I 111th CONGRESS 1st Session H. R. 4038 IN THE HOUSE OF REPRESENTATIVES November 6, 2009 Mr. Camp (for himself, Mr. Boehner, Mr. Cantor, Mr. Pence, Mr. McCotter, Mr. Carter, Mr. Sessions, Mr. McCarthy of California, Mr. Blunt, Mr. Kline of Minnesota, Mr. Barton of Texas, Mr. Dreier, Mr. Herger, Mr. Tiberi, Mr. Davis of Kentucky, Mr. Sam Johnson of Texas, Mr. Boustany, Mr. Scalise, Mr. Brady of Texas, Mr. Reichert, Mr. Roskam, Mr. Linder, Mr. Stearns, and Mr. Buyer) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To take meaningful steps to lower health care costs and increase access to health insurance coverage without raising taxes, cutting Medicare benefits for seniors, adding to the national deficit, intervening in the doctor-patient relationship, or instituting a government takeover of health care.

1.

Short title; purpose; table of contents

(a)

Short title

This Act may be cited as the Common Sense Health Care Reform and Affordability Act. (b)

Purpose

The purpose of this Act is to take meaningful steps to lower health care costs and increase access to health insurance coverage (especially for individuals with preexisting conditions) without— (1)raising taxes; (2)cutting Medicare benefits for seniors; (3)adding to the national deficit; (4)intervening in the doctor-patient relationship; or (5)instituting a government takeover of health care. (c)

Table of contents

The table of contents of this Act is as follows: Sec. 1. Short title; purpose; table of contents. Division A—Making Health Care Coverage Affordable for Every American Title I—Ensuring coverage for individuals with preexisting conditions and multiple health care needs Sec. 101. Establish universal access programs to improve high risk pools and reinsurance markets. Sec. 102. Elimination of certain requirements for guaranteed availability in individual market. Sec. 103. No annual or lifetime spending caps. Sec. 104. Preventing unjust cancellation of insurance coverage. Title II—Reducing health care premiums and the number of uninsured Americans Sec. 111. State innovation programs. Sec. 112. Health plan finders. Sec. 113. Administrative simplification. Division B—Improving Access to Health Care Title I—Expanding Access and Lowering Costs for Small Businesses Sec. 201. Rules governing association health plans. Sec. 202. Clarification of treatment of single employer arrangements. Sec. 203. Enforcement provisions relating to association health plans. Sec. 204. Cooperation between Federal and State authorities. Sec. 205. Effective date and transitional and other rules. Title II—Targeted Efforts to Expand Access Sec. 211. Extending coverage of dependents. Sec. 212. Allowing auto-enrollment for employer sponsored coverage. Title III—Expanding Choices by Allowing Americans to Buy Health Care Coverage Across State Lines Sec. 221. Interstate purchasing of health insurance. Title IV—Improving Health Savings Accounts Sec. 231. Saver’s credit for contributions to health savings accounts. Sec. 232. HSA funds for premiums for high deductible health plans. Sec. 233. Requiring greater coordination between HDHP administrators and HSA account administrators so that enrollees can enroll in both at the same time. Sec. 234. Special rule for certain medical expenses incurred before establishment of account. Division C—Enacting Real Medical Liability Reform Sec. 301. Encouraging speedy resolution of claims. Sec. 302. Compensating patient injury. Sec. 303. Maximizing patient recovery. Sec. 304. Additional health benefits. Sec. 305. Punitive damages. Sec. 306. Authorization of payment of future damages to claimants in health care lawsuits. Sec. 307. Definitions. Sec. 308. Effect on other laws. Sec. 309. State flexibility and protection of states’ rights. Sec. 310. Applicability; effective date. Division D—Protecting the Doctor-Patient Relationship Sec. 401. Rule of construction. Sec. 402. Repeal of Federal Coordinating Council for Comparative Effectiveness Research. Division E—Incentivizing Wellness and Quality Improvements Sec. 501. Incentives for prevention and wellness programs. Division F—Protecting Taxpayers Sec. 601. Provide full funding to HHS OIG and HCFAC. Sec. 602. Prohibiting taxpayer funded abortions and conscience protections. Sec. 603. Improved enforcement of the Medicare and Medicaid secondary payer provisions. Sec. 604. Strengthen Medicare provider enrollment standards and safeguards. Sec. 605. Tracking banned providers across State lines. Division G—Pathway for Biosimilar Biological Products Sec. 701. Licensure pathway for biosimilar biological products. Sec. 702. Fees relating to biosimilar biological products. Sec. 703. Amendments to certain patent provisions.

A

Making Health Care Coverage Affordable for Every American

B

Improving Access to Health Care

C

Enacting Real Medical Liability Reform

301.

Encouraging speedy resolution of claims

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. In no event shall the time for commencement of a health care lawsuit exceed 3 years after the date of manifestation of injury unless tolled for any of the following— (1)upon proof of 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. Actions by a minor shall be commenced within 3 years from the date of the alleged manifestation of injury except that actions by a minor under the full age of 6 years shall be commenced within 3 years of manifestation of injury or prior to the minor’s 8th birthday, 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 organization have committed fraud or collusion in the failure to bring an action on behalf of the injured minor.

302.

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 a claimant’s recovery of the full amount of the available economic damages, notwithstanding the limitation in subsection (b). (b)

Additional Noneconomic Damages

In any health care lawsuit, the amount of noneconomic damages, if available, 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 injury. (c)

No Discount of Award for Noneconomic Damages

For purposes of applying the limitation in subsection (b), future noneconomic damages shall not be discounted to present value. The jury shall not be informed about the maximum award for noneconomic damages. An award for noneconomic damages in excess of $250,000 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. If separate awards are rendered for past and future noneconomic damages and the combined awards exceed $250,000, 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. Whenever a judgment of liability is rendered as to any party, 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.

303.

Maximizing patient recovery

(a)

Court Supervision of Share of Damages Actually Paid to Claimants

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. In particular, 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. In no event shall the total of all contingent fees for representing all claimants in a health care lawsuit exceed the following limits: (1)40 percent of the first $50,000 recovered by the claimant(s). (2)331/3 percent of the next $50,000 recovered by the claimant(s). (3)25 percent of the next $500,000 recovered by the claimant(s). (4)15 percent of any amount by which the recovery by the claimant(s) is in excess of $600,000. (b)

Applicability

The limitations in this section shall apply whether the recovery is by judgment, settlement, mediation, arbitration, or any other form of alternative dispute resolution. 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. The requirement for court supervision in the first two sentences of subsection (a) applies only in civil actions.

304.

Additional health benefits

In any health care lawsuit involving injury or wrongful death, any party may introduce evidence of collateral source benefits. If a party elects to introduce such evidence, any opposing party may introduce evidence of any amount paid or contributed or reasonably likely to be paid or contributed in the future by or on behalf of the opposing party to secure the right to such collateral source benefits. No provider of collateral source benefits shall recover any amount against the claimant or receive any lien or credit against the claimant’s recovery or be equitably or legally subrogated to the right of the claimant in a health care lawsuit involving injury or wrongful death. This section shall apply to any health care lawsuit that is settled as well as a health care lawsuit that is resolved by a fact finder. This section shall not apply to section 1862(b) (42 U.S.C. 1395y(b)) or section 1902(a)(25) (42 U.S.C. 1396a(a)(25)) of the Social Security Act.

305.

Punitive damages

(a)

In General

Punitive damages may, if otherwise permitted by 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. In any health care lawsuit where no judgment for compensatory damages is rendered against such person, no punitive damages may be awarded with respect to the claim in such 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. At the request of any party in a health care lawsuit, the trier of fact shall consider in a separate proceeding— (1)whether punitive damages are to be awarded and the amount of such award; and (2)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.(b)

Determining Amount of Punitive Damages

(1)

Factors considered

In determining the amount of punitive damages, if awarded, in a health care lawsuit, 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, if awarded, in a health care lawsuit may be as much as $250,000 or as much as two times the amount of economic damages awarded, whichever is greater. The jury shall not be informed of this limitation.

306.

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 any health care lawsuit, the court may be guided by 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.

307.

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. The term compensatory damages 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 lawsuit

The term health care lawsuit means any health care liability claim concerning the provision of health care goods or services or any medical product affecting interstate commerce, or any health care liability action concerning the provision of health care goods or services or any medical product affecting interstate commerce, brought in a State or Federal court or pursuant to an alternative dispute resolution system, against a health care provider, a health care organization, or the manufacturer, distributor, supplier, marketer, promoter, or seller of a medical product, 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. Such term does not include a claim or action which is based on criminal liability; which seeks civil fines or penalties paid to Federal, State, or local government; or which is grounded in antitrust. (8)

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, a health care organization, or the manufacturer, distributor, supplier, marketer, promoter, or seller of a medical product, 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. (9)

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, health care organization, or the manufacturer, distributor, supplier, marketer, promoter, or seller of a medical product, including, but not limited to, 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 or medical products, 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. (10)

Health care organization

The term health care organization means any person or entity which is obligated to provide or pay for health benefits under any health plan, including any person or entity acting under a contract or arrangement with a health care organization to provide or administer any health benefit. (11)

Health care provider

The term health care provider means any person or entity required by State or Federal laws or regulations 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. (12)

Health care goods or services

The term health care goods or services means any goods or services provided by a health care organization, provider, or by any individual working under the supervision of a health care provider, that relates to the diagnosis, prevention, or treatment of any human disease or impairment, or the assessment or care of the health of human beings. (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)

Medical product

The term medical product means a drug, device, or biological product intended for humans, and the terms drug, device, and biological product 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(g)(1) and (h)) and section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), respectively, including any component or raw material used therein, but excluding health care services. (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, health care organization, or a manufacturer, distributor, or supplier of a medical product. 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.

308.

Effect on other laws

(a)

Vaccine Injury

(1)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 does 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)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)

Other Federal Law

Except as provided in this section, nothing in this title shall be deemed to affect any defense available to a defendant in a health care lawsuit or action under any other provision of Federal law.

309.

State flexibility and protection of states’ rights

(a)

Health Care Lawsuits

The provisions governing health care lawsuits set forth in this title 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, or mandates or permits subrogation or a lien on collateral source benefits. (b)

Protection of States’ Rights and Other Laws

(1)Any issue that is not governed by any provision of law established by or under this title (including State standards of negligence) shall be governed by otherwise applicable State or Federal law. (2)This title shall not preempt or supersede any State or Federal law that imposes greater procedural or substantive protections for health care providers and health care organizations from liability, loss, or damages than those provided by this title or create a cause of action. (c)

State Flexibility

No provision of this title shall be construed to preempt— (1)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 title, notwithstanding section 302(a); or (2)any defense available to a party in a health care lawsuit under any other provision of State or Federal law.

310.

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

D

Protecting the Doctor-Patient Relationship

401.

Rule of construction

Nothing in this Act shall be construed to interfere with the doctor-patient relationship or the practice of medicine.

402.

Repeal of Federal Coordinating Council for Comparative Effectiveness Research

Effective on the date of the enactment of this Act, section 804 of the American Recovery and Reinvestment Act of 2009 is repealed.

E

Incentivizing Wellness and Quality Improvements

501.

Incentives for prevention and wellness programs

(a)

Employee Retirement Income Security Act of 1974 limitation on exception for wellness programs under HIPAA discrimination rules

(1)

In general

Section 702(b)(2) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1182(b)(2)) is amended by adding after and below subparagraph (B) the following: In applying subparagraph (B), a group health plan (or a health insurance issuer with respect to health insurance coverage) may vary premiums and cost-sharing by up to 50 percent of the value of the benefits under the plan (or coverage) based on participation in a standards-based wellness program.. (2)

Effective date

The amendment made by paragraph (1) shall apply to plan years beginning more than 1 year after the date of the enactment of this Act. (b)

Conforming amendments to PHSA

(1)

Group market rules

(A)

In general

Section 2702(b)(2) of the Public Health Service Act (42 U.S.C. 300gg–1(b)(2)) is amended by adding after and below subparagraph (B) the following: In applying subparagraph (B), a group health plan (or a health insurance issuer with respect to health insurance coverage) may vary premiums and cost-sharing by up to 50 percent of the value of the benefits under the plan (or coverage) based on participation in a standards-based wellness program.. (B)

Effective date

The amendment made by subparagraph (A) shall apply to plan years beginning more than 1 year after the date of the enactment of this Act. (2)

Individual market rules relating to guaranteed availability

(A)

In general

Section 2741(f) of the Public Health Service Act (42 U.S.C. 300gg–1(b)(2)) is amended by adding after and below paragraph (1) the following: In applying paragraph (2), a health insurance issuer may vary premiums and cost-sharing under health insurance coverage by up to 50 percent of the value of the benefits under the coverage based on participation in a standards-based wellness program.. (B)

Effective date

The amendment made by paragraph (1) shall apply to health insurance coverage offered or renewed on and after the date that is 1 year after the date of the enactment of this Act. (c)

Conforming amendments to IRC

(1)

In general

Section 9802(b)(2) of the Internal Revenue Code of 1986 is amended by adding after and below subparagraph (B) the following: In applying subparagraph (B), a group health plan (or a health insurance issuer with respect to health insurance coverage) may vary premiums and cost-sharing by up to 50 percent of the value of the benefits under the plan (or coverage) based on participation in a standards-based wellness program.. (2)

Effective date

The amendment made by paragraph (1) shall apply to plan years beginning more than 1 year after the date of the enactment of this Act.

F

Protecting Taxpayers

601.

Provide full funding to HHS OIG and HCFAC

(a)

HCFAC funding

Section 1817(k)(3)(A) of the Social Security Act (42 U.S.C. 1395i(k)(3)(A)) is amended— (1)in clause (i)— (A)in subclause (IV), by striking 2009, and 2010 and inserting and 2009; and (B)by amending subclause (V) to read as follows: (V)for each fiscal year after fiscal year 2009, $300,000,000. ; and (2)in clause (ii)— (A)in subclause (IX), by striking 2009, and 2010 and inserting and 2009; and (B)in subclause (X), by striking 2010 and inserting 2009 and by inserting before the period at the end the following: , plus the amount by which the amount made available under clause (i)(V) for fiscal year 2010 exceeds the amount made available under clause (i)(IV) for 2009. (b)

OIG funding

There are authorized to be appropriated for each of fiscal years 2010 through 2019 $100,000,000 for the Office of the Inspector General of the Department of Health and Human Services for fraud prevention activities under the Medicare and Medicaid programs.

602.

Prohibiting taxpayer funded abortions and conscience protections

Title 1 of the United States Code is amended by adding at the end the following new chapter: 4

Prohibiting taxpayer funded abortions and conscience protections

301.

Prohibition on funding for abortions

No funds authorized or appropriated by federal law, and none of the funds in any trust fund to which funds are authorized or appropriated by federal law, shall be expended for any abortion.

302.

Prohibition on funding for health benefits plans that cover abortion

None of the funds authorized or appropriated by federal law, and none of the funds in any trust fund to which funds are authorized or appropriated by federal law, shall be expended for a health benefits plan that includes coverage of abortion.

303.

Treatment of abortions related to rape, incest, or preserving the life of the mother

The limitations established in sections 301 and 302 shall not apply to an abortion— (1)if the pregnancy is the result of an act of rape or incest; or (2)in the case where a woman suffers from a physical disorder, physical injury, or physical illness that would, as certified by a physician, place the woman in danger of death unless an abortion is performed, including a life-endangering physical condition caused by or arising from the pregnancy itself.

304.

Construction relating to supplemental coverage

Nothing in this chapter shall be construed as prohibiting any individual, entity, or State or locality from purchasing separate supplemental abortion plan or coverage that includes abortion so long as such plan or coverage is paid for entirely using only funds not authorized or appropriated by federal law and such plan or coverage shall not be purchased using matching funds required for a federally subsidized program, including a State’s or locality’s contribution of Medicaid matching funds.

305.

Construction relating to the use of non-Federal funds for health coverage

Nothing in this chapter shall be construed as restricting the ability of any managed care provider or other organization from offering abortion coverage or the ability of a State to contract separately with such a provider or organization for such coverage with funds not authorized or appropriated by federal law and such plan or coverage shall not be purchased using matching funds required for a federally subsidized program, including a State’s or locality’s contribution of Medicaid matching funds.

306.

No government discrimination against certain health care entities

(a)

In general

No funds authorized or appropriated by federal law may be made available to a Federal agency or program, or to a State or local government, if such agency, program, or government subjects any institutional or individual health care entity to discrimination on the basis that the health care entity does not provide, pay for, provide coverage of, or refer for abortions. (b)

Health care entity defined

For purposes of this section, the term health care entity includes an individual physician or other health care professional, a hospital, a provider-sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization, or plan.

.

603.

Improved enforcement of the Medicare and Medicaid secondary payer provisions

(a)

Medicare

(1)

In general

The Secretary, in coordination with the Inspector General of the Department of Health and Human Services, shall provide through the Coordination of Benefits Contractor for the identification of instances where the Medicare program should be, but is not, acting as a secondary payer to an individual’s private health benefits coverage under section 1862(b) of the Social Security Act (42 U.S.C. 1395y(b)). (2)

Updating procedures

The Secretary shall update procedures for identifying and resolving credit balance situations which occur under the Medicare program when payment under such title and from other health benefit plans exceed the providers’ charges or the allowed amount. (3)

Report on improved enforcement

Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit a report to Congress on progress made in improved enforcement of the Medicare secondary payer provisions, including recoupment of credit balances. (b)

Medicaid

Section 1903 of the Social Security Act (42 U.S.C. 1396b) is amended by adding at the end the following new subsection: (aa)

Enforcement of payer of last resort provisions

(1)

Submission of state plan amendment

Each State shall submit, not later than 1 year after the date of the enactment of this subsection, a State plan amendment that details how the State will become fully compliant with the requirements of section 1902(a)(25). (2)

Bonus for compliance

If a State submits a timely State plan amendment under paragraph (1) that the Secretary determines provides for full compliance of the State with the requirements of section 1902(a)(25), the Secretary shall provide for an additional payment to the State of $1,000,000. If a State certifies, to the Secretary’s satisfaction, that it is already fully compliant with such requirements, such amount shall be increased to $2,000,000. (3)

Reduction for noncompliance

If a State does not submit such an amendment, the Secretary shall reduce the Federal medical assistance percentage otherwise applicable under this title by 1 percentage point until the State submits such an amendment. (4)

Ongoing reduction

If at any time the Secretary determines that a State is not in compliance with section 1902(a)(25), regardless of the status of the State’s submission of a State plan amendment under this subsection or previous determinations of compliance such requirements, the Secretary shall reduce the Federal medical assistance percentage otherwise applicable under this title for the State by 1 percentage point during the period of non-compliance as determined by the Secretary. .

604.

Strengthen Medicare provider enrollment standards and safeguards

(a)

Protecting against the fraudulent use of Medicare provider numbers

Subject to subsection (c)(2)— (1)

Screening new providers

As a condition of a provider of services or a supplier, including durable medical equipment suppliers and home health agencies, applying for the first time for a provider number under the Medicare program and before granting billing privileges under such title, the Secretary shall screen the provider or supplier for a criminal background or other financial or operational irregularities through fingerprinting, licensure checks, site-visits, other database checks. (2)

Application fees

The Secretary shall impose an application charge on such a provider or supplier in order to cover the Secretary’s costs in performing the screening required under paragraph (1) and that is revenue neutral to the Federal government. (3)

Provisional approval

During an initial, provisional period (specified by the Secretary) In which such a provider or supplier has been issued such a number, the Secretary shall provide enhanced oversight of the activities of such provider or supplier under the Medicare program, such as through prepayment review and payment limitations. (4)

Penalties for false statements

In the case of a provider or supplier that makes a false statement in an application for such a number, the Secretary may exclude the provider or supplier from participation under the Medicare program, or may impose a civil money penalty (in the amount described in section 1128A(a)(4) of the Social Security Act), in the same manner as the Secretary may impose such an exclusion or penalty under sections 1128 and 1128A, respectively, of such Act in the case of knowing presentation of a false claim described in section 1128A(a)(1)(A) of such Act. (5)

Disclosure requirements

With respect to approval of such an application, the Secretary— (A)shall require applicants to disclose previous affiliation with enrolled entities that have uncollected debt related to the Medicare or Medicaid programs; (B)may deny approval if the Secretary determines that these affiliations pose undue risk to the Medicare or Medicaid program, subject to an appeals process for the applicant as determined by the Secretary; and (C)may implement enhanced safeguards (such as surety bonds). (b)

Moratoria

The Secretary may impose moratoria on approval of provider and supplier numbers under the Medicare program for new providers of services and suppliers as determined necessary to prevent or combat fraud a period of delay for any one applicant cannot exceed 30 days unless cause is shown by the Secretary. (c)

Funding

(1)

In general

There are authorized to be appropriated to carry out this section such sums as may be necessary. (2)

Condition

The provisions of paragraphs (1) and (2) of subsection (a) shall not apply unless and until funds are appropriated to carry out such provisions.

605.

Tracking banned providers across State lines

(a)

Greater coordination

The Secretary of Health and Human Services shall provide for increased coordination between the Administrator of the Centers for Medicare & Medicaid Services (in this section referred to as CMS) and its regional offices to ensure that providers of services and suppliers that have operated in one State and are excluded from participation in the Medicare program are unable to begin operation and participation in the Medicare program in another State. (b)

Improved information systems

(1)

In general

The Secretary shall improve information systems to allow greater integration between databases under the Medicare program so that— (A)Medicare administrative contractors, fiscal intermediaries, and carriers have immediate access to information identifying providers and suppliers excluded from participation in the Medicare and Medicaid program and other Federal health care programs; and (B)such information can be shared across Federal health care programs and agencies, including between the Departments of Health and Human Services, the Social Security Administration, the Department of Veterans Affairs, the Department of Defense, the Department of Justice, and the Office of Personnel Management. (c)

Medicare/Medicaid One PI database

The Secretary shall implement a database that includes claims and payment data for all components of the Medicare program and the Medicaid program. (d)

Authorizing expanded data matching

Notwithstanding any provision of the Computer Matching and Privacy Protection Act of 1988 to the contrary— (1)the Secretary and the Inspector General in the Department of Health and Human Services may perform data matching of data from the Medicare program with data from the Medicaid program; and (2)the Commissioner of Social Security and the Secretary may perform data matching of data of the Social Security Administration with data from the Medicare and Medicaid programs. (e)

Consolidation of databases

The Secretary shall consolidate and expand into a centralized database for individuals and entities that have been excluded from Federal health care programs the Healthcare Integrity and Protection Data Bank, the National Practitioner Data Bank, the List of Excluded Individuals/Entities, and a national patient abuse/neglect registry. (f)

Comprehensive provider database

(1)

Establishment

The Secretary shall establish a comprehensive database that includes information on providers of services, suppliers, and related entities participating in the Medicare program, the Medicaid program, or both. Such database shall include, information on ownership and business relationships, history of adverse actions, results of site visits or other monitoring by any program. (2)

Use

Prior to issuing a provider or supplier number for an entity under the Medicare program, the Secretary shall obtain information on the entity from such database to assure the entity qualifies for the issuance of such a number. (g)

Comprehensive sanctions database

The Secretary shall establish a comprehensive sanctions database on sanctions imposed on providers of services, suppliers, and related entities. Such database shall be overseen by the Inspector General of the Department of Health and Human Services and shall be linked to related databases maintained by State licensure boards and by Federal or State law enforcement agencies. (h)

Access to claims and payment databases

The Secretary shall ensure that the Inspector General of the Department of Health and Human Services and Federal law enforcement agencies have direct access to all claims and payment databases of the Secretary under the Medicare or Medicaid programs. (i)

Civil money penalties for submission of erroneous information

In the case of a provider of services, supplier, or other entity that submits erroneous information that serves as a basis for payment of any entity under the Medicare or Medicaid program, the Secretary may impose a civil money penalty of not to exceed $50,000 for each such erroneous submission. A civil money penalty under this subsection shall be imposed and collected in the same manner as a civil money penalty under subsection (a) of section 1128A of the Social Security Act is imposed and collected under that section.

G

Pathway for Biosimilar Biological Products

701.

Licensure pathway for biosimilar biological products

(a)

Licensure of Biological Products as Biosimilar or Interchangeable

Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended— (1)in subsection (a)(1)(A), by inserting under this subsection or subsection (k) after biologics license; and (2)by adding at the end the following: (k)

Licensure of biological products as biosimilar or interchangeable

(1)

In general

Any person may submit an application for licensure of a biological product under this subsection. (2)

Content

(A)

In general

(i)

Required information

An application submitted under this subsection shall include information demonstrating that— (I)the biological product is biosimilar to a reference product based upon data derived from— (aa)analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; (bb)animal studies (including the assessment of toxicity); and (cc)a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product; (II)the biological product and reference product utilize the same mechanism or mechanisms of action for the condition or conditions of use prescribed, recommended, or suggested in the proposed labeling, but only to the extent the mechanism or mechanisms of action are known for the reference product; (III)the condition or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; (IV)the route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product; and (V)the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent. (ii)

Determination by Secretary

The Secretary may determine, in the Secretary's discretion, that an element described in clause (i)(I) is unnecessary in an application submitted under this subsection. (iii)

Additional information

An application submitted under this subsection— (I)shall include publicly available information regarding the Secretary’s previous determination that the reference product is safe, pure, and potent; and (II)may include any additional information in support of the application, including publicly available information with respect to the reference product or another biological product. (B)

Interchangeability

An application (or a supplement to an application) submitted under this subsection may include information demonstrating that the biological product meets the standards described in paragraph (4). (3)

Evaluation by Secretary

Upon review of an application (or a supplement to an application) submitted under this subsection, the Secretary shall license the biological product under this subsection if— (A)the Secretary determines that the information submitted in the application (or the supplement) is sufficient to show that the biological product— (i)is biosimilar to the reference product; or (ii)meets the standards described in paragraph (4), and therefore is interchangeable with the reference product; and (B)the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c). (4)

Safety standards for determining interchangeability

Upon review of an application submitted under this subsection or any supplement to such application, the Secretary shall determine the biological product to be interchangeable with the reference product if the Secretary determines that the information submitted in the application (or a supplement to such application) is sufficient to show that— (A)the biological product— (i)is biosimilar to the reference product; and (ii)can be expected to produce the same clinical result as the reference product in any given patient; and (B)for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch. (5)

General rules

(A)

One reference product per application

A biological product, in an application submitted under this subsection, may not be evaluated against more than 1 reference product. (B)

Review

An application submitted under this subsection shall be reviewed by the division within the Food and Drug Administration that is responsible for the review and approval of the application under which the reference product is licensed. (C)

Risk evaluation and mitigation strategies

The authority of the Secretary with respect to risk evaluation and mitigation strategies under the Federal Food, Drug, and Cosmetic Act shall apply to biological products licensed under this subsection in the same manner as such authority applies to biological products licensed under subsection (a). (D)

Restrictions on biological products containing dangerous ingredients

If information in an application submitted under this subsection, in a supplement to such an application, or otherwise available to the Secretary shows that a biological product— (i)is, bears, or contains a select agent or toxin listed in section 73.3 or 73.4 of title 42, section 121.3 or 121.4 of title 9, or section 331.3 of title 7, Code of Federal Regulations (or any successor regulations); or (ii)is, bears, or contains a controlled substance in schedule I or II of section 202 of the Controlled Substances Act, as listed in part 1308 of title 21, Code of Federal Regulations (or any successor regulations); the Secretary shall not license the biological product under this subsection unless the Secretary determines, after consultation with appropriate national security and drug enforcement agencies, that there would be no increased risk to the security or health of the public from licensing such biological product under this subsection.(6)

Exclusivity for first interchangeable biological product

Upon review of an application submitted under this subsection relying on the same reference product for which a prior biological product has received a determination of interchangeability for any condition of use, the Secretary shall not make a determination under paragraph (4) that the second or subsequent biological product is interchangeable for any condition of use until the earlier of— (A)1 year after the first commercial marketing of the first interchangeable biosimilar biological product to be approved as interchangeable for that reference product; (B)18 months after— (i)a final court decision on all patents in suit in an action instituted under subsection (l)(5) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; or (ii)the dismissal with or without prejudice of an action instituted under subsection (l)(5) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; or (C)(i)42 months after approval of the first interchangeable biosimilar biological product if the applicant that submitted such application has been sued under subsection (l)(5) and such litigation is still ongoing within such 42-month period; or (ii)18 months after approval of the first interchangeable biosimilar biological product if the applicant that submitted such application has not been sued under subsection (l)(5). For purposes of this paragraph, the term final court decision means a final decision of a court from which no appeal (other than a petition to the United States Supreme Court for a writ of certiorari) has been or can be taken.(7)

Exclusivity for reference product

(A)

Effective date of biosimilar application approval

Approval of an application under this subsection may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed under subsection (a). (B)

Filing period

An application under this subsection may not be submitted to the Secretary until the date that is 4 years after the date on which the reference product was first licensed under subsection (a). (C)

First licensure

Subparagraphs (A) and (B) shall not apply to a license for or approval of— (i)a supplement for the biological product that is the reference product; or (ii)a subsequent application filed by the same sponsor or manufacturer of the biological product that is the reference product (or a licensor, predecessor in interest, or other related entity) for— (I)a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or (II)a modification to the structure of the biological product that does not result in a change in safety, purity, or potency. (8)

Pediatric studies

(A)

Exclusivity

If, before or after licensure of the reference product under subsection (a) of this section, the Secretary determines that information relating to the use of such product in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), the applicant or holder of the approved application agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with section 505A(d)(3) of the Federal Food, Drug, and Cosmetic Act the period referred to in paragraph (7)(A) of this subsection is deemed to be 12 years and 6 months rather than 12 years. (B)

Exception

The Secretary shall not extend the period referred to in subparagraph (A) of this paragraph if the determination under section 505A(d)(3) of the Federal Food, Drug, and Cosmetic Act is made later than 9 months prior to the expiration of such period. (C)

Application of certain provisions

The provisions of subsections (a), (d), (e), (f), (h), (j), (k), and (l) of section 505A of the Federal Food, Drug, and Cosmetic Act shall apply with respect to the extension of a period under subparagraph (A) of this paragraph to the same extent and in the same manner as such provisions apply with respect to the extension of a period under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act. (9)

Guidance documents

(A)

In general

The Secretary may, after opportunity for public comment, issue guidance in accordance, except as provided in subparagraph (B)(i), with section 701(h) of the Federal Food, Drug, and Cosmetic Act with respect to the licensure of a biological product under this subsection. Any such guidance may be general or specific. (B)

Public comment

(i)

In general

The Secretary shall provide the public an opportunity to comment on any proposed guidance issued under subparagraph (A) before issuing final guidance. (ii)

Input regarding most valuable guidance

The Secretary shall establish a process through which the public may provide the Secretary with input regarding priorities for issuing guidance. (C)

No requirement for application consideration

The issuance (or non-issuance) of guidance under subparagraph (A) shall not preclude the review of, or action on, an application submitted under this subsection. (D)

Requirement for product class-specific guidance

If the Secretary issues product class-specific guidance under subparagraph (A), such guidance shall include a description of— (i)the criteria that the Secretary will use to determine whether a biological product is highly similar to a reference product in such product class; and (ii)the criteria, if available, that the Secretary will use to determine whether a biological product meets the standards described in paragraph (4). (E)

Certain product classes

(i)

Guidance

The Secretary may indicate in a guidance document that the science and experience, as of the date of such guidance, with respect to a product or product class (not including any recombinant protein) does not allow approval of an application for a license as provided under this subsection for such product or product class. (ii)

Modification or reversal

The Secretary may issue a subsequent guidance document under subparagraph (A) to modify or reverse a guidance document under clause (i). (iii)

No effect on ability to deny license

Clause (i) shall not be construed to require the Secretary to approve a product with respect to which the Secretary has not indicated in a guidance document that the science and experience, as described in clause (i), does not allow approval of such an application. (10)

Naming

The Secretary shall ensure that the labeling and packaging of each biological product licensed under this subsection bears a name that uniquely identifies the biological product and distinguishes it from the reference product and any other biological products licensed under this subsection following evaluation against such reference product. (l)

Patent notices; relationship to final approval

(1)

Definitions

For the purposes of this subsection, the term— (A)biosimilar product means the biological product that is the subject of the application under subsection (k); (B)relevant patent means a patent that— (i)expires after the date specified in subsection (k)(7)(A) that applies to the reference product; and (ii)could reasonably be asserted against the applicant due to the unauthorized making, use, sale, or offer for sale within the United States, or the importation into the United States of the biosimilar product, or materials used in the manufacture of the biosimilar product, or due to a use of the biosimilar product in a method of treatment that is indicated in the application; (C)reference product sponsor means the holder of an approved application or license for the reference product; and (D)interested third party means a person other than the reference product sponsor that owns a relevant patent, or has the right to commence or participate in an action for infringement of a relevant patent. (2)

Handling of confidential information

Any entity receiving confidential information pursuant to this subsection shall designate one or more individuals to receive such information. Each individual so designated shall execute an agreement in accordance with regulations promulgated by the Secretary. The regulations shall require each such individual to take reasonable steps to maintain the confidentiality of information received pursuant to this subsection and use the information solely for purposes authorized by this subsection. The obligations imposed on an individual who has received confidential information pursuant to this subsection shall continue until the individual returns or destroys the confidential information, a court imposes a protective order that governs the use or handling of the confidential information, or the party providing the confidential information agrees to other terms or conditions regarding the handling or use of the confidential information. (3)

Public notice by secretary

Within 30 days of acceptance by the Secretary of an application filed under subsection (k), the Secretary shall publish a notice identifying— (A)the reference product identified in the application; and (B)the name and address of an agent designated by the applicant to receive notices pursuant to paragraph (4)(B). (4)

Exchanges concerning patents

(A)

Exchanges with reference product sponsor

(i)Within 30 days of the date of acceptance of the application by the Secretary, the applicant shall provide the reference product sponsor with a copy of the application and information concerning the biosimilar product and its production. This information shall include a detailed description of the biosimilar product, its method of manufacture, and the materials used in the manufacture of the product. (ii)Within 60 days of the date of receipt of the information required to be provided under clause (i), the reference product sponsor shall provide to the applicant a list of relevant patents owned by the reference product sponsor, or in respect of which the reference product sponsor has the right to commence an action of infringement or otherwise has an interest in the patent as such patent concerns the biosimilar product. (iii)If the reference product sponsor is issued or acquires an interest in a relevant patent after the date on which the reference product sponsor provides the list required by clause (ii) to the applicant, the reference product sponsor shall identify that patent to the applicant within 30 days of the date of issue of the patent, or the date of acquisition of the interest in the patent, as applicable. (B)

Exchanges with interested third parties

(i)At any time after the date on which the Secretary publishes a notice for an application under paragraph (3), any interested third party may provide notice to the designated agent of the applicant that the interested third party owns or has rights under 1 or more patents that may be relevant patents. The notice shall identify at least 1 patent and shall designate an individual who has executed an agreement in accordance with paragraph (2) to receive confidential information from the applicant. (ii)Within 30 days of the date of receiving notice pursuant to clause (i), the applicant shall send to the individual designated by the interested third party the information specified in subparagraph (A)(i), unless the applicant and interested third party otherwise agree. (iii)Within 90 days of the date of receiving information pursuant to clause (ii), the interested third party shall provide to the applicant a list of relevant patents which the interested third party owns, or in respect of which the interested third party has the right to commence or participate in an action for infringement. (iv)If the interested third party is issued or acquires an interest in a relevant patent after the date on which the interested third party provides the list required by clause (iii), the interested third party shall identify that patent within 30 days of the date of issue of the patent, or the date of acquisition of the interest in the patent, as applicable. (C)

Identification of basis for infringement

For any patent identified under clause (ii) or (iii) of subparagraph (A) or under clause (iii) or (iv) of subparagraph (B), the reference product sponsor or the interested third party, as applicable— (i)shall explain in writing why the sponsor or the interested third party believes the relevant patent would be infringed by the making, use, sale, or offer for sale within the United States, or importation into the United States, of the biosimilar product or by a use of the biosimilar product in treatment that is indicated in the application; (ii)may specify whether the relevant patent is available for licensing; and (iii)shall specify the number and date of expiration of the relevant patent. (D)

Certification by applicant concerning identified relevant patents

Not later than 45 days after the date on which a patent is identified under clause (ii) or (iii) of subparagraph (A) or under clause (iii) or (iv) of subparagraph (B), the applicant shall send a written statement regarding each identified patent to the party that identified the patent. Such statement shall either— (i)state that the applicant will not commence marketing of the biosimilar product and has requested the Secretary to not grant final approval of the application before the date of expiration of the noticed patent; or (ii)provide a detailed written explanation setting forth the reasons why the applicant believes— (I)the making, use, sale, or offer for sale within the United States, or the importation into the United States, of the biosimilar product, or the use of the biosimilar product in a treatment indicated in the application, would not infringe the patent; or (II)the patent is invalid or unenforceable. (5)

Action for infringement involving reference product sponsor

If an action for infringement concerning a relevant patent identified by the reference product sponsor under clause (ii) or (iii) of paragraph (4)(A), or by an interested third party under clause (iii) or (iv) of paragraph (4)(B), is brought within 60 days of the date of receipt of a statement under paragraph (4)(D)(ii), and the court in which such action has been commenced determines the patent is infringed prior to the date applicable under subsection (k)(7)(A) or (k)(8), the Secretary shall make approval of the application effective on the day after the date of expiration of the patent that has been found to be infringed. If more than one such patent is found to be infringed by the court, the approval of the application shall be made effective on the day after the date that the last such patent expires. (6)

Notification of agreements

(A)

Requirements

(i)

Agreement between biosimilar product applicant and reference product sponsor

If a biosimilar product applicant under subsection (k) and the reference product sponsor enter into an agreement described in subparagraph (B), the applicant and sponsor shall each file the agreement in accordance with subparagraph (C). (ii)

Agreement between biosimilar product applicants

If 2 or more biosimilar product applicants submit an application under subsection (k) for biosimilar products with the same reference product and enter into an agreement described in subparagraph (B), the applicants shall each file the agreement in accordance with subparagraph (C). (B)

Subject matter of agreement

An agreement described in this subparagraph— (i)is an agreement between the biosimilar product applicant under subsection (k) and the reference product sponsor or between 2 or more biosimilar product applicants under subsection (k) regarding the manufacture, marketing, or sale of— (I)the biosimilar product (or biosimilar products) for which an application was submitted; or (II)the reference product; (ii)includes any agreement between the biosimilar product applicant under subsection (k) and the reference product sponsor or between 2 or more biosimilar product applicants under subsection (k) that is contingent upon, provides a contingent condition for, or otherwise relates to an agreement described in clause (i); and (iii)excludes any agreement that solely concerns— (I)purchase orders for raw material supplies; (II)equipment and facility contracts; (III)employment or consulting contracts; or (IV)packaging and labeling contracts. (C)

Filing

(i)

In general

The text of an agreement required to be filed by subparagraph (A) shall be filed with the Assistant Attorney General and the Federal Trade Commission not later than— (I)10 business days after the date on which the agreement is executed; and (II)prior to the date of the first commercial marketing of, for agreements described in subparagraph (A)(i), the biosimilar product that is the subject of the application or, for agreements described in subparagraph (A)(ii), any biosimilar product that is the subject of an application described in such subparagraph. (ii)

If agreement not reduced to text

If an agreement required to be filed by subparagraph (A) has not been reduced to text, the persons required to file the agreement shall each file written descriptions of the agreement that are sufficient to disclose all the terms and conditions of the agreement. (iii)

Certification

The chief executive officer or the company official responsible for negotiating any agreement required to be filed by subparagraph (A) shall include in any filing under this paragraph a certification as follows: I declare under penalty of perjury that the following is true and correct: The materials filed with the Federal Trade Commission and the Department of Justice under section 351(l)(6) of the Public Health Service Act, with respect to the agreement referenced in this certification: (1) represent the complete, final, and exclusive agreement between the parties; (2) include any ancillary agreements that are contingent upon, provide a contingent condition for, or are otherwise related to, the referenced agreement; and (3) include written descriptions of any oral agreements, representations, commitments, or promises between the parties that are responsive to such section and have not been reduced to writing.. (D)

Disclosure exemption

Any information or documentary material filed with the Assistant Attorney General or the Federal Trade Commission pursuant to this paragraph shall be exempt from disclosure under section 552 of title 5, United States Code, and no such information or documentary material may be made public, except as may be relevant to any administrative or judicial action or proceeding. Nothing in this subparagraph prevents disclosure of information or documentary material to either body of the Congress or to any duly authorized committee or subcommittee of the Congress. (E)

Enforcement

(i)

Civil penalty

Any person that violates a provision of this paragraph shall be liable for a civil penalty of not more than $11,000 for each day on which the violation occurs. Such penalty may be recovered in a civil action— (I)brought by the United States; or (II)brought by the Federal Trade Commission in accordance with the procedures established in section 16(a)(1) of the Federal Trade Commission Act. (ii)

Compliance and equitable relief

If any person violates any provision of this paragraph, the United States district court may order compliance, and may grant such other equitable relief as the court in its discretion determines necessary or appropriate, upon application of the Assistant Attorney General or the Federal Trade Commission. (F)

Rulemaking

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

Savings clause

Any action taken by the Assistant Attorney General or the Federal Trade Commission, or any failure of the Assistant Attorney General or the Commission to take action, under this paragraph shall not at any time bar any proceeding or any action with respect to any agreement between a biosimilar product applicant under subsection (k) and the reference product sponsor, or any agreement between biosimilar product applicants under subsection (k), under any other provision of law, nor shall any filing under this paragraph constitute or create a presumption of any violation of any competition laws. . (b)

Definitions

Section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)) is amended— (1)by striking In this section, the term biological product means and inserting the following: In this section:(1)The term biological product means ; (2)in paragraph (1), as so designated, by inserting protein (except any chemically synthesized polypeptide), after allergenic product,; and (3)by adding at the end the following: (2)The term biosimilar or biosimilarity, in reference to a biological product that is the subject of an application under subsection (k), means— (A)that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and (B)there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. (3)The term interchangeable or interchangeability, in reference to a biological product that is shown to meet the standards described in subsection (k)(4), means that the biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. (4)The term reference product means the single biological product licensed under subsection (a) against which a biological product is evaluated in an application submitted under subsection (k). . (c)

Products Previously Approved Under Section 505

(1)

Requirement to follow section 351

Except as provided in paragraph (2), an application for a biological product shall be submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) (as amended by this Act). (2)

Exception

An application for a biological product may be submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) if— (A)such biological product is in a product class for which a biological product in such product class is the subject of an application approved under such section 505 not later than the date of enactment of this Act; and (B)such application— (i)has been submitted to the Secretary of Health and Human Services (referred to in this Act as the Secretary) before the date of enactment of this Act; or (ii)is submitted to the Secretary not later than the date that is 10 years after the date of enactment of this Act. (3)

Limitation

Notwithstanding paragraph (2), an application for a biological product may not be submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) if there is another biological product approved under subsection (a) of section 351 of the Public Health Service Act that could be a reference product with respect to such application (within the meaning of such section 351) if such application were submitted under subsection (k) of such section 351. (4)

Deemed approved under section 351

An approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) shall be deemed to be a license for the biological product under such section 351 on the date that is 10 years after the date of enactment of this Act. (5)

Definitions

For purposes of this subsection, the term biological product has the meaning given such term under section 351 of the Public Health Service Act (42 U.S.C. 262) (as amended by this Act).

702.

Fees relating to biosimilar biological products

Subparagraph (B) of section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended by inserting , including licensure of a biological product under section 351(k) of such Act before the period at the end.

703.

Amendments to certain patent provisions

(a)Section 271(e)(2) of title 35, United States Code is amended— (1)in subparagraph (A), by striking or after patent,; (2)in subparagraph (B), by adding or after the comma at the end; (3)by inserting the following after subparagraph (B): (C)a statement under section 351(l)(4)(D)(ii) of the Public Health Service Act, ; and (4)in the matter following subparagraph (C) (as added by paragraph (3)), by inserting before the period the following: , or if the statement described in subparagraph (C) is provided in connection with an application to obtain a license to engage in the commercial manufacture, use, or sale of a biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent. (b)Section 271(e)(4) of title 35, United States Code, is amended by striking in paragraph (2) in both places it appears and inserting in paragraph (2)(A) or (2)(B).