I 

111TH CONGRESS 

1ST SESSION H. R. 3483 

To reform the medical liability system, improve access to health care for 

rural and indigent patients, enhance access to affordable prescription 

drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 31, 2009 

Mr. HELLER introduced the following bill; which was referred to the Committee on Ways and Means, and in addition to the Committee on Energy 

and Commerce, 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 reform the medical liability system, improve access to 

health care for rural and indigent patients, enhance access to affordable prescription drugs, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Steps Toward Access and Reform Act of 2009’’ or the 

6 ‘‘STAR Act of 2009’’. 


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1 (b) TABLE OF CONTENTS.—The table of contents of 

2 this Act is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—MEDICAL LIABILITY REFORM 

Sec. 101. Encouraging speedy resolution of claims. 

Sec. 102. Compensating patient injury. 

Sec. 103. Maximizing patient recovery. 

Sec. 104. Additional collateral source benefits. 

Sec. 105. Punitive damages. 

Sec. 106. Authorization of payment of future damages to claimants in health 

care lawsuits. 

Sec. 107. Effect on other laws. 

Sec. 108. State flexibility and protection of States’ rights. 

Sec. 109. Applicability; effective date. 

Sec. 110. Sense of Congress. 

Sec. 111. Definitions. 

TITLE II—IMPROVING ACCESS FOR RURAL AND INDIGENT 

PATIENTS 

Sec. 201. Improving access for rural and indigent patients. 

TITLE III—PROMOTING AFFORDABLE PRESCRIPTION DRUGS BY 

DEFINING OBJECTIVES IN NEGOTIATION OF TRADE AGREEMENTS 

Sec. 301. Promoting affordable prescription drugs by defining objectives in negotiation of trade agreements. 

TITLE IV—ENCOURAGING PREVENTATIVE CARE 

Sec. 401. Encouraging preventative care. 

3 TITLE I—MEDICAL LIABILITY 

4 REFORM 

5 SEC. 101. ENCOURAGING SPEEDY RESOLUTION OF CLAIMS. 

6 The time for the commencement of a health care law7 suit shall be 3 years after the date of manifestation of 

8 injury or 1 year after the claimant discovers, or through 

9 the use of reasonable diligence should have discovered, the 

10 injury, whichever occurs first. In no event shall the time 

11 for commencement of a health care lawsuit exceed 3 years 


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1 after the date of manifestation of injury unless tolled for 

2 any of the following— 

3 (1) upon proof of fraud; 

4 (2) intentional concealment; or 

5 (3) the presence of a foreign body, which has no 

6 therapeutic or diagnostic purpose or effect, in the 

7 body of the injured person. 

8 Actions by a minor shall be commenced within 3 years 

9 from the date of the alleged manifestation of injury except 

10 that actions by a minor under the full age of 6 years shall 

11 be commenced within 3 years of manifestation of injury 

12 or prior to the minor’s 8th birthday, whichever provides 

13 a longer period. Such time limitation shall be tolled for 

14 minors for any period during which a parent or guardian 

15 and a health care provider or health care organization 

16 have committed fraud or collusion in the failure to bring 

17 an action on behalf of the injured minor. 

18 SEC. 102. COMPENSATING PATIENT INJURY. 

19 (a) UNLIMITED AMOUNT OF DAMAGES FOR ACTUAL

20 ECONOMIC LOSSES IN HEALTH CARE LAWSUITS.—In any 

21 health care lawsuit, nothing in this title shall limit a claim22 ant’s recovery of the full amount of the available economic 

23 damages, notwithstanding the limitation in subsection (b). 

24 (b) ADDITIONAL NONECONOMIC DAMAGES.—In any 

25 health care lawsuit, the amount of noneconomic damages, 


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1 if available, shall not exceed $250,000, regardless of the 

2 number of parties against whom the action is brought or 

3 the number of separate claims or actions brought with re4 spect to the same injury. 

5 (c) NO DISCOUNT OF AWARD FOR NONECONOMIC

6 DAMAGES.—For purposes of applying the limitation in 

7 subsection (b), future noneconomic damages shall not be 

8 discounted to present value. The jury shall not be in9 formed about the maximum award for noneconomic dam10 ages. An award for noneconomic damages in excess of 

11 $250,000 shall be reduced either before the entry of judg12 ment, or by amendment of the judgment after entry of 

13 judgment, and such reduction shall be made before ac14 counting for any other reduction in damages required by 

15 law. If separate awards are rendered for past and future 

16 noneconomic damages and the combined awards exceed 

17 $250,000, the future noneconomic damages shall be re18 duced first. 

19 (d) FAIR SHARE RULE.—In any health care lawsuit, 

20 each party shall be liable for that party’s several share 

21 of any damages only and not for the share of any other 

22 person. Each party shall be liable only for the amount of 

23 damages allocated to such party in direct proportion to 

24 such party’s percentage of responsibility. Whenever a 

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1 rate judgment shall be rendered against each such party 

2 for the amount allocated to such party. For purposes of 

3 this section, the trier of fact shall determine the propor4 tion of responsibility of each party for the claimant’s 

5 harm. 

6 SEC. 103. MAXIMIZING PATIENT RECOVERY. 

7 (a) COURT SUPERVISION OF SHARE OF DAMAGES

8 ACTUALLY PAID TO CLAIMANTS.—In any health care law9 suit, the court shall supervise the arrangements for pay10 ment of damages to protect against conflicts of interest 

11 that may have the effect of reducing the amount of dam12 ages awarded that are actually paid to claimants. In par13 ticular, in any health care lawsuit in which the attorney 

14 for a party claims a financial stake in the outcome by vir15 tue of a contingent fee, the court shall have the power 

16 to restrict the payment of a claimant’s damage recovery 

17 to such attorney, and to redirect such damages to the 

18 claimant based upon the interests of justice and principles 

19 of equity. In no event shall the total of all contingent fees 

20 for representing all claimants in a health care lawsuit ex21 ceed the following limits: 

22 (1) 40 percent of the first $50,000 recovered by 

23 the claimants. 

(2) 331 24 ⁄3 percent of the next $50,000 recovered 

25 by the claimants. 


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1 (3) 25 percent of the next $500,000 recovered 

2 by the claimants. 

3 (4) 15 percent of any amount by which the re4 covery by the claimants is in excess of $600,000. 

5 (b) APPLICABILITY.—The limitations in this section 

6 shall apply whether the recovery is by judgment, settle7 ment, mediation, arbitration, or any other form of alter8 native dispute resolution. In a health care lawsuit involv9 ing a minor or incompetent person, a court retains the 

10 authority to authorize or approve a fee that is less than 

11 the maximum permitted under this section. The require12 ment for court supervision in the first two sentences of 

13 subsection (a) applies only in civil actions. 

14 SEC. 104. ADDITIONAL COLLATERAL SOURCE BENEFITS. 

15 In any health care lawsuit involving injury or wrong16 ful death, any party may introduce evidence of collateral 

17 source benefits. If a party elects to introduce such evi18 dence, any opposing party may introduce evidence of any 

19 amount paid or contributed or reasonably likely to be paid 

20 or contributed in the future by or on behalf of the oppos21 ing party to secure the right to such collateral source bene22 fits. No provider of collateral source benefits shall recover 

23 any amount against the claimant or receive any lien or 

24 credit against the claimant’s recovery or be equitably or 

25 legally subrogated to the right of the claimant in a health 


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1 care lawsuit involving injury or wrongful death. This sec2 tion shall apply to any health care lawsuit that is settled 

3 as well as a health care lawsuit that is resolved by a fact 

4 finder. This section shall not apply to section 1862(b) (42 

5 U.S.C. 1395y(b)) or section 1902(a)(25) (42 U.S.C. 

6 1396a(a)(25)) of the Social Security Act. 

7 SEC. 105. PUNITIVE DAMAGES. 

8 (a) IN GENERAL.—Punitive damages may, if other9 wise permitted by applicable State or Federal law, be 

10 awarded against any person in a health care lawsuit only 

11 if it is proven by clear and convincing evidence that such 

12 person acted with malicious intent to injure the claimant, 

13 or that such person deliberately failed to avoid unneces14 sary injury that such person knew the claimant was sub15 stantially certain to suffer. In any health care lawsuit 

16 where no judgment for compensatory damages is rendered 

17 against such person, no punitive damages may be awarded 

18 with respect to the claim in such lawsuit. No demand for 

19 punitive damages shall be included in a health care lawsuit 

20 as initially filed. A court may allow a claimant to file an 

21 amended pleading for punitive damages only upon a mo22 tion by the claimant and after a finding by the court, upon 

23 review of supporting and opposing affidavits or after a 

24 hearing, after weighing the evidence, that the claimant has 

25 established by a substantial probability that the claimant 


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1 will prevail on the claim for punitive damages. At the re2 quest of any party in a health care lawsuit, the trier of 

3 fact shall consider in a separate proceeding— 

4 (1) whether punitive damages are to be award5 ed and the amount of such award; and 

6 (2) the amount of punitive damages following a 

7 determination of punitive liability. 

8 If a separate proceeding is requested, evidence relevant 

9 only to the claim for punitive damages, as determined by 

10 applicable State law, shall be inadmissible in any pro11 ceeding to determine whether compensatory damages are 

12 to be awarded. 

13 (b) DETERMINING AMOUNT OF PUNITIVE DAM14 AGES.— 

15 (1) FACTORS CONSIDERED.—In determining 

16 the amount of punitive damages, if awarded, in a 

17 health care lawsuit, the trier of fact shall consider 

18 only the following— 

19 (A) the severity of the harm caused by the 

20 conduct of such party; 

21 (B) the duration of the conduct or any 

22 concealment of it by such party; 

23 (C) the profitability of the conduct to such 

24 party; 


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1 (D) the number of products sold or med2 ical procedures rendered for compensation, as 

3 the case may be, by such party, of the kind 

4 causing the harm complained of by the claim5 ant; 

6 (E) any criminal penalties imposed on such 

7 party, as a result of the conduct complained of 

8 by the claimant; and 

9 (F) the amount of any civil fines assessed 

10 against such party as a result of the conduct 

11 complained of by the claimant. 

12 (2) MAXIMUM AWARD.—The amount of punitive 

13 damages, if awarded, in a health care lawsuit may 

14 not exceed $250,000 or two times the amount of 

15 economic damages awarded, whichever is greater. 

16 The jury shall not be informed of this limitation. 

17 (c) NO PUNITIVE DAMAGES FOR PRODUCTS THAT

18 COMPLY WITH FDA STANDARDS.— 

19 (1) IN GENERAL.— 

20 (A) No punitive damages may be awarded 

21 against the manufacturer or distributor of a 

22 medical product, or a supplier of any compo23 nent or raw material of such medical product, 

24 based on a claim that such product caused the 

25 claimant’s harm where— 


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1 (i)(I) such medical product was sub2 ject to premarket approval, clearance, or li3 censure by the Food and Drug Administra4 tion with respect to the safety of the for5 mulation or performance of the aspect of 

6 such medical product which caused the 

7 claimant’s harm or the adequacy of the 

8 packaging or labeling of such medical 

9 product; and 

10 (II) such medical product was so ap11 proved, cleared, or licensed; or 

12 (ii) such medical product is generally 

13 recognized among qualified experts as safe 

14 and effective pursuant to conditions estab15 lished by the Food and Drug Administra16 tion and applicable Food and Drug Admin17 istration regulations, including without 

18 limitation those related to packaging and 

19 labeling, unless the Food and Drug Admin20 istration has determined that such medical 

21 product was not manufactured or distrib22 uted in substantial compliance with appli23 cable Food and Drug Administration stat24 utes and regulations. 


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1 (B) RULE OF CONSTRUCTION.—Subpara2 graph (A) may not be construed as establishing 

3 the obligation of the Food and Drug Adminis4 tration to demonstrate affirmatively that a 

5 manufacturer, distributor, or supplier referred 

6 to in such subparagraph meets any of the con7 ditions described in such subparagraph. 

8 (2) LIABILITY OF HEALTH CARE PROVIDERS.— 

9 A health care provider who prescribes, or who dis10 penses pursuant to a prescription, a medical product 

11 approved, licensed, or cleared by the Food and Drug 

12 Administration shall not be named as a party to a 

13 product liability lawsuit involving such product and 

14 shall not be liable to a claimant in a class action 

15 lawsuit against the manufacturer, distributor, or 

16 seller of such product. Nothing in this paragraph 

17 prevents a court from consolidating cases involving 

18 health care providers and cases involving products li19 ability claims against the manufacturer, distributor, 

20 or product seller of such medical product. 

21 (3) PACKAGING.—In a health care lawsuit for 

22 harm which is alleged to relate to the adequacy of 

23 the packaging or labeling of a drug which is required 

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1 ices (including labeling regulations related to such 

2 packaging), the manufacturer or product seller of 

3 the drug shall not be held liable for punitive dam4 ages unless such packaging or labeling is found by 

5 the trier of fact by clear and convincing evidence to 

6 be substantially out of compliance with such regula7 tions. 

8 (4) EXCEPTION.—Paragraph (1) shall not 

9 apply in any health care lawsuit in which— 

10 (A) a person, before or after premarket ap11 proval, clearance, or licensure of such medical 

12 product, knowingly misrepresented to or with13 held from the Food and Drug Administration 

14 information that is required to be submitted 

15 under the Federal Food, Drug, and Cosmetic 

16 Act (21 U.S.C. 301 et seq.) or section 351 of 

17 the Public Health Service Act (42 U.S.C. 262) 

18 that is material and is causally related to the 

19 harm which the claimant allegedly suffered; or 

20 (B) a person made an illegal payment to 

21 an official of the Food and Drug Administra22 tion for the purpose of either securing or main23 taining approval, clearance, or licensure of such 

24 medical product. 


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1 SEC. 106. AUTHORIZATION OF PAYMENT OF FUTURE DAM2 AGES TO CLAIMANTS IN HEALTH CARE LAW3 SUITS. 

4 (a) IN GENERAL.—In any health care lawsuit, if an 

5 award of future damages, without reduction to present 

6 value, equaling or exceeding $50,000 is made against a 

7 party with sufficient insurance or other assets to fund a 

8 periodic payment of such a judgment, the court shall, at 

9 the request of any party, enter a judgment ordering that 

10 the future damages be paid by periodic payments. In any 

11 health care lawsuit, the court may be guided by the Uni12 form Periodic Payment of Judgments Act promulgated by 

13 the National Conference of Commissioners on Uniform 

14 State Laws. 

15 (b) APPLICABILITY.—This section applies to all ac16 tions which have not been first set for trial or retrial be17 fore the effective date of this Act. 

18 SEC. 107. EFFECT ON OTHER LAWS. 

19 (a) VACCINE INJURY.— 

20 (1) To the extent that title XXI of the Public 

21 Health Service Act establishes a Federal rule of law 

22 applicable to a civil action brought for a vaccine-re23 lated injury or death— 

24 (A) this title does not affect the application 

25 of the rule of law to such an action; and 


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1 (B) any rule of law prescribed by this title 

2 in conflict with a rule of law of such title XXI 

3 shall not apply to such action. 

4 (2) If there is an aspect of a civil action 

5 brought for a vaccine-related injury or death to 

6 which a Federal rule of law under title XXI of the 

7 Public Health Service Act does not apply, then this 

8 title or otherwise applicable law (as determined 

9 under this title) will apply to such aspect of such ac10 tion. 

11 (b) OTHER FEDERAL LAW.—Except as provided in 

12 this section, nothing in this title shall be deemed to affect 

13 any defense available to a defendant in a health care law14 suit or action under any other provision of Federal law. 

15 SEC. 108. STATE FLEXIBILITY AND PROTECTION OF 

16 STATES’ RIGHTS. 

17 (a) HEALTH CARE LAWSUITS.—The provisions gov18 erning health care lawsuits set forth in this title preempt, 

19 subject to subsections (b) and (c), State law to the extent 

20 that State law prevents the application of any provisions 

21 of law established by or under this title. The provisions 

22 governing health care lawsuits set forth in this title super23 sede chapter 171 of title 28, United States Code, to the 

24 extent that such chapter— 


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1 (1) provides for a greater amount of damages 

2 or contingent fees, a longer period in which a health 

3 care lawsuit may be commenced, or a reduced appli4 cability or scope of periodic payment of future dam5 ages, than provided in this title; or 

6 (2) prohibits the introduction of evidence re7 garding collateral source benefits, or mandates or 

8 permits subrogation or a lien on collateral source 

9 benefits. 

10 (b) PROTECTION OF STATES’ RIGHTS AND OTHER

11 LAWS.—(1) Any issue that is not governed by any provi12 sion of law established by or under this title (including 

13 State standards of negligence) shall be governed by other14 wise applicable State or Federal law. 

15 (2) This title shall not preempt or supersede any 

16 State or Federal law that imposes greater procedural or 

17 substantive protections for health care providers and 

18 health care organizations from liability, loss, or damages 

19 than those provided by this title or create a cause of ac20 tion. 

21 (c) STATE FLEXIBILITY.—No provision of this title 

22 shall be construed to preempt— 

23 (1) any State law (whether effective before, on, 

24 or after the date of the enactment of this Act) that 

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1 satory or punitive damages (or the total amount of 

2 damages) that may be awarded in a health care law3 suit, regardless of whether such monetary amount is 

4 greater or lesser than is provided for under this title, 

5 notwithstanding section 104(a); or 

6 (2) any defense available to a party in a health 

7 care lawsuit under any other provision of State or 

8 Federal law. 

9 SEC. 109. APPLICABILITY; EFFECTIVE DATE. 

10 This title shall apply to any health care lawsuit 

11 brought in a Federal or State court, or subject to an alter12 native dispute resolution system, that is initiated on or 

13 after the date of the enactment of this Act, except that 

14 any health care lawsuit arising from an injury occurring 

15 prior to the date of the enactment of this Act shall be 

16 governed by the applicable statute of limitations provisions 

17 in effect at the time the injury occurred. 

18 SEC. 110. SENSE OF CONGRESS. 

19 It is the sense of Congress that a health insurer 

20 should be liable for damages for harm caused when it 

21 makes a decision as to what care is medically necessary 

22 and appropriate. 

23 SEC. 111. DEFINITIONS. 

24 In this title: 


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1 (1) ALTERNATIVE DISPUTE RESOLUTION SYS2 TEM; ADR.—The term ‘‘alternative dispute resolution 

3 system’’ or ‘‘ADR’’ means a system that provides 

4 for the resolution of health care lawsuits in a man5 ner other than through a civil action brought in a 

6 State or Federal court. 

7 (2) CLAIMANT.—The term ‘‘claimant’’ means 

8 any person who brings a title, including a person 

9 who asserts or claims a right to legal or equitable 

10 contribution, indemnity, or subrogation, arising out 

11 of a health care liability claim or action, and any 

12 person on whose behalf such a claim is asserted or 

13 such an action is brought, whether deceased, incom14 petent, or a minor. 

15 (3) COLLATERAL SOURCE BENEFITS.—The 

16 term ‘‘collateral source benefits’’ means any amount 

17 paid or reasonably likely to be paid in the future to 

18 or on behalf of the claimant, or any service, product, 

19 or other benefit provided or reasonably likely to be 

20 provided in the future to or on behalf of the claim21 ant, as a result of the injury or wrongful death, pur22 suant to— 

23 (A) any State or Federal health, sickness, 

24 income-disability, accident, or workers’ com25 pensation law; 


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1 (B) any health, sickness, income-disability, 

2 or accident insurance that provides health bene3 fits or income-disability coverage; 

4 (C) any contract or agreement of any 

5 group, organization, partnership, or corporation 

6 to provide, pay for, or reimburse the cost of 

7 medical, hospital, dental, or income-disability 

8 benefits; and 

9 (D) any other publicly or privately funded 

10 program. 

11 (4) COMPENSATORY DAMAGES.—The term 

12 ‘‘compensatory damages’’ means objectively 

13 verifiable monetary losses incurred as a result of the 

14 provision of, use of, or payment for (or failure to 

15 provide, use, or pay for) health care services or med16 ical products, such as past and future medical ex17 penses, loss of past and future earnings, cost of ob18 taining domestic services, loss of employment, and 

19 loss of business or employment opportunities, dam20 ages for physical and emotional pain, suffering, in21 convenience, physical impairment, mental anguish, 

22 disfigurement, loss of enjoyment of life, loss of soci23 ety and companionship, loss of consortium (other 

24 than loss of domestic service), hedonic damages, in25 jury to reputation, and all other nonpecuniary losses 


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1 of any kind or nature. The term ‘‘compensatory 

2 damages’’ includes economic damages and non3 economic damages, as such terms are defined in this 

4 section. 

5 (5) CONTINGENT FEE.—The term ‘‘contingent 

6 fee’’ includes all compensation to any person or per7 sons which is payable only if a recovery is effected 

8 on behalf of one or more claimants. 

9 (6) ECONOMIC DAMAGES.—The term ‘‘economic 

10 damages’’ means objectively verifiable monetary 

11 losses incurred as a result of the provision of, use 

12 of, or payment for (or failure to provide, use, or pay 

13 for) health care services or medical products, such as 

14 past and future medical expenses, loss of past and 

15 future earnings, cost of obtaining domestic services, 

16 loss of employment, and loss of business or employ17 ment opportunities. 

18 (7) HEALTH CARE LAWSUIT.—The term 

19 ‘‘health care lawsuit’’ means any health care liability 

20 claim concerning the provision of health care goods 

21 or services or any medical product affecting inter22 state commerce, or any health care liability action 

23 concerning the provision of health care goods or 

24 services or any medical product affecting interstate 

25 commerce, brought in a State or Federal court or 


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1 pursuant to an alternative dispute resolution system, 

2 against a health care provider, a health care organi3 zation, or the manufacturer, distributor, supplier, 

4 marketer, promoter, or seller of a medical product, 

5 regardless of the theory of liability on which the 

6 claim is based, or the number of claimants, plain7 tiffs, defendants, or other parties, or the number of 

8 claims or causes of action, in which the claimant al9 leges a health care liability claim. Such term does 

10 not include a claim or action which is based on 

11 criminal liability; which seeks civil fines or penalties 

12 paid to Federal, State, or local government; or which 

13 is grounded in antitrust. 

14 (8) HEALTH CARE LIABILITY ACTION.—The 

15 term ‘‘health care liability action’’ means a civil ac16 tion brought in a State or Federal court or pursuant 

17 to an alternative dispute resolution system, against 

18 a health care provider, a health care organization, or 

19 the manufacturer, distributor, supplier, marketer, 

20 promoter, or seller of a medical product, regardless 

21 of the theory of liability on which the claim is based, 

22 or the number of plaintiffs, defendants, or other par23 ties, or the number of causes of action, in which the 

24 claimant alleges a health care liability claim. 


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1 (9) HEALTH CARE LIABILITY CLAIM.—The 

2 term ‘‘health care liability claim’’ means a demand 

3 by any person, whether or not pursuant to ADR, 

4 against a health care provider, health care organiza5 tion, or the manufacturer, distributor, supplier, mar6 keter, promoter, or seller of a medical product, in7 cluding, but not limited to, third-party claims, cross8 claims, counter-claims, or contribution claims, which 

9 are based upon the provision of, use of, or payment 

10 for (or the failure to provide, use, or pay for) health 

11 care services or medical products, regardless of the 

12 theory of liability on which the claim is based, or the 

13 number of plaintiffs, defendants, or other parties, or 

14 the number of causes of action. 

15 (10) HEALTH CARE ORGANIZATION.—The term 

16 ‘‘health care organization’’ means any person or en17 tity which is obligated to provide or pay for health 

18 benefits under any health plan, including any person 

19 or entity acting under a contract or arrangement 

20 with a health care organization to provide or admin21 ister any health benefit. 

22 (11) HEALTH CARE PROVIDER.—The term 

23 ‘‘health care provider’’ means any person or entity 

24 required by State or Federal laws or regulations to 

25 be licensed, registered, or certified to provide health 


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1 care services, and being either so licensed, reg2 istered, or certified, or exempted from such require3 ment by other statute or regulation. 

4 (12) HEALTH CARE GOODS OR SERVICES.—The 

5 term ‘‘health care goods or services’’ means any 

6 goods or services provided by a health care organiza7 tion, provider, or by any individual working under 

8 the supervision of a health care provider, that relates 

9 to the diagnosis, prevention, or treatment of any 

10 human disease or impairment, or the assessment or 

11 care of the health of human beings. 

12 (13) MALICIOUS INTENT TO INJURE.—The 

13 term ‘‘malicious intent to injure’’ means inten14 tionally causing or attempting to cause physical in15 jury other than providing health care goods or serv16 ices. 

17 (14) MEDICAL PRODUCT.—The term ‘‘medical 

18 product’’ means a drug, device, or biological product 

19 intended for humans, and the terms ‘‘drug’’, ‘‘de20 vice’’, and ‘‘biological product’’ have the meanings 

21 given such terms in sections 201(g)(1) and 201(h) 

22 of the Federal Food, Drug and Cosmetic Act (21 

23 U.S.C. 321(g)(1) and (h)) and section 351(a) of the 

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1 spectively, including any component or raw material 

2 used therein, but excluding health care services. 

3 (15) NONECONOMIC DAMAGES.—The term 

4 ‘‘noneconomic damages’’ means damages for phys5 ical and emotional pain, suffering, inconvenience, 

6 physical impairment, mental anguish, disfigurement, 

7 loss of enjoyment of life, loss of society and compan8 ionship, loss of consortium (other than loss of do9 mestic service), hedonic damages, injury to reputa10 tion, and all other nonpecuniary losses of any kind 

11 or nature. 

12 (16) PUNITIVE DAMAGES.—The term ‘‘punitive 

13 damages’’ means damages awarded, for the purpose 

14 of punishment or deterrence, and not solely for com15 pensatory purposes, against a health care provider, 

16 health care organization, or a manufacturer, dis17 tributor, or supplier of a medical product. Punitive 

18 damages are neither economic nor noneconomic 

19 damages. 

20 (17) RECOVERY.—The term ‘‘recovery’’ means 

21 the net sum recovered after deducting any disburse22 ments or costs incurred in connection with prosecu23 tion or settlement of the claim, including all costs 

24 paid or advanced by any person. Costs of health care 

25 incurred by the plaintiff and the attorneys’ office 


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1 overhead costs or charges for legal services are not 

2 deductible disbursements or costs for such purpose. 

3 (18) STATE.—The term ‘‘State’’ means each of 

4 the several States, the District of Columbia, the 

5 Commonwealth of Puerto Rico, the Virgin Islands, 

6 Guam, American Samoa, the Northern Mariana Is7 lands, the Trust Territory of the Pacific Islands, and 

8 any other territory or possession of the United 

9 States, or any political subdivision thereof. 

10 TITLE II—IMPROVING ACCESS 

11 FOR RURAL AND INDIGENT 

12 PATIENTS 

13 SEC. 201. IMPROVING ACCESS FOR RURAL AND INDIGENT 

14 PATIENTS. 

15 (a) LOAN FORGIVENESS FOR PRIMARY CARE PRO16 VIDERS.— 

17 (1) IN GENERAL.—The Secretary of Health and 

18 Human Services shall carry out a program of enter19 ing into contracts with eligible individuals under 

20 which— 

21 (A) the individual agrees to serve for a pe22 riod of not less than 4 years as a primary care 

23 provider in a medically underserved community 

24 (as defined in section 799B of the Public 

25 Health Service Act (42 U.S.C. 295p)); and 


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1 (B) in consideration of such service, the 

2 Secretary agrees to pay not more than 

3 $100,000 on the principal and interest on the 

4 individual’s graduate educational loans. 

5 (2) ELIGIBILITY.—To be eligible to enter into a 

6 contract under subsection (1), an individual must— 

7 (A) have a graduate degree in medicine, 

8 osteopathic medicine, or another health profes9 sion from an accredited (as determined by the 

10 Secretary of Health and Human Services) insti11 tution of higher education; and 

12 (B) have practiced as a primary care pro13 vider for a period (excluding any residency or 

14 fellowship training period) of not less than 3 

15 years in a medically underserved community (as 

16 defined in section 799B of the Public Health 

17 Service Act (42 U.S.C. 295p)). 

18 (3) INSTALLMENTS.—Payments under this sec19 tion may be made in installments of not more than 

20 $25,000 for each year of service described in para21 graph (1) (A). 

22 (4) APPLICABILITY OF CERTAIN PROVISIONS.— 

23 The provisions of subpart III of part D of title III 

24 of the Public Health Service Act shall, except as in25 consistent with this section, apply to the program esVerDate Nov 24 2008 04:12 Aug 04, 2009 Jkt 079200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6201 E:\BILLS\H3483.IH H3483

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1 tablished under this section in the same manner and 

2 to the same extent as such provisions apply to the 

3 National Health Service Corps Loan Repayment 

4 Program established in such subpart. 

5 (b) PERMITTING STATE DESIGNATION OF CRITICAL

6 ACCESS HOSPITALS.—Section 1820(c)(2)(B)(i)(II) of the 

7 Social Security Act (42 U.S.C. 1395i–4(c)(2)(B)(i)(II)) is 

8 amended by inserting ‘‘or on or after the date of enact9 ment of the Steps Toward Access and Reform Act of 

10 2009’’ after ‘‘January 1, 2006,’’. 

11 (c) PATIENT FAIRNESS AND INDIGENT CARE PRO12 MOTION.— 

13 (1) IN GENERAL.—Section 166 of the Internal 

14 Revenue Code of 1986 (relating to bad debts) is 

15 amended by redesignating subsection (f) as sub16 section (g) and by inserting after subsection (e) the 

17 following new subsection: 

18 ‘‘(f) UNPAID MEDICAL CARE PROVIDED TO LOW-IN19 COME INDIVIDUALS.— 

20 ‘‘(1) IN GENERAL.—In the case of a taxpayer 

21 to whom this subsection applies, the deduction under 

22 subsection (a) for worthless qualified medical care 

23 debt shall not be less than 75 percent of the tax24 payer’s charge for such care. 


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1 ‘‘(2) TAXPAYER TO WHOM SUBSECTION AP2 PLIES.—This subsection shall apply to any taxpayer 

3 who is engaged in the trade or business of providing 

4 medical care other than as an employee and who 

5 used the cash receipts and disbursements method of 

6 accounting. 

7 ‘‘(3) QUALIFIED MEDICAL CARE DEBT.—For 

8 purposes of this subsection, the term ‘qualified med9 ical care debt’ means any debt for medical care pro10 vided by the taxpayer to a low-income individual who 

11 is a citizen or legal resident of the United States. 

12 ‘‘(4) DETERMINATION OF CHARGE.—The 

13 amount of the taxpayer’s charge which may be taken 

14 into account— 

15 ‘‘(A) shall not exceed the amount of the 

16 charge that would be recognized for purposes of 

17 title XVIII of the Social Security Act, and 

18 ‘‘(B) shall not include any amount for 

19 which the taxpayer is not entitled to reimburse20 ment from the low-income individual. 

21 ‘‘(5) LOW-INCOME INDIVIDUAL.—For purposes 

22 of this subsection, the term ‘low-income individual’ 

23 means an individual who, at the time the medical 

24 care attributable to the debt is provided, has an an25 nual household income below 135 percent of the povVerDate Nov 24 2008 04:12 Aug 04, 2009 Jkt 079200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\H3483.IH H3483

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1 erty line (as defined in section 673 of the Commu2 nity Services Block Grant Act (42 U.S.C. 9902)) ap3 plicable to the size of the family involved, and is a 

4 citizen or legal resident of the United States. 

5 ‘‘(6) MEDICAL CARE.—For purposes of this 

6 subsection, the term ‘medical care’ has the meaning 

7 given to such term by section 213(d). 

8 ‘‘(7) REGULATIONS.—The Secretary shall pre9 scribe such regulations as may be necessary or ap10 propriate to carry out this section, including regula11 tions providing for methods of establishing that an 

12 individual is a low-income individual for purposes of 

13 this section.’’ 

14 (2) EFFECTIVE DATE.—The amendment made 

15 by this section shall apply to taxable years beginning 

16 after the date of the enactment of this Act. 


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1 TITLE III—PROMOTING AFFORD2 ABLE PRESCRIPTION DRUGS 

3 BY DEFINING OBJECTIVES IN 

4 NEGOTIATION OF TRADE 

5 AGREEMENTS 

6 SEC. 301. PROMOTING AFFORDABLE PRESCRIPTION DRUGS 

7 BY DEFINING OBJECTIVES IN NEGOTIATION 

8 OF TRADE AGREEMENTS. 

9 (a) IN GENERAL.—Section 2102(a) of the Bipartisan 

10 Trade Promotion Authority Act of 2002 (19 U.S.C. 

11 3802(a)) is amended— 

12 (1) by striking ‘‘and’’ at the end of paragraph 

13 (8); 

14 (2) by striking the period at the end of para15 graph (9) and inserting ‘‘; and’’; and 

16 (3) by adding at the end the following: 

17 ‘‘(10) to avoid negotiating trade agreements 

18 that could restrict, or be interpreted to restrict, the 

19 access of consumers in the United States to pharma20 ceutical imports from countries with a pharma21 ceutical infrastructure that is equivalent, or supe22 rior, to that of the United States— 

23 ‘‘(A) by or through the use and develop24 ment of the doctrine of international patent ex25 haustion, as interpreted or applied by United 


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1 States courts on the date of enactment of this 

2 Act; or 

3 ‘‘(B) by making it a violation for the 

4 United States to enact legislation permitting 

5 pharmaceutical imports without the consent of 

6 patent owners when the products involved have 

7 been sold outside the United States.’’. 

8 (b) CERTAIN PROHIBITIONS.—Notwithstanding any 

9 other provision of law, the United States Trade Represent10 ative— 

11 (1) may not enter into a bilateral or multilat12 eral trade agreement that, with respect to the impor13 tation of pharmaceutical products without the con14 sent of the patent owners, includes provisions that 

15 are the same or similar to the provisions of— 

16 (A) paragraph 2 of Article 16.7 of the 

17 United States-Singapore Free Trade Agree18 ment; 

19 (B) paragraph 4 of Article 17.9 of the 

20 United States-Australia Free Trade Agreement; 

21 or 

22 (C) paragraph 4 of Article 15.9 of the 

23 United States-Morocco Free Trade Agreement; 

24 and 


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1 (2) may not, with respect to the importation of 

2 pharmaceutical products without the consent of the 

3 patent owners, negotiate an agreement or under4 standing with respect to any of the provisions re5 ferred to in paragraph (1). 

6 TITLE IV—ENCOURAGING 

7 PREVENTATIVE CARE 

8 SEC. 401. ENCOURAGING PREVENTATIVE CARE. 

9 (a) MOBILE MAMMOGRAPHY PROMOTION.— 

10 (1) REFUNDS.—Section 6427 of the Internal 

11 Revenue Code of 1986 (relating to fuels not used for 

12 taxable purposes) is amended by inserting after sub13 section (f) the following new subsection: 

14 ‘‘(g) FUELS USED IN MOBILE MAMMOGRAPHY VEHI15 CLES.—Except as provided in subsection (k), if any fuel 

16 on which tax was imposed by section 4041 or 4081 is used 

17 in any highway vehicle designed exclusively to provide mo18 bile mammography services to patients within such vehi19 cle, the Secretary shall pay (without interest) to the ulti20 mate purchaser of such fuel an amount equal to the aggre21 gate amount of the tax imposed on such fuel.’’. 

22 (2) EXEMPTION FROM RETAIL TAX.—Section 

23 4041 of such Code is amended by adding at the end 

24 the following new subsection: 


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1 ‘‘(n) FUELS USED IN MOBILE MAMMOGRAPHY VEHI2 CLES.—No tax shall be imposed under this section on any 

3 liquid sold for use in, or used in, any highway vehicle de4 signed exclusively to provide mobile mammography serv5 ices to patients within such vehicle.’’. 

6 (3) EFFECTIVE DATE.—The amendments made 

7 by this section shall take effect on the date of the 

8 enactment of this Act. 

9 (b) MEDICARE LUNG CANCER EARLY DETECTION.— 

10 Section 1834 of the Social Security Act (42 U.S.C. 

11 1395m) is amended— 

12 (1) in subsection (b)(1)(B), by striking ‘‘sub13 section (c)(1)(A)’’ and inserting ‘‘subsections 

14 (c)(1)(A) and (n)’’; and 

15 (2) by adding at the end the following new sub16 section: 

17 ‘‘(n) PAYMENT FOR CHEST RADIOGRAPHY SERVICES

18 THAT USE COMPUTER AIDED DETECTION TECHNOLOGY

19 FOR THE EARLY DETECTION OF LUNG CANCER.— 

20 ‘‘(1) IN GENERAL.—Notwithstanding any other 

21 provision of this part, with respect to chest radiog22 raphy services (identified as of September 1, 2006, 

23 by HCPCS codes 71010, 71020, 71021, 71022, and 

24 71030, and as subsequently modified by the Sec25 retary) furnished on or after January 1, 2010, that 


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1 use Computer Aided Detection technology for the 

2 early detection of lung cancer (as defined in para3 graph (4)), the amount of payment shall be equal 

4 to— 

5 ‘‘(A) with respect to the technical compo6 nent of such services— 

7 ‘‘(i) the amount of payment under the 

8 fee schedule established under section 

9 1848 for such component for the year that 

10 would otherwise apply; plus 

11 ‘‘(ii) the amount described in para12 graph (2); and 

13 ‘‘(B) with respect to the professional com14 ponent of such services— 

15 ‘‘(i) the amount of payment under the 

16 fee schedule established under section 

17 1848 for such component for the year that 

18 would otherwise apply; plus 

19 ‘‘(ii) the amount described in para20 graph (3). 

21 ‘‘(2) AMOUNT DESCRIBED FOR TECHNICAL

22 COMPONENT.—The amount described in this para23 graph for services furnished— 

24 ‘‘(A) during 2010 is $12; or 


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1 ‘‘(B) during a subsequent year is the 

2 amount established under this paragraph for 

3 the preceding year, increased by the update de4 termined under section 1848(d) for the year. 

5 ‘‘(3) AMOUNT DESCRIBED FOR PROFESSIONAL

6 COMPONENT.—The amount described in this para7 graph for services furnished— 

8 ‘‘(A) during 2010 is $4; and 

9 ‘‘(B) during a subsequent year is the 

10 amount established under this paragraph for 

11 the preceding year increased by the update de12 termined under section 1848(d) for the year. 

13 ‘‘(4) COMPUTER AIDED DETECTION TECH14 NOLOGY FOR THE EARLY DETECTION OF LUNG CAN15 CER DEFINED.—In this subsection, the term ‘Com16 puter Aided Detection technology for the early detec17 tion of lung cancer’ means a computer software 

18 technology which allows for the production of a dig19 ital chest x-ray image or the conversion of a chest 

20 x-ray into a digital image to be subsequently ana21 lyzed for early lung cancer nodules and which the 

22 Food and Drug Administration has granted approval 

23 or clearance. 

24 ‘‘(5) NEW CODES.—The Secretary shall estab25 lish new codes for chest radiography services deVerDate Nov 24 2008 04:12 Aug 04, 2009 Jkt 079200 PO 00000 Frm 00034 Fmt 6652 Sfmt 6201 E:\BILLS\H3483.IH H3483

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1 scribed in paragraph (1) in order to implement this 

2 subsection.’’. 

3 (c) VETERANS TRAVEL TAX RELIEF.— 

4 (1) IN GENERAL.—Part VII of subchapter B of 

5 chapter I of the Internal Revenue Code of 1986 (re6 lating to additional itemized deductions for individ7 uals) is amended by redesignating section 224 as 

8 section 225, and by inserting after section 223 the 

9 following new section: 

10 ‘‘SEC. 224. TRAVEL EXPENSES OF VETERANS FOR HEALTH 

11 CARE AT MEDICAL CENTERS OF THE DE12 PARTMENT OF VETERANS AFFAIRS. 

13 ‘‘(a) ALLOWANCE OF DEDUCTION.—In the case of an 

14 individual, there shall be allowed as a deduction the quali15 fied travel expenses for the taxable year. 

16 ‘‘(b) LIMITATIONS.— 

17 ‘‘(1) DOLLAR LIMITATION.—The amount al18 lowed as a deduction under subsection (a) for a tax19 able year shall not exceed $400. 

20 ‘‘(2) LIMITATION BASED ON ADJUSTED GROSS

21 INCOME.—The amount allowable as a deduction 

22 under subsection (a) shall be reduced (but not below 

23 zero) by an amount which bears the same ratio to 

24 the amount so allowable (determined without regard 


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1 to this paragraph but with regard to paragraph (1)) 

2 as— 

3 ‘‘(A) the amount (if any) by which the tax4 payer’s adjusted gross income exceeds $75,000 

5 ($150,000 in the case of a joint return), bears 

6 to 

7 ‘‘(B) $10,000 ($20,000 in the case of a 

8 joint return). 

9 ‘‘(3) ADJUSTMENTS FOR INFLATION.—In the 

10 case of a taxable year beginning after 2009, each of 

11 the dollar amounts in paragraph (2) shall be in12 creased by an amount equal to— 

13 ‘‘(A) such dollar amount, multiplied by 

14 ‘‘(B) the cost-of-living adjustment deter15 mined under section 1(f)(3) for the calendar 

16 year in which the taxable year begins, deter17 mined by substituting ‘calendar year 2008’ for 

18 ‘calendar year 1992’ in subparagraph (B) 

19 thereof. 

20 If any amount as increased under the preceding sen21 tence is not a multiple of $100, such amount shall 

22 be rounded to the nearest multiple of $100. 

23 ‘‘(c) QUALIFIED TRAVEL EXPENSES.—For purposes 

24 of this section— 


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1 ‘‘(1) IN GENERAL.—The term ‘qualified travel 

2 expenses’ means amounts paid for travel expenses of 

3 a veteran and a family member of the veteran to a 

4 medical center of the Department of Veterans Af5 fairs for— 

6 ‘‘(A) treatment relating to a service-con7 nected disability, or 

8 ‘‘(B) examination conducted by the Sec9 retary of Veterans Affairs relating to a claim 

10 for disability compensation or pension under 

11 the laws administered by the Secretary of Vet12 erans Affairs. 

13 ‘‘(2) REIMBURSEMENTS BY DEPARTMENT OF

14 VETERANS AFFAIRS.—The term ‘qualified travel ex15 penses’ does not include any travel expense which is 

16 reimbursed by the Department of Veterans Affairs 

17 or any other insurance plan. 

18 ‘‘(3) LIMITATION.—Travel expenses incurred by 

19 a veteran shall not be taken into account under 

20 paragraph (1) unless— 

21 ‘‘(A) the principal place of abode of the 

22 veteran is more than 25 miles from the medical 

23 center in which the treatment is provided or ex24 amination conducted, and 


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1 ‘‘(B) such medical center is the nearest 

2 medical center of the Department of Veterans 

3 Affairs to such place of abode. 

4 ‘‘(4) TRAVEL EXPENSES.—The term ‘travel ex5 penses’ includes transportation, food, and lodging. 

6 ‘‘(d) OTHER DEFINITIONS.—For purposes of this 

7 section— 

8 ‘‘(1) VETERAN.—The term ‘veteran’ has the 

9 meaning given such term by section 101(2) of title 

10 38, United States Code. 

11 ‘‘(2) SERVICE-CONNECTED DISABILITY.—The 

12 term ‘service-connected disability’ has the meaning 

13 given such term under section 101(13) of such Code. 

14 ‘‘(3) FAMILY MEMBER.—The members of an in15 dividual’s family shall be determined under section 

16 4946(d); except that such members also shall in17 clude the brothers and sisters (whether by the whole 

18 or half blood) of the individual and their spouses.’’. 

19 (2) DEDUCTION ALLOWED WHETHER OR NOT

20 TAXPAYER ITEMIZES OTHER DEDUCTIONS.—Sub21 section (a) of section 62 of such Code (defining ad22 justed gross income) is amended by inserting before 

23 the last sentence the following new paragraph: 

24 ‘‘(22) TRAVEL EXPENSES OF VETERANS FOR

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1 PARTMENT OF VETERANS AFFAIRS.—The deduction 

2 allowed by section 224.’’. 

3 (3) CLERICAL AMENDMENTS.—The table of sec4 tions for part VII of subchapter B of chapter 1 of 

5 such Code is amended by striking the item relating 

6 to section 224 and inserting the following: 

‘‘Sec. 224. Travel expenses of veterans for health care at medical centers of the 

Department of Veterans Affairs. 

‘‘Sec. 225. Cross reference.’’. 

7 (4) EFFECTIVE DATE.—The amendments made 

8 by this section shall apply to taxable years beginning 

9 after December 31, 2008. 

Æ 


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