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"Sec. 819. Access to experimental or in
drugs. "Sec. 820. Coverage for individuals par
ticipating 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 commu
nications. "Sec. 832. Prohibition of discrimination
against providers based on li
censure. "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. 844. Coverage of limited scope
plans. “Sec. 845. Regulations. Sec. 203. Availability of court remedies. Sec. 204. Availability of binding arbitration.
TITLE III— AMENDMENTS TO THE
INTERNAL REVENUE CODE OF 1986
under the Internal Revenue
Code of 1986.
“CHAPTER 101-IMPROVING MANAGED CARE
“Sec. 9901. Utilization review activities.
sional. “Sec. 9913. Access to emergency care. “Sec. 9914. Access to specialty care. “Sec. 9915. Access to obstetrical and
gynecological care. “Sec. 9916. Access to pediatric care. “Sec. 9917. Continuity of care. "Sec. 9918. Network adequacy. “Sec. 9919. Access to experimental or in
drugs. “Sec. 9920. Coverage for individuals par
ticipating in approved cancer
clinical trials. “SUBCHAPTER C-ACCESS TO INFORMATION “Sec. 9921. Patient access to informa
tion. “SUBCHAPTER D-PROTECTING THE DOCTOR
PATIENT RELATIONSHIP “Sec. 9931. Prohibition of interference
with certain medical commu
nications. “Sec. 9932. Prohibition of discrimination
against providers based on li
censure. "Sec. 9933. Prohibition against improper
incentive arrangements. "Sec. 9934. Payment of clean claims.
"SUBCHAPTER E-DEFINITIONS “Sec. 9941. Definitions. “Sec. 9942. Exclusions. “Sec. 9943. Coverage of limited scope
TITLE IV-EFFECTIVE DATES;
TITLE V-OTHER PROVISIONS
Subtitle B-Other Matters
review' and 'utilization review activities' Sec. 511. Health care paperwork simplifica mean procedures used to monitor or evaluate tion.
the use or coverage, clinical necessity, ap
propriateness, efficacy, or efficiency of TITLE I- AMENDMENTS TO THE PUBLIC
health care services, procedures or settings, HEALTH SERVICE ACT
and includes prospective review, concurrent SEC. 101. APPLICATION TO GROUP HEALTH
review, second opinions, case management, PLANS AND GROUP HEALTH INSUR
discharge planning, or retrospective review. ANCE COVERAGE.
“(b) WRITTEN POLICIES AND CRITERIA.(a) IN GENERAL.-Subpart 2 of part A of “(1) WRITTEN POLICIES.-A utilization retitle XXVII of the Public Health Service Act
view program shall be conducted consistent is amended by adding at the end the fol
with written policies and procedures that lowing new section:
govern all aspects of the program. “SEC. 2707. PATIENT PROTECTION STANDARDS.
“(2) USE OF WRITTEN CRITERIA.“(a) IN GENERAL.-Each group health plan “(A) IN GENERAL.-Such a program shall shall comply with patient protection re utilize written clinical review criteria develquirements under title XXVIII, and each oped with input from a range of appropriate health insurance issuer shall comply with practicing physicians, as determined by the patient protection requirements under such plan, pursuant to the program. Such criteria title with respect to group health insurance shall include written clinical review criteria coverage it offers, and such requirements that are based on valid clinical evidence shall be deemed to be incorporated into this where available and that are directed specifisubsection.
cally at meeting the needs of at-risk popu“(b) NOTICE.-A group health plan shall lations and covered individuals with chronic comply with the notice requirement under conditions or severe illnesses, including gensection 711(d) of the Employee Retirement
der-specific criteria and pediatric-specific Income Security Act of 1974 (as in effect on
criteria where available and appropriate. the date of the enactment of the Health Care
“(B) CONTINUING USE OF STANDARDS IN RETQuality and Choice Act of 1999) with respect
ROSPECTIVE REVIEW. If a health care service to the requirements referred to in subsection has been specifically pre-authorized or ap(a) and a health insurance issuer shall com
proved for an enrollee under such a program, ply with such notice requirement as if such
the program shall not, pursuant to retrosection applied to such issuer and such issuer
spective review, revise or modify the specific were a group health plan.”.
standards, criteria, or procedures used for (b) CONFORMING AMENDMENT.-Section
the utilization review for procedures, treat2721(b)(2)(A) of such Act (42 U.S.C. 300gg
ment, and services delivered to the enrollee 21(b)(2)(A)) is amended by inserting "(other
during the same course of treatment. than section 2707)” after “requirements of
“(C) REVIEW OF SAMPLE OF CLAIMS DENIsuch subparts”.
ALS.-Such a program shall provide for peri
odic evaluation at reasonable intervals of SEC. 102. APPLICATION TO INDIVIDUAL HEALTH INSURANCE COVERAGE.
the clinical appropriateness of a sample of
denials of claims for benefits. Part B of title XXVII of the Public Health
"(c) CONDUCT OF PROGRAM ACTIVITIES.Service Act is amended by inserting after
“(1) ADMINISTRATION BY HEALTH CARE PROsection 2752 the following new section:
FESSIONALS.-A utilization review program “SEC. 2753. PATIENT PROTECTION STANDARDS. shall be administered by appropriate physi
“(a) IN GENERAL.-Each health insurance cian specialists who shall be selected by the issuer shall comply with patient protection plan or issuer and who shall oversee review requirements under title XXVIII with re decisions. spect to individual health insurance cov “(2) USE OF QUALIFIED, INDEPENDENT PERerage it offers, and such requirements shall SONNEL.be deemed to be incorporated into this sub “(A) IN GENERAL.-A utilization review prosection.
gram shall provide for the conduct of utiliza“(b) NOTICE.-A health insurance issuer tion review activities only through personnel under this part shall comply with the notice who are qualified and have received approrequirement under section 711(d) of the Em priate training in the conduct of such activiployee Retirement Income Security Act of ties under the program. 1974 with respect to the requirements of such “(B) PROHIBITION OF CONTINGENT COMPENSAtitle as if such section applied to such issuer TION ARRANGEMENTS.-Such a program shall and such issuer were a group health plan.”. not, with respect to utilization review activiSEC. 103. IMPROVING MANAGED CARE.
ties, permit or provide compensation or anyThe Public Health Service Act is amended thing of value to its employees, agents, or by adding at the end the following new title: contractors in a manner that encourages de"TITLE XXVIII-IMPROVING MANAGED
nials of claims for benefits. This subparaCARE
graph shall not preclude any capitation ar
rangements between plans and providers. "Subtitle A-Grievance and Appeals
“(C) PROHIBITION OF CONFLICTS.-Such a “SEC. 2801. UTILIZATION REVIEW ACTIVITIES. program shall not permit a health care pro
“(a) COMPLIANCE WITH REQUIREMENTS. fessional who is providing health care serv
“(1) IN GENERAL.-A group health plan, and ices to an individual to perform utilization a health insurance issuer that provides review activities in connection with the health insurance coverage, shall conduct uti health care services being provided to the inlization review activities in connection with dividual. the provision of benefits under such plan or “(3) ACCESSIBILITY OF REVIEW.-Such a procoverage only in accordance with a utiliza gram shall provide that appropriate pertion review program that meets the require sonnel performing utilization review activiments of this section.
ties under the program, including the utili“(2) USE OF OUTSIDE AGENTS.-Nothing in zation review administrator, are reasonably this section shall be construed as preventing accessible by toll-free telephone during nora group health plan or health insurance mal business hours to discuss patient care issuer from arranging through a contract or and allow response to telephone requests, otherwise for persons or entities to conduct and that appropriate provision is made to reutilization review activities on behalf of the ceive and respond promptly to calls received plan or issuer, so long as such activities are during other hours. conducted in accordance with a utilization “(4) LIMITS ON FREQUENCY.-Such a proreview program that meets the requirements gram shall not provide for the performance of this section.
of utilization review activities with respect “(3) UTILIZATION REVIEW DEFINED.-For pur to a class of services furnished to an indiposes of this section, the terms ‘utilization vidual 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.
“(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.
"(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
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 suer nd 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.
“(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 September of the preceding calendar year based on evidence described in subparagraphs 48 hours after the time of request for review has increased or decreased from such index (C) and (D). "(c) EXPEDITED REVIEW PROCESS.for September 2000, and
“(B) STANDARD OF REVIEW.-An external “(1) IN GENERAL.-A group health plan, and "(iii) the requirements of subparagraph (B) appeal entity shall determine whether the a health insurance issuer, shall establish are met with respect to such denial.
plan's or issuer's decision is appropriate for procedures in writing for the expedited con Such term also includes a failure to meet an the medical condition of the patient involved sideration of requests for review under sub applicable deadline for internal review under (as determined by the entity) taking into acsection (b) in situations
section 2802 or such standards as are estab count as of the time of the entity's deter"(A) in which, as determined by the plan or lished pursuant to section 2818.
mination the patient's medical condition issuer or as certified in writing by a treating “(B) REQUIREMENTS.–For purposes of sub and any relevant and reliable evidence the physician, the application of the normal paragraph (A)(iii), the requirements of this entity obtains under subparagraphs (C) and timeframe for making the determination subparagraph are met with respect to a de (D). If the entity determines the decision is could seriously jeopardize the life or health nial of a claim for benefits if
appropriate for such condition, the entity of the participant, beneficiary, or enrollee or “(i) the denial is based in whole or in part shall affirm the decision and to the extent such individual's ability to regain maximum on a decision that the item or service is not that the entity determines the decision is function; or
medically necessary or appropriate or is in not appropriate for such condition, the enti“(B) described in section 2801(d)(2) (relat vestigational or experimental, or
ty shall reverse the decision. Nothing in this ing to requests for continuation of ongoing
“(ii) in such denial, the decision as to subparagraph shall be construed as providing care which would otherwise be reduced or
whether an item or service is covered in for coverage of items or services not proterminated). volves a medical judgment.
vided or covered by the plan or issuer. (2) PROCESS.-Under such procedures
“(C) EXCLUSIONS.—The term 'externally ap “(C) REQUIRED CONSIDERATION OF CERTAIN "(A) the request for expedited review may pealable decision' does not include
MATTERS.—In making such determination, be submitted orally or in writing by an indi
“(i) specific exclusions or express limita the external appeal entity shall consider, but vidual or provider who is otherwise entitled tions on the amount, duration, or scope of not be bound byto request the review; coverage; or
“(i) any language in the plan or coverage “(B) all necessary information, including
"(ii) a decision regarding eligibility for document relating to the definitions of the the plan's or issuer's decision, shall be transany benefits.
terms medical necessity, medically necmitted between the plan or issuer and the re
“(3) EXHAUSTION OF INTERNAL REVIEW PROC
essary or appropriate, or experimental, inquester by telephone, facsimile, or other ESS.-Except as provided under section
vestigational, or related terms; similarly expeditious available method; and
2802(d), a plan or issuer may condition the "(ii) the decision made by the plan or "(C) the plan or issuer shall expedite the use of an external appeal process in the case
issuer upon internal review under section review in the case of any of the situations of an externally appealable decision upon a
2802 and any guidelines or standards used by final decision in an internal review under described in subparagraph (A) or (B) of para
the plan or issuer in reaching such decision; graph (1). section 2802, but only if the decision is made
and “(3) DEADLINE FOR DECISION.—The decision in a timely basis consistent with the dead
“(iii) the opinion of the individual's treatlines provided under this subtitle. on the expedited review must be made and
ing physician or health care professional. communicated to the parties as soon as pos
“(4) FILING FEE REQUIREMENT.-
The entity also shall consider any personal sible in accordance with the medical exigencondition the use of an external appeal proc
health and medical information supplied cies of the case, and in no event later than 48 ess upon payment in advance to the plan or
with respect to the individual whose denial hours after the time of receipt of the request
of claim for benefits has been appealed. The issuer of a $25 filing fee. for expedited review, except that in a case
“(B) REFUNDING FEE IN CASE OF SUCCESSFUL
entity also shall consider the results of studdescribed in paragraph (1)(B), the decision
ies that APPEALS.—The plan or issuer shall refund
meet professionally recognized must be made before the end of the approved payment of the filing fee under this para
standards of validity and replicability or period of care. graph if the recommendation of the external
that have been published in peer-reviewed “(d) WAIVER OF PROCESS.-A plan or issuer appeal entity is to reverse the denial of a
journals. may waive its rights for an internal review claim for benefits which is the subject of the
“(D) ADDITIONAL EVIDENCE.-Such entity under subsection (b). In such case the particappeal.
may also take into consideration but not be ipant, beneficiary, or enrollee involved and
“(b) GENERAL ELEMENTS OF EXTERNAL AP limited to the following evidence (to the exany designee or provider involved) shall be PEALS PROCESS.
tent available): relieved of any obligation to complete the
“(1) USE OF QUALIFIED EXTERNAL APPEAL
“(i) The results of professional consensus review involved and may, at the option of ENTITY.
conferences. such participant, beneficiary, enrollee, des
“(A) IN GENERAL.-The external appeal
“(ii) Practice and treatment policies. ignee, or provider, proceed directly to seek
process under this section of a plan or issuer “(iii) Community standard of care. further appeal through any applicable exter
shall be conducted between the plan or issuer “(iv) Generally accepted principles of pronal appeals process.
and one or more qualified external appeal en fessional medical practice consistent with "SEC. 2803. EXTERNAL APPEALS PROCEDURES. tities (as defined in subsection (c)). Nothing the best practice of medicine. “(a) RIGHT TO EXTERNAL APPEAL.
in this subsection shall be construed as re “(v) To the extent that the entity deter“(1) IN GENERAL.-A group health plan, and quiring that such procedures provide for the mines it to be free of any conflict of interest, a health insurance issuer offering health in selection for any plan of more than one such the opinions of individuals who are qualified surance coverage, shall provide for an exter entity.
as experts in one or more fields of health nal appeals process that meets the require “(B) LIMITATION ON PLAN OR ISSUER SELEC care which are directly related to the matments of this section in the case of an exter TION.-The Secretary shall implement proce ters under appeal. nally appealable decision described in para dures to assure that the selection process “(vi) To the extent that the entity detergraph (2), for which a timely appeal is made among qualified external appeal entities will mines it to be free of any conflict of interest, (within a reasonable period not to exceed 365 not create any incentives for external appeal the results of peer reviews conducted by the days) either by the plan or issuer or by the entities to make a decision in a biased man plan or issuer involved. participant, beneficiary, or enrollee (and any ner.
“(E) DETERMINATION CONCERNING EXTERprovider or other person acting on behalf of “(C) OTHER TERMS AND CONDITIONS.—The NALLY APPEALABLE DECISIONS.such an individual with the individual's con terms and conditions of this paragraph shall “(i) IN GENERAL.-A qualified external apsent or without such consent if such an indi be consistent with the standards the Sec peal entity shall determinevidual is medically unable to provide such retary shall establish to assure there is no “(I) whether a denial of claim for benefits consent).
real or apparent conflict of interest in the is an externally appealable decision (within “(2) EXTERNALLY APPEALABLE DECISION DE conduct of external appeal activities. All the meaning of subsection (a)(2)); FINED.
costs of the process (except those incurred by “(II) whether an externally appealable de“(A) IN GENERAL.–For purposes of this sec the participant, beneficiary, enrollee, or cision involves an expedited appeal; tion, the term "externally appealable deci treating professional in support of the ap "(III) for purposes of initiating an external sion' means a denial of claim for benefits (as peal) shall be paid by the plan or issuer, and review, whether the internal review process defined in section 2801(f)(2)), if
not by the participant, beneficiary, or en has been completed; and “(i) the item or service involved is covered rollee. The previous sentence shall not be “(IV) whether the item or services is covunder the plan or coverage,
construed as applying to the imposition of a ered under the plan or coverage. “(ii) the amount involved exceeds $100, in filing fee under subsection (a)(4).
“(ii) CONSTRUCTION.-Nothing in a detercreased or decreased, for each calendar year “(2) ELEMENTS OF PROCESS.-An external mination by a qualified external appeal entithat ends after December 31, 2001, by the appeal process shall be conducted consistent ty under this section shall be construed as same percentage as the percentage by which with standards established by the Secretary authorizing, or providing for, coverage of the medical care expenditure category of the that include at least the following:
items and services for which benefits are not Consumer Price Index for All Urban Con “(A) FAIR AND DE NOVO DETERMINATION. provided under the plan or coverage. sumers (United States city average), pub The process shall provide for a fair, de novo “(F) OPPORTUNITY TO SUBMIT EVIDENCE.lished by the Bureau of Labor Statistics, for determination described in subparagraph (B) 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,
function, or activity required or authorized pursuant to this section, to have violated any criminal law, or to be civilly liable under any law of the United States or of any State (or political subdivision thereof) if due care was exercised in the performance of such duty, function, or activity and there was no actual malice or gross misconduct in the performance of such duty, function, or activity.
"(d) EXTERNAL APPEAL DETERMINATION BINDING ON PLAN.
“(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 ENTITY.
“(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 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 “SEC. 2813. ACCESS TO EMERGENCY CARE.
during the transfer of the individual from a medically unable to provide such consent, “(a) COVERAGE OF EMERGENCY SERVICES. facility. regarding any aspect of the plan's or issuer's “(1) IN GENERAL.-If a group health plan, or “(b) REIMBURSEMENT FOR MAINTENANCE services.
health insurance coverage offered by a CARE AND POST-STABILIZATION CARE.-If ben“(2) GRIEVANCE DEFINED.-In this section, health insurance issuer, provides or covers efits are available under a group health plan, the term 'grievance' means any question, any benefits with respect to services in an or under health insurance coverage offered complaint, or concern brought by a partici emergency department of a hospital, the by a health insurance issuer, with respect to pant, beneficiary, or enrollee that is not a plan or issuer shall cover emergency services maintenance care or post-stabilization care claim for benefits. (as defined in paragraph (2)(B))
covered under the guidelines established “(b) GRIEVANCE SYSTEM.-Such system “(A) without the need for any prior author under section 1852(d)(2) of the Social Secushall include the following components with ization determination;
rity Act, the plan or issuer shall provide for respect to individuals who are participants, “(B) whether the health care provider fur reimbursement with respect to such services beneficiaries, or enrollees:
nishing such services is a participating pro provided to a participant, beneficiary, or en“(1) Written notification to all such indi vider with respect to such services;
rollee other than through a participating viduals and providers of the telephone num “(C) in a manner so that, if such services health care provider in a manner consistent bers and business addresses of the plan or are provided to a participant, beneficiary, or with subsection (a)(1)(C) (and shall otherwise issuer personnel responsible for resolution of enrollee
comply with such guidelines). grievances and appeals.
"(i) by a nonparticipating health care pro “(c) COVERAGE OF EMERGENCY AMBULANCE “(2) A system to record and document,
vider with or without prior authorization, or SERVICES.over a period of at least 3 previous years be "(ii) by a participating health care pro “(1) IN GENERAL.-If a group health plan, or ginning two months after the date of the en vider without prior authorization,
health insurance coverage provided by a actment of this Act, all grievances and ap
the participant, beneficiary, or enrollee is health insurance issuer, provides any benepeals made and their status.
not liable for amounts that exceed the fits with respect to ambulance services and “(3) A process providing processing and
amounts of liability that would be incurred emergency services, the plan or issuer shall resolution of grievances within 60 days.
if the services were provided by a partici cover emergency ambulance services (as de"(4) Procedures for follow-up action, in
pating health care provider with prior au fined in paragraph (2))) furnished under the cluding the methods to inform the person thorization; and
plan or coverage under the same terms and making the grievance of the resolution of
“(D) without regard to any other term or
conditions under subparagraphs (A) through the grievance. Grievances are not subject to appeal under
condition of such coverage (other than exclu (D) of subsection (a)(1) under which coverage
sion or coordination of benefits, or an affilithe previous provisions of this subtitle.
is provided for emergency services. ation or waiting period, permitted under sec
“(2) EMERGENCY AMBULANCE SERVICES.-For “Subtitle B-Access to Care
tion 2701 of the Public Health Service Act, purposes of this subsection, the term 'emer"SEC. 2811. CONSUMER CHOICE OPTION.
section 701 of the Employee Retirement In gency ambulance services' means ambulance “(a) IN GENERAL.-If a health insurance
come Security Act of 1974, or section 9801 of services (as defined for purposes of section issuer offers to enrollees health insurance the Internal Revenue Code of 1986, and other
1861(s)(7) of the Social Security Act) furcoverage in connection with a group health than applicable cost-sharing).
nished to transport an individual who has an plan which provides for coverage of services
“(2) DEFINITIONS.—In this section:
emergency medical condition (as defined in only if such services are furnished through
“(A) EMERGENCY MEDICAL CONDITION.—The subsection (a)(2)(A)) to a hospital for the rehealth care professionals and providers who
term “emergency medical condition' means ceipt of emergency services (as defined in are members of a network of health care pro
“(i) a medical condition manifesting itself
subsection (a)(2)(B)) in a case in which the fessionals and providers who have entered
by acute symptoms of sufficient severity (in emergency services are covered under the into a contract with the issuer to provide
cluding severe pain) such that a prudent plan or coverage pursuant to subsection such services, the issuer shall also offer to layperson, who possesses an average knowl
(a)(1) and a prudent layperson, with an aversuch enrollees (at the time of enrollment and edge of health and medicine, could reason
age knowledge of health and medicine, could during an annual open season as provided under subsection (c)) the option of health in
ably expect the absence of immediate med reasonably expect that the absence of such ical attention to result in a condition de
transport would result in placing the health surance coverage which provides for covscribed in clause (i), (ii), or (iii) of section
of the individual in serious jeopardy, serious erage of such services which are not fur1867(e)(1)(A) of the Social Security Act; and
impairment of bodily function, or serious nished through health care professionals and
"(ii) a medical condition manifesting itself
dysfunction of any bodily organ or part. providers who are members of such a net
in a neonate by acute symptoms of sufficient “SEC. 2814. ACCESS TO SPECIALTY CARE. work unless enrollees are offered such nonnetwork coverage through another health inseverity (including severe pain) such that a “(a) SPECIALTY CARE FOR COVERED SERV
prudent health care professional could rea“(b) ADDITIONAL COSTS.-The amount of
sonably expect the absence of immediate “(1) IN GENERAL.-Ifany additional premium charged by the
medical attention to result in a condition de “(A) an individual is a participant or benehealth insurance issuer for the additional
scribed in clause (i), (ii), or (iii) of section ficiary under a group health plan or an encost of the creation and maintenance of the 1867(e)(1)(A) of the Social Security Act.
rollee who is covered under health insurance option described in subsection (a) and the
(B) EMERGENCY SERVICES.- The term coverage offered by a health insurance amount of any additional cost sharing im'emergency services' means
issuer, posed under such option shall be borne by “(i) with respect to an emergency medical “(B) the individual has a condition or disthe enrollee unless it is paid by the health
condition described in subparagraph (A)(i) ease of sufficient seriousness and complexity plan sponsor through agreement with the
“(I) a medical screening examination (as to require treatment by a specialist or the health insurance issuer.
required under section 1867 of the Social Se individual requires physician pathology serv"(c) OPEN SEASON.-An enrollee may
curity Act) that is within the capability of ices, and change to the offering provided under this the emergency department of a hospital, in “(C) benefits for such treatment or services section only during a time period determined
cluding ancillary services routinely avail are provided under the plan or coverage, by the health insurance issuer. Such time pe
able to the emergency department to evalu the plan or issuer shall make or provide for riod shall occur at least annually.
ate such emergency medical condition, and a referral to a specialist who is available and "SEC. 2812. CHOICE OF HEALTH CARE PROFES. “(II) within the capabilities of the staff accessible (consistent with standards develSIONAL.
and facilities available at the hospital, such oped under section 2818) to provide the treat“(a) PRIMARY CARE.-If a group health further medical examination and treatment ment for such condition or disease or to proplan, or a health insurance issuer that offers as are required under section 1867 of such Act vide such services. health insurance coverage, requires or proto stabilize the patient; or
“(2) SPECIALIST DEFINED.—For purposes of vides for designation by a participant, bene “(ii) with respect to an emergency medical this subsection, the term “specialist' means, ficiary, or enrollee of a participating pri condition described in subparagraph (A)(ii), with respect to a condition or services, a mary care provider, then the plan or issuer medical treatment for such condition ren health care practitioner, facility, or center shall permit each participant, beneficiary, dered by a health care provider in a hospital or physician pathologist that has adequate and enrollee to designate any participating to a neonate, including available hospital expertise through appropriate training and primary care provider who is available to ac ancillary services in response to an urgent experience (including, in the case of a child, cept such individual.
request of a health care professional and to appropriate pediatric expertise and in the “(b) SPECIALISTS.-A group health plan and the extent necessary
to stabilize the case of a pregnant woman, appropriate oba health insurance issuer that offers health neonate.
stetrical expertise) to provide high quality insurance coverage shall permit each partici “(C) STABILIZE.—The term 'to stabilize' care in treating the condition or to provide pant, beneficiary, or enrollee to receive means, with respect to an emergency med physician pathology services. medically necessary or appropriate specialty ical condition, to provide such medical treat “(3) CARE UNDER REFERRAL.--A group care, pursuant to appropriate referral proce ment of the condition as may be necessary to health plan or health insurance issuer may dures, from any qualified participating assure, within reasonable medical prob require that the care provided to an indihealth care professional who is available to ability, that no material deterioration of the vidual pursuant to such referral under paraaccept such individual for such care.
condition is likely to result from or occur graph (1) with respect to treatment be