[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 6 Introduced in Senate (IS)]
107th CONGRESS
1st Session
S. 6
To amend the Public Health Service Act, the Employee Retirement Income
Security Act of 1974, and the Internal Revenue Code of 1986 to protect
consumers in managed care plans and other health coverage.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
January 22, 2001
Mr. Daschle (for himself, Mr. Kennedy, Mr. Akaka, Mr. Biden, Mr.
Bingaman, Mrs. Boxer, Mr. Byrd, Mrs. Carnahan, Mr. Carper, Mr. Cleland,
Mrs. Clinton, Mr. Conrad, Mr. Corzine, Mr. Dayton, Mr. Dodd, Mr.
Dorgan, Mr. Durbin, Mr. Edwards, Mr. Graham, Mr. Harkin, Mr. Hollings,
Mr. Inouye, Mr. Johnson, Mr. Kerry, Ms. Landrieu, Mr. Leahy, Mr. Levin,
Ms. Mikulski, Mrs. Murray, Mr. Nelson of Florida, Mr. Reed, Mr. Reid,
Mr. Rockefeller, Mr. Sarbanes, Mr. Schumer, Ms. Stabenow, Mr.
Torricelli, Mr. Wellstone, and Mr. Wyden) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act, the Employee Retirement Income
Security Act of 1974, 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 ``Patients' Bill of
Rights Act''.
(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. 151. Definitions.
Sec. 152. Preemption; State flexibility; construction.
Sec. 153. Exclusions.
Sec. 154. Coverage of limited scope plans.
Sec. 155. Regulations.
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.
Sec. 303. Limitations on actions.
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--MISCELLANEOUS PROVISIONS
Sec. 601. Health care paperwork simplification.
Sec. 602. No impact on social security trust fund.
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).
(B) Deadline.--
(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 five 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.
(2) Ongoing care.--
(A) Concurrent review.--
(i) In general.--Subject to subparagraph
(B), in the case of a concurrent review of
ongoing care (including hospitalization), which
results in a termination or reduction of such
care, the plan must provide by telephone and in
printed 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, 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.
(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 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.--
(1) Conduct of review.--
(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.
(B) Deadline.--
(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 five 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 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.--
(i) In general.--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.
(ii) Limitation on ability to influence
selection.--No selection process established by
the applicable authority under this subsection
shall provide the participant, beneficiary, or
enrollee or the plan or issuer with the ability
to determine or influence the selection of a
qualified external appeal entity to review the
appeal of the participant, beneficiary, or
enrollee.
(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 to 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.
(D) Evidence.--
(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 three 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).
(D) Requirement of sufficient number of certified
entities.--The appropriate Secretary shall certify and
recertify a sufficient number of external appeal
entities under this paragraph to ensure the timely and
efficient provision of external review services.
(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) with respect to--
(I) a group health plan or health
insurance coverage offered in
connection with such a plan, the plan
or the health insurance issuer offering
such coverage; or
(II) individual health insurance
coverage, the health insurance issuer
offering such coverage,
or any plan sponsor, fiduciary, officer,
director, or management employee of such plan
or issuer;
(ii) the health care professional that
provided the health care involved in the
coverage decision;
(iii) the institution at which the health
care involved in the coverage decision is
provided;
(iv) the manufacturer of any drug or other
item that was included in the health care
involved in the coverage decision; or
(v) any other party determined under any
regulations which the Secretary may prescribe
to have a substantial interest in the coverage
decision.
(4) Limitation on liability of reviewers.--No qualified
external appeal entity having a contract with a plan or issuer
under this part and no person who is employed by any such
entity or who furnishes professional services to such entity,
shall be held by reason of the performance of any duty,
function, or activity required or authorized pursuant to this section,
to have violated any criminal law, or to be civilly liable under any
law of the United States or of any State (or political subdivision
thereof) if due care was exercised in the performance of such duty,
function, or activity and there was no actual malice or gross
misconduct in the performance of such duty, function, or activity.
(d) External Appeal Determination Binding on Plan.--The
determination by an external appeal entity under this section is
binding on the plan and issuer involved in the determination.
(e) Penalties Against Authorized Officials for Refusing To
Authorize the Determination of an External Review Entity.--
(1) Monetary penalties.--In any case in which the
determination of an external review entity is not followed by a
group health plan, or by a health insurance issuer offering
health insurance coverage, any person who, acting in the
capacity of authorizing the benefit, causes such refusal may,
in the discretion in a court of competent jurisdiction, be
liable to an aggrieved participant, beneficiary, or enrollee
for a civil penalty in an amount of up to $1,000 a day from the
date on which the determination was transmitted to the plan or
issuer by the external review entity until the date the refusal
to provide the benefit is corrected.
(2) Cease and desist order and order of attorney's fees.--
In any action described in paragraph (1) brought by a
participant, beneficiary, or enrollee with respect to a group
health plan, or a health insurance issuer offering health insurance
coverage, in which a plaintiff alleges that a person referred to in
such paragraph has taken an action 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
(ii) $500,000.
(4) Removal and disqualification.--Any person acting in the
capacity of authorizing benefits who has engaged in any such
pattern or practice described in paragraph (3)(A) with respect
to a plan or coverage, upon the petition of the appropriate
Secretary, may be removed by the court from such position, and
from any other involvement, with respect to such a plan or
coverage, and may be precluded from returning to any such
position or involvement for a period determined by the court.
(f) Protection of Legal Rights.--Nothing in this subtitle shall be
construed as altering or eliminating any cause of action or legal
rights or remedies of participants, beneficiaries, enrollees, and
others under State or Federal law (including sections 502 and 503 of
the Employee Retirement Income Security Act of 1974), including the
right to file judicial actions to enforce rights.
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 three 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--
(1) a health insurance issuer providing health insurance
coverage in connection with a group health plan offers to
enrollees health insurance coverage 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, or
(2) a group health plan offers to participants or
beneficiaries health benefits which provide 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 plan to provide such services,
then the issuer or plan shall also offer or arrange to be offered to
such enrollees, participants, or beneficiaries (at the time of
enrollment and during an annual open season as provided under
subsection (c)) the option of health insurance coverage or health
benefits which provide for coverage of such services which are not
furnished through health care professionals and providers who are
members of such a network unless such enrollees, participants, or
beneficiaries 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 or group health plan 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, participant, or
beneficiary unless it is paid by the health plan sponsor or group
health plan through agreement with the health insurance issuer.
(c) Open Season.--An enrollee, participant, or beneficiary, may
change to the offering provided under this section only during a time
period determined by the health insurance issuer or group health plan.
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.
(b) Specialists.--
(1) In general.--Subject to paragraph (2), a group health
plan and a health insurance issuer that offers health insurance
coverage shall permit each participant, beneficiary, or
enrollee to receive medically necessary or appropriate
specialty care, pursuant to appropriate referral procedures,
from any qualified participating health care professional who
is available to accept such individual for such care.
(2) Limitation.--Paragraph (1) shall not apply to specialty
care if the plan or issuer clearly informs participants,
beneficiaries, and enrollees of the limitations on choice of
participating health care professionals with respect to such
care.
(3) Construction.--Nothing in this subsection shall be
construed as affecting the application of section 114 (relating
to access to specialty 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.--In the case of services (other than emergency services) for
which benefits are available under a group health plan, or under health
insurance coverage offered by a health insurance issuer, 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 the guidelines
established under section 1852(d)(2) of the Social Security Act), if
the services are maintenance care or post-stabilization care covered
under such guidelines.
SEC. 114. ACCESS TO SPECIALTY CARE.
(a) Specialty Care for Covered Services.--
(1) In general.--If--
(A) an individual is a participant or beneficiary
under a group health plan or an enrollee who is covered
under health insurance coverage offered by a health
insurance issuer;
(B) the individual has a condition or disease of
sufficient seriousness and complexity to require
treatment by a specialist; and
(C) benefits for such treatment are provided under
the plan or coverage,
the plan or issuer shall make or provide for a referral to a
specialist who is available and accessible to provide the
treatment for such condition or disease.
(2) Specialist defined.--For purposes of this subsection,
the term ``specialist'' means, with respect to a condition, a
health care practitioner, facility, or center that has adequate
expertise through appropriate training and experience
(including, in the case of a child, appropriate pediatric
expertise) to provide high quality care in treating the
condition.
(3) Care under referral.--A group health plan or health
insurance issuer may require that the care provided to an
individual pursuant to such referral under paragraph (1) be--
(A) pursuant to a treatment plan, only if the
treatment plan is developed by the specialist and
approved by the plan or issuer, in consultation with
the designated primary care provider or specialist and
the individual (or the individual's designee); and
(B) in accordance with applicable quality assurance
and utilization review standards of the plan or issuer.
Nothing in this subsection shall be construed as preventing
such a treatment plan for an individual from requiring a
specialist to provide the primary care provider with regular
updates on the specialty care provided, as well as all
necessary medical information.
(4) Referrals to participating providers.--A group health
plan or health insurance issuer is not required under paragraph
(1) to provide for a referral to a specialist that is not a
participating provider, unless the plan or issuer does not have
an appropriate specialist that is available and accessible to
treat the individual's condition and that is a participating
provider with respect to such treatment.
(5) Treatment of nonparticipating providers.--If a plan or
issuer refers an individual to a nonparticipating specialist
pursuant to paragraph (1), services provided pursuant to the
approved treatment plan (if any) shall be provided at no
additional cost to the individual beyond what the individual
would otherwise pay for services received by such a specialist
that is a participating provider.
(b) Specialists as Gatekeeper for Treatment of Ongoing Special
Conditions.--
(1) In general.--A group health plan, or a health insurance
issuer, in connection with the provision of health insurance
coverage, shall have a procedure by which an individual who is
a participant, beneficiary, or enrollee and who has an ongoing
special condition (as defined in paragraph (3)) may request and
receive a referral to a specialist for such condition who shall
be responsible for and capable of providing and coordinating
the individual's care with respect to the condition. Under such
procedures if such an individual's care would most
appropriately be coordinated by such a specialist, such plan or
issuer shall refer the individual to such specialist.
(2) Treatment for related referrals.--Such specialists
shall be permitted to treat the individual without a referral
from the individual's primary care provider and may authorize
such referrals, procedures, tests, and other medical services
as the individual's primary care provider would otherwise be
permitted to provide or authorize, subject to the terms of the
treatment (referred to in subsection (a)(3)(A)) with respect to
the ongoing special condition.
(3) Ongoing special condition defined.--In this subsection,
the term ``ongoing special condition'' means a condition or
disease that--
(A) is life-threatening, degenerative, or
disabling; and
(B) requires specialized medical care over a
prolonged period of time.
(4) Terms of referral.--The provisions of paragraphs (3)
through (5) of subsection (a) apply with respect to referrals
under paragraph (1) of this subsection in the same manner as
they apply to referrals under subsection (a)(1).
(c) Standing Referrals.--
(1) In general.--A group health plan, and a health
insurance issuer in connection with the provision of health
insurance coverage, shall have a procedure by which an
individual who is a participant, beneficiary, or enrollee and
who has a condition that requires ongoing care from a
specialist may receive a standing referral to such specialist
for treatment of such condition. If the plan or issuer, or if
the primary care provider in consultation with the medical
director of the plan or issuer and the specialist (if any),
determines that such a standing referral is appropriate, the
plan or issuer shall make such a referral to such a specialist
if the individual so desires.
(2) Terms of referral.--The provisions of paragraphs (3)
through (5) of subsection (a) apply with respect to referrals
under paragraph (1) of this subsection in the same manner as
they apply to referrals under subsection (a)(1).
SEC. 115. ACCESS TO OBSTETRICAL AND 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.
(a) In General.--
(1) Termination of provider.--If a contract between a group
health plan, or a health insurance issuer in connection with
the provision of health insurance coverage, and a health care
provider is terminated (as defined in paragraph (3)(B)), or
benefits or coverage provided by a health care provider are
terminated because of a change in the terms of provider
participation in a group health plan, and an individual who is
a participant, beneficiary, or enrollee in the plan or coverage
is undergoing treatment from the provider for an ongoing
special condition (as defined in paragraph (3)(A)) at the time
of such termination, the plan or issuer shall--
(A) notify the individual on a timely basis of such
termination and of the right to elect continuation of
coverage of treatment by the provider under this
section; and
(B) subject to subsection (c), permit the
individual to elect to continue to be covered with
respect to treatment by the provider of such condition
during a transitional period (provided under subsection
(b)).
(2) Treatment of termination of contract with health
insurance issuer.--If a contract for the provision of health
insurance coverage between a group health plan and a health
insurance issuer is terminated and, as a result of such
termination, coverage of services of a health care provider is
terminated with respect to an individual, the provisions of
paragraph (1) (and the succeeding provisions of this section)
shall apply under the plan in the same manner as if there had
been a contract between the plan and the provider that had been
terminated, but only with respect to benefits that are covered
under the plan after the contract termination.
(3) Definitions.--For purposes of this section:
(A) Ongoing special condition.--The term ``ongoing
special condition'' has the meaning given such term in
section 114(b)(3), and also includes pregnancy.
(B) Termination.--The term ``terminated'' includes,
with respect to a contract, the expiration or
nonrenewal of the contract, but does not include a
termination of the contract by the plan or issuer for failure to meet
applicable quality standards or for fraud.
(b) Transitional Period.--
(1) In general.--Except as provided in paragraphs (2)
through (4), the transitional period under this subsection
shall extend up to 90 days (as determined by the treating
health care professional) after the date of the notice
described in subsection (a)(1)(A) of the provider's
termination.
(2) Scheduled surgery and organ transplantation.--If
surgery or organ transplantation was scheduled for an
individual before the date of the announcement of the
termination of the provider status under subsection (a)(1)(A)
or if the individual on such date was on an established waiting list or
otherwise scheduled to have such surgery or transplantation, the
transitional period under this subsection with respect to the surgery
or transplantation shall extend beyond the period under paragraph (1)
and until the date of discharge of the individual after completion of
the surgery or transplantation.
(3) Pregnancy.--If--
(A) a participant, beneficiary, or enrollee was
determined to be pregnant at the time of a provider's
termination of participation; and
(B) the provider was treating the pregnancy before
date of the termination,
the transitional period under this subsection with respect to
provider's treatment of the pregnancy shall extend through the
provision of post-partum care directly related to the delivery.
(4) Terminal illness.--If--
(A) a participant, beneficiary, or enrollee was
determined to be terminally ill (as determined under
section 1861(dd)(3)(A) of the Social Security Act) at
the time of a provider's termination of participation;
and
(B) the provider was treating the terminal illness
before the date of termination,
the transitional period under this subsection shall extend for
the remainder of the individual's life for care directly
related to the treatment of the terminal illness or its medical
manifestations.
(c) Permissible Terms and Conditions.--A group health plan or
health insurance issuer may condition coverage of continued treatment
by a provider under subsection (a)(1)(B) upon the individual notifying
the plan of the election of continued coverage and upon the provider
agreeing to the following terms and conditions:
(1) The provider agrees to accept reimbursement from the
plan or issuer and individual involved (with respect to cost-
sharing) at the rates applicable prior to the start of the
transitional period as payment in full (or, in the case
described in subsection (a)(2), at the rates applicable under
the replacement plan or issuer after the date of the
termination of the contract with the health insurance issuer)
and not to impose cost-sharing with respect to the individual
in an amount that would exceed the cost-sharing that could have
been imposed if the contract referred to in subsection (a)(1)
had not been terminated.
(2) The provider agrees to adhere to the quality assurance
standards of the plan or issuer responsible for payment under
paragraph (1) and to provide to such plan or issuer necessary
medical information related to the care provided.
(3) The provider agrees otherwise to adhere to such plan's
or issuer's policies and procedures, including procedures
regarding referrals and obtaining prior authorization and
providing services pursuant to a treatment plan (if any)
approved by the plan or issuer.
(d) Construction.--Nothing in this section shall be construed to
require the coverage of benefits which would not have been covered if
the provider involved remained a participating provider.
SEC. 118. ACCESS TO NEEDED PRESCRIPTION DRUGS.
(a) In General.--To the extent that a group health plan, or health
insurance coverage offered by a health insurance issuer, provides
coverage for benefits with respect to prescription drugs, and limits
such coverage to drugs included in a formulary, the plan or issuer
shall--
(1) ensure the participation of physicians and pharmacists
in developing and reviewing such formulary;
(2) provide for disclosure of the formulary to providers;
and
(3) in accordance with the applicable quality assurance and
utilization review standards of the plan or issuer, provide for
exceptions from the formulary limitation when a non-formulary
alternative is medically necessary and appropriate and, in the
case of such an exception, apply the same cost-sharing
requirements that would have applied in the case of a drug
covered under the formulary.
(b) Coverage of Approved Drugs and Medical Devices.--
(1) In general.--A group health plan (or health insurance
coverage offered in connection with such a plan) that provides
any coverage of prescription drugs or medical devices shall not
deny coverage of such a drug or device on the basis that the
use is investigational, if the use--
(A) in the case of a prescription drug--
(i) is included in the labeling authorized
by the application in effect for the drug
pursuant to subsection (b) or (j) of section
505 of the Federal Food, Drug, and Cosmetic
Act, without regard to any postmarketing
requirements that may apply under such Act; or
(ii) is included in the labeling authorized
by the application in effect for the drug under
section 351 of the Public Health Service Act,
without regard to any postmarketing
requirements that may apply pursuant to such
section; or
(B) in the case of a medical device, is included in
the labeling authorized by a regulation under
subsection (d) or (3) of section 513 of the Federal
Food, Drug, and Cosmetic Act, an order under subsection
(f) of such section, or an application approved under
section 515 of such Act, without regard to any
postmarketing requirements that may apply under such
Act.
(2) Construction.--Nothing in this subsection shall be
construed as requiring a group health plan (or health insurance
coverage offered in connection with such a plan) to provide any
coverage of prescription drugs or medical devices.
SEC. 119. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CLINICAL
TRIALS.
(a) Coverage.--
(1) In general.--If a group health plan, or health
insurance issuer that is providing health insurance coverage,
provides coverage to a qualified individual (as defined in
subsection (b)), the plan or issuer--
(A) may not deny the individual participation in
the clinical trial referred to in subsection (b)(2);
(B) subject to subsection (c), may not deny (or
limit or impose additional conditions on) the coverage
of routine patient costs for items and services
furnished in connection with participation in the
trial; and
(C) may not discriminate against the individual on
the basis of the enrollee's participation in such
trial.
(2) Exclusion of certain costs.--For purposes of paragraph
(1)(B), routine patient costs do not include the cost of the
tests or measurements conducted primarily for the purpose of
the clinical trial involved.
(3) Use of in-network providers.--If one or more
participating providers is participating in a clinical trial,
nothing in paragraph (1) shall be construed as preventing a plan or
issuer from requiring that a qualified individual participate in the
trial through such a participating provider if the provider will accept
the individual as a participant in the trial.
(b) Qualified Individual Defined.--For purposes of subsection (a),
the term ``qualified individual'' means an individual who is a
participant or beneficiary in a group health plan, or who is an
enrollee under health insurance coverage, and who meets the following
conditions:
(1)(A) The individual has a life-threatening or serious
illness for which no standard treatment is effective.
(B) The individual is eligible to participate in an
approved clinical trial according to the trial protocol with
respect to treatment of such illness.
(C) The individual's participation in the trial offers
meaningful potential for significant clinical benefit for the
individual.
(2) Either--
(A) the referring physician is a participating
health care professional and has concluded that the
individual's participation in such trial would be
appropriate based upon the individual meeting the
conditions described in paragraph (1); or
(B) the participant, beneficiary, or enrollee
provides medical and scientific information
establishing that the individual's participation in
such trial would be appropriate based upon the
individual meeting the conditions described in
paragraph (1).
(c) Payment.--
(1) In general.--Under this section a group health plan or
health insurance issuer shall provide for payment for routine
patient costs described in subsection (a)(2) but is not
required to pay for costs of items and services that are
reasonably expected (as determined by the Secretary) to be paid
for by the sponsors of an approved clinical trial.
(2) Payment rate.--In the case of covered items and
services provided by--
(A) a participating provider, the payment rate
shall be at the agreed upon rate; or
(B) a nonparticipating provider, the payment rate
shall be at the rate the plan or issuer would normally
pay for comparable services under subparagraph (A).
(d) Approved Clinical Trial Defined.--
(1) In general.--In this section, the term ``approved
clinical trial'' means a clinical research study or clinical
investigation approved and funded (which may include funding
through in-kind contributions) by one or more of the following:
(A) The National Institutes of Health.
(B) A cooperative group or center of the National
Institutes of Health.
(C) Either of the following if the conditions
described in paragraph (2) are met:
(i) The Department of Veterans Affairs.
(ii) The Department of Defense.
(2) Conditions for departments.--The conditions described
in this paragraph, for a study or investigation conducted by a
Department, are that the study or investigation has been
reviewed and approved through a system of peer review that the
Secretary determines--
(A) to be comparable to the system of peer review
of studies and investigations used by the National
Institutes of Health; and
(B) assures unbiased review of the highest
scientific standards by qualified individuals who have
no interest in the outcome of the review.
(e) Construction.--Nothing in this section shall be construed to
limit a plan's or issuer's coverage with respect to clinical trials.
Subtitle C--Access to Information
SEC. 121. PATIENT ACCESS TO INFORMATION.
(a) Disclosure Requirement.--
(1) Group health plans.--A group health plan shall--
(A) provide to participants and beneficiaries at
the time of initial coverage under the plan (or the
effective date of this section, in the case of
individuals who are participants or beneficiaries as of
such date), and at least annually thereafter, the
information described in subsection (b) in printed
form;
(B) provide to participants and beneficiaries,
within a reasonable period (as specified by the
appropriate Secretary) before or after the date of
significant changes in the information described in
subsection (b), information in printed form on such
significant changes; and
(C) upon request, make available to participants
and beneficiaries, the applicable authority, and
prospective participants and beneficiaries, the
information described in subsection (b) or (c) in
printed form.
(2) Health insurance issuers.--A health insurance issuer in
connection with the provision of health insurance coverage
shall--
(A) provide to individuals enrolled under such
coverage at the time of enrollment, and at least
annually thereafter, the information described in
subsection (b) in printed form;
(B) provide to enrollees, within a reasonable
period (as specified by the appropriate Secretary)
before or after the date of significant changes in the
information described in subsection (b), information in
printed form on such significant changes; and
(C) upon request, make available to the applicable
authority, to individuals who are prospective
enrollees, and to the public the information described
in subsection (b) or (c) in printed form.
(b) Information Provided.--The information described in this
subsection with respect to a group health plan or health insurance
coverage offered by a health insurance issuer includes the following:
(1) Service area.--The service area of the plan or issuer.
(2) Benefits.--Benefits offered under the plan or coverage,
including--
(A) covered benefits, including benefit limits and
coverage exclusions;
(B) cost sharing, such as deductibles, coinsurance,
and copayment amounts, including any liability for
balance billing, any maximum limitations on out of
pocket expenses, and the maximum out of pocket costs
for services that are provided by nonparticipating
providers or that are furnished without meeting the
applicable utilization review requirements;
(C) the extent to which benefits may be obtained
from nonparticipating providers;
(D) the extent to which a participant, beneficiary,
or enrollee may select from among participating
providers and the types of providers participating in
the plan or issuer network;
(E) process for determining experimental coverage;
and
(F) use of a prescription drug formulary.
(3) Access.--A description of the following:
(A) The number, mix, and distribution of providers
under the plan or coverage.
(B) Out-of-network coverage (if any) provided by
the plan or coverage.
(C) Any point-of-service option (including any
supplemental premium or cost-sharing for such option).
(D) The procedures for participants, beneficiaries,
and enrollees to select, access, and change
participating primary and specialty providers.
(E) The rights and procedures for obtaining
referrals (including standing referrals) to
participating and nonparticipating providers.
(F) The name, address, and telephone number of
participating health care providers and an indication
of whether each such provider is available to accept
new patients.
(G) Any limitations imposed on the selection of
qualifying participating health care providers,
including any limitations imposed under section
112(b)(2).
(H) How the plan or issuer addresses the needs of
participants, beneficiaries, and enrollees and others
who do not speak English or who have other special
communications needs in accessing providers under the plan or coverage,
including the provision of information described in this subsection and
subsection (c) to such individuals.
(4) Out-of-area coverage.--Out-of-area coverage provided by
the plan or issuer.
(5) Emergency coverage.--Coverage of emergency services,
including--
(A) the appropriate use of emergency services,
including use of the 911 telephone system or its local
equivalent in emergency situations and an explanation
of what constitutes an emergency situation;
(B) the process and procedures of the plan or
issuer for obtaining emergency services; and
(C) the locations of (i) emergency departments, and
(ii) other settings, in which plan physicians and
hospitals provide emergency services and post-
stabilization care.
(6) Percentage of premiums used for benefits (loss-
ratios).--In the case of health insurance coverage only (and
not with respect to group health plans that do not provide
coverage through health insurance coverage), a description of
the overall loss-ratio for the coverage (as defined in
accordance with rules established or recognized by the
Secretary of Health and Human Services).
(7) Prior authorization rules.--Rules regarding prior
authorization or other review requirements that could result in
noncoverage or nonpayment.
(8) Grievance and appeals procedures.--All appeal or
grievance rights and procedures under the plan or coverage,
including the method for filing grievances and the time frames
and circumstances for acting on grievances and appeals, who is
the applicable authority with respect to the plan or issuer.
(9) Quality assurance.--Any information made public by an
accrediting organization in the process of accreditation of the
plan or issuer or any additional quality indicators the plan or
issuer makes available.
(10) Information on issuer.--Notice of appropriate mailing
addresses and telephone numbers to be used by participants,
beneficiaries, and enrollees in seeking information or
authorization for treatment.
(11) Notice of requirements.--Notice of the requirements of
this title.
(12) Availability of information on request.--Notice that
the information described in subsection (c) is available upon
request.
(c) Information Made Available Upon Request.--The information
described in this subsection is the following:
(1) Utilization review activities.--A description of
procedures used and requirements (including circumstances, time
frames, and appeal rights) under any utilization review program
under section 101, including under any drug formulary program
under section 118.
(2) Grievance and appeals information.--Information on the
number of grievances and appeals and on the disposition in the
aggregate of such matters.
(3) Method of physician compensation.--A general
description by category (including salary, fee-for-service,
capitation, and such other categories as may be specified in
regulations of the Secretary) of the applicable method by which
a specified prospective or treating health care professional is
(or would be) compensated in connection with the provision of
health care under the plan or coverage.
(4) Specific information on credentials of participating
providers.--In the case of each participating provider, a
description of the credentials of the provider.
(5) Formulary restrictions.--A description of the nature of
any drug formula restrictions.
(6) Participating provider list.--A list of current
participating health care providers.
(d) Construction.--Nothing in this section shall be construed as
requiring public disclosure of individual contracts or financial
arrangements between a group health plan or health insurance issuer and
any provider.
Subtitle D--Protecting the Doctor-Patient Relationship
SEC. 131. PROHIBITION OF INTERFERENCE WITH CERTAIN MEDICAL
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 insurance coverage, shall provide for prompt payment of claims
submitted for health care services or supplies furnished to a
participant, beneficiary, or enrollee with respect to benefits covered
by the plan or issuer, in a manner consistent with the provisions of
sections 1816(c)(2) and 1842(c)(2) of the Social Security Act (42
U.S.C. 1395h(c)(2) and 42 U.S.C. 1395u(c)(2)), except that for purposes
of this section, subparagraph (C) of section 1816(c)(2) of the Social
Security Act shall be treated as applying to claims received from a
participant, beneficiary, or enrollee as well as claims referred to in
such subparagraph.
SEC. 135. PROTECTION FOR PATIENT ADVOCACY.
(a) Protection for Use of Utilization Review and Grievance
Process.--A group health plan, and a health insurance issuer with
respect to the provision of health insurance coverage, may not
retaliate against a participant, beneficiary, enrollee, or health care
provider based on the participant's, beneficiary's, enrollee's or
provider's use of, or participation in, a utilization review process or
a grievance process of the plan or issuer (including an internal or
external review or appeal process) under this title.
(b) Protection for Quality Advocacy by Health Care Professionals.--
(1) In general.--A group health plan or health insurance
issuer may not retaliate or discriminate against a protected
health care professional because the professional in good
faith--
(A) discloses information relating to the care,
services, or conditions affecting one or more
participants, beneficiaries, or enrollees of the plan
or issuer to an appropriate public regulatory agency,
an appropriate private accreditation body, or
appropriate management personnel of the plan or issuer;
or
(B) initiates, cooperates, or otherwise
participates in an investigation or proceeding by such
an agency with respect to such care, services, or
conditions.
If an institutional health care provider is a participating
provider with such a plan or issuer or otherwise receives
payments for benefits provided by such a plan or issuer, the
provisions of the previous sentence shall apply to the provider
in relation to care, services, or conditions affecting one or
more patients within an institutional health care provider in
the same manner as they apply to the plan or issuer in relation
to care, services, or conditions provided to one or more
participants, beneficiaries, or enrollees; and for purposes of
applying this sentence, any reference to a plan or issuer is
deemed a reference to the institutional health care provider.
(2) Good faith action.--For purposes of paragraph (1), a
protected health care professional is considered to be acting
in good faith with respect to disclosure of information or
participation if, with respect to the information disclosed as
part of the action--
(A) the disclosure is made on the basis of personal
knowledge and is consistent with that degree of
learning and skill ordinarily possessed by health care
professionals with the same licensure or certification
and the same experience;
(B) the professional reasonably believes the
information to be true;
(C) the information evidences either a violation of
a law, rule, or regulation, of an applicable
accreditation standard, or of a generally recognized
professional or clinical standard or that a patient is
in imminent hazard of loss of life or serious injury;
and
(D) subject to subparagraphs (B) and (C) of
paragraph (3), the professional has followed reasonable
internal procedures of the plan, issuer, or
institutional health care provider established for the
purpose of addressing quality concerns before making
the disclosure.
(3) Exception and special rule.--
(A) General exception.--Paragraph (1) does not
protect disclosures that would violate Federal or State
law or diminish or impair the rights of any person to
the continued protection of confidentiality of
communications provided by such law.
(B) Notice of internal procedures.--Subparagraph
(D) of paragraph (2) shall not apply unless the
internal procedures involved are reasonably expected to
be known to the health care professional involved. For
purposes of this subparagraph, a health care
professional is reasonably expected to know of internal
procedures if those procedures have been made available to the
professional through distribution or posting.
(C) Internal procedure exception.--Subparagraph (D)
of paragraph (2) also shall not apply if--
(i) the disclosure relates to an imminent
hazard of loss of life or serious injury to a
patient;
(ii) the disclosure is made to an
appropriate private accreditation body pursuant
to disclosure procedures established by the
body; or
(iii) the disclosure is in response to an
inquiry made in an investigation or proceeding
of an appropriate public regulatory agency and
the information disclosed is limited to the
scope of the investigation or proceeding.
(4) Additional considerations.--It shall not be a violation
of paragraph (1) to take an adverse action against a protected
health care professional if the plan, issuer, or provider
taking the adverse action involved demonstrates that it would
have taken the same adverse action even in the absence of the
activities protected under such paragraph.
(5) Notice.--A group health plan, health insurance issuer,
and institutional health care provider shall post a notice, to
be provided or approved by the Secretary of Labor, setting
forth excerpts from, or summaries of, the pertinent provisions
of this subsection and information pertaining to enforcement of
such provisions.
(6) Constructions.--
(A) Determinations of coverage.--Nothing in this
subsection shall be construed to prohibit a plan or
issuer from making a determination not to pay for a
particular medical treatment or service or the services
of a type of health care professional.
(B) Enforcement of peer review protocols and
internal procedures.--Nothing in this subsection shall
be construed to prohibit a plan, issuer, or provider
from establishing and enforcing reasonable peer review
or utilization review protocols or determining whether
a protected health care professional has complied with
those protocols or from establishing and enforcing
internal procedures for the purpose of addressing
quality concerns.
(C) Relation to other rights.--Nothing in this
subsection shall be construed to abridge rights of
participants, beneficiaries, enrollees, and protected
health care professionals under other applicable
Federal or State laws.
(7) Protected health care professional defined.--For
purposes of this subsection, the term ``protected health care
professional'' means an individual who is a licensed or
certified health care professional and who--
(A) with respect to a group health plan or health
insurance issuer, is an employee of the plan or issuer
or has a contract with the plan or issuer for provision
of services for which benefits are available under the
plan or issuer; or
(B) with respect to an institutional health care
provider, is an employee of the provider or has a
contract or other arrangement with the provider
respecting the provision of health care services.
Subtitle E--Definitions
SEC. 151. DEFINITIONS.
(a) Incorporation of General Definitions.--Except as otherwise
provided, the provisions of section 2791 of the Public Health Service
Act shall apply for purposes of this title in the same manner as they
apply for purposes of title XXVII of such Act.
(b) Secretary.--Except as otherwise provided, the term
``Secretary'' means the Secretary of Health and Human Services, in
consultation with the Secretary of Labor and the term ``appropriate
Secretary'' means the Secretary of Health and Human Services in
relation to carrying out this title under sections 2706 and 2751 of the
Public Health Service Act and the Secretary of Labor in relation to
carrying out this title under section 713 of the Employee Retirement
Income Security Act of 1974.
(c) Additional Definitions.--For purposes of this title:
(1) Actively practicing.--The term ``actively practicing''
means, with respect to a physician or other health care
professional, such a physician or professional who provides
professional services to individual patients on average at
least two full days per week.
(2) Applicable authority.--The term ``applicable
authority'' means--
(A) in the case of a group health plan, the
Secretary of Health and Human Services and the
Secretary of Labor; and
(B) in the case of a health insurance issuer with
respect to a specific provision of this title, the
applicable State authority (as defined in section
2791(d) of the Public Health Service Act), or the
Secretary of Health and Human Services, if such
Secretary is enforcing such provision under section
2722(a)(2) or 2761(a)(2) of the Public Health Service
Act.
(3) Clinical peer.--The term ``clinical peer'' means, with
respect to a review or appeal, an actively practicing physician
(allopathic or osteopathic) or other actively practicing health
care professional who holds a nonrestricted license, and who is
appropriately credentialed in the same or similar specialty or
subspecialty (as appropriate) as typically handles the medical
condition, procedure, or treatment under review or appeal and
includes a pediatric specialist where appropriate; except that
only a physician (allopathic or osteopathic) may be a clinical
peer with respect to the review or appeal of treatment
recommended or rendered by a physician.
(4) Enrollee.--The term ``enrollee'' means, with respect to
health insurance coverage offered by a health insurance issuer,
an individual enrolled with the issuer to receive such
coverage.
(5) Group health plan.--The term ``group health plan'' has
the meaning given such term in section 733(a) of the Employee
Retirement Income Security Act of 1974 and in section
2791(a)(1) of the Public Health Service Act.
(6) Health care professional.--The term ``health care
professional'' means an individual who is licensed, accredited,
or certified under State law to provide specified health care
services and who is operating within the scope of such
licensure, accreditation, or certification.
(7) Health care provider.--The term ``health care
provider'' includes a physician or other health care
professional, as well as an institutional or other facility or
agency that provides health care services and that is licensed,
accredited, or certified to provide health care items and
services under applicable State law.
(8) Network.--The term ``network'' means, with respect to a
group health plan or health insurance issuer offering health
insurance coverage, the participating health care professionals
and providers through whom the plan or issuer provides health
care items and services to participants, beneficiaries, or
enrollees.
(9) Nonparticipating.--The term ``nonparticipating'' means,
with respect to a health care provider that provides health
care items and services to a participant, beneficiary, or
enrollee under group health plan or health insurance coverage,
a health care provider that is not a participating health care
provider with respect to such items and services.
(10) Participating.--The term ``participating'' means, with
respect to a health care provider that provides health care
items and services to a participant, beneficiary, or enrollee
under group health plan or health insurance coverage offered by
a health insurance issuer, a health care provider that
furnishes such items and services under a contract or other
arrangement with the plan or issuer.
(11) Prior authorization.--The term ``prior authorization''
means the process of obtaining prior approval from a health
insurance issuer or group health plan for the provision or
coverage of medical services.
SEC. 152. PREEMPTION; STATE FLEXIBILITY; CONSTRUCTION.
(a) Continued Applicability of State Law With Respect to Health
Insurance Issuers.--
(1) In general.--Subject to paragraph (2), this title shall
not be construed to supersede any provision of State law which
establishes, implements, or continues in effect any standard or
requirement solely relating to health insurance issuers (in
connection with group health insurance coverage or otherwise)
except to the extent that such standard or requirement prevents
the application of a requirement of this title.
(2) Continued preemption with respect to group health
plans.--Nothing in this title shall be construed to affect or
modify the provisions of section 514 of the Employee Retirement
Income Security Act of 1974 with respect to group health plans.
(b) Definitions.--For purposes of this section:
(1) State law.--The term ``State law'' includes all laws,
decisions, rules, regulations, or other State action having the
effect of law, of any State. A law of the United States
applicable only to the District of Columbia shall be treated as a State
law rather than a law of the United States.
(2) State.--The term ``State'' includes a State, the
District of Columbia, Puerto Rico, the Virgin Islands, Guam,
American Samoa, the Northern Mariana Islands, any political
subdivisions of such, or any agency or instrumentality of such.
SEC. 153. EXCLUSIONS.
(a) No Benefit Requirements.--Nothing in this title shall be
construed to require a group health plan or a health insurance issuer
offering health insurance coverage to include specific items and
services under the terms of such a plan or coverage, other than those
that are provided for under the terms of such plan or coverage.
(b) Exclusion From Access to Care Managed Care Provisions for Fee-
for-Service Coverage.--
(1) In general.--The provisions of sections 111 through 117
shall not apply to a group health plan or health insurance
coverage if the only coverage offered under the plan or
coverage is fee-for-service coverage (as defined in paragraph
(2)).
(2) Fee-for-service coverage defined.--For purposes of this
subsection, the term ``fee-for-service coverage'' means
coverage under a group health plan or health insurance coverage
that--
(A) reimburses hospitals, health professionals, and
other providers on the basis of a rate determined by
the plan or issuer on a fee-for-service basis without
placing the provider at financial risk;
(B) does not vary reimbursement for such a provider
based on an agreement to contract terms and conditions
or the utilization of health care items or services
relating to such provider;
(C) does not restrict the selection of providers
among those who are lawfully authorized to provide the
covered services and agree to accept the terms and
conditions of payment established under the plan or by
the issuer; and
(D) for which the plan or issuer does not require
prior authorization before providing coverage for any
services.
SEC. 154. COVERAGE OF LIMITED SCOPE PLANS.
Only for purposes of applying the requirements of this title under
sections 2707 and 2753 of the Public Health Service Act and section 714
of the Employee Retirement Income Security Act of 1974, section
2791(c)(2)(A), and section 733(c)(2)(A) of the Employee Retirement
Income Security Act of 1974 shall be deemed not to apply.
SEC. 155. REGULATIONS.
The Secretaries of Health and Human Services and Labor shall issue
such regulations as may be necessary or appropriate to carry out this
title. Such regulations shall be issued consistent with section 104 of
Health Insurance Portability and Accountability Act of 1996. Such
Secretaries may promulgate any interim final rules as the Secretaries
determine are appropriate to carry out this title.
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.
(a) In General.--Subpart 2 of part A of title XXVII of the Public
Health Service Act is amended by adding at the end the following new
section:
``SEC. 2707. PATIENT PROTECTION STANDARDS.
``(a) In General.--Each group health plan shall comply with patient
protection requirements under title I of the Patients' Bill of Rights
Act, and each health insurance issuer shall comply with patient
protection requirements under such title with respect to group health
insurance coverage it offers, and such requirements shall be deemed to
be incorporated into this subsection.
``(b) Notice.--A group health plan shall comply with the notice
requirement under section 711(d) of the Employee Retirement Income
Security Act of 1974 with respect to the requirements referred to in
subsection (a) and a health insurance issuer shall comply with such
notice requirement as if such section applied to such issuer and such
issuer were a group health plan.''.
(b) Conforming Amendment.--Section 2721(b)(2)(A) of such Act (42
U.S.C. 300gg-21(b)(2)(A)) is amended by inserting ``(other than section
2707)'' after ``requirements of such subparts''.
SEC. 202. APPLICATION TO INDIVIDUAL HEALTH INSURANCE COVERAGE.
Part B of title XXVII of the Public Health Service Act is amended
by inserting after section 2752 the following new section:
``SEC. 2753. PATIENT PROTECTION STANDARDS.
``(a) In General.--Each health insurance issuer shall comply with
patient protection requirements under title I of the Patients' Bill of
Rights Act with respect to individual health insurance coverage it
offers, and such requirements shall be deemed to be incorporated into
this subsection.
``(b) Notice.--A health insurance issuer under this part shall
comply with the notice requirement under section 711(d) of the Employee
Retirement Income Security Act of 1974 with respect to the requirements
of such title as if such section applied to such issuer and such issuer
were a group health plan.''.
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.
Subpart B of part 7 of subtitle B of title I of the Employee
Retirement Income Security Act of 1974 is amended by adding at the end
the following new section:
``SEC. 714. PATIENT PROTECTION STANDARDS.
``(a) In General.--Subject to subsection (b), a group health plan
(and a health insurance issuer offering group health insurance coverage
in connection with such a plan) shall comply with the requirements of
title I of the Patients' Bill of Rights Act (as in effect as of the
date of the enactment of such Act), and such requirements shall be
deemed to be incorporated into this subsection.
``(b) Plan Satisfaction of Certain Requirements.--
``(1) Satisfaction of certain requirements through
insurance.--For purposes of subsection (a), insofar as a group
health plan provides benefits in the form of health insurance
coverage through a health insurance issuer, the plan shall be
treated as meeting the following requirements of title I of the
Patients' Bill of Rights Act with respect to such benefits and
not be considered as failing to meet such requirements because
of a failure of the issuer to meet such requirements so long as
the plan sponsor or its representatives did not cause such
failure by the issuer:
``(A) Section 112 (relating to choice of
providers).
``(B) Section 113 (relating to access to emergency
care).
``(C) Section 114 (relating to access to specialty
care).
``(D) Section 115 (relating to access to
obstetrical and gynecological care).
``(E) Section 116 (relating to access to pediatric
care).
``(F) Section 117(a)(1) (relating to continuity in
case of termination of provider contract) and section
117(a)(2) (relating to continuity in case of
termination of issuer contract), but only insofar as a
replacement issuer assumes the obligation for
continuity of care.
``(G) Section 118 (relating to access to needed
prescription drugs).
``(H) Section 119 (relating to coverage for
individuals participating in approved clinical trials.)
``(I) Section 134 (relating to payment of claims).
``(2) Information.--With respect to information required to
be provided or made available under section 121, in the case of
a group health plan that provides benefits in the form of
health insurance coverage through a health insurance issuer,
the Secretary shall determine the circumstances under which the
plan is not required to provide or make available the
information (and is not liable for the issuer's failure to
provide or make available the information), if the issuer is obligated
to provide and make available (or provides and makes available) such
information.
``(3) Grievance and internal appeals.--With respect to the
internal appeals process and the grievance system required to
be established under sections 102 and 104, in the case of a
group health plan that provides benefits in the form of health
insurance coverage through a health insurance issuer, the
Secretary shall determine the circumstances under which the
plan is not required to provide for such process and system
(and is not liable for the issuer's failure to provide for such
process and system), if the issuer is obligated to provide for
(and provides for) such process and system.
``(4) External appeals.--Pursuant to rules of the
Secretary, insofar as a group health plan enters into a
contract with a qualified external appeal entity for the
conduct of external appeal activities in accordance with
section 103, the plan shall be treated as meeting the
requirement of such section and is not liable for the entity's
failure to meet any requirements under such section.
``(5) Application to prohibitions.--Pursuant to rules of
the Secretary, if a health insurance issuer offers health
insurance coverage in connection with a group health plan and
takes an action in violation of any of the following sections,
the group health plan shall not be liable for such violation
unless the plan caused such violation:
``(A) Section 131 (relating to prohibition of
interference with certain medical communications).
``(B) Section 132 (relating to prohibition of
discrimination against providers based on licensure).
``(C) Section 133 (relating to prohibition against
improper incentive arrangements).
``(D) Section 135 (relating to protection for
patient advocacy).
``(6) Construction.--Nothing in this subsection shall be
construed to affect or modify the responsibilities of the
fiduciaries of a group health plan under part 4 of subtitle B.
``(7) Application to certain prohibitions against
retaliation.--With respect to compliance with the requirements
of section 135(b)(1) of the Patients' Bill of Rights Act, for
purposes of this subtitle the term `group health plan' is
deemed to include a reference to an institutional health care
provider.
``(c) Enforcement of Certain Requirements.--
``(1) Complaints.--Any protected health care professional
who believes that the professional has been retaliated or
discriminated against in violation of section 135(b)(1) of the
Patients' Bill of Rights Act may file with the Secretary a
complaint within 180 days of the date of the alleged
retaliation or discrimination.
``(2) Investigation.--The Secretary shall investigate such
complaints and shall determine if a violation of such section
has occurred and, if so, shall issue an order to ensure that
the protected health care professional does not suffer any loss
of position, pay, or benefits in relation to the plan, issuer,
or provider involved, as a result of the violation found by the
Secretary.
``(d) Conforming Regulations.--The Secretary may issue regulations
to coordinate the requirements on group health plans under this section
with the requirements imposed under the other provisions of this
title.''.
(b) Satisfaction of ERISA Claims Procedure Requirement.--Section
503 of such Act (29 U.S.C. 1133) is amended by inserting ``(a)'' after
``Sec. 503.'' and by adding at the end the following new subsection:
``(b) In the case of a group health plan (as defined in section
733) compliance with the requirements of subtitle A of title I of the
Patients Bill of Rights Act in the case of a claims denial shall be
deemed compliance with subsection (a) with respect to such claims
denial.''.
(c) Conforming Amendments.--(1) Section 732(a) of such Act (29
U.S.C. 1185(a)) is amended by striking ``section 711'' and inserting
``sections 711 and 714''.
(2) The table of contents in section 1 of such Act is amended by
inserting after the item relating to section 713 the following new
item:
``Sec. 714. Patient protection standards.''.
(3) Section 502(b)(3) of such Act (29 U.S.C. 1132(b)(3)) is amended
by inserting ``(other than section 135(b))'' after ``part 7''.
SEC. 302. ERISA PREEMPTION NOT TO APPLY TO CERTAIN ACTIONS INVOLVING
HEALTH INSURANCE POLICYHOLDERS.
(a) In General.--Section 514 of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1144) (as amended by section 301(b)) is
amended further by adding at the end the following subsections:
``(f) Preemption Not To Apply to Certain Actions Arising Out of
Provision of Health Benefits.--
``(1) Non-preemption of certain causes of action.--
``(A) In general.--Except as provided in this
subsection, nothing in this title shall be construed to
invalidate, impair, or supersede any cause of action by
a participant or beneficiary (or the estate of a
participant or beneficiary) under State law to recover
damages resulting from personal injury or for wrongful
death against any person--
``(i) in connection with the provision of
insurance, administrative services, or medical
services by such person to or for a group
health plan as defined in section 733), or
``(ii) that arises out of the arrangement
by such person for the provision of such
insurance, administrative services, or medical
services by other persons.
``(B) Limitation on punitive damages.--
``(i) In general.--No person shall be
liable for any punitive, exemplary, or similar
damages in the case of a cause of action
brought under subparagraph (A) if--
``(I) it relates to an externally
appealable decision (as defined in
subsection (a)(2) of section 103 of the
Patients' Bill of Rights Act);
``(II) an external appeal with
respect to such decision was completed
under such section 103;
``(III) in the case such external
appeal was initiated by the plan or
issuer filing the request for the
external appeal, the request was filed
on a timely basis before the date the
action was brought or, if later, within
30 days after the date the externally
appealable decision was made; and
``(IV) the plan or issuer complied
with the determination of the external
appeal entity upon receipt of the
determination of the external appeal
entity.
The provisions of this clause supersede any
State law or common law to the contrary.
``(ii) Exception.--Clause (i) shall not
apply with respect to damages in the case of a
cause of action for wrongful death if the
applicable State law provides (or has been
construed to provide) for damages in such a
cause of action which are only punitive or
exemplary in nature.
``(C) Personal injury defined.--For purposes of
this subsection, the term `personal injury' means a
physical injury and includes an injury arising out of
the treatment (or failure to treat) a mental illness or
disease.
``(2) Exception for group health plans, employers, and
other plan sponsors.--
``(A) In general.--Subject to subparagraph (B),
paragraph (1) does not authorize--
``(i) any cause of action against a group
health plan or an employer or other plan
sponsor maintaining the plan (or against an
employee of such a plan, employer, or sponsor
acting within the scope of employment), or
``(ii) a right of recovery, indemnity, or
contribution by a person against a group health
plan or an employer or other plan sponsor (or
such an employee) for damages assessed against
the person pursuant to a cause of action under
paragraph (1).
``(B) Special rule.--Subparagraph (A) shall not
preclude any cause of action described in paragraph (1)
against group health plan or an employer or other plan
sponsor (or against an employee of such a plan,
employer, or sponsor acting within the scope of
employment) if--
``(i) such action is based on the exercise
by the plan, employer, or sponsor (or employee)
of discretionary authority to make a decision
on a claim for benefits covered under the plan
or health insurance coverage in the case at
issue; and
``(ii) the exercise by the plan, employer,
or sponsor (or employee) of such authority
resulted in personal injury or wrongful death.
``(C) Exception.--The exercise of discretionary
authority described in subparagraph (B)(i) shall not be
construed to include--
``(i) the decision to include or exclude
from the plan any specific benefit;
``(ii) any decision to provide extra-
contractual benefits; or
``(iii) any decision not to consider the
provision of a benefit while internal or
external review is being conducted.
``(3) Futility of exhaustion.--An individual bringing an
action under this subsection is required to exhaust
administrative processes under sections 102 and 103 of the
Patients' Bill of Rights Act, unless the injury to or death of
such individual has occurred before the completion of such
processes.
``(4) Construction.--Nothing in this subsection shall be
construed as--
``(A) permitting a cause of action under State law
for the failure to provide an item or service which is
specifically excluded under the group health plan
involved;
``(B) as preempting a State law which requires an
affidavit or certificate of merit in a civil action; or
``(C) permitting a cause of action or remedy under
State law in connection with the provision or
arrangement of excepted benefits (as defined in section
733(c)), other than those described in section
733(c)(2)(A).
``(g) Rules of Construction Relating to Health Care.--Nothing in
this title shall be construed as--
``(1) permitting the application of State laws that are
otherwise superseded by this title and that mandate the
provision of specific benefits by a group health plan (as
defined in section 733(a)) or a multiple employer welfare
arrangement (as defined in section 3(40)), or
``(2) affecting any State law which regulates the practice
of medicine or provision of medical care, or affecting any
action based upon such a State law.''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to acts and omissions occurring on or after the date of enactment
of this Act, from which a cause of action arises.
SEC. 303. LIMITATIONS ON ACTIONS.
Section 502 of the Employee Retirement Income Security Act of 1974
(29 U.S.C. 1132) is amended further by adding at the end the following
new subsection:
``(n)(1) Except as provided in this subsection, no action may be
brought under subsection (a)(1)(B), (a)(2), or (a)(3) by a participant
or beneficiary seeking relief based on the application of any provision
in section 101, subtitle B, or subtitle D of title I of the Patients'
Bill of Rights Act (as incorporated under section 714).
``(2) An action may be brought under subsection (a)(1)(B), (a)(2),
or (a)(3) by a participant or beneficiary seeking relief based on the
application of section 101, 113, 114, 115, 116, 117, 119, or 118(3) of
the Patients' Bill of Rights Act (as incorporated under section 714) to
the individual circumstances of that participant or beneficiary, except
that--
``(A) such an action may not be brought or maintained as a
class action; and
``(B) in such an action, relief may only provide for the
provision of (or payment of) benefits, items, or services
denied to the individual participant or beneficiary involved
(and for attorney's fees and the costs of the action, at the
discretion of the court) and shall not provide for any other
relief to the participant or beneficiary or for any relief to
any other person.
``(3) Nothing in this subsection shall be construed as affecting
any action brought by the Secretary.''.
TITLE IV--APPLICATION TO GROUP HEALTH PLANS UNDER THE INTERNAL REVENUE
CODE OF 1986
SEC. 401. AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986.
Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is
amended--
(1) in the table of sections, by inserting after the item
relating to section 9812 the following new item:
``Sec. 9813. Standard relating to patient
freedom of choice.'';
and
(2) by inserting after section 9812 the following:
``SEC. 9813. STANDARD RELATING TO PATIENTS' BILL OF RIGHTS.
``A group health plan shall comply with the requirements of title I
of the Patients' Bill of Rights Act (as in effect as of the date of the
enactment of such Act), and such requirements shall be deemed to be
incorporated into this section.''.
TITLE V--EFFECTIVE DATES; COORDINATION IN IMPLEMENTATION
SEC. 501. EFFECTIVE DATES.
(a) Group Health Coverage.--
(1) In general.--Subject to paragraph (2), the amendments
made by sections 201(a), 301, 303, and 401 (and title I insofar
as it relates to such sections) shall apply with respect to
group health plans, and health insurance coverage offered in
connection with group health plans, for plan years beginning on
or after January 1, 2002 (in this section referred to as the
``general effective date'') and also shall apply to portions of
plan years occurring on and after such date.
(2) Treatment of collective bargaining agreements.--In the
case of a group health plan maintained pursuant to one or more
collective bargaining agreements between employee
representatives and one or more employers ratified before the
date of the enactment of this Act, the amendments made by
sections 201(a), 301, 303, and 401 (and title I insofar as it
relates to such sections) shall not apply to plan years
beginning before the later of--
(A) the date on which the last collective
bargaining agreements relating to the plan terminates
(determined without regard to any extension thereof
agreed to after the date of the enactment of this Act);
or
(B) the general effective date.
For purposes of subparagraph (A), any plan amendment made
pursuant to a collective bargaining agreement relating to the
plan which amends the plan solely to conform to any requirement
added by this Act shall not be treated as a termination of such
collective bargaining agreement.
(b) Individual Health Insurance Coverage.--The amendments made by
section 202 shall apply with respect to individual health insurance
coverage offered, sold, issued, renewed, in effect, or operated in the
individual market on or after the general effective date.
SEC. 502. COORDINATION IN IMPLEMENTATION.
The Secretary of Labor, the Secretary of Health and Human Services,
and the Secretary of the Treasury shall ensure, through the execution
of an interagency memorandum of understanding among such Secretaries,
that--
(1) regulations, rulings, and interpretations issued by
such Secretaries relating to the same matter over which such
Secretaries have responsibility under the provisions of this
Act (and the amendments made thereby) are administered so as to
have the same effect at all times; and
(2) coordination of policies relating to enforcing the same
requirements through such Secretaries in order to have a
coordinated enforcement strategy that avoids duplication of
enforcement efforts and assigns priorities in enforcement.
TITLE VI--MISCELLANEOUS PROVISIONS
SEC. 601. HEALTH CARE PAPERWORK SIMPLIFICATION.
(a) Establishment of Panel.--
(1) Establishment.--There is established a panel to be
known as the Health Care Panel to Devise a Uniform Explanation
of Benefits (in this section referred to as the ``Panel'').
(2) Duties of panel.--
(A) In general.--The Panel shall devise a single
form for use by third-party health care payers for the
remittance of claims to providers.
(B) Definition.--For purposes of this section, the
term ``third-party health care payer'' means any entity
that contractually pays health care bills for an
individual.
(3) Membership.--
(A) Size and composition.--The Secretary of Health
and Human Services shall determine the number of
members and the composition of the Panel. Such Panel
shall include equal numbers of representatives of
private insurance organizations, consumer groups, State
insurance commissioners, State medical societies, State
hospital associations, and State medical specialty
societies.
(B) Terms of appointment.--The members of the Panel
shall serve for the life of the Panel.
(C) Vacancies.--A vacancy in the Panel shall not
affect the power of the remaining members to execute
the duties of the Panel, but any such vacancy shall be
filled in the same manner in which the original
appointment was made.
(4) Procedures.--
(A) Meetings.--The Panel shall meet at the call of
a majority of its members.
(B) First meeting.--The Panel shall convene not
later than 60 days after the date of the enactment of
the Patients' Bill of Rights Act.
(C) Quorum.--A quorum shall consist of a majority
of the members of the Panel.
(D) Hearings.--For the purpose of carrying out its
duties, the Panel may hold such hearings and undertake
such other activities as the Panel determines to be
necessary to carry out its duties.
(5) Administration.--
(A) Compensation.--Except as provided in
subparagraph (B), members of the Panel shall receive no
additional pay, allowances, or benefits by reason of
their service on the Panel.
(B) Travel expenses and per diem.--Each member of
the Panel who is not an officer or employee of the
Federal Government shall receive travel expenses and
per diem in lieu of subsistence in accordance with
sections 5702 and 5703 of title 5, United States Code.
(C) Contract authority.--The Panel may contract
with and compensate Government and private agencies or
persons for items and services, without regard to
section 3709 of the Revised Statutes (41 U.S.C. 5).
(D) Use of mails.--The Panel may use the United
States mails in the same manner and under the same
conditions as Federal agencies and shall, for purposes of the frank, be
considered a commission of Congress as described in section 3215 of
title 39, United States Code.
(E) Administrative support services.--Upon the
request of the Panel, the Secretary of Health and Human
Services shall provide to the Panel on a reimbursable
basis such administrative support services as the Panel
may request.
(6) Submission of form.--Not later than 2 years after the
first meeting, the Panel shall submit a form to the Secretary
of Health and Human Services for use by third-party health care
payers.
(7) Termination.--The Panel shall terminate on the day
after submitting the form under paragraph (6).
(b) Requirement for Use of Form by Third-Party Care Payers.--A
third-party health care payer shall be required to use the form devised
under subsection (a) for plan years beginning on or after 5 years
following the date of the enactment of this Act.
SEC. 602. NO IMPACT ON SOCIAL SECURITY TRUST FUND.
(a) In General.--Nothing in this Act (or an amendment made by this
Act) shall be construed to alter or amend the Social Security Act (or
any regulation promulgated under that Act).
(b) Transfers.--
(1) Estimate of secretary.--The Secretary of the Treasury
shall annually estimate the impact that the enactment of this
Act has on the income and balances of the trust funds
established under section 201 of the Social Security Act (42
U.S.C. 401).
(2) Transfer of funds.--If, under paragraph (1), the
Secretary of the Treasury estimates that the enactment of this
Act has a negative impact on the income and balances of the
trust funds established under section 201 of the Social
Security Act (42 U.S.C. 401), the Secretary shall transfer, not
less frequently than quarterly, from the general revenues of
the Federal Government an amount sufficient so as to ensure
that the income and balances of such trust funds are not
reduced as a result of the enactment of such Act.
<all>