"Sec. 819. Access to experimental or inprescription vestigational drugs. "Sec. 820. Coverage for individuals participating in approved cancer clinical trials. "SUBPART C-ACCESS TO INFORMATION "Sec. 821. Patient access to information. "SUBPART D-PROTECTING THE DOCTOR PATIENT RELATIONSHIP "Sec. 831. Prohibition of interference with certain medical communications. "Sec. 832. Prohibition of discrimination against providers based on licensure. "Sec. 833. Prohibition against improper incentive arrangements. "Sec. 834. Payment of clean claims. "SUBPART E-DEFINITIONS "Sec. 841. Definitions. "Sec. 842. Rule of construction. "Sec. 843. Exclusions. "Sec. 9916. Access to pediatric care. "Sec. 9917. Continuity of care. "Sec. 9918. Network adequacy. "Sec. 9919. Access to experimental or investigational prescription drugs. "Sec. 9920. Coverage for individuals participating in approved cancer clinical trials. "SUBCHAPTER C-ACCESS TO INFORMATION "Sec. 9921. Patient access to information. "SUBCHAPTER D-PROTECTING THE DOCTOR PATIENT RELATIONSHIP "Sec. 9931. Prohibition of interference with certain medical communications. "Sec. 9932. Prohibition of discrimination against providers based on li censure. "Sec. 9933. Prohibition against improper "SUBCHAPTER E-DEFINITIONS "Sec. 9941. Definitions. "Sec. 9942. Exclusions. "Sec. 9943. Coverage of limited scope plans. "Sec. 9944. Regulations. TITLE IV-EFFECTIVE DATES; COORDINATION IN IMPLEMENTATION Sec. 401. Effective dates. Sec. 402. Coordination in implementation. TITLE V-OTHER PROVISIONS Subtitle A-Protection of Information Sec. 501. Protection for certain information. Subtitle B-Other Matters Sec. 511. Health care paperwork simplification. TITLE I- AMENDMENTS TO THE PUBLIC SEC. 101. APPLICATION TO GROUP HEALTH (a) IN GENERAL.-Subpart 2 of part A of title XXVII of the Public Health Service Act is amended by adding at the end the following new section: “SEC. 2707. PATIENT PROTECTION STANDARDS. "(a) IN GENERAL.-Each group health plan shall comply with patient protection requirements under title XXVIII, and each health insurance issuer shall comply with patient protection requirements under such title with respect to group health insurance coverage it offers, and such requirements shall be deemed to be incorporated into this subsection. "(b) NOTICE.-A group health plan shall comply with the notice requirement under section 711(d) of the Employee Retirement Income Security Act of 1974 (as in effect on the date of the enactment of the Health Care Quality and Choice Act of 1999) with respect to the requirements referred to in subsection (a) and a health insurance issuer shall comply with such notice requirement as if such section applied to such issuer and such issuer were a group health plan.". (b) CONFORMING AMENDMENT.-Section 2721(b)(2)(A) of such Act (42 U.S.C. 300gg21(b)(2)(A)) is amended by inserting "(other than section 2707)" after "requirements of such subparts". SEC. 102. APPLICATION TO INDIVIDUAL HEALTH INSURANCE COVERAGE. Part B of title XXVII of the Public Health Service Act is amended by inserting after section 2752 the following new section: "SEC. 2753. PATIENT PROTECTION STANDARDS. "(a) IN GENERAL.-Each health insurance issuer shall comply with patient protection requirements under title XXVIII with respect to individual health insurance coverage it offers, and such requirements shall be deemed to be incorporated into this subsection. "(b) NOTICE.-A health insurance issuer under this part shall comply with the notice requirement under section 711(d) of the Employee Retirement Income Security Act of 1974 with respect to the requirements of such title as if such section applied to such issuer and such issuer were a group health plan.”. SEC. 103. IMPROVING MANAGED CARE. The Public Health Service Act is amended by adding at the end the following new title: "TITLE XXVIII-IMPROVING MANAGED CARE "Subtitle A-Grievance and Appeals "SEC. 2801. UTILIZATION REVIEW ACTIVITIES. "(a) COMPLIANCE WITH REQUIREMENTS.— “(1) IN GENERAL.-A group health plan, and a health insurance issuer that provides health insurance coverage, shall conduct utilization review activities in connection with the provision of benefits under such plan or coverage only in accordance with a utilization review program that meets the requirements of this section. "(2) USE OF OUTSIDE AGENTS.-Nothing in this section shall be construed as preventing a group health plan or health insurance issuer from arranging through a contract or otherwise for persons or entities to conduct utilization review activities on behalf of the plan or issuer, so long as such activities are conducted in accordance with a utilization review program that meets the requirements of this section. “(3) UTILIZATION REVIEW DEFINED. For purposes of this section, the terms 'utilization review' and 'utilization review activities' mean procedures used to monitor or evaluate the use or coverage, clinical necessity, appropriateness, efficacy, or efficiency of health care services, procedures or settings, and includes prospective review, concurrent review, second opinions, case management, discharge planning, or retrospective review. "(b) WRITTEN POLICIES AND CRITERIA.— "(1) WRITTEN POLICIES.-A utilization review program shall be conducted consistent with written policies and procedures that govern all aspects of the program. "(2) USE OF WRITTEN CRITERIA.— "(A) IN GENERAL.-Such a program shall utilize written clinical review criteria developed with input from a range of appropriate practicing physicians, as determined by the plan, pursuant to the program. Such criteria shall include written clinical review criteria that are based on valid clinical evidence where available and that are directed specifically at meeting the needs of at-risk populations and covered individuals with chronic conditions or severe illnesses, including gender-specific criteria and pediatric-specific criteria where available and appropriate. "(B) CONTINUING USE OF STANDARDS IN RETROSPECTIVE REVIEW.-If a health care service has been specifically pre-authorized or approved for an enrollee under such a program, the program shall not, pursuant to retrospective review, revise or modify the specific standards, criteria, or procedures used for the utilization review for procedures, treatment, and services delivered to the enrollee during the same course of treatment. "(C) REVIEW OF SAMPLE OF CLAIMS DENIALS. Such a program shall provide for periodic evaluation at reasonable intervals of the clinical appropriateness of a sample of denials of claims for benefits. "(c) CONDUCT OF PROGRAM ACTIVITIES.— "(1) ADMINISTRATION BY HEALTH CARE PROFESSIONALS.-A utilization review program shall be administered by appropriate physician specialists who shall be selected by the plan or issuer and who shall oversee review decisions. "(2) USE OF QUALIFIED, INDEPENDENT PERSONNEL. “(A) IN GENERAL.-A utilization review program shall provide for the conduct of utilization review activities only through personnel who are qualified and have received appropriate training in the conduct of such activities under the program. "(B) PROHIBITION OF CONTINGENT COMPENSATION ARRANGEMENTS.-Such a program shall not, with respect to utilization review activities, permit or provide compensation or anything of value to its employees, agents, or contractors in a manner that encourages denials of claims for benefits. This subparagraph shall not preclude any capitation arrangements between plans and providers. "(C) PROHIBITION OF CONFLICTS.-Such a program shall not permit a health care professional who is providing health care services to an individual to perform utilization review activities in connection with the health care services being provided to the individual. "(3) ACCESSIBILITY OF REVIEW.-Such a program shall provide that appropriate personnel performing utilization review activities under the program, including the utilization review administrator, are reasonably accessible by toll-free telephone during normal business hours to discuss patient care and allow response to telephone requests, and that appropriate provision is made to receive and respond promptly to calls received during other hours. "(4) LIMITS ON FREQUENCY.-Such a program shall not provide for the performance of utilization review activities with respect to a class of services furnished to an individual more frequently than is reasonably required to assess whether the services under review are medically necessary or appropriate. "(d) DEADLINE FOR DETERMINATIONS."(1) PRIOR AUTHORIZATION SERVICES."(A) IN GENERAL.-Except as provided in paragraph (2), in the case of a utilization review activity involving the prior authorization of health care items and services for an individual, the utilization review program shall make a determination concerning such authorization, and provide notice of the determination to the individual or the individual's designee and the individual's health care provider by telephone and in printed or electronic form, no later than the deadline specified in subparagraph (B). The provider involved shall provide timely access to information relevant to the matter of the review decision. "(B) DEADLINE. "(i) IN GENERAL.-Subject to clauses (ii) and (iii), the deadline specified in this subparagraph is 14 days after the earliest date as of which the request for prior authorization has been received and all necessary information has been provided. "(ii) EXTENSION PERMITTED WHERE NOTICE OF ADDITIONAL INFORMATION REQUIRED.—If a utilization review program "(I) receives a request for a prior authorization, "(II) determines that additional information is necessary to complete the review and make the determination on the request, "(III) notifies the requester, not later than 5 business days after the date of receiving the request, of the need for such specified additional information, and "(IV) requires the requester to submit specified information not later than 2 business days after notification, the deadline specified in this subparagraph is 14 days after the date the program receives the specified additional information, but in no case later than 28 days after the date of receipt of the request for the prior authorization. This clause shall not apply if the deadline is specified in clause (iii). "(iii) EXPEDITED CASES.-In the case of a situation described in section 102(c)(1)(A), the deadline specified in this subparagraph is 48 hours after the time of the request for prior authorization. "(2) ONGOING CARE.— "(A) CONCURRENT REVIEW. “(i) IN GENERAL.-Subject to subparagraph (B), in the case of a concurrent review of ongoing care (including hospitalization), which results in a termination or reduction of such care, the plan must provide by telephone and in printed or electronic form notice of the concurrent review determination to the individual or the individual's designee and the individual's health care provider as soon as possible in accordance with the medical exigencies of the case, with sufficient time prior to the termination or reduction to allow for an appeal under section 102(c)(1)(A) to be completed before the termination or reduction takes effect. "(ii) CONTENTS OF NOTICE.-Such notice shall include, with respect to ongoing health care items and services, the number of ongoing services approved, the new total of approved services, the date of onset of services, and the next review date, if any, as well as a statement of the individual's rights to further appeal. "(B) EXCEPTION.-Subparagraph (A) shall not be interpreted as requiring plans or issuers to provide coverage of care that would exceed the coverage limitations for such care. "(3) PREVIOUSLY PROVIDED SERVICES.-In the case of a utilization review activity involving retrospective review of health care services previously provided for an indi vidual, the utilization review program shall make a determination concerning such services, and provide notice of the determination to the individual or the individual's designee and the individual's health care provider by telephone and in printed or electronic form, within 30 days of the date of receipt of information that is reasonably necessary to make such determination, but in no case later than 60 days after the date of receipt of the claim for benefits. "(4) FAILURE TO MEET DEADLINE.-In a case in which a group health plan or health insurance issuer fails to make a determination on a claim for benefit under paragraph (1), (2)(A), or (3) by the applicable deadline established under the respective paragraph, the failure shall be treated under this subtitle as a denial of the claim as of the date of the deadline. “(5) REFERENCE TO SPECIAL RULES FOR EMERGENCY SERVICES, MAINTENANCE CARE, POST-STABILIZATION CARE, AND EMERGENCY AMBULANCE SERVICES.-For waiver of prior authorization requirements in certain cases involving emergency services, maintenance care and post-stabilization care, and emergency ambulance services, see subsections (a)(1), (b), and (c)(1) of section 113, respectively. "(e) NOTICE OF DENIALS OF CLAIMS FOR BENEFITS. “(1) IN GENERAL.-Notice of a denial of claims for benefits under a utilization review program shall be provided in printed or electronic form and written in a manner calculated to be understood by the participant, beneficiary, or enrollee and shall include_ "(A) the reasons for the denial (including the clinical rationale); "(B) instructions on how to initiate an appeal under section 102; and "(C) notice of the availability, upon request of the individual (or the individual's designee) of the clinical review criteria relied upon to make such denial. "(2) SPECIFICATION OF ANY ADDITIONAL INFORMATION.-Such a notice shall also specify what (if any) additional necessary information must be provided to, or obtained by, the person making the denial in order to make a decision on such an appeal. “(f) CLAIM FOR BENEFITS AND DENIAL OF CLAIM FOR BENEFITS DEFINED. For purposes of this subtitle: “(1) CLAIM FOR BENEFITS.—The term 'claim for benefits' means any request for coverage (including authorization of coverage), or for payment in whole or in part, for an item or service under a group health plan or health insurance coverage. "(2) DENIAL OF CLAIM FOR BENEFITS.-The term 'denial' means, with respect to a claim for benefits, a denial, or a failure to act on a timely basis upon, in whole or in part, the claim for benefits and includes a failure to provide or pay for benefits (including items and services) required to be provided or paid for under this title. "SEC. 2802. INTERNAL APPEALS PROCEDURES. "(a) RIGHT OF REVIEW. "(1) IN GENERAL.-Each group health plan, and each health insurance issuer offering health insurance coverage "(A) shall provide adequate notice in written or electronic form to any participant or beneficiary under such plan, or enrollee under such coverage, whose claim for benefits under the plan or coverage has been denied "(within the meaning of section 2801(f)(2)), setting forth the specific reasons for such denial of claim for benefits and rights to any further review or appeal, written in layman's terms to be understood by the participant, beneficiary, or enrollee; and "(B) shall afford such a participant, beneficiary, or enrollee (and any provider or other person acting on behalf of such an indi vidual with the individual's consent or without such consent if the individual is medically unable to provide such consent) who is dissatisfied with such a denial of claim for benefits a reasonable opportunity of not less than 180 days to request and obtain a full and fair review by a named fiduciary (with respect to such plan) or named appropriate individual (with respect to such coverage) of the decision denying the claim. "(2) TREATMENT OF ORAL REQUESTS.-The request for review under paragraph (1)(B) may be made orally, but, in the case of an oral request, shall be followed by a request in written or electronic form. "(b) INTERNAL REVIEW PROCESS."(1) CONDUCT OF REVIEW. "(A) IN GENERAL.-A review of a denial of claim under this section shall be made by an individual (who shall be a physician in a case involving medical judgment) who has been selected by the plan or issuer and who did not make the initial denial in the internally appealable decision, except that in the case of limited scope coverage (as defined in subparagraph (B)) an appropriate specialist shall review the decision. "(B) LIMITED SCOPE COVERAGE DEFINED.— For purposes of subparagraph (A), the term 'limited scope coverage' means a group health plan or health insurance coverage the only benefits under which are for benefits described in section 2791(c)(2)(A) of the Public Health Service Act (42 U.S.C. 300gg-91(c)(2)). "(2) TIME LIMITS FOR INTERNAL REVIEWS.— "(A) IN GENERAL.-Having received such a request for review of a denial of claim, the plan or issuer shall, in accordance with the medical exigencies of the case but not later than the deadline specified in subparagraph (B), complete the review on the denial and transmit to the participant, beneficiary, enrollee, or other person involved a decision that affirms, reverses, or modifies the denial. If the decision does not reverse the denial, the plan or issuer shall transmit, in printed or electronic form, a notice that sets forth the grounds for such decision and that includes a description of rights to any further appeal. Such decision shall be treated as the final decision of the plan. Failure to issue such a decision by such deadline shall be treated as a final decision affirming the denial of claim. “(B) DEADLINE.— "(i) IN GENERAL.-Subject to clauses (ii) and (iii), the deadline specified in this subparagraph is 14 days after the earliest date as of which the request for prior authorization has been received and all necessary information has been provided. The provider involved shall provide timely access to information relevant to the matter of the review decision. "(ii) EXTENSION PERMITTED WHERE NOTICE OF ADDITIONAL INFORMATION REQUIRED.—If a group health plan or health insurance issuer "(I) receives a request for internal review, "(II) determines that additional information is necessary to complete the review and make the determination on the request, “(III) notifies the requester, not later than 5 business days after the date of receiving the request, of the need for such specified additional information, and "(IV) requires the requester to submit specified information not later than 48 hours after notification, the deadline specified in this subparagraph is 14 days after the date the plan or issuer receives the specified additional information, but in no case later than 28 days after the date of receipt of the request for the internal review. This clause shall not apply if the deadline is specified in clause (iii). "(iii) EXPEDITED CASES.-In the case of a situation described in subsection (c)(1)(A), the deadline specified in this subparagraph is 48 hours after the time of request for review "(c) EXPEDITED REVIEW PROCESS. "(1) IN GENERAL.-A group health plan, and a health insurance issuer, shall establish procedures in writing for the expedited consideration of requests for review under subsection (b) in situations "(A) in which, as determined by the plan or issuer or as certified in writing by a treating physician, the application of the normal timeframe for making the determination could seriously jeopardize the life or health of the participant, beneficiary, or enrollee or such individual's ability to regain maximum function; or "(B) described in section 2801(d)(2) (relating to requests for continuation of ongoing care which would otherwise be reduced or terminated). "(2) PROCESS.-Under such procedures— "(A) the request for expedited review may be submitted orally or in writing by an individual or provider who is otherwise entitled to request the review; "(B) all necessary information, including the plan's or issuer's decision, shall be transmitted between the plan or issuer and the requester by telephone, facsimile, or other similarly expeditious available method; and "(C) the plan or issuer shall expedite the review in the case of any of the situations described in subparagraph (A) or (B) of paragraph (1). "(3) DEADLINE FOR DECISION.-The decision on the expedited review must be made and communicated to the parties as soon as possible in accordance with the medical exigencies of the case, and in no event later than 48 hours after the time of receipt of the request for expedited review, except that in a case described in paragraph (1)(B), the decision must be made before the end of the approved period of care. "(d) WAIVER OF PROCESS.-A plan or issuer may waive its rights for an internal review under subsection (b). In such case the participant, beneficiary, or enrollee involved (and any designee or provider involved) shall be relieved of any obligation to complete the review involved and may, at the option of such participant, beneficiary, enrollee, designee, or provider, proceed directly to seek further appeal through any applicable external appeals process. "SEC. 2803. EXTERNAL APPEALS PROCEDURES. "(a) RIGHT TO EXTERNAL APPEAL. "(1) IN GENERAL.-A group health plan, and a health insurance issuer offering health insurance coverage, shall provide for an external appeals process that meets the requirements of this section in the case of an externally appealable decision described in paragraph (2), for which a timely appeal is made (within a reasonable period not to exceed 365 days) either by the plan or issuer or by the participant, beneficiary, or enrollee (and any provider or other person acting on behalf of such an individual with the individual's consent or without such consent if such an individual is medically unable to provide such consent). "(2) EXTERNALLY APPEALABLE DECISION DEFINED. "(A) IN GENERAL.-For purposes of this section, the term 'externally appealable decision' means a denial of claim for benefits (as defined in section 2801(f)(2)), if— "(i) the item or service involved is covered under the plan or coverage, "(ii) the amount involved exceeds $100, increased or decreased, for each calendar year that ends after December 31, 2001, by the same percentage as the percentage by which the medical care expenditure category of the Consumer Price Index for All Urban Consumers (United States city average), published by the Bureau of Labor Statistics, for September of the preceding calendar year has increased or decreased from such index for September 2000, and "(iii) the requirements of subparagraph (B) are met with respect to such denial. Such term also includes a failure to meet an applicable deadline for internal review under section 2802 or such standards as are established pursuant to section 2818. "(B) REQUIREMENTS.-For purposes of subparagraph (A)(iii), the requirements of this subparagraph are met with respect to a denial of a claim for benefits if— "(i) the denial is based in whole or in part on a decision that the item or service is not medically necessary or appropriate or is investigational or experimental, or "(ii) in such denial, the decision as to whether an item or service is covered involves a medical judgment. "(C) EXCLUSIONS.-The term 'externally appealable decision' does not include "(i) specific exclusions or express limitations on the amount, duration, or scope of coverage; or "(ii) a decision regarding eligibility for any benefits. "(3) EXHAUSTION OF INTERNAL REVIEW PROCESS.-Except as provided under section 2802(d), a plan or issuer may condition the use of an external appeal process in the case of an externally appealable decision upon a final decision in an internal review under section 2802, but only if the decision is made in a timely basis consistent with the deadlines provided under this subtitle. "(4) FILING FEE REQUIREMENT.— "(A) IN GENERAL.-A plan or issuer may condition the use of an external appeal process upon payment in advance to the plan or issuer of a $25 filing fee. “(B) REFUNDING FEE IN CASE OF SUCCESSFUL APPEALS. The plan or issuer shall refund payment of the filing fee under this paragraph if the recommendation of the external appeal entity is to reverse the denial of a claim for benefits which is the subject of the appeal. "(b) GENERAL ELEMENTS OF EXTERNAL APPEALS PROCESS. "(1) USE OF QUALIFIED EXTERNAL APPEAL ENTITY. “(A) IN GENERAL.-The external appeal process under this section of a plan or issuer shall be conducted between the plan or issuer and one or more qualified external appeal entities (as defined in subsection (c)). Nothing in this subsection shall be construed as requiring that such procedures provide for the selection for any plan of more than one such entity. “(B) LIMITATION ON PLAN OR ISSUER SELECTION. The Secretary shall implement procedures to assure that the selection process among qualified external appeal entities will not create any incentives for external appeal entities to make a decision in a biased manner. "(C) OTHER TERMS AND CONDITIONS.-The terms and conditions of this paragraph shall be consistent with the standards the Secretary shall establish to assure there is no real or apparent conflict of interest in the conduct of external appeal activities. All costs of the process (except those incurred by the participant, beneficiary, enrollee, or treating professional in support of the appeal) shall be paid by the plan or issuer, and not by the participant, beneficiary, or enrollee. The previous sentence shall not be construed as applying to the imposition of a filing fee under subsection (a)(4). "(2) ELEMENTS OF PROCESS.-An external appeal process shall be conducted consistent with standards established by the Secretary that include at least the following: "(A) FAIR AND DE NOVO DETERMINATION.— The process shall provide for a fair, de novo determination described in subparagraph (B) based on evidence described in subparagraphs (C) and (D). "(B) STANDARD OF REVIEW.-An external appeal entity shall determine whether the plan's or issuer's decision is appropriate for the medical condition of the patient involved (as determined by the entity) taking into account as of the time of the entity's determination the patient's medical condition and any relevant and reliable evidence the entity obtains under subparagraphs (C) and (D). If the entity determines the decision is appropriate for such condition, the entity shall affirm the decision and to the extent that the entity determines the decision is not appropriate for such condition, the entity shall reverse the decision. Nothing in this subparagraph shall be construed as providing for coverage of items or services not provided or covered by the plan or issuer. "(C) REQUIRED CONSIDERATION OF CERTAIN MATTERS.-In making such determination, the external appeal entity shall consider, but not be bound by "(i) any language in the plan or coverage document relating to the definitions of the terms medical necessity, medically necessary or appropriate, or experimental, investigational, or related terms; "(ii) the decision made by the plan or issuer upon internal review under section 2802 and any guidelines or standards used by the plan or issuer in reaching such decision; and “(iii) the opinion of the individual's treating physician or health care professional. The entity also shall consider any personal health and medical information supplied with respect to the individual whose denial of claim for benefits has been appealed. The entity also shall consider the results of studies meet professionally recognized standards of validity and replicability or that have been published in peer-reviewed journals. "(D) ADDITIONAL EVIDENCE.-Such entity may also take into consideration but not be limited to the following evidence (to the extent available): "(i) The results of professional consensus conferences. “(ii) Practice and treatment policies. "(iii) Community standard of care. "(iv) Generally accepted principles of professional medical practice consistent with the best practice of medicine. "(v) To the extent that the entity determines it to be free of any conflict of interest, the opinions of individuals who are qualified as experts in one or more fields of health care which are directly related to the matters under appeal. "(vi) To the extent that the entity determines it to be free of any conflict of interest, the results of peer reviews conducted by the plan or issuer involved. "(E) DETERMINATION CONCERNING EXTERNALLY APPEALABLE DECISIONS. "(i) IN GENERAL.-A qualified external appeal entity shall determine "(I) whether a denial of claim for benefits is an externally appealable decision (within the meaning of subsection (a)(2)); "(II) whether an externally appealable decision involves an expedited appeal; "(III) for purposes of initiating an external review, whether the internal review process has been completed; and "(IV) whether the item or services is covered under the plan or coverage. "(ii) CONSTRUCTION.-Nothing in a determination by a qualified external appeal entity under this section shall be construed as authorizing, or providing for, coverage of items and services for which benefits are not provided under the plan or coverage. "(F) OPPORTUNITY TO SUBMIT EVIDENCE.— Each party to an externally appealable deci sion may submit evidence related to the issues in dispute. "(G) PROVISION OF INFORMATION.-The plan or issuer involved shall provide to the external appeal entity timely access to information and to provisions of the plan or health insurance coverage relating to the matter of the externally appealable decision, as determined by the entity. The provider involved shall provide to the external appeal entity timely access to information relevant to the matter of the externally appealable decision, as determined by the entity. "(H) TIMELY DECISIONS.-A determination by the external appeal entity on the decision shall "(i) be made orally or in written or electronic form and, if it is made orally, shall be supplied to the parties in written or electronic form as soon as possible; "(ii) be made in accordance with the medical exigencies of the case involved, but in no event later than 21 days after the date (or, in the case of an expedited appeal, 48 hours after the time) of requesting an external appeal of the decision: "(iii) state, in layperson's language, the scientific rationale for such determination as well as the basis for such determination, including, if relevant, any basis in the terms or conditions of the plan or coverage; and “(iv) inform the participant, beneficiary, or enrollee of the individual's rights (including any limitation on such rights) to seek binding arbitration or further review by the courts (or other process) of the external appeal determination. "(I) COMPLIANCE WITH DETERMINATION.—If the external appeal entity determines that a denial of a claim for benefits was not reasonable and reverses the denial, the plan or issuer "(i) shall (upon the receipt of the determination) authorize the provision or payment for benefits in accordance with such determination; "(ii) shall take such actions as may be necessary to provide or pay for benefits (including items or services) in a timely manner consistent with such determination; and "(iii) shall submit information to the entity documenting compliance with the entity's determination and this subparagraph. "(J) CONSTRUCTION.-Nothing in this paragraph shall be construed as providing for coverage of items and services for which benefits are not provided under the plan or coverage. "(c) QUALIFICATIONS OF EXTERNAL APPEAL ENTITIES. “(1) IN GENERAL.-For purposes of this section, the term 'qualified external appeal entity' means, in relation to a plan or issuer, an entity that is certified under paragraph (2) as meeting the following requirements: "(A) The entity meets the independence requirements of paragraph (3). "(B) The entity conducts external appeal activities through at least three clinical peers who are practicing physicians. "(C) The entity has sufficient medical, legal, and other expertise and sufficient staffing to conduct external appeal activities for the plan or issuer on a timely basis consistent with subsection (b)(2)(G). "(2) INITIAL CERTIFICATION OF EXTERNAL APPEAL ENTITIES. "(A) IN GENERAL.-In order to be treated as a qualified external appeal entity with respect to a group health plan or health insurance issuer operating in a State, the entity must be certified (and, in accordance with subparagraph (B), periodically recertified) as meeting such requirements "(i) by the applicable State authority (or under a process recognized or approved by such authority); or "(ii) if the State has not established a certification and recertification process for such entities, by the Secretary, under a process recognized or approved by the Secretary, or to the extent provided in subparagraph (C)(ii), by a qualified private standard-setting organization (certified under such subparagraph), if elected by the entity. "(B) RECERTIFICATION PROCESS.-The Secretary shall develop standards for the recertification of external appeal entities. Such standards shall include a review of— "(i) the number of cases reviewed; "(ii) a summary of the disposition of those cases; "(iii) the length of time in making determinations on those cases; "(iv) updated information of what was required to be submitted as a condition of certification for the entity's performance of external appeal activities; and "(v) information necessary to assure that the entity meets the independence requirements (described in paragraph (3)) with respect to plans and issuers for which it conducts external review activities. "(C) CERTIFICATION OF QUALIFIED PRIVATE STANDARD-SETTING ORGANIZATIONS.-For purposes of subparagraph (A)(ii), the Secretary may provide for a process for certification (and periodic recertification) of qualified private standard-setting organizations which provide for certification of external appeal entities. Such an organization shall only be certified if the organization does not certify an external appeal entity unless it meets standards as least as stringent as the standards required for certification of such an entity by the Secretary under subparagraph (A)(ii). "(3) INDEPENDENCE REQUIREMENTS. "(A) IN GENERAL.-A clinical peer or other entity meets the independence requirements of this paragraph if— "(i) the peer or entity is not affiliated with any related party; "(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) the plan and the issuer (if any) 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. "(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; or "(iv) the manufacturer of any drug or other item that was included in the health care involved in the coverage decision. "(C) AFFILIATED.-For purposes of this paragraph, the term 'affiliated' means, in connection with any peer or entity, having a familial, financial, or fiduciary relationship with such peer or entity. "(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, "(1) IN GENERAL.-The determination by an external appeal entity shall be binding on the plan (and issuer, if any) involved in the determination. "(2) PROTECTION OF LEGAL RIGHTS.-Nothing in this subtitle shall be construed as removing any legal rights of participants, beneficiaries, enrollees, and others under State or Federal law, including the right to file judicial actions to enforce rights. "(e) PENALTIES AGAINST AUTHORIZED OFFICIALS FOR REFUSING TO AUTHORIZE THE DETERMINATION OF AN EXTERNAL APPEAL ENTI TY. "(1) MONETARY PENALTIES.-In any case in which the determination of an external appeal entity is not followed in a timely fashion by a group health plan, or by a health insurance issuer offering health insurance coverage, any named fiduciary 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 appeal 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 resulting 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. "(f) PROTECTION OF LEGAL RIGHTS.-Nothing in this subtitle shall be construed as removing or limiting any legal rights of participants, beneficiaries, enrollees, and others under State or Federal law (including section 502 of the Employee Retirement Income Security Act of 1974), including the right to file judicial actions to enforce rights. "SEC. 2804. 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. "(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 beginning two months after the date of the enactment of this Act, all grievances and appeals made and their status. "(3) A process providing processing and resolution of grievances within 60 days. "(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. 2811. 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 health insurance issuer. "(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. may "(c) OPEN SEASON. An enrollee 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. 2812. CHOICE OF HEALTH CARE PROFESSIONAL. "(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.-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. "SEC. 2813. 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 or covers 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 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.—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 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; 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 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). "(c) COVERAGE OF EMERGENCY AMBULANCE SERVICES. "(1) IN GENERAL.-If a group health plan, or health insurance coverage provided by a health insurance issuer, provides any benefits with respect to ambulance services and emergency services, the plan or issuer shall cover emergency ambulance services (as defined in paragraph (2))) furnished under the plan or coverage under the same terms and conditions under subparagraphs (A) through (D) of subsection (a)(1) under which coverage is provided for emergency services. "(2) EMERGENCY AMBULANCE SERVICES.-For purposes of this subsection, the term 'emergency ambulance services' means ambulance services (as defined for purposes of section 1861(s)(7) of the Social Security Act) furnished to transport an individual who has an emergency medical condition (as defined in subsection (a)(2)(A)) to a hospital for the receipt of emergency services (as defined in subsection (a)(2)(B)) in a case in which the emergency services are covered under the plan or coverage pursuant to subsection (a)(1) and a prudent layperson, with an average knowledge of health and medicine, could reasonably expect that the absence of such transport would result in placing the health of the individual in serious jeopardy, serious impairment of bodily function, or serious dysfunction of any bodily organ or part. "SEC. 2814. 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 or the individual requires physician pathology services, and "(C) benefits for such treatment or services 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 (consistent with standards developed under section 2818) 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. |