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

  1st Session
                                 S. 326

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 28, 1999

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

_______________________________________________________________________

                                 A BILL


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

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

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. Continuity of care.
        ``Sec. 726. Protection of patient-provider communications.
        ``Sec. 727. Generally applicable provision.''
Sec. 102. Effective date and related rules.
       Subtitle B--Right to Information About Plans and Providers

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

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

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

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

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

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

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

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

               ``Part A--Establishment and General Duties

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

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

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

Sec. 501. Sense of the Committee.

                   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. 1185 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 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.--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.
    ``(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)) 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--
                    ``(A) a choice of health insurance coverage through 
                more than one health insurance issuer; or
                    ``(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.
    ``(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) In General.--In any case in which a group health plan (other 
than a fully insured group health plan)--
            ``(1) provides coverage for benefits consisting of--
                    ``(A) gynecological care (such as preventive 
                women's health examinations); or
                    ``(B) obstetric care (such as pregnancy-related 
                services);
        provided by a participating physician who specializes in such 
        care; and
            ``(2) requires or provides for designation by a participant 
        or beneficiary of a participating primary care provider;
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).
    ``(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--
            ``(1) does not require authorization or a referral by the 
        primary care provider in order to obtain coverage for such 
        benefits, and
            ``(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.
    ``(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.

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

    ``(a) In General.--In any case in which a group health plan (other 
than a fully insured group health plan)--
            ``(1) provides coverage for benefits consisting of 
        pediatric care by a participating pediatrician; and
            ``(2) requires or provides for designation by a participant 
        or beneficiary of a participating primary care provider;
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).
    ``(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--
            ``(1) does not require authorization or a referral by the 
        primary care provider in order to obtain coverage for such 
        benefits, and
            ``(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.
    ``(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.

``SEC. 725. 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 extend 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)(B) 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, 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.
            ``(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. 726. 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. 727. GENERALLY APPLICABLE PROVISION.

    ``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.''.
    (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:
            ``(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.''.
    (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. Continuity of care.
``Sec. 726. Protection of patient-provider communications.
``Sec. 727. Generally applicable provisions.''.

SEC. 102. 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) 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.--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).
    ``(b) Required Information.--The informational materials to be 
distributed under this section shall include for each health benefit 
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.
            ``(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.
            ``(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 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.
            ``(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 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).
            ``(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 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.
            ``(10) A summary of the rules for access to emergency room 
        care. Also, any available educational material regarding proper 
        use of emergency services.
            ``(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.
            ``(12) A description of the specific preventative services 
        covered under the plan if such services are covered.
            ``(13) A statement regarding--
                    ``(A) the manner in which an enrollee may access an 
                obstetrician, gynecologist, or pediatrician in 
                accordance with section 723 or 724;
                    ``(B) the manner in which an enrollee obtains 
                continuity of care as provided for in section 725; and
                    ``(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.
            ``(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:
                    ``(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, and any provision 
                for obtaining off-formulary medications.
                    ``(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.--
            ``(1) In general.--The information described in this 
        section shall be distributed in an accessible format that is 
        understandable to an average plan enrollee.
            ``(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--
                    ``(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
                    ``(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.
    ``(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.
    ``(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.''.
    (b) Conforming Amendments.--
            (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''.
            (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:

        ``Sec. 714. Health plan comparative information.''.

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 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;
                            ``(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
                            ``(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.
                    ``(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 after a request is 
                        received by the plan or issuer under clause 
                        (ii) or (iii).
                            ``(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.
                            ``(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.
                    ``(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 all 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 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.
                    ``(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).
                    ``(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.
                    ``(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.
                    ``(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--
                            ``(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;
                            ``(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 and enrollees. Determinations under such procedures shall be non-
appealable.
    ``(d) Internal Appeal of Coverage Determinations.--
            ``(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.
            ``(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.
            ``(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.
            ``(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 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.
                    ``(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.
            ``(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.
            ``(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.
            ``(7) Notice.--
                    ``(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).
                    ``(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 enrollee;
                            ``(ii) the procedures for obtaining 
                        additional information concerning the 
                        determination; and
                            ``(iii) notification of the right to an 
                        external review under subsection (e) and 
                        instructions on how to initiate such a review.
    ``(e) External Review.--
            ``(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--
                    ``(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;
                    ``(B) the coverage determination involved denied 
                coverage for such item or service because the provision 
                of such item or service--
                            ``(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
                            ``(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
                    ``(C) the enrollee has completed the internal 
                appeals process with respect to such determination.
            ``(2) Initiation of the external review process.--
                    ``(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.
                    ``(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).
                    ``(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).
                    ``(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.
            ``(3) Conduct of external review.--
                    ``(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:
                            ``(i) An 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 external review 
                        services.
                            ``(iv) Any entity accredited as an external 
                        review entity by an accrediting body recognized 
                        by the Secretary for such purpose.
                            ``(v) Any fully accredited teaching 
                        hospital.
                            ``(vi) Any other entity meeting criteria 
                        established by the Secretary for purposes of 
                        this subparagraph.
                    ``(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--
                            ``(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 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;
                            ``(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;
                            ``(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
                            ``(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 external reviewer shall--
                            ``(i) make a determination based on the 
                        medical necessity, appropriateness, 
                        experimental or investigational nature of the 
                        coverage denial;
                            ``(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
                            ``(iii) submit a report on the final 
                        determinations of the review involved to--
                                    ``(I) the plan or issuer involved;
                                    ``(II) the enrollee involved (or 
                                the legal representative of the 
                                enrollee); and
                                    ``(III) the health care 
                                professional involved.
                    ``(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.
            ``(5) Timeframe for review.--
                    ``(A) In general.--An 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 
        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.
            ``(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.
            ``(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 external review by an 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) Enrollee.--The term enrollee means a participant or 
        beneficiary.
            ``(4) Grievance.--The term `grievance' means any enrollee 
        complaint that does not involve a coverage determination.
            ``(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.
            ``(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.
            ``(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.
            ``(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.
            ``(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.
            ``(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.''
    (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--INDIVIDUAL RIGHTS WITH RESPECT TO PERSONAL MEDICAL 
                              INFORMATION

SEC. 201. SHORT TITLE.

    This title may be cited as the ``Personal Medical Information 
Access Act''.

                 Subtitle A--Access to Medical Records

SEC. 211. INSPECTION AND COPYING OF PROTECTED HEALTH INFORMATION.

    (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.
    (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:
            (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.
            (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.
            (3) Information compiled in anticipation of litigation.--
        The information is compiled principally--
                    (A) in the reasonable anticipation of a civil, 
                criminal, or administrative action or proceeding; or
                    (B) for use in such an action or proceeding.
            (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.
    (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--
            (1) the reasons for the denial of the request for 
        inspection or copying;
            (2) any procedures for further review of the denial; and
            (3) the individual's right to file with the entity a 
        concise statement setting forth the request for inspection or 
        copying.
    (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--
            (1) a copy of the individual's statement; and
            (2) a concise statement of the reasons for denying the 
        request for inspection or copying.
    (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).
    (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.
    (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--
            (1) the protected health information is retained by the 
        agent; and
            (2) the agent has received in writing a request from the 
        entity involved to fulfill the requirements of this section;
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.
    (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.

SEC. 212. AMENDMENT OF PROTECTED HEALTH INFORMATION.

    (a) Requirement.--
            (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--
                    (A) amend such information as requested;
                    (B) inform the individual of the amendment that has 
                been made; and
                    (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.
            (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--
                    (A) created the protected health information 
                involved; and
                    (B) determines that such information is in fact 
                inaccurate.
    (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--
            (1) the reasons for the refusal to make the amendment;
            (2) any procedures for further review of the refusal; and
            (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.
    (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--
            (1) shall include a copy of the individual's statement; and
            (2) may include a concise statement of the reasons for not 
        making the requested amendment.
    (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--
            (1) the protected health information is retained by the 
        agent; and
            (2) the agent has been asked by such entity to fulfill the 
        requirements of this section.
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).
    (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.
    (f) Rules of Construction.--This section shall not be construed 
to--
            (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;
            (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
            (3) permit any deletions or alterations of the original 
        information.

SEC. 213. NOTICE OF CONFIDENTIALITY PRACTICES.

    (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--
            (1) a description of an individual's rights with respect to 
        protected health information;
            (2) the procedures established by the entity for the 
        exercise of the individual's rights; and
            (3) the right to obtain a copy of the notice of the 
        confidentiality practices required under this subtitle.
    (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.

                Subtitle B--Establishment of Safeguards

SEC. 221. ESTABLISHMENT OF SAFEGUARDS.

    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.

                  Subtitle C--Enforcement; Definitions

SEC. 231. CIVIL PENALTY.

    (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.
    (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.

SEC. 232. DEFINITIONS.

    In this title:
            (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.
            (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.
            (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.
            (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--
                    (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;
                    (B) a Federal, State, or employer-sponsored program 
                that directly provides items or services that 
                constitute health care to beneficiaries; or
                    (C) an officer, employee, or agent of a person 
                described in subparagraph (A) or (B).
            (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.
            (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.
            (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.
            (8) Protected health information.--The term ``protected 
        health information'' means any information (including 
        demographic information) whether or not recorded in any form or 
        medium--
                    (A) that relates to the past, present or future--
                            (i) physical or mental health or condition 
                        of an individual (including the condition or 
                        other attributes of individual cells or their 
                        components);
                            (ii) provision of health care to an 
                        individual; or
                            (iii) payment for the provision of health 
                        care to an individual;
                    (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
                    (C) that is not nonidentifiable health information.
            (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.
            (10) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (11) Writing.--The term ``writing'' means writing in either 
        a paper-based or computer-based form, including electronic 
        signatures.

SEC. 233. EFFECTIVE DATE.

    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.

              TITLE III--GENETIC INFORMATION AND SERVICES

SEC. 301. SHORT TITLE.

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

SEC. 302. 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 
        (29 U.S.C. 1185 et seq.) (as amended by section 111) is further 
        amended by adding at the end the following:

``SEC. 714. 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 an individual in the group or 
a family member of the individual (including information about a 
request for or receipt of genetic services).''.
            (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:
            ``(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.''.
    (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 an individual 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 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.
                    ``(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.''.
    (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--
                            ``(i) information about an individual's 
                        genetic tests which are associated with a 
                        statistically significant increased risk of 
                        developing a disease or disorder;
                            ``(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 that 
                        predicts a statistically significant increased 
                        risk of a disease or disorder in the 
                        individual.
                    ``(B) Exceptions.--The term `predictive genetic 
                information' shall not include--
                            ``(i) information about the sex or age of 
                        the individual;
                            ``(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
                            ``(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).
            ``(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.''.
    (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. 303. 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) 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:

``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 an individual in the group or 
a family member of the individual (including information about a 
request for or receipt of genetic services).''.
                    (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:
            ``(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.''.
                    (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:
    ``(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 an individual 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 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.
                    ``(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.''.
            (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.
            ``(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--
                            ``(i) information about an individual's 
                        genetic tests which is associated with a 
                        statistically significant increased risk of 
                        developing a disease or disorder;
                            ``(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 that 
                        predicts a statistically significant increased 
                        risk of a disease or disorder in the 
                        individual.
                    ``(B) Exceptions.--The term `predictive genetic 
                information' shall not include--
                            ``(i) information about the sex or age of 
                        the individual;
                            ``(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
                            ``(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).
            ``(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.''.
    (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--
            (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 enrollee or a family member of the enrollee (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 an individual 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 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 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.''.
    (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.

               TITLE IV--HEALTHCARE RESEARCH AND QUALITY

SEC. 401. SHORT TITLE.

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

SEC. 402. 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 practice, 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 primary, acute 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--
            ``(1) the delivery of health services in rural areas 
        (including frontier areas);
            ``(2) health services for low-income groups, and minority 
        groups;
            ``(3) the health of children;
            ``(4) the elderly; and
            ``(5) 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.
            ``(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 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.
    ``(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 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.
    ``(b) Healthcare Improvement Research Centers and Provider-Based 
Research Networks.--
            ``(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--
                    ``(A) Healthcare Improvement Research Centers that 
                combine demonstrated multidisciplinary expertise in 
                outcomes or quality improvement research with linkages 
                to relevant sites of care;
                    ``(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
                    ``(C) other innovative mechanisms or strategies to 
                link research with clinical practice.
            ``(2) Requirements.--The Director is authorized to 
        establish the requirements for entities applying for grants 
        under this subsection.

``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--
                            ``(i) methods for the evaluation of the 
                        health of 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 
                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 a grant may 
                not be expended to assist the Secretary in the 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) 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;
            ``(2) develop databases and tools that enable States to 
        track the quality, access, and use of healthcare services 
        provided to their residents; and
            ``(3) enter into agreements with public or private entities 
        to use, link, or acquire databases for research authorized 
        under this title.
    ``(b) Quality and Outcomes Information.--
            ``(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--
                    ``(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
                    ``(B) 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 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.
            ``(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.

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

    ``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 structure, content, definition, and coding of 
        health information data and medical vocabularies in 
        consultation with appropriate Federal and private entities;
            ``(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
            ``(7) the protection of individually identifiable 
        information in health services research and healthcare quality 
        improvement.

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

    ``(a) Preventive Services Task Force.--
            ``(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.
            ``(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.
    ``(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 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 on--
                    ``(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.
            ``(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.

``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 methods 
        used by the Agency and its contractors for practice and 
        technology assessment.
            ``(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.
            ``(3) Methodology.--The methods employed in practice and 
        technology assessments under paragraph (1) shall consider--
                    ``(A) safety, efficacy, and effectiveness;
                    ``(B) legal, social, and ethical implications;
                    ``(C) costs, benefits, and cost-effectiveness;
                    ``(D) comparisons to alternative 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, professional organizations, third party payers, 
        other 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 and quality measurement and 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 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 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--
                    ``(A) to describe and evaluate current quality 
                improvement research and monitoring processes through--
                            ``(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;
                            ``(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;
                            ``(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
                            ``(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
                    ``(B) to identify options and make recommendations 
                to improve the efficiency and effectiveness of such 
                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 various 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; 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 Chief Medical Officer 
                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 maximum rate of basic pay payable for GS-18 of the General 
        Schedule.
            ``(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 may 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 standards and 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 
        titles XVIII, XIX and XXI 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 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.
    ``(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 subsections (b) and (c) provide for a proportionate increase in 
healthcare research as the United State's investment in biomedical 
research increases.
    ``(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.
    ``(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. 929. 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. 403. 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''.

SEC. 404. STUDY.

    (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--
            (1) the safety and efficacy of the benefit, particularly 
        the effect of the benefit on outcomes of care;
            (2) the cost, benefits and value of such benefit;
            (3) the benefit in comparison to alternative approaches in 
        improving care; and
            (4) the overall impact that such benefit will have on 
        health care as measured through research.
    (b) Qualifying Health Care Benefit.--In this section, the term 
``qualifying health care benefit'' means a health care benefit that--
            (1) is disease- or health condition-specific;
            (2) requires the provision of or coverage for health care 
        items or services;
            (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
            (4) was provided under an Act (or amendment) enacted on or 
        after January 1, 1999.
    (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.

                   TITLE V--MISCELLANEOUS PROVISIONS

SEC. 501. 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.
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