[Congressional Record (Bound Edition), Volume 156 (2010), Part 4]
[Senate]
[Pages 4900-4941]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 3586. Mr. LeMIEUX submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

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

     SEC. 1207. MEMBERS OF CONGRESS REQUIRED TO HAVE COVERAGE 
                   UNDER MEDICAID INSTEAD OF THROUGH FEHBP.

       (a) In General.--Notwithstanding chapter 89 of title 5, 
     United States Code, title XIX of the Social Security Act, or 
     any provision of this Act, effective on the date of enactment 
     of this Act--
       (1) each Member of Congress shall be eligible for medical 
     assistance under the Medicaid plan of the State in which the 
     Member resides; and
       (2) any employer contribution under chapter 89 of title 5 
     of such Code on behalf of the Member may be paid only to the 
     State agency responsible for administering the Medicaid plan 
     in which the Member enrolls and not to the offeror of a plan 
     offered through the Federal employees health benefit program 
     under such chapter.
       (b) Payments by Federal Government.--The Secretary of 
     Health and Human Services, in consultation with the Director 
     of the Office of Personnel Management, shall establish 
     procedures under which the employer contributions that would 
     otherwise be made on behalf of a Member of Congress if the 
     Member were enrolled in a plan offered through the Federal 
     employees health benefit program may be made directly to the 
     State agencies described in subsection (a).
       (c) Ineligible for FEHBP.--Effective on the date of 
     enactment of this Act, no Member of Congress shall be 
     eligible to obtain health insurance coverage under the 
     program chapter 89 of title 5, United States Code.
       (d) Definition.--In this section, the term ``Member of 
     Congress'' means any member of the House of Representatives 
     or the Senate.

[[Page 4901]]


                                 ______
                                 
  SA 3587. Mr. BROWNBACK (for himself and Mr. Vitter) submitted an 
amendment intended to be proposed by him to the bill H.R. 4872, to 
provide for reconciliation pursuant to Title II of the concurrent 
resolution on the budget for fiscal year 2010 (S. Con. Res. 13); which 
was ordered to lie on the table; as follows:

       Strike section 1107.
                                 ______
                                 
  SA 3588. Mr. INHOFE submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 99, between lines 9 and 10, insert the following:
       (e) Exclusion of Medical Devices for Pediatric Use and 
     Persons With Disabilities.--
       (1) In general.--For purposes of section 4191(b)(1) of the 
     Internal Revenue Code of 1986, as added by subsection (a), 
     the term ``taxable medical device'' shall not include any 
     device which is primarily designed--
       (A) to be used by or for pediatric patients, or
       (B) to assist persons with disabilities with tasks of daily 
     life.
       (2) Expansion of affordability exception to individual 
     mandate.--Section 5000A(e)(1)(A) of the Internal Revenue Code 
     of 1986, as added by section 1501(b) of the Patient 
     Protection and Affordable Care Act and amended by section 
     10106 of such Act, is amended by striking ``8 percent'' and 
     inserting ``5 percent''.
       (3) Application of provision.--The amendment made by 
     paragraph (2) shall apply as if included in the Patient 
     Protection and Affordable Care Act.
                                 ______
                                 
  SA 3589. Ms. SNOWE submitted an amendment intended to be proposed by 
her to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 64, between lines 4 and 5, insert the following:

     SEC. 1201A. TRANSITIONAL STATE SHARE FOR COVERAGE OF PARENTS 
                   BY EXPANSION STATES.

       Section 1905(z) of the Social Security Act (42 U.S.C. 
     1396d(z)), as amended by section 1201, is amended by adding 
     at the end the following:
       ``(4) In the case of an expansion State described in 
     paragraph (3), the State percentage with respect to amounts 
     expended for medical assistance for individuals who are 
     parents described in subclause (VIII) of section 
     1902(a)(10)(A)(i) whose income (as determined under section 
     1902(e)(14)) exceeds 67 percent, but does not exceed 133 
     percent, of the poverty line (as defined in section 
     2110(c)(5)) applicable to a family of the size involved, and 
     who are not newly eligible (as defined in subsection (y)(2)), 
     shall be reduced as follows:
       ``(A) In the case of such expenditures for 2014, by 50 
     percent.
       ``(B) In the case of such expenditures for 2015, by 60 
     percent.
       ``(C) In the case of such expenditures for 2016, by 70 
     percent.
       ``(D) In the case of such expenditures for 2017, by 80 
     percent.
       ``(E) In the case of such expenditures for 2018, by 90 
     percent.''.
                                 ______
                                 
  SA 3590. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle A of title I, add the following:

     SEC. 1110. SPECIAL RULES TO ENSURE CITIZENS AND NATIONALS OF 
                   THE UNITED STATES HAVE THE SAME HEALTH CARE 
                   CHOICES AS LEGAL IMMIGRANTS.

       Section 36B(c)(1) of the Internal Revenue Code of 1986, as 
     added by section 1401 of the Patient Protection and 
     Affordable Care Act and amended by section 10105 of such Act, 
     is amended by adding at the end the following:
       ``(E) Special rules to ensure citizens and nationals of the 
     united states have the same health care choices as legal 
     immigrants.--
       ``(i) In general.--Notwithstanding any other provision of 
     this Code, the Patient Protection and Affordable Care Act, or 
     any amendment made by that Act, any taxpayer who--

       ``(I) is a citizen or national of the United States; and
       ``(II) has a household income which is not greater than 133 
     percent of an amount equal to the poverty line for a family 
     of the size involved,

     may elect to enroll in a qualified health plan through the 
     Exchange established by the State under section 1311 of the 
     Patient Protection and Affordable Care Act instead of 
     enrolling in the State Medicaid plan under title XIX of the 
     Social Security, or under a waiver of such plan.
       ``(ii) Special rules.--

       ``(I) An individual making an election under clause (i) 
     shall waive being provided with medical assistance under the 
     State Medicaid plan under title XIX of the Social Security, 
     or under a waiver of such plan while enrolled in a qualified 
     health plan.
       ``(II) In the case of an individual who is a child, the 
     child's parent or legal guardian may make such an election on 
     behalf of the child.
       ``(III) Any individual making such an election, or on whose 
     behalf such an election is made, shall--

       ``(aa) for purposes of the credit under this section, be 
     treated as an applicable taxpayer and the applicable 
     percentage with respect to such taxpayer shall be the 
     percentage determined under subsection (b)(3)(A)(i); and
       ``(bb) for purposes of reduced cost-sharing under section 
     1402 of the Patient Protection and Affordable Care Act, be 
     treated as an eligible individual whose household income is 
     in the category described in subsection (c)(2)(A) of such 
     section.''.
                                 ______
                                 
  SA 3591. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

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

     SEC. 23__. TREATMENT OF HIGH DEDUCTIBLE HEALTH PLANS AS 
                   QUALIFIED HEALTH PLANS.

       Subparagraph (B) of section 1301(a)(1) of the Patient 
     Protection and Affordable Care Act is amended by inserting 
     ``or meets the requirements for a high deductible health plan 
     under section 223(c)(2) of the Internal Revenue Code of 
     1986'' after ``section 1302(a)''.
                                 ______
                                 
  SA 3592. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, add the following:

     SEC. 1__. PROTECTION OF ACCESS TO QUALITY HEALTH CARE THROUGH 
                   THE DEPARTMENT OF VETERANS AFFAIRS AND THE 
                   DEPARTMENT OF DEFENSE.

       (a) Health Care Through Department of Veterans Affairs.--
     Nothing in this Act or the Patient Protection and Affordable 
     Care Act (or any amendment made by either such Act) shall be 
     construed to prohibit, limit, or otherwise penalize veterans 
     and dependents eligible for health care through the 
     Department of Veterans Affairs under the laws administered by 
     the Secretary of Veterans Affairs from receiving timely 
     access to quality health care in any facility of the 
     Department or from any non-Department health care provider 
     through which the Secretary provides health care.
       (b) Health Care Through Department of Defense.--
       (1) In general.--Nothing in this Act or the Patient 
     Protection and Affordable Care Act (or any amendment made by 
     either such Act) shall be construed to prohibit, limit, or 
     otherwise penalize eligible beneficiaries from receiving 
     timely access to quality health care in any military medical 
     treatment facility or under the TRICARE program.
       (2) Definitions.--In this subsection:
       (A) The term ``eligible beneficiaries'' means covered 
     beneficiaries (as defined in section 1072(5) of title 10, 
     United States Code) for purposes of eligibility for mental 
     and dental care under chapter 55 of title 10, United States 
     Code.
       (B) The term ``TRICARE program'' has the meaning given that 
     term in section 1072(7) of title 10, United States Code.
                                 ______
                                 
  SA 3593. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle B of title II, insert the following:

     SEC. 2__. HEALTH CARE SAFETY NET ENHANCEMENT.

       (a) Limitation on Liability.--Notwithstanding any other 
     provision of law, a health care professional shall not be 
     liable in any medical malpractice lawsuit for a cause of 
     action arising out of the provision of, or the failure to 
     provide, any medical service to a medically underserved or 
     indigent individual while engaging in the provision of pro 
     bono medical services.
       (b) Requirements.--Subsection (a) shall not apply--

[[Page 4902]]

       (1) to any act or omission by a health care professional 
     that is outside the scope of the services for which such 
     professional is deemed to be licensed or certified to 
     provide, unless such act or omission can reasonably be 
     determined to be necessary to prevent serious bodily harm or 
     preserve the life of the individual being treated;
       (2) if the services on which the medical malpractice claim 
     is based did not arise out of the rendering of pro bono care 
     for a medically underserved or indigent individual; or
       (3) to an act or omission by a health care professional 
     that constitutes willful or criminal misconduct, gross 
     negligence, reckless misconduct, or a conscious, flagrant 
     indifference to the rights or safety of the individual harmed 
     by such professional.
       (c) Definition.--In this section--
       (1) the term ``medically underserved individual'' means an 
     individual who does not have health care coverage under a 
     group health plan, health insurance coverage, or any other 
     health care coverage program; and
       (2) the term ``indigent individual'' means and individual 
     who is unable to pay for the health care services that are 
     provided to the individual.
                                 ______
                                 
  SA 3594. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, add the following:

     SEC. 15__. EQUIVALENT BANKRUPTCY PROTECTIONS FOR HEALTH 
                   SAVINGS ACCOUNTS AS RETIREMENT FUNDS.

       (a) In General.--Section 522 of title 11, United States 
     Code, is amended by adding at the end the following new 
     subsection:
       ``(r) Treatment of Health Savings Accounts.--For purposes 
     of this section, any health savings account (as described in 
     section 223 of the Internal Revenue Code of 1986) shall be 
     treated in the same manner as an individual retirement 
     account described in section 408 of such Code.''.
       (b) Effective Date.--The amendment made by this section 
     shall apply to cases commencing under title 11, United States 
     Code, after the date of the enactment of this Act.
                                 ______
                                 
  SA 3595. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle B of title II, insert the following:

     SEC. 2304. APPLICATION OF WELLNESS PROGRAMS PROVISIONS TO 
                   CARRIERS PROVIDING FEDERAL EMPLOYEE HEALTH 
                   BENEFITS PLANS.

       (a) In General.--Notwithstanding section 8906 of title 5, 
     United States Code (including subsections (b)(1) and (b)(2) 
     of such section), section 2705(j) of the Public Health 
     Service Act (relating to wellness programs) shall apply to 
     carriers entering into contracts under section 8902 of title 
     5, United States Code.
       (b) Proposals.--Carriers may submit separate proposals 
     relating to voluntary wellness program offerings as part of 
     the annual call for benefit and rate proposals to the Office 
     of Personnel Management.
       (c) Effective Date.--This section shall take effect on the 
     date of enactment of this Act and shall apply to contracts 
     entered into under section 8902 of title 5, United States 
     Code, that take effect with respect to calendar years that 
     begin more than 1 year after that date.
                                 ______
                                 
  SA 3596. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

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

     SEC. 1207. STATE OPTION TO OPT-OUT OF MEDICAID COVERAGE 
                   EXPANSION TO AVOID ASSUMING UNFUNDED FEDERAL 
                   MANDATE.

       Notwithstanding any provision of the Patient Protection and 
     Affordable Care Act (or any amendment made by such Act), the 
     Governor of a State shall have the authority to opt out of 
     any provision under such Act or any amendment made by such 
     Act that requires the State to expand coverage under the 
     Medicaid program if the State agency responsible for 
     administering the State plan under title XIX certifies that 
     such expansion would result in an increase of at least 1 
     percent in the total amount of expenditures by the State for 
     providing medical assistance to all individuals enrolled 
     under the State plan, when compared to the total amount of 
     such expenditures for the most recently ended State fiscal 
     year.
                                 ______
                                 
  SA 3597. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

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

     SEC. 23__. SOCIAL SECURITY NUMBER REQUIREMENT FOR 
                   PARTICIPATION IN EXCHANGES.

       Section 1411(b)(2) of the Patient Protection and Affordable 
     Care Act is amended by adding at the end the following new 
     flush sentence:

     ``For purposes of this section, the term `social security 
     number' means a social    security number issued to an 
     individual by the Social Security    Administration. Such 
     term shall not include a taxpayer identification number or 
     TIN issued by    the Internal Revenue Service.''.
                                 ______
                                 
  SA 3598. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

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

     SEC. __. ENSURING MEDICARE SAVINGS ARE KEPT IN THE MEDICARE 
                   PROGRAM.

       No reduction in outlays under the Medicare program under 
     title XVIII of the Social Security Act under the provisions 
     of, and amendments made by, this Act or the Patient 
     Protection and Affordable Care Act may be utilized to offset 
     any outlays under any other program or activity of the 
     Federal government.
                                 ______
                                 
  SA 3599. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. PROHIBITION ON USING MEDICARE SAVINGS TO OFFSET 
                   PROGRAMS UNRELATED TO MEDICARE.

       Title III of the Congressional Budget Act of 1974 (2 U.S.C. 
     621 et seq.) is amended by adding at the end the following:

     ``SEC. 316. PROHIBITION ON USING MEDICARE SAVINGS TO OFFSET 
                   PROGRAMS UNRELATED TO MEDICARE.

       ``For purposes of this title and title IV, a reduction in 
     outlays under title XVIII of the Social Security Act may not 
     be counted as an offset to any outlays under any other 
     program or activity of the Federal Government.''.
                                 ______
                                 
  SA 3600. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. PROHIBITION ON USING MEDICARE SAVINGS TO OFFSET 
                   PROGRAMS UNRELATED TO MEDICARE.

       Title III of the Congressional Budget Act of 1974 (2 U.S.C. 
     621 et seq.) is amended by adding at the end the following:

     ``SEC. 316. PROHIBITION ON USING MEDICARE SAVINGS TO OFFSET 
                   PROGRAMS UNRELATED TO MEDICARE.

       ``(a) In General.--For purposes of this title and title IV, 
     a reduction in outlays under title XVIII of the Social 
     Security Act or an increase in revenues resulting from an 
     increase in taxes assessed for purposes of such title may not 
     be counted as an offset to any outlays under any other 
     program or activity of the Federal Government.
       ``(b) Point of Order.--
       ``(1) In general.--It shall not be in order to consider any 
     bill, resolution, amendment, conference report, or motion 
     that violates subsection (a).
       ``(2) Waiver and appeal.--
       ``(A) Waiver.--This subsection may be waived or suspended 
     in the Senate only by the affirmative vote of three-fifths of 
     the Members, duly chosen and sworn.
       ``(B) Appeals.--Appeals in the Senate from the decisions of 
     the Chair relating to any provision of this subsection shall 
     be limited to 1 hour, to be equally divided between, and 
     controlled by, the appellant and the manager of the bill or 
     joint resolution, as the case may be. An affirmative vote of 
     three-fifths of the Members of the Senate, duly chosen and 
     sworn, shall be required to sustain an appeal of the ruling 
     of the Chair on a point of order raised under this 
     subsection.''.
                                 ______
                                 
  SA 3601. Mr. ENSIGN submitted an amendment intended to be proposed by

[[Page 4903]]

him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of section 1002, add the following:
       (c) Limitation on Liens and Levies.--Section 5000A(g)(2) of 
     the Internal Revenue Code of 1986, as added by the Patient 
     Protection and Affordable Care Act, is amended by striking 
     subparagraphs (A) and (B) and inserting the following:
       ``(A) Waiver of criminal and civil penalties and 
     interest.--In the case of any failure by a taxpayer to timely 
     pay any penalty imposed by this section--
       ``(i) such taxpayer shall not be subject to any criminal 
     prosecution or penalty with respect to such failure, and
       ``(ii) no penalty, addition to tax, or interest shall be 
     imposed with respect to such failure or such penalty.
       ``(B) Limited collection actions permitted.--In the case of 
     the assessment of any penalty imposed by this section, the 
     Secretary shall not take any action with respect to the 
     collection of such penalty other than--
       ``(i) giving notice and demand for such penalty under 
     section 6303,
       ``(ii) crediting under section 6402(a) the amount of any 
     overpayment of the taxpayer against such penalty, and
       ``(iii) offsetting any payment owed by any Federal agency 
     to the taxpayer against such penalty under the Treasury 
     offset program.''.
                                 ______
                                 
  SA 3602. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle E of title I, add the following:

     SEC. 14__. REPEAL OF ADDITIONAL TAX FROM DISTRIBUTIONS FROM 
                   HSAS AND MSAS.

       (a) HSAs.--Section 223(f)(4)(A) of the Internal Revenue 
     Code of 1986, as amended by section 9004 of the Patient 
     Protection and Affordable Care Act, is amended by striking 
     ``20 percent'' and inserting ``10 percent''.
       (b) Archer MSAs.--Section 220(f)(4)(A) of the Internal 
     Revenue Code of 1986, as amended by section 9004 of the 
     Patient Protection and Affordable Care Act, is amended by 
     striking ``20 percent'' and inserting ``15 percent''.
       (c) Effective Date.--The amendments made by this section 
     shall apply to distributions made after December 31, 2010.
                                 ______
                                 
  SA 3603. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       Strike section 1403 and insert the following:

     SEC. 1403. ELIMINATION OF LIMITATION ON HEALTH FLEXIBLE 
                   SPENDING ARRANGEMENTS UNDER CAFETERIA PLANS.

       (a) In General.--Section 125 of the Internal Revenue Code 
     of 1986, as amended by sections 9005 and 10902 of the Patient 
     Protection and Affordable Care Act, is amended by striking 
     subsection (i).
       (b) Effective Date.--The amendment made by this section 
     shall apply to taxable years beginning after December 31, 
     2010.
                                 ______
                                 
  SA 3604. Mr. BENNETT submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle E of title I, add the following:

     SEC. 1412. SUNSET FOR EXPANSIONS OF ENTITLEMENT SPENDING.

       (a) In General.--Notwithstanding any other provision of 
     this Act or the Patient Protection and Affordable Care Act 
     (or any amendments made by such Acts), any establishment or 
     expansion of entitlement authority (as defined in subsection 
     (b)) that is provided for under this Act or the Patient 
     Protection and Affordable Care Act (or any amendments made by 
     such Acts) that would draw from the general funds of the 
     Treasury, the Federal Hospital Insurance Trust Fund (as 
     established under section 1817 of the Social Security Act (42 
     U.S.C. 1395i)), the Federal Supplementary Medical Insurance 
     Trust Fund (as established under section 1841 of such Act (42 
     U.S.C. 1395t)), or any other such trust fund, shall terminate 
     at the end of fiscal year 2020.
       (b) Entitlement Authority.--In this section, the term 
     ``entitlement authority'' means the authority to make 
     payments (including loans and grants), the budget authority 
     for which is not provided for in advance by appropriation 
     Acts, to any person or government if, under the provisions of 
     the law containing that authority, the United States is 
     obligated to make such payments to persons or government who 
     meet the requirements established by that law.
                                 ______
                                 
  SA 3605. Mr. BENNETT submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

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

     SEC. 1207. STATE EXEMPTION FROM MEDICAID EXPANSION TO PREVENT 
                   REDUCTION IN MEDICAL SERVICES.

       Notwithstanding any other provision of law, no State shall 
     be required to expand coverage under the Medicaid program on 
     or after the date of enactment of the Patient Protection and 
     Affordable Care Act if the State agency responsible for 
     administering the State Medicaid plan under title XIX of the 
     Social Security Act certifies that such expansion would 
     require the State to reduce or eliminate care or services 
     provided to individuals who are eligible for medical 
     assistance under such State plan on the date of enactment of 
     the Patient Protection and Affordable Care Act.
                                 ______
                                 
  SA 3606. Mr. BENNETT submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 61, between lines 3 and 4, insert the following:

     SEC. 1110. APPLICATION OF UNUSED STIMULUS FUNDS FOR UPDATING 
                   OF THE MEDICARE PHYSICIAN FEE SCHEDULE.

       (a) Rescission in ARRA.--Effective as the date of enactment 
     of this Act, any unobligated balances available on such date 
     of funds made available by division A of the American 
     Recovery and Reinvestment Act of 2009 (Public Law 111-5) are 
     rescinded.
       (b) Update of Medicare Physician Fee Schedule.--The 
     Secretary of Health and Human Services shall increase the 
     update to the conversion factor under section 1848 of the 
     Social Security Act (42 U.S.C. 1395w-4) for physicians' 
     services so that the estimated total amount of payments for 
     such services furnished during fiscal years 2010 through 2019 
     is equal to the estimated total amount of payments for such 
     services that would have been made in such fiscal years if 
     this section did not apply plus an amount equal to the total 
     funds rescinded under subsection (a).
                                 ______
                                 
  SA 3607. Mr. BENNETT submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 113, after line 21, insert the following:

     SEC. 1502. STATE OPTION TO OPT-OUT OF NEW FEDERAL PROGRAM AND 
                   REQUIREMENTS.

       (a) In General.--In accordance with this section, a State 
     may elect for the provisions of the Patient Protection and 
     Affordable Care Act to not apply within such State to the 
     extent that such provisions violate the protections described 
     in subsection (b).
       (b) Effect of Opt-Out.--In the case of a State that makes 
     an election under subsection (a)--
       (1) the residents of such State shall not be subject to any 
     requirement under such Act, including tax provisions or 
     penalties, that would otherwise require such residents to 
     purchase health insurance;
       (2) the employers located in such State shall not be 
     subject to any requirement under such Act, including tax 
     provisions or penalties, that would otherwise require such 
     employers to provide health insurance to their employees or 
     make contributions relating to health insurance;
       (3) the residents of such State shall not be prohibited 
     under such Act from receiving health care services from any 
     provider of health care services under terms and conditions 
     subject to the laws of such State and mutually acceptable to 
     the patient and the provider;
       (4) the residents of such State shall not be prohibited 
     under such Act from entering into a contract subject to the 
     laws of such State with any group health plan, health 
     insurance issuer, or other business, for the provision of, or 
     payment to other parties for, health care services;
       (5) the eligibility of residents of such State for any 
     program operated by or funded wholly or partly by the Federal 
     Government shall not be adversely affected as a result of 
     having received services in a manner consistent with 
     paragraphs (3) and (4);

[[Page 4904]]

       (6) the health care providers within such State shall not 
     be denied participation in or payment from a Federal program 
     for which they would otherwise be eligible as a result of 
     having provided services in a manner consistent with 
     paragraphs (3) and (4); and
       (7) such State shall not be subject to the taxes and fees 
     enumerated in the amendments made by title IX of such Act.
       (c) Process.--A State shall be treated as making an 
     election under subsection (a) if--
       (1) the Governor of such State provides timely and 
     appropriate notice, at least 180 days before the election is 
     to become effective, to the Secretary of Health and Human 
     Services notifying the Secretary that the State is making 
     such election; or
       (2) the legislature of such State enacts a law to provide 
     for such election.
                                 ______
                                 
  SA 3608. Mrs. HUTCHISON (for herself, Mr. Enzi, Mr. Coburn, Mr. Burr, 
Mr. Brown of Massachusetts, and Mr. Crapo) proposed an amendment to the 
bill H.R. 4872, to provide for reconciliation pursuant to Title II of 
the concurrent resolution on the budget for fiscal year 2010 (S. Con. 
Res. 13); as follows:

       At the end of section 1002, insert the following:
       (c) Right of States to Opt Out of Federal Health Care 
     Takeover.--Section 1321(d) of the Patient Protection and 
     Affordable Care Act is amended--
       (1) by striking ``Nothing'' and inserting:
       ``(1) In general.--Except as provided in paragraph (2), 
     nothing''; and
       (2) by adding at the end the following:
       ``(2) Exception for opt out of health care reform.--The 
     provisions of, and the amendments made by, this Act shall not 
     preempt any State law enacted after the date of enactment of 
     this Act that exempts the State from such provisions or 
     amendments, including, but not limited to, provisions and 
     amendments relating to the individual mandate, the employer 
     mandate, taxes on prescription drugs, taxes on medical 
     devices, taxes on high value health plans, Medicare cuts, and 
     the unfunded expansion of Medicaid.''.
                                 ______
                                 
  SA 3609. Mr. JOHANNS submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle B of title I, insert the following:

     SEC. ___. DISCLOSURE OF AGREEMENTS WITH COMPANIES, UNIONS, 
                   AND ASSOCIATIONS.

       Not later than 30 days after the date of enactment of this 
     Act, the President shall disclose any agreement made between 
     the White House or any of its designees and a company, union, 
     or association on the Patient Protection and Affordable Care 
     Act or this Act.
                                 ______
                                 
  SA 3610. Mr. JOHANNS submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 144, between lines 2 and 3, insert the following:

     SEC. 2214. ONGOING RECORD OF JOBS LOST.

       The Secretary of Labor shall keep an ongoing record of jobs 
     lost due to the termination of the Robert T. Stafford Federal 
     Student Loan Program.
                                 ______
                                 
  SA 3611. Mr. JOHANNS submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

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

     SEC. __. DELAYED IMPLEMENTATION.

       Notwithstanding any other provision of this Act or the 
     Patient Protection and Affordable Care Act, or the amendments 
     made by this Act or the Patient Protection and Affordable 
     Care Act, such provisions and amendments shall not take 
     effect before the date that the Board of Trustees of the 
     Federal Hospital Insurance Trust Fund under section 1817 of 
     the Social Security Act (42 U.S.C. 1395i) submits an annual 
     report to Congress under subsection (b)(2) of such section 
     that includes a statement that such Trust Fund is projected 
     to be solvent through 2037.
                                 ______
                                 
  SA 3612. Mr. JOHANNS submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle B of title I, insert the following:

     SEC. ___. STATE OPT OUT.

       A State may opt out of the application of the Patient 
     Protection and Affordable Care Act and this Act effective 
     upon notice by the Governor of that State to the President.
                                 ______
                                 
  SA 3613. Mr. JOHANNS submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle B of title I, insert the following:

     SEC. ___. PROHIBITING IRS HIRING.

       The Internal Revenue Service shall not hire any additional 
     staff for the purpose of enforcing, implementing, or 
     administering the Patient Protection and Affordable Care Act 
     and this Act.
                                 ______
                                 
  SA 3614. Mr. JOHANNS submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle B of title I, insert the following:

     SEC. ___. JOB LOSS RECORDS DUE TO HEALTH CARE BILL.

       The Director of the Office of Management and Budget, in 
     coordination with the Secretary of Labor, shall submit a 
     semiannual public report to Congress detailing the record of 
     jobs lost due to additional taxes, fees, and mandates 
     contained in the Patient Protection and Affordable Care Act 
     and this Act.
                                 ______
                                 
  SA 3615. Mr. JOHANNS submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

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

     SEC. 1207. NONAPPLICATION OF ANY MEDICAID ELIGIBILITY 
                   EXPANSION UNTIL REDUCTION IN MEDICAID FRAUD 
                   RATE.

       Notwithstanding any other provision of law, with respect to 
     a State, any provision of law that imposes on or after the 
     date of enactment of this Act a federally-mandated expansion 
     of eligibility for Medicaid shall not apply to the State 
     before the date on which the State Medicaid Director 
     certifies to the Secretary of Health and Human Services that 
     the Medicaid payment error rate measurement (commonly 
     referred to as ``PERM'') for the State does not exceed 5 
     percent.
                                 ______
                                 
  SA 3616. Mr. JOHANNS submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

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

     SEC. __. EXEMPTING CRITICAL ACCESS HOSPITALS FROM 
                   RECOMMENDATIONS OF THE INDEPENDENT PAYMENT 
                   ADVISORY BOARD.

       Section 1899A(c)(2)(A) of the Social Security Act, as added 
     by section 3403 of the Patient Protection and Affordable Care 
     Act and amended by section 10320 of such Act, is amended by 
     adding at the end the following new clause:
       ``(vii) The proposal shall not include any recommendation 
     that would reduce payment rates for items and services 
     furnished by a critical access hospital (as defined in 
     section 1861(mm)(1)).''.
                                 ______
                                 
  SA 3617. Mr. JOHANNS submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 144, between lines 2 and 3, insert the following:

     SEC. 2214. PROHIBITION REGARDING SPENDING FOR ADDITIONAL 
                   EDUCATION EMPLOYEES AND FOR IMPLEMENTING THE 
                   GOVERNMENT TAKEOVER OF THE STUDENT LOAN 
                   INDUSTRY.

       Notwithstanding any other provision of this subtitle, none 
     of the funds made available under this subtitle or the 
     amendments made by this subtitle shall be available to hire 
     additional employees at the Department of Education who are 
     responsible for implementing, or to implement, the provisions 
     of this subtitle or the amendments made by

[[Page 4905]]

     this subtitle related to the termination of the Robert T. 
     Stafford Federal Student Loan Program.
                                 ______
                                 
  SA 3618. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       Strike section 1403 and insert the following:

     SECTION 1403. REPEAL OF LIMITATION ON FLEXIBLE SPENDING 
                   ARRANGEMENTS UNDER CAFETERIA PLANS.

       Sections 9005 and 10902 of the Patient Protection and 
     Affordable Care Act are hereby repealed effective as of the 
     date of the enactment of such Act and any provisions of law 
     amended by such sections are amended to read as such 
     provisions would read if such sections had never been 
     enacted.
                                 ______
                                 
  SA 3619.  Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       Strike section 1105 and insert the following:

     SEC. 1105. REPEAL OF THE PRODUCTIVITY AND OTHER MARKET BASKET 
                   ADJUSTMENTS.

       Effective as if included in the enactment of the Patient 
     Protection and Affordable Care Act, sections 3401 and 10319 
     of such Act (and the amendments made by such sections) are 
     repealed.
                                 ______
                                 
  SA 3620. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of section 1003, add the following:
       (e) Increase in Size of Applicable Large Employer.--Section 
     4980H(d)(2) of the Internal Revenue Code of 1986, as added by 
     the Patient Protection and Affordable Care Act, is amended by 
     striking ``50'' each place it appears and inserting ``499''.
                                 ______
                                 
  SA 3621. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle E of title I, add the following:

     SECTION 14__. REPEAL OF LIMITATION ON DEDUCTIONS FOR OVER-
                   THE-COUNTER MEDICINE.

       Section 9003 of the Patient Protection and Affordable Care 
     Act is hereby repealed effective as of the date of the 
     enactment of such Act and any provisions of law amended by 
     such section is amended to read as such provision would read 
     if such section had never been enacted.
                                 ______
                                 
  SA 3622. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle E of title I, add the following:

     SEC. 14__. REPEAL OF ADDITIONAL TAX FROM DISTRIBUTIONS FROM 
                   HSAS AND MSAS.

       (a) HSAs.--Section 223(f)(4)(A) of the Internal Revenue 
     Code of 1986, as amended by section 9004 of the Patient 
     Protection and Affordable Care Act, is amended by striking 
     ``20 percent'' and inserting ``10 percent''.
       (b) Archer MSAs.--Section 220(f)(4)(A) of the Internal 
     Revenue Code of 1986, as amended by section 9004 of the 
     Patient Protection and Affordable Care Act, is amended by 
     striking ``20 percent'' and inserting ``15 percent''.
       (c) Effective Date.--The amendments made by this section 
     shall apply to distributions made after December 31, 2010.
                                 ______
                                 
  SA 3623. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       Strike section 1402 and insert the following:

     SECTION 1402. REPEAL OF ADDITIONAL HOSPITAL INSURANCE TAX AND 
                   UNEARNED INCOME MEDICARE CONTRIBUTION.

       Sections 9015 and 10906 of the Patient Protection and 
     Affordable Care Act are hereby repealed effective as of the 
     date of the enactment of such Act and any provisions of law 
     amended by such sections are amended to read as such 
     provisions would read if such sections had never been 
     enacted.
                                 ______
                                 
  SA 3624. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle E of title I, add the following:

     SECTION 14__. REPEAL OF MODIFICATION OF ITEMIZED DEDUCTION 
                   FOR MEDICAL EXPENSES.

       Section 9013 of the Patient Protection and Affordable Care 
     Act is hereby repealed effective as of the date of the 
     enactment of such Act and any provisions of law amended by 
     such section is amended to read as such provision would read 
     if such section had never been enacted.
                                 ______
                                 
  SA 3625. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       Strike section 1401 and insert the following:

     SECTION 1401. REPEAL OF EXCISE TAX ON HIGH COST EMPLOYER-
                   SPONSORED HEALTH COVERAGE.

       Sections 9001 and 10901 of the Patient Protection and 
     Affordable Care Act are hereby repealed effective as of the 
     date of the enactment of such Act and any provisions of law 
     amended by such sections are amended to read as such 
     provisions would read if such sections had never been 
     enacted.
                                 ______
                                 
  SA 3626. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, add the following::

     SEC. 15__. NON-APPLICATION OF PROVISIONS TO CERTAIN 
                   INDIVIDUALS.

       (a) In General.--Notwithstanding any provision of, or 
     amendment made by, this Act or the Patient Protection and 
     Affordable Care Act, no such provision or amendment which, 
     directly or indirectly, results in an increase in Federal tax 
     liability with respect to any taxpayer for any taxable year 
     described in subsection (b) shall be administered in such a 
     manner as to impose such an increase on such taxpayer.
       (b) Federal Tax Increase.--An increase in Federal tax 
     liability with respect to any taxpayer for any taxable year 
     is described in this subsection if the amount of Federal 
     taxes owed for such taxable year is in excess of the amount 
     of Federal taxes which would be owed by such taxpayer for 
     such taxable year under the Internal Revenue Code of 1986 as 
     in effect for taxable years beginning in 1999.
                                 ______
                                 
  SA 3627. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle E of title I, add the following:

     SEC. 14__. NO FEDERAL TAX INCREASE IMPOSED ON MIDDLE INCOME 
                   INDIVIDUALS AND FAMILIES.

       (a) In General.--Notwithstanding any provision of, or 
     amendment made by, this Act or the Patient Protection and 
     Affordable Care Act, no such provision or amendment which, 
     directly or indirectly, results in a Federal tax increase 
     shall be administered in such manner as to impose such an 
     increase on any middle income taxpayer.
       (b) Middle Income Taxpayer.--For purposes of this section, 
     the term ``middle income taxpayer'' means, for any taxable 
     year, any taxpayer with adjusted gross income (as defined in 
     section 62 of the Internal Revenue Code of 1986) of less than 
     $200,000 ($250,000 in the case of a joint return of tax).
                                 ______
                                 
  SA 3628. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:


[[Page 4906]]

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

     SEC. __. REPEAL OF THE CENTER FOR MEDICARE AND MEDICAID 
                   INNOVATION.

       (a) In General.--Effective as if included in the enactment 
     of the Patient Protection and Affordable Care Act, sections 
     3021 and 10306 of such Act (and the amendments made by such 
     sections) are repealed.
       (b) Conforming Amendments.--
       (1) Section 2705 of the Patient Protection and Affordable 
     Care Act is amended--
       (A) in subsection (a), by striking ``shall, in 
     coordination'' and that follows through ``establish'' and 
     inserting ``shall establish''; and
       (B) in subsection (d)(2), by striking ``section 1115A(b)(3) 
     of the Social Security Act (as so added)'' and inserting 
     ``the Social Security Act''.
       (2) Section 1899(b)(4) of the Social Security Act, as added 
     by section 3022 of the Patient Protection and Affordable Care 
     Act, is amended by striking ``any of the following'' and all 
     that follows through the period at the end of subparagraph 
     (B) and inserting ``the independence at home medical practice 
     pilot program under section 1866E.''.
       (3) Section 933 of the Public Health Service Act, as added 
     by section 3501 of the Patient Protection and Affordable Care 
     Act, is amended by striking subsection (f).
       (4) Section 10328(b) of the Patient Protection and 
     Affordable Care Act is amended by striking ``or to study'' 
     and all that follows through ``3021''.
       (5) Effective date.--The amendments made by this subsection 
     shall take effect as if included in the enactment of the 
     Patient Protection and Affordable Care Act.
                                 ______
                                 
  SA 3629. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

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

     SEC. __. REPEAL OF THE INDEPENDENT PAYMENT ADVISORY BOARD.

       Effective as if included in the enactment of the Patient 
     Protection and Affordable Care Act, sections 3403 and 10320 
     of such Act (and the amendments made by such sections) are 
     repealed.
                                 ______
                                 
  SA 3630. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       Beginning on page 30, strike line 17 and all that follows 
     through page 50, line 11.
                                 ______
                                 
  SA 3631. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle B of title I, insert the following:

     SEC. __. REPEALING PAYMENT ADJUSTMENTS FOR HOME HEALTH CARE.

       Effective as if included in the enactment of the Patient 
     Protection and Affordable Care Act, sections 3131 and 3401(e) 
     of such Act (and the amendments made by such sections) are 
     repealed.
                                 ______
                                 
  SA 3632. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle B of title I, insert the following:

     SEC. __. REPEALING PAYMENT ADJUSTMENTS FOR HOSPICE CARE.

       Effective as if included in the enactment of the Patient 
     Protection and Affordable Care Act, sections 3004(c), 3132, 
     and 3401(g) of such Act (and the amendments made by such 
     sections) are repealed.
                                 ______
                                 
  SA 3633. Mr. CRAPO submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       Strike section 1104 and insert the following:

     SEC. 1104. REPEALING CUTS TO MEDICARE DISPROPORTIONATE SHARE 
                   HOSPITAL PAYMENTS.

       Effective as if included in the enactment of the Patient 
     Protection and Affordable Care Act, sections 3133 and 10316 
     of such Act (and the amendments made by such sections) are 
     repealed.
                                 ______
                                 
  SA 3634. Mrs. HUTCHISON submitted an amendment intended to be 
proposed by her to the bill H.R. 4872, to provide for reconciliation 
pursuant to Title II of the concurrent resolution on the budget for 
fiscal year 2010 (S. Con. Res. 13); which was ordered to lie on the 
table; as follows:

       At the end of subtitle A of title I, insert the following:

     SEC. 1006. REPEAL OF TAXABLE YEAR LIMITATION ON SMALL 
                   BUSINESS TAX CREDIT.

       (a) In General.--Section 45R of the Internal Revenue Code 
     of 1986, as added by section 1421 of the Patient Protection 
     and Affordable Care Act and amended by section 10105(e) of 
     such Act, is amended--
       (1) by striking ``in the credit period'' in subsection (a),
       (2) in subsection (e), by striking paragraph (2) and 
     redesignating paragraphs (3), (4), and (5) as paragraphs (2), 
     (3), and (4), respectively,
       (3) in subsection (g), by striking paragraph (1) and 
     redesignating paragraphs (2) and (3) as paragraphs (1) and 
     (2), respectively, and
       (4) by striking ``to prevent the avoidance of the 2-year 
     limit on the credit period through the use of successor 
     entities and'' in subsection (i).
       (b) Effective Date.--The amendments made by this section 
     shall take effect as if included in the provisions of the 
     Patient Protection and Affordable Care Act to which the 
     amendments relate.
                                 ______
                                 
  SA 3635. Mrs. HUTCHISON submitted an amendment intended to be 
proposed by her to the bill H.R. 4872, to provide for reconciliation 
pursuant to Title II of the concurrent resolution on the budget for 
fiscal year 2010 (S. Con. Res. 13); which was ordered to lie on the 
table; as follows:

       At the end of subtitle F of title I, add the following:

     SEC. 15__. PERMANENT TAX RELIEF PROVISIONS.

       (a) Repeal of Sunset on Marriage Penalty Relief.--Title IX 
     of the Economic Growth and Tax Relief Reconciliation Act of 
     2001 (relating to sunset of provisions of such Act) shall not 
     apply to sections 301, 302, and 303(a) of such Act (relating 
     to marriage penalty relief).
       (b) Permanent Extension of Election to Deduct State and 
     Local Sales Taxes.--Subparagraph (I) of section 164(b)(5) of 
     the Internal Revenue Code of 1986 is amended by striking ``, 
     and before January 1, 2010''.
       (c) Rescission of Stimulus Funds.--Any amounts appropriated 
     or made available and remaining unobligated under division A 
     of the American Recovery and Reinvestment Act of 2009 (Public 
     Law 111-5; 123 Stat. 115) (other than under title X of such 
     division A), are hereby rescinded.
                                 ______
                                 
  SA 3636. Mr. BROWNBACK submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 113, after line 21, add the following:

     SEC. 1502. CIVIL ACTIONS.

       For purposes of any civil action in which a State 
     challenges any provision of this Act, or an amendment made by 
     this Act, the State shall be--
       (1) deemed to be a party for purposes of section 2412(d) of 
     title 28, United States Code; and
       (2) entitled to an award of attorney's fees under section 
     2412(d)(1)(A) of title 28, United States Code, if the State 
     is a prevailing party, without regard to whether the position 
     of the United States was substantially justified or whether 
     there are special circumstances.
                                 ______
                                 
  SA 3637. Mr. BROWNBACK submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 113, after line 21, add the following:

     SEC. 1502. OPEN FUEL STANDARD.

       (a) Short Title.--This section may be cited as the ``Open 
     Fuel Standard Act of 2009'' or the ``OFS Act''.
       (b) Findings.--Congress makes the following findings:
       (1) The status of oil as a strategic commodity, which 
     derives from its domination of the transportation sector, 
     presents a clear and present danger to the United States;
       (2) in a prior era, when salt was a strategic commodity, 
     salt mines conferred national

[[Page 4907]]

     power and wars were fought over the control of such mines;
       (3) technology, in the form of electricity and 
     refrigeration, decisively ended salt's monopoly of meat 
     preservation and greatly reduced its strategic importance;
       (4) fuel competition and consumer choice would similarly 
     serve to end oil's monopoly in the transportation sector and 
     strip oil of its strategic status;
       (5) the current closed fuel market has allowed a cartel of 
     petroleum exporting countries to inflate fuel prices, 
     effectively imposing a harmful tax on the economy of the 
     United States;
       (6) much of the inflated petroleum revenues the oil cartel 
     earns at the expense of the people of the United States are 
     used for purposes antithetical to the interests of the United 
     States and its allies;
       (7) alcohol fuels, including ethanol and methanol, could 
     potentially provide significant supplies of additional fuels 
     that could be produced in the United States and in many other 
     countries in the Western Hemisphere that are friendly to the 
     United States;
       (8) alcohol fuels can only play a major role in securing 
     the energy independence of the United States if a substantial 
     portion of vehicles in the United States are capable of 
     operating on such fuels;
       (9) it is not in the best interest of United States 
     consumers or the United States Government to be constrained 
     to depend solely upon petroleum resources for vehicle fuels 
     if alcohol fuels are potentially available;
       (10) existing technology, in the form of flexible fuel 
     vehicles, allows internal combustion engine cars and trucks 
     to be produced at little or no additional cost, which are 
     capable of operating on conventional gasoline, alcohol fuels, 
     or any combination of such fuels, as availability or cost 
     advantage dictates, providing a platform on which fuels can 
     compete;
       (11) the necessary distribution system for such alcohol 
     fuels will not be developed in the United States until a 
     substantial fraction of the vehicles in the United States are 
     capable of operating on such fuels;
       (12) the establishment of such a vehicle fleet and 
     distribution system would provide a large market that would 
     mobilize private resources to substantially advance the 
     technology and expand the production of alcohol fuels in the 
     United States and abroad;
       (13) the United States has an urgent national security 
     interest to develop alcohol fuels technology, production, and 
     distribution systems as rapidly as possible;
       (14) new cars sold in the United States that are equipped 
     with an internal combustion engine should allow for fuel 
     competition by being flexible fuel vehicles, and new diesel 
     cars should be capable of operating on biodiesel; and
       (15) such an open fuel standard would help to protect the 
     United States economy from high and volatile oil prices and 
     from the threats caused by global instability, terrorism, and 
     natural disaster.
       (c) Open Fuel Standard for Transportation.--
       (1) In general.--Chapter 329 of title 49, United States 
     Code, is amended by adding at the end the following:

     ``Sec. 32920. Open fuel standard for transportation

       ``(a) Definitions.--In this section:
       ``(1) E85.--The term `E85' means a fuel mixture containing 
     85 percent ethanol and 15 percent gasoline by volume.
       ``(2) Flexible fuel automobile.--The term `flexible fuel 
     automobile' means an automobile that has been warranted by 
     its manufacturer to operate on gasoline, E85, and M85.
       ``(3) Fuel choice-enabling automobile.--The term `fuel 
     choice-enabling automobile' means--
       ``(A) a flexible fuel automobile; or
       ``(B) an automobile that has been warranted by its 
     manufacturer to operate on biodiesel.
       ``(4) Light-duty automobile.--The term `light-duty 
     automobile' means--
       ``(A) a passenger automobile; or
       ``(B) a non-passenger automobile.
       ``(5) Light-duty automobile manufacturer's annual covered 
     inventory.--The term `light-duty automobile manufacturer's 
     annual covered inventory' means the number of light-duty 
     automobiles powered by an internal combustion engine that a 
     manufacturer, during a given calendar year, manufactures in 
     the United States or imports from outside of the United 
     States for sale in the United States.
       ``(6) M85.--The term `M85' means a fuel mixture containing 
     85 percent methanol and 15 percent gasoline by volume.
       ``(b) Open Fuel Standard for Transportation.--
       ``(1) In general.--Except as provided in paragraph (2), 
     each light-duty automobile manufacturer's annual covered 
     inventory shall be comprised of--
       ``(A) not less than 50 percent fuel choice-enabling 
     automobiles in 2012, 2013, and 2014; and
       ``(B) not less than 80 percent fuel choice-enabling 
     automobiles in 2015, and in each subsequent year.
       ``(2) Temporary exemption from requirements.--
       ``(A) Application.--A manufacturer may request an exemption 
     from the requirement described in paragraph (1) by submitting 
     an application to the Secretary, at such time, in such 
     manner, and containing such information as the Secretary may 
     require by regulation. Each such application shall specify 
     the models, lines, and types of automobiles affected.
       ``(B) Evaluation.--After evaluating an application received 
     from a manufacturer, the Secretary may at any time, under 
     such terms and conditions, and to such extent as the 
     Secretary considers appropriate, temporarily exempt, or renew 
     the exemption of, a light-duty automobile from the 
     requirement described in paragraph (1) if the Secretary 
     determines that unavoidable events that are not under the 
     control of the manufacturer prevent the manufacturer of such 
     automobile from meeting its required production volume of 
     fuel choice-enabling automobiles, including--
       ``(i) a disruption in the supply of any component required 
     for compliance with the regulations;
       ``(ii) a disruption in the use and installation by the 
     manufacturer of such component; or
       ``(iii) the failure for plug-in hybrid electric automobiles 
     to meet State air quality requirements as a result of the 
     requirement described in paragraph (1).
       ``(C) Consolidation.--The Secretary may consolidate 
     applications received from multiple manufactures under 
     subparagraph (A) if they are of a similar nature.
       ``(D) Conditions.--Any exemption granted under subparagraph 
     (B) shall be conditioned upon the manufacturer's commitment 
     to recall the exempted automobiles for installation of the 
     omitted components within a reasonable time proposed by the 
     manufacturer and approved by the Secretary after such 
     components become available in sufficient quantities to 
     satisfy both anticipated production and recall volume 
     requirements.
       ``(E) Notice.--The Secretary shall publish in the Federal 
     Register--
       ``(i) notice of each application received from a 
     manufacturer;
       ``(ii) notice of each decision to grant or deny a temporary 
     exemption; and
       ``(iii) the reasons for granting or denying such 
     exemptions.
       ``(c) Limited Liability Protection for Renewable Fuel and 
     Ethanol Manufacture, Use, or Distribution.--
       ``(1) In general.--Notwithstanding any other provision of 
     Federal or State law, any fuel containing ethanol or a 
     renewable fuel (as defined in section 211(o)(1) of the Clean 
     Air Act) that is used or intended to be used to operate an 
     internal combustion engine shall not be deemed to be a 
     defective product or subject to a failure to warn due to such 
     ethanol or renewable fuel content unless such fuel violates a 
     control or prohibition imposed by the Administrator under 
     section 211 of the Clean Air Act (42 U.S.C. 7545).
       ``(2) Savings provision.--Nothing in this subsection may be 
     construed to affect the liability of any person other than 
     liability based upon a claim of defective product and failure 
     to warn described in paragraph (1).
       ``(d) Rulemaking.--Not later than 1 year after the date of 
     the enactment of this section, the Secretary of 
     Transportation shall promulgate regulations to carry out this 
     section.''.
       (2) Clerical amendment.--The table of sections for chapter 
     329 of title 49, United States Code, is amended by adding at 
     the end the following:

``32920. Open fuel standard for transportation.''.
                                 ______
                                 
  SA 3638. Ms. COLLINS proposed an amendment to the bill H.R. 4872, to 
provide for reconciliation pursuant to Title II of the concurrent 
resolution on the budget for fiscal year 2010 (S. Con. Res. 13); as 
follows:

       At the end of section 1003, add the following:
       (e) Unemployed Individual Not Taken Into Account.--
     Paragraph (5) of section 4980H(d) of the Internal Revenue 
     Code of 1986, as added by the Patient Protection and 
     Affordable Care Act, is amended by adding at the end the 
     following new subparagraph:
       ``(C) Exception for previously unemployed individuals.--
       ``(i) In general.--The term `full-time employee' shall not 
     include any individual who certifies by signed affidavit, 
     under penalties of perjury, that such individual has not been 
     employed from more than 40 hours during the 60-day period 
     ending on the date such individual begins such employment.
       ``(ii) Exception for replacement workers.--Clause (i) shall 
     not apply to an individual who is employed by the employer to 
     replace another employee of such employer unless such other 
     employee separated from employment voluntarily or for 
     cause.''.
                                 ______
                                 
  SA 3639. Mr. THUNE proposed an amendment to the bill H.R. 4872, to 
provide for reconciliation pursuant to Title II of the concurrent 
resolution on the budget for fiscal year 2010 (S. Con. Res. 13); as 
follows:


[[Page 4908]]

       Beginning on page 123, strike line 10 and all that follows 
     through page 124, line 10, and insert the following:

     SEC. 2201. TERMINATION OF FEDERAL FAMILY EDUCATION LOAN 
                   APPROPRIATIONS.

       Section 421 (20 U.S.C. 1071) is amended--
       (1) in subsection (b), in the first sentence of the matter 
     following paragraph (6), by inserting ``, except that no sums 
     may be expended after June 30, 2010, with respect to loans 
     under this part for which the first disbursement is after 
     such date if the Secretary certifies that no State will 
     experience a net job loss as a result of the enactment of the 
     SAFRA Act'' after ``expended''; and
       (2) by adding at the end the following new subsection:
       ``(d) Termination of Authority to Make or Insure New 
     Loans.--Notwithstanding paragraphs (1) through (6) of 
     subsection (b) or any other provision of law--
       ``(1) no new loans (including consolidation loans) may be 
     made or insured under this part after June 30, 2010 if the 
     Secretary certifies that no State will experience a net job 
     loss as a result of the enactment of the SAFRA Act; and
       ``(2) no funds are authorized to be appropriated, or may be 
     expended, under this Act or any other Act to make or insure 
     loans under this part (including consolidation loans) for 
     which the first disbursement is after June 30, 2010 if the 
     Secretary certifies that no State will experience a net job 
     loss as a result of the enactment of the SAFRA Act,

     except as expressly authorized by an Act of Congress enacted 
     after the date of enactment of the SAFRA Act.''.
                                 ______
                                 
  SA 3640. Mr. THUNE (for himself, Mr. Coburn, and Mr. Crapo) proposed 
an amendment to the bill H.R. 4872, to provide for reconciliation 
pursuant to Title II of the concurrent resolution on the budget for 
fiscal year 2010 (S. Con. Res. 13); as follows:

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

     SEC. 2304. REPEAL OF THE CLASS ACT.

       Title VIII of the Patient Protection and Affordable Care 
     Act and the amendments made by that title are repealed.
                                 ______
                                 
  SA 3641. Mr. DeMINT submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. SECRET BALLOT PROTECTION.

       (a) Short Title.--This section may be cited as the ``Secret 
     Ballot Protection Act of 2010''.
       (b) Findings.--Congress makes the following findings:
       (1) The right of employees under the National Labor 
     Relations Act (29 U.S.C. 151 et seq.) to choose whether to be 
     represented by a labor organization by way of secret ballot 
     election conducted by the National Labor Relations Board is 
     among the most important protections afforded under Federal 
     labor law.
       (2) The right of employees to choose by secret ballot is 
     the only method that ensures a choice free of coercion, 
     intimidation, irregularity, or illegality.
       (3) The recognition of a labor organization by using a 
     private agreement, rather than a secret ballot election 
     overseen by the National Labor Relations Board, threatens the 
     freedom of employees to choose whether to be represented by a 
     labor organization, and severely limits the ability of the 
     National Labor Relations Board to ensure the protection of 
     workers.
       (c) National Labor Relations Act.--
       (1) Recognition of representative.--
       (A) In general.--Section 8(a)(2) of the National Labor 
     Relations Act (29 U.S.C. 158(a)(2)) is amended by inserting 
     before the colon the following: ``or to recognize or bargain 
     collectively with a labor organization that has not been 
     selected by a majority of such employees in a secret ballot 
     election conducted by the Board in accordance with section 
     9''.
       (B) Application.--The amendment made by subparagraph (A) 
     shall not apply to collective bargaining relationships in 
     which a labor organization with majority support was lawfully 
     recognized prior to the date of enactment of this Act.
       (2) Election required.--
       (A) In general.--Section 8(b) of the National Labor 
     Relations Act (29 U.S.C. 158(b)) is amended--
       (i) in paragraph (6), by striking ``and'' at the end;
       (ii) in paragraph (7), by striking the period at the end 
     and inserting ``; and''; and
       (iii) by adding at the end the following:
       ``(8) to cause or attempt to cause an employer to recognize 
     or bargain collectively with a representative of a labor 
     organization that has not been selected by a majority of such 
     employees in a secret ballot election conducted by the Board 
     in accordance with section 9.''.
       (B) Application.--The amendment made by subparagraph (A) 
     shall not apply to collective bargaining relationships that 
     were recognized prior to the date of enactment of this Act.
       (3) Secret ballot election.--Section 9(a) of the National 
     Labor Relations Act (29 U.S.C. 159(a)) is amended--
       (A) by striking ``Representatives'' and inserting ``(1) 
     Representatives'';
       (B) by inserting after ``designated or selected'' the 
     following: ``by a secret ballot election conducted by the 
     Board in accordance with this section''; and
       (C) by adding at the end the following:
       ``(2) The secret ballot election requirement under 
     paragraph (1) shall not apply to collective bargaining 
     relationships that were recognized before the date of the 
     enactment of the Health Care and Education Reconciliation Act 
     of 2010.''.
       (d) Regulations and Authority.--
       (1) Regulations.--Not later than 6 months after the date of 
     enactment of this Act, the National Labor Relations Board 
     shall review and revise all regulations promulgated prior to 
     such date of enactment to implement the amendments made by 
     this section.
       (2) Authority.--Nothing in this section (or the amendments 
     made by this section) shall be construed to limit or 
     otherwise diminish the remedial authority of the National 
     Labor Relations Board.
                                 ______
                                 
  SA 3642. Mr. DeMINT submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

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

     SEC. __. ALLOWING INDIVIDUALS TO CHOOSE TO OPT OUT OF THE 
                   MEDICARE PART A BENEFIT.

       Notwithstanding any other provision of law, in the case of 
     an individual who elects to opt-out of benefits under part A 
     of title XVIII of the Social Security Act, such individual 
     shall not be required to--
       (1) opt-out of benefits under title II of such Act as a 
     condition for making such election; and
       (2) repay any amount paid under such part A for items and 
     services furnished prior to making such election.
                                 ______
                                 
  SA 3643. Ms. MURKOWSKI submitted an amendment intended to be proposed 
by her to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle B of title I, insert the following:

     SEC. __. ALLOWING INDIVIDUALS TO CHOOSE TO OPT OUT OF THE 
                   MEDICARE PART A BENEFIT.

       Notwithstanding any other provision of law, in the case of 
     an individual who elects to opt-out of benefits under part A 
     of title XVIII of the Social Security Act, such individual 
     shall not be required to--
       (1) opt-out of benefits under title II of such Act as a 
     condition for making such election; and
       (2) repay any amount paid under such part A for items and 
     services furnished prior to making such election.
                                 ______
                                 
  SA 3644. Mr. HATCH (for himself, Mr. Coburn, and Mr. Crapo) proposed 
an amendment to the bill H.R. 4872, to provide for reconciliation 
pursuant to Title II of the concurrent resolution on the budget for 
fiscal year 2010 (S. Con. Res. 13); as follows:

       On page 99, between lines 9 and 10, insert the following:
       (e) Exclusion of Medical Devices Sold Under the TRICARE for 
     Life Program or Veteran's Health Care Programs.--
       (1) In general.--For purposes of section 4191(b)(1) of the 
     Internal Revenue Code of 1986, as added by subsection (a), 
     the term ``taxable medical device'' shall not include any 
     device which is sold to individuals covered under the TRICARE 
     for Life program or the veteran's health care program under 
     chapter 17 of title 38, United States Code, any portion of 
     the cost of which is paid or reimbursed under either such 
     program.
       (2) Expansion of affordability exception to individual 
     mandate.--Section 5000A(e)(1)(A) of the Internal Revenue Code 
     of 1986, as added by section 1501(b) of the Patient 
     Protection and Affordable Care Act and amended by section 
     10106 of such Act, is amended by striking ``8 percent'' and 
     inserting ``5 percent''.
       (3) Application of provision.--The amendment made by 
     paragraph (2) shall apply as if included in the Patient 
     Protection and Affordable Care Act.
                                 ______
                                 
  SA 3645. Mr. RISCH (for himself and Mr. Crapo) submitted an amendment 
intended to be proposed by him to the bill H.R. 4872, to provide for 
reconciliation pursuant to Title II of the concurrent resolution on the 
budget for

[[Page 4909]]

fiscal year 2010 (S. Con. Res. 13); as follows:

       At the end of subtitle E of title I, insert the following:

     SECTION--.REPEAL OF LIMITATION ON ITEMIZED DEDUCTIONS FOR 
                   MEDICAL EXPENSES.

       (a) In General.--Section 9013 of the Patient Protection and 
     Affordable Care Act is hereby repealed effective as of the 
     date of the enactment of such Act and any provisions of law 
     amended by such section are amended to read as such 
     provisions would read if such section had never been enacted.
       (b) Expansion of Affordability Exception to Individual 
     Mandate.--Section 5000A(e)(1)(A) of the Internal Revenue Code 
     of 1986, as added by section 1501(b) of the Patient 
     Protection and Affordable Care Act and amended by section 
     10106 of such Act, is amended by striking ``8 percent'' and 
     inserting ``5 percent''.
       (c) Application of Provision.--The amendment made by 
     subsection (b) shall apply as if included in the Patient 
     Protection and Affordable Care Act.
                                 ______
                                 
  SA 3646. Mr. RISCH submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

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

     SEC. 1207. REQUIREMENT FOR ALL MEDICAID AND CHIP APPLICANTS 
                   TO PRESENT AN IDENTIFICATION DOCUMENT.

       (a) In General.--Section 1902 of the Social Security Act 
     (42 U.S.C. 1396a), as amended by section 211(a)(1)(A)(i) of 
     Public Law 111-3, section 2303(a)(2) of the Patient 
     Protection and Affordable Care Act, and section 1202 of this 
     Act, is amended--
       (1) in subsection (a)(46), --
       (A) in subparagraph (A), by striking ``and'' after the 
     semicolon;
       (B) in subparagraph (B), by adding ``and'' after the 
     semicolon; and
       (C) by adding at the end the following:
       ``(C) provide that each applicant for medical assistance 
     (or the parent or guardian of an applicant who has not 
     attained age 18), regardless of whether the applicant is 
     described in paragraph (2) of section 1903(x), shall present 
     an identification document described in subsection (kk) when 
     applying for medical assistance (and shall be provided with 
     at least the reasonable opportunity to present such 
     identification as is provided under clauses (i) and (ii) of 
     section 1137(d)(4)(A) to an individual for the submittal to 
     the State of evidence indicating a satisfactory immigration 
     status;''; and
       (2) by adding at the end the following:
       ``(kk) For purposes of subsection (a)(46)(C), a document 
     described in this subsection is--
       ``(1) in the case of an individual who is a national of the 
     United States--
       ``(A) a United States passport, or passport card issued 
     pursuant to the Secretary of State's authority under the 
     first section of the Act of July 3, 1926 (44 Stat. 887, 
     Chapter 772; 22 U.S.C. 211a); or
       ``(B) a driver's license or identity card issued by a 
     State, the Commonwealth of the Northern Mariana Islands, or 
     an outlying possession of the United States that--
       ``(i) contains a photograph of the individual and other 
     identifying information, including the individual's name, 
     date of birth, gender, and address; and
       ``(ii) contains security features to make the license or 
     card resistant to tampering, counterfeiting, and fraudulent 
     use;
       ``(2) in the case of an alien lawfully admitted for 
     permanent residence in the United States, a permanent 
     resident card, as specified by the Secretary of Homeland 
     Security that meets the requirements of clauses (i) and (ii) 
     of paragraph (1)(B);
       ``(3) in the case of an alien who is authorized to be 
     employed in the United States, an employment authorization 
     card, as specified by the Secretary of Homeland Security that 
     meets the requirements of clauses (i) and (ii) of paragraph 
     (1)(B); or
       ``(4) in the case of an individual who is unable to obtain 
     a document described in paragraph (1), (2), or (3), a 
     document designated by the Secretary of Homeland Security 
     that meets the requirements of clauses (i) and (ii) of 
     paragraph (1)(B).''.
       (b) Application to CHIP.--Section 2105(c)(9)(A) (42 U.S.C. 
     1397ee(c)(9)(A)) is amended by striking ``section 
     1902(a)(46)(B)'' and inserting ``subparagraphs (B) and (C) of 
     subsection (a)(46) and subsection (kk) of section 1902''.
                                 ______
                                 
  SA 3647. Mr. COLLINS submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

       At the end of section 1001, insert the following:
       (c) Bereavement Exception in Determining Family Size.--
       (1) In general.--Section 36B(d)(1) of the Internal Revenue 
     Code of 1986, as added by section 1401 of the Patient 
     Protection and Affordable Care Act and amended by section 
     10105 of such Act is amended by adding at the end the 
     following new sentence: ``If an individual taken into account 
     under the preceding sentence for any taxable year dies during 
     such taxable year, such individual shall be taken into 
     account in determining family size for the following taxable 
     year unless the family size for the taxable year of death was 
     only one.''
       (2) Effective date.--The amendment made by this section 
     shall take effect as if included in the provision of the 
     Patient Protection and Affordable Care Act to which the 
     amendment relates.
                                 ______
                                 
  SA 3648. Mr. COBURN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

       On page 144, between lines 2 and 3, insert the following:

     SEC. 2214. DIRECT LOAN ORIGINATION FEE REDETERMINATION.

       Notwithstanding section 455(c) of the Higher Education Act 
     of 1965 (20 U.S.C. 1087e(c)), the Secretary of Education 
     shall determine under such section an increase to the 
     origination fee charged to a borrower of a loan made under 
     part D of title IV of such Act (20 U.S.C. 1087a et seq.) for 
     the subsequent award year to take into account any increase 
     in actual program costs for the Federal Direct Loan Program 
     under such part D, as determined by the Office of Management 
     and Budget in the program re-estimate contained in the 
     President's current fiscal year budget.
                                 ______
                                 
  SA 3649. Mr. COBURN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

       On page 144, between lines 2 and 3, insert the following:

     SEC. 2214. QUALIFICATION REQUIREMENT FOR DEPARTMENT OF 
                   EDUCATION STAFF.

       Not later than 6 years after the date of enactment of this 
     Act, each employee of the Department of Education Office of 
     Federal Student Aid shall become highly qualified in fiscal 
     management by earning a bachelor's degree in finance or 
     business management/administration.
                                 ______
                                 
  SA 3650. Mr. COBURN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

       On page 144, between lines 2 and 3, insert the following:

     SEC. 2214. REDUCTION OF FEDERAL PELL GRANT ADD ON.

       Notwithstanding any other provision of law, the additional 
     funds amount provided under section 401(b)(8) of the Higher 
     Education Act of 1965 (20 U.S.C. 1070a(b)(8)) for Federal 
     Pell Grants for a fiscal year shall be reduced for such 
     fiscal year by the amount that reflects any increase in 
     actual program costs for the Federal Direct Loan Program 
     under part D of title IV of the Higher Education Act of 1965 
     (20 U.S.C. 1087a et seq.), as determined by the Office of 
     Management and Budget in the program re-estimate contained in 
     the President's current fiscal year budget.
                                 ______
                                 
  SA 3651. Mr. GREGG proposed an amendment to the bill H.R. 4872, to 
provide for reconciliation pursuant to Title II of the concurrent 
resolution on the budget for fiscal year 2010 (S. Con. Res. 13); as 
follows:

       On page 61, between lines 3 and 4, insert the following:

     SEC. __. INCREASE IN THE MEDICARE PHYSICIAN PAYMENT UPDATE 
                   FOR THE LAST 9 MONTHS OF 2010 AND ALL OF 2011 
                   THROUGH 2013.

       Paragraph (1) of section 1848(d) of the Social Security 
     Act, as added by section 1011(a) of the Department of Defense 
     Appropriations Act, 2010 (Public Law 111-118) and as amended 
     by section 5 of the Temporary Extension Act of 2010 (Public 
     Law 111-144), is amended to read as follows:
       ``(10) Update for 2010 through 2013.--
       ``(A) In general.--Subject to paragraphs (7)(B), (8)(B), 
     and (9)(B), in lieu of the update to the single conversion 
     factor established in paragraph (1)(C) that would otherwise 
     apply for each of 2010, 2011, 2012, and 2013, the update to 
     the single conversion factor shall be 0 percent for such 
     years.
       ``(B) No effect on computation of conversion factor for 
     2014 and subsequent years.--The conversion factor under this 
     subsection shall be computed under paragraph (1)(A) for 2014 
     and subsequent years as if subparagraph (A) had never 
     applied.''.
                                 ______
                                 
  SA 3652. Mr. BURR (for himself, Mr. Graham, Mr. Crapo, Mr. Barrasso,

[[Page 4910]]

Mr. McCain and Mr. Brown of Massachusetts) proposed an amendment to the 
bill H.R. 4872, to provide for reconciliation pursuant to Title II of 
the concurrent resolution on the budget for fiscal year 2010 (S. Con. 
Res. 13); as follows:

       At the end of subtitle F of title I, insert the following:

     SEC. 1__. TREATMENT OF DEPARTMENT OF VETERANS AFFAIRS AND 
                   DEPARTMENT OF DEFENSE HEALTH PROGRAMS.

       Subtitle G of title I of the Patient Protection and 
     Affordable Care Act is amended by adding at the end the 
     following new section:

     ``SEC. 1564. DEPARTMENT OF VETERANS AFFAIRS AND DEPARTMENT OF 
                   DEFENSE HEALTH PROGRAMS.

       ``(a) Clarifications With Respect to Certain Programs and 
     Authorities.--Nothing in this Act or in the amendments made 
     by this Act shall be construed as affecting any of the 
     following:
       ``(1) Any authority under title 38, United States Code.
       ``(2) Any authority under chapter 55 of title 10, United 
     States Code.
       ``(3) Any health care or health care benefit provided under 
     the TRICARE program under chapter 55 of title 10, United 
     States Code, or by the Secretary of Veterans Affairs under 
     the laws administered by such Secretary.
       ``(b) Clarification With Respect to Minimum Essential 
     Coverage.--For purposes of this Act and the amendments made 
     by this Act, the term `minimum essential coverage' includes 
     the following:
       ``(1) Coverage provided under chapter 55 of title 10, 
     United States Code.
       ``(2) Eligibility for health care provided by the Secretary 
     of Veterans Affairs under title 38, United States Code.''.
                                 ______
                                 
  SA 3653. Mr. BROWNBACK submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

       At the end of subtitle F of title I, add the following:

     SEC. 15__. RENEWABLE FUEL.

       (a) Definition of Renewable Fuel.--Section 211(o)(1)(J) of 
     the Clean Air Act (42 U.S.C. 7545(o)(1)(J)) is amended by 
     striking ``fuel that is produced'' and inserting ``a blend of 
     fuel at least 85 percent of the content of which is 
     derived''.
       (b) Liability Protection for Renewable Fuel or Ethanol 
     Manufacture, Use, or Distribution.--
       (1) In general.--Section 211(o) of the Clean Air Act (42 
     U.S.C. 7545(o)) is amended by adding at the end the 
     following:
       ``(13) Liability protection for renewable fuel or ethanol 
     manufacture, use, or distribution.--
       ``(A) In general.--Notwithstanding any other provision of 
     Federal or State law, no renewable fuel or ethanol used or 
     intended to be used as a motor vehicle fuel, nor any motor 
     vehicle fuel containing renewable fuel or ethanol, shall be 
     considered a defective product or subject to a failure to 
     warn by virtue of the fact that the renewable fuel or ethanol 
     is, or contains, the renewable fuel or ethanol, if the 
     renewable fuel or ethanol does not violate a control or 
     prohibition imposed by the Administrator under this section.
       ``(B) Effect on liability.--Nothing in this paragraph 
     affects the liability of any person other than liability 
     based on a claim of a defective product and failure to warn 
     of the defect.''.
       (2) Effective date; application.--The amendment made by 
     paragraph (1) shall--
       (A) be effective on the earlier of--
       (i) the date of enactment of this Act; or
       (ii) the date on which the Administrator of the 
     Environmental Protection Agency approves for use fuel blends 
     with greater than 10 percent ethanol by volume; and
       (B) apply with respect to all claims filed on or after the 
     earlier date described in subparagraph (A).
                                 ______
                                 
  SA 3654. Mr. BARRASSO submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

       At the end of subtitle A of title I, add the following:

     SEC. 1006. SUNSET IF PREMIUMS INCREASE TOO RAPIDLY.

       (a) In General.--The following requirements of the Patient 
     Protection and Affordable Care Act shall not apply to health 
     insurance coverage and group health plans offered in the 
     individual or group market within a State during plan years 
     beginning after the sunset date with respect to that market:
       (1) Any requirement under section 1301 of such Act, section 
     2707 of the Public Health Service Act, or any other provision 
     of, or amendment made by, such Act that a health plan provide 
     an essential health benefits package described in section 
     1302(a) of such Act, including any requirement that the plan 
     provide--
       (A) for essential health benefits described in section 
     1302(b) of such Act;
       (B) in the case of a plan offered in the group market, an 
     annual limitation on the plan's deductible described in 
     section 1302(c)(2) of such Act; and
       (C) a level of coverage described in section 1302(d) of 
     such Act.
       (2) The requirements of section 2701 of the Public Health 
     Service Act (relating to limits on premiums).
       (b) Coordination With Qualified Health Plans and Premium 
     Tax Credits and Cost-Sharing Reductions.--In the case of a 
     State to which subsection (a) applies, the Secretary of 
     health and Human Services shall establish procedures for 
     establishing which health plans shall be treated as qualified 
     health plans for purposes of the Exchanges established within 
     such State. Such procedures shall ensure that the aggregate 
     amount of premium tax credits under section 36B of the 
     Internal Revenue Code of 1986 and cost-sharing reductions 
     under section 1402 of the Patient Protection and Affordable 
     Care Act with respect to qualified health plans in the 
     individual market within such State does not exceed the 
     aggregate amount of such credits and reductions that would 
     have been allowed if subsection (a) did not apply to such 
     State.
       (c) Sunset Date.--For purposes of this section--
       (1) In general.--The term ``sunset date'' means, with 
     respect to the individual or group market within a State, the 
     first date on which the applicable State authority determines 
     under paragraph (2) that the percentage increase in average 
     annual premiums within such market for a calendar year over 
     the preceding calendar year exceeds the percentage increase 
     for such period in the Consumer Price Index for all urban 
     consumers published by the Department of Labor.
       (2) Determination.--The applicable State authority shall 
     for each calendar year after 2013 make the determination 
     described in paragraph (1).
       (3) Applicable state authority.--The term ``applicable 
     State authority'' has the meaning given such term by section 
     2791(d)(1) of the Public Health Service Act.
                                 ______
                                 
  SA 3655. Mr. BARRASSO submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

       In subtitle A of title I, add at the end the following:

     SEC. 1__. EXEMPTION FROM MANDATE.

       Section 5000A of the Internal Revenue Code of 1986, as 
     added by section 1501(b) of the Patient Protection and 
     Affordable Care Act, is amended--
       (1) by redesignating subsection (g) as subsection (h); and
       (2) by inserting after subsection (f), the following:
       ``(g) Limitation.--This section shall not apply to an 
     individual for a taxable year if such individual--
       ``(1) in under 30 years of age when such year begins; or
       ``(2) has a modified gross income that does not exceed 
     $30,000 for such year.''.
                                 ______
                                 
  SA 3656. Mr. BARRASSO submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

       At the end of section 1002, insert the following:
       (c) High Deductible Health Plans Treated as Minimum 
     Essential Coverage.--Section 5000A(f) of the Internal Revenue 
     Code of 1986, as so added and amended, is amended by 
     redesignating paragraph (5) as paragraph (6) and by inserting 
     after paragraph (4) the following:
       ``(5) High deductible health plan.--
       ``(A) In general.--If an applicable individual--
       ``(i) is an employee of an employer who ceases to offer the 
     employee the opportunity to enroll in an eligible employer-
     sponsored plan, or
       ``(ii) ceases employment with an employer and is not 
     otherwise eligible to enroll in an eligible employer-
     sponsored plan,
     the applicable individual may enroll in a high deductible 
     health plan described in subparagraph (C) and such plan shall 
     be treated as minimum essential coverage.
       ``(B) Continued enrollment.--If an individual described in 
     subparagraph (A) enrolls in a high deductible health plan 
     described in subparagraph (C), such plan shall continue to be 
     treated as minimum essential coverage with respect to that 
     individual during any continuous period of enrollment even if 
     the individual is otherwise eligible to enroll in an eligible 
     employer-sponsored plan.
       ``(C) Plan described.--A health plan is described in this 
     subparagraph if it is a high deductible health plan (as 
     defined in section 223(c)(2)) that meets all requirements 
     under such section to be offered in connection with

[[Page 4911]]

     a health savings account. No requirement imposed by any 
     provision of, or any amendment made by, the Patient 
     Protection and Affordable Care Act shall apply with respect 
     to the plan or issuer thereof.''.
                                 ______
                                 
  SA 3657. Mr. BARRASSO submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

       At the end of section 1002, insert the following:
       (c) Individual Mandate Penalties Credited to Individual 
     Accounts and Used for Premiums.--Section 5000A of the 
     Internal Revenue Code of 1986, as so added and amended, is 
     amended by adding at the end the following:
       ``(h) Penalties Credited to Individual Accounts and Used 
     for Premiums.--
       ``(1) In general.--The Secretary shall not later than 
     January 1, 2014, establish and implement a program under 
     which--
       ``(A) if a penalty has been imposed under this section with 
     respect to an applicable individual for months during any 
     calendar year, the Secretary--
       ``(i) establishes an account on behalf of the applicable 
     individual, and
       ``(ii) credits such account with an amount equal to the 
     amount of the penalty, and
       ``(B) if the applicable individual subsequently becomes 
     covered under minimum essential coverage for 1 or more 
     months, the Secretary pays to or on behalf of the applicable 
     individual an amount equal to the premiums paid by the 
     individual for such coverage (or, if lesser, the balance in 
     the account established under subparagraph (A)).
       ``(2) Amounts available only for 3 years.--
       ``(A) In general.--If an account is credited under 
     paragraph (1)(A) with an amount for any calendar year, such 
     amount shall be available for payment under paragraph (1)(B) 
     only for premiums for minimum essential coverage for months 
     occurring during the 3 calendar years immediately following 
     such calendar year.
       ``(B) Special rules.--For purposes of this subsection--
       ``(i) the Secretary need only establish 1 account for an 
     individual, and
       ``(ii) amounts shall be treated as paid out of an account 
     on a first-in, first-out basis.''.
                                 ______
                                 
  SA 3658. Mr. BARRASSO submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 61, between lines 3 and 4, insert the following:

     SEC. __. USE OF PRIVATE CONTRACTS BY MEDICARE BENEFICIARIES 
                   FOR PROFESSIONAL SERVICES.

       (a) In General.--Section 1802(b) of the Social Security Act 
     (42 U.S.C. 1395a) is amended to read as follows:
       ``(b) Clarification of Use of Private Contracts by Medicare 
     Beneficiaries for Professional Services.--
       ``(1) In general.--Nothing in this title shall prohibit a 
     medicare beneficiary from entering into a private contract 
     with a physician or health care practitioner for the 
     provision of medicare covered professional services (as 
     defined in paragraph (5)(C)) if--
       ``(A) the services are covered under a private contract 
     that is between the beneficiary and the physician or 
     practitioner and meets the requirements of paragraph (2);
       ``(B) under the private contract no claim for payment for 
     services covered under the contract is to be submitted (and 
     no payment made) under part A or B, under a contract under 
     section 1876, or under an MA plan (other than an MSA plan); 
     and
       ``(C)(i) the Secretary has been provided with the minimum 
     information necessary to avoid any payment under part A or B 
     for services covered under the contract, or
       ``(ii) in the case of an individual enrolled under a 
     contract under section 1876 or an MA plan (other than an MSA 
     plan) under part C, the eligible organization under the 
     contract or the MA organization offering the plan has been 
     provided the minimum information necessary to avoid any 
     payment under such contract or plan for services covered 
     under the contract.
       ``(2) Requirements for private contracts.--The requirements 
     in this paragraph for a private contract between a medicare 
     beneficiary and a physician or health care practitioner are 
     as follows:
       ``(A) General form of contract.--The contract is in writing 
     and is signed by the medicare beneficiary.
       ``(B) No claims to be submitted for covered services.--The 
     contract provides that no party to the contract (and no 
     entity on behalf of any party to the contract) shall submit 
     any claim for (or request) payment for services covered under 
     the contract under part A or B, under a contract under 
     section 1876, or under an MA plan (other than an MSA plan).
       ``(C) Scope of services.--The contract identifies the 
     medicare covered professional services and the period (if 
     any) to be covered under the contract, but does not cover any 
     services furnished--
       ``(i) before the contract is entered into; or
       ``(ii) for the treatment of an emergency medical condition 
     (as defined in section 1867(e)(1)(A)), unless the contract 
     was entered into before the onset of the emergency medical 
     condition.
       ``(D) Clear disclosure of terms.--The contract clearly 
     indicates that by signing the contract the medicare 
     beneficiary--
       ``(i) agrees not to submit a claim (or to request that 
     anyone submit a claim) under part A or B (or under section 
     1876 or under an MA plan, other than an MSA plan) for 
     services covered under the contract;
       ``(ii) agrees to be responsible, whether through insurance 
     or otherwise, for payment for such services and understands 
     that no reimbursement will be provided under such part, 
     contract, or plan for such services;
       ``(iii) acknowledges that no limits under this title 
     (including limits under paragraphs (1) and (3) of section 
     1848(g)) will apply to amounts that may be charged for such 
     services;
       ``(iv) acknowledges that medicare supplemental policies 
     under section 1882 do not, and other supplemental health 
     plans and policies may elect not to, make payments for such 
     services because payment is not made under this title; and
       ``(v) acknowledges that the beneficiary has the right to 
     have such services provided by (or under the supervision of) 
     other physicians or health care practitioners for whom 
     payment would be made under such part, contract, or plan.

     Such contract shall also clearly indicate whether the 
     physician or practitioner involved is excluded from 
     participation under this title.
       ``(3) Modifications.--The parties to a private contract may 
     mutually agree at any time to modify or terminate the 
     contract on a prospective basis, consistent with the 
     provisions of paragraphs (1) and (2).
       ``(4) No requirements for services furnished to msa plan 
     enrollees.--The requirements of paragraphs (1) and (2) do not 
     apply to any contract or arrangement for the provision of 
     services to a medicare beneficiary enrolled in an MSA plan 
     under part C.
       ``(5) Definitions.--In this subsection:
       ``(A) Health care practitioner.--The term `health care 
     practitioner' means a practitioner described in section 
     1842(b)(18)(C).
       ``(B) Medicare beneficiary.--The term `medicare 
     beneficiary' means an individual who is enrolled under part 
     B.
       ``(C) Medicare covered professional services.--The term 
     `medicare covered professional services' means--
       ``(i) physicians' services (as defined in section 1861(q), 
     and including services described in section 1861(s)(2)(A)), 
     and
       ``(ii) professional services of health care practitioners, 
     including services described in section 1842(b)(18)(D),

     for which payment may be made under part A or B, under a 
     contract under section 1876, or under a Medicare Advantage 
     plan but for the provisions of a private contract that meets 
     the requirements of paragraph (2).
       ``(D) MA plan; msa plan.--The terms `MA plan' and `MSA 
     plan' have the meanings given such terms in section 1859.
       ``(E) Physician.--The term `physician' has the meaning 
     given such term in section 1861(r).''.
       (b) Conforming Amendments Clarifying Exemption From 
     Limiting Charge and From Requirement for Submission of 
     Claims.--Section 1848(g) of the Social Security Act (42 
     U.S.C. 1395w-4(g)) is amended--
       (1) in paragraph (1)(A), by striking ``In'' and inserting 
     ``Subject to paragraph (8), in'';
       (2) in paragraph (3)(A), by striking ``Payment'' and 
     inserting ``Subject to paragraph (8), payment'';
       (3) in paragraph (4)(A), by striking ``For'' and inserting 
     ``Subject to paragraph (8), for''; and
       (4) by adding at the end the following new paragraph:
       ``(8) Exemption from requirements for services furnished 
     under private contracts.--
       ``(A) In general.--Pursuant to section 1802(b)(1), 
     paragraphs (1), (3), and (4) do not apply with respect to 
     physicians' services (and services described in section 
     1861(s)(2)(A)) furnished to an individual by (or under the 
     supervision of) a physician if the conditions described in 
     section 1802(b)(1) are met with respect to the services.
       ``(B) No restrictions for enrollees in msa plans.--Such 
     paragraphs do not apply with respect to services furnished to 
     individuals enrolled with MSA plans under part C, without 
     regard to whether the conditions described in subparagraphs 
     (A) through (C) of section 1802(b)(1) are met.
       ``(C) Application to enrollees in other plans.--Subject to 
     subparagraph (B) and section 1852(k)(2), the provisions of 
     subparagraph (A) shall apply in the case of an individual 
     enrolled under a contract under section 1876 or under an MA 
     plan (other than an MSA plan) under part C, in the same 
     manner as they apply to individuals not enrolled under such a 
     contract or plan.''.

[[Page 4912]]

       (c) Conforming Amendments.--(1) Section 1842(b)(18) of the 
     Social Security Act (42 U.S.C. 1395u(b)(18)) is amended by 
     adding at the end the following:
       ``(E) The provisions of section 1848(g)(8) shall apply with 
     respect to exemption from limitations on charges and from 
     billing requirements for services of health care 
     practitioners described in this paragraph in the same manner 
     as such provisions apply to exemption from the requirements 
     referred to in section 1848(g)(8)(A) for physicians' 
     services.''.
       (2) Section 1866(a)(1)(O) of such Act (42 U.S.C. 
     1395cc(a)(1)(O)) is amended by striking ``enrolled with a 
     Medicare Advantage organization under part C'' and inserting 
     ``enrolled with an MA organization under part C (other than 
     under an MSA plan)''.
       (d) Effective Date.--The amendments made by this section 
     shall take effect on the date that is 6 months after the date 
     of the enactment of this Act and apply to contracts entered 
     into on or after that date.
                                 ______
                                 
  SA 3659. Mr. BARRASSO submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, insert the following:

     SEC. 1__. CONTINUED ABILITY TO PAY FOR HEALTH CARE.

       Title I of the Patient Protection and Affordable Care Act 
     is amended by adding at the end the following:

     ``SEC. 1564. CONTINUED ABILITY TO PAY FOR HEALTH CARE.

       ``Nothing in this title (or an amendment made by this 
     title) shall be construed to prohibit an individual from 
     purchasing or otherwise paying for health care items or 
     services on an out-of-pocket basis.''.
                                 ______
                                 
  SA 3660. Mr. BARRASSO submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, insert the following:

     SEC. 1__. PROTECTING THE TAXPAYERS.

       Title I of the Patient Protection and Affordable Care Act 
     is amended by adding at the end the following:

     ``SEC. 1564. PROTECTING THE TAXPAYERS.

       ``The provisions of this title (and the amendments made by 
     this title) shall not apply with respect to a fiscal year if 
     the Director of the Office of Management and Budget fails to 
     certify to Congress that the application of such provisions 
     (and amendments) in such fiscal year will not increase the 
     Federal budget deficit.''.
                                 ______
                                 
  SA 3661. Mr. BARRASSO submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       In subtitle A of title I, add at the end the following:

     SEC. 1__. EXEMPTION FROM MANDATE.

       Section 5000A of the Internal Revenue Code of 1986, as 
     added by section 1501(b) of the Patient Protection and 
     Affordable Care Act, is amended--
       (1) by redesignating subsection (g) as subsection (h); and
       (2) by inserting after subsection (f), the following:
       ``(g) Limitation.--This section shall not apply to an 
     individual for a taxable year if such individual--
       ``(1) in under 30 years of age when such year begins; or
       ``(2) has a modified gross income that does not exceed 
     $30,000 for such year.''.
                                 ______
                                 
  SA 3662. Mr. BARRASSO submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle E of title I, add the following:

     SEC. 14__. REPEAL OF ADDITIONAL TAX FROM DISTRIBUTIONS FROM 
                   HSAS AND MSAS.

       (a) HSAs.--Section 223(f)(4)(A) of the Internal Revenue 
     Code of 1986, as amended by section 9004 of the Patient 
     Protection and Affordable Care Act, is amended by striking 
     ``20 percent'' and inserting ``10 percent''.
       (b) Archer MSAs.--Section 220(f)(4)(A) of the Internal 
     Revenue Code of 1986, as amended by section 9004 of the 
     Patient Protection and Affordable Care Act, is amended by 
     striking ``20 percent'' and inserting ``15 percent''.
       (c) Effective Date.--The amendments made by this section 
     shall apply to distributions made after December 31, 2010.
                                 ______
                                 
  SA 3663. Mr. BARRASSO submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 56, between lines 20 and 21, insert the following:
       (f) Budget-Neutral Exemption of Certain Providers.--
     Notwithstanding the provisions of, and amendments made by, 
     the preceding subsections of this section and sections 3401 
     and 10319 of the Patient Protection and Affordable Care Act--
       (1) such provisions and amendments shall not apply to a 
     health care provider that--
       (A) is described in section 340B(a)(4) of the Public Health 
     Service Act or 1927(c)(1)(D)(i)(IV) of the Social Security 
     Act (42 U.S.C. 1396r-8(c)(1)(D)(i)(IV)); and
       (B) is located in an area that is not a metropolitan 
     statistical area (as determined by the Bureau of the Census); 
     and
       (2) the Secretary of Health and Human Services shall make 
     appropriate adjustments in the application of such provisions 
     and amendments to ensure that the amount of expenditures 
     under title XVIII of the Social Security Act is equal to the 
     amount of expenditures that would have been made under such 
     title if this subsection had not been enacted, as estimated 
     by the Secretary.
                                 ______
                                 
  SA 3664. Mr. VITTER submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, add the following:

     SEC. 1502. VERIFICATION OF IDENTITY.

       No individual may receive assistance of any kind provided 
     by the Federal Government to obtain health insurance coverage 
     unless the individual provides to the appropriate agency or 
     department of the Federal Government an appropriate 
     identification that was issued by a governmental entity and 
     that includes a photograph and the name, date of birth, and 
     social security number of the individual.
                                 ______
                                 
  SA 3665. Mr. VITTER submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle B of title I, insert the following:

     SEC. ___. SUSPENSION OF THE ACT.

       If at the beginning of any fiscal year OMB determines that 
     the deficit targets set forth in the CBO report of March 20, 
     2010 will not be met, the provisions of this Act and the 
     Patient Protection and Affordable Care Act shall be suspended 
     for that year.
                                 ______
                                 
  SA 3666. Mr. VITTER submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, add the following:

     SEC. 1502. ELIMINATION OF AUTOMATIC PAY ADJUSTMENTS FOR 
                   MEMBERS OF CONGRESS.

       (a) In General.--Paragraph (2) of section 601(a) of the 
     Legislative Reorganization Act of 1946 (2 U.S.C. 31) is 
     repealed.
       (b) Technical and Conforming Amendments.--Section 601(a)(1) 
     of such Act is amended--
       (1) by striking ``(a)(1)'' and inserting ``(a)'';
       (2) by redesignating subparagraphs (A), (B), and (C) as 
     paragraphs (1), (2), and (3), respectively; and
       (3) by striking ``as adjusted by paragraph (2) of this 
     subsection'' and inserting ``adjusted as provided by law''.
       (c) Effective Date.--This section shall take effect on 
     December 31, 2011.
                                 ______
                                 
  SA 3667. Mr. VITTER submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, add the following:

[[Page 4913]]



     SEC. 1502. ELIMINATION OF SPECIAL HEALTH CARE PRIVILEGES FOR 
                   MEMBERS OF CONGRESS.

       Section 1312(d)(3) of the Patient Protection and Affordable 
     Care Act is amended by striking subparagraph (D) and 
     inserting the following:
       ``(D) Requirement of members of congress to enroll in an 
     exchange.--
       ``(i) Requirement.--Notwithstanding any other provision of 
     law, all Members of Congress shall be enrolled in an Exchange 
     when established under section 1321.
       ``(ii) Ineligible for fehbp.--Effective on the date on 
     which an Exchange is established under section 1321, 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 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 an Exchange. 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) Exchange.--The term `Exchange' means an Exchange 
     established under section 1321.
       ``(II) Member of congress.--The term `Member of Congress' 
     means any member of the House of Representatives or the 
     Senate.''.

                                 ______
                                 
  SA 3668. Mr. VITTER submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, add the following:

     SEC. 15__. REFUNDS OF FEDERAL MOTOR FUEL EXCISE TAXES FOR 
                   FUEL USED IN MOBILE MAMMOGRAPHY VEHICLES.

       (a) Refunds.--Section 6427 of the Internal Revenue Code of 
     1986 (relating to fuels not used for taxable purposes) is 
     amended by inserting after subsection (f) the following new 
     subsection:
       ``(g) Fuels Used in Mobile Mammography Vehicles.--Except as 
     provided in subsection (k), if any fuel on which tax was 
     imposed by section 4041 or 4081 is used in any highway 
     vehicle designed exclusively to provide mobile mammography 
     services to patients within such vehicle, the Secretary shall 
     pay (without interest) to the ultimate purchaser of such fuel 
     an amount equal to the aggregate amount of the tax imposed on 
     such fuel.''.
       (b) Exemption From Retail Tax.--Section 4041 of such Code 
     is amended by adding at the end the following new subsection:
       ``(n) Fuels Used in Mobile Mammography Vehicles.--No tax 
     shall be imposed under this section on any liquid sold for 
     use in, or used in, any highway vehicle designed exclusively 
     to provide mobile mammography services to patients within 
     such vehicle.''.
       (c) Effective Date.--The amendments made by this section 
     shall take effect on the date of the enactment of this Act.
                                 ______
                                 
  SA 3669. Mr. VITTER submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end, add the following:

              TITLE III--IMPORTATION OF PRESCRIPTION DRUGS

     SEC. 3001. SHORT TITLE.

       This title may be cited as the ``Pharmaceutical Market 
     Access Act of 2010''.

     SEC. 3002. FINDINGS.

       Congress finds as follows:
       (1) Americans unjustly pay up to 1,000 percent more to fill 
     their prescriptions than consumers in other countries.
       (2) The United States is the world's largest market for 
     pharmaceuticals yet consumers still pay the world's highest 
     prices.
       (3) An unaffordable drug is neither safe nor effective. 
     Allowing and structuring the importation of prescription 
     drugs ensures access to affordable drugs, thus providing a 
     level of safety to American consumers they do not currently 
     enjoy.
       (4) Prescription drugs are a leading cost of the growth in 
     health care spending in the United States, which is projected 
     to reach $2,600,000,000,000 in 2009, according to the 
     Congressional Budget Office.
       (5) According to the Congressional Budget Office, American 
     seniors alone will spend $1,800,000,000,000 on 
     pharmaceuticals over the next 10 years.
       (6) Allowing open pharmaceutical markets could save 
     American consumers at least $635,000,000,000 of their own 
     money.

     SEC. 3003. 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. 3004. 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--
       ``(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

[[Page 4914]]

     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 2010, 
     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 2010, 
     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;
       ``(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. 3005. 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.

[[Page 4915]]

       ``(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 2010 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 2010, 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. 3006. 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 2010.''.

     SEC. 3007. 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. 3008. 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. 3009. OTHER ENFORCEMENT ACTIONS.

       (a) In General.--Section 804 of the Federal Food, Drug, and 
     Cosmetic Act, as amended by section 3004, is amended by 
     adding at the end the following:
       ``(l) Unfair or Discriminatory Acts and Practices.--
       ``(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;

[[Page 4916]]

       ``(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.

       ``(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 2010 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,

[[Page 4917]]

     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 3004(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. 3010. 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 3670. Mr. ENZI submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 143, between lines 17 and 18, insert the following:

     SEC. 2213. DIRECT LENDING ADMINISTRATIVE EXPENSES.

       Section 458(a) (20 U.S.C. 1087h(a)) (as amended by section 
     2212(b)(1)) is amended--
       (1) by striking paragraph (3) and inserting the following:
       ``(2) Mandatory funds for administrative costs in fiscal 
     years 2010 through 2019.--For each of the fiscal years 2010 
     through 2019, there shall be available to the Secretary, from 
     funds not otherwise appropriated, such sums as may be 
     necessary for the administrative costs under this part and 
     part B, including the costs of the direct student loan 
     programs under this part, in each such fiscal year.'';
       (2) in paragraph (4), by striking ``through 2014'' and 
     inserting ``through 2019''.
                                 ______
                                 
  SA 3671. Mr. ENZI (for himself and Mr. Coburn) submitted an amendment 
intended to be proposed by him to the bill H.R. 4872, to provide for 
reconciliation pursuant to Title II of the concurrent resolution on the 
budget for fiscal year 2010 (S. Con. Res. 13); which was ordered to lie 
on the table; as follows:

       On page 114, between lines 12 and 13, insert the following:

     SEC. 2002. ELIMINATION OF SPENDING IN ORDER TO REDUCE THE 
                   PUBLIC DEBT.

       Notwithstanding any other provision of this title, sections 
     2101, 2102, 2103, and 2213, and the amendments made by such 
     sections, shall have no force and effect, and the resulting 
     savings shall be used to reduce the public debt.
                                 ______
                                 
  SA 3672. Mr. ENZI submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       Beginning on page 114, strike line 13 and all that follows 
     through line 8 on page 123 and insert the following:

                      PART I--EXTENSION OF ECASLA

     SEC. 2101. EXTENSION OF STUDENT LOAN PURCHASE AUTHORITY.

       Section 459A (20 U.S.C. 1087i-1) is amended--
       (1) in subsections (a)(1), (a)(3)(A), and (f), by striking 
     ``July 1, 2010'' and inserting ``July 1, 2011''; and
       (2) in subsection (e)--
       (A) in the matter preceding clause (i) of paragraph (1)(A) 
     and the matter preceding subparagraph (A) of paragraph (2), 
     by striking ``September 30, 2010'' and inserting ``September 
     30, 2011'';
       (B) in paragraph (2), by striking ``February 15, 2011'' and 
     inserting ``February 15, 2012''; and
       (C) in paragraph (3), by striking ``2010, and 2011'' and 
     inserting ``2010, 2011, and 2012''.

     SEC. 2102. EXTENSION OF AUTHORITY TO DESIGNATE LENDERS FOR 
                   LENDER-OF-LAST-RESORT PROGRAM.

       Section 428(j) (20 U.S.C. 1078(j)) is amended--
       (1) in paragraph (6), by striking ``June 30, 2010'' and 
     inserting ``June 30, 2011'';
       (2) in paragraph (7), by striking ``June 30, 2010'' and 
     inserting ``June 30, 2011''; and
       (3) in paragraph (9)(A)--
       (A) in the matter preceding subclause (I) of clause (ii), 
     by striking ``June 30, 2011'' and inserting ``June 30, 
     2012'';
       (B) in subclause (III) of clause (ii), by striking ``June 
     30, 2010'' and inserting ``June 30, 2011''; and
       (C) in the matter preceding subclause (I) of clause (iii), 
     by striking ``July 1, 2011'' and inserting ``July 1, 2012''.

     SEC. 2103. ONE-YEAR DELAY OF FFEL TERMINATION.

       (a) One-Year Delay.--Title IV (as amended by part II) (20 
     U.S.C. 1070 et seq.) is further amended--
       (1) in section 427A(l)(4), by inserting the following:
       ``(D) For a loan for which the first disbursement is made 
     on or after July 1, 2010, and before July 1, 2011, 4.5 
     percent on the unpaid principal balance of the loan.'';
       (2) in section 438(c)(2)(B)--
       (A) in clause (iii), by striking ``; and'' and inserting a 
     semicolon;
       (B) in clause (iv), by striking the period and inserting 
     ``; and''; and
       (C) by adding at the end the following:
       ``(v) by substituting `0.0 percent' for `3.0 percent' with 
     respect to loans for which the first disbursement of 
     principal is made on or after July 1, 2010 and before July 1, 
     2011.'';
       (3) in section 456(a)(4)(A)(iii), by striking ``2014'' and 
     inserting ``2015''; and
       (4) in section 458(a)(2), by striking ``2010 through 2019'' 
     and inserting ``2011 through 2019'';
       (5) in sections 458(a)(7)(B) and 459B(a)(3), by striking 
     ``2011'' and inserting ``2012'';
       (6) in the headings of sections 427A(l), 438(b)(2)(I), and 
     438(b)(2)(I)(vi), by striking ``2010'' and inserting 
     ``2011'';
       (7) in sections 421(b), 428B(a)(1), 458(a)(6)(B), and 
     459B(a)(3), subsections (f) and (j)(1) of section 428, 
     subsections (c)(2)(B)(6) and (d)(2)(B) of section 438, and 
     subsections (a)(1) and (g) of section 455, by striking 
     ``2010'' and inserting ``2011'';
       (8) in sections 421(d), 424(a), 427A(l), 428B(a)(1), 428C, 
     428H, 438(b)(2)(I), and 458(a)(7), and subsections (a) and 
     (b)(1) of section 428, by striking ``2010'' each place the 
     term appears and inserting ``2011''; and
       (9) in sections 424(a) and 456(c)(1)(B), by striking 
     ``2009'' each place the term appears and inserting ``2010''.
       (b) Delayed Implementation.--Notwithstanding section 
     2209(b)(2), 2210(b), or 2211(b) or any other provision of 
     this title--
       (1) subsection (a) and part II, and the amendments made by 
     such subsection and part, shall not be effective until the 
     day that is one year after the date of enactment of this Act; 
     and
       (2) sections 2210(b) and 2211(b) shall be applied, 
     beginning on the date described in paragraph (1), by striking 
     ``July 1, 2010'' and inserting ``July 1, 2011''.

     SEC. 2104. ELIMINATION OF INCOME-BASED REPAYMENT CHANGES.

       Notwithstanding any other provision of this title, section 
     2213 and the amendments made by such section shall have no 
     force and effect.
                                 ______
                                 
  SA 3673. Mr. ENZI submitted an amendment intended to be proposed by

[[Page 4918]]

him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of part II of subtitle A of title II, add the 
     following:

     SEC. 2214. GRANT PROHIBITION.

       For fiscal year 2012 and succeeding fiscal years, and 
     notwithstanding any other provision of law, the Secretary of 
     Education, the Secretary of Health and Human Services, and 
     the Secretary of Labor shall not award a grant to an 
     institution of higher education that increases the tuition 
     and fees charged for attendance at the institution at a rate 
     that is greater than the annual increase in the Consumer 
     Price Index prepared by the Department of Labor.
                                 ______
                                 
  SA 3674. Mr. HATCH submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle B of title II, insert the following:

     SEC. 2__. EXEMPTION RELATING TO EXCHANGE REQUIREMENTS.

       Section 1311 of the Patient Protection and Affordable Care 
     Act is amended by adding at the end the following:
       ``(l) Exemption.--The provisions of this section shall not 
     apply to any State that has a State exchange in operation on 
     the date of enactment of this Act. Such exchange shall be 
     deemed to meet all requirements applicable to Exchanges under 
     this section.''.
                                 ______
                                 
  SA 3675. Mr. HATCH submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle A of title I, insert the following:

     SEC. 1__. REPEAL OF INDIVIDUAL MANDATE.

       Section 5000A of the Internal Revenue Code of 1986, as 
     added by section 1501(b) of the Patient Protection and 
     Affordable Care Act, is repealed.
                                 ______
                                 
  SA 3676. Ms. COLLINS submitted an amendment intended to be proposed 
by her to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle E of title I, insert the following:

     SECTION __. HEALTH CARE COST INCREASE TAX CREDIT.

       (a) In General.--Subpart A of part IV of subchapter A of 
     chapter 1 of the Internal Revenue Code of 1986 is amended by 
     inserting after section 25D the following new section:

     ``SEC. 25E. HEALTH CARE COST INCREASE TAX CREDIT.

       ``(a) In General.--In the case of an eligible taxpayer, 
     there shall be allowed a credit against the tax imposed by 
     this chapter for the taxable year in an amount equal to the 
     lesser of--
       ``(1) the health care cost increase amount for such taxable 
     year, or
       ``(2) the eligible taxpayer's premium increase amount for 
     such taxable year.
       ``(b) Eligible Taxpayer.--For purposes of this section, the 
     term `eligible taxpayer' means an individual who purchases 
     self-only or family health insurance coverage which is a 
     qualified health plan within the meaning of section 
     36B(c)(3)(A) for all months in the taxable year.
       ``(c) Health Care Cost Increase Amount.--
       ``(1) In general.--For purposes of this section, with 
     respect to taxable years beginning in any calendar year after 
     2009, the health care cost increase amount is the amount, as 
     determined by the Secretary of Health and Human Services, by 
     which the average national premium cost for a plan in the 
     silver level of coverage (within the meaning of section 
     1302(d)(1)(B) of the Patient Protection and Affordable Care 
     Act) for such calendar year exceeds the average national 
     premium cost for such a plan as of March 23, 2010.
       ``(2) Publication of determination.--The Secretary of 
     Health and Human Services shall publish the health care cost 
     increase amount determined under paragraph (1) for each 
     calendar year not later than December 31 of such calendar 
     year.
       ``(d) Premium Increase Amount.--
       ``(1) In general.--For purposes of this section, with 
     respect to an eligible taxpayer, the premium increase amount 
     is the amount by which the total premiums paid by such 
     taxpayer for months during the taxable year for coverage 
     described in subsection (b) exceed the total premiums paid by 
     such taxpayer for such coverage for the last plan year ending 
     before March 23, 2010, except that such amount--
       ``(A) shall be adjusted to reflect any changes in coverage 
     under the taxpayer's plan or in the family size of the 
     taxpayer, and
       ``(B) shall be reduced by the amount of any credit under 
     section 36B and any Federal cost sharing subsidy with respect 
     to such coverage.
       ``(2) Regulatory authority.--The Secretary of Health and 
     Human Services shall prescribe regulations for determining 
     the adjustments required under paragraph (1)(A).
       ``(e) Credit Allowed Against Alternative Minimum Tax.--In 
     the case of a taxable year to which section 26(a)(2) does not 
     apply, the credit allowed under subsection (a) for any 
     taxable year shall not exceed the excess of--
       ``(1) the sum of the regular tax liability (as defined in 
     section 26(b)) plus the tax imposed by section 55, over
       ``(2) the sum of the credits allowable under this subpart 
     (other than this section and sections 23, 25D, and 30D) and 
     section 27 for the taxable year.''.
       (b) Clerical Amendment.--The table of sections for subpart 
     A of part IV of subchapter A of chapter 1 of the Internal 
     Revenue Code of 1986 is amended by inserting after the item 
     relating to section 25D the following new item:

``Sec. 25E. Health care cost increase credit.''.
       (c) Conforming Amendments.--
       (1) Section 24(b)(3)(B) of the Internal Revenue Code of 
     1986 is amended by inserting ``25E,'' after ``25D,''.
       (2) Section 25(e)(1)(C)(ii) of such Code is amended by 
     inserting ``25E,'' after ``25D,''.
       (3) Section 26(a)(1) of such Code is amended by inserting 
     ``25E,'' after ``25D,''.
       (4) Section 25B(g)(2) of such Code is amended by inserting 
     ``25E,'' after ``25D,''.
       (5) Section 904(i) of such Code is amended by inserting 
     ``25E,'' after ``25B,''.
       (6) Section 1400C(d)(2) of such Code is amended by 
     inserting ``25E,'' after ``25D,''.
       (d) Application of EGGTRA Sunset.--The amendment made by 
     subsection (c)(1) shall be subject to title IX of the 
     Economic Growth and Tax Relief Reconciliation Act of 2001 in 
     the same manner as the provision of such Act to which such 
     amendment relates.
       (e) Effective Date.--The amendments made by subsections 
     (a), (b), and (c) shall apply to taxable years ending after 
     March 23, 2010.
                                 ______
                                 
  SA 3677. Mr. LeMIEUX submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle D of title I, add the following:

     SEC. 1305. HEALTH CARE FRAUD PREVENTION SYSTEM.

       (a) Health Care Fraud Prevention System.--
       (1) In general.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall 
     establish a fraud prevention system which shall be designed 
     as follows:
       (A) In general.--The fraud prevention system shall--
       (i) be holistic;
       (ii) be able to view all provider and patient activities 
     across all Federal health program payers;
       (iii) be able to integrate into the existing health care 
     claims flow with minimal effort, time, and cost;
       (iv) be modeled after systems used in the Financial 
     Services industry; and
       (v) utilize integrated real-time transaction risk scoring 
     and referral strategy capabilities to identify claims that 
     are statistically unusual.
       (B) Modularized architecture.--The fraud prevention system 
     shall be designed from an end-to-end modularized perspective 
     to allow for ease of integration into multiple points along a 
     health care claim flow (pre- or post-adjudication), which 
     shall--
       (i) utilize a single entity to host, support, manage, and 
     maintain software-based services, predictive models, and 
     solutions from a central location for the customers who 
     access the fraud prevention system;
       (ii) allow access through a secure private data connection 
     rather than the installation of software in multiple 
     information technology infrastructures (and data facilities);
       (iii) provide access to the best and latest software 
     without the need for upgrades, data security, and costly 
     installations;
       (iv) permit modifications to the software and system edits 
     in a rapid and timely manner;
       (v) ensure that all technology and decision components 
     reside within the module; and
       (vi) ensure that the third party host of the modular 
     solution is not a party, payer, or stakeholder that reports 
     claims data, accesses the results of the fraud prevention 
     systems analysis, or is otherwise required under this section 
     to verify, research, or investigate the risk of claims.

[[Page 4919]]

       (C) Processing, scoring, and storage.--The platform of the 
     fraud prevention system shall be a high volume, rapid, real-
     time information technology solution, which includes data 
     pooling, data storage, and scoring capabilities to quickly 
     and accurately capture and evaluate data from millions of 
     claims per day. Such platform shall be secure and have (at a 
     minimum) data centers that comply with Federal and State 
     privacy laws.
       (D) Data consortium.--The fraud prevention system shall 
     provide for the establishment of a centralized data file 
     (referred to as a ``consortium'') that accumulates data from 
     all government health insurance claims data sources. 
     Notwithstanding any other provision of law, Federal health 
     care payers shall provide to the consortium existing claims 
     data, such as Medicare's ``Common Working File'' and Medicaid 
     claims data, for the purpose of fraud and abuse prevention. 
     Such accumulated data shall be transmitted and stored in an 
     industry standard secure data environment that complies with 
     applicable Federal privacy laws for use in building medical 
     waste, fraud, and abuse prevention predictive models that 
     have a comprehensive view of provider activity across all 
     payers (and markets).
       (E) Market view.--The fraud prevention system shall ensure 
     that claims data from Federal health programs and all markets 
     flows through a central source so the waste, fraud, and abuse 
     system can look across all markets and geographies in health 
     care to identify fraud and abuse in Medicare, Medicaid, the 
     State Children's Health Program, TRICARE, and the Department 
     of Veterans Affairs, holistically. Such cross-market 
     visibility shall identify unusual provider and patient 
     behavior patterns and fraud and abuse schemes that may not be 
     identified by looking independently at one Federal payer's 
     transactions.
       (F) Behavior engine.--The fraud prevention system shall 
     ensure that the technology used provides real-time ability to 
     identify high-risk behavior patterns across markets, 
     geographies, and specialty group providers to detect waste, 
     fraud, and abuse, and to identify providers that exhibit 
     unusual behavior patterns. Behavior pattern technology that 
     provides the capability to compare a provider's current 
     behavior to their own past behavior and to compare a 
     provider's current behavior to that of other providers in the 
     same specialty group and geographic location shall be used in 
     order to provide a comprehensive waste, fraud, and abuse 
     prevention solution.
       (G) Predictive model.--The fraud prevention system shall 
     involve the implementation of a statistically sound, 
     empirically derived predictive modeling technology that is 
     designed to prevent (versus post-payment detect) waste, 
     fraud, and abuse. Such prevention system shall utilize 
     historical transaction data, from across all Federal health 
     programs and markets, to build and re-develop scoring models, 
     have the capability to incorporate external data and external 
     models from other sources into the health care predictive 
     waste, fraud, and abuse model, and provide for a feedback 
     loop to provide outcome information on verified claims so 
     future system enhancements can be developed based on previous 
     claims experience.
       (H) Change control.--The fraud prevention system platform 
     shall have the infrastructure to implement new models and 
     attributes in a test environment prior to moving into a 
     production environment. Capabilities shall be developed to 
     quickly make changes to models, attributes, or strategies to 
     react to changing patterns in waste, fraud, and abuse.
       (I) Scoring engine.--The fraud prevention system shall 
     identify high-risk claims by scoring all such claims on a 
     real-time capacity prior to payment. Such scores shall then 
     be communicated to the fraud management system provided for 
     under subparagraph (J).
       (J) Fraud management system.--The fraud prevention system 
     shall utilize a fraud management system, that contains 
     workflow management and workstation tools to provide the 
     ability to systematically present scores, reason codes, and 
     treatment actions for high-risk scored transactions. The 
     fraud prevention system shall ensure that analysts who review 
     claims have the capability to access, review, and research 
     claims efficiently, as well as decline or approve claims 
     (payments) in an automated manner. Workflow management under 
     this subparagraph shall be combined with the ability to 
     utilize principles of experimental design to compare and 
     measure prevention and detection rates between test and 
     control strategies. Such strategy testing shall allow for 
     continuous improvement and maximum effectiveness in keeping 
     up with ever changing fraud and abuse patterns. Such system 
     shall provide the capability to test different treatments or 
     actions randomly (typically through use of random digit 
     assignments).
       (K) Decision technology.--The fraud prevention system shall 
     have the capability to monitor consumer transactions in real-
     time and monitor provider behavior at different stages within 
     the transaction flow based upon provider, transaction and 
     consumer trends. The fraud prevention system shall provide 
     for the identification of provider and claims excessive usage 
     patterns and trends that differ from similar peer groups, 
     have the capability to trigger on multiple criteria, such as 
     predictive model scores or custom attributes, and be able to 
     segment transaction waste, fraud, and abuse into multiple 
     types for health care categories and business types.
       (L) Feedback loop.--The fraud prevention system shall have 
     a feedback loop where all Federal health payers provide pre-
     payment and post-payment information about the eventual 
     status of a claim designated as ``Normal'', ``Waste'', 
     ``Fraud'', ``Abuse'', or ``Education Required''. Such 
     feedback loop shall enable Federal health agencies to measure 
     the actual amount of waste, fraud, and abuse as well as the 
     savings in the system and provide the ability to retrain 
     future, enhanced models. Such feedback loop shall be an 
     industry file that contains information on previous fraud and 
     abuse claims as well as abuse perpetrated by consumers, 
     providers, and fraud rings, to be used to alert other payers, 
     as well as for subsequent fraud and abuse solution 
     development.
       (M) Tracking and reporting.--The fraud prevention system 
     shall ensure that the infrastructure exists to ascertain 
     system, strategy, and predictive model return on investment. 
     Dynamic model validation and strategy validation analysis and 
     reporting shall be made available to ensure a strategy or 
     predictive model has not degraded over time or is no longer 
     effective. Queue reporting shall be established and made 
     available for population estimates of what claims were 
     flagged, what claims received treatment, and ultimately what 
     results occurred. The capability shall exist to complete 
     tracking and reporting for prevention strategies and actions 
     residing farther upstream in the health care payment flow. 
     The fraud prevention system shall establish a reliable metric 
     to measure the dollars that are never paid due to 
     identification of fraud and abuse, as well as a capability to 
     effectively test and estimate the impact from different 
     actions and treatments utilized to detect and prevent fraud 
     and abuse for legitimate claims. Measuring results shall 
     include waste and abuse.
       (N) Operating tenet.--The fraud prevention system shall not 
     be designed to deny health care services or to negatively 
     impact prompt-pay laws because assessments are late. The 
     database shall be designed to speed up the payment process. 
     The fraud prevention system shall require the implementation 
     of constant and consistent test and control strategies by 
     stakeholders, with results shared with Federal health program 
     leadership on a quarterly basis to validate improving 
     progress in identifying and preventing waste, fraud, and 
     abuse. Under such implementation, Federal health care payers 
     shall use standard industry waste, fraud, and abuse measures 
     of success.
       (2) Coordination.--The Secretary shall coordinate the 
     operation of the fraud prevention system with the Department 
     of Justice and other related Federal fraud prevention 
     systems.
       (3) Operation.--The Secretary shall phase-in the 
     implementation of the system under this subsection beginning 
     not later than 18 months after the date of enactment of this 
     Act, through the analysis of a limited number of Federal 
     health program claims. Not later than 5 years after such date 
     of enactment, the Secretary shall ensure that such system is 
     fully phased-in and applicable to all Federal health program 
     claims.
       (4) Non-payment of claims.--The Secretary shall promulgate 
     regulations to prohibit the payment of any health care claim 
     that has been identified as potentially ``fraudulent'', 
     ``wasteful'', or ``abusive'' until such time as the claim has 
     been verified as valid.
       (5) Application.--The system under this section shall only 
     apply to Federal health programs (all such programs), 
     including programs established after the date of enactment of 
     this Act.
       (6) Regulations.--The Secretary shall promulgate 
     regulations providing the maximum appropriate protection of 
     personal privacy.
       (b) Protecting Participation in Health Care Antifraud 
     Programs.--
       (1) In general.--Notwithstanding any other provision of 
     law, no person providing information to the Secretary under 
     this section shall be held, by reason of having provided such 
     information, to have violated any criminal law, or to be 
     civilly liable under any law of the United States or of any 
     State (or political subdivision thereof) unless such 
     information is false and the person providing it knew, or had 
     reason to believe, that such information was false.
       (2) Confidentiality.--The Secretary shall, through the 
     promulgation of regulations, establish standards for--
       (A) the protection of confidential information submitted or 
     obtained with regard to suspected or actual health care 
     fraud;
       (B) the protection of the ability of representatives the 
     Department of Health and Human Services to testify in private 
     civil actions concerning any such information; and
       (C) the sharing by the Department of Health and Human 
     Services of any such information related to the medical 
     antifraud programs established under this section.
       (c) Use of Savings.--Notwithstanding any other provision of 
     law, amounts remaining at the end of a fiscal year in the 
     account for

[[Page 4920]]

     any Federal health program to which this section applies that 
     the Secretary of Health and Human Services determines are 
     remaining as a result of the fraud prevention activities 
     applied under this section shall remain in such account and 
     be used for such program for the next fiscal year.
       (d) Definition.--In this section, the term ``Federal health 
     program'' means any program that provides Federal payments or 
     reimbursements to providers of health-related items or 
     services, or suppliers of such items, for the provision of 
     such items or services to an individual patient.
       (e) Recission of Certain Stimulus Funds.--Notwithstanding 
     section 5 of the American Recovery and Reinvestment Act of 
     2009 (Public Law 111-5; 123 Stat. 116), from the amounts 
     appropriated or made available under division A of such Act 
     (other than under title X of such division A), there is 
     rescinded, of the remaining unobligated amounts as of the 
     date of the enactment of this Act, funds in the amount as may 
     be necessary to carry out this section. The Director of the 
     Office of Management and Budget shall report to each 
     congressional committee the amounts so rescinded within the 
     jurisdiction of such committee.
                                 ______
                                 
  SA 3678. Mr. LeMIEUX submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, add the following:

     SEC. 1__. PRODUCTIVITY AWARD PROGRAM.

       Not later than 1 year after the date of enactment of this 
     Act, the Secretary of Health and Human Services shall 
     establish a Productivity Award Program to recognize 
     employees, work units, and contractors of the Centers for 
     Medicare & Medicaid whose work significantly and measurably 
     increases productivity and promotes innovation to improve the 
     delivery of services and achieving savings for taxpayers. The 
     amount of any such award shall be equal to 10 percent of the 
     amount of the estimated saving to the Federal Government as a 
     result of the action resulting in the award (as determined by 
     the Secretary), but not to exceed $50,000.
                                 ______
                                 
  SA 3679. Mr. LeMIEUX submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, add the following:

     SEC. 1__. CONSUMER RIGHT-TO-KNOW.

       (a) Development of Information System.--Not later than 1 
     year after the date of enactment of this Act, the Secretary 
     of Health and Human Services (referred to in this section as 
     the ``Secretary'') shall develop a system for the collection 
     of quality and pricing information related to the provision 
     of health care services. Through the use of such information, 
     the Secretary shall, to the extent practicable--
       (1) determine the lowest, median, average, and highest 
     charged amount and reimbursed amount for each outpatient and 
     inpatient health care procedure conducted at each facility in 
     the United States;
       (2) provide comparisons of such prices with respect to 
     procedures in similar facilities in the same county, city, 
     State and on a national basis; and
       (3) develop quality of care data, including data on 
     consumer satisfaction, coordination and continuity of care, 
     infrastructure, the results of accreditation, Medicare-
     related information, and other survey information, and 
     combine such data with price information to enable consumers 
     to make informed choices.
       (b) Use of Existing Sources.--To the extent that the 
     information required under subsection (a) is being collected 
     by the Centers for Medicare & Medicaid Services, States, 
     State medical societies, or private sector entities, the 
     Secretary, to the extent practicable, utilize such 
     information to carry out such subsection.
       (c) Availability of Information.--The Secretary, either 
     directly or through contract, shall make the information and 
     data collected and developed under this section available on 
     an Internet website. Such information and data shall be 
     displayed by payer (such as Medicare, Medicaid, health 
     insurance plans, employer-based health plans, and other types 
     of health care coverage).
                                 ______
                                 
  SA 3680. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

                 TITLE _MEDICAL CARE ACCESS PROTECTION

     SEC. _1. SHORT TITLE.

       This title may be cited as the ``Medical Care Access 
     Protection Act of 2009'' or the ``MCAP Act''.

     SEC. _2. DEFINITIONS.

       In this title:
       (1) Alternative dispute resolution system; adr.--The term 
     ``alternative dispute resolution system'' or ``ADR'' means a 
     system that provides for the resolution of health care 
     lawsuits in a manner other than through a civil action 
     brought in a State or Federal court.
       (2) Claimant.--The term ``claimant'' means any person who 
     brings a health care lawsuit, including a person who asserts 
     or claims a right to legal or equitable contribution, 
     indemnity or subrogation, arising out of a health care 
     liability claim or action, and any person on whose behalf 
     such a claim is asserted or such an action is brought, 
     whether deceased, incompetent, or a minor.
       (3) Collateral source benefits.--The term ``collateral 
     source benefits'' means any amount paid or reasonably likely 
     to be paid in the future to or on behalf of the claimant, or 
     any service, product or other benefit provided or reasonably 
     likely to be provided in the future to or on behalf of the 
     claimant, as a result of the injury or wrongful death, 
     pursuant to--
       (A) any State or Federal health, sickness, income-
     disability, accident, or workers' compensation law;
       (B) any health, sickness, income-disability, or accident 
     insurance that provides health benefits or income-disability 
     coverage;
       (C) any contract or agreement of any group, organization, 
     partnership, or corporation to provide, pay for, or reimburse 
     the cost of medical, hospital, dental, or income disability 
     benefits; and
       (D) any other publicly or privately funded program.
       (4) Compensatory damages.--The term ``compensatory 
     damages'' means objectively verifiable monetary losses 
     incurred as a result of the provision of, use of, or payment 
     for (or failure to provide, use, or pay for) health care 
     services or medical products, such as past and future medical 
     expenses, loss of past and future earnings, cost of obtaining 
     domestic services, loss of employment, and loss of business 
     or employment opportunities, damages for physical and 
     emotional pain, suffering, inconvenience, physical 
     impairment, mental anguish, disfigurement, loss of enjoyment 
     of life, loss of society and companionship, loss of 
     consortium (other than loss of domestic service), hedonic 
     damages, injury to reputation, and all other nonpecuniary 
     losses of any kind or nature. Such term includes economic 
     damages and noneconomic damages, as such terms are defined in 
     this section.
       (5) Contingent fee.--The term ``contingent fee'' includes 
     all compensation to any person or persons which is payable 
     only if a recovery is effected on behalf of one or more 
     claimants.
       (6) Economic damages.--The term ``economic damages'' means 
     objectively verifiable monetary losses incurred as a result 
     of the provision of, use of, or payment for (or failure to 
     provide, use, or pay for) health care services or medical 
     products, such as past and future medical expenses, loss of 
     past and future earnings, cost of obtaining domestic 
     services, loss of employment, and loss of business or 
     employment opportunities.
       (7) Health care goods or services.--The term ``health care 
     goods or services'' means any goods or services provided by a 
     health care institution, provider, or by any individual 
     working under the supervision of a health care provider, that 
     relates to the diagnosis, prevention, care, or treatment of 
     any human disease or impairment, or the assessment of the 
     health of human beings.
       (8) Health care institution.--The term ``health care 
     institution'' means any entity licensed under Federal or 
     State law to provide health care services (including but not 
     limited to ambulatory surgical centers, assisted living 
     facilities, emergency medical services providers, hospices, 
     hospitals and hospital systems, nursing homes, or other 
     entities licensed to provide such services).
       (9) Health care lawsuit.--The term ``health care lawsuit'' 
     means any health care liability claim concerning the 
     provision of health care goods or services affecting 
     interstate commerce, or any health care liability action 
     concerning the provision of (or the failure to provide) 
     health care goods or services affecting interstate commerce, 
     brought in a State or Federal court or pursuant to an 
     alternative dispute resolution system, against a health care 
     provider or a health care institution regardless of the 
     theory of liability on which the claim is based, or the 
     number of claimants, plaintiffs, defendants, or other 
     parties, or the number of claims or causes of action, in 
     which the claimant alleges a health care liability claim.
       (10) Health care liability action.--The term ``health care 
     liability action'' means a civil action brought in a State or 
     Federal Court or pursuant to an alternative dispute 
     resolution system, against a health care provider or a health 
     care institution regardless of the theory of liability on 
     which the claim is based, or the number of plaintiffs, 
     defendants, or other parties, or the number of

[[Page 4921]]

     causes of action, in which the claimant alleges a health care 
     liability claim.
       (11) Health care liability claim.--The term ``health care 
     liability claim'' means a demand by any person, whether or 
     not pursuant to ADR, against a health care provider or health 
     care institution, including third-party claims, cross-claims, 
     counter-claims, or contribution claims, which are based upon 
     the provision of, use of, or payment for (or the failure to 
     provide, use, or pay for) health care services, regardless of 
     the theory of liability on which the claim is based, or the 
     number of plaintiffs, defendants, or other parties, or the 
     number of causes of action.
       (12) Health care provider.--
       (A) In general.--The term ``health care provider'' means 
     any person (including but not limited to a physician (as 
     defined by section 1861(r) of the Social Security Act (42 
     U.S.C. 1395x(r)), registered nurse, dentist, podiatrist, 
     pharmacist, chiropractor, or optometrist) required by State 
     or Federal law to be licensed, registered, or certified to 
     provide health care services, and being either so licensed, 
     registered, or certified, or exempted from such requirement 
     by other statute or regulation.
       (B) Treatment of certain professional associations.--For 
     purposes of this title, a professional association that is 
     organized under State law by an individual physician or group 
     of physicians, a partnership or limited liability partnership 
     formed by a group of physicians, a nonprofit health 
     corporation certified under State law, or a company formed by 
     a group of physicians under State law shall be treated as a 
     health care provider under subparagraph (A).
       (13) Malicious intent to injure.--The term ``malicious 
     intent to injure'' means intentionally causing or attempting 
     to cause physical injury other than providing health care 
     goods or services.
       (14) Noneconomic damages.--The term ``noneconomic damages'' 
     means damages for physical and emotional pain, suffering, 
     inconvenience, physical impairment, mental anguish, 
     disfigurement, loss of enjoyment of life, loss of society and 
     companionship, loss of consortium (other than loss of 
     domestic service), hedonic damages, injury to reputation, and 
     all other nonpecuniary losses of any kind or nature.
       (15) Punitive damages.--The term ``punitive damages'' means 
     damages awarded, for the purpose of punishment or deterrence, 
     and not solely for compensatory purposes, against a health 
     care provider or health care institution. Punitive damages 
     are neither economic nor noneconomic damages.
       (16) Recovery.--The term ``recovery'' means the net sum 
     recovered after deducting any disbursements or costs incurred 
     in connection with prosecution or settlement of the claim, 
     including all costs paid or advanced by any person. Costs of 
     health care incurred by the plaintiff and the attorneys' 
     office overhead costs or charges for legal services are not 
     deductible disbursements or costs for such purpose.
       (17) State.--The term ``State'' means each of the several 
     States, the District of Columbia, the Commonwealth of Puerto 
     Rico, the Virgin Islands, Guam, American Samoa, the Northern 
     Mariana Islands, the Trust Territory of the Pacific Islands, 
     and any other territory or possession of the United States, 
     or any political subdivision thereof.

     SEC. _3. ENCOURAGING SPEEDY RESOLUTION OF CLAIMS.

       (a) In General.--Except as otherwise provided for in this 
     section, the time for the commencement of a health care 
     lawsuit shall be 3 years after the date of manifestation of 
     injury or 1 year after the claimant discovers, or through the 
     use of reasonable diligence should have discovered, the 
     injury, whichever occurs first.
       (b) General Exception.--The time for the commencement of a 
     health care lawsuit shall not exceed 3 years after the date 
     of manifestation of injury unless the tolling of time was 
     delayed as a result of--
       (1) fraud;
       (2) intentional concealment; or
       (3) the presence of a foreign body, which has no 
     therapeutic or diagnostic purpose or effect, in the person of 
     the injured person.
       (c) Minors.--An action by a minor shall be commenced within 
     3 years from the date of the alleged manifestation of injury 
     except that if such minor is under the full age of 6 years, 
     such action shall be commenced within 3 years of the 
     manifestation of injury, or prior to the eighth birthday of 
     the minor, whichever provides a longer period. Such time 
     limitation shall be tolled for minors for any period during 
     which a parent or guardian and a health care provider or 
     health care institution have committed fraud or collusion in 
     the failure to bring an action on behalf of the injured 
     minor.
       (d) Rule 11 Sanctions.--Whenever a Federal or State court 
     determines (whether by motion of the parties or whether on 
     the motion of the court) that there has been a violation of 
     Rule 11 of the Federal Rules of Civil Procedure (or a similar 
     violation of applicable State court rules) in a health care 
     liability action to which this title applies, the court shall 
     impose upon the attorneys, law firms, or pro se litigants 
     that have violated Rule 11 or are responsible for the 
     violation, an appropriate sanction, which shall include an 
     order to pay the other party or parties for the reasonable 
     expenses incurred as a direct result of the filing of the 
     pleading, motion, or other paper that is the subject of the 
     violation, including a reasonable attorneys' fee. Such 
     sanction shall be sufficient to deter repetition of such 
     conduct or comparable conduct by others similarly situated, 
     and to compensate the party or parties injured by such 
     conduct.

     SEC. _4. COMPENSATING PATIENT INJURY.

       (a) Unlimited Amount of Damages for Actual Economic Losses 
     in Health Care Lawsuits.--In any health care lawsuit, nothing 
     in this title shall limit the recovery by a claimant of the 
     full amount of the available economic damages, 
     notwithstanding the limitation contained in subsection (b).
       (b) Additional Noneconomic Damages.--
       (1) Health care providers.--In any health care lawsuit 
     where final judgment is rendered against a health care 
     provider, the amount of noneconomic damages recovered from 
     the provider, if otherwise available under applicable Federal 
     or State law, may be as much as $250,000, regardless of the 
     number of parties other than a health care institution 
     against whom the action is brought or the number of separate 
     claims or actions brought with respect to the same 
     occurrence.
       (2) Health care institutions.--
       (A) Single institution.--In any health care lawsuit where 
     final judgment is rendered against a single health care 
     institution, the amount of noneconomic damages recovered from 
     the institution, if otherwise available under applicable 
     Federal or State law, may be as much as $250,000, regardless 
     of the number of parties against whom the action is brought 
     or the number of separate claims or actions brought with 
     respect to the same occurrence.
       (B) Multiple institutions.--In any health care lawsuit 
     where final judgment is rendered against more than one health 
     care institution, the amount of noneconomic damages recovered 
     from each institution, if otherwise available under 
     applicable Federal or State law, may be as much as $250,000, 
     regardless of the number of parties against whom the action 
     is brought or the number of separate claims or actions 
     brought with respect to the same occurrence, except that the 
     total amount recovered from all such institutions in such 
     lawsuit shall not exceed $500,000.
       (c) No Discount of Award for Noneconomic Damages.--In any 
     health care lawsuit--
       (1) an award for future noneconomic damages shall not be 
     discounted to present value;
       (2) the jury shall not be informed about the maximum award 
     for noneconomic damages under subsection (b);
       (3) an award for noneconomic damages in excess of the 
     limitations provided for in subsection (b) shall be reduced 
     either before the entry of judgment, or by amendment of the 
     judgment after entry of judgment, and such reduction shall be 
     made before accounting for any other reduction in damages 
     required by law; and
       (4) if separate awards are rendered for past and future 
     noneconomic damages and the combined awards exceed the 
     limitations described in subsection (b), the future 
     noneconomic damages shall be reduced first.
       (d) Fair Share Rule.--In any health care lawsuit, each 
     party shall be liable for that party's several share of any 
     damages only and not for the share of any other person. Each 
     party shall be liable only for the amount of damages 
     allocated to such party in direct proportion to such party's 
     percentage of responsibility. A separate judgment shall be 
     rendered against each such party for the amount allocated to 
     such party. For purposes of this section, the trier of fact 
     shall determine the proportion of responsibility of each 
     party for the claimant's harm.

     SEC. _5. MAXIMIZING PATIENT RECOVERY.

       (a) Court Supervision of Share of Damages Actually Paid to 
     Claimants.--
       (1) In general.--In any health care lawsuit, the court 
     shall supervise the arrangements for payment of damages to 
     protect against conflicts of interest that may have the 
     effect of reducing the amount of damages awarded that are 
     actually paid to claimants.
       (2) Contingency fees.--
       (A) In general.--In any health care lawsuit in which the 
     attorney for a party claims a financial stake in the outcome 
     by virtue of a contingent fee, the court shall have the power 
     to restrict the payment of a claimant's damage recovery to 
     such attorney, and to redirect such damages to the claimant 
     based upon the interests of justice and principles of equity.
       (B) Limitation.--The total of all contingent fees for 
     representing all claimants in a health care lawsuit shall not 
     exceed the following limits:
       (i) 40 percent of the first $50,000 recovered by the 
     claimant(s).
       (ii) 33\1/3\ percent of the next $50,000 recovered by the 
     claimant(s).
       (iii) 25 percent of the next $500,000 recovered by the 
     claimant(s).
       (iv) 15 percent of any amount by which the recovery by the 
     claimant(s) is in excess of $600,000.
       (b) Applicability.--
       (1) In general.--The limitations in subsection (a) shall 
     apply whether the recovery is by judgment, settlement, 
     mediation, arbitration, or any other form of alternative 
     dispute resolution.

[[Page 4922]]

       (2) Minors.--In a health care lawsuit involving a minor or 
     incompetent person, a court retains the authority to 
     authorize or approve a fee that is less than the maximum 
     permitted under this section.
       (c) Expert Witnesses.--
       (1) Requirement.--No individual shall be qualified to 
     testify as an expert witness concerning issues of negligence 
     in any health care lawsuit against a defendant unless such 
     individual--
       (A) except as required under paragraph (2), is a health 
     care professional who--
       (i) is appropriately credentialed or licensed in 1 or more 
     States to deliver health care services; and
       (ii) typically treats the diagnosis or condition or 
     provides the type of treatment under review; and
       (B) can demonstrate by competent evidence that, as a result 
     of training, education, knowledge, and experience in the 
     evaluation, diagnosis, and treatment of the disease or injury 
     which is the subject matter of the lawsuit against the 
     defendant, the individual was substantially familiar with 
     applicable standards of care and practice as they relate to 
     the act or omission which is the subject of the lawsuit on 
     the date of the incident.
       (2) Physician review.--In a health care lawsuit, if the 
     claim of the plaintiff involved treatment that is recommended 
     or provided by a physician (allopathic or osteopathic), an 
     individual shall not be qualified to be an expert witness 
     under this subsection with respect to issues of negligence 
     concerning such treatment unless such individual is a 
     physician.
       (3) Specialties and subspecialties.--With respect to a 
     lawsuit described in paragraph (1), a court shall not permit 
     an expert in one medical specialty or subspecialty to testify 
     against a defendant in another medical specialty or 
     subspecialty unless, in addition to a showing of substantial 
     familiarity in accordance with paragraph (1)(B), there is a 
     showing that the standards of care and practice in the two 
     specialty or subspecialty fields are similar.
       (4) Limitation.--The limitations in this subsection shall 
     not apply to expert witnesses testifying as to the degree or 
     permanency of medical or physical impairment.

     SEC. _6. ADDITIONAL HEALTH BENEFITS.

       (a) In General.--The amount of any damages received by a 
     claimant in any health care lawsuit shall be reduced by the 
     court by the amount of any collateral source benefits to 
     which the claimant is entitled, less any insurance premiums 
     or other payments made by the claimant (or by the spouse, 
     parent, child, or legal guardian of the claimant) to obtain 
     or secure such benefits.
       (b) Preservation of Current Law.--Where a payor of 
     collateral source benefits has a right of recovery by 
     reimbursement or subrogation and such right is permitted 
     under Federal or State law, subsection (a) shall not apply.
       (c) Application of Provision.--This section shall apply to 
     any health care lawsuit that is settled or resolved by a fact 
     finder.

     SEC. _7. PUNITIVE DAMAGES.

       (a) Punitive Damages Permitted.--
       (1) In general.--Punitive damages may, if otherwise 
     available under applicable State or Federal law, be awarded 
     against any person in a health care lawsuit only if it is 
     proven by clear and convincing evidence that such person 
     acted with malicious intent to injure the claimant, or that 
     such person deliberately failed to avoid unnecessary injury 
     that such person knew the claimant was substantially certain 
     to suffer.
       (2) Filing of lawsuit.--No demand for punitive damages 
     shall be included in a health care lawsuit as initially 
     filed. A court may allow a claimant to file an amended 
     pleading for punitive damages only upon a motion by the 
     claimant and after a finding by the court, upon review of 
     supporting and opposing affidavits or after a hearing, after 
     weighing the evidence, that the claimant has established by a 
     substantial probability that the claimant will prevail on the 
     claim for punitive damages.
       (3) Separate proceeding.--At the request of any party in a 
     health care lawsuit, the trier of fact shall consider in a 
     separate proceeding--
       (A) whether punitive damages are to be awarded and the 
     amount of such award; and
       (B) the amount of punitive damages following a 
     determination of punitive liability.
     If a separate proceeding is requested, evidence relevant only 
     to the claim for punitive damages, as determined by 
     applicable State law, shall be inadmissible in any proceeding 
     to determine whether compensatory damages are to be awarded.
       (4) Limitation where no compensatory damages are awarded.--
     In any health care lawsuit where no judgment for compensatory 
     damages is rendered against a person, no punitive damages may 
     be awarded with respect to the claim in such lawsuit against 
     such person.
       (b) Determining Amount of Punitive Damages.--
       (1) Factors considered.--In determining the amount of 
     punitive damages under this section, the trier of fact shall 
     consider only the following:
       (A) the severity of the harm caused by the conduct of such 
     party;
       (B) the duration of the conduct or any concealment of it by 
     such party;
       (C) the profitability of the conduct to such party;
       (D) the number of products sold or medical procedures 
     rendered for compensation, as the case may be, by such party, 
     of the kind causing the harm complained of by the claimant;
       (E) any criminal penalties imposed on such party, as a 
     result of the conduct complained of by the claimant; and
       (F) the amount of any civil fines assessed against such 
     party as a result of the conduct complained of by the 
     claimant.
       (2) Maximum award.--The amount of punitive damages awarded 
     in a health care lawsuit may not exceed an amount equal to 
     two times the amount of economic damages awarded in the 
     lawsuit or $250,000, whichever is greater. The jury shall not 
     be informed of the limitation under the preceding sentence.
       (c) Liability of Health Care Providers.--
       (1) In general.--A health care provider who prescribes, or 
     who dispenses pursuant to a prescription, a drug, biological 
     product, or medical device approved by the Food and Drug 
     Administration, for an approved indication of the drug, 
     biological product, or medical device, shall not be named as 
     a party to a product liability lawsuit invoking such drug, 
     biological product, or medical device and shall not be liable 
     to a claimant in a class action lawsuit against the 
     manufacturer, distributor, or product seller of such drug, 
     biological product, or medical device.
       (2) Medical product.--The term ``medical product'' means a 
     drug or device intended for humans. The terms ``drug'' and 
     ``device'' have the meanings given such terms in sections 
     201(g)(1) and 201(h) of the Federal Food, Drug and Cosmetic 
     Act (21 U.S.C. 321), respectively, including any component or 
     raw material used therein, but excluding health care 
     services.

     SEC. _8. AUTHORIZATION OF PAYMENT OF FUTURE DAMAGES TO 
                   CLAIMANTS IN HEALTH CARE LAWSUITS.

       (a) In General.--In any health care lawsuit, if an award of 
     future damages, without reduction to present value, equaling 
     or exceeding $50,000 is made against a party with sufficient 
     insurance or other assets to fund a periodic payment of such 
     a judgment, the court shall, at the request of any party, 
     enter a judgment ordering that the future damages be paid by 
     periodic payments in accordance with the Uniform Periodic 
     Payment of Judgments Act promulgated by the National 
     Conference of Commissioners on Uniform State Laws.
       (b) Applicability.--This section applies to all actions 
     which have not been first set for trial or retrial before the 
     effective date of this title.

     SEC. _9. EFFECT ON OTHER LAWS.

       (a) General Vaccine Injury.--
       (1) In general.--To the extent that title XXI of the Public 
     Health Service Act establishes a Federal rule of law 
     applicable to a civil action brought for a vaccine-related 
     injury or death--
       (A) this title shall not affect the application of the rule 
     of law to such an action; and
       (B) any rule of law prescribed by this title in conflict 
     with a rule of law of such title XXI shall not apply to such 
     action.
       (2) Exception.--If there is an aspect of a civil action 
     brought for a vaccine-related injury or death to which a 
     Federal rule of law under title XXI of the Public Health 
     Service Act does not apply, then this title or otherwise 
     applicable law (as determined under this title) will apply to 
     such aspect of such action.
       (b) Smallpox Vaccine Injury.--
       (1) In general.--To the extent that part C of title II of 
     the Public Health Service Act establishes a Federal rule of 
     law applicable to a civil action brought for a smallpox 
     vaccine-related injury or death--
       (A) this title shall not affect the application of the rule 
     of law to such an action; and
       (B) any rule of law prescribed by this title in conflict 
     with a rule of law of such part C shall not apply to such 
     action.
       (2) Exception.--If there is an aspect of a civil action 
     brought for a smallpox vaccine-related injury or death to 
     which a Federal rule of law under part C of title II of the 
     Public Health Service Act does not apply, then this title or 
     otherwise applicable law (as determined under this title) 
     will apply to such aspect of such action.
       (c) Other Federal Law.--Except as provided in this section, 
     nothing in this title shall be deemed to affect any defense 
     available, or any limitation on liability that applies to, a 
     defendant in a health care lawsuit or action under any other 
     provision of Federal law.

     SEC. _10. STATE FLEXIBILITY AND PROTECTION OF STATES' RIGHTS.

       (a) Health Care Lawsuits.--The provisions governing health 
     care lawsuits set forth in this title shall preempt, subject 
     to subsections (b) and (c), State law to the extent that 
     State law prevents the application of any provisions of law 
     established by or under this title. The provisions governing 
     health care lawsuits set forth in this title supersede 
     chapter 171 of title 28, United States Code, to the extent 
     that such chapter--
       (1) provides for a greater amount of damages or contingent 
     fees, a longer period in which a health care lawsuit may be 
     commenced, or a reduced applicability or scope of periodic 
     payment of future damages, than provided in this title; or

[[Page 4923]]

       (2) prohibits the introduction of evidence regarding 
     collateral source benefits.
       (b) Preemption of Certain State Laws.--No provision of this 
     title shall be construed to preempt any State law (whether 
     effective before, on, or after the date of the enactment of 
     this title) that specifies a particular monetary amount of 
     compensatory or punitive damages (or the total amount of 
     damages) that may be awarded in a health care lawsuit, 
     regardless of whether such monetary amount is greater or 
     lesser than is provided for under this title, notwithstanding 
     section __4(a).
       (c) Protection of State's Rights and Other Laws.--
       (1) In general.--Any issue that is not governed by a 
     provision of law established by or under this title 
     (including the State standards of negligence) shall be 
     governed by otherwise applicable Federal or State law.
       (2) Rule of construction.--Nothing in this title shall be 
     construed to--
       (A) preempt or supersede any Federal or State law that 
     imposes greater procedural or substantive protections (such 
     as a shorter statute of limitations) for a health care 
     provider or health care institution from liability, loss, or 
     damages than those provided by this title;
       (B) preempt or supercede any State law that permits and 
     provides for the enforcement of any arbitration agreement 
     related to a health care liability claim whether enacted 
     prior to or after the date of enactment of this title;
       (C) create a cause of action that is not otherwise 
     available under Federal or State law; or
       (D) affect the scope of preemption of any other Federal 
     law.

     SEC. _11. APPLICABILITY; EFFECTIVE DATE.

       This title shall apply to any health care lawsuit brought 
     in a Federal or State court, or subject to an alternative 
     dispute resolution system, that is initiated on or after the 
     date of the enactment of this title, except that any health 
     care lawsuit arising from an injury occurring prior to the 
     date of enactment of this title shall be governed by the 
     applicable statute of limitations provisions in effect at the 
     time the injury occurred.
                                 ______
                                 
  SA 3681. Mr. BUNNING submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

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

     SEC. __. ALLOWING INDIVIDUALS TO ELECT TO OPT OUT OF THE 
                   MEDICARE PART A BENEFIT.

       Notwithstanding any other provision of law, in the case of 
     an individual who elects to opt out of benefits under part A 
     of title XVIII of the Social Security Act, such individual 
     shall not be required to--
       (1) opt out of benefits under title II of such Act as a 
     condition for making such election; and
       (2) repay any amount paid under such part A for items and 
     services furnished prior to making such election.
                                 ______
                                 
  SA 3682. Mr. McCAIN (for himself and Mr. Kyl) submitted an amendment 
intended to be proposed by him to the bill H.R. 4872, to provide for 
reconciliation pursuant to Title II of the concurrent resolution on the 
budget for fiscal year 2010 (S. Con. Res. 13); which was ordered to lie 
on the table; as follows:

       On page 113, after line 21, insert the following:

     SEC. 1502. COMPENSATION TO STATES FOR APPLYING DAVIS-BACON 
                   WAGE REQUIREMENTS TO CERTAIN WATER TREATMENT 
                   PROJECTS.

       (a) In General.--The Administrator of the Environmental 
     Protection Agency shall compensate States for any increased 
     administrative and project labor costs incurred by the States 
     as the result of the provisions of title II of the Department 
     of the Interior, Environment, and Related Agencies 
     Appropriations Act, 2010 (Public Law 111-88), that apply the 
     provisions of subchapter IV of chapter 31 of part A of 
     subtitle II of title 40, United States Code (commonly 
     referred to as the ``Davis-Bacon Act''), to any projects 
     carried out, in whole or in part, with assistance made 
     available from the State drinking water treatment revolving 
     loan funds established under section 1452 of the Safe 
     Drinking Water Act (42 U.S.C. 300j-12) or State water 
     pollution control revolving funds established under title VI 
     of the Federal Water Pollution Control Act (33 U.S.C. 1381 et 
     seq.).
       (b) Offset.--Any amounts otherwise made available to pay 
     the salaries and expenses of the Office of the Administrator 
     of the Environmental Protection Agency shall be reduced by 
     the amount necessary to carry out subsection (a).
                                 ______
                                 
  SA 3683. Mr. THUNE submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 113, after line 21, insert the following:

     SEC. __. FAIL-SAFE MECHANISM TO PREVENT INCREASE IN FEDERAL 
                   BUDGET DEFICIT.

       (a) Estimate and Certification of Effect of Patient 
     Protection and Affordable Care Act and This Act on Budget 
     Deficit.--
       (1) In general.--The President shall include in the 
     submission under section 1105 of title 31, United States 
     Code, of the budget of the United States Government for 
     fiscal year 2013 and each fiscal year thereafter an estimate 
     of the budgetary effects for the fiscal year of the 
     provisions of (and the amendments made by) the Patient 
     Protection and Affordable Care Act and this Act, based on the 
     information available as of the date of such submission.
       (2) Certification.--The President shall include with the 
     estimate under paragraph (1) for any fiscal year a 
     certification as to whether the sum of the decreases in 
     revenues and increases in outlays for the fiscal year by 
     reason of the provisions of (and the amendments made by) the 
     Patient Protection and Affordable Care Act and this Act 
     exceed (or do not exceed) the sum of the increases in 
     revenues and decreases in outlays for the fiscal year by 
     reason of the provisions and amendments.
       (b) Effect of Deficit.--If the President certifies an 
     excess under subsection (a)(2) for any fiscal year--
       (1) the President shall include with the certification the 
     percentage by which the credits allowable under section 36B 
     of the Internal Revenue Code of 1986 and the cost-sharing 
     subsidies under section 1402 of the Patient Protection and 
     Affordable Care Act must be reduced for plan years beginning 
     during such fiscal year such that there is an aggregate 
     decrease in the amount of such credits and subsidies equal to 
     the amount of such excess; and
       (2) the President shall instruct the Secretary of Health 
     and Human Services and the Secretary of the Treasury to 
     reduce such credits and subsidies for such plan years by such 
     percentage.
       (c) Expansion of Affordability Exception to Individual 
     Mandate.--Section 5000A(e)(1)(A) of the Internal Revenue Code 
     of 1986, as added by section 1501(b) of the Patient 
     Protection and Affordable Care Act, is amended by striking 
     ``8 percent'' and inserting ``5 percent''.
                                 ______
                                 
  SA 3684. Mr. BROWNBACK submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       Strike section 1202 and insert the following:

     SEC. 1202. PAYMENTS TO PRIMARY CARE PROVIDERS.

       (a) Grants to States To Increase Payments.--From the 
     amounts appropriated under subsection (b), the Secretary of 
     Health and Human Services shall award grants to States with 
     an approved State plan amendment under the Medicaid program 
     under title XIX of the Social Security Act to permanently 
     increase payment rates to primary care providers under the 
     State Medicaid program above the rates applicable under the 
     State Medicaid program on the date of enactment of this Act. 
     Funds paid to a State from such a grant shall only be used 
     for expenditures attributable to the additional amounts paid 
     to such providers as a result of the increase in such rates.
       (b) Appropriation.--Out of any funds in the Treasury not 
     otherwise appropriated, there is appropriated to the 
     Secretary of Health and Human Services, $8,000,000,000, to 
     remain available until expended.
       (c) Effective Date.--This section shall take effect on 
     January 1, 2013.
                                 ______
                                 
  SA 3685. Mr. BROWNBACK (for himself and Mr. Roberts) submitted an 
amendment intended to be proposed by him to the bill H.R. 4872, to 
provide for reconciliation pursuant to Title II of the concurrent 
resolution on the budget for fiscal year 2010 (S. Con. Res. 13); which 
was ordered to lie on the table; as follows:

       On page 61, after line 3, insert the following:

     SEC. ___. RESTORING STATE AUTHORITY TO WAIVE THE 35-MILE RULE 
                   FOR MEDICARE CRITICAL ACCESS HOSPITAL 
                   DESIGNATIONS.

       (a) In General.--Section 1820(c)(2)(B)(i)(II) of the Social 
     Security Act (42 U.S.C. 1395i-4(c)(2)(B)(i)(II)) is amended 
     by inserting ``or on or after the date of enactment of the 
     Health Care and Education Reconciliation Act of 2010'' after 
     ``January 1, 2006,''.
       (b) Expansion of Affordability Exception to Individual 
     Mandate.--Section 5000A(e)(1)(A) of the Internal Revenue Code 
     of 1986, as added by section 1501(b) of the Patient 
     Protection and Affordable Care Act, is

[[Page 4924]]

     amended by striking ``8 percent'' and inserting ``5 
     percent''.
                                 ______
                                 
  SA 3686. Mr. BROWNBACK submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

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

     SEC. 1207. INCREASING THE TRANSPARENCY OF INFORMATION ON 
                   HOSPITAL CHARGES AND MAKING AVAILABLE 
                   INFORMATION ON ESTIMATED OUT-OF-POCKET COSTS 
                   FOR HEALTH CARE SERVICES.

       (a) In General.--Section 1902(a) of the Social Security Act 
     (42 U.S.C. 1396a(a)), as amended by section 3021(b) of the 
     Patient Protection and Affordable Care Act, is amended--
       (1) by striking ``and'' at the end of paragraph (82);
       (2) by striking the period at the end of paragraph (83) and 
     inserting ``; and'';
       (3) by inserting after paragraph (83) the following new 
     paragraph:
       ``(84) provide that the State will establish and maintain 
     laws, in accordance with the requirements of section 1921A, 
     to require disclosure of information on hospital charges, to 
     make such information available to the public, and to provide 
     individuals with information about estimated out-of-pocket 
     costs for health care services.''; and
       (4) by inserting after section 1921 the following new 
     section:


 ``increasing the transparency of information on hospital charges and 
 providing consumers with estimates of out-of-pocket costs for health 
                             care services

       ``Sec. 1921A.  (a) In General.--The requirements referred 
     to in section 1902(a)(84) are that the laws of a State must--
       ``(1) in accordance with subsection (b)--
       ``(A) require the disclosure of information on hospital 
     charges; and
       ``(B) provide for access to such information; and
       ``(2) in accordance with subsection (c), require the 
     provision of a statement of the estimated out-of-pocket costs 
     of an individual for anticipated future health care services.
       ``(b) Information on Hospital Charges.--The laws of a State 
     must--
       ``(1) require disclosure, by each hospital located in the 
     State, of information on the charges for certain inpatient 
     and outpatient hospital services (as determined by the State) 
     provided at the hospital; and
       ``(2) provide for timely access to such information by 
     individuals seeking or requiring such services.
       ``(c) Estimated Out-of-Pocket Costs.--The laws of a State 
     must require that, upon the request of any individual with 
     health insurance coverage sponsored by a health insurance 
     issuer, the issuer must provide a statement of the estimated 
     out-of-pocket costs that are likely to be incurred by the 
     individual if the individual receives particular health care 
     items and services within a specified period of time.
       ``(d) Rules of Construction.--Nothing in this section shall 
     be construed as--
       ``(1) authorizing or requiring the Secretary to establish 
     uniform standards for the State laws required by subsections 
     (b) and (c);
       ``(2) requiring any State with a law enacted on or before 
     the date of the enactment of this section that--
       ``(A) meets the requirements of subsection (b) or 
     subsection (c) to modify or amend such law; or
       ``(B) meets some but not all of the requirements of 
     subsection (b) or subsection (c) to modify or amend such law 
     except to the extent necessary to address the unmet 
     requirements;
       ``(3) precluding any State in which a program of voluntary 
     disclosure of information on hospital charges is in effect 
     from adopting a law codifying such program (other than its 
     voluntary nature) to satisfy the requirement of subsection 
     (b)(1); or
       ``(4) guaranteeing that the out-of-pocket costs of an 
     individual will not exceed the estimate of such costs 
     provided pursuant to subsection (c).
       ``(e) Definitions.--For purposes of this section:
       ``(1) The term `health insurance coverage' has the meaning 
     given such term in section 2791(b)(1) of the Public Health 
     Service Act.
       ``(2) The term `health insurance issuer' has the meaning 
     given such term in section 2791(b)(2) of the Public Health 
     Service Act, except that such term also includes--
       ``(A) a Medicaid managed care organization (as defined in 
     section 1903(m)); and
       ``(B) a Medicare Advantage organization (as defined in 
     1859(a)(1), taking into account the operation of section 
     201(b) of the Medicare Prescription Drug, Improvement, and 
     Modernization Act of 2003).

     Section 1856(b)(3) shall not preclude the application to a 
     Medicare Advantage organization or a Medicare Advantage plan 
     offered by such an organization of any State law adopted to 
     carry out the requirements of subsection (b) or (c).
       ``(3) The term `hospital' means an institution that meets 
     the requirements of paragraphs (1) and (7) of section 1861(e) 
     and includes those to which section 1820(c) applies.''.
       (b) Effective Date.--
       (1) In general.--Except as provided in paragraph (2), the 
     amendments made by subsection (a) shall take effect on 
     October 1, 2010.
       (2) Exception.--In the case of a State plan for medical 
     assistance under title XIX of the Social Security Act which 
     the Secretary of Health and Human Services determines 
     requires State legislation (other than legislation 
     appropriating funds) in order for the plan to meet the 
     additional requirements imposed by the amendment made by 
     subsection (a), the State plan shall not be regarded as 
     failing to comply with the requirements of such title solely 
     on the basis of its failure to meet these additional 
     requirements before the first day of the first calendar 
     quarter beginning after the close of the first regular 
     session of the State legislature that begins after the date 
     of the enactment of this Act. For purposes of the previous 
     sentence, in the case of a State that has a 2-year 
     legislative session, each year of such session shall be 
     deemed to be a separate regular session of the State 
     legislature.
                                 ______
                                 
  SA 3687. Mr. COBURN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. ____. CONDITIONS FOR TREATMENT OF CERTAIN PERSONS AS 
                   ADJUDICATED MENTALLY INCOMPETENT FOR CERTAIN 
                   PURPOSES.

       (a) In General.--Chapter 55 of title 38, United States 
     Code, is amended by adding at the end the following new 
     section:

     ``Sec. 5511. Conditions for treatment of certain persons as 
       adjudicated mentally incompetent for certain purposes

       ``In any case arising out of the administration by the 
     Secretary of laws and benefits under this title, a person who 
     is mentally incapacitated, deemed mentally incompetent, or 
     experiencing an extended loss of consciousness shall not be 
     considered adjudicated as a mental defective under subsection 
     (d)(4) or (g)(4) of section 922 of title 18 without the order 
     or finding of a judge, magistrate, or other judicial 
     authority of competent jurisdiction that such person is a 
     danger to himself or herself or others.''.
       (b) Clerical Amendment.--The table of sections at the 
     beginning of chapter 55 of such title is amended by adding at 
     the end the following new item:

       ``5511. Conditions for treatment of certain persons as 
           adjudicated mentally incompetent for certain 
           purposes.''.
                                 ______
                                 
  SA 3688. Ms. SNOWE (for herself, Mr. McCain, Mr. Vitter, Mr. Thune, 
Mr. Grassley, and Ms. Collins) submitted an amendment intended to be 
proposed by her to the bill H.R. 4872, to provide for reconciliation 
pursuant to Title II of the concurrent resolution on the budget for 
fiscal year 2010 (S. Con. Res. 13); which was ordered to lie on the 
table; as follows:

       At the end, add the following:

              TITLE III--IMPORTATION OF PRESCRIPTION DRUGS

     SEC. 3001. SHORT TITLE.

       This title may be cited as the ``Pharmaceutical Market 
     Access and Drug Safety Act of 2010''.

     SEC. 3002. FINDINGS.

       Congress finds that--
       (1) Americans unjustly pay up to 5 times more to fill their 
     prescriptions than consumers in other countries;
       (2) the United States is the largest market for 
     pharmaceuticals in the world, yet American consumers pay the 
     highest prices for brand pharmaceuticals in the world;
       (3) a prescription drug is neither safe nor effective to an 
     individual who cannot afford it;
       (4) allowing and structuring the importation of 
     prescription drugs to ensure access to safe and affordable 
     drugs approved by the Food and Drug Administration will 
     provide a level of safety to American consumers that they do 
     not currently enjoy;
       (5) American spend more than $200,000,000,000 on 
     prescription drugs every year;
       (6) the Congressional Budget Office has found that the cost 
     of prescription drugs are between 35 to 55 percent less in 
     other highly-developed countries than in the United States; 
     and
       (7) promoting competitive market pricing would both 
     contribute to health care savings and allow greater access to 
     therapy, improving health and saving lives.

     SEC. 3003. REPEAL OF CERTAIN SECTION REGARDING IMPORTATION OF 
                   PRESCRIPTION DRUGS.

       Chapter VIII of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 381 et seq.) is amended by striking section 804.

[[Page 4925]]



     SEC. 3004. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER OF 
                   CERTAIN IMPORT RESTRICTIONS.

       (a) In General.--Chapter VIII of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381 et seq.), as amended by 
     section 3003, is further amended by inserting after section 
     803 the following:

     ``SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF 
                   PRESCRIPTION DRUGS.

       ``(a) Importation of Prescription Drugs.--
       ``(1) In general.--In the case of qualifying drugs imported 
     or offered for import into the United States from registered 
     exporters or by registered importers--
       ``(A) the limitation on importation that is established in 
     section 801(d)(1) is waived; and
       ``(B) the standards referred to in section 801(a) regarding 
     admission of the drugs are subject to subsection (g) of this 
     section (including with respect to qualifying drugs to which 
     section 801(d)(1) does not apply).
       ``(2) Importers.--A qualifying drug may not be imported 
     under paragraph (1) unless--
       ``(A) the drug is imported by a pharmacy, group of 
     pharmacies, or a wholesaler that is a registered importer; or
       ``(B) the drug is imported by an individual for personal 
     use or for the use of a family member of the individual (not 
     for resale) from a registered exporter.
       ``(3) Rule of construction.--This section shall apply only 
     with respect to a drug that is imported or offered for import 
     into the United States--
       ``(A) by a registered importer; or
       ``(B) from a registered exporter to an individual.
       ``(4) Definitions.--
       ``(A) Registered exporter; registered importer.--For 
     purposes of this section:
       ``(i) The term `registered exporter' means an exporter for 
     which a registration under subsection (b) has been approved 
     and is in effect.
       ``(ii) The term `registered importer' means a pharmacy, 
     group of pharmacies, or a wholesaler for which a registration 
     under subsection (b) has been approved and is in effect.
       ``(iii) The term `registration condition' means a condition 
     that must exist for a registration under subsection (b) to be 
     approved.
       ``(B) Qualifying drug.--For purposes of this section, the 
     term `qualifying drug' means a drug for which there is a 
     corresponding U.S. label drug.
       ``(C) U.S. label drug.--For purposes of this section, the 
     term `U.S. label drug' means a prescription drug that--
       ``(i) with respect to a qualifying drug, has the same 
     active ingredient or ingredients, route of administration, 
     dosage form, and strength as the qualifying drug;
       ``(ii) with respect to the qualifying drug, is manufactured 
     by or for the person that manufactures the qualifying drug;
       ``(iii) is approved under section 505(c); and
       ``(iv) is not--

       ``(I) a controlled substance, as defined in section 102 of 
     the Controlled Substances Act (21 U.S.C. 802);
       ``(II) a biological product, as defined in section 351 of 
     the Public Health Service Act (42 U.S.C. 262), including--

       ``(aa) a therapeutic DNA plasmid product;
       ``(bb) a therapeutic synthetic peptide product;
       ``(cc) a monoclonal antibody product for in vivo use; and
       ``(dd) a therapeutic recombinant DNA-derived product;

       ``(III) an infused drug, including a peritoneal dialysis 
     solution;
       ``(IV) an injected drug;
       ``(V) a drug that is inhaled during surgery;
       ``(VI) a drug that is the listed drug referred to in 2 or 
     more abbreviated new drug applications under which the drug 
     is commercially marketed; or
       ``(VII) a sterile opthlamic drug intended for topical use 
     on or in the eye.

       ``(D) Other definitions.--For purposes of this section:
       ``(i)(I) The term `exporter' means a person that is in the 
     business of exporting a drug to individuals in the United 
     States from Canada or from a permitted country designated by 
     the Secretary under subclause (II), or that, pursuant to 
     submitting a registration under subsection (b), seeks to be 
     in such business.
       ``(II) The Secretary shall designate a permitted country 
     under subparagraph (E) (other than Canada) as a country from 
     which an exporter may export a drug to individuals in the 
     United States if the Secretary determines that--

       ``(aa) the country has statutory or regulatory standards 
     that are equivalent to the standards in the United States and 
     Canada with respect to--

       ``(AA) the training of pharmacists;
       ``(BB) the practice of pharmacy; and
       ``(CC) the protection of the privacy of personal medical 
     information; and

       ``(bb) the importation of drugs to individuals in the 
     United States from the country will not adversely affect 
     public health.

       ``(ii) The term `importer' means a pharmacy, a group of 
     pharmacies, or a wholesaler that is in the business of 
     importing a drug into the United States or that, pursuant to 
     submitting a registration under subsection (b), seeks to be 
     in such business.
       ``(iii) The term `pharmacist' means a person licensed by a 
     State to practice pharmacy, including the dispensing and 
     selling of prescription drugs.
       ``(iv) The term `pharmacy' means a person that--

       ``(I) is licensed by a State to engage in the business of 
     selling prescription drugs at retail; and
       ``(II) employs 1 or more pharmacists.

       ``(v) The term `prescription drug' means a drug that is 
     described in section 503(b)(1).
       ``(vi) The term `wholesaler'--

       ``(I) means a person licensed as a wholesaler or 
     distributor of prescription drugs in the United States under 
     section 503(e)(2)(A); and
       ``(II) does not include a person authorized to import drugs 
     under section 801(d)(1).

       ``(E) Permitted country.--The term `permitted country' 
     means--
       ``(i) Australia;
       ``(ii) Canada;
       ``(iii) a member country of the European Union, but does 
     not include a member country with respect to which--

       ``(I) the country's Annex to the Treaty of Accession to the 
     European Union 2003 includes a transitional measure for the 
     regulation of human pharmaceutical products that has not 
     expired; or
       ``(II) the Secretary determines that the requirements 
     described in subclauses (I) and (II) of clause (vii) will not 
     be met by the date on which such transitional measure for the 
     regulation of human pharmaceutical products expires;

       ``(iv) Japan;
       ``(v) New Zealand;
       ``(vi) Switzerland; and
       ``(vii) a country in which the Secretary determines the 
     following requirements are met:

       ``(I) The country has statutory or regulatory 
     requirements--

       ``(aa) that require the review of drugs for safety and 
     effectiveness by an entity of the government of the country;
       ``(bb) that authorize the approval of only those drugs that 
     have been determined to be safe and effective by experts 
     employed by or acting on behalf of such entity and qualified 
     by scientific training and experience to evaluate the safety 
     and effectiveness of drugs on the basis of adequate and well-
     controlled investigations, including clinical investigations, 
     conducted by experts qualified by scientific training and 
     experience to evaluate the safety and effectiveness of drugs;
       ``(cc) that require the methods used in, and the facilities 
     and controls used for the manufacture, processing, and 
     packing of drugs in the country to be adequate to preserve 
     their identity, quality, purity, and strength;
       ``(dd) for the reporting of adverse reactions to drugs and 
     procedures to withdraw approval and remove drugs found not to 
     be safe or effective; and
       ``(ee) that require the labeling and promotion of drugs to 
     be in accordance with the approval of the drug.

       ``(II) The valid marketing authorization system in the 
     country is equivalent to the systems in the countries 
     described in clauses (i) through (vi).
       ``(III) The importation of drugs to the United States from 
     the country will not adversely affect public health.

       ``(b) Registration of Importers and Exporters.--
       ``(1) Registration of importers and exporters.--A 
     registration condition is that the importer or exporter 
     involved (referred to in this subsection as a `registrant') 
     submits to the Secretary a registration containing the 
     following:
       ``(A)(i) In the case of an exporter, the name of the 
     exporter and an identification of all places of business of 
     the exporter that relate to qualifying drugs, including each 
     warehouse or other facility owned or controlled by, or 
     operated for, the exporter.
       ``(ii) In the case of an importer, the name of the importer 
     and an identification of the places of business of the 
     importer at which the importer initially receives a 
     qualifying drug after importation (which shall not exceed 3 
     places of business except by permission of the Secretary).
       ``(B) Such information as the Secretary determines to be 
     necessary to demonstrate that the registrant is in compliance 
     with registration conditions under--
       ``(i) in the case of an importer, subsections (c), (d), 
     (e), (g), and (j) (relating to the sources of imported 
     qualifying drugs; the inspection of facilities of the 
     importer; the payment of fees; compliance with the standards 
     referred to in section 801(a); and maintenance of records and 
     samples); or
       ``(ii) in the case of an exporter, subsections (c), (d), 
     (f), (g), (h), (i), and (j) (relating to the sources of 
     exported qualifying drugs; the inspection of facilities of 
     the exporter and the marking of compliant shipments; the 
     payment of fees; and compliance with the standards referred 
     to in section 801(a); being licensed as a pharmacist; 
     conditions for individual importation; and maintenance of 
     records and samples).
       ``(C) An agreement by the registrant that the registrant 
     will not under subsection (a) import or export any drug that 
     is not a qualifying drug.
       ``(D) An agreement by the registrant to--
       ``(i) notify the Secretary of a recall or withdrawal of a 
     qualifying drug distributed

[[Page 4926]]

     in a permitted country that the registrant has exported or 
     imported, or intends to export or import, to the United 
     States under subsection (a);
       ``(ii) provide for the return to the registrant of such 
     drug; and
       ``(iii) cease, or not begin, the exportation or importation 
     of such drug unless the Secretary has notified the registrant 
     that exportation or importation of such drug may proceed.
       ``(E) An agreement by the registrant to ensure and monitor 
     compliance with each registration condition, to promptly 
     correct any noncompliance with such a condition, and to 
     promptly report to the Secretary any such noncompliance.
       ``(F) A plan describing the manner in which the registrant 
     will comply with the agreement under subparagraph (E).
       ``(G) An agreement by the registrant to enforce a contract 
     under subsection (c)(3)(B) against a party in the chain of 
     custody of a qualifying drug with respect to the authority of 
     the Secretary under clauses (ii) and (iii) of that 
     subsection.
       ``(H) An agreement by the registrant to notify the 
     Secretary not more than 30 days before the registrant intends 
     to make the change, of--
       ``(i) any change that the registrant intends to make 
     regarding information provided under subparagraph (A) or (B); 
     and
       ``(ii) any change that the registrant intends to make in 
     the compliance plan under subparagraph (F).
       ``(I) In the case of an exporter:
       ``(i) An agreement by the exporter that a qualifying drug 
     will not under subsection (a) be exported to any individual 
     not authorized pursuant to subsection (a)(2)(B) to be an 
     importer of such drug.
       ``(ii) An agreement to post a bond, payable to the Treasury 
     of the United States that is equal in value to the lesser 
     of--

       ``(I) the value of drugs exported by the exporter to the 
     United States in a typical 4-week period over the course of a 
     year under this section; or
       ``(II) $1,000,000.

       ``(iii) An agreement by the exporter to comply with 
     applicable provisions of Canadian law, or the law of the 
     permitted country designated under subsection 
     (a)(4)(D)(i)(II) in which the exporter is located, that 
     protect the privacy of personal information with respect to 
     each individual importing a prescription drug from the 
     exporter under subsection (a)(2)(B).
       ``(iv) An agreement by the exporter to report to the 
     Secretary--

       ``(I) not later than August 1 of each fiscal year, the 
     total price and the total volume of drugs exported to the 
     United States by the exporter during the 6-month period from 
     January 1 through June 30 of that year; and
       ``(II) not later than January 1 of each fiscal year, the 
     total price and the total volume of drugs exported to the 
     United States by the exporter during the previous fiscal 
     year.

       ``(J) In the case of an importer, an agreement by the 
     importer to report to the Secretary--
       ``(i) not later than August 1 of each fiscal year, the 
     total price and the total volume of drugs imported to the 
     United States by the importer during the 6-month period from 
     January 1 through June 30 of that fiscal year; and
       ``(ii) not later than January 1 of each fiscal year, the 
     total price and the total volume of drugs imported to the 
     United States by the importer during the previous fiscal 
     year.
       ``(K) Such other provisions as the Secretary may require by 
     regulation to protect the public health while permitting--
       ``(i) the importation by pharmacies, groups of pharmacies, 
     and wholesalers as registered importers of qualifying drugs 
     under subsection (a); and
       ``(ii) importation by individuals of qualifying drugs under 
     subsection (a).
       ``(2) Approval or disapproval of registration.--
       ``(A) In general.--Not later than 90 days after the date on 
     which a registrant submits to the Secretary a registration 
     under paragraph (1), the Secretary shall notify the 
     registrant whether the registration is approved or is 
     disapproved. The Secretary shall disapprove a registration if 
     there is reason to believe that the registrant is not in 
     compliance with one or more registration conditions, and 
     shall notify the registrant of such reason. In the case of a 
     disapproved registration, the Secretary shall subsequently 
     notify the registrant that the registration is approved if 
     the Secretary determines that the registrant is in compliance 
     with such conditions.
       ``(B) Changes in registration information.--Not later than 
     30 days after receiving a notice under paragraph (1)(H) from 
     a registrant, the Secretary shall determine whether the 
     change involved affects the approval of the registration of 
     the registrant under paragraph (1), and shall inform the 
     registrant of the determination.
       ``(3) Publication of contact information for registered 
     exporters.--Through the Internet website of the Food and Drug 
     Administration and a toll-free telephone number, the 
     Secretary shall make readily available to the public a list 
     of registered exporters, including contact information for 
     the exporters. Promptly after the approval of a registration 
     submitted under paragraph (1), the Secretary shall update the 
     Internet website and the information provided through the 
     toll-free telephone number accordingly.
       ``(4) Suspension and termination.--
       ``(A) Suspension.--With respect to the effectiveness of a 
     registration submitted under paragraph (1):
       ``(i) Subject to clause (ii), the Secretary may suspend the 
     registration if the Secretary determines, after notice and 
     opportunity for a hearing, that the registrant has failed to 
     maintain substantial compliance with a registration 
     condition.
       ``(ii) If the Secretary determines that, under color of the 
     registration, the exporter has exported a drug or the 
     importer has imported a drug that is not a qualifying drug, 
     or a drug that does not comply with subsection (g)(2)(A) or 
     (g)(4), or has exported a qualifying drug to an individual in 
     violation of subsection (i), 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 
     registrant 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 registrant 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 paragraph (1) of a registrant if the Secretary 
     determines that the registrant 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 
     registrant. 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 is terminated, any 
     registration submitted under paragraph (1) by the registrant, 
     or a person that is a partner in the export or import 
     enterprise, or a principal officer in such enterprise, and 
     any registration prepared with the assistance of the 
     registrant or such a person, has no legal effect under this 
     section.
       ``(5) Default of bond.--A bond required to be posted by an 
     exporter under paragraph (1)(I)(ii) shall be defaulted and 
     paid to the Treasury of the United States if, after 
     opportunity for an informal hearing, the Secretary determines 
     that the exporter has--
       ``(A) exported a drug to the United States that is not a 
     qualifying drug or that is not in compliance with subsection 
     (g)(2)(A), (g)(4), or (i); or
       ``(B) failed to permit the Secretary to conduct an 
     inspection described under subsection (d).
       ``(c) Sources of Qualifying Drugs.--A registration 
     condition is that the exporter or importer involved agrees 
     that a qualifying drug will under subsection (a) be exported 
     or imported into the United States only if there is 
     compliance with the following:
       ``(1) The drug was manufactured in an establishment--
       ``(A) required to register under subsection (h) or (i) of 
     section 510; and
       ``(B)(i) inspected by the Secretary; or
       ``(ii) for which the Secretary has elected to rely on a 
     satisfactory report of a good manufacturing practice 
     inspection of the establishment from a permitted country 
     whose regulatory system the Secretary recognizes as 
     equivalent under a mutual recognition agreement, as provided 
     for under section 510(i)(3), section 803, or part 26 of title 
     21, Code of Federal Regulations (or any corresponding 
     successor rule or regulation).
       ``(2) The establishment is located in any country, and the 
     establishment manufactured the drug for distribution in the 
     United States or for distribution in 1 or more of the 
     permitted countries (without regard to whether in addition 
     the drug is manufactured for distribution in a foreign 
     country that is not a permitted country).
       ``(3) The exporter or importer obtained the drug--
       ``(A) directly from the establishment; or
       ``(B) directly from an entity that, by contract with the 
     exporter or importer--
       ``(i) provides to the exporter or importer a statement (in 
     such form and containing such information as the Secretary 
     may require) that, for the chain of custody from the 
     establishment, identifies each prior sale, purchase, or trade 
     of the drug (including the date of the transaction and the 
     names and addresses of all parties to the transaction);
       ``(ii) agrees to permit the Secretary to inspect such 
     statements and related records to determine their accuracy;
       ``(iii) agrees, with respect to the qualifying drugs 
     involved, to permit the Secretary to inspect warehouses and 
     other facilities, including records, of the entity for 
     purposes of determining whether the facilities are in 
     compliance with any standards under this Act that are 
     applicable to facilities of that type in the United States; 
     and
       ``(iv) has ensured, through such contractual relationships 
     as may be necessary, that the Secretary has the same 
     authority regarding other parties in the chain of custody

[[Page 4927]]

     from the establishment that the Secretary has under clauses 
     (ii) and (iii) regarding such entity.
       ``(4)(A) The foreign country from which the importer will 
     import the drug is a permitted country; or
       ``(B) The foreign country from which the exporter will 
     export the drug is the permitted country in which the 
     exporter is located.
       ``(5) During any period in which the drug was not in the 
     control of the manufacturer of the drug, the drug did not 
     enter any country that is not a permitted country.
       ``(6) The exporter or importer retains a sample of each lot 
     of the drug for testing by the Secretary.
       ``(d) Inspection of Facilities; Marking of Shipments.--
       ``(1) Inspection of facilities.--A registration condition 
     is that, for the purpose of assisting the Secretary in 
     determining whether the exporter involved is in compliance 
     with all other registration conditions--
       ``(A) the exporter agrees to permit the Secretary--
       ``(i) to conduct onsite inspections, including monitoring 
     on a day-to-day basis, of places of business of the exporter 
     that relate to qualifying drugs, including each warehouse or 
     other facility owned or controlled by, or operated for, the 
     exporter;
       ``(ii) to have access, including on a day-to-day basis, 
     to--

       ``(I) records of the exporter that relate to the export of 
     such drugs, including financial records; and
       ``(II) samples of such drugs;

       ``(iii) to carry out the duties described in paragraph (3); 
     and
       ``(iv) to carry out any other functions determined by the 
     Secretary to be necessary regarding the compliance of the 
     exporter; and
       ``(B) the Secretary has assigned 1 or more employees of the 
     Secretary to carry out the functions described in this 
     subsection for the Secretary randomly, but not less than 12 
     times annually, on the premises of places of businesses 
     referred to in subparagraph (A)(i), and such an assignment 
     remains in effect on a continuous basis.
       ``(2) Marking of compliant shipments.--A registration 
     condition is that the exporter involved agrees to affix to 
     each shipping container of qualifying drugs exported under 
     subsection (a) such markings as the Secretary determines to 
     be necessary to identify the shipment as being in compliance 
     with all registration conditions. Markings under the 
     preceding sentence shall--
       ``(A) be designed to prevent affixation of the markings to 
     any shipping container that is not authorized to bear the 
     markings; and
       ``(B) include anticounterfeiting or track-and-trace 
     technologies, taking into account the economic and technical 
     feasibility of those technologies.
       ``(3) Certain duties relating to exporters.--Duties of the 
     Secretary with respect to an exporter include the following:
       ``(A) Inspecting, randomly, but not less than 12 times 
     annually, the places of business of the exporter at which 
     qualifying drugs are stored and from which qualifying drugs 
     are shipped.
       ``(B) During the inspections under subparagraph (A), 
     verifying the chain of custody of a statistically significant 
     sample of qualifying drugs from the establishment in which 
     the drug was manufactured to the exporter, which shall be 
     accomplished or supplemented by the use of anticounterfeiting 
     or track-and-trace technologies, taking into account the 
     economic and technical feasibility of those technologies, 
     except that a drug that lacks such technologies from the 
     point of manufacture shall not for that reason be excluded 
     from importation by an exporter.
       ``(C) Randomly reviewing records of exports to individuals 
     for the purpose of determining whether the drugs are being 
     imported by the individuals in accordance with the conditions 
     under subsection (i). Such reviews shall be conducted in a 
     manner that will result in a statistically significant 
     determination of compliance with all such conditions.
       ``(D) Monitoring the affixing of markings under paragraph 
     (2).
       ``(E) Inspecting as the Secretary determines is necessary 
     the warehouses and other facilities, including records, of 
     other parties in the chain of custody of qualifying drugs.
       ``(F) Determining whether the exporter is in compliance 
     with all other registration conditions.
       ``(4) Prior notice of shipments.--A registration condition 
     is that, not less than 8 hours and not more than 5 days in 
     advance of the time of the importation of a shipment of 
     qualifying drugs, the importer involved agrees to submit to 
     the Secretary a notice with respect to the shipment of drugs 
     to be imported or offered for import into the United States 
     under subsection (a). A notice under the preceding sentence 
     shall include--
       ``(A) the name and complete contact information of the 
     person submitting the notice;
       ``(B) the name and complete contact information of the 
     importer involved;
       ``(C) the identity of the drug, including the established 
     name of the drug, the quantity of the drug, and the lot 
     number assigned by the manufacturer;
       ``(D) the identity of the manufacturer of the drug, 
     including the identity of the establishment at which the drug 
     was manufactured;
       ``(E) the country from which the drug is shipped;
       ``(F) the name and complete contact information for the 
     shipper of the drug;
       ``(G) anticipated arrival information, including the port 
     of arrival and crossing location within that port, and the 
     date and time;
       ``(H) a summary of the chain of custody of the drug from 
     the establishment in which the drug was manufactured to the 
     importer;
       ``(I) a declaration as to whether the Secretary has ordered 
     that importation of the drug from the permitted country cease 
     under subsection (g)(2)(C) or (D); and
       ``(J) such other information as the Secretary may require 
     by regulation.
       ``(5) Marking of compliant shipments.--A registration 
     condition is that the importer involved agrees, before 
     wholesale distribution (as defined in section 503(e)) of a 
     qualifying drug that has been imported under subsection (a), 
     to affix to each container of such drug such markings or 
     other technology as the Secretary determines necessary to 
     identify the shipment as being in compliance with all 
     registration conditions, except that the markings or other 
     technology shall not be required on a drug that bears 
     comparable, compatible markings or technology from the 
     manufacturer of the drug. Markings or other technology under 
     the preceding sentence shall--
       ``(A) be designed to prevent affixation of the markings or 
     other technology to any container that is not authorized to 
     bear the markings; and
       ``(B) shall include anticounterfeiting or track-and-trace 
     technologies, taking into account the economic and technical 
     feasibility of such technologies.
       ``(6) Certain duties relating to importers.--Duties of the 
     Secretary with respect to an importer include the following:
       ``(A) Inspecting, randomly, but not less than 12 times 
     annually, the places of business of the importer at which a 
     qualifying drug is initially received after importation.
       ``(B) During the inspections under subparagraph (A), 
     verifying the chain of custody of a statistically significant 
     sample of qualifying drugs from the establishment in which 
     the drug was manufactured to the importer, which shall be 
     accomplished or supplemented by the use of anticounterfeiting 
     or track-and-trace technologies, taking into account the 
     economic and technical feasibility of those technologies, 
     except that a drug that lacks such technologies from the 
     point of manufacture shall not for that reason be excluded 
     from importation by an importer.
       ``(C) Reviewing notices under paragraph (4).
       ``(D) Inspecting as the Secretary determines is necessary 
     the warehouses and other facilities, including records of 
     other parties in the chain of custody of qualifying drugs.
       ``(E) Determining whether the importer is in compliance 
     with all other registration conditions.
       ``(e) Importer Fees.--
       ``(1) Registration fee.--A registration condition is that 
     the importer involved pays to the Secretary a fee of $10,000 
     due on the date on which the importer first submits the 
     registration to the Secretary under subsection (b).
       ``(2) Inspection fee.--A registration condition is that the 
     importer involved pays a fee to the Secretary in accordance 
     with this subsection. Such fee shall be paid not later than 
     October 1 and April 1 of each fiscal year in the amount 
     provided for under paragraph (3).
       ``(3) Amount of inspection fee.--
       ``(A) Aggregate total of fees.--Not later than 30 days 
     before the start of each fiscal year, the Secretary, in 
     consultation with the Secretary of Homeland Security and the 
     Secretary of the Treasury, shall establish an aggregate total 
     of fees to be collected under paragraph (2) for importers for 
     that fiscal year that is sufficient, and not more than 
     necessary, to pay the costs for that fiscal year of 
     administering this section with respect to registered 
     importers, including the costs associated with--
       ``(i) inspecting the facilities of registered importers, 
     and of other entities in the chain of custody of a qualifying 
     drug as necessary, under subsection (d)(6);
       ``(ii) developing, implementing, and operating under such 
     subsection an electronic system for submission and review of 
     the notices required under subsection (d)(4) with respect to 
     shipments of qualifying drugs under subsection (a) to assess 
     compliance with all registration conditions when such 
     shipments are offered for import into the United States; and
       ``(iii) inspecting such shipments as necessary, when 
     offered for import into the United States to determine if 
     such a shipment should be refused admission under subsection 
     (g)(5).
       ``(B) Limitation.--Subject to subparagraph (C), the 
     aggregate total of fees collected under paragraph (2) for a 
     fiscal year shall not exceed 2.5 percent of the total price 
     of qualifying drugs imported during that fiscal year into the 
     United States by registered importers under subsection (a).
       ``(C) Total price of drugs.--
       ``(i) Estimate.--For the purposes of complying with the 
     limitation described in subparagraph (B) when establishing 
     under subparagraph (A) the aggregate total of fees to

[[Page 4928]]

     be collected under paragraph (2) for a fiscal year, the 
     Secretary shall estimate the total price of qualifying drugs 
     imported into the United States by registered importers 
     during that fiscal year by adding the total price of 
     qualifying drugs imported by each registered importer during 
     the 6-month period from January 1 through June 30 of the 
     previous fiscal year, as reported to the Secretary by each 
     registered importer under subsection (b)(1)(J).
       ``(ii) Calculation.--Not later than March 1 of the fiscal 
     year that follows the fiscal year for which the estimate 
     under clause (i) is made, the Secretary shall calculate the 
     total price of qualifying drugs imported into the United 
     States by registered importers during that fiscal year by 
     adding the total price of qualifying drugs imported by each 
     registered importer during that fiscal year, as reported to 
     the Secretary by each registered importer under subsection 
     (b)(1)(J).
       ``(iii) Adjustment.--If the total price of qualifying drugs 
     imported into the United States by registered importers 
     during a fiscal year as calculated under clause (ii) is less 
     than the aggregate total of fees collected under paragraph 
     (2) for that fiscal year, the Secretary shall provide for a 
     pro-rata reduction in the fee due from each registered 
     importer on April 1 of the subsequent fiscal year so that the 
     limitation described in subparagraph (B) is observed.
       ``(D) Individual importer fee.--Subject to the limitation 
     described in subparagraph (B), the fee under paragraph (2) to 
     be paid on October 1 and April 1 by an importer shall be an 
     amount that is proportional to a reasonable estimate by the 
     Secretary of the semiannual share of the importer of the 
     volume of qualifying drugs imported by importers under 
     subsection (a).
       ``(4) Use of fees.--
       ``(A) In general.--Fees collected by the Secretary under 
     paragraphs (1) and (2) shall be credited to the appropriation 
     account for salaries and expenses of the Food and Drug 
     Administration until expended (without fiscal year 
     limitation), and the Secretary may, in consultation with the 
     Secretary of Homeland Security and the Secretary of the 
     Treasury, transfer some proportion of such fees to the 
     appropriation account for salaries and expenses of the Bureau 
     of Customs and Border Protection until expended (without 
     fiscal year limitation).
       ``(B) Availability.--Fees collected by the Secretary under 
     paragraphs (1) and (2) shall be made available to the Food 
     and Drug Administration.
       ``(C) Sole purpose.--Fees collected by the Secretary under 
     paragraphs (1) and (2) are only available to the Secretary 
     and, if transferred, to the Secretary of Homeland Security, 
     and are for the sole purpose of paying the costs referred to 
     in paragraph (3)(A).
       ``(5) Collection of fees.--In any case where the Secretary 
     does not receive payment of a fee assessed under paragraph 
     (1) or (2) within 30 days after it is due, such fee shall be 
     treated as a claim of the United States Government subject to 
     subchapter II of chapter 37 of title 31, United States Code.
       ``(f) Exporter Fees.--
       ``(1) Registration fee.--A registration condition is that 
     the exporter involved pays to the Secretary a fee of $10,000 
     due on the date on which the exporter first submits that 
     registration to the Secretary under subsection (b).
       ``(2) Inspection fee.--A registration condition is that the 
     exporter involved pays a fee to the Secretary in accordance 
     with this subsection. Such fee shall be paid not later than 
     October 1 and April 1 of each fiscal year in the amount 
     provided for under paragraph (3).
       ``(3) Amount of inspection fee.--
       ``(A) Aggregate total of fees.--Not later than 30 days 
     before the start of each fiscal year, the Secretary, in 
     consultation with the Secretary of Homeland Security and the 
     Secretary of the Treasury, shall establish an aggregate total 
     of fees to be collected under paragraph (2) for exporters for 
     that fiscal year that is sufficient, and not more than 
     necessary, to pay the costs for that fiscal year of 
     administering this section with respect to registered 
     exporters, including the costs associated with--
       ``(i) inspecting the facilities of registered exporters, 
     and of other entities in the chain of custody of a qualifying 
     drug as necessary, under subsection (d)(3);
       ``(ii) developing, implementing, and operating under such 
     subsection a system to screen marks on shipments of 
     qualifying drugs under subsection (a) that indicate 
     compliance with all registration conditions, when such 
     shipments are offered for import into the United States; and
       ``(iii) screening such markings, and inspecting such 
     shipments as necessary, when offered for import into the 
     United States to determine if such a shipment should be 
     refused admission under subsection (g)(5).
       ``(B) Limitation.--Subject to subparagraph (C), the 
     aggregate total of fees collected under paragraph (2) for a 
     fiscal year shall not exceed 2.5 percent of the total price 
     of qualifying drugs imported during that fiscal year into the 
     United States by registered exporters under subsection (a).
       ``(C) Total price of drugs.--
       ``(i) Estimate.--For the purposes of complying with the 
     limitation described in subparagraph (B) when establishing 
     under subparagraph (A) the aggregate total of fees to be 
     collected under paragraph (2) for a fiscal year, the 
     Secretary shall estimate the total price of qualifying drugs 
     imported into the United States by registered exporters 
     during that fiscal year by adding the total price of 
     qualifying drugs exported by each registered exporter during 
     the 6-month period from January 1 through June 30 of the 
     previous fiscal year, as reported to the Secretary by each 
     registered exporter under subsection (b)(1)(I)(iv).
       ``(ii) Calculation.--Not later than March 1 of the fiscal 
     year that follows the fiscal year for which the estimate 
     under clause (i) is made, the Secretary shall calculate the 
     total price of qualifying drugs imported into the United 
     States by registered exporters during that fiscal year by 
     adding the total price of qualifying drugs exported by each 
     registered exporter during that fiscal year, as reported to 
     the Secretary by each registered exporter under subsection 
     (b)(1)(I)(iv).
       ``(iii) Adjustment.--If the total price of qualifying drugs 
     imported into the United States by registered exporters 
     during a fiscal year as calculated under clause (ii) is less 
     than the aggregate total of fees collected under paragraph 
     (2) for that fiscal year, the Secretary shall provide for a 
     pro-rata reduction in the fee due from each registered 
     exporter on April 1 of the subsequent fiscal year so that the 
     limitation described in subparagraph (B) is observed.
       ``(D) Individual exporter fee.--Subject to the limitation 
     described in subparagraph (B), the fee under paragraph (2) to 
     be paid on October 1 and April 1 by an exporter shall be an 
     amount that is proportional to a reasonable estimate by the 
     Secretary of the semiannual share of the exporter of the 
     volume of qualifying drugs exported by exporters under 
     subsection (a).
       ``(4) Use of fees.--
       ``(A) In general.--Fees collected by the Secretary under 
     paragraphs (1) and (2) shall be credited to the appropriation 
     account for salaries and expenses of the Food and Drug 
     Administration until expended (without fiscal year 
     limitation), and the Secretary may, in consultation with the 
     Secretary of Homeland Security and the Secretary of the 
     Treasury, transfer some proportion of such fees to the 
     appropriation account for salaries and expenses of the Bureau 
     of Customs and Border Protection until expended (without 
     fiscal year limitation).
       ``(B) Availability.--Fees collected by the Secretary under 
     paragraphs (1) and (2) shall be made available to the Food 
     and Drug Administration.
       ``(C) Sole purpose.--Fees collected by the Secretary under 
     paragraphs (1) and (2) are only available to the Secretary 
     and, if transferred, to the Secretary of Homeland Security, 
     and are for the sole purpose of paying the costs referred to 
     in paragraph (3)(A).
       ``(5) Collection of fees.--In any case where the Secretary 
     does not receive payment of a fee assessed under paragraph 
     (1) or (2) within 30 days after it is due, such fee shall be 
     treated as a claim of the United States Government subject to 
     subchapter II of chapter 37 of title 31, United States Code.
       ``(g) Compliance With Section 801(a).--
       ``(1) In general.--A registration condition is that each 
     qualifying drug exported under subsection (a) by the 
     registered exporter involved or imported under subsection (a) 
     by the registered importer involved is in compliance with the 
     standards referred to in section 801(a) regarding admission 
     of the drug into the United States, subject to paragraphs 
     (2), (3), and (4).
       ``(2) Section 505; approval status.--
       ``(A) In general.--A qualifying drug that is imported or 
     offered for import under subsection (a) shall comply with the 
     conditions established in the approved application under 
     section 505(b) for the U.S. label drug as described under 
     this subsection.
       ``(B) Notice by manufacturer; general provisions.--
       ``(i) In general.--The person that manufactures a 
     qualifying drug that is, or will be, introduced for 
     commercial distribution in a permitted country shall in 
     accordance with this paragraph submit to the Secretary a 
     notice that--

       ``(I) includes each difference in the qualifying drug from 
     a condition established in the approved application for the 
     U.S. label drug beyond--

       ``(aa) the variations provided for in the application; and
       ``(bb) any difference in labeling (except ingredient 
     labeling); or

       ``(II) states that there is no difference in the qualifying 
     drug from a condition established in the approved application 
     for the U.S. label drug beyond--

       ``(aa) the variations provided for in the application; and
       ``(bb) any difference in labeling (except ingredient 
     labeling).
       ``(ii) Information in notice.--A notice under clause (i)(I) 
     shall include the information that the Secretary may require 
     under section 506A, any additional information the Secretary 
     may require (which may include data on bioequivalence if such 
     data are not required under section 506A), and, with respect 
     to the permitted country that approved the qualifying drug 
     for commercial distribution, or with respect to which such 
     approval is sought, include the following:

[[Page 4929]]

       ``(I) The date on which the qualifying drug with such 
     difference was, or will be, introduced for commercial 
     distribution in the permitted country.
       ``(II) Information demonstrating that the person submitting 
     the notice has also notified the government of the permitted 
     country in writing that the person is submitting to the 
     Secretary a notice under clause (i)(I), which notice 
     describes the difference in the qualifying drug from a 
     condition established in the approved application for the 
     U.S. label drug.
       ``(III) The information that the person submitted or will 
     submit to the government of the permitted country for 
     purposes of obtaining approval for commercial distribution of 
     the drug in the country which, if in a language other than 
     English, shall be accompanied by an English translation 
     verified to be complete and accurate, with the name, address, 
     and a brief statement of the qualifications of the person 
     that made the translation.

       ``(iii) Certifications.--The chief executive officer and 
     the chief medical officer of the manufacturer involved shall 
     each certify in the notice under clause (i) that--

       ``(I) the information provided in the notice is complete 
     and true; and
       ``(II) a copy of the notice has been provided to the 
     Federal Trade Commission and to the State attorneys general.

       ``(iv) Fee.--

       ``(I) In general.--If a notice submitted under clause (i) 
     includes a difference that would, under section 506A, require 
     the submission of a supplemental application if made as a 
     change to the U.S. label drug, the person that submits the 
     notice shall pay to the Secretary a fee in the same amount as 
     would apply if the person were paying a fee pursuant to 
     section 736(a)(1)(A)(ii). Fees collected by the Secretary 
     under the preceding sentence are available only to the 
     Secretary and are for the sole purpose of paying the costs of 
     reviewing notices submitted under clause (i).
       ``(II) Fee amount for certain years.--If no fee amount is 
     in effect under section 736(a)(1)(A)(ii) for a fiscal year, 
     then the amount paid by a person under subclause (I) shall--

       ``(aa) for the first fiscal year in which no fee amount 
     under such section in effect, be equal to the fee amount 
     under section 736(a)(1)(A)(ii) for the most recent fiscal 
     year for which such section was in effect, adjusted in 
     accordance with section 736(c); and
       ``(bb) for each subsequent fiscal year in which no fee 
     amount under such section is effect, be equal to the 
     applicable fee amount for the previous fiscal year, adjusted 
     in accordance with section 736(c).
       ``(v) Timing of submission of notices.--

       ``(I) Prior approval notices.--A notice under clause (i) to 
     which subparagraph (C) applies shall be submitted to the 
     Secretary not later than 120 days before the qualifying drug 
     with the difference is introduced for commercial distribution 
     in a permitted country, unless the country requires that 
     distribution of the qualifying drug with the difference begin 
     less than 120 days after the country requires the difference.
       ``(II) Other approval notices.--A notice under clause (i) 
     to which subparagraph (D) applies shall be submitted to the 
     Secretary not later than the day on which the qualifying drug 
     with the difference is introduced for commercial distribution 
     in a permitted country.
       ``(III) Other notices.--A notice under clause (i) to which 
     subparagraph (E) applies shall be submitted to the Secretary 
     on the date that the qualifying drug is first introduced for 
     commercial distribution in a permitted country and annually 
     thereafter.

       ``(vi) Review by secretary.--

       ``(I) In general.--In this paragraph, the difference in a 
     qualifying drug that is submitted in a notice under clause 
     (i) from the U.S. label drug shall be treated by the 
     Secretary as if it were a manufacturing change to the U.S. 
     label drug under section 506A.
       ``(II) Standard of review.--Except as provided in subclause 
     (III), the Secretary shall review and approve or disapprove 
     the difference in a notice submitted under clause (i), if 
     required under section 506A, using the safe and effective 
     standard for approving or disapproving a manufacturing change 
     under section 506A.
       ``(III) Bioequivalence.--If the Secretary would approve the 
     difference in a notice submitted under clause (i) using the 
     safe and effective standard under section 506A and if the 
     Secretary determines that the qualifying drug is not 
     bioequivalent to the U.S. label drug, the Secretary shall--

       ``(aa) include in the labeling provided under paragraph (3) 
     a prominent advisory that the qualifying drug is safe and 
     effective but is not bioequivalent to the U.S. label drug if 
     the Secretary determines that such an advisory is necessary 
     for health care practitioners and patients to use the 
     qualifying drug safely and effectively; or
       ``(bb) decline to approve the difference if the Secretary 
     determines that the availability of both the qualifying drug 
     and the U.S. label drug would pose a threat to the public 
     health.

       ``(IV) Review by the secretary.--The Secretary shall review 
     and approve or disapprove the difference in a notice 
     submitted under clause (i), if required under section 506A, 
     not later than 120 days after the date on which the notice is 
     submitted.
       ``(V) Establishment inspection.--If review of such 
     difference would require an inspection of the establishment 
     in which the qualifying drug is manufactured--

       ``(aa) such inspection by the Secretary shall be 
     authorized; and
       ``(bb) the Secretary may rely on a satisfactory report of a 
     good manufacturing practice inspection of the establishment 
     from a permitted country whose regulatory system the 
     Secretary recognizes as equivalent under a mutual recognition 
     agreement, as provided under section 510(i)(3), section 803, 
     or part 26 of title 21, Code of Federal Regulations (or any 
     corresponding successor rule or regulation).
       ``(vii) Publication of information on notices.--

       ``(I) In general.--Through the Internet website of the Food 
     and Drug Administration and a toll-free telephone number, the 
     Secretary shall readily make available to the public a list 
     of notices submitted under clause (i).
       ``(II) Contents.--The list under subclause (I) shall 
     include the date on which a notice is submitted and whether--

       ``(aa) a notice is under review;
       ``(bb) the Secretary has ordered that importation of the 
     qualifying drug from a permitted country cease; or
       ``(cc) the importation of the drug is permitted under 
     subsection (a).

       ``(III) Update.--The Secretary shall promptly update the 
     Internet website with any changes to the list.

       ``(C) Notice; drug difference requiring prior approval.--In 
     the case of a notice under subparagraph (B)(i) that includes 
     a difference that would, under subsection (c) or (d)(3)(B)(i) 
     of section 506A, require the approval of a supplemental 
     application before the difference could be made to the U.S. 
     label drug the following shall occur:
       ``(i) Promptly after the notice is submitted, the Secretary 
     shall notify registered exporters, registered importers, the 
     Federal Trade Commission, and the State attorneys general 
     that the notice has been submitted with respect to the 
     qualifying drug involved.
       ``(ii) If the Secretary has not made a determination 
     whether such a supplemental application regarding the U.S. 
     label drug would be approved or disapproved by the date on 
     which the qualifying drug involved is to be introduced for 
     commercial distribution in a permitted country, the Secretary 
     shall--

       ``(I) order that the importation of the qualifying drug 
     involved from the permitted country not begin until the 
     Secretary completes review of the notice; and
       ``(II) promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of the order.

       ``(iii) If the Secretary determines that such a 
     supplemental application regarding the U.S. label drug would 
     not be approved, the Secretary shall--

       ``(I) order that the importation of the qualifying drug 
     involved from the permitted country cease, or provide that an 
     order under clause (ii), if any, remains in effect;
       ``(II) notify the permitted country that approved the 
     qualifying drug for commercial distribution of the 
     determination; and
       ``(III) promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of the determination.

       ``(iv) If the Secretary determines that such a supplemental 
     application regarding the U.S. label drug would be approved, 
     the Secretary shall--

       ``(I) vacate the order under clause (ii), if any;
       ``(II) consider the difference to be a variation provided 
     for in the approved application for the U.S. label drug;
       ``(III) permit importation of the qualifying drug under 
     subsection (a); and
       ``(IV) promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of the determination.

       ``(D) Notice; drug difference not requiring prior 
     approval.--In the case of a notice under subparagraph (B)(i) 
     that includes a difference that would, under section 
     506A(d)(3)(B)(ii), not require the approval of a supplemental 
     application before the difference could be made to the U.S. 
     label drug the following shall occur:
       ``(i) During the period in which the notice is being 
     reviewed by the Secretary, the authority under this 
     subsection to import the qualifying drug involved continues 
     in effect.
       ``(ii) If the Secretary determines that such a supplemental 
     application regarding the U.S. label drug would not be 
     approved, the Secretary shall--

       ``(I) order that the importation of the qualifying drug 
     involved from the permitted country cease;
       ``(II) notify the permitted country that approved the 
     qualifying drug for commercial distribution of the 
     determination; and
       ``(III) promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of the determination.

       ``(iii) If the Secretary determines that such a 
     supplemental application regarding the

[[Page 4930]]

     U.S. label drug would be approved, the difference shall be 
     considered to be a variation provided for in the approved 
     application for the U.S. label drug.
       ``(E) Notice; drug difference not requiring approval; no 
     difference.--In the case of a notice under subparagraph 
     (B)(i) that includes a difference for which, under section 
     506A(d)(1)(A), a supplemental application would not be 
     required for the difference to be made to the U.S. label 
     drug, or that states that there is no difference, the 
     Secretary--
       ``(i) shall consider such difference to be a variation 
     provided for in the approved application for the U.S. label 
     drug;
       ``(ii) may not order that the importation of the qualifying 
     drug involved cease; and
       ``(iii) shall promptly notify registered exporters and 
     registered importers.
       ``(F) Differences in active ingredient, route of 
     administration, dosage form, or strength.--
       ``(i) In general.--A person who manufactures a drug 
     approved under section 505(b) shall submit an application 
     under section 505(b) for approval of another drug that is 
     manufactured for distribution in a permitted country by or 
     for the person that manufactures the drug approved under 
     section 505(b) if--

       ``(I) there is no qualifying drug in commercial 
     distribution in permitted countries whose combined population 
     represents at least 50 percent of the total population of all 
     permitted countries with the same active ingredient or 
     ingredients, route of administration, dosage form, and 
     strength as the drug approved under section 505(b); and
       ``(II) each active ingredient of the other drug is related 
     to an active ingredient of the drug approved under section 
     505(b), as defined in clause (v).

       ``(ii) Application under section 505(b).--The application 
     under section 505(b) required under clause (i) shall--

       ``(I) request approval of the other drug for the indication 
     or indications for which the drug approved under section 
     505(b) is labeled;
       ``(II) include the information that the person submitted to 
     the government of the permitted country for purposes of 
     obtaining approval for commercial distribution of the other 
     drug in that country, which if in a language other than 
     English, shall be accompanied by an English translation 
     verified to be complete and accurate, with the name, address, 
     and a brief statement of the qualifications of the person 
     that made the translation;
       ``(III) include a right of reference to the application for 
     the drug approved under section 505(b); and
       ``(IV) include such additional information as the Secretary 
     may require.

       ``(iii) Timing of submission of application.--An 
     application under section 505(b) required under clause (i) 
     shall be submitted to the Secretary not later than the day on 
     which the information referred to in clause (ii)(II) is 
     submitted to the government of the permitted country.
       ``(iv) Notice of decision on application.--The Secretary 
     shall promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of a determination to approve or to 
     disapprove an application under section 505(b) required under 
     clause (i).
       ``(v) Related active ingredients.--For purposes of clause 
     (i)(II), 2 active ingredients are related if they are--

       ``(I) the same; or
       ``(II) different salts, esters, or complexes of the same 
     moiety.

       ``(3) Section 502; labeling.--
       ``(A) Importation by registered importer.--
       ``(i) In general.--In the case of a qualifying drug that is 
     imported or offered for import by a registered importer, such 
     drug shall be considered to be in compliance with section 502 
     and the labeling requirements under the approved application 
     for the U.S. label drug if the qualifying drug bears--

       ``(I) a copy of the labeling approved for the U.S. label 
     drug under section 505, without regard to whether the copy 
     bears any trademark involved;
       ``(II) the name of the manufacturer and location of the 
     manufacturer;
       ``(III) the lot number assigned by the manufacturer;
       ``(IV) the name, location, and registration number of the 
     importer; and
       ``(V) the National Drug Code number assigned to the 
     qualifying drug by the Secretary.

       ``(ii) Request for copy of the labeling.--The Secretary 
     shall provide such copy to the registered importer involved, 
     upon request of the importer.
       ``(iii) Requested labeling.--The labeling provided by the 
     Secretary under clause (ii) shall--

       ``(I) include the established name, as defined in section 
     502(e)(3), for each active ingredient in the qualifying drug;
       ``(II) not include the proprietary name of the U.S. label 
     drug or any active ingredient thereof;
       ``(III) if required under paragraph (2)(B)(vi)(III), a 
     prominent advisory that the qualifying drug is safe and 
     effective but not bioequivalent to the U.S. label drug; and
       ``(IV) if the inactive ingredients of the qualifying drug 
     are different from the inactive ingredients for the U.S. 
     label drug, include--

       ``(aa) a prominent notice that the ingredients of the 
     qualifying drug differ from the ingredients of the U.S. label 
     drug and that the qualifying drug must be dispensed with an 
     advisory to people with allergies about this difference and a 
     list of ingredients; and
       ``(bb) a list of the ingredients of the qualifying drug as 
     would be required under section 502(e).
       ``(B) Importation by individual.--
       ``(i) In general.--In the case of a qualifying drug that is 
     imported or offered for import by a registered exporter to an 
     individual, such drug shall be considered to be in compliance 
     with section 502 and the labeling requirements under the 
     approved application for the U.S. label drug if the packaging 
     and labeling of the qualifying drug complies with all 
     applicable regulations promulgated under sections 3 and 4 of 
     the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 
     et seq.) and the labeling of the qualifying drug includes--

       ``(I) directions for use by the consumer;
       ``(II) the lot number assigned by the manufacturer;
       ``(III) the name and registration number of the exporter;
       ``(IV) if required under paragraph (2)(B)(vi)(III), a 
     prominent advisory that the drug is safe and effective but 
     not bioequivalent to the U.S. label drug;
       ``(V) if the inactive ingredients of the drug are different 
     from the inactive ingredients for the U.S. label drug--

       ``(aa) a prominent advisory that persons with an allergy 
     should check the ingredient list of the drug because the 
     ingredients of the drug differ from the ingredients of the 
     U.S. label drug; and
       ``(bb) a list of the ingredients of the drug as would be 
     required under section 502(e); and

       ``(VI) a copy of any special labeling that would be 
     required by the Secretary had the U.S. label drug been 
     dispensed by a pharmacist in the United States, without 
     regard to whether the special labeling bears any trademark 
     involved.

       ``(ii) Packaging.--A qualifying drug offered for import to 
     an individual by an exporter under this section that is 
     packaged in a unit-of-use container (as those items are 
     defined in the United States Pharmacopeia and National 
     Formulary) shall not be repackaged, provided that--

       ``(I) the packaging complies with all applicable 
     regulations under sections 3 and 4 of the Poison Prevention 
     Packaging Act of 1970 (15 U.S.C. 1471 et seq.); or
       ``(II) the consumer consents to waive the requirements of 
     such Act, after being informed that the packaging does not 
     comply with such Act and that the exporter will provide the 
     drug in packaging that is compliant at no additional cost.

       ``(iii) Request for copy of special labeling and ingredient 
     list.--The Secretary shall provide to the registered exporter 
     involved a copy of the special labeling, the advisory, and 
     the ingredient list described under clause (i), upon request 
     of the exporter.
       ``(iv) Requested labeling and ingredient list.--The 
     labeling and ingredient list provided by the Secretary under 
     clause (iii) shall--

       ``(I) include the established name, as defined in section 
     502(e)(3), for each active ingredient in the drug; and
       ``(II) not include the proprietary name of the U.S. label 
     drug or any active ingredient thereof.

       ``(4) Section 501; adulteration.--A qualifying drug that is 
     imported or offered for import under subsection (a) shall be 
     considered to be in compliance with section 501 if the drug 
     is in compliance with subsection (c).
       ``(5) Standards for refusing admission.--A drug exported 
     under subsection (a) from a registered exporter or imported 
     by a registered importer may be refused admission into the 
     United States if 1 or more of the following applies:
       ``(A) The drug is not a qualifying drug.
       ``(B) A notice for the drug required under paragraph (2)(B) 
     has not been submitted to the Secretary.
       ``(C) The Secretary has ordered that importation of the 
     drug from the permitted country cease under subparagraph (C) 
     or (D) of paragraph (2).
       ``(D) The drug does not comply with paragraph (3) or (4).
       ``(E) The shipping container appears damaged in a way that 
     may affect the strength, quality, or purity of the drug.
       ``(F) The Secretary becomes aware that--
       ``(i) the drug may be counterfeit;
       ``(ii) the drug may have been prepared, packed, or held 
     under insanitary conditions; or
       ``(iii) the methods used in, or the facilities or controls 
     used for, the manufacturing, processing, packing, or holding 
     of the drug do not conform to good manufacturing practice.
       ``(G) The Secretary has obtained an injunction under 
     section 302 that prohibits the distribution of the drug in 
     interstate commerce.
       ``(H) The Secretary has under section 505(e) withdrawn 
     approval of the drug.
       ``(I) The manufacturer of the drug has instituted a recall 
     of the drug.

[[Page 4931]]

       ``(J) If the drug is imported or offered for import by a 
     registered importer without submission of a notice in 
     accordance with subsection (d)(4).
       ``(K) If the drug is imported or offered for import from a 
     registered exporter to an individual and 1 or more of the 
     following applies:
       ``(i) The shipping container for such drug does not bear 
     the markings required under subsection (d)(2).
       ``(ii) The markings on the shipping container appear to be 
     counterfeit.
       ``(iii) The shipping container or markings appear to have 
     been tampered with.
       ``(h) Exporter Licensure in Permitted Country.--A 
     registration condition is that the exporter involved agrees 
     that a qualifying drug will be exported to an individual only 
     if the Secretary has verified that--
       ``(1) the exporter is authorized under the law of the 
     permitted country in which the exporter is located to 
     dispense prescription drugs; and
       ``(2) the exporter employs persons that are licensed under 
     the law of the permitted country in which the exporter is 
     located to dispense prescription drugs in sufficient number 
     to dispense safely the drugs exported by the exporter to 
     individuals, and the exporter assigns to those persons 
     responsibility for dispensing such drugs to individuals.
       ``(i) Individuals; Conditions for Importation.--
       ``(1) In general.--For purposes of subsection (a)(2)(B), 
     the importation of a qualifying drug by an individual is in 
     accordance with this subsection if the following conditions 
     are met:
       ``(A) The drug is accompanied by a copy of a prescription 
     for the drug, which prescription--
       ``(i) is valid under applicable Federal and State laws; and
       ``(ii) was issued by a practitioner who, under the law of a 
     State of which the individual is a resident, or in which the 
     individual receives care from the practitioner who issues the 
     prescription, is authorized to administer prescription drugs.
       ``(B) The drug is accompanied by a copy of the 
     documentation that was required under the law or regulations 
     of the permitted country in which the exporter is located, as 
     a condition of dispensing the drug to the individual.
       ``(C) The copies referred to in subparagraphs (A)(i) and 
     (B) are marked in a manner sufficient--
       ``(i) to indicate that the prescription, and the equivalent 
     document in the permitted country in which the exporter is 
     located, have been filled; and
       ``(ii) to prevent a duplicative filling by another 
     pharmacist.
       ``(D) The individual has provided to the registered 
     exporter a complete list of all drugs used by the individual 
     for review by the individuals who dispense the drug.
       ``(E) The quantity of the drug does not exceed a 90-day 
     supply.
       ``(F) The drug is not an ineligible subpart H drug. For 
     purposes of this section, a prescription drug is an 
     `ineligible subpart H drug' if the drug was approved by the 
     Secretary under subpart H of part 314 of title 21, Code of 
     Federal Regulations (relating to accelerated approval), with 
     restrictions under section 520 of such part to assure safe 
     use, and the Secretary has published in the Federal Register 
     a notice that the Secretary has determined that good cause 
     exists to prohibit the drug from being imported pursuant to 
     this subsection.
       ``(2) Notice regarding drug refused admission.--If a 
     registered exporter ships a drug to an individual pursuant to 
     subsection (a)(2)(B) and the drug is refused admission to the 
     United States, a written notice shall be sent to the 
     individual and to the exporter that informs the individual 
     and the exporter of such refusal and the reason for the 
     refusal.
       ``(j) Maintenance of Records and Samples.--
       ``(1) In general.--A registration condition is that the 
     importer or exporter involved shall--
       ``(A) maintain records required under this section for not 
     less than 2 years; and
       ``(B) maintain samples of each lot of a qualifying drug 
     required under this section for not more than 2 years.
       ``(2) Place of record maintenance.--The records described 
     under paragraph (1) shall be maintained--
       ``(A) in the case of an importer, at the place of business 
     of the importer at which the importer initially receives the 
     qualifying drug after importation; or
       ``(B) in the case of an exporter, at the facility from 
     which the exporter ships the qualifying drug to the United 
     States.
       ``(k) Drug Recalls.--
       ``(1) Manufacturers.--A person that manufactures a 
     qualifying drug imported from a permitted country under this 
     section shall promptly inform the Secretary--
       ``(A) if the drug is recalled or withdrawn from the market 
     in a permitted country;
       ``(B) how the drug may be identified, including lot number; 
     and
       ``(C) the reason for the recall or withdrawal.
       ``(2) Secretary.--With respect to each permitted country, 
     the Secretary shall--
       ``(A) enter into an agreement with the government of the 
     country to receive information about recalls and withdrawals 
     of qualifying drugs in the country; or
       ``(B) monitor recalls and withdrawals of qualifying drugs 
     in the country using any information that is available to the 
     public in any media.
       ``(3) Notice.--The Secretary may notify, as appropriate, 
     registered exporters, registered importers, wholesalers, 
     pharmacies, or the public of a recall or withdrawal of a 
     qualifying drug in a permitted country.
       ``(l) Drug Labeling and Packaging.--
       ``(1) In general.--When a qualifying drug that is imported 
     into the United States by an importer under subsection (a) is 
     dispensed by a pharmacist to an individual, the pharmacist 
     shall provide that the packaging and labeling of the drug 
     complies with all applicable regulations promulgated under 
     sections 3 and 4 of the Poison Prevention Packaging Act of 
     1970 (15 U.S.C. 1471 et seq.) and shall include with any 
     other labeling provided to the individual the following:
       ``(A) The lot number assigned by the manufacturer.
       ``(B) The name and registration number of the importer.
       ``(C) If required under paragraph (2)(B)(vi)(III) of 
     subsection (g), a prominent advisory that the drug is safe 
     and effective but not bioequivalent to the U.S. label drug.
       ``(D) If the inactive ingredients of the drug are different 
     from the inactive ingredients for the U.S. label drug--
       ``(i) a prominent advisory that persons with allergies 
     should check the ingredient list of the drug because the 
     ingredients of the drug differ from the ingredients of the 
     U.S. label drug; and
       ``(ii) a list of the ingredients of the drug as would be 
     required under section 502(e).
       ``(2) Packaging.--A qualifying drug that is packaged in a 
     unit-of-use container (as those terms are defined in the 
     United States Pharmacopeia and National Formulary) shall not 
     be repackaged, provided that--
       ``(A) the packaging complies with all applicable 
     regulations under sections 3 and 4 of the Poison Prevention 
     Packaging Act of 1970 (15 U.S.C. 1471 et seq.); or
       ``(B) the consumer consents to waive the requirements of 
     such Act, after being informed that the packaging does not 
     comply with such Act and that the pharmacist will provide the 
     drug in packaging that is compliant at no additional cost.
       ``(m) Charitable Contributions.--Notwithstanding any other 
     provision of this section, this section does not authorize 
     the importation into the United States of a qualifying drug 
     donated or otherwise supplied for free or at nominal cost by 
     the manufacturer of the drug to a charitable or humanitarian 
     organization, including the United Nations and affiliates, or 
     to a government of a foreign country.
       ``(n) Unfair and Discriminatory Acts and Practices.--
       ``(1) In general.--It is unlawful for a manufacturer, 
     directly or indirectly (including by being a party to a 
     licensing agreement or other agreement), to--
       ``(A) discriminate by charging a higher price for a 
     prescription drug sold to a registered exporter or other 
     person in a permitted country that exports a qualifying drug 
     to the United States under this section than the price that 
     is charged, inclusive of rebates or other incentives to the 
     permitted country or other person, to another person that is 
     in the same country and that does not export a qualifying 
     drug into the United States under this section;
       ``(B) discriminate by charging a higher price for a 
     prescription drug sold to a registered importer or other 
     person that distributes, sells, or uses a qualifying 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 qualifying drug under this section, or 
     that does not distribute, sell, or use such a drug;
       ``(C) discriminate by denying, restricting, or delaying 
     supplies of a prescription drug to a registered exporter or 
     other person in a permitted country that exports a qualifying 
     drug to the United States under this section or to a 
     registered importer or other person that distributes, sells, 
     or uses a qualifying drug imported into the United States 
     under this section;
       ``(D) discriminate by publicly, privately, or otherwise 
     refusing to do business with a registered exporter or other 
     person in a permitted country that exports a qualifying drug 
     to the United States under this section or with a registered 
     importer or other person that distributes, sells, or uses a 
     qualifying drug imported into the United States under this 
     section;
       ``(E) knowingly fail to submit a notice under subsection 
     (g)(2)(B)(i), knowingly fail to submit such a notice on or 
     before the date specified in subsection (g)(2)(B)(v) or as 
     otherwise required under paragraphs (3), (4), and (5) of 
     section 3004(e) of the Pharmaceutical Market Access and Drug 
     Safety Act of 2010, knowingly submit such a notice that makes 
     a materially false, fictitious, or fraudulent statement, or 
     knowingly fail to provide promptly any information requested 
     by the Secretary to review such a notice;
       ``(F) knowingly fail to submit an application required 
     under subsection (g)(2)(F), knowingly fail to submit such an 
     application on or before the date specified in subsection

[[Page 4932]]

     (g)(2)(F)(iii), knowingly submit such an application that 
     makes a materially false, fictitious, or fraudulent 
     statement, or knowingly fail to provide promptly any 
     information requested by the Secretary to review such an 
     application;
       ``(G) 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;
       ``(H) refuse to allow an inspection authorized under this 
     section of an establishment that manufactures a qualifying 
     drug that is, or will be, introduced for commercial 
     distribution in a permitted country;
       ``(I) fail to conform to the methods used in, or the 
     facilities used for, the manufacturing, processing, packing, 
     or holding of a qualifying drug that is, or will be, 
     introduced for commercial distribution in a permitted country 
     to good manufacturing practice under this Act;
       ``(J) become a party to a licensing agreement or other 
     agreement related to a qualifying drug that fails to provide 
     for compliance with all requirements of this section with 
     respect to such drug;
       ``(K) enter into a contract that restricts, prohibits, or 
     delays the importation of a qualifying drug under this 
     section;
       ``(L) engage in any other action to restrict, prohibit, or 
     delay the importation of a qualifying drug under this 
     section; or
       ``(M) engage in any other action that the Federal Trade 
     Commission determines to discriminate against a person that 
     engages or attempts to engage in the importation of a 
     qualifying drug under this section.
       ``(2) Referral of potential violations.--The Secretary 
     shall promptly refer to the Federal Trade Commission each 
     potential violation of subparagraph (E), (F), (G), (H), or 
     (I) of paragraph (1) that becomes known to the Secretary.
       ``(3) Affirmative defense.--
       ``(A) Discrimination.--It shall be an affirmative defense 
     to a charge that a manufacturer has discriminated under 
     subparagraph (A), (B), (C), (D), or (M) of paragraph (1) that 
     the higher price charged for a prescription drug sold to a 
     person, the denial, restriction, or delay of supplies of a 
     prescription drug to a person, the refusal to do business 
     with a person, or other discriminatory activity against a 
     person, is not based, in whole or in part, on--
       ``(i) the person exporting or importing a qualifying drug 
     into the United States under this section; or
       ``(ii) the person distributing, selling, or using a 
     qualifying drug imported into the United States under this 
     section.
       ``(B) Drug differences.--It shall be an affirmative defense 
     to a charge that a manufacturer has caused there to be a 
     difference described in subparagraph (G) of paragraph (1) 
     that--
       ``(i) the difference was required by the country in which 
     the drug is distributed;
       ``(ii) the Secretary has determined that the difference was 
     necessary to improve the safety or effectiveness of the drug;
       ``(iii) the person manufacturing the drug for distribution 
     in the United States has given notice to the Secretary under 
     subsection (g)(2)(B)(i) that the drug for distribution in the 
     United States is not different from a drug for distribution 
     in permitted countries whose combined population represents 
     at least 50 percent of the total population of all permitted 
     countries; or
       ``(iv) the difference was not caused, in whole or in part, 
     for the purpose of restricting importation of the drug into 
     the United States under this section.
       ``(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 
     (15 U.S.C. 57a(a)(1)(B)).
       ``(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 (15 U.S.C. 41 et seq.) were 
     incorporated into and made a part of this section; and
       ``(ii) may seek monetary relief threefold the damages 
     sustained, in addition to any other remedy available to the 
     Federal Trade Commission under the Federal Trade Commission 
     Act (15 U.S.C. 41 et seq.).
       ``(6) Actions by states.--
       ``(A) In general.--
       ``(i) Civil actions.--In any case in which the attorney 
     general of a State has reason to believe that an interest of 
     the residents of that State have been adversely affected by 
     any manufacturer that violates paragraph (1), 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 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 Federal Trade Commission shall have the right to 
     intervene in the action that is the subject of the notice.
       ``(ii) Effect of intervention.--If the Federal Trade 
     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.--In any case in which an 
     action is instituted by or on behalf of the Federal Trade 
     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.
       ``(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) 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.
       ``(H) 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

[[Page 4933]]

     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) Prohibited Acts.--The Federal Food, Drug, and Cosmetic 
     Act is amended--
       (1) in section 301 (21 U.S.C. 331), by striking paragraph 
     (aa) and inserting the following:
       ``(aa)(1) The sale or trade by a pharmacist, or by a 
     business organization of which the pharmacist is a part, of a 
     qualifying drug that under section 804(a)(2)(A) was imported 
     by the pharmacist, other than--
       ``(A) a sale at retail made pursuant to dispensing the drug 
     to a customer of the pharmacist or organization; or
       ``(B) a sale or trade of the drug to a pharmacy or a 
     wholesaler registered to import drugs under section 804.
       ``(2) The sale or trade by an individual of a qualifying 
     drug that under section 804(a)(2)(B) was imported by the 
     individual.
       ``(3) The making of a materially false, fictitious, or 
     fraudulent statement or representation, or a material 
     omission, in a notice under clause (i) of section 
     804(g)(2)(B) or in an application required under section 
     804(g)(2)(F), or the failure to submit such a notice or 
     application.
       ``(4) The importation of a drug in violation of a 
     registration condition or other requirement under section 
     804, the falsification of any record required to be 
     maintained, or provided to the Secretary, under such section, 
     or the violation of any registration condition or other 
     requirement under such section.''; and
       (2) in section 303(a) (21 U.S.C. 333(a)), by striking 
     paragraph (6) and inserting the following:
       ``(6) Notwithstanding subsection (a), any person that 
     knowingly violates section 301(i) (2) or (3) or section 
     301(aa)(4) shall be imprisoned not more than 10 years, or 
     fined in accordance with title 18, United States Code, or 
     both.''.
       (c) Amendment of Certain Provisions.--
       (1) In general.--Section 801 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 381) is amended by striking 
     subsection (g) and inserting the following:
       ``(g) With respect to a prescription drug that is imported 
     or offered for import into the United States by an individual 
     who is not in the business of such importation, that is not 
     shipped by a registered exporter under section 804, and that 
     is refused admission under subsection (a), the Secretary 
     shall notify the individual that--
       ``(1) the drug has been refused admission because the drug 
     was not a lawful import under section 804;
       ``(2) the drug is not otherwise subject to a waiver of the 
     requirements of subsection (a);
       ``(3) the individual may under section 804 lawfully import 
     certain prescription drugs from exporters registered with the 
     Secretary under section 804; and
       ``(4) the individual can find information about such 
     importation, including a list of registered exporters, on the 
     Internet website of the Food and Drug Administration or 
     through a toll-free telephone number required under section 
     804.''.
       (2) Establishment registration.--Section 510(i) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is 
     amended in paragraph (1) by inserting after ``import into the 
     United States'' the following: ``, including a drug that is, 
     or may be, imported or offered for import into the United 
     States under section 804,''.
       (3) Effective date.--The amendments made by this subsection 
     shall take effect on the date that is 90 days after the date 
     of enactment of this Act.
       (d) Exhaustion.--
       (1) In general.--Section 271 of title 35, United States 
     Code, is amended--
       (A) by redesignating subsections (h) and (i) as (i) and 
     (j), respectively; and
       (B) 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 that was first sold 
     abroad by or under authority of the owner or licensee of such 
     patent.''.
       (2) Rule of construction.--Nothing in the amendment made by 
     paragraph (1) shall be construed to affect the ability of a 
     patent owner or licensee to enforce their patent, subject to 
     such amendment.
       (e) Effect of Section 804.--
       (1) In general.--Section 804 of the Federal Food, Drug, and 
     Cosmetic Act, as added by subsection (a), shall permit the 
     importation of qualifying drugs (as defined in such section 
     804) into the United States without regard to the status of 
     the issuance of implementing regulations--
       (A) from exporters registered under such section 804 on the 
     date that is 90 days after the date of enactment of this Act; 
     and
       (B) from permitted countries, as defined in such section 
     804, by importers registered under such section 804 on the 
     date that is 1 year after the date of enactment of this Act.
       (2) Review of registration by certain exporters.--
       (A) Review priority.--In the review of registrations 
     submitted under subsection (b) of such section 804, 
     registrations submitted by entities in Canada that are 
     significant exporters of prescription drugs to individuals in 
     the United States as of the date of enactment of this Act 
     will have priority during the 90 day period that begins on 
     such date of enactment.
       (B) Period for review.--During such 90-day period, the 
     reference in subsection (b)(2)(A) of such section 804 to 90 
     days (relating to approval or disapproval of registrations) 
     is, as applied to such entities, deemed to be 30 days.
       (C) Limitation.--That an exporter in Canada exports, or has 
     exported, prescription drugs to individuals in the United 
     States on or before the date that is 90 days after the date 
     of enactment of this Act shall not serve as a basis, in whole 
     or in part, for disapproving a registration under such 
     section 804 from the exporter.
       (D) First year limit on number of exporters.--During the 1-
     year period beginning on the date of enactment of this Act, 
     the Secretary of Health and Human Services (referred to in 
     this section as the ``Secretary'') may limit the number of 
     registered exporters under such section 804 to not less than 
     50, so long as the Secretary gives priority to those 
     exporters with demonstrated ability to process a high volume 
     of shipments of drugs to individuals in the United States.
       (E) Second year limit on number of exporters.--During the 
     1-year period beginning on the date that is 1 year after the 
     date of enactment of this Act, the Secretary may limit the 
     number of registered exporters under such section 804 to not 
     less than 100, so long as the Secretary gives priority to 
     those exporters with demonstrated ability to process a high 
     volume of shipments of drugs to individuals in the United 
     States.
       (F) Further limit on number of exporters.--During any 1-
     year period beginning on a date that is 2 or more years after 
     the date of enactment of this Act, the Secretary may limit 
     the number of registered exporters under such section 804 to 
     not less than 25 more than the number of such exporters 
     during the previous 1-year period, so long as the Secretary 
     gives priority to those exporters with demonstrated ability 
     to process a high volume of shipments of drugs to individuals 
     in the United States.
       (3) Limits on number of importers.--
       (A) First year limit on number of importers.--During the 1-
     year period beginning on the date that is 1 year after the 
     date of enactment of this Act, the Secretary may limit the 
     number of registered importers under such section 804 to not 
     less than 100 (of which at least a significant number shall 
     be groups of pharmacies, to the extent feasible given the 
     applications submitted by such groups), so long as the 
     Secretary gives priority to those importers with demonstrated 
     ability to process a high volume of shipments of drugs 
     imported into the United States.
       (B) Second year limit on number of importers.--During the 
     1-year period beginning on the date that is 2 years after the 
     date of enactment of this Act, the Secretary may limit the 
     number of registered importers under such section 804 to not 
     less than 200 (of which at least a significant number shall 
     be groups of pharmacies, to the extent feasible given the 
     applications submitted by such groups), so long as the 
     Secretary gives priority to those importers with demonstrated 
     ability to process a high volume of shipments of drugs into 
     the United States.
       (C) Further limit on number of importers.--During any 1-
     year period beginning on a date that is 3 or more years after 
     the date of enactment of this Act, the Secretary may limit 
     the number of registered importers under such section 804 to 
     not less than 50 more (of which at least a significant number 
     shall be groups of pharmacies, to the extent feasible given 
     the applications submitted by such groups) than the number of 
     such importers during the previous 1-year period, so long as 
     the Secretary gives priority to those importers with 
     demonstrated ability to process a high volume of shipments of 
     drugs to the United States.
       (4) Notices for drugs for import from canada.--The notice 
     with respect to a qualifying drug introduced for commercial 
     distribution in Canada as of the date of enactment of this 
     Act that is required under subsection (g)(2)(B)(i) of such 
     section 804 shall be submitted to the Secretary not later 
     than

[[Page 4934]]

     30 days after the date of enactment of this Act if--
       (A) the U.S. label drug (as defined in such section 804) 
     for the qualifying drug is 1 of the 100 prescription drugs 
     with the highest dollar volume of sales in the United States 
     based on the 12 calendar month period most recently completed 
     before the date of enactment of this Act; or
       (B) the notice is a notice under subsection 
     (g)(2)(B)(i)(II) of such section 804.
       (5) Notice for drugs for import from other countries.--The 
     notice with respect to a qualifying drug introduced for 
     commercial distribution in a permitted country other than 
     Canada as of the date of enactment of this Act that is 
     required under subsection (g)(2)(B)(i) of such section 804 
     shall be submitted to the Secretary not later than 180 days 
     after the date of enactment of this Act if--
       (A) the U.S. label drug for the qualifying drug is 1 of the 
     100 prescription drugs with the highest dollar volume of 
     sales in the United States based on the 12 calendar month 
     period that is first completed on the date that is 120 days 
     after the date of enactment of this Act; or
       (B) the notice is a notice under subsection 
     (g)(2)(B)(i)(II) of such section 804.
       (6) Notice for other drugs for import.--
       (A) Guidance on submission dates.--The Secretary shall by 
     guidance establish a series of submission dates for the 
     notices under subsection (g)(2)(B)(i) of such section 804 
     with respect to qualifying drugs introduced for commercial 
     distribution as of the date of enactment of this Act and that 
     are not required to be submitted under paragraph (4) or (5).
       (B) Consistent and efficient use of resources.--The 
     Secretary shall establish the dates described under 
     subparagraph (A) so that such notices described under 
     subparagraph (A) are submitted and reviewed at a rate that 
     allows consistent and efficient use of the resources and 
     staff available to the Secretary for such reviews. The 
     Secretary may condition the requirement to submit such a 
     notice, and the review of such a notice, on the submission by 
     a registered exporter or a registered importer to the 
     Secretary of a notice that such exporter or importer intends 
     to import such qualifying drug to the United States under 
     such section 804.
       (C) Priority for drugs with higher sales.--The Secretary 
     shall establish the dates described under subparagraph (A) so 
     that the Secretary reviews the notices described under such 
     subparagraph with respect to qualifying drugs with higher 
     dollar volume of sales in the United States before the 
     notices with respect to drugs with lower sales in the United 
     States.
       (7) Notices for drugs approved after effective date.--The 
     notice required under subsection (g)(2)(B)(i) of such section 
     804 for a qualifying drug first introduced for commercial 
     distribution in a permitted country (as defined in such 
     section 804) after the date of enactment of this Act shall be 
     submitted to and reviewed by the Secretary as provided under 
     subsection (g)(2)(B) of such section 804, without regard to 
     paragraph (4), (5), or (6).
       (8) Report.--Beginning with the first full fiscal year 
     after the date of enactment of this Act, not later than 90 
     days after the end of each fiscal year during which the 
     Secretary reviews a notice referred to in paragraph (4), (5), 
     or (6), the Secretary shall submit a report to Congress 
     concerning the progress of the Food and Drug Administration 
     in reviewing the notices referred to in paragraphs (4), (5), 
     and (6).
       (9) User fees.--
       (A) Exporters.--When establishing an aggregate total of 
     fees to be collected from exporters under subsection (f)(2) 
     of such section 804, the Secretary shall, under subsection 
     (f)(3)(C)(i) of such section 804, estimate the total price of 
     drugs imported under subsection (a) of such section 804 into 
     the United States by registered exporters during the first 
     fiscal year in which this title takes effect to be an amount 
     equal to the amount which bears the same ratio to 
     $1,000,000,000 as the number of days in such fiscal year 
     during which this title is effective bears to 365.
       (B) Importers.--When establishing an aggregate total of 
     fees to be collected from importers under subsection (e)(2) 
     of such section 804, the Secretary shall, under subsection 
     (e)(3)(C)(i) of such section 804, estimate the total price of 
     drugs imported under subsection (a) of such section 804 into 
     the United States by registered importers during--
       (i) the first fiscal year in which this title takes effect 
     to be an amount equal to the amount which bears the same 
     ratio to $1,000,000,000 as the number of days in such fiscal 
     year during which this title is effective bears to 365; and
       (ii) the second fiscal year in which this title is in 
     effect to be $3,000,000,000.
       (C) Second year adjustment.--
       (i) Reports.--Not later than February 20 of the second 
     fiscal year in which this title is in effect, registered 
     importers shall report to the Secretary the total price and 
     the total volume of drugs imported to the United States by 
     the importer during the 4-month period from October 1 through 
     January 31 of such fiscal year.
       (ii) Reestimate.--Notwithstanding subsection (e)(3)(C)(ii) 
     of such section 804 or subparagraph (B), the Secretary shall 
     reestimate the total price of qualifying drugs imported under 
     subsection (a) of such section 804 into the United States by 
     registered importers during the second fiscal year in which 
     this title is in effect. Such reestimate shall be equal to--

       (I) the total price of qualifying drugs imported by each 
     importer as reported under clause (i); multiplied by
       (II) 3.

       (iii) Adjustment.--The Secretary shall adjust the fee due 
     on April 1 of the second fiscal year in which this title is 
     in effect, from each importer so that the aggregate total of 
     fees collected under subsection (e)(2) for such fiscal year 
     does not exceed the total price of qualifying drugs imported 
     under subsection (a) of such section 804 into the United 
     States by registered importers during such fiscal year as 
     reestimated under clause (ii).
       (D) Failure to pay fees.--Notwithstanding any other 
     provision of this section, the Secretary may prohibit a 
     registered importer or exporter that is required to pay user 
     fees under subsection (e) or (f) of such section 804 and that 
     fails to pay such fees within 30 days after the date on which 
     it is due, from importing or offering for importation a 
     qualifying drug under such section 804 until such fee is 
     paid.
       (E) Annual report.--
       (i) Food and drug administration.--Not later than 180 days 
     after the end of each fiscal year during which fees are 
     collected under subsection (e), (f), or (g)(2)(B)(iv) of such 
     section 804, the Secretary shall prepare and submit to the 
     House of Representatives and the Senate a report on the 
     implementation of the authority for such fees during such 
     fiscal year and the use, by the Food and Drug Administration, 
     of the fees collected for the fiscal year for which the 
     report is made and credited to the Food and Drug 
     Administration.
       (ii) Customs and border protection.--Not later than 180 
     days after the end of each fiscal year during which fees are 
     collected under subsection (e) or (f) of such section 804, 
     the Secretary of Homeland Security, in consultation with the 
     Secretary of the Treasury, shall prepare and submit to the 
     House of Representatives and the Senate a report on the use, 
     by the Bureau of Customs and Border Protection, of the fees, 
     if any, transferred by the Secretary to the Bureau of Customs 
     and Border Protection for the fiscal year for which the 
     report is made.
       (10) Special rule regarding importation by individuals.--
       (A) In general.--Notwithstanding any provision of this 
     title (or an amendment made by this title), the Secretary 
     shall expedite the designation of any additional permitted 
     countries from which an individual may import a qualifying 
     drug into the United States under such section 804 if any 
     action implemented by the Government of Canada has the effect 
     of limiting or prohibiting the importation of qualifying 
     drugs into the United States from Canada.
       (B) Timing and criteria.--The Secretary shall designate 
     such additional permitted countries under subparagraph (A)--
       (i) not later than 6 months after the date of the action by 
     the Government of Canada described under such subparagraph; 
     and
       (ii) using the criteria described under subsection 
     (a)(4)(D)(i)(II) of such section 804.
       (f) Implementation of Section 804.--
       (1) Interim rule.--The Secretary may promulgate an interim 
     rule for implementing section 804 of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (a) of this section.
       (2) No notice of proposed rulemaking.--The interim rule 
     described under paragraph (1) may be developed and 
     promulgated by the Secretary without providing general notice 
     of proposed rulemaking.
       (3) Final rule.--Not later than 1 year after the date on 
     which the Secretary promulgates an interim rule under 
     paragraph (1), the Secretary shall, in accordance with 
     procedures under section 553 of title 5, United States Code, 
     promulgate a final rule for implementing such section 804, 
     which may incorporate by reference provisions of the interim 
     rule provided for under paragraph (1), to the extent that 
     such provisions are not modified.
       (g) Consumer Education.--The Secretary shall carry out 
     activities that educate consumers--
       (1) with regard to the availability of qualifying drugs for 
     import for personal use from an exporter registered with and 
     approved by the Food and Drug Administration under section 
     804 of the Federal Food, Drug, and Cosmetic Act, as added by 
     this section, including information on how to verify whether 
     an exporter is registered and approved by use of the Internet 
     website of the Food and Drug Administration and the toll-free 
     telephone number required by this title;
       (2) that drugs that consumers attempt to import from an 
     exporter that is not registered with and approved by the Food 
     and Drug Administration can be seized by the United States 
     Customs Service and destroyed, and that such drugs may be 
     counterfeit, unapproved, unsafe, or ineffective;
       (3) with regard to the suspension and termination of any 
     registration of a registered importer or exporter under such 
     section 804; and
       (4) with regard to the availability at domestic retail 
     pharmacies of qualifying drugs

[[Page 4935]]

     imported under such section 804 by domestic wholesalers and 
     pharmacies registered with and approved by the Food and Drug 
     Administration.
       (h) Effect on Administration Practices.--Notwithstanding 
     any provision of this title (and the amendments made by this 
     title), the practices and policies of the Food and Drug 
     Administration and Bureau of Customs and Border Protection, 
     in effect on January 1, 2004, with respect to the importation 
     of prescription drugs into the United States by an 
     individual, on the person of such individual, for personal 
     use, shall remain in effect.
       (i) Report to Congress.--The Federal Trade Commission 
     shall, on an annual basis, submit to Congress a report that 
     describes any action taken during the period for which the 
     report is being prepared to enforce the provisions of section 
     804(n) of the Federal Food, Drug, and Cosmetic Act (as added 
     by this title), including any pending investigations or civil 
     actions under such section.

     SEC. 3005. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION INTO 
                   UNITED STATES.

       (a) In General.--Chapter VIII of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381 et seq.), as amended by 
     section 3004, is further amended by adding at the end the 
     following section:

     ``SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION.

       ``(a) In General.--The Secretary of Homeland Security shall 
     deliver to the Secretary a shipment of drugs that is imported 
     or offered for import into the United States if--
       ``(1) the shipment has a declared value of less than 
     $10,000; and
       ``(2)(A) the shipping container for such drugs does not 
     bear the markings required under section 804(d)(2); or
       ``(B) the Secretary has requested delivery of such shipment 
     of drugs.
       ``(b) No Bond or Export.--Section 801(b) does not authorize 
     the delivery to the owner or consignee of drugs delivered to 
     the Secretary under subsection (a) pursuant to the execution 
     of a bond, and such drugs may not be exported.
       ``(c) Destruction of Violative Shipment.--The Secretary 
     shall destroy a shipment of drugs delivered by the Secretary 
     of Homeland Security to the Secretary under subsection (a) 
     if--
       ``(1) in the case of drugs that are imported or offered for 
     import from a registered exporter under section 804, the 
     drugs are in violation of any standard described in section 
     804(g)(5); or
       ``(2) in the case of drugs that are not imported or offered 
     for import from a registered exporter under section 804, the 
     drugs are in violation of a standard referred to in section 
     801(a) or 801(d)(1).
       ``(d) Certain Procedures.--
       ``(1) In general.--The delivery and destruction of drugs 
     under this section may be carried out without notice to the 
     importer, owner, or consignee of the drugs except as required 
     by section 801(g) or section 804(i)(2). The issuance of 
     receipts for the drugs, and recordkeeping activities 
     regarding the drugs, may be carried out on a summary basis.
       ``(2) Objective of procedures.--Procedures promulgated 
     under paragraph (1) shall be designed toward the objective of 
     ensuring that, with respect to efficiently utilizing Federal 
     resources available for carrying out this section, a 
     substantial majority of shipments of drugs subject to 
     described in subsection (c) are identified and destroyed.
       ``(e) Evidence Exception.--Drugs may not be destroyed under 
     subsection (c) to the extent that the Attorney General of the 
     United States determines that the drugs should be preserved 
     as evidence or potential evidence with respect to an offense 
     against the United States.
       ``(f) Rule of Construction.--This section may not be 
     construed as having any legal effect on applicable law with 
     respect to a shipment of drugs that is imported or offered 
     for import into the United States and has a declared value 
     equal to or greater than $10,000.''.
       (b) Procedures.--Procedures for carrying out section 805 of 
     the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (a), shall be established not later than 90 days 
     after the date of the enactment of this Act.
       (c) Effective Date.--The amendments made by this section 
     shall take effect on the date that is 90 days after the date 
     of enactment of this Act.

     SEC. 3006. WHOLESALE DISTRIBUTION OF DRUGS; STATEMENTS 
                   REGARDING PRIOR SALE, PURCHASE, OR TRADE.

       (a) Striking of Exemptions; Applicability to Registered 
     Exporters.--Section 503(e) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 353(e)) is amended--
       (1) in paragraph (1)--
       (A) by striking ``and who is not the manufacturer or an 
     authorized distributor of record of such drug'';
       (B) by striking ``to an authorized distributor of record 
     or''; and
       (C) by striking subparagraph (B) and inserting the 
     following:
       ``(B) The fact that a drug subject to subsection (b) is 
     exported from the United States does not with respect to such 
     drug exempt any person that is engaged in the business of the 
     wholesale distribution of the drug from providing the 
     statement described in subparagraph (A) to the person that 
     receives the drug pursuant to the export of the drug.
       ``(C)(i) The Secretary shall by regulation establish 
     requirements that supersede subparagraph (A) (referred to in 
     this subparagraph as `alternative requirements') to identify 
     the chain of custody of a drug subject to subsection (b) from 
     the manufacturer of the drug throughout the wholesale 
     distribution of the drug to a pharmacist who intends to sell 
     the drug at retail if the Secretary determines that the 
     alternative requirements, which may include standardized 
     anti-counterfeiting or track-and-trace technologies, will 
     identify such chain of custody or the identity of the 
     discrete package of the drug from which the drug is dispensed 
     with equal or greater certainty to the requirements of 
     subparagraph (A), and that the alternative requirements are 
     economically and technically feasible.
       ``(ii) When the Secretary promulgates a final rule to 
     establish such alternative requirements, the final rule in 
     addition shall, with respect to the registration condition 
     established in clause (i) of section 804(c)(3)(B), establish 
     a condition equivalent to the alternative requirements, and 
     such equivalent condition may be met in lieu of the 
     registration condition established in such clause (i).'';
       (2) in paragraph (2)(A), by adding at the end the 
     following: ``The preceding sentence may not be construed as 
     having any applicability with respect to a registered 
     exporter under section 804.''; and
       (3) in paragraph (3), by striking ``and subsection (d)--'' 
     in the matter preceding subparagraph (A) and all that follows 
     through ``the term `wholesale distribution' means'' in 
     subparagraph (B) and inserting the following: ``and 
     subsection (d), the term `wholesale distribution' means''.
       (b) Conforming Amendment.--Section 503(d) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 353(d)) is amended by 
     adding at the end the following:
       ``(4) Each manufacturer of a drug subject to subsection (b) 
     shall maintain at its corporate offices a current list of the 
     authorized distributors of record of such drug.
       ``(5) For purposes of this subsection, the term `authorized 
     distributors of record' means those distributors with whom a 
     manufacturer has established an ongoing relationship to 
     distribute such manufacturer's products.''.
       (c) Effective Date.--
       (1) In general.--The amendments made by paragraphs (1) and 
     (3) of subsection (a) and by subsection (b) shall take effect 
     on January 1, 2012.
       (2) Drugs imported by registered importers under section 
     804.--Notwithstanding paragraph (1), the amendments made by 
     paragraphs (1) and (3) of subsection (a) and by subsection 
     (b) shall take effect on the date that is 90 days after the 
     date of enactment of this Act with respect to qualifying 
     drugs imported under section 804 of the Federal Food, Drug, 
     and Cosmetic Act, as added by section 3004.
       (3) Effect with respect to registered exporters.--The 
     amendment made by subsection (a)(2) shall take effect on the 
     date that is 90 days after the date of enactment of this Act.
       (4) Alternative requirements.--The Secretary shall issue 
     regulations to establish the alternative requirements, 
     referred to in the amendment made by subsection (a)(1), that 
     take effect not later than January 1, 2012.
       (5) Intermediate requirements.--The Secretary shall by 
     regulation require the use of standardized anti-
     counterfeiting or track-and-trace technologies on 
     prescription drugs at the case and pallet level effective not 
     later than 1 year after the date of enactment of this Act.
       (6) Additional requirements.--
       (A) In general.--Notwithstanding any other provision of 
     this section, the Secretary shall, not later than 18 months 
     after the date of enactment of this Act, require that the 
     packaging of any prescription drug incorporates--
       (i) a standardized numerical identifier unique to each 
     package of such drug, applied at the point of manufacturing 
     and repackaging (in which case the numerical identifier shall 
     be linked to the numerical identifier applied at the point of 
     manufacturing); and
       (ii)(I) overt optically variable counterfeit-resistant 
     technologies that--

       (aa) are visible to the naked eye, providing for visual 
     identification of product authenticity without the need for 
     readers, microscopes, lighting devices, or scanners;
       (bb) are similar to that used by the Bureau of Engraving 
     and Printing to secure United States currency;
       (cc) are manufactured and distributed in a highly secure, 
     tightly controlled environment; and
       (dd) incorporate additional layers of nonvisible convert 
     security features up to and including forensic capability, as 
     described in subparagraph (B); or

       (II) technologies that have a function of security 
     comparable to that described in subclause (I), as determined 
     by the Secretary.
       (B) Standards for packaging.--For the purpose of making it 
     more difficult to counterfeit the packaging of drugs subject 
     to this

[[Page 4936]]

     paragraph, the manufacturers of such drugs shall incorporate 
     the technologies described in subparagraph (A) into at least 
     1 additional element of the physical packaging of the drugs, 
     including blister packs, shrink wrap, package labels, package 
     seals, bottles, and boxes.

     SEC. 3007. INTERNET SALES OF PRESCRIPTION DRUGS.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 503B the following:

     ``SEC. 503C. INTERNET SALES OF PRESCRIPTION DRUGS.

       ``(a) Requirements Regarding Information on Internet 
     Site.--
       ``(1) In general.--A person may not dispense a prescription 
     drug pursuant to a sale of the drug by such person if--
       ``(A) the purchaser of the drug submitted the purchase 
     order for the drug, or conducted any other part of the sales 
     transaction for the drug, through an Internet site;
       ``(B) the person dispenses the drug to the purchaser by 
     mailing or shipping the drug to the purchaser; and
       ``(C) such site, or any other Internet site used by such 
     person for purposes of sales of a prescription drug, fails to 
     meet each of the requirements specified in paragraph (2), 
     other than a site or pages on a site that--
       ``(i) are not intended to be accessed by purchasers or 
     prospective purchasers; or
       ``(ii) provide an Internet information location tool within 
     the meaning of section 231(e)(5) of the Communications Act of 
     1934 (47 U.S.C. 231(e)(5)).
       ``(2) Requirements.--With respect to an Internet site, the 
     requirements referred to in subparagraph (C) of paragraph (1) 
     for a person to whom such paragraph applies are as follows:
       ``(A) Each page of the site shall include either the 
     following information or a link to a page that provides the 
     following information:
       ``(i) The name of such person.
       ``(ii) Each State in which the person is authorized by law 
     to dispense prescription drugs.
       ``(iii) The address and telephone number of each place of 
     business of the person with respect to sales of prescription 
     drugs through the Internet, other than a place of business 
     that does not mail or ship prescription drugs to purchasers.
       ``(iv) The name of each individual who serves as a 
     pharmacist for prescription drugs that are mailed or shipped 
     pursuant to the site, and each State in which the individual 
     is authorized by law to dispense prescription drugs.
       ``(v) If the person provides for medical consultations 
     through the site for purposes of providing prescriptions, the 
     name of each individual who provides such consultations; each 
     State in which the individual is licensed or otherwise 
     authorized by law to provide such consultations or practice 
     medicine; and the type or types of health professions for 
     which the individual holds such licenses or other 
     authorizations.
       ``(B) A link to which paragraph (1) applies shall be 
     displayed in a clear and prominent place and manner, and 
     shall include in the caption for the link the words 
     `licensing and contact information'.
       ``(b) Internet Sales Without Appropriate Medical 
     Relationships.--
       ``(1) In general.--Except as provided in paragraph (2), a 
     person may not dispense a prescription drug, or sell such a 
     drug, if--
       ``(A) for purposes of such dispensing or sale, the 
     purchaser communicated with the person through the Internet;
       ``(B) the patient for whom the drug was dispensed or 
     purchased did not, when such communications began, have a 
     prescription for the drug that is valid in the United States;
       ``(C) pursuant to such communications, the person provided 
     for the involvement of a practitioner, or an individual 
     represented by the person as a practitioner, and the 
     practitioner or such individual issued a prescription for the 
     drug that was purchased;
       ``(D) the person knew, or had reason to know, that the 
     practitioner or the individual referred to in subparagraph 
     (C) did not, when issuing the prescription, have a qualifying 
     medical relationship with the patient; and
       ``(E) the person received payment for the dispensing or 
     sale of the drug.
     For purposes of subparagraph (E), payment is received if 
     money or other valuable consideration is received.
       ``(2) Exceptions.--Paragraph (1) does not apply to--
       ``(A) the dispensing or selling of a prescription drug 
     pursuant to telemedicine practices sponsored by--
       ``(i) a hospital that has in effect a provider agreement 
     under title XVIII of the Social Security Act (relating to the 
     Medicare program); or
       ``(ii) a group practice that has not fewer than 100 
     physicians who have in effect provider agreements under such 
     title; or
       ``(B) the dispensing or selling of a prescription drug 
     pursuant to practices that promote the public health, as 
     determined by the Secretary by regulation.
       ``(3) Qualifying medical relationship.--
       ``(A) In general.--With respect to issuing a prescription 
     for a drug for a patient, a practitioner has a qualifying 
     medical relationship with the patient for purposes of this 
     section if--
       ``(i) at least one in-person medical evaluation of the 
     patient has been conducted by the practitioner; or
       ``(ii) the practitioner conducts a medical evaluation of 
     the patient as a covering practitioner.
       ``(B) In-person medical evaluation.--A medical evaluation 
     by a practitioner is an in-person medical evaluation for 
     purposes of this section if the practitioner is in the 
     physical presence of the patient as part of conducting the 
     evaluation, without regard to whether portions of the 
     evaluation are conducted by other health professionals.
       ``(C) Covering practitioner.--With respect to a patient, a 
     practitioner is a covering practitioner for purposes of this 
     section if the practitioner conducts a medical evaluation of 
     the patient at the request of a practitioner who has 
     conducted at least one in-person medical evaluation of the 
     patient and is temporarily unavailable to conduct the 
     evaluation of the patient. A practitioner is a covering 
     practitioner without regard to whether the practitioner has 
     conducted any in-person medical evaluation of the patient 
     involved.
       ``(4) Rules of construction.--
       ``(A) Individuals represented as practitioners.--A person 
     who is not a practitioner (as defined in subsection (e)(1)) 
     lacks legal capacity under this section to have a qualifying 
     medical relationship with any patient.
       ``(B) Standard practice of pharmacy.--Paragraph (1) may not 
     be construed as prohibiting any conduct that is a standard 
     practice in the practice of pharmacy.
       ``(C) Applicability of requirements.--Paragraph (3) may not 
     be construed as having any applicability beyond this section, 
     and does not affect any State law, or interpretation of State 
     law, concerning the practice of medicine.
       ``(c) Actions by States.--
       ``(1) In general.--Whenever an attorney general of any 
     State has reason to believe that the interests of the 
     residents of that State have been or are being threatened or 
     adversely affected because any person has engaged or is 
     engaging in a pattern or practice that violates section 
     301(l), the State may bring a civil action on behalf of its 
     residents in an appropriate district court of the United 
     States to enjoin such practice, to enforce compliance with 
     such section (including a nationwide injunction), to obtain 
     damages, restitution, or other compensation on behalf of 
     residents of such State, to obtain reasonable attorneys fees 
     and costs if the State prevails in the civil action, or to 
     obtain such further and other relief as the court may deem 
     appropriate.
       ``(2) Notice.--The State shall serve prior written notice 
     of any civil action under paragraph (1) or (5)(B) upon the 
     Secretary and provide the Secretary with a copy of its 
     complaint, except that if it is not feasible for the State to 
     provide such prior notice, the State shall serve such notice 
     immediately upon instituting such action. Upon receiving a 
     notice respecting a civil action, the Secretary shall have 
     the right--
       ``(A) to intervene in such action;
       ``(B) upon so intervening, to be heard on all matters 
     arising therein; and
       ``(C) to file petitions for appeal.
       ``(3) Construction.--For purposes of bringing any civil 
     action under paragraph (1), nothing in this chapter shall 
     prevent an attorney general of a State from exercising the 
     powers conferred on the attorney general by the laws of such 
     State to conduct investigations or to administer oaths or 
     affirmations or to compel the attendance of witnesses or the 
     production of documentary and other evidence.
       ``(4) Venue; service of process.--Any civil action brought 
     under paragraph (1) in a district court of the United States 
     may be brought in the district in which the defendant is 
     found, is an inhabitant, or transacts business or wherever 
     venue is proper under section 1391 of title 28, United States 
     Code. Process in such an action may be served in any district 
     in which the defendant is an inhabitant or in which the 
     defendant may be found.
       ``(5) Actions by other state officials.--
       ``(A) Nothing contained in this section shall prohibit an 
     authorized State official from proceeding in State court on 
     the basis of an alleged violation of any civil or criminal 
     statute of such State.
       ``(B) In addition to actions brought by an attorney general 
     of a State under paragraph (1), such an action may be brought 
     by officers of such State who are authorized by the State to 
     bring actions in such State on behalf of its residents.
       ``(d) Effect of Section.--This section shall not apply to a 
     person that is a registered exporter under section 804.
       ``(e) General Definitions.--For purposes of this section:
       ``(1) The term `practitioner' means a practitioner referred 
     to in section 503(b)(1) with respect to issuing a written or 
     oral prescription.
       ``(2) The term `prescription drug' means a drug that is 
     described in section 503(b)(1).
       ``(3) The term `qualifying medical relationship', with 
     respect to a practitioner and a patient, has the meaning 
     indicated for such term in subsection (b).

[[Page 4937]]

       ``(f) Internet-Related Definitions.--
       ``(1) In general.--For purposes of this section:
       ``(A) The term `Internet' means collectively the myriad of 
     computer and telecommunications facilities, including 
     equipment and operating software, which comprise the 
     interconnected world-wide network of networks that employ the 
     transmission control protocol/internet protocol, or any 
     predecessor or successor protocols to such protocol, to 
     communicate information of all kinds by wire or radio.
       ``(B) The term `link', with respect to the Internet, means 
     one or more letters, words, numbers, symbols, or graphic 
     items that appear on a page of an Internet site for the 
     purpose of serving, when activated, as a method for executing 
     an electronic command--
       ``(i) to move from viewing one portion of a page on such 
     site to another portion of the page;
       ``(ii) to move from viewing one page on such site to 
     another page on such site; or
       ``(iii) to move from viewing a page on one Internet site to 
     a page on another Internet site.
       ``(C) The term `page', with respect to the Internet, means 
     a document or other file accessed at an Internet site.
       ``(D)(i) The terms `site' and `address', with respect to 
     the Internet, mean a specific location on the Internet that 
     is determined by Internet Protocol numbers. Such term 
     includes the domain name, if any.
       ``(ii) The term `domain name' means a method of 
     representing an Internet address without direct reference to 
     the Internet Protocol numbers for the address, including 
     methods that use designations such as `.com', `.edu', `.gov', 
     `.net', or `.org'.
       ``(iii) The term `Internet Protocol numbers' includes any 
     successor protocol for determining a specific location on the 
     Internet.
       ``(2) Authority of secretary.--The Secretary may by 
     regulation modify any definition under paragraph (1) to take 
     into account changes in technology.
       ``(g) Interactive Computer Service; Advertising.--No 
     provider of an interactive computer service, as defined in 
     section 230(f)(2) of the Communications Act of 1934 (47 
     U.S.C. 230(f)(2)), or of advertising services shall be liable 
     under this section for dispensing or selling prescription 
     drugs in violation of this section on account of another 
     person's selling or dispensing such drugs, provided that the 
     provider of the interactive computer service or of 
     advertising services does not own or exercise corporate 
     control over such person.
       ``(h) No Effect on Other Requirements; Coordination.--The 
     requirements of this section are in addition to, and do not 
     supersede, any requirements under the Controlled Substances 
     Act or the Controlled Substances Import and Export Act (or 
     any regulation promulgated under either such Act) regarding 
     Internet pharmacies and controlled substances. In 
     promulgating regulations to carry out this section, the 
     Secretary shall coordinate with the Attorney General to 
     ensure that such regulations do not duplicate or conflict 
     with the requirements described in the previous sentence, and 
     that such regulations and requirements coordinate to the 
     extent practicable.''.
       (b) Inclusion as Prohibited Act.--Section 301 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is 
     amended by inserting after paragraph (k) the following:
       ``(l) The dispensing or selling of a prescription drug in 
     violation of section 503C.''.
       (c) Internet Sales of Prescription Drugs; Consideration by 
     Secretary of Practices and Procedures for Certification of 
     Legitimate Businesses.--In carrying out section 503C of the 
     Federal Food, Drug, and Cosmetic Act (as added by subsection 
     (a) of this section), the Secretary of Health and Human 
     Services shall take into consideration the practices and 
     procedures of public or private entities that certify that 
     businesses selling prescription drugs through Internet sites 
     are legitimate businesses, including practices and procedures 
     regarding disclosure formats and verification programs.
       (d) Reports Regarding Internet-Related Violations of 
     Federal and State Laws on Dispensing of Drugs.--
       (1) In general.--The Secretary of Health and Human Services 
     (referred to in this subsection as the ``Secretary'') shall, 
     pursuant to the submission of an application meeting the 
     criteria of the Secretary, make an award of a grant or 
     contract to the National Clearinghouse on Internet 
     Prescribing (operated by the Federation of State Medical 
     Boards) for the purpose of--
       (A) identifying Internet sites that appear to be in 
     violation of Federal or State laws concerning the dispensing 
     of drugs;
       (B) reporting such sites to State medical licensing boards 
     and State pharmacy licensing boards, and to the Attorney 
     General and the Secretary, for further investigation; and
       (C) submitting, for each fiscal year for which the award 
     under this subsection is made, a report to the Secretary 
     describing investigations undertaken with respect to 
     violations described in subparagraph (A).
       (2) Authorization of appropriations.--For the purpose of 
     carrying out paragraph (1), there is authorized to be 
     appropriated $100,000 for each of the first 3 fiscal years in 
     which this section is in effect.
       (e) Effective Date.--The amendments made by subsections (a) 
     and (b) take effect 90 days after the date of enactment of 
     this Act, without regard to whether a final rule to implement 
     such amendments has been promulgated by the Secretary of 
     Health and Human Services under section 701(a) of the Federal 
     Food, Drug, and Cosmetic Act. The preceding sentence may not 
     be construed as affecting the authority of such Secretary to 
     promulgate such a final rule.

     SEC. 3008. PROHIBITING PAYMENTS TO UNREGISTERED FOREIGN 
                   PHARMACIES.

       (a) In General.--Section 303 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 333) is amended by adding at the end 
     the following:
       ``(h) Restricted Transactions.--
       ``(1) In general.--The introduction of restricted 
     transactions into a payment system or the completion of 
     restricted transactions using a payment system is prohibited.
       ``(2) Payment system.--
       ``(A) In general.--The term `payment system' means a system 
     used by a person described in subparagraph (B) to effect a 
     credit transaction, electronic fund transfer, or money 
     transmitting service that may be used in connection with, or 
     to facilitate, a restricted transaction, and includes--
       ``(i) a credit card system;
       ``(ii) an international, national, regional, or local 
     network used to effect a credit transaction, an electronic 
     fund transfer, or a money transmitting service; and
       ``(iii) any other system that is centrally managed and is 
     primarily engaged in the transmission and settlement of 
     credit transactions, electronic fund transfers, or money 
     transmitting services.
       ``(B) Persons described.--A person referred to in 
     subparagraph (A) is--
       ``(i) a creditor;
       ``(ii) a credit card issuer;
       ``(iii) a financial institution;
       ``(iv) an operator of a terminal at which an electronic 
     fund transfer may be initiated;
       ``(v) a money transmitting business; or
       ``(vi) a participant in an international, national, 
     regional, or local network used to effect a credit 
     transaction, electronic fund transfer, or money transmitting 
     service.
       ``(3) Restricted transaction.--The term `restricted 
     transaction' means a transaction or transmittal, on behalf of 
     an individual who places an unlawful drug importation request 
     to any person engaged in the operation of an unregistered 
     foreign pharmacy, of--
       ``(A) credit, or the proceeds of credit, extended to or on 
     behalf of the individual for the purpose of the unlawful drug 
     importation request (including credit extended through the 
     use of a credit card);
       ``(B) an electronic fund transfer or funds transmitted by 
     or through a money transmitting business, or the proceeds of 
     an electronic fund transfer or money transmitting service, 
     from or on behalf of the individual for the purpose of the 
     unlawful drug importation request;
       ``(C) a check, draft, or similar instrument which is drawn 
     by or on behalf of the individual for the purpose of the 
     unlawful drug importation request and is drawn on or payable 
     at or through any financial institution; or
       ``(D) the proceeds of any other form of financial 
     transaction (identified by the Board by regulation) that 
     involves a financial institution as a payor or financial 
     intermediary on behalf of or for the benefit of the 
     individual for the purpose of the unlawful drug importation 
     request.
       ``(4) Unlawful drug importation request.--The term 
     `unlawful drug importation request' means the request, or 
     transmittal of a request, made to an unregistered foreign 
     pharmacy for a prescription drug by mail (including a private 
     carrier), facsimile, phone, or electronic mail, or by a means 
     that involves the use, in whole or in part, of the Internet.
       ``(5) Unregistered foreign pharmacy.--The term 
     `unregistered foreign pharmacy' means a person in a country 
     other than the United States that is not a registered 
     exporter under section 804.
       ``(6) Other definitions.--
       ``(A) Credit; creditor; credit card.--The terms `credit', 
     `creditor', and `credit card' have the meanings given the 
     terms in section 103 of the Truth in Lending Act (15 U.S.C. 
     1602).
       ``(B) Access device; electronic fund transfer.--The terms 
     `access device' and `electronic fund transfer'--
       ``(i) have the meaning given the term in section 903 of the 
     Electronic Fund Transfer Act (15 U.S.C. 1693a); and
       ``(ii) the term `electronic fund transfer' also includes 
     any fund transfer covered under Article 4A of the Uniform 
     Commercial Code, as in effect in any State.
       ``(C) Financial institution.--The term `financial 
     institution'--
       ``(i) has the meaning given the term in section 903 of the 
     Electronic Transfer Fund Act (15 U.S.C. 1693a); and
       ``(ii) includes a financial institution (as defined in 
     section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809)).
       ``(D) Money transmitting business; money transmitting 
     service.--The terms `money transmitting business' and `money 
     transmitting service' have the meaning given the

[[Page 4938]]

     terms in section 5330(d) of title 31, United States Code.
       ``(E) Board.--The term `Board' means the Board of Governors 
     of the Federal Reserve System.
       ``(7) Policies and procedures required to prevent 
     restricted transactions.--
       ``(A) Regulations.--The Board shall promulgate regulations 
     requiring--
       ``(i) an operator of a credit card system;
       ``(ii) an operator of an international, national, regional, 
     or local network used to effect a credit transaction, an 
     electronic fund transfer, or a money transmitting service;
       ``(iii) an operator of any other payment system that is 
     centrally managed and is primarily engaged in the 
     transmission and settlement of credit transactions, 
     electronic transfers or money transmitting services where at 
     least one party to the transaction or transfer is an 
     individual; and
       ``(iv) any other person described in paragraph (2)(B) and 
     specified by the Board in such regulations,
     to establish policies and procedures that are reasonably 
     designed to prevent the introduction of a restricted 
     transaction into a payment system or the completion of a 
     restricted transaction using a payment system
       ``(B) Requirements for policies and procedures.--In 
     promulgating regulations under subparagraph (A), the Board 
     shall--
       ``(i) identify types of policies and procedures, including 
     nonexclusive examples, that shall be considered to be 
     reasonably designed to prevent the introduction of restricted 
     transactions into a payment system or the completion of 
     restricted transactions using a payment system; and
       ``(ii) to the extent practicable, permit any payment 
     system, or person described in paragraph (2)(B), as 
     applicable, to choose among alternative means of preventing 
     the introduction or completion of restricted transactions.
       ``(C) No liability for blocking or refusing to honor 
     restricted transaction.--
       ``(i) In general.--A payment system, or a person described 
     in paragraph (2)(B) that is subject to a regulation issued 
     under this subsection, and any participant in such payment 
     system that prevents or otherwise refuses to honor 
     transactions in an effort to implement the policies and 
     procedures required under this subsection or to otherwise 
     comply with this subsection shall not be liable to any party 
     for such action.
       ``(ii) Compliance.--A person described in paragraph (2)(B) 
     meets the requirements of this subsection if the person 
     relies on and complies with the policies and procedures of a 
     payment system of which the person is a member or in which 
     the person is a participant, and such policies and procedures 
     of the payment system comply with the requirements of the 
     regulations promulgated under subparagraph (A).
       ``(D) Enforcement.--
       ``(i) In general.--This subsection, and the regulations 
     promulgated under this subsection, shall be enforced 
     exclusively by the Federal functional regulators and the 
     Federal Trade Commission under applicable law in the manner 
     provided in section 505(a) of the Gramm-Leach-Bliley Act (15 
     U.S.C. 6805(a)).
       ``(ii) Factors to be considered.--In considering any 
     enforcement action under this subsection against a payment 
     system or person described in paragraph (2)(B), the Federal 
     functional regulators and the Federal Trade Commission shall 
     consider the following factors:

       ``(I) The extent to which the payment system or person 
     knowingly permits restricted transactions.
       ``(II) The history of the payment system or person in 
     connection with permitting restricted transactions.
       ``(III) The extent to which the payment system or person 
     has established and is maintaining policies and procedures in 
     compliance with regulations prescribed under this subsection.

       ``(8) Transactions permitted.--A payment system, or a 
     person described in paragraph (2)(B) that is subject to a 
     regulation issued under this subsection, is authorized to 
     engage in transactions with foreign pharmacies in connection 
     with investigating violations or potential violations of any 
     rule or requirement adopted by the payment system or person 
     in connection with complying with paragraph (7). A payment 
     system, or such a person, and its agents and employees shall 
     not be found to be in violation of, or liable under, any 
     Federal, State or other law by virtue of engaging in any such 
     transaction.
       ``(9) Relation to state laws.--No requirement, prohibition, 
     or liability may be imposed on a payment system, or a person 
     described in paragraph (2)(B) that is subject to a regulation 
     issued under this subsection, under the laws of any state 
     with respect to any payment transaction by an individual 
     because the payment transaction involves a payment to a 
     foreign pharmacy.
       ``(10) Timing of requirements.--A payment system, or a 
     person described in paragraph (2)(B) that is subject to a 
     regulation issued under this subsection, must adopt policies 
     and procedures reasonably designed to comply with any 
     regulations required under paragraph (7) within 60 days after 
     such regulations are issued in final form.
       ``(11) Compliance.--A payment system, and any person 
     described in paragraph (2)(B), shall not be deemed to be in 
     violation of paragraph (1)--
       ``(A)(i) if an alleged violation of paragraph (1) occurs 
     prior to the mandatory compliance date of the regulations 
     issued under paragraph (7); and
       ``(ii) such entity has adopted or relied on policies and 
     procedures that are reasonably designed to prevent the 
     introduction of restricted transactions into a payment system 
     or the completion of restricted transactions using a payment 
     system; or
       ``(B)(i) if an alleged violation of paragraph (1) occurs 
     after the mandatory compliance date of such regulations; and
       ``(ii) such entity is in compliance with such 
     regulations.''.
       (b) Effective Date.--The amendment made by this section 
     shall take effect on the day that is 90 days after the date 
     of enactment of this Act.
       (c) Implementation.--The Board of Governors of the Federal 
     Reserve System shall promulgate regulations as required by 
     subsection (h)(7) of section 303 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 333), as added by subsection (a), 
     not later than 90 days after the date of enactment of this 
     Act.

     SEC. 3009. IMPORTATION EXEMPTION UNDER CONTROLLED SUBSTANCES 
                   IMPORT AND EXPORT ACT.

       Section 1006(a)(2) of the Controlled Substances Import and 
     Export Act (21 U.S.C. 956(a)(2)) is amended by striking ``not 
     import the controlled substance into the United States in an 
     amount that exceeds 50 dosage units of the controlled 
     substance.'' and inserting ``import into the United States 
     not more than 10 dosage units combined of all such controlled 
     substances.''.

     SEC. 3010. SEVERABILITY.

       If any provision of this title, an amendment 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 to any person 
     or circumstance shall not affected thereby.
                                 ______
                                 
  SA 3689. Mr. COBURN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, add the following:

     SEC. 1502. NO PAY RAISE FOR MEMBERS OF CONGRESS UNTIL THEY 
                   BALANCE THE BUDGET.

       (a) Restriction on COLA Adjustments.--Notwithstanding any 
     other provision of law, no adjustment shall be made under 
     section 601(a) of the Legislative Reorganization Act of 1946 
     (2 U.S.C. 31) (relating to cost of living adjustments for 
     Members of Congress) during fiscal year 2011 or any 
     succeeding fiscal year, until the fiscal year following the 
     first fiscal year that the annual Federal budget deficit is 
     $0 as determined in the report submitted under subsection 
     (b).
       (b) Determinations and Reports.--
       (1) In general.--Not later than 30 days after the end of 
     each fiscal year, the Secretary of the Treasury shall--
       (A) make a determination of whether or not the annual 
     Federal budget deficit was $0 for that fiscal year; and
       (B) if the determination is that the annual Federal budget 
     deficit was $0 for that fiscal year, submit a report to 
     Congress of that determination.
       (2) Restriction of cola adjustments.--Not later than the 
     end of each calendar year, the Secretary of the Treasury 
     shall submit a report to the Secretary of the Senate and the 
     Chief Administrative Officer of the House of Representatives 
     on--
       (A) any determination made under paragraph (1); and
       (B) whether or not the restriction under subsection (a) 
     shall apply to the succeeding fiscal year.
                                 ______
                                 
  SA 3690. Mr. BROWNBACK submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 113, after line 21, add the following:

     SEC. 1502. RELOCATION OF THE UNITED STATES EMBASSY TO 
                   JERUSALEM.

       (a) Removal of Waiver Authority.--The Jerusalem Embassy Act 
     of 1995 (Public Law 104-45; 109 Stat. 398) is amended--
       (1) by striking section 7; and
       (2) by redesignating section 8 as section 7.
       (b) Timetable.--Not more than 50 percent of the funds 
     appropriated to the Department of State for fiscal year 2012 
     for ``Acquisition and Maintenance of Buildings Abroad'' may 
     be obligated until the Secretary of State determines and 
     reports to Congress that the United States Embassy in 
     Jerusalem has officially opened.

[[Page 4939]]

       (c) Fiscal Years 2010 and 2011 Funding.--
       (1) Fiscal year 2010.--Of the funds authorized to be 
     appropriated for ``Acquisition and Maintenance of Buildings 
     Abroad'' for the Department of State for fiscal year 2010, 
     such sums as may be necessary shall be made available until 
     expended only for construction and other costs associated 
     with the establishment of the United States Embassy in Israel 
     in the capital of Jerusalem.
       (2) Fiscal year 2011.--Of the funds authorized to be 
     appropriated for ``Acquisition and Maintenance of Buildings 
     Abroad'' for the Department of State for fiscal year 2011, 
     such sums as may be necessary shall be made available until 
     expended only for construction and other costs associated 
     with the establishment of the United States Embassy in Israel 
     in the capital of Jerusalem.
       (d) Definition.--In this section, the term ``United States 
     Embassy'' means the offices of the United States diplomatic 
     mission and the residence of the United States chief of 
     mission.
                                 ______
                                 
  SA 3691. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, add the following:

     SEC. 1502. PAYMENT FOR ILLEGAL UNAPPROVED DRUGS.

       (a) Listing of Drugs and Devices.--Section 510 of the Food, 
     Drug and Cosmetic Act (21 U.S.C. 360) is amended--
       (1) in subsection (j)(1)(B)--
       (A) in clause (i), by inserting ``in the case of a drug, 
     the authority under this Act that does not require such drug 
     to be subject to section 505 and section 512,'' after 
     ``labeling for such drug or device,''; and
       (B) in clause (ii), by inserting ``, in the case of a drug, 
     the authority under this Act that does not require such drug 
     to be subject to section 505 and section 512,'' after ``for 
     such drug or device''; and
       (2) in subsection (f)--
       (A) by striking ``(f) The Secretary'' and inserting the 
     following:
       ``(f) Inspection by Public of Registration.--
       ``(1) In general.--The Secretary''; and
       (B) by adding at the end the following:
       ``(2) List of drugs that are not approved under section 505 
     or 512.--Not later than January 1, 2011, the Secretary shall 
     make available to the public on the Internet website of the 
     Food and Drug Administration a list that includes, for each 
     drug described in subsection (j)(1)(B)--
       ``(A) the drug;
       ``(B) the person who listed such drug; and
       ``(C) the authority under this Act that does not require 
     such drug to be subject to section 505 and section 512, as 
     provided by such person in such list.''.
       (b) Payment for Covered Outpatient Drugs.--Section 1927 of 
     the Social Security Act (42 U.S.C. 1396r-8) is amended by 
     inserting at the end the following:
       ``(l) Condition.--Beginning January 1, 2011, no State shall 
     make any payment under this section for any covered 
     outpatient drug unless such State first verifies with the 
     Food and Drug Administration that such covered outpatient 
     drug has been approved by the Food and Drug Administration 
     under a new drug application under section 505(b) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) or an 
     abbreviated new drug application under section 505(j) of such 
     Act, or that such drug is not subject to such section 505 or 
     section 512 due to the application of section 201(p) of such 
     Act (21 U.S.C. 321(p)). The Secretary shall have the 
     authority to proscribe regulations to create an information 
     sharing protocol to allow States to verify that a covered 
     outpatient drug has been approved by the Food and Drug 
     Administration.''.
                                 ______
                                 
  SA 3692. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

       On page 82, after line 9, insert the following:

     SEC. ___. EXTENSION AND EXPANSION OF OVERSIGHT FOR CLAIMS OF 
                   DME SUPPLIERS.

       Section 1866(j) of the Social Security Act, as amended by 
     section 1304, is further amended--
       (1) in paragraph (4)--
       (A) in the heading, by striking ``90-day'' and inserting 
     ``180-day''; and
       (B) by striking ``90-day'' and inserting ``180-day'';
       (2) by redesignating paragraphs (5) through (8) as 
     paragraphs (6) through (9), respectively; and
       (3) by inserting after paragraph (4) the following new 
     paragraph:
       ``(5) 180-day period of enhanced oversight and additional 
     review for other claims of dme suppliers.--For periods 
     beginning after January 1, 2011, if the Secretary determines 
     that there is a significant risk of fraudulent activity among 
     suppliers of durable medical equipment, in the case of a 
     supplier of durable medical equipment not described in 
     paragraph (4) who is within a category or geographic area 
     under title XVIII identified pursuant to such determination, 
     the Secretary shall, notwithstanding sections 1816(c), 
     1842(c), and 1869(a)(2)--
       ``(A) withhold payment under such title with respect to 
     durable medical equipment furnished by such supplier during 
     the 180-day period beginning on the date of such 
     determination; and
       ``(B) conduct a review of claims for payment under such 
     title with respect to durable medical equipment furnished by 
     such supplier submitted during the 12-month period prior to 
     the date of such determination.''.
                                 ______
                                 
  SA 3693. Ms. MURKOWSKI submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

       In section 1402, strike subsection (a).
                                 ______
                                 
  SA 3694. Mr. GRAHAM submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

       On page 144, between lines 2 and 3, insert the following:

     SEC. 2214. SAVINGS TO FUND FEDERAL PELL GRANTS.

       Notwithstanding any other provision of this Act, the 
     savings resulting from this subtitle that are spent on 
     healthcare under subtitle B shall instead be used to provide 
     additional funding for the Federal Pell Grant program under 
     section 401 of the Higher Education Act of 1965 (20 U.S.C. 
     1070a), in order to address budgetary shortfalls for such 
     program for fiscal years 2010 through 2019.
                                 ______
                                 
  SA 3695. Mr. ALEXANDER submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       On page 143, strike lines 1 through 13 and insert the 
     following:
       ``(7) Interest rate disclosure.--
       ``(A) Provision of assistance.--The Secretary shall provide 
     annual disclosures to student and parent borrowers of student 
     loans under this part on the annual and cumulative difference 
     of the interest rate and amounts owed in interest paid by the 
     student, as compared to the interest rate paid by the 
     Department of Education to the Department of the Treasury.
       ``(B) Funds.--There are authorized to be appropriated, and 
     there are appropriated, to carry out this paragraph (in 
     addition to any other amounts appropriated to carry out this 
     paragraph and out of any money in the Treasury not otherwise 
     appropriated), $5,000,000 for each of the fiscal years 2010 
     through 2019.''.
                                 ______
                                 
  SA 3696. Mr. ENSIGN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       Strike section 1002 and insert the following:

     SEC. 1002. REPEAL OF INDIVIDUAL MANDATE.

       Sections 1501 and 1502 and subsections (a), (b), (c), and 
     (d) of section 10106 of the Patient Protection and Affordable 
     Care Act (and the amendments made by such sections and 
     subsections) are repealed and the Internal Revenue Code of 
     1986 shall be applied and administered as if such provisions 
     and amendments had never been enacted.
                                 ______
                                 
  SA 3697. Mr. BROWNBACK submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of section 1402(a), insert the following:
       (5) Inflation adjustment.--Section 1411 of the Internal 
     Revenue Code of 1986, as added by paragraph (1), is amended 
     by adding at the end the following new subsection:
       ``(f) Adjustment for Inflation.--In the case of any taxable 
     year beginning after December 31, 2013, each of the dollar 
     amounts under paragraphs (1) and (3) of subsection (b), 
     subparagraphs (A) and (C) of section 3101(b)(2), and clauses 
     (i) and (iii) of section

[[Page 4940]]

     1401(b)(2)(A) shall be increased by an amount equal to--
       ``(1) such amount, multiplied by
       ``(2) the cost-of-living adjustment determined under 
     section 1(f)(3) for the calendar year in which such taxable 
     year begins by substituting `calendar year 2012' for 
     `calendar year 1992' in subparagraph (B) thereof.
     If any increase determined under this subsection is not a 
     multiple of $1,000, such increase shall be rounded to the 
     next lowest multiple of $1,000.''.
                                 ______
                                 
  SA 3698. Mr. CORNYN submitted an amendment intended to be proposed by 
him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); which was ordered to lie on the table; as 
follows:

       At the end of subtitle F of title I, insert the following:

     SEC. 1__. LIMITATION ON APPLICATION OF ACTS.

       Notwithstanding any other provision of law, the Secretary 
     of Health and Human Services shall not implement the Patient 
     Protection and Affordable Care Act and the Health Care and 
     Education Reconciliation Act of 2011 until the Office of the 
     Actuary at the Centers for Medicare & Medicaid Services 
     certifies to Congress that such Acts will reduce National 
     health expenditures relative to the level of such 
     expenditures under current law.
                                 ______
                                 
  SA 3699. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill H.R. 4872, to provide for reconciliation pursuant to 
Title II of the concurrent resolution on the budget for fiscal year 
2010 (S. Con. Res. 13); as follows:

       At the end of the bill, insert:

           TITLE III--TEMPORARY EXTENSION OF CERTAIN PROGRAMS

     SEC. 300. SHORT TITLE.

       This title may be cited as the ``Continuing Extension Act 
     of 2010''.

     SEC. 301. EXTENSION OF UNEMPLOYMENT INSURANCE PROVISIONS.

       (a) In General.--(1) Section 4007 of the Supplemental 
     Appropriations Act, 2008 (Public Law 110-252; 26 U.S.C. 3304 
     note) is amended--
       (A) by striking ``April 5, 2010'' each place it appears and 
     inserting ``May 5, 2010'';
       (B) in the heading for subsection (b)(2), by striking 
     ``april 5, 2010'' and inserting ``may 5, 2010''; and
       (C) in subsection (b)(3), by striking ``September 4, 2010'' 
     and inserting ``October 2, 2010''.
       (2) Section 2002(e) of the Assistance for Unemployed 
     Workers and Struggling Families Act, as contained in Public 
     Law 111-5 (26 U.S.C. 3304 note; 123 Stat. 438), is amended--
       (A) in paragraph (1)(B), by striking ``April 5, 2010'' and 
     inserting ``May 5, 2010'';
       (B) in the heading for paragraph (2), by striking ``april 
     5, 2010'' and inserting ``may 5, 2010''; and
       (C) in paragraph (3), by striking ``October 5, 2010'' and 
     inserting ``November 5, 2010''.
       (3) Section 2005 of the Assistance for Unemployed Workers 
     and Struggling Families Act, as contained in Public Law 111-5 
     (26 U.S.C. 3304 note; 123 Stat. 444), is amended--
       (A) by striking ``April 5, 2010'' each place it appears and 
     inserting ``May 5, 2010''; and
       (B) in subsection (c), by striking ``September 4, 2010'' 
     and inserting ``October 2, 2010''.
       (4) Section 5 of the Unemployment Compensation Extension 
     Act of 2008 (Public Law 110-449; 26 U.S.C. 3304 note) is 
     amended by striking ``September 4, 2010'' and inserting 
     ``October 2, 2010''.
       (b) Funding.--Section 4004(e)(1) of the Supplemental 
     Appropriations Act, 2008 (Public Law 110-252; 26 U.S.C. 3304 
     note) is amended--
       (1) in subparagraph (C), by striking ``and'' at the end;
       (2) by inserting after subparagraph (D) the following new 
     subparagraph:
       ``(E) the amendments made by section 2(a)(1) of the 
     Continuing Extension Act of 2010; and''.
       (c) Effective Date.--The amendments made by this section 
     shall take effect as if included in the amendments made by 
     section 2 of the Temporary Extension Act of 2010 (Public Law 
     111-144).

     SEC. 302. EXTENSION AND IMPROVEMENT OF PREMIUM ASSISTANCE FOR 
                   COBRA BENEFITS.

       Subsection (a)(3)(A) of section 3001 of division B of the 
     American Recovery and Reinvestment Act of 2009 (Public Law 
     111-5), as amended by section 3(a) of the Temporary Extension 
     Act of 2010 (Public Law 111-144), is amended by striking 
     ``March 31, 2010'' and inserting ``April 30, 2010''.

     SEC. 303. INCREASE IN THE MEDICARE PHYSICIAN PAYMENT UPDATE.

       Paragraph (10) of section 1848(d) of the Social Security 
     Act, as added by section 1011(a) of the Department of Defense 
     Appropriations Act, 2010 (Public Law 111-118) and as amended 
     by section 5 of the Temporary Extension Act of 2010 (Public 
     Law 111-144), is amended--
       (1) in subparagraph (A), by striking ``March 31, 2010'' and 
     inserting ``April 30, 2010''; and
       (2) in subparagraph (B), by striking ``April 1, 2010'' and 
     inserting ``May 1, 2010''.

     SEC. 304. EHR CLARIFICATION.

       (a) Qualification for Clinic-Based Physicians.--
       (1) Medicare.--Section 1848(o)(1)(C)(ii) of the Social 
     Security Act (42 U.S.C. 1395w-4(o)(1)(C)(ii)) is amended by 
     striking ``setting (whether inpatient or outpatient)'' and 
     inserting ``inpatient or emergency room setting''.
       (2) Medicaid.--Section 1903(t)(3)(D) of the Social Security 
     Act (42 U.S.C. 1396b(t)(3)(D)) is amended by striking 
     ``setting (whether inpatient or outpatient)'' and inserting 
     ``inpatient or emergency room setting''.
       (b) Effective Date.--The amendments made by subsection (a) 
     shall be effective as if included in the enactment of the 
     HITECH Act (included in the American Recovery and 
     Reinvestment Act of 2009 (Public Law 111-5)).
       (c) Implementation.--Notwithstanding any other provision of 
     law, the Secretary of Health and Human Services may implement 
     the amendments made by this section by program instruction or 
     otherwise.

     SEC. 305. ELIMINATION OF A SWEETHEART DEAL THAT INCREASES 
                   MEDICARE REIMBURSEMENT JUST FOR FRONTIER 
                   STATES.

       Effective as if included in the enactment of the Patient 
     Protection and Affordable Care Act, section 10324 of such Act 
     (and the amendments made by such section) is repealed.

     SEC. 306. EXTENSION OF USE OF 2009 POVERTY GUIDELINES.

       Section 1012 of the Department of Defense Appropriations 
     Act, 2010 (Public Law 111-118), as amended by section 7 of 
     the Temporary Extension Act of 2010 (Public Law 111-144), is 
     amended by striking ``March 31, 2010'' and inserting ``April 
     30, 2010''.

     SEC. 307. EXTENSION OF NATIONAL FLOOD INSURANCE PROGRAM.

       (a) Extension.--Section 129 of the Continuing 
     Appropriations Resolution, 2010 (Public Law 111-68), as 
     amended by section 8 of Public Law 111-144, is amended by 
     striking ``by substituting'' and all that follows through the 
     period at the end and inserting ``by substituting April 30, 
     2010, for the date specified in each such section.''.
       (b) Effective Date.--The amendments made by subsection (a) 
     shall be considered to have taken effect on February 28, 
     2010.

     SEC. 308. SATELLITE TELEVISION EXTENSION.

       (a) Amendments to Section 119 of Title 17, United States 
     Code.--
       (1) In general.--Section 119 of title 17, United States 
     Code, is amended--
       (A) in subsection (c)(1)(E), by striking ``March 28, 2010'' 
     and inserting ``April 30, 2010''; and
       (B) in subsection (e), by striking ``March 28, 2010'' and 
     inserting ``April 30, 2010''.
       (2) Termination of license.--Section 1003(a)(2)(A) of 
     Public Law 111-118 is amended by striking ``March 28, 2010'', 
     and inserting ``April 30, 2010''.
       (b) Amendments to Communications Act of 1934.--Section 
     325(b) of the Communications Act of 1934 (47 U.S.C. 325(b)) 
     is amended--
       (1) in paragraph (2)(C), by striking ``March 28, 2010'' and 
     inserting ``April 30, 2010''; and
       (2) in paragraph (3)(C), by striking ``March 29, 2010'' 
     each place it appears in clauses (ii) and (iii) and inserting 
     ``May 1, 2010''.

     SEC. 309. COMPENSATION AND RATIFICATION OF AUTHORITY RELATED 
                   TO LAPSE IN HIGHWAY PROGRAMS.

       (a) Compensation for Federal Employees.--Any Federal 
     employees furloughed as a result of the lapse in expenditure 
     authority from the Highway Trust Fund after 11:59 p.m. on 
     February 28, 2010, through March 2, 2010, shall be 
     compensated for the period of that lapse at their standard 
     rates of compensation, as determined under policies 
     established by the Secretary of Transportation.
       (b) Ratification of Essential Actions.--All actions taken 
     by Federal employees, contractors, and grantees for the 
     purposes of maintaining the essential level of Government 
     operations, services, and activities to protect life and 
     property and to bring about orderly termination of Government 
     functions during the lapse in expenditure authority from the 
     Highway Trust Fund after 11:59 p.m. on February 28, 2010, 
     through March 2, 2010, are hereby ratified and approved if 
     otherwise in accord with the provisions of the Continuing 
     Appropriations Resolution, 2010 (division B of Public Law 
     111-68).
       (c) Funding.--Funds used by the Secretary to compensate 
     employees described in subsection (a) shall be derived from 
     funds previously authorized out of the Highway Trust Fund and 
     made available or limited to the Department of Transportation 
     by the Consolidated Appropriations Act, 2010 (Public Law 111-
     117) and shall be subject to the obligation limitations 
     established in such Act.
       (d) Expenditures From Highway Trust Fund.--To permit 
     expenditures from the Highway Trust Fund to effectuate the 
     purposes of this section, this section shall be deemed to be 
     a section of the Continuing Appropriations Resolution, 2010 
     (division B of Public Law 111-68), as in effect on the date 
     of the enactment of the last amendment to such Resolution.

[[Page 4941]]



     SEC. 310. USE OF STIMULUS FUNDS TO OFFSET SPENDING.

       The unobligated balance of each amount appropriated or made 
     available under the American Recovery and Reinvestment Act of 
     2009 (Public Law 111-5) (other than under title X of division 
     A of such Act) is rescinded pro rata such that the aggregate 
     amount of such rescissions equals $9,200,000,000 in order to 
     offset the net increase in spending resulting from the 
     provisions of, and amendments made by, sections 2 through 10. 
     The Director of the Office of Management and Budget shall 
     report to each congressional committee the amounts so 
     rescinded within the jurisdiction of such committee.

     SEC. 311. ELIMINATION OF ADVANCE REFUNDABILITY OF EARNED 
                   INCOME CREDIT.

       (a) In General.--Section 3507, subsection (g) of section 
     32, and paragraph (7) of section 6051(a) are repealed.
       (b) Conforming Amendments.--
       (1) Section 6012(a) is amended by striking paragraph (8) 
     and by redesignating paragraph (9) as paragraph (8).
       (2) Section 6302 is amended by striking subsection (i).
       (c) Effective Date.--The repeals and amendments made by 
     this section shall apply to taxable years beginning after 
     December 31, 2010.

                          ____________________