[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 283 Introduced in Senate (IS)]
107th CONGRESS
1st Session
S. 283
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
February 7, 2001
Mr. McCain (for himself, Mr. Edwards, Mr. Kennedy, Mr. Chafee, Mr.
Graham, Mr. Specter, Mrs. Lincoln, Mr. Harkin, Mr. Baucus, Mr.
Torricelli, Mr. Dodd, Mr. Nelson of Florida, Mr. Schumer, and Mr.
Corzine) 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 ``Bipartisan Patient
Protection Act of 2001''.
(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--Utilization Review; Claims; and Internal and External
Appeals
Sec. 101. Utilization review activities.
Sec. 102. Procedures for initial claims for benefits and prior
authorization determinations.
Sec. 103. Internal appeals of claims denials.
Sec. 104. Independent external appeals procedures.
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. Timely access to specialists.
Sec. 115. Patient 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.
Sec. 120. Required coverage for minimum hospital stay for mastectomies
and lymph node dissections for the
treatment of breast cancer and coverage for
secondary consultations.
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.
Sec. 156. Incorporation into plan or coverage documents.
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. Availability of civil remedies.
Sec. 303. Limitations on actions.
TITLE IV--AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986
Sec. 401. Application of requirements to group health plans under the
Internal Revenue Code of 1986.
Sec. 402. Conforming enforcement for women's health and cancer rights.
TITLE V--EFFECTIVE DATES; COORDINATION IN IMPLEMENTATION
Sec. 501. Effective dates.
Sec. 502. Coordination in implementation.
Sec. 503. Severability.
TITLE I--IMPROVING MANAGED CARE
Subtitle A--Utilization Review; Claims; and Internal and External
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 and section 102.
(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 a participant,
beneficiary, or 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 a periodic 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 and appropriate.
SEC. 102. PROCEDURES FOR INITIAL CLAIMS FOR BENEFITS AND PRIOR
AUTHORIZATION DETERMINATIONS.
(a) Procedures of Initial Claims for Benefits.--
(1) In general.--A group health plan, or health insurance
issuer offering health insurance coverage, shall--
(A) make a determination on an initial claim for
benefits by a participant, beneficiary, or enrollee (or
authorized representative) regarding payment or
coverage for items or services under the terms and
conditions of the plan or coverage involved, including
any cost-sharing amount that the participant,
beneficiary, or enrollee is required to pay with
respect to such claim for benefits; and
(B) notify a participant, beneficiary, or enrollee
(or authorized representative) and the treating health
care professional involved regarding a determination on
an initial claim for benefits made under the terms and
conditions of the plan or coverage, including any cost-
sharing amounts that the participant, beneficiary, or
enrollee may be required to make with respect to such
claim for benefits, and of the right of the
participant, beneficiary, or enrollee to an internal
appeal under section 103.
(2) Access to information.--
(A) Timely provision of necessary information.--
With respect to an initial claim for benefits, the
participant, beneficiary, or enrollee (or authorized
representative) and the treating health care
professional (if any) shall provide the plan or issuer with access to
information requested by the plan or issuer that is necessary to make a
determination relating to the claim. Such access shall be provided not
later than 5 days after the date on which the request for information
is received, or, in a case described in subparagraph (B) or (C) of
subsection (b)(1), by such earlier time as may be necessary to comply
with the applicable timeline under such subparagraph.
(B) Limited effect of failure on plan or issuer's
obligations.--Failure of the participant, beneficiary,
or enrollee to comply with the requirements of
subparagraph (A) shall not remove the obligation of the
plan or issuer to make a decision in accordance with
the medical exigencies of the case and as soon as
possible, based on the available information, and
failure to comply with the time limit established by
this paragraph shall not remove the obligation of the
plan or issuer to comply with the requirements of this
section.
(3) Oral requests.--In the case of a claim for benefits
involving an expedited or concurrent determination, a
participant, beneficiary, or enrollee (or authorized
representative) may make an initial claim for benefits orally,
but a group health plan, or health insurance issuer offering
health insurance coverage, may require that the participant,
beneficiary, or enrollee (or authorized representative) provide
written confirmation of such request in a timely manner on a
form provided by the plan or issuer. In the case of such an
oral request for benefits, the making of the request (and the
timing of such request) shall be treated as the making at that
time of a claims for such benefits without regard to whether
and when a written confirmation of such request is made.
(b) Timeline for Making Determinations.--
(1) Prior authorization determination.--
(A) In general.--A group health plan, or health
insurance issuer offering health insurance coverage,
shall make a prior authorization determination on a
claim for benefits (whether oral or written) in
accordance with the medical exigencies of the case and
as soon as possible, but in no case later than 14 days
from the date on which the plan or issuer receives
information that is reasonably necessary to enable the
plan or issuer to make a determination on the request
for prior authorization and in no case later than 28
days after the date of the claim for benefits is
received.
(B) Expedited determination.--Notwithstanding
subparagraph (A), a group health plan, or health
insurance issuer offering health insurance coverage,
shall expedite a prior authorization determination on a
claim for benefits described in such subparagraph when
a request for such an expedited determination is made
by a participant, beneficiary, or enrollee (or
authorized representative) at any time during the
process for making a determination and a health care
professional certifies, with the request, that a
determination under the procedures described in
subparagraph (A) would seriously jeopardize the life or
health of the participant, beneficiary, or enrollee or
the ability of the participant, beneficiary, or
enrollee to maintain or regain maximum function. Such
determination shall be made in accordance with the
medical exigencies of the case and as soon as possible,
but in no case later than 72 hours after the time the
request is received by the plan or issuer under this
subparagraph.
(C) Ongoing care.--
(i) Concurrent review.--
(I) In general.--Subject to clause
(ii), in the case of a concurrent
review of ongoing care (including
hospitalization), which results in a
termination or reduction of such care,
the plan or issuer 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 in accordance with the
medical exigencies of the case and as
soon as possible, with sufficient time
prior to the termination or reduction
to allow for an appeal under section
103(b)(3) 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.
(ii) Rule of construction.--Clause (i)
shall not be construed as requiring plans or
issuers to provide coverage of care that would
exceed the coverage limitations for such care.
(2) Retrospective determination.--A group health plan, or
health insurance issuer offering health insurance coverage,
shall make a retrospective determination on a claim for
benefits in accordance with the medical exigencies of the case
and as soon as possible, but not later than 30 days after the
date on which the plan or issuer receives information that is
reasonably necessary to enable the plan or issuer to make a
determination on the claim, or, if earlier, 60 days after the
date of receipt of the claim for benefits.
(c) Notice of a Denial of a Claim for Benefits.--Written notice of
a denial made under an initial claim for benefits shall be issued to
the participant, beneficiary, or enrollee (or authorized
representative) and the treating health care professional in accordance
with the medical exigencies of the case and as soon as possible, but in
no case later than 2 days after the date of the determination (or, in
the case described in subparagraph (B) or (C) of subsection (b)(1),
within the 72-hour or applicable period referred to in such
subparagraph).
(d) Requirements of Notice of Determinations.--The written notice
of a denial of a claim for benefits determination under subsection (c)
shall be provided in printed form and written in a manner calculated to
be understood by the average participant, beneficiary, or enrollee and
shall include--
(1) the specific reasons for the determination (including a
summary of the clinical or scientific evidence used in making
the determination);
(2) the procedures for obtaining additional information
concerning the determination; and
(3) notification of the right to appeal the determination
and instructions on how to initiate an appeal in accordance
with section 103.
(e) Definitions.--For purposes of this part:
(1) Authorized representative.--The term ``authorized
representative'' means, with respect to an individual who is a
participant, beneficiary, or enrollee, any health care
professional or other person acting on behalf of the individual
with the individual's consent or without such consent if the
individual is medically unable to provide such consent.
(2) 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.
(3) Denial of claim for benefits.--The term ``denial''
means, with respect to a claim for benefits, a denial (in whole
or in part) of, or a failure to act on a timely basis upon, the
claim for benefits and includes a failure to provide benefits
(including items and services) required to be provided under
this title.
(4) Treating health care professional.--The term ``treating
health care professional'' means, with respect to services to
be provided to a participant, beneficiary, or enrollee, a
health care professional who is primarily responsible for
delivering those services to the participant, beneficiary, or
enrollee.
SEC. 103. INTERNAL APPEALS OF CLAIMS DENIALS.
(a) Right to Internal Appeal.--
(1) In general.--A participant, beneficiary, or enrollee
(or authorized representative) may appeal any denial of a claim
for benefits under section 102 under the procedures described
in this section.
(2) Time for appeal.--
(A) In general.--A group health plan, or health
insurance issuer offering health insurance coverage,
shall ensure that a participant, beneficiary, or
enrollee (or authorized representative) has a period of
not less than 180 days beginning on the date of a
denial of a claim for benefits under section 102 in
which to appeal such denial under this section.
(B) Date of denial.--For purposes of subparagraph
(A), the date of the denial shall be deemed to be the
date as of which the participant, beneficiary, or
enrollee knew of the denial of the claim for benefits.
(3) Failure to act.--The failure of a plan or issuer to
issue a determination on a claim for benefits under section 102
within the applicable timeline established for such a
determination under such section is a denial of a claim for
benefits for purposes this subtitle as of the date of the
applicable deadline.
(4) Plan waiver of internal review.--A group health plan,
or health insurance issuer offering health insurance coverage,
may waive the internal review process under this section. In
such case the plan or issuer shall provide notice to the
participant, beneficiary, or enrollee (or authorized
representative) involved, the participant, beneficiary, or
enrollee (or authorized representative) involved shall be
relieved of any obligation to complete the internal review
involved, and may, at the option of such participant,
beneficiary, enrollee, or representative proceed directly to
seek further appeal through external review under section 104
or otherwise.
(b) Timelines for Making Determinations.--
(1) Oral requests.--In the case of an appeal of a denial of
a claim for benefits under this section that involves an
expedited or concurrent determination, a participant,
beneficiary, or enrollee (or authorized representative) may
request such appeal orally. A group health plan, or health
insurance issuer offering health insurance coverage, may
require that the participant, beneficiary, or enrollee (or
authorized representative) provide written confirmation of such
request in a timely manner on a form provided by the plan or
issuer. In the case of such an oral request for an appeal of a
denial, the making of the request (and the timing of such request)
shall be treated as the making at that time of a request for an appeal
without regard to whether and when a written confirmation of such
request is made.
(2) Access to information.--
(A) Timely provision of necessary information.--
With respect to an appeal of a denial of a claim for
benefits, the participant, beneficiary, or enrollee (or
authorized representative) and the treating health care
professional (if any) shall provide the plan or issuer
with access to information requested by the plan or
issuer that is necessary to make a determination
relating to the appeal. Such access shall be provided
not later than 5 days after the date on which the
request for information is received, or, in a case
described in subparagraph (B) or (C) of paragraph (3),
by such earlier time as may be necessary to comply with
the applicable timeline under such subparagraph.
(B) Limited effect of failure on plan or issuer's
obligations.--Failure of the participant, beneficiary,
or enrollee to comply with the requirements of
subparagraph (A) shall not remove the obligation of the
plan or issuer to make a decision in accordance with
the medical exigencies of the case and as soon as
possible, based on the available information, and
failure to comply with the time limit established by
this paragraph shall not remove the obligation of the
plan or issuer to comply with the requirements of this
section.
(3) Prior authorization determinations.--
(A) In general.--A group health plan, or health
insurance issuer offering health insurance coverage,
shall make a determination on an appeal of a denial of
a claim for benefits under this subsection in
accordance with the medical exigencies of the case and
as soon as possible, but in no case later than 14 days
from the date on which the plan or issuer receives
information that is reasonably necessary to enable the
plan or issuer to make a determination on the appeal
and in no case later than 28 days after the date the
request for the appeal is received.
(B) Expedited determination.--Notwithstanding
subparagraph (A), a group health plan, or health
insurance issuer offering health insurance coverage,
shall expedite a prior authorization determination on
an appeal of a denial of a claim for benefits described
in subparagraph (A), when a request for such an
expedited determination is made by a participant,
beneficiary, or enrollee (or authorized representative)
at any time during the process for making a
determination and a health care professional certifies,
with the request, that a determination under the
procedures described in subparagraph (A) would
seriously jeopardize the life or health of the
participant, beneficiary, or enrollee or the ability of
the participant, beneficiary, or enrollee to maintain
or regain maximum function. Such determination shall be
made in accordance with the medical exigencies of the
case and as soon as possible, but in no case later than
72 hours after the time the request for such appeal is
received by the plan or issuer under this subparagraph.
(C) Ongoing care determinations.--
(i) In general.--Subject to clause (ii), in
the case of a concurrent review determination
described in section 102(b)(1)(C)(i)(I), which
results in a termination or reduction of such
care, the plan or issuer must provide notice of
the determination on the appeal under this
section by telephone and in printed form to the
individual or the individual's designee and the
individual's health care provider in accordance
with the medical exigencies of the case and as
soon as possible, with sufficient time prior to
the termination or reduction to allow for an
external appeal under section 104 to be
completed before the termination or reduction
takes effect.
(ii) Rule of construction.--Clause (i)
shall not be construed as requiring plans or
issuers to provide coverage of care that would
exceed the coverage limitations for such care.
(4) Retrospective determination.--A group health plan, or
health insurance issuer offering health insurance coverage,
shall make a retrospective determination on an appeal of a
claim for benefits in no case later than 30 days after the date
on which the plan or issuer receives necessary information that is
reasonably necessary to enable the plan or issuer to make a
determination on the appeal and in no case later than 60 days after the
date the request for the appeal is received.
(c) Conduct of Review.--
(1) In general.--A review of a denial of a claim for
benefits under this section shall be conducted by an individual
with appropriate expertise who was not involved in the initial
determination.
(2) Review of medical decisions by physicians.--A review of
an appeal of a denial of a claim for benefits that is based on
a lack of medical necessity and appropriateness, or based on an
experimental or investigational treatment, or requires an
evaluation of medical facts, shall be made by a physician
(allopathic or osteopathic) with appropriate expertise
(including, in the case of a child, appropriate pediatric
expertise) who was not involved in the initial determination.
(d) Notice of Determination.--
(1) In general.--Written notice of a determination made
under an internal appeal of a denial of a claim for benefits
shall be issued to the participant, beneficiary, or enrollee
(or authorized representative) and the treating health care
professional in accordance with the medical exigencies of the
case and as soon as possible, but in no case later than 2 days
after the date of completion of the review (or, in the case
described in subparagraph (B) or (C) of subsection (b)(3),
within the 72-hour or applicable period referred to in such
subparagraph).
(2) Final determination.--The decision by a plan or issuer
under this section shall be treated as the final determination
of the plan or issuer on a denial of a claim for benefits. The
failure of a plan or issuer to issue a determination on an
appeal of a denial of a claim for benefits under this section
within the applicable timeline established for such a
determination shall be treated as a final determination on an
appeal of a denial of a claim for benefits for purposes of
proceeding to external review under section 104.
(3) Requirements of notice.--With respect to a
determination made under this section, the notice described in
paragraph (1) shall be provided in printed form and written in
a manner calculated to be understood by the average
participant, beneficiary, or enrollee and shall include--
(A) the specific reasons for the determination
(including a summary of the clinical or scientific
evidence used in making the determination);
(B) the procedures for obtaining additional
information concerning the determination; and
(C) notification of the right to an independent
external review under section 104 and instructions on
how to initiate such a review.
SEC. 104. INDEPENDENT EXTERNAL APPEALS PROCEDURES.
(a) Right to External Appeal.--A group health plan, and a health
insurance issuer offering health insurance coverage, shall provide in
accordance with this section participants, beneficiaries, and enrollees
(or authorized representatives) with access to an independent external
review for any denial of a claim for benefits.
(b) Initiation of the Independent External Review Process.--
(1) Time to file.--A request for an independent external
review under this section shall be filed with the plan or
issuer not later than 180 days after the date on which the
participant, beneficiary, or enrollee receives notice of the
denial under section 103(d) or notice of waiver of internal
review under section 103(a)(4) or the date on which the plan or
issuer has failed to make a timely decision under section
103(d)(2) and notifies the participant or beneficiary that it
has failed to make a timely decision and that the beneficiary
must file an appeal with an external review entity within 180
days if the participant or beneficiary desires to file such an
appeal.
(2) Filing of request.--
(A) In general.--Subject to the succeeding
provisions of this subsection, a group health plan, and
a health insurance issuer offering health insurance
coverage, may--
(i) except as provided in subparagraph
(B)(i), require that a request for review be in
writing;
(ii) limit the filing of such a request to
the participant, beneficiary, or enrollee
involved (or an authorized representative);
(iii) except if waived by the plan or
issuer under section 103(a)(4), condition
access to an independent external review under
this section upon a final determination of a
denial of a claim for benefits under the
internal review procedure under section 103;
(iv) except as provided in subparagraph
(B)(ii), require payment of a filing fee to the
plan or issuer of a sum that does not exceed
$25; and
(v) require that a request for review
include the consent of the participant,
beneficiary, or enrollee (or authorized
representative) for the release of necessary
medical information or records of the
participant, beneficiary, or enrollee to the
qualified external review entity only for
purposes of conducting external review
activities.
(B) Requirements and exception relating to general
rule.--
(i) Oral requests permitted in expedited or
concurrent cases.--In the case of an expedited
or concurrent external review as provided for
under subsection (e), the request may be made
orally. A group health plan, or health
insurance issuer offering health insurance
coverage, may require that the
participant, beneficiary, or enrollee (or authorized representative)
provide written confirmation of such request in a timely manner on a
form provided by the plan or issuer. Such written confirmation shall be
treated as a consent for purposes of subparagraph (A)(v). In the case
of such an oral request for such a review, the making of the request
(and the timing of such request) shall be treated as the making at that
time of a request for such an external review without regard to whether
and when a written confirmation of such request is made.
(ii) Exception to filing fee requirement.--
(I) Indigency.--Payment of a filing
fee shall not be required under
subparagraph (A)(iv) where there is a
certification (in a form and manner
specified in guidelines established by
the appropriate Secretary) that the
participant, beneficiary, or enrollee
is indigent (as defined in such
guidelines).
(II) Fee not required.--Payment of
a filing fee shall not be required
under subparagraph (A)(iv) if the plan
or issuer waives the internal appeals
process under section 103(a)(4).
(III) Refunding of fee.--The filing
fee paid under subparagraph (A)(iv)
shall be refunded if the determination
under the independent external review
is to reverse or modify the denial
which is the subject of the review.
(IV) Collection of filing fee.--The
failure to pay such a filing fee shall
not prevent the consideration of a
request for review but, subject to the
preceding provisions of this clause,
shall constitute a legal liability to
pay.
(c) Referral to Qualified External Review Entity Upon Request.--
(1) In general.--Upon the filing of a request for
independent external review with the group health plan, or
health insurance issuer offering health insurance coverage, the
plan or issuer shall immediately refer such request, and
forward the plan or issuer's initial decision (including the
information described in section 103(d)(3)(A)), to a qualified
external review entity selected in accordance with this
section.
(2) Access to plan or issuer and health professional
information.--With respect to an independent external review
conducted under this section, the participant, beneficiary, or
enrollee (or authorized representative), the plan or issuer,
and the treating health care professional (if any) shall
provide the external review entity with information that is
necessary to conduct a review under this section, as determined
and requested by the entity. Such information shall be provided
not later than 5 days after the date on which the request for
information is received, or, in a case described in clause (ii)
or (iii) of subsection (e)(1)(A), by such earlier time as may
be necessary to comply with the applicable timeline under such
clause.
(3) Screening of requests by qualified external review
entities.--
(A) In general.--With respect to a request referred
to a qualified external review entity under paragraph
(1) relating to a denial of a claim for benefits, the
entity shall refer such request for the conduct of an
independent medical review unless the entity determines
that--
(i) any of the conditions described in
clauses (ii) or (iii) of subsection (b)(2)(A)
have not been met;
(ii) the denial of the claim for benefits
does not involve a medically reviewable
decision under subsection (d)(2);
(iii) the denial of the claim for benefits
relates to a decision regarding whether an
individual is a participant, beneficiary, or
enrollee who is enrolled under the terms and
conditions of the plan or coverage (including
the applicability of any waiting period under
the plan or coverage); or
(iv) the denial of the claim for benefits
is a decision as to the application of cost-
sharing requirements or the application of a
specific exclusion or express limitation on the
amount, duration, or scope of coverage of items
or services under the terms and conditions of
the plan or coverage unless the decision is a
denial described in subsection (d)(2).
Upon making a determination that any of clauses (i)
through (iv) applies with respect to the request, the
entity shall determine that the denial of a claim for
benefits involved is not eligible for independent
medical review under subsection (d), and shall provide
notice in accordance with subparagraph (C).
(B) Process for making determinations.--
(i) No deference to prior determinations.--
In making determinations under subparagraph
(A), there shall be no deference given to
determinations made by the plan or issuer or
the recommendation of a treating health care
professional (if any).
(ii) Use of appropriate personnel.--A
qualified external review entity shall use
appropriately qualified personnel to make
determinations under this section.
(C) Notices and general timelines for
determination.--
(i) Notice in case of denial of referral.--
If the entity under this paragraph does not
make a referral to an independent medical
reviewer, the entity shall provide notice to
the plan or issuer, the participant,
beneficiary, or enrollee (or authorized
representative) filing the request, and the
treating health care professional (if any) that
the denial is not subject to independent
medical review. Such notice--
(I) shall be written (and, in
addition, may be provided orally) in a
manner calculated to be understood by
an average participant or enrollee;
(II) shall include the reasons for
the determination;
(III) include any relevant terms
and conditions of the plan or coverage;
and
(IV) include a description of any
further recourse available to the
individual.
(ii) General timeline for determinations.--
Upon receipt of information under paragraph
(2), the qualified external review entity, and
if required the independent medical reviewer,
shall make a determination within the overall
timeline that is applicable to the case under
review as described in subsection (e), except
that if the entity determines that a referral
to an independent medical reviewer is not
required, the entity shall provide notice of
such determination to the participant,
beneficiary, or enrollee (or authorized
representative) within such timeline and within
2 days of the date of such determination.
(d) Independent Medical Review.--
(1) In general.--If a qualified external review entity
determines under subsection (c) that a denial of a claim for
benefits is eligible for independent medical review, the entity
shall refer the denial involved to an independent medical
reviewer for the conduct of an independent medical review under
this subsection.
(2) Medically reviewable decisions.--A denial of a claim
for benefits is eligible for independent medical review if the
benefit for the item or service for which the claim is made
would be a covered benefit under the terms and conditions of
the plan or coverage but for one (or more) of the following
determinations:
(A) Denials based on medical necessity and
appropriateness.--A determination that the item or
service is not covered because it is not medically
necessary and appropriate or based on the application
of substantially equivalent terms.
(B) Denials based on experimental or
investigational treatment.--A determination that the
item or service is not covered because it is
experimental or investigational or based on the
application of substantially equivalent terms.
(C) Denials otherwise based on an evaluation of
medical facts.--A determination that the item or
service or condition is not covered based on grounds
that require an evaluation of the medical facts by a
health care professional in the specific case involved
to determine the coverage and extent of coverage of the
item or service or condition.
(3) Independent medical review determination.--
(A) In general.--An independent medical reviewer
under this section shall make a new independent
determination with respect to whether or not the denial
of a claim for a benefit that is the subject of the
review should be upheld, reversed, or modified.
(B) Standard for determination.--The independent
medical reviewer's determination relating to the
medical necessity and appropriateness, or the
experimental or investigation nature, or the evaluation
of the medical facts of the item, service, or condition
shall be based on the medical condition of the
participant, beneficiary, or enrollee (including the
medical records of the participant, beneficiary, or
enrollee) and valid, relevant scientific evidence and
clinical evidence, including peer-reviewed medical
literature or findings and including expert opinion.
(C) No coverage for excluded benefits.--Nothing in
this subsection shall be construed to permit an
independent medical reviewer to require that a group
health plan, or health insurance issuer offering health
insurance coverage, provide coverage for items
or services for which benefits are specifically excluded or expressly
limited under the plan or coverage in the plain language of the plan
document (and which are disclosed under section 121(b)(1)(C)) except to
the extent that the application or interpretation of the exclusion or
limitation involves a determination described in paragraph (2).
(D) Evidence and information to be used in medical
reviews.--In making a determination under this
subsection, the independent medical reviewer shall also
consider appropriate and available evidence and
information, including the following:
(i) The determination made by the plan or
issuer with respect to the claim upon internal
review and the evidence, guidelines, or
rationale used by the plan or issuer in
reaching such determination.
(ii) The recommendation of the treating
health care professional and the evidence,
guidelines, and rationale used by the treating
health care professional in reaching such
recommendation.
(iii) Additional relevant evidence or
information obtained by the reviewer or
submitted by the plan, issuer, participant,
beneficiary, or enrollee (or an authorized
representative), or treating health care
professional.
(iv) The plan or coverage document.
(E) Independent determination.--In making
determinations under this subtitle, a qualified
external review entity and an independent medical
reviewer shall--
(i) consider the claim under review without
deference to the determinations made by the
plan or issuer or the recommendation of the
treating health care professional (if any); and
(ii) consider, but not be bound by the
definition used by the plan or issuer of
``medically necessary and appropriate'', or
``experimental or investigational'', or other
substantially equivalent terms that are used by
the plan or issuer to describe medical
necessity and appropriateness or experimental
or investigational nature of the treatment.
(F) Determination of independent medical
reviewer.--An independent medical reviewer shall, in
accordance with the deadlines described in subsection
(e), prepare a written determination to uphold,
reverse, or modify the denial under review. Such
written determination shall include--
(i) the determination of the reviewer;
(ii) the specific reasons of the reviewer
for such determination, including a summary of
the clinical or scientific evidence used in
making the determination; and
(iii) with respect to a determination to
reverse or modify the denial under review, a
timeframe within which the plan or issuer must
comply with such determination.
(G) Nonbinding nature of additional
recommendations.--In addition to the determination
under subparagraph (F), the reviewer may provide the
plan or issuer and the treating health care
professional with additional recommendations in
connection with such a determination, but any such
recommendations shall not affect (or be treated as part
of) the determination and shall not be binding on the
plan or issuer.
(e) Timelines and Notifications.--
(1) Timelines for independent medical review.--
(A) Prior authorization determination.--
(i) In general.--The independent medical
reviewer (or reviewers) shall make a
determination on a denial of a claim for
benefits that is referred to the reviewer under
subsection (c)(3) in accordance with the
medical exigencies of the case and as soon as
possible, but in no case later than 14 days
after the date of receipt of information under
subsection (c)(2) if the review involves a
prior authorization of items or services and in
no case later than 21 days after the date the
request for external review is received.
(ii) Expedited determination.--
Notwithstanding clause (i) and subject to
clause (iii), the independent medical reviewer
(or reviewers) shall make an expedited
determination on a denial of a claim for
benefits described in clause (i), when a
request for such an expedited determination is
made by a participant, beneficiary, or enrollee
(or authorized representative) at any time
during the process for making a determination,
and a health care professional certifies, with
the request, that a determination under the
timeline described in clause (i) would
seriously jeopardize the life or health of the
participant, beneficiary, or enrollee or the
ability of the participant, beneficiary, or
enrollee to maintain or regain maximum
function. Such determination shall be made as
soon in accordance with the medical exigencies
of the case and as soon as possible, but in no
case later than 72 hours after the time the
request for external review is received by the
qualified external review entity.
(iii) Ongoing care determination.--
Notwithstanding clause (i), in the case of a
review described in such subclause that
involves a termination or reduction of care,
the notice of the determination shall be
completed not later than 24 hours after the
time the request for external review is
received by the qualified external review
entity and before the end of the approved
period of care.
(B) Retrospective determination.--The independent
medical reviewer (or reviewers) shall complete a review
in the case of a retrospective determination on an
appeal of a denial of a claim for benefits that is
referred to the reviewer under subsection (c)(3) in no
case later than 30 days after the date of receipt of
information under subsection (c)(2) and in no case
later than 60 days after the date the request for
external review is received by the qualified external
review entity.
(2) Notification of determination.--The external review
entity shall ensure that the plan or issuer, the participant,
beneficiary, or enrollee (or authorized representative) and the
treating health care professional (if any) receives a copy of
the written determination of the independent medical reviewer
prepared under subsection (d)(3)(F). Nothing in this paragraph
shall be construed as preventing an entity or reviewer from
providing an initial oral notice of the reviewer's determination.
(3) Form of notices.--Determinations and notices under this
subsection shall be written in a manner calculated to be
understood by an average participant.
(f) Compliance.--
(1) Application of determinations.--
(A) External review determinations binding on
plan.--The determinations of an external review entity
and an independent medical reviewer under this section
shall be binding upon the plan or issuer involved.
(B) Compliance with determination.--If the
determination of an independent medical reviewer is to
reverse or modify the denial, the plan or issuer, upon
the receipt of such determination, shall authorize
coverage to comply with the medical reviewer's
determination in accordance with the timeframe
established by the medical reviewer.
(2) Failure to comply.--
(A) In general.--If a plan or issuer fails to
comply with the timeframe established under paragraph
(1)(B) with respect to a participant, beneficiary, or
enrollee, where such failure to comply is caused by the
plan or issuer, the participant, beneficiary, or
enrollee may obtain the items or services involved (in
a manner consistent with the determination of the
independent external reviewer) from any provider
regardless of whether such provider is a participating
provider under the plan or coverage.
(B) Reimbursement.--
(i) In general.--Where a participant,
beneficiary, or enrollee obtains items or
services in accordance with subparagraph (A),
the plan or issuer involved shall provide for
reimbursement of the costs of such items or
services. Such reimbursement shall be made to
the treating health care professional or to the
participant, beneficiary, or enrollee (in the
case of a participant, beneficiary, or enrollee
who pays for the costs of such items or
services).
(ii) Amount.--The plan or issuer shall
fully reimburse a professional, participant,
beneficiary, or enrollee under clause (i) for
the total costs of the items or services
provided (regardless of any plan limitations
that may apply to the coverage of such items or
services) so long as the items or services were
provided in a manner consistent with the
determination of the independent medical
reviewer.
(C) Failure to reimburse.--Where a plan or issuer
fails to provide reimbursement to a professional,
participant, beneficiary, or enrollee in accordance
with this paragraph, the professional, participant,
beneficiary, or enrollee may commence a civil action
(or utilize other remedies available under law) to
recover only the amount of any such reimbursement that
is owed by the plan or issuer and any necessary legal
costs or expenses (including attorney's fees) incurred
in recovering such reimbursement.
(D) Available remedies.--The remedies provided
under this paragraph are in addition to any other
available remedies.
(3) Penalties against authorized officials for refusing to
authorize the determination of an external review entity.--
(A) Monetary penalties.--
(i) In general.--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.
(ii) Additional penalty for failing to
follow timeline.--In any case in which
treatment was not commenced by the plan in
accordance with the determination of an
independent external reviewer, the Secretary
shall assess a civil penalty of $10,000 against
the plan and the plan shall pay such penalty to
the participant, beneficiary, or enrollee
involved.
(B) Cease and desist order and order of attorney's
fees.--In any action described in subparagraph (A)
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
subparagraph has taken an action resulting in a refusal
of a benefit determined by an external appeal entity to
be covered, or has failed to take an action for which
such person is responsible under the terms and
conditions of the plan or coverage 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--
(i) to cease and desist from the alleged
action or failure to act; and
(ii) 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.
(C) Additional civil penalties.--
(i) In general.--In addition to any penalty
imposed under subparagraph (A) or (B), 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
to be covered; or
(II) any pattern or practice of
repeated violations of the requirements
of this section with respect to such
plan or coverage.
(ii) 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.
(D) Removal and disqualification.--Any person
acting in the capacity of authorizing benefits who has
engaged in any such pattern or practice described in
subparagraph (C)(i) 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.
(4) Protection of legal rights.--Nothing in this subsection
or 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.
(g) Qualifications of Independent Medical Reviewers.--
(1) In general.--In referring a denial to 1 or more
individuals to conduct independent medical review under
subsection (c), the qualified external review entity shall
ensure that--
(A) each independent medical reviewer meets the
qualifications described in paragraphs (2) and (3);
(B) with respect to each review at least 1 such
reviewer meets the requirements described in paragraphs
(4) and (5); and
(C) compensation provided by the entity to the
reviewer is consistent with paragraph (6).
(2) Licensure and expertise.--Each independent medical
reviewer shall be a physician (allopathic or osteopathic) or
health care professional who--
(A) is appropriately credentialed or licensed in 1
or more States to deliver health care services; and
(B) typically treats the condition, makes the
diagnosis, or provides the type of treatment under
review.
(3) Independence.--
(A) In general.--Subject to subparagraph (B), each
independent medical reviewer in a case shall--
(i) not be a related party (as defined in
paragraph (7));
(ii) not have a material familial,
financial, or professional relationship with
such a party; and
(iii) not otherwise have a conflict of
interest with such a party (as determined under
regulations).
(B) Exception.--Nothing in subparagraph (A) shall
be construed to--
(i) prohibit an individual, solely on the
basis of affiliation with the plan or issuer,
from serving as an independent medical reviewer
if--
(I) a non-affiliated individual is
not reasonably available;
(II) the affiliated individual is
not involved in the provision of items
or services in the case under review;
(III) the fact of such an
affiliation is disclosed to the plan or
issuer and the participant,
beneficiary, or enrollee (or authorized
representative) and neither party
objects; and
(IV) the affiliated individual is
not an employee of the plan or issuer
and does not provide services
exclusively or primarily to or on
behalf of the plan or issuer;
(ii) prohibit an individual who has staff
privileges at the institution where the
treatment involved takes place from serving as
an independent medical reviewer merely on the
basis of such affiliation if the affiliation is
disclosed to the plan or issuer and the
participant, beneficiary, or enrollee (or
authorized representative), and neither party
objects; or
(iii) prohibit receipt of compensation by
an independent medical reviewer from an entity
if the compensation is provided consistent with
paragraph (6).
(4) Practicing health care professional in same field.--
(A) In general.--In a case involving treatment, or
the provision of items or services--
(i) by a physician, a reviewer shall be a
practicing physician (allopathic or
osteopathic) of the same or similar specialty,
as a physician who typically treats the
condition, makes the diagnosis, or provides the
type of treatment under review; or
(ii) by a health care professional (other
than a physician), a reviewer shall be a
practicing physician (allopathic or
osteopathic) or, if determined appropriate by
the qualified external review entity, a
practicing health care professional (other than
such a physician), of the same or similar
specialty as the health care professional who
typically treats the condition, makes the
diagnosis, or provides the type of treatment
under review.
(B) Practicing defined.--For purposes of this
paragraph, the term ``practicing'' means, with respect
to an individual who is a physician or other health
care professional that the individual provides health
care services to individual patients on average at
least 2 days per week.
(5) Pediatric expertise.--In the case of an external review
relating to a child, a reviewer shall have expertise under
paragraph (2) in pediatrics.
(6) Limitations on reviewer compensation.--Compensation
provided by a qualified external review entity to an
independent medical reviewer in connection with a review under
this section shall--
(A) not exceed a reasonable level; and
(B) not be contingent on the decision rendered by
the reviewer.
(7) Related party defined.--For purposes of this section,
the term ``related party'' means, with respect to a denial of a
claim under a plan or coverage relating to a participant,
beneficiary, or enrollee, any of the following:
(A) The plan, plan sponsor, or issuer involved, or
any fiduciary, officer, director, or employee of such
plan, plan sponsor, or issuer.
(B) The participant, beneficiary, or enrollee (or
authorized representative).
(C) The health care professional that provides the
items or services involved in the denial.
(D) The institution at which the items or services
(or treatment) involved in the denial are provided.
(E) The manufacturer of any drug or other item that
is included in the items or services involved in the
denial.
(F) Any other party determined under any
regulations to have a substantial interest in the
denial involved.
(h) Qualified External Review Entities.--
(1) Selection of qualified external review entities.--
(A) Limitation on plan or issuer selection.--The
appropriate Secretary shall implement procedures--
(i) to assure that the selection process
among qualified external review entities will
not create any incentives for external review
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.
No such selection process under the procedures
implemented by the appropriate Secretary may give
either the patient or the plan or issuer any ability to
determine or influence the selection of a qualified
external review entity to review the case of any
participant, beneficiary, or enrollee.
(B) State authority with respect to qualified
external review entities 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) Contract with qualified external review entity.--Except
as provided in paragraph (1)(B), the external review process of
a plan or issuer under this section shall be conducted under a
contract between the plan or issuer and 1 or more qualified
external review entities (as defined in paragraph (4)(A)).
(3) Terms and conditions of contract.--The terms and
conditions of a contract under paragraph (2) shall--
(A) 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 review activities; and
(B) provide that the costs of the external review
process shall be borne by the plan or issuer.
Subparagraph (B) shall not be construed as applying to the
imposition of a filing fee under subsection (b)(2)(A)(iv) or
costs incurred by the participant, beneficiary, or enrollee (or
authorized representative) or treating health care professional
(if any) in support of the review, including the provision of
additional evidence or information.
(4) Qualifications.--
(A) In general.--In this section, the term
``qualified external review entity'' means, in relation
to a plan or issuer, an entity that is initially
certified (and periodically recertified) under
subparagraph (C) as meeting the following requirements:
(i) The entity has (directly or through
contracts or other arrangements) sufficient
medical, legal, and other expertise and
sufficient staffing to carry out duties of
a qualified external review entity under this section on a timely
basis, including making determinations under subsection (b)(2)(A) and
providing for independent medical reviews under subsection (d).
(ii) The entity is not a plan or issuer or
an affiliate or a subsidiary of a plan or
issuer, and is not an affiliate or subsidiary
of a professional or trade association of plans
or issuers or of health care providers.
(iii) The entity has provided assurances
that it will conduct external review activities
consistent with the applicable requirements of
this section and standards specified in
subparagraph (C), including that it will not
conduct any external review activities in a
case unless the independence requirements of
subparagraph (B) are met with respect to the
case.
(iv) The entity has provided assurances
that it will provide information in a timely
manner under subparagraph (D).
(v) The entity meets such other
requirements as the appropriate Secretary
provides by regulation.
(B) Independence requirements.--
(i) In general.--Subject to clause (ii), an
entity meets the independence requirements of
this subparagraph with respect to any case if
the entity--
(I) is not a related party (as
defined in subsection (g)(7));
(II) does not have a material
familial, financial, or professional
relationship with such a party; and
(III) does not otherwise have a
conflict of interest with such a party
(as determined under regulations).
(ii) Exception for reasonable
compensation.--Nothing in clause (i) shall be
construed to prohibit receipt by a qualified
external review entity of compensation from a
plan or issuer for the conduct of external
review activities under this section if the
compensation is provided consistent with clause
(iii).
(iii) Limitations on entity compensation.--
Compensation provided by a plan or issuer to a
qualified external review entity in connection
with reviews under this section shall--
(I) not exceed a reasonable level;
and
(II) not be contingent on any
decision rendered by the entity or by
any independent medical reviewer.
(C) Certification and recertification process.--
(i) In general.--The initial certification
and recertification of a qualified external
review entity shall be made--
(I) under a process that is
recognized or approved by the
appropriate Secretary; or
(II) by a qualified private
standard-setting organization that is
approved by the appropriate Secretary
under clause (iii).
In taking action under subclause (I), the
appropriate Secretary shall give deference to
entities that are under contract with the
Federal Government or with an applicable State
authority to perform functions of the type
performed by qualified external review
entities.
(ii) Process.--The appropriate Secretary
shall not recognize or approve a process under
clause (i)(I) unless the process applies
standards (as promulgated in regulations) that
ensure that a qualified external review
entity--
(I) will carry out (and has carried
out, in the case of recertification)
the responsibilities of such an entity
in accordance with this section,
including meeting applicable deadlines;
(II) will meet (and has met, in the
case of recertification) appropriate
indicators of fiscal integrity;
(III) will maintain (and has
maintained, in the case of
recertification) appropriate
confidentiality with respect to
individually identifiable health
information obtained in the course of
conducting external review activities;
and
(IV) in the case recertification,
shall review the matters described in
clause (iv).
(iii) Approval of qualified private
standard-setting organizations.--For purposes
of clause (i)(II), the appropriate Secretary
may approve a qualified private standard-
setting organization if such Secretary finds
that the organization only certifies (or
recertifies) external review entities that meet
at least the standards required for the
certification (or recertification) of external
review entities under clause (ii).
(iv) Considerations in recertifications.--
In conducting recertifications of a qualified
external review entity under this paragraph,
the appropriate Secretary or organization
conducting the recertification shall review
compliance of the entity with the requirements
for conducting external review activities under
this section, including the following:
(I) Provision of information under
subparagraph (D).
(II) Adherence to applicable
deadlines (both by the entity and by
independent medical reviewers it refers
cases to).
(III) Compliance with limitations
on compensation (with respect to both
the entity and independent medical
reviewers it refers cases to).
(IV) Compliance with applicable
independence requirements.
(v) Period of certification or
recertification.--A certification or
recertification provided under this paragraph
shall extend for a period not to exceed 2
years.
(vi) Revocation.--A certification or
recertification under this paragraph may be
revoked by the appropriate Secretary or by the
organization providing such certification upon
a showing of cause.
(vii) Sufficient number of entities.--The
appropriate Secretary shall certify and
recertify a number of external review entities
which is sufficient to ensure the timely and
efficient provision of review services.
(D) Provision of information.--
(i) In general.--A qualified external
review entity shall provide to the appropriate
Secretary, in such manner and at such times as
such Secretary may require, such information
(relating to the denials which have been
referred to the entity for the conduct of
external review under this section) as such
Secretary determines appropriate to assure
compliance with the independence and other
requirements of this section to monitor and
assess the quality of its external review
activities and lack of bias in making
determinations. Such information shall include
information described in clause (ii) but shall
not include individually identifiable medical
information.
(ii) Information to be included.--The
information described in this subclause with
respect to an entity is as follows:
(I) The number and types of denials
for which a request for review has been
received by the entity.
(II) The disposition by the entity
of such denials, including the number
referred to a independent medical
reviewer and the reasons for such
dispositions (including the application
of exclusions), on a plan or issuer-
specific basis and on a health care
specialty-specific basis.
(III) The length of time in making
determinations with respect to such
denials.
(IV) Updated information on the
information required to be submitted as
a condition of certification with
respect to the entity's performance of
external review activities.
(iii) Information to be provided to
certifying organization.--
(I) In general.--In the case of a
qualified external review entity which
is certified (or recertified) under
this subsection by a qualified private
standard-setting organization, at the
request of the organization, the entity
shall provide the organization with the
information provided to the appropriate
Secretary under clause (i).
(II) Additional information.--
Nothing in this subparagraph shall be
construed as preventing such an
organization from requiring additional
information as a condition of
certification or recertification of an
entity.
(iv) Use of information.--Information
provided under this subparagraph may be used by
the appropriate Secretary and qualified private
standard-setting organizations to conduct
oversight of qualified external review
entities, including recertification of such
entities, and shall be made available to the
public in an appropriate manner.
(E) Limitation on liability.--No qualified external
review entity having a contract with a plan or issuer,
and no person who is employed by any such entity or who
furnishes professional services to such entity
(including as an independent medical reviewer), shall
be held by reason of the performance of any duty,
function, or activity required or authorized pursuant
to this section, to be civilly liable under any law of
the United States or of any State (or political
subdivision thereof) if there was no actual malice or
gross misconduct in the performance of such duty,
function, or activity.
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 and 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 or covers any benefits with respect to services in an
emergency department of a hospital, the plan or issuer shall
cover emergency services (as defined in paragraph (2)(B))--
(A) without the need for any prior authorization
determination;
(B) whether the health care provider furnishing
such services is a participating provider with respect
to such services;
(C) in a manner so that, if such services are
provided to a participant, beneficiary, or enrollee--
(i) by a nonparticipating health care
provider with or without prior authorization,
or
(ii) by a participating health care
provider without prior authorization,
the participant, beneficiary, or enrollee is not liable
for amounts that exceed the amounts of liability that
would be incurred if the services were provided by a
participating health care provider with prior
authorization; and
(D) without regard to any other term or condition
of such coverage (other than exclusion or coordination
of benefits, or an affiliation or waiting period,
permitted under section 2701 of the Public Health
Service Act, section 701 of the Employee Retirement
Income Security Act of 1974, or section 9801 of the
Internal Revenue Code of 1986, and other than
applicable cost-sharing).
(2) Definitions.--In this section:
(A) Emergency medical condition.--The term
``emergency medical condition'' means 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, with respect to an emergency medical
condition--
(i) a medical screening examination (as
required under section 1867 of the Social
Security Act) that is within the capability of
the emergency department of a hospital,
including ancillary services routinely
available to the emergency department to
evaluate such emergency medical condition, and
(ii) within the capabilities of the staff
and facilities available at the hospital, such
further medical examination and treatment as
are required under section 1867 of such Act to
stabilize the patient.
(C) Stabilize.--The term ``to stabilize'', with
respect to an emergency medical condition (as defined
in subparagraph (A)), has the meaning give in section
1867(e)(3) of the Social Security Act (42 U.S.C.
1395dd(e)(3)).
(b) Reimbursement for Maintenance Care and Post-Stabilization
Care.--A group health plan, and health insurance coverage offered by a
health insurance issuer, must provide reimbursement for maintenance
care and post-stabilization care in accordance with the requirements of
section 1852(d)(2) of the Social Security Act (42 U.S.C. 1395w-
22(d)(2)). Such reimbursement shall be provided in a manner consistent
with subsection (a)(1)(C).
(c) Coverage of Emergency Ambulance Services.--
(1) In general.--If a group health plan, or health
insurance coverage provided by a health insurance issuer,
provides any benefits with respect to ambulance services and
emergency services, the plan or issuer shall cover emergency
ambulance services (as defined in paragraph (2)) furnished
under the plan or coverage under the same terms and conditions
under subparagraphs (A) through (D) of subsection (a)(1) under
which coverage is provided for emergency services.
(2) Emergency ambulance services.--For purposes of this
subsection, the term ``emergency ambulance services'' means
ambulance services (as defined for purposes of section
1861(s)(7) of the Social Security Act) furnished to transport an
individual who has an emergency medical condition (as defined in
subsection (a)(2)(A)) to a hospital for the receipt of emergency
services (as defined in subsection (a)(2)(B)) in a case in which the
emergency services are covered under the plan or coverage pursuant to
subsection (a)(1) and a prudent layperson, with an average knowledge of
health and medicine, could reasonably expect that the absence of such
transport would result in placing the health of the individual in
serious jeopardy, serious impairment of bodily function, or serious
dysfunction of any bodily organ or part.
SEC. 114. TIMELY ACCESS TO SPECIALISTS.
(a) Timely Access.--
(1) In general.--A group health plan or health insurance
issuer offering health insurance coverage shall ensure that
participants, beneficiaries, and enrollees receive timely
access to specialists who are appropriate to the condition of,
and accessible to, the participant, beneficiary, or enrollee,
when such specialty care is a covered benefit under the plan or
coverage.
(2) Rule of construction.--Nothing in paragraph (1) shall
be construed--
(A) to require the coverage under a group health
plan or health insurance coverage of benefits or
services;
(B) to prohibit a plan or issuer from including
providers in the network only to the extent necessary
to meet the needs of the plan's or issuer's
participants, beneficiaries, or enrollees; or
(C) to override any State licensure or scope-of-
practice law.
(3) Access to certain providers.--
(A) In general.--With respect to specialty care
under this section, if a participating specialist is
not available and qualified to provide such care to the
participant, beneficiary, or enrollee, the plan or
issuer shall provide for coverage of such care by a
nonparticipating specialist.
(B) Treatment of nonparticipating providers.--If a
participant, beneficiary, or enrollee receives care
from a nonparticipating specialist pursuant to
subparagraph (A), such specialty care shall be provided
at no additional cost to the participant, beneficiary,
or enrollee beyond what the participant, beneficiary,
or enrollee would otherwise pay for such specialty care
if provided by a participating specialist.
(b) Referrals.--
(1) Authorization.--A group health plan or health insurance
issuer may require an authorization in order to obtain coverage
for specialty services under this section. Any such
authorization--
(A) shall be for an appropriate duration of time or
number of referrals; and
(B) may not be refused solely because the
authorization involves services of a nonparticipating
specialist (described in subsection (a)(3)).
(2) Referrals for ongoing special conditions.--
(A) In general.--A group health plan or health
insurance issuer shall permit a participant,
beneficiary, or enrollee who has an ongoing special
condition (as defined in subparagraph (B)) to receive a
referral to a specialist for the treatment of such
condition and such specialist may authorize such
referrals, procedures, tests, and other medical
services with respect to such condition, or coordinate
the care for such condition, subject to the terms of a
treatment plan (if any) referred to in subsection (c)
with respect to the condition.
(B) Ongoing special condition defined.--In this
subsection, the term ``ongoing special condition''
means a condition or disease that--
(i) is life-threatening, degenerative,
potentially disabling, or congenital; and
(ii) requires specialized medical care over
a prolonged period of time.
(c) Treatment Plans.--
(1) In general.--A group health plan or health insurance
issuer may require that the specialty care be provided--
(A) pursuant to a treatment plan, but only if the
treatment plan--
(i) is developed by the specialist, in
consultation with the case manager or primary
care provider, and the participant,
beneficiary, or enrollee, and
(ii) is approved by the plan or issuer in a
timely manner, if the plan or issuer requires
such approval; and
(B) in accordance with applicable quality assurance
and utilization review standards of the plan or issuer.
(2) Notification.--Nothing in paragraph (1) shall be
construed as prohibiting a plan or issuer from requiring the
specialist to provide the plan or issuer with regular updates
on the specialty care provided, as well as all other reasonably
necessary medical information.
(d) Specialist Defined.--For purposes of this section, the term
``specialist'' means, with respect to the condition of the participant,
beneficiary, or enrollee, a health care professional, 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.
SEC. 115. PATIENT ACCESS TO OBSTETRIC AND GYNECOLOGICAL CARE.
(a) General Rights.--
(1) Direct access.--A group health plan, or health
insurance issuer offering health insurance coverage, described
in subsection (b) may not require authorization or referral by
the plan, issuer, or any person (including a primary care
provider described in subsection (b)(2)) in the case of a
female participant, beneficiary, or enrollee who seeks coverage
for obstetrical or gynecological care provided by a participating
health care professional who specializes in obstetrics or gynecology.
(2) Obstetrical and gynecological care.--A group health
plan or health insurance issuer described in subsection (b)
shall treat the provision of obstetrical and gynecological
care, and the ordering of related obstetrical and gynecological
items and services, pursuant to the direct access described
under paragraph (1), by a participating health care
professional who specializes in obstetrics or gynecology as the
authorization of the primary care provider.
(b) Application of Section.--A group health plan, or health
insurance issuer offering health insurance coverage, described in this
subsection is a group health plan or coverage that--
(1) provides coverage for obstetric or gynecologic care;
and
(2) requires the designation by a participant, beneficiary,
or enrollee of a participating primary care provider.
(c) Construction.--Nothing in subsection (a) shall be construed
to--
(1) waive any exclusions of coverage under the terms and
conditions 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.--In the case of a person who has a child who is
a participant, beneficiary, or enrollee under a group health plan, or
health insurance coverage offered by a health insurance issuer, if the
plan or issuer requires or provides for the designation of a
participating primary care provider for the child, the plan or issuer
shall permit such person to designate a physician (allopathic or
osteopathic) who specializes in pediatrics as the child's primary care
provider if such provider participates in the network of the plan or
issuer.
(b) Construction.--Nothing in subsection (a) shall be construed to
waive any exclusions of coverage under the terms and conditions of the
plan or health insurance coverage with respect to coverage of pediatric
care.
SEC. 117. CONTINUITY OF CARE.
(a) Termination of Provider.--
(1) In general.--If--
(A) a contract between a group health plan, or a
health insurance issuer offering health insurance
coverage, and a treating health care provider is
terminated (as defined in paragraph (e)(4)), or
(B) benefits or coverage provided by a health care
provider are terminated because of a change in the
terms of provider participation in such plan or
coverage,
the plan or issuer shall meet the requirements of paragraph (3)
with respect to each continuing care patient.
(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) Requirements.--The requirements of this paragraph are
that the plan or issuer--
(A) notify the continuing care patient involved, or
arrange to have the patient notified pursuant to
subsection (d)(2), on a timely basis of the termination
described in paragraph (1) (or paragraph (2), if
applicable) and the right to elect continued
transitional care from the provider under this section;
(B) provide the patient with an opportunity to
notify the plan or issuer of the patient's need for
transitional care; and
(C) subject to subsection (c), permit the patient
to elect to continue to be covered with respect to the
course of treatment by such provider with the
provider's consent during a transitional period (as
provided for under subsection (b)).
(4) Continuing care patient.--For purposes of this section,
the term ``continuing care patient'' means a participant,
beneficiary, or enrollee who--
(A) is undergoing a course of treatment for a
serious and complex condition from the provider at the
time the plan or issuer receives or provides notice of
provider, benefit, or coverage termination described in
paragraph (1) (or paragraph (2), if applicable);
(B) is undergoing a course of institutional or
inpatient care from the provider at the time of such
notice;
(C) is scheduled to undergo non-elective surgery
from the provider at the time of such notice;
(D) is pregnant and undergoing a course of
treatment for the pregnancy from the provider at the
time of such notice; or
(E) is or was determined to be terminally ill (as
determined under section 1861(dd)(3)(A) of the Social
Security Act) at the time of such notice, but only with
respect to a provider that was treating the terminal
illness before the date of such notice.
(b) Transitional Periods.--
(1) Serious and complex conditions.--The transitional
period under this subsection with respect to a continuing care
patient described in subsection (a)(4)(A) shall extend for up
to 90 days (as determined by the treating health care
professional) from the date of the notice described in
subsection (a)(3)(A).
(2) Institutional or inpatient care.--The transitional
period under this subsection for a continuing care patient
described in subsection (a)(4)(B) shall extend until the
earlier of--
(A) the expiration of the 90-day period beginning
on the date on which the notice under subsection
(a)(3)(A) is provided; or
(B) the date of discharge of the patient from such
care or the termination of the period of
institutionalization, or, if later, the date of
completion of reasonable follow-up care.
(3) Scheduled non-elective surgery.--The transitional
period under this subsection for a continuing care patient
described in subsection (a)(4)(C) shall extend until the
completion of the surgery involved and post-surgical follow-up
care relating to the surgery and occurring within 90 days after
the date of the surgery.
(4) Pregnancy.--The transitional period under this
subsection for a continuing care patient described in
subsection (a)(4)(D) shall extend through the provision of
post-partum care directly related to the delivery.
(5) Terminal illness.--The transitional period under this
subsection for a continuing care patient described in
subsection (a)(4)(E) shall extend for the remainder of the
patient's life for care that is 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 this section upon the provider agreeing to the
following terms and conditions:
(1) The treating health care provider agrees to accept
reimbursement from the plan or issuer and continuing care
patient 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
coverage after the date of the termination of the contract with
the group health plan or health insurance issuer) and not to
impose cost-sharing with respect to the patient 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 treating health care 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 treating health care 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) Rules of Construction.--Nothing in this section shall be
construed--
(1) to require the coverage of benefits which would not
have been covered if the provider involved remained a
participating provider; or
(2) with respect to the termination of a contract under
subsection (a) to prevent a group health plan or health
insurance issuer from requiring that the health care provider--
(A) notify participants, beneficiaries, or
enrollees of their rights under this section; or
(B) provide the plan or issuer with the name of
each participant, beneficiary, or enrollee who the
provider believes is a continuing care patient.
(e) Definitions.--In this section:
(1) Contract.--The term ``contract'' includes, with respect
to a plan or issuer and a treating health care provider, a
contract between such plan or issuer and an organized network
of providers that includes the treating health care provider,
and (in the case of such a contract) the contract between the
treating health care provider and the organized network.
(2) Health care provider.--The term ``health care
provider'' or ``provider'' means--
(A) any individual who is engaged in the delivery
of health care services in a State and who is required
by State law or regulation to be licensed or certified
by the State to engage in the delivery of such services
in the State; and
(B) any entity that is engaged in the delivery of
health care services in a State and that, if it is
required by State law or regulation to be licensed or
certified by the State to engage in the delivery of
such services in the State, is so licensed.
(3) Serious and complex condition.--The term ``serious and
complex condition'' means, with respect to a participant,
beneficiary, or enrollee under the plan or coverage--
(A) in the case of an acute illness, a condition
that is serious enough to require specialized medical
treatment to avoid the reasonable possibility of death
or permanent harm; or
(B) in the case of a chronic illness or condition,
is an ongoing special condition (as defined in section
114(b)(2)(B)).
(4) Terminated.--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
for failure to meet applicable quality standards or for fraud.
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 appropriate
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) The Food and Drug Administration.
(D) 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
appropriate 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.
SEC. 120. REQUIRED COVERAGE FOR MINIMUM HOSPITAL STAY FOR MASTECTOMIES
AND LYMPH NODE DISSECTIONS FOR THE TREATMENT OF BREAST
CANCER AND COVERAGE FOR SECONDARY CONSULTATIONS.
(a) Inpatient Care.--
(1) In general.--A group health plan, and a health
insurance issuer providing health insurance coverage, that
provides medical and surgical benefits shall ensure that
inpatient coverage with respect to the treatment of breast
cancer is provided for a period of time as is determined by the
attending physician, in consultation with the patient, to be
medically necessary and appropriate following--
(A) a mastectomy;
(B) a lumpectomy; or
(C) a lymph node dissection for the treatment of
breast cancer.
(2) Exception.--Nothing in this section shall be construed
as requiring the provision of inpatient coverage if the
attending physician and patient determine that a shorter period
of hospital stay is medically appropriate.
(b) Prohibition on Certain Modifications.--In implementing the
requirements of this section, a group health plan, and a health
insurance issuer providing health insurance coverage, may not modify
the terms and conditions of coverage based on the determination by a
participant, beneficiary, or enrollee to request less than the minimum
coverage required under subsection (a).
(c) Secondary Consultations.--
(1) In general.--A group health plan, and a health
insurance issuer providing health insurance coverage, that
provides coverage with respect to medical and surgical services
provided in relation to the diagnosis and treatment of cancer
shall ensure that full coverage is provided for secondary
consultations by specialists in the appropriate medical fields
(including pathology, radiology, and oncology) to confirm or
refute such diagnosis. Such plan or issuer shall ensure that
full coverage is provided for such secondary consultation
whether such consultation is based on a positive or negative
initial diagnosis. In any case in which the attending physician
certifies in writing that services necessary for such a
secondary consultation are not sufficiently available from
specialists operating under the plan or coverage with respect
to whose services coverage is otherwise provided under such
plan or by such issuer, such plan or issuer shall ensure that
coverage is provided with respect to the services necessary for
the secondary consultation with any other specialist selected
by the attending physician for such purpose at no additional
cost to the individual beyond that which the individual would
have paid if the specialist was participating in the network of
the plan or issuer.
(2) Exception.--Nothing in paragraph (1) shall be construed
as requiring the provision of secondary consultations where the
patient determines not to seek such a consultation.
(d) Prohibition on Penalties or Incentives.--A group health plan,
and a health insurance issuer providing health insurance coverage, may
not--
(1) penalize or otherwise reduce or limit the reimbursement
of a provider or specialist because the provider or specialist
provided care to a participant, beneficiary, or enrollee in
accordance with this section;
(2) provide financial or other incentives to a physician or
specialist to induce the physician or specialist to keep the
length of inpatient stays of patients following a mastectomy,
lumpectomy, or a lymph node dissection for the treatment of
breast cancer below certain limits or to limit referrals for
secondary consultations; or
(3) provide financial or other incentives to a physician or
specialist to induce the physician or specialist to refrain
from referring a participant, beneficiary, or enrollee for a
secondary consultation that would otherwise be covered by the
plan or coverage involved under subsection (c).
Subtitle C--Access to Information
SEC. 121. PATIENT ACCESS TO INFORMATION.
(a) Requirement.--
(1) Disclosure.--
(A) In general.--A group health plan, and a health
insurance issuer that provides coverage in connection
with health insurance coverage, shall provide for the
disclosure to participants, beneficiaries, and
enrollees--
(i) of the information described in
subsection (b) at the time of the initial
enrollment of the participant, beneficiary, or
enrollee under the plan or coverage;
(ii) of such information on an annual
basis--
(I) in conjunction with the
election period of the plan or coverage
if the plan or coverage has such an
election period; or
(II) in the case of a plan or
coverage that does not have an election
period, in conjunction with the
beginning of the plan or coverage year;
and
(iii) of information relating to any
material reduction to the benefits or
information described in such subsection or
subsection (c), in the form of a notice
provided not later than 30 days before the date
on which the reduction takes effect.
(B) Participants, beneficiaries, and enrollees.--
The disclosure required under subparagraph (A) shall be
provided--
(i) jointly to each participant,
beneficiary, and enrollee who reside at the
same address; or
(ii) in the case of a beneficiary or
enrollee who does not reside at the same
address as the participant or another enrollee,
separately to the participant or other
enrollees and such beneficiary or enrollee.
(2) Provision of information.--Information shall be
provided to participants, beneficiaries, and enrollees under
this section at the last known address maintained by the plan
or issuer with respect to such participants, beneficiaries, or
enrollees, to the extent that such information is provided to
participants, beneficiaries, or enrollees via the United States
Postal Service or other private delivery service.
(b) Required Information.--The informational materials to be
distributed under this section shall include for each option available
under the group health plan or health insurance coverage the following:
(1) Benefits.--A description of the covered benefits,
including--
(A) any in- and out-of-network benefits;
(B) specific preventive services covered under the
plan or coverage if such services are covered;
(C) any specific exclusions or express limitations
of benefits described in section 104(b)(3)(C);
(D) any other benefit limitations, including any
annual or lifetime benefit limits and any monetary
limits or limits on the number of visits, days, or
services, and any specific coverage exclusions; and
(E) any definition of medical necessity used in
making coverage determinations by the plan, issuer, or
claims administrator.
(2) Cost sharing.--A description of any cost-sharing
requirements, including--
(A) any premiums, deductibles, coinsurance,
copayment amounts, and liability for balance billing,
for which the participant, beneficiary, or enrollee
will be responsible under each option available under
the plan;
(B) any maximum out-of-pocket expense for which the
participant, beneficiary, or enrollee may be liable;
(C) any cost-sharing requirements for out-of-
network benefits or services received from
nonparticipating providers; and
(D) any additional cost-sharing or charges for
benefits and services that are furnished without
meeting applicable plan or coverage requirements, such
as prior authorization or precertification.
(3) Service area.--A description of the plan or issuer's
service area, including the provision of any out-of-area
coverage.
(4) Participating providers.--A directory of participating
providers (to the extent a plan or issuer provides coverage
through a network of providers) that includes, at a minimum,
the name, address, and telephone number of each participating
provider, and information about how to inquire whether a
participating provider is currently accepting new patients.
(5) Choice of primary care provider.--A description of any
requirements and procedures to be used by participants,
beneficiaries, and enrollees in selecting, accessing, or
changing their primary care provider, including providers both
within and outside of the network (if the plan or issuer
permits out-of-network services), and the right to select a
pediatrician as a primary care provider under section 116 for a
participant, beneficiary, or enrollee who is a child if such
section applies.
(6) Preauthorization requirements.--A description of the
requirements and procedures to be used to obtain
preauthorization for health services, if such preauthorization
is required.
(7) Experimental and investigational treatments.--A
description of the process for determining whether a particular
item, service, or treatment is considered experimental or
investigational, and the circumstances under which such
treatments are covered by the plan or issuer.
(8) Specialty care.--A description of the requirements and
procedures to be used by participants, beneficiaries, and
enrollees in accessing specialty care and obtaining referrals
to participating and nonparticipating specialists, including
any limitations on choice of health care professionals referred
to in section 112(b)(2) and the right to timely access to
specialists care under section 114 if such section applies.
(9) Clinical trials.--A description of the circumstances
and conditions under which participation in clinical trials is
covered under the terms and conditions of the plan or coverage,
and the right to obtain coverage for approved clinical trials
under section 119 if such section applies.
(10) Prescription drugs.--To the extent the plan or issuer
provides coverage for prescription drugs, a statement of
whether such coverage is limited to drugs included in a
formulary, a description of any provisions and cost-sharing
required for obtaining on- and off-formulary medications, and a
description of the rights of participants, beneficiaries, and
enrollees in obtaining access to access to prescription drugs
under section 118 if such section applies.
(11) Emergency services.--A summary of the rules and
procedures for accessing emergency services, including the
right of a participant, beneficiary, or enrollee to obtain
emergency services under the prudent layperson standard under
section 113, if such section applies, and any educational
information that the plan or issuer may provide regarding the
appropriate use of emergency services.
(12) Claims and appeals.--A description of the plan or
issuer's rules and procedures pertaining to claims and appeals,
a description of the rights (including deadlines for exercising
rights) of participants, beneficiaries, and enrollees under
subtitle A in obtaining covered benefits, filing a claim for
benefits, and appealing coverage decisions internally and externally
(including telephone numbers and mailing addresses of the appropriate
authority), and a description of any additional legal rights and
remedies available under section 502 of the Employee Retirement Income
Security Act of 1974 and applicable State law.
(13) Advance directives and organ donation.--A description
of procedures for advance directives and organ donation
decisions if the plan or issuer maintains such procedures.
(14) Information on plans and issuers.--The name, mailing
address, and telephone number or numbers of the plan
administrator and the issuer to be used by participants,
beneficiaries, and enrollees seeking information about plan or
coverage benefits and services, payment of a claim, or
authorization for services and treatment. Notice of whether the
benefits under the plan or coverage are provided under a
contract or policy of insurance issued by an issuer, or whether
benefits are provided directly by the plan sponsor who bears
the insurance risk.
(15) Translation services.--A summary description of any
translation or interpretation services (including the
availability of printed information in languages other than
English, audio tapes, or information in Braille) that are
available for non-English speakers and participants,
beneficiaries, and enrollees with communication disabilities
and a description of how to access these items or services.
(16) Accreditation information.--Any information that is
made public by accrediting organizations in the process of
accreditation if the plan or issuer is accredited, or any
additional quality indicators (such as the results of enrollee
satisfaction surveys) that the plan or issuer makes public or
makes available to participants, beneficiaries, and enrollees.
(17) Notice of requirements.--A description of any rights
of participants, beneficiaries, and enrollees that are
established by the Bipartisan Patient Protection Act of 2001
(excluding those described in paragraphs (1) through (16)) if
such sections apply. The description required under this
paragraph may be combined with the notices of the type
described in sections 711(d), 713(b), or 606(a)(1) of the
Employee Retirement Income Security Act of 1974 and with any
other notice provision that the appropriate Secretary
determines may be combined, so long as such combination does
not result in any reduction in the information that would
otherwise be provided to the recipient.
(18) Availability of additional information.--A statement
that the information described in subsection (c), and
instructions on obtaining such information (including telephone
numbers and, if available, Internet websites), shall be made
available upon request.
(c) Additional Information.--The informational materials to be
provided upon the request of a participant, beneficiary, or enrollee
shall include for each option available under a group health plan or
health insurance coverage the following:
(1) Status of providers.--The State licensure status of the
plan or issuer's participating health care professionals and
participating health care facilities, and, if available, the
education, training, specialty qualifications or certifications
of such professionals.
(2) Compensation methods.--A summary description by
category of the applicable methods (such as capitation, fee-
for-service, salary, bundled payments, per diem, or a
combination thereof) used for compensating prospective or
treating health care professionals (including primary care
providers and specialists) and facilities in connection with
the provision of health care under the plan or coverage.
(3) Prescription drugs.--Information about whether a
specific prescription medication is included in the formulary
of the plan or issuer, if the plan or issuer uses a defined
formulary.
(4) External appeals information.--Aggregate information on
the number and outcomes of external medical reviews, relative
to the sample size (such as the number of covered lives) under
the plan or under the coverage of the issuer.
(d) Manner of Disclosure.--The information described in this
section shall be disclosed in an accessible medium and format that is
calculated to be understood by an average participant or enrollee.
(e) Rules of Construction.--Nothing in this section shall be
construed to prohibit a group health plan, or a health insurance issuer
in connection with health insurance coverage, from--
(1) distributing any other additional information
determined by the plan or issuer to be important or necessary
in assisting participants, beneficiaries, and enrollees in the
selection of a health plan or health insurance coverage; and
(2) complying with the provisions of this section by
providing information in brochures, through the Internet or
other electronic media, or through other similar means, so long
as--
(A) the disclosure of such information in such form
is in accordance with requirements as the appropriate
Secretary may impose, and
(B) in connection with any such disclosure of
information through the Internet or other electronic
media--
(i) the recipient has affirmatively
consented to the disclosure of such information
in such form,
(ii) the recipient is capable of accessing
the information so disclosed on the recipient's
individual workstation or at the recipient's
home,
(iii) the recipient retains an ongoing
right to receive paper disclosure of such
information and receives, in advance of any
attempt at disclosure of such information to
him or her through the Internet or other
electronic media, notice in printed form of
such ongoing right and of the proper software
required to view information so disclosed, and
(iv) the plan administrator appropriately
ensures that the intended recipient is
receiving the information so disclosed and
provides the information in printed form if the
information is not received.
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
with respect to 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 a particular benefit or service 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
section 1842(c)(2) of the Social Security Act (42 U.S.C. 1395u(c)(2)).
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) 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.
(2) 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.
(3) 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, except that such term
includes a employee welfare benefit plan treated as a group
health plan under section 732(d) of such Act or defined as such
a plan under section 607(1) of such Act.
(4) 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.
(5) 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.
(6) 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.
(7) 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.
(8) 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.
(9) 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.
(10) Terms and conditions.--The term ``terms and
conditions'' includes, with respect to a group health plan or
health insurance coverage, requirements imposed under this
title with respect to the plan or coverage.
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.
(3) Construction.--In applying this section, a State law
that provides for equal access to, and availability of, all
categories of licensed health care providers and services shall
not be treated as preventing the application of any requirement
of this title.
(b) Application of Substantially Equivalent State Laws.--
(1) In general.--In the case of a State law that imposes,
with respect to health insurance coverage offered by a health
insurance issuer and with respect to a group health plan that
is a non-Federal governmental plan, a requirement that is
substantially equivalent (within the meaning of subsection (c))
to a patient protection requirement (as defined in paragraph
(3)) and does not prevent the application of other requirements
under this Act (except in the case of other substantially
equivalent requirements), in applying the requirements of this
title under section 2707 and 2753 (as applicable) of the Public
Health Service Act (as added by title II), subject to
subsection (a)(2)--
(A) the State law shall not be treated as being
superseded under subsection (a); and
(B) the State law shall apply instead of the
patient protection requirement otherwise applicable
with respect to health insurance coverage and non-
Federal governmental plans.
(2) Limitation.--In the case of a group health plan covered
under title I of the Employee Retirement Income Security Act of
1974, paragraph (1) shall be construed to apply only with
respect to the health insurance coverage (if any) offered in
connection with the plan.
(3) Patient protection requirement defined.--For purposes
of this section, the term ``patient protection requirement''
means a requirement under this title, and includes (as a single
requirement) a group or related set of requirements under a
section or similar unit under this title.
(c) Determinations of Substantial Equivalence.--
(1) Certification by states.--A State may submit to the
Secretary a certification that a State law provides for patient
protections that are at least substantially equivalent to one
or more patient protection requirements. Such certification
shall be accompanied by such information as may be required to
permit the Secretary to make the determination described in
paragraph (2)(A).
(2) Review.--
(A) In general.--The Secretary shall promptly
review a certification submitted under paragraph (1)
with respect to a State law to determine if the State
law provides for at least substantially equivalent and
effective patient protections to the patient protection
requirement (or requirements) to which the law relates.
(B) Approval deadlines.--
(i) Initial review.--Such a certification
is considered approved unless the Secretary
notifies the State in writing, within 90 days
after the date of receipt of the certification,
that the certification is disapproved (and the
reasons for disapproval) or that specified
additional information is needed to make the
determination described in subparagraph (A).
(ii) Additional information.--With respect
to a State that has been notified by the
Secretary under clause (i) that specified
additional information is needed to make the
determination described in subparagraph (A),
the Secretary shall make the determination
within 60 days after the date on which such
specified additional information is received by
the Secretary.
(3) Approval.--
(A) In general.--The Secretary shall approve a
certification under paragraph (1) unless--
(i) the State fails to provide sufficient
information to enable the Secretary to make a
determination under paragraph (2)(A); or
(ii) the Secretary determines that the
State law involved does not provide for patient
protections that are at least substantially
equivalent to and as effective as the patient
protection requirement (or requirements) to
which the law relates.
(B) State challenge.--A State that has a
certification disapproved by the Secretary under
subparagraph (A) may challenge such disapproval in the
appropriate United States district court.
(4) Construction.--Nothing in this subsection shall be
construed as preventing the certification (and approval of
certification) of a State law under this subsection solely
because it provides for greater protections for patients than
those protections otherwise required to establish substantial
equivalence.
(d) 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
provided under the terms and conditions 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 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) allows access to any provider that is lawfully
authorized to provide the covered services and that
agrees 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 for any health
care 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.
SEC. 156. INCORPORATION INTO PLAN OR COVERAGE DOCUMENTS.
The requirements of this title with respect to a group health plan
or health insurance coverage are deemed to be incorporated into, and
made a part of, such plan or the policy, certificate, or contract
providing such coverage and are enforceable under law as if directly
included in the documentation of such plan or such policy, certificate,
or contract.
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.
``Each group health plan shall comply with patient protection
requirements under title I of the Bipartisan Patient Protection Act of
2001, 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) 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.
``Each health insurance issuer shall comply with patient protection
requirements under title I of the Bipartisan Patient Protection Act of
2001 with respect to individual health insurance coverage it offers,
and such requirements shall be deemed to be incorporated into this
subsection.''.
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 Bipartisan Patient Protection Act of 2001 (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
Bipartisan Patient Protection Act of 2001 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 111 (relating to consumer choice
option).
``(B) Section 112 (relating to choice of health
care professional).
``(C) Section 113 (relating to access to emergency
care).
``(D) Section 114 (relating to timely access to
specialists).
``(E) Section 115 (relating to patient access to
obstetrical and gynecological care).
``(F) Section 116 (relating to access to pediatric
care).
``(G) Section 117 (relating to continuity of care),
but only insofar as a replacement issuer assumes the
obligation for continuity of care.
``(H) Section 118 (relating to access to needed
prescription drugs).
``(I) Section 119 (relating to coverage for
individuals participating in approved clinical trials).
``(J) Section 120 (relating to required coverage
for minimum hospital stay for mastectomies and lymph
node dissections for the treatment of breast cancer and
coverage for secondary consultations).
``(K) Section 134 (relating to payment of claims).
``(2) Information.--With respect to information required to
be provided or made available under section 121 of the
Bipartisan Patient Protection Act of 2001, 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) Internal appeals.--With respect to the internal
appeals process required to be established under section 103 of
such Act, 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 104 of such Act, 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
of the Bipartisan Patient Protection Act of 2001, 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) Treatment of substantially equivalent state laws.--
For purposes of applying this subsection, any reference in this
subsection to a requirement in a section or other provision in
the Bipartisan Patient Protection Act of 2001 with respect to a
health insurance issuer is deemed to include a reference to a
requirement under a State law that is substantially equivalent
(as determined under section 152(c) of such Act) to the
requirement in such section or other provisions.
``(8) Application to certain prohibitions against
retaliation.--With respect to compliance with the requirements
of section 135(b)(1) of the Bipartisan Patient Protection Act
of 2001, 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
Bipartisan Patient Protection Act of 2001 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 shall issue
regulations to coordinate the requirements on group health plans and
health insurance issuers under this section with the requirements
imposed under the other provisions of this title. In order to reduce
duplication and clarify the rights of participants and beneficiaries
with respect to information that is required to be provided, such
regulations shall coordinate the information disclosure requirements
under section 121 of the Bipartisan Patient Protection Act of 2001 with
the reporting and disclosure requirements imposed under part 1, so long
as such coordination does not result in any reduction in the
information that would otherwise be provided to participants and
beneficiaries.''.
(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
Bipartisan Patient Protection Act of 2001, and compliance with
regulations promulgated by the Secretary, 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. AVAILABILITY OF CIVIL REMEDIES.
(a) Availability of Federal Civil Remedies in Cases Not Involving
Medically Reviewable Decisions.--
(1) In general.--Section 502 of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1132) is amended by
adding at the end the following new subsection:
``(n) Cause of Action Relating to Provision of Health Benefits.--
``(1) In general.--In any case in which--
``(A) a person who is a fiduciary of a group health
plan, a health insurance issuer offering health
insurance coverage in connection with the plan, or an
agent of the plan, issuer, or plan sponsor--
``(i) upon consideration of a claim for
benefits of a participant or beneficiary under
section 102 of the Bipartisan Patient
Protection Act of 2001 (relating to procedures
for initial claims for benefits and prior
authorization determinations) or upon review of
a denial of such a claim under section 103 of
such Act (relating to internal appeal of a
denial of a claim for benefits), fails to
exercise ordinary care in making a decision--
``(I) regarding whether an item or
service is covered under the terms and
conditions of the plan or coverage,
``(II) regarding whether an
individual is a participant or
beneficiary who is enrolled under the
terms and conditions of the plan or
coverage (including the applicability
of any waiting period under the plan or
coverage), or
``(III) as to the application of
cost-sharing requirements or the
application of a specific exclusion or
express limitation on the amount,
duration, or scope of coverage of items
or services under the terms and
conditions of the plan or coverage, or
``(ii) otherwise fails to exercise ordinary
care in the performance of a duty under the
terms and conditions of the plan with respect
to a participant or beneficiary, and
``(B) such failure is a proximate cause of personal
injury to, or the death of, the participant or
beneficiary,
such person shall be liable to the participant or beneficiary
(or the estate of such participant or beneficiary) for economic
and noneconomic damages (but not exemplary or punitive damages)
in connection with such personal injury or death.
``(2) Cause of action must not involve medically reviewable
decision.--
``(A) In general.--A cause of action is established
under paragraph (1)(A) only if the decision referred to
in clause (i) or the failure described in clause (ii)
does not include a medically reviewable decision.
``(B) Medically reviewable decision.--For purposes
of subparagraph (A), the term `medically reviewable
decision' means a denial of a claim for benefits under
the plan which is described in section 104(d)(2) of the
Bipartisan Patient Protection Act of 2001 (relating to
medically reviewable decisions).
``(3) Definitions.--For purposes of this subsection.--
``(A) Ordinary care.--The term `ordinary care'
means--
``(i) with respect to a determination on a
claim for benefits, that degree of care, skill,
and diligence that a reasonable and prudent
individual would exercise in making a fair
determination on a claim for benefits of like
kind to the claim involved; and
``(ii) with respect to the performance of a
duty, that degree of care, skill, and diligence
that a reasonable and prudent individual would
exercise in performing the duty or a duty of
like character.
``(B) Personal injury.--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.
``(C) Claim for benefits; denial.--The terms `claim
for benefits' and `denial of a claim for benefits' have
the meanings provided such terms in section 102(e) of
the Bipartisan Patient Protection Act of 2001.
``(D) Terms and conditions.--The term `terms and
conditions' includes, with respect to a group health
plan or health insurance coverage, requirements imposed
under title I of the Bipartisan Patient Protection Act
of 2001 or under part 6 or 7.
``(E) Group health plan and other related terms.--
The provisions of sections 732(d) and 733 apply for
purposes of this subsection in the same manner as they
apply for purposes of part 7, except that the term
`group health plan' includes a group health plan (as
defined in section 607(1)).
``(4) Exclusion of employers and other plan sponsors.--
``(A) Causes of action against employers and plan
sponsors precluded.--Subject to subparagraph (B),
paragraph (1)(A) does not authorize a cause of action
against an employer or other plan sponsor maintaining
the plan (or against an employee of such an employer or
sponsor acting within the scope of employment).
``(B) Certain causes of action permitted.--
Notwithstanding subparagraph (A), a cause of action may
arise against an employer or other plan sponsor (or
against an employee of such an employer or sponsor
acting within the scope of employment)--
``(i) under clause (i) of paragraph (1)(A),
to the extent there was direct participation by
the employer or other plan sponsor (or
employee) in the decision of the plan under
section 102 of the Bipartisan Patient
Protection Act of 2001 upon consideration of a
claim for benefits or under section 103 of such
Act upon review of a denial of a claim for
benefits, or
``(ii) under clause (ii) of paragraph
(1)(A), to the extent there was direct
participation by the employer or other plan
sponsor (or employee) in the failure described
in such clause.
``(C) Direct participation.--
``(i) Direct participation in decisions.--
For purposes of subparagraph (B), the term
`direct participation' means, in connection
with a decision described in clause (i) of
paragraph (1)(A) or a failure described in
clause (ii) of such paragraph, the actual
making of such decision or the actual exercise
of control in making such decision or in the
conduct constituting the failure.
``(ii) Rules of construction.--For purposes
of clause (i), the employer or plan sponsor (or
employee) shall not be construed to be engaged
in direct participation because of any form of
decisionmaking or other conduct that is merely
collateral or precedent to the decision
described in clause (i) of paragraph (1)(A) on
a particular claim for benefits of a
participant or beneficiary or that is merely
collateral or precedent to the conduct
constituting a failure described in clause (ii)
of paragraph (1)(A) with respect to a
particular participant or beneficiary,
including (but not limited to)--
``(I) any participation by the
employer or other plan sponsor (or
employee) in the selection of the group
health plan or health insurance
coverage involved or the third party
administrator or other agent;
``(II) any engagement by the
employer or other plan sponsor (or
employee) in any cost-benefit analysis
undertaken in connection with the
selection of, or continued maintenance
of, the plan or coverage involved;
``(III) any participation by the
employer or other plan sponsor (or
employee) in the process of creating,
continuing, modifying, or terminating
the plan or any benefit under the plan,
if such process was not substantially
focused solely on the particular
situation of the participant or
beneficiary referred to in paragraph
(1)(A); and
``(IV) any participation by the
employer or other plan sponsor (or
employee) in the design of any benefit
under the plan, including the amount of
copayment and limits connected with
such benefit.
``(iv) Irrelevance of certain collateral
efforts made by employer or plan sponsor.--For
purposes of this subparagraph, an employer or
plan sponsor shall not be treated as engaged in
direct participation in a decision with respect
to any claim for benefits or denial thereof in
the case of any particular participant or
beneficiary solely by reason of--
``(I) any efforts that may have
been made by the employer or plan
sponsor to advocate for authorization
of coverage for that or any other
participant or beneficiary (or any
group of participants or
beneficiaries), or
``(II) any provision that may have
been made by the employer or plan
sponsor for benefits which are not
covered under the terms and conditions
of the plan for that or any other
participant or beneficiary (or any
group of participants or
beneficiaries).
``(5) Requirement of exhaustion.--
``(A) In general.--Except as provided in this
paragraph, a cause of action may not be brought under
paragraph (1) in connection with any denial of a claim
for benefits of any individual until all administrative
processes under sections 102 and 103 of the Bipartisan
Patient Protection Act of 2001 (if applicable) have
been exhausted.
``(B) Late manifestation of injury.--The
requirements under subparagraph (A) for a cause of
action in connection with any denial of a claim for
benefits shall be deemed satisfied, notwithstanding any
failure to timely commence review under section 103
with respect to the denial, if the personal injury is
first known (or first reasonably should have been
known) to the individual (or the death occurs) after
the latest date by which the applicable requirements of
subparagraph (A) can be met in connection with such
denial.
``(C) Occurrence of immediate and irreparable harm
or death prior to completion of process.--
``(i) In general.--The requirements of
subparagraph (A) shall not apply if the action
involves an allegation that immediate and
irreparable harm or death was, or would be,
caused by the denial of a claim for benefits
prior to the completion of the administrative
processes referred to in subparagraph (A) with
respect to such denial.
``(ii) Construction.--Nothing in clause (i)
shall be construed to preclude--
``(I) continuation of such
processes to their conclusion if so
moved by any party, and
``(II) consideration in such action
of the final decisions issued in such
processes.
``(iii) Definition.--In clause (i), the
term `irreparable harm', with respect to an
individual, means an injury or condition that,
regardless of whether the individual receives
the treatment that is the subject of the
denial, cannot be repaired in a manner that
would restore the individual to the
individual's pre-injured condition.
``(D) Receipt of benefits during appeals process.--
Receipt by the participant or beneficiary of the
benefits involved in the claim for benefits during the
pendency of any administrative processes referred to in
subparagraph (A) or of any action commenced under this
subsection--
``(i) shall not preclude continuation of
all such administrative processes to their
conclusion if so moved by any party, and
``(ii) shall not preclude any liability
under subsection (a)(1)(C) and this subsection
in connection with such claim.
The court in any action commenced under this subsection
shall take into account any receipt of benefits during
such administrative processes or such action in
determining the amount of the damages awarded.
``(6) Statutory damages.--
``(A) In general.--The remedies set forth in this
subsection (n) shall be the exclusive remedies for
causes of action brought under this subsection.
``(B) Assessment of civil penalties.--In addition
to the remedies provided for in paragraph (1) (relating
to the failure to provide contract benefits in
accordance with the plan), a civil assessment, in an
amount not to exceed $5,000,000, payable to the
claimant may be awarded in any action under such
paragraph if the claimant establishes by clear and
convincing evidence that the alleged conduct carried
out by the defendant demonstrated bad faith and
flagrant disregard for the rights of the participant or
beneficiary under the plan and was a proximate cause of
the personal injury or death that is the subject of the
claim.
``(7) Limitation of action.--Paragraph (1) shall not apply
in connection with any action commenced after 3 years after the
later of--
``(A) the date on which the plaintiff first knew,
or reasonably should have known, of the personal injury
or death resulting from the failure described in
paragraph (1), or
``(B) the date as of which the requirements of
paragraph (5) are first met.
``(8) Tolling provision.--The statute of limitations for
any cause of action arising under State law relating to a
denial of a claim for benefits that is the subject of an action
brought in Federal court under this subsection shall be tolled
until such time as the Federal court makes a final disposition,
including all appeals, of whether such claim should properly be
within the jurisdiction of the Federal court. The tolling
period shall be determined by the applicable Federal or State
law, whichever period is greater.
``(9) Purchase of insurance to cover liability.--Nothing in
section 410 shall be construed to preclude the purchase by a
group health plan of insurance to cover any liability or losses
arising under a cause of action under subsection (a)(1)(C) and
this subsection.
``(10) Exclusion of directed recordkeepers.--
``(A) In general.--Subject to subparagraph (C),
paragraph (1) shall not apply with respect to a
directed recordkeeper in connection with a group health
plan.
``(B) Directed recordkeeper.--For purposes of this
paragraph, the term `directed recordkeeper' means, in
connection with a group health plan, a person engaged
in directed recordkeeping activities pursuant to the
specific instructions of the plan or the employer or
other plan sponsor, including the distribution of
enrollment information and distribution of disclosure
materials under this Act or title I of the Bipartisan
Patient Protection Act of 2001 and whose duties do not
include making decisions on claims for benefits.
``(C) Limitation.--Subparagraph (A) does not apply
in connection with any directed recordkeeper to the
extent that the directed recordkeeper fails to follow
the specific instruction of the plan or the employer or
other plan sponsor.
``(11) No effect on state law.--No provision of State law
(as defined in section 514(c)(1)) shall be treated as
superseded or otherwise altered, amended, modified,
invalidated, or impaired by reason of the provisions of
subsection (a)(1)(C) and this subsection.''.
(2) Conforming amendment.--Section 502(a)(1) of such Act
(29 U.S.C. 1132(a)(1)) is amended--
(A) by striking ``or'' at the end of subparagraph
(A);
(B) in subparagraph (B), by striking ``plan;'' and
inserting ``plan, or''; and
(C) by adding at the end the following new
subparagraph:
``(C) for the relief provided for in subsection (n)
of this section.''.
(b) Rules Relating to ERISA Preemption.--Section 514 of the
Employee Retirement Income Security Act of 1974 (29 U.S.C. 1144) is
amended--
(1) by redesignating subsection (d) as subsection (f); and
(2) by inserting after subsection (c) the following new
subsections:
``(d) Preemption Not To Apply to Causes of Action under State Law
Involving Medically Reviewable Decision.--
``(1) Non-preemption of certain causes of action.--
``(A) In general.--Except as provided in this
subsection, nothing in this title (including section
502) shall be construed to supersede or otherwise
alter, amend, modify, invalidate, or impair any cause
of action under State law of a participant or
beneficiary under a group health plan (or the estate of
such a participant or beneficiary) to recover damages
resulting from personal injury or for wrongful death
against any person if such cause of action arises by
reason of a medically reviewable decision.
``(B) Medically reviewable decision.--For purposes
of subparagraph (A), the term `medically reviewable
decision' means a denial of a claim for benefits under
the plan which is described in section 104(d)(2) of the
Bipartisan Patient Protection Act of 2001 (relating to
medically reviewable decisions).
``(C) Limitation on punitive damages.--
``(i) In general.--Except as provided in
clauses (ii) and (iii), with respect to a cause
of action described in subparagraph (A) brought
with respect to a participant or beneficiary,
State law is superseded insofar as it provides
any punitive, exemplary, or similar damages if,
as of the time of the personal injury or death,
all the requirements of the following sections
of the Bipartisan Patient Protection Act of
2001 were satisfied with respect to the
participant or beneficiary:
``(I) Section 102 (relating to
procedures for initial claims for
benefits and prior authorization
determinations).
``(II) Section 103 of such Act
(relating to internal appeals of claims
denials).
``(III) Section 104 of such Act
(relating to independent external
appeals procedures).
``(ii) Exception for certain actions for
wrongful death.--Clause (i) shall not apply
with respect to an action for wrongful death if
the applicable State law provides (or has been
construed to provide) for damages in such an
action which are only punitive or exemplary in
nature.
``(iii) Exception for willful or wanton
disregard for the rights or safety of others.--
Clause (i) shall not apply with respect to any
cause of action described in subparagraph (A)
if, in such action, the plaintiff establishes
by clear and convincing evidence that conduct
carried out by the defendant with willful or
wanton disregard for the rights or safety of
others was a proximate cause of the personal
injury or wrongful death that is the subject of
the action.
``(2) Definitions.--For purposes of this subsection and
subsection (e)--
``(A) Group health plan and other related terms.--
The provisions of sections 732(d) and 733 apply for
purposes of this subsection in the same manner as they
apply for purposes of part 7, except that the term
`group health plan' includes a group health plan (as
defined in section 607(1)).
``(B) Personal injury.--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.
``(C) Claim for benefit; denial.--The terms `claim
for benefits' and `denial of a claim for benefits'
shall have the meaning provided such terms under
section 102(e) of the Bipartisan Patient Protection Act
of 2001.
``(3) Exclusion of employers and other plan sponsors.--
``(A) Causes of action against employers and plan
sponsors precluded.--Subject to subparagraph (B),
paragraph (1) does not apply with respect to--
``(i) any cause of action against an
employer or other plan sponsor maintaining the
plan (or against an employee of such an
employer or sponsor acting within the scope of
employment), or
``(ii) a right of recovery, indemnity, or
contribution by a person against an employer or
other plan sponsor (or such an employee) for
damages assessed against the person pursuant to
a cause of action to which paragraph (1)
applies.
``(B) Certain causes of action permitted.--
Notwithstanding subparagraph (A), paragraph (1) applies
with respect to any cause of action described in
paragraph (1) maintained by a participant or
beneficiary against an employer or other plan sponsor
(or against an employee of such an employer or sponsor
acting within the scope of employment)--
``(i) in the case of any cause of action
based on a decision of the plan under section
102 of the Bipartisan Patient Protection Act of
2001 upon consideration of a claim for benefits
or under section 103 of such Act upon review of
a denial of a claim for benefits, to the extent
there was direct participation by the employer
or other plan sponsor (or employee) in the
decision, or
``(ii) in the case of any cause of action
based on a failure to otherwise perform a duty
under the terms and conditions of the plan with
respect to a claim for benefits of a
participant or beneficiary, to the extent there
was direct participation by the employer or
other plan sponsor (or employee) in the
failure.
``(C) Direct participation.--
``(i) Direct participation in decisions.--
For purposes of subparagraph (B), the term
`direct participation' means, in connection
with a decision described in subparagraph
(B)(i) or a failure described in subparagraph
(B)(ii), the actual making of such decision or
the actual exercise of control in making such
decision or in the conduct constituting the
failure.
``(ii) Rules of construction.--For purposes
of clause (i), the employer or plan sponsor (or
employee) shall not be construed to be engaged
in direct participation because of any form of
decisionmaking or other conduct that is merely collateral or precedent
to the decision described in subparagraph (B)(i) on a particular claim
for benefits of a particular participant or beneficiary or that is
merely collateral or precedent to the conduct constituting a failure
described in subparagraph (B)(ii) with respect to a particular
participant or beneficiary, including (but not limited to)--
``(I) any participation by the
employer or other plan sponsor (or
employee) in the selection of the group
health plan or health insurance
coverage involved or the third party
administrator or other agent;
``(II) any engagement by the
employer or other plan sponsor (or
employee) in any cost-benefit analysis
undertaken in connection with the
selection of, or continued maintenance
of, the plan or coverage involved;
``(III) any participation by the
employer or other plan sponsor (or
employee) in the process of creating,
continuing, modifying, or terminating
the plan or any benefit under the plan,
if such process was not substantially
focused solely on the particular
situation of the participant or
beneficiary referred to in paragraph
(1)(A); and
``(IV) any participation by the
employer or other plan sponsor (or
employee) in the design of any benefit
under the plan, including the amount of
copayment and limits connected with
such benefit.
``(iii) Irrelevance of certain collateral
efforts made by employer or plan sponsor.--For
purposes of this subparagraph, an employer or
plan sponsor shall not be treated as engaged in
direct participation in a decision with respect
to any claim for benefits or denial thereof in
the case of any particular participant or
beneficiary solely by reason of--
``(I) any efforts that may have
been made by the employer or plan
sponsor to advocate for authorization
of coverage for that or any other
participant or beneficiary (or any
group of participants or
beneficiaries), or
``(II) any provision that may have
been made by the employer or plan
sponsor for benefits which are not
covered under the terms and conditions
of the plan for that or any other
participant or beneficiary (or any
group of participants or
beneficiaries).
``(4) Requirement of exhaustion.--
``(A) In general.--Except as provided in this
paragraph, paragraph (1) shall not apply with respect
to a cause of action described in such paragraph in
connection with any denial of a claim for benefits of
any individual until all administrative processes under
sections 102, 103, and 104 of the Bipartisan Patient
Protection Act of 2001 (if applicable) have been
exhausted.
``(B) Late manifestation of injury.--The
requirements under subparagraph (A) for a cause of
action in connection with any denial of a claim for
benefits shall be deemed satisfied, notwithstanding any
failure to timely commence review under section 103 or
104 with respect to the denial, if the personal injury
is first known (or first should have been known) to the
individual (or the death occurs) after the latest date
by which the applicable requirements of subparagraph
(A) can be met in connection with such denial.
``(C) Occurrence of immediate an irreparable harm
or death prior to completion of process.--
``(i) In general.--The requirements of
subparagraph (A) shall not apply if the action
involves an allegation that immediate and
irreparable harm or death was, or would be,
caused by the denial of a claim for benefits
prior to the completion of the administrative
processes referred to in subparagraph (A) with
respect to such denial.
``(ii) Construction.--Nothing in clause (i)
shall be construed to preclude--
``(I) continuation of such
processes to their conclusion if so
moved by any party, and
``(II) consideration in such action
of the final decisions issued in such
processes.
``(iii) Definition.--In clause (i), the
term `irreparable harm', with respect to an
individual, means an injury or condition that,
regardless of whether the individual receives
the treatment that is the subject of the
denial, cannot be repaired in a manner that
would restore the individual to the
individual's pre-injured condition.
``(D) Receipt of benefits during appeals process.--
Receipt by the participant or beneficiary of the
benefits involved in the claim for benefits during the
pendency of any administrative processes referred to in
subparagraph (A) or of any action commenced under this
subsection--
``(i) shall not preclude continuation of
all such administrative processes to their
conclusion if so moved by any party, and
``(ii) shall not preclude any liability
under subsection (a)(1)(C) and this subsection
in connection with such claim.
``(5) Tolling provision.--The statute of limitations for
any cause of action arising under section 502(n) relating to a
denial of a claim for benefits that is the subject of an action
brought in State court shall be tolled until such time as the
State court makes a final disposition, including all appeals,
of whether such claim should properly be within the
jurisdiction of the State court. The tolling period shall be
determined by the applicable Federal or State law, whichever
period is greater.
``(6) Exclusion of directed recordkeepers.--
``(A) In general.--Subject to subparagraph (C),
paragraph (1) shall not apply with respect to a
directed recordkeeper in connection with a group health
plan.
``(B) Directed recordkeeper.--For purposes of this
paragraph, the term `directed recordkeeper' means, in
connection with a group health plan, a person engaged
in directed recordkeeping activities pursuant to the
specific instructions of the plan or the employer or
other plan sponsor, including the distribution of
enrollment information and distribution of disclosure
materials under this Act or title I of the Bipartisan
Patient Protection Act of 2001 and whose duties do not include making
decisions on claims for benefits.
``(C) Limitation.--Subparagraph (A) does not apply
in connection with any directed recordkeeper to the
extent that the directed recordkeeper fails to follow
the specific instruction of the plan or the employer or
other plan sponsor.
``(7) Construction.--Nothing in this subsection shall be
construed as--
``(A) saving from preemption a cause of action
under State law for the failure to provide a benefit
for an item or service which is specifically excluded
under the group health plan involved, except to the
extent that--
``(i) the application or interpretation of
the exclusion involves a determination
described in section 104(d)(2) of the
Bipartisan Patient Protection Act of 2001, or
``(ii) the provision of the benefit for the
item or service is required under Federal law
or under applicable State law consistent with
subsection (b)(2)(B);
``(B) preempting a State law which requires an
affidavit or certificate of merit in a civil action;
``(C) affecting 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); or
``(D) affecting a cause of action under State law
other than a cause of action described in paragraph
(1)(A).
``(8) Purchase of insurance to cover liability.--Nothing in
section 410 shall be construed to preclude the purchase by a
group health plan of insurance to cover any liability or losses
arising under a cause of action described in paragraph (1)(A).
``(e) Rules of Construction Relating to Health Care.--Nothing in
this title shall be construed as--
``(1) affecting any State law relating to the practice of
medicine or the provision of medical care, or affecting any
action based upon such a State law,
``(2) superseding any State law permitted under section
152(b)(1)(A) of the Bipartisan Patient Protection Act of 2001,
or
``(3) affecting any applicable State law with respect to
limitations on monetary damages.''.
(c) Effective Date.--The amendments made by this section shall
apply to acts and omissions (from which a cause of action arises)
occurring on or after the date of the enactment of this Act.
SEC. 303. LIMITATIONS ON ACTIONS.
Section 502 of the Employee Retirement Income Security Act of 1974
(29 U.S.C. 1132) (as amended by section 302(a)) is amended further by
adding at the end the following new subsection:
``(o) Limitations on Actions Relating to Group Health Plans.--
``(1) In general.--Except as provided in paragraph (2), 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 Bipartisan Patient Protection Act
of 2001 (as incorporated under section 714).
``(2) Certain actions allowable.--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, 118(a)(3), 119, or 120 of
the Bipartisan Patient Protection Act of 2001 (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) Other provisions unaffected.--Nothing in this
subsection shall be construed as affecting subsections
(a)(1)(C) and (n) or section 514(d).
``(4) Enforcement by secretary unaffected.--Nothing in this
subsection shall be construed as affecting any action brought
by the Secretary.''.
TITLE IV--AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986
SEC. 401. APPLICATION TO GROUP HEALTH PLANS UNDER 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
patients' bill of rights.'';
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 Bipartisan Patient Protection Act of 2001 (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.''.
SEC. 402. CONFORMING ENFORCEMENT FOR WOMEN'S HEALTH AND CANCER RIGHTS.
Subchapter B of chapter 100 of the Internal Revenue Code of 1986,
as amended by section 401, is further amended--
(1) in the table of sections, by inserting after the item
relating to section 9813 the following new item:
``Sec. 9814. Standard relating to women's
health and cancer rights.'';
and
(2) by inserting after section 9813 the following:
``SEC. 9814. STANDARD RELATING TO WOMEN'S HEALTH AND CANCER RIGHTS.
``The provisions of section 713 of the Employee Retirement Income
Security Act of 1974 (as in effect as of the date of the enactment of
this section) shall apply to group health plans as if included in this
subchapter.''.
TITLE V--EFFECTIVE DATES; COORDINATION IN IMPLEMENTATION
SEC. 501. EFFECTIVE DATES.
(a) Group Health Coverage.--
(1) In general.--Subject to paragraph (2) and subsection
(d), the amendments made by sections 201(a), 301, 303, and 401
and 402 (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'').
(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 402 (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 division shall not be treated as a termination of
such collective bargaining agreement.
(b) Individual Health Insurance Coverage.--Subject to subsection
(d), 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.
(c) Treatment of Religious Nonmedical Providers.--
(1) In general.--Nothing in this Act (or the amendments
made thereby) shall be construed to--
(A) restrict or limit the right of group health
plans, and of health insurance issuers offering health
insurance coverage, to include as providers religious
nonmedical providers;
(B) require such plans or issuers to--
(i) utilize medically based eligibility
standards or criteria in deciding provider
status of religious nonmedical providers;
(ii) use medical professionals or criteria
to decide patient access to religious
nonmedical providers;
(iii) utilize medical professionals or
criteria in making decisions in internal or
external appeals regarding coverage for care by
religious nonmedical providers; or
(iv) compel a participant or beneficiary to
undergo a medical examination or test as a
condition of receiving health insurance
coverage for treatment by a religious
nonmedical provider; or
(C) require such plans or issuers to exclude
religious nonmedical providers because they do not
provide medical or other required data, if such data is
inconsistent with the religious nonmedical treatment or
nursing care provided by the provider.
(2) Religious nonmedical provider.--For purposes of this
subsection, the term ``religious nonmedical provider'' means a
provider who provides no medical care but who provides only
religious nonmedical treatment or religious nonmedical nursing
care.
(d) Transition for Notice Requirement.--The disclosure of
information required under section 121 of this Act shall first be
provided pursuant to--
(1) subsection (a) with respect to a group health plan that
is maintained as of the general effective date, not later than
30 days before the beginning of the first plan year to which
title I applies in connection with the plan under such
subsection; or
(2) subsection (b) with respect to a individual health
insurance coverage that is in effect as of the general
effective date, not later than 30 days before the first date as
of which title I applies to the coverage under such subsection.
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
division (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.
SEC. 503. SEVERABILITY.
If any provision of this Act, an amendment made by this Act, or the
application of such provision or amendment to any person or
circumstance is held to be unconstitutional, the remainder of this Act,
the amendments made by this Act, and the application of the provisions
of such to any person or circumstance shall not be affected thereby.
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