[Congressional Record Volume 149, Number 91 (Thursday, June 19, 2003)]
[Senate]
[Pages S8246-S8255]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 936. Mr. NELSON of Florida submitted an amendment intended to be 
proposed by him to the bill S. 1, to amend title XVIII of the Social 
Security Act to make improvements in the medicare program, to provide 
prescription drug coverage under the medicare program, and for other 
purposes; which was ordered to lie on the table, as follows:

       At the end of subtitle C of title II, add the following:

     SEC. __. EXTENSION OF DEMONSTRATION FOR ESRD MANAGED CARE.

       The Secretary shall extend without interruption, through 
     December 31, 2007, the approval of the demonstration project, 
     Contract No. H1021, under the authority of section 
     2355(b)(1)(B)(iv) of the Deficit Reduction Act of 1984, as 
     amended by section 13567 of the Omnibus Reconciliation Act of 
     1993. Such approval shall be subject to the terms and 
     conditions in effect for the 2002 project year with respect 
     to eligible participants and covered benefits. The Secretary 
     shall set the monthly capitation rate for enrollees on the 
     basis of the reasonable medical and direct administrative 
     costs of providing those benefits to such participants.
                                 ______
                                 
  SA 937. Mr. NELSON of Florida submitted an amendment intended to be 
proposed by him to the bill S. 1, to amend title XVIII of the Social 
Security Act to make improvements in the medicare program, to provide 
prescription drug coverage under the medicare program, and for other 
purposes; which was ordered to lie on the table, as follows:

       At the end of subtitle B of title IV, add the following:

     SEC. __. PROHIBITION OF INCIDENTAL FEES AND REQUIRED PURCHASE 
                   OF NONCOVERED ITEMS OR SERVICES UNDER MEDICARE.

       (a) In General.--Section 1842 (42 U.S.C. 1395u) is amended 
     by adding at the end the following new subsection:
       ``(u) Prohibition of Incidental Fees or Requiring Purchase 
     of Noncovered Items or Services.--
       ``(1) In general.--A physician, practitioner (as described 
     in section 1842(b)(18)(C)), or other individual may not--
       ``(A) charge a membership fee or any other incidental fee 
     to a medicare beneficiary (as defined in section 
     1802(b)(5)(A)); or
       ``(B) require a medicare beneficiary (as so defined) to 
     purchase a noncovered item or service,

     as a prerequisite for the provision of a covered item or 
     service to the beneficiary under this title.
       ``(2) Construction.--Nothing in this subsection shall be 
     construed to apply the prohibition under paragraph (1) to a 
     physician, practitioner, or other individual described in 
     such subsection who does not accept any funds under this 
     title.''.

[[Page S8247]]

       (b) Effective Date.--The amendment made by subsection (a) 
     shall apply to membership fees and other charges made, or 
     purchases of items and services required, on or after the 
     date of enactment of this Act.
                                 ______
                                 
  SA 938. Mr. NELSON of Florida submitted an amendment intended to be 
proposed by him to the bill S. 1, to amend title XVIII of the Social 
Security Act to make improvements in the medicare program, to provide 
prescription drug coverage under the medicare program, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the end of subtitle B of title IV, add the following:

     SEC. __. GAO STUDY AND REPORT ON THE PROPAGATION OF CONCIERGE 
                   CARE.

       (a) Study.--
       (1) In general.--The Comptroller General of the United 
     States shall conduct a study on concierge care (as defined in 
     paragraph (2)) to determine the extent to which such care--
       (A) is used by medicare beneficiaries (as defined in 
     section 1802(b)(5)(A) of the Social Security Act (42 U.S.C. 
     1395a(b)(5)(A))); and
       (B) has impacted upon the access of medicare beneficiaries 
     (as so defined) to items and services for which reimbursement 
     is provided under the medicare program under title XVIII of 
     the Social Security Act (42 U.S.C. 1395 et seq.).
       (2) Concierge care.--In this section, the term ``concierge 
     care'' means an arrangement under which, as a prerequisite 
     for the provision of a health care item or service to an 
     individual, a physician, practitioner (as described in 
     section 1842(b)(18)(C) of the Social Security Act (42 U.S.C. 
     1395u(b)(18)(C))), or other individual--
       (A) charges a membership fee or another incidental fee to 
     an individual desiring to receive the health care item or 
     service from such physician, practitioner, or other 
     individual; or
       (B) requires the individual desiring to receive the health 
     care item or service from such physician, practitioner, or 
     other individual to purchase an item or service.
       (b) Report.--Not later than the date that is 12 months 
     after the date of enactment of this Act, the Comptroller 
     General of the United States shall submit to Congress a 
     report on the study conducted under subsection (a)(1) 
     together with such recommendations for legislative or 
     administrative action as the Comptroller General determines 
     to be appropriate.
                                 ______
                                 
  SA 939. Mr. DASCHLE (for himself, Mr. Nelson of Nebraska, Ms. 
Mikulski, and Mr. Johnson) proposed an amendment to the bill S. 1, to 
amend title XVIII of the Social Security Act to make improvements in 
the medicare program, to provide prescription drug coverage under the 
medicare program, and for other purposes; as follows:

       On page 103, strike lines 10 though 13 and insert the 
     following:
       ``(B) the lesser of--
       ``(i) the amount by which the monthly plan premium approved 
     by the Administrator for the plan exceeds the amount of the 
     monthly national average premium; or
       ``(ii) in the case of an eligible beneficiary who is 
     enrolled in a Medicare Prescription Drug plan that provides 
     standard prescription drug coverage or an actuarially 
     equivalent prescription drug coverage and does not provide 
     additional prescription drug coverage pursuant to section 
     1860D-6(a)(2), an amount equal to 10 percent of the amount of 
     the monthly national average premium.

       On page 77, strike lines 10 through 22 and insert the 
     following:
       ``(A) In general.--In the case of an eligible beneficiary 
     receiving access to qualified prescription drug coverage 
     through enrollment with an entity with a contract under 
     paragraph (1)(B), the monthly beneficiary obligation of such 
     beneficiary for such enrollment shall be an amount equal to 
     the lesser of--
       ``(i) the applicable percent (for the area in which the 
     beneficiary resides, as determined under section 1860D-17(c)) 
     of the monthly national average premium (as computed under 
     section 1860D-15) for the year as adjusted using the 
     geographic adjuster under subparagraph (B); or
       ``(ii) 110 percent of an amount equal to the applicable 
     percent (as determined under section 1860D-17(c) before any 
     adjustment under paragraph (2) of such section) of the 
     monthly national average premium (as computed under section 
     1860D-15 before any adjustment under subsection (b) of such 
     section) for the year.
                                 ______
                                 
  SA 940. Mr. KERRY submitted an amendment intended to be proposed by 
him to the bill S. 1, to amend title XVIII of the Social Security Act 
to make improvements in the medicare program, to provide prescription 
drug coverage under the medicare program, and for other purposes; which 
was ordered to lie on the table; as follows:

       On page 200, between lines 13 and 14, insert the following:

     SEC. __. ACCESS TO DISCOUNTED PRESCRIPTION DRUGS.

       (a) In General.--From amounts made available under 
     subsection (c), the Secretary of Health and Human Services 
     shall award grants to covered entities described in section 
     340B(a)(4) of the Public Health Service Act (42 U.S.C. 
     256b(a)(4)) to enable such entities to pay the start-up costs 
     associated with the establishment of pharmacies to provide 
     covered drugs under such section 340B.
       (b) Application.--To be eligible to receive a grant under 
     subsection (a), a covered entity shall prepare and submit to 
     the Secretary of Health and Human Services an application at 
     such time, in such manner, and containing such information as 
     the Secretary may require.
       (c) Funding.--There shall be made available from the 
     Prescription Drug Account established under section 1860DD-25 
     of the Social Security Act, $300,000,000 to carry out this 
     section. Amounts made available under this subsection shall 
     remain available until expended.
                                 ______
                                 
  SA 941. Mr. WYDEN (for himself, Mrs. Murray, and Mr. Smith) submitted 
an amendment intended to be proposed by him to the bill S. 1, to amend 
title XVIII of the Social Security Act to make improvements in the 
medicare program, to provide prescription drug coverage under the 
medicare program, and for other purposes; which was ordered to lie on 
the table; as follows:

       At the end of title IV, add the following:

     SEC. __. MEDPAC STUDY ON MEDICARE PAYMENTS AND EFFICIENCIES 
                   IN THE HEALTH CARE SYSTEM.

       Not later than 18 months after the date of enactment of 
     this Act, the Medicare Payment Advisory Commission 
     established under section 1805 of the Social Security Act (42 
     U.S.C. 1395b-6) shall provide Congress with recommendations 
     to recognize and reward, within payment methodologies for 
     physicians and hospitals established under the medicare 
     program under title XVIII of the Social Security Act, 
     efficiencies, and the lower utilization of services created 
     by the practice of medicine in historically efficient and 
     low-cost areas. Measures of efficiency recognized in 
     accordance with the preceding sentence shall include--
       (1) shorter hospital stays than the national average;
       (2) fewer physician visits than the national average;
       (3) fewer laboratory tests than the national average;
       (4) a greater utilization of hospice services than the 
     national average; and
       (5) the efficacy of disease management and preventive 
     health services.
                                 ______
                                 
  SA 942. Ms. CANTWELL submitted an amendment intended to be proposed 
by her to the bill S. 1, to amend title XVIII of the Social Security 
Act to make improvements in the medicare program, to provide 
prescription drug coverage under the medicare program, and for other 
purposes; which was ordered to lie on the table; as follows:

       On page 204, after line 22, insert the following:

     SEC. 133. PHARMACY BENEFIT MANAGERS TRANSPARENCY 
                   REQUIREMENTS.

       (a) Medicare.--Subpart 3 of part D of title XVIII of the 
     Social Security Act (as added by section 101) is amended by 
     adding at the end the following new section:


         ``pharmacy benefit managers transparency requirements

       ``Sec. 1860D-27. Notwithstanding any other provision of 
     law, an eligible entity offering a Medicare Prescription Drug 
     plan under this part or a MedicareAdvantage organization 
     offering a MedicareAdvantage plan under part C shall not 
     enter into a contract with any pharmacy benefit manager (in 
     this section referred to as a `PBM') to manage the 
     prescription drug coverage provided under such plan, or to 
     control the costs of such coverage, unless the PBM satisfies 
     the following requirements:
       ``(1) The PBM is not owned by a pharmaceutical 
     manufacturing company.
       ``(2) The PBM agrees to pass along any cost savings 
     negotiated with a pharmacy to the Medicare Prescription Drug 
     plan or the MedicareAdvantage plan.
       ``(3) The PBM agrees to make public on an annual basis the 
     percent of manufacturer's rebates received by the PBM that is 
     passed back to the Medicare Prescription Drug plan or the 
     MedicareAdvantage plan on a drug-by-drug basis.
       ``(4) The PBM agrees to provide, at least annually, the 
     Medicare Prescription Drug plan or the MedicareAdvantage plan 
     with all financial and utilization information requested by 
     the plan relating to the provision of benefits to eligible 
     beneficiaries through the PBM and all financial and 
     utilization information relating to services provided to the 
     plan. A PBM providing information under this paragraph may 
     designate that information as confidential. Information 
     designated as confidential by a PBM and provided to a plan 
     under this paragraph may not be disclosed to any person 
     without the consent of the PBM.
       ``(5) The PBM agrees to provide, at least annually, the 
     Medicare Prescription Drug plan or the MedicareAdvantage plan 
     with all financial terms and arrangements for remuneration of 
     any kind that apply between the PBM and any prescription drug 
     manufacturer or labeler, including formulary management and 
     drug-switch programs, educational support, claims processing 
     and

[[Page S8248]]

     pharmacy network fees that are charged from retail pharmacies 
     and data sales fees.
       ``(6) The PBM agrees to disclose the retail cost of a 
     prescription drug upon request by a consumer.''.
       (b) 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:

     ``SEC. 714. PHARMACY BENEFIT MANAGERS TRANSPARENCY 
                   REQUIREMENTS.

       ``The provisions of section 1860D-27 of the Social Security 
     Act shall apply to a group health plan, and a health 
     insurance issuer providing health insurance coverage in 
     connection with a group health plan, in the same manner as 
     such provisions apply to an eligible entity offering a 
     Medicare Prescription Drug plan under part D of title XVIII 
     of the Social Security Act or to a MedicareAdvantage 
     organization offering a MedicareAdvantage plan under part C 
     of title XVIII of that Act.''.
       (2) Clerical amendment.--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:

``Sec. 714. Pharmacy benefit managers transparency requirements.''.

       (3) Effective dates.--The amendments made by this 
     subsection shall apply with respect to plan years beginning 
     on or after the date of enactment of this Act.
       (c) Amendments to the Public Health Service Act Relating to 
     the Group Market.--
       (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. PHARMACY BENEFIT MANAGERS TRANSPARENCY 
                   REQUIREMENTS.

       ``The provisions of section 1860D-27 of the Social Security 
     Act shall apply to a group health plan and a health insurance 
     issuer providing health insurance coverage in connection with 
     a group health plan, in the same manner as such provisions 
     apply to an eligible entity offering a Medicare Prescription 
     Drug plan under part D of title XVIII of the Social Security 
     Act or to a MedicareAdvantage organization offering a 
     MedicareAdvantage plan under part C of title XVIII of that 
     Act.''.
       (2) Effective date.--The amendment made by this subsection 
     shall apply to group health plans and health insurance 
     issuers in connection with group health plans for plan years 
     beginning on or after the date of enactment of this Act.
       (d) Amendment to the Public Health Service Act Relating to 
     the Individual Market.--
       (1) In general.--The first subpart 3 of part B of title 
     XXVII of the Public Health Service Act (42 U.S.C. 300gg-51 et 
     seq.) is amended--
       (A) by redesignating such subpart as subpart 2; and
       (B) by adding at the end the following:

     ``SEC. 2753. PHARMACY BENEFIT MANAGERS TRANSPARENCY 
                   REQUIREMENTS.

       ``The provisions of section 1860D-27 of the Social Security 
     Act shall apply to health insurance coverage offered by a 
     health insurance issuer in the individual market in the same 
     manner as they apply to an eligible entity offering a 
     Medicare Prescription Drug plan under part D of title XVIII 
     of the Social Security Act or to a MedicareAdvantage 
     organization offering a MedicareAdvantage plan under part C 
     of title XVIII of that Act.''.
       (2) Effective date.--The amendment made by subsection 
     (c)(1)(B) shall apply with respect to health insurance 
     coverage offered, sold, issued, renewed, in effect, or 
     operated in the individual market on or after the date of 
     enactment of this Act.
       (e) Amendments to the Internal Revenue Code of 1986.--
       (1) In general.--Subchapter B of chapter 100 of the 
     Internal Revenue Code of 1986 is amended by inserting after 
     section 9812 the following:

     ``SEC. 9813. PHARMACY BENEFIT MANAGERS TRANSPARENCY 
                   REQUIREMENTS.

       ``The provisions of section 1860D-27 of the Social Security 
     Act shall apply to a group health plan in the same manner as 
     they apply to an eligible entity offering a Medicare 
     Prescription Drug plan under part D of title XVIII of the 
     Social Security Act or to a MedicareAdvantage organization 
     offering a MedicareAdvantage plan under part C of title XVIII 
     of that Act.''.
       (2) Clerical Amendment.--The table of contents for chapter 
     100 of such Code is amended by inserting after the item 
     relating to section 9812 the following

``Sec. 9813. Required coverage of young adults.''.

       (3) Effective date.--The amendments made by this subsection 
     shall apply with respect to plan years beginning on or after 
     the date of enactment of this Act.
                                 ______
                                 
  SA 943. Ms. CANTWELL submitted an amendment intended to be proposed 
by her to the bill S. 1, to amend title XVIII of the Social Security 
Act to make improvements in the medicare program, to provide 
prescription drug coverage under the medicare program, and for other 
purposes; which was ordered to lie on the table; as follows:

       On page 516, after line 22, add the following:

     SEC. __. INCENTIVE PAYMENT IN MEDICARE HEALTH PROFESSIONAL 
                   SHORTAGE AREAS DEMONSTRATION PROJECT.

       Title XVIII of the Social Security Act (42 U.S.C. 1395 et 
     seq.) is amended by adding at the end the following new 
     section:


  ``incentive payments in medicare health professional shortage areas 
                         demonstration project

       ``Sec. 1897. (a) Establishment.--
       ``(1) In general.--The Secretary shall establish a 
     demonstration project under which--
       ``(A) pursuant to paragraph (3), the Secretary designates 
     areas in a State selected under paragraph (5) as medicare 
     health professional shortage areas; and
       ``(B) an incentive payment is provided under part B to 
     primary care physicians for each physician's service (as 
     defined in section 1861(q)) that is furnished in a medicare 
     health professional shortage area to an individual enrolled 
     under such part.
       ``(2) Primary care physician defined.--For purposes of this 
     section, the term `primary care physician' has the meaning 
     given such term for purposes of designating health 
     professional shortage areas under section 332(a) of the 
     Public Health Service Act (42 U.S.C. 254e(a)).
       ``(3) Designation of areas.--The Secretary shall designate 
     an area in a State selected under paragraph (5) as a medicare 
     health professional shortage area if the Secretary 
     determines, using the methodology established under 
     subsection (b)(1)(B), that individuals enrolled under part B 
     and residing in the area have inadequate access to primary 
     care physicians.
       ``(4) Terms and conditions.--
       ``(A) Incentive payment in addition to payment otherwise 
     made.--
       ``(i) In general.--Subject to clause (ii), the incentive 
     payment made under the demonstration project for a 
     physician's service shall be in addition to the amount 
     otherwise made for the service under part B.
       ``(ii) No payments under the incentive payment program in a 
     demonstration state during operation of the demonstration 
     program.--Subject to subparagraph (D), notwithstanding 
     section 1833(m), during the operation of the demonstration 
     project in a State selected under paragraph (5), the 
     Secretary may not make any incentive payment to any physician 
     under such section for any service furnished in any part of 
     such State, regardless of--

       ``(I) whether the physician is eligible for bonus payments 
     under the demonstration program; and
       ``(II) where the service was furnished in the State.

       ``(B) Amount of incentive payment.--The amount of the 
     incentive payment for a physician's service furnished under 
     the demonstration project shall be an amount equal to 40 
     percent of the payment amount for the service under part B.
       ``(C) No effect on amount of coinsurance an individual is 
     required to pay.--The amount of any coinsurance that an 
     individual enrolled under part B is responsible for paying 
     with respect to a physicians' service furnished to the 
     individual shall be determined as if this section had not 
     been enacted.
       ``(D) No effect on payments to critical access hospitals.--
     The amount of payment for outpatient critical access services 
     of a critical access hospital under section 1834(g) shall be 
     determined as if this section had not been enacted.
       ``(5) Demonstration sites.--The Secretary shall conduct the 
     demonstration project in 5 States selected by the Secretary 
     as demonstration sites.
       ``(6) Automation of incentive payments.--
       ``(A) In general.--Under the demonstration project, 
     incentive payments under paragraph (1)(B) to a primary care 
     physician shall be made automatically to the physician rather 
     than the physician being responsible for determining when a 
     payment is required to be made under that paragraph.
       ``(B) Incentive payment based on zip codes.--In order to 
     comply with subparagraph (A), the Secretary shall establish 
     procedures in which the amount of payment otherwise made for 
     a physician's service is automatically increased by the 
     amount of the incentive payment under the demonstration 
     project if the service was furnished in any zip code that is 
     entirely or partially in a designated medicare health 
     professional shortage area in a State selected under 
     paragraph (5).
       ``(7) Duration.--The demonstration project shall be 
     conducted for a 3-year period. The period for establishing 
     the methodology under subsection (b) shall not be counted for 
     purposes determining such 3-year period.
       ``(b) Establishment of Methodology for Assisting Secretary 
     in Designating Medicare Health Professional Shortage Areas.--
       ``(1) In general.--The Secretary shall select 1 or more 
     Federal rural health research centers within the Health 
     Resources Services Administration to establish a methodology 
     to assist the Secretary in designating areas within the 
     States selected under subsection (a)(5) as medicare health 
     professional shortage areas pursuant to subsection (a)(3).
       ``(2) Rules for establishing methodology.--
       ``(A) In general.--The methodology established under 
     paragraph (1) shall address--

[[Page S8249]]

       ``(i) how to measure the percentage of the total population 
     in an area that consists of individuals enrolled under part 
     B; and
       ``(ii) the appropriate ratio of such individuals to primary 
     care physicians in an area in order to ensure that such 
     individuals have adequate access to services furnished by 
     such physicians.
       ``(B) Methodology may be similar to methodologies used 
     under the public health service act.--The methodology 
     established under paragraph (1) may be similar to 
     methodologies utilized by the Secretary for designating 
     areas, and population groups within areas, as health 
     professional shortage areas under section 332(a) of the 
     Public Health Service Act (42 U.S.C. 254e(a)).
       ``(C) Consultation.--The Federal rural health research 
     centers selected under paragraph (1) shall consult with the 
     State and local medical societies of the States selected 
     under subsection (a)(5) in establishing the methodology under 
     paragraph (1).
       ``(c) No Effect on Designation as a Health Professional 
     Shortage Area.--Except as provided in subsection 
     (a)(4)(A)(ii), the designation of an area as a medicare 
     health professional shortage area under subsection (a)(3) 
     shall have no effect on the designation of such area as a 
     health professional shortage area under section 332(a) of the 
     Public Health Service Act (42 U.S.C. 254e(a)).
       ``(d) Waiver Authority.--The Secretary may waive such 
     requirements of title XI and this title as may be necessary 
     for the purpose of carrying out the demonstration project.
       ``(e) Report.--
       ``(1) In general.--Not later than 6 months after the 
     completion of the demonstration project, the Secretary shall 
     submit to Congress a report on such project.
       ``(2) Contents.--The report submitted under paragraph (1) 
     shall contain--
       ``(A) an evaluation of whether the demonstration project 
     has had the effect of stabilizing, maintaining, or increasing 
     access of individuals enrolled under part B to physicians' 
     services furnished by primary care physicians, including 
     whether the amount of the incentive payment is adequate to 
     stabilize, maintain, or increase such access and if not, then 
     what amount will;
       ``(B) a comparison of the effectiveness of the 
     demonstration project in stabilizing, maintaining, or 
     increasing such access with the effectiveness of other 
     Federal, State, and local programs, such as the incentive 
     program under section 1833(m), that are designed to 
     stabilize, maintain, or increase such access;
       ``(C) recommendations for such legislation and 
     administrative actions as the Secretary considers 
     appropriate; and
       ``(D) any other items that the Secretary considers 
     appropriate.
       ``(f) Funding.--
       ``(1) Incentive payments.--The Secretary shall use funds in 
     the Federal Supplementary Medical Insurance Trust Fund under 
     section 1841 to make the incentive payments under this 
     section.
       ``(2) Establishment of methodology.--
       ``(A) In general.--There is authorized to be appropriated 
     $6,000,000 to establish the methodology under subsection 
     (b)(1).
       ``(B) Availability.--Any amounts appropriated pursuant to 
     subparagraph (A) shall remain available until expended.''.
                                 ______
                                 
  SA 944. Mr. ENZI (for Ms. Cantwell) proposed an amendment to 
amendment SA 932 proposed by Mr. Enzi (for himself, Mr. Reed, and Mr. 
Pryor) to the bill S. 1, to amend title XVIII of the Social Security 
Act to make improvements in the medicare program, to provide 
prescription drug coverage under the medicare program, and for other 
purposes; as follows:

       On page 2 of amendment SA#932 between lines 18 and 19 
     strike ``.'' and insert the following: ``with the auditor of 
     the Administrator's choice.''
                                 ______
                                 
  SA 945. Mr. GREGG (for himself, Mr. Schumer, Mr. McCain, Mr. Kennedy, 
Mr. Roberts, Mr. Edwards, Ms. Collins, Mr. Leahy, Mr. Johnson, Mr. 
Feingold, Mr. Harkin, Mr. Kohl, Mr. Smith, Ms. Stabenow, Mr. Miller, 
and Mr. Coleman) proposed an amendment to the bill S. 1, to amend title 
XVIII of the Social Security Act to make improvements in the medicare 
program, to provide prescription drug coverage under the medicare 
program, and for other purposes; as follows:

       At the end, add the following:

             TITLE __--ACCESS TO AFFORDABLE PHARMACEUTICALS

     SEC. __01. SHORT TITLE.

       This title may be cited as the ``Greater Access to 
     Affordable Pharmaceuticals Act''.

     SEC. __02. 30-MONTH STAY-OF-EFFECTIVENESS PERIOD.

       (a) Abbreviated New Drug Applications.--Section 505(j) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
     is amended--
       (1) in paragraph (2), by striking subparagraph (B) and 
     inserting the following:
       ``(B) Notice of opinion that patent is invalid or will not 
     be infringed.--
       ``(i) Agreement to give notice.--An applicant that makes a 
     certification described in subparagraph (A)(vii)(IV) shall 
     include in the application a statement that the applicant 
     will give notice as required by this subparagraph.
       ``(ii) Timing of notice.--An applicant that makes a 
     certification described in subparagraph (A)(vii)(IV) shall 
     give notice as required under this subparagraph--
       ``(I) if the certification is in the application, not later 
     than 20 days after the date of the postmark on the notice 
     with which the Secretary informs the applicant that the 
     application has been filed; or
       ``(II) if the certification is in an amendment or 
     supplement to the application, at the time at which the 
     applicant submits the amendment or supplement, regardless of 
     whether the applicant has already given notice with respect 
     to another such certification contained in the application or 
     in an amendment or supplement to the application.
       ``(iii) Recipients of notice.--An applicant required under 
     this subparagraph to give notice shall give notice to--
       ``(I) each owner of the patent that is the subject of the 
     certification (or a representative of the owner designated to 
     receive such a notice); and
       ``(II) the holder of the approved application under 
     subsection (b) for the drug that is claimed by the patent or 
     a use of which is claimed by the patent (or a representative 
     of the holder designated to receive such a notice).
       ``(iv) Contents of notice.--A notice required under this 
     subparagraph shall--
       ``(I) state that an application that contains data from 
     bioavailability or bioequivalence studies has been submitted 
     under this subsection for the drug with respect to which the 
     certification is made to obtain approval to engage in the 
     commercial manufacture, use, or sale of the drug before the 
     expiration of the patent referred to in the certification; 
     and
       ``(II) include a detailed statement of the factual and 
     legal basis of the opinion of the applicant that the patent 
     is invalid or will not be infringed.''; and
       (2) in paragraph (5)--
       (A) in subparagraph (B)--
       (i) by striking ``under the following'' and inserting ``by 
     applying the following to each certification made under 
     paragraph (2)(A)(vii)''; and
       (ii) in clause (iii)--

       (I) in the first sentence, by striking ``unless'' and all 
     that follows and inserting ``unless, before the expiration of 
     45 days after the date on which the notice described in 
     paragraph (2)(B) is received, an action is brought for 
     infringement of the patent that is the subject of the 
     certification and for which information was submitted to the 
     Secretary under subsection (b)(1) or (c)(2) before the date 
     on which the application (excluding an amendment or 
     supplement to the application), which the Secretary later 
     determines to be substantially complete, was submitted.''; 
     and
       (II) in the second sentence--

       (aa) by striking subclause (I) and inserting the following:
       ``(I) if before the expiration of such period the district 
     court decides that the patent is invalid or not infringed 
     (including any substantive determination that there is no 
     cause of action for patent infringement or invalidity), the 
     approval shall be made effective on--
       ``(aa) the date on which the court enters judgment 
     reflecting the decision; or
       ``(bb) the date of a settlement order or consent decree 
     signed and entered by the court stating that the patent that 
     is the subject of the certification is invalid or not 
     infringed;'';
       (bb) by striking subclause (II) and inserting the 
     following:
       ``(II) if before the expiration of such period the district 
     court decides that the patent has been infringed--
       ``(aa) if the judgment of the district court is appealed, 
     the approval shall be made effective on--

       ``(AA) the date on which the court of appeals decides that 
     the patent is invalid or not infringed (including any 
     substantive determination that there is no cause of action 
     for patent infringement or invalidity); or
       ``(BB) the date of a settlement order or consent decree 
     signed and entered by the court of appeals stating that the 
     patent that is the subject of the certification is invalid or 
     not infringed; or

       ``(bb) if the judgment of the district court is not 
     appealed or is affirmed, the approval shall be made effective 
     on the date specified by the district court in a court order 
     under section 271(e)(4)(A) of title 35, United States 
     Code;'';
       (cc) in subclause (III), by striking ``on the date of such 
     court decision.'' and inserting ``as provided in subclause 
     (I); or''; and
       (dd) by inserting after subclause (III) the following:
       ``(IV) if before the expiration of such period the court 
     grants a preliminary injunction prohibiting the applicant 
     from engaging in the commercial manufacture or sale of the 
     drug until the court decides the issues of patent validity 
     and infringement and if the court decides that such patent 
     has been infringed, the approval shall be made effective as 
     provided in subclause (II).'';
       (B) by redesignating subparagraphs (C) and (D) as 
     subparagraphs (E) and (F), respectively; and
       (C) by inserting after subparagraph (B) the following:
       ``(C) Civil action to obtain patent certainty.--

[[Page S8250]]

       ``(i) Declaratory judgment absent infringement action.--If 
     an owner of the patent or the holder of the approved 
     application under subsection (b) for the drug that is claimed 
     by the patent or a use of which is claimed by the patent does 
     not 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 given under paragraph 
     (2)(B) was received, the applicant may bring a civil action 
     against the owner or holder (but not against any owner or 
     holder that has brought such a civil action against that 
     applicant, unless that civil action was dismissed without 
     prejudice) for a declaratory judgment under section 2201 of 
     title 28, United States Code, that the patent is invalid or 
     will not be infringed by the drug for which the applicant 
     seeks approval.
       ``(ii) Counterclaim to infringement action.--

       ``(I) In general.--If an owner of the patent or the holder 
     of the approved application under subsection (b) for the drug 
     that is claimed by the patent or a use of which is claimed by 
     the patent brings a patent infringement action against the 
     applicant, the applicant may assert a counterclaim seeking an 
     order requiring the holder to correct or delete the patent 
     information submitted by the holder under subsection (b) or 
     (c) on the ground that the patent does not claim either--

       ``(aa) the drug for which the application was approved; or
       ``(bb) an approved method of using the drug.

       ``(II) No independent cause of action.--Subclause (I) does 
     not authorize the assertion of a claim described in subclause 
     (I) in any civil action or proceeding other than a 
     counterclaim described in subclause (I).

       ``(iii) No damages.--An applicant shall not be entitled to 
     damages in a civil action under subparagraph (i) or a 
     counterclaim under subparagraph (ii).''.
       (b) Applications Generally.--Section 505 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended--
       (1) in subsection (b), by striking paragraph (3) and 
     inserting the following:
       ``(3) Notice of opinion that patent is invalid or will not 
     be infringed.--
       ``(A) Agreement to give notice.--An applicant that makes a 
     certification described in paragraph (2)(A)(iv) shall include 
     in the application a statement that the applicant will give 
     notice as required by this paragraph.
       ``(B) Timing of notice.--An applicant that makes a 
     certification described in paragraph (2)(A)(iv) shall give 
     notice as required under this paragraph--
       ``(i) if the certification is in the application, not later 
     than 20 days after the date of the postmark on the notice 
     with which the Secretary informs the applicant that the 
     application has been filed; or
       ``(ii) if the certification is in an amendment or 
     supplement to the application, at the time at which the 
     applicant submits the amendment or supplement, regardless of 
     whether the applicant has already given notice with respect 
     to another such certification contained in the application or 
     in an amendment or supplement to the application.
       ``(C) Recipients of notice.--An applicant required under 
     this paragraph to give notice shall give notice to--
       ``(i) each owner of the patent that is the subject of the 
     certification (or a representative of the owner designated to 
     receive such a notice); and
       ``(ii) the holder of the approved application under this 
     subsection for the drug that is claimed by the patent or a 
     use of which is claimed by the patent (or a representative of 
     the holder designated to receive such a notice).
       ``(D) Contents of notice.--A notice required under this 
     paragraph shall--
       ``(i) state that an application that contains data from 
     bioavailability or bioequivalence studies has been submitted 
     under this subsection for the drug with respect to which the 
     certification is made to obtain approval to engage in the 
     commercial manufacture, use, or sale of the drug before the 
     expiration of the patent referred to in the certification; 
     and
       ``(ii) include a detailed statement of the factual and 
     legal basis of the opinion of the applicant that the patent 
     is invalid or will not be infringed.''; and
       (2) in subsection (c)(3)--
       (A) in the first sentence, by striking ``under the 
     following'' and inserting ``by applying the following to each 
     certification made under subsection (b)(2)(A)(iv)'';
       (B) in subparagraph (C)--
       (i) in the first sentence, by striking ``unless'' and all 
     that follows and inserting ``unless, before the expiration of 
     45 days after the date on which the notice described in 
     subsection (b)(3) is received, an action is brought for 
     infringement of the patent that is the subject of the 
     certification and for which information was submitted to the 
     Secretary under paragraph (2) or subsection (b)(1) before the 
     date on which the application (excluding an amendment or 
     supplement to the application) was submitted.'';
       (ii) in the second sentence--

       (I) by striking ``paragraph (3)(B)'' and inserting 
     ``subsection (b)(3)'';
       (II) by striking clause (i) and inserting the following:

       ``(i) if before the expiration of such period the district 
     court decides that the patent is invalid or not infringed 
     (including any substantive determination that there is no 
     cause of action for patent infringement or invalidity), the 
     approval shall be made effective on--
       ``(I) the date on which the court enters judgment 
     reflecting the decision; or
       ``(II) the date of a settlement order or consent decree 
     signed and entered by the court stating that the patent that 
     is the subject of the certification is invalid or not 
     infringed;'';

       (III) by striking clause (ii) and inserting the following:

       ``(ii) if before the expiration of such period the district 
     court decides that the patent has been infringed--
       ``(I) if the judgment of the district court is appealed, 
     the approval shall be made effective on--

       ``(aa) the date on which the court of appeals decides that 
     the patent is invalid or not infringed (including any 
     substantive determination that there is no cause of action 
     for patent infringement or invalidity); or
       ``(bb) the date of a settlement order or consent decree 
     signed and entered by the court of appeals stating that the 
     patent that is the subject of the certification is invalid or 
     not infringed; or

       ``(II) if the judgment of the district court is not 
     appealed or is affirmed, the approval shall be made effective 
     on the date specified by the district court in a court order 
     under section 271(e)(4)(A) of title 35, United States 
     Code;'';

       (IV) in clause (iii), by striking ``on the date of such 
     court decision.'' and inserting ``as provided in clause (i); 
     or''; and
       (V) by inserting after clause (iii), the following:

       ``(iv) if before the expiration of such period the court 
     grants a preliminary injunction prohibiting the applicant 
     from engaging in the commercial manufacture or sale of the 
     drug until the court decides the issues of patent validity 
     and infringement and if the court decides that such patent 
     has been infringed, the approval shall be made effective as 
     provided in clause (ii).''; and
       (iii) in the third sentence, by striking ``paragraph 
     (3)(B)'' and inserting ``subsection (b)(3)'';
       (C) by redesignating subparagraph (D) as subparagraph (E); 
     and
       (D) by inserting after subparagraph (C) the following:
       ``(D) Civil action to obtain patent certainty.--
       ``(i) Declaratory judgment absent infringement action.--If 
     an owner of the patent or the holder of the approved 
     application under subsection (b) for the drug that is claimed 
     by the patent or a use of which is claimed by the patent does 
     not 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 given under 
     subsection (b)(3) was received, the applicant may bring a 
     civil action against the owner or holder (but not against any 
     owner or holder that has brought such a civil action against 
     that applicant, unless that civil action was dismissed 
     without prejudice) for a declaratory judgment under section 
     2201 of title 28, United States Code, that the patent is 
     invalid or will not be infringed by the drug for which the 
     applicant seeks approval.
       ``(ii) Counterclaim to infringement action.--

       ``(I) In general.--If an owner of the patent or the holder 
     of the approved application under subsection (b) for the drug 
     that is claimed by the patent or a use of which is claimed by 
     the patent brings a patent infringement action against the 
     applicant, the applicant may assert a counterclaim seeking an 
     order requiring the holder to correct or delete the patent 
     information submitted by the holder under subsection (b) or 
     this subsection on the ground that the patent does not claim 
     either--

       ``(aa) the drug for which the application was approved; or
       ``(bb) an approved method of using the drug.

       ``(II) No independent cause of action.--Subclause (I) does 
     not authorize the assertion of a claim described in subclause 
     (I) in any civil action or proceeding other than a 
     counterclaim described in subclause (I).

       ``(iii) No damages.--An applicant shall not be entitled to 
     damages in a civil action under clause (i) or a counterclaim 
     under clause (ii).''.
       (c) Infringement Actions.--Section 271(e) of title 35, 
     United States Code, is amended by adding at the end the 
     following:
       ``(5) The filing of an application described in paragraph 
     (2) that includes a certification under subsection 
     (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), and the 
     failure of the owner of the patent to bring an action for 
     infringement of a patent that is the subject of the 
     certification before the expiration of 45 days after the date 
     on which the notice given under subsection (b)(3) or 
     (j)(2)(B) of that section is received, shall establish an 
     actual controversy between the applicant and the patent owner 
     sufficient to confer subject matter jurisdiction in the 
     courts of the United States in any action brought by the 
     applicant under section 2201 of title 28 for a declaratory 
     judgment that any patent that is the subject of the 
     certification is invalid or not infringed.''.
       (d) Applicability.--
       (1) In general.--Except as provided in paragraphs (2) and 
     (3), the amendments made by subsections (a), (b), and (c) 
     apply to any proceeding under section 505 of the Federal

[[Page S8251]]

     Food, Drug, and Cosmetic Act (21 U.S.C. 355) that is pending 
     on or after the date of enactment of this Act regardless of 
     the date on which the proceeding was commenced or is 
     commenced.
       (2) Notice of opinion that patent is invalid or will not be 
     infringed.--The amendments made by subsections (a)(1) and 
     (b)(1) apply with respect to any certification under 
     subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
     after the date of enactment of this Act in an application 
     filed under subsection (b)(2) or (j) of that section or in an 
     amendment or supplement to an application filed under 
     subsection (b)(2) or (j) of that section.
       (3) Effective date of approval.--The amendments made by 
     subsections (a)(2)(A)(ii)(I) and (b)(2)(B)(i) apply with 
     respect to any patent information submitted under subsection 
     (b)(1) or (c)(2) of section 505 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355) made after the date of 
     enactment of this Act.

     SEC. __03. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.

       (a) In General.--Section 505(j)(5) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) (as amended by 
     section __02) is amended--
       (1) in subparagraph (B), by striking clause (iv) and 
     inserting the following:
       ``(iv) 180-day exclusivity period.--
       ``(I) Definitions.--In this paragraph:
       ``(aa) 180-day exclusivity period.--The term `180-day 
     exclusivity period' means the 180-day period ending on the 
     day before the date on which an application submitted by an 
     applicant other than a first applicant could become effective 
     under this clause.
       ``(bb) First applicant.--The term `first applicant' means 
     an applicant that, on the first day on which a substantially 
     complete application containing a certification described in 
     paragraph (2)(A)(vii)(IV) is submitted for approval of a 
     drug, submits a substantially complete application containing 
     a certification described in paragraph (2)(A)(vii)(IV) for 
     the drug.
       ``(cc) Substantially complete application.--As used in this 
     subsection, the term `substantially complete application' 
     means an application under this subsection that on its face 
     is sufficiently complete to permit a substantive review and 
     contains all the information required by paragraph (2)(A).
       ``(dd) Tentative approval.--

       ``(AA) In general.--The term `tentative approval' means 
     notification to an applicant by the Secretary that an 
     application under this subsection meets the requirements of 
     paragraph (2)(A), but cannot receive effective approval 
     because the application does not meet the requirements of 
     this subparagraph, there is a period of exclusivity for the 
     listed drug under subparagraph (E) or section 505A, or there 
     is a 7-year period of exclusivity for the listed drug under 
     section 527.
       ``(BB) Limitation.--A drug that is granted tentative 
     approval by the Secretary is not an approved drug and shall 
     not have an effective approval until the Secretary issues an 
     approval after any necessary additional review of the 
     application.

       ``(II) Effectiveness of application.--Subject to 
     subparagraph (D), if the application contains a certification 
     described in paragraph (2)(A)(vii)(IV) and is for a drug for 
     which a first applicant has submitted an application 
     containing such a certification, the application shall be 
     made effective on the date that is 180 days after the date of 
     the first commercial marketing of the drug (including the 
     commercial marketing of the listed drug) by any first 
     applicant.''; and
       (2) by inserting after subparagraph (C) the following:
       ``(D) Forfeiture of 180-day exclusivity period.--
       ``(i) Definition of forfeiture event.--In this 
     subparagraph, the term `forfeiture event', with respect to an 
     application under this subsection, means the occurrence of 
     any of the following:

       ``(I) Failure to market.--The first applicant fails to 
     market the drug by the later of--

       ``(aa) the earlier of the date that is--
       ``(AA) 75 days after the date on which the approval of the 
     application of the first applicant is made effective under 
     subparagraph (B)(iii); or
       ``(BB) 30 months after the date of submission of the 
     application of the first applicant; or
       ``(bb) with respect to the first applicant or any other 
     applicant (which other applicant has received tentative 
     approval), the date that is 75 days after the date as of 
     which, as to each of the patents with respect to which the 
     first applicant submitted a certification qualifying the 
     first applicant for the 180-day exclusivity period under 
     subparagraph (B)(iv), at least 1 of the following has 
     occurred:
       ``(AA) In an infringement action brought against that 
     applicant with respect to the patent or in a declaratory 
     judgment action brought by that applicant with respect to the 
     patent, a court enters a final decision from which no appeal 
     (other than a petition to the Supreme Court for a writ of 
     certiorari) has been or can be taken that the patent is 
     invalid or not infringed.
       ``(BB) In an infringement action or a declaratory judgment 
     action described in subitem (AA), a court signs a settlement 
     order or consent decree that enters a final judgment that 
     includes a finding that the patent is invalid or not 
     infringed.
       ``(CC) The patent expires.
       ``(DD) The patent is withdrawn by the holder of the 
     application approved under subsection (b).

       ``(II) Withdrawal of application.--The first applicant 
     withdraws the application or the Secretary considers the 
     application to have been withdrawn as a result of a 
     determination by the Secretary that the application does not 
     meet the requirements for approval under paragraph (4).
       ``(III) Amendment of certification.--The first applicant 
     amends or withdraws the certification for all of the patents 
     with respect to which that applicant submitted a 
     certification qualifying the applicant for the 180-day 
     exclusivity period.
       ``(IV) Failure to obtain tentative approval.--The first 
     applicant fails to obtain tentative approval of the 
     application within 30 months after the date on which the 
     application is filed, unless the failure is caused by a 
     change in or a review of the requirements for approval of the 
     application imposed after the date on which the application 
     is filed.
       ``(V) Agreement with another applicant, the listed drug 
     application holder, or a patent owner.--The first applicant 
     enters into an agreement with another applicant under this 
     subsection for the drug, the holder of the application for 
     the listed drug, or an owner of the patent that is the 
     subject of the certification under paragraph (2)(A)(vii)(IV), 
     the Federal Trade Commission or the Attorney General files a 
     complaint, and there is a final decision of the Federal Trade 
     Commission or the court with regard to the complaint from 
     which no appeal (other than a petition to the Supreme Court 
     for a writ of certiorari) has been or can be taken that the 
     agreement has violated the antitrust laws (as defined in 
     section 1 of the Clayton Act (15 U.S.C. 12), except that the 
     term includes section 5 of the Federal Trade Commission Act 
     (15 U.S.C. 45) to the extent that that section applies to 
     unfair methods of competition).
       ``(VI) Expiration of all patents.--All of the patents as to 
     which the applicant submitted a certification qualifying it 
     for the 180-day exclusivity period have expired.

       ``(ii) Forfeiture.--The 180-day exclusivity period 
     described in subparagraph (B)(iv) shall be forfeited by a 
     first applicant if a forfeiture event occurs with respect to 
     that first applicant.
       ``(iii) Subsequent applicant.--If all first applicants 
     forfeit the 180-day exclusivity period under clause (ii)--

       ``(I) approval of any application containing a 
     certification described in paragraph (2)(A)(vii)(IV) shall be 
     made effective in accordance with subparagraph (B)(iii); and
       ``(II) no applicant shall be eligible for a 180-day 
     exclusivity period.''.

       (b) Effective Date.--
       (1) In general.--Except as provided in paragraph (2), the 
     amendment made by subsection (a) shall be effective only with 
     respect to an application filed under section 505(j) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) after 
     the date of enactment of this Act for a listed drug for which 
     no certification under section 505(j)(2)(A)(vii)(IV) of that 
     Act was made before the date of enactment of this Act.
       (2) Collusive agreements.--If a forfeiture event described 
     in section 505(j)(5)(D)(i)(V) of that Act occurs in the case 
     of an applicant, the applicant shall forfeit the 180-day 
     period under section 505(j)(5)(B)(iv) of that Act without 
     regard to when the first certification under section 
     505(j)(2)(A)(vii)(IV) of that Act for the listed drug was 
     made.
       (3) Decision of a court when the 180-day exclusivity period 
     has not been triggered.--With respect to an application filed 
     before, on, or after the date of enactment of this Act for a 
     listed drug for which a certification under section 
     505(j)(2)(A)(vii)(IV) of that Act was made before the date of 
     enactment of this Act and for which neither of the events 
     described in subclause (I) or (II) of section 
     505(j)(5)(B)(iv) of that Act (as in effect on the day before 
     the date of enactment of this Act) has occurred on or before 
     the date of enactment of this Act, the term ``decision of a 
     court'' as used in clause (iv) of section 505(j)(5)(B) of 
     that Act means a final decision of a court from which no 
     appeal (other than a petition to the Supreme Court for a writ 
     of certiorari) has been or can be taken.

     SEC. __04. BIOAVAILABILITY AND BIOEQUIVALENCE.

       (a) In General.--Section 505(j)(8) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355(j)(8)) is amended--
       (1) by striking subparagraph (A) and inserting the 
     following:
       ``(A)(i) The term `bioavailability' means the rate and 
     extent to which the active ingredient or therapeutic 
     ingredient is absorbed from a drug and becomes available at 
     the site of drug action.
       ``(ii) For a drug that is not intended to be absorbed into 
     the bloodstream, the Secretary may assess bioavailability by 
     scientifically valid measurements intended to reflect the 
     rate and extent to which the active ingredient or therapeutic 
     ingredient becomes available at the site of drug action.''; 
     and
       (2) by adding at the end the following:
       ``(C) For a drug that is not intended to be absorbed into 
     the bloodstream, the Secretary may establish alternative, 
     scientifically valid methods to show bioequivalence if the 
     alternative methods are expected to detect a significant 
     difference between the drug and the listed drug in safety and 
     therapeutic effect.''.
       (b) Effect of Amendment.--The amendment made by subsection 
     (a) does not alter

[[Page S8252]]

     the standards for approval of drugs under section 505(j) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).

     SEC. __05. REMEDIES FOR INFRINGEMENT.

       Section 287 of title 35, United States Code, is amended by 
     adding at the end the following:
       ``(d) Consideration.--In making a determination with 
     respect to remedy brought for infringement of a patent that 
     claims a drug or a method or using a drug, the court shall 
     consider whether information on the patent was filed as 
     required under 21 U.S.C. 355 (b) or (c), and, if such 
     information was required to be filed but was not, the court 
     may refuse to award treble damages under section 284.''.

     SEC. __06. CONFORMING AMENDMENTS.

       Section 505A of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355a) is amended--
       (1) in subsections (b)(1)(A)(i) and (c)(1)(A)(i), by 
     striking ``(j)(5)(D)(ii)'' each place it appears and 
     inserting ``(j)(5)(F)(ii)'';
       (2) in subsections (b)(1)(A)(ii) and (c)(1)(A)(ii), by 
     striking ``(j)(5)(D)'' each place it appears and inserting 
     ``(j)(5)(F)''; and
       (3) in subsections (e) and (l), by striking 
     ``505(j)(5)(D)'' each place it appears and inserting 
     ``505(j)(5)(F)''.
                                 ______
                                 
  SA 946. Mr. DORGAN (for himself, Ms. Stabenow, Mr. Jeffords, Ms. 
Snowe, Mr. Johnson, Mr. Leahy, Mrs. Boxer, Mr. Pryor, Mr. Feingold, and 
Ms. Collins) proposed an amendment to the bill S. 1, to amend title 
XVIII of the Social Security Act to make improvements in the medicare 
program, to provide prescription drug coverage under the medicare 
program, and for other purposes; as follows:

       At the end, add the following:

              TITLE __--IMPORTATION OF PRESCRIPTION DRUGS

     SEC. __01. IMPORTATION OF PRESCRIPTION DRUGS.

       (a) In General.--Chapter VIII of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381 et seq.) is amended by 
     striking section 804 and inserting the following:

     ``SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS.

       ``(a) Definitions.--In this section:
       ``(1) Importer.--The term `importer' means a pharmacist or 
     wholesaler.
       ``(2) Pharmacist.--The term `pharmacist' means a person 
     licensed by a State to practice pharmacy, including the 
     dispensing and selling of prescription drugs.
       ``(3) Prescription drug.--The term `prescription drug' 
     means a drug subject to section 503(b), other than--
       ``(A) a controlled substance (as defined in section 102 of 
     the Controlled Substances Act (21 U.S.C. 802));
       ``(B) a biological product (as defined in section 351 of 
     the Public Health Service Act (42 U.S.C. 262));
       ``(C) an infused drug (including a peritoneal dialysis 
     solution);
       ``(D) an intravenously injected drug; or
       ``(E) a drug that is inhaled during surgery.
       ``(4) Qualifying laboratory.--The term `qualifying 
     laboratory' means a laboratory in the United States that has 
     been approved by the Secretary for the purposes of this 
     section.
       ``(5) Wholesaler.--
       ``(A) In general.--The term `wholesaler' means a person 
     licensed as a wholesaler or distributor of prescription drugs 
     in the United States under section 503(e)(2)(A).
       ``(B) Exclusion.--The term `wholesaler' does not include a 
     person authorized to import drugs under section 801(d)(1).
       ``(b) Regulations.--The Secretary, after consultation with 
     the United States Trade Representative and the Commissioner 
     of Customs, shall promulgate regulations permitting 
     pharmacists and wholesalers to import prescription drugs from 
     Canada into the United States.
       ``(c) Limitation.--The regulations under subsection (b) 
     shall--
       ``(1) require that safeguards be in place to ensure that 
     each prescription drug imported under the regulations 
     complies with section 505 (including with respect to being 
     safe and effective for the intended use of the prescription 
     drug), with sections 501 and 502, and with other applicable 
     requirements of this Act;
       ``(2) require that an importer of a prescription drug under 
     the regulations comply with subsections (d)(1) and (e); and
       ``(3) contain any additional provisions determined by the 
     Secretary to be appropriate as a safeguard to protect the 
     public health or as a means to facilitate the importation of 
     prescription drugs.
       ``(d) Information and Records.--
       ``(1) In general.--The regulations under subsection (b) 
     shall require an importer of a prescription drug under 
     subsection (b) to submit to the Secretary the following 
     information and documentation:
       ``(A) The name and quantity of the active ingredient of the 
     prescription drug.
       ``(B) A description of the dosage form of the prescription 
     drug.
       ``(C) The date on which the prescription drug is shipped.
       ``(D) The quantity of the prescription drug that is 
     shipped.
       ``(E) The point of origin and destination of the 
     prescription drug.
       ``(F) The price paid by the importer for the prescription 
     drug.
       ``(G) Documentation from the foreign seller specifying--
       ``(i) the original source of the prescription drug; and
       ``(ii) the quantity of each lot of the prescription drug 
     originally received by the seller from that source.
       ``(H) The lot or control number assigned to the 
     prescription drug by the manufacturer of the prescription 
     drug.
       ``(I) The name, address, telephone number, and professional 
     license number (if any) of the importer.
       ``(J)(i) In the case of a prescription drug that is shipped 
     directly from the first foreign recipient of the prescription 
     drug from the manufacturer:
       ``(I) Documentation demonstrating that the prescription 
     drug was received by the recipient from the manufacturer and 
     subsequently shipped by the first foreign recipient to the 
     importer.
       ``(II) Documentation of the quantity of each lot of the 
     prescription drug received by the first foreign recipient 
     demonstrating that the quantity being imported into the 
     United States is not more than the quantity that was received 
     by the first foreign recipient.
       ``(III)(aa) In the case of an initial imported shipment, 
     documentation demonstrating that each batch of the 
     prescription drug in the shipment was statistically sampled 
     and tested for authenticity and degradation.
       ``(bb) In the case of any subsequent shipment, 
     documentation demonstrating that a statistically valid sample 
     of the shipment was tested for authenticity and degradation.
       ``(ii) In the case of a prescription drug that is not 
     shipped directly from the first foreign recipient of the 
     prescription drug from the manufacturer, documentation 
     demonstrating that each batch in each shipment offered for 
     importation into the United States was statistically sampled 
     and tested for authenticity and degradation.
       ``(K) Certification from the importer or manufacturer of 
     the prescription drug that the prescription drug--
       ``(i) is approved for marketing in the United States; and
       ``(ii) meets all labeling requirements under this Act.
       ``(L) Laboratory records, including complete data derived 
     from all tests necessary to ensure that the prescription drug 
     is in compliance with established specifications and 
     standards.
       ``(M) Documentation demonstrating that the testing required 
     by subparagraphs (J) and (L) was conducted at a qualifying 
     laboratory.
       ``(N) Any other information that the Secretary determines 
     is necessary to ensure the protection of the public health.
       ``(2) Maintenance by the secretary.--The Secretary shall 
     maintain information and documentation submitted under 
     paragraph (1) for such period of time as the Secretary 
     determines to be necessary.
       ``(e) Testing.--The regulations under subsection (b) shall 
     require--
       ``(1) that testing described in subparagraphs (J) and (L) 
     of subsection (d)(1) be conducted by the importer or by the 
     manufacturer of the prescription drug at a qualified 
     laboratory;
       ``(2) if the tests are conducted by the importer--
       ``(A) that information needed to--
       ``(i) authenticate the prescription drug being tested; and
       ``(ii) confirm that the labeling of the prescription drug 
     complies with labeling requirements under this Act;

     be supplied by the manufacturer of the prescription drug to 
     the pharmacist or wholesaler; and
       ``(B) that the information supplied under subparagraph (A) 
     be kept in strict confidence and used only for purposes of 
     testing or otherwise complying with this Act; and
       ``(3) may include such additional provisions as the 
     Secretary determines to be appropriate to provide for the 
     protection of trade secrets and commercial or financial 
     information that is privileged or confidential.
       ``(f) Registration of Foreign Sellers.--Any establishment 
     within Canada engaged in the distribution of a prescription 
     drug that is imported or offered for importation into the 
     United States shall register with the Secretary the name and 
     place of business of the establishment.
       ``(g) Suspension of Importation.--The Secretary shall 
     require that importations of a specific prescription drug or 
     importations by a specific importer under subsection (b) be 
     immediately suspended on discovery of a pattern of 
     importation of that specific prescription drug or by that 
     specific importer of drugs that are counterfeit or in 
     violation of any requirement under this section, until an 
     investigation is completed and the Secretary determines that 
     the public is adequately protected from counterfeit and 
     violative prescription drugs being imported under subsection 
     (b).
       ``(h) Approved Labeling.--The manufacturer of a 
     prescription drug shall provide an importer written 
     authorization for the importer to use, at no cost, the 
     approved labeling for the prescription drug.
       ``(i) Prohibition of Discrimination.--
       ``(1) In general.--It shall be unlawful for a manufacturer 
     of a prescription drug to discriminate against, or cause any 
     other person to discriminate against, a pharmacist or 
     wholesaler that purchases or offers to purchase a 
     prescription drug from the manufacturer or from any person 
     that distributes a

[[Page S8253]]

     prescription drug manufactured by the drug manufacturer.
       ``(2) Discrimination.--For the purposes of paragraph (1), a 
     manufacturer of a prescription drug shall be considered to 
     discriminate against a pharmacist or wholesaler if the 
     manufacturer enters into a contract for sale of a 
     prescription drug, places a limit on supply, or employs any 
     other measure, that has the effect of--
       ``(A) providing pharmacists or wholesalers access to 
     prescription drugs on terms or conditions that are less 
     favorable than the terms or conditions provided to a foreign 
     purchaser (other than a charitable or humanitarian 
     organization) of the prescription drug; or
       ``(B) restricting the access of pharmacists or wholesalers 
     to a prescription drug that is permitted to be imported into 
     the United States under this section.
       ``(j) Charitable Contributions.--Notwithstanding any other 
     provision of this section, section 801(d)(1) continues to 
     apply to a prescription drug that is donated or otherwise 
     supplied at no charge by the manufacturer of the drug to a 
     charitable or humanitarian organization (including the United 
     Nations and affiliates) or to a government of a foreign 
     country.
       ``(k) Waiver Authority for Importation by Individuals.--
       ``(1) Declarations.--Congress declares that in the 
     enforcement against individuals of the prohibition of 
     importation of prescription drugs and devices, the Secretary 
     should--
       ``(A) focus enforcement on cases in which the importation 
     by an individual poses a significant threat to public health; 
     and
       ``(B) exercise discretion to permit individuals to make 
     such importations in circumstances in which--
       ``(i) the importation is clearly for personal use; and
       ``(ii) the prescription drug or device imported does not 
     appear to present an unreasonable risk to the individual.
       ``(2) Waiver authority.--
       ``(A) In general.--The Secretary may grant to individuals, 
     by regulation or on a case-by-case basis, a waiver of the 
     prohibition of importation of a prescription drug or device 
     or class of prescription drugs or devices, under such 
     conditions as the Secretary determines to be appropriate.
       ``(B) Guidance on case-by-case waivers.--The Secretary 
     shall publish, and update as necessary, guidance that 
     accurately describes circumstances in which the Secretary 
     will consistently grant waivers on a case-by-case basis under 
     subparagraph (A), so that individuals may know with the 
     greatest practicable degree of certainty whether a particular 
     importation for personal use will be permitted.
       ``(3) Drugs imported from canada.--In particular, the 
     Secretary shall by regulation grant individuals a waiver to 
     permit individuals to import into the United States a 
     prescription drug that--
       ``(A) is imported from a licensed pharmacy for personal use 
     by an individual, not for resale, in quantities that do not 
     exceed a 90-day supply;
       ``(B) is accompanied by a copy of a valid prescription;
       ``(C) is imported from Canada, from a seller registered 
     with the Secretary;
       ``(D) is a prescription drug approved by the Secretary 
     under chapter V;
       ``(E) is in the form of a final finished dosage that was 
     manufactured in an establishment registered under section 
     510; and
       ``(F) is imported under such other conditions as the 
     Secretary determines to be necessary to ensure public safety.
       ``(l) Studies; Reports.--
       ``(1) By the institute of medicine of the national academy 
     of sciences.--
       ``(A) Study.--
       ``(i) In general.--The Secretary shall request that the 
     Institute of Medicine of the National Academy of Sciences 
     conduct a study of--

       ``(I) importations of prescription drugs made under the 
     regulations under subsection (b); and
       ``(II) information and documentation submitted under 
     subsection (d).

       ``(ii) Requirements.--In conducting the study, the 
     Institute of Medicine shall--

       ``(I) evaluate the compliance of importers with the 
     regulations under subsection (b);
       ``(II) compare the number of shipments under the 
     regulations under subsection (b) during the study period that 
     are determined to be counterfeit, misbranded, or adulterated, 
     and compare that number with the number of shipments made 
     during the study period within the United States that are 
     determined to be counterfeit, misbranded, or adulterated; and
       ``(III) consult with the Secretary, the United States Trade 
     Representative, and the Commissioner of Patents and 
     Trademarks to evaluate the effect of importations under the 
     regulations under subsection (b) on trade and patent rights 
     under Federal law.

       ``(B) Report.--Not later than 2 years after the effective 
     date of the regulations under subsection (b), the Institute 
     of Medicine shall submit to Congress a report describing the 
     findings of the study under subparagraph (A).
       ``(2) By the comptroller general.--
       ``(A) Study.--The Comptroller General of the United States 
     shall conduct a study to determine the effect of this section 
     on the price of prescription drugs sold to consumers at 
     retail.
       ``(B) Report.--Not later than 18 months after the effective 
     date of the regulations under subsection (b), the Comptroller 
     General of the United States shall submit to Congress a 
     report describing the findings of the study under 
     subparagraph (A).
       ``(m) Construction.--Nothing in this section limits the 
     authority of the Secretary relating to the importation of 
     prescription drugs, other than with respect to section 
     801(d)(1) as provided in this section.
       ``(n) Effectiveness of Section.--
       ``(1) In general.--If, after the date that is 1 year after 
     the effective date of the regulations under subsection (b) 
     and before the date that is 18 months after the effective 
     date, the Secretary submits to Congress a certification that, 
     in the opinion of the Secretary, based on substantial 
     evidence obtained after the effective date, the benefits of 
     implementation of this section do not outweigh any detriment 
     of implementation of this section, this section shall cease 
     to be effective as of the date that is 30 days after the date 
     on which the Secretary submits the certification.
       ``(2) Procedure.--The Secretary shall not submit a 
     certification under paragraph (1) unless, after a hearing on 
     the record under sections 556 and 557 of title 5, United 
     States Code, the Secretary--
       ``(A)(i) determines that it is more likely than not that 
     implementation of this section would result in an increase in 
     the risk to the public health and safety;
       ``(ii) identifies specifically, in qualitative and 
     quantitative terms, the nature of the increased risk;
       ``(iii) identifies specifically the causes of the increased 
     risk; and
       ``(iv)(I) considers whether any measures can be taken to 
     avoid, reduce, or mitigate the increased risk; and
       ``(II) if the Secretary determines that any measures 
     described in subclause (I) would require additional statutory 
     authority, submits to Congress a report describing the 
     legislation that would be required;
       ``(B) identifies specifically, in qualitative and 
     quantitative terms, the benefits that would result from 
     implementation of this section (including the benefit of 
     reductions in the cost of covered products to consumers in 
     the United States, allowing consumers to procure needed 
     medication that consumers might not otherwise be able to 
     procure without foregoing other necessities of life); and
       ``(C)(i) compares in specific terms the detriment 
     identified under subparagraph (A) with the benefits 
     identified under subparagraph (B); and
       ``(ii) determines that the benefits do not outweigh the 
     detriment.
       ``(o) Authorization of Appropriations.--There are 
     authorized to be appropriated such sums as are necessary to 
     carry out this section.''.
       (b) Conforming Amendments.--The Federal Food, Drug, and 
     Cosmetic Act is amended--
       (1) in section 301(aa) (21 U.S.C. 331(aa)), by striking 
     ``covered product in violation of section 804'' and inserting 
     ``prescription drug in violation of section 804''; and
       (2) in section 303(a)(6) (21 U.S.C. 333(a)(6), by striking 
     ``covered product pursuant to section 804(a)'' and inserting 
     ``prescription drug under section 804(b)''.
                                 ______
                                 
  SA 947. Mr. FRIST (for Mr. Cochran (for himself, Mr. Frist, Mr. 
Breaux, and Mr. Santorum)) proposed an amendment to amend SA 946 
proposed by Mr. Dorgan (for himself, Ms. Stabenow, Mr. Jeffords, Ms. 
Snowe, Mr. Johnson, Mr. Leahy, Mrs. Boxer, Mr. Pryor, Mr. Feingold, and 
Ms. Collins) to the bill S. 1, to amend title XVIII of the Social 
Security Act to make improvements in the medicare program, to provide 
prescription drug coverage under the medicare program, and for other 
purposes; as follows:

       At the appropriate place, insert the following:
       ``(  ) Conditions.--this section shall become effective 
     only if the Secretary of Health and Human Services certifies 
     to the Congress that the implementation of this section 
     will--
       ``(A) pose no additional risk to the public's health and 
     safety, and
       ''(B) result in a significant reduction in the cost of 
     covered products to the American consumer.''.
                                 ______
                                 
  SA 948. Mr. GRAHAM of South Carolina submitted an amendment intended 
to be proposed by him to the bill S. 1, to amend title XVIII of the 
Social Security Act to make improvements in the medicare program, to 
provide prescription drug coverage under the medicare program, and for 
other purposes; which was ordered to lie on the table; as follows:

       At the appropriate place in title II, insert the following:

     Subtitle __--National Bipartisan Commission on Medicare Reform

     SEC. __01. MEDICAREADVANTAGE GOAL; ESTABLISHMENT OF 
                   COMMISSION.

       (a) Enrollment Goal.--It is the goal of this title that, 
     not later than January 1, 2010, at least 15 percent of 
     individuals entitled to, or enrolled for, benefits under part 
     A of title XVIII of the Social Security Act and enrolled 
     under part B of such title should be enrolled in a 
     MedicareAdvantage plan, as determined by the Center for 
     Medicare Choices.

[[Page S8254]]

       (b) Failure to Achieve Goal.--If the goal described in 
     subsection (a) is not met by January 1, 2012, as determined 
     by the Center for Medicare Choices, there shall be 
     established a commission as described in section 2.

      SEC. __02 NATIONAL BIPARTISAN COMMISSION ON MEDICARE REFORM.

       (a) Establishment.--Upon a determination under section 
     __01(b) that the enrollment goal has not been met, there 
     shall be established a commission to be known as the National 
     Bipartisan Commission on Medicare Reform (in this section 
     referred to as the ``Commission'').
       (b) Duties of the Commission.--The Commission shall--
       (1) review and analyze the long-term financial condition of 
     the medicare program under title XVIII of the Social Security 
     Act (42 U.S.C. 1395 et seq.);
       (2) identify problems that threaten the financial integrity 
     of the Federal Hospital Insurance Trust Fund and the Federal 
     Supplementary Medical Insurance Trust Fund established under 
     sections 1817 and 1841 of such Act (42 U.S.C. 1395i and 
     1395t), including--
       (A) the financial impact on the medicare program of the 
     significant increase in the number of medicare eligible 
     individuals; and
       (B) the ability of the Federal Government to sustain the 
     program into the future;
       (3) analyze potential solutions to the problems identified 
     under paragraph (2) that will ensure both the financial 
     integrity of the medicare program and the provision of 
     appropriate benefits under such program, including methods 
     used by other nations to respond to comparable demographic 
     patterns in eligibility for health care benefits for elderly 
     and disabled individuals and trends in employment-related 
     health care for retirees;
       (4) make recommendations to restore the solvency of the 
     Federal Hospital Insurance Trust Fund and the financial 
     integrity of the Federal Supplementary Medical Insurance 
     Trust Fund;
       (5) make recommendations for establishing the appropriate 
     financial structure of the medicare program as a whole;
       (6) make recommendations for establishing the appropriate 
     balance of benefits covered under, and beneficiary 
     contributions to, the medicare program;
       (7) make recommendations for the time periods during which 
     the recommendations described in paragraphs (4), (5) and (6) 
     should be implemented;
       (8) make recommendations on the impact of chronic disease 
     and disability trends on future costs and quality of services 
     under the current benefit, financing, and delivery system 
     structure of the medicare program;
       (9) make recommendations regarding a comprehensive approach 
     to preserve the medicare program, including ways to increase 
     the effectiveness of the MedicareAdvantage program and to 
     increase MedicareAdvantage enrollment rates; and
       (10) review and analyze such other matters as the 
     Commission determines appropriate.
       (c) Membership.--
       (1) Number and appointment.--The Commission shall be 
     composed of 17 members, of whom--
       (A) four shall be appointed by the President;
       (B) six shall be appointed by the Majority Leader of the 
     Senate, in consultation with the Minority Leader of the 
     Senate, of whom not more than 4 shall be of the same 
     political party;
       (C) six shall be appointed by the Speaker of the House of 
     Representatives, in consultation with the Minority Leader of 
     the House of Representatives, of whom not more than 4 shall 
     be of the same political party; and
       (D) one, who shall serve as Chairperson of the Commission, 
     shall be appointed jointly by the President, Majority Leader 
     of the Senate, and the Speaker of the House of 
     Representatives.
       (2) Deadline for appointment.--Members of the Commission 
     shall be appointed by not later than April 1, 2012.
       (3) Terms of appointment.--The term of any member appointed 
     under paragraph (1) shall be for the life of the Commission.
       (4) Meetings.--The Commission shall meet at the call of the 
     Chairperson or a majority of its members.
       (5) Quorum.--A quorum for purposes of conducting the 
     business of the Commission shall consist of 8 members of the 
     Commission, except that 4 members may conduct a hearing under 
     subsection (e).
       (6) Vacancies.--A vacancy in the membership of the 
     Commission shall be filled, not later than 30 days after the 
     Commission is given notice of the vacancy, in the same manner 
     in which the original appointment was made. Such a vacancy 
     shall not affect the power of the remaining members to carry 
     out the duties of the Commission.
       (7) Compensation.--Members of the Commission shall receive 
     no additional pay, allowances, or benefits by reason of their 
     service on the Commission.
       (8) Expenses.--Each member of the Commission shall receive 
     travel expenses and per diem in lieu of subsistence in 
     accordance with sections 5702 and 5703 of title 5, United 
     States Code.
       (d) Staff and Support Services.--
       (1) Executive director.--
       (A) Appointment.--The Chairperson shall appoint an 
     executive director of the Commission.
       (B) Compensation.--The executive director shall be paid the 
     rate of basic pay for level V of the Executive Schedule under 
     title 5, United States Code.
       (2) Staff.--With the approval of the Commission, the 
     executive director may appoint such personnel as the 
     executive director considers appropriate.
       (3) Applicability of civil service laws.--The staff of the 
     Commission shall be appointed without regard to the 
     provisions of title 5, United States Code, governing 
     appointments in the competitive service, and shall be paid 
     without regard to the provisions of chapter 51 and subchapter 
     III of chapter 53 of such title (relating to classification 
     and General Schedule pay rates).
       (4) Experts and consultants.--With the approval of the 
     Commission, the executive director may procure temporary and 
     intermittent services under section 3109(b) of title 5, 
     United States Code.
       (5) Physical facilities.--The Administrator of the General 
     Services Administration shall locate suitable office space 
     for the operation of the Commission. The facilities shall 
     serve as the headquarters of the Commission and shall include 
     all necessary equipment and incidentals required for the 
     proper functioning of the Commission.
       (e) Powers of Commission.--
       (1) Hearings and other activities.--The Commission may hold 
     such hearings and undertake such other activities as the 
     Commission determines to be necessary to carry out its duties 
     under this section.
       (2) Studies by gao.--Upon the request of the Commission, 
     the Comptroller General shall conduct such studies or 
     investigations as the Commission determines to be necessary 
     to carry out its duties under this section.
       (3) Cost estimates by congressional budget office and 
     office of the chief actuary of the centers for medicare & 
     medicaid.--
       (A) In general.--The Director of the Congressional Budget 
     Office or the Chief Actuary of the Center for Medicare & 
     Medicaid Services, or both, shall provide to the Commission, 
     upon the request of the Commission, such cost estimates as 
     the Commission determines to be necessary to carry out its 
     duties under this section.
       (B) Reimbursements.--The Commission shall reimburse the 
     Director of the Congressional Budget Office for expenses 
     relating to the employment in the office of the Director of 
     such additional staff as may be necessary for the Director to 
     comply with requests by the Commission under subparagraph 
     (A).
       (4) Detail of federal employees.--Upon the request of the 
     Commission, the head of any Federal agency is authorized to 
     detail, without reimbursement, any of the personnel of such 
     agency to the Commission to assist the Commission in carrying 
     out its duties under this section. Any such detail shall not 
     interrupt or otherwise affect the civil service status or 
     privileges of the Federal employee.
       (5) Technical assistance.--Upon the request of the 
     Commission, the head of a Federal agency shall provide such 
     technical assistance to the Commission as the Commission 
     determines to be necessary to carry out its duties under this 
     section.
       (6) Use of mails.--The Commission may use the United States 
     mails in the same manner and under the same conditions as 
     Federal agencies and shall, for purposes of the frank, be 
     considered a commission of Congress as described in section 
     3215 of title 39, United States Code.
       (7) Obtaining information.--The Commission may secure 
     directly from any Federal agency information necessary to 
     enable it to carry out its duties under this section, if the 
     information may be disclosed under section 552 of title 5, 
     United States Code. Upon request of the Chairperson of the 
     Commission, the head of each such agency shall furnish such 
     information to the Commission.
       (8) Administrative support services.--Upon the request of 
     the Commission, the Administrator of General Services shall 
     provide to the Commission on a reimbursable basis such 
     administrative support services as the Commission may 
     request.
       (9) Printing.--For purposes of costs relating to printing 
     and binding, including the cost of personnel detailed from 
     the Government Printing Office, the Commission shall be 
     deemed to be a committee of Congress.
       (f) Report.--Not later than October 1, 2012, the Commission 
     shall submit to the President and Congress a report and an 
     implementation bill that shall contain a detailed statement 
     of only those recommendations, findings, and conclusions of 
     the Commission that receive the approval of at least 11 
     members of the Commission.
       (g) Termination.--The Commission shall terminate on the 
     date that is 30 days after the date on which the report and 
     implementation bill is submitted under subsection (f).

      SEC. __03 CONGRESSIONAL CONSIDERATION OF REFORM PROPOSALS.

       (a) Definitions.--In this section:
       (1) Implementation bill.--The term ``implementation bill'' 
     means only a bill that is introduced as provided under 
     subsection (b), and contains the proposed legislation 
     included in the report submitted to Congress under section 
     __02(f), without modification.
       (2) Calendar day.--The term ``calendar day'' means a 
     calendar day other than 1 on which either House is not in 
     session because of an adjournment of more than 3 days to a 
     date certain.
       (b) Introduction; Referral; and Report or Discharge.--
       (1) Introduction.--On the first calendar day on which both 
     Houses are in session immediately following the date on which 
     the report is submitted to Congress under section __02(f), a 
     single implementation bill shall be introduced (by request)--

[[Page S8255]]

       (A) in the Senate by the Majority Leader of the Senate, for 
     himself and the Minority Leader of the Senate, or by Members 
     of the Senate designated by the Majority Leader and Minority 
     Leader of the Senate; and
       (B) in the House of Representatives by the Speaker of the 
     House of Representatives, for himself and the Minority Leader 
     of the House of Representatives, or by Members of the House 
     of Representatives designated by the Speaker and Minority 
     Leader of the House of Representatives.
       (2) Referral.--The implementation bills introduced under 
     paragraph (1) shall be referred to any appropriate committee 
     of jurisdiction in the Senate and any appropriate committee 
     of jurisdiction in the House of Representatives. A committee 
     to which an implementation bill is referred under this 
     paragraph may report such bill to the respective House 
     without amendment.
       (3) Report or discharge.--If a committee to which an 
     implementation bill is referred has not reported such bill by 
     the end of the 15th calendar day after the date of the 
     introduction of such bill, such committee shall be 
     immediately discharged from further consideration of such 
     bill, and upon being reported or discharged from the 
     committee, such bill shall be placed on the appropriate 
     calendar.
       (c) Floor Consideration.--
       (1) In general.--When the committee to which an 
     implementation bill is referred has reported, or has been 
     discharged under subsection (b)(3), it is at any time 
     thereafter in order (even though a previous motion to the 
     same effect has been disagreed to) for any Member of the 
     respective House to move to proceed to the consideration of 
     the implementation bill, and all points of order against the 
     implementation bill (and against consideration of the 
     implementation bill) are waived. The motion is highly 
     privileged in the House of Representatives and is privileged 
     in the Senate and is not debatable. The motion is not subject 
     to amendment, or to a motion to postpone, or to a motion to 
     proceed to the consideration of other business. A motion to 
     reconsider the vote by which the motion is agreed to or 
     disagreed to shall not be in order. If a motion to proceed to 
     the consideration of the implementation bill is agreed to, 
     the implementation bill shall remain the unfinished business 
     of the respective House until disposed of.
       (2) Amendments.--An implementation bill may not be amended 
     in the Senate or the House of Representatives.
       (3) Debate.--Debate on the implementation bill, and on all 
     debatable motions and appeals in connection therewith, shall 
     be limited to not more than 20 hours, which shall be divided 
     equally between those favoring and those opposing the 
     resolution. A motion further to limit debate is in order and 
     not debatable. An amendment to, or a motion to postpone, or a 
     motion to proceed to the consideration of other business, or 
     a motion to recommit the implementation bill is not in order. 
     A motion to reconsider the vote by which the implementation 
     bill is agreed to or disagreed to is not in order.
       (4) Vote on final passage.--Immediately following the 
     conclusion of the debate on an implementation bill, and a 
     single quorum call at the conclusion of the debate if 
     requested in accordance with the rules of the appropriate 
     House, the vote on final passage of the implementation bill 
     shall occur.
       (5) Rulings of the chair on procedure.--Appeals from the 
     decisions of the Chair relating to the application of the 
     rules of the Senate or the House of Representatives, as the 
     case may be, to the procedure relating to an implementation 
     bill shall be decided without debate.
       (d) Coordination With Action by Other House.--If, before 
     the passage by 1 House of an implementation bill of that 
     House, that House receives from the other House an 
     implementation bill, then the following procedures shall 
     apply:
       (1) Nonreferral.--The implementation bill of the other 
     House shall not be referred to a committee.
       (2) Vote on bill of other house.--With respect to an 
     implementation bill of the House receiving the implementation 
     bill--
       (A) the procedure in that House shall be the same as if no 
     implementation bill had been received from the other House; 
     but
       (B) the vote on final passage shall be on the 
     implementation bill of the other House.
       (e) Rules of Senate and House of Representatives.--This 
     section is enacted by Congress--
       (1) as an exercise of the rulemaking power of the Senate 
     and House of Representatives, respectively, and as such it is 
     deemed a part of the rules of each House, respectively, but 
     applicable only with respect to the procedure to be followed 
     in that House in the case of an implementation bill described 
     in subsection (a), and it supersedes other rules only to the 
     extent that it is inconsistent with such rules; and
       (2) with full recognition of the constitutional right of 
     either House to change the rules (so far as relating to the 
     procedure of that House) at any time, in the same manner, and 
     to the same extent as in the case of any other rule of that 
     House.

      SEC. __04. AUTHORIZATION OF APPROPRIATIONS.

       There are authorized to be appropriated such sums as may be 
     necessary to carry out this subtitle for each of fiscal years 
     2012 through 2013.
                                 ______
                                 
  SA 949. Mr. HARKIN submitted an amendment intended to be proposed by 
him to the bill S. 1, to amend title XVIII of the Social Security Act 
to make improvements in the medicare program, to provide prescription 
drug coverage under the medicare program, and for other purposes; which 
was ordered to lie on the table; as follows:

       At the end of subtitle B of title IV, add the following:

     SEC. __. IMPROVED PAYMENT FOR CERTAIN MAMMOGRAPHY SERVICES.

       (a) Exclusion From OPD Fee Schedule.--Section 
     1833(t)(1)(B)(iv) (42 U.S.C. 13951(t)(1)(B)(iv)) is amended 
     by inserting before the period at the end the following: 
     ``and does not include screening mammography (as defined in 
     section 1861(jj)) and unilateral and bilateral diagnostic 
     mammography''.
       (b) Adjustment to Technical Component.--For diagnostic 
     mammography performed on or after January 1, 2004, for which 
     payment is made under the physician fee schedule under 
     section 1848 of the Social Security Act (42 U.S.C. 1395w-4), 
     the Secretary, based on the most recent cost data available, 
     shall provide for an appropriate adjustment in the payment 
     amount for the technical component of the diagnostic 
     mammography.
       (c) Effective Date.--The amendment made by subsection (a) 
     shall apply to mammography performed on or after January 1, 
     2004.
                                 ______
                                 
  SA 950. Mr. PRYOR submitted an amendment intended to be proposed by 
him to the bill S. 1, to amend title XVIII of the Social Security Act 
to make improvements in the medicare program, to provide prescription 
drug coverage under the medicare program, and for other purposes; which 
was ordered to lie on the table; as follows:

       At the appropriate place, add the following:

     SEC. __. EQUAL ACCESS TO COMPETITIVE GLOBAL PRESCRIPTION 
                   MEDICINE PRICES FOR AMERICAN PURCHASERS.

       (a) Definition of Covered Product.--In this section, the 
     term ``covered product'' has the meaning given the term in 
     section 804 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 384).
       (b) Prohibition.--It shall be unlawful for the manufacturer 
     of a covered product or any other person that sells a covered 
     product to refuse to sell to any wholesaler or retailer (or 
     other purchaser representing a group of wholesalers or 
     retailers) of covered products in the United States on terms 
     (including such terms as prompt payment, cash payment, volume 
     purchase, single-site delivery, the use of formularies by 
     purchasers, and any other term that effectively reduces the 
     cost to the manufacturer of supplying the drug) that are not 
     substantially the same as the most favorable (to the 
     purchaser) terms on which the person has sold or has agreed 
     to sell the covered product to any purchaser in Canada.
       (c) Enforcement.--The Secretary of Health and Human 
     Services, or any wholesaler or retailer in the United States 
     aggrieved by a violation of subsection (b), may bring a civil 
     action in United States district court against a person that 
     violates subsection (b) for an order--
       (1) enjoining the violation; and
       (2) awarding damages in the amount that is equal to 3 times 
     the amount of the value of the difference between--
       (A) the terms on which the person sold a covered product to 
     the wholesaler or retailer; and
       (B) the terms on which the person sold the covered product 
     to a person in Canada.
       (d) Effectiveness of Section.--This section takes effect on 
     the date that is 2 years after the date of enactment of this 
     Act, except that this section shall not be in effect during 
     any period after that date in which there is in effect a 
     final regulation promulgated by the Secretary of Health and 
     Human Services permitting the importation or reimportation of 
     prescription drugs under section 804 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 384).

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