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[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 326 Reported in Senate (RS)]

                                                       Calendar No. 160

106th CONGRESS

  1st Session

                                 S. 326

                          [Report No. 106-82]

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                             June 17, 1999

                       Reported with an amendment

                                                       Calendar No. 160
106th CONGRESS
  1st Session
                                 S. 326

                          [Report No. 106-82]

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

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            January 28, 1999

    Mr. Jeffords (for himself, Mr. Frist, Mr. DeWine, Mr. Enzi, Mr. 
 Hutchinson, Ms. Collins, Mr. Brownback, Mr. Hagel, Mr. Sessions, Mr. 
  Burns, and Mr. Gregg) introduced the following bill; which was read 
 twice and referred to the Committee on Health, Education, Labor, and 
                                Pensions

                             June 17, 1999

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

_______________________________________________________________________

                                 A BILL

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

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

<DELETED>SECTION 1. SHORT TITLE; TABLE OF CONTENTS.</DELETED>

<DELETED>    (a) Short Title.--This Act may be cited as the ``Patients' 
Bill of Rights Act''.</DELETED>
<DELETED>    (b) Table Of Contents.--The table of contents for this Act 
is as follows:</DELETED>

<DELETED>Sec. 1. Short title; table of contents.
               <DELETED>TITLE I--PATIENTS' BILL OF RIGHTS

             <DELETED>Subtitle A--Right to Advice and Care

<DELETED>``subpart c--patient right to medical advice and care
        <DELETED>``Sec. 721. Patient access to emergency medical care.
        <DELETED>``Sec. 722. Offering of choice of coverage options.
        <DELETED>``Sec. 723. Patient access to obstetric and 
                            gynecological care.
        <DELETED>``Sec. 724. Patient access to pediatric care.
        <DELETED>``Sec. 725. Continuity of care.
        <DELETED>``Sec. 726. Protection of patient-provider 
                            communications.
        <DELETED>``Sec. 727. Generally applicable provision.''
<DELETED>Sec. 102. Effective date and related rules.
  <DELETED>Subtitle B--Right to Information About Plans and Providers

<DELETED>Sec. 111. Information about plans.
<DELETED>Sec. 112. Information about providers.
      <DELETED>Subtitle C--Right to Hold Health Plans Accountable

<DELETED>Sec. 121. Amendment to Employee Retirement Income Security Act 
                            of 1974.
 <DELETED>TITLE II--INDIVIDUAL RIGHTS WITH RESPECT TO PERSONAL MEDICAL 
                              INFORMATION

<DELETED>Sec. 201. Short title.
             <DELETED>Subtitle A--Access to Medical Records

<DELETED>Sec. 211. Inspection and copying of protected health 
                            information.
<DELETED>Sec. 212. Amendment of protected health information.
<DELETED>Sec. 213. Notice of confidentiality practices.
            <DELETED>Subtitle B--Establishment of Safeguards

<DELETED>Sec. 221. Establishment of safeguards.
             <DELETED>Subtitle C--Enforcement; Definitions

<DELETED>Sec. 231. Civil penalty.
<DELETED>Sec. 232. Definitions.
<DELETED>Sec. 233. Effective date.
          <DELETED>TITLE III--GENETIC INFORMATION AND SERVICES

<DELETED>Sec. 301. Short title.
<DELETED>Sec. 302. Amendments to Employee Retirement Income Security 
                            Act of 1974.
<DELETED>Sec. 303. Amendments to the Public Health Service Act.
           <DELETED>TITLE IV--HEALTHCARE RESEARCH AND QUALITY

<DELETED>Sec. 401. Short title.
<DELETED>Sec. 402. Amendment to the Public Health Service Act.
    <DELETED>``TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

          <DELETED>``Part A--Establishment and General Duties

        <DELETED>``Sec. 901. Mission and duties.
        <DELETED>``Sec. 902. General authorities.
           <DELETED>``Part B--Healthcare Improvement Research

        <DELETED>``Sec. 911. Healthcare outcome improvement research.
        <DELETED>``Sec. 912. Private-public partnerships to improve 
                            organization and delivery.
        <DELETED>``Sec. 913. Information on quality and cost of care.
        <DELETED>``Sec. 914. Information systems for healthcare 
                            improvement.
        <DELETED>``Sec. 915. Research supporting primary care and 
                            access in underserved areas.
        <DELETED>``Sec. 916. Clinical practice and technology 
                            innovation.
        <DELETED>``Sec. 917. Coordination of Federal Government quality 
                            improvement efforts.
                 <DELETED>``Part C--General Provisions

        <DELETED>``Sec. 921. Advisory Council for Healthcare Research 
                            and Quality.
        <DELETED>``Sec. 922. Peer review with respect to grants and 
                            contracts.
        <DELETED>``Sec. 923. Certain provisions with respect to 
                            development, collection, and dissemination 
                            of data.
        <DELETED>``Sec. 924. Dissemination of information.
        <DELETED>``Sec. 925. Additional provisions with respect to 
                            grants and contracts.
        <DELETED>``Sec. 926. Certain administrative authorities.
        <DELETED>``Sec. 927. Funding.
        <DELETED>``Sec. 928. Definitions.''
<DELETED>Sec. 403. References.
<DELETED>Sec. 404. Study.
               <DELETED>TITLE V--MISCELLANEOUS PROVISIONS

<DELETED>Sec. 501. Sense of the Committee.

          <DELETED>TITLE I--PATIENTS' BILL OF RIGHTS</DELETED>

        <DELETED>Subtitle A--Right to Advice and Care</DELETED>

<DELETED>SEC. 101. PATIENT RIGHT TO MEDICAL ADVICE AND CARE.</DELETED>

<DELETED>    (a) In General.--Part 7 of subtitle B of title I of the 
Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 et 
seq.) is amended--</DELETED>
        <DELETED>    (1) by redesignating subpart C as subpart D; 
        and</DELETED>
        <DELETED>    (2) by inserting after subpart B the 
        following:</DELETED>

       <DELETED>``Subpart C--Patient Right to Medical Advice and 
                             Care</DELETED>

<DELETED>``SEC. 721. PATIENT ACCESS TO EMERGENCY MEDICAL 
              CARE.</DELETED>

<DELETED>    ``(a) In General.--To the extent that the group health 
plan (other than a fully insured group health plan) provides coverage 
for benefits consisting of emergency medical care (as defined in 
subsection (c)), except for items or services specifically excluded--
</DELETED>
        <DELETED>    ``(1) the plan shall provide coverage for 
        benefits, without requiring preauthorization, for appropriate 
        emergency medical screening examinations (within the capability 
        of the emergency facility, including ancillary services 
        routinely available to the emergency facility) to the extent 
        that a prudent layperson, who possesses an average knowledge of 
        health and medicine, would determine such examinations to be 
        necessary to determine whether emergency medical care (as so 
        defined) is necessary, and</DELETED>
        <DELETED>    ``(2) the plan shall provide coverage for benefits 
        for additional emergency medical care to stabilize an emergency 
        medical condition following an emergency medical screening 
        examination (if determined necessary under paragraph (1)), 
        pursuant to the definition of stabilize under section 
        1867(e)(3) of the Social Security Act (42 U.S.C. 
        1395dd(e)(3)).</DELETED>
<DELETED>    ``(b) Uniform Cost-Sharing Required.--Nothing in this 
section shall be construed as preventing a group health plan (other 
than a fully insured group health plan) from imposing any form of cost-
sharing applicable to any participant or beneficiary (including 
coinsurance, copayments, deductibles, and any other charges) in 
relation to coverage for benefits described in subsection (a), if such 
form of cost-sharing is uniformly applied under such plan, with respect 
to similarly situated participants and beneficiaries, to all benefits 
consisting of emergency medical care (as defined in subsection (c)) 
provided to such similarly situated participants and beneficiaries 
under the plan.</DELETED>
<DELETED>    ``(c) Definition of Emergency Medical Care.--In this 
section:</DELETED>
        <DELETED>    ``(1) In general.--The term ``emergency medical 
        care'' means, with respect to a participant or beneficiary 
        under a group health plan (other than a fully insured group 
        health plan), covered inpatient and outpatient services that--
        </DELETED>
                <DELETED>    ``(A) are furnished by any provider, 
                including a nonparticipating provider, that is 
                qualified to furnish such services; and</DELETED>
                <DELETED>    ``(B) are needed to evaluate or stabilize 
                (as such term is defined in section 1867(e)(3) of the 
                Social Security Act (42 U.S.C. 1395dd)) an emergency 
                medical condition (as defined in paragraph 
                (2)).</DELETED>
        <DELETED>    ``(2) Emergency medical condition.--The term 
        ``emergency medical condition'' means a medical condition 
        manifesting itself by acute symptoms of sufficient severity 
        (including severe pain) such that a prudent layperson, who 
        possesses an average knowledge of health and medicine, could 
        reasonably expect the absence of immediate medical attention to 
        result in--</DELETED>
                <DELETED>    ``(A) placing the health of the 
                participant or beneficiary (or, with respect to a 
                pregnant woman, the health of the woman or her unborn 
                child) in serious jeopardy,</DELETED>
                <DELETED>    ``(B) serious impairment to bodily 
                functions, or</DELETED>
                <DELETED>    ``(C) serious dysfunction of any bodily 
                organ or part.</DELETED>

<DELETED>``SEC. 722. OFFERING OF CHOICE OF COVERAGE OPTIONS.</DELETED>

<DELETED>    ``(a) Requirement.--</DELETED>
        <DELETED>    ``(1) Offering of point-of-service coverage 
        option.--Except as provided in paragraph (2), if a group health 
        plan (other than a fully insured group health plan) provides 
        coverage for benefits only through a defined set of 
        participating health care professionals, the plan shall offer 
        the participant the option to purchase point-of-service 
        coverage (as defined in subsection (b)) for all such benefits 
        for which coverage is otherwise so limited. Such option shall 
        be made available to the participant at the time of enrollment 
        under the plan and at such other times as the plan offers the 
        participant a choice of coverage options.</DELETED>
        <DELETED>    ``(2) Exception in the case of multiple issuer or 
        coverage options.--Paragraph (1) shall not apply with respect 
        to a participant in a group health plan (other than a fully 
        insured group health plan) if the plan offers the participant--
        </DELETED>
                <DELETED>    ``(A) a choice of health insurance 
                coverage through more than one health insurance issuer; 
                or</DELETED>
                <DELETED>    ``(B) two or more coverage options that 
                differ significantly with respect to the use of 
                participating health care professionals or the networks 
                of such professionals that are used.</DELETED>
<DELETED>    ``(b) Point-of-Service Coverage Defined.--In this section, 
the term `point-of-service coverage' means, with respect to benefits 
covered under a group health plan (other than a fully insured group 
health plan), coverage of such benefits when provided by a 
nonparticipating health care professional.</DELETED>
<DELETED>    ``(c) Small Employer Exemption.--</DELETED>
        <DELETED>    ``(1) In general.--This section shall not apply to 
        any group health plan (other than a fully insured group health 
        plan) of a small employer.</DELETED>
        <DELETED>    ``(2) Small employer.--For purposes of paragraph 
        (1), the term `small employer' means, in connection with a 
        group health plan (other than a fully insured group health 
        plan) with respect to a calendar year and a plan year, an 
        employer who employed an average of at least 2 but not more 
        than 50 employees on business days during the preceding 
        calendar year and who employs at least 2 employees on the first 
        day of the plan year. For purposes of this paragraph, the 
provisions of subparagraph (C) of section 712(c)(1) shall apply in 
determining employer size.</DELETED>
<DELETED>    ``(d) Rule of Construction.--Nothing in this section shall 
be construed--</DELETED>
        <DELETED>    ``(1) as requiring coverage for benefits for a 
        particular type of health care professional;</DELETED>
        <DELETED>    ``(2) as requiring an employer to pay any costs as 
        a result of this section or to make equal contributions with 
        respect to different health coverage options;</DELETED>
        <DELETED>    ``(3) as preventing a group health plan (other 
        than a fully insured group health plan) from imposing higher 
        premiums or cost-sharing on a participant for the exercise of a 
        point-of-service coverage option; or</DELETED>
        <DELETED>    ``(4) to require that a group health plan (other 
        than a fully insured group health plan) include coverage of 
        health care professionals that the plan excludes because of 
        fraud, quality of care, or other similar reasons with respect 
        to such professionals.</DELETED>

<DELETED>``SEC. 723. PATIENT ACCESS TO OBSTETRIC AND GYNECOLOGICAL 
              CARE.</DELETED>

<DELETED>    ``(a) In General.--In any case in which a group health 
plan (other than a fully insured group health plan)--</DELETED>
        <DELETED>    ``(1) provides coverage for benefits consisting 
        of--</DELETED>
                <DELETED>    ``(A) gynecological care (such as 
                preventive women's health examinations); or</DELETED>
                <DELETED>    ``(B) obstetric care (such as pregnancy-
                related services);</DELETED>
        <DELETED>provided by a participating physician who specializes 
        in such care; and</DELETED>
        <DELETED>    ``(2) requires or provides for designation by a 
        participant or beneficiary of a participating primary care 
        provider;</DELETED>
<DELETED>if the primary care provider designated by such a participant 
or beneficiary is not such a physician as described in paragraph (1), 
then the plan shall meet the requirements of subsection (b).</DELETED>
<DELETED>    ``(b) Requirements.--A group health plan (other than a 
fully insured group health plan) meets the requirements of this 
subsection, in connection with the coverage of benefits described in 
subsection (a) consisting of care described in subparagraph (A) or (B) 
of subsection (a)(1), if the plan--</DELETED>
        <DELETED>    ``(1) does not require authorization or a referral 
        by the primary care provider in order to obtain coverage for 
        such benefits, and</DELETED>
        <DELETED>    ``(2) treats the ordering of other routine care 
        related to the care described in subparagraph (A) or (B) of 
        subsection (a)(1), by the participating physician providing the 
        care described in either such subparagraph, as the 
        authorization of the primary care provider with respect to such 
        care.</DELETED>
<DELETED>    ``(c) Rule of Construction.--Nothing in subsection (b)(2) 
shall waive any requirements of coverage relating to medical necessity 
or appropriateness with respect to coverage of gynecological or 
obstetric care so ordered. Nothing in subsection (b) shall be construed 
to preclude the health plan from requiring that the obstetrician or 
gynecologist notify the primary care provider or the plan of treatment 
decisions.</DELETED>

<DELETED>``SEC. 724. PATIENT ACCESS TO PEDIATRIC CARE.</DELETED>

<DELETED>    ``(a) In General.--In any case in which a group health 
plan (other than a fully insured group health plan)--</DELETED>
        <DELETED>    ``(1) provides coverage for benefits consisting of 
        pediatric care by a participating pediatrician; and</DELETED>
        <DELETED>    ``(2) requires or provides for designation by a 
        participant or beneficiary of a participating primary care 
        provider;</DELETED>
<DELETED>if the primary care provider designated by such a participant 
or beneficiary is not a physician as described in paragraph (1), then 
the plan shall meet the requirements of subsection (b).</DELETED>
<DELETED>    ``(b) Requirements.--A group health plan (other than a 
fully insured group health plan) meets the requirements of this 
subsection, in connection with the coverage of benefits described in 
subsection (a) consisting of care described in subsection (a)(1), if 
the plan--</DELETED>
        <DELETED>    ``(1) does not require authorization or a referral 
        by the primary care provider in order to obtain coverage for 
        such benefits, and</DELETED>
        <DELETED>    ``(2) treats the ordering of other routine care of 
        the same type, by the participating physician providing the 
        care described in subsection (a)(1), as the authorization of 
        the primary care provider with respect to such care.</DELETED>
<DELETED>    ``(c) Construction.--Nothing in subsection (b)(2) shall 
waive any requirements of coverage relating to medical necessity or 
appropriateness with respect to coverage of pediatric care so 
ordered.</DELETED>

<DELETED>``SEC. 725. CONTINUITY OF CARE.</DELETED>

<DELETED>    ``(a) In General.--</DELETED>
        <DELETED>    ``(1) Termination of provider.--If a contract 
        between a group health plan (other than a fully insured group 
        health plan) and a health care provider is terminated (as 
        defined in paragraph (2)), or benefits or coverage provided by 
        a health care provider are terminated because of a change in 
        the terms of provider participation in such group health plan, 
        and an individual who is a participant or beneficiary in the 
        plan is undergoing a course of treatment from the provider at 
        the time of such termination, the plan shall--</DELETED>
                <DELETED>    ``(A) notify the individual on a timely 
                basis of such termination;</DELETED>
                <DELETED>    ``(B) provide the individual with an 
                opportunity to notify the plan of a need for 
                transitional care; and</DELETED>
                <DELETED>    ``(C) in the case of termination described 
                in paragraph (2), (3), or (4) of subsection (b), and 
                subject to subsection (c), permit the individual to 
                continue or be covered with respect to the course of 
                treatment with the provider's consent during a 
                transitional period (as provided under subsection 
                (b)).</DELETED>
        <DELETED>    ``(2) Terminated.--In this section, the term 
        `terminated' includes, with respect to a contract, the 
        expiration or nonrenewal of the contract by the group health 
        plan, but does not include a termination of the contract by the 
        plan for failure to meet applicable quality standards or for 
        fraud.</DELETED>
        <DELETED>    ``(3) Contracts.--For purposes of this section, 
        the term `contract between a group health plan (other than a 
        fully insured group health plan) and a health care provider' 
        shall include a contract between such a plan and an organized 
        network of providers.</DELETED>
<DELETED>    ``(b) Transitional Period.--</DELETED>
        <DELETED>    ``(1) General rule.--Except as provided in 
        paragraph (3), the transitional period under this subsection 
        shall extend for up to 90 days from the date of the notice 
        described in subsection (a)(1)(A) of the provider's 
        termination.</DELETED>
        <DELETED>    ``(2) Institutional care.--Subject to paragraph 
        (1), the transitional period under this subsection for 
        institutional or inpatient care from a provider shall extend 
        until the discharge or termination of the period of 
        institutionalization and also shall include institutional care 
        provided within a reasonable time of the date of termination of 
        the provider status if the care was scheduled before the date 
        of the announcement of the termination of the provider status 
        under subsection (a)(1)(A) or if the individual on such date 
        was on an established waiting list or otherwise scheduled to 
        have such care.</DELETED>
        <DELETED>    ``(3) Pregnancy.--Notwithstanding paragraph (1), 
        if--</DELETED>
                <DELETED>    ``(A) a participant or beneficiary has 
                entered the second trimester of pregnancy at the time 
                of a provider's termination of participation; 
                and</DELETED>
                <DELETED>    ``(B) the provider was treating the 
                pregnancy before the date of the termination;</DELETED>
        <DELETED>the transitional period under this subsection with 
        respect to provider's treatment of the pregnancy shall extend 
        through the provision of post-partum care directly related to 
        the delivery.</DELETED>
        <DELETED>    ``(4) Terminal illness.--Subject to paragraph (1), 
        if--</DELETED>
                <DELETED>    ``(A) a participant or beneficiary was 
                determined to be terminally ill (as determined under 
                section 1861(dd)(3)(A) of the Social Security Act) 
                prior to a provider's termination of participation; 
                and</DELETED>
                <DELETED>    ``(B) the provider was treating the 
                terminal illness before the date of 
                termination;</DELETED>
        <DELETED>the transitional period under this subsection shall be 
        for care directly related to the treatment of the terminal 
        illness.</DELETED>
<DELETED>    ``(c) Permissible Terms and Conditions.--A group health 
plan (other than a fully insured group health plan) may condition 
coverage of continued treatment by a provider under subsection 
(a)(1)(B) upon the provider agreeing to the following terms and 
conditions:</DELETED>
        <DELETED>    ``(1) The provider agrees to accept reimbursement 
        from the plan and individual involved (with respect to cost-
        sharing) at the rates applicable prior to the start of the 
        transitional period as payment in full (or, in the case 
        described in subsection (b)(2), at the rates applicable under 
        the replacement plan after the date of the termination of the 
        contract with the group health plan) and not to impose cost-
        sharing with respect to the individual in an amount that would 
        exceed the cost-sharing that could have been imposed if the 
        contract referred to in subsection (a)(1) had not been 
        terminated.</DELETED>
        <DELETED>    ``(2) The provider agrees to adhere to the quality 
        assurance standards of the plan responsible for payment under 
        paragraph (1) and to provide to such plan necessary medical 
        information related to the care provided.</DELETED>
        <DELETED>    ``(3) The provider agrees otherwise to adhere to 
        such plan's policies and procedures, including procedures 
        regarding referrals and obtaining prior authorization and 
        providing services pursuant to a treatment plan (if any) 
        approved by the plan.</DELETED>
<DELETED>    ``(d) Rule of Construction.--Nothing in this section shall 
be construed to require the coverage of benefits which would not have 
been covered if the provider involved remained a participating 
provider.</DELETED>
<DELETED>    ``(e) Definition.--In this section, the term `health care 
provider' or `provider' means--</DELETED>
        <DELETED>    ``(1) any individual who is engaged in the 
        delivery of health care services in a State and who is required 
        by State law or regulation to be licensed or certified by the 
        State to engage in the delivery of such services in the State; 
        and</DELETED>
        <DELETED>    ``(2) any entity that is engaged in the delivery 
        of health care services in a State and that, if it is required 
        by State law or regulation to be licensed or certified by the 
        State to engage in the delivery of such services in the State, 
        is so licensed.</DELETED>

<DELETED>``SEC. 726. PROTECTION OF PATIENT-PROVIDER 
              COMMUNICATIONS.</DELETED>

<DELETED>    ``(a) In General.--Subject to subsection (b), a group 
health plan (other than a fully insured group health plan and in 
relation to a participant or beneficiary) shall not prohibit or 
otherwise restrict a health care professional from advising such a 
participant or beneficiary who is a patient of the professional about 
the health status of the participant or beneficiary or medical care or 
treatment for the condition or disease of the participant or 
beneficiary, regardless of whether coverage for such care or treatment 
are provided under the contract, if the professional is acting within 
the lawful scope of practice.</DELETED>
<DELETED>    ``(b) Rule of Construction.--Nothing in this section shall 
be construed as requiring a group health plan (other than a fully 
insured group health plan) to provide specific benefits under the terms 
of such plan.</DELETED>

<DELETED>``SEC. 727. GENERALLY APPLICABLE PROVISION.</DELETED>

<DELETED>    ``In the case of a group health plan that provides 
benefits under 2 or more coverage options, the requirements of sections 
721, 723, 724, 725 and 726 shall apply separately with respect to each 
coverage option.''.</DELETED>
<DELETED>    (b) Definition.--Section 733(a) of the Employee Retirement 
Income Security Act of 1974 (42 U.S.C. 1186(a)) is amended by adding at 
the end the following:</DELETED>
        <DELETED>    ``(3) Fully insured group health plan.--The term 
        `fully insured group health plan' means a group health plan 
        where benefits are provided pursuant to the terms of an 
        arrangement between a group health plan and a health insurance 
        issuer and are guaranteed by the health insurance issuer under 
        a contract or policy of insurance.''.</DELETED>
<DELETED>    (c) Conforming Amendment.--The table of contents in 
section 1 of such Act is amended--</DELETED>
        <DELETED>    (1) in the item relating to subpart C, by striking 
        ``Subpart C'' and inserting ``Subpart D''; and</DELETED>
        <DELETED>    (2) by adding at the end of the items relating to 
        subpart B of part 7 of subtitle B of title I of such Act the 
        following new items:</DELETED>

         ``subpart c--patient right to medical advice and care
<DELETED>``Sec. 721. Patient access to emergency medical care.
<DELETED>``Sec. 722. Offering of choice of coverage options.
<DELETED>``Sec. 723. Patient access to obstetric and gynecological 
                            care.
<DELETED>``Sec. 724. Patient access to pediatric care.
<DELETED>``Sec. 725. Continuity of care.
<DELETED>``Sec. 726. Protection of patient-provider communications.
<DELETED>``Sec. 727. Generally applicable provisions.''.

<DELETED>SEC. 102. EFFECTIVE DATE AND RELATED RULES.</DELETED>

<DELETED>    (a) In General.--The amendments made by this subtitle 
shall apply with respect to plan years beginning on or after January 1 
of the second calendar year following the date of the enactment of this 
Act. The Secretary shall issue all regulations necessary to carry out 
the amendments made by this section before the effective date 
thereof.</DELETED>
<DELETED>    (b) Limitation on Enforcement Actions.--No enforcement 
action shall be taken, pursuant to the amendments made by this 
subtitle, against a group health plan with respect to a violation of a 
requirement imposed by such amendments before the date of issuance of 
regulations issued in connection with such requirement, if the plan has 
sought to comply in good faith with such requirement.</DELETED>

       <DELETED>Subtitle B--Right to Information About Plans and 
                          Providers</DELETED>

<DELETED>SEC. 111. INFORMATION ABOUT PLANS.</DELETED>

<DELETED>    (a) In General.--Subpart B of part 7 of subtitle B of 
title I of the Employee Retirement Income Security Act of 1974, as 
amended by the Omnibus Consolidated and Emergency Supplemental 
Appropriations Act, 1999 (Public Law 105-277), is amended by adding at 
the end the following:</DELETED>

<DELETED>``SEC. 714. HEALTH PLAN COMPARATIVE INFORMATION.</DELETED>

<DELETED>    ``(a) Requirement.--A group health plan, or health 
insurance issuer in connection with group health insurance coverage, 
shall, not later than 12 months after the date of enactment of this 
section, provide for the disclosure, in a clear and accurate form to 
each enrollee, or upon request to a potential enrollee eligible to 
receive benefits under the plan, or plan sponsor with which the plan or 
issuer has contracted, of the information described in subsection 
(b).</DELETED>
<DELETED>    ``(b) Required Information.--The informational materials 
to be distributed under this section shall include for each health 
benefit plan the following:</DELETED>
        <DELETED>    ``(1) A description of the covered items and 
        services under each such plan and any in- and out-of-network 
        features of each such plan.</DELETED>
        <DELETED>    ``(2) A description of any cost-sharing, including 
        premiums, deductibles, coinsurance, and copayment amounts, for 
        which the enrollee will be responsible, including any annual or 
        lifetime limits on benefits, for each such plan.</DELETED>
        <DELETED>    ``(3) A description of any optional supplemental 
        benefits offered by each such plan and the terms and conditions 
        (including premiums or cost-sharing) for such supplemental 
        coverage.</DELETED>
        <DELETED>    ``(4) A description of any restrictions on 
        payments for services furnished to an enrollee by a health care 
        professional that is not a participating professional and the 
        liability of the enrollee for additional payments for these 
        services.</DELETED>
        <DELETED>    ``(5) A description of the service area of each 
        such plan, including the provision of any out-of-area 
        coverage.</DELETED>
        <DELETED>    ``(6) A description of the extent to which 
        enrollees may select the primary care provider of their choice, 
        including providers both within the network and outside the 
        network of each such plan (if the plan permits out-of-network 
        services).</DELETED>
        <DELETED>    ``(7) A description of the procedures for advance 
        directives and organ donation decisions if the plan maintains 
        such procedures.</DELETED>
        <DELETED>    ``(8) A description of the requirements and 
        procedures to be used to obtain preauthorization for health 
services (including telephone numbers and mailing addresses), including 
referrals for specialty care.</DELETED>
        <DELETED>    ``(9) A summary of the rules and methods for 
        appealing coverage decisions and filing grievances (including 
        telephone numbers and mailing addresses), as well as other 
        available remedies.</DELETED>
        <DELETED>    ``(10) A summary of the rules for access to 
        emergency room care. Also, any available educational material 
        regarding proper use of emergency services.</DELETED>
        <DELETED>    ``(11) A description of whether or not coverage is 
        provided for experimental treatments, investigational 
        treatments, or clinical trials and the circumstances under 
        which access to such treatments or trials is made 
        available.</DELETED>
        <DELETED>    ``(12) A description of the specific preventative 
        services covered under the plan if such services are 
        covered.</DELETED>
        <DELETED>    ``(13) A statement regarding--</DELETED>
                <DELETED>    ``(A) the manner in which an enrollee may 
                access an obstetrician, gynecologist, or pediatrician 
                in accordance with section 723 or 724;</DELETED>
                <DELETED>    ``(B) the manner in which an enrollee 
                obtains continuity of care as provided for in section 
                725; and</DELETED>
                <DELETED>    ``(C) the manner in which an enrollee has 
                access to the medical records of the enrollee in 
                accordance with subtitle A of title II of the Patients' 
                Bill of Rights Act.</DELETED>
        <DELETED>    ``(14) A statement that the following information, 
        and instructions on obtaining such information (including 
        telephone numbers and, if available, Internet websites), shall 
        be made available upon request:</DELETED>
                <DELETED>    ``(A) The names, addresses, telephone 
                numbers, and State licensure status of the plan's 
                participating health care professionals and 
                participating health care facilities, and, if 
                available, the education, training, speciality 
                qualifications or certifications of such 
                professionals.</DELETED>
                <DELETED>    ``(B) A summary description of the methods 
                used for compensating participating health care 
                professionals, such as capitation, fee-for-service, 
                salary, or a combination thereof. The requirement of 
                this subparagraph shall not be construed as requiring 
                plans to provide information concerning proprietary 
                payment methodology.</DELETED>
                <DELETED>    ``(C) A summary description of the methods 
                used for compensating health care facilities, including 
                per diem, fee-for-service, capitation, bundled 
                payments, or a combination thereof. The requirement of 
                this subparagraph shall not be construed as requiring 
                plans to provide information concerning proprietary 
                payment methodology.</DELETED>
                <DELETED>    ``(D) A summary description of the 
                procedures used for utilization review.</DELETED>
                <DELETED>    ``(E) The list of the specific 
                prescription medications included in the formulary of 
                the plan, if the plan uses a defined formulary, and any 
                provision for obtaining off-formulary 
                medications.</DELETED>
                <DELETED>    ``(F) A description of the specific 
                exclusions from coverage under the plan.</DELETED>
                <DELETED>    ``(G) Any available information related to 
                the availability of translation or interpretation 
                services for non-English speakers and people with 
                communication disabilities, including the availability 
                of audio tapes or information in Braille.</DELETED>
                <DELETED>    ``(H) Any information that is made public 
                by accrediting organizations in the process of 
                accreditation if the plan is accredited, or any 
                additional quality indicators that the plan makes 
                available.</DELETED>
<DELETED>    ``(c) Manner of Distribution.--</DELETED>
        <DELETED>    ``(1) In general.--The information described in 
        this section shall be distributed in an accessible format that 
        is understandable to an average plan enrollee.</DELETED>
        <DELETED>    ``(2) Rule of construction.--For purposes of this 
        section, a group health plan, or health insurance issuer in 
        connection with group health insurance coverage, in reliance on 
        records maintained by the plan or issuer, shall be deemed to 
        have met the requirements of this section if the plan or issuer 
        provides the information requested under this section--
        </DELETED>
                <DELETED>    ``(A) in the case of the plan, to 
                participants and beneficiaries at the address contained 
                in such records with respect to such participants and 
                beneficiaries; or</DELETED>
                <DELETED>    ``(B) in the case of the issuer, to the 
                employer of a participant if the employer provides for 
                the coverage of such participant under the plan 
                involved or to participants and beneficiaries at the 
                address contained in such records with respect to such 
                participants and beneficiaries.</DELETED>
<DELETED>    ``(d) Rule of Construction.--Nothing in this section may 
be construed to prohibit a group health plan, or health insurance 
issuer in connection with group health insurance coverage, from 
distributing any other additional information determined by the plan or 
issuer to be important or necessary in assisting participants and 
beneficiaries enrollees or upon request potential participants in the 
selection of a health plan or from providing information under 
subsection (b)(13) as part of the required information.</DELETED>
<DELETED>    ``(e) Health Care Professional.--In this section, the term 
`health care professional' means a physician (as defined in section 
1861(r) of the Social Security Act) or other health care professional 
if coverage for the professional's services is provided under the 
health plan involved for the services of the professional. Such term 
includes a podiatrist, optometrist, chiropractor, psychologist, 
dentist, physician assistant, physical or occupational therapist and 
therapy assistant, speech-language pathologist, audiologist, registered 
or licensed practical nurse (including nurse practitioner, clinical 
nurse specialist, certified registered nurse anesthetist, and certified 
nurse-midwife), licensed certified social worker, registered 
respiratory therapist, and certified respiratory therapy 
technician.''.</DELETED>
<DELETED>    (b) Conforming Amendments.--</DELETED>
        <DELETED>    (1) Section 732(a) of the Employee Retirement 
        Income Security Act of 1974 (29 U.S.C. 1185(a)) is amended by 
        striking ``section 711, and inserting ``sections 711 and 
        714''.</DELETED>
        <DELETED>    (2) The table of contents in section 1 of the 
        Employee Retirement Income Security Act of 1974 (29 U.S.C. 
        1001) is amended by inserting after the item relating to 
        section 713, the following:</DELETED>

        <DELETED>``Sec. 714. Health plan comparative information.''.

<DELETED>SEC. 112. INFORMATION ABOUT PROVIDERS.</DELETED>

<DELETED>    (a) Study.--The Secretary of Health and Human Services 
shall enter into a contract with the Institute of Medicine for the 
conduct of a study, and the submission to the Secretary of a report, 
that includes--</DELETED>
        <DELETED>    (1) an analysis of information concerning health 
        care professionals that is currently available to patients, 
        consumers, States, and professional societies, nationally and 
        on a State-by-State basis, including patient preferences with 
        respect to information about such professionals and their 
        competencies;</DELETED>
        <DELETED>    (2) an evaluation of the legal and other barriers 
        to the sharing of information concerning health care 
        professionals; and</DELETED>
        <DELETED>    (3) recommendations for the disclosure of 
        information on health care professionals, including the 
        competencies and professional qualifications of such 
        practitioners, to better facilitate patient choice, quality 
        improvement, and market competition.</DELETED>
<DELETED>    (b) Report.--Not later than 18 months after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
forward to the appropriate committees of Congress a copy of the report 
and study conducted under subsection (a).</DELETED>

 <DELETED>Subtitle C--Right to Hold Health Plans Accountable</DELETED>

<DELETED>SEC. 121. AMENDMENT TO EMPLOYEE RETIREMENT INCOME SECURITY ACT 
              OF 1974.</DELETED>

<DELETED>    (a) In General.--Section 503 of the Employee Retirement 
Income Security Act of 1974 (29 U.S.C. 1133) is amended to read as 
follows:</DELETED>

<DELETED>``SEC. 503. CLAIMS PROCEDURE, COVERAGE DETERMINATION, 
              GRIEVANCES AND APPEALS.</DELETED>

<DELETED>    ``(a) Claims Procedure.--In accordance with regulations of 
the Secretary, every employee benefit plan shall--</DELETED>
        <DELETED>    ``(1) provide adequate notice in writing to any 
        participant or beneficiary whose claim for benefits under the 
        plan has been denied, setting forth the specific reasons for 
        such denial, written in a manner calculated to be understood by 
        the participant, and</DELETED>
        <DELETED>    ``(2) afford a reasonable opportunity to any 
        participant whose claim for benefits has been denied for a full 
        and fair review by the appropriate named fiduciary of the 
        decision denying the claim.</DELETED>
<DELETED>    ``(b) Coverage Determinations Under Group Health Plans.--
</DELETED>
        <DELETED>    ``(1) Procedures.--</DELETED>
                <DELETED>    ``(A) In general.--A group health plan or 
                health insurance issuer conducting utilization review 
                shall ensure that procedures are in place for--
                </DELETED>
                        <DELETED>    ``(i) making determinations 
                        regarding whether an enrollee is eligible to 
                        receive a payment or coverage for health 
                        services under the plan or coverage involved 
                        and any cost-sharing amount that the enrollee 
                        is required to pay with respect to such 
                        service;</DELETED>
                        <DELETED>    ``(ii) notifying covered enrollees 
                        (or the legal representative of such enrollees) 
                        and the treating health care professionals 
                        involved regarding determinations made under 
                        the plan or issuer and any additional payments 
                        that the enrollee may be required to make with 
                        respect to such service; and</DELETED>
                        <DELETED>    ``(iii) responding to requests, 
                        either written or oral, for coverage 
                        determinations or for internal appeals from an 
                        enrollee (or the legal representative of such 
                        enrollee) or the treating health care 
                        professional.</DELETED>
                <DELETED>    ``(B) Oral requests.--With respect to an 
                oral request described in subparagraph (A)(iii), a 
                group health plan or health insurance issuer may 
                require that the requesting individual provide written 
                evidence of such request.</DELETED>
        <DELETED>    ``(2) Timeline for making determinations.--
        </DELETED>
                <DELETED>    ``(A) Routine determination.--A group 
                health plan or a health insurance issuer shall maintain 
                procedures to ensure that prior authorization 
                determinations concerning the provision of non-
                emergency items or services are made within 30 days 
                from the date on which the request for a determination 
                is submitted, except that such period may be extended 
                where certain circumstances exist that are determined 
                by the Secretary to be beyond control of the plan or 
                issuer.</DELETED>
                <DELETED>    ``(B) Expedited determination.--</DELETED>
                        <DELETED>    ``(i) In general.--A prior 
                        authorization determination under this 
                        subsection shall be made within 72 hours after 
                        a request is received by the plan or issuer 
                        under clause (ii) or (iii).</DELETED>
                        <DELETED>    ``(ii) Request by enrollee.--A 
                        plan or issuer shall maintain procedures for 
                        expediting a prior authorization determination 
                        under this subsection upon the request of an 
                        enrollee if, based on such a request, the plan 
                        or issuer determines that the normal time for 
                        making such a determination could seriously 
                        jeopardize the life or health of the 
                        enrollee.</DELETED>
                        <DELETED>    ``(iii) Documentation by health 
                        care professional.--A plan or issuer shall 
                        maintain procedures for expediting a prior 
                        authorization determination under this 
                        subsection if the request involved indicates 
                        that the treating health care professional has 
                        documented, based on the medical exigencies, 
                        that a determination under the procedures 
                        described in subparagraph (A) could seriously 
                        jeopardize the life or health of the 
                        enrollee.</DELETED>
                <DELETED>    ``(C) Concurrent determinations.--A plan 
                or issuer shall maintain procedures to certify or deny 
                coverage of an extended stay or additional 
                services.</DELETED>
                <DELETED>    ``(D) Retrospective determination.--A plan 
                or issuer shall maintain procedures to ensure that, 
                with respect to the retrospective review of a 
                determination made under paragraph (1), the 
                determination shall be made within 30 working days of 
                the date on which the plan or issuer receives all 
                necessary information.</DELETED>
        <DELETED>    ``(3) Notice of determinations.--</DELETED>
                <DELETED>    ``(A) Routine determination.--With respect 
                to a coverage determination of a plan or issuer under 
                paragraph (2)(A), the plan or issuer shall issue notice 
                of such determination to the enrollee (or the legal 
                representative of the enrollee), and consistent with 
                the medical exigencies of the case, to the treating 
                health care professional involved not later than 2 
                working days after the date on which the determination 
                is made.</DELETED>
                <DELETED>    ``(B) Expedited determination.--With 
                respect to a coverage determination of a plan or issuer 
                under paragraph (2)(B), the plan or issuer shall issue 
                notice of such determination to the enrollee (or the 
                legal representative of the enrollee), and consistent 
                with the medical exigencies of the case, to the 
                treating health care professional involved within the 
                72 hour period described in paragraph (2)(B).</DELETED>
                <DELETED>    ``(C) Concurrent reviews.--With respect to 
                the determination under a plan or issuer under 
                paragraph (1) to certify or deny coverage of an 
                extended stay or additional services, the plan or 
                issuer shall issue notice of such determination to the 
                treating health care professional and to the enrollee 
                involved (or the legal representative of the enrollee) 
                within 1 working day of the date on which the initial 
                notice was issued.</DELETED>
                <DELETED>    ``(D) Retrospective reviews.--With respect 
                to the retrospective review under a plan or issuer of a 
                determination made under paragraph (1), a determination 
                shall be made within 30 working days of the date on 
                which the plan or issuer receives all necessary 
                information. The plan or issuer shall issue written 
                notice of an approval or disapproval of a determination 
                under this subparagraph to the enrollee (or the legal 
                representative of the enrollee) and health care 
                provider involved within 5 working days of the date on 
                which such determination is made.</DELETED>
                <DELETED>    ``(E) Requirements of notice of adverse 
                coverage determinations.--A written or electronic 
                notice of an adverse coverage determination under this 
                subsection, or of an expedited adverse coverage 
                determination under paragraph (2)(B), shall be provided 
                to the enrollee (or the legal representative of the 
                enrollee) and treating health care professional (if 
                any) involved and shall include--</DELETED>
                        <DELETED>    ``(i) the reasons for the 
                        determination (including the clinical or 
                        scientific-evidence based rationale used in 
                        making the determination) written in a manner 
                        to be understandable to the average 
                        enrollee;</DELETED>
                        <DELETED>    ``(ii) the procedures for 
                        obtaining additional information concerning the 
                        determination; and</DELETED>
                        <DELETED>    ``(iii) notification of the right 
                        to appeal the determination and instructions on 
                        how to initiate an appeal in accordance with 
                        subsection (d).</DELETED>
<DELETED>    ``(c) Grievances.--A group health plan or a health 
insurance issuer shall have written procedures for addressing 
grievances between the plan and enrollees. Determinations under such 
procedures shall be non-appealable.</DELETED>
<DELETED>    ``(d) Internal Appeal of Coverage Determinations.--
</DELETED>
        <DELETED>    ``(1) In general.--An enrollee (or the legal 
        representative of the enrollee) and the treating health care 
        professional with the consent of the enrollee (or the legal 
        representative of the enrollee), may appeal any adverse 
        coverage determination under subsection (b) under the 
        procedures described in this subsection.</DELETED>
        <DELETED>    ``(2) Records.--A group health plan and a health 
        insurance issuer shall maintain written records, for at least 6 
        years, with respect to any appeal under this subsection for 
        purposes of internal quality assurance and 
        improvement.</DELETED>
        <DELETED>    ``(3) Routine determinations.--A group health plan 
        or a health insurance issuer shall provide for the 
        consideration of an appeal of an adverse routine determination 
        under this subsection not later than 30 working days after the 
        date on which a request for such appeal is received.</DELETED>
        <DELETED>    ``(4) Expedited determination.--</DELETED>
                <DELETED>    ``(A) In general.--An expedited 
                determination with respect to an appeal under this 
                subsection shall be made in accordance with the medical 
                exigencies of the case, but in no case more than 72 
                hours after the request for such appeal is received by 
                the plan or issuer under subparagraph (B) or 
                (C).</DELETED>
                <DELETED>    ``(B) Request by enrollee.--A plan or 
                issuer shall maintain procedures for expediting a prior 
                authorization determination under this subsection upon 
                the request of an enrollee if, based on such a request, 
                the plan or issuer determines that the normal time for 
                making such a determination could seriously jeopardize 
                the life or health of the enrollee.</DELETED>
                <DELETED>    ``(C) Documentation by health care 
                professional.--A plan or issuer shall maintain 
                procedures for expediting a prior authorization 
                determination under this subsection if the request 
                involved indicates that the treating health care 
                professional has documented, based on the medical 
                exigencies that a determination under the procedures 
                described in paragraph (2) could seriously jeopardize 
                the life or health of the enrollee.</DELETED>
        <DELETED>    ``(5) Conduct of review.--A review of an adverse 
        coverage determination under this subsection shall be conducted 
        by an individual with appropriate expertise who was not 
        involved in the initial determination.</DELETED>
        <DELETED>    ``(6) Lack of medical necessity.--A review of an 
        appeal under this subsection relating to a determination to 
        deny coverage based on a lack of medical necessity or 
        appropriateness, or based on an experimental or investigational 
        treatment, shall be made only by a physician with appropriate 
        expertise in the field of medicine involved who was not 
        involved in the initial determination.</DELETED>
        <DELETED>    ``(7) Notice.--</DELETED>
                <DELETED>    ``(A) In general.--Written notice of a 
                determination made under an internal review process 
                shall be issued to the enrollee (or the legal 
                representative of the enrollee) and the treating health 
                care professional not later than 2 working days after 
                the completion of the review (or within the 72-hour 
                period referred to in paragraph (4) if 
                applicable).</DELETED>
                <DELETED>    ``(B) Adverse coverage determinations.--
                With respect to an adverse coverage determination made 
                under this subsection, the notice described in 
                subparagraph (A) shall include--</DELETED>
                        <DELETED>    ``(i) the reasons for the 
                        determination (including the clinical or 
                        scientific-evidence based rationale used in 
                        making the determination) written in a manner 
                        to be understandable to the average 
                        enrollee;</DELETED>
                        <DELETED>    ``(ii) the procedures for 
                        obtaining additional information concerning the 
                        determination; and</DELETED>
                        <DELETED>    ``(iii) notification of the right 
                        to an external review under subsection (e) and 
                        instructions on how to initiate such a 
                        review.</DELETED>
<DELETED>    ``(e) External Review.--</DELETED>
        <DELETED>    ``(1) In general.--A group health plan or a health 
        insurance issuer shall have written procedures to permit an 
        enrollee (or the legal representative of the enrollee) access 
        to an external review with respect to a coverage determination 
        concerning a particular item or service where--</DELETED>
                <DELETED>    ``(A) the particular item or service 
                involved, when medically appropriate and necessary, is 
                a covered benefit under the terms and conditions of the 
contract between the plan or issuer and the enrollee;</DELETED>
                <DELETED>    ``(B) the coverage determination involved 
                denied coverage for such item or service because the 
                provision of such item or service--</DELETED>
                        <DELETED>    ``(i) does not meet the plan's or 
                        issuer's requirements for medical 
                        appropriateness or necessity and the amount 
                        involved exceeds a significant financial 
                        threshold; or</DELETED>
                        <DELETED>    ``(ii) would constitute 
                        experimental or investigational treatment and 
                        there is a significant risk of placing the life 
                        or health of the enrollee in jeopardy; 
                        and</DELETED>
                <DELETED>    ``(C) the enrollee has completed the 
                internal appeals process with respect to such 
                determination.</DELETED>
        <DELETED>    ``(2) Initiation of the external review process.--
        </DELETED>
                <DELETED>    ``(A) Filing of request.--An enrollee (or 
                the legal representative of the enrollee) who desires 
                to have an external review conducted under this 
                subsection shall file a written request for such a 
                review with the plan or issuer involved not later than 
                30 working days after the receipt of a final denial of 
                a claim under subsection (d). Any such request shall 
                include the consent of the enrollee (or the legal 
                representative of the enrollee) for the release of 
                medical information and records to external reviewers 
                regarding the enrollee if such information is necessary 
                for the proper conduct of the external 
                review.</DELETED>
                <DELETED>    ``(B) Information and notice.--Not later 
                than 5 working days after the receipt of a request 
                under subparagraph (A), or earlier in accordance with 
                the medical exigencies of the case, the plan or issuer 
                involved shall select an external appeals entity under 
                paragraph (3)(A) that shall be responsible for 
                designating an external reviewer under paragraph 
                (3)(B).</DELETED>
                <DELETED>    ``(C) Provision of information.--The plan 
                or issuer involved shall forward all necessary 
                information (including medical records, any relevant 
                review criteria, the clinical rationale consistent with 
                the terms and conditions of the contract between the 
                plan or issuer and the enrollee for the coverage 
                denial, and evidence of the enrollee's coverage) to the 
                external reviewer selected under paragraph 
                (3)(B).</DELETED>
                <DELETED>    ``(D) Notification.--The plan or issuer 
                involved shall send a written notification to the 
                enrollee (or the legal representative of the enrollee) 
                and the plan administrator, indicating that an external 
                review has been initiated.</DELETED>
        <DELETED>    ``(3) Conduct of external review.--</DELETED>
                <DELETED>    ``(A) Designation of external appeals 
                entity by plan or issuer.--A plan or issuer that 
                receives a request for an external review under 
                paragraph (2)(A) shall designate one of the following 
                entities to serve as the external appeals 
                entity:</DELETED>
                        <DELETED>    ``(i) An external review entity 
                        licensed or credentialed by a State.</DELETED>
                        <DELETED>    ``(ii) A State agency established 
                        for the purpose of conducting independent 
                        external reviews.</DELETED>
                        <DELETED>    ``(iii) Any entity under contract 
                        with the Federal Government to provide external 
                        review services.</DELETED>
                        <DELETED>    ``(iv) Any entity accredited as an 
                        external review entity by an accrediting body 
                        recognized by the Secretary for such 
                        purpose.</DELETED>
                        <DELETED>    ``(v) Any fully accredited 
                        teaching hospital.</DELETED>
                        <DELETED>    ``(vi) Any other entity meeting 
                        criteria established by the Secretary for 
                        purposes of this subparagraph.</DELETED>
                <DELETED>    ``(B) Designation of external reviewer by 
                external appeals entity.--The external appeals entity 
                designated under subparagraph (A) shall, not later than 
                30 days after the date on which such entity is 
                designated under subparagraph (A), or earlier in 
                accordance with the medical exigencies of the case, 
                designate one or more individuals to serve as external 
                reviewers with respect to a request received under 
                paragraph (2)(A). Such reviewers shall be independent 
                medical experts who shall--</DELETED>
                        <DELETED>    ``(i) be appropriately 
                        credentialed or licensed in any State to 
                        deliver health care services;</DELETED>
                        <DELETED>    ``(ii) not have any material, 
                        professional, familial, or financial 
                        affiliation with the case under review, the 
                        enrollee involved, the treating health care 
                        professional, the institution where the 
                        treatment would take place, or the manufacturer 
of any drug, device, procedure, or other therapy proposed for the 
enrollee whose treatment is under review;</DELETED>
                        <DELETED>    ``(iii) be experts in the 
                        diagnosis or treatment under review and, when 
                        reasonably available, be of the same speciality 
                        of the physician prescribing the treatment in 
                        question;</DELETED>
                        <DELETED>    ``(iv) receive only reasonable and 
                        customary compensation from the group health 
                        plan or health insurance issuer in connection 
                        with the external review that is not contingent 
                        on the decision rendered by the reviewer; 
                        and</DELETED>
                        <DELETED>    ``(v) not be held liable for 
                        decisions regarding medical determinations (but 
                        may be held liable for actions that are 
                        arbitrary and capricious).</DELETED>
        <DELETED>    ``(4) Standard of review.--</DELETED>
                <DELETED>    ``(A) In general.--An external reviewer 
                shall--</DELETED>
                        <DELETED>    ``(i) make a determination based 
                        on the medical necessity, appropriateness, 
                        experimental or investigational nature of the 
                        coverage denial;</DELETED>
                        <DELETED>    ``(ii) take into consideration any 
                        evidence-based decision making or clinical 
                        practice guidelines used by the group health 
                        plan or health insurance issuer in conducting 
                        utilization review; and</DELETED>
                        <DELETED>    ``(iii) submit a report on the 
                        final determinations of the review involved 
                        to--</DELETED>
                                <DELETED>    ``(I) the plan or issuer 
                                involved;</DELETED>
                                <DELETED>    ``(II) the enrollee 
                                involved (or the legal representative 
                                of the enrollee); and</DELETED>
                                <DELETED>    ``(III) the health care 
                                professional involved.</DELETED>
                <DELETED>    ``(B) Notice.--The plan or issuer involved 
                shall ensure that the enrollee receives notice, within 
                30 days after the determination of the independent 
                medical expert, regarding the actions of the plan or 
                issuer with respect to the determination of such expert 
                under the external review.</DELETED>
        <DELETED>    ``(5) Timeframe for review.--</DELETED>
                <DELETED>    ``(A) In general.--An external reviewer 
                shall complete a review of an adverse coverage 
                determination in accordance with the medical exigencies 
                of the case.</DELETED>
                <DELETED>    ``(B) Limitation.--Notwithstanding 
                subparagraph (A), a review described in such 
                subparagraph shall be completed not later than 30 
                working days after the later of--</DELETED>
                        <DELETED>    ``(i) the date on which such 
                        reviewer is designated; or</DELETED>
                        <DELETED>    ``(ii) the date on which all 
                        information necessary to completing such review 
                        is received.</DELETED>
        <DELETED>    ``(6) Binding determination.--The determination of 
        an external reviewer under this subsection shall be binding 
        upon the plan or issuer if the provisions of this subsection or 
        the procedures implemented under such provisions were complied 
        with by the external reviewer.</DELETED>
        <DELETED>    ``(7) Study.--Not later than 2 years after the 
        date of enactment of this section, the General Accounting 
        Office shall conduct a study of a statistically appropriate 
        sample of completed external reviews. Such study shall include 
        an assessment of the process involved during an external review 
        and the basis of decisionmaking by the external reviewer. The 
        results of such study shall be submitted to the appropriate 
        committees of Congress.</DELETED>
        <DELETED>    ``(8) Effect on certain provisions.--Nothing in 
        this section shall be construed as affecting or modifying 
        section 514 of this Act with respect to a group health 
        plan.</DELETED>
<DELETED>    ``(f) Rule of Construction.--Nothing in this section shall 
be construed to prohibit a plan administrator or plan fiduciary or 
health plan medical director from requesting an external review by an 
external reviewer without first completing the internal review 
process.</DELETED>
<DELETED>    ``(g) Definitions.--In this section:</DELETED>
        <DELETED>    ``(1) Adverse coverage determination.--The term 
        `adverse coverage determination' means a coverage determination 
        under the plan which results in a denial of coverage or 
        reimbursement.</DELETED>
        <DELETED>    ``(2) Coverage determination.--The term `coverage 
        determination' means with respect to items and services for 
        which coverage may be provided under a health plan, a 
        determination of whether or not such items and services are 
        covered or reimbursable under the coverage and terms of the 
        contract.</DELETED>
        <DELETED>    ``(3) Enrollee.--The term enrollee means a 
        participant or beneficiary.</DELETED>
        <DELETED>    ``(4) Grievance.--The term `grievance' means any 
        enrollee complaint that does not involve a coverage 
        determination.</DELETED>
        <DELETED>    ``(5) Group health plan.--The term `group health 
        plan' shall have the meaning given such term in section 733(a). 
        In applying this paragraph, excepted benefits described in 
        section 733(c) shall not be treated as benefits consisting of 
        medical care.</DELETED>
        <DELETED>    ``(6) Health insurance coverage.--The term `health 
        insurance coverage' has the meaning given such term in section 
        733(b)(1). In applying this paragraph, excepted benefits 
        described in section 733(c) shall not be treated as benefits 
        consisting of medical care.</DELETED>
        <DELETED>    ``(7) Health insurer.--The term `health insurer' 
        means an insurance company, insurance service, or an insurance 
        organization that meets the requirements of section 733(b)(2) 
        and that offers health insurance coverage in connection with a 
        group health plan.</DELETED>
        <DELETED>    ``(8) Prior authorization determination.--The term 
        `prior authorization determination' means a coverage 
        determination prior to the provision of the items and services 
        as a condition of coverage of the items and services under the 
        coverage.</DELETED>
        <DELETED>    ``(9) Treating health care professional.--The term 
        `treating health care professional' with respect to a group 
        health plan, health insurance issuer or provider sponsored 
        organization means a practitioner who is acting within the 
        scope of their State licensure or certification for the 
        delivery of health care services and who is primarily 
        responsible for delivering those services to the 
        enrollee.</DELETED>
        <DELETED>    ``(10) Utilization review.--The term `utilization 
        review' with respect to a group health plan or health insurance 
        coverage means a set of formal techniques designed to monitor 
        the use of, or evaluate the clinical necessity, 
        appropriateness, efficacy, or efficiency of, health care 
        services, procedures, or settings. Techniques may include 
        ambulatory review, prospective review, second opinion, 
        certification, concurrent review, case management, discharge 
        planning or retrospective review.''</DELETED>
<DELETED>    (b) Enforcement.--Section 502(c)(1) of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 1132(c)(1)) is 
amended by inserting after ``or section 101(e)(1)'' the following: ``, 
or fails to comply with a coverage determination as required under 
section 503(e)(6),''.</DELETED>
<DELETED>    (c) Conforming Amendment.--The table of contents in 
section 1 of the Employee Retirement Income Security Act of 1974 is 
amended by striking the item relating to section 503 and inserting the 
following new item:</DELETED>

<DELETED>``Sec. 503. Claims procedures, coverage determination, 
                            grievances and appeals.''.
<DELETED>    (d) Effective Date.--The amendments made by this section 
shall apply with respect to plan years beginning on or after 1 year 
after the date of enactment of this Act. The Secretary shall issue all 
regulations necessary to carry out the amendments made by this section 
before the effective date thereof.</DELETED>

 <DELETED>TITLE II--INDIVIDUAL RIGHTS WITH RESPECT TO PERSONAL MEDICAL 
                         INFORMATION</DELETED>

<DELETED>SEC. 201. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Personal Medical 
Information Access Act''.</DELETED>

        <DELETED>Subtitle A--Access to Medical Records</DELETED>

<DELETED>SEC. 211. INSPECTION AND COPYING OF PROTECTED HEALTH 
              INFORMATION.</DELETED>

<DELETED>    (a) In General.--At the request of an individual and 
except as provided in subsection (b), a health care provider, health 
plan, employer, health or life insurer, school, or university shall 
permit an individual who is the subject of protected health information 
or the individual's designee, to inspect and copy protected health 
information concerning the individual, including records created under 
section 212 that such entity maintains. Such entity may set forth 
appropriate procedures to be followed for such inspection or copying 
and may require an individual to pay reasonable costs associated with 
such inspection or copying.</DELETED>
<DELETED>    (b) Exceptions.--Unless ordered by a court of competent 
jurisdiction, an entity described in subsection (a) is not required to 
permit the inspection or copying of protected health information if any 
of the following conditions are met:</DELETED>
        <DELETED>    (1) Endangerment to life or safety.--The entity 
        determines that the disclosure of the information could 
        reasonably be expected to endanger the life or physical safety 
        of an individual.</DELETED>
        <DELETED>    (2) Confidential source.--The information 
        identifies, or could reasonably lead to the identification of, 
        a person who provided information under a promise of 
        confidentiality concerning the individual who is the subject of 
        the information.</DELETED>
        <DELETED>    (3) Information compiled in anticipation of 
        litigation.--The information is compiled principally--
        </DELETED>
                <DELETED>    (A) in the reasonable anticipation of a 
                civil, criminal, or administrative action or 
                proceeding; or</DELETED>
                <DELETED>    (B) for use in such an action or 
                proceeding.</DELETED>
        <DELETED>    (4) Research purposes.--The information was 
        collected for a research project monitored by an institutional 
        review board, such project is not complete, and the researcher 
        involved reasonably believes that access to such information 
        would harm the conduct of the research or invalidate or 
        undermine the validity of the research.</DELETED>
<DELETED>    (c) Denial of a Request for Inspection or Copying.--If an 
entity described in subsection (a) denies a request for inspection or 
copying pursuant to subsection (b), the entity shall inform the 
individual in writing of--</DELETED>
        <DELETED>    (1) the reasons for the denial of the request for 
        inspection or copying;</DELETED>
        <DELETED>    (2) any procedures for further review of the 
        denial; and</DELETED>
        <DELETED>    (3) the individual's right to file with the entity 
        a concise statement setting forth the request for inspection or 
        copying.</DELETED>
<DELETED>    (d) Statement Regarding Request.--If an individual has 
filed a statement under subsection (c)(3), the entity in any subsequent 
disclosure of the portion of the information requested under subsection 
(a) shall include--</DELETED>
        <DELETED>    (1) a copy of the individual's statement; 
        and</DELETED>
        <DELETED>    (2) a concise statement of the reasons for denying 
        the request for inspection or copying.</DELETED>
<DELETED>    (e) Inspection and Copying of Segregable Portion.--An 
entity described in subsection (a) shall permit the inspection and 
copying under subsection (a) of any reasonably segregable portion of 
protected health information after deletion of any portion that is 
exempt under subsection (b).</DELETED>
<DELETED>    (f) Deadline.--An entity described in subsection (a) shall 
comply with or deny, in accordance with subsection (c), a request for 
inspection or copying of protected health information under this 
section not later than 45 days after the date on which the entity 
receives the request.</DELETED>
<DELETED>    (g) Rules Governing Agents.--An agent of an entity 
described in subsection (a) shall not be required to provide for the 
inspection and copying of protected health information, except where--
</DELETED>
        <DELETED>    (1) the protected health information is retained 
        by the agent; and</DELETED>
        <DELETED>    (2) the agent has received in writing a request 
        from the entity involved to fulfill the requirements of this 
        section;</DELETED>
<DELETED>at which time such information shall be provided to the 
requesting entity. Such requesting entity shall comply with subsection 
(f) with respect to any such information.</DELETED>
<DELETED>    (h) Rule of Construction.--This section shall not be 
construed to require an entity described in subsection (a) to conduct a 
formal, informal, or other hearing or proceeding concerning a request 
for inspection or copying of protected health information.</DELETED>

<DELETED>SEC. 212. AMENDMENT OF PROTECTED HEALTH INFORMATION.</DELETED>

<DELETED>    (a) Requirement.--</DELETED>
        <DELETED>    (1) In general.--Except as provided in subsection 
        (b) and subject to paragraph (2), a health care provider, 
        health plan, employer, health or life insurer, school, or 
        university that receives from an individual a request in 
        writing to amend protected health information shall--</DELETED>
                <DELETED>    (A) amend such information as 
                requested;</DELETED>
                <DELETED>    (B) inform the individual of the amendment 
                that has been made; and</DELETED>
                <DELETED>    (C) make reasonable efforts to inform any 
                person to whom the unamended portion of the information 
                was previously disclosed, of any nontechnical amendment 
                that has been made.</DELETED>
        <DELETED>    (2) Compliance.--An entity described in paragraph 
        (1) shall comply with the requirements of such paragraph within 
        45 days of the date on which the request involved is received 
        if the entity--</DELETED>
                <DELETED>    (A) created the protected health 
                information involved; and</DELETED>
                <DELETED>    (B) determines that such information is in 
                fact inaccurate.</DELETED>
<DELETED>    (b) Refusal To Amend.--If an entity described in 
subsection (a) refuses to make the amendment requested under such 
subsection, the entity shall inform the individual in writing of--
</DELETED>
        <DELETED>    (1) the reasons for the refusal to make the 
        amendment;</DELETED>
        <DELETED>    (2) any procedures for further review of the 
        refusal; and</DELETED>
        <DELETED>    (3) the individual's right to file with the entity 
        a concise statement setting forth the requested amendment and 
        the individual's reasons for disagreeing with the 
        refusal.</DELETED>
<DELETED>    (c) Statement of Disagreement.--If an individual has filed 
a statement of disagreement under subsection (b)(3), the entity 
involved, in any subsequent disclosure of the disputed portion of the 
information--</DELETED>
        <DELETED>    (1) shall include a copy of the individual's 
        statement; and</DELETED>
        <DELETED>    (2) may include a concise statement of the reasons 
        for not making the requested amendment.</DELETED>
<DELETED>    (d) Rules Governing Agents.--The agent of an entity 
described in subsection (a) shall not be required to make amendments to 
protected health information, except where--</DELETED>
        <DELETED>    (1) the protected health information is retained 
        by the agent; and</DELETED>
        <DELETED>    (2) the agent has been asked by such entity to 
        fulfill the requirements of this section.</DELETED>
<DELETED>If the agent is required to comply with this section as 
provided for in paragraph (2), such agent shall be subject to the 45-
day deadline described in subsection (a).</DELETED>
<DELETED>    (e) Repeated Requests for Amendments.--If an entity 
described in subsection (a) receives a request for an amendment of 
information as provided for in such subsection and a statement of 
disagreement has been filed pursuant to subsection (c), the entity 
shall inform the individual of such filing and shall not be required to 
carry out the procedures required under this section.</DELETED>
<DELETED>    (f) Rules of Construction.--This section shall not be 
construed to--</DELETED>
        <DELETED>    (1) require that an entity described in subsection 
        (a) conduct a formal, informal, or other hearing or proceeding 
        concerning a request for an amendment to protected health 
        information;</DELETED>
        <DELETED>    (2) require a provider to amend an individual's 
        protected health information as to the type, duration, or 
        quality of treatment the individual believes he or she should 
        have been provided; or</DELETED>
        <DELETED>    (3) permit any deletions or alterations of the 
        original information.</DELETED>

<DELETED>SEC. 213. NOTICE OF CONFIDENTIALITY PRACTICES.</DELETED>

<DELETED>    (a) Preparation of Written Notice.--A health care 
provider, health plan, health oversight agency, public health 
authority, employer, health or life insurer, health researcher, school 
or university shall post or provide, in writing and in a clear and 
conspicuous manner, notice of the entity's confidentiality practices, 
that shall include--</DELETED>
        <DELETED>    (1) a description of an individual's rights with 
        respect to protected health information;</DELETED>
        <DELETED>    (2) the procedures established by the entity for 
        the exercise of the individual's rights; and</DELETED>
        <DELETED>    (3) the right to obtain a copy of the notice of 
        the confidentiality practices required under this 
        subtitle.</DELETED>
<DELETED>    (b) Model Notice.--The Secretary, in consultation with the 
National Committee on Vital and Health Statistics and the National 
Association of Insurance Commissioners, and after notice and 
opportunity for public comment, shall develop and disseminate model 
notices of confidentiality practices. Use of the model notice shall 
serve as a defense against claims of receiving inappropriate 
notice.</DELETED>

       <DELETED>Subtitle B--Establishment of Safeguards</DELETED>

<DELETED>SEC. 221. ESTABLISHMENT OF SAFEGUARDS.</DELETED>

<DELETED>    A health care provider, health plan, health oversight 
agency, public health authority, employer, health or life insurer, 
health researcher, law enforcement official, school or university shall 
establish and maintain appropriate administrative, technical, and 
physical safeguards to protect the confidentiality, security, accuracy, 
and integrity of protected health information created, received, 
obtained, maintained, used, transmitted, or disposed of by such 
entity.</DELETED>

        <DELETED>Subtitle C--Enforcement; Definitions</DELETED>

<DELETED>SEC. 231. CIVIL PENALTY.</DELETED>

<DELETED>    (a) Violation.--A health care provider, health researcher, 
health plan, health oversight agency, public health agency, law 
enforcement agency, employer, health or life insurer, school, or 
university, or the agent of any such individual or entity, who the 
Secretary, in consultation with the Attorney General, determines has 
substantially and materially failed to comply with this Act shall, for 
a violation of this title, be subject, in addition to any other 
penalties that may be prescribed by law, to a civil penalty of not more 
than $500 for each such violation, but not to exceed $5,000 in the 
aggregate for multiple violations.</DELETED>
<DELETED>    (b) Procedures for Imposition of Penalties.--Section 1128A 
of the Social Security Act, other than subsections (a) and (b) and the 
second sentence of subsection (f) of that section, shall apply to the 
imposition of a civil, monetary, or exclusionary penalty under this 
section in the same manner as such provisions apply with respect to the 
imposition of a penalty under section 1128A of such Act.</DELETED>

<DELETED>SEC. 232. DEFINITIONS.</DELETED>

<DELETED>    In this title:</DELETED>
        <DELETED>    (1) Agent.--The term ``agent'' means a person who 
        represents and acts for another under the contract or relation 
        of agency, or whose function is to bring about, modify, affect, 
        accept performance of, or terminate contractual obligations 
        between the principal and a third person, including a 
        contractor.</DELETED>
        <DELETED>    (2) Disclose.--The term ``disclose'' means to 
        release, transfer, provide access to, or otherwise divulge 
        protected health information to any person other than the 
        individual who is the subject of such information. Such term 
        includes the initial disclosure and any subsequent 
        redisclosures of protected health information.</DELETED>
        <DELETED>    (3) Employer.--The term ``employer'' has the 
        meaning given such term under section 3(5) of the Employee 
        Retirement Income Security Act of 1974 (29 U.S.C. 1002(5)), 
        except that such term shall include only employers of 2 or more 
        employees.</DELETED>
        <DELETED>    (4) Health care provider.--The term ``health care 
        provider'' means a person who, with respect to a specific item 
        of protected health information, receives, creates, uses, 
        maintains, or discloses the information while acting in whole 
        or in part in the capacity of--</DELETED>
                <DELETED>    (A) a person who is licensed, certified, 
                registered, or otherwise authorized by Federal or State 
                law to provide an item or service that constitutes 
                health care in the ordinary course of business, or 
                practice of a profession;</DELETED>
                <DELETED>    (B) a Federal, State, or employer-
                sponsored program that directly provides items or 
                services that constitute health care to beneficiaries; 
                or</DELETED>
                <DELETED>    (C) an officer, employee, or agent of a 
                person described in subparagraph (A) or (B).</DELETED>
        <DELETED>    (5) Health or life insurer.--The term ``health or 
        life insurer'' means a health insurance issuer as defined in 
        section 2791 of the Public Health Service Act (42 U.S.C. 300gg-
        91) or a life insurance company as defined in section 816 of 
        the Internal Revenue Code of 1986.</DELETED>
        <DELETED>    (6) Health plan.--The term ``health plan'' means 
        any health insurance plan, including any hospital or medical 
        service plan, dental or other health service plan or health 
        maintenance organization plan, provider sponsored organization, 
        or other program providing or arranging for the provision of 
        health benefits, whether or not funded through the purchase of 
        insurance.</DELETED>
        <DELETED>    (7) Person.--The term ``person'' means a 
        government, governmental subdivision, agency or authority; 
        corporation; company; association; firm; partnership; society; 
        estate; trust; joint venture; individual; individual 
        representative; tribal government; and any other legal 
        entity.</DELETED>
        <DELETED>    (8) Protected health information.--The term 
        ``protected health information'' means any information 
        (including demographic information) whether or not recorded in 
        any form or medium--</DELETED>
                <DELETED>    (A) that relates to the past, present or 
                future--</DELETED>
                        <DELETED>    (i) physical or mental health or 
                        condition of an individual (including the 
                        condition or other attributes of individual 
                        cells or their components);</DELETED>
                        <DELETED>    (ii) provision of health care to 
                        an individual; or</DELETED>
                        <DELETED>    (iii) payment for the provision of 
                        health care to an individual;</DELETED>
                <DELETED>    (B) that is created by a health care 
                provider, health plan, health researcher, health 
                oversight agency, public health authority, employer, 
                law enforcement official, health or life insurer, 
                school or university; and</DELETED>
                <DELETED>    (C) that is not nonidentifiable health 
                information.</DELETED>
        <DELETED>    (9) School or university.--The term ``school or 
        university'' means an institution or place for instruction or 
        education, including an elementary school, secondary school, or 
        institution of higher learning, a college, or an assemblage of 
        colleges united under one corporate organization or 
        government.</DELETED>
        <DELETED>    (10) Secretary.--The term ``Secretary'' means the 
        Secretary of Health and Human Services.</DELETED>
        <DELETED>    (11) Writing.--The term ``writing'' means writing 
        in either a paper-based or computer-based form, including 
        electronic signatures.</DELETED>

<DELETED>SEC. 233. EFFECTIVE DATE.</DELETED>

<DELETED>    The provisions of this title shall become effective 
beginning on the date that is 1 year after the date of enactment of 
this Act. The Secretary shall issue regulations necessary to carry out 
this title before the effective date thereof.</DELETED>

     <DELETED>TITLE III--GENETIC INFORMATION AND SERVICES</DELETED>

<DELETED>SEC. 301. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Genetic Information 
Nondiscrimination in Health Insurance Act of 1999''.</DELETED>

<DELETED>SEC. 302. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME SECURITY 
              ACT OF 1974.</DELETED>

<DELETED>    (a) Prohibition of Health Discrimination on the Basis of 
Genetic Information or Genetic Services.--</DELETED>
        <DELETED>    (1) No enrollment restriction for genetic 
        services.--Section 702(a)(1)(F) of the Employee Retirement 
        Income Security Act of 1974 (29 U.S.C. 1182(a)(1)(F)) is 
        amended by inserting before the period the following: 
        ``(including information about a request for or receipt of 
        genetic services)''.</DELETED>
        <DELETED>    (2) No discrimination in group premiums based on 
        predictive genetic information.--Subpart B of part 7 of 
        subtitle B of title I of the Employee Retirement Income 
        Security Act of 1974 (29 U.S.C. 1185 et seq.) (as amended by 
        section 111) is further amended by adding at the end the 
        following:</DELETED>

<DELETED>``SEC. 714. PROHIBITING PREMIUM DISCRIMINATION AGAINST GROUPS 
              ON THE BASIS OF PREDICTIVE GENETIC INFORMATION.</DELETED>

<DELETED>    ``A group health plan, or a health insurance issuer 
offering group health insurance coverage in connection with a group 
health plan, shall not adjust premium or contribution amounts for a 
group on the basis of predictive genetic information concerning an 
individual in the group or a family member of the individual (including 
information about a request for or receipt of genetic 
services).''.</DELETED>
        <DELETED>    (3) Conforming amendment.--Section 702(b) of the 
        Employee Retirement Income Security Act of 1974 (29 U.S.C. 
1182(b)) is amended by adding at the end the following:</DELETED>
        <DELETED>    ``(3) Reference to related provision.--For a 
        provision prohibiting the adjustment of premium or contribution 
        amounts for a group under a group health plan on the basis of 
        predictive genetic information (including information about a 
        request for or receipt of genetic services), see section 
        714.''.</DELETED>
<DELETED>    (b) Limitation on Collection of Predictive Genetic 
Information.--Section 702 of the Employee Retirement Income Security 
Act of 1974 (29 U.S.C. 1182) is amended by adding at the end the 
following:</DELETED>
<DELETED>    ``(c) Collection of Predictive Genetic Information.--
</DELETED>
        <DELETED>    ``(1) Limitation on requesting or requiring 
        predictive genetic information.--Except as provided in 
        paragraph (2), a group health plan, or a health insurance 
        issuer offering health insurance coverage in connection with a 
        group health plan, shall not request or require predictive 
        genetic information concerning an individual or a family member 
        of the individual (including information about a request for or 
        receipt of genetic services).</DELETED>
        <DELETED>    ``(2) Information needed for diagnosis, treatment, 
        or payment.--</DELETED>
                <DELETED>    ``(A) In general.--Notwithstanding 
                paragraph (1), a group health plan or health insurance 
                issuer that provides health care items and services to 
                an individual or dependent may request (but may not 
                require) that such individual or dependent disclose, or 
                authorize the collection or disclosure of, predictive 
                genetic information for purposes of diagnosis, 
                treatment, or payment relating to the provision of 
                health care items and services to such individual or 
                dependent.</DELETED>
                <DELETED>    ``(B) Notice of confidentiality practices 
                and description of safeguards.--As a part of a request 
                under subparagraph (A), the group health plan or health 
                insurance issuer shall provide to the individual or 
                dependent a description of the procedures in place to 
                safeguard the confidentiality, as described in sections 
                213 and 221 of the Patients' Bill of Rights Act, of 
                such individually identifiable 
                information.''.</DELETED>
<DELETED>    (c) Definitions.--Section 733(d) of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 1191b(d)) is amended 
by adding at the end the following:</DELETED>
        <DELETED>    ``(5) Family member.--The term `family member' 
        means with respect to an individual--</DELETED>
                <DELETED>    ``(A) the spouse of the 
                individual;</DELETED>
                <DELETED>    ``(B) a dependent child of the individual, 
                including a child who is born to or placed for adoption 
                with the individual; and</DELETED>
                <DELETED>    ``(C) all other individuals related by 
                blood to the individual or the spouse or child 
                described in subparagraph (A) or (B).</DELETED>
        <DELETED>    ``(6) Genetic information.--The term `genetic 
        information' means information about genes, gene products, or 
        inherited characteristics that may derive from an individual or 
        a family member (including information about a request for or 
        receipt of genetic services).</DELETED>
        <DELETED>    ``(7) Genetic services.--The term `genetic 
        services' means health services provided to obtain, assess, or 
        interpret genetic information for diagnostic and therapeutic 
        purposes, and for genetic education and counseling.</DELETED>
        <DELETED>    ``(8) Predictive genetic information.--</DELETED>
                <DELETED>    ``(A) In general.--The term `predictive 
                genetic information' means--</DELETED>
                        <DELETED>    ``(i) information about an 
                        individual's genetic tests which are associated 
                        with a statistically significant increased risk 
                        of developing a disease or disorder;</DELETED>
                        <DELETED>    ``(ii) information about genetic 
                        tests of family members of the individual; 
                        or</DELETED>
                        <DELETED>    ``(iii) information about the 
                        occurrence of a disease or disorder in family 
                        members that predicts a statistically 
                        significant increased risk of a disease or 
                        disorder in the individual.</DELETED>
                <DELETED>    ``(B) Exceptions.--The term `predictive 
                genetic information' shall not include--</DELETED>
                        <DELETED>    ``(i) information about the sex or 
                        age of the individual;</DELETED>
                        <DELETED>    ``(ii) information derived from 
                        routine physical tests, such as the chemical, 
                        blood, or urine analyses of the individual, 
                        unless such analyses are genetic tests; 
                        and</DELETED>
                        <DELETED>    ``(iii) information about physical 
                        exams of the individual and other information 
                        relevant to determining the current health 
                        status of the individual so long as such 
                        information does not include information 
                        described in clauses (i), (ii), or (iii) of 
                        subparagraph (A).</DELETED>
        <DELETED>    ``(9) Genetic test.--The term `genetic test' means 
        the analysis of human DNA, RNA, chromosomes, proteins, and 
        certain metabolites, in order to detect disease-related 
        genotypes, mutations, phenotypes, or karyotypes.''.</DELETED>
<DELETED>    (d) Effective Date.--Except as provided in this section, 
this section and the amendments made by this section shall apply with 
respect to group health plans for plan years beginning 1 year after the 
date of the enactment of this Act.</DELETED>

<DELETED>SEC. 303. AMENDMENTS TO THE PUBLIC HEALTH SERVICE 
              ACT.</DELETED>

<DELETED>    (a) Amendments Relating to the Group Market.--</DELETED>
        <DELETED>    (1) Prohibition of health discrimination on the 
        basis of genetic information in the group market.--</DELETED>
                <DELETED>    (A) In general.--Subpart 2 of part A of 
                title XXVII of the Public Health Service Act, as 
                amended by the Omnibus Consolidated and Emergency 
                Supplemental Appropriations Act, 1999 (Public Law 105-
                277), is amended by adding at the end the following new 
                section:</DELETED>

<DELETED>``SEC. 2707. PROHIBITING PREMIUM DISCRIMINATION AGAINST GROUPS 
              ON THE BASIS OF PREDICTIVE GENETIC INFORMATION IN THE 
              GROUP MARKET.</DELETED>

<DELETED>    ``A group health plan, or a health insurance issuer 
offering group health insurance coverage in connection with a group 
health plan shall not adjust premium or contribution amounts for a 
group on the basis of predictive genetic information concerning an 
individual in the group or a family member of the individual (including 
information about a request for or receipt of genetic 
services).''.</DELETED>
                <DELETED>    (B) Conforming amendment.--Section 2702(b) 
                of the Public Health Service Act (42 U.S.C. 300gg-1(b)) 
                is amended by adding at the end the 
                following:</DELETED>
        <DELETED>    ``(3) Reference to related provision.--For a 
        provision prohibiting the adjustment of premium or contribution 
        amounts for a group under a group health plan on the basis of 
        predictive genetic information (including information about a 
        request for or receipt of genetic services), see section 
        2707.''.</DELETED>
                <DELETED>    (C) Limitation on collection and 
                disclosure of predictive genetic information.--Section 
                2702 of the Public Health Service Act (42 U.S.C. 300gg-
                1) is amended by adding at the end the 
                following:</DELETED>
<DELETED>    ``(c) Collection of Predictive Genetic Information.--
</DELETED>
        <DELETED>    ``(1) Limitation on requesting or requiring 
        predictive genetic information.--Except as provided in 
        paragraph (2), a group health plan, or a health insurance 
        issuer offering health insurance coverage in connection with a 
        group health plan, shall not request or require predictive 
        genetic information concerning an individual or a family member 
        of the individual (including information about a request for or 
        receipt of genetic services).</DELETED>
        <DELETED>    ``(2) Information needed for diagnosis, treatment, 
        or payment.--</DELETED>
                <DELETED>    ``(A) In general.--Notwithstanding 
                paragraph (1), a group health plan or health insurance 
                issuer that provides health care items and services to 
                an individual or dependent may request (but may not 
                require) that such individual or dependent disclose, or 
                authorize the collection or disclosure of, predictive 
                genetic information for purposes of diagnosis, 
                treatment, or payment relating to the provision of 
                health care items and services to such individual or 
                dependent.</DELETED>
                <DELETED>    ``(B) Notice of confidentiality practices 
                and description of safeguards.--As a part of a request 
                under subparagraph (A), the group health plan or health 
                insurance issuer shall provide to the individual or 
                dependent a description of the procedures in place to 
                safeguard the confidentiality, as described in sections 
                213 and 221 of the Patients' Bill of Rights Act, of 
                such individually identifiable 
                information.''.</DELETED>
        <DELETED>    (2) Definitions.--Section 2791(d) of the Public 
        Health Service Act (42 U.S.C. 300gg-91(d)) is amended by adding 
        at the end the following:</DELETED>
        <DELETED>    ``(15) Family member.--The term `family member' 
        means, with respect to an individual--</DELETED>
                <DELETED>    ``(A) the spouse of the 
                individual;</DELETED>
                <DELETED>    ``(B) a dependent child of the individual, 
                including a child who is born to or placed for adoption 
                with the individual; and</DELETED>
                <DELETED>    ``(C) all other individuals related by 
                blood to the individual or the spouse or child 
                described in subparagraph (A) or (B).</DELETED>
        <DELETED>    ``(16) Genetic information.--The term `genetic 
        information' means information about genes, gene products, or 
        inherited characteristics that may derive from an individual or 
        a family member.</DELETED>
        <DELETED>    ``(17) Genetic services.--The term `genetic 
        services' means health services provided to obtain, assess, or 
        interpret genetic information for diagnostic and therapeutic 
        purposes, and for genetic education and counseling.</DELETED>
        <DELETED>    ``(18) Predictive genetic information.--</DELETED>
                <DELETED>    ``(A) In general.--The term `predictive 
                genetic information' means--</DELETED>
                        <DELETED>    ``(i) information about an 
                        individual's genetic tests which is associated 
                        with a statistically significant increased risk 
                        of developing a disease or disorder;</DELETED>
                        <DELETED>    ``(ii) information about genetic 
                        tests of family members of the individual; 
                        or</DELETED>
                        <DELETED>    ``(iii) information about the 
                        occurrence of a disease or disorder in family 
                        members that predicts a statistically 
                        significant increased risk of a disease or 
                        disorder in the individual.</DELETED>
                <DELETED>    ``(B) Exceptions.--The term `predictive 
                genetic information' shall not include--</DELETED>
                        <DELETED>    ``(i) information about the sex or 
                        age of the individual;</DELETED>
                        <DELETED>    ``(ii) information derived from 
                        routine physical tests, such as the chemical, 
                        blood, or urine analyses of the individual, 
                        unless such analyses are genetic tests; 
                        and</DELETED>
                        <DELETED>    ``(iii) information about physical 
                        exams of the individual and other information 
                        relevant to determining the current health 
                        status of the individual so long as such 
                        information does not include information 
                        described in clauses (i), (ii), or (iii) of 
                        subparagraph (A).</DELETED>
        <DELETED>    ``(19) Genetic test.--The term `genetic test' 
        means the analysis of human DNA, RNA, chromosomes, proteins, 
        and certain metabolites, in order to detect disease-related 
        genotypes, mutations, phenotypes, or karyotypes.''.</DELETED>
<DELETED>    (b) Amendment Relating to the Individual Market.--The 
first subpart 3 of part B of title XXVII of the Public Health Service 
Act (42 U.S.C. 300gg-11 et seq.) (relating to other requirements), as 
amended by the Omnibus Consolidated and Emergency Supplemental 
Appropriations Act, 1999 (Public Law 105-277) is amended--</DELETED>
        <DELETED>    (1) by redesignating such subpart as subpart 2; 
        and</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>

<DELETED>``SEC. 2753. PROHIBITION OF HEALTH DISCRIMINATION ON THE BASIS 
              OF PREDICTIVE GENETIC INFORMATION.</DELETED>

<DELETED>    ``(a) Prohibition on Predictive Genetic Information as a 
Condition of Eligibility.--A health insurance issuer offering health 
insurance coverage in the individual market may not use predictive 
genetic information as a condition of eligibility of an individual to 
enroll in individual health insurance coverage (including information 
about a request for or receipt of genetic services).</DELETED>
<DELETED>    ``(b) Prohibition on Predictive Genetic Information in 
Setting Premium Rates.--A health insurance issuer offering health 
insurance coverage in the individual market shall not adjust premium 
rates for individuals on the basis of predictive genetic information 
concerning such an enrollee or a family member of the enrollee 
(including information about a request for or receipt of genetic 
services).</DELETED>
<DELETED>    ``(c) Collection of Predictive Genetic Information.--
</DELETED>
        <DELETED>    ``(1) Limitation on requesting or requiring 
        predictive genetic information.--Except as provided in 
        paragraph (2), a health insurance issuer offering health 
        insurance coverage in the individual market shall not request 
        or require predictive genetic information concerning an 
        individual or a family member of the individual (including 
        information about a request for or receipt of genetic 
        services).</DELETED>
        <DELETED>    ``(2) Information needed for diagnosis, treatment, 
        or payment.--</DELETED>
                <DELETED>    ``(A) in general.--Notwithstanding 
                paragraph (1), a health insurance issuer that provides 
                health care items and services to an individual or 
                dependent may request (but may not require) that such 
                individual or dependent disclose, or authorize the 
                collection or disclosure of, predictive genetic 
                information for purposes of diagnosis, treatment, or 
                payment relating to the provision of health care items 
                and services to such individual or dependent.</DELETED>
                <DELETED>    ``(B) Notice of confidentiality practices 
                and description of safeguards.--As a part of a request 
under subparagraph (A), the health insurance issuer shall provide to 
the individual or dependent a description of the procedures in place to 
safeguard the confidentiality, as described in sections 213 and 221 of 
the Patients' Bill of Rights Act, of such individually identifiable 
information.''.</DELETED>
<DELETED>    (c) Effective Date.--The amendments made by this section 
shall apply with respect to--</DELETED>
        <DELETED>    (1) group health plans, and health insurance 
        coverage offered in connection with group health plans, for 
        plan years beginning after 1 year after the date of enactment 
        of this Act; and</DELETED>
        <DELETED>    (2) health insurance coverage offered, sold, 
        issued, renewed, in effect, or operated in the individual 
        market after 1 year after the date of enactment of this 
        Act.</DELETED>

      <DELETED>TITLE IV--HEALTHCARE RESEARCH AND QUALITY</DELETED>

<DELETED>SEC. 401. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Healthcare Research and 
Quality Act of 1999''.</DELETED>

<DELETED>SEC. 402. AMENDMENT TO THE PUBLIC HEALTH SERVICE 
              ACT.</DELETED>

<DELETED>    Title IX of the Public Health Service Act (42 U.S.C. 299 
et seq.) is amended to read as follows:</DELETED>

        <DELETED>``TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND 
                           QUALITY</DELETED>

     <DELETED>``PART A--ESTABLISHMENT AND GENERAL DUTIES</DELETED>

<DELETED>``SEC. 901. MISSION AND DUTIES.</DELETED>

<DELETED>    ``(a) In General.--There is established within the Public 
Health Service an agency to be known as the Agency for Healthcare 
Research and Quality. In carrying out this subsection, the Secretary 
shall redesignate the Agency for Health Care Policy and Research as the 
Agency for Healthcare Research and Quality.</DELETED>
<DELETED>    ``(b) Mission.--The purpose of the Agency is to enhance 
the quality, appropriateness, and effectiveness of healthcare services, 
and access to such services, through the establishment of a broad base 
of scientific research and through the promotion of improvements in 
clinical and health system practice, including the prevention of 
diseases and other health conditions. The Agency shall promote 
healthcare quality improvement by--</DELETED>
        <DELETED>    ``(1) conducting and supporting research that 
        develops and presents scientific evidence regarding all aspects 
        of healthcare, including--</DELETED>
                <DELETED>    ``(A) the development and assessment of 
                methods for enhancing patient participation in their 
                own care and for facilitating shared patient-physician 
                decision-making;</DELETED>
                <DELETED>    ``(B) the outcomes, effectiveness, and 
                cost-effectiveness of healthcare practices, including 
                preventive measures and primary, acute and long-term 
                care;</DELETED>
                <DELETED>    ``(C) existing and innovative 
                technologies;</DELETED>
                <DELETED>    ``(D) the costs and utilization of, and 
                access to healthcare;</DELETED>
                <DELETED>    ``(E) the ways in which healthcare 
                services are organized, delivered, and financed and the 
                interaction and impact of these factors on the quality 
                of patient care;</DELETED>
                <DELETED>    ``(F) methods for measuring quality and 
                strategies for improving quality; and</DELETED>
                <DELETED>    ``(G) ways in which patients, consumers, 
                purchasers, and practitioners acquire new information 
                about best practices and health benefits, the 
                determinants and impact of their use of this 
                information;</DELETED>
        <DELETED>    ``(2) synthesizing and disseminating available 
        scientific evidence for use by patients, consumers, 
        practitioners, providers, purchasers, policy makers, and 
        educators; and</DELETED>
        <DELETED>    ``(3) advancing private and public efforts to 
        improve healthcare quality.</DELETED>
<DELETED>    ``(c) Requirements With Respect to Rural Areas and 
Priority Populations.--In carrying out subsection (b), the Director 
shall undertake and support research, demonstration projects, and 
evaluations with respect to--</DELETED>
        <DELETED>    ``(1) the delivery of health services in rural 
        areas (including frontier areas);</DELETED>
        <DELETED>    ``(2) health services for low-income groups, and 
        minority groups;</DELETED>
        <DELETED>    ``(3) the health of children;</DELETED>
        <DELETED>    ``(4) the elderly; and</DELETED>
        <DELETED>    ``(5) people with special healthcare needs, 
        including disabilities, chronic care and end-of-life 
        healthcare.</DELETED>
<DELETED>    ``(d) Appointment of Director.--There shall be at the head 
of the Agency an official to be known as the Director for Healthcare 
Research and Quality. The Director shall be appointed by the Secretary. 
The Secretary, acting through the Director, shall carry out the 
authorities and duties established in this title.</DELETED>

<DELETED>``SEC. 902. GENERAL AUTHORITIES.</DELETED>

<DELETED>    ``(a) In General.--In carrying out section 901(b), the 
Director shall support demonstration projects, conduct and support 
research, evaluations, training, research networks, multi-disciplinary 
centers, technical assistance, and the dissemination of information, on 
healthcare, and on systems for the delivery of such care, including 
activities with respect to--</DELETED>
        <DELETED>    ``(1) the quality, effectiveness, efficiency, 
        appropriateness and value of healthcare services;</DELETED>
        <DELETED>    ``(2) quality measurement and 
        improvement;</DELETED>
        <DELETED>    ``(3) the outcomes, cost, cost-effectiveness, and 
        use of healthcare services and access to such 
        services;</DELETED>
        <DELETED>    ``(4) clinical practice, including primary care 
        and practice-oriented research;</DELETED>
        <DELETED>    ``(5) healthcare technologies, facilities, and 
        equipment;</DELETED>
        <DELETED>    ``(6) healthcare costs, productivity, 
        organization, and market forces;</DELETED>
        <DELETED>    ``(7) health promotion and disease prevention, 
        including clinical preventive services;</DELETED>
        <DELETED>    ``(8) health statistics, surveys, database 
        development, and epidemiology; and</DELETED>
        <DELETED>    ``(9) medical liability.</DELETED>
<DELETED>    ``(b) Health Services Training Grants.--</DELETED>
        <DELETED>    ``(1) In general.--The Director may provide 
        training grants in the field of health services research 
        related to activities authorized under subsection (a), to 
        include pre- and post-doctoral fellowships and training 
        programs, young investigator awards, and other programs and 
        activities as appropriate. In carrying out this subsection, the 
        Director shall make use of funds made available under section 
        487.</DELETED>
        <DELETED>    ``(2) Requirements.--In developing priorities for 
        the allocation of training funds under this subsection, the 
        Director shall take into consideration shortages in the number 
        of trained researchers addressing the priority 
        populations.</DELETED>
<DELETED>    ``(c) Multidisciplinary Centers.--The Director may provide 
financial assistance to assist in meeting the costs of planning and 
establishing new centers, and operating existing and new centers, for 
multidisciplinary health services research, demonstration projects, 
evaluations, training, and policy analysis with respect to the matters 
referred to in subsection (a).</DELETED>
<DELETED>    ``(d) Relation to Certain Authorities Regarding Social 
Security.--Activities authorized in this section may include, and shall 
be appropriately coordinated with experiments, demonstration projects, 
and other related activities authorized by the Social Security Act and 
the Social Security Amendments of 1967. Activities under subsection 
(a)(2) of this section that affect the programs under titles XVIII, XIX 
and XXI of the Social Security Act shall be carried out consistent with 
section 1142 of such Act.</DELETED>
<DELETED>    ``(e) Disclaimer.--The Agency shall not mandate national 
standards of clinical practice or quality healthcare standards. 
Recommendations resulting from projects funded and published by the 
Agency shall include a corresponding disclaimer.</DELETED>
<DELETED>    ``(f) Rule of Construction.--Nothing in this section shall 
be construed to imply that the Agency's role is to mandate a national 
standard or specific approach to quality measurement and reporting. In 
research and quality improvement activities, the Agency shall consider 
a wide range of choices, providers, healthcare delivery systems, and 
individual preferences.</DELETED>

      <DELETED>``PART B--HEALTHCARE IMPROVEMENT RESEARCH</DELETED>

<DELETED>``SEC. 911. HEALTHCARE OUTCOME IMPROVEMENT RESEARCH.</DELETED>

<DELETED>    ``(a) Evidence Rating Systems.--In collaboration with 
experts from the public and private sector, the Agency shall identify 
and disseminate methods or systems used to assess healthcare research 
results, particularly to rate the strength of the scientific evidence 
behind healthcare practice, recommendations in the research literature, 
and technology assessments. The Agency shall make methods or systems 
for evidence rating widely available. Agency publications containing 
healthcare recommendations shall indicate the level of substantiating 
evidence using such methods or systems.</DELETED>
<DELETED>    ``(b) Healthcare Improvement Research Centers and 
Provider-Based Research Networks.--</DELETED>
        <DELETED>    ``(1) In general.--In order to address the full 
        continuum of care and outcomes research, to link research to 
        practice improvement, and to speed the dissemination of 
        research findings to community practice settings, the Agency 
        shall employ research strategies and mechanisms that will link 
        research directly with clinical practice in geographically 
        diverse locations throughout the United States, including--
        </DELETED>
                <DELETED>    ``(A) Healthcare Improvement Research 
                Centers that combine demonstrated multidisciplinary 
                expertise in outcomes or quality improvement research 
                with linkages to relevant sites of care;</DELETED>
                <DELETED>    ``(B) Provider-based Research Networks, 
                including plan, facility, or delivery system sites of 
                care (especially primary care), that can evaluate and 
                promote quality improvement; and</DELETED>
                <DELETED>    ``(C) other innovative mechanisms or 
                strategies to link research with clinical 
                practice.</DELETED>
        <DELETED>    ``(2) Requirements.--The Director is authorized to 
        establish the requirements for entities applying for grants 
        under this subsection.</DELETED>

<DELETED>``SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE 
              ORGANIZATION AND DELIVERY.</DELETED>

<DELETED>    ``(a) Support for Efforts To Develop Information on 
Quality.--</DELETED>
        <DELETED>    ``(1) Scientific and technical support.--In its 
        role as the principal agency for healthcare research and 
        quality, the Agency may provide scientific and technical 
        support for private and public efforts to improve healthcare 
        quality, including the activities of accrediting 
        organizations.</DELETED>
        <DELETED>    ``(2) Role of the agency.--With respect to 
        paragraph (1), the role of the Agency shall include--</DELETED>
                <DELETED>    ``(A) the identification and assessment 
                of--</DELETED>
                        <DELETED>    ``(i) methods for the evaluation 
                        of the health of enrollees in health plans by 
                        type of plan, provider, and provider 
                        arrangements; and</DELETED>
                        <DELETED>    ``(ii) other populations, 
                        including those receiving long-term care 
                        services;</DELETED>
                <DELETED>    ``(B) the ongoing development, testing, 
                and dissemination of quality measures, including 
                measures of health and functional outcomes;</DELETED>
                <DELETED>    ``(C) the compilation and dissemination of 
                healthcare quality measures developed in the private 
                and public sector;</DELETED>
                <DELETED>    ``(D) assistance in the development of 
                improved healthcare information systems;</DELETED>
                <DELETED>    ``(E) the development of survey tools for 
                the purpose of measuring participant and beneficiary 
                assessments of their healthcare; and</DELETED>
                <DELETED>    ``(F) identifying and disseminating 
                information on mechanisms for the integration of 
                information on quality into purchaser and consumer 
                decision-making processes.</DELETED>
<DELETED>    ``(b) Centers for Education and Research on 
Therapeutics.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary, acting through 
        the Director and in consultation with the Commissioner of Food 
        and Drugs, shall establish a program for the purpose of making 
        one or more grants for the establishment and operation of one 
        or more centers to carry out the activities specified in 
        paragraph (2).</DELETED>
        <DELETED>    ``(2) Required activities.--The activities 
        referred to in this paragraph are the following:</DELETED>
                <DELETED>    ``(A) The conduct of state-of-the-art 
                clinical research for the following purposes:</DELETED>
                        <DELETED>    ``(i) To increase awareness of--
                        </DELETED>
                                <DELETED>    ``(I) new uses of drugs, 
                                biological products, and 
                                devices;</DELETED>
                                <DELETED>    ``(II) ways to improve the 
                                effective use of drugs, biological 
                                products, and devices; and</DELETED>
                                <DELETED>    ``(III) risks of new uses 
                                and risks of combinations of drugs and 
                                biological products.</DELETED>
                        <DELETED>    ``(ii) To provide objective 
                        clinical information to the following 
                        individuals and entities:</DELETED>
                                <DELETED>    ``(I) Healthcare 
                                practitioners and other providers of 
                                Healthcare goods or services.</DELETED>
                                <DELETED>    ``(II) Pharmacists, 
                                pharmacy benefit managers and 
                                purchasers.</DELETED>
                                <DELETED>    ``(III) Health maintenance 
                                organizations and other managed 
                                healthcare organizations.</DELETED>
                                <DELETED>    ``(IV) Healthcare insurers 
                                and governmental agencies.</DELETED>
                                <DELETED>    ``(V) Patients and 
                                consumers.</DELETED>
                        <DELETED>    ``(iii) To improve the quality of 
                        healthcare while reducing the cost of 
                        Healthcare through--</DELETED>
                                <DELETED>    ``(I) an increase in the 
                                appropriate use of drugs, biological 
                                products, or devices; and</DELETED>
                                <DELETED>    ``(II) the prevention of 
                                adverse effects of drugs, biological 
                                products, and devices and the 
                                consequences of such effects, such as 
                                unnecessary hospitalizations.</DELETED>
                <DELETED>    ``(B) The conduct of research on the 
                comparative effectiveness, cost-effectiveness, and 
                safety of drugs, biological products, and 
                devices.</DELETED>
                <DELETED>    ``(C) Such other activities as the 
                Secretary determines to be appropriate, except that a 
                grant may not be expended to assist the Secretary in 
                the review of new drugs.</DELETED>
<DELETED>    ``(c) Reducing Errors in Medicine.--The Director shall 
conduct and support research and build private-public partnerships to--
</DELETED>
        <DELETED>    ``(1) identify the causes of preventable 
        healthcare errors and patient injury in healthcare 
        delivery;</DELETED>
        <DELETED>    ``(2) develop, demonstrate, and evaluate 
        strategies for reducing errors and improving patient safety; 
        and</DELETED>
        <DELETED>    ``(3) promote the implementation of effective 
        strategies throughout the healthcare industry.</DELETED>

<DELETED>``SEC. 913. INFORMATION ON QUALITY AND COST OF CARE.</DELETED>

<DELETED>    ``(a) In General.--In carrying out 902(a), the Director 
shall--</DELETED>
        <DELETED>    ``(1) collect data on a nationally representative 
        sample of the population on the cost, use and, for fiscal year 
        2000 and subsequent fiscal years, quality of healthcare, 
        including the types of healthcare services Americans use, their 
        access to healthcare services, frequency of use, how much is 
        paid for the services used, the source of those payments, the 
        types and costs of private health insurance, access, 
        satisfaction, and quality of care for the general population 
        and also for children, uninsured persons, poor and near-poor 
        individuals, and persons with special healthcare 
        needs;</DELETED>
        <DELETED>    ``(2) develop databases and tools that enable 
        States to track the quality, access, and use of healthcare 
        services provided to their residents; and</DELETED>
        <DELETED>    ``(3) enter into agreements with public or private 
        entities to use, link, or acquire databases for research 
        authorized under this title.</DELETED>
<DELETED>    ``(b) Quality and Outcomes Information.--</DELETED>
        <DELETED>    ``(1) In general.--To enhance the understanding of 
        the quality of care, the determinants of health outcomes and 
        functional status, the needs of special populations as well as 
        an understanding of these changes over time, their relationship 
        to healthcare access and use, and to monitor the overall 
        national impact of Federal and State policy changes on 
        healthcare, the Director, beginning in fiscal year 2000, shall 
        ensure that the survey conducted under subsection (a)(1) will--
        </DELETED>
                <DELETED>    ``(A) provide information on the quality 
                of care and patient outcomes for frequently occurring 
                clinical conditions for a nationally representative 
                sample of the population; and</DELETED>
                <DELETED>    ``(B) provide reliable national estimates 
                for children and persons with special healthcare needs 
                through the use of supplements or periodic expansions 
                of the survey.</DELETED>
        <DELETED>In expanding the Medical Expenditure Panel Survey, as 
        in existence on the date of enactment of this title) in fiscal 
        year 2000 to collect information on the quality of care, the 
        Director shall take into account any outcomes measurements 
        generally collected by private sector accreditation 
        organizations.</DELETED>
        <DELETED>    ``(2) Annual report.--Beginning in fiscal year 
        2002, the Secretary, acting through the Director, shall submit 
        to Congress an annual report on national trends in the quality 
        of healthcare provided to the American people.</DELETED>

<DELETED>``SEC. 914. INFORMATION SYSTEMS FOR HEALTHCARE 
              IMPROVEMENT.</DELETED>

<DELETED>    ``In order to foster a range of innovative approaches to 
the management and communication of health information, the Agency 
shall support research, evaluations and initiatives to advance--
</DELETED>
        <DELETED>    ``(1) the use of information systems for the study 
        of healthcare quality, including the generation of both 
        individual provider and plan-level comparative performance 
        data;</DELETED>
        <DELETED>    ``(2) training for healthcare practitioners and 
        researchers in the use of information systems;</DELETED>
        <DELETED>    ``(3) the creation of effective linkages between 
        various sources of health information, including the 
        development of information networks;</DELETED>
        <DELETED>    ``(4) the delivery and coordination of evidence-
        based healthcare services, including the use of real-time 
        healthcare decision-support programs;</DELETED>
        <DELETED>    ``(5) the structure, content, definition, and 
        coding of health information data and medical vocabularies in 
        consultation with appropriate Federal and private 
        entities;</DELETED>
        <DELETED>    ``(6) the use of computer-based health records in 
        outpatient and inpatient settings as a personal health record 
        for individual health assessment and maintenance, and for 
        monitoring public health and outcomes of care within 
        populations; and</DELETED>
        <DELETED>    ``(7) the protection of individually identifiable 
        information in health services research and healthcare quality 
        improvement.</DELETED>

<DELETED>``SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND ACCESS IN 
              UNDERSERVED AREAS.</DELETED>

<DELETED>    ``(a) Preventive Services Task Force.--</DELETED>
        <DELETED>    ``(1) Purpose.--The Agency shall provide ongoing 
        administrative, research, and technical support for the 
        operation of the Preventive Services Task Force. The Agency 
        shall coordinate and support the dissemination of the 
        Preventive Services Task Force recommendations.</DELETED>
        <DELETED>    ``(2) Operation.--The Preventive Services Task 
        Force shall review the scientific evidence related to the 
        effectiveness, appropriateness, and cost-effectiveness of 
        clinical preventive services for the purpose of developing 
        recommendations, and updating previous recommendations, 
        regarding their usefulness in daily clinical practice. In 
        carrying out its responsibilities under paragraph (1), the Task 
        Force shall not be subject to the provisions of Appendix 2 of 
        title 5, United States Code.</DELETED>
<DELETED>    ``(b) Primary Care Research.--</DELETED>
        <DELETED>    ``(1) In general.--There is established within the 
        Agency a Center for Primary Care Research (referred to in this 
        subsection as the `Center') that shall serve as the principal 
        source of funding for primary care research in the Department 
        of Health and Human Services. For purposes of this paragraph, 
        primary care research focuses on the first contact when illness 
        or health concerns arise, the diagnosis, treatment or referral 
        to specialty care, preventive care, and the relationship 
        between the clinician and the patient in the context of the 
        family and community.</DELETED>
        <DELETED>    ``(2) Research.--In carrying out this section, the 
        Center shall conduct and support research on--</DELETED>
                <DELETED>    ``(A) the nature and characteristics of 
                primary care practice;</DELETED>
                <DELETED>    ``(B) the management of commonly occurring 
                clinical problems;</DELETED>
                <DELETED>    ``(C) the management of undifferentiated 
                clinical problems; and</DELETED>
                <DELETED>    ``(D) the continuity and coordination of 
                health services.</DELETED>
        <DELETED>    ``(3) Demonstration.--The Agency shall support 
        demonstrations into the use of new information tools aimed at 
        improving shared decision-making between patients and their 
        care-givers.</DELETED>

<DELETED>``SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY 
              INNOVATION.</DELETED>

<DELETED>    ``(a) In General.--The Director shall promote innovation 
in evidence-based clinical practice and healthcare technologies by--
</DELETED>
        <DELETED>    ``(1) conducting and supporting research on the 
        development, diffusion, and use of healthcare 
        technology;</DELETED>
        <DELETED>    ``(2) developing, evaluating, and disseminating 
        methodologies for assessments of healthcare practices and 
        healthcare technologies;</DELETED>
        <DELETED>    ``(3) conducting intramural and supporting 
        extramural assessments of existing and new healthcare practices 
        and technologies;</DELETED>
        <DELETED>    ``(4) promoting education, training, and providing 
        technical assistance in the use of healthcare practice and 
        healthcare technology assessment methodologies and results; 
        and</DELETED>
        <DELETED>    ``(5) working with the National Library of 
        Medicine and the public and private sector to develop an 
        electronic clearinghouse of currently available assessments and 
        those in progress.</DELETED>
<DELETED>    ``(b) Specification of Process.--</DELETED>
        <DELETED>    ``(1) In general.--Not later than December 31, 
        2000, the Director shall develop and publish a description of 
        the methods used by the Agency and its contractors for practice 
        and technology assessment.</DELETED>
        <DELETED>    ``(2) Consultations.--In carrying out this 
        subsection, the Director shall cooperate and consult with the 
        Assistance Secretary for Health, the Administrator of the 
        Health Care Financing Administration, the Director of the 
        National Institutes of Health, the Commissioner of Food and 
        Drugs, and the heads of any other interested Federal department 
        or agency, professional societies, and other private and public 
        entities.</DELETED>
        <DELETED>    ``(3) Methodology.--The methods employed in 
        practice and technology assessments under paragraph (1) shall 
        consider--</DELETED>
                <DELETED>    ``(A) safety, efficacy, and 
                effectiveness;</DELETED>
                <DELETED>    ``(B) legal, social, and ethical 
                implications;</DELETED>
                <DELETED>    ``(C) costs, benefits, and cost-
                effectiveness;</DELETED>
                <DELETED>    ``(D) comparisons to alternative 
                technologies and practices; and</DELETED>
                <DELETED>    ``(E) requirements of Food and Drug 
                Administration approval to avoid duplication.</DELETED>
<DELETED>    ``(c) Specific Assessments.--</DELETED>
        <DELETED>    ``(1) In general.--The Director shall conduct or 
        support specific assessments of healthcare technologies and 
        practices.</DELETED>
        <DELETED>    ``(2) Requests for assessments.--The Director is 
        authorized to conduct or support assessments, on a reimbursable 
        basis, for the Health Care Financing Administration, the 
        Department of Defense, the Department of Veterans Affairs, the 
        Office of Personnel Management, and other public or private 
        entities.</DELETED>
        <DELETED>    ``(3) Grants and contracts.--In addition to 
        conducting assessments, the Director may make grants to, or 
        enter into cooperative agreements or contracts with, entities 
        described in paragraph (4) for the purpose of conducting 
        assessments of experimental, emerging, existing, or potentially 
        outmoded healthcare technologies, and for related 
        activities.</DELETED>
        <DELETED>    ``(4) Eligible entities.--An entity described in 
        this paragraph is an entity that is determined to be 
        appropriate by the Director, including academic medical 
        centers, research institutions, professional organizations, 
        third party payers, other governmental agencies, and consortia 
        of appropriate research entities established for the purpose of 
        conducting technology assessments.</DELETED>

<DELETED>``SEC. 917. COORDINATION OF FEDERAL GOVERNMENT QUALITY 
              IMPROVEMENT EFFORTS.</DELETED>

<DELETED>    ``(a) Requirement.--</DELETED>
        <DELETED>    ``(1) In general.--To avoid duplication and ensure 
        that Federal resources are used efficiently and effectively, 
        the Secretary, acting through the Director, shall coordinate 
        all research, evaluations, and demonstrations related to health 
        services research and quality measurement and improvement 
        activities undertaken and supported by the Federal 
        Government.</DELETED>
        <DELETED>    ``(2) Specific activities.--The Director, in 
        collaboration with the appropriate Federal officials 
        representing all concerned executive agencies and departments, 
        shall develop and manage a process to--</DELETED>
                <DELETED>    ``(A) improve interagency coordination, 
                priority setting, and the use and sharing of research 
                findings and data pertaining to Federal quality 
                improvement programs and health services 
                research;</DELETED>
                <DELETED>    ``(B) strengthen the research information 
                infrastructure, including databases, pertaining to 
                Federal health services research and healthcare quality 
                improvement initiatives;</DELETED>
                <DELETED>    ``(C) set specific goals for participating 
                agencies and departments to further health services 
                research and healthcare quality improvement; 
                and</DELETED>
                <DELETED>    ``(D) strengthen the management of Federal 
                healthcare quality improvement programs.</DELETED>
<DELETED>    ``(b) Study by the Institute of Medicine.--</DELETED>
        <DELETED>    ``(1) In general.--To provide the Department of 
        Health and Human Services with an independent, external review 
        of its quality oversight, and quality research programs, the 
        Secretary shall enter into a contract with the Institute of 
        Medicine--</DELETED>
                <DELETED>    ``(A) to describe and evaluate current 
                quality improvement research and monitoring processes 
                through--</DELETED>
                        <DELETED>    ``(i) an overview of pertinent 
                        health services research activities and quality 
                        improvement efforts including those currently 
                        performed by the peer review organizations and 
                        the exploration of additional activities that 
                        could be undertaken by the peer review 
                        organizations to improve quality;</DELETED>
                        <DELETED>    ``(ii) an analysis of the various 
                        partnership activities that the Department of 
                        Health and Human Services has pursued with 
private sector accreditation and other quality measurement 
organizations;</DELETED>
                        <DELETED>    ``(iii) the exploration of 
                        programmatic areas where partnership activities 
                        between the Federal Government and the private 
                        sector or within the Federal Government could 
                        be pursued to improve quality oversight of the 
                        medicare, medicaid and child health insurance 
                        programs under titles XVIII, XIX and XXI of the 
                        Social Security Act; and</DELETED>
                        <DELETED>    ``(iv) an identification of 
                        opportunities for enhancing health system 
                        efficiency through simplification and reduction 
                        in redundancy of Federal agency quality 
                        improvement efforts, including areas in which 
                        Federal efforts unnecessarily duplicate 
                        existing private sector efforts; and</DELETED>
                <DELETED>    ``(B) to identify options and make 
                recommendations to improve the efficiency and 
                effectiveness of such quality improvement programs 
                through--</DELETED>
                        <DELETED>    ``(i) the improved coordination of 
                        activities across the medicare, medicaid and 
                        child health insurance programs under titles 
                        XVIII, XIX and XXI of the Social Security Act 
                        and various health services research 
                        programs;</DELETED>
                        <DELETED>    ``(ii) the strengthening of 
                        patient choice and participation by 
                        incorporating state-of-the-art quality 
                        monitoring tools and making information on 
                        quality available; and</DELETED>
                        <DELETED>    ``(iii) the enhancement of the 
                        most effective programs, consolidation as 
                        appropriate, and elimination of duplicative 
                        activities within various federal 
                        agencies.</DELETED>
        <DELETED>    ``(2) Requirements.--</DELETED>
                <DELETED>    ``(A) In general.--The Secretary shall 
                enter into a contract with the Institute of Medicine 
                for the preparation--</DELETED>
                        <DELETED>    ``(i) not later than 12 months 
                        after the date of enactment of this title, of a 
                        report providing an overview of the quality 
                        improvement programs of the Department of 
                        Health and Human Services for the medicare, 
                        medicaid, and CHIP programs under titles XVIII, 
                        XIX, and XXI of the Social Security Act; 
                        and</DELETED>
                        <DELETED>    ``(ii) not later than 24 months 
                        after the date of enactment of this title, of a 
                        final report containing 
                        recommendations.</DELETED>
                <DELETED>    ``(B) Reports.--The Secretary shall submit 
                the reports described in subparagraph (A) to the 
                Committee on Finance and the Committee on Health, 
                Education, Labor, and Pensions of the Senate and the 
                Committee on Ways and Means and the Committee on 
                Commerce of the House of Representatives.</DELETED>

            <DELETED>``PART C--GENERAL PROVISIONS</DELETED>

<DELETED>``SEC. 921. ADVISORY COUNCIL FOR HEALTHCARE RESEARCH AND 
              QUALITY.</DELETED>

<DELETED>    ``(a) Establishment.--There is established an advisory 
council to be known as the Advisory Council for Healthcare Research and 
Quality.</DELETED>
<DELETED>    ``(b) Duties.--</DELETED>
        <DELETED>    ``(1) In general.--The Advisory Council shall 
        advise the Secretary and the Director with respect to 
        activities proposed or undertaken to carry out the purpose of 
        the Agency under section 901(b).</DELETED>
        <DELETED>    ``(2) Certain recommendations.--Activities of the 
        Advisory Council under paragraph (1) shall include making 
        recommendations to the Director regarding--</DELETED>
                <DELETED>    ``(A) priorities regarding healthcare 
                research, especially studies related to quality, 
                outcomes, cost and the utilization of, and access to, 
                healthcare services;</DELETED>
                <DELETED>    ``(B) the field of healthcare research and 
                related disciplines, especially issues related to 
                training needs, and dissemination of information 
                pertaining to healthcare quality; and</DELETED>
                <DELETED>    ``(C) the appropriate role of the Agency 
                in each of these areas in light of private sector 
                activity and identification of opportunities for 
                public-private sector partnerships.</DELETED>
<DELETED>    ``(c) Membership.--</DELETED>
        <DELETED>    ``(1) In general.--The Advisory Council shall, in 
        accordance with this subsection, be composed of appointed 
        members and ex officio members. All members of the Advisory 
        Council shall be voting members other than the individuals 
        designated under paragraph (3)(B) as ex officio 
        members.</DELETED>
        <DELETED>    ``(2) Appointed members.--The Secretary shall 
        appoint to the Advisory Council 21 appropriately qualified 
        individuals. At least 17 members of the Advisory Council shall 
        be representatives of the public who are not officers or 
        employees of the United States. The Secretary shall ensure that 
the appointed members of the Council, as a group, are representative of 
professions and entities concerned with, or affected by, activities 
under this title and under section 1142 of the Social Security Act. Of 
such members--</DELETED>
                <DELETED>    ``(A) 4 shall be individuals distinguished 
                in the conduct of research, demonstration projects, and 
                evaluations with respect to healthcare;</DELETED>
                <DELETED>    ``(B) 4 shall be individuals distinguished 
                in the practice of medicine of which at least 1 shall 
                be a primary care practitioner;</DELETED>
                <DELETED>    ``(C) 3 shall be individuals distinguished 
                in the other health professions;</DELETED>
                <DELETED>    ``(D) 4 shall be individuals either 
                representing the private healthcare sector, including 
                health plans, providers, and purchasers or individuals 
                distinguished as administrators of healthcare delivery 
                systems;</DELETED>
                <DELETED>    ``(E) 4 shall be individuals distinguished 
                in the fields of healthcare quality improvement, 
                economics, information systems, law, ethics, business, 
                or public policy; and</DELETED>
                <DELETED>    ``(F) 2 shall be individuals representing 
                the interests of patients and consumers of 
                healthcare.</DELETED>
        <DELETED>    ``(3) Ex officio members.--The Secretary shall 
        designate as ex officio members of the Advisory Council--
        </DELETED>
                <DELETED>    ``(A) the Assistant Secretary for Health, 
                the Director of the National Institutes of Health, the 
                Director of the Centers for Disease Control and 
                Prevention, the Administrator of the Health Care 
                Financing Administration, the Assistant Secretary of 
                Defense (Health Affairs), and the Chief Medical Officer 
                of the Department of Veterans Affairs; and</DELETED>
                <DELETED>    ``(B) such other Federal officials as the 
                Secretary may consider appropriate.</DELETED>
<DELETED>    ``(d) Terms.--Members of the Advisory Council appointed 
under subsection (c)(2) shall serve for a term of 3 years. A member of 
the Council appointed under such subsection may continue to serve after 
the expiration of the term of the members until a successor is 
appointed.</DELETED>
<DELETED>    ``(e) Vacancies.--If a member of the Advisory Council 
appointed under subsection (c)(2) does not serve the full term 
applicable under subsection (d), the individual appointed to fill the 
resulting vacancy shall be appointed for the remainder of the term of 
the predecessor of the individual.</DELETED>
<DELETED>    ``(f) Chair.--The Director shall, from among the members 
of the Advisory Council appointed under subsection (c)(2), designate an 
individual to serve as the chair of the Advisory Council.</DELETED>
<DELETED>    ``(g) Meetings.--The Advisory Council shall meet not less 
than once during each discrete 4-month period and shall otherwise meet 
at the call of the Director or the chair.</DELETED>
<DELETED>    ``(h) Compensation and Reimbursement of Expenses.--
</DELETED>
        <DELETED>    ``(1) Appointed members.--Members of the Advisory 
        Council appointed under subsection (c)(2) shall receive 
        compensation for each day (including travel time) engaged in 
        carrying out the duties of the Advisory Council unless declined 
        by the member. Such compensation may not be in an amount in 
        excess of the maximum rate of basic pay payable for GS-18 of 
        the General Schedule.</DELETED>
        <DELETED>    ``(2) Ex officio members.--Officials designated 
        under subsection (c)(3) as ex officio members of the Advisory 
        Council may not receive compensation for service on the 
        Advisory Council in addition to the compensation otherwise 
        received for duties carried out as officers of the United 
        States.</DELETED>
<DELETED>    ``(i) Staff.--The Director shall provide to the Advisory 
Council such staff, information, and other assistance as may be 
necessary to carry out the duties of the Council.</DELETED>

<DELETED>``SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND 
              CONTRACTS.</DELETED>

<DELETED>    ``(a) Requirement of Review.--</DELETED>
        <DELETED>    ``(1) In general.--Appropriate technical and 
        scientific peer review shall be conducted with respect to each 
        application for a grant, cooperative agreement, or contract 
        under this title.</DELETED>
        <DELETED>    ``(2) Reports to director.--Each peer review group 
        to which an application is submitted pursuant to paragraph (1) 
        shall report its finding and recommendations respecting the 
        application to the Director in such form and in such manner as 
        the Director shall require.</DELETED>
<DELETED>    ``(b) Approval as Precondition of Awards.--The Director 
may not approve an application described in subsection (a)(1) unless 
the application is recommended for approval by a peer review group 
established under subsection (c).</DELETED>
<DELETED>    ``(c) Establishment of Peer Review Groups.--</DELETED>
        <DELETED>    ``(1) In general.--The Director shall establish 
        such technical and scientific peer review groups as may be 
        necessary to carry out this section. Such groups shall be 
        established without regard to the provisions of title 5, United 
        States Code, that govern appointments in the competitive 
        service, and without regard to the provisions of chapter 51, 
        and subchapter III of chapter 53, of such title that relate to 
        classification and pay rates under the General 
        Schedule.</DELETED>
        <DELETED>    ``(2) Membership.--The members of any peer review 
        group established under this section shall be appointed from 
        among individuals who by virtue of their training or experience 
        are eminently qualified to carry out the duties of such peer 
        review group. Officers and employees of the United States may 
        not constitute more than 25 percent of the membership of any 
        such group. Such officers and employees may not receive 
        compensation for service on such groups in addition to the 
        compensation otherwise received for these duties carried out as 
        such officers and employees.</DELETED>
        <DELETED>    ``(3) Duration.--Notwithstanding section 14(a) of 
        the Federal Advisory Committee Act, peer review groups 
        established under this section may continue in existence until 
        otherwise provided by law.</DELETED>
        <DELETED>    ``(4) Qualifications.--Members of any peer-review 
        group shall, at a minimum, meet the following 
        requirements:</DELETED>
                <DELETED>    ``(A) Such members shall agree in writing 
                to treat information received, pursuant to their work 
                for the group, as confidential information, except that 
                this subparagraph shall not apply to public records and 
                public information.</DELETED>
                <DELETED>    ``(B) Such members shall agree in writing 
                to recuse themselves from participation in the peer-
                review of specific applications which present a 
                potential personal conflict of interest or appearance 
                of such conflict, including employment in a directly 
                affected organization, stock ownership, or any 
                financial or other arrangement that might introduce 
                bias in the process of peer-review.</DELETED>
<DELETED>    ``(d) Authority for Procedural Adjustments in Certain 
Cases.--In the case of applications for financial assistance whose 
direct costs will not exceed $100,000, the Director may make 
appropriate adjustments in the procedures otherwise established by the 
Director for the conduct of peer review under this section. Such 
adjustments may be made for the purpose of encouraging the entry of 
individuals into the field of research, for the purpose of encouraging 
clinical practice-oriented or provider-based research, and for such 
other purposes as the Director may determine to be 
appropriate.</DELETED>
<DELETED>    ``(e) Regulations.--The Director may shall issue 
regulations for the conduct of peer review under this 
section.</DELETED>

<DELETED>``SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, 
              COLLECTION, AND DISSEMINATION OF DATA.</DELETED>

<DELETED>    ``(a) Standards With Respect to Utility of Data.--
</DELETED>
        <DELETED>    ``(1) In general.--To ensure the utility, 
        accuracy, and sufficiency of data collected by or for the 
        Agency for the purpose described in section 901(b), the 
        Director shall establish standards and methods for developing 
        and collecting such data, taking into consideration--</DELETED>
                <DELETED>    ``(A) other Federal health data collection 
                standards; and</DELETED>
                <DELETED>    ``(B) the differences between types of 
                healthcare plans, delivery systems, healthcare 
                providers, and provider arrangements.</DELETED>
        <DELETED>    ``(2) Relationship with other department 
        programs.--In any case where standards under paragraph (1) may 
        affect the administration of other programs carried out by the 
        Department of Health and Human Services, including the programs 
        under titles XVIII, XIX and XXI of the Social Security Act, 
        they shall be in the form of recommendations to the Secretary 
        for such program.</DELETED>
<DELETED>    ``(b) Statistics and Analyses.--The Director shall--
</DELETED>
        <DELETED>    ``(1) take appropriate action to ensure that 
        statistics and analyses developed under this title are of high 
        quality, timely, and duly comprehensive, and that the 
        statistics are specific, standardized, and adequately analyzed 
        and indexed; and</DELETED>
        <DELETED>    ``(2) publish, make available, and disseminate 
        such statistics and analyses on as wide a basis as is 
        practicable.</DELETED>
<DELETED>    ``(c) Authority Regarding Certain Requests.--Upon request 
of a public or private entity, the Director may conduct or support 
research or analyses otherwise authorized by this title pursuant to 
arrangements under which such entity will pay the cost of the services 
provided. Amounts received by the Director under such arrangements 
shall be available to the Director for obligation until 
expended.</DELETED>

<DELETED>``SEC. 924. DISSEMINATION OF INFORMATION.</DELETED>

<DELETED>    ``(a) In General.--The Director shall--</DELETED>
        <DELETED>    ``(1) without regard to section 501 of title 44, 
        United States Code, promptly publish, make available, and 
        otherwise disseminate, in a form understandable and on as broad 
        a basis as practicable so as to maximize its use, the results 
        of research, demonstration projects, and evaluations conducted 
        or supported under this title;</DELETED>
        <DELETED>    ``(2) ensure that information disseminated by the 
        Agency is science-based and objective and undertakes 
        consultation as necessary to assess the appropriateness and 
        usefulness of the presentation of information that is targeted 
        to specific audiences;</DELETED>
        <DELETED>    ``(3) promptly make available to the public data 
        developed in such research, demonstration projects, and 
        evaluations;</DELETED>
        <DELETED>    ``(4) provide, in collaboration with the National 
        Library of Medicine where appropriate, indexing, abstracting, 
        translating, publishing, and other services leading to a more 
        effective and timely dissemination of information on research, 
        demonstration projects, and evaluations with respect to 
        healthcare to public and private entities and individuals 
        engaged in the improvement of healthcare delivery and the 
        general public, and undertake programs to develop new or 
        improved methods for making such information available; 
        and</DELETED>
        <DELETED>    ``(5) as appropriate, provide technical assistance 
        to State and local government and health agencies and conduct 
        liaison activities to such agencies to foster 
        dissemination.</DELETED>
<DELETED>    ``(b) Prohibition Against Restrictions.--Except as 
provided in subsection (c), the Director may not restrict the 
publication or dissemination of data from, or the results of, projects 
conducted or supported under this title.</DELETED>
<DELETED>    ``(c) Limitation on Use of Certain Information.--No 
information, if an establishment or person supplying the information or 
described in it is identifiable, obtained in the course of activities 
undertaken or supported under this title may be used for any purpose 
other than the purpose for which it was supplied unless such 
establishment or person has consented (as determined under regulations 
of the Secretary) to its use for such other purpose. Such information 
may not be published or released in other form if the person who 
supplied the information or who is described in it is identifiable 
unless such person has consented (as determined under regulations of 
the Secretary) to its publication or release in other form.</DELETED>
<DELETED>    ``(d) Penalty.--Any person who violates subsection (c) 
shall be subject to a civil monetary penalty of not more than $10,000 
for each such violation involved. Such penalty shall be imposed and 
collected in the same manner as civil money penalties under subsection 
(a) of section 1128A of the Social Security Act are imposed and 
collected.</DELETED>

<DELETED>``SEC. 925. ADDITIONAL PROVISIONS WITH RESPECT TO GRANTS AND 
              CONTRACTS.</DELETED>

<DELETED>    ``(a) Financial Conflicts of Interest.--With respect to 
projects for which awards of grants, cooperative agreements, or 
contracts are authorized to be made under this title, the Director 
shall by regulation define--</DELETED>
        <DELETED>    ``(1) the specific circumstances that constitute 
        financial interests in such projects that will, or may be 
        reasonably expected to, create a bias in favor of obtaining 
        results in the projects that are consistent with such 
        interests; and</DELETED>
        <DELETED>    ``(2) the actions that will be taken by the 
        Director in response to any such interests identified by the 
        Director.</DELETED>
<DELETED>    ``(b) Requirement of Application.--The Director may not, 
with respect to any program under this title authorizing the provision 
of grants, cooperative agreements, or contracts, provide any such 
financial assistance unless an application for the assistance is 
submitted to the Secretary and the application is in such form, is made 
in such manner, and contains such agreements, assurances, and 
information as the Director determines to be necessary to carry out the 
program in involved.</DELETED>
<DELETED>    ``(c) Provision of Supplies and Services in Lieu of 
Funds.--</DELETED>
        <DELETED>    ``(1) In general.--Upon the request of an entity 
        receiving a grant, cooperative agreement, or contract under 
        this title, the Secretary may, subject to paragraph (2), 
        provide supplies, equipment, and services for the purpose of 
        aiding the entity in carrying out the project involved and, for 
        such purpose, may detail to the entity any officer or employee 
        of the Department of Health and Human Services.</DELETED>
        <DELETED>    ``(2) Corresponding reduction in funds.--With 
        respect to a request described in paragraph (1), the Secretary 
        shall reduce the amount of the financial assistance involved by 
        an amount equal to the costs of detailing personnel and the 
        fair market value of any supplies, equipment, or services 
        provided by the Director. The Secretary shall, for the payment 
        of expenses incurred in complying with such request, expend the 
        amounts withheld.</DELETED>
<DELETED>    ``(d) Applicability of Certain Provisions With Respect to 
Contracts.--Contracts may be entered into under this part without 
regard to sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 
529; 41 U.S.C. 5).</DELETED>

<DELETED>``SEC. 926. CERTAIN ADMINISTRATIVE AUTHORITIES.</DELETED>

<DELETED>    ``(a) Deputy Director and Other Officers and Employees.--
</DELETED>
        <DELETED>    ``(1) Deputy director.--The Director may appoint a 
        deputy director for the Agency.</DELETED>
        <DELETED>    ``(2) Other officers and employees.--The Director 
        may appoint and fix the compensation of such officers and 
        employees as may be necessary to carry out this title. Except 
        as otherwise provided by law, such officers and employees shall 
        be appointed in accordance with the civil service laws and 
        their compensation fixed in accordance with title 5, United 
        States Code.</DELETED>
<DELETED>    ``(b) Facilities.--The Secretary, in carrying out this 
title--</DELETED>
        <DELETED>    ``(1) may acquire, without regard to the Act of 
        March 3, 1877 (40 U.S.C. 34), by lease or otherwise through the 
        Director of General Services, buildings or portions of 
        buildings in the District of Columbia or communities located 
        adjacent to the District of Columbia for use for a period not 
        to exceed 10 years; and</DELETED>
        <DELETED>    ``(2) may acquire, construct, improve, repair, 
        operate, and maintain laboratory, research, and other necessary 
        facilities and equipment, and such other real or personal 
        property (including patents) as the Secretary deems 
        necessary.</DELETED>
<DELETED>    ``(c) Provision of Financial Assistance.--The Director, in 
carrying out this title, may make grants to public and nonprofit 
entities and individuals, and may enter into cooperative agreements or 
contracts with public and private entities and individuals.</DELETED>
<DELETED>    ``(d) Utilization of Certain Personnel and Resources.--
</DELETED>
        <DELETED>    ``(1) Department of health and human services.--
        The Director, in carrying out this title, may utilize personnel 
        and equipment, facilities, and other physical resources of the 
        Department of Health and Human Services, permit appropriate (as 
        determined by the Secretary) entities and individuals to 
utilize the physical resources of such Department, and provide 
technical assistance and advice.</DELETED>
        <DELETED>    ``(2) Other agencies.--The Director, in carrying 
        out this title, may use, with their consent, the services, 
        equipment, personnel, information, and facilities of other 
        Federal, State, or local public agencies, or of any foreign 
        government, with or without reimbursement of such 
        agencies.</DELETED>
<DELETED>    ``(e) Consultants.--The Secretary, in carrying out this 
title, may secure, from time to time and for such periods as the 
Director deems advisable but in accordance with section 3109 of title 
5, United States Code, the assistance and advice of consultants from 
the United States or abroad.</DELETED>
<DELETED>    ``(f) Experts.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary may, in carrying 
        out this title, obtain the services of not more than 50 experts 
        or consultants who have appropriate scientific or professional 
        qualifications. Such experts or consultants shall be obtained 
        in accordance with section 3109 of title 5, United States Code, 
        except that the limitation in such section on the duration of 
        service shall not apply.</DELETED>
        <DELETED>    ``(2) Travel expenses.--</DELETED>
                <DELETED>    ``(A) In general.--Experts and consultants 
                whose services are obtained under paragraph (1) shall 
                be paid or reimbursed for their expenses associated 
                with traveling to and from their assignment location in 
                accordance with sections 5724, 5724a(a), 5724a(c), and 
                5726(C) of title 5, United States Code.</DELETED>
                <DELETED>    ``(B) Limitation.--Expenses specified in 
                subparagraph (A) may not be allowed in connection with 
                the assignment of an expert or consultant whose 
                services are obtained under paragraph (1) unless and 
                until the expert agrees in writing to complete the 
                entire period of assignment, or 1 year, whichever is 
                shorter, unless separated or reassigned for reasons 
                that are beyond the control of the expert or consultant 
                and that are acceptable to the Secretary. If the expert 
                or consultant violates the agreement, the money spent 
                by the United States for the expenses specified in 
                subparagraph (A) is recoverable from the expert or 
                consultant as a statutory obligation owed to the United 
                States. The Secretary may waive in whole or in part a 
                right of recovery under this subparagraph.</DELETED>
<DELETED>    ``(g) Voluntary and Uncompensated Services.--The Director, 
in carrying out this title, may accept voluntary and uncompensated 
services.</DELETED>

<DELETED>``SEC. 927. FUNDING.</DELETED>

<DELETED>    ``(a) Intent.--To ensure that the United States's 
investment in biomedical research is rapidly translated into 
improvements in the quality of patient care, there must be a 
corresponding investment in research on the most effective clinical and 
organizational strategies for use of these findings in daily practice. 
The authorization levels in subsections (b) and (c) provide for a 
proportionate increase in healthcare research as the United State's 
investment in biomedical research increases.</DELETED>
<DELETED>    ``(b) Authorization of Appropriations.--For the purpose of 
carrying out this title, there are authorized to be appropriated 
$185,000,000 for fiscal year 2000, and such sums as may be necessary 
for each of the fiscal years 2001 through 2006.</DELETED>
<DELETED>    ``(c) Evaluations.--In addition to amounts available 
pursuant to subsection (b) for carrying out this title, there shall be 
made available for such purpose, from the amounts made available 
pursuant to section 241 (relating to evaluations), an amount equal to 
40 percent of the maximum amount authorized in such section 241 to be 
made available for a fiscal year.</DELETED>

<DELETED>``SEC. 929. DEFINITIONS.</DELETED>

<DELETED>    ``In this title:</DELETED>
        <DELETED>    ``(1) Advisory council.--The term `Advisory 
        Council' means the Advisory Council on Healthcare Research and 
        Quality established under section 921.</DELETED>
        <DELETED>    ``(2) Agency.--The term `Agency' means the Agency 
        for Healthcare Research and Quality.</DELETED>
        <DELETED>    ``(3) Director.--The term `Director' means the 
        Director for the Agency for Healthcare Research and 
        Quality.''.</DELETED>

<DELETED>SEC. 403. REFERENCES.</DELETED>

<DELETED>    Effective upon the date of enactment of this Act, any 
reference in law to the ``Agency for Health Care Policy and Research'' 
shall be deemed to be a reference to the ``Agency for Healthcare 
Research and Quality''.</DELETED>

<DELETED>SEC. 404. STUDY.</DELETED>

<DELETED>    (a) Study.--Not later than 30 days after the date of 
enactment of any Act providing for a qualifying health care benefit (as 
defined in subsection (b)), the Secretary of Health and Human Services, 
in consultation with the Agency for Healthcare Research and Quality, 
the National Institutes of Health, and the Institute of Medicine, shall 
conduct a study concerning such benefit that scientifically evaluates--
</DELETED>
        <DELETED>    (1) the safety and efficacy of the benefit, 
        particularly the effect of the benefit on outcomes of 
        care;</DELETED>
        <DELETED>    (2) the cost, benefits and value of such 
        benefit;</DELETED>
        <DELETED>    (3) the benefit in comparison to alternative 
        approaches in improving care; and</DELETED>
        <DELETED>    (4) the overall impact that such benefit will have 
        on health care as measured through research.</DELETED>
<DELETED>    (b) Qualifying Health Care Benefit.--In this section, the 
term ``qualifying health care benefit'' means a health care benefit 
that--</DELETED>
        <DELETED>    (1) is disease- or health condition-
        specific;</DELETED>
        <DELETED>    (2) requires the provision of or coverage for 
        health care items or services;</DELETED>
        <DELETED>    (3) applies to group health plan, individual 
        health plans, or health insurance issuers under part 7 of 
        subtitle B of title I of the Employee Retirement Income 
        Security Act of 1974 (29 U.S.C. 1181 et seq.) or under title 
        XXVII of the Public Health Service Act (42 U.S.C. 300gg et 
        seq.); and</DELETED>
        <DELETED>    (4) was provided under an Act (or amendment) 
        enacted on or after January 1, 1999.</DELETED>
<DELETED>    (c) Reports.--Not later than 3 years after the date of 
enactment of any Act described in subsection (a), the Secretary of 
Health and Human Services shall prepare and submit to the appropriate 
committees of Congress a report based on the study conducted under such 
subsection with respect to the qualifying health care benefit 
involved.</DELETED>

          <DELETED>TITLE V--MISCELLANEOUS PROVISIONS</DELETED>

<DELETED>SEC. 501. SENSE OF THE COMMITTEE.</DELETED>

<DELETED>    It is the sense of the Committee on Health, Education, 
Labor, and Pensions of the Senate that the Congress should take 
measures to further the purposes of this Act, including any necessary 
changes to the Internal Revenue Code of 1986 or to other Acts to--
</DELETED>
        <DELETED>    (1) promote equity and prohibit discrimination 
        based on genetic information with respect to the availability 
        of health benefits;</DELETED>
        <DELETED>    (2) provide for the full deduction of health 
        insurance costs for self-employed individuals;</DELETED>
        <DELETED>    (3) provide for the full availability of medical 
        savings accounts;</DELETED>
        <DELETED>    (4) provide for the carryover of unused benefits 
        from cafeteria plans, flexible spending arrangements, and 
        health flexible spending accounts; and</DELETED>
        <DELETED>    (5) permit contributions towards medical savings 
        account through the Federal employees health benefits 
        program.</DELETED>

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Patients' Bill of 
Rights Act''.
    (b) Table Of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.

                   TITLE I--PATIENTS' BILL OF RIGHTS

                  Subtitle A--Right to Advice and Care

Sec. 101.``subpart c--patient right to medical advice and care
        ``Sec. 721. Patient access to emergency medical care.
        ``Sec. 722. Offering of choice of coverage options.
        ``Sec. 723. Patient access to obstetric and gynecological care.
        ``Sec. 724. Patient access to pediatric care.
        ``Sec. 725. Access to specialists.
        ``Sec. 726. Continuity of care.
        ``Sec. 727. Protection of patient-provider communications.
        ``Sec. 728. Patient's right to prescription drugs.
        ``Sec. 729. Self-payment for behavioral health care services.
        ``Sec. 730. Generally applicable provision.
Sec. 102. Comprehensive independent study of patient access to clinical 
                            trials and coverage of associated routine 
                            costs.
Sec. 103. Effective date and related rules.

       Subtitle B--Right to Information About Plans and Providers

Sec. 111. Information about plans.
Sec. 112. Information about providers.

           Subtitle C--Right to Hold Health Plans Accountable

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

               TITLE II--GENETIC INFORMATION AND SERVICES

Sec. 201. Short title.
Sec. 202. Amendments to Employee Retirement Income Security Act of 
                            1974.
Sec. 203. Amendments to the Public Health Service Act.
Sec. 204. Amendments to the Internal Revenue Code of 1986.

               TITLE III--HEALTHCARE RESEARCH AND QUALITY

Sec. 301. Short title.
Sec. 302. Amendment to the Public Health Service Act.

         ``TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

               ``Part A--Establishment and General Duties

        ``Sec. 901. Mission and duties.
        ``Sec. 902. General authorities.

               ``Part B--Healthcare Improvement Research

        ``Sec. 911. Healthcare outcome improvement research.
        ``Sec. 912. Private-public partnerships to improve organization 
                            and delivery.
        ``Sec. 913. Information on quality and cost of care.
        ``Sec. 914. Information systems for healthcare improvement.
        ``Sec. 915. Research supporting primary care and access in 
                            underserved areas.
        ``Sec. 916. Clinical practice and technology innovation.
        ``Sec. 917. Coordination of Federal Government quality 
                            improvement efforts.

                      ``Part C--General Provisions

        ``Sec. 921. Advisory Council for Healthcare Research and 
                            Quality.
        ``Sec. 922. Peer review with respect to grants and contracts.
        ``Sec. 923. Certain provisions with respect to development, 
                            collection, and dissemination of data.
        ``Sec. 924. Dissemination of information.
        ``Sec. 925. Additional provisions with respect to grants and 
                            contracts.
        ``Sec. 926. Certain administrative authorities.
        ``Sec. 927. Funding.
        ``Sec. 928. Definitions.
Sec. 303. References.

                   TITLE IV--MISCELLANEOUS PROVISIONS

Sec. 401. Sense of the Committee.

                   TITLE I--PATIENTS' BILL OF RIGHTS

                  Subtitle A--Right to Advice and Care

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

    (a) In General.--Part 7 of subtitle B of title I of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 1181 et seq.) is 
amended--
            (1) by redesignating subpart C as subpart D; and
            (2) by inserting after subpart B the following:

         ``Subpart C--Patient Right to Medical Advice and Care

``SEC. 721. PATIENT ACCESS TO EMERGENCY MEDICAL CARE.

    ``(a) In General.--To the extent that the group health plan (other 
than a fully insured group health plan) provides coverage for benefits 
consisting of emergency medical care (as defined in subsection (c)), 
except for items or services specifically excluded--
            ``(1) the plan shall provide coverage for benefits, without 
        requiring preauthorization, for appropriate emergency medical 
        screening examinations (within the capability of the emergency 
        facility, including ancillary services routinely available to 
        the emergency facility) to the extent that a prudent layperson, 
        who possesses an average knowledge of health and medicine, 
        would determine such examinations to be necessary to determine 
        whether emergency medical care (as so defined) is necessary; 
        and
            ``(2) the plan shall provide coverage for benefits, without 
        requiring preauthorization, for additional emergency medical 
        care to stabilize an emergency medical condition following an 
        emergency medical screening examination (if determined 
        necessary under paragraph (1)), pursuant to the definition of 
        stabilize under section 1867(e)(3) of the Social Security Act 
        (42 U.S.C. 1395dd(e)(3)).
    ``(b) Uniform Cost-Sharing Required and Out-of-Network Care.--
            ``(1) Uniform cost-sharing.--Nothing in this section shall 
        be construed as preventing a group health plan (other than a 
        fully insured group health plan) from imposing any form of 
        cost-sharing applicable to any participant or beneficiary 
        (including coinsurance, copayments, deductibles, and any other 
        charges) in relation to coverage for benefits described in 
        subsection (a), if such form of cost-sharing is uniformly 
        applied under such plan, with respect to similarly situated 
        participants and beneficiaries, to all benefits consisting of 
        emergency medical care (as defined in subsection (c)) provided 
        to such similarly situated participants and beneficiaries under 
        the plan.
            ``(2) Out-of-network care.--If a group health plan (other 
        than a fully insured group health plan) provides any benefits 
        with respect to emergency medical care (as defined in 
        subsection (c)), the plan shall cover emergency medical care 
        under the plan in a manner so that, if such care is provided to 
        a participant or beneficiary by a nonparticipating health care 
        provider, the participant or beneficiary is not liable for 
        amounts that exceed the amounts of liability that would be 
        incurred if the services were provided by a participating 
        provider.
    ``(c) Definition of Emergency Medical Care.--In this section:
            ``(1) In general.--The term `emergency medical care' means, 
        with respect to a participant or beneficiary under a group 
        health plan (other than a fully insured group health plan), 
        covered inpatient and outpatient services that--
                    ``(A) are furnished by any provider, including a 
                nonparticipating provider, that is qualified to furnish 
                such services; and
                    ``(B) are needed to evaluate or stabilize (as such 
                term is defined in section 1867(e)(3) of the Social 
                Security Act (42 U.S.C. 1395dd)(e)(3)) an emergency 
                medical condition (as defined in paragraph (2)).
            ``(2) Emergency medical condition.--The term `emergency 
        medical condition' means a medical condition manifesting itself 
        by acute symptoms of sufficient severity (including severe 
        pain) such that a prudent layperson, who possesses an average 
        knowledge of health and medicine, could reasonably expect the 
        absence of immediate medical attention to result in--
                    ``(A) placing the health of the participant or 
                beneficiary (or, with respect to a pregnant woman, the 
                health of the woman or her unborn child) in serious 
                jeopardy,
                    ``(B) serious impairment to bodily functions, or
                    ``(C) serious dysfunction of any bodily organ or 
                part.

``SEC. 722. OFFERING OF CHOICE OF COVERAGE OPTIONS.

    ``(a) Requirement.--
            ``(1) Offering of point-of-service coverage option.--Except 
        as provided in paragraph (2), if a group health plan (other 
        than a fully insured group health plan) provides coverage for 
        benefits only through a defined set of participating health 
        care professionals, the plan shall offer the participant the 
        option to purchase point-of-service coverage (as defined in 
        subsection (b)) for all such benefits for which coverage is 
        otherwise so limited. Such option shall be made available to 
        the participant at the time of enrollment under the plan and at 
        such other times as the plan offers the participant a choice of 
        coverage options.
            ``(2) Exception in the case of multiple issuer or coverage 
        options.--Paragraph (1) shall not apply with respect to a 
        participant in a group health plan (other than a fully insured 
        group health plan) if the plan offers the participant 2 or more 
        coverage options that differ significantly with respect to the 
        use of participating health care professionals or the networks 
        of such professionals that are used.
    ``(b) Point-of-Service Coverage Defined.--In this section, the term 
`point-of-service coverage' means, with respect to benefits covered 
under a group health plan (other than a fully insured group health 
plan), coverage of such benefits when provided by a nonparticipating 
health care professional.
    ``(c) Small Employer Exemption.--
            ``(1) In general.--This section shall not apply to any 
        group health plan (other than a fully insured group health 
        plan) of a small employer.
            ``(2) Small employer.--For purposes of paragraph (1), the 
        term `small employer' means, in connection with a group health 
        plan (other than a fully insured group health plan) with 
        respect to a calendar year and a plan year, an employer who 
        employed an average of at least 2 but not more than 50 
        employees on business days during the preceding calendar year 
        and who employs at least 2 employees on the first day of the 
        plan year. For purposes of this paragraph, the provisions of 
subparagraph (C) of section 712(c)(1) shall apply in determining 
employer size.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed--
            ``(1) as requiring coverage for benefits for a particular 
        type of health care professional;
            ``(2) as requiring an employer to pay any costs as a result 
        of this section or to make equal contributions with respect to 
        different health coverage options;
            ``(3) as preventing a group health plan (other than a fully 
        insured group health plan) from imposing higher premiums or 
        cost-sharing on a participant for the exercise of a point-of-
        service coverage option; or
            ``(4) to require that a group health plan (other than a 
        fully insured group health plan) include coverage of health 
        care professionals that the plan excludes because of fraud, 
        quality of care, or other similar reasons with respect to such 
        professionals.

``SEC. 723. PATIENT ACCESS TO OBSTETRIC AND GYNECOLOGICAL CARE.

    ``(a) General Rights.--
            ``(1) Waiver of plan referral requirement.--If a group 
        health plan described in subsection (b) requires a referral to 
        obtain coverage for speciality care, the plan shall waive the 
        referral requirement in the case of a female participant or 
        beneficiary who seeks coverage for routine obstetrical care or 
        routine gynecological care.
            ``(2) Related routine care.--With respect to a participant 
        or beneficiary described in paragraph (1), a group health plan 
        described in subsection (b) shall treat the ordering of other 
        routine care that is related to routine obstetric or 
        gynecologic care, by a physician who specializes in obstetrics 
        and gynecology as the authorization of the primary care 
        provider for such other routine care.
    ``(b) Application of Section.--A group health plan described in 
this subsection is a group health plan (other than a fully insured 
group health plan), that--
            ``(1) provides coverage for routine obstetric care (such as 
        pregnancy-related services) or routine gynecologic care (such 
        as preventive women's health examinations); and
            ``(2) requires the designation by a participant or 
        beneficiary of a participating primary care provider who is not 
        a physician who specializes in obstetrics or gynecology.
    ``(c) Rules of Construction.--Nothing in this section shall be 
construed--
            ``(1) as waiving any coverage requirement relating to 
        medical necessity or appropriateness with respect to the 
        coverage of obstetric or gynecologic care described in 
        subsection (a);
            ``(2) to preclude the plan from requiring that the 
        physician who specializes in obstetrics or gynecology notify 
        the designated primary care provider or the plan of treatment 
        decisions; or
            ``(3) to preclude a group health plan from allowing health 
        care professionals other than physicians to provide routine 
        obstetric or routine gynecologic care.

``SEC. 724. PATIENT ACCESS TO PEDIATRIC CARE.

    ``(a) In General.--In the case of a group health plan (other than a 
fully insured group health plan) that provides coverage for routine 
pediatric care and that requires the designation by a participant or 
beneficiary of a participating primary care provider, if the designated 
primary care provider is not a physician who specializes in 
pediatrics--
            ``(1) the plan may not require authorization or referral by 
        the primary care provider in order for a participant or 
        beneficiary to obtain coverage for routine pediatric care; and
            ``(2) the plan shall treat the ordering of other routine 
        care related to routine pediatric care by such a specialist as 
        having been authorized by the designated primary care provider.
    ``(b) Rules of Construction.--Nothing in subsection (a) shall be 
construed--
            ``(1) as waiving any coverage requirement relating to 
        medical necessity or appropriateness with respect to the 
        coverage of any pediatric care provided to, or ordered for, a 
        participant or beneficiary;
            ``(2) to preclude a group health plan from requiring that a 
        specialist described in subsection (a) notify the designated 
        primary care provider or the plan of treatment decisions; or
            ``(3) to preclude a group health plan from allowing health 
        care professionals other than physicians to provide routine 
        pediatric care.

``SEC. 725. ACCESS TO SPECIALISTS.

    ``(a) In General.--A group health plan (other than a fully insured 
group health plan) shall ensure that participants and beneficiaries 
have access to specialty care when such care is covered under the plan. 
Such access may be provided through contractual arrangements with 
specialized providers outside of the network of the plan.
    ``(b) Treatment Plans.--
            ``(1) In general.--Nothing in this section shall be 
        construed to prohibit a group health plan (other than a fully 
        insured group health plan) from requiring that speciality care 
        be provided pursuant to a treatment plan so long as the 
        treatment plan is--
                    ``(A) developed by the specialist, in consultation 
                with the primary care provider, and the participant or 
                beneficiary;
                    ``(B) approved by the plan; and
                    ``(C) in accordance with the applicable quality 
                assurance and utilization review standards of the plan.
            ``(2) Notification.--Nothing in paragraph (1) shall be 
        construed as prohibiting a plan from requiring the specialist 
        to provide the primary care provider with regular updates on 
        the specialty care provided, as well as all other necessary 
        medical information.
    ``(c) Referrals.--Nothing in this section shall be construed to 
prohibit a plan from requiring an authorization by the primary care 
provider of the participant or beneficiary in order to obtain coverage 
for speciality services so long as such authorization is for an 
adequate number of referrals under an approved treatment plan if such a 
treatment plan is required by the plan.
    ``(d) Speciality Care Defined.--For purposes of this subsection, 
the term ``speciality care'' means, with respect to a condition, care 
and treatment provided by a health care practitioner, facility, or 
center (such as a center of excellence) that has adequate expertise 
(including age-appropriate expertise) through appropriate training and 
experience.

``SEC. 726. CONTINUITY OF CARE.

    ``(a) In General.--
            ``(1) Termination of provider.--If a contract between a 
        group health plan (other than a fully insured group health 
        plan) and a health care provider is terminated (as defined in 
        paragraph (2)), or benefits or coverage provided by a health 
        care provider are terminated because of a change in the terms 
        of provider participation in such group health plan, and an 
        individual who is a participant or beneficiary in the plan is 
        undergoing a course of treatment from the provider at the time 
        of such termination, the plan shall--
                    ``(A) notify the individual on a timely basis of 
                such termination;
                    ``(B) provide the individual with an opportunity to 
                notify the plan of a need for transitional care; and
                    ``(C) in the case of termination described in 
                paragraph (2), (3), or (4) of subsection (b), and 
                subject to subsection (c), permit the individual to 
                continue or be covered with respect to the course of 
                treatment with the provider's consent during a 
                transitional period (as provided under subsection (b)).
            ``(2) Terminated.--In this section, the term `terminated' 
        includes, with respect to a contract, the expiration or 
        nonrenewal of the contract by the group health plan, but does 
        not include a termination of the contract by the plan for 
        failure to meet applicable quality standards or for fraud.
            ``(3) Contracts.--For purposes of this section, the term 
        `contract between a group health plan (other than a fully 
        insured group health plan) and a health care provider' shall 
        include a contract between such a plan and an organized network 
        of providers.
    ``(b) Transitional Period.--
            ``(1) General rule.--Except as provided in paragraph (3), 
        the transitional period under this subsection shall permit the 
        participant or beneficiary to extend the coverage involved for 
        up to 90 days from the date of the notice described in 
        subsection (a)(1)(A) of the provider's termination.
            ``(2) Institutional care.--Subject to paragraph (1), the 
        transitional period under this subsection for institutional or 
        inpatient care from a provider shall extend until the discharge 
        or termination of the period of institutionalization and also 
        shall include institutional care provided within a reasonable 
        time of the date of termination of the provider status if the 
        care was scheduled before the date of the announcement of the 
        termination of the provider status under subsection (a)(1)(A) 
        or if the individual on such date was on an established waiting 
        list or otherwise scheduled to have such care.
            ``(3) Pregnancy.--Notwithstanding paragraph (1), if--
                    ``(A) a participant or beneficiary has entered the 
                second trimester of pregnancy at the time of a 
                provider's termination of participation; and
                    ``(B) the provider was treating the pregnancy 
                before the date of the termination;
        the transitional period under this subsection with respect to 
        provider's treatment of the pregnancy shall extend through the 
        provision of post-partum care directly related to the delivery.
            ``(4) Terminal illness.--Subject to paragraph (1), if--
                    ``(A) a participant or beneficiary was determined 
                to be terminally ill (as determined under section 
                1861(dd)(3)(A) of the Social Security Act) prior to a 
                provider's termination of participation; and
                    ``(B) the provider was treating the terminal 
                illness before the date of termination;
        the transitional period under this subsection shall be for care 
        directly related to the treatment of the terminal illness.
    ``(c) Permissible Terms and Conditions.--A group health plan (other 
than a fully insured group health plan) may condition coverage of 
continued treatment by a provider under subsection (a)(1)(C) upon the 
provider agreeing to the following terms and conditions:
            ``(1) The provider agrees to accept reimbursement from the 
        plan and individual involved (with respect to cost-sharing) at 
        the rates applicable prior to the start of the transitional 
        period as payment in full (or at the rates applicable under the 
        replacement plan after the date of the termination of the 
        contract with the group health plan) and not to impose cost-
        sharing with respect to the individual in an amount that would 
        exceed the cost-sharing that could have been imposed if the 
        contract referred to in subsection (a)(1) had not been 
        terminated.
            ``(2) The provider agrees to adhere to the quality 
        assurance standards of the plan responsible for payment under 
        paragraph (1) and to provide to such plan necessary medical 
        information related to the care provided.
            ``(3) The provider agrees otherwise to adhere to such 
        plan's policies and procedures, including procedures regarding 
        referrals and obtaining prior authorization and providing 
        services pursuant to a treatment plan (if any) approved by the 
        plan.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed to require the coverage of benefits which would not have been 
covered if the provider involved remained a participating provider.
    ``(e) Definition.--In this section, the term `health care provider' 
or `provider' means--
            ``(1) any individual who is engaged in the delivery of 
        health care services in a State and who is required by State 
        law or regulation to be licensed or certified by the State to 
        engage in the delivery of such services in the State; and
            ``(2) any entity that is engaged in the delivery of health 
        care services in a State and that, if it is required by State 
        law or regulation to be licensed or certified by the State to 
        engage in the delivery of such services in the State, is so 
        licensed.

``SEC. 727. PROTECTION OF PATIENT-PROVIDER COMMUNICATIONS.

    ``(a) In General.--Subject to subsection (b), a group health plan 
(other than a fully insured group health plan and in relation to a 
participant or beneficiary) shall not prohibit or otherwise restrict a 
health care professional from advising such a participant or 
beneficiary who is a patient of the professional about the health 
status of the participant or beneficiary or medical care or treatment 
for the condition or disease of the participant or beneficiary, 
regardless of whether coverage for such care or treatment are provided 
under the contract, if the professional is acting within the lawful 
scope of practice.
    ``(b) Rule of Construction.--Nothing in this section shall be 
construed as requiring a group health plan (other than a fully insured 
group health plan) to provide specific benefits under the terms of such 
plan.

``SEC. 728. PATIENT'S RIGHT TO PRESCRIPTION DRUGS.

    ``To the extent that a group health plan (other than a fully 
insured group health plan) provides coverage for benefits with respect 
to prescription drugs, and limits such coverage to drugs included in a 
formulary, the plan shall--
            ``(1) ensure the participation of physicians and 
        pharmacists in developing and reviewing such formulary; and
            ``(2) in accordance with the applicable quality assurance 
        and utilization review standards of the plan, provide for 
        exceptions from the formulary limitation when a non-formulary 
        alternative is medically necessary and appropriate.

``SEC. 729. SELF-PAYMENT FOR BEHAVIORAL HEALTH CARE SERVICES.

    ``(a) In General.--A group health plan (other than a fully insured 
group health plan) may not--
            ``(1) prohibit or otherwise discourage a participant or 
        beneficiary from self-paying for behavioral health care 
        services once the plan has denied coverage for such services; 
        or
            ``(2) terminate a health care provider because such 
        provider permits participants or beneficiaries to self-pay for 
        behavioral health care services--
                    ``(A) that are not otherwise covered under the 
                plan; or
                    ``(B) for which the group health plan provides 
                limited coverage, to the extent that the group health 
                plan denies coverage of the services.
    ``(b) Rule of Construction.--Nothing in subsection (a)(2)(B) shall 
be construed as prohibiting a group health plan from terminating a 
contract with a health care provider for failure to meet applicable 
quality standards or for fraud.

``SEC. 730. GENERALLY APPLICABLE PROVISION.

    ``In the case of a group health plan that provides benefits under 2 
or more coverage options, the requirements of this subpart, other than 
section 722, shall apply separately with respect to each coverage 
option.''.
    (b) Definition.--Section 733(a) of the Employee Retirement Income 
Security Act of 1974 (42 U.S.C. 1191(a)) is amended by adding at the 
end the following:
            ``(3) Fully insured group health plan.--The term `fully 
        insured group health plan' means a group health plan where 
        benefits under the plan are provided pursuant to the terms of 
        an arrangement between a group health plan and a health 
        insurance issuer and are guaranteed by the health insurance 
        issuer under a contract or policy of insurance.''.
    (c) Conforming Amendment.--The table of contents in section 1 of 
such Act is amended--
            (1) in the item relating to subpart C, by striking 
        ``Subpart C'' and inserting ``Subpart D''; and
            (2) by adding at the end of the items relating to subpart B 
        of part 7 of subtitle B of title I of such Act the following 
        new items:

         ``subpart c--patient right to medical advice and care
``Sec. 721. Patient access to emergency medical care.
``Sec. 722. Offering of choice of coverage options.
``Sec. 723. Patient access to obstetric and gynecological care.
``Sec. 724. Patient access to pediatric care.
``Sec. 725. Access to specialists.
``Sec. 726. Continuity of care.
``Sec. 727. Protection of patient-provider communications.
``Sec. 728. Patient's right to prescription drugs.
``Sec. 729. Self-payment for behavioral health care services.
``Sec. 730. Generally applicable provisions.''.

SEC. 102. COMPREHENSIVE INDEPENDENT STUDY OF PATIENT ACCESS TO CLINICAL 
              TRIALS AND COVERAGE OF ASSOCIATED ROUTINE COSTS.

    (a) Study by the Institute of Medicine.--Not later than 30 days 
after the date of enactment of this Act, the Secretary of Health and 
Human Services (in this section referred to as the ``Secretary'') shall 
enter into a contract with the Institute of Medicine to conduct a 
comprehensive study of patient access to clinical trials and the 
coverage of routine patient care costs by private health plans and 
insurers.
    (b) Matters To Be Assessed.--The study shall assess the following:
            (1) The factors that hinder patient participation in 
        clinical trials, including health plan and insurance policies 
        and practices.
            (2) The ability of health plans and investigators to 
        distinguish between routine patient care costs and costs 
        associated with clinical trials.
            (3) The potential impact of health plan coverage of routine 
        costs associated with clinical trials on health care premiums.
    (c) Report.--
            (1) In general.--Not later than 12 months after the date of 
        the execution of the contract referred to in subsection (a), 
        the Institute of Medicine shall submit a report on the study 
        conducted pursuant to that contract to the Committee on Health, 
        Education, Labor and Pensions of the Senate.
            (2) Matters included.--The report submitted under paragraph 
        (1) shall set forth the findings, conclusions, and 
        recommendations of the Institute of Medicine for--
                    (A) increasing patient participation in clinical 
                trials;
                    (B) encouraging collaboration between the public 
                and private sectors; and
                    (C) improving analysis of determining routine costs 
                associated with the conduct of clinical trials.
            (3) Copy to secretary.--Concurrent with the submission of 
        the report under paragraph (1), the Institute of Medicine shall 
        transmit a copy of the report to the Secretary.
    (d) Funding.--Out of funds appropriated to the Department of Health 
and Human Services for fiscal year 2000, the Secretary shall provide 
for such funding as the Secretary determines is necessary in order to 
carry out the study and report by the Institute of Medicine under this 
section.

SEC. 103. EFFECTIVE DATE AND RELATED RULES.

    (a) In General.--The amendments made by this subtitle shall apply 
with respect to plan years beginning on or after January 1 of the 
second calendar year following the date of the enactment of this Act. 
The Secretary shall issue all regulations necessary to carry out the 
amendments made by this section before the effective date thereof.
    (b) Limitation on Enforcement Actions.--No enforcement action shall 
be taken, pursuant to the amendments made by this subtitle, against a 
group health plan with respect to a violation of a requirement imposed 
by such amendments before the date of issuance of regulations issued in 
connection with such requirement, if the plan has sought to comply in 
good faith with such requirement.

       Subtitle B--Right to Information About Plans and Providers

SEC. 111. INFORMATION ABOUT PLANS.

    (a) Employee Retirement Income Security Act of 1974.--
            (1) In general.--Subpart B of part 7 of subtitle B of title 
        I of the Employee Retirement Income Security Act of 1974, as 
        amended by the Omnibus Consolidated and Emergency Supplemental 
        Appropriations Act, 1999 (Public Law 105-277), is amended by 
        adding at the end the following:

``SEC. 714. HEALTH PLAN COMPARATIVE INFORMATION.

    ``(a) Requirement.--
            ``(1) In general.--A group health plan, and a health 
        insurance issuer that provides coverage in connection with 
        group health insurance coverage, shall, not later than 12 
        months after the date of enactment of this section, and at 
        least annually thereafter, provide for the disclosure, in a 
        clear and accurate form to each participant and each 
        beneficiary who does not reside at the same address as the 
        participant, or upon request to an individual eligible for 
        coverage under the plan, of the information described in 
        subsection (b).
            ``(2) Rule of construction.--Nothing in this section shall 
        be construed to prevent a plan or issuer from entering into any 
        agreement under which the issuer agrees to assume 
        responsibility for compliance with the requirements of this 
        section and the plan is released from liability for such 
        compliance.
            ``(3) Provision of information.--Information shall be 
        provided to participants and beneficiaries under this section 
        at the address maintained by the plan or issuer with respect to 
        such participants or beneficiaries.
    ``(b) Required Information.--The informational materials to be 
distributed under this section shall include for each package option 
available under a group health plan the following:
            ``(1) A description of the covered items and services under 
        each such plan and any in- and out-of-network features of each 
        such plan, including a summary description of the specific 
        exclusions from coverage under the plan.
            ``(2) A description of any cost-sharing, including 
        premiums, deductibles, coinsurance, and copayment amounts, for 
        which the participant or beneficiary will be responsible, 
        including any annual or lifetime limits on benefits, for each 
        such plan.
            ``(3) A description of any optional supplemental benefits 
        offered by each such plan and the terms and conditions 
        (including premiums or cost-sharing) for such supplemental 
        coverage.
            ``(4) A description of any restrictions on payments for 
        services furnished to a participant or beneficiary by a health 
        care professional that is not a participating professional and 
        the liability of the participant or beneficiary for additional 
        payments for these services.
            ``(5) A description of the service area of each such plan, 
        including the provision of any out-of-area coverage.
            ``(6) A description of the extent to which participants and 
        beneficiaries may select the primary care provider of their 
        choice, including providers both within the network and outside 
        the network of each such plan (if the plan permits out-of-
        network services).
            ``(7) A description of the procedures for advance 
        directives and organ donation decisions if the plan maintains 
        such procedures.
            ``(8) A description of the requirements and procedures to 
        be used to obtain preauthorization for health services 
        (including telephone numbers and mailing addresses), including 
        referrals for specialty care.
            ``(9) A description of the definition of medical necessity 
        used in making coverage determinations by each such plan.
            ``(10) A summary of the rules and methods for appealing 
        coverage decisions and filing grievances (including telephone 
        numbers and mailing addresses), as well as other available 
        remedies.
            ``(11) A summary description of any provisions for 
        obtaining off-formulary medications if the plan utilizes a 
        defined formulary for providing specific prescription 
        medications.
            ``(12) A summary of the rules for access to emergency room 
        care. Also, any available educational material regarding proper 
        use of emergency services.
            ``(13) A description of whether or not coverage is provided 
        for experimental treatments, investigational treatments, or 
        clinical trials and the circumstances under which access to 
        such treatments or trials is made available.
            ``(14) A description of the specific preventative services 
        covered under the plan if such services are covered.
            ``(15) A statement regarding--
                    ``(A) the manner in which a participant or 
                beneficiary may access an obstetrician, gynecologist, 
                or pediatrician in accordance with section 723 or 724; 
                and
                    ``(B) the manner in which a participant or 
                beneficiary obtains continuity of care as provided for 
                in section 726.
            ``(16) A statement that the following information, and 
        instructions on obtaining such information (including telephone 
        numbers and, if available, Internet websites), shall be made 
        available upon request:
                    ``(A) The names, addresses, telephone numbers, and 
                State licensure status of the plan's participating 
                health care professionals and participating health care 
                facilities, and, if available, the education, training, 
                speciality qualifications or certifications of such 
                professionals.
                    ``(B) A summary description of the methods used for 
                compensating participating health care professionals, 
                such as capitation, fee-for-service, salary, or a 
                combination thereof. The requirement of this 
                subparagraph shall not be construed as requiring plans 
                to provide information concerning proprietary payment 
                methodology.
                    ``(C) A summary description of the methods used for 
                compensating health care facilities, including per 
                diem, fee-for-service, capitation, bundled payments, or 
                a combination thereof. The requirement of this 
                subparagraph shall not be construed as requiring plans 
                to provide information concerning proprietary payment 
                methodology.
                    ``(D) A summary description of the procedures used 
                for utilization review.
                    ``(E) The list of the specific prescription 
                medications included in the formulary of the plan, if 
                the plan uses a defined formulary.
                    ``(F) A description of the specific exclusions from 
                coverage under the plan.
                    ``(G) Any available information related to the 
                availability of translation or interpretation services 
                for non-English speakers and people with communication 
                disabilities, including the availability of audio tapes 
                or information in Braille.
                    ``(H) Any information that is made public by 
                accrediting organizations in the process of 
                accreditation if the plan is accredited, or any 
                additional quality indicators that the plan makes 
                available.
    ``(c) Manner of Distribution.--The information described in this 
section shall be distributed in an accessible format that is 
understandable to an average plan participant or beneficiary.
    ``(d) Rule of Construction.--Nothing in this section may be 
construed to prohibit a group health plan, or health insurance issuer 
in connection with group health insurance coverage, from distributing 
any other additional information determined by the plan or issuer to be 
important or necessary in assisting participants and beneficiaries or 
upon request potential participants and beneficiaries in the selection 
of a health plan or from providing information under subsection (b)(15) 
as part of the required information.
    ``(e) Conforming Regulations.--The Secretary shall issue 
regulations to coordinate the requirements on group health plans and 
health insurance issuers under this section with the requirements 
imposed under part 1, to reduce duplication with respect to any 
information that is required to be provided under any such 
requirements.
    ``(f) Health Care Professional.--In this section, the term `health 
care professional' means a physician (as defined in section 1861(r) of 
the Social Security Act) or other health care professional if coverage 
for the professional's services is provided under the health plan 
involved for the services of the professional. Such term includes a 
podiatrist, optometrist, chiropractor, psychologist, dentist, physician 
assistant, physical or occupational therapist and therapy assistant, 
speech-language pathologist, audiologist, registered or licensed 
practical nurse (including nurse practitioner, clinical nurse 
specialist, certified registered nurse anesthetist, and certified 
nurse-midwife), licensed certified social worker, registered 
respiratory therapist, and certified respiratory therapy technician.''.
            (2) Conforming amendments.--
                    (A) Section 732(a) of the Employee Retirement 
                Income Security Act of 1974 (29 U.S.C. 1191a(a)) is 
                amended by striking ``section 711, and inserting 
                ``sections 711 and 714''.
                    (B) The table of contents in section 1 of the 
                Employee Retirement Income Security Act of 1974 (29 
                U.S.C. 1001) is amended by inserting after the item 
                relating to section 713, the following:

        ``Sec. 714. Health plan comparative information.''.
    (b) Internal Revenue Code of 1986.--Subchapter B of chapter 100 of 
the Internal Revenue Code of 1986 is amended--
            (1) in the table of sections, by inserting after the item 
        relating to section 9812 the following new item:

                              ``Sec. 9813. Health plan comparative 
                                        information.''; and
            (2) by inserting after section 9812 the following:

``SEC. 9813. HEALTH PLAN COMPARATIVE INFORMATION.

    ``(a) Requirement.--
            ``(1) In general.--A group health plan shall, not later 
        than 12 months after the date of enactment of this section, and 
        at least annually thereafter, provide for the disclosure, in a 
        clear and accurate form to each participant and each 
        beneficiary who does not reside at the same address as the 
        participant, or upon request to an individual eligible for 
        coverage under the plan, of the information described in 
        subsection (b).
            ``(2) Rules of construction.--Nothing in this section shall 
        be construed to prevent a plan from entering into any agreement 
        under which a health insurance issuer agrees to assume 
        responsibility for compliance with the requirements of this 
        section and the plan is released from liability for such 
        compliance.
            ``(3) Provision of information.--Information shall be 
        provided to participants and beneficiaries under this section 
        at the address maintained by the plan with respect to such 
        participants or beneficiaries.
    ``(b) Required Information.--The informational materials to be 
distributed under this section shall include for each package option 
available under a group health plan the following:
            ``(1) A description of the covered items and services under 
        each such plan and any in- and out-of-network features of each 
        such plan, including a summary description of the specific 
        exclusions from coverage under the plan.
            ``(2) A description of any cost-sharing, including 
        premiums, deductibles, coinsurance, and copayment amounts, for 
        which the participant or beneficiary will be responsible, 
        including any annual or lifetime limits on benefits, for each 
        such plan.
            ``(3) A description of any optional supplemental benefits 
        offered by each such plan and the terms and conditions 
        (including premiums or cost-sharing) for such supplemental 
        coverage.
            ``(4) A description of any restrictions on payments for 
        services furnished to a participant or beneficiary by a health 
        care professional that is not a participating professional and 
        the liability of the participant or beneficiary for additional 
        payments for these services.
            ``(5) A description of the service area of each such plan, 
        including the provision of any out-of-area coverage.
            ``(6) A description of the extent to which participants and 
        beneficiaries may select the primary care provider of their 
        choice, including providers both within the network and outside 
        the network of each such plan (if the plan permits out-of-
        network services).
            ``(7) A description of the procedures for advance 
        directives and organ donation decisions if the plan maintains 
        such procedures.
            ``(8) A description of the requirements and procedures to 
        be used to obtain preauthorization for health services 
        (including telephone numbers and mailing addresses), including 
        referrals for specialty care.
            ``(9) A description of the definition of medical necessity 
        used in making coverage determinations by each such plan.
            ``(10) A summary of the rules and methods for appealing 
        coverage decisions and filing grievances (including telephone 
        numbers and mailing addresses), as well as other available 
        remedies.
            ``(11) A summary description of any provisions for 
        obtaining off-formulary medications if the plan utilizes a 
        defined formulary for providing specific prescription 
        medications.
            ``(12) A summary of the rules for access to emergency room 
        care. Also, any available educational material regarding proper 
        use of emergency services.
            ``(13) A description of whether or not coverage is provided 
        for experimental treatments, investigational treatments, or 
        clinical trials and the circumstances under which access to 
        such treatments or trials is made available.
            ``(14) A description of the specific preventative services 
        covered under the plan if such services are covered.
            ``(15) A statement regarding--
                    ``(A) the manner in which a participant or 
                beneficiary may access an obstetrician, gynecologist, 
                or pediatrician in accordance with section 723 or 724; 
                and
                    ``(B) the manner in which a participant or 
                beneficiary obtains continuity of care as provided for 
                in section 726.
            ``(16) A statement that the following information, and 
        instructions on obtaining such information (including telephone 
        numbers and, if available, Internet websites), shall be made 
        available upon request:
                    ``(A) The names, addresses, telephone numbers, and 
                State licensure status of the plan's participating 
                health care professionals and participating health care 
                facilities, and, if available, the education, training, 
                speciality qualifications or certifications of such 
                professionals.
                    ``(B) A summary description of the methods used for 
                compensating participating health care professionals, 
                such as capitation, fee-for-service, salary, or a 
                combination thereof. The requirement of this 
                subparagraph shall not be construed as requiring plans 
                to provide information concerning proprietary payment 
                methodology.
                    ``(C) A summary description of the methods used for 
                compensating health care facilities, including per 
                diem, fee-for-service, capitation, bundled payments, or 
                a combination thereof. The requirement of this 
                subparagraph shall not be construed as requiring plans 
                to provide information concerning proprietary payment 
                methodology.
                    ``(D) A summary description of the procedures used 
                for utilization review.
                    ``(E) The list of the specific prescription 
                medications included in the formulary of the plan, if 
                the plan uses a defined formulary.
                    ``(F) A description of the specific exclusions from 
                coverage under the plan.
                    ``(G) Any available information related to the 
                availability of translation or interpretation services 
                for non-English speakers and people with communication 
                disabilities, including the availability of audio tapes 
                or information in Braille.
                    ``(H) Any information that is made public by 
                accrediting organizations in the process of 
                accreditation if the plan is accredited, or any 
                additional quality indicators that the plan makes 
                available.
    ``(c) Manner of Distribution.--The information described in this 
section shall be distributed in an accessible format that is 
understandable to an average plan participant or beneficiary.
    ``(d) Rule of Construction.--Nothing in this section may be 
construed to prohibit a group health plan from distributing any other 
additional information determined by the plan to be important or 
necessary in assisting participants and beneficiaries or upon request 
potential participants and beneficiaries in the selection of a health 
plan or from providing information under subsection (b)(15) as part of 
the required information.
    ``(e) Health Care Professional.--In this section, the term `health 
care professional' means a physician (as defined in section 1861(r) of 
the Social Security Act) or other health care professional if coverage 
for the professional's services is provided under the health plan 
involved for the services of the professional. Such term includes a 
podiatrist, optometrist, chiropractor, psychologist, dentist, physician 
assistant, physical or occupational therapist and therapy assistant, 
speech-language pathologist, audiologist, registered or licensed 
practical nurse (including nurse practitioner, clinical nurse 
specialist, certified registered nurse anesthetist, and certified 
nurse-midwife), licensed certified social worker, registered 
respiratory therapist, and certified respiratory therapy technician.''.

SEC. 112. INFORMATION ABOUT PROVIDERS.

    (a) Study.--The Secretary of Health and Human Services shall enter 
into a contract with the Institute of Medicine for the conduct of a 
study, and the submission to the Secretary of a report, that includes--
            (1) an analysis of information concerning health care 
        professionals that is currently available to patients, 
        consumers, States, and professional societies, nationally and 
        on a State-by-State basis, including patient preferences with 
        respect to information about such professionals and their 
        competencies;
            (2) an evaluation of the legal and other barriers to the 
        sharing of information concerning health care professionals; 
        and
            (3) recommendations for the disclosure of information on 
        health care professionals, including the competencies and 
        professional qualifications of such practitioners, to better 
        facilitate patient choice, quality improvement, and market 
        competition.
    (b) Report.--Not later than 18 months after the date of enactment 
of this Act, the Secretary of Health and Human Services shall forward 
to the appropriate committees of Congress a copy of the report and 
study conducted under subsection (a).

           Subtitle C--Right to Hold Health Plans Accountable

SEC. 121. AMENDMENT TO EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974.

    (a) In General.--Section 503 of the Employee Retirement Income 
Security Act of 1974 (29 U.S.C. 1133) is amended to read as follows:

``SEC. 503. CLAIMS PROCEDURE, COVERAGE DETERMINATION, GRIEVANCES AND 
              APPEALS.

    ``(a) Claims Procedure.--In accordance with regulations of the 
Secretary, every employee benefit plan shall--
            ``(1) provide adequate notice in writing to any participant 
        or beneficiary whose claim for benefits under the plan has been 
        denied, setting forth the specific reasons for such denial, 
        written in a manner calculated to be understood by the 
        participant; and
            ``(2) afford a reasonable opportunity to any participant 
        whose claim for benefits has been denied for a full and fair 
        review by the appropriate named fiduciary of the decision 
        denying the claim.
    ``(b) Coverage Determinations Under Group Health Plans.--
            ``(1) Procedures.--
                    ``(A) In general.--A group health plan or health 
                insurance issuer conducting utilization review shall 
                ensure that procedures are in place for--
                            ``(i) making determinations regarding 
                        whether a participant or beneficiary is 
                        eligible to receive a payment or coverage for 
                        health services under the plan or coverage 
                        involved and any cost-sharing amount that the 
                        participant or beneficiary is required to pay 
                        with respect to such service;
                            ``(ii) notifying a covered participant or 
                        beneficiary (or the authorized representative 
                        of such participant or beneficiary) and the 
                        treating health care professionals involved 
                        regarding determinations made under the plan or 
                        issuer and any additional payments that the 
                        participant or beneficiary may be required to 
                        make with respect to such service; and
                            ``(iii) responding to requests, either 
                        written or oral, for coverage determinations or 
                        for internal appeals from a participant or 
                        beneficiary (or the authorized representative 
                        of such participant or beneficiary) or the 
                        treating health care professional with the 
                        consent of the participant or beneficiary.
                    ``(B) Oral requests.--With respect to an oral 
                request described in subparagraph (A)(iii), a group 
                health plan or health insurance issuer may require that 
                the requesting individual provide written evidence of 
                such request.
            ``(2) Timeline for making determinations.--
                    ``(A) Routine determination.--A group health plan 
                or a health insurance issuer shall maintain procedures 
                to ensure that prior authorization determinations 
                concerning the provision of non-emergency items or 
                services are made within 30 days from the date on which 
                the request for a determination is submitted, except 
                that such period may be extended where certain 
                circumstances exist that are determined by the 
                Secretary to be beyond control of the plan or issuer.
                    ``(B) Expedited determination.--
                            ``(i) In general.--A prior authorization 
                        determination under this subsection shall be 
                        made within 72 hours, in accordance with the 
                        medical exigencies of the case, after a request 
                        is received by the plan or issuer under clause 
                        (ii) or (iii).
                            ``(ii) Request by participant or 
                        beneficiary.--A plan or issuer shall maintain 
                        procedures for expediting a prior authorization 
                        determination under this subsection upon the 
                        request of a participant or beneficiary if, 
                        based on such a request, the plan or issuer 
                        determines that the normal time for making such 
                        a determination could seriously jeopardize the 
                        life or health of the participant or 
                        beneficiary.
                            ``(iii) Documentation by health care 
                        professional.--A plan or issuer shall maintain 
                        procedures for expediting a prior authorization 
                        determination under this subsection if the 
                        request involved indicates that the treating 
                        health care professional has reasonably 
                        documented, based on the medical exigencies, 
                        that a determination under the procedures 
                        described in subparagraph (A) could seriously 
                        jeopardize the life or health of the 
                        participant or beneficiary.
                    ``(C) Concurrent determinations.--A plan or issuer 
                shall maintain procedures to certify or deny coverage 
                of an extended stay or additional services.
                    ``(D) Retrospective determination.--A plan or 
                issuer shall maintain procedures to ensure that, with 
                respect to the retrospective review of a determination 
                made under paragraph (1), the determination shall be 
                made within 30 working days of the date on which the 
                plan or issuer receives necessary information.
            ``(3) Notice of determinations.--
                    ``(A) Routine determination.--With respect to a 
                coverage determination of a plan or issuer under 
                paragraph (2)(A), the plan or issuer shall issue notice 
                of such determination to the participant or beneficiary 
                (or the authorized representative of the participant or 
                beneficiary) and, consistent with the medical 
                exigencies of the case, to the treating health care 
                professional involved not later than 2 working days 
                after the date on which the determination is made.
                    ``(B) Expedited determination.--With respect to a 
                coverage determination of a plan or issuer under 
                paragraph (2)(B), the plan or issuer shall issue notice 
                of such determination to the participant or beneficiary 
                (or the authorized representative of the participant or 
                beneficiary), and consistent with the medical 
                exigencies of the case, to the treating health care 
                professional involved within the 72 hour period 
                described in paragraph (2)(B).
                    ``(C) Concurrent reviews.--With respect to the 
                determination under a plan or issuer under paragraph 
                (2)(C) to certify or deny coverage of an extended stay 
                or additional services, the plan or issuer shall issue 
                notice of such determination to the treating health 
                care professional and to the participant or beneficiary 
                involved (or the authorized representative of the 
                participant or beneficiary) within 1 working day of the 
                determination.
                    ``(D) Retrospective reviews.--With respect to the 
                retrospective review under a plan or issuer of a 
                determination made under paragraph (2)(D), the plan or 
                issuer shall issue written notice of an approval or 
                disapproval of a determination under this subparagraph 
                to the participant or beneficiary (or the authorized 
                representative of the participant or beneficiary) and 
                health care provider involved within 5 working days of 
                the date on which such determination is made.
                    ``(E) Requirements of notice of adverse coverage 
                determinations.--A written notice of an adverse 
                coverage determination under this subsection, or of an 
                expedited adverse coverage determination under 
                paragraph (2)(B), shall be provided to the participant 
                or beneficiary (or the authorized representative of the 
                participant or beneficiary) and treating health care 
                professional (if any) involved and shall include--
                            ``(i) the reasons for the determination 
                        (including the clinical or scientific-evidence 
                        based rationale used in making the 
                        determination) written in a manner to be 
                        understandable to the average participant or 
                        beneficiary;
                            ``(ii) the procedures for obtaining 
                        additional information concerning the 
                        determination; and
                            ``(iii) notification of the right to appeal 
                        the determination and instructions on how to 
                        initiate an appeal in accordance with 
                        subsection (d).
    ``(c) Grievances.--A group health plan or a health insurance issuer 
shall have written procedures for addressing grievances between the 
plan or issuer offering health insurance coverage in connection with a 
group health plan and a participant or beneficiary. Determinations 
under such procedures shall be non-appealable.
    ``(d) Internal Appeal of Coverage Determinations.--
            ``(1) Right to appeal.--
                    ``(A) In general.--A participant or beneficiary (or 
                the authorized representative of the participant or 
                beneficiary) or the treating health care professional 
                with the consent of the participant or beneficiary (or 
                the authorized representative of the participant or 
                beneficiary), may appeal any adverse coverage 
                determination under subsection (b) under the procedures 
                described in this subsection.
                    ``(B) Time for appeal.--A plan or issuer shall 
                ensure that a participant or beneficiary has a period 
                of not less than 180 days beginning on the date of an 
                adverse coverage determination under subsection (b) in 
                which to appeal such determination under this 
                subsection.
                    ``(C) Failure to act.--The failure of a plan or 
                issuer to issue a determination under subsection (b) 
                within the applicable timeline established for such a 
                determination under such subsection shall be treated as 
                an adverse coverage determination for purposes of 
                proceeding to internal review under this subsection.
            ``(2) Records.--A group health plan and a health insurance 
        issuer shall maintain written records, for at least 6 years, 
        with respect to any appeal under this subsection for purposes 
        of internal quality assurance and improvement. Nothing in the 
        preceding sentence shall be construed as preventing a plan and 
        issuer from entering into an agreement under which the issuer 
        agrees to assume responsibility for compliance with the 
        requirements of this section and the plan is released from 
        liability for such compliance.
            ``(3) Routine determinations.--A group health plan or a 
        health insurance issuer shall complete the consideration of an 
        appeal of an adverse routine determination under this 
        subsection not later than 30 working days after the date on 
which a request for such appeal is received.
            ``(4) Expedited determination.--
                    ``(A) In general.--An expedited determination with 
                respect to an appeal under this subsection shall be 
                made in accordance with the medical exigencies of the 
                case, but in no case more than 72 hours after the 
                request for such appeal is received by the plan or 
                issuer under subparagraph (B) or (C).
                    ``(B) Request by participant or beneficiary.--A 
                plan or issuer shall maintain procedures for expediting 
                a prior authorization determination under this 
                subsection upon the request of a participant or 
                beneficiary if, based on such a request, the plan or 
                issuer determines that the normal time for making such 
                a determination could seriously jeopardize the life or 
                health of the participant or beneficiary.
                    ``(C) Documentation by health care professional.--A 
                plan or issuer shall maintain procedures for expediting 
                a prior authorization determination under this 
                subsection if the request involved indicates that the 
                treating health care professional has reasonably 
                documented, based on the medical exigencies of the case 
                that a determination under the procedures described in 
                paragraph (2) could seriously jeopardize the life or 
                health of the participant or beneficiary.
            ``(5) Conduct of review.--A review of an adverse coverage 
        determination under this subsection shall be conducted by an 
        individual with appropriate expertise who was not directly 
        involved in the initial determination.
            ``(6) Lack of medical necessity.--A review of an appeal 
        under this subsection relating to a determination to deny 
        coverage based on a lack of medical necessity and 
        appropriateness, or based on an experimental or investigational 
        treatment, shall be made only by a physician with appropriate 
        expertise, including age-appropriate expertise, who was not 
        involved in the initial determination.
            ``(7) Notice.--
                    ``(A) In general.--Written notice of a 
                determination made under an internal review process 
                shall be issued to the participant or beneficiary (or 
                the authorized representative of the participant or 
                beneficiary) and the treating health care professional 
                not later than 2 working days after the completion of 
                the review (or within the 72-hour period referred to in 
                paragraph (4) if applicable).
                    ``(B) Adverse coverage determinations.--With 
                respect to an adverse coverage determination made under 
                this subsection, the notice described in subparagraph 
                (A) shall include--
                            ``(i) the reasons for the determination 
                        (including the clinical or scientific-evidence 
                        based rationale used in making the 
                        determination) written in a manner to be 
                        understandable to the average participant or 
                        beneficiary;
                            ``(ii) the procedures for obtaining 
                        additional information concerning the 
                        determination; and
                            ``(iii) notification of the right to an 
                        independent external review under subsection 
                        (e) and instructions on how to initiate such a 
                        review.
    ``(e) Independent External Review.--
            ``(1) Access to review.--
                    ``(A) In general.--A group health plan or a health 
                insurance issuer offering health insurance coverage in 
                connection with a group health plan shall have written 
                procedures to permit a participant or beneficiary (or 
                the authorized representative of the participant or 
                beneficiary) access to an independent external review 
                with respect to an adverse coverage determination 
                concerning a particular item or service (including a 
                circumstance treated as an adverse coverage 
                determination under subparagraph (B)) where--
                            ``(i) the particular item or service 
                        involved--
                                    ``(I)(aa) would be a covered 
                                benefit, when medically necessary and 
                                appropriate under the terms and 
                                conditions of the plan, and the item or 
                                service has been determined not to be 
                                medically necessary and appropriate 
                                under the internal appeals process 
                                required under subsection (d) or there 
                                has been a failure to issue a coverage 
                                determination as described in 
                                subparagraph (B); and
                                    ``(bb)(AA) the amount of such item 
                                or service involved exceeds a 
                                significant financial threshold; or
                                    ``(BB) there is a significant risk 
                                of placing the life or health of the 
                                participant or beneficiary in jeopardy; 
                                or
                                    ``(II) would be a covered benefit, 
                                when not considered experimental or 
                                investigational under the terms and 
                                conditions of the plan, and the item or 
                                service has been determined to be 
                                experimental or investigational under 
                                the internal appeals process required 
                                under subsection (d) or there has been 
                                a failure to issue a coverage 
                                determination as described in 
                                subparagraph (B); and
                            ``(ii) the participant or beneficiary has 
                        completed the internal appeals process under 
                        subsection (d) with respect to such 
                        determination.
                    ``(B) Failure to act.--The failure of a plan or 
                issuer to issue a coverage determination under 
                subsection (d)(6) within the applicable timeline 
                established for such a determination under such 
                subsection shall be treated as an adverse coverage 
                determination for purposes of proceeding to independent 
                external review under this subsection.
            ``(2) Initiation of the independent external review 
        process.--
                    ``(A) Filing of request.--A participant or 
                beneficiary (or the authorized representative of the 
                participant or beneficiary) who desires to have an 
                independent external review conducted under this 
                subsection shall file a written request for such a 
                review with the plan or issuer involved not later than 
                30 working days after the receipt of a final denial of 
                a claim under subsection (d). Any such request shall 
                include the consent of the participant or beneficiary 
                (or the authorized representative of the participant or 
                beneficiary) for the release of medical information and 
                records to independent external reviewers regarding the 
                participant or beneficiary.
                    ``(B) Information and notice.--Not later than 5 
                working days after the receipt of a request under 
                subparagraph (A), or earlier in accordance with the 
                medical exigencies of the case, the plan or issuer 
                involved shall select an external appeals entity under 
                paragraph (3)(A) that shall be responsible for 
                designating an independent external reviewer under 
                paragraph (3)(B).
                    ``(C) Provision of information.--The plan or issuer 
                involved shall forward necessary information (including 
                medical records, any relevant review criteria, the 
                clinical rationale consistent with the terms and 
                conditions of the contract between the plan or issuer 
                and the participant or beneficiary for the coverage 
                denial, and evidence of the coverage of the participant 
                or beneficiary) to the independent external reviewer 
                selected under paragraph (3)(B).
                    ``(D) Notification.--The plan or issuer involved 
                shall send a written notification to the participant or 
                beneficiary (or the authorized representative of the 
                participant or beneficiary) and the plan administrator, 
                indicating that an independent external review has been 
                initiated.
            ``(3) Conduct of independent external review.--
                    ``(A) Designation of external appeals entity by 
                plan or issuer.--
                            ``(i) In general.--A plan or issuer that 
                        receives a request for an independent external 
                        review under paragraph (2)(A) shall designate a 
                        qualified entity described in clause (ii), in a 
                        manner designed to ensure that the entity so 
                        designated will make a decision in an unbiased 
                        manner, to serve as the external appeals 
                        entity.
                            ``(ii) Qualified entities.--A qualified 
                        entity shall be--
                                    ``(I) an independent external 
                                review entity licensed or credentialed 
                                by a State;
                                    ``(II) a State agency established 
                                for the purpose of conducting 
                                independent external reviews;
                                    ``(III) any entity under contract 
                                with the Federal Government to provide 
                                independent external review services;
                                    ``(IV) any entity accredited as an 
                                independent external review entity by 
                                an accrediting body recognized by the 
                                Secretary for such purpose; or
                                    ``(V) any other entity meeting 
                                criteria established by the Secretary 
                                for purposes of this subparagraph.
                    ``(B) Designation of independent external reviewer 
                by external appeals entity.--The external appeals 
                entity designated under subparagraph (A) shall, not 
                later than 30 days after the date on which such entity 
                is designated under subparagraph (A), or earlier in 
                accordance with the medical exigencies of the case, 
                designate one or more individuals to serve as 
                independent external reviewers with respect to a 
                request received under paragraph (2)(A). Such reviewers 
                shall be independent medical experts who shall--
                            ``(i) be appropriately credentialed or 
                        licensed in any State to deliver health care 
                        services;
                            ``(ii) not have any material, professional, 
                        familial, or financial affiliation with the 
                        case under review, the participant or 
                        beneficiary involved, the treating health care 
                        professional, the institution where the 
                        treatment would take place, or the manufacturer 
of any drug, device, procedure, or other therapy proposed for the 
participant or beneficiary whose treatment is under review;
                            ``(iii) have expertise (including age-
                        appropriate expertise) in the diagnosis or 
                        treatment under review and, when reasonably 
                        available, be of the same specialty as the 
                        physician treating the participant or 
                        beneficiary or recommending or prescribing the 
                        treatment in question;
                            ``(iv) receive only reasonable and 
                        customary compensation from the group health 
                        plan or health insurance issuer in connection 
                        with the independent external review that is 
                        not contingent on the decision rendered by the 
                        reviewer; and
                            ``(v) not be held liable for decisions 
                        regarding medical determinations (but may be 
                        held liable for actions that are arbitrary and 
                        capricious).
            ``(4) Standard of review.--
                    ``(A) In general.--An independent external reviewer 
                shall--
                            ``(i) make an independent determination 
                        based on the valid, relevant, scientific and 
                        clinical evidence to determine the medical 
                        necessity, appropriateness, experimental or 
                        investigational nature of the proposed 
                        treatment; and
                            ``(ii) take into consideration appropriate 
                        and available information, including any 
                        evidence-based decision making or clinical 
                        practice guidelines used by the group health 
                        plan or health insurance issuer; timely 
                        evidence or information submitted by the plan, 
                        issuer, patient or patient's physician; the 
                        patient's medical record; expert consensus; and 
                        medical literature as defined in section 556(5) 
                        of the Federal Food, Drug, and Cosmetic Act.
                    ``(B) Notice.--The plan or issuer involved shall 
                ensure that the participant or beneficiary receives 
                notice, within 30 days after the determination of the 
                independent medical expert, regarding the actions of 
                the plan or issuer with respect to the determination of 
                such expert under the independent external review.
            ``(5) Timeframe for review.--
                    ``(A) In general.--The independent external 
                reviewer shall complete a review of an adverse coverage 
                determination in accordance with the medical exigencies 
                of the case.
                    ``(B) Limitation.--Notwithstanding subparagraph 
                (A), a review described in such subparagraph shall be 
                completed not later than 30 working days after the 
                later of--
                            ``(i) the date on which such reviewer is 
                        designated; or
                            ``(ii) the date on which all information 
                        necessary to completing such review is 
                        received.
            ``(6) Binding determination.--The determination of an 
        independent external reviewer under this subsection shall be 
        binding upon the plan or issuer if the provisions of this 
        subsection or the procedures implemented under such provisions 
        were complied with by the independent external reviewer.
            ``(7) Study.--Not later than 2 years after the date of 
        enactment of this section, the General Accounting Office shall 
        conduct a study of a statistically appropriate sample of 
        completed independent external reviews. Such study shall 
        include an assessment of the process involved during an 
        independent external review and the basis of decisionmaking by 
        the independent external reviewer. The results of such study 
        shall be submitted to the appropriate committees of Congress.
            ``(8) Effect on certain provisions.--Nothing in this 
        section shall be construed as affecting or modifying section 
        514 of this Act with respect to a group health plan.
    ``(f) Rule of Construction.--Nothing in this section shall be 
construed to prohibit a plan administrator or plan fiduciary or health 
plan medical director from requesting an independent external review by 
an independent external reviewer without first completing the internal 
review process.
    ``(g) Definitions.--In this section:
            ``(1) Adverse coverage determination.--The term `adverse 
        coverage determination' means a coverage determination under 
        the plan which results in a denial of coverage or 
        reimbursement.
            ``(2) Coverage determination.--The term `coverage 
        determination' means with respect to items and services for 
        which coverage may be provided under a health plan, a 
        determination of whether or not such items and services are 
        covered or reimbursable under the coverage and terms of the 
        contract.
            ``(3) Grievance.--The term `grievance' means any complaint 
        made by a participant or beneficiary that does not involve a 
        coverage determination.
            ``(4) Group health plan.--The term `group health plan' 
        shall have the meaning given such term in section 733(a). In 
        applying this paragraph, excepted benefits described in section 
        733(c) shall not be treated as benefits consisting of medical 
        care.
            ``(5) Health insurance coverage.--The term `health 
        insurance coverage' has the meaning given such term in section 
        733(b)(1). In applying this paragraph, excepted benefits 
        described in section 733(c) shall not be treated as benefits 
        consisting of medical care.
            ``(6) Health insurance issuer.--The term `health insurance 
        issuer' has the meaning given such term in section 733(b)(2).
            ``(7) Prior authorization determination.--The term `prior 
        authorization determination' means a coverage determination 
        prior to the provision of the items and services as a condition 
        of coverage of the items and services under the coverage.
            ``(8) Treating health care professional.--The term 
        `treating health care professional' with respect to a group 
        health plan, health insurance issuer or provider sponsored 
        organization means a physician (medical doctor or doctor of 
        osteopathy) or other health care practitioner who is acting 
        within the scope of his or her State licensure or certification 
for the delivery of health care services and who is primarily 
responsible for delivering those services to the participant or 
beneficiary.
            ``(9) Utilization review.--The term `utilization review' 
        with respect to a group health plan or health insurance 
        coverage means a set of formal techniques designed to monitor 
        the use of, or evaluate the clinical necessity, 
        appropriateness, efficacy, or efficiency of, health care 
        services, procedures, or settings. Techniques may include 
        ambulatory review, prospective review, second opinion, 
        certification, concurrent review, case management, discharge 
        planning or retrospective review.''
    (b) Enforcement.--Section 502(c)(1) of the Employee Retirement 
Income Security Act of 1974 (29 U.S.C. 1132(c)(1)) is amended by 
inserting after ``or section 101(e)(1)'' the following: ``, or fails to 
comply with a coverage determination as required under section 
503(e)(6),''.
    (c) Conforming Amendment.--The table of contents in section 1 of 
the Employee Retirement Income Security Act of 1974 is amended by 
striking the item relating to section 503 and inserting the following 
new item:

``Sec. 503. Claims procedures, coverage determination, grievances and 
                            appeals.''.
    (d) Effective Date.--The amendments made by this section shall 
apply with respect to plan years beginning on or after 1 year after the 
date of enactment of this Act. The Secretary shall issue all 
regulations necessary to carry out the amendments made by this section 
before the effective date thereof.

               TITLE II--GENETIC INFORMATION AND SERVICES

SEC. 201. SHORT TITLE.

    This title may be cited as the ``Genetic Information 
Nondiscrimination in Health Insurance Act of 1999''.

SEC. 202. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 
              1974.

    (a) Prohibition of Health Discrimination on the Basis of Genetic 
Information or Genetic Services.--
            (1) No enrollment restriction for genetic services.--
        Section 702(a)(1)(F) of the Employee Retirement Income Security 
        Act of 1974 (29 U.S.C. 1182(a)(1)(F)) is amended by inserting 
        before the period the following: ``(including information about 
        a request for or receipt of genetic services)''.
            (2) No discrimination in group premiums based on predictive 
        genetic information.--Subpart B of part 7 of subtitle B of 
        title I of the Employee Retirement Income Security Act of 1974, 
        as amended by section 111(a), is further amended by adding at 
        the end the following:

``SEC. 715. PROHIBITING PREMIUM DISCRIMINATION AGAINST GROUPS ON THE 
              BASIS OF PREDICTIVE GENETIC INFORMATION.

    ``A group health plan, or a health insurance issuer offering group 
health insurance coverage in connection with a group health plan, shall 
not adjust premium or contribution amounts for a group on the basis of 
predictive genetic information concerning any individual (including a 
dependent) or family member of the individual (including information 
about a request for or receipt of genetic services).''.
            (3) Conforming amendments.--
                    (A) In general.--Section 702(b) of the Employee 
                Retirement Income Security Act of 1974 (29 U.S.C. 
                1182(b)) is amended by adding at the end the following:
            ``(3) Reference to related provision.--For a provision 
        prohibiting the adjustment of premium or contribution amounts 
        for a group under a group health plan on the basis of 
        predictive genetic information (including information about a 
        request for or receipt of genetic services), see section 
        715.''.
                    (B) Table of contents.--The table of contents in 
                section 1 of the Employee Retirement Income Security 
                Act of 1974, as amended by section 111(a), is further 
                amended by inserting after the item relating to section 
                714 the following new item:

``Sec. 715. Prohibiting premium discrimination against groups on the 
                            basis of predictive genetic information.''.
    (b) Limitation on Collection of Predictive Genetic Information.--
Section 702 of the Employee Retirement Income Security Act of 1974 (29 
U.S.C. 1182) is amended by adding at the end the following:
    ``(c) Collection of Predictive Genetic Information.--
            ``(1) Limitation on requesting or requiring predictive 
        genetic information.--Except as provided in paragraph (2), a 
        group health plan, or a health insurance issuer offering health 
        insurance coverage in connection with a group health plan, 
        shall not request or require predictive genetic information 
        concerning any individual (including a dependent) or family 
        member of the individual (including information about a request 
        for or receipt of genetic services).
            ``(2) Information needed for diagnosis, treatment, or 
        payment.--
                    ``(A) In general.--Notwithstanding paragraph (1), a 
                group health plan, or a health insurance issuer 
                offering health insurance coverage in connection with a 
                group health plan, that provides health care items and 
                services to an individual or dependent may request (but 
                may not require) that such individual or dependent 
                disclose, or authorize the collection or disclosure of, 
                predictive genetic information for purposes of 
                diagnosis, treatment, or payment relating to the 
                provision of health care items and services to such 
                individual or dependent.
                    ``(B) Notice of confidentiality practices and 
                description of safeguards.--As a part of a request 
                under subparagraph (A), the group health plan, or a 
                health insurance issuer offering health insurance 
                coverage in connection with a group health plan, shall 
                provide to the individual or dependent a description of 
                the procedures in place to safeguard the 
                confidentiality, as described in subsection (d), of 
                such predictive genetic information.
    ``(d) Confidentiality with Respect to Predictive Genetic 
Information.--
            ``(1) Notice of confidentiality practices.--
                    ``(A) Preparation of written notice.--A group 
                health plan, or a health insurance issuer offering 
                health insurance coverage in connection with a group 
                health plan, shall post or provide, in writing and in a 
                clear and conspicuous manner, notice of the plan or 
                issuer's confidentiality practices, that shall 
                include--
                            ``(i) a description of an individual's 
                        rights with respect to predictive genetic 
                        information;
                            ``(ii) the procedures established by the 
                        plan or issuer for the exercise of the 
                        individual's rights; and
                            ``(iii) the right to obtain a copy of the 
                        notice of the confidentiality practices 
                        required under this subsection.
                    ``(B) Model notice.--The Secretary, in consultation 
                with the National Committee on Vital and Health 
                Statistics and the National Association of Insurance 
                Commissioners, and after notice and opportunity for 
                public comment, shall develop and disseminate model 
                notices of confidentiality practices. Use of the model 
                notice shall serve as a defense against claims of 
                receiving inappropriate notice.
            ``(2) Establishment of safeguards.--A group health plan, or 
        a health insurance issuer offering health insurance coverage in 
        connection with a group health plan, shall establish and 
        maintain appropriate administrative, technical, and physical 
        safeguards to protect the confidentiality, security, accuracy, 
        and integrity of predictive genetic information created, 
        received, obtained, maintained, used, transmitted, or disposed 
        of by such plan or issuer.''.
    (c) Definitions.--Section 733(d) of the Employee Retirement Income 
Security Act of 1974 (29 U.S.C. 1191b(d)) is amended by adding at the 
end the following:
            ``(5) Family member.--The term `family member' means with 
        respect to an individual--
                    ``(A) the spouse of the individual;
                    ``(B) a dependent child of the individual, 
                including a child who is born to or placed for adoption 
                with the individual; and
                    ``(C) all other individuals related by blood to the 
                individual or the spouse or child described in 
                subparagraph (A) or (B).
            ``(6) Genetic information.--The term `genetic information' 
        means information about genes, gene products, or inherited 
        characteristics that may derive from an individual or a family 
        member (including information about a request for or receipt of 
        genetic services).
            ``(7) Genetic services.--The term `genetic services' means 
        health services provided to obtain, assess, or interpret 
        genetic information for diagnostic and therapeutic purposes, 
        and for genetic education and counseling.
            ``(8) Predictive genetic information.--
                    ``(A) In general.--The term `predictive genetic 
                information' means, in the absence of symptoms, 
                clinical signs, or a diagnosis of the condition related 
                to such information--
                            ``(i) information about an individual's 
                        genetic tests;
                            ``(ii) information about genetic tests of 
                        family members of the individual; or
                            ``(iii) information about the occurrence of 
                        a disease or disorder in family members.
                    ``(B) Exceptions.--The term `predictive genetic 
                information' shall not include--
                            ``(i) information about the sex or age of 
                        the individual;
                            ``(ii) information derived from physical 
                        tests, such as the chemical, blood, or urine 
                        analyses of the individual including 
                        cholesterol tests; and
                            ``(iii) information about physical exams of 
                        the individual.
            ``(9) Genetic test.--The term `genetic test' means the 
        analysis of human DNA, RNA, chromosomes, proteins, and certain 
        metabolites, including analysis of genotypes, mutations, 
        phenotypes, or karyotypes, for the purpose of predicting risk 
        of disease in asymptomatic or undiagnosed individuals. Such 
        term does not include physical tests, such as the chemical, 
        blood, or urine analyses of the individual including 
        cholesterol tests, and physical exams of the individual, in 
        order to detect symptoms, clinical signs, or a diagnosis of 
        disease.''.
    (d) Effective Date.--Except as provided in this section, this 
section and the amendments made by this section shall apply with 
respect to group health plans for plan years beginning 1 year after the 
date of the enactment of this Act.

SEC. 203. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.

    (a) Amendments Relating to the Group Market.--
            (1) Prohibition of health discrimination on the basis of 
        genetic information in the group market.--
                    (A) No enrollment restriction for genetic 
                services.--Section 2702(a)(1)(F) of the Public Health 
                Service Act (42 U.S.C. 300gg-1(a)(1)(F)) is amended by 
                inserting before the period the following: ``(including 
                information about a request for or receipt of genetic 
                services)''.
                    (B) No discrimination in premiums based on 
                predictive genetic information.--Subpart 2 of part A of 
                title XXVII of the Public Health Service Act, as 
                amended by the Omnibus Consolidated and Emergency 
                Supplemental Appropriations Act, 1999 (Public Law 105-
                277), is amended by adding at the end the following new 
                section:

``SEC. 2707. PROHIBITING PREMIUM DISCRIMINATION AGAINST GROUPS ON THE 
              BASIS OF PREDICTIVE GENETIC INFORMATION IN THE GROUP 
              MARKET.

    ``A group health plan, or a health insurance issuer offering group 
health insurance coverage in connection with a group health plan shall 
not adjust premium or contribution amounts for a group on the basis of 
predictive genetic information concerning any individual (including a 
dependent) or family member of the individual (including information 
about a request for or receipt of genetic services).''.
                    (C) Conforming amendment.--Section 2702(b) of the 
                Public Health Service Act (42 U.S.C. 300gg-1(b)) is 
                amended by adding at the end the following:
            ``(3) Reference to related provision.--For a provision 
        prohibiting the adjustment of premium or contribution amounts 
        for a group under a group health plan on the basis of 
        predictive genetic information (including information about a 
        request for or receipt of genetic services), see section 
        2707.''.
                    (D) Limitation on collection and disclosure of 
                predictive genetic information.--Section 2702 of the 
                Public Health Service Act (42 U.S.C. 300gg-1) is 
                amended by adding at the end the following:
    ``(c) Collection of Predictive Genetic Information.--
            ``(1) Limitation on requesting or requiring predictive 
        genetic information.--Except as provided in paragraph (2), a 
        group health plan, or a health insurance issuer offering health 
        insurance coverage in connection with a group health plan, 
        shall not request or require predictive genetic information 
        concerning any individual (including a dependent) or a family 
        member of the individual (including information about a request 
        for or receipt of genetic services).
            ``(2) Information needed for diagnosis, treatment, or 
        payment.--
                    ``(A) In general.--Notwithstanding paragraph (1), a 
                group health plan, or a health insurance issuer 
                offering health insurance coverage in connection with a 
                group health plan, that provides health care items and 
                services to an individual or dependent may request (but 
                may not require) that such individual or dependent 
                disclose, or authorize the collection or disclosure of, 
                predictive genetic information for purposes of 
                diagnosis, treatment, or payment relating to the 
                provision of health care items and services to such 
                individual or dependent.
                    ``(B) Notice of confidentiality practices and 
                description of safeguards.--As a part of a request 
                under subparagraph (A), the group health plan, or a 
                health insurance issuer offering health insurance 
                coverage in connection with a group health plan, shall 
                provide to the individual or dependent a description of 
                the procedures in place to safeguard the 
                confidentiality, as described in subsection (d), of 
                such predictive genetic information.
    ``(d) Confidentiality with Respect to Predictive Genetic 
Information.--
            ``(1) Notice of confidentiality practices.--
                    ``(A) Preparation of written notice.--A group 
                health plan, or a health insurance issuer offering 
                health insurance coverage in connection with a group 
                health plan, shall post or provide, in writing and in a 
                clear and conspicuous manner, notice of the plan or 
                issuer's confidentiality practices, that shall 
                include--
                            ``(i) a description of an individual's 
                        rights with respect to predictive genetic 
                        information;
                            ``(ii) the procedures established by the 
                        plan or issuer for the exercise of the 
                        individual's rights; and
                            ``(iii) the right to obtain a copy of the 
                        notice of the confidentiality practices 
                        required under this subsection.
                    ``(B) Model notice.--The Secretary, in consultation 
                with the National Committee on Vital and Health 
                Statistics and the National Association of Insurance 
                Commissioners, and after notice and opportunity for 
                public comment, shall develop and disseminate model 
                notices of confidentiality practices. Use of the model 
                notice shall serve as a defense against claims of 
                receiving inappropriate notice.
            ``(2) Establishment of safeguards.--A group health plan, or 
        a health insurance issuer offering health insurance coverage in 
        connection with a group health plan, shall establish and 
        maintain appropriate administrative, technical, and physical 
        safeguards to protect the confidentiality, security, accuracy, 
        and integrity of predictive genetic information created, 
        received, obtained, maintained, used, transmitted, or disposed 
        of by such plan or issuer.''.
            (2) Definitions.--Section 2791(d) of the Public Health 
        Service Act (42 U.S.C. 300gg-91(d)) is amended by adding at the 
        end the following:
            ``(15) Family member.--The term `family member' means, with 
        respect to an individual--
                    ``(A) the spouse of the individual;
                    ``(B) a dependent child of the individual, 
                including a child who is born to or placed for adoption 
                with the individual; and
                    ``(C) all other individuals related by blood to the 
                individual or the spouse or child described in 
                subparagraph (A) or (B).
            ``(16) Genetic information.--The term `genetic information' 
        means information about genes, gene products, or inherited 
        characteristics that may derive from an individual or a family 
        member (including information about a request for or receipt of 
        genetic services).
            ``(17) Genetic services.--The term `genetic services' means 
        health services provided to obtain, assess, or interpret 
        genetic information for diagnostic and therapeutic purposes, 
        and for genetic education and counseling.
            ``(18) Predictive genetic information.--
                    ``(A) In general.--The term `predictive genetic 
                information' means, in the absence of symptoms, 
                clinical signs, or a diagnosis of the condition related 
                to such information--
                            ``(i) information about an individual's 
                        genetic tests;
                            ``(ii) information about genetic tests of 
                        family members of the individual; or
                            ``(iii) information about the occurrence of 
                        a disease or disorder in family members.
                    ``(B) Exceptions.--The term `predictive genetic 
                information' shall not include--
                            ``(i) information about the sex or age of 
                        the individual;
                            ``(ii) information derived from physical 
                        tests, such as the chemical, blood, or urine 
                        analyses of the individual including 
                        cholesterol tests; and
                            ``(iii) information about physical exams of 
                        the individual.
            ``(19) Genetic test.--The term `genetic test' means the 
        analysis of human DNA, RNA, chromosomes, proteins, and certain 
        metabolites, including analysis of genotypes, mutations, 
        phenotypes, or karyotypes, for the purpose of predicting risk 
        of disease in asymptomatic or undiagnosed individuals. Such 
        term does not include physical tests, such as the chemical, 
        blood, or urine analyses of the individual including 
        cholesterol tests, and physical exams of the individual, in 
        order to detect symptoms, clinical signs, or a diagnosis of 
        disease.''.
    (b) Amendment Relating to the Individual Market.--The first subpart 
3 of part B of title XXVII of the Public Health Service Act (42 U.S.C. 
300gg-51 et seq.) (relating to other requirements), as amended by the 
Omnibus Consolidated and Emergency Supplemental Appropriations Act, 
1999 (Public Law 105-277) is amended--
            (1) by redesignating such subpart as subpart 2; and
            (2) by adding at the end the following:

``SEC. 2753. PROHIBITION OF HEALTH DISCRIMINATION ON THE BASIS OF 
              PREDICTIVE GENETIC INFORMATION.

    ``(a) Prohibition on Predictive Genetic Information as a Condition 
of Eligibility.--A health insurance issuer offering health insurance 
coverage in the individual market may not use predictive genetic 
information as a condition of eligibility of an individual to enroll in 
individual health insurance coverage (including information about a 
request for or receipt of genetic services).
    ``(b) Prohibition on Predictive Genetic Information in Setting 
Premium Rates.--A health insurance issuer offering health insurance 
coverage in the individual market shall not adjust premium rates for 
individuals on the basis of predictive genetic information concerning 
such an individual (including a dependent) or a family member of the 
individual (including information about a request for or receipt of 
genetic services).
    ``(c) Collection of Predictive Genetic Information.--
            ``(1) Limitation on requesting or requiring predictive 
        genetic information.--Except as provided in paragraph (2), a 
        health insurance issuer offering health insurance coverage in 
        the individual market shall not request or require predictive 
        genetic information concerning any individual (including a 
        dependent) or a family member of the individual (including 
        information about a request for or receipt of genetic 
        services).
            ``(2) Information needed for diagnosis, treatment, or 
        payment.--
                    ``(A) in general.--Notwithstanding paragraph (1), a 
                health insurance issuer offering health insurance 
                coverage in the individual market that provides health 
                care items and services to an individual or dependent 
                may request (but may not require) that such individual 
                or dependent disclose, or authorize the collection or 
                disclosure of, predictive genetic information for 
                purposes of diagnosis, treatment, or payment relating 
                to the provision of health care items and services to 
                such individual or dependent.
                    ``(B) Notice of confidentiality practices and 
                description of safeguards.--As a part of a request 
                under subparagraph (A), the health insurance issuer 
                offering health insurance coverage in the individual 
                market shall provide to the individual or dependent a 
                description of the procedures in place to safeguard the 
                confidentiality, as described in subsection (d), of 
                such predictive genetic information.
    ``(d) Confidentiality with Respect to Predictive Genetic 
Information.--
            ``(1) Notice of confidentiality practices.--
                    ``(A) Preparation of written notice.--A health 
                insurance issuer offering health insurance coverage in 
                the individual market shall post or provide, in writing 
                and in a clear and conspicuous manner, notice of the 
                issuer's confidentiality practices, that shall 
                include--
                            ``(i) a description of an individual's 
                        rights with respect to predictive genetic 
                        information;
                            ``(ii) the procedures established by the 
                        issuer for the exercise of the individual's 
                        rights; and
                            ``(iii) the right to obtain a copy of the 
                        notice of the confidentiality practices 
                        required under this subsection.
                    ``(B) Model notice.--The Secretary, in consultation 
                with the National Committee on Vital and Health 
                Statistics and the National Association of Insurance 
                Commissioners, and after notice and opportunity for 
                public comment, shall develop and disseminate model 
                notices of confidentiality practices. Use of the model 
                notice shall serve as a defense against claims of 
                receiving inappropriate notice.
            ``(2) Establishment of safeguards.--A health insurance 
        issuer offering health insurance coverage in the individual 
        market shall establish and maintain appropriate administrative, 
        technical, and physical safeguards to protect the 
        confidentiality, security, accuracy, and integrity of 
        predictive genetic information created, received, obtained, 
        maintained, used, transmitted, or disposed of by such 
        issuer.''.
    (c) Effective Date.--The amendments made by this section shall 
apply with respect to--
            (1) group health plans, and health insurance coverage 
        offered in connection with group health plans, for plan years 
        beginning after 1 year after the date of enactment of this Act; 
        and
            (2) health insurance coverage offered, sold, issued, 
        renewed, in effect, or operated in the individual market after 
        1 year after the date of enactment of this Act.

SEC. 204. AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986.

    (a) Prohibition of Health Discrimination on the Basis of Genetic 
Information or Genetic Services.--
            (1) No enrollment restriction for genetic services.--
        Section 9802(a)(1)(F) of the Internal Revenue Code of 1986 is 
        amended by inserting before the period the following: 
        ``(including information about a request for or receipt of 
        genetic services)''.
            (2) No discrimination in group premiums based on predictive 
        genetic information.--
                    (A) In general.--Subchapter B of chapter 100 of the 
                Internal Revenue Code of 1986, as amended by section 
                111(b), is further amended by adding at the end the 
                following:

``SEC. 9814. PROHIBITING PREMIUM DISCRIMINATION AGAINST GROUPS ON THE 
              BASIS OF PREDICTIVE GENETIC INFORMATION.

    ``A group health plan shall not adjust premium or contribution 
amounts for a group on the basis of predictive genetic information 
concerning any individual (including a dependent) or a family member of 
the individual (including information about a request for or receipt of 
genetic services).''.
                    (B) Conforming amendment.--Section 9802(b) of the 
                Internal Revenue Code of 1986 is amended by adding at 
                the end the following:
            ``(3) Reference to related provision.--For a provision 
        prohibiting the adjustment of premium or contribution amounts 
        for a group under a group health plan on the basis of 
        predictive genetic information (including information about a 
        request for or the receipt of genetic services), see section 
        9814.''.
                    (C) Amendment to table of sections.--The table of 
                sections for subchapter B of chapter 100 of the 
                Internal Revenue Code of 1986, as amended by section 
                111(b), is further amended by adding at the end the 
                following:

``Sec. 9814. Prohibiting premium discrimination against groups on the 
                            basis of predictive genetic information.''.
    (b) Limitation on Collection of Predictive Genetic Information.--
Section 9802 of the Internal Revenue Code of 1986 is amended by adding 
at the end the following:
    ``(d) Collection of Predictive Genetic Information.--
            ``(1) Limitation on requesting or requiring predictive 
        genetic information.--Except as provided in paragraph (2), a 
        group health plan shall not request or require predictive 
        genetic information concerning any individual (including a 
        dependent) or a family member of the individual (including 
        information about a request for or receipt of genetic 
        services).
            ``(2) Information needed for diagnosis, treatment, or 
        payment.--
                    ``(A) In general.--Notwithstanding paragraph (1), a 
                group health plan that provides health care items and 
                services to an individual or dependent may request (but 
                may not require) that such individual or dependent 
                disclose, or authorize the collection or disclosure of, 
                predictive genetic information for purposes of 
                diagnosis, treatment, or payment relating to the 
                provision of health care items and services to such 
                individual or dependent.
                    ``(B) Notice of confidentiality practices; 
                description of safeguards.--As a part of a request 
                under subparagraph (A), the group health plan shall 
                provide to the individual or dependent a description of 
                the procedures in place to safeguard the 
                confidentiality, as described in subsection (e), of 
                such predictive genetic information.
    ``(e) Confidentiality with Respect to Predictive Genetic 
Information.--
            ``(1) Notice of confidentiality practices.--
                    ``(A) Preparation of written notice.--A group 
                health plan shall post or provide, in writing and in a 
                clear and conspicuous manner, notice of the plan's 
                confidentiality practices, that shall include--
                            ``(i) a description of an individual's 
                        rights with respect to predictive genetic 
                        information;
                            ``(ii) the procedures established by the 
                        plan for the exercise of the individual's 
                        rights; and
                            ``(iii) the right to obtain a copy of the 
                        notice of the confidentiality practices 
                        required under this subsection.
                    ``(B) Model notice.--The Secretary, in consultation 
                with the National Committee on Vital and Health 
                Statistics and the National Association of Insurance 
                Commissioners, and after notice and opportunity for 
                public comment, shall develop and disseminate model 
                notices of confidentiality practices. Use of the model 
                notice shall serve as a defense against claims of 
                receiving inappropriate notice.
            ``(2) Establishment of safeguards.--A group health plan 
        shall establish and maintain appropriate administrative, 
        technical, and physical safeguards to protect the 
        confidentiality, security, accuracy, and integrity of 
        predictive genetic information created, received, obtained, 
        maintained, used, transmitted, or disposed of by such plan.''.
    (c) Definitions.--Section 9832(d) of the Internal Revenue Code of 
1986 is amended by adding at the end the following:
            ``(6) Family member.--The term `family member' means, with 
        respect to an individual--
                    ``(A) the spouse of the individual;
                    ``(B) a dependent child of the individual, 
                including a child who is born to or placed for adoption 
                with the individual; and
                    ``(C) all other individuals related by blood to the 
                individual or the spouse or child described in 
                subparagraph (A) or (B).
            ``(7) Genetic information.--The term `genetic information' 
        means information about genes, gene products, or inherited 
        characteristics that may derive from an individual or a family 
        member (including information about a request for or receipt of 
        genetic services).
            ``(8) Genetic services.--The term `genetic services' means 
        health services provided to obtain, assess, or interpret 
        genetic information for diagnostic and therapeutic purposes, 
        and for genetic education and counseling.
            ``(9) Predictive genetic information.--
                    ``(A) In general.--The term `predictive genetic 
                information' means, in the absence of symptoms, 
                clinical signs, or a diagnosis of the condition related 
                to such information--
                            ``(i) information about an individual's 
                        genetic tests;
                            ``(ii) information about genetic tests of 
                        family members of the individual; or
                            ``(iii) information about the occurrence of 
                        a disease or disorder in family members.
                    ``(B) Exceptions.--The term `predictive genetic 
                information' shall not include--
                            ``(i) information about the sex or age of 
                        the individual;
                            ``(ii) information derived from physical 
                        tests, such as the chemical, blood, or urine 
                        analyses of the individual including 
                        cholesterol tests; and
                            ``(iii) information about physical exams of 
                        the individual.
            ``(10) Genetic test.--The term `genetic test' means the 
        analysis of human DNA, RNA, chromosomes, proteins, and certain 
        metabolites, including analysis of genotypes, mutations, 
        phenotypes, or karyotypes, for the purpose of predicting risk 
        of disease in asymptomatic or undiagnosed individuals. Such 
        term does not include physical tests, such as the chemical, 
        blood, or urine analyses of the individual including 
        cholesterol tests, and physical exams of the individual, in 
        order to detect symptoms, clinical signs, or a diagnosis of 
        disease.''.
    (d) Effective Date.--Except as provided in this section, this 
section and the amendments made by this section shall apply with 
respect to group health plans for plan years beginning after 1 year 
after the date of the enactment of this Act.

               TITLE III--HEALTHCARE RESEARCH AND QUALITY

SEC. 301. SHORT TITLE.

    This title may be cited as the ``Healthcare Research and Quality 
Act of 1999''.

SEC. 302. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

    Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) 
is amended to read as follows:

         ``TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

               ``PART A--ESTABLISHMENT AND GENERAL DUTIES

``SEC. 901. MISSION AND DUTIES.

    ``(a) In General.--There is established within the Public Health 
Service an agency to be known as the Agency for Healthcare Research and 
Quality. In carrying out this subsection, the Secretary shall 
redesignate the Agency for Health Care Policy and Research as the 
Agency for Healthcare Research and Quality.
    ``(b) Mission.--The purpose of the Agency is to enhance the 
quality, appropriateness, and effectiveness of healthcare services, and 
access to such services, through the establishment of a broad base of 
scientific research and through the promotion of improvements in 
clinical and health system practices, including the prevention of 
diseases and other health conditions. The Agency shall promote 
healthcare quality improvement by--
            ``(1) conducting and supporting research that develops and 
        presents scientific evidence regarding all aspects of 
        healthcare, including--
                    ``(A) the development and assessment of methods for 
                enhancing patient participation in their own care and 
                for facilitating shared patient-physician decision-
                making;
                    ``(B) the outcomes, effectiveness, and cost-
                effectiveness of healthcare practices, including 
                preventive measures and long-term care;
                    ``(C) existing and innovative technologies;
                    ``(D) the costs and utilization of, and access to 
                healthcare;
                    ``(E) the ways in which healthcare services are 
                organized, delivered, and financed and the interaction 
                and impact of these factors on the quality of patient 
                care;
                    ``(F) methods for measuring quality and strategies 
                for improving quality; and
                    ``(G) ways in which patients, consumers, 
                purchasers, and practitioners acquire new information 
                about best practices and health benefits, the 
                determinants and impact of their use of this 
                information;
            ``(2) synthesizing and disseminating available scientific 
        evidence for use by patients, consumers, practitioners, 
        providers, purchasers, policy makers, and educators; and
            ``(3) advancing private and public efforts to improve 
        healthcare quality.
    ``(c) Requirements With Respect to Rural Areas and Priority 
Populations.--In carrying out subsection (b), the Director shall 
undertake and support research, demonstration projects, and evaluations 
with respect to the delivery of health services--
            ``(1) in rural areas (including frontier areas);
            ``(2) for low-income groups, and minority groups;
            ``(3) for children;
            ``(4) for elderly; and
            ``(5) for people with special healthcare needs, including 
        disabilities, chronic care and end-of-life healthcare.
    ``(d) Appointment of Director.--There shall be at the head of the 
Agency an official to be known as the Director for Healthcare Research 
and Quality. The Director shall be appointed by the Secretary. The 
Secretary, acting through the Director, shall carry out the authorities 
and duties established in this title.

``SEC. 902. GENERAL AUTHORITIES.

    ``(a) In General.--In carrying out section 901(b), the Director 
shall support demonstration projects, conduct and support research, 
evaluations, training, research networks, multi-disciplinary centers, 
technical assistance, and the dissemination of information, on 
healthcare, and on systems for the delivery of such care, including 
activities with respect to--
            ``(1) the quality, effectiveness, efficiency, 
        appropriateness and value of healthcare services;
            ``(2) quality measurement and improvement;
            ``(3) the outcomes, cost, cost-effectiveness, and use of 
        healthcare services and access to such services;
            ``(4) clinical practice, including primary care and 
        practice-oriented research;
            ``(5) healthcare technologies, facilities, and equipment;
            ``(6) healthcare costs, productivity, organization, and 
        market forces;
            ``(7) health promotion and disease prevention, including 
        clinical preventive services;
            ``(8) health statistics, surveys, database development, and 
        epidemiology; and
            ``(9) medical liability.
    ``(b) Health Services Training Grants.--
            ``(1) In general.--The Director may provide training grants 
        in the field of health services research related to activities 
        authorized under subsection (a), to include pre- and post-
        doctoral fellowships and training programs, young investigator 
        awards, and other programs and activities as appropriate. In 
        carrying out this subsection, the Director shall make use of 
        funds made available under section 487 as well as other 
        appropriated funds.
            ``(2) Requirements.--In developing priorities for the 
        allocation of training funds under this subsection, the 
        Director shall take into consideration shortages in the number 
        of trained researchers addressing the priority populations.
    ``(c) Multidisciplinary Centers.--The Director may provide 
financial assistance to assist in meeting the costs of planning and 
establishing new centers, and operating existing and new centers, for 
multidisciplinary health services research, demonstration projects, 
evaluations, training, and policy analysis with respect to the matters 
referred to in subsection (a).
    ``(d) Relation to Certain Authorities Regarding Social Security.--
Activities authorized in this section shall be appropriately 
coordinated with experiments, demonstration projects, and other related 
activities authorized by the Social Security Act and the Social 
Security Amendments of 1967. Activities under subsection (a)(2) of this 
section that affect the programs under titles XVIII, XIX and XXI of the 
Social Security Act shall be carried out consistent with section 1142 
of such Act.
    ``(e) Disclaimer.--The Agency shall not mandate national standards 
of clinical practice or quality healthcare standards. Recommendations 
resulting from projects funded and published by the Agency shall 
include a corresponding disclaimer.
    ``(f) Rule of Construction.--Nothing in this section shall be 
construed to imply that the Agency's role is to mandate a national 
standard or specific approach to quality measurement and reporting. In 
research and quality improvement activities, the Agency shall consider 
a wide range of choices, providers, healthcare delivery systems, and 
individual preferences.

               ``PART B--HEALTHCARE IMPROVEMENT RESEARCH

``SEC. 911. HEALTHCARE OUTCOME IMPROVEMENT RESEARCH.

    ``(a) Evidence Rating Systems.--In collaboration with experts from 
the public and private sector, the Agency shall identify and 
disseminate methods or systems that it uses to assess healthcare 
research results, particularly methods or systems that it uses to rate 
the strength of the scientific evidence behind healthcare practice, 
recommendations in the research literature, and technology assessments. 
The Agency shall make methods and systems for evidence rating widely 
available. Agency publications containing healthcare recommendations 
shall indicate the level of substantiating evidence using such methods 
or systems.
    ``(b) Healthcare Improvement Research Centers and Provider-Based 
Research Networks.--In order to address the full continuum of care and 
outcomes research, to link research to practice improvement, and to 
speed the dissemination of research findings to community practice 
settings, the Agency shall employ research strategies and mechanisms 
that will link research directly with clinical practice in 
geographically diverse locations throughout the United States, 
including--
            ``(1) Healthcare Improvement Research Centers that combine 
        demonstrated multidisciplinary expertise in outcomes or quality 
        improvement research with linkages to relevant sites of care;
            ``(2) Provider-based Research Networks, including plan, 
        facility, or delivery system sites of care (especially primary 
        care), that can evaluate and promote quality improvement; and
            ``(3) other innovative mechanisms or strategies to link 
        research with clinical practice.

``SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE ORGANIZATION AND 
              DELIVERY.

    ``(a) Support for Efforts To Develop Information on Quality.--
            ``(1) Scientific and technical support.--In its role as the 
        principal agency for healthcare research and quality, the 
        Agency may provide scientific and technical support for private 
        and public efforts to improve healthcare quality, including the 
        activities of accrediting organizations.
            ``(2) Role of the agency.--With respect to paragraph (1), 
        the role of the Agency shall include--
                    ``(A) the identification and assessment of methods 
                for the evaluation of the health of--
                            ``(i) enrollees in health plans by type of 
                        plan, provider, and provider arrangements; and
                            ``(ii) other populations, including those 
                        receiving long-term care services;
                    ``(B) the ongoing development, testing, and 
                dissemination of quality measures, including measures 
                of health and functional outcomes;
                    ``(C) the compilation and dissemination of 
                healthcare quality measures developed in the private 
                and public sector;
                    ``(D) assistance in the development of improved 
                healthcare information systems;
                    ``(E) the development of survey tools for the 
                purpose of measuring participant and beneficiary 
                assessments of their healthcare; and
                    ``(F) identifying and disseminating information on 
                mechanisms for the integration of information on 
                quality into purchaser and consumer decision-making 
                processes.
    ``(b) Centers for Education and Research on Therapeutics.--
            ``(1) In general.--The Secretary, acting through the 
        Director and in consultation with the Commissioner of Food and 
        Drugs, shall establish a program for the purpose of making one 
        or more grants for the establishment and operation of one or 
        more centers to carry out the activities specified in paragraph 
        (2).
            ``(2) Required activities.--The activities referred to in 
        this paragraph are the following:
                    ``(A) The conduct of state-of-the-art clinical, 
                laboratory, or health services research for the 
                following purposes:
                            ``(i) To increase awareness of--
                                    ``(I) new uses of drugs, biological 
                                products, and devices;
                                    ``(II) ways to improve the 
                                effective use of drugs, biological 
                                products, and devices; and
                                    ``(III) risks of new uses and risks 
                                of combinations of drugs and biological 
                                products.
                            ``(ii) To provide objective clinical 
                        information to the following individuals and 
                        entities:
                                    ``(I) Healthcare practitioners and 
                                other providers of healthcare goods or 
                                services.
                                    ``(II) Pharmacists, pharmacy 
                                benefit managers and purchasers.
                                    ``(III) Health maintenance 
                                organizations and other managed 
                                healthcare organizations.
                                    ``(IV) Healthcare insurers and 
                                governmental agencies.
                                    ``(V) Patients and consumers.
                            ``(iii) To improve the quality of 
                        healthcare while reducing the cost of 
                        Healthcare through--
                                    ``(I) an increase in the 
                                appropriate use of drugs, biological 
                                products, or devices; and
                                    ``(II) the prevention of adverse 
                                effects of drugs, biological products, 
                                and devices and the consequences of 
                                such effects, such as unnecessary 
                                hospitalizations.
                    ``(B) The conduct of research on the comparative 
                effectiveness, cost-effectiveness, and safety of drugs, 
                biological products, and devices.
                    ``(C) Such other activities as the Secretary 
                determines to be appropriate, except that grant funds 
                may not be used by the Secretary in conducting 
                regulatory review of new drugs.
    ``(c) Reducing Errors in Medicine.--The Director shall conduct and 
support research and build private-public partnerships to--
            ``(1) identify the causes of preventable healthcare errors 
        and patient injury in healthcare delivery;
            ``(2) develop, demonstrate, and evaluate strategies for 
        reducing errors and improving patient safety; and
            ``(3) promote the implementation of effective strategies 
        throughout the healthcare industry.

``SEC. 913. INFORMATION ON QUALITY AND COST OF CARE.

    ``(a) In General.--In carrying out 902(a), the Director shall--
            ``(1) conduct a survey to collect data on a nationally 
        representative sample of the population on the cost, use and, 
        for fiscal year 2001 and subsequent fiscal years, quality of 
        healthcare, including the types of healthcare services 
        Americans use, their access to healthcare services, frequency 
        of use, how much is paid for the services used, the source of 
        those payments, the types and costs of private health 
        insurance, access, satisfaction, and quality of care for the 
        general population including rural residents and for the 
        populations identified in section 901(c); and
            ``(2) develop databases and tools that provide information 
        to States on the quality, access, and use of healthcare 
        services provided to their residents.
    ``(b) Quality and Outcomes Information.--
            ``(1) In general.--Beginning in fiscal year 2001, the 
        Director shall ensure that the survey conducted under 
        subsection (a)(1) will--
                    ``(A) identify determinants of health outcomes and 
                functional status, and their relationships to 
                healthcare access and use, determine the ways and 
                extent to which the priority populations enumerated in 
                section 901(c) differ from the general population with 
                respect to such variables, measure changes over time 
                with respect to such variable, and monitor the overall 
                national impact of changes in Federal and State policy 
                on healthcare;
                    ``(B) provide information on the quality of care 
                and patient outcomes for frequently occurring clinical 
                conditions for a nationally representative sample of 
                the population including rural residents; and
                    ``(C) provide reliable national estimates for 
                children and persons with special healthcare needs 
                through the use of supplements or periodic expansions 
                of the survey.
        In expanding the Medical Expenditure Panel Survey, as in 
        existence on the date of enactment of this title, in fiscal 
        year 2001 to collect information on the quality of care, the 
        Director shall take into account any outcomes measurements 
        generally collected by private sector accreditation 
        organizations.
            ``(2) Annual report.--Beginning in fiscal year 2003, the 
        Secretary, acting through the Director, shall submit to 
        Congress an annual report on national trends in the quality of 
        healthcare provided to the American people.

``SEC. 914. INFORMATION SYSTEMS FOR HEALTHCARE IMPROVEMENT.

    ``(a) In General.--In order to foster a range of innovative 
approaches to the management and communication of health information, 
the Agency shall support research, evaluations and initiatives to 
advance--
            ``(1) the use of information systems for the study of 
        healthcare quality, including the generation of both individual 
        provider and plan-level comparative performance data;
            ``(2) training for healthcare practitioners and researchers 
        in the use of information systems;
            ``(3) the creation of effective linkages between various 
        sources of health information, including the development of 
        information networks;
            ``(4) the delivery and coordination of evidence-based 
        healthcare services, including the use of real-time healthcare 
        decision-support programs;
            ``(5) the utility and comparability of health information 
        data and medical vocabularies by addressing issues related to 
        the content, structure, definitions and coding of such 
        information and data in consultation with appropriate Federal, 
        State and private entities;
            ``(6) the use of computer-based health records in all 
        settings for the development of personal health records for 
        individual health assessment and maintenance, and for 
        monitoring public health and outcomes of care within 
        populations; and
            ``(7) the protection of individually identifiable 
        information in health services research and healthcare quality 
        improvement.
    ``(b) Demonstration.--The Agency shall support demonstrations into 
the use of new information tools aimed at improving shared decision-
making between patients and their care-givers.

``SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND ACCESS IN UNDERSERVED 
              AREAS.

    ``(a) Preventive Services Task Force.--
            ``(1) Establishment and purpose.--The Director may 
        periodically convene a Preventive Services Task Force to be 
        composed of individuals with appropriate expertise. Such a task 
        force shall review the scientific evidence related to the 
        effectiveness, appropriateness, and cost-effectiveness of 
        clinical preventive services for the purpose of developing 
        recommendations for the healthcare community, and updating 
        previous clinical preventive recommendations.
            ``(2) Role of agency.--The Agency shall provide ongoing 
        administrative, research, and technical support for the 
        operations of the Preventive Services Task Force, including 
        coordinating and supporting the dissemination of the 
        recommendations of the Task Force.
            ``(3) Operation.--In carrying out its responsibilities 
        under paragraph (1), the Task Force is not subject to the 
        provisions of Appendix 2 of title 5, United States Code.
    ``(b) Primary Care Research.--
            ``(1) In general.--There is established within the Agency a 
        Center for Primary Care Research (referred to in this 
        subsection as the `Center') that shall serve as the principal 
source of funding for primary care practice research in the Department 
of Health and Human Services. For purposes of this paragraph, primary 
care research focuses on the first contact when illness or health 
concerns arise, the diagnosis, treatment or referral to specialty care, 
preventive care, and the relationship between the clinician and the 
patient in the context of the family and community.
            ``(2) Research.--In carrying out this section, the Center 
        shall conduct and support research concerning--
                    ``(A) the nature and characteristics of primary 
                care practice;
                    ``(B) the management of commonly occurring clinical 
                problems;
                    ``(C) the management of undifferentiated clinical 
                problems; and
                    ``(D) the continuity and coordination of health 
                services.

``SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVATION.

    ``(a) In General.--The Director shall promote innovation in 
evidence-based clinical practice and healthcare technologies by--
            ``(1) conducting and supporting research on the 
        development, diffusion, and use of healthcare technology;
            ``(2) developing, evaluating, and disseminating 
        methodologies for assessments of healthcare practices and 
        healthcare technologies;
            ``(3) conducting intramural and supporting extramural 
        assessments of existing and new healthcare practices and 
        technologies;
            ``(4) promoting education, training, and providing 
        technical assistance in the use of healthcare practice and 
        healthcare technology assessment methodologies and results; and
            ``(5) working with the National Library of Medicine and the 
        public and private sector to develop an electronic 
        clearinghouse of currently available assessments and those in 
        progress.
    ``(b) Specification of Process.--
            ``(1) In general.--Not later than December 31, 2000, the 
        Director shall develop and publish a description of the 
        methodology used by the Agency and its contractors in 
        conducting practice and technology assessment.
            ``(2) Consultations.--In carrying out this subsection, the 
        Director shall cooperate and consult with the Assistant 
        Secretary for Health, the Administrator of the Health Care 
        Financing Administration, the Director of the National 
        Institutes of Health, the Commissioner of Food and Drugs, and 
        the heads of any other interested Federal department or agency, 
        and shall seek input, where appropriate, from professional 
        societies and other private and public entities.
            ``(3) Methodology.--The Director, in developing assessment 
        methodology, shall consider--
                    ``(A) safety, efficacy, and effectiveness;
                    ``(B) legal, social, and ethical implications;
                    ``(C) costs, benefits, and cost-effectiveness;
                    ``(D) comparisons to alternate technologies and 
                practices; and
                    ``(E) requirements of Food and Drug Administration 
                approval to avoid duplication.
    ``(c) Specific Assessments.--
            ``(1) In general.--The Director shall conduct or support 
        specific assessments of healthcare technologies and practices.
            ``(2) Requests for assessments.--The Director is authorized 
        to conduct or support assessments, on a reimbursable basis, for 
        the Health Care Financing Administration, the Department of 
        Defense, the Department of Veterans Affairs, the Office of 
        Personnel Management, and other public or private entities.
            ``(3) Grants and contracts.--In addition to conducting 
        assessments, the Director may make grants to, or enter into 
        cooperative agreements or contracts with, entities described in 
        paragraph (4) for the purpose of conducting assessments of 
        experimental, emerging, existing, or potentially outmoded 
        healthcare technologies, and for related activities.
            ``(4) Eligible entities.--An entity described in this 
        paragraph is an entity that is determined to be appropriate by 
        the Director, including academic medical centers, research 
        institutions and organizations, professional organizations, 
        third party payers, governmental agencies, and consortia of 
        appropriate research entities established for the purpose of 
        conducting technology assessments.

``SEC. 917. COORDINATION OF FEDERAL GOVERNMENT QUALITY IMPROVEMENT 
              EFFORTS.

    ``(a) Requirement.--
            ``(1) In general.--To avoid duplication and ensure that 
        Federal resources are used efficiently and effectively, the 
        Secretary, acting through the Director, shall coordinate all 
        research, evaluations, and demonstrations related to health 
        services research, quality measurement and quality improvement 
        activities undertaken and supported by the Federal Government.
            ``(2) Specific activities.--The Director, in collaboration 
        with the appropriate Federal officials representing all 
        concerned executive agencies and departments, shall develop and 
        manage a process to--
                    ``(A) improve interagency coordination, priority 
                setting, and the use and sharing of research findings 
                and data pertaining to Federal quality improvement 
                programs, technology assessment, and health services 
                research;
                    ``(B) strengthen the research information 
                infrastructure, including databases, pertaining to 
                Federal health services research and healthcare quality 
                improvement initiatives;
                    ``(C) set specific goals for participating agencies 
                and departments to further health services research and 
                healthcare quality improvement; and
                    ``(D) strengthen the management of Federal 
                healthcare quality improvement programs.
    ``(b) Study by the Institute of Medicine.--
            ``(1) In general.--To provide Congress, the Department of 
        Health and Human Services, and other relevant departments with 
        an independent, external review of their quality oversight, 
quality improvement and quality research programs, the Secretary shall 
enter into a contract with the Institute of Medicine--
                    ``(A) to describe and evaluate current quality 
                improvement, quality research and quality monitoring 
                processes through--
                            ``(i) an overview of pertinent health 
                        services research activities and quality 
                        improvement efforts conducted by all Federal 
                        programs, with particular attention paid to 
                        those under titles XVIII, XIX, and XXI of the 
                        Social Security Act; and
                            ``(ii) a summary of the partnerships that 
                        the Department of Health and Human Services has 
                        pursued with private accreditation, quality 
                        measurement and improvement organizations; and
                    ``(B) to identify options and make recommendations 
                to improve the efficiency and effectiveness of quality 
                improvement programs through--
                            ``(i) the improved coordination of 
                        activities across the medicare, medicaid and 
                        child health insurance programs under titles 
                        XVIII, XIX and XXI of the Social Security Act 
                        and health services research programs;
                            ``(ii) the strengthening of patient choice 
                        and participation by incorporating state-of-
                        the-art quality monitoring tools and making 
                        information on quality available; and
                            ``(iii) the enhancement of the most 
                        effective programs, consolidation as 
                        appropriate, and elimination of duplicative 
                        activities within various federal agencies.
            ``(2) Requirements.--
                    ``(A) In general.--The Secretary shall enter into a 
                contract with the Institute of Medicine for the 
                preparation--
                            ``(i) not later than 12 months after the 
                        date of enactment of this title, of a report 
                        providing an overview of the quality 
                        improvement programs of the Department of 
                        Health and Human Services for the medicare, 
                        medicaid, and CHIP programs under titles XVIII, 
                        XIX, and XXI of the Social Security Act; and
                            ``(ii) not later than 24 months after the 
                        date of enactment of this title, of a final 
                        report containing recommendations.
                    ``(B) Reports.--The Secretary shall submit the 
                reports described in subparagraph (A) to the Committee 
                on Finance and the Committee on Health, Education, 
                Labor, and Pensions of the Senate and the Committee on 
                Ways and Means and the Committee on Commerce of the 
                House of Representatives.

                      ``PART C--GENERAL PROVISIONS

``SEC. 921. ADVISORY COUNCIL FOR HEALTHCARE RESEARCH AND QUALITY.

    ``(a) Establishment.--There is established an advisory council to 
be known as the Advisory Council for Healthcare Research and Quality.
    ``(b) Duties.--
            ``(1) In general.--The Advisory Council shall advise the 
        Secretary and the Director with respect to activities proposed 
        or undertaken to carry out the purpose of the Agency under 
        section 901(b).
            ``(2) Certain recommendations.--Activities of the Advisory 
        Council under paragraph (1) shall include making 
        recommendations to the Director regarding--
                    ``(A) priorities regarding healthcare research, 
                especially studies related to quality, outcomes, cost 
                and the utilization of, and access to, healthcare 
                services;
                    ``(B) the field of healthcare research and related 
                disciplines, especially issues related to training 
                needs, and dissemination of information pertaining to 
                healthcare quality; and
                    ``(C) the appropriate role of the Agency in each of 
                these areas in light of private sector activity and 
                identification of opportunities for public-private 
                sector partnerships.
    ``(c) Membership.--
            ``(1) In general.--The Advisory Council shall, in 
        accordance with this subsection, be composed of appointed 
        members and ex officio members. All members of the Advisory 
        Council shall be voting members other than the individuals 
        designated under paragraph (3)(B) as ex officio members.
            ``(2) Appointed members.--The Secretary shall appoint to 
        the Advisory Council 21 appropriately qualified individuals. At 
        least 17 members of the Advisory Council shall be 
        representatives of the public who are not officers or employees 
        of the United States. The Secretary shall ensure that the 
appointed members of the Council, as a group, are representative of 
professions and entities concerned with, or affected by, activities 
under this title and under section 1142 of the Social Security Act. Of 
such members--
                    ``(A) 4 shall be individuals distinguished in the 
                conduct of research, demonstration projects, and 
                evaluations with respect to healthcare;
                    ``(B) 4 shall be individuals distinguished in the 
                practice of medicine of which at least 1 shall be a 
                primary care practitioner;
                    ``(C) 3 shall be individuals distinguished in the 
                other health professions;
                    ``(D) 4 shall be individuals either representing 
                the private healthcare sector, including health plans, 
                providers, and purchasers or individuals distinguished 
                as administrators of healthcare delivery systems;
                    ``(E) 4 shall be individuals distinguished in the 
                fields of healthcare quality improvement, economics, 
                information systems, law, ethics, business, or public 
                policy, including at least 1 individual specializing in 
                rural aspects in 1 or more of these fields; and
                    ``(F) 2 shall be individuals representing the 
                interests of patients and consumers of healthcare.
            ``(3) Ex officio members.--The Secretary shall designate as 
        ex officio members of the Advisory Council--
                    ``(A) the Assistant Secretary for Health, the 
                Director of the National Institutes of Health, the 
                Director of the Centers for Disease Control and 
                Prevention, the Administrator of the Health Care 
                Financing Administration, the Assistant Secretary of 
                Defense (Health Affairs), and the Under Secretary for 
                Health of the Department of Veterans Affairs; and
                    ``(B) such other Federal officials as the Secretary 
                may consider appropriate.
    ``(d) Terms.--Members of the Advisory Council appointed under 
subsection (c)(2) shall serve for a term of 3 years. A member of the 
Council appointed under such subsection may continue to serve after the 
expiration of the term of the members until a successor is appointed.
    ``(e) Vacancies.--If a member of the Advisory Council appointed 
under subsection (c)(2) does not serve the full term applicable under 
subsection (d), the individual appointed to fill the resulting vacancy 
shall be appointed for the remainder of the term of the predecessor of 
the individual.
    ``(f) Chair.--The Director shall, from among the members of the 
Advisory Council appointed under subsection (c)(2), designate an 
individual to serve as the chair of the Advisory Council.
    ``(g) Meetings.--The Advisory Council shall meet not less than once 
during each discrete 4-month period and shall otherwise meet at the 
call of the Director or the chair.
    ``(h) Compensation and Reimbursement of Expenses.--
            ``(1) Appointed members.--Members of the Advisory Council 
        appointed under subsection (c)(2) shall receive compensation 
        for each day (including travel time) engaged in carrying out 
        the duties of the Advisory Council unless declined by the 
        member. Such compensation may not be in an amount in excess of 
        the daily equivalent of the annual rate of basic pay prescribed 
        for level IV of the Executive Schedule under section 5315 of 
        title 5, United States Code, for each day during which such 
        member is engaged in the performance of the duties of the 
        Advisory Council.
            ``(2) Ex officio members.--Officials designated under 
        subsection (c)(3) as ex officio members of the Advisory Council 
        may not receive compensation for service on the Advisory 
        Council in addition to the compensation otherwise received for 
        duties carried out as officers of the United States.
    ``(i) Staff.--The Director shall provide to the Advisory Council 
such staff, information, and other assistance as may be necessary to 
carry out the duties of the Council.

``SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS.

    ``(a) Requirement of Review.--
            ``(1) In general.--Appropriate technical and scientific 
        peer review shall be conducted with respect to each application 
        for a grant, cooperative agreement, or contract under this 
        title.
            ``(2) Reports to director.--Each peer review group to which 
        an application is submitted pursuant to paragraph (1) shall 
        report its finding and recommendations respecting the 
        application to the Director in such form and in such manner as 
        the Director shall require.
    ``(b) Approval as Precondition of Awards.--The Director may not 
approve an application described in subsection (a)(1) unless the 
application is recommended for approval by a peer review group 
established under subsection (c).
    ``(c) Establishment of Peer Review Groups.--
            ``(1) In general.--The Director shall establish such 
        technical and scientific peer review groups as may be necessary 
        to carry out this section. Such groups shall be established 
        without regard to the provisions of title 5, United States 
        Code, that govern appointments in the competitive service, and 
        without regard to the provisions of chapter 51, and subchapter 
        III of chapter 53, of such title that relate to classification 
        and pay rates under the General Schedule.
            ``(2) Membership.--The members of any peer review group 
        established under this section shall be appointed from among 
        individuals who by virtue of their training or experience are 
        eminently qualified to carry out the duties of such peer review 
        group. Officers and employees of the United States may not 
        constitute more than 25 percent of the membership of any such 
        group. Such officers and employees may not receive compensation 
        for service on such groups in addition to the compensation 
        otherwise received for these duties carried out as such 
        officers and employees.
            ``(3) Duration.--Notwithstanding section 14(a) of the 
        Federal Advisory Committee Act, peer review groups established 
        under this section may continue in existence until otherwise 
        provided by law.
            ``(4) Qualifications.--Members of any peer-review group 
        shall, at a minimum, meet the following requirements:
                    ``(A) Such members shall agree in writing to treat 
                information received, pursuant to their work for the 
                group, as confidential information, except that this 
                subparagraph shall not apply to public records and 
                public information.
                    ``(B) Such members shall agree in writing to recuse 
                themselves from participation in the peer-review of 
                specific applications which present a potential 
                personal conflict of interest or appearance of such 
                conflict, including employment in a directly affected 
                organization, stock ownership, or any financial or 
                other arrangement that might introduce bias in the 
                process of peer-review.
    ``(d) Authority for Procedural Adjustments in Certain Cases.--In 
the case of applications for financial assistance whose direct costs 
will not exceed $100,000, the Director may make appropriate adjustments 
in the procedures otherwise established by the Director for the conduct 
of peer review under this section. Such adjustments may be made for the 
purpose of encouraging the entry of individuals into the field of 
research, for the purpose of encouraging clinical practice-oriented or 
provider-based research, and for such other purposes as the Director 
may determine to be appropriate.
    ``(e) Regulations.--The Director shall issue regulations for the 
conduct of peer review under this section.

``SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, COLLECTION, 
              AND DISSEMINATION OF DATA.

    ``(a) Standards With Respect to Utility of Data.--
            ``(1) In general.--To ensure the utility, accuracy, and 
        sufficiency of data collected by or for the Agency for the 
        purpose described in section 901(b), the Director shall 
        establish standard methods for developing and collecting such 
        data, taking into consideration--
                    ``(A) other Federal health data collection 
                standards; and
                    ``(B) the differences between types of healthcare 
                plans, delivery systems, healthcare providers, and 
                provider arrangements.
            ``(2) Relationship with other department programs.--In any 
        case where standards under paragraph (1) may affect the 
        administration of other programs carried out by the Department 
        of Health and Human Services, including the programs under 
        title XVIII, XIX or XXI of the Social Security Act, or may 
        affect health information that is subject to a standard 
        developed under part C of title XI of the Social Security Act, 
        they shall be in the form of recommendations to the Secretary 
        for such program.
    ``(b) Statistics and Analyses.--The Director shall--
            ``(1) take appropriate action to ensure that statistics and 
        analyses developed under this title are of high quality, 
        timely, and duly comprehensive, and that the statistics are 
        specific, standardized, and adequately analyzed and indexed; 
        and
            ``(2) publish, make available, and disseminate such 
        statistics and analyses on as wide a basis as is practicable.
    ``(c) Authority Regarding Certain Requests.--Upon request of a 
public or private entity, the Director may conduct or support research 
or analyses otherwise authorized by this title pursuant to arrangements 
under which such entity will pay the cost of the services provided. 
Amounts received by the Director under such arrangements shall be 
available to the Director for obligation until expended.

``SEC. 924. DISSEMINATION OF INFORMATION.

    ``(a) In General.--The Director shall--
            ``(1) without regard to section 501 of title 44, United 
        States Code, promptly publish, make available, and otherwise 
        disseminate, in a form understandable and on as broad a basis 
        as practicable so as to maximize its use, the results of 
        research, demonstration projects, and evaluations conducted or 
        supported under this title;
            ``(2) ensure that information disseminated by the Agency is 
        science-based and objective and undertakes consultation as 
        necessary to assess the appropriateness and usefulness of the 
        presentation of information that is targeted to specific 
        audiences;
            ``(3) promptly make available to the public data developed 
        in such research, demonstration projects, and evaluations;
            ``(4) provide, in collaboration with the National Library 
        of Medicine where appropriate, indexing, abstracting, 
        translating, publishing, and other services leading to a more 
        effective and timely dissemination of information on research, 
        demonstration projects, and evaluations with respect to 
        healthcare to public and private entities and individuals 
        engaged in the improvement of healthcare delivery and the 
        general public, and undertake programs to develop new or 
        improved methods for making such information available; and
            ``(5) as appropriate, provide technical assistance to State 
        and local government and health agencies and conduct liaison 
        activities to such agencies to foster dissemination.
    ``(b) Prohibition Against Restrictions.--Except as provided in 
subsection (c), the Director may not restrict the publication or 
dissemination of data from, or the results of, projects conducted or 
supported under this title.
    ``(c) Limitation on Use of Certain Information.--No information, if 
an establishment or person supplying the information or described in it 
is identifiable, obtained in the course of activities undertaken or 
supported under this title may be used for any purpose other than the 
purpose for which it was supplied unless such establishment or person 
has consented (as determined under regulations of the Director) to its 
use for such other purpose. Such information may not be published or 
released in other form if the person who supplied the information or 
who is described in it is identifiable unless such person has consented 
(as determined under regulations of the Director) to its publication or 
release in other form.
    ``(d) Penalty.--Any person who violates subsection (c) shall be 
subject to a civil monetary penalty of not more than $10,000 for each 
such violation involved. Such penalty shall be imposed and collected in 
the same manner as civil money penalties under subsection (a) of 
section 1128A of the Social Security Act are imposed and collected.

``SEC. 925. ADDITIONAL PROVISIONS WITH RESPECT TO GRANTS AND CONTRACTS.

    ``(a) Financial Conflicts of Interest.--With respect to projects 
for which awards of grants, cooperative agreements, or contracts are 
authorized to be made under this title, the Director shall by 
regulation define--
            ``(1) the specific circumstances that constitute financial 
        interests in such projects that will, or may be reasonably 
        expected to, create a bias in favor of obtaining results in the 
        projects that are consistent with such interests; and
            ``(2) the actions that will be taken by the Director in 
        response to any such interests identified by the Director.
    ``(b) Requirement of Application.--The Director may not, with 
respect to any program under this title authorizing the provision of 
grants, cooperative agreements, or contracts, provide any such 
financial assistance unless an application for the assistance is 
submitted to the Secretary and the application is in such form, is made 
in such manner, and contains such agreements, assurances, and 
information as the Director determines to be necessary to carry out the 
program in involved.
    ``(c) Provision of Supplies and Services in Lieu of Funds.--
            ``(1) In general.--Upon the request of an entity receiving 
        a grant, cooperative agreement, or contract under this title, 
        the Secretary may, subject to paragraph (2), provide supplies, 
        equipment, and services for the purpose of aiding the entity in 
        carrying out the project involved and, for such purpose, may 
        detail to the entity any officer or employee of the Department 
        of Health and Human Services.
            ``(2) Corresponding reduction in funds.--With respect to a 
        request described in paragraph (1), the Secretary shall reduce 
        the amount of the financial assistance involved by an amount 
        equal to the costs of detailing personnel and the fair market 
        value of any supplies, equipment, or services provided by the 
        Director. The Secretary shall, for the payment of expenses 
        incurred in complying with such request, expend the amounts 
        withheld.
    ``(d) Applicability of Certain Provisions With Respect to 
Contracts.--Contracts may be entered into under this part without 
regard to sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 
529; 41 U.S.C. 5).

``SEC. 926. CERTAIN ADMINISTRATIVE AUTHORITIES.

    ``(a) Deputy Director and Other Officers and Employees.--
            ``(1) Deputy director.--The Director may appoint a deputy 
        director for the Agency.
            ``(2) Other officers and employees.--The Director may 
        appoint and fix the compensation of such officers and employees 
        as may be necessary to carry out this title. Except as 
        otherwise provided by law, such officers and employees shall be 
        appointed in accordance with the civil service laws and their 
        compensation fixed in accordance with title 5, United States 
        Code.
    ``(b) Facilities.--The Secretary, in carrying out this title--
            ``(1) may acquire, without regard to the Act of March 3, 
        1877 (40 U.S.C. 34), by lease or otherwise through the Director 
        of General Services, buildings or portions of buildings in the 
        District of Columbia or communities located adjacent to the 
        District of Columbia for use for a period not to exceed 10 
        years; and
            ``(2) may acquire, construct, improve, repair, operate, and 
        maintain laboratory, research, and other necessary facilities 
        and equipment, and such other real or personal property 
        (including patents) as the Secretary deems necessary.
    ``(c) Provision of Financial Assistance.--The Director, in carrying 
out this title, may make grants to public and nonprofit entities and 
individuals, and may enter into cooperative agreements or contracts 
with public and private entities and individuals.
    ``(d) Utilization of Certain Personnel and Resources.--
            ``(1) Department of health and human services.--The 
        Director, in carrying out this title, may utilize personnel and 
        equipment, facilities, and other physical resources of the 
        Department of Health and Human Services, permit appropriate (as 
        determined by the Secretary) entities and individuals to 
utilize the physical resources of such Department, and provide 
technical assistance and advice.
            ``(2) Other agencies.--The Director, in carrying out this 
        title, may use, with their consent, the services, equipment, 
        personnel, information, and facilities of other Federal, State, 
        or local public agencies, or of any foreign government, with or 
        without reimbursement of such agencies.
    ``(e) Consultants.--The Secretary, in carrying out this title, may 
secure, from time to time and for such periods as the Director deems 
advisable but in accordance with section 3109 of title 5, United States 
Code, the assistance and advice of consultants from the United States 
or abroad.
    ``(f) Experts.--
            ``(1) In general.--The Secretary may, in carrying out this 
        title, obtain the services of not more than 50 experts or 
        consultants who have appropriate scientific or professional 
        qualifications. Such experts or consultants shall be obtained 
        in accordance with section 3109 of title 5, United States Code, 
        except that the limitation in such section on the duration of 
        service shall not apply.
            ``(2) Travel expenses.--
                    ``(A) In general.--Experts and consultants whose 
                services are obtained under paragraph (1) shall be paid 
                or reimbursed for their expenses associated with 
                traveling to and from their assignment location in 
                accordance with sections 5724, 5724a(a), 5724a(c), and 
                5726(C) of title 5, United States Code.
                    ``(B) Limitation.--Expenses specified in 
                subparagraph (A) may not be allowed in connection with 
                the assignment of an expert or consultant whose 
                services are obtained under paragraph (1) unless and 
                until the expert agrees in writing to complete the 
entire period of assignment, or 1 year, whichever is shorter, unless 
separated or reassigned for reasons that are beyond the control of the 
expert or consultant and that are acceptable to the Secretary. If the 
expert or consultant violates the agreement, the money spent by the 
United States for the expenses specified in subparagraph (A) is 
recoverable from the expert or consultant as a statutory obligation 
owed to the United States. The Secretary may waive in whole or in part 
a right of recovery under this subparagraph.
    ``(g) Voluntary and Uncompensated Services.--The Director, in 
carrying out this title, may accept voluntary and uncompensated 
services.

``SEC. 927. FUNDING.

    ``(a) Intent.--To ensure that the United States's investment in 
biomedical research is rapidly translated into improvements in the 
quality of patient care, there must be a corresponding investment in 
research on the most effective clinical and organizational strategies 
for use of these findings in daily practice. The authorization levels 
in subsection (b) provide for a proportionate increase in healthcare 
research as the United States investment in biomedical research 
increases.
    ``(b) Authorization of Appropriations.--For the purpose of carrying 
out this title, there are authorized to be appropriated $250,000,000 
for fiscal year 2000, and such sums as may be necessary for each of the 
fiscal years 2001 through 2006.
    ``(c) Evaluations.--In addition to amounts available pursuant to 
subsection (b) for carrying out this title, there shall be made 
available for such purpose, from the amounts made available pursuant to 
section 241 (relating to evaluations), an amount equal to 40 percent of 
the maximum amount authorized in such section 241 to be made available 
for a fiscal year.

``SEC. 928. DEFINITIONS.

    ``In this title:
            ``(1) Advisory council.--The term `Advisory Council' means 
        the Advisory Council on Healthcare Research and Quality 
        established under section 921.
            ``(2) Agency.--The term `Agency' means the Agency for 
        Healthcare Research and Quality.
            ``(3) Director.--The term `Director' means the Director for 
        the Agency for Healthcare Research and Quality.''.

SEC. 303. REFERENCES.

    Effective upon the date of enactment of this Act, any reference in 
law to the ``Agency for Health Care Policy and Research'' shall be 
deemed to be a reference to the ``Agency for Healthcare Research and 
Quality''.

                   TITLE IV--MISCELLANEOUS PROVISIONS

SEC. 401. SENSE OF THE COMMITTEE.

    It is the sense of the Committee on Health, Education, Labor, and 
Pensions of the Senate that the Congress should take measures to 
further the purposes of this Act, including any necessary changes to 
the Internal Revenue Code of 1986 or to other Acts to--
            (1) promote equity and prohibit discrimination based on 
        genetic information with respect to the availability of health 
        benefits;
            (2) provide for the full deduction of health insurance 
        costs for self-employed individuals;
            (3) provide for the full availability of medical savings 
        accounts;
            (4) provide for the carryover of unused benefits from 
        cafeteria plans, flexible spending arrangements, and health 
        flexible spending accounts; and
            (5) permit contributions towards medical savings account 
        through the Federal employees health benefits program.
```