I 

109TH CONGRESS 

1ST SESSION H. R. 2650 

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 

MAY 26, 2005 

Mr. NORWOOD 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 

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 ‘‘Patient Protection Act of 2005’’. 
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1 (b) TABLE OF CONTENTS.—The table of contents of 

2 this Act is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—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. 

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. 
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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. Cooperation between Federal and State authorities. 

Sec. 403. Sense of the Congress concerning the importance of certain unpaid 

services. 

TITLE V—AMENDMENTS TO THE INTERNAL REVENUE CODE OF 

1986 

Sec. 501. Application of requirements to group health plans under the Internal 

Revenue Code of 1986. 

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

TITLE VI—EFFECTIVE DATES; COORDINATION IN 

IMPLEMENTATION 

Sec. 601. Effective dates. 

Sec. 602. Coordination in implementation. 

Sec. 603. Severability. 

TITLE VII—MISCELLANEOUS PROVISIONS 

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

Sec. 702. Sense of Congress with respect to participation in clinical trials and 

access to specialty care. 

Sec. 703. Sense of the Congress regarding fair review process. 

Sec. 704. Annual review. 
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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. 

23 (3) UTILIZATION REVIEW DEFINED.—For pur24 poses of this section, the terms ‘‘utilization review’’ 

25 and ‘‘utilization review activities’’ mean procedures 
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1 used to monitor or evaluate the use or coverage, 

2 clinical necessity, appropriateness, efficacy, or effi3 ciency of health care services, procedures or settings, 

4 and includes prospective review, concurrent review, 

5 second opinions, case management, discharge plan6 ning, or retrospective review. 

7 (b) WRITTEN POLICIES AND CRITERIA.— 

8 (1) WRITTEN POLICIES.—A utilization review 

9 program shall be conducted consistent with written 

10 policies and procedures that govern all aspects of the 

11 program. 

12 (2) USE OF WRITTEN CRITERIA.— 

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

14 utilize written clinical review criteria developed 

15 with input from a range of appropriate actively 

16 practicing health care professionals, as deter17 mined by the plan, pursuant to the program. 

18 Such criteria shall include written clinical re19 view criteria that are based on valid clinical evi20 dence where available and that are directed spe21 cifically at meeting the needs of at-risk popu22 lations and covered individuals with chronic 

23 conditions or severe illnesses, including gender24 specific criteria and pediatric-specific criteria 

25 where available and appropriate. 
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1 (B) CONTINUING USE OF STANDARDS IN

2 RETROSPECTIVE REVIEW.—If a health care 

3 service has been specifically pre-authorized or 

4 approved for a participant, beneficiary, or en5 rollee under such a program, the program shall 

6 not, pursuant to retrospective review, revise or 

7 modify the specific standards, criteria, or proce8 dures used for the utilization review for proce9 dures, treatment, and services delivered to the 

10 enrollee during the same course of treatment. 

11 (C) REVIEW OF SAMPLE OF CLAIMS DENI12 ALS.—Such a program shall provide for a peri13 odic evaluation of the clinical appropriateness of 

14 at least a sample of denials of claims for bene15 fits. 

16 (c) CONDUCT OF PROGRAM ACTIVITIES.— 

17 (1) ADMINISTRATION BY HEALTH CARE PRO18 FESSIONALS.—A utilization review program shall be 

19 administered by qualified health care professionals 

20 who shall oversee review decisions. 

21 (2) USE OF QUALIFIED, INDEPENDENT PER22 SONNEL.— 

23 (A) IN GENERAL.—A utilization review 

24 program shall provide for the conduct of utiliza25 tion review activities only through personnel 
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1 who are qualified and have received appropriate 

2 training in the conduct of such activities under 

3 the program. 

4 (B) PROHIBITION OF CONTINGENT COM5 PENSATION ARRANGEMENTS.—Such a program 

6 shall not, with respect to utilization review ac7 tivities, permit or provide compensation or any8 thing of value to its employees, agents, or con9 tractors in a manner that encourages denials of 

10 claims for benefits. 

11 (C) PROHIBITION OF CONFLICTS.—Such a 

12 program shall not permit a health care profes13 sional who is providing health care services to 

14 an individual to perform utilization review ac15 tivities in connection with the health care serv16 ices being provided to the individual. 

17 (3) ACCESSIBILITY OF REVIEW.—Such a pro18 gram shall provide that appropriate personnel per19 forming utilization review activities under the pro20 gram, including the utilization review administrator, 

21 are reasonably accessible by toll-free telephone dur22 ing normal business hours to discuss patient care 

23 and allow response to telephone requests, and that 

24 appropriate provision is made to receive and respond 

25 promptly to calls received during other hours. 
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1 (4) LIMITS ON FREQUENCY.—Such a program 

2 shall not provide for the performance of utilization 

3 review activities with respect to a class of services 

4 furnished to an individual more frequently than is 

5 reasonably required to assess whether the services 

6 under review are medically necessary and appro7 priate. 

8 SEC. 102. PROCEDURES FOR INITIAL CLAIMS FOR BENE9 FITS AND PRIOR AUTHORIZATION DETER10 MINATIONS. 

11 (a) PROCEDURES OF INITIAL CLAIMS FOR BENE12 FITS.— 

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

14 health insurance issuer offering health insurance 

15 coverage, shall— 

16 (A) make a determination on an initial 

17 claim for benefits by a participant, beneficiary, 

18 or enrollee (or authorized representative) re19 garding payment or coverage for items or serv20 ices under the terms and conditions of the plan 

21 or coverage involved, including any cost-sharing 

22 amount that the participant, beneficiary, or en23 rollee is required to pay with respect to such 

24 claim for benefits; and 
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1 (B) notify a participant, beneficiary, or en2 rollee (or authorized representative) and the 

3 treating health care professional involved re4 garding a determination on an initial claim for 

5 benefits made under the terms and conditions 

6 of the plan or coverage, including any cost-shar7 ing amounts that the participant, beneficiary, 

8 or enrollee may be required to make with re9 spect to such claim for benefits, and of the 

10 right of the participant, beneficiary, or enrollee 

11 to an internal appeal under section 103. 

12 (2) ACCESS TO INFORMATION.— 

13 (A) TIMELY PROVISION OF NECESSARY IN14 FORMATION.—With respect to an initial claim 

15 for benefits, the participant, beneficiary, or en16 rollee (or authorized representative) and the 

17 treating health care professional (if any) shall 

18 provide the plan or issuer with access to infor19 mation requested by the plan or issuer that is 

20 necessary to make a determination relating to 

21 the claim. Such access shall be provided not 

22 later than 5 days after the date on which the 

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

24 described in subparagraph (B) or (C) of sub25 section (b)(1), by such earlier time as may be 
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1 necessary to comply with the applicable timeline 

2 under such subparagraph. 

3 (B) LIMITED EFFECT OF FAILURE ON

4 PLAN OR ISSUER’S OBLIGATIONS.—Failure of 

5 the participant, beneficiary, or enrollee to com6 ply with the requirements of subparagraph (A) 

7 shall not remove the obligation of the plan or 

8 issuer to make a decision in accordance with 

9 the medical exigencies of the case and as soon 

10 as possible, based on the available information, 

11 and failure to comply with the time limit estab12 lished by this paragraph shall not remove the 

13 obligation of the plan or issuer to comply with 

14 the requirements of this section. 

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

16 for benefits involving an expedited or concurrent de17 termination, a participant, beneficiary, or enrollee 

18 (or authorized representative) may make an initial 

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

20 health insurance issuer offering health insurance 

21 coverage, may require that the participant, bene22 ficiary, or enrollee (or authorized representative) 

23 provide written confirmation of such request in a 

24 timely manner on a form provided by the plan or 

25 issuer. In the case of such an oral request for bene-
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1 fits, the making of the request (and the timing of 

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

3 time of a claim for such benefits without regard to 

4 whether and when a written confirmation of such re5 quest is made. 

6 (b) TIMELINE FOR MAKING DETERMINATIONS.— 

7 (1) PRIOR AUTHORIZATION DETERMINATION.— 

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

9 and a health insurance issuer offering health in10 surance coverage, shall make a prior authoriza11 tion determination on a claim for benefits 

12 (whether oral or written) in accordance with the 

13 medical exigencies of the case and as soon as 

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

15 the date on which the plan or issuer receives in16 formation that is reasonably necessary to enable 

17 the plan or issuer to make a determination on 

18 the request for prior authorization and in no 

19 case later than 28 days after the date of the 

20 claim for benefits is received. 

21 (B) EXPEDITED DETERMINATION.—Not22 withstanding subparagraph (A), a group health 

23 plan, and a health insurance issuer offering 

24 health insurance coverage, shall expedite a prior 

25 authorization determination on a claim for ben-
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1 efits described in such subparagraph when a re2 quest for such an expedited determination is 

3 made by a participant, beneficiary, or enrollee 

4 (or authorized representative) at any time dur5 ing the process for making a determination and 

6 a health care professional certifies, with the re7 quest, that a determination under the proce8 dures described in subparagraph (A) would seri9 ously jeopardize the life or health of the partici10 pant, beneficiary, or enrollee or the ability of 

11 the participant, beneficiary, or enrollee to main12 tain or regain maximum function. Such deter13 mination shall be made in accordance with the 

14 medical exigencies of the case and as soon as 

15 possible, but in no case later than 72 hours 

16 after the time the request is received by the 

17 plan or issuer under this subparagraph. 

18 (C) ONGOING CARE.— 

19 (i) CONCURRENT REVIEW.— 

20 (I) IN GENERAL.—Subject to 

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

22 review of ongoing care (including hos23 pitalization), which results in a termi24 nation or reduction of such care, the 

25 plan or issuer must provide by tele-
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1 phone and in printed form notice of 

2 the concurrent review determination 

3 to the individual or the individual’s 

4 designee and the individual’s health 

5 care provider in accordance with the 

6 medical exigencies of the case and as 

7 soon as possible, with sufficient time 

8 prior to the termination or reduction 

9 to allow for an appeal under section 

10 103(b)(3) to be completed before the 

11 termination or reduction takes effect. 

12 (II) CONTENTS OF NOTICE.— 

13 Such notice shall include, with respect 

14 to ongoing health care items and serv15 ices, the number of ongoing services 

16 approved, the new total of approved 

17 services, the date of onset of services, 

18 and the next review date, if any, as 

19 well as a statement of the individual’s 

20 rights to further appeal. 

21 (ii) RULE OF CONSTRUCTION.—Clause 

22 (i) shall not be construed as requiring 

23 plans or issuers to provide coverage of care 

24 that would exceed the coverage limitations 

25 for such care. 
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1 (2) RETROSPECTIVE DETERMINATION.—A 

2 group health plan, and a health insurance issuer of3 fering health insurance coverage, shall make a retro4 spective determination on a claim for benefits in ac5 cordance with the medical exigencies of the case and 

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

7 the date on which the plan or issuer receives infor8 mation that is reasonably necessary to enable the 

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

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

11 claim for benefits. 

12 (c) NOTICE OF A DENIAL OF A CLAIM FOR BENE13 FITS.—Written notice of a denial made under an initial 

14 claim for benefits shall be issued to the participant, bene15 ficiary, or enrollee (or authorized representative) and the 

16 treating health care professional in accordance with the 

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

18 in no case later than 2 days after the date of the deter19 mination (or, in the case described in subparagraph (B) 

20 or (C) of subsection (b)(1), within the 72-hour or applica21 ble period referred to in such subparagraph). 

22 (d) REQUIREMENTS OF NOTICE OF DETERMINA23 TIONS.—The written notice of a denial of a claim for bene24 fits determination under subsection (c) shall be provided 

25 in printed form and written in a manner calculated to be 
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1 understood by the participant, beneficiary, or enrollee and 

2 shall include— 

3 (1) the specific reasons for the determination 

4 (including a summary of the clinical or scientific evi5 dence used in making the determination); 

6 (2) the procedures for obtaining additional in7 formation concerning the determination; and 

8 (3) notification of the right to appeal the deter9 mination and instructions on how to initiate an ap10 peal in accordance with section 103. 

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

12 (1) AUTHORIZED REPRESENTATIVE.—The term 

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

14 an individual who is a participant, beneficiary, or en15 rollee, any health care professional or other person 

16 acting on behalf of the individual with the individ17 ual’s consent or without such consent if the indi18 vidual is medically unable to provide such consent. 

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

20 for benefits’’ means any request for coverage (in21 cluding authorization of coverage), for eligibility, or 

22 for payment in whole or in part, for an item or serv23 ice under a group health plan or health insurance 

24 coverage. 
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1 (3) DENIAL OF CLAIM FOR BENEFITS.—The 

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

3 benefits, a denial (in whole or in part) of, or a fail4 ure to act on a timely basis upon, the claim for ben5 efits and includes a failure to provide benefits (in6 cluding items and services) required to be provided 

7 under this title. 

8 (4) TREATING HEALTH CARE PROFESSIONAL.— 

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

10 with respect to services to be provided to a partici11 pant, beneficiary, or enrollee, a health care profes12 sional who is primarily responsible for delivering 

13 those services to the participant, beneficiary, or en14 rollee. 

15 SEC. 103. INTERNAL APPEALS OF CLAIMS DENIALS. 

16 (a) RIGHT TO INTERNAL APPEAL.— 

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

18 enrollee (or authorized representative) may appeal 

19 any denial of a claim for benefits under section 102 

20 under the procedures described in this section. 

21 (2) TIME FOR APPEAL.— 

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

23 and a health insurance issuer offering health in24 surance coverage, shall ensure that a partici25 pant, beneficiary, or enrollee (or authorized rep-
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1 resentative) has a period of not less than 180 

2 days beginning on the date of a denial of a 

3 claim for benefits under section 102 in which to 

4 appeal such denial under this section. 

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

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

7 be deemed to be the date as of which the partic8 ipant, beneficiary, or enrollee knew of the denial 

9 of the claim for benefits. 

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

11 issuer to issue a determination on a claim for bene12 fits under section 102 within the applicable timeline 

13 established for such a determination under such sec14 tion is a denial of a claim for benefits for purposes 

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

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

17 group health plan, or health insurance issuer offer18 ing health insurance coverage, may waive the inter19 nal review process under this section. In such case 

20 the plan or issuer shall provide notice to the partici21 pant, beneficiary, or enrollee (or authorized rep22 resentative) involved, the participant, beneficiary, or 

23 enrollee (or authorized representative) involved shall 

24 be relieved of any obligation to complete the internal 

25 review involved, and may, at the option of such par-
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1 ticipant, beneficiary, enrollee, or representative pro2 ceed directly to seek further appeal through external 

3 review under section 104 or otherwise. 

4 (b) TIMELINES FOR MAKING DETERMINATIONS.— 

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

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

7 that involves an expedited or concurrent determina8 tion, a participant, beneficiary, or enrollee (or au9 thorized representative) may request such appeal 

10 orally. A group health plan, or health insurance 

11 issuer offering health insurance coverage, may re12 quire that the participant, beneficiary, or enrollee 

13 (or authorized representative) provide written con14 firmation of such request in a timely manner on a 

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

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

17 making of the request (and the timing of such re18 quest) shall be treated as the making at that time 

19 of a request for an appeal without regard to whether 

20 and when a written confirmation of such request is 

21 made. 

22 (2) ACCESS TO INFORMATION.— 

23 (A) TIMELY PROVISION OF NECESSARY IN24 FORMATION.—With respect to an appeal of a 

25 denial of a claim for benefits, the participant, 
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1 beneficiary, or enrollee (or authorized represent2 ative) and the treating health care professional 

3 (if any) shall provide the plan or issuer with ac4 cess to information requested by the plan or 

5 issuer that is necessary to make a determina6 tion relating to the appeal. Such access shall be 

7 provided not later than 5 days after the date on 

8 which the request for information is received, 

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

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

11 may be necessary to comply with the applicable 

12 timeline under such subparagraph. 

13 (B) LIMITED EFFECT OF FAILURE ON

14 PLAN OR ISSUER’S OBLIGATIONS.—Failure of 

15 the participant, beneficiary, or enrollee to com16 ply with the requirements of subparagraph (A) 

17 shall not remove the obligation of the plan or 

18 issuer to make a decision in accordance with 

19 the medical exigencies of the case and as soon 

20 as possible, based on the available information, 

21 and failure to comply with the time limit estab22 lished by this paragraph shall not remove the 

23 obligation of the plan or issuer to comply with 

24 the requirements of this section. 
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1 (3) PRIOR AUTHORIZATION DETERMINA2 TIONS.— 

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

4 this paragraph or paragraph (4), a group 

5 health plan, and a health insurance issuer offer6 ing health insurance coverage, shall make a de7 termination on an appeal of a denial of a claim 

8 for benefits under this subsection in accordance 

9 with the medical exigencies of the case and as 

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

11 days from the date on which the plan or issuer 

12 receives information that is reasonably nec13 essary to enable the plan or issuer to make a 

14 determination on the appeal and in no case 

15 later than 28 days after the date the request 

16 for the appeal is received. 

17 (B) EXPEDITED DETERMINATION.—Not18 withstanding subparagraph (A), a group health 

19 plan, and a health insurance issuer offering 

20 health insurance coverage, shall expedite a prior 

21 authorization determination on an appeal of a 

22 denial of a claim for benefits described in sub23 paragraph (A), when a request for such an ex24 pedited determination is made by a participant, 

25 beneficiary, or enrollee (or authorized represent-
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1 ative) at any time during the process for mak2 ing a determination and a health care profes3 sional certifies, with the request, that a deter4 mination under the procedures described in sub5 paragraph (A) would seriously jeopardize the 

6 life or health of the participant, beneficiary, or 

7 enrollee or the ability of the participant, bene8 ficiary, or enrollee to maintain or regain max9 imum function. Such determination shall be 

10 made in accordance with the medical exigencies 

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

12 case later than 72 hours after the time the re13 quest for such appeal is received by the plan or 

14 issuer under this subparagraph. 

15 (C) ONGOING CARE DETERMINATIONS.— 

16 (i) IN GENERAL.—Subject to clause 

17 (ii), in the case of a concurrent review de18 termination described in section 

19 102(b)(1)(C)(i)(I), which results in a ter20 mination or reduction of such care, the 

21 plan or issuer must provide notice of the 

22 determination on the appeal under this 

23 section by telephone and in printed form to 

24 the individual or the individual’s designee 

25 and the individual’s health care provider in 
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1 accordance with the medical exigencies of 

2 the case and as soon as possible, with suf3 ficient time prior to the termination or re4 duction to allow for an external appeal 

5 under section 104 to be completed before 

6 the termination or reduction takes effect. 

7 (ii) RULE OF CONSTRUCTION.—Clause 

8 (i) shall not be construed as requiring 

9 plans or issuers to provide coverage of care 

10 that would exceed the coverage limitations 

11 for such care. 

12 (4) RETROSPECTIVE DETERMINATION.—A 

13 group health plan, and a health insurance issuer of14 fering health insurance coverage, shall make a retro15 spective determination on an appeal of a denial of a 

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

17 the date on which the plan or issuer receives nec18 essary information that is reasonably necessary to 

19 enable the plan or issuer to make a determination on 

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

21 the date the request for the appeal is received. 

22 (c) CONDUCT OF REVIEW.— 

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

24 claim for benefits under this section shall be con-
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1 ducted by an individual with appropriate expertise 

2 who was not involved in the initial determination. 

3 (2) PEER REVIEW OF MEDICAL DECISIONS BY

4 HEALTH CARE PROFESSIONALS.—A review of an ap5 peal of a denial of a claim for benefits that is based 

6 on a lack of medical necessity and appropriateness, 

7 or based on an experimental or investigational treat8 ment, or requires an evaluation of medical facts— 

9 (A) shall be made by a physician 

10 (allopathic or osteopathic); or 

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

12 non-physician health professional, shall be made 

13 by a review panel including at least one prac14 ticing non-physician health professional of the 

15 same or similar specialty; 

16 with appropriate expertise (including, in the case of 

17 a child, appropriate pediatric expertise) and acting 

18 within the appropriate scope of practice within the 

19 State in which the service is provided or rendered, 

20 who was not involved in the initial determination. 

21 (d) NOTICE OF DETERMINATION.— 

22 (1) IN GENERAL.—Written notice of a deter23 mination made under an internal appeal of a denial 

24 of a claim for benefits shall be issued to the partici25 pant, beneficiary, or enrollee (or authorized rep-
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1 resentative) and the treating health care professional 

2 in accordance with the medical exigencies of the case 

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

4 2 days after the date of completion of the review (or, 

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

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

7 period referred to in such subparagraph). 

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

9 plan or issuer under this section shall be treated as 

10 the final determination of the plan or issuer on a de11 nial of a claim for benefits. The failure of a plan or 

12 issuer to issue a determination on an appeal of a de13 nial of a claim for benefits under this section within 

14 the applicable timeline established for such a deter15 mination shall be treated as a final determination on 

16 an appeal of a denial of a claim for benefits for pur17 poses of proceeding to external review under section 

18 104. 

19 (3) REQUIREMENTS OF NOTICE.—With respect 

20 to a determination made under this section, the no21 tice described in paragraph (1) shall be provided in 

22 printed form and written in a manner calculated to 

23 be understood by the participant, beneficiary, or en24 rollee and shall include— 
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1 (A) the specific reasons for the determina2 tion (including a summary of the clinical or sci3 entific evidence used in making the determina4 tion); 

5 (B) the procedures for obtaining additional 

6 information concerning the determination; and 

7 (C) notification of the right to an inde8 pendent external review under section 104 and 

9 instructions on how to initiate such a review. 

10 SEC. 104. INDEPENDENT EXTERNAL APPEALS PROCE11 DURES. 

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

13 plan, and a health insurance issuer offering health insur14 ance coverage, shall provide in accordance with this sec15 tion participants, beneficiaries, and enrollees (or author16 ized representatives) with access to an independent exter17 nal review for any denial of a claim for benefits. 

18 (b) INITIATION OF THE INDEPENDENT EXTERNAL

19 REVIEW PROCESS.— 

20 (1) TIME TO FILE.—A request for an inde21 pendent external review under this section shall be 

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

23 after the date on which the participant, beneficiary, 

24 or enrollee receives notice of the denial under section 

25 103(d) or notice of waiver of internal review under 
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1 section 103(a)(4) or the date on which the plan or 

2 issuer has failed to make a timely decision under 

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

4 beneficiary that it has failed to make a timely deci5 sion and that the beneficiary must file an appeal 

6 with an external review entity within 180 days if the 

7 participant or beneficiary desires to file such an ap8 peal. 

9 (2) FILING OF REQUEST.— 

10 (A) IN GENERAL.—Subject to the suc11 ceeding provisions of this subsection, a group 

12 health plan, or health insurance issuer offering 

13 health insurance coverage, may— 

14 (i) except as provided in subparagraph 

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

16 in writing; 

17 (ii) limit the filing of such a request 

18 to the participant, beneficiary, or enrollee 

19 involved (or an authorized representative); 

20 (iii) except if waived by the plan or 

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

22 access to an independent external review 

23 under this section upon a final determina24 tion of a denial of a claim for benefits 
27 

•HR 2650 IH 

1 under the internal review procedure under 

2 section 103; 

3 (iv) except as provided in subpara4 graph (B)(ii), require payment of a filing 

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

6 not exceed $25; and 

7 (v) require that a request for review 

8 include the consent of the participant, ben9 eficiary, or enrollee (or authorized rep10 resentative) for the release of necessary 

11 medical information or records of the par12 ticipant, beneficiary, or enrollee to the 

13 qualified external review entity only for 

14 purposes of conducting external review ac15 tivities. 

16 (B) REQUIREMENTS AND EXCEPTION RE17 LATING TO GENERAL RULE.— 

18 (i) ORAL REQUESTS PERMITTED IN

19 EXPEDITED OR CONCURRENT CASES.—In 

20 the case of an expedited or concurrent ex21 ternal review as provided for under sub22 section (e), the request for such review 

23 may be made orally. A group health plan, 

24 or health insurance issuer offering health 

25 insurance coverage, may require that the 
28 

•HR 2650 IH 

1 participant, beneficiary, or enrollee (or au2 thorized representative) provide written 

3 confirmation of such request in a timely 

4 manner on a form provided by the plan or 

5 issuer. Such written confirmation shall be 

6 treated as a consent for purposes of sub7 paragraph (A)(v). In the case of such an 

8 oral request for such a review, the making 

9 of the request (and the timing of such re10 quest) shall be treated as the making at 

11 that time of a request for such a review 

12 without regard to whether and when a 

13 written confirmation of such request is 

14 made. 

15 (ii) EXCEPTION TO FILING FEE RE16 QUIREMENT.— 

17 (I) INDIGENCY.—Payment of a 

18 filing fee shall not be required under 

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

20 certification (in a form and manner 

21 specified in guidelines established by 

22 the appropriate Secretary) that the 

23 participant, beneficiary, or enrollee is 

24 indigent (as defined in such guide25 lines). 
29 

•HR 2650 IH 

1 (II) FEE NOT REQUIRED.—Pay2 ment of a filing fee shall not be re3 quired under subparagraph (A)(iv) if 

4 the plan or issuer waives the internal 

5 appeals process under section 

6 103(a)(4). 

7 (III) REFUNDING OF FEE.—The 

8 filing fee paid under subparagraph 

9 (A)(iv) shall be refunded if the deter10 mination under the independent exter11 nal review is to reverse the denial 

12 which is the subject of the review. 

13 (IV) COLLECTION OF FILING

14 FEE.—The failure to pay such a filing 

15 fee shall not prevent the consideration 

16 of a request for review but, subject to 

17 the preceding provisions of this clause, 

18 shall constitute a legal liability to pay. 

19 (c) REFERRAL TO QUALIFIED EXTERNAL REVIEW

20 ENTITY UPON REQUEST.— 

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

22 for independent external review with the group 

23 health plan, or health insurance issuer offering 

24 health insurance coverage, the plan or issuer shall 

25 immediately refer such request, and forward the 
30 

•HR 2650 IH 

1 plan or issuer’s initial decision (including the infor2 mation described in section 103(d)(3)(A)), to a 

3 qualified external review entity selected in accord4 ance with this section. 

5 (2) ACCESS TO PLAN OR ISSUER AND HEALTH

6 PROFESSIONAL INFORMATION.—With respect to an 

7 independent external review conducted under this 

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

9 authorized representative), the plan or issuer, and 

10 the treating health care professional (if any) shall 

11 provide the external review entity with information 

12 that is necessary to conduct a review under this sec13 tion, as determined and requested by the entity. 

14 Such information shall be provided not later than 5 

15 days after the date on which the request for infor16 mation is received, or, in a case described in clause 

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

18 time as may be necessary to comply with the appli19 cable timeline under such clause. 

20 (3) SCREENING OF REQUESTS BY QUALIFIED

21 EXTERNAL REVIEW ENTITIES.— 

22 (A) IN GENERAL.—With respect to a re23 quest referred to a qualified external review en24 tity under paragraph (1) relating to a denial of 

25 a claim for benefits, the entity shall refer such 
31 

•HR 2650 IH 

1 request for the conduct of an independent med2 ical review unless the entity determines that— 

3 (i) any of the conditions described in 

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

5 have not been met; 

6 (ii) the denial of the claim for benefits 

7 does not involve a medically reviewable de8 cision under subsection (d)(2); 

9 (iii) the denial of the claim for bene10 fits relates to a decision regarding whether 

11 an individual is a participant, beneficiary, 

12 or enrollee who is enrolled under the terms 

13 and conditions of the plan or coverage (in14 cluding the applicability of any waiting pe15 riod under the plan or coverage); or 

16 (iv) the denial of the claim for bene17 fits is a decision as to the application of 

18 cost-sharing requirements or the applica19 tion of a specific exclusion or express limi20 tation on the amount, duration, or scope of 

21 coverage of items or services under the 

22 terms and conditions of the plan or cov23 erage unless the decision is a denial de24 scribed in subsection (d)(2). 
32 

•HR 2650 IH 

1 Upon making a determination that any of 

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

3 the request, the entity shall determine that the 

4 denial of a claim for benefits involved is not eli5 gible for independent medical review under sub6 section (d), and shall provide notice in accord7 ance with subparagraph (C). 

8 (B) PROCESS FOR MAKING DETERMINA9 TIONS.— 

10 (i) NO DEFERENCE TO PRIOR DETER11 MINATIONS.—In making determinations 

12 under subparagraph (A), there shall be no 

13 deference given to determinations made by 

14 the plan or issuer or the recommendation 

15 of a treating health care professional (if 

16 any). 

17 (ii) USE OF APPROPRIATE PER18 SONNEL.—A qualified external review enti19 ty shall use appropriately qualified per20 sonnel to make determinations under this 

21 section. 

22 (C) NOTICES AND GENERAL TIMELINES

23 FOR DETERMINATION.— 

24 (i) NOTICE IN CASE OF DENIAL OF

25 REFERRAL.—If the entity under this para-
33 

•HR 2650 IH 

1 graph does not make a referral to an inde2 pendent medical review panel, the entity 

3 shall provide notice to the plan or issuer, 

4 the participant, beneficiary, or enrollee (or 

5 authorized representative) filing the re6 quest, and the treating health care profes7 sional (if any) that the denial is not sub8 ject to independent medical review. Such 

9 notice— 

10 (I) shall be written (and, in addi11 tion, may be provided orally) in a 

12 manner calculated to be understood 

13 by a participant or enrollee; 

14 (II) shall include the reasons for 

15 the determination; 

16 (III) include any relevant terms 

17 and conditions of the plan or cov18 erage; and 

19 (IV) include a description of any 

20 further recourse available to the indi21 vidual. 

22 (ii) GENERAL TIMELINE FOR DETER23 MINATIONS.—Upon receipt of information 

24 under paragraph (2), the qualified external 

25 review entity, and if required the inde-
34 

•HR 2650 IH 

1 pendent medical review panel, shall make a 

2 determination within the overall timeline 

3 that is applicable to the case under review 

4 as described in subsection (e), except that 

5 if the entity determines that a referral to 

6 an independent medical review panel is not 

7 required, the entity shall provide notice of 

8 such determination to the participant, ben9 eficiary, or enrollee (or authorized rep10 resentative) within such timeline and with11 in 2 days of the date of such determina12 tion. 

13 (d) INDEPENDENT MEDICAL REVIEW.— 

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

15 entity determines under subsection (c) that a denial 

16 of a claim for benefits is eligible for independent 

17 medical review, the entity shall refer the denial in18 volved to an independent medical reviewer for the 

19 conduct of an independent medical review under this 

20 subsection. 

21 (2) MEDICALLY REVIEWABLE DECISIONS.—A 

22 denial of a claim for benefits is eligible for inde23 pendent medical review if the benefit for the item or 

24 service for which the claim is made would be a cov25 ered benefit under the terms and conditions of the 
35 

•HR 2650 IH 

1 plan or coverage but for one (or more) of the fol2 lowing determinations: 

3 (A) DENIALS BASED ON MEDICAL NECES4 SITY AND APPROPRIATENESS.—A determination 

5 that the item or service is not covered because 

6 it is not medically necessary and appropriate or 

7 based on the application of substantially equiva8 lent terms. 

9 (B) DENIALS BASED ON EXPERIMENTAL

10 OR INVESTIGATIONAL TREATMENT.—A deter11 mination that the item or service is not covered 

12 because it is experimental or investigational or 

13 based on the application of substantially equiva14 lent terms. 

15 (C) DENIALS OTHERWISE BASED ON AN

16 EVALUATION OF MEDICAL FACTS.—A deter17 mination that the item or service or condition 

18 is not covered based on grounds that require an 

19 evaluation of the medical facts by a health care 

20 professional in the specific case involved to de21 termine the coverage and extent of coverage of 

22 the item or service or condition. 

23 (3) INDEPENDENT MEDICAL REVIEW DETER24 MINATION.— 
36 

•HR 2650 IH 

1 (A) IN GENERAL.—An independent med2 ical review panel under this section shall make 

3 a new independent determination with respect 

4 to whether or not the denial of a claim for a 

5 benefit that is the subject of the review should 

6 be upheld or reversed. 

7 (B) STANDARD FOR DETERMINATION.— 

8 The independent medical review panel’s deter9 mination relating to the medical necessity and 

10 appropriateness, or the experimental or inves11 tigational nature, or the evaluation of the med12 ical facts, of the item, service, or condition in13 volved shall be based on the medical condition 

14 of the participant, beneficiary, or enrollee (in15 cluding the medical records of the participant, 

16 beneficiary, or enrollee) and valid, relevant sci17 entific evidence and clinical evidence, including 

18 peer-reviewed medical literature or findings and 

19 including expert opinion. 

20 (C) NO COVERAGE FOR EXCLUDED BENE21 FITS.—Nothing in this subsection shall be con22 strued to permit an independent medical review 

23 panel to require that a group health plan, or 

24 health insurance issuer offering health insur25 ance coverage, provide coverage for items or 
37 

•HR 2650 IH 

1 services for which benefits are specifically ex2 cluded or expressly limited under the plan or 

3 coverage in the plain language of the plan docu4 ment (and which are disclosed under section 

5 121(b)(1)(C)). Notwithstanding any other pro6 vision of this Act, any exclusion of an exact 

7 medical procedure, any exact time limit on the 

8 duration or frequency of coverage, and any 

9 exact dollar limit on the amount of coverage 

10 that is specifically enumerated and defined (in 

11 the plain language of the plan or coverage docu12 ments) under the plan or coverage offered by a 

13 group health plan or health insurance issuer of14 fering health insurance coverage and that is 

15 disclosed under section 121(b)(1) shall be con16 sidered to govern the scope of the benefits that 

17 may be required: Provided, That the terms and 

18 conditions of the plan or coverage relating to 

19 such an exclusion or limit are in compliance 

20 with the requirements of law. 

21 (D) EVIDENCE AND INFORMATION TO BE

22 USED IN MEDICAL REVIEWS.—In making a de23 termination under this subsection, the inde24 pendent medical review panel shall also consider 
38 

•HR 2650 IH 

1 appropriate and available evidence and informa2 tion, including the following: 

3 (i) The determination made by the 

4 plan or issuer with respect to the claim 

5 upon internal review and the evidence, 

6 guidelines, or rationale used by the plan or 

7 issuer in reaching such determination. 

8 (ii) The recommendation of the treat9 ing health care professional and the evi10 dence, guidelines, and rationale used by 

11 the treating health care professional in 

12 reaching such recommendation. 

13 (iii) Additional relevant evidence or 

14 information obtained by the review panel 

15 or submitted by the plan, issuer, partici16 pant, beneficiary, or enrollee (or an au17 thorized representative), or treating health 

18 care professional. 

19 (iv) The plan or coverage document. 

20 (E) INDEPENDENT DETERMINATION.—In 

21 making determinations under this section, a 

22 qualified external review entity and an inde23 pendent medical review panel shall— 

24 (i) consider the claim under review 

25 without deference to the determinations 
39 

•HR 2650 IH 

1 made by the plan or issuer or the rec2 ommendation of the treating health care 

3 professional (if any); and 

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

5 definition used by the plan or issuer of 

6 ‘‘medically necessary and appropriate’’, or 

7 ‘‘experimental or investigational’’, or other 

8 substantially equivalent terms that are 

9 used by the plan or issuer to describe med10 ical necessity and appropriateness or ex11 perimental or investigational nature of the 

12 treatment. 

13 (F) DETERMINATION OF INDEPENDENT

14 MEDICAL REVIEW PANEL.—An independent 

15 medical review panel shall, in accordance with 

16 the deadlines described in subsection (e), pre17 pare a written determination to uphold or re18 verse the denial under review. Such written de19 termination shall include— 

20 (i) the determination of the review 

21 panel; 

22 (ii) the specific reasons of the review 

23 panel for such determination, including a 

24 summary of the clinical or scientific evi-
40 

•HR 2650 IH 

1 dence used in making the determination; 

2 and 

3 (iii) with respect to a determination to 

4 reverse the denial under review, a time5 frame within which the plan or issuer must 

6 comply with such determination. 

7 (G) NONBINDING NATURE OF ADDITIONAL

8 RECOMMENDATIONS.—In addition to the deter9 mination under subparagraph (F), the review 

10 panel may provide the plan or issuer and the 

11 treating health care professional with additional 

12 recommendations in connection with such a de13 termination, but any such recommendations 

14 shall not affect (or be treated as part of) the 

15 determination and shall not be binding on the 

16 plan or issuer. 

17 (e) TIMELINES AND NOTIFICATIONS.— 

18 (1) TIMELINES FOR INDEPENDENT MEDICAL

19 REVIEW.— 

20 (A) PRIOR AUTHORIZATION DETERMINA21 TION.— 

22 (i) IN GENERAL.—The independent 

23 medical review panel shall make a deter24 mination on a denial of a claim for benefits 

25 that is referred to the review panel under 
41 

•HR 2650 IH 

1 subsection (c)(3) in accordance with the 

2 medical exigencies of the case and as soon 

3 as possible, but in no case later than 14 

4 days after the date of receipt of informa5 tion under subsection (c)(2) if the review 

6 involves a prior authorization of items or 

7 services and in no case later than 21 days 

8 after the date the request for external re9 view is received. 

10 (ii) EXPEDITED DETERMINATION.— 

11 Notwithstanding clause (i) and subject to 

12 clause (iii), the independent medical review 

13 panel shall make an expedited determina14 tion on a denial of a claim for benefits de15 scribed in clause (i), when a request for 

16 such an expedited determination is made 

17 by a participant, beneficiary, or enrollee 

18 (or authorized representative) at any time 

19 during the process for making a deter20 mination, and a health care professional 

21 certifies, with the request, that a deter22 mination under the timeline described in 

23 clause (i) would seriously jeopardize the 

24 life or health of the participant, bene25 ficiary, or enrollee or the ability of the par-
42 

•HR 2650 IH 

1 ticipant, beneficiary, or enrollee to main2 tain or regain maximum function. Such de3 termination shall be made in accordance 

4 with the medical exigencies of the case and 

5 as soon as possible, but in no case later 

6 than 72 hours after the time the request 

7 for external review is received by the quali8 fied external review entity. 

9 (iii) ONGOING CARE DETERMINA10 TION.—Notwithstanding clause (i), in the 

11 case of a review described in such clause 

12 that involves a termination or reduction of 

13 care, the notice of the determination shall 

14 be completed not later than 24 hours after 

15 the time the request for external review is 

16 received by the qualified external review 

17 entity and before the end of the approved 

18 period of care. 

19 (B) RETROSPECTIVE DETERMINATION.— 

20 The independent medical review panel shall 

21 complete a review in the case of a retrospective 

22 determination on an appeal of a denial of a 

23 claim for benefits that is referred to the review 

24 panel under subsection (c)(3) in no case later 

25 than 30 days after the date of receipt of infor-
43 

•HR 2650 IH 

1 mation under subsection (c)(2) and in no case 

2 later than 60 days after the date the request 

3 for external review is received by the qualified 

4 external review entity. 

5 (2) NOTIFICATION OF DETERMINATION.—The 

6 external review entity shall ensure that the plan or 

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

8 authorized representative) and the treating health 

9 care professional (if any) receives a copy of the writ10 ten determination of the independent medical review 

11 panel prepared under subsection (d)(3)(F). Nothing 

12 in this paragraph shall be construed as preventing 

13 an entity or review panel from providing an initial 

14 oral notice of the review panel’s determination. 

15 (3) FORM OF NOTICES.—Determinations and 

16 notices under this subsection shall be written in a 

17 manner calculated to be understood by a participant. 

18 (f) COMPLIANCE.— 

19 (1) APPLICATION OF DETERMINATIONS.— 

20 (A) EXTERNAL REVIEW DETERMINATIONS

21 BINDING ON PLAN.—The determinations of an 

22 external review entity and an independent med23 ical review panel under this section shall be 

24 binding upon the plan or issuer involved. 
44 

•HR 2650 IH 

1 (B) COMPLIANCE WITH DETERMINA2 TION.—If the determination of an independent 

3 medical review panel is to reverse the denial, 

4 the plan or issuer, upon the receipt of such de5 termination, shall authorize coverage to comply 

6 with the medical reviewer’s determination in ac7 cordance with the timeframe established by the 

8 medical review panel. 

9 (2) FAILURE TO COMPLY.— 

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

11 to comply with the timeframe established under 

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

13 beneficiary, or enrollee, where such failure to 

14 comply is caused by the plan or issuer, the par15 ticipant, beneficiary, or enrollee may obtain the 

16 items or services involved (in a manner con17 sistent with the determination of the inde18 pendent external review panel) from any pro19 vider regardless of whether such provider is a 

20 participating provider under the plan or cov21 erage. 

22 (B) REIMBURSEMENT.— 

23 (i) IN GENERAL.—Where a partici24 pant, beneficiary, or enrollee obtains items 

25 or services in accordance with subpara-
45 

•HR 2650 IH 

1 graph (A), the plan or issuer involved shall 

2 provide for reimbursement of the costs of 

3 such items or services. Such reimburse4 ment shall be made to the treating health 

5 care professional or to the participant, ben6 eficiary, or enrollee (in the case of a partic7 ipant, beneficiary, or enrollee who pays for 

8 the costs of such items or services). 

9 (ii) AMOUNT.—The plan or issuer 

10 shall fully reimburse a professional, partici11 pant, beneficiary, or enrollee under clause 

12 (i) for the total costs of the items or serv13 ices provided (regardless of any plan limi14 tations that may apply to the coverage of 

15 such items or services) so long as the items 

16 or services were provided in a manner con17 sistent with the determination of the inde18 pendent medical review panel. 

19 (C) FAILURE TO REIMBURSE.—Where a 

20 plan or issuer fails to provide reimbursement to 

21 a professional, participant, beneficiary, or en22 rollee in accordance with this paragraph, the 

23 professional, participant, beneficiary, or enrollee 

24 may commence a civil action (or utilize other 

25 remedies available under law) to recover only 
46 

•HR 2650 IH 

1 the amount of any such reimbursement that is 

2 owed by the plan or issuer and any necessary 

3 legal costs or expenses (including attorney’s 

4 fees) incurred in recovering such reimburse5 ment. 

6 (D) AVAILABLE REMEDIES.—The remedies 

7 provided under this paragraph are in addition 

8 to any other available remedies. 

9 (3) PENALTIES AGAINST AUTHORIZED OFFI10 CIALS FOR REFUSING TO AUTHORIZE THE DETER11 MINATION OF AN EXTERNAL REVIEW ENTITY.— 

12 (A) MONETARY PENALTIES.— 

13 (i) IN GENERAL.—In any case in 

14 which the determination of an external re15 view entity is not followed by a group 

16 health plan, or by a health insurance issuer 

17 offering health insurance coverage, any 

18 person who, acting in the capacity of au19 thorizing the benefit, causes such refusal 

20 may, in the discretion of a court of com21 petent jurisdiction, be liable to an ag22 grieved participant, beneficiary, or enrollee 

23 for a civil penalty in an amount of up to 

24 $1,000 a day from the date on which the 

25 determination was transmitted to the plan 
47 

•HR 2650 IH 

1 or issuer by the external review entity until 

2 the date the refusal to provide the benefit 

3 is corrected. 

4 (ii) ADDITIONAL PENALTY FOR FAIL5 ING TO FOLLOW TIMELINE.—In any case 

6 in which treatment was not commenced by 

7 the plan in accordance with the determina8 tion of an independent external review 

9 panel, the Secretary shall assess a civil 

10 penalty of $10,000 against the plan and 

11 the plan shall pay such penalty to the par12 ticipant, beneficiary, or enrollee involved. 

13 (B) CEASE AND DESIST ORDER AND

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

15 described in subparagraph (A) brought by a 

16 participant, beneficiary, or enrollee with respect 

17 to a group health plan, or a health insurance 

18 issuer offering health insurance coverage, in 

19 which a plaintiff alleges that a person referred 

20 to in such subparagraph has taken an action re21 sulting in a refusal of a benefit determined by 

22 an external appeal entity to be covered, or has 

23 failed to take an action for which such person 

24 is responsible under the terms and conditions of 

25 the plan or coverage and which is necessary 
48 

•HR 2650 IH 

1 under the plan or coverage for authorizing a 

2 benefit, the court shall cause to be served on 

3 the defendant an order requiring the defend4 ant— 

5 (i) to cease and desist from the al6 leged action or failure to act; and 

7 (ii) to pay to the plaintiff a reasonable 

8 attorney’s fee and other reasonable costs 

9 relating to the prosecution of the action on 

10 the charges on which the plaintiff prevails. 

11 (C) ADDITIONAL CIVIL PENALTIES.— 

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

13 penalty imposed under subparagraph (A) 

14 or (B), the appropriate Secretary may as15 sess a civil penalty against a person acting 

16 in the capacity of authorizing a benefit de17 termined by an external review entity for 

18 one or more group health plans, or health 

19 insurance issuers offering health insurance 

20 coverage, for— 

21 (I) any pattern or practice of re22 peated refusal to authorize a benefit 

23 determined by an external appeal enti24 ty to be covered; or 
49 

•HR 2650 IH 

1 (II) any pattern or practice of re2 peated violations of the requirements 

3 of this section with respect to such 

4 plan or coverage. 

5 (ii) STANDARD OF PROOF AND

6 AMOUNT OF PENALTY.—Such penalty shall 

7 be payable only upon proof by clear and 

8 convincing evidence of such pattern or 

9 practice and shall be in an amount not to 

10 exceed the lesser of— 

11 (I) 25 percent of the aggregate 

12 value of benefits shown by the appro13 priate Secretary to have not been pro14 vided, or unlawfully delayed, in viola15 tion of this section under such pattern 

16 or practice; or 

17 (II) $500,000. 

18 (D) REMOVAL AND DISQUALIFICATION.— 

19 Any person acting in the capacity of author20 izing benefits who has engaged in any such pat21 tern or practice described in subparagraph 

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

23 the petition of the appropriate Secretary, may 

24 be removed by the court from such position, 

25 and from any other involvement, with respect to 
50 

•HR 2650 IH 

1 such a plan or coverage, and may be precluded 

2 from returning to any such position or involve3 ment for a period determined by the court. 

4 (4) PROTECTION OF LEGAL RIGHTS.—Nothing 

5 in this subsection or subtitle shall be construed as 

6 altering or eliminating any cause of action or legal 

7 rights or remedies of participants, beneficiaries, en8 rollees, and others under State or Federal law (in9 cluding sections 502 and 503 of the Employee Re10 tirement Income Security Act of 1974), including 

11 the right to file judicial actions to enforce rights. 

12 (g) QUALIFICATIONS OF INDEPENDENT MEDICAL

13 REVIEWERS.— 

14 (1) IN GENERAL.—In referring a denial to an 

15 independent medical review panel to conduct inde16 pendent medical review under subsection (c), the 

17 qualified external review entity shall ensure that— 

18 (A) each independent medical reviewer 

19 meets the qualifications described in paragraphs 

20 (2) and (3); 

21 (B) with respect to each review, the review 

22 panel meets the requirements of paragraph (4) 

23 and at least 1 reviewer on the panel meets the 

24 requirements described in paragraph (5); and 
51 

•HR 2650 IH 

1 (C) compensation provided by the entity to 

2 each 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). 
52 

•HR 2650 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 
53 

•HR 2650 IH 

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, the independent medical re-
54 

•HR 2650 IH 

1 view panel shall include at least one prac2 ticing non-physician health care profes3 sional of the same or similar specialty as 

4 the non-physician health care professional 

5 who, acting within the appropriate scope of 

6 practice within the State in which the serv7 ice is provided or rendered, typically treats 

8 the condition, makes the diagnosis, or pro9 vides the type 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 review panel. 

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 review panels it 

17 refers cases to). 

18 (III) Compliance with limitations 

19 on compensation (with respect to both 

20 the entity and independent medical re21 view panels 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 review panels may not require 

6 coverage for specifically excluded ben7 efits. 

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 an independent medical re19 view panel and the reasons for such 

20 dispositions (including the application 

21 of 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 review panel), shall be held 

18 by 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 review panels 

10 and the number of denials that have been re11 versed by such panels; and 

12 (C) the extent to which independent med13 ical review panels are requiring coverage for 

14 benefits that are specifically excluded under the 

15 plan 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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•HR 2650 IH 

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 
74 

•HR 2650 IH 

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 specialists). 

4 SEC. 113. ACCESS TO EMERGENCY CARE. 

5 (a) COVERAGE OF EMERGENCY SERVICES.— 

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

7 health insurance coverage offered by a health insur8 ance issuer, provides or covers any benefits with re9 spect to services in an emergency department of a 

10 hospital, the plan or issuer shall cover emergency 

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

12 (A) without the need for any prior author13 ization determination; 

14 (B) whether the health care provider fur15 nishing such services is a participating provider 

16 with respect to such services; 

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

18 are provided to a participant, beneficiary, or en19 rollee— 

20 (i) by a nonparticipating health care 

21 provider with or without prior authoriza22 tion, or 

23 (ii) by a participating health care pro24 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 (e) 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 prescription 

19 drugs under section 118 if such section applies. 

20 (12) EMERGENCY SERVICES.—A summary of 

21 the rules and procedures for accessing emergency 

22 services, including the right of a participant, bene23 ficiary, or enrollee to obtain emergency services 

24 under the prudent layperson standard under section 

25 113, if such section applies, and any educational in-
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1 formation that the plan or issuer may provide re2 garding the appropriate use of emergency services. 

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

4 the plan or issuer’s rules and procedures pertaining 

5 to claims and appeals, a description of the rights 

6 (including deadlines for exercising rights) of partici7 pants, beneficiaries, and enrollees under subtitle A 

8 in obtaining covered benefits, filing a claim for bene9 fits, and appealing coverage decisions internally and 

10 externally (including telephone numbers and mailing 

11 addresses of the appropriate authority), and a de12 scription of any additional legal rights and remedies 

13 available under section 502 of the Employee Retire14 ment Income Security Act of 1974 and applicable 

15 State law. 

16 (14) ADVANCE DIRECTIVES AND ORGAN DONA17 TION.—A description of procedures for advance di18 rectives and organ donation decisions if the plan or 

19 issuer maintains such procedures. 

20 (15) INFORMATION ON PLANS AND ISSUERS.— 

21 The name, mailing address, and telephone number 

22 or numbers of the plan administrator and the issuer 

23 to be used by participants, beneficiaries, and enroll24 ees seeking information about plan or coverage bene25 fits and services, payment of a claim, or authoriza-
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1 tion for services and treatment. Notice of whether 

2 the benefits under the plan or coverage are provided 

3 under a contract or policy of insurance issued by an 

4 issuer, or whether benefits are provided directly by 

5 the plan sponsor who bears the insurance risk. 

6 (16) TRANSLATION SERVICES.—A summary de7 scription of any translation or interpretation services 

8 (including the availability of printed information in 

9 languages other than English, audio tapes, or infor10 mation in Braille) that are available for non-English 

11 speakers and participants, beneficiaries, and enroll12 ees with communication disabilities and a description 

13 of how to access these items or services. 

14 (17) ACCREDITATION INFORMATION.—Any in15 formation that is made public by accrediting organi16 zations in the process of accreditation if the plan or 

17 issuer is accredited, or any additional quality indica18 tors (such as the results of enrollee satisfaction sur19 veys) that the plan or issuer makes public or makes 

20 available to participants, beneficiaries, and enrollees. 

21 (18) NOTICE OF REQUIREMENTS.—A descrip22 tion of any rights of participants, beneficiaries, and 

23 enrollees that are established by the provisions of 

24 this Act (excluding those described in paragraphs 

25 (1) through (17)) if such provisions apply. The de-
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1 scription required under this paragraph may be com2 bined with the notices of the type described in sec3 tions 711(d), 713(b), or 606(a)(1) of the Employee 

4 Retirement Income Security Act of 1974 and with 

5 any other notice provision that the appropriate Sec6 retary determines may be combined, so long as such 

7 combination does not result in any reduction in the 

8 information that would otherwise be provided to the 

9 recipient. 

10 (19) AVAILABILITY OF ADDITIONAL INFORMA11 TION.—A statement that the information described 

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

13 information (including telephone numbers and, if 

14 available, Internet websites), shall be made available 

15 upon request. 

16 (20) DESIGNATED DECISIONMAKERS.—A de17 scription of the participants and beneficiaries with 

18 respect to whom each designated decisionmaker 

19 under the plan has assumed liability under section 

20 502(o) of the Employee Retirement Income Security 

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

22 decisionmaker. 

23 (c) ADDITIONAL INFORMATION.—The informational 

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

25 beneficiary, or enrollee shall include for each option avail-
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1 able under a group health plan or health insurance cov2 erage the following: 

3 (1) STATUS OF PROVIDERS.—The State licen4 sure status of the plan or issuer’s participating 

5 health care professionals and participating health 

6 care facilities, and, if available, the education, train7 ing, specialty qualifications or certifications of such 

8 professionals. 

9 (2) COMPENSATION METHODS.—A summary 

10 description by category of the applicable methods 

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

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

13 for compensating prospective or treating health care 

14 professionals (including primary care providers and 

15 specialists) and facilities in connection with the pro16 vision of health care under the plan or coverage. 

17 (3) PRESCRIPTION DRUGS.—Information about 

18 whether a specific prescription medication is in19 cluded in the formulary of the plan or issuer, if the 

20 plan or issuer uses a defined formulary. 

21 (4) UTILIZATION REVIEW ACTIVITIES.—A de22 scription of procedures used and requirements (in23 cluding circumstances, timeframes, and appeals 

24 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 or MedicareAdvantage organization, or an individual en14 rolled with such an organization shall be treated as a ref15 erence to the applicable authority, a group health plan or 

16 health insurance issuer, respectively, and a participant, 

17 beneficiary, or enrollee with the plan or organization, re18 spectively. 

19 (c) CONSTRUCTION.—Nothing in this section shall be 

20 construed as prohibiting all capitation and similar ar21 rangements or all provider discount arrangements. 

22 SEC. 134. PAYMENT OF CLAIMS. 

23 A group health plan, and a health insurance issuer 

24 offering health insurance coverage, shall provide for 

25 prompt payment of claims submitted for health care serv26 ices or supplies furnished to a participant, beneficiary, or 
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1 enrollee with respect to benefits covered by the plan or 

2 issuer, in a manner that is no less protective than the pro3 visions of section 1842(c)(2) of the Social Security Act 

4 (42 U.S.C. 1395u(c)(2)). 

5 SEC. 135. PROTECTION FOR PATIENT ADVOCACY. 

6 (a) PROTECTION FOR USE OF UTILIZATION REVIEW

7 AND GRIEVANCE PROCESS.—A group health plan, and a 

8 health insurance issuer with respect to the provision of 

9 health insurance coverage, may not retaliate against a par10 ticipant, beneficiary, enrollee, or health care provider 

11 based on the participant’s, beneficiary’s, enrollee’s or pro12 vider’s use of, or participation in, a utilization review proc13 ess or a grievance process of the plan or issuer (including 

14 an internal or external review or appeal process) under 

15 this title. 

16 (b) PROTECTION FOR QUALITY ADVOCACY BY

17 HEALTH CARE PROFESSIONALS.— 

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

19 health insurance issuer may not retaliate or dis20 criminate against a protected health care profes21 sional because the professional in good faith— 

22 (A) discloses information relating to the 

23 care, services, or conditions affecting one or 

24 more participants, beneficiaries, or enrollees of 

25 the plan or issuer to an appropriate public reg-
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1 ulatory agency, an appropriate private accredi2 tation body, or appropriate management per3 sonnel of the plan or issuer; or 

4 (B) initiates, cooperates, or otherwise par5 ticipates in an investigation or proceeding by 

6 such an agency with respect to such care, serv7 ices, or conditions. 

8 If an institutional health care provider is a partici9 pating provider with such a plan or issuer or other10 wise receives payments for benefits provided by such 

11 a plan or issuer, the provisions of the previous sen12 tence shall apply to the provider in relation to care, 

13 services, or conditions affecting one or more patients 

14 within an institutional health care provider in the 

15 same manner as they apply to the plan or issuer in 

16 relation to care, services, or conditions provided to 

17 one or more participants, beneficiaries, or enrollees; 

18 and for purposes of applying this sentence, any ref19 erence to a plan or issuer is deemed a reference to 

20 the institutional health care provider. 

21 (2) GOOD FAITH ACTION.—For purposes of 

22 paragraph (1), a protected health care professional 

23 is considered to be acting in good faith with respect 

24 to disclosure of information or participation if, with 
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1 respect to the information disclosed as part of the 

2 action— 

3 (A) the disclosure is made on the basis of 

4 personal knowledge and is consistent with that 

5 degree of learning and skill ordinarily possessed 

6 by health care professionals with the same li7 censure or certification and the same experi8 ence; 

9 (B) the professional reasonably believes the 

10 information to be true; 

11 (C) the information evidences either a vio12 lation of a law, rule, or regulation, of an appli13 cable accreditation standard, or of a generally 

14 recognized professional or clinical standard or 

15 that a patient is in imminent hazard of loss of 

16 life or serious injury; and 

17 (D) subject to subparagraphs (B) and (C) 

18 of paragraph (3), the professional has followed 

19 reasonable internal procedures of the plan, 

20 issuer, or institutional health care provider es21 tablished for the purpose of addressing quality 

22 concerns before making the disclosure. 

23 (3) EXCEPTION AND SPECIAL RULE.— 

24 (A) GENERAL EXCEPTION.—Paragraph (1) 

25 does not protect disclosures that would violate 
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1 Federal or State law or diminish or impair the 

2 rights of any person to the continued protection 

3 of confidentiality of communications provided 

4 by such law. 

5 (B) NOTICE OF INTERNAL PROCEDURES.— 

6 Subparagraph (D) of paragraph (2) shall not 

7 apply unless the internal procedures involved 

8 are reasonably expected to be known to the 

9 health care professional involved. For purposes 

10 of this subparagraph, a health care professional 

11 is reasonably expected to know of internal pro12 cedures if those procedures have been made 

13 available to the professional through distribu14 tion or posting. 

15 (C) INTERNAL PROCEDURE EXCEPTION.— 

16 Subparagraph (D) of paragraph (2) also shall 

17 not apply if— 

18 (i) the disclosure relates to an immi19 nent hazard of loss of life or serious injury 

20 to a patient; 

21 (ii) the disclosure is made to an ap22 propriate private accreditation body pursu23 ant to disclosure procedures established by 

24 the body; or 
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1 (iii) the disclosure is in response to an 

2 inquiry made in an investigation or pro3 ceeding of an appropriate public regulatory 

4 agency and the information disclosed is 

5 limited to the scope of the investigation or 

6 proceeding. 

7 (4) ADDITIONAL CONSIDERATIONS.—It shall 

8 not be a violation of paragraph (1) to take an ad9 verse action against a protected health care profes10 sional if the plan, issuer, or provider taking the ad11 verse action involved demonstrates that it would 

12 have taken the same adverse action even in the ab13 sence of the activities protected under such para14 graph. 

15 (5) NOTICE.—A group health plan, health in16 surance issuer, and institutional health care provider 

17 shall post a notice, to be provided or approved by 

18 the Secretary of Labor, setting forth excerpts from, 

19 or summaries of, the pertinent provisions of this 

20 subsection and information pertaining to enforce21 ment of such provisions. 

22 (6) CONSTRUCTIONS.— 

23 (A) DETERMINATIONS OF COVERAGE.— 

24 Nothing in this subsection shall be construed to 

25 prohibit a plan or issuer from making a deter-
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1 mination not to pay for a particular medical 

2 treatment or service or the services of a type of 

3 health care professional. 

4 (B) ENFORCEMENT OF PEER REVIEW PRO5 TOCOLS AND INTERNAL PROCEDURES.—Noth6 ing in this subsection shall be construed to pro7 hibit a plan, issuer, or provider from estab8 lishing and enforcing reasonable peer review or 

9 utilization review protocols or determining 

10 whether a protected health care professional has 

11 complied with those protocols or from estab12 lishing and enforcing internal procedures for 

13 the purpose of addressing quality concerns. 

14 (C) RELATION TO OTHER RIGHTS.—Noth15 ing in this subsection shall be construed to 

16 abridge rights of participants, beneficiaries, en17 rollees, and protected health care professionals 

18 under other applicable Federal or State laws. 

19 (7) PROTECTED HEALTH CARE PROFESSIONAL

20 DEFINED.—For purposes of this subsection, the 

21 term ‘‘protected health care professional’’ means an 

22 individual who is a licensed or certified health care 

23 professional and who— 

24 (A) with respect to a group health plan or 

25 health insurance issuer, is an employee of the 
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1 plan or issuer or has a contract with the plan 

2 or issuer for provision of services for which ben3 efits are available under the plan or issuer; or 

4 (B) with respect to an institutional health 

5 care provider, is an employee of the provider or 

6 has a contract or other arrangement with the 

7 provider respecting the provision of health care 

8 services. 

9 Subtitle E—Definitions 

10 SEC. 151. DEFINITIONS. 

11 (a) INCORPORATION OF GENERAL DEFINITIONS.— 

12 Except as otherwise provided, the provisions of section 

13 2791 of the Public Health Service Act shall apply for pur14 poses of this title in the same manner as they apply for 

15 purposes of title XXVII of such Act. 

16 (b) SECRETARY.—Except as otherwise provided, the 

17 term ‘‘Secretary’’ means the Secretary of Health and 

18 Human Services, in consultation with the Secretary of 

19 Labor and the term ‘‘appropriate Secretary’’ means the 

20 Secretary of Health and Human Services in relation to 

21 carrying out this title under sections 2706 and 2751 of 

22 the Public Health Service Act and the Secretary of Labor 

23 in relation to carrying out this title under section 714 of 

24 the Employee Retirement Income Security Act of 1974. 
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1 (c) ADDITIONAL DEFINITIONS.—For purposes of this 

2 title: 

3 (1) APPLICABLE AUTHORITY.—The term ‘‘ap4 plicable authority’’ means— 

5 (A) in the case of a group health plan, the 

6 Secretary of Health and Human Services and 

7 the Secretary of Labor; and 

8 (B) in the case of a health insurance issuer 

9 with respect to a specific provision of this title, 

10 the applicable State authority (as defined in 

11 section 2791(d) of the Public Health Service 

12 Act), or the Secretary of Health and Human 

13 Services, if such Secretary is enforcing such 

14 provision under section 2722(a)(2) or 

15 2761(a)(2) of the Public Health Service Act. 

16 (2) ENROLLEE.—The term ‘‘enrollee’’ means, 

17 with respect to health insurance coverage offered by 

18 a health insurance issuer, an individual enrolled with 

19 the issuer to receive such coverage. 

20 (3) GROUP HEALTH PLAN.—The term ‘‘group 

21 health plan’’ has the meaning given such term in 

22 section 733(a) of the Employee Retirement Income 

23 Security Act of 1974, except that such term includes 

24 an employee welfare benefit plan treated as a group 

25 health plan under section 732(d) of such Act or de-
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1 fined as such a plan under section 607(1) of such 

2 Act. 

3 (4) HEALTH CARE PROFESSIONAL.—The term 

4 ‘‘health care professional’’ means an individual who 

5 is licensed, accredited, or certified under State law 

6 to provide specified health care services and who is 

7 operating within the scope of such licensure, accredi8 tation, or certification. 

9 (5) HEALTH CARE PROVIDER.—The term 

10 ‘‘health care provider’’ includes a physician or other 

11 health care professional, as well as an institutional 

12 or other facility or agency that provides health care 

13 services and that is licensed, accredited, or certified 

14 to provide health care items and services under ap15 plicable State law. 

16 (6) NETWORK.—The term ‘‘network’’ means, 

17 with respect to a group health plan or health insur18 ance issuer offering health insurance coverage, the 

19 participating health care professionals and providers 

20 through whom the plan or issuer provides health 

21 care items and services to participants, beneficiaries, 

22 or enrollees. 

23 (7) NONPARTICIPATING.—The term ‘‘non24 participating’’ means, with respect to a health care 

25 provider that provides health care items and services 
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1 to a participant, beneficiary, or enrollee under group 

2 health plan or health insurance coverage, a health 

3 care provider that is not a participating health care 

4 provider with respect to such items and services. 

5 (8) PARTICIPATING.—The term ‘‘participating’’ 

6 means, with respect to a health care provider that 

7 provides health care items and services to a partici8 pant, beneficiary, or enrollee under group health 

9 plan or health insurance coverage offered by a 

10 health insurance issuer, a health care provider that 

11 furnishes such items and services under a contract 

12 or other arrangement with the plan or issuer. 

13 (9) PRIOR AUTHORIZATION.—The term ‘‘prior 

14 authorization’’ means the process of obtaining prior 

15 approval from a health insurance issuer or group 

16 health plan for the provision or coverage of medical 

17 services. 

18 (10) TERMS AND CONDITIONS.—The term 

19 ‘‘terms and conditions’’ includes, with respect to a 

20 group health plan or health insurance coverage, re21 quirements imposed under this title with respect to 

22 the plan or coverage. 
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1 SEC. 152. PREEMPTION; STATE FLEXIBILITY; CONSTRUC2 TION. 

3 (a) CONTINUED APPLICABILITY OF STATE LAW

4 WITH RESPECT TO HEALTH INSURANCE ISSUERS.— 

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

6 this title shall not be construed to supersede any 

7 provision of State law which establishes, implements, 

8 or continues in effect any standard or requirement 

9 solely relating to health insurance issuers (in connec10 tion with group health insurance coverage or other11 wise) except to the extent that such standard or re12 quirement prevents the application of a requirement 

13 of this title. 

14 (2) CONTINUED PREEMPTION WITH RESPECT

15 TO GROUP HEALTH PLANS.—Nothing in this title 

16 shall be construed to affect or modify the provisions 

17 of section 514 of the Employee Retirement Income 

18 Security Act of 1974 with respect to group health 

19 plans. 

20 (3) CONSTRUCTION.—In applying this section, 

21 a State law that provides for equal access to, and 

22 availability of, all categories of licensed health care 

23 providers and services shall not be treated as pre24 venting the application of any requirement of this 

25 title. 
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1 (b) APPLICATION OF SUBSTANTIALLY COMPLIANT

2 STATE LAWS.— 

3 (1) IN GENERAL.—In the case of a State law 

4 that imposes, with respect to health insurance cov5 erage offered by a health insurance issuer and with 

6 respect to a group health plan that is a non-Federal 

7 governmental plan, a requirement that substantially 

8 complies (within the meaning of subsection (c)) with 

9 a patient protection requirement (as defined in para10 graph (3)) and does not prevent the application of 

11 other requirements under this Act (except in the 

12 case of other substantially compliant requirements), 

13 in applying the requirements of this title under sec14 tion 2707 and 2753 (as applicable) of the Public 

15 Health Service Act (as added by title II), subject to 

16 subsection (a)(2)— 

17 (A) the State law shall not be treated as 

18 being superseded under subsection (a); and 

19 (B) the State law shall apply instead of the 

20 patient protection requirement otherwise appli21 cable with respect to health insurance coverage 

22 and non-Federal governmental plans. 

23 (2) LIMITATION.—In the case of a group health 

24 plan covered under title I of the Employee Retire25 ment Income Security Act of 1974, paragraph (1) 
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1 shall be construed to apply only with respect to the 

2 health insurance coverage (if any) offered in connec3 tion with the plan. 

4 (3) DEFINITIONS.—In this section: 

5 (A) PATIENT PROTECTION REQUIRE6 MENT.—The term ‘‘patient protection require7 ment’’ means a requirement under this title, 

8 and includes (as a single requirement) a group 

9 or related set of requirements under a section 

10 or similar unit under this title. 

11 (B) SUBSTANTIALLY COMPLIANT.—The 

12 terms ‘‘substantially compliant’’, ‘‘substantially 

13 complies’’, or ‘‘substantial compliance’’ with re14 spect to a State law, mean that the State law 

15 has the same or similar features as the patient 

16 protection requirements and has a similar ef17 fect. 

18 (c) DETERMINATIONS OF SUBSTANTIAL COMPLI19 ANCE.— 

20 (1) CERTIFICATION BY STATES.—A State may 

21 submit to the Secretary a certification that a State 

22 law provides for patient protections that are at least 

23 substantially compliant with one or more patient 

24 protection requirements. Such certification shall be 

25 accompanied by such information as may be re-
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1 quired to permit the Secretary to make the deter2 mination described in paragraph (2)(A). 

3 (2) REVIEW.— 

4 (A) IN GENERAL.—The Secretary shall 

5 promptly review a certification submitted under 

6 paragraph (1) with respect to a State law to de7 termine if the State law substantially complies 

8 with the patient protection requirement (or re9 quirements) to which the law relates. 

10 (B) APPROVAL DEADLINES.— 

11 (i) INITIAL REVIEW.—Such a certifi12 cation is considered approved unless the 

13 Secretary notifies the State in writing, 

14 within 90 days after the date of receipt of 

15 the certification, that the certification is 

16 disapproved (and the reasons for dis17 approval) or that specified additional infor18 mation is needed to make the determina19 tion described in subparagraph (A). 

20 (ii) ADDITIONAL INFORMATION.— 

21 With respect to a State that has been noti22 fied by the Secretary under clause (i) that 

23 specified additional information is needed 

24 to make the determination described in 

25 subparagraph (A), the Secretary shall 
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1 make the determination within 60 days 

2 after the date on which such specified ad3 ditional information is received by the Sec4 retary. 

5 (3) APPROVAL.— 

6 (A) IN GENERAL.—The Secretary shall ap7 prove a certification under paragraph (1) un8 less— 

9 (i) the State fails to provide sufficient 

10 information to enable the Secretary to 

11 make a determination under paragraph 

12 (2)(A); or 

13 (ii) the Secretary determines that the 

14 State law involved does not provide for pa15 tient protections that substantially comply 

16 with the patient protection requirement (or 

17 requirements) to which the law relates. 

18 (B) STATE CHALLENGE.—A State that has 

19 a certification disapproved by the Secretary 

20 under subparagraph (A) may challenge such 

21 disapproval in the appropriate United States 

22 district court. 

23 (C) DEFERENCE TO STATES.—With re24 spect to a certification submitted under para25 graph (1), the Secretary shall give deference to 
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1 the State’s interpretation of the State law in2 volved with respect to the patient protection in3 volved. 

4 (D) PUBLIC NOTIFICATION.—The Sec5 retary shall— 

6 (i) provide a State with a notice of the 

7 determination to approve or disapprove a 

8 certification under this paragraph; 

9 (ii) promptly publish in the Federal 

10 Register a notice that a State has sub11 mitted a certification under paragraph (1); 

12 (iii) promptly publish in the Federal 

13 Register the notice described in clause (i) 

14 with respect to the State; and 

15 (iv) annually publish the status of all 

16 States with respect to certifications. 

17 (4) CONSTRUCTION.—Nothing in this sub18 section shall be construed as preventing the certifi19 cation (and approval of certification) of a State law 

20 under this subsection solely because it provides for 

21 greater protections for patients than those protec22 tions otherwise required to establish substantial 

23 compliance. 

24 (5) PETITIONS.— 
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1 (A) PETITION PROCESS.—Effective on the 

2 date on which the provisions of this Act become 

3 effective, as provided for in section 601, a 

4 group health plan, health insurance issuer, par5 ticipant, beneficiary, or enrollee may submit a 

6 petition to the Secretary for an advisory opinion 

7 as to whether or not a standard or requirement 

8 under a State law applicable to the plan, issuer, 

9 participant, beneficiary, or enrollee that is not 

10 the subject of a certification under this sub11 section, is superseded under subsection (a)(1) 

12 because such standard or requirement prevents 

13 the application of a requirement of this title. 

14 (B) OPINION.—The Secretary shall issue 

15 an advisory opinion with respect to a petition 

16 submitted under subparagraph (A) within the 

17 60-day period beginning on the date on which 

18 such petition is submitted. 

19 (d) DEFINITIONS.—For purposes of this section: 

20 (1) STATE LAW.—The term ‘‘State law’’ in21 cludes all laws, decisions, rules, regulations, or other 

22 State action having the effect of law, of any State. 

23 A law of the United States applicable only to the 

24 District of Columbia shall be treated as a State law 

25 rather than a law of the United States. 
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1 (2) STATE.—The term ‘‘State’’ includes a 

2 State, the District of Columbia, Puerto Rico, the 

3 Virgin Islands, Guam, American Samoa, the North4 ern Mariana Islands, any political subdivisions of 

5 such, or any agency or instrumentality of such. 

6 SEC. 153. EXCLUSIONS. 

7 (a) NO BENEFIT REQUIREMENTS.—Nothing in this 

8 title shall be construed to require a group health plan or 

9 a health insurance issuer offering health insurance cov10 erage to include specific items and services under the 

11 terms of such a plan or coverage, other than those pro12 vided under the terms and conditions of such plan or cov13 erage. 

14 (b) EXCLUSION FROM ACCESS TO CARE MANAGED

15 CARE PROVISIONS FOR FEE-FOR-SERVICE COVERAGE.— 

16 (1) IN GENERAL.—The provisions of sections 

17 111 through 117 shall not apply to a group health 

18 plan or health insurance coverage if the only cov19 erage offered under the plan or coverage is fee-for20 service coverage (as defined in paragraph (2)). 

21 (2) FEE-FOR-SERVICE COVERAGE DEFINED.— 

22 For purposes of this subsection, the term ‘‘fee-for23 service coverage’’ means coverage under a group 

24 health plan or health insurance coverage that— 
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1 (A) reimburses hospitals, health profes2 sionals, and other providers on a fee-for-service 

3 basis without placing the provider at financial 

4 risk; 

5 (B) does not vary reimbursement for such 

6 a provider based on an agreement to contract 

7 terms and conditions or the utilization of health 

8 care items or services relating to such provider; 

9 (C) allows access to any provider that is 

10 lawfully authorized to provide the covered serv11 ices and that agrees to accept the terms and 

12 conditions of payment established under the 

13 plan or by the issuer; and 

14 (D) for which the plan or issuer does not 

15 require prior authorization before providing for 

16 any health care services. 

17 SEC. 154. TREATMENT OF EXCEPTED BENEFITS. 

18 (a) IN GENERAL.—The requirements of this title 

19 shall not apply to excepted benefits (as defined in section 

20 733(c) of such Act), other than benefits described in sec21 tion 733(c)(2)(A) of such Act, in the same manner as the 

22 provisions of part 7 of subtitle B of title I of such Act 

23 do not apply to such benefits under subsections (b) and 

24 (c) of section 732 of such Act. 
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1 (b) COVERAGE OF CERTAIN LIMITED SCOPE

2 PLANS.—Only for purposes of applying the requirements 

3 of this title under sections 2707 and 2753 of the Public 

4 Health Service Act, section 714 of the Employee Retire5 ment Income Security Act of 1974, and section 9813 of 

6 the Internal Revenue Code of 1986, the following sections 

7 shall be deemed not to apply: 

8 (1) Section 2791(c)(2)(A) of the Public Health 

9 Service Act. 

10 (2) Section 733(c)(2)(A) of the Employee Re11 tirement Income Security Act of 1974. 

12 (3) Section 9832(c)(2)(A) of the Internal Rev13 enue Code of 1986. 

14 SEC. 155. REGULATIONS. 

15 The Secretaries of Health and Human Services, 

16 Labor, and the Treasury shall issue such regulations as 

17 may be necessary or appropriate to carry out this title. 

18 Such regulations shall be issued consistent with section 

19 104 of Health Insurance Portability and Accountability 

20 Act of 1996. Such Secretaries may promulgate any in21 terim final rules as the Secretaries determine are appro22 priate to carry out this title. 
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1 SEC. 156. INCORPORATION INTO PLAN OR COVERAGE DOC2 UMENTS. 

3 The requirements of this title with respect to a group 

4 health plan or health insurance coverage are, subject to 

5 section 154, deemed to be incorporated into, and made 

6 a part of, such plan or the policy, certificate, or contract 

7 providing such coverage and are enforceable under law as 

8 if directly included in the documentation of such plan or 

9 such policy, certificate, or contract. 

10 SEC. 157. PRESERVATION OF PROTECTIONS. 

11 (a) IN GENERAL.—The rights under this Act (includ12 ing the right to maintain a civil action and any other 

13 rights under the amendments made by this Act) may not 

14 be waived, deferred, or lost pursuant to any agreement 

15 not authorized under this Act. 

16 (b) EXCEPTION.—Subsection (a) shall not apply to 

17 an agreement providing for arbitration or participation in 

18 any other nonjudicial procedure to resolve a dispute if the 

19 agreement is entered into knowingly and voluntarily by the 

20 parties involved after the dispute has arisen or is pursuant 

21 to the terms of a collective bargaining agreement. Nothing 

22 in this subsection shall be construed to permit the waiver 

23 of the requirements of sections 103 and 104 (relating to 

24 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 Patient Pro15 tection Act of 2005, and each health insurance issuer shall 

16 comply with patient protection requirements under such 

17 title with respect to group health insurance coverage it of18 fers, and such requirements shall be deemed to be incor19 porated 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 Patient 

9 Protection Act of 2005 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 Patient Protection Act of 2005 with 

24 respect to health insurance coverage offered by a health 

25 insurance issuer and with respect to a group health plan 

26 that is a non-Federal governmental plan. 
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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 Patient Protection Act of 2005 (as in effect as of the 

18 date of the enactment of such Act), and such requirements 

19 shall be deemed to be incorporated into this subsection. 

20 ‘‘(b) PLAN SATISFACTION OF CERTAIN REQUIRE21 MENTS.— 

22 ‘‘(1) SATISFACTION OF CERTAIN REQUIRE23 MENTS THROUGH INSURANCE.—For purposes of 

24 subsection (a), insofar as a group health plan pro25 vides benefits in the form of health insurance cov-
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1 erage through a health insurance issuer, the plan 

2 shall be treated as meeting the following require3 ments of title I of the Patient Protection Act of 

4 2005 with respect to such benefits and not be con5 sidered as failing to meet such requirements because 

6 of a failure of the issuer to meet such requirements 

7 so long as the plan sponsor or its representatives did 

8 not cause such failure by the issuer: 

9 ‘‘(A) Section 111 (relating to consumer 

10 choice option). 

11 ‘‘(B) Section 112 (relating to choice of 

12 health care professional). 

13 ‘‘(C) Section 113 (relating to access to 

14 emergency care). 

15 ‘‘(D) Section 114 (relating to timely access 

16 to specialists). 

17 ‘‘(E) Section 115 (relating to patient ac18 cess to obstetrical and gynecological care). 

19 ‘‘(F) Section 116 (relating to access to pe20 diatric care). 

21 ‘‘(G) Section 117 (relating to continuity of 

22 care), but only insofar as a replacement issuer 

23 assumes the obligation for continuity of care. 

24 ‘‘(H) Section 118 (relating to access to 

25 needed prescription drugs). 
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1 ‘‘(I) Section 119 (relating to coverage for 

2 individuals participating in approved clinical 

3 trials). 

4 ‘‘(J) Section 120 (relating to required cov5 erage for minimum hospital stay for 

6 mastectomies and lymph node dissections for 

7 the treatment of breast cancer and coverage for 

8 secondary consultations). 

9 ‘‘(K) Section 134 (relating to payment of 

10 claims). 

11 ‘‘(2) INFORMATION.—With respect to informa12 tion required to be provided or made available under 

13 section 121 of the Patient Protection Act of 2005, 

14 in the case of a group health plan that provides ben15 efits in the form of health insurance coverage 

16 through a health insurance issuer, the Secretary 

17 shall determine the circumstances under which the 

18 plan is not required to provide or make available the 

19 information (and is not liable for the issuer’s failure 

20 to provide or make available the information), if the 

21 issuer is obligated to provide and make available (or 

22 provides and makes available) such information. 

23 ‘‘(3) INTERNAL APPEALS.—With respect to the 

24 internal appeals process required to be established 

25 under section 103 of such Act, in the case of a 
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1 group health plan that provides benefits in the form 

2 of health insurance coverage through a health insur3 ance issuer, the Secretary shall determine the cir4 cumstances under which the plan is not required to 

5 provide for such process and system (and is not lia6 ble for the issuer’s failure to provide for such proc7 ess and system), if the issuer is obligated to provide 

8 for (and provides for) such process and system. 

9 ‘‘(4) EXTERNAL APPEALS.—Pursuant to rules 

10 of the Secretary, insofar as a group health plan en11 ters into a contract with a qualified external appeal 

12 entity for the conduct of external appeal activities in 

13 accordance with section 104 of such Act, the plan 

14 shall be treated as meeting the requirement of such 

15 section and is not liable for the entity’s failure to 

16 meet any requirements under such section. 

17 ‘‘(5) APPLICATION TO PROHIBITIONS.—Pursu18 ant to rules of the Secretary, if a health insurance 

19 issuer offers health insurance coverage in connection 

20 with a group health plan and takes an action in vio21 lation of any of the following sections of the Patient 

22 Protection Act of 2005, the group health plan shall 

23 not be liable for such violation unless the plan 

24 caused such violation: 
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1 ‘‘(A) Section 131 (relating to prohibition of 

2 interference with certain medical communica3 tions). 

4 ‘‘(B) Section 132 (relating to prohibition 

5 of discrimination against providers based on li6 censure). 

7 ‘‘(C) Section 133 (relating to prohibition 

8 against improper incentive arrangements). 

9 ‘‘(D) Section 135 (relating to protection 

10 for patient advocacy). 

11 ‘‘(6) CONSTRUCTION.—Nothing in this sub12 section shall be construed to affect or modify the re13 sponsibilities of the fiduciaries of a group health 

14 plan under part 4 of subtitle B. 

15 ‘‘(7) TREATMENT OF SUBSTANTIALLY COMPLI16 ANT STATE LAWS.—For purposes of applying this 

17 subsection in connection with health insurance cov18 erage, any reference in this subsection to a require19 ment in a section or other provision in the Patient 

20 Protection Act of 2005 with respect to a health in21 surance issuer is deemed to include a reference to a 

22 requirement under a State law that substantially 

23 complies (as determined under section 152(c) of 

24 such Act) with the requirement in such section or 

25 other provisions. 
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1 ‘‘(8) APPLICATION TO CERTAIN PROHIBITIONS

2 AGAINST RETALIATION.—With respect to compliance 

3 with the requirements of section 135(b)(1) of the 

4 Patient Protection Act of 2005, for purposes of this 

5 subtitle the term ‘group health plan’ is deemed to in6 clude a reference to an institutional health care pro7 vider. 

8 ‘‘(c) ENFORCEMENT OF CERTAIN REQUIREMENTS.— 

9 ‘‘(1) COMPLAINTS.—Any protected health care 

10 professional who believes that the professional has 

11 been retaliated or discriminated against in violation 

12 of section 135(b)(1) of the Patient Protection Act of 

13 2005 may file with the Secretary a complaint within 

14 180 days of the date of the alleged retaliation or dis15 crimination. 

16 ‘‘(2) INVESTIGATION.—The Secretary shall in17 vestigate such complaints and shall determine if a 

18 violation of such section has occurred and, if so, 

19 shall issue an order to ensure that the protected 

20 health care professional does not suffer any loss of 

21 position, pay, or benefits in relation to the plan, 

22 issuer, or provider involved, as a result of the viola23 tion found by the Secretary. 

24 ‘‘(d) CONFORMING REGULATIONS.—The Secretary 

25 shall issue regulations to coordinate the requirements on 
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1 group health plans and health insurance issuers under this 

2 section with the requirements imposed under the other 

3 provisions of this title. In order to reduce duplication and 

4 clarify the rights of participants and beneficiaries with re5 spect to information that is required to be provided, such 

6 regulations shall coordinate the information disclosure re7 quirements under section 121 of the Patient Protection 

8 Act of 2005 with the reporting and disclosure require9 ments imposed under part 1, so long as such coordination 

10 does not result in any reduction in the information that 

11 would otherwise be provided to participants and bene12 ficiaries.’’. 

13 (b) SATISFACTION OF ERISA CLAIMS PROCEDURE

14 REQUIREMENT.—Section 503 of such Act (29 U.S.C. 

15 1133) is amended by inserting ‘‘(a)’’ after ‘‘Sec. 503.’’ and 

16 by adding at the end the following new subsection: 

17 ‘‘(b) In the case of a group health plan (as defined 

18 in section 733), compliance with the requirements of sub19 title A of title I of the Patient Protection Act of 2005, 

20 and compliance with regulations promulgated by the Sec21 retary, in the case of a claims denial, shall be deemed com22 pliance with subsection (a) with respect to such claims de23 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. COOPERATION BETWEEN FEDERAL AND STATE 

11 AUTHORITIES. 

12 Subpart C of part 7 of subtitle B of title I of the 

13 Employee Retirement Income Security Act of 1974 (29 

14 U.S.C. 1191 et seq.) is amended by adding at the end 

15 the following new section: 

16 ‘‘SEC. 735. COOPERATION BETWEEN FEDERAL AND STATE 

17 AUTHORITIES. 

18 ‘‘(a) AGREEMENT WITH STATES.—A State may 

19 enter into an agreement with the Secretary for the delega20 tion to the State of some or all of the Secretary’s authority 

21 under this title to enforce the requirements applicable 

22 under title I of the Patient Protection Act of 2005 with 

23 respect to health insurance coverage offered by a health 

24 insurance issuer. 
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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 SEC. 403. SENSE OF THE CONGRESS CONCERNING THE IM8 PORTANCE OF CERTAIN UNPAID SERVICES. 

9 It is the sense of the Congress that the court should 

10 consider the loss of a nonwage earning spouse or parent 

11 as an economic loss for the purposes of this section. Fur12 thermore, the court should define the compensation for the 

13 loss not as minimum services, but, rather, in terms that 

14 fully compensate for the true and whole replacement cost 

15 to the family. 

16 TITLE V—AMENDMENTS TO THE 

17 INTERNAL REVENUE CODE 

18 OF 1986 

19 SEC. 501. APPLICATION TO GROUP HEALTH PLANS UNDER 

20 THE INTERNAL REVENUE CODE OF 1986. 

21 Subchapter B of chapter 100 of the Internal Revenue 

22 Code of 1986 is amended— 

23 (1) in the table of sections, by inserting after 

24 the item relating to section 9812 the following new 

25 item: 

‘‘9813. Standard relating to patients’ bill of rights.’’; 
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1 and 

2 (2) by inserting after section 9812 the fol3 lowing: 

4 ‘‘SEC. 9813. STANDARD RELATING TO PATIENTS’ BILL OF 

5 RIGHTS. 

6 ‘‘A group health plan shall comply with the require7 ments of title I of the Patient Protection Act of 2005 (as 

8 in effect as of the date of the enactment of such Act), 

9 and such requirements shall be deemed to be incorporated 

10 into this section.’’. 

11 SEC. 502. CONFORMING ENFORCEMENT FOR WOMEN’S 

12 HEALTH AND CANCER RIGHTS. 

13 Subchapter B of chapter 100 of the Internal Revenue 

14 Code of 1986, as amended by section 501, is further 

15 amended— 

16 (1) in the table of sections, by inserting after 

17 the item relating to section 9813 the following new 

18 item: 

‘‘9814. Standard relating to women’s health and cancer rights.’’; 

19 and 

20 (2) by inserting after section 9813 the fol21 lowing: 

22 ‘‘SEC. 9814. STANDARD RELATING TO WOMEN’S HEALTH 

23 AND CANCER RIGHTS. 

24 ‘‘The provisions of section 713 of the Employee Re25 tirement Income Security Act of 1974 (as in effect as of 
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1 the date of the enactment of this section) shall apply to 

2 group health plans as if included in this subchapter.’’. 

3 TITLE VI—EFFECTIVE DATES; 

4 COORDINATION IN IMPLE5 MENTATION 

6 SEC. 601. EFFECTIVE DATES. 

7 (a) GROUP HEALTH COVERAGE.— 

8 (1) IN GENERAL.—Subject to paragraph (2) 

9 and subsection (d), the amendments made by sec10 tions 201(a), 401, 501, and 502 (and title I insofar 

11 as it relates to such sections) shall apply with re12 spect to group health plans, and health insurance 

13 coverage offered in connection with group health 

14 plans, for plan years beginning on or after October 

15 1, 2005 (in this section referred to as the ‘‘general 

16 effective date’’). 

17 (2) TREATMENT OF COLLECTIVE BARGAINING

18 AGREEMENTS.—In the case of a group health plan 

19 maintained pursuant to one or more collective bar20 gaining agreements between employee representa21 tives and one or more employers ratified before the 

22 date of the enactment of this Act, the amendments 

23 made by sections 201(a), 401, 501, and 502 (and 

24 title I insofar as it relates to such sections) shall not 

25 apply to plan years beginning before the later of— 
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1 (A) the date on which the last collective 

2 bargaining agreements relating to the plan ter3 minates (excluding any extension thereof agreed 

4 to after the date of the enactment of this Act); 

5 or 

6 (B) the general effective date; 

7 but shall apply not later than 1 year after the gen8 eral effective date. For purposes of subparagraph 

9 (A), any plan amendment made pursuant to a collec10 tive bargaining agreement relating to the plan which 

11 amends the plan solely to conform to any require12 ment added by this Act shall not be treated as a ter13 mination of such collective bargaining agreement. 

14 (b) INDIVIDUAL HEALTH INSURANCE COVERAGE.— 

15 Subject to subsection (d), the amendments made by sec16 tion 202 shall apply with respect to individual health in17 surance coverage offered, sold, issued, renewed, in effect, 

18 or operated in the individual market on or after the gen19 eral effective date. 

20 (c) TREATMENT OF RELIGIOUS NONMEDICAL PRO21 VIDERS.— 

22 (1) IN GENERAL.—Nothing in this Act (or the 

23 amendments made thereby) shall be construed to— 

24 (A) restrict or limit the right of group 

25 health plans, and of health insurance issuers of-
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1 fering health insurance coverage, to include as 

2 providers religious nonmedical providers; 

3 (B) require such plans or issuers to— 

4 (i) utilize medically based eligibility 

5 standards or criteria in deciding provider 

6 status of religious nonmedical providers; 

7 (ii) use medical professionals or cri8 teria to decide patient access to religious 

9 nonmedical providers; 

10 (iii) utilize medical professionals or 

11 criteria in making decisions in internal or 

12 external appeals regarding coverage for 

13 care by religious nonmedical providers; or 

14 (iv) compel a participant or bene15 ficiary to undergo a medical examination 

16 or test as a condition of receiving health 

17 insurance coverage for treatment by a reli18 gious nonmedical provider; or 

19 (C) require such plans or issuers to ex20 clude religious nonmedical providers because 

21 they do not provide medical or other required 

22 data, if such data is inconsistent with the reli23 gious nonmedical treatment or nursing care 

24 provided by the provider. 
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1 (2) RELIGIOUS NONMEDICAL PROVIDER.—For 

2 purposes of this subsection, the term ‘‘religious non3 medical provider’’ means a provider who provides no 

4 medical care but who provides only religious non5 medical treatment or religious nonmedical nursing 

6 care. 

7 (d) TRANSITION FOR NOTICE REQUIREMENT.—The 

8 disclosure of information required under section 121 of 

9 this Act shall first be provided pursuant to— 

10 (1) subsection (a) with respect to a group 

11 health plan that is maintained as of the general ef12 fective date, not later than 30 days before the begin13 ning of the first plan year to which title I applies 

14 in connection with the plan under such subsection; 

15 or 

16 (2) subsection (b) with respect to an individual 

17 health insurance coverage that is in effect as of the 

18 general effective date, not later than 30 days before 

19 the first date as of which title I applies to the cov20 erage under such subsection. 

21 SEC. 602. COORDINATION IN IMPLEMENTATION. 

22 The Secretary of Labor and the Secretary of Health 

23 and Human Services shall ensure, through the execution 

24 of an interagency memorandum of understanding among 

25 such Secretaries, that— 
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1 (1) regulations, rulings, and interpretations 

2 issued by such Secretaries relating to the same mat3 ter over which such Secretaries have responsibility 

4 under the provisions of this Act (and the amend5 ments made thereby) are administered so as to have 

6 the same effect at all times; and 

7 (2) coordination of policies relating to enforcing 

8 the same requirements through such Secretaries in 

9 order to have a coordinated enforcement strategy 

10 that avoids duplication of enforcement efforts and 

11 assigns priorities in enforcement. 

12 SEC. 603. SEVERABILITY. 

13 If any provision of this Act, an amendment made by 

14 this Act, or the application of such provision or amend15 ment to any person or circumstance is held to be unconsti16 tutional, the remainder of this Act, the amendments made 

17 by this Act, and the application of the provisions of such 

18 to any person or circumstance shall not be affected there19 by. 

20 TITLE VII—MISCELLANEOUS 

21 PROVISIONS 

22 SEC. 701. NO IMPACT ON SOCIAL SECURITY TRUST FUND. 

23 (a) IN GENERAL.—Nothing in this Act (or an amend24 ment made by this Act) shall be construed to alter or 
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1 amend the Social Security Act (or any regulation promul2 gated under that Act). 

3 (b) TRANSFERS.— 

4 (1) ESTIMATE OF SECRETARY.—The Secretary 

5 of the Treasury shall annually estimate the impact 

6 that the enactment of this Act has on the income 

7 and balances of the trust funds established under 

8 section 201 of the Social Security Act (42 U.S.C. 

9 401). 

10 (2) TRANSFER OF FUNDS.—If, under para11 graph (1), the Secretary of the Treasury estimates 

12 that the enactment of this Act has a negative impact 

13 on the income and balances of the trust funds estab14 lished under section 201 of the Social Security Act 

15 (42 U.S.C. 401), the Secretary shall transfer, not 

16 less frequently than quarterly, from the general reve17 nues of the Federal Government an amount suffi18 cient so as to ensure that the income and balances 

19 of such trust funds are not reduced as a result of 

20 the enactment of such Act. 

21 SEC. 702. SENSE OF CONGRESS WITH RESPECT TO PARTICI22 PATION IN CLINICAL TRIALS AND ACCESS TO 

23 SPECIALTY CARE. 

24 (a) FINDINGS.—The Congress finds the following: 
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1 (1) Breast cancer is the most common form of 

2 cancer among women, excluding skin cancers. 

3 (2) During 2005, 211,240 new cases of female 

4 breast cancer are projected to be diagnosed, and an 

5 estimated 40,410 women are projected to die from 

6 the disease. 

7 (3) During 2005, 1,690 male breast cancer 

8 cases are projected to be diagnosed, and 460 men 

9 are projected to die from the disease. 

10 (4) Breast cancer is the second leading cause of 

11 cancer death among all women and a leading cause 

12 of cancer death among women between ages 40 and 

13 55. 

14 (5) During 2004, 9,200 children were projected 

15 to be diagnosed with cancer. 

16 (6) During 2004, 1,510 children were projected 

17 to die from cancer. 

18 (7) There are approximately 400,000 people di19 agnosed with multiple sclerosis in the United States 

20 and approximately 250 new cases are diagnosed 

21 each week. 

22 (8) Parkinson’s disease is a chronic and pro23 gressive disorder of the central nervous system, af24 fecting as many as 1,500,000 people in the United 

25 States. 
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1 (9) During 2005, 232,090 men are projected to 

2 be diagnosed with prostate cancer. 

3 (10) During 2005, 30,350 men are projected to 

4 die from prostate cancer. It is the second leading 

5 cause of cancer death in men. 

6 (11) Information obtained from clinical trials is 

7 essential to improve the way diseases are prevented, 

8 screened for, diagnosed, and treated. While there are 

9 already measures in place, clinical trials are not 

10 without risk. Future efforts should be taken in addi11 tion to those already undertaken to protect the 

12 health and safety of adults and children who enroll 

13 in clinical trials. Some of these include the use of in14 stitutional review boards, informed consent, and 

15 data safety monitoring boards. 

16 (12) While employers and health plans should 

17 be responsible for covering the routine costs associ18 ated with Federally approved or funded clinical 

19 trials, such employers and health plans should not 

20 be held legally responsible for the design, implemen21 tation, or outcome of such clinical trials, consistent 

22 with any applicable State or Federal liability stat23 utes. 

24 (13) By passing legislation or instituting special 

25 agreements, 21 states now require that insurance 
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1 companies cover the routine costs of medical care for 

2 patients who enroll on a clinical trial. There is little 

3 information available regarding the effect these laws 

4 and agreements have had on clinical trial participa5 tion. 

6 (14) When evaluating clinical trial participa7 tion, it is vital to review the issues of quantity and 

8 quality. Identifying as many patients as possible who 

9 meet the eligibility criteria to participate in a clinical 

10 trial, and providing all of those eligible patients with 

11 the opportunity to decide whether or not to enroll, 

12 are together one important aspect. Having quality 

13 clinical trials available which utilize sound scientific 

14 and ethical guidelines to answer imminent questions 

15 related to particular diseases is also quite important. 

16 (b) SENSE OF THE CONGRESS.—It is the sense of 

17 the Congress that— 

18 (1) men and women battling life-threatening, 

19 deadly diseases, including advanced breast or ovar20 ian cancer, should have the opportunity to partici21 pate in a Federally approved or funded clinical trial 

22 recommended by their physician; 

23 (2) an individual should have the opportunity to 

24 participate in a Federally approved or funded clin25 ical trial recommended by their physician if— 
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1 (A) that individual— 

2 (i) has a life-threatening or serious ill3 ness for which no standard treatment is ef4 fective; or 

5 (ii) is eligible to participate in a Fed6 erally approved or funded clinical trial ac7 cording to the trial protocol with respect to 

8 treatment of the illness; 

9 (B) that individual’s participation in the 

10 trial offers meaningful potential for significant 

11 clinical benefit for the individual; and 

12 (C) either— 

13 (i) the referring physician is a partici14 pating health care professional and has 

15 concluded that the individual’s participa16 tion in the trial would be appropriate, 

17 based upon the individual meeting the con18 ditions described in subparagraph (A); or 

19 (ii) the participant, beneficiary, or en20 rollee provides medical and scientific infor21 mation establishing that the individual’s 

22 participation in the trial would be appro23 priate, based upon the individual meeting 

24 the conditions described in subparagraph 

25 (A); 
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1 (3) a child with a life-threatening illness, in2 cluding cancer, should be allowed to participate in a 

3 Federally approved or funded clinical trial if that 

4 participation meets the requirements of paragraph 

5 (2); 

6 (4) a child with a rare cancer should be allowed 

7 to go to a cancer center capable of providing high 

8 quality care for that disease; and 

9 (5) a health maintenance organization’s deci10 sion that an in-network physician without the nec11 essary expertise can provide care for a seriously ill 

12 patient, including a woman battling cancer, should 

13 be appealable to an independent, impartial body, and 

14 that this same right should be available to all Ameri15 cans in need of access to high quality specialty care. 

16 SEC. 703. SENSE OF THE CONGRESS REGARDING FAIR RE17 VIEW PROCESS. 

18 (a) FINDINGS.—The Congress finds the following: 

19 (1) A fair, timely, impartial independent exter20 nal appeals process is essential to any meaningful 

21 program of patient protection. 

22 (2) The independence and objectivity of the re23 view organization and review process must be en24 sured. 
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1 (3) It is incompatible with a fair and inde2 pendent appeals process to allow a health mainte3 nance organization to select the review organization 

4 that is entrusted with providing a neutral and unbi5 ased medical review. 

6 (4) The American Arbitration Association and 

7 arbitration standards adopted under chapter 44 of 

8 title 28, United States Code (28 U.S.C. 651 et seq.) 

9 both prohibit, as inherently unfair, the right of one 

10 party to a dispute to choose the judge in that dis11 pute. 

12 (b) SENSE OF THE CONGRESS.—It is the sense of 

13 the Congress that— 

14 (1) every patient who is denied care by a health 

15 maintenance organization or other health insurance 

16 company should be entitled to a fair, speedy, impar17 tial appeal to a review organization that has not 

18 been selected by the health plan; 

19 (2) the States should be empowered to maintain 

20 and develop the appropriate process for selection of 

21 the independent external review entity; 

22 (3) a child battling a rare cancer whose health 

23 maintenance organization has denied a covered 

24 treatment recommended by its physician should be 

25 entitled to a fair and impartial external appeal to a 
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1 review organization that has not been chosen by the 

2 organization or plan that has denied the care; and 

3 (4) patient protection legislation should not pre4 empt existing State laws in States where there al5 ready are strong laws in place regarding the selec6 tion of independent review organizations. 

7 SEC. 704. ANNUAL REVIEW. 

8 (a) IN GENERAL.—Not later than 24 months after 

9 the general effective date referred to in section 601(a)(1), 

10 and annually thereafter for each of the succeeding 4 cal11 endar years (or until a repeal is effective under subsection 

12 (b)), the Secretary of Health and Human Services shall 

13 request that the Institute of Medicine of the National 

14 Academy of Sciences prepare and submit to the appro15 priate committees of Congress a report concerning the im16 pact of this Act, and the amendments made by this Act, 

17 on the number of individuals in the United States with 

18 health insurance coverage. 

19 (b) FUNDING.—From funds appropriated to the De20 partment of Health and Human Services for fiscal years 

21 2006 and 2007, the Secretary of Health and Human Serv22 ices shall provide for such funding as the Secretary deter23 mines necessary for the conduct of the study of the Na24 tional Academy of Sciences under this section. 

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