procedure by which the dispute is resolved by binding arbitration which is available under the plan with respect to similarly situated participants and beneficiaries and which meets the requirements of subparagraph (B); or

"(II) in the case of any such plan or portion thereof which is established and maintained pursuant to a bona fide collective bargaining agreement, the plan provides for a procedure by which such disputes are resolved by means of binding arbitration which meets the requirements of subparagraph (B); and

"(ii) the additional requirements of subparagraph (B) are met.

"(B) ADDITIONAL REQUIREMENTS.-The Secretary shall prescribe by regulation requirements for arbitration procedures under this paragraph, including at least the following requirements:

"(i) ARBITRATION PANEL.-The arbitration shall be conducted by an arbitration panel meeting the requirements of subparagraph (C).

"(ii) FAIR PROCESS; DE NOVO DETERMINATION. The procedure shall provide for a fair, de novo determination.

"(iii) OPPORTUNITY TO SUBMIT EVIDENCE, HAVE REPRESENTATION, AND MAKE ORAL PRESENTATION.-Each party to the arbitration procedure

"(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. "(iv) PROVISION OF INFORMATION. The plan shall provide timely access to all its records relating to the matters under arbitration and to all provisions of the plan relating to such matters.

"(v) TIMELY DECISIONS.-A determination by the arbitration panel on the decision shall

"(I) be made in writing;

"(II) be binding on the parties; and "(III) be made in accordance with the medical exigencies of the case involved.

"(vi) EXHAUSTION OF EXTERNAL REVIEW REQUIRED. The arbitration procedures under this paragraph shall not be available to party unless the party has exhausted external review procedures under section 804. "(vii) VOLUNTARY ELECTION.-A health plan may not require, through the plan document, a contract, or otherwise, that a participant or beneficiary make the election described in subparagraph (A)(i)(I). "(C) ARBITRATION PANEL.—

group

"(i) IN GENERAL.-Arbitrations commenced pursuant to this paragraph shall be conducted by a panel of arbitrators selected by the parties made up of 3 individuals, including at least one practicing physician and one practicing attorney.

"(ii) QUALIFICATIONS.-Any individual who is a member of an arbitration panel shall meet the following requirements:

"(I) There is no real or apparent conflict of interest that would impede the individual conducting arbitration independent of the plan and meets the independence requirements of clause (iii).

"(II) The individual has sufficient medical or legal expertise to conduct the arbitration for the plan on a timely basis.

"(III) The individual has appropriate credentials and has attained recognized expertise in the applicable medical or legal field. "(IV) The individual was not involved in the initial adverse coverage decision or any other review thereof.

"(iii) INDEPENDENCE REQUIREMENTS.-An individual described in clause (ii) meets the independence requirements of this clause if"(I) the individual is not affiliated with any related party,

"(II) any compensation received by such individual in connection with the binding arbitration procedure is reasonable and not contingent on any decision rendered by the individual,

"(III) under the terms of the plan, the plan has no recourse against the individual or entity in connection with the binding arbitration procedure, and

"(IV) the individual does not otherwise have a conflict of interest with a related party as determined under such regulations as the Secretary may prescribe.

"(iv) RELATED PARTY.-For purposes of clause (iii), the term 'related party' means"(I) the plan or any health insurance issuer offering health insurance coverage in connection with the plan (or any officer, director, or management employee of such plan or issuer),

"(II) the physician or other medical care provider that provided the medical care involved in the coverage decision,

"(III) the institution at which the medical care involved in the coverage decision is provided,

"(IV) the manufacturer of any drug or other item that was included in the medical care involved in the coverage decision, or

"(V) any other party determined under such regulations as the Secretary may prescribe to have a substantial interest in the coverage decision.

"(iv) AFFILIATED.-For purposes of clause (iii), the term 'affiliated' means, in connection with any entity, having a familial, financial, or professional relationship with, or interest in, such entity.

"(D) DECISIONS.

"(i) IN GENERAL.-Decisions rendered by the arbitration panel shall be binding on all parties to the arbitration and shall be enforcible under section 502 as if the terms of the decision were the terms of the plan, except that the court may vacate any award made pursuant to the arbitration for any cause described in paragraph (1), (2), (3), (4), or (5) of section 10(a) of title 9, United States Code.

"(ii) ALLOWABLE REMEDIES.-The remedies which may be implemented by the arbitration panel shall consist of those remedies which would be available in an action timely commenced by a participant or beneficiary under section 502 after exhaustion of administrative remedies, except that a money award may be made in the arbitration proceedings in any amount not to exceed 3 times the maximum amount of damages that would be allowable in such case in an action described in section 502(n).”.

(b) EFFECTIVE DATE.-The amendment made by this section shall apply to adverse coverage decisions initially rendered by group health plans on or after the date of the enactment of this Act.

TITLE III- AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986 SEC. 301. APPLICATION TO GROUP HEALTH PLANS UNDER THE INTERNAL REVENUE CODE OF 1986.

Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended

(1) in the table of sections, by inserting after the item relating to section 9812 the following new item:

"Sec. 9902. Access to emergency care. "Sec. 9903. Access to specialty care. "Sec. 9904. Access to obstetrical and gynecological care.

"Sec. 9905. Access to pediatric care. "Sec. 9906. Continuity of care. "Sec. 9907. Network adequacy. "Sec. 9908. Access to experimental or investigational prescription drugs.

"Sec. 9909. Coverage for individuals participating in approved cancer clinical trials. "SEC. 9901. CHOICE OF HEALTH CARE PROFESSIONAL.

"(a) PRIMARY CARE.-If a group health plan requires or provides for designation by a participant or beneficiary of a participating primary care provider, then the plan shall permit each participant and beneficiary to designate any participating primary care provider who is available to accept such individual.

"(b) SPECIALISTS.-A group health plan shall permit each participant or beneficiary to receive medically necessary or appropriate specialty care, pursuant to appropriate referral procedures, from any qualified participating health care professional who is available to accept such individual for such care.

"SEC. 9902. ACCESS TO EMERGENCY CARE.

“(a) COVERAGE OF EMERGENCY SERVICES.— "(1) IN GENERAL.-If a group health plan provides or covers any benefits with respect to services in an emergency department of a hospital, the plan shall cover emergency services (as defined in paragraph (2)(B))—

"(A) without the need for any prior authorization determination;

"(B) whether 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 or beneficiary— "(i) by a nonparticipating health care provider with or without prior authorization, or "(ii) by a participating health care provider without prior authorization, 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 health care provider with prior authorization; 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.-The term 'emergency medical condition' means"(i) 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 reason

ably 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; and "(ii) a medical condition manifesting itself in a neonate by acute symptoms of sufficient severity (including severe pain) such that a prudent health care professional could reasonably expect the absence of immediate medical attention to result in a condition described in clause (i), (ii), or (iii) of section 1867(e)(1)(A) of the Social Security Act. "(B) EMERGENCY SERVICES.-The 'emergency services' means

term

"(i) with respect to an emergency medical condition described in subparagraph (A)(i)—

"(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 such emergency medical condition, 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; or

"(ii) with respect to an emergency medical condition described in subparagraph (A)(ii), medical treatment for such condition rendered by a health care provider in a hospital to a neonate, including available hospital ancillary services in response to an urgent request of a health care professional and to the extent necessary to stabilize the neonate.

"(C) STABILIZE. The term 'to stabilize' means, with respect to an emergency medical condition, to provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from a facility.

"(b) REIMBURSEMENT FOR MAINTENANCE CARE AND OST-STABILIZATION CARE.-If benefits are available under a group health plan with respect to maintenance care or poststabilization care covered under the guidelines established under section 1852(d)(2) of the Social Security Act, the plan shall provide for reimbursement with respect to such services provided to a participant or beneficiary other than through a participating health care provider in a manner consistent with subsection (a)(1)(C) (and shall otherwise comply with such guidelines).

"(c) COVERAGE OF EMERGENCY AMBULANCE SERVICES.

"(1) IN GENERAL.-If a group health plan provides any benefits with respect to ambulance services and emergency services, the plan shall cover emergency ambulance services (as defined in paragraph (2))) furnished under the plan under the same terms and conditions under subparagraphs (A) through (D) of subsection (a)(1) under which coverage is provided for emergency services.

"(2) EMERGENCY AMBULANCE SERVICES.-For purposes of this subsection, the term 'emergency ambulance services' means ambulance services (as defined for purposes of section 1861(s)(7) of the Social Security Act) furnished to transport an individual who has an emergency medical condition (as defined in subsection (a)(2)(A)) to a hospital for the receipt of emergency services (as defined in subsection (a)(2)(B)) in a case in which the emergency services are covered under the plan pursuant to subsection (a)(1) and a prudent layperson, with an average knowledge of health and medicine, could reasonably expect that the absence of such transport would result in placing the health of the individual in serious jeopardy, serious impairment of bodily function, or serious dysfunction of any bodily organ or part.

"SEC. 9903. ACCESS TO SPECIALTY CARE. "(a) SPECIALTY CARE FOR COVERED SERVICES.

"(1) IN GENERAL.-If

“(A) an individual is a participant or beneficiary under a group health plan,

"(B) the individual has a condition or disease of sufficient seriousness and complexity to require treatment by a specialist or the individual requires physician pathology services, and

"(C) benefits for such treatment or services are provided under the plan,

the plan shall make or provide for a referral to a specialist who is available and accessible (consistent with standards developed under section 9907) to provide the treatment for such condition or disease or to provide such services.

"(2) SPECIALIST DEFINED.-For purposes of this subsection, the term 'specialist' means, with respect to a condition or services, a health care practitioner, facility, or center or physician pathologist that has adequate expertise through appropriate training and experience (including, in the case of a child, appropriate pediatric expertise and in the case of a pregnant woman, appropriate obstetrical expertise) to provide high quality care in treating the condition or to provide physician pathology services.

"(3) CARE UNDER REFERRAL.-A group health plan may require that the care provided to an individual pursuant to such referral under paragraph (1) with respect to treatment be

"(A) pursuant to a treatment plan, only if the treatment plan is developed by the specialist and approved by the plan, in consultation with the designated primary care provider or specialist and the individual (or the individual's designee), and

"(B) in accordance with applicable quality assurance and utilization review standards of the plan.

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. "(4) REFERRALS VIDERS.-A group health plan is not required under paragraph (1) to provide for a referral to a specialist that is not a participating provider, unless the plan does not have a specialist that is available and accessible to treat the individual's condition or provide physician pathology services and that is a participating provider with respect to such. treatment or services.

ΤΟ PARTICIPATING PRO

"(5) REFERRALS TO NONPARTICIPATING PROVIDERS.-In a case in which a referral of an individual to a nonparticipating specialist is required under paragraph (1), the group health plan shall provide the individual the option of at least three nonparticipating specialists.

"(6) TREATMENT OF NONPARTICIPATING PROVIDERS.-If a plan refers an individual to a nonparticipating specialist pursuant to paragraph (1), 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.

"(b) SPECIALISTS AS GATEKEEPER FOR TREATMENT OF ONGOING SPECIAL CONDITIONS.

"(1) IN GENERAL.-A group health plan shall have a procedure by which an individual who is a participant or beneficiary and who has an ongoing special condition (as defined in paragraph (3)) may request and receive a referral to a specialist for such condition who shall be responsible for and capable of providing and coordinating the individ

ual's care with respect to the condition. Under such procedures if such an individual's care would most appropriately be coordinated by such a specialist, such plan shall refer the individual to such specialist.

"(2) TREATMENT FOR RELATED REFERRALS.— Such specialists 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 (referred to in subsection (a)(3)(A)) with respect to the ongoing special condition.

"(3) ONGOING SPECIAL CONDITION DEFINED.— In this subsection, the term 'ongoing special condition' means a condition or disease that

“(A) is life-threatening, degenerative, or disabling, and

"(B) requires specialized medical care over a prolonged period of time.

"(4) TERMS OF REFERRAL.-The provisions of paragraphs (3) through (5) of subsection (a) apply with respect to referrals under paragraph (1) of this subsection in the same manner as they apply to referrals under subsection (a)(1).

"(5) CONSTRUCTION.-Nothing in this subsection shall be construed as preventing an individual who is a participant or beneficiary and who has an ongoing special condition from having the individual's primary care physician assume the responsibilities for providing and coordinating care described in paragraph (1).

"(c) STANDING REFERRALS.

"(1) IN GENERAL.-A group health plan shall have a procedure by which an individual who is a participant or beneficiary 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 if the primary care provider in consultation with the medical director of the plan and the specialist (if any), determines that such a standing referral is appropriate, the plan shall make such a referral to such a specialist if the individual so desires.

"(2) TERMS OF REFERRAL.-The provisions of paragraphs (3) through (5) of subsection (a) apply with respect to referrals under paragraph (1) of this subsection in the same manner as they apply to referrals under subsection (a)(1).

"SEC. 9904. ACCESS TO OBSTETRICAL AND GYNECOLOGICAL CARE.

"(a) IN GENERAL.-If a group health plan requires or provides for a participant or beneficiary to designate a participating primary care health care professional, the plan—

“(1) may not require authorization or a referral by the the individual's primary care health care professional or otherwise for covered gynecological care (including preventive women's health examinations) or for covered pregnancy-related services provided by a participating physician (including a family practice physician) who specializes or is trained and experienced in gynecology or obstetrics, respectively, to the extent such care is otherwise covered; and

"(2) shall treat the ordering of other gynecological or obstetrical care by such a participating physician as the authorization of the primary care health care professional with respect to such care under the plan. "(b) CONSTRUCTION.-Nothing in subsection (a) shall be construed to

"(1) waive any exclusions of coverage under the terms of the plan with respect to coverage of gynecological or obstetrical care;

"(2) preclude the group health plan involved from requiring that the gynecologist

or obstetrician notify the primary care health care professional or the plan of treatment decisions; or

"(3) prevent a plan from offering, in addition to physicians described in subsection (a)(1), non-physician health care professionals who are trained and experienced in gynecology or obstetrics.

"SEC. 9905. ACCESS TO PEDIATRIC CARE.

"(a) PEDIATRIC CARE.-If a group health plan requires or provides for a participant or beneficiary to designate a participating primary care provider for a child of such individual, the plan shall permit the individual to designate a physician (including a family practice physician) who specializes or is trained and experienced in pediatrics as the child's primary care provider.

"(b) CONSTRUCTION.-Nothing in subsection (a) shall be construed to waive any exclusions of coverage under the terms of the plan with respect to coverage of pediatric care. "SEC. 9906. CONTINUITY OF CARE.

"(a) IN GENERAL.

"(1) TERMINATION OF PROVIDER.-If a contract between a group health plan and a health care provider is terminated (as defined in paragraph (3)(B)), 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 or beneficiary in the plan is undergoing treatment from the provider for an ongoing special condition (as defined in paragraph (3)(A)) at the time of such termination, the plan shall

"(A) notify the individual on a timely basis of such termination and of the right to elect continuation of coverage of treatment by the provider under this section; and

"(B) subject to subsection (c), permit the individual to elect to continue to be covered with respect to treatment by the provider of such condition 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) DEFINITIONS.-For purposes of this section:

"(A) ONGOING SPECIAL CONDITION.-The term 'ongoing special condition' has the meaning given such term in section 9903(b)(3), and also includes pregnancy.

"(B) TERMINATION.-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 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 up to 90 days (as determined by the treating health care professional) after the date of the notice described in subsection (a)(1)(A) of the provider's termination.

“(2) SCHEDULED SURGERY AND ORGAN TRANSPLANTATION.-If surgery or organ transplantation was scheduled for an individual 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 surgery or transplantation, the transitional period under this subsection with respect to the surgery or transplantation shall extend beyond the period under paragraph (1) and until the date of discharge of the individual after completion of the surgery or transplantation.

"(3) PREGNANCY.-If

"(A) a participant or beneficiary was determined to be pregnant 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 or beneficiary 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 or its medical manifestations.

"(c) PERMISSIBLE TERMS AND CONDITIONS.— A group health plan may condition coverage of continued treatment by a provider under subsection (a)(1)(B) upon the individual notifying the plan of the election of continued coverage and upon the provider agreeing to the following terms and conditions:

"(1) The provider agrees to accept reimbursement from the plan and individual involved (with respect to cost-sharing) at the rates applicable prior to the start of the transitional period as payment in full (or, in the case described in subsection (a)(2), at the rates applicable under the replacement plan 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 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) 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. 9907. NETWORK ADEQUACY.

"(a) REQUIREMENT.-A group health plan shall meet such standards for network adequacy as are established by law pursuant to this section.

"(b) DEVELOPMENT OF STANDARDS.—

"(1) ESTABLISHMENT OF PANEL.-There is established a panel to be known as the Health Care Panel to Establish Network Adequacy Standards (in this section referred to as the 'Panel').

"(2) DUTIES OF PANEL.-The Panel shall devise standards for group health plans and to ensure that

"(A) participants and beneficiaries have access to a sufficient number, mix, and distribution of health care professionals and providers; and

"(B) covered items and services are available and accessible to each participant and beneficiary

"(i) in the service area of the plan; "(ii) at a variety of sites of service;

"(iii) with reasonable promptness (including reasonable hours of operation and after hours services);

"(iv) with reasonable proximity to the residences or workplaces of participants and beneficiaries; and

“(v) in a manner that takes into account the diverse needs of such individuals and reasonably assures continuity of care.

"(c) MEMBERSHIP.

Panel

"(1) SIZE AND COMPOSITION.-The shall be composed of 15 members. The Secretary of Health and Human Services, the Majority Leader of the Senate, and the Speaker of House of Representatives shall each appoint 1 member from representatives of private insurance organizations, consumer groups, State insurance commissioners, State medical societies, and State medical specialty societies.

"(2) TERMS OF APPOINTMENT.-The members of the Panel shall serve for the life of the Panel.

"(3) VACANCIES.-A vacancy in the Panel shall not affect the power of the remaining members to execute the duties of the Panel, but any such vacancy shall be filled in the same manner in which the original appointment was made.

"(d) PROCEDURES.—

"(1) MEETINGS.-The Panel shall meet at the call of a majority of its members.

"(2) FIRST MEETING.-The Panel shall convene not later than 60 days after the date of the enactment of the Health Care Quality and Choice Act of 1999.

“(3) QUORUM.-A quorum shall consist of a majority of the members of the Panel.

"(4) HEARINGS.-For the purpose of carrying out its duties, the Panel may hold such hearings and undertake such other activities as the Panel determines to be necessary to carry out its duties.

"(e) ADMINISTRATION.—

"(1) COMPENSATION.-Except as provided in paragraph (1), members of the Panel shall receive no additional pay, allowances, or benefits by reason of their service on the Panel.

“(2) TRAVEL EXPENSES AND PER DIEM.-Each member of the Panel who is not an officer or employee of the Federal Government shall receive travel expenses and per diem in lieu of subsistence in accordance with sections 5702 and 5703 of title 5, United States Code.

“(3) CONTRACT AUTHORITY.-The Panel may contract with and compensate government and private agencies or persons for items and services, without regard to section 3709 of the Revised Statutes (41 U.S.C. 5).

"(4) USE OF MAILS.-The Panel may use the United States mails in the same manner and under the same conditions as Federal agencies and shall, for purposes of the frank, be considered a commission of Congress as described in section 3215 of title 39, United States Code.

“(5) ADMINISTRATIVE SUPPORT SERVICES.— Upon the request of the Panel, the Secretary of Health and Human Services shall provide to the Panel on a reimbursable basis such administrative support services as the Panel may request.

"(f) REPORT AND ESTABLISHMENT OF STANDARDS.-Not later than 2 years after the first meeting, the Panel shall submit a report to Congress and the Secretary of Health and Human Services detailing the standards devised under subsection (b) and recommendations regarding the implementation of such standards. Such standards shall take effect to the extent provided by Federal law enacted after the date of the submission of such report.

"(g) TERMINATION.-The Panel shall terminate on the day after submitting its report to the Secretary of Health and Human Services under subsection (f).

"SEC. 9908. ACCESS TO EXPERIMENTAL OR INVESTIGATIONAL PRESCRIPTION DRUGS. "No use of a prescription drug or medical device shall be considered experimental or investigational under a group health plan if such use is included in the labeling authorized by the U.S. Food and Drug Administration under section 505, 513 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or under section 351 of the Public Health Service Act (42 U.S.C. 262), unless such use is demonstrated to be unsafe or ineffective. "SEC. 9909. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CANCER CLINICAL TRIALS.

"(a) COVERAGE.—

"(1) IN GENERAL.-If a group health plan provides coverage to a qualified individual (as defined in subsection (b)), the plan

"(A) may not deny the individual participation in the clinical trial referred to in subsection (b)(2);

"(B) subject to subsections (b), (c), and (d), 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 individual'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 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 and who meets the following conditions: "(1)(A) The individual has been diagnosed with cancer.

"(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 individual 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 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 to be paid for by the sponsors of an approved clinical trial.

"(2) ROUTINE PATIENT CARE COSTS.-For purposes of this section

"(A) IN GENERAL.-The term 'routine patient care costs' includes the costs associ

ated with the provision of items and services that

"(i) would otherwise be covered under the group health plan if such items and services were not provided in connection with an approved clinical trial program; and

"(ii) are furnished according to the protocol of an approved clinical trial program. "(B) EXCLUSION.-Such term does include the costs associated with the provision of

"(i) an investigational drug or device, unless the Secretary has authorized the manufacturer of such drug or device to charge for such drug or device; or

"(ii) any item or service supplied without charge by the sponsor of the approved clinical trial program.

"(3) 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 would normally pay for comparable items or services under subparagraph (A).

"(d) APPROVED CLINICAL TRIAL DEFINED.— In this section, the term 'approved clinical trial' means a cancer clinical research study or cancer clinical investigation approved by an Institutional Review Board.

"(e) CONSTRUCTION.-Nothing in this section shall be construed to limit a plan's coverage with respect to clinical trials. "(f) PLAN SATISFACTION OF CERTAIN REQUIREMENTS; RESPONSIBILITIES OF FIDUCIARIES.

"(1) IN GENERAL.-For purposes of this section, 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 requirements of this section 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.

"(2) CONSTRUCTION.-Nothing in this section shall be construed to affect or modify the responsibilities of the fiduciaries of a group health plan under part 4 of subtitle B of the Employee Retirement Income Security Act of 1974.

"Subchapter B-Access to Information "Sec. 9911. Patient access to information. "SEC. 9911. PATIENT ACCESS TO INFORMATION. "(a) DISCLOSURE REQUIREMENT.-A group health plan shall

"(1) 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);

"(2) provide to participants and beneficiaries, within a reasonable period (as specified by the Secretary) before or after the date of significant changes in the information described in subsection (b), information on such significant changes; and

"(3) upon request, make available to participants and beneficiaries, the Secretary, and prospective participants and beneficiaries, the information described in subsection (b) or (c).

The plan may charge a reasonable fee for provision in printed form of any of the information described in subsection (b) or (c) more than once during any plan year.

"(b) INFORMATION PROVIDED.-The information described in this subsection with respect to a group health plan shall be provided to a participant or beneficiary free of charge at least once a year and includes the following: "(1) SERVICE AREA.-The service area of the plan.

"(2) BENEFITS.-Benefits offered under the plan, including

"(A) those that are covered benefits "(all of which shall be referred to by such relevant CPT and DRG codes as are available), limits and conditions on such benefits, and those benefits that are explicitly excluded from coverage (all of which shall be referred to by such relevant CPT and DRG codes as are available);

"(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 nonparticipating 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 or beneficiary may select from among participating providers and the types of providers participating in the plan 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.

"(B) Out-of-network coverage (if any) provided by the plan.

"(C) Any point-of-service option (including any supplemental premium or cost-sharing for such option).

"(D) The procedures for participants and beneficiaries 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 9901(b)(2).

"(4) OUT-OF-AREA COVERAGE.-Out-of-area coverage provided by the plan.

"(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 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) PRIOR AUTHORIZATION RULES.-Rules regarding prior authorization or other review requirements that could result in noncoverage or nonpayment.

"(7) GRIEVANCE AND APPEALS PROCEDURES. All appeal or grievance rights and procedures under the plan, including the method for filing grievances and the time frames and circumstances for acting on grievances and appeals.

"(8) ACCOUNTABILITY.-A description of the legal recourse options available for participants and beneficiaries under the plan including

"(A) the preemption that applies under section 514 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1144) to certain actions arising out of the provision of health benefits; and

"(B) the extent to which coverage decisions made by the plan are subject to inter

nal review or any external review and the proper time frames under

"(9) QUALITY ASSURANCE.-Any information made public by an accrediting organization in the process of accreditation of the plan or any additional quality indicators the plan makes available.

"(10) INFORMATION ON TREATMENT AUTHORIZATION.-Notice of appropriate mailing addresses and telephone numbers to be used by participants and beneficiaries in seeking information or authorization for treatment.

"(11) 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 maintained by the plan. "(2) GRIEVANCE INFORMAAND APPEALS TION. Information on the number of grievances and appeals and on the disposition in the aggregate of such matters.

"(3) FORMULARY RESTRICTIONS.-A description of the nature of any drug formula restrictions.

"(4) PARTICIPATING PROVIDER LIST.-A list of current participating health care providers.

"(d) 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.

"Subchapter C-Protecting the Doctor-
Patient Relationship

"Sec. 9921. Prohibition of interference with certain medical communications.

"Sec. 9922. Prohibition of discrimination against providers based on li

censure.

"Sec. 9923. Prohibition against improper incentive arrangements.

"Sec. 9924. Payment of clean claims.
"SEC. 9921. PROHIBITION OF INTERFERENCE

WITH CERTAIN MEDICAL COMMU-
NICATIONS.

"(a) GENERAL RULE.-The provisions of any contract or agreement, or the operation of any contract or agreement, between a group health plan (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 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 individual or medical care or treatment for the individual's condition or disease, regardless of whether benefits for such care or treatment are provided under the plan, if the professional is acting within the lawful scope of practice.

"(b) NULLIFICATION.-Any contract provision or agreement that restricts or prohibits medical communications in violation of subsection (a) shall be null and void. "SEC. 9922. PROHIBITION OF DISCRIMINATION AGAINST PROVIDERS BASED ON LICENSURE.

"(a) IN GENERAL.-A group health plan 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.

"(b) CONSTRUCTION.-Subsection (a) shall not be construed

"(1) as requiring the coverage under a group health plan of particular benefits or services or to prohibit a plan from including providers only to the extent necessary to meet the needs of the plan's participants or beneficiaries or from establishing any measure designed to maintain quality and control costs consistent with the responsibilities of the plan;

"(2) to override any State licensure or scope-of-practice law;

"(3) as requiring a plan that offers network coverage to include for participation every willing provider who meets the terms and conditions of the plan; or

"(4) as prohibiting a family practice physician with appropriate expertise from providing pediatric or obstetrical or gynecological care.

"SEC. 9923. PROHIBITION AGAINST IMPROPER INCENTIVE ARRANGEMENTS.

"(a) IN GENERAL.-A group health plan 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 clauses (i), (ii)(I), and (iii) of subparagraph (A) of such section are met with respect to such a plan.

"(b) 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 Secretary of the Treasury, a group health plan, and a participant or beneficiary with the plan, respectively.

"(c) CONSTRUCTION.-Nothing in this section shall be construed as prohibiting all capitation and similar arrangements or all provider discount arrangements. "SEC. 9924. PAYMENT OF CLEAN CLAIMS.

"A group health plan shall provide for prompt payment of claims submitted for health care services or supplies furnished to a participant or beneficiary with respect to benefits covered by the plan, in a manner consistent with the provisions of sections 1816(c)(2) and 1842(c)(2) of the Social Security Act (42 U.S.C. 1395h(c)(2) and 42 U.S.C. 1395u(c)(2)), except that for purposes of this section, subparagraph (C) of section 1816(c)(2) of the Social Security Act shall be treated as applying to claims received from a participant or beneficiary as well as claims referred to in such subparagraph.

"Subchapter D-Definitions "Sec. 9931. Definitions. "Sec. 9933. Exclusions.

"Sec. 9933. Coverage of limited scope plans. "Sec. 9934. Regulations; coordination; application under different laws.

"SEC. 9931. DEFINITIONS.

For purposes of this chapter— "(a) INCORPORATION OF GENERAL DEFINITIONS. Except as otherwise provided, the provisions of section 9831 shall apply for purposes of this chapter in the same manner as they apply for purposes of chapter 100.

"(b) ADDITIONAL DEFINITIONS.-For purposes of this chapter:

"(1) CLINICAL PEER.-The term 'clinical peer' means, with respect to a review or appeal, a practicing physician or other health care professional who holds a nonrestricted license and who is

"(A) appropriately certified by a nationally recognized, peer reviewed accrediting body in the same or similar specialty as typically manages the medical condition, procedure, or treatment under review or appeal, or

"(B) is trained and experienced in managing such condition, procedure, or treatment,

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 recommended or rendered by a physician.

"(2) HEALTH CARE PROFESSIONAL.-The term 'health care professional' means an individual who is licensed, accredited, or certified under State law to provide specified health care services and who is operating within the scope of such licensure, accreditation, or certification.

"(3) HEALTH CARE PROVIDER.-The term 'health care provider' includes a physician or other health care professional, as well as an institutional or other facility or agency that provides health care services and that is licensed, accredited, or certified to provide health care items and services under applicable State law.

"(4) NETWORK.-The term 'network' means, with respect to a group health plan, the participating health care professionals and providers through whom the plan provides health care items and services to participants or beneficiaries.

"(5) NONPARTICIPATING.-The term 'nonparticipating' means, with respect to a health care provider that provides health care items and services to a participant or beneficiary under group health plan, a health care provider that is not a participating health care provider with respect to such items and services.

"(6) PARTICIPATING.-The term 'participating' means, with respect to a health care provider that provides health care items and services to a participant or beneficiary under group health plan, a health care provider that furnishes such items and services under a contract or other arrangement with the plan.

"(7) PHYSICIAN.-The term 'physician' means an allopathic or osteopathic physician.

"(8) PRACTICING PHYSICIAN.-The term 'practicing physician' means a physician who is licensed in the State in which the physician furnishes professional services and who provides professional services to individual patients on average at least two full days per week.

"(9) PRIOR AUTHORIZATION.-The term 'prior authorization' means the process of obtaining prior approval from a group health plan for the provision or coverage of medical services.

"SEC. 9932. EXCLUSIONS.

"(a) NO BENEFIT REQUIREMENTS.-Nothing in this chapter shall be construed to require a group health plan to provide specific benefits under the terms of such plan, other than those provided under the terms of such plan. "(b) EXCLUSION FOR FEE-FOR-SERVICE COVERAGE.

"(1) GROUP HEALTH PLANS.-The provisions of sections 9901 through 9911 shall not apply to a group health plan if the only coverage offered under the plan is fee-for-service coverage (as defined in paragraph (2)).

"(2) FEE-FOR-SERVICE COVERAGE DEFINED.— For purposes of this subsection, the term 'fee-for-service coverage' means coverage under a group health plan that—

"(A) reimburses hospitals, health professionals, and other providers on a fee-for-service basis without placing the provider at financial risk;

"(B) does not vary reimbursement for such a provider based on an agreement to contract terms and conditions or the utilization of health care items or services relating to such provider;

"(C) allows access to any provider that is lawfully authorized to provide the covered services and agree to accept the terms and conditions of payment established under the plan; and

"(D) for which the plan does not require prior authorization before providing for any health care services.