[Congressional Record (Bound Edition), Volume 155 (2009), Part 22]
[Senate]
[Pages 29370-29386]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 2860. Mr. FEINGOLD submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       Beginning on page 797, strike line 11 and all that follows 
     through page 801, line 4, and insert the following:

     SEC. 3102A. ELIMINATION OF GEOGRAPHIC PHYSICIAN WORK 
                   ADJUSTMENT FACTOR FROM GEOGRAPHIC INDICES USED 
                   TO ADJUST PAYMENTS UNDER THE PHYSICIAN FEE 
                   SCHEDULE.

       (a) Findings.--Congress finds the following:
       (1) Variations in the geographic physician work adjustment 
     factors under section 1848(e) of the Social Security Act (42 
     U.S.C. 1395w-4(e)) result in inequity between localities in 
     payments under the Medicare physician fee schedule.
       (2) Beneficiaries under the Medicare program that reside in 
     areas where such adjustment factors are high have relatively 
     more access to services that are paid based on such fee 
     schedule.
       (3) There are a number of studies indicating that the 
     market for health care professionals has become nationalized 
     and historically low labor costs in rural and small urban 
     areas have disappeared.
       (4) Elimination of the adjustment factors described in 
     paragraph (1) would equalize the reimbursement rate for 
     services reimbursed under the Medicare physician fee schedule 
     while remaining budget-neutral.
       (b) Elimination.--Section 1848(e) of the Social Security 
     Act (42 U.S.C. 1395w-4(e)) is amended--
       (1) in paragraph (1)(A)(iii), by striking ``an index'' and 
     inserting ``for services provided before January 1, 2010, an 
     index''; and
       (2) in paragraph (2), by inserting ``, for services 
     provided before January 1, 2010,'' after ``paragraph (4)), 
     and''.
       (c) Budget Neutrality Adjustment for Elimination of 
     Geographic Physician Work Adjustment Factor.--Section 1848(d) 
     of the Social Security Act (42 U.S.C. 1395w-4(d)) is 
     amended--
       (1) in paragraph (1)(A), by striking ``The conversion'' and 
     inserting ``Subject to paragraph (10), the conversion''; and
       (2) by adding at the end the following new paragraph:
       ``(10) Budget neutrality adjustment for elimination of 
     geographic physician work adjustment factor.--Before applying 
     an update for a year under this subsection, the Secretary 
     shall (if necessary) provide for an adjustment to the 
     conversion factor for that year to ensure that the aggregate 
     payments under this part in that year shall be equal to 
     aggregate payments that would have been made under such part 
     in that year if the amendments made by section 3102A(b) of 
     the Patient Protection and Affordable Care Act had not been 
     enacted.''.

     SEC. 3102B. CLINICAL ROTATION DEMONSTRATION PROJECT.

       (a) Establishment.--Not later than 6 months after the date 
     of enactment of this Act, the Secretary shall establish a 
     demonstration project that provides for demonstration grants 
     designed to provide financial or other incentives to 
     hospitals to attract educators and clinical practitioners so 
     that hospitals that serve beneficiaries under the Medicare 
     program under title XVIII of the Social Security Act (42 
     U.S.C. 1395 et seq.) who are residents of underserved areas 
     may host clinical rotations.
       (b) Duration of Project.--The demonstration project shall 
     be conducted over a 5-year period.
       (c) Waiver.--The Secretary shall waive such provisions of 
     titles XI and XVIII of the Social Security Act (42 U.S.C. 
     1301 et seq. and 1395 et seq.) as may be necessary to conduct 
     the demonstration project under this section.
       (d) Reports.--The Secretary shall submit to the appropriate 
     committees of Congress interim reports on the demonstration 
     project and a final report on such project within 6 months 
     after the conclusion of the project, together with 
     recommendations for such legislation or administrative action 
     as the Secretary determines to be appropriate.
       (e) Funding.--Out of any funds in the Treasury not 
     otherwise appropriated, there are appropriated to the 
     Secretary to carry out this section, $20,000,000.
       (f) Definitions.--In this section:
       (1) Hospital.--The term ``hospital'' means a subsection (d) 
     hospital (as defined in section 1886(d)(1)(B) of the Social 
     Security Act (42 U.S.C. 1395ww(d)(1)(B))) that had indirect 
     or direct costs of medical education during the most recent 
     cost reporting period preceding the date of enactment of this 
     Act.
       (2) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.
       (3) Underserved area.--The term ``underserved area'' means 
     such medically underserved urban areas and medically 
     underserved rural areas as the Secretary may specify.

     SEC. 3102C. MEDICARE RURAL HEALTH CARE QUALITY IMPROVEMENT 
                   DEMONSTRATION PROJECTS.

       (a) Establishment.--
       (1) In general.--Not later than 6 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (in this section referred to as the ``Secretary'') 
     shall establish not more that 10 demonstration projects to 
     provide for improvements, as recommended by the Institute of 
     Medicine, in the quality of health care provided to 
     individuals residing in rural areas.
       (2) Activities.--Activities under the projects may include 
     public health surveillance, emergency room videoconferencing, 
     virtual libraries, telemedicine, electronic health records, 
     data exchange networks, and any other activities determined 
     appropriate by the Secretary.
       (3) Consultation.--The Secretary shall consult with the 
     Office of Rural Health Policy of the Health Resources and 
     Services Administration, the Agency for Healthcare Research 
     and Quality, and the Centers for Medicare & Medicaid Services 
     in carrying out the provisions of this section.
       (b) Duration.--Each demonstration project under this 
     section shall be conducted over a 4-year period.
       (c) Demonstration Project Sites.--The Secretary shall 
     ensure that the demonstration projects under this section are 
     conducted at a variety of sites representing the diversity of 
     rural communities in the United States.
       (d) Waiver.--The Secretary shall waive such provisions of 
     titles XI and XVIII of the Social Security Act (42 U.S.C. 
     1301 et seq. and 1395 et seq.) as may be necessary to conduct 
     the demonstration projects under this section.
       (e) Independent Evaluation.--The Secretary shall enter into 
     an arrangement with an entity that has experience working 
     directly with rural health systems for the conduct of an 
     independent evaluation of the demonstration projects 
     conducted under this section.
       (f) Reports.--The Secretary shall submit to the appropriate 
     committees of Congress interim reports on each demonstration 
     project and a final report on such project within 6 months 
     after the conclusion of the project. Such reports shall 
     include recommendations regarding the expansion of the 
     project to other areas and recommendations for such other 
     legislative or administrative action as the Secretary 
     determines appropriate.
       (g) Funding.--Out of any funds in the Treasury not 
     otherwise appropriated, there are appropriated to the 
     Secretary to carry out this section, $50,000,000.

     SEC. 3102D. ENSURING PROPORTIONAL REPRESENTATION OF INTERESTS 
                   OF RURAL AREAS ON THE MEDICARE PAYMENT ADVISORY 
                   COMMISSION.

       (a) In General.--Section 1805(c)(2) of the Social Security 
     Act (42 U.S.C. 1395b-6(c)(2)) is amended--
       (1) in subparagraph (A), by inserting ``consistent with 
     subparagraph (E)'' after ``rural representatives''; and
       (2) by adding at the end the following new subparagraph:
       ``(E) Proportional representation of interests of rural 
     areas.--In order to provide a balance between urban and rural 
     representatives under subparagraph (A), the proportion of 
     members who represent the interests of health care providers 
     and Medicare beneficiaries located in rural areas shall be no 
     less than the proportion, of the total number of Medicare 
     beneficiaries, who reside in rural areas.''.
       (b) Effective Date.--The amendments made by subsection (a) 
     shall apply with respect to appointments made to the Medicare 
     Payment Advisory Commission after the date of the enactment 
     of this Act.

     SEC. 3102E. IMPLEMENTATION OF GAO RECOMMENDATIONS REGARDING 
                   GEOGRAPHIC ADJUSTMENT INDICES UNDER THE 
                   MEDICARE PHYSICIAN FEE SCHEDULE.

       Not later than 180 days after the date of enactment of this 
     Act, the Secretary of Health and Human Services shall 
     implement the recommendations contained in the March 2005 GAO 
     report 05-119 entitled ``Medicare Physician Fees: Geographic 
     Adjustment Indices are Valid in Design, but Data and Methods 
     Need Refinement.''.
                                 ______
                                 
  SA 2861. Mr. FEINGOLD submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:


[[Page 29371]]

       At the appropriate place in subtitle C of title IV, insert 
     the following:

     SEC. 4__. AUTOMATED DEFIBRILLATION IN ADAM'S MEMORY ACT.

       Section 312 of the Public Health Service Act (42 U.S.C. 
     244) is amended--
       (1) in subsection (c)(6), after ``clearinghouse'' insert 
     ``, that shall be administered by an organization that has 
     substantial expertise in pediatric education, pediatric 
     medicine, and electrophysiology and sudden death,''; and
       (2) in the first sentence of subsection (e), by striking 
     ``fiscal year 2003'' and all that follows through ``2006'' 
     and inserting ``for each of fiscal years 2003 through 2014''.
                                 ______
                                 
  SA 2862. Mr. KOHL (for himself, Mr. Grassley, Mr. Feingold, Ms. 
Klobuchar, Mr. Franken, Mr. Nelson of Florida, and Mr. Brown) submitted 
an amendment intended to be proposed by him to the bill H.R. 3590, to 
amend the Internal Revenue Code of 1986 to modify the first-time 
homebuyers credit in the case of members of the Armed Forces and 
certain other Federal employees, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

          TITLE __--PRESERVE ACCESS TO AFFORDABLE GENERICS ACT

     SEC. _01. SHORT TITLE.

       This title may be cited as the ``Preserve Access to 
     Affordable Generics Act''.

     SEC. _02. UNLAWFUL COMPENSATION FOR DELAY.

       (a) In General.--The Federal Trade Commission Act (15 
     U.S.C. 44 et seq.) is amended by--
       (1) redesignating section 28 as section 29; and
       (2) inserting before section 29, as redesignated, the 
     following:

     ``SEC. 28. PRESERVING ACCESS TO AFFORDABLE GENERICS.

       ``(a) In General.--
       ``(1) Enforcement proceeding.--The Federal Trade Commission 
     may initiate a proceeding to enforce the provisions of this 
     section against the parties to any agreement resolving or 
     settling, on a final or interim basis, a patent infringement 
     claim, in connection with the sale of a drug product.
       ``(2) Presumption.--
       ``(A) In general.--Subject to subparagraph (B), in such a 
     proceeding, an agreement shall be presumed to have 
     anticompetitive effects and be unlawful if--
       ``(i) an ANDA filer receives anything of value; and
       ``(ii) the ANDA filer agrees to limit or forego research, 
     development, manufacturing, marketing, or sales of the ANDA 
     product for any period of time.
       ``(B) Exception.--The presumption in subparagraph (A) shall 
     not apply if the parties to such agreement demonstrate by 
     clear and convincing evidence that the procompetitive 
     benefits of the agreement outweigh the anticompetitive 
     effects of the agreement.
       ``(b) Competitive Factors.--In determining whether the 
     settling parties have met their burden under subsection 
     (a)(2)(B), the fact finder shall consider--
       ``(1) the length of time remaining until the end of the 
     life of the relevant patent, compared with the agreed upon 
     entry date for the ANDA product;
       ``(2) the value to consumers of the competition from the 
     ANDA product allowed under the agreement;
       ``(3) the form and amount of consideration received by the 
     ANDA filer in the agreement resolving or settling the patent 
     infringement claim;
       ``(4) the revenue the ANDA filer would have received by 
     winning the patent litigation;
       ``(5) the reduction in the NDA holder's revenues if it had 
     lost the patent litigation;
       ``(6) the time period between the date of the agreement 
     conveying value to the ANDA filer and the date of the 
     settlement of the patent infringement claim; and
       ``(7) any other factor that the fact finder, in its 
     discretion, deems relevant to its determination of 
     competitive effects under this subsection.
       ``(c) Limitations.--In determining whether the settling 
     parties have met their burden under subsection (a)(2)(B), the 
     fact finder shall not presume--
       ``(1) that entry would not have occurred until the 
     expiration of the relevant patent or statutory exclusivity; 
     or
       ``(2) that the agreement's provision for entry of the ANDA 
     product prior to the expiration of the relevant patent or 
     statutory exclusivity means that the agreement is pro-
     competitive, although such evidence may be relevant to the 
     fact finder's determination under this section.
       ``(d) Exclusions.--Nothing in this section shall prohibit a 
     resolution or settlement of a patent infringement claim in 
     which the consideration granted by the NDA holder to the ANDA 
     filer as part of the resolution or settlement includes only 
     one or more of the following:
       ``(1) The right to market the ANDA product in the United 
     States prior to the expiration of--
       ``(A) any patent that is the basis for the patent 
     infringement claim; or
       ``(B) any patent right or other statutory exclusivity that 
     would prevent the marketing of such drug.
       ``(2) A payment for reasonable litigation expenses not to 
     exceed $7,500,000.
       ``(3) A covenant not to sue on any claim that the ANDA 
     product infringes a United States patent.
       ``(e) Regulations and Enforcement.--
       ``(1) Regulations.--The Federal Trade Commission may issue, 
     in accordance with section 553 of title 5, United States 
     Code, regulations implementing and interpreting this section. 
     These regulations may exempt certain types of agreements 
     described in subsection (a) if the Commission determines such 
     agreements will further market competition and benefit 
     consumers. Judicial review of any such regulation shall be in 
     the United States District Court for the District of Columbia 
     pursuant to section 706 of title 5, United States Code.
       ``(2) Enforcement.--A violation of this section shall be 
     treated as a violation of section 5.
       ``(3) Judicial review.--Any person, partnership or 
     corporation that is subject to a final order of the 
     Commission, issued in an administrative adjudicative 
     proceeding under the authority of subsection (a)(1), may, 
     within 30 days of the issuance of such order, petition for 
     review of such order in the United States Court of Appeals 
     for the District of Columbia Circuit or the United States 
     Court of Appeals for the circuit in which the ultimate parent 
     entity, as defined at 16 C.F.R. 801.1(a)(3), of the NDA 
     holder is incorporated as of the date that the NDA is filed 
     with the Secretary of the Food and Drug Administration, or 
     the United States Court of Appeals for the circuit in which 
     the ultimate parent entity of the ANDA filer is incorporated 
     as of the date that the ANDA is filed with the Secretary of 
     the Food and Drug Administration. In such a review 
     proceeding, the findings of the Commission as to the facts, 
     if supported by evidence, shall be conclusive.
       ``(f) Antitrust Laws.--Nothing in this section shall be 
     construed to modify, impair or supersede the applicability of 
     the antitrust laws as defined in subsection (a) of the 1st 
     section of the Clayton Act (15 U.S.C. 12(a)) and of section 5 
     of this Act to the extent that section 5 applies to unfair 
     methods of competition. Nothing in this section shall modify, 
     impair, limit or supersede the right of an ANDA filer to 
     assert claims or counterclaims against any person, under the 
     antitrust laws or other laws relating to unfair competition.
       ``(g) Penalties.--
       ``(1) Forfeiture.--Each person, partnership or corporation 
     that violates or assists in the violation of this section 
     shall forfeit and pay to the United States a civil penalty 
     sufficient to deter violations of this section, but in no 
     event greater than 3 times the value received by the party 
     that is reasonably attributable to a violation of this 
     section. If no such value has been received by the NDA 
     holder, the penalty to the NDA holder shall be shall be 
     sufficient to deter violations, but in no event greater than 
     3 times the value given to the ANDA filer reasonably 
     attributable to the violation of this section. Such penalty 
     shall accrue to the United States and may be recovered in a 
     civil action brought by the Federal Trade Commission, in its 
     own name by any of its attorneys designated by it for such 
     purpose, in a district court of the United States against any 
     person, partnership or corporation that violates this 
     section. In such actions, the United States district courts 
     are empowered to grant mandatory injunctions and such other 
     and further equitable relief as they deem appropriate.
       ``(2) Cease and desist.--
       ``(A) In general.--If the Commission has issued a cease and 
     desist order with respect to a person, partnership or 
     corporation in an administrative adjudicative proceeding 
     under the authority of subsection (a)(1), an action brought 
     pursuant to paragraph (1) may be commenced against such 
     person, partnership or corporation at any time before the 
     expiration of one year after such order becomes final 
     pursuant to section 5(g).
       ``(B) Exception.--In an action under subparagraph (A), the 
     findings of the Commission as to the material facts in the 
     administrative adjudicative proceeding with respect to such 
     person's, partnership's or corporation's violation of this 
     section shall be conclusive unless--
       ``(i) the terms of such cease and desist order expressly 
     provide that the Commission's findings shall not be 
     conclusive; or
       ``(ii) the order became final by reason of section 5(g)(1), 
     in which case such finding shall be conclusive if supported 
     by evidence.
       ``(3) Civil penalty.--In determining the amount of the 
     civil penalty described in this section, the court shall take 
     into account--
       ``(A) the nature, circumstances, extent, and gravity of the 
     violation;
       ``(B) with respect to the violator, the degree of 
     culpability, any history of violations, the ability to pay, 
     any effect on the ability to continue doing business, profits 
     earned by the NDA holder, compensation received by the ANDA 
     filer, and the amount of commerce affected; and

[[Page 29372]]

       ``(C) other matters that justice requires.
       ``(4) Remedies in addition.--Remedies provided in this 
     subsection are in addition to, and not in lieu of, any other 
     remedy provided by Federal law. Nothing in this paragraph 
     shall be construed to affect any authority of the Commission 
     under any other provision of law.
       ``(h) Definitions.--In this section:
       ``(1) Agreement.--The term `agreement' means anything that 
     would constitute an agreement under section 1 of the Sherman 
     Act (15 U.S.C. 1) or section 5 of this Act.
       ``(2) Agreement resolving or settling a patent infringement 
     claim.--The term `agreement resolving or settling a patent 
     infringement claim' includes any agreement that is entered 
     into within 30 days of the resolution or the settlement of 
     the claim, or any other agreement that is contingent upon, 
     provides a contingent condition for, or is otherwise related 
     to the resolution or settlement of the claim.
       ``(3) ANDA.--The term `ANDA' means an abbreviated new drug 
     application, as defined under section 505(j) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
       ``(4) ANDA filer.--The term `ANDA filer' means a party who 
     has filed an ANDA with the Food and Drug Administration.
       ``(5) ANDA product.--The term `ANDA product' means the 
     product to be manufactured under the ANDA that is the subject 
     of the patent infringement claim.
       ``(6) Drug product.--The term `drug product' means a 
     finished dosage form (e.g., tablet, capsule, or solution) 
     that contains a drug substance, generally, but not 
     necessarily, in association with 1 or more other ingredients, 
     as defined in section 314.3(b) of title 21, Code of Federal 
     Regulations.
       ``(7) NDA.--The term `NDA' means a new drug application, as 
     defined under section 505(b) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(b)).
       ``(8) NDA holder.--The term `NDA holder' means--
       ``(A) the party that received FDA approval to market a drug 
     product pursuant to an NDA;
       ``(B) a party owning or controlling enforcement of the 
     patent listed in the Approved Drug Products With Therapeutic 
     Equivalence Evaluations (commonly known as the `FDA Orange 
     Book') in connection with the NDA; or
       ``(C) the predecessors, subsidiaries, divisions, groups, 
     and affiliates controlled by, controlling, or under common 
     control with any of the entities described in subparagraphs 
     (A) and (B) (such control to be presumed by direct or 
     indirect share ownership of 50 percent or greater), as well 
     as the licensees, licensors, successors, and assigns of each 
     of the entities.
       ``(9) Patent infringement.--The term `patent infringement' 
     means infringement of any patent or of any filed patent 
     application, extension, reissue, renewal, division, 
     continuation, continuation in part, reexamination, patent 
     term restoration, patents of addition and extensions thereof.
       ``(10) Patent infringement claim.--The term `patent 
     infringement claim' means any allegation made to an ANDA 
     filer, whether or not included in a complaint filed with a 
     court of law, that its ANDA or ANDA product may infringe any 
     patent held by, or exclusively licensed to, the NDA holder of 
     the drug product.
       ``(11) Statutory exclusivity.--The term `statutory 
     exclusivity' means those prohibitions on the approval of drug 
     applications under clauses (ii) through (iv) of section 
     505(c)(3)(E) (5- and 3-year data exclusivity), section 527 
     (orphan drug exclusivity), or section 505A (pediatric 
     exclusivity) of the Federal Food, Drug, and Cosmetic Act .''.
       (b) Effective Date.--Section 28 of the Federal Trade 
     Commission Act, as added by this section, shall apply to all 
     agreements described in section 28(a)(1) of that Act entered 
     into after November 15, 2009. Section 28(g) of the Federal 
     Trade Commission Act, as added by this section, shall not 
     apply to agreements entered into before the date of enactment 
     of this title.

     SEC. _03. NOTICE AND CERTIFICATION OF AGREEMENTS.

       (a) Notice of All Agreements.--Section 1112(c)(2) of the 
     Medicare Prescription Drug, Improvement, and Modernization 
     Act of 2003 (21 U.S.C. 355 note) is amended by--
       (1) striking ``the Commission the'' and inserting the 
     following: ``the Commission--
       ``(1) the'';
       (2) striking the period and inserting ``; and''; and
       (3) inserting at the end the following:
       ``(2) any other agreement the parties enter into within 30 
     days of entering into an agreement covered by subsection (a) 
     or (b).''.
       (b) Certification of Agreements.--Section 1112 of such Act 
     is amended by adding at the end the following:
       ``(d) Certification.--The Chief Executive Officer or the 
     company official responsible for negotiating any agreement 
     required to be filed under subsection (a), (b), or (c) shall 
     execute and file with the Assistant Attorney General and the 
     Commission a certification as follows: `I declare that the 
     following is true, correct, and complete to the best of my 
     knowledge: The materials filed with the Federal Trade 
     Commission and the Department of Justice under section 1112 
     of subtitle B of title XI of the Medicare Prescription Drug, 
     Improvement, and Modernization Act of 2003, with respect to 
     the agreement referenced in this certification: (1) represent 
     the complete, final, and exclusive agreement between the 
     parties; (2) include any ancillary agreements that are 
     contingent upon, provide a contingent condition for, or are 
     otherwise related to, the referenced agreement; and (3) 
     include written descriptions of any oral agreements, 
     representations, commitments, or promises between the parties 
     that are responsive to subsection (a) or (b) of such section 
     1112 and have not been reduced to writing.'.''.

     SEC. _04. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.

       Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug and 
     Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amended by 
     inserting ``section 28 of the Federal Trade Commission Act 
     or'' after ``that the agreement has violated''.

     SEC. _05. COMMISSION LITIGATION AUTHORITY.

       Section 16(a)(2) of the Federal Trade Commission Act (15 
     U.S.C. 56(a)(2)) is amended--
       (1) in subparagraph (D), by striking ``or'' after the 
     semicolon;
       (2) in subparagraph (E), by inserting ``or'' after the 
     semicolon; and
       (3) inserting after subparagraph (E) the following:
       ``(F) under section 28;''.

     SEC. _06. STATUTE OF LIMITATIONS.

       The Commission shall commence any enforcement proceeding 
     described in section 28 of the Federal Trade Commission Act, 
     as added by section _02, except for an action described in 
     section 28(g)(2) of the Federal Trade Commission Act, not 
     later than 3 years after the date on which the parties to the 
     agreement file the Notice of Agreement as provided by 
     sections 1112(c)(2) and (d) of the Medicare Prescription Drug 
     Improvement and Modernization Act of 2003 (21 U.S.C. 355 
     note).

     SEC. _07. SEVERABILITY.

       If any provision of this title, an amendment made by this 
     title, or the application of such provision or amendment to 
     any person or circumstance is held to be unconstitutional, 
     the remainder of this title, the amendments made by this 
     title, and the application of the provisions of such title or 
     amendments to any person or circumstance shall not be 
     affected thereby.
                                 ______
                                 
  SA 2863. Mr. VITTER submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end, add the following:

               TITLE X--IMPORTATION OF PRESCRIPTION DRUGS

     SEC. 10001. SHORT TITLE.

       This title may be cited as the ``Pharmaceutical Market 
     Access Act of 2009''

     SEC. 10002. PURPOSES.

       The purposes of this title are to--
       (1) give all Americans immediate relief from the 
     outrageously high cost of pharmaceuticals;
       (2) reverse the perverse economics of the American 
     pharmaceutical market;
       (3) allow the importation of prescription drugs only if the 
     drugs and facilities where such drugs are manufactured are 
     approved by the Food and Drug Administration, and to exclude 
     pharmaceutical narcotics; and
       (4) ensure continued integrity to the prescription drug 
     supply of the United States by--
       (A) requiring that imported prescription drugs be packaged 
     and shipped using counterfeit-resistant technologies;
       (B) requiring Internet pharmacies to register with the 
     United States Government for Americans to verify authenticity 
     before purchases over the Internet;
       (C) requiring all foreign sellers to register with United 
     States Government and submit to facility inspections by the 
     Government without prior notice; and
       (D) limiting the eligible countries from which prescription 
     drugs may be imported to Canada, member countries of the 
     European Union, and other highly industrialized nations with 
     safe pharmaceutical infrastructures.

     SEC. 10003. AMENDMENTS TO SECTION 804 OF THE FEDERAL FOOD, 
                   DRUG, AND COSMETIC ACT.

       (a) Definitions.--Section 804(a) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 384(a)) is amended to read as 
     follows:
       ``(a) Definitions.--In this section:
       ``(1) Importer.--The term `importer' means a pharmacy, 
     group of pharmacies, pharmacist, or wholesaler.
       ``(2) Permitted country.--The term `permitted country' 
     means Australia, Canada, Israel, Japan, New Zealand, 
     Switzerland, South Africa, Austria, Belgium, Denmark, 
     Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, 
     Netherlands, Portugal, Spain, Sweden, the United Kingdom, 
     Iceland, Liechtenstein, and Norway, except that the 
     Secretary--

[[Page 29373]]

       ``(A) may add a country, union, or economic area as a 
     permitted country for purposes of this section if the 
     Secretary determines that the country, union, or economic 
     area has a pharmaceutical infrastructure that is 
     substantially equivalent or superior to the pharmaceutical 
     infrastructure of the United States, taking into 
     consideration pharmacist qualifications, pharmacy storage 
     procedures, the drug distribution system, the drug dispensing 
     system, and market regulation; and
       ``(B) may remove a country, union, or economic area as a 
     permitted country for purposes of this section if the 
     Secretary determines that the country, union, or economic 
     area does not have such a pharmaceutical infrastructure.
       ``(3) Pharmacist.--The term `pharmacist' means a person 
     licensed by the relevant governmental authority to practice 
     pharmacy, including the dispensing and selling of 
     prescription drugs.
       ``(4) Pharmacy.--The term `pharmacy' means a person that is 
     licensed by the relevant governmental authority to engage in 
     the business of selling prescription drugs that employs 1 or 
     more pharmacists.
       ``(5) 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;
       ``(E) a drug that is inhaled during surgery; or
       ``(F) a drug which is a parenteral drug, the importation of 
     which pursuant to subsection (b) is determined by the 
     Secretary to pose a threat to the public health, in which 
     case section 801(d)(1) shall continue to apply.
       ``(6) Qualifying drug.--The term `qualifying drug' means a 
     prescription drug that--
       ``(A) is approved pursuant to an application submitted 
     under section 505(b)(1); and
       ``(B) is not--
       ``(i) a drug manufactured through 1 or more biotechnology 
     processes;
       ``(ii) a drug that is required to be refrigerated; or
       ``(iii) a photoreactive drug.
       ``(7) Qualifying internet pharmacy.--The term `qualifying 
     Internet pharmacy' means a registered exporter that dispenses 
     qualifying drugs to individuals over an Internet Web site.
       ``(8) 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.
       ``(9) Registered exporter.--The term `registered exporter' 
     means a person that is in the business of exporting a drug to 
     persons in the United States (or that seeks to be in such 
     business), for which a registration under this section has 
     been approved and is in effect.
       ``(10) 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.--Section 804(b) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 384(b)) is amended to read as 
     follows:
       ``(b) Regulations.--Not later than 180 days after the date 
     of enactment of the Pharmaceutical Market Access Act of 2009, 
     the Secretary, after consultation with the United States 
     Trade Representative and the Commissioner of the U.S. Customs 
     and Border Protection, shall promulgate regulations 
     permitting pharmacists, pharmacies, and wholesalers to import 
     qualifying drugs from permitted countries into the United 
     States.''.
       (c) Limitation.--Section 804(c) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 384(c)) is amended by striking 
     ``prescription drug'' each place it appears and inserting 
     ``qualifying drug''.
       (d) Information and Records.--Section 804(d)(1) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(d)(1)) is 
     amended--
       (1) by striking subparagraph (G) and redesignating 
     subparagraphs (H) through (N) as subparagraphs (G) through 
     (M), respectively;
       (2) in subparagraph (H) (as so redesignated), by striking 
     ``telephone number, and professional license number (if 
     any)'' and inserting ``and telephone number''; and
       (3) in subparagraph (L) (as so redesignated), by striking 
     ``(J) and (L)'' and inserting ``(I) and (K)''.
       (e) Testing.--Section 804(e) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 384(e)) is amended to read as 
     follows:
       ``(e) Testing.--The regulations under subsection (b) shall 
     require that the testing described under subparagraphs (I) 
     and (K) of subsection (d)(1) be conducted by the importer of 
     the qualifying drug, unless the qualifying drug is subject to 
     the requirements under section 505E for counterfeit-resistant 
     technologies.''.
       (f) Registration of Exporters; Inspections.--Section 804(f) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     384(f)) is amended to read as follows:
       ``(f) Registration of Exporters; Inspections.--
       ``(1) In general.--Any person that seeks to be a registered 
     exporter (referred to in this subsection as the `registrant') 
     shall submit to the Secretary a registration that includes 
     the following:
       ``(A) The name of the registrant and identification of all 
     places of business of the registrant that relate to 
     qualifying drugs, including each warehouse or other facility 
     owned or controlled by, or operated for, the registrant.
       ``(B) An agreement by the registrant to--
       ``(i) make its places of business that relate to qualifying 
     drugs (including warehouses and other facilities owned or 
     controlled by, or operated for, the exporter) and records 
     available to the Secretary for on-site inspections, without 
     prior notice, for the purpose of determining whether the 
     registrant is in compliance with this Act's requirements;
       ``(ii) export only qualifying drugs;
       ``(iii) export only to persons authorized to import the 
     drugs;
       ``(iv) notify the Secretary of a recall or withdrawal of a 
     qualifying drug distributed in a permitted country to or from 
     which the registrant has exported or imported, or intends to 
     export or import, to the United States;
       ``(v) monitor compliance with registration conditions and 
     report any noncompliance promptly;
       ``(vi) submit a compliance plan showing how the registrant 
     will correct violations, if any; and
       ``(vii) promptly notify the Secretary of changes in the 
     registration information of the registrant.
       ``(2) Notice of approval or disapproval.--
       ``(A) In general.--Not later than 90 days after receiving a 
     completed registration from a registrant, the Secretary 
     shall--
       ``(i) notify such registrant of receipt of the 
     registration;
       ``(ii) assign such registrant a registration number; and
       ``(iii) approve or disapprove the application.
       ``(B) Disapproval of application.--
       ``(i) In general.--The Secretary shall disapprove a 
     registration, and notify the registrant of such disapproval, 
     if the Secretary has reason to believe that such registrant 
     is not in compliance with a registration condition.
       ``(ii) Subsequent approval.--The Secretary may subsequently 
     approve a registration that was denied under clause (i) if 
     the Secretary finds that the registrant is in compliance with 
     all registration conditions.
       ``(3) List.--The Secretary shall--
       ``(A) maintain an up-to-date list of registered exporters 
     (including qualifying Internet pharmacies that sell 
     qualifying drugs to individuals);
       ``(B) make such list available to the public on the 
     Internet Web site of the Food and Drug Administration and via 
     a toll-free telephone number; and
       ``(C) update such list promptly after the approval of a 
     registration under this subsection.
       ``(4) Education of consumers.--The Secretary shall carry 
     out activities, by use of the Internet Web site and toll-free 
     telephone number under paragraph (3), that educate consumers 
     with regard to the availability of qualifying drugs for 
     import for personal use under this section, including 
     information on how to verify whether an exporter is 
     registered.
       ``(5) Inspection of importers and registered exporters.--
     The Secretary shall inspect the warehouses, other facilities, 
     and records of importers and registered exporters as often as 
     the Secretary determines necessary to ensure that such 
     importers and registered exporters are in compliance with 
     this section.''.
       (g) Suspension of Importation.--Section 804(g) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(g)) is 
     amended by--
       (1) striking ``and the Secretary determines that the public 
     is adequately protected from counterfeit and violative 
     prescription drugs being imported under subsection (b)''; and
       (2) by adding after the period at the end the following: 
     ``The Secretary shall reinstate the importation by a specific 
     importer upon a determination by the Secretary that the 
     violation has been corrected and that the importer has 
     demonstrated that further violations will not occur. This 
     subsection shall not apply to a prescription drug imported by 
     an individual, or to a prescription drug shipped to an 
     individual by a qualifying Internet pharmacy.''.
       (h) Waiver Authority for Individuals.--Section 804(j) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(j)) 
     is amended to read as follows:
       ``(j) Importation by Individuals.--
       ``(1) In general.--Not later than 180 days after the 
     enactment of the Pharmaceutical Market Access Act of 2009, 
     the Secretary shall by regulation permit an individual to 
     import a drug from a permitted country to the United States 
     if the drug is--
       ``(A) a qualifying drug;
       ``(B) imported from a licensed pharmacy or qualifying 
     Internet pharmacy;

[[Page 29374]]

       ``(C) for personal use by an individual, or family member 
     of the individual, not for resale;
       ``(D) in a quantity that does not exceed a 90-day supply 
     during any 90-day period; and
       ``(E) accompanied by a copy of a prescription for the drug, 
     which--
       ``(i) is valid under applicable Federal and State laws; and
       ``(ii) was issued by a practitioner who is authorized to 
     administer prescription drugs.
       ``(2) Drugs dispensed outside the united states.--An 
     individual may import a drug from a country that is not a 
     permitted country if--
       ``(A) the drug was dispensed to the individual while the 
     individual was in such country, and the drug was dispensed in 
     accordance with the laws and regulations of such country;
       ``(B) the individual is entering the United States and the 
     drug accompanies the individual at the time of entry;
       ``(C) the drug is approved for commercial distribution in 
     the country in which the drug was obtained;
       ``(D) the drug does not appear to be adulterated; and
       ``(E) the quantity of the drug does not exceed a 14-day 
     supply.''.
       (i) Repeal of Certain Provisions.--Section 804 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) is 
     amended by striking subsections (l) and (m).

     SEC. 10004. REGISTRATION FEES.

       Subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379f et seq.) is amended by adding at 
     the end the following:

        ``PART 6--FEES RELATING TO PRESCRIPTION DRUG IMPORTATION

     ``SEC. 743. FEES RELATING TO PRESCRIPTION DRUG IMPORTATION.

       ``(a) Registration Fee.--The Secretary shall establish a 
     registration fee program under which a registered exporter 
     under section 804 shall be required to pay an annual fee to 
     the Secretary in accordance with this subsection.
       ``(b) Collection.--
       ``(1) Collection on initial registration.--A fee under this 
     section shall be payable for the fiscal year in which the 
     registered exporter first submits a registration under 
     section 804 (or reregisters under that section if that person 
     has withdrawn its registration and subsequently reregisters) 
     in a amount of $10,000, due on the date the exporter first 
     submits a registration to the Secretary under section 804.
       ``(2) Collection in subsequent years.--After the fee is 
     paid for the first fiscal year, the fee described under this 
     subsection shall be payable on or before October 1 of each 
     year.
       ``(3) One fee per facility.--The fee shall be paid only 
     once for each registered exporter for a fiscal year in which 
     the fee is payable.
       ``(c) Fee Amount.--
       ``(1) In general.--Subject to subsection (b)(1), the amount 
     of the fee shall be determined each year by the Secretary and 
     shall be based on the anticipated costs to the Secretary of 
     enforcing the amendments made by the Pharmaceutical Market 
     Access Act of 2009 in the subsequent fiscal year.
       ``(2) Limitation.--
       ``(A) In general.--The aggregate total of fees collected 
     under this section shall not exceed 1 percent of the total 
     price of drugs exported annually to the United States by 
     registered exporters under this section.
       ``(B) Reasonable estimate.--Subject to the limitation 
     described in subparagraph (A), a fee under this subsection 
     for an exporter shall be an amount that is a reasonable 
     estimate by the Secretary of the annual share of the exporter 
     of the volume of drugs exported by exporters under this 
     section.
       ``(d) Use of Fees.--The fees collected under this section 
     shall be used for the sole purpose of administering this 
     section with respect to registered exporters, including the 
     costs associated with--
       ``(1) inspecting the facilities of registered exporters, 
     and of other entities in the chain of custody of a qualifying 
     drug;
       ``(2) developing, implementing, and maintaining a system to 
     determine registered exporters' compliance with the 
     registration conditions under the Pharmaceutical Market 
     Access Act of 2009, including when shipments of qualifying 
     drugs are offered for import into the United States; and
       ``(3) inspecting such shipments, as necessary, when offered 
     for import into the United States to determine if any such 
     shipment should be refused admission.
       ``(e) Annual Fee Setting.--The Secretary shall establish, 
     60 days before the beginning of each fiscal year beginning 
     after September 30, 2009, for that fiscal year, registration 
     fees.
       ``(f) Effect of Failure To Pay Fees.--
       ``(1) Due date.--A fee payable under this section shall be 
     paid by the date that is 30 days after the date on which the 
     fee is due.
       ``(2) Failure to pay.--If a registered exporter subject to 
     a fee under this section fails to pay the fee, the Secretary 
     shall not permit the registered exporter to engage in 
     exportation to the United States or offering for exportation 
     prescription drugs under this Act until all such fees owed by 
     that person are paid.
       ``(g) Reports.--
       ``(1) Fee establishment.--Not later than 60 days before the 
     beginning of each fiscal year, the Secretary shall--
       ``(A) publish registration fees under this section for that 
     fiscal year;
       ``(B) hold a meeting at which the public may comment on the 
     recommendations; and
       ``(C) provide for a period of 30 days for the public to 
     provide written comments on the recommendations.
       ``(2) Performance and fiscal report.--Beginning with fiscal 
     year 2009, not later than 60 days after the end of each 
     fiscal year during which fees are collected under this 
     section, the Secretary shall submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report that describes--
       ``(A) implementation of the registration fee authority 
     during the fiscal year; and
       ``(B) the use by the Secretary of the fees collected during 
     the fiscal year for which the report is made.''.

     SEC. 10005. COUNTERFEIT-RESISTANT TECHNOLOGY.

       (a) Misbranding.--Section 502 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352; deeming drugs and devices to 
     be misbranded) is amended by adding at the end the following:
       ``(aa) If it is a drug subject to section 503(b), unless 
     the packaging of such drug complies with the requirements of 
     section 505E for counterfeit-resistant technologies.''.
       (b) Requirements.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 505D the following:

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

       ``(a) Incorporation of Counterfeit-Resistant Technologies 
     Into Prescription Drug Packaging.--The Secretary shall 
     require that the packaging of any drug subject to section 
     503(b) incorporate--
       ``(1) overt optically variable counterfeit-resistant 
     technologies that are described in subsection (b) and comply 
     with the standards of subsection (c); or
       ``(2) technologies that have an equivalent function of 
     security, as determined by the Secretary.
       ``(b) Eligible Technologies.--Technologies described in 
     this subsection--
       ``(1) shall be visible to the naked eye, providing for 
     visual identification of product authenticity without the 
     need for readers, microscopes, lighting devices, or scanners;
       ``(2) shall be similar to that used by the Bureau of 
     Engraving and Printing to secure United States currency;
       ``(3) shall be manufactured and distributed in a highly 
     secure, tightly controlled environment; and
       ``(4) should incorporate additional layers of non-visible 
     covert security features up to and including forensic 
     capability.
       ``(c) Standards for Packaging.--
       ``(1) Multiple elements.--For the purpose of making it more 
     difficult to counterfeit the packaging of drugs subject to 
     section 503(b), manufacturers of the drugs shall incorporate 
     the technologies described in subsection (b) into multiple 
     elements of the physical packaging of the drugs, including 
     blister packs, shrink wrap, package labels, package seals, 
     bottles, and boxes.
       ``(2) Labeling of shipping container.--Shipments of drugs 
     described in subsection (a) shall include a label on the 
     shipping container that incorporates the technologies 
     described in subsection (b), so that officials inspecting the 
     packages will be able to determine the authenticity of the 
     shipment. Chain of custody procedures shall apply to such 
     labels and shall include procedures applicable to contractual 
     agreements for the use and distribution of the labels, 
     methods to audit the use of the labels, and database access 
     for the relevant governmental agencies for audit or 
     verification of the use and distribution of the labels.
       ``(d) Effective Date.--This section shall take effect 180 
     days after the date of enactment of the Pharmaceutical Market 
     Access Act of 2009.''.

     SEC. 10006. PROHIBITED ACTS.

       Section 301 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 331) is amended by inserting after subsection (k) the 
     following:
       ``(l) The failure to register in accordance with section 
     804(f) or to import or offer to import a prescription drug in 
     violation of a suspension order under section 804(g).''.

     SEC. 10007. PATENTS.

       Section 271 of title 35, United States Code, is amended--
       (1) by redesignating subsections (h) and (i) as subsections 
     (i) and (j), respectively; and
       (2) by inserting after subsection (g) the following:
       ``(h) It shall not be an act of infringement to use, offer 
     to sell, or sell within the United States or to import into 
     the United States any patented invention under section 804 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) that 
     was first sold abroad by or under authority of the owner or 
     licensee of such patent.''.

     SEC. 10008. OTHER ENFORCEMENT ACTIONS.

       (a) In General.--Section 804 of the Federal Food, Drug, and 
     Cosmetic Act, as amended by section 10003, is amended by 
     adding at the end the following:
       ``(l) Unfair or Discriminatory Acts and Practices.--

[[Page 29375]]

       ``(1) In general.--It is unlawful for a manufacturer, 
     directly or indirectly (including by being a party to a 
     licensing or other agreement) to--
       ``(A) discriminate by charging a higher price for a 
     prescription drug sold to a person in a permitted country 
     that exports a prescription drug to the United States under 
     this section than the price that is charged to another person 
     that is in the same country and that does not export a 
     prescription drug into the United States under this section;
       ``(B) discriminate by charging a higher price for a 
     prescription drug sold to a person that distributes, sells, 
     or uses a prescription drug imported into the United States 
     under this section than the price that is charged to another 
     person in the United States that does not import a 
     prescription drug under this section, or that does not 
     distribute, sell, or use such a drug;
       ``(C) discriminate by denying supplies of a prescription 
     drug to a person in a permitted country that exports a 
     prescription drug to the United States under this section or 
     distributes, sells, or uses a prescription drug imported into 
     the United States under this section;
       ``(D) discriminate by publicly, privately, or otherwise 
     refusing to do business with a person in a permitted country 
     that exports a prescription drug to the United States under 
     this section or distributes, sells, or uses a prescription 
     drug imported into the United States under this section;
       ``(E) discriminate by specifically restricting or delaying 
     the supply of a prescription drug to a person in a permitted 
     country that exports a prescription drug to the United States 
     under this section or distributes, sells, or uses a 
     prescription drug imported into the United States under this 
     section;
       ``(F) cause there to be a difference (including a 
     difference in active ingredient, route of administration, 
     dosage form, strength, formulation, manufacturing 
     establishment, manufacturing process, or person that 
     manufactures the drug) between a prescription drug for 
     distribution in the United States and the drug for 
     distribution in a permitted country for the purpose of 
     restricting importation of the drug into the United States 
     under this section;
       ``(G) refuse to allow an inspection authorized under this 
     section of an establishment that manufactures a prescription 
     drug that may be imported or offered for import under this 
     section;
       ``(H) fail to conform to the methods used in, or the 
     facilities used for, the manufacturing, processing, packing, 
     or holding of a prescription drug that may be imported or 
     offered for import under this section to good manufacturing 
     practice under this Act;
       ``(I) become a party to a licensing or other agreement 
     related to a prescription drug that fails to provide for 
     compliance with all requirements of this section with respect 
     to such prescription drug or that has the effect of 
     prohibiting importation of the drug under this section; or
       ``(J) engage in any other action that the Federal Trade 
     Commission determines to discriminate against a person that 
     engages in, or to impede, delay, or block the process for, 
     the importation of a prescription drug under this section.
       ``(2) Affirmative defense.--It shall be an affirmative 
     defense to a charge that a person has discriminated under 
     subparagraph (A), (B), (C), (D), or (E) of paragraph (1) that 
     the higher price charged for a prescription drug sold to a 
     person, the denial of supplies of a prescription drug to a 
     person, the refusal to do business with a person, or the 
     specific restriction or delay of supplies to a person is not 
     based, in whole or in part, on--
       ``(A) the person exporting or importing a prescription drug 
     into the United States under this section; or
       ``(B) the person distributing, selling, or using a 
     prescription drug imported into the United States under this 
     section.
       ``(3) Presumption and affirmative defense.--
       ``(A) Presumption.--A difference (including a difference in 
     active ingredient, route of administration, dosage form, 
     strength, formulation, manufacturing establishment, 
     manufacturing process, or person that manufactures the drug) 
     created after January 1, 2009, between a prescription drug 
     for distribution in the United States and the drug for 
     distribution in a permitted country shall be presumed under 
     paragraph (1)(F) to be for the purpose of restricting 
     importation of the drug into the United States under this 
     section.
       ``(B) Affirmative defense.--It shall be an affirmative 
     defense to the presumption under subparagraph (A) that--
       ``(i) the difference was required by the country in which 
     the drug is distributed; or
       ``(ii) the Secretary has determined that the difference was 
     necessary to improve the safety or effectiveness of the drug.
       ``(4) Effect of subsection.--
       ``(A) Sales in other countries.--This subsection applies 
     only to the sale or distribution of a prescription drug in a 
     country if the manufacturer of the drug chooses to sell or 
     distribute the drug in the country. Nothing in this 
     subsection shall be construed to compel the manufacturer of a 
     drug to distribute or sell the drug in a country.
       ``(B) Discounts to insurers, health plans, pharmacy benefit 
     managers, and covered entities.--Nothing in this subsection 
     shall be construed to--
       ``(i) prevent or restrict a manufacturer of a prescription 
     drug from providing discounts to an insurer, health plan, 
     pharmacy benefit manager in the United States, or covered 
     entity in the drug discount program under section 340B of the 
     Public Health Service Act (42 U.S.C. 256b) in return for 
     inclusion of the drug on a formulary;
       ``(ii) require that such discounts be made available to 
     other purchasers of the prescription drug; or
       ``(iii) prevent or restrict any other measures taken by an 
     insurer, health plan, or pharmacy benefit manager to 
     encourage consumption of such prescription drug.
       ``(C) Charitable contributions.--Nothing in this subsection 
     shall be construed to--
       ``(i) prevent a manufacturer from donating a prescription 
     drug, or supplying a prescription drug at nominal cost, to a 
     charitable or humanitarian organization, including the United 
     Nations and affiliates, or to a government of a foreign 
     country; or
       ``(ii) apply to such donations or supplying of a 
     prescription drug.
       ``(5) Enforcement.--
       ``(A) Unfair or deceptive act or practice.--A violation of 
     this subsection shall be treated as a violation of a rule 
     defining an unfair or deceptive act or practice prescribed 
     under section 18(a)(1)(B) of the Federal Trade Commission 
     Act.
       ``(B) Actions by the commission.--The Federal Trade 
     Commission--
       ``(i) shall enforce this subsection in the same manner, by 
     the same means, and with the same jurisdiction, powers, and 
     duties as though all applicable terms and provisions of the 
     Federal Trade Commission Act were incorporated into and made 
     a part of this section; and
       ``(ii) may seek monetary relief threefold the damages 
     sustained.
       ``(6) Actions by states.--
       ``(A) In general.--
       ``(i) Civil actions.--The attorney general of a State may 
     bring a civil action on behalf of the residents of the State, 
     and persons doing business in the State, in a district court 
     of the United States of appropriate jurisdiction for a 
     violation of paragraph (1) to--

       ``(I) enjoin that practice;
       ``(II) enforce compliance with this subsection;
       ``(III) obtain damages, restitution, or other compensation 
     on behalf of residents of the State and persons doing 
     business in the State, including threefold the damages; or
       ``(IV) obtain such other relief as the court may consider 
     to be appropriate.

       ``(ii) Notice.--

       ``(I) In general.--Before filing an action under clause 
     (i), the attorney general of the State involved shall provide 
     to the Federal Trade Commission--

       ``(aa) written notice of that action; and
       ``(bb) a copy of the complaint for that action.

       ``(II) Exemption.--Subclause (I) shall not apply with 
     respect to the filing of an action by an attorney general of 
     a State under this paragraph, if the attorney general 
     determines that it is not feasible to provide the notice 
     described in that subclause before filing of the action. In 
     such case, the attorney general of a State shall provide 
     notice and a copy of the complaint to the Federal Trade 
     Commission at the same time as the attorney general files the 
     action.

       ``(B) Intervention.--
       ``(i) In general.--On receiving notice under subparagraph 
     (A)(ii), the Commission shall have the right to intervene in 
     the action that is the subject of the notice.
       ``(ii) Effect of intervention.--If the Commission 
     intervenes in an action under subparagraph (A), it shall have 
     the right--

       ``(I) to be heard with respect to any matter that arises in 
     that action; and
       ``(II) to file a petition for appeal.

       ``(C) Construction.--For purposes of bringing any civil 
     action under subparagraph (A), nothing in this subsection 
     shall be construed to prevent an attorney general of a State 
     from exercising the powers conferred on the attorney general 
     by the laws of that State to--
       ``(i) conduct investigations;
       ``(ii) administer oaths or affirmations; or
       ``(iii) compel the attendance of witnesses or the 
     production of documentary and other evidence.
       ``(D) Actions by the commission.--
       ``(i) In general.--In any case in which an action is 
     instituted by or on behalf of the Commission for a violation 
     of paragraph (1), a State may not, during the pendency of 
     that action, institute an action under subparagraph (A) for 
     the same violation against any defendant named in the 
     complaint in that action.
       ``(ii) Intervention.--An attorney general of a State may 
     intervene, on behalf of the residents of that State, in an 
     action instituted by the Commission.
       ``(iii) Effect of intervention.--If an attorney general of 
     a State intervenes in an action instituted by the Commission, 
     such attorney general shall have the right--

       ``(I) to be heard with respect to any matter that arises in 
     that action; and
       ``(II) to file a petition for appeal.

[[Page 29376]]

       ``(E) Venue.--Any action brought under subparagraph (A) may 
     be brought in the district court of the United States that 
     meets applicable requirements relating to venue under section 
     1391 of title 28, United States Code.
       ``(F) Service of process.--In an action brought under 
     subparagraph (A), process may be served in any district in 
     which the defendant--
       ``(i) is an inhabitant; or
       ``(ii) may be found.
       ``(G) Limitation of actions.--Any action under this 
     paragraph to enforce a cause of action under this subsection 
     by the Federal Trade Commission or the attorney general of a 
     State shall be forever barred unless commenced within 5 years 
     after the Federal Trade Commission, or the attorney general, 
     as the case may be, knew or should have known that the cause 
     of action accrued. No cause of action barred under existing 
     law on the effective date of the Pharmaceutical Market Access 
     Act of 2009 shall be revived by such Act.
       ``(H) Measurement of damages.--In any action under this 
     paragraph to enforce a cause of action under this subsection 
     in which there has been a determination that a defendant has 
     violated a provision of this subsection, damages may be 
     proved and assessed in the aggregate by statistical or 
     sampling methods, by the computation of illegal overcharges 
     or by such other reasonable system of estimating aggregate 
     damages as the court in its discretion may permit without the 
     necessity of separately proving the individual claim of, or 
     amount of damage to, persons on whose behalf the suit was 
     brought.
       ``(I) Exclusion on duplicative relief.--The district court 
     shall exclude from the amount of monetary relief awarded in 
     an action under this paragraph brought by the attorney 
     general of a State any amount of monetary relief which 
     duplicates amounts which have been awarded for the same 
     injury.
       ``(7) Effect on antitrust laws.--Nothing in this subsection 
     shall be construed to modify, impair, or supersede the 
     operation of the antitrust laws. For the purpose of this 
     subsection, the term `antitrust laws' has the meaning given 
     it in the first section of the Clayton Act, except that it 
     includes section 5 of the Federal Trade Commission Act to the 
     extent that such section 5 applies to unfair methods of 
     competition.
       ``(8) Manufacturer.--In this subsection, the term 
     `manufacturer' means any entity, including any affiliate or 
     licensee of that entity, that is engaged in--
       ``(A) the production, preparation, propagation, 
     compounding, conversion, or processing of a prescription 
     drug, either directly or indirectly by extraction from 
     substances of natural origin, or independently by means of 
     chemical synthesis, or by a combination of extraction and 
     chemical synthesis; or
       ``(B) the packaging, repackaging, labeling, relabeling, or 
     distribution of a prescription drug.''.
       (b) Regulations.--The Federal Trade Commission shall 
     promulgate regulations to carry out the enforcement program 
     under section 804(l) of the Federal Food, Drug, and Cosmetic 
     Act (as added by subsection (a)).
       (c) Suspension and Termination of Exporters.--Section 
     804(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     384(g)), as amended by section 10003(g), is amended by--
       (1) striking ``Suspension of Importation.--The Secretary'' 
     and inserting ``Suspension of Importation.--
       ``(1) In general.--The Secretary''; and
       (2) adding at the end the following:
       ``(2) Suspension and termination of exporters.--
       ``(A) Suspension.--With respect to the effectiveness of a 
     registration submitted under subsection (f) by a registered 
     exporter:
       ``(i) Subject to clause (ii), if the Secretary determines, 
     after notice and opportunity for a hearing, that the 
     registered exporter has failed to maintain substantial 
     compliance with all registration conditions, the Secretary 
     may suspend the registration.
       ``(ii) If the Secretary determines that, under color of the 
     registration, the registered exporter has exported a drug 
     that is not a qualifying drug, or a drug that does not meet 
     the criteria under this section, or has exported a qualifying 
     drug to an individual in violation of this section, the 
     Secretary shall immediately suspend the registration. A 
     suspension under the preceding sentence is not subject to the 
     provision by the Secretary of prior notice, and the Secretary 
     shall provide to the registered exporter involved an 
     opportunity for a hearing not later than 10 days after the 
     date on which the registration is suspended.
       ``(iii) The Secretary may reinstate the registration, 
     whether suspended under clause (i) or (ii), if the Secretary 
     determines that the registered exporter has demonstrated that 
     further violations of registration conditions will not occur.
       ``(B) Termination.--The Secretary, after notice and 
     opportunity for a hearing, may terminate the registration 
     under subsection (f) of a registered exporter if the 
     Secretary determines that the registered exporter has engaged 
     in a pattern or practice of violating 1 or more registration 
     conditions, or if on 1 or more occasions the Secretary has 
     under subparagraph (A)(ii) suspended the registration of the 
     registered exporter. The Secretary may make the termination 
     permanent, or for a fixed period of not less than 1 year. 
     During the period in which the registration of a registered 
     exporter is terminated, any registration submitted under 
     subsection (f) by such exporter or a person who is a partner 
     in the export enterprise or a principal officer in such 
     enterprise, and any registration prepared with the assistance 
     of such exporter or such a person, has no legal effect under 
     this section.''.

     SEC. 10009. AUTHORIZATION OF APPROPRIATIONS.

       There are authorized to be appropriated such sums as may be 
     necessary to carry out this title (and the amendments made by 
     this title).
                                 ______
                                 
  SA 2864. Mr. VITTER submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 156, line 4, strike all through page 157, line 7, 
     and insert the following:
       (D) Requirement of members of congress to enroll in the 
     public option.--
       (i) Requirement.--Notwithstanding any other provision of 
     law, all Members of Congress shall be enrolled in the 
     community health insurance option when established by the 
     Secretary.
       (ii) Ineligible for fehbp.--Effective on the date on which 
     the community health insurance option is established by the 
     Secretary, no Member of Congress shall be eligible to 
     participate in a health benefits plan under chapter 89 of 
     title 5, United States Code.
       (iii) Employer contribution.--

       (I) In general.--The Secretary of the Senate or the Chief 
     Administrative Officer of the House of Representatives shall 
     pay the amount determined under subclause (II) to--

       (aa) the appropriate community health insurance option; or
       (bb) in the case of a Member of Congress who resides in a 
     State which opts out of providing a community health 
     insurance option and is enrolled in a plan offered through an 
     Exchange, the appropriate Exchange.

       (II) Amount of employer contribution.--The Director of the 
     Office of Personnel Management shall determine the amount of 
     the employer contribution for each Member of Congress 
     enrolled in a community health insurance option. The amount 
     shall be equal to the employer contribution for the health 
     benefits plan under chapter 89 of title 5, United States 
     Code, with the greatest number of enrollees, except that the 
     contribution shall be actuarially adjusted for age.

       (iv) Military medical treatment facilities and the office 
     of the attending physician.--

       (I) In general.--Notwithstanding any other provision of 
     law, a Member of Congress may not receive health care or 
     medical treatment at any military medical treatment facility 
     or at the Office of the Attending Physician.
       (II) Exception.--Subclause (I) shall not apply to any case 
     of a medical emergency in which the life of a Member of 
     Congress is in immediate danger.

       (v) Definitions.--In this subparagraph:

       (I) Community health insurance option.--The term 
     ``community health insurance option'' means the health 
     insurance established by the Secretary under section 1323.
       (II) Member of congress.--The term ``Member of Congress'' 
     means any member of the House of Representatives or the 
     Senate.

                                 ______
                                 
  SA 2865. Mr. BURRIS submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 1249 between lines 6 and 7, insert the following:
       (b) Hospital Compare Patient Surveys.--
       (1) In general.--In implementing the Hospital Compare 
     patient survey program, the Director of the Agency for 
     Healthcare Research and Quality shall, in addition to 
     collecting other information to reduce health disparities, 
     collect information concerning--
       (A) whether hospital staff effectively address cultural and 
     linguistic barriers that may prevent patients from receiving 
     quality health care; and
       (B) whether hospital health promotion programs are 
     effectively marketed in the community served by the hospital.
       (2) Requirement to take into account survey in community 
     health needs assessments.--Section 501(r)(3)(B) of the 
     Internal

[[Page 29377]]

     Revenue Code of 1986, as added by section 9007, is amended 
     striking ``and'' at the end of clause (i), by redesignating 
     clause (ii) as clause (iii), and by inserting after clause 
     (i) the following new clause:
       ``(ii) takes into account the information collected under 
     the Hospital Compare patient survey program, and''.
                                 ______
                                 
  SA 2866. Mr. SPECTER submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end of subtitle D of title IV, insert the following:

     SEC. 4307. CURES ACCELERATION NETWORK.

       (a) Short Title.--This section may be cited as the ``Cures 
     Acceleration Network Act of 2009''.
       (b) Requirement for the Director of NIH to Establish a 
     Cures Acceleration Network.--Section 402(b) of the Public 
     Health Service Act (42 U.S.C. 282(b)) is amended--
       (1) in paragraph (22), by striking ``and'' at the end;
       (2) in paragraph (23), by striking the period and inserting 
     ``; and''; and
       (3) by inserting after paragraph (23), the following:
       ``(24) implement the Cures Acceleration Network described 
     in section 402C.''.
       (c) Accepting Gifts to Support the Cures Acceleration 
     Network.--Section 499(c)(1) of the Public Health Service Act 
     (42 U.S.C. 290b(c)(1)) is amended by adding at the end the 
     following:
       ``(E) The Cures Acceleration Network described in section 
     402C.''.
       (d) Establishment of the Cures Acceleration Network.--Part 
     A of title IV of the Public Health Service Act is amended by 
     inserting after section 402B (42 U.S.C. 282b) the following:

     ``SEC. 402C. CURES ACCELERATION NETWORK.

       ``(a) Definitions.--In this section:
       ``(1) Biological product.--The term `biological product' 
     has the meaning given such term in section 351 of the Public 
     Health Service Act.
       ``(2) Drug; device.--The terms `drug' and `device' have the 
     meanings given such terms in section 201 of the Federal Food, 
     Drug, and Cosmetic Act.
       ``(3) High need cure.--The term `high need cure' means a 
     drug (as that term is defined by section 201(g)(1) of the 
     Federal Food, Drug, and Cosmetic Act, biological product (as 
     that term is defined by section 262(i)), or device (as that 
     term is defined by section 201(h) of the Federal Food, Drug, 
     and Cosmetic Act) that, in the determination of the Director 
     of NIH--
       ``(A) is a priority to diagnose, mitigate, prevent, or 
     treat harm from any disease or condition; and
       ``(B) for which the incentives of the commercial market are 
     unlikely to result in its adequate or timely development.
       ``(4) Medical product.--The term `medical product' means a 
     drug, device, biological product, or product that is a 
     combination of drugs, devices, and biological products.
       ``(b) Establishment of the Cures Acceleration Network.--
     Subject to the appropriation of funds as described in 
     subsection (g), there is established within the Office of the 
     Director of NIH a program to be known as the Cures 
     Acceleration Network (referred to in this section as `CAN'), 
     which shall--
       ``(1) be under the direction of the Director of NIH, taking 
     into account the recommendations of a CAN Review Board 
     (referred to in this section as the `Board'), described in 
     subsection (d); and
       ``(2) award grants and contracts to eligible entities, as 
     described in subsection (e), to accelerate the development of 
     high need cures, including through the development of medical 
     products and behavioral therapies.
       ``(c) Functions.--The functions of the CAN are to--
       ``(1) conduct and support revolutionary advances in basic 
     research, translating scientific discoveries from bench to 
     bedside;
       ``(2) award grants and contracts to eligible entities to 
     accelerate the development of high need cures;
       ``(3) provide the resources necessary for government 
     agencies, independent investigators, research organizations, 
     biotechnology companies, academic research institutions, and 
     other entities to develop high need cures;
       ``(4) reduce the barriers between laboratory discoveries 
     and clinical trials for new therapies; and
       ``(5) facilitate review in the Food and Drug Administration 
     for the high need cures funded by the CAN, through activities 
     that may include--
       ``(A) the facilitation of regular and ongoing communication 
     with the Food and Drug Administration regarding the status of 
     activities conducted under this section;
       ``(B) ensuring that such activities are coordinated with 
     the approval requirements of the Food and Drug 
     Administration, with the goal of expediting the development 
     and approval of countermeasures and products; and
       ``(C) connecting interested persons with additional 
     technical assistance made available under section 565 of the 
     Federal Food, Drug, and Cosmetic Act.
       ``(d) CAN Board.--
       ``(1) Establishment.--There is established a Cures 
     Acceleration Network Review Board (referred to in this 
     section as the `Board'), which shall advise the Director of 
     NIH on the conduct of the activities of the Cures 
     Acceleration Network.
       ``(2) Membership.--
       ``(A) In general.--
       ``(i) Appointment.--The Board shall be comprised of 24 
     members who are appointed by the Secretary and who serve at 
     the pleasure of the Secretary.
       ``(ii) Chairperson and vice chairperson.--The Secretary 
     shall designate, from among the 24 members appointed under 
     clause (i), one Chairperson of the Board (referred to in this 
     section as the `Chairperson') and one Vice Chairperson.
       ``(B) Terms.--
       ``(i) In general.--Each member shall be appointed to serve 
     a 4-year term, except that any member appointed to fill a 
     vacancy occurring prior to the expiration of the term for 
     which the member's predecessor was appointed shall be 
     appointed for the remainder of such term.
       ``(ii) Consecutive appointments; maximum terms.--A member 
     may be appointed to serve not more than 3 terms on the Board, 
     and may not serve more than 2 such terms consecutively.
       ``(C) Qualifications.--
       ``(i) In general.--The Secretary shall appoint individuals 
     to the Board based solely upon the individual's established 
     record of distinguished service in one of the areas of 
     expertise described in clause (ii). Each individual appointed 
     to the Board shall be of distinguished achievement and have a 
     broad range of disciplinary interests.
       ``(ii) Expertise.--The Secretary shall select individuals 
     based upon the following requirements:

       ``(I) For each of the fields of--

       ``(aa) basic research;
       ``(bb) medicine;
       ``(cc) biopharmaceuticals;
       ``(dd) discovery and delivery of medical products;
       ``(ee) bioinformatics and gene therapy;
       ``(ff) medical instrumentation; and
       ``(gg) regulatory review and approval of medical products,

     the Secretary shall select at least 1 individual who is 
     eminent in such fields.
       ``(II) At least 4 individuals shall be recognized leaders 
     in professional venture capital or private equity 
     organizations and have demonstrated experience in private 
     equity investing.
       ``(III) At least 8 individuals shall represent disease 
     advocacy organizations.

       ``(3) Ex-officio members.--
       ``(A) Appointment.--In addition to the 24 Board members 
     described in paragraph (2), the Secretary shall appoint as 
     ex-officio members of the Board--
       ``(i) a representative of the National Institutes of 
     Health, recommended by the Secretary of the Department of 
     Health and Human Services;
       ``(ii) a representative of the Office of the Assistant 
     Secretary of Defense for Health Affairs, recommended by the 
     Secretary of Defense;
       ``(iii) a representative of the Office of the Under 
     Secretary for Health for the Veterans Health Administration, 
     recommended by the Secretary of Veterans Affairs;
       ``(iv) a representative of the National Science Foundation, 
     recommended by the Chair of the National Science Board; and
       ``(v) a representative of the Food and Drug Administration, 
     recommended by the Commissioner of Food and Drugs.
       ``(B) Terms.--Each ex-officio member shall serve a 3-year 
     term on the Board, except that the Chairperson may adjust the 
     terms of the initial ex-officio members in order to provide 
     for a staggered term of appointment for all such members.
       ``(4) Responsibilities of the board and the director of 
     nih.--
       ``(A) Responsibilities of the board.--
       ``(i) In general.--The Board shall advise, and provide 
     recommendations to, the Director of NIH with respect to--

       ``(I) policies, programs, and procedures for carrying out 
     the duties of the Director of NIH under this section; and
       ``(II) significant barriers to successful translation of 
     basic science into clinical application (including issues 
     under the purview of other agencies and departments).

       ``(ii) Report.--In the case that the Board identifies a 
     significant barrier, as described in clause (i)(II), the 
     Board shall submit to the Secretary a report regarding such 
     barrier.
       ``(B) Responsibilities of the director of nih.--With 
     respect to each recommendation provided by the Board under 
     subparagraph (A)(i), the Director of NIH shall respond in 
     writing to the Board, indicating whether such Director will 
     implement such recommendation. In the case that the Director 
     of NIH indicates a recommendation of the

[[Page 29378]]

     Board will not be implemented, such Director shall provide an 
     explanation of the reasons for not implementing such 
     recommendation.
       ``(5) Meetings.--
       ``(A) In general.--The Board shall meet 4 times per 
     calendar year, at the call of the Chairperson.
       ``(B) Quorum; requirements; limitations.--
       ``(i) Quorum.--A quorum shall consist of a total of 13 
     members of the Board, excluding ex-officio members, with 
     diverse representation as described in clause (iii).
       ``(ii) Chairperson or vice chairperson.--Each meeting of 
     the Board shall be attended by either the Chairperson or the 
     Vice Chairperson.
       ``(iii) Diverse representation.--At each meeting of the 
     Board, there shall be not less than one scientist, one 
     representative of a disease advocacy organization, and one 
     representative of a professional venture capital or private 
     equity organization.
       ``(6) Compensation and travel expenses.--
       ``(A) Compensation.--Members shall receive compensation at 
     a rate to be fixed by the Chairperson but not to exceed a 
     rate equal to the daily equivalent of the annual rate of 
     basic pay prescribed for level IV of the Executive Schedule 
     under section 5315 of title 5, United States Code, for each 
     day (including travel time) during which the member is 
     engaged in the performance of the duties of the Board. All 
     members of the Board who are officers or employees of the 
     Untied States shall serve without compensation in addition to 
     that received for their services as officers or employees of 
     the United States.
       ``(B) Travel expenses.--Members of the Board shall be 
     allowed travel expenses, including per diem in lieu of 
     subsistence, at rates authorized for persons employed 
     intermittently by the Federal Government under section 
     5703(b) of title 5, United States Code, while away from their 
     homes or regular places of business in the performance of 
     services for the Board.
       ``(e) Grant Program.--
       ``(1) Supporting innovation.--To carry out the purposes 
     described in this section, the Director of NIH shall award 
     contracts, grants, or cooperative agreements to the entities 
     described in paragraph (2), to--
       ``(A) promote innovation in technologies supporting the 
     advanced research and development and production of high need 
     cures, including through the development of medical products 
     and behavioral therapies;
       ``(B) accelerate the development of high need cures, 
     including through the development of medical products, 
     behavioral therapies, and biomarkers that demonstrate the 
     safety or effectiveness of medical products; or
       ``(C) help the award recipient establish protocols that 
     comply with Food and Drug Administration standards and 
     otherwise permit the recipient to meet regulatory 
     requirements at all stages of development, manufacturing, 
     review, approval, and safety surveillance of a medical 
     product.
       ``(2) Eligible entities.--To receive assistance under 
     paragraph (1), an entity shall--
       ``(A) be a public or private entity, which may include a 
     private or public research institution, an institution of 
     higher education, a medical center, a biotechnology company, 
     a pharmaceutical company, a disease advocacy organization, a 
     patient advocacy organization, or an academic research 
     institution;
       ``(B) submit an application containing--
       ``(i) a detailed description of the project for which the 
     entity seeks such grant or contract;
       ``(ii) a timetable for such project;
       ``(iii) an assurance that the entity will submit--

       ``(I) interim reports describing the entity's--

       ``(aa) progress in carrying out the project; and
       ``(bb) compliance with all provisions of this section and 
     conditions of receipt of such grant or contract; and

       ``(II) a final report at the conclusion of the grant 
     period, describing the outcomes of the project; and

       ``(iv) a description of the protocols the entity will 
     follow to comply with Food and Drug Administration standards 
     and regulatory requirements at all stages of development, 
     manufacturing, review, approval, and safety surveillance of a 
     medical product; and
       ``(C) provide such additional information as the Director 
     of NIH may require.
       ``(3) Awards.--
       ``(A) The cures acceleration partnership awards.--
       ``(i) Initial award amount.--Each award under this 
     subparagraph shall be not more than $15,000,000 per project 
     for the first fiscal year for which the project is funded, 
     which shall be payable in one payment.
       ``(ii) Funding in subsequent fiscal years.--An eligible 
     entity receiving an award under clause (i) may apply for 
     additional funding for such project by submitting to the 
     Director of NIH the information required under subparagraphs 
     (B) and (C) of paragraph (2). The Director may fund a project 
     of such eligible entity in an amount not to exceed 
     $15,000,000 for a fiscal year subsequent to the initial award 
     under clause (i).
       ``(iii) Matching funds.--As a condition for receiving an 
     award under this subsection, an eligible entity shall 
     contribute to the project non-Federal funds in the amount of 
     $1 for every $3 awarded under clauses (i) and (ii), except 
     that the Director of NIH may waive or modify such matching 
     requirement in any case where the Director determines that 
     the goals and objectives of this section cannot adequately be 
     carried out unless such requirement is waived.
       ``(B) The cures acceleration grant awards.--
       ``(i) Initial award amount.--Each award under this 
     subparagraph shall be not more than $15,000,000 per project 
     for the first fiscal year for which the project is funded, 
     which shall be payable in one payment.
       ``(ii) Funding in subsequent fiscal years.--An eligible 
     entity receiving an award under clause (i) may apply for 
     additional funding for such project by submitting to the 
     Board the information required under subparagraphs (B) and 
     (C) of paragraph (2). The Director of NIH may fund a project 
     of such eligible entity in an amount not to exceed 
     $15,000,000 for a fiscal year subsequent to the initial award 
     under clause (i).
       ``(C) The cures acceleration flexible research awards.--If 
     the Director of NIH determines that the goals and objectives 
     of this section cannot adequately be carried out through a 
     contract, grant, or cooperative agreement, the Director of 
     NIH shall have flexible research authority to use other 
     transactions to fund projects in accordance with the terms 
     and conditions of this section. Awards made under such 
     flexible research authority for a fiscal year shall not 
     exceed 20 percent of the total funds appropriated under 
     subsection (g)(1) for such fiscal year.
       ``(4) Suspension of awards for defaults, noncompliance with 
     provisions and plans, and diversion of funds; repayment of 
     funds.--The Director of NIH may suspend the award to any 
     entity upon noncompliance by such entity with provisions and 
     plans under this section or diversion of funds.
       ``(5) Audits.--The Director of NIH may enter into 
     agreements with other entities to conduct periodic audits of 
     the projects funded by grants or contracts awarded under this 
     subsection.
       ``(6) Closeout procedures.--At the end of a grant or 
     contract period, a recipient shall follow the closeout 
     procedures under section 74.71 of title 45, Code of Federal 
     Regulations (or any successor regulation).
       ``(7) Review.--A determination by the Director of NIH as to 
     whether a drug, device, or biological product is a high need 
     cure (for purposes of subsection (a)(3)) shall not be subject 
     to judicial review.
       ``(f) Competitive Basis of Awards.--Any grant, cooperative 
     agreement, or contract awarded under this section shall be 
     awarded on a competitive basis.
       ``(g) Authorization of Appropriations.--
       ``(1) In general.--For purposes of carrying out this 
     section, there are authorized to be appropriated $500,000,000 
     for fiscal year 2010, and such sums as may be necessary for 
     subsequent fiscal years. Funds appropriated under this 
     section shall be available until expended.
       ``(2) Limitation on use of funds otherwise appropriated.--
     No funds appropriated under this Act, other than funds 
     appropriated under paragraph (1), may be allocated to the 
     Cures Acceleration Network.''.
                                 ______
                                 
  SA 2867. Mr. SPECTER submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

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

     SEC. __. INCREASE IN FUNDING FOR THE NATIONAL INSTITUTES OF 
                   HEALTH.

       (a) Authorization of Appropriations.--Section 402A(a) of 
     the Public Health Service Act (42 U.S.C. 282a(a)) is amended 
     by striking paragraphs (1) through (3) and inserting the 
     following:
       ``(1) $40,000,000,000 for fiscal year 2010; and
       ``(2) such sums as may be necessary for each of fiscal 
     years 2011 and 2012.''.
       (b) Office of the Director.--Section 402A(b) of the Public 
     Health Service Act (42 U.S.C. 282a(b)) is amended by striking 
     ``2007 through 2009'' and inserting ``2010 through 2012''.
                                 ______
                                 
  SA 2868. Mr. BURRIS submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:


[[Page 29379]]

       On page 147, line 19, strike ``and''.
       On page 147, line 21, strike the period and insert ``; 
     and''.
       On page 147, between lines 21 and 22, insert the following:
       ``(E) the implementation of activities that reduce health 
     care disparities, including through the use of language 
     services, community outreach, and cultural competency 
     training.''.
                                 ______
                                 
  SA 2869. Mr. NELSON of Florida (for himself, Mr. Rockefeller, Mr. 
Begich, Mr. Leahy, Mr. Brown, Ms. Stabenow, and Mrs. Shaheen) submitted 
an amendment intended to be proposed to amendment SA 2786 proposed by 
Mr. Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the 
bill H.R. 3590, to amend the Internal Revenue Code of 1986 to modify 
the first-time homebuyers credit in the case of members of the Armed 
Forces and certain other Federal employees, and for other purposes; 
which was ordered to lie on the table; as follows:

       On page 974, between lines 9 and 10, insert the following:
       (b) Elimination of Coverage Gap.--Section 1860D-2(b) of the 
     Social Security Act (42 U.S.C. 1395w-102(b)) is further 
     amended--
       (1) in paragraph (3)(A), by striking ``and (7)'' and 
     inserting ``, (7), and (8)'';
       (2) in paragraph (4)(B)(i), by inserting ``subject to 
     paragraph (8)'' after ``purposes of this part''; and
       (3) by adding at the end the following new paragraph:
       ``(8) Phased-in elimination of coverage gap.--
       ``(A) In general.--For each year beginning with 2011, the 
     Secretary shall consistent with this paragraph progressively 
     increase the initial coverage limit (described in subsection 
     (b)(3)) and decrease the annual out-of-pocket threshold from 
     the amounts otherwise computed until there is a continuation 
     of coverage from the initial coverage limit for expenditures 
     incurred through the total amount of expenditures at which 
     benefits are available under paragraph (4).
       ``(B) Increase in initial coverage limit.--For a year 
     beginning with 2011, the initial coverage limit otherwise 
     computed without regard to this paragraph shall be increased 
     by \1/2\ of the cumulative phase-in percentage (as defined in 
     subparagraph (D)(ii) for the year) times the out-of-pocket 
     gap amount (as defined in subparagraph (E)) for the year.
       ``(C) Decrease in annual out-of-pocket threshold.--For a 
     year beginning with 2011, the annual out-of-pocket threshold 
     otherwise computed without regard to this paragraph shall be 
     decreased by \1/2\ of the cumulative phase-in percentage of 
     the out-of-pocket gap amount for the year multiplied by 1.75.
       ``(D) Phase-in.--For purposes of this paragraph:
       ``(i) Annual phase-in percentage.--The term `annual phase-
     in percentage' means--

       ``(I) for 2011, 13 percent;
       ``(II) for 2012, 2013, 2014, and 2015, 5 percent;
       ``(III) for 2016 through 2018, 7.5 percent; and
       ``(IV) for 2019 and each subsequent year, 10 percent.

       ``(ii) Cumulative phase-in percentage.--The term 
     `cumulative phase-in percentage' means for a year the sum of 
     the annual phase-in percentage for the year and the annual 
     phase-in percentages for each previous year beginning with 
     2011, but in no case more than 100 percent.
       ``(E) Out-of-pocket gap amount.--For purposes of this 
     paragraph, the term `out-of-pocket gap amount' means for a 
     year the amount by which--
       ``(i) the annual out-of-pocket threshold specified in 
     paragraph (4)(B) for the year (as determined as if this 
     paragraph did not apply), exceeds
       ``(ii) the sum of--

       ``(I) the annual deductible under paragraph (1) for the 
     year; and
       ``(II) \1/4\ of the amount by which the initial coverage 
     limit under paragraph (3) for the year (as determined as if 
     this paragraph did not apply) exceeds such annual 
     deductible.''.

       (c) Requiring Drug Manufacturers To Provide Drug Rebates 
     for Full-Benefit Dual Eligibles.--
       (1) In general.--Section 1860D-2 of the Social Security Act 
     (42 U.S.C. 1396r-8) is amended--
       (A) in subsection (e)(1), in the matter before subparagraph 
     (A), by inserting ``and subsection (f)'' after ``this 
     subsection''; and
       (B) by adding at the end the following new subsection:
       ``(f) Prescription Drug Rebate Agreement for Full-Benefit 
     Dual Eligible Individuals.--
       ``(1) In general.--In this part, the term `covered part D 
     drug' does not include any drug or biologic that is 
     manufactured by a manufacturer that has not entered into and 
     have in effect a rebate agreement described in paragraph (2).
       ``(2) Rebate agreement.--A rebate agreement under this 
     subsection shall require the manufacturer to provide to the 
     Secretary a rebate for each rebate period (as defined in 
     paragraph (6)(B)) ending after December 31, 2010, in the 
     amount specified in paragraph (3) for any covered part D drug 
     of the manufacturer dispensed after December 31, 2010, to any 
     full-benefit dual eligible individual (as defined in 
     paragraph (6)(A)) for which payment was made by a PDP sponsor 
     under part D or a MA organization under part C for such 
     period. Such rebate shall be paid by the manufacturer to the 
     Secretary not later than 30 days after the date of receipt of 
     the information described in section 1860D-12(b)(7), 
     including as such section is applied under section 
     1857(f)(3).
       ``(3) Rebate for full-benefit dual eligible medicare drug 
     plan enrollees.--
       ``(A) In general.--The amount of the rebate specified under 
     this paragraph for a manufacturer for a rebate period, with 
     respect to each dosage form and strength of any covered part 
     D drug provided by such manufacturer and dispensed to a full-
     benefit dual eligible individual, shall be equal to the 
     product of--
       ``(i) the total number of units of such dosage form and 
     strength of the drug so provided and dispensed for which 
     payment was made by a PDP sponsor under part D or a MA 
     organization under part C for the rebate period (as reported 
     under section 1860D-12(b)(7), including as such section is 
     applied under section 1857(f)(3)); and
       ``(ii) the amount (if any) by which--

       ``(I) the Medicaid rebate amount (as defined in 
     subparagraph (B)) for such form, strength, and period, 
     exceeds
       ``(II) the average Medicare drug program full-benefit dual 
     eligible rebate amount (as defined in subparagraph (C)) for 
     such form, strength, and period.

       ``(B) Medicaid rebate amount.--For purposes of this 
     paragraph, the term `Medicaid rebate amount' means, with 
     respect to each dosage form and strength of a covered part D 
     drug provided by the manufacturer for a rebate period--
       ``(i) in the case of a single source drug or an innovator 
     multiple source drug, the amount specified in paragraph 
     (1)(A)(ii) of section 1927(b) plus the amount, if any, 
     specified in paragraph (2)(A)(ii) of such section, for such 
     form, strength, and period; or
       ``(ii) in the case of any other covered outpatient drug, 
     the amount specified in paragraph (3)(A)(i) of such section 
     for such form, strength, and period.
       ``(C) Average medicare drug program full-benefit dual 
     eligible rebate amount.--For purposes of this subsection, the 
     term `average Medicare drug program full-benefit dual 
     eligible rebate amount' means, with respect to each dosage 
     form and strength of a covered part D drug provided by a 
     manufacturer for a rebate period, the sum, for all PDP 
     sponsors under part D and MA organizations administering a 
     MA-PD plan under part C, of--
       ``(i) the product, for each such sponsor or organization, 
     of--

       ``(I) the sum of all rebates, discounts, or other price 
     concessions (not taking into account any rebate provided 
     under paragraph (2) for such dosage form and strength of the 
     drug dispensed, calculated on a per-unit basis, but only to 
     the extent that any such rebate, discount, or other price 
     concession applies equally to drugs dispensed to full-benefit 
     dual eligible Medicare drug plan enrollees and drugs 
     dispensed to PDP and MA-PD enrollees who are not full-benefit 
     dual eligible individuals; and
       ``(II) the number of the units of such dosage and strength 
     of the drug dispensed during the rebate period to full-
     benefit dual eligible individuals enrolled in the 
     prescription drug plans administered by the PDP sponsor or 
     the MA-PD plans administered by the MA-PD organization; 
     divided by

       ``(ii) the total number of units of such dosage and 
     strength of the drug dispensed during the rebate period to 
     full-benefit dual eligible individuals enrolled in all 
     prescription drug plans administered by PDP sponsors and all 
     MA-PD plans administered by MA-PD organizations.
       ``(4) Length of agreement.--The provisions of paragraph (4) 
     of section 1927(b) (other than clauses (iv) and (v) of 
     subparagraph (B)) shall apply to rebate agreements under this 
     subsection in the same manner as such paragraph applies to a 
     rebate agreement under such section.
       ``(5) Other terms and conditions.--The Secretary shall 
     establish other terms and conditions of the rebate agreement 
     under this subsection, including terms and conditions related 
     to compliance, that are consistent with this subsection.
       ``(6) Definitions.--In this subsection and section 1860D-
     12(b)(7):
       ``(A) Full-benefit dual eligible individual.--The term 
     `full-benefit dual eligible individual' has the meaning given 
     such term in section 1935(c)(6).
       ``(B) Rebate period.--The term `rebate period' has the 
     meaning given such term in section 1927(k)(8).''.
       (2) Reporting requirement for the determination and payment 
     of rebates by manufactures related to rebate for full-benefit 
     dual eligible medicare drug plan enrollees.--
       (A) Requirements for pdp sponsors.--Section 1860D-12(b) of 
     the Social Security Act (42 U.S.C. 1395w-112(b)) is amended 
     by adding at the end the following new paragraph:
       ``(7) Reporting requirement for the determination and 
     payment of rebates by manufacturers related to rebate for

[[Page 29380]]

     full-benefit dual eligible medicare drug plan enrollees.--
       ``(A) In general.--For purposes of the rebate under section 
     1860D-2(f) for contract years beginning on or after January 
     1, 2011, each contract entered into with a PDP sponsor under 
     this part with respect to a prescription drug plan shall 
     require that the sponsor comply with subparagraphs (B) and 
     (C).
       ``(B) Report form and contents.--Not later than 60 days 
     after the end of each rebate period (as defined in section 
     1860D-2(f)(6)(B)) within such a contract year to which such 
     section applies, a PDP sponsor of a prescription drug plan 
     under this part shall report to each manufacturer--
       ``(i) information (by National Drug Code number) on the 
     total number of units of each dosage, form, and strength of 
     each drug of such manufacturer dispensed to full-benefit dual 
     eligible Medicare drug plan enrollees under any prescription 
     drug plan operated by the PDP sponsor during the rebate 
     period;
       ``(ii) information on the price discounts, price 
     concessions, and rebates for such drugs for such form, 
     strength, and period;
       ``(iii) information on the extent to which such price 
     discounts, price concessions, and rebates apply equally to 
     full-benefit dual eligible Medicare drug plan enrollees and 
     PDP enrollees who are not full-benefit dual eligible Medicare 
     drug plan enrollees; and
       ``(iv) any additional information that the Secretary 
     determines is necessary to enable the Secretary to calculate 
     the average Medicare drug program full-benefit dual eligible 
     rebate amount (as defined in paragraph (3)(C) of such 
     section), and to determine the amount of the rebate required 
     under this section, for such form, strength, and period.
     Such report shall be in a form consistent with a standard 
     reporting format established by the Secretary.
       ``(C) Submission to secretary.--Each PDP sponsor shall 
     promptly transmit a copy of the information reported under 
     subparagraph (B) to the Secretary for the purpose of audit 
     oversight and evaluation.
       ``(D) Confidentiality of information.--The provisions of 
     subparagraph (D) of section 1927(b)(3), relating to 
     confidentiality of information, shall apply to information 
     reported by PDP sponsors under this paragraph in the same 
     manner that such provisions apply to information disclosed by 
     manufacturers or wholesalers under such section, except--
       ``(i) that any reference to `this section' in clause (i) of 
     such subparagraph shall be treated as being a reference to 
     this section;
       ``(ii) the reference to the Director of the Congressional 
     Budget Office in clause (iii) of such subparagraph shall be 
     treated as including a reference to the Medicare Payment 
     Advisory Commission; and
       ``(iii) clause (iv) of such subparagraph shall not apply.
       ``(E) Oversight.--Information reported under this paragraph 
     may be used by the Inspector General of the Department of 
     Health and Human Services for the statutorily authorized 
     purposes of audit, investigation, and evaluations.
       ``(F) Penalties for failure to provide timely information 
     and provision of false information.--In the case of a PDP 
     sponsor--
       ``(i) that fails to provide information required under 
     subparagraph (B) on a timely basis, the sponsor is subject to 
     a civil money penalty in the amount of $10,000 for each day 
     in which such information has not been provided; or
       ``(ii) that knowingly (as defined in section 1128A(i)) 
     provides false information under such subparagraph, the 
     sponsor is subject to a civil money penalty in an amount not 
     to exceed $100,000 for each item of false information.
     Such civil money penalties are in addition to other penalties 
     as may be prescribed by law. The provisions of section 1128A 
     (other than subsections (a) and (b)) shall apply to a civil 
     money penalty under this subparagraph in the same manner as 
     such provisions apply to a penalty or proceeding under 
     section 1128A(a).''.
       (B) Application to ma organizations.--Section 1857(f)(3) of 
     the Social Security Act (42 U.S.C. 1395w-27(f)(3)) is amended 
     by adding at the end the following:
       ``(D) Reporting requirement related to rebate for full-
     benefit dual eligible medicare drug plan enrollees.--Section 
     1860D-12(b)(7).''.
       (3) Deposit of rebates into medicare prescription drug 
     account.--Section 1860D-16(c) of such Act (42 U.S.C. 1395w-
     116(c)) is amended by adding at the end the following new 
     paragraph:
       ``(6) Rebate for full-benefit dual eligible medicare drug 
     plan enrollees.--Amounts paid under a rebate agreement under 
     section 1860D-2(f) shall be deposited into the Account and 
     shall be used to pay for all or part of the gradual 
     elimination of the coverage gap under section 1860D-
     2(b)(7).''.
       (d) Sunset of Medicare Coverage Gap Discount Program.--
     Section 3301 of this Act is amended by adding at the end the 
     following new subsection:
       ``(e) Sunset of Medicare Coverage Gap Discount Program.--
     The amendments made by this section shall cease to be 
     effective as of the date on which there is a continuation of 
     coverage from the initial coverage limit for expenditures 
     incurred through the total amount of expenditures at which 
     benefits are available under section 1860D-2(b)(4).''.
                                 ______
                                 
  SA 2870. Mr. WHITEHOUSE proposed an amendment to amendment SA 2786 
proposed by Mr. Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. 
Harkin) to the bill H.R. 3590, to amend the Internal Revenue Code of 
1986 to modify the first-time homebuyers credit in the case of members 
of the Armed Forces and certain other Federal employees, and for other 
purposes; as follows:

       At the appropriate place, insert the following:

     SEC. __. SENSE OF THE SENATE PROMOTING FISCAL RESPONSIBILITY.

       (a) Findings.--The Senate makes the following findings:
       (1) Based on Congressional Budget Office (CBO) estimates, 
     this Act will reduce the Federal deficit between 2010 and 
     2019.
       (2) CBO projects this Act will continue to reduce budget 
     deficits after 2019.
       (3) Based on CBO estimates, this Act will extend the 
     solvency of the Medicare HI Trust Fund.
       (4) This Act will increase the surplus in the Social 
     Security Trust Fund, which should be reserved to strengthen 
     the finances of Social Security.
       (5) The initial net savings generated by the Community 
     Living Assistance Services and Supports (CLASS) program are 
     necessary to ensure the long-term solvency of that program.
       (b) Sense of the Senate.--It is the sense of the Senate 
     that--
       (1) the additional surplus in the Social Security Trust 
     Fund generated by this Act should be reserved for Social 
     Security and not spent in this Act for other purposes; and
       (2) the net savings generated by the CLASS program should 
     be reserved for the CLASS program and not spent in this Act 
     for other purposes.
                                 ______
                                 
  SA 2871. Mr. BROWN (for himself and Mrs. Hutchison) submitted an 
amendment intended to be proposed to amendment SA 2786 proposed by Mr. 
Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the bill 
H.R. 3590, to amend the Internal Revenue Code of 1986 to modify the 
first-time homebuyers credit in the case of members of the Armed Forces 
and certain other Federal employees, and for other purposes; which was 
ordered to lie on the table; as follows:

       On page 97, between lines 6 and 7, insert the following:

     ``SEC. 2710. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 
                   APPROVED CLINICAL TRIALS.

       ``(a) Coverage.--
       ``(1) In general.--If a group health plan or a health 
     insurance issuer offering group or individual health 
     insurance coverage provides coverage to a qualified 
     individual, then such plan or issuer--
       ``(A) may not deny the individual participation in the 
     clinical trial referred to in subsection (b)(2);
       ``(B) subject to subsection (c), may not deny (or limit or 
     impose additional conditions on) the coverage of routine 
     patient costs; and
       ``(C) may not discriminate against the individual on the 
     basis of the individual's participation in such trial.
       ``(2) Routine patient costs.--
       ``(A) Inclusion.--For purposes of paragraph (1)(B), subject 
     to subparagraph (B), routine patient costs include all items 
     and services consistent with the coverage provided in the 
     plan (or coverage) that is typically covered for a qualified 
     individual who is not enrolled in a clinical trial.
       ``(B) Exclusion.--For purposes of paragraph (1)(B), routine 
     patient costs does not include--
       ``(i) the investigational item, device, or service, itself;
       ``(ii) items and services that are provided solely to 
     satisfy data collection and analysis needs and that are not 
     used in the direct clinical management of the patient; or
       ``(iii) a service that is clearly inconsistent with widely 
     accepted and established standards of care for a particular 
     diagnosis.
       ``(3) Use of in-network providers.--If one or more 
     participating providers is participating in a clinical trial, 
     nothing in paragraph (1) shall be construed as preventing a 
     plan or issuer from requiring that a qualified individual 
     participate in the trial through such a participating 
     provider if the provider will accept the individual as a 
     participant in the trial.
       ``(4) Use of out-of-network.--Notwithstanding paragraph 
     (3), paragraph (1) shall apply to a qualified individual 
     participating in an approved clinical trial that is conducted 
     outside the State in which the qualified individual resides.
       ``(b) Qualified Individual Defined.--For purposes of 
     subsection (a), the term `qualified individual' means an 
     individual who is a participant or beneficiary in a health 
     plan or with coverage described in subsection (a)(1) and who 
     meets the following conditions:
       ``(1) The individual is eligible to participate in an 
     approved clinical trial according

[[Page 29381]]

     to the trial protocol with respect to treatment of cancer or 
     other life-threatening disease or condition.
       ``(2) Either--
       ``(A) the referring health care professional is a 
     participating health care provider and has concluded that the 
     individual's participation in such trial would be appropriate 
     based upon the individual meeting the conditions described in 
     paragraph (1); or
       ``(B) the participant or beneficiary provides medical and 
     scientific information establishing that the individual's 
     participation in such trial would be appropriate based upon 
     the individual meeting the conditions described in paragraph 
     (1).
       ``(c) Limitations on Coverage.--This section shall not be 
     construed to require a group health plan, or a health 
     insurance issuer offering group or individual health 
     insurance coverage, to provide benefits for routine patient 
     care services provided outside of the plan's (or coverage's) 
     health care provider network unless out-of-network benefits 
     are otherwise provided under the plan (or coverage).
       ``(d) Approved Clinical Trial Defined.--
       ``(1) In general.--In this section, the term `approved 
     clinical trial' means a clinical trial (including a phase I, 
     phase II, phase III, or phase IV trial) that is conducted in 
     relation to the treatment of cancer or other life-threatening 
     disease or condition and is described in any of the following 
     subparagraphs:
       ``(A) The study or investigation is approved or funded 
     (which may include funding through in-kind contributions) by 
     one or more of the following:
       ``(i) The National Institutes of Health.
       ``(ii) The Centers for Disease Control and Prevention.
       ``(iii) The Agency for Health Care Research and Quality.
       ``(iv) The Centers for Medicare & Medicaid Services.
       ``(v) A cooperative group or center of any of the entities 
     described in clauses (i) through (iv) or the Department of 
     Defense or the Department of Veterans Affairs.
       ``(vi) A qualified non-governmental research entity 
     identified in the guidelines issued by the National 
     Institutes of Health for center support grants.
       ``(vii) Any of the following if the conditions described in 
     paragraph (2) are met:

       ``(I) The Department of Veterans Affairs.
       ``(II) The Department of Defense.
       ``(III) The Department of Energy.

       ``(B) The study or investigation is conducted in accordance 
     with the requirements for investigational new drugs or 
     investigational devices under the Federal Food, Drug, and 
     Cosmetic Act.
       ``(C) The study or investigation is a clinical trial of a 
     drug or device that is exempt from the requirements described 
     under subparagraph (B).
       ``(2) Conditions for departments.--The conditions described 
     in this paragraph, for a study or investigation conducted by 
     a Department, are that the study or investigation has been 
     reviewed and approved through a system of peer review that 
     the Secretary determines--
       ``(A) to be comparable to the system of peer review of 
     studies and investigations used by the National Institutes of 
     Health, and
       ``(B) assures unbiased review of the highest scientific 
     standards by qualified individuals who have no interest in 
     the outcome of the review.
       ``(e) Life-Threatening Condition Defined.--In this section, 
     the term `life-threatening condition' means any disease or 
     condition from which the likelihood of death is probable 
     unless the course of the disease or condition is interrupted.
       ``(f) Construction.--Nothing in this section shall be 
     construed to limit a plan's or issuer's coverage with respect 
     to clinical trials.
       ``(g) Application to FEHBP.--Notwithstanding any provision 
     of chapter 89 of title 5, United States Code, this section 
     shall apply to health plans offered under the program under 
     such chapter.
       ``(h) Preemption.--Notwithstanding any other provision of 
     this Act, nothing in this section shall preempt State laws 
     that require a clinical trials policy for State regulated 
     health insurance plans that is in addition to the policy 
     required under this section.''.
                                 ______
                                 
  SA 2872. Mr. BROWN submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 1465, between lines 12 and 13, insert the 
     following:

     SEC. 5506. COUNTING RESIDENT TIME IN CERTAIN HOSPITALS.

       (a) GME.--Section 1886(h)(4) of the Social Security Act (42 
     U.S.C. 1395ww(h)(4)), as amended by sections 5504 and 5505, 
     is amended--
       (1) in subparagraph (E), by striking ``and (K)'' and 
     inserting ``, (K), and (L)''; and
       (2) by adding at the end the following new subparagraph:
       ``(L) Counting resident time in certain hospitals.--
       ``(i) In general.--Such rules shall provide that all the 
     time spent by a resident under an approved medical training 
     program in a hospital described in clause (ii) shall be 
     counted toward the determination of full-time equivalency by 
     the hospital that incurs the costs of the stipends and fringe 
     benefits of the resident during the time the resident spends 
     in the hospital described in clause (ii).
       ``(ii) Hospital described.--A hospital described in this 
     clause is a hospital that--

       ``(I) trains 3 or fewer full-time equivalent residents 
     annually;
       ``(II) consents, not later than 1 year after the date on 
     which the residents involved begin training under such 
     approved medical training program (and annually thereafter), 
     to forgo payments for direct graduate medical education costs 
     under this subsection for such residents; and
       ``(III) has not had an approved FTE resident amount 
     determined for the hospital under paragraph (2) as of the 
     date on which such residents begin such training.''.

       (b) IME.--Section 1886(d)(5)(B) of such Act (42 U.S.C. 
     1395ww(d)(5)(B)), as amended by section 5505, is amended by 
     adding at the end the following new clause:
       ``(xi) The provisions of subparagraph (L) of subsection 
     (h)(4) shall apply under this subparagraph in the same manner 
     as they apply under such subsection.''.
       (c) Conforming Amendment.--Section 1886(h)(2) of such Act 
     (42 U.S.C. 1395 ww(h)(2)) is amended by adding at the end the 
     following new subparagraph:
       ``(G) Exception to determination of per resident amount.--
     The Secretary shall not determine an approved FTE resident 
     amount under this paragraph for any hospital described in 
     paragraph (4)(L)(ii).''.
       (d) Effective Date.--The amendments made by this section 
     shall apply to cost reporting periods beginning on or after 
     January 1, 2009.
                                 ______
                                 
  SA 2873. Mr. BROWN submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       Beginning on page 1390, strike line 25 and all that follows 
     through line 21 on page 1393, and insert the following:
       ``(4) to identify and refer underserved populations to 
     appropriate healthcare agencies and community-based programs 
     and organizations in order to increase access to quality 
     healthcare services and to eliminate duplicative care; or
       ``(5) to educate, guide, and provide home visitation 
     services regarding maternal health and prenatal care.
       ``(c) Application.--Each eligible entity that desires to 
     receive a grant under subsection (a) shall submit an 
     application to the Secretary, at such time, in such manner, 
     and accompanied by such information as the Secretary may 
     require.
       ``(d) Priority.--In awarding grants under subsection (a), 
     the Secretary shall give priority to applicants that--
       ``(1) propose to target geographic areas--
       ``(A) with a high percentage of residents who are eligible 
     for health insurance but are uninsured or underinsured;
       ``(B) with a high percentage of residents who suffer from 
     chronic diseases; or
       ``(C) with a high infant mortality rate;
       ``(2) have experience in providing health or health-related 
     social services to individuals who are underserved with 
     respect to such services; and
       ``(3) have documented community activity and experience 
     with community health workers.
       ``(e) Collaboration With Academic Institutions and the One-
     Stop Delivery System.--The Secretary shall encourage 
     community health worker programs receiving funds under this 
     section to collaborate with academic institutions and one-
     stop delivery systems under section 134(c) of the Workforce 
     Investment Act of 1998. Nothing in this section shall be 
     construed to require such collaboration.
       ``(f) Evidence-Based Interventions.--The Secretary shall 
     encourage community health worker programs receiving funding 
     under this section to implement a process or an outcome-based 
     payment system that rewards community health workers for 
     connecting underserved populations with the most appropriate 
     services at the most appropriate time. Nothing in this 
     section shall be construed to require such a payment.
       ``(g) Quality Assurance and Cost Effectiveness.--The 
     Secretary shall establish guidelines for assuring the quality 
     of the training and supervision of community health workers 
     under the programs funded under this section and for assuring 
     the cost-effectiveness of such programs.

[[Page 29382]]

       ``(h) Monitoring.--The Secretary shall monitor community 
     health worker programs identified in approved applications 
     under this section and shall determine whether such programs 
     are in compliance with the guidelines established under 
     subsection (g).
       ``(i) Technical Assistance.--The Secretary may provide 
     technical assistance to community health worker programs 
     identified in approved applications under this section with 
     respect to planning, developing, and operating programs under 
     the grant.
       ``(j) Authorization of Appropriations.--There are 
     authorized to be appropriated, such sums as may be necessary 
     to carry out this section for each of fiscal years 2010 
     through 2014.
       ``(k) Definitions.--In this section:
       ``(1) Community health worker.--The term `community health 
     worker' means an individual who promotes health or nutrition 
     within the community in which the individual resides--
                                 ______
                                 
  SA 2874. Mr. BROWN submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 1069, line 1, insert ``community health workers,'' 
     after ``social workers,''.
                                 ______
                                 
  SA 2875. Mr. BROWN submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 536, line 10, insert ``community health worker,'' 
     after ``social worker,''.
                                 ______
                                 
  SA 2876. Mr. BROWN submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 816, after line 20, insert the following:

     SEC. 3115. WAIVER OF MEDICARE DME SURETY BOND REQUIREMENT FOR 
                   CERTAIN DME SUPPLIERS.

       Section 1834(a)(16) of the Social Security Act (42 U.S.C. 
     1395m(a)(16)) is amended by adding at the end the following 
     new sentence: ``The requirement for a surety bond described 
     in subparagraph (B) shall not apply in the case of a pharmacy 
     or supplier that exclusively provides eyeglasses or contact 
     lenses as described in section 1861(s)(8) that (i) is 
     enrolled under section 1866(j) as a supplier of durable 
     medical equipment, prosthetics, orthotics, and supplies and 
     has been issued (which may include renewal of) a provider 
     number (as described in the first sentence of this paragraph) 
     for at least 5 years, and (ii) for which a final adverse 
     action (as defined in section 424.57(a) of title 42, Code of 
     Federal Regulations) has never been imposed.''.
                                 ______
                                 
  SA 2877. Mr. BROWN submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 869, between lines 14 and 15, insert the following:

     SEC. 3143. REIMBURSEMENT FOR TOTAL BODY ORTHOTIC MANAGEMENT 
                   FOR CERTAIN NURSING HOME PATIENTS.

       (a) In General.--Not later than 60 days after the date of 
     the enactment of this Act, the Secretary of Health and Human 
     Services (in this section referred to as the ``Secretary'') 
     shall issue product codes that qualified practitioners and 
     suppliers may use to receive reimbursement under section 
     1834(h) of the Social Security Act (42 U.S.C. 1395m(h)) for 
     qualified total body orthotic management devices used for the 
     treatment of nonambulatory individuals with severe 
     musculoskeletal conditions who are in the full-time care of 
     skilled nursing facilities (as defined in section 1861(j) of 
     such Act (42 U.S.C. 1395x(j))). In issuing such codes, the 
     Secretary shall take all steps necessary to prevent fraud and 
     abuse.
       (b) Qualified Total Body Orthotic Management Device.--For 
     purposes of this section, the term ``qualified total body 
     orthotic management device'' means a medically-prescribed 
     device which--
       (1) consists of custom fitted individual braces with 
     adjustable points at the hips, knee, ankle, elbow, and wrist, 
     but only if--
       (A) the individually adjustable braces are attached to a 
     frame which is an integral component of the device and cannot 
     function or be used apart from the frame; and
       (B) the frame is designed such that it serves no purpose 
     without the braces; and
       (2) is designed to--
       (A) improve function;
       (B) retard progression of musculoskeletal deformity; or
       (C) restrict, eliminate, or assist in the functioning of 
     lower and upper extremities and pelvic, spinal, and cervical 
     regions of the body affected by injury, weakness, or 
     deformity, of an individual for whom stabilization of 
     affected areas of the body, or relief of pressure points, is 
     required for medical reasons.
                                 ______
                                 
  SA 2878. Mr. CARDIN submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the appropriate place, insert the following:

                        TITLE __MINORITY HEALTH

     SEC. __01. OFFICE OF MINORITY HEALTH.

       (a) In General.--Section 1707 of the Public Health Service 
     Act (42 U.S.C. 300u-6) is amended--
       (1) in subsection (a), by striking ``within the Office of 
     Public Health and Science and all that follows through the 
     end'' and inserting ``. The Office of Minority Health as 
     existing on the date of enactment of the Patient Protection 
     and Affordable Care Act shall be transferred to the Office of 
     the Secretary in such manner that there is established in the 
     Office of the Secretary, the Office of Minority Health, which 
     shall be headed by the Deputy Assistant Secretary for 
     Minority Health who shall report directly to the Secretary, 
     and shall retain and maintain an Advisory Committee on 
     Minority Health as provided for under subsection (c).'' and
       (2) by striking subsection (b) and inserting the following:
       ``(b) Duties.--With respect to improving the health of 
     racial and ethnic minority groups, the Secretary, acting 
     through the Deputy Assistant Secretary, shall carry out the 
     following:
       ``(1) Establish, implement, monitor, and evaluate short-
     range and long-range goals and objectives and oversee all 
     other activities within the Public Health Service that relate 
     to disease prevention, health promotion, service delivery, 
     and research concerning minority groups. The heads of each of 
     the agencies of the Service shall consult with the Deputy 
     Assistant Secretary to ensure the coordination of such 
     activities.
       ``(2) Oversee all activities within the Department of 
     Health and Human Services that relate to reducing or 
     eliminating disparities in health and health care in racial 
     and ethnic minority populations and in rural and underserved 
     communities, including coordinating--
       ``(A) the design of programs, support for programs, and the 
     evaluation of programs;
       ``(B) the monitoring of trends in health and health care;
       ``(C) research efforts;
       ``(D) the training of health providers; and
       ``(E) information and education programs and campaigns.
       ``(3) Enter into interagency and intra-agency agreements 
     with other agencies of the Public Health Service.
       ``(4) Ensure that the Federal health agencies and the 
     National Center for Health Statistics collect data on the 
     health status and health care of each minority group, using 
     at a minimum the categories specified in the 1997 OMB 
     Standards for Maintaining, Collecting, and Presenting Federal 
     Data on Race and Ethnicity as required under subtitle B and 
     available language standards.
       ``(5) Provide technical assistance to States, local 
     agencies, territories, Indian tribes, and entities for 
     activities relating to the elimination of racial and ethnic 
     disparities in health and health care.
       ``(6) Support a national minority health resource center to 
     carry out the following:
       ``(A) Facilitate the exchange of information regarding 
     matters relating to health information, health promotion and 
     wellness, preventive health services, clinical trials, health 
     information technology, and education in the appropriate use 
     of health services.
       ``(B) Facilitate timely access to culturally and 
     linguistically appropriate information.

[[Page 29383]]

       ``(C) Assist in the analysis of such information.
       ``(D) Provide technical assistance with respect to the 
     exchange of such information (including facilitating the 
     development of materials for such technical assistance).
       ``(7) Carry out programs to improve access to health care 
     services for individuals with limited English proficiency.
       ``(8) Carry out programs to improve access to health care 
     services and to improve the quality of health care services 
     for individuals with low functional health literacy. As used 
     in the preceding sentence, the term `functional health 
     literacy' means the ability to obtain, process, and 
     understand basic health information and services needed to 
     make appropriate health decisions.
       ``(9) Advise in matters related to the development, 
     implementation, and evaluation of health professions 
     education on decreasing disparities in health care outcomes, 
     with focus on cultural competency as a method of eliminating 
     disparities in health and health care in racial and ethnic 
     minority populations.
       ``(10) Assist health care professionals, community and 
     advocacy organizations, academic centers and public health 
     departments in the design and implementation of programs that 
     will improve the quality of health outcomes by strengthening 
     the provider-patient relationship.
       ``(11) In carrying our this subsection--
       ``(A) award grants, contracts, enter into memoranda of 
     understanding, cooperative, interagency, intra-agency and 
     other agreements with public and nonprofit private entities, 
     agencies, as well as Departmental and Cabinet agencies and 
     organizations; and
       ``(B) award grants, contracts, enter into memoranda of 
     understanding, cooperative and other agreements with 
     organizations that are indigenous human resource providers in 
     communities of color to assure improved health status of 
     racial and ethnic minorities.
       ``(12) Directly or through contracts with public and 
     private entities, agencies, and nonprofit organizations, 
     provide for evaluations of projects carried out with awards 
     made the Office and for the dissemination of information 
     developed as a result of such projects.'';
       (3) by redesignating subsections (f) through (h) as 
     subsections (g) through (i), respectively;
       (4) by inserting after subsection (e) the following:
       ``(f) Preparation of Health Professionals To Provide Health 
     Care to Minority Populations.--The Secretary, in 
     collaboration with the Director of the Bureau of Health 
     Professions and the Deputy Assistant Secretary for Minority 
     Health, shall require that health professional schools that 
     receive Federal funds train future health professionals to 
     provide culturally and linguistically appropriate health care 
     to diverse populations.''; and
       (5) by striking subsection (i) (as so redesignated) and 
     inserting the following:
       ``(i) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated such sums as may be necessary for each of fiscal 
     years 2011 through 2016.''.
       (b) Transfer of Functions.--There are transferred to the 
     Office of Minority Health in the office of the Secretary of 
     Health and Human Services, the Deputy Assistant Secretary for 
     Minority Health who shall report directly to the Secretary of 
     Health and Human Services. All duties, responsibilities, 
     accountabilities and functions exercised by the Deputy 
     Assistant Secretary for Minority Health and by the Office of 
     Minority Health of the Public Health Service prior to the 
     date of enactment of this section shall transfer with the 
     Office and the Deputy Assistant Secretary for Minority 
     Health, including all personnel and compensation authority, 
     all delegation and assignment authority, all committees 
     including the Advisory Committee on Minority Health and other 
     committees, entities and councils, and all remaining 
     appropriations. All orders, determinations, rules, 
     regulations, permits, agreements, grants, contracts, 
     certificates, licenses, registrations, privileges, and other 
     administrative actions that--
       (1) have been issued, made, granted, or allowed to become 
     effective by the President, any Federal agency or official 
     thereof, or by a court of competent jurisdiction, in the 
     performance of functions transferred under this paragraph; 
     and
       (2) transfers with the Deputy Assistant Secretary for 
     Minority Health are in effect at the time this section takes 
     effect, or were final before the date of enactment of this 
     section and are to become effective on or after such date, 
     transfers with and to the Office of Minority Health within 
     the Office of the Secretary and remain the authority, 
     responsibility and accountability of the Office;
     shall continue in effect according to their terms until 
     modified, terminated, superseded, set aside, or revoked in 
     accordance with law by the President, the Secretary, a court 
     of competent jurisdiction, or by operation of law.
       (c) Reports.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this section, and every second year thereafter, 
     the Secretary of Health and Human Services shall prepare and 
     submit to the appropriate committees of Congress a report 
     describing the activities carried out under section 1707 of 
     the Public Health Service Act (as amended by this section) 
     during the period for which the report is being prepared.
       (2) Agency reports.--Not later than 1 year after the date 
     of enactment of this section, and biennially thereafter, the 
     heads of each of the agencies of the Public Health Service 
     shall submit to the Deputy Assistant Secretary for Minority 
     Health a report summarizing the minority health activities of 
     each of the respective agencies.

     SEC. __02. ESTABLISHMENT OF INDIVIDUAL OFFICES OF MINORITY 
                   HEALTH WITHIN AGENCIES OF THE PUBLIC HEALTH 
                   SERVICE.

       Title XVII of the Public Health Service Act (42 U.S.C. 300u 
     et seq.) is amended by inserting after section 1707 the 
     following section:

     ``SEC. 1707A. INDIVIDUAL OFFICES OF MINORITY HEALTH WITHIN 
                   PUBLIC HEALTH SERVICE.

       ``(a) In General.--The head of each agency specified in 
     subsection (b)(1) shall establish within the agency an office 
     to be known as the Office of Minority Health. The head of 
     each such Office shall be appointed by the head of the agency 
     within which the Office is established, and shall report 
     directly to the head of the agency. The head of such agency 
     shall carry out this section (as this section relates to the 
     agency) acting through such Director.
       ``(b) Specified Agencies.--
       ``(1) In general.--The agencies referred to in subsection 
     (a) are the following:
       ``(A) The Centers for Disease Control and Prevention.
       ``(B) The Health Resources and Services Administration.
       ``(C) The Substance Abuse and Mental Health Services 
     Administration.
       ``(D) The Agency for Healthcare Research and Quality.
       ``(E) The Food and Drug Administration.
       ``(c) Composition.--The head of each specified agency shall 
     ensure that the officers and employees of the minority health 
     office of the agency are, collectively, experienced in 
     carrying out community-based health programs for each of the 
     various racial and ethnic minority groups that are present in 
     significant numbers in the United States.
       ``(d) Duties.--Each head of a minority health office shall 
     establish and monitor the programs of the specified agency of 
     such office in order to carry out the following:
       ``(1) Determine the extent to which the purposes of the 
     programs are being carried out with respect to racial and 
     ethnic minority groups;
       ``(2) Determine the extent to which members of such groups 
     are represented among the Federal officers and employees who 
     administer the programs; and
       ``(3) Make recommendations to the head of such agency on 
     carrying out the programs with respect to such groups. In the 
     case of programs that provide services, such recommendations 
     shall include recommendations toward ensuring that--
       ``(A) the services are equitably delivered with respect to 
     racial and ethnic minority groups; and
       ``(B) the programs provide the services in the language and 
     cultural context that is most appropriate for the individuals 
     for whom the services are intended.
       ``(e) Funding.--
       ``(1) Allocations.--Of the amounts appropriated for a 
     specified agency for a fiscal year, the Secretary must 
     designate an appropriate amount of funds for the purpose of 
     carrying out activities under this section through the 
     minority health office of the agency. In reserving an amount 
     under the preceding sentence for a minority health office for 
     a fiscal year, the Secretary shall reduce, by substantially 
     the same percentage, the amount that otherwise would be 
     available for each of the programs of the designated agency 
     involved.
       ``(2) Availability of funds for staffing.--The purposes for 
     which amounts made available under paragraph may be expended 
     by a minority health office include the costs of employing 
     staff for such office.''.

     SEC. __03. OFFICE OF MINORITY HEALTH AT THE CENTERS FOR 
                   MEDICARE & MEDICAID SERVICES.

       (a) In General.--Not later than 60 days after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall establish within the Centers for Medicare & 
     Medicaid Services an Office of Minority Health (referred to 
     in this section as the ``Office'').
       (b) Duties.--The Office shall be responsible for the 
     coordination and facilitation of activities of the Centers 
     for Medicare & Medicaid Services to improve minority health 
     and health care and to reduce racial and ethnic disparities 
     in health and health care, which shall include--
       (1) creating a strategic plan, which shall be made 
     available for public review, to improve the health and health 
     care of Medicare, Medicaid, and SCHIP beneficiaries;
       (2) promoting agency-wide policies relating to health care 
     delivery and financing that could have a beneficial impact on 
     the health and health care of minority populations;
       (3) assisting health plans, hospitals, and other health 
     entities in providing culturally

[[Page 29384]]

     and linguistically appropriate health care services;
       (4) increasing awareness and outreach activities for 
     minority health care consumers and providers about the causes 
     and remedies for health and health care disparities;
       (5) developing grant programs and demonstration projects to 
     identify, implement and evaluate innovative approaches to 
     improving the health and health care of minority 
     beneficiaries in the Medicare, Medicaid, and SCHIP programs;
       (6) considering incentive programs relating to 
     reimbursement that would reward health entities for providing 
     quality health care for minority populations using 
     established benchmarks for quality of care;
       (7) collaborating with the compliance office to ensure 
     compliance with the anti-discrimination provisions under 
     title VI of the Civil Rights Act of 1964;
       (8) identifying barriers to enrollment in public programs 
     under the jurisdiction of the Centers for Medicare & Medicaid 
     Services;
       (9) monitoring and evaluating on a regular basis the 
     success of minority health programs and initiatives;
       (10) publishing an annual report about the activities of 
     the Centers for Medicare & Medicaid Services relating to 
     minority health improvement; and
       (11) other activities determined appropriate by the 
     Secretary of Health and Human Services.
       (c) Staff.--The staff at the Office shall include--
       (1) one or more individuals with expertise in minority 
     health and racial and ethnic health disparities; and
       (2) one or more individuals with expertise in health care 
     financing and delivery in underserved communities.
       (d) Coordination.--In carrying out its duties under this 
     section, the Office shall coordinate with--
       (1) the Office of Minority Health in the Office of the 
     Secretary of Health and Human Services;
       (2) the National Institute for Minority Health and Health 
     Disparities (as so redesignated by section _05) in the 
     National Institutes of Health; and
       (3) the Office of Minority Health in the Centers for 
     Disease Control and Prevention.
       (e) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated such sums may be necessary for each of fiscal 
     years 2011 through 2016.

     SEC. __04. OFFICE OF MINORITY AFFAIRS AT THE FOOD AND DRUG 
                   ADMINISTRATION.

       Chapter X of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 391 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 1011. OFFICE OF MINORITY AFFAIRS.

       ``(a) In General.--Not later than 60 days after the date of 
     enactment of this section, the Secretary shall establish 
     within the Office of the Commissioner of Food and Drugs an 
     Office of Minority Affairs (referred to in this section as 
     the `Office').
       ``(b) Duties.--The Office shall be responsible for the 
     coordination and facilitation of activities of the Food and 
     Drug Administration to improve minority health and health 
     care and to reduce racial and ethnic disparities in health 
     and health care, which shall include--
       ``(1) promoting policies in the development and review of 
     medical products that reduce racial and ethnic disparities in 
     health and health care;
       ``(2) encouraging appropriate data collection, analysis, 
     and dissemination of racial and ethnic differences using, at 
     a minimum, the categories described in the 1997 Office of 
     Management and Budget standards, in response to different 
     therapies in both adult and pediatric populations;
       ``(3) providing, in coordination with other appropriate 
     government agencies, education, training, and support to 
     increase participation of minority patients and physicians in 
     clinical trials;
       ``(4) collecting and analyzing data using, at a minimum, 
     the categories described in the 1997 Office of Management and 
     Budget standards, on the number of participants from minority 
     racial and ethnic backgrounds in clinical trials used to 
     support medical product approvals;
       ``(5) the identification of methods to reduce language and 
     literacy barriers; and
       ``(6) publishing an annual report about the activities of 
     the Food and Drug Administration pertaining to minority 
     health.
       ``(c) Staff.--The staff of the Office shall include--
       ``(1) one or more individuals with expertise in the design 
     and conduct of clinical trials of drugs, biological products, 
     and medical devices; and
       ``(2) one or more individuals with expertise in therapeutic 
     classes or disease states for which medical evidence suggests 
     a difference based on race or ethnicity.
       ``(d) Coordination.--In carrying out its duties under this 
     section, the Office shall coordinate with--
       ``(1) the Office of Minority Health in the Office of the 
     Secretary of Health and Human Services;
       ``(2) the National Institute for Minority Health and Health 
     Disparities in the National Institutes of Health; and
       ``(3) the Office of Minority Health in the Centers for 
     Disease Control and Prevention.
       ``(e) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated such sums as may be necessary for each of the 
     fiscal years 2011 through 2016.''.

     SEC. __05. NATIONAL INSTITUTE FOR MINORITY HEALTH AND HEALTH 
                   DISPARITIES.

       (a) Redesignation.--
       (1) In general.--Title IV of the Public Health Service Act 
     (42 U.S.C. 281 et seq.) is amended--
       (A) in section 401(b)(24), by striking ``National Center on 
     Minority Health and Health Disparities'' and inserting 
     ``National Institute for Minority Health and Health 
     Disparities''; and
       (B) in subpart 6 of part E--
       (i) in the subpart heading, by striking ``Center'' and 
     inserting ``Institute'';
       (ii) in the headings of sections 485E and 485H, by striking 
     ``CENTER'' and inserting ``INSTITUTE''; and
       (iii) by striking (other than in section 485E(i)(1)) the 
     term ``Center'' each place it appears and inserting 
     ``Institute''.
       (2) References.--Any reference in any law, map, regulation, 
     document, paper, or other record of the United States to the 
     National Center on Minority Health and Health Disparities 
     shall be deemed to be a reference to the National Institute 
     for Minority Health and Health Disparities.
       (b) Duties; Authorities; Funding.--Section 485E of the 
     Public Health Service Act (42 U.S.C. 287c-31) is amended--
       (1) by amending subsection (e) to read as follows:
       ``(e) Duties of the Director.--
       ``(1) Interagency coordination of minority health and 
     health disparity activities.--With respect to minority health 
     and health disparities, the Director of the Institute shall 
     plan, coordinate, and evaluate research and other activities 
     conducted or supported by the institutes and centers of the 
     National Institutes of Health. In carrying out the preceding 
     sentence, the Director of the Institute shall evaluate the 
     minority health and health disparity activities of each of 
     such institutes and centers and shall provide for the 
     periodic reevaluation of such activities. Such institutes and 
     centers shall be responsible for providing information to the 
     Institute, including data on clinical trials funded or 
     conducted by these institutes and centers.
       ``(2) Consultations.--The Director of the Institute shall 
     carry out this subpart (including developing and revising the 
     plan and budget required by subsection (f) in consultation 
     with the heads of the institutes and centers of the National 
     Institutes of Health, the advisory councils of such 
     institutes and centers, and the advisory council established 
     pursuant to subsection (j).
       ``(3) Coordination of activities.--The Director of the 
     Institute--
       ``(A) shall act as the primary Federal official with 
     responsibility for coordinating all research and activities 
     conducted or supported by the National Institutes of Health 
     on minority or other health disparities;
       ``(B) shall represent the health disparities research 
     program of the National Institutes of Health, including the 
     minority health and other health disparities research 
     program, at all relevant executive branch task forces, 
     committees, and planning activities; and
       ``(C) shall maintain communications with all relevant 
     agencies of the Public Health Service, including the Indian 
     Health Service, and various other departments and agencies of 
     the Federal Government to ensure the timely transmission of 
     information concerning advances in minority health 
     disparities research and other health disparities research 
     among these various agencies for dissemination to affected 
     communities and health care providers.'';
       (2) by amending subsection (f) to read as follows:
       ``(f) Strategic Plan.--
       ``(1) In general.--Subject to the provisions of this 
     section and other applicable law, the Director of the 
     Institute, in consultation with the Director of NIH, the 
     Directors of the other institutes and centers of the National 
     Institutes of Health, and the advisory council established 
     pursuant to subsection (j), shall--
       ``(A) annually review and revise a strategic plan (referred 
     to in this section as `the plan') and budget for the conduct 
     and support of all minority health disparity research and 
     other health disparity research activities of the institutes 
     and centers of the National Institutes of Health that include 
     time-based targeted objectives with measurable outcomes and 
     assure that the annual review and revision of the plan uses 
     an established trans-National Institutes of Health process 
     subject to timely review, approval, and dissemination;
       ``(B) ensure that the plan and budget establish priorities 
     among the health disparities research activities that such 
     agencies are authorized to carry out;
       ``(C) ensure that the plan and budget establish objectives 
     regarding such activities, describe the means for achieving 
     the objectives, and designate the date by which the 
     objectives are expected to be achieved;
       ``(D) ensure that all amounts appropriated for such 
     activities are expended in accordance with the plan and 
     budget;

[[Page 29385]]

       ``(E) annually submit to Congress a report on the progress 
     made with respect to the plan; and
       ``(F) create and implement a plan for the systemic review 
     of research activities supported by the National Institutes 
     of Health that are within the mission of both the Institute 
     and other institutes and centers of the National Institutes 
     of Health, including by establishing mechanisms for--
       ``(i) tracking minority health and health disparity 
     research conducted within the institutes and centers 
     assessing the appropriateness of this research with regard to 
     the overall goals and objectives of the plan;
       ``(ii) the early identification of applications and 
     proposals for grants, contracts, and cooperative agreements 
     supporting extramural training, research, and development, 
     that are submitted to the institutes and centers that are 
     within the mission of the Institute;
       ``(iii) providing the Institute with the written 
     descriptions and scientific peer review results of such 
     applications and proposals;
       ``(iv) enabling the institutes and centers to consult with 
     the Director of the Institute prior to final approval of such 
     applications and proposals; and
       ``(v) reporting to the Director of the Institute all such 
     applications and proposals that are approved for funding by 
     the institutes and centers.
       ``(2) Certain components of plan and budget.--With respect 
     to health disparities research activities of the agencies of 
     the National Institutes of Health, the Director of the 
     Institute shall ensure that the plan and budget under 
     paragraph (1) provide for--
       ``(A) basic research and applied research, including 
     research and development with respect to products;
       ``(B) research that is conducted by the agencies;
       ``(C) research that is supported by the agencies;
       ``(D) proposals developed pursuant to solicitations by the 
     agencies and for proposals developed independently of such 
     solicitations; and
       ``(E) behavioral research and social sciences research, 
     which may include cultural and linguistic research in each of 
     the agencies.
       ``(3) Minority health disparities research.--The plan and 
     budget under paragraph (1) shall include a separate statement 
     of the plan and budget for minority health disparities 
     research.'';
       (3) by amending subsection (h) to read as follows:
       ``(h) Research Endowments.--
       ``(1) In general.--The Director of the Institute shall 
     carry out a program to facilitate minority health and health 
     disparities research and other health disparities research by 
     providing research endowments at--
       ``(A) centers of excellence under section 736; and
       ``(B) centers of excellence under section 485F.
       ``(2) Eligibility.--The Director of the Institute shall 
     provide for a research endowment under paragraph (1) only if 
     the institution involved meets the following conditions:
       ``(A) The institution does not have an endowment that is 
     worth in excess of an amount equal to 50 percent of the 
     national average of endowment funds at institutions that 
     conduct similar biomedical research or training of health 
     professionals.
       ``(B) The application of the institution under paragraph 
     (1) regarding a research endowment has been recommended 
     pursuant to technical and scientific peer review and has been 
     approved by the advisory council established pursuant to 
     subsection (j).
       ``(C) The institution at any time was deemed to be eligible 
     to receive a grant under section 736 and at any time received 
     a research endowment under paragraph (1).''; and
       (4) by adding at the end the following:
       ``(k) Funding.--
       ``(1) Full funding budget.--
       ``(A) In general.--With respect to a fiscal year, the 
     Director of the Institute shall prepare and submit directly 
     to the President, for review and transmittal to Congress, a 
     budget estimate for carrying out the plan for the fiscal 
     year, after reasonable opportunity for comment (but without 
     change) by the Secretary, the Director of the National 
     Institutes of Health, the directors of the other institutes 
     and centers of the National Institutes of Health, and the 
     advisory council established pursuant to subsection (j). The 
     budget estimate shall include an estimate of the number and 
     type of personnel needs for the Institute.
       ``(B) Amounts necessary.--The budget estimate submitted 
     under subparagraph (A) shall estimate the amounts necessary 
     for the institutes and centers of the National Institutes of 
     Health to carry out all minority health and health 
     disparities activities determined by the Director of the 
     Institute to be appropriate, without regard to the 
     probability that such amounts will be appropriated.
       ``(2) Alternate budgets.--
       ``(A) In general.--With respect to a fiscal year, the 
     Director of the Institute shall prepare and submit to the 
     Secretary and the Director of the National Institutes of 
     Health the budget estimates described in subparagraph (B) for 
     carrying out the plan for the fiscal year. The Secretary and 
     such Director shall consider each of such estimates in making 
     recommendations to the President regarding a budget for the 
     plan for such year.
       ``(B) Description.--With respect to the fiscal year 
     involved, the budget estimates referred to in subparagraph 
     (A) for the plan are as follows:
       ``(i) The budget estimate submitted under paragraph (1).
       ``(ii) A budget estimate developed on the assumption that 
     the amounts appropriated will be sufficient only for--

       ``(I) continuing the conduct by the institutes and centers 
     of the National Institutes of Health of existing minority 
     health and health disparity activities (if approved for 
     continuation), and continuing the support of such activities 
     by the institutes and centers in the case of projects or 
     programs for which the institutes or centers have made a 
     commitment of continued support; and
       ``(II) carrying out activities that are in addition to 
     activities specified in subclause (I), only for which the 
     Director determines there is the most substantial need.

       ``(iii) Such other budget estimates as the Director of the 
     Institute determines to be appropriate.''.
                                 ______
                                 
  SA 2879. Mr. CARDIN submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 974, between lines 9 and 10, insert the following:

     SEC. 3316. HHS STUDIES AND REPORTS ON MEDICAID BENEFICIARIES 
                   AND DUAL ELIGIBLE INDIVIDUALS RECEIVING CARE IN 
                   HOME AND COMMUNITY-BASED SETTINGS.

       (a) Study and Report on Dual Eligibles.--Not later than 180 
     days after the date of enactment of this Act, the Secretary 
     shall conduct a study and submit to Congress a report that--
       (1) analyzes whether dual eligible individuals (as 
     described under subsection (c)(1)) have income levels, 
     prescription drug requirements, and types and levels of 
     disability that are comparable to dual eligible individuals 
     for whom cost-sharing is eliminated under section 1860D-
     14(a)(1)(D)(i) of the Social Security Act (42 U.S.C. 1395w-
     114(a)(1)(D)(i)), as amended by section 3309;
       (2) determines whether dual eligible individuals have 
     adequate access to prescription medication; and
       (3) provides recommendations to address any deficiencies in 
     regard to access to prescription drugs by dual eligible 
     individuals, including an analysis regarding elimination of 
     cost sharing for all such individuals under the prescription 
     drug program under part D of title XVIII of the Social 
     Security Act.
       (b) Study and Report on SSI Low-Income Medicaid 
     Beneficiaries.--Not later than 12 months after the date of 
     enactment of this Act, the Secretary shall conduct a study 
     and submit to Congress a report that--
       (1) determines whether benefits provided to SSI Medicaid 
     beneficiaries (as described under subsection (c)(2)) under 
     the supplemental security income program are sufficient to 
     cover expenses for room and board that are incurred by such 
     beneficiaries;
       (2) analyzes the process used for determining the amount of 
     benefits provided to SSI Medicaid beneficiaries under the 
     supplemental security income program, including whether such 
     amounts--
       (A) adequately reflect expenses for room and board that are 
     incurred by such beneficiaries; and
       (B) are sufficient to meet the needs of beneficiaries who 
     are disabled; and
       (3) identifies methods to provide additional support for 
     SSI Medicaid beneficiaries in covering their expenses for 
     room and board, including benefits provided under Housing and 
     Urban Development programs and other housing assistance 
     programs, the supplemental nutrition assistance program 
     established under the Food and Nutrition Act of 2008 (7 
     U.S.C. 2011 et seq.), and other methods as determined 
     appropriate by the Secretary.
       (c) Definitions.--In this section:
       (1) Dual eligible individual.--The term ``dual eligible 
     individual'' means an individual who is--
       (A) entitled to benefits under part A of title XVIII of the 
     Social Security Act or enrolled for benefits under part B of 
     such title;
       (B) entitled to medical assistance under a State plan under 
     title XIX of such Act;
       (C) not an institutionalized individual or couple (as 
     defined in section 1902(q)(1)(B) of such Act (42 U.S.C. 
     1396a(q)(1)(B))); and
       (D) receiving home and community-based services under a 
     State Medicaid plan (or a waiver of such plan) under title 
     XIX of the Social Security Act.
       (2) SSI medicaid beneficiary.--The term ``SSI Medicaid 
     beneficiary'' means an individual who--

[[Page 29386]]

       (A) is eligible for medical assistance under a State plan 
     or waiver under title XIX of the Social Security Act and is 
     enrolled in such plan or waiver;
       (B) receives benefits under the supplemental security 
     income program under title XVI of the Social Security Act (42 
     U.S.C. 1381 et seq.); and
       (C) receives home and community-based services (including 
     such services provided in an assisted living facility).
       (3) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.

                          ____________________