1.Short
title; table of contents
(a)This Act may be cited
as the Patients' Bill of Rights Act of
2005
.
(b)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.
Sec. 105. Health Care Consumer Assistance
Fund.
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. Treatment of excepted
benefits.
Sec. 155. Regulations.
Sec. 156. Incorporation into plan or
coverage documents.
Sec. 157. Preservation of
protections.
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.
Sec. 203. Cooperation between Federal and
State authorities.
Title III—Application of patient protection
standards to Federal health insurance programs
Sec. 301. Application of patient
protection standards to Federal health insurance programs.
Title IV—Amendments to the
Employee Retirement Income Security Act of
1974
Sec. 401. Application of patient
protection standards to group health plans and group health insurance coverage
under the Employee Retirement Income Security
Act of 1974.
Sec. 402. Availability of civil
remedies.
Sec. 403. Cooperation between Federal and
State authorities.
Title V—Amendments to the Internal Revenue
Code of 1986
Subtitle A—Application of Patient
Protection Provisions
Sec. 501. Application to group health
plans under the Internal Revenue Code of 1986.
Sec. 502. Conforming enforcement for
women’s health and cancer rights.
Subtitle B—Health Care Coverage Access
Tax Incentives
Sec. 511. Credit for health insurance
expenses of small businesses.
Sec. 512. Certain grants by private
foundations to qualified health benefit purchasing coalitions.
Sec. 513. State grant program for market
innovation.
Sec. 514. Grant program to facilitate
health benefits information for small employers.
Sec. 515. State grant program for market
innovation.
Title VI—Effective dates; coordination in
implementation
Sec. 601. Effective dates.
Sec. 602. Coordination in
implementation.
Sec. 603. Severability.
Title VII—Miscellaneous
provisions
Sec. 701. No impact on Social Security
Trust Fund.
<enum>I</enum><header>Improving managed
care</header>
<subtitle id="HC3F542D718BC4C84BF78883F003B22DC"><enum>A</enum><header>Utilization
review; claims; and internal and external appeals</header>
<section id="H982E52F4C42D44FEAB1C50E650BF52B4"><enum>101.</enum><header>Utilization
review activities</header>
<subsection id="HABC9AC09135C472993D2D6FE58E8DC8C"><enum>(a)</enum><header>Compliance with
requirements</header>
<paragraph id="H69F7E9D75BB6432283B98FD03777554C"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="HA85E30078BD645E986D55EE9F0755B6C"><enum>(2)</enum><header>Use of outside
agents</header><text>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.</text>
</paragraph><paragraph id="H794A8FE4BA52494DB4AD1556E688DAD7"><enum>(3)</enum><header>Utilization
review defined</header><text>For purposes of this section, the terms
<term>utilization review</term> and <term>utilization review activities</term>
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.</text>
</paragraph></subsection><subsection id="H30826CA9264C420AAA677336DA43AA99"><enum>(b)</enum><header>Written policies
and criteria</header>
<paragraph id="H2D51CBA25BE6414EA6F0DD00C79FF16"><enum>(1)</enum><header>Written
policies</header><text>A utilization review program shall be conducted
consistent with written policies and procedures that govern all aspects of the
program.</text>
</paragraph><paragraph id="H9BED53898A2C44499EB0949B056179A2"><enum>(2)</enum><header>Use of written
criteria</header>
<subparagraph id="H734282EEE4F04853990016C572E91C51"><enum>(A)</enum><header>In
general</header><text>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.</text>
</subparagraph><subparagraph id="H088F24C113F4413DA3DB126556B90340"><enum>(B)</enum><header>Continuing use
of standards in retrospective review</header><text>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.</text>
</subparagraph><subparagraph id="H6DDE83478C584D2BAC9068002EB93364"><enum>(C)</enum><header>Review of sample
of claims denials</header><text>Such a program shall provide for a periodic
evaluation of the clinical appropriateness of at least a sample of denials of
claims for benefits.</text>
</subparagraph></paragraph></subsection><subsection id="H68952AB4BB6B4523B4F80000B95644B0"><enum>(c)</enum><header>Conduct of
program activities</header>
<paragraph id="HD2042E4E5D2A4DD585F614E8FE006878"><enum>(1)</enum><header>Administration
by health care professionals</header><text>A utilization review program shall
be administered by qualified health care professionals who shall oversee review
decisions.</text>
</paragraph><paragraph id="HD403A83B2BE645F3818800364EF100DF"><enum>(2)</enum><header>Use of
qualified, independent personnel</header>
<subparagraph id="H5909271473144FB700FBF0C4A258D600"><enum>(A)</enum><header>In
general</header><text>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.</text>
</subparagraph><subparagraph id="HF7B224A544694C648500758CE7F3F467"><enum>(B)</enum><header>Prohibition of
contingent compensation arrangements</header><text>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.</text>
</subparagraph><subparagraph id="HE55667D52E2C43BAA062CD158FD26CAB"><enum>(C)</enum><header>Prohibition of
conflicts</header><text>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.</text>
</subparagraph></paragraph><paragraph id="H075F3CABE6034644A50035C6ADFC5EC2"><enum>(3)</enum><header>Accessibility of
review</header><text>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.</text>
</paragraph><paragraph id="H6057158F1EB74A58B0B28D92A555497E"><enum>(4)</enum><header>Limits on
frequency</header><text>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.</text>
</paragraph></subsection></section><section id="H931BFFCDC3AC41748346FAF4483DA01"><enum>102.</enum><header>Procedures for
initial claims for benefits and prior authorization determinations</header>
<subsection id="H4A09FB1BC09F4D459E83D7E601812DA"><enum>(a)</enum><header>Procedures of
initial claims for benefits</header>
<paragraph id="HA651A7D1055A4BBAB300858455ECF5F"><enum>(1)</enum><header>In
general</header><text>A group health plan, and a health insurance issuer
offering health insurance coverage, shall—</text>
<subparagraph id="HF57CDC88802448999415367C0597B61B"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="H0F0164D4F4C74DF19593148EE8A53929"><enum>(B)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="H7F99F854A46A4C478371C3BDC047CA11"><enum>(2)</enum><header>Access to
information</header>
<subparagraph id="HA7FA78149458415BAF538D33BA935FB9"><enum>(A)</enum><header>Timely provision
of necessary information</header><text>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.</text>
</subparagraph><subparagraph id="HB4A3E271A5E14F4FB4593E119528A7C9"><enum>(B)</enum><header>Limited effect
of failure on plan or issuer’s obligations</header><text>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.</text>
</subparagraph></paragraph><paragraph id="HED318C53B729409DB2C04F4F9C515DDA"><enum>(3)</enum><header>Oral
requests</header><text>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 claim for such
benefits without regard to whether and when a written confirmation of such
request is made.</text>
</paragraph></subsection><subsection id="H866BE66C5C284AEABA6FABAB6C66D974"><enum>(b)</enum><header>Timeline for
making determinations</header>
<paragraph id="HEC8349FAC5894DB693472100D702C90"><enum>(1)</enum><header>Prior
authorization determination</header>
<subparagraph id="H3D20163BEBEB46939FECB9B1B984016"><enum>(A)</enum><header>In
general</header><text>A group health plan, and a 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.</text>
</subparagraph><subparagraph id="H57C09D2C100A4F6A92AF005E01AA11F0"><enum>(B)</enum><header>Expedited
determination</header><text>Notwithstanding subparagraph (A), a group health
plan, and a 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.</text>
</subparagraph><subparagraph id="HFC99820F23F84026AB4C2F28A3B1EDF6"><enum>(C)</enum><header>Ongoing
care</header>
<clause id="HF09E12E730AF4F43A84660E8C4653D0"><enum>(i)</enum><header>Concurrent
review</header>
<subclause id="HE8E6947B0AA543DA95E773CBCD662971"><enum>(I)</enum><header>In
general</header><text>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.</text>
</subclause><subclause id="HADB938BFE12349989B43C8F604A771CE"><enum>(II)</enum><header>Contents of
notice</header><text>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.</text>
</subclause></clause><clause id="H8913FA2F12634896AFCF00AFFC89CF"><enum>(ii)</enum><header>Rule of
construction</header><text>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.</text>
</clause></subparagraph></paragraph><paragraph id="H0F4B71A1FC6A4C448B2CC9AA0A941E8"><enum>(2)</enum><header>Retrospective
determination</header><text>A group health plan, and a 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.</text>
</paragraph></subsection><subsection id="H3B9B2D406D2F4BFCB4D846688B246782"><enum>(c)</enum><header>Notice of a
denial of a claim for benefits</header><text>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).</text>
</subsection><subsection id="HF76DDA5432834702BF8F32422300D2F8"><enum>(d)</enum><header>Requirements of
notice of determinations</header><text>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
participant, beneficiary, or enrollee and shall include—</text>
<paragraph id="H902E24E711884A2B8839BE67E1CBDB36"><enum>(1)</enum><text>the specific
reasons for the determination (including a summary of the clinical or
scientific evidence used in making the determination);</text>
</paragraph><paragraph id="H587D367DB36A4B6B9E067DEAFE34EE8F"><enum>(2)</enum><text>the procedures for
obtaining additional information concerning the determination; and</text>
</paragraph><paragraph id="H36B40B924C9F4BAF8E4C82D571F7E53"><enum>(3)</enum><text>notification of the
right to appeal the determination and instructions on how to initiate an appeal
in accordance with section 103.</text>
</paragraph></subsection><subsection id="H02A0FE51E1E044848BC9D2561760176B"><enum>(e)</enum><header>Definitions</header><text>For
purposes of this part:</text>
<paragraph id="HF508D54D0F2B4BECB028B5F0006BDB05"><enum>(1)</enum><header>Authorized
representative</header><text>The term <term>authorized representative</term>
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.</text>
</paragraph><paragraph id="H8FD1D0D2D39F407997369D2BD4333B37"><enum>(2)</enum><header>Claim for
benefits</header><text>The term <term>claim for benefits</term> 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.</text>
</paragraph><paragraph id="H6AE460161042477E00FF1C791D38355F"><enum>(3)</enum><header>Denial of claim
for benefits</header><text>The term <term>denial</term> 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.</text>
</paragraph><paragraph id="H3F367A661B11428E95B28BBE2072C869"><enum>(4)</enum><header>Treating health
care professional</header><text>The term <term>treating health care
professional</term> 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.</text>
</paragraph></subsection></section><section id="H717328AA939D4717BF00E170A4DBFF87"><enum>103.</enum><header>Internal
appeals of claims denials</header>
<subsection id="HCD7F84BC25484D538686E883EABC8543"><enum>(a)</enum><header>Right to
internal appeal</header>
<paragraph id="H4054B2E982194B7499CE4EE9649D6D32"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="H866E9B9CB4E04EA1AE3BD8F053EE3240"><enum>(2)</enum><header>Time for
appeal</header>
<subparagraph id="H701D1F4F17634614AC3376F2DEED00D2"><enum>(A)</enum><header>In
general</header><text>A group health plan, and a 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.</text>
</subparagraph><subparagraph id="H2CF20F58E5C3419EB3008CDF7C024062"><enum>(B)</enum><header>Date of
denial</header><text>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.</text>
</subparagraph></paragraph><paragraph id="H415DED98CEE24F36B83F74A647D669F"><enum>(3)</enum><header>Failure to
Act</header><text>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.</text>
</paragraph><paragraph id="HA9140A4280F844A400EBF8235333EB73"><enum>(4)</enum><header>Plan waiver of
internal review</header><text>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.</text>
</paragraph></subsection><subsection id="H7055B6BB183D48D99D1D36464D93F237"><enum>(b)</enum><header>Timelines for
making determinations</header>
<paragraph id="H830175AF1A30437CA2F55FDBB9C82EFA"><enum>(1)</enum><header>Oral
requests</header><text>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.</text>
</paragraph><paragraph id="H882CEA7FC353495B86EA2349BC271D6E"><enum>(2)</enum><header>Access to
information</header>
<subparagraph id="H36FD0D22A712406692B4065430F16B4E"><enum>(A)</enum><header>Timely provision
of necessary information</header><text>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.</text>
</subparagraph><subparagraph id="HF811400B518F487EABD1E6C86BFE3993"><enum>(B)</enum><header>Limited effect
of failure on plan or issuer’s obligations</header><text>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.</text>
</subparagraph></paragraph><paragraph id="HE887E0F5D2234D669DB65A489D4E153"><enum>(3)</enum><header>Prior
authorization determinations</header>
<subparagraph id="HBF910C5213C34DA500AD631732DF3900"><enum>(A)</enum><header>In
general</header><text>Except as provided in this paragraph or paragraph (4), a
group health plan, and a 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.</text>
</subparagraph><subparagraph id="HC4F019DE515D4E359120BB396FE4B5FD"><enum>(B)</enum><header>Expedited
determination</header><text>Notwithstanding subparagraph (A), a group health
plan, and a 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.</text>
</subparagraph><subparagraph id="H9ABA4C754F3D430FAB7D774D68C1585C"><enum>(C)</enum><header>Ongoing care
determinations</header>
<clause id="H0FDDE01196E14995888521FB0792F02B"><enum>(i)</enum><header>In
general</header><text>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.</text>
</clause><clause id="H821C072AF00D4C7B82F2A8978D66FB2"><enum>(ii)</enum><header>Rule of
construction</header><text>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.</text>
</clause></subparagraph></paragraph><paragraph id="H6B109BF96DEC497D0068BF8C3B1D4ED6"><enum>(4)</enum><header>Retrospective
determination</header><text>A group health plan, and a health insurance issuer
offering health insurance coverage, shall make a retrospective determination on
an appeal of a denial 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.</text>
</paragraph></subsection><subsection id="H975B1533237A403F9ED972CB8E5100CE"><enum>(c)</enum><header>Conduct of
review</header>
<paragraph id="H625899B3865F4EA281F83752BA63BA00"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="HB1017CB56AA440B4AF54CA6127DA6771"><enum>(2)</enum><header>Peer review of
medical decisions by health care professionals</header><text>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—</text>
<subparagraph id="H4A857B72C4224479A4A1927CF23FE41E"><enum>(A)</enum><text>shall be made by a
physician (allopathic or osteopathic); or</text>
</subparagraph><subparagraph id="H3748C99201164419B99C70B0F1673D73"><enum>(B)</enum><text>in a claim for
benefits provided by a non-physician health professional, shall be made by
reviewer (or reviewers) including at least one practicing non-physician health
professional of the same or similar specialty;</text>
</subparagraph><continuation-text continuation-text-level="paragraph">with
appropriate expertise (including, in the case of a child, appropriate pediatric
expertise) and acting within the appropriate scope of practice within the State
in which the service is provided or rendered, who was not involved in the
initial determination.</continuation-text></paragraph></subsection><subsection id="HEF7C2F70A21345FDB071A391DAAFA93"><enum>(d)</enum><header>Notice of
determination</header>
<paragraph id="HE56C3B3C60B7457C9C00930675CE7D81"><enum>(1)</enum><header>In
general</header><text>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).</text>
</paragraph><paragraph id="H13DA496DE56E42CBA100B099EE76D12B"><enum>(2)</enum><header>Final
determination</header><text>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.</text>
</paragraph><paragraph id="HC6B6C42D8CE14D7D8D23175B51FDD93D"><enum>(3)</enum><header>Requirements of
notice</header><text>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 participant,
beneficiary, or enrollee and shall include—</text>
<subparagraph id="H2C36F502AC1E4DDBAD38FCA634A93913"><enum>(A)</enum><text>the specific
reasons for the determination (including a summary of the clinical or
scientific evidence used in making the determination);</text>
</subparagraph><subparagraph id="H1BA0437F5F9748838CA3189759E692C"><enum>(B)</enum><text>the procedures for
obtaining additional information concerning the determination; and</text>
</subparagraph><subparagraph id="H7CEEBB10ED7D422FAA325FF77F4D3093"><enum>(C)</enum><text>notification of
the right to an independent external review under section 104 and instructions
on how to initiate such a review.</text>
</subparagraph></paragraph></subsection></section><section id="H01508C9F7F9B438793C45B3472BC04F7"><enum>104.</enum><header>Independent
external appeals procedures</header>
<subsection id="H653B3735AC9A4755BBB4C74C1764C6D8"><enum>(a)</enum><header>Right to
external appeal</header><text>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.</text>
</subsection><subsection id="H15B72A64C2934B66BD3F18F770465EA4"><enum>(b)</enum><header>Initiation of
the independent external review process</header>
<paragraph id="H79E222C9DD80485EB491D8AF5F99009F"><enum>(1)</enum><header>Time to
file</header><text>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.</text>
</paragraph><paragraph id="H68F457C1FC9542670013DFB87CECB250"><enum>(2)</enum><header>Filing of
request</header>
<subparagraph id="HDAF3DDA2086F4A9C84FDD1758F244BD"><enum>(A)</enum><header>In
general</header><text>Subject to the succeeding provisions of this subsection,
a group health plan, or health insurance issuer offering health insurance
coverage, may—</text>
<clause id="H733759147B46420E9DFB42D45DDAC902"><enum>(i)</enum><text>except as provided
in subparagraph (B)(i), require that a request for review be in writing;</text>
</clause><clause id="H54F7B17B83944A22B5F3E960DC951046"><enum>(ii)</enum><text>limit the filing
of such a request to the participant, beneficiary, or enrollee involved (or an
authorized representative);</text>
</clause><clause id="H841B086EC3864586B534F4AEB6472B10"><enum>(iii)</enum><text>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;</text>
</clause><clause id="H9D0A4DF138654711BC7B00CEDADCE00"><enum>(iv)</enum><text>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</text>
</clause><clause id="HF214EE805C5F44CA9D00D3AC104B77F8"><enum>(v)</enum><text>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.</text>
</clause></subparagraph><subparagraph id="HC29C52DD814A4B47ABF7D91C97D750D"><enum>(B)</enum><header>Requirements and
exception relating to general rule</header>
<clause id="H3F25806D80C84189A97500009B2EA288"><enum>(i)</enum><header>Oral requests
permitted in expedited or concurrent cases</header><text>In the case of an
expedited or concurrent external review as provided for under subsection (e),
the request for such review 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 a review without
regard to whether and when a written confirmation of such request is
made.</text>
</clause><clause id="H090006C425984E4F998C4D86D06353D5"><enum>(ii)</enum><header>Exception to
filing fee requirement</header>
<subclause id="H2525E57DDE124EB89574E253CD513FDD"><enum>(I)</enum><header>Indigency</header><text>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).</text>
</subclause><subclause id="HC4546E5F1F5F466680DCAADDE9D100EE"><enum>(II)</enum><header>Fee not
required</header><text>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).</text>
</subclause><subclause id="HACE3CAC3FE9B4850ABBDD582DE72B2CC"><enum>(III)</enum><header>Refunding of
fee</header><text>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.</text>
</subclause><subclause id="HA1B356B38AFF425D833288C84C5FCA34"><enum>(IV)</enum><header>Collection of
filing fee</header><text>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.</text>
</subclause></clause></subparagraph></paragraph></subsection><subsection id="H418D1B4D50B04ADAB2A407D5E300FB79"><enum>(c)</enum><header>Referral to
qualified external review entity upon request</header>
<paragraph id="H49F05D91A674433FAF91CB47524CB7AC"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="H6B702095852A4C8085EF6C941E18D86B"><enum>(2)</enum><header>Access to plan
or issuer and health professional information</header><text>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.</text>
</paragraph><paragraph id="HE7548A212240469DB6943F4727974C87"><enum>(3)</enum><header>Screening of
requests by qualified external review entities</header>
<subparagraph id="H1AC60F1609F54023BAB042D21BA7514E"><enum>(A)</enum><header>In
general</header><text>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—</text>
<clause id="HAE4B9F8043F74535A69993FED2A73742"><enum>(i)</enum><text>any
of the conditions described in clauses (ii) or (iii) of subsection (b)(2)(A)
have not been met;</text>
</clause><clause id="H442411363E774F1BA98DE01201F280DE"><enum>(ii)</enum><text>the
denial of the claim for benefits does not involve a medically reviewable
decision under subsection (d)(2);</text>
</clause><clause id="H0119B477ED3B4336B898A17B6017374"><enum>(iii)</enum><text>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</text>
</clause><clause id="H16BCF99666D94707A30672006E753928"><enum>(iv)</enum><text>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).</text>
</clause><continuation-text continuation-text-level="subparagraph">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).</continuation-text></subparagraph><subparagraph id="HDC708261410E4A019D832B609040EBA7"><enum>(B)</enum><header>Process for
making determinations</header>
<clause id="H7175683C73834416838B27BFE54230DE"><enum>(i)</enum><header>No
deference to prior determinations</header><text>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).</text>
</clause><clause id="HE8D5B8B64BEE46FC819D51A66D70EBF"><enum>(ii)</enum><header>Use of
appropriate personnel</header><text>A qualified external review entity shall
use appropriately qualified personnel to make determinations under this
section.</text>
</clause></subparagraph><subparagraph id="HBC6C9860195F427FBFA0AEE8C1E7197"><enum>(C)</enum><header>Notices and
general timelines for determination</header>
<clause id="H7EBF21F3457342A999CBB4406BB0094"><enum>(i)</enum><header>Notice in case of
denial of referral</header><text>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—</text>
<subclause id="H1F7A06C76C4B4E898BAA0030E5DC4300"><enum>(I)</enum><text>shall be written
(and, in addition, may be provided orally) in a manner calculated to be
understood by a participant or enrollee;</text>
</subclause><subclause id="HA66AE5E06C7D4C8697C6946C82FED017"><enum>(II)</enum><text>shall include the
reasons for the determination;</text>
</subclause><subclause id="HF1F8838494AD4598A9A5FFF2B737FC39"><enum>(III)</enum><text>include any
relevant terms and conditions of the plan or coverage; and</text>
</subclause><subclause id="H948FDC7BF5B34BA189341F22769BDF7"><enum>(IV)</enum><text>include a
description of any further recourse available to the individual.</text>
</subclause></clause><clause id="H8B87E392ECF2499B8876019000003FFF"><enum>(ii)</enum><header>General
timeline for determinations</header><text>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.</text>
</clause></subparagraph></paragraph></subsection><subsection id="HCD42BAEA14FB4DC181C35BDDC6E876C8"><enum>(d)</enum><header>Independent
medical review</header>
<paragraph id="H29A2BA3044F64FBCAE9501CBB70830EF"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="H0F4858C26BFE42558597AEAAEA028F3"><enum>(2)</enum><header>Medically
reviewable decisions</header><text>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:</text>
<subparagraph id="H64A34744AD2744449CCF7FB563D71CF1"><enum>(A)</enum><header>Denials based on
medical necessity and appropriateness</header><text>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.</text>
</subparagraph><subparagraph id="H1C6689E33E7F4F4F87FDE4060063E21"><enum>(B)</enum><header>Denials based on
experimental or investigational treatment</header><text>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.</text>
</subparagraph><subparagraph id="H46A9F36D054E4F77AC01783020259FA2"><enum>(C)</enum><header>Denials
otherwise based on an evaluation of medical facts</header><text>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.</text>
</subparagraph></paragraph><paragraph id="H5774D4C4DF2A40E4860242835964CA2E"><enum>(3)</enum><header>Independent
medical review determination</header>
<subparagraph id="H5560F65DDB0D427390BFB475F3758DF1"><enum>(A)</enum><header>In
general</header><text>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.</text>
</subparagraph><subparagraph id="HFE7CFD3185BF409DBC29E6D3000000D6"><enum>(B)</enum><header>Standard for
determination</header><text>The independent medical reviewer’s determination
relating to the medical necessity and appropriateness, or the experimental or
investigational nature, or the evaluation of the medical facts, of the item,
service, or condition involved 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.</text>
</subparagraph><subparagraph id="HEF3C5AB983DC47F4A4161E97698BEACF"><enum>(C)</enum><header>No coverage for
excluded benefits</header><text>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)). Notwithstanding any other
provision of this Act, any exclusion of an exact medical procedure, any exact
time limit on the duration or frequency of coverage, and any exact dollar limit
on the amount of coverage that is specifically enumerated and defined (in the
plain language of the plan or coverage documents) under the plan or coverage
offered by a group health plan or health insurance issuer offering health
insurance coverage and that is disclosed under section 121(b)(1) shall be
considered to govern the scope of the benefits that may be required:
<italic>Provided, </italic>That the terms and conditions of the plan or
coverage relating to such an exclusion or limit are in compliance with the
requirements of law.</text>
</subparagraph><subparagraph id="H6C22C7BB26E94AE5B58348CBE900FF8C"><enum>(D)</enum><header>Evidence and
information to be used in medical reviews</header><text>In making a
determination under this subsection, the independent medical reviewer shall
also consider appropriate and available evidence and information, including the
following:</text>
<clause id="HA2EB96933BF440FA8829AEB68637DAFF"><enum>(i)</enum><text>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.</text>
</clause><clause id="H19657BCDE28E486AB49B63ABABE4D87"><enum>(ii)</enum><text>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.</text>
</clause><clause id="HAC0B5540F9394856AFFFED7E0684AC41"><enum>(iii)</enum><text>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.</text>
</clause><clause id="H11FE5260FB094A58815EC301B3252C1F"><enum>(iv)</enum><text>The
plan or coverage document.</text>
</clause></subparagraph><subparagraph id="H76473FD930034CD1B95B93319F48BC8D"><enum>(E)</enum><header>Independent
determination</header><text>In making determinations under this section, a
qualified external review entity and an independent medical reviewer
shall—</text>
<clause id="H1691993543FA48AA863304A61F7FB79"><enum>(i)</enum><text>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</text>
</clause><clause id="H692C5F61F6A84421BF2FA2313DE8F31"><enum>(ii)</enum><text>consider, but not
be bound by, the definition used by the plan or issuer of <quote>medically
necessary and appropriate</quote>, or <quote>experimental or
investigational</quote>, 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.</text>
</clause></subparagraph><subparagraph id="H2FA3D2A68A0E4926A8E9731F42808086"><enum>(F)</enum><header>Determination of
independent medical reviewer</header><text>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—</text>
<clause id="H5A9FF89891D645E5B642A12AACC1EE5"><enum>(i)</enum><text>the
determination of the reviewer;</text>
</clause><clause id="HDA3E0D32BEAD47F69E464E8CF7EDE4B2"><enum>(ii)</enum><text>the
specific reasons of the reviewer for such determination, including a summary of
the clinical or scientific evidence used in making the determination;
and</text>
</clause><clause id="H093EE924D2E24026AF7E167F16396B32"><enum>(iii)</enum><text>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.</text>
</clause></subparagraph><subparagraph id="HC7B13DC6B4EA40A883E900496C34ECC8"><enum>(G)</enum><header>Nonbinding
nature of additional recommendations</header><text>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.</text>
</subparagraph></paragraph></subsection><subsection id="H677079287FD14793BCD81D86A99CFB1C"><enum>(e)</enum><header>Timelines and
notifications</header>
<paragraph id="HC4F9A60AE5D24494A8227B005F9FC3CE"><enum>(1)</enum><header>Timelines for
independent medical review</header>
<subparagraph id="HE989AE58449A46C9946BB1B232EFF64D"><enum>(A)</enum><header>Prior
authorization determination</header>
<clause id="H2BF52A80B0594F19B5F13E4411D3B400"><enum>(i)</enum><header>In
general</header><text>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.</text>
</clause><clause id="H26D782154D464B58A6C725082EE56C2E"><enum>(ii)</enum><header>Expedited
determination</header><text>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 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.</text>
</clause><clause id="H9A1E4EEE7D974C9486BE89C02FD9C9C0"><enum>(iii)</enum><header>Ongoing care
determination</header><text>Notwithstanding clause (i), in the case of a review
described in such clause 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.</text>
</clause></subparagraph><subparagraph id="H09AA86887F1E45A2AF253671A9B6E16"><enum>(B)</enum><header>Retrospective
determination</header><text>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.</text>
</subparagraph></paragraph><paragraph id="H4E19E234D67040E4BA56E559CA32DE51"><enum>(2)</enum><header>Notification of
determination</header><text>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.</text>
</paragraph><paragraph id="H521B5961FC0B43348C1208721BA88792"><enum>(3)</enum><header>Form of
notices</header><text>Determinations and notices under this subsection shall be
written in a manner calculated to be understood by a participant.</text>
</paragraph></subsection><subsection id="H9807F56259A34C5B96BCADAFAA1289C1"><enum>(f)</enum><header>Compliance</header>
<paragraph id="H6D891B5284C24719A29DA2A188CE17AD"><enum>(1)</enum><header>Application of
determinations</header>
<subparagraph id="H7A7C2401A64C4FABB06800B808F0FD08"><enum>(A)</enum><header>External review
determinations binding on plan</header><text>The determinations of an external
review entity and an independent medical reviewer under this section shall be
binding upon the plan or issuer involved.</text>
</subparagraph><subparagraph id="H3A28BD42E66340738B592D53F0730003"><enum>(B)</enum><header>Compliance with
determination</header><text>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.</text>
</subparagraph></paragraph><paragraph id="H27EC6FB0DF3F497C998FF0A4BBC7F54F"><enum>(2)</enum><header>Failure to
comply</header>
<subparagraph id="H5D51C3F9E1C144C9A98843A5345978A2"><enum>(A)</enum><header>In
general</header><text>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.</text>
</subparagraph><subparagraph id="H9C37D057002844ABA01FE5E44FF0CAC9"><enum>(B)</enum><header>Reimbursement</header>
<clause id="H10B5C6EDCCB14051A1B4F2356E9BD0B5"><enum>(i)</enum><header>In
general</header><text>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).</text>
</clause><clause id="H79A85C850D214A36B384D900AEAB1BA2"><enum>(ii)</enum><header>Amount</header><text>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.</text>
</clause></subparagraph><subparagraph id="HE96B9F3C071C4C72BD15A9886BC3027"><enum>(C)</enum><header>Failure to
reimburse</header><text>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.</text>
</subparagraph><subparagraph id="H3549D7CDC78E4BE8B318C6DBCF9D15"><enum>(D)</enum><header>Available
remedies</header><text>The remedies provided under this paragraph are in
addition to any other available remedies.</text>
</subparagraph></paragraph><paragraph id="HD984C78A048B45DEAB1B30D5179E1E5D"><enum>(3)</enum><header>Penalties
against authorized officials for refusing to authorize the determination of an
external review entity</header>
<subparagraph id="H3C66648F181F4BE6BA70966BBABF9C57"><enum>(A)</enum><header>Monetary
penalties</header>
<clause id="H2C6E1698F4A64A87B019C102B3854781"><enum>(i)</enum><header>In
general</header><text>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
of 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.</text>
</clause><clause id="HE5A42F7908964B74ADFB973FA57D111C"><enum>(ii)</enum><header>Additional
penalty for failing to follow timeline</header><text>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.</text>
</clause></subparagraph><subparagraph id="H299D60C850AC46A483D4465E2EB5A41C"><enum>(B)</enum><header>Cease and desist
order and order of attorney’s fees</header><text>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—</text>
<clause id="HF83444AE862647FD97CA513E03E0DCF2"><enum>(i)</enum><text>to
cease and desist from the alleged action or failure to act; and</text>
</clause><clause id="HDF6CB4DC81B0490BA46B41B1D85BDE27"><enum>(ii)</enum><text>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.</text>
</clause></subparagraph><subparagraph id="HE35D9CA1B1904FCB917201AFA9D2798F"><enum>(C)</enum><header>Additional civil
penalties</header>
<clause id="HE34771D974DA40A4A9DC37612738FF"><enum>(i)</enum><header>In
general</header><text>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—</text>
<subclause id="H4885A8C7ACEC453B00CDB8026344AEE0"><enum>(I)</enum><text>any pattern or
practice of repeated refusal to authorize a benefit determined by an external
appeal entity to be covered; or</text>
</subclause><subclause id="H5D53D37F3B764F21A56B000040B78027"><enum>(II)</enum><text>any pattern or
practice of repeated violations of the requirements of this section with
respect to such plan or coverage.</text>
</subclause></clause><clause id="H1D2CC8C0070B4537B455DC4020622512"><enum>(ii)</enum><header>Standard of
proof and amount of penalty</header><text>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—</text>
<subclause id="H3E23EDB21C8B47AB82BA92F08B003615"><enum>(I)</enum><text>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</text>
</subclause><subclause id="HBA143BA415DA4FC6A43DE7FF6C776D7"><enum>(II)</enum><text>$500,000.</text>
</subclause></clause></subparagraph><subparagraph id="HE475021988164DBD988C6001B226CE13"><enum>(D)</enum><header>Removal and
disqualification</header><text>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.</text>
</subparagraph></paragraph><paragraph id="HA69BADFE433148EF958079B2DFC044B"><enum>(4)</enum><header>Protection of
legal rights</header><text>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
<act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name>), including the right to file judicial actions to enforce
rights.</text>
</paragraph></subsection><subsection id="HCD4BC216B5C6462C87C5341D0000C48D"><enum>(g)</enum><header>Qualifications
of independent medical reviewers</header>
<paragraph id="HB785F70E84F84470AF5CCF4CFF07EEC6"><enum>(1)</enum><header>In
general</header><text>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—</text>
<subparagraph id="H418A511680614139AE131F2E54A12071"><enum>(A)</enum><text>each independent
medical reviewer meets the qualifications described in paragraphs (2) and
(3);</text>
</subparagraph><subparagraph id="H2C046CBABD2147A19C53006EEC002D44"><enum>(B)</enum><text>with respect to
each review at least 1 such reviewer meets the requirements described in
paragraphs (4) and (5); and</text>
</subparagraph><subparagraph id="H7CAE1C80E4604FE6B248BEAF48B883D7"><enum>(C)</enum><text>compensation
provided by the entity to the reviewer is consistent with paragraph (6).</text>
</subparagraph></paragraph><paragraph id="HD57C0B386B8F4F2B87D0F37C69207553"><enum>(2)</enum><header>Licensure and
expertise</header><text>Each independent medical reviewer shall be a physician
(allopathic or osteopathic) or health care professional who—</text>
<subparagraph id="HD8DA3E55F8FE46B3AA4E52929B908100"><enum>(A)</enum><text>is appropriately
credentialed or licensed in 1 or more States to deliver health care services;
and</text>
</subparagraph><subparagraph id="H1672D820BED542E8804B666C747E8294"><enum>(B)</enum><text>typically treats
the condition, makes the diagnosis, or provides the type of treatment under
review.</text>
</subparagraph></paragraph><paragraph id="H2C1C334E0FFE44C4B15200E932D2892"><enum>(3)</enum><header>Independence</header>
<subparagraph id="H57D4060217EC4874B9AF2546E1A595B"><enum>(A)</enum><header>In
general</header><text>Subject to subparagraph (B), each independent medical
reviewer in a case shall—</text>
<clause id="H7CF715AD16794F7DA483002FFF53E7AD"><enum>(i)</enum><text>not
be a related party (as defined in paragraph (7));</text>
</clause><clause id="HB98E3903DF8B4D47BE2055A19600B505"><enum>(ii)</enum><text>not
have a material familial, financial, or professional relationship with such a
party; and</text>
</clause><clause id="H9917C165417A41A99BD62E4459E91D4B"><enum>(iii)</enum><text>not otherwise
have a conflict of interest with such a party (as determined under
regulations).</text>
</clause></subparagraph><subparagraph id="HAF0E1D97125F496F8EC990A9AC18E3C1"><enum>(B)</enum><header>Exception</header><text>Nothing
in subparagraph (A) shall be construed to—</text>
<clause id="H869252653DBC4CCC935116B95C6B00BC"><enum>(i)</enum><text>prohibit an
individual, solely on the basis of affiliation with the plan or issuer, from
serving as an independent medical reviewer if—</text>
<subclause id="H64C672B580534AFEB3FFC2D3E42880A3"><enum>(I)</enum><text>a
non-affiliated individual is not reasonably available;</text>
</subclause><subclause id="H3D7BA91A5E5E437D873727A5F35BC128"><enum>(II)</enum><text>the affiliated
individual is not involved in the provision of items or services in the case
under review;</text>
</subclause><subclause id="H4BE6713ACD754905910000AFF115BFFB"><enum>(III)</enum><text>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</text>
</subclause><subclause id="HB6E5D257E4D3402995B5566E614009B8"><enum>(IV)</enum><text>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;</text>
</subclause></clause><clause id="HC0F16AD5DCFD408BBEE85D6B55364674"><enum>(ii)</enum><text>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</text>
</clause><clause id="HCB3C508CEFC845ACA105F83965449E"><enum>(iii)</enum><text>prohibit receipt
of compensation by an independent medical reviewer from an entity if the
compensation is provided consistent with paragraph (6).</text>
</clause></subparagraph></paragraph><paragraph id="H3FF79DDE59DC408E84C76279F33900DF"><enum>(4)</enum><header>Practicing
health care professional in same field</header>
<subparagraph id="H25AA56AFF352416F8BBCF2EC758EAD5F"><enum>(A)</enum><header>In
general</header><text>In a case involving treatment, or the provision of items
or services—</text>
<clause id="H65B69EC8EA3D4EA8B950B36D444D2B6F"><enum>(i)</enum><text>by a
physician, a reviewer shall be a practicing physician (allopathic or
osteopathic) of the same or similar specialty, as a physician who, acting
within the appropriate scope of practice within the State in which the service
is provided or rendered, typically treats the condition, makes the diagnosis,
or provides the type of treatment under review; or</text>
</clause><clause id="H78DACA291221438397B4E30B0953079"><enum>(ii)</enum><text>by a
non-physician health care professional, a reviewer (or reviewers) shall include
at least one practicing non-physician health care professional of the same or
similar specialty as the non-physician health care professional who, acting
within the appropriate scope of practice within the State in which the service
is provided or rendered, typically treats the condition, makes the diagnosis,
or provides the type of treatment under review.</text>
</clause></subparagraph><subparagraph id="H3BBA03565674413F9FF9EA41EEF6A51E"><enum>(B)</enum><header>Practicing
defined</header><text>For purposes of this paragraph, the term
<term>practicing</term> 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.</text>
</subparagraph></paragraph><paragraph id="HD0893573AFCF43DAAAE98006B61DEB81"><enum>(5)</enum><header>Pediatric
expertise</header><text>In the case of an external review relating to a child,
a reviewer shall have expertise under paragraph (2) in pediatrics.</text>
</paragraph><paragraph id="H698FBC46CD66438AA3F20001BE7C0024"><enum>(6)</enum><header>Limitations on
reviewer compensation</header><text>Compensation provided by a qualified
external review entity to an independent medical reviewer in connection with a
review under this section shall—</text>
<subparagraph id="H7A497C91275C49229F3BE4EAB476C126"><enum>(A)</enum><text>not exceed a
reasonable level; and</text>
</subparagraph><subparagraph id="H5843E6DFCEF84A2CA159E72976CD934F"><enum>(B)</enum><text>not be contingent
on the decision rendered by the reviewer.</text>
</subparagraph></paragraph><paragraph id="H3BF696202BF2457389034FAA97EAAF42"><enum>(7)</enum><header>Related party
defined</header><text>For purposes of this section, the term <term>related
party</term> 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:</text>
<subparagraph id="H5B1B6811F1F64293AE2FB78BE7DD4C32"><enum>(A)</enum><text>The plan, plan
sponsor, or issuer involved, or any fiduciary, officer, director, or employee
of such plan, plan sponsor, or issuer.</text>
</subparagraph><subparagraph id="H492E7E372AD34FA9BAE1001520A18D23"><enum>(B)</enum><text>The participant,
beneficiary, or enrollee (or authorized representative).</text>
</subparagraph><subparagraph id="H7E919D69AC07486993CB005C029BF246"><enum>(C)</enum><text>The health care
professional that provides the items or services involved in the denial.</text>
</subparagraph><subparagraph id="H0433BB7CB2DC4D80BA3E24A0EBFF44EE"><enum>(D)</enum><text>The institution at
which the items or services (or treatment) involved in the denial are
provided.</text>
</subparagraph><subparagraph id="H593EC25C202040E5BD7F513E2FD18292"><enum>(E)</enum><text>The manufacturer
of any drug or other item that is included in the items or services involved in
the denial.</text>
</subparagraph><subparagraph id="H124E6A0D034B4F0CBFAB9F4F5DF9A01D"><enum>(F)</enum><text>Any other party
determined under any regulations to have a substantial interest in the denial
involved.</text>
</subparagraph></paragraph></subsection><subsection id="H091A86CBA3A643C0B072F1061EF121A0"><enum>(h)</enum><header>Qualified
external review entities</header>
<paragraph id="HAAF093FAE81147FB8C27B539076BEBCB"><enum>(1)</enum><header>Selection of
qualified external review entities</header>
<subparagraph id="HC892B27C5E6A402486FA0795727BA071"><enum>(A)</enum><header>Limitation on
plan or issuer selection</header><text>The appropriate Secretary shall
implement procedures—</text>
<clause id="H02DCD7346A1B430C00B819F6461F54C"><enum>(i)</enum><text>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</text>
</clause><clause id="H8A0FD23884794B0CA2D82193C421CB3"><enum>(ii)</enum><text>for
auditing a sample of decisions by such entities to assure that no such
decisions are made in a biased manner.</text>
</clause><continuation-text continuation-text-level="subparagraph">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.</continuation-text></subparagraph><subparagraph id="H86FB7CD57E7C4A66885D1BC461CDC44"><enum>(B)</enum><header>State authority
with respect to qualified external review entities for health insurance
issuers</header><text>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.</text>
</subparagraph></paragraph><paragraph id="H8FA6C1D7321B480794C43300DD46B5E"><enum>(2)</enum><header>Contract with
qualified external review entity</header><text>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)).</text>
</paragraph><paragraph id="H74DE1ADB7731409C90D5E6BE27153E4D"><enum>(3)</enum><header>Terms and
conditions of contract</header><text>The terms and conditions of a contract
under paragraph (2) shall—</text>
<subparagraph id="H4E653EC6DCEE47D3B25707DD8D05C662"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="HB4E7D0830E864ED48880B9F944AC009E"><enum>(B)</enum><text>provide that the
costs of the external review process shall be borne by the plan or
issuer.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">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.</continuation-text></paragraph><paragraph id="HE6FBBC4FE7B04EC98993FDAEE59F937"><enum>(4)</enum><header>Qualifications</header>
<subparagraph id="H24D9E448253044EEB5CAF59606491657"><enum>(A)</enum><header>In
general</header><text>In this section, the term <term>qualified external review
entity</term> 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:</text>
<clause id="HBBE34CB80B1F41B4B9D88FAF00E2954"><enum>(i)</enum><text>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).</text>
</clause><clause id="H7DAA7E5C3A024A168F4D34FE106CE22B"><enum>(ii)</enum><text>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.</text>
</clause><clause id="H0F4A8152134B4008BEECC5DDE04CBC54"><enum>(iii)</enum><text>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.</text>
</clause><clause id="HDACCF82B25044A6FB8B4A83591B5000"><enum>(iv)</enum><text>The
entity has provided assurances that it will provide information in a timely
manner under subparagraph (D).</text>
</clause><clause id="HC029085733E9409C81A94069A7CE9E1D"><enum>(v)</enum><text>The
entity meets such other requirements as the appropriate Secretary provides by
regulation.</text>
</clause></subparagraph><subparagraph id="H92B89E6D6DF24DFB87CA9B2BF34655D6"><enum>(B)</enum><header>Independence
requirements</header>
<clause id="H0E59AD6BC5794882B8ACB973D8AB2631"><enum>(i)</enum><header>In
general</header><text>Subject to clause (ii), an entity meets the independence
requirements of this subparagraph with respect to any case if the
entity—</text>
<subclause id="H01CBD52463D54240B239A783D7004D01"><enum>(I)</enum><text>is not a related
party (as defined in subsection (g)(7));</text>
</subclause><subclause id="HA5A004DFD74A4DDBB2D9ACCE5BE0A7E9"><enum>(II)</enum><text>does not have a
material familial, financial, or professional relationship with such a party;
and</text>
</subclause><subclause id="H9CCEDCE6E9B04A7985E5DE73F5E800F4"><enum>(III)</enum><text>does not
otherwise have a conflict of interest with such a party (as determined under
regulations).</text>
</subclause></clause><clause id="H4E74D21CDA6741E9AA00D7972B74783B"><enum>(ii)</enum><header>Exception for
reasonable compensation</header><text>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).</text>
</clause><clause id="H6A321FC12E214DC9A0544300BA01F436"><enum>(iii)</enum><header>Limitations on
entity compensation</header><text>Compensation provided by a plan or issuer to
a qualified external review entity in connection with reviews under this
section shall—</text>
<subclause id="H166EF2767C1041219129FB46002E1C8C"><enum>(I)</enum><text>not exceed a
reasonable level; and</text>
</subclause><subclause id="HF587044494414170A4E4967EEBC2ADAB"><enum>(II)</enum><text>not be contingent
on any decision rendered by the entity or by any independent medical
reviewer.</text>
</subclause></clause></subparagraph><subparagraph id="H4B9EF0F83BAF49BC9000408B833635CA"><enum>(C)</enum><header>Certification
and recertification process</header>
<clause id="H5E4339D2B568488E8F4F038DE8BD1770"><enum>(i)</enum><header>In
general</header><text>The initial certification and recertification of a
qualified external review entity shall be made—</text>
<subclause id="HD8E47356FB8E40FCAEC28440AAA77735"><enum>(I)</enum><text>under a process
that is recognized or approved by the appropriate Secretary; or</text>
</subclause><subclause id="HEC8DD26952C8410FA24523259DE3F3DD"><enum>(II)</enum><text>by a qualified
private standard-setting organization that is approved by the appropriate
Secretary under clause (iii).</text>
</subclause><continuation-text continuation-text-level="clause">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.</continuation-text></clause><clause id="HCDE7DFB16899412A96BEBFCB971BCFFF"><enum>(ii)</enum><header>Process</header><text>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—</text>
<subclause id="H1969C769B97C439900001F4D85C09200"><enum>(I)</enum><text>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;</text>
</subclause><subclause id="HA1A4FF2C3EC94E9ABB796C902BCE5CA8"><enum>(II)</enum><text>will meet (and
has met, in the case of recertification) appropriate indicators of fiscal
integrity;</text>
</subclause><subclause id="H2BE89C6CBFCC47F7BEFBCB285FCA7A1"><enum>(III)</enum><text>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</text>
</subclause><subclause id="H89F152279DD446F99502A81CF351C75C"><enum>(IV)</enum><text>in the case of
recertification, shall review the matters described in clause (iv).</text>
</subclause></clause><clause id="HDE7B807F2C7C402FAE8F0001936D7BE7"><enum>(iii)</enum><header>Approval of
qualified private standard-setting organizations</header><text>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).</text>
</clause><clause id="H603106E90A074847AA5E63B883EB313"><enum>(iv)</enum><header>Considerations
in recertifications</header><text>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:</text>
<subclause id="H15E64757D6B74AD89F659017529CA995"><enum>(I)</enum><text>Provision of
information under subparagraph (D).</text>
</subclause><subclause id="H1D227894622C45ABB057E69F00003112"><enum>(II)</enum><text>Adherence to
applicable deadlines (both by the entity and by independent medical reviewers
it refers cases to).</text>
</subclause><subclause id="HA3C854BEE082493C897BFD243577703E"><enum>(III)</enum><text>Compliance with
limitations on compensation (with respect to both the entity and independent
medical reviewers it refers cases to).</text>
</subclause><subclause id="HEA8A65DABD1C430794419D57C6964F48"><enum>(IV)</enum><text>Compliance with
applicable independence requirements.</text>
</subclause><subclause id="HF9366A3208944026B0478081FB703B"><enum>(V)</enum><text>Compliance with the
requirement of subsection (d)(1) that only medically reviewable decisions shall
be the subject of independent medical review and with the requirement of
subsection (d)(3) that independent medical reviewers may not require coverage
for specifically excluded benefits.</text>
</subclause></clause><clause id="H3C0FF485280040CE92F2AAE4069DF4D4"><enum>(v)</enum><header>Period of
certification or recertification</header><text>A certification or
recertification provided under this paragraph shall extend for a period not to
exceed 2 years.</text>
</clause><clause id="H0DD807FE5BA34B7DB8DD42FCB5D8B81F"><enum>(vi)</enum><header>Revocation</header><text>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. The Secretary, or organization, shall revoke a
certification or deny a recertification with respect to an entity if there is a
showing that the entity has a pattern or practice of ordering coverage for
benefits that are specifically excluded under the plan or coverage.</text>
</clause><clause id="HCE8978BC6BE04BF19EE2752546E4008D"><enum>(vii)</enum><header>Petition for
denial or withdrawal</header><text>An individual may petition the Secretary, or
an organization providing the certification involves, for a denial of
recertification or a withdrawal of a certification with respect to an entity
under this subparagraph if there is a pattern or practice of such entity
failing to meet a requirement of this section.</text>
</clause><clause id="H59A5131A075342DF9C820999B400921C"><enum>(viii)</enum><header>Sufficient
number of entities</header><text>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.</text>
</clause></subparagraph><subparagraph id="H960DCA3D10DD4206AF9311D104A5C72"><enum>(D)</enum><header>Provision of
information</header>
<clause id="H024480AE44954096A03627DD004FCF7D"><enum>(i)</enum><header>In
general</header><text>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.</text>
</clause><clause id="HB8C83588C2784AB3B62E3CF651594F96"><enum>(ii)</enum><header>Information to
be included</header><text>The information described in this subclause with
respect to an entity is as follows:</text>
<subclause id="H6C6EAAEDEFEF462F87B7A1DF326F915B"><enum>(I)</enum><text>The number and
types of denials for which a request for review has been received by the
entity.</text>
</subclause><subclause id="H0A739A9D18A14156BDC1639984E89D7C"><enum>(II)</enum><text>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.</text>
</subclause><subclause id="H61F5CA021DF047878FD7D1F7DAC4F13"><enum>(III)</enum><text>The length of
time in making determinations with respect to such denials.</text>
</subclause><subclause id="HF2FB071592F64D34B5BE5FDEEADC24FC"><enum>(IV)</enum><text>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.</text>
</subclause></clause><clause id="H7E93656892D54F9CA7205768A86920E1"><enum>(iii)</enum><header>Information to
be provided to certifying organization</header>
<subclause id="HD755390F25274B61A187A803FE37EA15"><enum>(I)</enum><header>In
general</header><text>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).</text>
</subclause><subclause id="H1D9405F4917F4B9EBE12C7BC930067AC"><enum>(II)</enum><header>Additional
information</header><text>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.</text>
</subclause></clause><clause id="HB36178C6DA844F419B9DA81CF8FD37A0"><enum>(iv)</enum><header>Use of
information</header><text>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.</text>
</clause></subparagraph><subparagraph id="HB1D7D680C79D44C19522D6FBCB23DE0"><enum>(E)</enum><header>Limitation on
liability</header><text>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.</text>
</subparagraph></paragraph><paragraph id="H49C9B7651EAE4396B01088ADD4EEF404"><enum>(5)</enum><header>Report</header><text>Not
later than 12 months after the general effective date referred to in section
601, the General Accounting Office shall prepare and submit to the appropriate
committees of Congress a report concerning—</text>
<subparagraph id="HF120A56363FD474AA03DB42EBAACEDE2"><enum>(A)</enum><text>the information
that is provided under paragraph (3)(D);</text>
</subparagraph><subparagraph id="H9E353875F1EC4A96B5F3728D1DA67453"><enum>(B)</enum><text>the number of
denials that have been upheld by independent medical reviewers and the number
of denials that have been reversed by such reviewers; and</text>
</subparagraph><subparagraph id="HE971E63B70DB4DFB00C0D5D238466E11"><enum>(C)</enum><text>the extent to
which independent medical reviewers are requiring coverage for benefits that
are specifically excluded under the plan or coverage.</text>
</subparagraph></paragraph></subsection></section><section id="HF94D2D34841C45E29F04B85309AAE500"><enum>105.</enum><header>Health Care
Consumer Assistance Fund</header>
<subsection id="H62885672B5374EF7B04973710012C82F"><enum>(a)</enum><header>Grants</header>
<paragraph id="HEE49CF0BCBDC4A35965BF1FA71F6D5AA"><enum>(1)</enum><header>In
general</header><text>The Secretary of Health and Human Services (referred to
in this section as the <quote>Secretary</quote>) shall establish a fund, to be
known as the <quote>Health Care Consumer Assistance Fund</quote>, to be used to
award grants to eligible States to carry out consumer assistance activities
(including programs established by States prior to the enactment of this Act)
designed to provide information, assistance, and referrals to consumers of
health insurance products.</text>
</paragraph><paragraph id="HEEBF446C5F384207AB14FC005C7478AA"><enum>(2)</enum><header>State
eligibility</header><text>To be eligible to receive a grant under this
subsection a State shall prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as the Secretary may
require, including a State plan that describes—</text>
<subparagraph id="HFFE52C6BFFF34D538DDB934856191D87"><enum>(A)</enum><text>the manner in
which the State will ensure that the health care consumer assistance office
(established under paragraph (4)) will educate and assist health care consumers
in accessing needed care;</text>
</subparagraph><subparagraph id="H5433E6F7AEEB402B986697ABB47F139"><enum>(B)</enum><text>the manner in which
the State will coordinate and distinguish the services provided by the health
care consumer assistance office with the services provided by Federal, State
and local health-related ombudsman, information, protection and advocacy,
insurance, and fraud and abuse programs;</text>
</subparagraph><subparagraph id="HC760735528EE4C60854535DC42B46E9D"><enum>(C)</enum><text>the manner in
which the State will provide information, outreach, and services to
underserved, minority populations with limited English proficiency and
populations residing in rural areas;</text>
</subparagraph><subparagraph id="H1F93A1FB40454BF58D41B177782A079"><enum>(D)</enum><text>the manner in which
the State will oversee the health care consumer assistance office, its
activities, product materials and evaluate program effectiveness;</text>
</subparagraph><subparagraph id="H4AA2032FA5CE4554BCA351637F38C900"><enum>(E)</enum><text>the manner in
which the State will ensure that funds made available under this section will
be used to supplement, and not supplant, any other Federal, State, or local
funds expended to provide services for programs described under this section
and those described in subparagraphs (C) and (D);</text>
</subparagraph><subparagraph id="H72D9FDCDD9D444D79937A06C5DE4732D"><enum>(F)</enum><text>the manner in
which the State will ensure that health care consumer office personnel have the
professional background and training to carry out the activities of the office;
and</text>
</subparagraph><subparagraph id="HAF8E00DA1776467CA6D15217DEFFE5D4"><enum>(G)</enum><text>the manner in
which the State will ensure that consumers have direct access to consumer
assistance personnel during regular business hours.</text>
</subparagraph></paragraph><paragraph id="HC392EA4A71AB4081A700D45E43AF9848"><enum>(3)</enum><header>Amount of
grant</header>
<subparagraph id="H75A0E200F31941C7B5C484F184A6F9F"><enum>(A)</enum><header>In
general</header><text>From amounts appropriated under subsection (b) for a
fiscal year, the Secretary shall award a grant to a State in an amount that
bears the same ratio to such amounts as the number of individuals within the
State covered under a group health plan or under health insurance coverage
offered by a health insurance issuer bears to the total number of individuals
so covered in all States (as determined by the Secretary). Any amounts provided
to a State under this subsection that are not used by the State shall be
remitted to the Secretary and reallocated in accordance with this
subparagraph.</text>
</subparagraph><subparagraph id="H4BAAB082564D447D809901591C407E4B"><enum>(B)</enum><header>Minimum
amount</header><text>In no case shall the amount provided to a State under a
grant under this subsection for a fiscal year be less than an amount equal to
0.5 percent of the amount appropriated for such fiscal year to carry out this
section.</text>
</subparagraph><subparagraph id="HEC1B6295EB974A7D90BFD748B1BB56F4"><enum>(C)</enum><header>Non-federal
contributions</header><text>A State will provide for the collection of
non-Federal contributions for the operation of the office in an amount that is
not less than 25 percent of the amount of Federal funds provided to the State
under this section.</text>
</subparagraph></paragraph><paragraph id="H54A5124D7FFF4229B40037851450F49E"><enum>(4)</enum><header>Provision of
funds for establishment of office</header>
<subparagraph id="H1B6026CB63704A31B2D10681CC51F44"><enum>(A)</enum><header>In
general</header><text>From amounts provided under a grant under this
subsection, a State shall, directly or through a contract with an independent,
nonprofit entity with demonstrated experience in serving the needs of health
care consumers, provide for the establishment and operation of a State health
care consumer assistance office.</text>
</subparagraph><subparagraph id="HD26DDFDCCA1F4ECC948F9941F478BCA6"><enum>(B)</enum><header>Eligibility of
entity</header><text>To be eligible to enter into a contract under subparagraph
(A), an entity shall demonstrate that it has the technical, organizational, and
professional capacity to deliver the services described in subsection (b) to
all public and private health insurance participants, beneficiaries, enrollees,
or prospective enrollees.</text>
</subparagraph><subparagraph id="HC34F90B150EF4CF2AA4FF986A5FDAC8D"><enum>(C)</enum><header>Existing State
entity</header><text>Nothing in this section shall prevent the funding of an
existing health care consumer assistance program that otherwise meets the
requirements of this section.</text>
</subparagraph></paragraph></subsection><subsection id="HF19F3AC4571143E48733CBAC5E46E3D3"><enum>(b)</enum><header>Use of
funds</header>
<paragraph id="HFA67DB39B2E446B5B4CEE7F4C330CB1"><enum>(1)</enum><header>By
State</header><text>A State shall use amounts provided under a grant awarded
under this section to carry out consumer assistance activities directly or by
contract with an independent, non-profit organization. An eligible entity may
use some reasonable amount of such grant to ensure the adequate training of
personnel carrying out such activities. To receive amounts under this
subsection, an eligible entity shall provide consumer assistance services,
including—</text>
<subparagraph id="H03D2D3A1A1A64897A9C3A0B399052E04"><enum>(A)</enum><text>the operation of a
toll-free telephone hotline to respond to consumer requests;</text>
</subparagraph><subparagraph id="H23647D1951A24936A543A1C18787441B"><enum>(B)</enum><text>the dissemination
of appropriate educational materials on available health insurance products and
on how best to access health care and the rights and responsibilities of health
care consumers;</text>
</subparagraph><subparagraph id="H521DF26AC3ED461DA61DD91E1160E7C3"><enum>(C)</enum><text>the provision of
education on effective methods to promptly and efficiently resolve questions,
problems, and grievances;</text>
</subparagraph><subparagraph id="H03D4B511A5B744FCB8D608F42620470"><enum>(D)</enum><text>the coordination of
educational and outreach efforts with health plans, health care providers,
payers, and governmental agencies;</text>
</subparagraph><subparagraph id="HCB0B70B5B285454A81770062F2A667F8"><enum>(E)</enum><text>referrals to
appropriate private and public entities to resolve questions, problems and
grievances; and</text>
</subparagraph><subparagraph id="H86F099549CA04FC8A23B747184CC4556"><enum>(F)</enum><text>the provision of
information and assistance, including acting as an authorized representative,
regarding internal, external, or administrative grievances or appeals
procedures in nonlitigative settings to appeal the denial, termination, or
reduction of health care services, or the refusal to pay for such services,
under a group health plan or health insurance coverage offered by a health
insurance issuer.</text>
</subparagraph></paragraph><paragraph id="H6ECE2ACCB1FD4E9DBC9FE7361251EB2"><enum>(2)</enum><header>Confidentiality
and access to information</header>
<subparagraph id="H08B058DFD45849A2966FCABCCFF8FC00"><enum>(A)</enum><header>State
entity</header><text>With respect to a State that directly establishes a health
care consumer assistance office, such office shall establish and implement
procedures and protocols in accordance with applicable Federal and State
laws.</text>
</subparagraph><subparagraph id="H00BCEE40DB4844BA9C545B85003CACDA"><enum>(B)</enum><header>Contract
entity</header><text>With respect to a State that, through contract,
establishes a health care consumer assistance office, such office shall
establish and implement procedures and protocols, consistent with applicable
Federal and State laws, to ensure the confidentiality of all information shared
by a participant, beneficiary, enrollee, or their personal representative and
their health care providers, group health plans, or health insurance insurers
with the office and to ensure that no such information is used by the office,
or released or disclosed to State agencies or outside persons or entities
without the prior written authorization (in accordance with section 164.508 of
title 45, Code of Federal Regulations) of the individual or personal
representative. The office may, consistent with applicable Federal and State
confidentiality laws, collect, use or disclose aggregate information that is
not individually identifiable (as defined in section 164.501 of title 45, Code
of Federal Regulations). The office shall provide a written description of the
policies and procedures of the office with respect to the manner in which
health information may be used or disclosed to carry out consumer assistance
activities. The office shall provide health care providers, group health plans,
or health insurance issuers with a written authorization (in accordance with
section 164.508 of title 45, Code of Federal Regulations) to allow the office
to obtain medical information relevant to the matter before the office.</text>
</subparagraph></paragraph><paragraph id="HF3ACD620682644058895E5C6472124D8"><enum>(3)</enum><header>Availability of
services</header><text>The health care consumer assistance office of a State
shall not discriminate in the provision of information, referrals, and services
regardless of the source of the individual’s health insurance coverage or
prospective coverage, including individuals covered under a group health plan
or health insurance coverage offered by a health insurance issuer, the medicare
or medicaid programs under title XVIII or XIX of the
<act-name parsable-cite="SSA">Social Security Act</act-name> (42 U.S.C. 1395
and 1396 et seq.), or under any other Federal or State health care
program.</text>
</paragraph><paragraph id="HF3636DD7E49B42E1BE47D2E395ED8DF7"><enum>(4)</enum><header>Designation of
responsibilities</header>
<subparagraph id="HAC886085E22541E083E989608F61AC96"><enum>(A)</enum><header>Within existing
State entity</header><text>If the health care consumer assistance office of a
State is located within an existing State regulatory agency or office of an
elected State official, the State shall ensure that—</text>
<clause id="H30305EAAD309404DB4F19FB758737FC1"><enum>(i)</enum><text>there is a
separate delineation of the funding, activities, and responsibilities of the
office as compared to the other funding, activities, and responsibilities of
the agency; and</text>
</clause><clause id="HFE9452EC674A4AB283FE2772A69DEF29"><enum>(ii)</enum><text>the
office establishes and implements procedures and protocols to ensure the
confidentiality of all information shared by a participant, beneficiary, or
enrollee or their personal representative and their health care providers,
group health plans, or health insurance issuers with the office and to ensure
that no information is disclosed to the State agency or office without the
written authorization of the individual or their personal representative in
accordance with paragraph (2).</text>
</clause></subparagraph><subparagraph id="HEAA2C18ABC6A494D8C096006ECA646E"><enum>(B)</enum><header>Contract
entity</header><text>In the case of an entity that enters into a contract with
a State under subsection (a)(3), the entity shall provide assurances that the
entity has no conflict of interest in carrying out the activities of the office
and that the entity is independent of group health plans, health insurance
issuers, providers, payers, and regulators of health care.</text>
</subparagraph></paragraph><paragraph id="HD63699108D284249AD2E8C39671BBDE"><enum>(5)</enum><header>Subcontracts</header><text>The
health care consumer assistance office of a State may carry out activities and
provide services through contracts entered into with 1 or more nonprofit
entities so long as the office can demonstrate that all of the requirements of
this section are complied with by the office.</text>
</paragraph><paragraph id="H4027E2F6EE564E659C003DFEFB3940C8"><enum>(6)</enum><header>Term</header><text>A
contract entered into under this subsection shall be for a term of 3
years.</text>
</paragraph></subsection><subsection id="H03886CA19B2F464692D0B4FF68644A1"><enum>(c)</enum><header>Report</header><text>Not
later than 1 year after the Secretary first awards grants under this section,
and annually thereafter, the Secretary shall prepare and submit to the
appropriate committees of Congress a report concerning the activities funded
under this section and the effectiveness of such activities in resolving health
care-related problems and grievances.</text>
</subsection><subsection id="H9BAB144387FF45C181CF01B600789C9F"><enum>(d)</enum><header>Authorization of
appropriations</header><text>There are authorized to be appropriated such sums
as may be necessary to carry out this section.</text>
</subsection></section></subtitle><subtitle id="HC3D60C563041447798C534895479CDD9"><enum>B</enum><header>Access to
care</header>
<section id="H58965AD711F54A099C1B3CB772536401"><enum>111.</enum><header>Consumer choice
option</header>
<subsection id="HBD9F9C21F017416F9FA4A156853BDDB4"><enum>(a)</enum><header>In
general</header><text>If—</text>
<paragraph id="H149876F943B64D98B91B3506C9B7CA1"><enum>(1)</enum><text>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 (including physician pathology 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</text>
</paragraph><paragraph id="H22A2495279524CD6B0499D3F79EEB91D"><enum>(2)</enum><text>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,</text>
</paragraph><continuation-text continuation-text-level="subsection">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.</continuation-text></subsection><subsection id="H4123301563D4418BAC5BBE4D001BD810"><enum>(b)</enum><header>Additional
costs</header><text>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.</text>
</subsection><subsection id="H89CF048E01824480BA7789485D880086"><enum>(c)</enum><header>Open
season</header><text>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.</text>
</subsection></section><section id="H62A679B9D8484F63B4E4D7177BEE32D"><enum>112.</enum><header>Choice of health
care professional</header>
<subsection id="HA641463AA48F492A9E426FCA2393B998"><enum>(a)</enum><header>Primary
care</header><text>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.</text>
</subsection><subsection id="H6740C56BF4F1430784A4B19FDAF9255D"><enum>(b)</enum><header>Specialists</header>
<paragraph id="HF09BA2E1537945AC89B25BA176FE0009"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="HA12CDC1D1842459F9D2B44DA7FB574FE"><enum>(2)</enum><header>Limitation</header><text>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.</text>
</paragraph><paragraph id="H9C487A469F4849CCB22E5F56871FD8FA"><enum>(3)</enum><header>Construction</header><text>Nothing
in this subsection shall be construed as affecting the application of section
114 (relating to access to specialty care).</text>
</paragraph></subsection></section><section id="H8547821D0CFA4C25BAD277968C348708"><enum>113.</enum><header>Access to
emergency care</header>
<subsection id="H2B589B7BDDE341498E00598D317D09EA"><enum>(a)</enum><header>Coverage of
emergency services</header>
<paragraph id="H175F50D9B219438A9F22C5977757C29C"><enum>(1)</enum><header>In
general</header><text>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))—</text>
<subparagraph id="H1AB3566B95324C31BD167EB56B34E0C0"><enum>(A)</enum><text>without the need
for any prior authorization determination;</text>
</subparagraph><subparagraph id="HA12A5A89E3624DB0A89E03100855EAAE"><enum>(B)</enum><text>whether the health
care provider furnishing such services is a participating provider with respect
to such services;</text>
</subparagraph><subparagraph id="HA7180011CA6F4544B008CD7BBCE13C93"><enum>(C)</enum><text>in a manner so
that, if such services are provided to a participant, beneficiary, or
enrollee—</text>
<clause id="HF2AF9BBEFCD2440DA8726674FA19EF2C"><enum>(i)</enum><text>by a
nonparticipating health care provider with or without prior authorization,
or</text>
</clause><clause id="HAE6D24286F474769AC13159FCB66B1B"><enum>(ii)</enum><text>by a
participating health care provider without prior authorization,</text>
</clause><continuation-text continuation-text-level="subparagraph">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</continuation-text></subparagraph><subparagraph id="H2FFF318632D3478391AA08BED31225C"><enum>(D)</enum><text>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 <act-name parsable-cite="PHSA">Public Health Service
Act</act-name>, section 701 of the <act-name parsable-cite="ERISA">Employee
Retirement Income Security Act of 1974</act-name>, or section 9801 of the
Internal Revenue Code of 1986, and other than applicable cost-sharing).</text>
</subparagraph></paragraph><paragraph id="HB01F1011781F4F0CA861CAD7D3435373"><enum>(2)</enum><header>Definitions</header><text>In
this section:</text>
<subparagraph id="H7ED5F15039F8439181B07EF674C94856"><enum>(A)</enum><header>Emergency
medical condition</header><text>The term <term>emergency medical
condition</term> 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
<act-name parsable-cite="SSA">Social Security Act</act-name>.</text>
</subparagraph><subparagraph id="H7D32B2FDFCAA4F1AA699E800DF9132D3"><enum>(B)</enum><header>Emergency
services</header><text>The term <term>emergency services</term> means, with
respect to an emergency medical condition—</text>
<clause id="H57B09A4F20E744A6A9809942BC5BF1F6"><enum>(i)</enum><text>a
medical screening examination (as required under section 1867 of the
<act-name parsable-cite="SSA">Social Security Act</act-name>) 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</text>
</clause><clause id="H46013CB66EF44053A44D532959580320"><enum>(ii)</enum><text>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.</text>
</clause></subparagraph><subparagraph id="HBEA612564D03479B97C4D8719BDD26BE"><enum>(C)</enum><header>Stabilize</header><text>The
term <term>to stabilize</term>, with respect to an emergency medical condition
(as defined in subparagraph (A)), has the meaning given in section 1867(e)(3)
of the <act-name parsable-cite="SSA">Social Security Act</act-name> (42 U.S.C.
1395dd(e)(3)).</text>
</subparagraph></paragraph></subsection><subsection id="H66A6F2FBB9E04D839E22000939252815"><enum>(b)</enum><header>Reimbursement
for maintenance care and post-stabilization care</header><text>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
<act-name parsable-cite="SSA">Social Security Act</act-name> (42 U.S.C.
1395w–22(d)(2)). Such reimbursement shall be provided in a manner consistent
with subsection (a)(1)(C).</text>
</subsection><subsection id="HD7233EF4E10F4812874DE0CE51F325AB"><enum>(c)</enum><header>Coverage of
emergency ambulance services</header>
<paragraph id="HA14FDC7A447D463CBB01546E96C108F2"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="H26D875B3B25544B5B6D1F577FB3CBF55"><enum>(2)</enum><header>Emergency
ambulance services</header><text>For purposes of this subsection, the term
<term>emergency ambulance services</term> means ambulance services (as defined
for purposes of section 1861(s)(7) of the <act-name parsable-cite="SSA">Social
Security Act</act-name>) 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.</text>
</paragraph></subsection></section><section id="H5B6A3E0C861249EE8CCE36EE8B97D133"><enum>114.</enum><header>Timely access
to specialists</header>
<subsection id="H59CD4F89BB664E83B222EB5BBF80075"><enum>(a)</enum><header>Timely
access</header>
<paragraph id="H0D26B6DF112D4BE4B40130D4E42411D"><enum>(1)</enum><header>In
general</header><text>A group health plan and a 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.</text>
</paragraph><paragraph id="H04C4FCA8B7AB47B086956D009999B195"><enum>(2)</enum><header>Rule of
construction</header><text>Nothing in paragraph (1) shall be construed—</text>
<subparagraph id="H06FA08E1576344A8A9EADB381249F27"><enum>(A)</enum><text>to require the
coverage under a group health plan or health insurance coverage of benefits or
services;</text>
</subparagraph><subparagraph id="HE1C4048735FC46F28E661E38CCDFD7B2"><enum>(B)</enum><text>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</text>
</subparagraph><subparagraph id="H232135B698E64D65A4AE3413DED5C96"><enum>(C)</enum><text>to override any
State licensure or scope-of-practice law.</text>
</subparagraph></paragraph><paragraph id="HFCBCBD43D8264DB089C329CBFD2C886"><enum>(3)</enum><header>Access to certain
providers</header>
<subparagraph id="H85700C9CEF6B4D50801F89DF6BCE279C"><enum>(A)</enum><header>In
general</header><text>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.</text>
</subparagraph><subparagraph id="H74531A148E8944A1B8441300E4007841"><enum>(B)</enum><header>Treatment of
nonparticipating providers</header><text>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.</text>
</subparagraph></paragraph></subsection><subsection id="H86E55E4B0A6644E8B2A9ABB47772D443"><enum>(b)</enum><header>Referrals</header>
<paragraph id="H89D4994DC2DA4D8AB643FBEBF3E60011"><enum>(1)</enum><header>Authorization</header><text>Subject
to subsection (a)(1), 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—</text>
<subparagraph id="H1A4B2C116E774DC699004E7108992268"><enum>(A)</enum><text>shall be for an
appropriate duration of time or number of referrals, including an authorization
for a standing referral where appropriate; and</text>
</subparagraph><subparagraph id="HE2954219A27E46E50088AA90C5DAE8B2"><enum>(B)</enum><text>may not be refused
solely because the authorization involves services of a nonparticipating
specialist (described in subsection (a)(3)).</text>
</subparagraph></paragraph><paragraph id="H24617BC028E1461F9100F3B899FF09AC"><enum>(2)</enum><header>Referrals for
ongoing special conditions</header>
<subparagraph id="HD899B79326634997B9250019D625D9EB"><enum>(A)</enum><header>In
general</header><text>Subject to subsection (a)(1), a group health plan and a
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.</text>
</subparagraph><subparagraph id="H63E4561E5B6F4455A22EEB9590DE00F2"><enum>(B)</enum><header>Ongoing special
condition defined</header><text>In this subsection, the term <term>ongoing
special condition</term> means a condition or disease that—</text>
<clause id="H557B8C6DFC46454C8E889C6C88B88019"><enum>(i)</enum><text>is
life-threatening, degenerative, potentially disabling, or congenital;
and</text>
</clause><clause id="H44FC2B2FD0734DAE8772818CAA751E34"><enum>(ii)</enum><text>requires
specialized medical care over a prolonged period of time.</text>
</clause></subparagraph></paragraph></subsection><subsection id="H44B273189DD749E790687B6E63E5847C"><enum>(c)</enum><header>Treatment
plans</header>
<paragraph id="HA49E0D5A2C0E4DB6A7FED618D4F1515C"><enum>(1)</enum><header>In
general</header><text>A group health plan or health insurance issuer may
require that the specialty care be provided—</text>
<subparagraph id="HCFEEF6CBDB424CC99541C63E683044CA"><enum>(A)</enum><text>pursuant to a
treatment plan, but only if the treatment plan—</text>
<clause id="H500C4FB70C29497893D67E8808003F84"><enum>(i)</enum><text>is
developed by the specialist, in consultation with the case manager or primary
care provider, and the participant, beneficiary, or enrollee, and</text>
</clause><clause id="H3DDD1902A7964911A276CCBE05E115B8"><enum>(ii)</enum><text>is
approved by the plan or issuer in a timely manner, if the plan or issuer
requires such approval; and</text>
</clause></subparagraph><subparagraph id="H983B1AF4121A4C2CB065E8BF44551315"><enum>(B)</enum><text>in accordance with
applicable quality assurance and utilization review standards of the plan or
issuer.</text>
</subparagraph></paragraph><paragraph id="H04C2730CFD2D4E34B4A6BC274E91EC9C"><enum>(2)</enum><header>Notification</header><text>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.</text>
</paragraph></subsection><subsection id="HE5346D7100FC44DA00C888803F625123"><enum>(d)</enum><header>Specialist
defined</header><text>For purposes of this section, the term
<term>specialist</term> 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.</text>
</subsection></section><section id="H908AC49B410B45BCAC718C8500F488F5"><enum>115.</enum><header>Patient access
to obstetrical and gynecological care</header>
<subsection id="HCB143BB49F7E4476B3B64777F44728A7"><enum>(a)</enum><header>General
rights</header>
<paragraph id="HF8CCE1EA0A54426189C3E16274FE133B"><enum>(1)</enum><header>Direct
access</header><text>A group health plan, and a 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.</text>
</paragraph><paragraph id="HCDFBC3F642CB44DD9B3D3CC614338BD7"><enum>(2)</enum><header>Obstetrical and
gynecological care</header><text>A group health plan and a 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.</text>
</paragraph></subsection><subsection id="HAEE82AC137B04605AC29F569C8D09080"><enum>(b)</enum><header>Application of
Section</header><text>A group health plan, or health insurance issuer offering
health insurance coverage, described in this subsection is a group health plan
or coverage that—</text>
<paragraph id="H41A58D0BE97146779EE0A524D900DB17"><enum>(1)</enum><text>provides coverage
for obstetric or gynecologic care; and</text>
</paragraph><paragraph id="H040BD05C0ED64E85973D861478D54D96"><enum>(2)</enum><text>requires the
designation by a participant, beneficiary, or enrollee of a participating
primary care provider.</text>
</paragraph></subsection><subsection id="HAA879858F9074D03BBE636B8007FD5C0"><enum>(c)</enum><header>Construction</header><text>Nothing
in subsection (a) shall be construed to—</text>
<paragraph id="HE7009D92CDDE48E900B37CF280C2AD50"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="H8622FC79E4BD4853A97B18C2C6B3547F"><enum>(2)</enum><text>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.</text>
</paragraph></subsection></section><section id="H9C17AE12B53B4335BD80EF3B009DB4C0"><enum>116.</enum><header>Access to
pediatric care</header>
<subsection id="H830FACCF56CC4BCD9F6B71C10367C19E"><enum>(a)</enum><header>Pediatric
care</header><text>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.</text>
</subsection><subsection id="H2519E8FFC2484A63AA14C8D00FD0433"><enum>(b)</enum><header>Construction</header><text>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.</text>
</subsection></section><section id="HAF297D5C86C94704B744F92EB12DB418"><enum>117.</enum><header>Continuity of
care</header>
<subsection id="H9A97AAB23C1642AB87B9592E6B96737F"><enum>(a)</enum><header>Termination of
provider</header>
<paragraph id="H3207E03DA6B34F979CD251EBD950F13"><enum>(1)</enum><header>In
general</header><text>If—</text>
<subparagraph id="HB4EE1700AA3E48DA8452A4CC988B99EA"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="H68C7259B24614A45B2FFCDD8D1C9C205"><enum>(B)</enum><text>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,</text>
</subparagraph><continuation-text continuation-text-level="paragraph">the plan or
issuer shall meet the requirements of paragraph (3) with respect to each
continuing care patient.</continuation-text></paragraph><paragraph id="H8D5FA773131848F69051EE00F4067EC6"><enum>(2)</enum><header>Treatment of
termination of contract with health insurance issuer</header><text>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.</text>
</paragraph><paragraph id="H20AB5FD7A56941D5B300115E542FE150"><enum>(3)</enum><header>Requirements</header><text>The
requirements of this paragraph are that the plan or issuer—</text>
<subparagraph id="H0C86F9198AD84A44BCEA35E71E6B2D5E"><enum>(A)</enum><text>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;</text>
</subparagraph><subparagraph id="H6870F63DCA21463E9DD93C537439669F"><enum>(B)</enum><text>provide the
patient with an opportunity to notify the plan or issuer of the patient’s need
for transitional care; and</text>
</subparagraph><subparagraph id="H2D450D95D1FC4AFF9B807578DF5D2437"><enum>(C)</enum><text>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)).</text>
</subparagraph></paragraph><paragraph id="H7A16D1C01FE7458FA5D0F5DEB3E192E"><enum>(4)</enum><header>Continuing care
patient</header><text>For purposes of this section, the term <term>continuing
care patient</term> means a participant, beneficiary, or enrollee who—</text>
<subparagraph id="HF02764E743684222896B340000C7C753"><enum>(A)</enum><text>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);</text>
</subparagraph><subparagraph id="H02CCD9CED78046CBBB193430BFB8CFA6"><enum>(B)</enum><text>is undergoing a
course of institutional or inpatient care from the provider at the time of such
notice;</text>
</subparagraph><subparagraph id="HBEE245538DA349268E6FD4A23C446E19"><enum>(C)</enum><text>is scheduled to
undergo non-elective surgery from the provider at the time of such
notice;</text>
</subparagraph><subparagraph id="HEBB8441BBE41489092D1733632F1DF2E"><enum>(D)</enum><text>is pregnant and
undergoing a course of treatment for the pregnancy from the provider at the
time of such notice; or</text>
</subparagraph><subparagraph id="H57AFD9EE40EF4A36865F65D7E13A072"><enum>(E)</enum><text>is or was
determined to be terminally ill (as determined under section 1861(dd)(3)(A) of
the <act-name parsable-cite="SSA">Social Security Act</act-name>) 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.</text>
</subparagraph></paragraph></subsection><subsection id="HEBB61A013972482AA8E330AC1160D1"><enum>(b)</enum><header>Transitional
periods</header>
<paragraph id="HA4E436EEE1244C978F6EFC9D961985AA"><enum>(1)</enum><header>Serious and
complex conditions</header><text>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).</text>
</paragraph><paragraph id="H435EF2CAEA664B16BA87B208757325F"><enum>(2)</enum><header>Institutional or
inpatient care</header><text>The transitional period under this subsection for
a continuing care patient described in subsection (a)(4)(B) shall extend until
the earlier of—</text>
<subparagraph id="H928B05426BC44A1DA168EFB86397CB00"><enum>(A)</enum><text>the expiration of
the 90-day period beginning on the date on which the notice under subsection
(a)(3)(A) is provided; or</text>
</subparagraph><subparagraph id="HE81668E06BCC46249870FA53A9C06DB7"><enum>(B)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="HD22A92F4330B4488A4011004F897F1B7"><enum>(3)</enum><header>Scheduled
non-elective surgery</header><text>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.</text>
</paragraph><paragraph id="H9ECA559972C74E2686C13CE0D902E41C"><enum>(4)</enum><header>Pregnancy</header><text>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.</text>
</paragraph><paragraph id="HC94C97E87AA6486896D4CE4D3FD5F69F"><enum>(5)</enum><header>Terminal
illness</header><text>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.</text>
</paragraph></subsection><subsection id="HE8B33F295B1B40C6B7DA908B10CCD4CD"><enum>(c)</enum><header>Permissible
terms and conditions</header><text>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:</text>
<paragraph id="HB393342004E54438A894A2DB84F3798"><enum>(1)</enum><text>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.</text>
</paragraph><paragraph id="HCC156FACD1284BA49784A8EB005000A"><enum>(2)</enum><text>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.</text>
</paragraph><paragraph id="H0CEA54F062C0475B8C82490055001891"><enum>(3)</enum><text>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.</text>
</paragraph></subsection><subsection id="HFA00A7556468435FA8FA2BBA6F32C659"><enum>(d)</enum><header>Rules of
construction</header><text>Nothing in this section shall be construed—</text>
<paragraph id="H64D5CB4AC05F4080B0ACD2AB92E62CE2"><enum>(1)</enum><text>to require the
coverage of benefits which would not have been covered if the provider involved
remained a participating provider; or</text>
</paragraph><paragraph id="H3640F6867EAC4937AD581878FE71E8B7"><enum>(2)</enum><text>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—</text>
<subparagraph id="HD166E3DC630E44B1B0AAA503F930F0C9"><enum>(A)</enum><text>notify
participants, beneficiaries, or enrollees of their rights under this section;
or</text>
</subparagraph><subparagraph id="HBB41096F4DBA458482EAC7F05BA3FEE6"><enum>(B)</enum><text>provide the plan
or issuer with the name of each participant, beneficiary, or enrollee who the
provider believes is a continuing care patient.</text>
</subparagraph></paragraph></subsection><subsection id="H81A17EEE517D490BA6A3C88D20EE15E"><enum>(e)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="HA8D82CCE2A8749A8B3B25517EA44EE51"><enum>(1)</enum><header>Contract</header><text>The
term <term>contract</term> 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.</text>
</paragraph><paragraph id="H9D26770BD4904189A3CB33A52FB3C72E"><enum>(2)</enum><header>Health care
provider</header><text>The term <term>health care provider</term> or
<term>provider</term> means—</text>
<subparagraph id="HB5154A706E4A43988F6405A784B8E861"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="H49163EF95D7E4EFEAF67F281F587F3FB"><enum>(B)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="H2CAC033926034CFA8FCCABB3C08EDB27"><enum>(3)</enum><header>Serious and
complex condition</header><text>The term <term>serious and complex
condition</term> means, with respect to a participant, beneficiary, or enrollee
under the plan or coverage—</text>
<subparagraph id="H66D6AE8E30FC47DF89E55BE77A5889C"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="HEFAEAE44EF0342A48623F48B63DD29FF"><enum>(B)</enum><text>in the case of a
chronic illness or condition, is an ongoing special condition (as defined in
section 114(b)(2)(B)).</text>
</subparagraph></paragraph><paragraph id="HB9428ADF586B4529958555101F1BA700"><enum>(4)</enum><header>Terminated</header><text>The
term <term>terminated</term> 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.</text>
</paragraph></subsection></section><section id="H3E71E7EF7933482E8C6EBA2EDD36E5EE"><enum>118.</enum><header>Access to
needed prescription drugs</header>
<subsection id="H0063C1FC40DB4B10A1834F92A50266F"><enum>(a)</enum><header>In
general</header><text>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—</text>
<paragraph id="H45D3E805E99443C081E944C1EB269B00"><enum>(1)</enum><text>ensure the
participation of physicians and pharmacists in developing and reviewing such
formulary;</text>
</paragraph><paragraph id="HF0CF269F27914ACA9FC29601B8F8C7F0"><enum>(2)</enum><text>provide for
disclosure of the formulary to providers; and</text>
</paragraph><paragraph id="H7D9DD4CF04AC4F6C8436007BA483CE18"><enum>(3)</enum><text>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.</text>
</paragraph></subsection><subsection id="H5E945A1B3E3D474FB782E5F600EAB85C"><enum>(b)</enum><header>Coverage of
approved drugs and medical devices</header>
<paragraph id="H91C383E47A8C4F039EFD7D00563455E9"><enum>(1)</enum><header>In
general</header><text>A group health plan (and 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—</text>
<subparagraph id="HF22AFC46B5B14FB2992D39B296A63700"><enum>(A)</enum><text>in the case of a
prescription drug—</text>
<clause id="H79247514F8CE443EBF3E254254F188DB"><enum>(i)</enum><text>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
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>, without regard to any postmarketing requirements that may apply
under such Act; or</text>
</clause><clause id="H82E709F42A1744F5858EAE6F2E265D14"><enum>(ii)</enum><text>is
included in the labeling authorized by the application in effect for the drug
under section 351 of the <act-name parsable-cite="PHSA">Public Health Service
Act</act-name>, without regard to any postmarketing requirements that may apply
pursuant to such section; or</text>
</clause></subparagraph><subparagraph id="H3FA0D6D700EF4BB3AAE154BA549B42F0"><enum>(B)</enum><text>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 <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>, 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.</text>
</subparagraph></paragraph><paragraph id="H3C4B8F2154C348228BEFEFA0ADC18598"><enum>(2)</enum><header>Construction</header><text>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.</text>
</paragraph></subsection></section><section id="HA1664824F5A44166B8A75782D4D3EC94"><enum>119.</enum><header>Coverage for
individuals participating in approved clinical trials</header>
<subsection id="HA902416FD18843FA00456311A7B4DC8"><enum>(a)</enum><header>Coverage</header>
<paragraph id="H485FA3101F6746BFBBFFB8B49E30FCAB"><enum>(1)</enum><header>In
general</header><text>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—</text>
<subparagraph id="H555F6EEE7A3A43EDBF26D182463F2B33"><enum>(A)</enum><text>may not deny the
individual participation in the clinical trial referred to in subsection
(b)(2);</text>
</subparagraph><subparagraph id="H6019E67D4DDE470593BA61B1467B38C"><enum>(B)</enum><text>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</text>
</subparagraph><subparagraph id="HFBBC424E24F84E31AAD376937B803D5C"><enum>(C)</enum><text>may not
discriminate against the individual on the basis of the enrollee’s
participation in such trial.</text>
</subparagraph></paragraph><paragraph id="H4AF4B9926D964FB483D3D0DFFAB16400"><enum>(2)</enum><header>Exclusion of
certain costs</header><text>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.</text>
</paragraph><paragraph id="H677F094748FA45AF974677C92BB508CC"><enum>(3)</enum><header>Use of
in-network providers</header><text>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.</text>
</paragraph></subsection><subsection id="H19CE081B63374214991C6FFD6C940000"><enum>(b)</enum><header>Qualified
individual defined</header><text>For purposes of subsection (a), the term
<term>qualified individual</term> 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:</text>
<paragraph id="HD7E693935F9448818792B0EFC9007759"><enum>(1)</enum><text>(A) The individual
has a life-threatening or serious illness for which no standard treatment is
effective.</text>
<subparagraph id="H33DCEBB4FE6A45BEA8D15BF10DFE2A1" indent="up1"><enum>(B)</enum><text>The individual is eligible to
participate in an approved clinical trial according to the trial protocol with
respect to treatment of such illness.</text>
</subparagraph><subparagraph id="HC705CFE3D30D4252A3E0E0D284AF7CCE" indent="up1"><enum>(C)</enum><text>The individual’s participation in the
trial offers meaningful potential for significant clinical benefit for the
individual.</text>
</subparagraph></paragraph><paragraph id="HF0E7BC8D60CA43B7ABBEEF050439D310"><enum>(2)</enum><text>Either—</text>
<subparagraph id="H3735F2022E3746ADABE202C5396B8880"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="H6635C18E12E7453A8FE218C71380C9D0"><enum>(B)</enum><text>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).</text>
</subparagraph></paragraph></subsection><subsection id="H78DA277C331E434F008967FB1152F2BF"><enum>(c)</enum><header>Payment</header>
<paragraph id="HBE667DCCAC2A47919B7C3D62D1DC34B3"><enum>(1)</enum><header>In
general</header><text>Under this section a group health plan and a 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.</text>
</paragraph><paragraph id="HDECCCF1E2D90461493194BC46632DB4E"><enum>(2)</enum><header>Payment
rate</header><text>In the case of covered items and services provided
by—</text>
<subparagraph id="H27A41238C0FC494E98869F2F6309EFC7"><enum>(A)</enum><text>a participating
provider, the payment rate shall be at the agreed upon rate; or</text>
</subparagraph><subparagraph id="H800217383F59420E9F9800E230048494"><enum>(B)</enum><text>a nonparticipating
provider, the payment rate shall be at the rate the plan or issuer would
normally pay for comparable services under subparagraph (A).</text>
</subparagraph></paragraph></subsection><subsection id="HDD9225BC924C417887B4474F48DBC9F2"><enum>(d)</enum><header>Approved
clinical trial defined</header>
<paragraph id="H79D5003C2F7744CD95943BBDB145A49F"><enum>(1)</enum><header>In
general</header><text>In this section, the term <term>approved clinical
trial</term> means a clinical research study or clinical investigation—</text>
<subparagraph id="H27F47B4C44FC494BBD00129E00EAE3D"><enum>(A)</enum><text>approved and funded
(which may include funding through in-kind contributions) by one or more of the
following:</text>
<clause id="HDD48B7B964974746B551429364E705D3"><enum>(i)</enum><text>the
National Institutes of Health;</text>
</clause><clause id="HDED0B0D574F24E9EA929CA0017C7D1A"><enum>(ii)</enum><text>a
cooperative group or center of the National Institutes of Health, including a
qualified nongovernmental research entity to which the National Cancer
Institute has awarded a center support grant;</text>
</clause><clause id="HE47475A9427C4CFBA0FC5251D13463B4"><enum>(iii)</enum><text>either of the
following if the conditions described in paragraph (2) are met—</text>
<subclause id="HF1FB289B69F84FFFA22FDF007CE166F6"><enum>(I)</enum><text>the Department of
Veterans Affairs;</text>
</subclause><subclause id="HBE943247427C4A29B100BE8B8FF3EE9"><enum>(II)</enum><text>the Department of
Defense; or</text>
</subclause></clause></subparagraph><subparagraph id="HF3D7AE9936A6464380B600F9763E58BC"><enum>(B)</enum><text>approved by the
Food and Drug Administration.</text>
</subparagraph></paragraph><paragraph id="HF1FBDAC30EC44880AFBDF61B7900F9F1"><enum>(2)</enum><header>Conditions for
departments</header><text>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—</text>
<subparagraph id="HFEFEFBD556D642B18509166D03595C43"><enum>(A)</enum><text>to be comparable
to the system of peer review of studies and investigations used by the National
Institutes of Health; and</text>
</subparagraph><subparagraph id="HE850940168EE4EB2870067B2FC1ECA14"><enum>(B)</enum><text>assures unbiased
review of the highest ethical standards by qualified individuals who have no
interest in the outcome of the review.</text>
</subparagraph></paragraph></subsection><subsection id="H5DFB2B3470F947CFAC5248C9D6CD488"><enum>(e)</enum><header>Construction</header><text>Nothing
in this section shall be construed to limit a plan’s or issuer’s coverage with
respect to clinical trials.</text>
</subsection></section><section id="H3860BE55EA4C4427B4423E6C28793188"><enum>120.</enum><header>Required
coverage for minimum hospital stay for mastectomies and lymph node dissections
for the treatment of breast cancer and coverage for secondary
consultations</header>
<subsection id="H99084396297141BE00EAF007C50161D8"><enum>(a)</enum><header>Inpatient
care</header>
<paragraph id="H3F7B7A8AEC6644CD982347CBAE3783F9"><enum>(1)</enum><header>In
general</header><text>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—</text>
<subparagraph id="H7E80297F4DC348ACBA6CACA362086BA"><enum>(A)</enum><text>a
mastectomy;</text>
</subparagraph><subparagraph id="H2A77133F412346F48717AFDFB5CD790"><enum>(B)</enum><text>a lumpectomy;
or</text>
</subparagraph><subparagraph id="H6B529E133A3141CE9892E5CF9FDB2C57"><enum>(C)</enum><text>a lymph node
dissection for the treatment of breast cancer.</text>
</subparagraph></paragraph><paragraph id="HCAFBFD91574F4C74A56059C719C37136"><enum>(2)</enum><header>Exception</header><text>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.</text>
</paragraph></subsection><subsection id="H06B7B6F28A1F4095BC2F111EE1122F81"><enum>(b)</enum><header>Prohibition on
certain modifications</header><text>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).</text>
</subsection><subsection id="HD875D11E8A3D40A38740D7B462FB0E5"><enum>(c)</enum><header>Secondary
consultations</header>
<paragraph id="H8EE88A46BC1E4C92B0B431B402271C69"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="H497C1259CA524DF6A75B4564EDDED5E9"><enum>(2)</enum><header>Exception</header><text>Nothing
in paragraph (1) shall be construed as requiring the provision of secondary
consultations where the patient determines not to seek such a
consultation.</text>
</paragraph></subsection><subsection id="HA5BCC60C7CE44FE2AEC567C0375383AC"><enum>(d)</enum><header>Prohibition on
penalties or incentives</header><text>A group health plan, and a health
insurance issuer providing health insurance coverage, may not—</text>
<paragraph id="HB7332D24E9074659B87036C62D2BFA70"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="H7C06EB5BFE2A443398F9D8EE9808B5C7"><enum>(2)</enum><text>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</text>
</paragraph><paragraph id="H1904A310D8B3428CB74F465DEB49CCAC"><enum>(3)</enum><text>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).</text>
</paragraph></subsection></section></subtitle><subtitle id="H6AEAD63EA5EC4120AFBD3868A2C8B3CD"><enum>C</enum><header>Access to
information</header>
<section id="HA3ABE6BAD92545E100FEB562CE303DC"><enum>121.</enum><header>Patient access
to information</header>
<subsection id="HF3E42A08B09C4F78B957A2C28E871229"><enum>(a)</enum><header>Requirement</header>
<paragraph id="H2339FFB0967D4337B6FFAD6D3E5445EC"><enum>(1)</enum><header>Disclosure</header>
<subparagraph id="H641DF7E6E9EB407C96106534CA1B7391"><enum>(A)</enum><header>In
general</header><text>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—</text>
<clause id="HFA9D5171344F4D1C00A520B43BC5E306"><enum>(i)</enum><text>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;</text>
</clause><clause id="HCB1DE3CA3ECD44F8B959223E0045BAE2"><enum>(ii)</enum><text>of
such information on an annual basis—</text>
<subclause id="HB3D211CE68B34800BCC5DCF614DC1CD"><enum>(I)</enum><text>in
conjunction with the election period of the plan or coverage if the plan or
coverage has such an election period; or</text>
</subclause><subclause id="H20C0CE8123FF41A6BD8D19DC712EA865"><enum>(II)</enum><text>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</text>
</subclause></clause><clause id="H36970CE08B6240D3933075659D8BB9F3"><enum>(iii)</enum><text>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.</text>
</clause></subparagraph><subparagraph id="HDB62C2BEA5594870A6B9628347F619FF"><enum>(B)</enum><header>Participants,
beneficiaries, and enrollees</header><text>The disclosure required under
subparagraph (A) shall be provided—</text>
<clause id="HAE9CC86F5A3540B68C08EFD4EBD88C22"><enum>(i)</enum><text>jointly to each
participant, beneficiary, and enrollee who reside at the same address;
or</text>
</clause><clause id="HECE5DC1F233C4A238010BB6386057E48"><enum>(ii)</enum><text>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.</text>
</clause></subparagraph></paragraph><paragraph id="H4CF829C6C7CF4D890045B1726F6290BA"><enum>(2)</enum><header>Provision of
information</header><text>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.</text>
</paragraph></subsection><subsection id="H15FBEE1855BA471AA8377894669343D2"><enum>(b)</enum><header>Required
information</header><text>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:</text>
<paragraph id="HF6576FC98FC74781915D896B4387A3E6"><enum>(1)</enum><header>Benefits</header><text>A
description of the covered benefits, including—</text>
<subparagraph id="HAE56B95D42B74298A26C7D74DC34E54B"><enum>(A)</enum><text>any in- and
out-of-network benefits;</text>
</subparagraph><subparagraph id="H405C1256D75342789E00F7AFC71699BC"><enum>(B)</enum><text>specific
preventive services covered under the plan or coverage if such services are
covered;</text>
</subparagraph><subparagraph id="H786581B0C1554D03BA6D94FF488E90C3"><enum>(C)</enum><text>any specific
exclusions or express limitations of benefits described in section
104(d)(3)(C);</text>
</subparagraph><subparagraph id="H77F8355CE95246F39C55F5AC71F1DA5"><enum>(D)</enum><text>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</text>
</subparagraph><subparagraph id="H6DA9F5B9D6354B39BE25A3072F8BB01"><enum>(E)</enum><text>any definition of
medical necessity used in making coverage determinations by the plan, issuer,
or claims administrator.</text>
</subparagraph></paragraph><paragraph id="HE4DEA5C87D964899BC50DCAB55226948"><enum>(2)</enum><header>Cost
sharing</header><text>A description of any cost-sharing requirements,
including—</text>
<subparagraph id="H203CBE8E396E4AFF885763005E2CFBD5"><enum>(A)</enum><text>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;</text>
</subparagraph><subparagraph id="HE76FC854FF6B44878F00006ED9E1A19E"><enum>(B)</enum><text>any maximum
out-of-pocket expense for which the participant, beneficiary, or enrollee may
be liable;</text>
</subparagraph><subparagraph id="H3ACBCA7F086B44429D468659BEA3BBFC"><enum>(C)</enum><text>any cost-sharing
requirements for out-of-network benefits or services received from
nonparticipating providers; and</text>
</subparagraph><subparagraph id="H806514229C194603BCD456F200008997"><enum>(D)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="HDD0669CE80EC4FE5823818EFF2ABFD40"><enum>(3)</enum><header>Disenrollment</header><text>Information
relating to the disenrollment of a participant, beneficiary, or
enrollee.</text>
</paragraph><paragraph id="H13B30739F62C4FC7B25CFD63D87779DA"><enum>(4)</enum><header>Service
area</header><text>A description of the plan or issuer’s service area,
including the provision of any out-of-area coverage.</text>
</paragraph><paragraph id="HA5F222BB0D454E3784724D9C226683DF"><enum>(5)</enum><header>Participating
providers</header><text>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.</text>
</paragraph><paragraph id="HA0298ACC28F24FFEB0D5DA4845D6C025"><enum>(6)</enum><header>Choice of
primary care provider</header><text>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.</text>
</paragraph><paragraph id="HAF3B633BDCAE42CCA8CDDB3C08E11800"><enum>(7)</enum><header>Preauthorization
requirements</header><text>A description of the requirements and procedures to
be used to obtain preauthorization for health services, if such
preauthorization is required.</text>
</paragraph><paragraph id="H4706F77F56754B6B9542109EF956D6BC"><enum>(8)</enum><header>Experimental and
investigational treatments</header><text>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.</text>
</paragraph><paragraph id="HA220E47A9855424F0000FFEBCD5FBCFC"><enum>(9)</enum><header>Specialty
care</header><text>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.</text>
</paragraph><paragraph id="H9CD07CB1A9B244DDBEDB7E2000478715"><enum>(10)</enum><header>Clinical
trials</header><text>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.</text>
</paragraph><paragraph id="HD8B7AA8C3D934AB3A5166661EA789B96"><enum>(11)</enum><header>Prescription
drugs</header><text>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.</text>
</paragraph><paragraph id="H498D4653E512455FA16BD2AC105C5C58"><enum>(12)</enum><header>Emergency
services</header><text>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.</text>
</paragraph><paragraph id="H9C59E1D7AB814695AF2BDC9DE25F75"><enum>(13)</enum><header>Claims and
appeals</header><text>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 <act-name parsable-cite="ERISA">Employee Retirement Income Security
Act of 1974</act-name> and applicable State law.</text>
</paragraph><paragraph id="H6D4B66F967E942A2834DCC6BD1DE9F"><enum>(14)</enum><header>Advance
directives and organ donation</header><text>A description of procedures for
advance directives and organ donation decisions if the plan or issuer maintains
such procedures.</text>
</paragraph><paragraph id="H6417E935A0F740E1B37C5900E3009707"><enum>(15)</enum><header>Information on
plans and issuers</header><text>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.</text>
</paragraph><paragraph id="HF86DBF19805C434A9539B51DC1654B50"><enum>(16)</enum><header>Translation
services</header><text>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.</text>
</paragraph><paragraph id="HAE9FA00C0A7F49D7A6959D7E2C037178"><enum>(17)</enum><header>Accreditation
information</header><text>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.</text>
</paragraph><paragraph id="HF35D2C84BBAF4DC385E2CE9047AC766D"><enum>(18)</enum><header>Notice of
requirements</header><text>A description of any rights of participants,
beneficiaries, and enrollees that are established by the
<short-title>Patients’ Bill of Rights Act of
2005</short-title> (excluding those described in paragraphs (1) through (17))
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 <act-name parsable-cite="ERISA">Employee Retirement Income
Security Act of 1974</act-name> 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.</text>
</paragraph><paragraph id="HC1A89B05CF474012A2A5D6CF3EF92803"><enum>(19)</enum><header>Availability of
additional information</header><text>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.</text>
</paragraph><paragraph id="H1B8A21A3270543E5A88D196D91D3FE96"><enum>(20)</enum><header>Designated
decisionmakers</header><text>A description of the participants and
beneficiaries with respect to whom each designated decisionmaker under the plan
has assumed liability under section 502(o) of the
<act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name> and the name and address of each such decisionmaker.</text>
</paragraph></subsection><subsection id="HA92402889DF64EB6BCC4CC89C4BF7400"><enum>(c)</enum><header>Additional
information</header><text>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:</text>
<paragraph id="H382E491283C843FD88270061F13BA6F"><enum>(1)</enum><header>Status of
providers</header><text>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.</text>
</paragraph><paragraph id="HFD984CF02F544BD3ACD400902387B1B9"><enum>(2)</enum><header>Compensation
methods</header><text>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.</text>
</paragraph><paragraph id="H05F822C2D9764426A4237FB5A668DEA9"><enum>(3)</enum><header>Prescription
drugs</header><text>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.</text>
</paragraph><paragraph id="H6F472581623F4CF8B4D5874AA13B58B"><enum>(4)</enum><header>Utilization
review activities</header><text>A description of procedures used and
requirements (including circumstances, timeframes, and appeals rights) under
any utilization review program under sections 101 and 102, including any drug
formulary program under section 118.</text>
</paragraph><paragraph id="H13471C3AC45B4E14A4AC03B975B8844"><enum>(5)</enum><header>External appeals
information</header><text>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.</text>
</paragraph></subsection><subsection id="HE25D9ACAB3CC4612B64BD7004CECF040"><enum>(d)</enum><header>Manner of
disclosure</header><text>The information described in this section shall be
disclosed in an accessible medium and format that is calculated to be
understood by a participant or enrollee.</text>
</subsection><subsection id="HD580082538DC463A84BB25003994AEBD"><enum>(e)</enum><header>Rules of
construction</header><text>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—</text>
<paragraph id="HDAEF49EAD33B4A57B32BDBF08E74CA77"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="H70BBC99F43B247DB873E4596B5004272"><enum>(2)</enum><text>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—</text>
<subparagraph id="H27A8D5285AA3441D93DEEE5E64CF41D2"><enum>(A)</enum><text>the disclosure of
such information in such form is in accordance with requirements as the
appropriate Secretary may impose, and</text>
</subparagraph><subparagraph id="HC388099F6C6D4DCD9910B77685DCB4E4"><enum>(B)</enum><text>in connection with
any such disclosure of information through the Internet or other electronic
media—</text>
<clause id="HD3A5C28853B74556A4025661E4663B01"><enum>(i)</enum><text>the
recipient has affirmatively consented to the disclosure of such information in
such form,</text>
</clause><clause id="H85530E7B95EF4250A46917E0C5C19DB"><enum>(ii)</enum><text>the
recipient is capable of accessing the information so disclosed on the
recipient’s individual workstation or at the recipient’s home,</text>
</clause><clause id="H50473FB8400149979B79E9E7F31DAED5"><enum>(iii)</enum><text>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</text>
</clause><clause id="H836D7A9BB6894041866861AC674BD773"><enum>(iv)</enum><text>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.</text>
</clause></subparagraph></paragraph></subsection></section></subtitle><subtitle id="H4A19C31E389A408F927B4398EA61DA98"><enum>D</enum><header>Protecting the
doctor-patient relationship</header>
<section id="H0CE83556498442FC8DD8ED099F53C92"><enum>131.</enum><header>Prohibition of
interference with certain medical communications</header>
<subsection id="H137D997324C14BC900B21B46135DE9A0"><enum>(a)</enum><header>General
rule</header><text>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.</text>
</subsection><subsection id="H2DC1FC076774455B8E95438CB987683B"><enum>(b)</enum><header>Nullification</header><text>Any
contract provision or agreement that restricts or prohibits medical
communications in violation of subsection (a) shall be null and void.</text>
</subsection></section><section id="H9C68C3E0B4C9469ABA004B549306FB38"><enum>132.</enum><header>Prohibition of
discrimination against providers based on licensure</header>
<subsection id="H999DDB09063F4D89ACE28B6998C02712"><enum>(a)</enum><header>In
general</header><text>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.</text>
</subsection><subsection id="H86414BBAB43D482EAA4215E5D19BDDE6"><enum>(b)</enum><header>Construction</header><text>Subsection
(a) shall not be construed—</text>
<paragraph id="H0DEA27FD7AA14BA3A140BD5567000012"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="HD984963D4C114B28902188F68C1005C"><enum>(2)</enum><text>to
override any State licensure or scope-of-practice law; or</text>
</paragraph><paragraph id="H487C8E50C21245D1A38DDF00BD23771B"><enum>(3)</enum><text>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.</text>
</paragraph></subsection></section><section id="H1101EB1E76604DAF9B48D4C51EDB3494"><enum>133.</enum><header>Prohibition
against improper incentive arrangements</header>
<subsection id="H2598E04B3719449FAC9119A15F2DB8E1"><enum>(a)</enum><header>In
general</header><text>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 1852(j)(4) of the
<act-name parsable-cite="SSA">Social Security Act</act-name>) 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.</text>
</subsection><subsection id="H6A43CF18ED71409F9C04A670C0397D9B"><enum>(b)</enum><header>Application</header><text>For
purposes of carrying out paragraph (1), any reference in section 1852(j)(4) of
the <act-name parsable-cite="SSA">Social Security Act</act-name> to the
Secretary, a MedicareAdvantage 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.</text>
</subsection><subsection id="HE2402D9C02EF4A0686F945455420C03C"><enum>(c)</enum><header>Construction</header><text>Nothing
in this section shall be construed as prohibiting all capitation and similar
arrangements or all provider discount arrangements.</text>
</subsection></section><section id="H6549AB19215E47D3005FFEB7A2ACA8CB"><enum>134.</enum><header>Payment of
claims</header><text display-inline="no-display-inline">A group health plan,
and a health insurance issuer offering 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 that is no less protective than the
provisions of section 1842(c)(2) of the <act-name parsable-cite="SSA">Social
Security Act</act-name> (42 U.S.C. 1395u(c)(2)).</text>
</section><section id="H5606E6FD6F2D415289E613B483473743"><enum>135.</enum><header>Protection for
patient advocacy</header>
<subsection id="H12C5573DD0D54F8C94DEC4D1A45596B7"><enum>(a)</enum><header>Protection for
use of utilization review and grievance process</header><text>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.</text>
</subsection><subsection id="H25828B28347C4FA394CB29DB3FB29437"><enum>(b)</enum><header>Protection for
quality advocacy by health care professionals</header>
<paragraph id="H8684C94D0CE84BDAB69862145E46F96D"><enum>(1)</enum><header>In
general</header><text>A group health plan and a health insurance issuer may not
retaliate or discriminate against a protected health care professional because
the professional in good faith—</text>
<subparagraph id="H592D7AF821AF4576987FB63FD7EA41F"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="H7431E44137C44B03846DDEB300ED159C"><enum>(B)</enum><text>initiates,
cooperates, or otherwise participates in an investigation or proceeding by such
an agency with respect to such care, services, or conditions.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">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.</continuation-text></paragraph><paragraph id="HE80FE101F4F746C3A9741409B5B6BFFD"><enum>(2)</enum><header>Good faith
action</header><text>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—</text>
<subparagraph id="H76F1AECF9AD542B7BB00BCEED4B89437"><enum>(A)</enum><text>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;</text>
</subparagraph><subparagraph id="H6829F1E4068C42CBB4C8C4DA3C4D005B"><enum>(B)</enum><text>the professional
reasonably believes the information to be true;</text>
</subparagraph><subparagraph id="HFB552C66E4C44CEF8596B94BB759C27"><enum>(C)</enum><text>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</text>
</subparagraph><subparagraph id="H5C58394440CC417CB3191461C3B7D5D5"><enum>(D)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="H43A7DD0199DA4EDFB5E38B9B8F2D7BBC"><enum>(3)</enum><header>Exception and
special rule</header>
<subparagraph id="HB87EC6AB9B924D5BBDB8E8E10028B2EB"><enum>(A)</enum><header>General
exception</header><text>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.</text>
</subparagraph><subparagraph id="H14FA0E18117F4B0295D101E3EB6250D3"><enum>(B)</enum><header>Notice of
internal procedures</header><text>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.</text>
</subparagraph><subparagraph id="H1BD04B76383643DDB2075B6E242E1BF3"><enum>(C)</enum><header>Internal
procedure exception</header><text>Subparagraph (D) of paragraph (2) also shall
not apply if—</text>
<clause id="H02DEB94F621E42DA003407EC2885634B"><enum>(i)</enum><text>the
disclosure relates to an imminent hazard of loss of life or serious injury to a
patient;</text>
</clause><clause id="H01CF2E557E1D4B948E33F65DDC2F7492"><enum>(ii)</enum><text>the
disclosure is made to an appropriate private accreditation body pursuant to
disclosure procedures established by the body; or</text>
</clause><clause id="H00F038E099884E36849B85B5C9B0030"><enum>(iii)</enum><text>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.</text>
</clause></subparagraph></paragraph><paragraph id="H498B4093FF5546D2BB8DDCC045A1D200"><enum>(4)</enum><header>Additional
considerations</header><text>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.</text>
</paragraph><paragraph id="HB9FEBE77D85D44288240F88C6BF864"><enum>(5)</enum><header>Notice</header><text>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.</text>
</paragraph><paragraph id="H6ADAB64630E444E695158737DB34F400"><enum>(6)</enum><header>Constructions</header>
<subparagraph id="HED67E3BFD8284C3A82CF5B88B8722BAA"><enum>(A)</enum><header>Determinations
of coverage</header><text>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.</text>
</subparagraph><subparagraph id="H45285CC5A5754123A4823EA4E7004639"><enum>(B)</enum><header>Enforcement of
peer review protocols and internal procedures</header><text>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.</text>
</subparagraph><subparagraph id="H6AAD344AA21A45CC00DC6441B2E7002E"><enum>(C)</enum><header>Relation to
other rights</header><text>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.</text>
</subparagraph></paragraph><paragraph id="H04FB4D4F276F49A892F32E4CC963DA75"><enum>(7)</enum><header>Protected health
care professional defined</header><text>For purposes of this subsection, the
term <term>protected health care professional</term> means an individual who is
a licensed or certified health care professional and who—</text>
<subparagraph id="H0112732798464E77AF4D3B173BDA8040"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="H1194E21BF06A45E8B467A8556FA628B0"><enum>(B)</enum><text>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.</text>
</subparagraph></paragraph></subsection></section></subtitle><subtitle id="HFCF76C46461A42D285BB87D54E6C6F97"><enum>E</enum><header>Definitions</header>
<section id="HE38C2B178C8E4D88875556D4CBC58780"><enum>151.</enum><header>Definitions</header>
<subsection id="H6289B758B540404CAF233BB4AD2B2753"><enum>(a)</enum><header>Incorporation of
general definitions</header><text>Except as otherwise provided, the provisions
of section 2791 of the <act-name parsable-cite="PHSA">Public Health Service
Act</act-name> shall apply for purposes of this title in the same manner as
they apply for purposes of title XXVII of such Act.</text>
</subsection><subsection id="HA7606EBA9093492FB1E848C5C1832FF5"><enum>(b)</enum><header>Secretary</header><text>Except
as otherwise provided, the term <term>Secretary</term> means the Secretary of
Health and Human Services, in consultation with the Secretary of Labor and the
term <term>appropriate Secretary</term> means the Secretary of Health and Human
Services in relation to carrying out this title under sections 2706 and 2751 of
the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> and the
Secretary of Labor in relation to carrying out this title under section 714 of
the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name>.</text>
</subsection><subsection id="H5872AC93828E488498C9A1681DD2A900"><enum>(c)</enum><header>Additional
definitions</header><text>For purposes of this title:</text>
<paragraph id="HE44AE13B1F5345CCB29600502F1971C4"><enum>(1)</enum><header>Applicable
authority</header><text>The term <term>applicable authority</term>
means—</text>
<subparagraph id="H26B2B46C98294950AE1880DB3CCC282"><enum>(A)</enum><text>in the case of a
group health plan, the Secretary of Health and Human Services and the Secretary
of Labor; and</text>
</subparagraph><subparagraph id="H28D8F7DCCFC648A7AFC9FD643123F981"><enum>(B)</enum><text>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
<act-name parsable-cite="PHSA">Public Health Service Act</act-name>), 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
<act-name parsable-cite="PHSA">Public Health Service Act</act-name>.</text>
</subparagraph></paragraph><paragraph id="HF38483E9308548409BA4AA222178604F"><enum>(2)</enum><header>Enrollee</header><text>The
term <term>enrollee</term> means, with respect to health insurance coverage
offered by a health insurance issuer, an individual enrolled with the issuer to
receive such coverage.</text>
</paragraph><paragraph id="HF6E304A332EC48F293F1602DB3B29B13"><enum>(3)</enum><header>Group health
plan</header><text>The term <term>group health plan</term> has the meaning
given such term in section 733(a) of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name>, 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.</text>
</paragraph><paragraph id="HEF7FD581C3134376BA4E255B9FFAA9E1"><enum>(4)</enum><header>Health care
professional</header><text>The term <term>health care professional</term> 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.</text>
</paragraph><paragraph id="H9A8C83DB67F44BB90000CD3614ECA42E"><enum>(5)</enum><header>Health care
provider</header><text>The term <term>health care provider</term> 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.</text>
</paragraph><paragraph id="HEACA137D0FDC4BF6885D4C61FFF5A052"><enum>(6)</enum><header>Network</header><text>The
term <term>network</term> 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.</text>
</paragraph><paragraph id="H907F547932AC4279AE36E85CC9947066"><enum>(7)</enum><header>Nonparticipating</header><text>The
term <term>nonparticipating</term> 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.</text>
</paragraph><paragraph id="HA7EBC3C98EF448EDB8CB166FF7ACF538"><enum>(8)</enum><header>Participating</header><text>The
term <term>participating</term> 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.</text>
</paragraph><paragraph id="H59C429D097894F2D0022842DACF80000"><enum>(9)</enum><header>Prior
authorization</header><text>The term <term>prior authorization</term> means the
process of obtaining prior approval from a health insurance issuer or group
health plan for the provision or coverage of medical services.</text>
</paragraph><paragraph id="HFAF0BF25C92141C09DBA133719EF0085"><enum>(10)</enum><header>Terms and
conditions</header><text>The term <term>terms and conditions</term> includes,
with respect to a group health plan or health insurance coverage, requirements
imposed under this title with respect to the plan or coverage.</text>
</paragraph></subsection></section><section id="HC670E06E47EF48D882558B34BCE200D3"><enum>152.</enum><header>Preemption;
State flexibility; construction</header>
<subsection id="H375E761A628548E89F00C7D8CBBAB555"><enum>(a)</enum><header>Continued
applicability of State law with respect to health insurance issuers</header>
<paragraph id="H5E27FA9DA2294DC39F3BC546731B0973"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="HB3256D144DE34BBF825F2B9122C65E06"><enum>(2)</enum><header>Continued
preemption with respect to group health plans</header><text>Nothing in this
title shall be construed to affect or modify the provisions of section 514 of
the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name> with respect to group health plans.</text>
</paragraph><paragraph id="HAD4D37237D094E7984CEFB086FEF3EE0"><enum>(3)</enum><header>Construction</header><text>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.</text>
</paragraph></subsection><subsection id="HD558BE3C93104389008CC6D0419B3BFB"><enum>(b)</enum><header>Application of
substantially compliant State laws</header>
<paragraph id="H7D1BE7010EB64EB7BF9DABE65096CE71"><enum>(1)</enum><header>In
general</header><text>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 substantially complies (within the meaning of subsection (c)) with 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 compliant requirements), in applying the
requirements of this title under section 2707 and 2753 (as applicable) of the
<act-name parsable-cite="PHSA">Public Health Service Act</act-name> (as added
by title II), subject to subsection (a)(2)—</text>
<subparagraph id="H2CC21BD77D5F41B4B89066B345907CA1"><enum>(A)</enum><text>the State law
shall not be treated as being superseded under subsection (a); and</text>
</subparagraph><subparagraph id="H65C7FD89507547D18F71F8545897DADB"><enum>(B)</enum><text>the State law
shall apply instead of the patient protection requirement otherwise applicable
with respect to health insurance coverage and non-Federal governmental
plans.</text>
</subparagraph></paragraph><paragraph id="H35CE3F2C0BC34A09981D23B59FFAE477"><enum>(2)</enum><header>Limitation</header><text>In
the case of a group health plan covered under title I of the
<act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name>, paragraph (1) shall be construed to apply only with respect to
the health insurance coverage (if any) offered in connection with the
plan.</text>
</paragraph><paragraph id="HBFB14CB73B404250B8BC5425482E8F16"><enum>(3)</enum><header>Definitions</header><text>In
this section:</text>
<subparagraph id="HB83FCE9E295F48819E6C4BA287C24708"><enum>(A)</enum><header>Patient
protection requirement</header><text>The term <term>patient protection
requirement</term> 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.</text>
</subparagraph><subparagraph id="H1B612EBF8B82442E9CFA4EF105527AD"><enum>(B)</enum><header>Substantially
compliant</header><text>The terms “substantially compliant”, substantially
complies”, or “substantial compliance” with respect to a State law, mean that
the State law has the same or similar features as the patient protection
requirements and has a similar effect.</text>
</subparagraph></paragraph></subsection><subsection id="H64FF087AEE7B4BC49DECD154F6C400B0"><enum>(c)</enum><header>Determinations
of substantial compliance</header>
<paragraph id="HD08C9499952E4B01BEF6F738B1E409B6"><enum>(1)</enum><header>Certification by
States</header><text>A State may submit to the Secretary a certification that a
State law provides for patient protections that are at least substantially
compliant with 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).</text>
</paragraph><paragraph id="H90815646D6A34F9E98F0816320009290"><enum>(2)</enum><header>Review</header>
<subparagraph id="H21FED3A9565F4703AEC4ABDAE4DFB885"><enum>(A)</enum><header>In
general</header><text>The Secretary shall promptly review a certification
submitted under paragraph (1) with respect to a State law to determine if the
State law substantially complies with the patient protection requirement (or
requirements) to which the law relates.</text>
</subparagraph><subparagraph id="HD82C782E3569475895C89EC58C5DA6DA"><enum>(B)</enum><header>Approval
deadlines</header>
<clause id="HE275C75E801C4E7797F9582B62CD964F"><enum>(i)</enum><header>Initial
review</header><text>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).</text>
</clause><clause id="H383CF3DDBD0B465A95C9C700D9D4F2D"><enum>(ii)</enum><header>Additional
information</header><text>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.</text>
</clause></subparagraph></paragraph><paragraph id="H0E242B6964764910B185349E7DCC81F9"><enum>(3)</enum><header>Approval</header>
<subparagraph id="HB495173505B847F583DC02EC6EA0F8E7"><enum>(A)</enum><header>In
general</header><text>The Secretary shall approve a certification under
paragraph (1) unless—</text>
<clause id="H4E9B185083A0417BA5C5E5BF25827300"><enum>(i)</enum><text>the
State fails to provide sufficient information to enable the Secretary to make a
determination under paragraph (2)(A); or</text>
</clause><clause id="H2D22B86805C54EB381A1AE38D8002C4E"><enum>(ii)</enum><text>the
Secretary determines that the State law involved does not provide for patient
protections that substantially comply with the patient protection requirement
(or requirements) to which the law relates.</text>
</clause></subparagraph><subparagraph id="H945C3CCCA3A74392971540EA80A22935"><enum>(B)</enum><header>State
challenge</header><text>A State that has a certification disapproved by the
Secretary under subparagraph (A) may challenge such disapproval in the
appropriate United States district court.</text>
</subparagraph><subparagraph id="HF82349533AA1488900CA935394C6EED3"><enum>(C)</enum><header>Deference to
States</header><text>With respect to a certification submitted under paragraph
(1), the Secretary shall give deference to the State’s interpretation of the
State law involved with respect to the patient protection involved.</text>
</subparagraph><subparagraph id="HBFBF92C4297D4D2BB3A059B5A075FE98"><enum>(D)</enum><header>Public
notification</header><text>The Secretary shall—</text>
<clause id="H781851F6669B46E58E7092BE447D009D"><enum>(i)</enum><text>provide a State
with a notice of the determination to approve or disapprove a certification
under this paragraph;</text>
</clause><clause id="H4C367D17F48E42A38186FBBECAC2447"><enum>(ii)</enum><text>promptly publish
in the Federal Register a notice that a State has submitted a certification
under paragraph (1);</text>
</clause><clause id="H8116BC0DCC8748F6B2E74864FFC3A9E3"><enum>(iii)</enum><text>promptly publish
in the Federal Register the notice described in clause (i) with respect to the
State; and</text>
</clause><clause id="HCA8574B3856C43D2A9B335110032BF52"><enum>(iv)</enum><text>annually publish
the status of all States with respect to certifications.</text>
</clause></subparagraph></paragraph><paragraph id="HEE84DE85D318467E8CA3BB89F24CD089"><enum>(4)</enum><header>Construction</header><text>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 compliance.</text>
</paragraph><paragraph id="H5910612D1B284AA6A62986867267A209"><enum>(5)</enum><header>Petitions</header>
<subparagraph id="H872876F6CCB14A69AE5486099D76CB35"><enum>(A)</enum><header>Petition
process</header><text>Effective on the date on which the provisions of this Act
become effective, as provided for in section 601, a group health plan, health
insurance issuer, participant, beneficiary, or enrollee may submit a petition
to the Secretary for an advisory opinion as to whether or not a standard or
requirement under a State law applicable to the plan, issuer, participant,
beneficiary, or enrollee that is not the subject of a certification under this
subsection, is superseded under subsection (a)(1) because such standard or
requirement prevents the application of a requirement of this title.</text>
</subparagraph><subparagraph id="HEA5944E8A64A433488FEC00ABD4E4C4"><enum>(B)</enum><header>Opinion</header><text>The
Secretary shall issue an advisory opinion with respect to a petition submitted
under subparagraph (A) within the 60-day period beginning on the date on which
such petition is submitted.</text>
</subparagraph></paragraph></subsection><subsection id="HF0038505ACBF41FEB7BF68D580E9734C"><enum>(d)</enum><header>Definitions</header><text>For
purposes of this section:</text>
<paragraph id="H80407DDF4BB14569A9A97808AE51D545"><enum>(1)</enum><header>State
law</header><text>The term <term>State law</term> 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.</text>
</paragraph><paragraph id="H102C25FCB7264CC499C319A61844E4AF"><enum>(2)</enum><header>State</header><text>The
term <term>State</term> 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.</text>
</paragraph></subsection></section><section id="HE1C39FF8135249ECBD856C18A46DA472"><enum>153.</enum><header>Exclusions</header>
<subsection id="H63B6D4CFDC464596A4B7FC2CB52FDD6D"><enum>(a)</enum><header>No benefit
requirements</header><text>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.</text>
</subsection><subsection id="HC5F1DDE3C68742BDBEAA8D026C8F4C00"><enum>(b)</enum><header>Exclusion from
access to care managed care provisions for fee-for-service coverage</header>
<paragraph id="HBA3FB69547FC4A8500905E2EC5CD994"><enum>(1)</enum><header>In
general</header><text>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)).</text>
</paragraph><paragraph id="H3538BFAFEC444F92B512C9AB6015ADDB"><enum>(2)</enum><header>Fee-for-service
coverage defined</header><text>For purposes of this subsection, the term
<term>fee-for-service coverage</term> means coverage under a group health plan
or health insurance coverage that—</text>
<subparagraph id="H48E88BEE689D4A67B3BA5C6FE7E3A224"><enum>(A)</enum><text>reimburses
hospitals, health professionals, and other providers on a fee-for-service basis
without placing the provider at financial risk;</text>
</subparagraph><subparagraph id="H2B6CB7D02B8A4AB488FBA3454916425B"><enum>(B)</enum><text>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;</text>
</subparagraph><subparagraph id="HE71D24BCDCE9426185D958AC98EC8C6C"><enum>(C)</enum><text>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</text>
</subparagraph><subparagraph id="HA93190654FA84048AE23BC22188CC42C"><enum>(D)</enum><text>for which the plan
or issuer does not require prior authorization before providing for any health
care services.</text>
</subparagraph></paragraph></subsection></section><section id="HADE17C59D1BD46959E2CBECC1B402481"><enum>154.</enum><header>Treatment of
excepted benefits</header>
<subsection id="HA001E8A2DF254D97B73FD89152C7B90"><enum>(a)</enum><header>In
general</header><text>The requirements of this title and the provisions of
sections 502(a)(1)(C), 502(n), and 514(d) of the
<act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name> (added by section 402) shall not apply to excepted benefits (as
defined in section 733(c) of such Act), other than benefits described in
section 733(c)(2)(A) of such Act, in the same manner as the provisions of part
7 of subtitle B of title I of such Act do not apply to such benefits under
subsections (b) and (c) of section 732 of such Act.</text>
</subsection><subsection id="H6C61E937E4C04D21AB7D82164624D5AB"><enum>(b)</enum><header>Coverage of
certain limited scope plans</header><text>Only for purposes of applying the
requirements of this title under sections 2707 and 2753 of the
<act-name parsable-cite="PHSA">Public Health Service Act</act-name>, section
714 of the <act-name parsable-cite="ERISA">Employee Retirement Income Security
Act of 1974</act-name>, and section 9813 of the Internal Revenue Code of 1986,
the following sections shall be deemed not to apply:</text>
<paragraph id="H53C5320A4F464504A54745EB65217265"><enum>(1)</enum><text>Section
2791(c)(2)(A) of the <act-name parsable-cite="PHSA">Public Health Service
Act</act-name>.</text>
</paragraph><paragraph id="H6FBC6B39960B49FB9CD393324B37AB07"><enum>(2)</enum><text>Section
733(c)(2)(A) of the <act-name parsable-cite="ERISA">Employee Retirement Income
Security Act of 1974</act-name>.</text>
</paragraph><paragraph id="H17630CFAF39C4D10979E36CCE0A34C82"><enum>(3)</enum><text>Section
9832(c)(2)(A) of the Internal Revenue Code of 1986.</text>
</paragraph></subsection></section><section id="HAD4D1701579748BE0038B4B3512832A1"><enum>155.</enum><header>Regulations</header><text display-inline="no-display-inline">The Secretaries of Health and Human
Services, Labor, and the Treasury 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 <act-name parsable-cite="HIPAA">Health
Insurance Portability and Accountability Act of 1996</act-name>. Such
Secretaries may promulgate any interim final rules as the Secretaries determine
are appropriate to carry out this title.</text>
</section><section id="H8741DF706A1841F3AC37CC62DB19F91"><enum>156.</enum><header>Incorporation
into plan or coverage documents</header><text display-inline="no-display-inline">The requirements of this title with respect
to a group health plan or health insurance coverage are, subject to section
154, 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.</text>
</section><section id="H86703E90F1D349249FA686F7C22B32E9"><enum>157.</enum><header>Preservation of
protections</header>
<subsection id="HC86BBB81E52F45D38C8985AC3BFEEF4E"><enum>(a)</enum><header>In
general</header><text>The rights under this Act (including the right to
maintain a civil action and any other rights under the amendments made by this
Act) may not be waived, deferred, or lost pursuant to any agreement not
authorized under this Act.</text>
</subsection><subsection id="H788DEEECDCDB479C8900F28424EB8D04"><enum>(b)</enum><header>Exception</header><text>Subsection
(a) shall not apply to an agreement providing for arbitration or participation
in any other nonjudicial procedure to resolve a dispute if the
agreement—</text>
<paragraph id="H0E9308D605B04608908501A2EBCE72C0"><enum>(1)</enum><text>is entered into
knowingly and voluntarily by the parties involved after the dispute has arisen;
or</text>
</paragraph><paragraph id="H9FF7BA3BA26D407CB5E5865EF34238E"><enum>(2)</enum><text>is
pursuant to the terms of a collective bargaining agreement.</text>
</paragraph><continuation-text continuation-text-level="subsection">Nothing in
this subsection shall be construed to permit the waiver of the requirements of
sections 103 and 104 (relating to internal and external review).</continuation-text></subsection></section></subtitle><enum>II</enum><header>Application of
quality care standards to group health plans and health insurance coverage
under the <act-name parsable-cite="PHSA">Public Health Service
Act</act-name></header>
<section id="H275D1908DE6645A3A5E3D502225364A4"><enum>201.</enum><header>Application to
group health plans and group health insurance coverage</header>
<subsection id="HAF3231A50CD740C7AFF4EE618B5DE2BD"><enum>(a)</enum><header>In
general</header><text>Subpart 2 of part A of title XXVII of the
<act-name parsable-cite="PHSA">Public Health Service Act</act-name> is amended
by adding at the end the following new section:</text>
<quoted-block act-name="Public Health Service Act" id="HB6AB856E4D2E4668B3006D3CEFEBF8C">
<section id="H013FAE75221B497AAE3E787D43AC84A6"><enum>2707.</enum><header>Patient
protection standards</header><text display-inline="no-display-inline">Each
group health plan shall comply with patient protection requirements under title
I of the <short-title>Patients’ Bill of Rights Act of
2005</short-title>, 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.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HACBB43A0C9A447ABB087B59D00790731"><enum>(b)</enum><header>Conforming
amendment</header><text>Section 2721(b)(2)(A) of such Act (42 U.S.C.
300gg–21(b)(2)(A)) is amended by inserting <quote>(other than section
2707)</quote> after <quote>requirements of such subparts</quote>.</text>
</subsection></section><section id="HCEFFED7E5841432E9462FB6800306829"><enum>202.</enum><header>Application to
individual health insurance coverage</header><text display-inline="no-display-inline">Part B of title XXVII of the
<act-name parsable-cite="PHSA">Public Health Service Act</act-name> is amended
by inserting after section 2752 the following new section:</text>
<quoted-block act-name="Public Health Service Act" id="H7530DC2DA47E402BB6E820CFE8F7F3D6">
<section id="H1C86625C7F5D4DCBA130EA672E8EC00"><enum>2753.</enum><header>Patient
protection standards</header><text display-inline="no-display-inline">Each
health insurance issuer shall comply with patient protection requirements under
title I of the <short-title>Patients’ Bill of Rights Act
of 2005</short-title> with respect to individual health insurance coverage it
offers, and such requirements shall be deemed to be incorporated into this
subsection.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="HCADD96DF8E0B4DB4B1F91D2F009780B8"><enum>203.</enum><header>Cooperation
between Federal and State authorities</header><text display-inline="no-display-inline">Part C of title XXVII of the
<act-name parsable-cite="PHSA">Public Health Service Act</act-name> (42 U.S.C.
300gg–91 et seq.) is amended by adding at the end the following:</text>
<quoted-block act-name="Public Health Service Act" id="H77D6D37C1DF74EBA9B8B4BF4938600FC">
<section id="H2BA4CADD2FD7498898F0083CB31E300"><enum>2793.</enum><header>Cooperation
between Federal and State authorities</header>
<subsection id="HD4621AAEAC4D49169042426EC80000E2"><enum>(a)</enum><header>Agreement with
States</header><text>A State may enter into an agreement with the Secretary for
the delegation to the State of some or all of the Secretary’s authority under
this title to enforce the requirements applicable under title I of the
<short-title>Patients’ Bill of Rights Act of
2005</short-title> 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.</text>
</subsection><subsection id="H270CB369D5294246BF041827C56D8E72"><enum>(b)</enum><header>Delegations</header><text>Any
department, agency, or instrumentality of a State to which authority is
delegated pursuant to an agreement entered into under this section may, if
authorized under State law and to the extent consistent with such agreement,
exercise the powers of the Secretary under this title which relate to such
authority.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>III</enum><header>Application of
patient protection standards to Federal health insurance programs</header>
<section id="HDF3ED6558D824D97B1E27244BB570969"><enum>301.</enum><header>Application of
patient protection standards to Federal health insurance programs</header>
<subsection id="HEA25FAF09141424799899498BEA458D2"><enum>(a)</enum><header>Sense of
Congress</header><text>It is the sense of Congress that enrollees in Federal
health insurance programs should have the same rights and privileges as those
afforded under title I and under the amendments made by title IV to
participants and beneficiaries under group health plans.</text>
</subsection><subsection id="H27EBC827BCF04AB2AC3F21F7AF23D140"><enum>(b)</enum><header>Conforming
Federal health insurance programs</header><text>It is the sense of Congress
that the President should require, by executive order, the Federal official
with authority over each Federal health insurance program, to the extent
feasible, to take such steps as are necessary to implement the rights and
privileges described in subsection (a) with respect to such program.</text>
</subsection><subsection id="H33BD5798E4504CB1BBFB534EECAF37E7"><enum>(c)</enum><header>GAO report on
additional steps required</header><text>Not later than 1 year after the date of
the enactment of this Act, the Comptroller General of the United States shall
submit to Congress a report on statutory changes that are required to implement
such rights and privileges in a manner that is consistent with the missions of
the Federal health insurance programs and that avoids unnecessary duplication
or disruption of such programs.</text>
</subsection><subsection id="H291DCB81142F4B4392FD2E739B73F04E"><enum>(d)</enum><header>Federal health
insurance program</header><text>In this section, the term <term>Federal health
insurance program</term> means a Federal program that provides creditable
coverage (as defined in section 2701(c)(1) of the
<act-name parsable-cite="PHSA">Public Health Service Act</act-name>) and
includes a health program of the Department of Veterans Affairs.</text>
</subsection></section><enum>IV</enum><header>Amendments to the
<act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name></header>
<section id="H35E797B3B4DD40C2AE6368B24DA05B76"><enum>401.</enum><header>Application of
patient protection standards to group health plans and group health insurance
coverage under the <act-name parsable-cite="ERISA">Employee Retirement Income
Security Act of 1974</act-name></header><text display-inline="no-display-inline">Subpart B of part 7 of subtitle B of title I
of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act
of 1974</act-name> is amended by adding at the end the following new
section:</text>
<quoted-block act-name="Employee Retirement Income Security Act of 1974" id="H6D360BC5A4DA41C2BE4946DE08E000DA">
<section id="HEDB4427CB56A453C8B46899397554183"><enum>714.</enum><header>Patient
protection standards</header>
<subsection id="H8EB00F96791E4B5C00ECC6937EFA834D"><enum>(a)</enum><header>In
general</header><text>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
<short-title>Patients’ Bill of Rights Act of
2005</short-title> (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.</text>
</subsection><subsection id="HF511F4ABF0B4494EAA12BF045BCEF64"><enum>(b)</enum><header>Plan satisfaction
of certain requirements</header>
<paragraph id="H6EEF554A54354FCE8FA4AC14A8A1BE52"><enum>(1)</enum><header>Satisfaction of
certain requirements through insurance</header><text>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
<short-title>Patients’ Bill of Rights Act of
2005</short-title> 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:</text>
<subparagraph id="HB05753BD2ADB4D8ABF9FA5CFE196D3CC"><enum>(A)</enum><text>Section 111
(relating to consumer choice option).</text>
</subparagraph><subparagraph id="H9EC2D2F907FB4B3CBFC15B6D6D576328"><enum>(B)</enum><text>Section 112
(relating to choice of health care professional).</text>
</subparagraph><subparagraph id="H68E00799837B43269F521BD978891472"><enum>(C)</enum><text>Section 113
(relating to access to emergency care).</text>
</subparagraph><subparagraph id="H7419334678034C3198616B90001384D"><enum>(D)</enum><text>Section 114
(relating to timely access to specialists).</text>
</subparagraph><subparagraph id="H36872695ED8B48C792428B27C66596C5"><enum>(E)</enum><text>Section 115
(relating to patient access to obstetrical and gynecological care).</text>
</subparagraph><subparagraph id="HAD2ECF7EDE4148B0AD29A2D78C636CE8"><enum>(F)</enum><text>Section 116
(relating to access to pediatric care).</text>
</subparagraph><subparagraph id="H41D5D187FBB7489EBA82EB00D44646DA"><enum>(G)</enum><text>Section 117
(relating to continuity of care), but only insofar as a replacement issuer
assumes the obligation for continuity of care.</text>
</subparagraph><subparagraph id="HD69EDB6D0AC843C880B391212FF70EC"><enum>(H)</enum><text>Section 118
(relating to access to needed prescription drugs).</text>
</subparagraph><subparagraph id="H9600C3D1E72942618E53699D15897C9B"><enum>(I)</enum><text>Section 119
(relating to coverage for individuals participating in approved clinical
trials).</text>
</subparagraph><subparagraph id="H21D146D0A33044E98FEDE222F23002C"><enum>(J)</enum><text>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).</text>
</subparagraph><subparagraph id="H393B99B969734831BC0055082C70E06D"><enum>(K)</enum><text>Section 134
(relating to payment of claims).</text>
</subparagraph></paragraph><paragraph id="H6C64921AB11B46E188DDA883A715CF85"><enum>(2)</enum><header>Information</header><text>With
respect to information required to be provided or made available under section
121 of the <short-title>Patients’ Bill of Rights Act of
2005</short-title>, 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.</text>
</paragraph><paragraph id="HA5A2737B70FE4FC196295CE1BD50B49F"><enum>(3)</enum><header>Internal
appeals</header><text>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.</text>
</paragraph><paragraph id="H517196D1A18547B688795C637C580031"><enum>(4)</enum><header>External
appeals</header><text>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.</text>
</paragraph><paragraph id="H626195B5AEB541E2B6E486151274CCA1"><enum>(5)</enum><header>Application to
prohibitions</header><text>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 <short-title>Patients’ Bill of Rights Act of
2005</short-title>, the group health plan shall not be liable for such
violation unless the plan caused such violation:</text>
<subparagraph id="HB86E7BB946E34FD7AA18A5F5CB6BCA13"><enum>(A)</enum><text>Section 131
(relating to prohibition of interference with certain medical
communications).</text>
</subparagraph><subparagraph id="HBCDD40A05E9640C6ADB1A1E6AD3E897B"><enum>(B)</enum><text>Section 132
(relating to prohibition of discrimination against providers based on
licensure).</text>
</subparagraph><subparagraph id="H8254CB6064B14BE38E38CEA63E9205BB"><enum>(C)</enum><text>Section 133
(relating to prohibition against improper incentive arrangements).</text>
</subparagraph><subparagraph id="H6BA3917B45B246E88363E241BCAB1FAA"><enum>(D)</enum><text>Section 135
(relating to protection for patient advocacy).</text>
</subparagraph></paragraph><paragraph id="H9B265BE0A4BB406B918D47CA09931628"><enum>(6)</enum><header>Construction</header><text>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.</text>
</paragraph><paragraph id="H120B3E5D6A4840FA8E6F93E59EFF81F1"><enum>(7)</enum><header>Treatment of
substantially compliant State laws</header><text>For purposes of applying this
subsection in connection with health insurance coverage, any reference in this
subsection to a requirement in a section or other provision in the
<short-title>Patients’ Bill of Rights Act of
2005</short-title> with respect to a health insurance issuer is deemed to
include a reference to a requirement under a State law that substantially
complies (as determined under section 152(c) of such Act) with the requirement
in such section or other provisions.</text>
</paragraph><paragraph id="HEB7133ABF3CC45E7B5FDFA7693003B5"><enum>(8)</enum><header>Application to
certain prohibitions against retaliation</header><text>With respect to
compliance with the requirements of section 135(b)(1) of the
<short-title>Patients’ Bill of Rights Act of
2005</short-title>, for purposes of this subtitle the term <term>group health
plan</term> is deemed to include a reference to an institutional health care
provider.</text>
</paragraph></subsection><subsection id="H1DAC704FC659439AAB56840471EFAC84"><enum>(c)</enum><header>Enforcement of
certain requirements</header>
<paragraph id="HD4CD5B47F56E4DDCA9BE6ED501D6FB8F"><enum>(1)</enum><header>Complaints</header><text>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
<short-title>Patients’ Bill of Rights Act of
2005</short-title> may file with the Secretary a complaint within 180 days of
the date of the alleged retaliation or discrimination.</text>
</paragraph><paragraph id="H46487B6D06A14ED88EFD689B0010B900"><enum>(2)</enum><header>Investigation</header><text>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.</text>
</paragraph></subsection><subsection id="H64D35039C2FB4545845707CFC41C5E6F"><enum>(d)</enum><header>Conforming
regulations</header><text>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 <short-title>Patients’ Bill of Rights
Act of 2005</short-title> 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.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
<subsection id="H5E6639EB21D64661B5B24C7482F3CDB2"><enum>(b)</enum><header>Satisfaction of
ERISA claims procedure requirement</header><text>Section 503 of such Act (29
U.S.C. 1133) is amended by inserting <quote>(a)</quote> after <quote>Sec.
503.</quote> and by adding at the end the following new subsection:</text>
<quoted-block id="HE1916EA33343410A9CDCADDCC423D29">
<subsection id="H9AA1382D11374C5099EDA6A55B83C7CE"><enum>(b)</enum><text>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 <short-title>Patients’
Bill of Rights Act of 2005</short-title>, 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.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HE1C94B66DFBA4B2CB348CF2EA06D8EAB"><enum>(c)</enum><header>Conforming
amendments</header><paragraph commented="no" display-inline="yes-display-inline" id="H37540BCBA77B488EA4EBA8834200D81E"><enum>(1)</enum><text>Section 732(a) of such
Act (29 U.S.C. 1185(a)) is amended by striking <quote>section 711</quote> and
inserting <quote>sections 711 and 714</quote>.</text>
</paragraph><paragraph id="H4A966F18FFD8461B9518D90085DF48DC" indent="up1"><enum>(2)</enum><text>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:</text>
<quoted-block id="HFF21D989864E4FE8B3872C66574309A8" style="USC">
<toc regeneration="no-regeneration">
<toc-entry level="section">714. Patient protection
standards</toc-entry>
</toc>
<after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H9DCA9844DCA0436C9C1599D9F39DE084" indent="up1"><enum>(3)</enum><text>Section 502(b)(3) of such Act (29
U.S.C. 1132(b)(3)) is amended by inserting <quote>(other than section 135(b) of
the Patients’ Bill of Rights Act of 2005, as deemed by subsection (a) of
section 714 of this Act to be incorporated into such subsection)</quote> after
<quote>part 7</quote>.</text>
</paragraph></subsection></section><section id="H94AA19D80E3A40AA9173EF25D417E7A9"><enum>402.</enum><header>Availability of
civil remedies</header>
<subsection id="HD11DA1A4B0514391A9EB736AA861E5F"><enum>(a)</enum><header>Availability of
Federal civil remedies in cases not involving medically reviewable
decisions</header>
<paragraph id="H0DAD03FEAE814C99A308F8433100CDCD"><enum>(1)</enum><header>In
general</header><text>Section 502 of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name> (29 U.S.C. 1132) is amended by adding at the end the following
new subsections:</text>
<quoted-block act-name="Employee Retirement Income Security Act of 1974" id="HF4E750956F6A426AB5BE333B9F9FC8D">
<subsection id="H8DAA6F194C75488F891D5E28B8DD7910"><enum>(n)</enum><header>Cause of action
relating to provision of health benefits</header>
<paragraph id="HF63AFCBD4F69407794B52DBEA5EC411"><enum>(1)</enum><header>In
general</header><text>In any case in which—</text>
<subparagraph id="HF203501C846D49359B3D80C2CF0095D0"><enum>(A)</enum><text>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, upon consideration of a claim for benefits of a
participant or beneficiary under section 102 of the
<short-title>Patients’ Bill of Rights Act of
2005</short-title> (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—</text>
<clause id="HE04B3320796B48E5A19456E030F68D9B"><enum>(i)</enum><text>regarding whether
an item or service is covered under the terms and conditions of the plan or
coverage,</text>
</clause><clause id="HE659FD32867F463ABE7C8054B0079D6C"><enum>(ii)</enum><text>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</text>
</clause><clause id="HBCEBD0276DFB4F14A2A6A7079700A040"><enum>(iii)</enum><text>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,
and</text>
</clause></subparagraph><subparagraph id="H4D508CDF467A4CC8A30003262127C912"><enum>(B)</enum><text>such failure is a
proximate cause of personal injury to, or the death of, the participant or
beneficiary,</text>
</subparagraph><continuation-text continuation-text-level="paragraph">such plan,
plan sponsor, or issuer 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.</continuation-text></paragraph><paragraph id="H549ED23A0F1842E8AA828FC6E51514DD"><enum>(2)</enum><header>Cause of action
must not involve medically reviewable decision</header>
<subparagraph id="HE0CB8CD6B46A45EDA8EE38E6227EB3B1"><enum>(A)</enum><header>In
general</header><text>A cause of action is established under paragraph (1)(A)
only if the decision referred to in paragraph (1)(A) does not include a
medically reviewable decision.</text>
</subparagraph><subparagraph id="HA98DE757A7A34C61A6CB3C7FE1588C8D"><enum>(B)</enum><header>Medically
reviewable decision</header><text>For purposes of this subsection, the term
<term>medically reviewable decision</term> means a denial of a claim for
benefits under the plan which is described in section 104(d)(2) of the
<short-title>Patients’ Bill of Rights Act of
2005</short-title> (relating to medically reviewable decisions).</text>
</subparagraph></paragraph><paragraph id="HF1C60C692D074F99AE18E3BC49C2EA96"><enum>(3)</enum><header>Limitation
regarding certain types of actions saved from preemption of State
law</header><text>A cause of action is not established under paragraph (1)(A)
in connection with a failure described in paragraph (1)(A) to the extent that a
cause of action under State law (as defined in section 514(c)) for such failure
would not be preempted under section 514.</text>
</paragraph><paragraph id="H3FB289F322CE46058FF0B0C8FE306D4B"><enum>(4)</enum><header>Definitions and
related rules</header><text>For purposes of this subsection.—</text>
<subparagraph id="H97F5994147D94551B732AEED8C39A2AE"><enum>(A)</enum><header>Ordinary
care</header><text>The term <term>ordinary care</term> means, 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 claims
involved.</text>
</subparagraph><subparagraph id="H83B41359A12C4F4FA94F5841BBC382B"><enum>(B)</enum><header>Personal
injury</header><text>The term <term>personal injury</term> means a physical
injury and includes an injury arising out of the treatment (or failure to
treat) a mental illness or disease.</text>
</subparagraph><subparagraph id="H54A8A5916A8A46E4B3BE34FB00FD9CA"><enum>(C)</enum><header>Claim for
benefits; denial</header><text>The terms <term>claim for benefits</term> and
<term>denial of a claim for benefits</term> have the meanings provided such
terms in section 102(e) of the <short-title>Patients’ Bill
of Rights Act of 2005</short-title>.</text>
</subparagraph><subparagraph id="HE033167F8982467192BC4E2230FF87E8"><enum>(D)</enum><header>Terms and
conditions</header><text>The term <term>terms and conditions</term> includes,
with respect to a group health plan or health insurance coverage, requirements
imposed under title I of the <short-title>Patients’ Bill
of Rights Act of 2005</short-title>.</text>
</subparagraph><subparagraph id="H24EC6EACDA9E4165A693D031B6019E78"><enum>(E)</enum><header>Treatment of
excepted benefits</header><text>Under section 154(a) of the
<short-title>Patients’ Bill of Rights Act of
2005</short-title>, the provisions of this subsection and subsection (a)(1)(C)
do not apply to certain excepted benefits.</text>
</subparagraph></paragraph><paragraph id="HD3688137BB4543E30034B0AC552F072F"><enum>(5)</enum><header>Exclusion of
employers and other plan sponsors</header>
<subparagraph id="HAF971DC9718D4223866256C18834064F"><enum>(A)</enum><header>Causes of action
against employers and plan sponsors precluded</header><text>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).</text>
</subparagraph><subparagraph id="H74C3DFB843124EB6987D888060B742B"><enum>(B)</enum><header>Certain causes of
action permitted</header><text>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)
under 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 <short-title>Patients’ Bill of Rights
Act of 2005</short-title> upon consideration of a claim for benefits or under
section 103 of such Act upon review of a denial of a claim for benefits.</text>
</subparagraph><subparagraph id="H830AD27280FB4294B609CB00F8DF5EC7"><enum>(C)</enum><header>Direct
participation</header>
<clause id="HEC32212A01054EE8B66F05B0C8A8C0B0"><enum>(i)</enum><header>In
general</header><text>For purposes of subparagraph (B), the term <term>direct
participation</term> means, in connection with a decision described in
paragraph (1)(A), the actual making of such decision or the actual exercise of
control in making such decision.</text>
</clause><clause id="H489014086BEE4340B9E67D2C9EA69DC2"><enum>(ii)</enum><header>Rules of
construction</header><text>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 paragraph (1)(A) on
a particular claim for benefits of a participant or beneficiary, including (but
not limited to)—</text>
<subclause id="HC58DE32E013043F189E05600EB627A3"><enum>(I)</enum><text>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;</text>
</subclause><subclause id="HDF42305361324E8D987F80DF2D9FA300"><enum>(II)</enum><text>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;</text>
</subclause><subclause id="HC44143D7EC9C4F5A978300888169B441"><enum>(III)</enum><text>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</text>
</subclause><subclause id="H20D225FE039E486B845562C303794F08"><enum>(IV)</enum><text>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.</text>
</subclause></clause><clause id="HBDDF0016776C4C56B7F193B1ED0395D8"><enum>(iii)</enum><header>Irrelevance of
certain collateral efforts made by employer or plan sponsor</header><text>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—</text>
<subclause id="HCD3E79541C044B44BDD1BA1BD7FA801F"><enum>(I)</enum><text>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</text>
</subclause><subclause id="HD5C5B533EE3A4B5DB41EC07CD9D67171"><enum>(II)</enum><text>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).</text>
</subclause></clause></subparagraph><subparagraph id="H40653CA89D3C4960BDDDBAFEB8ADE6ED"><enum>(D)</enum><header>Application to
certain plans</header>
<clause id="H914B42AE4F2E457990EEA72904C91506"><enum>(i)</enum><header>In
general</header><text>Notwithstanding any other provision of this subsection,
no group health plan described in clause (ii) (or plan sponsor of such a plan)
shall be liable under paragraph (1) for the performance of, or the failure to
perform, any non-medically reviewable duty under the plan.</text>
</clause><clause id="HD76A7608EFB142398E49B146064DD0E9"><enum>(ii)</enum><header>Definition</header><text>A
group health plan described in this clause is—</text>
<subclause id="HA2B5E71D4EFB4B5BAEC942EDB2B5F060"><enum>(I)</enum><text>a group health
plan that is self-insured and self administered by an employer (including an
employee of such an employer acting within the scope of employment); or</text>
</subclause><subclause id="H6EFD731D9CCA4AA19D29B2A8B0D48141"><enum>(II)</enum><text>a multiemployer
plan as defined in section 3(37)(A) (including an employee of a contributing
employer or of the plan, or a fiduciary of the plan, acting within the scope of
employment or fiduciary responsibility) that is self-insured and
self-administered.</text>
</subclause></clause></subparagraph></paragraph><paragraph id="HC42CAE7399C64823951D00B87B7FCD03"><enum>(6)</enum><header>Exclusion of
physicians and other health care professionals</header>
<subparagraph id="HC1EF9805CC6F404C8EA115EB021E744D"><enum>(A)</enum><header>In
general</header><text>No treating physician or other treating health care
professional of the participant or beneficiary, and no person acting under the
direction of such a physician or health care professional, shall be liable
under paragraph (1) for the performance of, or the failure to perform, any
non-medically reviewable duty of the plan, the plan sponsor, or any health
insurance issuer offering health insurance coverage in connection with the
plan.</text>
</subparagraph><subparagraph id="HBE57B455E4F747388260F66193F6C61"><enum>(B)</enum><header>Definitions</header><text>For
purposes of subparagraph (A)—</text>
<clause id="HEB35DD63879F4DA80092045387396799"><enum>(i)</enum><header>Health care
professional</header><text>The term <term>health care professional</term> 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.</text>
</clause><clause id="H03C8889CF3BF48770017065C5F5BD800"><enum>(ii)</enum><header>Non-medically
reviewable duty</header><text>The term <term>non-medically reviewable
duty</term> means a duty the discharge of which does not include the making of
a medically reviewable decision.</text>
</clause></subparagraph></paragraph><paragraph id="H5D6FC5BDF49B4CB0AD7984D6526C79F1"><enum>(7)</enum><header>Exclusion of
hospitals</header><text>No treating hospital of the participant or beneficiary
shall be liable under paragraph (1) for the performance of, or the failure to
perform, any non-medically reviewable duty (as defined in paragraph (6)(B)(ii))
of the plan, the plan sponsor, or any health insurance issuer offering health
insurance coverage in connection with the plan.</text>
</paragraph><paragraph id="HF223C40068F745CEA1A900C227EE1EB4"><enum>(8)</enum><header>Rule of
construction relating to exclusion from liability of physicians, health care
professionals, and hospitals</header><text>Nothing in paragraph (6) or (7)
shall be construed to limit the liability (whether direct or vicarious) of the
plan, the plan sponsor, or any health insurance issuer offering health
insurance coverage in connection with the plan.</text>
</paragraph><paragraph id="H37BE296DCA1B4D66B104CE9D60908C88"><enum>(9)</enum><header>Requirement of
exhaustion</header>
<subparagraph id="H42474CD810864161808317D0A85BA5B3"><enum>(A)</enum><header>In
general</header><text>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
<short-title>Patients’ Bill of Rights Act of
2005</short-title> (if applicable) have been exhausted.</text>
</subparagraph><subparagraph id="H2DB793670F534772A2E4EF929FA3A506"><enum>(B)</enum><header>Exception for
needed care</header><text>A participant or beneficiary may seek relief
exclusively in Federal court under subsection 502(a)(1)(B) prior to the
exhaustion of administrative remedies under sections 102, 103, or 104 of the
<short-title>Patients’ Bill of Rights Act of
2005</short-title> (as required under subparagraph (A)) if it is demonstrated
to the court that the exhaustion of such remedies would cause irreparable harm
to the health of the participant or beneficiary. Notwithstanding the awarding
of relief under subsection 502(a)(1)(B) pursuant to this subparagraph, no
relief shall be available as a result of, or arising under, paragraph (1)(A) or
paragraph (10)(B), with respect to a participant or beneficiary, unless the
requirements of subparagraph (A) are met.</text>
</subparagraph><subparagraph id="H7FF50DA1AE9C4BDA00D6ED434F05B2DB"><enum>(C)</enum><header>Receipt of
benefits during appeals process</header><text>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—</text>
<clause id="HA3A9D051C38A494C8D857BD48C622FF7"><enum>(i)</enum><text>shall not preclude
continuation of all such administrative processes to their conclusion if so
moved by any party, and</text>
</clause><clause id="H043F27F5B6334715A0E4E01978636D21"><enum>(ii)</enum><text>shall not
preclude any liability under subsection (a)(1)(C) and this subsection in
connection with such claim.</text>
</clause><continuation-text continuation-text-level="subparagraph">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.</continuation-text></subparagraph><subparagraph id="HE1FC753F41E94612BC0300964C4D0081"><enum>(D)</enum><header>Admissible</header><text>Any
determination made by a reviewer in an administrative proceeding under section
103 of the <short-title>Patients’ Bill of Rights Act of
2005</short-title> shall be admissible in any Federal court proceeding and
shall be presented to the trier of fact.</text>
</subparagraph></paragraph><paragraph id="H050A18A6400F492D9347F67C91407EE1"><enum>(10)</enum><header>Statutory
damages</header>
<subparagraph id="HD373F8B6558547DE93CFF6DC6BB12950"><enum>(A)</enum><header>In
general</header><text>The remedies set forth in this subsection (n) shall be
the exclusive remedies for causes of action brought under this
subsection.</text>
</subparagraph><subparagraph id="H891F3DAB9C6A4513BEC96348678325E9"><enum>(B)</enum><header>Assessment of
civil penalties</header><text>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.</text>
</subparagraph></paragraph><paragraph id="H627E9A1027BB4D10A5D379B6033B009C"><enum>(11)</enum><header>Limitation on
attorneys’ fees</header>
<subparagraph id="H2E1E1EF74DAA4D969DF163001DD9C9D1"><enum>(A)</enum><header>In
general</header><text>Notwithstanding any other provision of law, or any
arrangement, agreement, or contract regarding an attorney’s fee, the amount of
an attorney’s contingency fee allowable for a cause of action brought pursuant
to this subsection shall not exceed <fraction>1/3</fraction> of the total
amount of the plaintiff’s recovery (not including the reimbursement of actual
out-of-pocket expenses of the attorney).</text>
</subparagraph><subparagraph id="H45310A3E15A540678FF31FB3DDC96FA4"><enum>(B)</enum><header>Determination by
district court</header><text>The last Federal district court in which the
action was pending upon the final disposition, including all appeals, of the
action shall have jurisdiction to review the attorney’s fee to ensure that the
fee is a reasonable one.</text>
</subparagraph></paragraph><paragraph id="HDA83084348954615BAB42DF3B435659F"><enum>(12)</enum><header>Limitation of
action</header><text>Paragraph (1) shall not apply in connection with any
action commenced after 3 years after the later of—</text>
<subparagraph id="H0F23B88CC5FD4284A91EC1568E4BE4E0"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="H9748A500C8BB4D51B54BA7CAC8BBDFBB"><enum>(B)</enum><text>the date as of
which the requirements of paragraph (9) are first met.</text>
</subparagraph></paragraph><paragraph id="H9ED8E7779D3F45F0BA3C48F299A29D1F"><enum>(13)</enum><header>Tolling
provision</header><text>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.</text>
</paragraph><paragraph id="H92795498F6E84021A0AB506096543219"><enum>(14)</enum><header>Purchase of
insurance to cover liability</header><text>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.</text>
</paragraph><paragraph id="H6782673E7B964709BA98B022A9F237F7"><enum>(15)</enum><header>Exclusion of
directed recordkeepers</header>
<subparagraph id="H2EC55EBFC02745C3BA9D629B9CAECD06"><enum>(A)</enum><header>In
general</header><text>Subject to subparagraph (C), paragraph (1) shall not
apply with respect to a directed recordkeeper in connection with a group health
plan.</text>
</subparagraph><subparagraph id="HE3897856237E4C03B932312684350000"><enum>(B)</enum><header>Directed
recordkeeper</header><text>For purposes of this paragraph, the term
<term>directed recordkeeper</term> 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
<short-title>Patients’ Bill of Rights Act of
2005</short-title> and whose duties do not include making decisions on claims
for benefits.</text>
</subparagraph><subparagraph id="H64F32958E358495F92EED9FABC4B984F"><enum>(C)</enum><header>Limitation</header><text>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.</text>
</subparagraph></paragraph><paragraph id="H253A253B250042B39230D23B2712D3C4"><enum>(16)</enum><header>Exclusion of
health insurance agents</header><text>Paragraph (1) does not apply with respect
to a person whose sole involvement with the group health plan is providing
advice or administrative services to the employer or other plan sponsor
relating to the selection of health insurance coverage offered in connection
with the plan.</text>
</paragraph><paragraph id="H2AF68F7DACC54B228F8983351C49E8B2"><enum>(17)</enum><header>No effect on
State law</header><text>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.</text>
</paragraph><paragraph id="HA14DCA95527B426E8F1509DA9369EF9"><enum>(18)</enum><header>Relief from
liability for employer or other plan sponsor by means of designated
decisionmaker</header>
<subparagraph id="H3AB9E71741B546208E00EBECC8D1797F"><enum>(A)</enum><header>In
general</header><text>Notwithstanding the direct participation (as defined in
paragraph (5)(C)(i)) of an employer or plan sponsor, in any case in which there
is (or is deemed under subparagraph (B) to be) a designated decisionmaker under
subparagraph (B) that meets the requirements of subsection (o)(1) for an
employer or other plan sponsor—</text>
<clause id="H61D6C1D77705440F93C855F9F3000083"><enum>(i)</enum><text>all liability of
such employer or plan sponsor involved (and any employee of such employer or
sponsor acting within the scope of employment) under this subsection in
connection with any participant or beneficiary shall be transferred to, and
assumed by, the designated decisionmaker, and</text>
</clause><clause id="H41F940BBC4C140F2B659739FAF4FB4F2"><enum>(ii)</enum><text>with respect to
such liability, the designated decisionmaker shall be substituted for the
employer or sponsor (or employee) in the action and may not raise any defense
that the employer or sponsor (or employee) could not raise if such a
decisionmaker were not so deemed.</text>
</clause></subparagraph><subparagraph id="H0F40F92D312F4FCEA49E2951536D5C22"><enum>(B)</enum><header>Automatic
designation</header><text>A health insurance issuer shall be deemed to be a
designated decisionmaker for purposes of subparagraph (A) with respect to the
participants and beneficiaries of an employer or plan sponsor, whether or not
the employer or plan sponsor makes such a designation, and shall be deemed to
have assumed unconditionally all liability of the employer or plan sponsor
under such designation in accordance with subsection (o), unless the employer
or plan sponsor affirmatively enters into a contract to prevent the service of
the designated decisionmaker.</text>
</subparagraph><subparagraph id="H58B01473D06241BAA1DB5AA700FE78"><enum>(C)</enum><header>Treatment of
certain trust funds</header><text>For purposes of this paragraph, the terms
<term>employer</term> and <term>plan sponsor</term>, in connection with the
assumption by a designated decisionmaker of the liability of employer or other
plan sponsor pursuant to this paragraph, shall be construed to include a trust
fund maintained pursuant to section 302 of the Labor Management Relations Act,
1947 (29 U.S.C. 186) or the Railway Labor Act (45 U.S.C. 151 et seq.).</text>
</subparagraph></paragraph><paragraph id="H62A13A226F924DCD86FE31B9524522FC"><enum>(19)</enum><header>Previously
provided services</header>
<subparagraph id="H100B57008C9740529F1F005632AF4D27"><enum>(A)</enum><header>In
general</header><text>Except as provided in this paragraph, a cause of action
shall not arise under paragraph (1) where the denial involved relates to an
item or service that has already been fully provided to the participant or
beneficiary under the plan or coverage and the claim relates solely to the
subsequent denial of payment for the provision of such item or service.</text>
</subparagraph><subparagraph id="H6E2649414DBB4487AD9B997F70E276F6"><enum>(B)</enum><header>Exception</header><text>Nothing
in subparagraph (A) shall be construed to—</text>
<clause id="H8BC8C487933E4CA2A8262014EF8BDF19"><enum>(i)</enum><text>prohibit a cause
of action under paragraph (1) where the nonpayment involved results in the
participant or beneficiary being unable to receive further items or services
that are directly related to the item or service involved in the denial
referred to in subparagraph (A) or that are part of a continuing treatment or
series of procedures; or</text>
</clause><clause id="HB5C75715994B44DB94F8D2846046BCA4"><enum>(ii)</enum><text>limit liability
that otherwise would arise from the provision of the item or services or the
performance of a medical procedure.</text>
</clause></subparagraph></paragraph><paragraph id="HD00EAB0EC86C41F7A8ABE71328474F3"><enum>(20)</enum><header>Exemption from
personal liability for individual members of boards of directors, joint boards
of trustees, etc</header><text>Any individual who is—</text>
<subparagraph id="H43E3B9EA9DED4C51839409B64D26F79"><enum>(A)</enum><text>a member of a board
of directors of an employer or plan sponsor; or</text>
</subparagraph><subparagraph id="H500C111089D049CDBBDB513BFB38FF4C"><enum>(B)</enum><text>a member of an
association, committee, employee organization, joint board of trustees, or
other similar group of representatives of the entities that are the plan
sponsor of plan maintained by two or more employers and one or more employee
organizations;</text>
</subparagraph><continuation-text continuation-text-level="paragraph">shall not
be personally liable under this subsection for conduct that is within the scope
of employment or of plan-related duties of the individuals unless the
individual acts in a fraudulent manner for personal enrichment.</continuation-text></paragraph></subsection><subsection id="H4B7E0908BDBF478BB795C4C08F7D6953"><enum>(o)</enum><header>Requirements for
designated decisionmakers of group health plans</header>
<paragraph id="H5899DCBF3A4046D788EBF5F626873963"><enum>(1)</enum><header>In
general</header><text>For purposes of subsection (n)(18) and section 514(d)(9),
a designated decisionmaker meets the requirements of this paragraph with
respect to any participant or beneficiary if—</text>
<subparagraph id="HABA31C11052647ECAB4E9C8BE473DBB9"><enum>(A)</enum><text>such designation
is in such form as may be prescribed in regulations of the Secretary,</text>
</subparagraph><subparagraph id="H6D1304C1F8B64AC0AD29926530F63B5D"><enum>(B)</enum><text>the designated
decisionmaker—</text>
<clause id="H069B866D924648F5AFF4F0D8769E89F7"><enum>(i)</enum><text>meets the
requirements of paragraph (2),</text>
</clause><clause id="H1196E32F6E7949C987B1C7783EACAFF6"><enum>(ii)</enum><text>assumes
unconditionally all liability of the employer or plan sponsor involved (and any
employee of such employer or sponsor acting within the scope of employment)
either arising under subsection (n) or arising in a cause of action permitted
under section 514(d) in connection with actions (and failures to act) of the
employer or plan sponsor (or employee) occurring during the period in which the
designation under subsection (n)(18) or section 514(d)(9) is in effect relating
to such participant and beneficiary,</text>
</clause><clause id="H67225AABF59A410FA74DE3873915915F"><enum>(iii)</enum><text>agrees to be
substituted for the employer or plan sponsor (or employee) in the action and
not to raise any defense with respect to such liability that the employer or
plan sponsor (or employee) may not raise, and</text>
</clause><clause id="HB91F3B8AFE8B4C73B5E9C4E0F440FCF4"><enum>(iv)</enum><text>where paragraph
(2)(B) applies, assumes unconditionally the exclusive authority under the group
health plan to make medically reviewable decisions under the plan with respect
to such participant or beneficiary, and</text>
</clause></subparagraph><subparagraph id="HC6B98632D3274BFAA2A22C3BE25F02E7"><enum>(C)</enum><text>the designated
decisionmaker and the participants and beneficiaries for whom the decisionmaker
has assumed liability are identified in the written instrument required under
section 402(a) and as required under section 121(b)(19) of the
<short-title>Patients’ Bill of Rights Act of
2005</short-title>.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">Any
liability assumed by a designated decisionmaker pursuant to this subsection
shall be in addition to any liability that it may otherwise have under
applicable law.</continuation-text></paragraph><paragraph id="H5D21B885D2E04F0BA0001B67844E9D3C"><enum>(2)</enum><header>Qualifications
for designated decisionmakers</header>
<subparagraph id="H39337921CF174209B6C9E24C455159D5"><enum>(A)</enum><header>In
general</header><text>Subject to subparagraph (B), an entity is qualified under
this paragraph to serve as a designated decisionmaker with respect to a group
health plan if the entity has the ability to assume the liability described in
paragraph (1) with respect to participants and beneficiaries under such plan,
including requirements relating to the financial obligation for timely
satisfying the assumed liability, and maintains with the plan sponsor and the
Secretary certification of such ability. Such certification shall be provided
to the plan sponsor or named fiduciary and to the Secretary upon designation
under subsection (n)(18)(B) or section 517(d)(9)(B) and not less frequently
than annually thereafter, or if such designation constitutes a multiyear
arrangement, in conjunction with the renewal of the arrangement.</text>
</subparagraph><subparagraph id="HBA4A84EFB1A4418E84D9B33819905BE4"><enum>(B)</enum><header>Special
qualification in the case of certain reviewable decisions</header><text>In the
case of a group health plan that provides benefits consisting of medical care
to a participant or beneficiary only through health insurance coverage offered
by a single health insurance issuer, such issuer is the only entity that may be
qualified under this paragraph to serve as a designated decisionmaker with
respect to such participant or beneficiary, and shall serve as the designated
decisionmaker unless the employer or other plan sponsor acts affirmatively to
prevent such service.</text>
</subparagraph></paragraph><paragraph id="HEE2667AA912D490AA3BA00E2468CDDF7"><enum>(3)</enum><header>Requirements
relating to financial obligations</header><text>For purposes of paragraph
(2)(A), the requirements relating to the financial obligation of an entity for
liability shall include—</text>
<subparagraph id="H350DE2B28F5F4E4D9CF665DA64F0062"><enum>(A)</enum><text>coverage of such
entity under an insurance policy or other arrangement, secured and maintained
by such entity, to effectively insure such entity against losses arising from
professional liability claims, including those arising from its service as a
designated decisionmaker under this part; or</text>
</subparagraph><subparagraph id="H0AD3BA83FCC144B196EA7D3773AA9553"><enum>(B)</enum><text>evidence of
minimum capital and surplus levels that are maintained by such entity to cover
any losses as a result of liability arising from its service as a designated
decisionmaker under this part.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">The
appropriate amounts of liability insurance and minimum capital and surplus
levels for purposes of subparagraphs (A) and (B) shall be determined by an
actuary using sound actuarial principles and accounting practices pursuant to
established guidelines of the American Academy of Actuaries and in accordance
with such regulations as the Secretary may prescribe and shall be maintained
throughout the term for which the designation is in effect. The provisions of
this paragraph shall not apply in the case of a designated decisionmaker that
is a group health plan, plan sponsor, or health insurance issuer and that is
regulated under Federal law or a State financial solvency law.</continuation-text></paragraph><paragraph id="HBB77953B61AF422E983511DEE59DCB9F"><enum>(4)</enum><header>Limitation on
appointment of treating physicians</header><text>A treating physician who
directly delivered the care, treatment, or provided the patient service that is
the subject of a cause of action by a participant or beneficiary under
subsection (n) or section 514(d) may not be designated as a designated
decisionmaker under this subsection with respect to such participant or
beneficiary.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H1CD3B6B5A71D46F3855B88CED0B0A239"><enum>(2)</enum><header>Conforming
amendment</header><text>Section 502(a)(1) of such Act (29 U.S.C. 1132(a)(1)) is
amended—</text>
<subparagraph id="H7DE6206E9F6344AD858DA6FAB401E100"><enum>(A)</enum><text>by striking
<quote>or</quote> at the end of subparagraph (A);</text>
</subparagraph><subparagraph id="H730D521CFB124F3B9FD545CECBF48E6F"><enum>(B)</enum><text>in subparagraph
(B), by striking <quote>plan;</quote> and inserting <quote>plan, or</quote>;
and</text>
</subparagraph><subparagraph id="HB82F88E2621D42D5BF131F00B08997F4"><enum>(C)</enum><text>by adding at the
end the following new subparagraph:</text>
<quoted-block id="H0F7C85B5F163456EB84700276BB74C8F">
<subparagraph id="H3D0812A300CC4C9ABCF6C2BF07A20121"><enum>(C)</enum><text>for the relief
provided for in subsection (n) of this
section.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection><subsection id="HCF03EC1D04BE4F1A8C1151382F34B6E3"><enum>(b)</enum><header>Rules relating
to ERISA preemption</header><text>Section 514 of the
<act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name> (29 U.S.C. 1144) is amended—</text>
<paragraph id="H36C5D53D751949819C3DD72E1EA1E5E1"><enum>(1)</enum><text>by redesignating
subsection (d) as subsection (f); and</text>
</paragraph><paragraph id="H55A1DD4A81104249893D375BD1ADF848"><enum>(2)</enum><text>by inserting after
subsection (c) the following new subsections:</text>
<quoted-block id="HE96CA355CD2C44A99756D536156CA706">
<subsection id="HCB06BCA94F4F4CB3A085E1C37D71BA00"><enum>(d)</enum><header>Preemption not
to apply to causes of action under State law involving medically reviewable
decision</header>
<paragraph id="HE2F53346160844ED9F5257421786EFF"><enum>(1)</enum><header>Non-preemption of
certain causes of action</header>
<subparagraph id="H0A14A7B03AB640F690A3BE5CCCDFD4D"><enum>(A)</enum><header>In
general</header><text>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) against the plan, the plan sponsor, any
health insurance issuer offering health insurance coverage in connection with
the plan, or any managed care entity in connection with the plan to recover
damages resulting from personal injury or for wrongful death if such cause of
action arises by reason of a medically reviewable decision.</text>
</subparagraph><subparagraph id="HDF6DBA0BC8044AB8BC52B59C83B300E"><enum>(B)</enum><header>Medically
reviewable decision</header><text>For purposes of subparagraph (A), the term
<term>medically reviewable decision</term> means a denial of a claim for
benefits under the plan which is described in section 104(d)(2) of the
<short-title>Patients’ Bill of Rights Act of
2005</short-title> (relating to medically reviewable decisions).</text>
</subparagraph><subparagraph id="H7A3B388D2A064DBA8DC667CF8D2095D7"><enum>(C)</enum><header>Limitation on
punitive damages</header>
<clause id="H37515F0C7CEA4ECAB7A7179E91001900"><enum>(i)</enum><header>In
general</header><text>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
<short-title>Patients’ Bill of Rights Act of
2005</short-title> were satisfied with respect to the participant or
beneficiary:</text>
<subclause id="HBA09CB94F5C342A380D6B6C86D00FC86"><enum>(I)</enum><text>Section 102
(relating to procedures for initial claims for benefits and prior authorization
determinations).</text>
</subclause><subclause id="HDC73C6059BE44E6FAEF4DC54A6D860DE"><enum>(II)</enum><text>Section 103 of
such Act (relating to internal appeals of claims denials).</text>
</subclause><subclause id="H9E84FD33159A42139ED078BF123B12CA"><enum>(III)</enum><text>Section 104 of
such Act (relating to independent external appeals procedures).</text>
</subclause></clause><clause id="H5AB06D65D8D145AE90B9ECABB4FB1B9E"><enum>(ii)</enum><header>Exception for
certain actions for wrongful death</header><text>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.</text>
</clause><clause id="H2A532D82570D4DA59F11AD8FF0252FA"><enum>(iii)</enum><header>Exception for
willful or wanton disregard for the rights or safety of
others</header><text>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.</text>
</clause></subparagraph></paragraph><paragraph id="H44DACCE97DAE4A289248FB994618B924"><enum>(2)</enum><header>Definitions and
related rules</header><text>For purposes of this subsection and subsection
(e)—</text>
<subparagraph id="H8B7AFBC218DA44F9A3245DD8E1F2518"><enum>(A)</enum><header>Treatment of
excepted benefits</header><text>Under section 154(a) of the
<short-title>Patients’ Bill of Rights Act of
2005</short-title>, the provisions of this subsection do not apply to certain
excepted benefits.</text>
</subparagraph><subparagraph id="H5F77C97758324D399B8CE942A0FECA75"><enum>(B)</enum><header>Personal
injury</header><text>The term <term>personal injury</term> means a physical
injury and includes an injury arising out of the treatment (or failure to
treat) a mental illness or disease.</text>
</subparagraph><subparagraph id="H76B5061C2B1B48A0BE6BE72EC5B26D00"><enum>(C)</enum><header>Claim for
benefit; denial</header><text>The terms <term>claim for benefits</term> and
<term>denial of a claim for benefits</term> shall have the meaning provided
such terms under section 102(e) of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>.</text>
</subparagraph><subparagraph id="H2CE314E62A22404984C5C76E1791AA75"><enum>(D)</enum><header>Managed care
entity</header>
<clause id="H23D301213C1549AC9CAEBD23BC148007"><enum>(i)</enum><header>In
general</header><text>The term <term>managed care entity</term> means, in
connection with a group health plan and subject to clause (ii), any entity that
is involved in determining the manner in which or the extent to which items or
services (or reimbursement therefor) are to be provided as benefits under the
plan.</text>
</clause><clause id="HDD5F24FF44AE46CEB7D2D5AC05B84C67"><enum>(ii)</enum><header>Treatment of
treating physicians, other treating health care professionals, and treating
hospitals</header><text>Such term does not include a treating physician or
other treating health care professional (as defined in section 502(n)(6)(B)(i))
of the participant or beneficiary and also does not include a treating hospital
insofar as it is acting solely in the capacity of providing treatment or care
to the participant or beneficiary. Nothing in the preceding sentence shall be
construed to preempt vicarious liability of any plan, plan sponsor, health
insurance issuer, or managed care entity.</text>
</clause></subparagraph></paragraph><paragraph id="HC8F61B5468804D0186A593D728BD483C"><enum>(3)</enum><header>Exclusion of
employers and other plan sponsors</header>
<subparagraph id="HDB83B45E6C0C475FAAF3B6D3D04ED75"><enum>(A)</enum><header>Causes of action
against employers and plan sponsors precluded</header><text>Subject to
subparagraph (B), paragraph (1) does not apply with respect to—</text>
<clause id="H42BFD0D1E52A4110823DE20000DACD9D"><enum>(i)</enum><text>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</text>
</clause><clause id="H62F35F80C91043C9BF93A82EE8501561"><enum>(ii)</enum><text>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.</text>
</clause></subparagraph><subparagraph id="H6A6129EA73894AD096E1357EC252FF35"><enum>(B)</enum><header>Certain causes
of action permitted</header><text>Notwithstanding subparagraph (A), paragraph
(1) applies with respect to any cause of action that is brought by 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 employer or other plan sponsor maintaining
the plan (or against an employee of such an employer or sponsor acting within
the scope of employment) if such cause of action arises by reason of a
medically reviewable decision, to the extent that there was direct
participation by the employer or other plan sponsor (or employee) in the
decision.</text>
</subparagraph><subparagraph id="H6E575843CF6E41B8BEA7C503472BFCE"><enum>(C)</enum><header>Direct
participation</header>
<clause id="H9F83DBEFE4D54C49B100C433CDF2ABB7"><enum>(i)</enum><header>Direct
participation in decisions</header><text>For purposes of subparagraph (B), the
term <term>direct participation</term> means, in connection with a decision
described in subparagraph (B), the actual making of such decision or the actual
exercise of control in making such decision or in the conduct constituting the
failure.</text>
</clause><clause id="HC9E4BF3DBFA54C8088491F2455CEDEB4"><enum>(ii)</enum><header>Rules of
construction</header><text>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) on
a particular claim for benefits of a particular participant or beneficiary,
including (but not limited to)—</text>
<subclause id="H3FA79C5229D54F4B9EA39BEE1B6EB677"><enum>(I)</enum><text>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;</text>
</subclause><subclause id="H07564DEEA6E74A438554E384FE363F4C"><enum>(II)</enum><text>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;</text>
</subclause><subclause id="HEEDFA70CAE4045768CEA081172CC84B"><enum>(III)</enum><text>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</text>
</subclause><subclause id="H3024354C15A34486A076379B17B6B9DE"><enum>(IV)</enum><text>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.</text>
</subclause></clause><clause id="HDC5481DC50E446588685D6BAB26C5319"><enum>(iv)</enum><header>Irrelevance of
certain collateral efforts made by employer or plan sponsor</header><text>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—</text>
<subclause id="H87D63500B7A842B3AF8C6E1F54C5C532"><enum>(I)</enum><text>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</text>
</subclause><subclause id="HEF877ECC69BD428C0066111DEF4E0738"><enum>(II)</enum><text>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).</text>
</subclause></clause></subparagraph></paragraph><paragraph id="H794F9D574B9F449B0093EA45AA9BF55B"><enum>(4)</enum><header>Requirement of
exhaustion</header>
<subparagraph id="HCB901AAD71B441E1B7D1E105B7B7FB2"><enum>(A)</enum><header>In
general</header><text>Except as provided in subparagraph (D), paragraph (1)
shall not apply in connection with any action 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 <short-title>Patients’
Bill of Rights Act of 2005</short-title> (if applicable) have been
exhausted.</text>
</subparagraph><subparagraph id="H477C8B629DF24BD98631C958C0CD16E9"><enum>(B)</enum><header>Late
manifestation of injury</header>
<clause id="HC9A06102E2194883BF38303D5633464E"><enum>(i)</enum><header>In
general</header><text>A participant or beneficiary shall not be precluded from
pursuing a review under section 104 of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>
regarding an injury that such participant or beneficiary has experienced if the
external review entity first determines that the injury of such participant or
beneficiary is a late manifestation of an earlier injury.</text>
</clause><clause id="HF570BF77303044858F4F00B5DFD06BDE"><enum>(ii)</enum><header>Definition</header><text>In
this subparagraph, the term <term>late manifestation of an earlier
injury</term> means an injury sustained by the participant or beneficiary which
was not known, and should not have been known, by such participant or
beneficiary by the latest date that the requirements of subparagraph (A) should
have been met regarding the claim for benefits which was denied.</text>
</clause></subparagraph><subparagraph id="H818A51C9B6744712937BC256A3C5485"><enum>(C)</enum><header>Exception for
needed care</header><text>A participant or beneficiary may seek relief
exclusively in Federal court under subsection 502(a)(1)(B) prior to the
exhaustion of administrative remedies under sections 102, 103, or 104 of the
<short-title>Patients’ Bill of Rights Act of
2005</short-title> (as required under subparagraph (A)) if it is demonstrated
to the court that the exhaustion of such remedies would cause irreparable harm
to the health of the participant or beneficiary. Notwithstanding the awarding
of relief under subsection 502(a)(1)(B) pursuant to this subparagraph, no
relief shall be available as a result of, or arising under, paragraph (1)(A)
unless the requirements of subparagraph (A) are met.</text>
</subparagraph><subparagraph id="HF37EC2428FE74BF5BC9DC9D07D6BFA58"><enum>(D)</enum><header>Failure to
review</header>
<clause id="H6D578E9E51964E87A270CC46D4B227F6"><enum>(i)</enum><header>In
general</header><text>If the external review entity fails to make a
determination within the time required under section 104(e)(1)(A)(i) of the
Patients’ Bill of Rights Act of 2005, subparagraph (A) shall not apply with
respect to the action after 10 additional days after the date on which such
time period has expired and the filing of such action shall not affect the duty
of the independent medical reviewer (or reviewers) to make a determination
pursuant to such section 104(e)(1)(A)(i).</text>
</clause><clause id="H04DD76CBD9464ADDBA4E2DDB00EDD440"><enum>(ii)</enum><header>Expedited
determination</header><text display-inline="yes-display-inline">If the external
review entity fails to make a determination within the time required under
section 104(e)(1)(A)(ii) of the Patients’ Bill of Rights Act of 2005,
subparagraph (A) shall not apply with respect to the action and the filing of
such an action shall not affect the duty of the independent medical reviewer
(or reviewers) to make a determination pursuant to such section
104(e)(1)(A)(ii).</text>
</clause></subparagraph><subparagraph id="HE6BE6668516843978BD20358998E2E51"><enum>(E)</enum><header>Receipt of
benefits during appeals process</header><text>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 the
pendency of any action with respect to which, under this paragraph,
subparagraph (A) does not apply—</text>
<clause id="H323B9AE1C3764499AB3E457ECF96C624"><enum>(i)</enum><text>shall not preclude
continuation of all such administrative processes to their conclusion if so
moved by any party, and</text>
</clause><clause id="HFD06F9BA7A3A430483006FDFBCCAE23F"><enum>(ii)</enum><text>shall not
preclude any liability under subsection (a)(1)(C) and this subsection in
connection with such claim.</text>
</clause></subparagraph><subparagraph id="H5D35B0CE72044F5DBB0100423B080877"><enum>(F)</enum><header>Admissible</header><text>Any
determination made by a reviewer in an administrative proceeding under section
104 of the <short-title>Patients’ Bill of Rights Act of
2005</short-title> shall be admissible in any Federal or State court proceeding
and shall be presented to the trier of fact.</text>
</subparagraph></paragraph><paragraph id="H177BC8737E6340E6A5B33307B38797CE"><enum>(5)</enum><header>Tolling
provision</header><text>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.</text>
</paragraph><paragraph id="H21B12C7E69344B0F00EAAD3D82049E95"><enum>(6)</enum><header>Exclusion of
directed recordkeepers</header>
<subparagraph id="H93F6A6BAE640492E8700AE28CD5D9394"><enum>(A)</enum><header>In
general</header><text>Subject to subparagraph (C), paragraph (1) shall not
apply with respect to any action against a directed recordkeeper in connection
with a group health plan.</text>
</subparagraph><subparagraph id="H66C692B2F33647D1A786008C6020FBFF"><enum>(B)</enum><header>Directed
recordkeeper</header><text>For purposes of this paragraph, the term
<term>directed recordkeeper</term> 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
<short-title>Patients’ Bill of Rights Act of
2005</short-title> and whose duties do not include making decisions on claims
for benefits.</text>
</subparagraph><subparagraph id="HD2603BB0CDE247A79E045162CE3853D4"><enum>(C)</enum><header>Limitation</header><text>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.</text>
</subparagraph></paragraph><paragraph id="HCECBA02A50AA43E986CA3C7F27543FAC"><enum>(7)</enum><header>Construction</header><text>Nothing
in this subsection shall be construed as—</text>
<subparagraph id="HAD53F100F7344B2EA2D7E05EEE9507C5"><enum>(A)</enum><text>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—</text>
<clause id="H19203578B545492DA7FB68FEC73DA161"><enum>(i)</enum><text>the application or
interpretation of the exclusion involves a determination described in section
104(d)(2) of the <short-title>Patients’ Bill of Rights Act
of 2005</short-title>, or</text>
</clause><clause id="H0DDC45C8B1264508B6175100EC954498"><enum>(ii)</enum><text>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);</text>
</clause></subparagraph><subparagraph id="HEC7EAF6834DF4A25AAC4172BCD1653D8"><enum>(B)</enum><text>preempting a State
law which requires an affidavit or certificate of merit in a civil
action;</text>
</subparagraph><subparagraph id="H0CDA690E358F4C9880E81FA7CFFC3D16"><enum>(C)</enum><text>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</text>
</subparagraph><subparagraph id="HC0741989BAF84D73B0C81B38232CB25C"><enum>(D)</enum><text>affecting a cause
of action under State law other than a cause of action described in paragraph
(1)(A).</text>
</subparagraph></paragraph><paragraph id="H19DE367626EF440795916784D8AE3D00"><enum>(8)</enum><header>Purchase of
insurance to cover liability</header><text>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).</text>
</paragraph><paragraph id="HAA456F78F2E04FE3B1BABEBB27691FDC"><enum>(9)</enum><header>Relief from
liability for employer or other plan sponsor by means of designated
decisionmaker</header>
<subparagraph id="H84927FF479604997AF72293176AD80D8"><enum>(A)</enum><header>In
general</header><text>Paragraph (1) shall not apply with respect to any cause
of action described in paragraph (1)(A) under State law insofar as such cause
of action provides for liability with respect to a participant or beneficiary
of an employer or plan sponsor (or an employee of such employer or sponsor
acting within the scope of employment), if with respect to the employer or plan
sponsor there is (or is deemed under subparagraph (B) to be) a designated
decisionmaker that meets the requirements of section 502(o)(1) with respect to
such participant or beneficiary. Such paragraph (1) shall apply with respect to
any cause of action described in paragraph (1)(A) under State law against the
designated decisionmaker of such employer or other plan sponsor with respect to
the participant or beneficiary.</text>
</subparagraph><subparagraph id="HCCD70D5E81D54172B1416061762BF28C"><enum>(B)</enum><header>Automatic
designation</header><text>A health insurance issuer shall be deemed to be a
designated decisionmaker for purposes of subparagraph (A) with respect to the
participants and beneficiaries of an employer or plan sponsor, whether or not
the employer or plan sponsor makes such a designation, and shall be deemed to
have assumed unconditionally all liability of the employer or plan sponsor
under such designation in accordance with subsection (o), unless the employer
or plan sponsor affirmatively enters into a contract to prevent the service of
the designated decisionmaker.</text>
</subparagraph><subparagraph id="HB4B25EC69D474993B56EAD79671E3C7"><enum>(C)</enum><header>Treatment of
certain trust funds</header><text>For purposes of this paragraph, the terms
<term>employer</term> and <term>plan sponsor</term>, in connection with the
assumption by a designated decisionmaker of the liability of employer or other
plan sponsor pursuant to this paragraph, shall be construed to include a trust
fund maintained pursuant to section 302 of the Labor Management Relations Act,
1947 (29 U.S.C. 186) or the Railway Labor Act (45 U.S.C. 151 et seq.).</text>
</subparagraph></paragraph><paragraph id="H3F323DBB553C4A62AB8B7B5B716F2990"><enum>(10)</enum><header>Previously
provided services</header>
<subparagraph id="HE8FDD853CF5E40A1A68F863692AB92A4"><enum>(A)</enum><header>In
general</header><text>Except as provided in this paragraph, paragraph (1) shall
not apply with respect to a cause of action where the denial involved relates
to an item or service that has already been fully provided to the participant
or beneficiary under the plan or coverage and the claim relates solely to the
subsequent denial of payment for the provision of such item or service.</text>
</subparagraph><subparagraph id="H685FC8F89E7E46FEAC703564E236C400"><enum>(B)</enum><header>Exception</header><text>Nothing
in subparagraph (A) shall be construed to—</text>
<clause id="HE504A77665254BCEBDC3ACAD3F9CBC46"><enum>(i)</enum><text>exclude a cause of
action from exemption under paragraph (1) where the nonpayment involved results
in the participant or beneficiary being unable to receive further items or
services that are directly related to the item or service involved in the
denial referred to in subparagraph (A) or that are part of a continuing
treatment or series of procedures;</text>
</clause><clause id="H5EF89E2ED3584DFDB882D266235E7058"><enum>(ii)</enum><text display-inline="yes-display-inline">exclude a cause of action from exemption
under paragraph (1) relating to quality of care; or</text>
</clause><clause id="HCC20207497284C119D72BC477E54CF96"><enum>(iii)</enum><text>limit liability
that otherwise would arise from the provision of the item or services or the
performance of a medical procedure.</text>
</clause></subparagraph></paragraph><paragraph id="HE08842C177DD43828300086CF5D89F32"><enum>(11)</enum><header>Exemption from
personal liability for individual members of boards of directors, joint boards
of trustees, etc</header><text>Any individual who is—</text>
<subparagraph id="HEA79D6372E4442ECBFAB29CF30DF1F81"><enum>(A)</enum><text>a member of a
board of directors of an employer or plan sponsor; or</text>
</subparagraph><subparagraph id="H0FDDB158EE9F4AAEBECF49D70731064C"><enum>(B)</enum><text>a member of an
association, committee, employee organization, joint board of trustees, or
other similar group of representatives of the entities that are the plan
sponsor of plan maintained by two or more employers and one or more employee
organizations;</text>
</subparagraph><continuation-text continuation-text-level="paragraph">shall not
be personally liable, by reason of the exemption of a cause of action from
preemption under this subsection, for conduct that is within the scope of
employment or of plan-related duties of the individuals unless the individual
acts in a fraudulent manner for personal enrichment.</continuation-text></paragraph><paragraph id="H2B23815AEAA044D4A8313887F96EAA88"><enum>(12)</enum><header>Choice of
law</header><text>A cause of action exempted from preemption under paragraph
(1) shall be governed by the law (including choice of law rules) of the State
in which the plaintiff resides.</text>
</paragraph><paragraph id="H9DCF5A2EAE7743529CD9068F0000C293"><enum>(13)</enum><header>Limitation on
attorneys’ fees</header>
<subparagraph id="H2C8F687CD6A141E2932270FEEE7500FE"><enum>(A)</enum><header>In
general</header><text>Notwithstanding any other provision of law, or any
arrangement, agreement, or contract regarding an attorney’s fee, the amount of
an attorney’s contingency fee allowable for a cause of action exemption from
preemption under paragraph (1) shall not exceed <fraction>1/3</fraction> of the
total amount of the plaintiff’s recovery (not including the reimbursement of
actual out-of-pocket expenses of the attorney).</text>
</subparagraph><subparagraph id="H56F33F92B9484B8E903F11F4B782B951"><enum>(B)</enum><header>Determination by
court</header><text>The last court in which the action was pending upon the
final disposition, including all appeals, of the action may review the
attorney’s fee to ensure that the fee is a reasonable one.</text>
</subparagraph><subparagraph id="H4443F7EB4ADB41A5BAF17136397EABB0"><enum>(C)</enum><header>No preemption of
State law</header><text>Subparagraph (A) shall not apply with respect to a
cause of action that is brought in a State that has a law or framework of laws
with respect to the amount of an attorney’s contingency fee that may be
incurred for the representation of a participant or beneficiary (or the estate
of such participant or beneficiary) who brings such a cause of action.</text>
</subparagraph></paragraph></subsection><subsection id="H27D3A5CD5693449FB873E5BA342025E"><enum>(e)</enum><header>Rules of
construction relating to health care</header><text>Nothing in this title shall
be construed as—</text>
<paragraph id="HBDB342813F444EEF86CB3303DF3D9199"><enum>(1)</enum><text>affecting any
State law relating to the practice of medicine or the provision of, or the
failure to provide, medical care, or affecting any action (whether the
liability is direct or vicarious) based upon such a State law,</text>
</paragraph><paragraph id="HC7F5CA7F6B7D4745AB61B2D740E6F426"><enum>(2)</enum><text>superseding any
State law permitted under section 152(b)(1)(A) of the
<short-title>Patients’ Bill of Rights Act of
2005</short-title>, or</text>
</paragraph><paragraph id="H0FDD18B1F6454DDC9DB2A0DB1B009B00"><enum>(3)</enum><text>affecting any
applicable State law with respect to limitations on monetary damages.</text>
</paragraph></subsection><subsection id="H29A5611318D7421AB85925F85BC42FE4"><enum>(f)</enum><header>No right of
action for recovery, indemnity, or contribution by issuers against treating
health care professionals and treating hospitals</header><text>In the case of
any care provided, or any treatment decision made, by the treating health care
professional or the treating hospital of a participant or beneficiary under a
group health plan which consists of medical care provided under such plan, any
cause of action under State law against the treating health care professional
or the treating hospital by the plan or a health insurance issuer providing
health insurance coverage in connection with the plan for recovery, indemnity,
or contribution in connection with such care (or any medically reviewable
decision made in connection with such care) or such treatment decision is
superseded.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="HEA40ECB2146345A2AFCC577303DE1CCE"><enum>(c)</enum><header>Effective
date</header><text>The amendments made by this section shall apply to acts and
omissions (from which a cause of action arises) occurring on or after the
applicable effective date under section 601.</text>
</subsection></section><section id="H229B9DDDBF27479BB2AEC6CDC8CE4B83"><enum>403.</enum><header>Cooperation
between Federal and State authorities</header>
<subsection id="H9FFF9B94B17649E399DE4FB8AEF92100"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Subpart C of part 7
of subtitle B of title I of the <act-name parsable-cite="ERISA">Employee
Retirement Income Security Act of 1974</act-name> (29 U.S.C. 1191 et seq.) is
amended by adding at the end the following new section:</text>
<quoted-block act-name="Employee Retirement Income Security Act of 1974" id="HB722603CC9DA4227B3E0F73835ADA345">
<section id="H81B12AA0FADA41F0BF8E59DE38231657"><enum>735.</enum><header>Cooperation
between Federal and State authorities</header>
<subsection id="H29030BA456744AEF8201775DC8FCB600"><enum>(a)</enum><header>Agreement with
States</header><text>A State may enter into an agreement with the Secretary for
the delegation to the State of some or all of the Secretary’s authority under
this title to enforce the requirements applicable under title I of the
<short-title>Patients’ Bill of Rights Act of
2005</short-title> 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.</text>
</subsection><subsection id="HD050674F697142D1A0115500650842DC"><enum>(b)</enum><header>Delegations</header><text>Any
department, agency, or instrumentality of a State to which authority is
delegated pursuant to an agreement entered into under this section may, if
authorized under State law and to the extent consistent with such agreement,
exercise the powers of the Secretary under this title which relate to such
authority.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H8447487BDBB64D95AA490701C1E97D23"><enum>(b)</enum><header>Clerical
amendment</header><text>The table of contents of such Act is amended by
inserting after the item relating to section 734 the following new item:</text>
<quoted-block display-inline="no-display-inline" id="HFEDD666CE8DE4962ACCEBE838DB0F93F" style="OLC">
<toc regeneration="no-regeneration">
<toc-entry level="section">Sec. 735. Cooperation between Federal and
State
authorities</toc-entry>
</toc>
<after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><enum>V</enum><header>Amendments to the
Internal Revenue Code of 1986</header>
<subtitle id="H1D70C16C84DB4021A97DF5B0A52C6C29"><enum>A</enum><header>Application of
patient protection provisions</header>
<section id="HD58BBC4CD33C4B5692957ECBC8B16BA"><enum>501.</enum><header>Application to
group health plans under the Internal Revenue Code of 1986</header><text display-inline="no-display-inline">Subchapter B of chapter 100 of the Internal
Revenue Code of 1986 is amended—</text>
<paragraph id="H355556C602694EFCAED561EDFB7794F1"><enum>(1)</enum><text>in the table of
sections, by inserting after the item relating to section 9812 the following
new item:</text>
<quoted-block display-inline="no-display-inline" id="H6B23C70554B2450E00B5CF37E62D737" style="OLC">
<toc container-level="quoted-block-container" idref="HEA51AE624A7C460FB5F5554286C69D60" lowest-bolded-level="division-lowest-bolded" lowest-level="section" quoted-block="no-quoted-block" regeneration="yes-regeneration">
<toc-entry idref="HFF6103FF2F7048519D248FC3422F277C" level="section">Sec. 9813. Standard relating to patients’ bill of
rights</toc-entry>
</toc>
<after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="H5E42889790DE4222A93EF400C7062BD3"><enum>(2)</enum><text>by inserting after
section 9812 the following:</text>
<quoted-block id="HEA51AE624A7C460FB5F5554286C69D60">
<section id="HFF6103FF2F7048519D248FC3422F277C"><enum>9813.</enum><header>Standard
relating to patients’ bill of rights</header><text display-inline="no-display-inline">A group health plan shall comply with the
requirements of title I of the <short-title>Patients’ Bill
of Rights Act of 2005</short-title> (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.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="H76E8DCC41BF84B97B0C500007BF3533"><enum>502.</enum><header>Conforming
enforcement for women’s health and cancer rights</header><text display-inline="no-display-inline">Subchapter B of chapter 100 of the Internal
Revenue Code of 1986, as amended by section 501, is further amended—</text>
<paragraph id="HA5C86620BEC646B3B4B8713F77A12FAB"><enum>(1)</enum><text>in the table of
sections, by inserting after the item relating to section 9813 the following
new item:</text>
<quoted-block display-inline="no-display-inline" id="HD996DA7BAAB44B3EA35E25A8369BB88" style="OLC">
<toc container-level="quoted-block-container" idref="H336406856233486DA4C81B6C90C6E75C" lowest-bolded-level="division-lowest-bolded" lowest-level="section" quoted-block="no-quoted-block" regeneration="yes-regeneration">
<toc-entry idref="H03A9E37C89AA43438B514B2B6FF20042" level="section">Sec. 9814. Standard relating to women’s health and cancer
rights</toc-entry>
</toc>
<after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="HFE82E12F8CC646BA808F8677FA6ED088"><enum>(2)</enum><text>by inserting after
section 9813 the following:</text>
<quoted-block id="H336406856233486DA4C81B6C90C6E75C">
<section id="H03A9E37C89AA43438B514B2B6FF20042"><enum>9814.</enum><header>Standard
relating to women’s health and cancer rights</header><text display-inline="no-display-inline">The provisions of section 713 of the
<act-name parsable-cite="ERISA">Employee Retirement Income Security Act of
1974</act-name> (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.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section></subtitle><subtitle id="H273738E382854EAF9ED5CDE94AAC800"><enum>B</enum><header>Health care
coverage access tax incentives</header>
<section id="H08A35BC677C542A69E817285A057746B"><enum>511.</enum><header>Credit for
health insurance expenses of small businesses</header>
<subsection id="HC0D95C18C19941F5990057CF5C444DA2"><enum>(a)</enum><header>In
general</header><text>Subpart D of part IV of subchapter A of chapter 1 of the
Internal Revenue Code of 1986 (relating to business-related credits) is amended
by adding at the end the following:</text>
<quoted-block id="HA7F8595AA23F4D6B9C64BCFFBA00F8E6">
<section id="HE6BE77D697A24878B692E282FE35C7B3"><enum>45J.</enum><header>Small business
health insurance expenses</header>
<subsection id="H41DD45E26D8849EB9EE4ECECBD385137"><enum>(a)</enum><header>General
rule</header><text>For purposes of section 38, in the case of a small employer,
the health insurance credit determined under this section for the taxable year
is an amount equal to the applicable percentage of the expenses paid by the
taxpayer during the taxable year for health insurance coverage for such year
provided under a new health plan for employees of such employer.</text>
</subsection><subsection id="H2DB4A856ADF84EFA84DF779D71EB6EFF"><enum>(b)</enum><header>Applicable
percentage</header><text>For purposes of subsection (a), the applicable
percentage is—</text>
<paragraph id="HBCAA2EF5150844FEAD228D82B05B4358"><enum>(1)</enum><text>in the case of
insurance purchased as a member of a qualified health benefit purchasing
coalition (as defined in section 9841), 30 percent, and</text>
</paragraph><paragraph id="H38B527C732C44D768CD1787FBC563EA"><enum>(2)</enum><text>in the case of
insurance not described in paragraph (1), 20 percent.</text>
</paragraph></subsection><subsection id="H45C478D6D5D24C22AF7297009D44ED5E"><enum>(c)</enum><header>Limitations</header>
<paragraph id="H49F3D1E946774A3BAA8582BD472600D8"><enum>(1)</enum><header>Per employee
dollar limitation</header><text>The amount of expenses taken into account under
subsection (a) with respect to any employee for any taxable year shall not
exceed—</text>
<subparagraph id="HCB9E414638D247C0007227CEFA38C9C6"><enum>(A)</enum><text>$2,000 in the case
of self-only coverage, and</text>
</subparagraph><subparagraph id="HA62780C09D63481598A21B085967866B"><enum>(B)</enum><text>$5,000 in the case
of family coverage.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">In the
case of an employee who is covered by a new health plan of the employer for
only a portion of such taxable year, the limitation under the preceding
sentence shall be an amount which bears the same ratio to such limitation
(determined without regard to this sentence) as such portion bears to the
entire taxable year.</continuation-text></paragraph><paragraph id="H3662E42B3D9A440AA7EA04344DED655C"><enum>(2)</enum><header>Period of
coverage</header><text>Expenses may be taken into account under subsection (a)
only with respect to coverage for the 4-year period beginning on the date the
employer establishes a new health plan.</text>
</paragraph></subsection><subsection id="HD7E1EEE9AD5C41BBBA308BBAFD5E3800"><enum>(d)</enum><header>Definitions</header><text>For
purposes of this section—</text>
<paragraph id="HA24FE17B2A7F46E0856D9E6C12C9382E"><enum>(1)</enum><header>Health insurance
coverage</header><text>The term <term>health insurance coverage</term> has the
meaning given such term by section 9832(b)(1).</text>
</paragraph><paragraph id="HB38E339E62534DD290908715FE50CD61"><enum>(2)</enum><header>New health
plan</header>
<subparagraph id="H6B18B06510AC48B49D500953AEF5E1D6"><enum>(A)</enum><header>In
general</header><text>The term <term>new health plan</term> means any
arrangement of the employer which provides health insurance coverage to
employees if—</text>
<clause id="H2F8DBE8D80EB4BF48F974E11745E7874"><enum>(i)</enum><text>such employer (and
any predecessor employer) did not establish or maintain such arrangement (or
any similar arrangement) at any time during the 2 taxable years ending prior to
the taxable year in which the credit under this section is first allowed,
and</text>
</clause><clause id="HBDFEC8E347214FCEB5EE85403FB64B05"><enum>(ii)</enum><text>such arrangement
provides health insurance coverage to at least 70 percent of the qualified
employees of such employer.</text>
</clause></subparagraph><subparagraph id="HDC56927E48284C658496DD0092811EB5"><enum>(B)</enum><header>Qualified
employee</header>
<clause id="H0A45FFC56D20416D85599F08FD3D844E"><enum>(i)</enum><header>In
general</header><text>The term <term>qualified employee</term> means any
employee of an employer if the annual rate of such employee’s compensation (as
defined in section 414(s)) exceeds $10,000.</text>
</clause><clause id="H8872D66C6509403DA471AE10891EA360"><enum>(ii)</enum><header>Treatment of
certain employees</header><text>The term <term>employee</term> shall include a
leased employee within the meaning of section 414(n).</text>
</clause></subparagraph></paragraph><paragraph id="H314B311D97F34F6C86264F29913B52F2"><enum>(3)</enum><header>Small
employer</header><text>The term <term>small employer</term> has the meaning
given to such term by section 4980D(d)(2); except that only qualified employees
shall be taken into account.</text>
</paragraph></subsection><subsection id="H66341A38E2664D89A687480008FEFF6"><enum>(e)</enum><header>Special
rules</header>
<paragraph id="H780A7E2628E74806B50328009C948EF9"><enum>(1)</enum><header>Certain rules
made applicable</header><text>For purposes of this section, rules similar to
the rules of section 52 shall apply.</text>
</paragraph><paragraph id="H2341C575A61C47BBBE1FBF001D1D92D8"><enum>(2)</enum><header>Amounts paid
under salary reduction arrangements</header><text>No amount paid or incurred
pursuant to a salary reduction arrangement shall be taken into account under
subsection (a).</text>
</paragraph></subsection><subsection id="H6CF6E2084B1C4BEAAA31943B07722167"><enum>(f)</enum><header>Termination</header><text>This
section shall not apply to expenses paid or incurred by an employer with
respect to any arrangement established on or after January 1,
2014.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HAF5DFB444A0349CEB43425D0871F1FDA"><enum>(b)</enum><header>Credit to be
part of general business credit</header><text>Section 38(b) of such Code
(relating to current year business credit) is amended by striking
<quote>plus</quote> at the end of paragraph (18), by striking the period at the
end of paragraph (19) and inserting <quote>, plus</quote>, and by adding at the
end the following:</text>
<quoted-block id="H50A6C38112ED4D64BF00D996F668EA54">
<paragraph id="HA23FDDA8D53F49D89EBE55E0F949FEF5"><enum>(20)</enum><text>in the case of a
small employer (as defined in section 45J(d)(3)), the health insurance credit
determined under section
45J(a).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H881D2C1F2A4F406CB75B23C3E2C161FC"><enum>(c)</enum><header>Denial of double
benefit</header><text>Section 280C of such Code is amended by adding at the end
the following new subsection:</text>
<quoted-block id="H0FCE166BCBF647AABA85C77D2B55DA7">
<subsection id="H2C2AB8EE8CDF4501A93E46A0F5FAF518"><enum>(e)</enum><header>Credit for small
business health insurance expenses</header>
<paragraph id="H33957F9F568F4E6D91A08C23C18C00A9"><enum>(1)</enum><header>In
general</header><text>No deduction shall be allowed for that portion of the
expenses (otherwise allowable as a deduction) taken into account in determining
the credit under section 45J for the taxable year which is equal to the amount
of the credit determined for such taxable year under section 45J(a).</text>
</paragraph><paragraph id="H312FF8ECD1FC4475AA113BBF4816D4A8"><enum>(2)</enum><header>Controlled
groups</header><text>Persons treated as a single employer under subsection (a)
or (b) of section 52 shall be treated as 1 person for purposes of this
section.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H6139B0190D8E4DFE9488648D2C7BDF5C"><enum>(d)</enum><header>Clerical
amendment</header><text>The table of sections for subpart D of part IV of
subchapter A of chapter 1 of such Code is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H33C599DA44C74ABAB4B9E60082EF1546" style="OLC">
<toc container-level="quoted-block-container" idref="HA7F8595AA23F4D6B9C64BCFFBA00F8E6" lowest-bolded-level="division-lowest-bolded" lowest-level="section" quoted-block="no-quoted-block" regeneration="yes-regeneration">
<toc-entry idref="HE6BE77D697A24878B692E282FE35C7B3" level="section">Sec. 45J. Small business health insurance
expenses</toc-entry>
</toc>
<after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HB77AA6E79E4B4C6592AD5E0029009C55"><enum>(e)</enum><header>Effective
date</header><text>The amendments made by this section shall apply to amounts
paid or incurred in taxable years beginning after December 31, 2006, for
arrangements established after the date of the enactment of this Act.</text>
</subsection></section><section id="H94321D0C485845F9A30087A3ED62679"><enum>512.</enum><header>Certain grants
by private foundations to qualified health benefit purchasing
coalitions</header>
<subsection id="H057C5AB694DD4ECCA4F288A2D2ED17F"><enum>(a)</enum><header>In
general</header><text>Section 4942 of the Internal Revenue Code of 1986
(relating to taxes on failure to distribute income) is amended by adding at the
end the following:</text>
<quoted-block id="H5742D940FAB14917BFEF8BC8D23C5F3B">
<subsection id="H65C10ED63A5C411E878F33A36351DEC5"><enum>(k)</enum><header>Certain
qualified health benefit purchasing coalition distributions</header>
<paragraph id="H8E6BBE7522F344028647709631D7B4B5"><enum>(1)</enum><header>In
general</header><text>For purposes of subsection (g), sections 170, 501, 507,
509, and 2522, and this chapter, a qualified health benefit purchasing
coalition distribution by a private foundation shall be considered to be a
distribution for a charitable purpose.</text>
</paragraph><paragraph id="HA0C52CC04C0D43028CD23BC9D9B311FA"><enum>(2)</enum><header>Qualified health
benefit purchasing coalition distribution</header><text>For purposes of
paragraph (1)—</text>
<subparagraph id="H9D9F1EF855CF40C89F3F049564DFEF09"><enum>(A)</enum><header>In
general</header><text>The term <term>qualified health benefit purchasing
coalition distribution</term> means any amount paid or incurred by a private
foundation to or on behalf of a qualified health benefit purchasing coalition
(as defined in section 9841) for purposes of payment or reimbursement of
amounts paid or incurred in connection with the establishment and maintenance
of such coalition.</text>
</subparagraph><subparagraph id="HF03FDF3265484EE5B5D42E2905317D45"><enum>(B)</enum><header>Exclusions</header><text>Such
term shall not include any amount used by a qualified health benefit purchasing
coalition (as so defined)—</text>
<clause id="H2593EEE0B5D04AF49C155624DC7239D2"><enum>(i)</enum><text>for the purchase
of real property,</text>
</clause><clause id="HEF236A73E7F74399B76CA45BE4E68346"><enum>(ii)</enum><text>as payment to, or
for the benefit of, members (or employees or affiliates of such members) of
such coalition, or</text>
</clause><clause id="H3F902892EB1A489BB4B55621FE925D7C"><enum>(iii)</enum><text>for any expense
paid or incurred more than 48 months after the date of establishment of such
coalition.</text>
</clause></subparagraph></paragraph><paragraph id="HB9295B65E93D49CF93D8E1352BEDCDC"><enum>(3)</enum><header>Termination</header><text>This
subsection shall not apply—</text>
<subparagraph id="H771B7DBDBCA24C618DB7D212B8BEFA"><enum>(A)</enum><text>to qualified health
benefit purchasing coalition distributions paid or incurred after December 31,
2013, and</text>
</subparagraph><subparagraph id="H861FF64F90544D5685B2AF0087BE73BB"><enum>(B)</enum><text>with respect to
start-up costs of a coalition which are paid or incurred after December 31,
2014.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H582AD39A773C40DEB8CB0473D2E44412"><enum>(b)</enum><header>Qualified health
benefit purchasing coalition</header>
<paragraph id="HA3DD4DEBE1E445D69957BFA86C00F5E8"><enum>(1)</enum><header>In
general</header><text>Chapter 100 of such Code (relating to group health plan
requirements) is amended by adding at the end the following new
subchapter:</text>
<quoted-block id="H4DCDD58B0A564257B1C900F500894CD3">
<subchapter id="H6DB9A87328ED442FADF4D7067500E5ED"><enum>D</enum><header>Qualified health
benefit purchasing coalition</header>
<toc regeneration="no-regeneration">
<toc-entry level="section">Sec. 9841. Qualified health benefit
purchasing coalition</toc-entry>
</toc>
<section id="H6A22DA46A5124C558BD1FA89662021B1"><enum>9841.</enum><header>Qualified
health benefit purchasing coalition</header>
<subsection id="H0E0234B20D7B4C6FA4CE8B78CA92ABDD"><enum>(a)</enum><header>In
general</header><text>A qualified health benefit purchasing coalition is a
private not-for-profit corporation which—</text>
<paragraph id="H65891FC1BAF54D4AAA033D642338AB50"><enum>(1)</enum><text>sells health
insurance through State licensed health insurance issuers in the State in which
the employers to which such coalition is providing insurance are located,
and</text>
</paragraph><paragraph id="HFC72222189B04D7D84F288B578661C6E"><enum>(2)</enum><text>establishes to the
Secretary, under State certification procedures or other procedures as the
Secretary may provide by regulation, that such coalition meets the requirements
of this section.</text>
</paragraph></subsection><subsection id="H0094549A2F6B423C952B197D93B139FE"><enum>(b)</enum><header>Board of
Directors</header>
<paragraph id="HED199BAE9F73400BABA744BE9FBE5109"><enum>(1)</enum><header>In
general</header><text>Each purchasing coalition under this section shall be
governed by a Board of Directors.</text>
</paragraph><paragraph id="H0B0E526E24344E58B5117FF9DE00D4F1"><enum>(2)</enum><header>Election</header><text>The
Secretary shall establish procedures governing election of such Board.</text>
</paragraph><paragraph id="HE72A23B273C340ECBB55CF901754166E"><enum>(3)</enum><header>Membership</header><text>The
Board of Directors shall—</text>
<subparagraph id="H06F6CB7014E94426BF01E14436717EB2"><enum>(A)</enum><text>be composed of
representatives of the members of the coalition, in equal number, including
small employers and employee representatives of such employers, but</text>
</subparagraph><subparagraph id="HAA0A56DB390B4549BC53E9FC7344A7F"><enum>(B)</enum><text>not include other
interested parties, such as service providers, health insurers, or insurance
agents or brokers which may have a conflict of interest with the purposes of
the coalition.</text>
</subparagraph></paragraph></subsection><subsection id="HEF46644A0D224223AEB0BBBB49AB2053"><enum>(c)</enum><header>Membership of
coalition</header>
<paragraph id="HB95C0249407B4B9384005E60BEAA12DA"><enum>(1)</enum><header>In
general</header><text>A purchasing coalition shall accept all small employers
residing within the area served by the coalition as members if such employers
request such membership.</text>
</paragraph><paragraph id="H6FB799D22AFF48B796C38923CA42711"><enum>(2)</enum><header>Other
members</header><text>The coalition, at the discretion of its Board of
Directors, may be open to individuals and large employers.</text>
</paragraph><paragraph id="HC9B2A9FD7EC5409091EAD1ABCE9A12C"><enum>(3)</enum><header>Voting</header><text>Members
of a purchasing coalition shall have voting rights consistent with the rules
established by the State.</text>
</paragraph></subsection><subsection id="H4BB89F1243704CA19DF9B7AC34009200"><enum>(d)</enum><header>Duties of
purchasing coalitions</header><text>Each purchasing coalition shall—</text>
<paragraph id="H546BCFD86F1441D9A3D971E60041E308"><enum>(1)</enum><text>enter into
agreements with small employers (and, at the discretion of its Board, with
individuals and other employers) to provide health insurance benefits to
employees and retirees of such employers,</text>
</paragraph><paragraph id="H4013312154994621BCD547C1C24DE628"><enum>(2)</enum><text>where feasible,
enter into agreements with 3 or more unaffiliated, qualified licensed health
plans, to offer benefits to members,</text>
</paragraph><paragraph id="H70471FC129BB42E0841BB836AC615C30"><enum>(3)</enum><text>offer to members
at least 1 open enrollment period of at least 30 days per calendar year,</text>
</paragraph><paragraph id="H9FD6B726A773404A9BA18A1DA22044C"><enum>(4)</enum><text>serve a significant
geographical area and market to all eligible members in that area, and</text>
</paragraph><paragraph id="H874D5987709D4CCC969000F90039B7E0"><enum>(5)</enum><text>carry out other
functions provided for under this section.</text>
</paragraph></subsection><subsection id="H695E7DB42BDA47808CF04555F11B0434"><enum>(e)</enum><header>Limitation on
activities</header><text>A purchasing coalition shall not—</text>
<paragraph id="H7E7394A051F14A3696A72607BAB83F3B"><enum>(1)</enum><text>perform any
activity (including certification or enforcement) relating to compliance or
licensing of health plans,</text>
</paragraph><paragraph id="H313D8D88B88646FEB2D8837DD26B1B91"><enum>(2)</enum><text>assume insurance
or financial risk in relation to any health plan, or</text>
</paragraph><paragraph id="HC3A60AE135764B54B0876E0545D3A41E"><enum>(3)</enum><text>perform other
activities identified by the State as being inconsistent with the performance
of its duties under this section.</text>
</paragraph></subsection><subsection id="H92167BD22CC54F41B5006D5C721FCA9F"><enum>(f)</enum><header>Additional
requirements for purchasing coalitions</header><text>As provided by the
Secretary in regulations, a purchasing coalition shall be subject to
requirements similar to the requirements of a group health plan under this
chapter.</text>
</subsection><subsection id="HF839B907ABE24FDD94FD5C33BA1FC019"><enum>(g)</enum><header>Relation to
other laws</header>
<paragraph id="H4481BB027D5447EBA704FA184F06F027"><enum>(1)</enum><header>Preemption of
State fictitious group laws</header><text>Requirements (commonly referred to as
fictitious group laws) relating to grouping and similar requirements for health
insurance coverage are preempted to the extent such requirements impede the
establishment and operation of qualified health benefit purchasing
coalitions.</text>
</paragraph><paragraph id="HF49165A9B7704681A425F1868FC100EA"><enum>(2)</enum><header>Allowing savings
to be passed through</header><text>Any State law that prohibits health
insurance issuers from reducing premiums on health insurance coverage sold
through a qualified health benefit purchasing coalition to reflect
administrative savings is preempted. This paragraph shall not be construed to
preempt State laws that impose restrictions on premiums based on health status,
claims history, industry, age, gender, or other underwriting factors.</text>
</paragraph><paragraph id="H72A71F226707487D88CF1119C5EEB3D"><enum>(3)</enum><header>No waiver of
hipaa requirements</header><text>Nothing in this section shall be construed to
change the obligation of health insurance issuers to comply with the
requirements of title XXVII of the <act-name parsable-cite="PHSA">Public Health
Service Act</act-name> with respect to health insurance coverage offered to
small employers in the small group market through a qualified health benefit
purchasing coalition.</text>
</paragraph></subsection><subsection id="H7EA6BC774D364365AA9DC30962BE1200"><enum>(h)</enum><header>Definition of
small employer</header><text>For purposes of this section—</text>
<paragraph id="H1DD6112CEB6542B09BF13019F83EE2EB"><enum>(1)</enum><header>In
general</header><text>The term <term>small employer</term> means, with respect
to any calendar year, any employer if such employer employed an average of at
least 2 and not more than 50 qualified employees on business days during either
of the 2 preceding calendar years. For purposes of the preceding sentence, a
preceding calendar year may be taken into account only if the employer was in
existence throughout such year.</text>
</paragraph><paragraph id="H4B95107BD027493381DF85989021A442"><enum>(2)</enum><header>Employers not in
existence in preceding year</header><text>In the case of an employer which was
not in existence throughout the 1st preceding calendar year, the determination
under paragraph (1) shall be based on the average number of qualified employees
that it is reasonably expected such employer will employ on business days in
the current calendar
year.</text>
</paragraph></subsection></section></subchapter><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="HB2DA524DDB8049C5B357BDA889D7B152"><enum>(2)</enum><header>Conforming
amendment</header><text>The table of subchapters for chapter 100 of such Code
is amended by adding at the end the following item:</text>
<quoted-block display-inline="no-display-inline" id="HFDB002B276C747BD83FFA291C57F4F7E" style="OLC">
<toc regeneration="no-regeneration">
<toc-entry level="subchapter">Subchapter D—Qualified health benefit
purchasing
coalition</toc-entry>
</toc>
<after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="HD50116F1A14A460E8D7BA9CFDF6CA654"><enum>(c)</enum><header>Effective
date</header><text>The amendment made by subsection (a) shall apply to taxable
years beginning after December 31, 2006.</text>
</subsection></section><section id="H79DE5330D1164105887EF0070AB0954"><enum>513.</enum><header>State grant
program for market innovation</header>
<subsection id="H2B0CCF32B35E4ABBB7E832171C7F0854"><enum>(a)</enum><header>In
general</header><text>The Secretary of Health and Human Services (in this
section referred to as the <quote>Secretary</quote>) shall establish a program
(in this section referred to as the <quote>program</quote>) to award
demonstration grants under this section to States to allow States to
demonstrate the effectiveness of innovative ways to increase access to health
insurance through market reforms and other innovative means. Such innovative
means may include (and are not limited to) any of the following:</text>
<paragraph id="H3B629697A5044B38B5609B6771B3C23F"><enum>(1)</enum><text>Alternative group
purchasing or pooling arrangements, such as purchasing cooperatives for small
businesses, reinsurance pools, or high risk pools.</text>
</paragraph><paragraph id="HD770B23F074345EF984EE464D03B0094"><enum>(2)</enum><text>Individual or
small group market reforms.</text>
</paragraph><paragraph id="H5D34A70AC3674A80847CE6A94382D102"><enum>(3)</enum><text>Consumer education
and outreach.</text>
</paragraph><paragraph id="H6CEF5123EAEF4185A5914174771C09D4"><enum>(4)</enum><text>Subsidies to
individuals, employers, or both, in obtaining health insurance.</text>
</paragraph></subsection><subsection id="HE6E0E0DF6BCD4DC3B9C3FBB000952589"><enum>(b)</enum><header>Scope;
duration</header><text>The program shall be limited to not more than 10 States
and to a total period of 5 years, beginning on the date the first demonstration
grant is made.</text>
</subsection><subsection id="H79BE7E57D27946D0A9C4A3DE0849EA00"><enum>(c)</enum><header>Conditions for
demonstration grants</header>
<paragraph id="HFAA5CBD7CEEC4B9DB21F1CEB35611BD3"><enum>(1)</enum><header>In
general</header><text>The Secretary may not provide for a demonstration grant
to a State under the program unless the Secretary finds that under the proposed
demonstration grant—</text>
<subparagraph id="H1471AC48E15145EF8421E4E2BF420742"><enum>(A)</enum><text>the State will
provide for demonstrated increase of access for some portion of the existing
uninsured population through a market innovation (other than merely through a
financial expansion of a program initiated before the date of the enactment of
this Act);</text>
</subparagraph><subparagraph id="H2C0AC76F87B14D13A215707194426FEF"><enum>(B)</enum><text>the State will
comply with applicable Federal laws;</text>
</subparagraph><subparagraph id="H7BCC1242F42C4214865CD5C25928988E"><enum>(C)</enum><text>the State will not
discriminate among participants on the basis of any health status-related
factor (as defined in section 2791(d)(9) of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>), except to the
extent a State wishes to focus on populations that otherwise would not obtain
health insurance because of such factors; and</text>
</subparagraph><subparagraph id="H6A3C1FC052D94343AC67517B20838911"><enum>(D)</enum><text>the State will
provide for such evaluation, in coordination with the evaluation required under
subsection (d), as the Secretary may specify.</text>
</subparagraph></paragraph><paragraph id="H7BB2CAB25E4E4817BA7D14026572ABDA"><enum>(2)</enum><header>Application</header><text>The
Secretary shall not provide a demonstration grant under the program to a State
unless—</text>
<subparagraph id="H36C900B81101498182C39601DE757610"><enum>(A)</enum><text>the State submits
to the Secretary such an application, in such a form and manner, as the
Secretary specifies;</text>
</subparagraph><subparagraph id="H4D8AAAC1842341B880CCD51CB0299C7C"><enum>(B)</enum><text>the application
includes information regarding how the demonstration grant will address issues
such as governance, targeted population, expected cost, and the continuation
after the completion of the demonstration grant period; and</text>
</subparagraph><subparagraph id="H64E6A8DDD1024B41AA58842810FDA19"><enum>(C)</enum><text>the Secretary
determines that the demonstration grant will be used consistent with this
section.</text>
</subparagraph></paragraph><paragraph id="H580788A583F641B4000388A3C8BBE07"><enum>(3)</enum><header>Focus</header><text>A
demonstration grant proposal under section need not cover all uninsured
individuals in a State or all health care benefits with respect to such
individuals.</text>
</paragraph></subsection><subsection id="H6A9E174A70F4443BAAB91133F9E23BEA"><enum>(d)</enum><header>Evaluation</header><text>The
Secretary shall enter into a contract with an appropriate entity outside the
Department of Health and Human Services to conduct an overall evaluation of the
program at the end of the program period. Such evaluation shall include an
analysis of improvements in access, costs, quality of care, or choice of
coverage, under different demonstration grants.</text>
</subsection><subsection id="HABED6FCD5FC049FF9D92DB274DAA1EFA"><enum>(e)</enum><header>Option to
provide for initial planning grants</header><text>Notwithstanding the previous
provisions of this section, under the program the Secretary may provide for a
portion of the amounts appropriated under subsection (f) (not to exceed
$5,000,000) to be made available to any State for initial planning grants to
permit States to develop demonstration grant proposals under the previous
provisions of this section.</text>
</subsection><subsection id="H30CE825A84704B9CACA44A534DEA00"><enum>(f)</enum><header>Authorization of
appropriations</header><text>There are authorized to be appropriated
$100,000,000 for each fiscal year to carry out this section. Amounts
appropriated under this subsection shall remain available until
expended.</text>
</subsection><subsection id="H37B23DC3FB7D4C069141AC485CF9DBE9"><enum>(g)</enum><header>State
defined</header><text>For purposes of this section, the term <term>State</term>
has the meaning given such term for purposes of title XIX of the
<act-name parsable-cite="SSA">Social Security Act</act-name>.</text>
</subsection></section><section id="H16B9E239585F4D5AAFE0C9222EDFF2C7"><enum>514.</enum><header>Grant program
to facilitate health benefits information for small employers</header>
<subsection id="H4AE9EE56ED5746AEB18EC443375F3922"><enum>(a)</enum><header>In
general</header><text>The Small Business Administration shall award grants to 1
or more States, local governments, and non-profit organizations for the
purposes of—</text>
<paragraph id="H90E384D598BC4C0797EE8CE891AA6C7"><enum>(1)</enum><text>demonstrating new
and effective ways to provide information about the benefits of health
insurance to small employers, including tax benefits, increased productivity of
employees, and decreased turnover of employees,</text>
</paragraph><paragraph id="H0D28CBF382D24652857406AC8437F733"><enum>(2)</enum><text>making employers
aware of their current rights in the marketplace under State and Federal health
insurance reforms, and</text>
</paragraph><paragraph id="HE5BD5ADFA6A64299BA29CBA802ED2615"><enum>(3)</enum><text>making employers
aware of the tax treatment of insurance premiums.</text>
</paragraph></subsection><subsection id="H7248EA4064F844218CE0AB00F9D6DF44"><enum>(b)</enum><header>Authorization</header><text>There
is authorized to be appropriated $10,000,000 for each of the first 5 fiscal
years beginning after the date of the enactment of this Act for grants under
subsection (a).</text>
</subsection></section><section id="H7F0573A3A6204783B3F58826C5D46B1"><enum>515.</enum><header>State grant
program for market innovation</header>
<subsection id="H4599D4C83AEA4EDB8026326BFFD9E4D8"><enum>(a)</enum><header>In
general</header><text>The Secretary of Health and Human Services (in this
section referred to as the <quote>Secretary</quote>) shall establish a program
(in this section referred to as the <quote>program</quote>) to award
demonstration grants under this section to States to allow States to
demonstrate the effectiveness of innovative ways to increase access to health
insurance through market reforms and other innovative means. Such innovative
means may include (and are not limited to) any of the following:</text>
<paragraph id="HA40DA1D4ECBC45E5A071A0751F833100"><enum>(1)</enum><text>Alternative group
purchasing or pooling arrangements, such as purchasing cooperatives for small
businesses, reinsurance pools, or high risk pools.</text>
</paragraph><paragraph id="H7B631808969C44FEAD559C20441747AA"><enum>(2)</enum><text>Individual or
small group market reforms.</text>
</paragraph><paragraph id="H2C19476F5F714C579397D9977DF86EB"><enum>(3)</enum><text>Consumer education
and outreach.</text>
</paragraph><paragraph id="HF281D1C2E6E741989391B75D25D18400"><enum>(4)</enum><text>Subsidies to
individuals, employers, or both, in obtaining health insurance.</text>
</paragraph></subsection><subsection id="H06ABE7A8085B49ABB8B5FDE873D34400"><enum>(b)</enum><header>Scope;
duration</header><text>The program shall be limited to not more than 10 States
and to a total period of 5 years, beginning on the date the first demonstration
grant is made.</text>
</subsection><subsection id="H6082A3A9226F4E6B90B600DD8E57BDA0"><enum>(c)</enum><header>Conditions for
demonstration grants</header>
<paragraph id="H495793FB02FE4D4597ED6CB8BBB44CC"><enum>(1)</enum><header>In
general</header><text>The Secretary may not provide for a demonstration grant
to a State under the program unless the Secretary finds that under the proposed
demonstration grant—</text>
<subparagraph id="H703882CD5F274F4A90789570DD3190"><enum>(A)</enum><text>the State will
provide for demonstrated increase of access for some portion of the existing
uninsured population through a market innovation (other than merely through a
financial expansion of a program initiated before the date of the enactment of
this Act);</text>
</subparagraph><subparagraph id="H74FBBA2019024FAAA5B45D2EC8FF65E6"><enum>(B)</enum><text>the State will
comply with applicable Federal laws;</text>
</subparagraph><subparagraph id="H7E242421F73C444EA4A13B92AE4E4709"><enum>(C)</enum><text>the State will not
discriminate among participants on the basis of any health status-related
factor (as defined in section 2791(d)(9) of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>), except to the
extent a State wishes to focus on populations that otherwise would not obtain
health insurance because of such factors; and</text>
</subparagraph><subparagraph id="H3119960661B6407EB6BD26FBAF249D58"><enum>(D)</enum><text>the State will
provide for such evaluation, in coordination with the evaluation required under
subsection (d), as the Secretary may specify.</text>
</subparagraph></paragraph><paragraph id="H43F97A4D8F4D46C990B95543EB2339C2"><enum>(2)</enum><header>Application</header><text>The
Secretary shall not provide a demonstration grant under the program to a State
unless—</text>
<subparagraph id="HCF2B11C7512F4E4DB080706B391D853B"><enum>(A)</enum><text>the State submits
to the Secretary such an application, in such a form and manner, as the
Secretary specifies;</text>
</subparagraph><subparagraph id="H426E16F653E04CCA98B3F2FD75206B00"><enum>(B)</enum><text>the application
includes information regarding how the demonstration grant will address issues
such as governance, targeted population, expected cost, and the continuation
after the completion of the demonstration grant period; and</text>
</subparagraph><subparagraph id="H678F9BDEC8FC4331A98B2C71B516B6D"><enum>(C)</enum><text>the Secretary
determines that the demonstration grant will be used consistent with this
section.</text>
</subparagraph></paragraph><paragraph id="H498BC7DB31824C998D00EB930013C8FD"><enum>(3)</enum><header>Focus</header><text>A
demonstration grant proposal under section need not cover all uninsured
individuals in a State or all health care benefits with respect to such
individuals.</text>
</paragraph></subsection><subsection id="HCB716023C695414790008500BEFC8C00"><enum>(d)</enum><header>Evaluation</header><text>The
Secretary shall enter into a contract with an appropriate entity outside the
Department of Health and Human Services to conduct an overall evaluation of the
program at the end of the program period. Such evaluation shall include an
analysis of improvements in access, costs, quality of care, or choice of
coverage, under different demonstration grants.</text>
</subsection><subsection id="H353FCA7194E34430A07B04E15403658F"><enum>(e)</enum><header>Option to
provide for initial planning grants</header><text>Notwithstanding the previous
provisions of this section, under the program the Secretary may provide for a
portion of the amounts appropriated under subsection (f) (not to exceed
$5,000,000) to be made available to any State for initial planning grants to
permit States to develop demonstration grant proposals under the previous
provisions of this section.</text>
</subsection><subsection id="H28050D8414C2420384F2F6FBD1F1AFC4"><enum>(f)</enum><header>Authorization of
appropriations</header><text>There are authorized to be appropriated
$100,000,000 for each fiscal year to carry out this section. Amounts
appropriated under this subsection shall remain available until
expended.</text>
</subsection><subsection id="HDFF3514F369C455EB76210C754FD79"><enum>(g)</enum><header>State
defined</header><text>For purposes of this section, the term <term>State</term>
has the meaning given such term for purposes of title XIX of the
<act-name parsable-cite="SSA">Social Security Act</act-name>.</text>
</subsection></section></subtitle><enum>VI</enum><header>Effective dates;
coordination in implementation</header>
<section id="HED6BD84EC3D24B0790C13C699E6BB4E"><enum>601.</enum><header>Effective
dates</header>
<subsection id="H3668494D0A9E4F49BD25B6A299BA364C"><enum>(a)</enum><header>Group health
coverage</header>
<paragraph id="H1F652302CA574F3D85B31EE8C3EA1203"><enum>(1)</enum><header>In
general</header><text>Subject to paragraph (2) and subsection (d), the
amendments made by sections 201(a), 401, 501, and 502 (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 October 1, 2006 (in this section referred
to as the <quote>general effective date</quote>).</text>
</paragraph><paragraph id="H3628075779F64243AA3F12E19F9D5F19"><enum>(2)</enum><header>Treatment of
collective bargaining agreements</header><text>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), 401,
501, and 502 (and title I insofar as it relates to such sections) shall not
apply to plan years beginning before the later of—</text>
<subparagraph id="H57CBAE6B92144CF3BEFE427F00C8582"><enum>(A)</enum><text>the date on which
the last collective bargaining agreements relating to the plan terminates
(excluding any extension thereof agreed to after the date of the enactment of
this Act); or</text>
</subparagraph><subparagraph id="H71C3DFB394A44B15B8FD000976D3C8B"><enum>(B)</enum><text>the general
effective date;</text>
</subparagraph><continuation-text continuation-text-level="paragraph">but shall
apply not later than 1 year after the general effective date. For purposes of
subparagraph (A), any plan amendment made pursuant to a collective bargaining
agreement relating to the plan which amends the plan solely to conform to any
requirement added by this Act shall not be treated as a termination of such
collective bargaining agreement.</continuation-text></paragraph></subsection><subsection id="HD6489573638A450AB7890417757B127D"><enum>(b)</enum><header>Individual
health insurance coverage</header><text>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.</text>
</subsection><subsection id="H137CDE24D4944996ACE3129D675B104D"><enum>(c)</enum><header>Treatment of
religious nonmedical providers</header>
<paragraph id="H3A0B9E8351B54204B6DB27F2727EE7C0"><enum>(1)</enum><header>In
general</header><text>Nothing in this Act (or the amendments made thereby)
shall be construed to—</text>
<subparagraph id="H0343C66B608447D89E4C4D3B862532AE"><enum>(A)</enum><text>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;</text>
</subparagraph><subparagraph id="HE370EB7BFA874F02B8AA70E8DCD3EFF7"><enum>(B)</enum><text>require such plans
or issuers to—</text>
<clause id="H2FD2FD55DC29424DA44CF56B96BDFEB6"><enum>(i)</enum><text>utilize medically
based eligibility standards or criteria in deciding provider status of
religious nonmedical providers;</text>
</clause><clause id="H0C5AFD8D502B470F9D0054506EB018F5"><enum>(ii)</enum><text>use
medical professionals or criteria to decide patient access to religious
nonmedical providers;</text>
</clause><clause id="H3377D79383124C65A14F966E24E58BFE"><enum>(iii)</enum><text>utilize medical
professionals or criteria in making decisions in internal or external appeals
regarding coverage for care by religious nonmedical providers; or</text>
</clause><clause id="HB73E0A35FF0E44C1B2302B3FEE91693F"><enum>(iv)</enum><text>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</text>
</clause></subparagraph><subparagraph id="HCE12F40DDB0F48B9B60041EEFDC7E0DE"><enum>(C)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="HE4D14C10199A468FBA814970AA91BFBB"><enum>(2)</enum><header>Religious
nonmedical provider</header><text>For purposes of this subsection, the term
<term>religious nonmedical provider</term> means a provider who provides no
medical care but who provides only religious nonmedical treatment or religious
nonmedical nursing care.</text>
</paragraph></subsection><subsection id="HCA2373FC12364F2598191E58AD3DE7FC"><enum>(d)</enum><header>Transition for
notice requirement</header><text>The disclosure of information required under
section 121 of this Act shall first be provided pursuant to—</text>
<paragraph id="H92938C91FA484B8DBD00ECC2577E113"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="HD04563246F38469B99E86BF026762681"><enum>(2)</enum><text>subsection (b)
with respect to an 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.</text>
</paragraph></subsection></section><section id="H634FFBE3A53842679BEBB30016675B75"><enum>602.</enum><header>Coordination in
implementation</header><text display-inline="no-display-inline">The Secretary
of Labor and the Secretary of Health and Human Services shall ensure, through
the execution of an interagency memorandum of understanding among such
Secretaries, that—</text>
<paragraph id="HA5995FE9361240C98693DF002EE182A9"><enum>(1)</enum><text>regulations,
rulings, and interpretations issued by such Secretaries relating to the same
matter over which such Secretaries have responsibility under the provisions of
this Act (and the amendments made thereby) are administered so as to have the
same effect at all times; and</text>
</paragraph><paragraph id="HB6521F644793407D90E4A4E25E8FE58B"><enum>(2)</enum><text>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.</text>
</paragraph></section><section id="H719D848956284762AB2359EDB4FC9B00"><enum>603.</enum><header>Severability</header><text display-inline="no-display-inline">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.</text>
</section><enum>VII</enum><header>Miscellaneous
provisions</header>
<section id="HEDE49D65BEC347A693A9E4E42EFBEFD"><enum>701.</enum><header>No impact on
Social Security Trust Fund</header>
<subsection id="H9C6920D1EAFC4F35B4454CB29CF4B1BC"><enum>(a)</enum><header>In
general</header><text>Nothing in this Act (or an amendment made by this Act)
shall be construed to alter or amend the <act-name parsable-cite="SSA">Social
Security Act</act-name> (or any regulation promulgated under that Act).</text>
</subsection><subsection id="H6F60D648E9CD46D2A051EC67ADDDB74"><enum>(b)</enum><header>Transfers</header>
<paragraph id="HFB51BBF243F24DCA8352ECFB475EF8E"><enum>(1)</enum><header>Estimate of
Secretary</header><text>The Secretary of the Treasury shall annually estimate
the impact that the enactment of this Act has on the income and balances of the
trust funds established under section 201 of the <act-name parsable-cite="SSA">Social Security Act</act-name> (42 U.S.C. 401).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4A66BA4719344DBCA9797EF914BD07F"><enum>(2)</enum><header>Transfer of
funds</header><text>If, under paragraph (1), the Secretary of the Treasury
estimates that the enactment of this Act has a negative impact on the income
and balances of the trust funds established under section 201 of the
<act-name parsable-cite="SSA">Social Security Act</act-name> (42 U.S.C. 401),
the Secretary shall transfer, not less frequently than quarterly, from the
general revenues of the Federal Government an amount sufficient so as to ensure
that the income and balances of such trust funds are not reduced as a result of
the enactment of such Act.</text>
</paragraph></subsection></section>