[Congressional Record Volume 155, Number 185 (Thursday, December 10, 2009)]
[Senate]
[Pages S12914-S12968]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 3115. Mr. CASEY submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 1609, after line 23, insert the following:

     SEC. 6108. COMMUNITY INTEGRATED NURSING CARE HOMES 
                   DEMONSTRATION PROGRAM.

       (a) Short Title.--This section may be cited as the 
     ``Community Integrated Nursing Care Homes Demonstration 
     Program Act'' or the ``CINCH Demonstration Program''.
       (b) Establishment.--
       (1) In general.--The Secretary shall establish the CINCH 
     demonstration program to test the viability of multiple small 
     house nursing homes that are embedded within residential 
     neighborhoods and collectively certified to provide services 
     through a single eligible operating entity in order to reduce 
     administrative costs and provide related cost savings to the 
     Medicare and Medicaid programs.
       (2) Duration and scope.--
       (A) Duration.--The Secretary shall conduct the CINCH 
     demonstration program for a period of 5 years.
       (B) Scope.--The Secretary shall select not more than 6 
     sites (as described in paragraph (3)) to participate in the 
     CINCH demonstration program, with each site to be operated by 
     a different eligible operating entity (as described under 
     subsection (c)(2)) and not less than 2 sites to be located in 
     rural areas.
       (3) Sites.--
       (A) In general.--A site shall consist of not less than 2 
     locations, with each location containing not more than 2 
     small house nursing homes, that are operated by an eligible 
     operating entity under such entity's nursing home license and 
     provider certification.
       (B) Locations.--
       (i) Distances.--Distances between locations within a site 
     may vary based upon market demand and availability, with 
     maximum distances between locations to be established by the 
     eligible operating entity based upon the ability of such 
     entity to--

       (I) deliver required services and supervision in a timely 
     and appropriate manner; and
       (II) subject to paragraph (5), meet all applicable 
     statutory and regulatory requirements for operation of a 
     nursing home.

       (ii) Adjoining parcels.--A location shall--

       (I) consist of a single parcel of land or multiple 
     adjoining parcels of land; and
       (II) be separate from any other location and operate on a 
     non-adjoining parcel of land from such location.

       (C) Number of small house nursing homes per site.--A site 
     shall contain not less than 4 small house nursing homes and 
     not greater than--
       (i) in rural areas (or a site that encompasses a rural 
     area), 12 small house nursing homes; or
       (ii) in urban or suburban areas, 24 small house nursing 
     homes.
       (4) Continuation of treatment as single provider.--The 
     Secretary shall develop a process to allow a site, following 
     the 5-year period for the CINCH demonstration program, to 
     continue operation through a single operating entity and 
     receive certification as a single provider for purposes of 
     Medicare and Medicaid, including provisions to permit such 
     continuation following a change in ownership of a 
     participating small house nursing home.
       (5) Waiver authority.--The Secretary may waive such 
     requirements of titles XI, XVIII, and XIX of the Social 
     Security Act as may be necessary to carry out the CINCH 
     demonstration program and shall develop a process that 
     permits sites to be certified and reimbursed under Medicare 
     and Medicaid.
       (c) Selection.--
       (1) Technical assistance provider.--
       (A) In general.--Not later than 90 days after the date of 
     enactment of this Act, the Secretary, through a request for 
     proposal process, shall select a technical assistance 
     provider that shall be responsible for assisting and 
     monitoring eligible operating entities (as described under 
     paragraph (2)).
       (B) Minimum requirements.--In selecting the technical 
     assistance provider, the Secretary shall ensure that such 
     organization--
       (i) is a national not-for-profit organization that is in 
     good standing;
       (ii) has a consistent, clearly articulated, and research-
     based model for operation of small house nursing homes;
       (iii) has not less than 10 years of experience in providing 
     development, operation, regulatory, policy, and financial 
     consulting services to clients or partners seeking to 
     innovate the provision of long-term care;
       (iv) has demonstrated a successful process and record (for 
     not less than 4 years) for selection and assistance of 
     multiple organizations in implementation of a small house 
     nursing home model, including development, operations, and 
     staff training;
       (v) has established curricula for training of leadership, 
     clinical, and direct care staff;
       (vi) has demonstrated capacity, through its own resources 
     and consultants, to--

       (I) collect Minimum Data Set (``MDS'') information and 
     financial data from eligible operating entities; and

[[Page S12915]]

       (II) benchmark and analyze such financial data on not less 
     than a quarterly basis;

       (vii) has the ability to administer the CINCH demonstration 
     program without additional funding from Federal, State, or 
     local governmental sources;
       (viii) agrees to provide technical assistance services to 
     eligible operating entities for a fee that is not greater 
     than its usual and customary fee for such services; and
       (ix) agrees to maintain a provider network for small house 
     nursing homes participating in the CINCH demonstration 
     program for a fee that is not greater than its usual and 
     customary fee for such services.
       (C) Preferences.--In selecting the technical assistance 
     provider, the Secretary shall give preference to an 
     organization that has demonstrated experience in related 
     business activities, including community-based care models, 
     health care financing, and demonstration programs.
       (2) Eligible operating entity.--
       (A) In general.--Selection of eligible operating entities 
     shall be determined by the technical assistance provider 
     through a request for proposal process on a continual basis.
       (B) Minimum requirements.--An eligible operating entity 
     seeking to participate in the CINCH demonstration program 
     shall be required to--
       (i) commit to maintaining the small house nursing home 
     requirements described under subsection (d) and permit the 
     technical assistance provider to conduct periodic evaluations 
     to ensure adherence to such requirements;
       (ii) maintain membership in a small house nursing home 
     provider network that is maintained by the technical 
     assistance provider; and
       (iii) ensure that, for each site, at least 30 percent of 
     the total capacity developed under the CINCH demonstration 
     program is provided to residents that are receiving nursing 
     home benefits under Medicaid.
       (d) Small House Nursing Home Requirements.--To be eligible 
     to participate in the CINCH demonstration program, a small 
     house nursing home shall--
       (1) subject to subsection (b)(5), have been certified by a 
     State or local entity (in accordance with applicable State 
     and local law) to operate a nursing home;
       (2) operate in compliance with any direct care and 
     certified nurse assistant staffing requirements under Federal 
     and State law;
       (3) provide nursing home services, as required under State 
     law and applicable licensing standards, that shall not be 
     less comprehensive or high-acuity than services provided by 
     the eligible operating entity within the immediate 
     surrounding community;
       (4) provide for meals cooked in the small house nursing 
     home and not prepared in a central kitchen and transported to 
     the nursing home;
       (5) provide for a universal worker approach to resident 
     care (such as a certified nursing assistant who provides 
     personal care, socialization services, meal preparation 
     services, and laundry and housekeeping services);
       (6) provide for direct care staffing at a rate of not less 
     than 4 hours per resident per day, with direct care staff 
     (including certified nurse assistants) to be onsite, awake, 
     and available within each nursing home at all times;
       (7) provide for direct nursing care at a rate of not less 
     than 1 hour per resident per day, with a nurse to be awake 
     and available at each location at all times (with nurses to 
     be shared between not more than 2 nursing homes on each site) 
     as part of a nursing staff that meets or exceeds applicable 
     Federal and State requirements for qualifications, services, 
     and availability;
       (8) provide for any other clinical, operational, 
     management, or facility staff and services as required under 
     applicable Federal and State requirements, with such staff to 
     be available from centralized or distributed locations;
       (9) provide for consistent staff assignments and self-
     directed work teams of direct care staff;
       (10) provide training for all staff involved in the 
     operations of the nursing home (for not less than 120 hours 
     for each universal worker and not less than 60 hours for each 
     leadership and clinical team member, to be completed for the 
     majority of the staff before they start to work in a small 
     house nursing home) concerning the philosophy, operations, 
     and skills required to implement and maintain self-directed 
     care, self-managed work teams, a noninstitutional approach to 
     life and care in long-term care, appropriate safety and 
     emergency skills, cooking from scratch by the direct care 
     staff and food handling and safety, and other elements 
     required for successful operation of the nursing home;
       (11) ensure that the percentage of residents in each 
     nursing home who are short-stay rehabilitation residents does 
     not exceed 20 percent at any time (unless the small house 
     nursing home is entirely devoted to providing rehabilitation 
     services), except that a long-term resident transferring back 
     to a nursing home after an acute episode and who is receiving 
     rehabilitation services for which payment is made under the 
     Medicare program shall not be counted toward such limitation;
       (12) provide the technical assistance provider with MDS 
     information and financial data in a timely manner on a 
     monthly basis; and
       (13) consist of a physical environment designed to look and 
     feel like a home, rather than an institution, and that 
     shall--
       (A) be designed to serve as a fully independent and 
     disabled accessible house or apartment, with not more than 10 
     residents within such house or apartment, and that shall only 
     be connected to or share areas that would be generally shared 
     between private homes (such as a driveway) or apartments 
     (such as a lobby or laundry room);
       (B) contain residential-style design elements and materials 
     throughout the home that are similar to those in the 
     immediate surrounding community and that do not use 
     commercial and institutional elements and products (such as a 
     nurses' station, medication carts, hospital or office-type 
     florescent lighting, acoustical tile ceilings, institutional-
     style railings and corner guards, and room numbering and 
     labeling) unless mandated by authorities with appropriate 
     jurisdiction over the nursing home;
       (C) provide private, single occupancy bedrooms that are 
     shared only at the request of a resident to accommodate a 
     spouse, partner, family member, or friend, and that contains 
     a full private bathroom that includes, at a minimum, a 
     toilet, sink, and accessible shower;
       (D) contain a living area where residents and staff may 
     socialize, dine, and prepare food together that provides, at 
     a minimum, a living room seating area, a dining area large 
     enough for a single table serving all residents and not less 
     than 2 staff members, and an open full kitchen;
       (E) contain ample natural light in each habitable space 
     that is provided through exterior windows and other means, 
     with window areas, exclusive of skylights and clerestories, 
     being a minimum of 10 percent of the area of the room;
       (F) have a life-safety rating that is sufficient to meet 
     State and local standards for nursing facilities and 
     appropriately accommodate individuals who cannot evacuate the 
     nursing home without assistance; and
       (G) contain built-in safety features to allow all areas of 
     the nursing home to be accessible to residents during the 
     majority of the day and night.
       (e) No Additional Payment.--The technical assistance 
     provider, as well as any eligible operating entities and 
     participating small house nursing homes, shall not receive 
     any additional payment or reimbursement under the Medicare or 
     Medicaid programs based upon their participation in the CINCH 
     demonstration program.
       (f) Evaluation and Report.--
       (1) In general.--Not later than 4 years after the date of 
     enactment of this Act, the technical assistance provider 
     shall evaluate the performance of each of the sites 
     participating under the CINCH demonstration program and shall 
     submit to Congress and the Secretary a report containing the 
     results of such evaluation.
       (2) Evaluation requirements.--The evaluation shall include 
     an analysis of--
       (A) not less than 12 months of MDS information and 
     financial data from at least 10 small house nursing homes; 
     and
       (B) results from focus groups or surveys regarding health 
     outcomes for residents and program costs.
       (g) Definitions.--In this section:
       (1) CINCH demonstration program.--The term ``CINCH 
     demonstration program'' means the demonstration program 
     conducted under this section.
       (2) Medicaid.--The term ``Medicaid'' means the program for 
     medical assistance established under title XIX of the Social 
     Security Act (42 U.S.C. 1396 et seq.).
       (3) Medicare.--The term ``Medicare'' means the program for 
     medical assistance established under title XVIII of the 
     Social Security Act (42 U.S.C. 1395 et seq.).
       (4) Nursing home.--The term ``nursing home'' means--
       (A) a skilled nursing facility (as defined in section 
     1819(a) of the Social Security Act (42 U.S.C. 1395i-3(a))); 
     or
       (B) a nursing facility (as defined in section 1919(a) of 
     the Social Security Act (42 U.S.C. 1396r(a))).
       (5) Research-based.--The term ``research-based'' means 
     research that--
       (A) has been conducted by an objective researcher or 
     research team that has--
       (i) no financial or affiliated organizational interest in 
     the success of the model; and
       (ii) expertise in long-term care, with not less than 3 
     research articles relating to long-term care that have been 
     published in leading peer-reviewed journals;
       (B) has been conducted according to generally accepted 
     research practices;
       (C) has been published in a leading peer-reviewed journal 
     on aging or long-term care; and
       (D) indicates a measurable improvement in multiple aspects 
     of quality of life and care.
       (6) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.
       (7) Rural area.--The term ``rural area'' means any area 
     other than an urban or suburban area.
       (8) Suburban area.--The term ``suburban area'' means any 
     urbanized area that is contiguous and adjacent to an urban 
     area.
       (9) Urban area.--The term ``urban area'' means a city or 
     town that has a population of greater than 50,000 
     inhabitants.
                                 ______
                                 
  SA 3116. Mr. WYDEN (for himself, Ms. Collins, and Mr. Bayh) submitted 
an amendment intended to be proposed to amendment SA 2786 proposed by 
Mr. Reid (for himself, Mr. Baucus, Mr.

[[Page S12916]]

Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 2028, strike lines 9 and 10 and insert the 
     following:
       (3) Efficiency adjustment based on premium increases.--
       (A) In general.--The portion of the fee determined under 
     paragraph (1) with respect to a covered entity for a calendar 
     year which is attributable to net premiums written shall be 
     multiplied by an amount equal to the sum of--
       (i) 50 percent, plus
       (ii) the applicable percentage.
       (B) Applicable percentage.--The applicable percentage is a 
     percentage determined by the Secretary in the following 
     manner:
       (i) The applicable percentage for the covered entity with 
     the lowest per-capita premium change shall be 0 percent.
       (ii) The applicable percentage for the covered entity with 
     the highest per-capita premium change shall be 100 percent.
       (iii) The applicable percentage for each other cover entity 
     shall be based on the degree to which the per-capita premium 
     change for such covered entity is greater than the covered 
     entity with the lowest per-capita premium change, except that 
     in determining such amount the Secretary shall ensure that 
     the aggregate fees for all covered entities under this 
     section for the calendar year (after application of this 
     subsection) is equal to $6,700,000,000.
       (iv) Notwithstanding clause (iii), the Secretary may reduce 
     the applicable percentage for a covered entity (but not below 
     zero) with respect to any calendar year if the Secretary 
     determines that the amount of the per-capita premium increase 
     for such entity was primarily due to government restrictions 
     on rates, but only to the extent that the amount of the per-
     capita premium increase was due to such government 
     restrictions, as determined by the Secretary. In the case of 
     any reduction under the preceding sentence, proper adjustment 
     shall be made to the applicable percentages for other covered 
     entities described in clause (iii) such that the aggregate 
     fees for all covered entities under this section for the 
     calendar year (after application of this subsection) is equal 
     to $6,700,000,000. In no case shall any adjustment cause the 
     applicable percentage for any covered entity to exceed 100 
     percent.
       (C) Per-capita premium change.--For purposes of this 
     paragraph--
       (i) In general.--The term ``per-capita premium change'' 
     means, with respect to any calendar year, the excess of--

       (I) the per-capita premium amount for the such calendar 
     year, over
       (II) the per capita premium amount for the preceding 
     calendar year.

       (ii) Per-capita premium amount.--The term ``per-capita 
     premium amount'' means, with respect to any calendar year, 
     the total amount of net premiums written with respect to 
     health insurance for any United States health risk for such 
     calendar year divided by the number of United States health 
     risks which are covered under such net written premiums.
       (iii) Reporting.--

       (I) In general.--Each covered entity shall include in the 
     report required under subsection (g) the number of United 
     States health risks which are covered under net written 
     premiums with respect to health insurance.
       (II) Penalty.--The rules of subsection (g)(2) shall apply 
     to the information required to be reported under subclause 
     (I).

       (4) Secretarial determination.--The Secretary shall 
     calculate the amount of each covered entity's fee for any 
     calendar year under this subsection.
                                 ______
                                 
  SA 3117. Mr. WYDEN (for himself, Ms. Collins, and Mr. Bayh) submitted 
an amendment intended to be proposed to amendment SA 2786 proposed by 
Mr. Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the 
bill H.R. 3590, to amend the Internal Revenue Code of 1986 to modify 
the first-time homebuyers credit in the case of members of the Armed 
Forces and certain other Federal employees, and for other purposes; 
which was ordered to lie on the table; as follows:

       On page 164, between lines 2 and 3, insert the following:

     SEC. 13__. OPTIONAL FREE CHOICE VOUCHERS.

       (a) In General.--Any employer may provide a free choice 
     voucher to any employee of such employer, but only if such 
     employer offers free choice vouchers to--
       (1) in the case of an offering employer, all employees of 
     such employer who are eligible to participate in an employer-
     sponsored plan described in subsection (c)(1), and
       (2) in the case of any other employer, all employees of the 
     employer.
       (b) Free Choice Voucher.--
       (1) Amount.--
       (A) Offering employers.--
       (i) In general.--In the case of an offering employer, the 
     amount of the free choice voucher provided under subsection 
     (a) shall be equal to the monthly portion of the cost of the 
     eligible employer-sponsored plan which would have been paid 
     by the employer if the employee were covered under the plan 
     with respect to which the employer pays the largest portion 
     of the employee's premium. Such amount shall be equal to the 
     amount the employer would pay for an employee with self-only 
     coverage unless such employee elects family coverage (in 
     which case such amount shall be the amount the employer would 
     pay for family coverage).
       (ii) Determination of cost.--The cost of any health plan 
     shall be determined under the rules similar to the rules of 
     section 2204 of the Public Health Service Act, except that 
     such amount may be adjusted for age and category of coverage 
     in accordance with regulations established by the Secretary.
       (B) Other employers.--In the case of any other employer, 
     the amount of the voucher provided under subsection (a) shall 
     be not greater than the amount equal to the lowest cost 
     bronze plan of the individual market in the rating area in 
     which the employee resides which--
       (i) is offered through an Exchange, and
       (ii) provides--

       (I) in the case of an employee electing self-only coverage, 
     self-only coverage, and
       (II) in any other case, family coverage.

       (2) Use of vouchers.--An Exchange shall credit the amount 
     of any free choice voucher provided under subsection (a) to 
     the monthly premium of any qualified health plan in the 
     Exchange in which the qualified employee is enrolled and the 
     offering employer shall pay any amounts so credited to the 
     Exchange.
       (3) Payment of excess amounts.--If the amount of the free 
     choice voucher exceeds the amount of the premium of the 
     qualified health plan in which the qualified employee is 
     enrolled for such month, such excess shall be paid to the 
     employee. Any amount paid to the employee under the preceding 
     sentence shall not be taken into account in determining the 
     rate of pay of the employee under the Fair Labor Standards 
     Act of 1938.
       (c) Offering Employer.--For purposes of this section, the 
     term ``offering employer'' means any employer who--
       (1) offers minimum essential coverage to its employees 
     consisting of coverage through an eligible employer-sponsored 
     plan; and
       (2) pays any portion of the costs of such plan.
       (d) Other Definitions.--Any term used in this section which 
     is also used in section 5000A of the Internal Revenue Code of 
     1986 shall have the meaning given such term under such 
     section 5000A.
       (e) Accelerated Access to Exchanges.--Notwithstanding 
     section 1312(f)(2)(B)--
       (1) beginning in 2015, each State may allow issuers of 
     health insurance coverage in the large group market in the 
     State to offer qualified health plans in such market through 
     an Exchange, but only in connection with employers who 
     provide free choice vouchers under subsection (a); and
       (2) if a State under paragraph (1) allows issuers to offer 
     qualified plans in the large group market though an Exchange, 
     the term ``qualified employer'' (as defined in section 
     1312(f)(2)) shall include a large employer that--
       (A) provides free choice vouchers to its employees under 
     subsection (a); and
       (B) elects to make all full-time employees eligible for 1 
     or more qualified health plans offered in the large group 
     market through the Exchange.
       (f) Exclusion From Income for Employee.--
       (1) In general.--Part III of subchapter B of chapter 1 of 
     the Internal Revenue Code of 1986 is amended by inserting 
     after section 139C the following new section:

     ``SEC. 139D. FREE CHOICE VOUCHERS.

       ``Gross income shall not include the amount of any free 
     choice voucher provided by an employer under part I of 
     subtitle D of title I of the Patient Protection and 
     Affordable Care Act to the extent that the amount of such 
     voucher does not exceed the amount paid for a qualified 
     health plan (as defined in section 1301 of such Act) by the 
     taxpayer.''.
       (2) Clerical amendment.--The table of sections for part III 
     of subchapter B of chapter 1 of such Code is amended by 
     inserting after the item relating to section 139C the 
     following new item:

``Sec. 139D. Free choice vouchers.''.

       (3) Effective date.--The amendments made by this subsection 
     shall apply to vouchers provided after December 31, 2013.
       (g) Deduction Allowed to Employer.--
       (1) In general.--Section 162(a) of the Internal Revenue 
     Code of 1986 is amended by adding at the end the following 
     new sentence: ``For purposes of paragraph (1), the amount of 
     a free choice voucher provided under part I of subtitle D of 
     title I of the Patient Protection and Affordable Care Act 
     shall be treated as an amount for compensation for personal 
     services actually rendered.''.
       (2) Effective date.--The amendments made by this subsection 
     shall apply to vouchers provided after December 31, 2013.
       (h) Voucher Taken Into Account in Determining Premium 
     Credit.--
       (1) In general.--Subsection (b)(2) of section 36B of the 
     Internal Revenue Code of 1986, as added by section 1401, is 
     amended by adding at the end the following new flush 
     sentence:
     ``The amount of any monthly premium under subsection 
     subparagraph (A) and the amount of the adjusted monthly 
     premium for the second lowest cost silver plan under 
     subparagraph (B) shall be reduced by the amount of any free 
     choice voucher provided to the taxpayer under section ___ of 
     the Patient Protection and Affordable Care Act.''.

[[Page S12917]]

       (2) Effective date.--The amendment made by this subsection 
     shall apply to taxable years beginning after December 31, 
     2013.
       (i) Coordination With Employer Responsibilities.--
       (1) Shared responsibility penalty.--
       (A) In general.--Subsection (c) of section 4980H of the 
     Internal Revenue Code of 1986, as added by section 1513, is 
     amended by adding at the end the following new paragraph:
       ``(3) Special rules for employers providing free choice 
     vouchers.--The assessable payment imposed under paragraph (1) 
     shall be reduced (but not below zero) by the amount of any 
     free choice voucher provided to a full-time employee under 
     section __ of the Patient Protection and Affordable Care Act 
     for any month during which such employee is enrolled in a 
     qualified health plan with respect to which an applicable 
     premium credit or cost-sharing subsidy is allowed or paid 
     with respect to such employee.''.
       (B) Effective date.--The amendment made by this paragraph 
     shall apply to months beginning after December 31, 2013.
       (2) Notification requirement.--Section 18B(a)(3) of the 
     Fair Labor Standards Act of 1938, as added by section 1512, 
     is amended--
       (A) by inserting ``and the employer does not offer a free 
     choice voucher'' after ``Exchange''; and
       (B) by striking ``will lose'' and inserting ``may lose''.
                                 ______
                                 
  SA 3118. Ms. COLLINS (for herself, Mr. Wyden, and Mr. Bayh) submitted 
an amendment intended to be proposed to amendment SA 2786 proposed by 
Mr. Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the 
bill H.R. 3590, to amend the Internal Revenue Code of 1986 to modify 
the first-time homebuyers credit in the case of members of the Armed 
Forces and certain other Federal employees, and for other purposes; 
which was ordered to lie on the table; as follows:

       On page 116, between lines 2 and 3, insert the following:
       (3) Special rule for individuals age 30 and over not 
     eligible for exchange credits and reductions.--
       (A) In general.--Subject to subparagraph (B), an individual 
     who has attained at least the age of 30 before the beginning 
     of a plan year shall be treated as an individual described in 
     paragraph (2) if the individual is not eligible for the plan 
     year for the premium tax credit under section 36B of the 
     Internal Revenue Code of 1986 or the cost-sharing reductions 
     under section 1402 with respect to enrollment in a qualified 
     health plan offered through an Exchange. The preceding 
     sentence shall not apply to an individual if the individual 
     is not eligible for such credit or reductions because the 
     individual is eligible to enroll in minimum essential 
     coverage consisting of coverage under a government sponsored 
     program described in section 5000A(f)(1)(A).
       (B) Requirements.--Subparagraph (A) shall only apply to an 
     individual if the individual elects the application of this 
     paragraph and such election provides that--
       (i) the individual acknowledges that coverage under the 
     catastrophic plan is the lowest coverage available, that the 
     plan provides no benefits for any plan year until the 
     individual has incurred cost-sharing expenses in an amount 
     equal to the annual limitation in effect under subsection 
     (c)(1) for the plan year (except as provided for in section 
     2713), and that these cost-sharing expenses could involve 
     significant financial risk for the individual; and
       (ii) the individual agrees that--

       (I) the individual will not change such coverage until the 
     next applicable annual or special enrollment period under 
     section 1311(c)(5); and
       (II) if the individual elects to change such coverage at 
     the time of such enrollment period, the individual may only 
     enroll in the bronze level of coverage.

       (4) State authority.--In accordance with section 1321(d), a 
     State may impose additional requirements or conditions for 
     catastrophic plans described in this subsection to the extent 
     such requirements or conditions are not inconsistent with the 
     requirements under this subsection.
                                 ______
                                 
  SA 3119. Mr. WARNER (for himself, Mr. Udall of Colorado, Mr. Udall of 
New Mexico, Mrs. Shaheen, Mrs. Hagan, Mr. Merkley, Mr. Begich, Mr. 
Burris, Mr. Kaufman, Mr. Bennet, Mrs. Gillibrand, Mr. Franken, Mr. 
Kirk, Ms. Collins, Ms. Klobuchar, and Mr. Whitehouse) submitted an 
amendment intended to be proposed to amendment SA 2786 proposed by Mr. 
Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the bill 
H.R. 3590, to amend the Internal Revenue Code of 1986 to modify the 
first-time homebuyers credit in the case of members of the Armed Forces 
and certain other Federal employees, and for other purposes; which was 
ordered to lie on the table; as follows:

       On page 1134, strike line 3 and insert the following:
     title).

          Subtitle G--Modernizing America's Health Care System

   PART I--IMPROVING QUALITY AND VALUE THROUGH DELIVERY SYSTEM REFORM

     SEC. 3601. QUALITY REPORTING FOR PSYCHIATRIC HOSPITALS.

       (a) In General.--Section 1886(s) of the Social Security 
     Act, as added by section 3401(f), is amended by adding at the 
     end the following new paragraph:
       ``(4) Quality reporting.--
       ``(A) Reduction in update for failure to report.--
       ``(i) In general.--Under the system described in paragraph 
     (1), for rate year 2014 and each subsequent rate year, in the 
     case of a psychiatric hospital or psychiatric unit that does 
     not submit data to the Secretary in accordance with 
     subparagraph (C) with respect to such a rate year, any annual 
     update to a standard Federal rate for discharges for the 
     hospital during the rate year, and after application of 
     paragraph (2), shall be reduced by 2 percentage points.
       ``(ii) Special rule.--The application of this subparagraph 
     may result in such annual update being less than 0.0 for a 
     rate year, and may result in payment rates under the system 
     described in paragraph (1) for a rate year being less than 
     such payment rates for the preceding rate year.
       ``(B) Noncumulative application.--Any reduction under 
     subparagraph (A) shall apply only with respect to the rate 
     year involved and the Secretary shall not take into account 
     such reduction in computing the payment amount under the 
     system described in paragraph (1) for a subsequent rate year.
       ``(C) Submission of quality data.--For rate year 2014 and 
     each subsequent rate year, each psychiatric hospital and 
     psychiatric unit shall submit to the Secretary data on 
     quality measures specified under subparagraph (D). Such data 
     shall be submitted in a form and manner, and at a time, 
     specified by the Secretary for purposes of this subparagraph.
       ``(D) Quality measures.--
       ``(i) In general.--Subject to clause (ii), any measure 
     specified by the Secretary under this subparagraph must have 
     been endorsed by the entity with a contract under section 
     1890(a).
       ``(ii) Exception.--In the case of a specified area or 
     medical topic determined appropriate by the Secretary for 
     which a feasible and practical measure has not been endorsed 
     by the entity with a contract under section 1890(a), the 
     Secretary may specify a measure that is not so endorsed as 
     long as due consideration is given to measures that have been 
     endorsed or adopted by a consensus organization identified by 
     the Secretary.
       ``(iii) Time frame.--Not later than October 1, 2012, the 
     Secretary shall publish the measures selected under this 
     subparagraph that will be applicable with respect to rate 
     year 2014.
       ``(E) Public availability of data submitted.--The Secretary 
     shall establish procedures for making data submitted under 
     subparagraph (C) available to the public. Such procedures 
     shall ensure that a psychiatric hospital and a psychiatric 
     unit has the opportunity to review the data that is to be 
     made public with respect to the hospital or unit prior to 
     such data being made public. The Secretary shall report 
     quality measures that relate to services furnished in 
     inpatient settings in psychiatric hospitals and psychiatric 
     units on the Internet website of the Centers for Medicare & 
     Medicaid Services.''.
       (b) Conforming Amendment.--Section 1890(b)(7)(B)(i)(I) of 
     the Social Security Act, as added by section 3014, is amended 
     by inserting ``1886(s)(4)(D),'' after ``1886(o)(2),''.

     SEC. 3602. PILOT TESTING PAY-FOR-PERFORMANCE PROGRAMS FOR 
                   CERTAIN MEDICARE PROVIDERS.

       (a) In General.--Not later than January 1, 2016, the 
     Secretary of Health and Human Services (in this section 
     referred to as the ``Secretary'') shall, for each provider 
     described in subsection (b), conduct a separate pilot program 
     under title XVIII of the Social Security Act to test the 
     implementation of a value-based purchasing program for 
     payments under such title for the provider.
       (b) Providers Described.--The providers described in this 
     paragraph are the following:
       (1) Psychiatric hospitals (as described in clause (i) of 
     section 1886(d)(1)(B) of such Act (42 U.S.C. 
     1395ww(d)(1)(B))) and psychiatric units (as described in the 
     matter following clause (v) of such section).
       (2) Long-term care hospitals (as described in clause (iv) 
     of such section).
       (3) Rehabilitation hospitals (as described in clause (ii) 
     of such section).
       (4) PPS-exempt cancer hospitals (as described in clause (v) 
     of such section).
       (5) Hospice programs (as defined in section 1861(dd)(2) of 
     such Act (42 U.S.C. 1395x(dd)(2))).
       (c) Waiver Authority.--The Secretary may waive such 
     requirements of titles XI and XVIII of the Social Security 
     Act as may be necessary solely for purposes of carrying out 
     the pilot programs under this section.
       (d) No Additional Program Expenditures.--Payments under 
     this section under the separate pilot program for value based 
     purchasing (as described in subsection (a)) for each provider 
     type described in paragraphs (1) through (5) of subsection 
     (b) for applicable items and services under title XVIII of 
     the Social Security Act for a year shall be established in a 
     manner that does not result in spending more under each such 
     value based purchasing program for such year than would 
     otherwise be expended for such provider type for such year if 
     the pilot program were not implemented, as estimated by the 
     Secretary.

[[Page S12918]]

       (e) Expansion of Pilot Program.--The Secretary may, at any 
     point after January 1, 2018, expand the duration and scope of 
     a pilot program conducted under this subsection, to the 
     extent determined appropriate by the Secretary, if--
       (1) the Secretary determines that such expansion is 
     expected to--
       (A) reduce spending under title XVIII of the Social 
     Security Act without reducing the quality of care; or
       (B) improve the quality of care and reduce spending;
       (2) the Chief Actuary of the Centers for Medicare & 
     Medicaid Services certifies that such expansion would reduce 
     program spending under such title XVIII; and
       (3) the Secretary determines that such expansion would not 
     deny or limit the coverage or provision of benefits under 
     such title XIII for Medicare beneficiaries.

     SEC. 3603. PLANS FOR A VALUE-BASED PURCHASING PROGRAM FOR 
                   AMBULATORY SURGICAL CENTERS.

       Section 3006 of this Act is amended by adding at the end 
     the following new subsection:
       ``(f) Ambulatory Surgical Centers.--
       ``(1) In general.--The Secretary shall develop a plan to 
     implement a value-based purchasing program for payments under 
     the Medicare program under title XVIII of the Social Security 
     Act for ambulatory surgical centers (as described in section 
     1833(i) of the Social Security Act (42 U.S.C. 1395l(i))).
       ``(2) Details.--In developing the plan under paragraph (1), 
     the Secretary shall consider the following issues:
       ``(A) The ongoing development, selection, and modification 
     process for measures (including under section 1890 of the 
     Social Security Act (42 U.S.C. 1395aaa) and section 1890A of 
     such Act, as added by section 3014), to the extent feasible 
     and practicable, of all dimensions of quality and efficiency 
     in ambulatory surgical centers.
       ``(B) The reporting, collection, and validation of quality 
     data.
       ``(C) The structure of value-based payment adjustments, 
     including the determination of thresholds or improvements in 
     quality that would substantiate a payment adjustment, the 
     size of such payments, and the sources of funding for the 
     value-based bonus payments.
       ``(D) Methods for the public disclosure of information on 
     the performance of ambulatory surgical centers.
       ``(E) Any other issues determined appropriate by the 
     Secretary.
       ``(3) Consultation.--In developing the plan under paragraph 
     (1), the Secretary shall--
       ``(A) consult with relevant affected parties; and
       ``(B) consider experience with such demonstrations that the 
     Secretary determines are relevant to the value-based 
     purchasing program described in paragraph (1).
       ``(4) Report to congress.--Not later than January 1, 2011, 
     the Secretary shall submit to Congress a report containing 
     the plan developed under paragraph (1).''.

     SEC. 3604. REVISIONS TO NATIONAL PILOT PROGRAM ON PAYMENT 
                   BUNDLING.

       Section 1866D of the Social Security Act, as added by 
     section 3023, is amended--
       (1) in paragraph (a)(2)(B), in the matter preceding clause 
     (i), by striking ``8 conditions'' and inserting ``10 
     conditions'';
       (2) by striking subsection (c)(1)(B) and inserting the 
     following:
       ``(B) Expansion.--The Secretary may, at any point after 
     January 1, 2016, expand the duration and scope of the pilot 
     program, to the extent determined appropriate by the 
     Secretary, if--
       ``(i) the Secretary determines that such expansion is 
     expected to--

       ``(I) reduce spending under title XVIII of the Social 
     Security Act without reducing the quality of care; or
       ``(II) improve the quality of care and reduce spending;

       ``(ii) the Chief Actuary of the Centers for Medicare & 
     Medicaid Services certifies that such expansion would reduce 
     program spending under such title XVIII; and
       ``(iii) the Secretary determines that such expansion would 
     not deny or limit the coverage or provision of benefits under 
     this title for individuals.''; and
       (3) by striking subsection (g).

     SEC. 3605. IMPROVEMENTS TO THE MEDICARE SHARED SAVINGS 
                   PROGRAM.

       Section 1899 of the Social Security Act, as added by 
     section 3022, is amended by adding at the end the following 
     new subsections:
       ``(i) Option To Use Other Payment Models.--
       ``(1) In general.--If the Secretary determines appropriate, 
     the Secretary may use any of the payment models described in 
     paragraph (2) or (3) for making payments under the program 
     rather than the payment model described in subsection (d).
       ``(2) Partial capitation model.--
       ``(A) In general.--Subject to subparagraph (B), a model 
     described in this paragraph is a partial capitation model in 
     which an ACO is at financial risk for some, but not all, of 
     the items and services covered under parts A and B, such as 
     at risk for some or all physicians' services or all items and 
     services under part B. The Secretary may limit a partial 
     capitation model to ACOs that are highly integrated systems 
     of care and to ACOs capable of bearing risk, as determined to 
     be appropriate by the Secretary.
       ``(B) No additional program expenditures.--Payments to an 
     ACO for items and services under this title for beneficiaries 
     for a year under the partial capitation model shall be 
     established in a manner that does not result in spending more 
     for such ACO for such beneficiaries than would otherwise be 
     expended for such ACO for such beneficiaries for such year if 
     the model were not implemented, as estimated by the 
     Secretary.
       ``(3) Other payment models.--
       ``(A) In general.--Subject to subparagraph (B), a model 
     described in this paragraph is any payment model that the 
     Secretary determines will improve the quality and efficiency 
     of items and services furnished under this title.
       ``(B) No additional program expenditures.--Subparagraph (B) 
     of paragraph (2) shall apply to a payment model under 
     subparagraph (A) in a similar manner as such subparagraph (B) 
     applies to the payment model under paragraph (2).
       ``(j) Involvement in Private Payer and Other Third Party 
     Arrangements.--The Secretary may give preference to ACOs who 
     are participating in similar arrangements with other payers.
       ``(k) Treatment of Physician Group Practice 
     Demonstration.--During the period beginning on the date of 
     the enactment of this section and ending on the date the 
     program is established, the Secretary may enter into an 
     agreement with an ACO under the demonstration under section 
     1866A, subject to rebasing and other modifications deemed 
     appropriate by the Secretary.''.

     SEC. 3606. INCENTIVES TO IMPLEMENT ACTIVITIES TO REDUCE 
                   DISPARITIES.

       Section 1311(g)(1) of this Act is amended--
       (1) in subparagraph (C), by striking ``; and'' and 
     inserting a semicolon;
       (2) in subparagraph (D), by striking the period and 
     inserting ``; and''; and
       (3) by adding at the end the following:
       ``(E) the implementation of activities to reduce health and 
     health care disparities, including through the use of 
     language services, community outreach, and cultural 
     competency trainings.''.

     SEC. 3607. NATIONAL DIABETES PREVENTION PROGRAM.

       Part P of title III of the Public Health Service Act 42 
     U.S.C. 280g et seq.), as amended by section 5405, is amended 
     by adding at the end the following:

     ``SEC. 399V-2. NATIONAL DIABETES PREVENTION PROGRAM.

       ``(a) In General.--The Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention, 
     shall establish a national diabetes prevention program 
     (referred to in this section as the `program') targeted at 
     adults at high risk for diabetes in order to eliminate the 
     preventable burden of diabetes.
       ``(b) Program Activities.--The program described in 
     subsection (a) shall include--
       ``(1) a grant program for community-based diabetes 
     prevention program model sites;
       ``(2) a program within the Centers for Disease Control and 
     Prevention to determine eligibility of entities to deliver 
     community-based diabetes prevention services;
       ``(3) a training and outreach program for lifestyle 
     intervention instructors; and
       ``(4) evaluation, monitoring and technical assistance, and 
     applied research carried out by the Centers for Disease 
     Control and Prevention.
       ``(c) Eligible Entities.--To be eligible for a grant under 
     subsection (b)(1), an entity shall be a State or local health 
     department, a tribal organization, a national network of 
     community-based non-profits focused on health and wellbeing, 
     an academic institution, or other entity, as the Secretary 
     determines.
       ``(d) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated such sums as may be necessary for each of fiscal 
     years 2010 through 2014.''.

     SEC. 3608. SELECTION OF EFFICIENCY MEASURES.

       Sections 1890(b)(7) and 1890A of the Social Security Act, 
     as added by section 3014, are amended by striking ``quality'' 
     each place it appears and inserting ``quality and 
     efficiency''.

     SEC. 3609. REGIONAL TESTING OF PAYMENT AND SERVICE DELIVERY 
                   MODELS UNDER THE CENTER FOR MEDICARE AND 
                   MEDICAID INNOVATION.

       Section 1115A(a) of the Social Security Act, as added by 
     section 3021, is amended by inserting at the end the 
     following new paragraph:
       ``(5) Testing within certain geographic areas.--For 
     purposes of testing payment and service delivery models under 
     this section, the Secretary may elect to limit testing of a 
     model to certain geographic areas.''.

     SEC. 3610. ADDITIONAL IMPROVEMENTS UNDER THE CENTER FOR 
                   MEDICARE AND MEDICAID INNOVATION.

       Section 1115A(a) of the Social Security Act, as added by 
     section 3021, is amended--
       (1) in subsection (b)(2)--
       (A) in subparagraph (A)--
       (i) in the second sentence, by striking ``the preceding 
     sentence may include'' and inserting ``this subparagraph may 
     include, but are not limited to,''; and
       (ii) by inserting after the first sentence the following 
     new sentence: ``The Secretary shall focus on models expected 
     to reduce program costs under the applicable title while 
     preserving or enhancing the quality of care received by 
     individuals receiving benefits under such title.''; and
       (B) in subparagraph (C), by adding at the end the following 
     new clause:
       ``(viii) Whether the model demonstrates effective linkage 
     with other public sector or private sector payers.'';

[[Page S12919]]

       (2) in subsection (b)(4), by adding at the end the 
     following new subparagraph:
       ``(C) Measure selection.--To the extent feasible, the 
     Secretary shall select measures under this paragraph that 
     reflect national priorities for quality improvement and 
     patient-centered care consistent with the measures described 
     in 1890(b)(7)(B).''; and
       (3) in subsection (c)--
       (A) in paragraph (1)(B), by striking ``care and reduce 
     spending; and'' and inserting ``patient care without 
     increasing spending;'';
       (B) in paragraph (2), by striking ``reduce program spending 
     under applicable titles.'' and inserting ``reduce (or would 
     not result in any increase in) net program spending under 
     applicable titles; and''; and
       (C) by adding at the end the following:
       ``(3) the Secretary determines that such expansion would 
     not deny or limit the coverage or provision of benefits under 
     the applicable title for applicable individuals.
     In determining which models or demonstration projects to 
     expand under the preceding sentence, the Secretary shall 
     focus on models and demonstration projects that improve the 
     quality of patient care and reduce spending.''.

     SEC. 3611. IMPROVEMENTS TO THE PHYSICIAN QUALITY REPORTING 
                   SYSTEM.

       (a) In General.--Section 1848(m) of the Social Security Act 
     (42 U.S.C. 1395w-4(m)) is amended by adding at the end the 
     following new paragraph:
       ``(7) Additional incentive payment.--
       ``(A) In general.--For 2011 through 2014, if an eligible 
     professional meets the requirements described in subparagraph 
     (B), the applicable quality percent for such year, as 
     described in clauses (iii) and (iv) of paragraph (1)(B), 
     shall be increased by 0.5 percentage points.
       ``(B) Requirements described.--In order to qualify for the 
     additional incentive payment described in subparagraph (A), 
     an eligible professional shall meet the following 
     requirements:
       ``(i) The eligible professional shall--

       ``(I) satisfactorily submit data on quality measures for 
     purposes of paragraph (1) for a year; and
       ``(II) have such data submitted on their behalf through a 
     Maintenance of Certification Program (as defined in 
     subparagraph (C)(i)) that meets--

       ``(aa) the criteria for a registry (as described in 
     subsection (k)(4)); or
       ``(bb) an alternative form and manner determined 
     appropriate by the Secretary.
       ``(ii) The eligible professional, more frequently than is 
     required to qualify for or maintain board certification 
     status--

       ``(I) participates in such a Maintenance of Certification 
     program for a year; and
       ``(II) successfully completes a qualified Maintenance of 
     Certification Program practice assessment (as defined in 
     subparagraph (C)(ii)) for such year.

       ``(iii) A Maintenance of Certification program submits to 
     the Secretary, on behalf of the eligible professional, 
     information--

       ``(I) in a form and manner specified by the Secretary, that 
     the eligible professional has successfully met the 
     requirements of clause (ii) (which may be in the form of a 
     structural measure);
       ``(II) if requested by the Secretary, on the survey of 
     patient experience with care (as described in subparagraph 
     (C)(ii)(II)); and
       ``(III) as the Secretary may require, on the methods, 
     measures, and data used under the Maintenance of 
     Certification Program and the qualified Maintenance of 
     Certification Program practice assessment.

       ``(C) Definitions.--For purposes of this paragraph:
       ``(i) The term `Maintenance of Certification Program' means 
     a continuous assessment program, such as qualified American 
     Board of Medical Specialties Maintenance of Certification 
     program or an equivalent program (as determined by the 
     Secretary), that advances quality and the lifelong learning 
     and self-assessment of board certified specialty physicians 
     by focusing on the competencies of patient care, medical 
     knowledge, practice-based learning, interpersonal and 
     communication skills and professionalism. Such a program 
     shall include the following:

       ``(I) The program requires the physician to maintain a 
     valid, unrestricted medical license in the United States.
       ``(II) The program requires a physician to participate in 
     educational and self-assessment programs that require an 
     assessment of what was learned.
       ``(III) The program requires a physician to demonstrate, 
     through a formalized, secure examination, that the physician 
     has the fundamental diagnostic skills, medical knowledge, and 
     clinical judgment to provide quality care in their respective 
     specialty.
       ``(IV) The program requires successful completion of a 
     qualified Maintenance of Certification Program practice 
     assessment as described in clause (ii).

       ``(ii) The term `qualified Maintenance of Certification 
     Program practice assessment' means an assessment of a 
     physician's practice that--

       ``(I) includes an initial assessment of an eligible 
     professional's practice that is designed to demonstrate the 
     physician's use of evidence-based medicine;
       ``(II) includes a survey of patient experience with care; 
     and
       ``(III) requires a physician to implement a quality 
     improvement intervention to address a practice weakness 
     identified in the initial assessment under subclause (I) and 
     then to remeasure to assess performance improvement after 
     such intervention.''.

       (b) Authority.--Section 3002(c) of this Act is amended by 
     adding at the end the following new paragraph:
       ``(3) Authority.--For years after 2014, if the Secretary of 
     Health and Human Services determines it to be appropriate, 
     the Secretary may incorporate participation in a Maintenance 
     of Certification Program and successful completion of a 
     qualified Maintenance of Certification Program practice 
     assessment into the composite of measures of quality of care 
     furnished pursuant to the physician fee schedule payment 
     modifier, as described in section 1848(p)(2) of the Social 
     Security Act (42 U.S.C. 1395w-4(p)(2)).''.
       (c) Elimination of MA Regional Plan Stabilization Fund.--
       (1) In general.--Section 1858 of the Social Security Act 
     (42 U.S.C. 1395w-27a) is amended by striking subsection (e).
       (2) Transition.--Any amount contained in the MA Regional 
     Plan Stabilization Fund as of the date of the enactment of 
     this Act shall be transferred to the Federal Supplementary 
     Medical Insurance Trust Fund.

     SEC. 3612. IMPROVEMENT IN PART D MEDICATION THERAPY 
                   MANAGEMENT (MTM) PROGRAMS.

       (a) In General.--Section 1860D-4(c)(2) of the Social 
     Security Act (42 U.S.C. 1395w-104(c)(2)) is amended--
       (1) by redesignating subparagraphs (C), (D), and (E) as 
     subparagraphs (E), (F), and (G), respectively; and
       (2) by inserting after subparagraph (B) the following new 
     subparagraphs:
       ``(C) Required interventions.--For plan years beginning on 
     or after the date that is 2 years after the date of the 
     enactment of the Patient Protection and Affordable Care Act, 
     prescription drug plan sponsors shall offer medication 
     therapy management services to targeted beneficiaries 
     described in subparagraph (A)(ii) that include, at a minimum, 
     the following to increase adherence to prescription 
     medications or other goals deemed necessary by the Secretary:
       ``(i) An annual comprehensive medication review furnished 
     person-to-person or using telehealth technologies (as defined 
     by the Secretary) by a licensed pharmacist or other qualified 
     provider. The comprehensive medication review--

       ``(I) shall include a review of the individual's 
     medications and may result in the creation of a recommended 
     medication action plan or other actions in consultation with 
     the individual and with input from the prescriber to the 
     extent necessary and practicable; and
       ``(II) shall include providing the individual with a 
     written or printed summary of the results of the review.

     The Secretary, in consultation with relevant stakeholders, 
     shall develop a standardized format for the action plan under 
     subclause (I) and the summary under subclause (II).
       ``(ii) Follow-up interventions as warranted based on the 
     findings of the annual medication review or the targeted 
     medication enrollment and which may be provided person-to-
     person or using telehealth technologies (as defined by the 
     Secretary).
       ``(D) Assessment.--The prescription drug plan sponsor shall 
     have in place a process to assess, at least on a quarterly 
     basis, the medication use of individuals who are at risk but 
     not enrolled in the medication therapy management program, 
     including individuals who have experienced a transition in 
     care, if the prescription drug plan sponsor has access to 
     that information.
       ``(E) Automatic enrollment with ability to opt-out.--The 
     prescription drug plan sponsor shall have in place a process 
     to--
       ``(i) subject to clause (ii), automatically enroll targeted 
     beneficiaries described in subparagraph (A)(ii), including 
     beneficiaries identified under subparagraph (D), in the 
     medication therapy management program required under this 
     subsection; and
       ``(ii) permit such beneficiaries to opt-out of enrollment 
     in such program.''.
       (b) Rule of Construction.--Nothing in this section shall 
     limit the authority of the Secretary of Health and Human 
     Services to modify or broaden requirements for a medication 
     therapy management program under part D of title XVIII of the 
     Social Security Act or to study new models for medication 
     therapy management through the Center for Medicare and 
     Medicaid Innovation under section 1115A of such Act, as added 
     by section 3021.

     SEC. 3613. EVALUATION OF TELEHEALTH UNDER THE CENTER FOR 
                   MEDICARE AND MEDICAID INNOVATION.

       Section 1115A(b)(2)(B) of the Social Security Act, as added 
     by section 3021, is amended by adding at the end the 
     following new clause:
       ``(xix) Utilizing, in particular in entities located in 
     medically underserved areas and facilities of the Indian 
     Health Service (whether operated by such Service or by an 
     Indian tribe or tribal organization (as those terms are 
     defined in section 4 of the Indian Health Care Improvement 
     Act)), telehealth services--

       ``(I) in treating behavioral health issues (such as post-
     traumatic stress disorder) and stroke; and
       ``(II) to improve the capacity of non-medical providers and 
     non-specialized medical providers to provide health services 
     for patients with chronic complex conditions.''.

[[Page S12920]]

     SEC. 3614. REVISIONS TO THE EXTENSION FOR THE RURAL COMMUNITY 
                   HOSPITAL DEMONSTRATION PROGRAM.

       (a) In General.--Subsection (g) of section 410A of the 
     Medicare Prescription Drug, Improvement, and Modernization 
     Act of 2003 (Public Law 108-173; 117 Stat. 2272), as added by 
     section 3123(a) of this Act, is amended to read as follows:
       ``(g) Five-Year Extension of Demonstration Program.--
       ``(1) In general.--Subject to the succeeding provisions of 
     this subsection, the Secretary shall conduct the 
     demonstration program under this section for an additional 5-
     year period (in this section referred to as the `5-year 
     extension period') that begins on the date immediately 
     following the last day of the initial 5-year period under 
     subsection (a)(5).
       ``(2) Expansion of demonstration states.--Notwithstanding 
     subsection (a)(2), during the 5-year extension period, the 
     Secretary shall expand the number of States with low 
     population densities determined by the Secretary under such 
     subsection to 20. In determining which States to include in 
     such expansion, the Secretary shall use the same criteria and 
     data that the Secretary used to determine the States under 
     such subsection for purposes of the initial 5-year period.
       ``(3) Increase in maximum number of hospitals participating 
     in the demonstration program.--Notwithstanding subsection 
     (a)(4), during the 5-year extension period, not more than 30 
     rural community hospitals may participate in the 
     demonstration program under this section.
       ``(4) Hospitals in demonstration program on date of 
     enactment.--In the case of a rural community hospital that is 
     participating in the demonstration program under this section 
     as of the last day of the initial 5-year period, the 
     Secretary--
       ``(A) shall provide for the continued participation of such 
     rural community hospital in the demonstration program during 
     the 5-year extension period unless the rural community 
     hospital makes an election, in such form and manner as the 
     Secretary may specify, to discontinue such participation; and
       ``(B) in calculating the amount of payment under subsection 
     (b) to the rural community hospital for covered inpatient 
     hospital services furnished by the hospital during such 5-
     year extension period, shall substitute, under paragraph 
     (1)(A) of such subsection--
       ``(i) the reasonable costs of providing such services for 
     discharges occurring in the first cost reporting period 
     beginning on or after the first day of the 5-year extension 
     period, for
       ``(ii) the reasonable costs of providing such services for 
     discharges occurring in the first cost reporting period 
     beginning on or after the implementation of the demonstration 
     program.''.
       (b) Conforming Amendments.--Subsection (a)(5) of section 
     410A of the Medicare Prescription Drug, Improvement, and 
     Modernization Act of 2003 (Public Law 108-173; 117 Stat. 
     2272), as amended by section 3123(b) of this Act, is amended 
     by striking ``1-year extension'' and inserting ``5-year 
     extension''.

            PART II--PROMOTING TRANSPARENCY AND COMPETITION

     SEC. 3621. DEVELOPING METHODOLOGY TO ASSESS HEALTH PLAN 
                   VALUE.

       (a) Development.--The Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary''), 
     in consultation with relevant stakeholders including health 
     insurance issuers, health care consumers, employers, health 
     care providers, and other entities determined appropriate by 
     the Secretary, shall develop a methodology to measure health 
     plan value. Such methodology shall take into consideration, 
     where applicable--
       (1) the overall cost to enrollees under the plan;
       (2) the quality of the care provided for under the plan;
       (3) the efficiency of the plan in providing care;
       (4) the relative risk of the plan's enrollees as compared 
     to other plans;
       (5) the actuarial value or other comparative measure of the 
     benefits covered under the plan; and
       (6) other factors determined relevant by the Secretary.
       (b) Report.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary shall submit to Congress 
     a report concerning the methodology developed under 
     subsection (a).

     SEC. 3622. DATA COLLECTION; PUBLIC REPORTING.

       Section 399II(a) of the Public Health Service Act, as added 
     by section 3015, is amended to read as follows:
       ``(a) In General.--
       ``(1) Establishment of strategic framework.--The Secretary 
     shall establish and implement an overall strategic framework 
     to carry out the public reporting of performance information, 
     as described in section 399JJ. Such strategic framework may 
     include methods and related timelines for implementing 
     nationally consistent data collection, data aggregation, and 
     analysis methods.
       ``(2) Collection and aggregation of data.--The Secretary 
     shall collect and aggregate consistent data on quality and 
     resource use measures from information systems used to 
     support health care delivery, and may award grants or 
     contracts for this purpose. The Secretary shall align such 
     collection and aggregation efforts with the requirements and 
     assistance regarding the expansion of health information 
     technology systems, the interoperability of such technology 
     systems, and related standards that are in effect on the date 
     of enactment of the Patient Protection and Affordable Care 
     Act.
       ``(3) Scope.--The Secretary shall ensure that the data 
     collection, data aggregation, and analysis systems described 
     in paragraph (1) involve an increasingly broad range of 
     patient populations, providers, and geographic areas over 
     time.''.

     SEC. 3623. MODERNIZING COMPUTER AND DATA SYSTEMS OF THE 
                   CENTERS FOR MEDICARE & MEDICAID SERVICES TO 
                   SUPPORT IMPROVEMENTS IN CARE DELIVERY.

       (a) In General.--The Secretary of Health and Human Services 
     (in this section referred to as the ``Secretary'') shall 
     develop a plan (and detailed budget for the resources needed 
     to implement such plan) to modernize the computer and data 
     systems of the Centers for Medicare & Medicaid Services (in 
     this section referred to as ``CMS'').
       (b) Considerations.--In developing the plan, the Secretary 
     shall consider how such modernized computer system could--
       (1) in accordance with the regulations promulgated under 
     section 264(c) of the Health Insurance Portability and 
     Accountability Act of 1996, make available data in a reliable 
     and timely manner to providers of services and suppliers to 
     support their efforts to better manage and coordinate care 
     furnished to beneficiaries of CMS programs; and
       (2) support consistent evaluations of payment and delivery 
     system reforms under CMS programs.
       (c) Posting of Plan.--By not later than 9 months after the 
     date of the enactment of this Act, the Secretary shall post 
     on the website of the Centers for Medicare & Medicaid 
     Services the plan described in subsection (a).

     SEC. 3624. EXPANSION OF THE SCOPE OF THE INDEPENDENT MEDICARE 
                   ADVISORY BOARD.

       (a) Annual Public Report.--
       (1) Report.--Section 1899A of the Social Security Act, as 
     added by section 3403, is amended by adding at the end the 
     following new subsection:
       ``(n) Annual Public Report.--
       ``(1) In general.--Not later than July 1, 2014, and 
     annually thereafter, the Board shall produce a public report 
     containing standardized information on system-wide health 
     care costs, patient access to care, utilization, and quality-
     of-care that allows for comparison by region, types of 
     services, types of providers, and both private payers and the 
     program under this title.
       ``(2) Requirements.--Each report produced pursuant to 
     paragraph (1) shall include information with respect to the 
     following areas:
       ``(A) The quality and costs of care for the population at 
     the most local level determined practical by the Board (with 
     quality and costs compared to national benchmarks and 
     reflecting rates of change, taking into account quality 
     measures described in section 1890(b)(7)(B)).
       ``(B) Beneficiary and consumer access to care, patient and 
     caregiver experience of care, and the cost-sharing or out-of-
     pocket burden on patients.
       ``(C) Epidemiological shifts and demographic changes.
       ``(D) The proliferation, effectiveness, and utilization of 
     health care technologies, including variation in provider 
     practice patterns and costs.
       ``(E) Any other areas that the Board determines affect 
     overall spending and quality of care in the private 
     sector.''.
       (2) Alignment with medicare proposals.--Section 
     1899A(c)(2)(B) of the Social Security Act, as added by 
     section 3403, is amended--
       (A) in clause (v), by striking ``and'' at the end;
       (B) in clause (vi), by striking the period at the end and 
     inserting ``; and''; and
       (C) by adding at the end the following new clause:
       ``(vii) take into account the data and findings contained 
     in the annual reports under subsection (n) in order to 
     develop proposals that can most effectively promote the 
     delivery of efficient, high quality care to Medicare 
     beneficiaries.''.
       (b) Advisory Recommendations for Non-Federal Health Care 
     Programs.--Section 1899A of the Social Security Act, as added 
     by section 3403 and as amended by subsection (a)(1), is 
     amended by adding at the end the following new subsection:
       ``(o) Advisory Recommendations for Non-Federal Health Care 
     Programs.--
       ``(1) In general.--Not later than January 15, 2015, and at 
     least once every two years thereafter, the Board shall submit 
     to Congress and the President recommendations to slow the 
     growth in national health expenditures (excluding 
     expenditures under this title and in other Federal health 
     care programs) while preserving or enhancing quality of care, 
     such as recommendations--
       ``(A) that the Secretary or other Federal agencies can 
     implement administratively;
       ``(B) that may require legislation to be enacted by 
     Congress in order to be implemented;
       ``(C) that may require legislation to be enacted by State 
     or local governments in order to be implemented;
       ``(D) that private sector entities can voluntarily 
     implement; and
       ``(E) with respect to other areas determined appropriate by 
     the Board.

[[Page S12921]]

       ``(2) Coordination.--In making recommendations under 
     paragraph (1), the Board shall coordinate such 
     recommendations with recommendations contained in proposals 
     and advisory reports produced by the Board under subsection 
     (c).
       ``(3) Available to public.--The Board shall make 
     recommendations submitted to Congress and the President under 
     this subsection available to the public.''.
       (c) Rule of Construction.--Nothing in the amendments made 
     by this section shall preclude the Independent Medicare 
     Advisory Board, as established under section 1899A of the 
     Social Security Act (as added by section 3403), from solely 
     using data from public or private sources to carry out the 
     amendments made by subsections (a)(1) and (b).

     SEC. 3625. ADDITIONAL PRIORITY FOR THE NATIONAL HEALTH CARE 
                   WORKFORCE COMMISSION.

       Section 5101(d)(4)(A) of this Act is amended by adding at 
     the end the following new clause:
       ``(v) An analysis of, and recommendations for, eliminating 
     the barriers to entering and staying in primary care, 
     including provider compensation.''.

         PART III--PROMOTING ACCOUNTABILITY AND RESPONSIBILITY

     SEC. 3631. HEALTH CARE FRAUD ENFORCEMENT.

       (a) Fraud Sentencing Guidelines.--
       (1) Definition.--In this subsection, the term ``Federal 
     health care offense'' has the meaning given that term in 
     section 24 of title 18, United States Code, as amended by 
     this Act.
       (2) Review and amendments.--Pursuant to the authority under 
     section 994 of title 28, United States Code, and in 
     accordance with this subsection, the United States Sentencing 
     Commission shall--
       (A) review the Federal Sentencing Guidelines and policy 
     statements applicable to persons convicted of Federal health 
     care offenses;
       (B) amend the Federal Sentencing Guidelines and policy 
     statements applicable to persons convicted of Federal health 
     care offenses involving Government health care programs to 
     provide that the aggregate dollar amount of fraudulent bills 
     submitted to the Government health care program shall 
     constitute prima facie evidence of the amount of the intended 
     loss by the defendant; and
       (C) amend the Federal Sentencing Guidelines to provide--
       (i) a 2-level increase in the offense level for any 
     defendant convicted of a Federal health care offense relating 
     to a Government health care program which involves a loss of 
     not less than $1,000,000 and less than $7,000,000;
       (ii) a 3-level increase in the offense level for any 
     defendant convicted of a Federal health care offense relating 
     to a Government health care program which involves a loss of 
     not less than $7,000,000 and less than $20,000,000;
       (iii) a 4-level increase in the offense level for any 
     defendant convicted of a Federal health care offense relating 
     to a Government health care program which involves a loss of 
     not less than $20,000,000; and
       (iv) if appropriate, otherwise amend the Federal Sentencing 
     Guidelines and policy statements applicable to persons 
     convicted of Federal health care offenses involving 
     Government health care programs.
       (3) Requirements.--In carrying this subsection, the United 
     States Sentencing Commission shall--
       (A) ensure that the Federal Sentencing Guidelines and 
     policy statements--
       (i) reflect the serious harms associated with health care 
     fraud and the need for aggressive and appropriate law 
     enforcement action to prevent such fraud; and
       (ii) provide increased penalties for persons convicted of 
     health care fraud offenses in appropriate circumstances;
       (B) consult with individuals or groups representing health 
     care fraud victims, law enforcement officials, the health 
     care industry, and the Federal judiciary as part of the 
     review described in paragraph (2);
       (C) ensure reasonable consistency with other relevant 
     directives and with other guidelines under the Federal 
     Sentencing Guidelines;
       (D) account for any aggravating or mitigating circumstances 
     that might justify exceptions, including circumstances for 
     which the Federal Sentencing Guidelines, as in effect on the 
     date of enactment of this Act, provide sentencing 
     enhancements;
       (E) make any necessary conforming changes to the Federal 
     Sentencing Guidelines; and
       (F) ensure that the Federal Sentencing Guidelines 
     adequately meet the purposes of sentencing.
       (b) Intent Requirement for Health Care Fraud.--Section 1347 
     of title 18, United States Code, is amended--
       (1) by inserting ``(a)'' before ``Whoever knowingly''; and
       (2) by adding at the end the following:
       ``(b) With respect to violations of this section, a person 
     need not have actual knowledge of this section or specific 
     intent to commit a violation of this section.''.
       (c) Health Care Fraud Offense.--Section 24(a) of title 18, 
     United States Code, is amended--
       (1) in paragraph (1), by striking the semicolon and 
     inserting ``or section 1128B of the Social Security Act (42 
     U.S.C. 1320a-7b); or''; and
       (2) in paragraph (2)--
       (A) by inserting ``1349,'' after ``1343,''; and
       (B) by inserting ``section 301 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 331), or section 501 of the 
     Employee Retirement Income Security Act of 1974 (29 U.S.C. 
     1131),'' after ``title,''.
       (d) Subpoena Authority Relating to Health Care.--
       (1) Subpoenas under the health insurance portability and 
     accountability act of 1996.--Section 1510(b) of title 18, 
     United States Code, is amended--
       (A) in paragraph (1), by striking ``to the grand jury''; 
     and
       (B) in paragraph (2)--
       (i) in subparagraph (A), by striking ``grand jury 
     subpoena'' and inserting ``subpoena for records''; and
       (ii) in the matter following subparagraph (B), by striking 
     ``to the grand jury''.
       (2) Subpoenas under the civil rights of institutionalized 
     persons act.--The Civil Rights of Institutionalized Persons 
     Act (42 U.S.C. 1997 et seq.) is amended by inserting after 
     section 3 the following:

     ``SEC. 3A. SUBPOENA AUTHORITY.

       ``(a) Authority.--The Attorney General, or at the direction 
     of the Attorney General, any officer or employee of the 
     Department of Justice may require by subpoena access to any 
     institution that is the subject of an investigation under 
     this Act and to any document, record, material, file, report, 
     memorandum, policy, procedure, investigation, video or audio 
     recording, or quality assurance report relating to any 
     institution that is the subject of an investigation under 
     this Act to determine whether there are conditions which 
     deprive persons residing in or confined to the institution of 
     any rights, privileges, or immunities secured or protected by 
     the Constitution or laws of the United States.
       ``(b) Issuance and Enforcement of Subpoenas.--
       ``(1) Issuance.--Subpoenas issued under this section--
       ``(A) shall bear the signature of the Attorney General or 
     any officer or employee of the Department of Justice as 
     designated by the Attorney General; and
       ``(B) shall be served by any person or class of persons 
     designated by the Attorney General or a designated officer or 
     employee for that purpose.
       ``(2) Enforcement.--In the case of contumacy or failure to 
     obey a subpoena issued under this section, the United States 
     district court for the judicial district in which the 
     institution is located may issue an order requiring 
     compliance. Any failure to obey the order of the court may be 
     punished by the court as a contempt that court.
       ``(c) Protection of Subpoenaed Records and Information.--
     Any document, record, material, file, report, memorandum, 
     policy, procedure, investigation, video or audio recording, 
     or quality assurance report or other information obtained 
     under a subpoena issued under this section--
       ``(1) may not be used for any purpose other than to protect 
     the rights, privileges, or immunities secured or protected by 
     the Constitution or laws of the United States of persons who 
     reside, have resided, or will reside in an institution;
       ``(2) may not be transmitted by or within the Department of 
     Justice for any purpose other than to protect the rights, 
     privileges, or immunities secured or protected by the 
     Constitution or laws of the United States of persons who 
     reside, have resided, or will reside in an institution; and
       ``(3) shall be redacted, obscured, or otherwise altered if 
     used in any publicly available manner so as to prevent the 
     disclosure of any personally identifiable information.''.

     SEC. 3632. DEVELOPMENT OF STANDARDS FOR FINANCIAL AND 
                   ADMINISTRATIVE TRANSACTIONS.

       (a) Additional Transaction Standards and Operating Rules.--
       (1) Development of additional transaction standards and 
     operating rules.--Section 1173(a) of the Social Security Act 
     (42 U.S.C. 1320d-2(a)), as amended by section 1104(b)(2), is 
     amended--
       (A) in paragraph (1)(B), by inserting before the period the 
     following: ``, and subject to the requirements under 
     paragraph (5)''; and
       (B) by adding at the end the following new paragraph:
       ``(5) Consideration of standardization of activities and 
     items.--
       ``(A) In general.--For purposes of carrying out paragraph 
     (1)(B), the Secretary shall solicit, not later than January 
     1, 2012, and not less than every 3 years thereafter, input 
     from entities described in subparagraph (B) on--
       ``(i) whether there could be greater uniformity in 
     financial and administrative activities and items, as 
     determined appropriate by the Secretary; and
       ``(ii) whether such activities should be considered 
     financial and administrative transactions (as described in 
     paragraph (1)(B)) for which the adoption of standards and 
     operating rules would improve the operation of the health 
     care system and reduce administrative costs.
       ``(B) Solicitation of input.--For purposes of subparagraph 
     (A), the Secretary shall seek input from--
       ``(i) the National Committee on Vital and Health 
     Statistics, the Health Information Technology Policy 
     Committee, and the Health Information Technology Standards 
     Committee; and
       ``(ii) standard setting organizations and stakeholders, as 
     determined appropriate by the Secretary.''.

[[Page S12922]]

       (b) Activities and Items for Initial Consideration.--For 
     purposes of section 1173(a)(5) of the Social Security Act, as 
     added by subsection (a), the Secretary of Health and Human 
     Services (in this section referred to as the ``Secretary'') 
     shall, not later than January 1, 2012, seek input on 
     activities and items relating to the following areas:
       (1) Whether the application process, including the use of a 
     uniform application form, for enrollment of health care 
     providers by health plans could be made electronic and 
     standardized.
       (2) Whether standards and operating rules described in 
     section 1173 of the Social Security Act should apply to the 
     health care transactions of automobile insurance, worker's 
     compensation, and other programs or persons not described in 
     section 1172(a) of such Act (42 U.S.C. 1320d-1(a)).
       (3) Whether standardized forms could apply to financial 
     audits required by health plans, Federal and State agencies 
     (including State auditors, the Office of the Inspector 
     General of the Department of Health and Human Services, and 
     the Centers for Medicare & Medicaid Services), and other 
     relevant entities as determined appropriate by the Secretary.
       (4) Whether there could be greater transparency and 
     consistency of methodologies and processes used to establish 
     claim edits used by health plans (as described in section 
     1171(5) of the Social Security Act (42 U.S.C. 1320d(5))).
       (5) Whether health plans should be required to publish 
     their timeliness of payment rules.
       (c) ICD Coding Crosswalks.--
       (1) ICD-9 to icd-10 crosswalk.--The Secretary shall task 
     the ICD-9-CM Coordination and Maintenance Committee to 
     convene a meeting, not later than January 1, 2011, to receive 
     input from appropriate stakeholders (including health plans, 
     health care providers, and clinicians) regarding the 
     crosswalk between the Ninth and Tenth Revisions of the 
     International Classification of Diseases (ICD-9 and ICD-10, 
     respectively) that is posted on the website of the Centers 
     for Medicare & Medicaid Services, and make recommendations 
     about appropriate revisions to such crosswalk.
       (2) Revision of crosswalk.--For purposes of the crosswalk 
     described in paragraph (1), the Secretary shall make 
     appropriate revisions and post any such revised crosswalk on 
     the website of the Centers for Medicare & Medicaid Services.
       (3) Use of revised crosswalk.--For purposes of paragraph 
     (2), any revised crosswalk shall be treated as a code set for 
     which a standard has been adopted by the Secretary for 
     purposes of section 1173(c)(1)(B) of the Social Security Act 
     (42 U.S.C. 1320d-2(c)(1)(B)).
       (4) Subsequent crosswalks.--For subsequent revisions of the 
     International Classification of Diseases that are adopted by 
     the Secretary as a standard code set under section 1173(c) of 
     the Social Security Act (42 U.S.C. 1320d-2(c)), the Secretary 
     shall, after consultation with the appropriate stakeholders, 
     post on the website of the Centers for Medicare & Medicaid 
     Services a crosswalk between the previous and subsequent 
     version of the International Classification of Diseases not 
     later than the date of implementation of such subsequent 
     revision.
                                 ______
                                 
  SA 3120. Mr. CRAPO submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       Beginning on page 1997, strike line 1 and all that follows 
     through page 1998, line 12.
                                 ______
                                 
  SA 3121. Mr. CRAPO submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       Beginning on page 2045, strike line 1 and all that follows 
     through page 2046, line 24.
                                 ______
                                 
  SA 3122. Mr. CRAPO submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 1998, strike lines 13 through 24.
                                 ______
                                 
  SA 3123. Mr. CRAPO submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       Beginning on page 2034, strike line 16 and all that follows 
     through page 2035, line 15.
                                 ______
                                 
  SA 3124. Mr. CRAPO submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       Beginning on page 2040, strike line 18 and all that follows 
     through page 2044, line 7.
                                 ______
                                 
  SA 3125. Mr. CRAPO submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 1999, strike lines 1 through 20.
                                 ______
                                 
  SA 3126. Mr. CRAPO submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 2074, after line 25, insert the following:

     SEC. 9024. EXEMPTION FROM TAXES, FEES, AND PENALTIES.

       (a) In General.--No tax, fee, or penalty imposed by this 
     Act shall apply to any taxpayer for any taxable year if, as 
     determined by the Secretary of the Treasury, such tax, fee, 
     or penalty would increase the rate of tax imposed on such 
     taxpayer under any provision of the Internal Revenue Code of 
     1986 or any other applicable Federal law in effect on the day 
     before the date of the enactment of this Act, as compared to 
     the rate of tax imposed on such taxpayer under such provision 
     of law on December 31, 1999.
       (b) New Taxpayers.--In the case of a taxpayer that was not 
     in existence on December 31, 1999, or that had no Federal tax 
     liability on such date, subsection (a) shall be applied by 
     substituting ``December 31 of the first calendar year after 
     1999 in which such taxpayer had Federal tax liability greater 
     than zero'' for ``December 31, 1999''.
                                 ______
                                 
  SA 3127. Mr. MERKLEY (for himself and Mrs. Murray) submitted an 
amendment intended to be proposed to amendment SA 2786 proposed by Mr. 
Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the bill 
H.R. 3590, to amend the Internal Revenue Code of 1986 to modify the 
first-time homebuyers credit in the case of members of the Armed Forces 
and certain other Federal employees, and for other purposes; which was 
ordered to lie on the table; as follows:

       On page 1382, between lines 10 and 11, insert the 
     following:
       (c) Advanced Technology Education Program for Nursing.--
     Title VIII of the Public Health Service Act is amended by 
     inserting after section 831A (42 U.S.C. 296b), as added by 
     subsection (b), the following:

     ``SEC. 831B. ADVANCED TECHNOLOGY EDUCATION PROGRAM FOR 
                   NURSING.

       ``(a) In General.--The Secretary, acting through the 
     Administrator of the Health Resources and Services 
     Administration, shall establish a grant program to assist 
     consortia in advancing nursing education and the career 
     ladder.
       ``(b) Program Design.--The grant program established under 
     subsection (a) shall--
       ``(1) be designed to strengthen and expand the nursing 
     career ladder, particularly with regard to innovative 
     programs that encourage registered nurses to pursue advanced 
     degrees in nursing, with an emphasis on integrating 
     innovative technology into nursing education programs; and
       ``(2) place emphasis on the needs of nontraditional 
     students and underserved groups.
       ``(c) Applications.--An application for a grant under 
     subsection (a) shall be submitted--
       ``(1) by a two-year educational institution on behalf of 
     the consortia seeking the grant; and
       ``(2) at such time, in such manner, and containing such 
     information as the Secretary may require.
       ``(d) Advanced Technology Education Projects in Nursing.--
     Funds made available

[[Page S12923]]

     through a grant under subsection (a) shall be used to support 
     nursing education projects, to enhance nursing education 
     programs, and to assist students in transferring academic 
     credit from a two-year educational institution to an advanced 
     degree program in nursing through activities such as--
       ``(1) alignment and enhancement of curriculum to ensure 
     that academic credit earned at a two-year educational 
     institutions can be transferred to baccalaureate or graduate 
     degree programs in nursing;
       ``(2) establishment of innovative partnerships and 
     articulation agreements to facilitate the transfer by 
     students of academic credit from a two-year educational 
     institution to an advanced degree program in nursing;
       ``(3) the purchase or lease of state-of-the-art 
     technologies essential in developing innovative nursing 
     education programs and in preparing nursing students to use 
     current and future health technologies, such as simulation 
     and visualization tools and telehealth;
       ``(4) the acquisition of technical support necessary for 
     developing innovative nursing curriculum and advanced 
     technology training capabilities among nursing faculty;
       ``(5) professional development and training of nursing 
     faculty, both full- and part-time, in the nursing profession;
       ``(6) development and dissemination of exemplary curricula 
     and instructional materials in nursing;
       ``(7) development and implementation of innovative 
     workshops, mentoring activities, and professional development 
     activities for nursing students, registered nurses, and 
     nursing faculty to encourage education advancement and 
     retention in a nursing career; and
       ``(8) development and implementing internship programs for 
     nurses or nursing students to encourage mentoring.
       ``(e) Definition.--In this section--
       ``(1) the term `consortia' means a collaboration that--
       ``(A) shall include a two-year educational institution in 
     partnership with a four-year college or university; and
       ``(B) may include one or more of the following: another 
     two-year or four-year college or university, a school of 
     nursing, the private sector, a State or local government, a 
     State workforce investment board, a local workforce 
     investment board, a community-based allied health program, a 
     health professions school, a teaching hospital, a graduate 
     medical education program, an academic health center, and any 
     other appropriate public or private non-profit entity;

     in order to inform and improve nursing education programs;
       ``(2) the term `four-year educational institution' means a 
     department, division, or other administrative unit in a 
     college or university which provides primarily or exclusively 
     an accredited program in professional nursing and related 
     subjects leading to the degree of bachelor of arts, bachelor 
     of science, bachelor of nursing, or to an equivalent degree, 
     or to a graduate degree in nursing, or to an equivalent 
     degree, and including advanced training related to such 
     program of education provided by such school;
       ``(3) the term `local workforce investment board' refers to 
     a local workforce investment board established under section 
     117 of the Workforce Investment Act of 1998 (29 U.S.C. 2832);
       ``(4) the term `State workforce investment board' refers to 
     a State workforce investment board established under section 
     111 of the Workforce Investment Act of 1998 (29 U.S.C. 2821); 
     and
       ``(5) the term `two-year educational institution' means a 
     department, division, or other administrative unit in a 
     junior or community college which provides primarily or 
     exclusively a two-year accredited nursing program leading to 
     an associate degree in nursing or an equivalent degree, but 
     only if such program, or such unit or college, is accredited.
       ``(f) Funding.--There are authorized to be appropriated to 
     award grants under this section, $12,000,000 for fiscal year 
     2010 and such sums as may be necessary for each of fiscal 
     years 2011 through 2015.''.
                                 ______
                                 
  SA 3128. Mr. KOHL submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 921, between lines 20 and 21, insert the following:

     SEC. 3210. EXPANSION OF 340B PROGRAM COVERED ENTITIES AND 
                   RECEIPT BY CERTAIN PACE PROGRAMS AND SNPS OF 
                   PERCENTAGE OF SAVINGS FROM PARTICIPATION IN 
                   340B PROGRAM.

       (a) Expansion of 340B Program Covered Entities.--Section 
     340B(a)(4) of the Public Health Service Act (42 U.S.C. 
     256b(a)(4)), as amended by section 7101, is further amended 
     by adding at the end the following:
       ``(P) An entity that is--
       ``(i) a PACE program under section 1894 of the Social 
     Security Act; or
       ``(ii) a specialized MA plan for special needs individuals 
     described in section 1859(b)(6)(B)(ii) of such Act, all or 
     nearly all of whom are nursing home certifiable, that is 
     fully integrated with capitated contracts with States for 
     Medicaid benefits.''.
       (b) Receipt by Certain PACE Programs and SNPs of Percentage 
     of Savings From Participation in 340B Program.--
       (1) PACE programs.--Section 1894 of the Social Security Act 
     (42 U.S.C. 1395eee), as amended by section 3201(i), is 
     further amended--
       (A) by redesignating subsections (i) and (j) as subsections 
     (j) and (k), respectively; and
       (B) by inserting after subsection (h) the following new 
     subsection:
       ``(i) Receipt by Certain PACE Programs of Percentage of 
     Savings From Participation in 340B Program.--
       ``(1) In general.--An applicable PACE program is eligible 
     to receive from the Secretary an amount equal to 10 percent 
     of the estimated savings to the program under this title as a 
     result of participation in the program under section 340B of 
     the Public Health Service Act (as determined by the 
     Secretary).
       ``(2) Applicable pace program defined.--For purposes of 
     paragraph (1), the term `applicable PACE program' means a 
     PACE program that--
       ``(A) is participating in the program under section 340B of 
     the Public Health Service Act;
       ``(B) submits to the Secretary an application in such form 
     and manner, and containing such information, as the Secretary 
     may specify; and
       ``(C) has in effect a plan approved by the Secretary for 
     the use of any amounts received by the program or plan under 
     paragraph (1) to provide enhanced formulary coverage, 
     medication management, or disease management to enrollees.''.
       (2) SNPS.--Section 1859 of the Social Security Act (42 
     U.S.C. 1395w-28), as amended by section 3208, is further 
     amended by adding at the end the following new subsection:
       ``(h) Receipt by Certain SNPs of Percentage of Savings From 
     Participation in 340B Program.--
       ``(1) In general.--An applicable specialized MA plan for 
     specialized needs individuals is eligible to receive from the 
     Secretary an amount equal to 10 percent of the estimated 
     savings to the program under this title as a result of 
     participation in the program under section 340B of the Public 
     Health Service Act (as determined by the Secretary).
       ``(2) Applicable specialized ma plan for special needs 
     individuals defined.--For purposes of paragraph (1), the term 
     `applicable specialized MA plan for special needs 
     individuals' means a specialized MA plan for special needs 
     individuals described in subsection (b)(6)(B)(ii), all or 
     nearly all of whom are nursing home certifiable, that is 
     fully integrated with capitated contracts with States for 
     Medicaid benefits that--
       ``(A) is participating in the program under section 340B of 
     the Public Health Service Act;
       ``(B) submits to the Secretary an application in such form 
     and manner, and containing such information, as the Secretary 
     may specify; and
       ``(C) has in effect a plan approved by the Secretary for 
     the use of any amounts received by the program or plan under 
     paragraph (1) to provide enhanced formulary coverage, 
     medication management, or disease management to enrollees.''.
       (c) Development of New Program.--The Secretary of Health 
     and Human Services may develop and implement a program 
     whereby such Secretary enters into an agreement with 
     manufacturers that participate in the program under section 
     340B of the Public Health Service Act (42 U.S.C. 256b) under 
     which enrollees in PACE programs under section 1894 of the 
     Social Security Act (42 U.S.C. 1395eee) and specialized MA 
     plans for special needs individuals described in section 
     1859(b)(6)(B)(ii) of such Act (42 U.S.C. 1395w-28) may 
     receive covered drugs (as defined under such section 340B) 
     from pharmacies selected by the PACE program or specialized 
     MA plan, including local pharmacies.
                                 ______
                                 
  SA 3129. Mrs. MURRAY submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 1411, between lines 5 and 6, insert the following:

     SEC. 5316. SECONDARY SCHOOL HEALTH SCIENCES TRAINING PROGRAM.

       (a) Program Authorized.--
       (1) In general.--The Secretary is authorized to establish a 
     health sciences training program consisting of awarding 
     grants, on a competitive basis, to eligible recipients to 
     enable the eligible recipients to prepare secondary school 
     students for careers in health professions.
       (2) Consultation and collaboration.--The Secretary of 
     Education shall--
       (A) consult with the Secretary of Health and Human Services 
     and the Secretary of Labor prior to the issuance of a 
     solicitation for grant applications under this section; and

[[Page S12924]]

       (B) specifically collaborate with the Secretary of Health 
     and Human Services to coordinate the program under this 
     section with any programs administered by the Health 
     Resources and Services Administration that create a pipeline 
     of professionals for the health care workforce.
       (b) Development and Implementation of Health Sciences 
     Programs of Study.--An eligible recipient receiving a grant 
     under this section shall use grant funds--
       (1) to implement a secondary school health sciences program 
     of study that--
       (A) meets the requirements for a career and technical 
     program of study under section 122(c)(1)(A) of the Carl D. 
     Perkins Career and Technical Education Act of 2006 (20 U.S.C. 
     2342(c)(1)(A));
       (B) is aligned with--
       (i) the career and technical programs of study supported by 
     the State in which the eligible recipient is located, in 
     accordance with the State's plan under section 122(c) of such 
     Act (20 U.S.C. 2342(c)); and
       (ii) any technical standards required for State licensure 
     in a health profession; and
       (C) prepares students for--
       (i) a postsecondary certificate, credential, or accredited 
     associate's or baccalaureate degree program in the health 
     profession; or
       (ii) an accredited baccalaureate degree program in an 
     academic major related to the health profession; and
       (2) to increase the interest of secondary school students 
     in applying to, and enrolling in, programs described in 
     clause (i) or (ii) of paragraph (1)(C), including through--
       (A) work-study programs;
       (B) pre-apprenticeship programs;
       (C) programs to increase awareness of careers in health 
     professions; or
       (D) other activities to increase such interest.
       (c) Eligibility.--To be eligible for a grant under this 
     section, an eligible recipient shall--
       (1) provide assurances that activities under the grant will 
     be carried out in partnership with--
       (A) an accredited health professions school or program at 
     the postsecondary level; and
       (B) a public or private nonprofit hospital or public or 
     private nonprofit entity with a focus on health sciences or 
     health professions; and
       (2) provide an explanation of how activities under the 
     grant are consistent with the State plan and local plan being 
     implemented under sections 122 and 134, respectively, of the 
     Carl D. Perkins Career and Technical Education Act of 2006 
     (20 U.S.C. 2342, 2354), for the area to be served by the 
     grant.
       (d) Preference.--In awarding grants under this section, the 
     Secretary shall give preference to an eligible recipient that 
     has a demonstrated record of not less than one of the 
     following:
       (1) Graduating, or collaborating with an eligible recipient 
     that graduates, a high or significantly improved percentage 
     of students who have exhibited mastery in secondary school 
     State science standards.
       (2) Graduating students from disadvantaged backgrounds, 
     including racial and ethnic minorities who are 
     underrepresented in--
       (A) the programs described in clause (i) or (ii) of 
     subsection (b)(1)(C); or
       (B) the health professions.
       (e) Report.--The Secretary shall submit to Congress an 
     annual report on the program carried out under this section.
       (f) Definitions.--In this section:
       (1) Eligible recipient.--The term ``eligible recipient'' 
     means an eligible recipient described in section 3(14)(A) of 
     the Carl D. Perkins Career and Technical Education Act of 
     2006 (20 U.S.C. 2302(14)(A)).
       (2) Health care workforce.--The term ``health care 
     workforce'' has the meaning given the term in section 
     5101(i).
       (3) Health profession.--The term ``health profession'' 
     means the profession of a member of the health care 
     workforce.
       (4) Local educational agency.--The term ``local educational 
     agency'' has the meaning given the term in section 9101 of 
     the Elementary and Secondary Education Act of 1965 (20 U.S.C. 
     7801).
       (5) Secondary school.--The term ``secondary school''--
       (A) means a secondary school, as defined in section 9101 of 
     the Elementary and Secondary Education Act of 1965 (20 U.S.C. 
     7801); and
       (B) includes a middle school.
       (6) Secretary.--The term ``Secretary'' means the Secretary 
     of Education, except as otherwise specified.
       (g) Authorization of Appropriations.--There is authorized 
     to be appropriated to carry out this section such sums as may 
     be necessary for each of the fiscal years 2011 through 2015.
                                 ______
                                 
  SA 3130. Mr. JOHANNS submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 245, between lines 14 and 15, and insert the 
     following:
       (B) Special rule for low-income adults not eligible for 
     medicaid.--If a taxpayer is an individual who, but for the 
     application of section 1902(k)(2) of the Social Security Act, 
     a State would be required under subclause (VIII) of 
     subsection (a)(10)(A)(i) to provide medical assistance to 
     under the State Medicaid plan, the taxpayer shall--
       (i) 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 2.0 
     percent; and
       (ii) for purposes of reduced cost-sharing under section 
     1402 of the Patient Protection and Affordable Care Act, shall 
     be treated as having household income of more than 100 
     percent but less than 150 percent of the poverty line (as so 
     defined) applicable to a family of the size involved.
       On page 398, between lines 9 and 10, insert the following:
       (B) Special rules for states with a budget deficit or at 
     risk of having to raise taxes or being unable to deliver 
     essential state functions.--Section 1902(k) of such Act (42 
     U.S.C. 1396a(k)), as added by subparagraph (A), is amended by 
     adding at the end the following:
       ``(2) If a State submits a certification to the Secretary 
     in 2013 that in 2014, complying with the requirement under 
     subclause (VIII) of subsection (a)(10)(A)(i) to provide 
     medical assistance to individuals described in that subclause 
     would cause the State to have a budget deficit, or require 
     the State to raise taxes, or reduce or eliminate spending for 
     education, transportation, law enforcement or other essential 
     State functions, then, in the case of individuals described 
     in the subclause who have attained 19 years of age, the State 
     only shall be required to provide medical assistance under 
     that subclause to those individuals with income (as 
     determined under subsection (e)(14)) that does not exceed 75 
     percent of the poverty line (as defined in section 
     2110(c)(5)) applicable to a family of the size involved.''.
                                 ______
                                 
  SA 3131. Mr. KOHL (for himself and Mr. Durbin) submitted an amendment 
intended to be proposed to amendment SA 2786 proposed by Mr. Reid (for 
himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the bill H.R. 3590, 
to amend the Internal Revenue Code of 1986 to modify the first-time 
homebuyers credit in the case of members of the Armed Forces and 
certain other Federal employees, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

                  TITLE __--PROHIBITION ON DATA MINING

     SEC. _01. PURPOSE.

       (a) In General.--It is the purpose of this title to--
       (1) safeguard the confidentiality of prescribing 
     information;
       (2) protect the integrity of the doctor-patient 
     relationship;
       (3) maintain the integrity and public trust in the medical 
     profession;
       (4) combat vexatious and harassing sales practices;
       (5) restrain undue influence exerted by pharmaceutical 
     industry marketing representatives over prescribing 
     decisions; and
       (6) improve the quality and lower the cost of health care.
       (b) Rule of Construction.--Nothing in this title shall be 
     construed to regulate the monitoring of prescribing practices 
     for uses other than marketing (such as quality control, 
     research unrelated to marketing, or use by governments or 
     other entities not in the business of selling health care 
     products).

     SEC. _02. DEFINITIONS.

       In this title:
       (1) Bona fide clinical trial.--The term ``bona fide 
     clinical trial'' means any research project that--
       (A) prospectively assigns human subjects to intervention 
     and comparison groups to study the cause and effect 
     relationship between a medical intervention and a health 
     outcome;
       (B) has received approval from an appropriate Institutional 
     Review Board; and
       (C) has been registered at ClinicalTrials.Gov prior to 
     commencement.
       (2) Company making or selling prescribed products.--The 
     term ``company making or selling prescribed products'' means 
     a pharmacy, a pharmacy benefit manager, a pharmaceutical 
     manufacturer, pharmaceutical wholesaler, or any other entity 
     whose primary purpose is the marketing of pharmaceutical 
     product for financial gain. Such term does not include health 
     plans, health care providers, or State or Federal public 
     health programs and research organizations.
       (3) Individual identifying information.--The term 
     ``individual identifying information'' means information that 
     directly or indirectly identifies a prescriber or a patient, 
     where the information is derived from or relates to a 
     prescription for any prescribed product.
       (4) Health care provider.--The term ``health care 
     provider'' means a provider of services (as defined in 
     section 1861(u) of the Act, 42 U.S.C. 1395x(u)), a provider 
     of medical or health services (as defined in section 1861(s) 
     of the Act, 42 U.S.C. 1395x(s)), and any other person or 
     organization who furnishes, bills, or is paid for health care 
     in the normal course of business.
       (5) Health plan.--

[[Page S12925]]

       (A) In general.--The term ``health plan'' means an 
     individual or group plan that provides, or pays the cost of, 
     medical care (as defined in section 2791(a)(2) of the Public 
     Health Service Act (42 U.S.C. 300gg-91(a)(2))). Such term 
     includes the following (singly or in combination):
       (i) A group health plan, as defined in section 2791 of the 
     Public Health Service Act (42 U.S.C. 300gg-91).
       (ii) A health insurance issuer, as defined in section 2791 
     of the Public Health Service Act (42 U.S.C. 300gg-91).
       (iii) A health maintenance organization, as defined in 
     section 2791 of the Public Health Service Act (42 U.S.C. 
     300gg-91).
       (iv) Part A or part B of the Medicare program under title 
     XVIII of the Social Security Act (42 U.S.C. 1395 et seq.).
       (v) The Medicaid program under title XIX of the Act, 42 
     U.S.C. 1396, et seq.
       (vi) An issuer of a Medicare supplemental policy (as 
     defined in section 1882(g)(1) of the Act, 42 U.S.C. 
     1395ss(g)(1))).
       (vii) An issuer of a long-term care policy, excluding a 
     nursing home fixed-indemnity policy.
       (viii) An employee welfare benefit plan or any other 
     arrangement that is established or maintained for the purpose 
     of offering or providing health benefits to the employees of 
     two or more employers.
       (ix) The health care program for active military personnel 
     under title 10, United States Code.
       (x) The veterans health care program under chapter 17 of 
     title 38, United States Code.
       (xi) The Civilian Health and Medical Program of the 
     Uniformed Services (CHAMPUS) (as defined in section 1072(4) 
     of title 10, United States Code).
       (xii) The Indian Health Service program under the Indian 
     Health Care Improvement Act (25 U.S.C. 1601, et seq).
       (xiii) The Federal Employees Health Benefits Program under 
     chapter 89 of title 5, United States Code.
       (xiv) An approved State child health plan under title XXI 
     of the Social Security Act, providing benefits for child 
     health assistance that meet the requirements of section 2103 
     of such Act (42 U.S.C. 1397, et seq).
       (xv) The Medicare+Choice program under Part C of title 
     XVIII of the Social Security Act (42 U.S.C. 1395w-21 et 
     seq.).
       (xvi) A high risk pool that is a mechanism established 
     under State law to provide health insurance coverage or 
     comparable coverage to eligible individuals.
       (xvii) Any other individual or group plan, or combination 
     of individual or group plans, that provides or pays for the 
     cost of medical care (as defined in section 2791(a)(2) of the 
     Public Health Service Act (42 U.S.C. 300gg-91(a)(2))).
       (B) Limitation.--Such terms shall not include the 
     following:
       (i) Any policy, plan, or program to the extent that it 
     provides, or pays for the cost of, excepted benefits that are 
     listed in section 2791(c)(1) of the Public Health Service Act 
     (42 U.S.C. 300gg-91(c)(1)).
       (ii) A government-funded program (other than a program 
     listed in clauses (i) through (xvi) of subparagraph (A)--

       (I) whose principal purpose is other than providing, or 
     paying the cost of, health care; or
       (II) whose principal activity is--

       (aa) the direct provision of health care to persons; or
       (bb) the making of grants to fund the direct provision of 
     health care to persons.
       (6) Marketing.--The term ``marketing'' means any activity 
     advertising, promoting, or selling a prescribed product for 
     commercial gain, including--
       (A) identifying individuals to receive a message promoting 
     use of a particular product;
       (B) identifying individuals to receive any form of gift, 
     product sample, consultancy, or any other item, service, 
     compensation or employment of value;
       (C) planning the substance of a sales representative visit 
     or communication or the substance of an advertisement or 
     other promotional message or document; or
       (D) evaluating or compensating sales representatives.
       (7) Person.--The term ``person'' means a natural person, 
     trust or estate, partnership, corporation, professional 
     association or corporation, or other entity, public or 
     private.
       (8) Pharmacy.--The term ``pharmacy'' means any person 
     licensed under State or Federal law to dispense prescribed 
     products.
       (9) Prescribed product.--The term ``prescribed product'' 
     includes a biological product as defined in section 351 of 
     the Public Health Service Act (42 U.S.C. 262) and a device or 
     a drug as defined in section 201 of the Federal Food, Drug 
     and Cosmetic Act (21 U.S.C. 321).
       (10) Regulated record.--The term ``regulated record'' means 
     information or documentation from a prescription.

     SEC. _03. PRIVACY PROTECTIONS.

       (a) Prohibition.--No company or person in possession of 
     regulated records, or their agents, or those acting on their 
     behalf shall knowingly disclose, sell, or use regulated 
     records containing individual identifying information for 
     marketing a prescribed product.
       (b) Permitted Transfers.--A regulated record containing 
     individual identifying information may be transferred to 
     another entity, including to another branch or subsidiary of 
     the same entity, only if the transfer provides satisfactory 
     assurance that the recipient will safeguard the records from 
     being disclosed or used for a marketing purpose prohibited 
     under this section.
       (c) Permitted Uses.--
       (1) In general.--Regulated records containing individual 
     identifying information may be disclosed, sold, transferred, 
     exchanged, or used for any purpose other than marketing a 
     prescribed product, including--
       (A) to fill a valid prescription, including communication 
     by a pharmacist about patient safety or generic substitution, 
     or in response to patient or physician questions about a 
     medication, as well as any transfer necessary for billing or 
     pharmacy reimbursement;
       (B) to conduct of a bona fide clinical trial;
       (C) to disseminate safety warnings, labeling changes, risk 
     evaluation and mitigation strategies (REMS) compliance 
     communications, or to facilitate adverse event reporting, or 
     to otherwise implement a REMS;
       (D) for the purposes of academic detailing or public health 
     communications;
       (E) for the administration of a patient's health insurance 
     or benefits plan, including determining compliance with the 
     terms of coverage or medical necessity; or
       (F) to comply with existing State or Federal law.
       (2) Rules of construction.--This section shall not be 
     construed to--
       (A) prohibit any communication between a health care 
     provider and patients under his or her care, or any 
     communication between health care providers for the purpose 
     of patient care;
       (B) prohibit the use of data by a health plan or a pharmacy 
     benefit manager where such plan or manager is acting in the 
     fiduciary interest of such organizations, for purposes of 
     planning, conducting, or evaluating formulary compliance or 
     quality assurance program based on evidence based prescribing 
     or cost-containment goals;
       (C) prohibit conduct that involves the collection, use, 
     transfer, or sale of regulated records for marketing purposes 
     if--
       (i) the data involved does not contain individually 
     identifying information; and
       (ii) there is no reasonable basis to believe that the data 
     can be used to obtain individually identifying information; 
     and
       (D) prevent any person from disclosing regulated records to 
     the identified individual as long as the information does not 
     include protected information pertaining to any other person.
       (d) Regulations.--The Attorney General may promulgate 
     regulations as necessary to implement this title.
       (e) Enforcement.--Any person who knowingly fails to comply 
     with the requirements of this title, or regulations 
     promulgated pursuant to this title, by using or disclosing 
     regulated records in a manner not authorized by this title, 
     or regulations, shall be subject to an civil penalty of at 
     least $10,000, and not more than $50,000, per violation, as 
     assessed by the Attorney General. Each disclosure of a 
     regulated record shall constitute a violation of this title. 
     The Attorney General shall take necessary action to enforce 
     the payment of penalties assessed under this section.

     SEC. _04. SEVERABILITY.

       If any provision of this title, or its application to any 
     person or circumstance, is held invalid, the remainder of 
     this title, or the application of the provision, to other 
     persons or circumstances shall not be affected.

     SEC. _05. NO EFFECT ON TRUTHFUL SPEECH TO DOCTORS OR 
                   PATIENTS.

       Nothing in this title shall be construed to regulate the 
     content, time, place, or manner of any discussion between a 
     prescriber and their patient, or a prescriber and any person 
     representing a prescription drug manufacturer.
                                 ______
                                 
  SA 3132. Mrs. McCASKILL submitted an amendment intended to be 
proposed to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. 
Baucus, Mr. Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the 
Internal Revenue Code of 1986 to modify the first-time homebuyers 
credit in the case of members of the Armed Forces and certain other 
Federal employees, and for other purposes; which was ordered to lie on 
the table; as follows:

       On page 40, between lines 21 and 22, insert the following:

     SEC. 1003A. STUDY TO PROVIDE HEALTH CARE INFLATION 
                   TRANSPARENCY AND ACCOUNTABILITY.

       (a) Findings.--Congress finds the following:
       (1) Manufacturers of drugs have increased wholesale prices 
     of brand-name drugs by approximately 9 percent in the period 
     from 2008 to 2009, while all other sectors of the economy 
     experienced a 1.3 percent decline in such period.
       (2) Insurance brokers and benefits consultants predict that 
     the small business clients of such brokers and consultants 
     will experience an increase in premiums by an average of 
     approximately 15 percent for 2010, which is double the rate 
     of such increase that occurred for 2009.
       (b) Definitions.--In this section:
       (1) Health care sector.--The term ``health care sector'' 
     includes manufacturers of drugs, manufacturers of devices, 
     hospitals, insurance companies, laboratories, and health care 
     providers that are affected by this Act (and the amendments 
     made by this Act).

[[Page S12926]]

       (2) Health insurance issuer.--The term ``health insurance 
     issuer'' means those health insurance issuers subject to 
     section 2794(a) of the Public Health Service Act (as added by 
     section 1003)
       (3) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.
       (c) Annual Study.--
       (1) In general.--The Secretary, in coordination with the 
     Attorney General and the Chairman of the Federal Trade 
     Commission, shall, on an annual basis, collect and study data 
     on pricing in the health care sector. Such data shall include 
     the information provided to the Secretary under section 
     2794(b)(1)(A) of the Public Health Service Act (as added by 
     section 1003).
       (2) Initial study.--The initial such study shall be for the 
     1-year period beginning on July 1, 2009, and ending on the 
     date of the first report under subsection (e).
       (3) Subsequent studies.--Each subsequent study shall be for 
     the 1-year period following the date of the preceding report 
     under subsection (e).
       (d) Collection of Data.--Health insurance issuers and 
     entities operating within the health care sector shall 
     provide to the Secretary information on price, demographics, 
     and any other variable or factor the Secretary may deem 
     necessary to determine if premiums, retail or wholesale 
     prices, or other costs are being increased unreasonably, 
     including information about the actuarial value of the plans 
     of the issuer and the medical loss ratio of such plans.
       (e) Reports.--
       (1) In general.--Based on the annual study conducted under 
     subsection (c), the Secretary, in coordination with the 
     Attorney General and the Chairman of the Federal Trade 
     Commission, shall publish an annual report on the excess 
     price inflation in the health care sector that occurred 
     during the period described in such subsection.
       (2) Excess price inflation.--For purposes of the report, 
     the term ``excess price inflation'' shall be defined by the 
     Secretary, in consultation with the Attorney General, the 
     Director of the Congressional Budget Office, and other 
     Government experts and economists as the Secretary determines 
     appropriate.
       (f) Effect of Study and Reports.--
       (1) Reimbursement rates.--The results of the study and 
     report under this section shall be taken into account--
       (A) when reimbursement rates for Federal health programs 
     are established for the years following such report; and
       (B) by States, when making recommendations under section 
     2974(b)(1)(B) of the Public Health Service Act (as added by 
     section 1003).
       (2) Rebates.--
       (A) Health insurance issuers.--Based on a study conducted 
     under subsection (c), if insurance premiums of a health 
     insurance issuer are determined by the Secretary, in 
     coordination with the Attorney General and the Chairman of 
     the Federal Trade Commission, to meet the definition of 
     excess price inflation, such issuer shall provide to each 
     enrollee of such issuer a rebate. The amount of the rebate 
     shall be calculated using the formula described under section 
     2718(b) of the Public Health Service Act (as added by section 
     1001), except for the amount of the excess price inflation 
     shall be substituted for the amount of the premium revenues.
       (B) Health care sector entities.--Based on a study 
     conducted under subsection (c), if the Secretary determines, 
     in coordination with the Attorney General and the Chairman of 
     the Federal Trade Commission, that an entity within the 
     health care sector has increased price of goods or services 
     related to such entity's participation in the health care 
     sector, such as drugs or devices, sufficient to meet the 
     definition of excess price inflation, then such entity shall 
     pay to the Treasury the amount of the excess price inflation 
     for the purpose of deficit reduction.
       (3) Appeal of determination.--The Secretary shall establish 
     an effective appeals process under which a health insurance 
     issuer or health care entity within the health care sector 
     may appeal the determination of excess price inflation 
     described in paragraph (2). In making an appeals 
     determination, the Secretary may consult with the Attorney 
     General, the Chairman of the Federal Trade Commission, the 
     Director of the Congressional Budget Office, and other 
     Government experts and economists as the Secretary determines 
     appropriate.
       (g) Public Availability.--The Secretary shall make each 
     report under subsection (e), and the supporting data 
     describing excess price inflation in the health care sector, 
     available to the public.
                                 ______
                                 
  SA 3133. Mr. WICKER submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 2074, after line 25, add the following:

                     TITLE X--ADDITIONAL PROVISIONS

            Subtitle A--Physician Payment Update Commission

     SEC. 10001. SHORT TITLE.

       This subtitle may be cited as the ``Physician Payment 
     Update Commission Act''.

     SEC. 10002. ESTABLISHMENT OF PHYSICIAN PAYMENT UPDATE 
                   COMMISSION.

       (a) Medicare Physician Fee Schedule Update and Sunset of 
     Medicare Sustainable Growth Rate Formula.--
       (1) Update for 2010 and 2011.--Section 1848(d)(10) of the 
     Social Security Act (42 U.S.C. 1395w-4(d)(10)), as added by 
     section 3101, is amended to read as follows:
       ``(10) Update for 2010 and 2011.--
       ``(A) In general.--The update to the single conversion 
     factor established in paragraph (1)(C) for 2010 and 2011 
     shall be 0 percent.
       ``(B) No effect on computation of conversion factor for 
     2012 and subsequent years.--The conversion factor under this 
     subsection shall be computed under paragraph (1)(A) for 2012 
     and subsequent years as if subparagraph (A) had never 
     applied.''.
       (2) Sunset of medicare sustainable growth rate formula.--
     Effective January 1, 2012, subsection (f) of section 1848 of 
     the Social Security Act (42 U.S.C. 1395w-4) is repealed.
       (b) Establishment of Physician Payment Update Commission.--
       (1) In general.--There is established a commission to be 
     known as the ``Physician Payment Update Commission'' 
     (referred to in this section as the ``Commission'').
       (2) Membership.--
       (A) Composition.--The Commission shall be composed of 17 
     members appointed by the Comptroller General of the United 
     States, upon the recommendation of the majority and minority 
     leaders of the Senate and the Speaker and minority leader of 
     the House of Representatives.
       (B) Date of appointments.--Members of the Commission shall 
     be appointed not later than 2 months after the date of 
     enactment of this Act.
       (3) Qualifications.--
       (A) In general.--The membership of the Commission shall 
     include individuals with national recognition for their 
     expertise in health finance and economics, actuarial science, 
     integrated delivery systems, allopathic and osteopathic 
     medicine and other areas of health services, and other 
     related fields, who provide a mix of different professionals, 
     broad geographic representation, and a balance between urban 
     and rural representatives.
       (B) Inclusion.--The members of the Commission shall include 
     (but not be limited to) physicians and other health 
     professionals, employers, third-party payers, individuals 
     skilled in the conduct and interpretation of biomedical, 
     health services, and health economics research and technology 
     assessment. Such membership shall also include 
     representatives of consumers and the elderly.
       (C) Majority physicians and other health professionals.--
     Individuals who are physicians or other health professionals 
     shall constitute a majority of the membership of the 
     Commission.
       (4) Term; vacancies.--
       (A) Term.--A member shall be appointed for the life of the 
     Commission.
       (B) Vacancies.--A vacancy on the Commission--
       (i) shall not affect the powers of the Commission; and
       (ii) shall be filled in the same manner as the original 
     appointment was made.
       (5) Meetings.--The Commission shall meet at the call of the 
     Chairperson.
       (6) Quorum.--A majority of the members of the Commission 
     shall constitute a quorum, but a lesser number of members may 
     hold hearings.
       (7) Chairperson.--The Comptroller General shall designate a 
     member of the Commission, at the time of the appointment of 
     the member, as Chairperson.
       (c) Duties.--
       (1) Study.--The Commission shall conduct a study of all 
     matters relating to payment rates under the Medicare 
     physician fee schedule under section 1848 of the Social 
     Security Act (42 U.S.C. 1395w-4).
       (2) Recommendations.--The Commission shall develop 
     recommendations on the establishment of a new physician 
     payment system under the Medicare program that would 
     appropriately reimburse physicians by keeping pace with 
     increases in medical practice costs and providing stable, 
     positive Medicare updates.
       (3) Report.--Not later than December 1, 2010, the 
     Commission shall submit to the appropriate Committees of 
     Congress and the Medicare Payment Advisory Commission--
       (A) a detailed statement of the findings and conclusions of 
     the Commission;
       (B) the recommendations of the Commission for such 
     legislation and administrative actions as the Commission 
     considers appropriate (including proposed legislative 
     language to carry out such recommendations); and
       (C) a long-term CBO cost estimate regarding such 
     recommendations (as described under subsection (i)).
       (d) Powers.--
       (1) Hearings.--The Commission may hold such hearings, meet 
     and act at such times and places, take such testimony, and 
     receive such evidence as the Commission considers advisable 
     to carry out this section.
       (2) Information from federal agencies.--
       (A) In general.--The Commission may secure directly from a 
     Federal agency such information as the Commission considers 
     necessary to carry out this section.

[[Page S12927]]

       (B) Provision of information.--On request of the 
     Chairperson of the Commission, the head of the agency shall 
     provide the information to the Commission.
       (3) Postal services.--The Commission may use the United 
     States mails in the same manner and under the same conditions 
     as other agencies of the Federal Government.
       (e) Commission Personnel Matters.--
       (1) Compensation of members.--
       (A) In general.--Members of the Commission shall serve 
     without compensation in addition to the compensation received 
     for the services of the member as an officer or employee of 
     the Federal Government.
       (B) Travel expenses.--A member of the Commission shall be 
     allowed travel expenses, including per diem in lieu of 
     subsistence, at rates authorized for an employee of an agency 
     under subchapter I of chapter 57 of title 5, United States 
     Code, while away from the home or regular place of business 
     of the member in the performance of the duties of the 
     Commission.
       (2) Staff and support services.--
       (A) Executive director.--The Chairperson shall appoint an 
     executive director of the Commission.
       (B) Staff.--With the approval of the Commission, the 
     executive director may appoint such personnel as the 
     executive director considers appropriate.
       (C) Applicability of civil service laws.--The staff of the 
     Commission shall be appointed without regard to the 
     provisions of title 5, United States Code, governing 
     appointments in the competitive service, and shall be paid 
     without regard to the provisions of chapter 51 and subchapter 
     III of chapter 53 of such title (relating to classification 
     and General Schedule pay rates).
       (D) Experts and consultants.--With the approval of the 
     Commission, the executive director may procure temporary and 
     intermittent services under section 3109(b) of title 5, 
     United States Code.
       (f) Termination of Commission.--The Commission shall 
     terminate 30 days after the date on which the Commission 
     submits its report under subsection (c)(3).
       (g) Review and Response to Recommendations by the Medicare 
     Payment Advisory Commission.--
       (1) In general.--Not later than February 1, 2011, the 
     Medicare Payment Advisory Commission shall--
       (A) review the recommendations included in the report 
     submitted under subsection (c)(3);
       (B) examine the budget consequences of such 
     recommendations, directly or through consultation with 
     appropriate expert entities; and
       (C) submit to the appropriate Committees of Congress a 
     report on such review.
       (2) Contents of report on review of commission 
     recommendations.--The report submitted under paragraph (1)(C) 
     shall include--
       (A) if the Medicare Payment Advisory Commission supports 
     the recommendations of the Commission, the reasons for such 
     support; or
       (B) if the Medicare Payment Advisory Commission does not 
     support such recommendations, the recommendations of the 
     Medicare Payment Advisory Commission, together with an 
     explanation as to why the Medicare Payment Advisory 
     Commission does not support the recommendations of the 
     Commission.
       (h) Authorization of Appropriations.--There are authorized 
     to be appropriated such sums as may be necessary for the 
     Commission to carry out this section. Such appropriation 
     shall be payable from the Federal Supplementary Medical 
     Insurance Trust Fund under section 1841 of the Social 
     Security Act (42 U.S.C. 1395t).
       (i) Long-Term CBO Cost Estimate.--
       (1) Preparation and submission.--When the Commission 
     submits a written request to the Director of the 
     Congressional Budget Office for a long-term CBO cost estimate 
     of recommended legislation or administrative actions (as 
     described under subsection (c)(3)), the Director shall 
     prepare the estimate and have it published in the 
     Congressional Record as expeditiously as possible.
       (2) Content.--A long-term CBO cost estimate shall include--
       (A) an estimate of the cost of each provision (if 
     practicable) or group of provisions of the recommended 
     legislation or administrative actions for first fiscal year 
     it would take effect and for each of the 49 fiscal years 
     thereafter; and
       (B) a statement of any estimated future costs not reflected 
     by the estimate described in subparagraph (A).
       (3) Form.--To the extent that a long-term CBO cost estimate 
     presented in dollars is impracticable, the Director of the 
     Congressional Budget Office may instead present the estimate 
     in terms of percentages of gross domestic product, with 
     rounding to the nearest \1/10\ of 1 percent of gross domestic 
     product.
       (4) Limitations on discretionary spending.--A long-term CBO 
     cost estimate shall only consider the effects of provisions 
     affecting revenues and direct spending (as defined by the 
     Balanced Budget and Emergency Deficit Control Act of 1985), 
     and shall not assume that any changes in outlays will result 
     from limitations on, or reductions in, annual appropriations.
       (j) Expedited Consideration of Commission 
     Recommendations.--
       (1) Introduction.--
       (A) In general.--The proposed legislative language 
     contained in the report submitted pursuant to subsection 
     (c)(3) (referred to in this subsection as the ``Commission 
     bill'') shall be introduced within the first 10 calendar days 
     of the 112th Congress (or on the first session day 
     thereafter) in the House of Representatives and in the Senate 
     by the majority leader of each House of Congress, for 
     himself, the minority leader of each House of Congress, for 
     himself, or any member of the House designated by the 
     majority leader or minority leader. If the Commission bill is 
     not introduced in accordance with the preceding sentence in 
     either House of Congress, then any Member of that House may 
     introduce the Commission bill on any day thereafter. Upon 
     introduction, the Commission bill shall be referred to the 
     appropriate committees under subparagraph (B).
       (B) Committee consideration.--A Commission bill introduced 
     in either House of Congress shall be jointly referred to the 
     committee or committees of jurisdiction, which shall report 
     the bill without any revision and with a favorable 
     recommendation, an unfavorable recommendation, or without 
     recommendation, not later than 10 calendar days after the 
     date of introduction of the bill in that House. If any 
     committee fails to report the bill within that period, that 
     committee shall be automatically discharged from 
     consideration of the bill, and the bill shall be placed on 
     the appropriate calendar.
       (2) Expedited procedure.--
       (A) In the house of representatives.--
       (i) In general.--Not later than 5 days of session after the 
     date on which a Commission bill is reported or discharged 
     from all committees to which it was referred, the majority 
     leader of the House of Representatives or the majority 
     leader's designee shall move to proceed to the consideration 
     of the Commission bill. It shall also be in order for any 
     Member of the House of Representatives to move to proceed to 
     the consideration of the Commission bill at any time after 
     the conclusion of such 5-day period.
       (ii) Motion to proceed.--A motion to proceed to the 
     consideration of the Commission bill is highly privileged in 
     the House of Representatives and is not debatable. The motion 
     is not subject to amendment or to a motion to postpone 
     consideration of the Commission bill. A motion to proceed to 
     the consideration of other business shall not be in order. A 
     motion to reconsider the vote by which the motion to proceed 
     is agreed to or not agreed to shall not be in order. If the 
     motion to proceed is agreed to, the House of Representatives 
     shall immediately proceed to consideration of the Commission 
     bill without intervening motion, order, or other business, 
     and the Commission bill shall remain the unfinished business 
     of the House of Representatives until disposed of.
       (iii) Limits on debate.--Debate in the House of 
     Representatives on a Commission bill under this paragraph 
     shall not exceed a total of 100 hours, which shall be divided 
     equally between those favoring and those opposing the bill. A 
     motion further to limit debate is in order and shall not be 
     debatable. It shall not be in order to move to recommit a 
     Commission bill under this paragraph or to move to reconsider 
     the vote by which the bill is agreed to or disagreed to.
       (iv) Appeals.--Appeals from decisions of the chair relating 
     to the application of the Rules of the House of 
     Representatives to the procedure relating to a Commission 
     bill shall be decided without debate.
       (v) Application of house rules.--Except to the extent 
     specifically provided in this paragraph, consideration of a 
     Commission bill shall be governed by the Rules of the House 
     of Representatives. It shall not be in order in the House of 
     Representatives to consider any Commission bill introduced 
     pursuant to the provisions of this subsection under a 
     suspension of the rules or under a special rule.
       (vi) No amendments.--No amendment to the Commission bill 
     shall be in order in the House of Representatives.
       (vii) Vote on final passage.--In the House of 
     Representatives, immediately following the conclusion of 
     consideration of the Commission bill, the vote on final 
     passage of the Commission bill shall occur without any 
     intervening action or motion, requiring an affirmative vote 
     of \3/5\ of the Members, duly chosen and sworn. If the 
     Commission bill is passed, the Clerk of the House of 
     Representatives shall cause the bill to be transmitted to the 
     Senate before the close of the next day of session of the 
     House.
       (B) In the senate.--
       (i) In general.--Not later than 5 days of session after the 
     date on which a Commission bill is reported or discharged 
     from all committees to which it was referred, the majority 
     leader of the Senate or the majority leader's designee shall 
     move to proceed to the consideration of the Commission bill. 
     It shall also be in order for any Member of the Senate to 
     move to proceed to the consideration of the Commission bill 
     at any time after the conclusion of such 5-day period.
       (ii) Motion to proceed.--A motion to proceed to the 
     consideration of the Commission bill is privileged in the 
     Senate and is not debatable. The motion is not subject to 
     amendment or to a motion to postpone consideration of the 
     Commission bill. A motion to proceed to consideration of the 
     Commission bill may be made even though a previous motion to 
     the same effect has been disagreed to. A motion to proceed to 
     the consideration of other business shall not be in order. A 
     motion to reconsider the vote by which the motion to proceed 
     is agreed to or not agreed to shall not be in order. If the 
     motion to proceed is agreed to, the Senate shall immediately 
     proceed to consideration of the Commission bill without 
     intervening motion,

[[Page S12928]]

     order, or other business, and the Commission bill shall 
     remain the unfinished business of the Senate until disposed 
     of.
       (iii) Limits on debate.--In the Senate, consideration of 
     the Commission bill and on all debatable motions and appeals 
     in connection therewith shall not exceed a total of 100 
     hours, which shall be divided equally between those favoring 
     and those opposing the Commission bill. A motion further to 
     limit debate on the Commission bill is in order and is not 
     debatable. Any debatable motion or appeal is debatable for 
     not to exceed 1 hour, to be divided equally between those 
     favoring and those opposing the motion or appeal. All time 
     used for consideration of the Commission bill, including time 
     used for quorum calls and voting, shall be counted against 
     the total 100 hours of consideration.
       (iv) No amendments.--No amendment to the Commission bill 
     shall be in order in the Senate.
       (v) Motion to recommit.--A motion to recommit a Commission 
     bill shall not be in order under this paragraph.
       (vi) Vote on final passage.--In the Senate, immediately 
     following the conclusion of consideration of the Commission 
     bill and a request to establish the presence of a quorum, the 
     vote on final passage of the Commission bill shall occur and 
     shall require an affirmative vote of \3/5\ of the Members, 
     duly chosen and sworn.
       (vii) Other motions not in order.--A motion to postpone or 
     a motion to proceed to the consideration of other business is 
     not in order in the Senate. A motion to reconsider the vote 
     by which the Commission bill is agreed to or not agreed to is 
     not in order in the Senate.
       (viii) Consideration of the house bill.--

       (I) In general.--If the Senate has received the House 
     companion bill to the Commission bill introduced in the 
     Senate prior to the vote required under clause (vi) and the 
     House companion bill is identical to the Commission bill 
     introduced in the Senate, then the Senate shall consider, and 
     the vote under clause (vi) shall occur on, the House 
     companion bill.
       (II) Procedure after vote on senate bill.--If the Senate 
     votes, pursuant to clause (vi), on the bill introduced in the 
     Senate, the Senate bill shall be held pending receipt of the 
     House message on the bill. Upon receipt of the House 
     companion bill, if the House bill is identical to the Senate 
     bill, the House bill shall be deemed to be considered, read 
     for the third time, and the vote on passage of the Senate 
     bill shall be considered to be the vote on the bill received 
     from the House.

       (C) No suspension.--No motion to suspend the application of 
     this paragraph shall be in order in the Senate or in the 
     House of Representatives.

               Subtitle B--Medical Care Access Protection

     SEC. 10101. SHORT TITLE.

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

     SEC. 10102. FINDINGS AND PURPOSE.

       (a) Findings.--
       (1) Effect on health care access and costs.--Congress finds 
     that our current civil justice system is adversely affecting 
     patient access to health care services, better patient care, 
     and cost-efficient health care, in that the health care 
     liability system is a costly and ineffective mechanism for 
     resolving claims of health care liability and compensating 
     injured patients, and is a deterrent to the sharing of 
     information among health care professionals which impedes 
     efforts to improve patient safety and quality of care.
       (2) Effect on interstate commerce.--Congress finds that the 
     health care and insurance industries are industries affecting 
     interstate commerce and the health care liability litigation 
     systems existing throughout the United States are activities 
     that affect interstate commerce by contributing to the high 
     costs of health care and premiums for health care liability 
     insurance purchased by health care system providers.
       (3) Effect on federal spending.--Congress finds that the 
     health care liability litigation systems existing throughout 
     the United States have a significant effect on the amount, 
     distribution, and use of Federal funds because of--
       (A) the large number of individuals who receive health care 
     benefits under programs operated or financed by the Federal 
     Government;
       (B) the large number of individuals who benefit because of 
     the exclusion from Federal taxes of the amounts spent to 
     provide them with health insurance benefits; and
       (C) the large number of health care providers who provide 
     items or services for which the Federal Government makes 
     payments.
       (b) Purpose.--It is the purpose of this subtitle to 
     implement reasonable, comprehensive, and effective health 
     care liability reforms designed to--
       (1) improve the availability of health care services in 
     cases in which health care liability actions have been shown 
     to be a factor in the decreased availability of services;
       (2) reduce the incidence of ``defensive medicine'' and 
     lower the cost of health care liability insurance, all of 
     which contribute to the escalation of health care costs;
       (3) ensure that persons with meritorious health care injury 
     claims receive fair and adequate compensation, including 
     reasonable noneconomic damages;
       (4) improve the fairness and cost-effectiveness of our 
     current health care liability system to resolve disputes 
     over, and provide compensation for, health care liability by 
     reducing uncertainty in the amount of compensation provided 
     to injured individuals; and
       (5) provide an increased sharing of information in the 
     health care system which will reduce unintended injury and 
     improve patient care.

     SEC. 10103. DEFINITIONS.

       In this subtitle:
       (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 causes of 
     action, in which the claimant alleges a health care liability 
     claim.

[[Page S12929]]

       (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 subtitle, 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. 10104. 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 subtitle 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. 10105. COMPENSATING PATIENT INJURY.

       (a) Unlimited Amount of Damages for Actual Economic Losses 
     in Health Care Lawsuits.--In any health care lawsuit, nothing 
     in this subtitle 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. 10106. 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.
       (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

[[Page S12930]]

     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. 10107. 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. 10108. 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. 10109. 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 subtitle.

     SEC. 10110. 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 subtitle shall not affect the application of the 
     rule of law to such an action; and
       (B) any rule of law prescribed by this subtitle 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 subtitle or otherwise 
     applicable law (as determined under this subtitle) 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 subtitle shall not affect the application of the 
     rule of law to such an action; and
       (B) any rule of law prescribed by this subtitle 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 subtitle 
     or otherwise applicable law (as determined under this 
     subtitle) will apply to such aspect of such action.
       (c) Other Federal Law.--Except as provided in this section, 
     nothing in this subtitle 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. 10111. STATE FLEXIBILITY AND PROTECTION OF STATES' 
                   RIGHTS.

       (a) Health Care Lawsuits.--The provisions governing health 
     care lawsuits set forth in this subtitle 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 subtitle. The provisions 
     governing health care lawsuits set forth in this subtitle 
     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 subtitle; or
       (2) prohibits the introduction of evidence regarding 
     collateral source benefits.
       (b) Preemption of Certain State Laws.--No provision of this 
     subtitle shall be construed to preempt any State law (whether 
     effective before, on, or after the date of the enactment of 
     this Act) 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 subtitle, 
     notwithstanding section 10105(a).

[[Page S12931]]

       (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 subtitle 
     (including the State standards of negligence) shall be 
     governed by otherwise applicable Federal or State law.
       (2) Rule of construction.--Nothing in this subtitle 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 subtitle;
       (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 Act;
       (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. 10112. APPLICABILITY; EFFECTIVE DATE.

       This subtitle 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 Act, except that 
     any health care lawsuit arising from an injury occurring 
     prior to the date of enactment of this Act shall be governed 
     by the applicable statute of limitations provisions in effect 
     at the time the injury occurred.

            Subtitle C--Rescission of Unused Stimulus Funds

     SEC. 10201. RESCISSION IN ARRA.

       Effective as of October 1, 2010, 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.
                                 ______
                                 
  SA 3134. Mr. BURR (for himself, Mrs. Hutchison, and Mr. Wicker) 
submitted an amendment intended to be proposed to amendment SA 2786 
proposed by Mr. Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. 
Harkin) to the bill H.R. 3590, to amend the Internal Revenue Code of 
1986 to modify the first-time homebuyers credit in the case of members 
of the Armed Forces and certain other Federal employees, and for other 
purposes; which was ordered to lie on the table; as follows:

       On page 2074, after line 25 insert the following:

                     TITLE X--ADDITIONAL PROVISIONS

Subtitle A--Medicare Physician Fee Schedule Update for 2010, 2011, and 
                                  2012

     SEC. 10001. MEDICARE PHYSICIAN FEE SCHEDULE UPDATE FOR 2010, 
                   2011, AND 2012.

       Section 1848(d)(10) of the Social Security Act (42 U.S.C. 
     1395w-4(d)), as added by section 3101, is amended to read as 
     follows:
       ``(10) Update for 2010, 2011, and 2012.--
       ``(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, and 2012, the update to the 
     single conversion factor shall be 0.5 percent.
       ``(B) No effect on computation of conversion factor for 
     2013 and subsequent years.--The conversion factor under this 
     subsection shall be computed under paragraph (1)(A) for 2013 
     and subsequent years as if subparagraph (A) had never 
     applied.''.

               Subtitle B--Medical Care Access Protection

     SEC. 10101. FINDINGS AND PURPOSE.

       (a) Findings.--
       (1) Effect on health care access and costs.--Congress finds 
     that our current civil justice system is adversely affecting 
     patient access to health care services, better patient care, 
     and cost-efficient health care, in that the health care 
     liability system is a costly and ineffective mechanism for 
     resolving claims of health care liability and compensating 
     injured patients, and is a deterrent to the sharing of 
     information among health care professionals which impedes 
     efforts to improve patient safety and quality of care.
       (2) Effect on interstate commerce.--Congress finds that the 
     health care and insurance industries are industries affecting 
     interstate commerce and the health care liability litigation 
     systems existing throughout the United States are activities 
     that affect interstate commerce by contributing to the high 
     costs of health care and premiums for health care liability 
     insurance purchased by health care system providers.
       (3) Effect on federal spending.--Congress finds that the 
     health care liability litigation systems existing throughout 
     the United States have a significant effect on the amount, 
     distribution, and use of Federal funds because of--
       (A) the large number of individuals who receive health care 
     benefits under programs operated or financed by the Federal 
     Government;
       (B) the large number of individuals who benefit because of 
     the exclusion from Federal taxes of the amounts spent to 
     provide them with health insurance benefits; and
       (C) the large number of health care providers who provide 
     items or services for which the Federal Government makes 
     payments.
       (b) Purpose.--It is the purpose of this subtitle to 
     implement reasonable, comprehensive, and effective health 
     care liability reforms designed to--
       (1) improve the availability of health care services in 
     cases in which health care liability actions have been shown 
     to be a factor in the decreased availability of services;
       (2) reduce the incidence of ``defensive medicine'' and 
     lower the cost of health care liability insurance, all of 
     which contribute to the escalation of health care costs;
       (3) ensure that persons with meritorious health care injury 
     claims receive fair and adequate compensation, including 
     reasonable noneconomic damages;
       (4) improve the fairness and cost-effectiveness of our 
     current health care liability system to resolve disputes 
     over, and provide compensation for, health care liability by 
     reducing uncertainty in the amount of compensation provided 
     to injured individuals; and
       (5) provide an increased sharing of information in the 
     health care system which will reduce unintended injury and 
     improve patient care.

     SEC. 10102. DEFINITIONS.

       In this subtitle:
       (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

[[Page S12932]]

     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 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 subtitle, 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. 10103. 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 subtitle 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. 10104. COMPENSATING PATIENT INJURY.

       (a) Unlimited Amount of Damages for Actual Economic Losses 
     in Health Care Lawsuits.--In any health care lawsuit, nothing 
     in this subtitle 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. 10105. 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.

[[Page S12933]]

       (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.
       (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. 10106. 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. 10107. 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. 10108. 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 subtitle.

     SEC. 10109. 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 subtitle shall not affect the application of the 
     rule of law to such an action; and
       (B) any rule of law prescribed by this subtitle 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 subtitle or otherwise 
     applicable law (as determined under this subtitle) 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 subtitle shall not affect the application of the 
     rule of law to such an action; and
       (B) any rule of law prescribed by this subtitle 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 subtitle 
     or otherwise applicable law (as determined under this 
     subtitle) will apply to such aspect of such action.
       (c) Other Federal Law.--Except as provided in this section, 
     nothing in this subtitle 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. 10110. STATE FLEXIBILITY AND PROTECTION OF STATES' 
                   RIGHTS.

       (a) Health Care Lawsuits.--The provisions governing health 
     care lawsuits set forth in this subtitle 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 subtitle. The provisions 
     governing health care lawsuits set forth in this subtitle 
     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 subtitle; or
       (2) prohibits the introduction of evidence regarding 
     collateral source benefits.

[[Page S12934]]

       (b) Preemption of Certain State Laws.--No provision of this 
     subtitle shall be construed to preempt any State law (whether 
     effective before, on, or after the date of the enactment of 
     this Act) 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 subtitle, 
     notwithstanding section 10104(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 subtitle 
     (including the State standards of negligence) shall be 
     governed by otherwise applicable Federal or State law.
       (2) Rule of construction.--Nothing in this subtitle 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 subtitle;
       (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 Act;
       (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. 10111. APPLICABILITY; EFFECTIVE DATE.

       This subtitle 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 Act, except that 
     any health care lawsuit arising from an injury occurring 
     prior to the date of enactment of this Act shall be governed 
     by the applicable statute of limitations provisions in effect 
     at the time the injury occurred.

  Subtitle C--Rescission of Discretionary Amounts Appropriated by the 
             American Recovery and Reinvestment Act of 2009

     SEC. 10201. RESCISSION OF DISCRETIONARY AMOUNTS APPROPRIATED 
                   BY THE AMERICAN RECOVERY AND REINVESTMENT ACT 
                   OF 2009.

       (a) In General.--All discretionary amounts made available 
     by the American Recovery and Reinvestment Act of 2009 (123 
     Stat. 115; Public Law No: 111-5) that are unobligated on the 
     date of the enactment of this Act are hereby rescinded.
       (b) Administration.--Not later than 30 days after the date 
     of the enactment of this Act, the Director of the Office of 
     Management and Budget shall--
       (1) administer the reduction specified in subsection (a); 
     and
       (2) submit to the Committee on Appropriations of the Senate 
     and the Committee on Appropriations of the House of 
     Representatives a report specifying the account and the 
     amount of each reduction made pursuant to subsection (a).
                                 ______
                                 
  SA 3135. Mr. SANDERS (for himself, Mr. Brown, Mr. Franken, and Mr. 
Burris) submitted an amendment intended to be proposed to amendment SA 
2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. 
Harkin) to the bill H.R. 3590, to amend the Internal Revenue Code of 
1986 to modify the first-time homebuyers credit in the case of members 
of the Armed Forces and certain other Federal employees, and for other 
purposes; which was ordered to lie on the table; as follows:

       Beginning on page 1979, line 20, strike all through page 
     1996, line 3, and insert the following:

     SEC. 9001. SURCHARGE ON HIGH INCOME INDIVIDUALS.

       (a) In General.--Subchapter A of chapter 1 of the Internal 
     Revenue Code of 1986 is amended by adding at the end the 
     following new part:

           ``PART VIII--SURCHARGE ON HIGH INCOME INDIVIDUALS

``Sec. 59B. Surcharge on high income individuals.

     ``SEC. 59B. SURCHARGE ON HIGH INCOME INDIVIDUALS.

       ``(a) General Rule.--In the case of a taxpayer other than a 
     corporation, there is hereby imposed (in addition to any 
     other tax imposed by this subtitle) a tax equal to 5.4 
     percent of so much of the modified adjusted gross income of 
     the taxpayer as exceeds $4,800,000.
       ``(b) Taxpayers Not Making a Joint Return.--In the case of 
     any taxpayer other than a taxpayer making a joint return 
     under section 6013 or a surviving spouse (as defined in 
     section 2(a)), subsection (a) shall be applied by 
     substituting `$2,400,000' for `$4,800,000'.
       ``(c) Modified Adjusted Gross Income.--For purposes of this 
     section, the term `modified adjusted gross income' means 
     adjusted gross income reduced by any deduction (not taken 
     into account in determining adjusted gross income) allowed 
     for investment interest (as defined in section 163(d)). In 
     the case of an estate or trust, adjusted gross income shall 
     be determined as provided in section 67(e).
       ``(d) Special Rules.--
       ``(1) Nonresident alien.--In the case of a nonresident 
     alien individual, only amounts taken into account in 
     connection with the tax imposed under section 871(b) shall be 
     taken into account under this section.
       ``(2) Citizens and residents living abroad.--The dollar 
     amount in effect under subsection (a) (after the application 
     of subsection (b)) shall be decreased by the excess of--
       ``(A) the amounts excluded from the taxpayer's gross income 
     under section 911, over
       ``(B) the amounts of any deductions or exclusions 
     disallowed under section 911(d)(6) with respect to the 
     amounts described in subparagraph (A).
       ``(3) Charitable trusts.--Subsection (a) shall not apply to 
     a trust all the unexpired interests in which are devoted to 
     one or more of the purposes described in section 
     170(c)(2)(B).
       ``(4) Not treated as tax imposed by this chapter for 
     certain purposes.--The tax imposed under this section shall 
     not be treated as tax imposed by this chapter for purposes of 
     determining the amount of any credit under this chapter or 
     for purposes of section 55.''.
       (b) Clerical Amendment.--The table of parts for subchapter 
     A of chapter 1 of the Internal Revenue Code of 1986 is 
     amended by adding at the end the following new item:

         ``part viii. surcharge on high income individuals.''.

       (c) Section 15 Not to Apply.--The amendment made by 
     subsection (a) shall not be treated as a change in a rate of 
     tax for purposes of section 15 of the Internal Revenue Code 
     of 1986.
       (d) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     2010.
                                 ______
                                 
  SA 3136. Mr. UDALL of New Mexico submitted an amendment intended to 
be proposed to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. 
Baucus, Mr. Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the 
Internal Revenue Code of 1986 to modify the first-time homebuyers 
credit in the case of members of the Armed Forces and certain other 
Federal employees, and for other purposes; which was ordered to lie on 
the table; as follows:

       On page 796, between lines 5 and 6, insert the following:

           PART IV--TELEHEALTH AND REMOTE PATIENT MONITORING

     SEC. 3031. TELEHEALTH AND REMOTE PATIENT MONITORING.

       (a) Improving Credentialing and Privileging Standards for 
     Telehealth Services.--Section 1834(m) of the Social Security 
     Act (42 U.S.C. 1395m(m)) is amended by adding at the end the 
     following new paragraph:
       ``(5) Establishment of remote credentialing and privileging 
     standards.--
       ``(A) In general.--Not later than 2 years after the date of 
     the enactment of this paragraph, the Secretary shall 
     establish regulations for considering the remote 
     credentialing and privileging standards applicable to 
     telehealth services, including interpretative services, for 
     originating sites under this subsection. Such regulations 
     shall allow an originating site to accept, and not duplicate, 
     the credentialing and privileging processes and decisions 
     made by another site.
       ``(B) Clarification regarding acceptance of processes and 
     decisions prior to enactment of regulations.--During the 
     period beginning on such date of enactment and ending on the 
     effective date of the regulations under subparagraph (A), the 
     Secretary shall not take any punitive action under any rule 
     or regulation against an originating site on the basis of 
     that site's acceptance, for purposes of receiving telehealth 
     services (including interpretive services), the credentialing 
     and privileging processes and decisions made by another site 
     that is certified by a national body recognized by the 
     Secretary if the site accepting such credentialing and 
     privileging processes is also so certified and complies with 
     the applicable requirements for such acceptance.''.
       (b) Expanding Access to Stroke Telehealth Evaluation.--
       (1) In general.--Section 1834(m)(4) of the Social Security 
     Act (42 U.S.C. 1395m(m)(4)) is amended by adding at the end 
     the following new subparagraph:
       ``(G) Stroke telehealth services.--The term `stroke 
     telehealth services' means a telehealth service used for the 
     evaluation of individuals with acute stroke.''.
       (2) Effective date.--The amendment made by this subsection 
     shall apply to telehealth services furnished on or after the 
     date that is 6 months after the date of enactment of this 
     Act.
       (c) Improving Access to Telehealth Services at IHS 
     Facilities.--
       (1) Coverage of metropolitan sites.--Section 
     1834(m)(4)(C)(i) of such Act (42 U.S.C. 1395m(m)(4)(C)(i)) is 
     amended--
       (A) in subclause (II), by deleting ``or'' at the end;
       (B) in subclause (III), by deleting the period at the end 
     and inserting ``; or''; and
       (C) by adding at the end the following subclause:

       ``(IV) from a facility of the Indian Health Service 
     (whether operated by such Service or by an Indian tribe or 
     tribal organization (as

[[Page S12935]]

     those terms are defined in section 4 of the Indian Health 
     Care Improvement Act)).''.

       (2) Inclusion of ihs facilities as originating sites.--
     Section 1834(m)(4)(C)(ii) of the Social Security Act (42 
     U.S.C. 1395m(m)(4)(C)(ii)) is amended by adding at the end 
     the following new subclause:

       ``(IX) A facility of the Indian Health Service, whether 
     operated by such Service or by an Indian tribe or tribal 
     organization (as those terms are defined in section 4 of the 
     Indian Health Care Improvement Act).''.

       (3) Effective date.--The amendments made by this subsection 
     apply to telehealth services furnished on or after the date 
     that is 6 months after the date of enactment of this Act.
       (d) Community-Based Patient Monitoring.--Section 3026(B) of 
     this Act is amended by adding at the end the following new 
     clause:
       ``(vi) Utilizing telehealth, remote patient monitoring, and 
     other technology when medically appropriate to enhance care 
     transition services provided across the continuum of care.''.
       (e) Telehealth Advisory Committee.--
       (1) Establishment.--Section 1868 of the Social Security Act 
     (42 U.S.C. 1395ee) is amended--
       (A) in the heading, by adding at the end the following: 
     ``telehealth advisory committee''; and
       (B) by adding at the end the following new subsection:
       ``(c) Telehealth Advisory Committee.--
       ``(1) In general.--A Telehealth Advisory Committee (in this 
     subsection referred to as the `Advisory Committee') shall be 
     appointed by the Secretary to make annual recommendations to 
     the Secretary on policies of the Centers for Medicare & 
     Medicaid Services regarding telehealth services as 
     established under section 1834(m), including the appropriate 
     addition or deletion of services (and HCPCS codes) to those 
     specified in paragraphs (4)(F)(i) and (4)(F)(ii) of such 
     section and for authorized payment under paragraph (1) of 
     such section, and to Congress on areas in which originating 
     sites are located (as specified in paragraph (4)(C)(i) of 
     such section) and eligible telehealth sites (as described in 
     paragraph (4)(C)(ii) of such section).
       ``(2) Membership; terms.--
       ``(A) Membership.--
       ``(i) In general.--The Advisory Committee shall be composed 
     of 10 members, to be appointed by the Secretary, of whom--

       ``(I) 5 shall be practicing physicians;
       ``(II) 2 shall be practicing nonphysician health care 
     practitioners;
       ``(III) 2 shall be administrators of telehealth programs; 
     and
       ``(IV) 1 shall be an informatics or technology expert.

       ``(ii) Requirements for appointing members.--In appointing 
     members of the Advisory Committee, the Secretary shall--

       ``(I) ensure that each member has prior experience with the 
     practice of telemedicine or telehealth;
       ``(II) give preference to individuals who are currently 
     providing telemedicine or telehealth services or who are 
     involved in telemedicine or telehealth programs;
       ``(III) ensure that the membership of the Advisory 
     Committee represents a balance of specialties and geographic 
     regions; and
       ``(IV) take into account the recommendations of 
     stakeholders.

       ``(B) Terms.--The members of the Advisory Committee shall 
     serve for a 3-year term.
       ``(C) Conflicts of interest.--A member of the Advisory 
     Committee may not participate with respect to a particular 
     matter considered in a meeting of the Advisory Committee if 
     such member (or an immediate family member of such member) 
     has a financial interest that could be affected by the advice 
     given to the Secretary with respect to such matter.
       ``(D) Priority areas for consideration.--In making 
     recommendations under paragraph (1), the committee shall 
     consider recommendations to Congress on the following:
       ``(i) Increasing coverage of telehealth services to all 
     geographic areas of the United States. Such consideration 
     shall take into account the costs to the Federal Government 
     of such increased coverage and the total offsetting savings 
     accrued to the Federal Government as a result of investments 
     in telehealth.
       ``(ii) Including providing payments under section 1834(m) 
     for store and forward services for all eligible areas. Such 
     consideration should take into account the experience in 
     Alaska and Hawaii in providing such services under this 
     title, including the impact on costs, the effect on the 
     quality and availability of health services, and ways in 
     which the Federal Government can minimize the risk of fraud 
     and abuse for such services.
       ``(iii) Expanding coverage under this title of remote 
     monitoring services for--

       ``(I) individuals with chronic diseases;
       ``(II) individuals recently discharged from a facility that 
     is an originating site under such section; and
       ``(III) individuals assigned to an accountable care 
     organization under section 1899, individuals discharged from 
     a hospital that receives disproportionate share payments 
     under section 1886(d)(5)(F) who are in need of transitional 
     care, and individuals who are furnished services under the 
     national pilot program on payment bundling under section 
     1866D.

     Each recommendation made under paragraph (1) shall take into 
     consideration the costs to the Federal Government and the 
     total offsetting savings accrued to the Federal Government as 
     a result of investments in telehealth and ways in which the 
     Federal Government can minimize the risk of fraud and abuse 
     for telehealth services.
       ``(3) Requirement to review and provide recommendations.--
     The Advisory Committee shall review and provide 
     recommendations to the Secretary on legislation that would 
     allow other providers of services and suppliers to provide 
     telehealth services to Medicare beneficiaries.
       ``(4) Deadline.--Not later than December 31, 2010, the 
     Advisory Committee shall submit to Congress any 
     recommendations to Congress under paragraph (1), including 
     the recommendations considered under paragraph (2)(D).''.
       (2) Following recommendations.--Section 1834(m)(4)(F) of 
     such Act (42 U.S.C. 1395m(m)(4)(F)) is amended by adding at 
     the end the following new clause:
       ``(iii) Recommendations of the telehealth advisory 
     committee.--In making determinations under clauses (i) and 
     (ii), the Secretary shall take into account the 
     recommendations of the Telehealth Advisory Committee 
     (established under section 1868(c)) when adding or deleting 
     services (and HCPCS codes) and in establishing policies of 
     the Centers for Medicare & Medicaid Services regarding the 
     delivery of telehealth services. If the Secretary does not 
     implement such a recommendation, the Secretary shall publish 
     in the Federal Register a statement regarding the reason such 
     recommendation was not implemented.''.
       (3) Waiver of administrative limitation.--The Secretary of 
     Health and Human Services shall establish the Telehealth 
     Advisory Committee under the amendment made by paragraph (1) 
     notwithstanding any limitation that may apply to the number 
     of advisory committees that may be established (within the 
     Department of Health and Human Services or otherwise).
       (f) List of Covered Telehealth Services.--Section 
     1834(m)(4)(F) of such Act (42 U.S.C. 1395m(m)(4)(F)), as 
     amended by subsection (e), is further amended--
       (1) by redesignating clauses (ii) and (iii) as clauses 
     (iii) and (iv);
       (2) by inserting after clause (i) the following new clause:
       ``(ii) Originating site services.--

       ``(I) In general.--Subject to subclause (II), the Secretary 
     may make payments under this subsection to an originating 
     site described in subparagraph (C)(ii) for services 
     originating at the site.
       ``(II) Limitation.--The Secretary may not make such 
     payments with respect to a service described in subclause (I) 
     if the Secretary finds, upon review of the available 
     evidence, that a service is not safe, effective, or medically 
     beneficial when performed as a telehealth service.''; and

       (3) by striking clause (iii), as redesignated under 
     paragraph (1), and inserting the following new clause:
       ``(iii) Yearly update.--The Secretary shall establish a 
     process that provides, on an annual basis--

       ``(I) for the addition of telehealth services (and HCPCS 
     codes), to those specified in clauses (i) and (ii) for 
     authorized payment under this subsection, unless the 
     Secretary finds, upon review of the available evidence, that 
     a service is not safe, effective, or medically beneficial 
     when performed as a telehealth service; and
       ``(II) for the deletion of such services (and HCPCS codes), 
     from those specified in clauses (i) and (ii) for authorized 
     payment under this subsection, that the Secretary finds, upon 
     review of additional evidence, are not safe, effective, or 
     medically beneficial when performed as a telehealth 
     service.''.

       (g) Telehealth Access to Small Population Metropolitan 
     Counties.--Section 1834(m)(4)(C)(i)(II) of such Act (42 
     U.S.C. 1395m(4)(C)(i)(II)) is amended to read as follows:

       ``(II) in a county with a population of less than 35,000, 
     according to the most recent decennial census, or that is not 
     included in a Metropolitan Statistical Area; or''.

       (h) Telehealth Access for ``Store and Forward'' Diagnostic 
     Consultations.--Section 1834(m)(1) of such Act (42 U.S.C. 
     1395(m)(1)) is amended by adding at the end the following 
     sentence: ``For purposes of the first sentence, in the case 
     of telehealth services that are furnished by a facility of 
     the Indian Health Service, a rural health clinic, a Federally 
     qualified health center, or a critical access hospital (as 
     described in paragraph (4)(C)(ii)) , or a sole community 
     hospital (as defined in section 1886(d)(5)(D)(iii)), the term 
     `telecommunications system' includes store-and-forward 
     technologies described in the preceding sentence.''.
                                 ______
                                 
  SA 3137. Mr. BEGICH submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 1339, between lines 18 and 19, insert the 
     following:

[[Page S12936]]

     SEC. 5211. INCREASING ACCESS TO PRIMARY CARE SERVICES.

       (a) State Grants to Health Care Providers Who Provide 
     Services to a High Percentage of Medically Underserved 
     Populations or Other Special Populations.--
       (1) In general.--A State may award grants to health care 
     providers who treat a high percentage, as determined by such 
     State, of medically underserved populations or other special 
     populations in such State.
       (2) Source of funds.--A grant program established by a 
     State under paragraph (1) may not be established within a 
     department, agency, or other entity of such State that 
     administers the Medicaid program under title XIX of the 
     Social Security Act (42 U.S.C. 1396 et seq.), and no Federal 
     or State funds allocated to such Medicaid program, the 
     Medicare program under title XVIII of the Social Security Act 
     (42 U.S.C. 1395 et seq.), or the TRICARE program under 
     chapter 55 of title 10, United States Code, may be used to 
     award grants or to pay administrative costs associated with a 
     grant program established under paragraph (1).
       (b) Providing for Underserved Medicare Populations 
     Demonstration Project.--Subpart III of part D of title III of 
     the Public Health Service Act (42 U.S.C. 254l et seq.) is 
     amended by adding at the end the following:

     ``SEC. 338N. PROVIDING FOR UNDERSERVED MEDICARE POPULATIONS 
                   DEMONSTRATION PROJECT.

       ``(a) In General.--The Secretary shall establish, in not 
     more than 5 States, a demonstration project, to be known as 
     the Providing for Underserved Medicare Populations 
     Demonstration Project, for the purpose of encouraging health 
     care providers who are recent graduates of a health care 
     program to enter into primary care practice, by providing 
     incentive payments to eligible primary health services 
     providers.
       ``(b) Demonstration Project.--
       ``(1) In general.--The Secretary shall grant awards, on a 
     competitive basis, to eligible primary health services 
     providers, as described in paragraph (2). Each recipient of 
     such an award shall receive such award for a period of 3 
     years, provided such recipient continues to meet the 
     eligibility criteria described in subsection (c).
       ``(2) Award amounts.--Each award described in paragraph (1) 
     shall be in an amount not to exceed--
       ``(A) $50,000 per year for the repayment of student loans 
     associated with the health care educational expenses of such 
     recipient; or
       ``(B) $37,500 per year in cash incentive payments.
       ``(c) Eligible Primary Health Services Providers.--The 
     Secretary shall establish criteria for individuals to be 
     eligible to receive an award under this section, which shall 
     include requirements that such individual--
       ``(1) be actively employed as a primary health services 
     provider, or have arrangements to commence active employment 
     as a primary health services provider, in one of the 5 States 
     that the Secretary has selected for participation in this 
     demonstration project and in a community with a population of 
     not less than 35,000 and not more than 350,000 and not 
     designated as a health professional shortage area;
       ``(2) have graduated, not more than 2 years after the date 
     on which such individual would begin receiving incentive 
     payments under this project, from an accredited program that 
     qualifies such individual to maintain employment as a primary 
     health services provider;
       ``(3) agree that, of the patients receiving care from such 
     primary health services provider in the period during which 
     such individual participates in the project, not less than 60 
     percent of such patients shall be enrolled in the Medicare 
     program under title XVIII of the Social Security Act;
       ``(4) be employed, as described in paragraph (1), in a 
     State in which the 65-and-over population is expected to grow 
     at least 50 percent between 2010 and 2020, according to 
     United States Census Bureau projections; and
       ``(5) meet such other eligibility criteria established by 
     the Secretary.
       ``(d) Duration of Program.--The Secretary shall make 
     initial awards to individuals under this section for each of 
     fiscal years 2011 through 2013.
       ``(e) Report.--Not later than December 31, 2015, the 
     Secretary shall submit to Congress a report concerning the 
     results of the demonstration project.
       ``(f) Authorization of Appropriations.--To carry out this 
     section, there are authorized to be appropriated $25,000,000 
     for fiscal years 2011 through 2015.''.
       (c) Faculty Loan Repayment for Physician Assistants.--
     Section 738(a)(3) of the Public Health Service Act (42 
     U.S.C.293b(a)(3)) is amended by inserting ``schools offering 
     physician assistant education programs,'' after ``public 
     health,''.
       (d) National Health Service Corps.--
       (1) Fulfillment of obligated service requirement through 
     half-time service.--
       (A) Waivers.--Subsection (i) of section 331 (42 U.S.C. 
     254d) is amended--
       (i) in paragraph (1), by striking ``In carrying out subpart 
     III'' and all that follows through the period and inserting 
     ``In carrying out subpart III, the Secretary may, in 
     accordance with this subsection, issue waivers to individuals 
     who have entered into a contract for obligated service under 
     the Scholarship Program or the Loan Repayment Program under 
     which the individuals are authorized to satisfy the 
     requirement of obligated service through providing clinical 
     practice that is half time.'';
       (ii) in paragraph (2)--

       (I) in subparagraphs (A)(ii) and (B), by striking ``less 
     than full time'' each place it appears and inserting ``half 
     time'';
       (II) in subparagraphs (C) and (F), by striking ``less than 
     full-time service'' each place it appears and inserting 
     ``half-time service''; and
       (III) by amending subparagraphs (D) and (E) to read as 
     follows:

       ``(D) the entity and the Corps member agree in writing that 
     the Corps member will perform half-time clinical practice;
       ``(E) the Corps member agrees in writing to fulfill all of 
     the service obligations under section 338C through half-time 
     clinical practice and either--
       ``(i) double the period of obligated service that would 
     otherwise be required; or
       ``(ii) in the case of contracts entered into under section 
     338B, accept a minimum service obligation of 2 years with an 
     award amount equal to 50 percent of the amount that would 
     otherwise be payable for full-time service; and''; and
       (iii) in paragraph (3), by striking ``In evaluating a 
     demonstration project described in paragraph (1)'' and 
     inserting ``In evaluating waivers issued under paragraph 
     (1)''.
       (B) Definitions.--Subsection (j) of section 331 (42 U.S.C. 
     254d) is amended by adding at the end the following:
       ``(5) The terms `full time' and `full-time' mean a minimum 
     of 40 hours per week in a clinical practice, for a minimum of 
     45 weeks per year.
       ``(6) The terms `half time' and `half-time' mean a minimum 
     of 20 hours per week (not to exceed 39 hours per week) in a 
     clinical practice, for a minimum of 45 weeks per year.''.
       (2) Reappointment to national advisory council.--Section 
     337(b)(1) (42 U.S.C. 254j(b)(1)) is amended by striking 
     ``Members may not be reappointed to the Council.''.
       (3) Loan repayment amount.--Section 338B(g)(2)(A) (42 
     U.S.C. 254l-1(g)(2)(A)) is amended by striking ``$35,000'' 
     and inserting ``$50,000, plus, beginning with fiscal year 
     2012, an amount determined by the Secretary on an annual 
     basis to reflect inflation,''.
       (4) Treatment of teaching as obligated service.--Subsection 
     (a) of section 338C (42 U.S.C. 254m) is amended by adding at 
     the end the following: ``The Secretary may treat teaching as 
     clinical practice for up to 20 percent of such period of 
     obligated service.''.
                                 ______
                                 
  SA 3138. Mrs. HUTCHISON (for herself and Mr. Hatch) submitted an 
amendment intended to be proposed to amendment SA 2786 proposed by Mr. 
Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the bill 
H.R. 3590, to amend the Internal Revenue Code of 1986 to modify the 
first-time homebuyers credit in the case of members of the Armed Forces 
and certain other Federal employees, and for other purposes; which was 
ordered to lie on the table; as follows:

       Strike sections 2551 and 3133.
                                 ______
                                 
  SA 3139. Mrs. HUTCHISON submitted an amendment intended to be 
proposed to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. 
Baucus, Mr. Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the 
Internal Revenue Code of 1986 to modify the first-time homebuyers 
credit in the case of members of the Armed Forces and certain other 
Federal employees, and for other purposes; which was ordered to lie on 
the table; as follows:

       On page 354, between lines 2 and 3, insert the following:
       (D) Exemption for employers in states with high premium 
     increases.--
       (i) In general.--If a State is described in clause (ii), 
     then, on and after the certification date, no employer in 
     such State shall be treated as an applicable large employer 
     for purposes of this section.
       (ii) State described.--For purposes of this subparagraph--

       (I) In general.--A State is described in this clause if the 
     applicable State authority determines for any calendar year 
     after 2013 that the percentage increase in average annual 
     premiums for health insurance coverage in such State for the 
     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.
       (II) Certification date.--The term ``certification date'' 
     means the first date on which the applicable State authority 
     certifies a determination described in subclause (I).
       (III) 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 3140. Mrs. HUTCHISON submitted an amendment intended to be 
proposed to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. 
Baucus, Mr. Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the 
Internal Revenue Code of 1986 to modify the first-time homebuyers 
credit in the case of members of the Armed Forces and certain

[[Page S12937]]

other Federal employees, and for other purposes; which was ordered to 
lie on the table; as follows:

       On page 339, between lines 16 and 17, insert the following:
       ``(g) Limitation.--
       ``(1) In general.--This section shall not apply to any 
     individual residing in a State where the Secretary makes the 
     determination described in paragraph (2) for a taxable year.
       ``(2) Determination.--A determination described in this 
     paragraph is a determination that the average cost of 
     premiums for health insurance coverage within the State for 
     the year involved has increase by a percentage that is 
     greater than the percentage increase in the Consumer Price 
     Index for the year.''.
                                 ______
                                 
  SA 3141. Mrs. HUTCHISON submitted an amendment intended to be 
proposed to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. 
Baucus, Mr. Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the 
Internal Revenue Code of 1986 to modify the first-time homebuyers 
credit in the case of members of the Armed Forces and certain other 
Federal employees, and for other purposes; which was ordered to lie on 
the table; as follows:

       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 in a 
     medically underserved community, 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) in a medically 
     underserved community.
       (9) Health care lawsuit.--The term ``health care lawsuit'' 
     means any health care liability claim concerning the 
     provision of health care goods or services in a medically 
     underserved community, 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 who delivers services 
     in a medically underserved community or a health care 
     institution located in a medically underserved community 
     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 who 
     delivers services in a medically underserved community or a 
     health care institution located in a medically underserved 
     community 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, 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 who 
     delivers services in a medically underserved community or a 
     health care institution located in a medically underserved 
     community, 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) Medically underserved community.--The term ``medically 
     underserved community'' means a health manpower shortage area 
     as designated under section 332 of the Public Health Service 
     Act.
       (15) 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.
       (16) 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 who delivers services in a medically 
     underserved community or a health care institution located in 
     a medically underserved community. Punitive damages are 
     neither economic nor noneconomic damages.
       (17) 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.
       (18) 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.

[[Page S12938]]

     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.
       (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

[[Page S12939]]

     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
       (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 3142. Mrs. HUTCHISON submitted an amendment intended to be 
proposed to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. 
Baucus, Mr. Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the 
Internal Revenue Code of 1986 to modify the first-time homebuyers 
credit in the case of members of the Armed Forces and certain other 
Federal employees, and for other purposes; which was ordered to lie on 
the table; as follows:

       On page 2026, strike line 3 and insert the following:
       (i) Exclusion of Devices for Cancer Diagnosis and 
     Treatment.--
       (1) In general.--The term ``medical device sales'' shall 
     not include sales of any device which is primarily designed 
     to diagnose or treat any form of cancer.
       (2) Reduction of aggregate fee amount.--The $2,000,000,000 
     amount in subsection (b)(1) shall be reduced by the amount 
     which bears the same ratio to such $2,000,000,000 amount as 
     the amount of the sales of devices described in paragraph (1) 
     for calendar year 2010 bears to the amount of total medical 
     device sales (without regard to this subsection) for such 
     calendar year, as determined by the Secretary.
       (j) Application of Section.--This section shall
                                 ______
                                 
  SA 3143. Mrs. HUTCHISON submitted an amendment intended to be 
proposed to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. 
Baucus, Mr. Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the 
Internal Revenue Code of 1986 to modify the first-time homebuyers 
credit in the case of members of the Armed Forces and certain

[[Page S12940]]

other Federal employees, and for other purposes; which was ordered to 
lie on the table; as follows:

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

     SEC. __. STATE OPT OUT.

       (a) In General.--The provisions described in subsection (b) 
     shall not apply to
       (1) individuals residing within a State;
       (2) employers located within a State; and
       (3) health coverage offered within a State;
     if the State enacts a law rejecting such provisions as 
     described in subsection (b) and attests to the Secretary that 
     the State will implement reforms appropriate for application 
     within the State to reduce the uninsured population of the 
     State and increase access to affordable health insurance 
     options.
       (b) Effect of State Law.--The provisions described in this 
     subsection are the following:
       (1) The insurance market reform provisions of title I (and 
     the amendments made by such title), except for section 2704 
     of the Public Health Service Act (as added by section 1201 
     (relating to preexisting condition exclusions).
       (2) The requirements relating to obtaining or providing 
     individual and employer health insurance coverage under title 
     I (and the amendments made by such title).
       (3) The provisions relating to Medicaid expansion under the 
     amendments made by title I.
       (4) The provisions relating to the Medicare program (and 
     the amendments to such program) under title III and (IV).
       (5) The provisions relating to the imposition of, or 
     increases in, fees paid by insurance issuers and drug and 
     medical device manufacturers under the amendments made by 
     this Act.
       (6) Any other provision of this Act (or an amendment made 
     by this Act), except for this section.
       (c) Above-the-Line Deduction for Health Insurance 
     Premiums.--
       (1) In general.--Section 62(a) of the Internal Revenue Code 
     of 1986 (defining adjusted gross income) is amended by 
     inserting after paragraph (21) the following new paragraph:
       ``(22) Health insurance payments.--
       ``(A) In general.--Any amount allowable as a deduction 
     under section 213 (determined without regard to any income 
     limitation under subsection (a) thereof) by reason of 
     subsection (d)(1)(D) thereof for qualified health insurance.
       ``(B) Qualified health insurance.--For purposes of this 
     paragraph--
       ``(i) In general.--The term `qualified health insurance' 
     means insurance offered to individuals located in a State 
     that enacts a law described in section __(a) of the Patient 
     Protection and Affordable Care Act which constitutes medical 
     care as defined in section 213(d) without regard to--

       ``(I) paragraph (1)(C) thereof, and
       ``(II) so much of paragraph (1)(D) thereof as relates to 
     qualified long-term care insurance contracts.

       ``(ii) Exclusion of certain other contracts.--Such term 
     shall not include insurance if a substantial portion of its 
     benefits are excepted benefits (as defined in section 
     9832(c)).''.
       (2) Effective date.--The amendment made by this subsection 
     shall apply to taxable years beginning after December 31, 
     2009.
                                 ______
                                 
  SA 3144. Mr. FRANKEN submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

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

     SEC. __. ANTI-FRAUD CONSULTATION GROUP.

       (a) Establishment.--The Secretary of Health and Human 
     Services jointly with the Attorney General shall establish an 
     anti-fraud consultation group for the purpose of coordinating 
     expertise and best practices relating to the analysis, 
     detection, and prevention of fraud, waste, and abuse arising 
     from, or related to, health care.
       (b) Composition.--The anti-fraud consultation group under 
     subsection (a) shall be composed of individuals, to be 
     appointed jointly by the Secretary of Health and Human 
     Services and the Attorney General, with expertise from both 
     the public and private sectors in fraud arising from, or 
     related to, health care, including law enforcement personnel, 
     health insurance issuers, physicians and other health care 
     providers, insurance anti-fraud organizations, academic 
     experts, consumer groups, and insurance regulators.
       (c) Duties.--At the request of the Secretary of Health and 
     Human Services and the Attorney General, the anti-fraud 
     consultation group under subsection (a) shall provide advice 
     concerning--
       (1) methods of preventing fraud against Federal and State 
     health care programs, consumers, providers, employers, and 
     health insurance issuers;
       (2) the evaluation of information and data to improve the 
     ability to detect and prevent fraud;
       (3) the enhancement of anti-fraud information data systems, 
     consistent with the protection of personal privacy; and
       (4) the coordination of public and private resources in the 
     analysis, detection, and prevention of fraud arising from, or 
     related to, health care.
       (d) Annual Report.--The anti-fraud consultation group under 
     subsection (a) shall, not later than 1 year after the date of 
     enactment of this Act, and annually thereafter, submit to the 
     Secretary of Health and Human Services and the Attorney 
     General a report concerning the group's--
       (1) accomplishments to improve the coordination of public 
     and private health care antifraud actions;
       (2) development of enhanced techniques for the analysis, 
     detection, and prevention of fraud; and
       (3) recommendations for the improvement of anti-fraud 
     programs.
       (e) Funding.--The Secretary and the Attorney General shall 
     use funds appropriated to the Secretary or Attorney General 
     prior to the date of enactment of this Act, and otherwise 
     available, to carry out this section.
                                 ______
                                 
  SA 3145. Mr. McCONNELL (for himself, Mr. Ensign, and Mr. McCain) 
submitted an amendment intended to be proposed to amendment SA 2786 
proposed by Mr. Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. 
Harkin) to the bill H.R. 3590, to amend the Internal Revenue Code of 
1986 to modify the first-time homebuyers credit in the case of members 
of the Armed Forces and certain other Federal employees, and for other 
purposes; which was ordered to lie on the table; as follows:

       In lieu of the matter proposed to be inserted, insert the 
     following:

     SECTION 1. SHORT TITLE.

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

     SEC. 2. FINDINGS AND PURPOSE.

       (a) Findings.--
       (1) Effect on health care access and costs.--Congress finds 
     that our current civil justice system is adversely affecting 
     patient access to health care services, better patient care, 
     and cost-efficient health care, in that the health care 
     liability system is a costly and ineffective mechanism for 
     resolving claims of health care liability and compensating 
     injured patients, and is a deterrent to the sharing of 
     information among health care professionals which impedes 
     efforts to improve patient safety and quality of care.
       (2) Effect on interstate commerce.--Congress finds that the 
     health care and insurance industries are industries affecting 
     interstate commerce and the health care liability litigation 
     systems existing throughout the United States are activities 
     that affect interstate commerce by contributing to the high 
     costs of health care and premiums for health care liability 
     insurance purchased by health care system providers.
       (3) Effect on federal spending.--Congress finds that the 
     health care liability litigation systems existing throughout 
     the United States have a significant effect on the amount, 
     distribution, and use of Federal funds because of--
       (A) the large number of individuals who receive health care 
     benefits under programs operated or financed by the Federal 
     Government;
       (B) the large number of individuals who benefit because of 
     the exclusion from Federal taxes of the amounts spent to 
     provide them with health insurance benefits; and
       (C) the large number of health care providers who provide 
     items or services for which the Federal Government makes 
     payments.
       (b) Purpose.--It is the purpose of this Act to implement 
     reasonable, comprehensive, and effective health care 
     liability reforms designed to--
       (1) improve the availability of health care services in 
     cases in which health care liability actions have been shown 
     to be a factor in the decreased availability of services;
       (2) reduce the incidence of ``defensive medicine'' and 
     lower the cost of health care liability insurance, all of 
     which contribute to the escalation of health care costs;
       (3) ensure that persons with meritorious health care injury 
     claims receive fair and adequate compensation, including 
     reasonable noneconomic damages;
       (4) improve the fairness and cost-effectiveness of our 
     current health care liability system to resolve disputes 
     over, and provide compensation for, health care liability by 
     reducing uncertainty in the amount of compensation provided 
     to injured individuals; and
       (5) provide an increased sharing of information in the 
     health care system which will reduce unintended injury and 
     improve patient care.

     SEC. 3. DEFINITIONS.

       In this Act:
       (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

[[Page S12941]]

     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 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 Act, 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. 4. 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 Act 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. 5. COMPENSATING PATIENT INJURY.

       (a) Unlimited Amount of Damages for Actual Economic Losses 
     in Health Care Lawsuits.--In any health care lawsuit, nothing 
     in this Act 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.--

[[Page S12942]]

       (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. 6. 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.
       (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. 7. 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. 8. 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''

[[Page S12943]]

     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. 9. 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 Act.

     SEC. 10. 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 Act shall not affect the application of the rule 
     of law to such an action; and
       (B) any rule of law prescribed by this Act 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 Act or otherwise 
     applicable law (as determined under this Act) 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 Act shall not affect the application of the rule 
     of law to such an action; and
       (B) any rule of law prescribed by this Act 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 Act or 
     otherwise applicable law (as determined under this Act) will 
     apply to such aspect of such action.
       (c) Other Federal Law.--Except as provided in this section, 
     nothing in this Act 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. 11. STATE FLEXIBILITY AND PROTECTION OF STATES' RIGHTS.

       (a) Health Care Lawsuits.--The provisions governing health 
     care lawsuits set forth in this Act 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 Act. The provisions governing 
     health care lawsuits set forth in this Act 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 Act; or
       (2) prohibits the introduction of evidence regarding 
     collateral source benefits.
       (b) Preemption of Certain State Laws.--No provision of this 
     Act shall be construed to preempt any State law (whether 
     effective before, on, or after the date of the enactment of 
     this Act) 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 Act, notwithstanding 
     section 5(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 Act (including 
     the State standards of negligence) shall be governed by 
     otherwise applicable Federal or State law.
       (2) Rule of construction.--Nothing in this Act 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 Act;
       (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 Act;
       (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. 12. APPLICABILITY; EFFECTIVE DATE.

       This Act 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 Act, except that any health 
     care lawsuit arising from an injury occurring prior to the 
     date of enactment of this Act shall be governed by the 
     applicable statute of limitations provisions in effect at the 
     time the injury occurred.
                                 ______
                                 
  SA 3146. Mr. BARRASSO submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 340, between lines 14 and 15, insert the following:
       ``(g) 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 3147. Mr. BARRASSO submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 339, between lines 12 and 13, insert 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 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 3148. Mr. BARRASSO submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 396, between lines 8 and 9, insert the following:

[[Page S12944]]

          Subtitle H--Sunset if Premiums Increase Too Rapidly

     SEC. 1601. SUNSET.

       (a) In General.--The following requirements 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 this title, 
     section 2707 of the Public Health Service Act, or any other 
     provision of, or amendment made by, this title that a health 
     plan provide an essential health benefits package described 
     in section 1302(a) of this title, including any requirement 
     that the plan provide--
       (A) for essential health benefits described in section 
     1302(b);
       (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); and
       (C) a level of coverage described in section 1302(d).
       (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 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 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 3149. Mr. BARRASSO submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 999, between lines 16 and 17, insert the following:
       (q) Budget-Neutral Exemption of Certain Providers.--
     Notwithstanding the provisions of, and amendments made by, 
     the preceding subsections of this section--
       (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 3150. Mr. BARRASSO submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 186, strike line 23 and insert the following: 
     ``plan. When establishing geographically adjusted premium 
     rates under the preceding sentence, the Secretary shall not 
     take into account direct graduate medical education payments, 
     Medicare disproportionate share payments, and health 
     information technology funding under the American Recovery 
     and Reinvestment Act of 2009.''.
                                 ______
                                 
  SA 3151. Mr. BARRASSO submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 201, between lines 6 and 7, insert the following:

     SEC. 1325. PROHIBITION ON FEDERAL BAILOUT OF A CO-OP PLAN OR 
                   A COMMUNITY HEALTH INSURANCE OPTION.

       (a) Prohibition.--Notwithstanding any provision of (or 
     amendment made by) this Act, no Federal funds shall paid to, 
     or used to support the operation of (including ensuring the 
     solvency of), a qualified health plan offered under the 
     Consumer Operated and Oriented Plan (CO-OP) program under 
     section 1322 or a community health insurance option under 
     section 1323.
       (b) Exceptions.--Subsection (a) shall not apply to--
       (1) loans and grants under section 1322(b) or loans or 
     payments under section 1323(c); or
       (2) any premium tax credit under section 36B of the 
     Internal Revenue Code of 1986 or any cost-sharing reduction 
     under section 1402, or any advance payment of either, with 
     respect to an individual enrolled in a plan or option 
     described in subsection (a).
                                 ______
                                 
  SA 3152. Mr. ENSIGN submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the appropriate place, insert the following:

                TITLE __--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

[[Page S12945]]

     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 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. INCREASED FMAP FOR MEDICAL LIABILITY REFORM.

       With respect to fiscal years 2011 and 2012, the Secretary 
     of Health and Human Services shall increase by an amount 
     equal to 2 percent of the total amount of Federal payments 
     estimated to be made to a State under section 1903(a)(1) of 
     the Social Security Act (42 U.S.C. 1396b(a)(1)) for providing 
     medical assistance for children under the State Medicaid 
     program during the fiscal year if the Secretary determines 
     that the State has enacted a law that substantially complies 
     with this title.

     SEC. _4. 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. _5. 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

[[Page S12946]]

       (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. _6. 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.
       (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. _7. 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. _8. 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. _9. 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. _10. 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

[[Page S12947]]

     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. _11. 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
       (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 _5(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. _12. 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 3153. Mr. BARRASSO submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 339, between lines 16 and 17, insert 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 3154. Mr. BARRASSO submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 2034, strike lines 8 through 15.
                                 ______
                                 
  SA 3155. Mr. BARRASSO submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 201, between lines 6 and 7, insert the following:

     SEC. 1325. ANNUAL AUDITS.

       (a) In General.--The Secretary shall enter into contracts 
     with one or more private accounting firms for the conduct of 
     annual audits of the CO-OP program under section 1322 and the 
     community health insurance option program under section 1323. 
     SUch contracts shall require that such firms submit annual 
     reports to the Secretary concerning the results of such 
     audits.
       (b) Inclusion in Medicare Trustees Report.--Sections 
     1817(b) and 1841(b) of the Social Security Act (42 U.S.C. 
     1395i(b); 1395t(b)) are each amended by inserting at the end 
     the following new sentence: ``Each report submitted under 
     paragraph (2) (beginning with the report for 2014) shall 
     include a description of the results of the audits conducted 
     under section 1325(a) of the Patient Protection and 
     Affordable Care Act for the year involved.''.
                                 ______
                                 
  SA 3156. Mr. LAUTENBERG (for himself, Mr. Carper, and Mr. Menendez) 
submitted an amendment intended to be proposed to amendment SA 2786 
proposed by Mr. Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. 
Harkin) to the bill H.R. 3590, to amend the Internal Revenue Code of 
1986 to modify the first-time homebuyers credit in the case of members 
of the Armed Forces and certain other Federal employees, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the end, add the following:

               TITLE X--IMPORTATION OF PRESCRIPTION DRUGS

     SEC. 10001. SHORT TITLE.

       This title may be cited as the ``Pharmaceutical Market 
     Access and Drug Safety Act of 2009''.

     SEC. 10002. 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. 10003. 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.

     SEC. 10004. 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 10003, 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

[[Page S12948]]

     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 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)

[[Page S12949]]

     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 
     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),

[[Page S12950]]

     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 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.

[[Page S12951]]

       ``(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:

       ``(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

[[Page S12952]]

     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 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).

[[Page S12953]]

       ``(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.
       ``(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

[[Page S12954]]

     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 10004(e) of the Pharmaceutical Market Access and Drug 
     Safety Act of 2009, 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 
     (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.

[[Page S12955]]

       ``(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 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.--

[[Page S12956]]

       (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 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

[[Page S12957]]

     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 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. 10005. 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 10004, 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. 10006. 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.

[[Page S12958]]

       ``(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 10004.
       (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 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. 10007. 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

[[Page S12959]]

     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).
       ``(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. 10008. 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

[[Page S12960]]

     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 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. 10009. 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

[[Page S12961]]

     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. 10010. 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.

     SEC. 10011. CERTIFICATION.

       (a) In General.--This title (other than this section), and 
     the amendments made by this title, shall become effective 
     only if the Secretary of Health and Human Services certifies 
     to Congress that the implementation of this title, and the 
     amendments made by this title, will--
       (1) pose no additional risk to the public's health and 
     safety; and
       (2) result in a significant reduction in the cost of 
     covered products to the American consumer.
       (b) Effective Date.--Notwithstanding any other provision of 
     this title, or of any amendment made by this title--
       (1) any reference in this title, or in such amendments, to 
     the date of enactment of this title shall be deemed to be a 
     reference to the date of the certification under subsection 
     (a); and
       (2) each reference to ``January 1, 2012'' in section 
     10006(c) shall be substituted with ``90 days after the 
     effective date of this title''.
                                 ______
                                 
  SA 3157. Mrs. SHAHEEN (for herself, and Mr. Merkley) submitted an 
amendment intended to be proposed to amendment SA 2786 proposed by Mr. 
Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the bill 
H.R. 3590, to amend the Internal Revenue Code of 1986 to modify the 
first-time homebuyers credit in the case of members of the Armed Forces 
and certain other Federal employees, and for other purposes; which was 
ordered to lie on the table; as follows:

       On page 1703, between lines 4 and 5, insert the following:

     SEC. 6303. IMPROVEMENTS TO COMPARATIVE CLINICAL EFFECTIVENESS 
                   RESEARCH.

       Section 1181 of the Social Security Act (as added by 
     section 6301) is amended--
       (1) in subsection (d)(2)(B)--
       (A) in clause (ii)(IV)--
       (i) by inserting ``, as described in subparagraph 
     (A)(ii),'' after ``original research''; and
       (ii) by inserting ``, as long as the researcher enters into 
     a data use agreement with the Institute for use of the data 
     from the original research, as appropriate'' after 
     ``publication''; and
       (B) by amending clause (iv) to read as follows:
       ``(iv) Subsequent use of the data.--The Institute shall not 
     allow the subsequent use of data from original research in 
     work-for-hire contracts with individuals, entities, or 
     instrumentalities that have a financial interest in the 
     results, unless approved under a data use agreement with the 
     Institute.'';
       (2) in subsection (d)(8)(A)(iv), by striking ``not be 
     construed as mandates for'' and inserting ``do not include''; 
     and
       (3) in subsection (f)(1)(C), by amending clause (ii) to 
     read as follows:
       ``(ii) 5 members representing physicians and providers, 
     including 3 members representing physicians (at least 1 of 
     whom is a surgeon), 1 of whom is either a nurse or a State-
     licensed integrative health care practitioner, and 1 of whom 
     is a representative of a hospital.''.
                                 ______
                                 
  SA 3158. Mr. KYL submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end, insert the following:

                      TITLE_--PROVIDING TAX EQUITY

     Subtitle A--Use of Health Savings Accounts for Non-Group High 
                    Deductible Health Plan Premiums

     SEC. _001. USE OF HEALTH SAVINGS ACCOUNTS FOR NON-GROUP HIGH 
                   DEDUCTIBLE HEALTH PLAN PREMIUMS.

       (a) In General.--Section 223(d)(2)(C) of the Internal 
     Revenue Code of 1986 (relating to exceptions) is amended by 
     striking ``or'' at the end of clause (iii), by striking the 
     period at the end of clause (iv) and inserting ``, or'', and 
     by adding at the end the following new clause:
       ``(v) a high deductible health plan, other than a group 
     health plan (as defined in section 5000(b)(1)).''.
       (b) Effective Date.--The amendment made by this section 
     shall apply to taxable years beginning after December 31, 
     2009.

               Subtitle B--Medical Care Access Protection

     SEC. _101. SHORT TITLE.

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

     SEC. _102. FINDINGS AND PURPOSE.

       (a) Findings.--
       (1) Effect on health care access and costs.--Congress finds 
     that our current civil justice system is adversely affecting 
     patient access to health care services, better patient care, 
     and cost-efficient health care, in that the health care 
     liability system is a costly and ineffective mechanism for 
     resolving claims of health care liability and compensating 
     injured patients, and is a deterrent to the sharing of 
     information among health care professionals which impedes 
     efforts to improve patient safety and quality of care.
       (2) Effect on interstate commerce.--Congress finds that the 
     health care and insurance industries are industries affecting 
     interstate commerce and the health care liability litigation 
     systems existing throughout the United States are activities 
     that affect interstate commerce by contributing to the high 
     costs of health care and premiums for health care liability 
     insurance purchased by health care system providers.
       (3) Effect on federal spending.--Congress finds that the 
     health care liability litigation systems existing throughout 
     the United States have a significant effect on the amount, 
     distribution, and use of Federal funds because of--
       (A) the large number of individuals who receive health care 
     benefits under programs operated or financed by the Federal 
     Government;
       (B) the large number of individuals who benefit because of 
     the exclusion from Federal taxes of the amounts spent to 
     provide them with health insurance benefits; and
       (C) the large number of health care providers who provide 
     items or services for which the Federal Government makes 
     payments.
       (b) Purpose.--It is the purpose of this subtitle to 
     implement reasonable, comprehensive, and effective health 
     care liability reforms designed to--
       (1) improve the availability of health care services in 
     cases in which health care liability actions have been shown 
     to be a factor in the decreased availability of services;
       (2) reduce the incidence of ``defensive medicine'' and 
     lower the cost of health care liability insurance, all of 
     which contribute to the escalation of health care costs;
       (3) ensure that persons with meritorious health care injury 
     claims receive fair and adequate compensation, including 
     reasonable noneconomic damages;
       (4) improve the fairness and cost-effectiveness of our 
     current health care liability system to resolve disputes 
     over, and provide compensation for, health care liability by 
     reducing uncertainty in the amount of compensation provided 
     to injured individuals; and
       (5) provide an increased sharing of information in the 
     health care system which will reduce unintended injury and 
     improve patient care.

     SEC. _103. DEFINITIONS.

       In this subtitle:
       (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

[[Page S12962]]

     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 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 subtitle, 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. _104. 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 subtitle 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. _105. COMPENSATING PATIENT INJURY.

       (a) Unlimited Amount of Damages for Actual Economic Losses 
     in Health Care Lawsuits.--In any health care lawsuit, nothing 
     in this subtitle 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

[[Page S12963]]

     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. _106. 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.
       (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. _107. 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. _108. 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. _109. 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 subtitle.

     SEC. _110. 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 subtitle shall not affect the application of the 
     rule of law to such an action; and
       (B) any rule of law prescribed by this subtitle 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 subtitle or otherwise 
     applicable law (as determined under this subtitle) 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

[[Page S12964]]

     establishes a Federal rule of law applicable to a civil 
     action brought for a smallpox vaccine-related injury or 
     death--
       (A) this subtitle shall not affect the application of the 
     rule of law to such an action; and
       (B) any rule of law prescribed by this subtitle 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 subtitle 
     or otherwise applicable law (as determined under this 
     subtitle) will apply to such aspect of such action.
       (c) Other Federal Law.--Except as provided in this section, 
     nothing in this subtitle 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. _111. STATE FLEXIBILITY AND PROTECTION OF STATES' 
                   RIGHTS.

       (a) Health Care Lawsuits.--The provisions governing health 
     care lawsuits set forth in this subtitle 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 subtitle. The provisions 
     governing health care lawsuits set forth in this subtitle 
     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 subtitle; or
       (2) prohibits the introduction of evidence regarding 
     collateral source benefits.
       (b) Preemption of Certain State Laws.--No provision of this 
     subtitle shall be construed to preempt any State law (whether 
     effective before, on, or after the date of the enactment of 
     this Act) 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 subtitle, 
     notwithstanding section _105(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 subtitle 
     (including the State standards of negligence) shall be 
     governed by otherwise applicable Federal or State law.
       (2) Rule of construction.--Nothing in this subtitle 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 subtitle;
       (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 Act;
       (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. _112. APPLICABILITY; EFFECTIVE DATE.

       This subtitle 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 Act, except that 
     any health care lawsuit arising from an injury occurring 
     prior to the date of enactment of this Act shall be governed 
     by the applicable statute of limitations provisions in effect 
     at the time the injury occurred.
                                 ______
                                 
  SA 3159. Mr. KYL submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end, insert the following:

                    TITLE K_--HSA CONTRIBUTION LIMIT

             Subtitle A--Increase in HSA Contribution Limit

     SEC. _001. INCREASE IN LIMIT FOR HSA CONTRIBUTIONS TO EQUAL 
                   MAXIMUM HIGH DEDUCTIBLE HEALTH PLAN OUT-OF-
                   POCKET LIMIT.

       (a) In General.--Section 223(b)(2) of the Internal Revenue 
     Code of 1986 (relating to exceptions) is amended--
       (1) by striking ``$2,250'' in subparagraph (A) and 
     inserting ``the dollar amount specified under subsection 
     (c)(2)(A)(ii)(I) for such taxable year'', and
       (2) by striking ``$4,500'' in subparagraph (B) and 
     inserting ``the dollar amount specified under subsection 
     (c)(2)(A)(ii)(II) for such taxable year''.
       (b) Effective Date.--The amendment made by this section 
     shall apply to months beginning after the date of the 
     enactment of this Act.

               Subtitle B--Medical Care Access Protection

     SEC. _101. SHORT TITLE.

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

     SEC. _102. FINDINGS AND PURPOSE.

       (a) Findings.--
       (1) Effect on health care access and costs.--Congress finds 
     that our current civil justice system is adversely affecting 
     patient access to health care services, better patient care, 
     and cost-efficient health care, in that the health care 
     liability system is a costly and ineffective mechanism for 
     resolving claims of health care liability and compensating 
     injured patients, and is a deterrent to the sharing of 
     information among health care professionals which impedes 
     efforts to improve patient safety and quality of care.
       (2) Effect on interstate commerce.--Congress finds that the 
     health care and insurance industries are industries affecting 
     interstate commerce and the health care liability litigation 
     systems existing throughout the United States are activities 
     that affect interstate commerce by contributing to the high 
     costs of health care and premiums for health care liability 
     insurance purchased by health care system providers.
       (3) Effect on federal spending.--Congress finds that the 
     health care liability litigation systems existing throughout 
     the United States have a significant effect on the amount, 
     distribution, and use of Federal funds because of--
       (A) the large number of individuals who receive health care 
     benefits under programs operated or financed by the Federal 
     Government;
       (B) the large number of individuals who benefit because of 
     the exclusion from Federal taxes of the amounts spent to 
     provide them with health insurance benefits; and
       (C) the large number of health care providers who provide 
     items or services for which the Federal Government makes 
     payments.
       (b) Purpose.--It is the purpose of this subtitle to 
     implement reasonable, comprehensive, and effective health 
     care liability reforms designed to--
       (1) improve the availability of health care services in 
     cases in which health care liability actions have been shown 
     to be a factor in the decreased availability of services;
       (2) reduce the incidence of ``defensive medicine'' and 
     lower the cost of health care liability insurance, all of 
     which contribute to the escalation of health care costs;
       (3) ensure that persons with meritorious health care injury 
     claims receive fair and adequate compensation, including 
     reasonable noneconomic damages;
       (4) improve the fairness and cost-effectiveness of our 
     current health care liability system to resolve disputes 
     over, and provide compensation for, health care liability by 
     reducing uncertainty in the amount of compensation provided 
     to injured individuals; and
       (5) provide an increased sharing of information in the 
     health care system which will reduce unintended injury and 
     improve patient care.

     SEC. _103. DEFINITIONS.

       In this subtitle:
       (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

[[Page S12965]]

     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 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 subtitle, 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. _104. 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 subtitle 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. _105. COMPENSATING PATIENT INJURY.

       (a) Unlimited Amount of Damages for Actual Economic Losses 
     in Health Care Lawsuits.--In any health care lawsuit, nothing 
     in this subtitle 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

[[Page S12966]]

     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. _106. 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.
       (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. _107. 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. _108. 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. _109. 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 subtitle.

     SEC. _110. 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 subtitle shall not affect the application of the 
     rule of law to such an action; and
       (B) any rule of law prescribed by this subtitle 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

[[Page S12967]]

     under title XXI of the Public Health Service Act does not 
     apply, then this subtitle or otherwise applicable law (as 
     determined under this subtitle) 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 subtitle shall not affect the application of the 
     rule of law to such an action; and
       (B) any rule of law prescribed by this subtitle 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 subtitle 
     or otherwise applicable law (as determined under this 
     subtitle) will apply to such aspect of such action.
       (c) Other Federal Law.--Except as provided in this section, 
     nothing in this subtitle 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. _111. STATE FLEXIBILITY AND PROTECTION OF STATES' 
                   RIGHTS.

       (a) Health Care Lawsuits.--The provisions governing health 
     care lawsuits set forth in this subtitle 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 subtitle. The provisions 
     governing health care lawsuits set forth in this subtitle 
     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 subtitle; or
       (2) prohibits the introduction of evidence regarding 
     collateral source benefits.
       (b) Preemption of Certain State Laws.--No provision of this 
     subtitle shall be construed to preempt any State law (whether 
     effective before, on, or after the date of the enactment of 
     this Act) 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 subtitle, 
     notwithstanding section _105(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 subtitle 
     (including the State standards of negligence) shall be 
     governed by otherwise applicable Federal or State law.
       (2) Rule of construction.--Nothing in this subtitle 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 subtitle;
       (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 Act;
       (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. _112. APPLICABILITY; EFFECTIVE DATE.

       This subtitle 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 Act, except that 
     any health care lawsuit arising from an injury occurring 
     prior to the date of enactment of this Act shall be governed 
     by the applicable statute of limitations provisions in effect 
     at the time the injury occurred.
                                 ______
                                 
  SA 3160. Mr. BEGICH submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

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

     SEC. 4208. INTERAGENCY TASK FORCE TO ASSESS AND IMPROVE 
                   ACCESS TO HEALTH CARE IN THE STATE OF ALASKA.

       (a) Establishment.--There is established a task force to be 
     known as the ``Interagency Access to Health Care in Alaska 
     Task Force'' (referred to in this section as the ``Task 
     Force'').
       (b) Duties.--The Task Force shall--
       (1) assess access to health care for beneficiaries of 
     Federal health care systems in Alaska; and
       (2) develop a strategy for the Federal Government to 
     improve delivery of health care to Federal beneficiaries in 
     the State of Alaska.
       (c) Membership.--The Task Force shall be comprised of 
     Federal members who shall be appointed, not later than 45 
     days after the date of enactment of this Act, as follows:
       (1) The Secretary of Health and Human Services shall 
     appoint one representative of each of the following:
       (A) The Department of Health and Human Services.
       (B) The Centers for Medicare and Medicaid Services.
       (C) The Indian Health Service.
       (2) The Secretary of Defense shall appoint one 
     representative of the TRICARE Management Activity.
       (3) The Secretary of the Army shall appoint one 
     representative of the Army Medical Department.
       (4) The Secretary of the Air Force shall appoint one 
     representative of the Air Force, from among officers at the 
     Air Force performing medical service functions.
       (5) The Secretary of Veterans Affairs shall appoint one 
     representative of each of the following:
       (A) The Department of Veterans Affairs.
       (B) The Veterans Health Administration.
       (6) The Secretary of Homeland Security shall appoint one 
     representative of the United States Coast Guard.
       (d) Chairperson.--One chairperson of the Task Force shall 
     be appointed by the Secretary at the time of appointment of 
     members under subsection (c), selected from among the members 
     appointed under paragraph (1).
       (e) Meetings.--The Task Force shall meet at the call of the 
     chairperson.
       (f) Report.--Not later than 180 days after the date of 
     enactment of this Act, the Task Force shall submit to 
     Congress a report detailing the activities of the Task Force 
     and containing the findings, strategies, recommendations, 
     policies, and initiatives developed pursuant to the duty 
     described in subsection (b)(2). In preparing such report, the 
     Task Force shall consider completed and ongoing efforts by 
     Federal agencies to improve access to health care in the 
     State of Alaska.
       (g) Termination.--The Task Force shall be terminated on the 
     date of submission of the report described in subsection (f).
                                 ______
                                 
  SA 3161. Mr. THUNE submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 101, between lines 19 and 20, insert the following:
       (3) Inclusion of high deductible health plans in certain 
     states.--
       (A) In general.--If a State is described in subparagraph 
     (B) with respect to health plans offered in the individual or 
     small group market, then, on and after the certification 
     date--
       (i) a health plan described in subparagraph (C) shall be 
     treated as a qualified health plan under this section, and as 
     minimum essential coverage under section 5000A of such Code, 
     for purposes of this Act and the amendments made by this Act; 
     and
       (ii) no requirement imposed by any provision of, or any 
     amendment made by, this Act shall apply with respect to such 
     plan or issuer thereof.
       (B) State described.--For purposes of this paragraph--
       (i) In general.--A State is described in this subparagraph 
     with respect to the individual or small group market within 
     the State if the applicable State authority determines for 
     any calendar year after 2013 that the percentage increase in 
     average annual premiums for health insurance coverage in such 
     market for the 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.
       (ii) Certification date.--The term ``certification date'' 
     means the first date on which the applicable State authority 
     certifies a determination described in clause (i).
       (iii) 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.
       (C) High deductible health plan.--A health plan is 
     described in this subparagraph if the plan is a high 
     deductible health plan (as defined in section 223(c)(2) of 
     the Internal Revenue Code of 1986) that meets all 
     requirements under such section to be offered in connection 
     with a health savings account.
                                 ______
                                 
  SA 3162. Mr. SPECTER (for himself and Mrs. Hagan) submitted an 
amendment intended to be proposed to amendment SA 2786 proposed by Mr. 
Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the bill 
H.R. 3590, to amend the Internal Revenue Code of 1986 to modify the 
first-time homebuyers credit in the case of members of the Armed Forces 
and certain

[[Page S12968]]

other Federal employees, and for other purposes; which was ordered to 
lie on the table; as follows:

       On page 1925, between lines 14 and 15, insert the 
     following:

 Subtitle C--Provisions Relating to the Safety of Drugs and Biological 
                                Products

     SEC. 7201. ENSURING THE SAFETY OF DRUGS AND BIOLOGICAL 
                   PRODUCTS CONTAINING BLOOD, BLOOD COMPONENTS, 
                   AND BLOOD DERIVATIVES.

       Section 351 of the Public Health Service Act (42 U.S.C. 
     262), as amended by section 7002, is further amended by 
     adding at the end the following:
       ``(m) Blood, Blood Components, and Blood Derivatives.--
       ``(1) Regulation and licensure.--The Secretary shall issue 
     regulations that--
       ``(A) require a person seeking approval of any drug or 
     licensure of a biological product that contains blood, blood 
     components, or blood derivatives to--
       ``(i) submit an application for licensure pursuant to this 
     section; and
       ``(ii) demonstrate the clinical safety, purity, and potency 
     of such drug or product; and
       ``(B) provide analytical methods and standards to evaluate 
     the quality of the blood, blood components, or blood 
     derivatives contained in the new drug or biological product 
     throughout the manufacturing process.
       ``(2) Biological products and drug products containing 
     blood, blood components, or blood derivatives.--A drug or 
     biological product described in paragraph (1) that contains 
     blood, blood components, or blood derivatives shall include 
     any drug or biological product that includes an active or 
     inactive ingredient that--
       ``(A) contains blood, blood components, or blood 
     derivatives and has the potential to--
       ``(i) transmit infectious agents, such as of a prion or a 
     microbial origin; or
       ``(ii) cause an adverse immune reaction due to the presence 
     of blood, blood components, or blood derivatives; and
       ``(B) is--
       ``(i) essential to the manufacture of the drug or product;
       ``(ii) determinate of the absorption and distribution of 
     the drug or product when administered; and
       ``(iii) essential to the safety and efficacy of the drug or 
     product.
       ``(3) Other products containing blood, blood products, or 
     blood derivatives.--In addition to the drugs and biological 
     products that meet the criteria described in paragraph (2), 
     the Secretary may issue regulations to include other products 
     containing blood, blood products, or blood derivatives as 
     biological products subject to paragraph (1).
       ``(4) Consistency of definitions.--Notwithstanding any 
     other provision of this Act or the Federal Food, Drug, and 
     Cosmetic Act, after the date of enactment of the Patient 
     Protection and Affordable Care Act, a drug or biological 
     product that has been approved under section 505 of the 
     Federal Food, Drug, and Cosmetic Act and that meets the 
     criteria described in paragraph (2) shall be treated by the 
     Secretary as a biological product approved under a biologics 
     license application under this section.''.
                                 ______
                                 
  SA 3163. Mr. SPECTER submitted an amendment intended to be proposed 
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

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

     SEC. 3143. REVISION TO PAYMENT FOR CONSULTATION CODES.

       (a) Temporary Delay of Elimination of Payment for 
     Consultation Codes.--Notwithstanding any other provision of 
     law, the Secretary of Health and Human Services shall not, 
     prior to January 1, 2011, implement any provision contained 
     in a final rule that eliminates or discontinues payment for 
     consultation codes under the physician fee schedule and part 
     B of title XVIII of the Social Security Act.
       (b) Evaluation Period.--During the period prior to January 
     1, 2011, the Secretary of Health and Human Services shall 
     consult with the Current Procedural Terminology Editorial 
     Panel of the American Medical Association for the purpose of 
     developing proposals to--
       (1) modify existing consultation codes or establish new 
     consultation codes to more accurately reflect the value 
     provided through such consultation services; and
       (2) minimize coding errors.

                          ____________________