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the request, of the need for such specified ad “(A) the reasons for the denial (including plan or issuer shall, in accordance with the ditional information, and the clinical rationale);

medical exigencies of the case but not later “(IV) requires the requester to submit “(B) instructions on how to initiate an ap than the deadline specified in subparagraph specified information not later than 2 busi peal under section 802; and

(B), complete the review on the denial and ness days after notification,

“(C) notice of the availability, upon re transmit to the participant, beneficiary, or the deadline specified in this subparagraph is quest of the individual (or the individual's other person involved a decision that af14 days after the date the program receives

designee) of the clinical review criteria re firms, reverses, or modifies the denial. If the the specified additional information, but in lied upon to make such denial.

decision does not reverse the denial, the plan no case later than 28 days after the date of “(2) SPECIFICATION OF ANY ADDITIONAL IN or issuer shall transmit, in printed or elecreceipt of the request for the prior authoriza FORMATION.-Such a notice shall also specify tronic form, a notice that sets forth the tion. This clause shall not apply if the dead what (if any) additional necessary informa grounds for such decision and that includes a line is specified in clause (iii).

tion must be provided to, or obtained by, the description of rights to any further appeal. “(iii) EXPEDITED CASES.-In the case of a person making the denial in order to make a Such decision shall be treated as the final situation described in section 802(C)(1)(A), decision on such an appeal.

decision of the plan. Failure to issue such a the deadline specified in this subparagraph is “(f) CLAIM FOR BENEFITS AND DENIAL OF

decision by such deadline shall be treated as 48 hours after the time of the request for CLAIM FOR BENEFITS DEFINED.—For purposes a final decision affirming the denial of claim. prior authorization. of this subpart:

“(B) DEADLINE.“(2) ONGOING CARE.— “(1) CLAIM FOR BENEFITS.—The term 'claim

"(i) IN GENERAL.-Subject to clauses (ii) “(A) CONCURRENT REVIEW.— for benefits' means any request for coverage

and (iii), the deadline specified in this sub"(i) IN GENERAL.-Subject to subparagraph (including authorization of coverage), or for

paragraph is 14 days after the earliest date (B), in the case of a concurrent review of on payment in whole or in part, for an item or

as of which the request for prior authorizagoing care (including hospitalization), which service under a group health plan or health

tion has been received and all necessary inresults in a termination or reduction of such insurance coverage offered in connection

formation has been provided. The provider care, the plan must provide by telephone and with such a plan.

involved shall provide timely access to inforin printed or electronic form notice of the “(2) DENIAL OF CLAIM FOR BENEFITS.-The

mation relevant to the matter of the review

decision. concurrent review determination to the indi term 'denial' means, with respect to a claim vidual or the individual's designee and the for benefits, a denial, or a failure to act on

“(ii) EXTENSION PERMITTED WHERE NOTICE individual's health care provider as soon as a timely basis upon, in whole or in part, the

OF ADDITIONAL INFORMATION REQUIRED.-If a possible in accordance with the medical ex claim for benefits and includes a failure to

group health plan or health insurance

issuerigencies of the case, with sufficient time provide or pay for benefits (including items prior to the termination or reduction to and services) required to be provided or paid

"(I) receives a request for internal review, allow for an appeal under section 802(C)(1)(A) for under this part.

“(II) determines that additional informato be completed before the termination or

tion is necessary to complete the review and “SEC. 802. INTERNAL APPEALS PROCEDURES. reduction takes effect.

make the determination on the request,

“(a) RIGHT OF REVIEW.“(ii) CONTENTS OF NOTICE.-Such notice

“(III) notifies the requester, not later than

“(1) IN GENERAL.-Each group health plan, shall include, with respect to ongoing health

5 business days after the date of receiving and each health insurance issuer offering care items and services, the number of ongo

the request, of the need for such specified adhealth insurance coverage in connection ing services approved, the new total of ap

ditional information, and with such a planproved services, the date of onset of services,

“(IV) requires the requester to submit

“(A) shall provide adequate notice in writand the next review date, if any, as well as a

specified information not later than 48 hours ten or electronic form to any participant or statement of the individual's rights to fur

after notification, beneficiary under such plan whose claim for ther appeal.

the deadline specified in this subparagraph is benefits under the plan or coverage has been “(B) EXCEPTION.–Subparagraph (A) shall

14 days after the date the plan or issuer redenied (within the meaning of section not be interpreted as requiring plans or

ceives the specified additional information, 801(f)(2)), setting forth the specific reasons issuers to provide coverage of care that

but in no case later than 28 days after the for such denial of claim for benefits and would exceed the coverage limitations for

date of receipt of the request for the internal rights to any further review or appeal, writsuch care.

review. This clause shall not apply if the ten in layman's terms to be understood by “(3) PREVIOUSLY PROVIDED SERVICES.-In

deadline is specified in clause (iii). the participant or beneficiary; and the case of a utilization review activity in

“(iii) EXPEDITED CASES.-In the case of a

"(B) shall afford such a participant or benvolving retrospective review of health care

situation described in subsection (c)(1)(A), eficiary (and any provider or other person services previously provided for an indi

the deadline specified in this subparagraph is acting on behalf of such an individual with vidual, the utilization review program shall

48 hours after the time of request for review. make a determination concerning such serv

the individual's consent or without such con “(c) EXPEDITED REVIEW PROCESS.

sent if the individual is medically unable to ices, and provide notice of the determination

“(1) IN GENERAL.-A group health plan, and to the individual or the individual's designee

provide such consent) who is dissatisfied a health insurance issuer, shall establish and the individual's health care provider by

with such a denial of claim for benefits a rea procedures in writing for the expedited contelephone and in printed or electronic form,

sonable opportunity of not less than 180 days sideration of requests for review under subwithin 30 days of the date of receipt of infor

to request and obtain a full and fair review section (b) in situationsmation that is reasonably necessary to make

by a named fiduciary (with respect to such (A) in which, as determined by the plan or such determination, but in no case later

plan) or named appropriate individual (with issuer or as certified in writing by a treating than 60 days after the date of receipt of the

respect to such coverage) of the decision de physician, the application of the normal claim for benefits. nying the claim.

timeframe for making the determination “(4) FAILURE TO MEET DEADLINE.—In a case

“(2) TREATMENT OF ORAL REQUESTS.—The could seriously jeopardize the life or health in which a group health plan or health insur

request for review under paragraph (1)(B) of the participant or beneficiary or such inance issuer fails to make a determination on

may be made orally, but, in the case of an dividual's ability to regain maximum funca claim for benefit under paragraph (1),

oral request, shall be followed by a request tion; or (2)(A), or (3) by the applicable deadline estabin written or electronic form.

"(B) described in section 801(d)(2) (relating lished under the respective paragraph, the

“(b) INTERNAL REVIEW PROCESS.

to requests for continuation of ongoing care failure shall be treated under this subpart as

“(1) CONDUCT OF REVIEW.

which would otherwise be reduced or termia denial of the claim as of the date of the

“(A) IN GENERAL.-A review of a denial of nated). deadline.

claim under this section shall be made by an "(2) PROCESS.-Under such procedures“(5) REFERENCE TO SPECIAL RULES FOR

individual (who shall be a physician in a case “(A) the request for expedited review may EMERGENCY SERVICES, MAINTENANCE CARE,

involving medical judgment) who has been be submitted orally or in writing by an indiPOST-STABILIZATION CARE, AND EMERGENCY

selected by the plan or issuer and who did vidual or provider who is otherwise entitled AMBULANCE SERVICES.-For waiver of prior

not make the initial denial in the internally to request the review; authorization requirements in certain cases

appealable decision, except that in the case "(B) all necessary information, including involving emergency services, maintenance of limited scope coverage (as defined in sub the plan's or issuer's decision, shall be transcare and post-stabilization care, and emer paragraph (B)) an appropriate specialist mitted between the plan or issuer and the regency ambulance services, see subsections shall review the decision.

quester by telephone, facsimile, or other (a)(1), (b), and (c)(1) of section 813, respec “(B) LIMITED SCOPE COVERAGE DEFINED. similarly expeditious available method; and tively.

For purposes of subparagraph (A), the term “(C) the plan or issuer shall expedite the “(e) NOTICE OF DENIALS OF CLAIMS FOR BEN ‘limited scope coverage' means group review in the case of any of the situations EFITS.

health plan or health insurance coverage the described in subparagraph (A) or (B) of para“(1) IN GENERAL.-Notice of a denial of only benefits under which are for benefits de graph (1). claims for benefits under a utilization review scribed in section 2791(c)(2)(A) of the Public “(3) DEADLINE FOR DECISION.-The decision program shall be provided in printed or elec Health Service Act (42 U.S.C. 300gg-91(C)(2)). on the expedited review must be made and tronic form and written in a manner cal “(2) TIME LIMITS FOR INTERNAL REVIEWS. communicated to the parties as soon as OSculated to be understood by the participant “(A) IN GENERAL.-Having received such a sible in accordance with the medical exigenor beneficiary and shall include

request for review of a denial of claim, the cies of the case, and in no event later than 48

a

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 or beneficiary 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, designee, or provider, proceed directly to seek further appeal through any applicable external appeals process. "SEC. 803. EXTERNAL APPEALS PROCEDURES.

“(a) RIGHT TO EXTERNAL APPEAL.

“(1) IN GENERAL.-A group health plan, and a health insurance issuer offering health insurance coverage in connection with such a plan, 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 or beneficiary (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 801(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 802 or such standards as are established pursuant to section 818.

“(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

provided under section 802(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 802, but only if the decision is made in a timely basis consistent with the deadlines provided under this subpart.

“(4) FILING FEE REQUIREMENT.

“(A) IN GENERAL.-A plan or issuer may condition the use of an external appeal proc

ess 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, or treating professional in support of the appeal) shall be paid by the plan or issuer, and not by the participant or beneficiary. 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 802 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 that 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 decision 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 or beneficiary 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 reason

able and reverses the denial, the plan or subparagraph to any person outside the De external appeal entity until the date the reissuerpartment of Labor.

fusal to provide the benefit is corrected. “(i) shall (upon the receipt of the deter “(3) INDEPENDENCE REQUIREMENTS.

“(2) CEASE AND DESIST ORDER AND ORDER OF mination) authorize benefits in accordance “(A) IN GENERAL.-A clinical peer or other ATTORNEY'S FEES.-In any action described in with such determination;

entity meets the independence requirements paragraph (1) brought by a participant or “(ii) shall take such actions as may be nec of this paragraph if

beneficiary with respect to a group health essary to provide benefits (including items

“(i) the peer or entity is not affiliated with plan, or a health insurance issuer offering or services) in a timely manner consistent any related party;

health insurance coverage in connection with such determination; and

“(ii) any compensation received by such with such a plan, in which a plaintiff alleges “(iii) shall submit information to the enti peer or entity in connection with the exter that a person referred to in such paragraph ty documenting compliance with the entity's nal review is reasonable and not contingent has taken an action resulting in a refusal of determination and this subparagraph.

on any decision rendered by the peer or enti a benefit determined by an external appeal “(J) CONSTRUCTION.-Nothing in this para ty:

entity in violation of such terms of the plan, graph shall be construed as providing for “(iii) the plan and the issuer (if any) have coverage, or this subpart, or has failed to coverage of items and services for which ben

no recourse against the peer or entity in con take an action for which such person is reefits are not provided under the plan or cov nection with the external review; and

sponsible under the plan, coverage, or this erage.

“(iv) the peer or entity does not otherwise part and which is necessary under the plan "(c) QUALIFICATIONS OF EXTERNAL APPEAL

have a conflict of interest with a related or coverage for authorizing a benefit, the ENTITIES.party.

court shall cause to be served on the defend“(1) IN GENERAL.–For purposes of this sec

“(B) RELATED PARTY.-For purposes of this ant an order requiring the defendant, tion, the term 'qualified external appeal en

paragraph, the term 'related party' means “(A) to cease and desist from the alleged tity' means, in relation to a plan or issuer,

“(i) a group health plan or health insur action or failure to act; and an entity that is certified under paragraph

ance coverage offered in connection with “(B) to pay to the plaintiff a reasonable at(2) as meeting the following requirements:

such a plan, the plan or the health insurance torney's fee and other reasonable costs relat"(A) The entity meets the independence re

issuer offering such coverage, or any plan ing to the prosecution of the action on the quirements of paragraph (3).

sponsor, fiduciary, officer, director, or man charges on which the plaintiff prevails. “(B) The entity conducts external appeal agement employee of such plan or issuer;

“(f) PROTECTION OF LEGAL RIGHTS.—Nothactivities through at least three clinical

“(ii) the health care professional that pro ing in this subpart shall be construed as repeers who are practicing physicians.

vided the health care involved in the cov moving or limiting any legal rights of par“(C) The entity has sufficient medical,

erage decision; legal, and other expertise and sufficient

ticipants, beneficiaries, and others under

“(iii) the institution at which the health State or Federal law (including section 502), staffing to conduct external appeal activities

care involved in the coverage decision is pro including the right to file judicial actions to for the plan or issuer on a timely basis convided; or

enforce rights. sistent with subsection (b)(2)(G).

“(iv) the manufacturer of any drug or “SEC. 804. ESTABLISHMENT OF A GRIEVANCE “(2) INITIAL CERTIFICATION OF EXTERNAL APother item that was included in the health

PROCESS. PEAL ENTITIES.“(A) IN GENERAL.-In order to be treated as care involved in the coverage decision.

“(a) ESTABLISHMENT OF GRIEVANCE SYS

“(C) AFFILIATED.-For purposes of this TEM.a qualified external appeal entity with re

paragraph, the term “affiliated' means, in “(1) IN GENERAL.-A group health plan, and spect to a group health plan or a health inconnection with any peer or entity, having a

a health insurance issuer in connection with surance issuer in connection with a group health plan, the entity must be certified

familial, financial, or fiduciary relationship the provision of health insurance coverage in (and, in accordance with subparagraph (B), with such peer or entity.

connection with such a plan, shall establish

“(4) LIMITATION ON LIABILITY OF REVIEWperiodically recertified), under such stand

and maintain a system to provide for the ards as may be prescribed by the Secretary, ERS.-No qualified external appeal entity

presentation and resolution of oral and writhaving a contract with a plan or issuer under as meeting the requirements of paragraph

ten grievances brought by individuals who (1)

this part and no person who is employed by are participants or beneficiaries or health

any such entity or who furnishes profes care providers or other individuals acting on "(i) by the Secretary; "(ii) under a process recognized or ap

sional services to such entity, shall be held behalf of an individual and with the individby reason of the performance of any duty,

ual's consent or without such consent if the proved by the Secretary; or “(iii) to the extent provided in subpara

function, or activity required or authorized individual is medically unable to provide graph (C)(i), by a qualified private standard

pursuant to this section, to have violated such consent, regarding any aspect of the setting organization (certified under such

any criminal law, or to be civilly liable plan's or issuer's services. subparagraph), if elected by the entity. under any law of the United States or of any

“(2) GRIEVANCE DEFINED.-In this section, “(B) RECERTIFICATION PROCESS.—The SecState (or political subdivision thereof) if due

the term 'grievance' means any question, retary shall develop standards for the recer

was exercised in the performance of complaint, or concern brought by a particitification of external appeal entities. Such such duty, function, or activity and there pant or beneficiary that is not a claim for

benefits. standards shall include a review of—

was no actual malice or gross misconduct in “(i) the number of cases reviewed;

“(b) GRIEVANCE SYSTEM.-Such system the performance of such duty, function, or "(ii) a summary of the disposition of those activity.

shall include the following components with cases;

“(d) EXTERNAL APPEAL DETERMINATION

respect to individuals who are participants "(iii) the length of time in making deter BINDING ON PLAN.

or beneficiaries: minations on those cases;

“(1) IN GENERAL.-The determination by an

“(1) Written notification to all such indi“(iv) updated information of what was re external appeal entity shall be binding on

viduals and providers of the telephone numquired to be submitted as a condition of cer the plan (and issuer, if any) involved in the

bers and business addresses of the plan or tification for the entity's performance of exdetermination.

issuer personnel responsible for resolution of ternal appeal activities; and

“(2) PROTECTION OF LEGAL RIGHTS.—Noth

grievances and appeals. “(v) information necessary to assure that ing in this subpart shall be construed as re

(2) A system to record and document, the entity meets the independence require moving any legal rights of participants,

over a period of at least 3 previous years bements (described in paragraph (3)) with re beneficiaries, and others under State or Fed

ginning two months after the date of the enspect to plans and issuers for which it con eral law, including the right to file judicial

actment of this Act, all grievances and apducts external review activities. actions to enforce rights.

peals made and their status. “(C) CERTIFICATION OF QUALIFIED PRIVATE “(e) PENALTIES AGAINST AUTHORIZED OFFI

*(3) A process providing processing and STANDARD-SETTING ORGANIZATIONS.—For pur CIALS FOR REFUSING TO AUTHORIZE THE DE

resolution of grievances within 60 days. poses of subparagraph (A)(iii), the Secretary TERMINATION OF AN EXTERNAL APPEAL ENTI

"(4) Procedures for follow-up action, inshall provide for a process for certification

cluding the methods to inform the person TY.(and periodic recertification of qualified pri “(1) MONETARY PENALTIES.-In any case in

making the grievance of the resolution of vate standard-setting organizations which which the determination of an external ap

the grievance. provide for certification of external appeal peal entity is not followed in a timely fash

Grievances are not subject to appeal under entities. Such an organization shall only be ion by a group health plan, or by a health in

the previous provisions of this subpart. certified if the organization does not certify surance issuer offering health insurance cov

“SUBPART B-ACCESS TO CARE an external appeal entity unless it meets erage in connection with such a plan, any "SEC. 812. CHOICE OF HEALTH CARE PROFESstandards at least as stringent as the stand named fiduciary who, acting in the capacity

SIONAL. ards required for certification of such an en of authorizing the benefit, causes such re “(a) PRIMARY CARE.—If a group health tity by the Secretary under subparagraph fusal may, in the discretion in a court of plan, or a health insurance issuer that offers (A)(i).

competent jurisdiction, be liable to an ag health insurance coverage in connection “(D) CONSTRUCTION.-Nothing in subpara grieved participant or beneficiary for a civil with such a plan, requires or provides for graph (A) shall be construed as permitting penalty in an amount of up to $1,000 a day designation by a participant or beneficiary the Secretary to delegate certification or from the date on which the determination of a participating primary care provider, regulatory authority under clause (i) of such was transmitted to the plan or issuer by the then the plan or issuer shall permit each par

care

ticipant and beneficiary 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 in connection with such a plan shall permit each participant or beneficiary to receive medically necessary or appropriate specialty care, pursuant to appropriate referral procedures, from any qualified participating health care professional who is available to accept such individual for such care. “SEC. 813. 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 in connection with such a plan, provides or covers any benefits with respect to services in an emergency department of a hospital, the plan or issuer

hall cover emergency services (as defined in paragraph (2)(B)—

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

“(B) whether the health care provider furnishing such services is a participating provider with respect to such services;

(C) in a manner so that, if such services are provided to a participant or beneficiary

“(i) by a nonparticipating health care provider with or without prior authorization, or

“(ii) by a participating health care provider without prior authorization, the participant or beneficiary is not liable for amounts that exceed the amounts of liability that would be incurred if the services were provided by a participating health care provider with prior authorization; and

“(D) without regard to any other term or condition of such coverage (other than exclusion or coordination of benefits, or an affiliation or waiting period, permitted under section 2701 of the Public Health Service Act, section 701, 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 term 'emergency services' means

“(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 in connection with such a plan, 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 or beneficiary other than through a participating health care provider in a

manner consistent with subsection (a)(1)(C) (and shall otherwise comply with such guidelines).

“(C) COVERAGE OF EMERGENCY AMBULANCE SERVICES.

“(1) IN GENERAL.-If a group health plan, or health insurance coverage provided by a health insurance issuer in connection with such a plan, 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. 814. ACCESS TO SPECIALTY CARE.

“(a) SPECIALTY CARE FOR COVERED SERVICES.

“(1) IN GENERAL.-1f

"(A) an individual is a participant or beneficiary under a group health plan or is covered under health insurance coverage offered by a health insurance issuer in connection with such a plan,

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

“(C) benefits for such treatment or services are provided under the plan 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 818) to provide the treatment for such condition or disease or to provide such services.

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

or physician pathologist that has adequate expertise through appropriate training and experience (including, in the case of a child, appropriate pediatric expertise and in the case of a pregnant woman, appropriate obstetrical expertise) to provide high quality care in treating the condition or to provide physician pathology services.

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

“(A) pursuant to a treatment plan, only if the treatment plan is developed by the specialist and approved by the plan 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 a specialist that is available and accessible to treat the individual's condition or provide physician pathology services and that is a participating provider with respect to such treatment or services.

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

“(6) 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 in connection with such a plan, shall have a procedure by which an individual who is a participant or beneficiary and who has an ongoing special condition (as defined in paragraph (3)) may request and receive a referral to a specialist for such condition who shall be responsible for and capable of providing and coordinating the 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 coverage in connection with such a plan, re yond the period under paragraph (1) and disabling, and

quires or provides for a participant or bene until the date of discharge of the individual “(B) requires specialized medical care over ficiary to designate a participating primary after completion of the surgery or transplana prolonged period of time.

care provider for a child of such individual, tation. “(4) TERMS OF REFERRAL.-The provisions the plan or issuer shall permit the partici “(3) PREGNANCY.-Ifof paragraphs (3) through (5) of subsection (a) pant or beneficiary to designate a physician “(A) a participant or beneficiary was deterapply with respect to referrals under para (including a family practice physician) who mined to be pregnant at the time of a prograph (1) of this subsection in the same man specializes or is trained and experienced in vider's termination of participation, and ner as they apply to referrals under sub pediatrics as the child's primary care pro “(B) the provider was treating the pregsection (a)(1). vider.

nancy before date of the termination, “(5) CONSTRUCTION.-Nothing in this sub "(b) CONSTRUCTION.-Nothing in subsection

the transitional period under this subsection section shall be construed as preventing an (a) shall be construed to waive any exclu with respect to provider's treatment of the individual who is a participant or bene sions of coverage under the terms of the plan pregnancy shall extend through the provificiary and who has an ongoing special condi with respect to coverage of pediatric care. sion of post-partum care directly related to tion from having the individual's primary "SEC. 817. CONTINUITY OF CARE.

the delivery. care physician assume the responsibilities “(a) IN GENERAL.

“(4) TERMINAL ILLNESS.-Iffor providing and coordinating care de “(1) TERMINATION OF PROVIDER.-If a con “(A) a participant or beneficiary was deterscribed in paragraph (1).

tract between a group health plan, or a mined to be terminally ill (as determined "(c) STANDING REFERRALS.

health insurance issuer in connection with under section 1861(dd)(3)(A) of the Social Se“(1) IN GENERAL.-A group health plan, and

the provision of health insurance coverage in curity Act) at the time of a provider's termia health insurance issuer in connection with connection with such a plan, and a health nation of participation, and the provision of health insurance coverage in care provider is terminated (as defined in “(B) the provider was treating the terconnection with such a plan, shall have a paragraph (3)(B)), or benefits or coverage

minal illness before the date of termination, procedure by which an individual who is a provided by a health care provider are termi the transitional period under this subsection participant or beneficiary and who has a con nated because of a change in the terms of

shall extend for the remainder of the individdition that requires ongoing care from a spe provider participation in a group health ual's life for care directly related to the cialist may receive a standing referral to plan, and an individual who is a participant

treatment of the terminal illness or its medsuch specialist for treatment of such condior beneficiary in the plan or coverage is un

ical manifestations. tion. If the plan or issuer, or if the primary dergoing treatment from the provider for an

"(c) PERMISSIBLE TERMS AND CONDITIONS.care provider in consultation with the medongoing special condition (as defined in para

A group health plan or health insurance ical director of the plan or issuer and the graph (3)(A)) at the time of such termi

issuer may condition coverage of continued specialist (if any), determines that such a nation, the plan or issuer shall

treatment by a provider under subsection standing referral is appropriate, the plan or "(A) notify the individual on a timely basis

(a)(1)(B) upon the individual notifying the issuer shall make such a referral to such a of such termination and of the right to elect

plan of the election of continued coverage specialist if the individual so desires. continuation of coverage of treatment by the

and upon the provider agreeing to the fol“(2) TERMS OF REFERRAL.—The provisions

lowing terms and conditions: provider under this section; and of paragraphs (3) through (5) of subsection (a)

"(B) subject to subsection (c), permit the

"(1) The provider agrees to accept reimapply with respect to referrals under paraindividual to elect to continue to be covered

bursement from the plan or issuer and indigraph (1) of this subsection in the same man with respect to treatment by the provider of

vidual involved with respect to cost-sharner as they apply to referrals under sub

ing) at the rates applicable prior to the start such condition during a transitional period section (a)(1). (provided under subsection (b)).

of the transitional period as payment in full "SEC. 815. ACCESS TO OBSTETRICAL AND GYNE

(or, in the case described in subsection (a)(2), “(2) TREATMENT OF TERMINATION OF CONCOLOGICAL CARE.

at the rates applicable under the replaceTRACT WITH HEALTH INSURANCE ISSUER.—If a “(a) IN GENERAL.-If a group health plan, contract for the provision of health insur

ment plan or issuer after the date of the teror a health insurance issuer in connection

mination of the contract with the health inance coverage between a group health plan with the provision of health insurance cov

surance issuer) and not to impose cost-sharand a health insurance issuer is terminated erage in connection with such a plan, re

ing with respect to the individual in an and, as a result of such termination, covquires or provides for a participant or bene

amount that would exceed the cost-sharing erage of services of a health care provider is ficiary to designate a participating primary terminated with respect to an individual, the

that could have been imposed if the contract care health care professional, the plan or provisions of paragraph (1) (and the suc

referred to in subsection (a)(1) had not been

terminated. issuer

ceeding provisions of this section shall “(1) may not require authorization or a re

“(2) The provider agrees to adhere to the apply under the plan in the same manner as ferral by the individual's primary care

quality assurance standards of the plan or if there had been a contract between the plan health care professional or otherwise for cov

issuer responsible for payment under paraand the provider that had been terminated,

graph (1) and to provide to such plan or ered gynecological care (including preven but only with respect to benefits that are

issuer necessary medical information related tive women's health examinations) or for covered under the plan after the contract

to the care provided. covered pregnancy-related services provided termination.

“(3) The provider agrees otherwise to adby a participating physician (including a “(3) DEFINITIONS.—For purposes of this sec

here to such plan's or issuer's policies and family practice physician) who specializes or tion:

procedures, including procedures regarding is trained and experienced in gynecology or “(A) ONGOING SPECIAL CONDITION.-The

referrals and obtaining prior authorization obstetrics, respectively, to the extent such term 'ongoing special condition has the

and providing services pursuant to a treatcare is otherwise covered; and meaning given such term in section 814(b)(3),

ment plan (if any) approved by the plan or “(2) shall treat the ordering of other gyne and also includes pregnancy.

issuer. cological or obstetrical care by such a par “(B) TERMINATION.—The term 'terminated' “(d) CONSTRUCTION.-Nothing in this secticipating physician as the authorization of

includes, with respect to a contract, the ex tion shall be construed to require the covthe primary care health care professional piration or nonrenewal of the contract, but erage of benefits which would not have been with respect to such care under the plan or does not include a termination of the con covered if the provider involved remained a coverage.

tract by the plan or issuer for failure to meet participating provider. “(b) CONSTRUCTION.—Nothing in subsection applicable quality standards or for fraud. “SEC. 818. NETWORK ADEQUACY. (a) shall be construed to

“(b) TRANSITIONAL PERIOD.

“(a) REQUIREMENT.-A group health plan, “(1) waive any exclusions of coverage "(1) IN GENERAL.-Except as provided in and a health insurance issuer providing under the terms of the plan with respect to paragraphs (2) through (4), the transitional

health insurance coverage in connection coverage of gynecological or obstetrical

period under this subsection shall extend up with such a plan, shall meet such standards care;

to 90 days (as determined by the treating for network adequacy as are established by "(2) preclude the group health plan or health care professional) after the date of law pursuant to this section. health insurance issuer involved from requir the notice described in subsection (a)(1)(A) of “(b) DEVELOPMENT OF STANDARDS.ing that the gynecologist or obstetrician no the provider's termination.

“(1) ESTABLISHMENT OF PANEL.—There is tify the primary care health care profes

“(2) SCHEDULED SURGERY AND ORGAN TRANS established a panel to be known as the sional or the plan of treatment decisions; or PLANTATION.-If surgery or organ transplan Health Care Panel to Establish Network

“(3) prevent a plan or issuer from offering, tation was scheduled for an individual before Adequacy Standards (in this section referred in addition to physicians described in sub the date of the announcement of the termi to as the 'Panel'). section (a)(1), non-physician health care pro

nation of the provider status under sub “(2) DUTIES OF PANEL.—The Panel shall defessionals who are trained and experienced in section (a)(1)(A) or if the individual on such vise standards for group health plans and gynecology or obstetrics.

date was on an established waiting list or health insurance issuers that offer health in"SEC. 816. ACCESS TO PEDIATRIC CARE.

otherwise scheduled to have such surgery or surance coverage in connection with such a “(a) PEDIATRIC CARE.-If a group health transplantation, the transitional period plan to ensure thatplan, or a health insurance issuer in connec under this subsection with respect to the "(A) participants and beneficiaries have tion with the provision of health insurance surgery or transplantation shall extend be access to a sufficient number, mix, and dis

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