110th CONGRESS
1st Session
H. R. 979
To amend title I of the Employee Retirement Income Security Act
of 1974, title XXVII of the Public Health Service Act, and the Internal
Revenue Code of 1986 to protect consumers in managed care plans and other
health coverage.
IN THE HOUSE OF REPRESENTATIVES
February 12, 2007
Mr. NORWOOD (for himself and Mr. DINGELL) introduced the following bill;
which was referred to the Committee on Energy and Commerce, and in addition
to the Committees on Education and Labor and Ways and Means, for a period
to be subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee concerned
A BILL
To amend title I of the Employee Retirement Income Security Act
of 1974, title XXVII of the Public Health Service Act, and the Internal
Revenue Code of 1986 to protect consumers in managed care plans and other
health coverage.
Be it enacted by the Senate and House of Representatives of the United
States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title- This Act may be cited as the `Bipartisan Consensus Managed
Care Improvement Act of 2007'.
(b) Table of Contents- The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents.
TITLE I--IMPROVING MANAGED CARE
Subtitle A--Grievance and Appeals
Sec. 101. Utilization review activities.
Sec. 102. Internal appeals procedures.
Sec. 103. External appeals procedures.
Sec. 104. Establishment of a grievance process.
Subtitle B--Access to Care
Sec. 111. Consumer choice option.
Sec. 112. Choice of health care professional.
Sec. 113. Access to emergency care.
Sec. 114. Access to specialty care.
Sec. 115. Access to obstetrical and gynecological care.
Sec. 116. Access to pediatric care.
Sec. 117. Continuity of care.
Sec. 118. Access to needed prescription drugs.
Sec. 119. Coverage for individuals participating in approved clinical
trials.
Subtitle C--Access to Information
Sec. 121. Patient access to information.
Subtitle D--Protecting the Doctor-Patient Relationship
Sec. 131. Prohibition of interference with certain medical communications.
Sec. 132. Prohibition of discrimination against providers based on licensure.
Sec. 133. Prohibition against improper incentive arrangements.
Sec. 134. Payment of claims.
Sec. 135. Protection for patient advocacy.
Subtitle E--Definitions
Sec. 152. Preemption; State flexibility; construction.
Sec. 154. Coverage of limited scope plans.
TITLE II--APPLICATION OF QUALITY CARE STANDARDS TO GROUP HEALTH PLANS
AND HEALTH INSURANCE COVERAGE UNDER THE PUBLIC HEALTH SERVICE ACT
Sec. 201. Application to group health plans and group health insurance
coverage.
Sec. 202. Application to individual health insurance coverage.
TITLE III--AMENDMENTS TO THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF
1974
Sec. 301. Application of patient protection standards to group health
plans and group health insurance coverage under the Employee Retirement
Income Security Act of 1974.
Sec. 302. ERISA preemption not to apply to certain actions involving health
insurance policyholders.
TITLE IV--APPLICATION TO GROUP HEALTH PLANS UNDER THE INTERNAL REVENUE
CODE OF 1986
Sec. 401. Amendments to the Internal Revenue Code of 1986.
TITLE V--EFFECTIVE DATES; COORDINATION IN IMPLEMENTATION
Sec. 501. Effective dates.
Sec. 502. Coordination in implementation.
TITLE VI--HEALTH CARE PAPERWORK SIMPLIFICATION
Sec. 601. Health care paperwork simplification.
TITLE I--IMPROVING MANAGED CARE
Subtitle A--Grievance and Appeals
SEC. 101. UTILIZATION REVIEW ACTIVITIES.
(a) Compliance With Requirements-
(1) IN GENERAL- A group health plan, and a health insurance issuer that
provides health insurance coverage, shall conduct utilization review activities
in connection with the provision of benefits under such plan or coverage
only in accordance with a utilization review program that meets the requirements
of this section.
(2) USE OF OUTSIDE AGENTS- Nothing in this section shall be construed
as preventing a group health plan or health insurance issuer from arranging
through a contract or otherwise for persons or entities to conduct utilization
review activities on behalf of the plan or issuer, so long as such activities
are conducted in accordance with a utilization review program that meets
the requirements of this section.
(3) UTILIZATION REVIEW DEFINED- For purposes of this section, the terms
`utilization review' and `utilization review activities' mean procedures
used to monitor or evaluate the use or coverage, clinical necessity, appropriateness,
efficacy, or efficiency of health care services, procedures or settings,
and includes prospective review, concurrent review, second opinions, case
management, discharge planning, or retrospective review.
(b) Written Policies and Criteria-
(1) WRITTEN POLICIES- A utilization review program shall be conducted
consistent with written policies and procedures that govern all aspects
of the program.
(2) USE OF WRITTEN CRITERIA-
(A) IN GENERAL- Such a program shall utilize written clinical review
criteria developed with input from a range of appropriate actively practicing
health care professionals, as determined by the plan, pursuant to the
program. Such criteria shall include written clinical review criteria
that are based on valid clinical evidence where available and that are
directed specifically at meeting the needs of at-risk populations and
covered individuals with chronic conditions or severe illnesses, including
gender-specific criteria and pediatric-specific criteria where available
and appropriate.
(B) CONTINUING USE OF STANDARDS IN RETROSPECTIVE REVIEW- If a health
care service has been specifically pre-authorized or approved for an
enrollee under such a program, the program shall not, pursuant to retrospective
review, revise or modify the specific standards, criteria, or procedures
used for the utilization review for procedures, treatment, and services
delivered to the enrollee during the same course of treatment.
(C) REVIEW OF SAMPLE OF CLAIMS DENIALS- Such a program shall provide
for an evaluation of the clinical appropriateness of at least a sample
of denials of claims for benefits.
(c) Conduct of Program Activities-
(1) ADMINISTRATION BY HEALTH CARE PROFESSIONALS- A utilization review
program shall be administered by qualified health care professionals who
shall oversee review decisions.
(2) USE OF QUALIFIED, INDEPENDENT PERSONNEL-
(A) IN GENERAL- A utilization review program shall provide for the conduct
of utilization review activities only through personnel who are qualified
and have received appropriate training in the conduct of such activities
under the program.
(B) PROHIBITION OF CONTINGENT COMPENSATION ARRANGEMENTS- Such a program
shall not, with respect to utilization review activities, permit or
provide compensation or anything of value to its employees, agents,
or contractors in a manner that encourages denials of claims for benefits.
(C) PROHIBITION OF CONFLICTS- Such a program shall not permit a health
care professional who is providing health care services to an individual
to perform utilization review activities in connection with the health
care services being provided to the individual.
(3) ACCESSIBILITY OF REVIEW- Such a program shall provide that appropriate
personnel performing utilization review activities under the program,
including the utilization review administrator, are reasonably accessible
by toll-free telephone during normal business hours to discuss patient
care and allow response to telephone requests, and that appropriate provision
is made to receive and respond promptly to calls received during other
hours.
(4) LIMITS ON FREQUENCY- Such a program shall not provide for the performance
of utilization review activities with respect to a class of services furnished
to an individual more frequently than is reasonably required to assess
whether the services under review are medically necessary or appropriate.
(d) Deadline for Determinations-
(1) PRIOR AUTHORIZATION SERVICES-
(A) IN GENERAL- Except as provided in paragraph (2), in the case of
a utilization review activity involving the prior authorization of health
care items and services for an individual, the utilization review program
shall make a determination concerning such authorization, and provide
notice of the determination to the individual or the individual's designee
and the individual's health care provider by telephone and in printed
form, as soon as possible in accordance with the medical exigencies
of the case, and in no event later than the deadline specified in subparagraph
(B).
(i) IN GENERAL- Subject to clauses (ii) and (iii), the deadline specified
in this subparagraph is 14 days after the date of receipt of the request
for prior authorization.
(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, and
(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,
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 72 hours
after the time of the request for prior authorization.
(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 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 individual, 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 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,
AND POST-STABILIZATION CARE- For waiver of prior authorization requirements
in certain cases involving emergency services and maintenance care and
post-stabilization care, see subsections (a)(1) and (b) 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 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), for eligibility, 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, means 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 benefits (including items and services) required to
be provided under this title.
SEC. 102. INTERNAL APPEALS PROCEDURES.
(1) IN GENERAL- Each group health plan, and each health insurance issuer
offering health insurance coverage--
(A) shall provide adequate notice in writing to any participant or beneficiary
under such plan, or enrollee under such coverage, whose claim for benefits
under the plan or coverage has been denied (within the meaning of section
101(f)(2)), setting forth the specific reasons for such denial of claim
for benefits and rights to any further review or appeal, written in
a manner calculated 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 individual 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 writing.
(b) Internal Review Process-
(A) IN GENERAL- A review of a denial of claim under this section shall
be made by an individual who--
(i) in a case involving medical judgment, shall be a physician or,
in the case of limited scope coverage (as defined in subparagraph
(B), shall be an appropriate specialist;
(ii) has been selected by the plan or issuer; and
(iii) did not make the initial denial in the internally appealable
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 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 date of receipt of the request
for internal review.
(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, and
(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,
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 72 hours
after the time of the request for review.
(c) Expedited Review Process-
(1) IN GENERAL- A group health plan, and a health insurance issuer, shall
establish procedures in writing for the expedited consideration of requests
for review under subsection (b) in situations--
(A) in which, as determined by the plan or issuer or as certified in
writing by a treating health care professional, the application of the
normal timeframe for making a determination could seriously jeopardize
the life or health of the participant, beneficiary, or enrollee or such
an individual's ability to regain maximum function; or
(B) described in section 101(d)(2) (relating to requests for continuation
of ongoing care which would otherwise be reduced or terminated).
(2) PROCESS- Under such procedures--
(A) the request for expedited review may be submitted orally or in writing
by an individual or provider who is otherwise entitled to request the
review;
(B) all necessary information, including the plan's or issuer's decision,
shall be transmitted between the plan or issuer and the requester by
telephone, facsimile, or other similarly expeditious available method;
and
(C) the plan or issuer shall expedite the review in the case of any
of the situations described in subparagraph (A) or (B) of paragraph
(1).
(3) DEADLINE FOR DECISION- The decision on the expedited review must be
made and communicated to the parties as soon as possible in accordance
with the medical exigencies of the case, and in no event later than 72
hours after the time of receipt of the request for expedited review, except
that in a case described in paragraph (1)(B), the decision must be made
before the end of the approved period of care.
(d) Waiver of Process- A plan or issuer may waive its rights for an internal
review under subsection (b). In such case the participant, beneficiary,
or enrollee involved (and any designee or provider involved) shall be relieved
of any obligation to complete the review involved and may, at the option
of such participant, beneficiary, enrollee, designee, or provider, proceed
directly to seek further appeal through any applicable external appeals
process.
SEC. 103. EXTERNAL APPEALS PROCEDURES.
(a) Right to External Appeal-
(1) IN GENERAL- A group health plan, and a health insurance issuer offering
health insurance coverage, shall provide for an external appeals process
that meets the requirements of this section in the case of an externally
appealable decision described in paragraph (2), for which a timely appeal
is made either by the plan or issuer or by the participant, beneficiary,
or enrollee (and any provider or other person acting on behalf of such
an individual with the individual's consent or without such consent if
such an individual is medically unable to provide such consent). The appropriate
Secretary shall establish standards to carry out such requirements.
(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
101(f)(2))--
(i) that 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 which the decision as to whether a benefit is covered involves
a medical judgment.
(B) INCLUSION- Such term also includes a failure to meet an applicable
deadline for internal review under section 102.
(C) EXCLUSIONS- Such term does not include--
(i) specific exclusions or express limitations on the amount, duration,
or scope of coverage that do not involve medical judgment; or
(ii) a decision regarding whether an individual is a participant,
beneficiary, or enrollee under the plan or coverage.
(3) EXHAUSTION OF INTERNAL REVIEW PROCESS- Except as provided under section
102(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 102, but only if the decision is made
in a timely basis consistent with the deadlines provided under this subtitle.
(4) FILING FEE REQUIREMENT-
(A) IN GENERAL- Subject to subparagraph (B), a plan or issuer may condition
the use of an external appeal process upon payment to the plan or issuer
of a filing fee that does not exceed $25.
(B) EXCEPTION FOR INDIGENCY- The plan or issuer may not require payment
of the filing fee in the case of an individual participant, beneficiary,
or enrollee who certifies (in a form and manner specified in guidelines
established by the Secretary of Health and Human Services) that the
individual is indigent (as defined in such guidelines).
(C) 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 or modify the denial of
a claim for benefits which is the subject of the appeal.
(b) General Elements of External Appeals Process-
(1) CONTRACT WITH QUALIFIED EXTERNAL APPEAL ENTITY-
(A) CONTRACT REQUIREMENT- Except as provided in subparagraph (D), the
external appeal process under this section of a plan or issuer shall
be conducted under a contract between the plan or issuer and one or
more qualified external appeal entities (as defined in subsection (c)).
(B) LIMITATION ON PLAN OR ISSUER SELECTION- The applicable authority
shall implement procedures--
(i) 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, and
(ii) for auditing a sample of decisions by such entities to assure
that no such decisions are made in a biased manner.
(C) OTHER TERMS AND CONDITIONS- The terms and conditions of a contract
under this paragraph shall be consistent with the standards the appropriate
Secretary shall establish to assure there is no real or apparent conflict
of interest in the conduct of external appeal activities. Such contract
shall provide that all costs of the process (except those incurred by
the participant, beneficiary, enrollee, or treating professional in
support of the appeal) shall be paid by the plan or issuer, and not
by the participant, beneficiary, or enrollee. The previous sentence
shall not be construed as applying to the imposition of a filing fee
under subsection (a)(4).
(D) STATE AUTHORITY WITH RESPECT QUALIFIED EXTERNAL APPEAL ENTITY FOR
HEALTH INSURANCE ISSUERS- With respect to health insurance issuers offering
health insurance coverage in a State, the State may provide for external
review activities to be conducted by a qualified external appeal entity
that is designated by the State or that is selected by the State in
a manner determined by the State to assure an unbiased determination.
(2) ELEMENTS OF PROCESS- An external appeal process shall be conducted
consistent with standards established by the appropriate Secretary that
include at least the following:
(A) FAIR AND DE NOVO DETERMINATION- The process shall provide for a
fair, de novo determination. However, nothing in this paragraph shall
be construed as providing for coverage of items and services for which
benefits are specifically excluded under the plan or coverage.
(B) STANDARD OF REVIEW- An external appeal entity shall determine whether
the plan's or issuer's decision is in accordance with the medical needs
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 subparagraph (D). If the entity determines the decision is in
accordance with such needs, the entity shall affirm the decision and
to the extent that the entity determines the decision is not in accordance
with such needs, the entity shall reverse or modify the decision.
(C) CONSIDERATION OF PLAN OR COVERAGE DEFINITIONS- In making such determination,
the external appeal entity shall consider (but not be bound by) 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.
(i) IN GENERAL- An external appeal entity shall include, among the
evidence taken into consideration--
(I) the decision made by the plan or issuer upon internal review
under section 102 and any guidelines or standards used by the plan
or issuer in reaching such decision;
(II) any personal health and medical information supplied with respect
to the individual whose denial of claim for benefits has been appealed;
and
(III) the opinion of the individual's treating physician or health
care professional.
(ii) 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 studies that meet professionally recognized standards
of validity and replicability or that have been published in peer-reviewed
journals.
(II) The results of professional consensus conferences conducted
or financed in whole or in part by one or more government agencies.
(III) Practice and treatment guidelines prepared or financed in
whole or in part by government agencies.
(IV) Government-issued coverage and treatment policies.
(V) Community standard of care and generally accepted principles
of professional medical practice.
(VI) 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.
(VII) 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- 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; and
(iii) for purposes of initiating an external review, whether the internal
review process has been completed.
(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
timely access to the external appeal entity 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.
(H) TIMELY DECISIONS- A determination by the external appeal entity
on the decision shall--
(i) be made orally or in writing and, if it is made orally, shall
be supplied to the parties in writing 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, 72 hours after the time) of requesting
an external appeal of the decision;
(iii) state, in layperson's language, the basis for the 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 further review
by the courts (or other process) of the external appeal determination.
(I) COMPLIANCE WITH DETERMINATION- If the external appeal entity reverses
or modifies the denial of a claim for benefits, the plan or issuer shall--
(i) upon the receipt of the determination, authorize benefits in accordance
with such determination;
(ii) take such actions as may be necessary to provide benefits (including
items or services) in a timely manner consistent with such determination;
and
(iii) submit information to the entity documenting compliance with
the entity's determination and this subparagraph.
(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 a panel of
not fewer than 3 clinical peers.
(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).
(D) The entity meets such other requirements as the appropriate Secretary
may impose.
(2) INITIAL CERTIFICATION OF EXTERNAL APPEAL ENTITIES-
(A) IN GENERAL- In order to be treated as a qualified external appeal
entity with respect to--
(i) a group health plan, the entity must be certified (and, in accordance
with subparagraph (B), periodically recertified) as meeting the requirements
of paragraph (1)--
(I) by the Secretary of Labor;
(II) under a process recognized or approved by the Secretary of
Labor; or
(III) to the extent provided in subparagraph (C)(i), by a qualified
private standard-setting organization (certified under such subparagraph);
or
(ii) a 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 of Health and Human
Services, under a process recognized or approved by such Secretary,
or to the extent provided in subparagraph (C)(ii), by a qualified
private standard-setting organization (certified under such subparagraph).
(B) RECERTIFICATION PROCESS- The appropriate 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) such information as may be necessary to assure the independence
of the entity from the plans or issuers for which external appeal
activities are being conducted.
(C) CERTIFICATION OF QUALIFIED PRIVATE STANDARD-SETTING ORGANIZATIONS-
(i) FOR EXTERNAL REVIEWS UNDER GROUP HEALTH PLANS- For purposes of
subparagraph (A)(i)(III), the Secretary of Labor may provide for a
process for certification (and periodic recertification) of qualified
private standard-setting organizations which provide for certification
of external review entities. Such an organization shall only be certified
if the organization does not certify an external review entity unless
it meets standards required for certification of such an entity by
such Secretary under subparagraph (A)(i)(I).
(ii) FOR EXTERNAL REVIEWS OF HEALTH INSURANCE ISSUERS- For purposes
of subparagraph (A)(ii)(II), the Secretary of Health and Human Services
may provide for a process for certification (and periodic recertification)
of qualified private standard-setting organizations which provide
for certification of external review entities. Such an organization
shall only be certified if the organization does not certify an external
review entity unless it meets standards required for certification
of such an entity by such Secretary under subparagraph (A)(ii)(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 does not have a familial, financial, or professional
relationship 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) except as provided in paragraph (4), the plan and the issuer
have no recourse against the peer or entity in connection with the
external review; and
(iv) the peer or entity does not otherwise have a conflict of interest
with a related party as determined under any regulations which the
Secretary may prescribe.
(B) RELATED PARTY- For purposes of this paragraph, the term `related
party' means--
(I) a group health plan or health insurance coverage offered in
connection with such a plan, the plan or the health insurance issuer
offering such coverage, or
(II) individual health insurance coverage, the health insurance
issuer offering such coverage,
or any plan sponsor, fiduciary, officer, director, or management employee
of such plan or issuer;
(ii) the health care professional that provided the health care involved
in the coverage decision;
(iii) the institution at which the health care involved in the coverage
decision is provided;
(iv) the manufacturer of any drug or other item that was included
in the health care involved in the coverage decision; or
(v) any other party determined under any regulations which the Secretary
may prescribe to have a substantial interest in the coverage decision.
(4) LIMITATION ON LIABILITY OF REVIEWERS- No qualified external appeal
entity having a contract with a plan or issuer under this part and no
person who is employed by any such entity or who furnishes professional
services to such entity, shall be held by reason of the performance of
any duty, function, or activity required or authorized pursuant to this
section, to have violated any criminal law, or to be civilly liable under
any law of the United States or of any State (or political subdivision
thereof) if due care was exercised in the performance of such duty, function,
or activity and there was no actual malice or gross misconduct in the
performance of such duty, function, or activity.
(d) External Appeal Determination Binding on Plan- The determination by
an external appeal entity under this section is binding on the plan and
issuer involved in the determination.
(e) Penalties Against Authorized Officials for Refusing to Authorize the
Determination of an External Review Entity-
(1) MONETARY PENALTIES- In any case in which the determination of an external
review entity is not followed by a group health plan, or by a health insurance
issuer offering health insurance coverage, any person who, acting in the
capacity of authorizing the benefit, causes such refusal may, in the discretion
in a court of competent jurisdiction, be liable to an aggrieved participant,
beneficiary, or enrollee for a civil penalty in an amount of up to $1,000
a day from the date on which the determination was transmitted to the
plan or issuer by the external review entity until the date the refusal
to provide the benefit is corrected.
(2) CEASE AND DESIST ORDER AND ORDER OF ATTORNEY'S FEES- In any action
described in paragraph (1) brought by a participant, beneficiary, or enrollee
with respect to a group health plan, or a health insurance issuer offering
health insurance coverage, in which a plaintiff alleges that a person
referred to in such paragraph has taken an action resulting in a refusal
of a benefit determined by an external appeal entity in violation of such
terms of the plan, coverage, or this subtitle, or has failed to take an
action for which such person is responsible under the plan, coverage,
or this title and which is necessary under the plan or coverage for authorizing
a benefit, the court shall cause to be served on the defendant an order
requiring the defendant--
(A) to cease and desist from the alleged action or failure to act; and
(B) to pay to the plaintiff a reasonable attorney's fee and other reasonable
costs relating to the prosecution of the action on the charges on which
the plaintiff prevails.
(3) ADDITIONAL CIVIL PENALTIES-
(A) IN GENERAL- In addition to any penalty imposed under paragraph (1)
or (2), the appropriate Secretary may assess a civil penalty against
a person acting in the capacity of authorizing a benefit determined
by an external review entity for one or more group health plans, or
health insurance issuers offering health insurance coverage, for--
(i) any pattern or practice of repeated refusal to authorize a benefit
determined by an external appeal entity in violation of the terms
of such a plan, coverage, or this title; or
(ii) any pattern or practice of repeated violations of the requirements
of this section with respect to such plan or plans or coverage.
(B) STANDARD OF PROOF AND AMOUNT OF PENALTY- Such penalty shall be payable
only upon proof by clear and convincing evidence of such pattern or
practice and shall be in an amount not to exceed the lesser of--
(i) 25 percent of the aggregate value of benefits shown by the appropriate
Secretary to have not been provided, or unlawfully delayed, in violation
of this section under such pattern or practice, or
(4) REMOVAL AND DISQUALIFICATION- Any person acting in the capacity of
authorizing benefits who has engaged in any such pattern or practice described
in paragraph (3)(A) with respect to a plan or coverage, upon the petition
of the appropriate Secretary, may be removed by the court from such position,
and from any other involvement, with respect to such a plan or coverage,
and may be precluded from returning to any such position or involvement
for a period determined by the court.
(f) Protection of Legal Rights- Nothing in this subtitle shall be construed
as altering or eliminating any cause of action or legal rights or remedies
of participants, beneficiaries, enrollees, and others under State or Federal
law (including sections 502 and 503 of the Employee Retirement Income Security
Act of 1974), including the right to file judicial actions to enforce actions.
SEC. 104. ESTABLISHMENT OF A GRIEVANCE PROCESS.
(a) Establishment of Grievance System-
(1) IN GENERAL- A group health plan, and a health insurance issuer in
connection with the provision of health insurance coverage, shall establish
and maintain a system to provide for the presentation and resolution of
oral and written grievances brought by individuals who are participants,
beneficiaries, or enrollees, or health care providers or other individuals
acting on behalf of an individual and with the individual's consent or
without such consent if the individual is medically unable to provide
such consent, regarding any aspect of the plan's or issuer's services.
(2) GRIEVANCE DEFINED- In this section, the term `grievance' means any
question, complaint, or concern brought by a participant, beneficiary
or enrollee that is not a claim for benefits (as defined in section 101(f)(1)).
(b) Grievance System- Such system shall include the following components
with respect to individuals who are participants, beneficiaries, or enrollees:
(1) Written notification to all such individuals and providers of the
telephone numbers and business addresses of the plan or issuer personnel
responsible for resolution of grievances and appeals.
(2) A system to record and document, over a period of at least 3 previous
years, all grievances and appeals made and their status.
(3) A process providing for timely processing and resolution of grievances.
(4) Procedures for follow-up action, including the methods to inform the
person making the grievance of the resolution of the grievance.
Grievances are not subject to appeal under the previous provisions of this
subtitle.
Subtitle B--Access to Care
SEC. 111. CONSUMER CHOICE OPTION.
(a) In General- If a health insurance issuer offers to enrollees health
insurance coverage in connection with a group health plan which provides
for coverage of services only if such services are furnished through health
care professionals and providers who are members of a network of health
care professionals and providers who have entered into a contract with the
issuer to provide such services, the issuer shall also offer to such enrollees
(at the time of enrollment and during an annual open season as provided
under subsection (c)) the option of health insurance coverage which provides
for coverage of such services which are not furnished through health care
professionals and providers who are members of such a network unless enrollees
are offered such non-network coverage through another group health plan
or through another health insurance issuer in the group market.
(b) Additional Costs- The amount of any additional premium charged by the
health insurance issuer for the additional cost of the creation and maintenance
of the option described in subsection (a) and the amount of any additional
cost sharing imposed under such option shall be borne by the enrollee unless
it is paid by the health plan sponsor through agreement with the health
insurance issuer.
(c) Open Season- An enrollee may change to the offering provided under this
section only during a time period determined by the health insurance issuer.
Such time period shall occur at least annually.
SEC. 112. CHOICE OF HEALTH CARE PROFESSIONAL.
(a) Primary Care- If a group health plan, or a health insurance issuer that
offers health insurance coverage, requires or provides for designation by
a participant, beneficiary, or enrollee of a participating primary care
provider, then the plan or issuer shall permit each participant, beneficiary,
and enrollee to designate any participating primary care provider who is
available to accept such individual.
(1) IN GENERAL- Subject to paragraph (2), a group health plan and a health
insurance issuer that offers health insurance coverage shall permit each
participant, beneficiary, or enrollee to receive medically necessary or
appropriate specialty care, pursuant to appropriate referral procedures,
from any qualified participating health care professional who is available
to accept such individual for such care.
(2) LIMITATION- Paragraph (1) shall not apply to specialty care if the
plan or issuer clearly informs participants, beneficiaries, and enrollees
of the limitations on choice of participating health care professionals
with respect to such care.
SEC. 113. ACCESS TO EMERGENCY CARE.
(a) Coverage of Emergency Services-
(1) IN GENERAL- If a group health plan, or health insurance coverage offered
by a health insurance issuer, provides any benefits with respect to services
in an emergency department of a hospital, the plan or issuer shall cover
emergency services (as defined in paragraph (2)(B))--
(A) without the need for any prior authorization determination;
(B) whether or not the health care provider furnishing such services
is a participating provider with respect to such services;
(C) in a manner so that, if such services are provided to a participant,
beneficiary, or enrollee--
(i) by a nonparticipating health care provider with or without prior
authorization, or
(ii) by a participating health care provider without prior authorization,
the participant, beneficiary, or enrollee is not liable for amounts
that exceed the amounts of liability that would be incurred if the services
were provided by a participating health care provider with prior authorization;
and
(D) without regard to any other term or condition of such coverage (other
than exclusion or coordination of benefits, or an affiliation or waiting
period, permitted under section 2701 of the Public Health Service Act,
section 701 of the Employee Retirement Income Security Act of 1974,
or section 9801 of the Internal Revenue Code of 1986, and other than
applicable cost-sharing).
(2) DEFINITIONS- In this section:
(A) EMERGENCY MEDICAL CONDITION BASED ON PRUDENT LAYPERSON STANDARD-
The term `emergency medical condition' means a medical condition manifesting
itself by acute symptoms of sufficient severity (including severe pain)
such that a prudent layperson, who possesses an average knowledge of
health and medicine, could reasonably expect the absence of immediate
medical attention to result in a condition described in clause (i),
(ii), or (iii) of section 1867(e)(1)(A) of the Social Security Act.
(B) EMERGENCY SERVICES- The term `emergency services' means--
(i) a medical screening examination (as required under section 1867
of the Social Security Act) that is within the capability of the emergency
department of a hospital, including ancillary services routinely available
to the emergency department to evaluate an emergency medical condition
(as defined in subparagraph (A)), and
(ii) within the capabilities of the staff and facilities available
at the hospital, such further medical examination and treatment as
are required under section 1867 of such Act to stabilize the patient.
(C) STABILIZE- The term `to stabilize' means, with respect to an emergency
medical condition, to provide such medical treatment of the condition
as may be necessary to assure, within reasonable medical probability,
that no material deterioration of the condition is likely to result
from or occur during the transfer of the individual from a facility.
(b) Reimbursement for Maintenance Care and Post-Stabilization Care- If benefits
are available under a group health plan, or under health insurance coverage
offered by a health insurance issuer, with respect to maintenance care or
post-stabilization care covered under the guidelines established under section
1852(d)(2) of the Social Security Act, the plan or issuer shall provide
for reimbursement with respect to such services provided to a participant,
beneficiary, or enrollee other than through a participating health care
provider in a manner consistent with subsection (a)(1)(C) (and shall otherwise
comply with such guidelines).
SEC. 114. ACCESS TO SPECIALTY CARE.
(a) Specialty Care for Covered Services-
(A) an individual is a participant or beneficiary under a group health
plan or an enrollee who is covered under health insurance coverage offered
by a health insurance issuer,
(B) the individual has a condition or disease of sufficient seriousness
and complexity to require treatment by a specialist, and
(C) benefits for such treatment are provided under the plan or coverage,
the plan or issuer shall make or provide for a referral to a specialist
who is available and accessible to provide the treatment for such condition
or disease.
(2) SPECIALIST DEFINED- For purposes of this subsection, the term `specialist'
means, with respect to a condition, a health care practitioner, facility,
or center that has adequate expertise through appropriate training and
experience (including, in the case of a child, appropriate pediatric expertise)
to provide high quality care in treating the condition.
(3) CARE UNDER REFERRAL- A group health plan or health insurance issuer
may require that the care provided to an individual pursuant to such referral
under paragraph (1) be--
(A) pursuant to a treatment plan, only if the treatment plan is developed
by the specialist and approved by the plan or issuer, in consultation
with the designated primary care provider or specialist and the individual
(or the individual's designee), and
(B) in accordance with applicable quality assurance and utilization
review standards of the plan or issuer.
Nothing in this subsection shall be construed as preventing such a treatment
plan for an individual from requiring a specialist to provide the primary
care provider with regular updates on the specialty care provided, as
well as all necessary medical information.
(4) REFERRALS TO PARTICIPATING PROVIDERS- A group health plan or health
insurance issuer is not required under paragraph (1) to provide for a
referral to a specialist that is not a participating provider, unless
the plan or issuer does not have an appropriate specialist that is available
and accessible to treat the individual's condition and that is a participating
provider with respect to such treatment.
(5) TREATMENT OF NONPARTICIPATING PROVIDERS- If a plan or issuer refers
an individual to a nonparticipating specialist pursuant to paragraph (1),
services provided pursuant to the approved treatment plan (if any) shall
be provided at no additional cost to the individual beyond what the individual
would otherwise pay for services received by such a specialist that is
a participating provider.
(b) Specialists as Gatekeeper for Treatment of Ongoing Special Conditions-
(1) IN GENERAL- A group health plan, or a health insurance issuer, in
connection with the provision of health insurance coverage, shall have
a procedure by which an individual who is a participant, beneficiary,
or enrollee and who has an ongoing special condition (as defined in paragraph
(3)) may request and receive a referral to a specialist for such condition
who shall be responsible for and capable of providing and coordinating
the individual's care with respect to the condition. Under such procedures
if such an individual's care would most appropriately be coordinated by
such a specialist, such plan or issuer shall refer the individual to such
specialist.
(2) TREATMENT FOR RELATED REFERRALS- Such specialists shall be permitted
to treat the individual without a referral from the individual's primary
care provider and may authorize such referrals, procedures, tests, and
other medical services as the individual's primary care provider would
otherwise be permitted to provide or authorize, subject to the terms of
the treatment (referred to in subsection (a)(3)(A)) with respect to the
ongoing special condition.
(3) ONGOING SPECIAL CONDITION DEFINED- In this subsection, the term `ongoing
special condition' means a condition or disease that--
(A) is life-threatening, degenerative, or disabling, and
(B) requires specialized medical care over a prolonged period of time.
(4) TERMS OF REFERRAL- The provisions of paragraphs (3) through (5) of
subsection (a) apply with respect to referrals under paragraph (1) of
this subsection in the same manner as they apply to referrals under subsection
(a)(1).
(1) IN GENERAL- A group health plan, and a health insurance issuer in
connection with the provision of health insurance coverage, shall have
a procedure by which an individual who is a participant, beneficiary,
or enrollee and who has a condition that requires ongoing care from a
specialist may receive a standing referral to such specialist for treatment
of such condition. If the plan or issuer, or if the primary care provider
in consultation with the medical director of the plan or issuer and the
specialist (if any), determines that such a standing referral is appropriate,
the plan or issuer shall make such a referral to such a specialist if
the individual so desires.
(2) TERMS OF REFERRAL- The provisions of paragraphs (3) through (5) of
subsection (a) apply with respect to referrals under paragraph (1) of
this subsection in the same manner as they apply to referrals under subsection
(a)(1).
SEC. 115. ACCESS TO OBSTETRICAL AND GYNECOLOGICAL CARE.
(a) In General- If a group health plan, or a health insurance issuer in
connection with the provision of health insurance coverage, requires or
provides for a participant, beneficiary, or enrollee to designate a participating
primary care health care professional, the plan or issuer--
(1) may not require authorization or a referral by the individual's primary
care health care professional or otherwise for coverage of gynecological
care (including preventive women's health examinations) and pregnancy-related
services provided by a participating health care professional, including
a physician, who specializes in obstetrics and gynecology to the extent
such care is otherwise covered, and
(2) shall treat the ordering of other obstetrical or gynecological care
by such a participating professional as the authorization of the primary
care health care professional with respect to such care under the plan
or coverage.
(b) Construction- Nothing in subsection (a) shall be construed to--
(1) waive any exclusions of coverage under the terms of the plan or health
insurance coverage with respect to coverage of obstetrical or gynecological
care; or
(2) preclude the group health plan or health insurance issuer involved
from requiring that the obstetrical or gynecological provider notify the
primary care health care professional or the plan or issuer of treatment
decisions.
SEC. 116. ACCESS TO PEDIATRIC CARE.
(a) Pediatric Care- If a group health plan, or a health insurance issuer
in connection with the provision of health insurance coverage, requires
or provides for an enrollee to designate a participating primary care provider
for a child of such enrollee, the plan or issuer shall permit the enrollee
to designate a physician who specializes in pediatrics as the child's primary
care provider.
(b) Construction- Nothing in subsection (a) shall be construed to waive
any exclusions of coverage under the terms of the plan or health insurance
coverage with respect to coverage of pediatric care.
SEC. 117. CONTINUITY OF CARE.
(1) TERMINATION OF PROVIDER- If a contract between a group health plan,
or a health insurance issuer in connection with the provision of health
insurance coverage, and a health care provider is terminated (as defined
in paragraph (3)(B)), or benefits or coverage provided by a health care
provider are terminated because of a change in the terms of provider participation
in a group health plan, and an individual who is a participant, beneficiary,
or enrollee in the plan or coverage is undergoing treatment from the provider
for an ongoing special condition (as defined in paragraph (3)(A)) at the
time of such termination, the plan or issuer shall--
(A) notify the individual on a timely basis of such termination and
of the right to elect continuation of coverage of treatment by the provider
under this section; and
(B) subject to subsection (c), permit the individual to elect to continue
to be covered with respect to treatment by the provider of such condition
during a transitional period (provided under subsection (b)).
(2) TREATMENT OF TERMINATION OF CONTRACT WITH HEALTH INSURANCE ISSUER-
If a contract for the provision of health insurance coverage between a
group health plan and a health insurance issuer is terminated and, as
a result of such termination, coverage of services of a health care provider
is terminated with respect to an individual, the provisions of paragraph
(1) (and the succeeding provisions of this section) shall apply under
the plan in the same manner as if there had been a contract between the
plan and the provider that had been terminated, but only with respect
to benefits that are covered under the plan after the contract termination.
(3) DEFINITIONS- For purposes of this section:
(A) ONGOING SPECIAL CONDITION- The term `ongoing special condition'
has the meaning given such term in section 114(b)(3), and also includes
pregnancy.
(B) TERMINATION- The term `terminated' includes, with respect to a contract,
the expiration or nonrenewal of the contract, but does not include a
termination of the contract by the plan or issuer for failure to meet
applicable quality standards or for fraud.
(1) IN GENERAL- Except as provided in paragraphs (2) through (4), the
transitional period under this subsection shall extend up to 90 days (as
determined by the treating health care professional) after the date of
the notice described in subsection (a)(1)(A) of the provider's termination.
(2) SCHEDULED SURGERY AND ORGAN TRANSPLANTATION- If surgery or organ transplantation
was scheduled for an individual before the date of the announcement of
the termination of the provider status under subsection (a)(1)(A) or if
the individual on such date was on an established waiting list or otherwise
scheduled to have such surgery or transplantation, the transitional period
under this subsection with respect to the surgery or transplantation shall
extend beyond the period under paragraph (1) and until the date of discharge
of the individual after completion of the surgery or transplantation.
(A) a participant, beneficiary, or enrollee was determined to be pregnant
at the time of a provider's termination of participation, and
(B) the provider was treating the pregnancy before date of the termination,
the transitional period under this subsection with respect to provider's
treatment of the pregnancy shall extend through the provision of post-partum
care directly related to the delivery.
(4) TERMINAL ILLNESS- If--
(A) a participant, beneficiary, or enrollee was determined to be terminally
ill (as determined under section 1861(dd)(3)(A) of the Social Security
Act) at the time of a provider's termination of participation, and
(B) the provider was treating the terminal illness before the date of
termination,
the transitional period under this subsection shall extend for the remainder
of the individual's life for care directly related to the treatment of
the terminal illness or its medical manifestations.
(c) Permissible Terms and Conditions- A group health plan or health insurance
issuer may condition coverage of continued treatment by a provider under
subsection (a)(1)(B) upon the individual notifying the plan of the election
of continued coverage and upon the provider agreeing to the following terms
and conditions:
(1) The provider agrees to accept reimbursement from the plan or issuer
and individual involved (with respect to cost-sharing) at the rates applicable
prior to the start of the transitional period as payment in full (or,
in the case described in subsection (a)(2), at the rates applicable under
the replacement plan or issuer after the date of the termination of the
contract with the health insurance issuer) and not to impose cost-sharing
with respect to the individual in an amount that would exceed the cost-sharing
that could have been imposed if the contract referred to in subsection
(a)(1) had not been terminated.
(2) The provider agrees to adhere to the quality assurance standards of
the plan or issuer responsible for payment under paragraph (1) and to
provide to such plan or issuer necessary medical information related to
the care provided.
(3) The provider agrees otherwise to adhere to such plan's or issuer's
policies and procedures, including procedures regarding referrals and
obtaining prior authorization and providing services pursuant to a treatment
plan (if any) approved by the plan or issuer.
(d) Construction- Nothing in this section shall be construed to require
the coverage of benefits which would not have been covered if the provider
involved remained a participating provider.
SEC. 118. ACCESS TO NEEDED PRESCRIPTION DRUGS.
If a group health plan, or health insurance issuer that offers health insurance
coverage, provides benefits with respect to prescription drugs but the coverage
limits such benefits to drugs included in a formulary, the plan or issuer
shall--
(1) ensure participation of participating physicians and pharmacists in
the development of the formulary;
(2) disclose to providers and, disclose upon request under section 121(c)(5)
to participants, beneficiaries, and enrollees, the nature of the formulary
restrictions; and
(3) consistent with the standards for a utilization review program under
section 101, provide for exceptions from the formulary limitation when
a non-formulary alternative is medically indicated.
SEC. 119. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CLINICAL
TRIALS.
(1) IN GENERAL- If a group health plan, or health insurance issuer that
is providing health insurance coverage, provides coverage to a qualified
individual (as defined in subsection (b)), the plan or issuer--
(A) may not deny the individual participation in the clinical trial
referred to in subsection (b)(2);
(B) subject to subsection (c), may not deny (or limit or impose additional
conditions on) the coverage of routine patient costs for items and services
furnished in connection with participation in the trial; and
(C) may not discriminate against the individual on the basis of the
enrollee's participation in such trial.
(2) EXCLUSION OF CERTAIN COSTS- For purposes of paragraph (1)(B), routine
patient costs do not include the cost of the tests or measurements conducted
primarily for the purpose of the clinical trial involved.
(3) USE OF IN-NETWORK PROVIDERS- If one or more participating providers
is participating in a clinical trial, nothing in paragraph (1) shall be
construed as preventing a plan or issuer from requiring that a qualified
individual participate in the trial through such a participating provider
if the provider will accept the individual as a participant in the trial.
(b) Qualified Individual Defined- For purposes of subsection (a), the term
`qualified individual' means an individual who is a participant or beneficiary
in a group health plan, or who is an enrollee under health insurance coverage,
and who meets the following conditions:
(1)(A) The individual has a life-threatening or serious illness for which
no standard treatment is effective.
(B) The individual is eligible to participate in an approved clinical
trial according to the trial protocol with respect to treatment of such
illness.
(C) The individual's participation in the trial offers meaningful potential
for significant clinical benefit for the individual.
(A) the referring physician is a participating health care professional
and has concluded that the individual's participation in such trial
would be appropriate based upon the individual meeting the conditions
described in paragraph (1); or
(B) the participant, beneficiary, or enrollee provides medical and scientific
information establishing that the individual's participation in such
trial would be appropriate based upon the individual meeting the conditions
described in paragraph (1).
(1) IN GENERAL- Under this section a group health plan or health insurance
issuer shall provide for payment for routine patient costs described in
subsection (a)(2) but is not required to pay for costs of items and services
that are reasonably expected (as determined by the Secretary) to be paid
for by the sponsors of an approved clinical trial.
(2) PAYMENT RATE- In the case of covered items and services provided by--
(A) a participating provider, the payment rate shall be at the agreed
upon rate, or
(B) a nonparticipating provider, the payment rate shall be at the rate
the plan or issuer would normally pay for comparable services under
subparagraph (A).
(d) Approved Clinical Trial Defined-
(1) IN GENERAL- In this section, the term `approved clinical trial' means
a clinical research study or clinical investigation approved and funded
(which may include funding through in-kind contributions) by one or more
of the following:
(A) The National Institutes of Health.
(B) A cooperative group or center of the National Institutes of Health.
(C) Either of the following if the conditions described in paragraph
(2) are met:
(i) The Department of Veterans Affairs.
(ii) The Department of Defense.
(2) CONDITIONS FOR DEPARTMENTS- The conditions described in this paragraph,
for a study or investigation conducted by a Department, are that the study
or investigation has been reviewed and approved through a system of peer
review that the Secretary determines--
(A) to be comparable to the system of peer review of studies and investigations
used by the National Institutes of Health, and
(B) assures unbiased review of the highest scientific standards by qualified
individuals who have no interest in the outcome of the review.
(e) Construction- Nothing in this section shall be construed to limit a
plan's or issuer's coverage with respect to clinical trials.
Subtitle C--Access to Information
SEC. 121. PATIENT ACCESS TO INFORMATION.
(a) Disclosure Requirement-
(1) GROUP HEALTH PLANS- A group health plan shall--
(A) provide to participants and beneficiaries at the time of initial
coverage under the plan (or the effective date of this section, in the
case of individuals who are participants or beneficiaries as of such
date), and at least annually thereafter, the information described in
subsection (b) in printed form;
(B) provide to participants and beneficiaries, within a reasonable period
(as specified by the appropriate Secretary) before or after the date
of significant changes in the information described in subsection (b),
information in printed form on such significant changes; and
(C) upon request, make available to participants and beneficiaries,
the applicable authority, and prospective participants and beneficiaries,
the information described in subsection (b) or (c) in printed form.
(2) HEALTH INSURANCE ISSUERS- A health insurance issuer in connection
with the provision of health insurance coverage shall--
(A) provide to individuals enrolled under such coverage at the time
of enrollment, and at least annually thereafter, the information described
in subsection (b) in printed form;
(B) provide to enrollees, within a reasonable period (as specified by
the appropriate Secretary) before or after the date of significant changes
in the information described in subsection (b), information in printed
form on such significant changes; and
(C) upon request, make available to the applicable authority, to individuals
who are prospective enrollees, and to the public the information described
in subsection (b) or (c) in printed form.
(b) Information Provided- The information described in this subsection with
respect to a group health plan or health insurance coverage offered by a
health insurance issuer includes the following:
(1) SERVICE AREA- The service area of the plan or issuer.
(2) BENEFITS- Benefits offered under the plan or coverage, including--
(A) covered benefits, including benefit limits and coverage exclusions;
(B) cost sharing, such as deductibles, coinsurance, and copayment amounts,
including any liability for balance billing, any maximum limitations
on out of pocket expenses, and the maximum out of pocket costs for services
that are provided by nonparticipating providers or that are furnished
without meeting the applicable utilization review requirements;
(C) the extent to which benefits may be obtained from nonparticipating
providers;
(D) the extent to which a participant, beneficiary, or enrollee may
select from among participating providers and the types of providers
participating in the plan or issuer network;
(E) process for determining experimental coverage; and
(F) use of a prescription drug formulary.
(3) ACCESS- A description of the following:
(A) The number, mix, and distribution of providers under the plan or
coverage.
(B) Out-of-network coverage (if any) provided by the plan or coverage.
(C) Any point-of-service option (including any supplemental premium
or cost-sharing for such option).
(D) The procedures for participants, beneficiaries, and enrollees to
select, access, and change participating primary and specialty providers.
(E) The rights and procedures for obtaining referrals (including standing
referrals) to participating and nonparticipating providers.
(F) The name, address, and telephone number of participating health
care providers and an indication of whether each such provider is available
to accept new patients.
(G) Any limitations imposed on the selection of qualifying participating
health care providers, including any limitations imposed under section
112(b)(2).
(H) How the plan or issuer addresses the needs of participants, beneficiaries,
and enrollees and others who do not speak English or who have other
special communications needs in accessing providers under the plan or
coverage, including the provision of information described in this subsection
and subsection (c) to such individuals.
(4) OUT-OF-AREA COVERAGE- Out-of-area coverage provided by the plan or
issuer.
(5) EMERGENCY COVERAGE- Coverage of emergency services, including--
(A) the appropriate use of emergency services, including use of the
911 telephone system or its local equivalent in emergency situations
and an explanation of what constitutes an emergency situation;
(B) the process and procedures of the plan or issuer for obtaining emergency
services; and
(C) the locations of (i) emergency departments, and (ii) other settings,
in which plan physicians and hospitals provide emergency services and
post-stabilization care.
(6) PERCENTAGE OF PREMIUMS USED FOR BENEFITS (LOSS-RATIOS)- In the case
of health insurance coverage only (and not with respect to group health
plans that do not provide coverage through health insurance coverage),
a description of the overall loss-ratio for the coverage (as defined in
accordance with rules established or recognized by the Secretary of Health
and Human Services).
(7) PRIOR AUTHORIZATION RULES- Rules regarding prior authorization or
other review requirements that could result in noncoverage or nonpayment.
(8) GRIEVANCE AND APPEALS PROCEDURES- All appeal or grievance rights and
procedures under the plan or coverage, including the method for filing
grievances and the time frames and circumstances for acting on grievances
and appeals, who is the applicable authority with respect to the plan
or issuer.
(9) QUALITY ASSURANCE- Any information made public by an accrediting organization
in the process of accreditation of the plan or issuer or any additional
quality indicators the plan or issuer makes available.
(10) INFORMATION ON ISSUER- Notice of appropriate mailing addresses and
telephone numbers to be used by participants, beneficiaries, and enrollees
in seeking information or authorization for treatment.
(11) NOTICE OF REQUIREMENTS- Notice of the requirements of this title.
(12) AVAILABILITY OF INFORMATION ON REQUEST- Notice that the information
described in subsection (c) is available upon request.
(c) Information Made Available Upon Request- The information described in
this subsection is the following:
(1) UTILIZATION REVIEW ACTIVITIES- A description of procedures used and
requirements (including circumstances, time frames, and appeal rights)
under any utilization review program under section 101, including under
any drug formulary program under section 118.
(2) GRIEVANCE AND APPEALS INFORMATION- Information on the number of grievances
and appeals and on the disposition in the aggregate of such matters.
(3) METHOD OF PHYSICIAN COMPENSATION- A general description by category
(including salary, fee-for-service, capitation, and such other categories
as may be specified in regulations of the Secretary) of the applicable
method by which a specified prospective or treating health care professional
is (or would be) compensated in connection with the provision of health
care under the plan or coverage.
(4) SPECIFIC INFORMATION ON CREDENTIALS OF PARTICIPATING PROVIDERS- In
the case of each participating provider, a description of the credentials
of the provider.
(5) FORMULARY RESTRICTIONS- A description of the nature of any drug formula
restrictions.
(6) PARTICIPATING PROVIDER LIST- A list of current participating health
care providers.
(d) Construction- Nothing in this section shall be construed as requiring
public disclosure of individual contracts or financial arrangements between
a group health plan or health insurance issuer and any provider.
Subtitle D--Protecting the Doctor-Patient Relationship
SEC. 131. PROHIBITION OF INTERFERENCE WITH CERTAIN MEDICAL COMMUNICATIONS.
(a) General Rule- The provisions of any contract or agreement, or the operation
of any contract or agreement, between a group health plan or health insurance
issuer in relation to health insurance coverage (including any partnership,
association, or other organization that enters into or administers such
a contract or agreement) and a health care provider (or group of health
care providers) shall not prohibit or otherwise restrict a health care professional
from advising such a participant, beneficiary, or enrollee who is a patient
of the professional about the health status of the individual or medical
care or treatment for the individual's condition or disease, regardless
of whether benefits for such care or treatment are provided under the plan
or coverage, if the professional is acting within the lawful scope of practice.
(b) Nullification- Any contract provision or agreement that restricts or
prohibits medical communications in violation of subsection (a) shall be
null and void.
SEC. 132. PROHIBITION OF DISCRIMINATION AGAINST PROVIDERS BASED ON LICENSURE.
(a) In General- A group health plan and a health insurance issuer offering
health insurance coverage shall not discriminate with respect to participation
or indemnification as to any provider who is acting within the scope of
the provider's license or certification under applicable State law, solely
on the basis of such license or certification.
(b) Construction- Subsection (a) shall not be construed--
(1) as requiring the coverage under a group health plan or health insurance
coverage of particular benefits or services or to prohibit a plan or issuer
from including providers only to the extent necessary to meet the needs
of the plan's or issuer's participants, beneficiaries, or enrollees or
from establishing any measure designed to maintain quality and control
costs consistent with the responsibilities of the plan or issuer;
(2) to override any State licensure or scope-of-practice law; or
(3) as requiring a plan or issuer that offers network coverage to include
for participation every willing provider who meets the terms and conditions
of the plan or issuer.
SEC. 133. PROHIBITION AGAINST IMPROPER INCENTIVE ARRANGEMENTS.
(a) In General- A group health plan and a health insurance issuer offering
health insurance coverage may not operate any physician incentive plan (as
defined in subparagraph (B) of section 1876(i)(8) of the Social Security
Act) unless the requirements described in clauses (i), (ii)(I), and (iii)
of subparagraph (A) of such section are met with respect to such a plan.
(b) Application- For purposes of carrying out paragraph (1), any reference
in section 1876(i)(8) of the Social Security Act to the Secretary, an eligible
organization, or an individual enrolled with the organization shall be treated
as a reference to the applicable authority, a group health plan or health
insurance issuer, respectively, and a participant, beneficiary, or enrollee
with the plan or organization, respectively.
(c) Construction- Nothing in this section shall be construed as prohibiting
all capitation and similar arrangements or all provider discount arrangements.
SEC. 134. PAYMENT OF CLAIMS.
A group health plan, and a health insurance issuer offering group health
insu
