIFICATION OF DEFINITION OF MANUFACTURER.

       Section 2133(3) of the Public Health Service Act (42 U.S.C. 
     300aa-33(3)) is amended--
       (1) in the first sentence, by striking ``under its label 
     any vaccine set forth in the Vaccine Injury Table'' and 
     inserting ``any vaccine set forth in the Vaccine Injury 
     table, including any component or ingredient of any such 
     vaccine''; and
       (2) in the second sentence, by inserting ``including any 
     component or ingredient of any such vaccine'' before the 
     period.

     SEC. __36. CLARIFICATION OF DEFINITION OF VACCINE-RELATED 
                   INJURY OR DEATH.

       Section 2133(5) of the Public Health Service Act (42 U.S.C. 
     300aa-33(5)) is amended by adding at the end the following: 
     ``For purposes of the preceding sentence, an adulterant or 
     contaminant shall not include any component or ingredient 
     listed in a vaccine's product license application or product 
     label.''.

     SEC. __37. CLARIFICATION OF DEFINITION OF VACCINE.

       Section 2133 of the Public Health Service Act (42 U.S.C. 
     300aa-33) is amended by adding at the end the following:
       ``(7) The term `vaccine' means any preparation or 
     suspension, including a preparation or suspension containing 
     an attenuated or inactive microorganism or subunit thereof or 
     toxin, developed or administered to produce or enhance the 
     body's immune response to a disease or diseases and includes 
     all components and ingredients listed in the vaccines's 
     product license application and product label.''.

     SEC. __38. AMENDMENTS TO VACCINE INJURY COMPENSATION TRUST 
                   FUND.

       (a) Expansion of Compensated Loss.--Section 9510(c)(1)(A) 
     of the Internal Revenue Code of 1986 is amended by inserting 
     ``, or related loss,'' after ``death''.
       (b) Increase in Limit on Administrative Expenses.--
     Subparagraph (B) of section 9510(c)(1) of the Internal 
     Revenue Code of 1986 is amended--
       (1) by striking ``(but not in excess of the base amount of 
     $9,500,000 for any fiscal year)''; and
       (2) by striking the period and inserting ``, provided that 
     such administrative costs shall not exceed the greater of--
       ``(i) the base amount of $9,500,000,
       ``(ii) 125 percent of the base amount for any fiscal year 
     in which the total number of claims pending under such 
     subtitle exceeds 150 percent of the average number of claims 
     pending in the preceding 5 years,
       ``(iii) 175 percent of the base amount for any fiscal year 
     in which the total number of claims pending under such 
     subtitle exceeds 200 percent of the average number of claims 
     pending in the preceding 5 years,
       ``(iv) 225 percent of the base amount for any fiscal year 
     in which the total number of claims pending under such 
     subtitle exceeds 250 percent of the average number of claims 
     pending in the preceding 5 years, or
       ``(v) 275 percent of the base amount for any fiscal year in 
     which the total number of claims pending under such subtitle 
     exceeds 300 percent of the average number of claims pending 
     in the preceding 5 years.''.
       (c) Conforming Amendment.--Section 9510(c)(1)(A) of the 
     Internal Revenue Code of 1986 is amended by striking 
     ``October 18, 2000'' and inserting ``the date of enactment of 
     the Improved Vaccine Affordability and Availability Act''.

     SEC. __39. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.

       Part C of title XXI of the Public Health Service Act (42 
     U.S.C. 300a-25 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 2129. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.

       ``(a) In General.--Not later than 6 months after the date 
     of enactment of this section, the Secretary shall enter into 
     a contract with the Institute of Medicine of the National 
     Academy of Science under which the Institute shall conduct an 
     ongoing, comprehensive review of new scientific data on 
     childhood vaccines (according to priorities agreed upon from 
     time to time by the Secretary and the Institute of Medicine).
       ``(b) Reports.--Not later than 3 years after the date on 
     which the contract is entered into under subsection (a), the 
     Institute of

[[Page 15387]]

     Medicine shall submit to the Secretary a report on the 
     findings of studies conducted, including findings as to any 
     adverse events associated with childhood vaccines, including 
     conclusions concerning causation of adverse events by such 
     vaccines, and other appropriate recommendations, based on 
     such findings and conclusions.
       ``(c) Failure To Enter Into Contract.--If the Secretary and 
     the Institute of Medicine are unable to enter into the 
     contract described in subsection (a), the Secretary shall 
     enter into a contract with another qualified nongovernmental 
     scientific organization for the purposes described in 
     subsections (a) and (b).
       ``(d) Authorization of Appropriations.--To carry out this 
     section, there are authorized to be appropriated such sums as 
     may be necessary for each of fiscal years 2003, 2004, 2005 
     and 2006.''.

     SEC. __40. PENDING ACTIONS.

       The amendments made by this title shall apply to all 
     actions or proceedings pending on or after the date of 
     enactment of this Act, unless a court of competent 
     jurisdiction has entered judgment (regardless of whether the 
     time for appeal has expired) in such action or proceeding 
     disposing of the entire action or proceeding.

     SEC. __41. REPORT.

       Not later than 1 year after the date of enactment of this 
     Act, and annually thereafter, the Advisory Commission on 
     Childhood Vaccines shall report to the Secretary of Health 
     and Human Services regarding the status of the Vaccine Injury 
     Compensation Trust Fund, and shall make recommendations to 
     the Secretary regarding the allocation of funds from the 
     Vaccine Injury Compensation Trust Fund.
                                 ______
                                 
  SA 4344. Mr. FRIST submitted an amendment intended to be proposed to 
amendment SA 4299 proposed by Mr. Reid (for Mr. Dorgan (for himself, 
Mr. Wellstone, Mr. Jeffords, Ms. Stabenow, Ms. Collins, Mr. Levin, Mr. 
Johnson, Mr. Miller, Mr. Durbin, Mr. Feingold, and Mr. Harkin)) to the 
bill (S. 812) to amend the Federal Food, Drug, and Cosmetic Act to 
provide greater access to affordable pharmaceuticals; which was ordered 
to lie on the table; as follows:

       At the appropriate place, insert the following:

       TITLE __--IMPROVED VACCINE AFFORDABILITY AND AVAILABILITY

     SEC. __01. SHORT TITLE.

       This title may be cited as the ``Improved Vaccine 
     Affordability and Availability Act''.

                    Subtitle A--State Vaccine Grants

     SEC. __11. AVAILABILITY OF INFLUENZA VACCINE.

       Section 317(j) of the Public Health Service Act (42 U.S.C. 
     247b(j)) is amended by adding at the end the following:
       ``(3)(A) For the purpose of carrying out activities 
     relating to influenza vaccine under the immunization program 
     under this subsection, there are authorized to be 
     appropriated such sums as may be necessary for each of fiscal 
     years 2003 and 2004. Such authorization shall be in addition 
     to amounts available under paragraphs (1) and (2) for such 
     purpose.
       ``(B) The authorization of appropriations established in 
     subparagraph (A) shall not be effective for a fiscal year 
     unless the total amount appropriated under paragraphs (1) and 
     (2) for the fiscal year is not less than such total for 
     fiscal year 2000.
       ``(C) The purposes for which amounts appropriated under 
     subparagraph (A) are available to the Secretary include 
     providing for improved State and local infrastructure for 
     influenza immunizations under this subsection in accordance 
     with the following:
       ``(i) Increasing influenza immunization rates in 
     populations considered by the Secretary to be at high risk 
     for influenza-related complications and in their contacts.
       ``(ii) Recommending that health care providers actively 
     target influenza vaccine that is available in September, 
     October, and November to individuals who are at increased 
     risk for influenza-related complications and to their 
     contacts.
       ``(iii) Providing for the continued availability of 
     influenza immunizations through December of such year, and 
     for additional periods to the extent that influenza vaccine 
     remains available.
       ``(iv) Encouraging States, as appropriate, to develop 
     contingency plans (including plans for public and 
     professional educational activities) for maximizing influenza 
     immunizations for high-risk populations in the event of a 
     delay or shortage of influenza vaccine.
       ``(D) The Secretary shall submit to the Committee on Energy 
     and Commerce of the House of Representatives, and the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate, periodic reports describing the activities of the 
     Secretary under this subsection regarding influenza vaccine. 
     The first such report shall be submitted not later than June 
     6, 2003, the second report shall be submitted not later than 
     June 6, 2004, and subsequent reports shall be submitted 
     biennially thereafter.''.

     SEC. __12. PROGRAM FOR INCREASING IMMUNIZATION RATES FOR 
                   ADULTS AND ADOLESCENTS; COLLECTION OF 
                   ADDITIONAL IMMUNIZATION DATA.

       (a) Activities of Centers for Disease Control and 
     Prevention.--Section 317(j) of the Public Health Service Act 
     (42 U.S.C. 247b(j)), as amended by section __11, is further 
     amended by adding at the end the following:
       ``(4)(A) For the purpose of carrying out activities to 
     increase immunization rates for adults and adolescents 
     through the immunization program under this subsection, and 
     for the purpose of carrying out subsection (k)(2), there are 
     authorized to be appropriated $50,000,000 for fiscal year 
     2003, and such sums as may be necessary for each of the 
     fiscal years 2004 through 2006. Such authorization is in 
     addition to amounts available under paragraphs (1), (2), and 
     (3) for such purposes.
       ``(B) In expending amounts appropriated under subparagraph 
     (A), the Secretary shall give priority to adults and 
     adolescents who are medically underserved and are at risk for 
     vaccine-preventable diseases, including as appropriate 
     populations identified through projects under subsection 
     (k)(2)(E).
       ``(C) The purposes for which amounts appropriated under 
     subparagraph (A) are available include (with respect to 
     immunizations for adults and adolescents) the payment of the 
     costs of storing vaccines, outreach activities to inform 
     individuals of the availability of the immunizations, and 
     other program expenses necessary for the establishment or 
     operation of immunization programs carried out or supported 
     by States or other public entities pursuant to this 
     subsection.
       ``(5) The Secretary shall annually submit to Congress a 
     report that--
       ``(A) evaluates the extent to which the immunization system 
     in the United States has been effective in providing for 
     adequate immunization rates for adults and adolescents, 
     taking into account the applicable year 2010 health 
     objectives established by the Secretary regarding the health 
     status of the people of the United States; and
       ``(B) describes any issues identified by the Secretary that 
     may affect such rates.
       ``(6) In carrying out this subsection and paragraphs (1) 
     and (2) of subsection (k), the Secretary shall consider 
     recommendations regarding immunizations that are made in 
     reports issued by the Institute of Medicine.''.
       (b) Research, Demonstrations, and Education.--Section 
     317(k) of the Public Health Service Act (42 U.S.C. 247b(k)) 
     is amended--
       (1) by redesignating paragraphs (2) through (4) as 
     paragraphs (3) through (5), respectively; and
       (2) by inserting after paragraph (1) the following:
       ``(2) The Secretary, directly and through grants under 
     paragraph (1), shall provide for a program of research, 
     demonstration projects, and education in accordance with the 
     following:
       ``(A) The Secretary shall coordinate with public and 
     private entities (including nonprofit private entities), and 
     develop and disseminate guidelines, toward the goal of 
     ensuring that immunizations are routinely offered to adults 
     and adolescents by public and private health care providers.
       ``(B) The Secretary shall cooperate with public and private 
     entities to obtain information for the annual evaluations 
     required in subsection (j)(5)(A).
       ``(C) The Secretary shall (relative to fiscal year 2001) 
     increase the extent to which the Secretary collects data on 
     the incidence, prevalence, and circumstances of diseases and 
     adverse events that are experienced by adults and adolescents 
     and may be associated with immunizations, including 
     collecting data in cooperation with commercial laboratories.
       ``(D) The Secretary shall ensure that the entities with 
     which the Secretary cooperates for purposes of subparagraphs 
     (A) through (C) include managed care organizations, 
     community-based organizations that provide health services, 
     and other health care providers.
       ``(E) The Secretary shall provide for projects to identify 
     racial and ethnic minority groups and other health disparity 
     populations for which immunization rates for adults and 
     adolescents are below such rates for the general population, 
     and to determine the factors underlying such disparities.''.

     SEC. __13. IMMUNIZATION AWARENESS.

       (a) Development of Information Concerning Meningitis.--
       (1) In general.--The Secretary of Health and Human 
     Services, in consultation with the Director of the Centers 
     for Disease Control and Prevention, shall develop and make 
     available to entities described in paragraph (2) information 
     concerning bacterial meningitis and the availability and 
     effectiveness of vaccinations for populations targeted by the 
     Advisory Committee on Immunization Practices (an advisory 
     committee established by the Secretary of Health and Human 
     Services, acting through the Centers for Disease Control and 
     Prevention).
       (2) Entities.--An entity is described in this paragraph if 
     the entity--
       (A) is--
       (i) a college or university; or
       (ii) any other facility with a setting similar to a 
     dormitory that houses age-appropriate populations for whom 
     the Advisory Committee on Immunization Practices recommends 
     such a vaccination; and

[[Page 15388]]

       (B) is determined appropriate by the Secretary of Health 
     and Human Services.
       (b) Development of Information Concerning Hepatitis.--
       (1) In general.--The Secretary of Health and Human 
     Services, in consultation with the Director of the Centers 
     for Disease Control and Prevention, shall develop and make 
     available to entities described in paragraph (2) information 
     concerning hepatitis A and B and the availability and 
     effectiveness of vaccinations with respect to such diseases.
       (2) Entities.--An entity is described in this paragraph if 
     the entity--
       (A) is--
       (i) a health care clinic that serves individuals diagnosed 
     as being infected with HIV or as having other sexually 
     transmitted diseases;
       (ii) an organization or business that counsels individuals 
     about international travel or who arranges for such travel;
       (iii) a police, fire or emergency medical services 
     organization that responds to natural or man-made disasters 
     or emergencies;
       (iv) a prison or other detention facility;
       (v) a college or university; or
       (vi) a public health authority or children's health service 
     provider in areas of intermediate or high endemicity for 
     hepatitis A as defined by the Centers for Disease Control and 
     Prevention; and
       (B) is determined appropriate by the Secretary of Health 
     and Human Services.

     SEC. __14. SUPPLY OF VACCINES.

       (a) In General.--The Secretary of Health and Human 
     Services, acting through the Director of the Centers for 
     Disease Control and Prevention, shall prioritize, acquire, 
     and maintain a supply of such prioritized vaccines sufficient 
     to provide vaccinations throughout a 6-month period.
       (b) Proceeds.--Any proceeds received by the Secretary of 
     Health and Human Services from the sale of vaccines contained 
     in the supply described in subsection (a), shall be available 
     to the Secretary for the purpose of purchasing additional 
     vaccines for the supply. Such proceeds shall remain available 
     until expended.
       (c) Authorization of Appropriations.--There are authorized 
     to be appropriated for the purpose of carrying out subsection 
     (a) such sums as may be necessary for each of fiscal years 
     2003 through 2008.

            Subtitle B--Vaccine Injury Compensation Program

     SEC. __21. ADMINISTRATIVE REVISION OF VACCINE INJURY TABLE.

       Section 2114 of the Public Health Service Act (42 U.S.C. 
     300aa-14) is amended--
       (1) in subsection (c), by striking paragraph (1) and 
     inserting the following:
       ``(1) The Secretary may promulgate regulations to modify in 
     accordance with paragraph (3) the Vaccine Injury Table. In 
     promulgating such regulations, the Secretary shall provide 
     for notice and for at least 60 days opportunity for public 
     comment.''; and
       (2) in subsection (d), by striking ``90 days'' and 
     inserting ``60 days''.

     SEC. __22. EQUITABLE RELIEF.

       Section 2111(a)(2)(A) of the Public Health Service Act (42 
     U.S.C. 300aa-11(a)(2)(A)) is amended by striking ``No 
     person'' and all that follows through ``and--'' and inserting 
     the following: ``No person may bring or maintain a civil 
     action against a vaccine administrator or manufacturer in a 
     State or Federal court for damages arising from, or equitable 
     relief relating to, a vaccine-related injury or death 
     associated with the administration of a vaccine after October 
     1, 1988 and no such court may award damages or equitable 
     relief for any such vaccine-related injury or death, unless 
     the person proves past or present physical injury and a 
     timely petition has been filed, in accordance with section 
     2116 for compensation under the Program for such injury or 
     death and--''.

     SEC. __23. PARENT OR OTHER THIRD PARTY PETITIONS FOR 
                   COMPENSATION.

       (a) Limitations on Derivative Petitions.--Section 
     2111(a)(2) of the Public Health Service Act (42 U.S.C. 300aa-
     11(a)(2)) is amended--
       (1) in subparagraph (B), by inserting ``or (B)'' after 
     ``subparagraph (A)'';
       (2) by redesignating subparagraph (B) as subparagraph (C); 
     and
       (3) by inserting after subparagraph (A) the following:
       ``(B)(i) No parent, legal guardian, or spouse (referred to 
     in this title as a parent or other third party) may bring or 
     maintain a civil action against a vaccine administrator or 
     manufacturer in a Federal or State court for damages or 
     equitable relief relating to a vaccine-related injury or 
     death, including damages for loss of consortium, society, 
     companionship, or services, loss of earnings, medical or 
     other expenses, and emotional distress, and no court may 
     award damages or equitable relief in such an action, unless--
       ``(I) the person who sustained the underlying vaccine-
     related injury or death upon which such parent's or other 
     third party's claim is premised has, in accordance with 
     section 2112, been awarded compensation in a final judgment 
     of the United States Court of Federal Claims and such 
     judgment is subject to no further appeal or review;
       ``(II) such parent or other third party timely filed a 
     derivative petition, in accordance with section 2116; and
       ``(III)(aa) the United States Court of Federal Claims has 
     issued judgment under section 2112 on the derivative 
     petition, and such parent or other third party elects under 
     section 2121(a) to file a civil action; or
       ``(bb) such parent or other third party elects to withdraw 
     such derivative petition under section 2121(b) or such 
     petition is considered withdrawn under such section.
       ``(ii) Any civil action brought in accordance with this 
     subparagraph shall be subject to the standards and procedures 
     set forth in sections 2122 and 2123, regardless of whether 
     the action arises directly from a vaccine-related injury or 
     death associated with the administration of a vaccine. In a 
     case in which the person who sustained the underlying 
     vaccine-related injury or death upon which such parent's or 
     other third party's civil action is premised elects under 
     section 2121(a) to receive the compensation awarded, such 
     parent or other third party may not bring a civil action for 
     damages or equitable relief, and no court may award damages 
     or equitable relief, for any injury or loss of the type set 
     forth in section 2115(a) or that might in any way overlap 
     with or otherwise duplicate compensation of the type 
     available under section 2115(a).''.
       (b) Eligible Persons.--Section 2111(a)(9) of the Public 
     Health Service Act (42 U.S.C. 300aa-11(a)(9)) is amended by 
     striking the period and inserting ``and to a parent or other 
     third party to the extent such parent or other third party 
     seeks damages or equitable relief relating to a vaccine-
     related injury or death sustained by a person who is 
     qualified to file a petition for compensation under the 
     Program.''.
       (c) Petitioners.--Section 2111(b) of the Public Health 
     Service Act (42 U.S.C. 300aa-11(b)) is amended--
       (1) in paragraph (1)--
       (A) in subparagraph (A), by striking ``(B)'' and inserting 
     ``(C)'';
       (B) by redesignating subparagraph (B) as subparagraph (C); 
     and
       (C) by inserting after subparagraph (A) the following:
       ``(B) Except as provided in subparagraph (C), any parent or 
     other third party with respect to a person--
       ``(i) who has sustained a vaccine-related injury or death;
       ``(ii) who has filed a petition for compensation under the 
     Program (or whose legal representative has filed such a 
     petition as authorized in subparagraph (A)); and
       ``(iii) who has, in accordance with section 2112, been 
     awarded compensation in a final judgment of the United States 
     Court of Federal Claims that is subject to no further appeal 
     or review;

     may, if such parent or other third party meets the 
     requirements of subsection (d), file a derivative petition 
     under this section.''; and
       (2) in paragraph (2)--
       (A) by inserting ``by or on behalf of the person who 
     sustained the vaccine-related injury or death'' after 
     ``filed''; and
       (B) by adding at the end the following: ``A parent or other 
     third party may file only 1 derivative petition with respect 
     to each administration of a vaccine.''.
       (d) Derivative Petition Contents.--Section 2111 of the 
     Public Health Service Act (42 U.S.C. 300aa-11) is amended--
       (1) by redesignating subsections (d) and (e) as subsections 
     (e) and (f), respectively; and
       (2) by inserting after subsection (c) the following:
       ``(d) Derivative Petitions.--
       ``(1) If the parent or other third party with respect to 
     the person who sustained the vaccine-related injury or death 
     seeks compensation under the Program, such parent or other 
     third party shall file a timely derivative petition for 
     compensation under the Program in accordance with this 
     section.
       ``(2) Such a derivative petition shall contain--
       ``(A) except for records that are unavailable as described 
     in subsection (c)(3), an affidavit, and supporting 
     documentation, demonstrating that--
       ``(i) such person was, in accordance with section 2112, 
     previously awarded compensation for the underlying vaccine-
     related injury or death upon which such parent's or other 
     third party's derivative petition is premised in a final 
     judgment of the United States Court of Federal Claims and 
     such judgment is subject to no further appeal or review;
       ``(ii) the derivative petition was filed not later than 60 
     days after the date on which such judgment became final and 
     subject to no further appeal or review;
       ``(iii) such parent or other third party suffered a loss 
     compensable under section 2115(b) as a result of the vaccine-
     related injury or death sustained by such person; and
       ``(iv) such parent or other third party has not previously 
     collected an award or settlement of a civil action for 
     damages for such loss; and
       ``(B) records establishing such parent's or other third 
     party's relationship to the person who sustained the vaccine-
     related injury or death.''.
       (e) Determination of Eligibility for Compensation.--Section 
     2113(a)(1) of the Public Health Service Act (42 U.S.C. 300aa-
     13(a)(1)) is amended--

[[Page 15389]]

       (1) in subparagraph (A), by inserting ``or, as applicable, 
     section 2111(d)'' before the comma; and
       (2) in subparagraph (B), by inserting ``or, as applicable, 
     that the injury or loss described in the derivative petition 
     is due to factors unrelated to the vaccine-related injury or 
     death'' after ``the petition''.
       (f) Compensation.--Section 2115 of the Public Health 
     Service Act (42 U.S.C. 300aa-15) is amended--
       (1) by redesignating subsections (b) through (j) as 
     subsections (c) through (k), respectively;
       (2) by inserting after subsection (a) the following:
       ``(b) Derivative Petitions.--Compensation awarded under the 
     Program to a parent or other third party who files a 
     derivative petition under section 2111 for a loss sustained 
     as a result of a vaccine-related injury or death sustained by 
     the injured party shall include compensation, if any, for 
     loss of consortium, society, companionship, or services, in 
     an amount not to exceed the lesser of $250,000 or the total 
     amount of compensation awarded to the person who sustained 
     the underlying vaccine-related injury or death.'';
       (3) in subsection (e)(2), as so redesignated by paragraph 
     (1)--
       (A) by striking ``(2) and (3)'' and inserting ``(2), (3), 
     and (4)''; and
       (B) by inserting ``and subsection (b),'' after ``(a),'';
       (4) in subsection (g), as so redesignated by paragraph (1), 
     in paragraph (4)(B), by striking ``subsection (j)'' and 
     inserting ``subsection (k)'';
       (5) in subsection (j), as so redesignated by paragraph 
     (1)--
       (A) in paragraph (1), by striking ``subsection (j)'' and 
     inserting ``subsection (k)''; and
       (B) in paragraph (2), by inserting ``, or to a parent or 
     other third party with respect to a person who sustained a 
     vaccine-related injury or death,'' after ``death''; and
       (6) in subsection (k), as so redesignated by paragraph (1), 
     by striking ``subsection (f)(4)(B)'' and inserting 
     ``subsection (g)(4)(B)''.

     SEC. __24. JURISDICTION TO DISMISS ACTIONS IMPROPERLY 
                   BROUGHT.

       Section 2111(a)(3) of the Public Health Service Act (42 
     U.S.C. 300aa-11(a)(3)) is amended by adding at the end the 
     following: ``If any civil action which is barred under 
     subparagraph (A) or (B) of paragraph (2) is filed or 
     maintained in a State court, or any vaccine administrator or 
     manufacturer is made a party to any civil action brought in 
     State court (other than a civil action which may be brought 
     under paragraph (2)) for damages or equitable relief for a 
     vaccine-related injury or death associated with the 
     administration of a vaccine after October 1, 1988, the civil 
     action may be removed by the defendant or defendants to the 
     United States Court of Federal Claims, which shall have 
     jurisdiction over such civil action, and which shall dismiss 
     such action. The notice required by section 1446 of title 28, 
     United States Code, shall be filed with the United States 
     Court of Federal Claims, and that court shall proceed in 
     accordance with sections 1446 through 1451 of title 28, 
     United States Code.''.

     SEC. __25. APPLICATION.

       Section 2111(a)(9) of the Public Health Service Act (42 
     U.S.C. 300aa-11(a)(9)) is amended by striking ``This'' and 
     inserting ``Except as provided in paragraph (2), this''.

     SEC. __26. CLARIFICATION OF WHEN INJURY IS CAUSED BY FACTOR 
                   UNRELATED TO ADMINISTRATION OF VACCINE.

       Section 2113(a)(2)(B) of the Public Health Service Act (42 
     U.S.C. 300aa-13(a)(2)(B)) is amended--
       (1) by inserting ``structural lesions, genetic disorders,'' 
     after ``and related anoxia),'';
       (2) by inserting ``(without regard to whether the cause of 
     the infection, toxin, trauma, structural lesion, genetic 
     disorder, or metabolic disturbance is known)'' after 
     ``metabolic disturbances''; and
       (3) by striking ``but'' and inserting ``and''.

     SEC. __27. INCREASE IN AWARD IN THE CASE OF A VACCINE-RELATED 
                   DEATH AND FOR PAIN AND SUFFERING.

       Section 2115(a) of the Public Health Service Act (42 U.S.C. 
     300aa-15(a)) is amended--
       (1) in paragraph (2), by striking ``$250,000'' and 
     inserting ``$350,000''; and
       (2) in paragraph (4), by striking ``$250,000'' and 
     inserting ``$350,000''.

     SEC. __28. BASIS FOR CALCULATING PROJECTED LOST EARNINGS.

       Section 2115(a)(3)(B) of the Public Health Service Act (42 
     U.S.C. 300aa-15(a)(3)(B)) is amended by striking ``loss of 
     earnings'' and all that follows and inserting the following: 
     ``loss of earnings determined on the basis of the annual 
     estimate of the average (mean) gross weekly earnings of wage 
     and salary workers age 18 and over (excluding the 
     incorporated self-employed) in the private non-farm sector 
     (which includes all industries other than agricultural 
     production crops and livestock), as calculated annually by 
     the Bureau of Labor Statistics from the quarter sample data 
     of the Current Population Survey, or as calculated by such 
     similar method as the Secretary may prescribe by regulation, 
     less appropriate taxes and the average cost of a health 
     insurance policy, as determined by the Secretary.''.

     SEC. __29. ALLOWING COMPENSATION FOR FAMILY COUNSELING 
                   EXPENSES AND EXPENSES OF ESTABLISHING 
                   GUARDIANSHIP.

       (a) Family Counseling Expenses in Post-1988 Cases.--Section 
     2115(a) of the Public Health Service Act (42 U.S.C. 300aa-
     15(a)) is amended by adding at the end to following:
       ``(5) Actual unreimbursable expenses that have been or will 
     be incurred for family counseling as is determined to be 
     reasonably necessary and that result from the vaccine-related 
     injury from which the petitioner seeks compensation.''.
       (b) Expenses of Establishing Guardianships in Post-1988 
     Cases.--Section 2115(a) of the Public Health Service Act (42 
     U.S.C. 300aa-15(a)), as amended by subsection (a), is further 
     amended by adding at the end the following:
       ``(6) Actual unreimbursable expenses that have been, or 
     will be reasonably incurred to establish and maintain a 
     guardianship or conservatorship for an individual who has 
     suffered a vaccine-related injury, including attorney fees 
     and other costs incurred in a proceeding to establish and 
     maintain such guardianship or conservatorship.''.
       (c) Conforming Amendment for Cases From 1988 and Earlier.--
     Section 2115 of the Public Health Service Act (42 U.S.C. 
     300aa-15) is amended in subsection (c), as so redesignated by 
     section __23(f)--
       (1) in paragraph (2), by striking ``and'' at the end;
       (2) in paragraph (3), by striking ``(e)'' and inserting 
     ``(f))'';
       (3) by redesignating paragraph (3) as paragraph (5); and
       (4) by inserting after paragraph (2), the following:
       ``(3) family counseling expenses (as provided for in 
     paragraph (5) of subsection (a));
       ``(4) expenses of establishing guardianships (as provided 
     for in paragraph (6) of subsection (a)); and''.

     SEC. __30. ALLOWING PAYMENT OF INTERIM COSTS.

       Section 2115 of the Public Health Service Act (42 U.S.C. 
     300aa-15) is amended in subsection (f), as so redesignated by 
     section __23(f), by adding at the end the following:
       ``(4) A special master or court may make an interim award 
     of costs if--
       ``(A) the case involves a vaccine administered on or after 
     October 1, 1988;
       ``(B) the special master or court has determined whether or 
     not the petitioner is entitled to compensation under the 
     Program;
       ``(C) the award is limited to other costs (within the 
     meaning of paragraph (1)(B)) incurred in the proceeding; and
       ``(D) the petitioner provides documentation verifying the 
     expenditure of the amount for which compensation is 
     sought.''.

     SEC. __31. PROCEDURE FOR PAYING ATTORNEYS' FEES.

       Section 2115 of the Public Health Service Act (42 U.S.C. 
     300aa-15), is amended in subsection (f), as so redesignated 
     by section __23(f) and amended by section __30, by adding at 
     the end the following:
       ``(5) When a special master or court awards attorney fees 
     or costs under paragraph (1) or (4), it may order that such 
     fees or costs be payable solely to the petitioner's attorney 
     if--
       ``(A) the petitioner expressly consents; or
       ``(B) the special master or court determines, after 
     affording to the Secretary and to all interested persons the 
     opportunity to submit relevant information, that--
       ``(i) the petitioner cannot be located or refuses to 
     respond to a request by the special master or court for 
     information, and there is no practical alternative means to 
     ensure that the attorney will be reimbursed for such fees or 
     costs expeditiously; or
       ``(ii) there are otherwise exceptional circumstances and 
     good cause for paying such fees or costs solely to the 
     petitioner's attorney.''.

     SEC. __32. EXTENSION OF STATUTE OF LIMITATIONS.

       (a) General Rule.--Section 2116(a) of the Public Health 
     Service Act (42 U.S.C. 300aa-16(a)) is amended--
       (1) in paragraph (2) by striking ``36 months'' and 
     inserting ``6 years''; and
       (2) in paragraph (3), by striking ``48 months'' and 
     inserting ``6 years''.
       (b) Claims Based on Revisions to Table.--Section 2116 of 
     the Public Health Service Act (42 U.S.C. 300aa-16) is amended 
     by striking subsection (b) and inserting the following:
       ``(b) Effect of Revised Table.--If at any time the Vaccine 
     Injury Table is revised and the effect of such revision is to 
     make an individual eligible for compensation under the 
     program, where, before such revision, such individual was not 
     eligible for compensation under the program, or to 
     significantly increase the likelihood that an individual will 
     be able to obtain compensation under the program, such person 
     may, and shall before filing a civil action for equitable 
     relief or monetary damages, notwithstanding section 
     2111(b)(2), file a petition for such compensation if--
       ``(1) the vaccine-related death or injury with respect to 
     which the petition is filed occurred not more than 8 years 
     before the effective date of the revision of the table; and
       ``(2) either--
       ``(A) the petition satisfies the conditions described in 
     subsection (a); or

[[Page 15390]]

       ``(B) the date of the occurrence of the first symptom or 
     manifestation of onset of the injury occurred more than 4 
     years before the petition is filed, and the petition is filed 
     not more than 2 years after the effective date of the 
     revision of the table.''.
       (c) Derivative Petitions.--Section 2116 of the Public 
     Health Service Act (42 U.S.C. 300aa-16) is amended by adding 
     at the end the following:
       ``(d) Derivative Petitions.--No derivative petition may be 
     filed for compensation under the Program later than 60 days 
     after the date on which the United States Court of Federal 
     Claims has entered final judgment and the time for all 
     further appeal or review has expired on the underlying claim 
     of the person who sustained the vaccine-related injury or 
     death upon which the derivative petition is premised.''.
       (d) Timely Resolutions of Claims.--
       (1) Special master decision.--Section 2112(d)(3)(A) of the 
     Public Health Service Act (42 U.S.C. 300aa-12(d)(3)(A)) is 
     amended by adding at the end the following: ``For purposes of 
     this subparagraph, the petition shall be deemed to be filed 
     on the date on which all petition contents and supporting 
     documents required under section 2111(c) and, when 
     applicable, section 2111(d) and the Vaccine Rules of the 
     United States Court of Federal Claims, such as an affidavit 
     and supporting documentation, are served on the Secretary and 
     filed with the clerk of the United States Court of Federal 
     Claims.''.
       (2) Court of federal claims decision.--Section 2121(b) of 
     the Public Health Service Act (42 U.S.C. 300aa-21(b)) is 
     amended by adding at the end the following: ``For purposes of 
     this subsection, the petition shall be deemed to be filed on 
     the date on which all petition contents and supporting 
     documents required under section 2111(c) and, when 
     applicable, section 2111(d) and the Vaccine Rules of the 
     United States Court of Federal Claims, such as an affidavit 
     and supporting documentation, are served on the Secretary and 
     filed with the clerk of the United States Court of Federal 
     Claims.''.

     SEC. __33. ADVISORY COMMISSION ON CHILDHOOD VACCINES.

       (a) Selection of Persons Injured by Vaccines as Public 
     Members.--Section 2119(a)(1)(B) of the Public Health Service 
     Act (42 U.S.C. 300aa-19(a)(1)(B)) is amended by striking ``of 
     whom'' and all that follows and inserting the following: ``of 
     whom 1 shall be the legal representative of a child who has 
     suffered a vaccine-related injury or death, and at least 1 
     other shall be either the legal representative of a child who 
     has suffered a vaccine-related injury or death or an 
     individual who has personally suffered a vaccine-related 
     injury.''.
       (b) Mandatory Meeting Schedule Eliminated.--Section 2119(c) 
     of the Public Health Service Act (42 U.S.C. 300aa-19(c)) is 
     amended by striking ``not less often than four times per year 
     and''.

     SEC. __34. CLARIFICATION OF STANDARDS OF RESPONSIBILITY.

       (a) General Rule.--Section 2122(a) of the Public Health 
     Service Act (42 U.S.C. 300aa-22(a)) is amended by striking 
     ``and (e) State law shall apply to a civil action brought for 
     damages'' and inserting ``(d), and (f) State law shall apply 
     to a civil action brought for damages or equitable relief''; 
     and
       (b) Unavoidable Adverse Side Effects.--Section 2122(b)(1) 
     of the Public Health Service Act (42 U.S.C. 300aa-22(b)(1)) 
     is amended by inserting ``or equitable relief'' after ``for 
     damages''.
       (c) Direct Warnings.--Section 2122(c) of the Public Health 
     Service Act (42 U.S.C. 300aa-22(c)) is amended by inserting 
     ``or equitable relief'' after ``for damages''.
       (d) Construction.--Section 2122(d) of the Public Health 
     Service Act (42 U.S.C. 300aa-22(d)) is amended--
       (1) by inserting ``or equitable relief'' after ``for 
     damages''; and
       (2) by inserting ``or relief'' after ``which damages''.
       (e) Past or Present Physical Injury.--Section 2122 of the 
     Public Health Service Act (42 U.S.C. 300aa-22) is amended--
       (1) by redesignating subsections (d) and (e) as subsections 
     (e) and (f), respectively; and
       (2) by inserting after subsection (c) the following:
       ``(d) Past or Present Physical Injury.--No vaccine 
     manufacturer or vaccine administrator shall be liable in a 
     civil action brought after October 1, 1988, for equitable or 
     monetary relief absent proof of past or present physical 
     injury from the administration of a vaccine, nor shall any 
     vaccine manufacturer or vaccine administrator be liable in 
     any such civil action for claims of medical monitoring, or 
     increased risk of harm.''.

     SEC. __35. CLARIFICATION OF DEFINITION OF MANUFACTURER.

       Section 2133(3) of the Public Health Service Act (42 U.S.C. 
     300aa-33(3)) is amended--
       (1) in the first sentence, by striking ``under its label 
     any vaccine set forth in the Vaccine Injury Table'' and 
     inserting ``any vaccine set forth in the Vaccine Injury 
     table, including any component or ingredient of any such 
     vaccine''; and
       (2) in the second sentence, by inserting ``including any 
     component or ingredient of any such vaccine'' before the 
     period.

     SEC. __36. CLARIFICATION OF DEFINITION OF VACCINE-RELATED 
                   INJURY OR DEATH.

       Section 2133(5) of the Public Health Service Act (42 U.S.C. 
     300aa-33(5)) is amended by adding at the end the following: 
     ``For purposes of the preceding sentence, an adulterant or 
     contaminant shall not include any component or ingredient 
     listed in a vaccine's product license application or product 
     label.''.

     SEC. __37. CLARIFICATION OF DEFINITION OF VACCINE.

       Section 2133 of the Public Health Service Act (42 U.S.C. 
     300aa-33) is amended by adding at the end the following:
       ``(7) The term `vaccine' means any preparation or 
     suspension, including a preparation or suspension containing 
     an attenuated or inactive microorganism or subunit thereof or 
     toxin, developed or administered to produce or enhance the 
     body's immune response to a disease or diseases and includes 
     all components and ingredients listed in the vaccines's 
     product license application and product label.''.

     SEC. __38. AMENDMENTS TO VACCINE INJURY COMPENSATION TRUST 
                   FUND.

       (a) Expansion of Compensated Loss.--Section 9510(c)(1)(A) 
     of the Internal Revenue Code of 1986 is amended by inserting 
     ``, or related loss,'' after ``death''.
       (b) Increase in Limit on Administrative Expenses.--
     Subparagraph (B) of section 9510(c)(1) of the Internal 
     Revenue Code of 1986 is amended--
       (1) by striking ``(but not in excess of the base amount of 
     $9,500,000 for any fiscal year)''; and
       (2) by striking the period and inserting ``, provided that 
     such administrative costs shall not exceed the greater of--
       ``(i) the base amount of $9,500,000,
       ``(ii) 125 percent of the base amount for any fiscal year 
     in which the total number of claims pending under such 
     subtitle exceeds 150 percent of the average number of claims 
     pending in the preceding 5 years,
       ``(iii) 175 percent of the base amount for any fiscal year 
     in which the total number of claims pending under such 
     subtitle exceeds 200 percent of the average number of claims 
     pending in the preceding 5 years,
       ``(iv) 225 percent of the base amount for any fiscal year 
     in which the total number of claims pending under such 
     subtitle exceeds 250 percent of the average number of claims 
     pending in the preceding 5 years, or
       ``(v) 275 percent of the base amount for any fiscal year in 
     which the total number of claims pending under such subtitle 
     exceeds 300 percent of the average number of claims pending 
     in the preceding 5 years.''.
       (c) Conforming Amendment.--Section 9510(c)(1)(A) of the 
     Internal Revenue Code of 1986 is amended by striking 
     ``October 18, 2000'' and inserting ``the date of enactment of 
     the Improved Vaccine Affordability and Availability Act''.

     SEC. __39. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.

       Part C of title XXI of the Public Health Service Act (42 
     U.S.C. 300a-25 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 2129. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.

       ``(a) In General.--Not later than 6 months after the date 
     of enactment of this section, the Secretary shall enter into 
     a contract with the Institute of Medicine of the National 
     Academy of Science under which the Institute shall conduct an 
     ongoing, comprehensive review of new scientific data on 
     childhood vaccines (according to priorities agreed upon from 
     time to time by the Secretary and the Institute of Medicine).
       ``(b) Reports.--Not later than 3 years after the date on 
     which the contract is entered into under subsection (a), the 
     Institute of Medicine shall submit to the Secretary a report 
     on the findings of studies conducted, including findings as 
     to any adverse events associated with childhood vaccines, 
     including conclusions concerning causation of adverse events 
     by such vaccines, and other appropriate recommendations, 
     based on such findings and conclusions.
       ``(c) Failure To Enter Into Contract.--If the Secretary and 
     the Institute of Medicine are unable to enter into the 
     contract described in subsection (a), the Secretary shall 
     enter into a contract with another qualified nongovernmental 
     scientific organization for the purposes described in 
     subsections (a) and (b).
       ``(d) Authorization of Appropriations.--To carry out this 
     section, there are authorized to be appropriated such sums as 
     may be necessary for each of fiscal years 2003, 2004, 2005 
     and 2006.''.

     SEC. __40. PENDING ACTIONS.

       The amendments made by this title shall apply to all 
     actions or proceedings pending on or after the date of 
     enactment of this Act, unless a court of competent 
     jurisdiction has entered judgment (regardless of whether the 
     time for appeal has expired) in such action or proceeding 
     disposing of the entire action or proceeding.

     SEC. __41. REPORT.

       Not later than 1 year after the date of enactment of this 
     Act, and annually thereafter, the Advisory Commission on 
     Childhood Vaccines shall report to the Secretary of Health 
     and Human Services regarding the status of the Vaccine Injury 
     Compensation Trust Fund, and shall make recommendations to 
     the Secretary regarding the allocation of funds from the 
     Vaccine Injury Compensation Trust Fund.

[[Page 15391]]


                                 ______
                                 
  SA 4345. Mr. GRAHAM (for himself, Mr. Smith of Oregon, Mr. Miller, 
Mrs. Lincoln, Mr. Bingaman, Mr. Kennedy, and Ms. Stabenow) proposed an 
amendment to amendment SA 4299 proposed by Mr. REID (for Mr. Dorgan 
(for himself, Mr. Wellstone, Mr. Jeffords, Ms. Stabenow, Ms. Collins, 
Mr. Levin, Mr. Johnson, Mr. Miller, Mr. Durbin, Mr. Feingold, and Mr. 
Harkin)) to the bill (S. 812) to amend the Federal Food, Drug, and 
Cosmetic Act to provide greater access to affordable pharmaceuticals; 
as follows:

       At the end, add the following:

    TITLE II--MEDICARE OUTPATIENT PRESCRIPTION DRUG BENEFIT PROGRAM

     SEC. 201. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This title may be cited as the ``Medicare 
     Prescription Drug Cost Protection Act of 2002''.
       (b) Table of Contents.--The table of contents of this title 
     is as follows:

Sec. 201. Short title; table of contents.
Sec. 202. 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. No premium for enrollment.
``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. 203. Part D benefits under Medicare+Choice plans.
Sec. 204. Additional assistance for low-income beneficiaries.
Sec. 205. Medigap revisions.
Sec. 206. Comprehensive immunosuppressive drug coverage for transplant 
              patients under part B.
Sec. 207. HHS study and report on uniform pharmacy benefit cards.
Sec. 208. GAO study and biennial reports on competition and savings.
Sec. 209. Expansion of membership and duties of Medicare Payment 
              Advisory Commission (MedPAC).

     SEC. 202. 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).
       ``(C) Clarification regarding immunosuppressive drugs.--In 
     the case of a beneficiary who is not eligible for any 
     coverage under part B of drugs described in section 
     1861(s)(2)(J) because of the requirements under such section 
     (and would not be so eligible if the individual were enrolled 
     under such part), the term `covered outpatient drug' shall 
     include such drugs if the drugs would otherwise be described 
     in subparagraph (A).
       ``(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);
       ``(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.--Beginning in 2005, 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 
     categories and classes of covered outpatient drugs.
       ``(b) Financing.--The costs of providing benefits under 
     this part shall be payable from the Prescription Drug 
     Account.


                       ``enrollment under program

       ``Sec. 1860B. (a) Establishment of Process.--
       ``(1) In general.--The Secretary shall establish a process 
     through which an eligible beneficiary (including an eligible 
     beneficiary enrolled in a Medicare+Choice plan offered

[[Page 15392]]

     by a Medicare+Choice organization) may make an election at 
     any time to enroll under the program under this part.
       ``(2) Enrollment and reenrollment at any time.--Under the 
     process established under paragraph (1), an eligible 
     beneficiary, beginning January 1, 2005, may--
       ``(A) make an election to enroll under the program under 
     this part at any time; and
       ``(B) terminate such election at any time and reenroll 
     under such program at any time.
       ``(3) Open enrollment period prior to january 1, 2005, for 
     individuals currently eligible.--The Secretary shall 
     establish an open enrollment period of not less than 5 months 
     to ensure that--
       ``(A) an individual who meets or will meet the definition 
     of an eligible beneficiary under section 1860(2) as of 
     January 1, 2005, is permitted to enroll under the program 
     under this part prior to such date; and
       ``(B) coverage under this part for such an individual is 
     effective as of such date.
       ``(4) Requirement of enrollment.--An eligible beneficiary 
     must be enrolled under this part in order to be eligible to 
     receive coverage of covered outpatient drugs under this 
     title.
       ``(5) Limitation.--Coverage under this part shall not begin 
     prior to January 1, 2005.
       ``(b) Termination.--
       ``(1) In general.--The causes of termination specified in 
     section 1838 shall apply to this part in a similar manner as 
     such causes apply to part B.
       ``(2) Coverage terminated by termination of coverage under 
     parts a and b.--
       ``(A) In general.--In addition to the causes of termination 
     specified in paragraph (1), the Secretary shall terminate an 
     individual's coverage under this part if the individual is no 
     longer enrolled in either part A or B.
       ``(B) Effective date.--The termination described in 
     subparagraph (A) shall be effective on the effective date of 
     termination of coverage under part A or (if later) under part 
     B.
       ``(3) Procedures regarding termination of a beneficiary 
     under a plan.--The Secretary shall establish procedures for 
     determining the status of an eligible beneficiary's 
     enrollment under this part if the beneficiary's enrollment in 
     a plan offered by an eligible entity under this part is 
     terminated by the entity for cause (pursuant to procedures 
     established by the Secretary under section 1860C(a)(1)).


                         ``enrollment in a plan

       ``Sec. 1860C. (a) Process.--
       ``(1) Establishment.--
       ``(A) Election.--
       ``(i) In general.--The Secretary shall establish a process 
     through which an eligible beneficiary who is enrolled under 
     this part but not enrolled in a Medicare+Choice plan offered 
     by a Medicare+Choice organization--

       ``(I) shall make an annual election to enroll in any plan 
     offered by an eligible entity that has been awarded a 
     contract under this part and serves the geographic area in 
     which the beneficiary resides; and
       ``(II) may make an annual election to change the election 
     under this clause.

       ``(ii) Default enrollment.--Such process shall include for 
     the default enrollment in such a plan in the case of an 
     eligible beneficiary who is enrolled under this part but who 
     has failed to make an election of such a plan.
       ``(B) Rules.--In establishing the process under 
     subparagraph (A), the Secretary shall--
       ``(i) use rules similar to the rules for enrollment, 
     disenrollment, and termination of enrollment with a 
     Medicare+Choice plan under section 1851, including--

       ``(I) the establishment of special election periods under 
     subsection (e)(4) of such section; and
       ``(II) the application of the guaranteed issue and renewal 
     provisions of subsection (g) of such section (other than 
     paragraph (3)(C)(i), relating to default enrollment); and

       ``(ii) coordinate enrollments, disenrollments, and 
     terminations of enrollment under part C with enrollments, 
     disenrollments, and terminations of enrollment under this 
     part.
       ``(2) First enrollment period for plan enrollment for 
     individuals currently eligible.--The process developed under 
     paragraph (1) shall--
       ``(A) ensure--
       ``(i) that an individual who meets or will meet the 
     definition of an eligible beneficiary under section 1860(2) 
     as of January 1, 2005, is permitted to enroll with an 
     eligible entity prior to January 1, 2005; and
       ``(ii) that coverage under this part for such an individual 
     is effective as of such date; and
       ``(B) be coordinated with the open enrollment described in 
     section 1860B(a)(3).
       ``(b) Medicare+Choice Enrollees.--
       ``(1) In general.--An eligible beneficiary who is enrolled 
     under this part and enrolled in a Medicare+Choice plan 
     offered by a Medicare+Choice organization shall receive 
     coverage of covered outpatient drugs under this part through 
     such plan.
       ``(2) Rules.--Enrollment in a Medicare+Choice plan is 
     subject to the rules for enrollment in such a plan under 
     section 1851.


                ``providing information to beneficiaries

       ``Sec. 1860D. (a) Activities.--
       ``(1) In general.--The Secretary shall conduct activities 
     that are designed to broadly disseminate information to 
     eligible beneficiaries (and prospective eligible 
     beneficiaries) regarding the coverage provided under this 
     part.
       ``(2) Special rule for first enrollment under the 
     program.--To the extent practicable, the activities described 
     in paragraph (1) shall ensure that individuals who meet or 
     will meet the definition of an eligible beneficiary under 
     section 1860(2) as of January 1, 2005, and other prospective 
     eligible beneficiaries, are provided with such information at 
     least 30 days prior to the open enrollment period described 
     in section 1860B(a)(3).
       ``(b) Requirements.--
       ``(1) In general.--The activities described in subsection 
     (a) shall--
       ``(A) be similar to the activities performed by the 
     Secretary under section 1851(d);
       ``(B) be coordinated with the activities performed by the 
     Secretary under such section and under section 1804; and
       ``(C) provide for the dissemination of information 
     comparing the plans offered by eligible entities under this 
     part that are available to eligible beneficiaries residing in 
     an area.
       ``(2) Comparative information.--The comparative information 
     described in paragraph (1)(C) shall include a comparison of 
     the following:
       ``(A) Benefits.--The benefits provided under the plan, 
     including the negotiated prices beneficiaries will be charged 
     for covered outpatient drugs, any preferred pharmacy networks 
     used by the eligible entity under the plan, and the 
     formularies and appeals processes under the plan.
       ``(B) Quality and performance.--To the extent available, 
     the quality and performance of the eligible entity offering 
     the plan.
       ``(C) Beneficiary cost-sharing.--The cost-sharing required 
     of eligible beneficiaries under the plan.
       ``(D) Consumer satisfaction surveys.--To the extent 
     available, the results of consumer satisfaction surveys 
     regarding the plan and the eligible entity offering such 
     plan.
       ``(E) Additional information.--Such additional information 
     as the Secretary may prescribe.
       ``(3) Information standards.--The Secretary shall develop 
     standards to ensure that the information provided to eligible 
     beneficiaries under this part is complete, accurate, and 
     uniform.
       ``(c) Use of Medicare Consumer Coalitions To Provide 
     Information.--
       ``(1) In general.--The Secretary may contract with Medicare 
     Consumer Coalitions to conduct the informational activities 
     under--
       ``(A) this section;
       ``(B) section 1851(d); and
       ``(C) section 1804.
       ``(2) Selection of coalitions.--If the Secretary determines 
     the use of Medicare Consumer Coalitions to be appropriate, 
     the Secretary shall--
       ``(A) develop and disseminate, in such areas as the 
     Secretary determines appropriate, a request for proposals for 
     Medicare Consumer Coalitions to contract with the Secretary 
     in order to conduct any of the informational activities 
     described in paragraph (1); and
       ``(B) select a proposal of a Medicare Consumer Coalition to 
     conduct the informational activities in each such area, with 
     a preference for broad participation by organizations with 
     experience in providing information to beneficiaries under 
     this title.
       ``(3) Payment to medicare consumer coalitions.--The 
     Secretary shall make payments to Medicare Consumer Coalitions 
     contracting under this subsection in such amounts and in such 
     manner as the Secretary determines appropriate.
       ``(4) Authorization of appropriations.--There are 
     authorized to be appropriated to the Secretary, out of any 
     moneys in the Treasury not otherwise appropriated, such sums 
     as may be necessary to contract with Medicare Consumer 
     Coalitions under this section.
       ``(5) Medicare consumer coalition defined.--In this 
     subsection, the term `Medicare Consumer Coalition' means an 
     entity that is a nonprofit organization operated under the 
     direction of a board of directors that is primarily composed 
     of beneficiaries under this title.


                      ``no premium for enrollment

       ``Sec. 1860E. (a) No Premium for Enrollment.--An eligible 
     beneficiary enrolled under the program under this part shall 
     not be responsible for the payment of a premium for such 
     enrollment.
       ``(b) Annual Enrollment Fee.--
       ``(1) In general.--Subject to paragraph (2), enrollment 
     under the program under this part is conditioned upon payment 
     of an annual enrollment fee of $25.
       ``(2) Inflation adjustment.--
       ``(A) In general.--For any year after 2005, the annual 
     enrollment fee specified in paragraph (1) is equal to the 
     annual enrollment fee determined under such paragraph (or 
     this paragraph) for the previous year increased by the annual 
     percentage increase described in subparagraph (B).

[[Page 15393]]

       ``(B) Annual percentage increase specified.--The annual 
     percentage increase specified in this subparagraph for a year 
     is equal to the annual percentage increase in average per 
     capita aggregate expenditures for covered outpatient drugs in 
     the United States for medicare beneficiaries, as determined 
     by the Secretary for the 12-month period ending in July of 
     the previous year.
       ``(C) Rounding.--If any amount determined under 
     subparagraph (A) is not a multiple of $1, such amount shall 
     be rounded to the nearest multiple of $1.
       ``(3) Collection.--
       ``(A) In general.--Unless the eligible beneficiary makes an 
     election under subparagraph (B), the annual enrollment fee 
     described in paragraph (1) shall be collected and credited to 
     the Prescription Drug Account in a similar manner as the 
     monthly premium determined under section 1839 is collected 
     and credited to the Federal Supplementary Medical Insurance 
     Trust Fund under section 1840.
       ``(B) Direct payment.--An eligible beneficiary may elect to 
     pay the annual enrollment fee directly to the Secretary or in 
     any other manner approved by the Secretary. The Secretary 
     shall establish procedures for making such an election.


                ``outpatient prescription drug benefits

       ``Sec. 1860F. (a) Requirement.--A plan offered by an 
     eligible entity under this part shall provide eligible 
     beneficiaries enrolled in such plan with--
       ``(1) coverage of covered outpatient drugs--
       ``(A) without the application of any deductible; and
       ``(B) with the cost-sharing described in subsection (b); 
     and
       ``(2) access to negotiated prices for such drugs under 
     subsection (c).
       ``(b) Cost-Sharing.--
       ``(1) Coinsurance for formulary drugs before catastrophic 
     limit reached.--Subject to paragraphs (2), (3), and (4), in 
     the case of a covered outpatient drug that is included in the 
     formulary established by the eligible entity (pursuant to 
     section 1860H(c)) for the plan and that is dispensed to an 
     eligible beneficiary, the beneficiary shall be responsible 
     for coinsurance for the drug in an amount equal to the 
     negotiated price for the drug (as reported to the Secretary 
     pursuant to section 1860H(a)(6)(A)) minus 5 percent of such 
     negotiated price.
       ``(2) Beneficiary responsible for negotiated price for 
     nonformulary drugs before catastrophic limit reached.--
       ``(A) In general.--In the case of a covered outpatient drug 
     that is not included in the formulary for the plan (and not 
     treated as a brand name drug on the formulary under paragraph 
     (B)) and that is dispensed to an eligible beneficiary in a 
     year before the beneficiary has reached the catastrophic 
     limit under paragraph (3) for the year, the beneficiary shall 
     be responsible for the negotiated price for the drug (as 
     reported to the Secretary pursuant to section 
     1860H(a)(6)(A)).
       ``(B) Treatment of medically necessary nonformulary 
     drugs.--The eligible entity shall treat a drug not included 
     in the formulary for the plan as a brand name drug on the 
     formulary if such nonformulary drug is determined (pursuant 
     to subparagraph (D) or (E) of section 1860H(a)(4)) to be 
     medically necessary, and the beneficiary shall be responsible 
     for the coinsurance described in paragraph (1).
       ``(3) Copayment once expenses equal annual catastrophic 
     limit.--
       ``(A) In general.--Subject to paragraphs (4) and (5), in 
     the case of a covered outpatient drug (regardless of whether 
     it is included in the formulary or not so included) that is 
     dispensed in a year to an eligible beneficiary after the 
     beneficiary has incurred costs (as described in subparagraph 
     (C)) for such drugs in a year equal to the annual 
     catastrophic limit specified in subparagraph (B), the 
     beneficiary shall be responsible for a copayment for the drug 
     in an amount equal to $10 for each prescription (as defined 
     in subparagraph (D)) of such drug.
       ``(B) Annual catastrophic limit.--Subject to paragraph (5), 
     for purposes of this part, the `annual catastrophic limit' 
     specified in this subparagraph is equal to $3,300.
       ``(C) Application.--In applying subparagraph (A)--
       ``(i) incurred costs shall only include costs incurred for 
     the cost-sharing described in this subsection (including the 
     cost-sharing described in paragraph (2)(A)); but
       ``(ii) such costs shall be treated as incurred only if they 
     are paid by the individual (or by another individual, such as 
     a family member, on behalf of the individual), under title 
     XIX, or by a State pharmacy assistance program, and the 
     individual (or other individual) is not reimbursed through 
     insurance or otherwise, a group health plan, or other third-
     party payment arrangement for such costs.
       ``(D) Prescription defined.--
       ``(i) In general.--Subject to clause (ii), for purposes of 
     subparagraph (A), the term `prescription' means--

       ``(I) a 30-day supply for a maintenance drug; and
       ``(II) a supply necessary for the length of the course that 
     is typical of current practice for a nonmaintenance drug.

       ``(ii) Special Rule for mail order drugs.--In the case of 
     drugs obtained by mail order, the term `prescription' may be 
     for a supply that is longer than the period specified in 
     subclause (I) or (II) of clause (i) (as the case may be) if 
     the Secretary determines that the longer supply will not 
     result in an increase in the expenditures made from the 
     Prescription Drug Account.
       ``(E) Copayment may not exceed negotiated price.--If the 
     amount of the copayment for a covered outpatient drug that 
     would otherwise be required under this paragraph (but for 
     this subparagraph) is greater than the negotiated price for 
     the drug (as reported to the Secretary pursuant to section 
     1860H(a)(6)(A)), then the amount of such copayment shall be 
     reduced to an amount equal to such negotiated price.
       ``(4) Reduction by eligible entity.--An eligible entity 
     offering a plan under this part may reduce the coinsurance 
     amount that an eligible beneficiary enrolled in the plan is 
     subject to under paragraph (1) or the copayment amount that 
     such a beneficiary is subject to under paragraph (3) if the 
     Secretary determines that such reduction--
       ``(A) is tied to the performance requirements described in 
     section 1860I(b)(1)(C); and
       ``(B) will not result in an increase in the expenditures 
     made from the Prescription Drug Account.
       ``(5) Inflation adjustment for copayment and annual 
     catastrophic limit.--
       ``(A) In general.--For any year after 2005--
       ``(i) the copayment amount described in paragraph (3)(A) is 
     equal to the copayment amount determined under such paragraph 
     (or this paragraph) for the previous year, increased by the 
     annual percentage increase described in section 
     1860E(b)(2)(B); and
       ``(ii) the annual catastrophic limit specified in paragraph 
     (3)(B) is equal to the annual catastrophic limit determined 
     under such paragraph (or this paragraph) for the previous 
     year increased by the annual percentage increase described in 
     section 1860E(b)(2)(B).
       ``(B) Rounding.--If any amount determined under clause (i) 
     or (ii) of subparagraph (A) is not a multiple of $1, such 
     amount shall be rounded to the nearest multiple of $1.
       ``(c) Access to Negotiated Prices.--
       ``(1) Access.--Under a plan offered by an eligible entity 
     with a contract under this part, the eligible entity offering 
     such plan shall provide eligible beneficiaries enrolled in 
     such plan with access to negotiated prices (including 
     applicable discounts) used for payment for covered outpatient 
     drugs, regardless of the fact that only partial benefits or 
     no benefits (because of the application of subsection 
     (b)(2)(A)) may be payable under the coverage with respect to 
     such drugs because of the application of the cost-sharing 
     under subsection (b).
       ``(2) Medicaid related provisions.--Insofar as a State 
     elects to provide medical assistance under title XIX for a 
     drug based on the prices negotiated under a plan under this 
     part, the requirements of section 1927 shall not apply to 
     such drugs. The prices negotiated under a plan under this 
     part with respect to covered outpatient drugs, under a 
     Medicare+Choice plan with respect to such drugs, or under a 
     qualified retiree prescription drug plan (as defined in 
     section 1860J(e)(3)) with respect to such drugs, on behalf of 
     eligible beneficiaries, shall (notwithstanding any other 
     provision of law) not be taken into account for the purposes 
     of establishing the best price under section 1927(c)(1)(C).


         ``entities eligible to provide outpatient drug benefit

       ``Sec. 1860G. (a) Establishment of Panels of Plans 
     Available in an Area.--
       ``(1) In general.--The Secretary shall establish procedures 
     under which the Secretary--
       ``(A) accepts bids submitted by eligible entities for the 
     plans which such entities intend to offer in an area 
     established under subsection (b); and
       ``(B) awards contracts to such entities to provide such 
     plans to eligible beneficiaries in the area.
       ``(2) Competitive procedures.--Competitive procedures (as 
     defined in section 4(5) of the Office of Federal Procurement 
     Policy Act (41 U.S.C. 403(5))) shall be used to enter into 
     contracts under this part.
       ``(b) Area for Contracts.--
       ``(1) Regional basis.--
       ``(A) In general.--Except as provided in subparagraph (B) 
     and subject to paragraph (2), the contract entered into 
     between the Secretary and an eligible entity with respect to 
     a plan shall require the eligible entity to provide coverage 
     of covered outpatient drugs under the plan in a region 
     established by the Secretary under paragraph (2).
       ``(B) Partial regional basis.--
       ``(i) In general.--If determined appropriate by the 
     Secretary, the Secretary may permit the coverage described in 
     subparagraph (A) to be provided in a partial region 
     determined appropriate by the Secretary.
       ``(ii) Requirements.--If the Secretary permits coverage 
     pursuant to clause (i), the Secretary shall ensure that the 
     partial region in which coverage is provided is--

       ``(I) at least the size of the commercial service area of 
     the eligible entity for that area; and
       ``(II) not smaller than a State.

       ``(2) Establishment of regions.--

[[Page 15394]]

       ``(A) In general.--In establishing regions for contracts 
     under this part, the Secretary shall--
       ``(i) take into account the number of eligible 
     beneficiaries in an area in order to encourage participation 
     by eligible entities;
       ``(ii) ensure that there are at least 10 different regions 
     in the United States; and
       ``(iii) ensure that a region (or partial region under 
     paragraph (1)(B)) would not discriminate based on the health 
     or economic status of potential enrollees.
       ``(B) No administrative or judicial review.--The 
     establishment of regions and partial regions under this 
     section shall not be subject to administrative or judicial 
     review.
       ``(c) Submission of Bids.--
       ``(1) Submission.--
       ``(A) In general.--Subject to subparagraph (B), each 
     eligible entity desiring to offer a plan under this part in 
     an area shall submit a bid with respect to such plan to the 
     Secretary at such time, in such manner, and accompanied by 
     such information as the Secretary may reasonably require.
       ``(B) Bid that covers multiple areas.--The Secretary shall 
     permit an eligible entity to submit a single bid for multiple 
     areas if the bid is applicable to all such areas.
       ``(2) Required information.--The bid described in paragraph 
     (1) shall include--
       ``(A) a proposal for the estimated negotiated prices of 
     covered outpatient drugs and the projected annual increases 
     in such prices, including differentials between formulary and 
     nonformulary prices, if applicable;
       ``(B) a statement regarding the amount that the entity will 
     charge the Secretary for managing, administering, and 
     delivering the benefits under the contract;
       ``(C) a statement regarding whether the entity will reduce 
     the applicable coinsurance or copayment amounts pursuant to 
     section 1860F(b)(4)) and if so, the amount of such reduction 
     and how such reduction is tied to the performance 
     requirements described in section 1860I(b)(1)(C);
       ``(D) a detailed description of the performance 
     requirements for which the payments to the entity will be 
     subject to risk pursuant to section 1860I(b)(1)(C);
       ``(E) a detailed description of access to pharmacy services 
     provided under the plan;
       ``(F) with respect to the formulary used by the entity, a 
     detailed description of the procedures and standards the 
     entity will use for--
       ``(i) adding new drugs to a therapeutic category or class 
     within the formulary; and
       ``(ii) determining when and how often the formulary should 
     be modified;
       ``(G) a detailed description of any ownership or shared 
     financial interests with other entities involved in the 
     delivery of the benefit as proposed under the plan;
       ``(H) a detailed description of the entity's estimated 
     marketing and advertising expenditures related to enrolling 
     eligible beneficiaries under the plan and retaining such 
     enrollment; and
       ``(I) such other information that the Secretary determines 
     is necessary in order to carry out this part, including 
     information relating to the bidding process under this part.
       ``(d) Access to Benefits in Certain Areas.--
       ``(1) Areas not covered by contracts.--The Secretary shall 
     develop procedures for the provision of covered outpatient 
     drugs under this part to each eligible beneficiary enrolled 
     under this part that resides in an area that is not covered 
     by any contract under this part.
       ``(2) Beneficiaries residing in different locations.--The 
     Secretary shall develop procedures to ensure that each 
     eligible beneficiary enrolled under this part that resides in 
     different areas in a year is provided the benefits under this 
     part throughout the entire year.
       ``(e) Awarding of Contracts.--
       ``(1) Number of contracts.--The Secretary shall, consistent 
     with the requirements of this part and the goal of containing 
     costs under this title, award in a competitive manner at 
     least 2 contracts to offer a plan in an area, unless only 1 
     bidding entity (and the plan offered by the entity) meets the 
     minimum standards specified under this part and by the 
     Secretary.
       ``(2) Determination.--In determining which of the eligible 
     entities that submitted bids that meet the minimum standards 
     specified under this part and by the Secretary to award a 
     contract, the Secretary shall consider the comparative merits 
     of each bid, as determined on the basis of the past 
     performance of the entity and other relevant factors, with 
     respect to--
       ``(A) how well the entity (and the plan offered by the 
     entity) meet such minimum standards;
       ``(B) the amount that the entity will charge the Secretary 
     for managing, administering, and delivering the benefits 
     under the contract;
       ``(C) the performance requirements for which the payments 
     to the entity will be subject to risk pursuant to section 
     1860I(b)(1)(C);
       ``(D) the proposed negotiated prices of covered outpatient 
     drugs and annual increases in such prices;
       ``(E) the factors described in section 1860D(b)(2);
       ``(F) prior experience of the entity in managing, 
     administering, and delivering a prescription drug benefit 
     program;
       ``(G) effectiveness of the entity and plan in containing 
     costs through pricing incentives and utilization management; 
     and
       ``(H) such other factors as the Secretary deems necessary 
     to evaluate the merits of each bid.
       ``(3) Exception to conflict of interest rules.--In awarding 
     contracts under this part, the Secretary may waive conflict 
     of interest laws generally applicable to Federal acquisitions 
     (subject to such safeguards as the Secretary may find 
     necessary to impose) in circumstances where the Secretary 
     finds that such waiver--
       ``(A) is not inconsistent with the--
       ``(i) purposes of the programs under this title; or
       ``(ii) best interests of beneficiaries enrolled under this 
     part; and
       ``(B) permits a sufficient level of competition for such 
     contracts, promotes efficiency of benefits administration, or 
     otherwise serves the objectives of the program under this 
     part.
       ``(4) No administrative or judicial review.--The 
     determination of the Secretary to award or not award a 
     contract to an eligible entity with respect to a plan under 
     this part shall not be subject to administrative or judicial 
     review.
       ``(f) Approval of Marketing Material and Application 
     Forms.--The provisions of section 1851(h) shall apply to 
     marketing material and application forms under this part in 
     the same manner as such provisions apply to marketing 
     material and application forms under part C.
       ``(g) Duration of Contracts.--Each contract awarded under 
     this part shall be for a term of at least 2 years but not 
     more than 5 years, as determined by the Secretary.
       ``(h) Financial Incentives for Pharmacies To Participate in 
     Certain Programs and Systems.--The Secretary may establish 
     and provide for incentives for pharmacies to participate in 
     the following:
       ``(1) Cost and drug utilization management programs.--
     Effective cost and drug utilization management programs, 
     including such programs that promote appropriate use of 
     generic drugs in order to maximize savings to the program 
     under this part.
       ``(2) Quality assurance measures and systems.--Quality 
     assurance measures and systems to reduce medical errors.
       ``(3) Programs to control fraud, abuse, and waste.--
     Programs to control fraud, abuse, and waste.


               ``minimum standards for eligible entities

       ``Sec. 1860H. (a) In General.--The Secretary shall not 
     award a contract to an eligible entity under this part unless 
     the Secretary finds that the eligible entity agrees to comply 
     with such terms and conditions as the Secretary shall 
     specify, including the following:
       ``(1) Quality and financial standards.--The eligible entity 
     meets the quality and financial standards specified by the 
     Secretary.
       ``(2) Procedures to ensure proper utilization, compliance, 
     and avoidance of adverse drug reactions.--
       ``(A) In general.--The eligible entity has in place drug 
     utilization review procedures to ensure--
       ``(i) the appropriate utilization by eligible beneficiaries 
     enrolled in the plan covered by the contract of the benefits 
     to be provided under the plan;
       ``(ii) the avoidance of adverse drug reactions among such 
     beneficiaries, including problems due to therapeutic 
     duplication, drug-disease contraindications, drug-drug 
     interactions (including serious interactions with 
     nonprescription or over-the-counter drugs), incorrect drug 
     dosage or duration of drug treatment, drug-allergy 
     interactions, and clinical abuse and misuse; and
       ``(iii) the reasonable application of peer-reviewed medical 
     literature pertaining to improvements in pharmaceutical 
     safety and appropriate use of drugs.
       ``(B) Authority to use certain compendia and literature.--
     The eligible entity may use the compendia and literature 
     referred to in clauses (i) and (ii), respectively, of section 
     1927(g)(1)(B) as a source for the utilization review under 
     subparagraph (A).
       ``(3) Electronic prescription program.--
       ``(A) In general.--The eligible entity has in place, for 
     years beginning with 2006, an electronic prescription drug 
     program that includes at least the following components, 
     consistent with national standards established under 
     subparagraph (B):
       ``(i) Electronic transmittal of prescriptions.--
     Prescriptions are only received electronically, except in 
     emergency cases and other exceptional circumstances 
     recognized by the Secretary.
       ``(ii) Provision of information to prescribing health care 
     professional.--The program provides, upon transmittal of a 
     prescription by a prescribing health care professional, for 
     transmittal by the pharmacist to the professional of 
     information that includes--

       ``(I) information (to the extent available and feasible) on 
     the drugs being prescribed for that patient and other 
     information relating to the medical history or condition of 
     the patient that may be relevant to the appropriate 
     prescription for that patient;

[[Page 15395]]

       ``(II) cost-effective alternatives (if any) for the use of 
     the drug prescribed; and
       ``(III) information on the drugs included in the applicable 
     formulary.

     To the extent feasible, such program shall permit the 
     prescribing health care professional to provide (and be 
     provided) related information on an interactive, real-time 
     basis.
       ``(B) Standards.--
       ``(i) Development.--The Secretary shall provide for the 
     development of national standards relating to the electronic 
     prescription drug program described in subparagraph (A). Such 
     standards shall be compatible with standards established 
     under part C of title XI.
       ``(ii) Advisory task force.--In developing such standards, 
     the Secretary shall establish a task force that includes 
     representatives of physicians, hospitals, pharmacists, and 
     technology experts and representatives of the Departments of 
     Veterans Affairs and Defense and other appropriate Federal 
     agencies to provide recommendations to the Secretary on such 
     standards, including recommendations relating to the 
     following:

       ``(I) The range of available computerized prescribing 
     software and hardware and their costs to develop and 
     implement.
       ``(II) The extent to which such systems reduce medication 
     errors and can be readily implemented by physicians and 
     hospitals.
       ``(III) Efforts to develop a common software platform for 
     computerized prescribing.
       ``(IV) The cost of implementing such systems in the range 
     of hospital and physician office settings, including 
     hardware, software, and training costs.
       ``(V) Implementation issues as they relate to part C of 
     title XI, and current Federal and State prescribing laws and 
     regulations and their impact on implementation of 
     computerized prescribing.

       ``(iii) Deadlines.--

       ``(I) The Secretary shall constitute the task force under 
     clause (ii) by not later than April 1, 2003.
       ``(II) The task force shall submit recommendations to the 
     Secretary by not later than January 1, 2004.
       ``(III) The Secretary shall develop and promulgate the 
     national standards referred to in clause (ii) by not later 
     than January 1, 2005.

       ``(C) Waiver of application for certain rural providers.--
     If the Secretary determines that it is unduly burdensome on 
     providers in rural areas to comply with the requirements 
     under this paragraph, the Secretary may waive such 
     requirements for such providers.
       ``(4) Patient protections.--
       ``(A) Access.--
       ``(i) In general.--The eligible entity ensures that the 
     covered outpatient drugs are accessible and convenient to 
     eligible beneficiaries enrolled in the plan covered by the 
     contract, including by offering the services 24 hours a day 
     and 7 days a week for emergencies.
       ``(ii) Negotiated participation agreements with 
     pharmacies.--The eligible entity shall negotiate and enter 
     into a participation agreement with any pharmacy that meets 
     the requirements of subsection (d) to dispense covered 
     prescription drugs to eligible beneficiaries under this part. 
     Such agreements shall include the payment of a reasonable 
     dispensing fee for covered outpatient drugs dispensed to a 
     beneficiary under the agreement.
       ``(iii) Preferred pharmacy networks.--If the eligible 
     entity utilizes a preferred pharmacy network, the network 
     complies with the standards under subsection (e).
       ``(B) Ensuring that beneficiaries are not overcharged.--The 
     eligible entity has procedures in place to ensure that each 
     pharmacy with a negotiated participation agreement under this 
     part with the entity complies with the requirements under 
     subsection (d)(1)(C) (relating to adherence to negotiated 
     prices).
       ``(C) Continuity of care.--
       ``(i) In general.--The eligible entity ensures that, in the 
     case of an eligible beneficiary who loses coverage under this 
     part with such entity under circumstances that would permit a 
     special election period (as established by the Secretary 
     under section 1860C(a)(1)), the entity will continue to 
     provide coverage under this part to such beneficiary until 
     the beneficiary enrolls and receives such coverage with 
     another eligible entity under this part or, if eligible, with 
     a Medicare+Choice organization.
       ``(ii) Limited period.--In no event shall an eligible 
     entity be required to provide the extended coverage required 
     under clause (i) beyond the date which is 30 days after the 
     coverage with such entity would have terminated but for this 
     subparagraph.
       ``(D) Procedures regarding the determination of drugs that 
     are medically necessary.--
       ``(i) In general.--The eligible entity has in place 
     procedures on a case-by-case basis to treat a drug not 
     included in the formulary for the plan as a brand name drug 
     on the formulary under this part if the formulary drug for 
     treatment of the same condition is determined--

       ``(I) to be not as effective for the enrollee as the 
     nonformulary drug in preventing or slowing the deterioration 
     of, or improving or maintaining, the health of the enrollee; 
     or
       ``(II) to have a significant adverse effect on the 
     enrollee.

       ``(ii) Requirement.--The procedures under clause (i) shall 
     require that determinations under such clause are based on 
     professional medical judgment, the medical condition of the 
     enrollee, and other medical evidence.
       ``(E) Procedures regarding appeal rights with respect to 
     denials of care.--The eligible entity has in place procedures 
     to ensure--
       ``(i) a timely internal review for resolution of denials of 
     coverage (in whole or in part and including those regarding 
     the coverage of drugs not included on the formulary of the 
     plan as brand name drugs on the formulary) in accordance with 
     the medical exigencies of the case and a timely resolution of 
     complaints, by enrollees in the plan, or by providers, 
     pharmacists, and other individuals acting on behalf of each 
     such enrollee (with the enrollee's consent) in accordance 
     with requirements (as established by the Secretary) that are 
     comparable to such requirements for Medicare+Choice 
     organizations under part C (and are not less favorable to the 
     enrollee than such requirements under such part as in effect 
     on the date of enactment of the Medicare Prescription Drug 
     Cost Protection Act of 2002);
       ``(ii) that the entity complies in a timely manner with 
     requirements established by the Secretary that (I) provide 
     for an external review by an independent entity selected by 
     the Secretary of denials of coverage described in clause (i) 
     not resolved in the favor of the beneficiary (or other 
     complainant) under the process described in such clause, and 
     (II) are comparable to the external review requirements 
     established for Medicare+Choice organizations under part C 
     (and are not less favorable to the enrollee than such 
     requirements under such part as in effect on the date of 
     enactment of the Medicare Prescription Drug Cost Protection 
     Act of 2002); and
       ``(iii) that enrollees are provided with information 
     regarding the appeals procedures under this part at the time 
     of enrollment with the entity and upon request thereafter.
       ``(F) Procedures regarding patient confidentiality.--
     Insofar as an eligible entity maintains individually 
     identifiable medical records or other health information 
     regarding eligible beneficiaries enrolled in the plan that is 
     covered by the contract, the entity has in place procedures 
     to--
       ``(i) safeguard the privacy of any individually 
     identifiable beneficiary information in a manner consistent 
     with the Federal regulations (concerning the privacy of 
     individually identifiable health information) promulgated 
     under section 264(c) of the Health Insurance Portability and 
     Accountability Act of 1996 (Public Law 104-191; 110 Stat. 
     2033);
       ``(ii) maintain such records and information in a manner 
     that is accurate and timely;
       ``(iii) ensure timely access by such beneficiaries to such 
     records and information; and
       ``(iv) otherwise comply with applicable laws relating to 
     patient confidentiality.
       ``(G) Procedures regarding transfer of medical records.--
       ``(i) In general.--The eligible entity has in place 
     procedures for the timely transfer of records and information 
     described in subparagraph (F) (with respect to a beneficiary 
     who loses coverage under this part with the entity and 
     enrolls with another entity (including a Medicare+Choice 
     organization) under this part) to such other entity.
       ``(ii) Patient confidentiality.--The procedures described 
     in clause (i) shall comply with the patient confidentiality 
     procedures described in subparagraph (F).
       ``(H) Procedures regarding medical errors.--The eligible 
     entity has in place procedures for--
       ``(i) working with the Secretary to deter medical errors 
     related to the provision of covered outpatient drugs; and
       ``(ii) ensuring that pharmacies with a contract with the 
     entity have in place procedures to deter medical errors 
     related to the provision of covered outpatient drugs.
       ``(5) Procedures to control fraud, abuse, and waste.--
       ``(A) In general.--The eligible entity has in place 
     procedures to control fraud, abuse, and waste.
       ``(B) Applicability of fraud and abuse provisions.--The 
     provisions of section 1128 through 1128C (relating to fraud 
     and abuse) apply to eligible entities with contracts under 
     this part.
       ``(6) Reporting requirements.--
       ``(A) In general.--The eligible entity provides the 
     Secretary with reports containing information regarding the 
     following:
       ``(i) The negotiated prices that the eligible entity is 
     paying for covered outpatient drugs.
       ``(ii) The negotiated prices that eligible beneficiaries 
     enrolled in the plan that is covered by the contract will be 
     charged for covered outpatient drugs.
       ``(iii) The management costs of providing such benefits.
       ``(iv) Utilization of such benefits.
       ``(v) Marketing and advertising expenditures related to 
     enrolling and retaining eligible beneficiaries.
       ``(B) Timeframe for submitting reports.--

[[Page 15396]]

       ``(i) In general.--The eligible entity shall submit a 
     report described in subparagraph (A) to the Secretary within 
     3 months after the end of each 12-month period in which the 
     eligible entity has a contract under this part. Such report 
     shall contain information concerning the benefits provided 
     during such 12-month period.
       ``(ii) Last year of contract.--In the case of the last year 
     of a contract under this part, the Secretary may require that 
     a report described in subparagraph (A) be submitted 3 months 
     prior to the end of the contract. Such report shall contain 
     information concerning the benefits provided between the 
     period covered by the most recent report under this 
     subparagraph and the date that a report is submitted under 
     this clause.
       ``(C) Confidentiality of information.--
       ``(i) In general.--Notwithstanding any other provision of 
     law and subject to clause (ii), information disclosed by an 
     eligible entity pursuant to subparagraph (A) (except for 
     information described in clause (ii) of such subparagraph) is 
     confidential and shall only be used by the Secretary for the 
     purposes of, and to the extent necessary, to carry out this 
     part.
       ``(ii) Utilization data.--Subject to patient 
     confidentiality laws, the Secretary shall make information 
     disclosed by an eligible entity pursuant to subparagraph 
     (A)(iv) (regarding utilization data) available for research 
     purposes. The Secretary may charge a reasonable fee for 
     making such information available.
       ``(7) Approval of marketing material and application 
     forms.--The eligible entity complies with the requirements 
     described in section 1860G(f).
       ``(8) Records and audits.--The eligible entity maintains 
     adequate records related to the management, administration, 
     and delivery of the benefits under this part and affords the 
     Secretary access to such records for auditing purposes.
       ``(b) Special Rules Regarding Cost-Effective Provision of 
     Benefits.--
       ``(1) In general.--In providing the benefits under a 
     contract under this part, an eligible entity shall--
       ``(A) employ mechanisms to provide the benefits 
     economically, such as through the use of--
       ``(i) alternative methods of distribution;
       ``(ii) preferred pharmacy networks (pursuant to subsection 
     (e)); and
       ``(iii) generic drug substitution;
       ``(B) use mechanisms to encourage eligible beneficiaries to 
     select cost-effective drugs or less costly means of receiving 
     drugs, such as through the use of--
       ``(i) pharmacy incentive programs;
       ``(ii) therapeutic interchange programs; and
       ``(iii) disease management programs;
       ``(C) encourage pharmacists to--
       ``(i) inform beneficiaries of the differentials in price 
     between generic and brand name drug equivalents; and
       ``(ii) provide medication therapy management programs in 
     order to enhance beneficiaries' understanding of the 
     appropriate use of medications and to reduce the risk of 
     potential adverse events associated with medications; and
       ``(D) develop and implement a formulary in accordance with 
     subsection (c).
       ``(2) Restriction.--If an eligible entity uses alternative 
     methods of distribution pursuant to paragraph (1)(A)(i), the 
     entity may not require that a beneficiary use such methods in 
     order to obtain covered outpatient drugs.
       ``(c) Requirements for Formularies.--
       ``(1) Standards.--
       ``(A) In general.--The formulary developed and implemented 
     by the eligible entity shall comply with standards 
     established by the Secretary in consultation with the 
     Medicare Prescription Drug Advisory Committee established 
     under section 1860L.
       ``(B) No national formulary or requirement to exclude 
     specific drugs.--
       ``(i) Secretary may not establish a national formulary.--
     The Secretary may not establish a national formulary.
       ``(ii) No requirement to exclude specific drugs.--The 
     standards established by the Secretary pursuant to 
     subparagraph (A) may not require that an eligible entity 
     exclude a specific covered outpatient drug from the formulary 
     developed and implemented by the entity.
       ``(2) Requirements for standards.--The standards 
     established under paragraph (1)(A) shall require that the 
     eligible entity--
       ``(A) use a pharmacy and therapeutic committee (that meets 
     the standards for a pharmacy and therapeutic committee 
     established by the Secretary in consultation with such 
     Medicare Prescription Drug Advisory Committee) to develop and 
     implement the formulary;
       ``(B) include in the formulary--
       ``(i) all generic covered outpatient drugs; and
       ``(ii) covered outpatient drugs within each therapeutic 
     category and class (as defined by the Secretary in 
     consultation with such Medicare Prescription Drug Advisory 
     Committee) of such drugs, although not necessarily for all 
     drugs within such categories and classes;
       ``(C) develop procedures for the modification of the 
     formulary, including for the addition of new drugs to an 
     existing therapeutic category or class;
       ``(D) pursuant to section 1860F(b)(2)(B), provide for the 
     treatment of drugs not included in the formulary for the plan 
     as brand name drugs on the formulary when determined under 
     subparagraph (D) or (E) of subsection (a)(4) to be medically 
     necessary;
       ``(E) disclose to current and prospective beneficiaries and 
     to providers in the service area the nature of the formulary 
     restrictions, including information regarding the drugs 
     included in the formulary and any difference in the cost-
     sharing for drugs--
       ``(i) included in the formulary; and
       ``(ii) not included in the formulary; and
       ``(F) provide a reasonable amount of notice to 
     beneficiaries enrolled in the plan that is covered by the 
     contract under this part of any change in the formulary.
       ``(3) Construction.--Nothing in this part shall be 
     construed as precluding an eligible entity from--
       ``(A) educating prescribing providers, pharmacists, and 
     beneficiaries about the medical and cost benefits of drugs 
     included in the formulary for the plan (including generic 
     drugs); or
       ``(B) requesting prescribing providers to consider a drug 
     included in the formulary for the plan prior to dispensing of 
     a drug not so included, as long as such a request does not 
     unduly delay the provision of the drug.
       ``(d) Terms of Negotiated Participation Agreement With 
     Pharmacies.--
       ``(1) In general.--A negotiated participation agreement 
     between an eligible entity and a pharmacy under this part 
     (pursuant to subsection (a)(4)(A)(ii)) shall include the 
     following terms and conditions:
       ``(A) Applicable requirements.--The pharmacy shall meet 
     (and throughout the contract period continue to meet) all 
     applicable Federal requirements and State and local licensing 
     requirements.
       ``(B) Access and quality standards.--The pharmacy shall 
     comply with such standards as the Secretary (and the eligible 
     entity) shall establish concerning the quality of, and 
     enrolled beneficiaries' access to, pharmacy services under 
     this part. Such standards shall require the pharmacy--
       ``(i) not to refuse to dispense covered outpatient drugs to 
     any eligible beneficiary enrolled under this part;
       ``(ii) to keep patient records (including records on 
     expenses) for all covered outpatient drugs dispensed to such 
     enrolled beneficiaries;
       ``(iii) to submit information (in a manner specified by the 
     Secretary to be necessary to administer this part) on all 
     purchases of such drugs dispensed to such enrolled 
     beneficiaries; and
       ``(iv) to comply with periodic audits to assure compliance 
     with the requirements of this part and the accuracy of 
     information submitted.
       ``(C) Ensuring that beneficiaries are not overcharged.--
       ``(i) Adherence to negotiated prices.--The total charge for 
     each covered outpatient drug dispensed by the pharmacy to a 
     beneficiary enrolled in the plan, without regard to whether 
     the individual is financially responsible for any or all of 
     such charge, shall not exceed the negotiated price for the 
     drug (as reported to the Secretary pursuant to subsection 
     (a)(6)(A)).
       ``(ii) Adherence to beneficiary obligation.--The pharmacy 
     may not charge (or collect from) such beneficiary an amount 
     that exceeds the cost-sharing that the beneficiary is 
     responsible for under this part (as determined under section 
     1860F(b) using the negotiated price of the drug).
       ``(D) Additional requirements.--The pharmacy shall meet 
     such additional contract requirements as the eligible entity 
     specifies under this section.
       ``(2) Applicability of fraud and abuse provisions.--The 
     provisions of section 1128 through 1128C (relating to fraud 
     and abuse) apply to pharmacies participating in the program 
     under this part.
       ``(e) Preferred Pharmacy Networks.--
       ``(1) In general.--If an eligible entity uses a preferred 
     pharmacy network to deliver benefits under this part, such 
     network shall meet minimum access standards established by 
     the Secretary.
       ``(2) Standards.--In establishing standards under paragraph 
     (1), the Secretary shall take into account reasonable 
     distances to pharmacy services in both urban and rural areas.


                               ``payments

       ``Sec. 1860I. (a) Procedures for Payments to Eligible 
     Entities.--The Secretary shall establish procedures for 
     making payments to each eligible entity with a contract to 
     offer a plan under this part for the management, 
     administration, and delivery of the benefits under the plan.
       ``(b) Requirements for Procedures.--
       ``(1) In general.--The procedures established under 
     subsection (a) shall provide for the following:
       ``(A) Management payment.--Payment for the management, 
     administration, and delivery of the benefits under the plan.
       ``(B) Reimbursement for negotiated costs of drugs 
     provided.--Payments for the negotiated costs of covered 
     outpatient drugs provided to eligible beneficiaries enrolled 
     under this part and in the plan, reduced by

[[Page 15397]]

     any applicable cost-sharing under section 1860F(b).
       ``(C) Risk requirement to ensure pursuit of performance 
     requirements.--An adjustment of a percentage (as determined 
     under paragraph (3)) of the payments made to an entity under 
     subparagraph (A) to ensure that the entity, in managing, 
     administering, and delivering the benefits under the plan, 
     pursues performance requirements established by the 
     Secretary, including the following:
       ``(i) Control of medicare and beneficiary costs.--The 
     entity contains costs to the Prescription Drug Account and to 
     eligible beneficiaries enrolled under this part and in the 
     plan, as measured by generic substitution rates, price 
     discounts, and other factors determined appropriate by the 
     Secretary that do not reduce the access of such beneficiaries 
     to medically necessary covered outpatient drugs.
       ``(ii) Quality clinical care.--The entity provides such 
     beneficiaries with quality clinical care, as measured by such 
     factors as--

       ``(I) the level of adverse drug reactions and medical 
     errors among such beneficiaries; and
       ``(II) providing specific clinical suggestions to improve 
     health and patient and prescriber education as appropriate.

       ``(iii) Quality service.--The entity provides such 
     beneficiaries with quality services, as measured by such 
     factors as sustained pharmacy network access, timeliness and 
     accuracy of service delivery in claims processing and card 
     production, pharmacy and member service support access, 
     response time in mail delivery service, and timely action 
     with regard to appeals and current beneficiary service 
     surveys.
       ``(2) Secretary to consider risk profile of enrollees.--The 
     Secretary shall take into account the risk profile of 
     beneficiaries enrolled under this part and in the plan in 
     assessing the degree to which the entity is meeting the 
     performance requirements under paragraph (1)(C).
       ``(3) Percentage of payment tied to risk.--
       ``(A) In general.--Subject to subparagraph (B), the 
     Secretary shall determine the percentage (which may be up to 
     100 percent) of the payments made to an entity under 
     paragraph (1)(A) that will be tied to the performance 
     requirements described in paragraph (1)(C).
       ``(B) Limitation on risk to ensure program stability.--In 
     order to provide for program stability, the Secretary may not 
     establish a percentage to be adjusted under this subsection 
     at a level that jeopardizes the ability of an eligible entity 
     to administer and deliver the benefits under this part or 
     administer and deliver such benefits in a quality manner.
       ``(4) Pass-through of rebates, discounts, and price 
     concessions obtained by the eligible entity.--The Secretary 
     shall establish procedures for reducing the amount of 
     payments to an eligible entity under paragraph (1) to take 
     into account any rebates, discounts, or price concessions 
     obtained by the entity from manufacturers of covered 
     outpatient drugs, unless the Secretary determines that such 
     procedures are not in the best interests of the medicare 
     program or eligible beneficiaries.
       ``(c) Payments to Medicare+Choice Organizations.--For 
     provisions related to payments to Medicare+Choice 
     organizations for the management, administration, and 
     delivery of benefits under this part to eligible 
     beneficiaries enrolled in a Medicare+Choice plan offered by 
     the organization, see section 1853(c)(8).
       ``(d) Secondary Payer Provisions.--The provisions of 
     section 1862(b) shall apply to the benefits provided under 
     this part.


``employer incentive program for employment-based retiree drug coverage

       ``Sec. 1860J. (a) Program Authority.--The Secretary is 
     authorized to develop and implement a program under this 
     section to be known as the `Employer Incentive Program' that 
     encourages employers and other sponsors of employment-based 
     health care coverage to provide adequate prescription drug 
     benefits to retired individuals by subsidizing, in part, the 
     sponsor's cost of providing coverage under qualifying plans.
       ``(b) Sponsor Requirements.--In order to be eligible to 
     receive an incentive payment under this section with respect 
     to coverage of an individual under a qualified retiree 
     prescription drug plan (as defined in subsection (e)(3)), a 
     sponsor shall meet the following requirements:
       ``(1) Assurances.--The sponsor shall--
       ``(A) annually attest, and provide such assurances as the 
     Secretary may require, that the coverage offered by the 
     sponsor is a qualified retiree prescription drug plan, and 
     will remain such a plan for the duration of the sponsor's 
     participation in the program under this section; and
       ``(B) guarantee that it will give notice to the Secretary 
     and covered retirees--
       ``(i) at least 120 days before terminating its plan; and
       ``(ii) immediately upon determining that the actuarial 
     value of the prescription drug benefit under the plan falls 
     below the actuarial value of the outpatient prescription drug 
     benefit under this part.
       ``(2) Beneficiary information.--The sponsor shall report to 
     the Secretary, for each calendar quarter for which it seeks 
     an incentive payment under this section, the names and social 
     security numbers of all retirees (and their spouses and 
     dependents) covered under such plan during such quarter and 
     the dates (if less than the full quarter) during which each 
     such individual was covered.
       ``(3) Audits.--The sponsor and the employment-based retiree 
     health coverage plan seeking incentive payments under this 
     section shall agree to maintain, and to afford the Secretary 
     access to, such records as the Secretary may require for 
     purposes of audits and other oversight activities necessary 
     to ensure the adequacy of prescription drug coverage, the 
     accuracy of incentive payments made, and such other matters 
     as may be appropriate.
       ``(4) Other requirements.--The sponsor shall provide such 
     other information, and comply with such other requirements, 
     as the Secretary may find necessary to administer the program 
     under this section.
       ``(c) Incentive Payments.--
       ``(1) In general.--A sponsor that meets the requirements of 
     subsection (b) with respect to a quarter in a calendar year 
     shall be entitled to have payment made by the Secretary on a 
     quarterly basis (to the sponsor or, at the sponsor's 
     direction, to the appropriate employment-based health plan) 
     of an incentive payment, in the amount determined in 
     paragraph (2), for each retired individual (or spouse or 
     dependent) who--
       ``(A) was covered under the sponsor's qualified retiree 
     prescription drug plan during such quarter; and
       ``(B) was eligible for, but was not enrolled in, the 
     outpatient prescription drug benefit program under this part.
       ``(2) Amount of payment.--
       ``(A) In general.--The amount of the payment for a quarter 
     shall be, for each individual described in paragraph (1), \3/
     4\ of the sum of the monthly Government contribution amounts 
     (computed under subparagraph (B)) for each of the 3 months in 
     the quarter.
       ``(B) Computation of monthly government contribution 
     amount.--For purposes of subparagraph (A), the monthly 
     Government contribution amount for a month in a year is equal 
     to the amount by which--
       ``(i) \1/12\ of the amount estimated under subparagraph (C) 
     for the year involved; exceeds
       ``(ii) \1/12\ of the annual enrollment fee for the year 
     under section 1860E(b).
       ``(C) Estimate of average annual per capita aggregate 
     expenditures.--
       ``(i) In general.--The Secretary shall for each year after 
     2004 estimate for that year an amount equal to average annual 
     per capita aggregate expenditures payable from the 
     Prescription Drug Account for that year.
       ``(ii) Timeframe for estimation.--The Secretary shall make 
     the estimate described in clause (i) for a year before the 
     beginning of that year.
       ``(3) Payment date.--The payment under this section with 
     respect to a calendar quarter shall be payable as of the end 
     of the next succeeding calendar quarter.
       ``(d) Civil Money Penalties.--A sponsor, health plan, or 
     other entity that the Secretary determines has, directly or 
     through its agent, provided information in connection with a 
     request for an incentive payment under this section that the 
     entity knew or should have known to be false shall be subject 
     to a civil monetary penalty in an amount up to 3 times the 
     total incentive amounts under subsection (c) that were paid 
     (or would have been payable) on the basis of such 
     information.
       ``(e) Definitions.--In this section:
       ``(1) Employment-based retiree health coverage.--The term 
     `employment-based retiree health coverage' means health 
     insurance or other coverage, whether provided by voluntary 
     insurance coverage or pursuant to statutory or contractual 
     obligation, of health care costs for retired individuals (or 
     for such individuals and their spouses and dependents) based 
     on their status as former employees or labor union members.
       ``(2) Employer.--The term `employer' has the meaning given 
     the term in section 3(5) of the Employee Retirement Income 
     Security Act of 1974 (except that such term shall include 
     only employers of 2 or more employees).
       ``(3) Qualified retiree prescription drug plan.--The term 
     `qualified retiree prescription drug plan' means health 
     insurance coverage included in employment-based retiree 
     health coverage that--
       ``(A) provides coverage of the cost of prescription drugs 
     with an actuarial value (as defined by the Secretary) to each 
     retired beneficiary that equals or exceeds the actuarial 
     value of the benefits provided to an individual enrolled in 
     the outpatient prescription drug benefit program under this 
     part; and
       ``(B) does not deny, limit, or condition the coverage or 
     provision of prescription drug benefits for retired 
     individuals based on age or any health status-related factor 
     described in section 2702(a)(1) of the Public Health Service 
     Act.
       ``(4) Sponsor.--The term `sponsor' has the meaning given 
     the term `plan sponsor' in section 3(16)(B) of the Employer 
     Retirement Income Security Act of 1974.
       ``(f) Authorization of Appropriations.--There are 
     authorized to be appropriated from time to time, out of any 
     moneys in the Treasury not otherwise appropriated, such

[[Page 15398]]

     sums as may be necessary to carry out the program under this 
     section.


   ``prescription drug account in the federal supplementary medical 
                          insurance trust fund

       ``Sec. 1860K. (a) Establishment.--
       ``(1) In general.--There is created within the Federal 
     Supplementary Medical Insurance Trust Fund established by 
     section 1841 an account to be known as the `Prescription Drug 
     Account' (in this section referred to as the `Account').
       ``(2) Funds.--The Account shall consist of such gifts and 
     bequests as may be made as provided in section 201(i)(1), and 
     such amounts as may be deposited in, or appropriated to, the 
     account as provided in this part.
       ``(3) Separate from rest of trust fund.--Funds provided 
     under this part to the Account shall be kept separate from 
     all other funds within the Federal Supplementary Medical 
     Insurance Trust Fund.
       ``(b) Payments From Account.--
       ``(1) In general.--The Managing Trustee shall pay from time 
     to time from the Account such amounts as the Secretary 
     certifies are necessary to make payments to operate the 
     program under this part, including payments to eligible 
     entities under section 1860I, payments to Medicare+Choice 
     organizations under section 1853(c)(8), and payments with 
     respect to administrative expenses under this part in 
     accordance with section 201(g).
       ``(2) Treatment in relation to part b premium.--Amounts 
     payable from the Account shall not be taken into account in 
     computing actuarial rates or premium amounts under section 
     1839.
       ``(c) Appropriations To Cover Benefits and Administrative 
     Costs.--There are appropriated to the Account in a fiscal 
     year, out of any moneys in the Treasury not otherwise 
     appropriated, an amount equal to the amount by which the 
     benefits and administrative costs of providing the benefits 
     under this part in the year exceed the annual enrollment fees 
     collected under section 1860E(b) for the year.


            ``medicare prescription drug advisory committee

       ``Sec. 1860L. (a) Establishment of Committee.--There is 
     established a Medicare Prescription Drug Advisory Committee 
     (in this section referred to as the `Committee').
       ``(b) Functions of Committee.--On and after January 1, 
     2004, the Committee shall advise the Secretary on policies 
     related to--
       ``(1) the development of guidelines for the implementation 
     and administration of the outpatient prescription drug 
     benefit program under this part; and
       ``(2) the development of--
       ``(A) standards for a pharmacy and therapeutics committee 
     required of eligible entities under section 1860H(c)(2)(A);
       ``(B) standards required under subparagraphs (D) and (E) of 
     section 1860H(a)(4) for determining if a drug is medically 
     necessary;
       ``(C) standards for--
       ``(i) establishing therapeutic categories and classes of 
     covered outpatient drugs;
       ``(ii) adding new therapeutic categories and classes of 
     covered outpatient drugs to a formulary; and
       ``(iii) defining maintenance and nonmaintenance drugs and 
     determining the length of the course that is typical of 
     current practice for nonmaintenance drugs for purposes of 
     applying section 1860F(b)(3);
       ``(D) procedures to evaluate the bids submitted by eligible 
     entities under this part; and
       ``(E) procedures to ensure that eligible entities with a 
     contract under this part are in compliance with the 
     requirements under this part.
       ``(c) Structure and Membership of the Committee.--
       ``(1) Structure.--The Committee shall be composed of 19 
     members who shall be appointed by the Secretary.
       ``(2) Membership.--
       ``(A) In general.--The members of the Committee shall be 
     chosen on the basis of their integrity, impartiality, and 
     good judgment, and shall be individuals who are, by reason of 
     their education, experience, attainments, and understanding 
     of pharmaceutical cost control and quality enhancement, 
     exceptionally qualified to perform the duties of members of 
     the Committee.
       ``(B) Specific members.--Of the members appointed under 
     paragraph (1)--
       ``(i) five shall be chosen to represent physicians, 2 of 
     whom shall be geriatricians;
       ``(ii) two shall be chosen to represent nurse 
     practitioners;
       ``(iii) four shall be chosen to represent pharmacists;
       ``(iv) one shall be chosen to represent the Centers for 
     Medicare & Medicaid Services;
       ``(v) four shall be chosen to represent actuaries, 
     pharmacoeconomists, researchers, and other appropriate 
     experts;
       ``(vi) one shall be chosen to represent emerging drug 
     technologies;
       ``(vii) one shall be chosen to represent the Food and Drug 
     Administration; and
       ``(viii) one shall be chosen to represent individuals 
     enrolled under this part.
       ``(d) Terms of Appointment.--Each member of the Committee 
     shall serve for a term determined appropriate by the 
     Secretary. The terms of service of the members initially 
     appointed shall begin on March 1, 2003.
       ``(e) Chairperson.--The Secretary shall designate a member 
     of the Committee as Chairperson. The term as Chairperson 
     shall be for a 1-year period.
       ``(f) Committee Personnel Matters.--
       ``(1) Members.--
       ``(A) Compensation.--Each member of the Committee who is 
     not an officer or employee of the Federal Government shall be 
     compensated at a rate equal to the daily equivalent of the 
     annual rate of basic pay prescribed for level IV of the 
     Executive Schedule under section 5315 of title 5, United 
     States Code, for each day (including travel time) during 
     which such member is engaged in the performance of the duties 
     of the Committee. All members of the Committee who are 
     officers or employees of the United States shall serve 
     without compensation in addition to that received for their 
     services as officers or employees of the United States.
       ``(B) Travel expenses.--The members of the Committee shall 
     be allowed travel expenses, including per diem in lieu of 
     subsistence, at rates authorized for employees of agencies 
     under subchapter I of chapter 57 of title 5, United States 
     Code, while away from their homes or regular places of 
     business in the performance of services for the Committee.
       ``(2) Staff.--The Committee may appoint such personnel as 
     the Committee considers appropriate.
       ``(g) Operation of the Committee.--
       ``(1) Meetings.--The Committee shall meet at the call of 
     the Chairperson (after consultation with the other members of 
     the Committee) not less often than quarterly to consider a 
     specific agenda of issues, as determined by the Chairperson 
     after such consultation.
       ``(2) Quorum.--Ten members of the Committee shall 
     constitute a quorum for purposes of conducting business.
       ``(h) Federal Advisory Committee Act.--Section 14 of the 
     Federal Advisory Committee Act (5 U.S.C. App.) shall not 
     apply to the Committee.
       ``(i) Transfer of Personnel, Resources, and Assets.--For 
     purposes of carrying out its duties, the Secretary and the 
     Committee may provide for the transfer to the Committee of 
     such civil service personnel in the employ of the Department 
     of Health and Human Services (including the Centers for 
     Medicare & Medicaid Services), and such resources and assets 
     of the Department used in carrying out this title, as the 
     Committee requires.
       ``(j) Authorization of Appropriations.--There are 
     authorized to be appropriated such sums as may be necessary 
     to carry out the purposes of this section.''.
       (b) Exclusions From Coverage.--
       (1) Application to part d.--Section 1862(a) of the Social 
     Security Act (42 U.S.C. 1395y(a)) is amended in the matter 
     preceding paragraph (1) by striking ``part A or part B'' and 
     inserting ``part A, B, or D''.
       (2) Prescription drugs not excluded from coverage if 
     reasonable and necessary.--Section 1862(a)(1) of the Social 
     Security Act (42 U.S.C. 1395y(a)(1)) is amended--
       (A) in subparagraph (H), by striking ``and'' at the end;
       (B) in subparagraph (I), by striking the semicolon at the 
     end and inserting ``, and''; and
       (C) by adding at the end the following new subparagraph:
       ``(J) in the case of prescription drugs covered under part 
     D, which are not reasonable and necessary to prevent or slow 
     the deterioration of, or improve or maintain, the health of 
     eligible beneficiaries;''.
       (c) Conforming Amendments to Federal Supplementary Medical 
     Insurance Trust Fund.--Section 1841 of the Social Security 
     Act (42 U.S.C. 1395t) is amended--
       (1) in the last sentence of subsection (a)--
       (A) by striking ``and'' before ``such amounts''; and
       (B) by inserting before the period the following: ``, and 
     such amounts as may be deposited in, or appropriated to, the 
     Prescription Drug Account established by section 1860K'';
       (2) in subsection (g), by inserting after ``by this part,'' 
     the following: ``the payments provided for under part D (in 
     which case the payments shall be made from the Prescription 
     Drug Account in the Trust Fund),'';
       (3) in subsection (h), by inserting after ``1840(d)'' the 
     following: ``and section 1860E(b)(3) (in which case the 
     payments shall be made from the Prescription Drug Account in 
     the Trust Fund)''; and
       (4) in subsection (i), by inserting after ``section 
     1840(b)(1)'' the following: ``, section 1860E(b)(3) (in which 
     case the payments shall be made from the Prescription Drug 
     Account in the Trust Fund),''.
       (d) Conforming References to Previous Part D.--
       (1) In general.--Any reference in law (in effect before the 
     date of enactment of this Act) to part D of title XVIII of 
     the Social Security Act is deemed a reference to part E of 
     such title (as in effect after such date).
       (2) Secretarial submission of legislative proposal.--Not 
     later than 6 months after the date of enactment of this Act, 
     the Secretary of Health and Human Services shall submit to 
     Congress a legislative proposal

[[Page 15399]]

     providing for such technical and conforming amendments in the 
     law as are required by the provisions of this title.

     SEC. 203. PART D BENEFITS UNDER MEDICARE+CHOICE PLANS.

       (a) Eligibility, Election, and Enrollment.--Section 1851 of 
     the Social Security Act (42 U.S.C. 1395w-21) is amended--
       (1) in subsection (a)(1)(A), by striking ``parts A and B'' 
     and inserting ``parts A, B, and D''; and
       (2) in subsection (i)(1), by striking ``parts A and B'' and 
     inserting ``parts A, B, and D''.
       (b) Voluntary Beneficiary Enrollment for Drug Coverage.--
     Section 1852(a)(1)(A) of the Social Security Act (42 U.S.C. 
     1395w-22(a)(1)(A)) is amended by inserting ``(and under part 
     D to individuals also enrolled under that part)'' after 
     ``parts A and B''.
       (c) Access to Services.--Section 1852(d)(1) of the Social 
     Security Act (42 U.S.C. 1395w-22(d)(1)) is amended--
       (1) in subparagraph (D), by striking ``and'' at the end;
       (2) in subparagraph (E), by striking the period at the end 
     and inserting ``; and''; and
       (3) by adding at the end the following new subparagraph:
       ``(F) in the case of covered outpatient drugs (as defined 
     in section 1860(1)) provided to individuals enrolled under 
     part D, the organization complies with the access 
     requirements applicable under part D.''.
       (d) Payments to Organizations for Part D Benefits.--
       (1) In general.--Section 1853(a)(1)(A) of the Social 
     Security Act (42 U.S.C. 1395w-23(a)(1)(A)) is amended--
       (A) by inserting ``determined separately for the benefits 
     under parts A and B and under part D (for individuals 
     enrolled under that part)'' after ``as calculated under 
     subsection (c)'';
       (B) by striking ``that area, adjusted for such risk 
     factors'' and inserting ``that area. In the case of payment 
     for the benefits under parts A and B, such payment shall be 
     adjusted for such risk factors as''; and
       (C) by inserting before the last sentence the following: 
     ``In the case of the payments under subsection (c)(8) for the 
     provision of coverage of covered outpatient drugs to 
     individuals enrolled under part D, such payment shall be 
     adjusted for the risk factors of each enrollee as the 
     Secretary determines to be feasible and appropriate to ensure 
     actuarial equivalence.''.
       (2) Amount.--Section 1853(c) of the Social Security Act (42 
     U.S.C. 1395w-23(c)) is amended--
       (A) in paragraph (1), in the matter preceding subparagraph 
     (A), by inserting ``for benefits under parts A and B'' after 
     ``capitation rate''; and
       (B) by adding at the end the following new paragraph:
       ``(8) Capitation rate for part d benefits.--
       ``(A) In general.--In the case of a Medicare+Choice plan 
     that provides coverage of covered outpatient drugs to an 
     individual enrolled under part D, the capitation rate for 
     such coverage shall be the amount described in subparagraph 
     (B). Such payments shall be made in the same manner and at 
     the same time as the payments to the Medicare+Choice 
     organization offering the plan for benefits under parts A and 
     B are otherwise made, but such payments shall be payable from 
     the Prescription Drug Account in the Federal Supplementary 
     Medical Insurance Trust Fund under section 1841.
       ``(B) Amount.--The amount described in this paragraph is an 
     amount equal to \1/12\ of the average annual per capita 
     aggregate expenditures payable from the Prescription Drug 
     Account for the year (as estimated under section 
     1860J(c)(2)(C)).''.
       (e) Limitation on Enrollee Liability.--Section 1854(e) of 
     the Social Security Act (42 U.S.C. 1395w-24(e)) is amended by 
     adding at the end the following new paragraph:
       ``(5) Special rule for part d benefits.--With respect to 
     outpatient prescription drug benefits under part D, a 
     Medicare+Choice organization may not require that an enrollee 
     pay any deductible or pay a cost-sharing amount that exceeds 
     the amount of cost-sharing applicable for such benefits for 
     an eligible beneficiary under part D.''.
       (f) Requirement for Additional Benefits.--Section 
     1854(f)(1) of the Social Security Act (42 U.S.C. 1395w-
     24(f)(1)) is amended by adding at the end the following new 
     sentence: ``Such determination shall be made separately for 
     the benefits under parts A and B and for prescription drug 
     benefits under part D.''.
       (g) Effective Date.--The amendments made by this section 
     shall apply to items and services provided under a 
     Medicare+Choice plan on or after January 1, 2005.

     SEC. 204. ADDITIONAL ASSISTANCE FOR LOW-INCOME BENEFICIARIES.

       (a) Inclusion in Medicare Cost-Sharing.--
       (1) In general.--Section 1905(p)(3) of the Social Security 
     Act (42 U.S.C. 1396d(p)(3)) is amended--
       (A) in subparagraph (B), by inserting ``and, subject to 
     paragraph (7), cost-sharing described in section 1860F(b), 
     subject to payment by the individual of a cost-sharing charge 
     for the dispensing of a covered outpatient drug (as defined 
     in section 1860(1)) that is equal to $2 for a prescription 
     (as defined in section 1860F(b)(3)(D)) of a generic drug and 
     $5 for a prescription (as so defined) of a brand name drug'' 
     after ``section 1813''; and
       (B) by inserting after subparagraph (D) the following new 
     subparagraph:
       ``(E) The annual enrollment fee under section 1860E(b).''.
       (2) Indexing.--Section 1905(p) of the Social Security Act 
     (42 U.S.C. 1396d(p)) is amended--
       (A) by redesignating paragraph (6) as paragraph (8); and
       (B) by inserting after paragraph (5) the following new 
     paragraph:
       ``(6)(A) For any year after 2005, the cost-sharing amounts 
     specified in paragraph (3)(B) for covered outpatient drugs 
     (as defined in section 1860(1)) are equal to the cost-sharing 
     amounts for such drugs determined under such paragraph (or 
     this paragraph) for the previous year increased by the annual 
     percentage increase described in section 1860E(b)(2)(B).
       ``(B) If any amount determined under subparagraph (A) is 
     not a multiple of $1, such amount shall be rounded to the 
     nearest multiple of $1.''.
       (b) Expansion of Medical Assistance.--Section 
     1902(a)(10)(E) of the Social Security Act (42 U.S.C. 
     1396a(a)(10)(E)) is amended--
       (1) in clause (iii)--
       (A) by inserting after ``section 1905(p)(3)(A)(ii)'' the 
     following: ``, for medicare cost-sharing described in section 
     1905(p)(3)(B) (but only insofar as it relates to benefits 
     provided under part D of title XVIII), and for medicare cost-
     sharing described in section 1905(p)(3)(E),''; and
       (B) by striking ``and'' at the end;
       (2) by redesignating clause (iv) as clause (v); and
       (3) by inserting after clause (iii) the following new 
     clause:
       ``(iv) for making medical assistance available for medicare 
     cost-sharing described in section 1905(p)(3)(B) (but only 
     insofar as it relates to benefits provided under part D of 
     title XVIII) and for medicare cost-sharing described in 
     section 1905(p)(3)(E) for--
       ``(I) individuals who would be qualified medicare 
     beneficiaries described in section 1905(p)(1) but for the 
     fact that their income exceeds 120 percent but does not 
     exceed 150 percent of the official poverty line (referred to 
     in section 1905(p)(2)) for a family of the size involved; and
       ``(II) individuals who would be qualified medicare 
     beneficiaries described in section 1905(p)(1) but for the 
     fact that their income exceeds 150 percent but does not 
     exceed 200 percent of the official poverty line (referred to 
     in section 1905(p)(2)) for a family of the size involved; 
     and''.
       (c) Nondiscrimination.--Section 1905(p) of the Social 
     Security Act (42 U.S.C. 1396d(p)), as amended by subsection 
     (a)(2), is amended by inserting after paragraph (6) the 
     following new paragraph:
       ``(7) With respect to determining the eligibility of 
     individuals described in clause (i), (iii), or (iv) of 
     section 1902(a)(10)(E) for medicare cost-sharing described in 
     paragraph (3)(B) (but only insofar as it relates to benefits 
     provided under part D of title XVIII) and for medicare cost-
     sharing described in paragraph (3)(E), the State shall--
       ``(A) use the same methodology in determining income 
     eligibility for all such individuals;
       ``(B) use the same simplified eligibility form (including, 
     if applicable, permitting application other than in person) 
     for all such individuals;
       ``(C) provide for initial eligibility determinations and 
     redeterminations and renewals of eligibility using the same 
     verification policies, forms, and frequency for all such 
     individuals; and
       ``(D) use the same face-to-face interview policy 
     (including, if applicable, not requiring such an interview) 
     for purposes of initial eligibility determinations and 
     redeterminations, and renewals for all such individuals.''.
       (d) Nonapplicability of Resource Requirements to Medicare 
     Part D Cost-Sharing.--Section 1905(p)(1) of the Social 
     Security Act (42 U.S.C. 1396d(p)(1)) is amended by adding at 
     the end the following flush sentence:

     ``In determining if an individual is a qualified medicare 
     beneficiary under this paragraph, subparagraph (C) shall not 
     be applied for purposes of providing the individual with 
     medicare cost-sharing described in section 1905(p)(3)(B) (but 
     only insofar as it relates to benefits provided under part D 
     of title XVIII) or with medicare cost-sharing described in 
     section 1905(p)(3)(E).''.
       (e) Nonapplicability of Payment Differential Requirements 
     to Medicare Part D Cost-Sharing.--Section 1902(n)(2) of the 
     Social Security Act (42 U.S.C. 1396a(n)(2)) is amended by 
     adding at the end the following new sentence: ``The preceding 
     sentence shall not apply to the cost-sharing described in 
     section 1860F(b).''.
       (f) Increased Federal Matching Assistance Percentage for 
     Certain Individuals.--
       (1) Use of enhanced fmap for individuals with incomes that 
     exceed 120 percent, but do not exceed 150 percent, of the 
     poverty line.--The first sentence of section 1905(b) of the 
     Social Security Act (42 U.S.C. 1396d(b)(4)) is amended--

[[Page 15400]]

       (A) in paragraph (4), by inserting ``(A)'' after 
     ``2105(b)''; and
       (B) by inserting before the period at the end the 
     following: ``, and (B) with respect to medicare cost-sharing 
     described in subparagraph (B) of section 1905(p)(3) (but only 
     insofar as it relates to benefits provided under part D of 
     title XVIII) and medicare cost-sharing described in 
     subparagraph (E) of that section, but only in the case of 
     individuals who are eligible for such assistance on the basis 
     of clause (iv)(I) of section 1902(a)(10)(E)''.
       (2) 100 percent federal matching assistance percentage for 
     individuals with incomes that exceed 150 percent, but do not 
     exceed 200 percent, of the poverty line.--The first sentence 
     of section 1905(b) of the Social Security Act (42 U.S.C. 
     1396d(b)(4)), as amended by paragraph (1), is amended--
       (A) by striking ``and'' before ``(4)''; and
       (B) by inserting before the period at the end the 
     following: ``, and (5) the Federal medical assistance 
     percentage shall be 100 percent with respect to medicare 
     cost-sharing described in subparagraph (B) of section 
     1905(p)(3) (but only insofar as it relates to benefits 
     provided under part D of title XVIII) and medicare cost-
     sharing described in subparagraph (E) of that section, but 
     only in the case of individuals who are eligible for such 
     assistance on the basis of clause (iv)(II) of section 
     1902(a)(10)(E)''.
       (g) Treatment of Territories.--Section 1108(g) of the 
     Social Security Act (42 U.S.C. 1308(g)) is amended by adding 
     at the end the following new paragraph:
       ``(3) Notwithstanding the preceding provisions of this 
     subsection, with respect to fiscal year 2005 and any fiscal 
     year thereafter, the amount otherwise determined under this 
     subsection (and subsection (f)) for the fiscal year for a 
     Commonwealth or territory shall be increased by the ratio (as 
     estimated by the Secretary) of--
       ``(A) the aggregate amount of payments made to the 50 
     States and the District of Columbia for the fiscal year under 
     title XIX that are attributable to making medical assistance 
     available for individuals described in clauses (i), (iii), 
     and (iv) of section 1902(a)(10)(E) for payment of medicare 
     cost-sharing described in section 1905(p)(3)(B) (but only 
     insofar as it relates to benefits provided under part D of 
     title XVIII) and medicare cost-sharing described in section 
     1905(p)(3)(E); to
       ``(B) the aggregate amount of total payments made to such 
     States and District for the fiscal year under such title 
     XIX.''.
       (h) Amendment to Best Price.--Section 1927(c)(1)(C)(i) of 
     the Social Security Act (42 U.S.C. 1396r-8(c)(1)(C)(i)) is 
     amended--
       (1) by striking ``and'' at the end of subclause (III);
       (2) by striking the period at the end of subclause (IV) and 
     inserting ``; and''; and
       (3) by adding at the end the following new subclause:

       ``(V) any prices charged which are negotiated under a plan 
     under part D of title XVIII with respect to covered 
     outpatient drugs, under a Medicare+Choice plan under part C 
     of such title with respect to such drugs, or by a qualified 
     retiree prescription drug plan (as defined in section 
     1860J(e)(3)) with respect to such drugs, on behalf of 
     eligible beneficiaries (as defined in section 1860(2)).''.

       (i) Conforming Amendments.--Section 1933 of the Social 
     Security Act (42 U.S.C. 1396u-3) is amended--
       (1) in subsection (a), by striking ``section 
     1902(a)(10)(E)(iv)'' and inserting ``section 
     1902(a)(10)(E)(v)'';
       (2) in subsection (c)(2)(A)--
       (A) in clause (i), by striking ``section 
     1902(a)(10)(E)(iv)(I)'' and inserting ``section 
     1902(a)(10)(E)(v)(I)''; and
       (B) in clause (ii), by striking ``section 
     1902(a)(10)(E)(iv)(II)'' and inserting ``section 
     1902(a)(10)(E)(v)(II)'';
       (3) in subsection (d), by striking ``section 
     1902(a)(10)(E)(iv)'' and inserting ``section 
     1902(a)(10)(E)(v)''; and
       (4) in subsection (e), by striking ``section 
     1902(a)(10)(E)(iv)'' and inserting ``section 
     1902(a)(10)(E)(v)''.
       (j) Effective Date.--The amendments made by this section 
     shall apply to medical assistance provided under section 
     1902(a)(10)(E) of the Social Security Act (42 U.S.C. 
     1396a(a)(10)(E)) on and after January 1, 2005.
       (k) Rule of Construction.--Nothing in the amendments made 
     by this section shall be construed as precluding a State from 
     using State funds to provide coverage of outpatient 
     prescription drugs that is in addition to the coverage of 
     such drugs required under title XIX of the Social Security 
     Act (42 U.S.C. 1396 et seq.), as amended by this section.
       (l) Sense of the Senate.--It is the sense of the Senate 
     that during consideration of any conference report for this 
     legislation, conferees should explore ways to provide 
     incentives to States (and in particular to those States that, 
     as of the date of enactment of this Act, offer some form of 
     prescription drug assistance to the elderly and the disabled) 
     to maintain existing State commitments to provide 
     prescription drug assistance to the elderly and disabled or 
     to supplement the drug benefit established by the conference 
     report.

     SEC. 205. MEDIGAP REVISIONS.

       Section 1882 of the Social Security Act (42 U.S.C. 1395ss) 
     is amended by adding at the end the following new subsection:
       ``(v) Modernized Benefit Packages for Medicare Supplemental 
     Policies.--
       ``(1) Revision of benefit packages.--
       ``(A) In general.--Notwithstanding subsection (p), the 
     benefit packages classified as `H', `I', and `J' under the 
     standards established by subsection (p)(2) (including the 
     benefit package classified as `J' with a high deductible 
     feature, as described in subsection (p)(11)) shall be revised 
     so that--
       ``(i) the coverage of outpatient prescription drugs 
     available under such benefit packages is replaced with 
     coverage of outpatient prescription drugs that complements 
     but does not duplicate the coverage of outpatient 
     prescription drugs that is otherwise available under this 
     title;
       ``(ii) the revised benefit packages provide a range of 
     coverage options for outpatient prescription drugs for 
     beneficiaries, but do not provide coverage for more than 90 
     percent of the cost-sharing amount applicable to an 
     individual under section 1860F(b);
       ``(iii) uniform language and definitions are used with 
     respect to such revised benefits;
       ``(iv) uniform format is used in the policy with respect to 
     such revised benefits;
       ``(v) such revised standards meet any additional 
     requirements imposed by the amendments made by the Medicare 
     Outpatient Prescription Drug Act of 2002; and
       ``(vi) except as revised under the preceding clauses or as 
     provided under subsection (p)(1)(E), the benefit packages are 
     identical to the benefit packages that were available on the 
     date of enactment of the Medicare Outpatient Prescription 
     Drug Act of 2002.
       ``(B) Manner of revision.--The benefit packages revised 
     under this section shall be revised in the manner described 
     in subparagraph (E) of subsection (p)(1), except that for 
     purposes of subparagraph (C) of such subsection, the 
     standards established under this subsection shall take effect 
     not later than January 1, 2005.
       ``(2) Construction of benefits in other medicare 
     supplemental policies.--Nothing in the benefit packages 
     classified as `A' through `G' under the standards established 
     by subsection (p)(2) (including the benefit package 
     classified as `F' with a high deductible feature, as 
     described in subsection (p)(11)) shall be construed as 
     providing coverage for benefits for which payment may be made 
     under part D.
       ``(3) Guaranteed issuance and renewal of revised 
     policies.--The provisions of subsections (q) and (s), 
     including provisions of subsection (s)(3) (relating to 
     special enrollment periods in cases of termination or 
     disenrollment), shall apply to medicare supplemental policies 
     revised under this subsection in the same manner as such 
     provisions apply to medicare supplemental policies issued 
     under the standards established under subsection (p).
       ``(4) Opportunity of current policyholders to purchase 
     revised policies.--
       ``(A) In general.--No medicare supplemental policy of an 
     issuer with a benefit package that is revised under paragraph 
     (1) shall be deemed to meet the standards in subsection (c) 
     unless the issuer--
       ``(i) provides written notice during the 60-day period 
     immediately preceding the open enrollment period established 
     under section 1860B(a)(3), to each individual who is a 
     policyholder or certificate holder of a medicare supplemental 
     policy issued by that issuer (at the most recent available 
     address of that individual) of the offer described in clause 
     (ii) and of the fact that such individual will no longer be 
     covered under such policy as of January 1, 2005; and
       ``(ii) offers the policyholder or certificate holder under 
     the terms described in subparagraph (B), during at least the 
     period established under section 1860B(a)(3), a medicare 
     supplemental policy with the benefit package that the 
     Secretary determines is most comparable to the policy in 
     which the individual is enrolled with coverage effective as 
     of the date on which the individual is first entitled to 
     benefits under part D.
       ``(B) Terms of offer described.--The terms described in 
     this subparagraph are terms which do not--
       ``(i) deny or condition the issuance or effectiveness of a 
     medicare supplemental policy described in subparagraph 
     (A)(ii) that is offered and is available for issuance to new 
     enrollees by such issuer;
       ``(ii) discriminate in the pricing of such policy because 
     of health status, claims experience, receipt of health care, 
     or medical condition; or
       ``(iii) impose an exclusion of benefits based on a 
     preexisting condition under such policy.
       ``(5) Elimination of obsolete policies with no 
     grandfathering.--No person may sell, issue, or renew a 
     medicare supplemental policy with a benefit package that is 
     classified as `H', `I', or `J' (or with a benefit package 
     classified as `J' with a high deductible feature) that has 
     not been revised under this subsection on or after January 1, 
     2005.
       ``(6) Penalties.--Each penalty under this section shall 
     apply with respect to policies revised under this subsection 
     as if such policies were issued under the standards 
     established under subsection (p), including the penalties 
     under subsections (a), (d), (p)(8), (p)(9), (q)(5), 
     (r)(6)(A), (s)(4), and (t)(2)(D).''.

[[Page 15401]]



     SEC. 206. COMPREHENSIVE IMMUNOSUPPRESSIVE DRUG COVERAGE FOR 
                   TRANSPLANT PATIENTS UNDER PART B.

       (a) In General.--Section 1861(s)(2)(J) of the Social 
     Security Act (42 U.S.C. 1395x(s)(2)(J)), as amended by 
     section 113(a) of the Medicare, Medicaid, and SCHIP Benefits 
     Improvement and Protection Act of 2000 (114 Stat. 2763A-473), 
     as enacted into law by section 1(a)(6) of Public Law 106-554, 
     is amended by striking ``, to an individual who receives'' 
     and all that follows before the semicolon at the end and 
     inserting ``to an individual who has received an organ 
     transplant''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall apply to drugs furnished on or after the date of 
     enactment of this Act.

     SEC. 207. HHS STUDY AND REPORT ON UNIFORM PHARMACY BENEFIT 
                   CARDS.

       (a) Studies.--The Secretary of Health and Human Services 
     shall conduct a study to determine the feasibility and 
     advisability of establishing a uniform format for pharmacy 
     benefit cards provided to beneficiaries by eligible entities 
     under the outpatient prescription drug benefit program under 
     part D of title XVIII of the Social Security Act (as added by 
     section 202).
       (b) Report.--Not later than 2 years after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall submit to Congress a report on the results of 
     the study conducted under subsection (a) together with any 
     recommendations for legislation that the Secretary determines 
     to be appropriate as a result of such study.

     SEC. 208. GAO STUDY AND BIENNIAL REPORTS ON COMPETITION AND 
                   SAVINGS.

       (a) Ongoing Study.--The Comptroller General of the United 
     States shall conduct an ongoing study and analysis of the 
     outpatient prescription drug benefit program under part D of 
     title XVIII of the Social Security Act (as added by section 
     202), including an analysis of--
       (1) the extent to which the competitive bidding process 
     under such program fosters maximum competition and 
     efficiency; and
       (2) the savings to the medicare program resulting from such 
     outpatient prescription drug benefit program, including the 
     reduction in the number or length of hospital visits.
       (b) Initial Report on Competitive Bidding Process.--Not 
     later than 9 months after the date of enactment of this Act, 
     the Comptroller General of the United States shall submit to 
     Congress a report on the results of the portion of the study 
     conducted pursuant to subsection (a)(1).
       (c) Biennial Reports.--Not later than January 1, 2006, and 
     biennially thereafter, the Comptroller General of the United 
     States shall submit to Congress a report on the results of 
     the study conducted under subsection (a) together with such 
     recommendations for legislation and administrative action as 
     the Comptroller General determines appropriate.

     SEC. 209. EXPANSION OF MEMBERSHIP AND DUTIES OF MEDICARE 
                   PAYMENT ADVISORY COMMISSION (MEDPAC).

       (a) Expansion of Membership.--
       (1) In general.--Section 1805(c) of the Social Security Act 
     (42 U.S.C. 1395b-6(c)) is amended--
       (A) in paragraph (1), by striking ``17'' and inserting 
     ``19''; and
       (B) in paragraph (2)(B), by inserting ``experts in the area 
     of pharmacology and prescription drug benefit programs,'' 
     after ``other health professionals,''.
       (2) Initial terms of additional members.--
       (A) In general.--For purposes of staggering the initial 
     terms of members of the Medicare Payment Advisory Commission 
     under section 1805(c)(3) of the Social Security Act (42 
     U.S.C. 1395b-6(c)(3)), the initial terms of the 2 additional 
     members of the Commission provided for by the amendment under 
     paragraph (1)(A) are as follows:
       (i) One member shall be appointed for 1 year.
       (ii) One member shall be appointed for 2 years.
       (B) Commencement of terms.--Such terms shall begin on 
     January 1, 2004.
       (b) Expansion of Duties.--Section 1805(b)(2) of the Social 
     Security Act (42 U.S.C. 1395b-6(b)(2)) is amended by adding 
     at the end the following new subparagraph:
       ``(D) Prescription medicine benefit program.--Specifically, 
     the Commission shall review, with respect to the outpatient 
     prescription drug benefit program under part D, the impact of 
     such program on--
       ``(i) the pharmaceutical market, including costs and 
     pricing of pharmaceuticals, beneficiary access to such 
     pharmaceuticals, and trends in research and development;
       ``(ii) franchise, independent, and rural pharmacies; and
       ``(iii) beneficiary access to outpatient prescription 
     drugs, including an assessment of out-of-pocket spending, 
     generic and brand name drug utilization, and pharmacists' 
     services.''.
                                 ______
                                 
  SA 4346. Ms. LANDRIEU submitted an amendment intended to be proposed 
by her to the bill H.R. 5010, making appropriations for the Department 
of Defense for the fiscal year ending September 30, 2003, and for other 
purposes; which was ordered to lie on the table; as follows:

       On page 223, between lines 20 and 21, insert the following:
       Sec. 8124. Of the amount appropriated by title II under the 
     heading ``Operation and Maintenance, Navy'', up to $4,000,000 
     may be available for Configuration Management Information 
     Systems.
                                 ______
                                 
  SA 4347. Ms. LANDRIEU submitted an amendment intended to be proposed 
by her to the bill H.R. 5010, making appropriations for the Department 
of Defense for the fiscal year ending September 30, 2003, and for other 
purposes; which was ordered to lie on the table; as follows:

       On page 223, between lines 20 and 21, insert the following:
       Sec. 8124. Of the amount appropriated by title II under the 
     heading ``Operation and Maintenance, Army'', up to $5,000,000 
     may be available for the Field Pack-up Containerized Storage 
     Unit.
                                 ______
                                 
  SA 4348. Ms. LANDRIEU submitted an amendment intended to be proposed 
by her to the bill H.R. 5010, making appropriations for the Department 
of Defense for the fiscal year ending September 30, 2003, and for other 
purposes; which was ordered to lie on the table; as follows:

       On page 223, between lines 20 and 21, insert the following:
       Sec. 8124. The Secretary of Defense may, using amounts 
     appropriated or otherwise made available by this Act, make a 
     grant to the National D-Day Museum in the amount of 
     $5,000,000.
                                 ______
                                 
  SA 4349. Mr. HUTCHINSON submitted an amendment intended to be 
proposed to amendment SA 4345 proposed by Mr. Graham (for himself, Mr. 
Smith of Oregon, Mr. Miller, Mrs. Lincoln, Mr. Bingaman, Mr. Kennedy, 
and Ms. Stabenow) to the amendment SA 4299 proposed by Mr. Reid (for 
Mr. Dorgan (for himself, Mr. Wellstone, Mr. Jeffords, Ms. Stabenow, Ms. 
Collins, Mr. Levin, Mr. Johnson, Mr. Miller, Mr. Durbin, Mr. Feingold, 
and Mr. Harkin) to the bill (S. 812) to amend the Federal Food, Drug, 
and Cosmetic Act to provide greater access to affordable 
pharmaceuticals; which was ordered to lie on the table; as follows:

       On Page 21, strike lines 6 through 20.
       On Page 24, strike lines 14 through 22.
       On Page 26, strike lines 18 through 25.
       On Page 27, strike lines 1 through 3.
       On Page 57, strike lines 1 through 25.
       On Page 58, strike lines 1 through 22.

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