II 

108TH CONGRESS 

2D SESSION S. 2083

To amend the Public Health Service Act and the Employee Retirement 

Income Security Act of 1974 to protect consumers in managed care 

plans and other health coverage. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 12, 2004

Mrs. BOXER introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL

To amend the Public Health Service Act and the Employee 

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

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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘Bipartisan Patient Protection Act of 2004’’. 

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

7 this Act is as follows:

Sec. 1. Short title; table of contents. 

TITLE I—IMPROVING MANAGED CARE 

Subtitle A—Utilization Review; Claims; and Internal and External Appeals 
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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. 

Sec. 122. Genetic information. 

Subtitle D—Protecting the Doctor-Patient Relationship 

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

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

Sec. 133. Prohibition against improper incentive arrangements. 

Sec. 134. Payment of claims. 

Sec. 135. Protection for patient advocacy. 

Subtitle E—Definitions 

Sec. 151. Definitions. 

Sec. 152. Preemption; State flexibility; construction. 

Sec. 153. Exclusions. 

Sec. 154. Coverage of limited scope plans. 

Sec. 155. Regulations. 

Sec. 156. Incorporation into plan or coverage documents. 

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. 

Sec. 204. Elimination of option of non-Federal governmental plans to be excepted from requirements concerning genetic information. 

TITLE III—APPLICATION OF PATIENT PROTECTION STANDARDS 

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

programs. 

TITLE IV—AMENDMENTS TO THE EMPLOYEE RETIREMENT 

INCOME SECURITY ACT OF 1974

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

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

Sec. 402. Availability of civil remedies. 

Sec. 403. Limitation on certain class action litigation. 

Sec. 404. Limitations on actions. 

Sec. 405. Cooperation between Federal and State authorities. 

Sec. 406. Sense of the senate concerning the importance of certain unpaid services. 

TITLE V—EFFECTIVE DATES; COORDINATION IN 

IMPLEMENTATION 

Sec. 501. Effective dates. 

Sec. 502. Coordination in implementation. 

Sec. 503. Severability. 

TITLE VI—MISCELLANEOUS PROVISIONS 

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

Sec. 602. Customs user fees. 

Sec. 603. Fiscal year 2005 medicare payments. 

Sec. 604. Sense of Senate with respect to participation in clinical trials and access to specialty care. 

Sec. 605. Sense of the Senate regarding fair review process. 

Sec. 606. Annual review.

1 TITLE I—IMPROVING MANAGED 

2 CARE 

3 Subtitle A—Utilization Review; 

4 Claims; and Internal and Exter5 nal Appeals 

6 SEC. 101. UTILIZATION REVIEW ACTIVITIES. 

7 (a) COMPLIANCE WITH REQUIREMENTS.—

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

9 health insurance issuer that provides health insur10 ance coverage, shall conduct utilization review activi11 ties in connection with the provision of benefits 
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1 under such plan or coverage only in accordance with 

2 a utilization review program that meets the require3 ments of this section and section 102. 

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

5 section shall be construed as preventing a group 

6 health plan or health insurance issuer from arrang7 ing through a contract or otherwise for persons or 

8 entities to conduct utilization review activities on be9 half of the plan or issuer, so long as such activities 

10 are conducted in accordance with a utilization review 

11 program that meets the requirements of this section. 

12 (3) UTILIZATION REVIEW DEFINED.—For pur13 poses of this section, the terms ‘‘utilization review’’ 

14 and ‘‘utilization review activities’’ mean procedures 

15 used to monitor or evaluate the use or coverage, 

16 clinical necessity, appropriateness, efficacy, or effi17 ciency of health care services, procedures or settings, 

18 and includes prospective review, concurrent review, 

19 second opinions, case management, discharge plan20 ning, or retrospective review. 

21 (b) WRITTEN POLICIES AND CRITERIA.—

22 (1) WRITTEN POLICIES.—A utilization review 

23 program shall be conducted consistent with written 

24 policies and procedures that govern all aspects of the 

25 program. 
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1 (2) USE OF WRITTEN CRITERIA.—

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

3 utilize written clinical review criteria developed 

4 with input from a range of appropriate actively 

5 practicing health care professionals, as deter6 mined by the plan, pursuant to the program. 

7 Such criteria shall include written clinical re8 view criteria that are based on valid clinical evi9 dence where available and that are directed spe10 cifically at meeting the needs of at-risk popu11 lations and covered individuals with chronic 

12 conditions or severe illnesses, including gender13 specific criteria and pediatric-specific criteria 

14 where available and appropriate. 

15 (B) CONTINUING USE OF STANDARDS IN

16 RETROSPECTIVE REVIEW.—If a health care 

17 service has been specifically pre-authorized or 

18 approved for a participant, beneficiary, or en19 rollee under such a program, the program shall 

20 not, pursuant to retrospective review, revise or 

21 modify the specific standards, criteria, or proce22 dures used for the utilization review for proce23 dures, treatment, and services delivered to the 

24 enrollee during the same course of treatment.
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1 (C) REVIEW OF SAMPLE OF CLAIMS DENI2 ALS.—Such a program shall provide for a peri3 odic evaluation of the clinical appropriateness of 

4 at least a sample of denials of claims for bene5 fits. 

6 (c) CONDUCT OF PROGRAM ACTIVITIES.—

7 (1) ADMINISTRATION BY HEALTH CARE PRO8 FESSIONALS.—A utilization review program shall be 

9 administered by qualified health care professionals 

10 who shall oversee review decisions. 

11 (2) USE OF QUALIFIED, INDEPENDENT PER12 SONNEL.—

13 (A) IN GENERAL.—A utilization review 

14 program shall provide for the conduct of utiliza15 tion review activities only through personnel 

16 who are qualified and have received appropriate 

17 training in the conduct of such activities under 

18 the program. 

19 (B) PROHIBITION OF CONTINGENT COM20 PENSATION ARRANGEMENTS.—Such a program 

21 shall not, with respect to utilization review ac22 tivities, permit or provide compensation or any23 thing of value to its employees, agents, or con24 tractors in a manner that encourages denials of 

25 claims for benefits. 
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1 (C) PROHIBITION OF CONFLICTS.—Such a 

2 program shall not permit a health care profes3 sional who is providing health care services to 

4 an individual to perform utilization review ac5 tivities in connection with the health care serv6 ices being provided to the individual. 

7 (3) ACCESSIBILITY OF REVIEW.—Such a pro8 gram shall provide that appropriate personnel per9 forming utilization review activities under the pro10 gram, including the utilization review administrator, 

11 are reasonably accessible by toll-free telephone dur12 ing normal business hours to discuss patient care 

13 and allow response to telephone requests, and that 

14 appropriate provision is made to receive and respond 

15 promptly to calls received during other hours. 

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

17 shall not provide for the performance of utilization 

18 review activities with respect to a class of services 

19 furnished to an individual more frequently than is 

20 reasonably required to assess whether the services 

21 under review are medically necessary and appro22 priate. 
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1 SEC. 102. PROCEDURES FOR INITIAL CLAIMS FOR BENE2 FITS AND PRIOR AUTHORIZATION DETER3 MINATIONS. 

4 (a) PROCEDURES OF INITIAL CLAIMS FOR BENE5 FITS.—

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

7 health insurance issuer offering health insurance 

8 coverage, shall—

9 (A) make a determination on an initial 

10 claim for benefits by a participant, beneficiary, 

11 or enrollee (or authorized representative) re12 garding payment or coverage for items or serv13 ices under the terms and conditions of the plan 

14 or coverage involved, including any cost-sharing 

15 amount that the participant, beneficiary, or en16 rollee is required to pay with respect to such 

17 claim for benefits; and 

18 (B) notify a participant, beneficiary, or en19 rollee (or authorized representative) and the 

20 treating health care professional involved re21 garding a determination on an initial claim for 

22 benefits made under the terms and conditions 

23 of the plan or coverage, including any cost-shar24 ing amounts that the participant, beneficiary, 

25 or enrollee may be required to make with re26 spect to such claim for benefits, and of the 
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1 right of the participant, beneficiary, or enrollee 

2 to an internal appeal under section 103. 

3 (2) ACCESS TO INFORMATION.—

4 (A) TIMELY PROVISION OF NECESSARY IN5 FORMATION.—With respect to an initial claim 

6 for benefits, the participant, beneficiary, or en7 rollee (or authorized representative) and the 

8 treating health care professional (if any) shall 

9 provide the plan or issuer with access to infor10 mation requested by the plan or issuer that is 

11 necessary to make a determination relating to 

12 the claim. Such access shall be provided not 

13 later than 5 days after the date on which the 

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

15 described in subparagraph (B) or (C) of sub16 section (b)(1), by such earlier time as may be 

17 necessary to comply with the applicable timeline 

18 under such subparagraph. 

19 (B) LIMITED EFFECT OF FAILURE ON

20 PLAN OR ISSUER’S OBLIGATIONS.—Failure of 

21 the participant, beneficiary, or enrollee to com22 ply with the requirements of subparagraph (A) 

23 shall not remove the obligation of the plan or 

24 issuer to make a decision in accordance with 

25 the medical exigencies of the case and as soon
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1 as possible, based on the available information, 

2 and failure to comply with the time limit estab3 lished by this paragraph shall not remove the 

4 obligation of the plan or issuer to comply with 

5 the requirements of this section. 

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

7 for benefits involving an expedited or concurrent de8 termination, a participant, beneficiary, or enrollee 

9 (or authorized representative) may make an initial 

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

11 health insurance issuer offering health insurance 

12 coverage, may require that the participant, bene13 ficiary, or enrollee (or authorized representative) 

14 provide written confirmation of such request in a 

15 timely manner on a form provided by the plan or 

16 issuer. In the case of such an oral request for bene17 fits, the making of the request (and the timing of 

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

19 time of a claims for such benefits without regard to 

20 whether and when a written confirmation of such re21 quest is made. 

22 (b) TIMELINE FOR MAKING DETERMINATIONS.—

23 (1) PRIOR AUTHORIZATION DETERMINATION.—

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

25 health insurance issuer offering health insur-
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1 ance coverage, shall make a prior authorization 

2 determination on a claim for benefits (whether 

3 oral or written) in accordance with the medical 

4 exigencies of the case and as soon as possible, 

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

6 on which the plan or issuer receives information 

7 that is reasonably necessary to enable the plan 

8 or issuer to make a determination on the re9 quest for prior authorization and in no case 

10 later than 28 days after the date of the claim 

11 for benefits is received. 

12 (B) EXPEDITED DETERMINATION.—Not13 withstanding subparagraph (A), a group health 

14 plan, or health insurance issuer offering health 

15 insurance coverage, shall expedite a prior au16 thorization determination on a claim for bene17 fits described in such subparagraph when a re18 quest for such an expedited determination is 

19 made by a participant, beneficiary, or enrollee 

20 (or authorized representative) at any time dur21 ing the process for making a determination and 

22 a health care professional certifies, with the re23 quest, that a determination under the proce24 dures described in subparagraph (A) would seri25 ously jeopardize the life or health of the partici-
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1 pant, beneficiary, or enrollee or the ability of 

2 the participant, beneficiary, or enrollee to main3 tain or regain maximum function. Such deter4 mination shall be made in accordance with the 

5 medical exigencies of the case and as soon as 

6 possible, but in no case later than 72 hours 

7 after the time the request is received by the 

8 plan or issuer under this subparagraph. 

9 (C) ONGOING CARE.—

10 (i) CONCURRENT REVIEW.—

11 (I) IN GENERAL.—Subject to 

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

13 review of ongoing care (including hos14 pitalization), which results in a termi15 nation or reduction of such care, the 

16 plan or issuer must provide by tele17 phone and in printed form notice of 

18 the concurrent review determination 

19 to the individual or the individual’s 

20 designee and the individual’s health 

21 care provider in accordance with the 

22 medical exigencies of the case and as 

23 soon as possible, with sufficient time 

24 prior to the termination or reduction 

25 to allow for an appeal under section 
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1 103(b)(3) to be completed before the 

2 termination or reduction takes effect. 

3 (II) CONTENTS OF NOTICE.—

4 Such notice shall include, with respect 

5 to ongoing health care items and serv6 ices, the number of ongoing services 

7 approved, the new total of approved 

8 services, the date of onset of services, 

9 and the next review date, if any, as 

10 well as a statement of the individual’s 

11 rights to further appeal. 

12 (ii) RULE OF CONSTRUCTION.—Clause 

13 (i) shall not be construed as requiring 

14 plans or issuers to provide coverage of care 

15 that would exceed the coverage limitations 

16 for such care. 

17 (2) RETROSPECTIVE DETERMINATION.—A 

18 group health plan, or health insurance issuer offer19 ing health insurance coverage, shall make a retro20 spective determination on a claim for benefits in ac21 cordance with the medical exigencies of the case and 

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

23 the date on which the plan or issuer receives infor24 mation that is reasonably necessary to enable the 

25 plan or issuer to make a determination on the claim, 
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1 or, if earlier, 60 days after the date of receipt of the 

2 claim for benefits. 

3 (c) NOTICE OF A DENIAL OF A CLAIM FOR BENE4 FITS.—Written notice of a denial made under an initial 

5 claim for benefits shall be issued to the participant, bene6 ficiary, or enrollee (or authorized representative) and the 

7 treating health care professional in accordance with the 

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

9 in no case later than 2 days after the date of the deter10 mination (or, in the case described in subparagraph (B) 

11 or (C) of subsection (b)(1), within the 72-hour or applica12 ble period referred to in such subparagraph). 

13 (d) REQUIREMENTS OF NOTICE OF DETERMINA14 TIONS.—The written notice of a denial of a claim for bene15 fits determination under subsection (c) shall be provided 

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

17 understood by the participant, beneficiary, or enrollee and 

18 shall include—

19 (1) the specific reasons for the determination 

20 (including a summary of the clinical or scientific evi21 dence used in making the determination); 

22 (2) the procedures for obtaining additional in23 formation concerning the determination; and
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1 (3) notification of the right to appeal the deter2 mination and instructions on how to initiate an ap3 peal in accordance with section 103. 

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

5 (1) AUTHORIZED REPRESENTATIVE.—The term 

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

7 an individual who is a participant, beneficiary, or en8 rollee, any health care professional or other person 

9 acting on behalf of the individual with the individ10 ual’s consent or without such consent if the indi11 vidual is medically unable to provide such consent. 

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

13 for benefits’’ means any request for coverage (in14 cluding authorization of coverage), for eligibility, or 

15 for payment in whole or in part, for an item or serv16 ice under a group health plan or health insurance 

17 coverage. 

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

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

20 benefits, a denial (in whole or in part) of, or a fail21 ure to act on a timely basis upon, the claim for ben22 efits and includes a failure to provide benefits (in23 cluding items and services) required to be provided 

24 under this title. 
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1 (4) TREATING HEALTH CARE PROFESSIONAL.—

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

3 with respect to services to be provided to a partici4 pant, beneficiary, or enrollee, a health care profes5 sional who is primarily responsible for delivering 

6 those services to the participant, beneficiary, or en7 rollee. 

8 SEC. 103. INTERNAL APPEALS OF CLAIMS DENIALS. 

9 (a) RIGHT TO INTERNAL APPEAL.—

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

11 enrollee (or authorized representative) may appeal 

12 any denial of a claim for benefits under section 102 

13 under the procedures described in this section. 

14 (2) TIME FOR APPEAL.—

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

16 health insurance issuer offering health insur17 ance coverage, shall ensure that a participant, 

18 beneficiary, or enrollee (or authorized represent19 ative) has a period of not less than 180 days 

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

21 benefits under section 102 in which to appeal 

22 such denial under this section. 

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

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

25 be deemed to be the date as of which the partic-
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1 ipant, beneficiary, or enrollee knew of the denial 

2 of the claim for benefits. 

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

4 issuer to issue a determination on a claim for bene5 fits under section 102 within the applicable timeline 

6 established for such a determination under such sec7 tion is a denial of a claim for benefits for purposes 

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

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

10 group health plan, or health insurance issuer offer11 ing health insurance coverage, may waive the inter12 nal review process under this section. In such case 

13 the plan or issuer shall provide notice to the partici14 pant, beneficiary, or enrollee (or authorized rep15 resentative) involved, the participant, beneficiary, or 

16 enrollee (or authorized representative) involved shall 

17 be relieved of any obligation to complete the internal 

18 review involved, and may, at the option of such par19 ticipant, beneficiary, enrollee, or representative pro20 ceed directly to seek further appeal through external 

21 review under section 104 or otherwise. 

22 (b) TIMELINES FOR MAKING DETERMINATIONS.—

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

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

25 that involves an expedited or concurrent determina-
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1 tion, a participant, beneficiary, or enrollee (or au2 thorized representative) may request such appeal 

3 orally. A group health plan, or health insurance 

4 issuer offering health insurance coverage, may re5 quire that the participant, beneficiary, or enrollee 

6 (or authorized representative) provide written con7 firmation of such request in a timely manner on a 

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

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

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

12 of a request for an appeal without regard to whether 

13 and when a written confirmation of such request is 

14 made. 

15 (2) ACCESS TO INFORMATION.—

16 (A) TIMELY PROVISION OF NECESSARY IN17 FORMATION.—With respect to an appeal of a 

18 denial of a claim for benefits, the participant, 

19 beneficiary, or enrollee (or authorized represent20 ative) and the treating health care professional 

21 (if any) shall provide the plan or issuer with ac22 cess to information requested by the plan or 

23 issuer that is necessary to make a determina24 tion relating to the appeal. Such access shall be 

25 provided not later than 5 days after the date on 
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1 which the request for information is received, 

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

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

4 may be necessary to comply with the applicable 

5 timeline under such subparagraph. 

6 (B) LIMITED EFFECT OF FAILURE ON

7 PLAN OR ISSUER’S OBLIGATIONS.—Failure of 

8 the participant, beneficiary, or enrollee to com9 ply with the requirements of subparagraph (A) 

10 shall not remove the obligation of the plan or 

11 issuer to make a decision in accordance with 

12 the medical exigencies of the case and as soon 

13 as possible, based on the available information, 

14 and failure to comply with the time limit estab15 lished by this paragraph shall not remove the 

16 obligation of the plan or issuer to comply with 

17 the requirements of this section. 

18 (3) PRIOR AUTHORIZATION DETERMINA19 TIONS.—

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

21 health insurance issuer offering health insur22 ance coverage, shall make a determination on 

23 an appeal of a denial of a claim for benefits 

24 under this subsection in accordance with the 

25 medical exigencies of the case and as soon as
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1 possible, but in no case later than 14 days from 

2 the date on which the plan or issuer receives 

3 information that is reasonably necessary to en4 able the plan or issuer to make a determination 

5 on the appeal and in no case later than 28 days 

6 after the date the request for the appeal is re7 ceived. 

8 (B) EXPEDITED DETERMINATION.—Not9 withstanding subparagraph (A), a group health 

10 plan, or health insurance issuer offering health 

11 insurance coverage, shall expedite a prior au12 thorization determination on an appeal of a de13 nial of a claim for benefits described in sub14 paragraph (A), when a request for such an ex15 pedited determination is made by a participant, 

16 beneficiary, or enrollee (or authorized represent17 ative) at any time during the process for mak18 ing a determination and a health care profes19 sional certifies, with the request, that a deter20 mination under the procedures described in sub21 paragraph (A) would seriously jeopardize the 

22 life or health of the participant, beneficiary, or 

23 enrollee or the ability of the participant, bene24 ficiary, or enrollee to maintain or regain max25 imum function. Such determination shall be 
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1 made in accordance with the medical exigencies 

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

3 case later than 72 hours after the time the re4 quest for such appeal is received by the plan or 

5 issuer under this subparagraph. 

6 (C) ONGOING CARE DETERMINATIONS.—

7 (i) IN GENERAL.—Subject to clause 

8 (ii), in the case of a concurrent review de9 termination described in section 

10 102(b)(1)(C)(i)(I), which results in a ter11 mination or reduction of such care, the 

12 plan or issuer must provide notice of the 

13 determination on the appeal under this 

14 section by telephone and in printed form to 

15 the individual or the individual’s designee 

16 and the individual’s health care provider in 

17 accordance with the medical exigencies of 

18 the case and as soon as possible, with suf19 ficient time prior to the termination or re20 duction to allow for an external appeal 

21 under section 104 to be completed before 

22 the termination or reduction takes effect. 

23 (ii) RULE OF CONSTRUCTION.—Clause 

24 (i) shall not be construed as requiring 

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

2 for such care. 

3 (4) RETROSPECTIVE DETERMINATION.—A 

4 group health plan, or health insurance issuer offer5 ing health insurance coverage, shall make a retro6 spective determination on an appeal of a claim for 

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

8 on which the plan or issuer receives necessary infor9 mation that is reasonably necessary to enable the 

10 plan or issuer to make a determination on the ap11 peal and in no case later than 60 days after the date 

12 the request for the appeal is received. 

13 (c) CONDUCT OF REVIEW.—

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

15 claim for benefits under this section shall be con16 ducted by an individual with appropriate expertise 

17 who was not involved in the initial determination. 

18 (2) PEER REVIEW OF MEDICAL DECISIONS BY

19 HEALTH CARE PROFESSIONALS.—A review of an ap20 peal of a denial of a claim for benefits that is based 

21 on a lack of medical necessity and appropriateness, 

22 or based on an experimental or investigational treat23 ment, or requires an evaluation of medical facts—

24 (A) shall be made by a physician 

25 (allopathic or osteopathic); or 
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1 (B) in a claim for benefits provided by a 

2 non-physician health professional, shall be made 

3 by reviewer (or reviewers) including at least one 

4 practicing non-physician health professional of 

5 the same or similar specialty; 

6 with appropriate expertise (including, in the case of 

7 a child, appropriate pediatric expertise) and acting 

8 within the appropriate scope of practice within the 

9 State in which the service is provided or rendered, 

10 who was not involved in the initial determination. 

11 (d) NOTICE OF DETERMINATION.—

12 (1) IN GENERAL.—Written notice of a deter13 mination made under an internal appeal of a denial 

14 of a claim for benefits shall be issued to the partici15 pant, beneficiary, or enrollee (or authorized rep16 resentative) and the treating health care professional 

17 in accordance with the medical exigencies of the case 

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

19 2 days after the date of completion of the review (or, 

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

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

22 period referred to in such subparagraph). 

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

24 plan or issuer under this section shall be treated as 

25 the final determination of the plan or issuer on a de-
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1 nial of a claim for benefits. The failure of a plan or 

2 issuer to issue a determination on an appeal of a de3 nial of a claim for benefits under this section within 

4 the applicable timeline established for such a deter5 mination shall be treated as a final determination on 

6 an appeal of a denial of a claim for benefits for pur7 poses of proceeding to external review under section 

8 104. 

9 (3) REQUIREMENTS OF NOTICE.—With respect 

10 to a determination made under this section, the no11 tice described in paragraph (1) shall be provided in 

12 printed form and written in a manner calculated to 

13 be understood by the participant, beneficiary, or en14 rollee and shall include— 

15 (A) the specific reasons for the determina16 tion (including a summary of the clinical or sci17 entific evidence used in making the determina18 tion); 

19 (B) the procedures for obtaining additional 

20 information concerning the determination; and 

21 (C) notification of the right to an inde22 pendent external review under section 104 and 

23 instructions on how to initiate such a review.
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1 SEC. 104. INDEPENDENT EXTERNAL APPEALS PROCE2 DURES. 

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

4 plan, and a health insurance issuer offering health insur5 ance coverage, shall provide in accordance with this sec6 tion participants, beneficiaries, and enrollees (or author7 ized representatives) with access to an independent exter8 nal review for any denial of a claim for benefits. 

9 (b) INITIATION OF THE INDEPENDENT EXTERNAL

10 REVIEW PROCESS.—

11 (1) TIME TO FILE.—A request for an inde12 pendent external review under this section shall be 

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

14 after the date on which the participant, beneficiary, 

15 or enrollee receives notice of the denial under section 

16 103(d) or notice of waiver of internal review under 

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

18 issuer has failed to make a timely decision under 

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

20 beneficiary that it has failed to make a timely deci21 sion and that the beneficiary must file an appeal 

22 with an external review entity within 180 days if the 

23 participant or beneficiary desires to file such an ap24 peal. 

25 (2) FILING OF REQUEST.—
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1 (A) IN GENERAL.—Subject to the suc2 ceeding provisions of this subsection, a group 

3 health plan, and a health insurance issuer offer4 ing health insurance coverage, may—

5 (i) except as provided in subparagraph 

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

7 in writing; 

8 (ii) limit the filing of such a request 

9 to the participant, beneficiary, or enrollee 

10 involved (or an authorized representative); 

11 (iii) except if waived by the plan or 

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

13 access to an independent external review 

14 under this section upon a final determina15 tion of a denial of a claim for benefits 

16 under the internal review procedure under 

17 section 103; 

18 (iv) except as provided in subpara19 graph (B)(ii), require payment of a filing 

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

21 not exceed $25; and 

22 (v) require that a request for review 

23 include the consent of the participant, ben24 eficiary, or enrollee (or authorized rep25 resentative) for the release of necessary 
27

•S 2083 IS 

1 medical information or records of the par2 ticipant, beneficiary, or enrollee to the 

3 qualified external review entity only for 

4 purposes of conducting external review ac5 tivities. 

6 (B) REQUIREMENTS AND EXCEPTION RE7 LATING TO GENERAL RULE.—

8 (i) ORAL REQUESTS PERMITTED IN

9 EXPEDITED OR CONCURRENT CASES.—In 

10 the case of an expedited or concurrent ex11 ternal review as provided for under sub12 section (e), the request may be made oral13 ly. A group health plan, or health insur14 ance issuer offering health insurance cov15 erage, may require that the participant, 

16 beneficiary, or enrollee (or authorized rep17 resentative) provide written confirmation 

18 of such request in a timely manner on a 

19 form provided by the plan or issuer. Such 

20 written confirmation shall be treated as a 

21 consent for purposes of subparagraph 

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

23 for such a review, the making of the re24 quest (and the timing of such request) 

25 shall be treated as the making at that time 
28

•S 2083 IS 

1 of a request for such an external review 

2 without regard to whether and when a 

3 written confirmation of such request is 

4 made. 

5 (ii) EXCEPTION TO FILING FEE RE6 QUIREMENT.—

7 (I) INDIGENCY.—Payment of a 

8 filing fee shall not be required under 

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

10 certification (in a form and manner 

11 specified in guidelines established by 

12 the appropriate Secretary) that the 

13 participant, beneficiary, or enrollee is 

14 indigent (as defined in such guide15 lines). 

16 (II) FEE NOT REQUIRED.—Pay17 ment of a filing fee shall not be re18 quired under subparagraph (A)(iv) if 

19 the plan or issuer waives the internal 

20 appeals process under section 

21 103(a)(4). 

22 (III) REFUNDING OF FEE.—The 

23 filing fee paid under subparagraph 

24 (A)(iv) shall be refunded if the deter25 mination under the independent exter-
29

•S 2083 IS 

1 nal review is to reverse or modify the 

2 denial which is the subject of the re3 view. 

4 (IV) COLLECTION OF FILING

5 FEE.—The failure to pay such a filing 

6 fee shall not prevent the consideration 

7 of a request for review but, subject to 

8 the preceding provisions of this clause, 

9 shall constitute a legal liability to pay. 

10 (c) REFERRAL TO QUALIFIED EXTERNAL REVIEW

11 ENTITY UPON REQUEST.—

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

13 for independent external review with the group 

14 health plan, or health insurance issuer offering 

15 health insurance coverage, the plan or issuer shall 

16 immediately refer such request, and forward the 

17 plan or issuer’s initial decision (including the infor18 mation described in section 103(d)(3)(A)), to a 

19 qualified external review entity selected in accord20 ance with this section. 

21 (2) ACCESS TO PLAN OR ISSUER AND HEALTH

22 PROFESSIONAL INFORMATION.—With respect to an 

23 independent external review conducted under this 

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

25 authorized representative), the plan or issuer, and
30

•S 2083 IS 

1 the treating health care professional (if any) shall 

2 provide the external review entity with information 

3 that is necessary to conduct a review under this sec4 tion, as determined and requested by the entity. 

5 Such information shall be provided not later than 

6 5 days after the date on which the request for infor7 mation is received, or, in a case described in clause 

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

9 time as may be necessary to comply with the appli10 cable timeline under such clause. 

11 (3) SCREENING OF REQUESTS BY QUALIFIED

12 EXTERNAL REVIEW ENTITIES.—

13 (A) IN GENERAL.—With respect to a re14 quest referred to a qualified external review en15 tity under paragraph (1) relating to a denial of 

16 a claim for benefits, the entity shall refer such 

17 request for the conduct of an independent med18 ical review unless the entity determines that—

19 (i) any of the conditions described in 

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

21 have not been met; 

22 (ii) the denial of the claim for benefits 

23 does not involve a medically reviewable de24 cision under subsection (d)(2); 
31

•S 2083 IS 

1 (iii) the denial of the claim for bene2 fits relates to a decision regarding whether 

3 an individual is a participant, beneficiary, 

4 or enrollee who is enrolled under the terms 

5 and conditions of the plan or coverage (in6 cluding the applicability of any waiting pe7 riod under the plan or coverage); or 

8 (iv) the denial of the claim for bene9 fits is a decision as to the application of 

10 cost-sharing requirements or the applica11 tion of a specific exclusion or express limi12 tation on the amount, duration, or scope of 

13 coverage of items or services under the 

14 terms and conditions of the plan or cov15 erage unless the decision is a denial de16 scribed in subsection (d)(2). 

17 Upon making a determination that any of 

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

19 the request, the entity shall determine that the 

20 denial of a claim for benefits involved is not eli21 gible for independent medical review under sub22 section (d), and shall provide notice in accord23 ance with subparagraph (C). 

24 (B) PROCESS FOR MAKING DETERMINA25 TIONS.—
32

•S 2083 IS 

1 (i) NO DEFERENCE TO PRIOR DETER2 MINATIONS.—In making determinations 

3 under subparagraph (A), there shall be no 

4 deference given to determinations made by 

5 the plan or issuer or the recommendation 

6 of a treating health care professional (if 

7 any). 

8 (ii) USE OF APPROPRIATE PER9 SONNEL.—A qualified external review enti10 ty shall use appropriately qualified per11 sonnel to make determinations under this 

12 section. 

13 (C) NOTICES AND GENERAL TIMELINES

14 FOR DETERMINATION.—

15 (i) NOTICE IN CASE OF DENIAL OF

16 REFERRAL.—If the entity under this para17 graph does not make a referral to an inde18 pendent medical reviewer, the entity shall 

19 provide notice to the plan or issuer, the 

20 participant, beneficiary, or enrollee (or au21 thorized representative) filing the request, 

22 and the treating health care professional 

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

24 independent medical review. Such notice—
33

•S 2083 IS 

1 (I) shall be written (and, in addi2 tion, may be provided orally) in a 

3 manner calculated to be understood 

4 by a participant or enrollee; 

5 (II) shall include the reasons for 

6 the determination; 

7 (III) include any relevant terms 

8 and conditions of the plan or cov9 erage; and 

10 (IV) include a description of any 

11 further recourse available to the indi12 vidual. 

13 (ii) GENERAL TIMELINE FOR DETER14 MINATIONS.—Upon receipt of information 

15 under paragraph (2), the qualified external 

16 review entity, and if required the inde17 pendent medical reviewer, shall make a de18 termination within the overall timeline that 

19 is applicable to the case under review as 

20 described in subsection (e), except that if 

21 the entity determines that a referral to an 

22 independent medical reviewer is not re23 quired, the entity shall provide notice of 

24 such determination to the participant, ben25 eficiary, or enrollee (or authorized rep-
34

•S 2083 IS 

1 resentative) within such timeline and with2 in 2 days of the date of such determina3 tion. 

4 (d) INDEPENDENT MEDICAL REVIEW.—

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

6 entity determines under subsection (c) that a denial 

7 of a claim for benefits is eligible for independent 

8 medical review, the entity shall refer the denial in9 volved to an independent medical reviewer for the 

10 conduct of an independent medical review under this 

11 subsection. 

12 (2) MEDICALLY REVIEWABLE DECISIONS.—A 

13 denial of a claim for benefits is eligible for inde14 pendent medical review if the benefit for the item or 

15 service for which the claim is made would be a cov16 ered benefit under the terms and conditions of the 

17 plan or coverage but for one (or more) of the fol18 lowing determinations: 

19 (A) DENIALS BASED ON MEDICAL NECES20 SITY AND APPROPRIATENESS.—A determination 

21 that the item or service is not covered because 

22 it is not medically necessary and appropriate or 

23 based on the application of substantially equiva24 lent terms.
35

•S 2083 IS 

1 (B) DENIALS BASED ON EXPERIMENTAL

2 OR INVESTIGATIONAL TREATMENT.—A deter3 mination that the item or service is not covered 

4 because it is experimental or investigational or 

5 based on the application of substantially equiva6 lent terms. 

7 (C) DENIALS OTHERWISE BASED ON AN

8 EVALUATION OF MEDICAL FACTS.—A deter9 mination that the item or service or condition 

10 is not covered based on grounds that require an 

11 evaluation of the medical facts by a health care 

12 professional in the specific case involved to de13 termine the coverage and extent of coverage of 

14 the item or service or condition. 

15 (3) INDEPENDENT MEDICAL REVIEW DETER16 MINATION.—

17 (A) IN GENERAL.—An independent med18 ical reviewer under this section shall make a 

19 new independent determination with respect to 

20 whether or not the denial of a claim for a ben21 efit that is the subject of the review should be 

22 upheld, reversed, or modified. 

23 (B) STANDARD FOR DETERMINATION.—

24 The independent medical reviewer’s determina25 tion relating to the medical necessity and ap-
36

•S 2083 IS 

1 propriateness, or the experimental or investiga2 tion nature, or the evaluation of the medical 

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

4 based on the medical condition of the partici5 pant, beneficiary, or enrollee (including the 

6 medical records of the participant, beneficiary, 

7 or enrollee) and valid, relevant scientific evi8 dence and clinical evidence, including peer-re9 viewed medical literature or findings and in10 cluding expert opinion. 

11 (C) NO COVERAGE FOR EXCLUDED BENE12 FITS.—Nothing in this subsection shall be con13 strued to permit an independent medical re14 viewer to require that a group health plan, or 

15 health insurance issuer offering health insur16 ance coverage, provide coverage for items or 

17 services for which benefits are specifically ex18 cluded or expressly limited under the plan or 

19 coverage in the plain language of the plan docu20 ment (and which are disclosed under section 

21 121(b)(1)(C)). Notwithstanding any other pro22 vision of this Act, any exclusion of an exact 

23 medical procedure, any exact time limit on the 

24 duration or frequency of coverage, and any 

25 exact dollar limit on the amount of coverage 
37

•S 2083 IS 

1 that is specifically enumerated and defined (in 

2 the plain language of the plan or coverage docu3 ments) under the plan or coverage offered by a 

4 group health plan or health insurance issuer of5 fering health insurance coverage and that is 

6 disclosed under section 121(b)(1) shall be con7 sidered to govern the scope of the benefits that 

8 may be required: Provided, That the terms and 

9 conditions of the plan or coverage relating to 

10 such an exclusion or limit are in compliance 

11 with the requirements of law. 

12 (D) EVIDENCE AND INFORMATION TO BE

13 USED IN MEDICAL REVIEWS.—In making a de14 termination under this subsection, the inde15 pendent medical reviewer shall also consider ap16 propriate and available evidence and informa17 tion, including the following: 

18 (i) The determination made by the 

19 plan or issuer with respect to the claim 

20 upon internal review and the evidence, 

21 guidelines, or rationale used by the plan or 

22 issuer in reaching such determination. 

23 (ii) The recommendation of the treat24 ing health care professional and the evi25 dence, guidelines, and rationale used by
38

•S 2083 IS 

1 the treating health care professional in 

2 reaching such recommendation. 

3 (iii) Additional relevant evidence or 

4 information obtained by the reviewer or 

5 submitted by the plan, issuer, participant, 

6 beneficiary, or enrollee (or an authorized 

7 representative), or treating health care 

8 professional. 

9 (iv) The plan or coverage document. 

10 (E) INDEPENDENT DETERMINATION.—In 

11 making determinations under this subtitle, a 

12 qualified external review entity and an inde13 pendent medical reviewer shall—

14 (i) consider the claim under review 

15 without deference to the determinations 

16 made by the plan or issuer or the rec17 ommendation of the treating health care 

18 professional (if any); and 

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

20 definition used by the plan or issuer of 

21 ‘‘medically necessary and appropriate’’, or 

22 ‘‘experimental or investigational’’, or other 

23 substantially equivalent terms that are 

24 used by the plan or issuer to describe med25 ical necessity and appropriateness or ex-
39

•S 2083 IS 

1 perimental or investigational nature of the 

2 treatment. 

3 (F) DETERMINATION OF INDEPENDENT

4 MEDICAL REVIEWER.—An independent medical 

5 reviewer shall, in accordance with the deadlines 

6 described in subsection (e), prepare a written 

7 determination to uphold, reverse, or modify the 

8 denial under review. Such written determination 

9 shall include—

10 (i) the determination of the reviewer; 

11 (ii) the specific reasons of the re12 viewer for such determination, including a 

13 summary of the clinical or scientific evi14 dence used in making the determination; 

15 and 

16 (iii) with respect to a determination to 

17 reverse or modify the denial under review, 

18 a timeframe within which the plan or 

19 issuer must comply with such determina20 tion. 

21 (G) NONBINDING NATURE OF ADDITIONAL

22 RECOMMENDATIONS.—In addition to the deter23 mination under subparagraph (F), the reviewer 

24 may provide the plan or issuer and the treating 

25 health care professional with additional rec-
40

•S 2083 IS 

1 ommendations in connection with such a deter2 mination, but any such recommendations shall 

3 not affect (or be treated as part of) the deter4 mination and shall not be binding on the plan 

5 or issuer. 

6 (e) TIMELINES AND NOTIFICATIONS.—

7 (1) TIMELINES FOR INDEPENDENT MEDICAL

8 REVIEW.—

9 (A) PRIOR AUTHORIZATION DETERMINA10 TION.—

11 (i) IN GENERAL.—The independent 

12 medical reviewer (or reviewers) shall make 

13 a determination on a denial of a claim for 

14 benefits that is referred to the reviewer 

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

16 the medical exigencies of the case and as 

17 soon as possible, but in no case later than 

18 14 days after the date of receipt of infor19 mation under subsection (c)(2) if the re20 view involves a prior authorization of items 

21 or services and in no case later than 21 

22 days after the date the request for external 

23 review is received. 

24 (ii) EXPEDITED DETERMINATION.—

25 Notwithstanding clause (i) and subject to 
41

•S 2083 IS 

1 clause (iii), the independent medical re2 viewer (or reviewers) shall make an expe3 dited determination on a denial of a claim 

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

5 request for such an expedited determina6 tion is made by a participant, beneficiary, 

7 or enrollee (or authorized representative) 

8 at any time during the process for making 

9 a determination, and a health care profes10 sional certifies, with the request, that a de11 termination under the timeline described in 

12 clause (i) would seriously jeopardize the 

13 life or health of the participant, bene14 ficiary, or enrollee or the ability of the par15 ticipant, beneficiary, or enrollee to main16 tain or regain maximum function. Such de17 termination shall be made as soon in ac18 cordance with the medical exigencies of the 

19 case and as soon as possible, but in no 

20 case later than 72 hours after the time the 

21 request for external review is received by 

22 the qualified external review entity. 

23 (iii) ONGOING CARE DETERMINA24 TION.—Notwithstanding clause (i), in the 

25 case of a review described in such sub-
42

•S 2083 IS 

1 clause that involves a termination or reduc2 tion of care, the notice of the determina3 tion shall be completed not later than 24 

4 hours after the time the request for exter5 nal review is received by the qualified ex6 ternal review entity and before the end of 

7 the approved period of care. 

8 (B) RETROSPECTIVE DETERMINATION.—

9 The independent medical reviewer (or review10 ers) shall complete a review in the case of a ret11 rospective determination on an appeal of a de12 nial of a claim for benefits that is referred to 

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

14 later than 30 days after the date of receipt of 

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

16 case later than 60 days after the date the re17 quest for external review is received by the 

18 qualified external review entity. 

19 (2) NOTIFICATION OF DETERMINATION.—The 

20 external review entity shall ensure that the plan or 

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

22 authorized representative) and the treating health 

23 care professional (if any) receives a copy of the writ24 ten determination of the independent medical re25 viewer prepared under subsection (d)(3)(F). Nothing
43

•S 2083 IS 

1 in this paragraph shall be construed as preventing 

2 an entity or reviewer from providing an initial oral 

3 notice of the reviewer’s determination. 

4 (3) FORM OF NOTICES.—Determinations and 

5 notices under this subsection shall be written in a 

6 manner calculated to be understood by a participant. 

7 (f) COMPLIANCE.—

8 (1) APPLICATION OF DETERMINATIONS.—

9 (A) EXTERNAL REVIEW DETERMINATIONS

10 BINDING ON PLAN.—The determinations of an 

11 external review entity and an independent med12 ical reviewer under this section shall be binding 

13 upon the plan or issuer involved. 

14 (B) COMPLIANCE WITH DETERMINA15 TION.—If the determination of an independent 

16 medical reviewer is to reverse or modify the de17 nial, the plan or issuer, upon the receipt of such 

18 determination, shall authorize coverage to com19 ply with the medical reviewer’s determination in 

20 accordance with the timeframe established by 

21 the medical reviewer. 

22 (2) FAILURE TO COMPLY.—

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

24 to comply with the timeframe established under 

25 paragraph (1)(B) with respect to a participant, 
44

•S 2083 IS 

1 beneficiary, or enrollee, where such failure to 

2 comply is caused by the plan or issuer, the par3 ticipant, beneficiary, or enrollee may obtain the 

4 items or services involved (in a manner con5 sistent with the determination of the inde6 pendent external reviewer) from any provider 

7 regardless of whether such provider is a partici8 pating provider under the plan or coverage. 

9 (B) REIMBURSEMENT.—

10 (i) IN GENERAL.—Where a partici11 pant, beneficiary, or enrollee obtains items 

12 or services in accordance with subpara13 graph (A), the plan or issuer involved shall 

14 provide for reimbursement of the costs of 

15 such items or services. Such reimburse16 ment shall be made to the treating health 

17 care professional or to the participant, ben18 eficiary, or enrollee (in the case of a partic19 ipant, beneficiary, or enrollee who pays for 

20 the costs of such items or services). 

21 (ii) AMOUNT.—The plan or issuer 

22 shall fully reimburse a professional, partici23 pant, beneficiary, or enrollee under clause 

24 (i) for the total costs of the items or serv25 ices provided (regardless of any plan limi-
45

•S 2083 IS 

1 tations that may apply to the coverage of 

2 such items or services) so long as the items 

3 or services were provided in a manner con4 sistent with the determination of the inde5 pendent medical reviewer. 

6 (C) FAILURE TO REIMBURSE.—Where a 

7 plan or issuer fails to provide reimbursement to 

8 a professional, participant, beneficiary, or en9 rollee in accordance with this paragraph, the 

10 professional, participant, beneficiary, or enrollee 

11 may commence a civil action (or utilize other 

12 remedies available under law) to recover only 

13 the amount of any such reimbursement that is 

14 owed by the plan or issuer and any necessary 

15 legal costs or expenses (including attorney’s 

16 fees) incurred in recovering such reimburse17 ment. 

18 (D) AVAILABLE REMEDIES.—The remedies 

19 provided under this paragraph are in addition 

20 to any other available remedies. 

21 (3) PENALTIES AGAINST AUTHORIZED OFFI22 CIALS FOR REFUSING TO AUTHORIZE THE DETER23 MINATION OF AN EXTERNAL REVIEW ENTITY.—

24 (A) MONETARY PENALTIES.—
46

•S 2083 IS 

1 (i) IN GENERAL.—In any case in 

2 which the determination of an external re3 view entity is not followed by a group 

4 health plan, or by a health insurance issuer 

5 offering health insurance coverage, any 

6 person who, acting in the capacity of au7 thorizing the benefit, causes such refusal 

8 may, in the discretion in a court of com9 petent jurisdiction, be liable to an ag10 grieved participant, beneficiary, or enrollee 

11 for a civil penalty in an amount of up to 

12 $1,000 a day from the date on which the 

13 determination was transmitted to the plan 

14 or issuer by the external review entity until 

15 the date the refusal to provide the benefit 

16 is corrected. 

17 (ii) ADDITIONAL PENALTY FOR FAIL18 ING TO FOLLOW TIMELINE.—In any case 

19 in which treatment was not commenced by 

20 the plan in accordance with the determina21 tion of an independent external reviewer, 

22 the Secretary shall assess a civil penalty of 

23 $10,000 against the plan and the plan 

24 shall pay such penalty to the participant, 

25 beneficiary, or enrollee involved. 
47

•S 2083 IS 

1 (B) CEASE AND DESIST ORDER AND

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

3 described in subparagraph (A) brought by a 

4 participant, beneficiary, or enrollee with respect 

5 to a group health plan, or a health insurance 

6 issuer offering health insurance coverage, in 

7 which a plaintiff alleges that a person referred 

8 to in such subparagraph has taken an action re9 sulting in a refusal of a benefit determined by 

10 an external appeal entity to be covered, or has 

11 failed to take an action for which such person 

12 is responsible under the terms and conditions of 

13 the plan or coverage and which is necessary 

14 under the plan or coverage for authorizing a 

15 benefit, the court shall cause to be served on 

16 the defendant an order requiring the defend17 ant—

18 (i) to cease and desist from the al19 leged action or failure to act; and 

20 (ii) to pay to the plaintiff a reasonable 

21 attorney’s fee and other reasonable costs 

22 relating to the prosecution of the action on 

23 the charges on which the plaintiff prevails. 

24 (C) ADDITIONAL CIVIL PENALTIES.—
48

•S 2083 IS 

1 (i) IN GENERAL.—In addition to any 

2 penalty imposed under subparagraph (A) 

3 or (B), the appropriate Secretary may as4 sess a civil penalty against a person acting 

5 in the capacity of authorizing a benefit de6 termined by an external review entity for 

7 one or more group health plans, or health 

8 insurance issuers offering health insurance 

9 coverage, for—

10 (I) any pattern or practice of re11 peated refusal to authorize a benefit 

12 determined by an external appeal enti13 ty to be covered; or 

14 (II) any pattern or practice of re15 peated violations of the requirements 

16 of this section with respect to such 

17 plan or coverage. 

18 (ii) STANDARD OF PROOF AND

19 AMOUNT OF PENALTY.—Such penalty shall 

20 be payable only upon proof by clear and 

21 convincing evidence of such pattern or 

22 practice and shall be in an amount not to 

23 exceed the lesser of—

24 (I) 25 percent of the aggregate 

25 value of benefits shown by the appro-
49

•S 2083 IS 

1 priate Secretary to have not been pro2 vided, or unlawfully delayed, in viola3 tion of this section under such pattern 

4 or practice; or 

5 (II) $500,000. 

6 (D) REMOVAL AND DISQUALIFICATION.—

7 Any person acting in the capacity of author8 izing benefits who has engaged in any such pat9 tern or practice described in subparagraph 

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

11 the petition of the appropriate Secretary, may 

12 be removed by the court from such position, 

13 and from any other involvement, with respect to 

14 such a plan or coverage, and may be precluded 

15 from returning to any such position or involve16 ment for a period determined by the court. 

17 (4) PROTECTION OF LEGAL RIGHTS.—Nothing 

18 in this subsection or subtitle shall be construed as 

19 altering or eliminating any cause of action or legal 

20 rights or remedies of participants, beneficiaries, en21 rollees, and others under State or Federal law (in22 cluding sections 502 and 503 of the Employee Re23 tirement Income Security Act of 1974), including 

24 the right to file judicial actions to enforce rights. 
50

•S 2083 IS 

1 (g) QUALIFICATIONS OF INDEPENDENT MEDICAL

2 REVIEWERS.—

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

4 more individuals to conduct independent medical re5 view under subsection (c), the qualified external re6 view entity shall ensure that—

7 (A) each independent medical reviewer 

8 meets the qualifications described in paragraphs 

9 (2) and (3); 

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

11 such reviewer meets the requirements described 

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

13 (C) compensation provided by the entity to 

14 the reviewer is consistent with paragraph (6). 

15 (2) LICENSURE AND EXPERTISE.—Each inde16 pendent medical reviewer shall be a physician 

17 (allopathic or osteopathic) or health care profes18 sional who—

19 (A) is appropriately credentialed or li20 censed in 1 or more States to deliver health 

21 care services; and 

22 (B) typically treats the condition, makes 

23 the diagnosis, or provides the type of treatment 

24 under review. 

25 (3) INDEPENDENCE.—
51

•S 2083 IS 

1 (A) IN GENERAL.—Subject to subpara2 graph (B), each independent medical reviewer 

3 in a case shall—

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

5 in paragraph (7)); 

6 (ii) not have a material familial, fi7 nancial, or professional relationship with 

8 such a party; and 

9 (iii) not otherwise have a conflict of 

10 interest with such a party (as determined 

11 under regulations). 

12 (B) EXCEPTION.—Nothing in subpara13 graph (A) shall be construed to—

14 (i) prohibit an individual, solely on the 

15 basis of affiliation with the plan or issuer, 

16 from serving as an independent medical re17 viewer if—

18 (I) a non-affiliated individual is 

19 not reasonably available; 

20 (II) the affiliated individual is 

21 not involved in the provision of items 

22 or services in the case under review; 

23 (III) the fact of such an affili24 ation is disclosed to the plan or issuer 

25 and the participant, beneficiary, or 
52

•S 2083 IS 

1 enrollee (or authorized representative) 

2 and neither party objects; and 

3 (IV) the affiliated individual is 

4 not an employee of the plan or issuer 

5 and does not provide services exclu6 sively or primarily to or on behalf of 

7 the plan or issuer; 

8 (ii) prohibit an individual who has 

9 staff privileges at the institution where the 

10 treatment involved takes place from serv11 ing as an independent medical reviewer 

12 merely on the basis of such affiliation if 

13 the affiliation is disclosed to the plan or 

14 issuer and the participant, beneficiary, or 

15 enrollee (or authorized representative), and 

16 neither party objects; or 

17 (iii) prohibit receipt of compensation 

18 by an independent medical reviewer from 

19 an entity if the compensation is provided 

20 consistent with paragraph (6). 

21 (4) PRACTICING HEALTH CARE PROFESSIONAL

22 IN SAME FIELD.—

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

24 treatment, or the provision of items or serv25 ices—
53

•S 2083 IS 

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

2 a practicing physician (allopathic or osteo3 pathic) of the same or similar specialty, as 

4 a physician who, acting within the appro5 priate scope of practice within the State in 

6 which the service is provided or rendered, 

7 typically treats the condition, makes the 

8 diagnosis, or provides the type of treat9 ment under review; or 

10 (ii) by a non-physician health care 

11 professional, a reviewer (or reviewers) shall 

12 include at least one practicing non-physi13 cian health care professional of the same 

14 or similar specialty as the non-physician 

15 health care professional who, acting within 

16 the appropriate scope of practice within 

17 the State in which the service is provided 

18 or rendered, typically treats the condition, 

19 makes the diagnosis, or provides the type 

20 of treatment under review. 

21 (B) PRACTICING DEFINED.—For purposes 

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

23 with respect to an individual who is a physician 

24 or other health care professional that the indi-
54

•S 2083 IS 

1 vidual provides health care services to individual 

2 patients on average at least 2 days per week. 

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

4 external review relating to a child, a reviewer shall 

5 have expertise under paragraph (2) in pediatrics. 

6 (6) LIMITATIONS ON REVIEWER COMPENSA7 TION.—Compensation provided by a qualified exter8 nal review entity to an independent medical reviewer 

9 in connection with a review under this section 

10 shall—

11 (A) not exceed a reasonable level; and 

12 (B) not be contingent on the decision ren13 dered by the reviewer. 

14 (7) RELATED PARTY DEFINED.—For purposes 

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

16 respect to a denial of a claim under a plan or cov17 erage relating to a participant, beneficiary, or en18 rollee, any of the following: 

19 (A) The plan, plan sponsor, or issuer in20 volved, or any fiduciary, officer, director, or em21 ployee of such plan, plan sponsor, or issuer. 

22 (B) The participant, beneficiary, or en23 rollee (or authorized representative). 
55

•S 2083 IS 

1 (C) The health care professional that pro2 vides the items or services involved in the de3 nial. 

4 (D) The institution at which the items or 

5 services (or treatment) involved in the denial 

6 are provided. 

7 (E) The manufacturer of any drug or 

8 other item that is included in the items or serv9 ices involved in the denial. 

10 (F) Any other party determined under any 

11 regulations to have a substantial interest in the 

12 denial involved. 

13 (h) QUALIFIED EXTERNAL REVIEW ENTITIES.—

14 (1) SELECTION OF QUALIFIED EXTERNAL RE15 VIEW ENTITIES.—

16 (A) LIMITATION ON PLAN OR ISSUER SE17 LECTION.—The appropriate Secretary shall im18 plement procedures—

19 (i) to assure that the selection process 

20 among qualified external review entities 

21 will not create any incentives for external 

22 review entities to make a decision in a bi23 ased manner; and 
56

•S 2083 IS 

1 (ii) for auditing a sample of decisions 

2 by such entities to assure that no such de3 cisions are made in a biased manner. 

4 No such selection process under the procedures 

5 implemented by the appropriate Secretary may 

6 give either the patient or the plan or issuer any 

7 ability to determine or influence the selection of 

8 a qualified external review entity to review the 

9 case of any participant, beneficiary, or enrollee. 

10 (B) STATE AUTHORITY WITH RESPECT TO

11 QUALIFIED EXTERNAL REVIEW ENTITIES FOR

12 HEALTH INSURANCE ISSUERS.—With respect to 

13 health insurance issuers offering health insur14 ance coverage in a State, the State may provide 

15 for external review activities to be conducted by 

16 a qualified external appeal entity that is des17 ignated by the State or that is selected by the 

18 State in a manner determined by the State to 

19 assure an unbiased determination. 

20 (2) CONTRACT WITH QUALIFIED EXTERNAL RE21 VIEW ENTITY.—Except as provided in paragraph 

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

23 issuer under this section shall be conducted under a 

24 contract between the plan or issuer and 1 or more 
57

•S 2083 IS 

1 qualified external review entities (as defined in para2 graph (4)(A)). 

3 (3) TERMS AND CONDITIONS OF CONTRACT.—

4 The terms and conditions of a contract under para5 graph (2) shall—

6 (A) be consistent with the standards the 

7 appropriate Secretary shall establish to assure 

8 there is no real or apparent conflict of interest 

9 in the conduct of external review activities; and 

10 (B) provide that the costs of the external 

11 review process shall be borne by the plan or 

12 issuer. 

13 Subparagraph (B) shall not be construed as apply14 ing to the imposition of a filing fee under subsection 

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

16 beneficiary, or enrollee (or authorized representative) 

17 or treating health care professional (if any) in sup18 port of the review, including the provision of addi19 tional evidence or information. 

20 (4) QUALIFICATIONS.—

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

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

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

24 initially certified (and periodically recertified)
58

•S 2083 IS 

1 under subparagraph (C) as meeting the fol2 lowing requirements: 

3 (i) The entity has (directly or through 

4 contracts or other arrangements) sufficient 

5 medical, legal, and other expertise and suf6 ficient staffing to carry out duties of a 

7 qualified external review entity under this 

8 section on a timely basis, including making 

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

10 and providing for independent medical re11 views under subsection (d). 

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

13 or an affiliate or a subsidiary of a plan or 

14 issuer, and is not an affiliate or subsidiary 

15 of a professional or trade association of 

16 plans or issuers or of health care providers. 

17 (iii) The entity has provided assur18 ances that it will conduct external review 

19 activities consistent with the applicable re20 quirements of this section and standards 

21 specified in subparagraph (C), including 

22 that it will not conduct any external review 

23 activities in a case unless the independence 

24 requirements of subparagraph (B) are met 

25 with respect to the case. 
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•S 2083 IS 

1 (iv) The entity has provided assur2 ances that it will provide information in a 

3 timely manner under subparagraph (D). 

4 (v) The entity meets such other re5 quirements as the appropriate Secretary 

6 provides by regulation. 

7 (B) INDEPENDENCE REQUIREMENTS.—

8 (i) IN GENERAL.—Subject to clause 

9 (ii), an entity meets the independence re10 quirements of this subparagraph with re11 spect to any case if the entity—

12 (I) is not a related party (as de13 fined in subsection (g)(7)); 

14 (II) does not have a material fa15 milial, financial, or professional rela16 tionship with such a party; and 

17 (III) does not otherwise have a 

18 conflict of interest with such a party 

19 (as determined under regulations). 

20 (ii) EXCEPTION FOR REASONABLE

21 COMPENSATION.—Nothing in clause (i) 

22 shall be construed to prohibit receipt by a 

23 qualified external review entity of com24 pensation from a plan or issuer for the 

25 conduct of external review activities under 
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•S 2083 IS 

1 this section if the compensation is provided 

2 consistent with clause (iii). 

3 (iii) LIMITATIONS ON ENTITY COM4 PENSATION.—Compensation provided by a 

5 plan or issuer to a qualified external review 

6 entity in connection with reviews under 

7 this section shall—

8 (I) not exceed a reasonable level; 

9 and 

10 (II) not be contingent on any de11 cision rendered by the entity or by 

12 any independent medical reviewer. 

13 (C) CERTIFICATION AND RECERTIFICATION

14 PROCESS.—

15 (i) IN GENERAL.—The initial certifi16 cation and recertification of a qualified ex17 ternal review entity shall be made—

18 (I) under a process that is recog19 nized or approved by the appropriate 

20 Secretary; or 

21 (II) by a qualified private stand22 ard-setting organization that is ap23 proved by the appropriate Secretary 

24 under clause (iii).
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•S 2083 IS 

1 In taking action under subclause (I), the 

2 appropriate Secretary shall give deference 

3 to entities that are under contract with the 

4 Federal Government or with an applicable 

5 State authority to perform functions of the 

6 type performed by qualified external review 

7 entities. 

8 (ii) PROCESS.—The appropriate Sec9 retary shall not recognize or approve a 

10 process under clause (i)(I) unless the proc11 ess applies standards (as promulgated in 

12 regulations) that ensure that a qualified 

13 external review entity—

14 (I) will carry out (and has car15 ried out, in the case of recertification) 

16 the responsibilities of such an entity 

17 in accordance with this section, in18 cluding meeting applicable deadlines; 

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

20 the case of recertification) appropriate 

21 indicators of fiscal integrity; 

22 (III) will maintain (and has 

23 maintained, in the case of recertifi24 cation) appropriate confidentiality 

25 with respect to individually identifi-
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•S 2083 IS 

1 able health information obtained in 

2 the course of conducting external re3 view activities; and 

4 (IV) in the case recertification, 

5 shall review the matters described in 

6 clause (iv). 

7 (iii) APPROVAL OF QUALIFIED PRI8 VATE STANDARD-SETTING ORGANIZA9 TIONS.—For purposes of clause (i)(II), the 

10 appropriate Secretary may approve a quali11 fied private standard-setting organization 

12 if such Secretary finds that the organiza13 tion only certifies (or recertifies) external 

14 review entities that meet at least the 

15 standards required for the certification (or 

16 recertification) of external review entities 

17 under clause (ii). 

18 (iv) CONSIDERATIONS IN RECERTIFI19 CATIONS.—In conducting recertifications of 

20 a qualified external review entity under 

21 this paragraph, the appropriate Secretary 

22 or organization conducting the recertifi23 cation shall review compliance of the entity 

24 with the requirements for conducting ex-
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•S 2083 IS 

1 ternal review activities under this section, 

2 including the following: 

3 (I) Provision of information 

4 under subparagraph (D). 

5 (II) Adherence to applicable 

6 deadlines (both by the entity and by 

7 independent medical reviewers it re8 fers cases to). 

9 (III) Compliance with limitations 

10 on compensation (with respect to both 

11 the entity and independent medical re12 viewers it refers cases to). 

13 (IV) Compliance with applicable 

14 independence requirements. 

15 (V) Compliance with the require16 ment of subsection (d)(1) that only 

17 medically reviewable decisions shall be 

18 the subject of independent medical re19 view and with the requirement of sub20 section (d)(3) that independent med21 ical reviewers may not require cov22 erage for specifically excluded bene23 fits. 

24 (v) PERIOD OF CERTIFICATION OR RE25 CERTIFICATION.—A certification or recer-
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•S 2083 IS 

1 tification provided under this paragraph 

2 shall extend for a period not to exceed 2 

3 years. 

4 (vi) REVOCATION.—A certification or 

5 recertification under this paragraph may 

6 be revoked by the appropriate Secretary or 

7 by the organization providing such certifi8 cation upon a showing of cause. The Sec9 retary, or organization, shall revoke a cer10 tification or deny a recertification with re11 spect to an entity if there is a showing that 

12 the entity has a pattern or practice of or13 dering coverage for benefits that are spe14 cifically excluded under the plan or cov15 erage. 

16 (vii) PETITION FOR DENIAL OR WITH17 DRAWAL.—An individual may petition the 

18 Secretary, or an organization providing the 

19 certification involves, for a denial of recer20 tification or a withdrawal of a certification 

21 with respect to an entity under this sub22 paragraph if there is a pattern or practice 

23 of such entity failing to meet a require24 ment of this section. 
65

•S 2083 IS 

1 (viii) SUFFICIENT NUMBER OF ENTI2 TIES.—The appropriate Secretary shall 

3 certify and recertify a number of external 

4 review entities which is sufficient to ensure 

5 the timely and efficient provision of review 

6 services. 

7 (D) PROVISION OF INFORMATION.—

8 (i) IN GENERAL.—A qualified external 

9 review entity shall provide to the appro10 priate Secretary, in such manner and at 

11 such times as such Secretary may require, 

12 such information (relating to the denials 

13 which have been referred to the entity for 

14 the conduct of external review under this 

15 section) as such Secretary determines ap16 propriate to assure compliance with the 

17 independence and other requirements of 

18 this section to monitor and assess the qual19 ity of its external review activities and lack 

20 of bias in making determinations. Such in21 formation shall include information de22 scribed in clause (ii) but shall not include 

23 individually identifiable medical informa24 tion.
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•S 2083 IS 

1 (ii) INFORMATION TO BE IN2 CLUDED.—The information described in 

3 this subclause with respect to an entity is 

4 as follows: 

5 (I) The number and types of de6 nials for which a request for review 

7 has been received by the entity. 

8 (II) The disposition by the entity 

9 of such denials, including the number 

10 referred to a independent medical re11 viewer and the reasons for such dis12 positions (including the application of 

13 exclusions), on a plan or issuer-spe14 cific basis and on a health care spe15 cialty-specific basis. 

16 (III) The length of time in mak17 ing determinations with respect to 

18 such denials. 

19 (IV) Updated information on the 

20 information required to be submitted 

21 as a condition of certification with re22 spect to the entity’s performance of 

23 external review activities. 

24 (iii) INFORMATION TO BE PROVIDED

25 TO CERTIFYING ORGANIZATION.—
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•S 2083 IS 

1 (I) IN GENERAL.—In the case of 

2 a qualified external review entity 

3 which is certified (or recertified) 

4 under this subsection by a qualified 

5 private standard-setting organization, 

6 at the request of the organization, the 

7 entity shall provide the organization 

8 with the information provided to the 

9 appropriate Secretary under clause 

10 (i). 

11 (II) ADDITIONAL INFORMA12 TION.—Nothing in this subparagraph 

13 shall be construed as preventing such 

14 an organization from requiring addi15 tional information as a condition of 

16 certification or recertification of an 

17 entity. 

18 (iv) USE OF INFORMATION.—Informa19 tion provided under this subparagraph may 

20 be used by the appropriate Secretary and 

21 qualified private standard-setting organiza22 tions to conduct oversight of qualified ex23 ternal review entities, including recertifi24 cation of such entities, and shall be made 
68

•S 2083 IS 

1 available to the public in an appropriate 

2 manner. 

3 (E) LIMITATION ON LIABILITY.—No quali4 fied external review entity having a contract 

5 with a plan or issuer, and no person who is em6 ployed by any such entity or who furnishes pro7 fessional services to such entity (including as an 

8 independent medical reviewer), shall be held by 

9 reason of the performance of any duty, func10 tion, or activity required or authorized pursuant 

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

12 of the United States or of any State (or polit13 ical subdivision thereof) if there was no actual 

14 malice or gross misconduct in the performance 

15 of such duty, function, or activity. 

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

17 the general effective date referred to in section 501, 

18 the General Accounting Office shall prepare and 

19 submit to the appropriate committees of Congress a 

20 report concerning—

21 (A) the information that is provided under 

22 paragraph (3)(D); 

23 (B) the number of denials that have been 

24 upheld by independent medical reviewers and 
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•S 2083 IS 

1 the number of denials that have been reversed 

2 by such reviewers; and 

3 (C) the extent to which independent med4 ical reviewers are requiring coverage for bene5 fits that are specifically excluded under the plan 

6 or coverage. 

7 SEC. 105. HEALTH CARE CONSUMER ASSISTANCE FUND. 

8 (a) GRANTS.—

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

10 Human Services (referred to in this section as the 

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

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

13 used to award grants to eligible States to carry out 

14 consumer assistance activities (including programs 

15 established by States prior to the enactment of this 

16 Act) designed to provide information, assistance, and 

17 referrals to consumers of health insurance products. 

18 (2) STATE ELIGIBILITY.—To be eligible to re19 ceive a grant under this subsection a State shall pre20 pare and submit to the Secretary an application at 

21 such time, in such manner, and containing such in22 formation as the Secretary may require, including a 

23 State plan that describes—

24 (A) the manner in which the State will en25 sure that the health care consumer assistance
70

•S 2083 IS 

1 office (established under paragraph (4)) will 

2 educate and assist health care consumers in ac3 cessing needed care; 

4 (B) the manner in which the State will co5 ordinate and distinguish the services provided 

6 by the health care consumer assistance office 

7 with the services provided by Federal, State and 

8 local health-related ombudsman, information, 

9 protection and advocacy, insurance, and fraud 

10 and abuse programs; 

11 (C) the manner in which the State will 

12 provide information, outreach, and services to 

13 underserved, minority populations with limited 

14 English proficiency and populations residing in 

15 rural areas; 

16 (D) the manner in which the State will 

17 oversee the health care consumer assistance of18 fice, its activities, product materials and evalu19 ate program effectiveness; 

20 (E) the manner in which the State will en21 sure that funds made available under this sec22 tion will be used to supplement, and not sup23 plant, any other Federal, State, or local funds 

24 expended to provide services for programs de-
71

•S 2083 IS 

1 scribed under this section and those described 

2 in subparagraphs (C) and (D); 

3 (F) the manner in which the State will en4 sure that health care consumer office personnel 

5 have the professional background and training 

6 to carry out the activities of the office; and 

7 (G) the manner in which the State will en8 sure that consumers have direct access to con9 sumer assistance personnel during regular busi10 ness hours. 

11 (3) AMOUNT OF GRANT.—

12 (A) IN GENERAL.—From amounts appro13 priated under subsection (b) for a fiscal year, 

14 the Secretary shall award a grant to a State in 

15 an amount that bears the same ratio to such 

16 amounts as the number of individuals within 

17 the State covered under a group health plan or 

18 under health insurance coverage offered by a 

19 health insurance issuer bears to the total num20 ber of individuals so covered in all States (as 

21 determined by the Secretary). Any amounts 

22 provided to a State under this subsection that 

23 are not used by the State shall be remitted to 

24 the Secretary and reallocated in accordance 

25 with this subparagraph. 
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•S 2083 IS 

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

2 the amount provided to a State under a grant 

3 under this subsection for a fiscal year be less 

4 than an amount equal to 0.5 percent of the 

5 amount appropriated for such fiscal year to 

6 carry out this section. 

7 (C) NON-FEDERAL CONTRIBUTIONS.—A 

8 State will provide for the collection of non-Fed9 eral contributions for the operation of the office 

10 in an amount that is not less than 25 percent 

11 of the amount of Federal funds provided to the 

12 State under this section. 

13 (4) PROVISION OF FUNDS FOR ESTABLISHMENT

14 OF OFFICE.—

15 (A) IN GENERAL.—From amounts pro16 vided under a grant under this subsection, a 

17 State shall, directly or through a contract with 

18 an independent, nonprofit entity with dem19 onstrated experience in serving the needs of 

20 health care consumers, provide for the estab21 lishment and operation of a State health care 

22 consumer assistance office. 

23 (B) ELIGIBILITY OF ENTITY.—To be eligi24 ble to enter into a contract under subparagraph 

25 (A), an entity shall demonstrate that it has the 
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•S 2083 IS 

1 technical, organizational, and professional ca2 pacity to deliver the services described in sub3 section (b) to all public and private health in4 surance participants, beneficiaries, enrollees, or 

5 prospective enrollees. 

6 (C) EXISTING STATE ENTITY.—Nothing in 

7 this section shall prevent the funding of an ex8 isting health care consumer assistance program 

9 that otherwise meets the requirements of this 

10 section. 

11 (b) USE OF FUNDS.—

12 (1) BY STATE.—A State shall use amounts pro13 vided under a grant awarded under this section to 

14 carry out consumer assistance activities directly or 

15 by contract with an independent, non-profit organi16 zation. An eligible entity may use some reasonable 

17 amount of such grant to ensure the adequate train18 ing of personnel carrying out such activities. To re19 ceive amounts under this subsection, an eligible enti20 ty shall provide consumer assistance services, includ21 ing—

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

23 hotline to respond to consumer requests; 

24 (B) the dissemination of appropriate edu25 cational materials on available health insurance
74

•S 2083 IS 

1 products and on how best to access health care 

2 and the rights and responsibilities of health 

3 care consumers; 

4 (C) the provision of education on effective 

5 methods to promptly and efficiently resolve 

6 questions, problems, and grievances; 

7 (D) the coordination of educational and 

8 outreach efforts with health plans, health care 

9 providers, payers, and governmental agencies; 

10 (E) referrals to appropriate private and 

11 public entities to resolve questions, problems 

12 and grievances; and 

13 (F) the provision of information and as14 sistance, including acting as an authorized rep15 resentative, regarding internal, external, or ad16 ministrative grievances or appeals procedures in 

17 nonlitigative settings to appeal the denial, ter18 mination, or reduction of health care services, 

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

20 group health plan or health insurance coverage 

21 offered by a health insurance issuer. 

22 (2) CONFIDENTIALITY AND ACCESS TO INFOR23 MATION.—

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

25 State that directly establishes a health care con-
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•S 2083 IS 

1 sumer assistance office, such office shall estab2 lish and implement procedures and protocols in 

3 accordance with applicable Federal and State 

4 laws. 

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

6 State that, through contract, establishes a 

7 health care consumer assistance office, such of8 fice shall establish and implement procedures 

9 and protocols, consistent with applicable Fed10 eral and State laws, to ensure the confiden11 tiality of all information shared by a partici12 pant, beneficiary, enrollee, or their personal 

13 representative and their health care providers, 

14 group health plans, or health insurance insurers 

15 with the office and to ensure that no such infor16 mation is used by the office, or released or dis17 closed to State agencies or outside persons or 

18 entities without the prior written authorization 

19 (in accordance with section 164.508 of title 45, 

20 Code of Federal Regulations) of the individual 

21 or personal representative. The office may, con22 sistent with applicable Federal and State con23 fidentiality laws, collect, use or disclose aggre24 gate information that is not individually identi25 fiable (as defined in section 164.501 of title 45, 
76

•S 2083 IS 

1 Code of Federal Regulations). The office shall 

2 provide a written description of the policies and 

3 procedures of the office with respect to the 

4 manner in which health information may be 

5 used or disclosed to carry out consumer assist6 ance activities. The office shall provide health 

7 care providers, group health plans, or health in8 surance issuers with a written authorization (in 

9 accordance with section 164.508 of title 45, 

10 Code of Federal Regulations) to allow the office 

11 to obtain medical information relevant to the 

12 matter before the office. 

13 (3) AVAILABILITY OF SERVICES.—The health 

14 care consumer assistance office of a State shall not 

15 discriminate in the provision of information, refer16 rals, and services regardless of the source of the in17 dividual’s health insurance coverage or prospective 

18 coverage, including individuals covered under a 

19 group health plan or health insurance coverage of20 fered by a health insurance issuer, the medicare or 

21 medicaid programs under title XVIII or XIX of the 

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

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

24 care program. 

25 (4) DESIGNATION OF RESPONSIBILITIES.—
77

•S 2083 IS 

1 (A) WITHIN EXISTING STATE ENTITY.—If 

2 the health care consumer assistance office of a 

3 State is located within an existing State regu4 latory agency or office of an elected State offi5 cial, the State shall ensure that—

6 (i) there is a separate delineation of 

7 the funding, activities, and responsibilities 

8 of the office as compared to the other 

9 funding, activities, and responsibilities of 

10 the agency; and 

11 (ii) the office establishes and imple12 ments procedures and protocols to ensure 

13 the confidentiality of all information 

14 shared by a participant, beneficiary, or en15 rollee or their personal representative and 

16 their health care providers, group health 

17 plans, or health insurance issuers with the 

18 office and to ensure that no information is 

19 disclosed to the State agency or office 

20 without the written authorization of the in21 dividual or their personal representative in 

22 accordance with paragraph (2). 

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

24 entity that enters into a contract with a State 

25 under subsection (a)(3), the entity shall provide 
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•S 2083 IS 

1 assurances that the entity has no conflict of in2 terest in carrying out the activities of the office 

3 and that the entity is independent of group 

4 health plans, health insurance issuers, pro5 viders, payers, and regulators of health care. 

6 (5) SUBCONTRACTS.—The health care con7 sumer assistance office of a State may carry out ac8 tivities and provide services through contracts en9 tered into with 1 or more nonprofit entities so long 

10 as the office can demonstrate that all of the require11 ments of this section are complied with by the office. 

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

13 subsection shall be for a term of 3 years. 

14 (c) REPORT.—Not later than 1 year after the Sec15 retary first awards grants under this section, and annually 

16 thereafter, the Secretary shall prepare and submit to the 

17 appropriate committees of Congress a report concerning 

18 the activities funded under this section and the effective19 ness of such activities in resolving health care-related 

20 problems and grievances. 

21 (d) AUTHORIZATION OF APPROPRIATIONS.—There 

22 are authorized to be appropriated such sums as may be 

23 necessary to carry out this section.
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•S 2083 IS 

1 Subtitle B—Access to Care 

2 SEC. 111. CONSUMER CHOICE OPTION. 

3 (a) IN GENERAL.—If—

4 (1) a health insurance issuer providing health 

5 insurance coverage in connection with a group health 

6 plan offers to enrollees health insurance coverage 

7 which provides for coverage of services only if such 

8 services are furnished through health care profes9 sionals and providers who are members of a network 

10 of health care professionals and providers who have 

11 entered into a contract with the issuer to provide 

12 such services, or 

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

14 beneficiaries health benefits which provide for cov15 erage of services only if such services are furnished 

16 through health care professionals and providers who 

17 are members of a network of health care profes18 sionals and providers who have entered into a con19 tract with the plan to provide such services—

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

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

22 the time of enrollment and during an annual open season 

23 as provided under subsection (c)) the option of health in24 surance coverage or health benefits which provide for cov25 erage of such services which are not furnished through 
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•S 2083 IS 

1 health care professionals and providers who are members 

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

3 beneficiaries are offered such non-network coverage 

4 through another group health plan or through another 

5 health insurance issuer in the group market. 

6 (b) ADDITIONAL COSTS.—The amount of any addi7 tional premium charged by the health insurance issuer or 

8 group health plan for the additional cost of the creation 

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

10 and the amount of any additional cost sharing imposed 

11 under such option shall be borne by the enrollee, partici12 pant, or beneficiary unless it is paid by the health plan 

13 sponsor or group health plan through agreement with the 

14 health insurance issuer. 

15 (c) OPEN SEASON.—An enrollee, participant, or ben16 eficiary, may change to the offering provided under this 

17 section only during a time period determined by the health 

18 insurance issuer or group health plan. Such time period 

19 shall occur at least annually. 

20 SEC. 112. CHOICE OF HEALTH CARE PROFESSIONAL. 

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

22 health insurance issuer that offers health insurance cov23 erage, requires or provides for designation by a partici24 pant, beneficiary, or enrollee of a participating primary 

25 care provider, then the plan or issuer shall permit each 
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•S 2083 IS 

1 participant, beneficiary, and enrollee to designate any par2 ticipating primary care provider who is available to accept 

3 such individual. 

4 (b) SPECIALISTS.—

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

6 group health plan and a health insurance issuer that 

7 offers health insurance coverage shall permit each 

8 participant, beneficiary, or enrollee to receive medi9 cally necessary and appropriate specialty care, pur10 suant to appropriate referral procedures, from any 

11 qualified participating health care professional who 

12 is available to accept such individual for such care. 

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

14 apply to specialty care if the plan or issuer clearly 

15 informs participants, beneficiaries, and enrollees of 

16 the limitations on choice of participating health care 

17 professionals with respect to such care. 

18 (3) CONSTRUCTION.—Nothing in this sub19 section shall be construed as affecting the applica20 tion of section 114 (relating to access to specialty 

21 care). 

22 SEC. 113. ACCESS TO EMERGENCY CARE. 

23 (a) COVERAGE OF EMERGENCY SERVICES.—

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

25 health insurance coverage offered by a health insur-
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•S 2083 IS 

1 ance issuer, provides or covers any benefits with re2 spect to services in an emergency department of a 

3 hospital, the plan or issuer shall cover emergency 

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

5 (A) without the need for any prior author6 ization determination; 

7 (B) whether the health care provider fur8 nishing such services is a participating provider 

9 with respect to such services; 

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

11 are provided to a participant, beneficiary, or en12 rollee—

13 (i) by a nonparticipating health care 

14 provider with or without prior authoriza15 tion, or 

16 (ii) by a participating health care pro17 vider without prior authorization—

18 the participant, beneficiary, or enrollee is not 

19 liable for amounts that exceed the amounts of 

20 liability that would be incurred if the services 

21 were provided by a participating health care 

22 provider with prior authorization; and 

23 (D) without regard to any other term or 

24 condition of such coverage (other than exclusion 

25 or coordination of benefits, or an affiliation or 
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•S 2083 IS 

1 waiting period, permitted under section 2701 of 

2 the Public Health Service Act, section 701 of 

3 the Employee Retirement Income Security Act 

4 of 1974, or section 9801 of the Internal Rev5 enue Code of 1986, and other than applicable 

6 cost-sharing). 

7 (2) DEFINITIONS.—In this section: 

8 (A) EMERGENCY MEDICAL CONDITION.—

9 The term ‘‘emergency medical condition’’ means 

10 a medical condition manifesting itself by acute 

11 symptoms of sufficient severity (including se12 vere pain) such that a prudent layperson, who 

13 possesses an average knowledge of health and 

14 medicine, could reasonably expect the absence 

15 of immediate medical attention to result in a 

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

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

18 Act. 

19 (B) EMERGENCY SERVICES.—The term 

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

21 emergency medical condition—

22 (i) a medical screening examination 

23 (as required under section 1867 of the So24 cial Security Act) that is within the capa25 bility of the emergency department of a
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•S 2083 IS 

1 hospital, including ancillary services rou2 tinely available to the emergency depart3 ment to evaluate such emergency medical 

4 condition, and 

5 (ii) within the capabilities of the staff 

6 and facilities available at the hospital, such 

7 further medical examination and treatment 

8 as are required under section 1867 of such 

9 Act to stabilize the patient. 

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

11 with respect to an emergency medical condition 

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

13 meaning give in section 1867(e)(3) of the Social 

14 Security Act (42 U.S.C. 1395dd(e)(3)). 

15 (b) REIMBURSEMENT FOR MAINTENANCE CARE AND

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

17 health insurance coverage offered by a health insurance 

18 issuer, must provide reimbursement for maintenance care 

19 and post-stabilization care in accordance with the require20 ments of section 1852(d)(2) of the Social Security Act (42 

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

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

23 (c) COVERAGE OF EMERGENCY AMBULANCE SERV24 ICES.—
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•S 2083 IS 

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

2 health insurance coverage provided by a health in3 surance issuer, provides any benefits with respect to 

4 ambulance services and emergency services, the plan 

5 or issuer shall cover emergency ambulance services 

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

7 plan or coverage under the same terms and condi8 tions under subparagraphs (A) through (D) of sub9 section (a)(1) under which coverage is provided for 

10 emergency services. 

11 (2) EMERGENCY AMBULANCE SERVICES.—For 

12 purposes of this subsection, the term ‘‘emergency 

13 ambulance services’’ means ambulance services (as 

14 defined for purposes of section 1861(s)(7) of the So15 cial Security Act) furnished to transport an indi16 vidual who has an emergency medical condition (as 

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

18 receipt of emergency services (as defined in sub19 section (a)(2)(B)) in a case in which the emergency 

20 services are covered under the plan or coverage pur21 suant to subsection (a)(1) and a prudent layperson, 

22 with an average knowledge of health and medicine, 

23 could reasonably expect that the absence of such 

24 transport would result in placing the health of the 

25 individual in serious jeopardy, serious impairment of 
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•S 2083 IS 

1 bodily function, or serious dysfunction of any bodily 

2 organ or part. 

3 SEC. 114. TIMELY ACCESS TO SPECIALISTS. 

4 (a) TIMELY ACCESS.—

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

6 health insurance issuer offering health insurance 

7 coverage shall ensure that participants, beneficiaries, 

8 and enrollees receive timely access to specialists who 

9 are appropriate to the condition of, and accessible 

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

11 such specialty care is a covered benefit under the 

12 plan or coverage. 

13 (2) RULE OF CONSTRUCTION.—Nothing in 

14 paragraph (1) shall be construed—

15 (A) to require the coverage under a group 

16 health plan or health insurance coverage of ben17 efits or services; 

18 (B) to prohibit a plan or issuer from in19 cluding providers in the network only to the ex20 tent necessary to meet the needs of the plan’s 

21 or issuer’s participants, beneficiaries, or enroll22 ees; or 

23 (C) to override any State licensure or 

24 scope-of-practice law. 

25 (3) ACCESS TO CERTAIN PROVIDERS.—
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•S 2083 IS 

1 (A) IN GENERAL.—With respect to spe2 cialty care under this section, if a participating 

3 specialist is not available and qualified to pro4 vide such care to the participant, beneficiary, or 

5 enrollee, the plan or issuer shall provide for cov6 erage of such care by a nonparticipating spe7 cialist. 

8 (B) TREATMENT OF NONPARTICIPATING

9 PROVIDERS.—If a participant, beneficiary, or 

10 enrollee receives care from a nonparticipating 

11 specialist pursuant to subparagraph (A), such 

12 specialty care shall be provided at no additional 

13 cost to the participant, beneficiary, or enrollee 

14 beyond what the participant, beneficiary, or en15 rollee would otherwise pay for such specialty 

16 care if provided by a participating specialist. 

17 (b) REFERRALS.—

18 (1) AUTHORIZATION.—Subject to subsection 

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

20 issuer may require an authorization in order to ob21 tain coverage for specialty services under this sec22 tion. Any such authorization—

23 (A) shall be for an appropriate duration of 

24 time or number of referrals, including an au-
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•S 2083 IS 

1 thorization for a standing referral where appro2 priate; and 

3 (B) may not be refused solely because the 

4 authorization involves services of a nonpartici5 pating specialist (described in subsection 

6 (a)(3)). 

7 (2) REFERRALS FOR ONGOING SPECIAL CONDI8 TIONS.—

9 (A) IN GENERAL.—Subject to subsection 

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

11 issuer shall permit a participant, beneficiary, or 

12 enrollee who has an ongoing special condition 

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

14 referral to a specialist for the treatment of such 

15 condition and such specialist may authorize 

16 such referrals, procedures, tests, and other 

17 medical services with respect to such condition, 

18 or coordinate the care for such condition, sub19 ject to the terms of a treatment plan (if any) 

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

21 condition. 

22 (B) ONGOING SPECIAL CONDITION DE23 FINED.—In this subsection, the term ‘‘ongoing 

24 special condition’’ means a condition or disease 

25 that—
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•S 2083 IS 

1 (i) is life-threatening, degenerative, 

2 potentially disabling, or congenital; and 

3 (ii) requires specialized medical care 

4 over a prolonged period of time. 

5 (c) TREATMENT PLANS.—

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

7 health insurance issuer may require that the spe8 cialty care be provided—

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

10 if the treatment plan—

11 (i) is developed by the specialist, in 

12 consultation with the case manager or pri13 mary care provider, and the participant, 

14 beneficiary, or enrollee, and 

15 (ii) is approved by the plan or issuer 

16 in a timely manner, if the plan or issuer 

17 requires such approval; and 

18 (B) in accordance with applicable quality 

19 assurance and utilization review standards of 

20 the plan or issuer. 

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

22 shall be construed as prohibiting a plan or issuer 

23 from requiring the specialist to provide the plan or 

24 issuer with regular updates on the specialty care 
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•S 2083 IS 

1 provided, as well as all other reasonably necessary 

2 medical information. 

3 (d) SPECIALIST DEFINED.—For purposes of this sec4 tion, the term ‘‘specialist’’ means, with respect to the con5 dition of the participant, beneficiary, or enrollee, a health 

6 care professional, facility, or center that has adequate ex7 pertise through appropriate training and experience (in8 cluding, in the case of a child, appropriate pediatric exper9 tise) to provide high quality care in treating the condition. 

10 SEC. 115. PATIENT ACCESS TO OBSTETRICAL AND GYNECO11 LOGICAL CARE. 

12 (a) GENERAL RIGHTS.—

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

14 health insurance issuer offering health insurance 

15 coverage, described in subsection (b) may not re16 quire authorization or referral by the plan, issuer, or 

17 any person (including a primary care provider de18 scribed in subsection (b)(2)) in the case of a female 

19 participant, beneficiary, or enrollee who seeks cov20 erage for obstetrical or gynecological care provided 

21 by a participating health care professional who spe22 cializes in obstetrics or gynecology. 

23 (2) OBSTETRICAL AND GYNECOLOGICAL

24 CARE.—A group health plan or health insurance 

25 issuer described in subsection (b) shall treat the pro-
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•S 2083 IS 

1 vision of obstetrical and gynecological care, and the 

2 ordering of related obstetrical and gynecological 

3 items and services, pursuant to the direct access de4 scribed under paragraph (1), by a participating 

5 health care professional who specializes in obstetrics 

6 or gynecology as the authorization of the primary 

7 care provider. 

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

9 or health insurance issuer offering health insurance cov10 erage, described in this subsection is a group health plan 

11 or coverage that—

12 (1) provides coverage for obstetric or 

13 gynecologic care; and 

14 (2) requires the designation by a participant, 

15 beneficiary, or enrollee of a participating primary 

16 care provider. 

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

18 be construed to—

19 (1) waive any exclusions of coverage under the 

20 terms and conditions of the plan or health insurance 

21 coverage with respect to coverage of obstetrical or 

22 gynecological care; or 

23 (2) preclude the group health plan or health in24 surance issuer involved from requiring that the ob25 stetrical or gynecological provider notify the primary 
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•S 2083 IS 

1 care health care professional or the plan or issuer of 

2 treatment decisions. 

3 SEC. 116. ACCESS TO PEDIATRIC CARE. 

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

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

6 under a group health plan, or health insurance coverage 

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

8 requires or provides for the designation of a participating 

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

10 permit such person to designate a physician (allopathic or 

11 osteopathic) who specializes in pediatrics as the child’s pri12 mary care provider if such provider participates in the net13 work of the plan or issuer. 

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

15 be construed to waive any exclusions of coverage under 

16 the terms and conditions of the plan or health insurance 

17 coverage with respect to coverage of pediatric care. 

18 SEC. 117. CONTINUITY OF CARE. 

19 (a) TERMINATION OF PROVIDER.—

20 (1) IN GENERAL.—If—

21 (A) a contract between a group health 

22 plan, or a health insurance issuer offering 

23 health insurance coverage, and a treating health 

24 care provider is terminated (as defined in para25 graph (e)(4)), or 
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•S 2083 IS 

1 (B) benefits or coverage provided by a 

2 health care provider are terminated because of 

3 a change in the terms of provider participation 

4 in such plan or coverage—

5 the plan or issuer shall meet the requirements of 

6 paragraph (3) with respect to each continuing care 

7 patient. 

8 (2) TREATMENT OF TERMINATION OF CON9 TRACT WITH HEALTH INSURANCE ISSUER.—If a 

10 contract for the provision of health insurance cov11 erage between a group health plan and a health in12 surance issuer is terminated and, as a result of such 

13 termination, coverage of services of a health care 

14 provider is terminated with respect to an individual, 

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

16 provisions of this section) shall apply under the plan 

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

18 between the plan and the provider that had been ter19 minated, but only with respect to benefits that are 

20 covered under the plan after the contract termi21 nation. 

22 (3) REQUIREMENTS.—The requirements of this 

23 paragraph are that the plan or issuer—

24 (A) notify the continuing care patient in25 volved, or arrange to have the patient notified
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•S 2083 IS 

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

2 of the termination described in paragraph (1) 

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

4 to elect continued transitional care from the 

5 provider under this section; 

6 (B) provide the patient with an oppor7 tunity to notify the plan or issuer of the pa8 tient’s need for transitional care; and 

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

10 patient to elect to continue to be covered with 

11 respect to the course of treatment by such pro12 vider with the provider’s consent during a tran13 sitional period (as provided for under subsection 

14 (b)). 

15 (4) CONTINUING CARE PATIENT.—For purposes 

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

17 means a participant, beneficiary, or enrollee who—

18 (A) is undergoing a course of treatment 

19 for a serious and complex condition from the 

20 provider at the time the plan or issuer receives 

21 or provides notice of provider, benefit, or cov22 erage termination described in paragraph (1) 

23 (or paragraph (2), if applicable); 
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•S 2083 IS 

1 (B) is undergoing a course of institutional 

2 or inpatient care from the provider at the time 

3 of such notice; 

4 (C) is scheduled to undergo non-elective 

5 surgery from the provider at the time of such 

6 notice; 

7 (D) is pregnant and undergoing a course 

8 of treatment for the pregnancy from the pro9 vider at the time of such notice; or 

10 (E) is or was determined to be terminally 

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

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

13 notice, but only with respect to a provider that 

14 was treating the terminal illness before the date 

15 of such notice. 

16 (b) TRANSITIONAL PERIODS.—

17 (1) SERIOUS AND COMPLEX CONDITIONS.—The 

18 transitional period under this subsection with re19 spect to a continuing care patient described in sub20 section (a)(4)(A) shall extend for up to 90 days (as 

21 determined by the treating health care professional) 

22 from the date of the notice described in subsection 

23 (a)(3)(A). 

24 (2) INSTITUTIONAL OR INPATIENT CARE.—The 

25 transitional period under this subsection for a con-
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•S 2083 IS 

1 tinuing care patient described in subsection 

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

3 (A) the expiration of the 90-day period be4 ginning on the date on which the notice under 

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

6 (B) the date of discharge of the patient 

7 from such care or the termination of the period 

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

9 completion of reasonable follow-up care. 

10 (3) SCHEDULED NON-ELECTIVE SURGERY.—

11 The transitional period under this subsection for a 

12 continuing care patient described in subsection 

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

14 surgery involved and post-surgical follow-up care re15 lating to the surgery and occurring within 90 days 

16 after the date of the surgery. 

17 (4) PREGNANCY.—The transitional period 

18 under this subsection for a continuing care patient 

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

20 through the provision of post-partum care directly 

21 related to the delivery. 

22 (5) TERMINAL ILLNESS.—The transitional pe23 riod under this subsection for a continuing care pa24 tient described in subsection (a)(4)(E) shall extend 

25 for the remainder of the patient’s life for care that 
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•S 2083 IS 

1 is directly related to the treatment of the terminal 

2 illness or its medical manifestations. 

3 (c) PERMISSIBLE TERMS AND CONDITIONS.—A 

4 group health plan or health insurance issuer may condi5 tion coverage of continued treatment by a provider under 

6 this section upon the provider agreeing to the following 

7 terms and conditions: 

8 (1) The treating health care provider agrees to 

9 accept reimbursement from the plan or issuer and 

10 continuing care patient involved (with respect to 

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

12 start of the transitional period as payment in full 

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

14 rates applicable under the replacement plan or cov15 erage after the date of the termination of the con16 tract with the group health plan or health insurance 

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

18 to the patient in an amount that would exceed the 

19 cost-sharing that could have been imposed if the 

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

21 been terminated. 

22 (2) The treating health care provider agrees to 

23 adhere to the quality assurance standards of the 

24 plan or issuer responsible for payment under para25 graph (1) and to provide to such plan or issuer nec-
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•S 2083 IS 

1 essary medical information related to the care pro2 vided. 

3 (3) The treating health care provider agrees 

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

5 and procedures, including procedures regarding re6 ferrals and obtaining prior authorization and pro7 viding services pursuant to a treatment plan (if any) 

8 approved by the plan or issuer. 

9 (d) RULES OF CONSTRUCTION.—Nothing in this sec10 tion shall be construed—

11 (1) to require the coverage of benefits which 

12 would not have been covered if the provider involved 

13 remained a participating provider; or 

14 (2) with respect to the termination of a con15 tract under subsection (a) to prevent a group health 

16 plan or health insurance issuer from requiring that 

17 the health care provider—

18 (A) notify participants, beneficiaries, or en19 rollees of their rights under this section; or 

20 (B) provide the plan or issuer with the 

21 name of each participant, beneficiary, or en22 rollee who the provider believes is a continuing 

23 care patient. 

24 (e) DEFINITIONS.—In this section:
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•S 2083 IS 

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

2 with respect to a plan or issuer and a treating 

3 health care provider, a contract between such plan 

4 or issuer and an organized network of providers that 

5 includes the treating health care provider, and (in 

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

7 treating health care provider and the organized net8 work. 

9 (2) HEALTH CARE PROVIDER.—The term 

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

11 (A) any individual who is engaged in the 

12 delivery of health care services in a State and 

13 who is required by State law or regulation to be 

14 licensed or certified by the State to engage in 

15 the delivery of such services in the State; and 

16 (B) any entity that is engaged in the deliv17 ery of health care services in a State and that, 

18 if it 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, is so 

21 licensed. 

22 (3) SERIOUS AND COMPLEX CONDITION.—The 

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

24 respect to a participant, beneficiary, or enrollee 

25 under the plan or coverage—
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•S 2083 IS 

1 (A) in the case of an acute illness, a condi2 tion that is serious enough to require special3 ized medical treatment to avoid the reasonable 

4 possibility of death or permanent harm; or 

5 (B) in the case of a chronic illness or con6 dition, is an ongoing special condition (as de7 fined in section 114(b)(2)(B)). 

8 (4) TERMINATED.—The term ‘‘terminated’’ in9 cludes, with respect to a contract, the expiration or 

10 nonrenewal of the contract, but does not include a 

11 termination of the contract for failure to meet appli12 cable quality standards or for fraud. 

13 SEC. 118. ACCESS TO NEEDED PRESCRIPTION DRUGS. 

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

15 plan, or health insurance coverage offered by a health in16 surance issuer, provides coverage for benefits with respect 

17 to prescription drugs, and limits such coverage to drugs 

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

19 (1) ensure the participation of physicians and 

20 pharmacists in developing and reviewing such for21 mulary; 

22 (2) provide for disclosure of the formulary to 

23 providers; and 

24 (3) in accordance with the applicable quality as25 surance and utilization review standards of the plan 
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•S 2083 IS 

1 or issuer, provide for exceptions from the formulary 

2 limitation when a non-formulary alternative is medi3 cally necessary and appropriate and, in the case of 

4 such an exception, apply the same cost-sharing re5 quirements that would have applied in the case of a 

6 drug covered under the formulary. 

7 (b) COVERAGE OF APPROVED DRUGS AND MEDICAL

8 DEVICES.—

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

10 health insurance coverage offered in connection with 

11 such a plan) that provides any coverage of prescrip12 tion drugs or medical devices shall not deny coverage 

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

14 is investigational, if the use—

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

16 (i) is included in the labeling author17 ized by the application in effect for the 

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

19 section 505 of the Federal Food, Drug, 

20 and Cosmetic Act, without regard to any 

21 postmarketing requirements that may 

22 apply under such Act; or 

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

25 drug under section 351 of the Public 
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•S 2083 IS 

1 Health Service Act, without regard to any 

2 postmarketing requirements that may 

3 apply pursuant to such section; or 

4 (B) in the case of a medical device, is in5 cluded in the labeling authorized by a regula6 tion under subsection (d) or (3) of section 513 

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

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

9 an application approved under section 515 of 

10 such Act, without regard to any postmarketing 

11 requirements that may apply under such Act. 

12 (2) CONSTRUCTION.—Nothing in this sub13 section shall be construed as requiring a group 

14 health plan (or health insurance coverage offered in 

15 connection with such a plan) to provide any coverage 

16 of prescription drugs or medical devices. 

17 SEC. 119. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 

18 APPROVED CLINICAL TRIALS. 

19 (a) COVERAGE.—

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

21 health insurance issuer that is providing health in22 surance coverage, provides coverage to a qualified in23 dividual (as defined in subsection (b)), the plan or 

24 issuer—
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1 (A) may not deny the individual participa2 tion in the clinical trial referred to in subsection 

3 (b)(2); 

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

5 (or limit or impose additional conditions on) the 

6 coverage of routine patient costs for items and 

7 services furnished in connection with participa8 tion in the trial; and 

9 (C) may not discriminate against the indi10 vidual on the basis of the enrollee’s participa11 tion in such trial. 

12 (2) EXCLUSION OF CERTAIN COSTS.—For pur13 poses of paragraph (1)(B), routine patient costs do 

14 not include the cost of the tests or measurements 

15 conducted primarily for the purpose of the clinical 

16 trial involved. 

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

18 or more participating providers is participating in a 

19 clinical trial, nothing in paragraph (1) shall be con20 strued as preventing a plan or issuer from requiring 

21 that a qualified individual participate in the trial 

22 through such a participating provider if the provider 

23 will accept the individual as a participant in the 

24 trial.
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•S 2083 IS 

1 (b) QUALIFIED INDIVIDUAL DEFINED.—For pur2 poses of subsection (a), the term ‘‘qualified individual’’ 

3 means an individual who is a participant or beneficiary 

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

5 insurance coverage, and who meets the following condi6 tions: 

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

8 serious illness for which no standard treatment is ef9 fective. 

10 (B) The individual is eligible to participate in 

11 an approved clinical trial according to the trial pro12 tocol with respect to treatment of such illness. 

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

14 offers meaningful potential for significant clinical 

15 benefit for the individual. 

16 (2) Either—

17 (A) the referring physician is a partici18 pating health care professional and has con19 cluded that the individual’s participation in 

20 such trial would be appropriate based upon the 

21 individual meeting the conditions described in 

22 paragraph (1); or 

23 (B) the participant, beneficiary, or enrollee 

24 provides medical and scientific information es25 tablishing that the individual’s participation in 
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•S 2083 IS 

1 such trial would be appropriate based upon the 

2 individual meeting the conditions described in 

3 paragraph (1). 

4 (c) PAYMENT.—

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

6 health plan or health insurance issuer shall provide 

7 for payment for routine patient costs described in 

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

9 of items and services that are reasonably expected 

10 (as determined by the appropriate Secretary) to be 

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

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

13 items and services provided by—

14 (A) a participating provider, the payment 

15 rate shall be at the agreed upon rate; or 

16 (B) a nonparticipating provider, the pay17 ment rate shall be at the rate the plan or issuer 

18 would normally pay for comparable services 

19 under subparagraph (A). 

20 (d) APPROVED CLINICAL TRIAL DEFINED.—

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

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

23 study or clinical investigation—
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•S 2083 IS 

1 (A) approved and funded (which may in2 clude funding through in-kind contributions) by 

3 one or more of the following: 

4 (i) the National Institutes of Health; 

5 (ii) a cooperative group or center of 

6 the National Institutes of Health, such as 

7 a qualified nongovernmental research enti8 ty to which the National Cancer Institute 

9 has awarded a center support grant; 

10 (iii) either of the following if the con11 ditions described in paragraph (2) are 

12 met—

13 (I) the Department of Veterans 

14 Affairs; 

15 (II) the Department of Defense; 

16 or 

17 (B) approved by the Food and Drug Ad18 ministration. 

19 (2) CONDITIONS FOR DEPARTMENTS.—The 

20 conditions described in this paragraph, for a study 

21 or investigation conducted by a Department, are 

22 that the study or investigation has been reviewed 

23 and approved through a system of peer review that 

24 the appropriate Secretary determines—
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•S 2083 IS 

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

2 review of studies and investigations used by the 

3 National Institutes of Health; and 

4 (B) assures unbiased review of the highest 

5 ethical standards by qualified individuals who 

6 have no interest in the outcome of the review. 

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

8 construed to limit a plan’s or issuer’s coverage with re9 spect to clinical trials. 

10 SEC. 120. REQUIRED COVERAGE FOR MINIMUM HOSPITAL 

11 STAY FOR MASTECTOMIES AND LYMPH NODE 

12 DISSECTIONS FOR THE TREATMENT OF 

13 BREAST CANCER AND COVERAGE FOR SEC14 ONDARY CONSULTATIONS. 

15 (a) INPATIENT CARE.—

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

17 health insurance issuer providing health insurance 

18 coverage, that provides medical and surgical benefits 

19 shall ensure that inpatient coverage with respect to 

20 the treatment of breast cancer is provided for a pe21 riod of time as is determined by the attending physi22 cian, in consultation with the patient, to be medi23 cally necessary and appropriate following—

24 (A) a mastectomy; 

25 (B) a lumpectomy; or 
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•S 2083 IS 

1 (C) a lymph node dissection for the treat2 ment of breast cancer. 

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

4 be construed as requiring the provision of inpatient 

5 coverage if the attending physician and patient de6 termine that a shorter period of hospital stay is 

7 medically appropriate. 

8 (b) PROHIBITION ON CERTAIN MODIFICATIONS.—In 

9 implementing the requirements of this section, a group 

10 health plan, and a health insurance issuer providing health 

11 insurance coverage, may not modify the terms and condi12 tions of coverage based on the determination by a partici13 pant, beneficiary, or enrollee to request less than the min14 imum coverage required under subsection (a). 

15 (c) SECONDARY CONSULTATIONS.—

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

17 health insurance issuer providing health insurance 

18 coverage, that provides coverage with respect to 

19 medical and surgical services provided in relation to 

20 the diagnosis and treatment of cancer shall ensure 

21 that full coverage is provided for secondary consulta22 tions by specialists in the appropriate medical fields 

23 (including pathology, radiology, and oncology) to 

24 confirm or refute such diagnosis. Such plan or issuer 

25 shall ensure that full coverage is provided for such
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•S 2083 IS 

1 secondary consultation whether such consultation is 

2 based on a positive or negative initial diagnosis. In 

3 any case in which the attending physician certifies 

4 in writing that services necessary for such a sec5 ondary consultation are not sufficiently available 

6 from specialists operating under the plan or cov7 erage with respect to whose services coverage is oth8 erwise provided under such plan or by such issuer, 

9 such plan or issuer shall ensure that coverage is pro10 vided with respect to the services necessary for the 

11 secondary consultation with any other specialist se12 lected by the attending physician for such purpose 

13 at no additional cost to the individual beyond that 

14 which the individual would have paid if the specialist 

15 was participating in the network of the plan or 

16 issuer. 

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

18 shall be construed as requiring the provision of sec19 ondary consultations where the patient determines 

20 not to seek such a consultation. 

21 (d) PROHIBITION ON PENALTIES OR INCENTIVES.—

22 A group health plan, and a health insurance issuer pro23 viding health insurance coverage, may not—

24 (1) penalize or otherwise reduce or limit the re25 imbursement of a provider or specialist because the 
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1 provider or specialist provided care to a participant, 

2 beneficiary, or enrollee in accordance with this sec3 tion; 

4 (2) provide financial or other incentives to a 

5 physician or specialist to induce the physician or 

6 specialist to keep the length of inpatient stays of pa7 tients following a mastectomy, lumpectomy, or a 

8 lymph node dissection for the treatment of breast 

9 cancer below certain limits or to limit referrals for 

10 secondary consultations; or 

11 (3) provide financial or other incentives to a 

12 physician or specialist to induce the physician or 

13 specialist to refrain from referring a participant, 

14 beneficiary, or enrollee for a secondary consultation 

15 that would otherwise be covered by the plan or cov16 erage involved under subsection (c). 

17 Subtitle C—Access to Information 

18 SEC. 121. PATIENT ACCESS TO INFORMATION. 

19 (a) REQUIREMENT.—

20 (1) DISCLOSURE.—

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

22 and a health insurance issuer that provides cov23 erage in connection with health insurance cov24 erage, shall provide for the disclosure to partici25 pants, beneficiaries, and enrollees—
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1 (i) of the information described in 

2 subsection (b) at the time of the initial en3 rollment of the participant, beneficiary, or 

4 enrollee under the plan or coverage; 

5 (ii) of such information on an annual 

6 basis—

7 (I) in conjunction with the elec8 tion period of the plan or coverage if 

9 the plan or coverage has such an elec10 tion period; or 

11 (II) in the case of a plan or cov12 erage that does not have an election 

13 period, in conjunction with the begin14 ning of the plan or coverage year; and 

15 (iii) of information relating to any 

16 material reduction to the benefits or infor17 mation described in such subsection or 

18 subsection (c), in the form of a notice pro19 vided not later than 30 days before the 

20 date on which the reduction takes effect. 

21 (B) PARTICIPANTS, BENEFICIARIES, AND

22 ENROLLEES.—The disclosure required under 

23 subparagraph (A) shall be provided—
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1 (i) jointly to each participant, bene2 ficiary, and enrollee who reside at the same 

3 address; or 

4 (ii) in the case of a beneficiary or en5 rollee who does not reside at the same ad6 dress as the participant or another en7 rollee, separately to the participant or 

8 other enrollees and such beneficiary or en9 rollee. 

10 (2) PROVISION OF INFORMATION.—Information 

11 shall be provided to participants, beneficiaries, and 

12 enrollees under this section at the last known ad13 dress maintained by the plan or issuer with respect 

14 to such participants, beneficiaries, or enrollees, to 

15 the extent that such information is provided to par16 ticipants, beneficiaries, or enrollees via the United 

17 States Postal Service or other private delivery serv18 ice. 

19 (b) REQUIRED INFORMATION.—The informational 

20 materials to be distributed under this section shall include 

21 for each option available under the group health plan or 

22 health insurance coverage the following: 

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

24 benefits, including—

25 (A) any in- and out-of-network benefits; 
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1 (B) specific preventive services covered 

2 under the plan or coverage if such services are 

3 covered; 

4 (C) any specific exclusions or express limi5 tations of benefits described in section 

6 104(d)(3)(C); 

7 (D) any other benefit limitations, including 

8 any annual or lifetime benefit limits and any 

9 monetary limits or limits on the number of vis10 its, days, or services, and any specific coverage 

11 exclusions; and 

12 (E) any definition of medical necessity 

13 used in making coverage determinations by the 

14 plan, issuer, or claims administrator. 

15 (2) COST SHARING.—A description of any cost16 sharing requirements, including—

17 (A) any premiums, deductibles, coinsur18 ance, copayment amounts, and liability for bal19 ance billing, for which the participant, bene20 ficiary, or enrollee will be responsible under 

21 each option available under the plan; 

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

23 for which the participant, beneficiary, or en24 rollee may be liable;
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1 (C) any cost-sharing requirements for out2 of-network benefits or services received from 

3 nonparticipating providers; and 

4 (D) any additional cost-sharing or charges 

5 for benefits and services that are furnished 

6 without meeting applicable plan or coverage re7 quirements, such as prior authorization or 

8 precertification. 

9 (3) DISENROLLMENT.—Information relating to 

10 the disenrollment of a participant, beneficiary, or en11 rollee. 

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

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

14 any out-of-area coverage. 

15 (5) PARTICIPATING PROVIDERS.—A directory of 

16 participating providers (to the extent a plan or 

17 issuer provides coverage through a network of pro18 viders) that includes, at a minimum, the name, ad19 dress, and telephone number of each participating 

20 provider, and information about how to inquire 

21 whether a participating provider is currently accept22 ing new patients. 

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

24 description of any requirements and procedures to 

25 be used by participants, beneficiaries, and enrollees 
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1 in selecting, accessing, or changing their primary 

2 care provider, including providers both within and 

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

4 out-of-network services), and the right to select a pe5 diatrician as a primary care provider under section 

6 116 for a participant, beneficiary, or enrollee who is 

7 a child if such section applies. 

8 (7) PREAUTHORIZATION REQUIREMENTS.—A 

9 description of the requirements and procedures to be 

10 used to obtain preauthorization for health services, 

11 if such preauthorization is required. 

12 (8) EXPERIMENTAL AND INVESTIGATIONAL

13 TREATMENTS.—A description of the process for de14 termining whether a particular item, service, or 

15 treatment is considered experimental or investiga16 tional, and the circumstances under which such 

17 treatments are covered by the plan or issuer. 

18 (9) SPECIALTY CARE.—A description of the re19 quirements and procedures to be used by partici20 pants, beneficiaries, and enrollees in accessing spe21 cialty care and obtaining referrals to participating 

22 and nonparticipating specialists, including any limi23 tations on choice of health care professionals re24 ferred to in section 112(b)(2) and the right to timely 
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1 access to specialists care under section 114 if such 

2 section applies. 

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

4 circumstances and conditions under which participa5 tion in clinical trials is covered under the terms and 

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

7 obtain coverage for approved clinical trials under 

8 section 119 if such section applies. 

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

10 plan or issuer provides coverage for prescription 

11 drugs, a statement of whether such coverage is lim12 ited to drugs included in a formulary, a description 

13 of any provisions and cost-sharing required for ob14 taining on- and off-formulary medications, and a de15 scription of the rights of participants, beneficiaries, 

16 and enrollees in obtaining access to access to pre17 scription drugs under section 118 if such section ap18 plies. 

19 (12) EMERGENCY SERVICES.—A summary of 

20 the rules and procedures for accessing emergency 

21 services, including the right of a participant, bene22 ficiary, or enrollee to obtain emergency services 

23 under the prudent layperson standard under section 

24 113, 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 Bipartisan Pa24 tient Protection Act (excluding those described in 

25 paragraphs (1) through (17)) if such sections apply.
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1 The description required under this paragraph may 

2 be combined with the notices of the type described 

3 in sections 711(d), 713(b), or 606(a)(1) of the Em4 ployee Retirement Income Security Act of 1974 and 

5 with any other notice provision that the appropriate 

6 Secretary determines may be combined, so long as 

7 such combination does not result in any reduction 

8 in the information that would otherwise be provided 

9 to the 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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•S 2083 IS 

1 and provides the information in printed 

2 form if the information is not received. 

3 SEC. 122. GENETIC INFORMATION. 

4 (a) DEFINITIONS.—In this section: 

5 (1) FAMILY MEMBER.—The term ‘‘family mem6 ber’’ means with respect to an individual—

7 (A) the spouse of the individual; 

8 (B) a dependent child of the individual, in9 cluding a child who is born to or placed for 

10 adoption with the individual; and 

11 (C) all other individuals related by blood to 

12 the individual or the spouse or child described 

13 in subparagraph (A) or (B). 

14 (2) GENETIC INFORMATION.—The term ‘‘ge15 netic information’’ means information about genes, 

16 gene products, or inherited characteristics that may 

17 derive from an individual or a family member of 

18 such individual (including information about a re19 quest for or the receipt of genetic services by such 

20 individual or a family member of such individual). 

21 (3) GENETIC SERVICES.—The term ‘‘genetic 

22 services’’ means health services, including genetic 

23 tests, provided to obtain, assess, or interpret genetic 

24 information for diagnostic and therapeutic purposes, 

25 and for genetic education and counseling.
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1 (4) GENETIC TEST.—The term ‘‘genetic test’’ 

2 means the analysis of human DNA, RNA, chro3 mosomes, proteins, and certain metabolites, includ4 ing analysis of genotypes, mutations, phenotypes, or 

5 karyotypes, for the purpose of predicting risk of dis6 ease in asymptomatic or undiagnosed individuals. 

7 Such term does not include a physical test, such as 

8 a chemical, blood, or urine analysis of an individual, 

9 including a cholesterol test, or a physical exam of 

10 the individual, in order to detect symptoms, clinical 

11 signs, or a diagnosis of disease. 

12 (5) GROUP HEALTH PLAN, HEALTH INSURANCE

13 ISSUER.—The terms ‘‘group health plan’’ and 

14 ‘‘health insurance issuer’’ include a third party ad15 ministrator or other person acting for or on behalf 

16 of such plan or issuer. 

17 (6) PREDICTIVE GENETIC INFORMATION.—

18 (A) IN GENERAL.—The term ‘‘predictive 

19 genetic information’’ means—

20 (i) information about an individual’s 

21 genetic tests; 

22 (ii) information about genetic tests of 

23 family members of the individual; or 

24 (iii) information about the occurrence 

25 of a disease or disorder in family members. 
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1 (B) LIMITATIONS.—The term ‘‘predictive 

2 genetic information’’ shall not include—

3 (i) information about the sex or age of 

4 the individual; 

5 (ii) information about chemical, blood, 

6 or urine analyses of the individual, includ7 ing cholesterol tests, unless these analyses 

8 are genetic tests, as defined in paragraph 

9 (4); or 

10 (iii) information about physical exams 

11 of the individual, and other information 

12 relevant to determining the current health 

13 status of the individual. 

14 (b) NONDISCRIMINATION.—

15 (1) NO ENROLLMENT RESTRICTION FOR GE16 NETIC SERVICES.—A group health plan, and a 

17 health insurance issuer offering health insurance 

18 coverage, shall not establish rules for eligibility (in19 cluding continued eligibility) of any individual to en20 roll under the terms of the plan or coverage based 

21 on genetic information (or information about a re22 quest for or the receipt of genetic services by such 

23 individual or a family member of such individual) in 

24 relation to the individual or a dependent of the indi25 vidual. 
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•S 2083 IS 

1 (2) NO DISCRIMINATION IN RATE BASED ON

2 PREDICTIVE GENETIC INFORMATION.—A group 

3 health plan, and a health insurance issuer offering 

4 health insurance coverage, shall not deny eligibility 

5 or adjust premium or contribution rates on the basis 

6 of predictive genetic information concerning an indi7 vidual (or information about a request for or the re8 ceipt of genetic services by such individual or a fam9 ily member of such individual). 

10 (c) COLLECTION OF PREDICTIVE GENETIC INFORMA11 TION.—

12 (1) LIMITATION ON REQUESTING OR REQUIRING

13 PREDICTIVE GENETIC INFORMATION.—Except as 

14 provided in paragraph (2), a group health plan, or 

15 a health insurance issuer offering health insurance 

16 coverage, shall not request or require predictive ge17 netic information concerning an individual or a fam18 ily member of the individual (including information 

19 about a request for or the receipt of genetic services 

20 by such individual or a family member of such indi21 vidual). 

22 (2) INFORMATION NEEDED FOR DIAGNOSIS, 

23 TREATMENT, OR PAYMENT.—

24 (A) IN GENERAL.—Notwithstanding para25 graph (1), a group health plan, or a health in-
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•S 2083 IS 

1 surance issuer offering health insurance cov2 erage, that provides health care items and serv3 ices to an individual or dependent may request 

4 (but may not require) that such individual or 

5 dependent disclose, or authorize the collection 

6 or disclosure of, predictive genetic information 

7 for purposes of diagnosis, treatment, or pay8 ment relating to the provision of health care 

9 items and services to such individual or depend10 ent. 

11 (B) NOTICE OF CONFIDENTIALITY PRAC12 TICES AND DESCRIPTION OF SAFEGUARDS.—As 

13 a part of a request under subparagraph (A), 

14 the group health plan, or a health insurance 

15 issuer offering health insurance coverage, shall 

16 provide to the individual or dependent a de17 scription of the procedures in place to safe18 guard the confidentiality, as described in sub19 section (d), of such predictive genetic informa20 tion. 

21 (d) CONFIDENTIALITY WITH RESPECT TO PRE22 DICTIVE GENETIC INFORMATION.—

23 (1) NOTICE OF CONFIDENTIALITY PRAC24 TICES.—A group health plan, or a health insurance 

25 issuer offering health insurance coverage, shall post 
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•S 2083 IS 

1 or provide, in writing and in a clear and conspicuous 

2 manner, notice of the plan or issuer’s confidentiality 

3 practices, that shall include—

4 (A) a description of an individual’s rights 

5 with respect to predictive genetic information; 

6 (B) the procedures established by the plan 

7 or issuer for the exercise of the individual’s 

8 rights; and 

9 (C) a description of the right to obtain a 

10 copy of the notice of the confidentiality prac11 tices required under this subsection. 

12 (2) ESTABLISHMENT OF SAFEGUARDS.—A 

13 group health plan, or a health insurance issuer offer14 ing health insurance coverage, shall establish and 

15 maintain appropriate administrative, technical, and 

16 physical safeguards to protect the confidentiality, se17 curity, accuracy, and integrity of predictive genetic 

18 information created, received, obtained, maintained, 

19 used, transmitted, or disposed of by such plan or 

20 issuer. 

21 (3) COMPLIANCE WITH CERTAIN STANDARDS.—

22 With respect to the establishment and maintenance 

23 of safeguards under this subsection or subsection 

24 (c)(2)(B), a group health plan, or a health insurance 

25 issuer offering health insurance coverage, shall be
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•S 2083 IS 

1 deemed to be in compliance with such subsections 

2 if such plan or issuer is in compliance with the 

3 standards promulgated by the Secretary of Health 

4 and Human Services under—

5 (A) part C of title XI of the Social Secu6 rity Act (42 U.S.C. 1320d et seq.); or 

7 (B) section 264(c) of Health Insurance 

8 Portability and Accountability Act of 1996 (42 

9 U.S.C. 1320d–2 note). 

10 (e) SPECIAL RULE IN CASE OF GENETIC INFORMA11 TION.—With respect to health insurance coverage offered 

12 by a health insurance issuer, the provisions of this section 

13 relating to genetic information (including information 

14 about a request for or the receipt of genetic services by 

15 an individual or a family member of such individual) shall 

16 not be construed to supersede any provision of State law 

17 that establishes, implements, or continues in effect a 

18 standard, requirement, or remedy that more completely—

19 (1) protects the confidentiality of genetic infor20 mation (including information about a request for or 

21 the receipt of genetic services by an individual or a 

22 family member of such individual) or the privacy of 

23 an individual or a family member of the individual 

24 with respect to genetic information (including infor25 mation about a request for or the receipt of genetic 
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•S 2083 IS 

1 services by the individual or a family member of 

2 such individual); or 

3 (2) prohibits discrimination on the basis of ge4 netic information than does this section. 

5 Subtitle D—Protecting the Doctor6 Patient Relationship 

7 SEC. 131. PROHIBITION OF INTERFERENCE WITH CERTAIN 

8 MEDICAL COMMUNICATIONS. 

9 (a) GENERAL RULE.—The provisions of any contract 

10 or agreement, or the operation of any contract or agree11 ment, between a group health plan or health insurance 

12 issuer in relation to health insurance coverage (including 

13 any partnership, association, or other organization that 

14 enters into or administers such a contract or agreement) 

15 and a health care provider (or group of health care pro16 viders) shall not prohibit or otherwise restrict a health 

17 care professional from advising such a participant, bene18 ficiary, or enrollee who is a patient of the professional 

19 about the health status of the individual or medical care 

20 or treatment for the individual’s condition or disease, re21 gardless of whether benefits for such care or treatment 

22 are provided under the plan or coverage, if the professional 

23 is acting within the lawful scope of practice. 
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•S 2083 IS 

1 (b) NULLIFICATION.—Any contract provision or 

2 agreement that restricts or prohibits medical communica3 tions in violation of subsection (a) shall be null and void. 

4 SEC. 132. PROHIBITION OF DISCRIMINATION AGAINST PRO5 VIDERS BASED ON LICENSURE. 

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

7 insurance issuer with respect to health insurance coverage, 

8 shall not discriminate with respect to participation or in9 demnification as to any provider who is acting within the 

10 scope of the provider’s license or certification under appli11 cable State law, solely on the basis of such license or cer12 tification. 

13 (b) CONSTRUCTION.—Subsection (a) shall not be con14 strued—

15 (1) as requiring the coverage under a group 

16 health plan or health insurance coverage of a par17 ticular benefit or service or to prohibit a plan or 

18 issuer from including providers only to the extent 

19 necessary to meet the needs of the plan’s or issuer’s 

20 participants, beneficiaries, or enrollees or from es21 tablishing any measure designed to maintain quality 

22 and control costs consistent with the responsibilities 

23 of the plan or issuer; 

24 (2) to override any State licensure or scope-of25 practice law; or 
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1 (3) as requiring a plan or issuer that offers net2 work coverage to include for participation every will3 ing provider who meets the terms and conditions of 

4 the plan or issuer. 

5 SEC. 133. PROHIBITION AGAINST IMPROPER INCENTIVE 

6 ARRANGEMENTS. 

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

8 insurance issuer offering health insurance coverage may 

9 not operate any physician incentive plan (as defined in 

10 subparagraph (B) of section 1876(i)(8) of the Social Secu11 rity Act) unless the requirements described in clauses (i), 

12 (ii)(I), and (iii) of subparagraph (A) of such section are 

13 met with respect to such a plan. 

14 (b) APPLICATION.—For purposes of carrying out 

15 paragraph (1), any reference in section 1876(i)(8) of the 

16 Social Security Act to the Secretary, an eligible organiza17 tion, or an individual enrolled with the organization shall 

18 be treated as a reference to the applicable authority, a 

19 group health plan or health insurance issuer, respectively, 

20 and a participant, beneficiary, or enrollee with the plan 

21 or organization, respectively. 

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

23 construed as prohibiting all capitation and similar ar24 rangements or all provider discount arrangements. 
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•S 2083 IS 

1 SEC. 134. PAYMENT OF CLAIMS. 

2 A group health plan, and a health insurance issuer 

3 offering group health insurance coverage, shall provide for 

4 prompt payment of claims submitted for health care serv5 ices or supplies furnished to a participant, beneficiary, or 

6 enrollee with respect to benefits covered by the plan or 

7 issuer, in a manner consistent with the provisions of sec8 tion 1842(c)(2) of the Social Security Act (42 U.S.C. 

9 1395u(c)(2)). 

10 SEC. 135. PROTECTION FOR PATIENT ADVOCACY. 

11 (a) PROTECTION FOR USE OF UTILIZATION REVIEW

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

13 health insurance issuer with respect to the provision of 

14 health insurance coverage, may not retaliate against a par15 ticipant, beneficiary, enrollee, or health care provider 

16 based on the participant’s, beneficiary’s, enrollee’s or pro17 vider’s use of, or participation in, a utilization review proc18 ess or a grievance process of the plan or issuer (including 

19 an internal or external review or appeal process) under 

20 this title. 

21 (b) PROTECTION FOR QUALITY ADVOCACY BY

22 HEALTH CARE PROFESSIONALS.—

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

24 health insurance issuer may not retaliate or dis25 criminate against a protected health care profes26 sional because the professional in good faith—
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•S 2083 IS 

1 (A) discloses information relating to the 

2 care, services, or conditions affecting one or 

3 more participants, beneficiaries, or enrollees of 

4 the plan or issuer to an appropriate public reg5 ulatory agency, an appropriate private accredi6 tation body, or appropriate management per7 sonnel of the plan or issuer; or 

8 (B) initiates, cooperates, or otherwise par9 ticipates in an investigation or proceeding by 

10 such an agency with respect to such care, serv11 ices, or conditions. 

12 If an institutional health care provider is a partici13 pating provider with such a plan or issuer or other14 wise receives payments for benefits provided by such 

15 a plan or issuer, the provisions of the previous sen16 tence shall apply to the provider in relation to care, 

17 services, or conditions affecting one or more patients 

18 within an institutional health care provider in the 

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

20 relation to care, services, or conditions provided to 

21 one or more participants, beneficiaries, or enrollees; 

22 and for purposes of applying this sentence, any ref23 erence to a plan or issuer is deemed a reference to 

24 the institutional health care provider. 
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•S 2083 IS 

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

2 paragraph (1), a protected health care professional 

3 is considered to be acting in good faith with respect 

4 to disclosure of information or participation if, with 

5 respect to the information disclosed as part of the 

6 action—

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

8 personal knowledge and is consistent with that 

9 degree of learning and skill ordinarily possessed 

10 by health care professionals with the same li11 censure or certification and the same experi12 ence; 

13 (B) the professional reasonably believes the 

14 information to be true; 

15 (C) the information evidences either a vio16 lation of a law, rule, or regulation, of an appli17 cable accreditation standard, or of a generally 

18 recognized professional or clinical standard or 

19 that a patient is in imminent hazard of loss of 

20 life or serious injury; and 

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

22 of paragraph (3), the professional has followed 

23 reasonable internal procedures of the plan, 

24 issuer, or institutional health care provider es-
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•S 2083 IS 

1 tablished for the purpose of addressing quality 

2 concerns before making the disclosure. 

3 (3) EXCEPTION AND SPECIAL RULE.—

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

5 does not protect disclosures that would violate 

6 Federal or State law or diminish or impair the 

7 rights of any person to the continued protection 

8 of confidentiality of communications provided 

9 by such law. 

10 (B) NOTICE OF INTERNAL PROCEDURES.—

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

12 apply unless the internal procedures involved 

13 are reasonably expected to be known to the 

14 health care professional involved. For purposes 

15 of this subparagraph, a health care professional 

16 is reasonably expected to know of internal pro17 cedures if those procedures have been made 

18 available to the professional through distribu19 tion or posting. 

20 (C) INTERNAL PROCEDURE EXCEPTION.—

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

22 not apply if—

23 (i) the disclosure relates to an immi24 nent hazard of loss of life or serious injury 

25 to a patient; 
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•S 2083 IS 

1 (ii) the disclosure is made to an ap2 propriate private accreditation body pursu3 ant to disclosure procedures established by 

4 the body; or 

5 (iii) the disclosure is in response to an 

6 inquiry made in an investigation or pro7 ceeding of an appropriate public regulatory 

8 agency and the information disclosed is 

9 limited to the scope of the investigation or 

10 proceeding. 

11 (4) ADDITIONAL CONSIDERATIONS.—It shall 

12 not be a violation of paragraph (1) to take an ad13 verse action against a protected health care profes14 sional if the plan, issuer, or provider taking the ad15 verse action involved demonstrates that it would 

16 have taken the same adverse action even in the ab17 sence of the activities protected under such para18 graph. 

19 (5) NOTICE.—A group health plan, health in20 surance issuer, and institutional health care provider 

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

22 the Secretary of Labor, setting forth excerpts from, 

23 or summaries of, the pertinent provisions of this 

24 subsection and information pertaining to enforce25 ment of such provisions. 
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•S 2083 IS 

1 (6) CONSTRUCTIONS.—

2 (A) DETERMINATIONS OF COVERAGE.—

3 Nothing in this subsection shall be construed to 

4 prohibit a plan or issuer from making a deter5 mination not to pay for a particular medical 

6 treatment or service or the services of a type of 

7 health care professional. 

8 (B) ENFORCEMENT OF PEER REVIEW PRO9 TOCOLS AND INTERNAL PROCEDURES.—Noth10 ing in this subsection shall be construed to pro11 hibit a plan, issuer, or provider from estab12 lishing and enforcing reasonable peer review or 

13 utilization review protocols or determining 

14 whether a protected health care professional has 

15 complied with those protocols or from estab16 lishing and enforcing internal procedures for 

17 the purpose of addressing quality concerns. 

18 (C) RELATION TO OTHER RIGHTS.—Noth19 ing in this subsection shall be construed to 

20 abridge rights of participants, beneficiaries, en21 rollees, and protected health care professionals 

22 under other applicable Federal or State laws. 

23 (7) PROTECTED HEALTH CARE PROFESSIONAL

24 DEFINED.—For purposes of this subsection, the 

25 term ‘‘protected health care professional’’ means an
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•S 2083 IS 

1 individual who is a licensed or certified health care 

2 professional and who—

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

4 health insurance issuer, is an employee of the 

5 plan or issuer or has a contract with the plan 

6 or issuer for provision of services for which ben7 efits are available under the plan or issuer; or 

8 (B) with respect to an institutional health 

9 care provider, is an employee of the provider or 

10 has a contract or other arrangement with the 

11 provider respecting the provision of health care 

12 services. 

13 Subtitle E—Definitions 

14 SEC. 151. DEFINITIONS. 

15 (a) INCORPORATION OF GENERAL DEFINITIONS.—

16 Except as otherwise provided, the provisions of section 

17 2791 of the Public Health Service Act shall apply for pur18 poses of this title in the same manner as they apply for 

19 purposes of title XXVII of such Act. 

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

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

22 Human Services, in consultation with the Secretary of 

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

24 Secretary of Health and Human Services in relation to 

25 carrying out this title under sections 2706 and 2751 of 
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•S 2083 IS 

1 the Public Health Service Act and the Secretary of Labor 

2 in relation to carrying out this title under section 713 of 

3 the Employee Retirement Income Security Act of 1974. 

4 (c) ADDITIONAL DEFINITIONS.—For purposes of this 

5 title: 

6 (1) APPLICABLE AUTHORITY.—The term ‘‘ap7 plicable authority’’ means—

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

9 Secretary of Health and Human Services and 

10 the Secretary of Labor; and 

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

12 with respect to a specific provision of this title, 

13 the applicable State authority (as defined in 

14 section 2791(d) of the Public Health Service 

15 Act), or the Secretary of Health and Human 

16 Services, if such Secretary is enforcing such 

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

18 2761(a)(2) of the Public Health Service Act. 

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

20 with respect to health insurance coverage offered by 

21 a health insurance issuer, an individual enrolled with 

22 the issuer to receive such coverage. 

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

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

25 section 733(a) of the Employee Retirement Income 
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•S 2083 IS 

1 Security Act of 1974, except that such term includes 

2 a employee welfare benefit plan treated as a group 

3 health plan under section 732(d) of such Act or de4 fined as such a plan under section 607(1) of such 

5 Act. 

6 (4) HEALTH CARE PROFESSIONAL.—The term 

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

8 is licensed, accredited, or certified under State law 

9 to provide specified health care services and who is 

10 operating within the scope of such licensure, accredi11 tation, or certification. 

12 (5) HEALTH CARE PROVIDER.—The term 

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

14 health care professional, as well as an institutional 

15 or other facility or agency that provides health care 

16 services and that is licensed, accredited, or certified 

17 to provide health care items and services under ap18 plicable State law. 

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

20 with respect to a group health plan or health insur21 ance issuer offering health insurance coverage, the 

22 participating health care professionals and providers 

23 through whom the plan or issuer provides health 

24 care items and services to participants, beneficiaries, 

25 or enrollees. 
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1 (7) NONPARTICIPATING.—The term ‘‘non2 participating’’ means, with respect to a health care 

3 provider that provides health care items and services 

4 to a participant, beneficiary, or enrollee under group 

5 health plan or health insurance coverage, a health 

6 care provider that is not a participating health care 

7 provider with respect to such items and services. 

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

9 means, with respect to a health care provider that 

10 provides health care items and services to a partici11 pant, beneficiary, or enrollee under group health 

12 plan or health insurance coverage offered by a 

13 health insurance issuer, a health care provider that 

14 furnishes such items and services under a contract 

15 or other arrangement with the plan or issuer. 

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

17 authorization’’ means the process of obtaining prior 

18 approval from a health insurance issuer or group 

19 health plan for the provision or coverage of medical 

20 services. 

21 (10) TERMS AND CONDITIONS.—The term 

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

23 group health plan or health insurance coverage, re24 quirements imposed under this title with respect to 

25 the plan or coverage. 
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•S 2083 IS 

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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•S 2083 IS 

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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•S 2083 IS 

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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•S 2083 IS 

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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•S 2083 IS 

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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•S 2083 IS 

1 the State’s interpretation of the State law in2 volved and the compliance of the law with a pa3 tient protection requirement. 

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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•S 2083 IS 

1 (A) PETITION PROCESS.—Effective on the 

2 date on which the provisions of this Act become 

3 effective, as provided for in section 501, 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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•S 2083 IS 

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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•S 2083 IS 

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. COVERAGE OF LIMITED SCOPE PLANS. 

18 Only for purposes of applying the requirements of 

19 this title under sections 2707 and 2753 of the Public 

20 Health Service Act and section 714 of the Employee Re21 tirement Income Security Act of 1974, section 

22 2791(c)(2)(A), and section 733(c)(2)(A) of the Employee 

23 Retirement Income Security Act of 1974 shall be deemed 

24 not to apply. 
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•S 2083 IS 

1 SEC. 155. REGULATIONS. 

2 The Secretaries of Health and Human Services and 

3 Labor shall issue such regulations as may be necessary 

4 or appropriate to carry out this title. Such regulations 

5 shall be issued consistent with section 104 of Health In6 surance Portability and Accountability Act of 1996. Such 

7 Secretaries may promulgate any interim final rules as the 

8 Secretaries determine are appropriate to carry out this 

9 title. 

10 SEC. 156. INCORPORATION INTO PLAN OR COVERAGE DOC11 UMENTS. 

12 The requirements of this title with respect to a group 

13 health plan or health insurance coverage are deemed to 

14 be incorporated into, and made a part of, such plan or 

15 the policy, certificate, or contract providing such coverage 

16 and are enforceable under law as if directly included in 

17 the documentation of such plan or such policy, certificate, 

18 or contract. 
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•S 2083 IS 

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 Bipartisan Pa15 tient Protection Act, and each health insurance issuer 

16 shall comply with patient protection requirements under 

17 such title with respect to group health insurance coverage 

18 it offers, and such requirements shall be deemed to be in19 corporated into this subsection.’’. 

20 (b) CONFORMING AMENDMENT.—Section 

21 2721(b)(2)(A) of such Act (42 U.S.C. 300gg–21(b)(2)(A)) 

22 is amended by inserting ‘‘(other than section 2707)’’ after 

23 ‘‘requirements of such subparts’’.
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•S 2083 IS 

1 SEC. 202. APPLICATION TO INDIVIDUAL HEALTH INSUR2 ANCE COVERAGE. 

3 Part B of title XXVII of the Public Health Service 

4 Act is amended by inserting after section 2752 the fol5 lowing new section: 

6 ‘‘SEC. 2753. PATIENT PROTECTION STANDARDS. 

7 ‘‘Each health insurance issuer shall comply with pa8 tient protection requirements under title I of the Bipar9 tisan Patient Protection Act with respect to individual 

10 health insurance coverage it offers, and such requirements 

11 shall be deemed to be incorporated into this subsection.’’. 

12 SEC. 203. COOPERATION BETWEEN FEDERAL AND STATE 

13 AUTHORITIES. 

14 Part C of title XXVII of the Public Health Service 

15 Act (42 U.S.C. 300gg–91 et seq.) is amended by adding 

16 at the end the following: 

17 ‘‘SEC. 2793. COOPERATION BETWEEN FEDERAL AND STATE 

18 AUTHORITIES. 

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

20 enter into an agreement with the Secretary for the delega21 tion to the State of some or all of the Secretary’s authority 

22 under this title to enforce the requirements applicable 

23 under title I of the Bipartisan Patient Protection Act with 

24 respect to health insurance coverage offered by a health 

25 insurance issuer and with respect to a group health plan 

26 that is a non-Federal governmental plan. 
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•S 2083 IS 

1 ‘‘(b) DELEGATIONS.—Any department, agency, or in2 strumentality of a State to which authority is delegated 

3 pursuant to an agreement entered into under this section 

4 may, if authorized under State law and to the extent con5 sistent with such agreement, exercise the powers of the 

6 Secretary under this title which relate to such authority.’’. 

7 SEC. 204. ELIMINATION OF OPTION OF NON-FEDERAL GOV8 ERNMENTAL PLANS TO BE EXCEPTED FROM 

9 REQUIREMENTS CONCERNING GENETIC IN10 FORMATION. 

11 Section 2721(b)(2) of the Public Health Service Act 

12 (42 U.S. C. 300gg–21(b)(2)) is amended—

13 (1) in subparagraph (A), by striking ‘‘If the 

14 plan sponsor’’ and inserting ‘‘Except as provided in 

15 subparagraph (D), if the plan sponsor’’; and 

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

17 ‘‘(D) ELECTION NOT APPLICABLE TO RE18 QUIREMENTS CONCERNING GENETIC INFORMA19 TION.—The election described in subparagraph 

20 (A) shall not be available with respect to the 

21 provisions of subsections (b), (c), and (d) of 

22 section 122 of the Bipartisan Patient Protec23 tion Act and the provisions of section 2702(b) 

24 to the extent that the subsections and section 

25 apply to genetic information (or information 
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•S 2083 IS 

1 about a request for or the receipt of genetic 

2 services by an individual or a family member of 

3 such individual).’’. 

4 TITLE III—APPLICATION OF PA5 TIENT PROTECTION STAND6 ARDS TO FEDERAL HEALTH 

7 CARE PROGRAMS 

8 SEC. 301. APPLICATION OF PATIENT PROTECTION STAND9 ARDS TO FEDERAL HEALTH CARE PRO10 GRAMS. 

11 (a) APPLICATION OF STANDARDS.—

12 (1) IN GENERAL.—Each Federal health care 

13 program shall comply with the patient protection re14 quirements under title I, and such requirements 

15 shall be deemed to be incorporated into this section. 

16 (2) CAUSE OF ACTION RELATING TO PROVISION

17 OF HEALTH BENEFITS.—Any individual who receives 

18 a health care item or service under a Federal health 

19 care program shall have a cause of action against 

20 the Federal Government under sections 502(n) and 

21 514(d) of the Employee Retirement Income Security 

22 Act of 1974, and the provisions of such sections 

23 shall be deemed to be incorporated into this section. 

24 (3) RULES OF CONSTRUCTION.—For purposes 

25 of this subsection—
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•S 2083 IS 

1 (A) each Federal health care program shall 

2 be deemed to be a group health plan; 

3 (B) the Federal Government shall be 

4 deemed to be the plan sponsor of each Federal 

5 health care program; and 

6 (C) each individual eligible for benefits 

7 under a Federal health care program shall be 

8 deemed to be a participant, beneficiary, or en9 rollee under that program. 

10 (b) FEDERAL HEALTH CARE PROGRAM DEFINED.—

11 In this section, the term ‘‘Federal health care program’’ 

12 has the meaning given that term under section 1128B(f) 

13 of the Social Security Act (42 U.S.C. 1320a–7b) except 

14 that, for purposes of this section, such term includes the 

15 Federal employees health benefits program established 

16 under chapter 89 of title 5, United States Code.
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•S 2083 IS 

1 TITLE IV—AMENDMENTS TO THE 

2 EMPLOYEE RETIREMENT IN3 COME SECURITY ACT OF 1974

4 SEC. 401. APPLICATION OF PATIENT PROTECTION STAND5 ARDS TO GROUP HEALTH PLANS AND GROUP 

6 HEALTH INSURANCE COVERAGE UNDER THE 

7 EMPLOYEE RETIREMENT INCOME SECURITY 

8 ACT OF 1974. 

9 Subpart B of part 7 of subtitle B of title I of the 

10 Employee Retirement Income Security Act of 1974 is 

11 amended by adding at the end the following new section: 

12 ‘‘SEC. 714. PATIENT PROTECTION STANDARDS. 

13 ‘‘(a) IN GENERAL.—Subject to subsection (b), a 

14 group health plan (and a health insurance issuer offering 

15 group health insurance coverage in connection with such 

16 a plan) shall comply with the requirements of title I of 

17 the Bipartisan Patient Protection Act (as in effect as of 

18 the date of the enactment of such Act), and such require19 ments shall be deemed to be incorporated into this sub20 section. 

21 ‘‘(b) PLAN SATISFACTION OF CERTAIN REQUIRE22 MENTS.—

23 ‘‘(1) SATISFACTION OF CERTAIN REQUIRE24 MENTS THROUGH INSURANCE.—For purposes of 

25 subsection (a), insofar as a group health plan pro-
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•S 2083 IS 

1 vides benefits in the form of health insurance cov2 erage through a health insurance issuer, the plan 

3 shall be treated as meeting the following require4 ments of title I of the Bipartisan Patient Protection 

5 Act with respect to such benefits and not be consid6 ered as failing to meet such requirements because of 

7 a failure of the issuer to meet such requirements so 

8 long as the plan sponsor or its representatives did 

9 not cause such failure by the issuer: 

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

11 choice option). 

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

13 health care professional). 

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

15 emergency care). 

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

17 to specialists). 

18 ‘‘(E) Section 115 (relating to patient ac19 cess to obstetrical and gynecological care). 

20 ‘‘(F) Section 116 (relating to access to pe21 diatric care). 

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

23 care), but only insofar as a replacement issuer 

24 assumes the obligation for continuity of care. 
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•S 2083 IS 

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

2 needed prescription drugs). 

3 ‘‘(I) Section 119 (relating to coverage for 

4 individuals participating in approved clinical 

5 trials). 

6 ‘‘(J) Section 120 (relating to required cov7 erage for minimum hospital stay for 

8 mastectomies and lymph node dissections for 

9 the treatment of breast cancer and coverage for 

10 secondary consultations). 

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

12 claims). 

13 ‘‘(2) INFORMATION.—With respect to informa14 tion required to be provided or made available under 

15 section 121 of the Bipartisan Patient Protection 

16 Act, in the case of a group health plan that provides 

17 benefits in the form of health insurance coverage 

18 through a health insurance issuer, the Secretary 

19 shall determine the circumstances under which the 

20 plan is not required to provide or make available the 

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

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

23 issuer is obligated to provide and make available (or 

24 provides and makes available) such information. 
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•S 2083 IS 

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

2 internal appeals process required to be established 

3 under section 103 of such Act, in the case of a 

4 group health plan that provides benefits in the form 

5 of health insurance coverage through a health insur6 ance issuer, the Secretary shall determine the cir7 cumstances under which the plan is not required to 

8 provide for such process and system (and is not lia9 ble for the issuer’s failure to provide for such proc10 ess and system), if the issuer is obligated to provide 

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

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

13 of the Secretary, insofar as a group health plan en14 ters into a contract with a qualified external appeal 

15 entity for the conduct of external appeal activities in 

16 accordance with section 104 of such Act, the plan 

17 shall be treated as meeting the requirement of such 

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

19 meet any requirements under such section. 

20 ‘‘(5) APPLICATION TO PROHIBITIONS.—Pursu21 ant to rules of the Secretary, if a health insurance 

22 issuer offers health insurance coverage in connection 

23 with a group health plan and takes an action in vio24 lation of any of the following sections of the Bipar25 tisan Patient Protection Act, the group health plan 
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1 shall not be liable for such violation unless the plan 

2 caused such violation: 

3 ‘‘(A) Section 131 (relating to prohibition of 

4 interference with certain medical communica5 tions). 

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

7 of discrimination against providers based on li8 censure). 

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

10 against improper incentive arrangements). 

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

12 for patient advocacy). 

13 ‘‘(6) CONSTRUCTION.—Nothing in this sub14 section shall be construed to affect or modify the re15 sponsibilities of the fiduciaries of a group health 

16 plan under part 4 of subtitle B. 

17 ‘‘(7) TREATMENT OF SUBSTANTIALLY COMPLI18 ANT STATE LAWS.—For purposes of applying this 

19 subsection, any reference in this subsection to a re20 quirement in a section or other provision in the Bi21 partisan Patient Protection Act with respect to a 

22 health insurance issuer is deemed to include a ref23 erence to a requirement under a State law that sub24 stantially complies (as determined under section
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•S 2083 IS 

1 152(c) of such Act) with the requirement in such 

2 section or other provisions. 

3 ‘‘(8) APPLICATION TO CERTAIN PROHIBITIONS

4 AGAINST RETALIATION.—With respect to compliance 

5 with the requirements of section 135(b)(1) of the Bi6 partisan Patient Protection Act, for purposes of this 

7 subtitle the term ‘group health plan’ is deemed to in8 clude a reference to an institutional health care pro9 vider. 

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

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

12 professional who believes that the professional has 

13 been retaliated or discriminated against in violation 

14 of section 135(b)(1) of the Bipartisan Patient Pro15 tection Act may file with the Secretary a complaint 

16 within 180 days of the date of the alleged retaliation 

17 or discrimination. 

18 ‘‘(2) INVESTIGATION.—The Secretary shall in19 vestigate such complaints and shall determine if a 

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

21 shall issue an order to ensure that the protected 

22 health care professional does not suffer any loss of 

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

24 issuer, or provider involved, as a result of the viola25 tion found by the Secretary. 
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•S 2083 IS 

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

2 shall issue regulations to coordinate the requirements on 

3 group health plans and health insurance issuers under this 

4 section with the requirements imposed under the other 

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

6 clarify the rights of participants and beneficiaries with re7 spect to information that is required to be provided, such 

8 regulations shall coordinate the information disclosure re9 quirements under section 121 of the Bipartisan Patient 

10 Protection Act with the reporting and disclosure require11 ments imposed under part 1, so long as such coordination 

12 does not result in any reduction in the information that 

13 would otherwise be provided to participants and bene14 ficiaries.’’. 

15 (b) SATISFACTION OF ERISA CLAIMS PROCEDURE

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

17 1133) is amended by inserting ‘‘(a)’’ after ‘‘SEC. 503.’’ 

18 and by adding at the end the following new subsection: 

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

20 in section 733) compliance with the requirements of sub21 title A of title I of the Bipartisan Patient Protection Act, 

22 and compliance with regulations promulgated by the Sec23 retary, in the case of a claims denial shall be deemed com24 pliance with subsection (a) with respect to such claims de25 nial.’’. 
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•S 2083 IS 

1 (c) CONFORMING AMENDMENTS.—(1) Section 732(a) 

2 of such Act (29 U.S.C. 1185(a)) is amended by striking 

3 ‘‘section 711’’ and inserting ‘‘sections 711 and 714’’. 

4 (2) The table of contents in section 1 of such Act 

5 is amended by inserting after the item relating to section 

6 713 the following new item:

‘‘Sec. 714. Patient protection standards.’’.

7 (3) Section 502(b)(3) of such Act (29 U.S.C. 

8 1132(b)(3)) is amended by inserting ‘‘(other than section 

9 135(b))’’ after ‘‘part 7’’. 

10 SEC. 402. AVAILABILITY OF CIVIL REMEDIES. 

11 (a) AVAILABILITY OF FEDERAL CIVIL REMEDIES IN

12 CASES NOT INVOLVING MEDICALLY REVIEWABLE DECI13 SIONS.—

14 (1) IN GENERAL.—Section 502 of the Employee 

15 Retirement Income Security Act of 1974 (29 U.S.C. 

16 1132) is amended by adding at the end the following 

17 new subsections: 

18 ‘‘(n) CAUSE OF ACTION RELATING TO PROVISION OF

19 HEALTH BENEFITS.—

20 ‘‘(1) IN GENERAL.—In any case in which—

21 ‘‘(A) a person who is a fiduciary of a 

22 group health plan, a health insurance issuer of23 fering health insurance coverage in connection 

24 with the plan, or an agent of the plan, issuer, 

25 or plan sponsor upon consideration of a claim 
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•S 2083 IS 

1 for benefits of a participant or beneficiary 

2 under section 102 of the Bipartisan Patient 

3 Protection Act of 2004 (relating to procedures 

4 for initial claims for benefits and prior author5 ization determinations) or upon review of a de6 nial of such a claim under section 103 of such 

7 Act (relating to internal appeal of a denial of 

8 a claim for benefits), fails to exercise ordinary 

9 care in making a decision—

10 ‘‘(i) regarding whether an item or 

11 service is covered under the terms and con12 ditions of the plan or coverage, 

13 ‘‘(ii) regarding whether an individual 

14 is a participant or beneficiary who is en15 rolled under the terms and conditions of 

16 the plan or coverage (including the applica17 bility of any waiting period under the plan 

18 or coverage), or 

19 ‘‘(iii) as to the application of cost20 sharing requirements or the application of 

21 a specific exclusion or express limitation on 

22 the amount, duration, or scope of coverage 

23 of items or services under the terms and 

24 conditions of the plan or coverage, and 
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•S 2083 IS 

1 ‘‘(B) such failure is a proximate cause of 

2 personal injury to, or the death of, the partici3 pant or beneficiary—

4 such plan, plan sponsor or issuer shall be liable to 

5 the participant or beneficiary (or the estate of such 

6 participant or beneficiary) for economic and non7 economic damages (but not exemplary or punitive 

8 damages) in connection with such personal injury or 

9 death. 

10 ‘‘(2) CAUSE OF ACTION MUST NOT INVOLVE

11 MEDICALLY REVIEWABLE DECISION.—

12 ‘‘(A) IN GENERAL.—A cause of action is 

13 established under paragraph (1)(A) only if the 

14 decision referred to in paragraph (1)(A) does 

15 not include a medically reviewable decision. 

16 ‘‘(B) MEDICALLY REVIEWABLE DECI17 SION.—For purposes of this subsection, the 

18 term ‘medically reviewable decision’ means a de19 nial of a claim for benefits under the plan 

20 which is described in section 104(d)(2) of the 

21 Bipartisan Patient Protection Act of 2004 (re22 lating to medically reviewable decisions). 

23 ‘‘(3) LIMITATION REGARDING CERTAIN TYPES

24 OF ACTIONS SAVED FROM PREEMPTION OF STATE

25 LAW.—A cause of action is not established under
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•S 2083 IS 

1 paragraph (1)(A) in connection with a failure de2 scribed in paragraph (1)(A) to the extent that a 

3 cause of action under State law (as defined in sec4 tion 514(c)) for such failure would not be preempted 

5 under section 514. 

6 ‘‘(4) DEFINITIONS.—For purposes of this sub7 section.—

8 ‘‘(A) ORDINARY CARE.—The term ‘ordi9 nary care’ means, with respect to a determina10 tion on a claim for benefits, that degree of care, 

11 skill, and diligence that a reasonable and pru12 dent individual would exercise in making a fair 

13 determination on a claim for benefits of like 

14 kind to the claims involved. 

15 ‘‘(B) PERSONAL INJURY.—The term ‘per16 sonal injury’ means a physical injury and in17 cludes an injury arising out of the treatment 

18 (or failure to treat) a mental illness or disease. 

19 ‘‘(C) CLAIM FOR BENEFITS; DENIAL.—The 

20 terms ‘claim for benefits’ and ‘denial of a claim 

21 for benefits’ have the meanings provided such 

22 terms in section 102(e) of the Bipartisan Pa23 tient Protection Act of 2004. 

24 ‘‘(D) TERMS AND CONDITIONS.—The term 

25 ‘terms and conditions’ includes, with respect to 
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•S 2083 IS 

1 a group health plan or health insurance cov2 erage, requirements imposed under title I of the 

3 Bipartisan Patient Protection Act of 2004. 

4 ‘‘(E) GROUP HEALTH PLAN AND OTHER

5 RELATED TERMS.—The provisions of sections 

6 732(d) and 733 apply for purposes of this sub7 section in the same manner as they apply for 

8 purposes of part 7, except that the term ‘group 

9 health plan’ includes a group health plan (as 

10 defined in section 607(1)). 

11 ‘‘(5) EXCLUSION OF EMPLOYERS AND OTHER

12 PLAN SPONSORS.—

13 ‘‘(A) CAUSES OF ACTION AGAINST EM14 PLOYERS AND PLAN SPONSORS PRECLUDED.—

15 Subject to subparagraph (B), paragraph (1)(A) 

16 does not authorize a cause of action against an 

17 employer or other plan sponsor maintaining the 

18 plan (or against an employee of such an em19 ployer or sponsor acting within the scope of em20 ployment). 

21 ‘‘(B) CERTAIN CAUSES OF ACTION PER22 MITTED.—Notwithstanding subparagraph (A), 

23 a cause of action may arise against an employer 

24 or other plan sponsor (or against an employee 

25 of such an employer or sponsor acting within 
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•S 2083 IS 

1 the scope of employment) under paragraph 

2 (1)(A), to the extent there was direct participa3 tion by the employer or other plan sponsor (or 

4 employee) in the decision of the plan under sec5 tion 102 of the Bipartisan Patient Protection 

6 Act of 2004 upon consideration of a claim for 

7 benefits or under section 103 of such Act upon 

8 review of a denial of a claim for benefits. 

9 ‘‘(C) DIRECT PARTICIPATION.—

10 ‘‘(i) IN GENERAL.—For purposes of 

11 subparagraph (B), the term ‘direct partici12 pation’ means, in connection with a deci13 sion described in paragraph (1)(A), the ac14 tual making of such decision or the actual 

15 exercise of control in making such decision. 

16 ‘‘(ii) RULES OF CONSTRUCTION.—For 

17 purposes of clause (i), the employer or plan 

18 sponsor (or employee) shall not be con19 strued to be engaged in direct participation 

20 because of any form of decisionmaking or 

21 other conduct that is merely collateral or 

22 precedent to the decision described in 

23 paragraph (1)(A) on a particular claim for 

24 benefits of a participant or beneficiary, in25 cluding (but not limited to)—
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•S 2083 IS 

1 ‘‘(I) any participation by the em2 ployer or other plan sponsor (or em3 ployee) in the selection of the group 

4 health plan or health insurance cov5 erage involved or the third party ad6 ministrator or other agent; 

7 ‘‘(II) any engagement by the em8 ployer or other plan sponsor (or em9 ployee) in any cost-benefit analysis 

10 undertaken in connection with the se11 lection of, or continued maintenance 

12 of, the plan or coverage involved; 

13 ‘‘(III) any participation by the 

14 employer or other plan sponsor (or 

15 employee) in the process of creating, 

16 continuing, modifying, or terminating 

17 the plan or any benefit under the 

18 plan, if such process was not substan19 tially focused solely on the particular 

20 situation of the participant or bene21 ficiary referred to in paragraph 

22 (1)(A); and 

23 ‘‘(IV) any participation by the 

24 employer or other plan sponsor (or 

25 employee) in the design of any benefit 
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•S 2083 IS 

1 under the plan, including the amount 

2 of copayment and limits connected 

3 with such benefit. 

4 ‘‘(iii) IRRELEVANCE OF CERTAIN COL5 LATERAL EFFORTS MADE BY EMPLOYER

6 OR PLAN SPONSOR.—For purposes of this 

7 subparagraph, an employer or plan sponsor 

8 shall not be treated as engaged in direct 

9 participation in a decision with respect to 

10 any claim for benefits or denial thereof in 

11 the case of any particular participant or 

12 beneficiary solely by reason of—

13 ‘‘(I) any efforts that may have 

14 been made by the employer or plan 

15 sponsor to advocate for authorization 

16 of coverage for that or any other par17 ticipant or beneficiary (or any group 

18 of participants or beneficiaries), or 

19 ‘‘(II) any provision that may 

20 have been made by the employer or 

21 plan sponsor for benefits which are 

22 not covered under the terms and con23 ditions of the plan for that or any 

24 other participant or beneficiary (or
173

•S 2083 IS 

1 any group of participants or bene2 ficiaries). 

3 ‘‘(D) APPLICATION TO CERTAIN PLANS.—

4 ‘‘(i) IN GENERAL.—Notwithstanding 

5 any other provision of this subsection, no 

6 group health plan described in clause (ii) 

7 shall be liable under paragraph (1) for the 

8 performance of, or the failure to perform, 

9 any non-medically reviewable duty under 

10 the plan. 

11 ‘‘(ii) DEFINITION.—A group health 

12 plan described in this clause is—

13 ‘‘(I) a group health plan that is 

14 self-insured and self administered by 

15 an employer (including an employee of 

16 such an employer acting within the 

17 scope of employment); or 

18 ‘‘(II) a multiemployer plan as de19 fined in section 3(37)(A) (including 

20 an employee of a contributing em21 ployer or of the plan, or a fiduciary of 

22 the plan, acting within the scope of 

23 employment or fiduciary responsi24 bility) that is self-insured and self-ad25 ministered. 
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•S 2083 IS 

1 ‘‘(6) EXCLUSION OF PHYSICIANS AND OTHER

2 HEALTH CARE PROFESSIONALS.—

3 ‘‘(A) IN GENERAL.—No treating physician 

4 or other treating health care professional of the 

5 participant or beneficiary, and no person acting 

6 under the direction of such a physician or 

7 health care professional, shall be liable under 

8 paragraph (1) for the performance of, or the 

9 failure to perform, any non-medically reviewable 

10 duty of the plan, the plan sponsor, or any 

11 health insurance issuer offering health insur12 ance coverage in connection with the plan. 

13 ‘‘(B) DEFINITIONS.—For purposes of sub14 paragraph (A)—

15 ‘‘(i) HEALTH CARE PROFESSIONAL.—

16 The term ‘health care professional’ means 

17 an individual who is licensed, accredited, or 

18 certified under State law to provide speci19 fied health care services and who is oper20 ating within the scope of such licensure, 

21 accreditation, or certification. 

22 ‘‘(ii) NON-MEDICALLY REVIEWABLE

23 DUTY.—The term ‘non-medically review24 able duty’ means a duty the discharge of 
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•S 2083 IS 

1 which does not include the making of a 

2 medically reviewable decision. 

3 ‘‘(7) EXCLUSION OF HOSPITALS.—No treating 

4 hospital of the participant or beneficiary shall be lia5 ble under paragraph (1) for the performance of, or 

6 the failure to perform, any non-medically reviewable 

7 duty (as defined in paragraph (6)(B)(ii)) of the 

8 plan, the plan sponsor, or any health insurance 

9 issuer offering health insurance coverage in connec10 tion with the plan. 

11 ‘‘(8) RULE OF CONSTRUCTION RELATING TO

12 EXCLUSION FROM LIABILITY OF PHYSICIANS, 

13 HEALTH CARE PROFESSIONALS, AND HOSPITALS.—

14 Nothing in paragraph (6) or (7) shall be construed 

15 to limit the liability (whether direct or vicarious) of 

16 the plan, the plan sponsor, or any health insurance 

17 issuer offering health insurance coverage in connec18 tion with the plan. 

19 ‘‘(9) REQUIREMENT OF EXHAUSTION.—

20 ‘‘(A) IN GENERAL.—A cause of action may 

21 not be brought under paragraph (1) in connec22 tion with any denial of a claim for benefits of 

23 any individual until all administrative processes 

24 under sections 102 and 103 of the Bipartisan 
176

•S 2083 IS 

1 Patient Protection Act of 2004 (if applicable) 

2 have been exhausted. 

3 ‘‘(B) EXCEPTION FOR NEEDED CARE.—A 

4 participant or beneficiary may seek relief exclu5 sively in Federal court under subsection 

6 502(a)(1)(B) prior to the exhaustion of admin7 istrative remedies under sections 102, 103, or 

8 104 of the Bipartisan Patient Protection Act 

9 (as required under subparagraph (A)) if it is 

10 demonstrated to the court that the exhaustion 

11 of such remedies would cause irreparable harm 

12 to the health of the participant or beneficiary. 

13 Notwithstanding the awarding of relief under 

14 subsection 502(a)(1)(B) pursuant to this sub15 paragraph, no relief shall be available as a re16 sult of, or arising under, paragraph (1)(A) or 

17 paragraph (10)(B), with respect to a partici18 pant or beneficiary, unless the requirements of 

19 subparagraph (A) are met. 

20 ‘‘(C) RECEIPT OF BENEFITS DURING AP21 PEALS PROCESS.—Receipt by the participant or 

22 beneficiary of the benefits involved in the claim 

23 for benefits during the pendency of any admin24 istrative processes referred to in subparagraph 
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•S 2083 IS 

1 (A) or of any action commenced under this sub2 section—

3 ‘‘(i) shall not preclude continuation of 

4 all such administrative processes to their 

5 conclusion if so moved by any party, and 

6 ‘‘(ii) shall not preclude any liability 

7 under subsection (a)(1)(C) and this sub8 section in connection with such claim. 

9 The court in any action commenced under this 

10 subsection shall take into account any receipt of 

11 benefits during such administrative processes or 

12 such action in determining the amount of the 

13 damages awarded. 

14 ‘‘(D) ADMISSIBLE.—Any determination 

15 made by a reviewer in an administrative pro16 ceeding under section 103 of the Bipartisan Pa17 tient Protection Act of 2004 shall be admissible 

18 in any Federal court proceeding and shall be 

19 presented to the trier of fact. 

20 ‘‘(10) STATUTORY DAMAGES.—

21 ‘‘(A) IN GENERAL.—The remedies set 

22 forth in this subsection (n) shall be the exclu23 sive remedies for causes of action brought 

24 under this subsection.
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•S 2083 IS 

1 ‘‘(B) ASSESSMENT OF CIVIL PENALTIES.—

2 In addition to the remedies provided for in 

3 paragraph (1) (relating to the failure to provide 

4 contract benefits in accordance with the plan), 

5 a civil assessment, in an amount not to exceed 

6 $5,000,000, payable to the claimant may be 

7 awarded in any action under such paragraph if 

8 the claimant establishes by clear and convincing 

9 evidence that the alleged conduct carried out by 

10 the defendant demonstrated bad faith and fla11 grant disregard for the rights of the participant 

12 or beneficiary under the plan and was a proxi13 mate cause of the personal injury or death that 

14 is the subject of the claim. 

15 ‘‘(11) LIMITATION ON ATTORNEYS’ FEES.—

16 ‘‘(A) IN GENERAL.—Notwithstanding any 

17 other provision of law, or any arrangement, 

18 agreement, or contract regarding an attorney’s 

19 fee, the amount of an attorney’s contingency fee 

20 allowable for a cause of action brought pursuant to this subsection shall not exceed 1 21 ⁄3 of the 

22 total amount of the plaintiff’s recovery (not in23 cluding the reimbursement of actual out-of24 pocket expenses of the attorney). 
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•S 2083 IS 

1 ‘‘(B) DETERMINATION BY DISTRICT

2 COURT.—The last Federal district court in 

3 which the action was pending upon the final 

4 disposition, including all appeals, of the action 

5 shall have jurisdiction to review the attorney’s 

6 fee to ensure that the fee is a reasonable one. 

7 ‘‘(12) LIMITATION OF ACTION.—Paragraph (1) 

8 shall not apply in connection with any action com9 menced after 3 years after the later of—

10 ‘‘(A) the date on which the plaintiff first 

11 knew, or reasonably should have known, of the 

12 personal injury or death resulting from the fail13 ure described in paragraph (1), or 

14 ‘‘(B) the date as of which the requirements 

15 of paragraph (9) are first met. 

16 ‘‘(13) TOLLING PROVISION.—The statute of 

17 limitations for any cause of action arising under 

18 State law relating to a denial of a claim for benefits 

19 that is the subject of an action brought in Federal 

20 court under this subsection shall be tolled until such 

21 time as the Federal court makes a final disposition, 

22 including all appeals, of whether such claim should 

23 properly be within the jurisdiction of the Federal 

24 court. The tolling period shall be determined by the 
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•S 2083 IS 

1 applicable Federal or State law, whichever period is 

2 greater. 

3 ‘‘(14) PURCHASE OF INSURANCE TO COVER LI4 ABILITY.—Nothing in section 410 shall be construed 

5 to preclude the purchase by a group health plan of 

6 insurance to cover any liability or losses arising 

7 under a cause of action under subsection (a)(1)(C) 

8 and this subsection. 

9 ‘‘(15) EXCLUSION OF DIRECTED RECORD10 KEEPERS.—

11 ‘‘(A) IN GENERAL.—Subject to subpara12 graph (C), paragraph (1) shall not apply with 

13 respect to a directed recordkeeper in connection 

14 with a group health plan. 

15 ‘‘(B) DIRECTED RECORDKEEPER.—For 

16 purposes of this paragraph, the term ‘directed 

17 recordkeeper’ means, in connection with a 

18 group health plan, a person engaged in directed 

19 recordkeeping activities pursuant to the specific 

20 instructions of the plan or the employer or 

21 other plan sponsor, including the distribution of 

22 enrollment information and distribution of dis23 closure materials under this Act or title I of the 

24 Bipartisan Patient Protection Act of 2004 and 
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•S 2083 IS 

1 whose duties do not include making decisions 

2 on claims for benefits. 

3 ‘‘(C) LIMITATION.—Subparagraph (A) 

4 does not apply in connection with any directed 

5 recordkeeper to the extent that the directed rec6 ordkeeper fails to follow the specific instruction 

7 of the plan or the employer or other plan spon8 sor. 

9 ‘‘(16) EXCLUSION OF HEALTH INSURANCE

10 AGENTS.—Paragraph (1) does not apply with re11 spect to a person whose sole involvement with the 

12 group health plan is providing advice or administra13 tive services to the employer or other plan sponsor 

14 relating to the selection of health insurance coverage 

15 offered in connection with the plan. 

16 ‘‘(17) NO EFFECT ON STATE LAW.—No provi17 sion of State law (as defined in section 514(c)(1)) 

18 shall be treated as superseded or otherwise altered, 

19 amended, modified, invalidated, or impaired by rea20 son of the provisions of subsection (a)(1)(C) and this 

21 subsection. 

22 ‘‘(18) RELIEF FROM LIABILITY FOR EMPLOYER

23 OR OTHER PLAN SPONSOR BY MEANS OF DES24 IGNATED DECISIONMAKER.—
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•S 2083 IS 

1 ‘‘(A) IN GENERAL.—Notwithstanding the 

2 direct participation (as defined in paragraph 

3 (5)(C)(i)) of an employer or plan sponsor, in 

4 any case in which there is deemed to be a des5 ignated decisionmaker under subparagraph (B) 

6 that meets the requirements of subsection 

7 (o)(1) for an employer or other plan sponsor—

8 ‘‘(i) all liability of such employer or 

9 plan sponsor (and any employee thereof 

10 acting within the scope of employment) 

11 under this subsection in connection with 

12 any participant or beneficiary shall be 

13 transferred to, and assumed by, the des14 ignated decisionmaker, and 

15 ‘‘(ii) with respect to such liability, the 

16 designated decisionmaker shall be sub17 stituted for the employer or plan sponsor 

18 (or employee) in the action and may not 

19 raise any defense that the employer or plan 

20 sponsor (or employee) could not raise if 

21 such a decisionmaker were not so deemed. 

22 ‘‘(B) AUTOMATIC DESIGNATION.—A health 

23 insurance issuer shall be deemed to be a des24 ignated decisionmaker for purposes of subpara25 graph (A) with respect to the participants and
183

•S 2083 IS 

1 beneficiaries of an employer or plan sponsor, 

2 whether or not the employer or plan sponsor 

3 makes such a designation, and shall be deemed 

4 to have assumed unconditionally all liability of 

5 the employer or plan sponsor under such des6 ignation in accordance with subsection (o), un7 less the employer or plan sponsor affirmatively 

8 enters into a contract to prevent the service of 

9 the designated decisionmaker. 

10 ‘‘(19) PREVIOUSLY PROVIDED SERVICES.—

11 ‘‘(A) IN GENERAL.—Except as provided in 

12 this paragraph, a cause of action shall not arise 

13 under paragraph (1) where the denial involved 

14 relates to an item or service that has already 

15 been fully provided to the participant or bene16 ficiary under the plan or coverage and the claim 

17 relates solely to the subsequent denial of pay18 ment for the provision of such item or service. 

19 ‘‘(B) EXCEPTION.—Nothing in subpara20 graph (A) shall be construed to—

21 ‘‘(i) prohibit a cause of action under 

22 paragraph (1) where the nonpayment in23 volved results in the participant or bene24 ficiary being unable to receive further 

25 items or services that are directly related 
184

•S 2083 IS 

1 to the item or service involved in the denial 

2 referred to in subparagraph (A) or that 

3 are part of a continuing treatment or se4 ries of procedures; 

5 ‘‘(ii) prohibit a cause of action under 

6 paragraph (1) relating to quality of care; 

7 or 

8 ‘‘(iii) limit liability that otherwise 

9 would arise from the provision of the item 

10 or services or the performance of a medical 

11 procedure. 

12 ‘‘(20) EXEMPTION FROM PERSONAL LIABILITY

13 FOR INDIVIDUAL MEMBERS OF BOARDS OF DIREC14 TORS, JOINT BOARDS OF TRUSTEES, ETC.—Any indi15 vidual who is—

16 ‘‘(A) a member of a board of directors of 

17 an employer or plan sponsor; or 

18 ‘‘(B) a member of an association, com19 mittee, employee organization, joint board of 

20 trustees, or other similar group of representa21 tives of the entities that are the plan sponsor 

22 of plan maintained by two or more employers 

23 and one or more employee organizations; 

24 shall not be personally liable under this subsection 

25 for conduct that is within the scope of employment 
185

•S 2083 IS 

1 of the individuals unless the individual acts in a 

2 fraudulent manner for personal enrichment. 

3 ‘‘(o) REQUIREMENTS FOR DESIGNATED DECISION4 MAKERS OF GROUP HEALTH

5 ‘‘(1) IN GENERAL.—For purposes of subsection 

6 (n)(18) and section 514(d)(9), a designated decision7 maker meets the requirements of this paragraph 

8 with respect to any participant or beneficiary if—

9 ‘‘(A) such designation is in such form as 

10 may be prescribed in regulations of the Sec11 retary, 

12 ‘‘(B) the designated decisionmaker—

13 ‘‘(i) meets the requirements of para14 graph (2), 

15 ‘‘(ii) assumes unconditionally all liabil16 ity of the employer or plan sponsor in17 volved (and any employee thereof acting 

18 within the scope of employment) either 

19 arising under subsection (n) or arising in 

20 a cause of action permitted under section 

21 514(d) in connection with actions (and 

22 failures to act) of the employer or plan 

23 sponsor (or employee) occurring during the 

24 period in which the designation under sub25 section (n)(18) or section 514(d)(9) is in 
186

•S 2083 IS 

1 effect relating to such participant and ben2 eficiary, 

3 ‘‘(iii) agrees to be substituted for the 

4 employer or plan sponsor (or employee) in 

5 the action and not to raise any defense 

6 with respect to such liability that the em7 ployer or plan sponsor (or employee) may 

8 not raise, and 

9 ‘‘(iv) where paragraph (2)(B) applies, 

10 assumes unconditionally the exclusive au11 thority under the group health plan to 

12 make medically reviewable decisions under 

13 the plan with respect to such participant 

14 or beneficiary, and 

15 ‘‘(C) the designated decisionmaker and the 

16 participants and beneficiaries for whom the de17 cisionmaker has assumed liability are identified 

18 in the written instrument required under sec19 tion 402(a) and as required under section 

20 121(b)(19) of the Bipartisan Patient Protection 

21 Act. 

22 Any liability assumed by a designated decisionmaker 

23 pursuant to this subsection shall be in addition to 

24 any liability that it may otherwise have under appli25 cable law.
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•S 2083 IS 

1 ‘‘(2) QUALIFICATIONS FOR DESIGNATED DECI2 SIONMAKERS.—

3 ‘‘(A) IN GENERAL.—Subject to subpara4 graph (B), an entity is qualified under this 

5 paragraph to serve as a designated decision6 maker with respect to a group health plan if the 

7 entity has the ability to assume the liability de8 scribed in paragraph (1) with respect to partici9 pants and beneficiaries under such plan, includ10 ing requirements relating to the financial obli11 gation for timely satisfying the assumed liabil12 ity, and maintains with the plan sponsor and 

13 the Secretary certification of such ability. Such 

14 certification shall be provided to the plan spon15 sor or named fiduciary and to the Secretary 

16 upon designation under subsection (n)(18)(B) 

17 or section 517(d)(9)(B) and not less frequently 

18 than annually thereafter, or if such designation 

19 constitutes a multiyear arrangement, in con20 junction with the renewal of the arrangement. 

21 ‘‘(B) SPECIAL QUALIFICATION IN THE

22 CASE OF CERTAIN REVIEWABLE DECISIONS.—In 

23 the case of a group health plan that provides 

24 benefits consisting of medical care to a partici25 pant or beneficiary only through health insur-
188

•S 2083 IS 

1 ance coverage offered by a single health insur2 ance issue, such issuer is the only entity that 

3 may be qualified under this paragraph to serve 

4 as a designated decisionmaker with respect to 

5 such participant or beneficiary, and shall serve 

6 as the designated decisionmaker unless the em7 ployer or other plan sponsor acts affirmatively 

8 to prevent such service. 

9 ‘‘(3) REQUIREMENTS RELATING TO FINANCIAL

10 OBLIGATIONS.—For purposes of paragraph (2)(A), 

11 the requirements relating to the financial obligation 

12 of an entity for liability shall include—

13 ‘‘(A) coverage of such entity under an in14 surance policy or other arrangement, secured 

15 and maintained by such entity, to effectively in16 sure such entity against losses arising from pro17 fessional liability claims, including those arising 

18 from its service as a designated decisionmaker 

19 under this part; or 

20 ‘‘(B) evidence of minimum capital and sur21 plus levels that are maintained by such entity 

22 to cover any losses as a result of liability arising 

23 from its service as a designated decisionmaker 

24 under this part. 
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•S 2083 IS 

1 The appropriate amounts of liability insurance and 

2 minimum capital and surplus levels for purposes of 

3 subparagraphs (A) and (B) shall be determined by 

4 an actuary using sound actuarial principles and ac5 counting practices pursuant to established guidelines 

6 of the American Academy of Actuaries and in ac7 cordance with such regulations as the Secretary may 

8 prescribe and shall be maintained throughout the 

9 term for which the designation is in effect. The pro10 visions of this paragraph shall not apply in the case 

11 of a designated decisionmaker that is a group health 

12 plan, plan sponsor, or health insurance issuer and 

13 that is regulated under Federal law or a State finan14 cial solvency law. 

15 ‘‘(4) LIMITATION ON APPOINTMENT OF TREAT16 ING PHYSICIANS.—A treating physician who directly 

17 delivered the care, treatment, or provided the patient 

18 service that is the subject of a cause of action by a 

19 participant or beneficiary under subsection (n) or 

20 section 514(d) may not be designated as a des21 ignated decisionmaker under this subsection with re22 spect to such participant or beneficiary.’’. 

23 (2) CONFORMING AMENDMENT.—Section 

24 502(a)(1) of such Act (29 U.S.C. 1132(a)(1)) is 

25 amended—
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•S 2083 IS 

1 (A) by striking ‘‘or’’ at the end of subpara2 graph (A); 

3 (B) in subparagraph (B), by striking 

4 ‘‘plan;’’ and inserting ‘‘plan, or’’; and 

5 (C) by adding at the end the following new 

6 subparagraph: 

7 ‘‘(C) for the relief provided for in sub8 section (n) of this section.’’. 

9 (b) RULES RELATING TO ERISA PREEMPTION.—

10 Section 514 of the Employee Retirement Income Security 

11 Act of 1974 (29 U.S.C. 1144) is amended—

12 (1) by redesignating subsection (d) as sub13 section (f); and 

14 (2) by inserting after subsection (c) the fol15 lowing new subsections: 

16 ‘‘(d) PREEMPTION NOT TO APPLY TO CAUSES OF

17 ACTION UNDER STATE LAW INVOLVING MEDICALLY RE18 VIEWABLE DECISION.—

19 ‘‘(1) NON-PREEMPTION OF CERTAIN CAUSES OF

20 ACTION.—

21 ‘‘(A) IN GENERAL.—Except as provided in 

22 this subsection, nothing in this title (including 

23 section 502) shall be construed to supersede or 

24 otherwise alter, amend, modify, invalidate, or 

25 impair any cause of action under State law of 
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•S 2083 IS 

1 a participant or beneficiary under a group 

2 health plan (or the estate of such a participant 

3 or beneficiary) to recover damages resulting 

4 from personal injury or for wrongful death 

5 against any person if such cause of action 

6 arises by reason of a medically reviewable deci7 sion. 

8 ‘‘(B) MEDICALLY REVIEWABLE DECI9 SION.—For purposes of subparagraph (A), the 

10 term ‘medically reviewable decision’ means a de11 nial of a claim for benefits under the plan 

12 which is described in section 104(d)(2) of the 

13 Bipartisan Patient Protection Act of 2004 (re14 lating to medically reviewable decisions). 

15 ‘‘(C) LIMITATION ON PUNITIVE DAM16 AGES.—

17 ‘‘(i) IN GENERAL.—Except as pro18 vided in clauses (ii) and (iii), with respect 

19 to a cause of action described in subpara20 graph (A) brought with respect to a partic21 ipant or beneficiary, State law is super22 seded insofar as it provides any punitive, 

23 exemplary, or similar damages if, as of the 

24 time of the personal injury or death, all 

25 the requirements of the following sections
192

•S 2083 IS 

1 of the Bipartisan Patient Protection Act of 

2 2004 were satisfied with respect to the 

3 participant or beneficiary: 

4 ‘‘(I) Section 102 (relating to pro5 cedures for initial claims for benefits 

6 and prior authorization determina7 tions). 

8 ‘‘(II) Section 103 of such Act 

9 (relating to internal appeals of claims 

10 denials). 

11 ‘‘(III) Section 104 of such Act 

12 (relating to independent external ap13 peals procedures). 

14 ‘‘(ii) EXCEPTION FOR CERTAIN AC15 TIONS FOR WRONGFUL DEATH.—Clause (i) 

16 shall not apply with respect to an action 

17 for wrongful death if the applicable State 

18 law provides (or has been construed to pro19 vide) for damages in such an action which 

20 are only punitive or exemplary in nature. 

21 ‘‘(iii) EXCEPTION FOR WILLFUL OR

22 WANTON DISREGARD FOR THE RIGHTS OR

23 SAFETY OF OTHERS.—Clause (i) shall not 

24 apply with respect to any cause of action 

25 described in subparagraph (A) if, in such 
193

•S 2083 IS 

1 action, the plaintiff establishes by clear 

2 and convincing evidence that conduct car3 ried out by the defendant with willful or 

4 wanton disregard for the rights or safety 

5 of others was a proximate cause of the per6 sonal injury or wrongful death that is the 

7 subject of the action. 

8 ‘‘(2) DEFINITIONS.—For purposes of this sub9 section and subsection (e)—

10 ‘‘(A) GROUP HEALTH PLAN AND OTHER

11 RELATED TERMS.—The provisions of sections 

12 732(d) and 733 apply for purposes of this sub13 section in the same manner as they apply for 

14 purposes of part 7, except that the term ‘group 

15 health plan’ includes a group health plan (as 

16 defined in section 607(1)). 

17 ‘‘(B) PERSONAL INJURY.—The term ‘per18 sonal injury’ means a physical injury and in19 cludes an injury arising out of the treatment 

20 (or failure to treat) a mental illness or disease. 

21 ‘‘(C) CLAIM FOR BENEFIT; DENIAL.—The 

22 terms ‘claim for benefits’ and ‘denial of a claim 

23 for benefits’ shall have the meaning provided 

24 such terms under section 102(e) of the Bipar25 tisan Patient Protection Act of 2004. 
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•S 2083 IS 

1 ‘‘(3) EXCLUSION OF EMPLOYERS AND OTHER

2 PLAN SPONSORS.—

3 ‘‘(A) CAUSES OF ACTION AGAINST EM4 PLOYERS AND PLAN SPONSORS PRECLUDED.—

5 Subject to subparagraph (B), paragraph (1) 

6 does not apply with respect to—

7 ‘‘(i) any cause of action against an 

8 employer or other plan sponsor maintain9 ing the plan (or against an employee of 

10 such an employer or sponsor acting within 

11 the scope of employment), or 

12 ‘‘(ii) a right of recovery, indemnity, or 

13 contribution by a person against an em14 ployer or other plan sponsor (or such an 

15 employee) for damages assessed against 

16 the person pursuant to a cause of action to 

17 which paragraph (1) applies. 

18 ‘‘(B) CERTAIN CAUSES OF ACTION PER19 MITTED.—Notwithstanding subparagraph (A), 

20 paragraph (1) applies with respect to any cause 

21 of action that is brought by a participant or 

22 beneficiary under a group health plan (or the 

23 estate of such a participant or beneficiary) to 

24 recover damages resulting from personal injury 

25 or for wrongful death against any employer or 
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•S 2083 IS 

1 other plan sponsor maintaining the plan (or 

2 against an employee of such an employer or 

3 sponsor acting within the scope of employment) 

4 if such cause of action arises by reason of a 

5 medically reviewable decision, to the extent that 

6 there was direct participation by the employer 

7 or other plan sponsor (or employee) in the deci8 sion. 

9 ‘‘(C) DIRECT PARTICIPATION.—

10 ‘‘(i) DIRECT PARTICIPATION IN DECI11 SIONS.—For purposes of subparagraph 

12 (B), the term ‘direct participation’ means, 

13 in connection with a decision described in 

14 subparagraph (B), the actual making of 

15 such decision or the actual exercise of con16 trol in making such decision or in the con17 duct constituting the failure. 

18 ‘‘(ii) RULES OF CONSTRUCTION.—For 

19 purposes of clause (i), the employer or plan 

20 sponsor (or employee) shall not be con21 strued to be engaged in direct participation 

22 because of any form of decisionmaking or 

23 other conduct that is merely collateral or 

24 precedent to the decision described in sub25 paragraph (B) on a particular claim for 
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•S 2083 IS 

1 benefits of a particular participant or bene2 ficiary, including (but not limited to)—

3 ‘‘(I) any participation by the em4 ployer or other plan sponsor (or em5 ployee) in the selection of the group 

6 health plan or health insurance cov7 erage involved or the third party ad8 ministrator or other agent; 

9 ‘‘(II) any engagement by the em10 ployer or other plan sponsor (or em11 ployee) in any cost-benefit analysis 

12 undertaken in connection with the se13 lection of, or continued maintenance 

14 of, the plan or coverage involved; 

15 ‘‘(III) any participation by the 

16 employer or other plan sponsor (or 

17 employee) in the process of creating, 

18 continuing, modifying, or terminating 

19 the plan or any benefit under the 

20 plan, if such process was not substan21 tially focused solely on the particular 

22 situation of the participant or bene23 ficiary referred to in paragraph 

24 (1)(A); and
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•S 2083 IS 

1 ‘‘(IV) any participation by the 

2 employer or other plan sponsor (or 

3 employee) in the design of any benefit 

4 under the plan, including the amount 

5 of copayment and limits connected 

6 with such benefit. 

7 ‘‘(iii) IRRELEVANCE OF CERTAIN COL8 LATERAL EFFORTS MADE BY EMPLOYER

9 OR PLAN SPONSOR.—For purposes of this 

10 subparagraph, an employer or plan sponsor 

11 shall not be treated as engaged in direct 

12 participation in a decision with respect to 

13 any claim for benefits or denial thereof in 

14 the case of any particular participant or 

15 beneficiary solely by reason of—

16 ‘‘(I) any efforts that may have 

17 been made by the employer or plan 

18 sponsor to advocate for authorization 

19 of coverage for that or any other par20 ticipant or beneficiary (or any group 

21 of participants or beneficiaries), or 

22 ‘‘(II) any provision that may 

23 have been made by the employer or 

24 plan sponsor for benefits which are 

25 not covered under the terms and con-
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•S 2083 IS 

1 ditions of the plan for that or any 

2 other participant or beneficiary (or 

3 any group of participants or bene4 ficiaries). 

5 ‘‘(4) REQUIREMENT OF EXHAUSTION.—

6 ‘‘(A) IN GENERAL.—Except as provided in 

7 subparagraph (D), a cause of action may not be 

8 brought under paragraph (1) in connection with 

9 any denial of a claim for benefits of any indi10 vidual until all administrative processes under 

11 sections 102, 103, and 104 of the Bipartisan 

12 Patient Protection Act of 2004 (if applicable) 

13 have been exhausted. 

14 ‘‘(B) LATE MANIFESTATION OF INJURY.—

15 ‘‘(i) IN GENERAL.—A participant or 

16 beneficiary shall not be precluded from 

17 pursuing a review under section 104 of the 

18 Bipartisan Patient Protection Act regard19 ing an injury that such participant or ben20 eficiary has experienced if the external re21 view entity first determines that the injury 

22 of such participant or beneficiary is a late 

23 manifestation of an earlier injury. 

24 ‘‘(ii) DEFINITION.—In this subpara25 graph, the term ‘late manifestation of an 
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•S 2083 IS 

1 earlier injury’ means an injury sustained 

2 by the participant or beneficiary which was 

3 not known, and should not have been 

4 known, by such participant or beneficiary 

5 by the latest date that the requirements of 

6 subparagraph (A) should have been met 

7 regarding the claim for benefits which was 

8 denied. 

9 ‘‘(C) EXCEPTION FOR NEEDED CARE.—A 

10 participant or beneficiary may seek relief exclu11 sively in Federal court under subsection 

12 502(a)(1)(B) prior to the exhaustion of admin13 istrative remedies under sections 102, 103, or 

14 104 of the Bipartisan Patient Protection Act 

15 (as required under subparagraph (A)) if it is 

16 demonstrated to the court that the exhaustion 

17 of such remedies would cause irreparable harm 

18 to the health of the participant or beneficiary. 

19 Notwithstanding the awarding of relief under 

20 subsection 502(a)(1)(B) pursuant to this sub21 paragraph, no relief shall be available as a re22 sult of, or arising under, paragraph (1)(A) un23 less the requirements of subparagraph (A) are 

24 met. 

25 ‘‘(D) FAILURE TO REVIEW.—
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•S 2083 IS 

1 ‘‘(i) IN GENERAL.—If the external re2 view entity fails to make a determination 

3 within the time required under section 

4 104(e)(1)(A)(i), a participant or bene5 ficiary may bring an action under section 

6 514(d) after 10 additional days after the 

7 date on which such time period has expired 

8 and the filing of such action shall not af9 fect the duty of the independent medical 

10 reviewer (or reviewers) to make a deter11 mination pursuant to section 

12 104(e)(1)(A)(i). 

13 ‘‘(ii) EXPEDITED DETERMINATION.—

14 If the external review entity fails to make 

15 a determination within the time required 

16 under section 104(e)(1)(A)(ii), a partici17 pant or beneficiary may bring an action 

18 under this subsection and the filing of such 

19 an action shall not affect the duty of the 

20 independent medical reviewer (or review21 ers) to make a determination pursuant to 

22 section 104(e)(1)(A)(ii). 

23 ‘‘(E) RECEIPT OF BENEFITS DURING AP24 PEALS PROCESS.—Receipt by the participant or 

25 beneficiary of the benefits involved in the claim 
201

•S 2083 IS 

1 for benefits during the pendency of any admin2 istrative processes referred to in subparagraph 

3 (A) or of any action commenced under this sub4 section—

5 ‘‘(i) shall not preclude continuation of 

6 all such administrative processes to their 

7 conclusion if so moved by any party, and 

8 ‘‘(ii) shall not preclude any liability 

9 under subsection (a)(1)(C) and this sub10 section in connection with such claim. 

11 ‘‘(F) ADMISSIBLE.—Any determination 

12 made by a reviewer in an administrative pro13 ceeding under section 104 of the Bipartisan Pa14 tient Protection Act of 2004 shall be admissible 

15 in any Federal or State court proceeding and 

16 shall be presented to the trier of fact. 

17 ‘‘(5) TOLLING PROVISION.—The statute of limi18 tations for any cause of action arising under section 

19 502(n) relating to a denial of a claim for benefits 

20 that is the subject of an action brought in State 

21 court shall be tolled until such time as the State 

22 court makes a final disposition, including all ap23 peals, of whether such claim should properly be 

24 within the jurisdiction of the State court. The tolling
202

•S 2083 IS 

1 period shall be determined by the applicable Federal 

2 or State law, whichever period is greater. 

3 ‘‘(6) EXCLUSION OF DIRECTED RECORD4 KEEPERS.—

5 ‘‘(A) IN GENERAL.—Subject to subpara6 graph (C), paragraph (1) shall not apply with 

7 respect to a directed recordkeeper in connection 

8 with a group health plan. 

9 ‘‘(B) DIRECTED RECORDKEEPER.—For 

10 purposes of this paragraph, the term ‘directed 

11 recordkeeper’ means, in connection with a 

12 group health plan, a person engaged in directed 

13 recordkeeping activities pursuant to the specific 

14 instructions of the plan or the employer or 

15 other plan sponsor, including the distribution of 

16 enrollment information and distribution of dis17 closure materials under this Act or title I of the 

18 Bipartisan Patient Protection Act of 2004 and 

19 whose duties do not include making decisions 

20 on claims for benefits. 

21 ‘‘(C) LIMITATION.—Subparagraph (A) 

22 does not apply in connection with any directed 

23 recordkeeper to the extent that the directed rec24 ordkeeper fails to follow the specific instruction 
203

•S 2083 IS 

1 of the plan or the employer or other plan spon2 sor. 

3 ‘‘(7) CONSTRUCTION.—Nothing in this sub4 section shall be construed as—

5 ‘‘(A) saving from preemption a cause of 

6 action under State law for the failure to provide 

7 a benefit for an item or service which is specifi8 cally excluded under the group health plan in9 volved, except to the extent that—

10 ‘‘(i) the application or interpretation 

11 of the exclusion involves a determination 

12 described in section 104(d)(2) of the Bi13 partisan Patient Protection Act of 2004, 

14 or 

15 ‘‘(ii) the provision of the benefit for 

16 the item or service is required under Fed17 eral law or under applicable State law con18 sistent with subsection (b)(2)(B); 

19 ‘‘(B) preempting a State law which re20 quires an affidavit or certificate of merit in a 

21 civil action; 

22 ‘‘(C) affecting a cause of action or remedy 

23 under State law in connection with the provi24 sion or arrangement of excepted benefits (as de-
204

•S 2083 IS 

1 fined in section 733(c)), other than those de2 scribed in section 733(c)(2)(A); or 

3 ‘‘(D) affecting a cause of action under 

4 State law other than a cause of action described 

5 in paragraph (1)(A). 

6 ‘‘(8) PURCHASE OF INSURANCE TO COVER LI7 ABILITY.—Nothing in section 410 shall be construed 

8 to preclude the purchase by a group health plan of 

9 insurance to cover any liability or losses arising 

10 under a cause of action described in paragraph 

11 (1)(A). 

12 ‘‘(9) RELIEF FROM LIABILITY FOR EMPLOYER

13 OR OTHER PLAN SPONSOR BY MEANS OF DES14 IGNATED DECISIONMAKER.—

15 ‘‘(A) IN GENERAL.—Paragraph (1) shall 

16 not apply with respect to any cause of action 

17 described in paragraph (1)(A) under State law 

18 insofar as such cause of action provides for li19 ability of an employer or plan sponsor (or an 

20 employee thereof acting within the scope of em21 ployment) with respect to a participant or bene22 ficiary, if with respect to the employer or plan 

23 sponsor there is deemed to be a designated de24 cisionmaker that meets the requirements of sec25 tion 502(o)(1) with respect to such participant 
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•S 2083 IS 

1 or beneficiary. Such paragraph (1) shall apply 

2 with respect to any cause of action described in 

3 paragraph (1)(A) under State law against the 

4 designated decisionmaker of such employer or 

5 other plan sponsor with respect to the partici6 pant or beneficiary. 

7 ‘‘(B) AUTOMATIC DESIGNATION.—A health 

8 insurance issuer shall be deemed to be a des9 ignated decisionmaker for purposes of subpara10 graph (A) with respect to the participants and 

11 beneficiaries of an employer or plan sponsor, 

12 whether or not the employer or plan sponsor 

13 makes such a designation, and shall be deemed 

14 to have assumed unconditionally all liability of 

15 the employer or plan sponsor under such des16 ignation in accordance with subsection (o), un17 less the employer or plan sponsor affirmatively 

18 enters into a contract to prevent the service of 

19 the designated decisionmaker. 

20 ‘‘(10) PREVIOUSLY PROVIDED SERVICES.—

21 ‘‘(A) IN GENERAL.—Except as provided in 

22 this paragraph, a cause of action shall not arise 

23 under paragraph (1) where the denial involved 

24 relates to an item or service that has already 

25 been fully provided to the participant or bene-
206

•S 2083 IS 

1 ficiary under the plan or coverage and the claim 

2 relates solely to the subsequent denial of pay3 ment for the provision of such item or service. 

4 ‘‘(B) EXCEPTION.—Nothing in subpara5 graph (A) shall be construed to—

6 ‘‘(i) prohibit a cause of action under 

7 paragraph (1) where the nonpayment in8 volved results in the participant or bene9 ficiary being unable to receive further 

10 items or services that are directly related 

11 to the item or service involved in the denial 

12 referred to in subparagraph (A) or that 

13 are part of a continuing treatment or se14 ries of procedures; 

15 ‘‘(ii) prohibit a cause of action under 

16 paragraph (1) relating to quality of care; 

17 or 

18 ‘‘(iii) limit liability that otherwise 

19 would arise from the provision of the item 

20 or services or the performance of a medical 

21 procedure. 

22 ‘‘(11) EXEMPTION FROM PERSONAL LIABILITY

23 FOR INDIVIDUAL MEMBERS OF BOARDS OF DIREC24 TORS, JOINT BOARDS OF TRUSTEES, ETC.—Any indi25 vidual who is—
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•S 2083 IS 

1 ‘‘(A) a member of a board of directors of 

2 an employer or plan sponsor; or 

3 ‘‘(B) a member of an association, com4 mittee, employee organization, joint board of 

5 trustees, or other similar group of representa6 tives of the entities that are the plan sponsor 

7 of plan maintained by two or more employers 

8 and one or more employee organizations—

9 shall not be personally liable under this subsection 

10 for conduct that is within the scope of employment 

11 of the individuals unless the individual acts in a 

12 fraudulent manner for personal enrichment. 

13 ‘‘(12) CHOICE OF LAW.—A cause of action 

14 brought under paragraph (1) shall be governed by 

15 the law (including choice of law rules) of the State 

16 in which the plaintiff resides. 

17 ‘‘(13) LIMITATION ON ATTORNEYS’ FEES.—

18 ‘‘(A) IN GENERAL.—Notwithstanding any 

19 other provision of law, or any arrangement, 

20 agreement, or contract regarding an attorney’s 

21 fee, the amount of an attorney’s contingency fee 

22 allowable for a cause of action brought under 

paragraph (1) shall not exceed 1 23 ⁄3 of the total 

24 amount of the plaintiff’s recovery (not including 
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•S 2083 IS 

1 the reimbursement of actual out-of-pocket ex2 penses of the attorney). 

3 ‘‘(B) DETERMINATION BY COURT.—The 

4 last court in which the action was pending upon 

5 the final disposition, including all appeals, of 

6 the action may review the attorney’s fee to en7 sure that the fee is a reasonable one. 

8 ‘‘(C) NO PREEMPTION OF STATE LAW.—

9 Subparagraph (A) shall not apply with respect 

10 to a cause of action under paragraph (1) that 

11 is brought in a State that has a law or frame12 work of laws with respect to the amount of an 

13 attorney’s contingency fee that may be incurred 

14 for the representation of a participant or bene15 ficiary (or the estate of such participant or ben16 eficiary) who brings such a cause of action. 

17 ‘‘(e) RULES OF CONSTRUCTION RELATING TO

18 HEALTH CARE.—Nothing in this title shall be construed 

19 as—

20 ‘‘(1) affecting any State law relating to the 

21 practice of medicine or the provision of, or the fail22 ure to provide, medical care, or affecting any action 

23 (whether the liability is direct or vicarious) based 

24 upon such a State law, 
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•S 2083 IS 

1 ‘‘(2) superseding any State law permitted under 

2 section 152(b)(1)(A) of the Bipartisan Patient Pro3 tection Act of 2004, or 

4 ‘‘(3) affecting any applicable State law with re5 spect to limitations on monetary damages.’’. 

6 (c) EFFECTIVE DATE.—The amendments made by 

7 this section shall apply to acts and omissions (from which 

8 a cause of action arises) occurring on or after the date 

9 that is 6 months after the date of enactment of this Act. 

10 SEC. 403. LIMITATION ON CERTAIN CLASS ACTION LITIGA11 TION. 

12 Section 502 of the Employee Retirement Income Se13 curity Act of 1974 (29 U.S.C. 1132), as amended by sec14 tion 402, is further amended by adding at the end the 

15 following: 

16 ‘‘(p) LIMITATION ON CLASS ACTION LITIGATION.—

17 ‘‘(1) IN GENERAL.—Any claim or cause of ac18 tion that is maintained under this section in connec19 tion with a group health plan, or health insurance 

20 coverage issued in connection with a group health 

21 plan, as a class action, derivative action, or as an ac22 tion on behalf of any group of 2 or more claimants, 

23 may be maintained only if the class, the derivative 

24 claimant, or the group of claimants is limited to the 

25 participants or beneficiaries of a group health plan 
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•S 2083 IS 

1 established by only 1 plan sponsor. No action main2 tained by such class, such derivative claimant, or 

3 such group of claimants may be joined in the same 

4 proceeding with any action maintained by another 

5 class, derivative claimant, or group of claimants or 

6 consolidated for any purpose with any other pro7 ceeding. In this paragraph, the terms ‘group health 

8 plan’ and ‘health insurance coverage’ have the mean9 ings given such terms in section 733. 

10 ‘‘(2) EFFECTIVE DATE.—This subsection shall 

11 apply to all civil actions that are filed on or after the 

12 date that is 6 months after the date of enactment 

13 of the Bipartisan Patient Protection Act of 2004.’’. 

14 SEC. 404. LIMITATIONS ON ACTIONS. 

15 Section 502 of the Employee Retirement Income Se16 curity Act of 1974 (29 U.S.C. 1132) (as amended by sec17 tion 402(a)) is amended further by adding at the end the 

18 following new subsection: 

19 ‘‘(q) LIMITATIONS ON ACTIONS RELATING TO GROUP

20 HEALTH PLANS.—

21 ‘‘(1) IN GENERAL.—Except as provided in para22 graph (2), no action may be brought under sub23 section (a)(1)(B), (a)(2), or (a)(3) by a participant 

24 or beneficiary seeking relief based on the application 

25 of any provision in section 101, subtitle B, or sub-
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•S 2083 IS 

1 title D of title I of the Bipartisan Patient Protection 

2 Act (as incorporated under section 714). 

3 ‘‘(2) CERTAIN ACTIONS ALLOWABLE.—An ac4 tion may be brought under subsection (a)(1)(B), 

5 (a)(2), or (a)(3) by a participant or beneficiary seek6 ing relief based on the application of section 101, 

7 113, 114, 115, 116, 117, 118(a)(3), 119, or 120 of 

8 the Bipartisan Patient Protection Act (as incor9 porated under section 714) to the individual cir10 cumstances of that participant or beneficiary, except 

11 that—

12 ‘‘(A) such an action may not be brought or 

13 maintained as a class action; and 

14 ‘‘(B) in such an action, relief may only 

15 provide for the provision of (or payment of) 

16 benefits, items, or services denied to the indi17 vidual participant or beneficiary involved (and 

18 for attorney’s fees and the costs of the action, 

19 at the discretion of the court) and shall not pro20 vide for any other relief to the participant or 

21 beneficiary or for any relief to any other person. 

22 ‘‘(3) OTHER PROVISIONS UNAFFECTED.—Noth23 ing in this subsection shall be construed as affecting 

24 subsections (a)(1)(C) and (n) or section 514(d).
212

•S 2083 IS 

1 ‘‘(4) ENFORCEMENT BY SECRETARY UNAF2 FECTED.—Nothing in this subsection shall be con3 strued as affecting any action brought by the Sec4 retary.’’. 

5 SEC. 405. COOPERATION BETWEEN FEDERAL AND STATE 

6 AUTHORITIES. 

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

8 Employee Retirement Income Security Act of 1974 (29 

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

10 the following new section: 

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

12 AUTHORITIES. 

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

14 enter into an agreement with the Secretary for the delega15 tion to the State of some or all of the Secretary’s authority 

16 under this title to enforce the requirements applicable 

17 under title I of the Bipartisan Patient Protection Act with 

18 respect to health insurance coverage offered by a health 

19 insurance issuer and with respect to a group health plan 

20 that is a non-Federal governmental plan. 

21 ‘‘(b) DELEGATIONS.—Any department, agency, or in22 strumentality of a State to which authority is delegated 

23 pursuant to an agreement entered into under this section 

24 may, if authorized under State law and to the extent con-
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•S 2083 IS 

1 sistent with such agreement, exercise the powers of the 

2 Secretary under this title which relate to such authority.’’. 

3 SEC. 406. SENSE OF THE SENATE CONCERNING THE IMPOR4 TANCE OF CERTAIN UNPAID SERVICES. 

5 It is the sense of the Senate that the court should 

6 consider the loss of a nonwage earning spouse or parent 

7 as an economic loss for the purposes of this section. Fur8 thermore, the court should define the compensation for the 

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

10 fully compensate for the true and whole replacement cost 

11 to the family. 

12 TITLE V—EFFECTIVE DATES; CO13 ORDINATION IN IMPLEMEN14 TATION 

15 SEC. 501. EFFECTIVE DATES. 

16 (a) GROUP HEALTH COVERAGE.—

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

18 and subsection (d), the amendments made by sec19 tions 201(a), 401, and 403 (and title I insofar as it 

20 relates to such sections) shall apply with respect to 

21 group health plans, and health insurance coverage 

22 offered in connection with group health plans, for 

23 plan years beginning on or after the date that is 6 

24 months after the date of enactment of this Act (in 
214

•S 2083 IS 

1 this section referred to as the ‘‘general effective 

2 date’’). 

3 (2) TREATMENT OF COLLECTIVE BARGAINING

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

5 maintained pursuant to one or more collective bar6 gaining agreements between employee representa7 tives and one or more employers ratified before the 

8 date of the enactment of this Act, the amendments 

9 made by sections 201(a), 401, and 403 (and title I 

10 insofar as it relates to such sections) shall not apply 

11 to plan years beginning before the later of—

12 (A) the date on which the last collective 

13 bargaining agreements relating to the plan ter14 minates (excluding any extension thereof agreed 

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

16 or 

17 (B) the general effective date—

18 but shall apply not later than 1 year after the gen19 eral effective date. For purposes of subparagraph 

20 (A), any plan amendment made pursuant to a collec21 tive bargaining agreement relating to the plan which 

22 amends the plan solely to conform to any require23 ment added by this Act shall not be treated as a ter24 mination of such collective bargaining agreement. 
215

•S 2083 IS 

1 (b) INDIVIDUAL HEALTH INSURANCE COVERAGE.—

2 Subject to subsection (d), the amendments made by sec3 tion 202 shall apply with respect to individual health in4 surance coverage offered, sold, issued, renewed, in effect, 

5 or operated in the individual market on or after the gen6 eral effective date. 

7 (c) TREATMENT OF RELIGIOUS NONMEDICAL PRO8 VIDERS.—

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

10 amendments made thereby) shall be construed to—

11 (A) restrict or limit the right of group 

12 health plans, and of health insurance issuers of13 fering health insurance coverage, to include as 

14 providers religious nonmedical providers; 

15 (B) require such plans or issuers to—

16 (i) utilize medically based eligibility 

17 standards or criteria in deciding provider 

18 status of religious nonmedical providers; 

19 (ii) use medical professionals or cri20 teria to decide patient access to religious 

21 nonmedical providers; 

22 (iii) utilize medical professionals or 

23 criteria in making decisions in internal or 

24 external appeals regarding coverage for 

25 care by religious nonmedical providers; or 
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1 (iv) compel a participant or bene2 ficiary to undergo a medical examination 

3 or test as a condition of receiving health 

4 insurance coverage for treatment by a reli5 gious nonmedical provider; or 

6 (C) require such plans or issuers to ex7 clude religious nonmedical providers because 

8 they do not provide medical or other required 

9 data, if such data is inconsistent with the reli10 gious nonmedical treatment or nursing care 

11 provided by the provider. 

12 (2) RELIGIOUS NONMEDICAL PROVIDER.—For 

13 purposes of this subsection, the term ‘‘religious non14 medical provider’’ means a provider who provides no 

15 medical care but who provides only religious non16 medical treatment or religious nonmedical nursing 

17 care. 

18 (d) TRANSITION FOR NOTICE REQUIREMENT.—The 

19 disclosure of information required under section 121 of 

20 this Act shall first be provided pursuant to—

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

22 health plan that is maintained as of the general ef23 fective date, not later than 30 days before the begin24 ning of the first plan year to which title I applies
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1 in connection with the plan under such subsection; 

2 or 

3 (2) subsection (b) with respect to a individual 

4 health insurance coverage that is in effect as of the 

5 general effective date, not later than 30 days before 

6 the first date as of which title I applies to the cov7 erage under such subsection. 

8 SEC. 502. COORDINATION IN IMPLEMENTATION. 

9 The Secretary of Labor and the Secretary of Health 

10 and Human Services shall ensure, through the execution 

11 of an interagency memorandum of understanding among 

12 such Secretaries, that—

13 (1) regulations, rulings, and interpretations 

14 issued by such Secretaries relating to the same mat15 ter over which such Secretaries have responsibility 

16 under the provisions of this Act (and the amend17 ments made thereby) are administered so as to have 

18 the same effect at all times; and 

19 (2) coordination of policies relating to enforcing 

20 the same requirements through such Secretaries in 

21 order to have a coordinated enforcement strategy 

22 that avoids duplication of enforcement efforts and 

23 assigns priorities in enforcement. 
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1 SEC. 503. SEVERABILITY. 

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

3 this Act, or the application of such provision or amend4 ment to any person or circumstance is held to be unconsti5 tutional, the remainder of this Act, the amendments made 

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

7 to any person or circumstance shall not be affected there8 by. 

9 TITLE VI—MISCELLANEOUS 

10 PROVISIONS 

11 SEC. 601. NO IMPACT ON SOCIAL SECURITY TRUST FUND. 

12 (a) IN GENERAL.—Nothing in this Act (or an amend13 ment made by this Act) shall be construed to alter or 

14 amend the Social Security Act (or any regulation promul15 gated under that Act). 

16 (b) TRANSFERS.—

17 (1) ESTIMATE OF SECRETARY.—The Secretary 

18 of the Treasury shall annually estimate the impact 

19 that the enactment of this Act has on the income 

20 and balances of the trust funds established under 

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

22 401). 

23 (2) TRANSFER OF FUNDS.—If, under para24 graph (1), the Secretary of the Treasury estimates 

25 that the enactment of this Act has a negative impact 

26 on the income and balances of the trust funds estab-
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1 lished under section 201 of the Social Security Act 

2 (42 U.S.C. 401), the Secretary shall transfer, not 

3 less frequently than quarterly, from the general reve4 nues of the Federal Government an amount suffi5 cient so as to ensure that the income and balances 

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

7 the enactment of such Act. 

8 SEC. 602. CUSTOMS USER FEES. 

9 Section 13031(j)(3) of the Consolidated Omnibus 

10 Budget Reconciliation Act of 1985 (19 U.S.C. 58c(j)(3)) 

11 is amended by striking ‘‘March 31, 2004’’ and inserting 

12 ‘‘December 31, 2014’’. 

13 SEC. 603. FISCAL YEAR 2005 MEDICARE PAYMENTS. 

14 Notwithstanding any other provision of law, any let15 ter of credit under part B of title XVIII of the Social Se16 curity Act (42 U.S.C. 1395j et seq.) that would otherwise 

17 be sent to the Treasury or the Federal Reserve Board on 

18 September 30, 2005, by a carrier with a contract under 

19 section 1842 of that Act (42 U.S.C. 1395u) shall be sent 

20 on October 1, 2005. 

21 SEC. 604. SENSE OF SENATE WITH RESPECT TO PARTICIPA22 TION IN CLINICAL TRIALS AND ACCESS TO 

23 SPECIALTY CARE. 

24 (a) FINDINGS.—The Senate 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 2004, 215,900 new cases of female 

4 invasive breast cancer will be diagnosed, and 40,110 

5 women will die from the disease. 

6 (3) In addition, 1,450 male breast cancer cases 

7 are projected to be diagnosed, and 470 men will die 

8 from the disease. 

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

10 cancer death among all women. 

11 (5) This year 9,200 children are expected to be 

12 diagnosed with cancer. 

13 (6) 1,510 children are expected to die from can14 cer this year. 

15 (7) There are approximately 400,000 people di16 agnosed with multiple sclerosis in the United States 

17 and 200 more cases are diagnosed each week. 

18 (8) Parkinson’s disease is a progressive disorder 

19 of the central nervous system affecting 1,500,000 in 

20 the United States. 

21 (9) An estimated 230,110 men will be diag22 nosed with prostate cancer this year. 

23 (10) 29,500 men will die from prostate cancer 

24 this year. It is the leading cause of cancer in men 

25 and the second leading cause of death. 
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1 (11) While information obtained from clinical 

2 trials is essential to finding cures for diseases, it is 

3 still research which carries the risk of fatal results. 

4 Future efforts should be taken to protect the health 

5 and safety of adults and children who enroll in clin6 ical trials. 

7 (12) While employers and health plans should 

8 be responsible for covering the routine costs associ9 ated with federally approved or funded clinical trials, 

10 such employers and health plans should not be held 

11 legally responsible for the design, implementation, or 

12 outcome of such clinical trials, consistent with any 

13 applicable State or Federal liability statutes. 

14 (b) SENSE OF THE SENATE.—It is the sense of the 

15 Senate that— 

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

17 deadly diseases, including advanced breast or ovar18 ian cancer, should have the opportunity to partici19 pate in a federally approved or funded clinical trial 

20 recommended by their physician; 

21 (2) an individual should have the opportunity to 

22 participate in a federally approved or funded clinical 

23 trial recommended by their physician if—

24 (A) that individual—
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1 (i) has a life-threatening or serious ill2 ness for which no standard treatment is ef3 fective; 

4 (ii) is eligible to participate in a feder5 ally approved or funded clinical trial ac6 cording to the trial protocol with respect to 

7 treatment of the illness; 

8 (B) that individual’s participation in the 

9 trial offers meaningful potential for significant 

10 clinical benefit for the individual; and 

11 (C) either—

12 (i) the referring physician is a partici13 pating health care professional and has 

14 concluded that the individual’s participa15 tion in the trial would be appropriate, 

16 based upon the individual meeting the con17 ditions described in subparagraph (A); or 

18 (ii) the participant, beneficiary, or en19 rollee provides medical and scientific infor20 mation establishing that the individual’s 

21 participation in the trial would be appro22 priate, based upon the individual meeting 

23 the conditions described in subparagraph 

24 (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. 605. SENSE OF THE SENATE REGARDING FAIR REVIEW 

17 PROCESS. 

18 (a) FINDINGS.—The Senate 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 SENATE.—It is the sense of the 

13 Senate 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. 606. ANNUAL REVIEW. 

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

9 the general effective date referred to in section 501(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) LIMITATION WITH RESPECT TO CERTAIN

20 PLANS.—If the Secretary, in any report submitted under 

21 subsection (a), determines that more than 1,000,000 indi22 viduals in the United States have lost their health insur23 ance coverage as a result of the enactment of this Act, 

24 as compared to the number of individuals with health in25 surance coverage in the 12-month period preceding the 
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1 date of enactment of this Act, section 402 of this Act shall 

2 be repealed effective on the date that is 12 month after 

3 the date on which the report is submitted, and the submis4 sion of any further reports under subsection (a) shall not 

5 be required. 

6 (c) FUNDING.—From funds appropriated to the De7 partment of Health and Human Services for fiscal years 

8 2005 and 2006, the Secretary of Health and Human Serv9 ices shall provide for such funding as the Secretary deter10 mines necessary for the conduct of the study of the Na11 tional Academy of Sciences under this section.

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