II

106TH CONGRESS

1ST SESSION S. 326

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, and Mr. SESSIONS)

introduced the following bill; which was read twice and referred to the

Committee on Health, Education, Labor, and Pensions

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’’.

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

7 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
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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

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.
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‘‘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—

9 (1) by redesignating subpart C as subpart D;

10 and

11 (2) by inserting after subpart B the following:
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1 ‘‘Subpart C—Patient Right to Medical Advice and

2 Care

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

4 CARE.

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

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

7 provides coverage for benefits consisting of emergency

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

9 items or services specifically excluded—

10 ‘‘(1) the plan shall provide coverage for bene11 fits, without requiring preauthorization, for appro12 priate emergency medical screening examinations

13 (within the capability of the emergency facility, in14 cluding ancillary services routinely available to the

15 emergency facility) to the extent that a prudent

16 layperson, who possesses an average knowledge of

17 health and medicine, would determine such examina18 tions to be necessary to determine whether emer19 gency medical care (as so defined) is necessary, and

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

21 for additional emergency medical care to stabilize an

22 emergency medical condition following an emergency

23 medical screening examination (if determined nec24 essary under paragraph (1)), pursuant to the defini25 tion of stabilize under section 1867(e)(3) of the So26 cial Security Act (42 U.S.C. 1395dd(e)(3)).
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1 ‘‘(b) UNIFORM COST-SHARING REQUIRED.—Nothing

2 in this section shall be construed as preventing a group

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

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

5 participant or beneficiary (including coinsurance, copay6 ments, deductibles, and any other charges) in relation to

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

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

9 with respect to similarly situated participants and bene10 ficiaries, to all benefits consisting of emergency medical

11 care (as defined in subsection (c)) provided to such simi12 larly situated participants and beneficiaries under the

13 plan.

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

15 In this section:

16 ‘‘(1) IN GENERAL.—The term ‘‘emergency med17 ical care’’ means, with respect to a participant or

18 beneficiary under a group health plan (other than a

19 fully insured group health plan), covered inpatient

20 and outpatient services that—

21 ‘‘(A) are furnished by any provider, includ22 ing a nonparticipating provider, that is qualified

23 to furnish such services; and

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

25 such term is defined in section 1867(e)(3) of
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1 the Social Security Act (42 U.S.C. 1395dd)) an

2 emergency medical condition (as defined in

3 paragraph (2)).

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

5 term ‘‘emergency medical condition’’ means a medi6 cal condition manifesting itself by acute symptoms

7 of sufficient severity (including severe pain) such

8 that a prudent layperson, who possesses an average

9 knowledge of health and medicine, could reasonably

10 expect the absence of immediate medical attention to

11 result in—

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

13 or beneficiary (or, with respect to a pregnant

14 woman, the health of the woman or her unborn

15 child) in serious jeopardy,

16 ‘‘(B) serious impairment to bodily func17 tions, or

18 ‘‘(C) serious dysfunction of any bodily

19 organ or part.

20 ‘‘SEC. 722. OFFERING OF CHOICE OF COVERAGE OPTIONS.

21 ‘‘(a) REQUIREMENT.—

22 ‘‘(1) OFFERING OF POINT-OF-SERVICE COV23 ERAGE OPTION.—Except as provided in paragraph

24 (2), if a group health plan (other than a fully in25 sured group health plan) provides coverage for bene-
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1 fits only through a defined set of participating

2 health care professionals, the plan shall offer the

3 participant the option to purchase point-of-service

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

5 benefits for which coverage is otherwise so limited.

6 Such option shall be made available to the partici7 pant at the time of enrollment under the plan and

8 at such other times as the plan offers the participant

9 a choice of coverage options.

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

11 ISSUER OR COVERAGE OPTIONS.—Paragraph (1)

12 shall not apply with respect to a participant in a

13 group health plan (other than a fully insured group

14 health plan) if the plan offers the participant—

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

16 through more than one health insurance issuer;

17 or

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

19 differ significantly with respect to the use of

20 participating health care professionals or the

21 networks of such professionals that are used.

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

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

24 with respect to benefits covered under a group health plan

25 (other than a fully insured group health plan), coverage
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1 of such benefits when provided by a nonparticipating

2 health care professional.

3 ‘‘(c) SMALL EMPLOYER EXEMPTION.—

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

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

6 group health plan) of a small employer.

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

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

9 connection with a group health plan (other than a

10 fully insured group health plan) with respect to a

11 calendar year and a plan year, an employer who em12 ployed an average of at least 2 but not more than

13 50 employees on business days during the preceding

14 calendar year and who employs at least 2 employees

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

16 this paragraph, the provisions of subparagraph (C)

17 of section 712(c)(1) shall apply in determining em18 ployer size.

19 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec20 tion shall be construed—

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

22 particular type of health care professional;

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

24 as a result of this section or to make equal contribu-
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1 tions with respect to different health coverage op2 tions;

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

4 than a fully insured group health plan) from impos5 ing higher premiums or cost-sharing on a partici6 pant for the exercise of a point-of-service coverage

7 option; or

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

9 than a fully insured group health plan) include cov10 erage of health care professionals that the plan ex11 cludes because of fraud, quality of care, or other

12 similar reasons with respect to such professionals.

13 ‘‘SEC. 723. PATIENT ACCESS TO OBSTETRIC AND GYNECO14 LOGICAL CARE.

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

16 health plan (other than a fully insured group health

17 plan)—

18 ‘‘(1) provides coverage for benefits consisting

19 of—

20 ‘‘(A) gynecological care (such as preventive

21 women’s health examinations); or

22 ‘‘(B) obstetric care (such as pregnancy-re23 lated services);

24 provided by a participating physician who specializes

25 in such care; and
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1 ‘‘(2) requires or provides for designation by a

2 participant or beneficiary of a participating primary

3 care provider;

4 if the primary care provider designated by such a partici5 pant or beneficiary is not such a physician as described

6 in paragraph (1), then the plan shall meet the require7 ments of subsection (b).

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

9 than a fully insured group health plan) meets the require10 ments of this subsection, in connection with the coverage

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

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

13 if the plan—

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

15 by the primary care provider in order to obtain cov16 erage for such benefits, and

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

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

19 (B) of subsection (a)(1), by the participating physi20 cian providing the care described in either such sub21 paragraph, as the authorization of the primary care

22 provider with respect to such care.

23 ‘‘(c) RULE OF CONSTRUCTION.—Nothing in sub24 section (b)(2) shall waive any requirements of coverage re25 lating to medical necessity or appropriateness with respect
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1 to coverage of gynecological or obstetric care so ordered.

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

3 the health plan from requiring that the obstetrician or

4 gynecologist notify the primary care provider or the plan

5 of treatment decisions.

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

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

8 health plan (other than a fully insured group health

9 plan)—

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

11 pediatric care by a participating pediatrician; and

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

13 participant or beneficiary of a participating primary

14 care provider;

15 if the primary care provider designated by such a partici16 pant or beneficiary is not a physician as described in para17 graph (1), then the plan shall meet the requirements of

18 subsection (b).

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

20 than a fully insured group health plan) meets the require21 ments of this subsection, in connection with the coverage

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

23 described in subsection (a)(1), if the plan—
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1 ‘‘(1) does not require authorization or a referral

2 by the primary care provider in order to obtain cov3 erage for such benefits, and

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

5 the same type, by the participating physician provid6 ing the care described in subsection (a)(1), as the

7 authorization of the primary care provider with re8 spect to such care.

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

10 shall waive any requirements of coverage relating to medi11 cal necessity or appropriateness with respect to coverage

12 of pediatric care so ordered.

13 ‘‘SEC. 725. CONTINUITY OF CARE.

14 ‘‘(a) IN GENERAL.—

15 ‘‘(1) TERMINATION OF PROVIDER.—If a con16 tract between a group health plan (other than a fully

17 insured group health plan) and a health care pro18 vider is terminated (as defined in paragraph (2)), or

19 benefits or coverage provided by a health care pro20 vider are terminated because of a change in the

21 terms of provider participation in such group health

22 plan, and an individual who is a participant or bene23 ficiary in the plan is undergoing a course of treat24 ment from the provider at the time of such termi25 nation, the plan shall—
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1 ‘‘(A) notify the individual on a timely basis

2 of such termination;

3 ‘‘(B) provide the individual with an oppor4 tunity to notify the plan of a need for transi5 tional care; and

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

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

8 and subject to subsection (c), permit the indi9 vidual to continue or be covered with respect to

10 the course of treatment with the provider’s con11 sent during a transitional period (as provided

12 under subsection (b)).

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

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

15 expiration or nonrenewal of the contract by the

16 group health plan, but does not include a termi17 nation of the contract by the plan for failure to meet

18 applicable quality standards or for fraud.

19 ‘‘(3) CONTRACTS.—For purposes of this sec20 tion, the term ‘contract between a group health plan

21 (other than a fully insured group health plan) and

22 a health care provider’ shall include a contract be23 tween such a plan and an organized network of pro24 viders.

25 ‘‘(b) TRANSITIONAL PERIOD.—
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1 ‘‘(1) GENERAL RULE.—Except as provided in

2 paragraph (3), the transitional period under this

3 subsection shall extend for up to 90 days from the

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

5 of the provider’s termination.

6 ‘‘(2) INSTITUTIONAL CARE.—Subject to para7 graph (1), the transitional period under this sub8 section for institutional or inpatient care from a pro9 vider shall extend until the discharge or termination

10 of the period of institutionalization and also shall in11 clude institutional care provided within a reasonable

12 time of the date of termination of the provider sta13 tus if the care was scheduled before the date of the

14 announcement of the termination of the provider

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

16 on such date was on an established waiting list or

17 otherwise scheduled to have such care.

18 ‘‘(3) PREGNANCY.—Notwithstanding paragraph

19 (1), if—

20 ‘‘(A) a participant or beneficiary has en21 tered the second trimester of pregnancy at the

22 time of a provider’s termination of participa23 tion; and

24 ‘‘(B) the provider was treating the preg25 nancy before the date of the termination;
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1 the transitional period under this subsection with re2 spect to provider’s treatment of the pregnancy shall

3 extend through the provision of post-partum care di4 rectly related to the delivery.

5 ‘‘(4) TERMINAL ILLNESS.—Subject to para6 graph (1), if—

7 ‘‘(A) a participant or beneficiary was de8 termined to be terminally ill (as determined

9 under section 1861(dd)(3)(A) of the Social Se10 curity Act) prior to a provider’s termination of

11 participation; and

12 ‘‘(B) the provider was treating the termi13 nal illness before the date of termination;

14 the transitional period under this subsection shall be

15 for care directly related to the treatment of the ter16 minal illness.

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

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

19 plan) may condition coverage of continued treatment by

20 a provider under subsection (a)(1)(B) upon the provider

21 agreeing to the following terms and conditions:

22 ‘‘(1) The provider agrees to accept reimburse23 ment from the plan and individual involved (with re24 spect to cost-sharing) at the rates applicable prior to

25 the start of the transitional period as payment in
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1 full (or, in the case described in subsection (b)(2),

2 at the rates applicable under the replacement plan

3 after the date of the termination of the contract with

4 the group health plan) and not to impose cost-shar5 ing with respect to the individual in an amount that

6 would exceed the cost-sharing that could have been

7 imposed if the contract referred to in subsection

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

9 ‘‘(2) The provider agrees to adhere to the qual10 ity assurance standards of the plan responsible for

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

12 plan necessary medical information related to the

13 care provided.

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

15 such plan’s policies and procedures, including proce16 dures regarding referrals and obtaining prior au17 thorization and providing services pursuant to a

18 treatment plan (if any) approved by the plan.

19 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec20 tion shall be construed to require the coverage of benefits

21 which would not have been covered if the provider involved

22 remained a participating provider.

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

24 care provider’ or ‘provider’ means—
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1 ‘‘(1) any individual who is engaged in the deliv2 ery of health care services in a State and who is re3 quired by State law or regulation to be licensed or

4 certified by the State to engage in the delivery of

5 such services in the State; and

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

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

8 required by State law or regulation to be licensed or

9 certified by the State to engage in the delivery of

10 such services in the State, is so licensed.

11 ‘‘SEC. 726. PROTECTION OF PATIENT-PROVIDER COMMU12 NICATIONS.

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

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

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

16 not prohibit or otherwise restrict a health care professional

17 from advising such a participant or beneficiary who is a

18 patient of the professional about the health status of the

19 participant or beneficiary or medical care or treatment for

20 the condition or disease of the participant or beneficiary,

21 regardless of whether coverage for such care or treatment

22 are provided under the contract, if the professional is act23 ing within the lawful scope of practice.

24 ‘‘(b) RULE OF CONSTRUCTION.—Nothing in this sec25 tion shall be construed as requiring a group health plan
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1 (other than a fully insured group health plan) to provide

2 specific benefits under the terms of such plan.

3 ‘‘SEC. 727. GENERALLY APPLICABLE PROVISION.

4 ‘‘In the case of a group health plan that provides ben5 efits under 2 or more coverage options, the requirements

6 of sections 721, 723, 724, 725 and 726 shall apply sepa7 rately with respect to each coverage option.’’.

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

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

10 1186(a)) is amended by adding at the end the following:

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

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

13 group health plan where benefits are provided pursu14 ant to the terms of an arrangement between a group

15 health plan and a health insurance issuer and are

16 guaranteed by the health insurance issuer under a

17 contract or policy of insurance.’’.

18 (c) CONFORMING AMENDMENT.—The table of con19 tents in section 1 of such Act is amended—

20 (1) in the item relating to subpart C, by strik21 ing ‘‘Subpart C’’ and inserting ‘‘Subpart D’’; and

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

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

24 Act the following new items:

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

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

1 SEC. 102. EFFECTIVE DATE AND RELATED RULES.

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

3 subtitle shall apply with respect to plan years beginning

4 on or after January 1 of the second calendar year follow5 ing the date of the enactment of this Act. The Secretary

6 shall issue all regulations necessary to carry out the

7 amendments made by this section before the effective date

8 thereof.

9 (b) LIMITATION ON ENFORCEMENT ACTIONS.—No

10 enforcement action shall be taken, pursuant to the amend11 ments made by this subtitle, against a group health plan

12 with respect to a violation of a requirement imposed by

13 such amendments before the date of issuance of regula14 tions issued in connection with such requirement, if the

15 plan has sought to comply in good faith with such require16 ment.

17 Subtitle B—Right to Information

18 About Plans and Providers

19 SEC. 111. INFORMATION ABOUT PLANS.

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

21 B of title I of the Employee Retirement Income Security

22 Act of 1974, as amended by the Omnibus Consolidated
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1 and Emergency Supplemental Appropriations Act, 1999

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

3 the following:

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

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

6 insurance issuer in connection with group health insurance

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

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

9 in a clear and accurate form to each enrollee, or upon re10 quest to a potential enrollee eligible to receive benefits

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

12 issuer has contracted, of the information described in sub13 section (b).

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

15 materials to be distributed under this section shall include

16 for each health benefit plan the following:

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

18 services under each such plan and any in- and out19 of-network features of each such plan.

20 ‘‘(2) A description of any cost-sharing, includ21 ing premiums, deductibles, coinsurance, and copay22 ment amounts, for which the enrollee will be respon23 sible, including any annual or lifetime limits on ben24 efits, 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

3 and conditions (including premiums or cost-sharing)

4 for such supplemental coverage.

5 ‘‘(4) A description of any restrictions on pay6 ments for services furnished to an enrollee by a

7 health care professional that is not a participating

8 professional and the liability of the enrollee for addi9 tional payments for these services.

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

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

12 coverage.

13 ‘‘(6) A description of the extent to which enroll14 ees may select the primary care provider of their

15 choice, including providers both within the network

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

17 plan permits out-of-network services).

18 ‘‘(7) A description of the procedures for ad19 vance directives and organ donation decisions if the

20 plan maintains such procedures.

21 ‘‘(8) A description of the requirements and pro22 cedures to be used to obtain preauthorization for

23 health services (including telephone numbers and

24 mailing addresses), including referrals for specialty

25 care.
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1 ‘‘(9) A summary of the rules and methods for

2 appealing coverage decisions and filing grievances

3 (including telephone numbers and mailing address4 es), as well as other available remedies.

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

6 emergency room care. Also, any available edu7 cational material regarding proper use of emergency

8 services.

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

10 is provided for experimental treatments, investiga11 tional treatments, or clinical trials and the cir12 cumstances under which access to such treatments

13 or trials is made available.

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

15 services covered under the plan if such services are

16 covered.

17 ‘‘(13) A statement regarding—

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

19 access an obstetrician, gynecologist, or pediatri20 cian in accordance with section 723 or 724;

21 ‘‘(B) the manner in which an enrollee ob22 tains continuity of care as provided for in sec23 tion 725; and

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

25 access to the medical records of the enrollee in
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1 accordance with subtitle A of title II of the Pa2 tients’ Bill of Rights Act.

3 ‘‘(14) A statement that the following informa4 tion, and instructions on obtaining such information

5 (including telephone numbers and, if available,

6 Internet websites), shall be made available upon re7 quest:

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

9 numbers, and State licensure status of the

10 plan’s participating health care professionals

11 and participating health care facilities, and, if

12 available, the education, training, speciality

13 qualifications or certifications of such profes14 sionals.

15 ‘‘(B) A summary description of the meth16 ods used for compensating participating health

17 care professionals, such as capitation, fee-for18 service, salary, or a combination thereof. The

19 requirement of this subparagraph shall not be

20 construed as requiring plans to provide infor21 mation concerning proprietary payment meth22 odology.

23 ‘‘(C) A summary description of the meth24 ods used for compensating health care facilities,

25 including per diem, fee-for-service, capitation,
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1 bundled payments, or a combination thereof.

2 The requirement of this subparagraph shall not

3 be construed as requiring plans to provide in4 formation concerning proprietary payment

5 methodology.

6 ‘‘(D) A summary description of the proce7 dures used for utilization review.

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

9 medications included in the formulary of the

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

11 any provision for obtaining off-formulary medi12 cations.

13 ‘‘(F) A description of the specific exclu14 sions 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

23 accreditation if the plan is accredited, or any

24 additional quality indicators that the plan

25 makes available.
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1 ‘‘(c) MANNER OF DISTRIBUTION.—

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

3 in this section shall be distributed in an accessible

4 format that is understandable to an average plan en5 rollee.

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

7 of this section, a group health plan, or health insur8 ance issuer in connection with group health insur9 ance coverage, in reliance on records maintained by

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

11 requirements of this section if the plan or issuer pro12 vides the information requested under this section—

13 ‘‘(A) in the case of the plan, to partici14 pants and beneficiaries at the address contained

15 in such records with respect to such partici16 pants and beneficiaries; or

17 ‘‘(B) in the case of the issuer, to the em18 ployer of a participant if the employer provides

19 for the coverage of such participant under the

20 plan involved or to participants and bene21 ficiaries at the address contained in such

22 records with respect to such participants and

23 beneficiaries.

24 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec25 tion may be construed to prohibit a group health plan,
26

•S 326 IS

1 or health insurance issuer in connection with group health

2 insurance coverage, from distributing any other additional

3 information determined by the plan or issuer to be impor4 tant or necessary in assisting participants and bene5 ficiaries enrollees or upon request potential participants

6 in the selection of a health plan or from providing informa7 tion under subsection (b)(13) as part of the required infor8 mation.

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

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

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

12 other health care professional if coverage for the profes13 sional’s services is provided under the health plan involved

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

15 podiatrist, optometrist, chiropractor, psychologist, dentist,

16 physician assistant, physical or occupational therapist and

17 therapy assistant, speech-language pathologist, audiol18 ogist, registered or licensed practical nurse (including

19 nurse practitioner, clinical nurse specialist, certified reg20 istered nurse anesthetist, and certified nurse-midwife), li21 censed certified social worker, registered respiratory thera22 pist, and certified respiratory therapy technician.’’.

23 (b) CONFORMING AMENDMENTS.—

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

25 Income Security Act of 1974 (29 U.S.C. 1185(a)) is
27

•S 326 IS

1 amended by striking ‘‘section 711, and inserting

2 ‘‘sections 711 and 714’’.

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

4 Employee Retirement Income Security Act of 1974

5 (29 U.S.C. 1001) is amended by inserting after the

6 item relating to section 713, the following:

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

7 SEC. 112. INFORMATION ABOUT PROVIDERS.

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

9 Services shall enter into a contract with the Institute of

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

11 to the Secretary of a report, that includes—

12 (1) an analysis of information concerning health

13 care professionals that is currently available to pa14 tients, consumers, States, and professional societies,

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

16 patient preferences with respect to information

17 about such professionals and their competencies;

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

19 to the sharing of information concerning health care

20 professionals; and

21 (3) recommendations for the disclosure of infor22 mation on health care professionals, including the

23 competencies and professional qualifications of such

24 practitioners, to better facilitate patient choice, qual25 ity improvement, and market competition.
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1 (b) REPORT.—Not later than 18 months after the

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

3 Human Services shall forward to the appropriate commit4 tees of Congress a copy of the report and study conducted

5 under subsection (a).

6 Subtitle C—Right to Hold Health

7 Plans Accountable

8 SEC. 121. AMENDMENT TO EMPLOYEE RETIREMENT IN9 COME SECURITY ACT OF 1974.

10 (a) IN GENERAL.—Section 503 of the Employee Re11 tirement Income Security Act of 1974 (29 U.S.C. 1133)

12 is amended to read as follows:

13 ‘‘SEC. 503. CLAIMS PROCEDURE, COVERAGE DETERMINA14 TION, GRIEVANCES AND APPEALS.

15 ‘‘(a) CLAIMS PROCEDURE.—In accordance with regu16 lations of the Secretary, every employee benefit plan

17 shall—

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

19 participant or beneficiary whose claim for benefits

20 under the plan has been denied, setting forth the

21 specific reasons for such denial, written in a manner

22 calculated to be understood by the participant, and

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

24 participant whose claim for benefits has been denied
29

•S 326 IS

1 for a full and fair review by the appropriate named

2 fiduciary of the decision denying the claim.

3 ‘‘(b) COVERAGE DETERMINATIONS UNDER GROUP

4 HEALTH PLANS.—

5 ‘‘(1) PROCEDURES.—

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

7 or health insurance issuer conducting utilization

8 review shall ensure that procedures are in place

9 for—

10 ‘‘(i) making determinations regarding

11 whether an enrollee is eligible to receive a

12 payment or coverage for health services

13 under the plan or coverage involved and

14 any cost-sharing amount that the enrollee

15 is required to pay with respect to such

16 service;

17 ‘‘(ii) notifying covered enrollees (or

18 the legal representative of such enrollees)

19 and the treating health care professionals

20 involved regarding determinations made

21 under the plan or issuer and any addi22 tional payments that the enrollee may be

23 required to make with respect to such serv24 ice; and
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•S 326 IS

1 ‘‘(iii) responding to requests, either

2 written or oral, for coverage determina3 tions or for internal appeals from an en4 rollee (or the legal representative of such

5 enrollee) or the treating health care profes6 sional.

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

8 an oral request described in subparagraph

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

10 issuer may require that the requesting individ11 ual provide written evidence of such request.

12 ‘‘(2) TIMELINE FOR MAKING DETERMINA13 TIONS.—

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

15 health plan or a health insurance issuer shall

16 maintain procedures to ensure that prior au17 thorization determinations concerning the provi18 sion of non-emergency items or services are

19 made within 30 days from the date on which

20 the request for a determination is submitted,

21 except that such period may be extended where

22 certain circumstances exist that are determined

23 by the Secretary to be beyond control of the

24 plan or issuer.

25 ‘‘(B) EXPEDITED DETERMINATION.—
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1 ‘‘(i) IN GENERAL.—A prior authoriza2 tion determination under this subsection

3 shall be made within 72 hours after a re4 quest is received by the plan or issuer

5 under clause (ii) or (iii).

6 ‘‘(ii) REQUEST BY ENROLLEE.—A

7 plan or issuer shall maintain procedures

8 for expediting a prior authorization deter9 mination under this subsection upon the

10 request of an enrollee if, based on such a

11 request, the plan or issuer determines that

12 the normal time for making such a deter13 mination could seriously jeopardize the life

14 or health of the enrollee.

15 ‘‘(iii) DOCUMENTATION BY HEALTH

16 CARE PROFESSIONAL.—A plan or issuer

17 shall maintain procedures for expediting a

18 prior authorization determination under

19 this subsection if the request involved indi20 cates that the treating health care profes21 sional has documented, based on the medi22 cal exigencies, that a determination under

23 the procedures described in subparagraph

24 (A) could seriously jeopardize the life or

25 health of the enrollee.
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1 ‘‘(C) CONCURRENT DETERMINATIONS.—A

2 plan or issuer shall maintain procedures to cer3 tify or deny coverage of an extended stay or ad4 ditional services.

5 ‘‘(D) RETROSPECTIVE DETERMINATION.—

6 A plan or issuer shall maintain procedures to

7 ensure that, with respect to the retrospective re8 view of a determination made under paragraph

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

10 working days of the date on which the plan or

11 issuer receives all necessary information.

12 ‘‘(3) NOTICE OF DETERMINATIONS.—

13 ‘‘(A) ROUTINE DETERMINATION.—With re14 spect to a coverage determination of a plan or

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

16 issuer shall issue notice of such determination

17 to the enrollee (or the legal representative of

18 the enrollee), and consistent with the medical

19 exigencies of the case, to the treating health

20 care professional involved not later than 2

21 working days after the date on which the deter22 mination is made.

23 ‘‘(B) EXPEDITED DETERMINATION.—With

24 respect to a coverage determination of a plan or

25 issuer under paragraph (2)(B), the plan or
33

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1 issuer shall issue notice of such determination

2 to the enrollee (or the legal representative of

3 the enrollee), and consistent with the medical

4 exigencies of the case, to the treating health

5 care professional involved within the 72 hour

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

7 ‘‘(C) CONCURRENT REVIEWS.—With re8 spect to the determination under a plan or

9 issuer under paragraph (1) to certify or deny

10 coverage of an extended stay or additional serv11 ices, the plan or issuer shall issue notice of such

12 determination to the treating health care pro13 fessional and to the enrollee involved (or the

14 legal representative of the enrollee) within 1

15 working day of the date on which the initial no16 tice was issued.

17 ‘‘(D) RETROSPECTIVE REVIEWS.—With re18 spect to the retrospective review under a plan

19 or issuer of a determination made under para20 graph (1), a determination shall be made within

21 30 working days of the date on which the plan

22 or issuer receives all necessary information. The

23 plan or issuer shall issue written notice of an

24 approval or disapproval of a determination

25 under this subparagraph to the enrollee (or the
34

•S 326 IS

1 legal representative of the enrollee) and health

2 care provider involved within 5 working days of

3 the date on which such determination is made.

4 ‘‘(E) REQUIREMENTS OF NOTICE OF AD5 VERSE COVERAGE DETERMINATIONS.—A writ6 ten or electronic notice of an adverse coverage

7 determination under this subsection, or of an

8 expedited adverse coverage determination under

9 paragraph (2)(B), shall be provided to the en10 rollee (or the legal representative of the en11 rollee) and treating health care professional (if

12 any) involved and shall 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 enrollee;

18 ‘‘(ii) the procedures for obtaining ad19 ditional information concerning the deter20 mination; and

21 ‘‘(iii) notification of the right to ap22 peal the determination and instructions on

23 how to initiate an appeal in accordance

24 with subsection (d).
35

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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 and enrollees. Determina4 tions under such procedures shall be non-appealable.

5 ‘‘(d) INTERNAL APPEAL OF COVERAGE DETERMINA6 TIONS.—

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

8 representative of the enrollee) and the treating

9 health care professional with the consent of the en10 rollee (or the legal representative of the enrollee),

11 may appeal any adverse coverage determination

12 under subsection (b) under the procedures described

13 in this subsection.

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

15 health insurance issuer shall maintain written

16 records, for at least 6 years, with respect to any ap17 peal under this subsection for purposes of internal

18 quality assurance and improvement.

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

20 health plan or a health insurance issuer shall provide

21 for the consideration of an appeal of an adverse rou22 tine 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

6 appeal is received by the plan or issuer under

7 subparagraph (B) or (C).

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

9 issuer shall maintain procedures for expediting

10 a prior authorization determination under this

11 subsection upon the request of an enrollee if,

12 based on such a request, the plan or issuer de13 termines that the normal time for making such

14 a determination could seriously jeopardize the

15 life or health of the enrollee.

16 ‘‘(C) DOCUMENTATION BY HEALTH CARE

17 PROFESSIONAL.—A plan or issuer shall main18 tain procedures for expediting a prior author19 ization determination under this subsection if

20 the request involved indicates that the treating

21 health care professional has documented, based

22 on the medical exigencies that a determination

23 under the procedures described in paragraph

24 (2) could seriously jeopardize the life or health

25 of the enrollee.
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1 ‘‘(5) CONDUCT OF REVIEW.—A review of an ad2 verse coverage determination under this subsection

3 shall be conducted by an individual with appropriate

4 expertise who was not involved in the initial deter5 mination.

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

7 of an appeal under this subsection relating to a de8 termination to deny coverage based on a lack of

9 medical necessity or appropriateness, or based on an

10 experimental or investigational treatment, shall be

11 made only by a physician with appropriate expertise

12 in the field of medicine involved who was not in13 volved in the initial determination.

14 ‘‘(7) NOTICE.—

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

16 determination made under an internal review

17 process shall be issued to the enrollee (or the

18 legal representative of the enrollee) and the

19 treating health care professional not later than

20 2 working days after the completion of the re21 view (or within the 72-hour period referred to

22 in paragraph (4) if applicable).

23 ‘‘(B) ADVERSE COVERAGE DETERMINA24 TIONS.—With respect to an adverse coverage

25 determination made under this subsection, the
38

•S 326 IS

1 notice described in subparagraph (A) shall

2 include—

3 ‘‘(i) the reasons for the determination

4 (including the clinical or scientific-evidence

5 based rationale used in making the deter6 mination) written in a manner to be under7 standable to the average enrollee;

8 ‘‘(ii) the procedures for obtaining ad9 ditional information concerning the deter10 mination; and

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

12 external review under subsection (e) and

13 instructions on how to initiate such a re14 view.

15 ‘‘(e) EXTERNAL REVIEW.—

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

17 health insurance issuer shall have written procedures

18 to permit an enrollee (or the legal representative of

19 the enrollee) access to an external review with re20 spect to a coverage determination concerning a par21 ticular item or service where—

22 ‘‘(A) the particular item or service in23 volved, when medically appropriate and nec24 essary, is a covered benefit under the terms and
39

•S 326 IS

1 conditions of the contract between the plan or

2 issuer and the enrollee;

3 ‘‘(B) the coverage determination involved

4 denied coverage for such item or service because

5 the provision of such item or service—

6 ‘‘(i) does not meet the plan’s or

7 issuer’s requirements for medical appro8 priateness or necessity and the amount in9 volved exceeds a significant financial

10 threshold; or

11 ‘‘(ii) would constitute experimental or

12 investigational treatment and there is a

13 significant risk of placing the life or health

14 of the enrollee in jeopardy; and

15 ‘‘(C) the enrollee has completed the inter16 nal appeals process with respect to such deter17 mination.

18 ‘‘(2) INITIATION OF THE EXTERNAL REVIEW

19 PROCESS.—

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

21 (or the legal representative of the enrollee) who

22 desires to have an external review conducted

23 under this subsection shall file a written request

24 for such a review with the plan or issuer in25 volved not later than 30 working days after the
40

•S 326 IS

1 receipt of a final denial of a claim under sub2 section (d). Any such request shall include the

3 consent of the enrollee (or the legal representa4 tive of the enrollee) for the release of medical

5 information and records to external reviewers

6 regarding the enrollee if such information is

7 necessary for the proper conduct of the external

8 review.

9 ‘‘(B) INFORMATION AND NOTICE.—Not

10 later than 5 working days after the receipt of

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

12 accordance with the medical exigencies of the

13 case, the plan or issuer involved shall select an

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

15 that shall be responsible for designating an ex16 ternal reviewer under paragraph (3)(B).

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

18 plan or issuer involved shall forward all nec19 essary information (including medical records,

20 any relevant review criteria, the clinical ration21 ale consistent with the terms and conditions of

22 the contract between the plan or issuer and the

23 enrollee for the coverage denial, and evidence of

24 the enrollee’s coverage) to the external reviewer

25 selected under paragraph (3)(B).
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1 ‘‘(D) NOTIFICATION.—The plan or issuer

2 involved shall send a written notification to the

3 enrollee (or the legal representative of the en4 rollee) and the plan administrator, indicating

5 that an external review has been initiated.

6 ‘‘(3) CONDUCT OF EXTERNAL REVIEW.—

7 ‘‘(A) DESIGNATION OF EXTERNAL AP8 PEALS ENTITY BY PLAN OR ISSUER.—A plan or

9 issuer that receives a request for an external re10 view under paragraph (2)(A) shall designate

11 one of the following entities to serve as the ex12 ternal appeals entity:

13 ‘‘(i) An external review entity licensed

14 or credentialed by a State.

15 ‘‘(ii) A State agency established for

16 the purpose of conducting independent ex17 ternal reviews.

18 ‘‘(iii) Any entity under contract with

19 the Federal Government to provide exter20 nal review services.

21 ‘‘(iv) Any entity accredited as an ex22 ternal review entity by an accrediting body

23 recognized by the Secretary for such pur24 pose.
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1 ‘‘(v) Any fully accredited teaching

2 hospital.

3 ‘‘(vi) Any other entity meeting criteria

4 established by the Secretary for purposes

5 of this subparagraph.

6 ‘‘(B) DESIGNATION OF EXTERNAL RE7 VIEWER BY EXTERNAL APPEALS ENTITY.—The

8 external appeals entity designated under sub9 paragraph (A) shall, not later than 30 days

10 after the date on which such entity is des11 ignated under subparagraph (A), or earlier in

12 accordance with the medical exigencies of the

13 case, designate one or more individuals to serve

14 as external reviewers with respect to a request

15 received under paragraph (2)(A). Such review16 ers shall be independent medical experts who

17 shall—

18 ‘‘(i) be appropriately credentialed or

19 licensed in any State to deliver health care

20 services;

21 ‘‘(ii) not have any material, profes22 sional, familial, or financial affiliation with

23 the case under review, the enrollee in24 volved, the treating health care profes25 sional, the institution where the treatment
43

•S 326 IS

1 would take place, or the manufacturer of

2 any drug, device, procedure, or other ther3 apy proposed for the enrollee whose treat4 ment is under review;

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

6 treatment under review and, when reason7 ably available, be of the same speciality of

8 the physician prescribing the treatment in

9 question;

10 ‘‘(iv) receive only reasonable and cus11 tomary compensation from the group

12 health plan or health insurance issuer in

13 connection with the external review that is

14 not contingent on the decision rendered by

15 the reviewer; and

16 ‘‘(v) not be held liable for decisions re17 garding medical determinations (but may

18 be held liable for actions that are arbitrary

19 and capricious).

20 ‘‘(4) STANDARD OF REVIEW.—

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

22 shall—

23 ‘‘(i) make a determination based on

24 the medical necessity, appropriateness, ex-
44

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1 perimental or investigational nature of the

2 coverage denial;

3 ‘‘(ii) take into consideration any evi4 dence-based decision making or clinical

5 practice guidelines used by the group

6 health plan or health insurance issuer in

7 conducting utilization review; and

8 ‘‘(iii) submit a report on the final de9 terminations of the review involved to—

10 ‘‘(I) the plan or issuer involved;

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

12 legal representative of the enrollee);

13 and

14 ‘‘(III) the health care profes15 sional involved.

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

17 shall ensure that the enrollee receives notice,

18 within 30 days after the determination of the

19 independent medical expert, regarding the ac20 tions of the plan or issuer with respect to the

21 determination of such expert under the external

22 review.

23 ‘‘(5) TIMEFRAME FOR REVIEW.—

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

25 shall complete a review of an adverse coverage
45

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1 determination in accordance with the medical

2 exigencies of the case.

3 ‘‘(B) LIMITATION.—Notwithstanding sub4 paragraph (A), a review described in such sub5 paragraph shall be completed not later than 30

6 working days after the later of—

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

8 is designated; or

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

10 necessary to completing such review is re11 ceived.

12 ‘‘(6) BINDING DETERMINATION.—The deter13 mination of an external reviewer under this sub14 section shall be binding upon the plan or issuer if

15 the provisions of this subsection or the procedures

16 implemented under such provisions were complied

17 with by the external reviewer.

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

19 date of enactment of this section, the General Ac20 counting Office shall conduct a study of a statis21 tically appropriate sample of completed external re22 views. Such study shall include an assessment of the

23 process involved during an external review and the

24 basis of decisionmaking by the external reviewer.
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1 The results of such study shall be submitted to the

2 appropriate committees of Congress.

3 ‘‘(8) EFFECT ON CERTAIN PROVISIONS.—Noth4 ing in this section shall be construed as affecting or

5 modifying section 514 of this Act with respect to a

6 group health plan.

7 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec8 tion shall be construed to prohibit a plan administrator

9 or plan fiduciary or health plan medical director from re10 questing an external review by an external reviewer with11 out first completing the internal review process.

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

13 ‘‘(1) ADVERSE COVERAGE DETERMINATION.—

14 The term ‘adverse coverage determination’ means a

15 coverage determination under the plan which results

16 in a denial of coverage or reimbursement.

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

18 ‘coverage determination’ means with respect to items

19 and services for which coverage may be provided

20 under a health plan, a determination of whether or

21 not such items and services are covered or reimburs22 able under the coverage and terms of the contract.

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

24 participant or beneficiary.
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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 consist14 ing 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.
48

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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),’’.
49

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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
50

•S 326 IS

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 proceed5 ing.

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 individ12 ual 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 individ22 ual has filed a statement of disagreement under subsection

23 (b)(3), the entity involved, in any subsequent disclosure

24 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 en20 tity.

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 individ8 ual or dependent disclose, or authorize the col9 lection or disclosure of, predictive genetic infor10 mation for purposes of diagnosis, treatment, or

11 payment relating to the provision of health care

12 items and services to such individual or depend13 ent.

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 individ22 ual or dependent disclose, or authorize the col23 lection or disclosure of, predictive genetic infor24 mation for purposes of diagnosis, treatment, or

25 payment relating to the provision of health care
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1 items and services to such individual or depend2 ent.

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 concern19 ing such an enrollee or a family member of the enrollee

20 (including information about a request for or receipt of

21 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 individ12 ual market after 1 year after the date of enactment

13 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 relat24 ed activities authorized by the Social Security Act and the

25 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 clini4 cal 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 relat5 ed to the effectiveness, appropriateness, and cost-ef6 fectiveness of clinical preventive services for the pur7 pose of developing recommendations, and updating

8 previous recommendations, regarding their useful9 ness in daily clinical practice. In carrying out its re10 sponsibilities 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 provid5 ing 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 Commit21 tee on Health, Education, Labor, and Pensions

22 of the Senate and the Committee on Ways and

23 Means and the Committee on Commerce of the

24 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 individ14 ual 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 follow20 ing 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 carry6 ing 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 Reve23 nue 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.

Æ