[Congressional Record (Bound Edition), Volume 145 (1999), Part 11]
[Senate]
[Pages 15517-15536]
[From the U.S. Government Publishing Office, www.gpo.gov]




                          AMENDMENTS SUBMITTED

                                 ______
                                 

                      PATIENTS' BILL OF RIGHTS ACT

                                 ______
                                 

                       DASCHLE AMENDMENT NO. 1232

  Mr. DASCHLE proposed an amendment to the bill (S. 1344) to amend the 
Public Health Service Act, the Employee Retirement Income Security Act 
of 1974, and the Internal Revenue Code of 1986 to protect consumers in 
managed care plans and other health coverage; as follows:

       Strike all after the enacting clause and insert the 
     following:

     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. Patient right to medical advice and care.


         ``SUBPART C--PATIENT RIGHT TO MEDICAL ADVICE AND CARE

``Sec. 721. Patient access to emergency medical care.
``Sec. 722. Offering of choice of coverage options.

[[Page 15518]]

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

       Subtitle B--Right to Information About Plans and Providers

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

           Subtitle C--Right to Hold Health Plans Accountable

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

               TITLE II--GENETIC INFORMATION AND SERVICES

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

               TITLE III--HEALTHCARE RESEARCH AND QUALITY

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

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

               ``Part A--Establishment and General Duties

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

               ``Part B--Healthcare Improvement Research

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

                      ``Part C--General Provisions

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

                   TITLE IV--MISCELLANEOUS PROVISIONS

Sec. 401. Sense of the Committee.

                   TITLE I--PATIENTS' BILL OF RIGHTS

                  Subtitle A--Right to Advice and Care

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

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

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

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

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

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

       ``(a) Requirement.--
       ``(1) Offering of point-of-service coverage option.--Except 
     as provided in paragraph (2), if a group health plan (other 
     than a fully insured group health plan) provides coverage for 
     benefits only through a defined set of participating health 
     care professionals, the plan shall offer the participant the 
     option to purchase point-of-service coverage (as defined in 
     subsection (b)) for all such benefits for which coverage is 
     otherwise so limited. Such option shall be made available to 
     the participant at the time of enrollment under the plan and 
     at such other times as the plan offers the participant a 
     choice of coverage options.
       ``(2) Exception in the case of multiple issuer or coverage 
     options.--Paragraph (1) shall not apply with respect to a 
     participant in a group health plan (other than a fully 
     insured group health plan) if the plan offers the participant 
     2 or more coverage options that differ significantly with 
     respect to the use of participating health care professionals 
     or the networks of such professionals that are used.
       ``(b) Point-of-Service Coverage Defined.--In this section, 
     the term `point-of-service coverage' means, with respect to 
     benefits covered under a group health plan (other than a 
     fully insured group health plan), coverage of such benefits 
     when provided by a nonparticipating health care professional.
       ``(c) Small Employer Exemption.--
       ``(1) In general.--This section shall not apply to any 
     group health plan (other than a fully insured group health 
     plan) of a small employer.
       ``(2) Small employer.--For purposes of paragraph (1), the 
     term `small employer' means, in connection with a group 
     health plan (other than a fully insured group health plan) 
     with respect to a calendar year and a plan year, an employer 
     who employed an average of at least 2 but not more than 50 
     employees on business days during the preceding calendar year 
     and who employs at least 2 employees on the first day of the 
     plan year. For purposes of this paragraph, the provisions of 
     subparagraph (C) of section 712(c)(1) shall apply in 
     determining employer size.

[[Page 15519]]

       ``(d) Rule of Construction.--Nothing in this section shall 
     be construed--
       ``(1) as requiring coverage for benefits for a particular 
     type of health care professional;
       ``(2) as requiring an employer to pay any costs as a result 
     of this section or to make equal contributions with respect 
     to different health coverage options;
       ``(3) as preventing a group health plan (other than a fully 
     insured group health plan) from imposing higher premiums or 
     cost-sharing on a participant for the exercise of a point-of-
     service coverage option; or
       ``(4) to require that a group health plan (other than a 
     fully insured group health plan) include coverage of health 
     care professionals that the plan excludes because of fraud, 
     quality of care, or other similar reasons with respect to 
     such professionals.

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

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

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

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

     ``SEC. 725. ACCESS TO SPECIALISTS.

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

     ``SEC. 726. CONTINUITY OF CARE.

       ``(a) In General.--
       ``(1) Termination of provider.--If a contract between a 
     group health plan (other than a fully insured group health 
     plan) and a health care provider is terminated (as defined in 
     paragraph (2)), or benefits or coverage provided by a health 
     care provider are terminated because of a change in the terms 
     of provider participation in such group health plan, and an 
     individual who is a participant or beneficiary in the plan is 
     undergoing a course of treatment from the provider at the 
     time of such termination, the plan shall--
       ``(A) notify the individual on a timely basis of such 
     termination;
       ``(B) provide the individual with an opportunity to notify 
     the plan of a need for transitional care; and
       ``(C) in the case of termination described in paragraph 
     (2), (3), or (4) of subsection (b), and subject to subsection 
     (c), permit the individual to continue or be covered with 
     respect to the course of treatment with the provider's 
     consent during a transitional period (as provided under 
     subsection (b)).
       ``(2) Terminated.--In this section, the term `terminated' 
     includes, with respect to a contract, the expiration or 
     nonrenewal of the contract by the group health plan, but does 
     not include a termination of the contract by the plan for 
     failure to meet applicable quality standards or for fraud.
       ``(3) Contracts.--For purposes of this section, the term 
     `contract between a group health plan (other than a fully 
     insured group health plan) and a health care provider' shall 
     include a contract between such a plan and an organized 
     network of providers.
       ``(b) Transitional Period.--
       ``(1) General rule.--Except as provided in paragraph (3), 
     the transitional period under this subsection shall permit 
     the participant or beneficiary to extend the coverage 
     involved for up to 90 days from the date of the notice 
     described in subsection (a)(1)(A) of the provider's 
     termination.
       ``(2) Institutional care.--Subject to paragraph (1), the 
     transitional period under this subsection for institutional 
     or inpatient care from a provider shall extend until the 
     discharge or termination of the period of 
     institutionalization and also shall include institutional 
     care provided within a reasonable time of the date of 
     termination of the provider status if the care was scheduled 
     before the date of the announcement of the termination of the 
     provider status under subsection (a)(1)(A) or if the 
     individual on such date was on an established waiting list or 
     otherwise scheduled to have such care.
       ``(3) Pregnancy.--Notwithstanding paragraph (1), if--
       ``(A) a participant or beneficiary has entered the second 
     trimester of pregnancy at the time of a provider's 
     termination of participation; and
       ``(B) the provider was treating the pregnancy before the 
     date of the termination;

     the transitional period under this subsection with respect to 
     provider's treatment of the pregnancy shall extend through 
     the provision of post-partum care directly related to the 
     delivery.
       ``(4) Terminal illness.--Subject to paragraph (1), if--
       ``(A) a participant or beneficiary was determined to be 
     terminally ill (as determined under section 1861(dd)(3)(A) of 
     the Social Security Act) prior to a provider's termination of 
     participation; and
       ``(B) the provider was treating the terminal illness before 
     the date of termination;

     the transitional period under this subsection shall be for 
     care directly related to the treatment of the terminal 
     illness.
       ``(c) Permissible Terms and Conditions.--A group health 
     plan (other than a fully insured group health plan) may 
     condition coverage of continued treatment by a provider under 
     subsection (a)(1)(C) upon the provider agreeing to the 
     following terms and conditions:
       ``(1) The provider agrees to accept reimbursement from the 
     plan and individual involved (with respect to cost-sharing) 
     at the rates applicable prior to the start of the 
     transitional period as payment in full (or at the rates 
     applicable under the replacement plan after the date of the 
     termination of the contract with the group health plan) and 
     not to impose cost-sharing with respect to the individual in 
     an amount that would exceed

[[Page 15520]]

     the cost-sharing that could have been imposed if the contract 
     referred to in subsection (a)(1) had not been terminated.
       ``(2) The provider agrees to adhere to the quality 
     assurance standards of the plan responsible for payment under 
     paragraph (1) and to provide to such plan necessary medical 
     information related to the care provided.
       ``(3) The provider agrees otherwise to adhere to such 
     plan's policies and procedures, including procedures 
     regarding referrals and obtaining prior authorization and 
     providing services pursuant to a treatment plan (if any) 
     approved by the plan.
       ``(d) Rule of Construction.--Nothing in this section shall 
     be construed to require the coverage of benefits which would 
     not have been covered if the provider involved remained a 
     participating provider.
       ``(e) Definition.--In this section, the term `health care 
     provider' or `provider' means--
       ``(1) any individual who is engaged in the delivery of 
     health care services in a State and who is required by State 
     law or regulation to be licensed or certified by the State to 
     engage in the delivery of such services in the State; and
       ``(2) any entity that is engaged in the delivery of health 
     care services in a State and that, if it is required by State 
     law or regulation to be licensed or certified by the State to 
     engage in the delivery of such services in the State, is so 
     licensed.

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

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

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

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

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

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

     ``SEC. 730. GENERALLY APPLICABLE PROVISION.

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

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

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

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

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

     SEC. 103. EFFECTIVE DATE AND RELATED RULES.

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

       Subtitle B--Right to Information About Plans and Providers

     SEC. 111. INFORMATION ABOUT PLANS.

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

     ``SEC. 714. HEALTH PLAN COMPARATIVE INFORMATION.

       ``(a) Requirement.--
       ``(1) In general.--A group health plan, and a health 
     insurance issuer that provides coverage in connection with 
     group health insurance coverage, shall, not later than 12 
     months after the date of enactment of this section, and at 
     least annually thereafter, provide for the disclosure, in a 
     clear and accurate form to each participant and each 
     beneficiary who does not reside at the same address as the 
     participant, or upon request to an individual eligible for 
     coverage under the plan, of the information described in 
     subsection (b).
       ``(2) Rule of construction.--Nothing in this section shall 
     be construed to prevent a plan or issuer from entering into 
     any agreement under which the issuer agrees to assume 
     responsibility for compliance with the requirements of this 
     section and the plan is released from liability for such 
     compliance.

[[Page 15521]]

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

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

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

     ``SEC. 9813. HEALTH PLAN COMPARATIVE INFORMATION.

       ``(a) Requirement.--
       ``(1) In general.--A group health plan shall, not later 
     than 12 months after the date of enactment of this section, 
     and at least annually thereafter, provide for the disclosure, 
     in a clear and accurate form to each participant and each 
     beneficiary who does not reside at the same address as the 
     participant, or upon request to an individual eligible for 
     coverage under the plan, of the information described in 
     subsection (b).
       ``(2) Rules of construction.--Nothing in this section shall 
     be construed to prevent a plan from entering into any 
     agreement under which a health insurance issuer agrees to 
     assume responsibility for compliance with the requirements of 
     this section and the plan is released from liability for such 
     compliance.
       ``(3) Provision of information.--Information shall be 
     provided to participants and beneficiaries under this section 
     at the address maintained by the plan with respect to such 
     participants or beneficiaries.
       ``(b) Required Information.--The informational materials to 
     be distributed under this section shall include for each 
     package option available under a group health plan the 
     following:
       ``(1) A description of the covered items and services under 
     each such plan and any in- and out-of-network features of 
     each such plan, including a summary description of the 
     specific exclusions from coverage under the plan.
       ``(2) A description of any cost-sharing, including 
     premiums, deductibles, coinsurance, and copayment amounts, 
     for which the participant or beneficiary will be responsible, 
     including any annual or lifetime limits on benefits, for each 
     such plan.
       ``(3) A description of any optional supplemental benefits 
     offered by each such plan and the terms and conditions 
     (including premiums or cost-sharing) for such supplemental 
     coverage.
       ``(4) A description of any restrictions on payments for 
     services furnished to a participant or beneficiary by a 
     health care professional that is not a participating 
     professional and the liability of the participant or 
     beneficiary for additional payments for these services.

[[Page 15522]]

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

     SEC. 112. INFORMATION ABOUT PROVIDERS.

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

           Subtitle C--Right to Hold Health Plans Accountable

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

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

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

       ``(a) Claims Procedure.--In accordance with regulations of 
     the Secretary, every employee benefit plan shall--
       ``(1) provide adequate notice in writing to any participant 
     or beneficiary whose claim for benefits under the plan has 
     been denied, setting forth the specific reasons for such 
     denial, written in a manner calculated to be understood by 
     the participant; and
       ``(2) afford a reasonable opportunity to any participant 
     whose claim for benefits has been denied for a full and fair 
     review by the appropriate named fiduciary of the decision 
     denying the claim.
       ``(b) Coverage Determinations Under Group Health Plans.--
       ``(1) Procedures.--
       ``(A) In general.--A group health plan or health insurance 
     issuer conducting utilization review shall ensure that 
     procedures are in place for--
       ``(i) making determinations regarding whether a participant 
     or beneficiary is eligible to receive a payment or coverage 
     for health services under the plan or coverage involved and 
     any cost-sharing amount that the participant or beneficiary 
     is required to pay with respect to such service;
       ``(ii) notifying a covered participant or beneficiary (or 
     the authorized representative of such participant or 
     beneficiary) and the treating health care professionals 
     involved regarding determinations made under the plan or 
     issuer and any additional payments that the participant or 
     beneficiary may be required to make with respect to such 
     service; and
       ``(iii) responding to requests, either written or oral, for 
     coverage determinations or for internal appeals from a 
     participant or beneficiary (or the authorized representative 
     of such participant or beneficiary) or the treating health 
     care professional with the consent of the participant or 
     beneficiary.
       ``(B) Oral requests.--With respect to an oral request 
     described in subparagraph (A)(iii), a group health plan or 
     health insurance issuer may require that the requesting 
     individual provide written evidence of such request.
       ``(2) Timeline for making determinations.--
       ``(A) Routine determination.--A group health plan or a 
     health insurance issuer shall maintain procedures to ensure 
     that prior authorization determinations concerning the 
     provision of non-emergency items or services are made within 
     30 days from the date on which the request for a 
     determination is submitted, except that such period may be 
     extended where certain circumstances exist that are 
     determined by the Secretary to be beyond control of the plan 
     or issuer.
       ``(B) Expedited determination.--
       ``(i) In general.--A prior authorization determination 
     under this subsection shall be made within 72 hours, in 
     accordance with the medical exigencies of the case, after a 
     request is received by the plan or issuer under clause (ii) 
     or (iii).
       ``(ii) Request by participant or beneficiary.--A plan or 
     issuer shall maintain procedures for expediting a prior 
     authorization determination under this subsection upon the 
     request of a participant or beneficiary if, based on such a 
     request, the plan or issuer determines that the normal time 
     for making such a determination could seriously jeopardize 
     the life or health of the participant or beneficiary.
       ``(iii) Documentation by health care professional.--A plan 
     or issuer shall maintain

[[Page 15523]]

     procedures for expediting a prior authorization determination 
     under this subsection if the request involved indicates that 
     the treating health care professional has reasonably 
     documented, based on the medical exigencies, that a 
     determination under the procedures described in subparagraph 
     (A) could seriously jeopardize the life or health of the 
     participant or beneficiary.
       ``(C) Concurrent determinations.--A plan or issuer shall 
     maintain procedures to certify or deny coverage of an 
     extended stay or additional services.
       ``(D) Retrospective determination.--A plan or issuer shall 
     maintain procedures to ensure that, with respect to the 
     retrospective review of a determination made under paragraph 
     (1), the determination shall be made within 30 working days 
     of the date on which the plan or issuer receives necessary 
     information.
       ``(3) Notice of determinations.--
       ``(A) Routine determination.--With respect to a coverage 
     determination of a plan or issuer under paragraph (2)(A), the 
     plan or issuer shall issue notice of such determination to 
     the participant or beneficiary (or the authorized 
     representative of the participant or beneficiary) and, 
     consistent with the medical exigencies of the case, to the 
     treating health care professional involved not later than 2 
     working days after the date on which the determination is 
     made.
       ``(B) Expedited determination.--With respect to a coverage 
     determination of a plan or issuer under paragraph (2)(B), the 
     plan or issuer shall issue notice of such determination to 
     the participant or beneficiary (or the authorized 
     representative of the participant or beneficiary), and 
     consistent with the medical exigencies of the case, to the 
     treating health care professional involved within the 72 hour 
     period described in paragraph (2)(B).
       ``(C) Concurrent reviews.--With respect to the 
     determination under a plan or issuer under paragraph (2)(C) 
     to certify or deny coverage of an extended stay or additional 
     services, the plan or issuer shall issue notice of such 
     determination to the treating health care professional and to 
     the participant or beneficiary involved (or the authorized 
     representative of the participant or beneficiary) within 1 
     working day of the determination.
       ``(D) Retrospective reviews.--With respect to the 
     retrospective review under a plan or issuer of a 
     determination made under paragraph (2)(D), the plan or issuer 
     shall issue written notice of an approval or disapproval of a 
     determination under this subparagraph to the participant or 
     beneficiary (or the authorized representative of the 
     participant or beneficiary) and health care provider involved 
     within 5 working days of the date on which such determination 
     is made.
       ``(E) Requirements of notice of adverse coverage 
     determinations.--A written notice of an adverse coverage 
     determination under this subsection, or of an expedited 
     adverse coverage determination under paragraph (2)(B), shall 
     be provided to the participant or beneficiary (or the 
     authorized representative of the participant or beneficiary) 
     and treating health care professional (if any) involved and 
     shall include--
       ``(i) the reasons for the determination (including the 
     clinical or scientific-evidence based rationale used in 
     making the determination) written in a manner to be 
     understandable to the average participant or beneficiary;
       ``(ii) the procedures for obtaining additional information 
     concerning the determination; and
       ``(iii) notification of the right to appeal the 
     determination and instructions on how to initiate an appeal 
     in accordance with subsection (d).
       ``(c) Grievances.--A group health plan or a health 
     insurance issuer shall have written procedures for addressing 
     grievances between the plan or issuer offering health 
     insurance coverage in connection with a group health plan and 
     a participant or beneficiary. Determinations under such 
     procedures shall be non-appealable.
       ``(d) Internal Appeal of Coverage Determinations.--
       ``(1) Right to appeal.--
       ``(A) In general.--A participant or beneficiary (or the 
     authorized representative of the participant or beneficiary) 
     or the treating health care professional with the consent of 
     the participant or beneficiary (or the authorized 
     representative of the participant or beneficiary), may appeal 
     any adverse coverage determination under subsection (b) under 
     the procedures described in this subsection.
       ``(B) Time for appeal.--A plan or issuer shall ensure that 
     a participant or beneficiary has a period of not less than 
     180 days beginning on the date of an adverse coverage 
     determination under subsection (b) in which to appeal such 
     determination under this subsection.
       ``(C) Failure to act.--The failure of a plan or issuer to 
     issue a determination under subsection (b) within the 
     applicable timeline established for such a determination 
     under such subsection shall be treated as an adverse coverage 
     determination for purposes of proceeding to internal review 
     under this subsection.
       ``(2) Records.--A group health plan and a health insurance 
     issuer shall maintain written records, for at least 6 years, 
     with respect to any appeal under this subsection for purposes 
     of internal quality assurance and improvement. Nothing in the 
     preceding sentence shall be construed as preventing a plan 
     and issuer from entering into an agreement under which the 
     issuer agrees to assume responsibility for compliance with 
     the requirements of this section and the plan is released 
     from liability for such compliance.
       ``(3) Routine determinations.--A group health plan or a 
     health insurance issuer shall complete the consideration of 
     an appeal of an adverse routine determination under this 
     subsection not later than 30 working days after the date on 
     which a request for such appeal is received.
       ``(4) Expedited determination.--
       ``(A) In general.--An expedited determination with respect 
     to an appeal under this subsection shall be made in 
     accordance with the medical exigencies of the case, but in no 
     case more than 72 hours after the request for such appeal is 
     received by the plan or issuer under subparagraph (B) or (C).
       ``(B) Request by participant or beneficiary.--A plan or 
     issuer shall maintain procedures for expediting a prior 
     authorization determination under this subsection upon the 
     request of a participant or beneficiary if, based on such a 
     request, the plan or issuer determines that the normal time 
     for making such a determination could seriously jeopardize 
     the life or health of the participant or beneficiary.
       ``(C) Documentation by health care professional.--A plan or 
     issuer shall maintain procedures for expediting a prior 
     authorization determination under this subsection if the 
     request involved indicates that the treating health care 
     professional has reasonably documented, based on the medical 
     exigencies of the case that a determination under the 
     procedures described in paragraph (2) could seriously 
     jeopardize the life or health of the participant or 
     beneficiary.
       ``(5) Conduct of review.--A review of an adverse coverage 
     determination under this subsection shall be conducted by an 
     individual with appropriate expertise who was not directly 
     involved in the initial determination.
       ``(6) Lack of medical necessity.--A review of an appeal 
     under this subsection relating to a determination to deny 
     coverage based on a lack of medical necessity and 
     appropriateness, or based on an experimental or 
     investigational treatment, shall be made only by a physician 
     with appropriate expertise, including age-appropriate 
     expertise, who was not involved in the initial determination.
       ``(7) Notice.--
       ``(A) In general.--Written notice of a determination made 
     under an internal review process shall be issued to the 
     participant or beneficiary (or the authorized representative 
     of the participant or beneficiary) and the treating health 
     care professional not later than 2 working days after the 
     completion of the review (or within the 72-hour period 
     referred to in paragraph (4) if applicable).
       ``(B) Adverse coverage determinations.--With respect to an 
     adverse coverage determination made under this subsection, 
     the notice described in subparagraph (A) shall include--
       ``(i) the reasons for the determination (including the 
     clinical or scientific-evidence based rationale used in 
     making the determination) written in a manner to be 
     understandable to the average participant or beneficiary;
       ``(ii) the procedures for obtaining additional information 
     concerning the determination; and
       ``(iii) notification of the right to an independent 
     external review under subsection (e) and instructions on how 
     to initiate such a review.
       ``(e) Independent External Review.--
       ``(1) Access to review.--
       ``(A) In general.--A group health plan or a health 
     insurance issuer offering health insurance coverage in 
     connection with a group health plan shall have written 
     procedures to permit a participant or beneficiary (or the 
     authorized representative of the participant or beneficiary) 
     access to an independent external review with respect to an 
     adverse coverage determination concerning a particular item 
     or service (including a circumstance treated as an adverse 
     coverage determination under subparagraph (B)) where--
       ``(i) the particular item or service involved--

       ``(I)(aa) would be a covered benefit, when medically 
     necessary and appropriate under the terms and conditions of 
     the plan, and the item or service has been determined not to 
     be medically necessary and appropriate under the internal 
     appeals process required under subsection (d) or there has 
     been a failure to issue a coverage determination as described 
     in subparagraph (B); and
       ``(bb)(AA) the amount of such item or service involved 
     exceeds a significant financial threshold; or

       ``(BB) there is a significant risk of placing the life or 
     health of the participant or beneficiary in jeopardy; or
       ``(II) would be a covered benefit, when not considered 
     experimental or investigational under the terms and 
     conditions of the plan, and the item or service has been 
     determined to be experimental or investigational under the 
     internal appeals process required under subsection (d) or 
     there has been a failure to

[[Page 15524]]

     issue a coverage determination as described in subparagraph 
     (B); and

       ``(ii) the participant or beneficiary has completed the 
     internal appeals process under subsection (d) with respect to 
     such determination.
       ``(B) Failure to act.--The failure of a plan or issuer to 
     issue a coverage determination under subsection (d)(6) within 
     the applicable timeline established for such a determination 
     under such subsection shall be treated as an adverse coverage 
     determination for purposes of proceeding to independent 
     external review under this subsection.
       ``(2) Initiation of the independent external review 
     process.--
       ``(A) Filing of request.--A participant or beneficiary (or 
     the authorized representative of the participant or 
     beneficiary) who desires to have an independent external 
     review conducted under this subsection shall file a written 
     request for such a review with the plan or issuer involved 
     not later than 30 working days after the receipt of a final 
     denial of a claim under subsection (d). Any such request 
     shall include the consent of the participant or beneficiary 
     (or the authorized representative of the participant or 
     beneficiary) for the release of medical information and 
     records to independent external reviewers regarding the 
     participant or beneficiary.
       ``(B) Information and notice.--Not later than 5 working 
     days after the receipt of a request under subparagraph (A), 
     or earlier in accordance with the medical exigencies of the 
     case, the plan or issuer involved shall select an external 
     appeals entity under paragraph (3)(A) that shall be 
     responsible for designating an independent external reviewer 
     under paragraph (3)(B).
       ``(C) Provision of information.--The plan or issuer 
     involved shall forward necessary information (including 
     medical records, any relevant review criteria, the clinical 
     rationale consistent with the terms and conditions of the 
     contract between the plan or issuer and the participant or 
     beneficiary for the coverage denial, and evidence of the 
     coverage of the participant or beneficiary) to the 
     independent external reviewer selected under paragraph 
     (3)(B).
       ``(D) Notification.--The plan or issuer involved shall send 
     a written notification to the participant or beneficiary (or 
     the authorized representative of the participant or 
     beneficiary) and the plan administrator, indicating that an 
     independent external review has been initiated.
       ``(3) Conduct of independent external review.--
       ``(A) Designation of external appeals entity by plan or 
     issuer.--
       ``(i) In general.--A plan or issuer that receives a request 
     for an independent external review under paragraph (2)(A) 
     shall designate a qualified entity described in clause (ii), 
     in a manner designed to ensure that the entity so designated 
     will make a decision in an unbiased manner, to serve as the 
     external appeals entity.
       ``(ii) Qualified entities.--A qualified entity shall be--

       ``(I) an independent external review entity licensed or 
     credentialed by a State;
       ``(II) a State agency established for the purpose of 
     conducting independent external reviews;
       ``(III) any entity under contract with the Federal 
     Government to provide independent external review services;
       ``(IV) any entity accredited as an independent external 
     review entity by an accrediting body recognized by the 
     Secretary for such purpose; or
       ``(V) any other entity meeting criteria established by the 
     Secretary for purposes of this subparagraph.

       ``(B) Designation of independent external reviewer by 
     external appeals entity.--The external appeals entity 
     designated under subparagraph (A) shall, not later than 30 
     days after the date on which such entity is designated under 
     subparagraph (A), or earlier in accordance with the medical 
     exigencies of the case, designate one or more individuals to 
     serve as independent external reviewers with respect to a 
     request received under paragraph (2)(A). Such reviewers shall 
     be independent medical experts who shall--
       ``(i) be appropriately credentialed or licensed in any 
     State to deliver health care services;
       ``(ii) not have any material, professional, familial, or 
     financial affiliation with the case under review, the 
     participant or beneficiary involved, the treating health care 
     professional, the institution where the treatment would take 
     place, or the manufacturer of any drug, device, procedure, or 
     other therapy proposed for the participant or beneficiary 
     whose treatment is under review;
       ``(iii) have expertise (including age-appropriate 
     expertise) in the diagnosis or treatment under review and, 
     when reasonably available, be of the same specialty as the 
     physician treating the participant or beneficiary or 
     recommending or prescribing the treatment in question;
       ``(iv) receive only reasonable and customary compensation 
     from the group health plan or health insurance issuer in 
     connection with the independent external review that is not 
     contingent on the decision rendered by the reviewer; and
       ``(v) not be held liable for decisions regarding medical 
     determinations (but may be held liable for actions that are 
     arbitrary and capricious).
       ``(4) Standard of review.--
       ``(A) In general.--An independent external reviewer shall--
       ``(i) make an independent determination based on the valid, 
     relevant, scientific and clinical evidence to determine the 
     medical necessity, appropriateness, experimental or 
     investigational nature of the proposed treatment; and
       ``(ii) take into consideration appropriate and available 
     information, including any evidence-based decision making or 
     clinical practice guidelines used by the group health plan or 
     health insurance issuer; timely evidence or information 
     submitted by the plan, issuer, patient or patient's 
     physician; the patient's medical record; expert consensus; 
     and medical literature as defined in section 556(5) of the 
     Federal Food, Drug, and Cosmetic Act.
       ``(B) Notice.--The plan or issuer involved shall ensure 
     that the participant or beneficiary receives notice, within 
     30 days after the determination of the independent medical 
     expert, regarding the actions of the plan or issuer with 
     respect to the determination of such expert under the 
     independent external review.
       ``(5) Timeframe for review.--
       ``(A) In general.--The independent external reviewer shall 
     complete a review of an adverse coverage determination in 
     accordance with the medical exigencies of the case.
       ``(B) Limitation.--Notwithstanding subparagraph (A), a 
     review described in such subparagraph shall be completed not 
     later than 30 working days after the later of--
       ``(i) the date on which such reviewer is designated; or
       ``(ii) the date on which all information necessary to 
     completing such review is received.
       ``(6) Binding determination.--The determination of an 
     independent external reviewer under this subsection shall be 
     binding upon the plan or issuer if the provisions of this 
     subsection or the procedures implemented under such 
     provisions were complied with by the independent external 
     reviewer.
       ``(7) Study.--Not later than 2 years after the date of 
     enactment of this section, the General Accounting Office 
     shall conduct a study of a statistically appropriate sample 
     of completed independent external reviews. Such study shall 
     include an assessment of the process involved during an 
     independent external review and the basis of decisionmaking 
     by the independent external reviewer. The results of such 
     study shall be submitted to the appropriate committees of 
     Congress.
       ``(8) Effect on certain provisions.--Nothing in this 
     section shall be construed as affecting or modifying section 
     514 of this Act with respect to a group health plan.
       ``(f) Rule of Construction.--Nothing in this section shall 
     be construed to prohibit a plan administrator or plan 
     fiduciary or health plan medical director from requesting an 
     independent external review by an independent external 
     reviewer without first completing the internal review 
     process.
       ``(g) Definitions.--In this section:
       ``(1) Adverse coverage determination.--The term `adverse 
     coverage determination' means a coverage determination under 
     the plan which results in a denial of coverage or 
     reimbursement.
       ``(2) Coverage determination.--The term `coverage 
     determination' means with respect to items and services for 
     which coverage may be provided under a health plan, a 
     determination of whether or not such items and services are 
     covered or reimbursable under the coverage and terms of the 
     contract.
       ``(3) Grievance.--The term `grievance' means any complaint 
     made by a participant or beneficiary that does not involve a 
     coverage determination.
       ``(4) Group health plan.--The term `group health plan' 
     shall have the meaning given such term in section 733(a). In 
     applying this paragraph, excepted benefits described in 
     section 733(c) shall not be treated as benefits consisting of 
     medical care.
       ``(5) Health insurance coverage.--The term `health 
     insurance coverage' has the meaning given such term in 
     section 733(b)(1). In applying this paragraph, excepted 
     benefits described in section 733(c) shall not be treated as 
     benefits consisting of medical care.
       ``(6) Health insurance issuer.--The term `health insurance 
     issuer' has the meaning given such term in section 733(b)(2).
       ``(7) Prior authorization determination.--The term `prior 
     authorization determination' means a coverage determination 
     prior to the provision of the items and services as a 
     condition of coverage of the items and services under the 
     coverage.
       ``(8) Treating health care professional.--The term 
     `treating health care professional' with respect to a group 
     health plan, health insurance issuer or provider sponsored 
     organization means a physician (medical doctor or doctor of 
     osteopathy) or other health care practitioner who is acting 
     within the scope of his or her State licensure or 
     certification for the delivery of health care services and 
     who is primarily responsible for delivering those services to 
     the participant or beneficiary.
       ``(9) Utilization review.--The term `utilization review' 
     with respect to a group health plan or health insurance 
     coverage means a

[[Page 15525]]

     set of formal techniques designed to monitor the use of, or 
     evaluate the clinical necessity, appropriateness, efficacy, 
     or efficiency of, health care services, procedures, or 
     settings. Techniques may include ambulatory review, 
     prospective review, second opinion, certification, concurrent 
     review, case management, discharge planning or retrospective 
     review.''
       (b) Enforcement.--Section 502(c)(1) of the Employee 
     Retirement Income Security Act of 1974 (29 U.S.C. 1132(c)(1)) 
     is amended by inserting after ``or section 101(e)(1)'' the 
     following: ``, or fails to comply with a coverage 
     determination as required under section 503(e)(6),''.
       (c) Conforming Amendment.--The table of contents in section 
     1 of the Employee Retirement Income Security Act of 1974 is 
     amended by striking the item relating to section 503 and 
     inserting the following new item:

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

               TITLE II--GENETIC INFORMATION AND SERVICES

     SEC. 201. SHORT TITLE.

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

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

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

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

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

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

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

       (a) Amendments Relating to the Group Market.--
       (1) Prohibition of health discrimination on the basis of 
     genetic information in the group market.--
       (A) No enrollment restriction for genetic services.--
     Section 2702(a)(1)(F) of the

[[Page 15526]]

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

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

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

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

       ``(a) Prohibition on Predictive Genetic Information as a 
     Condition of Eligibility.--A health insurance issuer offering 
     health insurance coverage in the individual market may not 
     use predictive genetic information as a condition of 
     eligibility of an individual to enroll in individual health 
     insurance coverage (including information about a request for 
     or receipt of genetic services).
       ``(b) Prohibition on Predictive Genetic Information in 
     Setting Premium Rates.--A health insurance issuer offering 
     health insurance coverage in the individual market shall not 
     adjust premium rates for individuals on the basis of 
     predictive genetic information concerning such an individual 
     (including a dependent) or a family member of the individual 
     (including information about a request for or receipt of 
     genetic services).
       ``(c) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     health insurance issuer offering health insurance coverage in 
     the individual market shall not request or require predictive 
     genetic information concerning any individual (including a 
     dependent) or a family member of the individual (including 
     information about a request for or receipt of genetic 
     services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) in general.--Notwithstanding paragraph (1), a health 
     insurance issuer offering health insurance coverage in the 
     individual market that provides health care items and 
     services to an individual or dependent may request (but may 
     not require) that such individual or dependent disclose, or 
     authorize the collection or disclosure of, predictive genetic 
     information for purposes of diagnosis, treatment, or payment 
     relating to the provision of health care items and services 
     to such individual or dependent.
       ``(B) Notice of confidentiality practices and description 
     of safeguards.--As a part of a request under subparagraph 
     (A), the health insurance issuer offering health insurance 
     coverage in the individual market shall provide to the 
     individual or dependent a description of the procedures in 
     place to safeguard the confidentiality, as described in 
     subsection (d), of such predictive genetic information.

[[Page 15527]]

       ``(d) Confidentiality with Respect to Predictive Genetic 
     Information.--
       ``(1) Notice of confidentiality practices.--
       ``(A) Preparation of written notice.--A health insurance 
     issuer offering health insurance coverage in the individual 
     market shall post or provide, in writing and in a clear and 
     conspicuous manner, notice of the issuer's confidentiality 
     practices, that shall include--
       ``(i) a description of an individual's rights with respect 
     to predictive genetic information;
       ``(ii) the procedures established by the issuer for the 
     exercise of the individual's rights; and
       ``(iii) the right to obtain a copy of the notice of the 
     confidentiality practices required under this subsection.
       ``(B) Model notice.--The Secretary, in consultation with 
     the National Committee on Vital and Health Statistics and the 
     National Association of Insurance Commissioners, and after 
     notice and opportunity for public comment, shall develop and 
     disseminate model notices of confidentiality practices. Use 
     of the model notice shall serve as a defense against claims 
     of receiving inappropriate notice.
       ``(2) Establishment of safeguards.--A health insurance 
     issuer offering health insurance coverage in the individual 
     market shall establish and maintain appropriate 
     administrative, technical, and physical safeguards to protect 
     the confidentiality, security, accuracy, and integrity of 
     predictive genetic information created, received, obtained, 
     maintained, used, transmitted, or disposed of by such 
     issuer.''.
       (c) Effective Date.--The amendments made by this section 
     shall apply with respect to--
       (1) group health plans, and health insurance coverage 
     offered in connection with group health plans, for plan years 
     beginning after 1 year after the date of enactment of this 
     Act; and
       (2) health insurance coverage offered, sold, issued, 
     renewed, in effect, or operated in the individual market 
     after 1 year after the date of enactment of this Act.

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

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

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

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

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

               TITLE III--HEALTHCARE RESEARCH AND QUALITY

     SEC. 301. SHORT TITLE.

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

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

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

[[Page 15528]]



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

               ``PART A--ESTABLISHMENT AND GENERAL DUTIES

     ``SEC. 901. MISSION AND DUTIES.

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

     ``SEC. 902. GENERAL AUTHORITIES.

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

               ``PART B--HEALTHCARE IMPROVEMENT RESEARCH

     ``SEC. 911. HEALTHCARE OUTCOME IMPROVEMENT RESEARCH.

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

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

       ``(a) Support for Efforts To Develop Information on 
     Quality.--
       ``(1) Scientific and technical support.--In its role as the 
     principal agency for healthcare research and quality, the 
     Agency may provide scientific and technical support for 
     private and public efforts to improve healthcare quality, 
     including the activities of accrediting organizations.
       ``(2) Role of the agency.--With respect to paragraph (1), 
     the role of the Agency shall include--
       ``(A) the identification and assessment of methods for the 
     evaluation of the health of--
       ``(i) enrollees in health plans by type of plan, provider, 
     and provider arrangements; and
       ``(ii) other populations, including those receiving long-
     term care services;
       ``(B) the ongoing development, testing, and dissemination 
     of quality measures, including measures of health and 
     functional outcomes;
       ``(C) the compilation and dissemination of healthcare 
     quality measures developed in the private and public sector;
       ``(D) assistance in the development of improved healthcare 
     information systems;
       ``(E) the development of survey tools for the purpose of 
     measuring participant and beneficiary assessments of their 
     healthcare; and
       ``(F) identifying and disseminating information on 
     mechanisms for the integration of information on quality into 
     purchaser and consumer decision-making processes.
       ``(b) Centers for Education and Research on Therapeutics.--
       ``(1) In general.--The Secretary, acting through the 
     Director and in consultation with the Commissioner of Food 
     and Drugs, shall establish a program for the purpose of 
     making one or more grants for the establishment and operation 
     of one or more centers to carry out the activities specified 
     in paragraph (2).

[[Page 15529]]

       ``(2) Required activities.--The activities referred to in 
     this paragraph are the following:
       ``(A) The conduct of state-of-the-art clinical, laboratory, 
     or health services research for the following purposes:
       ``(i) To increase awareness of--

       ``(I) new uses of drugs, biological products, and devices;
       ``(II) ways to improve the effective use of drugs, 
     biological products, and devices; and
       ``(III) risks of new uses and risks of combinations of 
     drugs and biological products.

       ``(ii) To provide objective clinical information to the 
     following individuals and entities:

       ``(I) Healthcare practitioners and other providers of 
     healthcare goods or services.

       ``(II) Pharmacists, pharmacy benefit managers and 
     purchasers.
       ``(III) Health maintenance organizations and other managed 
     healthcare organizations.
       ``(IV) Healthcare insurers and governmental agencies.
       ``(V) Patients and consumers.

       ``(iii) To improve the quality of healthcare while reducing 
     the cost of Healthcare through--

       ``(I) an increase in the appropriate use of drugs, 
     biological products, or devices; and
       ``(II) the prevention of adverse effects of drugs, 
     biological products, and devices and the consequences of such 
     effects, such as unnecessary hospitalizations.

       ``(B) The conduct of research on the comparative 
     effectiveness, cost-effectiveness, and safety of drugs, 
     biological products, and devices.
       ``(C) Such other activities as the Secretary determines to 
     be appropriate, except that grant funds may not be used by 
     the Secretary in conducting regulatory review of new drugs.
       ``(c) Reducing Errors in Medicine.--The Director shall 
     conduct and support research and build private-public 
     partnerships to--
       ``(1) identify the causes of preventable healthcare errors 
     and patient injury in healthcare delivery;
       ``(2) develop, demonstrate, and evaluate strategies for 
     reducing errors and improving patient safety; and
       ``(3) promote the implementation of effective strategies 
     throughout the healthcare industry.

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

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

     In expanding the Medical Expenditure Panel Survey, as in 
     existence on the date of enactment of this title, in fiscal 
     year 2001 to collect information on the quality of care, the 
     Director shall take into account any outcomes measurements 
     generally collected by private sector accreditation 
     organizations.
       ``(2) Annual report.--Beginning in fiscal year 2003, the 
     Secretary, acting through the Director, shall submit to 
     Congress an annual report on national trends in the quality 
     of healthcare provided to the American people.

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

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

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

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

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

       ``(a) In General.--The Director shall promote innovation in 
     evidence-based clinical practice and healthcare technologies 
     by--
       ``(1) conducting and supporting research on the 
     development, diffusion, and use of healthcare technology;
       ``(2) developing, evaluating, and disseminating 
     methodologies for assessments of healthcare practices and 
     healthcare technologies;
       ``(3) conducting intramural and supporting extramural 
     assessments of existing and new healthcare practices and 
     technologies;
       ``(4) promoting education, training, and providing 
     technical assistance in the use of healthcare practice and 
     healthcare technology assessment methodologies and results; 
     and
       ``(5) working with the National Library of Medicine and the 
     public and private sector to develop an electronic 
     clearinghouse of currently available assessments and those in 
     progress.
       ``(b) Specification of Process.--
       ``(1) In general.--Not later than December 31, 2000, the 
     Director shall develop and publish a description of the 
     methodology used by the Agency and its contractors in 
     conducting practice and technology assessment.
       ``(2) Consultations.--In carrying out this subsection, the 
     Director shall cooperate and consult with the Assistant 
     Secretary for Health, the Administrator of the Health Care 
     Financing Administration, the Director of the National 
     Institutes of Health, the Commissioner of Food and Drugs, and 
     the heads of any other interested Federal department or 
     agency, and shall seek input, where appropriate, from 
     professional societies and other private and public entities.
       ``(3) Methodology.--The Director, in developing assessment 
     methodology, shall consider--

[[Page 15530]]

       ``(A) safety, efficacy, and effectiveness;
       ``(B) legal, social, and ethical implications;
       ``(C) costs, benefits, and cost-effectiveness;
       ``(D) comparisons to alternate technologies and practices; 
     and
       ``(E) requirements of Food and Drug Administration approval 
     to avoid duplication.
       ``(c) Specific Assessments.--
       ``(1) In general.--The Director shall conduct or support 
     specific assessments of healthcare technologies and 
     practices.
       ``(2) Requests for assessments.--The Director is authorized 
     to conduct or support assessments, on a reimbursable basis, 
     for the Health Care Financing Administration, the Department 
     of Defense, the Department of Veterans Affairs, the Office of 
     Personnel Management, and other public or private entities.
       ``(3) Grants and contracts.--In addition to conducting 
     assessments, the Director may make grants to, or enter into 
     cooperative agreements or contracts with, entities described 
     in paragraph (4) for the purpose of conducting assessments of 
     experimental, emerging, existing, or potentially outmoded 
     healthcare technologies, and for related activities.
       ``(4) Eligible entities.--An entity described in this 
     paragraph is an entity that is determined to be appropriate 
     by the Director, including academic medical centers, research 
     institutions and organizations, professional organizations, 
     third party payers, governmental agencies, and consortia of 
     appropriate research entities established for the purpose of 
     conducting technology assessments.

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

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

                      ``PART C--GENERAL PROVISIONS

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

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

[[Page 15531]]

     unless declined by the member. Such compensation may not be 
     in an amount in excess of the daily equivalent of the annual 
     rate of basic pay prescribed for level IV of the Executive 
     Schedule under section 5315 of title 5, United States Code, 
     for each day during which such member is engaged in the 
     performance of the duties of the Advisory Council.
       ``(2) Ex officio members.--Officials designated under 
     subsection (c)(3) as ex officio members of the Advisory 
     Council may not receive compensation for service on the 
     Advisory Council in addition to the compensation otherwise 
     received for duties carried out as officers of the United 
     States.
       ``(i) Staff.--The Director shall provide to the Advisory 
     Council such staff, information, and other assistance as may 
     be necessary to carry out the duties of the Council.

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

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

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

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

     ``SEC. 924. DISSEMINATION OF INFORMATION.

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

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

       ``(a) Financial Conflicts of Interest.--With respect to 
     projects for which awards of grants, cooperative agreements, 
     or contracts are authorized to be made under this title, the 
     Director shall by regulation define--
       ``(1) the specific circumstances that constitute financial 
     interests in such projects that will, or may be reasonably 
     expected to, create a bias in favor of obtaining results in 
     the projects that are consistent with such interests; and
       ``(2) the actions that will be taken by the Director in 
     response to any such interests identified by the Director.
       ``(b) Requirement of Application.--The Director may not, 
     with respect to any program under this title authorizing the 
     provision of grants, cooperative agreements, or contracts, 
     provide any such financial assistance unless an application 
     for the assistance is submitted to the Secretary and the 
     application is in such form, is made in such manner, and 
     contains such agreements, assurances, and information as the 
     Director determines to be necessary to carry out the program 
     in involved.

[[Page 15532]]

       ``(c) Provision of Supplies and Services in Lieu of 
     Funds.--
       ``(1) In general.--Upon the request of an entity receiving 
     a grant, cooperative agreement, or contract under this title, 
     the Secretary may, subject to paragraph (2), provide 
     supplies, equipment, and services for the purpose of aiding 
     the entity in carrying out the project involved and, for such 
     purpose, may detail to the entity any officer or employee of 
     the Department of Health and Human Services.
       ``(2) Corresponding reduction in funds.--With respect to a 
     request described in paragraph (1), the Secretary shall 
     reduce the amount of the financial assistance involved by an 
     amount equal to the costs of detailing personnel and the fair 
     market value of any supplies, equipment, or services provided 
     by the Director. The Secretary shall, for the payment of 
     expenses incurred in complying with such request, expend the 
     amounts withheld.
       ``(d) Applicability of Certain Provisions With Respect to 
     Contracts.--Contracts may be entered into under this part 
     without regard to sections 3648 and 3709 of the Revised 
     Statutes (31 U.S.C. 529; 41 U.S.C. 5).

     ``SEC. 926. CERTAIN ADMINISTRATIVE AUTHORITIES.

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

     ``SEC. 927. FUNDING.

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

     ``SEC. 928. DEFINITIONS.

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

     SEC. 303. REFERENCES.

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

                   TITLE IV--MISCELLANEOUS PROVISIONS

     SEC. 401. SENSE OF THE COMMITTEE.

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

                KENNEDY (AND OTHERS) AMENDMENT NO. 1233

  Mr. DASCHLE (for Mr. Kennedy) (for himself, Mr. Reid, Mr. Durbin, Mr. 
Wellstone, Mr. Wyden, Mr. Reed, Mrs. Murray, Mr. Daschle, and Mr. 
Chafee) proposed an amendment to amendment No. 1232 proposed by Mr. 
Daschle to the bill, S. 1344, supra; as follows:

       At the appropriate place insert the following:

     SEC. __. APPLICATION TO ALL HEALTH PLANS.

       (a) ERISA.--Subpart C of part 7 of subtitle B of title I of 
     the Employee Retirement Income Security Act of 1974, as added 
     by section 101(a)(2) of this Act, is amended by adding at the 
     end the following:

     ``SEC. 730A. APPLICATION OF PROVISIONS.

       ``(a) Application to Group Health Plans.--The provisions of 
     this subpart, and sections 714 and 503, shall apply to group 
     health plans and health insurance issuers offering health 
     insurance coverage in connection with a group health plan.
       ``(b) Treatment of Multiple Coverage Options.--In the case 
     of a group health plan that provides benefits under 2 or more 
     coverage options, the requirements of this subpart, other 
     than section 722, shall apply separately with respect to each 
     coverage option.
       ``(c) Plan Satisfaction of Certain Requirements.--
       ``(1) Satisfaction of certain requirements through 
     insurance.--For purposes of subsection (a), insofar as a 
     group health plan provides benefits in the form of health 
     insurance coverage through a health insurance issuer, the 
     plan shall be treated as meeting the following requirements 
     of this Act with respect to such benefits and not be 
     considered as failing to meet such requirements because of a 
     failure of the issuer to meet such requirements so long as 
     the plan sponsor or its representatives did not cause such 
     failure by the issuer:
       ``(A) section 721 (relating to access to emergency care).
       ``(B) Section 722 (relating to choice of coverage options), 
     but only insofar as the plan is

[[Page 15533]]

     meeting such requirement through an agreement with the issuer 
     to offer the option to purchase point-of-service coverage 
     under such section.
       ``(C) Section 723, 724 and 725 (relating to access to 
     specialty care).
       ``(D) Section 726) (relating to continuity in case of 
     termination of provider (or, issuer in connection with health 
     insurance coverage) contract) but only insofar as a 
     replacement issuer assumes the obligation for continuity of 
     care.
       ``(E) Section 727 (relating to patient-provider 
     communications).
       ``(F) Section 728 (relating to prescription drugs).
       ``(G) Section 729 (relating to self-payment for certain 
     services).
       ``(2) Information.--With respect to information required to 
     be provided or made available under section 714, in the case 
     of a group health plan that provides benefits in the form of 
     health insurance coverage through a health insurance issuer, 
     the Secretary shall determine the circumstances under which 
     the plan is not required to provide or make available the 
     information (and is not liable for the issuer's failure to 
     provide or make available the information), if the issuer is 
     obligated to provide and make available (or provides and 
     makes available) such information.
       ``(3) Grievance and internal appeals.--With respect to the 
     grievance system and internal appeals process required to be 
     established under section 503, in the case of a group health 
     plan that provides benefits in the form of health insurance 
     coverage through a health insurance issuer, the Secretary 
     shall determine the circumstances under which the plan is not 
     required to provide for such system and process (and is not 
     liable for the issuer's failure to provide for such system 
     and process), if the issuer is obligated to provide for (and 
     provides for) such system and process.
       ``(4) External appeals.--Pursuant to rules of the 
     Secretary, insofar as a group health plan enters into a 
     contract with a qualified external appeal entity for the 
     conduct of external appeal activities in accordance with 
     section 503, the plan shall be treated as meeting the 
     requirement of such section and is not liable for the 
     entity's failure to meet any requirements under such section.
       ``(5) Application to prohibitions.--Pursuant to rules of 
     the Secretary, if a health insurance issuer offers health 
     insurance coverage in connection with a group health plan and 
     takes an action in violation of section 727, the group health 
     plan shall not be liable for such violation unless the plan 
     caused such violation.
       ``(6) Construction.--Nothing in this subsection shall be 
     construed to affect or modify the responsibilities of the 
     fiduciaries of a group health plan under part 4 of subtitle 
     B.
       ``(d) Conforming Regulations.--The Secretary may issue 
     regulations to coordinate the requirements on group health 
     plans under this section with the requirements imposed under 
     the other provisions of this title.''.
       (b) Application to Group Market Under Public Health Service 
     Act.--Subpart 2 of part A of title XXVII of the Public Health 
     Service Act (42 U.S.C. 300gg-4 et seq.), as amended by 
     section 203(a)(1)(B), is further amended by adding at the end 
     the following new section:

     ``SEC. 2708. PATIENT PROTECTION STANDARDS.

       ``(a) In General.--Each group health plan shall comply with 
     the following patient protection requirements, and each 
     health insurance issuer shall comply with such patient 
     protection requirements with respect to group health 
     insurance coverage it offers, and such requirements shall be 
     deemed to be incorporated into this subsection:
       ``(1) The requirements of subpart C of part 7 of subtitle B 
     of title I of the Employee Retirement Income Security Act of 
     1974.
       ``(2) The requirements of section 714 of the Employee 
     Retirement Income Security Act of 1974.
       ``(3) The requirements of subsections (b) through (g) of 
     section 503 of the Employee Retirement Income Security Act of 
     1974.
       ``(b) Notice.--A group health plan shall comply with the 
     notice requirement under section 104(b)(1) of the Employee 
     Retirement Income Security Act of 1974 with respect to the 
     requirements referred to in subsection (a) and a health 
     insurance issuer shall comply with such notice requirement as 
     if such section applied to such issuer and such issuer were a 
     group health plan.''.
       (c) Application to Individual Market Under Public Health 
     Service Act.--Subpart 3 of part B of title XXVII of the 
     Public Health Service Act (42 U.S.C. 300gg-51 et seq.), as 
     amended by section 203(b)(2), is further amended by adding at 
     the end the following new section:

     ``SEC. 2754. PATIENT PROTECTION STANDARDS.

       ``(a) In General.--Each health insurance issuer shall 
     comply with the following patient protection requirements 
     with respect to individual health insurance coverage it 
     offers, and such requirements shall be deemed to be 
     incorporated into this subsection:
       ``(1) The requirements of subpart C of part 7 of subtitle B 
     of title I of the Employee Retirement Income Security Act of 
     1974.
       ``(2) The requirements of section 714 of the Employee 
     Retirement Income Security Act of 1974.
       ``(3) The requirements of section 503 of the Employee 
     Retirement Income Security Act of 1974.
       ``(b) Notice.--A health insurance issuer under this part 
     shall comply with the notice requirement under section 
     104(b)(1) of the Employee Retirement Income Security Act of 
     1974 with respect to the requirements of such subtitle as if 
     such section applied to such issuer and such issuer were a 
     group health plan.
       ``(c) Nonapplication of Certain Provision.--Section 2763(a) 
     shall not apply to the provisions of this section.''.
       (d) Application to Group Health Plans Under the Internal 
     Revenue Code of 1986.--
       Subchapter B of chapter 100 of the Internal Revenue Code of 
     1986 is amended--
       (1) in the table of sections, by inserting after the item 
     relating to section 9812 the following new item:

``Sec. 9813. Standard relating to patients' bill of rights.''; and
       (2) by inserting after section 9812 the following:

     ``SEC. 9813. STANDARD RELATING TO PATIENTS' BILL OF RIGHTS.

       ``A group health plan shall comply with the following 
     requirements (as in effect as of the date of the enactment of 
     such Act), and such requirements shall be deemed to be 
     incorporated into this section:
       ``(1) The requirements of subpart C of part 7 of subtitle B 
     of title I of the Employee Retirement Income Security Act of 
     1974.
       ``(2) The requirements of section 714 of the Employee 
     Retirement Income Security Act of 1974.
       ``(3) The requirements of section 503 of the Employee 
     Retirement Income Security Act of 1974.''.
       (e) Conforming Amendment.--Section 2721(b)(2)(A) of the 
     Public Health Service Act (42 U.S.C. 300gg-21(b)(2)(A)) is 
     amended by inserting ``(other than section 2708)'' after 
     ``requirements of such subparts''.
       (f) No Impact on Social Security Trust Fund.--
       (1) In general.--Nothing in the amendments made by this 
     section shall be construed to alter or amend the Social 
     Security Act (or any regulation promulgated under that Act).
       (2) Transfers.--
       (A) Estimate of secretary.--The Secretary of the Treasury 
     shall annually estimate the impact that the enactment of this 
     section has on the income and balances of the trust funds 
     established under section 201 of the Social Security Act (42 
     U.S.C. 401).
       (B) Transfer of funds.--If, under subparagraph (A), the 
     Secretary of the Treasury estimates that the enactment of 
     this section has a negative impact on the income and balances 
     of the trust funds established under section 201 of the 
     Social Security Act (42 U.S.C. 401), the Secretary shall 
     transfer, not less frequently than quarterly, from the 
     general revenues of the Federal Government an amount 
     sufficient so as to ensure that the income and balances of 
     such trust funds are not reduced as a result of the enactment 
     of such section.
       (g) Information Requirements.--
       (1) Information from group health plans.--Section 1862(b) 
     of the Social Security Act (42 U.S.C. 1395y(b)) is amended by 
     adding at the end the following:
       ``(7) Information from group health plans.--
       ``(A) Provision of information by group health plans.--The 
     administrator of a group health plan subject to the 
     requirements of paragraph (1) shall provide to the Secretary 
     such of the information elements described in subparagraph 
     (C) as the Secretary specifies, and in such manner and at 
     such times as the Secretary may specify (but not more 
     frequently than 4 times per year), with respect to each 
     individual covered under the plan who is entitled to any 
     benefits under this title.
       ``(B) Provision of information by employers and employee 
     organizations.--An employer (or employee organization) that 
     maintains or participates in a group health plan subject to 
     the requirements of paragraph (1) shall provide to the 
     administrator of the plan such of the information elements 
     required to be provided under subparagraph (A), and in such 
     manner and at such times as the Secretary may specify, at a 
     frequency consistent with that required under subparagraph 
     (A) with respect to each individual described in subparagraph 
     (A) who is covered under the plan by reason of employment 
     with that employer or membership in the organization.
       ``(C) Information elements.--The information elements 
     described in this subparagraph are the following:
       ``(i) Elements concerning the individual.--

       ``(I) The individual's name.
       ``(II) The individual's date of birth.
       ``(III) The individual's sex.
       ``(IV) The individual's social security insurance number.
       ``(V) The number assigned by the Secretary to the 
     individual for claims under this title.
       ``(VI) The family relationship of the individual to the 
     person who has or had current or employment status with the 
     employer.

       ``(ii) Elements concerning the family member with current 
     or former employment status.--

[[Page 15534]]

       ``(I) The name of the person in the individual's family who 
     has current or former employment status with the employer.
       ``(II) That person's social security insurance number.
       ``(III) The number or other identifier assigned by the plan 
     to that person.
       ``(IV) The periods of coverage for that person under the 
     plan.

       ``(V) The employment status of that person (current or 
     former) during those periods of coverage.
       ``(VI) The classes (of that person's family members) 
     covered under the plan.

       ``(iii) Plan elements.--

       ``(I) The items and services covered under the plan.
       ``(II) The name and address to which claims under the plan 
     are to be sent.

       ``(iv) Elements concerning the employer.--

       ``(I) The employer's name.
       ``(II) The employer's address.
       ``(III) The employer identification number of the employer.

       ``(D) Use of identifiers.--The administrator of a group 
     health plan shall utilize a unique identifier for the plan in 
     providing information under subparagraph (A) and in other 
     transactions, as may be specified by the Secretary, related 
     to the provisions of this subsection. The Secretary may 
     provide to the administrator the unique identifier described 
     in the preceding sentence.
       ``(E) Penalty for noncompliance.--Any entity that knowingly 
     and willfully fails to comply with a requirement imposed by 
     the previous subparagraphs shall be subject to a civil money 
     penalty not to exceed $1,000 for each incident of such 
     failure. The provisions of section 1128A (other than 
     subsections (a) and (b)) shall apply to a civil money penalty 
     under the previous sentence in the same manner as those 
     provisions apply to a penalty or proceeding under section 
     1128A(a).''
       (2) Effective date.--The amendment made by paragraph (1) 
     shall take effect 180 days after the date of the enactment of 
     this Act.
       (h) Modification to Foreign Tax Credit Carryback and 
     Carryover Periods.--
       (1) In general.--Section 904(c) of the Internal Revenue 
     Code of 1986 (relating to limitation on credit) is amended--
       (A) by striking ``in the second preceding taxable year,'', 
     and
       (B) by striking ``or fifth'' and inserting ``fifth, sixth, 
     or seventh''.
       (2) Effective date.--The amendment made by paragraph (1) 
     shall apply to credits arising in taxable years beginning 
     after December 31, 2001.
       (i) Limitations on Welfare Benefit Funds of 10 or More 
     Employer Plans.--
       (1) Benefits to which exception applies.--Section 
     419A(f)(6)(A) of the Internal Revenue Code of 1986 (relating 
     to exception for 10 or more employer plans) is amended to 
     read as follows:
       ``(A) In general.--This subpart shall not apply to a 
     welfare benefit fund which is part of a 10 or more employer 
     plan if the only benefits provided through the fund are 1 or 
     more of the following:
       ``(i) Medical benefits.
       ``(ii) Disability benefits.
       ``(iii) Group term life insurance benefits which do not 
     provide for any cash surrender value or other money that can 
     be paid, assigned, borrowed, or pledged for collateral for a 
     loan.

     The preceding sentence shall not apply to any plan which 
     maintains experience-rating arrangements with respect to 
     individual employers.''
       (2) Limitation on use of amounts for other purposes.--
     Section 4976(b) of such Act (defining disqualified benefit) 
     is amended by adding at the end the following new paragraph:
       ``(5) Special rule for 10 or more employer plans exempted 
     from prefunding limits.--For purposes of paragraph (1)(C), 
     if--
       ``(A) subpart D of part I of subchapter D of chapter 1 does 
     not apply by reason of section 419A(f)(6) to contributions to 
     provide 1 or more welfare benefits through a welfare benefit 
     fund under a 10 or more employer plan, and
       ``(B) any portion of the welfare benefit fund attributable 
     to such contributions is used for a purpose other than that 
     for which the contributions were made,

     then such portion shall be treated as reverting to the 
     benefit of the employers maintaining the fund.''
       (3) Effective date.--The amendments made by this subsection 
     shall apply to contributions paid or accrued after the date 
     of the enactment of this Act, in taxable years ending after 
     such date.
       (j) Modification of Installment Method and Repeal of 
     Installment Method for Accrual Method Taxpayers.--
       (1) Repeal of installment method for accrual basis 
     taxpayers.--
       (A) In general.--Subsection (a) of section 453 of the 
     Internal Revenue Code of 1986 (relating to installment 
     method) is amended to read as follows:
       ``(a) Use of Installment Method.--
       ``(1) In general.--Except as otherwise provided in this 
     section, income from an installment sale shall be taken into 
     account for purposes of this title under the installment 
     method.
       ``(2) Accrual method taxpayer.--The installment method 
     shall not apply to income from an installment sale if such 
     income would be reported under an accrual method of 
     accounting without regard to this section. The preceding 
     sentence shall not apply to a disposition described in 
     subparagraph (A) or (B) of subsection (l)(2).''
       (B) Conforming amendments.--Sections 453(d)(1), 453(i)(1), 
     and 453(k) of such Act are each amended by striking ``(a)'' 
     each place it appears and inserting ``(a)(1)''.
       (2) Modification of pledge rules.--Paragraph (4) of section 
     453A(d) of such Act (relating to pledges, etc., of 
     installment obligations) is amended by adding at the end the 
     following: ``A payment shall be treated as directly secured 
     by an interest in an installment obligation to the extent an 
     arrangement allows the taxpayer to satisfy all or a portion 
     of the indebtedness with the installment obligation.''
       (3) Effective date.--The amendments made by this subsection 
     shall apply to sales or other dispositions occurring on or 
     after the date of the enactment of this Act.
                                 ______
                                 

                SANTORUM (AND OTHERS) AMENDMENT NO. 1234

  Mr. NICKLES (for Mr. Santorum) (for himself, Mr. Bond, Mr. Nickles, 
Mr. Hutchinson, Mr. Craig, and Ms. Collins) proposed an amendment to 
amendment No. 1233 proposed by Mr. Kennedy to the bill, S. 1344, supra; 
as folows:

       Strike all after the first word in line three and insert 
     the following:

     SENSE OF THE SENATE CONCERNING THE SCOPE OF A PATIENTS' BILL 
                   OF RIGHTS.

       (a) Findings.--The Senate makes the following findings:
       (1) Congress agreed that States should have primary 
     responsibility for the regulation of health insurance when it 
     passed the McCarran-Ferguson Act in 1945.
       (2) The States have done a good job in responding to the 
     consumer concerns associated with a rapidly evolving health 
     care delivery system and have already adopted statutory and 
     regulatory protections for consumers in fully-insured health 
     plans and have tailored these protections to fit the needs of 
     their States' consumers and health care marketplaces.
       (3) 117,000,000 Americans who are enrolled in fully insured 
     plans, governmental plans and individual policies are 
     protected by State patient protections.
       (4) Forty-two States have already enacted a Patient's Bill 
     of Rights.
       (5) Forty-seven States already enforce consumer protections 
     regarding gag clauses on doctor-patient communications.
       (6) Forty States already enforce consumer protections for 
     access to emergency care services.
       (7) Thirty-one States already enforce consumer protections 
     requiring a prudent layperson standard for emergency care.
       (8) The Employee Retirement Income Security Act of 1974 
     (referred to in this section as ``ERISA'') expressly 
     prohibits States from regulating the self-funded employer 
     sponsored plans that currently cover 48,000,000 Americans.
       (9) The National Association of Insurance Commissioners has 
     recommended that Congress should focus its legislative 
     activities on consumers in self-funded ERISA plans, which are 
     under the Federal Government's exclusive jurisdiction, and 
     preserve the State protections that already exist for 
     consumers in fully insured ERISA plans.
       (10) The National Association of Insurance Commissioners 
     has expressly stated that they do not endorse the concept of 
     a Federal floor with regard to patient protections.
       (11) Senate bill 6 (106th Congress) would greatly expand 
     the Federal regulatory role over private health insurance.
       (12) It would be inappropriate to set Federal health 
     insurance standards that not only duplicate the 
     responsibility of the 50 State insurance departments but that 
     also would have to be enforced by the Health Care Financing 
     Administration if a State fails to enact the standard.
       (13) One size does not fit all, and what may be appropriate 
     for one State may not be necessary in another.
       (14) It is irresponsible to propose vastly expanding the 
     Federal Government's role in regulating private health 
     insurance at a time when the Health Care Financing 
     Administration is having such a difficult time fulfilling its 
     current and primary responsibilities for Medicare.
       (15) In August, 1998, the United States Court of Appeals 
     affirmed a district court ruling that the Health Care 
     Financing Administration failed to enforce due process 
     requirements and monitor health maintenance organization 
     denials of medical service to medicare beneficiaries.
       (16) On April 13, 1999, the General Accounting Office 
     testified that the Health Care Financing Administration 
     failed to use its authority to ensure that medicare 
     beneficiaries were informed of their appeals rights under 
     managed care plans.
       (17) The General Accounting Office testified at a July, 
     1998 hearing in the Ways and

[[Page 15535]]

     Means Committee of the House of Representatives that the 
     Health Care Financing Administration missed 25 percent of the 
     implementation deadlines for the consumer and quality 
     improvements to the Medicare program under the Balanced 
     Budget Act of 1997.
       (18) The Health Care Financing Administration should not be 
     given new, broad regulatory authority as they have not 
     adequately met their current responsibilities.
       (19) The Health Care Financing Administration took 10 years 
     to implement a 1987 law establishing new nursing home 
     standards.
       (20) The Health Care Financing Administration has yet to 
     update its 1985 fire safety standards for hospitals.
       (21) The Health Care Financing Administration is utilizing 
     1976 health and safety standards for the treatment of end-
     stage kidney disease.
       (22) ERISA preempts State requirements relating to coverage 
     determinations, grievances and appeals, and requirements 
     relating to independent external review.
       (23) In a recent judicial decision in Texas (Corporate 
     Health Insurance, Inc. V. The Texas Department of Insurance), 
     the lower court held that ERISA does preempt the State's 
     external review law as it relates to group health plans.
       (b) Deduction for Health Insurance Costs of Self-Employed 
     Individuals Increased.--In General.--Section 162(l)(1) of the 
     Internal Revenue Code of 1986 (relating to special rules for 
     health insurance costs of self-employed individuals) is 
     amended to read as follows:
       ``(1) Allowance of deduction.--In the case of an individual 
     who is an employee within the meaning of section 401(c)(1), 
     there shall be allowed as a deduction under this section an 
     amount equal to the amount paid during the taxable year for 
     insurance which constitutes medical care for the taxpayer, 
     the taxpayer's spouse, and dependents.''
       (c) Clarification of Limitations on Other Coverage.--The 
     first sentence of section 162(l)(2)(B) of the Internal 
     Revenue Code of 1986 is amended to read as follows: 
     ``Paragraph (1) shall not apply to any taxpayer for any 
     calendar month for which the taxpayer participates in any 
     subsidized health plan maintained by any employer (other than 
     an employer described in section 401(c)(4)) of the taxpayer 
     or the spouse of the taxpayer.''
       (d) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     1998.
                                 ______
                                 

                 GRAHAM (AND OTHERS) AMENDMENT NO. 1235

  Mr. GRAHAM (for himself, Mr. Reid, Mr. Chafee, Mrs. Murray, Mr. 
Durbin, Ms. Mikulski, Mr. Schumer, Mr. Kennedy, Mr. Daschle, Mr. 
Baucus, Mr. Feingold, and Mr. Dorgan) proposed an amendment to 
amendment No. 1233 proposed by Mr. Kennedy to the bill, S. 1344, supra; 
as follows:

       At the appropriate place insert the following:

     SEC. __. ACCESS TO EMERGENCY CARE.

       (a) ERISA.--Subpart C of part 7 of subtitle B of title I of 
     the Employee Retirement Income Security Act of 1974, as added 
     by section 101(a)(2) of this Act, is amended by adding at the 
     end the following:

     ``SEC. 730A. ACCESS TO EMERGENCY CARE.

       ``(a) Coverage of Emergency Services.--
       ``(1) In general.--If a group health plan, or a health 
     insurance issuer in connection with group health insurance 
     coverage, provides any benefits with respect to emergency 
     services (as defined in paragraph (2)(B)), the plan or issuer 
     shall cover emergency services furnished under the plan or 
     coverage--
       ``(A) without the need for any prior authorization 
     determination;
       ``(B) whether or not the health care provider furnishing 
     such services is a participating provider with respect to 
     such services;
       ``(C) in a manner so that, if such services are provided to 
     a participant, beneficiary, or enrollee by a nonparticipating 
     health care provider or without prior authorization by the 
     plan or issuer, the participant, beneficiary or enrollee is 
     not liable for amounts that exceed the amounts of liability 
     that would be incurred if the services were provided by a 
     participating health care provider with prior authorization 
     by the plan or issuer; and
       ``(D) without regard to any other term or condition of such 
     coverage (other than exclusion or coordination of benefits, 
     or an affiliation or waiting period, permitted under section 
     701 (or section 2701 of the Public Health Service Act or 
     section 9801 of the Internal Revenue Code of 1986 as 
     applicable) and other than applicable cost-sharing).
       ``(2) Definitions.--In this section:
       ``(A) Emergency medical condition based on prudent 
     layperson standard.--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 condition 
     described in clause (i), (ii), or (iii) of section 
     1867(e)(1)(A) of the Social Security Act.
       ``(B) Emergency services.--The term `emergency services' 
     means--
       ``(i) a medical screening examination (as required under 
     section 1867 of the Social Security Act) that is within the 
     capability of the emergency department of a hospital, 
     including ancillary services routinely available to the 
     emergency department to evaluate an emergency medical 
     condition (as defined in subparagraph (A)), and
       ``(ii) within the capabilities of the staff and facilities 
     available at the hospital, such further medical examination 
     and treatment as are required under section 1867 of such Act 
     to stabilize the patient.
       ``(b) Reimbursement for Maintenance Care and Post-
     Stabilization Care.--In the case of services (other than 
     emergency services) for which benefits are available under a 
     group health plan, or a health insurance issuer in connection 
     with group health insurance coverage, the plan or issuer 
     shall provide for reimbursement with respect to such services 
     provided to a participant, beneficiary or enrollee other than 
     through a participating health care provider in a manner 
     consistent with subsection (a)(1)(C) (and shall otherwise 
     comply with the guidelines established under section 
     1852(d)(2) of the Social Security Act (relating to promoting 
     efficient and timely coordination of appropriate maintenance 
     and post-stabilization care of a participant, beneficiary or 
     enrollee after a participant, beneficiary or enrollee has 
     been determined to be stable), or, in the absence of 
     guidelines under such section, such guidelines as the 
     Secretary shall establish to carry out this subsection), if 
     the services are maintenance care or post-stabilization care 
     covered under such guidelines.
       ``(c) Coverage of Emergency Ambulance Services.--
       ``(1) In general.--If a group health plan, or health 
     insurance coverage offered by a health insurance issuer, 
     provides any benefits with respect to ambulance services and 
     emergency services, the plan or issuer shall cover emergency 
     ambulance services (as defined in paragraph (2))) furnished 
     under the plan or coverage under the same terms and 
     conditions under subparagraphs (A) through (D) of subsection 
     (a)(1) under which coverage is provided for emergency 
     services.
       ``(2) Emergency ambulance services.--For purposes of this 
     subsection, the term `emergency ambulance services' means 
     ambulance services (as defined for purposes of section 
     1861(s)(7) of the Social Security Act) furnished to transport 
     an individual who has an emergency medical condition (as 
     defined in subsection (a)(2)(A)) to a hospital for the 
     receipt of emergency services (as defined in subsection 
     (a)(2)(B)) in a case in which the emergency services are 
     covered under the plan or coverage pursuant to subsection 
     (a)(1) and a prudent layperson, with an average knowledge of 
     health and medicine, could reasonably expect that the absence 
     of such transport would result in placing the health of the 
     individual in serious jeopardy, serious impairment of bodily 
     function, or serious dysfunction of any bodily organ or part.
       ``(d) Application of Section.--This section shall supersede 
     the provisions of section 721 and section 721 shall have no 
     effect.
       ``(e) Review.--Failure to meet the requirements of this 
     section shall constitute an appealable decision under this 
     Act.
       ``(f) Plan Satisfaction of Certain Requirements.--Pursuant 
     to rules of the Secretary, if a health insurance issuer 
     offers group health insurance coverage in connection with a 
     group health plan and takes an action in violation of any 
     provision of this subchapter, the group health plan shall not 
     be liable for such violation unless the plan caused such 
     violation.
       ``(g) Applicability.--The provisions of this section shall 
     apply to group health plans and health insurance issuers as 
     if included in--
       ``(1) subpart 2 of part A of title XXVII of the Public 
     Health Service Act;
       ``(2) the first subpart 3 of part B of title XXVII of the 
     Public Health Service Act (relating to other requirements); 
     and
       ``(3) subchapter B of chapter 100 of the Internal Revenue 
     Code of 1986.
       ``(h) Nonapplication of Certain Provision.--Only for 
     purposes of applying the requirements of this section under 
     section 714 of the Employee Retirement Income Security Act of 
     1974 (as added by section 301 of this Act), sections 2707 and 
     2753 of the Public Health Service Act (as added by sections 
     201 and 202 of this Act), and section 9813 of the Internal 
     Revenue Code of 1986 (as added by section 401 of this Act)--
       ``(1) section 2721(b)(2) of the Public Health Service Act 
     and section 9831(a)(1) of the Internal Revenue Code of 1986 
     shall not apply to the provisions of this section; and
       ``(2) with respect to limited scope dental benefits, 
     subparagraph (A) of section 733(c)(2) of the Employee 
     Retirement Income Security Act of 1974, subparagraph (A) of 
     section 2791(c)(2) of the Public Health Service Act, and 
     subparagraph (A) of section 9832(c)(2) of the Internal 
     Revenue Code of 1986 shall not apply to the provisions of 
     this section.
       ``(i) No Impact on Social Security Trust Fund.--
       ``(1) In general.--Nothing in this section shall be 
     construed to alter or amend the Social Security Act (or any 
     regulation promulgated under that Act).
       ``(2) Transfers.--

[[Page 15536]]

       ``(A) Estimate of secretary.--The Secretary of the Treasury 
     shall annually estimate the impact that the enactment of this 
     section has on the income and balances of the trust funds 
     established under section 201 of the Social Security Act (42 
     U.S.C. 401).
       ``(B) Transfer of funds.--If, under subparagraph (A), the 
     Secretary of the Treasury estimates that the enactment of 
     this section has a negative impact on the income and balances 
     of the trust funds established under section 201 of the 
     Social Security Act (42 U.S.C. 401), the Secretary shall 
     transfer, not less frequently than quarterly, from the 
     general revenues of the Federal Government an amount 
     sufficient so as to ensure that the income and balances of 
     such trust funds are not reduced as a result of the enactment 
     of such section.
       ``(j) Limitation on actions.--
       ``(1) In general.--Except as provided for in paragraph (2), 
     no action may be brought under subsection (a)(1)(B), (a)(2), 
     or (a)(3) of section 502 by a participant or beneficiary 
     seeking relief based on the application of any provision in 
     this section.
       ``(2) Permissible actions.--An action may be brought under 
     subsection (a)(1)(B), (a)(2), or (a)(3) of section 502 by a 
     participant or beneficiary seeking relief based on the 
     application of this section to the individual circumstances 
     of that participant or beneficiary; except that--
       ``(A) such an action may not be brought or maintained as a 
     class action; and
       ``(B) in such an action relief may only provide for the 
     provision of (or payment for) benefits, items, or services 
     denied to the individual participant or beneficiary involved 
     (and for attorney's fees and the costs of the action, at the 
     discretion of the court) and shall not provide for any other 
     relief to the participant or beneficiary or for any relief to 
     any other person.
       ``(3) Rule of construction.--Nothing in this subsection 
     shall be construed as affecting any action brought by the 
     Secretary.
       ``(k) Effective Date.--The provisions of this section shall 
     apply to group health plans for plan years beginning after, 
     and to health insurance issuers for coverage offered or sold 
     after, October 1, 2000.''.
       (b) Information Requirements.--
       (1) Information from group health plans.--Section 1862(b) 
     of the Social Security Act (42 U.S.C. 1395y(b)) is amended by 
     adding at the end the following:
       ``(7) Information from group health plans.--
       ``(A) Provision of information by group health plans.--The 
     administrator of a group health plan subject to the 
     requirements of paragraph (1) shall provide to the Secretary 
     such of the information elements described in subparagraph 
     (C) as the Secretary specifies, and in such manner and at 
     such times as the Secretary may specify (but not more 
     frequently than 4 times per year), with respect to each 
     individual covered under the plan who is entitled to any 
     benefits under this title.
       ``(B) Provision of information by employers and employee 
     organizations.--An employer (or employee organization) that 
     maintains or participates in a group health plan subject to 
     the requirements of paragraph (1) shall provide to the 
     administrator of the plan such of the information elements 
     required to be provided under subparagraph (A), and in such 
     manner and at such times as the Secretary may specify, at a 
     frequency consistent with that required under subparagraph 
     (A) with respect to each individual described in subparagraph 
     (A) who is covered under the plan by reason of employment 
     with that employer or membership in the organization.
       ``(C) Information elements.--The information elements 
     described in this subparagraph are the following:
       ``(i) Elements concerning the individual.--

       ``(I) The individual's name.
       ``(II) The individual's date of birth.
       ``(III) The individual's sex.
       ``(IV) The individual's social security insurance number.
       ``(V) The number assigned by the Secretary to the 
     individual for claims under this title.
       ``(VI) The family relationship of the individual to the 
     person who has or had current or employment status with the 
     employer.

       ``(ii) Elements concerning the family member with current 
     or former employment status.--

       ``(I) The name of the person in the individual's family who 
     has current or former employment status with the employer.
       ``(II) That person's social security insurance number.
       ``(III) The number or other identifier assigned by the plan 
     to that person.
       ``(IV) The periods of coverage for that person under the 
     plan.

       ``(V) The employment status of that person (current or 
     former) during those periods of coverage.
       ``(VI) The classes (of that person's family members) 
     covered under the plan.

       ``(iii) Plan elements.--

       ``(I) The items and services covered under the plan.
       ``(II) The name and address to which claims under the plan 
     are to be sent.

       ``(iv) Elements concerning the employer.--

       ``(I) The employer's name.
       ``(II) The employer's address.
       ``(III) The employer identification number of the employer.

       ``(D) Use of identifiers.--The administrator of a group 
     health plan shall utilize a unique identifier for the plan in 
     providing information under subparagraph (A) and in other 
     transactions, as may be specified by the Secretary, related 
     to the provisions of this subsection. The Secretary may 
     provide to the administrator the unique identifier described 
     in the preceding sentence.
       ``(E) Penalty for noncompliance.--Any entity that knowingly 
     and willfully fails to comply with a requirement imposed by 
     the previous subparagraphs shall be subject to a civil money 
     penalty not to exceed $1,000 for each incident of such 
     failure. The provisions of section 1128A (other than 
     subsections (a) and (b)) shall apply to a civil money penalty 
     under the previous sentence in the same manner as those 
     provisions apply to a penalty or proceeding under section 
     1128A(a).''.
       (2) Effective date.--The amendment made by paragraph (1) 
     shall take effect 180 days after the date of the enactment of 
     this Act.
       (c) Modification of Installment Method and Repeal of 
     Installment Method for Accrual Method Taxpayers.--
       (1) Repeal of installment method for accrual basis 
     taxpayers.--
       (A) In general.--Subsection (a) of section 453 of the 
     Internal Revenue Code of 1986 (relating to installment 
     method) is amended to read as follows:
       ``(a) Use of Installment Method.--
       ``(1) In general.--Except as otherwise provided in this 
     section, income from an installment sale shall be taken into 
     account for purposes of this title under the installment 
     method.
       ``(2) Accrual method taxpayer.--The installment method 
     shall not apply to income from an installment sale if such 
     income would be reported under an accrual method of 
     accounting without regard to this section. The preceding 
     sentence shall not apply to a disposition described in 
     subparagraph (A) or (B) of subsection (l)(2).''
       (B) Conforming amendments.--Sections 453(d)(1), 453(i)(1), 
     and 453(k) of such Act are each amended by striking ``(a)'' 
     each place it appears and inserting ``(a)(1)''.
       (2) Modification of pledge rules.--Paragraph (4) of section 
     453A(d) of such Act (relating to pledges, etc., of 
     installment obligations) is amended by adding at the end the 
     following: ``A payment shall be treated as directly secured 
     by an interest in an installment obligation to the extent an 
     arrangement allows the taxpayer to satisfy all or a portion 
     of the indebtedness with the installment obligation.''
       (3) Effective date.--The amendments made by this subsection 
     shall apply to sales or other dispositions occurring on or 
     after the date of the enactment of this Act.

                          ____________________