II 

108TH CONGRESS 

1ST SESSION S. 1945

To amend the Public Health Service Act and the Employee Retirement 

Income Security Act of 1974 to protect consumers in managed care 

plans and other health coverage. 

IN THE SENATE OF THE UNITED STATES 

NOVEMBER 24, 2003

Mr. MCCAIN (for himself, Mr. EDWARDS, and Mr. KENNEDY) introduced the 

following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

A BILL

To amend the Public Health Service Act and the Employee 

Retirement Income Security Act of 1974 to protect consumers in managed care plans and other health coverage.

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 ‘‘Bipartisan Patient Protection Act’’. 

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

7 this Act is as follows:

Sec. 1. Short title; table of contents. 

TITLE I—IMPROVING MANAGED CARE 
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Subtitle A—Utilization Review; Claims; and Internal and External Appeals 

Sec. 101. Utilization review activities. 

Sec. 102. Procedures for initial claims for benefits and prior authorization determinations. 

Sec. 103. Internal appeals of claims denials. 

Sec. 104. Independent external appeals procedures. 

Sec. 105. Health care consumer assistance fund. 

Subtitle B—Access to Care 

Sec. 111. Consumer choice option. 

Sec. 112. Choice of health care professional. 

Sec. 113. Access to emergency care. 

Sec. 114. Timely access to specialists. 

Sec. 115. Patient access to obstetrical and gynecological care. 

Sec. 116. Access to pediatric care. 

Sec. 117. Continuity of care. 

Sec. 118. Access to needed prescription drugs. 

Sec. 119. Coverage for individuals participating in approved clinical trials. 

Sec. 120. Required coverage for minimum hospital stay for mastectomies and 

lymph node dissections for the treatment of breast cancer and 

coverage for secondary consultations. 

Subtitle C—Access to Information 

Sec. 121. Patient access to information. 

Subtitle D—Protecting the Doctor-Patient Relationship 

Sec. 131. Prohibition of interference with certain medical communications. 

Sec. 132. Prohibition of discrimination against providers based on licensure. 

Sec. 133. Prohibition against improper incentive arrangements. 

Sec. 134. Payment of claims. 

Sec. 135. Protection for patient advocacy. 

Subtitle E—Definitions 

Sec. 151. Definitions. 

Sec. 152. Preemption; State flexibility; construction. 

Sec. 153. Exclusions. 

Sec. 154. Coverage of limited scope plans. 

Sec. 155. Regulations. 

Sec. 156. Incorporation into plan or coverage documents. 

Sec. 157. Preservation of protections. 

TITLE II—APPLICATION OF QUALITY CARE STANDARDS TO 

GROUP HEALTH PLANS AND HEALTH INSURANCE COVERAGE 

UNDER THE PUBLIC HEALTH SERVICE ACT 

Sec. 201. Application to group health plans and group health insurance coverage. 

Sec. 202. Application to individual health insurance coverage. 

Sec. 203. Cooperation between Federal and State authorities. 

TITLE III—APPLICATION OF PATIENT PROTECTION STANDARDS 

TO FEDERAL HEALTH CARE PROGRAMS 
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Sec. 301. Application of patient protection standards to Federal health care 

programs. 

TITLE IV—AMENDMENTS TO THE EMPLOYEE RETIREMENT 

INCOME SECURITY ACT OF 1974

Sec. 401. Application of patient protection standards to group health plans and 

group health insurance coverage under the Employee Retirement Income Security Act of 1974. 

Sec. 402. Availability of civil remedies. 

Sec. 403. Limitation on certain class action litigation. 

Sec. 404. Limitations on actions. 

Sec. 405. Cooperation between Federal and State authorities. 

Sec. 406. Sense of the Senate concerning the importance of certain unpaid 

services. 

TITLE V—EFFECTIVE DATES; COORDINATION IN 

IMPLEMENTATION 

Sec. 501. Effective dates. 

Sec. 502. Coordination in implementation. 

Sec. 503. Severability. 

TITLE VI—MISCELLANEOUS PROVISIONS 

Sec. 601. No impact on Social Security Trust Fund. 

Sec. 602. Sense of Senate with respect to participation in clinical trials and access to specialty care. 

Sec. 603. Sense of the Senate regarding fair review process. 

Sec. 604. Annual review.

1 TITLE I—IMPROVING MANAGED 

2 CARE 

3 Subtitle A—Utilization Review; 

4 Claims; and Internal and Exter5 nal Appeals 

6 SEC. 101. UTILIZATION REVIEW ACTIVITIES. 

7 (a) COMPLIANCE WITH REQUIREMENTS.—

8 (1) IN GENERAL.—A group health plan, and a 

9 health insurance issuer that provides health insur10 ance coverage, shall conduct utilization review activi11 ties in connection with the provision of benefits 

12 under such plan or coverage only in accordance with 
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1 a utilization review program that meets the require2 ments of this section and section 102. 

3 (2) USE OF OUTSIDE AGENTS.—Nothing in this 

4 section shall be construed as preventing a group 

5 health plan or health insurance issuer from arrang6 ing through a contract or otherwise for persons or 

7 entities to conduct utilization review activities on be8 half of the plan or issuer, so long as such activities 

9 are conducted in accordance with a utilization review 

10 program that meets the requirements of this section. 

11 (3) UTILIZATION REVIEW DEFINED.—For pur12 poses of this section, the terms ‘‘utilization review’’ 

13 and ‘‘utilization review activities’’ mean procedures 

14 used to monitor or evaluate the use or coverage, 

15 clinical necessity, appropriateness, efficacy, or effi16 ciency of health care services, procedures or settings, 

17 and includes prospective review, concurrent review, 

18 second opinions, case management, discharge plan19 ning, or retrospective review. 

20 (b) WRITTEN POLICIES AND CRITERIA.—

21 (1) WRITTEN POLICIES.—A utilization review 

22 program shall be conducted consistent with written 

23 policies and procedures that govern all aspects of the 

24 program. 

25 (2) USE OF WRITTEN CRITERIA.—
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1 (A) IN GENERAL.—Such a program shall 

2 utilize written clinical review criteria developed 

3 with input from a range of appropriate actively 

4 practicing health care professionals, as deter5 mined by the plan, pursuant to the program. 

6 Such criteria shall include written clinical re7 view criteria that are based on valid clinical evi8 dence where available and that are directed spe9 cifically at meeting the needs of at-risk popu10 lations and covered individuals with chronic 

11 conditions or severe illnesses, including gender12 specific criteria and pediatric-specific criteria 

13 where available and appropriate. 

14 (B) CONTINUING USE OF STANDARDS IN

15 RETROSPECTIVE REVIEW.—If a health care 

16 service has been specifically pre-authorized or 

17 approved for a participant, beneficiary, or en18 rollee under such a program, the program shall 

19 not, pursuant to retrospective review, revise or 

20 modify the specific standards, criteria, or proce21 dures used for the utilization review for proce22 dures, treatment, and services delivered to the 

23 enrollee during the same course of treatment. 

24 (C) REVIEW OF SAMPLE OF CLAIMS DENI25 ALS.—Such a program shall provide for a peri-
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1 odic evaluation of the clinical appropriateness of 

2 at least a sample of denials of claims for bene3 fits. 

4 (c) CONDUCT OF PROGRAM ACTIVITIES.—

5 (1) ADMINISTRATION BY HEALTH CARE PRO6 FESSIONALS.—A utilization review program shall be 

7 administered by qualified health care professionals 

8 who shall oversee review decisions. 

9 (2) USE OF QUALIFIED, INDEPENDENT PER10 SONNEL.—

11 (A) IN GENERAL.—A utilization review 

12 program shall provide for the conduct of utiliza13 tion review activities only through personnel 

14 who are qualified and have received appropriate 

15 training in the conduct of such activities under 

16 the program. 

17 (B) PROHIBITION OF CONTINGENT COM18 PENSATION ARRANGEMENTS.—Such a program 

19 shall not, with respect to utilization review ac20 tivities, permit or provide compensation or any21 thing of value to its employees, agents, or con22 tractors in a manner that encourages denials of 

23 claims for benefits. 

24 (C) PROHIBITION OF CONFLICTS.—Such a 

25 program shall not permit a health care profes-
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1 sional who is providing health care services to 

2 an individual to perform utilization review ac3 tivities in connection with the health care serv4 ices being provided to the individual. 

5 (3) ACCESSIBILITY OF REVIEW.—Such a pro6 gram shall provide that appropriate personnel per7 forming utilization review activities under the pro8 gram, including the utilization review administrator, 

9 are reasonably accessible by toll-free telephone dur10 ing normal business hours to discuss patient care 

11 and allow response to telephone requests, and that 

12 appropriate provision is made to receive and respond 

13 promptly to calls received during other hours. 

14 (4) LIMITS ON FREQUENCY.—Such a program 

15 shall not provide for the performance of utilization 

16 review activities with respect to a class of services 

17 furnished to an individual more frequently than is 

18 reasonably required to assess whether the services 

19 under review are medically necessary and appro20 priate. 

21 SEC. 102. PROCEDURES FOR INITIAL CLAIMS FOR BENE22 FITS AND PRIOR AUTHORIZATION DETER23 MINATIONS. 

24 (a) PROCEDURES OF INITIAL CLAIMS FOR BENE25 FITS.—
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1 (1) IN GENERAL.—A group health plan, or 

2 health insurance issuer offering health insurance 

3 coverage, shall—

4 (A) make a determination on an initial 

5 claim for benefits by a participant, beneficiary, 

6 or enrollee (or authorized representative) re7 garding payment or coverage for items or serv8 ices under the terms and conditions of the plan 

9 or coverage involved, including any cost-sharing 

10 amount that the participant, beneficiary, or en11 rollee is required to pay with respect to such 

12 claim for benefits; and 

13 (B) notify a participant, beneficiary, or en14 rollee (or authorized representative) and the 

15 treating health care professional involved re16 garding a determination on an initial claim for 

17 benefits made under the terms and conditions 

18 of the plan or coverage, including any cost-shar19 ing amounts that the participant, beneficiary, 

20 or enrollee may be required to make with re21 spect to such claim for benefits, and of the 

22 right of the participant, beneficiary, or enrollee 

23 to an internal appeal under section 103. 

24 (2) ACCESS TO INFORMATION.—
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1 (A) TIMELY PROVISION OF NECESSARY IN2 FORMATION.—With respect to an initial claim 

3 for benefits, the participant, beneficiary, or en4 rollee (or authorized representative) and the 

5 treating health care professional (if any) shall 

6 provide the plan or issuer with access to infor7 mation requested by the plan or issuer that is 

8 necessary to make a determination relating to 

9 the claim. Such access shall be provided not 

10 later than 5 days after the date on which the 

11 request for information is received, or, in a case 

12 described in subparagraph (B) or (C) of sub13 section (b)(1), by such earlier time as may be 

14 necessary to comply with the applicable timeline 

15 under such subparagraph. 

16 (B) LIMITED EFFECT OF FAILURE ON

17 PLAN OR ISSUER’S OBLIGATIONS.—Failure of 

18 the participant, beneficiary, or enrollee to com19 ply with the requirements of subparagraph (A) 

20 shall not remove the obligation of the plan or 

21 issuer to make a decision in accordance with 

22 the medical exigencies of the case and as soon 

23 as possible, based on the available information, 

24 and failure to comply with the time limit estab25 lished by this paragraph shall not remove the
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1 obligation of the plan or issuer to comply with 

2 the requirements of this section. 

3 (3) ORAL REQUESTS.—In the case of a claim 

4 for benefits involving an expedited or concurrent de5 termination, a participant, beneficiary, or enrollee 

6 (or authorized representative) may make an initial 

7 claim for benefits orally, but a group health plan, or 

8 health insurance issuer offering health insurance 

9 coverage, may require that the participant, bene10 ficiary, or enrollee (or authorized representative) 

11 provide written confirmation of such request in a 

12 timely manner on a form provided by the plan or 

13 issuer. In the case of such an oral request for bene14 fits, the making of the request (and the timing of 

15 such request) shall be treated as the making at that 

16 time of a claims for such benefits without regard to 

17 whether and when a written confirmation of such re18 quest is made. 

19 (b) TIMELINE FOR MAKING DETERMINATIONS.—

20 (1) PRIOR AUTHORIZATION DETERMINATION.—

21 (A) IN GENERAL.—A group health plan, or 

22 health insurance issuer offering health insur23 ance coverage, shall make a prior authorization 

24 determination on a claim for benefits (whether 

25 oral or written) in accordance with the medical 
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1 exigencies of the case and as soon as possible, 

2 but in no case later than 14 days from the date 

3 on which the plan or issuer receives information 

4 that is reasonably necessary to enable the plan 

5 or issuer to make a determination on the re6 quest for prior authorization and in no case 

7 later than 28 days after the date of the claim 

8 for benefits is received. 

9 (B) EXPEDITED DETERMINATION.—Not10 withstanding subparagraph (A), a group health 

11 plan, or health insurance issuer offering health 

12 insurance coverage, shall expedite a prior au13 thorization determination on a claim for bene14 fits described in such subparagraph when a re15 quest for such an expedited determination is 

16 made by a participant, beneficiary, or enrollee 

17 (or authorized representative) at any time dur18 ing the process for making a determination and 

19 a health care professional certifies, with the re20 quest, that a determination under the proce21 dures described in subparagraph (A) would seri22 ously jeopardize the life or health of the partici23 pant, beneficiary, or enrollee or the ability of 

24 the participant, beneficiary, or enrollee to main25 tain or regain maximum function. Such deter-
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1 mination shall be made in accordance with the 

2 medical exigencies of the case and as soon as 

3 possible, but in no case later than 72 hours 

4 after the time the request is received by the 

5 plan or issuer under this subparagraph. 

6 (C) ONGOING CARE.—

7 (i) CONCURRENT REVIEW.—

8 (I) IN GENERAL.—Subject to 

9 clause (ii), in the case of a concurrent 

10 review of ongoing care (including hos11 pitalization), which results in a termi12 nation or reduction of such care, the 

13 plan or issuer must provide by tele14 phone and in printed form notice of 

15 the concurrent review determination 

16 to the individual or the individual’s 

17 designee and the individual’s health 

18 care provider in accordance with the 

19 medical exigencies of the case and as 

20 soon as possible, with sufficient time 

21 prior to the termination or reduction 

22 to allow for an appeal under section 

23 103(b)(3) to be completed before the 

24 termination or reduction takes effect. 
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1 (II) CONTENTS OF NOTICE.—

2 Such notice shall include, with respect 

3 to ongoing health care items and serv4 ices, the number of ongoing services 

5 approved, the new total of approved 

6 services, the date of onset of services, 

7 and the next review date, if any, as 

8 well as a statement of the individual’s 

9 rights to further appeal. 

10 (ii) RULE OF CONSTRUCTION.—Clause 

11 (i) shall not be construed as requiring 

12 plans or issuers to provide coverage of care 

13 that would exceed the coverage limitations 

14 for such care. 

15 (2) RETROSPECTIVE DETERMINATION.—A 

16 group health plan, or health insurance issuer offer17 ing health insurance coverage, shall make a retro18 spective determination on a claim for benefits in ac19 cordance with the medical exigencies of the case and 

20 as soon as possible, but not later than 30 days after 

21 the date on which the plan or issuer receives infor22 mation that is reasonably necessary to enable the 

23 plan or issuer to make a determination on the claim, 

24 or, if earlier, 60 days after the date of receipt of the 

25 claim for benefits. 
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1 (c) NOTICE OF A DENIAL OF A CLAIM FOR BENE2 FITS.—Written notice of a denial made under an initial 

3 claim for benefits shall be issued to the participant, bene4 ficiary, or enrollee (or authorized representative) and the 

5 treating health care professional in accordance with the 

6 medical exigencies of the case and as soon as possible, but 

7 in no case later than 2 days after the date of the deter8 mination (or, in the case described in subparagraph (B) 

9 or (C) of subsection (b)(1), within the 72-hour or applica10 ble period referred to in such subparagraph). 

11 (d) REQUIREMENTS OF NOTICE OF DETERMINA12 TIONS.—The written notice of a denial of a claim for bene13 fits determination under subsection (c) shall be provided 

14 in printed form and written in a manner calculated to be 

15 understood by the participant, beneficiary, or enrollee and 

16 shall include—

17 (1) the specific reasons for the determination 

18 (including a summary of the clinical or scientific evi19 dence used in making the determination); 

20 (2) the procedures for obtaining additional in21 formation concerning the determination; and 

22 (3) notification of the right to appeal the deter23 mination and instructions on how to initiate an ap24 peal in accordance with section 103. 

25 (e) DEFINITIONS.—For purposes of this part:
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1 (1) AUTHORIZED REPRESENTATIVE.—The term 

2 ‘‘authorized representative’’ means, with respect to 

3 an individual who is a participant, beneficiary, or en4 rollee, any health care professional or other person 

5 acting on behalf of the individual with the individ6 ual’s consent or without such consent if the indi7 vidual is medically unable to provide such consent. 

8 (2) CLAIM FOR BENEFITS.—The term ‘‘claim 

9 for benefits’’ means any request for coverage (in10 cluding authorization of coverage), for eligibility, or 

11 for payment in whole or in part, for an item or serv12 ice under a group health plan or health insurance 

13 coverage. 

14 (3) DENIAL OF CLAIM FOR BENEFITS.—The 

15 term ‘‘denial’’ means, with respect to a claim for 

16 benefits, a denial (in whole or in part) of, or a fail17 ure to act on a timely basis upon, the claim for ben18 efits and includes a failure to provide benefits (in19 cluding items and services) required to be provided 

20 under this title. 

21 (4) TREATING HEALTH CARE PROFESSIONAL.—

22 The term ‘‘treating health care professional’’ means, 

23 with respect to services to be provided to a partici24 pant, beneficiary, or enrollee, a health care profes25 sional who is primarily responsible for delivering 
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1 those services to the participant, beneficiary, or en2 rollee. 

3 SEC. 103. INTERNAL APPEALS OF CLAIMS DENIALS. 

4 (a) RIGHT TO INTERNAL APPEAL.—

5 (1) IN GENERAL.—A participant, beneficiary, or 

6 enrollee (or authorized representative) may appeal 

7 any denial of a claim for benefits under section 102 

8 under the procedures described in this section. 

9 (2) TIME FOR APPEAL.—

10 (A) IN GENERAL.—A group health plan, or 

11 health insurance issuer offering health insur12 ance coverage, shall ensure that a participant, 

13 beneficiary, or enrollee (or authorized represent14 ative) has a period of not less than 180 days 

15 beginning on the date of a denial of a claim for 

16 benefits under section 102 in which to appeal 

17 such denial under this section. 

18 (B) DATE OF DENIAL.—For purposes of 

19 subparagraph (A), the date of the denial shall 

20 be deemed to be the date as of which the partic21 ipant, beneficiary, or enrollee knew of the denial 

22 of the claim for benefits. 

23 (3) FAILURE TO ACT.—The failure of a plan or 

24 issuer to issue a determination on a claim for bene25 fits under section 102 within the applicable timeline 
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1 established for such a determination under such sec2 tion is a denial of a claim for benefits for purposes 

3 this subtitle as of the date of the applicable deadline. 

4 (4) PLAN WAIVER OF INTERNAL REVIEW.—A 

5 group health plan, or health insurance issuer offer6 ing health insurance coverage, may waive the inter7 nal review process under this section. In such case 

8 the plan or issuer shall provide notice to the partici9 pant, beneficiary, or enrollee (or authorized rep10 resentative) involved, the participant, beneficiary, or 

11 enrollee (or authorized representative) involved shall 

12 be relieved of any obligation to complete the internal 

13 review involved, and may, at the option of such par14 ticipant, beneficiary, enrollee, or representative pro15 ceed directly to seek further appeal through external 

16 review under section 104 or otherwise. 

17 (b) TIMELINES FOR MAKING DETERMINATIONS.—

18 (1) ORAL REQUESTS.—In the case of an appeal 

19 of a denial of a claim for benefits under this section 

20 that involves an expedited or concurrent determina21 tion, a participant, beneficiary, or enrollee (or au22 thorized representative) may request such appeal 

23 orally. A group health plan, or health insurance 

24 issuer offering health insurance coverage, may re25 quire that the participant, beneficiary, or enrollee 
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1 (or authorized representative) provide written con2 firmation of such request in a timely manner on a 

3 form provided by the plan or issuer. In the case of 

4 such an oral request for an appeal of a denial, the 

5 making of the request (and the timing of such re6 quest) shall be treated as the making at that time 

7 of a request for an appeal without regard to whether 

8 and when a written confirmation of such request is 

9 made. 

10 (2) ACCESS TO INFORMATION.—

11 (A) TIMELY PROVISION OF NECESSARY IN12 FORMATION.—With respect to an appeal of a 

13 denial of a claim for benefits, the participant, 

14 beneficiary, or enrollee (or authorized represent15 ative) and the treating health care professional 

16 (if any) shall provide the plan or issuer with ac17 cess to information requested by the plan or 

18 issuer that is necessary to make a determina19 tion relating to the appeal. Such access shall be 

20 provided not later than 5 days after the date on 

21 which the request for information is received, 

22 or, in a case described in subparagraph (B) or 

23 (C) of paragraph (3), by such earlier time as 

24 may be necessary to comply with the applicable 

25 timeline under such subparagraph. 
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1 (B) LIMITED EFFECT OF FAILURE ON

2 PLAN OR ISSUER’S OBLIGATIONS.—Failure of 

3 the participant, beneficiary, or enrollee to com4 ply with the requirements of subparagraph (A) 

5 shall not remove the obligation of the plan or 

6 issuer to make a decision in accordance with 

7 the medical exigencies of the case and as soon 

8 as possible, based on the available information, 

9 and failure to comply with the time limit estab10 lished by this paragraph shall not remove the 

11 obligation of the plan or issuer to comply with 

12 the requirements of this section. 

13 (3) PRIOR AUTHORIZATION DETERMINA14 TIONS.—

15 (A) IN GENERAL.—A group health plan, or 

16 health insurance issuer offering health insur17 ance coverage, shall make a determination on 

18 an appeal of a denial of a claim for benefits 

19 under this subsection in accordance with the 

20 medical exigencies of the case and as soon as 

21 possible, but in no case later than 14 days from 

22 the date on which the plan or issuer receives in23 formation that is reasonably necessary to enable 

24 the plan or issuer to make a determination on 

25 the appeal and in no case later than 28 days
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1 after the date the request for the appeal is re2 ceived. 

3 (B) EXPEDITED DETERMINATION.—Not4 withstanding subparagraph (A), a group health 

5 plan, or health insurance issuer offering health 

6 insurance coverage, shall expedite a prior au7 thorization determination on an appeal of a de8 nial of a claim for benefits described in sub9 paragraph (A), when a request for such an ex10 pedited determination is made by a participant, 

11 beneficiary, or enrollee (or authorized represent12 ative) at any time during the process for mak13 ing a determination and a health care profes14 sional certifies, with the request, that a deter15 mination under the procedures described in sub16 paragraph (A) would seriously jeopardize the 

17 life or health of the participant, beneficiary, or 

18 enrollee or the ability of the participant, bene19 ficiary, or enrollee to maintain or regain max20 imum function. Such determination shall be 

21 made in accordance with the medical exigencies 

22 of the case and as soon as possible, but in no 

23 case later than 72 hours after the time the re24 quest for such appeal is received by the plan or 

25 issuer under this subparagraph. 
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1 (C) ONGOING CARE DETERMINATIONS.—

2 (i) IN GENERAL.—Subject to clause 

3 (ii), in the case of a concurrent review de4 termination described in section 

5 102(b)(1)(C)(i)(I), which results in a ter6 mination or reduction of such care, the 

7 plan or issuer must provide notice of the 

8 determination on the appeal under this 

9 section by telephone and in printed form to 

10 the individual or the individual’s designee 

11 and the individual’s health care provider in 

12 accordance with the medical exigencies of 

13 the case and as soon as possible, with suf14 ficient time prior to the termination or re15 duction to allow for an external appeal 

16 under section 104 to be completed before 

17 the termination or reduction takes effect. 

18 (ii) RULE OF CONSTRUCTION.—Clause 

19 (i) shall not be construed as requiring 

20 plans or issuers to provide coverage of care 

21 that would exceed the coverage limitations 

22 for such care. 

23 (4) RETROSPECTIVE DETERMINATION.—A 

24 group health plan, or health insurance issuer offer25 ing health insurance coverage, shall make a retro-
22

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1 spective determination on an appeal of a claim for 

2 benefits in no case later than 30 days after the date 

3 on which the plan or issuer receives necessary infor4 mation that is reasonably necessary to enable the 

5 plan or issuer to make a determination on the ap6 peal and in no case later than 60 days after the date 

7 the request for the appeal is received. 

8 (c) CONDUCT OF REVIEW.—

9 (1) IN GENERAL.—A review of a denial of a 

10 claim for benefits under this section shall be con11 ducted by an individual with appropriate expertise 

12 who was not involved in the initial determination. 

13 (2) PEER REVIEW OF MEDICAL DECISIONS BY

14 HEALTH CARE PROFESSIONALS.—A review of an ap15 peal of a denial of a claim for benefits that is based 

16 on a lack of medical necessity and appropriateness, 

17 or based on an experimental or investigational treat18 ment, or requires an evaluation of medical facts—

19 (A) shall be made by a physician 

20 (allopathic or osteopathic); or 

21 (B) in a claim for benefits provided by a 

22 non-physician health professional, shall be made 

23 by reviewer (or reviewers) including at least one 

24 practicing non-physician health professional of 

25 the same or similar specialty; 
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1 with appropriate expertise (including, in the case of 

2 a child, appropriate pediatric expertise) and acting 

3 within the appropriate scope of practice within the 

4 State in which the service is provided or rendered, 

5 who was not involved in the initial determination. 

6 (d) NOTICE OF DETERMINATION.—

7 (1) IN GENERAL.—Written notice of a deter8 mination made under an internal appeal of a denial 

9 of a claim for benefits shall be issued to the partici10 pant, beneficiary, or enrollee (or authorized rep11 resentative) and the treating health care professional 

12 in accordance with the medical exigencies of the case 

13 and as soon as possible, but in no case later than 

14 2 days after the date of completion of the review (or, 

15 in the case described in subparagraph (B) or (C) of 

16 subsection (b)(3), within the 72-hour or applicable 

17 period referred to in such subparagraph). 

18 (2) FINAL DETERMINATION.—The decision by a 

19 plan or issuer under this section shall be treated as 

20 the final determination of the plan or issuer on a de21 nial of a claim for benefits. The failure of a plan or 

22 issuer to issue a determination on an appeal of a de23 nial of a claim for benefits under this section within 

24 the applicable timeline established for such a deter25 mination shall be treated as a final determination on 
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1 an appeal of a denial of a claim for benefits for pur2 poses of proceeding to external review under section 

3 104. 

4 (3) REQUIREMENTS OF NOTICE.—With respect 

5 to a determination made under this section, the no6 tice described in paragraph (1) shall be provided in 

7 printed form and written in a manner calculated to 

8 be understood by the participant, beneficiary, or en9 rollee and shall include— 

10 (A) the specific reasons for the determina11 tion (including a summary of the clinical or sci12 entific evidence used in making the determina13 tion); 

14 (B) the procedures for obtaining additional 

15 information concerning the determination; and 

16 (C) notification of the right to an inde17 pendent external review under section 104 and 

18 instructions on how to initiate such a review. 

19 SEC. 104. INDEPENDENT EXTERNAL APPEALS PROCE20 DURES. 

21 (a) RIGHT TO EXTERNAL APPEAL.—A group health 

22 plan, and a health insurance issuer offering health insur23 ance coverage, shall provide in accordance with this sec24 tion participants, beneficiaries, and enrollees (or author-
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1 ized representatives) with access to an independent exter2 nal review for any denial of a claim for benefits. 

3 (b) INITIATION OF THE INDEPENDENT EXTERNAL

4 REVIEW PROCESS.—

5 (1) TIME TO FILE.—A request for an inde6 pendent external review under this section shall be 

7 filed with the plan or issuer not later than 180 days 

8 after the date on which the participant, beneficiary, 

9 or enrollee receives notice of the denial under section 

10 103(d) or notice of waiver of internal review under 

11 section 103(a)(4) or the date on which the plan or 

12 issuer has failed to make a timely decision under 

13 section 103(d)(2) and notifies the participant or 

14 beneficiary that it has failed to make a timely deci15 sion and that the beneficiary must file an appeal 

16 with an external review entity within 180 days if the 

17 participant or beneficiary desires to file such an ap18 peal. 

19 (2) FILING OF REQUEST.—

20 (A) IN GENERAL.—Subject to the suc21 ceeding provisions of this subsection, a group 

22 health plan, and a health insurance issuer offer23 ing health insurance coverage, may—
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•S 1945 IS 

1 (i) except as provided in subparagraph 

2 (B)(i), require that a request for review be 

3 in writing; 

4 (ii) limit the filing of such a request 

5 to the participant, beneficiary, or enrollee 

6 involved (or an authorized representative); 

7 (iii) except if waived by the plan or 

8 issuer under section 103(a)(4), condition 

9 access to an independent external review 

10 under this section upon a final determina11 tion of a denial of a claim for benefits 

12 under the internal review procedure under 

13 section 103; 

14 (iv) except as provided in subpara15 graph (B)(ii), require payment of a filing 

16 fee to the plan or issuer of a sum that does 

17 not exceed $25; and 

18 (v) require that a request for review 

19 include the consent of the participant, ben20 eficiary, or enrollee (or authorized rep21 resentative) for the release of necessary 

22 medical information or records of the par23 ticipant, beneficiary, or enrollee to the 

24 qualified external review entity only for 
27

•S 1945 IS 

1 purposes of conducting external review ac2 tivities. 

3 (B) REQUIREMENTS AND EXCEPTION RE4 LATING TO GENERAL RULE.—

5 (i) ORAL REQUESTS PERMITTED IN

6 EXPEDITED OR CONCURRENT CASES.—In 

7 the case of an expedited or concurrent ex8 ternal review as provided for under sub9 section (e), the request may be made oral10 ly. A group health plan, or health insur11 ance issuer offering health insurance cov12 erage, may require that the participant, 

13 beneficiary, or enrollee (or authorized rep14 resentative) provide written confirmation 

15 of such request in a timely manner on a 

16 form provided by the plan or issuer. Such 

17 written confirmation shall be treated as a 

18 consent for purposes of subparagraph 

19 (A)(v). In the case of such an oral request 

20 for such a review, the making of the re21 quest (and the timing of such request) 

22 shall be treated as the making at that time 

23 of a request for such an external review 

24 without regard to whether and when a 
28

•S 1945 IS 

1 written confirmation of such request is 

2 made. 

3 (ii) EXCEPTION TO FILING FEE RE4 QUIREMENT.—

5 (I) INDIGENCY.—Payment of a 

6 filing fee shall not be required under 

7 subparagraph (A)(iv) where there is a 

8 certification (in a form and manner 

9 specified in guidelines established by 

10 the appropriate Secretary) that the 

11 participant, beneficiary, or enrollee is 

12 indigent (as defined in such guide13 lines). 

14 (II) FEE NOT REQUIRED.—Pay15 ment of a filing fee shall not be re16 quired under subparagraph (A)(iv) if 

17 the plan or issuer waives the internal 

18 appeals process under section 

19 103(a)(4). 

20 (III) REFUNDING OF FEE.—The 

21 filing fee paid under subparagraph 

22 (A)(iv) shall be refunded if the deter23 mination under the independent exter24 nal review is to reverse or modify the 
29

•S 1945 IS 

1 denial which is the subject of the re2 view. 

3 (IV) COLLECTION OF FILING

4 FEE.—The failure to pay such a filing 

5 fee shall not prevent the consideration 

6 of a request for review but, subject to 

7 the preceding provisions of this clause, 

8 shall constitute a legal liability to pay. 

9 (c) REFERRAL TO QUALIFIED EXTERNAL REVIEW

10 ENTITY UPON REQUEST.—

11 (1) IN GENERAL.—Upon the filing of a request 

12 for independent external review with the group 

13 health plan, or health insurance issuer offering 

14 health insurance coverage, the plan or issuer shall 

15 immediately refer such request, and forward the 

16 plan or issuer’s initial decision (including the infor17 mation described in section 103(d)(3)(A)), to a 

18 qualified external review entity selected in accord19 ance with this section. 

20 (2) ACCESS TO PLAN OR ISSUER AND HEALTH

21 PROFESSIONAL INFORMATION.—With respect to an 

22 independent external review conducted under this 

23 section, the participant, beneficiary, or enrollee (or 

24 authorized representative), the plan or issuer, and 

25 the treating health care professional (if any) shall 
30

•S 1945 IS 

1 provide the external review entity with information 

2 that is necessary to conduct a review under this sec3 tion, as determined and requested by the entity. 

4 Such information shall be provided not later than 5 

5 days after the date on which the request for infor6 mation is received, or, in a case described in clause 

7 (ii) or (iii) of subsection (e)(1)(A), by such earlier 

8 time as may be necessary to comply with the appli9 cable timeline under such clause. 

10 (3) SCREENING OF REQUESTS BY QUALIFIED

11 EXTERNAL REVIEW ENTITIES.—

12 (A) IN GENERAL.—With respect to a re13 quest referred to a qualified external review en14 tity under paragraph (1) relating to a denial of 

15 a claim for benefits, the entity shall refer such 

16 request for the conduct of an independent med17 ical review unless the entity determines that—

18 (i) any of the conditions described in 

19 clauses (ii) or (iii) of subsection (b)(2)(A) 

20 have not been met; 

21 (ii) the denial of the claim for benefits 

22 does not involve a medically reviewable de23 cision under subsection (d)(2); 

24 (iii) the denial of the claim for bene25 fits relates to a decision regarding whether 
31

•S 1945 IS 

1 an individual is a participant, beneficiary, 

2 or enrollee who is enrolled under the terms 

3 and conditions of the plan or coverage (in4 cluding the applicability of any waiting pe5 riod under the plan or coverage); or 

6 (iv) the denial of the claim for bene7 fits is a decision as to the application of 

8 cost-sharing requirements or the applica9 tion of a specific exclusion or express limi10 tation on the amount, duration, or scope of 

11 coverage of items or services under the 

12 terms and conditions of the plan or cov13 erage unless the decision is a denial de14 scribed in subsection (d)(2). 

15 Upon making a determination that any of clauses (i) 

16 through (iv) applies with respect to the request, the entity 

17 shall determine that the denial of a claim for benefits in18 volved is not eligible for independent medical review under 

19 subsection (d), and shall provide notice in accordance with 

20 subparagraph (C). 

21 (B) PROCESS FOR MAKING DETERMINA22 TIONS.—

23 (i) NO DEFERENCE TO PRIOR DETER24 MINATIONS.—In making determinations 

25 under subparagraph (A), there shall be no
32

•S 1945 IS 

1 deference given to determinations made by 

2 the plan or issuer or the recommendation 

3 of a treating health care professional (if 

4 any). 

5 (ii) USE OF APPROPRIATE PER6 SONNEL.—A qualified external review enti7 ty shall use appropriately qualified per8 sonnel to make determinations under this 

9 section. 

10 (C) NOTICES AND GENERAL TIMELINES

11 FOR DETERMINATION.—

12 (i) NOTICE IN CASE OF DENIAL OF

13 REFERRAL.—If the entity under this para14 graph does not make a referral to an inde15 pendent medical reviewer, the entity shall 

16 provide notice to the plan or issuer, the 

17 participant, beneficiary, or enrollee (or au18 thorized representative) filing the request, 

19 and the treating health care professional 

20 (if any) that the denial is not subject to 

21 independent medical review. Such notice—

22 (I) shall be written (and, in addi23 tion, may be provided orally) in a 

24 manner calculated to be understood 

25 by a participant or enrollee; 
33

•S 1945 IS 

1 (II) shall include the reasons for 

2 the determination; 

3 (III) include any relevant terms 

4 and conditions of the plan or cov5 erage; and 

6 (IV) include a description of any 

7 further recourse available to the indi8 vidual. 

9 (ii) GENERAL TIMELINE FOR DETER10 MINATIONS.—Upon receipt of information 

11 under paragraph (2), the qualified external 

12 review entity, and if required the inde13 pendent medical reviewer, shall make a de14 termination within the overall timeline that 

15 is applicable to the case under review as 

16 described in subsection (e), except that if 

17 the entity determines that a referral to an 

18 independent medical reviewer is not re19 quired, the entity shall provide notice of 

20 such determination to the participant, ben21 eficiary, or enrollee (or authorized rep22 resentative) within such timeline and with23 in 2 days of the date of such determina24 tion. 

25 (d) INDEPENDENT MEDICAL REVIEW.—
34

•S 1945 IS 

1 (1) IN GENERAL.—If a qualified external review 

2 entity determines under subsection (c) that a denial 

3 of a claim for benefits is eligible for independent 

4 medical review, the entity shall refer the denial in5 volved to an independent medical reviewer for the 

6 conduct of an independent medical review under this 

7 subsection. 

8 (2) MEDICALLY REVIEWABLE DECISIONS.—A 

9 denial of a claim for benefits is eligible for inde10 pendent medical review if the benefit for the item or 

11 service for which the claim is made would be a cov12 ered benefit under the terms and conditions of the 

13 plan or coverage but for one (or more) of the fol14 lowing determinations: 

15 (A) DENIALS BASED ON MEDICAL NECES16 SITY AND APPROPRIATENESS.—A determination 

17 that the item or service is not covered because 

18 it is not medically necessary and appropriate or 

19 based on the application of substantially equiva20 lent terms. 

21 (B) DENIALS BASED ON EXPERIMENTAL

22 OR INVESTIGATIONAL TREATMENT.—A deter23 mination that the item or service is not covered 

24 because it is experimental or investigational or 
35

•S 1945 IS 

1 based on the application of substantially equiva2 lent terms. 

3 (C) DENIALS OTHERWISE BASED ON AN

4 EVALUATION OF MEDICAL FACTS.—A deter5 mination that the item or service or condition 

6 is not covered based on grounds that require an 

7 evaluation of the medical facts by a health care 

8 professional in the specific case involved to de9 termine the coverage and extent of coverage of 

10 the item or service or condition. 

11 (3) INDEPENDENT MEDICAL REVIEW DETER12 MINATION.—

13 (A) IN GENERAL.—An independent med14 ical reviewer under this section shall make a 

15 new independent determination with respect to 

16 whether or not the denial of a claim for a ben17 efit that is the subject of the review should be 

18 upheld, reversed, or modified. 

19 (B) STANDARD FOR DETERMINATION.—

20 The independent medical reviewer’s determina21 tion relating to the medical necessity and ap22 propriateness, or the experimental or investiga23 tion nature, or the evaluation of the medical 

24 facts of the item, service, or condition shall be 

25 based on the medical condition of the partici-
36

•S 1945 IS 

1 pant, beneficiary, or enrollee (including the 

2 medical records of the participant, beneficiary, 

3 or enrollee) and valid, relevant scientific evi4 dence and clinical evidence, including peer-re5 viewed medical literature or findings and in6 cluding expert opinion. 

7 (C) NO COVERAGE FOR EXCLUDED BENE8 FITS.—Nothing in this subsection shall be con9 strued to permit an independent medical re10 viewer to require that a group health plan, or 

11 health insurance issuer offering health insur12 ance coverage, provide coverage for items or 

13 services for which benefits are specifically ex14 cluded or expressly limited under the plan or 

15 coverage in the plain language of the plan docu16 ment (and which are disclosed under section 

17 121(b)(1)(C)). Notwithstanding any other pro18 vision of this Act, any exclusion of an exact 

19 medical procedure, any exact time limit on the 

20 duration or frequency of coverage, and any 

21 exact dollar limit on the amount of coverage 

22 that is specifically enumerated and defined (in 

23 the plain language of the plan or coverage docu24 ments) under the plan or coverage offered by a 

25 group health plan or health insurance issuer of-
37

•S 1945 IS 

1 fering health insurance coverage and that is 

2 disclosed under section 121(b)(1) shall be con3 sidered to govern the scope of the benefits that 

4 may be required: Provided, That the terms and 

5 conditions of the plan or coverage relating to 

6 such an exclusion or limit are in compliance 

7 with the requirements of law. 

8 (D) EVIDENCE AND INFORMATION TO BE

9 USED IN MEDICAL REVIEWS.—In making a de10 termination under this subsection, the inde11 pendent medical reviewer shall also consider ap12 propriate and available evidence and informa13 tion, including the following: 

14 (i) The determination made by the 

15 plan or issuer with respect to the claim 

16 upon internal review and the evidence, 

17 guidelines, or rationale used by the plan or 

18 issuer in reaching such determination. 

19 (ii) The recommendation of the treat20 ing health care professional and the evi21 dence, guidelines, and rationale used by 

22 the treating health care professional in 

23 reaching such recommendation. 

24 (iii) Additional relevant evidence or 

25 information obtained by the reviewer or
38

•S 1945 IS 

1 submitted by the plan, issuer, participant, 

2 beneficiary, or enrollee (or an authorized 

3 representative), or treating health care 

4 professional. 

5 (iv) The plan or coverage document. 

6 (E) INDEPENDENT DETERMINATION.—In 

7 making determinations under this subtitle, a 

8 qualified external review entity and an inde9 pendent medical reviewer shall—

10 (i) consider the claim under review 

11 without deference to the determinations 

12 made by the plan or issuer or the rec13 ommendation of the treating health care 

14 professional (if any); and 

15 (ii) consider, but not be bound by the 

16 definition used by the plan or issuer of 

17 ‘‘medically necessary and appropriate’’, or 

18 ‘‘experimental or investigational’’, or other 

19 substantially equivalent terms that are 

20 used by the plan or issuer to describe med21 ical necessity and appropriateness or ex22 perimental or investigational nature of the 

23 treatment. 

24 (F) DETERMINATION OF INDEPENDENT

25 MEDICAL REVIEWER.—An independent medical 
39

•S 1945 IS 

1 reviewer shall, in accordance with the deadlines 

2 described in subsection (e), prepare a written 

3 determination to uphold, reverse, or modify the 

4 denial under review. Such written determination 

5 shall include—

6 (i) the determination of the reviewer; 

7 (ii) the specific reasons of the re8 viewer for such determination, including a 

9 summary of the clinical or scientific evi10 dence used in making the determination; 

11 and 

12 (iii) with respect to a determination to 

13 reverse or modify the denial under review, 

14 a timeframe within which the plan or 

15 issuer must comply with such determina16 tion. 

17 (G) NONBINDING NATURE OF ADDITIONAL

18 RECOMMENDATIONS.—In addition to the deter19 mination under subparagraph (F), the reviewer 

20 may provide the plan or issuer and the treating 

21 health care professional with additional rec22 ommendations in connection with such a deter23 mination, but any such recommendations shall 

24 not affect (or be treated as part of) the deter-
40

•S 1945 IS 

1 mination and shall not be binding on the plan 

2 or issuer. 

3 (e) TIMELINES AND NOTIFICATIONS.—

4 (1) TIMELINES FOR INDEPENDENT MEDICAL

5 REVIEW.—

6 (A) PRIOR AUTHORIZATION DETERMINA7 TION.—

8 (i) IN GENERAL.—The independent 

9 medical reviewer (or reviewers) shall make 

10 a determination on a denial of a claim for 

11 benefits that is referred to the reviewer 

12 under subsection (c)(3) in accordance with 

13 the medical exigencies of the case and as 

14 soon as possible, but in no case later than 

15 14 days after the date of receipt of infor16 mation under subsection (c)(2) if the re17 view involves a prior authorization of items 

18 or services and in no case later than 21 

19 days after the date the request for external 

20 review is received. 

21 (ii) EXPEDITED DETERMINATION.—

22 Notwithstanding clause (i) and subject to 

23 clause (iii), the independent medical re24 viewer (or reviewers) shall make an expe25 dited determination on a denial of a claim 
41

•S 1945 IS 

1 for benefits described in clause (i), when a 

2 request for such an expedited determina3 tion is made by a participant, beneficiary, 

4 or enrollee (or authorized representative) 

5 at any time during the process for making 

6 a determination, and a health care profes7 sional certifies, with the request, that a de8 termination under the timeline described in 

9 clause (i) would seriously jeopardize the 

10 life or health of the participant, bene11 ficiary, or enrollee or the ability of the par12 ticipant, beneficiary, or enrollee to main13 tain or regain maximum function. Such de14 termination shall be made as soon in ac15 cordance with the medical exigencies of the 

16 case and as soon as possible, but in no 

17 case later than 72 hours after the time the 

18 request for external review is received by 

19 the qualified external review entity. 

20 (iii) ONGOING CARE DETERMINA21 TION.—Notwithstanding clause (i), in the 

22 case of a review described in such sub23 clause that involves a termination or reduc24 tion of care, the notice of the determina25 tion shall be completed not later than 24 
42

•S 1945 IS 

1 hours after the time the request for exter2 nal review is received by the qualified ex3 ternal review entity and before the end of 

4 the approved period of care. 

5 (B) RETROSPECTIVE DETERMINATION.—

6 The independent medical reviewer (or review7 ers) shall complete a review in the case of a ret8 rospective determination on an appeal of a de9 nial of a claim for benefits that is referred to 

10 the reviewer under subsection (c)(3) in no case 

11 later than 30 days after the date of receipt of 

12 information under subsection (c)(2) and in no 

13 case later than 60 days after the date the re14 quest for external review is received by the 

15 qualified external review entity. 

16 (2) NOTIFICATION OF DETERMINATION.—The 

17 external review entity shall ensure that the plan or 

18 issuer, the participant, beneficiary, or enrollee (or 

19 authorized representative) and the treating health 

20 care professional (if any) receives a copy of the writ21 ten determination of the independent medical re22 viewer prepared under subsection (d)(3)(F). Nothing 

23 in this paragraph shall be construed as preventing 

24 an entity or reviewer from providing an initial oral 

25 notice of the reviewer’s determination. 
43

•S 1945 IS 

1 (3) FORM OF NOTICES.—Determinations and 

2 notices under this subsection shall be written in a 

3 manner calculated to be understood by a participant. 

4 (f) COMPLIANCE.—

5 (1) APPLICATION OF DETERMINATIONS.—

6 (A) EXTERNAL REVIEW DETERMINATIONS

7 BINDING ON PLAN.—The determinations of an 

8 external review entity and an independent med9 ical reviewer under this section shall be binding 

10 upon the plan or issuer involved. 

11 (B) COMPLIANCE WITH DETERMINA12 TION.—If the determination of an independent 

13 medical reviewer is to reverse or modify the de14 nial, the plan or issuer, upon the receipt of such 

15 determination, shall authorize coverage to com16 ply with the medical reviewer’s determination in 

17 accordance with the timeframe established by 

18 the medical reviewer. 

19 (2) FAILURE TO COMPLY.—

20 (A) IN GENERAL.—If a plan or issuer fails 

21 to comply with the timeframe established under 

22 paragraph (1)(B) with respect to a participant, 

23 beneficiary, or enrollee, where such failure to 

24 comply is caused by the plan or issuer, the par25 ticipant, beneficiary, or enrollee may obtain the
44

•S 1945 IS 

1 items or services involved (in a manner con2 sistent with the determination of the inde3 pendent external reviewer) from any provider 

4 regardless of whether such provider is a partici5 pating provider under the plan or coverage. 

6 (B) REIMBURSEMENT.—

7 (i) IN GENERAL.—Where a partici8 pant, beneficiary, or enrollee obtains items 

9 or services in accordance with subpara10 graph (A), the plan or issuer involved shall 

11 provide for reimbursement of the costs of 

12 such items or services. Such reimburse13 ment shall be made to the treating health 

14 care professional or to the participant, ben15 eficiary, or enrollee (in the case of a partic16 ipant, beneficiary, or enrollee who pays for 

17 the costs of such items or services). 

18 (ii) AMOUNT.—The plan or issuer 

19 shall fully reimburse a professional, partici20 pant, beneficiary, or enrollee under clause 

21 (i) for the total costs of the items or serv22 ices provided (regardless of any plan limi23 tations that may apply to the coverage of 

24 such items or services) so long as the items 

25 or services were provided in a manner con-
45

•S 1945 IS 

1 sistent with the determination of the inde2 pendent medical reviewer. 

3 (C) FAILURE TO REIMBURSE.—Where a 

4 plan or issuer fails to provide reimbursement to 

5 a professional, participant, beneficiary, or en6 rollee in accordance with this paragraph, the 

7 professional, participant, beneficiary, or enrollee 

8 may commence a civil action (or utilize other 

9 remedies available under law) to recover only 

10 the amount of any such reimbursement that is 

11 owed by the plan or issuer and any necessary 

12 legal costs or expenses (including attorney’s 

13 fees) incurred in recovering such reimburse14 ment. 

15 (D) AVAILABLE REMEDIES.—The remedies 

16 provided under this paragraph are in addition 

17 to any other available remedies. 

18 (3) PENALTIES AGAINST AUTHORIZED OFFI19 CIALS FOR REFUSING TO AUTHORIZE THE DETER20 MINATION OF AN EXTERNAL REVIEW ENTITY.—

21 (A) MONETARY PENALTIES.—

22 (i) IN GENERAL.—In any case in 

23 which the determination of an external re24 view entity is not followed by a group 

25 health plan, or by a health insurance issuer 
46

•S 1945 IS 

1 offering health insurance coverage, any 

2 person who, acting in the capacity of au3 thorizing the benefit, causes such refusal 

4 may, in the discretion in a court of com5 petent jurisdiction, be liable to an ag6 grieved participant, beneficiary, or enrollee 

7 for a civil penalty in an amount of up to 

8 $1,000 a day from the date on which the 

9 determination was transmitted to the plan 

10 or issuer by the external review entity until 

11 the date the refusal to provide the benefit 

12 is corrected. 

13 (ii) ADDITIONAL PENALTY FOR FAIL14 ING TO FOLLOW TIMELINE.—In any case 

15 in which treatment was not commenced by 

16 the plan in accordance with the determina17 tion of an independent external reviewer, 

18 the Secretary shall assess a civil penalty of 

19 $10,000 against the plan and the plan 

20 shall pay such penalty to the participant, 

21 beneficiary, or enrollee involved. 

22 (B) CEASE AND DESIST ORDER AND

23 ORDER OF ATTORNEY’S FEES.—In any action 

24 described in subparagraph (A) brought by a 

25 participant, beneficiary, or enrollee with respect 
47

•S 1945 IS 

1 to a group health plan, or a health insurance 

2 issuer offering health insurance coverage, in 

3 which a plaintiff alleges that a person referred 

4 to in such subparagraph has taken an action re5 sulting in a refusal of a benefit determined by 

6 an external appeal entity to be covered, or has 

7 failed to take an action for which such person 

8 is responsible under the terms and conditions of 

9 the plan or coverage and which is necessary 

10 under the plan or coverage for authorizing a 

11 benefit, the court shall cause to be served on 

12 the defendant an order requiring the defend13 ant—

14 (i) to cease and desist from the al15 leged action or failure to act; and 

16 (ii) to pay to the plaintiff a reasonable 

17 attorney’s fee and other reasonable costs 

18 relating to the prosecution of the action on 

19 the charges on which the plaintiff prevails. 

20 (C) ADDITIONAL CIVIL PENALTIES.—

21 (i) IN GENERAL.—In addition to any 

22 penalty imposed under subparagraph (A) 

23 or (B), the appropriate Secretary may as24 sess a civil penalty against a person acting 

25 in the capacity of authorizing a benefit de-
48

•S 1945 IS 

1 termined by an external review entity for 

2 one or more group health plans, or health 

3 insurance issuers offering health insurance 

4 coverage, for—

5 (I) any pattern or practice of re6 peated refusal to authorize a benefit 

7 determined by an external appeal enti8 ty to be covered; or 

9 (II) any pattern or practice of re10 peated violations of the requirements 

11 of this section with respect to such 

12 plan or coverage. 

13 (ii) STANDARD OF PROOF AND

14 AMOUNT OF PENALTY.—Such penalty shall 

15 be payable only upon proof by clear and 

16 convincing evidence of such pattern or 

17 practice and shall be in an amount not to 

18 exceed the lesser of—

19 (I) 25 percent of the aggregate 

20 value of benefits shown by the appro21 priate Secretary to have not been pro22 vided, or unlawfully delayed, in viola23 tion of this section under such pattern 

24 or practice; or 

25 (II) $500,000. 
49

•S 1945 IS 

1 (D) REMOVAL AND DISQUALIFICATION.—

2 Any person acting in the capacity of author3 izing benefits who has engaged in any such pat4 tern or practice described in subparagraph 

5 (C)(i) with respect to a plan or coverage, upon 

6 the petition of the appropriate Secretary, may 

7 be removed by the court from such position, 

8 and from any other involvement, with respect to 

9 such a plan or coverage, and may be precluded 

10 from returning to any such position or involve11 ment for a period determined by the court. 

12 (4) PROTECTION OF LEGAL RIGHTS.—Nothing 

13 in this subsection or subtitle shall be construed as 

14 altering or eliminating any cause of action or legal 

15 rights or remedies of participants, beneficiaries, en16 rollees, and others under State or Federal law (in17 cluding sections 502 and 503 of the Employee Re18 tirement Income Security Act of 1974), including 

19 the right to file judicial actions to enforce rights. 

20 (g) QUALIFICATIONS OF INDEPENDENT MEDICAL

21 REVIEWERS.—

22 (1) IN GENERAL.—In referring a denial to 1 or 

23 more individuals to conduct independent medical re24 view under subsection (c), the qualified external re25 view entity shall ensure that—
50

•S 1945 IS 

1 (A) each independent medical reviewer 

2 meets the qualifications described in paragraphs 

3 (2) and (3); 

4 (B) with respect to each review at least 1 

5 such reviewer meets the requirements described 

6 in paragraphs (4) and (5); and 

7 (C) compensation provided by the entity to 

8 the reviewer is consistent with paragraph (6). 

9 (2) LICENSURE AND EXPERTISE.—Each inde10 pendent medical reviewer shall be a physician 

11 (allopathic or osteopathic) or health care profes12 sional who—

13 (A) is appropriately credentialed or li14 censed in 1 or more States to deliver health 

15 care services; and 

16 (B) typically treats the condition, makes 

17 the diagnosis, or provides the type of treatment 

18 under review. 

19 (3) INDEPENDENCE.—

20 (A) IN GENERAL.—Subject to subpara21 graph (B), each independent medical reviewer 

22 in a case shall—

23 (i) not be a related party (as defined 

24 in paragraph (7)); 
51

•S 1945 IS 

1 (ii) not have a material familial, fi2 nancial, or professional relationship with 

3 such a party; and 

4 (iii) not otherwise have a conflict of 

5 interest with such a party (as determined 

6 under regulations). 

7 (B) EXCEPTION.—Nothing in subpara8 graph (A) shall be construed to—

9 (i) prohibit an individual, solely on the 

10 basis of affiliation with the plan or issuer, 

11 from serving as an independent medical re12 viewer if—

13 (I) a non-affiliated individual is 

14 not reasonably available; 

15 (II) the affiliated individual is 

16 not involved in the provision of items 

17 or services in the case under review; 

18 (III) the fact of such an affili19 ation is disclosed to the plan or issuer 

20 and the participant, beneficiary, or 

21 enrollee (or authorized representative) 

22 and neither party objects; and 

23 (IV) the affiliated individual is 

24 not an employee of the plan or issuer 

25 and does not provide services exclu-
52

•S 1945 IS 

1 sively or primarily to or on behalf of 

2 the plan or issuer; 

3 (ii) prohibit an individual who has 

4 staff privileges at the institution where the 

5 treatment involved takes place from serv6 ing as an independent medical reviewer 

7 merely on the basis of such affiliation if 

8 the affiliation is disclosed to the plan or 

9 issuer and the participant, beneficiary, or 

10 enrollee (or authorized representative), and 

11 neither party objects; or 

12 (iii) prohibit receipt of compensation 

13 by an independent medical reviewer from 

14 an entity if the compensation is provided 

15 consistent with paragraph (6). 

16 (4) PRACTICING HEALTH CARE PROFESSIONAL

17 IN SAME FIELD.—

18 (A) IN GENERAL.—In a case involving 

19 treatment, or the provision of items or serv20 ices—

21 (i) by a physician, a reviewer shall be 

22 a practicing physician (allopathic or osteo23 pathic) of the same or similar specialty, as 

24 a physician who, acting within the appro25 priate scope of practice within the State in 
53

•S 1945 IS 

1 which the service is provided or rendered, 

2 typically treats the condition, makes the 

3 diagnosis, or provides the type of treat4 ment under review; or 

5 (ii) by a non-physician health care 

6 professional, a reviewer (or reviewers) shall 

7 include at least one practicing non-physi8 cian health care professional of the same 

9 or similar specialty as the non-physician 

10 health care professional who, acting within 

11 the appropriate scope of practice within 

12 the State in which the service is provided 

13 or rendered, typically treats the condition, 

14 makes the diagnosis, or provides the type 

15 of treatment under review. 

16 (B) PRACTICING DEFINED.—For purposes 

17 of this paragraph, the term ‘‘practicing’’ means, 

18 with respect to an individual who is a physician 

19 or other health care professional that the indi20 vidual provides health care services to individual 

21 patients on average at least 2 days per week. 

22 (5) PEDIATRIC EXPERTISE.—In the case of an 

23 external review relating to a child, a reviewer shall 

24 have expertise under paragraph (2) in pediatrics. 
54

•S 1945 IS 

1 (6) LIMITATIONS ON REVIEWER COMPENSA2 TION.—Compensation provided by a qualified exter3 nal review entity to an independent medical reviewer 

4 in connection with a review under this section 

5 shall—

6 (A) not exceed a reasonable level; and 

7 (B) not be contingent on the decision ren8 dered by the reviewer. 

9 (7) RELATED PARTY DEFINED.—For purposes 

10 of this section, the term ‘‘related party’’ means, with 

11 respect to a denial of a claim under a plan or cov12 erage relating to a participant, beneficiary, or en13 rollee, any of the following: 

14 (A) The plan, plan sponsor, or issuer in15 volved, or any fiduciary, officer, director, or em16 ployee of such plan, plan sponsor, or issuer. 

17 (B) The participant, beneficiary, or en18 rollee (or authorized representative). 

19 (C) The health care professional that pro20 vides the items or services involved in the de21 nial. 

22 (D) The institution at which the items or 

23 services (or treatment) involved in the denial 

24 are provided. 
55

•S 1945 IS 

1 (E) The manufacturer of any drug or 

2 other item that is included in the items or serv3 ices involved in the denial. 

4 (F) Any other party determined under any 

5 regulations to have a substantial interest in the 

6 denial involved. 

7 (h) QUALIFIED EXTERNAL REVIEW ENTITIES.—

8 (1) SELECTION OF QUALIFIED EXTERNAL RE9 VIEW ENTITIES.—

10 (A) LIMITATION ON PLAN OR ISSUER SE11 LECTION.—The appropriate Secretary shall im12 plement procedures—

13 (i) to assure that the selection process 

14 among qualified external review entities 

15 will not create any incentives for external 

16 review entities to make a decision in a bi17 ased manner; and 

18 (ii) for auditing a sample of decisions 

19 by such entities to assure that no such de20 cisions are made in a biased manner. 

21 No such selection process under the procedures 

22 implemented by the appropriate Secretary may 

23 give either the patient or the plan or issuer any 

24 ability to determine or influence the selection of
56

•S 1945 IS 

1 a qualified external review entity to review the 

2 case of any participant, beneficiary, or enrollee. 

3 (B) STATE AUTHORITY WITH RESPECT TO

4 QUALIFIED EXTERNAL REVIEW ENTITIES FOR

5 HEALTH INSURANCE ISSUERS.—With respect to 

6 health insurance issuers offering health insur7 ance coverage in a State, the State may provide 

8 for external review activities to be conducted by 

9 a qualified external appeal entity that is des10 ignated by the State or that is selected by the 

11 State in a manner determined by the State to 

12 assure an unbiased determination. 

13 (2) CONTRACT WITH QUALIFIED EXTERNAL RE14 VIEW ENTITY.—Except as provided in paragraph 

15 (1)(B), the external review process of a plan or 

16 issuer under this section shall be conducted under a 

17 contract between the plan or issuer and 1 or more 

18 qualified external review entities (as defined in para19 graph (4)(A)). 

20 (3) TERMS AND CONDITIONS OF CONTRACT.—

21 The terms and conditions of a contract under para22 graph (2) shall—

23 (A) be consistent with the standards the 

24 appropriate Secretary shall establish to assure 
57

•S 1945 IS 

1 there is no real or apparent conflict of interest 

2 in the conduct of external review activities; and 

3 (B) provide that the costs of the external 

4 review process shall be borne by the plan or 

5 issuer. 

6 Subparagraph (B) shall not be construed as apply7 ing to the imposition of a filing fee under subsection 

8 (b)(2)(A)(iv) or costs incurred by the participant, 

9 beneficiary, or enrollee (or authorized representative) 

10 or treating health care professional (if any) in sup11 port of the review, including the provision of addi12 tional evidence or information. 

13 (4) QUALIFICATIONS.—

14 (A) IN GENERAL.—In this section, the 

15 term ‘‘qualified external review entity’’ means, 

16 in relation to a plan or issuer, an entity that is 

17 initially certified (and periodically recertified) 

18 under subparagraph (C) as meeting the fol19 lowing requirements: 

20 (i) The entity has (directly or through 

21 contracts or other arrangements) sufficient 

22 medical, legal, and other expertise and suf23 ficient staffing to carry out duties of a 

24 qualified external review entity under this 

25 section on a timely basis, including making 
58

•S 1945 IS 

1 determinations under subsection (b)(2)(A) 

2 and providing for independent medical re3 views under subsection (d). 

4 (ii) The entity is not a plan or issuer 

5 or an affiliate or a subsidiary of a plan or 

6 issuer, and is not an affiliate or subsidiary 

7 of a professional or trade association of 

8 plans or issuers or of health care providers. 

9 (iii) The entity has provided assur10 ances that it will conduct external review 

11 activities consistent with the applicable re12 quirements of this section and standards 

13 specified in subparagraph (C), including 

14 that it will not conduct any external review 

15 activities in a case unless the independence 

16 requirements of subparagraph (B) are met 

17 with respect to the case. 

18 (iv) The entity has provided assur19 ances that it will provide information in a 

20 timely manner under subparagraph (D). 

21 (v) The entity meets such other re22 quirements as the appropriate Secretary 

23 provides by regulation. 

24 (B) INDEPENDENCE REQUIREMENTS.—
59

•S 1945 IS 

1 (i) IN GENERAL.—Subject to clause 

2 (ii), an entity meets the independence re3 quirements of this subparagraph with re4 spect to any case if the entity—

5 (I) is not a related party (as de6 fined in subsection (g)(7)); 

7 (II) does not have a material fa8 milial, financial, or professional rela9 tionship with such a party; and 

10 (III) does not otherwise have a 

11 conflict of interest with such a party 

12 (as determined under regulations). 

13 (ii) EXCEPTION FOR REASONABLE

14 COMPENSATION.—Nothing in clause (i) 

15 shall be construed to prohibit receipt by a 

16 qualified external review entity of com17 pensation from a plan or issuer for the 

18 conduct of external review activities under 

19 this section if the compensation is provided 

20 consistent with clause (iii). 

21 (iii) LIMITATIONS ON ENTITY COM22 PENSATION.—Compensation provided by a 

23 plan or issuer to a qualified external review 

24 entity in connection with reviews under 

25 this section shall—
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•S 1945 IS 

1 (I) not exceed a reasonable level; 

2 and 

3 (II) not be contingent on any de4 cision rendered by the entity or by 

5 any independent medical reviewer. 

6 (C) CERTIFICATION AND RECERTIFICATION

7 PROCESS.—

8 (i) IN GENERAL.—The initial certifi9 cation and recertification of a qualified ex10 ternal review entity shall be made—

11 (I) under a process that is recog12 nized or approved by the appropriate 

13 Secretary; or 

14 (II) by a qualified private stand15 ard-setting organization that is ap16 proved by the appropriate Secretary 

17 under clause (iii). 

18 In taking action under subclause (I), the 

19 appropriate Secretary shall give deference 

20 to entities that are under contract with the 

21 Federal Government or with an applicable 

22 State authority to perform functions of the 

23 type performed by qualified external review 

24 entities. 
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•S 1945 IS 

1 (ii) PROCESS.—The appropriate Sec2 retary shall not recognize or approve a 

3 process under clause (i)(I) unless the proc4 ess applies standards (as promulgated in 

5 regulations) that ensure that a qualified 

6 external review entity—

7 (I) will carry out (and has car8 ried out, in the case of recertification) 

9 the responsibilities of such an entity 

10 in accordance with this section, in11 cluding meeting applicable deadlines; 

12 (II) will meet (and has met, in 

13 the case of recertification) appropriate 

14 indicators of fiscal integrity; 

15 (III) will maintain (and has 

16 maintained, in the case of recertifi17 cation) appropriate confidentiality 

18 with respect to individually identifi19 able health information obtained in 

20 the course of conducting external re21 view activities; and 

22 (IV) in the case recertification, 

23 shall review the matters described in 

24 clause (iv).
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•S 1945 IS 

1 (iii) APPROVAL OF QUALIFIED PRI2 VATE STANDARD-SETTING ORGANIZA3 TIONS.—For purposes of clause (i)(II), the 

4 appropriate Secretary may approve a quali5 fied private standard-setting organization 

6 if such Secretary finds that the organiza7 tion only certifies (or recertifies) external 

8 review entities that meet at least the 

9 standards required for the certification (or 

10 recertification) of external review entities 

11 under clause (ii). 

12 (iv) CONSIDERATIONS IN RECERTIFI13 CATIONS.—In conducting recertifications of 

14 a qualified external review entity under 

15 this paragraph, the appropriate Secretary 

16 or organization conducting the recertifi17 cation shall review compliance of the entity 

18 with the requirements for conducting ex19 ternal review activities under this section, 

20 including the following: 

21 (I) Provision of information 

22 under subparagraph (D). 

23 (II) Adherence to applicable 

24 deadlines (both by the entity and by 
63

•S 1945 IS 

1 independent medical reviewers it re2 fers cases to). 

3 (III) Compliance with limitations 

4 on compensation (with respect to both 

5 the entity and independent medical re6 viewers it refers cases to). 

7 (IV) Compliance with applicable 

8 independence requirements. 

9 (V) Compliance with the require10 ment of subsection (d)(1) that only 

11 medically reviewable decisions shall be 

12 the subject of independent medical re13 view and with the requirement of sub14 section (d)(3) that independent med15 ical reviewers may not require cov16 erage for specifically excluded bene17 fits. 

18 (v) PERIOD OF CERTIFICATION OR RE19 CERTIFICATION.—A certification or recer20 tification provided under this paragraph 

21 shall extend for a period not to exceed 2 

22 years. 

23 (vi) REVOCATION.—A certification or 

24 recertification under this paragraph may 

25 be revoked by the appropriate Secretary or 
64

•S 1945 IS 

1 by the organization providing such certifi2 cation upon a showing of cause. The Sec3 retary, or organization, shall revoke a cer4 tification or deny a recertification with re5 spect to an entity if there is a showing that 

6 the entity has a pattern or practice of or7 dering coverage for benefits that are spe8 cifically excluded under the plan or cov9 erage. 

10 (vii) PETITION FOR DENIAL OR WITH11 DRAWAL.—An individual may petition the 

12 Secretary, or an organization providing the 

13 certification involves, for a denial of recer14 tification or a withdrawal of a certification 

15 with respect to an entity under this sub16 paragraph if there is a pattern or practice 

17 of such entity failing to meet a require18 ment of this section. 

19 (viii) SUFFICIENT NUMBER OF ENTI20 TIES.—The appropriate Secretary shall 

21 certify and recertify a number of external 

22 review entities which is sufficient to ensure 

23 the timely and efficient provision of review 

24 services. 

25 (D) PROVISION OF INFORMATION.—
65

•S 1945 IS 

1 (i) IN GENERAL.—A qualified external 

2 review entity shall provide to the appro3 priate Secretary, in such manner and at 

4 such times as such Secretary may require, 

5 such information (relating to the denials 

6 which have been referred to the entity for 

7 the conduct of external review under this 

8 section) as such Secretary determines ap9 propriate to assure compliance with the 

10 independence and other requirements of 

11 this section to monitor and assess the qual12 ity of its external review activities and lack 

13 of bias in making determinations. Such in14 formation shall include information de15 scribed in clause (ii) but shall not include 

16 individually identifiable medical informa17 tion. 

18 (ii) INFORMATION TO BE IN19 CLUDED.—The information described in 

20 this subclause with respect to an entity is 

21 as follows: 

22 (I) The number and types of de23 nials for which a request for review 

24 has been received by the entity. 
66

•S 1945 IS 

1 (II) The disposition by the entity 

2 of such denials, including the number 

3 referred to a independent medical re4 viewer and the reasons for such dis5 positions (including the application of 

6 exclusions), on a plan or issuer-spe7 cific basis and on a health care spe8 cialty-specific basis. 

9 (III) The length of time in mak10 ing determinations with respect to 

11 such denials. 

12 (IV) Updated information on the 

13 information required to be submitted 

14 as a condition of certification with re15 spect to the entity’s performance of 

16 external review activities. 

17 (iii) INFORMATION TO BE PROVIDED

18 TO CERTIFYING ORGANIZATION.—

19 (I) IN GENERAL.—In the case of 

20 a qualified external review entity 

21 which is certified (or recertified) 

22 under this subsection by a qualified 

23 private standard-setting organization, 

24 at the request of the organization, the 

25 entity shall provide the organization 
67

•S 1945 IS 

1 with the information provided to the 

2 appropriate Secretary under clause 

3 (i). 

4 (II) ADDITIONAL INFORMA5 TION.—Nothing in this subparagraph 

6 shall be construed as preventing such 

7 an organization from requiring addi8 tional information as a condition of 

9 certification or recertification of an 

10 entity. 

11 (iv) USE OF INFORMATION.—Informa12 tion provided under this subparagraph may 

13 be used by the appropriate Secretary and 

14 qualified private standard-setting organiza15 tions to conduct oversight of qualified ex16 ternal review entities, including recertifi17 cation of such entities, and shall be made 

18 available to the public in an appropriate 

19 manner. 

20 (E) LIMITATION ON LIABILITY.—No quali21 fied external review entity having a contract 

22 with a plan or issuer, and no person who is em23 ployed by any such entity or who furnishes pro24 fessional services to such entity (including as an 

25 independent medical reviewer), shall be held by
68

•S 1945 IS 

1 reason of the performance of any duty, func2 tion, or activity required or authorized pursuant 

3 to this section, to be civilly liable under any law 

4 of the United States or of any State (or polit5 ical subdivision thereof) if there was no actual 

6 malice or gross misconduct in the performance 

7 of such duty, function, or activity. 

8 (5) REPORT.—Not later than 12 months after 

9 the general effective date referred to in section 501, 

10 the General Accounting Office shall prepare and 

11 submit to the appropriate committees of Congress a 

12 report concerning—

13 (A) the information that is provided under 

14 paragraph (3)(D); 

15 (B) the number of denials that have been 

16 upheld by independent medical reviewers and 

17 the number of denials that have been reversed 

18 by such reviewers; and 

19 (C) the extent to which independent med20 ical reviewers are requiring coverage for bene21 fits that are specifically excluded under the plan 

22 or coverage. 

23 SEC. 105. HEALTH CARE CONSUMER ASSISTANCE FUND. 

24 (a) GRANTS.—
69

•S 1945 IS 

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

2 Human Services (referred to in this section as the 

3 ‘‘Secretary’’) shall establish a fund, to be known as 

4 the ‘‘Health Care Consumer Assistance Fund’’, to be 

5 used to award grants to eligible States to carry out 

6 consumer assistance activities (including programs 

7 established by States prior to the enactment of this 

8 Act) designed to provide information, assistance, and 

9 referrals to consumers of health insurance products. 

10 (2) STATE ELIGIBILITY.—To be eligible to re11 ceive a grant under this subsection a State shall pre12 pare and submit to the Secretary an application at 

13 such time, in such manner, and containing such in14 formation as the Secretary may require, including a 

15 State plan that describes—

16 (A) the manner in which the State will en17 sure that the health care consumer assistance 

18 office (established under paragraph (4)) will 

19 educate and assist health care consumers in ac20 cessing needed care; 

21 (B) the manner in which the State will co22 ordinate and distinguish the services provided 

23 by the health care consumer assistance office 

24 with the services provided by Federal, State and 

25 local health-related ombudsman, information, 
70

•S 1945 IS 

1 protection and advocacy, insurance, and fraud 

2 and abuse programs; 

3 (C) the manner in which the State will 

4 provide information, outreach, and services to 

5 underserved, minority populations with limited 

6 English proficiency and populations residing in 

7 rural areas; 

8 (D) the manner in which the State will 

9 oversee the health care consumer assistance of10 fice, its activities, product materials and evalu11 ate program effectiveness; 

12 (E) the manner in which the State will en13 sure that funds made available under this sec14 tion will be used to supplement, and not sup15 plant, any other Federal, State, or local funds 

16 expended to provide services for programs de17 scribed under this section and those described 

18 in subparagraphs (C) and (D); 

19 (F) the manner in which the State will en20 sure that health care consumer office personnel 

21 have the professional background and training 

22 to carry out the activities of the office; and 

23 (G) the manner in which the State will en24 sure that consumers have direct access to con-
71

•S 1945 IS 

1 sumer assistance personnel during regular busi2 ness hours. 

3 (3) AMOUNT OF GRANT.—

4 (A) IN GENERAL.—From amounts appro5 priated under subsection (b) for a fiscal year, 

6 the Secretary shall award a grant to a State in 

7 an amount that bears the same ratio to such 

8 amounts as the number of individuals within 

9 the State covered under a group health plan or 

10 under health insurance coverage offered by a 

11 health insurance issuer bears to the total num12 ber of individuals so covered in all States (as 

13 determined by the Secretary). Any amounts 

14 provided to a State under this subsection that 

15 are not used by the State shall be remitted to 

16 the Secretary and reallocated in accordance 

17 with this subparagraph. 

18 (B) MINIMUM AMOUNT.—In no case shall 

19 the amount provided to a State under a grant 

20 under this subsection for a fiscal year be less 

21 than an amount equal to 0.5 percent of the 

22 amount appropriated for such fiscal year to 

23 carry out this section. 

24 (C) NON-FEDERAL CONTRIBUTIONS.—A 

25 State will provide for the collection of non-Fed-
72

•S 1945 IS 

1 eral contributions for the operation of the office 

2 in an amount that is not less than 25 percent 

3 of the amount of Federal funds provided to the 

4 State under this section. 

5 (4) PROVISION OF FUNDS FOR ESTABLISHMENT

6 OF OFFICE.—

7 (A) IN GENERAL.—From amounts pro8 vided under a grant under this subsection, a 

9 State shall, directly or through a contract with 

10 an independent, nonprofit entity with dem11 onstrated experience in serving the needs of 

12 health care consumers, provide for the estab13 lishment and operation of a State health care 

14 consumer assistance office. 

15 (B) ELIGIBILITY OF ENTITY.—To be eligi16 ble to enter into a contract under subparagraph 

17 (A), an entity shall demonstrate that it has the 

18 technical, organizational, and professional ca19 pacity to deliver the services described in sub20 section (b) to all public and private health in21 surance participants, beneficiaries, enrollees, or 

22 prospective enrollees. 

23 (C) EXISTING STATE ENTITY.—Nothing in 

24 this section shall prevent the funding of an ex25 isting health care consumer assistance program
73

•S 1945 IS 

1 that otherwise meets the requirements of this 

2 section. 

3 (b) USE OF FUNDS.—

4 (1) BY STATE.—A State shall use amounts pro5 vided under a grant awarded under this section to 

6 carry out consumer assistance activities directly or 

7 by contract with an independent, non-profit organi8 zation. An eligible entity may use some reasonable 

9 amount of such grant to ensure the adequate train10 ing of personnel carrying out such activities. To re11 ceive amounts under this subsection, an eligible enti12 ty shall provide consumer assistance services, includ13 ing—

14 (A) the operation of a toll-free telephone 

15 hotline to respond to consumer requests; 

16 (B) the dissemination of appropriate edu17 cational materials on available health insurance 

18 products and on how best to access health care 

19 and the rights and responsibilities of health 

20 care consumers; 

21 (C) the provision of education on effective 

22 methods to promptly and efficiently resolve 

23 questions, problems, and grievances; 
74

•S 1945 IS 

1 (D) the coordination of educational and 

2 outreach efforts with health plans, health care 

3 providers, payers, and governmental agencies; 

4 (E) referrals to appropriate private and 

5 public entities to resolve questions, problems 

6 and grievances; and 

7 (F) the provision of information and as8 sistance, including acting as an authorized rep9 resentative, regarding internal, external, or ad10 ministrative grievances or appeals procedures in 

11 nonlitigative settings to appeal the denial, ter12 mination, or reduction of health care services, 

13 or the refusal to pay for such services, under a 

14 group health plan or health insurance coverage 

15 offered by a health insurance issuer. 

16 (2) CONFIDENTIALITY AND ACCESS TO INFOR17 MATION.—

18 (A) STATE ENTITY.—With respect to a 

19 State that directly establishes a health care con20 sumer assistance office, such office shall estab21 lish and implement procedures and protocols in 

22 accordance with applicable Federal and State 

23 laws. 

24 (B) CONTRACT ENTITY.—With respect to a 

25 State that, through contract, establishes a 
75

•S 1945 IS 

1 health care consumer assistance office, such of2 fice shall establish and implement procedures 

3 and protocols, consistent with applicable Fed4 eral and State laws, to ensure the confiden5 tiality of all information shared by a partici6 pant, beneficiary, enrollee, or their personal 

7 representative and their health care providers, 

8 group health plans, or health insurance insurers 

9 with the office and to ensure that no such infor10 mation is used by the office, or released or dis11 closed to State agencies or outside persons or 

12 entities without the prior written authorization 

13 (in accordance with section 164.508 of title 45, 

14 Code of Federal Regulations) of the individual 

15 or personal representative. The office may, con16 sistent with applicable Federal and State con17 fidentiality laws, collect, use or disclose aggre18 gate information that is not individually identi19 fiable (as defined in section 164.501 of title 45, 

20 Code of Federal Regulations). The office shall 

21 provide a written description of the policies and 

22 procedures of the office with respect to the 

23 manner in which health information may be 

24 used or disclosed to carry out consumer assist25 ance activities. The office shall provide health 
76

•S 1945 IS 

1 care providers, group health plans, or health in2 surance issuers with a written authorization (in 

3 accordance with section 164.508 of title 45, 

4 Code of Federal Regulations) to allow the office 

5 to obtain medical information relevant to the 

6 matter before the office. 

7 (3) AVAILABILITY OF SERVICES.—The health 

8 care consumer assistance office of a State shall not 

9 discriminate in the provision of information, refer10 rals, and services regardless of the source of the in11 dividual’s health insurance coverage or prospective 

12 coverage, including individuals covered under a 

13 group health plan or health insurance coverage of14 fered by a health insurance issuer, the medicare or 

15 medicaid programs under title XVIII or XIX of the 

16 Social Security Act (42 U.S.C. 1395 and 1396 et 

17 seq.), or under any other Federal or State health 

18 care program. 

19 (4) DESIGNATION OF RESPONSIBILITIES.—

20 (A) WITHIN EXISTING STATE ENTITY.—If 

21 the health care consumer assistance office of a 

22 State is located within an existing State regu23 latory agency or office of an elected State offi24 cial, the State shall ensure that—
77

•S 1945 IS 

1 (i) there is a separate delineation of 

2 the funding, activities, and responsibilities 

3 of the office as compared to the other 

4 funding, activities, and responsibilities of 

5 the agency; and 

6 (ii) the office establishes and imple7 ments procedures and protocols to ensure 

8 the confidentiality of all information 

9 shared by a participant, beneficiary, or en10 rollee or their personal representative and 

11 their health care providers, group health 

12 plans, or health insurance issuers with the 

13 office and to ensure that no information is 

14 disclosed to the State agency or office 

15 without the written authorization of the in16 dividual or their personal representative in 

17 accordance with paragraph (2). 

18 (B) CONTRACT ENTITY.—In the case of an 

19 entity that enters into a contract with a State 

20 under subsection (a)(3), the entity shall provide 

21 assurances that the entity has no conflict of in22 terest in carrying out the activities of the office 

23 and that the entity is independent of group 

24 health plans, health insurance issuers, pro25 viders, payers, and regulators of health care.
78

•S 1945 IS 

1 (5) SUBCONTRACTS.—The health care con2 sumer assistance office of a State may carry out ac3 tivities and provide services through contracts en4 tered into with 1 or more nonprofit entities so long 

5 as the office can demonstrate that all of the require6 ments of this section are complied with by the office. 

7 (6) TERM.—A contract entered into under this 

8 subsection shall be for a term of 3 years. 

9 (c) REPORT.—Not later than 1 year after the Sec10 retary first awards grants under this section, and annually 

11 thereafter, the Secretary shall prepare and submit to the 

12 appropriate committees of Congress a report concerning 

13 the activities funded under this section and the effective14 ness of such activities in resolving health care-related 

15 problems and grievances. 

16 (d) AUTHORIZATION OF APPROPRIATIONS.—There 

17 are authorized to be appropriated such sums as may be 

18 necessary to carry out this section. 

19 Subtitle B—Access to Care 

20 SEC. 111. CONSUMER CHOICE OPTION. 

21 (a) IN GENERAL.—If—

22 (1) a health insurance issuer providing health 

23 insurance coverage in connection with a group health 

24 plan offers to enrollees health insurance coverage 

25 which provides for coverage of services only if such 
79

•S 1945 IS 

1 services are furnished through health care profes2 sionals and providers who are members of a network 

3 of health care professionals and providers who have 

4 entered into a contract with the issuer to provide 

5 such services, or 

6 (2) a group health plan offers to participants or 

7 beneficiaries health benefits which provide for cov8 erage of services only if such services are furnished 

9 through health care professionals and providers who 

10 are members of a network of health care profes11 sionals and providers who have entered into a con12 tract with the plan to provide such services, 

13 then the issuer or plan shall also offer or arrange to be 

14 offered to such enrollees, participants, or beneficiaries (at 

15 the time of enrollment and during an annual open season 

16 as provided under subsection (c)) the option of health in17 surance coverage or health benefits which provide for cov18 erage of such services which are not furnished through 

19 health care professionals and providers who are members 

20 of such a network unless such enrollees, participants, or 

21 beneficiaries are offered such non-network coverage 

22 through another group health plan or through another 

23 health insurance issuer in the group market. 

24 (b) ADDITIONAL COSTS.—The amount of any addi25 tional premium charged by the health insurance issuer or 
80

•S 1945 IS 

1 group health plan for the additional cost of the creation 

2 and maintenance of the option described in subsection (a) 

3 and the amount of any additional cost sharing imposed 

4 under such option shall be borne by the enrollee, partici5 pant, or beneficiary unless it is paid by the health plan 

6 sponsor or group health plan through agreement with the 

7 health insurance issuer. 

8 (c) OPEN SEASON.—An enrollee, participant, or ben9 eficiary, may change to the offering provided under this 

10 section only during a time period determined by the health 

11 insurance issuer or group health plan. Such time period 

12 shall occur at least annually. 

13 SEC. 112. CHOICE OF HEALTH CARE PROFESSIONAL. 

14 (a) PRIMARY CARE.—If a group health plan, or a 

15 health insurance issuer that offers health insurance cov16 erage, requires or provides for designation by a partici17 pant, beneficiary, or enrollee of a participating primary 

18 care provider, then the plan or issuer shall permit each 

19 participant, beneficiary, and enrollee to designate any par20 ticipating primary care provider who is available to accept 

21 such individual. 

22 (b) SPECIALISTS.—

23 (1) IN GENERAL.—Subject to paragraph (2), a 

24 group health plan and a health insurance issuer that 

25 offers health insurance coverage shall permit each 
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•S 1945 IS 

1 participant, beneficiary, or enrollee to receive medi2 cally necessary and appropriate specialty care, pur3 suant to appropriate referral procedures, from any 

4 qualified participating health care professional who 

5 is available to accept such individual for such care. 

6 (2) LIMITATION.—Paragraph (1) shall not 

7 apply to specialty care if the plan or issuer clearly 

8 informs participants, beneficiaries, and enrollees of 

9 the limitations on choice of participating health care 

10 professionals with respect to such care. 

11 (3) CONSTRUCTION.—Nothing in this sub12 section shall be construed as affecting the applica13 tion of section 114 (relating to access to specialty 

14 care). 

15 SEC. 113. ACCESS TO EMERGENCY CARE. 

16 (a) COVERAGE OF EMERGENCY SERVICES.—

17 (1) IN GENERAL.—If a group health plan, or 

18 health insurance coverage offered by a health insur19 ance issuer, provides or covers any benefits with re20 spect to services in an emergency department of a 

21 hospital, the plan or issuer shall cover emergency 

22 services (as defined in paragraph (2)(B))—

23 (A) without the need for any prior author24 ization determination; 
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•S 1945 IS 

1 (B) whether the health care provider fur2 nishing such services is a participating provider 

3 with respect to such services; 

4 (C) in a manner so that, if such services 

5 are provided to a participant, beneficiary, or en6 rollee—

7 (i) by a nonparticipating health care 

8 provider with or without prior authoriza9 tion, or 

10 (ii) by a participating health care pro11 vider without prior authorization, 

12 the participant, beneficiary, or enrollee is not 

13 liable for amounts that exceed the amounts of 

14 liability that would be incurred if the services 

15 were provided by a participating health care 

16 provider with prior authorization; and 

17 (D) without regard to any other term or 

18 condition of such coverage (other than exclusion 

19 or coordination of benefits, or an affiliation or 

20 waiting period, permitted under section 2701 of 

21 the Public Health Service Act, section 701 of 

22 the Employee Retirement Income Security Act 

23 of 1974, or section 9801 of the Internal Rev24 enue Code of 1986, and other than applicable 

25 cost-sharing).
83

•S 1945 IS 

1 (2) DEFINITIONS.—In this section: 

2 (A) EMERGENCY MEDICAL CONDITION.—

3 The term ‘‘emergency medical condition’’ means 

4 a medical condition manifesting itself by acute 

5 symptoms of sufficient severity (including se6 vere pain) such that a prudent layperson, who 

7 possesses an average knowledge of health and 

8 medicine, could reasonably expect the absence 

9 of immediate medical attention to result in a 

10 condition described in clause (i), (ii), or (iii) of 

11 section 1867(e)(1)(A) of the Social Security 

12 Act. 

13 (B) EMERGENCY SERVICES.—The term 

14 ‘‘emergency services’’ means, with respect to an 

15 emergency medical condition—

16 (i) a medical screening examination 

17 (as required under section 1867 of the So18 cial Security Act) that is within the capa19 bility of the emergency department of a 

20 hospital, including ancillary services rou21 tinely available to the emergency depart22 ment to evaluate such emergency medical 

23 condition, and 

24 (ii) within the capabilities of the staff 

25 and facilities available at the hospital, such 
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•S 1945 IS 

1 further medical examination and treatment 

2 as are required under section 1867 of such 

3 Act to stabilize the patient. 

4 (C) STABILIZE.—The term ‘‘to stabilize’’, 

5 with respect to an emergency medical condition 

6 (as defined in subparagraph (A)), has the 

7 meaning given in section 1867(e)(3) of the So8 cial Security Act (42 U.S.C. 1395dd(e)(3)). 

9 (b) REIMBURSEMENT FOR MAINTENANCE CARE AND

10 POST-STABILIZATION CARE.—A group health plan, and 

11 health insurance coverage offered by a health insurance 

12 issuer, must provide reimbursement for maintenance care 

13 and post-stabilization care in accordance with the require14 ments of section 1852(d)(2) of the Social Security Act (42 

15 U.S.C. 1395w–22(d)(2)). Such reimbursement shall be 

16 provided in a manner consistent with subsection (a)(1)(C). 

17 (c) COVERAGE OF EMERGENCY AMBULANCE SERV18 ICES.—

19 (1) IN GENERAL.—If a group health plan, or 

20 health insurance coverage provided by a health in21 surance issuer, provides any benefits with respect to 

22 ambulance services and emergency services, the plan 

23 or issuer shall cover emergency ambulance services 

24 (as defined in paragraph (2)) furnished under the 

25 plan or coverage under the same terms and condi-
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•S 1945 IS 

1 tions under subparagraphs (A) through (D) of sub2 section (a)(1) under which coverage is provided for 

3 emergency services. 

4 (2) EMERGENCY AMBULANCE SERVICES.—For 

5 purposes of this subsection, the term ‘‘emergency 

6 ambulance services’’ means ambulance services (as 

7 defined for purposes of section 1861(s)(7) of the So8 cial Security Act) furnished to transport an indi9 vidual who has an emergency medical condition (as 

10 defined in subsection (a)(2)(A)) to a hospital for the 

11 receipt of emergency services (as defined in sub12 section (a)(2)(B)) in a case in which the emergency 

13 services are covered under the plan or coverage pur14 suant to subsection (a)(1) and a prudent layperson, 

15 with an average knowledge of health and medicine, 

16 could reasonably expect that the absence of such 

17 transport would result in placing the health of the 

18 individual in serious jeopardy, serious impairment of 

19 bodily function, or serious dysfunction of any bodily 

20 organ or part. 

21 SEC. 114. TIMELY ACCESS TO SPECIALISTS. 

22 (a) TIMELY ACCESS.—

23 (1) IN GENERAL.—A group health plan or 

24 health insurance issuer offering health insurance 

25 coverage shall ensure that participants, beneficiaries, 
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•S 1945 IS 

1 and enrollees receive timely access to specialists who 

2 are appropriate to the condition of, and accessible 

3 to, the participant, beneficiary, or enrollee, when 

4 such specialty care is a covered benefit under the 

5 plan or coverage. 

6 (2) RULE OF CONSTRUCTION.—Nothing in 

7 paragraph (1) shall be construed—

8 (A) to require the coverage under a group 

9 health plan or health insurance coverage of ben10 efits or services; 

11 (B) to prohibit a plan or issuer from in12 cluding providers in the network only to the ex13 tent necessary to meet the needs of the plan’s 

14 or issuer’s participants, beneficiaries, or enroll15 ees; or 

16 (C) to override any State licensure or 

17 scope-of-practice law. 

18 (3) ACCESS TO CERTAIN PROVIDERS.—

19 (A) IN GENERAL.—With respect to spe20 cialty care under this section, if a participating 

21 specialist is not available and qualified to pro22 vide such care to the participant, beneficiary, or 

23 enrollee, the plan or issuer shall provide for cov24 erage of such care by a nonparticipating spe25 cialist. 
87

•S 1945 IS 

1 (B) TREATMENT OF NONPARTICIPATING

2 PROVIDERS.—If a participant, beneficiary, or 

3 enrollee receives care from a nonparticipating 

4 specialist pursuant to subparagraph (A), such 

5 specialty care shall be provided at no additional 

6 cost to the participant, beneficiary, or enrollee 

7 beyond what the participant, beneficiary, or en8 rollee would otherwise pay for such specialty 

9 care if provided by a participating specialist. 

10 (b) REFERRALS.—

11 (1) AUTHORIZATION.—Subject to subsection 

12 (a)(1), a group health plan or health insurance 

13 issuer may require an authorization in order to ob14 tain coverage for specialty services under this sec15 tion. Any such authorization—

16 (A) shall be for an appropriate duration of 

17 time or number of referrals, including an au18 thorization for a standing referral where appro19 priate; and 

20 (B) may not be refused solely because the 

21 authorization involves services of a nonpartici22 pating specialist (described in subsection 

23 (a)(3)). 

24 (2) REFERRALS FOR ONGOING SPECIAL CONDI25 TIONS.—
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•S 1945 IS 

1 (A) IN GENERAL.—Subject to subsection 

2 (a)(1), a group health plan or health insurance 

3 issuer shall permit a participant, beneficiary, or 

4 enrollee who has an ongoing special condition 

5 (as defined in subparagraph (B)) to receive a 

6 referral to a specialist for the treatment of such 

7 condition and such specialist may authorize 

8 such referrals, procedures, tests, and other 

9 medical services with respect to such condition, 

10 or coordinate the care for such condition, sub11 ject to the terms of a treatment plan (if any) 

12 referred to in subsection (c) with respect to the 

13 condition. 

14 (B) ONGOING SPECIAL CONDITION DE15 FINED.—In this subsection, the term ‘‘ongoing 

16 special condition’’ means a condition or disease 

17 that—

18 (i) is life-threatening, degenerative, 

19 potentially disabling, or congenital; and 

20 (ii) requires specialized medical care 

21 over a prolonged period of time. 

22 (c) TREATMENT PLANS.—

23 (1) IN GENERAL.—A group health plan or 

24 health insurance issuer may require that the spe25 cialty care be provided—
89

•S 1945 IS 

1 (A) pursuant to a treatment plan, but only 

2 if the treatment plan—

3 (i) is developed by the specialist, in 

4 consultation with the case manager or pri5 mary care provider, and the participant, 

6 beneficiary, or enrollee, and 

7 (ii) is approved by the plan or issuer 

8 in a timely manner, if the plan or issuer 

9 requires such approval; and 

10 (B) in accordance with applicable quality 

11 assurance and utilization review standards of 

12 the plan or issuer. 

13 (2) NOTIFICATION.—Nothing in paragraph (1) 

14 shall be construed as prohibiting a plan or issuer 

15 from requiring the specialist to provide the plan or 

16 issuer with regular updates on the specialty care 

17 provided, as well as all other reasonably necessary 

18 medical information. 

19 (d) SPECIALIST DEFINED.—For purposes of this sec20 tion, the term ‘‘specialist’’ means, with respect to the con21 dition of the participant, beneficiary, or enrollee, a health 

22 care professional, facility, or center that has adequate ex23 pertise through appropriate training and experience (in24 cluding, in the case of a child, appropriate pediatric exper25 tise) to provide high quality care in treating the condition. 
90

•S 1945 IS 

1 SEC. 115. PATIENT ACCESS TO OBSTETRICAL AND GYNECO2 LOGICAL CARE. 

3 (a) GENERAL RIGHTS.—

4 (1) DIRECT ACCESS.—A group health plan, or 

5 health insurance issuer offering health insurance 

6 coverage, described in subsection (b) may not re7 quire authorization or referral by the plan, issuer, or 

8 any person (including a primary care provider de9 scribed in subsection (b)(2)) in the case of a female 

10 participant, beneficiary, or enrollee who seeks cov11 erage for obstetrical or gynecological care provided 

12 by a participating health care professional who spe13 cializes in obstetrics or gynecology. 

14 (2) OBSTETRICAL AND GYNECOLOGICAL

15 CARE.—A group health plan or health insurance 

16 issuer described in subsection (b) shall treat the pro17 vision of obstetrical and gynecological care, and the 

18 ordering of related obstetrical and gynecological 

19 items and services, pursuant to the direct access de20 scribed under paragraph (1), by a participating 

21 health care professional who specializes in obstetrics 

22 or gynecology as the authorization of the primary 

23 care provider. 

24 (b) APPLICATION OF SECTION.—A group health plan, 

25 or health insurance issuer offering health insurance cov-
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•S 1945 IS 

1 erage, described in this subsection is a group health plan 

2 or coverage that—

3 (1) provides coverage for obstetric or 

4 gynecologic care; and 

5 (2) requires the designation by a participant, 

6 beneficiary, or enrollee of a participating primary 

7 care provider. 

8 (c) CONSTRUCTION.—Nothing in subsection (a) shall 

9 be construed to—

10 (1) waive any exclusions of coverage under the 

11 terms and conditions of the plan or health insurance 

12 coverage with respect to coverage of obstetrical or 

13 gynecological care; or 

14 (2) preclude the group health plan or health in15 surance issuer involved from requiring that the ob16 stetrical or gynecological provider notify the primary 

17 care health care professional or the plan or issuer of 

18 treatment decisions. 

19 SEC. 116. ACCESS TO PEDIATRIC CARE. 

20 (a) PEDIATRIC CARE.—In the case of a person who 

21 has a child who is a participant, beneficiary, or enrollee 

22 under a group health plan, or health insurance coverage 

23 offered by a health insurance issuer, if the plan or issuer 

24 requires or provides for the designation of a participating 

25 primary care provider for the child, the plan or issuer shall 
92

•S 1945 IS 

1 permit such person to designate a physician (allopathic or 

2 osteopathic) who specializes in pediatrics as the child’s pri3 mary care provider if such provider participates in the net4 work of the plan or issuer. 

5 (b) CONSTRUCTION.—Nothing in subsection (a) shall 

6 be construed to waive any exclusions of coverage under 

7 the terms and conditions of the plan or health insurance 

8 coverage with respect to coverage of pediatric care. 

9 SEC. 117. CONTINUITY OF CARE. 

10 (a) TERMINATION OF PROVIDER.—

11 (1) IN GENERAL.—If—

12 (A) a contract between a group health 

13 plan, or a health insurance issuer offering 

14 health insurance coverage, and a treating health 

15 care provider is terminated (as defined in para16 graph (e)(4)), or 

17 (B) benefits or coverage provided by a 

18 health care provider are terminated because of 

19 a change in the terms of provider participation 

20 in such plan or coverage, 

21 the plan or issuer shall meet the requirements of 

22 paragraph (3) with respect to each continuing care 

23 patient. 

24 (2) TREATMENT OF TERMINATION OF CON25 TRACT WITH HEALTH INSURANCE ISSUER.—If a
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•S 1945 IS 

1 contract for the provision of health insurance cov2 erage between a group health plan and a health in3 surance issuer is terminated and, as a result of such 

4 termination, coverage of services of a health care 

5 provider is terminated with respect to an individual, 

6 the provisions of paragraph (1) (and the succeeding 

7 provisions of this section) shall apply under the plan 

8 in the same manner as if there had been a contract 

9 between the plan and the provider that had been ter10 minated, but only with respect to benefits that are 

11 covered under the plan after the contract termi12 nation. 

13 (3) REQUIREMENTS.—The requirements of this 

14 paragraph are that the plan or issuer—

15 (A) notify the continuing care patient in16 volved, or arrange to have the patient notified 

17 pursuant to subsection (d)(2), on a timely basis 

18 of the termination described in paragraph (1) 

19 (or paragraph (2), if applicable) and the right 

20 to elect continued transitional care from the 

21 provider under this section; 

22 (B) provide the patient with an oppor23 tunity to notify the plan or issuer of the pa24 tient’s need for transitional care; and 
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•S 1945 IS 

1 (C) subject to subsection (c), permit the 

2 patient to elect to continue to be covered with 

3 respect to the course of treatment by such pro4 vider with the provider’s consent during a tran5 sitional period (as provided for under subsection 

6 (b)). 

7 (4) CONTINUING CARE PATIENT.—For purposes 

8 of this section, the term ‘‘continuing care patient’’ 

9 means a participant, beneficiary, or enrollee who—

10 (A) is undergoing a course of treatment 

11 for a serious and complex condition from the 

12 provider at the time the plan or issuer receives 

13 or provides notice of provider, benefit, or cov14 erage termination described in paragraph (1) 

15 (or paragraph (2), if applicable); 

16 (B) is undergoing a course of institutional 

17 or inpatient care from the provider at the time 

18 of such notice; 

19 (C) is scheduled to undergo non-elective 

20 surgery from the provider at the time of such 

21 notice; 

22 (D) is pregnant and undergoing a course 

23 of treatment for the pregnancy from the pro24 vider at the time of such notice; or 
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•S 1945 IS 

1 (E) is or was determined to be terminally 

2 ill (as determined under section 1861(dd)(3)(A) 

3 of the Social Security Act) at the time of such 

4 notice, but only with respect to a provider that 

5 was treating the terminal illness before the date 

6 of such notice. 

7 (b) TRANSITIONAL PERIODS.—

8 (1) SERIOUS AND COMPLEX CONDITIONS.—The 

9 transitional period under this subsection with re10 spect to a continuing care patient described in sub11 section (a)(4)(A) shall extend for up to 90 days (as 

12 determined by the treating health care professional) 

13 from the date of the notice described in subsection 

14 (a)(3)(A). 

15 (2) INSTITUTIONAL OR INPATIENT CARE.—The 

16 transitional period under this subsection for a con17 tinuing care patient described in subsection 

18 (a)(4)(B) shall extend until the earlier of—

19 (A) the expiration of the 90-day period be20 ginning on the date on which the notice under 

21 subsection (a)(3)(A) is provided; or 

22 (B) the date of discharge of the patient 

23 from such care or the termination of the period 

24 of institutionalization, or, if later, the date of 

25 completion of reasonable follow-up care. 
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•S 1945 IS 

1 (3) SCHEDULED NON-ELECTIVE SURGERY.—

2 The transitional period under this subsection for a 

3 continuing care patient described in subsection 

4 (a)(4)(C) shall extend until the completion of the 

5 surgery involved and post-surgical follow-up care re6 lating to the surgery and occurring within 90 days 

7 after the date of the surgery. 

8 (4) PREGNANCY.—The transitional period 

9 under this subsection for a continuing care patient 

10 described in subsection (a)(4)(D) shall extend 

11 through the provision of post-partum care directly 

12 related to the delivery. 

13 (5) TERMINAL ILLNESS.—The transitional pe14 riod under this subsection for a continuing care pa15 tient described in subsection (a)(4)(E) shall extend 

16 for the remainder of the patient’s life for care that 

17 is directly related to the treatment of the terminal 

18 illness or its medical manifestations. 

19 (c) PERMISSIBLE TERMS AND CONDITIONS.—A 

20 group health plan or health insurance issuer may condi21 tion coverage of continued treatment by a provider under 

22 this section upon the provider agreeing to the following 

23 terms and conditions: 

24 (1) The treating health care provider agrees to 

25 accept reimbursement from the plan or issuer and 
97

•S 1945 IS 

1 continuing care patient involved (with respect to 

2 cost-sharing) at the rates applicable prior to the 

3 start of the transitional period as payment in full 

4 (or, in the case described in subsection (a)(2), at the 

5 rates applicable under the replacement plan or cov6 erage after the date of the termination of the con7 tract with the group health plan or health insurance 

8 issuer) and not to impose cost-sharing with respect 

9 to the patient in an amount that would exceed the 

10 cost-sharing that could have been imposed if the 

11 contract referred to in subsection (a)(1) had not 

12 been terminated. 

13 (2) The treating health care provider agrees to 

14 adhere to the quality assurance standards of the 

15 plan or issuer responsible for payment under para16 graph (1) and to provide to such plan or issuer nec17 essary medical information related to the care pro18 vided. 

19 (3) The treating health care provider agrees 

20 otherwise to adhere to such plan’s or issuer’s policies 

21 and procedures, including procedures regarding re22 ferrals and obtaining prior authorization and pro23 viding services pursuant to a treatment plan (if any) 

24 approved by the plan or issuer.
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•S 1945 IS 

1 (d) RULES OF CONSTRUCTION.—Nothing in this sec2 tion shall be construed—

3 (1) to require the coverage of benefits which 

4 would not have been covered if the provider involved 

5 remained a participating provider; or 

6 (2) with respect to the termination of a con7 tract under subsection (a) to prevent a group health 

8 plan or health insurance issuer from requiring that 

9 the health care provider—

10 (A) notify participants, beneficiaries, or en11 rollees of their rights under this section; or 

12 (B) provide the plan or issuer with the 

13 name of each participant, beneficiary, or en14 rollee who the provider believes is a continuing 

15 care patient. 

16 (e) DEFINITIONS.—In this section: 

17 (1) CONTRACT.—The term ‘‘contract’’ includes, 

18 with respect to a plan or issuer and a treating 

19 health care provider, a contract between such plan 

20 or issuer and an organized network of providers that 

21 includes the treating health care provider, and (in 

22 the case of such a contract) the contract between the 

23 treating health care provider and the organized net24 work. 
99

•S 1945 IS 

1 (2) HEALTH CARE PROVIDER.—The term 

2 ‘‘health care provider’’ or ‘‘provider’’ means—

3 (A) any individual who is engaged in the 

4 delivery of health care services in a State and 

5 who is required by State law or regulation to be 

6 licensed or certified by the State to engage in 

7 the delivery of such services in the State; and 

8 (B) any entity that is engaged in the deliv9 ery of health care services in a State and that, 

10 if it is required by State law or regulation to be 

11 licensed or certified by the State to engage in 

12 the delivery of such services in the State, is so 

13 licensed. 

14 (3) SERIOUS AND COMPLEX CONDITION.—The 

15 term ‘‘serious and complex condition’’ means, with 

16 respect to a participant, beneficiary, or enrollee 

17 under the plan or coverage—

18 (A) in the case of an acute illness, a condi19 tion that is serious enough to require special20 ized medical treatment to avoid the reasonable 

21 possibility of death or permanent harm; or 

22 (B) in the case of a chronic illness or con23 dition, is an ongoing special condition (as de24 fined in section 114(b)(2)(B)). 
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•S 1945 IS 

1 (4) TERMINATED.—The term ‘‘terminated’’ in2 cludes, with respect to a contract, the expiration or 

3 nonrenewal of the contract, but does not include a 

4 termination of the contract for failure to meet appli5 cable quality standards or for fraud. 

6 SEC. 118. ACCESS TO NEEDED PRESCRIPTION DRUGS. 

7 (a) IN GENERAL.—To the extent that a group health 

8 plan, or health insurance coverage offered by a health in9 surance issuer, provides coverage for benefits with respect 

10 to prescription drugs, and limits such coverage to drugs 

11 included in a formulary, the plan or issuer shall—

12 (1) ensure the participation of physicians and 

13 pharmacists in developing and reviewing such for14 mulary; 

15 (2) provide for disclosure of the formulary to 

16 providers; and 

17 (3) in accordance with the applicable quality as18 surance and utilization review standards of the plan 

19 or issuer, provide for exceptions from the formulary 

20 limitation when a non-formulary alternative is medi21 cally necessary and appropriate and, in the case of 

22 such an exception, apply the same cost-sharing re23 quirements that would have applied in the case of a 

24 drug covered under the formulary. 
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•S 1945 IS 

1 (b) COVERAGE OF APPROVED DRUGS AND MEDICAL

2 DEVICES.—

3 (1) IN GENERAL.—A group health plan (or 

4 health insurance coverage offered in connection with 

5 such a plan) that provides any coverage of prescrip6 tion drugs or medical devices shall not deny coverage 

7 of such a drug or device on the basis that the use 

8 is investigational, if the use—

9 (A) in the case of a prescription drug—

10 (i) is included in the labeling author11 ized by the application in effect for the 

12 drug pursuant to subsection (b) or (j) of 

13 section 505 of the Federal Food, Drug, 

14 and Cosmetic Act, without regard to any 

15 postmarketing requirements that may 

16 apply under such Act; or 

17 (ii) is included in the labeling author18 ized by the application in effect for the 

19 drug under section 351 of the Public 

20 Health Service Act, without regard to any 

21 postmarketing requirements that may 

22 apply pursuant to such section; or 

23 (B) in the case of a medical device, is in24 cluded in the labeling authorized by a regula25 tion under subsection (d) or (3) of section 513 
102

•S 1945 IS 

1 of the Federal Food, Drug, and Cosmetic Act, 

2 an order under subsection (f) of such section, or 

3 an application approved under section 515 of 

4 such Act, without regard to any postmarketing 

5 requirements that may apply under such Act. 

6 (2) CONSTRUCTION.—Nothing in this sub7 section shall be construed as requiring a group 

8 health plan (or health insurance coverage offered in 

9 connection with such a plan) to provide any coverage 

10 of prescription drugs or medical devices. 

11 SEC. 119. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 

12 APPROVED CLINICAL TRIALS. 

13 (a) COVERAGE.—

14 (1) IN GENERAL.—If a group health plan, or 

15 health insurance issuer that is providing health in16 surance coverage, provides coverage to a qualified in17 dividual (as defined in subsection (b)), the plan or 

18 issuer—

19 (A) may not deny the individual participa20 tion in the clinical trial referred to in subsection 

21 (b)(2); 

22 (B) subject to subsection (c), may not deny 

23 (or limit or impose additional conditions on) the 

24 coverage of routine patient costs for items and
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•S 1945 IS 

1 services furnished in connection with participa2 tion in the trial; and 

3 (C) may not discriminate against the indi4 vidual on the basis of the enrollee’s participa5 tion in such trial. 

6 (2) EXCLUSION OF CERTAIN COSTS.—For pur7 poses of paragraph (1)(B), routine patient costs do 

8 not include the cost of the tests or measurements 

9 conducted primarily for the purpose of the clinical 

10 trial involved. 

11 (3) USE OF IN-NETWORK PROVIDERS.—If one 

12 or more participating providers is participating in a 

13 clinical trial, nothing in paragraph (1) shall be con14 strued as preventing a plan or issuer from requiring 

15 that a qualified individual participate in the trial 

16 through such a participating provider if the provider 

17 will accept the individual as a participant in the 

18 trial. 

19 (b) QUALIFIED INDIVIDUAL DEFINED.—For pur20 poses of subsection (a), the term ‘‘qualified individual’’ 

21 means an individual who is a participant or beneficiary 

22 in a group health plan, or who is an enrollee under health 

23 insurance coverage, and who meets the following condi24 tions: 
104

•S 1945 IS 

1 (1)(A) The individual has a life-threatening or 

2 serious illness for which no standard treatment is ef3 fective. 

4 (B) The individual is eligible to participate in 

5 an approved clinical trial according to the trial pro6 tocol with respect to treatment of such illness. 

7 (C) The individual’s participation in the trial 

8 offers meaningful potential for significant clinical 

9 benefit for the individual. 

10 (2) Either—

11 (A) the referring physician is a partici12 pating health care professional and has con13 cluded that the individual’s participation in 

14 such trial would be appropriate based upon the 

15 individual meeting the conditions described in 

16 paragraph (1); or 

17 (B) the participant, beneficiary, or enrollee 

18 provides medical and scientific information es19 tablishing that the individual’s participation in 

20 such trial would be appropriate based upon the 

21 individual meeting the conditions described in 

22 paragraph (1). 

23 (c) PAYMENT.—

24 (1) IN GENERAL.—Under this section a group 

25 health plan or health insurance issuer shall provide 
105

•S 1945 IS 

1 for payment for routine patient costs described in 

2 subsection (a)(2) but is not required to pay for costs 

3 of items and services that are reasonably expected 

4 (as determined by the appropriate Secretary) to be 

5 paid for by the sponsors of an approved clinical trial. 

6 (2) PAYMENT RATE.—In the case of covered 

7 items and services provided by—

8 (A) a participating provider, the payment 

9 rate shall be at the agreed upon rate; or 

10 (B) a nonparticipating provider, the pay11 ment rate shall be at the rate the plan or issuer 

12 would normally pay for comparable services 

13 under subparagraph (A). 

14 (d) APPROVED CLINICAL TRIAL DEFINED.—

15 (1) IN GENERAL.—In this section, the term 

16 ‘‘approved clinical trial’’ means a clinical research 

17 study or clinical investigation—

18 (A) approved and funded (which may in19 clude funding through in-kind contributions) by 

20 one or more of the following: 

21 (i) the National Institutes of Health; 

22 (ii) a cooperative group or center of 

23 the National Institutes of Health, such as 

24 a qualified nongovernmental research enti-
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•S 1945 IS 

1 ty to which the National Cancer Institute 

2 has awarded a center support grant; 

3 (iii) either of the following if the con4 ditions described in paragraph (2) are 

5 met—

6 (I) the Department of Veterans 

7 Affairs; 

8 (II) the Department of Defense; 

9 or 

10 (B) approved by the Food and Drug Ad11 ministration. 

12 (2) CONDITIONS FOR DEPARTMENTS.—The 

13 conditions described in this paragraph, for a study 

14 or investigation conducted by a Department, are 

15 that the study or investigation has been reviewed 

16 and approved through a system of peer review that 

17 the appropriate Secretary determines—

18 (A) to be comparable to the system of peer 

19 review of studies and investigations used by the 

20 National Institutes of Health; and 

21 (B) assures unbiased review of the highest 

22 ethical standards by qualified individuals who 

23 have no interest in the outcome of the review.
107

•S 1945 IS 

1 (e) CONSTRUCTION.—Nothing in this section shall be 

2 construed to limit a plan’s or issuer’s coverage with re3 spect to clinical trials. 

4 SEC. 120. REQUIRED COVERAGE FOR MINIMUM HOSPITAL 

5 STAY FOR MASTECTOMIES AND LYMPH NODE 

6 DISSECTIONS FOR THE TREATMENT OF 

7 BREAST CANCER AND COVERAGE FOR SEC8 ONDARY CONSULTATIONS. 

9 (a) INPATIENT CARE.—

10 (1) IN GENERAL.—A group health plan, and a 

11 health insurance issuer providing health insurance 

12 coverage, that provides medical and surgical benefits 

13 shall ensure that inpatient coverage with respect to 

14 the treatment of breast cancer is provided for a pe15 riod of time as is determined by the attending physi16 cian, in consultation with the patient, to be medi17 cally necessary and appropriate following—

18 (A) a mastectomy; 

19 (B) a lumpectomy; or 

20 (C) a lymph node dissection for the treat21 ment of breast cancer. 

22 (2) EXCEPTION.—Nothing in this section shall 

23 be construed as requiring the provision of inpatient 

24 coverage if the attending physician and patient de-
108

•S 1945 IS 

1 termine that a shorter period of hospital stay is 

2 medically appropriate. 

3 (b) PROHIBITION ON CERTAIN MODIFICATIONS.—In 

4 implementing the requirements of this section, a group 

5 health plan, and a health insurance issuer providing health 

6 insurance coverage, may not modify the terms and condi7 tions of coverage based on the determination by a partici8 pant, beneficiary, or enrollee to request less than the min9 imum coverage required under subsection (a). 

10 (c) SECONDARY CONSULTATIONS.—

11 (1) IN GENERAL.—A group health plan, and a 

12 health insurance issuer providing health insurance 

13 coverage, that provides coverage with respect to 

14 medical and surgical services provided in relation to 

15 the diagnosis and treatment of cancer shall ensure 

16 that full coverage is provided for secondary consulta17 tions by specialists in the appropriate medical fields 

18 (including pathology, radiology, and oncology) to 

19 confirm or refute such diagnosis. Such plan or issuer 

20 shall ensure that full coverage is provided for such 

21 secondary consultation whether such consultation is 

22 based on a positive or negative initial diagnosis. In 

23 any case in which the attending physician certifies in 

24 writing that services necessary for such a secondary 

25 consultation are not sufficiently available from spe-
109

•S 1945 IS 

1 cialists operating under the plan or coverage with re2 spect to whose services coverage is otherwise pro3 vided under such plan or by such issuer, such plan 

4 or issuer shall ensure that coverage is provided with 

5 respect to the services necessary for the secondary 

6 consultation with any other specialist selected by the 

7 attending physician for such purpose at no addi8 tional cost to the individual beyond that which the 

9 individual would have paid if the specialist was par10 ticipating in the network of the plan or issuer. 

11 (2) EXCEPTION.—Nothing in paragraph (1) 

12 shall be construed as requiring the provision of sec13 ondary consultations where the patient determines 

14 not to seek such a consultation. 

15 (d) PROHIBITION ON PENALTIES OR INCENTIVES.—

16 A group health plan, and a health insurance issuer pro17 viding health insurance coverage, may not—

18 (1) penalize or otherwise reduce or limit the re19 imbursement of a provider or specialist because the 

20 provider or specialist provided care to a participant, 

21 beneficiary, or enrollee in accordance with this sec22 tion; 

23 (2) provide financial or other incentives to a 

24 physician or specialist to induce the physician or 

25 specialist to keep the length of inpatient stays of pa-
110

•S 1945 IS 

1 tients following a mastectomy, lumpectomy, or a 

2 lymph node dissection for the treatment of breast 

3 cancer below certain limits or to limit referrals for 

4 secondary consultations; or 

5 (3) provide financial or other incentives to a 

6 physician or specialist to induce the physician or 

7 specialist to refrain from referring a participant, 

8 beneficiary, or enrollee for a secondary consultation 

9 that would otherwise be covered by the plan or cov10 erage involved under subsection (c). 

11 Subtitle C—Access to Information 

12 SEC. 121. PATIENT ACCESS TO INFORMATION. 

13 (a) REQUIREMENT.—

14 (1) DISCLOSURE.—

15 (A) IN GENERAL.—A group health plan, 

16 and a health insurance issuer that provides cov17 erage in connection with health insurance cov18 erage, shall provide for the disclosure to partici19 pants, beneficiaries, and enrollees—

20 (i) of the information described in 

21 subsection (b) at the time of the initial en22 rollment of the participant, beneficiary, or 

23 enrollee under the plan or coverage; 

24 (ii) of such information on an annual 

25 basis—
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•S 1945 IS 

1 (I) in conjunction with the elec2 tion period of the plan or coverage if 

3 the plan or coverage has such an elec4 tion period; or 

5 (II) in the case of a plan or cov6 erage that does not have an election 

7 period, in conjunction with the begin8 ning of the plan or coverage year; and 

9 (iii) of information relating to any 

10 material reduction to the benefits or infor11 mation described in such subsection or 

12 subsection (c), in the form of a notice pro13 vided not later than 30 days before the 

14 date on which the reduction takes effect. 

15 (B) PARTICIPANTS, BENEFICIARIES, AND

16 ENROLLEES.—The disclosure required under 

17 subparagraph (A) shall be provided—

18 (i) jointly to each participant, bene19 ficiary, and enrollee who reside at the same 

20 address; or 

21 (ii) in the case of a beneficiary or en22 rollee who does not reside at the same ad23 dress as the participant or another en24 rollee, separately to the participant or
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1 other enrollees and such beneficiary or en2 rollee. 

3 (2) PROVISION OF INFORMATION.—Information 

4 shall be provided to participants, beneficiaries, and 

5 enrollees under this section at the last known ad6 dress maintained by the plan or issuer with respect 

7 to such participants, beneficiaries, or enrollees, to 

8 the extent that such information is provided to par9 ticipants, beneficiaries, or enrollees via the United 

10 States Postal Service or other private delivery serv11 ice. 

12 (b) REQUIRED INFORMATION.—The informational 

13 materials to be distributed under this section shall include 

14 for each option available under the group health plan or 

15 health insurance coverage the following: 

16 (1) BENEFITS.—A description of the covered 

17 benefits, including—

18 (A) any in- and out-of-network benefits; 

19 (B) specific preventive services covered 

20 under the plan or coverage if such services are 

21 covered; 

22 (C) any specific exclusions or express limi23 tations of benefits described in section 

24 104(d)(3)(C); 
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1 (D) any other benefit limitations, including 

2 any annual or lifetime benefit limits and any 

3 monetary limits or limits on the number of vis4 its, days, or services, and any specific coverage 

5 exclusions; and 

6 (E) any definition of medical necessity 

7 used in making coverage determinations by the 

8 plan, issuer, or claims administrator. 

9 (2) COST SHARING.—A description of any cost10 sharing requirements, including—

11 (A) any premiums, deductibles, coinsur12 ance, copayment amounts, and liability for bal13 ance billing, for which the participant, bene14 ficiary, or enrollee will be responsible under 

15 each option available under the plan; 

16 (B) any maximum out-of-pocket expense 

17 for which the participant, beneficiary, or en18 rollee may be liable; 

19 (C) any cost-sharing requirements for out20 of-network benefits or services received from 

21 nonparticipating providers; and 

22 (D) any additional cost-sharing or charges 

23 for benefits and services that are furnished 

24 without meeting applicable plan or coverage re-
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1 quirements, such as prior authorization or 

2 precertification. 

3 (3) DISENROLLMENT.—Information relating to 

4 the disenrollment of a participant, beneficiary, or en5 rollee. 

6 (4) SERVICE AREA.—A description of the plan 

7 or issuer’s service area, including the provision of 

8 any out-of-area coverage. 

9 (5) PARTICIPATING PROVIDERS.—A directory of 

10 participating providers (to the extent a plan or 

11 issuer provides coverage through a network of pro12 viders) that includes, at a minimum, the name, ad13 dress, and telephone number of each participating 

14 provider, and information about how to inquire 

15 whether a participating provider is currently accept16 ing new patients. 

17 (6) CHOICE OF PRIMARY CARE PROVIDER.—A 

18 description of any requirements and procedures to 

19 be used by participants, beneficiaries, and enrollees 

20 in selecting, accessing, or changing their primary 

21 care provider, including providers both within and 

22 outside of the network (if the plan or issuer permits 

23 out-of-network services), and the right to select a pe24 diatrician as a primary care provider under section 
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•S 1945 IS 

1 116 for a participant, beneficiary, or enrollee who is 

2 a child if such section applies. 

3 (7) PREAUTHORIZATION REQUIREMENTS.—A 

4 description of the requirements and procedures to be 

5 used to obtain preauthorization for health services, 

6 if such preauthorization is required. 

7 (8) EXPERIMENTAL AND INVESTIGATIONAL

8 TREATMENTS.—A description of the process for de9 termining whether a particular item, service, or 

10 treatment is considered experimental or investiga11 tional, and the circumstances under which such 

12 treatments are covered by the plan or issuer. 

13 (9) SPECIALTY CARE.—A description of the re14 quirements and procedures to be used by partici15 pants, beneficiaries, and enrollees in accessing spe16 cialty care and obtaining referrals to participating 

17 and nonparticipating specialists, including any limi18 tations on choice of health care professionals re19 ferred to in section 112(b)(2) and the right to timely 

20 access to specialists care under section 114 if such 

21 section applies. 

22 (10) CLINICAL TRIALS.—A description of the 

23 circumstances and conditions under which participa24 tion in clinical trials is covered under the terms and 

25 conditions of the plan or coverage, and the right to 
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•S 1945 IS 

1 obtain coverage for approved clinical trials under 

2 section 119 if such section applies. 

3 (11) PRESCRIPTION DRUGS.—To the extent the 

4 plan or issuer provides coverage for prescription 

5 drugs, a statement of whether such coverage is lim6 ited to drugs included in a formulary, a description 

7 of any provisions and cost-sharing required for ob8 taining on- and off-formulary medications, and a de9 scription of the rights of participants, beneficiaries, 

10 and enrollees in obtaining access to access to pre11 scription drugs under section 118 if such section ap12 plies. 

13 (12) EMERGENCY SERVICES.—A summary of 

14 the rules and procedures for accessing emergency 

15 services, including the right of a participant, bene16 ficiary, or enrollee to obtain emergency services 

17 under the prudent layperson standard under section 

18 113, if such section applies, and any educational in19 formation that the plan or issuer may provide re20 garding the appropriate use of emergency services. 

21 (13) CLAIMS AND APPEALS.—A description of 

22 the plan or issuer’s rules and procedures pertaining 

23 to claims and appeals, a description of the rights 

24 (including deadlines for exercising rights) of partici25 pants, beneficiaries, and enrollees under subtitle A
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•S 1945 IS 

1 in obtaining covered benefits, filing a claim for bene2 fits, and appealing coverage decisions internally and 

3 externally (including telephone numbers and mailing 

4 addresses of the appropriate authority), and a de5 scription of any additional legal rights and remedies 

6 available under section 502 of the Employee Retire7 ment Income Security Act of 1974 and applicable 

8 State law. 

9 (14) ADVANCE DIRECTIVES AND ORGAN DONA10 TION.—A description of procedures for advance di11 rectives and organ donation decisions if the plan or 

12 issuer maintains such procedures. 

13 (15) INFORMATION ON PLANS AND ISSUERS.—

14 The name, mailing address, and telephone number 

15 or numbers of the plan administrator and the issuer 

16 to be used by participants, beneficiaries, and enroll17 ees seeking information about plan or coverage bene18 fits and services, payment of a claim, or authoriza19 tion for services and treatment. Notice of whether 

20 the benefits under the plan or coverage are provided 

21 under a contract or policy of insurance issued by an 

22 issuer, or whether benefits are provided directly by 

23 the plan sponsor who bears the insurance risk. 

24 (16) TRANSLATION SERVICES.—A summary de25 scription of any translation or interpretation services 
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•S 1945 IS 

1 (including the availability of printed information in 

2 languages other than English, audio tapes, or infor3 mation in Braille) that are available for non-English 

4 speakers and participants, beneficiaries, and enroll5 ees with communication disabilities and a description 

6 of how to access these items or services. 

7 (17) ACCREDITATION INFORMATION.—Any in8 formation that is made public by accrediting organi9 zations in the process of accreditation if the plan or 

10 issuer is accredited, or any additional quality indica11 tors (such as the results of enrollee satisfaction sur12 veys) that the plan or issuer makes public or makes 

13 available to participants, beneficiaries, and enrollees. 

14 (18) NOTICE OF REQUIREMENTS.—A descrip15 tion of any rights of participants, beneficiaries, and 

16 enrollees that are established by the Bipartisan Pa17 tient Protection Act (excluding those described in 

18 paragraphs (1) through (17)) if such sections apply. 

19 The description required under this paragraph may 

20 be combined with the notices of the type described 

21 in sections 711(d), 713(b), or 606(a)(1) of the Em22 ployee Retirement Income Security Act of 1974 and 

23 with any other notice provision that the appropriate 

24 Secretary determines may be combined, so long as 

25 such combination does not result in any reduction in 
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•S 1945 IS 

1 the information that would otherwise be provided to 

2 the recipient. 

3 (19) AVAILABILITY OF ADDITIONAL INFORMA4 TION.—A statement that the information described 

5 in subsection (c), and instructions on obtaining such 

6 information (including telephone numbers and, if 

7 available, Internet websites), shall be made available 

8 upon request. 

9 (20) DESIGNATED DECISIONMAKERS.—A de10 scription of the participants and beneficiaries with 

11 respect to whom each designated decisionmaker 

12 under the plan has assumed liability under section 

13 502(o) of the Employee Retirement Income Security 

14 Act of 1974 and the name and address of each such 

15 decisionmaker. 

16 (c) ADDITIONAL INFORMATION.—The informational 

17 materials to be provided upon the request of a participant, 

18 beneficiary, or enrollee shall include for each option avail19 able under a group health plan or health insurance cov20 erage the following: 

21 (1) STATUS OF PROVIDERS.—The State licen22 sure status of the plan or issuer’s participating 

23 health care professionals and participating health 

24 care facilities, and, if available, the education, train-
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•S 1945 IS 

1 ing, specialty qualifications or certifications of such 

2 professionals. 

3 (2) COMPENSATION METHODS.—A summary 

4 description by category of the applicable methods 

5 (such as capitation, fee-for-service, salary, bundled 

6 payments, per diem, or a combination thereof) used 

7 for compensating prospective or treating health care 

8 professionals (including primary care providers and 

9 specialists) and facilities in connection with the pro10 vision of health care under the plan or coverage. 

11 (3) PRESCRIPTION DRUGS.—Information about 

12 whether a specific prescription medication is in13 cluded in the formulary of the plan or issuer, if the 

14 plan or issuer uses a defined formulary. 

15 (4) UTILIZATION REVIEW ACTIVITIES.—A de16 scription of procedures used and requirements (in17 cluding circumstances, timeframes, and appeals 

18 rights) under any utilization review program under 

19 sections 101 and 102, including any drug formulary 

20 program under section 118. 

21 (5) EXTERNAL APPEALS INFORMATION.—Ag22 gregate information on the number and outcomes of 

23 external medical reviews, relative to the sample size 

24 (such as the number of covered lives) under the plan 

25 or under the coverage of the issuer. 
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•S 1945 IS 

1 (d) MANNER OF DISCLOSURE.—The information de2 scribed in this section shall be disclosed in an accessible 

3 medium and format that is calculated to be understood 

4 by a participant or enrollee. 

5 (e) RULES OF CONSTRUCTION.—Nothing in this sec6 tion shall be construed to prohibit a group health plan, 

7 or a health insurance issuer in connection with health in8 surance coverage, from—

9 (1) distributing any other additional informa10 tion determined by the plan or issuer to be impor11 tant or necessary in assisting participants, bene12 ficiaries, and enrollees in the selection of a health 

13 plan or health insurance coverage; and 

14 (2) complying with the provisions of this section 

15 by providing information in brochures, through the 

16 Internet or other electronic media, or through other 

17 similar means, so long as—

18 (A) the disclosure of such information in 

19 such form is in accordance with requirements 

20 as the appropriate Secretary may impose, and 

21 (B) in connection with any such disclosure 

22 of information through the Internet or other 

23 electronic media—
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•S 1945 IS 

1 (i) the recipient has affirmatively con2 sented to the disclosure of such informa3 tion in such form, 

4 (ii) the recipient is capable of access5 ing the information so disclosed on the re6 cipient’s individual workstation or at the 

7 recipient’s home, 

8 (iii) the recipient retains an ongoing 

9 right to receive paper disclosure of such in10 formation and receives, in advance of any 

11 attempt at disclosure of such information 

12 to him or her through the Internet or 

13 other electronic media, notice in printed 

14 form of such ongoing right and of the 

15 proper software required to view informa16 tion so disclosed, and 

17 (iv) the plan administrator appro18 priately ensures that the intended recipient 

19 is receiving the information so disclosed 

20 and provides the information in printed 

21 form if the information is not received. 
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•S 1945 IS 

1 Subtitle D—Protecting the Doctor2 Patient Relationship 

3 SEC. 131. PROHIBITION OF INTERFERENCE WITH CERTAIN 

4 MEDICAL COMMUNICATIONS. 

5 (a) GENERAL RULE.—The provisions of any contract 

6 or agreement, or the operation of any contract or agree7 ment, between a group health plan or health insurance 

8 issuer in relation to health insurance coverage (including 

9 any partnership, association, or other organization that 

10 enters into or administers such a contract or agreement) 

11 and a health care provider (or group of health care pro12 viders) shall not prohibit or otherwise restrict a health 

13 care professional from advising such a participant, bene14 ficiary, or enrollee who is a patient of the professional 

15 about the health status of the individual or medical care 

16 or treatment for the individual’s condition or disease, re17 gardless of whether benefits for such care or treatment 

18 are provided under the plan or coverage, if the professional 

19 is acting within the lawful scope of practice. 

20 (b) NULLIFICATION.—Any contract provision or 

21 agreement that restricts or prohibits medical communica22 tions in violation of subsection (a) shall be null and void. 
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•S 1945 IS 

1 SEC. 132. PROHIBITION OF DISCRIMINATION AGAINST PRO2 VIDERS BASED ON LICENSURE. 

3 (a) IN GENERAL.—A group health plan, and a health 

4 insurance issuer with respect to health insurance coverage, 

5 shall not discriminate with respect to participation or in6 demnification as to any provider who is acting within the 

7 scope of the provider’s license or certification under appli8 cable State law, solely on the basis of such license or cer9 tification. 

10 (b) CONSTRUCTION.—Subsection (a) shall not be con11 strued—

12 (1) as requiring the coverage under a group 

13 health plan or health insurance coverage of a par14 ticular benefit or service or to prohibit a plan or 

15 issuer from including providers only to the extent 

16 necessary to meet the needs of the plan’s or issuer’s 

17 participants, beneficiaries, or enrollees or from es18 tablishing any measure designed to maintain quality 

19 and control costs consistent with the responsibilities 

20 of the plan or issuer; 

21 (2) to override any State licensure or scope-of22 practice law; or 

23 (3) as requiring a plan or issuer that offers net24 work coverage to include for participation every will25 ing provider who meets the terms and conditions of 

26 the plan or issuer. 
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•S 1945 IS 

1 SEC. 133. PROHIBITION AGAINST IMPROPER INCENTIVE 

2 ARRANGEMENTS. 

3 (a) IN GENERAL.—A group health plan and a health 

4 insurance issuer offering health insurance coverage may 

5 not operate any physician incentive plan (as defined in 

6 subparagraph (B) of section 1876(i)(8) of the Social Secu7 rity Act) unless the requirements described in clauses (i), 

8 (ii)(I), and (iii) of subparagraph (A) of such section are 

9 met with respect to such a plan. 

10 (b) APPLICATION.—For purposes of carrying out 

11 paragraph (1), any reference in section 1876(i)(8) of the 

12 Social Security Act to the Secretary, an eligible organiza13 tion, or an individual enrolled with the organization shall 

14 be treated as a reference to the applicable authority, a 

15 group health plan or health insurance issuer, respectively, 

16 and a participant, beneficiary, or enrollee with the plan 

17 or organization, respectively. 

18 (c) CONSTRUCTION.—Nothing in this section shall be 

19 construed as prohibiting all capitation and similar ar20 rangements or all provider discount arrangements. 

21 SEC. 134. PAYMENT OF CLAIMS. 

22 A group health plan, and a health insurance issuer 

23 offering group health insurance coverage, shall provide for 

24 prompt payment of claims submitted for health care serv25 ices or supplies furnished to a participant, beneficiary, or 

26 enrollee with respect to benefits covered by the plan or 
126

•S 1945 IS 

1 issuer, in a manner consistent with the provisions of sec2 tion 1842(c)(2) of the Social Security Act (42 U.S.C. 

3 1395u(c)(2)). 

4 SEC. 135. PROTECTION FOR PATIENT ADVOCACY. 

5 (a) PROTECTION FOR USE OF UTILIZATION REVIEW

6 AND GRIEVANCE PROCESS.—A group health plan, and a 

7 health insurance issuer with respect to the provision of 

8 health insurance coverage, may not retaliate against a par9 ticipant, beneficiary, enrollee, or health care provider 

10 based on the participant’s, beneficiary’s, enrollee’s or pro11 vider’s use of, or participation in, a utilization review proc12 ess or a grievance process of the plan or issuer (including 

13 an internal or external review or appeal process) under 

14 this title. 

15 (b) PROTECTION FOR QUALITY ADVOCACY BY

16 HEALTH CARE PROFESSIONALS.—

17 (1) IN GENERAL.—A group health plan or 

18 health insurance issuer may not retaliate or dis19 criminate against a protected health care profes20 sional because the professional in good faith—

21 (A) discloses information relating to the 

22 care, services, or conditions affecting one or 

23 more participants, beneficiaries, or enrollees of 

24 the plan or issuer to an appropriate public reg25 ulatory agency, an appropriate private accredi-
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•S 1945 IS 

1 tation body, or appropriate management per2 sonnel of the plan or issuer; or 

3 (B) initiates, cooperates, or otherwise par4 ticipates in an investigation or proceeding by 

5 such an agency with respect to such care, serv6 ices, or conditions. 

7 If an institutional health care provider is a partici8 pating provider with such a plan or issuer or other9 wise receives payments for benefits provided by such 

10 a plan or issuer, the provisions of the previous sen11 tence shall apply to the provider in relation to care, 

12 services, or conditions affecting one or more patients 

13 within an institutional health care provider in the 

14 same manner as they apply to the plan or issuer in 

15 relation to care, services, or conditions provided to 

16 one or more participants, beneficiaries, or enrollees; 

17 and for purposes of applying this sentence, any ref18 erence to a plan or issuer is deemed a reference to 

19 the institutional health care provider. 

20 (2) GOOD FAITH ACTION.—For purposes of 

21 paragraph (1), a protected health care professional 

22 is considered to be acting in good faith with respect 

23 to disclosure of information or participation if, with 

24 respect to the information disclosed as part of the 

25 action—
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•S 1945 IS 

1 (A) the disclosure is made on the basis of 

2 personal knowledge and is consistent with that 

3 degree of learning and skill ordinarily possessed 

4 by health care professionals with the same li5 censure or certification and the same experi6 ence; 

7 (B) the professional reasonably believes the 

8 information to be true; 

9 (C) the information evidences either a vio10 lation of a law, rule, or regulation, of an appli11 cable accreditation standard, or of a generally 

12 recognized professional or clinical standard or 

13 that a patient is in imminent hazard of loss of 

14 life or serious injury; and 

15 (D) subject to subparagraphs (B) and (C) 

16 of paragraph (3), the professional has followed 

17 reasonable internal procedures of the plan, 

18 issuer, or institutional health care provider es19 tablished for the purpose of addressing quality 

20 concerns before making the disclosure. 

21 (3) EXCEPTION AND SPECIAL RULE.—

22 (A) GENERAL EXCEPTION.—Paragraph (1) 

23 does not protect disclosures that would violate 

24 Federal or State law or diminish or impair the 

25 rights of any person to the continued protection 
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•S 1945 IS 

1 of confidentiality of communications provided 

2 by such law. 

3 (B) NOTICE OF INTERNAL PROCEDURES.—

4 Subparagraph (D) of paragraph (2) shall not 

5 apply unless the internal procedures involved 

6 are reasonably expected to be known to the 

7 health care professional involved. For purposes 

8 of this subparagraph, a health care professional 

9 is reasonably expected to know of internal pro10 cedures if those procedures have been made 

11 available to the professional through distribu12 tion or posting. 

13 (C) INTERNAL PROCEDURE EXCEPTION.—

14 Subparagraph (D) of paragraph (2) also shall 

15 not apply if—

16 (i) the disclosure relates to an immi17 nent hazard of loss of life or serious injury 

18 to a patient; 

19 (ii) the disclosure is made to an ap20 propriate private accreditation body pursu21 ant to disclosure procedures established by 

22 the body; or 

23 (iii) the disclosure is in response to an 

24 inquiry made in an investigation or pro25 ceeding of an appropriate public regulatory 
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•S 1945 IS 

1 agency and the information disclosed is 

2 limited to the scope of the investigation or 

3 proceeding. 

4 (4) ADDITIONAL CONSIDERATIONS.—It shall 

5 not be a violation of paragraph (1) to take an ad6 verse action against a protected health care profes7 sional if the plan, issuer, or provider taking the ad8 verse action involved demonstrates that it would 

9 have taken the same adverse action even in the ab10 sence of the activities protected under such para11 graph. 

12 (5) NOTICE.—A group health plan, health in13 surance issuer, and institutional health care provider 

14 shall post a notice, to be provided or approved by 

15 the Secretary of Labor, setting forth excerpts from, 

16 or summaries of, the pertinent provisions of this 

17 subsection and information pertaining to enforce18 ment of such provisions. 

19 (6) CONSTRUCTIONS.—

20 (A) DETERMINATIONS OF COVERAGE.—

21 Nothing in this subsection shall be construed to 

22 prohibit a plan or issuer from making a deter23 mination not to pay for a particular medical 

24 treatment or service or the services of a type of 

25 health care professional. 
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•S 1945 IS 

1 (B) ENFORCEMENT OF PEER REVIEW PRO2 TOCOLS AND INTERNAL PROCEDURES.—Noth3 ing in this subsection shall be construed to pro4 hibit a plan, issuer, or provider from estab5 lishing and enforcing reasonable peer review or 

6 utilization review protocols or determining 

7 whether a protected health care professional has 

8 complied with those protocols or from estab9 lishing and enforcing internal procedures for 

10 the purpose of addressing quality concerns. 

11 (C) RELATION TO OTHER RIGHTS.—Noth12 ing in this subsection shall be construed to 

13 abridge rights of participants, beneficiaries, en14 rollees, and protected health care professionals 

15 under other applicable Federal or State laws. 

16 (7) PROTECTED HEALTH CARE PROFESSIONAL

17 DEFINED.—For purposes of this subsection, the 

18 term ‘‘protected health care professional’’ means an 

19 individual who is a licensed or certified health care 

20 professional and who—

21 (A) with respect to a group health plan or 

22 health insurance issuer, is an employee of the 

23 plan or issuer or has a contract with the plan 

24 or issuer for provision of services for which ben25 efits are available under the plan or issuer; or 
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•S 1945 IS 

1 (B) with respect to an institutional health 

2 care provider, is an employee of the provider or 

3 has a contract or other arrangement with the 

4 provider respecting the provision of health care 

5 services. 

6 Subtitle E—Definitions 

7 SEC. 151. DEFINITIONS. 

8 (a) INCORPORATION OF GENERAL DEFINITIONS.—

9 Except as otherwise provided, the provisions of section 

10 2791 of the Public Health Service Act shall apply for pur11 poses of this title in the same manner as they apply for 

12 purposes of title XXVII of such Act. 

13 (b) SECRETARY.—Except as otherwise provided, the 

14 term ‘‘Secretary’’ means the Secretary of Health and 

15 Human Services, in consultation with the Secretary of 

16 Labor and the term ‘‘appropriate Secretary’’ means the 

17 Secretary of Health and Human Services in relation to 

18 carrying out this title under sections 2706 and 2751 of 

19 the Public Health Service Act and the Secretary of Labor 

20 in relation to carrying out this title under section 713 of 

21 the Employee Retirement Income Security Act of 1974. 

22 (c) ADDITIONAL DEFINITIONS.—For purposes of this 

23 title: 

24 (1) APPLICABLE AUTHORITY.—The term ‘‘ap25 plicable authority’’ means—
133

•S 1945 IS 

1 (A) in the case of a group health plan, the 

2 Secretary of Health and Human Services and 

3 the Secretary of Labor; and 

4 (B) in the case of a health insurance issuer 

5 with respect to a specific provision of this title, 

6 the applicable State authority (as defined in 

7 section 2791(d) of the Public Health Service 

8 Act), or the Secretary of Health and Human 

9 Services, if such Secretary is enforcing such 

10 provision under section 2722(a)(2) or 

11 2761(a)(2) of the Public Health Service Act. 

12 (2) ENROLLEE.—The term ‘‘enrollee’’ means, 

13 with respect to health insurance coverage offered by 

14 a health insurance issuer, an individual enrolled with 

15 the issuer to receive such coverage. 

16 (3) GROUP HEALTH PLAN.—The term ‘‘group 

17 health plan’’ has the meaning given such term in 

18 section 733(a) of the Employee Retirement Income 

19 Security Act of 1974, except that such term includes 

20 a employee welfare benefit plan treated as a group 

21 health plan under section 732(d) of such Act or de22 fined as such a plan under section 607(1) of such 

23 Act. 

24 (4) HEALTH CARE PROFESSIONAL.—The term 

25 ‘‘health care professional’’ means an individual who 
134

•S 1945 IS 

1 is licensed, accredited, or certified under State law 

2 to provide specified health care services and who is 

3 operating within the scope of such licensure, accredi4 tation, or certification. 

5 (5) HEALTH CARE PROVIDER.—The term 

6 ‘‘health care provider’’ includes a physician or other 

7 health care professional, as well as an institutional 

8 or other facility or agency that provides health care 

9 services and that is licensed, accredited, or certified 

10 to provide health care items and services under ap11 plicable State law. 

12 (6) NETWORK.—The term ‘‘network’’ means, 

13 with respect to a group health plan or health insur14 ance issuer offering health insurance coverage, the 

15 participating health care professionals and providers 

16 through whom the plan or issuer provides health 

17 care items and services to participants, beneficiaries, 

18 or enrollees. 

19 (7) NONPARTICIPATING.—The term ‘‘non20 participating’’ means, with respect to a health care 

21 provider that provides health care items and services 

22 to a participant, beneficiary, or enrollee under group 

23 health plan or health insurance coverage, a health 

24 care provider that is not a participating health care 

25 provider with respect to such items and services. 
135

•S 1945 IS 

1 (8) PARTICIPATING.—The term ‘‘participating’’ 

2 means, with respect to a health care provider that 

3 provides health care items and services to a partici4 pant, beneficiary, or enrollee under group health 

5 plan or health insurance coverage offered by a 

6 health insurance issuer, a health care provider that 

7 furnishes such items and services under a contract 

8 or other arrangement with the plan or issuer. 

9 (9) PRIOR AUTHORIZATION.—The term ‘‘prior 

10 authorization’’ means the process of obtaining prior 

11 approval from a health insurance issuer or group 

12 health plan for the provision or coverage of medical 

13 services. 

14 (10) TERMS AND CONDITIONS.—The term 

15 ‘‘terms and conditions’’ includes, with respect to a 

16 group health plan or health insurance coverage, re17 quirements imposed under this title with respect to 

18 the plan or coverage. 

19 SEC. 152. PREEMPTION; STATE FLEXIBILITY; CONSTRUC20 TION. 

21 (a) CONTINUED APPLICABILITY OF STATE LAW

22 WITH RESPECT TO HEALTH INSURANCE ISSUERS.—

23 (1) IN GENERAL.—Subject to paragraph (2), 

24 this title shall not be construed to supersede any 

25 provision of State law which establishes, implements, 
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•S 1945 IS 

1 or continues in effect any standard or requirement 

2 solely relating to health insurance issuers (in connec3 tion with group health insurance coverage or other4 wise) except to the extent that such standard or re5 quirement prevents the application of a requirement 

6 of this title. 

7 (2) CONTINUED PREEMPTION WITH RESPECT

8 TO GROUP HEALTH PLANS.—Nothing in this title 

9 shall be construed to affect or modify the provisions 

10 of section 514 of the Employee Retirement Income 

11 Security Act of 1974 with respect to group health 

12 plans. 

13 (3) CONSTRUCTION.—In applying this section, 

14 a State law that provides for equal access to, and 

15 availability of, all categories of licensed health care 

16 providers and services shall not be treated as pre17 venting the application of any requirement of this 

18 title. 

19 (b) APPLICATION OF SUBSTANTIALLY COMPLIANT

20 STATE LAWS.—

21 (1) IN GENERAL.—In the case of a State law 

22 that imposes, with respect to health insurance cov23 erage offered by a health insurance issuer and with 

24 respect to a group health plan that is a non-Federal 

25 governmental plan, a requirement that substantially 
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1 complies (within the meaning of subsection (c)) with 

2 a patient protection requirement (as defined in para3 graph (3)) and does not prevent the application of 

4 other requirements under this Act (except in the 

5 case of other substantially compliant requirements), 

6 in applying the requirements of this title under sec7 tion 2707 and 2753 (as applicable) of the Public 

8 Health Service Act (as added by title II), subject to 

9 subsection (a)(2)—

10 (A) the State law shall not be treated as 

11 being superseded under subsection (a); and 

12 (B) the State law shall apply instead of the 

13 patient protection requirement otherwise appli14 cable with respect to health insurance coverage 

15 and non-Federal governmental plans. 

16 (2) LIMITATION.—In the case of a group health 

17 plan covered under title I of the Employee Retire18 ment Income Security Act of 1974, paragraph (1) 

19 shall be construed to apply only with respect to the 

20 health insurance coverage (if any) offered in connec21 tion with the plan. 

22 (3) DEFINITIONS.—In this section: 

23 (A) PATIENT PROTECTION REQUIRE24 MENT.—The term ‘‘patient protection require25 ment’’ means a requirement under this title,
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•S 1945 IS 

1 and includes (as a single requirement) a group 

2 or related set of requirements under a section 

3 or similar unit under this title. 

4 (B) SUBSTANTIALLY COMPLIANT.—The 

5 terms ‘‘substantially compliant’’, substantially 

6 complies’’, or ‘‘substantial compliance’’ with re7 spect to a State law, mean that the State law 

8 has the same or similar features as the patient 

9 protection requirements and has a similar ef10 fect. 

11 (c) DETERMINATIONS OF SUBSTANTIAL COMPLI12 ANCE.—

13 (1) CERTIFICATION BY STATES.—A State may 

14 submit to the Secretary a certification that a State 

15 law provides for patient protections that are at least 

16 substantially compliant with one or more patient 

17 protection requirements. Such certification shall be 

18 accompanied by such information as may be re19 quired to permit the Secretary to make the deter20 mination described in paragraph (2)(A). 

21 (2) REVIEW.—

22 (A) IN GENERAL.—The Secretary shall 

23 promptly review a certification submitted under 

24 paragraph (1) with respect to a State law to de25 termine if the State law substantially complies 
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1 with the patient protection requirement (or re2 quirements) to which the law relates. 

3 (B) APPROVAL DEADLINES.—

4 (i) INITIAL REVIEW.—Such a certifi5 cation is considered approved unless the 

6 Secretary notifies the State in writing, 

7 within 90 days after the date of receipt of 

8 the certification, that the certification is 

9 disapproved (and the reasons for dis10 approval) or that specified additional infor11 mation is needed to make the determina12 tion described in subparagraph (A). 

13 (ii) ADDITIONAL INFORMATION.—

14 With respect to a State that has been noti15 fied by the Secretary under clause (i) that 

16 specified additional information is needed 

17 to make the determination described in 

18 subparagraph (A), the Secretary shall 

19 make the determination within 60 days 

20 after the date on which such specified ad21 ditional information is received by the Sec22 retary. 

23 (3) APPROVAL.—
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•S 1945 IS 

1 (A) IN GENERAL.—The Secretary shall ap2 prove a certification under paragraph (1) un3 less—

4 (i) the State fails to provide sufficient 

5 information to enable the Secretary to 

6 make a determination under paragraph 

7 (2)(A); or 

8 (ii) the Secretary determines that the 

9 State law involved does not provide for pa10 tient protections that substantially comply 

11 with the patient protection requirement (or 

12 requirements) to which the law relates. 

13 (B) STATE CHALLENGE.—A State that has 

14 a certification disapproved by the Secretary 

15 under subparagraph (A) may challenge such 

16 disapproval in the appropriate United States 

17 district court. 

18 (C) DEFERENCE TO STATES.—With re19 spect to a certification submitted under para20 graph (1), the Secretary shall give deference to 

21 the State’s interpretation of the State law in22 volved with respect to the patient protection in23 volved. 

24 (D) PUBLIC NOTIFICATION.—The Sec25 retary shall—
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•S 1945 IS 

1 (i) provide a State with a notice of the 

2 determination to approve or disapprove a 

3 certification under this paragraph; 

4 (ii) promptly publish in the Federal 

5 Register a notice that a State has sub6 mitted a certification under paragraph (1); 

7 (iii) promptly publish in the Federal 

8 Register the notice described in clause (i) 

9 with respect to the State; and 

10 (iv) annually publish the status of all 

11 States with respect to certifications. 

12 (4) CONSTRUCTION.—Nothing in this sub13 section shall be construed as preventing the certifi14 cation (and approval of certification) of a State law 

15 under this subsection solely because it provides for 

16 greater protections for patients than those protec17 tions otherwise required to establish substantial 

18 compliance. 

19 (5) PETITIONS.—

20 (A) PETITION PROCESS.—Effective on the 

21 date on which the provisions of this Act become 

22 effective, as provided for in section 501, a 

23 group health plan, health insurance issuer, par24 ticipant, beneficiary, or enrollee may submit a 

25 petition to the Secretary for an advisory opinion 
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•S 1945 IS 

1 as to whether or not a standard or requirement 

2 under a State law applicable to the plan, issuer, 

3 participant, beneficiary, or enrollee that is not 

4 the subject of a certification under this sub5 section, is superseded under subsection (a)(1) 

6 because such standard or requirement prevents 

7 the application of a requirement of this title. 

8 (B) OPINION.—The Secretary shall issue 

9 an advisory opinion with respect to a petition 

10 submitted under subparagraph (A) within the 

11 60-day period beginning on the date on which 

12 such petition is submitted. 

13 (d) DEFINITIONS.—For purposes of this section: 

14 (1) STATE LAW.—The term ‘‘State law’’ in15 cludes all laws, decisions, rules, regulations, or other 

16 State action having the effect of law, of any State. 

17 A law of the United States applicable only to the 

18 District of Columbia shall be treated as a State law 

19 rather than a law of the United States. 

20 (2) STATE.—The term ‘‘State’’ includes a 

21 State, the District of Columbia, Puerto Rico, the 

22 Virgin Islands, Guam, American Samoa, the North23 ern Mariana Islands, any political subdivisions of 

24 such, or any agency or instrumentality of such.
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1 SEC. 153. EXCLUSIONS. 

2 (a) NO BENEFIT REQUIREMENTS.—Nothing in this 

3 title shall be construed to require a group health plan or 

4 a health insurance issuer offering health insurance cov5 erage to include specific items and services under the 

6 terms of such a plan or coverage, other than those pro7 vided under the terms and conditions of such plan or cov8 erage. 

9 (b) EXCLUSION FROM ACCESS TO CARE MANAGED

10 CARE PROVISIONS FOR FEE-FOR-SERVICE COVERAGE.—

11 (1) IN GENERAL.—The provisions of sections 

12 111 through 117 shall not apply to a group health 

13 plan or health insurance coverage if the only cov14 erage offered under the plan or coverage is fee-for15 service coverage (as defined in paragraph (2)). 

16 (2) FEE-FOR-SERVICE COVERAGE DEFINED.—

17 For purposes of this subsection, the term ‘‘fee-for18 service coverage’’ means coverage under a group 

19 health plan or health insurance coverage that—

20 (A) reimburses hospitals, health profes21 sionals, and other providers on a fee-for-service 

22 basis without placing the provider at financial 

23 risk; 

24 (B) does not vary reimbursement for such 

25 a provider based on an agreement to contract 
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•S 1945 IS 

1 terms and conditions or the utilization of health 

2 care items or services relating to such provider; 

3 (C) allows access to any provider that is 

4 lawfully authorized to provide the covered serv5 ices and that agrees to accept the terms and 

6 conditions of payment established under the 

7 plan or by the issuer; and 

8 (D) for which the plan or issuer does not 

9 require prior authorization before providing for 

10 any health care services. 

11 SEC. 154. COVERAGE OF LIMITED SCOPE PLANS. 

12 Only for purposes of applying the requirements of 

13 this title under sections 2707 and 2753 of the Public 

14 Health Service Act and section 714 of the Employee Re15 tirement Income Security Act of 1974, section 

16 2791(c)(2)(A), and section 733(c)(2)(A) of the Employee 

17 Retirement Income Security Act of 1974 shall be deemed 

18 not to apply. 

19 SEC. 155. REGULATIONS. 

20 The Secretaries of Health and Human Services and 

21 Labor shall issue such regulations as may be necessary 

22 or appropriate to carry out this title. Such regulations 

23 shall be issued consistent with section 104 of Health In24 surance Portability and Accountability Act of 1996. Such 

25 Secretaries may promulgate any interim final rules as the 
145

•S 1945 IS 

1 Secretaries determine are appropriate to carry out this 

2 title. 

3 SEC. 156. INCORPORATION INTO PLAN OR COVERAGE DOC4 UMENTS. 

5 The requirements of this title with respect to a group 

6 health plan or health insurance coverage are deemed to 

7 be incorporated into, and made a part of, such plan or 

8 the policy, certificate, or contract providing such coverage 

9 and are enforceable under law as if directly included in 

10 the documentation of such plan or such policy, certificate, 

11 or contract. 

12 SEC. 157. PRESERVATION OF PROTECTIONS. 

13 (a) IN GENERAL.—The rights under this Act (includ14 ing the right to maintain a civil action and any other 

15 rights under the amendments made by this Act) may not 

16 be waived, deferred, or lost pursuant to any agreement 

17 not authorized under this Act (or such amendments). 

18 (b) EXCEPTION.—Subsection (a) shall not apply to 

19 an agreement providing for arbitration or participation in 

20 any other nonjudicial procedure to resolve a dispute if the 

21 agreement is entered into knowingly and voluntarily by the 

22 parties involved after the dispute has arisen or is pursuant 

23 to the terms of a collective bargaining agreement. Nothing 

24 in this subsection shall be construed to permit the waiver 

25 of the requirements of sections 503B and 503C of the Em-
146

•S 1945 IS 

1 ployee Retirement Income Security Act of 1974 (relating 

2 to internal and external review). 

3 TITLE II—APPLICATION OF 

4 QUALITY CARE STANDARDS 

5 TO GROUP HEALTH PLANS 

6 AND HEALTH INSURANCE 

7 COVERAGE UNDER THE PUB8 LIC HEALTH SERVICE ACT 

9 SEC. 201. APPLICATION TO GROUP HEALTH PLANS AND 

10 GROUP HEALTH INSURANCE COVERAGE. 

11 (a) IN GENERAL.—Subpart 2 of part A of title 

12 XXVII of the Public Health Service Act is amended by 

13 adding at the end the following new section: 

14 ‘‘SEC. 2707. PATIENT PROTECTION STANDARDS. 

15 ‘‘Each group health plan shall comply with patient 

16 protection requirements under title I of the Bipartisan Pa17 tient Protection Act, and each health insurance issuer 

18 shall comply with patient protection requirements under 

19 such title with respect to group health insurance coverage 

20 it offers, and such requirements shall be deemed to be in21 corporated into this subsection.’’. 

22 (b) CONFORMING AMENDMENT.—Section 

23 2721(b)(2)(A) of such Act (42 U.S.C. 300gg–21(b)(2)(A)) 

24 is amended by inserting ‘‘(other than section 2707)’’ after 

25 ‘‘requirements of such subparts’’. 
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•S 1945 IS 

1 SEC. 202. APPLICATION TO INDIVIDUAL HEALTH INSUR2 ANCE COVERAGE. 

3 Part B of title XXVII of the Public Health Service 

4 Act is amended by inserting after section 2752 the fol5 lowing new section: 

6 ‘‘SEC. 2753. PATIENT PROTECTION STANDARDS. 

7 ‘‘Each health insurance issuer shall comply with pa8 tient protection requirements under title I of the Bipar9 tisan Patient Protection Act with respect to individual 

10 health insurance coverage it offers, and such requirements 

11 shall be deemed to be incorporated into this subsection.’’. 

12 SEC. 203. COOPERATION BETWEEN FEDERAL AND STATE 

13 AUTHORITIES. 

14 Part C of title XXVII of the Public Health Service 

15 Act (42 U.S.C. 300gg–91 et seq.) is amended by adding 

16 at the end the following: 

17 ‘‘SEC. 2793. COOPERATION BETWEEN FEDERAL AND STATE 

18 AUTHORITIES. 

19 ‘‘(a) AGREEMENT WITH STATES.—A State may 

20 enter into an agreement with the Secretary for the delega21 tion to the State of some or all of the Secretary’s authority 

22 under this title to enforce the requirements applicable 

23 under title I of the Bipartisan Patient Protection Act with 

24 respect to health insurance coverage offered by a health 

25 insurance issuer and with respect to a group health plan 

26 that is a non-Federal governmental plan.
148

•S 1945 IS 

1 ‘‘(b) DELEGATIONS.—Any department, agency, or in2 strumentality of a State to which authority is delegated 

3 pursuant to an agreement entered into under this section 

4 may, if authorized under State law and to the extent con5 sistent with such agreement, exercise the powers of the 

6 Secretary under this title which relate to such authority.’’. 

7 TITLE III—APPLICATION OF PA8 TIENT PROTECTION STAND9 ARDS TO FEDERAL HEALTH 

10 CARE PROGRAMS 

11 SEC. 301. APPLICATION OF PATIENT PROTECTION STAND12 ARDS TO FEDERAL HEALTH CARE PRO13 GRAMS. 

14 (a) APPLICATION OF STANDARDS.—

15 (1) IN GENERAL.—Each Federal health care 

16 program shall comply with the patient protection re17 quirements under title I, and such requirements 

18 shall be deemed to be incorporated into this section. 

19 (2) CAUSE OF ACTION RELATING TO PROVISION

20 OF HEALTH BENEFITS.—Any individual who receives 

21 a health care item or service under a Federal health 

22 care program shall have a cause of action against 

23 the Federal Government under sections 502(n) and 

24 514(d) of the Employee Retirement Income Security 
149

•S 1945 IS 

1 Act of 1974, and the provisions of such sections 

2 shall be deemed to be incorporated into this section. 

3 (3) RULES OF CONSTRUCTION.—For purposes 

4 of this subsection—

5 (A) each Federal health care program shall 

6 be deemed to be a group health plan; 

7 (B) the Federal Government shall be 

8 deemed to be the plan sponsor of each Federal 

9 health care program; and 

10 (C) each individual eligible for benefits 

11 under a Federal health care program shall be 

12 deemed to be a participant, beneficiary, or en13 rollee under that program. 

14 (b) FEDERAL HEALTH CARE PROGRAM DEFINED.—

15 In this section, the term ‘‘Federal health care program’’ 

16 has the meaning given that term under section 1128B(f) 

17 of the Social Security Act (42 U.S.C. 1320a–7b) except 

18 that, for purposes of this section, such term includes the 

19 Federal employees health benefits program established 

20 under chapter 89 of title 5, United States Code. 
150

•S 1945 IS 

1 TITLE IV—AMENDMENTS TO THE 

2 EMPLOYEE RETIREMENT IN3 COME SECURITY ACT OF 1974

4 SEC. 401. APPLICATION OF PATIENT PROTECTION STAND5 ARDS TO GROUP HEALTH PLANS AND GROUP 

6 HEALTH INSURANCE COVERAGE UNDER THE 

7 EMPLOYEE RETIREMENT INCOME SECURITY 

8 ACT OF 1974. 

9 Subpart B of part 7 of subtitle B of title I of the 

10 Employee Retirement Income Security Act of 1974 is 

11 amended by adding at the end the following new section: 

12 ‘‘SEC. 714. PATIENT PROTECTION STANDARDS. 

13 ‘‘(a) IN GENERAL.—Subject to subsection (b), a 

14 group health plan (and a health insurance issuer offering 

15 group health insurance coverage in connection with such 

16 a plan) shall comply with the requirements of title I of 

17 the Bipartisan Patient Protection Act (as in effect as of 

18 the date of the enactment of such Act), and such require19 ments shall be deemed to be incorporated into this sub20 section. 

21 ‘‘(b) PLAN SATISFACTION OF CERTAIN REQUIRE22 MENTS.—

23 ‘‘(1) SATISFACTION OF CERTAIN REQUIRE24 MENTS THROUGH INSURANCE.—For purposes of 

25 subsection (a), insofar as a group health plan pro-
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•S 1945 IS 

1 vides benefits in the form of health insurance cov2 erage through a health insurance issuer, the plan 

3 shall be treated as meeting the following require4 ments of title I of the Bipartisan Patient Protection 

5 Act with respect to such benefits and not be consid6 ered as failing to meet such requirements because of 

7 a failure of the issuer to meet such requirements so 

8 long as the plan sponsor or its representatives did 

9 not cause such failure by the issuer: 

10 ‘‘(A) Section 111 (relating to consumer 

11 choice option). 

12 ‘‘(B) Section 112 (relating to choice of 

13 health care professional). 

14 ‘‘(C) Section 113 (relating to access to 

15 emergency care). 

16 ‘‘(D) Section 114 (relating to timely access 

17 to specialists). 

18 ‘‘(E) Section 115 (relating to patient ac19 cess to obstetrical and gynecological care). 

20 ‘‘(F) Section 116 (relating to access to pe21 diatric care). 

22 ‘‘(G) Section 117 (relating to continuity of 

23 care), but only insofar as a replacement issuer 

24 assumes the obligation for continuity of care. 
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1 ‘‘(H) Section 118 (relating to access to 

2 needed prescription drugs). 

3 ‘‘(I) Section 119 (relating to coverage for 

4 individuals participating in approved clinical 

5 trials). 

6 ‘‘(J) Section 120 (relating to required cov7 erage for minimum hospital stay for 

8 mastectomies and lymph node dissections for 

9 the treatment of breast cancer and coverage for 

10 secondary consultations). 

11 ‘‘(K) Section 134 (relating to payment of 

12 claims). 

13 ‘‘(2) INFORMATION.—With respect to informa14 tion required to be provided or made available under 

15 section 121 of the Bipartisan Patient Protection 

16 Act, in the case of a group health plan that provides 

17 benefits in the form of health insurance coverage 

18 through a health insurance issuer, the Secretary 

19 shall determine the circumstances under which the 

20 plan is not required to provide or make available the 

21 information (and is not liable for the issuer’s failure 

22 to provide or make available the information), if the 

23 issuer is obligated to provide and make available (or 

24 provides and makes available) such information.
153

•S 1945 IS 

1 ‘‘(3) INTERNAL APPEALS.—With respect to the 

2 internal appeals process required to be established 

3 under section 103 of such Act, in the case of a 

4 group health plan that provides benefits in the form 

5 of health insurance coverage through a health insur6 ance issuer, the Secretary shall determine the cir7 cumstances under which the plan is not required to 

8 provide for such process and system (and is not lia9 ble for the issuer’s failure to provide for such proc10 ess and system), if the issuer is obligated to provide 

11 for (and provides for) such process and system. 

12 ‘‘(4) EXTERNAL APPEALS.—Pursuant to rules 

13 of the Secretary, insofar as a group health plan en14 ters into a contract with a qualified external appeal 

15 entity for the conduct of external appeal activities in 

16 accordance with section 104 of such Act, the plan 

17 shall be treated as meeting the requirement of such 

18 section and is not liable for the entity’s failure to 

19 meet any requirements under such section. 

20 ‘‘(5) APPLICATION TO PROHIBITIONS.—Pursu21 ant to rules of the Secretary, if a health insurance 

22 issuer offers health insurance coverage in connection 

23 with a group health plan and takes an action in vio24 lation of any of the following sections of the Bipar25 tisan Patient Protection Act, the group health plan 
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•S 1945 IS 

1 shall not be liable for such violation unless the plan 

2 caused such violation: 

3 ‘‘(A) Section 131 (relating to prohibition of 

4 interference with certain medical communica5 tions). 

6 ‘‘(B) Section 132 (relating to prohibition 

7 of discrimination against providers based on li8 censure). 

9 ‘‘(C) Section 133 (relating to prohibition 

10 against improper incentive arrangements). 

11 ‘‘(D) Section 135 (relating to protection 

12 for patient advocacy). 

13 ‘‘(6) CONSTRUCTION.—Nothing in this sub14 section shall be construed to affect or modify the re15 sponsibilities of the fiduciaries of a group health 

16 plan under part 4 of subtitle B. 

17 ‘‘(7) TREATMENT OF SUBSTANTIALLY COMPLI18 ANT STATE LAWS.—For purposes of applying this 

19 subsection, any reference in this subsection to a re20 quirement in a section or other provision in the Bi21 partisan Patient Protection Act with respect to a 

22 health insurance issuer is deemed to include a ref23 erence to a requirement under a State law that sub24 stantially complies (as determined under section 
155

•S 1945 IS 

1 152(c) of such Act) with the requirement in such 

2 section or other provisions. 

3 ‘‘(8) APPLICATION TO CERTAIN PROHIBITIONS

4 AGAINST RETALIATION.—With respect to compliance 

5 with the requirements of section 135(b)(1) of the Bi6 partisan Patient Protection Act, for purposes of this 

7 subtitle the term ‘group health plan’ is deemed to in8 clude a reference to an institutional health care pro9 vider. 

10 ‘‘(c) ENFORCEMENT OF CERTAIN REQUIREMENTS.—

11 ‘‘(1) COMPLAINTS.—Any protected health care 

12 professional who believes that the professional has 

13 been retaliated or discriminated against in violation 

14 of section 135(b)(1) of the Bipartisan Patient Pro15 tection Act may file with the Secretary a complaint 

16 within 180 days of the date of the alleged retaliation 

17 or discrimination. 

18 ‘‘(2) INVESTIGATION.—The Secretary shall in19 vestigate such complaints and shall determine if a 

20 violation of such section has occurred and, if so, 

21 shall issue an order to ensure that the protected 

22 health care professional does not suffer any loss of 

23 position, pay, or benefits in relation to the plan, 

24 issuer, or provider involved, as a result of the viola25 tion found by the Secretary. 
156

•S 1945 IS 

1 ‘‘(d) CONFORMING REGULATIONS.—The Secretary 

2 shall issue regulations to coordinate the requirements on 

3 group health plans and health insurance issuers under this 

4 section with the requirements imposed under the other 

5 provisions of this title. In order to reduce duplication and 

6 clarify the rights of participants and beneficiaries with re7 spect to information that is required to be provided, such 

8 regulations shall coordinate the information disclosure re9 quirements under section 121 of the Bipartisan Patient 

10 Protection Act with the reporting and disclosure require11 ments imposed under part 1, so long as such coordination 

12 does not result in any reduction in the information that 

13 would otherwise be provided to participants and bene14 ficiaries.’’. 

15 (b) SATISFACTION OF ERISA CLAIMS PROCEDURE

16 REQUIREMENT.—Section 503 of such Act (29 U.S.C. 

17 1133) is amended by inserting ‘‘(a)’’ after ‘‘SEC. 503.’’ 

18 and by adding at the end the following new subsection: 

19 ‘‘(b) In the case of a group health plan (as defined 

20 in section 733) compliance with the requirements of sub21 title A of title I of the Bipartisan Patient Protection Act, 

22 and compliance with regulations promulgated by the Sec23 retary, in the case of a claims denial shall be deemed com24 pliance with subsection (a) with respect to such claims de25 nial.’’. 
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•S 1945 IS 

1 (c) CONFORMING AMENDMENTS.—(1) Section 732(a) 

2 of such Act (29 U.S.C. 1185(a)) is amended by striking 

3 ‘‘section 711’’ and inserting ‘‘sections 711 and 714’’. 

4 (2) The table of contents in section 1 of such Act 

5 is amended by inserting after the item relating to section 

6 713 the following new item:

‘‘Sec. 714. Patient protection standards.’’.

7 (3) Section 502(b)(3) of such Act (29 U.S.C. 

8 1132(b)(3)) is amended by inserting ‘‘(other than section 

9 135(b))’’ after ‘‘part 7’’. 

10 SEC. 402. AVAILABILITY OF CIVIL REMEDIES. 

11 (a) AVAILABILITY OF FEDERAL CIVIL REMEDIES IN

12 CASES NOT INVOLVING MEDICALLY REVIEWABLE DECI13 SIONS.—

14 (1) IN GENERAL.—Section 502 of the Employee 

15 Retirement Income Security Act of 1974 (29 U.S.C. 

16 1132) is amended by adding at the end the following 

17 new subsections: 

18 ‘‘(n) CAUSE OF ACTION RELATING TO PROVISION OF

19 HEALTH BENEFITS.—

20 ‘‘(1) IN GENERAL.—In any case in which—

21 ‘‘(A) a person who is a fiduciary of a 

22 group health plan, a health insurance issuer of23 fering health insurance coverage in connection 

24 with the plan, or an agent of the plan, issuer, 

25 or plan sponsor upon consideration of a claim
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•S 1945 IS 

1 for benefits of a participant or beneficiary 

2 under section 102 of the Bipartisan Patient 

3 Protection Act (relating to procedures for initial 

4 claims for benefits and prior authorization de5 terminations) or upon review of a denial of such 

6 a claim under section 103 of such Act (relating 

7 to internal appeal of a denial of a claim for ben8 efits), fails to exercise ordinary care in making 

9 a decision—

10 ‘‘(i) regarding whether an item or 

11 service is covered under the terms and con12 ditions of the plan or coverage, 

13 ‘‘(ii) regarding whether an individual 

14 is a participant or beneficiary who is en15 rolled under the terms and conditions of 

16 the plan or coverage (including the applica17 bility of any waiting period under the plan 

18 or coverage), or 

19 ‘‘(iii) as to the application of cost20 sharing requirements or the application of 

21 a specific exclusion or express limitation on 

22 the amount, duration, or scope of coverage 

23 of items or services under the terms and 

24 conditions of the plan or coverage, and 
159

•S 1945 IS 

1 ‘‘(B) such failure is a proximate cause of 

2 personal injury to, or the death of, the partici3 pant or beneficiary, 

4 such plan, plan sponsor or issuer shall be liable to 

5 the participant or beneficiary (or the estate of such 

6 participant or beneficiary) for economic and non7 economic damages (but not exemplary or punitive 

8 damages) in connection with such personal injury or 

9 death. 

10 ‘‘(2) CAUSE OF ACTION MUST NOT INVOLVE

11 MEDICALLY REVIEWABLE DECISION.—

12 ‘‘(A) IN GENERAL.—A cause of action is 

13 established under paragraph (1)(A) only if the 

14 decision referred to in paragraph (1)(A) does 

15 not include a medically reviewable decision. 

16 ‘‘(B) MEDICALLY REVIEWABLE DECI17 SION.—For purposes of this subsection, the 

18 term ‘medically reviewable decision’ means a de19 nial of a claim for benefits under the plan 

20 which is described in section 104(d)(2) of the 

21 Bipartisan Patient Protection Act (relating to 

22 medically reviewable decisions). 

23 ‘‘(3) LIMITATION REGARDING CERTAIN TYPES

24 OF ACTIONS SAVED FROM PREEMPTION OF STATE

25 LAW.—A cause of action is not established under 
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•S 1945 IS 

1 paragraph (1)(A) in connection with a failure de2 scribed in paragraph (1)(A) to the extent that a 

3 cause of action under State law (as defined in sec4 tion 514(c)) for such failure would not be preempted 

5 under section 514. 

6 ‘‘(4) DEFINITIONS.—For purposes of this sub7 section.—

8 ‘‘(A) ORDINARY CARE.—The term ‘ordi9 nary care’ means, with respect to a determina10 tion on a claim for benefits, that degree of care, 

11 skill, and diligence that a reasonable and pru12 dent individual would exercise in making a fair 

13 determination on a claim for benefits of like 

14 kind to the claims involved. 

15 ‘‘(B) PERSONAL INJURY.—The term ‘per16 sonal injury’ means a physical injury and in17 cludes an injury arising out of the treatment 

18 (or failure to treat) a mental illness or disease. 

19 ‘‘(C) CLAIM FOR BENEFITS; DENIAL.—The 

20 terms ‘claim for benefits’ and ‘denial of a claim 

21 for benefits’ have the meanings provided such 

22 terms in section 102(e) of the Bipartisan Pa23 tient Protection Act. 

24 ‘‘(D) TERMS AND CONDITIONS.—The term 

25 ‘terms and conditions’ includes, with respect to 
161

•S 1945 IS 

1 a group health plan or health insurance cov2 erage, requirements imposed under title I of the 

3 Bipartisan Patient Protection Act. 

4 ‘‘(E) GROUP HEALTH PLAN AND OTHER

5 RELATED TERMS.—The provisions of sections 

6 732(d) and 733 apply for purposes of this sub7 section in the same manner as they apply for 

8 purposes of part 7, except that the term ‘group 

9 health plan’ includes a group health plan (as 

10 defined in section 607(1)). 

11 ‘‘(5) EXCLUSION OF EMPLOYERS AND OTHER

12 PLAN SPONSORS.—

13 ‘‘(A) CAUSES OF ACTION AGAINST EM14 PLOYERS AND PLAN SPONSORS PRECLUDED.—

15 Subject to subparagraph (B), paragraph (1)(A) 

16 does not authorize a cause of action against an 

17 employer or other plan sponsor maintaining the 

18 plan (or against an employee of such an em19 ployer or sponsor acting within the scope of em20 ployment). 

21 ‘‘(B) CERTAIN CAUSES OF ACTION PER22 MITTED.—Notwithstanding subparagraph (A), 

23 a cause of action may arise against an employer 

24 or other plan sponsor (or against an employee 

25 of such an employer or sponsor acting within 
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•S 1945 IS 

1 the scope of employment) under paragraph 

2 (1)(A), to the extent there was direct participa3 tion by the employer or other plan sponsor (or 

4 employee) in the decision of the plan under sec5 tion 102 of the Bipartisan Patient Protection 

6 Act upon consideration of a claim for benefits 

7 or under section 103 of such Act upon review 

8 of a denial of a claim for benefits. 

9 ‘‘(C) DIRECT PARTICIPATION.—

10 ‘‘(i) IN GENERAL.—For purposes of 

11 subparagraph (B), the term ‘direct partici12 pation’ means, in connection with a deci13 sion described in paragraph (1)(A), the ac14 tual making of such decision or the actual 

15 exercise of control in making such decision. 

16 ‘‘(ii) RULES OF CONSTRUCTION.—For 

17 purposes of clause (i), the employer or plan 

18 sponsor (or employee) shall not be con19 strued to be engaged in direct participation 

20 because of any form of decisionmaking or 

21 other conduct that is merely collateral or 

22 precedent to the decision described in 

23 paragraph (1)(A) on a particular claim for 

24 benefits of a participant or beneficiary, in25 cluding (but not limited to)—
163

•S 1945 IS 

1 ‘‘(I) any participation by the em2 ployer or other plan sponsor (or em3 ployee) in the selection of the group 

4 health plan or health insurance cov5 erage involved or the third party ad6 ministrator or other agent; 

7 ‘‘(II) any engagement by the em8 ployer or other plan sponsor (or em9 ployee) in any cost-benefit analysis 

10 undertaken in connection with the se11 lection of, or continued maintenance 

12 of, the plan or coverage involved; 

13 ‘‘(III) any participation by the 

14 employer or other plan sponsor (or 

15 employee) in the process of creating, 

16 continuing, modifying, or terminating 

17 the plan or any benefit under the 

18 plan, if such process was not substan19 tially focused solely on the particular 

20 situation of the participant or bene21 ficiary referred to in paragraph 

22 (1)(A); and 

23 ‘‘(IV) any participation by the 

24 employer or other plan sponsor (or 

25 employee) in the design of any benefit 
164

•S 1945 IS 

1 under the plan, including the amount 

2 of copayment and limits connected 

3 with such benefit. 

4 ‘‘(iii) IRRELEVANCE OF CERTAIN COL5 LATERAL EFFORTS MADE BY EMPLOYER

6 OR PLAN SPONSOR.—For purposes of this 

7 subparagraph, an employer or plan sponsor 

8 shall not be treated as engaged in direct 

9 participation in a decision with respect to 

10 any claim for benefits or denial thereof in 

11 the case of any particular participant or 

12 beneficiary solely by reason of—

13 ‘‘(I) any efforts that may have 

14 been made by the employer or plan 

15 sponsor to advocate for authorization 

16 of coverage for that or any other par17 ticipant or beneficiary (or any group 

18 of participants or beneficiaries), or 

19 ‘‘(II) any provision that may 

20 have been made by the employer or 

21 plan sponsor for benefits which are 

22 not covered under the terms and con23 ditions of the plan for that or any 

24 other participant or beneficiary (or 
165

•S 1945 IS 

1 any group of participants or bene2 ficiaries). 

3 ‘‘(D) APPLICATION TO CERTAIN PLANS.—

4 ‘‘(i) IN GENERAL.—Notwithstanding 

5 any other provision of this subsection, no 

6 group health plan described in clause (ii) 

7 shall be liable under paragraph (1) for the 

8 performance of, or the failure to perform, 

9 any non-medically reviewable duty under 

10 the plan. 

11 ‘‘(ii) DEFINITION.—A group health 

12 plan described in this clause is—

13 ‘‘(I) a group health plan that is 

14 self-insured and self administered by 

15 an employer (including an employee of 

16 such an employer acting within the 

17 scope of employment); or 

18 ‘‘(II) a multiemployer plan as de19 fined in section 3(37)(A) (including 

20 an employee of a contributing em21 ployer or of the plan, or a fiduciary of 

22 the plan, acting within the scope of 

23 employment or fiduciary responsi24 bility) that is self-insured and self-ad25 ministered. 
166

•S 1945 IS 

1 ‘‘(6) EXCLUSION OF PHYSICIANS AND OTHER

2 HEALTH CARE PROFESSIONALS.—

3 ‘‘(A) IN GENERAL.—No treating physician 

4 or other treating health care professional of the 

5 participant or beneficiary, and no person acting 

6 under the direction of such a physician or 

7 health care professional, shall be liable under 

8 paragraph (1) for the performance of, or the 

9 failure to perform, any non-medically reviewable 

10 duty of the plan, the plan sponsor, or any 

11 health insurance issuer offering health insur12 ance coverage in connection with the plan. 

13 ‘‘(B) DEFINITIONS.—For purposes of sub14 paragraph (A)—

15 ‘‘(i) HEALTH CARE PROFESSIONAL.—

16 The term ‘health care professional’ means 

17 an individual who is licensed, accredited, or 

18 certified under State law to provide speci19 fied health care services and who is oper20 ating within the scope of such licensure, 

21 accreditation, or certification. 

22 ‘‘(ii) NON-MEDICALLY REVIEWABLE

23 DUTY.—The term ‘non-medically review24 able duty’ means a duty the discharge of 
167

•S 1945 IS 

1 which does not include the making of a 

2 medically reviewable decision. 

3 ‘‘(7) EXCLUSION OF HOSPITALS.—No treating 

4 hospital of the participant or beneficiary shall be lia5 ble under paragraph (1) for the performance of, or 

6 the failure to perform, any non-medically reviewable 

7 duty (as defined in paragraph (6)(B)(ii)) of the 

8 plan, the plan sponsor, or any health insurance 

9 issuer offering health insurance coverage in connec10 tion with the plan. 

11 ‘‘(8) RULE OF CONSTRUCTION RELATING TO

12 EXCLUSION FROM LIABILITY OF PHYSICIANS, 

13 HEALTH CARE PROFESSIONALS, AND HOSPITALS.—

14 Nothing in paragraph (6) or (7) shall be construed 

15 to limit the liability (whether direct or vicarious) of 

16 the plan, the plan sponsor, or any health insurance 

17 issuer offering health insurance coverage in connec18 tion with the plan. 

19 ‘‘(9) REQUIREMENT OF EXHAUSTION.—

20 ‘‘(A) IN GENERAL.—A cause of action may 

21 not be brought under paragraph (1) in connec22 tion with any denial of a claim for benefits of 

23 any individual until all administrative processes 

24 under sections 102 and 103 of the Bipartisan 
168

•S 1945 IS 

1 Patient Protection Act (if applicable) have been 

2 exhausted. 

3 ‘‘(B) EXCEPTION FOR NEEDED CARE.—A 

4 participant or beneficiary may seek relief exclu5 sively in Federal court under subsection 

6 502(a)(1)(B) prior to the exhaustion of admin7 istrative remedies under sections 102, 103, or 

8 104 of the Bipartisan Patient Protection Act 

9 (as required under subparagraph (A)) if it is 

10 demonstrated to the court that the exhaustion 

11 of such remedies would cause irreparable harm 

12 to the health of the participant or beneficiary. 

13 Notwithstanding the awarding of relief under 

14 subsection 502(a)(1)(B) pursuant to this sub15 paragraph, no relief shall be available as a re16 sult of, or arising under, paragraph (1)(A) or 

17 paragraph (10)(B), with respect to a partici18 pant or beneficiary, unless the requirements of 

19 subparagraph (A) are met. 

20 ‘‘(C) RECEIPT OF BENEFITS DURING AP21 PEALS PROCESS.—Receipt by the participant or 

22 beneficiary of the benefits involved in the claim 

23 for benefits during the pendency of any admin24 istrative processes referred to in subparagraph
169

•S 1945 IS 

1 (A) or of any action commenced under this sub2 section—

3 ‘‘(i) shall not preclude continuation of 

4 all such administrative processes to their 

5 conclusion if so moved by any party, and 

6 ‘‘(ii) shall not preclude any liability 

7 under subsection (a)(1)(C) and this sub8 section in connection with such claim. 

9 The court in any action commenced under this 

10 subsection shall take into account any receipt of 

11 benefits during such administrative processes or 

12 such action in determining the amount of the 

13 damages awarded. 

14 ‘‘(D) ADMISSIBLE.—Any determination 

15 made by a reviewer in an administrative pro16 ceeding under section 103 of the Bipartisan Pa17 tient Protection Act shall be admissible in any 

18 Federal court proceeding and shall be presented 

19 to the trier of fact. 

20 ‘‘(10) STATUTORY DAMAGES.—

21 ‘‘(A) IN GENERAL.—The remedies set 

22 forth in this subsection (n) shall be the exclu23 sive remedies for causes of action brought 

24 under this subsection. 
170

•S 1945 IS 

1 ‘‘(B) ASSESSMENT OF CIVIL PENALTIES.—

2 In addition to the remedies provided for in 

3 paragraph (1) (relating to the failure to provide 

4 contract benefits in accordance with the plan), 

5 a civil assessment, in an amount not to exceed 

6 $5,000,000, payable to the claimant may be 

7 awarded in any action under such paragraph if 

8 the claimant establishes by clear and convincing 

9 evidence that the alleged conduct carried out by 

10 the defendant demonstrated bad faith and fla11 grant disregard for the rights of the participant 

12 or beneficiary under the plan and was a proxi13 mate cause of the personal injury or death that 

14 is the subject of the claim. 

15 ‘‘(11) LIMITATION ON ATTORNEYS’ FEES.—

16 ‘‘(A) IN GENERAL.—Notwithstanding any 

17 other provision of law, or any arrangement, 

18 agreement, or contract regarding an attorney’s 

19 fee, the amount of an attorney’s contingency fee 

20 allowable for a cause of action brought pursuant to this subsection shall not exceed 1 21 ⁄3 of the 

22 total amount of the plaintiff’s recovery (not in23 cluding the reimbursement of actual out-of24 pocket expenses of the attorney). 
171

•S 1945 IS 

1 ‘‘(B) DETERMINATION BY DISTRICT

2 COURT.—The last Federal district court in 

3 which the action was pending upon the final 

4 disposition, including all appeals, of the action 

5 shall have jurisdiction to review the attorney’s 

6 fee to ensure that the fee is a reasonable one. 

7 ‘‘(12) LIMITATION OF ACTION.—Paragraph (1) 

8 shall not apply in connection with any action com9 menced after 3 years after the later of—

10 ‘‘(A) the date on which the plaintiff first 

11 knew, or reasonably should have known, of the 

12 personal injury or death resulting from the fail13 ure described in paragraph (1), or 

14 ‘‘(B) the date as of which the requirements 

15 of paragraph (9) are first met. 

16 ‘‘(13) TOLLING PROVISION.—The statute of 

17 limitations for any cause of action arising under 

18 State law relating to a denial of a claim for benefits 

19 that is the subject of an action brought in Federal 

20 court under this subsection shall be tolled until such 

21 time as the Federal court makes a final disposition, 

22 including all appeals, of whether such claim should 

23 properly be within the jurisdiction of the Federal 

24 court. The tolling period shall be determined by the 
172

•S 1945 IS 

1 applicable Federal or State law, whichever period is 

2 greater. 

3 ‘‘(14) PURCHASE OF INSURANCE TO COVER LI4 ABILITY.—Nothing in section 410 shall be construed 

5 to preclude the purchase by a group health plan of 

6 insurance to cover any liability or losses arising 

7 under a cause of action under subsection (a)(1)(C) 

8 and this subsection. 

9 ‘‘(15) EXCLUSION OF DIRECTED RECORD10 KEEPERS.—

11 ‘‘(A) IN GENERAL.—Subject to subpara12 graph (C), paragraph (1) shall not apply with 

13 respect to a directed recordkeeper in connection 

14 with a group health plan. 

15 ‘‘(B) DIRECTED RECORDKEEPER.—For 

16 purposes of this paragraph, the term ‘directed 

17 recordkeeper’ means, in connection with a 

18 group health plan, a person engaged in directed 

19 recordkeeping activities pursuant to the specific 

20 instructions of the plan or the employer or 

21 other plan sponsor, including the distribution of 

22 enrollment information and distribution of dis23 closure materials under this Act or title I of the 

24 Bipartisan Patient Protection Act and whose 
173

•S 1945 IS 

1 duties do not include making decisions on 

2 claims for benefits. 

3 ‘‘(C) LIMITATION.—Subparagraph (A) 

4 does not apply in connection with any directed 

5 recordkeeper to the extent that the directed rec6 ordkeeper fails to follow the specific instruction 

7 of the plan or the employer or other plan spon8 sor. 

9 ‘‘(16) EXCLUSION OF HEALTH INSURANCE

10 AGENTS.—Paragraph (1) does not apply with re11 spect to a person whose sole involvement with the 

12 group health plan is providing advice or administra13 tive services to the employer or other plan sponsor 

14 relating to the selection of health insurance coverage 

15 offered in connection with the plan. 

16 ‘‘(17) NO EFFECT ON STATE LAW.—No provi17 sion of State law (as defined in section 514(c)(1)) 

18 shall be treated as superseded or otherwise altered, 

19 amended, modified, invalidated, or impaired by rea20 son of the provisions of subsection (a)(1)(C) and this 

21 subsection. 

22 ‘‘(18) RELIEF FROM LIABILITY FOR EMPLOYER

23 OR OTHER PLAN SPONSOR BY MEANS OF DES24 IGNATED DECISIONMAKER.—
174

•S 1945 IS 

1 ‘‘(A) IN GENERAL.—Notwithstanding the 

2 direct participation (as defined in paragraph 

3 (5)(C)(i)) of an employer or plan sponsor, in 

4 any case in which there is deemed to be a des5 ignated decisionmaker under subparagraph (B) 

6 that meets the requirements of subsection 

7 (o)(1) for an employer or other plan sponsor—

8 ‘‘(i) all liability of such employer or 

9 plan sponsor (and any employee thereof 

10 acting within the scope of employment) 

11 under this subsection in connection with 

12 any participant or beneficiary shall be 

13 transferred to, and assumed by, the des14 ignated decisionmaker, and 

15 ‘‘(ii) with respect to such liability, the 

16 designated decisionmaker shall be sub17 stituted for the employer or plan sponsor 

18 (or employee) in the action and may not 

19 raise any defense that the employer or plan 

20 sponsor (or employee) could not raise if 

21 such a decisionmaker were not so deemed. 

22 ‘‘(B) AUTOMATIC DESIGNATION.—A health 

23 insurance issuer shall be deemed to be a des24 ignated decisionmaker for purposes of subpara25 graph (A) with respect to the participants and 
175

•S 1945 IS 

1 beneficiaries of an employer or plan sponsor, 

2 whether or not the employer or plan sponsor 

3 makes such a designation, and shall be deemed 

4 to have assumed unconditionally all liability of 

5 the employer or plan sponsor under such des6 ignation in accordance with subsection (o), un7 less the employer or plan sponsor affirmatively 

8 enters into a contract to prevent the service of 

9 the designated decisionmaker. 

10 ‘‘(19) PREVIOUSLY PROVIDED SERVICES.—

11 ‘‘(A) IN GENERAL.—Except as provided in 

12 this paragraph, a cause of action shall not arise 

13 under paragraph (1) where the denial involved 

14 relates to an item or service that has already 

15 been fully provided to the participant or bene16 ficiary under the plan or coverage and the claim 

17 relates solely to the subsequent denial of pay18 ment for the provision of such item or service. 

19 ‘‘(B) EXCEPTION.—Nothing in subpara20 graph (A) shall be construed to—

21 ‘‘(i) prohibit a cause of action under 

22 paragraph (1) where the nonpayment in23 volved results in the participant or bene24 ficiary being unable to receive further 

25 items or services that are directly related 
176

•S 1945 IS 

1 to the item or service involved in the denial 

2 referred to in subparagraph (A) or that 

3 are part of a continuing treatment or se4 ries of procedures; 

5 ‘‘(ii) prohibit a cause of action under 

6 paragraph (1) relating to quality of care; 

7 or 

8 ‘‘(iii) limit liability that otherwise 

9 would arise from the provision of the item 

10 or services or the performance of a medical 

11 procedure. 

12 ‘‘(20) EXEMPTION FROM PERSONAL LIABILITY

13 FOR INDIVIDUAL MEMBERS OF BOARDS OF DIREC14 TORS, JOINT BOARDS OF TRUSTEES, ETC.—Any indi15 vidual who is—

16 ‘‘(A) a member of a board of directors of 

17 an employer or plan sponsor; or 

18 ‘‘(B) a member of an association, com19 mittee, employee organization, joint board of 

20 trustees, or other similar group of representa21 tives of the entities that are the plan sponsor 

22 of plan maintained by two or more employers 

23 and one or more employee organizations; 

24 shall not be personally liable under this subsection 

25 for conduct that is within the scope of employment 
177

•S 1945 IS 

1 of the individuals unless the individual acts in a 

2 fraudulent manner for personal enrichment. 

3 ‘‘(o) REQUIREMENTS FOR DESIGNATED DECISION4 MAKERS OF GROUP HEALTH

5 ‘‘(1) IN GENERAL.—For purposes of subsection 

6 (n)(18) and section 514(d)(9), a designated decision7 maker meets the requirements of this paragraph 

8 with respect to any participant or beneficiary if—

9 ‘‘(A) such designation is in such form as 

10 may be prescribed in regulations of the Sec11 retary, 

12 ‘‘(B) the designated decisionmaker—

13 ‘‘(i) meets the requirements of para14 graph (2), 

15 ‘‘(ii) assumes unconditionally all liabil16 ity of the employer or plan sponsor in17 volved (and any employee thereof acting 

18 within the scope of employment) either 

19 arising under subsection (n) or arising in 

20 a cause of action permitted under section 

21 514(d) in connection with actions (and 

22 failures to act) of the employer or plan 

23 sponsor (or employee) occurring during the 

24 period in which the designation under sub25 section (n)(18) or section 514(d)(9) is in 
178

•S 1945 IS 

1 effect relating to such participant and ben2 eficiary, 

3 ‘‘(iii) agrees to be substituted for the 

4 employer or plan sponsor (or employee) in 

5 the action and not to raise any defense 

6 with respect to such liability that the em7 ployer or plan sponsor (or employee) may 

8 not raise, and 

9 ‘‘(iv) where paragraph (2)(B) applies, 

10 assumes unconditionally the exclusive au11 thority under the group health plan to 

12 make medically reviewable decisions under 

13 the plan with respect to such participant 

14 or beneficiary, and 

15 ‘‘(C) the designated decisionmaker and the 

16 participants and beneficiaries for whom the de17 cisionmaker has assumed liability are identified 

18 in the written instrument required under sec19 tion 402(a) and as required under section 

20 121(b)(19) of the Bipartisan Patient Protection 

21 Act. 

22 Any liability assumed by a designated decisionmaker 

23 pursuant to this subsection shall be in addition to 

24 any liability that it may otherwise have under appli25 cable law.
179

•S 1945 IS 

1 ‘‘(2) QUALIFICATIONS FOR DESIGNATED DECI2 SIONMAKERS.—

3 ‘‘(A) IN GENERAL.—Subject to subpara4 graph (B), an entity is qualified under this 

5 paragraph to serve as a designated decision6 maker with respect to a group health plan if the 

7 entity has the ability to assume the liability de8 scribed in paragraph (1) with respect to partici9 pants and beneficiaries under such plan, includ10 ing requirements relating to the financial obli11 gation for timely satisfying the assumed liabil12 ity, and maintains with the plan sponsor and 

13 the Secretary certification of such ability. Such 

14 certification shall be provided to the plan spon15 sor or named fiduciary and to the Secretary 

16 upon designation under subsection (n)(18)(B) 

17 or section 517(d)(9)(B) and not less frequently 

18 than annually thereafter, or if such designation 

19 constitutes a multiyear arrangement, in con20 junction with the renewal of the arrangement. 

21 ‘‘(B) SPECIAL QUALIFICATION IN THE

22 CASE OF CERTAIN REVIEWABLE DECISIONS.—In 

23 the case of a group health plan that provides 

24 benefits consisting of medical care to a partici25 pant or beneficiary only through health insur-
180

•S 1945 IS 

1 ance coverage offered by a single health insur2 ance issue, such issuer is the only entity that 

3 may be qualified under this paragraph to serve 

4 as a designated decisionmaker with respect to 

5 such participant or beneficiary, and shall serve 

6 as the designated decisionmaker unless the em7 ployer or other plan sponsor acts affirmatively 

8 to prevent such service. 

9 ‘‘(3) REQUIREMENTS RELATING TO FINANCIAL

10 OBLIGATIONS.—For purposes of paragraph (2)(A), 

11 the requirements relating to the financial obligation 

12 of an entity for liability shall include—

13 ‘‘(A) coverage of such entity under an in14 surance policy or other arrangement, secured 

15 and maintained by such entity, to effectively in16 sure such entity against losses arising from pro17 fessional liability claims, including those arising 

18 from its service as a designated decisionmaker 

19 under this part; or 

20 ‘‘(B) evidence of minimum capital and sur21 plus levels that are maintained by such entity 

22 to cover any losses as a result of liability arising 

23 from its service as a designated decisionmaker 

24 under this part. 
181

•S 1945 IS 

1 The appropriate amounts of liability insurance and 

2 minimum capital and surplus levels for purposes of 

3 subparagraphs (A) and (B) shall be determined by 

4 an actuary using sound actuarial principles and ac5 counting practices pursuant to established guidelines 

6 of the American Academy of Actuaries and in ac7 cordance with such regulations as the Secretary may 

8 prescribe and shall be maintained throughout the 

9 term for which the designation is in effect. The pro10 visions of this paragraph shall not apply in the case 

11 of a designated decisionmaker that is a group health 

12 plan, plan sponsor, or health insurance issuer and 

13 that is regulated under Federal law or a State finan14 cial solvency law. 

15 ‘‘(4) LIMITATION ON APPOINTMENT OF TREAT16 ING PHYSICIANS.—A treating physician who directly 

17 delivered the care, treatment, or provided the patient 

18 service that is the subject of a cause of action by a 

19 participant or beneficiary under subsection (n) or 

20 section 514(d) may not be designated as a des21 ignated decisionmaker under this subsection with re22 spect to such participant or beneficiary.’’. 

23 (2) CONFORMING AMENDMENT.—Section 

24 502(a)(1) of such Act (29 U.S.C. 1132(a)(1)) is 

25 amended—
182

•S 1945 IS 

1 (A) by striking ‘‘or’’ at the end of subpara2 graph (A); 

3 (B) in subparagraph (B), by striking 

4 ‘‘plan;’’ and inserting ‘‘plan, or’’; and 

5 (C) by adding at the end the following new 

6 subparagraph: 

7 ‘‘(C) for the relief provided for in sub8 section (n) of this section.’’. 

9 (b) RULES RELATING TO ERISA PREEMPTION.—

10 Section 514 of the Employee Retirement Income Security 

11 Act of 1974 (29 U.S.C. 1144) is amended—

12 (1) by redesignating subsection (d) as sub13 section (f); and 

14 (2) by inserting after subsection (c) the fol15 lowing new subsections: 

16 ‘‘(d) PREEMPTION NOT TO APPLY TO CAUSES OF

17 ACTION UNDER STATE LAW INVOLVING MEDICALLY RE18 VIEWABLE DECISION.—

19 ‘‘(1) NON-PREEMPTION OF CERTAIN CAUSES OF

20 ACTION.—

21 ‘‘(A) IN GENERAL.—Except as provided in 

22 this subsection, nothing in this title (including 

23 section 502) shall be construed to supersede or 

24 otherwise alter, amend, modify, invalidate, or 

25 impair any cause of action under State law of 
183

•S 1945 IS 

1 a participant or beneficiary under a group 

2 health plan (or the estate of such a participant 

3 or beneficiary) to recover damages resulting 

4 from personal injury or for wrongful death 

5 against any person if such cause of action 

6 arises by reason of a medically reviewable deci7 sion. 

8 ‘‘(B) MEDICALLY REVIEWABLE DECI9 SION.—For purposes of subparagraph (A), the 

10 term ‘medically reviewable decision’ means a de11 nial of a claim for benefits under the plan 

12 which is described in section 104(d)(2) of the 

13 Bipartisan Patient Protection Act (relating to 

14 medically reviewable decisions). 

15 ‘‘(C) LIMITATION ON PUNITIVE DAM16 AGES.—

17 ‘‘(i) IN GENERAL.—Except as pro18 vided in clauses (ii) and (iii), with respect 

19 to a cause of action described in subpara20 graph (A) brought with respect to a partic21 ipant or beneficiary, State law is super22 seded insofar as it provides any punitive, 

23 exemplary, or similar damages if, as of the 

24 time of the personal injury or death, all 

25 the requirements of the following sections
184

•S 1945 IS 

1 of the Bipartisan Patient Protection Act 

2 were satisfied with respect to the partici3 pant or beneficiary: 

4 ‘‘(I) Section 102 (relating to pro5 cedures for initial claims for benefits 

6 and prior authorization determina7 tions). 

8 ‘‘(II) Section 103 of such Act 

9 (relating to internal appeals of claims 

10 denials). 

11 ‘‘(III) Section 104 of such Act 

12 (relating to independent external ap13 peals procedures). 

14 ‘‘(ii) EXCEPTION FOR CERTAIN AC15 TIONS FOR WRONGFUL DEATH.—Clause (i) 

16 shall not apply with respect to an action 

17 for wrongful death if the applicable State 

18 law provides (or has been construed to pro19 vide) for damages in such an action which 

20 are only punitive or exemplary in nature. 

21 ‘‘(iii) EXCEPTION FOR WILLFUL OR

22 WANTON DISREGARD FOR THE RIGHTS OR

23 SAFETY OF OTHERS.—Clause (i) shall not 

24 apply with respect to any cause of action 

25 described in subparagraph (A) if, in such 
185

•S 1945 IS 

1 action, the plaintiff establishes by clear 

2 and convincing evidence that conduct car3 ried out by the defendant with willful or 

4 wanton disregard for the rights or safety 

5 of others was a proximate cause of the per6 sonal injury or wrongful death that is the 

7 subject of the action. 

8 ‘‘(2) DEFINITIONS.—For purposes of this sub9 section and subsection (e)—

10 ‘‘(A) GROUP HEALTH PLAN AND OTHER

11 RELATED TERMS.—The provisions of sections 

12 732(d) and 733 apply for purposes of this sub13 section in the same manner as they apply for 

14 purposes of part 7, except that the term ‘group 

15 health plan’ includes a group health plan (as 

16 defined in section 607(1)). 

17 ‘‘(B) PERSONAL INJURY.—The term ‘per18 sonal injury’ means a physical injury and in19 cludes an injury arising out of the treatment 

20 (or failure to treat) a mental illness or disease. 

21 ‘‘(C) CLAIM FOR BENEFIT; DENIAL.—The 

22 terms ‘claim for benefits’ and ‘denial of a claim 

23 for benefits’ shall have the meaning provided 

24 such terms under section 102(e) of the Bipar25 tisan Patient Protection Act. 
186

•S 1945 IS 

1 ‘‘(3) EXCLUSION OF EMPLOYERS AND OTHER

2 PLAN SPONSORS.—

3 ‘‘(A) CAUSES OF ACTION AGAINST EM4 PLOYERS AND PLAN SPONSORS PRECLUDED.—

5 Subject to subparagraph (B), paragraph (1) 

6 does not apply with respect to—

7 ‘‘(i) any cause of action against an 

8 employer or other plan sponsor maintain9 ing the plan (or against an employee of 

10 such an employer or sponsor acting within 

11 the scope of employment), or 

12 ‘‘(ii) a right of recovery, indemnity, or 

13 contribution by a person against an em14 ployer or other plan sponsor (or such an 

15 employee) for damages assessed against 

16 the person pursuant to a cause of action to 

17 which paragraph (1) applies. 

18 ‘‘(B) CERTAIN CAUSES OF ACTION PER19 MITTED.—Notwithstanding subparagraph (A), 

20 paragraph (1) applies with respect to any cause 

21 of action that is brought by a participant or 

22 beneficiary under a group health plan (or the 

23 estate of such a participant or beneficiary) to 

24 recover damages resulting from personal injury 

25 or for wrongful death against any employer or 
187

•S 1945 IS 

1 other plan sponsor maintaining the plan (or 

2 against an employee of such an employer or 

3 sponsor acting within the scope of employment) 

4 if such cause of action arises by reason of a 

5 medically reviewable decision, to the extent that 

6 there was direct participation by the employer 

7 or other plan sponsor (or employee) in the deci8 sion. 

9 ‘‘(C) DIRECT PARTICIPATION.—

10 ‘‘(i) DIRECT PARTICIPATION IN DECI11 SIONS.—For purposes of subparagraph 

12 (B), the term ‘direct participation’ means, 

13 in connection with a decision described in 

14 subparagraph (B), the actual making of 

15 such decision or the actual exercise of con16 trol in making such decision or in the con17 duct constituting the failure. 

18 ‘‘(ii) RULES OF CONSTRUCTION.—For 

19 purposes of clause (i), the employer or plan 

20 sponsor (or employee) shall not be con21 strued to be engaged in direct participation 

22 because of any form of decisionmaking or 

23 other conduct that is merely collateral or 

24 precedent to the decision described in sub25 paragraph (B) on a particular claim for 
188

•S 1945 IS 

1 benefits of a particular participant or bene2 ficiary, including (but not limited to)—

3 ‘‘(I) any participation by the em4 ployer or other plan sponsor (or em5 ployee) in the selection of the group 

6 health plan or health insurance cov7 erage involved or the third party ad8 ministrator or other agent; 

9 ‘‘(II) any engagement by the em10 ployer or other plan sponsor (or em11 ployee) in any cost-benefit analysis 

12 undertaken in connection with the se13 lection of, or continued maintenance 

14 of, the plan or coverage involved; 

15 ‘‘(III) any participation by the 

16 employer or other plan sponsor (or 

17 employee) in the process of creating, 

18 continuing, modifying, or terminating 

19 the plan or any benefit under the 

20 plan, if such process was not substan21 tially focused solely on the particular 

22 situation of the participant or bene23 ficiary referred to in paragraph 

24 (1)(A); and
189

•S 1945 IS 

1 ‘‘(IV) any participation by the 

2 employer or other plan sponsor (or 

3 employee) in the design of any benefit 

4 under the plan, including the amount 

5 of copayment and limits connected 

6 with such benefit. 

7 ‘‘(iv) IRRELEVANCE OF CERTAIN COL8 LATERAL EFFORTS MADE BY EMPLOYER

9 OR PLAN SPONSOR.—For purposes of this 

10 subparagraph, an employer or plan sponsor 

11 shall not be treated as engaged in direct 

12 participation in a decision with respect to 

13 any claim for benefits or denial thereof in 

14 the case of any particular participant or 

15 beneficiary solely by reason of—

16 ‘‘(I) any efforts that may have 

17 been made by the employer or plan 

18 sponsor to advocate for authorization 

19 of coverage for that or any other par20 ticipant or beneficiary (or any group 

21 of participants or beneficiaries), or 

22 ‘‘(II) any provision that may 

23 have been made by the employer or 

24 plan sponsor for benefits which are 

25 not covered under the terms and con-
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•S 1945 IS 

1 ditions of the plan for that or any 

2 other participant or beneficiary (or 

3 any group of participants or bene4 ficiaries). 

5 ‘‘(4) REQUIREMENT OF EXHAUSTION.—

6 ‘‘(A) IN GENERAL.—Except as provided in 

7 subparagraph (D), a cause of action may not be 

8 brought under paragraph (1) in connection with 

9 any denial of a claim for benefits of any indi10 vidual until all administrative processes under 

11 sections 102, 103, and 104 of the Bipartisan 

12 Patient Protection Act (if applicable) have been 

13 exhausted. 

14 ‘‘(B) LATE MANIFESTATION OF INJURY.—

15 ‘‘(i) IN GENERAL.—A participant or 

16 beneficiary shall not be precluded from 

17 pursuing a review under section 104 of the 

18 Bipartisan Patient Protection Act regard19 ing an injury that such participant or ben20 eficiary has experienced if the external re21 view entity first determines that the injury 

22 of such participant or beneficiary is a late 

23 manifestation of an earlier injury. 

24 ‘‘(ii) DEFINITION.—In this subpara25 graph, the term ‘late manifestation of an 
191

•S 1945 IS 

1 earlier injury’ means an injury sustained 

2 by the participant or beneficiary which was 

3 not known, and should not have been 

4 known, by such participant or beneficiary 

5 by the latest date that the requirements of 

6 subparagraph (A) should have been met 

7 regarding the claim for benefits which was 

8 denied. 

9 ‘‘(C) EXCEPTION FOR NEEDED CARE.—A 

10 participant or beneficiary may seek relief exclu11 sively in Federal court under subsection 

12 502(a)(1)(B) prior to the exhaustion of admin13 istrative remedies under sections 102, 103, or 

14 104 of the Bipartisan Patient Protection Act 

15 (as required under subparagraph (A)) if it is 

16 demonstrated to the court that the exhaustion 

17 of such remedies would cause irreparable harm 

18 to the health of the participant or beneficiary. 

19 Notwithstanding the awarding of relief under 

20 subsection 502(a)(1)(B) pursuant to this sub21 paragraph, no relief shall be available as a re22 sult of, or arising under, paragraph (1)(A) un23 less the requirements of subparagraph (A) are 

24 met. 

25 ‘‘(D) FAILURE TO REVIEW.—
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•S 1945 IS 

1 ‘‘(i) IN GENERAL.—If the external re2 view entity fails to make a determination 

3 within the time required under section 

4 104(e)(1)(A)(i), a participant or bene5 ficiary may bring an action under section 

6 514(d) after 10 additional days after the 

7 date on which such time period has expired 

8 and the filing of such action shall not af9 fect the duty of the independent medical 

10 reviewer (or reviewers) to make a deter11 mination pursuant to section 

12 104(e)(1)(A)(i). 

13 ‘‘(ii) EXPEDITED DETERMINATION.—

14 If the external review entity fails to make 

15 a determination within the time required 

16 under section 104(e)(1)(A)(ii), a partici17 pant or beneficiary may bring an action 

18 under this subsection and the filing of such 

19 an action shall not affect the duty of the 

20 independent medical reviewer (or review21 ers) to make a determination pursuant to 

22 section 104(e)(1)(A)(ii). 

23 ‘‘(E) RECEIPT OF BENEFITS DURING AP24 PEALS PROCESS.—Receipt by the participant or 

25 beneficiary of the benefits involved in the claim 
193

•S 1945 IS 

1 for benefits during the pendency of any admin2 istrative processes referred to in subparagraph 

3 (A) or of any action commenced under this sub4 section—

5 ‘‘(i) shall not preclude continuation of 

6 all such administrative processes to their 

7 conclusion if so moved by any party, and 

8 ‘‘(ii) shall not preclude any liability 

9 under subsection (a)(1)(C) and this sub10 section in connection with such claim. 

11 ‘‘(F) ADMISSIBLE.—Any determination 

12 made by a reviewer in an administrative pro13 ceeding under section 104 of the Bipartisan Pa14 tient Protection Act shall be admissible in any 

15 Federal or State court proceeding and shall be 

16 presented to the trier of fact. 

17 ‘‘(5) TOLLING PROVISION.—The statute of limi18 tations for any cause of action arising under section 

19 502(n) relating to a denial of a claim for benefits 

20 that is the subject of an action brought in State 

21 court shall be tolled until such time as the State 

22 court makes a final disposition, including all ap23 peals, of whether such claim should properly be 

24 within the jurisdiction of the State court. The tolling
194

•S 1945 IS 

1 period shall be determined by the applicable Federal 

2 or State law, whichever period is greater. 

3 ‘‘(6) EXCLUSION OF DIRECTED RECORD4 KEEPERS.—

5 ‘‘(A) IN GENERAL.—Subject to subpara6 graph (C), paragraph (1) shall not apply with 

7 respect to a directed recordkeeper in connection 

8 with a group health plan. 

9 ‘‘(B) DIRECTED RECORDKEEPER.—For 

10 purposes of this paragraph, the term ‘directed 

11 recordkeeper’ means, in connection with a 

12 group health plan, a person engaged in directed 

13 recordkeeping activities pursuant to the specific 

14 instructions of the plan or the employer or 

15 other plan sponsor, including the distribution of 

16 enrollment information and distribution of dis17 closure materials under this Act or title I of the 

18 Bipartisan Patient Protection Act and whose 

19 duties do not include making decisions on 

20 claims for benefits. 

21 ‘‘(C) LIMITATION.—Subparagraph (A) 

22 does not apply in connection with any directed 

23 recordkeeper to the extent that the directed rec24 ordkeeper fails to follow the specific instruction 
195

•S 1945 IS 

1 of the plan or the employer or other plan spon2 sor. 

3 ‘‘(7) CONSTRUCTION.—Nothing in this sub4 section shall be construed as—

5 ‘‘(A) saving from preemption a cause of 

6 action under State law for the failure to provide 

7 a benefit for an item or service which is specifi8 cally excluded under the group health plan in9 volved, except to the extent that—

10 ‘‘(i) the application or interpretation 

11 of the exclusion involves a determination 

12 described in section 104(d)(2) of the Bi13 partisan Patient Protection Act, or 

14 ‘‘(ii) the provision of the benefit for 

15 the item or service is required under Fed16 eral law or under applicable State law con17 sistent with subsection (b)(2)(B); 

18 ‘‘(B) preempting a State law which re19 quires an affidavit or certificate of merit in a 

20 civil action; 

21 ‘‘(C) affecting a cause of action or remedy 

22 under State law in connection with the provi23 sion or arrangement of excepted benefits (as de24 fined in section 733(c)), other than those de25 scribed in section 733(c)(2)(A); or 
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•S 1945 IS 

1 ‘‘(D) affecting a cause of action under 

2 State law other than a cause of action described 

3 in paragraph (1)(A). 

4 ‘‘(8) PURCHASE OF INSURANCE TO COVER LI5 ABILITY.—Nothing in section 410 shall be construed 

6 to preclude the purchase by a group health plan of 

7 insurance to cover any liability or losses arising 

8 under a cause of action described in paragraph 

9 (1)(A). 

10 ‘‘(9) RELIEF FROM LIABILITY FOR EMPLOYER

11 OR OTHER PLAN SPONSOR BY MEANS OF DES12 IGNATED DECISIONMAKER.—

13 ‘‘(A) IN GENERAL.—Paragraph (1) shall 

14 not apply with respect to any cause of action 

15 described in paragraph (1)(A) under State law 

16 insofar as such cause of action provides for li17 ability of an employer or plan sponsor (or an 

18 employee thereof acting within the scope of em19 ployment) with respect to a participant or bene20 ficiary, if with respect to the employer or plan 

21 sponsor there is deemed to be a designated de22 cisionmaker that meets the requirements of sec23 tion 502(o)(1) with respect to such participant 

24 or beneficiary. Such paragraph (1) shall apply 

25 with respect to any cause of action described in 
197

•S 1945 IS 

1 paragraph (1)(A) under State law against the 

2 designated decisionmaker of such employer or 

3 other plan sponsor with respect to the partici4 pant or beneficiary. 

5 ‘‘(B) AUTOMATIC DESIGNATION.—A health 

6 insurance issuer shall be deemed to be a des7 ignated decisionmaker for purposes of subpara8 graph (A) with respect to the participants and 

9 beneficiaries of an employer or plan sponsor, 

10 whether or not the employer or plan sponsor 

11 makes such a designation, and shall be deemed 

12 to have assumed unconditionally all liability of 

13 the employer or plan sponsor under such des14 ignation in accordance with subsection (o), un15 less the employer or plan sponsor affirmatively 

16 enters into a contract to prevent the service of 

17 the designated decisionmaker. 

18 ‘‘(10) PREVIOUSLY PROVIDED SERVICES.—

19 ‘‘(A) IN GENERAL.—Except as provided in 

20 this paragraph, a cause of action shall not arise 

21 under paragraph (1) where the denial involved 

22 relates to an item or service that has already 

23 been fully provided to the participant or bene24 ficiary under the plan or coverage and the claim 
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•S 1945 IS 

1 relates solely to the subsequent denial of pay2 ment for the provision of such item or service. 

3 ‘‘(B) EXCEPTION.—Nothing in subpara4 graph (A) shall be construed to—

5 ‘‘(i) prohibit a cause of action under 

6 paragraph (1) where the nonpayment in7 volved results in the participant or bene8 ficiary being unable to receive further 

9 items or services that are directly related 

10 to the item or service involved in the denial 

11 referred to in subparagraph (A) or that 

12 are part of a continuing treatment or se13 ries of procedures; 

14 ‘‘(ii) prohibit a cause of action under 

15 paragraph (1) relating to quality of care; 

16 or 

17 ‘‘(iii) limit liability that otherwise 

18 would arise from the provision of the item 

19 or services or the performance of a medical 

20 procedure. 

21 ‘‘(11) EXEMPTION FROM PERSONAL LIABILITY

22 FOR INDIVIDUAL MEMBERS OF BOARDS OF DIREC23 TORS, JOINT BOARDS OF TRUSTEES, ETC.—Any indi24 vidual who is—
199

•S 1945 IS 

1 ‘‘(A) a member of a board of directors of 

2 an employer or plan sponsor; or 

3 ‘‘(B) a member of an association, com4 mittee, employee organization, joint board of 

5 trustees, or other similar group of representa6 tives of the entities that are the plan sponsor 

7 of plan maintained by two or more employers 

8 and one or more employee organizations; 

9 shall not be personally liable under this subsection 

10 for conduct that is within the scope of employment 

11 of the individuals unless the individual acts in a 

12 fraudulent manner for personal enrichment. 

13 ‘‘(12) CHOICE OF LAW.—A cause of action 

14 brought under paragraph (1) shall be governed by 

15 the law (including choice of law rules) of the State 

16 in which the plaintiff resides. 

17 ‘‘(13) LIMITATION ON ATTORNEYS’ FEES.—

18 ‘‘(A) IN GENERAL.—Notwithstanding any 

19 other provision of law, or any arrangement, 

20 agreement, or contract regarding an attorney’s 

21 fee, the amount of an attorney’s contingency fee 

22 allowable for a cause of action brought under 

paragraph (1) shall not exceed 1 23 ⁄3 of the total 

24 amount of the plaintiff’s recovery (not including 
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•S 1945 IS 

1 the reimbursement of actual out-of-pocket ex2 penses of the attorney). 

3 ‘‘(B) DETERMINATION BY COURT.—The 

4 last court in which the action was pending upon 

5 the final disposition, including all appeals, of 

6 the action may review the attorney’s fee to en7 sure that the fee is a reasonable one. 

8 ‘‘(C) NO PREEMPTION OF STATE LAW.—

9 Subparagraph (A) shall not apply with respect 

10 to a cause of action under paragraph (1) that 

11 is brought in a State that has a law or frame12 work of laws with respect to the amount of an 

13 attorney’s contingency fee that may be incurred 

14 for the representation of a participant or bene15 ficiary (or the estate of such participant or ben16 eficiary) who brings such a cause of action. 

17 ‘‘(e) RULES OF CONSTRUCTION RELATING TO

18 HEALTH CARE.—Nothing in this title shall be construed 

19 as—

20 ‘‘(1) affecting any State law relating to the 

21 practice of medicine or the provision of, or the fail22 ure to provide, medical care, or affecting any action 

23 (whether the liability is direct or vicarious) based 

24 upon such a State law, 
201

•S 1945 IS 

1 ‘‘(2) superseding any State law permitted under 

2 section 152(b)(1)(A) of the Bipartisan Patient Pro3 tection Act, or 

4 ‘‘(3) affecting any applicable State law with re5 spect to limitations on monetary damages.’’. 

6 (c) EFFECTIVE DATE.—The amendments made by 

7 this section shall apply to acts and omissions (from which 

8 a cause of action arises) occurring on or after October 1, 

9 2004. 

10 SEC. 403. LIMITATION ON CERTAIN CLASS ACTION LITIGA11 TION. 

12 Section 502 of the Employee Retirement Income Se13 curity Act of 1974 (29 U.S.C. 1132), as amended by sec14 tion 402, is further amended by adding at the end the 

15 following: 

16 ‘‘(p) LIMITATION ON CLASS ACTION LITIGATION.—

17 ‘‘(1) IN GENERAL.—Any claim or cause of ac18 tion that is maintained under this section in connec19 tion with a group health plan, or health insurance 

20 coverage issued in connection with a group health 

21 plan, as a class action, derivative action, or as an ac22 tion on behalf of any group of 2 or more claimants, 

23 may be maintained only if the class, the derivative 

24 claimant, or the group of claimants is limited to the 

25 participants or beneficiaries of a group health plan 
202

•S 1945 IS 

1 established by only 1 plan sponsor. No action main2 tained by such class, such derivative claimant, or 

3 such group of claimants may be joined in the same 

4 proceeding with any action maintained by another 

5 class, derivative claimant, or group of claimants or 

6 consolidated for any purpose with any other pro7 ceeding. In this paragraph, the terms ‘group health 

8 plan’ and ‘health insurance coverage’ have the mean9 ings given such terms in section 733. 

10 ‘‘(2) EFFECTIVE DATE.—This subsection shall 

11 apply to all civil actions that are filed on or after 

12 January 1, 2004.’’. 

13 SEC. 404. LIMITATIONS ON ACTIONS. 

14 Section 502 of the Employee Retirement Income Se15 curity Act of 1974 (29 U.S.C. 1132) (as amended by sec16 tion 402(a)) is amended further by adding at the end the 

17 following new subsection: 

18 ‘‘(q) LIMITATIONS ON ACTIONS RELATING TO GROUP

19 HEALTH PLANS.—

20 ‘‘(1) IN GENERAL.—Except as provided in para21 graph (2), no action may be brought under sub22 section (a)(1)(B), (a)(2), or (a)(3) by a participant 

23 or beneficiary seeking relief based on the application 

24 of any provision in section 101, subtitle B, or sub-
203

•S 1945 IS 

1 title D of title I of the Bipartisan Patient Protection 

2 Act (as incorporated under section 714). 

3 ‘‘(2) CERTAIN ACTIONS ALLOWABLE.—An ac4 tion may be brought under subsection (a)(1)(B), 

5 (a)(2), or (a)(3) by a participant or beneficiary seek6 ing relief based on the application of section 101, 

7 113, 114, 115, 116, 117, 118(a)(3), 119, or 120 of 

8 the Bipartisan Patient Protection Act (as incor9 porated under section 714) to the individual cir10 cumstances of that participant or beneficiary, except 

11 that—

12 ‘‘(A) such an action may not be brought or 

13 maintained as a class action; and 

14 ‘‘(B) in such an action, relief may only 

15 provide for the provision of (or payment of) 

16 benefits, items, or services denied to the indi17 vidual participant or beneficiary involved (and 

18 for attorney’s fees and the costs of the action, 

19 at the discretion of the court) and shall not pro20 vide for any other relief to the participant or 

21 beneficiary or for any relief to any other person. 

22 ‘‘(3) OTHER PROVISIONS UNAFFECTED.—Noth23 ing in this subsection shall be construed as affecting 

24 subsections (a)(1)(C) and (n) or section 514(d).
204

•S 1945 IS 

1 ‘‘(4) ENFORCEMENT BY SECRETARY UNAF2 FECTED.—Nothing in this subsection shall be con3 strued as affecting any action brought by the Sec4 retary.’’. 

5 SEC. 405. COOPERATION BETWEEN FEDERAL AND STATE 

6 AUTHORITIES. 

7 Subpart C of part 7 of subtitle B of title I of the 

8 Employee Retirement Income Security Act of 1974 (29 

9 U.S.C. 1191 et seq.) is amended by adding at the end 

10 the following new section: 

11 ‘‘SEC. 735. COOPERATION BETWEEN FEDERAL AND STATE 

12 AUTHORITIES. 

13 ‘‘(a) AGREEMENT WITH STATES.—A State may 

14 enter into an agreement with the Secretary for the delega15 tion to the State of some or all of the Secretary’s authority 

16 under this title to enforce the requirements applicable 

17 under title I of the Bipartisan Patient Protection Act with 

18 respect to health insurance coverage offered by a health 

19 insurance issuer and with respect to a group health plan 

20 that is a non-Federal governmental plan. 

21 ‘‘(b) DELEGATIONS.—Any department, agency, or in22 strumentality of a State to which authority is delegated 

23 pursuant to an agreement entered into under this section 

24 may, if authorized under State law and to the extent con-
205

•S 1945 IS 

1 sistent with such agreement, exercise the powers of the 

2 Secretary under this title which relate to such authority.’’. 

3 SEC. 406. SENSE OF THE SENATE CONCERNING THE IMPOR4 TANCE OF CERTAIN UNPAID SERVICES. 

5 It is the sense of the Senate that the court should 

6 consider the loss of a nonwage earning spouse or parent 

7 as an economic loss for the purposes of this section. Fur8 thermore, the court should define the compensation for the 

9 loss not as minimum services, but, rather, in terms that 

10 fully compensate for the true and whole replacement cost 

11 to the family. 

12 TITLE V—EFFECTIVE DATES; CO13 ORDINATION IN IMPLEMEN14 TATION 

15 SEC. 501. EFFECTIVE DATES. 

16 (a) GROUP HEALTH COVERAGE.—

17 (1) IN GENERAL.—Subject to paragraph (2) 

18 and subsection (d), the amendments made by sec19 tions 201(a), 401, and 403 (and title I insofar as it 

20 relates to such sections) shall apply with respect to 

21 group health plans, and health insurance coverage 

22 offered in connection with group health plans, for 

23 plan years beginning on or after October 1, 2004 (in 

24 this section referred to as the ‘‘general effective 

25 date’’). 
206

•S 1945 IS 

1 (2) TREATMENT OF COLLECTIVE BARGAINING

2 AGREEMENTS.—In the case of a group health plan 

3 maintained pursuant to one or more collective bar4 gaining agreements between employee representa5 tives and one or more employers ratified before the 

6 date of the enactment of this Act, the amendments 

7 made by sections 201(a), 401, and 403 (and title I 

8 insofar as it relates to such sections) shall not apply 

9 to plan years beginning before the later of—

10 (A) the date on which the last collective 

11 bargaining agreements relating to the plan ter12 minates (excluding any extension thereof agreed 

13 to after the date of the enactment of this Act); 

14 or 

15 (B) the general effective date; 

16 but shall apply not later than 1 year after the gen17 eral effective date. For purposes of subparagraph 

18 (A), any plan amendment made pursuant to a collec19 tive bargaining agreement relating to the plan which 

20 amends the plan solely to conform to any require21 ment added by this Act shall not be treated as a ter22 mination of such collective bargaining agreement. 

23 (b) INDIVIDUAL HEALTH INSURANCE COVERAGE.—

24 Subject to subsection (d), the amendments made by sec25 tion 202 shall apply with respect to individual health in-
207

•S 1945 IS 

1 surance coverage offered, sold, issued, renewed, in effect, 

2 or operated in the individual market on or after the gen3 eral effective date. 

4 (c) TREATMENT OF RELIGIOUS NONMEDICAL PRO5 VIDERS.—

6 (1) IN GENERAL.—Nothing in this Act (or the 

7 amendments made thereby) shall be construed to—

8 (A) restrict or limit the right of group 

9 health plans, and of health insurance issuers of10 fering health insurance coverage, to include as 

11 providers religious nonmedical providers; 

12 (B) require such plans or issuers to—

13 (i) utilize medically based eligibility 

14 standards or criteria in deciding provider 

15 status of religious nonmedical providers; 

16 (ii) use medical professionals or cri17 teria to decide patient access to religious 

18 nonmedical providers; 

19 (iii) utilize medical professionals or 

20 criteria in making decisions in internal or 

21 external appeals regarding coverage for 

22 care by religious nonmedical providers; or 

23 (iv) compel a participant or bene24 ficiary to undergo a medical examination 

25 or test as a condition of receiving health 
208

•S 1945 IS 

1 insurance coverage for treatment by a reli2 gious nonmedical provider; or 

3 (C) require such plans or issuers to ex4 clude religious nonmedical providers because 

5 they do not provide medical or other required 

6 data, if such data is inconsistent with the reli7 gious nonmedical treatment or nursing care 

8 provided by the provider. 

9 (2) RELIGIOUS NONMEDICAL PROVIDER.—For 

10 purposes of this subsection, the term ‘‘religious non11 medical provider’’ means a provider who provides no 

12 medical care but who provides only religious non13 medical treatment or religious nonmedical nursing 

14 care. 

15 (d) TRANSITION FOR NOTICE REQUIREMENT.—The 

16 disclosure of information required under section 121 of 

17 this Act shall first be provided pursuant to—

18 (1) subsection (a) with respect to a group 

19 health plan that is maintained as of the general ef20 fective date, not later than 30 days before the begin21 ning of the first plan year to which title I applies 

22 in connection with the plan under such subsection; 

23 or 

24 (2) subsection (b) with respect to a individual 

25 health insurance coverage that is in effect as of the
209

•S 1945 IS 

1 general effective date, not later than 30 days before 

2 the first date as of which title I applies to the cov3 erage under such subsection. 

4 SEC. 502. COORDINATION IN IMPLEMENTATION. 

5 The Secretary of Labor and the Secretary of Health 

6 and Human Services shall ensure, through the execution 

7 of an interagency memorandum of understanding among 

8 such Secretaries, that—

9 (1) regulations, rulings, and interpretations 

10 issued by such Secretaries relating to the same mat11 ter over which such Secretaries have responsibility 

12 under the provisions of this Act (and the amend13 ments made thereby) are administered so as to have 

14 the same effect at all times; and 

15 (2) coordination of policies relating to enforcing 

16 the same requirements through such Secretaries in 

17 order to have a coordinated enforcement strategy 

18 that avoids duplication of enforcement efforts and 

19 assigns priorities in enforcement. 

20 SEC. 503. SEVERABILITY. 

21 If any provision of this Act, an amendment made by 

22 this Act, or the application of such provision or amend23 ment to any person or circumstance is held to be unconsti24 tutional, the remainder of this Act, the amendments made 

25 by this Act, and the application of the provisions of such 
210

•S 1945 IS 

1 to any person or circumstance shall not be affected there2 by. 

3 TITLE VI—MISCELLANEOUS 

4 PROVISIONS 

5 SEC. 601. NO IMPACT ON SOCIAL SECURITY TRUST FUND. 

6 (a) IN GENERAL.—Nothing in this Act (or an amend7 ment made by this Act) shall be construed to alter or 

8 amend the Social Security Act (or any regulation promul9 gated under that Act). 

10 (b) TRANSFERS.—

11 (1) ESTIMATE OF SECRETARY.—The Secretary 

12 of the Treasury shall annually estimate the impact 

13 that the enactment of this Act has on the income 

14 and balances of the trust funds established under 

15 section 201 of the Social Security Act (42 U.S.C. 

16 401). 

17 (2) TRANSFER OF FUNDS.—If, under para18 graph (1), the Secretary of the Treasury estimates 

19 that the enactment of this Act has a negative impact 

20 on the income and balances of the trust funds estab21 lished under section 201 of the Social Security Act 

22 (42 U.S.C. 401), the Secretary shall transfer, not 

23 less frequently than quarterly, from the general reve24 nues of the Federal Government an amount suffi25 cient so as to ensure that the income and balances 
211

•S 1945 IS 

1 of such trust funds are not reduced as a result of 

2 the enactment of such Act. 

3 SEC. 602. SENSE OF SENATE WITH RESPECT TO PARTICIPA4 TION IN CLINICAL TRIALS AND ACCESS TO 

5 SPECIALTY CARE. 

6 (a) FINDINGS.—The Senate finds the following: 

7 (1) Breast cancer is the most common form of 

8 cancer among women, excluding skin cancers. 

9 (2) During 2001, 182,800 new cases of female 

10 invasive breast cancer will be diagnosed, and 40,800 

11 women will die from the disease. 

12 (3) In addition, 1,400 male breast cancer cases 

13 are projected to be diagnosed, and 400 men will die 

14 from the disease. 

15 (4) Breast cancer is the second leading cause of 

16 cancer death among all women and the leading 

17 cause of cancer death among women between ages 

18 40 and 55. 

19 (5) This year 8,600 children are expected to be 

20 diagnosed with cancer. 

21 (6) 1,500 children are expected to die from can22 cer this year. 

23 (7) There are approximately 333,000 people di24 agnosed with multiple sclerosis in the United States 

25 and 200 more cases are diagnosed each week. 
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•S 1945 IS 

1 (8) Parkinson’s disease is a progressive disorder 

2 of the central nervous system affecting 1,000,000 in 

3 the United States. 

4 (9) An estimated 198,100 men will be diag5 nosed with prostate cancer this year. 

6 (10) 31,500 men will die from prostate cancer 

7 this year. It is the second leading cause of cancer in 

8 men. 

9 (11) While information obtained from clinical 

10 trials is essential to finding cures for diseases, it is 

11 still research which carries the risk of fatal results. 

12 Future efforts should be taken to protect the health 

13 and safety of adults and children who enroll in clin14 ical trials. 

15 (12) While employers and health plans should 

16 be responsible for covering the routine costs associ17 ated with federally approved or funded clinical trials, 

18 such employers and health plans should not be held 

19 legally responsible for the design, implementation, or 

20 outcome of such clinical trials, consistent with any 

21 applicable State or Federal liability statutes. 

22 (b) SENSE OF THE SENATE.—It is the sense of the 

23 Senate that— 

24 (1) men and women battling life-threatening, 

25 deadly diseases, including advanced breast or ovar-
213

•S 1945 IS 

1 ian cancer, should have the opportunity to partici2 pate in a federally approved or funded clinical trial 

3 recommended by their physician; 

4 (2) an individual should have the opportunity to 

5 participate in a federally approved or funded clinical 

6 trial recommended by their physician if—

7 (A) that individual—

8 (i) has a life-threatening or serious ill9 ness for which no standard treatment is ef10 fective; 

11 (ii) is eligible to participate in a feder12 ally approved or funded clinical trial ac13 cording to the trial protocol with respect to 

14 treatment of the illness; 

15 (B) that individual’s participation in the 

16 trial offers meaningful potential for significant 

17 clinical benefit for the individual; and 

18 (C) either—

19 (i) the referring physician is a partici20 pating health care professional and has 

21 concluded that the individual’s participa22 tion in the trial would be appropriate, 

23 based upon the individual meeting the con24 ditions described in subparagraph (A); or
214

•S 1945 IS 

1 (ii) the participant, beneficiary, or en2 rollee provides medical and scientific infor3 mation establishing that the individual’s 

4 participation in the trial would be appro5 priate, based upon the individual meeting 

6 the conditions described in subparagraph 

7 (A); 

8 (3) a child with a life-threatening illness, in9 cluding cancer, should be allowed to participate in a 

10 federally approved or funded clinical trial if that 

11 participation meets the requirements of paragraph 

12 (2); 

13 (4) a child with a rare cancer should be allowed 

14 to go to a cancer center capable of providing high 

15 quality care for that disease; and 

16 (5) a health maintenance organization’s deci17 sion that an in-network physician without the nec18 essary expertise can provide care for a seriously ill 

19 patient, including a woman battling cancer, should 

20 be appealable to an independent, impartial body, and 

21 that this same right should be available to all Ameri22 cans in need of access to high quality specialty care. 

23 SEC. 603. SENSE OF THE SENATE REGARDING FAIR REVIEW 

24 PROCESS. 

25 (a) FINDINGS.—The Senate finds the following: 
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•S 1945 IS 

1 (1) A fair, timely, impartial independent exter2 nal appeals process is essential to any meaningful 

3 program of patient protection. 

4 (2) The independence and objectivity of the re5 view organization and review process must be en6 sured. 

7 (3) It is incompatible with a fair and inde8 pendent appeals process to allow a health mainte9 nance organization to select the review organization 

10 that is entrusted with providing a neutral and unbi11 ased medical review. 

12 (4) The American Arbitration Association and 

13 arbitration standards adopted under chapter 44 of 

14 title 28, United States Code (28 U.S.C. 651 et seq.) 

15 both prohibit, as inherently unfair, the right of one 

16 party to a dispute to choose the judge in that dis17 pute. 

18 (b) SENSE OF THE SENATE.—It is the sense of the 

19 Senate that—

20 (1) every patient who is denied care by a health 

21 maintenance organization or other health insurance 

22 company should be entitled to a fair, speedy, impar23 tial appeal to a review organization that has not 

24 been selected by the health plan; 
216

•S 1945 IS 

1 (2) the States should be empowered to maintain 

2 and develop the appropriate process for selection of 

3 the independent external review entity; 

4 (3) a child battling a rare cancer whose health 

5 maintenance organization has denied a covered 

6 treatment recommended by its physician should be 

7 entitled to a fair and impartial external appeal to a 

8 review organization that has not been chosen by the 

9 organization or plan that has denied the care; and 

10 (4) patient protection legislation should not pre11 empt existing State laws in States where there al12 ready are strong laws in place regarding the selec13 tion of independent review organizations. 

14 SEC. 604. ANNUAL REVIEW. 

15 (a) IN GENERAL.—Not later than 24 months after 

16 the general effective date referred to in section 501(a)(1), 

17 and annually thereafter for each of the succeeding 4 cal18 endar years (or until a repeal is effective under subsection 

19 (b)), the Secretary of Health and Human Services shall 

20 request that the Institute of Medicine of the National 

21 Academy of Sciences prepare and submit to the appro22 priate committees of Congress a report concerning the im23 pact of this Act, and the amendments made by this Act, 

24 on the number of individuals in the United States with 

25 health insurance coverage. 
217

•S 1945 IS 

1 (b) FUNDING.—From funds appropriated to the De2 partment of Health and Human Services for fiscal years 

3 2004 and 2005, the Secretary of Health and Human Serv4 ices shall provide for such funding as the Secretary deter5 mines necessary for the conduct of the study of the Na6 tional Academy of Sciences under this section.

Æ