Calendar No. 160

106TH CONGRESS

1ST SESSION S. 326

[Report No. 106–82]

A BILL

To improve the access and choice of patients to

quality, affordable health care.

JUNE 17, 1999

Reported with an amendment
II

Calendar No. 160

106TH CONGRESS

1ST SESSION S. 326

[Report No. 106–82]

To improve the access and choice of patients to quality, affordable health

care.

IN THE SENATE OF THE UNITED STATES

JANUARY 28, 1999

Mr. JEFFORDS (for himself, Mr. FRIST, Mr. DEWINE, Mr. ENZI, Mr. HUTCHINSON, Ms. COLLINS, Mr. BROWNBACK, Mr. HAGEL, Mr. SESSIONS, Mr.

BURNS, and Mr. GREGG) introduced the following bill; which was read

twice and referred to the Committee on Health, Education, Labor, and

Pensions

JUNE 17, 1999

[Strike out all after the enacting clause and insert the part printed in italic]

A BILL

To improve the access and choice of patients to quality,

affordable health care.

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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

5 ‘‘Patients’ Bill of Rights Act’’.
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1 (b) TABLE OF CONTENTS.—The table of contents for

2 this Act is as follows:

Sec. 1. Short title; table of contents.

TITLE I—PATIENTS’ BILL OF RIGHTS

Subtitle A—Right to Advice and Care

Sec. 101. Patient right to medical advice and care.

‘‘SUBPART C—PATIENT RIGHT TO MEDICAL ADVICE AND CARE

‘‘Sec. 721. Patient access to emergency medical care.

‘‘Sec. 722. Offering of choice of coverage options.

‘‘Sec. 723. Patient access to obstetric and gynecological care.

‘‘Sec. 724. Patient access to pediatric care.

‘‘Sec. 725. Continuity of care.

‘‘Sec. 726. Protection of patient-provider communications.

‘‘Sec. 727. Generally applicable provision.’’

Sec. 102. Effective date and related rules.

Subtitle B—Right to Information About Plans and Providers

Sec. 111. Information about plans.

Sec. 112. Information about providers.

Subtitle C—Right to Hold Health Plans Accountable

Sec. 121. Amendment to Employee Retirement Income Security Act of 1974.

TITLE II—INDIVIDUAL RIGHTS WITH RESPECT TO PERSONAL

MEDICAL INFORMATION

Sec. 201. Short title.

Subtitle A—Access to Medical Records

Sec. 211. Inspection and copying of protected health information.

Sec. 212. Amendment of protected health information.

Sec. 213. Notice of confidentiality practices.

Subtitle B—Establishment of Safeguards

Sec. 221. Establishment of safeguards.

Subtitle C—Enforcement; Definitions

Sec. 231. Civil penalty.

Sec. 232. Definitions.

Sec. 233. Effective date.

TITLE III—GENETIC INFORMATION AND SERVICES

Sec. 301. Short title.

Sec. 302. Amendments to Employee Retirement Income Security Act of 1974.

Sec. 303. Amendments to the Public Health Service Act.

TITLE IV—HEALTHCARE RESEARCH AND QUALITY
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Sec. 401. Short title.

Sec. 402. Amendment to the Public Health Service Act.

‘‘TITLE IX—AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

‘‘PART A—ESTABLISHMENT AND GENERAL DUTIES

‘‘Sec. 901. Mission and duties.

‘‘Sec. 902. General authorities.

‘‘PART B—HEALTHCARE IMPROVEMENT RESEARCH

‘‘Sec. 911. Healthcare outcome improvement research.

‘‘Sec. 912. Private-public partnerships to improve organization and delivery.

‘‘Sec. 913. Information on quality and cost of care.

‘‘Sec. 914. Information systems for healthcare improvement.

‘‘Sec. 915. Research supporting primary care and access in underserved

areas.

‘‘Sec. 916. Clinical practice and technology innovation.

‘‘Sec. 917. Coordination of Federal Government quality improvement efforts.

‘‘PART C—GENERAL PROVISIONS

‘‘Sec. 921. Advisory Council for Healthcare Research and Quality.

‘‘Sec. 922. Peer review with respect to grants and contracts.

‘‘Sec. 923. Certain provisions with respect to development, collection, and

dissemination of data.

‘‘Sec. 924. Dissemination of information.

‘‘Sec. 925. Additional provisions with respect to grants and contracts.

‘‘Sec. 926. Certain administrative authorities.

‘‘Sec. 927. Funding.

‘‘Sec. 928. Definitions.’’

Sec. 403. References.

Sec. 404. Study.

TITLE V—MISCELLANEOUS PROVISIONS

Sec. 501. Sense of the Committee.

1 TITLE I—PATIENTS’ BILL OF

2 RIGHTS

3 Subtitle A—Right to Advice and

4 Care

5 SEC. 101. PATIENT RIGHT TO MEDICAL ADVICE AND CARE.

6 (a) IN GENERAL.—Part 7 of subtitle B of title I of

7 the Employee Retirement Income Security Act of 1974

8 (29 U.S.C. 1185 et seq.) is amended—
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1 (1) by redesignating subpart C as subpart D;

2 and

3 (2) by inserting after subpart B the following:

4 ‘‘Subpart C—Patient Right to Medical Advice and

5 Care

6 ‘‘SEC. 721. PATIENT ACCESS TO EMERGENCY MEDICAL

7 CARE.

8 ‘‘(a) IN GENERAL.—To the extent that the group

9 health plan (other than a fully insured group health plan)

10 provides coverage for benefits consisting of emergency

11 medical care (as defined in subsection (c)), except for

12 items or services specifically excluded—

13 ‘‘(1) the plan shall provide coverage for bene14 fits, without requiring preauthorization, for appro15 priate emergency medical screening examinations

16 (within the capability of the emergency facility, in17 cluding ancillary services routinely available to the

18 emergency facility) to the extent that a prudent

19 layperson, who possesses an average knowledge of

20 health and medicine, would determine such examina21 tions to be necessary to determine whether emer22 gency medical care (as so defined) is necessary, and

23 ‘‘(2) the plan shall provide coverage for benefits

24 for additional emergency medical care to stabilize an

25 emergency medical condition following an emergency
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1 medical screening examination (if determined nec2 essary under paragraph (1)), pursuant to the defini3 tion of stabilize under section 1867(e)(3) of the So4 cial Security Act (42 U.S.C. 1395dd(e)(3)).

5 ‘‘(b) UNIFORM COST-SHARING REQUIRED.—Nothing

6 in this section shall be construed as preventing a group

7 health plan (other than a fully insured group health plan)

8 from imposing any form of cost-sharing applicable to any

9 participant or beneficiary (including coinsurance, copay10 ments, deductibles, and any other charges) in relation to

11 coverage for benefits described in subsection (a), if such

12 form of cost-sharing is uniformly applied under such plan,

13 with respect to similarly situated participants and bene14 ficiaries, to all benefits consisting of emergency medical

15 care (as defined in subsection (c)) provided to such simi16 larly situated participants and beneficiaries under the

17 plan.

18 ‘‘(c) DEFINITION OF EMERGENCY MEDICAL CARE.—

19 In this section:

20 ‘‘(1) IN GENERAL.—The term ‘‘emergency med21 ical care’’ means, with respect to a participant or

22 beneficiary under a group health plan (other than a

23 fully insured group health plan), covered inpatient

24 and outpatient services that—
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1 ‘‘(A) are furnished by any provider, includ2 ing a nonparticipating provider, that is qualified

3 to furnish such services; and

4 ‘‘(B) are needed to evaluate or stabilize (as

5 such term is defined in section 1867(e)(3) of

6 the Social Security Act (42 U.S.C. 1395dd)) an

7 emergency medical condition (as defined in

8 paragraph (2)).

9 ‘‘(2) EMERGENCY MEDICAL CONDITION.—The

10 term ‘‘emergency medical condition’’ means a med11 ical condition manifesting itself by acute symptoms

12 of sufficient severity (including severe pain) such

13 that a prudent layperson, who possesses an average

14 knowledge of health and medicine, could reasonably

15 expect the absence of immediate medical attention to

16 result in—

17 ‘‘(A) placing the health of the participant

18 or beneficiary (or, with respect to a pregnant

19 woman, the health of the woman or her unborn

20 child) in serious jeopardy,

21 ‘‘(B) serious impairment to bodily func22 tions, or

23 ‘‘(C) serious dysfunction of any bodily

24 organ or part.
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1 ‘‘SEC. 722. OFFERING OF CHOICE OF COVERAGE OPTIONS.

2 ‘‘(a) REQUIREMENT.—

3 ‘‘(1) OFFERING OF POINT-OF-SERVICE COV4 ERAGE OPTION.—Except as provided in paragraph

5 (2), if a group health plan (other than a fully in6 sured group health plan) provides coverage for bene7 fits only through a defined set of participating

8 health care professionals, the plan shall offer the

9 participant the option to purchase point-of-service

10 coverage (as defined in subsection (b)) for all such

11 benefits for which coverage is otherwise so limited.

12 Such option shall be made available to the partici13 pant at the time of enrollment under the plan and

14 at such other times as the plan offers the participant

15 a choice of coverage options.

16 ‘‘(2) EXCEPTION IN THE CASE OF MULTIPLE

17 ISSUER OR COVERAGE OPTIONS.—Paragraph (1)

18 shall not apply with respect to a participant in a

19 group health plan (other than a fully insured group

20 health plan) if the plan offers the participant—

21 ‘‘(A) a choice of health insurance coverage

22 through more than one health insurance issuer;

23 or

24 ‘‘(B) two or more coverage options that

25 differ significantly with respect to the use of
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1 participating health care professionals or the

2 networks of such professionals that are used.

3 ‘‘(b) POINT-OF-SERVICE COVERAGE DEFINED.—In

4 this section, the term ‘point-of-service coverage’ means,

5 with respect to benefits covered under a group health plan

6 (other than a fully insured group health plan), coverage

7 of such benefits when provided by a nonparticipating

8 health care professional.

9 ‘‘(c) SMALL EMPLOYER EXEMPTION.—

10 ‘‘(1) IN GENERAL.—This section shall not apply

11 to any group health plan (other than a fully insured

12 group health plan) of a small employer.

13 ‘‘(2) SMALL EMPLOYER.—For purposes of

14 paragraph (1), the term ‘small employer’ means, in

15 connection with a group health plan (other than a

16 fully insured group health plan) with respect to a

17 calendar year and a plan year, an employer who em18 ployed an average of at least 2 but not more than

19 50 employees on business days during the preceding

20 calendar year and who employs at least 2 employees

21 on the first day of the plan year. For purposes of

22 this paragraph, the provisions of subparagraph (C)

23 of section 712(c)(1) shall apply in determining em24 ployer size.
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1 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec2 tion shall be construed—

3 ‘‘(1) as requiring coverage for benefits for a

4 particular type of health care professional;

5 ‘‘(2) as requiring an employer to pay any costs

6 as a result of this section or to make equal contribu7 tions with respect to different health coverage op8 tions;

9 ‘‘(3) as preventing a group health plan (other

10 than a fully insured group health plan) from impos11 ing higher premiums or cost-sharing on a partici12 pant for the exercise of a point-of-service coverage

13 option; or

14 ‘‘(4) to require that a group health plan (other

15 than a fully insured group health plan) include cov16 erage of health care professionals that the plan ex17 cludes because of fraud, quality of care, or other

18 similar reasons with respect to such professionals.

19 ‘‘SEC. 723. PATIENT ACCESS TO OBSTETRIC AND GYNECO20 LOGICAL CARE.

21 ‘‘(a) IN GENERAL.—In any case in which a group

22 health plan (other than a fully insured group health

23 plan)—

24 ‘‘(1) provides coverage for benefits consisting

25 of—
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1 ‘‘(A) gynecological care (such as preventive

2 women’s health examinations); or

3 ‘‘(B) obstetric care (such as pregnancy-re4 lated services);

5 provided by a participating physician who specializes

6 in such care; and

7 ‘‘(2) requires or provides for designation by a

8 participant or beneficiary of a participating primary

9 care provider;

10 if the primary care provider designated by such a partici11 pant or beneficiary is not such a physician as described

12 in paragraph (1), then the plan shall meet the require13 ments of subsection (b).

14 ‘‘(b) REQUIREMENTS.—A group health plan (other

15 than a fully insured group health plan) meets the require16 ments of this subsection, in connection with the coverage

17 of benefits described in subsection (a) consisting of care

18 described in subparagraph (A) or (B) of subsection (a)(1),

19 if the plan—

20 ‘‘(1) does not require authorization or a referral

21 by the primary care provider in order to obtain cov22 erage for such benefits, and

23 ‘‘(2) treats the ordering of other routine care

24 related to the care described in subparagraph (A) or

25 (B) of subsection (a)(1), by the participating physi-
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1 cian providing the care described in either such sub2 paragraph, as the authorization of the primary care

3 provider with respect to such care.

4 ‘‘(c) RULE OF CONSTRUCTION.—Nothing in sub5 section (b)(2) shall waive any requirements of coverage re6 lating to medical necessity or appropriateness with respect

7 to coverage of gynecological or obstetric care so ordered.

8 Nothing in subsection (b) shall be construed to preclude

9 the health plan from requiring that the obstetrician or

10 gynecologist notify the primary care provider or the plan

11 of treatment decisions.

12 ‘‘SEC. 724. PATIENT ACCESS TO PEDIATRIC CARE.

13 ‘‘(a) IN GENERAL.—In any case in which a group

14 health plan (other than a fully insured group health

15 plan)—

16 ‘‘(1) provides coverage for benefits consisting of

17 pediatric care by a participating pediatrician; and

18 ‘‘(2) requires or provides for designation by a

19 participant or beneficiary of a participating primary

20 care provider;

21 if the primary care provider designated by such a partici22 pant or beneficiary is not a physician as described in para23 graph (1), then the plan shall meet the requirements of

24 subsection (b).
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1 ‘‘(b) REQUIREMENTS.—A group health plan (other

2 than a fully insured group health plan) meets the require3 ments of this subsection, in connection with the coverage

4 of benefits described in subsection (a) consisting of care

5 described in subsection (a)(1), if the plan—

6 ‘‘(1) does not require authorization or a referral

7 by the primary care provider in order to obtain cov8 erage for such benefits, and

9 ‘‘(2) treats the ordering of other routine care of

10 the same type, by the participating physician pro11 viding the care described in subsection (a)(1), as the

12 authorization of the primary care provider with re13 spect to such care.

14 ‘‘(c) CONSTRUCTION.—Nothing in subsection (b)(2)

15 shall waive any requirements of coverage relating to med16 ical necessity or appropriateness with respect to coverage

17 of pediatric care so ordered.

18 ‘‘SEC. 725. CONTINUITY OF CARE.

19 ‘‘(a) IN GENERAL.—

20 ‘‘(1) TERMINATION OF PROVIDER.—If a con21 tract between a group health plan (other than a fully

22 insured group health plan) and a health care pro23 vider is terminated (as defined in paragraph (2)), or

24 benefits or coverage provided by a health care pro25 vider are terminated because of a change in the
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1 terms of provider participation in such group health

2 plan, and an individual who is a participant or bene3 ficiary in the plan is undergoing a course of treat4 ment from the provider at the time of such termi5 nation, the plan shall—

6 ‘‘(A) notify the individual on a timely basis

7 of such termination;

8 ‘‘(B) provide the individual with an oppor9 tunity to notify the plan of a need for transi10 tional care; and

11 ‘‘(C) in the case of termination described

12 in paragraph (2), (3), or (4) of subsection (b),

13 and subject to subsection (c), permit the indi14 vidual to continue or be covered with respect to

15 the course of treatment with the provider’s con16 sent during a transitional period (as provided

17 under subsection (b)).

18 ‘‘(2) TERMINATED.—In this section, the term

19 ‘terminated’ includes, with respect to a contract, the

20 expiration or nonrenewal of the contract by the

21 group health plan, but does not include a termi22 nation of the contract by the plan for failure to meet

23 applicable quality standards or for fraud.

24 ‘‘(3) CONTRACTS.—For purposes of this sec25 tion, the term ‘contract between a group health plan
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1 (other than a fully insured group health plan) and

2 a health care provider’ shall include a contract be3 tween such a plan and an organized network of pro4 viders.

5 ‘‘(b) TRANSITIONAL PERIOD.—

6 ‘‘(1) GENERAL RULE.—Except as provided in

7 paragraph (3), the transitional period under this

8 subsection shall extend for up to 90 days from the

9 date of the notice described in subsection (a)(1)(A)

10 of the provider’s termination.

11 ‘‘(2) INSTITUTIONAL CARE.—Subject to para12 graph (1), the transitional period under this sub13 section for institutional or inpatient care from a pro14 vider shall extend until the discharge or termination

15 of the period of institutionalization and also shall in16 clude institutional care provided within a reasonable

17 time of the date of termination of the provider sta18 tus if the care was scheduled before the date of the

19 announcement of the termination of the provider

20 status under subsection (a)(1)(A) or if the individual

21 on such date was on an established waiting list or

22 otherwise scheduled to have such care.

23 ‘‘(3) PREGNANCY.—Notwithstanding paragraph

24 (1), if—
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1 ‘‘(A) a participant or beneficiary has en2 tered the second trimester of pregnancy at the

3 time of a provider’s termination of participa4 tion; and

5 ‘‘(B) the provider was treating the preg6 nancy before the date of the termination;

7 the transitional period under this subsection with re8 spect to provider’s treatment of the pregnancy shall

9 extend through the provision of post-partum care di10 rectly related to the delivery.

11 ‘‘(4) TERMINAL ILLNESS.—Subject to para12 graph (1), if—

13 ‘‘(A) a participant or beneficiary was de14 termined to be terminally ill (as determined

15 under section 1861(dd)(3)(A) of the Social Se16 curity Act) prior to a provider’s termination of

17 participation; and

18 ‘‘(B) the provider was treating the ter19 minal illness before the date of termination;

20 the transitional period under this subsection shall be

21 for care directly related to the treatment of the ter22 minal illness.

23 ‘‘(c) PERMISSIBLE TERMS AND CONDITIONS.—A

24 group health plan (other than a fully insured group health

25 plan) may condition coverage of continued treatment by
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1 a provider under subsection (a)(1)(B) upon the provider

2 agreeing to the following terms and conditions:

3 ‘‘(1) The provider agrees to accept reimburse4 ment from the plan and individual involved (with re5 spect to cost-sharing) at the rates applicable prior to

6 the start of the transitional period as payment in

7 full (or, in the case described in subsection (b)(2),

8 at the rates applicable under the replacement plan

9 after the date of the termination of the contract with

10 the group health plan) and not to impose cost-shar11 ing with respect to the individual in an amount that

12 would exceed the cost-sharing that could have been

13 imposed if the contract referred to in subsection

14 (a)(1) had not been terminated.

15 ‘‘(2) The provider agrees to adhere to the qual16 ity assurance standards of the plan responsible for

17 payment under paragraph (1) and to provide to such

18 plan necessary medical information related to the

19 care provided.

20 ‘‘(3) The provider agrees otherwise to adhere to

21 such plan’s policies and procedures, including proce22 dures regarding referrals and obtaining prior au23 thorization and providing services pursuant to a

24 treatment plan (if any) approved by the plan.
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1 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec2 tion shall be construed to require the coverage of benefits

3 which would not have been covered if the provider involved

4 remained a participating provider.

5 ‘‘(e) DEFINITION.—In this section, the term ‘health

6 care provider’ or ‘provider’ means—

7 ‘‘(1) any individual who is engaged in the deliv8 ery of health care services in a State and who is re9 quired by State law or regulation to be licensed or

10 certified by the State to engage in the delivery of

11 such services in the State; and

12 ‘‘(2) any entity that is engaged in the delivery

13 of health care services in a State and that, if it is

14 required by State law or regulation to be licensed or

15 certified by the State to engage in the delivery of

16 such services in the State, is so licensed.

17 ‘‘SEC. 726. PROTECTION OF PATIENT-PROVIDER COMMU18 NICATIONS.

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

20 group health plan (other than a fully insured group health

21 plan and in relation to a participant or beneficiary) shall

22 not prohibit or otherwise restrict a health care professional

23 from advising such a participant or beneficiary who is a

24 patient of the professional about the health status of the

25 participant or beneficiary or medical care or treatment for
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1 the condition or disease of the participant or beneficiary,

2 regardless of whether coverage for such care or treatment

3 are provided under the contract, if the professional is act4 ing within the lawful scope of practice.

5 ‘‘(b) RULE OF CONSTRUCTION.—Nothing in this sec6 tion shall be construed as requiring a group health plan

7 (other than a fully insured group health plan) to provide

8 specific benefits under the terms of such plan.

9 ‘‘SEC. 727. GENERALLY APPLICABLE PROVISION.

10 ‘‘In the case of a group health plan that provides ben11 efits under 2 or more coverage options, the requirements

12 of sections 721, 723, 724, 725 and 726 shall apply sepa13 rately with respect to each coverage option.’’.

14 (b) DEFINITION.—Section 733(a) of the Employee

15 Retirement Income Security Act of 1974 (42 U.S.C.

16 1186(a)) is amended by adding at the end the following:

17 ‘‘(3) FULLY INSURED GROUP HEALTH PLAN.—

18 The term ‘fully insured group health plan’ means a

19 group health plan where benefits are provided pursu20 ant to the terms of an arrangement between a group

21 health plan and a health insurance issuer and are

22 guaranteed by the health insurance issuer under a

23 contract or policy of insurance.’’.

24 (c) CONFORMING AMENDMENT.—The table of con25 tents in section 1 of such Act is amended—
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1 (1) in the item relating to subpart C, by strik2 ing ‘‘Subpart C’’ and inserting ‘‘Subpart D’’; and

3 (2) by adding at the end of the items relating

4 to subpart B of part 7 of subtitle B of title I of such

5 Act the following new items:

‘‘SUBPART C—PATIENT RIGHT TO MEDICAL ADVICE AND CARE

‘‘Sec. 721. Patient access to emergency medical care.

‘‘Sec. 722. Offering of choice of coverage options.

‘‘Sec. 723. Patient access to obstetric and gynecological care.

‘‘Sec. 724. Patient access to pediatric care.

‘‘Sec. 725. Continuity of care.

‘‘Sec. 726. Protection of patient-provider communications.

‘‘Sec. 727. Generally applicable provisions.’’.

6 SEC. 102. EFFECTIVE DATE AND RELATED RULES.

7 (a) IN GENERAL.—The amendments made by this

8 subtitle shall apply with respect to plan years beginning

9 on or after January 1 of the second calendar year fol10 lowing the date of the enactment of this Act. The Sec11 retary shall issue all regulations necessary to carry out

12 the amendments made by this section before the effective

13 date thereof.

14 (b) LIMITATION ON ENFORCEMENT ACTIONS.—No

15 enforcement action shall be taken, pursuant to the amend16 ments made by this subtitle, against a group health plan

17 with respect to a violation of a requirement imposed by

18 such amendments before the date of issuance of regula19 tions issued in connection with such requirement, if the

20 plan has sought to comply in good faith with such require21 ment.
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1 Subtitle B—Right to Information

2 About Plans and Providers

3 SEC. 111. INFORMATION ABOUT PLANS.

4 (a) IN GENERAL.—Subpart B of part 7 of subtitle

5 B of title I of the Employee Retirement Income Security

6 Act of 1974, as amended by the Omnibus Consolidated

7 and Emergency Supplemental Appropriations Act, 1999

8 (Public Law 105–277), is amended by adding at the end

9 the following:

10 ‘‘SEC. 714. HEALTH PLAN COMPARATIVE INFORMATION.

11 ‘‘(a) REQUIREMENT.—A group health plan, or health

12 insurance issuer in connection with group health insurance

13 coverage, shall, not later than 12 months after the date

14 of enactment of this section, provide for the disclosure,

15 in a clear and accurate form to each enrollee, or upon re16 quest to a potential enrollee eligible to receive benefits

17 under the plan, or plan sponsor with which the plan or

18 issuer has contracted, of the information described in sub19 section (b).

20 ‘‘(b) REQUIRED INFORMATION.—The informational

21 materials to be distributed under this section shall include

22 for each health benefit plan the following:

23 ‘‘(1) A description of the covered items and

24 services under each such plan and any in- and out25 of-network features of each such plan.
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1 ‘‘(2) A description of any cost-sharing, includ2 ing premiums, deductibles, coinsurance, and copay3 ment amounts, for which the enrollee will be respon4 sible, including any annual or lifetime limits on ben5 efits, for each such plan.

6 ‘‘(3) A description of any optional supplemental

7 benefits offered by each such plan and the terms

8 and conditions (including premiums or cost-sharing)

9 for such supplemental coverage.

10 ‘‘(4) A description of any restrictions on pay11 ments for services furnished to an enrollee by a

12 health care professional that is not a participating

13 professional and the liability of the enrollee for addi14 tional payments for these services.

15 ‘‘(5) A description of the service area of each

16 such plan, including the provision of any out-of-area

17 coverage.

18 ‘‘(6) A description of the extent to which enroll19 ees may select the primary care provider of their

20 choice, including providers both within the network

21 and outside the network of each such plan (if the

22 plan permits out-of-network services).

23 ‘‘(7) A description of the procedures for ad24 vance directives and organ donation decisions if the

25 plan maintains such procedures.
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1 ‘‘(8) A description of the requirements and pro2 cedures to be used to obtain preauthorization for

3 health services (including telephone numbers and

4 mailing addresses), including referrals for specialty

5 care.

6 ‘‘(9) A summary of the rules and methods for

7 appealing coverage decisions and filing grievances

8 (including telephone numbers and mailing address9 es), as well as other available remedies.

10 ‘‘(10) A summary of the rules for access to

11 emergency room care. Also, any available edu12 cational material regarding proper use of emergency

13 services.

14 ‘‘(11) A description of whether or not coverage

15 is provided for experimental treatments, investiga16 tional treatments, or clinical trials and the cir17 cumstances under which access to such treatments

18 or trials is made available.

19 ‘‘(12) A description of the specific preventative

20 services covered under the plan if such services are

21 covered.

22 ‘‘(13) A statement regarding—

23 ‘‘(A) the manner in which an enrollee may

24 access an obstetrician, gynecologist, or pediatri25 cian in accordance with section 723 or 724;
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1 ‘‘(B) the manner in which an enrollee ob2 tains continuity of care as provided for in sec3 tion 725; and

4 ‘‘(C) the manner in which an enrollee has

5 access to the medical records of the enrollee in

6 accordance with subtitle A of title II of the Pa7 tients’ Bill of Rights Act.

8 ‘‘(14) A statement that the following informa9 tion, and instructions on obtaining such information

10 (including telephone numbers and, if available,

11 Internet websites), shall be made available upon re12 quest:

13 ‘‘(A) The names, addresses, telephone

14 numbers, and State licensure status of the

15 plan’s participating health care professionals

16 and participating health care facilities, and, if

17 available, the education, training, speciality

18 qualifications or certifications of such profes19 sionals.

20 ‘‘(B) A summary description of the meth21 ods used for compensating participating health

22 care professionals, such as capitation, fee-for23 service, salary, or a combination thereof. The

24 requirement of this subparagraph shall not be

25 construed as requiring plans to provide infor-
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1 mation concerning proprietary payment meth2 odology.

3 ‘‘(C) A summary description of the meth4 ods used for compensating health care facilities,

5 including per diem, fee-for-service, capitation,

6 bundled payments, or a combination thereof.

7 The requirement of this subparagraph shall not

8 be construed as requiring plans to provide in9 formation concerning proprietary payment

10 methodology.

11 ‘‘(D) A summary description of the proce12 dures used for utilization review.

13 ‘‘(E) The list of the specific prescription

14 medications included in the formulary of the

15 plan, if the plan uses a defined formulary, and

16 any provision for obtaining off-formulary medi17 cations.

18 ‘‘(F) A description of the specific exclu19 sions from coverage under the plan.

20 ‘‘(G) Any available information related to

21 the availability of translation or interpretation

22 services for non-English speakers and people

23 with communication disabilities, including the

24 availability of audio tapes or information in

25 Braille.
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1 ‘‘(H) Any information that is made public

2 by accrediting organizations in the process of

3 accreditation if the plan is accredited, or any

4 additional quality indicators that the plan

5 makes available.

6 ‘‘(c) MANNER OF DISTRIBUTION.—

7 ‘‘(1) IN GENERAL.—The information described

8 in this section shall be distributed in an accessible

9 format that is understandable to an average plan en10 rollee.

11 ‘‘(2) RULE OF CONSTRUCTION.—For purposes

12 of this section, a group health plan, or health insur13 ance issuer in connection with group health insur14 ance coverage, in reliance on records maintained by

15 the plan or issuer, shall be deemed to have met the

16 requirements of this section if the plan or issuer pro17 vides the information requested under this section—

18 ‘‘(A) in the case of the plan, to partici19 pants and beneficiaries at the address contained

20 in such records with respect to such partici21 pants and beneficiaries; or

22 ‘‘(B) in the case of the issuer, to the em23 ployer of a participant if the employer provides

24 for the coverage of such participant under the

25 plan involved or to participants and bene-
26

•S 326 RS

1 ficiaries at the address contained in such

2 records with respect to such participants and

3 beneficiaries.

4 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec5 tion may be construed to prohibit a group health plan,

6 or health insurance issuer in connection with group health

7 insurance coverage, from distributing any other additional

8 information determined by the plan or issuer to be impor9 tant or necessary in assisting participants and bene10 ficiaries enrollees or upon request potential participants

11 in the selection of a health plan or from providing informa12 tion under subsection (b)(13) as part of the required infor13 mation.

14 ‘‘(e) HEALTH CARE PROFESSIONAL.—In this section,

15 the term ‘health care professional’ means a physician (as

16 defined in section 1861(r) of the Social Security Act) or

17 other health care professional if coverage for the profes18 sional’s services is provided under the health plan involved

19 for the services of the professional. Such term includes a

20 podiatrist, optometrist, chiropractor, psychologist, dentist,

21 physician assistant, physical or occupational therapist and

22 therapy assistant, speech-language pathologist, audiol23 ogist, registered or licensed practical nurse (including

24 nurse practitioner, clinical nurse specialist, certified reg25 istered nurse anesthetist, and certified nurse-midwife), li-
27

•S 326 RS

1 censed certified social worker, registered respiratory thera2 pist, and certified respiratory therapy technician.’’.

3 (b) CONFORMING AMENDMENTS.—

4 (1) Section 732(a) of the Employee Retirement

5 Income Security Act of 1974 (29 U.S.C. 1185(a)) is

6 amended by striking ‘‘section 711, and inserting

7 ‘‘sections 711 and 714’’.

8 (2) The table of contents in section 1 of the

9 Employee Retirement Income Security Act of 1974

10 (29 U.S.C. 1001) is amended by inserting after the

11 item relating to section 713, the following:

‘‘Sec. 714. Health plan comparative information.’’.

12 SEC. 112. INFORMATION ABOUT PROVIDERS.

13 (a) STUDY.—The Secretary of Health and Human

14 Services shall enter into a contract with the Institute of

15 Medicine for the conduct of a study, and the submission

16 to the Secretary of a report, that includes—

17 (1) an analysis of information concerning health

18 care professionals that is currently available to pa19 tients, consumers, States, and professional societies,

20 nationally and on a State-by-State basis, including

21 patient preferences with respect to information

22 about such professionals and their competencies;

23 (2) an evaluation of the legal and other barriers

24 to the sharing of information concerning health care

25 professionals; and
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1 (3) recommendations for the disclosure of infor2 mation on health care professionals, including the

3 competencies and professional qualifications of such

4 practitioners, to better facilitate patient choice, qual5 ity improvement, and market competition.

6 (b) REPORT.—Not later than 18 months after the

7 date of enactment of this Act, the Secretary of Health and

8 Human Services shall forward to the appropriate commit9 tees of Congress a copy of the report and study conducted

10 under subsection (a).

11 Subtitle C—Right to Hold Health

12 Plans Accountable

13 SEC. 121. AMENDMENT TO EMPLOYEE RETIREMENT IN14 COME SECURITY ACT OF 1974.

15 (a) IN GENERAL.—Section 503 of the Employee Re16 tirement Income Security Act of 1974 (29 U.S.C. 1133)

17 is amended to read as follows:

18 ‘‘SEC. 503. CLAIMS PROCEDURE, COVERAGE DETERMINA19 TION, GRIEVANCES AND APPEALS.

20 ‘‘(a) CLAIMS PROCEDURE.—In accordance with regu21 lations of the Secretary, every employee benefit plan

22 shall—

23 ‘‘(1) provide adequate notice in writing to any

24 participant or beneficiary whose claim for benefits

25 under the plan has been denied, setting forth the
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1 specific reasons for such denial, written in a manner

2 calculated to be understood by the participant, and

3 ‘‘(2) afford a reasonable opportunity to any

4 participant whose claim for benefits has been denied

5 for a full and fair review by the appropriate named

6 fiduciary of the decision denying the claim.

7 ‘‘(b) COVERAGE DETERMINATIONS UNDER GROUP

8 HEALTH PLANS.—

9 ‘‘(1) PROCEDURES.—

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

11 or health insurance issuer conducting utilization

12 review shall ensure that procedures are in place

13 for—

14 ‘‘(i) making determinations regarding

15 whether an enrollee is eligible to receive a

16 payment or coverage for health services

17 under the plan or coverage involved and

18 any cost-sharing amount that the enrollee

19 is required to pay with respect to such

20 service;

21 ‘‘(ii) notifying covered enrollees (or

22 the legal representative of such enrollees)

23 and the treating health care professionals

24 involved regarding determinations made

25 under the plan or issuer and any addi-
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•S 326 RS

1 tional payments that the enrollee may be

2 required to make with respect to such serv3 ice; and

4 ‘‘(iii) responding to requests, either

5 written or oral, for coverage determina6 tions or for internal appeals from an en7 rollee (or the legal representative of such

8 enrollee) or the treating health care profes9 sional.

10 ‘‘(B) ORAL REQUESTS.—With respect to

11 an oral request described in subparagraph

12 (A)(iii), a group health plan or health insurance

13 issuer may require that the requesting indi14 vidual provide written evidence of such request.

15 ‘‘(2) TIMELINE FOR MAKING DETERMINA16 TIONS.—

17 ‘‘(A) ROUTINE DETERMINATION.—A group

18 health plan or a health insurance issuer shall

19 maintain procedures to ensure that prior au20 thorization determinations concerning the provi21 sion of non-emergency items or services are

22 made within 30 days from the date on which

23 the request for a determination is submitted,

24 except that such period may be extended where

25 certain circumstances exist that are determined
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1 by the Secretary to be beyond control of the

2 plan or issuer.

3 ‘‘(B) EXPEDITED DETERMINATION.—

4 ‘‘(i) IN GENERAL.—A prior authoriza5 tion determination under this subsection

6 shall be made within 72 hours after a re7 quest is received by the plan or issuer

8 under clause (ii) or (iii).

9 ‘‘(ii) REQUEST BY ENROLLEE.—A

10 plan or issuer shall maintain procedures

11 for expediting a prior authorization deter12 mination under this subsection upon the

13 request of an enrollee if, based on such a

14 request, the plan or issuer determines that

15 the normal time for making such a deter16 mination could seriously jeopardize the life

17 or health of the enrollee.

18 ‘‘(iii) DOCUMENTATION BY HEALTH

19 CARE PROFESSIONAL.—A plan or issuer

20 shall maintain procedures for expediting a

21 prior authorization determination under

22 this subsection if the request involved indi23 cates that the treating health care profes24 sional has documented, based on the med25 ical exigencies, that a determination under
32

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1 the procedures described in subparagraph

2 (A) could seriously jeopardize the life or

3 health of the enrollee.

4 ‘‘(C) CONCURRENT DETERMINATIONS.—A

5 plan or issuer shall maintain procedures to cer6 tify or deny coverage of an extended stay or ad7 ditional services.

8 ‘‘(D) RETROSPECTIVE DETERMINATION.—

9 A plan or issuer shall maintain procedures to

10 ensure that, with respect to the retrospective re11 view of a determination made under paragraph

12 (1), the determination shall be made within 30

13 working days of the date on which the plan or

14 issuer receives all necessary information.

15 ‘‘(3) NOTICE OF DETERMINATIONS.—

16 ‘‘(A) ROUTINE DETERMINATION.—With re17 spect to a coverage determination of a plan or

18 issuer under paragraph (2)(A), the plan or

19 issuer shall issue notice of such determination

20 to the enrollee (or the legal representative of

21 the enrollee), and consistent with the medical

22 exigencies of the case, to the treating health

23 care professional involved not later than 2

24 working days after the date on which the deter25 mination is made.
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•S 326 RS

1 ‘‘(B) EXPEDITED DETERMINATION.—With

2 respect to a coverage determination of a plan or

3 issuer under paragraph (2)(B), the plan or

4 issuer shall issue notice of such determination

5 to the enrollee (or the legal representative of

6 the enrollee), and consistent with the medical

7 exigencies of the case, to the treating health

8 care professional involved within the 72 hour

9 period described in paragraph (2)(B).

10 ‘‘(C) CONCURRENT REVIEWS.—With re11 spect to the determination under a plan or

12 issuer under paragraph (1) to certify or deny

13 coverage of an extended stay or additional serv14 ices, the plan or issuer shall issue notice of such

15 determination to the treating health care pro16 fessional and to the enrollee involved (or the

17 legal representative of the enrollee) within 1

18 working day of the date on which the initial no19 tice was issued.

20 ‘‘(D) RETROSPECTIVE REVIEWS.—With re21 spect to the retrospective review under a plan

22 or issuer of a determination made under para23 graph (1), a determination shall be made within

24 30 working days of the date on which the plan

25 or issuer receives all necessary information. The
34

•S 326 RS

1 plan or issuer shall issue written notice of an

2 approval or disapproval of a determination

3 under this subparagraph to the enrollee (or the

4 legal representative of the enrollee) and health

5 care provider involved within 5 working days of

6 the date on which such determination is made.

7 ‘‘(E) REQUIREMENTS OF NOTICE OF AD8 VERSE COVERAGE DETERMINATIONS.—A writ9 ten or electronic notice of an adverse coverage

10 determination under this subsection, or of an

11 expedited adverse coverage determination under

12 paragraph (2)(B), shall be provided to the en13 rollee (or the legal representative of the en14 rollee) and treating health care professional (if

15 any) involved and shall include—

16 ‘‘(i) the reasons for the determination

17 (including the clinical or scientific-evidence

18 based rationale used in making the deter19 mination) written in a manner to be under20 standable to the average enrollee;

21 ‘‘(ii) the procedures for obtaining ad22 ditional information concerning the deter23 mination; and

24 ‘‘(iii) notification of the right to ap25 peal the determination and instructions on
35

•S 326 RS

1 how to initiate an appeal in accordance

2 with subsection (d).

3 ‘‘(c) GRIEVANCES.—A group health plan or a health

4 insurance issuer shall have written procedures for address5 ing grievances between the plan and enrollees. Determina6 tions under such procedures shall be non-appealable.

7 ‘‘(d) INTERNAL APPEAL OF COVERAGE DETERMINA8 TIONS.—

9 ‘‘(1) IN GENERAL.—An enrollee (or the legal

10 representative of the enrollee) and the treating

11 health care professional with the consent of the en12 rollee (or the legal representative of the enrollee),

13 may appeal any adverse coverage determination

14 under subsection (b) under the procedures described

15 in this subsection.

16 ‘‘(2) RECORDS.—A group health plan and a

17 health insurance issuer shall maintain written

18 records, for at least 6 years, with respect to any ap19 peal under this subsection for purposes of internal

20 quality assurance and improvement.

21 ‘‘(3) ROUTINE DETERMINATIONS.—A group

22 health plan or a health insurance issuer shall provide

23 for the consideration of an appeal of an adverse rou24 tine determination under this subsection not later
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•S 326 RS

1 than 30 working days after the date on which a re2 quest for such appeal is received.

3 ‘‘(4) EXPEDITED DETERMINATION.—

4 ‘‘(A) IN GENERAL.—An expedited deter5 mination with respect to an appeal under this

6 subsection shall be made in accordance with the

7 medical exigencies of the case, but in no case

8 more than 72 hours after the request for such

9 appeal is received by the plan or issuer under

10 subparagraph (B) or (C).

11 ‘‘(B) REQUEST BY ENROLLEE.—A plan or

12 issuer shall maintain procedures for expediting

13 a prior authorization determination under this

14 subsection upon the request of an enrollee if,

15 based on such a request, the plan or issuer de16 termines that the normal time for making such

17 a determination could seriously jeopardize the

18 life or health of the enrollee.

19 ‘‘(C) DOCUMENTATION BY HEALTH CARE

20 PROFESSIONAL.—A plan or issuer shall main21 tain procedures for expediting a prior author22 ization determination under this subsection if

23 the request involved indicates that the treating

24 health care professional has documented, based

25 on the medical exigencies that a determination
37

•S 326 RS

1 under the procedures described in paragraph

2 (2) could seriously jeopardize the life or health

3 of the enrollee.

4 ‘‘(5) CONDUCT OF REVIEW.—A review of an ad5 verse coverage determination under this subsection

6 shall be conducted by an individual with appropriate

7 expertise who was not involved in the initial deter8 mination.

9 ‘‘(6) LACK OF MEDICAL NECESSITY.—A review

10 of an appeal under this subsection relating to a de11 termination to deny coverage based on a lack of

12 medical necessity or appropriateness, or based on an

13 experimental or investigational treatment, shall be

14 made only by a physician with appropriate expertise

15 in the field of medicine involved who was not in16 volved in the initial determination.

17 ‘‘(7) NOTICE.—

18 ‘‘(A) IN GENERAL.—Written notice of a

19 determination made under an internal review

20 process shall be issued to the enrollee (or the

21 legal representative of the enrollee) and the

22 treating health care professional not later than

23 2 working days after the completion of the re24 view (or within the 72-hour period referred to

25 in paragraph (4) if applicable).
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1 ‘‘(B) ADVERSE COVERAGE DETERMINA2 TIONS.—With respect to an adverse coverage

3 determination made under this subsection, the

4 notice described in subparagraph (A) shall

5 include—

6 ‘‘(i) the reasons for the determination

7 (including the clinical or scientific-evidence

8 based rationale used in making the deter9 mination) written in a manner to be under10 standable to the average enrollee;

11 ‘‘(ii) the procedures for obtaining ad12 ditional information concerning the deter13 mination; and

14 ‘‘(iii) notification of the right to an

15 external review under subsection (e) and

16 instructions on how to initiate such a re17 view.

18 ‘‘(e) EXTERNAL REVIEW.—

19 ‘‘(1) IN GENERAL.—A group health plan or a

20 health insurance issuer shall have written procedures

21 to permit an enrollee (or the legal representative of

22 the enrollee) access to an external review with re23 spect to a coverage determination concerning a par24 ticular item or service where—
39

•S 326 RS

1 ‘‘(A) the particular item or service in2 volved, when medically appropriate and nec3 essary, is a covered benefit under the terms and

4 conditions of the contract between the plan or

5 issuer and the enrollee;

6 ‘‘(B) the coverage determination involved

7 denied coverage for such item or service because

8 the provision of such item or service—

9 ‘‘(i) does not meet the plan’s or

10 issuer’s requirements for medical appro11 priateness or necessity and the amount in12 volved exceeds a significant financial

13 threshold; or

14 ‘‘(ii) would constitute experimental or

15 investigational treatment and there is a

16 significant risk of placing the life or health

17 of the enrollee in jeopardy; and

18 ‘‘(C) the enrollee has completed the inter19 nal appeals process with respect to such deter20 mination.

21 ‘‘(2) INITIATION OF THE EXTERNAL REVIEW

22 PROCESS.—

23 ‘‘(A) FILING OF REQUEST.—An enrollee

24 (or the legal representative of the enrollee) who

25 desires to have an external review conducted
40

•S 326 RS

1 under this subsection shall file a written request

2 for such a review with the plan or issuer in3 volved not later than 30 working days after the

4 receipt of a final denial of a claim under sub5 section (d). Any such request shall include the

6 consent of the enrollee (or the legal representa7 tive of the enrollee) for the release of medical

8 information and records to external reviewers

9 regarding the enrollee if such information is

10 necessary for the proper conduct of the external

11 review.

12 ‘‘(B) INFORMATION AND NOTICE.—Not

13 later than 5 working days after the receipt of

14 a request under subparagraph (A), or earlier in

15 accordance with the medical exigencies of the

16 case, the plan or issuer involved shall select an

17 external appeals entity under paragraph (3)(A)

18 that shall be responsible for designating an ex19 ternal reviewer under paragraph (3)(B).

20 ‘‘(C) PROVISION OF INFORMATION.—The

21 plan or issuer involved shall forward all nec22 essary information (including medical records,

23 any relevant review criteria, the clinical ration24 ale consistent with the terms and conditions of

25 the contract between the plan or issuer and the
41

•S 326 RS

1 enrollee for the coverage denial, and evidence of

2 the enrollee’s coverage) to the external reviewer

3 selected under paragraph (3)(B).

4 ‘‘(D) NOTIFICATION.—The plan or issuer

5 involved shall send a written notification to the

6 enrollee (or the legal representative of the en7 rollee) and the plan administrator, indicating

8 that an external review has been initiated.

9 ‘‘(3) CONDUCT OF EXTERNAL REVIEW.—

10 ‘‘(A) DESIGNATION OF EXTERNAL AP11 PEALS ENTITY BY PLAN OR ISSUER.—A plan or

12 issuer that receives a request for an external re13 view under paragraph (2)(A) shall designate

14 one of the following entities to serve as the ex15 ternal appeals entity:

16 ‘‘(i) An external review entity licensed

17 or credentialed by a State.

18 ‘‘(ii) A State agency established for

19 the purpose of conducting independent ex20 ternal reviews.

21 ‘‘(iii) Any entity under contract with

22 the Federal Government to provide exter23 nal review services.

24 ‘‘(iv) Any entity accredited as an ex25 ternal review entity by an accrediting body
42

•S 326 RS

1 recognized by the Secretary for such pur2 pose.

3 ‘‘(v) Any fully accredited teaching

4 hospital.

5 ‘‘(vi) Any other entity meeting criteria

6 established by the Secretary for purposes

7 of this subparagraph.

8 ‘‘(B) DESIGNATION OF EXTERNAL RE9 VIEWER BY EXTERNAL APPEALS ENTITY.—The

10 external appeals entity designated under sub11 paragraph (A) shall, not later than 30 days

12 after the date on which such entity is des13 ignated under subparagraph (A), or earlier in

14 accordance with the medical exigencies of the

15 case, designate one or more individuals to serve

16 as external reviewers with respect to a request

17 received under paragraph (2)(A). Such review18 ers shall be independent medical experts who

19 shall—

20 ‘‘(i) be appropriately credentialed or

21 licensed in any State to deliver health care

22 services;

23 ‘‘(ii) not have any material, profes24 sional, familial, or financial affiliation with

25 the case under review, the enrollee in-
43

•S 326 RS

1 volved, the treating health care profes2 sional, the institution where the treatment

3 would take place, or the manufacturer of

4 any drug, device, procedure, or other ther5 apy proposed for the enrollee whose treat6 ment is under review;

7 ‘‘(iii) be experts in the diagnosis or

8 treatment under review and, when reason9 ably available, be of the same speciality of

10 the physician prescribing the treatment in

11 question;

12 ‘‘(iv) receive only reasonable and cus13 tomary compensation from the group

14 health plan or health insurance issuer in

15 connection with the external review that is

16 not contingent on the decision rendered by

17 the reviewer; and

18 ‘‘(v) not be held liable for decisions re19 garding medical determinations (but may

20 be held liable for actions that are arbitrary

21 and capricious).

22 ‘‘(4) STANDARD OF REVIEW.—

23 ‘‘(A) IN GENERAL.—An external reviewer

24 shall—
44

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1 ‘‘(i) make a determination based on

2 the medical necessity, appropriateness, ex3 perimental or investigational nature of the

4 coverage denial;

5 ‘‘(ii) take into consideration any evi6 dence-based decision making or clinical

7 practice guidelines used by the group

8 health plan or health insurance issuer in

9 conducting utilization review; and

10 ‘‘(iii) submit a report on the final de11 terminations of the review involved to—

12 ‘‘(I) the plan or issuer involved;

13 ‘‘(II) the enrollee involved (or the

14 legal representative of the enrollee);

15 and

16 ‘‘(III) the health care profes17 sional involved.

18 ‘‘(B) NOTICE.—The plan or issuer involved

19 shall ensure that the enrollee receives notice,

20 within 30 days after the determination of the

21 independent medical expert, regarding the ac22 tions of the plan or issuer with respect to the

23 determination of such expert under the external

24 review.

25 ‘‘(5) TIMEFRAME FOR REVIEW.—
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1 ‘‘(A) IN GENERAL.—An external reviewer

2 shall complete a review of an adverse coverage

3 determination in accordance with the medical

4 exigencies of the case.

5 ‘‘(B) LIMITATION.—Notwithstanding sub6 paragraph (A), a review described in such sub7 paragraph shall be completed not later than 30

8 working days after the later of—

9 ‘‘(i) the date on which such reviewer

10 is designated; or

11 ‘‘(ii) the date on which all information

12 necessary to completing such review is re13 ceived.

14 ‘‘(6) BINDING DETERMINATION.—The deter15 mination of an external reviewer under this sub16 section shall be binding upon the plan or issuer if

17 the provisions of this subsection or the procedures

18 implemented under such provisions were complied

19 with by the external reviewer.

20 ‘‘(7) STUDY.—Not later than 2 years after the

21 date of enactment of this section, the General Ac22 counting Office shall conduct a study of a statis23 tically appropriate sample of completed external re24 views. Such study shall include an assessment of the

25 process involved during an external review and the
46

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1 basis of decisionmaking by the external reviewer.

2 The results of such study shall be submitted to the

3 appropriate committees of Congress.

4 ‘‘(8) EFFECT ON CERTAIN PROVISIONS.—Noth5 ing in this section shall be construed as affecting or

6 modifying section 514 of this Act with respect to a

7 group health plan.

8 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec9 tion shall be construed to prohibit a plan administrator

10 or plan fiduciary or health plan medical director from re11 questing an external review by an external reviewer with12 out first completing the internal review process.

13 ‘‘(g) DEFINITIONS.—In this section:

14 ‘‘(1) ADVERSE COVERAGE DETERMINATION.—

15 The term ‘adverse coverage determination’ means a

16 coverage determination under the plan which results

17 in a denial of coverage or reimbursement.

18 ‘‘(2) COVERAGE DETERMINATION.—The term

19 ‘coverage determination’ means with respect to items

20 and services for which coverage may be provided

21 under a health plan, a determination of whether or

22 not such items and services are covered or reimburs23 able under the coverage and terms of the contract.

24 ‘‘(3) ENROLLEE.—The term enrollee means a

25 participant or beneficiary.
47

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1 ‘‘(4) GRIEVANCE.—The term ‘grievance’ means

2 any enrollee complaint that does not involve a cov3 erage determination.

4 ‘‘(5) GROUP HEALTH PLAN.—The term ‘group

5 health plan’ shall have the meaning given such term

6 in section 733(a). In applying this paragraph, ex7 cepted benefits described in section 733(c) shall not

8 be treated as benefits consisting of medical care.

9 ‘‘(6) HEALTH INSURANCE COVERAGE.—The

10 term ‘health insurance coverage’ has the meaning

11 given such term in section 733(b)(1). In applying

12 this paragraph, excepted benefits described in sec13 tion 733(c) shall not be treated as benefits con14 sisting of medical care.

15 ‘‘(7) HEALTH INSURER.—The term ‘health in16 surer’ means an insurance company, insurance serv17 ice, or an insurance organization that meets the re18 quirements of section 733(b)(2) and that offers

19 health insurance coverage in connection with a group

20 health plan.

21 ‘‘(8) PRIOR AUTHORIZATION DETERMINA22 TION.—The term ‘prior authorization determination’

23 means a coverage determination prior to the provi24 sion of the items and services as a condition of cov25 erage of the items and services under the coverage.
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1 ‘‘(9) TREATING HEALTH CARE PROFES2 SIONAL.—The term ‘treating health care profes3 sional’ with respect to a group health plan, health

4 insurance issuer or provider sponsored organization

5 means a practitioner who is acting within the scope

6 of their State licensure or certification for the deliv7 ery of health care services and who is primarily re8 sponsible for delivering those services to the enrollee.

9 ‘‘(10) UTILIZATION REVIEW.—The term ‘utili10 zation review’ with respect to a group health plan or

11 health insurance coverage means a set of formal

12 techniques designed to monitor the use of, or evalu13 ate the clinical necessity, appropriateness, efficacy,

14 or efficiency of, health care services, procedures, or

15 settings. Techniques may include ambulatory review,

16 prospective review, second opinion, certification, con17 current review, case management, discharge plan18 ning or retrospective review.’’

19 (b) ENFORCEMENT.—Section 502(c)(1) of the Em20 ployee Retirement Income Security Act of 1974 (29

21 U.S.C. 1132(c)(1)) is amended by inserting after ‘‘or sec22 tion 101(e)(1)’’ the following: ‘‘, or fails to comply with

23 a coverage determination as required under section

24 503(e)(6),’’.
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1 (c) CONFORMING AMENDMENT.—The table of con2 tents in section 1 of the Employee Retirement Income Se3 curity Act of 1974 is amended by striking the item relat4 ing to section 503 and inserting the following new item:

‘‘Sec. 503. Claims procedures, coverage determination, grievances and appeals.’’.

5 (d) EFFECTIVE DATE.—The amendments made by

6 this section shall apply with respect to plan years begin7 ning on or after 1 year after the date of enactment of

8 this Act. The Secretary shall issue all regulations nec9 essary to carry out the amendments made by this section

10 before the effective date thereof.

11 TITLE II—INDIVIDUAL RIGHTS

12 WITH RESPECT TO PERSONAL

13 MEDICAL INFORMATION

14 SEC. 201. SHORT TITLE.

15 This title may be cited as the ‘‘Personal Medical In16 formation Access Act’’.

17 Subtitle A—Access to Medical

18 Records

19 SEC. 211. INSPECTION AND COPYING OF PROTECTED

20 HEALTH INFORMATION.

21 (a) IN GENERAL.—At the request of an individual

22 and except as provided in subsection (b), a health care

23 provider, health plan, employer, health or life insurer,

24 school, or university shall permit an individual who is the

25 subject of protected health information or the individual’s
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1 designee, to inspect and copy protected health information

2 concerning the individual, including records created under

3 section 212 that such entity maintains. Such entity may

4 set forth appropriate procedures to be followed for such

5 inspection or copying and may require an individual to pay

6 reasonable costs associated with such inspection or copy7 ing.

8 (b) EXCEPTIONS.—Unless ordered by a court of com9 petent jurisdiction, an entity described in subsection (a)

10 is not required to permit the inspection or copying of pro11 tected health information if any of the following conditions

12 are met:

13 (1) ENDANGERMENT TO LIFE OR SAFETY.—

14 The entity determines that the disclosure of the in15 formation could reasonably be expected to endanger

16 the life or physical safety of an individual.

17 (2) CONFIDENTIAL SOURCE.—The information

18 identifies, or could reasonably lead to the identifica19 tion of, a person who provided information under a

20 promise of confidentiality concerning the individual

21 who is the subject of the information.

22 (3) INFORMATION COMPILED IN ANTICIPATION

23 OF LITIGATION.—The information is compiled

24 principally—
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1 (A) in the reasonable anticipation of a

2 civil, criminal, or administrative action or pro3 ceeding; or

4 (B) for use in such an action or pro5 ceeding.

6 (4) RESEARCH PURPOSES.—The information

7 was collected for a research project monitored by an

8 institutional review board, such project is not com9 plete, and the researcher involved reasonably believes

10 that access to such information would harm the con11 duct of the research or invalidate or undermine the

12 validity of the research.

13 (c) DENIAL OF A REQUEST FOR INSPECTION OR

14 COPYING.—If an entity described in subsection (a) denies

15 a request for inspection or copying pursuant to subsection

16 (b), the entity shall inform the individual in writing of—

17 (1) the reasons for the denial of the request for

18 inspection or copying;

19 (2) any procedures for further review of the de20 nial; and

21 (3) the individual’s right to file with the entity

22 a concise statement setting forth the request for in23 spection or copying.

24 (d) STATEMENT REGARDING REQUEST.—If an indi25 vidual has filed a statement under subsection (c)(3), the
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1 entity in any subsequent disclosure of the portion of the

2 information requested under subsection (a) shall include—

3 (1) a copy of the individual’s statement; and

4 (2) a concise statement of the reasons for deny5 ing the request for inspection or copying.

6 (e) INSPECTION AND COPYING OF SEGREGABLE POR7 TION.—An entity described in subsection (a) shall permit

8 the inspection and copying under subsection (a) of any

9 reasonably segregable portion of protected health informa10 tion after deletion of any portion that is exempt under

11 subsection (b).

12 (f) DEADLINE.—An entity described in subsection (a)

13 shall comply with or deny, in accordance with subsection

14 (c), a request for inspection or copying of protected health

15 information under this section not later than 45 days after

16 the date on which the entity receives the request.

17 (g) RULES GOVERNING AGENTS.—An agent of an en18 tity described in subsection (a) shall not be required to

19 provide for the inspection and copying of protected health

20 information, except where—

21 (1) the protected health information is retained

22 by the agent; and

23 (2) the agent has received in writing a request

24 from the entity involved to fulfill the requirements of

25 this section;
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1 at which time such information shall be provided to the

2 requesting entity. Such requesting entity shall comply with

3 subsection (f) with respect to any such information.

4 (h) RULE OF CONSTRUCTION.—This section shall not

5 be construed to require an entity described in subsection

6 (a) to conduct a formal, informal, or other hearing or pro7 ceeding concerning a request for inspection or copying of

8 protected health information.

9 SEC. 212. AMENDMENT OF PROTECTED HEALTH INFORMA10 TION.

11 (a) REQUIREMENT.—

12 (1) IN GENERAL.—Except as provided in sub13 section (b) and subject to paragraph (2), a health

14 care provider, health plan, employer, health or life

15 insurer, school, or university that receives from an

16 individual a request in writing to amend protected

17 health information shall—

18 (A) amend such information as requested;

19 (B) inform the individual of the amend20 ment that has been made; and

21 (C) make reasonable efforts to inform any

22 person to whom the unamended portion of the

23 information was previously disclosed, of any

24 nontechnical amendment that has been made.
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1 (2) COMPLIANCE.—An entity described in para2 graph (1) shall comply with the requirements of

3 such paragraph within 45 days of the date on which

4 the request involved is received if the entity—

5 (A) created the protected health informa6 tion involved; and

7 (B) determines that such information is in

8 fact inaccurate.

9 (b) REFUSAL TO AMEND.—If an entity described in

10 subsection (a) refuses to make the amendment requested

11 under such subsection, the entity shall inform the indi12 vidual in writing of—

13 (1) the reasons for the refusal to make the

14 amendment;

15 (2) any procedures for further review of the re16 fusal; and

17 (3) the individual’s right to file with the entity

18 a concise statement setting forth the requested

19 amendment and the individual’s reasons for dis20 agreeing with the refusal.

21 (c) STATEMENT OF DISAGREEMENT.—If an indi22 vidual has filed a statement of disagreement under sub23 section (b)(3), the entity involved, in any subsequent dis24 closure of the disputed portion of the information—
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1 (1) shall include a copy of the individual’s

2 statement; and

3 (2) may include a concise statement of the rea4 sons for not making the requested amendment.

5 (d) RULES GOVERNING AGENTS.—The agent of an

6 entity described in subsection (a) shall not be required to

7 make amendments to protected health information, except

8 where—

9 (1) the protected health information is retained

10 by the agent; and

11 (2) the agent has been asked by such entity to

12 fulfill the requirements of this section.

13 If the agent is required to comply with this section as pro14 vided for in paragraph (2), such agent shall be subject

15 to the 45-day deadline described in subsection (a).

16 (e) REPEATED REQUESTS FOR AMENDMENTS.—If an

17 entity described in subsection (a) receives a request for

18 an amendment of information as provided for in such sub19 section and a statement of disagreement has been filed

20 pursuant to subsection (c), the entity shall inform the indi21 vidual of such filing and shall not be required to carry

22 out the procedures required under this section.

23 (f) RULES OF CONSTRUCTION.—This section shall

24 not be construed to—
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1 (1) require that an entity described in sub2 section (a) conduct a formal, informal, or other

3 hearing or proceeding concerning a request for an

4 amendment to protected health information;

5 (2) require a provider to amend an individual’s

6 protected health information as to the type, dura7 tion, or quality of treatment the individual believes

8 he or she should have been provided; or

9 (3) permit any deletions or alterations of the

10 original information.

11 SEC. 213. NOTICE OF CONFIDENTIALITY PRACTICES.

12 (a) PREPARATION OF WRITTEN NOTICE.—A health

13 care provider, health plan, health oversight agency, public

14 health authority, employer, health or life insurer, health

15 researcher, school or university shall post or provide, in

16 writing and in a clear and conspicuous manner, notice of

17 the entity’s confidentiality practices, that shall include—

18 (1) a description of an individual’s rights with

19 respect to protected health information;

20 (2) the procedures established by the entity for

21 the exercise of the individual’s rights; and

22 (3) the right to obtain a copy of the notice of

23 the confidentiality practices required under this sub24 title.
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1 (b) MODEL NOTICE.—The Secretary, in consultation

2 with the National Committee on Vital and Health Statis3 tics and the National Association of Insurance Commis4 sioners, and after notice and opportunity for public com5 ment, shall develop and disseminate model notices of con6 fidentiality practices. Use of the model notice shall serve

7 as a defense against claims of receiving inappropriate no8 tice.

9 Subtitle B—Establishment of

10 Safeguards

11 SEC. 221. ESTABLISHMENT OF SAFEGUARDS.

12 A health care provider, health plan, health oversight

13 agency, public health authority, employer, health or life

14 insurer, health researcher, law enforcement official, school

15 or university shall establish and maintain appropriate ad16 ministrative, technical, and physical safeguards to protect

17 the confidentiality, security, accuracy, and integrity of

18 protected health information created, received, obtained,

19 maintained, used, transmitted, or disposed of by such enti20 ty.

21 Subtitle C—Enforcement;

22 Definitions

23 SEC. 231. CIVIL PENALTY.

24 (a) VIOLATION.—A health care provider, health re25 searcher, health plan, health oversight agency, public
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1 health agency, law enforcement agency, employer, health

2 or life insurer, school, or university, or the agent of any

3 such individual or entity, who the Secretary, in consulta4 tion with the Attorney General, determines has substan5 tially and materially failed to comply with this Act shall,

6 for a violation of this title, be subject, in addition to any

7 other penalties that may be prescribed by law, to a civil

8 penalty of not more than $500 for each such violation,

9 but not to exceed $5,000 in the aggregate for multiple vio10 lations.

11 (b) PROCEDURES FOR IMPOSITION OF PENALTIES.—

12 Section 1128A of the Social Security Act, other than sub13 sections (a) and (b) and the second sentence of subsection

14 (f) of that section, shall apply to the imposition of a civil,

15 monetary, or exclusionary penalty under this section in the

16 same manner as such provisions apply with respect to the

17 imposition of a penalty under section 1128A of such Act.

18 SEC. 232. DEFINITIONS.

19 In this title:

20 (1) AGENT.—The term ‘‘agent’’ means a person

21 who represents and acts for another under the con22 tract or relation of agency, or whose function is to

23 bring about, modify, affect, accept performance of,

24 or terminate contractual obligations between the

25 principal and a third person, including a contractor.
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1 (2) DISCLOSE.—The term ‘‘disclose’’ means to

2 release, transfer, provide access to, or otherwise di3 vulge protected health information to any person

4 other than the individual who is the subject of such

5 information. Such term includes the initial disclosure

6 and any subsequent redisclosures of protected health

7 information.

8 (3) EMPLOYER.—The term ‘‘employer’’ has the

9 meaning given such term under section 3(5) of the

10 Employee Retirement Income Security Act of 1974

11 (29 U.S.C. 1002(5)), except that such term shall in12 clude only employers of 2 or more employees.

13 (4) HEALTH CARE PROVIDER.—The term

14 ‘‘health care provider’’ means a person who, with re15 spect to a specific item of protected health informa16 tion, receives, creates, uses, maintains, or discloses

17 the information while acting in whole or in part in

18 the capacity of—

19 (A) a person who is licensed, certified, reg20 istered, or otherwise authorized by Federal or

21 State law to provide an item or service that

22 constitutes health care in the ordinary course of

23 business, or practice of a profession;

24 (B) a Federal, State, or employer-spon25 sored program that directly provides items or
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1 services that constitute health care to bene2 ficiaries; or

3 (C) an officer, employee, or agent of a per4 son described in subparagraph (A) or (B).

5 (5) HEALTH OR LIFE INSURER.—The term

6 ‘‘health or life insurer’’ means a health insurance

7 issuer as defined in section 2791 of the Public

8 Health Service Act (42 U.S.C. 300gg–91) or a life

9 insurance company as defined in section 816 of the

10 Internal Revenue Code of 1986.

11 (6) HEALTH PLAN.—The term ‘‘health plan’’

12 means any health insurance plan, including any hos13 pital or medical service plan, dental or other health

14 service plan or health maintenance organization

15 plan, provider sponsored organization, or other pro16 gram providing or arranging for the provision of

17 health benefits, whether or not funded through the

18 purchase of insurance.

19 (7) PERSON.—The term ‘‘person’’ means a gov20 ernment, governmental subdivision, agency or au21 thority; corporation; company; association; firm;

22 partnership; society; estate; trust; joint venture; indi23 vidual; individual representative; tribal government;

24 and any other legal entity.
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1 (8) PROTECTED HEALTH INFORMATION.—The

2 term ‘‘protected health information’’ means any in3 formation (including demographic information)

4 whether or not recorded in any form or medium—

5 (A) that relates to the past, present or

6 future—

7 (i) physical or mental health or condi8 tion of an individual (including the condi9 tion or other attributes of individual cells

10 or their components);

11 (ii) provision of health care to an indi12 vidual; or

13 (iii) payment for the provision of

14 health care to an individual;

15 (B) that is created by a health care pro16 vider, health plan, health researcher, health

17 oversight agency, public health authority, em18 ployer, law enforcement official, health or life

19 insurer, school or university; and

20 (C) that is not nonidentifiable health infor21 mation.

22 (9) SCHOOL OR UNIVERSITY.—The term

23 ‘‘school or university’’ means an institution or place

24 for instruction or education, including an elementary

25 school, secondary school, or institution of higher
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1 learning, a college, or an assemblage of colleges

2 united under one corporate organization or govern3 ment.

4 (10) SECRETARY.—The term ‘‘Secretary’’

5 means the Secretary of Health and Human Services.

6 (11) WRITING.—The term ‘‘writing’’ means

7 writing in either a paper-based or computer-based

8 form, including electronic signatures.

9 SEC. 233. EFFECTIVE DATE.

10 The provisions of this title shall become effective be11 ginning on the date that is 1 year after the date of enact12 ment of this Act. The Secretary shall issue regulations

13 necessary to carry out this title before the effective date

14 thereof.

15 TITLE III—GENETIC

16 INFORMATION AND SERVICES

17 SEC. 301. SHORT TITLE.

18 This title may be cited as the ‘‘Genetic Information

19 Nondiscrimination in Health Insurance Act of 1999’’.

20 SEC. 302. AMENDMENTS TO EMPLOYEE RETIREMENT IN21 COME SECURITY ACT OF 1974.

22 (a) PROHIBITION OF HEALTH DISCRIMINATION ON

23 THE BASIS OF GENETIC INFORMATION OR GENETIC

24 SERVICES.—
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1 (1) NO ENROLLMENT RESTRICTION FOR GE2 NETIC SERVICES.—Section 702(a)(1)(F) of the Em3 ployee Retirement Income Security Act of 1974 (29

4 U.S.C. 1182(a)(1)(F)) is amended by inserting be5 fore the period the following: ‘‘(including informa6 tion about a request for or receipt of genetic serv7 ices)’’.

8 (2) NO DISCRIMINATION IN GROUP PREMIUMS

9 BASED ON PREDICTIVE GENETIC INFORMATION.—

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

11 Employee Retirement Income Security Act of 1974

12 (29 U.S.C. 1185 et seq.) (as amended by section

13 111) is further amended by adding at the end the

14 following:

15 ‘‘SEC. 714. PROHIBITING PREMIUM DISCRIMINATION

16 AGAINST GROUPS ON THE BASIS OF PRE17 DICTIVE GENETIC INFORMATION.

18 ‘‘A group health plan, or a health insurance issuer

19 offering group health insurance coverage in connection

20 with a group health plan, shall not adjust premium or con21 tribution amounts for a group on the basis of predictive

22 genetic information concerning an individual in the group

23 or a family member of the individual (including informa24 tion about a request for or receipt of genetic services).’’.
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1 (3) CONFORMING AMENDMENT.—Section

2 702(b) of the Employee Retirement Income Security

3 Act of 1974 (29 U.S.C. 1182(b)) is amended by

4 adding at the end the following:

5 ‘‘(3) REFERENCE TO RELATED PROVISION.—

6 For a provision prohibiting the adjustment of pre7 mium or contribution amounts for a group under a

8 group health plan on the basis of predictive genetic

9 information (including information about a request

10 for or receipt of genetic services), see section 714.’’.

11 (b) LIMITATION ON COLLECTION OF PREDICTIVE

12 GENETIC INFORMATION.—Section 702 of the Employee

13 Retirement Income Security Act of 1974 (29 U.S.C. 1182)

14 is amended by adding at the end the following:

15 ‘‘(c) COLLECTION OF PREDICTIVE GENETIC INFOR16 MATION.—

17 ‘‘(1) LIMITATION ON REQUESTING OR REQUIR18 ING PREDICTIVE GENETIC INFORMATION.—Except

19 as provided in paragraph (2), a group health plan,

20 or a health insurance issuer offering health insur21 ance coverage in connection with a group health

22 plan, shall not request or require predictive genetic

23 information concerning an individual or a family

24 member of the individual (including information

25 about a request for or receipt of genetic services).
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1 ‘‘(2) INFORMATION NEEDED FOR DIAGNOSIS,

2 TREATMENT, OR PAYMENT.—

3 ‘‘(A) IN GENERAL.—Notwithstanding para4 graph (1), a group health plan or health insur5 ance issuer that provides health care items and

6 services to an individual or dependent may re7 quest (but may not require) that such indi8 vidual or dependent disclose, or authorize the

9 collection or disclosure of, predictive genetic in10 formation for purposes of diagnosis, treatment,

11 or payment relating to the provision of health

12 care items and services to such individual or de13 pendent.

14 ‘‘(B) NOTICE OF CONFIDENTIALITY PRAC15 TICES AND DESCRIPTION OF SAFEGUARDS.—As

16 a part of a request under subparagraph (A),

17 the group health plan or health insurance issuer

18 shall provide to the individual or dependent a

19 description of the procedures in place to safe20 guard the confidentiality, as described in sec21 tions 213 and 221 of the Patients’ Bill of

22 Rights Act, of such individually identifiable in23 formation.’’.
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1 (c) DEFINITIONS.—Section 733(d) of the Employee

2 Retirement Income Security Act of 1974 (29 U.S.C.

3 1191b(d)) is amended by adding at the end the following:

4 ‘‘(5) FAMILY MEMBER.—The term ‘family

5 member’ means with respect to an individual—

6 ‘‘(A) the spouse of the individual;

7 ‘‘(B) a dependent child of the individual,

8 including a child who is born to or placed for

9 adoption with the individual; and

10 ‘‘(C) all other individuals related by blood

11 to the individual or the spouse or child de12 scribed in subparagraph (A) or (B).

13 ‘‘(6) GENETIC INFORMATION.—The term ‘ge14 netic information’ means information about genes,

15 gene products, or inherited characteristics that may

16 derive from an individual or a family member (in17 cluding information about a request for or receipt of

18 genetic services).

19 ‘‘(7) GENETIC SERVICES.—The term ‘genetic

20 services’ means health services provided to obtain,

21 assess, or interpret genetic information for diag22 nostic and therapeutic purposes, and for genetic

23 education and counseling.

24 ‘‘(8) PREDICTIVE GENETIC INFORMATION.—
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1 ‘‘(A) IN GENERAL.—The term ‘predictive

2 genetic information’ means—

3 ‘‘(i) information about an individual’s

4 genetic tests which are associated with a

5 statistically significant increased risk of

6 developing a disease or disorder;

7 ‘‘(ii) information about genetic tests

8 of family members of the individual; or

9 ‘‘(iii) information about the occur10 rence of a disease or disorder in family

11 members that predicts a statistically sig12 nificant increased risk of a disease or dis13 order in the individual.

14 ‘‘(B) EXCEPTIONS.—The term ‘predictive

15 genetic information’ shall not include—

16 ‘‘(i) information about the sex or age

17 of the individual;

18 ‘‘(ii) information derived from routine

19 physical tests, such as the chemical, blood,

20 or urine analyses of the individual, unless

21 such analyses are genetic tests; and

22 ‘‘(iii) information about physical

23 exams of the individual and other informa24 tion relevant to determining the current

25 health status of the individual so long as
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1 such information does not include informa2 tion described in clauses (i), (ii), or (iii) of

3 subparagraph (A).

4 ‘‘(9) GENETIC TEST.—The term ‘genetic test’

5 means the analysis of human DNA, RNA, chro6 mosomes, proteins, and certain metabolites, in order

7 to detect disease-related genotypes, mutations,

8 phenotypes, or karyotypes.’’.

9 (d) EFFECTIVE DATE.—Except as provided in this

10 section, this section and the amendments made by this

11 section shall apply with respect to group health plans for

12 plan years beginning 1 year after the date of the enact13 ment of this Act.

14 SEC. 303. AMENDMENTS TO THE PUBLIC HEALTH SERVICE

15 ACT.

16 (a) AMENDMENTS RELATING TO THE GROUP MAR17 KET.—

18 (1) PROHIBITION OF HEALTH DISCRIMINATION

19 ON THE BASIS OF GENETIC INFORMATION IN THE

20 GROUP MARKET.—

21 (A) IN GENERAL.—Subpart 2 of part A of

22 title XXVII of the Public Health Service Act,

23 as amended by the Omnibus Consolidated and

24 Emergency Supplemental Appropriations Act,
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1 1999 (Public Law 105-277), is amended by

2 adding at the end the following new section:

3 ‘‘SEC. 2707. PROHIBITING PREMIUM DISCRIMINATION

4 AGAINST GROUPS ON THE BASIS OF PRE5 DICTIVE GENETIC INFORMATION IN THE

6 GROUP MARKET.

7 ‘‘A group health plan, or a health insurance issuer

8 offering group health insurance coverage in connection

9 with a group health plan shall not adjust premium or con10 tribution amounts for a group on the basis of predictive

11 genetic information concerning an individual in the group

12 or a family member of the individual (including informa13 tion about a request for or receipt of genetic services).’’.

14 (B) CONFORMING AMENDMENT.—Section

15 2702(b) of the Public Health Service Act (42

16 U.S.C. 300gg–1(b)) is amended by adding at

17 the end the following:

18 ‘‘(3) REFERENCE TO RELATED PROVISION.—

19 For a provision prohibiting the adjustment of pre20 mium or contribution amounts for a group under a

21 group health plan on the basis of predictive genetic

22 information (including information about a request

23 for or receipt of genetic services), see section 2707.’’.

24 (C) LIMITATION ON COLLECTION AND DIS25 CLOSURE OF PREDICTIVE GENETIC INFORMA-
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1 TION.—Section 2702 of the Public Health Serv2 ice Act (42 U.S.C. 300gg–1) is amended by

3 adding at the end the following:

4 ‘‘(c) COLLECTION OF PREDICTIVE GENETIC INFOR5 MATION.—

6 ‘‘(1) LIMITATION ON REQUESTING OR REQUIR7 ING PREDICTIVE GENETIC INFORMATION.—Except

8 as provided in paragraph (2), a group health plan,

9 or a health insurance issuer offering health insur10 ance coverage in connection with a group health

11 plan, shall not request or require predictive genetic

12 information concerning an individual or a family

13 member of the individual (including information

14 about a request for or receipt of genetic services).

15 ‘‘(2) INFORMATION NEEDED FOR DIAGNOSIS,

16 TREATMENT, OR PAYMENT.—

17 ‘‘(A) IN GENERAL.—Notwithstanding para18 graph (1), a group health plan or health insur19 ance issuer that provides health care items and

20 services to an individual or dependent may re21 quest (but may not require) that such indi22 vidual or dependent disclose, or authorize the

23 collection or disclosure of, predictive genetic in24 formation for purposes of diagnosis, treatment,

25 or payment relating to the provision of health
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1 care items and services to such individual or de2 pendent.

3 ‘‘(B) NOTICE OF CONFIDENTIALITY PRAC4 TICES AND DESCRIPTION OF SAFEGUARDS.—As

5 a part of a request under subparagraph (A),

6 the group health plan or health insurance issuer

7 shall provide to the individual or dependent a

8 description of the procedures in place to safe9 guard the confidentiality, as described in sec10 tions 213 and 221 of the Patients’ Bill of

11 Rights Act, of such individually identifiable in12 formation.’’.

13 (2) DEFINITIONS.—Section 2791(d) of the Pub14 lic Health Service Act (42 U.S.C. 300gg–91(d)) is

15 amended by adding at the end the following:

16 ‘‘(15) FAMILY MEMBER.—The term ‘family

17 member’ means, with respect to an individual—

18 ‘‘(A) the spouse of the individual;

19 ‘‘(B) a dependent child of the individual,

20 including a child who is born to or placed for

21 adoption with the individual; and

22 ‘‘(C) all other individuals related by blood

23 to the individual or the spouse or child de24 scribed in subparagraph (A) or (B).
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1 ‘‘(16) GENETIC INFORMATION.—The term ‘ge2 netic information’ means information about genes,

3 gene products, or inherited characteristics that may

4 derive from an individual or a family member.

5 ‘‘(17) GENETIC SERVICES.—The term ‘genetic

6 services’ means health services provided to obtain,

7 assess, or interpret genetic information for diag8 nostic and therapeutic purposes, and for genetic

9 education and counseling.

10 ‘‘(18) PREDICTIVE GENETIC INFORMATION.—

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

12 genetic information’ means—

13 ‘‘(i) information about an individual’s

14 genetic tests which is associated with a

15 statistically significant increased risk of

16 developing a disease or disorder;

17 ‘‘(ii) information about genetic tests

18 of family members of the individual; or

19 ‘‘(iii) information about the occur20 rence of a disease or disorder in family

21 members that predicts a statistically sig22 nificant increased risk of a disease or dis23 order in the individual.

24 ‘‘(B) EXCEPTIONS.—The term ‘predictive

25 genetic information’ shall not include—
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1 ‘‘(i) information about the sex or age

2 of the individual;

3 ‘‘(ii) information derived from routine

4 physical tests, such as the chemical, blood,

5 or urine analyses of the individual, unless

6 such analyses are genetic tests; and

7 ‘‘(iii) information about physical

8 exams of the individual and other informa9 tion relevant to determining the current

10 health status of the individual so long as

11 such information does not include informa12 tion described in clauses (i), (ii), or (iii) of

13 subparagraph (A).

14 ‘‘(19) GENETIC TEST.—The term ‘genetic test’

15 means the analysis of human DNA, RNA, chro16 mosomes, proteins, and certain metabolites, in order

17 to detect disease-related genotypes, mutations,

18 phenotypes, or karyotypes.’’.

19 (b) AMENDMENT RELATING TO THE INDIVIDUAL

20 MARKET.—The first subpart 3 of part B of title XXVII

21 of the Public Health Service Act (42 U.S.C. 300gg–11 et

22 seq.) (relating to other requirements), as amended by the

23 Omnibus Consolidated and Emergency Supplemental Ap24 propriations Act, 1999 (Public Law 105-277) is

25 amended—
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1 (1) by redesignating such subpart as subpart 2;

2 and

3 (2) by adding at the end the following:

4 ‘‘SEC. 2753. PROHIBITION OF HEALTH DISCRIMINATION ON

5 THE BASIS OF PREDICTIVE GENETIC INFOR6 MATION.

7 ‘‘(a) PROHIBITION ON PREDICTIVE GENETIC INFOR8 MATION AS A CONDITION OF ELIGIBILITY.—A health in9 surance issuer offering health insurance coverage in the

10 individual market may not use predictive genetic informa11 tion as a condition of eligibility of an individual to enroll

12 in individual health insurance coverage (including infor13 mation about a request for or receipt of genetic services).

14 ‘‘(b) PROHIBITION ON PREDICTIVE GENETIC INFOR15 MATION IN SETTING PREMIUM RATES.—A health insur16 ance issuer offering health insurance coverage in the indi17 vidual market shall not adjust premium rates for individ18 uals on the basis of predictive genetic information con19 cerning such an enrollee or a family member of the en20 rollee (including information about a request for or receipt

21 of genetic services).

22 ‘‘(c) COLLECTION OF PREDICTIVE GENETIC INFOR23 MATION.—

24 ‘‘(1) LIMITATION ON REQUESTING OR REQUIR25 ING PREDICTIVE GENETIC INFORMATION.—Except
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1 as provided in paragraph (2), a health insurance

2 issuer offering health insurance coverage in the indi3 vidual market shall not request or require predictive

4 genetic information concerning an individual or a

5 family member of the individual (including informa6 tion about a request for or receipt of genetic serv7 ices).

8 ‘‘(2) INFORMATION NEEDED FOR DIAGNOSIS,

9 TREATMENT, OR PAYMENT.—

10 ‘‘(A) IN GENERAL.—Notwithstanding para11 graph (1), a health insurance issuer that pro12 vides health care items and services to an indi13 vidual or dependent may request (but may not

14 require) that such individual or dependent dis15 close, or authorize the collection or disclosure

16 of, predictive genetic information for purposes

17 of diagnosis, treatment, or payment relating to

18 the provision of health care items and services

19 to such individual or dependent.

20 ‘‘(B) NOTICE OF CONFIDENTIALITY PRAC21 TICES AND DESCRIPTION OF SAFEGUARDS.—As

22 a part of a request under subparagraph (A),

23 the health insurance issuer shall provide to the

24 individual or dependent a description of the

25 procedures in place to safeguard the confiden-
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1 tiality, as described in sections 213 and 221 of

2 the Patients’ Bill of Rights Act, of such individ3 ually identifiable information.’’.

4 (c) EFFECTIVE DATE.—The amendments made by

5 this section shall apply with respect to—

6 (1) group health plans, and health insurance

7 coverage offered in connection with group health

8 plans, for plan years beginning after 1 year after the

9 date of enactment of this Act; and

10 (2) health insurance coverage offered, sold,

11 issued, renewed, in effect, or operated in the indi12 vidual market after 1 year after the date of enact13 ment of this Act.

14 TITLE IV—HEALTHCARE

15 RESEARCH AND QUALITY

16 SEC. 401. SHORT TITLE.

17 This title may be cited as the ‘‘Healthcare Research

18 and Quality Act of 1999’’.

19 SEC. 402. AMENDMENT TO THE PUBLIC HEALTH SERVICE

20 ACT.

21 Title IX of the Public Health Service Act (42 U.S.C.

22 299 et seq.) is amended to read as follows:
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1 ‘‘TITLE IX—AGENCY FOR

2 HEALTHCARE RESEARCH

3 AND QUALITY

4 ‘‘PART A—ESTABLISHMENT AND GENERAL

5 DUTIES

6 ‘‘SEC. 901. MISSION AND DUTIES.

7 ‘‘(a) IN GENERAL.—There is established within the

8 Public Health Service an agency to be known as the Agen9 cy for Healthcare Research and Quality. In carrying out

10 this subsection, the Secretary shall redesignate the Agency

11 for Health Care Policy and Research as the Agency for

12 Healthcare Research and Quality.

13 ‘‘(b) MISSION.—The purpose of the Agency is to en14 hance the quality, appropriateness, and effectiveness of

15 healthcare services, and access to such services, through

16 the establishment of a broad base of scientific research

17 and through the promotion of improvements in clinical

18 and health system practice, including the prevention of

19 diseases and other health conditions. The Agency shall

20 promote healthcare quality improvement by—

21 ‘‘(1) conducting and supporting research that

22 develops and presents scientific evidence regarding

23 all aspects of healthcare, including—

24 ‘‘(A) the development and assessment of

25 methods for enhancing patient participation in
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1 their own care and for facilitating shared pa2 tient-physician decision-making;

3 ‘‘(B) the outcomes, effectiveness, and cost4 effectiveness of healthcare practices, including

5 preventive measures and primary, acute and

6 long-term care;

7 ‘‘(C) existing and innovative technologies;

8 ‘‘(D) the costs and utilization of, and ac9 cess to healthcare;

10 ‘‘(E) the ways in which healthcare services

11 are organized, delivered, and financed and the

12 interaction and impact of these factors on the

13 quality of patient care;

14 ‘‘(F) methods for measuring quality and

15 strategies for improving quality; and

16 ‘‘(G) ways in which patients, consumers,

17 purchasers, and practitioners acquire new infor18 mation about best practices and health benefits,

19 the determinants and impact of their use of this

20 information;

21 ‘‘(2) synthesizing and disseminating available

22 scientific evidence for use by patients, consumers,

23 practitioners, providers, purchasers, policy makers,

24 and educators; and
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1 ‘‘(3) advancing private and public efforts to im2 prove healthcare quality.

3 ‘‘(c) REQUIREMENTS WITH RESPECT TO RURAL

4 AREAS AND PRIORITY POPULATIONS.—In carrying out

5 subsection (b), the Director shall undertake and support

6 research, demonstration projects, and evaluations with re7 spect to—

8 ‘‘(1) the delivery of health services in rural

9 areas (including frontier areas);

10 ‘‘(2) health services for low-income groups, and

11 minority groups;

12 ‘‘(3) the health of children;

13 ‘‘(4) the elderly; and

14 ‘‘(5) people with special healthcare needs, in15 cluding disabilities, chronic care and end-of-life

16 healthcare.

17 ‘‘(d) APPOINTMENT OF DIRECTOR.—There shall be

18 at the head of the Agency an official to be known as the

19 Director for Healthcare Research and Quality. The Direc20 tor shall be appointed by the Secretary. The Secretary,

21 acting through the Director, shall carry out the authorities

22 and duties established in this title.

23 ‘‘SEC. 902. GENERAL AUTHORITIES.

24 ‘‘(a) IN GENERAL.—In carrying out section 901(b),

25 the Director shall support demonstration projects, conduct
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1 and support research, evaluations, training, research net2 works, multi-disciplinary centers, technical assistance, and

3 the dissemination of information, on healthcare, and on

4 systems for the delivery of such care, including activities

5 with respect to—

6 ‘‘(1) the quality, effectiveness, efficiency, appro7 priateness and value of healthcare services;

8 ‘‘(2) quality measurement and improvement;

9 ‘‘(3) the outcomes, cost, cost-effectiveness, and

10 use of healthcare services and access to such serv11 ices;

12 ‘‘(4) clinical practice, including primary care

13 and practice-oriented research;

14 ‘‘(5) healthcare technologies, facilities, and

15 equipment;

16 ‘‘(6) healthcare costs, productivity, organiza17 tion, and market forces;

18 ‘‘(7) health promotion and disease prevention,

19 including clinical preventive services;

20 ‘‘(8) health statistics, surveys, database devel21 opment, and epidemiology; and

22 ‘‘(9) medical liability.

23 ‘‘(b) HEALTH SERVICES TRAINING GRANTS.—

24 ‘‘(1) IN GENERAL.—The Director may provide

25 training grants in the field of health services re-
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1 search related to activities authorized under sub2 section (a), to include pre- and post-doctoral fellow3 ships and training programs, young investigator

4 awards, and other programs and activities as appro5 priate. In carrying out this subsection, the Director

6 shall make use of funds made available under sec7 tion 487.

8 ‘‘(2) REQUIREMENTS.—In developing priorities

9 for the allocation of training funds under this sub10 section, the Director shall take into consideration

11 shortages in the number of trained researchers ad12 dressing the priority populations.

13 ‘‘(c) MULTIDISCIPLINARY CENTERS.—The Director

14 may provide financial assistance to assist in meeting the

15 costs of planning and establishing new centers, and oper16 ating existing and new centers, for multidisciplinary

17 health services research, demonstration projects, evalua18 tions, training, and policy analysis with respect to the mat19 ters referred to in subsection (a).

20 ‘‘(d) RELATION TO CERTAIN AUTHORITIES REGARD21 ING SOCIAL SECURITY.—Activities authorized in this sec22 tion may include, and shall be appropriately coordinated

23 with experiments, demonstration projects, and other re24 lated activities authorized by the Social Security Act and

25 the Social Security Amendments of 1967. Activities under
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1 subsection (a)(2) of this section that affect the programs

2 under titles XVIII, XIX and XXI of the Social Security

3 Act shall be carried out consistent with section 1142 of

4 such Act.

5 ‘‘(e) DISCLAIMER.—The Agency shall not mandate

6 national standards of clinical practice or quality

7 healthcare standards. Recommendations resulting from

8 projects funded and published by the Agency shall include

9 a corresponding disclaimer.

10 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec11 tion shall be construed to imply that the Agency’s role is

12 to mandate a national standard or specific approach to

13 quality measurement and reporting. In research and qual14 ity improvement activities, the Agency shall consider a

15 wide range of choices, providers, healthcare delivery sys16 tems, and individual preferences.

17 ‘‘PART B—HEALTHCARE IMPROVEMENT

18 RESEARCH

19 ‘‘SEC. 911. HEALTHCARE OUTCOME IMPROVEMENT RE20 SEARCH.

21 ‘‘(a) EVIDENCE RATING SYSTEMS.—In collaboration

22 with experts from the public and private sector, the Agen23 cy shall identify and disseminate methods or systems used

24 to assess healthcare research results, particularly to rate

25 the strength of the scientific evidence behind healthcare
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1 practice, recommendations in the research literature, and

2 technology assessments. The Agency shall make methods

3 or systems for evidence rating widely available. Agency

4 publications containing healthcare recommendations shall

5 indicate the level of substantiating evidence using such

6 methods or systems.

7 ‘‘(b) HEALTHCARE IMPROVEMENT RESEARCH CEN8 TERS AND PROVIDER-BASED RESEARCH NETWORKS.—

9 ‘‘(1) IN GENERAL.—In order to address the full

10 continuum of care and outcomes research, to link re11 search to practice improvement, and to speed the

12 dissemination of research findings to community

13 practice settings, the Agency shall employ research

14 strategies and mechanisms that will link research di15 rectly with clinical practice in geographically diverse

16 locations throughout the United States, including—

17 ‘‘(A) Healthcare Improvement Research

18 Centers that combine demonstrated multidisci19 plinary expertise in outcomes or quality im20 provement research with linkages to relevant

21 sites of care;

22 ‘‘(B) Provider-based Research Networks,

23 including plan, facility, or delivery system sites

24 of care (especially primary care), that can

25 evaluate and promote quality improvement; and
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1 ‘‘(C) other innovative mechanisms or strat2 egies to link research with clinical practice.

3 ‘‘(2) REQUIREMENTS.—The Director is author4 ized to establish the requirements for entities apply5 ing for grants under this subsection.

6 ‘‘SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE

7 ORGANIZATION AND DELIVERY.

8 ‘‘(a) SUPPORT FOR EFFORTS TO DEVELOP INFOR9 MATION ON QUALITY.—

10 ‘‘(1) SCIENTIFIC AND TECHNICAL SUPPORT.—

11 In its role as the principal agency for healthcare re12 search and quality, the Agency may provide sci13 entific and technical support for private and public

14 efforts to improve healthcare quality, including the

15 activities of accrediting organizations.

16 ‘‘(2) ROLE OF THE AGENCY.—With respect to

17 paragraph (1), the role of the Agency shall include—

18 ‘‘(A) the identification and assessment

19 of—

20 ‘‘(i) methods for the evaluation of the

21 health of enrollees in health plans by type

22 of plan, provider, and provider arrange23 ments; and

24 ‘‘(ii) other populations, including

25 those receiving long-term care services;
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1 ‘‘(B) the ongoing development, testing, and

2 dissemination of quality measures, including

3 measures of health and functional outcomes;

4 ‘‘(C) the compilation and dissemination of

5 healthcare quality measures developed in the

6 private and public sector;

7 ‘‘(D) assistance in the development of im8 proved healthcare information systems;

9 ‘‘(E) the development of survey tools for

10 the purpose of measuring participant and bene11 ficiary assessments of their healthcare; and

12 ‘‘(F) identifying and disseminating infor13 mation on mechanisms for the integration of in14 formation on quality into purchaser and con15 sumer decision-making processes.

16 ‘‘(b) CENTERS FOR EDUCATION AND RESEARCH ON

17 THERAPEUTICS.—

18 ‘‘(1) IN GENERAL.—The Secretary, acting

19 through the Director and in consultation with the

20 Commissioner of Food and Drugs, shall establish a

21 program for the purpose of making one or more

22 grants for the establishment and operation of one or

23 more centers to carry out the activities specified in

24 paragraph (2).
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1 ‘‘(2) REQUIRED ACTIVITIES.—The activities re2 ferred to in this paragraph are the following:

3 ‘‘(A) The conduct of state-of-the-art clin4 ical research for the following purposes:

5 ‘‘(i) To increase awareness of—

6 ‘‘(I) new uses of drugs, biological

7 products, and devices;

8 ‘‘(II) ways to improve the effec9 tive use of drugs, biological products,

10 and devices; and

11 ‘‘(III) risks of new uses and risks

12 of combinations of drugs and biologi13 cal products.

14 ‘‘(ii) To provide objective clinical in15 formation to the following individuals and

16 entities:

17 ‘‘(I) Healthcare practitioners and

18 other providers of Healthcare goods or

19 services.

20 ‘‘(II) Pharmacists, pharmacy

21 benefit managers and purchasers.

22 ‘‘(III) Health maintenance orga23 nizations and other managed

24 healthcare organizations.
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1 ‘‘(IV) Healthcare insurers and

2 governmental agencies.

3 ‘‘(V) Patients and consumers.

4 ‘‘(iii) To improve the quality of

5 healthcare while reducing the cost of

6 Healthcare through—

7 ‘‘(I) an increase in the appro8 priate use of drugs, biological prod9 ucts, or devices; and

10 ‘‘(II) the prevention of adverse

11 effects of drugs, biological products,

12 and devices and the consequences of

13 such effects, such as unnecessary hos14 pitalizations.

15 ‘‘(B) The conduct of research on the com16 parative effectiveness, cost-effectiveness, and

17 safety of drugs, biological products, and devices.

18 ‘‘(C) Such other activities as the Secretary

19 determines to be appropriate, except that a

20 grant may not be expended to assist the Sec21 retary in the review of new drugs.

22 ‘‘(c) REDUCING ERRORS IN MEDICINE.—The Direc23 tor shall conduct and support research and build private24 public partnerships to—
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1 ‘‘(1) identify the causes of preventable

2 healthcare errors and patient injury in healthcare

3 delivery;

4 ‘‘(2) develop, demonstrate, and evaluate strate5 gies for reducing errors and improving patient safe6 ty; and

7 ‘‘(3) promote the implementation of effective

8 strategies throughout the healthcare industry.

9 ‘‘SEC. 913. INFORMATION ON QUALITY AND COST OF CARE.

10 ‘‘(a) IN GENERAL.—In carrying out 902(a), the Di11 rector shall—

12 ‘‘(1) collect data on a nationally representative

13 sample of the population on the cost, use and, for

14 fiscal year 2000 and subsequent fiscal years, quality

15 of healthcare, including the types of healthcare serv16 ices Americans use, their access to healthcare serv17 ices, frequency of use, how much is paid for the

18 services used, the source of those payments, the

19 types and costs of private health insurance, access,

20 satisfaction, and quality of care for the general pop21 ulation and also for children, uninsured persons,

22 poor and near-poor individuals, and persons with

23 special healthcare needs;
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1 ‘‘(2) develop databases and tools that enable

2 States to track the quality, access, and use of

3 healthcare services provided to their residents; and

4 ‘‘(3) enter into agreements with public or pri5 vate entities to use, link, or acquire databases for re6 search authorized under this title.

7 ‘‘(b) QUALITY AND OUTCOMES INFORMATION.—

8 ‘‘(1) IN GENERAL.—To enhance the under9 standing of the quality of care, the determinants of

10 health outcomes and functional status, the needs of

11 special populations as well as an understanding of

12 these changes over time, their relationship to

13 healthcare access and use, and to monitor the overall

14 national impact of Federal and State policy changes

15 on healthcare, the Director, beginning in fiscal year

16 2000, shall ensure that the survey conducted under

17 subsection (a)(1) will—

18 ‘‘(A) provide information on the quality of

19 care and patient outcomes for frequently occur20 ring clinical conditions for a nationally rep21 resentative sample of the population; and

22 ‘‘(B) provide reliable national estimates for

23 children and persons with special healthcare

24 needs through the use of supplements or peri25 odic expansions of the survey.
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1 In expanding the Medical Expenditure Panel Survey,

2 as in existence on the date of enactment of this title)

3 in fiscal year 2000 to collect information on the

4 quality of care, the Director shall take into account

5 any outcomes measurements generally collected by

6 private sector accreditation organizations.

7 ‘‘(2) ANNUAL REPORT.—Beginning in fiscal

8 year 2002, the Secretary, acting through the Direc9 tor, shall submit to Congress an annual report on

10 national trends in the quality of healthcare provided

11 to the American people.

12 ‘‘SEC. 914. INFORMATION SYSTEMS FOR HEALTHCARE IM13 PROVEMENT.

14 ‘‘In order to foster a range of innovative approaches

15 to the management and communication of health informa16 tion, the Agency shall support research, evaluations and

17 initiatives to advance—

18 ‘‘(1) the use of information systems for the

19 study of healthcare quality, including the generation

20 of both individual provider and plan-level compara21 tive performance data;

22 ‘‘(2) training for healthcare practitioners and

23 researchers in the use of information systems;
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1 ‘‘(3) the creation of effective linkages between

2 various sources of health information, including the

3 development of information networks;

4 ‘‘(4) the delivery and coordination of evidence5 based healthcare services, including the use of real6 time healthcare decision-support programs;

7 ‘‘(5) the structure, content, definition, and cod8 ing of health information data and medical vocabu9 laries in consultation with appropriate Federal and

10 private entities;

11 ‘‘(6) the use of computer-based health records

12 in outpatient and inpatient settings as a personal

13 health record for individual health assessment and

14 maintenance, and for monitoring public health and

15 outcomes of care within populations; and

16 ‘‘(7) the protection of individually identifiable

17 information in health services research and

18 healthcare quality improvement.

19 ‘‘SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND

20 ACCESS IN UNDERSERVED AREAS.

21 ‘‘(a) PREVENTIVE SERVICES TASK FORCE.—

22 ‘‘(1) PURPOSE.—The Agency shall provide on23 going administrative, research, and technical support

24 for the operation of the Preventive Services Task

25 Force. The Agency shall coordinate and support the
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1 dissemination of the Preventive Services Task Force

2 recommendations.

3 ‘‘(2) OPERATION.—The Preventive Services

4 Task Force shall review the scientific evidence re5 lated to the effectiveness, appropriateness, and cost6 effectiveness of clinical preventive services for the

7 purpose of developing recommendations, and updat8 ing previous recommendations, regarding their use9 fulness in daily clinical practice. In carrying out its

10 responsibilities under paragraph (1), the Task Force

11 shall not be subject to the provisions of Appendix 2

12 of title 5, United States Code.

13 ‘‘(b) PRIMARY CARE RESEARCH.—

14 ‘‘(1) IN GENERAL.—There is established within

15 the Agency a Center for Primary Care Research (re16 ferred to in this subsection as the ‘Center’) that

17 shall serve as the principal source of funding for pri18 mary care research in the Department of Health and

19 Human Services. For purposes of this paragraph,

20 primary care research focuses on the first contact

21 when illness or health concerns arise, the diagnosis,

22 treatment or referral to specialty care, preventive

23 care, and the relationship between the clinician and

24 the patient in the context of the family and commu25 nity.
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1 ‘‘(2) RESEARCH.—In carrying out this section,

2 the Center shall conduct and support research on—

3 ‘‘(A) the nature and characteristics of pri4 mary care practice;

5 ‘‘(B) the management of commonly occur6 ring clinical problems;

7 ‘‘(C) the management of undifferentiated

8 clinical problems; and

9 ‘‘(D) the continuity and coordination of

10 health services.

11 ‘‘(3) DEMONSTRATION.—The Agency shall sup12 port demonstrations into the use of new information

13 tools aimed at improving shared decision-making be14 tween patients and their care-givers.

15 ‘‘SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVA16 TION.

17 ‘‘(a) IN GENERAL.—The Director shall promote inno18 vation in evidence-based clinical practice and healthcare

19 technologies by—

20 ‘‘(1) conducting and supporting research on the

21 development, diffusion, and use of healthcare tech22 nology;

23 ‘‘(2) developing, evaluating, and disseminating

24 methodologies for assessments of healthcare prac25 tices and healthcare technologies;
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1 ‘‘(3) conducting intramural and supporting ex2 tramural assessments of existing and new healthcare

3 practices and technologies;

4 ‘‘(4) promoting education, training, and pro5 viding technical assistance in the use of healthcare

6 practice and healthcare technology assessment meth7 odologies and results; and

8 ‘‘(5) working with the National Library of Med9 icine and the public and private sector to develop an

10 electronic clearinghouse of currently available assess11 ments and those in progress.

12 ‘‘(b) SPECIFICATION OF PROCESS.—

13 ‘‘(1) IN GENERAL.—Not later than December

14 31, 2000, the Director shall develop and publish a

15 description of the methods used by the Agency and

16 its contractors for practice and technology assess17 ment.

18 ‘‘(2) CONSULTATIONS.—In carrying out this

19 subsection, the Director shall cooperate and consult

20 with the Assistance Secretary for Health, the Ad21 ministrator of the Health Care Financing Adminis22 tration, the Director of the National Institutes of

23 Health, the Commissioner of Food and Drugs, and

24 the heads of any other interested Federal depart-
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1 ment or agency, professional societies, and other pri2 vate and public entities.

3 ‘‘(3) METHODOLOGY.—The methods employed

4 in practice and technology assessments under para5 graph (1) shall consider—

6 ‘‘(A) safety, efficacy, and effectiveness;

7 ‘‘(B) legal, social, and ethical implications;

8 ‘‘(C) costs, benefits, and cost-effectiveness;

9 ‘‘(D) comparisons to alternative tech10 nologies and practices; and

11 ‘‘(E) requirements of Food and Drug Ad12 ministration approval to avoid duplication.

13 ‘‘(c) SPECIFIC ASSESSMENTS.—

14 ‘‘(1) IN GENERAL.—The Director shall conduct

15 or support specific assessments of healthcare tech16 nologies and practices.

17 ‘‘(2) REQUESTS FOR ASSESSMENTS.—The Di18 rector is authorized to conduct or support assess19 ments, on a reimbursable basis, for the Health Care

20 Financing Administration, the Department of De21 fense, the Department of Veterans Affairs, the Of22 fice of Personnel Management, and other public or

23 private entities.

24 ‘‘(3) GRANTS AND CONTRACTS.—In addition to

25 conducting assessments, the Director may make
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1 grants to, or enter into cooperative agreements or

2 contracts with, entities described in paragraph (4)

3 for the purpose of conducting assessments of experi4 mental, emerging, existing, or potentially outmoded

5 healthcare technologies, and for related activities.

6 ‘‘(4) ELIGIBLE ENTITIES.—An entity described

7 in this paragraph is an entity that is determined to

8 be appropriate by the Director, including academic

9 medical centers, research institutions, professional

10 organizations, third party payers, other govern11 mental agencies, and consortia of appropriate re12 search entities established for the purpose of con13 ducting technology assessments.

14 ‘‘SEC. 917. COORDINATION OF FEDERAL GOVERNMENT

15 QUALITY IMPROVEMENT EFFORTS.

16 ‘‘(a) REQUIREMENT.—

17 ‘‘(1) IN GENERAL.—To avoid duplication and

18 ensure that Federal resources are used efficiently

19 and effectively, the Secretary, acting through the Di20 rector, shall coordinate all research, evaluations, and

21 demonstrations related to health services research

22 and quality measurement and improvement activities

23 undertaken and supported by the Federal Govern24 ment.
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1 ‘‘(2) SPECIFIC ACTIVITIES.—The Director, in

2 collaboration with the appropriate Federal officials

3 representing all concerned executive agencies and de4 partments, shall develop and manage a process to—

5 ‘‘(A) improve interagency coordination, pri6 ority setting, and the use and sharing of re7 search findings and data pertaining to Federal

8 quality improvement programs and health serv9 ices research;

10 ‘‘(B) strengthen the research information

11 infrastructure, including databases, pertaining

12 to Federal health services research and

13 healthcare quality improvement initiatives;

14 ‘‘(C) set specific goals for participating

15 agencies and departments to further health

16 services research and healthcare quality im17 provement; and

18 ‘‘(D) strengthen the management of Fed19 eral healthcare quality improvement programs.

20 ‘‘(b) STUDY BY THE INSTITUTE OF MEDICINE.—

21 ‘‘(1) IN GENERAL.—To provide the Department

22 of Health and Human Services with an independent,

23 external review of its quality oversight, and quality

24 research programs, the Secretary shall enter into a

25 contract with the Institute of Medicine—
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1 ‘‘(A) to describe and evaluate current qual2 ity improvement research and monitoring proc3 esses through—

4 ‘‘(i) an overview of pertinent health

5 services research activities and quality im6 provement efforts including those currently

7 performed by the peer review organizations

8 and the exploration of additional activities

9 that could be undertaken by the peer re10 view organizations to improve quality;

11 ‘‘(ii) an analysis of the various part12 nership activities that the Department of

13 Health and Human Services has pursued

14 with private sector accreditation and other

15 quality measurement organizations;

16 ‘‘(iii) the exploration of programmatic

17 areas where partnership activities between

18 the Federal Government and the private

19 sector or within the Federal Government

20 could be pursued to improve quality over21 sight of the medicare, medicaid and child

22 health insurance programs under titles

23 XVIII, XIX and XXI of the Social Secu24 rity Act; and
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1 ‘‘(iv) an identification of opportunities

2 for enhancing health system efficiency

3 through simplification and reduction in re4 dundancy of Federal agency quality im5 provement efforts, including areas in which

6 Federal efforts unnecessarily duplicate ex7 isting private sector efforts; and

8 ‘‘(B) to identify options and make rec9 ommendations to improve the efficiency and ef10 fectiveness of such quality improvement pro11 grams through—

12 ‘‘(i) the improved coordination of ac13 tivities across the medicare, medicaid and

14 child health insurance programs under ti15 tles XVIII, XIX and XXI of the Social Se16 curity Act and various health services re17 search programs;

18 ‘‘(ii) the strengthening of patient

19 choice and participation by incorporating

20 state-of-the-art quality monitoring tools

21 and making information on quality avail22 able; and

23 ‘‘(iii) the enhancement of the most ef24 fective programs, consolidation as appro-
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1 priate, and elimination of duplicative ac2 tivities within various federal agencies.

3 ‘‘(2) REQUIREMENTS.—

4 ‘‘(A) IN GENERAL.—The Secretary shall

5 enter into a contract with the Institute of Medi6 cine for the preparation—

7 ‘‘(i) not later than 12 months after

8 the date of enactment of this title, of a re9 port providing an overview of the quality

10 improvement programs of the Department

11 of Health and Human Services for the

12 medicare, medicaid, and CHIP programs

13 under titles XVIII, XIX, and XXI of the

14 Social Security Act; and

15 ‘‘(ii) not later than 24 months after

16 the date of enactment of this title, of a

17 final report containing recommendations.

18 ‘‘(B) REPORTS.—The Secretary shall sub19 mit the reports described in subparagraph (A)

20 to the Committee on Finance and the Com21 mittee on Health, Education, Labor, and Pen22 sions of the Senate and the Committee on Ways

23 and Means and the Committee on Commerce of

24 the House of Representatives.
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1 ‘‘PART C—GENERAL PROVISIONS

2 ‘‘SEC. 921. ADVISORY COUNCIL FOR HEALTHCARE RE3 SEARCH AND QUALITY.

4 ‘‘(a) ESTABLISHMENT.—There is established an advi5 sory council to be known as the Advisory Council for

6 Healthcare Research and Quality.

7 ‘‘(b) DUTIES.—

8 ‘‘(1) IN GENERAL.—The Advisory Council shall

9 advise the Secretary and the Director with respect

10 to activities proposed or undertaken to carry out the

11 purpose of the Agency under section 901(b).

12 ‘‘(2) CERTAIN RECOMMENDATIONS.—Activities

13 of the Advisory Council under paragraph (1) shall

14 include making recommendations to the Director

15 regarding—

16 ‘‘(A) priorities regarding healthcare re17 search, especially studies related to quality, out18 comes, cost and the utilization of, and access

19 to, healthcare services;

20 ‘‘(B) the field of healthcare research and

21 related disciplines, especially issues related to

22 training needs, and dissemination of informa23 tion pertaining to healthcare quality; and

24 ‘‘(C) the appropriate role of the Agency in

25 each of these areas in light of private sector ac-
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1 tivity and identification of opportunities for

2 public-private sector partnerships.

3 ‘‘(c) MEMBERSHIP.—

4 ‘‘(1) IN GENERAL.—The Advisory Council shall,

5 in accordance with this subsection, be composed of

6 appointed members and ex officio members. All

7 members of the Advisory Council shall be voting

8 members other than the individuals designated

9 under paragraph (3)(B) as ex officio members.

10 ‘‘(2) APPOINTED MEMBERS.—The Secretary

11 shall appoint to the Advisory Council 21 appro12 priately qualified individuals. At least 17 members of

13 the Advisory Council shall be representatives of the

14 public who are not officers or employees of the

15 United States. The Secretary shall ensure that the

16 appointed members of the Council, as a group, are

17 representative of professions and entities concerned

18 with, or affected by, activities under this title and

19 under section 1142 of the Social Security Act. Of

20 such members—

21 ‘‘(A) 4 shall be individuals distinguished in

22 the conduct of research, demonstration projects,

23 and evaluations with respect to healthcare;
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1 ‘‘(B) 4 shall be individuals distinguished in

2 the practice of medicine of which at least 1

3 shall be a primary care practitioner;

4 ‘‘(C) 3 shall be individuals distinguished in

5 the other health professions;

6 ‘‘(D) 4 shall be individuals either rep7 resenting the private healthcare sector, includ8 ing health plans, providers, and purchasers or

9 individuals distinguished as administrators of

10 healthcare delivery systems;

11 ‘‘(E) 4 shall be individuals distinguished in

12 the fields of healthcare quality improvement, ec13 onomics, information systems, law, ethics, busi14 ness, or public policy; and

15 ‘‘(F) 2 shall be individuals representing the

16 interests of patients and consumers of

17 healthcare.

18 ‘‘(3) EX OFFICIO MEMBERS.—The Secretary

19 shall designate as ex officio members of the Advisory

20 Council—

21 ‘‘(A) the Assistant Secretary for Health,

22 the Director of the National Institutes of

23 Health, the Director of the Centers for Disease

24 Control and Prevention, the Administrator of

25 the Health Care Financing Administration, the
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1 Assistant Secretary of Defense (Health Af2 fairs), and the Chief Medical Officer of the De3 partment of Veterans Affairs; and

4 ‘‘(B) such other Federal officials as the

5 Secretary may consider appropriate.

6 ‘‘(d) TERMS.—Members of the Advisory Council ap7 pointed under subsection (c)(2) shall serve for a term of

8 3 years. A member of the Council appointed under such

9 subsection may continue to serve after the expiration of

10 the term of the members until a successor is appointed.

11 ‘‘(e) VACANCIES.—If a member of the Advisory

12 Council appointed under subsection (c)(2) does not serve

13 the full term applicable under subsection (d), the indi14 vidual appointed to fill the resulting vacancy shall be ap15 pointed for the remainder of the term of the predecessor

16 of the individual.

17 ‘‘(f) CHAIR.—The Director shall, from among the

18 members of the Advisory Council appointed under sub19 section (c)(2), designate an individual to serve as the chair

20 of the Advisory Council.

21 ‘‘(g) MEETINGS.—The Advisory Council shall meet

22 not less than once during each discrete 4-month period

23 and shall otherwise meet at the call of the Director or the

24 chair.
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1 ‘‘(h) COMPENSATION AND REIMBURSEMENT OF EX2 PENSES.—

3 ‘‘(1) APPOINTED MEMBERS.—Members of the

4 Advisory Council appointed under subsection (c)(2)

5 shall receive compensation for each day (including

6 travel time) engaged in carrying out the duties of

7 the Advisory Council unless declined by the member.

8 Such compensation may not be in an amount in ex9 cess of the maximum rate of basic pay payable for

10 GS–18 of the General Schedule.

11 ‘‘(2) EX OFFICIO MEMBERS.—Officials des12 ignated under subsection (c)(3) as ex officio mem13 bers of the Advisory Council may not receive com14 pensation for service on the Advisory Council in ad15 dition to the compensation otherwise received for du16 ties carried out as officers of the United States.

17 ‘‘(i) STAFF.—The Director shall provide to the Advi18 sory Council such staff, information, and other assistance

19 as may be necessary to carry out the duties of the Council.

20 ‘‘SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND

21 CONTRACTS.

22 ‘‘(a) REQUIREMENT OF REVIEW.—

23 ‘‘(1) IN GENERAL.—Appropriate technical and

24 scientific peer review shall be conducted with respect
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1 to each application for a grant, cooperative agree2 ment, or contract under this title.

3 ‘‘(2) REPORTS TO DIRECTOR.—Each peer re4 view group to which an application is submitted pur5 suant to paragraph (1) shall report its finding and

6 recommendations respecting the application to the

7 Director in such form and in such manner as the

8 Director shall require.

9 ‘‘(b) APPROVAL AS PRECONDITION OF AWARDS.—

10 The Director may not approve an application described in

11 subsection (a)(1) unless the application is recommended

12 for approval by a peer review group established under sub13 section (c).

14 ‘‘(c) ESTABLISHMENT OF PEER REVIEW GROUPS.—

15 ‘‘(1) IN GENERAL.—The Director shall establish

16 such technical and scientific peer review groups as

17 may be necessary to carry out this section. Such

18 groups shall be established without regard to the

19 provisions of title 5, United States Code, that govern

20 appointments in the competitive service, and without

21 regard to the provisions of chapter 51, and sub22 chapter III of chapter 53, of such title that relate

23 to classification and pay rates under the General

24 Schedule.
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1 ‘‘(2) MEMBERSHIP.—The members of any peer

2 review group established under this section shall be

3 appointed from among individuals who by virtue of

4 their training or experience are eminently qualified

5 to carry out the duties of such peer review group.

6 Officers and employees of the United States may not

7 constitute more than 25 percent of the membership

8 of any such group. Such officers and employees may

9 not receive compensation for service on such groups

10 in addition to the compensation otherwise received

11 for these duties carried out as such officers and em12 ployees.

13 ‘‘(3) DURATION.—Notwithstanding section

14 14(a) of the Federal Advisory Committee Act, peer

15 review groups established under this section may

16 continue in existence until otherwise provided by

17 law.

18 ‘‘(4) QUALIFICATIONS.—Members of any peer19 review group shall, at a minimum, meet the fol20 lowing requirements:

21 ‘‘(A) Such members shall agree in writing

22 to treat information received, pursuant to their

23 work for the group, as confidential information,

24 except that this subparagraph shall not apply to

25 public records and public information.
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1 ‘‘(B) Such members shall agree in writing

2 to recuse themselves from participation in the

3 peer-review of specific applications which

4 present a potential personal conflict of interest

5 or appearance of such conflict, including em6 ployment in a directly affected organization,

7 stock ownership, or any financial or other ar8 rangement that might introduce bias in the

9 process of peer-review.

10 ‘‘(d) AUTHORITY FOR PROCEDURAL ADJUSTMENTS

11 IN CERTAIN CASES.—In the case of applications for finan12 cial assistance whose direct costs will not exceed $100,000,

13 the Director may make appropriate adjustments in the

14 procedures otherwise established by the Director for the

15 conduct of peer review under this section. Such adjust16 ments may be made for the purpose of encouraging the

17 entry of individuals into the field of research, for the pur18 pose of encouraging clinical practice-oriented or provider19 based research, and for such other purposes as the Direc20 tor may determine to be appropriate.

21 ‘‘(e) REGULATIONS.—The Director may shall issue

22 regulations for the conduct of peer review under this sec23 tion.
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1 ‘‘SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVEL2 OPMENT, COLLECTION, AND DISSEMINATION

3 OF DATA.

4 ‘‘(a) STANDARDS WITH RESPECT TO UTILITY OF

5 DATA.—

6 ‘‘(1) IN GENERAL.—To ensure the utility, accu7 racy, and sufficiency of data collected by or for the

8 Agency for the purpose described in section 901(b),

9 the Director shall establish standards and methods

10 for developing and collecting such data, taking into

11 consideration—

12 ‘‘(A) other Federal health data collection

13 standards; and

14 ‘‘(B) the differences between types of

15 healthcare plans, delivery systems, healthcare

16 providers, and provider arrangements.

17 ‘‘(2) RELATIONSHIP WITH OTHER DEPARTMENT

18 PROGRAMS.—In any case where standards under

19 paragraph (1) may affect the administration of other

20 programs carried out by the Department of Health

21 and Human Services, including the programs under

22 titles XVIII, XIX and XXI of the Social Security

23 Act, they shall be in the form of recommendations

24 to the Secretary for such program.

25 ‘‘(b) STATISTICS AND ANALYSES.—The Director

26 shall—
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1 ‘‘(1) take appropriate action to ensure that sta2 tistics and analyses developed under this title are of

3 high quality, timely, and duly comprehensive, and

4 that the statistics are specific, standardized, and

5 adequately analyzed and indexed; and

6 ‘‘(2) publish, make available, and disseminate

7 such statistics and analyses on as wide a basis as is

8 practicable.

9 ‘‘(c) AUTHORITY REGARDING CERTAIN REQUESTS.—

10 Upon request of a public or private entity, the Director

11 may conduct or support research or analyses otherwise au12 thorized by this title pursuant to arrangements under

13 which such entity will pay the cost of the services provided.

14 Amounts received by the Director under such arrange15 ments shall be available to the Director for obligation until

16 expended.

17 ‘‘SEC. 924. DISSEMINATION OF INFORMATION.

18 ‘‘(a) IN GENERAL.—The Director shall—

19 ‘‘(1) without regard to section 501 of title 44,

20 United States Code, promptly publish, make avail21 able, and otherwise disseminate, in a form under22 standable and on as broad a basis as practicable so

23 as to maximize its use, the results of research, dem24 onstration projects, and evaluations conducted or

25 supported under this title;
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1 ‘‘(2) ensure that information disseminated by

2 the Agency is science-based and objective and under3 takes consultation as necessary to assess the appro4 priateness and usefulness of the presentation of in5 formation that is targeted to specific audiences;

6 ‘‘(3) promptly make available to the public data

7 developed in such research, demonstration projects,

8 and evaluations;

9 ‘‘(4) provide, in collaboration with the National

10 Library of Medicine where appropriate, indexing, ab11 stracting, translating, publishing, and other services

12 leading to a more effective and timely dissemination

13 of information on research, demonstration projects,

14 and evaluations with respect to healthcare to public

15 and private entities and individuals engaged in the

16 improvement of healthcare delivery and the general

17 public, and undertake programs to develop new or

18 improved methods for making such information

19 available; and

20 ‘‘(5) as appropriate, provide technical assistance

21 to State and local government and health agencies

22 and conduct liaison activities to such agencies to fos23 ter dissemination.

24 ‘‘(b) PROHIBITION AGAINST RESTRICTIONS.—Except

25 as provided in subsection (c), the Director may not restrict
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1 the publication or dissemination of data from, or the re2 sults of, projects conducted or supported under this title.

3 ‘‘(c) LIMITATION ON USE OF CERTAIN INFORMA4 TION.—No information, if an establishment or person sup5 plying the information or described in it is identifiable,

6 obtained in the course of activities undertaken or sup7 ported under this title may be used for any purpose other

8 than the purpose for which it was supplied unless such

9 establishment or person has consented (as determined

10 under regulations of the Secretary) to its use for such

11 other purpose. Such information may not be published or

12 released in other form if the person who supplied the infor13 mation or who is described in it is identifiable unless such

14 person has consented (as determined under regulations of

15 the Secretary) to its publication or release in other form.

16 ‘‘(d) PENALTY.—Any person who violates subsection

17 (c) shall be subject to a civil monetary penalty of not more

18 than $10,000 for each such violation involved. Such pen19 alty shall be imposed and collected in the same manner

20 as civil money penalties under subsection (a) of section

21 1128A of the Social Security Act are imposed and col22 lected.
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1 ‘‘SEC. 925. ADDITIONAL PROVISIONS WITH RESPECT TO

2 GRANTS AND CONTRACTS.

3 ‘‘(a) FINANCIAL CONFLICTS OF INTEREST.—With

4 respect to projects for which awards of grants, cooperative

5 agreements, or contracts are authorized to be made under

6 this title, the Director shall by regulation define—

7 ‘‘(1) the specific circumstances that constitute

8 financial interests in such projects that will, or may

9 be reasonably expected to, create a bias in favor of

10 obtaining results in the projects that are consistent

11 with such interests; and

12 ‘‘(2) the actions that will be taken by the Direc13 tor in response to any such interests identified by

14 the Director.

15 ‘‘(b) REQUIREMENT OF APPLICATION.—The Director

16 may not, with respect to any program under this title au17 thorizing the provision of grants, cooperative agreements,

18 or contracts, provide any such financial assistance unless

19 an application for the assistance is submitted to the Sec20 retary and the application is in such form, is made in such

21 manner, and contains such agreements, assurances, and

22 information as the Director determines to be necessary to

23 carry out the program in involved.

24 ‘‘(c) PROVISION OF SUPPLIES AND SERVICES IN

25 LIEU OF FUNDS.—
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1 ‘‘(1) IN GENERAL.—Upon the request of an en2 tity receiving a grant, cooperative agreement, or con3 tract under this title, the Secretary may, subject to

4 paragraph (2), provide supplies, equipment, and

5 services for the purpose of aiding the entity in car6 rying out the project involved and, for such purpose,

7 may detail to the entity any officer or employee of

8 the Department of Health and Human Services.

9 ‘‘(2) CORRESPONDING REDUCTION IN FUNDS.—

10 With respect to a request described in paragraph

11 (1), the Secretary shall reduce the amount of the fi12 nancial assistance involved by an amount equal to

13 the costs of detailing personnel and the fair market

14 value of any supplies, equipment, or services pro15 vided by the Director. The Secretary shall, for the

16 payment of expenses incurred in complying with

17 such request, expend the amounts withheld.

18 ‘‘(d) APPLICABILITY OF CERTAIN PROVISIONS WITH

19 RESPECT TO CONTRACTS.—Contracts may be entered into

20 under this part without regard to sections 3648 and 3709

21 of the Revised Statutes (31 U.S.C. 529; 41 U.S.C. 5).

22 ‘‘SEC. 926. CERTAIN ADMINISTRATIVE AUTHORITIES.

23 ‘‘(a) DEPUTY DIRECTOR AND OTHER OFFICERS AND

24 EMPLOYEES.—
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1 ‘‘(1) DEPUTY DIRECTOR.—The Director may

2 appoint a deputy director for the Agency.

3 ‘‘(2) OTHER OFFICERS AND EMPLOYEES.—The

4 Director may appoint and fix the compensation of

5 such officers and employees as may be necessary to

6 carry out this title. Except as otherwise provided by

7 law, such officers and employees shall be appointed

8 in accordance with the civil service laws and their

9 compensation fixed in accordance with title 5,

10 United States Code.

11 ‘‘(b) FACILITIES.—The Secretary, in carrying out

12 this title—

13 ‘‘(1) may acquire, without regard to the Act of

14 March 3, 1877 (40 U.S.C. 34), by lease or otherwise

15 through the Director of General Services, buildings

16 or portions of buildings in the District of Columbia

17 or communities located adjacent to the District of

18 Columbia for use for a period not to exceed 10

19 years; and

20 ‘‘(2) may acquire, construct, improve, repair,

21 operate, and maintain laboratory, research, and

22 other necessary facilities and equipment, and such

23 other real or personal property (including patents)

24 as the Secretary deems necessary.
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1 ‘‘(c) PROVISION OF FINANCIAL ASSISTANCE.—The

2 Director, in carrying out this title, may make grants to

3 public and nonprofit entities and individuals, and may

4 enter into cooperative agreements or contracts with public

5 and private entities and individuals.

6 ‘‘(d) UTILIZATION OF CERTAIN PERSONNEL AND RE7 SOURCES.—

8 ‘‘(1) DEPARTMENT OF HEALTH AND HUMAN

9 SERVICES.—The Director, in carrying out this title,

10 may utilize personnel and equipment, facilities, and

11 other physical resources of the Department of

12 Health and Human Services, permit appropriate (as

13 determined by the Secretary) entities and individuals

14 to utilize the physical resources of such Department,

15 and provide technical assistance and advice.

16 ‘‘(2) OTHER AGENCIES.—The Director, in car17 rying out this title, may use, with their consent, the

18 services, equipment, personnel, information, and fa19 cilities of other Federal, State, or local public agen20 cies, or of any foreign government, with or without

21 reimbursement of such agencies.

22 ‘‘(e) CONSULTANTS.—The Secretary, in carrying out

23 this title, may secure, from time to time and for such peri24 ods as the Director deems advisable but in accordance

25 with section 3109 of title 5, United States Code, the as-
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1 sistance and advice of consultants from the United States

2 or abroad.

3 ‘‘(f) EXPERTS.—

4 ‘‘(1) IN GENERAL.—The Secretary may, in car5 rying out this title, obtain the services of not more

6 than 50 experts or consultants who have appropriate

7 scientific or professional qualifications. Such experts

8 or consultants shall be obtained in accordance with

9 section 3109 of title 5, United States Code, except

10 that the limitation in such section on the duration

11 of service shall not apply.

12 ‘‘(2) TRAVEL EXPENSES.—

13 ‘‘(A) IN GENERAL.—Experts and consult14 ants whose services are obtained under para15 graph (1) shall be paid or reimbursed for their

16 expenses associated with traveling to and from

17 their assignment location in accordance with

18 sections 5724, 5724a(a), 5724a(c), and

19 5726(C) of title 5, United States Code.

20 ‘‘(B) LIMITATION.—Expenses specified in

21 subparagraph (A) may not be allowed in con22 nection with the assignment of an expert or

23 consultant whose services are obtained under

24 paragraph (1) unless and until the expert

25 agrees in writing to complete the entire period
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1 of assignment, or 1 year, whichever is shorter,

2 unless separated or reassigned for reasons that

3 are beyond the control of the expert or consult4 ant and that are acceptable to the Secretary. If

5 the expert or consultant violates the agreement,

6 the money spent by the United States for the

7 expenses specified in subparagraph (A) is recov8 erable from the expert or consultant as a statu9 tory obligation owed to the United States. The

10 Secretary may waive in whole or in part a right

11 of recovery under this subparagraph.

12 ‘‘(g) VOLUNTARY AND UNCOMPENSATED SERV13 ICES.—The Director, in carrying out this title, may accept

14 voluntary and uncompensated services.

15 ‘‘SEC. 927. FUNDING.

16 ‘‘(a) INTENT.—To ensure that the United States’s in17 vestment in biomedical research is rapidly translated into

18 improvements in the quality of patient care, there must

19 be a corresponding investment in research on the most ef20 fective clinical and organizational strategies for use of

21 these findings in daily practice. The authorization levels

22 in subsections (b) and (c) provide for a proportionate in23 crease in healthcare research as the United State’s invest24 ment in biomedical research increases.
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1 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—For the

2 purpose of carrying out this title, there are authorized to

3 be appropriated $185,000,000 for fiscal year 2000, and

4 such sums as may be necessary for each of the fiscal years

5 2001 through 2006.

6 ‘‘(c) EVALUATIONS.—In addition to amounts avail7 able pursuant to subsection (b) for carrying out this title,

8 there shall be made available for such purpose, from the

9 amounts made available pursuant to section 241 (relating

10 to evaluations), an amount equal to 40 percent of the max11 imum amount authorized in such section 241 to be made

12 available for a fiscal year.

13 ‘‘SEC. 929. DEFINITIONS.

14 ‘‘In this title:

15 ‘‘(1) ADVISORY COUNCIL.—The term ‘Advisory

16 Council’ means the Advisory Council on Healthcare

17 Research and Quality established under section 921.

18 ‘‘(2) AGENCY.—The term ‘Agency’ means the

19 Agency for Healthcare Research and Quality.

20 ‘‘(3) DIRECTOR.—The term ‘Director’ means

21 the Director for the Agency for Healthcare Research

22 and Quality.’’.

23 SEC. 403. REFERENCES.

24 Effective upon the date of enactment of this Act, any

25 reference in law to the ‘‘Agency for Health Care Policy
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1 and Research’’ shall be deemed to be a reference to the

2 ‘‘Agency for Healthcare Research and Quality’’.

3 SEC. 404. STUDY.

4 (a) STUDY.—Not later than 30 days after the date

5 of enactment of any Act providing for a qualifying health

6 care benefit (as defined in subsection (b)), the Secretary

7 of Health and Human Services, in consultation with the

8 Agency for Healthcare Research and Quality, the National

9 Institutes of Health, and the Institute of Medicine, shall

10 conduct a study concerning such benefit that scientifically

11 evaluates—

12 (1) the safety and efficacy of the benefit, par13 ticularly the effect of the benefit on outcomes of

14 care;

15 (2) the cost, benefits and value of such benefit;

16 (3) the benefit in comparison to alternative ap17 proaches in improving care; and

18 (4) the overall impact that such benefit will

19 have on health care as measured through research.

20 (b) QUALIFYING HEALTH CARE BENEFIT.—In this

21 section, the term ‘‘qualifying health care benefit’’ means

22 a health care benefit that—

23 (1) is disease- or health condition-specific;

24 (2) requires the provision of or coverage for

25 health care items or services;
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1 (3) applies to group health plan, individual

2 health plans, or health insurance issuers under part

3 7 of subtitle B of title I of the Employee Retirement

4 Income Security Act of 1974 (29 U.S.C. 1181 et

5 seq.) or under title XXVII of the Public Health

6 Service Act (42 U.S.C. 300gg et seq.); and

7 (4) was provided under an Act (or amendment)

8 enacted on or after January 1, 1999.

9 (c) REPORTS.—Not later than 3 years after the date

10 of enactment of any Act described in subsection (a), the

11 Secretary of Health and Human Services shall prepare

12 and submit to the appropriate committees of Congress a

13 report based on the study conducted under such sub14 section with respect to the qualifying health care benefit

15 involved.

16 TITLE V—MISCELLANEOUS

17 PROVISIONS

18 SEC. 501. SENSE OF THE COMMITTEE.

19 It is the sense of the Committee on Health, Edu20 cation, Labor, and Pensions of the Senate that the Con21 gress should take measures to further the purposes of this

22 Act, including any necessary changes to the Internal Rev23 enue Code of 1986 or to other Acts to—
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1 (1) promote equity and prohibit discrimination

2 based on genetic information with respect to the

3 availability of health benefits;

4 (2) provide for the full deduction of health in5 surance costs for self-employed individuals;

6 (3) provide for the full availability of medical

7 savings accounts;

8 (4) provide for the carryover of unused benefits

9 from cafeteria plans, flexible spending arrangements,

10 and health flexible spending accounts; and

11 (5) permit contributions towards medical sav12 ings account through the Federal employees health

13 benefits program.

14 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

15 (a) SHORT TITLE.—This Act may be cited as the ‘‘Pa16 tients’ Bill of Rights Act’’.

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

18 this Act is as follows:

Sec. 1. Short title; table of contents.

TITLE I—PATIENTS’ BILL OF RIGHTS

Subtitle A—Right to Advice and Care

Sec. 101. Patient right to medical advice and care.

‘‘SUBPART C—PATIENT RIGHT TO MEDICAL ADVICE AND CARE

‘‘Sec. 721. Patient access to emergency medical care.

‘‘Sec. 722. Offering of choice of coverage options.

‘‘Sec. 723. Patient access to obstetric and gynecological care.

‘‘Sec. 724. Patient access to pediatric care.

‘‘Sec. 725. Access to specialists.

‘‘Sec. 726. Continuity of care.

‘‘Sec. 727. Protection of patient-provider communications.
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‘‘Sec. 728. Patient’s right to prescription drugs.

‘‘Sec. 729. Self-payment for behavioral health care services.

‘‘Sec. 730. Generally applicable provision.

Sec. 102. Comprehensive independent study of patient access to clinical trials and

coverage of associated routine costs.

Sec. 103. Effective date and related rules.

Subtitle B—Right to Information About Plans and Providers

Sec. 111. Information about plans.

Sec. 112. Information about providers.

Subtitle C—Right to Hold Health Plans Accountable

Sec. 121. Amendment to Employee Retirement Income Security Act of 1974.

TITLE II—GENETIC INFORMATION AND SERVICES

Sec. 201. Short title.

Sec. 202. Amendments to Employee Retirement Income Security Act of 1974.

Sec. 203. Amendments to the Public Health Service Act.

Sec. 204. Amendments to the Internal Revenue Code of 1986.

TITLE III—HEALTHCARE RESEARCH AND QUALITY

Sec. 301. Short title.

Sec. 302. Amendment to the Public Health Service Act.

‘‘TITLE IX—AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

‘‘PART A—ESTABLISHMENT AND GENERAL DUTIES

‘‘Sec. 901. Mission and duties.

‘‘Sec. 902. General authorities.

‘‘PART B—HEALTHCARE IMPROVEMENT RESEARCH

‘‘Sec. 911. Healthcare outcome improvement research.

‘‘Sec. 912. Private-public partnerships to improve organization and delivery.

‘‘Sec. 913. Information on quality and cost of care.

‘‘Sec. 914. Information systems for healthcare improvement.

‘‘Sec. 915. Research supporting primary care and access in underserved

areas.

‘‘Sec. 916. Clinical practice and technology innovation.

‘‘Sec. 917. Coordination of Federal Government quality improvement efforts.

‘‘PART C—GENERAL PROVISIONS

‘‘Sec. 921. Advisory Council for Healthcare Research and Quality.

‘‘Sec. 922. Peer review with respect to grants and contracts.

‘‘Sec. 923. Certain provisions with respect to development, collection, and

dissemination of data.

‘‘Sec. 924. Dissemination of information.

‘‘Sec. 925. Additional provisions with respect to grants and contracts.

‘‘Sec. 926. Certain administrative authorities.

‘‘Sec. 927. Funding.

‘‘Sec. 928. Definitions.

Sec. 303. References.
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TITLE IV—MISCELLANEOUS PROVISIONS

Sec. 401. Sense of the Committee.

1 TITLE I—PATIENTS’ BILL OF

2 RIGHTS

3 Subtitle A—Right to Advice and

4 Care

5 SEC. 101. PATIENT RIGHT TO MEDICAL ADVICE AND CARE.

6 (a) IN GENERAL.—Part 7 of subtitle B of title I of

7 the Employee Retirement Income Security Act of 1974 (29

8 U.S.C. 1181 et seq.) is amended—

9 (1) by redesignating subpart C as subpart D;

10 and

11 (2) by inserting after subpart B the following:

12 ‘‘Subpart C—Patient Right to Medical Advice and

13 Care

14 ‘‘SEC. 721. PATIENT ACCESS TO EMERGENCY MEDICAL

15 CARE.

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

17 plan (other than a fully insured group health plan) pro18 vides coverage for benefits consisting of emergency medical

19 care (as defined in subsection (c)), except for items or serv20 ices specifically excluded—

21 ‘‘(1) the plan shall provide coverage for benefits,

22 without requiring preauthorization, for appropriate

23 emergency medical screening examinations (within

24 the capability of the emergency facility, including an-
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1 cillary services routinely available to the emergency

2 facility) to the extent that a prudent layperson, who

3 possesses an average knowledge of health and medi4 cine, would determine such examinations to be nec5 essary to determine whether emergency medical care

6 (as so defined) is necessary; and

7 ‘‘(2) the plan shall provide coverage for benefits,

8 without requiring preauthorization, for additional

9 emergency medical care to stabilize an emergency

10 medical condition following an emergency medical

11 screening examination (if determined necessary under

12 paragraph (1)), pursuant to the definition of stabilize

13 under section 1867(e)(3) of the Social Security Act

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

15 ‘‘(b) UNIFORM COST-SHARING REQUIRED AND OUT16 OF-NETWORK CARE.—

17 ‘‘(1) UNIFORM COST-SHARING.—Nothing in this

18 section shall be construed as preventing a group

19 health plan (other than a fully insured group health

20 plan) from imposing any form of cost-sharing appli21 cable to any participant or beneficiary (including co22 insurance, copayments, deductibles, and any other

23 charges) in relation to coverage for benefits described

24 in subsection (a), if such form of cost-sharing is uni25 formly applied under such plan, with respect to simi-
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1 larly situated participants and beneficiaries, to all

2 benefits consisting of emergency medical care (as de3 fined in subsection (c)) provided to such similarly sit4 uated participants and beneficiaries under the plan.

5 ‘‘(2) OUT-OF-NETWORK CARE.—If a group health

6 plan (other than a fully insured group health plan)

7 provides any benefits with respect to emergency med8 ical care (as defined in subsection (c)), the plan shall

9 cover emergency medical care under the plan in a

10 manner so that, if such care is provided to a partici11 pant or beneficiary by a nonparticipating health care

12 provider, the participant or beneficiary is not liable

13 for amounts that exceed the amounts of liability that

14 would be incurred if the services were provided by a

15 participating provider.

16 ‘‘(c) DEFINITION OF EMERGENCY MEDICAL CARE.—In

17 this section:

18 ‘‘(1) IN GENERAL.—The term ‘emergency medical

19 care’ means, with respect to a participant or bene20 ficiary under a group health plan (other than a fully

21 insured group health plan), covered inpatient and

22 outpatient services that—

23 ‘‘(A) are furnished by any provider, includ24 ing a nonparticipating provider, that is quali25 fied to furnish such services; and
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1 ‘‘(B) are needed to evaluate or stabilize (as

2 such term is defined in section 1867(e)(3) of the

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

4 an emergency medical condition (as defined in

5 paragraph (2)).

6 ‘‘(2) EMERGENCY MEDICAL CONDITION.—The

7 term ‘emergency medical condition’ means a medical

8 condition manifesting itself by acute symptoms of suf9 ficient severity (including severe pain) such that a

10 prudent layperson, who possesses an average knowl11 edge of health and medicine, could reasonably expect

12 the absence of immediate medical attention to result

13 in—

14 ‘‘(A) placing the health of the participant or

15 beneficiary (or, with respect to a pregnant

16 woman, the health of the woman or her unborn

17 child) in serious jeopardy,

18 ‘‘(B) serious impairment to bodily func19 tions, or

20 ‘‘(C) serious dysfunction of any bodily

21 organ or part.

22 ‘‘SEC. 722. OFFERING OF CHOICE OF COVERAGE OPTIONS.

23 ‘‘(a) REQUIREMENT.—

24 ‘‘(1) OFFERING OF POINT-OF-SERVICE COVERAGE

25 OPTION.—Except as provided in paragraph (2), if a
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1 group health plan (other than a fully insured group

2 health plan) provides coverage for benefits only

3 through a defined set of participating health care pro4 fessionals, the plan shall offer the participant the op5 tion to purchase point-of-service coverage (as defined

6 in subsection (b)) for all such benefits for which cov7 erage is otherwise so limited. Such option shall be

8 made available to the participant at the time of en9 rollment under the plan and at such other times as

10 the plan offers the participant a choice of coverage op11 tions.

12 ‘‘(2) EXCEPTION IN THE CASE OF MULTIPLE

13 ISSUER OR COVERAGE OPTIONS.—Paragraph (1) shall

14 not apply with respect to a participant in a group

15 health plan (other than a fully insured group health

16 plan) if the plan offers the participant 2 or more cov17 erage options that differ significantly with respect to

18 the use of participating health care professionals or

19 the networks of such professionals that are used.

20 ‘‘(b) POINT-OF-SERVICE COVERAGE DEFINED.—In

21 this section, the term ‘point-of-service coverage’ means, with

22 respect to benefits covered under a group health plan (other

23 than a fully insured group health plan), coverage of such

24 benefits when provided by a nonparticipating health care

25 professional.
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1 ‘‘(c) SMALL EMPLOYER EXEMPTION.—

2 ‘‘(1) IN GENERAL.—This section shall not apply

3 to any group health plan (other than a fully insured

4 group health plan) of a small employer.

5 ‘‘(2) SMALL EMPLOYER.—For purposes of para6 graph (1), the term ‘small employer’ means, in con7 nection with a group health plan (other than a fully

8 insured group health plan) with respect to a calendar

9 year and a plan year, an employer who employed an

10 average of at least 2 but not more than 50 employees

11 on business days during the preceding calendar year

12 and who employs at least 2 employees on the first day

13 of the plan year. For purposes of this paragraph, the

14 provisions of subparagraph (C) of section 712(c)(1)

15 shall apply in determining employer size.

16 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec17 tion shall be construed—

18 ‘‘(1) as requiring coverage for benefits for a par19 ticular type of health care professional;

20 ‘‘(2) as requiring an employer to pay any costs

21 as a result of this section or to make equal contribu22 tions with respect to different health coverage options;

23 ‘‘(3) as preventing a group health plan (other

24 than a fully insured group health plan) from impos25 ing higher premiums or cost-sharing on a participant
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1 for the exercise of a point-of-service coverage option;

2 or

3 ‘‘(4) to require that a group health plan (other

4 than a fully insured group health plan) include cov5 erage of health care professionals that the plan ex6 cludes because of fraud, quality of care, or other simi7 lar reasons with respect to such professionals.

8 ‘‘SEC. 723. PATIENT ACCESS TO OBSTETRIC AND GYNECO9 LOGICAL CARE.

10 ‘‘(a) GENERAL RIGHTS.—

11 ‘‘(1) WAIVER OF PLAN REFERRAL REQUIRE12 MENT.—If a group health plan described in subsection

13 (b) requires a referral to obtain coverage for speciality

14 care, the plan shall waive the referral requirement in

15 the case of a female participant or beneficiary who

16 seeks coverage for routine obstetrical care or routine

17 gynecological care.

18 ‘‘(2) RELATED ROUTINE CARE.—With respect to

19 a participant or beneficiary described in paragraph

20 (1), a group health plan described in subsection (b)

21 shall treat the ordering of other routine care that is

22 related to routine obstetric or gynecologic care, by a

23 physician who specializes in obstetrics and gynecology

24 as the authorization of the primary care provider for

25 such other routine care.
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1 ‘‘(b) APPLICATION OF SECTION.—A group health plan

2 described in this subsection is a group health plan (other

3 than a fully insured group health plan), that—

4 ‘‘(1) provides coverage for routine obstetric care

5 (such as pregnancy-related services) or routine

6 gynecologic care (such as preventive women’s health

7 examinations); and

8 ‘‘(2) requires the designation by a participant or

9 beneficiary of a participating primary care provider

10 who is not a physician who specializes in obstetrics

11 or gynecology.

12 ‘‘(c) RULES OF CONSTRUCTION.—Nothing in this sec13 tion shall be construed—

14 ‘‘(1) as waiving any coverage requirement relat15 ing to medical necessity or appropriateness with re16 spect to the coverage of obstetric or gynecologic care

17 described in subsection (a);

18 ‘‘(2) to preclude the plan from requiring that the

19 physician who specializes in obstetrics or gynecology

20 notify the designated primary care provider or the

21 plan of treatment decisions; or

22 ‘‘(3) to preclude a group health plan from allow23 ing health care professionals other than physicians to

24 provide routine obstetric or routine gynecologic care.
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1 ‘‘SEC. 724. PATIENT ACCESS TO PEDIATRIC CARE.

2 ‘‘(a) IN GENERAL.—In the case of a group health plan

3 (other than a fully insured group health plan) that provides

4 coverage for routine pediatric care and that requires the

5 designation by a participant or beneficiary of a partici6 pating primary care provider, if the designated primary

7 care provider is not a physician who specializes in

8 pediatrics—

9 ‘‘(1) the plan may not require authorization or

10 referral by the primary care provider in order for a

11 participant or beneficiary to obtain coverage for rou12 tine pediatric care; and

13 ‘‘(2) the plan shall treat the ordering of other

14 routine care related to routine pediatric care by such

15 a specialist as having been authorized by the des16 ignated primary care provider.

17 ‘‘(b) RULES OF CONSTRUCTION.—Nothing in sub18 section (a) shall be construed—

19 ‘‘(1) as waiving any coverage requirement relat20 ing to medical necessity or appropriateness with re21 spect to the coverage of any pediatric care provided

22 to, or ordered for, a participant or beneficiary;

23 ‘‘(2) to preclude a group health plan from re24 quiring that a specialist described in subsection (a)

25 notify the designated primary care provider or the

26 plan of treatment decisions; or
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1 ‘‘(3) to preclude a group health plan from allow2 ing health care professionals other than physicians to

3 provide routine pediatric care.

4 ‘‘SEC. 725. ACCESS TO SPECIALISTS.

5 ‘‘(a) IN GENERAL.—A group health plan (other than

6 a fully insured group health plan) shall ensure that partici7 pants and beneficiaries have access to specialty care when

8 such care is covered under the plan. Such access may be

9 provided through contractual arrangements with specialized

10 providers outside of the network of the plan.

11 ‘‘(b) TREATMENT PLANS.—

12 ‘‘(1) IN GENERAL.—Nothing in this section shall

13 be construed to prohibit a group health plan (other

14 than a fully insured group health plan) from requir15 ing that speciality care be provided pursuant to a

16 treatment plan so long as the treatment plan is—

17 ‘‘(A) developed by the specialist, in con18 sultation with the primary care provider, and

19 the participant or beneficiary;

20 ‘‘(B) approved by the plan; and

21 ‘‘(C) in accordance with the applicable

22 quality assurance and utilization review stand23 ards of the plan.

24 ‘‘(2) NOTIFICATION.—Nothing in paragraph (1)

25 shall be construed as prohibiting a plan from requir-
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1 ing the specialist to provide the primary care pro2 vider with regular updates on the specialty care pro3 vided, as well as all other necessary medical informa4 tion.

5 ‘‘(c) REFERRALS.—Nothing in this section shall be

6 construed to prohibit a plan from requiring an authoriza7 tion by the primary care provider of the participant or ben8 eficiary in order to obtain coverage for speciality services

9 so long as such authorization is for an adequate number

10 of referrals under an approved treatment plan if such a

11 treatment plan is required by the plan.

12 ‘‘(d) SPECIALITY CARE DEFINED.—For purposes of

13 this subsection, the term ‘‘speciality care’’ means, with re14 spect to a condition, care and treatment provided by a

15 health care practitioner, facility, or center (such as a center

16 of excellence) that has adequate expertise (including age-ap17 propriate expertise) through appropriate training and ex18 perience.

19 ‘‘SEC. 726. CONTINUITY OF CARE.

20 ‘‘(a) IN GENERAL.—

21 ‘‘(1) TERMINATION OF PROVIDER.—If a contract

22 between a group health plan (other than a fully in23 sured group health plan) and a health care provider

24 is terminated (as defined in paragraph (2)), or bene25 fits or coverage provided by a health care provider are
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1 terminated because of a change in the terms of pro2 vider participation in such group health plan, and

3 an individual who is a participant or beneficiary in

4 the plan is undergoing a course of treatment from the

5 provider at the time of such termination, the plan

6 shall—

7 ‘‘(A) notify the individual on a timely basis

8 of such termination;

9 ‘‘(B) provide the individual with an oppor10 tunity to notify the plan of a need for transi11 tional care; and

12 ‘‘(C) in the case of termination described in

13 paragraph (2), (3), or (4) of subsection (b), and

14 subject to subsection (c), permit the individual to

15 continue or be covered with respect to the course

16 of treatment with the provider’s consent during

17 a transitional period (as provided under sub18 section (b)).

19 ‘‘(2) TERMINATED.—In this section, the term

20 ‘terminated’ includes, with respect to a contract, the

21 expiration or nonrenewal of the contract by the group

22 health plan, but does not include a termination of the

23 contract by the plan for failure to meet applicable

24 quality standards or for fraud.
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1 ‘‘(3) CONTRACTS.—For purposes of this section,

2 the term ‘contract between a group health plan (other

3 than a fully insured group health plan) and a health

4 care provider’ shall include a contract between such

5 a plan and an organized network of providers.

6 ‘‘(b) TRANSITIONAL PERIOD.—

7 ‘‘(1) GENERAL RULE.—Except as provided in

8 paragraph (3), the transitional period under this sub9 section shall permit the participant or beneficiary to

10 extend the coverage involved for up to 90 days from

11 the date of the notice described in subsection (a)(1)(A)

12 of the provider’s termination.

13 ‘‘(2) INSTITUTIONAL CARE.—Subject to para14 graph (1), the transitional period under this sub15 section for institutional or inpatient care from a pro16 vider shall extend until the discharge or termination

17 of the period of institutionalization and also shall in18 clude institutional care provided within a reasonable

19 time of the date of termination of the provider status

20 if the care was scheduled before the date of the an21 nouncement of the termination of the provider status

22 under subsection (a)(1)(A) or if the individual on

23 such date was on an established waiting list or other24 wise scheduled to have such care.
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1 ‘‘(3) PREGNANCY.—Notwithstanding paragraph

2 (1), if—

3 ‘‘(A) a participant or beneficiary has en4 tered the second trimester of pregnancy at the

5 time of a provider’s termination of participa6 tion; and

7 ‘‘(B) the provider was treating the preg8 nancy before the date of the termination;

9 the transitional period under this subsection with re10 spect to provider’s treatment of the pregnancy shall

11 extend through the provision of post-partum care di12 rectly related to the delivery.

13 ‘‘(4) TERMINAL ILLNESS.—Subject to paragraph

14 (1), if—

15 ‘‘(A) a participant or beneficiary was deter16 mined to be terminally ill (as determined under

17 section 1861(dd)(3)(A) of the Social Security

18 Act) prior to a provider’s termination of partici19 pation; and

20 ‘‘(B) the provider was treating the terminal

21 illness before the date of termination;

22 the transitional period under this subsection shall be

23 for care directly related to the treatment of the ter24 minal illness.
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1 ‘‘(c) PERMISSIBLE TERMS AND CONDITIONS.—A group

2 health plan (other than a fully insured group health plan)

3 may condition coverage of continued treatment by a pro4 vider under subsection (a)(1)(C) upon the provider agreeing

5 to the following terms and conditions:

6 ‘‘(1) The provider agrees to accept reimburse7 ment from the plan and individual involved (with re8 spect to cost-sharing) at the rates applicable prior to

9 the start of the transitional period as payment in full

10 (or at the rates applicable under the replacement plan

11 after the date of the termination of the contract with

12 the group health plan) and not to impose cost-sharing

13 with respect to the individual in an amount that

14 would exceed the cost-sharing that could have been

15 imposed if the contract referred to in subsection (a)(1)

16 had not been terminated.

17 ‘‘(2) The provider agrees to adhere to the quality

18 assurance standards of the plan responsible for pay19 ment under paragraph (1) and to provide to such

20 plan necessary medical information related to the

21 care provided.

22 ‘‘(3) The provider agrees otherwise to adhere to

23 such plan’s policies and procedures, including proce24 dures regarding referrals and obtaining prior author-
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1 ization and providing services pursuant to a treat2 ment plan (if any) approved by the plan.

3 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec4 tion shall be construed to require the coverage of benefits

5 which would not have been covered if the provider involved

6 remained a participating provider.

7 ‘‘(e) DEFINITION.—In this section, the term ‘health

8 care provider’ or ‘provider’ means—

9 ‘‘(1) any individual who is engaged in the deliv10 ery of health care services in a State and who is re11 quired by State law or regulation to be licensed or

12 certified by the State to engage in the delivery of such

13 services in the State; and

14 ‘‘(2) any entity that is engaged in the delivery

15 of health care services in a State and that, if it is re16 quired by State law or regulation to be licensed or

17 certified by the State to engage in the delivery of such

18 services in the State, is so licensed.

19 ‘‘SEC. 727. PROTECTION OF PATIENT-PROVIDER COMMU20 NICATIONS.

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

22 health plan (other than a fully insured group health plan

23 and in relation to a participant or beneficiary) shall not

24 prohibit or otherwise restrict a health care professional from

25 advising such a participant or beneficiary who is a patient
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1 of the professional about the health status of the participant

2 or beneficiary or medical care or treatment for the condition

3 or disease of the participant or beneficiary, regardless of

4 whether coverage for such care or treatment are provided

5 under the contract, if the professional is acting within the

6 lawful scope of practice.

7 ‘‘(b) RULE OF CONSTRUCTION.—Nothing in this sec8 tion shall be construed as requiring a group health plan

9 (other than a fully insured group health plan) to provide

10 specific benefits under the terms of such plan.

11 ‘‘SEC. 728. PATIENT’S RIGHT TO PRESCRIPTION DRUGS.

12 ‘‘To the extent that a group health plan (other than

13 a fully insured group health plan) provides coverage for

14 benefits with respect to prescription drugs, and limits such

15 coverage to drugs included in a formulary, the plan shall—

16 ‘‘(1) ensure the participation of physicians and

17 pharmacists in developing and reviewing such for18 mulary; and

19 ‘‘(2) in accordance with the applicable quality

20 assurance and utilization review standards of the

21 plan, provide for exceptions from the formulary limi22 tation when a non-formulary alternative is medically

23 necessary and appropriate.
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1 ‘‘SEC. 729. SELF-PAYMENT FOR BEHAVIORAL HEALTH CARE

2 SERVICES.

3 ‘‘(a) IN GENERAL.—A group health plan (other than

4 a fully insured group health plan) may not—

5 ‘‘(1) prohibit or otherwise discourage a partici6 pant or beneficiary from self-paying for behavioral

7 health care services once the plan has denied coverage

8 for such services; or

9 ‘‘(2) terminate a health care provider because

10 such provider permits participants or beneficiaries to

11 self-pay for behavioral health care services—

12 ‘‘(A) that are not otherwise covered under

13 the plan; or

14 ‘‘(B) for which the group health plan pro15 vides limited coverage, to the extent that the

16 group health plan denies coverage of the services.

17 ‘‘(b) RULE OF CONSTRUCTION.—Nothing in subsection

18 (a)(2)(B) shall be construed as prohibiting a group health

19 plan from terminating a contract with a health care pro20 vider for failure to meet applicable quality standards or

21 for fraud.

22 ‘‘SEC. 730. GENERALLY APPLICABLE PROVISION.

23 ‘‘In the case of a group health plan that provides bene24 fits under 2 or more coverage options, the requirements of

25 this subpart, other than section 722, shall apply separately

26 with respect to each coverage option.’’.
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1 (b) DEFINITION.—Section 733(a) of the Employee Re2 tirement Income Security Act of 1974 (42 U.S.C. 1191(a))

3 is amended by adding at the end the following:

4 ‘‘(3) FULLY INSURED GROUP HEALTH PLAN.—

5 The term ‘fully insured group health plan’ means a

6 group health plan where benefits under the plan are

7 provided pursuant to the terms of an arrangement be8 tween a group health plan and a health insurance

9 issuer and are guaranteed by the health insurance

10 issuer under a contract or policy of insurance.’’.

11 (c) CONFORMING AMENDMENT.—The table of contents

12 in section 1 of such Act is amended—

13 (1) in the item relating to subpart C, by striking

14 ‘‘Subpart C’’ and inserting ‘‘Subpart D’’; and

15 (2) by adding at the end of the items relating to

16 subpart B of part 7 of subtitle B of title I of such Act

17 the following new items:

‘‘SUBPART C—PATIENT RIGHT TO MEDICAL ADVICE AND CARE

‘‘Sec. 721. Patient access to emergency medical care.

‘‘Sec. 722. Offering of choice of coverage options.

‘‘Sec. 723. Patient access to obstetric and gynecological care.

‘‘Sec. 724. Patient access to pediatric care.

‘‘Sec. 725. Access to specialists.

‘‘Sec. 726. Continuity of care.

‘‘Sec. 727. Protection of patient-provider communications.

‘‘Sec. 728. Patient’s right to prescription drugs.

‘‘Sec. 729. Self-payment for behavioral health care services.

‘‘Sec. 730. Generally applicable provisions.’’.
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1 SEC. 102. COMPREHENSIVE INDEPENDENT STUDY OF PA2 TIENT ACCESS TO CLINICAL TRIALS AND COV3 ERAGE OF ASSOCIATED ROUTINE COSTS.

4 (a) STUDY BY THE INSTITUTE OF MEDICINE.—Not

5 later than 30 days after the date of enactment of this Act,

6 the Secretary of Health and Human Services (in this sec7 tion referred to as the ‘‘Secretary’’) shall enter into a con8 tract with the Institute of Medicine to conduct a comprehen9 sive study of patient access to clinical trials and the cov10 erage of routine patient care costs by private health plans

11 and insurers.

12 (b) MATTERS TO BE ASSESSED.—The study shall as13 sess the following:

14 (1) The factors that hinder patient participation

15 in clinical trials, including health plan and insur16 ance policies and practices.

17 (2) The ability of health plans and investigators

18 to distinguish between routine patient care costs and

19 costs associated with clinical trials.

20 (3) The potential impact of health plan coverage

21 of routine costs associated with clinical trials on

22 health care premiums.

23 (c) REPORT.—

24 (1) IN GENERAL.—Not later than 12 months

25 after the date of the execution of the contract referred

26 to in subsection (a), the Institute of Medicine shall
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1 submit a report on the study conducted pursuant to

2 that contract to the Committee on Health, Education,

3 Labor and Pensions of the Senate.

4 (2) MATTERS INCLUDED.—The report submitted

5 under paragraph (1) shall set forth the findings, con6 clusions, and recommendations of the Institute of

7 Medicine for—

8 (A) increasing patient participation in

9 clinical trials;

10 (B) encouraging collaboration between the

11 public and private sectors; and

12 (C) improving analysis of determining rou13 tine costs associated with the conduct of clinical

14 trials.

15 (3) COPY TO SECRETARY.—Concurrent with the

16 submission of the report under paragraph (1), the In17 stitute of Medicine shall transmit a copy of the report

18 to the Secretary.

19 (d) FUNDING.—Out of funds appropriated to the De20 partment of Health and Human Services for fiscal year

21 2000, the Secretary shall provide for such funding as the

22 Secretary determines is necessary in order to carry out the

23 study and report by the Institute of Medicine under this

24 section.
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1 SEC. 103. EFFECTIVE DATE AND RELATED RULES.

2 (a) IN GENERAL.—The amendments made by this sub3 title shall apply with respect to plan years beginning on

4 or after January 1 of the second calendar year following

5 the date of the enactment of this Act. The Secretary shall

6 issue all regulations necessary to carry out the amendments

7 made by this section before the effective date thereof.

8 (b) LIMITATION ON ENFORCEMENT ACTIONS.—No en9 forcement action shall be taken, pursuant to the amend10 ments made by this subtitle, against a group health plan

11 with respect to a violation of a requirement imposed by such

12 amendments before the date of issuance of regulations issued

13 in connection with such requirement, if the plan has sought

14 to comply in good faith with such requirement.

15 Subtitle B—Right to Information

16 About Plans and Providers

17 SEC. 111. INFORMATION ABOUT PLANS.

18 (a) EMPLOYEE RETIREMENT INCOME SECURITY ACT

19 OF 1974.—

20 (1) IN GENERAL.—Subpart B of part 7 of sub21 title B of title I of the Employee Retirement Income

22 Security Act of 1974, as amended by the Omnibus

23 Consolidated and Emergency Supplemental Appro24 priations Act, 1999 (Public Law 105–277), is amend25 ed by adding at the end the following:
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1 ‘‘SEC. 714. HEALTH PLAN COMPARATIVE INFORMATION.

2 ‘‘(a) REQUIREMENT.—

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

4 health insurance issuer that provides coverage in con5 nection with group health insurance coverage, shall,

6 not later than 12 months after the date of enactment

7 of this section, and at least annually thereafter, pro8 vide for the disclosure, in a clear and accurate form

9 to each participant and each beneficiary who does not

10 reside at the same address as the participant, or upon

11 request to an individual eligible for coverage under

12 the plan, of the information described in subsection

13 (b).

14 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in this

15 section shall be construed to prevent a plan or issuer

16 from entering into any agreement under which the

17 issuer agrees to assume responsibility for compliance

18 with the requirements of this section and the plan is

19 released from liability for such compliance.

20 ‘‘(3) PROVISION OF INFORMATION.—Information

21 shall be provided to participants and beneficiaries

22 under this section at the address maintained by the

23 plan or issuer with respect to such participants or

24 beneficiaries.

25 ‘‘(b) REQUIRED INFORMATION.—The informational

26 materials to be distributed under this section shall include
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1 for each package option available under a group health plan

2 the following:

3 ‘‘(1) A description of the covered items and serv4 ices under each such plan and any in- and out-of-net5 work features of each such plan, including a sum6 mary description of the specific exclusions from cov7 erage under the plan.

8 ‘‘(2) A description of any cost-sharing, including

9 premiums, deductibles, coinsurance, and copayment

10 amounts, for which the participant or beneficiary will

11 be responsible, including any annual or lifetime lim12 its on benefits, for each such plan.

13 ‘‘(3) A description of any optional supplemental

14 benefits offered by each such plan and the terms and

15 conditions (including premiums or cost-sharing) for

16 such supplemental coverage.

17 ‘‘(4) A description of any restrictions on pay18 ments for services furnished to a participant or bene19 ficiary by a health care professional that is not a

20 participating professional and the liability of the

21 participant or beneficiary for additional payments

22 for these services.

23 ‘‘(5) A description of the service area of each

24 such plan, including the provision of any out-of-area

25 coverage.
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1 ‘‘(6) A description of the extent to which partici2 pants and beneficiaries may select the primary care

3 provider of their choice, including providers both

4 within the network and outside the network of each

5 such plan (if the plan permits out-of-network serv6 ices).

7 ‘‘(7) A description of the procedures for advance

8 directives and organ donation decisions if the plan

9 maintains such procedures.

10 ‘‘(8) A description of the requirements and pro11 cedures to be used to obtain preauthorization for

12 health services (including telephone numbers and

13 mailing addresses), including referrals for specialty

14 care.

15 ‘‘(9) A description of the definition of medical

16 necessity used in making coverage determinations by

17 each such plan.

18 ‘‘(10) A summary of the rules and methods for

19 appealing coverage decisions and filing grievances

20 (including telephone numbers and mailing addresses),

21 as well as other available remedies.

22 ‘‘(11) A summary description of any provisions

23 for obtaining off-formulary medications if the plan

24 utilizes a defined formulary for providing specific

25 prescription medications.
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1 ‘‘(12) A summary of the rules for access to emer2 gency room care. Also, any available educational ma3 terial regarding proper use of emergency services.

4 ‘‘(13) A description of whether or not coverage is

5 provided for experimental treatments, investigational

6 treatments, or clinical trials and the circumstances

7 under which access to such treatments or trials is

8 made available.

9 ‘‘(14) A description of the specific preventative

10 services covered under the plan if such services are

11 covered.

12 ‘‘(15) A statement regarding—

13 ‘‘(A) the manner in which a participant or

14 beneficiary may access an obstetrician, gyne15 cologist, or pediatrician in accordance with sec16 tion 723 or 724; and

17 ‘‘(B) the manner in which a participant or

18 beneficiary obtains continuity of care as pro19 vided for in section 726.

20 ‘‘(16) A statement that the following informa21 tion, and instructions on obtaining such information

22 (including telephone numbers and, if available, Inter23 net websites), shall be made available upon request:

24 ‘‘(A) The names, addresses, telephone num25 bers, and State licensure status of the plan’s par-
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1 ticipating health care professionals and partici2 pating health care facilities, and, if available,

3 the education, training, speciality qualifications

4 or certifications of such professionals.

5 ‘‘(B) A summary description of the methods

6 used for compensating participating health care

7 professionals, such as capitation, fee-for-service,

8 salary, or a combination thereof. The require9 ment of this subparagraph shall not be construed

10 as requiring plans to provide information con11 cerning proprietary payment methodology.

12 ‘‘(C) A summary description of the methods

13 used for compensating health care facilities, in14 cluding per diem, fee-for-service, capitation, bun15 dled payments, or a combination thereof. The re16 quirement of this subparagraph shall not be con17 strued as requiring plans to provide information

18 concerning proprietary payment methodology.

19 ‘‘(D) A summary description of the proce20 dures used for utilization review.

21 ‘‘(E) The list of the specific prescription

22 medications included in the formulary of the

23 plan, if the plan uses a defined formulary.

24 ‘‘(F) A description of the specific exclusions

25 from coverage under the plan.
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1 ‘‘(G) Any available information related to

2 the availability of translation or interpretation

3 services for non-English speakers and people

4 with communication disabilities, including the

5 availability of audio tapes or information in

6 Braille.

7 ‘‘(H) Any information that is made public

8 by accrediting organizations in the process of ac9 creditation if the plan is accredited, or any ad10 ditional quality indicators that the plan makes

11 available.

12 ‘‘(c) MANNER OF DISTRIBUTION.—The information de13 scribed in this section shall be distributed in an accessible

14 format that is understandable to an average plan partici15 pant or beneficiary.

16 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec17 tion may be construed to prohibit a group health plan, or

18 health insurance issuer in connection with group health in19 surance coverage, from distributing any other additional

20 information determined by the plan or issuer to be impor21 tant or necessary in assisting participants and beneficiaries

22 or upon request potential participants and beneficiaries in

23 the selection of a health plan or from providing information

24 under subsection (b)(15) as part of the required informa25 tion.
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1 ‘‘(e) 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 part 1, to re5 duce duplication with respect to any information that is

6 required to be provided under any such requirements.

7 ‘‘(f) HEALTH CARE PROFESSIONAL.—In this section,

8 the term ‘health care professional’ means a physician (as

9 defined in section 1861(r) of the Social Security Act) or

10 other health care professional if coverage for the profes11 sional’s services is provided under the health plan involved

12 for the services of the professional. Such term includes a

13 podiatrist, optometrist, chiropractor, psychologist, dentist,

14 physician assistant, physical or occupational therapist and

15 therapy assistant, speech-language pathologist, audiologist,

16 registered or licensed practical nurse (including nurse prac17 titioner, clinical nurse specialist, certified registered nurse

18 anesthetist, and certified nurse-midwife), licensed certified

19 social worker, registered respiratory therapist, and certified

20 respiratory therapy technician.’’.

21 (2) CONFORMING AMENDMENTS.—

22 (A) Section 732(a) of the Employee Retire23 ment Income Security Act of 1974 (29 U.S.C.

24 1191a(a)) is amended by striking ‘‘section 711,

25 and inserting ‘‘sections 711 and 714’’.
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1 (B) The table of contents in section 1 of the

2 Employee Retirement Income Security Act of

3 1974 (29 U.S.C. 1001) is amended by inserting

4 after the item relating to section 713, the fol5 lowing:

‘‘Sec. 714. Health plan comparative information.’’.

6 (b) INTERNAL REVENUE CODE OF 1986.—Subchapter

7 B of chapter 100 of the Internal Revenue Code of 1986 is

8 amended—

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

10 item relating to section 9812 the following new item:

‘‘Sec. 9813. Health plan comparative information.’’; and

11 (2) by inserting after section 9812 the following:

12 ‘‘SEC. 9813. HEALTH PLAN COMPARATIVE INFORMATION.

13 ‘‘(a) REQUIREMENT.—

14 ‘‘(1) IN GENERAL.—A group health plan shall,

15 not later than 12 months after the date of enactment

16 of this section, and at least annually thereafter, pro17 vide for the disclosure, in a clear and accurate form

18 to each participant and each beneficiary who does not

19 reside at the same address as the participant, or upon

20 request to an individual eligible for coverage under

21 the plan, of the information described in subsection

22 (b).

23 ‘‘(2) RULES OF CONSTRUCTION.—Nothing in this

24 section shall be construed to prevent a plan from en-
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1 tering into any agreement under which a health in2 surance issuer agrees to assume responsibility for

3 compliance with the requirements of this section and

4 the plan is released from liability for such compli5 ance.

6 ‘‘(3) PROVISION OF INFORMATION.—Information

7 shall be provided to participants and beneficiaries

8 under this section at the address maintained by the

9 plan with respect to such participants or bene10 ficiaries.

11 ‘‘(b) REQUIRED INFORMATION.—The informational

12 materials to be distributed under this section shall include

13 for each package option available under a group health plan

14 the following:

15 ‘‘(1) A description of the covered items and serv16 ices under each such plan and any in- and out-of-net17 work features of each such plan, including a sum18 mary description of the specific exclusions from cov19 erage under the plan.

20 ‘‘(2) A description of any cost-sharing, including

21 premiums, deductibles, coinsurance, and copayment

22 amounts, for which the participant or beneficiary will

23 be responsible, including any annual or lifetime lim24 its on benefits, for each such plan.
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1 ‘‘(3) A description of any optional supplemental

2 benefits offered by each such plan and the terms and

3 conditions (including premiums or cost-sharing) for

4 such supplemental coverage.

5 ‘‘(4) A description of any restrictions on pay6 ments for services furnished to a participant or bene7 ficiary by a health care professional that is not a

8 participating professional and the liability of the

9 participant or beneficiary for additional payments

10 for these services.

11 ‘‘(5) A description of the service area of each

12 such plan, including the provision of any out-of-area

13 coverage.

14 ‘‘(6) A description of the extent to which partici15 pants and beneficiaries may select the primary care

16 provider of their choice, including providers both

17 within the network and outside the network of each

18 such plan (if the plan permits out-of-network serv19 ices).

20 ‘‘(7) A description of the procedures for advance

21 directives and organ donation decisions if the plan

22 maintains such procedures.

23 ‘‘(8) A description of the requirements and pro24 cedures to be used to obtain preauthorization for

25 health services (including telephone numbers and
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1 mailing addresses), including referrals for specialty

2 care.

3 ‘‘(9) A description of the definition of medical

4 necessity used in making coverage determinations by

5 each such plan.

6 ‘‘(10) A summary of the rules and methods for

7 appealing coverage decisions and filing grievances

8 (including telephone numbers and mailing addresses),

9 as well as other available remedies.

10 ‘‘(11) A summary description of any provisions

11 for obtaining off-formulary medications if the plan

12 utilizes a defined formulary for providing specific

13 prescription medications.

14 ‘‘(12) A summary of the rules for access to emer15 gency room care. Also, any available educational ma16 terial regarding proper use of emergency services.

17 ‘‘(13) A description of whether or not coverage is

18 provided for experimental treatments, investigational

19 treatments, or clinical trials and the circumstances

20 under which access to such treatments or trials is

21 made available.

22 ‘‘(14) A description of the specific preventative

23 services covered under the plan if such services are

24 covered.

25 ‘‘(15) A statement regarding—
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1 ‘‘(A) the manner in which a participant or

2 beneficiary may access an obstetrician, gyne3 cologist, or pediatrician in accordance with sec4 tion 723 or 724; and

5 ‘‘(B) the manner in which a participant or

6 beneficiary obtains continuity of care as pro7 vided for in section 726.

8 ‘‘(16) A statement that the following informa9 tion, and instructions on obtaining such information

10 (including telephone numbers and, if available, Inter11 net websites), shall be made available upon request:

12 ‘‘(A) The names, addresses, telephone num13 bers, and State licensure status of the plan’s par14 ticipating health care professionals and partici15 pating health care facilities, and, if available,

16 the education, training, speciality qualifications

17 or certifications of such professionals.

18 ‘‘(B) A summary description of the methods

19 used for compensating participating health care

20 professionals, such as capitation, fee-for-service,

21 salary, or a combination thereof. The require22 ment of this subparagraph shall not be construed

23 as requiring plans to provide information con24 cerning proprietary payment methodology.
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1 ‘‘(C) A summary description of the methods

2 used for compensating health care facilities, in3 cluding per diem, fee-for-service, capitation, bun4 dled payments, or a combination thereof. The re5 quirement of this subparagraph shall not be con6 strued as requiring plans to provide information

7 concerning proprietary payment methodology.

8 ‘‘(D) A summary description of the proce9 dures used for utilization review.

10 ‘‘(E) The list of the specific prescription

11 medications included in the formulary of the

12 plan, if the plan uses a defined formulary.

13 ‘‘(F) A description of the specific exclusions

14 from coverage under the plan.

15 ‘‘(G) Any available information related to

16 the availability of translation or interpretation

17 services for non-English speakers and people

18 with communication disabilities, including the

19 availability of audio tapes or information in

20 Braille.

21 ‘‘(H) Any information that is made public

22 by accrediting organizations in the process of ac23 creditation if the plan is accredited, or any ad24 ditional quality indicators that the plan makes

25 available.
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1 ‘‘(c) MANNER OF DISTRIBUTION.—The information de2 scribed in this section shall be distributed in an accessible

3 format that is understandable to an average plan partici4 pant or beneficiary.

5 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec6 tion may be construed to prohibit a group health plan from

7 distributing any other additional information determined

8 by the plan to be important or necessary in assisting par9 ticipants and beneficiaries or upon request potential par10 ticipants and beneficiaries in the selection of a health plan

11 or from providing information under subsection (b)(15) as

12 part of the required information.

13 ‘‘(e) HEALTH CARE PROFESSIONAL.—In this section,

14 the term ‘health care professional’ means a physician (as

15 defined in section 1861(r) of the Social Security Act) or

16 other health care professional if coverage for the profes17 sional’s services is provided under the health plan involved

18 for the services of the professional. Such term includes a

19 podiatrist, optometrist, chiropractor, psychologist, dentist,

20 physician assistant, physical or occupational therapist and

21 therapy assistant, speech-language pathologist, audiologist,

22 registered or licensed practical nurse (including nurse prac23 titioner, clinical nurse specialist, certified registered nurse

24 anesthetist, and certified nurse-midwife), licensed certified
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1 social worker, registered respiratory therapist, and certified

2 respiratory therapy technician.’’.

3 SEC. 112. INFORMATION ABOUT PROVIDERS.

4 (a) STUDY.—The Secretary of Health and Human

5 Services shall enter into a contract with the Institute of

6 Medicine for the conduct of a study, and the submission

7 to the Secretary of a report, that includes—

8 (1) an analysis of information concerning health

9 care professionals that is currently available to pa10 tients, consumers, States, and professional societies,

11 nationally and on a State-by-State basis, including

12 patient preferences with respect to information about

13 such professionals and their competencies;

14 (2) an evaluation of the legal and other barriers

15 to the sharing of information concerning health care

16 professionals; and

17 (3) recommendations for the disclosure of infor18 mation on health care professionals, including the

19 competencies and professional qualifications of such

20 practitioners, to better facilitate patient choice, qual21 ity improvement, and market competition.

22 (b) REPORT.—Not later than 18 months after the date

23 of enactment of this Act, the Secretary of Health and

24 Human Services shall forward to the appropriate commit-
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1 tees of Congress a copy of the report and study conducted

2 under subsection (a).

3 Subtitle C—Right to Hold Health

4 Plans Accountable

5 SEC. 121. AMENDMENT TO EMPLOYEE RETIREMENT IN6 COME SECURITY ACT OF 1974.

7 (a) IN GENERAL.—Section 503 of the Employee Re8 tirement Income Security Act of 1974 (29 U.S.C. 1133) is

9 amended to read as follows:

10 ‘‘SEC. 503. CLAIMS PROCEDURE, COVERAGE DETERMINA11 TION, GRIEVANCES AND APPEALS.

12 ‘‘(a) CLAIMS PROCEDURE.—In accordance with regu13 lations of the Secretary, every employee benefit plan shall—

14 ‘‘(1) provide adequate notice in writing to any

15 participant or beneficiary whose claim for benefits

16 under the plan has been denied, setting forth the spe17 cific reasons for such denial, written in a manner cal18 culated to be understood by the participant; and

19 ‘‘(2) afford a reasonable opportunity to any par20 ticipant whose claim for benefits has been denied for

21 a full and fair review by the appropriate named fidu22 ciary of the decision denying the claim.

23 ‘‘(b) COVERAGE DETERMINATIONS UNDER GROUP

24 HEALTH PLANS.—

25 ‘‘(1) PROCEDURES.—
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1 ‘‘(A) IN GENERAL.—A group health plan or

2 health insurance issuer conducting utilization re3 view shall ensure that procedures are in place

4 for—

5 ‘‘(i) making determinations regarding

6 whether a participant or beneficiary is eli7 gible to receive a payment or coverage for

8 health services under the plan or coverage

9 involved and any cost-sharing amount that

10 the participant or beneficiary is required to

11 pay with respect to such service;

12 ‘‘(ii) notifying a covered participant or

13 beneficiary (or the authorized representative

14 of such participant or beneficiary) and the

15 treating health care professionals involved

16 regarding determinations made under the

17 plan or issuer and any additional pay18 ments that the participant or beneficiary

19 may be required to make with respect to

20 such service; and

21 ‘‘(iii) responding to requests, either

22 written or oral, for coverage determinations

23 or for internal appeals from a participant

24 or beneficiary (or the authorized representa25 tive of such participant or beneficiary) or
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1 the treating health care professional with

2 the consent of the participant or bene3 ficiary.

4 ‘‘(B) ORAL REQUESTS.—With respect to an

5 oral request described in subparagraph (A)(iii),

6 a group health plan or health insurance issuer

7 may require that the requesting individual pro8 vide written evidence of such request.

9 ‘‘(2) TIMELINE FOR MAKING DETERMINATIONS.—

10 ‘‘(A) ROUTINE DETERMINATION.—A group

11 health plan or a health insurance issuer shall

12 maintain procedures to ensure that prior author13 ization determinations concerning the provision

14 of non-emergency items or services are made

15 within 30 days from the date on which the re16 quest for a determination is submitted, except

17 that such period may be extended where certain

18 circumstances exist that are determined by the

19 Secretary to be beyond control of the plan or

20 issuer.

21 ‘‘(B) EXPEDITED DETERMINATION.—

22 ‘‘(i) IN GENERAL.—A prior authoriza23 tion determination under this subsection

24 shall be made within 72 hours, in accord25 ance with the medical exigencies of the case,
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1 after a request is received by the plan or

2 issuer under clause (ii) or (iii).

3 ‘‘(ii) REQUEST BY PARTICIPANT OR

4 BENEFICIARY.—A plan or issuer shall

5 maintain procedures for expediting a prior

6 authorization determination under this sub7 section upon the request of a participant or

8 beneficiary if, based on such a request, the

9 plan or issuer determines that the normal

10 time for making such a determination could

11 seriously jeopardize the life or health of the

12 participant or beneficiary.

13 ‘‘(iii) DOCUMENTATION BY HEALTH

14 CARE PROFESSIONAL.—A plan or issuer

15 shall maintain procedures for expediting a

16 prior authorization determination under

17 this subsection if the request involved indi18 cates that the treating health care profes19 sional has reasonably documented, based on

20 the medical exigencies, that a determination

21 under the procedures described in subpara22 graph (A) could seriously jeopardize the life

23 or health of the participant or beneficiary.

24 ‘‘(C) CONCURRENT DETERMINATIONS.—A

25 plan or issuer shall maintain procedures to cer-
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•S 326 RS

1 tify or deny coverage of an extended stay or ad2 ditional services.

3 ‘‘(D) RETROSPECTIVE DETERMINATION.—A

4 plan or issuer shall maintain procedures to en5 sure that, with respect to the retrospective review

6 of a determination made under paragraph (1),

7 the determination shall be made within 30 work8 ing days of the date on which the plan or issuer

9 receives necessary information.

10 ‘‘(3) NOTICE OF DETERMINATIONS.—

11 ‘‘(A) ROUTINE DETERMINATION.—With re12 spect to a coverage determination of a plan or

13 issuer under paragraph (2)(A), the plan or

14 issuer shall issue notice of such determination to

15 the participant or beneficiary (or the authorized

16 representative of the participant or beneficiary)

17 and, consistent with the medical exigencies of the

18 case, to the treating health care professional in19 volved not later than 2 working days after the

20 date on which the determination is made.

21 ‘‘(B) EXPEDITED DETERMINATION.—With

22 respect to a coverage determination of a plan or

23 issuer under paragraph (2)(B), the plan or

24 issuer shall issue notice of such determination to

25 the participant or beneficiary (or the authorized
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1 representative of the participant or beneficiary),

2 and consistent with the medical exigencies of the

3 case, to the treating health care professional in4 volved within the 72 hour period described in

5 paragraph (2)(B).

6 ‘‘(C) CONCURRENT REVIEWS.—With respect

7 to the determination under a plan or issuer

8 under paragraph (2)(C) to certify or deny cov9 erage of an extended stay or additional services,

10 the plan or issuer shall issue notice of such deter11 mination to the treating health care professional

12 and to the participant or beneficiary involved

13 (or the authorized representative of the partici14 pant or beneficiary) within 1 working day of the

15 determination.

16 ‘‘(D) RETROSPECTIVE REVIEWS.—With re17 spect to the retrospective review under a plan or

18 issuer of a determination made under paragraph

19 (2)(D), the plan or issuer shall issue written no20 tice of an approval or disapproval of a deter21 mination under this subparagraph to the partic22 ipant or beneficiary (or the authorized represent23 ative of the participant or beneficiary) and

24 health care provider involved within 5 working
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1 days of the date on which such determination is

2 made.

3 ‘‘(E) REQUIREMENTS OF NOTICE OF AD4 VERSE COVERAGE DETERMINATIONS.—A written

5 notice of an adverse coverage determination

6 under this subsection, or of an expedited adverse

7 coverage determination under paragraph (2)(B),

8 shall be provided to the participant or bene9 ficiary (or the authorized representative of the

10 participant or beneficiary) and treating health

11 care professional (if any) involved and shall

12 include—

13 ‘‘(i) the reasons for the determination

14 (including the clinical or scientific-evidence

15 based rationale used in making the deter16 mination) written in a manner to be under17 standable to the average participant or ben18 eficiary;

19 ‘‘(ii) the procedures for obtaining addi20 tional information concerning the deter21 mination; and

22 ‘‘(iii) notification of the right to ap23 peal the determination and instructions on

24 how to initiate an appeal in accordance

25 with subsection (d).
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1 ‘‘(c) GRIEVANCES.—A group health plan or a health

2 insurance issuer shall have written procedures for address3 ing grievances between the plan or issuer offering health

4 insurance coverage in connection with a group health plan

5 and a participant or beneficiary. Determinations under

6 such procedures shall be non-appealable.

7 ‘‘(d) INTERNAL APPEAL OF COVERAGE DETERMINA8 TIONS.—

9 ‘‘(1) RIGHT TO APPEAL.—

10 ‘‘(A) IN GENERAL.—A participant or bene11 ficiary (or the authorized representative of the

12 participant or beneficiary) or the treating health

13 care professional with the consent of the partici14 pant or beneficiary (or the authorized represent15 ative of the participant or beneficiary), may ap16 peal any adverse coverage determination under

17 subsection (b) under the procedures described in

18 this subsection.

19 ‘‘(B) TIME FOR APPEAL.—A plan or issuer

20 shall ensure that a participant or beneficiary

21 has a period of not less than 180 days beginning

22 on the date of an adverse coverage determination

23 under subsection (b) in which to appeal such de24 termination under this subsection.
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1 ‘‘(C) FAILURE TO ACT.—The failure of a

2 plan or issuer to issue a determination under

3 subsection (b) within the applicable timeline es4 tablished for such a determination under such

5 subsection shall be treated as an adverse coverage

6 determination for purposes of proceeding to in7 ternal review under this subsection.

8 ‘‘(2) RECORDS.—A group health plan and a

9 health insurance issuer shall maintain written

10 records, for at least 6 years, with respect to any ap11 peal under this subsection for purposes of internal

12 quality assurance and improvement. Nothing in the

13 preceding sentence shall be construed as preventing a

14 plan and issuer from entering into an agreement

15 under which the issuer agrees to assume responsibility

16 for compliance with the requirements of this section

17 and the plan is released from liability for such com18 pliance.

19 ‘‘(3) ROUTINE DETERMINATIONS.—A group

20 health plan or a health insurance issuer shall com21 plete the consideration of an appeal of an adverse

22 routine determination under this subsection not later

23 than 30 working days after the date on which a re24 quest for such appeal is received.

25 ‘‘(4) EXPEDITED DETERMINATION.—
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1 ‘‘(A) IN GENERAL.—An expedited deter2 mination with respect to an appeal under this

3 subsection shall be made in accordance with the

4 medical exigencies of the case, but in no case

5 more than 72 hours after the request for such ap6 peal is received by the plan or issuer under sub7 paragraph (B) or (C).

8 ‘‘(B) REQUEST BY PARTICIPANT OR BENE9 FICIARY.—A plan or issuer shall maintain pro10 cedures for expediting a prior authorization de11 termination under this subsection upon the re12 quest of a participant or beneficiary if, based on

13 such a request, the plan or issuer determines that

14 the normal time for making such a determina15 tion could seriously jeopardize the life or health

16 of the participant or beneficiary.

17 ‘‘(C) DOCUMENTATION BY HEALTH CARE

18 PROFESSIONAL.—A plan or issuer shall main19 tain procedures for expediting a prior authoriza20 tion determination under this subsection if the

21 request involved indicates that the treating

22 health care professional has reasonably docu23 mented, based on the medical exigencies of the

24 case that a determination under the procedures

25 described in paragraph (2) could seriously jeop-
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1 ardize the life or health of the participant or

2 beneficiary.

3 ‘‘(5) CONDUCT OF REVIEW.—A review of an ad4 verse coverage determination under this subsection

5 shall be conducted by an individual with appropriate

6 expertise who was not directly involved in the initial

7 determination.

8 ‘‘(6) LACK OF MEDICAL NECESSITY.—A review of

9 an appeal under this subsection relating to a deter10 mination to deny coverage based on a lack of medical

11 necessity and appropriateness, or based on an experi12 mental or investigational treatment, shall be made

13 only by a physician with appropriate expertise, in14 cluding age-appropriate expertise, who was not in15 volved in the initial determination.

16 ‘‘(7) NOTICE.—

17 ‘‘(A) IN GENERAL.—Written notice of a de18 termination made under an internal review

19 process shall be issued to the participant or bene20 ficiary (or the authorized representative of the

21 participant or beneficiary) and the treating

22 health care professional not later than 2 working

23 days after the completion of the review (or with24 in the 72-hour period referred to in paragraph

25 (4) if applicable).
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1 ‘‘(B) ADVERSE COVERAGE DETERMINA2 TIONS.—With respect to an adverse coverage de3 termination made under this subsection, the no4 tice described in subparagraph (A) shall

5 include—

6 ‘‘(i) the reasons for the determination

7 (including the clinical or scientific-evidence

8 based rationale used in making the deter9 mination) written in a manner to be under10 standable to the average participant or ben11 eficiary;

12 ‘‘(ii) the procedures for obtaining addi13 tional information concerning the deter14 mination; and

15 ‘‘(iii) notification of the right to an

16 independent external review under sub17 section (e) and instructions on how to ini18 tiate such a review.

19 ‘‘(e) INDEPENDENT EXTERNAL REVIEW.—

20 ‘‘(1) ACCESS TO REVIEW.—

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

22 a health insurance issuer offering health insur23 ance coverage in connection with a group health

24 plan shall have written procedures to permit a

25 participant or beneficiary (or the authorized rep-
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1 resentative of the participant or beneficiary) ac2 cess to an independent external review with re3 spect to an adverse coverage determination con4 cerning a particular item or service (including a

5 circumstance treated as an adverse coverage de6 termination under subparagraph (B)) where—

7 ‘‘(i) the particular item or service

8 involved—

9 ‘‘(I)(aa) would be a covered ben10 efit, when medically necessary and ap11 propriate under the terms and condi12 tions of the plan, and the item or serv13 ice has been determined not to be medi14 cally necessary and appropriate under

15 the internal appeals process required

16 under subsection (d) or there has been

17 a failure to issue a coverage determina18 tion as described in subparagraph (B);

19 and

20 ‘‘(bb)(AA) the amount of such

21 item or service involved exceeds a sig22 nificant financial threshold; or

23 ‘‘(BB) there is a significant risk

24 of placing the life or health of the par25 ticipant or beneficiary in jeopardy; or
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1 ‘‘(II) would be a covered benefit,

2 when not considered experimental or

3 investigational under the terms and

4 conditions of the plan, and the item or

5 service has been determined to be ex6 perimental or investigational under the

7 internal appeals process required

8 under subsection (d) or there has been

9 a failure to issue a coverage determina10 tion as described in subparagraph (B);

11 and

12 ‘‘(ii) the participant or beneficiary has

13 completed the internal appeals process

14 under subsection (d) with respect to such de15 termination.

16 ‘‘(B) FAILURE TO ACT.—The failure of a

17 plan or issuer to issue a coverage determination

18 under subsection (d)(6) within the applicable

19 timeline established for such a determination

20 under such subsection shall be treated as an ad21 verse coverage determination for purposes of pro22 ceeding to independent external review under

23 this subsection.

24 ‘‘(2) INITIATION OF THE INDEPENDENT EXTER25 NAL REVIEW PROCESS.—
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1 ‘‘(A) FILING OF REQUEST.—A participant

2 or beneficiary (or the authorized representative

3 of the participant or beneficiary) who desires to

4 have an independent external review conducted

5 under this subsection shall file a written request

6 for such a review with the plan or issuer in7 volved not later than 30 working days after the

8 receipt of a final denial of a claim under sub9 section (d). Any such request shall include the

10 consent of the participant or beneficiary (or the

11 authorized representative of the participant or

12 beneficiary) for the release of medical informa13 tion and records to independent external review14 ers regarding the participant or beneficiary.

15 ‘‘(B) INFORMATION AND NOTICE.—Not later

16 than 5 working days after the receipt of a re17 quest under subparagraph (A), or earlier in ac18 cordance with the medical exigencies of the case,

19 the plan or issuer involved shall select an exter20 nal appeals entity under paragraph (3)(A) that

21 shall be responsible for designating an inde22 pendent external reviewer under paragraph

23 (3)(B).

24 ‘‘(C) PROVISION OF INFORMATION.—The

25 plan or issuer involved shall forward necessary
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•S 326 RS

1 information (including medical records, any rel2 evant review criteria, the clinical rationale con3 sistent with the terms and conditions of the con4 tract between the plan or issuer and the partici5 pant or beneficiary for the coverage denial, and

6 evidence of the coverage of the participant or

7 beneficiary) to the independent external reviewer

8 selected under paragraph (3)(B).

9 ‘‘(D) NOTIFICATION.—The plan or issuer

10 involved shall send a written notification to the

11 participant or beneficiary (or the authorized rep12 resentative of the participant or beneficiary) and

13 the plan administrator, indicating that an inde14 pendent external review has been initiated.

15 ‘‘(3) CONDUCT OF INDEPENDENT EXTERNAL RE16 VIEW.—

17 ‘‘(A) DESIGNATION OF EXTERNAL APPEALS

18 ENTITY BY PLAN OR ISSUER.—

19 ‘‘(i) IN GENERAL.—A plan or issuer

20 that receives a request for an independent

21 external review under paragraph (2)(A)

22 shall designate a qualified entity described

23 in clause (ii), in a manner designed to en24 sure that the entity so designated will make
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1 a decision in an unbiased manner, to serve

2 as the external appeals entity.

3 ‘‘(ii) QUALIFIED ENTITIES.—A quali4 fied entity shall be—

5 ‘‘(I) an independent external re6 view entity licensed or credentialed by

7 a State;

8 ‘‘(II) a State agency established

9 for the purpose of conducting inde10 pendent external reviews;

11 ‘‘(III) any entity under contract

12 with the Federal Government to pro13 vide independent external review serv14 ices;

15 ‘‘(IV) any entity accredited as an

16 independent external review entity by

17 an accrediting body recognized by the

18 Secretary for such purpose; or

19 ‘‘(V) any other entity meeting cri20 teria established by the Secretary for

21 purposes of this subparagraph.

22 ‘‘(B) DESIGNATION OF INDEPENDENT EX23 TERNAL REVIEWER BY EXTERNAL APPEALS ENTI24 TY.—The external appeals entity designated

25 under subparagraph (A) shall, not later than 30
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1 days after the date on which such entity is des2 ignated under subparagraph (A), or earlier in

3 accordance with the medical exigencies of the

4 case, designate one or more individuals to serve

5 as independent external reviewers with respect to

6 a request received under paragraph (2)(A). Such

7 reviewers shall be independent medical experts

8 who shall—

9 ‘‘(i) be appropriately credentialed or

10 licensed in any State to deliver health care

11 services;

12 ‘‘(ii) not have any material, profes13 sional, familial, or financial affiliation

14 with the case under review, the participant

15 or beneficiary involved, the treating health

16 care professional, the institution where the

17 treatment would take place, or the manufac18 turer of any drug, device, procedure, or

19 other therapy proposed for the participant

20 or beneficiary whose treatment is under re21 view;

22 ‘‘(iii) have expertise (including age-ap23 propriate expertise) in the diagnosis or

24 treatment under review and, when reason25 ably available, be of the same specialty as
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1 the physician treating the participant or

2 beneficiary or recommending or prescribing

3 the treatment in question;

4 ‘‘(iv) receive only reasonable and cus5 tomary compensation from the group health

6 plan or health insurance issuer in connec7 tion with the independent external review

8 that is not contingent on the decision ren9 dered by the reviewer; and

10 ‘‘(v) not be held liable for decisions re11 garding medical determinations (but may

12 be held liable for actions that are arbitrary

13 and capricious).

14 ‘‘(4) STANDARD OF REVIEW.—

15 ‘‘(A) IN GENERAL.—An independent exter16 nal reviewer shall—

17 ‘‘(i) make an independent determina18 tion based on the valid, relevant, scientific

19 and clinical evidence to determine the med20 ical necessity, appropriateness, experi21 mental or investigational nature of the pro22 posed treatment; and

23 ‘‘(ii) take into consideration appro24 priate and available information, including

25 any evidence-based decision making or clin-
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1 ical practice guidelines used by the group

2 health plan or health insurance issuer;

3 timely evidence or information submitted by

4 the plan, issuer, patient or patient’s physi5 cian; the patient’s medical record; expert

6 consensus; and medical literature as defined

7 in section 556(5) of the Federal Food, Drug,

8 and Cosmetic Act.

9 ‘‘(B) NOTICE.—The plan or issuer involved

10 shall ensure that the participant or beneficiary

11 receives notice, within 30 days after the deter12 mination of the independent medical expert, re13 garding the actions of the plan or issuer with re14 spect to the determination of such expert under

15 the independent external review.

16 ‘‘(5) TIMEFRAME FOR REVIEW.—

17 ‘‘(A) IN GENERAL.—The independent exter18 nal reviewer shall complete a review of an ad19 verse coverage determination in accordance with

20 the medical exigencies of the case.

21 ‘‘(B) LIMITATION.—Notwithstanding sub22 paragraph (A), a review described in such sub23 paragraph shall be completed not later than 30

24 working days after the later of—
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1 ‘‘(i) the date on which such reviewer is

2 designated; or

3 ‘‘(ii) the date on which all information

4 necessary to completing such review is re5 ceived.

6 ‘‘(6) BINDING DETERMINATION.—The determina7 tion of an independent external reviewer under this

8 subsection shall be binding upon the plan or issuer if

9 the provisions of this subsection or the procedures im10 plemented under such provisions were complied with

11 by the independent external reviewer.

12 ‘‘(7) STUDY.—Not later than 2 years after the

13 date of enactment of this section, the General Ac14 counting Office shall conduct a study of a statistically

15 appropriate sample of completed independent external

16 reviews. Such study shall include an assessment of the

17 process involved during an independent external re18 view and the basis of decisionmaking by the inde19 pendent external reviewer. The results of such study

20 shall be submitted to the appropriate committees of

21 Congress.

22 ‘‘(8) EFFECT ON CERTAIN PROVISIONS.—Nothing

23 in this section shall be construed as affecting or modi24 fying section 514 of this Act with respect to a group

25 health plan.
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1 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec2 tion shall be construed to prohibit a plan administrator or

3 plan fiduciary or health plan medical director from request4 ing an independent external review by an independent ex5 ternal reviewer without first completing the internal review

6 process.

7 ‘‘(g) DEFINITIONS.—In this section:

8 ‘‘(1) ADVERSE COVERAGE DETERMINATION.—The

9 term ‘adverse coverage determination’ means a cov10 erage determination under the plan which results in

11 a denial of coverage or reimbursement.

12 ‘‘(2) COVERAGE DETERMINATION.—The term

13 ‘coverage determination’ means with respect to items

14 and services for which coverage may be provided

15 under a health plan, a determination of whether or

16 not such items and services are covered or reimburs17 able under the coverage and terms of the contract.

18 ‘‘(3) GRIEVANCE.—The term ‘grievance’ means

19 any complaint made by a participant or beneficiary

20 that does not involve a coverage determination.

21 ‘‘(4) GROUP HEALTH PLAN.—The term ‘group

22 health plan’ shall have the meaning given such term

23 in section 733(a). In applying this paragraph, ex24 cepted benefits described in section 733(c) shall not be

25 treated as benefits consisting of medical care.
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1 ‘‘(5) HEALTH INSURANCE COVERAGE.—The term

2 ‘health insurance coverage’ has the meaning given

3 such term in section 733(b)(1). In applying this

4 paragraph, excepted benefits described in section

5 733(c) shall not be treated as benefits consisting of

6 medical care.

7 ‘‘(6) HEALTH INSURANCE ISSUER.—The term

8 ‘health insurance issuer’ has the meaning given such

9 term in section 733(b)(2).

10 ‘‘(7) PRIOR AUTHORIZATION DETERMINATION.—

11 The term ‘prior authorization determination’ means a

12 coverage determination prior to the provision of the

13 items and services as a condition of coverage of the

14 items and services under the coverage.

15 ‘‘(8) TREATING HEALTH CARE PROFESSIONAL.—

16 The term ‘treating health care professional’ with re17 spect to a group health plan, health insurance issuer

18 or provider sponsored organization means a physi19 cian (medical doctor or doctor of osteopathy) or other

20 health care practitioner who is acting within the

21 scope of his or her State licensure or certification for

22 the delivery of health care services and who is pri23 marily responsible for delivering those services to the

24 participant or beneficiary.
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1 ‘‘(9) UTILIZATION REVIEW.—The term ‘utiliza2 tion review’ with respect to a group health plan or

3 health insurance coverage means a set of formal tech4 niques designed to monitor the use of, or evaluate the

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

7 Techniques may include ambulatory review, prospec8 tive review, second opinion, certification, concurrent

9 review, case management, discharge planning or ret10 rospective review.’’

11 (b) ENFORCEMENT.—Section 502(c)(1) of the Em12 ployee Retirement Income Security Act of 1974 (29 U.S.C.

13 1132(c)(1)) is amended by inserting after ‘‘or section

14 101(e)(1)’’ the following: ‘‘, or fails to comply with a cov15 erage determination as required under section 503(e)(6),’’.

16 (c) CONFORMING AMENDMENT.—The table of contents

17 in section 1 of the Employee Retirement Income Security

18 Act of 1974 is amended by striking the item relating to

19 section 503 and inserting the following new item:

‘‘Sec. 503. Claims procedures, coverage determination, grievances and appeals.’’.

20 (d) EFFECTIVE DATE.—The amendments made by this

21 section shall apply with respect to plan years beginning on

22 or after 1 year after the date of enactment of this Act. The

23 Secretary shall issue all regulations necessary to carry out

24 the amendments made by this section before the effective

25 date thereof.
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1 TITLE II—GENETIC

2 INFORMATION AND SERVICES

3 SEC. 201. SHORT TITLE.

4 This title may be cited as the ‘‘Genetic Information

5 Nondiscrimination in Health Insurance Act of 1999’’.

6 SEC. 202. AMENDMENTS TO EMPLOYEE RETIREMENT IN7 COME SECURITY ACT OF 1974.

8 (a) PROHIBITION OF HEALTH DISCRIMINATION ON

9 THE BASIS OF GENETIC INFORMATION OR GENETIC SERV10 ICES.—

11 (1) NO ENROLLMENT RESTRICTION FOR GENETIC

12 SERVICES.—Section 702(a)(1)(F) of the Employee Re13 tirement Income Security Act of 1974 (29 U.S.C.

14 1182(a)(1)(F)) is amended by inserting before the pe15 riod the following: ‘‘(including information about a

16 request for or receipt of genetic services)’’.

17 (2) NO DISCRIMINATION IN GROUP PREMIUMS

18 BASED ON PREDICTIVE GENETIC INFORMATION.—Sub19 part B of part 7 of subtitle B of title I of the Em20 ployee Retirement Income Security Act of 1974, as

21 amended by section 111(a), is further amended by

22 adding at the end the following:
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1 ‘‘SEC. 715. PROHIBITING PREMIUM DISCRIMINATION

2 AGAINST GROUPS ON THE BASIS OF PRE3 DICTIVE GENETIC INFORMATION.

4 ‘‘A group health plan, or a health insurance issuer of5 fering group health insurance coverage in connection with

6 a group health plan, shall not adjust premium or contribu7 tion amounts for a group on the basis of predictive genetic

8 information concerning any individual (including a de9 pendent) or family member of the individual (including in10 formation about a request for or receipt of genetic serv11 ices).’’.

12 (3) CONFORMING AMENDMENTS.—

13 (A) IN GENERAL.—Section 702(b) of the

14 Employee Retirement Income Security Act of

15 1974 (29 U.S.C. 1182(b)) is amended by adding

16 at the end the following:

17 ‘‘(3) REFERENCE TO RELATED PROVISION.—For

18 a provision prohibiting the adjustment of premium or

19 contribution amounts for a group under a group

20 health plan on the basis of predictive genetic informa21 tion (including information about a request for or re22 ceipt of genetic services), see section 715.’’.

23 (B) TABLE OF CONTENTS.—The table of

24 contents in section 1 of the Employee Retirement

25 Income Security Act of 1974, as amended by sec26 tion 111(a), is further amended by inserting
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1 after the item relating to section 714 the fol2 lowing new item:

‘‘Sec. 715. Prohibiting premium discrimination against groups on the basis of

predictive genetic information.’’.

3 (b) LIMITATION ON COLLECTION OF PREDICTIVE GE4 NETIC INFORMATION.—Section 702 of the Employee Retire5 ment Income Security Act of 1974 (29 U.S.C. 1182) is

6 amended by adding at the end the following:

7 ‘‘(c) COLLECTION OF PREDICTIVE GENETIC INFORMA8 TION.—

9 ‘‘(1) LIMITATION ON REQUESTING OR REQUIRING

10 PREDICTIVE GENETIC INFORMATION.—Except as pro11 vided in paragraph (2), a group health plan, or a

12 health insurance issuer offering health insurance cov13 erage in connection with a group health plan, shall

14 not request or require predictive genetic information

15 concerning any individual (including a dependent) or

16 family member of the individual (including informa17 tion about a request for or receipt of genetic services).

18 ‘‘(2) INFORMATION NEEDED FOR DIAGNOSIS,

19 TREATMENT, OR PAYMENT.—

20 ‘‘(A) IN GENERAL.—Notwithstanding para21 graph (1), a group health plan, or a health in22 surance issuer offering health insurance coverage

23 in connection with a group health plan, that

24 provides health care items and services to an in-
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1 dividual or dependent may request (but may not

2 require) that such individual or dependent dis3 close, or authorize the collection or disclosure of,

4 predictive genetic information for purposes of di5 agnosis, treatment, or payment relating to the

6 provision of health care items and services to

7 such individual or dependent.

8 ‘‘(B) NOTICE OF CONFIDENTIALITY PRAC9 TICES AND DESCRIPTION OF SAFEGUARDS.—As a

10 part of a request under subparagraph (A), the

11 group health plan, or a health insurance issuer

12 offering health insurance coverage in connection

13 with a group health plan, shall provide to the in14 dividual or dependent a description of the proce15 dures in place to safeguard the confidentiality,

16 as described in subsection (d), of such predictive

17 genetic information.

18 ‘‘(d) CONFIDENTIALITY WITH RESPECT TO PRE19 DICTIVE GENETIC INFORMATION.—

20 ‘‘(1) NOTICE OF CONFIDENTIALITY PRACTICES.—

21 ‘‘(A) PREPARATION OF WRITTEN NOTICE.—

22 A group health plan, or a health insurance

23 issuer offering health insurance coverage in con24 nection with a group health plan, shall post or

25 provide, in writing and in a clear and con-
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•S 326 RS

1 spicuous manner, notice of the plan or issuer’s

2 confidentiality practices, that shall include—

3 ‘‘(i) a description of an individual’s

4 rights with respect to predictive genetic in5 formation;

6 ‘‘(ii) the procedures established by the

7 plan or issuer for the exercise of the individ8 ual’s rights; and

9 ‘‘(iii) the right to obtain a copy of the

10 notice of the confidentiality practices re11 quired under this subsection.

12 ‘‘(B) MODEL NOTICE.—The Secretary, in

13 consultation with the National Committee on

14 Vital and Health Statistics and the National As15 sociation of Insurance Commissioners, and after

16 notice and opportunity for public comment, shall

17 develop and disseminate model notices of con18 fidentiality practices. Use of the model notice

19 shall serve as a defense against claims of receiv20 ing inappropriate notice.

21 ‘‘(2) ESTABLISHMENT OF SAFEGUARDS.—A

22 group health plan, or a health insurance issuer offer23 ing health insurance coverage in connection with a

24 group health plan, shall establish and maintain ap25 propriate administrative, technical, and physical
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1 safeguards to protect the confidentiality, security, ac2 curacy, and integrity of predictive genetic informa3 tion created, received, obtained, maintained, used,

4 transmitted, or disposed of by such plan or issuer.’’.

5 (c) DEFINITIONS.—Section 733(d) of the Employee Re6 tirement Income Security Act of 1974 (29 U.S.C. 1191b(d))

7 is amended by adding at the end the following:

8 ‘‘(5) FAMILY MEMBER.—The term ‘family mem9 ber’ means with respect to an individual—

10 ‘‘(A) the spouse of the individual;

11 ‘‘(B) a dependent child of the individual,

12 including a child who is born to or placed for

13 adoption with the individual; and

14 ‘‘(C) all other individuals related by blood

15 to the individual or the spouse or child described

16 in subparagraph (A) or (B).

17 ‘‘(6) GENETIC INFORMATION.—The term ‘genetic

18 information’ means information about genes, gene

19 products, or inherited characteristics that may derive

20 from an individual or a family member (including

21 information about a request for or receipt of genetic

22 services).

23 ‘‘(7) GENETIC SERVICES.—The term ‘genetic

24 services’ means health services provided to obtain, as25 sess, or interpret genetic information for diagnostic
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1 and therapeutic purposes, and for genetic education

2 and counseling.

3 ‘‘(8) PREDICTIVE GENETIC INFORMATION.—

4 ‘‘(A) IN GENERAL.—The term ‘predictive ge5 netic information’ means, in the absence of

6 symptoms, clinical signs, or a diagnosis of the

7 condition related to such information—

8 ‘‘(i) information about an individual’s

9 genetic tests;

10 ‘‘(ii) information about genetic tests of

11 family members of the individual; or

12 ‘‘(iii) information about the occurrence

13 of a disease or disorder in family members.

14 ‘‘(B) EXCEPTIONS.—The term ‘predictive

15 genetic information’ shall not include—

16 ‘‘(i) information about the sex or age of

17 the individual;

18 ‘‘(ii) information derived from phys19 ical tests, such as the chemical, blood, or

20 urine analyses of the individual including

21 cholesterol tests; and

22 ‘‘(iii) information about physical

23 exams of the individual.

24 ‘‘(9) GENETIC TEST.—The term ‘genetic test’

25 means the analysis of human DNA, RNA, chro-
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1 mosomes, proteins, and certain metabolites, including

2 analysis of genotypes, mutations, phenotypes, or

3 karyotypes, for the purpose of predicting risk of dis4 ease in asymptomatic or undiagnosed individuals.

5 Such term does not include physical tests, such as the

6 chemical, blood, or urine analyses of the individual

7 including cholesterol tests, and physical exams of the

8 individual, in order to detect symptoms, clinical

9 signs, or a diagnosis of disease.’’.

10 (d) EFFECTIVE DATE.—Except as provided in this sec11 tion, this section and the amendments made by this section

12 shall apply with respect to group health plans for plan

13 years beginning 1 year after the date of the enactment of

14 this Act.

15 SEC. 203. AMENDMENTS TO THE PUBLIC HEALTH SERVICE

16 ACT.

17 (a) AMENDMENTS RELATING TO THE GROUP MAR18 KET.—

19 (1) PROHIBITION OF HEALTH DISCRIMINATION

20 ON THE BASIS OF GENETIC INFORMATION IN THE

21 GROUP MARKET.—

22 (A) NO ENROLLMENT RESTRICTION FOR GE23 NETIC SERVICES.—Section 2702(a)(1)(F) of the

24 Public Health Service Act (42 U.S.C. 300gg–

25 1(a)(1)(F)) is amended by inserting before the
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1 period the following: ‘‘(including information

2 about a request for or receipt of genetic serv3 ices)’’.

4 (B) NO DISCRIMINATION IN PREMIUMS

5 BASED ON PREDICTIVE GENETIC INFORMATION.—

6 Subpart 2 of part A of title XXVII of the Public

7 Health Service Act, as amended by the Omnibus

8 Consolidated and Emergency Supplemental Ap9 propriations Act, 1999 (Public Law 105–277), is

10 amended by adding at the end the following new

11 section:

12 ‘‘SEC. 2707. PROHIBITING PREMIUM DISCRIMINATION

13 AGAINST GROUPS ON THE BASIS OF PRE14 DICTIVE GENETIC INFORMATION IN THE

15 GROUP MARKET.

16 ‘‘A group health plan, or a health insurance issuer of17 fering group health insurance coverage in connection with

18 a group health plan shall not adjust premium or contribu19 tion amounts for a group on the basis of predictive genetic

20 information concerning any individual (including a de21 pendent) or family member of the individual (including in22 formation about a request for or receipt of genetic serv23 ices).’’.

24 (C) CONFORMING AMENDMENT.—Section

25 2702(b) of the Public Health Service Act (42
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•S 326 RS

1 U.S.C. 300gg–1(b)) is amended by adding at the

2 end the following:

3 ‘‘(3) REFERENCE TO RELATED PROVISION.—For

4 a provision prohibiting the adjustment of premium or

5 contribution amounts for a group under a group

6 health plan on the basis of predictive genetic informa7 tion (including information about a request for or re8 ceipt of genetic services), see section 2707.’’.

9 (D) LIMITATION ON COLLECTION AND DIS10 CLOSURE OF PREDICTIVE GENETIC INFORMA11 TION.—Section 2702 of the Public Health Service

12 Act (42 U.S.C. 300gg–1) is amended by adding

13 at the end the following:

14 ‘‘(c) COLLECTION OF PREDICTIVE GENETIC INFORMA15 TION.—

16 ‘‘(1) LIMITATION ON REQUESTING OR REQUIRING

17 PREDICTIVE GENETIC INFORMATION.—Except as pro18 vided in paragraph (2), a group health plan, or a

19 health insurance issuer offering health insurance cov20 erage in connection with a group health plan, shall

21 not request or require predictive genetic information

22 concerning any individual (including a dependent) or

23 a family member of the individual (including infor24 mation about a request for or receipt of genetic serv25 ices).
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1 ‘‘(2) INFORMATION NEEDED FOR DIAGNOSIS,

2 TREATMENT, OR PAYMENT.—

3 ‘‘(A) IN GENERAL.—Notwithstanding para4 graph (1), a group health plan, or a health in5 surance issuer offering health insurance coverage

6 in connection with a group health plan, that

7 provides health care items and services to an in8 dividual or dependent may request (but may not

9 require) that such individual or dependent dis10 close, or authorize the collection or disclosure of,

11 predictive genetic information for purposes of di12 agnosis, treatment, or payment relating to the

13 provision of health care items and services to

14 such individual or dependent.

15 ‘‘(B) NOTICE OF CONFIDENTIALITY PRAC16 TICES AND DESCRIPTION OF SAFEGUARDS.—As a

17 part of a request under subparagraph (A), the

18 group health plan, or a health insurance issuer

19 offering health insurance coverage in connection

20 with a group health plan, shall provide to the in21 dividual or dependent a description of the proce22 dures in place to safeguard the confidentiality,

23 as described in subsection (d), of such predictive

24 genetic information.
196

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1 ‘‘(d) CONFIDENTIALITY WITH RESPECT TO PRE2 DICTIVE GENETIC INFORMATION.—

3 ‘‘(1) NOTICE OF CONFIDENTIALITY PRACTICES.—

4 ‘‘(A) PREPARATION OF WRITTEN NOTICE.—

5 A group health plan, or a health insurance

6 issuer offering health insurance coverage in con7 nection with a group health plan, shall post or

8 provide, in writing and in a clear and con9 spicuous manner, notice of the plan or issuer’s

10 confidentiality practices, that shall include—

11 ‘‘(i) a description of an individual’s

12 rights with respect to predictive genetic in13 formation;

14 ‘‘(ii) the procedures established by the

15 plan or issuer for the exercise of the individ16 ual’s rights; and

17 ‘‘(iii) the right to obtain a copy of the

18 notice of the confidentiality practices re19 quired under this subsection.

20 ‘‘(B) MODEL NOTICE.—The Secretary, in

21 consultation with the National Committee on

22 Vital and Health Statistics and the National As23 sociation of Insurance Commissioners, and after

24 notice and opportunity for public comment, shall

25 develop and disseminate model notices of con-
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1 fidentiality practices. Use of the model notice

2 shall serve as a defense against claims of receiv3 ing inappropriate notice.

4 ‘‘(2) ESTABLISHMENT OF SAFEGUARDS.—A

5 group health plan, or a health insurance issuer offer6 ing health insurance coverage in connection with a

7 group health plan, shall establish and maintain ap8 propriate administrative, technical, and physical

9 safeguards to protect the confidentiality, security, ac10 curacy, and integrity of predictive genetic informa11 tion created, received, obtained, maintained, used,

12 transmitted, or disposed of by such plan or issuer.’’.

13 (2) DEFINITIONS.—Section 2791(d) of the Public

14 Health Service Act (42 U.S.C. 300gg–91(d)) is

15 amended by adding at the end the following:

16 ‘‘(15) FAMILY MEMBER.—The term ‘family mem17 ber’ means, with respect to an individual—

18 ‘‘(A) the spouse of the individual;

19 ‘‘(B) a dependent child of the individual,

20 including a child who is born to or placed for

21 adoption with the individual; and

22 ‘‘(C) all other individuals related by blood

23 to the individual or the spouse or child described

24 in subparagraph (A) or (B).
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1 ‘‘(16) GENETIC INFORMATION.—The term ‘ge2 netic information’ means information about genes,

3 gene products, or inherited characteristics that may

4 derive from an individual or a family member (in5 cluding information about a request for or receipt of

6 genetic services).

7 ‘‘(17) GENETIC SERVICES.—The term ‘genetic

8 services’ means health services provided to obtain, as9 sess, or interpret genetic information for diagnostic

10 and therapeutic purposes, and for genetic education

11 and counseling.

12 ‘‘(18) PREDICTIVE GENETIC INFORMATION.—

13 ‘‘(A) IN GENERAL.—The term ‘predictive ge14 netic information’ means, in the absence of

15 symptoms, clinical signs, or a diagnosis of the

16 condition related to such information—

17 ‘‘(i) information about an individual’s

18 genetic tests;

19 ‘‘(ii) information about genetic tests of

20 family members of the individual; or

21 ‘‘(iii) information about the occurrence

22 of a disease or disorder in family members.

23 ‘‘(B) EXCEPTIONS.—The term ‘predictive

24 genetic information’ shall not include—
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1 ‘‘(i) information about the sex or age of

2 the individual;

3 ‘‘(ii) information derived from phys4 ical tests, such as the chemical, blood, or

5 urine analyses of the individual including

6 cholesterol tests; and

7 ‘‘(iii) information about physical

8 exams of the individual.

9 ‘‘(19) GENETIC TEST.—The term ‘genetic test’

10 means the analysis of human DNA, RNA, chro11 mosomes, proteins, and certain metabolites, including

12 analysis of genotypes, mutations, phenotypes, or

13 karyotypes, for the purpose of predicting risk of dis14 ease in asymptomatic or undiagnosed individuals.

15 Such term does not include physical tests, such as the

16 chemical, blood, or urine analyses of the individual

17 including cholesterol tests, and physical exams of the

18 individual, in order to detect symptoms, clinical

19 signs, or a diagnosis of disease.’’.

20 (b) AMENDMENT RELATING TO THE INDIVIDUAL MAR21 KET.—The first subpart 3 of part B of title XXVII of the

22 Public Health Service Act (42 U.S.C. 300gg–51 et seq.) (re23 lating to other requirements), as amended by the Omnibus

24 Consolidated and Emergency Supplemental Appropriations

25 Act, 1999 (Public Law 105-277) is amended—
200

•S 326 RS

1 (1) by redesignating such subpart as subpart 2;

2 and

3 (2) by adding at the end the following:

4 ‘‘SEC. 2753. PROHIBITION OF HEALTH DISCRIMINATION ON

5 THE BASIS OF PREDICTIVE GENETIC INFOR6 MATION.

7 ‘‘(a) PROHIBITION ON PREDICTIVE GENETIC INFORMA8 TION AS A CONDITION OF ELIGIBILITY.—A health insurance

9 issuer offering health insurance coverage in the individual

10 market may not use predictive genetic information as a

11 condition of eligibility of an individual to enroll in indi12 vidual health insurance coverage (including information

13 about a request for or receipt of genetic services).

14 ‘‘(b) PROHIBITION ON PREDICTIVE GENETIC INFORMA15 TION IN SETTING PREMIUM RATES.—A health insurance

16 issuer offering health insurance coverage in the individual

17 market shall not adjust premium rates for individuals on

18 the basis of predictive genetic information concerning such

19 an individual (including a dependent) or a family member

20 of the individual (including information about a request

21 for or receipt of genetic services).

22 ‘‘(c) COLLECTION OF PREDICTIVE GENETIC INFORMA23 TION.—

24 ‘‘(1) LIMITATION ON REQUESTING OR REQUIRING

25 PREDICTIVE GENETIC INFORMATION.—Except as pro-
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1 vided in paragraph (2), a health insurance issuer of2 fering health insurance coverage in the individual

3 market shall not request or require predictive genetic

4 information concerning any individual (including a

5 dependent) or a family member of the individual (in6 cluding information about a request for or receipt of

7 genetic services).

8 ‘‘(2) INFORMATION NEEDED FOR DIAGNOSIS,

9 TREATMENT, OR PAYMENT.—

10 ‘‘(A) IN GENERAL.—Notwithstanding para11 graph (1), a health insurance issuer offering

12 health insurance coverage in the individual mar13 ket that provides health care items and services

14 to an individual or dependent may request (but

15 may not require) that such individual or de16 pendent disclose, or authorize the collection or

17 disclosure of, predictive genetic information for

18 purposes of diagnosis, treatment, or payment re19 lating to the provision of health care items and

20 services to such individual or dependent.

21 ‘‘(B) NOTICE OF CONFIDENTIALITY PRAC22 TICES AND DESCRIPTION OF SAFEGUARDS.—As a

23 part of a request under subparagraph (A), the

24 health insurance issuer offering health insurance

25 coverage in the individual market shall provide
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1 to the individual or dependent a description of

2 the procedures in place to safeguard the con3 fidentiality, as described in subsection (d), of

4 such predictive genetic information.

5 ‘‘(d) CONFIDENTIALITY WITH RESPECT TO PRE6 DICTIVE GENETIC INFORMATION.—

7 ‘‘(1) NOTICE OF CONFIDENTIALITY PRACTICES.—

8 ‘‘(A) PREPARATION OF WRITTEN NOTICE.—

9 A health insurance issuer offering health insur10 ance coverage in the individual market shall post

11 or provide, in writing and in a clear and con12 spicuous manner, notice of the issuer’s confiden13 tiality practices, that shall include—

14 ‘‘(i) a description of an individual’s

15 rights with respect to predictive genetic in16 formation;

17 ‘‘(ii) the procedures established by the

18 issuer for the exercise of the individual’s

19 rights; and

20 ‘‘(iii) the right to obtain a copy of the

21 notice of the confidentiality practices re22 quired under this subsection.

23 ‘‘(B) MODEL NOTICE.—The Secretary, in

24 consultation with the National Committee on

25 Vital and Health Statistics and the National As-
203

•S 326 RS

1 sociation of Insurance Commissioners, and after

2 notice and opportunity for public comment, shall

3 develop and disseminate model notices of con4 fidentiality practices. Use of the model notice

5 shall serve as a defense against claims of receiv6 ing inappropriate notice.

7 ‘‘(2) ESTABLISHMENT OF SAFEGUARDS.—A

8 health insurance issuer offering health insurance cov9 erage in the individual market shall establish and

10 maintain appropriate administrative, technical, and

11 physical safeguards to protect the confidentiality, se12 curity, accuracy, and integrity of predictive genetic

13 information created, received, obtained, maintained,

14 used, transmitted, or disposed of by such issuer.’’.

15 (c) EFFECTIVE DATE.—The amendments made by this

16 section shall apply with respect to—

17 (1) group health plans, and health insurance

18 coverage offered in connection with group health

19 plans, for plan years beginning after 1 year after the

20 date of enactment of this Act; and

21 (2) health insurance coverage offered, sold,

22 issued, renewed, in effect, or operated in the indi23 vidual market after 1 year after the date of enactment

24 of this Act.
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1 SEC. 204. AMENDMENTS TO THE INTERNAL REVENUE CODE

2 OF 1986.

3 (a) PROHIBITION OF HEALTH DISCRIMINATION ON

4 THE BASIS OF GENETIC INFORMATION OR GENETIC SERV5 ICES.—

6 (1) NO ENROLLMENT RESTRICTION FOR GENETIC

7 SERVICES.—Section 9802(a)(1)(F) of the Internal

8 Revenue Code of 1986 is amended by inserting before

9 the period the following: ‘‘(including information

10 about a request for or receipt of genetic services)’’.

11 (2) NO DISCRIMINATION IN GROUP PREMIUMS

12 BASED ON PREDICTIVE GENETIC INFORMATION.—

13 (A) IN GENERAL.—Subchapter B of chapter

14 100 of the Internal Revenue Code of 1986, as

15 amended by section 111(b), is further amended

16 by adding at the end the following:

17 ‘‘SEC. 9814. PROHIBITING PREMIUM DISCRIMINATION

18 AGAINST GROUPS ON THE BASIS OF PRE19 DICTIVE GENETIC INFORMATION.

20 ‘‘A group health plan shall not adjust premium or con21 tribution amounts for a group on the basis of predictive

22 genetic information concerning any individual (including

23 a dependent) or a family member of the individual (includ24 ing information about a request for or receipt of genetic

25 services).’’.
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1 (B) CONFORMING AMENDMENT.—Section

2 9802(b) of the Internal Revenue Code of 1986 is

3 amended by adding at the end the following:

4 ‘‘(3) REFERENCE TO RELATED PROVISION.—For

5 a provision prohibiting the adjustment of premium or

6 contribution amounts for a group under a group

7 health plan on the basis of predictive genetic informa8 tion (including information about a request for or the

9 receipt of genetic services), see section 9814.’’.

10 (C) AMENDMENT TO TABLE OF SECTIONS.—

11 The table of sections for subchapter B of chapter

12 100 of the Internal Revenue Code of 1986, as

13 amended by section 111(b), is further amended

14 by adding at the end the following:

‘‘Sec. 9814. Prohibiting premium discrimination against groups on the basis of

predictive genetic information.’’.

15 (b) LIMITATION ON COLLECTION OF PREDICTIVE GE16 NETIC INFORMATION.—Section 9802 of the Internal Rev17 enue Code of 1986 is amended by adding at the end the

18 following:

19 ‘‘(d) COLLECTION OF PREDICTIVE GENETIC INFORMA20 TION.—

21 ‘‘(1) LIMITATION ON REQUESTING OR REQUIRING

22 PREDICTIVE GENETIC INFORMATION.—Except as pro23 vided in paragraph (2), a group health plan shall not

24 request or require predictive genetic information con-
206

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1 cerning any individual (including a dependent) or a

2 family member of the individual (including informa3 tion about a request for or receipt of genetic services).

4 ‘‘(2) INFORMATION NEEDED FOR DIAGNOSIS,

5 TREATMENT, OR PAYMENT.—

6 ‘‘(A) IN GENERAL.—Notwithstanding para7 graph (1), a group health plan that provides

8 health care items and services to an individual

9 or dependent may request (but may not require)

10 that such individual or dependent disclose, or

11 authorize the collection or disclosure of, pre12 dictive genetic information for purposes of diag13 nosis, treatment, or payment relating to the pro14 vision of health care items and services to such

15 individual or dependent.

16 ‘‘(B) NOTICE OF CONFIDENTIALITY PRAC17 TICES; DESCRIPTION OF SAFEGUARDS.—As a

18 part of a request under subparagraph (A), the

19 group health plan shall provide to the individual

20 or dependent a description of the procedures in

21 place to safeguard the confidentiality, as de22 scribed in subsection (e), of such predictive ge23 netic information.

24 ‘‘(e) CONFIDENTIALITY WITH RESPECT TO PREDICTIVE

25 GENETIC INFORMATION.—
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1 ‘‘(1) NOTICE OF CONFIDENTIALITY PRACTICES.—

2 ‘‘(A) PREPARATION OF WRITTEN NOTICE.—

3 A group health plan shall post or provide, in

4 writing and in a clear and conspicuous manner,

5 notice of the plan’s confidentiality practices, that

6 shall include—

7 ‘‘(i) a description of an individual’s

8 rights with respect to predictive genetic in9 formation;

10 ‘‘(ii) the procedures established by the

11 plan for the exercise of the individual’s

12 rights; and

13 ‘‘(iii) the right to obtain a copy of the

14 notice of the confidentiality practices re15 quired under this subsection.

16 ‘‘(B) MODEL NOTICE.—The Secretary, in

17 consultation with the National Committee on

18 Vital and Health Statistics and the National As19 sociation of Insurance Commissioners, and after

20 notice and opportunity for public comment, shall

21 develop and disseminate model notices of con22 fidentiality practices. Use of the model notice

23 shall serve as a defense against claims of receiv24 ing inappropriate notice.
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1 ‘‘(2) ESTABLISHMENT OF SAFEGUARDS.—A

2 group health plan shall establish and maintain ap3 propriate administrative, technical, and physical

4 safeguards to protect the confidentiality, security, ac5 curacy, and integrity of predictive genetic informa6 tion created, received, obtained, maintained, used,

7 transmitted, or disposed of by such plan.’’.

8 (c) DEFINITIONS.—Section 9832(d) of the Internal

9 Revenue Code of 1986 is amended by adding at the end

10 the following:

11 ‘‘(6) FAMILY MEMBER.—The term ‘family mem12 ber’ means, with respect to an individual—

13 ‘‘(A) the spouse of the individual;

14 ‘‘(B) a dependent child of the individual,

15 including a child who is born to or placed for

16 adoption with the individual; and

17 ‘‘(C) all other individuals related by blood

18 to the individual or the spouse or child described

19 in subparagraph (A) or (B).

20 ‘‘(7) GENETIC INFORMATION.—The term ‘genetic

21 information’ means information about genes, gene

22 products, or inherited characteristics that may derive

23 from an individual or a family member (including

24 information about a request for or receipt of genetic

25 services).
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1 ‘‘(8) GENETIC SERVICES.—The term ‘genetic

2 services’ means health services provided to obtain, as3 sess, or interpret genetic information for diagnostic

4 and therapeutic purposes, and for genetic education

5 and counseling.

6 ‘‘(9) PREDICTIVE GENETIC INFORMATION.—

7 ‘‘(A) IN GENERAL.—The term ‘predictive ge8 netic information’ means, in the absence of

9 symptoms, clinical signs, or a diagnosis of the

10 condition related to such information—

11 ‘‘(i) information about an individual’s

12 genetic tests;

13 ‘‘(ii) information about genetic tests of

14 family members of the individual; or

15 ‘‘(iii) information about the occurrence

16 of a disease or disorder in family members.

17 ‘‘(B) EXCEPTIONS.—The term ‘predictive

18 genetic information’ shall not include—

19 ‘‘(i) information about the sex or age of

20 the individual;

21 ‘‘(ii) information derived from phys22 ical tests, such as the chemical, blood, or

23 urine analyses of the individual including

24 cholesterol tests; and
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1 ‘‘(iii) information about physical

2 exams of the individual.

3 ‘‘(10) GENETIC TEST.—The term ‘genetic test’

4 means the analysis of human DNA, RNA, chro5 mosomes, proteins, and certain metabolites, including

6 analysis of genotypes, mutations, phenotypes, or

7 karyotypes, for the purpose of predicting risk of dis8 ease in asymptomatic or undiagnosed individuals.

9 Such term does not include physical tests, such as the

10 chemical, blood, or urine analyses of the individual

11 including cholesterol tests, and physical exams of the

12 individual, in order to detect symptoms, clinical

13 signs, or a diagnosis of disease.’’.

14 (d) EFFECTIVE DATE.—Except as provided in this sec15 tion, this section and the amendments made by this section

16 shall apply with respect to group health plans for plan

17 years beginning after 1 year after the date of the enactment

18 of this Act.

19 TITLE III—HEALTHCARE

20 RESEARCH AND QUALITY

21 SEC. 301. SHORT TITLE.

22 This title may be cited as the ‘‘Healthcare Research

23 and Quality Act of 1999’’.
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1 SEC. 302. AMENDMENT TO THE PUBLIC HEALTH SERVICE

2 ACT.

3 Title IX of the Public Health Service Act (42 U.S.C.

4 299 et seq.) is amended to read as follows:

5 ‘‘TITLE IX—AGENCY FOR

6 HEALTHCARE RESEARCH AND

7 QUALITY

8 ‘‘PART A—ESTABLISHMENT AND GENERAL

9 DUTIES

10 ‘‘SEC. 901. MISSION AND DUTIES.

11 ‘‘(a) IN GENERAL.—There is established within the

12 Public Health Service an agency to be known as the Agency

13 for Healthcare Research and Quality. In carrying out this

14 subsection, the Secretary shall redesignate the Agency for

15 Health Care Policy and Research as the Agency for

16 Healthcare Research and Quality.

17 ‘‘(b) MISSION.—The purpose of the Agency is to en18 hance the quality, appropriateness, and effectiveness of

19 healthcare services, and access to such services, through the

20 establishment of a broad base of scientific research and

21 through the promotion of improvements in clinical and

22 health system practices, including the prevention of diseases

23 and other health conditions. The Agency shall promote

24 healthcare quality improvement by—
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1 ‘‘(1) conducting and supporting research that de2 velops and presents scientific evidence regarding all

3 aspects of healthcare, including—

4 ‘‘(A) the development and assessment of

5 methods for enhancing patient participation in

6 their own care and for facilitating shared pa7 tient-physician decision-making;

8 ‘‘(B) the outcomes, effectiveness, and cost-ef9 fectiveness of healthcare practices, including pre10 ventive measures and long-term care;

11 ‘‘(C) existing and innovative technologies;

12 ‘‘(D) the costs and utilization of, and access

13 to healthcare;

14 ‘‘(E) the ways in which healthcare services

15 are organized, delivered, and financed and the

16 interaction and impact of these factors on the

17 quality of patient care;

18 ‘‘(F) methods for measuring quality and

19 strategies for improving quality; and

20 ‘‘(G) ways in which patients, consumers,

21 purchasers, and practitioners acquire new infor22 mation about best practices and health benefits,

23 the determinants and impact of their use of this

24 information;
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1 ‘‘(2) synthesizing and disseminating available

2 scientific evidence for use by patients, consumers,

3 practitioners, providers, purchasers, policy makers,

4 and educators; and

5 ‘‘(3) advancing private and public efforts to im6 prove healthcare quality.

7 ‘‘(c) REQUIREMENTS WITH RESPECT TO RURAL

8 AREAS AND PRIORITY POPULATIONS.—In carrying out sub9 section (b), the Director shall undertake and support re10 search, demonstration projects, and evaluations with respect

11 to the delivery of health services—

12 ‘‘(1) in rural areas (including frontier areas);

13 ‘‘(2) for low-income groups, and minority

14 groups;

15 ‘‘(3) for children;

16 ‘‘(4) for elderly; and

17 ‘‘(5) for people with special healthcare needs, in18 cluding disabilities, chronic care and end-of-life

19 healthcare.

20 ‘‘(d) APPOINTMENT OF DIRECTOR.—There shall be at

21 the head of the Agency an official to be known as the Direc22 tor for Healthcare Research and Quality. The Director shall

23 be appointed by the Secretary. The Secretary, acting

24 through the Director, shall carry out the authorities and

25 duties established in this title.
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1 ‘‘SEC. 902. GENERAL AUTHORITIES.

2 ‘‘(a) IN GENERAL.—In carrying out section 901(b), the

3 Director shall support demonstration projects, conduct and

4 support research, evaluations, training, research networks,

5 multi-disciplinary centers, technical assistance, and the dis6 semination of information, on healthcare, and on systems

7 for the delivery of such care, including activities with re8 spect to—

9 ‘‘(1) the quality, effectiveness, efficiency, appro10 priateness and value of healthcare services;

11 ‘‘(2) quality measurement and improvement;

12 ‘‘(3) the outcomes, cost, cost-effectiveness, and use

13 of healthcare services and access to such services;

14 ‘‘(4) clinical practice, including primary care

15 and practice-oriented research;

16 ‘‘(5) healthcare technologies, facilities, and equip17 ment;

18 ‘‘(6) healthcare costs, productivity, organization,

19 and market forces;

20 ‘‘(7) health promotion and disease prevention,

21 including clinical preventive services;

22 ‘‘(8) health statistics, surveys, database develop23 ment, and epidemiology; and

24 ‘‘(9) medical liability.

25 ‘‘(b) HEALTH SERVICES TRAINING GRANTS.—
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1 ‘‘(1) IN GENERAL.—The Director may provide

2 training grants in the field of health services research

3 related to activities authorized under subsection (a),

4 to include pre- and post-doctoral fellowships and

5 training programs, young investigator awards, and

6 other programs and activities as appropriate. In car7 rying out this subsection, the Director shall make use

8 of funds made available under section 487 as well as

9 other appropriated funds.

10 ‘‘(2) REQUIREMENTS.—In developing priorities

11 for the allocation of training funds under this sub12 section, the Director shall take into consideration

13 shortages in the number of trained researchers ad14 dressing the priority populations.

15 ‘‘(c) MULTIDISCIPLINARY CENTERS.—The Director

16 may provide financial assistance to assist in meeting the

17 costs of planning and establishing new centers, and oper18 ating existing and new centers, for multidisciplinary health

19 services research, demonstration projects, evaluations,

20 training, and policy analysis with respect to the matters

21 referred to in subsection (a).

22 ‘‘(d) RELATION TO CERTAIN AUTHORITIES REGARD23 ING SOCIAL SECURITY.—Activities authorized in this sec24 tion shall be appropriately coordinated with experiments,

25 demonstration projects, and other related activities author-
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1 ized by the Social Security Act and the Social Security

2 Amendments of 1967. Activities under subsection (a)(2) of

3 this section that affect the programs under titles XVIII, XIX

4 and XXI of the Social Security Act shall be carried out

5 consistent with section 1142 of such Act.

6 ‘‘(e) DISCLAIMER.—The Agency shall not mandate na7 tional standards of clinical practice or quality healthcare

8 standards. Recommendations resulting from projects funded

9 and published by the Agency shall include a corresponding

10 disclaimer.

11 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec12 tion shall be construed to imply that the Agency’s role is

13 to mandate a national standard or specific approach to

14 quality measurement and reporting. In research and qual15 ity improvement activities, the Agency shall consider a wide

16 range of choices, providers, healthcare delivery systems, and

17 individual preferences.

18 ‘‘PART B—HEALTHCARE IMPROVEMENT

19 RESEARCH

20 ‘‘SEC. 911. HEALTHCARE OUTCOME IMPROVEMENT RE21 SEARCH.

22 ‘‘(a) EVIDENCE RATING SYSTEMS.—In collaboration

23 with experts from the public and private sector, the Agency

24 shall identify and disseminate methods or systems that it

25 uses to assess healthcare research results, particularly meth-
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1 ods or systems that it uses to rate the strength of the sci2 entific evidence behind healthcare practice, recommenda3 tions in the research literature, and technology assessments.

4 The Agency shall make methods and systems for evidence

5 rating widely available. Agency publications containing

6 healthcare recommendations shall indicate the level of sub7 stantiating evidence using such methods or systems.

8 ‘‘(b) HEALTHCARE IMPROVEMENT RESEARCH CEN9 TERS AND PROVIDER-BASED RESEARCH NETWORKS.—In

10 order to address the full continuum of care and outcomes

11 research, to link research to practice improvement, and to

12 speed the dissemination of research findings to community

13 practice settings, the Agency shall employ research strate14 gies and mechanisms that will link research directly with

15 clinical practice in geographically diverse locations

16 throughout the United States, including—

17 ‘‘(1) Healthcare Improvement Research Centers

18 that combine demonstrated multidisciplinary exper19 tise in outcomes or quality improvement research

20 with linkages to relevant sites of care;

21 ‘‘(2) Provider-based Research Networks, includ22 ing plan, facility, or delivery system sites of care (es23 pecially primary care), that can evaluate and pro24 mote quality improvement; and
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1 ‘‘(3) other innovative mechanisms or strategies to

2 link research with clinical practice.

3 ‘‘SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE

4 ORGANIZATION AND DELIVERY.

5 ‘‘(a) SUPPORT FOR EFFORTS TO DEVELOP INFORMA6 TION ON QUALITY.—

7 ‘‘(1) SCIENTIFIC AND TECHNICAL SUPPORT.—In

8 its role as the principal agency for healthcare research

9 and quality, the Agency may provide scientific and

10 technical support for private and public efforts to im11 prove healthcare quality, including the activities of

12 accrediting organizations.

13 ‘‘(2) ROLE OF THE AGENCY.—With respect to

14 paragraph (1), the role of the Agency shall include—

15 ‘‘(A) the identification and assessment of

16 methods for the evaluation of the health of—

17 ‘‘(i) enrollees in health plans by type of

18 plan, provider, and provider arrangements;

19 and

20 ‘‘(ii) other populations, including those

21 receiving long-term care services;

22 ‘‘(B) the ongoing development, testing, and

23 dissemination of quality measures, including

24 measures of health and functional outcomes;
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1 ‘‘(C) the compilation and dissemination of

2 healthcare quality measures developed in the pri3 vate and public sector;

4 ‘‘(D) assistance in the development of im5 proved healthcare information systems;

6 ‘‘(E) the development of survey tools for the

7 purpose of measuring participant and bene8 ficiary assessments of their healthcare; and

9 ‘‘(F) identifying and disseminating infor10 mation on mechanisms for the integration of in11 formation on quality into purchaser and con12 sumer decision-making processes.

13 ‘‘(b) CENTERS FOR EDUCATION AND RESEARCH ON

14 THERAPEUTICS.—

15 ‘‘(1) IN GENERAL.—The Secretary, acting

16 through the Director and in consultation with the

17 Commissioner of Food and Drugs, shall establish a

18 program for the purpose of making one or more

19 grants for the establishment and operation of one or

20 more centers to carry out the activities specified in

21 paragraph (2).

22 ‘‘(2) REQUIRED ACTIVITIES.—The activities re23 ferred to in this paragraph are the following:
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1 ‘‘(A) The conduct of state-of-the-art clinical,

2 laboratory, or health services research for the fol3 lowing purposes:

4 ‘‘(i) To increase awareness of—

5 ‘‘(I) new uses of drugs, biological

6 products, and devices;

7 ‘‘(II) ways to improve the effective

8 use of drugs, biological products, and

9 devices; and

10 ‘‘(III) risks of new uses and risks

11 of combinations of drugs and biological

12 products.

13 ‘‘(ii) To provide objective clinical in14 formation to the following individuals and

15 entities:

16 ‘‘(I) Healthcare practitioners and

17 other providers of healthcare goods or

18 services.

19 ‘‘(II) Pharmacists, pharmacy ben20 efit managers and purchasers.

21 ‘‘(III) Health maintenance orga22 nizations and other managed

23 healthcare organizations.

24 ‘‘(IV) Healthcare insurers and

25 governmental agencies.
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1 ‘‘(V) Patients and consumers.

2 ‘‘(iii) To improve the quality of

3 healthcare while reducing the cost of

4 Healthcare through—

5 ‘‘(I) an increase in the appro6 priate use of drugs, biological products,

7 or devices; and

8 ‘‘(II) the prevention of adverse ef9 fects of drugs, biological products, and

10 devices and the consequences of such ef11 fects, such as unnecessary hospitaliza12 tions.

13 ‘‘(B) The conduct of research on the com14 parative effectiveness, cost-effectiveness, and safe15 ty of drugs, biological products, and devices.

16 ‘‘(C) Such other activities as the Secretary

17 determines to be appropriate, except that grant

18 funds may not be used by the Secretary in con19 ducting regulatory review of new drugs.

20 ‘‘(c) REDUCING ERRORS IN MEDICINE.—The Director

21 shall conduct and support research and build private-public

22 partnerships to—

23 ‘‘(1) identify the causes of preventable healthcare

24 errors and patient injury in healthcare delivery;
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1 ‘‘(2) develop, demonstrate, and evaluate strate2 gies for reducing errors and improving patient safety;

3 and

4 ‘‘(3) promote the implementation of effective

5 strategies throughout the healthcare industry.

6 ‘‘SEC. 913. INFORMATION ON QUALITY AND COST OF CARE.

7 ‘‘(a) IN GENERAL.—In carrying out 902(a), the Direc8 tor shall—

9 ‘‘(1) conduct a survey to collect data on a na10 tionally representative sample of the population on

11 the cost, use and, for fiscal year 2001 and subsequent

12 fiscal years, quality of healthcare, including the types

13 of healthcare services Americans use, their access to

14 healthcare services, frequency of use, how much is

15 paid for the services used, the source of those pay16 ments, the types and costs of private health insurance,

17 access, satisfaction, and quality of care for the general

18 population including rural residents and for the pop19 ulations identified in section 901(c); and

20 ‘‘(2) develop databases and tools that provide in21 formation to States on the quality, access, and use of

22 healthcare services provided to their residents.

23 ‘‘(b) QUALITY AND OUTCOMES INFORMATION.—
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1 ‘‘(1) IN GENERAL.—Beginning in fiscal year

2 2001, the Director shall ensure that the survey con3 ducted under subsection (a)(1) will—

4 ‘‘(A) identify determinants of health out5 comes and functional status, and their relation6 ships to healthcare access and use, determine the

7 ways and extent to which the priority popu8 lations enumerated in section 901(c) differ from

9 the general population with respect to such vari10 ables, measure changes over time with respect to

11 such variable, and monitor the overall national

12 impact of changes in Federal and State policy

13 on healthcare;

14 ‘‘(B) provide information on the quality of

15 care and patient outcomes for frequently occur16 ring clinical conditions for a nationally rep17 resentative sample of the population including

18 rural residents; and

19 ‘‘(C) provide reliable national estimates for

20 children and persons with special healthcare

21 needs through the use of supplements or periodic

22 expansions of the survey.

23 In expanding the Medical Expenditure Panel Survey,

24 as in existence on the date of enactment of this title,

25 in fiscal year 2001 to collect information on the qual-
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1 ity of care, the Director shall take into account any

2 outcomes measurements generally collected by private

3 sector accreditation organizations.

4 ‘‘(2) ANNUAL REPORT.—Beginning in fiscal year

5 2003, the Secretary, acting through the Director, shall

6 submit to Congress an annual report on national

7 trends in the quality of healthcare provided to the

8 American people.

9 ‘‘SEC. 914. INFORMATION SYSTEMS FOR HEALTHCARE IM10 PROVEMENT.

11 ‘‘(a) IN GENERAL.—In order to foster a range of inno12 vative approaches to the management and communication

13 of health information, the Agency shall support research,

14 evaluations and initiatives to advance—

15 ‘‘(1) the use of information systems for the study

16 of healthcare quality, including the generation of both

17 individual provider and plan-level comparative per18 formance data;

19 ‘‘(2) training for healthcare practitioners and re20 searchers in the use of information systems;

21 ‘‘(3) the creation of effective linkages between

22 various sources of health information, including the

23 development of information networks;
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1 ‘‘(4) the delivery and coordination of evidence2 based healthcare services, including the use of real3 time healthcare decision-support programs;

4 ‘‘(5) the utility and comparability of health in5 formation data and medical vocabularies by address6 ing issues related to the content, structure, definitions

7 and coding of such information and data in consulta8 tion with appropriate Federal, State and private en9 tities;

10 ‘‘(6) the use of computer-based health records in

11 all settings for the development of personal health

12 records for individual health assessment and mainte13 nance, and for monitoring public health and outcomes

14 of care within populations; and

15 ‘‘(7) the protection of individually identifiable

16 information in health services research and healthcare

17 quality improvement.

18 ‘‘(b) DEMONSTRATION.—The Agency shall support

19 demonstrations into the use of new information tools aimed

20 at improving shared decision-making between patients and

21 their care-givers.

22 ‘‘SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND AC23 CESS IN UNDERSERVED AREAS.

24 ‘‘(a) PREVENTIVE SERVICES TASK FORCE.—
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1 ‘‘(1) ESTABLISHMENT AND PURPOSE.—The Di2 rector may periodically convene a Preventive Services

3 Task Force to be composed of individuals with appro4 priate expertise. Such a task force shall review the

5 scientific evidence related to the effectiveness, appro6 priateness, and cost-effectiveness of clinical preventive

7 services for the purpose of developing recommenda8 tions for the healthcare community, and updating

9 previous clinical preventive recommendations.

10 ‘‘(2) ROLE OF AGENCY.—The Agency shall pro11 vide ongoing administrative, research, and technical

12 support for the operations of the Preventive Services

13 Task Force, including coordinating and supporting

14 the dissemination of the recommendations of the Task

15 Force.

16 ‘‘(3) OPERATION.—In carrying out its respon17 sibilities under paragraph (1), the Task Force is not

18 subject to the provisions of Appendix 2 of title 5,

19 United States Code.

20 ‘‘(b) PRIMARY CARE RESEARCH.—

21 ‘‘(1) IN GENERAL.—There is established within

22 the Agency a Center for Primary Care Research (re23 ferred to in this subsection as the ‘Center’) that shall

24 serve as the principal source of funding for primary

25 care practice research in the Department of Health
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1 and Human Services. For purposes of this paragraph,

2 primary care research focuses on the first contact

3 when illness or health concerns arise, the diagnosis,

4 treatment or referral to specialty care, preventive

5 care, and the relationship between the clinician and

6 the patient in the context of the family and commu7 nity.

8 ‘‘(2) RESEARCH.—In carrying out this section,

9 the Center shall conduct and support research

10 concerning—

11 ‘‘(A) the nature and characteristics of pri12 mary care practice;

13 ‘‘(B) the management of commonly occur14 ring clinical problems;

15 ‘‘(C) the management of undifferentiated

16 clinical problems; and

17 ‘‘(D) the continuity and coordination of

18 health services.

19 ‘‘SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVA20 TION.

21 ‘‘(a) IN GENERAL.—The Director shall promote inno22 vation in evidence-based clinical practice and healthcare

23 technologies by—
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1 ‘‘(1) conducting and supporting research on the

2 development, diffusion, and use of healthcare tech3 nology;

4 ‘‘(2) developing, evaluating, and disseminating

5 methodologies for assessments of healthcare practices

6 and healthcare technologies;

7 ‘‘(3) conducting intramural and supporting ex8 tramural assessments of existing and new healthcare

9 practices and technologies;

10 ‘‘(4) promoting education, training, and pro11 viding technical assistance in the use of healthcare

12 practice and healthcare technology assessment meth13 odologies and results; and

14 ‘‘(5) working with the National Library of Medi15 cine and the public and private sector to develop an

16 electronic clearinghouse of currently available assess17 ments and those in progress.

18 ‘‘(b) SPECIFICATION OF PROCESS.—

19 ‘‘(1) IN GENERAL.—Not later than December 31,

20 2000, the Director shall develop and publish a de21 scription of the methodology used by the Agency and

22 its contractors in conducting practice and technology

23 assessment.

24 ‘‘(2) CONSULTATIONS.—In carrying out this sub25 section, the Director shall cooperate and consult with
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1 the Assistant Secretary for Health, the Administrator

2 of the Health Care Financing Administration, the Di3 rector of the National Institutes of Health, the Com4 missioner of Food and Drugs, and the heads of any

5 other interested Federal department or agency, and

6 shall seek input, where appropriate, from professional

7 societies and other private and public entities.

8 ‘‘(3) METHODOLOGY.—The Director, in devel9 oping assessment methodology, shall consider—

10 ‘‘(A) safety, efficacy, and effectiveness;

11 ‘‘(B) legal, social, and ethical implications;

12 ‘‘(C) costs, benefits, and cost-effectiveness;

13 ‘‘(D) comparisons to alternate technologies

14 and practices; and

15 ‘‘(E) requirements of Food and Drug Ad16 ministration approval to avoid duplication.

17 ‘‘(c) SPECIFIC ASSESSMENTS.—

18 ‘‘(1) IN GENERAL.—The Director shall conduct

19 or support specific assessments of healthcare tech20 nologies and practices.

21 ‘‘(2) REQUESTS FOR ASSESSMENTS.—The Direc22 tor is authorized to conduct or support assessments,

23 on a reimbursable basis, for the Health Care Financ24 ing Administration, the Department of Defense, the

25 Department of Veterans Affairs, the Office of Per-
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1 sonnel Management, and other public or private enti2 ties.

3 ‘‘(3) GRANTS AND CONTRACTS.—In addition to

4 conducting assessments, the Director may make

5 grants to, or enter into cooperative agreements or con6 tracts with, entities described in paragraph (4) for

7 the purpose of conducting assessments of experi8 mental, emerging, existing, or potentially outmoded

9 healthcare technologies, and for related activities.

10 ‘‘(4) ELIGIBLE ENTITIES.—An entity described

11 in this paragraph is an entity that is determined to

12 be appropriate by the Director, including academic

13 medical centers, research institutions and organiza14 tions, professional organizations, third party payers,

15 governmental agencies, and consortia of appropriate

16 research entities established for the purpose of con17 ducting technology assessments.

18 ‘‘SEC. 917. COORDINATION OF FEDERAL GOVERNMENT

19 QUALITY IMPROVEMENT EFFORTS.

20 ‘‘(a) REQUIREMENT.—

21 ‘‘(1) IN GENERAL.—To avoid duplication and

22 ensure that Federal resources are used efficiently and

23 effectively, the Secretary, acting through the Director,

24 shall coordinate all research, evaluations, and dem25 onstrations related to health services research, quality
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1 measurement and quality improvement activities un2 dertaken and supported by the Federal Government.

3 ‘‘(2) SPECIFIC ACTIVITIES.—The Director, in col4 laboration with the appropriate Federal officials rep5 resenting all concerned executive agencies and depart6 ments, shall develop and manage a process to—

7 ‘‘(A) improve interagency coordination, pri8 ority setting, and the use and sharing of research

9 findings and data pertaining to Federal quality

10 improvement programs, technology assessment,

11 and health services research;

12 ‘‘(B) strengthen the research information

13 infrastructure, including databases, pertaining

14 to Federal health services research and healthcare

15 quality improvement initiatives;

16 ‘‘(C) set specific goals for participating

17 agencies and departments to further health serv18 ices research and healthcare quality improve19 ment; and

20 ‘‘(D) strengthen the management of Federal

21 healthcare quality improvement programs.

22 ‘‘(b) STUDY BY THE INSTITUTE OF MEDICINE.—

23 ‘‘(1) IN GENERAL.—To provide Congress, the De24 partment of Health and Human Services, and other

25 relevant departments with an independent, external
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1 review of their quality oversight, quality improvement

2 and quality research programs, the Secretary shall

3 enter into a contract with the Institute of Medicine—

4 ‘‘(A) to describe and evaluate current qual5 ity improvement, quality research and quality

6 monitoring processes through—

7 ‘‘(i) an overview of pertinent health

8 services research activities and quality im9 provement efforts conducted by all Federal

10 programs, with particular attention paid to

11 those under titles XVIII, XIX, and XXI of

12 the Social Security Act; and

13 ‘‘(ii) a summary of the partnerships

14 that the Department of Health and Human

15 Services has pursued with private accredi16 tation, quality measurement and improve17 ment organizations; and

18 ‘‘(B) to identify options and make rec19 ommendations to improve the efficiency and ef20 fectiveness of quality improvement programs

21 through—

22 ‘‘(i) the improved coordination of ac23 tivities across the medicare, medicaid and

24 child health insurance programs under titles
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1 XVIII, XIX and XXI of the Social Security

2 Act and health services research programs;

3 ‘‘(ii) the strengthening of patient choice

4 and participation by incorporating state-of5 the-art quality monitoring tools and mak6 ing information on quality available; and

7 ‘‘(iii) the enhancement of the most ef8 fective programs, consolidation as appro9 priate, and elimination of duplicative ac10 tivities within various federal agencies.

11 ‘‘(2) REQUIREMENTS.—

12 ‘‘(A) IN GENERAL.—The Secretary shall

13 enter into a contract with the Institute of Medi14 cine for the preparation—

15 ‘‘(i) not later than 12 months after the

16 date of enactment of this title, of a report

17 providing an overview of the quality im18 provement programs of the Department of

19 Health and Human Services for the medi20 care, medicaid, and CHIP programs under

21 titles XVIII, XIX, and XXI of the Social Se22 curity Act; and

23 ‘‘(ii) not later than 24 months after the

24 date of enactment of this title, of a final re25 port containing recommendations.
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1 ‘‘(B) REPORTS.—The Secretary shall sub2 mit the reports described in subparagraph (A) to

3 the Committee on Finance and the Committee on

4 Health, Education, Labor, and Pensions of the

5 Senate and the Committee on Ways and Means

6 and the Committee on Commerce of the House of

7 Representatives.

8 ‘‘PART C—GENERAL PROVISIONS

9 ‘‘SEC. 921. ADVISORY COUNCIL FOR HEALTHCARE RE10 SEARCH AND QUALITY.

11 ‘‘(a) ESTABLISHMENT.—There is established an advi12 sory council to be known as the Advisory Council for

13 Healthcare Research and Quality.

14 ‘‘(b) DUTIES.—

15 ‘‘(1) IN GENERAL.—The Advisory Council shall

16 advise the Secretary and the Director with respect to

17 activities proposed or undertaken to carry out the

18 purpose of the Agency under section 901(b).

19 ‘‘(2) CERTAIN RECOMMENDATIONS.—Activities of

20 the Advisory Council under paragraph (1) shall in21 clude making recommendations to the Director

22 regarding—

23 ‘‘(A) priorities regarding healthcare re24 search, especially studies related to quality, out-
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1 comes, cost and the utilization of, and access to,

2 healthcare services;

3 ‘‘(B) the field of healthcare research and re4 lated disciplines, especially issues related to

5 training needs, and dissemination of informa6 tion pertaining to healthcare quality; and

7 ‘‘(C) the appropriate role of the Agency in

8 each of these areas in light of private sector ac9 tivity and identification of opportunities for

10 public-private sector partnerships.

11 ‘‘(c) MEMBERSHIP.—

12 ‘‘(1) IN GENERAL.—The Advisory Council shall,

13 in accordance with this subsection, be composed of ap14 pointed members and ex officio members. All members

15 of the Advisory Council shall be voting members other

16 than the individuals designated under paragraph

17 (3)(B) as ex officio members.

18 ‘‘(2) APPOINTED MEMBERS.—The Secretary shall

19 appoint to the Advisory Council 21 appropriately

20 qualified individuals. At least 17 members of the Ad21 visory Council shall be representatives of the public

22 who are not officers or employees of the United States.

23 The Secretary shall ensure that the appointed mem24 bers of the Council, as a group, are representative of

25 professions and entities concerned with, or affected by,
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1 activities under this title and under section 1142 of

2 the Social Security Act. Of such members—

3 ‘‘(A) 4 shall be individuals distinguished in

4 the conduct of research, demonstration projects,

5 and evaluations with respect to healthcare;

6 ‘‘(B) 4 shall be individuals distinguished in

7 the practice of medicine of which at least 1 shall

8 be a primary care practitioner;

9 ‘‘(C) 3 shall be individuals distinguished in

10 the other health professions;

11 ‘‘(D) 4 shall be individuals either rep12 resenting the private healthcare sector, including

13 health plans, providers, and purchasers or indi14 viduals distinguished as administrators of

15 healthcare delivery systems;

16 ‘‘(E) 4 shall be individuals distinguished in

17 the fields of healthcare quality improvement, eco18 nomics, information systems, law, ethics, busi19 ness, or public policy, including at least 1 indi20 vidual specializing in rural aspects in 1 or more

21 of these fields; and

22 ‘‘(F) 2 shall be individuals representing the

23 interests of patients and consumers of healthcare.
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1 ‘‘(3) EX OFFICIO MEMBERS.—The Secretary shall

2 designate as ex officio members of the Advisory

3 Council—

4 ‘‘(A) the Assistant Secretary for Health, the

5 Director of the National Institutes of Health, the

6 Director of the Centers for Disease Control and

7 Prevention, the Administrator of the Health Care

8 Financing Administration, the Assistant Sec9 retary of Defense (Health Affairs), and the

10 Under Secretary for Health of the Department of

11 Veterans Affairs; and

12 ‘‘(B) such other Federal officials as the Sec13 retary may consider appropriate.

14 ‘‘(d) TERMS.—Members of the Advisory Council ap15 pointed under subsection (c)(2) shall serve for a term of 3

16 years. A member of the Council appointed under such sub17 section may continue to serve after the expiration of the

18 term of the members until a successor is appointed.

19 ‘‘(e) VACANCIES.—If a member of the Advisory Council

20 appointed under subsection (c)(2) does not serve the full

21 term applicable under subsection (d), the individual ap22 pointed to fill the resulting vacancy shall be appointed for

23 the remainder of the term of the predecessor of the indi24 vidual.
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1 ‘‘(f) CHAIR.—The Director shall, from among the

2 members of the Advisory Council appointed under sub3 section (c)(2), designate an individual to serve as the chair

4 of the Advisory Council.

5 ‘‘(g) MEETINGS.—The Advisory Council shall meet not

6 less than once during each discrete 4-month period and

7 shall otherwise meet at the call of the Director or the chair.

8 ‘‘(h) COMPENSATION AND REIMBURSEMENT OF EX9 PENSES.—

10 ‘‘(1) APPOINTED MEMBERS.—Members of the Ad11 visory Council appointed under subsection (c)(2) shall

12 receive compensation for each day (including travel

13 time) engaged in carrying out the duties of the Advi14 sory Council unless declined by the member. Such

15 compensation may not be in an amount in excess of

16 the daily equivalent of the annual rate of basic pay

17 prescribed for level IV of the Executive Schedule

18 under section 5315 of title 5, United States Code, for

19 each day during which such member is engaged in the

20 performance of the duties of the Advisory Council.

21 ‘‘(2) EX OFFICIO MEMBERS.—Officials des22 ignated under subsection (c)(3) as ex officio members

23 of the Advisory Council may not receive compensation

24 for service on the Advisory Council in addition to the
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1 compensation otherwise received for duties carried out

2 as officers of the United States.

3 ‘‘(i) STAFF.—The Director shall provide to the Advi4 sory Council such staff, information, and other assistance

5 as may be necessary to carry out the duties of the Council.

6 ‘‘SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND

7 CONTRACTS.

8 ‘‘(a) REQUIREMENT OF REVIEW.—

9 ‘‘(1) IN GENERAL.—Appropriate technical and

10 scientific peer review shall be conducted with respect

11 to each application for a grant, cooperative agree12 ment, or contract under this title.

13 ‘‘(2) REPORTS TO DIRECTOR.—Each peer review

14 group to which an application is submitted pursuant

15 to paragraph (1) shall report its finding and rec16 ommendations respecting the application to the Direc17 tor in such form and in such manner as the Director

18 shall require.

19 ‘‘(b) APPROVAL AS PRECONDITION OF AWARDS.—The

20 Director may not approve an application described in sub21 section (a)(1) unless the application is recommended for ap22 proval by a peer review group established under subsection

23 (c).

24 ‘‘(c) ESTABLISHMENT OF PEER REVIEW GROUPS.—
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1 ‘‘(1) IN GENERAL.—The Director shall establish

2 such technical and scientific peer review groups as

3 may be necessary to carry out this section. Such

4 groups shall be established without regard to the pro5 visions of title 5, United States Code, that govern ap6 pointments in the competitive service, and without re7 gard to the provisions of chapter 51, and subchapter

8 III of chapter 53, of such title that relate to classifica9 tion and pay rates under the General Schedule.

10 ‘‘(2) MEMBERSHIP.—The members of any peer

11 review group established under this section shall be

12 appointed from among individuals who by virtue of

13 their training or experience are eminently qualified

14 to carry out the duties of such peer review group. Of15 ficers and employees of the United States may not

16 constitute more than 25 percent of the membership of

17 any such group. Such officers and employees may not

18 receive compensation for service on such groups in ad19 dition to the compensation otherwise received for these

20 duties carried out as such officers and employees.

21 ‘‘(3) DURATION.—Notwithstanding section 14(a)

22 of the Federal Advisory Committee Act, peer review

23 groups established under this section may continue in

24 existence until otherwise provided by law.
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1 ‘‘(4) QUALIFICATIONS.—Members of any peer-re2 view group shall, at a minimum, meet the following

3 requirements:

4 ‘‘(A) Such members shall agree in writing

5 to treat information received, pursuant to their

6 work for the group, as confidential information,

7 except that this subparagraph shall not apply to

8 public records and public information.

9 ‘‘(B) Such members shall agree in writing

10 to recuse themselves from participation in the

11 peer-review of specific applications which present

12 a potential personal conflict of interest or ap13 pearance of such conflict, including employment

14 in a directly affected organization, stock owner15 ship, or any financial or other arrangement that

16 might introduce bias in the process of peer-re17 view.

18 ‘‘(d) AUTHORITY FOR PROCEDURAL ADJUSTMENTS IN

19 CERTAIN CASES.—In the case of applications for financial

20 assistance whose direct costs will not exceed $100,000, the

21 Director may make appropriate adjustments in the proce22 dures otherwise established by the Director for the conduct

23 of peer review under this section. Such adjustments may

24 be made for the purpose of encouraging the entry of individ25 uals into the field of research, for the purpose of encour-
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1 aging clinical practice-oriented or provider-based research,

2 and for such other purposes as the Director may determine

3 to be appropriate.

4 ‘‘(e) REGULATIONS.—The Director shall issue regula5 tions for the conduct of peer review under this section.

6 ‘‘SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVEL7 OPMENT, COLLECTION, AND DISSEMINATION

8 OF DATA.

9 ‘‘(a) STANDARDS WITH RESPECT TO UTILITY OF

10 DATA.—

11 ‘‘(1) IN GENERAL.—To ensure the utility, accu12 racy, and sufficiency of data collected by or for the

13 Agency for the purpose described in section 901(b),

14 the Director shall establish standard methods for de15 veloping and collecting such data, taking into

16 consideration—

17 ‘‘(A) other Federal health data collection

18 standards; and

19 ‘‘(B) the differences between types of

20 healthcare plans, delivery systems, healthcare

21 providers, and provider arrangements.

22 ‘‘(2) RELATIONSHIP WITH OTHER DEPARTMENT

23 PROGRAMS.—In any case where standards under

24 paragraph (1) may affect the administration of other

25 programs carried out by the Department of Health
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1 and Human Services, including the programs under

2 title XVIII, XIX or XXI of the Social Security Act,

3 or may affect health information that is subject to a

4 standard developed under part C of title XI of the So5 cial Security Act, they shall be in the form of rec6 ommendations to the Secretary for such program.

7 ‘‘(b) STATISTICS AND ANALYSES.—The Director

8 shall—

9 ‘‘(1) take appropriate action to ensure that sta10 tistics and analyses developed under this title are of

11 high quality, timely, and duly comprehensive, and

12 that the statistics are specific, standardized, and ade13 quately analyzed and indexed; and

14 ‘‘(2) publish, make available, and disseminate

15 such statistics and analyses on as wide a basis as is

16 practicable.

17 ‘‘(c) AUTHORITY REGARDING CERTAIN REQUESTS.—

18 Upon request of a public or private entity, the Director may

19 conduct or support research or analyses otherwise author20 ized by this title pursuant to arrangements under which

21 such entity will pay the cost of the services provided.

22 Amounts received by the Director under such arrangements

23 shall be available to the Director for obligation until ex24 pended.
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1 ‘‘SEC. 924. DISSEMINATION OF INFORMATION.

2 ‘‘(a) IN GENERAL.—The Director shall—

3 ‘‘(1) without regard to section 501 of title 44,

4 United States Code, promptly publish, make avail5 able, and otherwise disseminate, in a form under6 standable and on as broad a basis as practicable so

7 as to maximize its use, the results of research, dem8 onstration projects, and evaluations conducted or sup9 ported under this title;

10 ‘‘(2) ensure that information disseminated by the

11 Agency is science-based and objective and undertakes

12 consultation as necessary to assess the appropriate13 ness and usefulness of the presentation of information

14 that is targeted to specific audiences;

15 ‘‘(3) promptly make available to the public data

16 developed in such research, demonstration projects,

17 and evaluations;

18 ‘‘(4) provide, in collaboration with the National

19 Library of Medicine where appropriate, indexing, ab20 stracting, translating, publishing, and other services

21 leading to a more effective and timely dissemination

22 of information on research, demonstration projects,

23 and evaluations with respect to healthcare to public

24 and private entities and individuals engaged in the

25 improvement of healthcare delivery and the general

26 public, and undertake programs to develop new or
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1 improved methods for making such information avail2 able; and

3 ‘‘(5) as appropriate, provide technical assistance

4 to State and local government and health agencies

5 and conduct liaison activities to such agencies to fos6 ter dissemination.

7 ‘‘(b) PROHIBITION AGAINST RESTRICTIONS.—Except

8 as provided in subsection (c), the Director may not restrict

9 the publication or dissemination of data from, or the results

10 of, projects conducted or supported under this title.

11 ‘‘(c) LIMITATION ON USE OF CERTAIN INFORMA12 TION.—No information, if an establishment or person sup13 plying the information or described in it is identifiable, ob14 tained in the course of activities undertaken or supported

15 under this title may be used for any purpose other than

16 the purpose for which it was supplied unless such establish17 ment or person has consented (as determined under regula18 tions of the Director) to its use for such other purpose. Such

19 information may not be published or released in other form

20 if the person who supplied the information or who is de21 scribed in it is identifiable unless such person has consented

22 (as determined under regulations of the Director) to its pub23 lication or release in other form.

24 ‘‘(d) PENALTY.—Any person who violates subsection

25 (c) shall be subject to a civil monetary penalty of not more
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1 than $10,000 for each such violation involved. Such penalty

2 shall be imposed and collected in the same manner as civil

3 money penalties under subsection (a) of section 1128A of

4 the Social Security Act are imposed and collected.

5 ‘‘SEC. 925. ADDITIONAL PROVISIONS WITH RESPECT TO

6 GRANTS AND CONTRACTS.

7 ‘‘(a) FINANCIAL CONFLICTS OF INTEREST.—With re8 spect to projects for which awards of grants, cooperative

9 agreements, or contracts are authorized to be made under

10 this title, the Director shall by regulation define—

11 ‘‘(1) the specific circumstances that constitute fi12 nancial interests in such projects that will, or may be

13 reasonably expected to, create a bias in favor of ob14 taining results in the projects that are consistent with

15 such interests; and

16 ‘‘(2) the actions that will be taken by the Direc17 tor in response to any such interests identified by the

18 Director.

19 ‘‘(b) REQUIREMENT OF APPLICATION.—The Director

20 may not, with respect to any program under this title au21 thorizing the provision of grants, cooperative agreements,

22 or contracts, provide any such financial assistance unless

23 an application for the assistance is submitted to the Sec24 retary and the application is in such form, is made in such

25 manner, and contains such agreements, assurances, and in-
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1 formation as the Director determines to be necessary to

2 carry out the program in involved.

3 ‘‘(c) PROVISION OF SUPPLIES AND SERVICES IN LIEU

4 OF FUNDS.—

5 ‘‘(1) IN GENERAL.—Upon the request of an enti6 ty receiving a grant, cooperative agreement, or con7 tract under this title, the Secretary may, subject to

8 paragraph (2), provide supplies, equipment, and serv9 ices for the purpose of aiding the entity in carrying

10 out the project involved and, for such purpose, may

11 detail to the entity any officer or employee of the De12 partment of Health and Human Services.

13 ‘‘(2) CORRESPONDING REDUCTION IN FUNDS.—

14 With respect to a request described in paragraph (1),

15 the Secretary shall reduce the amount of the financial

16 assistance involved by an amount equal to the costs

17 of detailing personnel and the fair market value of

18 any supplies, equipment, or services provided by the

19 Director. The Secretary shall, for the payment of ex20 penses incurred in complying with such request, ex21 pend the amounts withheld.

22 ‘‘(d) APPLICABILITY OF CERTAIN PROVISIONS WITH

23 RESPECT TO CONTRACTS.—Contracts may be entered into

24 under this part without regard to sections 3648 and 3709

25 of the Revised Statutes (31 U.S.C. 529; 41 U.S.C. 5).
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1 ‘‘SEC. 926. CERTAIN ADMINISTRATIVE AUTHORITIES.

2 ‘‘(a) DEPUTY DIRECTOR AND OTHER OFFICERS AND

3 EMPLOYEES.—

4 ‘‘(1) DEPUTY DIRECTOR.—The Director may ap5 point a deputy director for the Agency.

6 ‘‘(2) OTHER OFFICERS AND EMPLOYEES.—The

7 Director may appoint and fix the compensation of

8 such officers and employees as may be necessary to

9 carry out this title. Except as otherwise provided by

10 law, such officers and employees shall be appointed in

11 accordance with the civil service laws and their com12 pensation fixed in accordance with title 5, United

13 States Code.

14 ‘‘(b) FACILITIES.—The Secretary, in carrying out this

15 title—

16 ‘‘(1) may acquire, without regard to the Act of

17 March 3, 1877 (40 U.S.C. 34), by lease or otherwise

18 through the Director of General Services, buildings or

19 portions of buildings in the District of Columbia or

20 communities located adjacent to the District of Co21 lumbia for use for a period not to exceed 10 years;

22 and

23 ‘‘(2) may acquire, construct, improve, repair, op24 erate, and maintain laboratory, research, and other

25 necessary facilities and equipment, and such other
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1 real or personal property (including patents) as the

2 Secretary deems necessary.

3 ‘‘(c) PROVISION OF FINANCIAL ASSISTANCE.—The Di4 rector, in carrying out this title, may make grants to public

5 and nonprofit entities and individuals, and may enter into

6 cooperative agreements or contracts with public and private

7 entities and individuals.

8 ‘‘(d) UTILIZATION OF CERTAIN PERSONNEL AND RE9 SOURCES.—

10 ‘‘(1) DEPARTMENT OF HEALTH AND HUMAN

11 SERVICES.—The Director, in carrying out this title,

12 may utilize personnel and equipment, facilities, and

13 other physical resources of the Department of Health

14 and Human Services, permit appropriate (as deter15 mined by the Secretary) entities and individuals to

16 utilize the physical resources of such Department, and

17 provide technical assistance and advice.

18 ‘‘(2) OTHER AGENCIES.—The Director, in car19 rying out this title, may use, with their consent, the

20 services, equipment, personnel, information, and fa21 cilities of other Federal, State, or local public agen22 cies, or of any foreign government, with or without

23 reimbursement of such agencies.

24 ‘‘(e) CONSULTANTS.—The Secretary, in carrying out

25 this title, may secure, from time to time and for such peri-
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1 ods as the Director deems advisable but in accordance with

2 section 3109 of title 5, United States Code, the assistance

3 and advice of consultants from the United States or abroad.

4 ‘‘(f) EXPERTS.—

5 ‘‘(1) IN GENERAL.—The Secretary may, in car6 rying out this title, obtain the services of not more

7 than 50 experts or consultants who have appropriate

8 scientific or professional qualifications. Such experts

9 or consultants shall be obtained in accordance with

10 section 3109 of title 5, United States Code, except that

11 the limitation in such section on the duration of serv12 ice shall not apply.

13 ‘‘(2) TRAVEL EXPENSES.—

14 ‘‘(A) IN GENERAL.—Experts and consult15 ants whose services are obtained under para16 graph (1) shall be paid or reimbursed for their

17 expenses associated with traveling to and from

18 their assignment location in accordance with sec19 tions 5724, 5724a(a), 5724a(c), and 5726(C) of

20 title 5, United States Code.

21 ‘‘(B) LIMITATION.—Expenses specified in

22 subparagraph (A) may not be allowed in connec23 tion with the assignment of an expert or consult24 ant whose services are obtained under paragraph

25 (1) unless and until the expert agrees in writing
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1 to complete the entire period of assignment, or

2 1 year, whichever is shorter, unless separated or

3 reassigned for reasons that are beyond the con4 trol of the expert or consultant and that are ac5 ceptable to the Secretary. If the expert or consult6 ant violates the agreement, the money spent by

7 the United States for the expenses specified in

8 subparagraph (A) is recoverable from the expert

9 or consultant as a statutory obligation owed to

10 the United States. The Secretary may waive in

11 whole or in part a right of recovery under this

12 subparagraph.

13 ‘‘(g) VOLUNTARY AND UNCOMPENSATED SERVICES.—

14 The Director, in carrying out this title, may accept vol15 untary and uncompensated services.

16 ‘‘SEC. 927. FUNDING.

17 ‘‘(a) INTENT.—To ensure that the United States’s in18 vestment in biomedical research is rapidly translated into

19 improvements in the quality of patient care, there must be

20 a corresponding investment in research on the most effective

21 clinical and organizational strategies for use of these find22 ings in daily practice. The authorization levels in sub23 section (b) provide for a proportionate increase in

24 healthcare research as the United States investment in bio25 medical research increases.
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1 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—For the

2 purpose of carrying out this title, there are authorized to

3 be appropriated $250,000,000 for fiscal year 2000, and such

4 sums as may be necessary for each of the fiscal years 2001

5 through 2006.

6 ‘‘(c) EVALUATIONS.—In addition to amounts available

7 pursuant to subsection (b) for carrying out this title, there

8 shall be made available for such purpose, from the amounts

9 made available pursuant to section 241 (relating to evalua10 tions), an amount equal to 40 percent of the maximum

11 amount authorized in such section 241 to be made available

12 for a fiscal year.

13 ‘‘SEC. 928. DEFINITIONS.

14 ‘‘In this title:

15 ‘‘(1) ADVISORY COUNCIL.—The term ‘Advisory

16 Council’ means the Advisory Council on Healthcare

17 Research and Quality established under section 921.

18 ‘‘(2) AGENCY.—The term ‘Agency’ means the

19 Agency for Healthcare Research and Quality.

20 ‘‘(3) DIRECTOR.—The term ‘Director’ means the

21 Director for the Agency for Healthcare Research and

22 Quality.’’.

23 SEC. 303. REFERENCES.

24 Effective upon the date of enactment of this Act, any

25 reference in law to the ‘‘Agency for Health Care Policy and
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1 Research’’ shall be deemed to be a reference to the ‘‘Agency

2 for Healthcare Research and Quality’’.

3 TITLE IV—MISCELLANEOUS

4 PROVISIONS

5 SEC. 401. SENSE OF THE COMMITTEE.

6 It is the sense of the Committee on Health, Education,

7 Labor, and Pensions of the Senate that the Congress should

8 take measures to further the purposes of this Act, including

9 any necessary changes to the Internal Revenue Code of 1986

10 or to other Acts to—

11 (1) promote equity and prohibit discrimination

12 based on genetic information with respect to the

13 availability of health benefits;

14 (2) provide for the full deduction of health insur15 ance costs for self-employed individuals;

16 (3) provide for the full availability of medical

17 savings accounts;

18 (4) provide for the carryover of unused benefits

19 from cafeteria plans, flexible spending arrangements,

20 and health flexible spending accounts; and

21 (5) permit contributions towards medical sav22 ings account through the Federal employees health

23 benefits program.