I 

108TH CONGRESS 

2D SESSION H. R. 4628

To amend the Public Health Service Act, the Employee Retirement Income 

Security Act of 1974, and the Internal Revenue Code of 1986 to protect 

consumers in managed care plans and other health coverage. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 21, 2004

Mr. DINGELL (for himself, Mr. ANDREWS, Mr. BERRY, Mr. STENHOLM, Mr. 

GEORGE MILLER of California, Mr. WAXMAN, Mr. STARK, Mr. RANGEL, 

Mr. BROWN of Ohio, Ms. PELOSI, Mr. HOYER, Mr. MENENDEZ, Mr. 

FROST, Mr. SANDLIN, Mr. EDWARDS, Mr. DAVIS of Florida, Mr. MEEHAN, Mr. LAMPSON, Mr. HOLDEN, Mr. GREEN of Texas, Mr. BELL, Mr. 

MOORE, Mr. TURNER of Texas, Mr. PALLONE, Mrs. CAPPS, Mr. MEEKS

of New York, Ms. SCHAKOWSKY, Mrs. MALONEY, Ms. DELAURO, Ms. 

WATERS, Mr. LARSON of Connecticut, Mr. JACKSON of Illinois, Mr. KENNEDY of Rhode Island, Ms. SLAUGHTER, Mr. SERRANO, Mr. LIPINSKI, 

Mr. ETHERIDGE, Mr. BOSWELL, Mr. STRICKLAND, Mr. HOLT, Ms. KAPTUR, Mr. ACKERMAN, Mr. HINCHEY, Mr. MCNULTY, Mr. GORDON, Ms. 

DEGETTE, Ms. KILPATRICK, Mr. SPRATT, Mr. SKELTON, Mr. CONYERS, 

Mr. DOYLE, Mr. OBERSTAR, Mr. STUPAK, Mr. SHERMAN, Mrs. MCCARTHY of New York, Ms. LINDA T. SA ́NCHEZ of California, and Mrs. 

TAUSCHER) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on 

Education and the Workforce and Ways and Means, for a period to be 

subsequently determined by the Speaker, in each case for consideration 

of such provisions as fall within the jurisdiction of the committee concerned 

A BILL

To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal 
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Revenue Code of 1986 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 ‘‘Patients’ Bill of Rights Act of 2004’’. 

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 

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. 
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Sec. 135. Protection for patient advocacy. 

Subtitle E—Definitions 

Sec. 151. Definitions. 

Sec. 152. Preemption; State flexibility; construction. 

Sec. 153. Exclusions. 

Sec. 154. Treatment of excepted benefits. 

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 INSURANCE PROGRAMS 

Sec. 301. Application of patient protection standards to Federal health insurance 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. Cooperation between Federal and State authorities. 

TITLE V—AMENDMENTS TO THE INTERNAL REVENUE CODE OF 

1986

Subtitle A—Application of patient protection provisions 

Sec. 501. Application to group health plans under the Internal Revenue Code 

of 1986. 

Sec. 502. Conforming enforcement for women’s health and cancer rights. 

Subtitle B—Health care coverage access tax incentives 

Sec. 511. Credit for health insurance expenses of small businesses. 

Sec. 512. Certain grants by private foundations to qualified health benefit purchasing coalitions. 

Sec. 513. State grant program for market innovation. 

Sec. 514. Grant program to facilitate health benefits information for small employers. 

Sec. 515. State grant program for market innovation. 

TITLE VI—EFFECTIVE DATES; COORDINATION IN 

IMPLEMENTATION 

Sec. 601. Effective dates. 
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Sec. 602. Coordination in implementation. 

Sec. 603. Severability. 

TITLE VII—MISCELLANEOUS PROVISIONS 

Sec. 701. No impact on Social Security Trust Fund.

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 

13 a utilization review program that meets the require14 ments of this section and section 102. 

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

16 section shall be construed as preventing a group 

17 health plan or health insurance issuer from arrang18 ing through a contract or otherwise for persons or 

19 entities to conduct utilization review activities on be20 half of the plan or issuer, so long as such activities 

21 are conducted in accordance with a utilization review 

22 program that meets the requirements of this section. 
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1 (3) UTILIZATION REVIEW DEFINED.—For pur2 poses of this section, the terms ‘‘utilization review’’ 

3 and ‘‘utilization review activities’’ mean procedures 

4 used to monitor or evaluate the use or coverage, 

5 clinical necessity, appropriateness, efficacy, or effi6 ciency of health care services, procedures or settings, 

7 and includes prospective review, concurrent review, 

8 second opinions, case management, discharge plan9 ning, or retrospective review. 

10 (b) WRITTEN POLICIES AND CRITERIA.—

11 (1) WRITTEN POLICIES.—A utilization review 

12 program shall be conducted consistent with written 

13 policies and procedures that govern all aspects of the 

14 program. 

15 (2) USE OF WRITTEN CRITERIA.—

16 (A) IN GENERAL.—Such a program shall 

17 utilize written clinical review criteria developed 

18 with input from a range of appropriate actively 

19 practicing health care professionals, as deter20 mined by the plan, pursuant to the program. 

21 Such criteria shall include written clinical re22 view criteria that are based on valid clinical evi23 dence where available and that are directed spe24 cifically at meeting the needs of at-risk popu25 lations and covered individuals with chronic 
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1 conditions or severe illnesses, including gender2 specific criteria and pediatric-specific criteria 

3 where available and appropriate. 

4 (B) CONTINUING USE OF STANDARDS IN

5 RETROSPECTIVE REVIEW.—If a health care 

6 service has been specifically pre-authorized or 

7 approved for a participant, beneficiary, or en8 rollee under such a program, the program shall 

9 not, pursuant to retrospective review, revise or 

10 modify the specific standards, criteria, or proce11 dures used for the utilization review for proce12 dures, treatment, and services delivered to the 

13 enrollee during the same course of treatment. 

14 (C) REVIEW OF SAMPLE OF CLAIMS DENI15 ALS.—Such a program shall provide for a peri16 odic evaluation of the clinical appropriateness of 

17 at least a sample of denials of claims for bene18 fits. 

19 (c) CONDUCT OF PROGRAM ACTIVITIES.—

20 (1) ADMINISTRATION BY HEALTH CARE PRO21 FESSIONALS.—A utilization review program shall be 

22 administered by qualified health care professionals 

23 who shall oversee review decisions. 

24 (2) USE OF QUALIFIED, INDEPENDENT PER25 SONNEL.—
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1 (A) IN GENERAL.—A utilization review 

2 program shall provide for the conduct of utiliza3 tion review activities only through personnel 

4 who are qualified and have received appropriate 

5 training in the conduct of such activities under 

6 the program. 

7 (B) PROHIBITION OF CONTINGENT COM8 PENSATION ARRANGEMENTS.—Such a program 

9 shall not, with respect to utilization review ac10 tivities, permit or provide compensation or any11 thing of value to its employees, agents, or con12 tractors in a manner that encourages denials of 

13 claims for benefits. 

14 (C) PROHIBITION OF CONFLICTS.—Such a 

15 program shall not permit a health care profes16 sional who is providing health care services to 

17 an individual to perform utilization review ac18 tivities in connection with the health care serv19 ices being provided to the individual. 

20 (3) ACCESSIBILITY OF REVIEW.—Such a pro21 gram shall provide that appropriate personnel per22 forming utilization review activities under the pro23 gram, including the utilization review administrator, 

24 are reasonably accessible by toll-free telephone dur25 ing normal business hours to discuss patient care 
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1 and allow response to telephone requests, and that 

2 appropriate provision is made to receive and respond 

3 promptly to calls received during other hours. 

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

5 shall not provide for the performance of utilization 

6 review activities with respect to a class of services 

7 furnished to an individual more frequently than is 

8 reasonably required to assess whether the services 

9 under review are medically necessary and appro10 priate. 

11 SEC. 102. PROCEDURES FOR INITIAL CLAIMS FOR BENE12 FITS AND PRIOR AUTHORIZATION DETER13 MINATIONS. 

14 (a) PROCEDURES OF INITIAL CLAIMS FOR BENE15 FITS.—

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

17 health insurance issuer offering health insurance 

18 coverage, shall—

19 (A) make a determination on an initial 

20 claim for benefits by a participant, beneficiary, 

21 or enrollee (or authorized representative) re22 garding payment or coverage for items or serv23 ices under the terms and conditions of the plan 

24 or coverage involved, including any cost-sharing 

25 amount that the participant, beneficiary, or en-
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1 rollee is required to pay with respect to such 

2 claim for benefits; and 

3 (B) notify a participant, beneficiary, or en4 rollee (or authorized representative) and the 

5 treating health care professional involved re6 garding a determination on an initial claim for 

7 benefits made under the terms and conditions 

8 of the plan or coverage, including any cost-shar9 ing amounts that the participant, beneficiary, 

10 or enrollee may be required to make with re11 spect to such claim for benefits, and of the 

12 right of the participant, beneficiary, or enrollee 

13 to an internal appeal under section 103. 

14 (2) ACCESS TO INFORMATION.—

15 (A) TIMELY PROVISION OF NECESSARY IN16 FORMATION.—With respect to an initial claim 

17 for benefits, the participant, beneficiary, or en18 rollee (or authorized representative) and the 

19 treating health care professional (if any) shall 

20 provide the plan or issuer with access to infor21 mation requested by the plan or issuer that is 

22 necessary to make a determination relating to 

23 the claim. Such access shall be provided not 

24 later than 5 days after the date on which the 

25 request for information is received, or, in a case 
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1 described in subparagraph (B) or (C) of sub2 section (b)(1), by such earlier time as may be 

3 necessary to comply with the applicable timeline 

4 under such subparagraph. 

5 (B) LIMITED EFFECT OF FAILURE ON

6 PLAN OR ISSUER’S OBLIGATIONS.—Failure of 

7 the participant, beneficiary, or enrollee to com8 ply with the requirements of subparagraph (A) 

9 shall not remove the obligation of the plan or 

10 issuer to make a decision in accordance with 

11 the medical exigencies of the case and as soon 

12 as possible, based on the available information, 

13 and failure to comply with the time limit estab14 lished by this paragraph shall not remove the 

15 obligation of the plan or issuer to comply with 

16 the requirements of this section. 

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

18 for benefits involving an expedited or concurrent de19 termination, a participant, beneficiary, or enrollee 

20 (or authorized representative) may make an initial 

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

22 health insurance issuer offering health insurance 

23 coverage, may require that the participant, bene24 ficiary, or enrollee (or authorized representative) 

25 provide written confirmation of such request in a 
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1 timely manner on a form provided by the plan or 

2 issuer. In the case of such an oral request for bene3 fits, the making of the request (and the timing of 

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

5 time of a claim for such benefits without regard to 

6 whether and when a written confirmation of such re7 quest is made. 

8 (b) TIMELINE FOR MAKING DETERMINATIONS.—

9 (1) PRIOR AUTHORIZATION DETERMINATION.—

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

11 and a health insurance issuer offering health in12 surance coverage, shall make a prior authoriza13 tion determination on a claim for benefits 

14 (whether oral or written) in accordance with the 

15 medical exigencies of the case and as soon as 

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

17 the date on which the plan or issuer receives in18 formation that is reasonably necessary to enable 

19 the plan or issuer to make a determination on 

20 the request for prior authorization and in no 

21 case later than 28 days after the date of the 

22 claim for benefits is received. 

23 (B) EXPEDITED DETERMINATION.—Not24 withstanding subparagraph (A), a group health 

25 plan, and a health insurance issuer offering 
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1 health insurance coverage, shall expedite a prior 

2 authorization determination on a claim for ben3 efits described in such subparagraph when a re4 quest for such an expedited determination is 

5 made by a participant, beneficiary, or enrollee 

6 (or authorized representative) at any time dur7 ing the process for making a determination and 

8 a health care professional certifies, with the re9 quest, that a determination under the proce10 dures described in subparagraph (A) would seri11 ously jeopardize the life or health of the partici12 pant, beneficiary, or enrollee or the ability of 

13 the participant, beneficiary, or enrollee to main14 tain or regain maximum function. Such deter15 mination shall be made in accordance with the 

16 medical exigencies of the case and as soon as 

17 possible, but in no case later than 72 hours 

18 after the time the request is received by the 

19 plan or issuer under this subparagraph. 

20 (C) ONGOING CARE.—

21 (i) CONCURRENT REVIEW.—

22 (I) IN GENERAL.—Subject to 

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

24 review of ongoing care (including hos25 pitalization), which results in a termi-
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1 nation or reduction of such care, the 

2 plan or issuer must provide by tele3 phone and in printed form notice of 

4 the concurrent review determination 

5 to the individual or the individual’s 

6 designee and the individual’s health 

7 care provider in accordance with the 

8 medical exigencies of the case and as 

9 soon as possible, with sufficient time 

10 prior to the termination or reduction 

11 to allow for an appeal under section 

12 103(b)(3) to be completed before the 

13 termination or reduction takes effect. 

14 (II) CONTENTS OF NOTICE.—

15 Such notice shall include, with respect 

16 to ongoing health care items and serv17 ices, the number of ongoing services 

18 approved, the new total of approved 

19 services, the date of onset of services, 

20 and the next review date, if any, as 

21 well as a statement of the individual’s 

22 rights to further appeal. 

23 (ii) RULE OF CONSTRUCTION.—Clause 

24 (i) shall not be construed as requiring 

25 plans or issuers to provide coverage of care 
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1 that would exceed the coverage limitations 

2 for such care. 

3 (2) RETROSPECTIVE DETERMINATION.—A 

4 group health plan, and a health insurance issuer of5 fering health insurance coverage, shall make a retro6 spective determination on a claim for benefits in ac7 cordance with the medical exigencies of the case and 

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

9 the date on which the plan or issuer receives infor10 mation that is reasonably necessary to enable the 

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

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

13 claim for benefits. 

14 (c) NOTICE OF A DENIAL OF A CLAIM FOR BENE15 FITS.—Written notice of a denial made under an initial 

16 claim for benefits shall be issued to the participant, bene17 ficiary, or enrollee (or authorized representative) and the 

18 treating health care professional in accordance with the 

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

20 in no case later than 2 days after the date of the deter21 mination (or, in the case described in subparagraph (B) 

22 or (C) of subsection (b)(1), within the 72-hour or applica23 ble period referred to in such subparagraph). 

24 (d) REQUIREMENTS OF NOTICE OF DETERMINA25 TIONS.—The written notice of a denial of a claim for bene-
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1 fits determination under subsection (c) shall be provided 

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

3 understood by the participant, beneficiary, or enrollee and 

4 shall include—

5 (1) the specific reasons for the determination 

6 (including a summary of the clinical or scientific evi7 dence used in making the determination); 

8 (2) the procedures for obtaining additional in9 formation concerning the determination; and 

10 (3) notification of the right to appeal the deter11 mination and instructions on how to initiate an ap12 peal in accordance with section 103. 

13 (e) DEFINITIONS.—For purposes of this part: 

14 (1) AUTHORIZED REPRESENTATIVE.—The term 

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

16 an individual who is a participant, beneficiary, or en17 rollee, any health care professional or other person 

18 acting on behalf of the individual with the individ19 ual’s consent or without such consent if the indi20 vidual is medically unable to provide such consent. 

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

22 for benefits’’ means any request for coverage (in23 cluding authorization of coverage), for eligibility, or 

24 for payment in whole or in part, for an item or serv-
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1 ice under a group health plan or health insurance 

2 coverage. 

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

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

5 benefits, a denial (in whole or in part) of, or a fail6 ure to act on a timely basis upon, the claim for ben7 efits and includes a failure to provide benefits (in8 cluding items and services) required to be provided 

9 under this title. 

10 (4) TREATING HEALTH CARE PROFESSIONAL.—

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

12 with respect to services to be provided to a partici13 pant, beneficiary, or enrollee, a health care profes14 sional who is primarily responsible for delivering 

15 those services to the participant, beneficiary, or en16 rollee. 

17 SEC. 103. INTERNAL APPEALS OF CLAIMS DENIALS. 

18 (a) RIGHT TO INTERNAL APPEAL.—

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

20 enrollee (or authorized representative) may appeal 

21 any denial of a claim for benefits under section 102 

22 under the procedures described in this section. 

23 (2) TIME FOR APPEAL.—

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

25 and a health insurance issuer offering health in-
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1 surance coverage, shall ensure that a partici2 pant, beneficiary, or enrollee (or authorized rep3 resentative) has a period of not less than 180 

4 days beginning on the date of a denial of a 

5 claim for benefits under section 102 in which to 

6 appeal such denial under this section. 

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

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

9 be deemed to be the date as of which the partic10 ipant, beneficiary, or enrollee knew of the denial 

11 of the claim for benefits. 

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

13 issuer to issue a determination on a claim for bene14 fits under section 102 within the applicable timeline 

15 established for such a determination under such sec16 tion is a denial of a claim for benefits for purposes 

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

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

19 group health plan, or health insurance issuer offer20 ing health insurance coverage, may waive the inter21 nal review process under this section. In such case 

22 the plan or issuer shall provide notice to the partici23 pant, beneficiary, or enrollee (or authorized rep24 resentative) involved, the participant, beneficiary, or 

25 enrollee (or authorized representative) involved shall 
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1 be relieved of any obligation to complete the internal 

2 review involved, and may, at the option of such par3 ticipant, beneficiary, enrollee, or representative pro4 ceed directly to seek further appeal through external 

5 review under section 104 or otherwise. 

6 (b) TIMELINES FOR MAKING DETERMINATIONS.—

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

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

9 that involves an expedited or concurrent determina10 tion, a participant, beneficiary, or enrollee (or au11 thorized representative) may request such appeal 

12 orally. A group health plan, or health insurance 

13 issuer offering health insurance coverage, may re14 quire that the participant, beneficiary, or enrollee 

15 (or authorized representative) provide written con16 firmation of such request in a timely manner on a 

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

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

19 making of the request (and the timing of such re20 quest) shall be treated as the making at that time 

21 of a request for an appeal without regard to whether 

22 and when a written confirmation of such request is 

23 made. 

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

3 denial of a claim for benefits, the participant, 

4 beneficiary, or enrollee (or authorized represent5 ative) and the treating health care professional 

6 (if any) shall provide the plan or issuer with ac7 cess to information requested by the plan or 

8 issuer that is necessary to make a determina9 tion relating to the appeal. Such access shall be 

10 provided not later than 5 days after the date on 

11 which the request for information is received, 

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

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

14 may be necessary to comply with the applicable 

15 timeline 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) PRIOR AUTHORIZATION DETERMINA4 TIONS.—

5 (A) IN GENERAL.—Except as provided in 

6 this paragraph or paragraph (4), a group 

7 health plan, and a health insurance issuer offer8 ing health insurance coverage, shall make a de9 termination on an appeal of a denial of a claim 

10 for benefits under this subsection in accordance 

11 with the medical exigencies of the case and as 

12 soon as possible, but in no case later than 14 

13 days from the date on which the plan or issuer 

14 receives information that is reasonably nec15 essary to enable the plan or issuer to make a 

16 determination on the appeal and in no case 

17 later than 28 days after the date the request 

18 for the appeal is received. 

19 (B) EXPEDITED DETERMINATION.—Not20 withstanding subparagraph (A), a group health 

21 plan, and a health insurance issuer offering 

22 health insurance coverage, shall expedite a prior 

23 authorization determination on an appeal of a 

24 denial of a claim for benefits described in sub25 paragraph (A), when a request for such an ex-
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1 pedited determination is made by a participant, 

2 beneficiary, or enrollee (or authorized represent3 ative) at any time during the process for mak4 ing a determination and a health care profes5 sional certifies, with the request, that a deter6 mination under the procedures described in sub7 paragraph (A) would seriously jeopardize the 

8 life or health of the participant, beneficiary, or 

9 enrollee or the ability of the participant, bene10 ficiary, or enrollee to maintain or regain max11 imum function. Such determination shall be 

12 made in accordance with the medical exigencies 

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

14 case later than 72 hours after the time the re15 quest for such appeal is received by the plan or 

16 issuer under this subparagraph. 

17 (C) ONGOING CARE DETERMINATIONS.—

18 (i) IN GENERAL.—Subject to clause 

19 (ii), in the case of a concurrent review de20 termination described in section 

21 102(b)(1)(C)(i)(I), which results in a ter22 mination or reduction of such care, the 

23 plan or issuer must provide notice of the 

24 determination on the appeal under this 

25 section by telephone and in printed form to 
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1 the individual or the individual’s designee 

2 and the individual’s health care provider in 

3 accordance with the medical exigencies of 

4 the case and as soon as possible, with suf5 ficient time prior to the termination or re6 duction to allow for an external appeal 

7 under section 104 to be completed before 

8 the termination or reduction takes effect. 

9 (ii) RULE OF CONSTRUCTION.—Clause 

10 (i) shall not be construed as requiring 

11 plans or issuers to provide coverage of care 

12 that would exceed the coverage limitations 

13 for such care. 

14 (4) RETROSPECTIVE DETERMINATION.—A 

15 group health plan, and a health insurance issuer of16 fering health insurance coverage, shall make a retro17 spective determination on an appeal of a denial of a 

18 claim for benefits in no case later than 30 days after 

19 the date on which the plan or issuer receives nec20 essary information that is reasonably necessary to 

21 enable the plan or issuer to make a determination on 

22 the appeal and in no case later than 60 days after 

23 the date the request for the appeal is received. 

24 (c) CONDUCT OF REVIEW.—
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1 (1) IN GENERAL.—A review of a denial of a 

2 claim for benefits under this section shall be con3 ducted by an individual with appropriate expertise 

4 who was not involved in the initial determination. 

5 (2) PEER REVIEW OF MEDICAL DECISIONS BY

6 HEALTH CARE PROFESSIONALS.—A review of an ap7 peal of a denial of a claim for benefits that is based 

8 on a lack of medical necessity and appropriateness, 

9 or based on an experimental or investigational treat10 ment, or requires an evaluation of medical facts—

11 (A) shall be made by a physician 

12 (allopathic or osteopathic); or 

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

14 non-physician health professional, shall be made 

15 by reviewer (or reviewers) including at least one 

16 practicing non-physician health professional of 

17 the same or similar specialty; 

18 with appropriate expertise (including, in the case of 

19 a child, appropriate pediatric expertise) and acting 

20 within the appropriate scope of practice within the 

21 State in which the service is provided or rendered, 

22 who was not involved in the initial determination. 

23 (d) NOTICE OF DETERMINATION.—

24 (1) IN GENERAL.—Written notice of a deter25 mination made under an internal appeal of a denial 
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1 of a claim for benefits shall be issued to the partici2 pant, beneficiary, or enrollee (or authorized rep3 resentative) and the treating health care professional 

4 in accordance with the medical exigencies of the case 

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

6 2 days after the date of completion of the review (or, 

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

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

9 period referred to in such subparagraph). 

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

11 plan or issuer under this section shall be treated as 

12 the final determination of the plan or issuer on a de13 nial of a claim for benefits. The failure of a plan or 

14 issuer to issue a determination on an appeal of a de15 nial of a claim for benefits under this section within 

16 the applicable timeline established for such a deter17 mination shall be treated as a final determination on 

18 an appeal of a denial of a claim for benefits for pur19 poses of proceeding to external review under section 

20 104. 

21 (3) REQUIREMENTS OF NOTICE.—With respect 

22 to a determination made under this section, the no23 tice described in paragraph (1) shall be provided in 

24 printed form and written in a manner calculated to 
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•HR 4628 IH 

1 be understood by the participant, beneficiary, or en2 rollee and shall include—

3 (A) the specific reasons for the determina4 tion (including a summary of the clinical or sci5 entific evidence used in making the determina6 tion); 

7 (B) the procedures for obtaining additional 

8 information concerning the determination; and 

9 (C) notification of the right to an inde10 pendent external review under section 104 and 

11 instructions on how to initiate such a review. 

12 SEC. 104. INDEPENDENT EXTERNAL APPEALS PROCE13 DURES. 

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

15 plan, and a health insurance issuer offering health insur16 ance coverage, shall provide in accordance with this sec17 tion participants, beneficiaries, and enrollees (or author18 ized representatives) with access to an independent exter19 nal review for any denial of a claim for benefits. 

20 (b) INITIATION OF THE INDEPENDENT EXTERNAL

21 REVIEW PROCESS.—

22 (1) TIME TO FILE.—A request for an inde23 pendent external review under this section shall be 

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

25 after the date on which the participant, beneficiary, 
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•HR 4628 IH 

1 or enrollee receives notice of the denial under section 

2 103(d) or notice of waiver of internal review under 

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

4 issuer has failed to make a timely decision under 

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

6 beneficiary that it has failed to make a timely deci7 sion and that the beneficiary must file an appeal 

8 with an external review entity within 180 days if the 

9 participant or beneficiary desires to file such an ap10 peal. 

11 (2) FILING OF REQUEST.—

12 (A) IN GENERAL.—Subject to the suc13 ceeding provisions of this subsection, a group 

14 health plan, or health insurance issuer offering 

15 health insurance coverage, may—

16 (i) except as provided in subparagraph 

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

18 in writing; 

19 (ii) limit the filing of such a request 

20 to the participant, beneficiary, or enrollee 

21 involved (or an authorized representative); 

22 (iii) except if waived by the plan or 

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

24 access to an independent external review 

25 under this section upon a final determina-
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•HR 4628 IH 

1 tion of a denial of a claim for benefits 

2 under the internal review procedure under 

3 section 103; 

4 (iv) except as provided in subpara5 graph (B)(ii), require payment of a filing 

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

7 not exceed $25; and 

8 (v) require that a request for review 

9 include the consent of the participant, ben10 eficiary, or enrollee (or authorized rep11 resentative) for the release of necessary 

12 medical information or records of the par13 ticipant, beneficiary, or enrollee to the 

14 qualified external review entity only for 

15 purposes of conducting external review ac16 tivities. 

17 (B) REQUIREMENTS AND EXCEPTION RE18 LATING TO GENERAL RULE.—

19 (i) ORAL REQUESTS PERMITTED IN

20 EXPEDITED OR CONCURRENT CASES.—In 

21 the case of an expedited or concurrent ex22 ternal review as provided for under sub23 section (e), the request for such review 

24 may be made orally. A group health plan, 

25 or health insurance issuer offering health 
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•HR 4628 IH 

1 insurance coverage, may require that the 

2 participant, beneficiary, or enrollee (or au3 thorized representative) provide written 

4 confirmation of such request in a timely 

5 manner on a form provided by the plan or 

6 issuer. Such written confirmation shall be 

7 treated as a consent for purposes of sub8 paragraph (A)(v). In the case of such an 

9 oral request for such a review, the making 

10 of the request (and the timing of such re11 quest) shall be treated as the making at 

12 that time of a request for such a review 

13 without regard to whether and when a 

14 written confirmation of such request is 

15 made. 

16 (ii) EXCEPTION TO FILING FEE RE17 QUIREMENT.—

18 (I) INDIGENCY.—Payment of a 

19 filing fee shall not be required under 

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

21 certification (in a form and manner 

22 specified in guidelines established by 

23 the appropriate Secretary) that the 

24 participant, beneficiary, or enrollee is 
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•HR 4628 IH 

1 indigent (as defined in such guide2 lines). 

3 (II) FEE NOT REQUIRED.—Pay4 ment of a filing fee shall not be re5 quired under subparagraph (A)(iv) if 

6 the plan or issuer waives the internal 

7 appeals process under section 

8 103(a)(4). 

9 (III) REFUNDING OF FEE.—The 

10 filing fee paid under subparagraph 

11 (A)(iv) shall be refunded if the deter12 mination under the independent exter13 nal review is to reverse or modify the 

14 denial which is the subject of the re15 view. 

16 (IV) COLLECTION OF FILING

17 FEE.—The failure to pay such a filing 

18 fee shall not prevent the consideration 

19 of a request for review but, subject to 

20 the preceding provisions of this clause, 

21 shall constitute a legal liability to pay. 

22 (c) REFERRAL TO QUALIFIED EXTERNAL REVIEW

23 ENTITY UPON REQUEST.—

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

25 for independent external review with the group 
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•HR 4628 IH 

1 health plan, or health insurance issuer offering 

2 health insurance coverage, the plan or issuer shall 

3 immediately refer such request, and forward the 

4 plan or issuer’s initial decision (including the infor5 mation described in section 103(d)(3)(A)), to a 

6 qualified external review entity selected in accord7 ance with this section. 

8 (2) ACCESS TO PLAN OR ISSUER AND HEALTH

9 PROFESSIONAL INFORMATION.—With respect to an 

10 independent external review conducted under this 

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

12 authorized representative), the plan or issuer, and 

13 the treating health care professional (if any) shall 

14 provide the external review entity with information 

15 that is necessary to conduct a review under this sec16 tion, as determined and requested by the entity. 

17 Such information shall be provided not later than 5 

18 days after the date on which the request for infor19 mation is received, or, in a case described in clause 

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

21 time as may be necessary to comply with the appli22 cable timeline under such clause. 

23 (3) SCREENING OF REQUESTS BY QUALIFIED

24 EXTERNAL REVIEW ENTITIES.—
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•HR 4628 IH 

1 (A) IN GENERAL.—With respect to a re2 quest referred to a qualified external review en3 tity under paragraph (1) relating to a denial of 

4 a claim for benefits, the entity shall refer such 

5 request for the conduct of an independent med6 ical review unless the entity determines that—

7 (i) any of the conditions described in 

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

9 have not been met; 

10 (ii) the denial of the claim for benefits 

11 does not involve a medically reviewable de12 cision under subsection (d)(2); 

13 (iii) the denial of the claim for bene14 fits relates to a decision regarding whether 

15 an individual is a participant, beneficiary, 

16 or enrollee who is enrolled under the terms 

17 and conditions of the plan or coverage (in18 cluding the applicability of any waiting pe19 riod under the plan or coverage); or 

20 (iv) the denial of the claim for bene21 fits is a decision as to the application of 

22 cost-sharing requirements or the applica23 tion of a specific exclusion or express limi24 tation on the amount, duration, or scope of 

25 coverage of items or services under the 
32

•HR 4628 IH 

1 terms and conditions of the plan or cov2 erage unless the decision is a denial de3 scribed in subsection (d)(2). 

4 Upon making a determination that any of 

5 clauses (i) through (iv) applies with respect to 

6 the request, the entity shall determine that the 

7 denial of a claim for benefits involved is not eli8 gible for independent medical review under sub9 section (d), and shall provide notice in accord10 ance with subparagraph (C). 

11 (B) PROCESS FOR MAKING DETERMINA12 TIONS.—

13 (i) NO DEFERENCE TO PRIOR DETER14 MINATIONS.—In making determinations 

15 under subparagraph (A), there shall be no 

16 deference given to determinations made by 

17 the plan or issuer or the recommendation 

18 of a treating health care professional (if 

19 any). 

20 (ii) USE OF APPROPRIATE PER21 SONNEL.—A qualified external review enti22 ty shall use appropriately qualified per23 sonnel to make determinations under this 

24 section. 
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•HR 4628 IH 

1 (C) NOTICES AND GENERAL TIMELINES

2 FOR DETERMINATION.—

3 (i) NOTICE IN CASE OF DENIAL OF

4 REFERRAL.—If the entity under this para5 graph does not make a referral to an inde6 pendent medical reviewer, the entity shall 

7 provide notice to the plan or issuer, the 

8 participant, beneficiary, or enrollee (or au9 thorized representative) filing the request, 

10 and the treating health care professional 

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

12 independent medical review. Such notice—

13 (I) shall be written (and, in addi14 tion, may be provided orally) in a 

15 manner calculated to be understood 

16 by a participant or enrollee; 

17 (II) shall include the reasons for 

18 the determination; 

19 (III) include any relevant terms 

20 and conditions of the plan or cov21 erage; and 

22 (IV) include a description of any 

23 further recourse available to the indi24 vidual. 
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•HR 4628 IH 

1 (ii) GENERAL TIMELINE FOR DETER2 MINATIONS.—Upon receipt of information 

3 under paragraph (2), the qualified external 

4 review entity, and if required the inde5 pendent medical reviewer, shall make a de6 termination within the overall timeline that 

7 is applicable to the case under review as 

8 described in subsection (e), except that if 

9 the entity determines that a referral to an 

10 independent medical reviewer is not re11 quired, the entity shall provide notice of 

12 such determination to the participant, ben13 eficiary, or enrollee (or authorized rep14 resentative) within such timeline and with15 in 2 days of the date of such determina16 tion. 

17 (d) INDEPENDENT MEDICAL REVIEW.—

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

19 entity determines under subsection (c) that a denial 

20 of a claim for benefits is eligible for independent 

21 medical review, the entity shall refer the denial in22 volved to an independent medical reviewer for the 

23 conduct of an independent medical review under this 

24 subsection. 
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•HR 4628 IH 

1 (2) MEDICALLY REVIEWABLE DECISIONS.—A 

2 denial of a claim for benefits is eligible for inde3 pendent medical review if the benefit for the item or 

4 service for which the claim is made would be a cov5 ered benefit under the terms and conditions of the 

6 plan or coverage but for one (or more) of the fol7 lowing determinations: 

8 (A) DENIALS BASED ON MEDICAL NECES9 SITY AND APPROPRIATENESS.—A determination 

10 that the item or service is not covered because 

11 it is not medically necessary and appropriate or 

12 based on the application of substantially equiva13 lent terms. 

14 (B) DENIALS BASED ON EXPERIMENTAL

15 OR INVESTIGATIONAL TREATMENT.—A deter16 mination that the item or service is not covered 

17 because it is experimental or investigational or 

18 based on the application of substantially equiva19 lent terms. 

20 (C) DENIALS OTHERWISE BASED ON AN

21 EVALUATION OF MEDICAL FACTS.—A deter22 mination that the item or service or condition 

23 is not covered based on grounds that require an 

24 evaluation of the medical facts by a health care 

25 professional in the specific case involved to de-
36

•HR 4628 IH 

1 termine the coverage and extent of coverage of 

2 the item or service or condition. 

3 (3) INDEPENDENT MEDICAL REVIEW DETER4 MINATION.—

5 (A) IN GENERAL.—An independent med6 ical reviewer under this section shall make a 

7 new independent determination with respect to 

8 whether or not the denial of a claim for a ben9 efit that is the subject of the review should be 

10 upheld, reversed, or modified. 

11 (B) STANDARD FOR DETERMINATION.—

12 The independent medical reviewer’s determina13 tion relating to the medical necessity and ap14 propriateness, or the experimental or investiga15 tional nature, or the evaluation of the medical 

16 facts, of the item, service, or condition involved 

17 shall be based on the medical condition of the 

18 participant, beneficiary, or enrollee (including 

19 the medical records of the participant, bene20 ficiary, or enrollee) and valid, relevant scientific 

21 evidence and clinical evidence, including peer-re22 viewed medical literature or findings and in23 cluding expert opinion. 

24 (C) NO COVERAGE FOR EXCLUDED BENE25 FITS.—Nothing in this subsection shall be con-
37

•HR 4628 IH 

1 strued to permit an independent medical re2 viewer to require that a group health plan, or 

3 health insurance issuer offering health insur4 ance coverage, provide coverage for items or 

5 services for which benefits are specifically ex6 cluded or expressly limited under the plan or 

7 coverage in the plain language of the plan docu8 ment (and which are disclosed under section 

9 121(b)(1)(C)). Notwithstanding any other pro10 vision of this Act, any exclusion of an exact 

11 medical procedure, any exact time limit on the 

12 duration or frequency of coverage, and any 

13 exact dollar limit on the amount of coverage 

14 that is specifically enumerated and defined (in 

15 the plain language of the plan or coverage docu16 ments) under the plan or coverage offered by a 

17 group health plan or health insurance issuer of18 fering health insurance coverage and that is 

19 disclosed under section 121(b)(1) shall be con20 sidered to govern the scope of the benefits that 

21 may be required: Provided, That the terms and 

22 conditions of the plan or coverage relating to 

23 such an exclusion or limit are in compliance 

24 with the requirements of law. 
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•HR 4628 IH 

1 (D) EVIDENCE AND INFORMATION TO BE

2 USED IN MEDICAL REVIEWS.—In making a de3 termination under this subsection, the inde4 pendent medical reviewer shall also consider ap5 propriate and available evidence and informa6 tion, including the following: 

7 (i) The determination made by the 

8 plan or issuer with respect to the claim 

9 upon internal review and the evidence, 

10 guidelines, or rationale used by the plan or 

11 issuer in reaching such determination. 

12 (ii) The recommendation of the treat13 ing health care professional and the evi14 dence, guidelines, and rationale used by 

15 the treating health care professional in 

16 reaching such recommendation. 

17 (iii) Additional relevant evidence or 

18 information obtained by the reviewer or 

19 submitted by the plan, issuer, participant, 

20 beneficiary, or enrollee (or an authorized 

21 representative), or treating health care 

22 professional. 

23 (iv) The plan or coverage document. 

24 (E) INDEPENDENT DETERMINATION.—In 

25 making determinations under this section, a 
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•HR 4628 IH 

1 qualified external review entity and an inde2 pendent medical reviewer shall—

3 (i) consider the claim under review 

4 without deference to the determinations 

5 made by the plan or issuer or the rec6 ommendation of the treating health care 

7 professional (if any); and 

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

9 definition used by the plan or issuer of 

10 ‘‘medically necessary and appropriate’’, or 

11 ‘‘experimental or investigational’’, or other 

12 substantially equivalent terms that are 

13 used by the plan or issuer to describe med14 ical necessity and appropriateness or ex15 perimental or investigational nature of the 

16 treatment. 

17 (F) DETERMINATION OF INDEPENDENT

18 MEDICAL REVIEWER.—An independent medical 

19 reviewer shall, in accordance with the deadlines 

20 described in subsection (e), prepare a written 

21 determination to uphold, reverse, or modify the 

22 denial under review. Such written determination 

23 shall include—

24 (i) the determination of the reviewer; 
40

•HR 4628 IH 

1 (ii) the specific reasons of the re2 viewer for such determination, including a 

3 summary of the clinical or scientific evi4 dence used in making the determination; 

5 and 

6 (iii) with respect to a determination to 

7 reverse or modify the denial under review, 

8 a timeframe within which the plan or 

9 issuer must comply with such determina10 tion. 

11 (G) NONBINDING NATURE OF ADDITIONAL

12 RECOMMENDATIONS.—In addition to the deter13 mination under subparagraph (F), the reviewer 

14 may provide the plan or issuer and the treating 

15 health care professional with additional rec16 ommendations in connection with such a deter17 mination, but any such recommendations shall 

18 not affect (or be treated as part of) the deter19 mination and shall not be binding on the plan 

20 or issuer. 

21 (e) TIMELINES AND NOTIFICATIONS.—

22 (1) TIMELINES FOR INDEPENDENT MEDICAL

23 REVIEW.—

24 (A) PRIOR AUTHORIZATION DETERMINA25 TION.—
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•HR 4628 IH 

1 (i) IN GENERAL.—The independent 

2 medical reviewer (or reviewers) shall make 

3 a determination on a denial of a claim for 

4 benefits that is referred to the reviewer 

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

6 the medical exigencies of the case and as 

7 soon as possible, but in no case later than 

8 14 days after the date of receipt of infor9 mation under subsection (c)(2) if the re10 view involves a prior authorization of items 

11 or services and in no case later than 21 

12 days after the date the request for external 

13 review is received. 

14 (ii) EXPEDITED DETERMINATION.—

15 Notwithstanding clause (i) and subject to 

16 clause (iii), the independent medical re17 viewer (or reviewers) shall make an expe18 dited determination on a denial of a claim 

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

20 request for such an expedited determina21 tion is made by a participant, beneficiary, 

22 or enrollee (or authorized representative) 

23 at any time during the process for making 

24 a determination, and a health care profes25 sional certifies, with the request, that a de-
42

•HR 4628 IH 

1 termination under the timeline described in 

2 clause (i) would seriously jeopardize the 

3 life or health of the participant, bene4 ficiary, or enrollee or the ability of the par5 ticipant, beneficiary, or enrollee to main6 tain or regain maximum function. Such de7 termination shall be made in accordance 

8 with the medical exigencies of the case and 

9 as soon as possible, but in no case later 

10 than 72 hours after the time the request 

11 for external review is received by the quali12 fied external review entity. 

13 (iii) ONGOING CARE DETERMINA14 TION.—Notwithstanding clause (i), in the 

15 case of a review described in such clause 

16 that involves a termination or reduction of 

17 care, the notice of the determination shall 

18 be completed not later than 24 hours after 

19 the time the request for external review is 

20 received by the qualified external review 

21 entity and before the end of the approved 

22 period of care. 

23 (B) RETROSPECTIVE DETERMINATION.—

24 The independent medical reviewer (or review25 ers) shall complete a review in the case of a ret-
43

•HR 4628 IH 

1 rospective determination on an appeal of a de2 nial of a claim for benefits that is referred to 

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

4 later than 30 days after the date of receipt of 

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

6 case later than 60 days after the date the re7 quest for external review is received by the 

8 qualified external review entity. 

9 (2) NOTIFICATION OF DETERMINATION.—The 

10 external review entity shall ensure that the plan or 

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

12 authorized representative) and the treating health 

13 care professional (if any) receives a copy of the writ14 ten determination of the independent medical re15 viewer prepared under subsection (d)(3)(F). Nothing 

16 in this paragraph shall be construed as preventing 

17 an entity or reviewer from providing an initial oral 

18 notice of the reviewer’s determination. 

19 (3) FORM OF NOTICES.—Determinations and 

20 notices under this subsection shall be written in a 

21 manner calculated to be understood by a participant. 

22 (f) COMPLIANCE.—

23 (1) APPLICATION OF DETERMINATIONS.—

24 (A) EXTERNAL REVIEW DETERMINATIONS

25 BINDING ON PLAN.—The determinations of an 
44

•HR 4628 IH 

1 external review entity and an independent med2 ical reviewer under this section shall be binding 

3 upon the plan or issuer involved. 

4 (B) COMPLIANCE WITH DETERMINA5 TION.—If the determination of an independent 

6 medical reviewer is to reverse or modify the de7 nial, the plan or issuer, upon the receipt of such 

8 determination, shall authorize coverage to com9 ply with the medical reviewer’s determination in 

10 accordance with the timeframe established by 

11 the medical reviewer. 

12 (2) FAILURE TO COMPLY.—

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

14 to comply with the timeframe established under 

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

16 beneficiary, or enrollee, where such failure to 

17 comply is caused by the plan or issuer, the par18 ticipant, beneficiary, or enrollee may obtain the 

19 items or services involved (in a manner con20 sistent with the determination of the inde21 pendent external reviewer) from any provider 

22 regardless of whether such provider is a partici23 pating provider under the plan or coverage. 

24 (B) REIMBURSEMENT.—
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•HR 4628 IH 

1 (i) IN GENERAL.—Where a partici2 pant, beneficiary, or enrollee obtains items 

3 or services in accordance with subpara4 graph (A), the plan or issuer involved shall 

5 provide for reimbursement of the costs of 

6 such items or services. Such reimburse7 ment shall be made to the treating health 

8 care professional or to the participant, ben9 eficiary, or enrollee (in the case of a partic10 ipant, beneficiary, or enrollee who pays for 

11 the costs of such items or services). 

12 (ii) AMOUNT.—The plan or issuer 

13 shall fully reimburse a professional, partici14 pant, beneficiary, or enrollee under clause 

15 (i) for the total costs of the items or serv16 ices provided (regardless of any plan limi17 tations that may apply to the coverage of 

18 such items or services) so long as the items 

19 or services were provided in a manner con20 sistent with the determination of the inde21 pendent medical reviewer. 

22 (C) FAILURE TO REIMBURSE.—Where a 

23 plan or issuer fails to provide reimbursement to 

24 a professional, participant, beneficiary, or en25 rollee in accordance with this paragraph, the 
46

•HR 4628 IH 

1 professional, participant, beneficiary, or enrollee 

2 may commence a civil action (or utilize other 

3 remedies available under law) to recover only 

4 the amount of any such reimbursement that is 

5 owed by the plan or issuer and any necessary 

6 legal costs or expenses (including attorney’s 

7 fees) incurred in recovering such reimburse8 ment. 

9 (D) AVAILABLE REMEDIES.—The remedies 

10 provided under this paragraph are in addition 

11 to any other available remedies. 

12 (3) PENALTIES AGAINST AUTHORIZED OFFI13 CIALS FOR REFUSING TO AUTHORIZE THE DETER14 MINATION OF AN EXTERNAL REVIEW ENTITY.—

15 (A) MONETARY PENALTIES.—

16 (i) IN GENERAL.—In any case in 

17 which the determination of an external re18 view entity is not followed by a group 

19 health plan, or by a health insurance issuer 

20 offering health insurance coverage, any 

21 person who, acting in the capacity of au22 thorizing the benefit, causes such refusal 

23 may, in the discretion of a court of com24 petent jurisdiction, be liable to an ag25 grieved participant, beneficiary, or enrollee 
47

•HR 4628 IH 

1 for a civil penalty in an amount of up to 

2 $1,000 a day from the date on which the 

3 determination was transmitted to the plan 

4 or issuer by the external review entity until 

5 the date the refusal to provide the benefit 

6 is corrected. 

7 (ii) ADDITIONAL PENALTY FOR FAIL8 ING TO FOLLOW TIMELINE.—In any case 

9 in which treatment was not commenced by 

10 the plan in accordance with the determina11 tion of an independent external reviewer, 

12 the Secretary shall assess a civil penalty of 

13 $10,000 against the plan and the plan 

14 shall pay such penalty to the participant, 

15 beneficiary, or enrollee involved. 

16 (B) CEASE AND DESIST ORDER AND

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

18 described in subparagraph (A) brought by a 

19 participant, beneficiary, or enrollee with respect 

20 to a group health plan, or a health insurance 

21 issuer offering health insurance coverage, in 

22 which a plaintiff alleges that a person referred 

23 to in such subparagraph has taken an action re24 sulting in a refusal of a benefit determined by 

25 an external appeal entity to be covered, or has 
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•HR 4628 IH 

1 failed to take an action for which such person 

2 is responsible under the terms and conditions of 

3 the plan or coverage and which is necessary 

4 under the plan or coverage for authorizing a 

5 benefit, the court shall cause to be served on 

6 the defendant an order requiring the defend7 ant—

8 (i) to cease and desist from the al9 leged action or failure to act; and 

10 (ii) to pay to the plaintiff a reasonable 

11 attorney’s fee and other reasonable costs 

12 relating to the prosecution of the action on 

13 the charges on which the plaintiff prevails. 

14 (C) ADDITIONAL CIVIL PENALTIES.—

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

16 penalty imposed under subparagraph (A) 

17 or (B), the appropriate Secretary may as18 sess a civil penalty against a person acting 

19 in the capacity of authorizing a benefit de20 termined by an external review entity for 

21 one or more group health plans, or health 

22 insurance issuers offering health insurance 

23 coverage, for—

24 (I) any pattern or practice of re25 peated refusal to authorize a benefit 
49

•HR 4628 IH 

1 determined by an external appeal enti2 ty to be covered; or 

3 (II) any pattern or practice of re4 peated violations of the requirements 

5 of this section with respect to such 

6 plan or coverage. 

7 (ii) STANDARD OF PROOF AND

8 AMOUNT OF PENALTY.—Such penalty shall 

9 be payable only upon proof by clear and 

10 convincing evidence of such pattern or 

11 practice and shall be in an amount not to 

12 exceed the lesser of—

13 (I) 25 percent of the aggregate 

14 value of benefits shown by the appro15 priate Secretary to have not been pro16 vided, or unlawfully delayed, in viola17 tion of this section under such pattern 

18 or practice; or 

19 (II) $500,000. 

20 (D) REMOVAL AND DISQUALIFICATION.—

21 Any person acting in the capacity of author22 izing benefits who has engaged in any such pat23 tern or practice described in subparagraph 

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

25 the petition of the appropriate Secretary, may 
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•HR 4628 IH 

1 be removed by the court from such position, 

2 and from any other involvement, with respect to 

3 such a plan or coverage, and may be precluded 

4 from returning to any such position or involve5 ment for a period determined by the court. 

6 (4) PROTECTION OF LEGAL RIGHTS.—Nothing 

7 in this subsection or subtitle shall be construed as 

8 altering or eliminating any cause of action or legal 

9 rights or remedies of participants, beneficiaries, en10 rollees, and others under State or Federal law (in11 cluding sections 502 and 503 of the Employee Re12 tirement Income Security Act of 1974), including 

13 the right to file judicial actions to enforce rights. 

14 (g) QUALIFICATIONS OF INDEPENDENT MEDICAL

15 REVIEWERS.—

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

17 more individuals to conduct independent medical re18 view under subsection (c), the qualified external re19 view entity shall ensure that—

20 (A) each independent medical reviewer 

21 meets the qualifications described in paragraphs 

22 (2) and (3); 

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

24 such reviewer meets the requirements described 

25 in paragraphs (4) and (5); and 
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•HR 4628 IH 

1 (C) compensation provided by the entity to 

2 the reviewer is consistent with paragraph (6). 

3 (2) LICENSURE AND EXPERTISE.—Each inde4 pendent medical reviewer shall be a physician 

5 (allopathic or osteopathic) or health care profes6 sional who—

7 (A) is appropriately credentialed or li8 censed in 1 or more States to deliver health 

9 care services; and 

10 (B) typically treats the condition, makes 

11 the diagnosis, or provides the type of treatment 

12 under review. 

13 (3) INDEPENDENCE.—

14 (A) IN GENERAL.—Subject to subpara15 graph (B), each independent medical reviewer 

16 in a case shall—

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

18 in paragraph (7)); 

19 (ii) not have a material familial, fi20 nancial, or professional relationship with 

21 such a party; and 

22 (iii) not otherwise have a conflict of 

23 interest with such a party (as determined 

24 under regulations). 
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•HR 4628 IH 

1 (B) EXCEPTION.—Nothing in subpara2 graph (A) shall be construed to—

3 (i) prohibit an individual, solely on the 

4 basis of affiliation with the plan or issuer, 

5 from serving as an independent medical re6 viewer if—

7 (I) a non-affiliated individual is 

8 not reasonably available; 

9 (II) the affiliated individual is 

10 not involved in the provision of items 

11 or services in the case under review; 

12 (III) the fact of such an affili13 ation is disclosed to the plan or issuer 

14 and the participant, beneficiary, or 

15 enrollee (or authorized representative) 

16 and neither party objects; and 

17 (IV) the affiliated individual is 

18 not an employee of the plan or issuer 

19 and does not provide services exclu20 sively or primarily to or on behalf of 

21 the plan or issuer; 

22 (ii) prohibit an individual who has 

23 staff privileges at the institution where the 

24 treatment involved takes place from serv25 ing as an independent medical reviewer 
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1 merely on the basis of such affiliation if 

2 the affiliation is disclosed to the plan or 

3 issuer and the participant, beneficiary, or 

4 enrollee (or authorized representative), and 

5 neither party objects; or 

6 (iii) prohibit receipt of compensation 

7 by an independent medical reviewer from 

8 an entity if the compensation is provided 

9 consistent with paragraph (6). 

10 (4) PRACTICING HEALTH CARE PROFESSIONAL

11 IN SAME FIELD.—

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

13 treatment, or the provision of items or serv14 ices—

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

16 a practicing physician (allopathic or osteo17 pathic) of the same or similar specialty, as 

18 a physician who, acting within the appro19 priate scope of practice within the State in 

20 which the service is provided or rendered, 

21 typically treats the condition, makes the 

22 diagnosis, or provides the type of treat23 ment under review; or 

24 (ii) by a non-physician health care 

25 professional, a reviewer (or reviewers) shall 
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1 include at least one practicing non-physi2 cian health care professional of the same 

3 or similar specialty as the non-physician 

4 health care professional who, acting within 

5 the appropriate scope of practice within 

6 the State in which the service is provided 

7 or rendered, typically treats the condition, 

8 makes the diagnosis, or provides the type 

9 of treatment under review. 

10 (B) PRACTICING DEFINED.—For purposes 

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

12 with respect to an individual who is a physician 

13 or other health care professional that the indi14 vidual provides health care services to individual 

15 patients on average at least 2 days per week. 

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

17 external review relating to a child, a reviewer shall 

18 have expertise under paragraph (2) in pediatrics. 

19 (6) LIMITATIONS ON REVIEWER COMPENSA20 TION.—Compensation provided by a qualified exter21 nal review entity to an independent medical reviewer 

22 in connection with a review under this section 

23 shall—

24 (A) not exceed a reasonable level; and 
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1 (B) not be contingent on the decision ren2 dered by the reviewer. 

3 (7) RELATED PARTY DEFINED.—For purposes 

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

5 respect to a denial of a claim under a plan or cov6 erage relating to a participant, beneficiary, or en7 rollee, any of the following: 

8 (A) The plan, plan sponsor, or issuer in9 volved, or any fiduciary, officer, director, or em10 ployee of such plan, plan sponsor, or issuer. 

11 (B) The participant, beneficiary, or en12 rollee (or authorized representative). 

13 (C) The health care professional that pro14 vides the items or services involved in the de15 nial. 

16 (D) The institution at which the items or 

17 services (or treatment) involved in the denial 

18 are provided. 

19 (E) The manufacturer of any drug or 

20 other item that is included in the items or serv21 ices involved in the denial. 

22 (F) Any other party determined under any 

23 regulations to have a substantial interest in the 

24 denial involved. 

25 (h) QUALIFIED EXTERNAL REVIEW ENTITIES.—
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1 (1) SELECTION OF QUALIFIED EXTERNAL RE2 VIEW ENTITIES.—

3 (A) LIMITATION ON PLAN OR ISSUER SE4 LECTION.—The appropriate Secretary shall im5 plement procedures—

6 (i) to assure that the selection process 

7 among qualified external review entities 

8 will not create any incentives for external 

9 review entities to make a decision in a bi10 ased manner; and 

11 (ii) for auditing a sample of decisions 

12 by such entities to assure that no such de13 cisions are made in a biased manner. 

14 No such selection process under the procedures 

15 implemented by the appropriate Secretary may 

16 give either the patient or the plan or issuer any 

17 ability to determine or influence the selection of 

18 a qualified external review entity to review the 

19 case of any participant, beneficiary, or enrollee. 

20 (B) STATE AUTHORITY WITH RESPECT TO

21 QUALIFIED EXTERNAL REVIEW ENTITIES FOR

22 HEALTH INSURANCE ISSUERS.—With respect to 

23 health insurance issuers offering health insur24 ance coverage in a State, the State may provide 

25 for external review activities to be conducted by 
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1 a qualified external appeal entity that is des2 ignated by the State or that is selected by the 

3 State in a manner determined by the State to 

4 assure an unbiased determination. 

5 (2) CONTRACT WITH QUALIFIED EXTERNAL RE6 VIEW ENTITY.—Except as provided in paragraph 

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

8 issuer under this section shall be conducted under a 

9 contract between the plan or issuer and 1 or more 

10 qualified external review entities (as defined in para11 graph (4)(A)). 

12 (3) TERMS AND CONDITIONS OF CONTRACT.—

13 The terms and conditions of a contract under para14 graph (2) shall—

15 (A) be consistent with the standards the 

16 appropriate Secretary shall establish to assure 

17 there is no real or apparent conflict of interest 

18 in the conduct of external review activities; and 

19 (B) provide that the costs of the external 

20 review process shall be borne by the plan or 

21 issuer. 

22 Subparagraph (B) shall not be construed as apply23 ing to the imposition of a filing fee under subsection 

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

25 beneficiary, or enrollee (or authorized representative) 
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1 or treating health care professional (if any) in sup2 port of the review, including the provision of addi3 tional evidence or information. 

4 (4) QUALIFICATIONS.—

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

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

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

8 initially certified (and periodically recertified) 

9 under subparagraph (C) as meeting the fol10 lowing requirements: 

11 (i) The entity has (directly or through 

12 contracts or other arrangements) sufficient 

13 medical, legal, and other expertise and suf14 ficient staffing to carry out duties of a 

15 qualified external review entity under this 

16 section on a timely basis, including making 

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

18 and providing for independent medical re19 views under subsection (d). 

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

21 or an affiliate or a subsidiary of a plan or 

22 issuer, and is not an affiliate or subsidiary 

23 of a professional or trade association of 

24 plans or issuers or of health care providers. 
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1 (iii) The entity has provided assur2 ances that it will conduct external review 

3 activities consistent with the applicable re4 quirements of this section and standards 

5 specified in subparagraph (C), including 

6 that it will not conduct any external review 

7 activities in a case unless the independence 

8 requirements of subparagraph (B) are met 

9 with respect to the case. 

10 (iv) The entity has provided assur11 ances that it will provide information in a 

12 timely manner under subparagraph (D). 

13 (v) The entity meets such other re14 quirements as the appropriate Secretary 

15 provides by regulation. 

16 (B) INDEPENDENCE REQUIREMENTS.—

17 (i) IN GENERAL.—Subject to clause 

18 (ii), an entity meets the independence re19 quirements of this subparagraph with re20 spect to any case if the entity—

21 (I) is not a related party (as de22 fined in subsection (g)(7)); 

23 (II) does not have a material fa24 milial, financial, or professional rela25 tionship with such a party; and 
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1 (III) does not otherwise have a 

2 conflict of interest with such a party 

3 (as determined under regulations). 

4 (ii) EXCEPTION FOR REASONABLE

5 COMPENSATION.—Nothing in clause (i) 

6 shall be construed to prohibit receipt by a 

7 qualified external review entity of com8 pensation from a plan or issuer for the 

9 conduct of external review activities under 

10 this section if the compensation is provided 

11 consistent with clause (iii). 

12 (iii) LIMITATIONS ON ENTITY COM13 PENSATION.—Compensation provided by a 

14 plan or issuer to a qualified external review 

15 entity in connection with reviews under 

16 this section shall—

17 (I) not exceed a reasonable level; 

18 and 

19 (II) not be contingent on any de20 cision rendered by the entity or by 

21 any independent medical reviewer. 

22 (C) CERTIFICATION AND RECERTIFICATION

23 PROCESS.—
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1 (i) IN GENERAL.—The initial certifi2 cation and recertification of a qualified ex3 ternal review entity shall be made—

4 (I) under a process that is recog5 nized or approved by the appropriate 

6 Secretary; or 

7 (II) by a qualified private stand8 ard-setting organization that is ap9 proved by the appropriate Secretary 

10 under clause (iii). 

11 In taking action under subclause (I), the 

12 appropriate Secretary shall give deference 

13 to entities that are under contract with the 

14 Federal Government or with an applicable 

15 State authority to perform functions of the 

16 type performed by qualified external review 

17 entities. 

18 (ii) PROCESS.—The appropriate Sec19 retary shall not recognize or approve a 

20 process under clause (i)(I) unless the proc21 ess applies standards (as promulgated in 

22 regulations) that ensure that a qualified 

23 external review entity—

24 (I) will carry out (and has car25 ried out, in the case of recertification) 
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1 the responsibilities of such an entity 

2 in accordance with this section, in3 cluding meeting applicable deadlines; 

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

5 the case of recertification) appropriate 

6 indicators of fiscal integrity; 

7 (III) will maintain (and has 

8 maintained, in the case of recertifi9 cation) appropriate confidentiality 

10 with respect to individually identifi11 able health information obtained in 

12 the course of conducting external re13 view activities; and 

14 (IV) in the case of recertification, 

15 shall review the matters described in 

16 clause (iv). 

17 (iii) APPROVAL OF QUALIFIED PRI18 VATE STANDARD-SETTING ORGANIZA19 TIONS.—For purposes of clause (i)(II), the 

20 appropriate Secretary may approve a quali21 fied private standard-setting organization 

22 if such Secretary finds that the organiza23 tion only certifies (or recertifies) external 

24 review entities that meet at least the 

25 standards required for the certification (or 
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1 recertification) of external review entities 

2 under clause (ii). 

3 (iv) CONSIDERATIONS IN RECERTIFI4 CATIONS.—In conducting recertifications of 

5 a qualified external review entity under 

6 this paragraph, the appropriate Secretary 

7 or organization conducting the recertifi8 cation shall review compliance of the entity 

9 with the requirements for conducting ex10 ternal review activities under this section, 

11 including the following: 

12 (I) Provision of information 

13 under subparagraph (D). 

14 (II) Adherence to applicable 

15 deadlines (both by the entity and by 

16 independent medical reviewers it re17 fers cases to). 

18 (III) Compliance with limitations 

19 on compensation (with respect to both 

20 the entity and independent medical re21 viewers it refers cases to). 

22 (IV) Compliance with applicable 

23 independence requirements. 

24 (V) Compliance with the require25 ment of subsection (d)(1) that only 
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1 medically reviewable decisions shall be 

2 the subject of independent medical re3 view and with the requirement of sub4 section (d)(3) that independent med5 ical reviewers may not require cov6 erage for specifically excluded bene7 fits. 

8 (v) PERIOD OF CERTIFICATION OR RE9 CERTIFICATION.—A certification or recer10 tification provided under this paragraph 

11 shall extend for a period not to exceed 2 

12 years. 

13 (vi) REVOCATION.—A certification or 

14 recertification under this paragraph may 

15 be revoked by the appropriate Secretary or 

16 by the organization providing such certifi17 cation upon a showing of cause. The Sec18 retary, or organization, shall revoke a cer19 tification or deny a recertification with re20 spect to an entity if there is a showing that 

21 the entity has a pattern or practice of or22 dering coverage for benefits that are spe23 cifically excluded under the plan or cov24 erage. 
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1 (vii) PETITION FOR DENIAL OR WITH2 DRAWAL.—An individual may petition the 

3 Secretary, or an organization providing the 

4 certification involves, for a denial of recer5 tification or a withdrawal of a certification 

6 with respect to an entity under this sub7 paragraph if there is a pattern or practice 

8 of such entity failing to meet a require9 ment of this section. 

10 (viii) SUFFICIENT NUMBER OF ENTI11 TIES.—The appropriate Secretary shall 

12 certify and recertify a number of external 

13 review entities which is sufficient to ensure 

14 the timely and efficient provision of review 

15 services. 

16 (D) PROVISION OF INFORMATION.—

17 (i) IN GENERAL.—A qualified external 

18 review entity shall provide to the appro19 priate Secretary, in such manner and at 

20 such times as such Secretary may require, 

21 such information (relating to the denials 

22 which have been referred to the entity for 

23 the conduct of external review under this 

24 section) as such Secretary determines ap25 propriate to assure compliance with the 
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1 independence and other requirements of 

2 this section to monitor and assess the qual3 ity of its external review activities and lack 

4 of bias in making determinations. Such in5 formation shall include information de6 scribed in clause (ii) but shall not include 

7 individually identifiable medical informa8 tion. 

9 (ii) INFORMATION TO BE IN10 CLUDED.—The information described in 

11 this subclause with respect to an entity is 

12 as follows: 

13 (I) The number and types of de14 nials for which a request for review 

15 has been received by the entity. 

16 (II) The disposition by the entity 

17 of such denials, including the number 

18 referred to a independent medical re19 viewer and the reasons for such dis20 positions (including the application of 

21 exclusions), on a plan or issuer-spe22 cific basis and on a health care spe23 cialty-specific basis. 
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1 (III) The length of time in mak2 ing determinations with respect to 

3 such denials. 

4 (IV) Updated information on the 

5 information required to be submitted 

6 as a condition of certification with re7 spect to the entity’s performance of 

8 external review activities. 

9 (iii) INFORMATION TO BE PROVIDED

10 TO CERTIFYING ORGANIZATION.—

11 (I) IN GENERAL.—In the case of 

12 a qualified external review entity 

13 which is certified (or recertified) 

14 under this subsection by a qualified 

15 private standard-setting organization, 

16 at the request of the organization, the 

17 entity shall provide the organization 

18 with the information provided to the 

19 appropriate Secretary under clause 

20 (i). 

21 (II) ADDITIONAL INFORMA22 TION.—Nothing in this subparagraph 

23 shall be construed as preventing such 

24 an organization from requiring addi25 tional information as a condition of 
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1 certification or recertification of an 

2 entity. 

3 (iv) USE OF INFORMATION.—Informa4 tion provided under this subparagraph may 

5 be used by the appropriate Secretary and 

6 qualified private standard-setting organiza7 tions to conduct oversight of qualified ex8 ternal review entities, including recertifi9 cation of such entities, and shall be made 

10 available to the public in an appropriate 

11 manner. 

12 (E) LIMITATION ON LIABILITY.—No quali13 fied external review entity having a contract 

14 with a plan or issuer, and no person who is em15 ployed by any such entity or who furnishes pro16 fessional services to such entity (including as an 

17 independent medical reviewer), shall be held by 

18 reason of the performance of any duty, func19 tion, or activity required or authorized pursuant 

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

21 of the United States or of any State (or polit22 ical subdivision thereof) if there was no actual 

23 malice or gross misconduct in the performance 

24 of such duty, function, or activity. 
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1 (5) REPORT.—Not later than 12 months after 

2 the general effective date referred to in section 601, 

3 the General Accounting Office shall prepare and 

4 submit to the appropriate committees of Congress a 

5 report concerning—

6 (A) the information that is provided under 

7 paragraph (3)(D); 

8 (B) the number of denials that have been 

9 upheld by independent medical reviewers and 

10 the number of denials that have been reversed 

11 by such reviewers; and 

12 (C) the extent to which independent med13 ical reviewers are requiring coverage for bene14 fits that are specifically excluded under the plan 

15 or coverage. 

16 SEC. 105. HEALTH CARE CONSUMER ASSISTANCE FUND. 

17 (a) GRANTS.—

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

19 Human Services (referred to in this section as the 

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

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

22 used to award grants to eligible States to carry out 

23 consumer assistance activities (including programs 

24 established by States prior to the enactment of this 
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1 Act) designed to provide information, assistance, and 

2 referrals to consumers of health insurance products. 

3 (2) STATE ELIGIBILITY.—To be eligible to re4 ceive a grant under this subsection a State shall pre5 pare and submit to the Secretary an application at 

6 such time, in such manner, and containing such in7 formation as the Secretary may require, including a 

8 State plan that describes—

9 (A) the manner in which the State will en10 sure that the health care consumer assistance 

11 office (established under paragraph (4)) will 

12 educate and assist health care consumers in ac13 cessing needed care; 

14 (B) the manner in which the State will co15 ordinate and distinguish the services provided 

16 by the health care consumer assistance office 

17 with the services provided by Federal, State and 

18 local health-related ombudsman, information, 

19 protection and advocacy, insurance, and fraud 

20 and abuse programs; 

21 (C) the manner in which the State will 

22 provide information, outreach, and services to 

23 underserved, minority populations with limited 

24 English proficiency and populations residing in 

25 rural areas; 
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1 (D) the manner in which the State will 

2 oversee the health care consumer assistance of3 fice, its activities, product materials and evalu4 ate program effectiveness; 

5 (E) the manner in which the State will en6 sure that funds made available under this sec7 tion will be used to supplement, and not sup8 plant, any other Federal, State, or local funds 

9 expended to provide services for programs de10 scribed under this section and those described 

11 in subparagraphs (C) and (D); 

12 (F) the manner in which the State will en13 sure that health care consumer office personnel 

14 have the professional background and training 

15 to carry out the activities of the office; and 

16 (G) the manner in which the State will en17 sure that consumers have direct access to con18 sumer assistance personnel during regular busi19 ness hours. 

20 (3) AMOUNT OF GRANT.—

21 (A) IN GENERAL.—From amounts appro22 priated under subsection (b) for a fiscal year, 

23 the Secretary shall award a grant to a State in 

24 an amount that bears the same ratio to such 

25 amounts as the number of individuals within 
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1 the State covered under a group health plan or 

2 under health insurance coverage offered by a 

3 health insurance issuer bears to the total num4 ber of individuals so covered in all States (as 

5 determined by the Secretary). Any amounts 

6 provided to a State under this subsection that 

7 are not used by the State shall be remitted to 

8 the Secretary and reallocated in accordance 

9 with this subparagraph. 

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

11 the amount provided to a State under a grant 

12 under this subsection for a fiscal year be less 

13 than an amount equal to 0.5 percent of the 

14 amount appropriated for such fiscal year to 

15 carry out this section. 

16 (C) NON-FEDERAL CONTRIBUTIONS.—A 

17 State will provide for the collection of non-Fed18 eral contributions for the operation of the office 

19 in an amount that is not less than 25 percent 

20 of the amount of Federal funds provided to the 

21 State under this section. 

22 (4) PROVISION OF FUNDS FOR ESTABLISHMENT

23 OF OFFICE.—

24 (A) IN GENERAL.—From amounts pro25 vided under a grant under this subsection, a 
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1 State shall, directly or through a contract with 

2 an independent, nonprofit entity with dem3 onstrated experience in serving the needs of 

4 health care consumers, provide for the estab5 lishment and operation of a State health care 

6 consumer assistance office. 

7 (B) ELIGIBILITY OF ENTITY.—To be eligi8 ble to enter into a contract under subparagraph 

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

10 technical, organizational, and professional ca11 pacity to deliver the services described in sub12 section (b) to all public and private health in13 surance participants, beneficiaries, enrollees, or 

14 prospective enrollees. 

15 (C) EXISTING STATE ENTITY.—Nothing in 

16 this section shall prevent the funding of an ex17 isting health care consumer assistance program 

18 that otherwise meets the requirements of this 

19 section. 

20 (b) USE OF FUNDS.—

21 (1) BY STATE.—A State shall use amounts pro22 vided under a grant awarded under this section to 

23 carry out consumer assistance activities directly or 

24 by contract with an independent, non-profit organi25 zation. An eligible entity may use some reasonable 
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1 amount of such grant to ensure the adequate train2 ing of personnel carrying out such activities. To re3 ceive amounts under this subsection, an eligible enti4 ty shall provide consumer assistance services, includ5 ing—

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

7 hotline to respond to consumer requests; 

8 (B) the dissemination of appropriate edu9 cational materials on available health insurance 

10 products and on how best to access health care 

11 and the rights and responsibilities of health 

12 care consumers; 

13 (C) the provision of education on effective 

14 methods to promptly and efficiently resolve 

15 questions, problems, and grievances; 

16 (D) the coordination of educational and 

17 outreach efforts with health plans, health care 

18 providers, payers, and governmental agencies; 

19 (E) referrals to appropriate private and 

20 public entities to resolve questions, problems 

21 and grievances; and 

22 (F) the provision of information and as23 sistance, including acting as an authorized rep24 resentative, regarding internal, external, or ad25 ministrative grievances or appeals procedures in 
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1 nonlitigative settings to appeal the denial, ter2 mination, or reduction of health care services, 

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

4 group health plan or health insurance coverage 

5 offered by a health insurance issuer. 

6 (2) CONFIDENTIALITY AND ACCESS TO INFOR7 MATION.—

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

9 State that directly establishes a health care con10 sumer assistance office, such office shall estab11 lish and implement procedures and protocols in 

12 accordance with applicable Federal and State 

13 laws. 

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

15 State that, through contract, establishes a 

16 health care consumer assistance office, such of17 fice shall establish and implement procedures 

18 and protocols, consistent with applicable Fed19 eral and State laws, to ensure the confiden20 tiality of all information shared by a partici21 pant, beneficiary, enrollee, or their personal 

22 representative and their health care providers, 

23 group health plans, or health insurance insurers 

24 with the office and to ensure that no such infor25 mation is used by the office, or released or dis-
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1 closed to State agencies or outside persons or 

2 entities without the prior written authorization 

3 (in accordance with section 164.508 of title 45, 

4 Code of Federal Regulations) of the individual 

5 or personal representative. The office may, con6 sistent with applicable Federal and State con7 fidentiality laws, collect, use or disclose aggre8 gate information that is not individually identi9 fiable (as defined in section 164.501 of title 45, 

10 Code of Federal Regulations). The office shall 

11 provide a written description of the policies and 

12 procedures of the office with respect to the 

13 manner in which health information may be 

14 used or disclosed to carry out consumer assist15 ance activities. The office shall provide health 

16 care providers, group health plans, or health in17 surance issuers with a written authorization (in 

18 accordance with section 164.508 of title 45, 

19 Code of Federal Regulations) to allow the office 

20 to obtain medical information relevant to the 

21 matter before the office. 

22 (3) AVAILABILITY OF SERVICES.—The health 

23 care consumer assistance office of a State shall not 

24 discriminate in the provision of information, refer25 rals, and services regardless of the source of the in-
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1 dividual’s health insurance coverage or prospective 

2 coverage, including individuals covered under a 

3 group health plan or health insurance coverage of4 fered by a health insurance issuer, the medicare or 

5 medicaid programs under title XVIII or XIX of the 

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

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

8 care program. 

9 (4) DESIGNATION OF RESPONSIBILITIES.—

10 (A) WITHIN EXISTING STATE ENTITY.—If 

11 the health care consumer assistance office of a 

12 State is located within an existing State regu13 latory agency or office of an elected State offi14 cial, the State shall ensure that—

15 (i) there is a separate delineation of 

16 the funding, activities, and responsibilities 

17 of the office as compared to the other 

18 funding, activities, and responsibilities of 

19 the agency; and 

20 (ii) the office establishes and imple21 ments procedures and protocols to ensure 

22 the confidentiality of all information 

23 shared by a participant, beneficiary, or en24 rollee or their personal representative and 

25 their health care providers, group health 
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1 plans, or health insurance issuers with the 

2 office and to ensure that no information is 

3 disclosed to the State agency or office 

4 without the written authorization of the in5 dividual or their personal representative in 

6 accordance with paragraph (2). 

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

8 entity that enters into a contract with a State 

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

10 assurances that the entity has no conflict of in11 terest in carrying out the activities of the office 

12 and that the entity is independent of group 

13 health plans, health insurance issuers, pro14 viders, payers, and regulators of health care. 

15 (5) SUBCONTRACTS.—The health care con16 sumer assistance office of a State may carry out ac17 tivities and provide services through contracts en18 tered into with 1 or more nonprofit entities so long 

19 as the office can demonstrate that all of the require20 ments of this section are complied with by the office. 

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

22 subsection shall be for a term of 3 years. 

23 (c) REPORT.—Not later than 1 year after the Sec24 retary first awards grants under this section, and annually 

25 thereafter, the Secretary shall prepare and submit to the 
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1 appropriate committees of Congress a report concerning 

2 the activities funded under this section and the effective3 ness of such activities in resolving health care-related 

4 problems and grievances. 

5 (d) AUTHORIZATION OF APPROPRIATIONS.—There 

6 are authorized to be appropriated such sums as may be 

7 necessary to carry out this section. 

8 Subtitle B—Access to Care 

9 SEC. 111. CONSUMER CHOICE OPTION. 

10 (a) IN GENERAL.—If—

11 (1) a health insurance issuer providing health 

12 insurance coverage in connection with a group health 

13 plan offers to enrollees health insurance coverage 

14 which provides for coverage of services (including 

15 physician pathology services) only if such services 

16 are furnished through health care professionals and 

17 providers who are members of a network of health 

18 care professionals and providers who have entered 

19 into a contract with the issuer to provide such serv20 ices, or 

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

22 beneficiaries health benefits which provide for cov23 erage of services only if such services are furnished 

24 through health care professionals and providers who 

25 are members of a network of health care profes-
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1 sionals and providers who have entered into a con2 tract with the plan to provide such services, 

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

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

5 the time of enrollment and during an annual open season 

6 as provided under subsection (c)) the option of health in7 surance coverage or health benefits which provide for cov8 erage of such services which are not furnished through 

9 health care professionals and providers who are members 

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

11 beneficiaries are offered such non-network coverage 

12 through another group health plan or through another 

13 health insurance issuer in the group market. 

14 (b) ADDITIONAL COSTS.—The amount of any addi15 tional premium charged by the health insurance issuer or 

16 group health plan for the additional cost of the creation 

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

18 and the amount of any additional cost sharing imposed 

19 under such option shall be borne by the enrollee, partici20 pant, or beneficiary unless it is paid by the health plan 

21 sponsor or group health plan through agreement with the 

22 health insurance issuer. 

23 (c) OPEN SEASON.—An enrollee, participant, or ben24 eficiary, may change to the offering provided under this 

25 section only during a time period determined by the health 
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1 insurance issuer or group health plan. Such time period 

2 shall occur at least annually. 

3 SEC. 112. CHOICE OF HEALTH CARE PROFESSIONAL. 

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

5 health insurance issuer that offers health insurance cov6 erage, requires or provides for designation by a partici7 pant, beneficiary, or enrollee of a participating primary 

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

9 participant, beneficiary, and enrollee to designate any par10 ticipating primary care provider who is available to accept 

11 such individual. 

12 (b) SPECIALISTS.—

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

14 group health plan and a health insurance issuer that 

15 offers health insurance coverage shall permit each 

16 participant, beneficiary, or enrollee to receive medi17 cally necessary and appropriate specialty care, pur18 suant to appropriate referral procedures, from any 

19 qualified participating health care professional who 

20 is available to accept such individual for such care. 

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

22 apply to specialty care if the plan or issuer clearly 

23 informs participants, beneficiaries, and enrollees of 

24 the limitations on choice of participating health care 

25 professionals with respect to such care. 
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1 (3) CONSTRUCTION.—Nothing in this sub2 section shall be construed as affecting the applica3 tion of section 114 (relating to access to specialty 

4 care). 

5 SEC. 113. ACCESS TO EMERGENCY CARE. 

6 (a) COVERAGE OF EMERGENCY SERVICES.—

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

8 health insurance coverage offered by a health insur9 ance issuer, provides or covers any benefits with re10 spect to services in an emergency department of a 

11 hospital, the plan or issuer shall cover emergency 

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

13 (A) without the need for any prior author14 ization determination; 

15 (B) whether the health care provider fur16 nishing such services is a participating provider 

17 with respect to such services; 

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

19 are provided to a participant, beneficiary, or en20 rollee—

21 (i) by a nonparticipating health care 

22 provider with or without prior authoriza23 tion, or 

24 (ii) by a participating health care pro25 vider without prior authorization, 
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1 the participant, beneficiary, or enrollee is not 

2 liable for amounts that exceed the amounts of 

3 liability that would be incurred if the services 

4 were provided by a participating health care 

5 provider with prior authorization; and 

6 (D) without regard to any other term or 

7 condition of such coverage (other than exclusion 

8 or coordination of benefits, or an affiliation or 

9 waiting period, permitted under section 2701 of 

10 the Public Health Service Act, section 701 of 

11 the Employee Retirement Income Security Act 

12 of 1974, or section 9801 of the Internal Rev13 enue Code of 1986, and other than applicable 

14 cost-sharing). 

15 (2) DEFINITIONS.—In this section: 

16 (A) EMERGENCY MEDICAL CONDITION.—

17 The term ‘‘emergency medical condition’’ means 

18 a medical condition manifesting itself by acute 

19 symptoms of sufficient severity (including se20 vere pain) such that a prudent layperson, who 

21 possesses an average knowledge of health and 

22 medicine, could reasonably expect the absence 

23 of immediate medical attention to result in a 

24 condition described in clause (i), (ii), or (iii) of 
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1 section 1867(e)(1)(A) of the Social Security 

2 Act. 

3 (B) EMERGENCY SERVICES.—The term 

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

5 emergency medical condition—

6 (i) a medical screening examination 

7 (as required under section 1867 of the So8 cial Security Act) that is within the capa9 bility of the emergency department of a 

10 hospital, including ancillary services rou11 tinely available to the emergency depart12 ment to evaluate such emergency medical 

13 condition, and 

14 (ii) within the capabilities of the staff 

15 and facilities available at the hospital, such 

16 further medical examination and treatment 

17 as are required under section 1867 of such 

18 Act to stabilize the patient. 

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

20 with respect to an emergency medical condition 

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

22 meaning given in section 1867(e)(3) of the So23 cial Security Act (42 U.S.C. 1395dd(e)(3)). 

24 (b) REIMBURSEMENT FOR MAINTENANCE CARE AND

25 POST-STABILIZATION CARE.—A group health plan, and 
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1 health insurance coverage offered by a health insurance 

2 issuer, must provide reimbursement for maintenance care 

3 and post-stabilization care in accordance with the require4 ments of section 1852(d)(2) of the Social Security Act (42 

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

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

7 (c) COVERAGE OF EMERGENCY AMBULANCE SERV8 ICES.—

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

10 health insurance coverage provided by a health in11 surance issuer, provides any benefits with respect to 

12 ambulance services and emergency services, the plan 

13 or issuer shall cover emergency ambulance services 

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

15 plan or coverage under the same terms and condi16 tions under subparagraphs (A) through (D) of sub17 section (a)(1) under which coverage is provided for 

18 emergency services. 

19 (2) EMERGENCY AMBULANCE SERVICES.—For 

20 purposes of this subsection, the term ‘‘emergency 

21 ambulance services’’ means ambulance services (as 

22 defined for purposes of section 1861(s)(7) of the So23 cial Security Act) furnished to transport an indi24 vidual who has an emergency medical condition (as 

25 defined in subsection (a)(2)(A)) to a hospital for the 
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1 receipt of emergency services (as defined in sub2 section (a)(2)(B)) in a case in which the emergency 

3 services are covered under the plan or coverage pur4 suant to subsection (a)(1) and a prudent layperson, 

5 with an average knowledge of health and medicine, 

6 could reasonably expect that the absence of such 

7 transport would result in placing the health of the 

8 individual in serious jeopardy, serious impairment of 

9 bodily function, or serious dysfunction of any bodily 

10 organ or part. 

11 SEC. 114. TIMELY ACCESS TO SPECIALISTS. 

12 (a) TIMELY ACCESS.—

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

14 health insurance issuer offering health insurance 

15 coverage shall ensure that participants, beneficiaries, 

16 and enrollees receive timely access to specialists who 

17 are appropriate to the condition of, and accessible 

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

19 such specialty care is a covered benefit under the 

20 plan or coverage. 

21 (2) RULE OF CONSTRUCTION.—Nothing in 

22 paragraph (1) shall be construed—

23 (A) to require the coverage under a group 

24 health plan or health insurance coverage of ben25 efits or services; 
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1 (B) to prohibit a plan or issuer from in2 cluding providers in the network only to the ex3 tent necessary to meet the needs of the plan’s 

4 or issuer’s participants, beneficiaries, or enroll5 ees; or 

6 (C) to override any State licensure or 

7 scope-of-practice law. 

8 (3) ACCESS TO CERTAIN PROVIDERS.—

9 (A) IN GENERAL.—With respect to spe10 cialty care under this section, if a participating 

11 specialist is not available and qualified to pro12 vide such care to the participant, beneficiary, or 

13 enrollee, the plan or issuer shall provide for cov14 erage of such care by a nonparticipating spe15 cialist. 

16 (B) TREATMENT OF NONPARTICIPATING

17 PROVIDERS.—If a participant, beneficiary, or 

18 enrollee receives care from a nonparticipating 

19 specialist pursuant to subparagraph (A), such 

20 specialty care shall be provided at no additional 

21 cost to the participant, beneficiary, or enrollee 

22 beyond what the participant, beneficiary, or en23 rollee would otherwise pay for such specialty 

24 care if provided by a participating specialist. 

25 (b) REFERRALS.—
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1 (1) AUTHORIZATION.—Subject to subsection 

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

3 issuer may require an authorization in order to ob4 tain coverage for specialty services under this sec5 tion. Any such authorization—

6 (A) shall be for an appropriate duration of 

7 time or number of referrals, including an au8 thorization for a standing referral where appro9 priate; and 

10 (B) may not be refused solely because the 

11 authorization involves services of a nonpartici12 pating specialist (described in subsection 

13 (a)(3)). 

14 (2) REFERRALS FOR ONGOING SPECIAL CONDI15 TIONS.—

16 (A) IN GENERAL.—Subject to subsection 

17 (a)(1), a group health plan and a health insur18 ance issuer shall permit a participant, bene19 ficiary, or enrollee who has an ongoing special 

20 condition (as defined in subparagraph (B)) to 

21 receive a referral to a specialist for the treat22 ment of such condition and such specialist may 

23 authorize such referrals, procedures, tests, and 

24 other medical services with respect to such con25 dition, or coordinate the care for such condi-
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1 tion, subject to the terms of a treatment plan 

2 (if any) referred to in subsection (c) with re3 spect to the condition. 

4 (B) ONGOING SPECIAL CONDITION DE5 FINED.—In this subsection, the term ‘‘ongoing 

6 special condition’’ means a condition or disease 

7 that—

8 (i) is life-threatening, degenerative, 

9 potentially disabling, or congenital; and 

10 (ii) requires specialized medical care 

11 over a prolonged period of time. 

12 (c) TREATMENT PLANS.—

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

14 health insurance issuer may require that the spe15 cialty care be provided—

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

17 if the treatment plan—

18 (i) is developed by the specialist, in 

19 consultation with the case manager or pri20 mary care provider, and the participant, 

21 beneficiary, or enrollee, and 

22 (ii) is approved by the plan or issuer 

23 in a timely manner, if the plan or issuer 

24 requires such approval; and 
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1 (B) in accordance with applicable quality 

2 assurance and utilization review standards of 

3 the plan or issuer. 

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

5 shall be construed as prohibiting a plan or issuer 

6 from requiring the specialist to provide the plan or 

7 issuer with regular updates on the specialty care 

8 provided, as well as all other reasonably necessary 

9 medical information. 

10 (d) SPECIALIST DEFINED.—For purposes of this sec11 tion, the term ‘‘specialist’’ means, with respect to the con12 dition of the participant, beneficiary, or enrollee, a health 

13 care professional, facility, or center that has adequate ex14 pertise through appropriate training and experience (in15 cluding, in the case of a child, appropriate pediatric exper16 tise) to provide high quality care in treating the condition. 

17 SEC. 115. PATIENT ACCESS TO OBSTETRICAL AND GYNECO18 LOGICAL CARE. 

19 (a) GENERAL RIGHTS.—

20 (1) DIRECT ACCESS.—A group health plan, and 

21 a health insurance issuer offering health insurance 

22 coverage, described in subsection (b) may not re23 quire authorization or referral by the plan, issuer, or 

24 any person (including a primary care provider de25 scribed in subsection (b)(2)) in the case of a female 
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1 participant, beneficiary, or enrollee who seeks cov2 erage for obstetrical or gynecological care provided 

3 by a participating health care professional who spe4 cializes in obstetrics or gynecology. 

5 (2) OBSTETRICAL AND GYNECOLOGICAL

6 CARE.—A group health plan and a health insurance 

7 issuer described in subsection (b) shall treat the pro8 vision of obstetrical and gynecological care, and the 

9 ordering of related obstetrical and gynecological 

10 items and services, pursuant to the direct access de11 scribed under paragraph (1), by a participating 

12 health care professional who specializes in obstetrics 

13 or gynecology as the authorization of the primary 

14 care provider. 

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

16 or health insurance issuer offering health insurance cov17 erage, described in this subsection is a group health plan 

18 or coverage that—

19 (1) provides coverage for obstetric or 

20 gynecologic care; and 

21 (2) requires the designation by a participant, 

22 beneficiary, or enrollee of a participating primary 

23 care provider. 

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

25 be construed to—
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1 (1) waive any exclusions of coverage under the 

2 terms and conditions of the plan or health insurance 

3 coverage with respect to coverage of obstetrical or 

4 gynecological care; or 

5 (2) preclude the group health plan or health in6 surance issuer involved from requiring that the ob7 stetrical or gynecological provider notify the primary 

8 care health care professional or the plan or issuer of 

9 treatment decisions. 

10 SEC. 116. ACCESS TO PEDIATRIC CARE. 

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

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

13 under a group health plan, or health insurance coverage 

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

15 requires or provides for the designation of a participating 

16 primary care provider for the child, the plan or issuer shall 

17 permit such person to designate a physician (allopathic or 

18 osteopathic) who specializes in pediatrics as the child’s pri19 mary care provider if such provider participates in the net20 work of the plan or issuer. 

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

22 be construed to waive any exclusions of coverage under 

23 the terms and conditions of the plan or health insurance 

24 coverage with respect to coverage of pediatric care. 
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1 SEC. 117. CONTINUITY OF CARE. 

2 (a) TERMINATION OF PROVIDER.—

3 (1) IN GENERAL.—If—

4 (A) a contract between a group health 

5 plan, or a health insurance issuer offering 

6 health insurance coverage, and a treating health 

7 care provider is terminated (as defined in para8 graph (e)(4)), or 

9 (B) benefits or coverage provided by a 

10 health care provider are terminated because of 

11 a change in the terms of provider participation 

12 in such plan or coverage, 

13 the plan or issuer shall meet the requirements of 

14 paragraph (3) with respect to each continuing care 

15 patient. 

16 (2) TREATMENT OF TERMINATION OF CON17 TRACT WITH HEALTH INSURANCE ISSUER.—If a 

18 contract for the provision of health insurance cov19 erage between a group health plan and a health in20 surance issuer is terminated and, as a result of such 

21 termination, coverage of services of a health care 

22 provider is terminated with respect to an individual, 

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

24 provisions of this section) shall apply under the plan 

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

26 between the plan and the provider that had been ter-
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1 minated, but only with respect to benefits that are 

2 covered under the plan after the contract termi3 nation. 

4 (3) REQUIREMENTS.—The requirements of this 

5 paragraph are that the plan or issuer—

6 (A) notify the continuing care patient in7 volved, or arrange to have the patient notified 

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

9 of the termination described in paragraph (1) 

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

11 to elect continued transitional care from the 

12 provider under this section; 

13 (B) provide the patient with an oppor14 tunity to notify the plan or issuer of the pa15 tient’s need for transitional care; and 

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

17 patient to elect to continue to be covered with 

18 respect to the course of treatment by such pro19 vider with the provider’s consent during a tran20 sitional period (as provided for under subsection 

21 (b)). 

22 (4) CONTINUING CARE PATIENT.—For purposes 

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

24 means a participant, beneficiary, or enrollee who—
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1 (A) is undergoing a course of treatment 

2 for a serious and complex condition from the 

3 provider at the time the plan or issuer receives 

4 or provides notice of provider, benefit, or cov5 erage termination described in paragraph (1) 

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

7 (B) is undergoing a course of institutional 

8 or inpatient care from the provider at the time 

9 of such notice; 

10 (C) is scheduled to undergo non-elective 

11 surgery from the provider at the time of such 

12 notice; 

13 (D) is pregnant and undergoing a course 

14 of treatment for the pregnancy from the pro15 vider at the time of such notice; or 

16 (E) is or was determined to be terminally 

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

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

19 notice, but only with respect to a provider that 

20 was treating the terminal illness before the date 

21 of such notice. 

22 (b) TRANSITIONAL PERIODS.—

23 (1) SERIOUS AND COMPLEX CONDITIONS.—The 

24 transitional period under this subsection with re25 spect to a continuing care patient described in sub-
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1 section (a)(4)(A) shall extend for up to 90 days (as 

2 determined by the treating health care professional) 

3 from the date of the notice described in subsection 

4 (a)(3)(A). 

5 (2) INSTITUTIONAL OR INPATIENT CARE.—The 

6 transitional period under this subsection for a con7 tinuing care patient described in subsection 

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

9 (A) the expiration of the 90-day period be10 ginning on the date on which the notice under 

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

12 (B) the date of discharge of the patient 

13 from such care or the termination of the period 

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

15 completion of reasonable follow-up care. 

16 (3) SCHEDULED NON-ELECTIVE SURGERY.—

17 The transitional period under this subsection for a 

18 continuing care patient described in subsection 

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

20 surgery involved and post-surgical follow-up care re21 lating to the surgery and occurring within 90 days 

22 after the date of the surgery. 

23 (4) PREGNANCY.—The transitional period 

24 under this subsection for a continuing care patient 

25 described in subsection (a)(4)(D) shall extend 
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1 through the provision of post-partum care directly 

2 related to the delivery. 

3 (5) TERMINAL ILLNESS.—The transitional pe4 riod under this subsection for a continuing care pa5 tient described in subsection (a)(4)(E) shall extend 

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

7 is directly related to the treatment of the terminal 

8 illness or its medical manifestations. 

9 (c) PERMISSIBLE TERMS AND CONDITIONS.—A 

10 group health plan or health insurance issuer may condi11 tion coverage of continued treatment by a provider under 

12 this section upon the provider agreeing to the following 

13 terms and conditions: 

14 (1) The treating health care provider agrees to 

15 accept reimbursement from the plan or issuer and 

16 continuing care patient involved (with respect to 

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

18 start of the transitional period as payment in full 

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

20 rates applicable under the replacement plan or cov21 erage after the date of the termination of the con22 tract with the group health plan or health insurance 

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

24 to the patient in an amount that would exceed the 

25 cost-sharing that could have been imposed if the 
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1 contract referred to in subsection (a)(1) had not 

2 been terminated. 

3 (2) The treating health care provider agrees to 

4 adhere to the quality assurance standards of the 

5 plan or issuer responsible for payment under para6 graph (1) and to provide to such plan or issuer nec7 essary medical information related to the care pro8 vided. 

9 (3) The treating health care provider agrees 

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

11 and procedures, including procedures regarding re12 ferrals and obtaining prior authorization and pro13 viding services pursuant to a treatment plan (if any) 

14 approved by the plan or issuer. 

15 (d) RULES OF CONSTRUCTION.—Nothing in this sec16 tion shall be construed—

17 (1) to require the coverage of benefits which 

18 would not have been covered if the provider involved 

19 remained a participating provider; or 

20 (2) with respect to the termination of a con21 tract under subsection (a) to prevent a group health 

22 plan or health insurance issuer from requiring that 

23 the health care provider—

24 (A) notify participants, beneficiaries, or en25 rollees of their rights under this section; or 
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1 (B) provide the plan or issuer with the 

2 name of each participant, beneficiary, or en3 rollee who the provider believes is a continuing 

4 care patient. 

5 (e) DEFINITIONS.—In this section: 

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

7 with respect to a plan or issuer and a treating 

8 health care provider, a contract between such plan 

9 or issuer and an organized network of providers that 

10 includes the treating health care provider, and (in 

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

12 treating health care provider and the organized net13 work. 

14 (2) HEALTH CARE PROVIDER.—The term 

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

16 (A) any individual who is engaged in the 

17 delivery of health care services in a State and 

18 who is required by State law or regulation to be 

19 licensed or certified by the State to engage in 

20 the delivery of such services in the State; and 

21 (B) any entity that is engaged in the deliv22 ery of health care services in a State and that, 

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

24 licensed or certified by the State to engage in 
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1 the delivery of such services in the State, is so 

2 licensed. 

3 (3) SERIOUS AND COMPLEX CONDITION.—The 

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

5 respect to a participant, beneficiary, or enrollee 

6 under the plan or coverage—

7 (A) in the case of an acute illness, a condi8 tion that is serious enough to require special9 ized medical treatment to avoid the reasonable 

10 possibility of death or permanent harm; or 

11 (B) in the case of a chronic illness or con12 dition, is an ongoing special condition (as de13 fined in section 114(b)(2)(B)). 

14 (4) TERMINATED.—The term ‘‘terminated’’ in15 cludes, with respect to a contract, the expiration or 

16 nonrenewal of the contract, but does not include a 

17 termination of the contract for failure to meet appli18 cable quality standards or for fraud. 

19 SEC. 118. ACCESS TO NEEDED PRESCRIPTION DRUGS. 

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

21 plan, or health insurance coverage offered by a health in22 surance issuer, provides coverage for benefits with respect 

23 to prescription drugs, and limits such coverage to drugs 

24 included in a formulary, the plan or issuer shall—
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1 (1) ensure the participation of physicians and 

2 pharmacists in developing and reviewing such for3 mulary; 

4 (2) provide for disclosure of the formulary to 

5 providers; and 

6 (3) in accordance with the applicable quality as7 surance and utilization review standards of the plan 

8 or issuer, provide for exceptions from the formulary 

9 limitation when a non-formulary alternative is medi10 cally necessary and appropriate and, in the case of 

11 such an exception, apply the same cost-sharing re12 quirements that would have applied in the case of a 

13 drug covered under the formulary. 

14 (b) COVERAGE OF APPROVED DRUGS AND MEDICAL

15 DEVICES.—

16 (1) IN GENERAL.—A group health plan (and 

17 health insurance coverage offered in connection with 

18 such a plan) that provides any coverage of prescrip19 tion drugs or medical devices shall not deny coverage 

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

21 is investigational, if the use—

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

23 (i) is included in the labeling author24 ized by the application in effect for the 

25 drug pursuant to subsection (b) or (j) of 
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1 section 505 of the Federal Food, Drug, 

2 and Cosmetic Act, without regard to any 

3 postmarketing requirements that may 

4 apply under such Act; or 

5 (ii) is included in the labeling author6 ized by the application in effect for the 

7 drug under section 351 of the Public 

8 Health Service Act, without regard to any 

9 postmarketing requirements that may 

10 apply pursuant to such section; or 

11 (B) in the case of a medical device, is in12 cluded in the labeling authorized by a regula13 tion under subsection (d) or (3) of section 513 

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

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

16 an application approved under section 515 of 

17 such Act, without regard to any postmarketing 

18 requirements that may apply under such Act. 

19 (2) CONSTRUCTION.—Nothing in this sub20 section shall be construed as requiring a group 

21 health plan (or health insurance coverage offered in 

22 connection with such a plan) to provide any coverage 

23 of prescription drugs or medical devices. 
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1 SEC. 119. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 

2 APPROVED CLINICAL TRIALS. 

3 (a) COVERAGE.—

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

5 health insurance issuer that is providing health in6 surance coverage, provides coverage to a qualified in7 dividual (as defined in subsection (b)), the plan or 

8 issuer—

9 (A) may not deny the individual participa10 tion in the clinical trial referred to in subsection 

11 (b)(2); 

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

13 (or limit or impose additional conditions on) the 

14 coverage of routine patient costs for items and 

15 services furnished in connection with participa16 tion in the trial; and 

17 (C) may not discriminate against the indi18 vidual on the basis of the enrollee’s participa19 tion in such trial. 

20 (2) EXCLUSION OF CERTAIN COSTS.—For pur21 poses of paragraph (1)(B), routine patient costs do 

22 not include the cost of the tests or measurements 

23 conducted primarily for the purpose of the clinical 

24 trial involved. 

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

26 or more participating providers is participating in a 
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1 clinical trial, nothing in paragraph (1) shall be con2 strued as preventing a plan or issuer from requiring 

3 that a qualified individual participate in the trial 

4 through such a participating provider if the provider 

5 will accept the individual as a participant in the 

6 trial. 

7 (b) QUALIFIED INDIVIDUAL DEFINED.—For pur8 poses of subsection (a), the term ‘‘qualified individual’’ 

9 means an individual who is a participant or beneficiary 

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

11 insurance coverage, and who meets the following condi12 tions: 

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

14 serious illness for which no standard treatment is ef15 fective. 

16 (B) The individual is eligible to participate in 

17 an approved clinical trial according to the trial pro18 tocol with respect to treatment of such illness. 

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

20 offers meaningful potential for significant clinical 

21 benefit for the individual. 

22 (2) Either—

23 (A) the referring physician is a partici24 pating health care professional and has con25 cluded that the individual’s participation in 
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1 such trial would be appropriate based upon the 

2 individual meeting the conditions described in 

3 paragraph (1); or 

4 (B) the participant, beneficiary, or enrollee 

5 provides medical and scientific information es6 tablishing that the individual’s participation in 

7 such trial would be appropriate based upon the 

8 individual meeting the conditions described in 

9 paragraph (1). 

10 (c) PAYMENT.—

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

12 health plan and a health insurance issuer shall pro13 vide for payment for routine patient costs described 

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

15 costs of items and services that are reasonably ex16 pected (as determined by the appropriate Secretary) 

17 to be paid for by the sponsors of an approved clin18 ical trial. 

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

20 items and services provided by—

21 (A) a participating provider, the payment 

22 rate shall be at the agreed upon rate; or 

23 (B) a nonparticipating provider, the pay24 ment rate shall be at the rate the plan or issuer 
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1 would normally pay for comparable services 

2 under subparagraph (A). 

3 (d) APPROVED CLINICAL TRIAL DEFINED.—

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

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

6 study or clinical investigation—

7 (A) approved and funded (which may in8 clude funding through in-kind contributions) by 

9 one or more of the following: 

10 (i) the National Institutes of Health; 

11 (ii) a cooperative group or center of 

12 the National Institutes of Health, includ13 ing a qualified nongovernmental research 

14 entity to which the National Cancer Insti15 tute has awarded a center support grant; 

16 (iii) either of the following if the con17 ditions described in paragraph (2) are 

18 met—

19 (I) the Department of Veterans 

20 Affairs; 

21 (II) the Department of Defense; 

22 or 

23 (B) approved by the Food and Drug Ad24 ministration. 
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1 (2) CONDITIONS FOR DEPARTMENTS.—The 

2 conditions described in this paragraph, for a study 

3 or investigation conducted by a Department, are 

4 that the study or investigation has been reviewed 

5 and approved through a system of peer review that 

6 the appropriate Secretary determines—

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

8 review of studies and investigations used by the 

9 National Institutes of Health; and 

10 (B) assures unbiased review of the highest 

11 ethical standards by qualified individuals who 

12 have no interest in the outcome of the review. 

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

14 construed to limit a plan’s or issuer’s coverage with re15 spect to clinical trials. 

16 SEC. 120. REQUIRED COVERAGE FOR MINIMUM HOSPITAL 

17 STAY FOR MASTECTOMIES AND LYMPH NODE 

18 DISSECTIONS FOR THE TREATMENT OF 

19 BREAST CANCER AND COVERAGE FOR SEC20 ONDARY CONSULTATIONS. 

21 (a) INPATIENT CARE.—

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

23 health insurance issuer providing health insurance 

24 coverage, that provides medical and surgical benefits 

25 shall ensure that inpatient coverage with respect to 
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1 the treatment of breast cancer is provided for a pe2 riod of time as is determined by the attending physi3 cian, in consultation with the patient, to be medi4 cally necessary and appropriate following—

5 (A) a mastectomy; 

6 (B) a lumpectomy; or 

7 (C) a lymph node dissection for the treat8 ment of breast cancer. 

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

10 be construed as requiring the provision of inpatient 

11 coverage if the attending physician and patient de12 termine that a shorter period of hospital stay is 

13 medically appropriate. 

14 (b) PROHIBITION ON CERTAIN MODIFICATIONS.—In 

15 implementing the requirements of this section, a group 

16 health plan, and a health insurance issuer providing health 

17 insurance coverage, may not modify the terms and condi18 tions of coverage based on the determination by a partici19 pant, beneficiary, or enrollee to request less than the min20 imum coverage required under subsection (a). 

21 (c) SECONDARY CONSULTATIONS.—

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

23 health insurance issuer providing health insurance 

24 coverage, that provides coverage with respect to 

25 medical and surgical services provided in relation to 
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1 the diagnosis and treatment of cancer shall ensure 

2 that full coverage is provided for secondary consulta3 tions by specialists in the appropriate medical fields 

4 (including pathology, radiology, and oncology) to 

5 confirm or refute such diagnosis. Such plan or issuer 

6 shall ensure that full coverage is provided for such 

7 secondary consultation whether such consultation is 

8 based on a positive or negative initial diagnosis. In 

9 any case in which the attending physician certifies in 

10 writing that services necessary for such a secondary 

11 consultation are not sufficiently available from spe12 cialists operating under the plan or coverage with re13 spect to whose services coverage is otherwise pro14 vided under such plan or by such issuer, such plan 

15 or issuer shall ensure that coverage is provided with 

16 respect to the services necessary for the secondary 

17 consultation with any other specialist selected by the 

18 attending physician for such purpose at no addi19 tional cost to the individual beyond that which the 

20 individual would have paid if the specialist was par21 ticipating in the network of the plan or issuer. 

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

23 shall be construed as requiring the provision of sec24 ondary consultations where the patient determines 

25 not to seek such a consultation. 
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1 (d) PROHIBITION ON PENALTIES OR INCENTIVES.—

2 A group health plan, and a health insurance issuer pro3 viding health insurance coverage, may not—

4 (1) penalize or otherwise reduce or limit the re5 imbursement of a provider or specialist because the 

6 provider or specialist provided care to a participant, 

7 beneficiary, or enrollee in accordance with this sec8 tion; 

9 (2) provide financial or other incentives to a 

10 physician or specialist to induce the physician or 

11 specialist to keep the length of inpatient stays of pa12 tients following a mastectomy, lumpectomy, or a 

13 lymph node dissection for the treatment of breast 

14 cancer below certain limits or to limit referrals for 

15 secondary consultations; or 

16 (3) provide financial or other incentives to a 

17 physician or specialist to induce the physician or 

18 specialist to refrain from referring a participant, 

19 beneficiary, or enrollee for a secondary consultation 

20 that would otherwise be covered by the plan or cov21 erage involved under subsection (c). 

22 Subtitle C—Access to Information 

23 SEC. 121. PATIENT ACCESS TO INFORMATION. 

24 (a) REQUIREMENT.—

25 (1) DISCLOSURE.—
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1 (A) IN GENERAL.—A group health plan, 

2 and a health insurance issuer that provides cov3 erage in connection with health insurance cov4 erage, shall provide for the disclosure to partici5 pants, beneficiaries, and enrollees—

6 (i) of the information described in 

7 subsection (b) at the time of the initial en8 rollment of the participant, beneficiary, or 

9 enrollee under the plan or coverage; 

10 (ii) of such information on an annual 

11 basis—

12 (I) in conjunction with the elec13 tion period of the plan or coverage if 

14 the plan or coverage has such an elec15 tion period; or 

16 (II) in the case of a plan or cov17 erage that does not have an election 

18 period, in conjunction with the begin19 ning of the plan or coverage year; and 

20 (iii) of information relating to any 

21 material reduction to the benefits or infor22 mation described in such subsection or 

23 subsection (c), in the form of a notice pro24 vided not later than 30 days before the 

25 date on which the reduction takes effect. 
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1 (B) PARTICIPANTS, BENEFICIARIES, AND

2 ENROLLEES.—The disclosure required under 

3 subparagraph (A) shall be provided—

4 (i) jointly to each participant, bene5 ficiary, and enrollee who reside at the same 

6 address; or 

7 (ii) in the case of a beneficiary or en8 rollee who does not reside at the same ad9 dress as the participant or another en10 rollee, separately to the participant or 

11 other enrollees and such beneficiary or en12 rollee. 

13 (2) PROVISION OF INFORMATION.—Information 

14 shall be provided to participants, beneficiaries, and 

15 enrollees under this section at the last known ad16 dress maintained by the plan or issuer with respect 

17 to such participants, beneficiaries, or enrollees, to 

18 the extent that such information is provided to par19 ticipants, beneficiaries, or enrollees via the United 

20 States Postal Service or other private delivery serv21 ice. 

22 (b) REQUIRED INFORMATION.—The informational 

23 materials to be distributed under this section shall include 

24 for each option available under the group health plan or 

25 health insurance coverage the following: 
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1 (1) BENEFITS.—A description of the covered 

2 benefits, including—

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

4 (B) specific preventive services covered 

5 under the plan or coverage if such services are 

6 covered; 

7 (C) any specific exclusions or express limi8 tations of benefits described in section 

9 104(d)(3)(C); 

10 (D) any other benefit limitations, including 

11 any annual or lifetime benefit limits and any 

12 monetary limits or limits on the number of vis13 its, days, or services, and any specific coverage 

14 exclusions; and 

15 (E) any definition of medical necessity 

16 used in making coverage determinations by the 

17 plan, issuer, or claims administrator. 

18 (2) COST SHARING.—A description of any cost19 sharing requirements, including—

20 (A) any premiums, deductibles, coinsur21 ance, copayment amounts, and liability for bal22 ance billing, for which the participant, bene23 ficiary, or enrollee will be responsible under 

24 each option available under the plan; 
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1 (B) any maximum out-of-pocket expense 

2 for which the participant, beneficiary, or en3 rollee may be liable; 

4 (C) any cost-sharing requirements for out5 of-network benefits or services received from 

6 nonparticipating providers; and 

7 (D) any additional cost-sharing or charges 

8 for benefits and services that are furnished 

9 without meeting applicable plan or coverage re10 quirements, such as prior authorization or 

11 precertification. 

12 (3) DISENROLLMENT.—Information relating to 

13 the disenrollment of a participant, beneficiary, or en14 rollee. 

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

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

17 any out-of-area coverage. 

18 (5) PARTICIPATING PROVIDERS.—A directory of 

19 participating providers (to the extent a plan or 

20 issuer provides coverage through a network of pro21 viders) that includes, at a minimum, the name, ad22 dress, and telephone number of each participating 

23 provider, and information about how to inquire 

24 whether a participating provider is currently accept25 ing new patients. 
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1 (6) CHOICE OF PRIMARY CARE PROVIDER.—A 

2 description of any requirements and procedures to 

3 be used by participants, beneficiaries, and enrollees 

4 in selecting, accessing, or changing their primary 

5 care provider, including providers both within and 

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

7 out-of-network services), and the right to select a pe8 diatrician as a primary care provider under section 

9 116 for a participant, beneficiary, or enrollee who is 

10 a child if such section applies. 

11 (7) PREAUTHORIZATION REQUIREMENTS.—A 

12 description of the requirements and procedures to be 

13 used to obtain preauthorization for health services, 

14 if such preauthorization is required. 

15 (8) EXPERIMENTAL AND INVESTIGATIONAL

16 TREATMENTS.—A description of the process for de17 termining whether a particular item, service, or 

18 treatment is considered experimental or investiga19 tional, and the circumstances under which such 

20 treatments are covered by the plan or issuer. 

21 (9) SPECIALTY CARE.—A description of the re22 quirements and procedures to be used by partici23 pants, beneficiaries, and enrollees in accessing spe24 cialty care and obtaining referrals to participating 

25 and nonparticipating specialists, including any limi-
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1 tations on choice of health care professionals re2 ferred to in section 112(b)(2) and the right to timely 

3 access to specialists care under section 114 if such 

4 section applies. 

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

6 circumstances and conditions under which participa7 tion in clinical trials is covered under the terms and 

8 conditions of the plan or coverage, and the right to 

9 obtain coverage for approved clinical trials under 

10 section 119 if such section applies. 

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

12 plan or issuer provides coverage for prescription 

13 drugs, a statement of whether such coverage is lim14 ited to drugs included in a formulary, a description 

15 of any provisions and cost-sharing required for ob16 taining on- and off-formulary medications, and a de17 scription of the rights of participants, beneficiaries, 

18 and enrollees in obtaining access to access to pre19 scription drugs under section 118 if such section ap20 plies. 

21 (12) EMERGENCY SERVICES.—A summary of 

22 the rules and procedures for accessing emergency 

23 services, including the right of a participant, bene24 ficiary, or enrollee to obtain emergency services 

25 under the prudent layperson standard under section 
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1 113, if such section applies, and any educational in2 formation that the plan or issuer may provide re3 garding the appropriate use of emergency services. 

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

5 the plan or issuer’s rules and procedures pertaining 

6 to claims and appeals, a description of the rights 

7 (including deadlines for exercising rights) of partici8 pants, beneficiaries, and enrollees under subtitle A 

9 in obtaining covered benefits, filing a claim for bene10 fits, and appealing coverage decisions internally and 

11 externally (including telephone numbers and mailing 

12 addresses of the appropriate authority), and a de13 scription of any additional legal rights and remedies 

14 available under section 502 of the Employee Retire15 ment Income Security Act of 1974 and applicable 

16 State law. 

17 (14) ADVANCE DIRECTIVES AND ORGAN DONA18 TION.—A description of procedures for advance di19 rectives and organ donation decisions if the plan or 

20 issuer maintains such procedures. 

21 (15) INFORMATION ON PLANS AND ISSUERS.—

22 The name, mailing address, and telephone number 

23 or numbers of the plan administrator and the issuer 

24 to be used by participants, beneficiaries, and enroll25 ees seeking information about plan or coverage bene-
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1 fits and services, payment of a claim, or authoriza2 tion for services and treatment. Notice of whether 

3 the benefits under the plan or coverage are provided 

4 under a contract or policy of insurance issued by an 

5 issuer, or whether benefits are provided directly by 

6 the plan sponsor who bears the insurance risk. 

7 (16) TRANSLATION SERVICES.—A summary de8 scription of any translation or interpretation services 

9 (including the availability of printed information in 

10 languages other than English, audio tapes, or infor11 mation in Braille) that are available for non-English 

12 speakers and participants, beneficiaries, and enroll13 ees with communication disabilities and a description 

14 of how to access these items or services. 

15 (17) ACCREDITATION INFORMATION.—Any in16 formation that is made public by accrediting organi17 zations in the process of accreditation if the plan or 

18 issuer is accredited, or any additional quality indica19 tors (such as the results of enrollee satisfaction sur20 veys) that the plan or issuer makes public or makes 

21 available to participants, beneficiaries, and enrollees. 

22 (18) NOTICE OF REQUIREMENTS.—A descrip23 tion of any rights of participants, beneficiaries, and 

24 enrollees that are established by the Patients’ Bill of 

25 Rights Act of 2004 (excluding those described in 
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1 paragraphs (1) through (17)) if such sections apply. 

2 The description required under this paragraph may 

3 be combined with the notices of the type described 

4 in sections 711(d), 713(b), or 606(a)(1) of the Em5 ployee Retirement Income Security Act of 1974 and 

6 with any other notice provision that the appropriate 

7 Secretary determines may be combined, so long as 

8 such combination does not result in any reduction in 

9 the information that would otherwise be provided to 

10 the recipient. 

11 (19) AVAILABILITY OF ADDITIONAL INFORMA12 TION.—A statement that the information described 

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

14 information (including telephone numbers and, if 

15 available, Internet websites), shall be made available 

16 upon request. 

17 (20) DESIGNATED DECISIONMAKERS.—A de18 scription of the participants and beneficiaries with 

19 respect to whom each designated decisionmaker 

20 under the plan has assumed liability under section 

21 502(o) of the Employee Retirement Income Security 

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

23 decisionmaker. 

24 (c) ADDITIONAL INFORMATION.—The informational 

25 materials to be provided upon the request of a participant, 
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1 beneficiary, or enrollee shall include for each option avail2 able under a group health plan or health insurance cov3 erage the following: 

4 (1) STATUS OF PROVIDERS.—The State licen5 sure status of the plan or issuer’s participating 

6 health care professionals and participating health 

7 care facilities, and, if available, the education, train8 ing, specialty qualifications or certifications of such 

9 professionals. 

10 (2) COMPENSATION METHODS.—A summary 

11 description by category of the applicable methods 

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

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

14 for compensating prospective or treating health care 

15 professionals (including primary care providers and 

16 specialists) and facilities in connection with the pro17 vision of health care under the plan or coverage. 

18 (3) PRESCRIPTION DRUGS.—Information about 

19 whether a specific prescription medication is in20 cluded in the formulary of the plan or issuer, if the 

21 plan or issuer uses a defined formulary. 

22 (4) UTILIZATION REVIEW ACTIVITIES.—A de23 scription of procedures used and requirements (in24 cluding circumstances, timeframes, and appeals 

25 rights) under any utilization review program under 
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1 sections 101 and 102, including any drug formulary 

2 program under section 118. 

3 (5) EXTERNAL APPEALS INFORMATION.—Ag4 gregate information on the number and outcomes of 

5 external medical reviews, relative to the sample size 

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

7 or under the coverage of the issuer. 

8 (d) MANNER OF DISCLOSURE.—The information de9 scribed in this section shall be disclosed in an accessible 

10 medium and format that is calculated to be understood 

11 by a participant or enrollee. 

12 (e) RULES OF CONSTRUCTION.—Nothing in this sec13 tion shall be construed to prohibit a group health plan, 

14 or a health insurance issuer in connection with health in15 surance coverage, from—

16 (1) distributing any other additional informa17 tion determined by the plan or issuer to be impor18 tant or necessary in assisting participants, bene19 ficiaries, and enrollees in the selection of a health 

20 plan or health insurance coverage; and 

21 (2) complying with the provisions of this section 

22 by providing information in brochures, through the 

23 Internet or other electronic media, or through other 

24 similar means, so long as—
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1 (A) the disclosure of such information in 

2 such form is in accordance with requirements 

3 as the appropriate Secretary may impose, and 

4 (B) in connection with any such disclosure 

5 of information through the Internet or other 

6 electronic media—

7 (i) the recipient has affirmatively con8 sented to the disclosure of such informa9 tion in such form, 

10 (ii) the recipient is capable of access11 ing the information so disclosed on the re12 cipient’s individual workstation or at the 

13 recipient’s home, 

14 (iii) the recipient retains an ongoing 

15 right to receive paper disclosure of such in16 formation and receives, in advance of any 

17 attempt at disclosure of such information 

18 to him or her through the Internet or 

19 other electronic media, notice in printed 

20 form of such ongoing right and of the 

21 proper software required to view informa22 tion so disclosed, and 

23 (iv) the plan administrator appro24 priately ensures that the intended recipient 

25 is receiving the information so disclosed 
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1 and provides the information in printed 

2 form if the information is not received. 

3 Subtitle D—Protecting the Doctor4 patient Relationship 

5 SEC. 131. PROHIBITION OF INTERFERENCE WITH CERTAIN 

6 MEDICAL COMMUNICATIONS. 

7 (a) GENERAL RULE.—The provisions of any contract 

8 or agreement, or the operation of any contract or agree9 ment, between a group health plan or health insurance 

10 issuer in relation to health insurance coverage (including 

11 any partnership, association, or other organization that 

12 enters into or administers such a contract or agreement) 

13 and a health care provider (or group of health care pro14 viders) shall not prohibit or otherwise restrict a health 

15 care professional from advising such a participant, bene16 ficiary, or enrollee who is a patient of the professional 

17 about the health status of the individual or medical care 

18 or treatment for the individual’s condition or disease, re19 gardless of whether benefits for such care or treatment 

20 are provided under the plan or coverage, if the professional 

21 is acting within the lawful scope of practice. 

22 (b) NULLIFICATION.—Any contract provision or 

23 agreement that restricts or prohibits medical communica24 tions in violation of subsection (a) shall be null and void. 
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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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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 1852(j)(4) 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 1852(j)(4) of the 

12 Social Security Act to the Secretary, a Medicare+Choice 

13 organization, or an individual enrolled with the organiza14 tion shall be treated as a reference to the applicable au15 thority, a group health plan or health insurance issuer, 

16 respectively, and a participant, beneficiary, or enrollee 

17 with the plan 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 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 
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1 issuer, in a manner that is no less protective than the pro2 visions of section 1842(c)(2) of the Social Security Act 

3 (42 U.S.C. 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 and a 

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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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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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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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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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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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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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 714 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—
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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 
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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. 
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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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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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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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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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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 601, 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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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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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. TREATMENT OF EXCEPTED BENEFITS. 

12 (a) IN GENERAL.—The requirements of this title and 

13 the provisions of sections 502(a)(1)(C), 502(n), and 

14 514(d) of the Employee Retirement Income Security Act 

15 of 1974 (added by section 402) shall not apply to excepted 

16 benefits (as defined in section 733(c) of such Act), other 

17 than benefits described in section 733(c)(2)(A) of such 

18 Act, in the same manner as the provisions of part 7 of 

19 subtitle B of title I of such Act do not apply to such bene20 fits under subsections (b) and (c) of section 732 of such 

21 Act. 

22 (b) COVERAGE OF CERTAIN LIMITED SCOPE

23 PLANS.—Only for purposes of applying the requirements 

24 of this title under sections 2707 and 2753 of the Public 

25 Health Service Act, section 714 of the Employee Retire-
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1 ment Income Security Act of 1974, and section 9813 of 

2 the Internal Revenue Code of 1986, the following sections 

3 shall be deemed not to apply: 

4 (1) Section 2791(c)(2)(A) of the Public Health 

5 Service Act. 

6 (2) Section 733(c)(2)(A) of the Employee Re7 tirement Income Security Act of 1974. 

8 (3) Section 9832(c)(2)(A) of the Internal Rev9 enue Code of 1986. 

10 SEC. 155. REGULATIONS. 

11 The Secretaries of Health and Human Services, 

12 Labor, and the Treasury shall issue such regulations as 

13 may be necessary or appropriate to carry out this title. 

14 Such regulations shall be issued consistent with section 

15 104 of Health Insurance Portability and Accountability 

16 Act of 1996. Such Secretaries may promulgate any in17 terim final rules as the Secretaries determine are appro18 priate to carry out this title. 

19 SEC. 156. INCORPORATION INTO PLAN OR COVERAGE DOC20 UMENTS. 

21 The requirements of this title with respect to a group 

22 health plan or health insurance coverage are, subject to 

23 section 154, deemed to be incorporated into, and made 

24 a part of, such plan or the policy, certificate, or contract 

25 providing such coverage and are enforceable under law as 
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1 if directly included in the documentation of such plan or 

2 such policy, certificate, or contract. 

3 SEC. 157. PRESERVATION OF PROTECTIONS. 

4 (a) IN GENERAL.—The rights under this Act (includ5 ing the right to maintain a civil action and any other 

6 rights under the amendments made by this Act) may not 

7 be waived, deferred, or lost pursuant to any agreement 

8 not authorized under this Act. 

9 (b) EXCEPTION.—Subsection (a) shall not apply to 

10 an agreement providing for arbitration or participation in 

11 any other nonjudicial procedure to resolve a dispute if the 

12 agreement—

13 (1) is entered into knowingly and voluntarily by 

14 the parties involved after the dispute has arisen; or 

15 (2) is pursuant to the terms of a collective bar16 gaining agreement. 

17 Nothing in this subsection shall be construed to permit 

18 the waiver of the requirements of sections 103 and 104 

19 (relating to internal and external review). 
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1 TITLE II—APPLICATION OF 

2 QUALITY CARE STANDARDS 

3 TO GROUP HEALTH PLANS 

4 AND HEALTH INSURANCE 

5 COVERAGE UNDER THE PUB6 LIC HEALTH SERVICE ACT 

7 SEC. 201. APPLICATION TO GROUP HEALTH PLANS AND 

8 GROUP HEALTH INSURANCE COVERAGE. 

9 (a) IN GENERAL.—Subpart 2 of part A of title 

10 XXVII of the Public Health Service Act is amended by 

11 adding at the end the following new section: 

12 ‘‘SEC. 2707. PATIENT PROTECTION STANDARDS. 

13 ‘‘Each group health plan shall comply with patient 

14 protection requirements under title I of the Patients’ Bill 

15 of Rights Act of 2004, and each health insurance issuer 

16 shall comply with patient protection requirements under 

17 such title with respect to group health insurance coverage 

18 it offers, and such requirements shall be deemed to be in19 corporated into this subsection.’’. 

20 (b) CONFORMING AMENDMENT.—Section 

21 2721(b)(2)(A) of such Act (42 U.S.C. 300gg–21(b)(2)(A)) 

22 is amended by inserting ‘‘(other than section 2707)’’ after 

23 ‘‘requirements of such subparts’’. 
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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 Patients’ 

9 Bill of Rights Act of 2004 with respect to individual health 

10 insurance coverage it offers, and such requirements shall 

11 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 Patients’ Bill of Rights Act of 2004 

24 with respect to health insurance coverage offered by a 

25 health insurance issuer and with respect to a group health 

26 plan that is a non-Federal governmental plan. 
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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 INSURANCE PROGRAMS 

11 SEC. 301. APPLICATION OF PATIENT PROTECTION STAND12 ARDS TO FEDERAL HEALTH INSURANCE PRO13 GRAMS. 

14 (a) SENSE OF CONGRESS.—It is the sense of Con15 gress that enrollees in Federal health insurance programs 

16 should have the same rights and privileges as those af17 forded under title I and under the amendments made by 

18 title IV to participants and beneficiaries under group 

19 health plans. 

20 (b) CONFORMING FEDERAL HEALTH INSURANCE

21 PROGRAMS.—It is the sense of Congress that the Presi22 dent should require, by executive order, the Federal offi23 cial with authority over each Federal health insurance pro24 gram, to the extent feasible, to take such steps as are nec-
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1 essary to implement the rights and privileges described in 

2 subsection (a) with respect to such program. 

3 (c) GAO REPORT ON ADDITIONAL STEPS RE4 QUIRED.—Not later than 1 year after the date of the en5 actment of this Act, the Comptroller General of the United 

6 States shall submit to Congress a report on statutory 

7 changes that are required to implement such rights and 

8 privileges in a manner that is consistent with the missions 

9 of the Federal health insurance programs and that avoids 

10 unnecessary duplication or disruption of such programs. 

11 (d) FEDERAL HEALTH INSURANCE PROGRAM.—In 

12 this section, the term ‘‘Federal health insurance program’’ 

13 means a Federal program that provides creditable cov14 erage (as defined in section 2701(c)(1) of the Public 

15 Health Service Act) and includes a health program of the 

16 Department of Veterans Affairs. 
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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 Patients’ Bill of Rights Act of 2004 (as in effect as 

18 of the date of the enactment of such Act), and such re19 quirements shall be deemed to be incorporated into this 

20 subsection. 

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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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 Patients’ Bill of Rights Act 

5 of 2004 with respect to such benefits and not be 

6 considered as failing to meet such requirements be7 cause of a failure of the issuer to meet such require8 ments so long as the plan sponsor or its representa9 tives did 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 Patients’ Bill of Rights Act of 

16 2004, in the case of a group health plan that pro17 vides benefits in the form of health insurance cov18 erage through a health insurance issuer, the Sec19 retary shall determine the circumstances under 

20 which the plan is not required to provide or make 

21 available the information (and is not liable for the 

22 issuer’s failure to provide or make available the in23 formation), if the issuer is obligated to provide and 

24 make available (or provides and makes available) 

25 such information. 
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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 Pa25 tients’ Bill of Rights Act of 2004, the group health 
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1 plan shall not be liable for such violation unless the 

2 plan 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 in connection with health insurance cov20 erage, any reference in this subsection to a require21 ment in a section or other provision in the Patients’ 

22 Bill of Rights Act of 2004 with respect to a health 

23 insurance issuer is deemed to include a reference to 

24 a requirement under a State law that substantially 

25 complies (as determined under section 152(c) of 
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1 such Act) with the requirement in such section or 

2 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 

6 Patients’ Bill of Rights Act of 2004, for purposes of 

7 this subtitle the term ‘group health plan’ is deemed 

8 to include a reference to an institutional health care 

9 provider. 

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 Patients’ Bill of Rights 

15 Act of 2004 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. 
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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 Patients’ Bill of 

10 Rights Act of 2004 with the reporting and disclosure re11 quirements imposed under part 1, so long as such coordi12 nation does not result in any reduction in the information 

13 that 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.’’ and 

18 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 Patients’ Bill of Rights Act of 2004, 

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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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:

‘‘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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1 for benefits of a participant or beneficiary 

2 under section 102 of the Patients’ Bill of 

3 Rights Act of 2004 (relating to procedures for 

4 initial claims for benefits and prior authoriza5 tion determinations) or upon review of a denial 

6 of such a claim under section 103 of such Act 

7 (relating to internal appeal of a denial of a 

8 claim for benefits), fails to exercise ordinary 

9 care in making 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 
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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 Patients’ Bill of Rights Act of 2004 (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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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 AND RELATED RULES.—For 

7 purposes of this subsection.—

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 Patients’ Bill of 

23 Rights Act of 2004. 

24 ‘‘(D) TERMS AND CONDITIONS.—The term 

25 ‘terms and conditions’ includes, with respect to 
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1 a group health plan or health insurance cov2 erage, requirements imposed under title I of the 

3 Patients’ Bill of Rights Act of 2004. 

4 ‘‘(E) TREATMENT OF EXCEPTED BENE5 FITS.—Under section 154(a) of the Patients’ 

6 Bill of Rights Act of 2004, the provisions of 

7 this subsection and subsection (a)(1)(C) do not 

8 apply to certain excepted benefits. 

9 ‘‘(5) EXCLUSION OF EMPLOYERS AND OTHER

10 PLAN SPONSORS.—

11 ‘‘(A) CAUSES OF ACTION AGAINST EM12 PLOYERS AND PLAN SPONSORS PRECLUDED.—

13 Subject to subparagraph (B), paragraph (1)(A) 

14 does not authorize a cause of action against an 

15 employer or other plan sponsor maintaining the 

16 plan (or against an employee of such an em17 ployer or sponsor acting within the scope of em18 ployment). 

19 ‘‘(B) CERTAIN CAUSES OF ACTION PER20 MITTED.—Notwithstanding subparagraph (A), 

21 a cause of action may arise against an employer 

22 or other plan sponsor (or against an employee 

23 of such an employer or sponsor acting within 

24 the scope of employment) under paragraph 

25 (1)(A), to the extent there was direct participa-
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1 tion by the employer or other plan sponsor (or 

2 employee) in the decision of the plan under sec3 tion 102 of the Patients’ Bill of Rights Act of 

4 2004 upon consideration of a claim for benefits 

5 or under section 103 of such Act upon review 

6 of a denial of a claim for benefits. 

7 ‘‘(C) DIRECT PARTICIPATION.—

8 ‘‘(i) IN GENERAL.—For purposes of 

9 subparagraph (B), the term ‘direct partici10 pation’ means, in connection with a deci11 sion described in paragraph (1)(A), the ac12 tual making of such decision or the actual 

13 exercise of control in making such decision. 

14 ‘‘(ii) RULES OF CONSTRUCTION.—For 

15 purposes of clause (i), the employer or plan 

16 sponsor (or employee) shall not be con17 strued to be engaged in direct participation 

18 because of any form of decisionmaking or 

19 other conduct that is merely collateral or 

20 precedent to the decision described in 

21 paragraph (1)(A) on a particular claim for 

22 benefits of a participant or beneficiary, in23 cluding (but not limited to)—

24 ‘‘(I) any participation by the em25 ployer or other plan sponsor (or em-
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1 ployee) in the selection of the group 

2 health plan or health insurance cov3 erage involved or the third party ad4 ministrator or other agent; 

5 ‘‘(II) any engagement by the em6 ployer or other plan sponsor (or em7 ployee) in any cost-benefit analysis 

8 undertaken in connection with the se9 lection of, or continued maintenance 

10 of, the plan or coverage involved; 

11 ‘‘(III) any participation by the 

12 employer or other plan sponsor (or 

13 employee) in the process of creating, 

14 continuing, modifying, or terminating 

15 the plan or any benefit under the 

16 plan, if such process was not substan17 tially focused solely on the particular 

18 situation of the participant or bene19 ficiary referred to in paragraph 

20 (1)(A); and 

21 ‘‘(IV) any participation by the 

22 employer or other plan sponsor (or 

23 employee) in the design of any benefit 

24 under the plan, including the amount 
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1 of copayment and limits connected 

2 with such benefit. 

3 ‘‘(iii) IRRELEVANCE OF CERTAIN COL4 LATERAL EFFORTS MADE BY EMPLOYER

5 OR PLAN SPONSOR.—For purposes of this 

6 subparagraph, an employer or plan sponsor 

7 shall not be treated as engaged in direct 

8 participation in a decision with respect to 

9 any claim for benefits or denial thereof in 

10 the case of any particular participant or 

11 beneficiary solely by reason of—

12 ‘‘(I) any efforts that may have 

13 been made by the employer or plan 

14 sponsor to advocate for authorization 

15 of coverage for that or any other par16 ticipant or beneficiary (or any group 

17 of participants or beneficiaries), or 

18 ‘‘(II) any provision that may 

19 have been made by the employer or 

20 plan sponsor for benefits which are 

21 not covered under the terms and con22 ditions of the plan for that or any 

23 other participant or beneficiary (or 

24 any group of participants or bene25 ficiaries). 
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1 ‘‘(D) APPLICATION TO CERTAIN PLANS.—

2 ‘‘(i) IN GENERAL.—Notwithstanding 

3 any other provision of this subsection, no 

4 group health plan described in clause (ii) 

5 (or plan sponsor of such a plan) shall be 

6 liable under paragraph (1) for the perform7 ance of, or the failure to perform, any non8 medically reviewable duty under the plan. 

9 ‘‘(ii) DEFINITION.—A group health 

10 plan described in this clause is—

11 ‘‘(I) a group health plan that is 

12 self-insured and self administered by 

13 an employer (including an employee of 

14 such an employer acting within the 

15 scope of employment); or 

16 ‘‘(II) a multiemployer plan as de17 fined in section 3(37)(A) (including 

18 an employee of a contributing em19 ployer or of the plan, or a fiduciary of 

20 the plan, acting within the scope of 

21 employment or fiduciary responsi22 bility) that is self-insured and self-ad23 ministered. 

24 ‘‘(6) EXCLUSION OF PHYSICIANS AND OTHER

25 HEALTH CARE PROFESSIONALS.—
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1 ‘‘(A) IN GENERAL.—No treating physician 

2 or other treating health care professional of the 

3 participant or beneficiary, and no person acting 

4 under the direction of such a physician or 

5 health care professional, shall be liable under 

6 paragraph (1) for the performance of, or the 

7 failure to perform, any non-medically reviewable 

8 duty of the plan, the plan sponsor, or any 

9 health insurance issuer offering health insur10 ance coverage in connection with the plan. 

11 ‘‘(B) DEFINITIONS.—For purposes of sub12 paragraph (A)—

13 ‘‘(i) HEALTH CARE PROFESSIONAL.—

14 The term ‘health care professional’ means 

15 an individual who is licensed, accredited, or 

16 certified under State law to provide speci17 fied health care services and who is oper18 ating within the scope of such licensure, 

19 accreditation, or certification. 

20 ‘‘(ii) NON-MEDICALLY REVIEWABLE

21 DUTY.—The term ‘non-medically review22 able duty’ means a duty the discharge of 

23 which does not include the making of a 

24 medically reviewable decision. 
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1 ‘‘(7) EXCLUSION OF HOSPITALS.—No treating 

2 hospital of the participant or beneficiary shall be lia3 ble under paragraph (1) for the performance of, or 

4 the failure to perform, any non-medically reviewable 

5 duty (as defined in paragraph (6)(B)(ii)) of the 

6 plan, the plan sponsor, or any health insurance 

7 issuer offering health insurance coverage in connec8 tion with the plan. 

9 ‘‘(8) RULE OF CONSTRUCTION RELATING TO

10 EXCLUSION FROM LIABILITY OF PHYSICIANS, 

11 HEALTH CARE PROFESSIONALS, AND HOSPITALS.—

12 Nothing in paragraph (6) or (7) shall be construed 

13 to limit the liability (whether direct or vicarious) of 

14 the plan, the plan sponsor, or any health insurance 

15 issuer offering health insurance coverage in connec16 tion with the plan. 

17 ‘‘(9) REQUIREMENT OF EXHAUSTION.—

18 ‘‘(A) IN GENERAL.—A cause of action may 

19 not be brought under paragraph (1) in connec20 tion with any denial of a claim for benefits of 

21 any individual until all administrative processes 

22 under sections 102 and 103 of the Patients’ 

23 Bill of Rights Act of 2004 (if applicable) have 

24 been exhausted. 
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1 ‘‘(B) EXCEPTION FOR NEEDED CARE.—A 

2 participant or beneficiary may seek relief exclu3 sively in Federal court under subsection 

4 502(a)(1)(B) prior to the exhaustion of admin5 istrative remedies under sections 102, 103, or 

6 104 of the Patients’ Bill of Rights Act of 2004 

7 (as required under subparagraph (A)) if it is 

8 demonstrated to the court that the exhaustion 

9 of such remedies would cause irreparable harm 

10 to the health of the participant or beneficiary. 

11 Notwithstanding the awarding of relief under 

12 subsection 502(a)(1)(B) pursuant to this sub13 paragraph, no relief shall be available as a re14 sult of, or arising under, paragraph (1)(A) or 

15 paragraph (10)(B), with respect to a partici16 pant or beneficiary, unless the requirements of 

17 subparagraph (A) are met. 

18 ‘‘(C) RECEIPT OF BENEFITS DURING AP19 PEALS PROCESS.—Receipt by the participant or 

20 beneficiary of the benefits involved in the claim 

21 for benefits during the pendency of any admin22 istrative processes referred to in subparagraph 

23 (A) or of any action commenced under this sub24 section—
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1 ‘‘(i) shall not preclude continuation of 

2 all such administrative processes to their 

3 conclusion if so moved by any party, and 

4 ‘‘(ii) shall not preclude any liability 

5 under subsection (a)(1)(C) and this sub6 section in connection with such claim. 

7 The court in any action commenced under this 

8 subsection shall take into account any receipt of 

9 benefits during such administrative processes or 

10 such action in determining the amount of the 

11 damages awarded. 

12 ‘‘(D) ADMISSIBLE.—Any determination 

13 made by a reviewer in an administrative pro14 ceeding under section 103 of the Patients’ Bill 

15 of Rights Act of 2004 shall be admissible in 

16 any Federal court proceeding and shall be pre17 sented to the trier of fact. 

18 ‘‘(10) STATUTORY DAMAGES.—

19 ‘‘(A) IN GENERAL.—The remedies set 

20 forth in this subsection (n) shall be the exclu21 sive remedies for causes of action brought 

22 under this subsection. 

23 ‘‘(B) ASSESSMENT OF CIVIL PENALTIES.—

24 In addition to the remedies provided for in 

25 paragraph (1) (relating to the failure to provide 
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1 contract benefits in accordance with the plan), 

2 a civil assessment, in an amount not to exceed 

3 $5,000,000, payable to the claimant may be 

4 awarded in any action under such paragraph if 

5 the claimant establishes by clear and convincing 

6 evidence that the alleged conduct carried out by 

7 the defendant demonstrated bad faith and fla8 grant disregard for the rights of the participant 

9 or beneficiary under the plan and was a proxi10 mate cause of the personal injury or death that 

11 is the subject of the claim. 

12 ‘‘(11) LIMITATION ON ATTORNEYS’ FEES.—

13 ‘‘(A) IN GENERAL.—Notwithstanding any 

14 other provision of law, or any arrangement, 

15 agreement, or contract regarding an attorney’s 

16 fee, the amount of an attorney’s contingency fee 

17 allowable for a cause of action brought pursuant to this subsection shall not exceed 1 18 ⁄3 of the 

19 total amount of the plaintiff’s recovery (not in20 cluding the reimbursement of actual out-of21 pocket expenses of the attorney). 

22 ‘‘(B) DETERMINATION BY DISTRICT

23 COURT.—The last Federal district court in 

24 which the action was pending upon the final 

25 disposition, including all appeals, of the action 
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1 shall have jurisdiction to review the attorney’s 

2 fee to ensure that the fee is a reasonable one. 

3 ‘‘(12) LIMITATION OF ACTION.—Paragraph (1) 

4 shall not apply in connection with any action com5 menced after 3 years after the later of—

6 ‘‘(A) the date on which the plaintiff first 

7 knew, or reasonably should have known, of the 

8 personal injury or death resulting from the fail9 ure described in paragraph (1), or 

10 ‘‘(B) the date as of which the requirements 

11 of paragraph (9) are first met. 

12 ‘‘(13) TOLLING PROVISION.—The statute of 

13 limitations for any cause of action arising under 

14 State law relating to a denial of a claim for benefits 

15 that is the subject of an action brought in Federal 

16 court under this subsection shall be tolled until such 

17 time as the Federal court makes a final disposition, 

18 including all appeals, of whether such claim should 

19 properly be within the jurisdiction of the Federal 

20 court. The tolling period shall be determined by the 

21 applicable Federal or State law, whichever period is 

22 greater. 

23 ‘‘(14) PURCHASE OF INSURANCE TO COVER LI24 ABILITY.—Nothing in section 410 shall be construed 

25 to preclude the purchase by a group health plan of 
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1 insurance to cover any liability or losses arising 

2 under a cause of action under subsection (a)(1)(C) 

3 and this subsection. 

4 ‘‘(15) EXCLUSION OF DIRECTED RECORD5 KEEPERS.—

6 ‘‘(A) IN GENERAL.—Subject to subpara7 graph (C), paragraph (1) shall not apply with 

8 respect to a directed recordkeeper in connection 

9 with a group health plan. 

10 ‘‘(B) DIRECTED RECORDKEEPER.—For 

11 purposes of this paragraph, the term ‘directed 

12 recordkeeper’ means, in connection with a 

13 group health plan, a person engaged in directed 

14 recordkeeping activities pursuant to the specific 

15 instructions of the plan or the employer or 

16 other plan sponsor, including the distribution of 

17 enrollment information and distribution of dis18 closure materials under this Act or title I of the 

19 Patients’ Bill of Rights Act of 2004 and whose 

20 duties do not include making decisions on 

21 claims for benefits. 

22 ‘‘(C) LIMITATION.—Subparagraph (A) 

23 does not apply in connection with any directed 

24 recordkeeper to the extent that the directed rec25 ordkeeper fails to follow the specific instruction 
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1 of the plan or the employer or other plan spon2 sor. 

3 ‘‘(16) EXCLUSION OF HEALTH INSURANCE

4 AGENTS.—Paragraph (1) does not apply with re5 spect to a person whose sole involvement with the 

6 group health plan is providing advice or administra7 tive services to the employer or other plan sponsor 

8 relating to the selection of health insurance coverage 

9 offered in connection with the plan. 

10 ‘‘(17) NO EFFECT ON STATE LAW.—No provi11 sion of State law (as defined in section 514(c)(1)) 

12 shall be treated as superseded or otherwise altered, 

13 amended, modified, invalidated, or impaired by rea14 son of the provisions of subsection (a)(1)(C) and this 

15 subsection. 

16 ‘‘(18) RELIEF FROM LIABILITY FOR EMPLOYER

17 OR OTHER PLAN SPONSOR BY MEANS OF DES18 IGNATED DECISIONMAKER.—

19 ‘‘(A) IN GENERAL.—Notwithstanding the 

20 direct participation (as defined in paragraph 

21 (5)(C)(i)) of an employer or plan sponsor, in 

22 any case in which there is (or is deemed under 

23 subparagraph (B) to be) a designated decision24 maker under subparagraph (B) that meets the 
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1 requirements of subsection (o)(1) for an em2 ployer or other plan sponsor—

3 ‘‘(i) all liability of such employer or 

4 plan sponsor involved (and any employee of 

5 such employer or sponsor acting within the 

6 scope of employment) under this sub7 section in connection with any participant 

8 or beneficiary shall be transferred to, and 

9 assumed by, the designated decisionmaker, 

10 and 

11 ‘‘(ii) with respect to such liability, the 

12 designated decisionmaker shall be sub13 stituted for the employer or sponsor (or 

14 employee) in the action and may not raise 

15 any defense that the employer or sponsor 

16 (or employee) could not raise if such a de17 cisionmaker were not so deemed. 

18 ‘‘(B) AUTOMATIC DESIGNATION.—A health 

19 insurance issuer shall be deemed to be a des20 ignated decisionmaker for purposes of subpara21 graph (A) with respect to the participants and 

22 beneficiaries of an employer or plan sponsor, 

23 whether or not the employer or plan sponsor 

24 makes such a designation, and shall be deemed 

25 to have assumed unconditionally all liability of 
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1 the employer or plan sponsor under such des2 ignation in accordance with subsection (o), un3 less the employer or plan sponsor affirmatively 

4 enters into a contract to prevent the service of 

5 the designated decisionmaker. 

6 ‘‘(C) TREATMENT OF CERTAIN TRUST

7 FUNDS.—For purposes of this paragraph, the 

8 terms ‘employer’ and ‘plan sponsor’, in connec9 tion with the assumption by a designated deci10 sionmaker of the liability of employer or other 

11 plan sponsor pursuant to this paragraph, shall 

12 be construed to include a trust fund maintained 

13 pursuant to section 302 of the Labor Manage14 ment Relations Act, 1947 (29 U.S.C. 186) or 

15 the Railway Labor Act (45 U.S.C. 151 et seq.). 

16 ‘‘(19) PREVIOUSLY PROVIDED SERVICES.—

17 ‘‘(A) IN GENERAL.—Except as provided in 

18 this paragraph, a cause of action shall not arise 

19 under paragraph (1) where the denial involved 

20 relates to an item or service that has already 

21 been fully provided to the participant or bene22 ficiary under the plan or coverage and the claim 

23 relates solely to the subsequent denial of pay24 ment for the provision of such item or service. 
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1 ‘‘(B) EXCEPTION.—Nothing in subpara2 graph (A) shall be construed to—

3 ‘‘(i) prohibit a cause of action under 

4 paragraph (1) where the nonpayment in5 volved results in the participant or bene6 ficiary being unable to receive further 

7 items or services that are directly related 

8 to the item or service involved in the denial 

9 referred to in subparagraph (A) or that 

10 are part of a continuing treatment or se11 ries of procedures; or 

12 ‘‘(ii) limit liability that otherwise 

13 would arise from the provision of the item 

14 or services or the performance of a medical 

15 procedure. 

16 ‘‘(20) EXEMPTION FROM PERSONAL LIABILITY

17 FOR INDIVIDUAL MEMBERS OF BOARDS OF DIREC18 TORS, JOINT BOARDS OF TRUSTEES, ETC.—Any indi19 vidual who is—

20 ‘‘(A) a member of a board of directors of 

21 an employer or plan sponsor; or 

22 ‘‘(B) a member of an association, com23 mittee, employee organization, joint board of 

24 trustees, or other similar group of representa25 tives of the entities that are the plan sponsor 
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1 of plan maintained by two or more employers 

2 and one or more employee organizations; 

3 shall not be personally liable under this subsection 

4 for conduct that is within the scope of employment 

5 or of plan-related duties of the individuals unless the 

6 individual acts in a fraudulent manner for personal 

7 enrichment. 

8 ‘‘(o) REQUIREMENTS FOR DESIGNATED DECISION9 MAKERS OF GROUP HEALTH PLANS.—

10 ‘‘(1) IN GENERAL.—For purposes of subsection 

11 (n)(18) and section 514(d)(9), a designated decision12 maker meets the requirements of this paragraph 

13 with respect to any participant or beneficiary if—

14 ‘‘(A) such designation is in such form as 

15 may be prescribed in regulations of the Sec16 retary, 

17 ‘‘(B) the designated decisionmaker—

18 ‘‘(i) meets the requirements of para19 graph (2), 

20 ‘‘(ii) assumes unconditionally all liabil21 ity of the employer or plan sponsor in22 volved (and any employee of such employer 

23 or sponsor acting within the scope of em24 ployment) either arising under subsection 

25 (n) or arising in a cause of action per-
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1 mitted under section 514(d) in connection 

2 with actions (and failures to act) of the 

3 employer or plan sponsor (or employee) oc4 curring during the period in which the des5 ignation under subsection (n)(18) or sec6 tion 514(d)(9) is in effect relating to such 

7 participant and beneficiary, 

8 ‘‘(iii) agrees to be substituted for the 

9 employer or plan sponsor (or employee) in 

10 the action and not to raise any defense 

11 with respect to such liability that the em12 ployer or plan sponsor (or employee) may 

13 not raise, and 

14 ‘‘(iv) where paragraph (2)(B) applies, 

15 assumes unconditionally the exclusive au16 thority under the group health plan to 

17 make medically reviewable decisions under 

18 the plan with respect to such participant 

19 or beneficiary, and 

20 ‘‘(C) the designated decisionmaker and the 

21 participants and beneficiaries for whom the de22 cisionmaker has assumed liability are identified 

23 in the written instrument required under sec24 tion 402(a) and as required under section 
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1 121(b)(19) of the Patients’ Bill of Rights Act 

2 of 2004. 

3 Any liability assumed by a designated decisionmaker 

4 pursuant to this subsection shall be in addition to 

5 any liability that it may otherwise have under appli6 cable law. 

7 ‘‘(2) QUALIFICATIONS FOR DESIGNATED DECI8 SIONMAKERS.—

9 ‘‘(A) IN GENERAL.—Subject to subpara10 graph (B), an entity is qualified under this 

11 paragraph to serve as a designated decision12 maker with respect to a group health plan if the 

13 entity has the ability to assume the liability de14 scribed in paragraph (1) with respect to partici15 pants and beneficiaries under such plan, includ16 ing requirements relating to the financial obli17 gation for timely satisfying the assumed liabil18 ity, and maintains with the plan sponsor and 

19 the Secretary certification of such ability. Such 

20 certification shall be provided to the plan spon21 sor or named fiduciary and to the Secretary 

22 upon designation under subsection (n)(18)(B) 

23 or section 517(d)(9)(B) and not less frequently 

24 than annually thereafter, or if such designation 
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1 constitutes a multiyear arrangement, in con2 junction with the renewal of the arrangement. 

3 ‘‘(B) SPECIAL QUALIFICATION IN THE

4 CASE OF CERTAIN REVIEWABLE DECISIONS.—In 

5 the case of a group health plan that provides 

6 benefits consisting of medical care to a partici7 pant or beneficiary only through health insur8 ance coverage offered by a single health insur9 ance issue, such issuer is the only entity that 

10 may be qualified under this paragraph to serve 

11 as a designated decisionmaker with respect to 

12 such participant or beneficiary, and shall serve 

13 as the designated decisionmaker unless the em14 ployer or other plan sponsor acts affirmatively 

15 to prevent such service. 

16 ‘‘(3) REQUIREMENTS RELATING TO FINANCIAL

17 OBLIGATIONS.—For purposes of paragraph (2)(A), 

18 the requirements relating to the financial obligation 

19 of an entity for liability shall include—

20 ‘‘(A) coverage of such entity under an in21 surance policy or other arrangement, secured 

22 and maintained by such entity, to effectively in23 sure such entity against losses arising from pro24 fessional liability claims, including those arising 
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1 from its service as a designated decisionmaker 

2 under this part; or 

3 ‘‘(B) evidence of minimum capital and sur4 plus levels that are maintained by such entity 

5 to cover any losses as a result of liability arising 

6 from its service as a designated decisionmaker 

7 under this part. 

8 The appropriate amounts of liability insurance and 

9 minimum capital and surplus levels for purposes of 

10 subparagraphs (A) and (B) shall be determined by 

11 an actuary using sound actuarial principles and ac12 counting practices pursuant to established guidelines 

13 of the American Academy of Actuaries and in ac14 cordance with such regulations as the Secretary may 

15 prescribe and shall be maintained throughout the 

16 term for which the designation is in effect. The pro17 visions of this paragraph shall not apply in the case 

18 of a designated decisionmaker that is a group health 

19 plan, plan sponsor, or health insurance issuer and 

20 that is regulated under Federal law or a State finan21 cial solvency law. 

22 ‘‘(4) LIMITATION ON APPOINTMENT OF TREAT23 ING PHYSICIANS.—A treating physician who directly 

24 delivered the care, treatment, or provided the patient 

25 service that is the subject of a cause of action by a 
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1 participant or beneficiary under subsection (n) or 

2 section 514(d) may not be designated as a des3 ignated decisionmaker under this subsection with re4 spect to such participant or beneficiary.’’. 

5 (2) CONFORMING AMENDMENT.—Section 

6 502(a)(1) of such Act (29 U.S.C. 1132(a)(1)) is 

7 amended—

8 (A) by striking ‘‘or’’ at the end of subpara9 graph (A); 

10 (B) in subparagraph (B), by striking 

11 ‘‘plan;’’ and inserting ‘‘plan, or’’; and 

12 (C) by adding at the end the following new 

13 subparagraph: 

14 ‘‘(C) for the relief provided for in sub15 section (n) of this section.’’. 

16 (b) RULES RELATING TO ERISA PREEMPTION.—

17 Section 514 of the Employee Retirement Income Security 

18 Act of 1974 (29 U.S.C. 1144) is amended—

19 (1) by redesignating subsection (d) as sub20 section (f); and 

21 (2) by inserting after subsection (c) the fol22 lowing new subsections: 

23 ‘‘(d) PREEMPTION NOT TO APPLY TO CAUSES OF AC24 TION UNDER STATE LAW INVOLVING MEDICALLY RE25 VIEWABLE DECISION.—
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1 ‘‘(1) NON-PREEMPTION OF CERTAIN CAUSES OF

2 ACTION.—

3 ‘‘(A) IN GENERAL.—Except as provided in 

4 this subsection, nothing in this title (including 

5 section 502) shall be construed to supersede or 

6 otherwise alter, amend, modify, invalidate, or 

7 impair any cause of action under State law of 

8 a participant or beneficiary under a group 

9 health plan (or the estate of such a participant 

10 or beneficiary) against the plan, the plan spon11 sor, any health insurance issuer offering health 

12 insurance coverage in connection with the plan, 

13 or any managed care entity in connection with 

14 the plan to recover damages resulting from per15 sonal injury or for wrongful death if such cause 

16 of action arises by reason of a medically review17 able decision. 

18 ‘‘(B) MEDICALLY REVIEWABLE DECI19 SION.—For purposes of subparagraph (A), the 

20 term ‘medically reviewable decision’ means a de21 nial of a claim for benefits under the plan 

22 which is described in section 104(d)(2) of the 

23 Patients’ Bill of Rights Act of 2004 (relating to 

24 medically reviewable decisions). 
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1 ‘‘(C) LIMITATION ON PUNITIVE DAM2 AGES.—

3 ‘‘(i) IN GENERAL.—Except as pro4 vided in clauses (ii) and (iii), with respect 

5 to a cause of action described in subpara6 graph (A) brought with respect to a partic7 ipant or beneficiary, State law is super8 seded insofar as it provides any punitive, 

9 exemplary, or similar damages if, as of the 

10 time of the personal injury or death, all 

11 the requirements of the following sections 

12 of the Patients’ Bill of Rights Act of 2004 

13 were satisfied with respect to the partici14 pant or beneficiary: 

15 ‘‘(I) Section 102 (relating to pro16 cedures for initial claims for benefits 

17 and prior authorization determina18 tions). 

19 ‘‘(II) Section 103 of such Act 

20 (relating to internal appeals of claims 

21 denials). 

22 ‘‘(III) Section 104 of such Act 

23 (relating to independent external ap24 peals procedures). 
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1 ‘‘(ii) EXCEPTION FOR CERTAIN AC2 TIONS FOR WRONGFUL DEATH.—Clause (i) 

3 shall not apply with respect to an action 

4 for wrongful death if the applicable State 

5 law provides (or has been construed to pro6 vide) for damages in such an action which 

7 are only punitive or exemplary in nature. 

8 ‘‘(iii) EXCEPTION FOR WILLFUL OR

9 WANTON DISREGARD FOR THE RIGHTS OR

10 SAFETY OF OTHERS.—Clause (i) shall not 

11 apply with respect to any cause of action 

12 described in subparagraph (A) if, in such 

13 action, the plaintiff establishes by clear 

14 and convincing evidence that conduct car15 ried out by the defendant with willful or 

16 wanton disregard for the rights or safety 

17 of others was a proximate cause of the per18 sonal injury or wrongful death that is the 

19 subject of the action. 

20 ‘‘(2) DEFINITIONS AND RELATED RULES.—For 

21 purposes of this subsection and subsection (e)—

22 ‘‘(A) TREATMENT OF EXCEPTED BENE23 FITS.—Under section 154(a) of the Patients’ 

24 Bill of Rights Act of 2004, the provisions of 
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1 this subsection do not apply to certain excepted 

2 benefits. 

3 ‘‘(B) PERSONAL INJURY.—The term ‘per4 sonal injury’ means a physical injury and in5 cludes an injury arising out of the treatment 

6 (or failure to treat) a mental illness or disease. 

7 ‘‘(C) CLAIM FOR BENEFIT; DENIAL.—The 

8 terms ‘claim for benefits’ and ‘denial of a claim 

9 for benefits’ shall have the meaning provided 

10 such terms under section 102(e) of the Pa11 tients’ Bill of Rights Act of 2004. 

12 ‘‘(D) MANAGED CARE ENTITY.—

13 ‘‘(i) IN GENERAL.—The term ‘man14 aged care entity’ means, in connection with 

15 a group health plan and subject to clause 

16 (ii), any entity that is involved in deter17 mining the manner in which or the extent 

18 to which items or services (or reimburse19 ment therefor) are to be provided as bene20 fits under the plan. 

21 ‘‘(ii) TREATMENT OF TREATING PHY22 SICIANS, OTHER TREATING HEALTH CARE

23 PROFESSIONALS, AND TREATING HOS24 PITALS.—Such term does not include a 

25 treating physician or other treating health 
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1 care professional (as defined in section 

2 502(n)(6)(B)(i)) of the participant or ben3 eficiary and also does not include a treat4 ing hospital insofar as it is acting solely in 

5 the capacity of providing treatment or care 

6 to the participant or beneficiary. Nothing 

7 in the preceding sentence shall be con8 strued to preempt vicarious liability of any 

9 plan, plan sponsor, health insurance issuer, 

10 or managed care entity. 

11 ‘‘(3) 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) 

16 does not apply with respect to—

17 ‘‘(i) any cause of action against an 

18 employer or other plan sponsor maintain19 ing the plan (or against an employee of 

20 such an employer or sponsor acting within 

21 the scope of employment), or 

22 ‘‘(ii) a right of recovery, indemnity, or 

23 contribution by a person against an em24 ployer or other plan sponsor (or such an 

25 employee) for damages assessed against 
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1 the person pursuant to a cause of action to 

2 which paragraph (1) applies. 

3 ‘‘(B) CERTAIN CAUSES OF ACTION PER4 MITTED.—Notwithstanding subparagraph (A), 

5 paragraph (1) applies with respect to any cause 

6 of action that is brought by a participant or 

7 beneficiary under a group health plan (or the 

8 estate of such a participant or beneficiary) to 

9 recover damages resulting from personal injury 

10 or for wrongful death against any employer or 

11 other plan sponsor maintaining the plan (or 

12 against an employee of such an employer or 

13 sponsor acting within the scope of employment) 

14 if such cause of action arises by reason of a 

15 medically reviewable decision, to the extent that 

16 there was direct participation by the employer 

17 or other plan sponsor (or employee) in the deci18 sion. 

19 ‘‘(C) DIRECT PARTICIPATION.—

20 ‘‘(i) DIRECT PARTICIPATION IN DECI21 SIONS.—For purposes of subparagraph 

22 (B), the term ‘direct participation’ means, 

23 in connection with a decision described in 

24 subparagraph (B), the actual making of 

25 such decision or the actual exercise of con-
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1 trol in making such decision or in the con2 duct constituting the failure. 

3 ‘‘(ii) RULES OF CONSTRUCTION.—For 

4 purposes of clause (i), the employer or plan 

5 sponsor (or employee) shall not be con6 strued to be engaged in direct participation 

7 because of any form of decisionmaking or 

8 other conduct that is merely collateral or 

9 precedent to the decision described in sub10 paragraph (B) on a particular claim for 

11 benefits of a particular participant or bene12 ficiary, including (but not limited to)—

13 ‘‘(I) any participation by the em14 ployer or other plan sponsor (or em15 ployee) in the selection of the group 

16 health plan or health insurance cov17 erage involved or the third party ad18 ministrator or other agent; 

19 ‘‘(II) any engagement by the em20 ployer or other plan sponsor (or em21 ployee) in any cost-benefit analysis 

22 undertaken in connection with the se23 lection of, or continued maintenance 

24 of, the plan or coverage involved; 
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1 ‘‘(III) any participation by the 

2 employer or other plan sponsor (or 

3 employee) in the process of creating, 

4 continuing, modifying, or terminating 

5 the plan or any benefit under the 

6 plan, if such process was not substan7 tially focused solely on the particular 

8 situation of the participant or bene9 ficiary referred to in paragraph 

10 (1)(A); and 

11 ‘‘(IV) any participation by the 

12 employer or other plan sponsor (or 

13 employee) in the design of any benefit 

14 under the plan, including the amount 

15 of copayment and limits connected 

16 with such benefit. 

17 ‘‘(iv) IRRELEVANCE OF CERTAIN COL18 LATERAL EFFORTS MADE BY EMPLOYER

19 OR PLAN SPONSOR.—For purposes of this 

20 subparagraph, an employer or plan sponsor 

21 shall not be treated as engaged in direct 

22 participation in a decision with respect to 

23 any claim for benefits or denial thereof in 

24 the case of any particular participant or 

25 beneficiary solely by reason of—
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1 ‘‘(I) any efforts that may have 

2 been made by the employer or plan 

3 sponsor to advocate for authorization 

4 of coverage for that or any other par5 ticipant or beneficiary (or any group 

6 of participants or beneficiaries), or 

7 ‘‘(II) any provision that may 

8 have been made by the employer or 

9 plan sponsor for benefits which are 

10 not covered under the terms and con11 ditions of the plan for that or any 

12 other participant or beneficiary (or 

13 any group of participants or bene14 ficiaries). 

15 ‘‘(4) REQUIREMENT OF EXHAUSTION.—

16 ‘‘(A) IN GENERAL.—Except as provided in 

17 subparagraph (D), a cause of action may not be 

18 brought under paragraph (1) in connection with 

19 any denial of a claim for benefits of any indi20 vidual until all administrative processes under 

21 sections 102, 103, and 104 of the Patients’ Bill 

22 of Rights Act of 2004 (if applicable) have been 

23 exhausted. 

24 ‘‘(B) LATE MANIFESTATION OF INJURY.—
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1 ‘‘(i) IN GENERAL.—A participant or 

2 beneficiary shall not be precluded from 

3 pursuing a review under section 104 of the 

4 Patients’ Bill of Rights Act of 2004 re5 garding an injury that such participant or 

6 beneficiary has experienced if the external 

7 review entity first determines that the in8 jury of such participant or beneficiary is a 

9 late manifestation of an earlier injury. 

10 ‘‘(ii) DEFINITION.—In this subpara11 graph, the term ‘late manifestation of an 

12 earlier injury’ means an injury sustained 

13 by the participant or beneficiary which was 

14 not known, and should not have been 

15 known, by such participant or beneficiary 

16 by the latest date that the requirements of 

17 subparagraph (A) should have been met 

18 regarding the claim for benefits which was 

19 denied. 

20 ‘‘(C) EXCEPTION FOR NEEDED CARE.—A 

21 participant or beneficiary may seek relief exclu22 sively in Federal court under subsection 

23 502(a)(1)(B) prior to the exhaustion of admin24 istrative remedies under sections 102, 103, or 

25 104 of the Patients’ Bill of Rights Act of 2004 
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1 (as required under subparagraph (A)) if it is 

2 demonstrated to the court that the exhaustion 

3 of such remedies would cause irreparable harm 

4 to the health of the participant or beneficiary. 

5 Notwithstanding the awarding of relief under 

6 subsection 502(a)(1)(B) pursuant to this sub7 paragraph, no relief shall be available as a re8 sult of, or arising under, paragraph (1)(A) un9 less the requirements of subparagraph (A) are 

10 met. 

11 ‘‘(D) FAILURE TO REVIEW.—

12 ‘‘(i) IN GENERAL.—If the external re13 view entity fails to make a determination 

14 within the time required under section 

15 104(e)(1)(A)(i), a participant or bene16 ficiary may bring an action under section 

17 514(d) after 10 additional days after the 

18 date on which such time period has expired 

19 and the filing of such action shall not af20 fect the duty of the independent medical 

21 reviewer (or reviewers) to make a deter22 mination pursuant to section 

23 104(e)(1)(A)(i). 

24 ‘‘(ii) EXPEDITED DETERMINATION.—

25 If the external review entity fails to make 
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1 a determination within the time required 

2 under section 104(e)(1)(A)(ii), a partici3 pant or beneficiary may bring an action 

4 under this subsection and the filing of such 

5 an action shall not affect the duty of the 

6 independent medical reviewer (or review7 ers) to make a determination pursuant to 

8 section 104(e)(1)(A)(ii). 

9 ‘‘(E) RECEIPT OF BENEFITS DURING AP10 PEALS PROCESS.—Receipt by the participant or 

11 beneficiary of the benefits involved in the claim 

12 for benefits during the pendency of any admin13 istrative processes referred to in subparagraph 

14 (A) or of any action commenced under this sub15 section—

16 ‘‘(i) shall not preclude continuation of 

17 all such administrative processes to their 

18 conclusion if so moved by any party, and 

19 ‘‘(ii) shall not preclude any liability 

20 under subsection (a)(1)(C) and this sub21 section in connection with such claim. 

22 ‘‘(F) ADMISSIBLE.—Any determination 

23 made by a reviewer in an administrative pro24 ceeding under section 104 of the Patients’ Bill 

25 of Rights Act of 2004 shall be admissible in 
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1 any Federal or State court proceeding and shall 

2 be presented to the trier of fact. 

3 ‘‘(5) TOLLING PROVISION.—The statute of limi4 tations for any cause of action arising under section 

5 502(n) relating to a denial of a claim for benefits 

6 that is the subject of an action brought in State 

7 court shall be tolled until such time as the State 

8 court makes a final disposition, including all ap9 peals, of whether such claim should properly be 

10 within the jurisdiction of the State court. The tolling 

11 period shall be determined by the applicable Federal 

12 or State law, whichever period is greater. 

13 ‘‘(6) EXCLUSION OF DIRECTED RECORD14 KEEPERS.—

15 ‘‘(A) IN GENERAL.—Subject to subpara16 graph (C), paragraph (1) shall not apply with 

17 respect to a directed recordkeeper in connection 

18 with a group health plan. 

19 ‘‘(B) DIRECTED RECORDKEEPER.—For 

20 purposes of this paragraph, the term ‘directed 

21 recordkeeper’ means, in connection with a 

22 group health plan, a person engaged in directed 

23 recordkeeping activities pursuant to the specific 

24 instructions of the plan or the employer or 

25 other plan sponsor, including the distribution of 
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1 enrollment information and distribution of dis2 closure materials under this Act or title I of the 

3 Patients’ Bill of Rights Act of 2004 and whose 

4 duties do not include making decisions on 

5 claims for benefits. 

6 ‘‘(C) LIMITATION.—Subparagraph (A) 

7 does not apply in connection with any directed 

8 recordkeeper to the extent that the directed rec9 ordkeeper fails to follow the specific instruction 

10 of the plan or the employer or other plan spon11 sor. 

12 ‘‘(7) CONSTRUCTION.—Nothing in this sub13 section shall be construed as—

14 ‘‘(A) saving from preemption a cause of 

15 action under State law for the failure to provide 

16 a benefit for an item or service which is specifi17 cally excluded under the group health plan in18 volved, except to the extent that—

19 ‘‘(i) the application or interpretation 

20 of the exclusion involves a determination 

21 described in section 104(d)(2) of the Pa22 tients’ Bill of Rights Act of 2004, or 

23 ‘‘(ii) the provision of the benefit for 

24 the item or service is required under Fed-
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1 eral law or under applicable State law con2 sistent with subsection (b)(2)(B); 

3 ‘‘(B) preempting a State law which re4 quires an affidavit or certificate of merit in a 

5 civil action; 

6 ‘‘(C) affecting a cause of action or remedy 

7 under State law in connection with the provi8 sion or arrangement of excepted benefits (as de9 fined in section 733(c)), other than those de10 scribed in section 733(c)(2)(A); or 

11 ‘‘(D) affecting a cause of action under 

12 State law other than a cause of action described 

13 in paragraph (1)(A). 

14 ‘‘(8) PURCHASE OF INSURANCE TO COVER LI15 ABILITY.—Nothing in section 410 shall be construed 

16 to preclude the purchase by a group health plan of 

17 insurance to cover any liability or losses arising 

18 under a cause of action described in paragraph 

19 (1)(A). 

20 ‘‘(9) RELIEF FROM LIABILITY FOR EMPLOYER

21 OR OTHER PLAN SPONSOR BY MEANS OF DES22 IGNATED DECISIONMAKER.—

23 ‘‘(A) IN GENERAL.—Paragraph (1) shall 

24 not apply with respect to any cause of action 

25 described in paragraph (1)(A) under State law 
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1 insofar as such cause of action provides for li2 ability with respect to a participant or bene3 ficiary of an employer or plan sponsor (or an 

4 employee of such employer or sponsor acting 

5 within the scope of employment), if with respect 

6 to the employer or plan sponsor there is (or is 

7 deemed under subparagraph (B) to be) a des8 ignated decisionmaker that meets the require9 ments of section 502(o)(1) with respect to such 

10 participant or beneficiary. Such paragraph (1) 

11 shall apply with respect to any cause of action 

12 described in paragraph (1)(A) under State law 

13 against the designated decisionmaker of such 

14 employer or other plan sponsor with respect to 

15 the participant or beneficiary. 

16 ‘‘(B) AUTOMATIC DESIGNATION.—A health 

17 insurance issuer shall be deemed to be a des18 ignated decisionmaker for purposes of subpara19 graph (A) with respect to the participants and 

20 beneficiaries of an employer or plan sponsor, 

21 whether or not the employer or plan sponsor 

22 makes such a designation, and shall be deemed 

23 to have assumed unconditionally all liability of 

24 the employer or plan sponsor under such des25 ignation in accordance with subsection (o), un-
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1 less the employer or plan sponsor affirmatively 

2 enters into a contract to prevent the service of 

3 the designated decisionmaker. 

4 ‘‘(C) TREATMENT OF CERTAIN TRUST

5 FUNDS.—For purposes of this paragraph, the 

6 terms ‘employer’ and ‘plan sponsor’, in connec7 tion with the assumption by a designated deci8 sionmaker of the liability of employer or other 

9 plan sponsor pursuant to this paragraph, shall 

10 be construed to include a trust fund maintained 

11 pursuant to section 302 of the Labor Manage12 ment Relations Act, 1947 (29 U.S.C. 186) or 

13 the Railway Labor Act (45 U.S.C. 151 et seq.). 

14 ‘‘(10) PREVIOUSLY PROVIDED SERVICES.—

15 ‘‘(A) IN GENERAL.—Except as provided in 

16 this paragraph, a cause of action shall not arise 

17 under paragraph (1) where the denial involved 

18 relates to an item or service that has already 

19 been fully provided to the participant or bene20 ficiary under the plan or coverage and the claim 

21 relates solely to the subsequent denial of pay22 ment for the provision of such item or service. 

23 ‘‘(B) EXCEPTION.—Nothing in subpara24 graph (A) shall be construed to—
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1 ‘‘(i) prohibit a cause of action under 

2 paragraph (1) where the nonpayment in3 volved results in the participant or bene4 ficiary being unable to receive further 

5 items or services that are directly related 

6 to the item or service involved in the denial 

7 referred to in subparagraph (A) or that 

8 are part of a continuing treatment or se9 ries of procedures; 

10 ‘‘(ii) prohibit a cause of action under 

11 paragraph (1) relating to quality of care; 

12 or 

13 ‘‘(iii) limit liability that otherwise 

14 would arise from the provision of the item 

15 or services or the performance of a medical 

16 procedure. 

17 ‘‘(11) EXEMPTION FROM PERSONAL LIABILITY

18 FOR INDIVIDUAL MEMBERS OF BOARDS OF DIREC19 TORS, JOINT BOARDS OF TRUSTEES, ETC.—Any indi20 vidual who is—

21 ‘‘(A) a member of a board of directors of 

22 an employer or plan sponsor; or 

23 ‘‘(B) a member of an association, com24 mittee, employee organization, joint board of 

25 trustees, or other similar group of representa-
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1 tives of the entities that are the plan sponsor 

2 of plan maintained by two or more employers 

3 and one or more employee organizations; 

4 shall not be personally liable under this subsection 

5 for conduct that is within the scope of employment 

6 or of plan-related duties of the individuals unless the 

7 individual acts in a fraudulent manner for personal 

8 enrichment. 

9 ‘‘(12) CHOICE OF LAW.—A cause of action 

10 brought under paragraph (1) shall be governed by 

11 the law (including choice of law rules) of the State 

12 in which the plaintiff resides. 

13 ‘‘(13) LIMITATION ON ATTORNEYS’ FEES.—

14 ‘‘(A) IN GENERAL.—Notwithstanding any 

15 other provision of law, or any arrangement, 

16 agreement, or contract regarding an attorney’s 

17 fee, the amount of an attorney’s contingency fee 

18 allowable for a cause of action brought under 

paragraph (1) shall not exceed 1 19 ⁄3 of the total 

20 amount of the plaintiff’s recovery (not including 

21 the reimbursement of actual out-of-pocket ex22 penses of the attorney). 

23 ‘‘(B) DETERMINATION BY COURT.—The 

24 last court in which the action was pending upon 

25 the final disposition, including all appeals, of 
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1 the action may review the attorney’s fee to en2 sure that the fee is a reasonable one. 

3 ‘‘(C) NO PREEMPTION OF STATE LAW.—

4 Subparagraph (A) shall not apply with respect 

5 to a cause of action under paragraph (1) that 

6 is brought in a State that has a law or frame7 work of laws with respect to the amount of an 

8 attorney’s contingency fee that may be incurred 

9 for the representation of a participant or bene10 ficiary (or the estate of such participant or ben11 eficiary) who brings such a cause of action. 

12 ‘‘(e) RULES OF CONSTRUCTION RELATING TO

13 HEALTH CARE.—Nothing in this title shall be construed 

14 as—

15 ‘‘(1) affecting any State law relating to the 

16 practice of medicine or the provision of, or the fail17 ure to provide, medical care, or affecting any action 

18 (whether the liability is direct or vicarious) based 

19 upon such a State law, 

20 ‘‘(2) superseding any State law permitted under 

21 section 152(b)(1)(A) of the Patients’ Bill of Rights 

22 Act of 2004, or 

23 ‘‘(3) affecting any applicable State law with re24 spect to limitations on monetary damages. 
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1 ‘‘(f) NO RIGHT OF ACTION FOR RECOVERY, INDEM2 NITY, OR CONTRIBUTION BY ISSUERS AGAINST TREATING

3 HEALTH CARE PROFESSIONALS AND TREATING HOS4 PITALS.—In the case of any care provided, or any treat5 ment decision made, by the treating health care profes6 sional or the treating hospital of a participant or bene7 ficiary under a group health plan which consists of medical 

8 care provided under such plan, any cause of action under 

9 State law against the treating health care professional or 

10 the treating hospital by the plan or a health insurance 

11 issuer providing health insurance coverage in connection 

12 with the plan for recovery, indemnity, or contribution in 

13 connection with such care (or any medically reviewable de14 cision made in connection with such care) or such treat15 ment decision is superseded.’’. 

16 (c) EFFECTIVE DATE.—The amendments made by 

17 this section shall apply to acts and omissions (from which 

18 a cause of action arises) occurring on or after the applica19 ble effective date under section 601. 

20 SEC. 403. COOPERATION BETWEEN FEDERAL AND STATE 

21 AUTHORITIES. 

22 Subpart C of part 7 of subtitle B of title I of the 

23 Employee Retirement Income Security Act of 1974 (29 

24 U.S.C. 1191 et seq.) is amended by adding at the end 

25 the following new section: 
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1 ‘‘SEC. 735. COOPERATION BETWEEN FEDERAL AND STATE 

2 AUTHORITIES. 

3 ‘‘(a) AGREEMENT WITH STATES.—A State may 

4 enter into an agreement with the Secretary for the delega5 tion to the State of some or all of the Secretary’s authority 

6 under this title to enforce the requirements applicable 

7 under title I of the Patients’ Bill of Rights Act of 2004 

8 with respect to health insurance coverage offered by a 

9 health insurance issuer and with respect to a group health 

10 plan that is a non-Federal governmental plan. 

11 ‘‘(b) DELEGATIONS.—Any department, agency, or in12 strumentality of a State to which authority is delegated 

13 pursuant to an agreement entered into under this section 

14 may, if authorized under State law and to the extent con15 sistent with such agreement, exercise the powers of the 

16 Secretary under this title which relate to such authority.’’. 

17 TITLE V—AMENDMENTS TO THE 

18 INTERNAL REVENUE CODE 

19 OF 1986

20 Subtitle A—Application of Patient 

21 Protection Provisions 

22 SEC. 501. APPLICATION TO GROUP HEALTH PLANS UNDER 

23 THE INTERNAL REVENUE CODE OF 1986. 

24 Subchapter B of chapter 100 of the Internal Revenue 

25 Code of 1986 is amended—
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1 (1) in the table of sections, by inserting after 

2 the item relating to section 9812 the following new 

3 item:

‘‘9813. Standard relating to patients’ bill of rights.’’;

4 and 

5 (2) by inserting after section 9812 the fol6 lowing: 

7 ‘‘SEC. 9813. STANDARD RELATING TO PATIENTS’ BILL OF 

8 RIGHTS. 

9 ‘‘A group health plan shall comply with the require10 ments of title I of the Patients’ Bill of Rights Act of 2004 

11 (as in effect as of the date of the enactment of such Act), 

12 and such requirements shall be deemed to be incorporated 

13 into this section.’’. 

14 SEC. 502. CONFORMING ENFORCEMENT FOR WOMEN’S 

15 HEALTH AND CANCER RIGHTS. 

16 Subchapter B of chapter 100 of the Internal Revenue 

17 Code of 1986, as amended by section 501, is further 

18 amended—

19 (1) in the table of sections, by inserting after 

20 the item relating to section 9813 the following new 

21 item:

‘‘9814. Standard relating to women’s health and cancer rights.’’;

22 and 

23 (2) by inserting after section 9813 the fol24 lowing: 
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1 ‘‘SEC. 9814. STANDARD RELATING TO WOMEN’S HEALTH 

2 AND CANCER RIGHTS. 

3 ‘‘The provisions of section 713 of the Employee Re4 tirement Income Security Act of 1974 (as in effect as of 

5 the date of the enactment of this section) shall apply to 

6 group health plans as if included in this subchapter.’’. 

7 Subtitle B—Health Care Coverage 

8 Access Tax Incentives 

9 SEC. 511. CREDIT FOR HEALTH INSURANCE EXPENSES OF 

10 SMALL BUSINESSES. 

11 (a) IN GENERAL.—Subpart D of part IV of sub12 chapter A of chapter 1 of the Internal Revenue Code of 

13 1986 (relating to business-related credits) is amended by 

14 adding at the end the following: 

15 ‘‘SEC. 45E. SMALL BUSINESS HEALTH INSURANCE EX16 PENSES. 

17 ‘‘(a) GENERAL RULE.—For purposes of section 38, 

18 in the case of a small employer, the health insurance credit 

19 determined under this section for the taxable year is an 

20 amount equal to the applicable percentage of the expenses 

21 paid by the taxpayer during the taxable year for health 

22 insurance coverage for such year provided under a new 

23 health plan for employees of such employer. 

24 ‘‘(b) APPLICABLE PERCENTAGE.—For purposes of 

25 subsection (a), the applicable percentage is—
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1 ‘‘(1) in the case of insurance purchased as a 

2 member of a qualified health benefit purchasing coa3 lition (as defined in section 9841), 30 percent, and 

4 ‘‘(2) in the case of insurance not described in 

5 paragraph (1), 20 percent. 

6 ‘‘(c) LIMITATIONS.—

7 ‘‘(1) PER EMPLOYEE DOLLAR LIMITATION.—

8 The amount of expenses taken into account under 

9 subsection (a) with respect to any employee for any 

10 taxable year shall not exceed—

11 ‘‘(A) $2,000 in the case of self-only cov12 erage, and 

13 ‘‘(B) $5,000 in the case of family coverage. 

14 In the case of an employee who is covered by a new 

15 health plan of the employer for only a portion of 

16 such taxable year, the limitation under the preceding 

17 sentence shall be an amount which bears the same 

18 ratio to such limitation (determined without regard 

19 to this sentence) as such portion bears to the entire 

20 taxable year. 

21 ‘‘(2) PERIOD OF COVERAGE.—Expenses may be 

22 taken into account under subsection (a) only with 

23 respect to coverage for the 4-year period beginning 

24 on the date the employer establishes a new health 

25 plan. 
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1 ‘‘(d) DEFINITIONS.—For purposes of this section—

2 ‘‘(1) HEALTH INSURANCE COVERAGE.—The 

3 term ‘health insurance coverage’ has the meaning 

4 given such term by section 9832(b)(1). 

5 ‘‘(2) NEW HEALTH PLAN.—

6 ‘‘(A) IN GENERAL.—The term ‘new health 

7 plan’ means any arrangement of the employer 

8 which provides health insurance coverage to em9 ployees if—

10 ‘‘(i) such employer (and any prede11 cessor employer) did not establish or main12 tain such arrangement (or any similar ar13 rangement) at any time during the 2 tax14 able years ending prior to the taxable year 

15 in which the credit under this section is 

16 first allowed, and 

17 ‘‘(ii) such arrangement provides 

18 health insurance coverage to at least 70 

19 percent of the qualified employees of such 

20 employer. 

21 ‘‘(B) QUALIFIED EMPLOYEE.—

22 ‘‘(i) IN GENERAL.—The term ‘quali23 fied employee’ means any employee of an 

24 employer if the annual rate of such em-
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1 ployee’s compensation (as defined in sec2 tion 414(s)) exceeds $10,000. 

3 ‘‘(ii) TREATMENT OF CERTAIN EM4 PLOYEES.—The term ‘employee’ shall in5 clude a leased employee within the mean6 ing of section 414(n). 

7 ‘‘(3) SMALL EMPLOYER.—The term ‘small em8 ployer’ has the meaning given to such term by sec9 tion 4980D(d)(2); except that only qualified employ10 ees shall be taken into account. 

11 ‘‘(e) SPECIAL RULES.—

12 ‘‘(1) CERTAIN RULES MADE APPLICABLE.—For 

13 purposes of this section, rules similar to the rules of 

14 section 52 shall apply. 

15 ‘‘(2) AMOUNTS PAID UNDER SALARY REDUC16 TION ARRANGEMENTS.—No amount paid or incurred 

17 pursuant to a salary reduction arrangement shall be 

18 taken into account under subsection (a). 

19 ‘‘(f) TERMINATION.—This section shall not apply to 

20 expenses paid or incurred by an employer with respect to 

21 any arrangement established on or after January 1, 

22 2013.’’. 

23 (b) CREDIT TO BE PART OF GENERAL BUSINESS

24 CREDIT.—Section 38(b) of such Code (relating to current 

25 year business credit) is amended by striking ‘‘plus’’ at the 
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1 end of paragraph (12), by striking the period at the end 

2 of paragraph (13) and inserting ‘‘, plus’’, and by adding 

3 at the end the following: 

4 ‘‘(14) in the case of a small employer (as de5 fined in section 45E(d)(3)), the health insurance 

6 credit determined under section 45E(a).’’. 

7 (c) NO CARRYBACKS.—Subsection (d) of section 39 

8 of such Code (relating to carryback and carryforward of 

9 unused credits) is amended by adding at the end the fol10 lowing: 

11 ‘‘(10) NO CARRYBACK OF SECTION 45E CREDIT

12 BEFORE EFFECTIVE DATE.—No portion of the un13 used business credit for any taxable year which is 

14 attributable to the employee health insurance ex15 penses credit determined under section 45E may be 

16 carried back to a taxable year ending before the date 

17 of the enactment of section 45E.’’. 

18 (d) DENIAL OF DOUBLE BENEFIT.—Section 280C of 

19 such Code is amended by adding at the end the following 

20 new subsection: 

21 ‘‘(d) CREDIT FOR SMALL BUSINESS HEALTH INSUR22 ANCE EXPENSES.—

23 ‘‘(1) IN GENERAL.—No deduction shall be al24 lowed for that portion of the expenses (otherwise al25 lowable as a deduction) taken into account in deter-
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1 mining the credit under section 45E for the taxable 

2 year which is equal to the amount of the credit de3 termined for such taxable year under section 

4 45E(a). 

5 ‘‘(2) CONTROLLED GROUPS.—Persons treated 

6 as a single employer under subsection (a) or (b) of 

7 section 52 shall be treated as 1 person for purposes 

8 of this section.’’. 

9 (e) CLERICAL AMENDMENT.—The table of sections 

10 for subpart D of part IV of subchapter A of chapter 1 

11 of such Code is amended by adding at the end the fol12 lowing:

‘‘45E. Small business health insurance expenses.’’.

13 (f) EFFECTIVE DATE.—The amendments made by 

14 this section shall apply to amounts paid or incurred in tax15 able years beginning after December 31, 2004, for ar16 rangements established after the date of the enactment 

17 of this Act. 

18 SEC. 512. CERTAIN GRANTS BY PRIVATE FOUNDATIONS TO 

19 QUALIFIED HEALTH BENEFIT PURCHASING 

20 COALITIONS. 

21 (a) IN GENERAL.—Section 4942 of the Internal Rev22 enue Code of 1986 (relating to taxes on failure to dis23 tribute income) is amended by adding at the end the fol24 lowing: 
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1 ‘‘(k) CERTAIN QUALIFIED HEALTH BENEFIT PUR2 CHASING COALITION DISTRIBUTIONS.—

3 ‘‘(1) IN GENERAL.—For purposes of subsection 

4 (g), sections 170, 501, 507, 509, and 2522, and this 

5 chapter, a qualified health benefit purchasing coali6 tion distribution by a private foundation shall be 

7 considered to be a distribution for a charitable pur8 pose. 

9 ‘‘(2) QUALIFIED HEALTH BENEFIT PUR10 CHASING COALITION DISTRIBUTION.—For purposes 

11 of paragraph (1)—

12 ‘‘(A) IN GENERAL.—The term ‘qualified 

13 health benefit purchasing coalition distribution’ 

14 means any amount paid or incurred by a pri15 vate foundation to or on behalf of a qualified 

16 health benefit purchasing coalition (as defined 

17 in section 9841) for purposes of payment or re18 imbursement of amounts paid or incurred in 

19 connection with the establishment and mainte20 nance of such coalition. 

21 ‘‘(B) EXCLUSIONS.—Such term shall not 

22 include any amount used by a qualified health 

23 benefit purchasing coalition (as so defined)—

24 ‘‘(i) for the purchase of real property, 
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1 ‘‘(ii) as payment to, or for the benefit 

2 of, members (or employees or affiliates of 

3 such members) of such coalition, or 

4 ‘‘(iii) for any expense paid or incurred 

5 more than 48 months after the date of es6 tablishment of such coalition. 

7 ‘‘(3) TERMINATION.—This subsection shall not 

8 apply—

9 ‘‘(A) to qualified health benefit purchasing 

10 coalition distributions paid or incurred after 

11 December 31, 2012, and 

12 ‘‘(B) with respect to start-up costs of a co13 alition which are paid or incurred after Decem14 ber 31, 2013.’’. 

15 (b) QUALIFIED HEALTH BENEFIT PURCHASING CO16 ALITION.—

17 (1) IN GENERAL.—Chapter 100 of such Code 

18 (relating to group health plan requirements) is 

19 amended by adding at the end the following new 

20 subchapter: 

21 ‘‘Subchapter D—Qualified Health Benefit 

22 Purchasing Coalition

‘‘Sec. 9841. Qualified health benefit purchasing coalition.
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1 ‘‘SEC. 9841. QUALIFIED HEALTH BENEFIT PURCHASING CO2 ALITION. 

3 ‘‘(a) IN GENERAL.—A qualified health benefit pur4 chasing coalition is a private not-for-profit corporation 

5 which—

6 ‘‘(1) sells health insurance through State li7 censed health insurance issuers in the State in which 

8 the employers to which such coalition is providing 

9 insurance are located, and 

10 ‘‘(2) establishes to the Secretary, under State 

11 certification procedures or other procedures as the 

12 Secretary may provide by regulation, that such coali13 tion meets the requirements of this section. 

14 ‘‘(b) BOARD OF DIRECTORS.—

15 ‘‘(1) IN GENERAL.—Each purchasing coalition 

16 under this section shall be governed by a Board of 

17 Directors. 

18 ‘‘(2) ELECTION.—The Secretary shall establish 

19 procedures governing election of such Board. 

20 ‘‘(3) MEMBERSHIP.—The Board of Directors 

21 shall—

22 ‘‘(A) be composed of representatives of the 

23 members of the coalition, in equal number, in24 cluding small employers and employee rep25 resentatives of such employers, but 
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1 ‘‘(B) not include other interested parties, 

2 such as service providers, health insurers, or in3 surance agents or brokers which may have a 

4 conflict of interest with the purposes of the coa5 lition. 

6 ‘‘(c) MEMBERSHIP OF COALITION.—

7 ‘‘(1) IN GENERAL.—A purchasing coalition 

8 shall accept all small employers residing within the 

9 area served by the coalition as members if such em10 ployers request such membership. 

11 ‘‘(2) OTHER MEMBERS.—The coalition, at the 

12 discretion of its Board of Directors, may be open to 

13 individuals and large employers. 

14 ‘‘(3) VOTING.—Members of a purchasing coali15 tion shall have voting rights consistent with the rules 

16 established by the State. 

17 ‘‘(d) DUTIES OF PURCHASING COALITIONS.—Each 

18 purchasing coalition shall—

19 ‘‘(1) enter into agreements with small employ20 ers (and, at the discretion of its Board, with individ21 uals and other employers) to provide health insur22 ance benefits to employees and retirees of such em23 ployers, 
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1 ‘‘(2) where feasible, enter into agreements with 

2 3 or more unaffiliated, qualified licensed health 

3 plans, to offer benefits to members, 

4 ‘‘(3) offer to members at least 1 open enroll5 ment period of at least 30 days per calendar year, 

6 ‘‘(4) serve a significant geographical area and 

7 market to all eligible members in that area, and 

8 ‘‘(5) carry out other functions provided for 

9 under this section. 

10 ‘‘(e) LIMITATION ON ACTIVITIES.—A purchasing coa11 lition shall not—

12 ‘‘(1) perform any activity (including certifi13 cation or enforcement) relating to compliance or li14 censing of health plans, 

15 ‘‘(2) assume insurance or financial risk in rela16 tion to any health plan, or 

17 ‘‘(3) perform other activities identified by the 

18 State as being inconsistent with the performance of 

19 its duties under this section. 

20 ‘‘(f) ADDITIONAL REQUIREMENTS FOR PURCHASING

21 COALITIONS.—As provided by the Secretary in regula22 tions, a purchasing coalition shall be subject to require23 ments similar to the requirements of a group health plan 

24 under this chapter. 

25 ‘‘(g) RELATION TO OTHER LAWS.—
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1 ‘‘(1) PREEMPTION OF STATE FICTITIOUS

2 GROUP LAWS.—Requirements (commonly referred to 

3 as fictitious group laws) relating to grouping and 

4 similar requirements for health insurance coverage 

5 are preempted to the extent such requirements im6 pede the establishment and operation of qualified 

7 health benefit purchasing coalitions. 

8 ‘‘(2) ALLOWING SAVINGS TO BE PASSED

9 THROUGH.—Any State law that prohibits health in10 surance issuers from reducing premiums on health 

11 insurance coverage sold through a qualified health 

12 benefit purchasing coalition to reflect administrative 

13 savings is preempted. This paragraph shall not be 

14 construed to preempt State laws that impose restric15 tions on premiums based on health status, claims 

16 history, industry, age, gender, or other underwriting 

17 factors. 

18 ‘‘(3) NO WAIVER OF HIPAA REQUIREMENTS.—

19 Nothing in this section shall be construed to change 

20 the obligation of health insurance issuers to comply 

21 with the requirements of title XXVII of the Public 

22 Health Service Act with respect to health insurance 

23 coverage offered to small employers in the small 

24 group market through a qualified health benefit pur25 chasing coalition. 
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1 ‘‘(h) DEFINITION OF SMALL EMPLOYER.—For pur2 poses of this section—

3 ‘‘(1) IN GENERAL.—The term ‘small employer’ 

4 means, with respect to any calendar year, any em5 ployer if such employer employed an average of at 

6 least 2 and not more than 50 qualified employees on 

7 business days during either of the 2 preceding cal8 endar years. For purposes of the preceding sentence, 

9 a preceding calendar year may be taken into account 

10 only if the employer was in existence throughout 

11 such year. 

12 ‘‘(2) EMPLOYERS NOT IN EXISTENCE IN PRE13 CEDING YEAR.—In the case of an employer which 

14 was not in existence throughout the 1st preceding 

15 calendar year, the determination under paragraph 

16 (1) shall be based on the average number of quali17 fied employees that it is reasonably expected such 

18 employer will employ on business days in the current 

19 calendar year.’’. 

20 (2) CONFORMING AMENDMENT.—The table of 

21 subchapters for chapter 100 of such Code is amend22 ed by adding at the end the following item:

‘‘SUBCHAPTER D. QUALIFIED HEALTH BENEFIT PURCHASING COALITION’’.

23 (c) EFFECTIVE DATE.—The amendment made by 

24 subsection (a) shall apply to taxable years beginning after 

25 December 31, 2001. 
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1 SEC. 513. STATE GRANT PROGRAM FOR MARKET INNOVA2 TION. 

3 (a) IN GENERAL.—The Secretary of Health and 

4 Human Services (in this section referred to as the ‘‘Sec5 retary’’) shall establish a program (in this section referred 

6 to as the ‘‘program’’) to award demonstration grants 

7 under this section to States to allow States to demonstrate 

8 the effectiveness of innovative ways to increase access to 

9 health insurance through market reforms and other inno10 vative means. Such innovative means may include (and are 

11 not limited to) any of the following: 

12 (1) Alternative group purchasing or pooling ar13 rangements, such as purchasing cooperatives for 

14 small businesses, reinsurance pools, or high risk 

15 pools. 

16 (2) Individual or small group market reforms. 

17 (3) Consumer education and outreach. 

18 (4) Subsidies to individuals, employers, or both, 

19 in obtaining health insurance. 

20 (b) SCOPE; DURATION.—The program shall be lim21 ited to not more than 10 States and to a total period of 

22 5 years, beginning on the date the first demonstration 

23 grant is made. 

24 (c) CONDITIONS FOR DEMONSTRATION GRANTS.—

25 (1) IN GENERAL.—The Secretary may not pro26 vide for a demonstration grant to a State under the 
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1 program unless the Secretary finds that under the 

2 proposed demonstration grant—

3 (A) the State will provide for demonstrated 

4 increase of access for some portion of the exist5 ing uninsured population through a market in6 novation (other than merely through a financial 

7 expansion of a program initiated before the 

8 date of the enactment of this Act); 

9 (B) the State will comply with applicable 

10 Federal laws; 

11 (C) the State will not discriminate among 

12 participants on the basis of any health status13 related factor (as defined in section 2791(d)(9) 

14 of the Public Health Service Act), except to the 

15 extent a State wishes to focus on populations 

16 that otherwise would not obtain health insur17 ance because of such factors; and 

18 (D) the State will provide for such evalua19 tion, in coordination with the evaluation re20 quired under subsection (d), as the Secretary 

21 may specify. 

22 (2) APPLICATION.—The Secretary shall not 

23 provide a demonstration grant under the program to 

24 a State unless—
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1 (A) the State submits to the Secretary 

2 such an application, in such a form and man3 ner, as the Secretary specifies; 

4 (B) the application includes information 

5 regarding how the demonstration grant will ad6 dress issues such as governance, targeted popu7 lation, expected cost, and the continuation after 

8 the completion of the demonstration grant pe9 riod; and 

10 (C) the Secretary determines that the dem11 onstration grant will be used consistent with 

12 this section. 

13 (3) FOCUS.—A demonstration grant proposal 

14 under section need not cover all uninsured individ15 uals in a State or all health care benefits with re16 spect to such individuals. 

17 (d) EVALUATION.—The Secretary shall enter into a 

18 contract with an appropriate entity outside the Depart19 ment of Health and Human Services to conduct an overall 

20 evaluation of the program at the end of the program pe21 riod. Such evaluation shall include an analysis of improve22 ments in access, costs, quality of care, or choice of cov23 erage, under different demonstration grants. 

24 (e) OPTION TO PROVIDE FOR INITIAL PLANNING

25 GRANTS.—Notwithstanding the previous provisions of this 
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1 section, under the program the Secretary may provide for 

2 a portion of the amounts appropriated under subsection 

3 (f) (not to exceed $5,000,000) to be made available to any 

4 State for initial planning grants to permit States to de5 velop demonstration grant proposals under the previous 

6 provisions of this section. 

7 (f) AUTHORIZATION OF APPROPRIATIONS.—There 

8 are authorized to be appropriated $100,000,000 for each 

9 fiscal year to carry out this section. Amounts appropriated 

10 under this subsection shall remain available until ex11 pended. 

12 (g) STATE DEFINED.—For purposes of this section, 

13 the term ‘‘State’’ has the meaning given such term for 

14 purposes of title XIX of the Social Security Act. 

15 SEC. 514. GRANT PROGRAM TO FACILITATE HEALTH BENE16 FITS INFORMATION FOR SMALL EMPLOYERS. 

17 (a) IN GENERAL.—The Small Business Administra18 tion shall award grants to 1 or more States, local govern19 ments, and non-profit organizations for the purposes of—

20 (1) demonstrating new and effective ways to 

21 provide information about the benefits of health in22 surance to small employers, including tax benefits, 

23 increased productivity of employees, and decreased 

24 turnover of employees, 
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1 (2) making employers aware of their current 

2 rights in the marketplace under State and Federal 

3 health insurance reforms, and 

4 (3) making employers aware of the tax treat5 ment of insurance premiums. 

6 (b) AUTHORIZATION.—There is authorized to be ap7 propriated $10,000,000 for each of the first 5 fiscal years 

8 beginning after the date of the enactment of this Act for 

9 grants under subsection (a). 

10 SEC. 515. STATE GRANT PROGRAM FOR MARKET INNOVA11 TION. 

12 (a) IN GENERAL.—The Secretary of Health and 

13 Human Services (in this section referred to as the ‘‘Sec14 retary’’) shall establish a program (in this section referred 

15 to as the ‘‘program’’) to award demonstration grants 

16 under this section to States to allow States to demonstrate 

17 the effectiveness of innovative ways to increase access to 

18 health insurance through market reforms and other inno19 vative means. Such innovative means may include (and are 

20 not limited to) any of the following: 

21 (1) Alternative group purchasing or pooling ar22 rangements, such as purchasing cooperatives for 

23 small businesses, reinsurance pools, or high risk 

24 pools. 

25 (2) Individual or small group market reforms. 
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1 (3) Consumer education and outreach. 

2 (4) Subsidies to individuals, employers, or both, 

3 in obtaining health insurance. 

4 (b) SCOPE; DURATION.—The program shall be lim5 ited to not more than 10 States and to a total period of 

6 5 years, beginning on the date the first demonstration 

7 grant is made. 

8 (c) CONDITIONS FOR DEMONSTRATION GRANTS.—

9 (1) IN GENERAL.—The Secretary may not pro10 vide for a demonstration grant to a State under the 

11 program unless the Secretary finds that under the 

12 proposed demonstration grant—

13 (A) the State will provide for demonstrated 

14 increase of access for some portion of the exist15 ing uninsured population through a market in16 novation (other than merely through a financial 

17 expansion of a program initiated before the 

18 date of the enactment of this Act); 

19 (B) the State will comply with applicable 

20 Federal laws; 

21 (C) the State will not discriminate among 

22 participants on the basis of any health status23 related factor (as defined in section 2791(d)(9) 

24 of the Public Health Service Act), except to the 

25 extent a State wishes to focus on populations 
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1 that otherwise would not obtain health insur2 ance because of such factors; and 

3 (D) the State will provide for such evalua4 tion, in coordination with the evaluation re5 quired under subsection (d), as the Secretary 

6 may specify. 

7 (2) APPLICATION.—The Secretary shall not 

8 provide a demonstration grant under the program to 

9 a State unless—

10 (A) the State submits to the Secretary 

11 such an application, in such a form and man12 ner, as the Secretary specifies; 

13 (B) the application includes information 

14 regarding how the demonstration grant will ad15 dress issues such as governance, targeted popu16 lation, expected cost, and the continuation after 

17 the completion of the demonstration grant pe18 riod; and 

19 (C) the Secretary determines that the dem20 onstration grant will be used consistent with 

21 this section. 

22 (3) FOCUS.—A demonstration grant proposal 

23 under section need not cover all uninsured individ24 uals in a State or all health care benefits with re25 spect to such individuals. 
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1 (d) EVALUATION.—The Secretary shall enter into a 

2 contract with an appropriate entity outside the Depart3 ment of Health and Human Services to conduct an overall 

4 evaluation of the program at the end of the program pe5 riod. Such evaluation shall include an analysis of improve6 ments in access, costs, quality of care, or choice of cov7 erage, under different demonstration grants. 

8 (e) OPTION TO PROVIDE FOR INITIAL PLANNING

9 GRANTS.—Notwithstanding the previous provisions of this 

10 section, under the program the Secretary may provide for 

11 a portion of the amounts appropriated under subsection 

12 (f) (not to exceed $5,000,000) to be made available to any 

13 State for initial planning grants to permit States to de14 velop demonstration grant proposals under the previous 

15 provisions of this section. 

16 (f) AUTHORIZATION OF APPROPRIATIONS.—There 

17 are authorized to be appropriated $100,000,000 for each 

18 fiscal year to carry out this section. Amounts appropriated 

19 under this subsection shall remain available until ex20 pended. 

21 (g) STATE DEFINED.—For purposes of this section, 

22 the term ‘‘State’’ has the meaning given such term for 

23 purposes of title XIX of the Social Security Act. 
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1 TITLE VI—EFFECTIVE DATES; 

2 COORDINATION IN IMPLE3 MENTATION 

4 SEC. 601. EFFECTIVE DATES. 

5 (a) GROUP HEALTH COVERAGE.—

6 (1) IN GENERAL.—Subject to paragraph (2) 

7 and subsection (d), the amendments made by sec8 tions 201(a), 401, 501, and 502 (and title I insofar 

9 as it relates to such sections) shall apply with re10 spect to group health plans, and health insurance 

11 coverage offered in connection with group health 

12 plans, for plan years beginning on or after October 

13 1, 2005 (in this section referred to as the ‘‘general 

14 effective date’’). 

15 (2) TREATMENT OF COLLECTIVE BARGAINING

16 AGREEMENTS.—In the case of a group health plan 

17 maintained pursuant to one or more collective bar18 gaining agreements between employee representa19 tives and one or more employers ratified before the 

20 date of the enactment of this Act, the amendments 

21 made by sections 201(a), 401, 501, and 502 (and 

22 title I insofar as it relates to such sections) shall not 

23 apply to plan years beginning before the later of—

24 (A) the date on which the last collective 

25 bargaining agreements relating to the plan ter-
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1 minates (excluding any extension thereof agreed 

2 to after the date of the enactment of this Act); 

3 or 

4 (B) the general effective date; 

5 but shall apply not later than 1 year after the gen6 eral effective date. For purposes of subparagraph 

7 (A), any plan amendment made pursuant to a collec8 tive bargaining agreement relating to the plan which 

9 amends the plan solely to conform to any require10 ment added by this Act shall not be treated as a ter11 mination of such collective bargaining agreement. 

12 (b) INDIVIDUAL HEALTH INSURANCE COVERAGE.—

13 Subject to subsection (d), the amendments made by sec14 tion 202 shall apply with respect to individual health in15 surance coverage offered, sold, issued, renewed, in effect, 

16 or operated in the individual market on or after the gen17 eral effective date. 

18 (c) TREATMENT OF RELIGIOUS NONMEDICAL PRO19 VIDERS.—

20 (1) IN GENERAL.—Nothing in this Act (or the 

21 amendments made thereby) shall be construed to—

22 (A) restrict or limit the right of group 

23 health plans, and of health insurance issuers of24 fering health insurance coverage, to include as 

25 providers religious nonmedical providers; 
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1 (B) require such plans or issuers to—

2 (i) utilize medically based eligibility 

3 standards or criteria in deciding provider 

4 status of religious nonmedical providers; 

5 (ii) use medical professionals or cri6 teria to decide patient access to religious 

7 nonmedical providers; 

8 (iii) utilize medical professionals or 

9 criteria in making decisions in internal or 

10 external appeals regarding coverage for 

11 care by religious nonmedical providers; or 

12 (iv) compel a participant or bene13 ficiary to undergo a medical examination 

14 or test as a condition of receiving health 

15 insurance coverage for treatment by a reli16 gious nonmedical provider; or 

17 (C) require such plans or issuers to ex18 clude religious nonmedical providers because 

19 they do not provide medical or other required 

20 data, if such data is inconsistent with the reli21 gious nonmedical treatment or nursing care 

22 provided by the provider. 

23 (2) RELIGIOUS NONMEDICAL PROVIDER.—For 

24 purposes of this subsection, the term ‘‘religious non25 medical provider’’ means a provider who provides no 
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1 medical care but who provides only religious non2 medical treatment or religious nonmedical nursing 

3 care. 

4 (d) TRANSITION FOR NOTICE REQUIREMENT.—The 

5 disclosure of information required under section 121 of 

6 this Act shall first be provided pursuant to—

7 (1) subsection (a) with respect to a group 

8 health plan that is maintained as of the general ef9 fective date, not later than 30 days before the begin10 ning of the first plan year to which title I applies 

11 in connection with the plan under such subsection; 

12 or 

13 (2) subsection (b) with respect to an individual 

14 health insurance coverage that is in effect as of the 

15 general effective date, not later than 30 days before 

16 the first date as of which title I applies to the cov17 erage under such subsection. 

18 SEC. 602. COORDINATION IN IMPLEMENTATION. 

19 The Secretary of Labor and the Secretary of Health 

20 and Human Services shall ensure, through the execution 

21 of an interagency memorandum of understanding among 

22 such Secretaries, that—

23 (1) regulations, rulings, and interpretations 

24 issued by such Secretaries relating to the same mat25 ter over which such Secretaries have responsibility 
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1 under the provisions of this Act (and the amend2 ments made thereby) are administered so as to have 

3 the same effect at all times; and 

4 (2) coordination of policies relating to enforcing 

5 the same requirements through such Secretaries in 

6 order to have a coordinated enforcement strategy 

7 that avoids duplication of enforcement efforts and 

8 assigns priorities in enforcement. 

9 SEC. 603. SEVERABILITY. 

10 If any provision of this Act, an amendment made by 

11 this Act, or the application of such provision or amend12 ment to any person or circumstance is held to be unconsti13 tutional, the remainder of this Act, the amendments made 

14 by this Act, and the application of the provisions of such 

15 to any person or circumstance shall not be affected there16 by. 

17 TITLE VII—MISCELLANEOUS 

18 PROVISIONS 

19 SEC. 701. NO IMPACT ON SOCIAL SECURITY TRUST FUND. 

20 (a) IN GENERAL.—Nothing in this Act (or an amend21 ment made by this Act) shall be construed to alter or 

22 amend the Social Security Act (or any regulation promul23 gated under that Act). 

24 (b) TRANSFERS.—
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1 (1) ESTIMATE OF SECRETARY.—The Secretary 

2 of the Treasury shall annually estimate the impact 

3 that the enactment of this Act has on the income 

4 and balances of the trust funds established under 

5 section 201 of the Social Security Act (42 U.S.C. 

6 401). 

7 (2) TRANSFER OF FUNDS.—If, under para8 graph (1), the Secretary of the Treasury estimates 

9 that the enactment of this Act has a negative impact 

10 on the income and balances of the trust funds estab11 lished under section 201 of the Social Security Act 

12 (42 U.S.C. 401), the Secretary shall transfer, not 

13 less frequently than quarterly, from the general reve14 nues of the Federal Government an amount suffi15 cient so as to ensure that the income and balances 

16 of such trust funds are not reduced as a result of 

17 the enactment of such Act.

Æ