[Congressional Record Volume 145, Number 88 (Monday, June 21, 1999)]
[Senate]
[Pages S7338-S7367]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                          AMENDMENTS SUBMITTED

                                 ______
                                 

   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
               RELATED AGENCIES APPROPRIATIONS ACT, 2000

                                 ______
                                 

                GRAHAM (AND HOLLINGS) AMENDMENT NO. 700

  (Ordered to lie on the table.)
  Mr. GRAHAM (for himself and Mr. Hollings) submitted an amendment 
intended to be proposed by them to the bill (S. 1233) making 
appropriations for Agriculture, Rural Development, Food and Drug 
Administration, and Related Agencies programs for the fiscal year 
ending September 30, 2000, and for other purposes; as follows:

       On page 76, between lines 6 and 7, insert the following:
       Sec. 7__. Indication of Country of Origin of Imported 
     Perishable Agricultural Commodities.--(a) Definitions.--In 
     this section, the terms ``perishable agricultural commodity'' 
     and ``retailer'' have the meanings given the terms in section 
     1(b) of the Perishable Agricultural Commodities Act, 1930 (7 
     U.S.C. 499a(b)).
       (b) Notice of Country of Origin Required.--A retailer of a 
     perishable agricultural commodity imported into the United 
     States shall inform consumers, at the final point of sale of 
     the perishable agricultural commodity to consumers, of the 
     country of origin of the perishable agricultural commodity.
       (c) Method of Notification.--
       (1) In general.--The information required by subsection (b) 
     may be provided to consumers by means of a label, stamp, 
     mark, placard, or other clear and visible sign on the 
     imported perishable agricultural commodity or on the package, 
     display, holding unit, or bin containing the commodity at the 
     final point of sale to consumers.
       (2) Labeled commodities.--If the imported perishable 
     agricultural commodity is already individually labeled 
     regarding country of origin by the packer, importer, or 
     another person, the retailer shall not be required to provide 
     any additional information to comply with this section.
       (d) Violations.--If a retailer fails to indicate the 
     country of origin of an imported perishable agricultural 
     commodity as required by subsection (b), the Secretary of 
     Agriculture may impose a monetary penalty on the retailer in 
     an amount not to exceed--
       (1) $1,000 for the first day on which the violation occurs; 
     and
       (2) $250 for each day on which the same violation 
     continues.
       (e) Deposit of Funds.--Amounts collected under subsection 
     (d) shall be deposited in the Treasury of the United States 
     as miscellaneous receipts.
       (f) Application of Section.--This section shall apply with 
     respect to a perishable agricultural commodity imported into 
     the United States after the end of the 6-month period 
     beginning on the date of the enactment of this section.
                                 ______
                                 

                       ABRAHAM AMENDMENT NO. 701

  (Ordered to lie on the table.)
  Mr. ABRAHAM submitted an amendment intended to be proposed by him to 
the bill, S. 1233, supra; as follows:

       On page 13, line 14, before the semicolon insert the 
     following: ``, of which not less than $600,000 shall be used 
     to0 provide a special grant for bovine tuberculosis research 
     at Michigan State University''.
                                 ______
                                 

                       DASCHLE AMENDMENT NO. 702

  Mr. DORGAN (for Mr. Daschle) proposed an amendment to the bill, S. 
1233, supra; as follows:

       At the appropriate place, insert the following:

                   TITLE __--PATIENTS' BILL OF RIGHTS

     SEC. __01. SHORT TITLE.

       This title may be cited as the ``Patients' Bill of Rights 
     Act of 1999''.

              Subtitle A--Health Insurance Bill of Rights

                       CHAPTER 1--ACCESS TO CARE

     SEC. __101. ACCESS TO EMERGENCY CARE.

       (a) Coverage of Emergency 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 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 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 
     2701 of the Public Health Service Act, section 701 of the 
     Employee Retirement Income Security Act of 1974, or section 
     9801 of the Internal Revenue Code of 1986, 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.

[[Page S7339]]

       (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 under health insurance coverage offered 
     by a health insurance issuer, 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 an enrollee after an 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.

     SEC. __102. OFFERING OF CHOICE OF COVERAGE OPTIONS UNDER 
                   GROUP HEALTH PLANS.

       (a) Requirement.--
       (1) Offering of point-of-service coverage option.--Except 
     as provided in paragraph (2), if a group health plan (or 
     health insurance coverage offered by a health insurance 
     issuer in connection with a group health plan) provides 
     benefits only through participating health care providers, 
     the plan or issuer 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 or 
     coverage and at such other times as the plan or issuer offers 
     the participant a choice of coverage options.
       (2) Exception.--Paragraph (1) shall not apply with respect 
     to a participant in a group health plan if the plan offers 
     the participant--
       (A) a choice of health insurance coverage; and
       (B) one or more coverage options that do not provide 
     benefits only through participating health care providers.
       (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 or health 
     insurance issuer, coverage of such benefits when provided by 
     a nonparticipating health care provider. Such coverage need 
     not include coverage of providers that the plan or issuer 
     excludes because of fraud, quality, or similar reasons.
       (c) Construction.--Nothing in this section shall be 
     construed--
       (1) as requiring coverage for benefits for a particular 
     type of health care provider;
       (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; or
       (3) as preventing a group health plan or health insurance 
     issuer from imposing higher premiums or cost-sharing on a 
     participant for the exercise of a point-of-service coverage 
     option.
       (d) No Requirement for Guaranteed Availability.--If a 
     health insurance issuer offers health insurance coverage that 
     includes point-of-service coverage with respect to an 
     employer solely in order to meet the requirement of 
     subsection (a), nothing in section 2711(a)(1)(A) of the 
     Public Health Service Act shall be construed as requiring the 
     offering of such coverage with respect to another employer.

     SEC. __103. CHOICE OF PROVIDERS.

       (a) Primary Care.--A group health plan, and a health 
     insurance issuer that offers health insurance coverage, shall 
     permit each participant, beneficiary, and enrollee to receive 
     primary care from any participating primary care provider who 
     is available to accept such individual.
       (b) Specialists.--
       (1) In general.--Subject to paragraph (2), a group health 
     plan and a health insurance issuer that offers health 
     insurance coverage shall permit each participant, 
     beneficiary, or enrollee to receive medically necessary or 
     appropriate specialty care, pursuant to appropriate referral 
     procedures, from any qualified participating health care 
     provider who is available to accept such individual for such 
     care.
       (2) Limitation.--Paragraph (1) shall not apply to specialty 
     care if the plan or issuer clearly informs participants, 
     beneficiaries, and enrollees of the limitations on choice of 
     participating providers with respect to such care.

     SEC. __104. ACCESS TO SPECIALTY CARE.

       (a) Obstetrical and Gynecological Care.--
       (1) In general.--If a group health plan, or a health 
     insurance issuer in connection with the provision of health 
     insurance coverage, requires or provides for a participant, 
     beneficiary, or enrollee to designate a participating primary 
     care provider--
       (A) the plan or issuer shall permit such an individual who 
     is a female to designate a participating physician who 
     specializes in obstetrics and gynecology as the individual's 
     primary care provider; and
       (B) if such an individual has not designated such a 
     provider as a primary care provider, the plan or issuer--
       (i) may not require authorization or a referral by the 
     individual's primary care provider or otherwise for coverage 
     of routine gynecological care (such as preventive women's 
     health examinations) and pregnancy-related services provided 
     by a participating health care professional who specializes 
     in obstetrics and gynecology to the extent such care is 
     otherwise covered, and
       (ii) may treat the ordering of other gynecological care by 
     such a participating health professional as the authorization 
     of the primary care provider with respect to such care under 
     the plan or coverage.
       (2) Construction.--Nothing in paragraph (1)(B)(ii) shall 
     waive any requirements of coverage relating to medical 
     necessity or appropriateness with respect to coverage of 
     gynecological care so ordered.
       (b) Specialty Care.--
       (1) Specialty care for covered services.--
       (A) In general.--If--
       (i) an individual is a participant or beneficiary under a 
     group health plan or an enrollee who is covered under health 
     insurance coverage offered by a health insurance issuer,
       (ii) the individual has a condition or disease of 
     sufficient seriousness and complexity to require treatment by 
     a specialist, and
       (iii) benefits for such treatment are provided under the 
     plan or coverage,

     the plan or issuer shall make or provide for a referral to a 
     specialist who is available and accessible to provide the 
     treatment for such condition or disease.
       (B) Specialist defined.--For purposes of this subsection, 
     the term ``specialist'' means, with respect to a condition, a 
     health care practitioner, facility, or center (such as a 
     center of excellence) that has adequate expertise through 
     appropriate training and experience (including, in the case 
     of a child, appropriate pediatric expertise) to provide high 
     quality care in treating the condition.
       (C) Care under referral.--A group health plan or health 
     insurance issuer may require that the care provided to an 
     individual pursuant to such referral under subparagraph (A) 
     be--
       (i) pursuant to a treatment plan, only if the treatment 
     plan is developed by the specialist and approved by the plan 
     or issuer, in consultation with the designated primary care 
     provider or specialist and the individual (or the 
     individual's designee), and
       (ii) in accordance with applicable quality assurance and 
     utilization review standards of the plan or issuer.

     Nothing in this subsection shall be construed as preventing 
     such a treatment plan for an individual from requiring a 
     specialist to provide the primary care provider with regular 
     updates on the specialty care provided, as well as all 
     necessary medical information.
       (D) Referrals to participating providers.--A group health 
     plan or health insurance issuer is not required under 
     subparagraph (A) to provide for a referral to a specialist 
     that is not a participating provider, unless the plan or 
     issuer does not have an appropriate specialist that is 
     available and accessible to treat the individual's condition 
     and that is a participating provider with respect to such 
     treatment.
       (E) Treatment of nonparticipating providers.--If a plan or 
     issuer refers an individual to a nonparticipating specialist 
     pursuant to subparagraph (A), services provided pursuant to 
     the approved treatment plan (if any) shall be provided at no 
     additional cost to the individual beyond what the individual 
     would otherwise pay for services received by such a 
     specialist that is a participating provider.
       (2) Specialists as primary care providers.--
       (A) In general.--A group health plan, or a health insurance 
     issuer, in connection with the provision of health insurance 
     coverage, shall have a procedure by which an individual who 
     is a participant, beneficiary, or enrollee and who has an 
     ongoing special condition (as defined in subparagraph (C)) 
     may receive a referral to a specialist for such condition who 
     shall be responsible for and capable of providing and 
     coordinating the individual's primary and specialty care. If 
     such an individual's care would most appropriately be 
     coordinated by such a specialist, such plan or issuer shall 
     refer the individual to such specialist.
       (B) Treatment as primary care provider.--Such specialist 
     shall be permitted to treat the individual without a referral 
     from the individual's primary care provider and may authorize 
     such referrals, procedures, tests, and other medical services 
     as the individual's primary care provider would otherwise be 
     permitted to provide or authorize, subject to the terms of 
     the treatment plan (referred to in paragraph (1)(C)(i)).
       (C) Ongoing special condition defined.--In this paragraph, 
     the term ``special condition'' means a condition or disease 
     that--
       (i) is life-threatening, degenerative, or disabling, and
       (ii) requires specialized medical care over a prolonged 
     period of time.

[[Page S7340]]

       (D) Terms of referral.--The provisions of subparagraphs (C) 
     through (E) of paragraph (1) apply with respect to referrals 
     under subparagraph (A) of this paragraph in the same manner 
     as they apply to referrals under paragraph (1)(A).
       (3) Standing referrals.--
       (A) In general.--A group health plan, and a health 
     insurance issuer in connection with the provision of health 
     insurance coverage, shall have a procedure by which an 
     individual who is a participant, beneficiary, or enrollee and 
     who has a condition that requires ongoing care from a 
     specialist may receive a standing referral to such specialist 
     for treatment of such condition. If the plan or issuer, or if 
     the primary care provider in consultation with the medical 
     director of the plan or issuer and the specialist (if any), 
     determines that such a standing referral is appropriate, the 
     plan or issuer shall make such a referral to such a 
     specialist.
       (B) Terms of referral.--The provisions of subparagraphs (C) 
     through (E) of paragraph (1) apply with respect to referrals 
     under subparagraph (A) of this paragraph in the same manner 
     as they apply to referrals under paragraph (1)(A).

     SEC. __105. CONTINUITY OF CARE.

       (a) In General.--
       (1) Termination of provider.--If a contract between a group 
     health plan, or a health insurance issuer in connection with 
     the provision of health insurance coverage, and a health care 
     provider is terminated (as defined in paragraph (3)), or 
     benefits or coverage provided by a health care provider are 
     terminated because of a change in the terms of provider 
     participation in a group health plan, and an individual who 
     is a participant, beneficiary, or enrollee in the plan or 
     coverage is undergoing a course of treatment from the 
     provider at the time of such termination, the plan or issuer 
     shall--
       (A) notify the individual on a timely basis of such 
     termination, and
       (B) subject to subsection (c), permit the individual to 
     continue or be covered with respect to the course of 
     treatment with the provider during a transitional period 
     (provided under subsection (b)).
       (2) Treatment of termination of contract with health 
     insurance issuer.--If a contract for the provision of health 
     insurance coverage between a group health plan and a health 
     insurance issuer is terminated and, as a result of such 
     termination, coverage of services of a health care provider 
     is terminated with respect to an individual, the provisions 
     of paragraph (1) (and the succeeding provisions of this 
     section) shall apply under the plan in the same manner as if 
     there had been a contract between the plan and the provider 
     that had been terminated, but only with respect to benefits 
     that are covered under the plan after the contract 
     termination.
       (3) Termination.--In this section, the term ``terminated'' 
     includes, with respect to a contract, the expiration or 
     nonrenewal of the contract, but does not include a 
     termination of the contract by the plan or issuer for failure 
     to meet applicable quality standards or for fraud.
       (b) Transitional Period.--
       (1) In general.--Except as provided in paragraphs (2) 
     through (4), the transitional period under this subsection 
     shall extend for at least 90 days from the date of the notice 
     described in subsection (a)(1)(A) of the provider's 
     termination.
       (2) Institutional care.--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.--If--
       (A) a participant, beneficiary, or enrollee 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 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.--If--
       (A) a participant, beneficiary, or enrollee was determined 
     to be terminally ill (as determined under section 
     1861(dd)(3)(A) of the Social Security Act) at the time of 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 extend 
     for the remainder of the individual's life for care directly 
     related to the treatment of the terminal illness.
       (c) Permissible Terms and Conditions.--A group health plan 
     or health insurance issuer may condition coverage of 
     continued treatment by a provider under subsection (a)(1)(B) 
     upon the provider agreeing to the following terms and 
     conditions:
       (1) The provider agrees to accept reimbursement from the 
     plan or issuer and individual involved (with respect to cost-
     sharing) at the rates applicable prior to the start of the 
     transitional period as payment in full (or, in the case 
     described in subsection (a)(2), at the rates applicable under 
     the replacement plan or issuer after the date of the 
     termination of the contract with the health insurance issuer) 
     and not to impose cost-sharing with respect to the individual 
     in an amount that would exceed the cost-sharing that could 
     have been imposed if the contract referred to in subsection 
     (a)(1) had not been terminated.
       (2) The provider agrees to adhere to the quality assurance 
     standards of the plan or issuer responsible for payment under 
     paragraph (1) and to provide to such plan or issuer necessary 
     medical information related to the care provided.
       (3) The provider agrees otherwise to adhere to such plan's 
     or issuer'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 or issuer.
       (d) 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.

     SEC. __106. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 
                   APPROVED CLINICAL TRIALS.

       (a) Coverage.--
       (1) In general.--If a group health plan, or health 
     insurance issuer that is providing health insurance coverage, 
     provides coverage to a qualified individual (as defined in 
     subsection (b)), the plan or issuer--
       (A) may not deny the individual participation in the 
     clinical trial referred to in subsection (b)(2);
       (B) subject to subsection (c), may not deny (or limit or 
     impose additional conditions on) the coverage of routine 
     patient costs for items and services furnished in connection 
     with participation in the trial; and
       (C) may not discriminate against the individual on the 
     basis of the enrollee's participation in such trial.
       (2) Exclusion of certain costs.--For purposes of paragraph 
     (1)(B), routine patient costs do not include the cost of the 
     tests or measurements conducted primarily for the purpose of 
     the clinical trial involved.
       (3) Use of in-network providers.--If one or more 
     participating providers is participating in a clinical trial, 
     nothing in paragraph (1) shall be construed as preventing a 
     plan or issuer from requiring that a qualified individual 
     participate in the trial through such a participating 
     provider if the provider will accept the individual as a 
     participant in the trial.
       (b) Qualified Individual Defined.--For purposes of 
     subsection (a), the term ``qualified individual'' means an 
     individual who is a participant or beneficiary in a group 
     health plan, or who is an enrollee under health insurance 
     coverage, and who meets the following conditions:
       (1)(A) The individual has a life-threatening or serious 
     illness for which no standard treatment is effective.
       (B) The individual is eligible to participate in an 
     approved clinical trial according to the trial protocol with 
     respect to treatment of such illness.
       (C) The individual's participation in the trial offers 
     meaningful potential for significant clinical benefit for the 
     individual.
       (2) Either--
       (A) the referring physician is a participating health care 
     professional and has concluded that the individual's 
     participation in such trial would be appropriate based upon 
     the individual meeting the conditions described in paragraph 
     (1); or
       (B) the participant, beneficiary, or enrollee provides 
     medical and scientific information establishing that the 
     individual's participation in such trial would be appropriate 
     based upon the individual meeting the conditions described in 
     paragraph (1).
       (c) Payment.--
       (1) In general.--Under this section a group health plan or 
     health insurance issuer shall provide for payment for routine 
     patient costs described in subsection (a)(2) but is not 
     required to pay for costs of items and services that are 
     reasonably expected (as determined by the Secretary) to be 
     paid for by the sponsors of an approved clinical trial.
       (2) Payment rate.--In the case of covered items and 
     services provided by--
       (A) a participating provider, the payment rate shall be at 
     the agreed upon rate, or
       (B) a nonparticipating provider, the payment rate shall be 
     at the rate the plan or issuer would normally pay for 
     comparable services under subparagraph (A).
       (d) Approved Clinical Trial Defined.--
       (1) In general.--In this section, the term ``approved 
     clinical trial'' means a clinical research study or clinical 
     investigation approved and funded (which may include funding 
     through in-kind contributions) by one or more of the 
     following:
       (A) The National Institutes of Health.
       (B) A cooperative group or center of the National 
     Institutes of Health.
       (C) Either of the following if the conditions described in 
     paragraph (2) are met:
       (i) The Department of Veterans Affairs.
       (ii) The Department of Defense.
       (2) Conditions for departments.--The conditions described 
     in this paragraph, for a study or investigation conducted by 
     a Department, are that the study or investigation has been 
     reviewed and approved through a system of peer review that 
     the Secretary determines--
       (A) to be comparable to the system of peer review of 
     studies and investigations used by the National Institutes of 
     Health, and

[[Page S7341]]

       (B) assures unbiased review of the highest scientific 
     standards by qualified individuals who have no interest in 
     the outcome of the review.
       (e) Construction.--Nothing in this section shall be 
     construed to limit a plan's or issuer's coverage with respect 
     to clinical trials.

     SEC. __107. ACCESS TO NEEDED PRESCRIPTION DRUGS.

       (a) In General.--If a group health plan, or health 
     insurance issuer that offers health insurance coverage, 
     provides benefits with respect to prescription drugs but the 
     coverage limits such benefits to drugs included in a 
     formulary, the plan or issuer shall--
       (1) ensure participation of participating physicians and 
     pharmacists in the development of the formulary;
       (2) disclose to providers and, disclose upon request under 
     section __121(c)(6) to participants, beneficiaries, and 
     enrollees, the nature of the formulary restrictions; and
       (3) consistent with the standards for a utilization review 
     program under section __115, provide for exceptions from the 
     formulary limitation when a non-formulary alternative is 
     medically indicated.
       (b) Coverage of Approved Drugs and Medical Devices.--
       (1) In general.--A group health plan (or health insurance 
     coverage offered in connection with such a plan) that 
     provides any coverage of prescription drugs or medical 
     devices shall not deny coverage of such a drug or device on 
     the basis that the use is investigational, if the use--
       (A) in the case of a prescription drug--
       (i) is included in the labeling authorized by the 
     application in effect for the drug pursuant to subsection (b) 
     or (j) of section 505 of the Federal Food, Drug, and Cosmetic 
     Act, without regard to any postmarketing requirements that 
     may apply under such Act; or
       (ii) is included in the labeling authorized by the 
     application in effect for the drug under section 351 of the 
     Public Health Service Act, without regard to any 
     postmarketing requirements that may apply pursuant to such 
     section; or
       (B) in the case of a medical device, is included in the 
     labeling authorized by a regulation under subsection (d) or 
     (3) of section 513 of the Federal Food, Drug, and Cosmetic 
     Act, an order under subsection (f) of such section, or an 
     application approved under section 515 of such Act, without 
     regard to any postmarketing requirements that may apply under 
     such Act.
       (2) Construction.--Nothing in this subsection shall be 
     construed as requiring a group health plan (or health 
     insurance coverage offered in connection with such a plan) to 
     provide any coverage of prescription drugs or medical 
     devices.

     SEC. __108. ADEQUACY OF PROVIDER NETWORK.

       (a) In General.--Each group health plan, and each health 
     insurance issuer offering health insurance coverage, that 
     provides benefits, in whole or in part, through participating 
     health care providers shall have (in relation to the 
     coverage) a sufficient number, distribution, and variety of 
     qualified participating health care providers to ensure that 
     all covered health care services, including specialty 
     services, will be available and accessible in a timely manner 
     to all participants, beneficiaries, and enrollees under the 
     plan or coverage. This subsection shall only apply to a 
     plan's or issuer's application of restrictions on the 
     participation of health care providers in a network and shall 
     not be construed as requiring a plan or issuer to create or 
     establish new health care providers in an area.
       (b) Treatment of Certain Providers.--The qualified health 
     care providers under subsection (a) may include Federally 
     qualified health centers, rural health clinics, migrant 
     health centers, and other essential community providers 
     located in the service area of the plan or issuer and shall 
     include such providers if necessary to meet the standards 
     established to carry out such subsection.

     SEC. __109. NONDISCRIMINATION IN DELIVERY OF SERVICES.

       (a) Application to Delivery of Services.--Subject to 
     subsection (b), a group health plan, and health insurance 
     issuer in relation to health insurance coverage, may not 
     discriminate against a participant, beneficiary, or enrollee 
     in the delivery of health care services consistent with the 
     benefits covered under the plan or coverage or as required by 
     law based on race, color, ethnicity, national origin, 
     religion, sex, age, mental or physical disability, sexual 
     orientation, genetic information, or source of payment.
       (b) Construction.--Nothing in subsection (a) shall be 
     construed as relating to the eligibility to be covered, or 
     the offering (or guaranteeing the offer) of coverage, under a 
     plan or health insurance coverage, the application of any 
     pre-existing condition exclusion consistent with applicable 
     law, or premiums charged under such plan or coverage. 
     Pursuant to section __192(b), except as provided in section 
     __152, nothing in this subtitle shall be construed as 
     requiring a group health plan or health insurance issuer to 
     provide specific benefits under the terms of such plan or 
     coverage.

                      CHAPTER 2--QUALITY ASSURANCE

     SEC. __111. INTERNAL QUALITY ASSURANCE PROGRAM.

       (a) Requirement.--A group health plan, and a health 
     insurance issuer that offers health insurance coverage, shall 
     establish and maintain an ongoing, internal quality assurance 
     and continuous quality improvement program that meets the 
     requirements of subsection (b).
       (b) Program Requirements.--The requirements of this 
     subsection for a quality improvement program of a plan or 
     issuer are as follows:
       (1) Administration.--The plan or issuer has a separate 
     identifiable unit with responsibility for administration of 
     the program.
       (2) Written plan.--The plan or issuer has a written plan 
     for the program that is updated annually and that specifies 
     at least the following:
       (A) The activities to be conducted.
       (B) The organizational structure.
       (C) The duties of the medical director.
       (D) Criteria and procedures for the assessment of quality.
       (3) Systematic review.--The program provides for systematic 
     review of the type of health services provided, consistency 
     of services provided with good medical practice, and patient 
     outcomes.
       (4) Quality criteria.--The program--
       (A) uses criteria that are based on performance and patient 
     outcomes where feasible and appropriate;
       (B) includes criteria that are directed specifically at 
     meeting the needs of at-risk populations and covered 
     individuals with chronic conditions or severe illnesses, 
     including gender-specific criteria and pediatric-specific 
     criteria where available and appropriate;
       (C) includes methods for informing covered individuals of 
     the benefit of preventive care and what specific benefits 
     with respect to preventive care are covered under the plan or 
     coverage; and
       (D) makes available to the public a description of the 
     criteria used under subparagraph (A).
       (5) System for reporting.--The program has procedures for 
     reporting of possible quality concerns by providers and 
     enrollees and for remedial actions to correct quality 
     problems, including written procedures for responding to 
     concerns and taking appropriate corrective action.
       (6) Data analysis.--The program provides, using data that 
     include the data collected under section __112, for an 
     analysis of the plan's or issuer's performance on quality 
     measures.
       (7) Drug utilization review.--The program provides for a 
     drug utilization review program in accordance with section 
     __114.
       (c) Deeming.--For purposes of subsection (a), the 
     requirements of--
       (1) subsection (b) (other than paragraph (5)) are deemed to 
     be met with respect to a health insurance issuer that is a 
     qualified health maintenance organization (as defined in 
     section 1310(c) of the Public Health Service Act); or
       (2) subsection (b) are deemed to be met with respect to a 
     health insurance issuer that is accredited by a national 
     accreditation organization that the Secretary certifies as 
     applying, as a condition of certification, standards at least 
     a stringent as those required for a quality improvement 
     program under subsection (b).
       (d) Variation Permitted.--The Secretary may provide for 
     variations in the application of the requirements of this 
     section to group health plans and health insurance issuers 
     based upon differences in the delivery system among such 
     plans and issuers as the Secretary deems appropriate.

     SEC. __112. COLLECTION OF STANDARDIZED DATA.

       (a) In General.--A group health plan and a health insurance 
     issuer that offers health insurance coverage shall collect 
     uniform quality data that include a minimum uniform data set 
     described in subsection (b).
       (b) Minimum Uniform Data Set.--The Secretary shall specify 
     (and may from time to time update) the data required to be 
     included in the minimum uniform data set under subsection (a) 
     and the standard format for such data. Such data shall 
     include at least--
       (1) aggregate utilization data;
       (2) data on the demographic characteristics of 
     participants, beneficiaries, and enrollees;
       (3) data on disease-specific and age-specific mortality 
     rates and (to the extent feasible) morbidity rates of such 
     individuals;
       (4) data on satisfaction (including satisfaction with 
     respect to services to children) of such individuals, 
     including data on voluntary disenrollment and grievances; and
       (5) data on quality indicators and health outcomes, 
     including, to the extent feasible and appropriate, data on 
     pediatric cases and on a gender-specific basis.
       (c) Availability.--A summary of the data collected under 
     subsection (a) shall be disclosed under section __121(b)(9). 
     The Secretary shall be provided access to all the data so 
     collected.
       (d) Variation Permitted.--The Secretary may provide for 
     variations in the application of the requirements of this 
     section to group health plans and health insurance issuers 
     based upon differences in the delivery system among such 
     plans and issuers as the Secretary deems appropriate.
       (e) Exception for Non-Medical, Religious Care Providers.--
     The requirements of subsection (a), insofar as they may apply 
     to a provider of health care, do not apply to a provider that 
     provides no medical care and that provides only a religious 
     method of healing or religious nonmedical nursing care.

[[Page S7342]]



     SEC. __113. PROCESS FOR SELECTION OF PROVIDERS.

       (a) In General.--A group health plan and a health insurance 
     issuer that offers health insurance coverage shall, if it 
     provides benefits through participating health care 
     professionals, have a written process for the selection of 
     participating health care professionals, including minimum 
     professional requirements.
       (b) Verification of Background.--Such process shall include 
     verification of a health care provider's license and a 
     history of suspension or revocation.
       (c) Restriction.--Such process shall not use a high-risk 
     patient base or location of a provider in an area with 
     residents with poorer health status as a basis for excluding 
     providers from participation.
       (d) Nondiscrimination Based on Licensure.--
       (1) In general.--Such process shall not discriminate with 
     respect to participation or indemnification as to any 
     provider who is acting within the scope of the provider's 
     license or certification under applicable State law, solely 
     on the basis of such license or certification.
       (2) Construction.--Paragraph (1) shall not be construed--
       (A) as requiring the coverage under a plan or coverage of 
     particular benefits or services or to prohibit a plan or 
     issuer from including providers only to the extent necessary 
     to meet the needs of the plan's or issuer's participants, 
     beneficiaries, or enrollees or from establishing any measure 
     designed to maintain quality and control costs consistent 
     with the responsibilities of the plan or issuer; or
       (B) to override any State licensure or scope-of-practice 
     law.
       (e) General Nondiscrimination.--
       (1) In general.--Subject to paragraph (2), such process 
     shall not discriminate with respect to selection of a health 
     care professional to be a participating health care provider, 
     or with respect to the terms and conditions of such 
     participation, based on the professional's race, color, 
     religion, sex, national origin, age, sexual orientation, or 
     disability (consistent with the Americans with Disabilities 
     Act of 1990).
       (2) Rules.--The appropriate Secretary may establish such 
     definitions, rules, and exceptions as may be appropriate to 
     carry out paragraph (1), taking into account comparable 
     definitions, rules, and exceptions in effect under 
     employment-based nondiscrimination laws and regulations that 
     relate to each of the particular bases for discrimination 
     described in such paragraph.

     SEC. __114. DRUG UTILIZATION PROGRAM.

       A group health plan, and a health insurance issuer that 
     provides health insurance coverage, that includes benefits 
     for prescription drugs shall establish and maintain, as part 
     of its internal quality assurance and continuous quality 
     improvement program under section __111, a drug utilization 
     program which--
       (1) encourages appropriate use of prescription drugs by 
     participants, beneficiaries, and enrollees and providers, and
       (2) takes appropriate action to reduce the incidence of 
     improper drug use and adverse drug reactions and 
     interactions.

     SEC. __115. STANDARDS FOR UTILIZATION REVIEW ACTIVITIES.

       (a) Compliance with Requirements.--
       (1) In general.--A group health plan, and a health 
     insurance issuer that provides health insurance coverage, 
     shall conduct utilization review activities in connection 
     with the provision of benefits under such plan or coverage 
     only in accordance with a utilization review program that 
     meets the requirements of this section.
       (2) Use of outside agents.--Nothing in this section shall 
     be construed as preventing a group health plan or health 
     insurance issuer from arranging through a contract or 
     otherwise for persons or entities to conduct utilization 
     review activities on behalf of the plan or issuer, so long as 
     such activities are conducted in accordance with a 
     utilization review program that meets the requirements of 
     this section.
       (3) Utilization review defined.--For purposes of this 
     section, the terms ``utilization review'' and ``utilization 
     review activities'' mean procedures used to monitor or 
     evaluate the clinical necessity, appropriateness, efficacy, 
     or efficiency of health care services, procedures or 
     settings, and includes prospective review, concurrent review, 
     second opinions, case management, discharge planning, or 
     retrospective review.
       (b) Written Policies and Criteria.--
       (1) Written policies.--A utilization review program shall 
     be conducted consistent with written policies and procedures 
     that govern all aspects of the program.
       (2) Use of written criteria.--
       (A) In general.--Such a program shall utilize written 
     clinical review criteria developed pursuant to the program 
     with the input of appropriate physicians. Such criteria shall 
     include written clinical review criteria described in section 
     __111(b)(4)(B).
       (B) Continuing use of standards in retrospective review.--
     If a health care service has been specifically pre-authorized 
     or approved for an enrollee under such a program, the program 
     shall not, pursuant to retrospective review, revise or modify 
     the specific standards, criteria, or procedures used for the 
     utilization review for procedures, treatment, and services 
     delivered to the enrollee during the same course of 
     treatment.
       (c) Conduct of Program Activities.--
       (1) Administration by health care professionals.--A 
     utilization review program shall be administered by qualified 
     health care professionals who shall oversee review decisions. 
     In this subsection, the term ``health care professional'' 
     means a physician or other health care practitioner licensed, 
     accredited, or certified to perform specified health services 
     consistent with State law.
       (2) Use of qualified, independent personnel.--
       (A) In general.--A utilization review program shall provide 
     for the conduct of utilization review activities only through 
     personnel who are qualified and, to the extent required, who 
     have received appropriate training in the conduct of such 
     activities under the program.
       (B) Peer review of sample of adverse clinical 
     determinations.--Such a program shall provide that clinical 
     peers (as defined in section __191(c)(2)) shall evaluate the 
     clinical appropriateness of at least a sample of adverse 
     clinical determinations.
       (C) Prohibition of contingent compensation arrangements.--
     Such a program shall not, with respect to utilization review 
     activities, permit or provide compensation or anything of 
     value to its employees, agents, or contractors in a manner 
     that--
       (i) provides incentives, direct or indirect, for such 
     persons to make inappropriate review decisions, or
       (ii) is based, directly or indirectly, on the quantity or 
     type of adverse determinations rendered.
       (D) Prohibition of conflicts.--Such a program shall not 
     permit a health care professional who provides health care 
     services to an individual to perform utilization review 
     activities in connection with the health care services being 
     provided to the individual.
       (3) Accessibility of review.--Such a program shall provide 
     that appropriate personnel performing utilization review 
     activities under the program are reasonably accessible by 
     toll-free telephone during normal business hours to discuss 
     patient care and allow response to telephone requests, and 
     that appropriate provision is made to receive and respond 
     promptly to calls received during other hours.
       (4) Limits on frequency.--Such a program shall not provide 
     for the performance of utilization review activities with 
     respect to a class of services furnished to an individual 
     more frequently than is reasonably required to assess whether 
     the services under review are medically necessary or 
     appropriate.
       (5) Limitation on information requests.--Under such a 
     program, information shall be required to be provided by 
     health care providers only to the extent it is necessary to 
     perform the utilization review activity involved.
       (d) Deadline for Determinations.--
       (1) Prior authorization services.--Except as provided in 
     paragraph (2), in the case of a utilization review activity 
     involving the prior authorization of health care items and 
     services for an individual, the utilization review program 
     shall make a determination concerning such authorization, and 
     provide notice of the determination to the individual or the 
     individual's designee and the individual's health care 
     provider by telephone and in printed form, as soon as 
     possible in accordance with the medical exigencies of the 
     cases, and in no event later than 3 business days after the 
     date of receipt of information that is reasonably necessary 
     to make such determination.
       (2) Continued care.--In the case of a utilization review 
     activity involving authorization for continued or extended 
     health care services for an individual, or additional 
     services for an individual undergoing a course of continued 
     treatment prescribed by a health care provider, the 
     utilization review program shall make a determination 
     concerning such authorization, and provide notice of the 
     determination to the individual or the individual's designee 
     and the individual's health care provider by telephone and in 
     printed form, as soon as possible in accordance with the 
     medical exigencies of the cases, and in no event later than 1 
     business day after the date of receipt of information that is 
     reasonably necessary to make such determination. Such notice 
     shall include, with respect to continued or extended health 
     care services, the number of extended services approved, the 
     new total of approved services, the date of onset of 
     services, and the next review date, if any.
       (3) Previously provided services.--In the case of a 
     utilization review activity involving retrospective review of 
     health care services previously provided for an individual, 
     the utilization review program shall make a determination 
     concerning such services, and provide notice of the 
     determination to the individual or the individual's designee 
     and the individual's health care provider by telephone and in 
     printed form, within 30 days of the date of receipt of 
     information that is reasonably necessary to make such 
     determination.
       (4) Reference to special rules for emergency services, 
     maintenance care, and post-stabilization care.--For waiver of 
     prior authorization requirements in certain cases involving 
     emergency services and maintenance care and post-
     stabilization care, see subsections (a)(1) and (b) of section 
     __101, respectively.
       (e) Notice of Adverse Determinations.--
       (1) In general.--Notice of an adverse determination under a 
     utilization review program shall be provided in printed form 
     and shall include--

[[Page S7343]]

       (A) the reasons for the determination (including the 
     clinical rationale);
       (B) instructions on how to initiate an appeal under section 
     __132; and
       (C) notice of the availability, upon request of the 
     individual (or the individual's designee) of the clinical 
     review criteria relied upon to make such determination.
       (2) Specification of any additional information.--Such a 
     notice shall also specify what (if any) additional necessary 
     information must be provided to, or obtained by, the person 
     making the determination in order to make a decision on such 
     an appeal.

     SEC. __116. HEALTH CARE QUALITY ADVISORY BOARD.

       (a) Establishment.--The President shall establish an 
     advisory board to provide information to Congress and the 
     administration on issues relating to quality monitoring and 
     improvement in the health care provided under group health 
     plans and health insurance coverage.
       (b) Number and Appointment.--The advisory board shall be 
     composed of the Secretary of Health and Human Services (or 
     the Secretary's designee), the Secretary of Labor (or the 
     Secretary's designee), and 20 additional members appointed by 
     the President, in consultation with the Majority and Minority 
     Leaders of the Senate and House of Representatives. The 
     members so appointed shall include individuals with expertise 
     in--
       (1) consumer needs;
       (2) education and training of health professionals;
       (3) health care services;
       (4) health plan management;
       (5) health care accreditation, quality assurance, 
     improvement, measurement, and oversight;
       (6) medical practice, including practicing physicians;
       (7) prevention and public health; and
       (8) public and private group purchasing for small and large 
     employers or groups.
       (c) Duties.--The advisory board shall--
       (1) identify, update, and disseminate measures of health 
     care quality for group health plans and health insurance 
     issuers, including network and non-network plans;
       (2) advise the Secretary on the development and maintenance 
     of the minimum data set in section __112(b); and
       (3) advise the Secretary on standardized formats for 
     information on group health plans and health insurance 
     coverage.
     The measures identified under paragraph (1) may be used on a 
     voluntary basis by such plans and issuers. In carrying out 
     paragraph (1), the advisory board shall consult and cooperate 
     with national health care standard setting bodies which 
     define quality indicators, the Agency for Health Care Policy 
     and Research, the Institute of Medicine, and other public and 
     private entities that have expertise in health care quality.
       (d) Report.--The advisory board shall provide an annual 
     report to Congress and the President on the quality of the 
     health care in the United States and national and regional 
     trends in health care quality. Such report shall include a 
     description of determinants of health care quality and 
     measurements of practice and quality variability within the 
     United States.
       (e) Secretarial Consultation.--In serving on the advisory 
     board, the Secretaries of Health and Human Services and Labor 
     (or their designees) shall consult with the Secretaries 
     responsible for other Federal health insurance and health 
     care programs.
       (f) Vacancies.--Any vacancy on the board shall be filled in 
     such manner as the original appointment. Members of the board 
     shall serve without compensation but shall be reimbursed for 
     travel, subsistence, and other necessary expenses incurred by 
     them in the performance of their duties. Administrative 
     support, scientific support, and technical assistance for the 
     advisory board shall be provided by the Secretary of Health 
     and Human Services.
       (g) Continuation.--Section 14(a)(2)(B) of the Federal 
     Advisory Committee Act (5 U.S.C. App.; relating to the 
     termination of advisory committees) shall not apply to the 
     advisory board.

                     CHAPTER 3--PATIENT INFORMATION

     SEC. __121. PATIENT INFORMATION.

       (a) Disclosure Requirement.--
       (1) Group health plans.--A group health plan shall--
       (A) provide to participants and beneficiaries at the time 
     of initial coverage under the plan (or the effective date of 
     this section, in the case of individuals who are participants 
     or beneficiaries as of such date), and at least annually 
     thereafter, the information described in subsection (b) in 
     printed form;
       (B) provide to participants and beneficiaries, within a 
     reasonable period (as specified by the appropriate Secretary) 
     before or after the date of significant changes in the 
     information described in subsection (b), information in 
     printed form on such significant changes; and
       (C) upon request, make available to participants and 
     beneficiaries, the applicable authority, and prospective 
     participants and beneficiaries, the information described in 
     subsection (b) or (c) in printed form.
       (2) Health insurance issuers.--A health insurance issuer in 
     connection with the provision of health insurance coverage 
     shall--
       (A) provide to individuals enrolled under such coverage at 
     the time of enrollment, and at least annually thereafter, the 
     information described in subsection (b) in printed form;
       (B) provide to enrollees, within a reasonable period (as 
     specified by the appropriate Secretary) before or after the 
     date of significant changes in the information described in 
     subsection (b), information in printed form on such 
     significant changes; and
       (C) upon request, make available to the applicable 
     authority, to individuals who are prospective enrollees, and 
     to the public the information described in subsection (b) or 
     (c) in printed form.
       (b) Information Provided.--The information described in 
     this subsection with respect to a group health plan or health 
     insurance coverage offered by a health insurance issuer 
     includes the following:
       (1) Service area.--The service area of the plan or issuer.
       (2) Benefits.--Benefits offered under the plan or coverage, 
     including--
       (A) covered benefits, including benefit limits and coverage 
     exclusions;
       (B) cost sharing, such as deductibles, coinsurance, and 
     copayment amounts, including any liability for balance 
     billing, any maximum limitations on out of pocket expenses, 
     and the maximum out of pocket costs for services that are 
     provided by non participating providers or that are furnished 
     without meeting the applicable utilization review 
     requirements;
       (C) the extent to which benefits may be obtained from 
     nonparticipating providers;
       (D) the extent to which a participant, beneficiary, or 
     enrollee may select from among participating providers and 
     the types of providers participating in the plan or issuer 
     network;
       (E) process for determining experimental coverage; and
       (F) use of a prescription drug formulary.
       (3) Access.--A description of the following:
       (A) The number, mix, and distribution of providers under 
     the plan or coverage.
       (B) Out-of-network coverage (if any) provided by the plan 
     or coverage.
       (C) Any point-of-service option (including any supplemental 
     premium or cost-sharing for such option).
       (D) The procedures for participants, beneficiaries, and 
     enrollees to select, access, and change participating primary 
     and specialty providers.
       (E) The rights and procedures for obtaining referrals 
     (including standing referrals) to participating and 
     nonparticipating providers.
       (F) The name, address, and telephone number of 
     participating health care providers and an indication of 
     whether each such provider is available to accept new 
     patients.
       (G) Any limitations imposed on the selection of qualifying 
     participating health care providers, including any 
     limitations imposed under section __103(b)(2).
       (H) How the plan or issuer addresses the needs of 
     participants, beneficiaries, and enrollees and others who do 
     not speak English or who have other special communications 
     needs in accessing providers under the plan or coverage, 
     including the provision of information described in this 
     subsection and subsection (c) to such individuals and 
     including the provision of information in a language other 
     than English if 5 percent of the number of participants, 
     beneficiaries, and enrollees communicate in that language 
     instead of English.
       (4) Out-of-area coverage.--Out-of-area coverage provided by 
     the plan or issuer.
       (5) Emergency coverage.--Coverage of emergency services, 
     including--
       (A) the appropriate use of emergency services, including 
     use of the 911 telephone system or its local equivalent in 
     emergency situations and an explanation of what constitutes 
     an emergency situation;
       (B) the process and procedures of the plan or issuer for 
     obtaining emergency services; and
       (C) the locations of (i) emergency departments, and (ii) 
     other settings, in which plan physicians and hospitals 
     provide emergency services and post-stabilization care.
       (6) Percentage of premiums used for benefits (loss-
     ratios).--In the case of health insurance coverage only (and 
     not with respect to group health plans that do not provide 
     coverage through health insurance coverage), a description of 
     the overall loss-ratio for the coverage (as defined in 
     accordance with rules established or recognized by the 
     Secretary of Health and Human Services).
       (7) Prior authorization rules.--Rules regarding prior 
     authorization or other review requirements that could result 
     in noncoverage or nonpayment.
       (8) Grievance and appeals procedures.--All appeal or 
     grievance rights and procedures under the plan or coverage, 
     including the method for filing grievances and the time 
     frames and circumstances for acting on grievances and 
     appeals, who is the applicable authority with respect to the 
     plan or issuer, and the availability of assistance through an 
     ombudsman to individuals in relation to group health plans 
     and health insurance coverage.
       (9) Quality assurance.--A summary description of the data 
     on quality collected under section __112(a), including a 
     summary description of the data on satisfaction of 
     participants, beneficiaries, and enrollees (including data on 
     individual voluntary disenrollment and grievances and 
     appeals) described in section __112(b)(4).
       (10) Summary of provider financial incentives.--A summary 
     description of the information on the types of financial 
     payment incentives (described in section 1852(j)(4) of the 
     Social Security Act) provided by the plan or issuer under the 
     coverage.
       (11) Information on issuer.--Notice of appropriate mailing 
     addresses and telephone

[[Page S7344]]

     numbers to be used by participants, beneficiaries, and 
     enrollees in seeking information or authorization for 
     treatment.
       (12) Availability of information on request.--Notice that 
     the information described in subsection (c) is available upon 
     request.
       (c) Information Made Available Upon Request.--The 
     information described in this subsection is the following:
       (1) Utilization review activities.--A description of 
     procedures used and requirements (including circumstances, 
     time frames, and appeal rights) under any utilization review 
     program under section __115, including under any drug 
     formulary program under section __107.
       (2) Grievance and appeals information.--Information on the 
     number of grievances and appeals and on the disposition in 
     the aggregate of such matters.
       (3) Method of physician compensation.--An overall summary 
     description as to the method of compensation of participating 
     physicians, including information on the types of financial 
     payment incentives (described in section 1852(j)(4) of the 
     Social Security Act) provided by the plan or issuer under the 
     coverage.
       (4) Specific information on credentials of participating 
     providers.--In the case of each participating provider, a 
     description of the credentials of the provider.
       (5) Confidentiality policies and procedures.--A description 
     of the policies and procedures established to carry out 
     section __122.
       (6) Formulary restrictions.--A description of the nature of 
     any drug formula restrictions.
       (7) Participating provider list.--A list of current 
     participating health care providers.
       (d) Form of Disclosure.--
       (1) Uniformity.--Information required to be disclosed under 
     this section shall be provided in accordance with uniform, 
     national reporting standards specified by the Secretary, 
     after consultation with applicable State authorities, so that 
     prospective enrollees may compare the attributes of different 
     issuers and coverage offered within an area.
       (2) Information into handbook.--Nothing in this section 
     shall be construed as preventing a group health plan or 
     health insurance issuer from making the information under 
     subsections (b) and (c) available to participants, 
     beneficiaries, and enrollees through an enrollee handbook or 
     similar publication.
       (3) Updating participating provider information.--The 
     information on participating health care providers described 
     in subsection (b)(3)(C) shall be updated within such 
     reasonable period as determined appropriate by the Secretary. 
     Nothing in this section shall prevent an issuer from changing 
     or updating other information made available under this 
     section.
       (e) Construction.--Nothing in this section shall be 
     construed as requiring public disclosure of individual 
     contracts or financial arrangements between a group health 
     plan or health insurance issuer and any provider.

     SEC. __122. PROTECTION OF PATIENT CONFIDENTIALITY.

       Insofar as a group health plan, or a health insurance 
     issuer that offers health insurance coverage, maintains 
     medical records or other health information regarding 
     participants, beneficiaries, and enrollees, the plan or 
     issuer shall establish procedures--
       (1) to safeguard the privacy of any individually 
     identifiable enrollee information;
       (2) to maintain such records and information in a manner 
     that is accurate and timely, and
       (3) to assure timely access of such individuals to such 
     records and information.

     SEC. __123. HEALTH INSURANCE OMBUDSMEN.

       (a) In General.--Each State that obtains a grant under 
     subsection (c) shall provide for creation and operation of a 
     Health Insurance Ombudsman through a contract with a not-for-
     profit organization that operates independent of group health 
     plans and health insurance issuers. Such Ombudsman shall be 
     responsible for at least the following:
       (1) To assist consumers in the State in choosing among 
     health insurance coverage or among coverage options offered 
     within group health plans.
       (2) To provide counseling and assistance to enrollees 
     dissatisfied with their treatment by health insurance issuers 
     and group health plans in regard to such coverage or plans 
     and with respect to grievances and appeals regarding 
     determinations under such coverage or plans.
       (b) Federal Role.--In the case of any State that does not 
     provide for such an Ombudsman under subsection (a), the 
     Secretary shall provide for the creation and operation of a 
     Health Insurance Ombudsman through a contract with a not-for-
     profit organization that operates independent of group health 
     plans and health insurance issuers and that is responsible 
     for carrying out with respect to that State the functions 
     otherwise provided under subsection (a) by a Health Insurance 
     Ombudsman.
       (c) Authorization of Appropriations.--There are authorized 
     to be appropriated to the Secretary of Health and Human 
     Services such amounts as may be necessary to provide for 
     grants to States for contracts for Health Insurance Ombudsmen 
     under subsection (a) or contracts for such Ombudsmen under 
     subsection (b).
       (d) Construction.--Nothing in this section shall be 
     construed to prevent the use of other forms of enrollee 
     assistance.

              CHAPTER 4--GRIEVANCE AND APPEALS PROCEDURES

     SEC. __131. ESTABLISHMENT OF GRIEVANCE PROCESS.

       (a) Establishment of Grievance System.--
       (1) In general.--A group health plan, and a health 
     insurance issuer in connection with the provision of health 
     insurance coverage, shall establish and maintain a system to 
     provide for the presentation and resolution of oral and 
     written grievances brought by individuals who are 
     participants, beneficiaries, or enrollees, or health care 
     providers or other individuals acting on behalf of an 
     individual and with the individual's consent, regarding any 
     aspect of the plan's or issuer's services.
       (2) Scope.--The system shall include grievances regarding 
     access to and availability of services, quality of care, 
     choice and accessibility of providers, network adequacy, and 
     compliance with the requirements of this subtitle.
       (b) Grievance System.--Such system shall include the 
     following components with respect to individuals who are 
     participants, beneficiaries, or enrollees:
       (1) Written notification to all such individuals and 
     providers of the telephone numbers and business addresses of 
     the plan or issuer personnel responsible for resolution of 
     grievances and appeals.
       (2) A system to record and document, over a period of at 
     least 3 previous years, all grievances and appeals made and 
     their status.
       (3) A process providing for timely processing and 
     resolution of grievances.
       (4) Procedures for follow-up action, including the methods 
     to inform the person making the grievance of the resolution 
     of the grievance.
       (5) Notification to the continuous quality improvement 
     program under section __111(a) of all grievances and appeals 
     relating to quality of care.

     SEC. __132. INTERNAL APPEALS OF ADVERSE DETERMINATIONS.

       (a) Right of Appeal.--
       (1) In general.--A participant or beneficiary in a group 
     health plan, and an enrollee in health insurance coverage 
     offered by a health insurance issuer, and any provider or 
     other person acting on behalf of such an individual with the 
     individual's consent, may appeal any appealable decision (as 
     defined in paragraph (2)) under the procedures described in 
     this section and (to the extent applicable) section __133. 
     Such individuals and providers shall be provided with a 
     written explanation of the appeal process and the 
     determination upon the conclusion of the appeals process and 
     as provided in section __121(b)(8).
       (2) Appealable decision defined.--In this section, the term 
     ``appealable decision'' means any of the following:
       (A) Denial, reduction, or termination of, or failure to 
     provide or make payment (in whole or in part) for a benefit, 
     including a failure to cover an item or service for which 
     benefits are otherwise provided because it is determined to 
     be experimental or investigational or not medically necessary 
     or appropriate.
       (B) Failure to provide coverage of emergency services or 
     reimbursement of maintenance care or post-stabilization care 
     under section __101.
       (C) Failure to provide a choice of provider under section 
     __103.
       (D) Failure to provide qualified health care providers 
     under section __103.
       (E) Failure to provide access to specialty and other care 
     under section __104.
       (F) Failure to provide continuation of care under section 
     __105.
       (G) Failure to provide coverage of routine patient costs in 
     connection with an approval clinical trial under section 
     __106.
       (H) Failure to provide access to needed drugs under section 
     __107(a)(3) or 107(b).
       (I) Discrimination in delivery of services in violation of 
     section __109.
       (J) An adverse determination under a utilization review 
     program under section __115.
       (K) The imposition of a limitation that is prohibited under 
     section __151.
       (b) Internal Appeal Process.--
       (1) In general.--Each group health plan and health 
     insurance issuer shall establish and maintain an internal 
     appeal process under which any participant, beneficiary, or 
     enrollee, or any provider or other person acting on behalf of 
     such an individual with the individual's consent, who is 
     dissatisfied with any appealable decision has the opportunity 
     to appeal the decision through an internal appeal process. 
     The appeal may be communicated orally.
       (2) Conduct of review.--
       (A) In general.--The process shall include a review of the 
     decision by a physician or other health care professional (or 
     professionals) who has been selected by the plan or issuer 
     and who has not been involved in the appealable decision at 
     issue in the appeal.
       (B) Availability and participation of clinical peers.--The 
     individuals conducting such review shall include one or more 
     clinical peers (as defined in section __191(c)(2)) who have 
     not been involved in the appealable decision at issue in the 
     appeal.
       (3) Deadline.--
       (A) In general.--Subject to subsection (c), the plan or 
     issuer shall conclude each appeal as soon as possible after 
     the time of the receipt of the appeal in accordance with 
     medical exigencies of the case involved, but in no event 
     later than--
       (i) 72 hours after the time of receipt of an expedited 
     appeal, and

[[Page S7345]]

       (ii) except as provided in subparagraph (B), 30 business 
     days after such time (or, if the participant, beneficiary, or 
     enrollee supplies additional information that was not 
     available to the plan or issuer at the time of the receipt of 
     the appeal, after the date of supplying such additional 
     information) in the case of all other appeals.
       (B) Extension.--In the case of an appeal that does not 
     relate to a decision regarding an expedited appeal and that 
     does not involve medical exigencies, if a group health plan 
     or health insurance issuer is unable to conclude the appeal 
     within the time period provided under subparagraph (A)(ii) 
     due to circumstances beyond the control of the plan or 
     issuer, the deadline shall be extended for up to an 
     additional 10 business days if the plan or issuer provides, 
     on or before 10 days before the deadline otherwise 
     applicable, written notice to the participant, beneficiary, 
     or enrollee and the provider involved of the extension and 
     the reasons for the extension.
       (4) Notice.--If a plan or issuer denies an appeal, the plan 
     or issuer shall provide the participant, beneficiary, or 
     enrollee and provider involved with notice in printed form of 
     the denial and the reasons therefore, together with a notice 
     in printed form of rights to any further appeal.
       (c) Expedited Review Process.--
       (1) In general.--A group health plan, and a health 
     insurance issuer, shall establish procedures in writing for 
     the expedited consideration of appeals under subsection (b) 
     in situations in which the application of the normal 
     timeframe for making a determination could seriously 
     jeopardize the life or health of the participant, 
     beneficiary, or enrollee (including in the case of a child, 
     development) or such an individual's ability to regain 
     maximum function.
       (2) Process.--Under such procedures--
       (A) the request for expedited appeal may be submitted 
     orally or in writing by an individual or provider who is 
     otherwise entitled to request the appeal; and
       (B) all necessary information, including the plan's or 
     issuer's decision, shall be transmitted between the plan or 
     issuer and the requester by telephone, facsimile, or other 
     similarly expeditious available method.
       (d) Direct Use of Further Appeals.--In the event that the 
     plan or issuer fails to comply with any of the deadlines for 
     completion of appeals under this section or in the event that 
     the plan or issuer for any reason expressly waives its rights 
     to an internal review of an appeal under subsection (b), the 
     participant, beneficiary, or enrollee involved and the 
     provider involved shall be relieved of any obligation to 
     complete the appeal involved and may, at such an individual's 
     or provider's option, proceed directly to seek further appeal 
     through any applicable external appeals process.

     SEC. __133. EXTERNAL APPEALS OF ADVERSE DETERMINATIONS.

       (a) Right to External Appeal.--
       (1) In general.--A group health plan, and a health 
     insurance issuer offering group health insurance coverage, 
     shall provide for an external appeals process that meets the 
     requirements of this section in the case of an externally 
     appealable decision described in paragraph (2). The 
     appropriate Secretary shall establish standards to carry out 
     such requirements.
       (2) Externally appealable decision defined.--For purposes 
     of this section, the term ``externally appealable decision'' 
     means an appealable decision (as defined in section 
     __132(a)(2)) if--
       (A) the amount involved exceeds a significant threshold; or
       (B) the patient's life or health is jeopardized (including, 
     in the case of a child, development) as a consequence of the 
     decision.
     Such term does not include a denial of coverage for services 
     that are specifically listed in plan or coverage documents as 
     excluded from coverage.
       (3) Exhaustion of internal appeals process.--A plan or 
     issuer may condition the use of an external appeal process in 
     the case of an externally appealable decision upon completion 
     of the internal review process provided under section __132, 
     but only if the decision is made in a timely basis consistent 
     with the deadlines provided under this chapter.
       (b) General Elements of External Appeals Process.--
       (1) Contract with qualified external appeal entity.--
       (A) Contract requirement.--Subject to subparagraph (B), the 
     external appeal process under this section of a plan or 
     issuer shall be conducted under a contract between the plan 
     or issuer and one or more qualified external appeal entities 
     (as defined in subsection (c)).
       (B) Restrictions on qualified external appeal entity.--
       (i) By state for health insurance issuers.--With respect to 
     health insurance issuers in a State, the State may provide 
     for external review activities to be conducted by a qualified 
     external appeal entity that is designated by the State or 
     that is selected by the State in such a manner as to assure 
     an unbiased determination.
       (ii) By federal government for group health plans.--With 
     respect to group health plans, the appropriate Secretary may 
     exercise the same authority as a State may exercise with 
     respect to health insurance issuers under clause (i). Such 
     authority may include requiring the use of the qualified 
     external appeal entity designated or selected under such 
     clause.
       (iii) Limitation on plan or issuer selection.--If an 
     applicable authority permits more than one entity to qualify 
     as a qualified external appeal entity with respect to a group 
     health plan or health insurance issuer and the plan or issuer 
     may select among such qualified entities, the applicable 
     authority--

       (I) shall assure that the selection process will not create 
     any incentives for external appeal entities to make a 
     decision in a biased manner, and
       (II) shall implement procedures for auditing a sample of 
     decisions by such entities to assure that no such decisions 
     are made in a biased manner.

       (C) Other terms and conditions.--The terms and conditions 
     of a contract under this paragraph shall be consistent with 
     the standards the appropriate Secretary shall establish to 
     assure there is no real or apparent conflict of interest in 
     the conduct of external appeal activities. Such contract 
     shall provide that the direct costs of the process (not 
     including costs of representation of a participant, 
     beneficiary, or enrollee) shall be paid by the plan or 
     issuer, and not by the participant, beneficiary, or enrollee.
       (2) Elements of process.--An external appeal process shall 
     be conducted consistent with standards established by the 
     appropriate Secretary that include at least the following:
       (A) Fair process; de novo determination.--The process shall 
     provide for a fair, de novo determination.
       (B) Determination concerning externally appealable 
     decisions.--A qualified external appeal entity shall 
     determine whether a decision is an externally appealable 
     decision and related decisions, including--
       (i) whether such a decision involves an expedited appeal;
       (ii) the appropriate deadlines for internal review process 
     required due to medical exigencies in a case; and
       (iii) whether such a process has been completed.
       (C) Opportunity to submit evidence, have representation, 
     and make oral presentation.--Each party to an externally 
     appealable decision--
       (i) may submit and review evidence related to the issues in 
     dispute,
       (ii) may use the assistance or representation of one or 
     more individuals (any of whom may be an attorney), and
       (iii) may make an oral presentation.
       (D) Provision of information.--The plan or issuer involved 
     shall provide timely access to all its records relating to 
     the matter of the externally appealable decision and to all 
     provisions of the plan or health insurance coverage 
     (including any coverage manual) relating to the matter.
       (E) Timely decisions.--A determination by the external 
     appeal entity on the decision shall--
       (i) be made orally or in writing and, if it is made orally, 
     shall be supplied to the parties in writing as soon as 
     possible;
       (ii) be binding on the plan or issuer;
       (iii) be made in accordance with the medical exigencies of 
     the case involved, but in no event later than 60 days (or 72 
     hours in the case of an expedited appeal) from the date of 
     completion of the filing of notice of external appeal of the 
     decision;
       (iv) state, in layperson's language, the basis for the 
     determination, including, if relevant, any basis in the terms 
     or conditions of the plan or coverage; and
       (v) inform the participant, beneficiary, or enrollee of the 
     individual's rights to seek further review by the courts (or 
     other process) of the external appeal determination.
       (c) Qualifications of External Appeal Entities.--
       (1) In general.--For purposes of this section, the term 
     ``qualified external appeal entity'' means, in relation to a 
     plan or issuer, an entity (which may be a governmental 
     entity) that is certified under paragraph (2) as meeting the 
     following requirements:
       (A) There is no real or apparent conflict of interest that 
     would impede the entity conducting external appeal activities 
     independent of the plan or issuer.
       (B) The entity conducts external appeal activities through 
     clinical peers.
       (C) The entity has sufficient medical, legal, and other 
     expertise and sufficient staffing to conduct external appeal 
     activities for the plan or issuer on a timely basis 
     consistent with subsection (b)(3)(E).
       (D) The entity meets such other requirements as the 
     appropriate Secretary may impose.
       (2) Certification of external appeal entities.--
       (A) In general.--In order to be treated as a qualified 
     external appeal entity with respect to--
       (i) a group health plan, the entity must be certified (and, 
     in accordance with subparagraph (B), periodically 
     recertified) as meeting the requirements of paragraph (1) by 
     the Secretary of Labor (or under a process recognized or 
     approved by the Secretary of Labor); or
       (ii) a health insurance issuer operating in a State, the 
     entity must be certified (and, in accordance with 
     subparagraph (B), periodically recertified) as meeting such 
     requirements by the applicable State authority (or, if the 
     State has not established an adequate certification and 
     recertification process, by the Secretary of Health and Human 
     Services,

[[Page S7346]]

     or under a process recognized or approved by such Secretary).
       (B) Recertification process.--The appropriate Secretary 
     shall develop standards for the recertification of external 
     appeal entities. Such standards shall include a specification 
     of--
       (i) the information required to be submitted as a condition 
     of recertification on the entity's performance of external 
     appeal activities, which information shall include the number 
     of cases reviewed, a summary of the disposition of those 
     cases, the length of time in making determinations on those 
     cases, and such information as may be necessary to assure the 
     independence of the entity from the plans or issuers for 
     which external appeal activities are being conducted; and
       (ii) the periodicity which recertification will be 
     required.
       (d) Continuing Legal Rights of Enrollees.--Nothing in this 
     subtitle shall be construed as removing any legal rights of 
     participants, beneficiaries, enrollees, and others under 
     State or Federal law, including the right to file judicial 
     actions to enforce rights.

         CHAPTER 5--PROTECTING THE DOCTOR-PATIENT RELATIONSHIP

     SEC. __141. PROHIBITION OF INTERFERENCE WITH CERTAIN MEDICAL 
                   COMMUNICATIONS.

       (a) Prohibition.--
       (1) General rule.--The provisions of any contract or 
     agreement, or the operation of any contract or agreement, 
     between a group health plan or health insurance issuer in 
     relation to health insurance coverage (including any 
     partnership, association, or other organization that enters 
     into or administers such a contract or agreement) and a 
     health care provider (or group of health care providers) 
     shall not prohibit or restrict the provider from engaging in 
     medical communications with the provider's patient.
       (2) Nullification.--Any contract provision or agreement 
     that restricts or prohibits medical communications in 
     violation of paragraph (1) shall be null and void.
       (b) Rules of Construction.--Nothing in this section shall 
     be construed--
       (1) to prohibit the enforcement, as part of a contract or 
     agreement to which a health care provider is a party, of any 
     mutually agreed upon terms and conditions, including terms 
     and conditions requiring a health care provider to 
     participate in, and cooperate with, all programs, policies, 
     and procedures developed or operated by a group health plan 
     or health insurance issuer to assure, review, or improve the 
     quality and effective utilization of health care services (if 
     such utilization is according to guidelines or protocols that 
     are based on clinical or scientific evidence and the 
     professional judgment of the provider) but only if the 
     guidelines or protocols under such utilization do not 
     prohibit or restrict medical communications between providers 
     and their patients; or
       (2) to permit a health care provider to misrepresent the 
     scope of benefits covered under the group health plan or 
     health insurance coverage or to otherwise require a group 
     health plan health insurance issuer to reimburse providers 
     for benefits not covered under the plan or coverage.
       (c) Medical Communication Defined.--In this section:
       (1) In general.--The term ``medical communication'' means 
     any communication made by a health care provider with a 
     patient of the health care provider (or the guardian or legal 
     representative of such patient) with respect to--
       (A) the patient's health status, medical care, or treatment 
     options;
       (B) any utilization review requirements that may affect 
     treatment options for the patient; or
       (C) any financial incentives that may affect the treatment 
     of the patient.
       (2) Misrepresentation.--The term ``medical communication'' 
     does not include a communication by a health care provider 
     with a patient of the health care provider (or the guardian 
     or legal representative of such patient) if the communication 
     involves a knowing or willful misrepresentation by such 
     provider.

     SEC. __142. PROHIBITION AGAINST TRANSFER OF INDEMNIFICATION 
                   OR IMPROPER INCENTIVE ARRANGEMENTS.

       (a) Prohibition of Transfer of Indemnification.--
       (1) In general.--No contract or agreement between a group 
     health plan or health insurance issuer (or any agent acting 
     on behalf of such a plan or issuer) and a health care 
     provider shall contain any provision purporting to transfer 
     to the health care provider by indemnification or otherwise 
     any liability relating to activities, actions, or omissions 
     of the plan, issuer, or agent (as opposed to the provider).
       (2) Nullification.--Any contract or agreement provision 
     described in paragraph (1) shall be null and void.
       (b) Prohibition of Improper Physician Incentive Plans.--
       (1) In general.--A group health plan and a health insurance 
     issuer offering health insurance coverage may not operate any 
     physician incentive plan (as defined in subparagraph (B) of 
     section 1876(i)(8) of the Social Security Act) unless the 
     requirements described in subparagraph (A) of such section 
     are met with respect to such a plan.
       (2) Application.--For purposes of carrying out paragraph 
     (1), any reference in section 1876(i)(8) of the Social 
     Security Act to the Secretary, an eligible organization, or 
     an individual enrolled with the organization shall be treated 
     as a reference to the applicable authority, a group health 
     plan or health insurance issuer, respectively, and a 
     participant, beneficiary, or enrollee with the plan or 
     organization, respectively.

     SEC. __143. ADDITIONAL RULES REGARDING PARTICIPATION OF 
                   HEALTH CARE PROFESSIONALS.

       (a) Procedures.--Insofar as a group health plan, or health 
     insurance issuer that offers health insurance coverage, 
     provides benefits through participating health care 
     professionals, the plan or issuer shall establish reasonable 
     procedures relating to the participation (under an agreement 
     between a professional and the plan or issuer) of such 
     professionals under the plan or coverage. Such procedures 
     shall include--
       (1) providing notice of the rules regarding participation;
       (2) providing written notice of participation decisions 
     that are adverse to professionals; and
       (3) providing a process within the plan or issuer for 
     appealing such adverse decisions, including the presentation 
     of information and views of the professional regarding such 
     decision.
       (b) Consultation in Medical Policies.--A group health plan, 
     and health insurance issuer that offers health insurance 
     coverage, shall consult with participating physicians (if 
     any) regarding the plan's or issuer's medical policy, 
     quality, and medical management procedures.

     SEC. __144. PROTECTION FOR PATIENT ADVOCACY.

       (a) Protection for Use of Utilization Review and Grievance 
     Process.--A group health plan, and a health insurance issuer 
     with respect to the provision of health insurance coverage, 
     may not retaliate against a participant, beneficiary, 
     enrollee, or health care provider based on the participant's, 
     beneficiary's, enrollee's or provider's use of, or 
     participation in, a utilization review process or a grievance 
     process of the plan or issuer (including an internal or 
     external review or appeal process) under this subtitle.
       (b) Protection for Quality Advocacy by Health Care 
     Professionals.--
       (1) In general.--A group health plan or health insurance 
     issuer may not retaliate or discriminate against a protected 
     health care professional because the professional in good 
     faith--
       (A) discloses information relating to the care, services, 
     or conditions affecting one or more participants, 
     beneficiaries, or enrollees of the plan or issuer to an 
     appropriate public regulatory agency, an appropriate private 
     accreditation body, or appropriate management personnel of 
     the plan or issuer; or
       (B) initiates, cooperates, or otherwise participates in an 
     investigation or proceeding by such an agency with respect to 
     such care, services, or conditions.

     If an institutional health care provider is a participating 
     provider with such a plan or issuer or otherwise receives 
     payments for benefits provided by such a plan or issuer, the 
     provisions of the previous sentence shall apply to the 
     provider in relation to care, services, or conditions 
     affecting one or more patients within an institutional health 
     care provider in the same manner as they apply to the plan or 
     issuer in relation to care, services, or conditions provided 
     to one or more participants, beneficiaries, or enrollees; and 
     for purposes of applying this sentence, any reference to a 
     plan or issuer is deemed a reference to the institutional 
     health care provider.
       (2) Good faith action.--For purposes of paragraph (1), a 
     protected health care professional is considered to be acting 
     in good faith with respect to disclosure of information or 
     participation if, with respect to the information disclosed 
     as part of the action--
       (A) the disclosure is made on the basis of personal 
     knowledge and is consistent with that degree of learning and 
     skill ordinarily possessed by health care professionals with 
     the same licensure or certification and the same experience;
       (B) the professional reasonably believes the information to 
     be true;
       (C) the information evidences either a violation of a law, 
     rule, or regulation, of an applicable accreditation standard, 
     or of a generally recognized professional or clinical 
     standard or that a patient is in imminent hazard of loss of 
     life or serious injury; and
       (D) subject to subparagraphs (B) and (C) of paragraph (3), 
     the professional has followed reasonable internal procedures 
     of the plan, issuer, or institutional health care provider 
     established for the purpose of addressing quality concerns 
     before making the disclosure.
       (3) Exception and special rule.--
       (A) General exception.--Paragraph (1) does not protect 
     disclosures that would violate Federal or State law or 
     diminish or impair the rights of any person to the continued 
     protection of confidentiality of communications provided by 
     such law.
       (B) Notice of internal procedures.--Subparagraph (D) of 
     paragraph (2) shall not apply unless the internal procedures 
     involved are reasonably expected to be known to the health 
     care professional involved. For purposes of this 
     subparagraph, a health care professional is reasonably 
     expected to know of internal procedures if those procedures 
     have been made available to the professional through 
     distribution or posting.

[[Page S7347]]

       (C) Internal procedure exception.--Subparagraph (D) of 
     paragraph (2) also shall not apply if--
       (i) the disclosure relates to an imminent hazard of loss of 
     life or serious injury to a patient;
       (ii) the disclosure is made to an appropriate private 
     accreditation body pursuant to disclosure procedures 
     established by the body; or
       (iii) the disclosure is in response to an inquiry made in 
     an investigation or proceeding of an appropriate public 
     regulatory agency and the information disclosed is limited to 
     the scope of the investigation or proceeding.
       (4) Additional considerations.--It shall not be a violation 
     of paragraph (1) to take an adverse action against a 
     protected health care professional if the plan, issuer, or 
     provider taking the adverse action involved demonstrates that 
     it would have taken the same adverse action even in the 
     absence of the activities protected under such paragraph.
       (5) Notice.--A group health plan, health insurance issuer, 
     and institutional health care provider shall post a notice, 
     to be provided or approved by the Secretary of Labor, setting 
     forth excerpts from, or summaries of, the pertinent 
     provisions of this subsection and information pertaining to 
     enforcement of such provisions.
       (6) Constructions.--
       (A) Determinations of coverage.--Nothing in this subsection 
     shall be construed to prohibit a plan or issuer from making a 
     determination not to pay for a particular medical treatment 
     or service or the services of a type of health care 
     professional.
       (B) Enforcement of peer review protocols and internal 
     procedures.--Nothing in this subsection shall be construed to 
     prohibit a plan, issuer, or provider from establishing and 
     enforcing reasonable peer review or utilization review 
     protocols or determining whether a protected health care 
     professional has complied with those protocols or from 
     establishing and enforcing internal procedures for the 
     purpose of addressing quality concerns.
       (C) Relation to other rights.--Nothing in this subsection 
     shall be construed to abridge rights of participants, 
     beneficiaries, enrollees, and protected health care 
     professionals under other applicable Federal or State laws.
       (7) Protected health care professional defined.--For 
     purposes of this subsection, the term ``protected health care 
     professional'' means an individual who is a licensed or 
     certified health care professional and who--
       (A) with respect to a group health plan or health insurance 
     issuer, is an employee of the plan or issuer or has a 
     contract with the plan or issuer for provision of services 
     for which benefits are available under the plan or issuer; or
       (B) with respect to an institutional health care provider, 
     is an employee of the provider or has a contract or other 
     arrangement with the provider respecting the provision of 
     health care services.

               CHAPTER 6--PROMOTING GOOD MEDICAL PRACTICE

     SEC. __151. PROMOTING GOOD MEDICAL PRACTICE.

       (a) Prohibiting Arbitrary Limitations or Conditions for the 
     Provision of Services.--
       (1) In general.--A group health plan, and a health 
     insurance issuer in connection with the provision of health 
     insurance coverage, may not arbitrarily interfere with or 
     alter the decision of the treating physician regarding the 
     manner or setting in which particular services are delivered 
     if the services are medically necessary or appropriate for 
     treatment or diagnosis to the extent that such treatment or 
     diagnosis is otherwise a covered benefit.
       (2) Construction.--Paragraph (1) shall not be construed as 
     prohibiting a plan or issuer from limiting the delivery of 
     services to one or more health care providers within a 
     network of such providers.
       (3) Manner or setting defined.--In paragraph (1), the term 
     ``manner or setting'' means the location of treatment, such 
     as whether treatment is provided on an inpatient or 
     outpatient basis, and the duration of treatment, such as the 
     number of days in a hospital. Such term does not include the 
     coverage of a particular service or treatment.
       (b) No Change in Coverage.--Subsection (a) shall not be 
     construed as requiring coverage of particular services the 
     coverage of which is otherwise not covered under the terms of 
     the plan or coverage or from conducting utilization review 
     activities consistent with this subsection.
       (c) Medical Necessity or Appropriateness Defined.--In 
     subsection (a), the term ``medically necessary or 
     appropriate'' means, with respect to a service or benefit, a 
     service or benefit which is consistent with generally 
     accepted principles of professional medical practice.

     SEC. __152. STANDARDS RELATING TO BENEFITS FOR CERTAIN BREAST 
                   CANCER TREATMENT.

       (a) Inpatient Care.--
       (1) In general.--A group health plan, and a health 
     insurance issuer offering group health insurance coverage, 
     that provides medical and surgical benefits shall ensure that 
     inpatient coverage with respect to the treatment of breast 
     cancer is provided for a period of time as is determined by 
     the attending physician, in his or her professional judgment 
     consistent with generally accepted medical standards, in 
     consultation with the patient, to be medically appropriate 
     following--
       (A) a mastectomy;
       (B) a lumpectomy; or
       (C) a lymph node dissection for the treatment of breast 
     cancer.
       (2) Exception.--Nothing in this section shall be construed 
     as requiring the provision of inpatient coverage if the 
     attending physician and patient determine that a shorter 
     period of hospital stay is medically appropriate.
       (b) Prohibitions.--A group health plan, and a health 
     insurance issuer offering group health insurance coverage in 
     connection with a group health plan, may not--
       (1) deny to a woman eligibility, or continued eligibility, 
     to enroll or to renew coverage under the terms of the plan, 
     solely for the purpose of avoiding the requirements of this 
     section;
       (2) provide monetary payments or rebates to women to 
     encourage such women to accept less than the minimum 
     protections available under this section;
       (3) penalize or otherwise reduce or limit the reimbursement 
     of an attending provider because such provider provided care 
     to an individual participant or beneficiary in accordance 
     with this section;
       (4) provide incentives (monetary or otherwise) to an 
     attending provider to induce such provider to provide care to 
     an individual participant or beneficiary in a manner 
     inconsistent with this section; or
       (5) subject to subsection (c)(3), restrict benefits for any 
     portion of a period within a hospital length of stay required 
     under subsection (a) in a manner which is less favorable than 
     the benefits provided for any preceding portion of such stay.
       (c) Rules of Construction.--
       (1) Nothing in this section shall be construed to require a 
     woman who is a participant or beneficiary--
       (A) to undergo a mastectomy or lymph node dissection in a 
     hospital; or
       (B) to stay in the hospital for a fixed period of time 
     following a mastectomy or lymph node dissection.
       (2) This section shall not apply with respect to any group 
     health plan, or any group health insurance coverage offered 
     by a health insurance issuer, which does not provide benefits 
     for hospital lengths of stay in connection with a mastectomy 
     or lymph node dissection for the treatment of breast cancer.
       (3) Nothing in this section shall be construed as 
     preventing a group health plan or issuer from imposing 
     deductibles, coinsurance, or other cost-sharing in relation 
     to benefits for hospital lengths of stay in connection with a 
     mastectomy or lymph node dissection for the treatment of 
     breast cancer under the plan (or under health insurance 
     coverage offered in connection with a group health plan), 
     except that such coinsurance or other cost-sharing for any 
     portion of a period within a hospital length of stay required 
     under subsection (a) may not be greater than such coinsurance 
     or cost-sharing for any preceding portion of such stay.
       (d) Level and Type of Reimbursements.--Nothing in this 
     section shall be construed to prevent a group health plan or 
     a health insurance issuer offering group health insurance 
     coverage from negotiating the level and type of reimbursement 
     with a provider for care provided in accordance with this 
     section.
       (e) Exception for Health Insurance Coverage in Certain 
     States.--
       (1) In general.--The requirements of this section shall not 
     apply with respect to health insurance coverage if there is a 
     State law (as defined in section 2723(d)(1) of the Public 
     Health Service Act) for a State that regulates such coverage 
     that is described in any of the following subparagraphs:
       (A) Such State law requires such coverage to provide for at 
     least a 48-hour hospital length of stay following a 
     mastectomy performed for treatment of breast cancer and at 
     least a 24-hour hospital length of stay following a lymph 
     node dissection for treatment of breast cancer.
       (B) Such State law requires, in connection with such 
     coverage for surgical treatment of breast cancer, that the 
     hospital length of stay for such care is left to the decision 
     of (or required to be made by) the attending provider in 
     consultation with the woman involved.
       (2) Construction.--Section 2723(a)(1) of the Public Health 
     Service Act and section 731(a)(1) of the Employee Retirement 
     Income Security Act of 1974 shall not be construed as 
     superseding a State law described in paragraph (1).

                         CHAPTER 7--DEFINITIONS

     SEC. __191. DEFINITIONS.

       (a) Incorporation of General Definitions.--The provisions 
     of section 2971 of the Public Health Service Act shall apply 
     for purposes of this subtitle in the same manner as they 
     apply for purposes of title XXVII of such Act.
       (b) Secretary.--Except as otherwise provided, the term 
     ``Secretary'' means the Secretary of Health and Human 
     Services, in consultation with the Secretary of Labor and the 
     Secretary of the Treasury and the term ``appropriate 
     Secretary'' means the Secretary of Health and Human Services 
     in relation to carrying out this subtitle under sections 2707 
     and 2753 of the Public Health Service Act, the Secretary of 
     Labor in relation to carrying out this subtitle under section 
     714 of the Employee Retirement Income Security Act of 1974, 
     and the Secretary of the Treasury in relation to carrying out 
     this

[[Page S7348]]

     subtitle under chapter 100 and section 4980D of the Internal 
     Revenue Code of 1986.
       (c) Additional Definitions.--For purposes of this subtitle:
       (1) Applicable authority.--The term ``applicable 
     authority'' means--
       (A) in the case of a group health plan, the Secretary of 
     Health and Human Services and the Secretary of Labor; and
       (B) in the case of a health insurance issuer with respect 
     to a specific provision of this subtitle, the applicable 
     State authority (as defined in section 2791(d) of the Public 
     Health Service Act), or the Secretary of Health and Human 
     Services, if such Secretary is enforcing such provision under 
     section 2722(a)(2) or 2761(a)(2) of the Public Health Service 
     Act.
       (2) Clinical peer.--The term ``clinical peer'' means, with 
     respect to a review or appeal, a physician (allopathic or 
     osteopathic) or other health care professional who holds a 
     non-restricted license in a State and who is appropriately 
     credentialed in the same or similar specialty as typically 
     manages the medical condition, procedure, or treatment under 
     review or appeal and includes a pediatric specialist where 
     appropriate; except that only a physician may be a clinical 
     peer with respect to the review or appeal of treatment 
     rendered by a physician.
       (3) Health care provider.--The term ``health care 
     provider'' includes a physician or other health care 
     professional, as well as an institutional provider of health 
     care services.
       (4) Nonparticipating.--The term ``nonparticipating'' means, 
     with respect to a health care provider that provides health 
     care items and services to a participant, beneficiary, or 
     enrollee under group health plan or health insurance 
     coverage, a health care provider that is not a participating 
     health care provider with respect to such items and services.
       (5) Participating.--The term ``participating'' means, with 
     respect to a health care provider that provides health care 
     items and services to a participant, beneficiary, or enrollee 
     under group health plan or health insurance coverage offered 
     by a health insurance issuer, a health care provider that 
     furnishes such items and services under a contract or other 
     arrangement with the plan or issuer.

     SEC. __192. PREEMPTION; STATE FLEXIBILITY; CONSTRUCTION.

       (a) Continued Applicability of State Law With Respect to 
     Health Insurance Issuers.--
       (1) In general.--Subject to paragraph (2), this subtitle 
     shall not be construed to supersede any provision of State 
     law which establishes, implements, or continues in effect any 
     standard or requirement solely relating to health insurance 
     issuers in connection with group health insurance coverage 
     except to the extent that such standard or requirement 
     prevents the application of a requirement of this subtitle.
       (2) Continued preemption with respect to group health 
     plans.--Nothing in this subtitle shall be construed to affect 
     or modify the provisions of section 514 of the Employee 
     Retirement Income Security Act of 1974 with respect to group 
     health plans.
       (b) Rules of Construction.--Except as provided in section 
     __152, nothing in this subtitle shall be construed as 
     requiring a group health plan or health insurance coverage to 
     provide specific benefits under the terms of such plan or 
     coverage.
       (c) Definitions.--For purposes of this section:
       (1) State law.--The term ``State law'' includes all laws, 
     decisions, rules, regulations, or other State action having 
     the effect of law, of any State. A law of the United States 
     applicable only to the District of Columbia shall be treated 
     as a State law rather than a law of the United States.
       (2) State.--The term ``State'' includes a State, the 
     Northern Mariana Islands, any political subdivisions of a 
     State or such Islands, or any agency or instrumentality of 
     either.

     SEC. __193. REGULATIONS.

       The Secretaries of Health and Human Services, Labor, and 
     the Treasury shall issue such regulations as may be necessary 
     or appropriate to carry out this subtitle. Such regulations 
     shall be issued consistent with section 104 of Health 
     Insurance Portability and Accountability Act of 1996. Such 
     Secretaries may promulgate any interim final rules as the 
     Secretaries determine are appropriate to carry out this 
     subtitle.

Subtitle B--Application of Patient Protection Standards to Group Health 
  Plans and Health Insurance Coverage Under Public Health Service Act

     SEC. __201. APPLICATION TO GROUP HEALTH PLANS AND GROUP 
                   HEALTH INSURANCE COVERAGE.

       (a) In General.--Subpart 2 of part A of title XXVII of the 
     Public Health Service Act, as amended by the Omnibus 
     Consolidated and Emergency Supplemental Appropriations Act, 
     1999 (Public Law 105-277), is amended by adding at the end 
     the following new section:

     ``SEC. 2707. PATIENT PROTECTION STANDARDS.

       ``(a) In General.--Each group health plan shall comply with 
     patient protection requirements under subtitle A of the 
     Patients' Bill of Rights Act of 1999, and each health 
     insurance issuer shall comply with patient protection 
     requirements under such subtitle with respect to group health 
     insurance coverage it offers, and such requirements shall be 
     deemed to be incorporated into this subsection.
       ``(b) Notice.--A group health plan shall comply with the 
     notice requirement under section 711(d) 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.''.
       (b) 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 2707)'' after 
     ``requirements of such subparts''.

     SEC. __202. APPLICATION TO INDIVIDUAL HEALTH INSURANCE 
                   COVERAGE.

       Subpart 3 of part B 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. 2753. PATIENT PROTECTION STANDARDS.

       ``(a) In General.--Each health insurance issuer shall 
     comply with patient protection requirements under subtitle A 
     of the Patients' Bill of Rights Act of 1999 with respect to 
     individual health insurance coverage it offers, and such 
     requirements shall be deemed to be incorporated into this 
     subsection.
       ``(b) Notice.--A health insurance issuer under this part 
     shall comply with the notice requirement under section 711(d) 
     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.''.

 Subtitle C--Amendments to the Employee Retirement Income Security Act 
                                of 1974

     SEC. __301. APPLICATION OF PATIENT PROTECTION STANDARDS TO 
                   GROUP HEALTH PLANS AND GROUP HEALTH INSURANCE 
                   COVERAGE UNDER THE EMPLOYEE RETIREMENT INCOME 
                   SECURITY ACT OF 1974.

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

     ``SEC. 714. PATIENT PROTECTION STANDARDS.

       ``(a) In General.--Subject to subsection (b), a group 
     health plan (and a health insurance issuer offering group 
     health insurance coverage in connection with such a plan) 
     shall comply with the requirements of subtitle A of the 
     Patients' Bill of Rights Act of 1999 (as in effect as of the 
     date of the enactment of such Act), and such requirements 
     shall be deemed to be incorporated into this subsection.
       ``(b) 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 subtitle A of the Patients' Bill of Rights Act of 1999 
     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 __101 (relating to access to emergency care).
       ``(B) Section __102(a)(1) (relating to offering option to 
     purchase point-of-service coverage), but only insofar as the 
     plan is meeting such requirement through an agreement with 
     the issuer to offer the option to purchase point-of-service 
     coverage under such section.
       ``(C) Section __103 (relating to choice of providers).
       ``(D) Section __104 (relating to access to specialty care).
       ``(E) Section __105(a)(1) (relating to continuity in case 
     of termination of provider contract) and section __105(a)(2) 
     (relating to continuity in case of termination of issuer 
     contract), but only insofar as a replacement issuer assumes 
     the obligation for continuity of care.
       ``(F) Section __106 (relating to coverage for individuals 
     participating in approved clinical trials.)
       ``(G) Section __107 (relating to access to needed 
     prescription drugs).
       ``(H) Section __108 (relating to adequacy of provider 
     network).
       ``(I) Chapter 2 of subtitle A (relating to quality 
     assurance).
       ``(J) Section __143 (relating to additional rules regarding 
     participation of health care professionals).
       ``(K) Section __152 (relating to standards relating to 
     benefits for certain breast cancer treatment).
       ``(2) Information.--With respect to information required to 
     be provided or made available under section __121, 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

[[Page S7349]]

     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 sections 131 and 132, 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 __133, 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 any of the following 
     sections, the group health plan shall not be liable for such 
     violation unless the plan caused such violation:
       ``(A) Section __109 (relating to nondiscrimination in 
     delivery of services).
       ``(B) Section __141 (relating to prohibition of 
     interference with certain medical communications).
       ``(C) Section __142 (relating to prohibition against 
     transfer of indemnification or improper incentive 
     arrangements).
       ``(D) Section __144 (relating to prohibition on 
     retaliation).
       ``(E) Section __151 (relating to promoting good medical 
     practice).
       ``(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.
       ``(7) Application to certain prohibitions against 
     retaliation.--With respect to compliance with the 
     requirements of section __144(b)(1) of the Patients' Bill of 
     Rights Act of 1999, for purposes of this subtitle the term 
     `group health plan' is deemed to include a reference to an 
     institutional health care provider.
       ``(c) Enforcement of Certain Requirements.--
       ``(1) Complaints.--Any protected health care professional 
     who believes that the professional has been retaliated or 
     discriminated against in violation of section __144(b)(1) of 
     the Patients' Bill of Rights Act of 1999 may file with the 
     Secretary a complaint within 180 days of the date of the 
     alleged retaliation or discrimination.
       ``(2) Investigation.--The Secretary shall investigate such 
     complaints and shall determine if a violation of such section 
     has occurred and, if so, shall issue an order to ensure that 
     the protected health care professional does not suffer any 
     loss of position, pay, or benefits in relation to the plan, 
     issuer, or provider involved, as a result of the violation 
     found by the Secretary.
       ``(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) Satisfaction of ERISA Claims Procedure Requirement.--
     Section 503 of the Employee Retirement Income Security Act of 
     1974 (29 U.S.C. 1133) is amended by inserting ``(a)'' after 
     ``Sec. 503.'' and by adding at the end the following new 
     subsection:
       ``(b) In the case of a group health plan (as defined in 
     section 733) compliance with the requirements of chapter 4 
     (and section __115) of subtitle A of the Patients' Bill of 
     Rights Act of 1999 in the case of a claims denial shall be 
     deemed compliance with subsection (a) with respect to such 
     claims denial.''.
       (c) Conforming Amendments.--
       (1) Section 732(a) of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1185(a)) is amended by 
     striking ``section 711'' and inserting ``sections 711 and 
     714''.
       (2) The table of contents in section 1 of the Employee 
     Retirement Income Security Act of 1974, as amended by the 
     Omnibus Consolidated and Emergency Supplemental 
     Appropriations Act, 1999 (Public Law 105-277), is amended by 
     inserting after the item relating to section 713 the 
     following new item:

``Sec. 714. Patient protection standards.''.

       (3) Section 502(b)(3) of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1132(b)(3)) is amended by 
     inserting ``(other than section 144(b))'' after ``part 7''.

     SEC. __302. ERISA PREEMPTION NOT TO APPLY TO CERTAIN ACTIONS 
                   INVOLVING HEALTH INSURANCE POLICYHOLDERS.

       (a) In General.--Section 514 of the Employee Retirement 
     Income Security Act of 1974 (29 U.S.C. 1144) is amended by 
     adding at the end the following subsection:
       ``(e) Preemption Not To Apply to Certain Actions Arising 
     Out of Provision of Health Benefits.--
       ``(1) In general.--Except as provided in this subsection, 
     nothing in this title shall be construed to invalidate, 
     impair, or supersede any cause of action brought by a plan 
     participant or beneficiary (or the estate of a plan 
     participant or beneficiary) under State law to recover 
     damages resulting from personal injury or for wrongful death 
     against any person--
       ``(A) in connection with the provision of insurance, 
     administrative services, or medical services by such person 
     to or for a group health plan (as defined in section 733), or
       ``(B) that arises out of the arrangement by such person for 
     the provision of such insurance, administrative services, or 
     medical services by other persons.
       ``(2) Exception for employers and other plan sponsors.--
       ``(A) In general.--Subject to subparagraph (B), paragraph 
     (1) does not authorize--
       ``(i) any cause of action against an employer or other plan 
     sponsor maintaining the group health plan or against an 
     employee of such an employer or sponsor acting within the 
     scope of employment, or
       ``(ii) a right of recovery or indemnity by a person against 
     an employer or other plan sponsor (or such an employee) for 
     damages assessed against the person pursuant to a cause of 
     action under paragraph (1).
       ``(B) Special rule.--Subparagraph (A) shall not preclude 
     any cause of action described in paragraph (1) against an 
     employer or other plan sponsor (or against an employee of 
     such an employer or sponsor acting within the scope of 
     employment) if--
       ``(i) such action is based on the employer's or other plan 
     sponsor's (or employee's) exercise of discretionary authority 
     to make a decision on a claim for benefits covered under the 
     plan or health insurance coverage in the case at issue; and
       ``(ii) the exercise by such employer or other plan sponsor 
     (or employee of such authority) resulted in personal injury 
     or wrongful death.
       ``(3) Construction.--Nothing in this subsection shall be 
     construed as permitting a cause of action under State law for 
     the failure to provide an item or service which is not 
     covered under the group health plan involved.
       ``(4) Personal injury defined.--For purposes of this 
     subsection, the term `personal injury' means a physical 
     injury and includes an injury arising out of the treatment 
     (or failure to treat) a mental illness or disease.''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall apply to acts and omissions occurring on or after the 
     date of the enactment of this Act from which a cause of 
     action arises.

     SEC. __303. LIMITATION IN ACTIONS.

       Section 502 of Employee Retirement Income Security Act of 
     1974 (29 U.S.C. 1132) is amended by adding at the end the 
     following:
       ``(n)(1) Except as provided in this section, no action may 
     be brought under subsection (a)(1)(B), (a)(2), or (a)(3) by a 
     participant or beneficiary seeking relief based on the 
     application of any provision in chapter 1 (other than section 
     __109) of subtitle A, chapter 5 of subtitle A, or section 
     __115 or __151 of the Patient's Bill of Rights Act of 1999 
     (as incorporated under section 714).
       ``(2) An action may be brought under subsection (a)(1)(B), 
     (a)(2), or (a)(3) by a participant or beneficiary seeking 
     relief based on the application of section __101, __104, 
     __105, __106, __107(a)(3), __107(b), __115, or __151 of the 
     Patient's Bill of Rights Act of 1999 (as incorporated under 
     section 714) 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 and for any relief 
     to any other person.
       ``(3) Nothing in this subsection shall be construed as 
     affecting any action brought by the Secretary.''.

   Subtitle D--Application to Group Health Plans Under the Internal 
                          Revenue Code of 1986

     SEC. __401. AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986.

       Subchapter B of chapter 100 of the Internal Revenue Code of 
     1986 (as amended by section 1531(a) of the Taxpayer Relief 
     Act of 1997) 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 patient freedom of choice.''; 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 requirements of 
     subtitle A of the Patients' Bill of Rights Act of 1999 (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.''.

      Subtitle E--Effective Dates; Coordination in Implementation

     SEC. __501. EFFECTIVE DATES AND RELATED RULES.

       (a) Group Health Coverage.--
       (1) In general.--Subject to paragraph (2), the amendments 
     made by sections 201(a), 301, and 401 (and subtitle A insofar 
     as it relates to such sections) shall apply with respect to 
     group health plans, and health insurance

[[Page S7350]]

     coverage offered in connection with group health plans, for 
     plan years beginning on or after October 1, 2000 (in this 
     section referred to as the ``general effective date'').
       (2) Treatment of collective bargaining agreements.--In the 
     case of a group health plan maintained pursuant to 1 or more 
     collective bargaining agreements between employee 
     representatives and 1 or more employers ratified before the 
     date of enactment of this title, the amendments made by 
     sections __201(a), __301, and __401 (and subtitle A insofar 
     as it relates to such sections) shall not apply to plan years 
     beginning before the later of--
       (A) the date on which the last collective bargaining 
     agreements relating to the plan terminates (determined 
     without regard to any extension thereof agreed to after the 
     date of enactment of this Act), or
       (B) the general effective date.

     For purposes of subparagraph (A), any plan amendment made 
     pursuant to a collective bargaining agreement relating to the 
     plan which amends the plan solely to conform to any 
     requirement added by this title shall not be treated as a 
     termination of such collective bargaining agreement.
       (b) Individual Health Insurance Coverage.--The amendments 
     made by section __202 shall apply with respect to individual 
     health insurance coverage offered, sold, issued, renewed, in 
     effect, or operated in the individual market on or after the 
     general effective date.
       (c) Treatment of Religious Nonmedical Providers.--
       (1) In general.--Nothing in this title (or the amendments 
     made thereby) shall be construed to--
       (A) restrict or limit the right of group health plans, and 
     of health insurance issuers offering health insurance 
     coverage, to include as providers religious nonmedical 
     providers;
       (B) require such plans or issuers to--
       (i) utilize medically based eligibility standards or 
     criteria in deciding provider status of religious nonmedical 
     providers;
       (ii) use medical professionals or criteria to decide 
     patient access to religious nonmedical providers;
       (iii) utilize medical professionals or criteria in making 
     decisions in internal or external appeals regarding coverage 
     for care by religious nonmedical providers; or
       (iv) compel a participant or beneficiary to undergo a 
     medical examination or test as a condition of receiving 
     health insurance coverage for treatment by a religious 
     nonmedical provider; or
       (C) require such plans or issuers to exclude religious 
     nonmedical providers because they do not provide medical or 
     other required data, if such data is inconsistent with the 
     religious nonmedical treatment or nursing care provided by 
     the provider.
       (2) Religious nonmedical provider.--For purposes of this 
     subsection, the term ``religious nonmedical provider'' means 
     a provider who provides no medical care but who provides only 
     religious nonmedical treatment or religious nonmedical 
     nursing care.

     SEC. __502. COORDINATION IN IMPLEMENTATION.

       Section 104(1) of Health Insurance Portability and 
     Accountability Act of 1996 is amended by striking ``this 
     subtitle (and the amendments made by this subtitle and 
     section 401)'' and inserting ``the provisions of part 7 of 
     subtitle B of title I of the Employee Retirement Income 
     Security Act of 1974, the provisions of parts A and C of 
     title XXVII of the Public Health Service Act, chapter 100 of 
     the Internal Revenue Code of 1986, and subtitle A of the 
     Patients' Bill of Rights Act of 1999''.

     SEC. __503. NO IMPACT ON SOCIAL SECURITY TRUST FUND.

       (a) In General.--Nothing in this title shall be construed 
     to alter or amend the Social Security Act (or any regulation 
     promulgated under that Act).
       (b) Transfers.--
       (1) Estimate of secretary.--The Secretary of the Treasury 
     shall annually estimate the impact that the enactment of this 
     title has on the income and balances of the trust funds 
     established under section 201 of the Social Security Act (42 
     U.S.C. 401).
       (2) Transfer of funds.--If, under paragraph (1), the 
     Secretary of the Treasury estimates that the enactment of 
     this title 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 title.

                 Subtitle F--Revenue-Related Provisions

     SEC. __601. INFORMATION REQUIREMENTS.

       (a) 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).''
       (b) Effective Date.--The amendment made by subsection (a) 
     shall take effect 180 days after the date of the enactment of 
     this Act.

     SEC. __602. EXTENSION OF HAZARDOUS SUBSTANCE SUPERFUND TAXES.

       (a) Extension of Taxes.--
       (1) Environmental tax.--Section 59A(e) of the Internal 
     Revenue Code of 1986 is amended to read as follows:
       ``(e) Application of Tax.--The tax imposed by this section 
     shall apply to taxable years beginning after December 31, 
     1986, and before January 1, 1996, and to taxable years 
     beginning after December 31, 1998, and before January 1, 
     2010.''
       (2) Excise taxes.--Section 4611(e) of such Code is amended 
     to read as follows:
       ``(e) Application of Hazardous Substance Superfund 
     Financing Rate.--The Hazardous Substance Superfund financing 
     rate under this section shall apply after December 31, 1986, 
     and before January 1, 1996, and after September 15, 1999, and 
     before October 1, 2009.''
       (b) Effective Dates.--
       (1) Income tax.--The amendment made by subsection (a)(1) 
     shall apply to taxable years beginning after December 31, 
     1998.
       (2) Excise tax.--The amendment made by subsection (a)(2) 
     shall take effect on September 15, 1999.

     SEC. __603. MODIFICATION TO FOREIGN TAX CREDIT CARRYBACK AND 
                   CARRYOVER PERIODS.

       (a) In General.--Section 904(c) of the Internal Revenue 
     Code of 1986 (relating to limitation on credit) is amended--
       (1) by striking ``in the second preceding taxable year,'', 
     and
       (2) by striking ``or fifth'' and inserting ``fifth, sixth, 
     or seventh''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall apply to credits arising in taxable years beginning 
     after December 31, 2001.

     SEC. __604. LIMITATIONS ON WELFARE BENEFIT FUNDS OF 10 OR 
                   MORE EMPLOYER PLANS.

       (a) Benefits to Which Exception Applies.--Section 
     419A(f)(6)(A) of the Internal

[[Page S7351]]

     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.''
       (b) Limitation on Use of Amounts for Other Purposes.--
     Section 4976(b) of the Internal Revenue Code of 1986 
     (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.''
       (c) Effective Date.--The amendments made by this section 
     shall apply to contributions paid or accrued after the date 
     of the enactment of this Act, in taxable years ending after 
     such date.

     SEC. __605. MODIFICATION OF INSTALLMENT METHOD AND REPEAL OF 
                   INSTALLMENT METHOD FOR ACCRUAL METHOD 
                   TAXPAYERS.

       (a) Repeal of Installment Method for Accrual Basis 
     Taxpayers.--
       (1) 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).''
       (2) Conforming amendments.--Sections 453(d)(1), 453(i)(1), 
     and 453(k) of the Internal Revenue Code of 1986 are each 
     amended by striking ``(a)'' each place it appears and 
     inserting ``(a)(1)''.
       (b) Modification of Pledge Rules.--Paragraph (4) of section 
     453A(d) (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.''
       (c) Effective Date.--The amendments made by this section 
     shall apply to sales or other dispositions occurring on or 
     after the date of the enactment of this Act.
                                 ______
                                 

                         LOTT AMENDMENT NO. 703

  Mr. LOTT proposed an amendment to amendment No. 702 proposed by Mr. 
Daschle to the bill, S. 1233, supra; as follows:

       Beginning on page 1 of the amendment, line 2, strike all 
     after the first word and insert the following:

             __--ACCESS TO QUALITY, AFFORDABLE HEALTH CARE

     SEC. __01. SHORT TITLE.

       This title may be cited as the ``Patients' Bill of Rights 
     Plus Act''.

                  Subtitle A--Patients' Bill of Rights

                  CHAPTER 1--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

[[Page S7352]]

     plan year, an employer who employed an average of at least 2 
     but not more than 50 employees on business days during the 
     preceding calendar year and who employs at least 2 employees 
     on the first day of the plan year. For purposes of this 
     paragraph, the provisions of subparagraph (C) of section 
     712(c)(1) shall apply in determining employer size.
       ``(d) Rule of Construction.--Nothing in this section shall 
     be construed--
       ``(1) as requiring coverage for benefits for a particular 
     type of health care professional;
       ``(2) as requiring an employer to pay any costs as a result 
     of this section or to make equal contributions with respect 
     to different health coverage options;
       ``(3) as preventing a group health plan (other than a fully 
     insured group health plan) from imposing higher premiums or 
     cost-sharing on a participant for the exercise of a point-of-
     service coverage option; or
       ``(4) to require that a group health plan (other than a 
     fully insured group health plan) include coverage of health 
     care professionals that the plan excludes because of fraud, 
     quality of care, or other similar reasons with respect to 
     such professionals.

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

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

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

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

     ``SEC. 725. ACCESS TO SPECIALISTS.

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

     ``SEC. 726. CONTINUITY OF CARE.

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

     the transitional period under this subsection with respect to 
     provider's treatment of the pregnancy shall extend through 
     the provision of post-partum care directly related to the 
     delivery.
       ``(4) Terminal illness.--Subject to paragraph (1), if--
       ``(A) a participant or beneficiary was determined to be 
     terminally ill (as determined under section 1861(dd)(3)(A) of 
     the Social Security Act) prior to a provider's termination of 
     participation; and
       ``(B) the provider was treating the terminal illness before 
     the date of termination;
     the transitional period under this subsection shall be for 
     care directly related to the treatment of the terminal 
     illness.
       ``(c) Permissible Terms and Conditions.--A group health 
     plan (other than a fully insured group health plan) may 
     condition coverage of continued treatment by a provider under 
     subsection (a)(1)(C) upon the provider agreeing to the 
     following terms and conditions:
       ``(1) The provider agrees to accept reimbursement from the 
     plan and individual involved (with respect to cost-sharing) 
     at the rates applicable prior to the start of the 
     transitional period as payment in full (or at the rates 
     applicable under the replacement plan after the date of the 
     termination of the contract with the group health plan) and 
     not to impose cost-sharing with respect to the individual in 
     an amount that would exceed

[[Page S7353]]

     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) Rule With Respect to Certain Plans.--
       (1) In general.--Notwithstanding any other provision of 
     law, health insurance issuers may offer, and eligible 
     individuals may purchase, high deductible health plans 
     described in section 220(c)(2)(A) of the Internal Revenue 
     Code of 1986. Effective for the 4-year period beginning on 
     the date of the enactment of this Act, such health plans 
     shall not be required to provide payment for any health care 
     items or services that are exempt from the plan's deductible.
       (2) Existing state laws.--A State law relating to payment 
     for health care items and services in effect on the date of 
     enactment of this Act that is preempted under paragraph (1), 
     shall not apply to high deductible health plans after the 
     expiration of the 4-year period described in such paragraph 
     unless the State reenacts such law after such period.
       (c) 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.''.
       (d) 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 chapter 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 chapter, against a group health plan with respect to a 
     violation of a requirement imposed by such amendments before 
     the date of issuance of t 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

[[Page S7354]]

     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 chapter 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 chapter, against a group health plan with respect to a 
     violation of a requirement imposed by such amendments before 
     the date of issuance of ``(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).''
       (b) Effective Date.--The amendment made by subsection (a) 
     shall take effect 180 days after the date of the enactment of 
     this Act.

     SEC. __602. EXTENSION OF HAZARDOUS SUBSTANCE SUPERFUND TAXES.

       (a) Extension of Taxes.--
       (1) Environmental tax.--Section 59A(e) of the Internal 
     Revenue Code of 1986 is amended to read as follows:
       ``(e) Application of Tax.--The tax imposed by this section 
     shall apply to taxable years beginning after December 31, 
     1986, and before January 1, 1996, and to taxable years 
     beginning after December 31, 1998, and before January 1, 
     2010.''
       (2) Excise taxes.--Section 4611(e) of such Code is amended 
     to read as follows:
       ``(e) Application of Hazardous Substance Superfund 
     Financing Rate.--The Insurance Ombudsman through a contract 
     with a not-for-profit organization that operates independent 
     of group health plans and health insurance issuers and that 
     is responsible for carrying out with respect to that State 
     the functions otherwise provided under subsection (a) by a 
     Health Insurance Ombudsman.
       (c) Authorization of Appropriations.--There are authorized 
     to be appropriated to the Secretary of Health and Human 
     Services such amounts as may be necessary to provide for 
     grants to States for contracts for Health Insurance Ombudsmen 
     under subsection (a) or contracts for such Ombudsmen under 
     subsection (b).
       (d) Construction.--Nothing in this section shall be 
     construed to prevent the use of other forms of enrollee 
     assistance.

              CHAPTER 4--GRIEVANCE AND APPEALS PROCEDURES

     SEC. __131. ESTABLISHMENT OF GRIEVANCE PROCESS.

       (a) Establishment of Grievance System.--
       (1) In general.--A group health plan, and a health 
     insurance issuer in connection with the provision of health 
     insurance coverage, shall establish and maintain a system to 
     provide for the presentation and resolution of oral and 
     written grievances brought by individuals who are 
     participants, beneficiaries, or enrollees, or health care 
     providers or other individuals acting on behalf of an 
     individual and with the individual's consent, regarding any 
     aspect of the plan's or issuer's services.
       (2) Scope.--The system shall include grievances regarding 
     access to and availability of services, quality of care, 
     choice and accessibility of providers, network adequacy, and 
     compliance with the requirements of this subtitle.
       (b) Grievance System.--Such system shall include the 
     following components with respect to individuals who are 
     participants, beneficiaries, or enrollees:
       (1) Written notification to all such individuals and 
     providers of the telephone numbers and business addresses of 
     the plan or issuer personnel responsible for resolution of 
     grievances and appeals.
       (2) A system to record and document, over a period of at 
     least 3 previous years, all grievances and appeals made and 
     their status.
       (3) A process providing for timely processing and 
     resolution of grievances.
       (4) Procedures for follow-up action, including the methods 
     to inform the person making the grievance of the resolution 
     of the grievance.
       (5) Notification to the continuous quality improvement 
     program under section __111(a) of all grievances and appeals 
     relating to quality of care.

     SEC. __132. INTERNAL APPEALS OF ADVERSE DETERMINATIONS.

       (a) Right of Appeal.--
       (1) In general.--A participant or beneficiary in a group 
     health plan, and an enrollee in health insurance coverage 
     offered by a health insurance issuer, and any provider or 
     other person acting on behalf of such an individual 
     regulations issued in connection with such requirement, if 
     the plan has sought to comply in good faith with such 
     requirement.

       CHAPTER 2--RIGHT TO INFORMATION ABOUT PLANS AND PROVIDERS

     SEC. __111. INFORMATION ABOUT PLANS.

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

     ``SEC. 714. HEALTH PLAN COMPARATIVE INFORMATION.

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

[[Page S7355]]

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

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

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

     ``SEC. 9813. HEALTH PLAN COMPARATIVE INFORMATION.

       ``(a) Requirement.--
       ``(1) In general.--A group health plan shall, not later 
     than 12 months after the date of enactment of this section, 
     and at least annually thereafter, provide for the disclosure, 
     in a clear and accurate form to each participant and each 
     beneficiary who does not reside at the same address as the 
     participant, or upon request to an individual eligible for 
     coverage under the plan, of the information described in 
     subsection (b).
       ``(2) Rules of construction.--Nothing in this section shall 
     be construed to prevent a plan from entering into any 
     agreement under which a health insurance issuer agrees to 
     assume responsibility for compliance with the requirements of 
     this section and the plan is released from liability for such 
     compliance.
       ``(3) Provision of information.--Information shall be 
     provided to participants and beneficiaries under this section 
     at the address maintained by the plan with respect to such 
     participants or beneficiaries.
       ``(b) Required Information.--The informational materials to 
     be distributed under this section shall include for each 
     package option available under a group health plan the 
     following:
       ``(1) A description of the covered items and services under 
     each such plan and any in- and out-of-network features of 
     each such plan, including a summary description of the 
     specific exclusions from coverage under the plan.
       ``(2) A description of any cost-sharing, including 
     premiums, deductibles, coinsurance, and copayment amounts, 
     for which the participant or beneficiary will be responsible, 
     including any annual or lifetime limits on benefits, for each 
     such plan.
       ``(3) A description of any optional supplemental benefits 
     offered by each such plan and the terms and conditions 
     (including premiums or cost-sharing) for such supplemental 
     coverage.
       ``(4) A description of any restrictions on payments for 
     services furnished to a participant or beneficiary by a 
     health care professional that is not a participating 
     professional and the liability of the participant or 
     beneficiary for additional payments for these services.
       ``(5) A description of the service area of each such plan, 
     including the provision of any out-of-area coverage.
       ``(6) A description of the extent to which participants and 
     beneficiaries may select the primary care provider of their 
     choice, including providers both within the network and 
     outside the network of each such plan (if the plan permits 
     out-of-network services).
       ``(7) A description of the procedures for advance 
     directives and organ donation decisions if the plan maintains 
     such procedures.
       ``(8) A description of the requirements and procedures to 
     be used to obtain preauthorization for health services 
     (including telephone numbers and mailing addresses), 
     including referrals for specialty care.
       ``(9) A description of the definition of medical necessity 
     used in making coverage determinations by each such plan.
       ``(10) A summary of the rules and methods for appealing 
     coverage decisions and filing grievances (including telephone 
     numbers and mailing addresses), as well as other available 
     remedies.
       ``(11) A summary description of any provisions for 
     obtaining off-formulary medications if the plan utilizes a 
     defined formulary for providing specific prescription 
     medications.
       ``(12) A summary of the rules for access to emergency room 
     care. Also, any available educational material regarding 
     proper use of emergency services.

[[Page S7356]]

       ``(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).

           CHAPTER 3--RIGHT TO HOLD HEALTH PLANS ACCOUNTABLE

     SEC. __121. AMENDMENT TO EMPLOYEE RETIREMENT INCOME SECURITY 
                   ACT OF 1974.

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

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

       ``(a) Claims Procedure.--In accordance with regulations of 
     the Secretary, every employee benefit plan shall--
       ``(1) provide adequate notice in writing to any participant 
     or beneficiary whose claim for benefits under the plan has 
     been denied, setting forth the specific reasons for such 
     denial, written in a manner calculated to be understood by 
     the participant; and
       ``(2) afford a reasonable opportunity to any participant 
     whose claim for benefits has been denied for a full and fair 
     review by the appropriate named fiduciary of the decision 
     denying the claim.
       ``(b) Coverage Determinations Under Group Health Plans.--
       ``(1) Procedures.--
       ``(A) In general.--A group health plan or health insurance 
     issuer conducting utilization review shall ensure that 
     procedures are in place for--
       ``(i) making determinations regarding whether a participant 
     or beneficiary is eligible to receive a payment or coverage 
     for health services under the plan or coverage involved and 
     any cost-sharing amount that the participant or beneficiary 
     is required to pay with respect to such service;
       ``(ii) notifying a covered participant or beneficiary (or 
     the authorized representative of such participant or 
     beneficiary) and the treating health care professionals 
     involved regarding determinations made under the plan or 
     issuer and any additional payments that the participant or 
     beneficiary may be required to make with respect to such 
     service; and
       ``(iii) responding to requests, either written or oral, for 
     coverage determinations or for internal appeals from a 
     participant or beneficiary (or the authorized representative 
     of such participant or beneficiary) or the treating health 
     care professional with the consent of the participant or 
     beneficiary.
       ``(B) Oral requests.--With respect to an oral request 
     described in subparagraph (A)(iii), a group health plan or 
     health insurance issuer may require that the requesting 
     individual provide written evidence of such request.
       ``(2) Timeline for making determinations.--
       ``(A) Routine determination.--A group health plan or a 
     health insurance issuer shall maintain procedures to ensure 
     that prior authorization determinations concerning the 
     provision of non-emergency items or services are made within 
     30 days from the date on which the request for a 
     determination is submitted, except that such period may be 
     extended where certain circumstances exist that are 
     determined by the Secretary to be beyond control of the plan 
     or issuer.
       ``(B) Expedited determination.--
       ``(i) In general.--A prior authorization determination 
     under this subsection shall be made within 72 hours, in 
     accordance with the medical exigencies of the case, after a 
     request is received by the plan or issuer under clause (ii) 
     or (iii).
       ``(ii) Request by participant or beneficiary.--A plan or 
     issuer shall maintain procedures for expediting a prior 
     authorization determination under this subsection upon the 
     request of a participant or beneficiary if, based on such a 
     request, the plan or issuer determines that the normal time 
     for making such a determination could seriously jeopardize 
     the life or health of the participant or beneficiary.
       ``(iii) Documentation by health care professional.--A plan 
     or issuer shall maintain procedures for expediting a prior 
     authorization determination under this subsection if the 
     request involved indicates that the treating health care 
     professional has reasonably documented, based on the medical 
     exigencies, that a determination under the procedures 
     described in subparagraph (A) could seriously jeopardize the 
     life or health of the participant or beneficiary.
       ``(C) Concurrent determinations.--A plan or issuer shall 
     maintain procedures to certify or deny coverage of an 
     extended stay or additional services.
       ``(D) Retrospective determination.--A plan or issuer shall 
     maintain procedures to ensure that, with respect to the 
     retrospective review of a determination made under paragraph 
     (1), the determination shall be made within 30 working days 
     of the date on which the plan or issuer receives necessary 
     information.
       ``(3) Notice of determinations.--
       ``(A) Routine determination.--With respect to a coverage 
     determination of a plan or issuer under paragraph (2)(A), the 
     plan or issuer shall issue notice of such determination to 
     the participant or beneficiary (or the authorized 
     representative of the participant or beneficiary) and, 
     consistent with the medical exigencies of the case, to the 
     treating health care professional involved not later than 2 
     working days after the date on which the determination is 
     made.
       ``(B) Expedited determination.--With respect to a coverage 
     determination of a plan or issuer under paragraph (2)(B), the 
     plan or issuer shall issue notice of such determination to 
     the participant or beneficiary (or the authorized 
     representative of the participant or beneficiary), and 
     consistent with the medical exigencies of the case, to the 
     treating health care professional involved within the 72 hour 
     period described in paragraph (2)(B).
       ``(C) Concurrent reviews.--With respect to the 
     determination under a plan or issuer

[[Page S7357]]

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

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

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

[[Page S7358]]

     the participant or beneficiary (or the authorized 
     representative of the participant or beneficiary) and the 
     plan administrator, indicating that an independent external 
     review has been initiated.
       ``(3) Conduct of independent external review.--
       ``(A) Designation of external appeals entity by plan or 
     issuer.--
       ``(i) In general.--A plan or issuer that receives a request 
     for an independent external review under paragraph (2)(A) 
     shall designate a qualified entity described in clause (ii), 
     in a manner designed to ensure that the entity so designated 
     will make a decision in an unbiased manner, to serve as the 
     external appeals entity.
       ``(ii) Qualified entities.--A qualified entity shall be--

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

       ``(B) Designation of independent external reviewer by 
     external appeals entity.--The external appeals entity 
     designated under subparagraph (A) shall, not later than 30 
     days after the date on which such entity is designated under 
     subparagraph (A), or earlier in accordance with the medical 
     exigencies of the case, designate one or more individuals to 
     serve as independent external reviewers with respect to a 
     request received under paragraph (2)(A). Such reviewers shall 
     be independent medical experts who shall--
       ``(i) be appropriately credentialed or licensed in any 
     State to deliver health care services;
       ``(ii) not have any material, professional, familial, or 
     financial affiliation with the case under review, the 
     participant or beneficiary involved, the treating health care 
     professional, the institution where the treatment would take 
     place, or the manufacturer of any drug, device, procedure, 
     or other therapy proposed for the participant or 
     beneficiary whose treatment is under review;
       ``(iii) have expertise (including age-appropriate 
     expertise) in the diagnosis or treatment under review and, 
     when reasonably available, be of the same specialty as the 
     physician treating the participant or beneficiary or 
     recommending or prescribing the treatment in question;
       ``(iv) receive only reasonable and customary compensation 
     from the group health plan or health insurance issuer in 
     connection with the independent external review that is not 
     contingent on the decision rendered by the reviewer; and
       ``(v) not be held liable for decisions regarding medical 
     determinations (but may be held liable for actions that are 
     arbitrary and capricious).
       ``(4) Standard of review.--
       ``(A) In general.--An independent external reviewer shall--
       ``(i) make an independent determination based on the valid, 
     relevant, scientific and clinical evidence to determine the 
     medical necessity, appropriateness, experimental or 
     investigational nature of the proposed treatment; and
       ``(ii) take into consideration appropriate and available 
     information, including any evidence-based decision making or 
     clinical practice guidelines used by the group health plan or 
     health insurance issuer; timely evidence or information 
     submitted by the plan, issuer, patient or patient's 
     physician; the patient's medical record; expert consensus; 
     and medical literature as defined in section 556(5) of the 
     Federal Food, Drug, and Cosmetic Act.
       ``(B) Notice.--The plan or issuer involved shall ensure 
     that the participant or beneficiary receives notice, within 
     30 days after the determination of the independent medical 
     expert, regarding the actions of the plan or issuer with 
     respect to the determination of such expert under the 
     independent external review.
       ``(5) Timeframe for review.--
       ``(A) In general.--The independent external reviewer shall 
     complete a review of an adverse coverage determination in 
     accordance with the medical exigencies of the case.
       ``(B) Limitation.--Notwithstanding subparagraph (A), a 
     review described in such subparagraph shall be completed not 
     later than 30 working days after the later of--
       ``(i) the date on which such reviewer is designated; or
       ``(ii) the date on which all information necessary to 
     completing such review is received.
       ``(6) Binding determination.--The determination of an 
     independent external reviewer under this subsection shall be 
     binding upon the plan or issuer if the provisions of this 
     subsection or the procedures implemented under such 
     provisions were complied with by the independent external 
     reviewer.
       ``(7) Study.--Not later than 2 years after the date of 
     enactment of this section, the General Accounting Office 
     shall conduct a study of a statistically appropriate sample 
     of completed independent external reviews. Such study shall 
     include an assessment of the process involved during an 
     independent external review and the basis of decisionmaking 
     by the independent external reviewer. The results of such 
     study shall be submitted to the appropriate committees of 
     Congress.
       ``(8) Effect on certain provisions.--Nothing in this 
     section shall be construed as affecting or modifying section 
     514 of this Act with respect to a group health plan.
       ``(f) Rule of Construction.--Nothing in this section shall 
     be construed to prohibit a plan administrator or plan 
     fiduciary or health plan medical director from requesting an 
     independent external review by an independent external 
     reviewer without first completing the internal review 
     process.
       ``(g) Definitions.--In this section:
       ``(1) Adverse coverage determination.--The term `adverse 
     coverage determination' means a coverage determination under 
     the plan which results in a denial of coverage or 
     reimbursement.
       ``(2) Coverage determination.--The term `coverage 
     determination' means with respect to items and services for 
     which coverage may be provided under a health plan, a 
     determination of whether or not such items and services are 
     covered or reimbursable under the coverage and terms of the 
     contract.
       ``(3) Grievance.--The term `grievance' means any complaint 
     made by a participant or beneficiary that does not involve a 
     coverage determination.
       ``(4) Group health plan.--The term `group health plan' 
     shall have the meaning given such term in section 733(a). In 
     applying this paragraph, excepted benefits described in 
     section 733(c) shall not be treated as benefits consisting of 
     medical care.
       ``(5) Health insurance coverage.--The term `health 
     insurance coverage' has the meaning given such term in 
     section 733(b)(1). In applying this paragraph, excepted 
     benefits described in section 733(c) shall not be treated as 
     benefits consisting of medical care.
       ``(6) Health insurance issuer.--The term `health insurance 
     issuer' has the meaning given such term in section 733(b)(2).
       ``(7) Prior authorization determination.--The term `prior 
     authorization determination' means a coverage determination 
     prior to the provision of the items and services as a 
     condition of coverage of the items and services under the 
     coverage.
       ``(8) Treating health care professional.--The term 
     `treating health care professional' with respect to a group 
     health plan, health insurance issuer or provider sponsored 
     organization means a physician (medical doctor or doctor of 
     osteopathy) or other health care practitioner who is acting 
     within the scope of his or her State licensure or 
     certification for the delivery of health care services and 
     who is primarily responsible for delivering those services to 
     the participant or beneficiary.
       ``(9) Utilization review.--The term `utilization review' 
     with respect to a group health plan or health insurance 
     coverage means a set of formal techniques designed to monitor 
     the use of, or evaluate the clinical necessity, 
     appropriateness, efficacy, or efficiency of, health care 
     services, procedures, or settings. Techniques may include 
     ambulatory review, prospective review, second opinion, 
     certification, concurrent review, case management, discharge 
     planning or retrospective review.''
       (b) Enforcement.--Section 502(c)(1) of the Employee 
     Retirement Income Security Act of 1974 (29 U.S.C. 1132(c)(1)) 
     is amended by inserting after ``or section 101(e)(1)'' the 
     following: ``, or fails to comply with a coverage 
     determination as required under section 503(e)(6),''.
       (c) Conforming Amendment.--The table of contents in section 
     1 of the Employee Retirement Income Security Act of 1974 is 
     amended by striking the item relating to section 503 and 
     inserting the following new item:

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

              Subtitle B--Genetic Information and Services

     SEC. __201. SHORT TITLE.

       This subtitle 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

[[Page S7359]]

     plan, shall not adjust premium or contribution amounts for a 
     group on the basis of predictive genetic information 
     concerning any individual (including a dependent) or family 
     member of the individual (including information about a 
     request for or receipt of genetic services).''.
       (3) Conforming amendments.--
       (A) In general.--Section 702(b) of the Employee Retirement 
     Income Security Act of 1974 (29 U.S.C. 1182(b)) is amended by 
     adding at the end the following:
       ``(3) Reference to related provision.--For a provision 
     prohibiting the adjustment of premium or contribution amounts 
     for a group under a group health plan on the basis of 
     predictive genetic information (including information about a 
     request for or receipt of genetic services), see section 
     715.''.
       (B) Table of contents.--The table of contents in section 1 
     of the Employee Retirement Income Security Act of 1974, as 
     amended by section __111(a), is further amended by inserting 
     after the item relating to section 714 the following new 
     item:

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

     SEC. __203. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.

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

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

       ``A group health plan, or a health insurance issuer 
     offering group health insurance coverage in connection with a 
     group health plan shall not adjust premium or contribution 
     amounts for a group on the basis of predictive genetic 
     information concerning any individual (including a dependent) 
     or family member of the individual (including information 
     about a request for or receipt of genetic services).''.
       (C) Conforming amendment.--Section 2702(b) of the Public 
     Health Service Act (42 U.S.C. 300gg-1(b)) is amended by 
     adding at the end the following:
       ``(3) Reference to related provision.--For a provision 
     prohibiting the adjustment of premium or contribution amounts 
     for a group under a group health plan on the basis of 
     predictive genetic information (including information about a 
     request for or receipt of genetic services), see section 
     2707.''.
       (D) Limitation on collection and disclosure of predictive 
     genetic information.--Section 2702 of the Public Health 
     Service Act (42 U.S.C. 300gg-1) is amended by adding at the 
     end the following:
       ``(c) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     group health plan, or a health insurance issuer offering 
     health insurance coverage in connection with a group health 
     plan, shall not request or require predictive genetic 
     information concerning any individual (including a dependent) 
     or a family member of the individual (including information 
     about a request for or receipt of genetic services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) In general.--Notwithstanding paragraph (1), a group 
     health plan, or a health insurance issuer offering health 
     insurance coverage in connection with a group health plan, 
     that provides health care items and services to an individual 
     or dependent may request (but may not require) that such 
     individual or dependent disclose, or authorize the collection 
     or disclosure of, predictive genetic information for purposes 
     of diagnosis, treatment, or payment relating to the provision 
     of health care items and services to such individual or 
     dependent.
       ``(B) Notice of confidentiality practices and description 
     of safeguards.--As a part

[[Page S7360]]

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

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

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

     SEC. __204. AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986.

       (a) Prohibition of Health Discrimination on the Basis of 
     Genetic Information or Genetic Services.--
       (1) No enrollment restriction for genetic services.--
     Section 9802(a)(1)(F) of the Internal Revenue Code of 1986 is 
     amended by inserting before the period the following: 
     ``(including information about a request for or receipt of 
     genetic services)''.
       (2) No discrimination in group premiums based on predictive 
     genetic information.--
       (A) In general.--Subchapter B of chapter 100 of the 
     Internal Revenue Code of 1986, as amended by section 
     __111(b), is further amended by adding at the end the 
     following:

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

       ``A group health plan shall not adjust premium or 
     contribution amounts for a group on the basis of predictive 
     genetic information concerning any individual (including a 
     dependent) or a family member of the individual (including 
     information about a request for or receipt of genetic 
     services).''.
       (B) Conforming amendment.--Section 9802(b) of the Internal 
     Revenue Code of 1986 is amended by adding at the end the 
     following:

[[Page S7361]]

       ``(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.

              Subtitle C--Healthcare Research and Quality

     SEC. __301. SHORT TITLE.

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

     SEC. __302. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

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

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

               ``PART A--ESTABLISHMENT AND GENERAL DUTIES

     ``SEC. 901. MISSION AND DUTIES.

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

     ``SEC. 902. GENERAL AUTHORITIES.

       ``(a) In General.--In carrying out section 901(b), the 
     Director shall support demonstration projects, conduct and 
     support research, evaluations, training, research networks, 
     multi-disciplinary centers, technical assistance, and the 
     dissemination of information, on healthcare, and on systems 
     for the delivery of such care, including activities with 
     respect to--
       ``(1) the quality, effectiveness, efficiency, 
     appropriateness and value of healthcare services;
       ``(2) quality measurement and improvement;
       ``(3) the outcomes, cost, cost-effectiveness, and use of 
     healthcare services and access to such services;

[[Page S7362]]

       ``(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 or systems for evidence rating widely 
     available. Agency publications containing healthcare 
     recommendations shall indicate the level of substantiating 
     evidence using such methods or systems.
       ``(b) Healthcare Improvement Research Centers and Provider-
     Based Research Networks.--In order to address the full 
     continuum of care and outcomes research, to link research to 
     practice improvement, and to speed the dissemination of 
     research findings to community practice settings, the Agency 
     shall employ research strategies and mechanisms that will 
     link research directly with clinical practice in 
     geographically diverse locations throughout the United 
     States, including--
       ``(1) Healthcare Improvement Research Centers that combine 
     demonstrated multidisciplinary expertise in outcomes or 
     quality improvement research with linkages to relevant sites 
     of care;
       ``(2) Provider-based Research Networks, including plan, 
     facility, or delivery system sites of care (especially 
     primary care), that can evaluate and promote quality 
     improvement; and
       ``(3) other innovative mechanisms or strategies to link 
     research with clinical practice.

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

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

[[Page S7363]]

       ``(2) Annual report.--Beginning in fiscal year 2003, the 
     Secretary, acting through the Director, shall submit to 
     Congress an annual report on national trends in the quality 
     of healthcare provided to the American people.

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

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

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

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

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

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

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

       ``(a) Requirement.--
       ``(1) In general.--To avoid duplication and ensure that 
     Federal resources are used efficiently and effectively, the 
     Secretary, acting through the Director, shall coordinate all 
     research, evaluations, and demonstrations related to health 
     services research, quality measurement and quality 
     improvement activities undertaken and supported by the 
     Federal Government.
       ``(2) Specific activities.--The Director, in collaboration 
     with the appropriate Federal officials representing all 
     concerned executive agencies and departments, shall develop 
     and manage a process to--
       ``(A) improve interagency coordination, priority setting, 
     and the use and sharing of research findings and data 
     pertaining to Federal quality improvement programs, 
     technology assessment, and health services research;
       ``(B) strengthen the research information infrastructure, 
     including databases, pertaining to Federal health services 
     research and healthcare quality improvement initiatives;
       ``(C) set specific goals for participating agencies and 
     departments to further health services research and 
     healthcare quality improvement; and
       ``(D) strengthen the management of Federal healthcare 
     quality improvement programs.
       ``(b) Study by the Institute of Medicine.--
       ``(1) In general.--To provide Congress, the Department of 
     Health and Human Services, and other relevant departments 
     with an independent, external review of their quality 
     oversight, quality improvement and quality research programs, 
     the Secretary shall enter into a contract with the Institute 
     of Medicine--
       ``(A) to describe and evaluate current quality improvement, 
     quality research and quality monitoring processes through--
       ``(i) an overview of pertinent health services research 
     activities and quality improvement efforts conducted by all 
     Federal programs, with particular attention paid to those 
     under titles XVIII, XIX, and XXI of the Social Security Act; 
     and
       ``(ii) a summary of the partnerships that the Department of 
     Health and Human Services has pursued with private 
     accreditation, quality measurement and improvement 
     organizations; and
       ``(B) to identify options and make recommendations to 
     improve the efficiency and effectiveness of quality 
     improvement programs through--
       ``(i) the improved coordination of activities across the 
     medicare, medicaid and child health insurance programs under 
     titles XVIII, XIX and XXI of the Social Security Act and 
     health services research programs;
       ``(ii) the strengthening of patient choice and 
     participation by incorporating state-of-the-art quality 
     monitoring tools and making information on quality available; 
     and
       ``(iii) the enhancement of the most effective programs, 
     consolidation as appropriate, and elimination of duplicative 
     activities within various federal agencies.
       ``(2) Requirements.--
       ``(A) In general.--The Secretary shall enter into a 
     contract with the Institute of Medicine for the preparation--

[[Page S7364]]

       ``(i) not later than 12 months after the date of enactment 
     of this title, of a report providing an overview of the 
     quality improvement programs of the Department of Health and 
     Human Services for the medicare, medicaid, and CHIP programs 
     under titles XVIII, XIX, and XXI of the Social Security Act; 
     and
       ``(ii) not later than 24 months after the date of enactment 
     of this title, of a final report containing recommendations.
       ``(B) Reports.--The Secretary shall submit the reports 
     described in subparagraph (A) to the Committee on Finance and 
     the Committee on Health, Education, Labor, and Pensions of 
     the Senate and the Committee on Ways and Means and the 
     Committee on Commerce of the House of Representatives.

                      ``PART C--GENERAL PROVISIONS

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

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

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

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

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

       ``(a) Standards With Respect to Utility of Data.--
       ``(1) In general.--To ensure the utility, accuracy, and 
     sufficiency of data collected by or for the Agency for the 
     purpose described in section 901(b), the Director shall 
     establish standard methods for developing and collecting such 
     data, taking into consideration--
       ``(A) other Federal health data collection standards; and
       ``(B) the differences between types of healthcare plans, 
     delivery systems, healthcare providers, and provider 
     arrangements.
       ``(2) Relationship with other department programs.--In any 
     case where standards

[[Page S7365]]

     under paragraph (1) may affect the administration of other 
     programs carried out by the Department of Health and Human 
     Services, including the programs under title XVIII, XIX or 
     XXI of the Social Security Act, or may affect health 
     information that is subject to a standard developed under 
     part C of title XI of the Social Security Act, they shall be 
     in the form of recommendations to the Secretary for such 
     program.
       ``(b) Statistics and Analyses.--The Director shall--
       ``(1) take appropriate action to ensure that statistics and 
     analyses developed under this title are of high quality, 
     timely, and duly comprehensive, and that the statistics are 
     specific, standardized, and adequately analyzed and indexed; 
     and
       ``(2) publish, make available, and disseminate such 
     statistics and analyses on as wide a basis as is practicable.
       ``(c) Authority Regarding Certain Requests.--Upon request 
     of a public or private entity, the Director may conduct or 
     support research or analyses otherwise authorized by this 
     title pursuant to arrangements under which such entity will 
     pay the cost of the services provided. Amounts received by 
     the Director under such arrangements shall be available to 
     the Director for obligation until expended.

     ``SEC. 924. DISSEMINATION OF INFORMATION.

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

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

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

     ``SEC. 926. CERTAIN ADMINISTRATIVE AUTHORITIES.

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

     ``SEC. 927. FUNDING.

       ``(a) Intent.--To ensure that the United States's 
     investment in biomedical research is rapidly translated into 
     improvements in the quality of patient care, there must be a

[[Page S7366]]

     corresponding investment in research on the most effective 
     clinical and organizational strategies for use of these 
     findings in daily practice. The authorization levels in 
     subsections (b) and (c) provide for a proportionate increase 
     in healthcare research as the United State's investment in 
     biomedical research increases.
       ``(b) Authorization of Appropriations.--For the purpose of 
     carrying out this title, there are authorized to be 
     appropriated $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''.

        Subtitle D--Enhanced Access to Health Insurance Coverage

     SEC. __401. FULL DEDUCTION OF HEALTH INSURANCE COSTS FOR 
                   SELF-EMPLOYED INDIVIDUALS.

       (a) In General.--Section 162(l)(1) of the Internal Revenue 
     Code of 1986 (relating to allowance of deductions) 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, 
     his spouse, and his dependents.''
       (b) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     1999.

     SEC. __402. FULL AVAILABILITY OF MEDICAL SAVINGS ACCOUNTS.

       (a) Availability Not Limited To Accounts for Employees of 
     Small Employers and Self-Employed Individuals.--
       (1) In general.--Section 220(c)(1)(A) of the Internal 
     Revenue Code of 1986 (relating to eligible individual) is 
     amended to read as follows:
       ``(A) In general.--The term `eligible individual' means, 
     with respect to any month, any individual if--
       ``(i) such individual is covered under a high deductible 
     health plan as of the 1st day of such month, and
       ``(ii) such individual is not, while covered under a high 
     deductible health plan, covered under any health plan--

       ``(I) which is not a high deductible health plan, and
       ``(II) which provides coverage for any benefit which is 
     covered under the high deductible health plan.''.

       (2) Conforming amendments.--
       (A) Section 220(c)(1) of such Code is amended by striking 
     subparagraphs (C) and (D).
       (B) Section 220(c) of such Code is amended by striking 
     paragraph (4) (defining small employer) and by redesignating 
     paragraph (5) as paragraph (4).
       (C) Section 220(b) of such Code is amended by striking 
     paragraph (4) (relating to deduction limited by compensation) 
     and by redesignating paragraphs (5), (6), and (7) as 
     paragraphs (4), (5), and (6), respectively.
       (b) Removal of Limitation on Number of Taxpayers Having 
     Medical Savings Accounts.--
       (1) In general.--Section 220 of the Internal Revenue Code 
     of 1986 (relating to medical savings accounts) is amended by 
     striking subsections (i) and (j).
       (2) Medicare+choice.--Section 138 of such Code (relating to 
     Medicare+Choice MSA) is amended by striking subsection (f).
       (c) Reduction in High Deductible Plan Minimum Annual 
     Deductible.--Section 220(c)(2)(A) of the Internal Revenue 
     Code of 1986 (relating to high deductible health plan) is 
     amended--
       (1) by striking ``$1,500'' in clause (i) and inserting 
     ``$1,000'', and
       (2) by striking ``$3,000'' in clause (ii) and inserting 
     ``$2,000''.
       (d) Increase in Contribution Limit to 100 Percent of Annual 
     Deductible.--
       (1) In general.--Section 220(b)(2) of the Internal Revenue 
     Code of 1986 (relating to monthly limitation) is amended to 
     read as follows:
       ``(2) Monthly limitation.--The monthly limitation for any 
     month is the amount equal to \1/12\ of the annual deductible 
     of the high deductible health plan of the individual.''
       (2) Conforming amendment.--Section 220(d)(1)(A) of such 
     Code is amended by striking ``75 percent of''.
       (e) Limitation on Additional Tax on Distributions Not Used 
     for Qualified Medical Expenses.--Section 220(f)(4) of the 
     Internal Revenue Code of 1986 (relating to additional tax on 
     distributions not used for qualified medical expenses) is 
     amended by adding at the end the following:
       ``(D) Exception in case of sufficient account balance.--
     Subparagraph (A) shall not apply to any payment or 
     distribution in any taxable year, but only to the extent such 
     payment or distribution does not reduce the fair market value 
     of the assets of the medical savings account to an amount 
     less than the annual deductible for the high deductible 
     health plan of the account holder (determined as of January 1 
     of the calendar year in which the taxable year begins).''.
       (f) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     1999.

     SEC. __403. CARRYOVER OF UNUSED BENEFITS FROM CAFETERIA 
                   PLANS, FLEXIBLE SPENDING ARRANGEMENTS, AND 
                   HEALTH FLEXIBLE SPENDING ACCOUNTS.

       (a) In General.--Section 125 of the Internal Revenue Code 
     of 1986 (relating to cafeteria plans) is amended by 
     redesignating subsections (h) and (i) as subsections (i) and 
     (j) and by inserting after subsection (g) the following new 
     subsection:
       ``(h) Allowance of Carryovers of Unused Benefits to Later 
     Taxable Years.--
       ``(1) In general.--For purposes of this title--
       ``(A) notwithstanding subsection (d)(2), a plan or other 
     arrangement shall not fail to be treated as a cafeteria plan 
     or flexible spending or similar arrangement, and
       ``(B) no amount shall be required to be included in gross 
     income by reason of this section or any other provision of 
     this chapter,

     solely because under such plan or other arrangement any 
     nontaxable benefit which is unused as of the close of a 
     taxable year may be carried forward to 1 or more succeeding 
     taxable years.
       ``(2) Limitation.--Paragraph (1) shall not apply to amounts 
     carried from a plan to the extent such amounts exceed $500 
     (applied on an annual basis). For purposes of this paragraph, 
     all plans and arrangements maintained by an employer or any 
     related person shall be treated as 1 plan.
       ``(3) Allowance of rollover.--
       ``(A) In general.--In the case of any unused benefit 
     described in paragraph (1) which consists of amounts in a 
     health flexible spending account or dependent care flexible 
     spending account, the plan or arrangement shall provide that 
     a participant may elect, in lieu of such carryover, to have 
     such amounts distributed to the participant.
       ``(B) Amounts not included in income.--Any distribution 
     under subparagraph (A) shall not be included in gross income 
     to the extent that such amount is transferred in a trustee-
     to-trustee transfer, or is contributed within 60 days of 
     the date of the distribution, to--
       ``(i) a qualified cash or deferred arrangement described in 
     section 401(k),
       ``(ii) a plan under which amounts are contributed by an 
     individual's employer for an annuity contract described in 
     section 403(b),
       ``(iii) an eligible deferred compensation plan described in 
     section 457, or
       ``(iv) a medical savings account (within the meaning of 
     section 220).

     Any amount rolled over under this subparagraph shall be 
     treated as a rollover contribution for the taxable year from 
     which the unused amount would otherwise be carried.
       ``(C) Treatment of rollover.--Any amount rolled over under 
     subparagraph (B) shall be treated as an eligible rollover 
     under section 220, 401(k), 403(b), or 457, whichever is 
     applicable, and shall be taken into account in applying any 
     limitation (or participation requirement) on employer or 
     employee contributions under such section or any other 
     provision of this chapter for the taxable year of the 
     rollover.
       ``(4) Cost-of-living adjustment.--In the case of any 
     taxable year beginning in a calendar year after 1999, the 
     $500 amount under paragraph (2) shall be adjusted at the same 
     time and in the same manner as under section 415(d)(2), 
     except that the base period taken into account shall be the 
     calendar quarter beginning October 1, 1998, and any increase 
     which is not a multiple of $50 shall be rounded to the next 
     lowest multiple of $50.''
       ``(5) Applicability.--This subsection shall apply to 
     taxable years beginning after December 31, 1999.''
       (b) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     1999.

     SEC. __404. PERMITTING CONTRIBUTION TOWARDS MEDICAL SAVINGS 
                   ACCOUNT THROUGH FEDERAL EMPLOYEES HEALTH 
                   BENEFITS PROGRAM (FEHBP).

       (a) Government Contribution to Medical Savings Account.--
       (1) In general.--Section 8906 of title 5, United States 
     Code, is amended by adding at the end the following:
       ``(j)(1) In the case of an employee or annuitant who is 
     enrolled in a catastrophic plan described by section 8903(5), 
     there shall be a Government contribution under this 
     subsection to a medical savings account established or 
     maintained for the benefit of the individual. The 
     contribution under this subsection shall be in addition to 
     the Government contribution under subsection (b).
       ``(2) The amount of the Government contribution under this 
     subsection with respect to an individual is equal to the 
     amount by which--

[[Page S7367]]

       ``(A) the maximum contribution allowed under subsection 
     (b)(1) with respect to any employee or annuitant, exceeds
       ``(B) the amount of the Government contribution actually 
     made with respect to the individual under subsection (b) for 
     coverage under the catastrophic plan.
       ``(3) The Government contributions under this subsection 
     shall be paid into a medical savings account (designated by 
     the individual involved) in a manner that is specified by the 
     Office and consistent with the timing of contributions under 
     subsection (b).
       ``(4) Subsections (f) and (g) shall apply to contributions 
     under this section in the same manner as they apply to 
     contributions under subsection (b).
       ``(5) For the purpose of this subsection, the term `medical 
     savings account' has the meaning given such term by section 
     220(d) of the Internal Revenue Code of 1986.''.
       (2) Allowing payment of full amount of charge for 
     catastrophic plan.--Section 8906(b)(2) of such title is 
     amended by inserting ``(or 100 percent of the subscription 
     charge in the case of a catastrophic plan)'' after ``75 
     percent of the subscription charge''.
       (b) Offering of Catastrophic Plans.--
       (1) In general.--Section 8903 of title 5, United States 
     Code, is amended by adding at the end the following:
       ``(5) Catastrophic plans.--One or more plans described in 
     paragraph (1), (2), or (3), but which provide benefits of the 
     types referred to by paragraph (5) of section 8904(a), 
     instead of the types referred to in paragraphs (1), (2), and 
     (3) of such section.''.
       (2) Types of benefits.--Section 8904(a) of such title is 
     amended by inserting after paragraph (4) the following new 
     paragraph:
       ``(5) Catastrophic plans.--Benefits of the types named 
     under paragraph (1) or (2) of this subsection or both, to the 
     extent expenses covered by the plan exceed $500.''.
       (3) Determining level of government contributions.--Section 
     8906(b) of such title is amended by adding at the end the 
     following: ``Subscription charges for medical savings 
     accounts shall be deemed to be the amount of Government 
     contributions made under subsection (j)(2).''.
       (c) Effective Date.--The amendments made by this section 
     shall apply to contract terms beginning on or after January 
     1, 2000.
                                 ______
                                 

                        BURNS AMENDMENT NO. 704

  (Ordered to lie on the table.)
  Mr. BURNS submitted an amendment intended to be proposed by him to 
the bill, S. 1233, supra; as follows:

       On page 76, between lines 6 and 7, insert the following:
       Sec. 7__. Sense of Senate on Lamb Meat Imports.--It is the 
     sense of the Senate that--
       (1) there is an overabundance of foreign lamb meat being 
     imported into the United States;
       (2) the glut of imported lamb meat is severely harming 
     domestic producers and the domestic agricultural industry;
       (3) the sheep industry filed a petition to take action 
     under section 201 of the Trade Act of 1974 (19 U.S.C. 2251) 
     to prevent further loss of market share due to the enormous 
     quantities of lamb being imported into the United States from 
     New Zealand and Australia;
       (4) on February 9, 1999, the International Trade Commission 
     voted unanimously that lamb imports are a threat to the sheep 
     industry in the United States;
       (5) on March 26, 1999, the International Trade Commission 
     voted to support 4 years of market stability in the marketing 
     of lamb meat;
       (6) several remedies have been offered to achieve this 
     market stability, including tariff rate quotas and ad-valorem 
     tariffs;
       (7) the efforts of the sheep industry in the United States 
     should be supported;
       (8) although international military issues have recently 
     consumed much time and consideration, with the Kosovo 
     agreement now in place, Congress should turn its attention to 
     domestic matters;
       (9) the problem of the overabundance of foreign lamb meat 
     in the United States has important consequences for imports 
     and international trade; and
       (10) the remedy that will provide the greatest practicable 
     assistance to the domestic lamb industry should be 
     implemented as soon as practicable.

                          ____________________