II

107TH CONGRESS

1ST SESSION S. 1052

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

JUNE 14, 2001

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

following bill; which was read the first time

A BILL

To amend the Public Health Service Act and the Employee

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

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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

5 ‘‘Bipartisan Patient Protection Act’’.

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

7 this Act is as follows:

Sec. 1. Short title; table of contents.

TITLE I—IMPROVING MANAGED CARE

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.

Subtitle B—Access to Care

Sec. 111. Consumer choice option.

Sec. 112. Choice of health care professional.

Sec. 113. Access to emergency care.

Sec. 114. Timely access to specialists.

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

Sec. 116. Access to pediatric care.

Sec. 117. Continuity of care.

Sec. 118. Access to needed prescription drugs.

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

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

lymph node dissections for the treatment of breast cancer and

coverage for secondary consultations.

Subtitle C—Access to Information

Sec. 121. Patient access to information.

Subtitle D—Protecting the Doctor-Patient Relationship

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

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

Sec. 133. Prohibition against improper incentive arrangements.

Sec. 134. Payment of claims.

Sec. 135. Protection for patient advocacy.

Subtitle E—Definitions

Sec. 151. Definitions.

Sec. 152. Preemption; State flexibility; construction.

Sec. 153. Exclusions.

Sec. 154. Coverage of limited scope plans.

Sec. 155. Regulations.

Sec. 156. Incorporation into plan or coverage documents.

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.

TITLE III—AMENDMENTS TO THE EMPLOYEE RETIREMENT

INCOME SECURITY ACT OF 1974

Sec. 301. Application of patient protection standards to group health plans and

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

Sec. 302. Availability of civil remedies.

Sec. 303. Limitations on actions.
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TITLE IV—EFFECTIVE DATES; COORDINATION IN

IMPLEMENTATION

Sec. 401. Effective dates.

Sec. 402. Coordination in implementation.

Sec. 403. Severability.

TITLE V—MISCELLANEOUS PROVISIONS

Sec. 501. No impact on Social Security Trust Fund.

Sec. 502. Customs user fees.

Sec. 503. Fiscal year 2002 medicare payments.

1 TITLE I—IMPROVING MANAGED

2 CARE

3 Subtitle A—Utilization Review;

4 Claims; and Internal and Exter5 nal Appeals

6 SEC. 101. UTILIZATION REVIEW ACTIVITIES.

7 (a) COMPLIANCE WITH REQUIREMENTS.—

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

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

12 under such plan or coverage only in accordance with

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

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

16 section shall be construed as preventing a group

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

19 entities to conduct utilization review activities on be20 half of the plan or issuer, so long as such activities
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1 are conducted in accordance with a utilization review

2 program that meets the requirements of this section.

3 (3) UTILIZATION REVIEW DEFINED.—For pur4 poses of this section, the terms ‘‘utilization review’’

5 and ‘‘utilization review activities’’ mean procedures

6 used to monitor or evaluate the use or coverage,

7 clinical necessity, appropriateness, efficacy, or effi8 ciency of health care services, procedures or settings,

9 and includes prospective review, concurrent review,

10 second opinions, case management, discharge plan11 ning, or retrospective review.

12 (b) WRITTEN POLICIES AND CRITERIA.—

13 (1) WRITTEN POLICIES.—A utilization review

14 program shall be conducted consistent with written

15 policies and procedures that govern all aspects of the

16 program.

17 (2) USE OF WRITTEN CRITERIA.—

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

19 utilize written clinical review criteria developed

20 with input from a range of appropriate actively

21 practicing health care professionals, as deter22 mined by the plan, pursuant to the program.

23 Such criteria shall include written clinical re24 view criteria that are based on valid clinical evi25 dence where available and that are directed spe-
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1 cifically at meeting the needs of at-risk popu2 lations and covered individuals with chronic

3 conditions or severe illnesses, including gender4 specific criteria and pediatric-specific criteria

5 where available and appropriate.

6 (B) CONTINUING USE OF STANDARDS IN

7 RETROSPECTIVE REVIEW.—If a health care

8 service has been specifically pre-authorized or

9 approved for a participant, beneficiary, or en10 rollee under such a program, the program shall

11 not, pursuant to retrospective review, revise or

12 modify the specific standards, criteria, or proce13 dures used for the utilization review for proce14 dures, treatment, and services delivered to the

15 enrollee during the same course of treatment.

16 (C) REVIEW OF SAMPLE OF CLAIMS DENI17 ALS.—Such a program shall provide for a peri18 odic evaluation of the clinical appropriateness of

19 at least a sample of denials of claims for bene20 fits.

21 (c) CONDUCT OF PROGRAM ACTIVITIES.—

22 (1) ADMINISTRATION BY HEALTH CARE PRO23 FESSIONALS.—A utilization review program shall be

24 administered by qualified health care professionals

25 who shall oversee review decisions.
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1 (2) USE OF QUALIFIED, INDEPENDENT PER2 SONNEL.—

3 (A) IN GENERAL.—A utilization review

4 program shall provide for the conduct of utiliza5 tion review activities only through personnel

6 who are qualified and have received appropriate

7 training in the conduct of such activities under

8 the program.

9 (B) PROHIBITION OF CONTINGENT COM10 PENSATION ARRANGEMENTS.—Such a program

11 shall not, with respect to utilization review ac12 tivities, permit or provide compensation or any13 thing of value to its employees, agents, or con14 tractors in a manner that encourages denials of

15 claims for benefits.

16 (C) PROHIBITION OF CONFLICTS.—Such a

17 program shall not permit a health care profes18 sional who is providing health care services to

19 an individual to perform utilization review ac20 tivities in connection with the health care serv21 ices being provided to the individual.

22 (3) ACCESSIBILITY OF REVIEW.—Such a pro23 gram shall provide that appropriate personnel per24 forming utilization review activities under the pro25 gram, including the utilization review administrator,
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1 are reasonably accessible by toll-free telephone dur2 ing normal business hours to discuss patient care

3 and allow response to telephone requests, and that

4 appropriate provision is made to receive and respond

5 promptly to calls received during other hours.

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

7 shall not provide for the performance of utilization

8 review activities with respect to a class of services

9 furnished to an individual more frequently than is

10 reasonably required to assess whether the services

11 under review are medically necessary and appro12 priate.

13 SEC. 102. PROCEDURES FOR INITIAL CLAIMS FOR BENE14 FITS AND PRIOR AUTHORIZATION DETER15 MINATIONS.

16 (a) PROCEDURES OF INITIAL CLAIMS FOR BENE17 FITS.—

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

19 health insurance issuer offering health insurance

20 coverage, shall—

21 (A) make a determination on an initial

22 claim for benefits by a participant, beneficiary,

23 or enrollee (or authorized representative) re24 garding payment or coverage for items or serv25 ices under the terms and conditions of the plan
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1 or coverage involved, including any cost-sharing

2 amount that the participant, beneficiary, or en3 rollee is required to pay with respect to such

4 claim for benefits; and

5 (B) notify a participant, beneficiary, or en6 rollee (or authorized representative) and the

7 treating health care professional involved re8 garding a determination on an initial claim for

9 benefits made under the terms and conditions

10 of the plan or coverage, including any cost-shar11 ing amounts that the participant, beneficiary,

12 or enrollee may be required to make with re13 spect to such claim for benefits, and of the

14 right of the participant, beneficiary, or enrollee

15 to an internal appeal under section 103.

16 (2) ACCESS TO INFORMATION.—

17 (A) TIMELY PROVISION OF NECESSARY IN18 FORMATION.—With respect to an initial claim

19 for benefits, the participant, beneficiary, or en20 rollee (or authorized representative) and the

21 treating health care professional (if any) shall

22 provide the plan or issuer with access to infor23 mation requested by the plan or issuer that is

24 necessary to make a determination relating to

25 the claim. Such access shall be provided not
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1 later than 5 days after the date on which the

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

3 described in subparagraph (B) or (C) of sub4 section (b)(1), by such earlier time as may be

5 necessary to comply with the applicable timeline

6 under such subparagraph.

7 (B) LIMITED EFFECT OF FAILURE ON

8 PLAN OR ISSUER’S OBLIGATIONS.—Failure of

9 the participant, beneficiary, or enrollee to com10 ply with the requirements of subparagraph (A)

11 shall not remove the obligation of the plan or

12 issuer to make a decision in accordance with

13 the medical exigencies of the case and as soon

14 as possible, based on the available information,

15 and failure to comply with the time limit estab16 lished by this paragraph shall not remove the

17 obligation of the plan or issuer to comply with

18 the requirements of this section.

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

20 for benefits involving an expedited or concurrent de21 termination, a participant, beneficiary, or enrollee

22 (or authorized representative) may make an initial

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

24 health insurance issuer offering health insurance

25 coverage, may require that the participant, bene-
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1 ficiary, or enrollee (or authorized representative)

2 provide written confirmation of such request in a

3 timely manner on a form provided by the plan or

4 issuer. In the case of such an oral request for bene5 fits, the making of the request (and the timing of

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

7 time of a claims for such benefits without regard to

8 whether and when a written confirmation of such re9 quest is made.

10 (b) TIMELINE FOR MAKING DETERMINATIONS.—

11 (1) PRIOR AUTHORIZATION DETERMINATION.—

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

13 health insurance issuer offering health insur14 ance coverage, shall make a prior authorization

15 determination on a claim for benefits (whether

16 oral or written) in accordance with the medical

17 exigencies of the case and as soon as possible,

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

19 on which the plan or issuer receives information

20 that is reasonably necessary to enable the plan

21 or issuer to make a determination on the re22 quest for prior authorization and in no case

23 later than 28 days after the date of the claim

24 for benefits is received.
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1 (B) EXPEDITED DETERMINATION.—Not2 withstanding subparagraph (A), a group health

3 plan, or health insurance issuer offering health

4 insurance coverage, shall expedite a prior au5 thorization determination on a claim for bene6 fits described in such subparagraph when a re7 quest for such an expedited determination is

8 made by a participant, beneficiary, or enrollee

9 (or authorized representative) at any time dur10 ing the process for making a determination and

11 a health care professional certifies, with the re12 quest, that a determination under the proce13 dures described in subparagraph (A) would seri14 ously jeopardize the life or health of the partici15 pant, beneficiary, or enrollee or the ability of

16 the participant, beneficiary, or enrollee to main17 tain or regain maximum function. Such deter18 mination shall be made in accordance with the

19 medical exigencies of the case and as soon as

20 possible, but in no case later than 72 hours

21 after the time the request is received by the

22 plan or issuer under this subparagraph.

23 (C) ONGOING CARE.—

24 (i) CONCURRENT REVIEW.—
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1 (I) IN GENERAL.—Subject to

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

3 review of ongoing care (including hos4 pitalization), which results in a termi5 nation or reduction of such care, the

6 plan or issuer must provide by tele7 phone and in printed form notice of

8 the concurrent review determination

9 to the individual or the individual’s

10 designee and the individual’s health

11 care provider in accordance with the

12 medical exigencies of the case and as

13 soon as possible, with sufficient time

14 prior to the termination or reduction

15 to allow for an appeal under section

16 103(b)(3) to be completed before the

17 termination or reduction takes effect.

18 (II) CONTENTS OF NOTICE.—

19 Such notice shall include, with respect

20 to ongoing health care items and serv21 ices, the number of ongoing services

22 approved, the new total of approved

23 services, the date of onset of services,

24 and the next review date, if any, as
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1 well as a statement of the individual’s

2 rights to further appeal.

3 (ii) RULE OF CONSTRUCTION.—Clause

4 (i) shall not be construed as requiring

5 plans or issuers to provide coverage of care

6 that would exceed the coverage limitations

7 for such care.

8 (2) RETROSPECTIVE DETERMINATION.—A

9 group health plan, or health insurance issuer offer10 ing health insurance coverage, shall make a retro11 spective determination on a claim for benefits in ac12 cordance with the medical exigencies of the case and

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

14 the date on which the plan or issuer receives infor15 mation that is reasonably necessary to enable the

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

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

18 claim for benefits.

19 (c) NOTICE OF A DENIAL OF A CLAIM FOR BENE20 FITS.—Written notice of a denial made under an initial

21 claim for benefits shall be issued to the participant, bene22 ficiary, or enrollee (or authorized representative) and the

23 treating health care professional in accordance with the

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

25 in no case later than 2 days after the date of the deter-
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1 mination (or, in the case described in subparagraph (B)

2 or (C) of subsection (b)(1), within the 72-hour or applica3 ble period referred to in such subparagraph).

4 (d) REQUIREMENTS OF NOTICE OF DETERMINA5 TIONS.—The written notice of a denial of a claim for bene6 fits determination under subsection (c) shall be provided

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

8 understood by the participant, beneficiary, or enrollee and

9 shall include—

10 (1) the specific reasons for the determination

11 (including a summary of the clinical or scientific evi12 dence used in making the determination);

13 (2) the procedures for obtaining additional in14 formation concerning the determination; and

15 (3) notification of the right to appeal the deter16 mination and instructions on how to initiate an ap17 peal in accordance with section 103.

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

19 (1) AUTHORIZED REPRESENTATIVE.—The term

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

21 an individual who is a participant, beneficiary, or en22 rollee, any health care professional or other person

23 acting on behalf of the individual with the individ24 ual’s consent or without such consent if the indi25 vidual is medically unable to provide such consent.
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1 (2) CLAIM FOR BENEFITS.—The term ‘‘claim

2 for benefits’’ means any request for coverage (in3 cluding authorization of coverage), for eligibility, or

4 for payment in whole or in part, for an item or serv5 ice under a group health plan or health insurance

6 coverage.

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

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

9 benefits, a denial (in whole or in part) of, or a fail10 ure to act on a timely basis upon, the claim for ben11 efits and includes a failure to provide benefits (in12 cluding items and services) required to be provided

13 under this title.

14 (4) TREATING HEALTH CARE PROFESSIONAL.—

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

16 with respect to services to be provided to a partici17 pant, beneficiary, or enrollee, a health care profes18 sional who is primarily responsible for delivering

19 those services to the participant, beneficiary, or en20 rollee.

21 SEC. 103. INTERNAL APPEALS OF CLAIMS DENIALS.

22 (a) RIGHT TO INTERNAL APPEAL.—

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

24 enrollee (or authorized representative) may appeal
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1 any denial of a claim for benefits under section 102

2 under the procedures described in this section.

3 (2) TIME FOR APPEAL.—

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

5 health insurance issuer offering health insur6 ance coverage, shall ensure that a participant,

7 beneficiary, or enrollee (or authorized represent8 ative) has a period of not less than 180 days

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

10 benefits under section 102 in which to appeal

11 such denial under this section.

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

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

14 be deemed to be the date as of which the partic15 ipant, beneficiary, or enrollee knew of the denial

16 of the claim for benefits.

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

18 issuer to issue a determination on a claim for bene19 fits under section 102 within the applicable timeline

20 established for such a determination under such sec21 tion is a denial of a claim for benefits for purposes

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

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

24 group health plan, or health insurance issuer offer25 ing health insurance coverage, may waive the inter-
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1 nal review process under this section. In such case

2 the plan or issuer shall provide notice to the partici3 pant, beneficiary, or enrollee (or authorized rep4 resentative) involved, the participant, beneficiary, or

5 enrollee (or authorized representative) involved shall

6 be relieved of any obligation to complete the internal

7 review involved, and may, at the option of such par8 ticipant, beneficiary, enrollee, or representative pro9 ceed directly to seek further appeal through external

10 review under section 104 or otherwise.

11 (b) TIMELINES FOR MAKING DETERMINATIONS.—

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

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

14 that involves an expedited or concurrent determina15 tion, a participant, beneficiary, or enrollee (or au16 thorized representative) may request such appeal

17 orally. A group health plan, or health insurance

18 issuer offering health insurance coverage, may re19 quire that the participant, beneficiary, or enrollee

20 (or authorized representative) provide written con21 firmation of such request in a timely manner on a

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

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

24 making of the request (and the timing of such re25 quest) shall be treated as the making at that time
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1 of a request for an appeal without regard to whether

2 and when a written confirmation of such request is

3 made.

4 (2) ACCESS TO INFORMATION.—

5 (A) TIMELY PROVISION OF NECESSARY IN6 FORMATION.—With respect to an appeal of a

7 denial of a claim for benefits, the participant,

8 beneficiary, or enrollee (or authorized represent9 ative) and the treating health care professional

10 (if any) shall provide the plan or issuer with ac11 cess to information requested by the plan or

12 issuer that is necessary to make a determina13 tion relating to the appeal. Such access shall be

14 provided not later than 5 days after the date on

15 which the request for information is received,

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

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

18 may be necessary to comply with the applicable

19 timeline under such subparagraph.

20 (B) LIMITED EFFECT OF FAILURE ON

21 PLAN OR ISSUER’S OBLIGATIONS.—Failure of

22 the participant, beneficiary, or enrollee to com23 ply with the requirements of subparagraph (A)

24 shall not remove the obligation of the plan or

25 issuer to make a decision in accordance with
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1 the medical exigencies of the case and as soon

2 as possible, based on the available information,

3 and failure to comply with the time limit estab4 lished by this paragraph shall not remove the

5 obligation of the plan or issuer to comply with

6 the requirements of this section.

7 (3) PRIOR AUTHORIZATION DETERMINA8 TIONS.—

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

10 health insurance issuer offering health insur11 ance coverage, shall make a determination on

12 an appeal of a denial of a claim for benefits

13 under this subsection in accordance with the

14 medical exigencies of the case and as soon as

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

16 the date on which the plan or issuer receives in17 formation that is reasonably necessary to enable

18 the plan or issuer to make a determination on

19 the appeal and in no case later than 28 days

20 after the date the request for the appeal is re21 ceived.

22 (B) EXPEDITED DETERMINATION.—Not23 withstanding subparagraph (A), a group health

24 plan, or health insurance issuer offering health

25 insurance coverage, shall expedite a prior au-
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1 thorization determination on an appeal of a de2 nial of a claim for benefits described in sub3 paragraph (A), when a request for such an ex4 pedited determination is made by a participant,

5 beneficiary, or enrollee (or authorized represent6 ative) at any time during the process for mak7 ing a determination and a health care profes8 sional certifies, with the request, that a deter9 mination under the procedures described in sub10 paragraph (A) would seriously jeopardize the

11 life or health of the participant, beneficiary, or

12 enrollee or the ability of the participant, bene13 ficiary, or enrollee to maintain or regain max14 imum function. Such determination shall be

15 made in accordance with the medical exigencies

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

17 case later than 72 hours after the time the re18 quest for such appeal is received by the plan or

19 issuer under this subparagraph.

20 (C) ONGOING CARE DETERMINATIONS.—

21 (i) IN GENERAL.—Subject to clause

22 (ii), in the case of a concurrent review de23 termination described in section

24 102(b)(1)(C)(i)(I), which results in a ter25 mination or reduction of such care, the
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1 plan or issuer must provide notice of the

2 determination on the appeal under this

3 section by telephone and in printed form to

4 the individual or the individual’s designee

5 and the individual’s health care provider in

6 accordance with the medical exigencies of

7 the case and as soon as possible, with suf8 ficient time prior to the termination or re9 duction to allow for an external appeal

10 under section 104 to be completed before

11 the termination or reduction takes effect.

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 (4) RETROSPECTIVE DETERMINATION.—A

18 group health plan, or health insurance issuer offer19 ing health insurance coverage, shall make a retro20 spective determination on an appeal of a claim for

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

22 on which the plan or issuer receives necessary infor23 mation that is reasonably necessary to enable the

24 plan or issuer to make a determination on the ap-
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1 peal and in no case later than 60 days after the

2 date the request for the appeal is received.

3 (c) CONDUCT OF REVIEW.—

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

5 claim for benefits under this section shall be con6 ducted by an individual with appropriate expertise

7 who was not involved in the initial determination.

8 (2) REVIEW OF MEDICAL DECISIONS BY PHYSI9 CIANS.—A review of an appeal of a denial of a claim

10 for benefits that is based on a lack of medical neces11 sity and appropriateness, or based on an experi12 mental or investigational treatment, or requires an

13 evaluation of medical facts, shall be made by a phy14 sician (allopathic or osteopathic) with appropriate

15 expertise (including, in the case of a child, appro16 priate pediatric expertise) who was not involved in

17 the initial determination.

18 (d) NOTICE OF DETERMINATION.—

19 (1) IN GENERAL.—Written notice of a deter20 mination made under an internal appeal of a denial

21 of a claim for benefits shall be issued to the partici22 pant, beneficiary, or enrollee (or authorized rep23 resentative) and the treating health care professional

24 in accordance with the medical exigencies of the case

25 and as soon as possible, but in no case later than
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1 2 days after the date of completion of the review (or,

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

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

4 period referred to in such subparagraph).

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

6 plan or issuer under this section shall be treated as

7 the final determination of the plan or issuer on a de8 nial of a claim for benefits. The failure of a plan or

9 issuer to issue a determination on an appeal of a de10 nial of a claim for benefits under this section within

11 the applicable timeline established for such a deter12 mination shall be treated as a final determination on

13 an appeal of a denial of a claim for benefits for pur14 poses of proceeding to external review under section

15 104.

16 (3) REQUIREMENTS OF NOTICE.—With respect

17 to a determination made under this section, the no18 tice described in paragraph (1) shall be provided in

19 printed form and written in a manner calculated to

20 be understood by the participant, beneficiary, or en21 rollee and shall include—

22 (A) the specific reasons for the determina23 tion (including a summary of the clinical or sci24 entific evidence used in making the determina25 tion);
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1 (B) the procedures for obtaining additional

2 information concerning the determination; and

3 (C) notification of the right to an inde4 pendent external review under section 104 and

5 instructions on how to initiate such a review.

6 SEC. 104. INDEPENDENT EXTERNAL APPEALS PROCE7 DURES.

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

9 plan, and a health insurance issuer offering health insur10 ance coverage, shall provide in accordance with this sec11 tion participants, beneficiaries, and enrollees (or author12 ized representatives) with access to an independent exter13 nal review for any denial of a claim for benefits.

14 (b) INITIATION OF THE INDEPENDENT EXTERNAL

15 REVIEW PROCESS.—

16 (1) TIME TO FILE.—A request for an inde17 pendent external review under this section shall be

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

19 after the date on which the participant, beneficiary,

20 or enrollee receives notice of the denial under section

21 103(d) or notice of waiver of internal review under

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

23 issuer has failed to make a timely decision under

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

25 beneficiary that it has failed to make a timely deci-
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1 sion and that the beneficiary must file an appeal

2 with an external review entity within 180 days if the

3 participant or beneficiary desires to file such an ap4 peal.

5 (2) FILING OF REQUEST.—

6 (A) IN GENERAL.—Subject to the suc7 ceeding provisions of this subsection, a group

8 health plan, and a health insurance issuer offer9 ing health insurance coverage, may—

10 (i) except as provided in subparagraph

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

12 in writing;

13 (ii) limit the filing of such a request

14 to the participant, beneficiary, or enrollee

15 involved (or an authorized representative);

16 (iii) except if waived by the plan or

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

18 access to an independent external review

19 under this section upon a final determina20 tion of a denial of a claim for benefits

21 under the internal review procedure under

22 section 103;

23 (iv) except as provided in subpara24 graph (B)(ii), require payment of a filing
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1 fee to the plan or issuer of a sum that does

2 not exceed $25; and

3 (v) require that a request for review

4 include the consent of the participant, ben5 eficiary, or enrollee (or authorized rep6 resentative) for the release of necessary

7 medical information or records of the par8 ticipant, beneficiary, or enrollee to the

9 qualified external review entity only for

10 purposes of conducting external review ac11 tivities.

12 (B) REQUIREMENTS AND EXCEPTION RE13 LATING TO GENERAL RULE.—

14 (i) ORAL REQUESTS PERMITTED IN

15 EXPEDITED OR CONCURRENT CASES.—In

16 the case of an expedited or concurrent ex17 ternal review as provided for under sub18 section (e), the request may be made oral19 ly. A group health plan, or health insur20 ance issuer offering health insurance cov21 erage, may require that the participant,

22 beneficiary, or enrollee (or authorized rep23 resentative) provide written confirmation

24 of such request in a timely manner on a

25 form provided by the plan or issuer. Such
27

•S 1052 IS

1 written confirmation shall be treated as a

2 consent for purposes of subparagraph

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

4 for such a review, the making of the re5 quest (and the timing of such request)

6 shall be treated as the making at that time

7 of a request for such an external review

8 without regard to whether and when a

9 written confirmation of such request is

10 made.

11 (ii) EXCEPTION TO FILING FEE RE12 QUIREMENT.—

13 (I) INDIGENCY.—Payment of a

14 filing fee shall not be required under

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

16 certification (in a form and manner

17 specified in guidelines established by

18 the appropriate Secretary) that the

19 participant, beneficiary, or enrollee is

20 indigent (as defined in such guide21 lines).

22 (II) FEE NOT REQUIRED.—Pay23 ment of a filing fee shall not be re24 quired under subparagraph (A)(iv) if

25 the plan or issuer waives the internal
28

•S 1052 IS

1 appeals process under section

2 103(a)(4).

3 (III) REFUNDING OF FEE.—The

4 filing fee paid under subparagraph

5 (A)(iv) shall be refunded if the deter6 mination under the independent exter7 nal review is to reverse or modify the

8 denial which is the subject of the re9 view.

10 (IV) COLLECTION OF FILING

11 FEE.—The failure to pay such a filing

12 fee shall not prevent the consideration

13 of a request for review but, subject to

14 the preceding provisions of this clause,

15 shall constitute a legal liability to pay.

16 (c) REFERRAL TO QUALIFIED EXTERNAL REVIEW

17 ENTITY UPON REQUEST.—

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

19 for independent external review with the group

20 health plan, or health insurance issuer offering

21 health insurance coverage, the plan or issuer shall

22 immediately refer such request, and forward the

23 plan or issuer’s initial decision (including the infor24 mation described in section 103(d)(3)(A)), to a
29

•S 1052 IS

1 qualified external review entity selected in accord2 ance with this section.

3 (2) ACCESS TO PLAN OR ISSUER AND HEALTH

4 PROFESSIONAL INFORMATION.—With respect to an

5 independent external review conducted under this

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

7 authorized representative), the plan or issuer, and

8 the treating health care professional (if any) shall

9 provide the external review entity with information

10 that is necessary to conduct a review under this sec11 tion, as determined and requested by the entity.

12 Such information shall be provided not later than 5

13 days after the date on which the request for infor14 mation is received, or, in a case described in clause

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

16 time as may be necessary to comply with the appli17 cable timeline under such clause.

18 (3) SCREENING OF REQUESTS BY QUALIFIED

19 EXTERNAL REVIEW ENTITIES.—

20 (A) IN GENERAL.—With respect to a re21 quest referred to a qualified external review en22 tity under paragraph (1) relating to a denial of

23 a claim for benefits, the entity shall refer such

24 request for the conduct of an independent med25 ical review unless the entity determines that—
30

•S 1052 IS

1 (i) any of the conditions described in

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

3 have not been met;

4 (ii) the denial of the claim for benefits

5 does not involve a medically reviewable de6 cision under subsection (d)(2);

7 (iii) the denial of the claim for bene8 fits relates to a decision regarding whether

9 an individual is a participant, beneficiary,

10 or enrollee who is enrolled under the terms

11 and conditions of the plan or coverage (in12 cluding the applicability of any waiting pe13 riod under the plan or coverage); or

14 (iv) the denial of the claim for bene15 fits is a decision as to the application of

16 cost-sharing requirements or the applica17 tion of a specific exclusion or express limi18 tation on the amount, duration, or scope of

19 coverage of items or services under the

20 terms and conditions of the plan or cov21 erage unless the decision is a denial de22 scribed in subsection (d)(2).

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

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

25 shall determine that the denial of a claim for benefits in-
31

•S 1052 IS

1 volved is not eligible for independent medical review under

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

3 subparagraph (C).

4 (B) PROCESS FOR MAKING DETERMINA5 TIONS.—

6 (i) NO DEFERENCE TO PRIOR DETER7 MINATIONS.—In making determinations

8 under subparagraph (A), there shall be no

9 deference given to determinations made by

10 the plan or issuer or the recommendation

11 of a treating health care professional (if

12 any).

13 (ii) USE OF APPROPRIATE PER14 SONNEL.—A qualified external review enti15 ty shall use appropriately qualified per16 sonnel to make determinations under this

17 section.

18 (C) NOTICES AND GENERAL TIMELINES

19 FOR DETERMINATION.—

20 (i) NOTICE IN CASE OF DENIAL OF

21 REFERRAL.—If the entity under this para22 graph does not make a referral to an inde23 pendent medical reviewer, the entity shall

24 provide notice to the plan or issuer, the

25 participant, beneficiary, or enrollee (or au-
32

•S 1052 IS

1 thorized representative) filing the request,

2 and the treating health care professional

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

4 independent medical review. Such notice—

5 (I) shall be written (and, in addi6 tion, may be provided orally) in a

7 manner calculated to be understood

8 by a participant or enrollee;

9 (II) shall include the reasons for

10 the determination;

11 (III) include any relevant terms

12 and conditions of the plan or cov13 erage; and

14 (IV) include a description of any

15 further recourse available to the indi16 vidual.

17 (ii) GENERAL TIMELINE FOR DETER18 MINATIONS.—Upon receipt of information

19 under paragraph (2), the qualified external

20 review entity, and if required the inde21 pendent medical reviewer, shall make a de22 termination within the overall timeline that

23 is applicable to the case under review as

24 described in subsection (e), except that if

25 the entity determines that a referral to an
33

•S 1052 IS

1 independent medical reviewer is not re2 quired, the entity shall provide notice of

3 such determination to the participant, ben4 eficiary, or enrollee (or authorized rep5 resentative) within such timeline and with6 in 2 days of the date of such determina7 tion.

8 (d) INDEPENDENT MEDICAL REVIEW.—

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

10 entity determines under subsection (c) that a denial

11 of a claim for benefits is eligible for independent

12 medical review, the entity shall refer the denial in13 volved to an independent medical reviewer for the

14 conduct of an independent medical review under this

15 subsection.

16 (2) MEDICALLY REVIEWABLE DECISIONS.—A

17 denial of a claim for benefits is eligible for inde18 pendent medical review if the benefit for the item or

19 service for which the claim is made would be a cov20 ered benefit under the terms and conditions of the

21 plan or coverage but for one (or more) of the fol22 lowing determinations:

23 (A) DENIALS BASED ON MEDICAL NECES24 SITY AND APPROPRIATENESS.—A determination

25 that the item or service is not covered because
34

•S 1052 IS

1 it is not medically necessary and appropriate or

2 based on the application of substantially equiva3 lent terms.

4 (B) DENIALS BASED ON EXPERIMENTAL

5 OR INVESTIGATIONAL TREATMENT.—A deter6 mination that the item or service is not covered

7 because it is experimental or investigational or

8 based on the application of substantially equiva9 lent terms.

10 (C) DENIALS OTHERWISE BASED ON AN

11 EVALUATION OF MEDICAL FACTS.—A deter12 mination that the item or service or condition

13 is not covered based on grounds that require an

14 evaluation of the medical facts by a health care

15 professional in the specific case involved to de16 termine the coverage and extent of coverage of

17 the item or service or condition.

18 (3) INDEPENDENT MEDICAL REVIEW DETER19 MINATION.—

20 (A) IN GENERAL.—An independent med21 ical reviewer under this section shall make a

22 new independent determination with respect to

23 whether or not the denial of a claim for a ben24 efit that is the subject of the review should be

25 upheld, reversed, or modified.
35

•S 1052 IS

1 (B) STANDARD FOR DETERMINATION.—

2 The independent medical reviewer’s determina3 tion relating to the medical necessity and ap4 propriateness, or the experimental or investiga5 tion nature, or the evaluation of the medical

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

7 based on the medical condition of the partici8 pant, beneficiary, or enrollee (including the

9 medical records of the participant, beneficiary,

10 or enrollee) and valid, relevant scientific evi11 dence and clinical evidence, including peer-re12 viewed medical literature or findings and in13 cluding expert opinion.

14 (C) NO COVERAGE FOR EXCLUDED BENE15 FITS.—Nothing in this subsection shall be con16 strued to permit an independent medical re17 viewer to require that a group health plan, or

18 health insurance issuer offering health insur19 ance coverage, provide coverage for items or

20 services for which benefits are specifically ex21 cluded or expressly limited under the plan or

22 coverage in the plain language of the plan docu23 ment (and which are disclosed under section

24 121(b)(1)(C)) except to the extent that the ap25 plication or interpretation of the exclusion or
36

•S 1052 IS

1 limitation involves a determination described in

2 paragraph (2).

3 (D) EVIDENCE AND INFORMATION TO BE

4 USED IN MEDICAL REVIEWS.—In making a de5 termination under this subsection, the inde6 pendent medical reviewer shall also consider ap7 propriate and available evidence and informa8 tion, including the following:

9 (i) The determination made by the

10 plan or issuer with respect to the claim

11 upon internal review and the evidence,

12 guidelines, or rationale used by the plan or

13 issuer in reaching such determination.

14 (ii) The recommendation of the treat15 ing health care professional and the evi16 dence, guidelines, and rationale used by

17 the treating health care professional in

18 reaching such recommendation.

19 (iii) Additional relevant evidence or

20 information obtained by the reviewer or

21 submitted by the plan, issuer, participant,

22 beneficiary, or enrollee (or an authorized

23 representative), or treating health care

24 professional.

25 (iv) The plan or coverage document.
37

•S 1052 IS

1 (E) INDEPENDENT DETERMINATION.—In

2 making determinations under this subtitle, a

3 qualified external review entity and an inde4 pendent medical reviewer shall—

5 (i) consider the claim under review

6 without deference to the determinations

7 made by the plan or issuer or the rec8 ommendation of the treating health care

9 professional (if any); and

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

11 definition used by the plan or issuer of

12 ‘‘medically necessary and appropriate’’, or

13 ‘‘experimental or investigational’’, or other

14 substantially equivalent terms that are

15 used by the plan or issuer to describe med16 ical necessity and appropriateness or ex17 perimental or investigational nature of the

18 treatment.

19 (F) DETERMINATION OF INDEPENDENT

20 MEDICAL REVIEWER.—An independent medical

21 reviewer shall, in accordance with the deadlines

22 described in subsection (e), prepare a written

23 determination to uphold, reverse, or modify the

24 denial under review. Such written determination

25 shall include—
38

•S 1052 IS

1 (i) the determination of the reviewer;

2 (ii) the specific reasons of the re3 viewer for such determination, including a

4 summary of the clinical or scientific evi5 dence used in making the determination;

6 and

7 (iii) with respect to a determination to

8 reverse or modify the denial under review,

9 a timeframe within which the plan or

10 issuer must comply with such determina11 tion.

12 (G) NONBINDING NATURE OF ADDITIONAL

13 RECOMMENDATIONS.—In addition to the deter14 mination under subparagraph (F), the reviewer

15 may provide the plan or issuer and the treating

16 health care professional with additional rec17 ommendations in connection with such a deter18 mination, but any such recommendations shall

19 not affect (or be treated as part of) the deter20 mination and shall not be binding on the plan

21 or issuer.

22 (e) TIMELINES AND NOTIFICATIONS.—

23 (1) TIMELINES FOR INDEPENDENT MEDICAL

24 REVIEW.—
39

•S 1052 IS

1 (A) PRIOR AUTHORIZATION DETERMINA2 TION.—

3 (i) IN GENERAL.—The independent

4 medical reviewer (or reviewers) shall make

5 a determination on a denial of a claim for

6 benefits that is referred to the reviewer

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

8 the medical exigencies of the case and as

9 soon as possible, but in no case later than

10 14 days after the date of receipt of infor11 mation under subsection (c)(2) if the re12 view involves a prior authorization of items

13 or services and in no case later than 21

14 days after the date the request for external

15 review is received.

16 (ii) EXPEDITED DETERMINATION.—

17 Notwithstanding clause (i) and subject to

18 clause (iii), the independent medical re19 viewer (or reviewers) shall make an expe20 dited determination on a denial of a claim

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

22 request for such an expedited determina23 tion is made by a participant, beneficiary,

24 or enrollee (or authorized representative)

25 at any time during the process for making
40

•S 1052 IS

1 a determination, and a health care profes2 sional certifies, with the request, that a de3 termination under the timeline described in

4 clause (i) would seriously jeopardize the

5 life or health of the participant, bene6 ficiary, or enrollee or the ability of the par7 ticipant, beneficiary, or enrollee to main8 tain or regain maximum function. Such de9 termination shall be made as soon in ac10 cordance with the medical exigencies of the

11 case and as soon as possible, but in no

12 case later than 72 hours after the time the

13 request for external review is received by

14 the qualified external review entity.

15 (iii) ONGOING CARE DETERMINA16 TION.—Notwithstanding clause (i), in the

17 case of a review described in such sub18 clause that involves a termination or reduc19 tion of care, the notice of the determina20 tion shall be completed not later than 24

21 hours after the time the request for exter22 nal review is received by the qualified ex23 ternal review entity and before the end of

24 the approved period of care.
41

•S 1052 IS

1 (B) RETROSPECTIVE DETERMINATION.—

2 The independent medical reviewer (or review3 ers) shall complete a review in the case of a ret4 rospective determination on an appeal of a de5 nial of a claim for benefits that is referred to

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

7 later than 30 days after the date of receipt of

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

9 case later than 60 days after the date the re10 quest for external review is received by the

11 qualified external review entity.

12 (2) NOTIFICATION OF DETERMINATION.—The

13 external review entity shall ensure that the plan or

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

15 authorized representative) and the treating health

16 care professional (if any) receives a copy of the writ17 ten determination of the independent medical re18 viewer prepared under subsection (d)(3)(F). Nothing

19 in this paragraph shall be construed as preventing

20 an entity or reviewer from providing an initial oral

21 notice of the reviewer’s determination.

22 (3) FORM OF NOTICES.—Determinations and

23 notices under this subsection shall be written in a

24 manner calculated to be understood by a participant.

25 (f) COMPLIANCE.—
42

•S 1052 IS

1 (1) APPLICATION OF DETERMINATIONS.—

2 (A) EXTERNAL REVIEW DETERMINATIONS

3 BINDING ON PLAN.—The determinations of an

4 external review entity and an independent med5 ical reviewer under this section shall be binding

6 upon the plan or issuer involved.

7 (B) COMPLIANCE WITH DETERMINA8 TION.—If the determination of an independent

9 medical reviewer is to reverse or modify the de10 nial, the plan or issuer, upon the receipt of such

11 determination, shall authorize coverage to com12 ply with the medical reviewer’s determination in

13 accordance with the timeframe established by

14 the medical reviewer.

15 (2) FAILURE TO COMPLY.—

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

17 to comply with the timeframe established under

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

19 beneficiary, or enrollee, where such failure to

20 comply is caused by the plan or issuer, the par21 ticipant, beneficiary, or enrollee may obtain the

22 items or services involved (in a manner con23 sistent with the determination of the inde24 pendent external reviewer) from any provider
43

•S 1052 IS

1 regardless of whether such provider is a partici2 pating provider under the plan or coverage.

3 (B) REIMBURSEMENT.—

4 (i) IN GENERAL.—Where a partici5 pant, beneficiary, or enrollee obtains items

6 or services in accordance with subpara7 graph (A), the plan or issuer involved shall

8 provide for reimbursement of the costs of

9 such items or services. Such reimburse10 ment shall be made to the treating health

11 care professional or to the participant, ben12 eficiary, or enrollee (in the case of a partic13 ipant, beneficiary, or enrollee who pays for

14 the costs of such items or services).

15 (ii) AMOUNT.—The plan or issuer

16 shall fully reimburse a professional, partici17 pant, beneficiary, or enrollee under clause

18 (i) for the total costs of the items or serv19 ices provided (regardless of any plan limi20 tations that may apply to the coverage of

21 such items or services) so long as the items

22 or services were provided in a manner con23 sistent with the determination of the inde24 pendent medical reviewer.
44

•S 1052 IS

1 (C) FAILURE TO REIMBURSE.—Where a

2 plan or issuer fails to provide reimbursement to

3 a professional, participant, beneficiary, or en4 rollee in accordance with this paragraph, the

5 professional, participant, beneficiary, or enrollee

6 may commence a civil action (or utilize other

7 remedies available under law) to recover only

8 the amount of any such reimbursement that is

9 owed by the plan or issuer and any necessary

10 legal costs or expenses (including attorney’s

11 fees) incurred in recovering such reimburse12 ment.

13 (D) AVAILABLE REMEDIES.—The remedies

14 provided under this paragraph are in addition

15 to any other available remedies.

16 (3) PENALTIES AGAINST AUTHORIZED OFFI17 CIALS FOR REFUSING TO AUTHORIZE THE DETER18 MINATION OF AN EXTERNAL REVIEW ENTITY.—

19 (A) MONETARY PENALTIES.—

20 (i) IN GENERAL.—In any case in

21 which the determination of an external re22 view entity is not followed by a group

23 health plan, or by a health insurance issuer

24 offering health insurance coverage, any

25 person who, acting in the capacity of au-
45

•S 1052 IS

1 thorizing the benefit, causes such refusal

2 may, in the discretion in a court of com3 petent jurisdiction, be liable to an ag4 grieved participant, beneficiary, or enrollee

5 for a civil penalty in an amount of up to

6 $1,000 a day from the date on which the

7 determination was transmitted to the plan

8 or issuer by the external review entity until

9 the date the refusal to provide the benefit

10 is corrected.

11 (ii) ADDITIONAL PENALTY FOR FAIL12 ING TO FOLLOW TIMELINE.—In any case

13 in which treatment was not commenced by

14 the plan in accordance with the determina15 tion of an independent external reviewer,

16 the Secretary shall assess a civil penalty of

17 $10,000 against the plan and the plan

18 shall pay such penalty to the participant,

19 beneficiary, or enrollee involved.

20 (B) CEASE AND DESIST ORDER AND

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

22 described in subparagraph (A) brought by a

23 participant, beneficiary, or enrollee with respect

24 to a group health plan, or a health insurance

25 issuer offering health insurance coverage, in
46

•S 1052 IS

1 which a plaintiff alleges that a person referred

2 to in such subparagraph has taken an action re3 sulting in a refusal of a benefit determined by

4 an external appeal entity to be covered, or has

5 failed to take an action for which such person

6 is responsible under the terms and conditions of

7 the plan or coverage and which is necessary

8 under the plan or coverage for authorizing a

9 benefit, the court shall cause to be served on

10 the defendant an order requiring the

11 defendant—

12 (i) to cease and desist from the al13 leged action or failure to act; and

14 (ii) to pay to the plaintiff a reasonable

15 attorney’s fee and other reasonable costs

16 relating to the prosecution of the action on

17 the charges on which the plaintiff prevails.

18 (C) ADDITIONAL CIVIL PENALTIES.—

19 (i) IN GENERAL.—In addition to any

20 penalty imposed under subparagraph (A)

21 or (B), the appropriate Secretary may as22 sess a civil penalty against a person acting

23 in the capacity of authorizing a benefit de24 termined by an external review entity for

25 one or more group health plans, or health
47

•S 1052 IS

1 insurance issuers offering health insurance

2 coverage, for—

3 (I) any pattern or practice of re4 peated refusal to authorize a benefit

5 determined by an external appeal enti6 ty to be covered; or

7 (II) any pattern or practice of re8 peated violations of the requirements

9 of this section with respect to such

10 plan or coverage.

11 (ii) STANDARD OF PROOF AND

12 AMOUNT OF PENALTY.—Such penalty shall

13 be payable only upon proof by clear and

14 convincing evidence of such pattern or

15 practice and shall be in an amount not to

16 exceed the lesser of—

17 (I) 25 percent of the aggregate

18 value of benefits shown by the appro19 priate Secretary to have not been pro20 vided, or unlawfully delayed, in viola21 tion of this section under such pattern

22 or practice; or

23 (II) $500,000.

24 (D) REMOVAL AND DISQUALIFICATION.—

25 Any person acting in the capacity of author-
48

•S 1052 IS

1 izing benefits who has engaged in any such pat2 tern or practice described in subparagraph

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

4 the petition of the appropriate Secretary, may

5 be removed by the court from such position,

6 and from any other involvement, with respect to

7 such a plan or coverage, and may be precluded

8 from returning to any such position or involve9 ment for a period determined by the court.

10 (4) PROTECTION OF LEGAL RIGHTS.—Nothing

11 in this subsection or subtitle shall be construed as

12 altering or eliminating any cause of action or legal

13 rights or remedies of participants, beneficiaries, en14 rollees, and others under State or Federal law (in15 cluding sections 502 and 503 of the Employee Re16 tirement Income Security Act of 1974), including

17 the right to file judicial actions to enforce rights.

18 (g) QUALIFICATIONS OF INDEPENDENT MEDICAL

19 REVIEWERS.—

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

21 more individuals to conduct independent medical re22 view under subsection (c), the qualified external re23 view entity shall ensure that—
49

•S 1052 IS

1 (A) each independent medical reviewer

2 meets the qualifications described in paragraphs

3 (2) and (3);

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

5 such reviewer meets the requirements described

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

7 (C) compensation provided by the entity to

8 the reviewer is consistent with paragraph (6).

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

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

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

15 care services; and

16 (B) typically treats the condition, makes

17 the diagnosis, or provides the type of treatment

18 under review.

19 (3) INDEPENDENCE.—

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

22 in a case shall—

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

24 in paragraph (7));
50

•S 1052 IS

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

3 such a party; and

4 (iii) not otherwise have a conflict of

5 interest with such a party (as determined

6 under regulations).

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

9 (i) prohibit an individual, solely on the

10 basis of affiliation with the plan or issuer,

11 from serving as an independent medical re12 viewer if—

13 (I) a non-affiliated individual is

14 not reasonably available;

15 (II) the affiliated individual is

16 not involved in the provision of items

17 or services in the case under review;

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

20 and the participant, beneficiary, or

21 enrollee (or authorized representative)

22 and neither party objects; and

23 (IV) the affiliated individual is

24 not an employee of the plan or issuer

25 and does not provide services exclu-
51

•S 1052 IS

1 sively or primarily to or on behalf of

2 the plan or issuer;

3 (ii) prohibit an individual who has

4 staff privileges at the institution where the

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

7 merely on the basis of such affiliation if

8 the affiliation is disclosed to the plan or

9 issuer and the participant, beneficiary, or

10 enrollee (or authorized representative), and

11 neither party objects; or

12 (iii) prohibit receipt of compensation

13 by an independent medical reviewer from

14 an entity if the compensation is provided

15 consistent with paragraph (6).

16 (4) PRACTICING HEALTH CARE PROFESSIONAL

17 IN SAME FIELD.—

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

19 treatment, or the provision of items or

20 services—

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

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

24 a physician who typically treats the condi-
52

•S 1052 IS

1 tion, makes the diagnosis, or provides the

2 type of treatment under review; or

3 (ii) by a health care professional

4 (other than a physician), a reviewer shall

5 be a practicing physician (allopathic or os6 teopathic) or, if determined appropriate by

7 the qualified external review entity, a prac8 ticing health care professional (other than

9 such a physician), of the same or similar

10 specialty as the health care professional

11 who typically treats the condition, makes

12 the diagnosis, or provides the type of treat13 ment under review.

14 (B) PRACTICING DEFINED.—For purposes

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

16 with respect to an individual who is a physician

17 or other health care professional that the indi18 vidual provides health care services to individual

19 patients on average at least 2 days per week.

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

21 external review relating to a child, a reviewer shall

22 have expertise under paragraph (2) in pediatrics.

23 (6) LIMITATIONS ON REVIEWER COMPENSA24 TION.—Compensation provided by a qualified exter25 nal review entity to an independent medical reviewer
53

•S 1052 IS

1 in connection with a review under this section

2 shall—

3 (A) not exceed a reasonable level; and

4 (B) not be contingent on the decision ren5 dered by the reviewer.

6 (7) RELATED PARTY DEFINED.—For purposes

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

8 respect to a denial of a claim under a plan or cov9 erage relating to a participant, beneficiary, or en10 rollee, any of the following:

11 (A) The plan, plan sponsor, or issuer in12 volved, or any fiduciary, officer, director, or em13 ployee of such plan, plan sponsor, or issuer.

14 (B) The participant, beneficiary, or en15 rollee (or authorized representative).

16 (C) The health care professional that pro17 vides the items or services involved in the de18 nial.

19 (D) The institution at which the items or

20 services (or treatment) involved in the denial

21 are provided.

22 (E) The manufacturer of any drug or

23 other item that is included in the items or serv24 ices involved in the denial.
54

•S 1052 IS

1 (F) Any other party determined under any

2 regulations to have a substantial interest in the

3 denial involved.

4 (h) QUALIFIED EXTERNAL REVIEW ENTITIES.—

5 (1) SELECTION OF QUALIFIED EXTERNAL RE6 VIEW ENTITIES.—

7 (A) LIMITATION ON PLAN OR ISSUER SE8 LECTION.—The appropriate Secretary shall im9 plement procedures—

10 (i) to assure that the selection process

11 among qualified external review entities

12 will not create any incentives for external

13 review entities to make a decision in a bi14 ased manner; and

15 (ii) for auditing a sample of decisions

16 by such entities to assure that no such de17 cisions are made in a biased manner.

18 No such selection process under the procedures

19 implemented by the appropriate Secretary may

20 give either the patient or the plan or issuer any

21 ability to determine or influence the selection of

22 a qualified external review entity to review the

23 case of any participant, beneficiary, or enrollee.

24 (B) STATE AUTHORITY WITH RESPECT TO

25 QUALIFIED EXTERNAL REVIEW ENTITIES FOR
55

•S 1052 IS

1 HEALTH INSURANCE ISSUERS.—With respect to

2 health insurance issuers offering health insur3 ance coverage in a State, the State may provide

4 for external review activities to be conducted by

5 a qualified external appeal entity that is des6 ignated by the State or that is selected by the

7 State in a manner determined by the State to

8 assure an unbiased determination.

9 (2) CONTRACT WITH QUALIFIED EXTERNAL RE10 VIEW ENTITY.—Except as provided in paragraph

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

12 issuer under this section shall be conducted under a

13 contract between the plan or issuer and 1 or more

14 qualified external review entities (as defined in para15 graph (4)(A)).

16 (3) TERMS AND CONDITIONS OF CONTRACT.—

17 The terms and conditions of a contract under para18 graph (2) shall—

19 (A) be consistent with the standards the

20 appropriate Secretary shall establish to assure

21 there is no real or apparent conflict of interest

22 in the conduct of external review activities; and

23 (B) provide that the costs of the external

24 review process shall be borne by the plan or

25 issuer.
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•S 1052 IS

1 Subparagraph (B) shall not be construed as apply2 ing to the imposition of a filing fee under subsection

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

4 beneficiary, or enrollee (or authorized representative)

5 or treating health care professional (if any) in sup6 port of the review, including the provision of addi7 tional evidence or information.

8 (4) QUALIFICATIONS.—

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

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

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

12 initially certified (and periodically recertified)

13 under subparagraph (C) as meeting the fol14 lowing requirements:

15 (i) The entity has (directly or through

16 contracts or other arrangements) sufficient

17 medical, legal, and other expertise and suf18 ficient staffing to carry out duties of a

19 qualified external review entity under this

20 section on a timely basis, including making

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

22 and providing for independent medical re23 views under subsection (d).

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

25 or an affiliate or a subsidiary of a plan or
57

•S 1052 IS

1 issuer, and is not an affiliate or subsidiary

2 of a professional or trade association of

3 plans or issuers or of health care providers.

4 (iii) The entity has provided assur5 ances that it will conduct external review

6 activities consistent with the applicable re7 quirements of this section and standards

8 specified in subparagraph (C), including

9 that it will not conduct any external review

10 activities in a case unless the independence

11 requirements of subparagraph (B) are met

12 with respect to the case.

13 (iv) The entity has provided assur14 ances that it will provide information in a

15 timely manner under subparagraph (D).

16 (v) The entity meets such other re17 quirements as the appropriate Secretary

18 provides by regulation.

19 (B) INDEPENDENCE REQUIREMENTS.—

20 (i) IN GENERAL.—Subject to clause

21 (ii), an entity meets the independence re22 quirements of this subparagraph with re23 spect to any case if the entity—

24 (I) is not a related party (as de25 fined in subsection (g)(7));
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•S 1052 IS

1 (II) does not have a material fa2 milial, financial, or professional rela3 tionship with such a party; and

4 (III) does not otherwise have a

5 conflict of interest with such a party

6 (as determined under regulations).

7 (ii) EXCEPTION FOR REASONABLE

8 COMPENSATION.—Nothing in clause (i)

9 shall be construed to prohibit receipt by a

10 qualified external review entity of com11 pensation from a plan or issuer for the

12 conduct of external review activities under

13 this section if the compensation is provided

14 consistent with clause (iii).

15 (iii) LIMITATIONS ON ENTITY COM16 PENSATION.—Compensation provided by a

17 plan or issuer to a qualified external review

18 entity in connection with reviews under

19 this section shall—

20 (I) not exceed a reasonable level;

21 and

22 (II) not be contingent on any de23 cision rendered by the entity or by

24 any independent medical reviewer.
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•S 1052 IS

1 (C) CERTIFICATION AND RECERTIFICATION

2 PROCESS.—

3 (i) IN GENERAL.—The initial certifi4 cation and recertification of a qualified ex5 ternal review entity shall be made—

6 (I) under a process that is recog7 nized or approved by the appropriate

8 Secretary; or

9 (II) by a qualified private stand10 ard-setting organization that is ap11 proved by the appropriate Secretary

12 under clause (iii).

13 In taking action under subclause (I), the

14 appropriate Secretary shall give deference

15 to entities that are under contract with the

16 Federal Government or with an applicable

17 State authority to perform functions of the

18 type performed by qualified external review

19 entities.

20 (ii) PROCESS.—The appropriate Sec21 retary shall not recognize or approve a

22 process under clause (i)(I) unless the proc23 ess applies standards (as promulgated in

24 regulations) that ensure that a qualified

25 external review entity—
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•S 1052 IS

1 (I) will carry out (and has car2 ried out, in the case of recertification)

3 the responsibilities of such an entity

4 in accordance with this section, in5 cluding meeting applicable deadlines;

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

7 the case of recertification) appropriate

8 indicators of fiscal integrity;

9 (III) will maintain (and has

10 maintained, in the case of recertifi11 cation) appropriate confidentiality

12 with respect to individually identifi13 able health information obtained in

14 the course of conducting external re15 view activities; and

16 (IV) in the case recertification,

17 shall review the matters described in

18 clause (iv).

19 (iii) APPROVAL OF QUALIFIED PRI20 VATE STANDARD-SETTING ORGANIZA21 TIONS.—For purposes of clause (i)(II), the

22 appropriate Secretary may approve a quali23 fied private standard-setting organization

24 if such Secretary finds that the organiza25 tion only certifies (or recertifies) external
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•S 1052 IS

1 review entities that meet at least the

2 standards required for the certification (or

3 recertification) of external review entities

4 under clause (ii).

5 (iv) CONSIDERATIONS IN RECERTIFI6 CATIONS.—In conducting recertifications of

7 a qualified external review entity under

8 this paragraph, the appropriate Secretary

9 or organization conducting the recertifi10 cation shall review compliance of the entity

11 with the requirements for conducting ex12 ternal review activities under this section,

13 including the following:

14 (I) Provision of information

15 under subparagraph (D).

16 (II) Adherence to applicable

17 deadlines (both by the entity and by

18 independent medical reviewers it re19 fers cases to).

20 (III) Compliance with limitations

21 on compensation (with respect to both

22 the entity and independent medical re23 viewers it refers cases to).

24 (IV) Compliance with applicable

25 independence requirements.
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•S 1052 IS

1 (v) PERIOD OF CERTIFICATION OR RE2 CERTIFICATION.—A certification or recer3 tification provided under this paragraph

4 shall extend for a period not to exceed 2

5 years.

6 (vi) REVOCATION.—A certification or

7 recertification under this paragraph may

8 be revoked by the appropriate Secretary or

9 by the organization providing such certifi10 cation upon a showing of cause.

11 (vii) SUFFICIENT NUMBER OF ENTI12 TIES.—The appropriate Secretary shall

13 certify and recertify a number of external

14 review entities which is sufficient to ensure

15 the timely and efficient provision of review

16 services.

17 (D) PROVISION OF INFORMATION.—

18 (i) IN GENERAL.—A qualified external

19 review entity shall provide to the appro20 priate Secretary, in such manner and at

21 such times as such Secretary may require,

22 such information (relating to the denials

23 which have been referred to the entity for

24 the conduct of external review under this

25 section) as such Secretary determines ap-
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•S 1052 IS

1 propriate to assure compliance with the

2 independence and other requirements of

3 this section to monitor and assess the qual4 ity of its external review activities and lack

5 of bias in making determinations. Such in6 formation shall include information de7 scribed in clause (ii) but shall not include

8 individually identifiable medical informa9 tion.

10 (ii) INFORMATION TO BE IN11 CLUDED.—The information described in

12 this subclause with respect to an entity is

13 as follows:

14 (I) The number and types of de15 nials for which a request for review

16 has been received by the entity.

17 (II) The disposition by the entity

18 of such denials, including the number

19 referred to a independent medical re20 viewer and the reasons for such dis21 positions (including the application of

22 exclusions), on a plan or issuer-spe23 cific basis and on a health care spe24 cialty-specific basis.
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•S 1052 IS

1 (III) The length of time in mak2 ing determinations with respect to

3 such denials.

4 (IV) Updated information on the

5 information required to be submitted

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

8 external review activities.

9 (iii) INFORMATION TO BE PROVIDED

10 TO CERTIFYING ORGANIZATION.—

11 (I) IN GENERAL.—In the case of

12 a qualified external review entity

13 which is certified (or recertified)

14 under this subsection by a qualified

15 private standard-setting organization,

16 at the request of the organization, the

17 entity shall provide the organization

18 with the information provided to the

19 appropriate Secretary under clause

20 (i).

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

23 shall be construed as preventing such

24 an organization from requiring addi25 tional information as a condition of
65

•S 1052 IS

1 certification or recertification of an

2 entity.

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

5 be used by the appropriate Secretary and

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

10 available to the public in an appropriate

11 manner.

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

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

17 independent medical reviewer), shall be held by

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

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

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

23 malice or gross misconduct in the performance

24 of such duty, function, or activity.
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1 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 1052 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
68

•S 1052 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-
69

•S 1052 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

12 enrollee—

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
70

•S 1052 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
71

•S 1052 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 1052 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
73

•S 1052 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 1052 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-
75

•S 1052 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 1052 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 1052 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 OBSTETRIC 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 1052 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 1052 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 1052 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 1052 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 1052 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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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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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 1052 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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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 1052 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 1052 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 1052 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 1052 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 1052 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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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;

7 (iii) either of the following if the con8 ditions described in paragraph (2) are

9 met—

10 (I) the Department of Veterans

11 Affairs;

12 (II) the Department of Defense;

13 or

14 (B) approved by the Food and Drug Ad15 ministration.

16 (2) CONDITIONS FOR DEPARTMENTS.—The

17 conditions described in this paragraph, for a study

18 or investigation conducted by a Department, are

19 that the study or investigation has been reviewed

20 and approved through a system of peer review that

21 the appropriate Secretary determines—

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

23 review of studies and investigations used by the

24 National Institutes of Health; and
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•S 1052 IS

1 (B) assures unbiased review of the highest

2 scientific standards by qualified individuals who

3 have no interest in the outcome of the review.

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

5 construed to limit a plan’s or issuer’s coverage with re6 spect to clinical trials.

7 SEC. 120. REQUIRED COVERAGE FOR MINIMUM HOSPITAL

8 STAY FOR MASTECTOMIES AND LYMPH NODE

9 DISSECTIONS FOR THE TREATMENT OF

10 BREAST CANCER AND COVERAGE FOR SEC11 ONDARY CONSULTATIONS.

12 (a) INPATIENT CARE.—

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

14 health insurance issuer providing health insurance

15 coverage, that provides medical and surgical benefits

16 shall ensure that inpatient coverage with respect to

17 the treatment of breast cancer is provided for a pe18 riod of time as is determined by the attending physi19 cian, in consultation with the patient, to be medi20 cally necessary and appropriate following—

21 (A) a mastectomy;

22 (B) a lumpectomy; or

23 (C) a lymph node dissection for the treat24 ment of breast cancer.
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•S 1052 IS

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

2 be construed as requiring the provision of inpatient

3 coverage if the attending physician and patient de4 termine that a shorter period of hospital stay is

5 medically appropriate.

6 (b) PROHIBITION ON CERTAIN MODIFICATIONS.—In

7 implementing the requirements of this section, a group

8 health plan, and a health insurance issuer providing health

9 insurance coverage, may not modify the terms and condi10 tions of coverage based on the determination by a partici11 pant, beneficiary, or enrollee to request less than the min12 imum coverage required under subsection (a).

13 (c) SECONDARY CONSULTATIONS.—

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

15 health insurance issuer providing health insurance

16 coverage, that provides coverage with respect to

17 medical and surgical services provided in relation to

18 the diagnosis and treatment of cancer shall ensure

19 that full coverage is provided for secondary consulta20 tions by specialists in the appropriate medical fields

21 (including pathology, radiology, and oncology) to

22 confirm or refute such diagnosis. Such plan or issuer

23 shall ensure that full coverage is provided for such

24 secondary consultation whether such consultation is

25 based on a positive or negative initial diagnosis. In
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•S 1052 IS

1 any case in which the attending physician certifies in

2 writing that services necessary for such a secondary

3 consultation are not sufficiently available from spe4 cialists operating under the plan or coverage with re5 spect to whose services coverage is otherwise pro6 vided under such plan or by such issuer, such plan

7 or issuer shall ensure that coverage is provided with

8 respect to the services necessary for the secondary

9 consultation with any other specialist selected by the

10 attending physician for such purpose at no addi11 tional cost to the individual beyond that which the

12 individual would have paid if the specialist was par13 ticipating in the network of the plan or issuer.

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

15 shall be construed as requiring the provision of sec16 ondary consultations where the patient determines

17 not to seek such a consultation.

18 (d) PROHIBITION ON PENALTIES OR INCENTIVES.—

19 A group health plan, and a health insurance issuer pro20 viding health insurance coverage, may not—

21 (1) penalize or otherwise reduce or limit the re22 imbursement of a provider or specialist because the

23 provider or specialist provided care to a participant,

24 beneficiary, or enrollee in accordance with this sec25 tion;
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•S 1052 IS

1 (2) provide financial or other incentives to a

2 physician or specialist to induce the physician or

3 specialist to keep the length of inpatient stays of pa4 tients following a mastectomy, lumpectomy, or a

5 lymph node dissection for the treatment of breast

6 cancer below certain limits or to limit referrals for

7 secondary consultations; or

8 (3) provide financial or other incentives to a

9 physician or specialist to induce the physician or

10 specialist to refrain from referring a participant,

11 beneficiary, or enrollee for a secondary consultation

12 that would otherwise be covered by the plan or cov13 erage involved under subsection (c).

14 Subtitle C—Access to Information

15 SEC. 121. PATIENT ACCESS TO INFORMATION.

16 (a) REQUIREMENT.—

17 (1) DISCLOSURE.—

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

19 and a health insurance issuer that provides cov20 erage in connection with health insurance cov21 erage, shall provide for the disclosure to partici22 pants, beneficiaries, and enrollees—

23 (i) of the information described in

24 subsection (b) at the time of the initial en-
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•S 1052 IS

1 rollment of the participant, beneficiary, or

2 enrollee under the plan or coverage;

3 (ii) of such information on an annual

4 basis—

5 (I) in conjunction with the elec6 tion period of the plan or coverage if

7 the plan or coverage has such an elec8 tion period; or

9 (II) in the case of a plan or cov10 erage that does not have an election

11 period, in conjunction with the begin12 ning of the plan or coverage year; and

13 (iii) of information relating to any

14 material reduction to the benefits or infor15 mation described in such subsection or

16 subsection (c), in the form of a notice pro17 vided not later than 30 days before the

18 date on which the reduction takes effect.

19 (B) PARTICIPANTS, BENEFICIARIES, AND

20 ENROLLEES.—The disclosure required under

21 subparagraph (A) shall be provided—

22 (i) jointly to each participant, bene23 ficiary, and enrollee who reside at the same

24 address; or
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•S 1052 IS

1 (ii) in the case of a beneficiary or en2 rollee who does not reside at the same ad3 dress as the participant or another en4 rollee, separately to the participant or

5 other enrollees and such beneficiary or en6 rollee.

7 (2) PROVISION OF INFORMATION.—Information

8 shall be provided to participants, beneficiaries, and

9 enrollees under this section at the last known ad10 dress maintained by the plan or issuer with respect

11 to such participants, beneficiaries, or enrollees, to

12 the extent that such information is provided to par13 ticipants, beneficiaries, or enrollees via the United

14 States Postal Service or other private delivery serv15 ice.

16 (b) REQUIRED INFORMATION.—The informational

17 materials to be distributed under this section shall include

18 for each option available under the group health plan or

19 health insurance coverage the following:

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

21 benefits, including—

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

23 (B) specific preventive services covered

24 under the plan or coverage if such services are

25 covered;
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•S 1052 IS

1 (C) any specific exclusions or express limi2 tations of benefits described in section

3 104(b)(3)(C);

4 (D) any other benefit limitations, including

5 any annual or lifetime benefit limits and any

6 monetary limits or limits on the number of vis7 its, days, or services, and any specific coverage

8 exclusions; and

9 (E) any definition of medical necessity

10 used in making coverage determinations by the

11 plan, issuer, or claims administrator.

12 (2) COST SHARING.—A description of any cost13 sharing requirements, including—

14 (A) any premiums, deductibles, coinsur15 ance, copayment amounts, and liability for bal16 ance billing, for which the participant, bene17 ficiary, or enrollee will be responsible under

18 each option available under the plan;

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

20 for which the participant, beneficiary, or en21 rollee may be liable;

22 (C) any cost-sharing requirements for out23 of-network benefits or services received from

24 nonparticipating providers; and
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•S 1052 IS

1 (D) any additional cost-sharing or charges

2 for benefits and services that are furnished

3 without meeting applicable plan or coverage re4 quirements, such as prior authorization or

5 precertification.

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

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

8 any out-of-area coverage.

9 (4) PARTICIPATING PROVIDERS.—A directory of

10 participating providers (to the extent a plan or

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

14 provider, and information about how to inquire

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

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

18 description of any requirements and procedures to

19 be used by participants, beneficiaries, and enrollees

20 in selecting, accessing, or changing their primary

21 care provider, including providers both within and

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

23 out-of-network services), and the right to select a pe24 diatrician as a primary care provider under section
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•S 1052 IS

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

2 a child if such section applies.

3 (6) PREAUTHORIZATION REQUIREMENTS.—A

4 description of the requirements and procedures to be

5 used to obtain preauthorization for health services,

6 if such preauthorization is required.

7 (7) EXPERIMENTAL AND INVESTIGATIONAL

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

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

12 treatments are covered by the plan or issuer.

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

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

20 access to specialists care under section 114 if such

21 section applies.

22 (9) CLINICAL TRIALS.—A description of the cir23 cumstances and conditions under which participation

24 in clinical trials is covered under the terms and con25 ditions of the plan or coverage, and the right to ob-
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•S 1052 IS

1 tain coverage for approved clinical trials under sec2 tion 119 if such section applies.

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

4 plan or issuer provides coverage for prescription

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

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

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

13 (11) EMERGENCY SERVICES.—A summary of

14 the rules and procedures for accessing emergency

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

17 under the prudent layperson standard under section

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

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

22 the plan or issuer’s rules and procedures pertaining

23 to claims and appeals, a description of the rights

24 (including deadlines for exercising rights) of partici25 pants, beneficiaries, and enrollees under subtitle A
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•S 1052 IS

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

3 externally (including telephone numbers and mailing

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

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

8 State law.

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

12 issuer maintains such procedures.

13 (14) INFORMATION ON PLANS AND ISSUERS.—

14 The name, mailing address, and telephone number

15 or numbers of the plan administrator and the issuer

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

20 the benefits under the plan or coverage are provided

21 under a contract or policy of insurance issued by an

22 issuer, or whether benefits are provided directly by

23 the plan sponsor who bears the insurance risk.

24 (15) TRANSLATION SERVICES.—A summary de25 scription of any translation or interpretation services
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•S 1052 IS

1 (including the availability of printed information in

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

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

6 of how to access these items or services.

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

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

13 available to participants, beneficiaries, and enrollees.

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

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

18 paragraphs (1) through (16)) if such sections apply.

19 The description required under this paragraph may

20 be combined with the notices of the type described

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

23 with any other notice provision that the appropriate

24 Secretary determines may be combined, so long as

25 such combination does not result in any reduction
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•S 1052 IS

1 in the information that would otherwise be provided

2 to the recipient.

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

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

6 information (including telephone numbers and, if

7 available, Internet websites), shall be made available

8 upon request.

9 (c) ADDITIONAL INFORMATION.—The informational

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

11 beneficiary, or enrollee shall include for each option avail12 able under a group health plan or health insurance cov13 erage the following:

14 (1) STATUS OF PROVIDERS.—The State licen15 sure status of the plan or issuer’s participating

16 health care professionals and participating health

17 care facilities, and, if available, the education, train18 ing, specialty qualifications or certifications of such

19 professionals.

20 (2) COMPENSATION METHODS.—A summary

21 description by category of the applicable methods

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

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

24 for compensating prospective or treating health care

25 professionals (including primary care providers and
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•S 1052 IS

1 specialists) and facilities in connection with the pro2 vision of health care under the plan or coverage.

3 (3) PRESCRIPTION DRUGS.—Information about

4 whether a specific prescription medication is in5 cluded in the formulary of the plan or issuer, if the

6 plan or issuer uses a defined formulary.

7 (4) UTILIZATION REVIEW ACTIVITIES.—A de8 scription of procedures used and requirements (in9 cluding circumstances, timeframes, and appeals

10 rights) under any utilization review program under

11 sections 101 and 102, including any drug formulary

12 program under section 118.

13 (5) EXTERNAL APPEALS INFORMATION.—Ag14 gregate information on the number and outcomes of

15 external medical reviews, relative to the sample size

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

17 or under the coverage of the issuer.

18 (d) MANNER OF DISCLOSURE.—The information de19 scribed in this section shall be disclosed in an accessible

20 medium and format that is calculated to be understood

21 by a participant or enrollee.

22 (e) RULES OF CONSTRUCTION.—Nothing in this sec23 tion shall be construed to prohibit a group health plan,

24 or a health insurance issuer in connection with health in25 surance coverage, from—
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1 (1) distributing any other additional informa2 tion determined by the plan or issuer to be impor3 tant or necessary in assisting participants, bene4 ficiaries, and enrollees in the selection of a health

5 plan or health insurance coverage; and

6 (2) complying with the provisions of this section

7 by providing information in brochures, through the

8 Internet or other electronic media, or through other

9 similar means, so long as—

10 (A) the disclosure of such information in

11 such form is in accordance with requirements

12 as the appropriate Secretary may impose, and

13 (B) in connection with any such disclosure

14 of information through the Internet or other

15 electronic media—

16 (i) the recipient has affirmatively con17 sented to the disclosure of such informa18 tion in such form,

19 (ii) the recipient is capable of access20 ing the information so disclosed on the re21 cipient’s individual workstation or at the

22 recipient’s home,

23 (iii) the recipient retains an ongoing

24 right to receive paper disclosure of such in25 formation and receives, in advance of any
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1 attempt at disclosure of such information

2 to him or her through the Internet or

3 other electronic media, notice in printed

4 form of such ongoing right and of the

5 proper software required to view informa6 tion so disclosed, and

7 (iv) the plan administrator appro8 priately ensures that the intended recipient

9 is receiving the information so disclosed

10 and provides the information in printed

11 form if the information is not received.

12 Subtitle D—Protecting the Doctor13 Patient Relationship

14 SEC. 131. PROHIBITION OF INTERFERENCE WITH CERTAIN

15 MEDICAL COMMUNICATIONS.

16 (a) GENERAL RULE.—The provisions of any contract

17 or agreement, or the operation of any contract or agree18 ment, between a group health plan or health insurance

19 issuer in relation to health insurance coverage (including

20 any partnership, association, or other organization that

21 enters into or administers such a contract or agreement)

22 and a health care provider (or group of health care pro23 viders) shall not prohibit or otherwise restrict a health

24 care professional from advising such a participant, bene25 ficiary, or enrollee who is a patient of the professional
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1 about the health status of the individual or medical care

2 or treatment for the individual’s condition or disease, re3 gardless of whether benefits for such care or treatment

4 are provided under the plan or coverage, if the professional

5 is acting within the lawful scope of practice.

6 (b) NULLIFICATION.—Any contract provision or

7 agreement that restricts or prohibits medical communica8 tions in violation of subsection (a) shall be null and void.

9 SEC. 132. PROHIBITION OF DISCRIMINATION AGAINST PRO10 VIDERS BASED ON LICENSURE.

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

12 insurance issuer with respect to health insurance coverage,

13 shall not discriminate with respect to participation or in14 demnification as to any provider who is acting within the

15 scope of the provider’s license or certification under appli16 cable State law, solely on the basis of such license or cer17 tification.

18 (b) CONSTRUCTION.—Subsection (a) shall not be

19 construed—

20 (1) as requiring the coverage under a group

21 health plan or health insurance coverage of a par22 ticular benefit or service or to prohibit a plan or

23 issuer from including providers only to the extent

24 necessary to meet the needs of the plan’s or issuer’s

25 participants, beneficiaries, or enrollees or from es-
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1 tablishing any measure designed to maintain quality

2 and control costs consistent with the responsibilities

3 of the plan or issuer;

4 (2) to override any State licensure or scope-of5 practice law; or

6 (3) as requiring a plan or issuer that offers net7 work coverage to include for participation every will8 ing provider who meets the terms and conditions of

9 the plan or issuer.

10 SEC. 133. PROHIBITION AGAINST IMPROPER INCENTIVE

11 ARRANGEMENTS.

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

13 insurance issuer offering health insurance coverage may

14 not operate any physician incentive plan (as defined in

15 subparagraph (B) of section 1876(i)(8) of the Social Secu16 rity Act) unless the requirements described in clauses (i),

17 (ii)(I), and (iii) of subparagraph (A) of such section are

18 met with respect to such a plan.

19 (b) APPLICATION.—For purposes of carrying out

20 paragraph (1), any reference in section 1876(i)(8) of the

21 Social Security Act to the Secretary, an eligible organiza22 tion, or an individual enrolled with the organization shall

23 be treated as a reference to the applicable authority, a

24 group health plan or health insurance issuer, respectively,
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1 and a participant, beneficiary, or enrollee with the plan

2 or organization, respectively.

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

4 construed as prohibiting all capitation and similar ar5 rangements or all provider discount arrangements.

6 SEC. 134. PAYMENT OF CLAIMS.

7 A group health plan, and a health insurance issuer

8 offering group health insurance coverage, shall provide for

9 prompt payment of claims submitted for health care serv10 ices or supplies furnished to a participant, beneficiary, or

11 enrollee with respect to benefits covered by the plan or

12 issuer, in a manner consistent with the provisions of sec13 tion 1842(c)(2) of the Social Security Act (42 U.S.C.

14 1395u(c)(2)).

15 SEC. 135. PROTECTION FOR PATIENT ADVOCACY.

16 (a) PROTECTION FOR USE OF UTILIZATION REVIEW

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

18 health insurance issuer with respect to the provision of

19 health insurance coverage, may not retaliate against a par20 ticipant, beneficiary, enrollee, or health care provider

21 based on the participant’s, beneficiary’s, enrollee’s or pro22 vider’s use of, or participation in, a utilization review proc23 ess or a grievance process of the plan or issuer (including

24 an internal or external review or appeal process) under

25 this title.
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1 (b) PROTECTION FOR QUALITY ADVOCACY BY

2 HEALTH CARE PROFESSIONALS.—

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

4 health insurance issuer may not retaliate or dis5 criminate against a protected health care profes6 sional because the professional in good faith—

7 (A) discloses information relating to the

8 care, services, or conditions affecting one or

9 more participants, beneficiaries, or enrollees of

10 the plan or issuer to an appropriate public reg11 ulatory agency, an appropriate private accredi12 tation body, or appropriate management per13 sonnel of the plan or issuer; or

14 (B) initiates, cooperates, or otherwise par15 ticipates in an investigation or proceeding by

16 such an agency with respect to such care, serv17 ices, or conditions.

18 If an institutional health care provider is a partici19 pating provider with such a plan or issuer or other20 wise receives payments for benefits provided by such

21 a plan or issuer, the provisions of the previous sen22 tence shall apply to the provider in relation to care,

23 services, or conditions affecting one or more patients

24 within an institutional health care provider in the

25 same manner as they apply to the plan or issuer in
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1 relation to care, services, or conditions provided to

2 one or more participants, beneficiaries, or enrollees;

3 and for purposes of applying this sentence, any ref4 erence to a plan or issuer is deemed a reference to

5 the institutional health care provider.

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

7 paragraph (1), a protected health care professional

8 is considered to be acting in good faith with respect

9 to disclosure of information or participation if, with

10 respect to the information disclosed as part of the

11 action—

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

13 personal knowledge and is consistent with that

14 degree of learning and skill ordinarily possessed

15 by health care professionals with the same li16 censure or certification and the same experi17 ence;

18 (B) the professional reasonably believes the

19 information to be true;

20 (C) the information evidences either a vio21 lation of a law, rule, or regulation, of an appli22 cable accreditation standard, or of a generally

23 recognized professional or clinical standard or

24 that a patient is in imminent hazard of loss of

25 life or serious injury; and
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1 (D) subject to subparagraphs (B) and (C)

2 of paragraph (3), the professional has followed

3 reasonable internal procedures of the plan,

4 issuer, or institutional health care provider es5 tablished for the purpose of addressing quality

6 concerns before making the disclosure.

7 (3) EXCEPTION AND SPECIAL RULE.—

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

9 does not protect disclosures that would violate

10 Federal or State law or diminish or impair the

11 rights of any person to the continued protection

12 of confidentiality of communications provided

13 by such law.

14 (B) NOTICE OF INTERNAL PROCEDURES.—

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

16 apply unless the internal procedures involved

17 are reasonably expected to be known to the

18 health care professional involved. For purposes

19 of this subparagraph, a health care professional

20 is reasonably expected to know of internal pro21 cedures if those procedures have been made

22 available to the professional through distribu23 tion or posting.
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1 (C) INTERNAL PROCEDURE EXCEPTION.—

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

3 not apply if—

4 (i) the disclosure relates to an immi5 nent hazard of loss of life or serious injury

6 to a patient;

7 (ii) the disclosure is made to an ap8 propriate private accreditation body pursu9 ant to disclosure procedures established by

10 the body; or

11 (iii) the disclosure is in response to an

12 inquiry made in an investigation or pro13 ceeding of an appropriate public regulatory

14 agency and the information disclosed is

15 limited to the scope of the investigation or

16 proceeding.

17 (4) ADDITIONAL CONSIDERATIONS.—It shall

18 not be a violation of paragraph (1) to take an ad19 verse action against a protected health care profes20 sional if the plan, issuer, or provider taking the ad21 verse action involved demonstrates that it would

22 have taken the same adverse action even in the ab23 sence of the activities protected under such para24 graph.
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1 (5) NOTICE.—A group health plan, health in2 surance issuer, and institutional health care provider

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

4 the Secretary of Labor, setting forth excerpts from,

5 or summaries of, the pertinent provisions of this

6 subsection and information pertaining to enforce7 ment of such provisions.

8 (6) CONSTRUCTIONS.—

9 (A) DETERMINATIONS OF COVERAGE.—

10 Nothing in this subsection shall be construed to

11 prohibit a plan or issuer from making a deter12 mination not to pay for a particular medical

13 treatment or service or the services of a type of

14 health care professional.

15 (B) ENFORCEMENT OF PEER REVIEW PRO16 TOCOLS AND INTERNAL PROCEDURES.—Noth17 ing in this subsection shall be construed to pro18 hibit a plan, issuer, or provider from estab19 lishing and enforcing reasonable peer review or

20 utilization review protocols or determining

21 whether a protected health care professional has

22 complied with those protocols or from estab23 lishing and enforcing internal procedures for

24 the purpose of addressing quality concerns.
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1 (C) RELATION TO OTHER RIGHTS.—Noth2 ing in this subsection shall be construed to

3 abridge rights of participants, beneficiaries, en4 rollees, and protected health care professionals

5 under other applicable Federal or State laws.

6 (7) PROTECTED HEALTH CARE PROFESSIONAL

7 DEFINED.—For purposes of this subsection, the

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

9 individual who is a licensed or certified health care

10 professional and who—

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

12 health insurance issuer, is an employee of the

13 plan or issuer or has a contract with the plan

14 or issuer for provision of services for which ben15 efits are available under the plan or issuer; or

16 (B) with respect to an institutional health

17 care provider, is an employee of the provider or

18 has a contract or other arrangement with the

19 provider respecting the provision of health care

20 services.

21 Subtitle E—Definitions

22 SEC. 151. DEFINITIONS.

23 (a) INCORPORATION OF GENERAL DEFINITIONS.—

24 Except as otherwise provided, the provisions of section

25 2791 of the Public Health Service Act shall apply for pur-
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1 poses of this title in the same manner as they apply for

2 purposes of title XXVII of such Act.

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

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

5 Human Services, in consultation with the Secretary of

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

7 Secretary of Health and Human Services in relation to

8 carrying out this title under sections 2706 and 2751 of

9 the Public Health Service Act and the Secretary of Labor

10 in relation to carrying out this title under section 713 of

11 the Employee Retirement Income Security Act of 1974.

12 (c) ADDITIONAL DEFINITIONS.—For purposes of this

13 title:

14 (1) APPLICABLE AUTHORITY.—The term ‘‘ap15 plicable authority’’ means—

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

17 Secretary of Health and Human Services and

18 the Secretary of Labor; and

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

20 with respect to a specific provision of this title,

21 the applicable State authority (as defined in

22 section 2791(d) of the Public Health Service

23 Act), or the Secretary of Health and Human

24 Services, if such Secretary is enforcing such
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1 provision under section 2722(a)(2) or

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

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

4 with respect to health insurance coverage offered by

5 a health insurance issuer, an individual enrolled with

6 the issuer to receive such coverage.

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

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

9 section 733(a) of the Employee Retirement Income

10 Security Act of 1974, except that such term includes

11 a employee welfare benefit plan treated as a group

12 health plan under section 732(d) of such Act or de13 fined as such a plan under section 607(1) of such

14 Act.

15 (4) HEALTH CARE PROFESSIONAL.—The term

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

17 is licensed, accredited, or certified under State law

18 to provide specified health care services and who is

19 operating within the scope of such licensure, accredi20 tation, or certification.

21 (5) HEALTH CARE PROVIDER.—The term

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

23 health care professional, as well as an institutional

24 or other facility or agency that provides health care

25 services and that is licensed, accredited, or certified
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1 to provide health care items and services under ap2 plicable State law.

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

4 with respect to a group health plan or health insur5 ance issuer offering health insurance coverage, the

6 participating health care professionals and providers

7 through whom the plan or issuer provides health

8 care items and services to participants, beneficiaries,

9 or enrollees.

10 (7) NONPARTICIPATING.—The term ‘‘non11 participating’’ means, with respect to a health care

12 provider that provides health care items and services

13 to a participant, beneficiary, or enrollee under group

14 health plan or health insurance coverage, a health

15 care provider that is not a participating health care

16 provider with respect to such items and services.

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

18 means, with respect to a health care provider that

19 provides health care items and services to a partici20 pant, beneficiary, or enrollee under group health

21 plan or health insurance coverage offered by a

22 health insurance issuer, a health care provider that

23 furnishes such items and services under a contract

24 or other arrangement with the plan or issuer.
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1 (9) PRIOR AUTHORIZATION.—The term ‘‘prior

2 authorization’’ means the process of obtaining prior

3 approval from a health insurance issuer or group

4 health plan for the provision or coverage of medical

5 services.

6 (10) TERMS AND CONDITIONS.—The term

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

8 group health plan or health insurance coverage, re9 quirements imposed under this title with respect to

10 the plan or coverage.

11 SEC. 152. PREEMPTION; STATE FLEXIBILITY; CONSTRUC12 TION.

13 (a) CONTINUED APPLICABILITY OF STATE LAW

14 WITH RESPECT TO HEALTH INSURANCE ISSUERS.—

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

16 this title shall not be construed to supersede any

17 provision of State law which establishes, implements,

18 or continues in effect any standard or requirement

19 solely relating to health insurance issuers (in connec20 tion with group health insurance coverage or other21 wise) except to the extent that such standard or re22 quirement prevents the application of a requirement

23 of this title.

24 (2) CONTINUED PREEMPTION WITH RESPECT

25 TO GROUP HEALTH PLANS.—Nothing in this title
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1 shall be construed to affect or modify the provisions

2 of section 514 of the Employee Retirement Income

3 Security Act of 1974 with respect to group health

4 plans.

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

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

7 availability of, all categories of licensed health care

8 providers and services shall not be treated as pre9 venting the application of any requirement of this

10 title.

11 (b) APPLICATION OF SUBSTANTIALLY EQUIVALENT

12 STATE LAWS.—

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

14 that imposes, with respect to health insurance cov15 erage offered by a health insurance issuer and with

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

17 governmental plan, a requirement that is substan18 tially equivalent (within the meaning of subsection

19 (c)) to a patient protection requirement (as defined

20 in paragraph (3)) and does not prevent the applica21 tion of other requirements under this Act (except in

22 the case of other substantially equivalent require23 ments), in applying the requirements of this title

24 under section 2707 and 2753 (as applicable) of the
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1 Public Health Service Act (as added by title II),

2 subject to subsection (a)(2)—

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

4 being superseded under subsection (a); and

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

6 patient protection requirement otherwise appli7 cable with respect to health insurance coverage

8 and non-Federal governmental plans.

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

10 plan covered under title I of the Employee Retire11 ment Income Security Act of 1974, paragraph (1)

12 shall be construed to apply only with respect to the

13 health insurance coverage (if any) offered in connec14 tion with the plan.

15 (3) PATIENT PROTECTION REQUIREMENT DE16 FINED.—For purposes of this section, the term ‘‘pa17 tient protection requirement’’ means a requirement

18 under this title, and includes (as a single require19 ment) a group or related set of requirements under

20 a section or similar unit under this title.

21 (c) DETERMINATIONS OF SUBSTANTIAL EQUIVA22 LENCE.—

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

24 submit to the Secretary a certification that a State

25 law provides for patient protections that are at least
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1 substantially equivalent to one or more patient pro2 tection requirements. Such certification shall be ac3 companied by such information as may be required

4 to permit the Secretary to make the determination

5 described in paragraph (2)(A).

6 (2) REVIEW.—

7 (A) IN GENERAL.—The Secretary shall

8 promptly review a certification submitted under

9 paragraph (1) with respect to a State law to de10 termine if the State law provides for at least

11 substantially equivalent and effective patient

12 protections to the patient protection require13 ment (or requirements) to which the law re14 lates.

15 (B) APPROVAL DEADLINES.—

16 (i) INITIAL REVIEW.—Such a certifi17 cation is considered approved unless the

18 Secretary notifies the State in writing,

19 within 90 days after the date of receipt of

20 the certification, that the certification is

21 disapproved (and the reasons for dis22 approval) or that specified additional infor23 mation is needed to make the determina24 tion described in subparagraph (A).
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1 (ii) ADDITIONAL INFORMATION.—

2 With respect to a State that has been noti3 fied by the Secretary under clause (i) that

4 specified additional information is needed

5 to make the determination described in

6 subparagraph (A), the Secretary shall

7 make the determination within 60 days

8 after the date on which such specified ad9 ditional information is received by the Sec10 retary.

11 (3) APPROVAL.—

12 (A) IN GENERAL.—The Secretary shall ap13 prove a certification under paragraph (1)

14 unless—

15 (i) the State fails to provide sufficient

16 information to enable the Secretary to

17 make a determination under paragraph

18 (2)(A); or

19 (ii) the Secretary determines that the

20 State law involved does not provide for pa21 tient protections that are at least substan22 tially equivalent to and as effective as the

23 patient protection requirement (or require24 ments) to which the law relates.
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1 (B) STATE CHALLENGE.—A State that has

2 a certification disapproved by the Secretary

3 under subparagraph (A) may challenge such

4 disapproval in the appropriate United States

5 district court.

6 (4) CONSTRUCTION.—Nothing in this sub7 section shall be construed as preventing the certifi8 cation (and approval of certification) of a State law

9 under this subsection solely because it provides for

10 greater protections for patients than those protec11 tions otherwise required to establish substantial

12 equivalence.

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

14 (1) STATE LAW.—The term ‘‘State law’’ in15 cludes all laws, decisions, rules, regulations, or other

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

17 A law of the United States applicable only to the

18 District of Columbia shall be treated as a State law

19 rather than a law of the United States.

20 (2) STATE.—The term ‘‘State’’ includes a

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

22 Virgin Islands, Guam, American Samoa, the North23 ern Mariana Islands, any political subdivisions of

24 such, or any agency or instrumentality of such.
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1 SEC. 153. EXCLUSIONS.

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

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

4 a health insurance issuer offering health insurance cov5 erage to include specific items and services under the

6 terms of such a plan or coverage, other than those pro7 vided under the terms and conditions of such plan or cov8 erage.

9 (b) EXCLUSION FROM ACCESS TO CARE MANAGED

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

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

12 111 through 117 shall not apply to a group health

13 plan or health insurance coverage if the only cov14 erage offered under the plan or coverage is fee-for15 service coverage (as defined in paragraph (2)).

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

17 For purposes of this subsection, the term ‘‘fee-for18 service coverage’’ means coverage under a group

19 health plan or health insurance coverage that—

20 (A) reimburses hospitals, health profes21 sionals, and other providers on a fee-for-service

22 basis without placing the provider at financial

23 risk;

24 (B) does not vary reimbursement for such

25 a provider based on an agreement to contract
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1 terms and conditions or the utilization of health

2 care items or services relating to such provider;

3 (C) allows access to any provider that is

4 lawfully authorized to provide the covered serv5 ices and that agrees to accept the terms and

6 conditions of payment established under the

7 plan or by the issuer; and

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

9 require prior authorization before providing for

10 any health care services.

11 SEC. 154. COVERAGE OF LIMITED SCOPE PLANS.

12 Only for purposes of applying the requirements of

13 this title under sections 2707 and 2753 of the Public

14 Health Service Act and section 714 of the Employee Re15 tirement Income Security Act of 1974, section

16 2791(c)(2)(A), and section 733(c)(2)(A) of the Employee

17 Retirement Income Security Act of 1974 shall be deemed

18 not to apply.

19 SEC. 155. REGULATIONS.

20 The Secretaries of Health and Human Services and

21 Labor shall issue such regulations as may be necessary

22 or appropriate to carry out this title. Such regulations

23 shall be issued consistent with section 104 of Health In24 surance Portability and Accountability Act of 1996. Such

25 Secretaries may promulgate any interim final rules as the
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1 Secretaries determine are appropriate to carry out this

2 title.

3 SEC. 156. INCORPORATION INTO PLAN OR COVERAGE DOC4 UMENTS.

5 The requirements of this title with respect to a group

6 health plan or health insurance coverage are deemed to

7 be incorporated into, and made a part of, such plan or

8 the policy, certificate, or contract providing such coverage

9 and are enforceable under law as if directly included in

10 the documentation of such plan or such policy, certificate,

11 or contract.

12 TITLE II—APPLICATION OF

13 QUALITY CARE STANDARDS

14 TO GROUP HEALTH PLANS

15 AND HEALTH INSURANCE

16 COVERAGE UNDER THE PUB17 LIC HEALTH SERVICE ACT

18 SEC. 201. APPLICATION TO GROUP HEALTH PLANS AND

19 GROUP HEALTH INSURANCE COVERAGE.

20 (a) IN GENERAL.—Subpart 2 of part A of title

21 XXVII of the Public Health Service Act is amended by

22 adding at the end the following new section:

23 ‘‘SEC. 2707. PATIENT PROTECTION STANDARDS.

24 ‘‘Each group health plan shall comply with patient

25 protection requirements under title I of the Bipartisan Pa-
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1 tient Protection Act, and each health insurance issuer

2 shall comply with patient protection requirements under

3 such title with respect to group health insurance coverage

4 it offers, and such requirements shall be deemed to be in5 corporated into this subsection.’’.

6 (b) CONFORMING AMENDMENT.—Section

7 2721(b)(2)(A) of such Act (42 U.S.C. 300gg–21(b)(2)(A))

8 is amended by inserting ‘‘(other than section 2707)’’ after

9 ‘‘requirements of such subparts’’.

10 SEC. 202. APPLICATION TO INDIVIDUAL HEALTH INSUR11 ANCE COVERAGE.

12 Part B of title XXVII of the Public Health Service

13 Act is amended by inserting after section 2752 the fol14 lowing new section:

15 ‘‘SEC. 2753. PATIENT PROTECTION STANDARDS.

16 ‘‘Each health insurance issuer shall comply with pa17 tient protection requirements under title I of the Bipar18 tisan Patient Protection Act with respect to individual

19 health insurance coverage it offers, and such requirements

20 shall be deemed to be incorporated into this subsection.’’.
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1 TITLE III—AMENDMENTS TO

2 THE EMPLOYEE RETIREMENT

3 INCOME SECURITY ACT OF

4 1974

5 SEC. 301. APPLICATION OF PATIENT PROTECTION STAND6 ARDS TO GROUP HEALTH PLANS AND GROUP

7 HEALTH INSURANCE COVERAGE UNDER THE

8 EMPLOYEE RETIREMENT INCOME SECURITY

9 ACT OF 1974.

10 Subpart B of part 7 of subtitle B of title I of the

11 Employee Retirement Income Security Act of 1974 is

12 amended by adding at the end the following new section:

13 ‘‘SEC. 714. PATIENT PROTECTION STANDARDS.

14 ‘‘(a) IN GENERAL.—Subject to subsection (b), a

15 group health plan (and a health insurance issuer offering

16 group health insurance coverage in connection with such

17 a plan) shall comply with the requirements of title I of

18 the Bipartisan Patient Protection Act (as in effect as of

19 the date of the enactment of such Act), and such require20 ments shall be deemed to be incorporated into this sub21 section.

22 ‘‘(b) PLAN SATISFACTION OF CERTAIN REQUIRE23 MENTS.—

24 ‘‘(1) SATISFACTION OF CERTAIN REQUIRE25 MENTS THROUGH INSURANCE.—For purposes of
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1 subsection (a), insofar as a group health plan pro2 vides benefits in the form of health insurance cov3 erage through a health insurance issuer, the plan

4 shall be treated as meeting the following require5 ments of title I of the Bipartisan Patient Protection

6 Act with respect to such benefits and not be consid7 ered as failing to meet such requirements because of

8 a failure of the issuer to meet such requirements so

9 long as the plan sponsor or its representatives did

10 not cause such failure by the issuer:

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

12 choice option).

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

14 health care professional).

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

16 emergency care).

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

18 to specialists).

19 ‘‘(E) Section 115 (relating to patient ac20 cess to obstetrical and gynecological care).

21 ‘‘(F) Section 116 (relating to access to pe22 diatric care).

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

24 care), but only insofar as a replacement issuer

25 assumes the obligation for continuity of care.
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1 ‘‘(H) Section 118 (relating to access to

2 needed prescription drugs).

3 ‘‘(I) Section 119 (relating to coverage for

4 individuals participating in approved clinical

5 trials).

6 ‘‘(J) Section 120 (relating to required cov7 erage for minimum hospital stay for

8 mastectomies and lymph node dissections for

9 the treatment of breast cancer and coverage for

10 secondary consultations).

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

12 claims).

13 ‘‘(2) INFORMATION.—With respect to informa14 tion required to be provided or made available under

15 section 121 of the Bipartisan Patient Protection

16 Act, in the case of a group health plan that provides

17 benefits in the form of health insurance coverage

18 through a health insurance issuer, the Secretary

19 shall determine the circumstances under which the

20 plan is not required to provide or make available the

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

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

23 issuer is obligated to provide and make available (or

24 provides and makes available) such information.
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1 ‘‘(3) INTERNAL APPEALS.—With respect to the

2 internal appeals process required to be established

3 under section 103 of such Act, in the case of a

4 group health plan that provides benefits in the form

5 of health insurance coverage through a health insur6 ance issuer, the Secretary shall determine the cir7 cumstances under which the plan is not required to

8 provide for such process and system (and is not lia9 ble for the issuer’s failure to provide for such proc10 ess and system), if the issuer is obligated to provide

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

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

13 of the Secretary, insofar as a group health plan en14 ters into a contract with a qualified external appeal

15 entity for the conduct of external appeal activities in

16 accordance with section 104 of such Act, the plan

17 shall be treated as meeting the requirement of such

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

19 meet any requirements under such section.

20 ‘‘(5) APPLICATION TO PROHIBITIONS.—Pursu21 ant to rules of the Secretary, if a health insurance

22 issuer offers health insurance coverage in connection

23 with a group health plan and takes an action in vio24 lation of any of the following sections of the Bipar25 tisan Patient Protection Act, the group health plan
136

•S 1052 IS

1 shall not be liable for such violation unless the plan

2 caused such violation:

3 ‘‘(A) Section 131 (relating to prohibition of

4 interference with certain medical communica5 tions).

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

7 of discrimination against providers based on li8 censure).

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

10 against improper incentive arrangements).

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

12 for patient advocacy).

13 ‘‘(6) CONSTRUCTION.—Nothing in this sub14 section shall be construed to affect or modify the re15 sponsibilities of the fiduciaries of a group health

16 plan under part 4 of subtitle B.

17 ‘‘(7) TREATMENT OF SUBSTANTIALLY EQUIVA18 LENT 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 is

24 substantially equivalent (as determined under section
137

•S 1052 IS

1 152(c) of such Act) to the requirement in such sec2 tion 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.
138

•S 1052 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 1052 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. 302. 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 subsection:

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—
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•S 1052 IS

1 ‘‘(i) upon consideration of a claim for

2 benefits of a participant or beneficiary

3 under section 102 of the Bipartisan Pa4 tient Protection Act of 2001 (relating to

5 procedures for initial claims for benefits

6 and prior authorization determinations) or

7 upon review of a denial of such a claim

8 under section 103 of such Act (relating to

9 internal appeal of a denial of a claim for

10 benefits), fails to exercise ordinary care in

11 making a decision—

12 ‘‘(I) regarding whether an item

13 or service is covered under the terms

14 and conditions of the plan or cov15 erage,

16 ‘‘(II) regarding whether an indi17 vidual is a participant or beneficiary

18 who is enrolled under the terms and

19 conditions of the plan or coverage (in20 cluding the applicability of any wait21 ing period under the plan or cov22 erage), or

23 ‘‘(III) as to the application of

24 cost-sharing requirements or the ap25 plication of a specific exclusion or ex-
141

•S 1052 IS

1 press limitation on the amount, dura2 tion, or scope of coverage of items or

3 services under the terms and condi4 tions of the plan or coverage, or

5 ‘‘(ii) otherwise fails to exercise ordi6 nary care in the performance of a duty

7 under the terms and conditions of the plan

8 with respect to a participant or beneficiary,

9 and

10 ‘‘(B) such failure is a proximate cause of

11 personal injury to, or the death of, the partici12 pant or beneficiary,

13 such person shall be liable to the participant or ben14 eficiary (or the estate of such participant or bene15 ficiary) for economic and noneconomic damages (but

16 not exemplary or punitive damages) in connection

17 with such personal injury or death.

18 ‘‘(2) CAUSE OF ACTION MUST NOT INVOLVE

19 MEDICALLY REVIEWABLE DECISION.—

20 ‘‘(A) IN GENERAL.—A cause of action is

21 established under paragraph (1)(A) only if the

22 decision referred to in clause (i) or the failure

23 described in clause (ii) does not include a medi24 cally reviewable decision.
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•S 1052 IS

1 ‘‘(B) MEDICALLY REVIEWABLE DECI2 SION.—For purposes of this subsection, the

3 term ‘medically reviewable decision’ means a de4 nial of a claim for benefits under the plan

5 which is described in section 104(d)(2) of the

6 Bipartisan Patient Protection Act of 2001 (re7 lating to medically reviewable decisions).

8 ‘‘(3) LIMITATION REGARDING CERTAIN TYPES

9 OF ACTIONS SAVED FROM PREEMPTION OF STATE

10 LAW.—A cause of action is not established under

11 paragraph (1)(A) in connection with a failure de12 scribed in paragraph (1)(A) to the extent that a

13 cause of action under State law (as defined in sec14 tion 514(c)) for such failure would not be preempted

15 under section 514.

16 ‘‘(4) DEFINITIONS.—For purposes of this sub17 section.—

18 ‘‘(A) ORDINARY CARE.—The term ‘ordi19 nary care’ means—

20 ‘‘(i) with respect to a determination

21 on a claim for benefits, that degree of care,

22 skill, and diligence that a reasonable and

23 prudent individual would exercise in mak24 ing a fair determination on a claim for
143

•S 1052 IS

1 benefits of like kind to the claim involved;

2 and

3 ‘‘(ii) with respect to the performance

4 of a duty, that degree of care, skill, and

5 diligence that a reasonable and prudent in6 dividual would exercise in performing the

7 duty or a duty of like character.

8 ‘‘(B) PERSONAL INJURY.—The term ‘per9 sonal injury’ means a physical injury and in10 cludes an injury arising out of the treatment

11 (or failure to treat) a mental illness or disease.

12 ‘‘(C) CLAIM FOR BENEFITS; DENIAL.—The

13 terms ‘claim for benefits’ and ‘denial of a claim

14 for benefits’ have the meanings provided such

15 terms in section 102(e) of the Bipartisan Pa16 tient Protection Act of 2001.

17 ‘‘(D) TERMS AND CONDITIONS.—The term

18 ‘terms and conditions’ includes, with respect to

19 a group health plan or health insurance cov20 erage, requirements imposed under title I of the

21 Bipartisan Patient Protection Act of 2001 or

22 under part 6 or 7.

23 ‘‘(E) GROUP HEALTH PLAN AND OTHER

24 RELATED TERMS.—The provisions of sections

25 732(d) and 733 apply for purposes of this sub-
144

•S 1052 IS

1 section in the same manner as they apply for

2 purposes of part 7, except that the term ‘group

3 health plan’ includes a group health plan (as

4 defined in section 607(1)).

5 ‘‘(5) EXCLUSION OF EMPLOYERS AND OTHER

6 PLAN SPONSORS.—

7 ‘‘(A) CAUSES OF ACTION AGAINST EM8 PLOYERS AND PLAN SPONSORS PRECLUDED.—

9 Subject to subparagraph (B), paragraph (1)(A)

10 does not authorize a cause of action against an

11 employer or other plan sponsor maintaining the

12 plan (or against an employee of such an em13 ployer or sponsor acting within the scope of em14 ployment).

15 ‘‘(B) CERTAIN CAUSES OF ACTION PER16 MITTED.—Notwithstanding subparagraph (A),

17 a cause of action may arise against an employer

18 or other plan sponsor (or against an employee

19 of such an employer or sponsor acting within

20 the scope of employment)—

21 ‘‘(i) under clause (i) of paragraph

22 (1)(A), to the extent there was direct par23 ticipation by the employer or other plan

24 sponsor (or employee) in the decision of

25 the plan under section 102 of the Bipar-
145

•S 1052 IS

1 tisan Patient Protection Act of 2001 upon

2 consideration of a claim for benefits or

3 under section 103 of such Act upon review

4 of a denial of a claim for benefits, or

5 ‘‘(ii) under clause (ii) of paragraph

6 (1)(A), to the extent there was direct par7 ticipation by the employer or other plan

8 sponsor (or employee) in the failure de9 scribed in such clause.

10 ‘‘(C) DIRECT PARTICIPATION.—

11 ‘‘(i) DIRECT PARTICIPATION IN DECI12 SIONS.—For purposes of subparagraph

13 (B), the term ‘direct participation’ means,

14 in connection with a decision described in

15 clause (i) of paragraph (1)(A) or a failure

16 described in clause (ii) of such paragraph,

17 the actual making of such decision or the

18 actual exercise of control in making such

19 decision or in the conduct constituting the

20 failure.

21 ‘‘(ii) RULES OF CONSTRUCTION.—For

22 purposes of clause (i), the employer or plan

23 sponsor (or employee) shall not be con24 strued to be engaged in direct participation

25 because of any form of decisionmaking or
146

•S 1052 IS

1 other conduct that is merely collateral or

2 precedent to the decision described in

3 clause (i) of paragraph (1)(A) on a par4 ticular claim for benefits of a participant

5 or beneficiary or that is merely collateral

6 or precedent to the conduct constituting a

7 failure described in clause (ii) of paragraph

8 (1)(A) with respect to a particular partici9 pant or beneficiary, including (but not lim10 ited to)—

11 ‘‘(I) any participation by the em12 ployer or other plan sponsor (or em13 ployee) in the selection of the group

14 health plan or health insurance cov15 erage involved or the third party ad16 ministrator or other agent;

17 ‘‘(II) any engagement by the em18 ployer or other plan sponsor (or em19 ployee) in any cost-benefit analysis

20 undertaken in connection with the se21 lection of, or continued maintenance

22 of, the plan or coverage involved;

23 ‘‘(III) any participation by the

24 employer or other plan sponsor (or

25 employee) in the process of creating,
147

•S 1052 IS

1 continuing, modifying, or terminating

2 the plan or any benefit under the

3 plan, if such process was not substan4 tially focused solely on the particular

5 situation of the participant or bene6 ficiary referred to in paragraph

7 (1)(A); and

8 ‘‘(IV) any participation by the

9 employer or other plan sponsor (or

10 employee) in the design of any benefit

11 under the plan, including the amount

12 of copayment and limits connected

13 with such benefit.

14 ‘‘(iv) IRRELEVANCE OF CERTAIN COL15 LATERAL EFFORTS MADE BY EMPLOYER

16 OR PLAN SPONSOR.—For purposes of this

17 subparagraph, an employer or plan sponsor

18 shall not be treated as engaged in direct

19 participation in a decision with respect to

20 any claim for benefits or denial thereof in

21 the case of any particular participant or

22 beneficiary solely by reason of—

23 ‘‘(I) any efforts that may have

24 been made by the employer or plan

25 sponsor to advocate for authorization
148

•S 1052 IS

1 of coverage for that or any other par2 ticipant or beneficiary (or any group

3 of participants or beneficiaries), or

4 ‘‘(II) any provision that may

5 have been made by the employer or

6 plan sponsor for benefits which are

7 not covered under the terms and con8 ditions of the plan for that or any

9 other participant or beneficiary (or

10 any group of participants or bene11 ficiaries).

12 ‘‘(6) EXCLUSION OF PHYSICIANS AND OTHER

13 HEALTH CARE PROFESSIONALS.—

14 ‘‘(A) IN GENERAL.—No treating physician

15 or other treating health care professional of the

16 participant or beneficiary, and no person acting

17 under the direction of such a physician or

18 health care professional, shall be liable under

19 paragraph (1) for the performance of, or the

20 failure to perform, any non-medically reviewable

21 duty of the plan, the plan sponsor, or any

22 health insurance issuer offering health insur23 ance coverage in connection with the plan.

24 ‘‘(B) DEFINITIONS.—For purposes of sub25 paragraph (A)—
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•S 1052 IS

1 ‘‘(i) HEALTH CARE PROFESSIONAL.—

2 The term ‘health care professional’ means

3 an individual who is licensed, accredited, or

4 certified under State law to provide speci5 fied health care services and who is oper6 ating within the scope of such licensure,

7 accreditation, or certification.

8 ‘‘(ii) NON-MEDICALLY REVIEWABLE

9 DUTY.—The term ‘non-medically review10 able duty’ means a duty the discharge of

11 which does not include the making of a

12 medically reviewable decision.

13 ‘‘(7) EXCLUSION OF HOSPITALS.—No treating

14 hospital of the participant or beneficiary shall be lia15 ble under paragraph (1) for the performance of, or

16 the failure to perform, any non-medically reviewable

17 duty (as defined in paragraph (6)(B)(ii)) of the

18 plan, the plan sponsor, or any health insurance

19 issuer offering health insurance coverage in connec20 tion with the plan.

21 ‘‘(8) RULE OF CONSTRUCTION RELATING TO

22 EXCLUSION FROM LIABILITY OF PHYSICIANS,

23 HEALTH CARE PROFESSIONALS, AND HOSPITALS.—

24 Nothing in paragraph (6) or (7) shall be construed

25 to limit the liability (whether direct or vicarious) of
150

•S 1052 IS

1 the plan, the plan sponsor, or any health insurance

2 issuer offering health insurance coverage in connec3 tion with the plan.

4 ‘‘(9) REQUIREMENT OF EXHAUSTION.—

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

6 this paragraph, a cause of action may not be

7 brought under paragraph (1) in connection with

8 any denial of a claim for benefits of any indi9 vidual until all administrative processes under

10 sections 102 and 103 of the Bipartisan Patient

11 Protection Act of 2001 (if applicable) have been

12 exhausted.

13 ‘‘(B) LATE MANIFESTATION OF INJURY.—

14 The requirements under subparagraph (A) for a

15 cause of action in connection with any denial of

16 a claim for benefits shall be deemed satisfied,

17 notwithstanding any failure to timely commence

18 review under section 103 with respect to the de19 nial, if the personal injury is first known (or

20 first reasonably should have been known) to the

21 individual (or the death occurs) after the latest

22 date by which the applicable requirements of

23 subparagraph (A) can be met in connection

24 with such denial.
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•S 1052 IS

1 ‘‘(C) OCCURRENCE OF IMMEDIATE AND IR2 REPARABLE HARM OR DEATH PRIOR TO COM3 PLETION OF PROCESS.—

4 ‘‘(i) IN GENERAL.—The requirements

5 of subparagraph (A) shall not apply in any

6 case of immediate and irreparable harm or

7 death occurring, as a result of the denial

8 of a claim for benefits, prior to the comple9 tion of the administrative processes re10 ferred to in subparagraph (A) with respect

11 to such denial.

12 ‘‘(ii) CONSTRUCTION.—Nothing in

13 clause (i) shall be construed to preclude—

14 ‘‘(I) continuation of such proc15 esses to their conclusion if so moved

16 by any party, and

17 ‘‘(II) consideration in such action

18 of the final decisions issued in such

19 processes.

20 ‘‘(iii) DEFINITION.—In clause (i), the

21 term ‘irreparable harm’, with respect to an

22 individual, means an injury or condition

23 that, regardless of whether the individual

24 receives the treatment that is the subject

25 of the denial, cannot be repaired in a man-
152

•S 1052 IS

1 ner that would restore the individual to the

2 individual’s pre-injured condition.

3 ‘‘(D) RECEIPT OF BENEFITS DURING AP4 PEALS PROCESS.—Receipt by the participant or

5 beneficiary of the benefits involved in the claim

6 for benefits during the pendency of any admin7 istrative processes referred to in subparagraph

8 (A) or of any action commenced under this

9 subsection—

10 ‘‘(i) shall not preclude continuation of

11 all such administrative processes to their

12 conclusion if so moved by any party, and

13 ‘‘(ii) shall not preclude any liability

14 under subsection (a)(1)(C) and this sub15 section in connection with such claim.

16 The court in any action commenced under this

17 subsection shall take into account any receipt of

18 benefits during such administrative processes or

19 such action in determining the amount of the

20 damages awarded.

21 ‘‘(10) STATUTORY DAMAGES.—

22 ‘‘(A) IN GENERAL.—The remedies set

23 forth in this subsection (n) shall be the exclu24 sive remedies for causes of action brought

25 under this subsection.
153

•S 1052 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 OF ACTION.—Paragraph (1)

16 shall not apply in connection with any action com17 menced after 3 years after the later of—

18 ‘‘(A) the date on which the plaintiff first

19 knew, or reasonably should have known, of the

20 personal injury or death resulting from the fail21 ure described in paragraph (1), or

22 ‘‘(B) the date as of which the requirements

23 of paragraph (5) are first met.

24 ‘‘(12) TOLLING PROVISION.—The statute of

25 limitations for any cause of action arising under
154

•S 1052 IS

1 State law relating to a denial of a claim for benefits

2 that is the subject of an action brought in Federal

3 court under this subsection shall be tolled until such

4 time as the Federal court makes a final disposition,

5 including all appeals, of whether such claim should

6 properly be within the jurisdiction of the Federal

7 court. The tolling period shall be determined by the

8 applicable Federal or State law, whichever period is

9 greater.

10 ‘‘(13) PURCHASE OF INSURANCE TO COVER LI11 ABILITY.—Nothing in section 410 shall be construed

12 to preclude the purchase by a group health plan of

13 insurance to cover any liability or losses arising

14 under a cause of action under subsection (a)(1)(C)

15 and this subsection.

16 ‘‘(14) EXCLUSION OF DIRECTED RECORD17 KEEPERS.—

18 ‘‘(A) IN GENERAL.—Subject to subpara19 graph (C), paragraph (1) shall not apply with

20 respect to a directed recordkeeper in connection

21 with a group health plan.

22 ‘‘(B) DIRECTED RECORDKEEPER.—For

23 purposes of this paragraph, the term ‘directed

24 recordkeeper’ means, in connection with a

25 group health plan, a person engaged in directed
155

•S 1052 IS

1 recordkeeping activities pursuant to the specific

2 instructions of the plan or the employer or

3 other plan sponsor, including the distribution of

4 enrollment information and distribution of dis5 closure materials under this Act or title I of the

6 Bipartisan Patient Protection Act of 2001 and

7 whose duties do not include making decisions

8 on claims for benefits.

9 ‘‘(C) LIMITATION.—Subparagraph (A)

10 does not apply in connection with any directed

11 recordkeeper to the extent that the directed rec12 ordkeeper fails to follow the specific instruction

13 of the plan or the employer or other plan spon14 sor.

15 ‘‘(15) EXCLUSION OF HEALTH INSURANCE

16 AGENTS.—Paragraph (1) does not apply with re17 spect to a person whose sole involvement with the

18 group health plan is providing advice or administra19 tive services to the employer or other plan sponsor

20 relating to the selection of health insurance coverage

21 offered in connection with the plan.

22 ‘‘(16) NO EFFECT ON STATE LAW.—No provi23 sion of State law (as defined in section 514(c)(1))

24 shall be treated as superseded or otherwise altered,

25 amended, modified, invalidated, or impaired by rea-
156

•S 1052 IS

1 son of the provisions of subsection (a)(1)(C) and this

2 subsection.’’.

3 (2) CONFORMING AMENDMENT.—Section

4 502(a)(1) of such Act (29 U.S.C. 1132(a)(1)) is

5 amended—

6 (A) by striking ‘‘or’’ at the end of subpara7 graph (A);

8 (B) in subparagraph (B), by striking

9 ‘‘plan;’’ and inserting ‘‘plan, or’’; and

10 (C) by adding at the end the following new

11 subparagraph:

12 ‘‘(C) for the relief provided for in sub13 section (n) of this section.’’.

14 (b) RULES RELATING TO ERISA PREEMPTION.—

15 Section 514 of the Employee Retirement Income Security

16 Act of 1974 (29 U.S.C. 1144) is amended—

17 (1) by redesignating subsection (d) as sub18 section (f); and

19 (2) by inserting after subsection (c) the fol20 lowing new subsections:

21 ‘‘(d) PREEMPTION NOT TO APPLY TO CAUSES OF

22 ACTION UNDER STATE LAW INVOLVING MEDICALLY RE23 VIEWABLE DECISION.—

24 ‘‘(1) NON-PREEMPTION OF CERTAIN CAUSES OF

25 ACTION.—
157

•S 1052 IS

1 ‘‘(A) IN GENERAL.—Except as provided in

2 this subsection, nothing in this title (including

3 section 502) shall be construed to supersede or

4 otherwise alter, amend, modify, invalidate, or

5 impair any cause of action under State law of

6 a participant or beneficiary under a group

7 health plan (or the estate of such a participant

8 or beneficiary) to recover damages resulting

9 from personal injury or for wrongful death

10 against any person if such cause of action

11 arises by reason of a medically reviewable deci12 sion.

13 ‘‘(B) MEDICALLY REVIEWABLE DECI14 SION.—For purposes of subparagraph (A), the

15 term ‘medically reviewable decision’ means a de16 nial of a claim for benefits under the plan

17 which is described in section 104(d)(2) of the

18 Bipartisan Patient Protection Act of 2001 (re19 lating to medically reviewable decisions).

20 ‘‘(C) LIMITATION ON PUNITIVE DAM21 AGES.—

22 ‘‘(i) IN GENERAL.—Except as pro23 vided in clauses (ii) and (iii), with respect

24 to a cause of action described in subpara25 graph (A) brought with respect to a partic-
158

•S 1052 IS

1 ipant or beneficiary, State law is super2 seded insofar as it provides any punitive,

3 exemplary, or similar damages if, as of the

4 time of the personal injury or death, all

5 the requirements of the following sections

6 of the Bipartisan Patient Protection Act of

7 2001 were satisfied with respect to the

8 participant or beneficiary:

9 ‘‘(I) Section 102 (relating to pro10 cedures for initial claims for benefits

11 and prior authorization determina12 tions).

13 ‘‘(II) Section 103 of such Act

14 (relating to internal appeals of claims

15 denials).

16 ‘‘(III) Section 104 of such Act

17 (relating to independent external ap18 peals procedures).

19 ‘‘(ii) EXCEPTION FOR CERTAIN AC20 TIONS FOR WRONGFUL DEATH.—Clause (i)

21 shall not apply with respect to an action

22 for wrongful death if the applicable State

23 law provides (or has been construed to pro24 vide) for damages in such an action which

25 are only punitive or exemplary in nature.
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•S 1052 IS

1 ‘‘(iii) EXCEPTION FOR WILLFUL OR

2 WANTON DISREGARD FOR THE RIGHTS OR

3 SAFETY OF OTHERS.—Clause (i) shall not

4 apply with respect to any cause of action

5 described in subparagraph (A) if, in such

6 action, the plaintiff establishes by clear

7 and convincing evidence that conduct car8 ried out by the defendant with willful or

9 wanton disregard for the rights or safety

10 of others was a proximate cause of the per11 sonal injury or wrongful death that is the

12 subject of the action.

13 ‘‘(2) DEFINITIONS.—For purposes of this sub14 section and subsection (e)—

15 ‘‘(A) GROUP HEALTH PLAN AND OTHER

16 RELATED TERMS.—The provisions of sections

17 732(d) and 733 apply for purposes of this sub18 section in the same manner as they apply for

19 purposes of part 7, except that the term ‘group

20 health plan’ includes a group health plan (as

21 defined in section 607(1)).

22 ‘‘(B) PERSONAL INJURY.—The term ‘per23 sonal injury’ means a physical injury and in24 cludes an injury arising out of the treatment

25 (or failure to treat) a mental illness or disease.
160

•S 1052 IS

1 ‘‘(C) CLAIM FOR BENEFIT; DENIAL.—The

2 terms ‘claim for benefits’ and ‘denial of a claim

3 for benefits’ shall have the meaning provided

4 such terms under section 102(e) of the Bipar5 tisan Patient Protection Act of 2001.

6 ‘‘(3) EXCLUSION OF EMPLOYERS AND OTHER

7 PLAN SPONSORS.—

8 ‘‘(A) CAUSES OF ACTION AGAINST EM9 PLOYERS AND PLAN SPONSORS PRECLUDED.—

10 Subject to subparagraph (B), paragraph (1)

11 does not apply with respect to—

12 ‘‘(i) any cause of action against an

13 employer or other plan sponsor maintain14 ing the plan (or against an employee of

15 such an employer or sponsor acting within

16 the scope of employment), or

17 ‘‘(ii) a right of recovery, indemnity, or

18 contribution by a person against an em19 ployer or other plan sponsor (or such an

20 employee) for damages assessed against

21 the person pursuant to a cause of action to

22 which paragraph (1) applies.

23 ‘‘(B) CERTAIN CAUSES OF ACTION PER24 MITTED.—Notwithstanding subparagraph (A),

25 paragraph (1) applies with respect to any cause
161

•S 1052 IS

1 of action described in paragraph (1) maintained

2 by a participant or beneficiary against an em3 ployer or other plan sponsor (or against an em4 ployee of such an employer or sponsor acting

5 within the scope of employment)—

6 ‘‘(i) in the case of any cause of action

7 based on a decision of the plan under sec8 tion 102 of the Bipartisan Patient Protec9 tion Act of 2001 upon consideration of a

10 claim for benefits or under section 103 of

11 such Act upon review of a denial of a claim

12 for benefits, to the extent there was direct

13 participation by the employer or other plan

14 sponsor (or employee) in the decision, or

15 ‘‘(ii) in the case of any cause of action

16 based on a failure to otherwise perform a

17 duty under the terms and conditions of the

18 plan with respect to a claim for benefits of

19 a participant or beneficiary, to the extent

20 there was direct participation by the em21 ployer or other plan sponsor (or employee)

22 in the failure.

23 ‘‘(C) DIRECT PARTICIPATION.—

24 ‘‘(i) DIRECT PARTICIPATION IN DECI25 SIONS.—For purposes of subparagraph
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1 (B), the term ‘direct participation’ means,

2 in connection with a decision described in

3 subparagraph (B)(i) or a failure described

4 in subparagraph (B)(ii), the actual making

5 of such decision or the actual exercise of

6 control in making such decision or in the

7 conduct constituting the failure.

8 ‘‘(ii) RULES OF CONSTRUCTION.—For

9 purposes of clause (i), the employer or plan

10 sponsor (or employee) shall not be con11 strued to be engaged in direct participation

12 because of any form of decisionmaking or

13 other conduct that is merely collateral or

14 precedent to the decision described in sub15 paragraph (B)(i) on a particular claim for

16 benefits of a particular participant or bene17 ficiary or that is merely collateral or prece18 dent to the conduct constituting a failure

19 described in subparagraph (B)(ii) with re20 spect to a particular participant or bene21 ficiary, including (but not limited to)—

22 ‘‘(I) any participation by the em23 ployer or other plan sponsor (or em24 ployee) in the selection of the group

25 health plan or health insurance cov-
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1 erage involved or the third party ad2 ministrator or other agent;

3 ‘‘(II) any engagement by the em4 ployer or other plan sponsor (or em5 ployee) in any cost-benefit analysis

6 undertaken in connection with the se7 lection of, or continued maintenance

8 of, the plan or coverage involved;

9 ‘‘(III) any participation by the

10 employer or other plan sponsor (or

11 employee) in the process of creating,

12 continuing, modifying, or terminating

13 the plan or any benefit under the

14 plan, if such process was not substan15 tially focused solely on the particular

16 situation of the participant or bene17 ficiary referred to in paragraph

18 (1)(A); and

19 ‘‘(IV) any participation by the

20 employer or other plan sponsor (or

21 employee) in the design of any benefit

22 under the plan, including the amount

23 of copayment and limits connected

24 with such benefit.
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1 ‘‘(iv) IRRELEVANCE OF CERTAIN COL2 LATERAL EFFORTS MADE BY EMPLOYER

3 OR PLAN SPONSOR.—For purposes of this

4 subparagraph, an employer or plan sponsor

5 shall not be treated as engaged in direct

6 participation in a decision with respect to

7 any claim for benefits or denial thereof in

8 the case of any particular participant or

9 beneficiary solely by reason of—

10 ‘‘(I) any efforts that may have

11 been made by the employer or plan

12 sponsor to advocate for authorization

13 of coverage for that or any other par14 ticipant or beneficiary (or any group

15 of participants or beneficiaries), or

16 ‘‘(II) any provision that may

17 have been made by the employer or

18 plan sponsor for benefits which are

19 not covered under the terms and con20 ditions of the plan for that or any

21 other participant or beneficiary (or

22 any group of participants or bene23 ficiaries).

24 ‘‘(4) REQUIREMENT OF EXHAUSTION.—
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1 ‘‘(A) IN GENERAL.—Except as provided in

2 this paragraph, paragraph (1) shall not apply

3 with respect to a cause of action described in

4 such paragraph in connection with any denial of

5 a claim for benefits of any individual until all

6 administrative processes under sections 102,

7 103, and 104 of the Bipartisan Patient Protec8 tion Act of 2001 (if applicable) have been ex9 hausted.

10 ‘‘(B) LATE MANIFESTATION OF INJURY.—

11 The requirements under subparagraph (A) for a

12 cause of action in connection with any denial of

13 a claim for benefits shall be deemed satisfied,

14 notwithstanding any failure to timely commence

15 review under section 103 or 104 with respect to

16 the denial, if the personal injury is first known

17 (or first should have been known) to the indi18 vidual (or the death occurs) after the latest

19 date by which the applicable requirements of

20 subparagraph (A) can be met in connection

21 with such denial.

22 ‘‘(C) OCCURRENCE OF IMMEDIATE AN IR23 REPARABLE HARM OR DEATH PRIOR TO COM24 PLETION OF PROCESS.—
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1 ‘‘(i) IN GENERAL.—The requirements

2 of subparagraph (A) shall not apply in any

3 case of immediate and irreparable harm or

4 death occurring, as a result of the denial

5 of a claim for benefits, prior to the comple6 tion of the administrative processes re7 ferred to in subparagraph (A) with respect

8 to such denial.

9 ‘‘(ii) CONSTRUCTION.—Nothing in

10 clause (i) shall be construed to preclude—

11 ‘‘(I) continuation of such proc12 esses to their conclusion if so moved

13 by any party, and

14 ‘‘(II) consideration in such action

15 of the final decisions issued in such

16 processes.

17 ‘‘(iii) DEFINITION.—In clause (i), the

18 term ‘irreparable harm’, with respect to an

19 individual, means an injury or condition

20 that, regardless of whether the individual

21 receives the treatment that is the subject

22 of the denial, cannot be repaired in a man23 ner that would restore the individual to the

24 individual’s pre-injured condition.
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•S 1052 IS

1 ‘‘(D) RECEIPT OF BENEFITS DURING AP2 PEALS PROCESS.—Receipt by the participant or

3 beneficiary of the benefits involved in the claim

4 for benefits during the pendency of any admin5 istrative processes referred to in subparagraph

6 (A) or of any action commenced under this

7 subsection—

8 ‘‘(i) shall not preclude continuation of

9 all such administrative processes to their

10 conclusion if so moved by any party, and

11 ‘‘(ii) shall not preclude any liability

12 under subsection (a)(1)(C) and this sub13 section in connection with such claim.

14 ‘‘(5) TOLLING PROVISION.—The statute of limi15 tations for any cause of action arising under section

16 502(n) relating to a denial of a claim for benefits

17 that is the subject of an action brought in State

18 court shall be tolled until such time as the State

19 court makes a final disposition, including all ap20 peals, of whether such claim should properly be

21 within the jurisdiction of the State court. The tolling

22 period shall be determined by the applicable Federal

23 or State law, whichever period is greater.

24 ‘‘(6) EXCLUSION OF DIRECTED RECORD25 KEEPERS.—
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1 ‘‘(A) IN GENERAL.—Subject to subpara2 graph (C), paragraph (1) shall not apply with

3 respect to a directed recordkeeper in connection

4 with a group health plan.

5 ‘‘(B) DIRECTED RECORDKEEPER.—For

6 purposes of this paragraph, the term ‘directed

7 recordkeeper’ means, in connection with a

8 group health plan, a person engaged in directed

9 recordkeeping activities pursuant to the specific

10 instructions of the plan or the employer or

11 other plan sponsor, including the distribution of

12 enrollment information and distribution of dis13 closure materials under this Act or title I of the

14 Bipartisan Patient Protection Act of 2001 and

15 whose duties do not include making decisions

16 on claims for benefits.

17 ‘‘(C) LIMITATION.—Subparagraph (A)

18 does not apply in connection with any directed

19 recordkeeper to the extent that the directed rec20 ordkeeper fails to follow the specific instruction

21 of the plan or the employer or other plan spon22 sor.

23 ‘‘(7) CONSTRUCTION.—Nothing in this sub24 section shall be construed as—
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•S 1052 IS

1 ‘‘(A) saving from preemption a cause of

2 action under State law for the failure to provide

3 a benefit for an item or service which is specifi4 cally excluded under the group health plan in5 volved, except to the extent that—

6 ‘‘(i) the application or interpretation

7 of the exclusion involves a determination

8 described in section 104(d)(2) of the Bi9 partisan Patient Protection Act of 2001,

10 or

11 ‘‘(ii) the provision of the benefit for

12 the item or service is required under Fed13 eral law or under applicable State law con14 sistent with subsection (b)(2)(B);

15 ‘‘(B) preempting a State law which re16 quires an affidavit or certificate of merit in a

17 civil action;

18 ‘‘(C) affecting a cause of action or remedy

19 under State law in connection with the provi20 sion or arrangement of excepted benefits (as de21 fined in section 733(c)), other than those de22 scribed in section 733(c)(2)(A); or

23 ‘‘(D) affecting a cause of action under

24 State law other than a cause of action described

25 in paragraph (1)(A).
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1 ‘‘(8) PURCHASE OF INSURANCE TO COVER LI2 ABILITY.—Nothing in section 410 shall be construed

3 to preclude the purchase by a group health plan of

4 insurance to cover any liability or losses arising

5 under a cause of action described in paragraph

6 (1)(A).

7 ‘‘(e) RULES OF CONSTRUCTION RELATING TO

8 HEALTH CARE.—Nothing in this title shall be construed

9 as—

10 ‘‘(1) affecting any State law relating to the

11 practice of medicine or the provision of, or the fail12 ure to provide, medical care, or affecting any action

13 (whether the liability is direct or vicarious) based

14 upon such a State law,

15 ‘‘(2) superseding any State law permitted under

16 section 152(b)(1)(A) of the Bipartisan Patient Pro17 tection Act of 2001, or

18 ‘‘(3) affecting any applicable State law with re19 spect to limitations on monetary damages.’’.

20 (c) EFFECTIVE DATE.—The amendments made by

21 this section shall apply to acts and omissions (from which

22 a cause of action arises) occurring on or after October 1,

23 2002.
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1 SEC. 303. LIMITATIONS ON ACTIONS.

2 Section 502 of the Employee Retirement Income Se3 curity Act of 1974 (29 U.S.C. 1132) (as amended by sec4 tion 302(a)) is amended further by adding at the end the

5 following new subsection:

6 ‘‘(o) LIMITATIONS ON ACTIONS RELATING TO GROUP

7 HEALTH PLANS.—

8 ‘‘(1) IN GENERAL.—Except as provided in para9 graph (2), no action may be brought under sub10 section (a)(1)(B), (a)(2), or (a)(3) by a participant

11 or beneficiary seeking relief based on the application

12 of any provision in section 101, subtitle B, or sub13 title D of title I of the Bipartisan Patient Protection

14 Act (as incorporated under section 714).

15 ‘‘(2) CERTAIN ACTIONS ALLOWABLE.—An ac16 tion may be brought under subsection (a)(1)(B),

17 (a)(2), or (a)(3) by a participant or beneficiary seek18 ing relief based on the application of section 101,

19 113, 114, 115, 116, 117, 118(a)(3), 119, or 120 of

20 the Bipartisan Patient Protection Act (as incor21 porated under section 714) to the individual cir22 cumstances of that participant or beneficiary, except

23 that—

24 ‘‘(A) such an action may not be brought or

25 maintained as a class action; and
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•S 1052 IS

1 ‘‘(B) in such an action, relief may only

2 provide for the provision of (or payment of)

3 benefits, items, or services denied to the indi4 vidual participant or beneficiary involved (and

5 for attorney’s fees and the costs of the action,

6 at the discretion of the court) and shall not pro7 vide for any other relief to the participant or

8 beneficiary or for any relief to any other person.

9 ‘‘(3) OTHER PROVISIONS UNAFFECTED.—Noth10 ing in this subsection shall be construed as affecting

11 subsections (a)(1)(C) and (n) or section 514(d).

12 ‘‘(4) ENFORCEMENT BY SECRETARY UNAF13 FECTED.—Nothing in this subsection shall be con14 strued as affecting any action brought by the Sec15 retary.’’.

16 TITLE IV—EFFECTIVE DATES;

17 COORDINATION IN IMPLE18 MENTATION

19 SEC. 401. EFFECTIVE DATES.

20 (a) GROUP HEALTH COVERAGE.—

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

22 and subsection (d), the amendments made by sec23 tions 201(a), 301, and 303 (and title I insofar as it

24 relates to such sections) shall apply with respect to

25 group health plans, and health insurance coverage
173

•S 1052 IS

1 offered in connection with group health plans, for

2 plan years beginning on or after October 1, 2002 (in

3 this section referred to as the ‘‘general effective

4 date’’).

5 (2) TREATMENT OF COLLECTIVE BARGAINING

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

7 maintained pursuant to one or more collective bar8 gaining agreements between employee representa9 tives and one or more employers ratified before the

10 date of the enactment of this Act, the amendments

11 made by sections 201(a), 301, and 303 (and title I

12 insofar as it relates to such sections) shall not apply

13 to plan years beginning before the later of—

14 (A) the date on which the last collective

15 bargaining agreements relating to the plan ter16 minates (determined without regard to any ex17 tension thereof agreed to after the date of the

18 enactment of this Act); or

19 (B) the general effective date.

20 For purposes of subparagraph (A), any plan amend21 ment made pursuant to a collective bargaining

22 agreement relating to the plan which amends the

23 plan solely to conform to any requirement added by

24 this Act shall not be treated as a termination of

25 such collective bargaining agreement.
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•S 1052 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
175

•S 1052 IS

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
176

•S 1052 IS

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. 402. 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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•S 1052 IS

1 SEC. 403. 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 V—MISCELLANEOUS

10 PROVISIONS

11 SEC. 501. 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. 502. 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 ‘‘2003’’ and inserting ‘‘2011, ex12 cept that fees may not be charged under paragraphs (9)

13 and (10) of such subsection after March 31, 2006’’.

14 SEC. 503. FISCAL YEAR 2002 MEDICARE PAYMENTS.

15 Notwithstanding any other provision of law, any let16 ter of credit under part B of title XVIII of the Social Se17 curity Act (42 U.S.C. 1395j et seq.) that would otherwise

18 be sent to the Treasury or the Federal Reserve Board on

19 September 30, 2002, by a carrier with a contract under

20 section 1842 of that Act (42 U.S.C. 1395u) shall be sent

21 on October 1, 2002.

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