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(ii) any compensation received by such peer or entity in connection with the external review is reasonable and not contingent on any decision rendered by the peer or entity:

(iii) except as provided in paragraph (4), the plan and the issuer have no recourse against the peer or entity in connection with the external review; and

(iv) the peer or entity does not otherwise have a conflict of interest with a related party as determined under any regulations which the Secretary may prescribe.

(B) RELATED PARTY.-For purposes of this paragraph, the term “related party” means

(i) with respect to

(I) a group health plan or health insurance coverage offered in connection with such a plan, the plan or the health insurance issuer offering such coverage, or

(II) individual health insurance coverage, the health insurance issuer offering such coverage, or any plan sponsor, fiduciary, officer, director, or management employee of such plan or issuer;

(ii) the health care professional that provided the health care involved in the coverage decision;

(iii) the institution at which the health care involved in the coverage decision is provided:

(iv) the manufacturer of any drug or other item that was included in the health care involved in the coverage decision; or

(v) any other party determined under any regulations which the Secretary may prescribe to have a substantial interest in the coverage decision.

(4) LIMITATION ON LIABILITY OF REVIEWERS.-No qualified external appeal entity having a contract with a plan or issuer under this part and no person who is employed by any such entity or who furnishes professional services to such entity, shall be held by reason of the performance of any duty, function, or activity required or authorized pursuant to this section, to have violated any criminal law, or to be civilly liable under any law of the United States or of any State (or political subdivision thereof) if due care was exercised in the performance of such duty, function, or activity and there was no actual malice or gross misconduct in the performance of such duty, function, or activity.

(d) EXTERNAL APPEAL DETERMINATION BINDING ON PLAN.—The determination by an external appeal entity under this section is binding on the plan and issuer involved in the determination.

(e) PENALTIES AGAINST AUTHORIZED OFFICIALS FOR REFUSING TO AUTHORIZE THE DETERMINATION OF AN EXTERNAL REVIEW ENTITY.

(1) MONETARY PENALTIES.-In any case in which the determination of an external review entity is not followed by a group health plan, or by a health insurance issuer offering health insurance coverage, any person who, acting in the capacity of authorizing the benefit, causes such refusal may, in the discretion in a court of competent jurisdiction, be liable to an aggrieved participant, beneficiary, or enrollee for a civil penalty in an amount of up to $1,000 a day from the date on which the determination was transmitted to the plan or issuer by the external review entity until the date the refusal to provide the benefit is corrected.

(2) CEASE AND DESIST ORDER AND ORDER OF ATTORNEY'S FEES.-In any action described in paragraph (1) brought by a participant, beneficiary, or enrollee with respect to a group health plan, or a health insurance issuer offering health insurance coverage, in which a plaintiff alleges that a person referred to in such paragraph has taken an action result

ing in a refusal of a benefit determined by an external appeal entity in violation of such terms of the plan, coverage, or this subtitle, or has failed to take an action for which such person is responsible under the plan, coverage, or this title and which is necessary under the plan or coverage for authorizing a benefit, the court shall cause to be served on the defendant an order requiring the defendant

(A) to cease and desist from the alleged action or failure to act; and

(B) to pay to the plaintiff a reasonable attorney's fee and other reasonable costs relating to the prosecution of the action on the charges on which the plaintiff prevails.

(3) ADDITIONAL CIVIL PENALTIES.

(A) IN GENERAL.-In addition to any penalty imposed under paragraph (1) or (2), the appropriate Secretary may assess a civil penalty against a person acting in the capacity of authorizing a benefit determined by an external review entity for one or more group health plans, or health insurance issuers offering health insurance coverage, for

(i) any pattern or practice of repeated refusal to authorize a benefit determined by an external appeal entity in violation of the terms of such a plan, coverage, or this title; or

(ii) any pattern or practice of repeated violations of the requirements of this section with respect to such plan or plans or coverage.

(B) STANDARD OF PROOF AND AMOUNT OF PENALTY.-Such penalty shall be payable only upon proof by clear and convincing evidence of such pattern or practice and shall be in an amount not to exceed the lesser of

(i) 25 percent of the aggregate value of benefits shown by the appropriate Secretary to have not been provided, or unlawfully delayed, in violation of this section under such pattern or practice, or

(ii) $500,000.

(4) REMOVAL AND DISQUALIFICATION.—Any person acting in the capacity of authorizing benefits who has engaged in any such pattern or practice described in paragraph (3)(A) with respect to a plan or coverage, upon the petition of the appropriate Secretary, may be removed by the court from such position, and from any other involvement, with respect to such a plan or coverage, and may be precluded from returning to any such position or involvement for a period determined by the court.

(f) PROTECTION OF LEGAL RIGHTS.-Nothing in this subtitle shall be construed as altering or eliminating any cause of action or legal rights or remedies of participants, beneficiaries, enrollees, and others under State or Federal law (including sections 502 and 503 of the Employee Retirement Income Security Act of 1974), including the right to file judicial actions to enforce actions. SEC. 104. ESTABLISHMENT OF A 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 or without such consent if the individual is medically unable to provide such consent, regarding any aspect of the plan's or issuer's services.

(2) GRIEVANCE DEFINED.-In this section, the term “grievance" means any question, complaint, or concern brought by a participant, beneficiary or enrollee that is not a

claim for benefits (as defined in section 101(f)(1)).

(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. Grievances are not subject to appeal under the previous provisions of this subtitle.

Subtitle B—Access to Care SEC. 111. CONSUMER CHOICE OPTION.

(a) IN GENERAL.-If a health insurance issuer offers to enrollees health insurance coverage in connection with a group health plan which provides for coverage of services only if such services are furnished through health care professionals and providers who are members of a network of health care professionals and providers who have entered into a contract with the issuer to provide such services, the issuer shall also offer to such enrollees (at the time of enrollment and during an annual open season as provided under subsection (c)) the option of health insurance coverage which provides for coverage of such services which are not furnished through health care professionals and providers who are members of such a network unless enrollees are offered such nonnetwork coverage through another group health plan or through another health insurance issuer in the group market.

(b) ADDITIONAL COSTS.—The amount of any additional premium charged by the health insurance issuer for the additional cost of the creation and maintenance of the option described in subsection (a) and the amount of any additional cost sharing imposed under such option shall be borne by the enrollee unless it is paid by the health plan sponsor through agreement with the health insurance issuer.

(C) OPEN SEASON.—An enrollee may change to the offering provided under this section only during a time period determined by the health insurance issuer. Such time period shall occur at least annually. SEC. 112. CHOICE OF HEALTH CARE PROFES

SIONAL. (a) PRIMARY CARE. If a group health plan, or a health insurance issuer that offers health insurance coverage, requires or provides for designation by a participant, beneficiary, or enrollee of a participating primary care provider, then the plan or issuer shall permit each participant, beneficiary, and enrollee to designate 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 professional 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 health care professionals with respect to such care. SEC. 113. 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 services in an emergency department of a hospital, the plan or issuer shall cover emergency services (as defined in paragraph (2)(B))—

(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

(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, 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; 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.

(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.

(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 POST-STABILIZATION CARE.-If benefits are available under a group health plan, or under health insurance coverage offered by a health insurance issuer, with respect to maintenance care or post-stabilization care covered under the guidelines established under section 1852(d)(2) of the Social Security Act, 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 such guidelines). SEC. 114. 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 or an enrollee who is covered under health insurance coverage offered by a health insurance issuer,

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

(C) 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.

(2) SPECIALIST DEFINED.–For purposes of this subsection, the term “specialist” means, with respect to a condition, a health care practitioner, facility, or center 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.

(3) 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 paragraph (1) be

(A) 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

(B) 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.

(4) REFERRALS TO PARTICIPATING PROVIDERS.-A group health plan or health insurance issuer is not required under paragraph (1) 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.

(5) TREATMENT OF NONPARTICIPATING PROVIDERS.-If a plan or issuer 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, 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 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 individual'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 or issuer 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).

(C) STANDING REFERRALS.

(1) 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 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. 115. ACCESS TO OBSTETRICAL AND GYNECO

LOGICAL CARE. (a) 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 health care professional, the plan or issuer

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

(2) shall treat the ordering of other obstetrical or gynecological care by such a participating professional as the authorization of the primary care health care professional with respect to such care under the plan or coverage.

(b) CONSTRUCTION.—Nothing in subsection (a) shall be construed to

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

(2) preclude the group health plan or health insurance issuer involved from requiring that the obstetrical or gynecological provider notify the primary care health care professional or the plan or issuer of treatment decisions. SEC. 116. ACCESS TO PEDIATRIC CARE.

(a) PEDIATRIC CARE.-If a group health plan, or a health insurance issuer in connection with the provision of health insurance coverage, requires or provides for an enrollee

to designate a participating primary care provider for a child of such enrollee, the plan or issuer shall permit the enrollee to designate a physician who specializes 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 or health insurance coverage with respect to coverage of pediatric care. SEC. 117. 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)(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, beneficiary, or enrollee in the plan or coverage 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 or issuer 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 114(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 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 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, beneficiary, or enrollee 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, 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 or its medical manifestations.

(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 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 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. 118. ACCESS TO NEEDED PRESCRIPTION

DRUGS. 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)(5) to participants, beneficiaries, and enrollees, the nature of the formulary restrictions; and

(3) consistent with the standards for a utilization review program under section 101, provide for exceptions from the formulary limitation when a non-formulary alternative is medically indicated. SEC. 119. COVERAGE FOR INDIVIDUALS PARTICI.

PATING 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

(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.

Subtitle C-Access to Information SEC. 121. PATIENT ACCESS TO 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 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, 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 112(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.

(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.

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

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

(11) NOTICE OF REQUIREMENTS.-Notice of the requirements of this title.

(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 101, including under any drug formulary program under section 118.

(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.-A general description by category (including salary, fee-for-service, capitation, and such other categories as may be specified in regulations of the Secretary) of the applicable method by which a specified prospective or treating health care professional is (or would be) compensated in connection with the provision of health care under the plan or 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) FORMULARY RESTRICTIONS.-A description of the nature of any drug formula restrictions.

(6) 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. Subtitle D-Protecting the Doctor-Patient

Relationship SEC. 131. PROHIBITION OF INTERFERENCE WITH

CERTAIN MEDICAL COMMUNICA

TIONS. (a) 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 otherwise restrict a health care professional from advising such a participant, beneficiary, or enrollee 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 or coverage, 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. 132. PROHIBITION OF DISCRIMINATION

AGAINST PROVIDERS BASED ON LI

CENSURE. (a) IN GENERAL.-A group health plan and a health insurance issuer offering health insurance coverage 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 or health insurance 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 patients within an institutional health care termination not to pay for a particular medresponsibilities of the plan or issuer;

provider in the same manner as they apply ical treatment or service or the services of a (2) to override any State licensure or to the plan or issuer in relation to care, serv type of health care professional. scope-of-practice law; or

ices, or conditions provided to one or more (B) ENFORCEMENT OF PEER REVIEW PROTO(3) as requiring a plan or issuer that offers participants, beneficiaries, or enrollees; and COLS AND INTERNAL PROCEDURES.—Nothing in network coverage to include for participa for purposes of applying this sentence, any this subsection shall be construed to prohibit tion every willing provider who meets the reference to a plan or issuer is deemed a ref a plan, issuer, or provider from establishing terms and conditions of the plan or issuer. erence to the institutional health care pro and enforcing reasonable peer review or utiSEC. 133. PROHIBITION AGAINST IMPROPER IN vider.

lization review protocols or determining CENTIVE ARRANGEMENTS.

(2) GOOD FAITH ACTION.–For purposes of whether a protected health care professional (a) IN GENERAL.-A group health plan and a paragraph (1), a protected health care profes has complied with those protocols or from health insurance issuer offering health insur sional is considered to be acting in good establishing and enforcing internal proceance coverage may not operate any physi faith with respect to disclosure of informa dures for the purpose of addressing quality cian incentive plan (as defined in subpara tion or participation if, with respect to the concerns. graph (B) of section 1876(i)(8) of the Social information disclosed as part of the action (C) RELATION TO OTHER RIGHTS.—Nothing in Security Act) unless the requirements de (A) the disclosure is made on the basis of this subsection shall be construed to abridge scribed in clauses (i), (ii)(I), and (iii) of sub personal knowledge and is consistent with

rights of participants, beneficiaries, enrollparagraph (A) of such section are met with that degree of learning and skill ordinarily

ees, and protected health care professionals respect to such a plan. possessed by health care professionals with

under other applicable Federal or State laws. (b) APPLICATION.-For purposes of carrying the same licensure or certification and the

(7) PROTECTED HEALTH CARE PROFESSIONAL out paragraph (1), any reference in section same experience;

DEFINED.–For purposes of this subsection, 1876(i)(8) of the Social Security Act to the (B) the professional reasonably believes

the term “protected health care profesSecretary, an eligible organization, or an in the information to be true;

sional” means an individual who is a lidividual enrolled with the organization shall (C) the information evidences either a vio

censed or certified health care professional be treated as a reference to the applicable lation of a law, rule, or regulation, of an ap

and whom authority, a group health plan or health in plicable accreditation standard, or of a gen

(A) with respect to a group health plan or surance issuer, respectively, and a particierally recognized professional or clinical

health insurance issuer, is an employee of pant, beneficiary, or enrollee with the plan standard or that a patient is in imminent

the plan or issuer or has a contract with the or organization, respectively. hazard of loss of life or serious injury; and

plan or issuer for provision of services for (c) CONSTRUCTION.-Nothing in this section (D) subject to subparagraphs (B) and (C) of

which benefits are available under the plan shall be construed as prohibiting all capita paragraph (3), the professional has followed

or issuer; or tion and similar arrangements or all proreasonable internal procedures of the plan,

(B) with respect to an institutional health vider discount arrangements. issuer, or institutional health care provider

care provider, is an employee of the provider SEC. 134. PAYMENT OF CLAIMS. established for the purpose of addressing

or has a contract or other arrangement with A group health plan, and a health insurquality concerns before making the disclo

the provider respecting the provision of ance issuer offering group health insurance sure.

health care services. coverage, shall provide for prompt payment (3) EXCEPTION AND SPECIAL RULE.

Subtitle E-Definitions of claims submitted for health care services

(A) GENERAL EXCEPTION.–Paragraph (1) or supplies furnished to a participant, benedoes not protect disclosures that would vio

SEC. 151. DEFINITIONS. late Federal or State law or diminish or im

(a) INCORPORATION OF GENERAL DEFINIficiary, or enrollee with respect to benefits covered by the plan or issuer, in a manner

pair the rights of any person to the contin TIONS.—Except as otherwise provided, the

ued protection of confidentiality of commuconsistent with the provisions of sections

provisions of section 2791 of the Public 1816(c)(2) and 1842(c)(2) of the Social Security nications provided by such law.

Health Service Act shall apply for purposes Act (42 U.S.C. 1395h(c)(2) and 42 U.S.C.

(B) NOTICE OF INTERNAL PROCEDURES.-Sub of this title in the same manner as they 1395u(c)(2)), except that for purposes of this

apply for purposes of title XXVII of such paragraph (D) of paragraph (2) shall not

Act. section, subparagraph (C) of section 1816(c)(2)

apply unless the internal procedures in

volved are reasonably expected to be known (b) SECRETARY.-Except as otherwise proof the Social Security Act shall be treated as to the health care professional involved. For

vided, the term “Secretary” means the Secapplying to claims received from a participant, beneficiary, or enrollee as well as

retary of Health and Human Services, in conpurposes of this subparagraph, a health care claims referred to in such subparagraph.

professional is reasonably expected to know sultation with the Secretary of Labor and

of internal procedures if those procedures the term "appropriate Secretary” means the SEC. 135. PROTECTION FOR PATIENT ADVOCACY.

have been made available to the professional Secretary of Health and Human Services in (a) PROTECTION FOR USE OF UTILIZATION REthrough distribution or posting.

relation to carrying out this title under secVIEW AND GRIEVANCE PROCESS.-A group

(C) INTERNAL PROCEDURE EXCEPTION.-Sub tions 2706 and 2751 of the Public Health Servhealth plan, and a health insurance issuer

paragraph (D) of paragraph (2) also shall not ice Act and the Secretary of Labor in relawith respect to the provision of health insurapply if

tion to carrying out this title under section ance coverage, may not retaliate against a

(i) the disclosure relates to an imminent 713 of the Employee Retirement Income Separticipant, beneficiary, enrollee, or health

hazard of loss of life or serious injury to a curity Act of 1974. care provider based on the participant's, patient;

(c) ADDITIONAL DEFINITIONS.—For purposes beneficiary's, enrollee's or provider's use of,

(ii) the disclosure is made to an appro

of this title: or participation in, a utilization review proc

priate private accreditation body pursuant (1) ACTIVELY PRACTICING.–The term “acess or a grievance process of the plan or

to disclosure procedures established by the tively practicing” means, with respect to a issuer (including an internal or external rebody; or

physician or other health care professional, view or appeal process) under this title.

(iii) the disclosure is in response to an in such a physician or professional who pro(b) PROTECTION FOR QUALITY ADVOCACY BY

quiry made in an investigation or proceeding vides professional services to individual paHEALTH CARE PROFESSIONALS.

of an appropriate public regulatory agency tients on average at least two full days per (1) IN GENERAL.-A group health plan or

and the information disclosed is limited to week. health insurance issuer may not retaliate or

the scope of the investigation or proceeding. (2) APPLICABLE AUTHORITY.—The term “apdiscriminate against a protected health care

(4) ADDITIONAL CONSIDERATIONS.-It shall plicable authority” meansprofessional because the professional in good

not be a violation of paragraph (1) to take an (A) in the case of a group health plan, the faith

adverse action against a protected health Secretary of Health and Human Services and (A) discloses information relating to the

care professional if the plan, issuer, or pro the Secretary of Labor; and care, services, or conditions affecting one or

vider taking the adverse action involved (B) in the case of a health insurance issuer more participants, beneficiaries, or enrollees

demonstrates that it would have taken the with respect to a specific provision of this of the plan or issuer to an appropriate public

same adverse action even in the absence of title, the applicable State authority (as deregulatory agency, an appropriate private

the activities protected under such para fined in section 2791(d) of the Public Health accreditation body, or appropriate managegraph.

Service Act), or the Secretary of Health and ment personnel of the plan or issuer; or

(5) NOTICE.—A group health plan, health in Human Services, if such Secretary is enforc(B) initiates, cooperates, or otherwise par

surance issuer, and institutional health care ing such provision under section 2722(a)(2) or ticipates in an investigation or proceeding provider shall post a notice, to be provided 2761(a)(2) of the Public Health Service Act. by such an agency with respect to such care, or approved by the Secretary of Labor, set (3) CLINICAL PEER.—The term “clinical services, or conditions.

ting forth excerpts from, or summaries of, peer” means, with respect to a review or apIf an institutional health care provider is a the pertinent provisions of this subsection peal, an actively practicing

practicing physician participating provider with such a plan or and information pertaining to enforcement (allopathic or osteopathic) or other actively issuer or otherwise receives payments for of such provisions.

practicing health care professional who holds benefits provided by such a plan or issuer, (6) CONSTRUCTIONS.

a nonrestricted license, and who is approthe provisions of the previous sentence shall (A) DETERMINATIONS OF COVERAGE.—Noth priately credentialed in the same or similar apply to the provider in relation to care, ing in this subsection shall be construed to specialty or subspecialty (as appropriate) as services, or conditions affecting one or more prohibit a plan or issuer from making a de typically handles the medical condition, pro

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