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quest that informational materials be provided in
printed form.
‘‘(f) CONFORMING REGULATIONS.—The Secretary shall
issue regulations to coordinate the requirements on group
health plans and health insurance issuers under this section
with the requirements imposed under part 1, to reduce du-
plication with respect to any information that is required
to be provided under any such requirements.
‘‘(g) SECRETARIAL ENFORCEMENT AUTHORITY.—
‘‘(1) IN GENERAL.—The Secretary may assess a
civil monetary penalty against the administrator of
a plan or issuer in connection with the failure of the
plan or issuer to comply with the requirements of this
section.
‘‘(2) AMOUNT OF PENALTY.—
‘‘(A) IN GENERAL.—The amount of the pen-
alty to be imposed under paragraph (1) shall not
exceed $100 for each day for each participant
and beneficiary with respect to which the failure
to comply with the requirements of this section
occurs.
‘‘(B) INCREASE IN AMOUNT.—The amount
referred to in subparagraph (A) shall be in-
creased or decreased, for each calendar year that
ends after December 31, 2000, by the same per-
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centage as the percentage by which the medical
care expenditure category of the Consumer Price
Index for All Urban Consumers (United States
city average), published by the Bureau of Labor
Statistics, for September of the preceding cal-
endar year has increased or decreased from the
such Index for September of 2000.
‘‘(3) FAILURE DEFINED.—For purposes of this
subsection, a plan or issuer shall have failed to com-
ply with the requirements of this section with respect
to a participant or beneficiary if the plan or issuer
failed or refused to comply with the requirements of
this section within 30 days—
‘‘(A) of the date described in subsection
(a)(1)(A)(i);
‘‘(B) of the date described in subsection
(a)(1)(A)(ii); or
‘‘(C) of the date on which additional infor-
mation was requested under subsection (c).’’.
(b) CONFORMING AMENDMENTS.—
(1) Section 732(a) of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1191a(a)) is
amended by striking ‘‘section 711’’ and inserting
‘‘sections 711 and 714’’.
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(2) The table of contents in section 1 of the Em-
ployee Retirement Income Security Act of 1974 (29
U.S.C. 1001) is amended by inserting after the item
relating to section 713, the following:
‘‘Sec 714. Health plan comparative information.’’.
(3) Section 502(b)(3) of the Employee Retire-
ment Income Security Act of 1974 (29 U.S.C.
1132(b)(3)) is amended by striking ‘‘733(a)(1))’’ and
inserting ‘‘733(a)(1)), except with respect to the re-
quirements of section 714’’.
SEC. 2212. INFORMATION ABOUT PROVIDERS.
(a) STUDY.—The Secretary of Health and Human
Services shall enter into a contract with the Institute of
Medicine for the conduct of a study, and the submission
to the Secretary of a report, that includes—
(1) an analysis of information concerning health
care professionals that is currently available to pa-
tients, consumers, States, and professional societies,
nationally and on a State-by-State basis, including
patient preferences with respect to information about
such professionals and their competencies;
(2) an evaluation of the legal and other barriers
to the sharing of information concerning health care
professionals; and
(3) recommendations for the disclosure of infor-
mation on health care professionals, including the
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competencies and professional qualifications of such
practitioners, to better facilitate patient choice, qual-
ity improvement, and market competition.
(b) REPORT.—Not later than 18 months after the date
of enactment of this Act, the Secretary of Health and
Human Services shall forward to the appropriate commit-
tees of Congress a copy of the report and study conducted
under subsection (a).
Subtitle C—Right to Hold Health
Plans Accountable
SEC. 2221. AMENDMENTS TO EMPLOYEE RETIREMENT IN-
COME SECURITY ACT OF 1974.
(a) IN GENERAL.—Part 5 of subtitle B of title I of
the Employee Retirement Income Security Act of 1974 is
amended by inserting after section 503 (29 U.S.C. 1133)
the following:
‘‘SEC. 503A. CLAIMS AND INTERNAL APPEALS PROCEDURES
FOR GROUP HEALTH PLANS.
‘‘(a) INITIAL CLAIM FOR BENEFITS UNDER GROUP
HEALTH PLANS.—
‘‘(1) PROCEDURES.—
‘‘(A) IN GENERAL.—A group health plan, or
health insurance issuer offering health insurance
coverage in connection with a group health plan,
shall ensure that procedures are in place for—
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‘‘(i) making a determination on an
initial claim for benefits by a participant
or beneficiary (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 partici-
pant or beneficiary is required to pay with
respect to such claim for benefits; and
‘‘(ii) notifying a participant or bene-
ficiary (or authorized representative) and
the treating health care professional in-
volved regarding a determination on an ini-
tial claim for benefits made under the terms
and conditions of the plan or coverage, in-
cluding any cost-sharing amounts that the
participant or beneficiary may be required
to make with respect to such claim for bene-
fits, and of the right of the participant or
beneficiary to an internal appeal under
subsection (b).
‘‘(B) ACCESS TO INFORMATION.—With re-
spect to an initial claim for benefits, the partici-
pant or beneficiary (or authorized representa-
tive) and the treating health care professional (if
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any) shall provide the plan or issuer with access
to information necessary to make a determina-
tion relating to the claim, not later than 5 busi-
ness days after the date on which the claim is
filed or to meet the applicable timelines under
clauses (ii) and (iii) of paragraph (2)(A).
‘‘(C) ORAL REQUESTS.—In the case of a
claim for benefits involving an expedited or con-
current determination, a participant or bene-
ficiary (or authorized representative) may make
an initial claim for benefits orally, but a group
health plan, or health insurance issuer offering
health insurance coverage in connection with a
group health plan, may require that the partici-
pant or beneficiary (or authorized representa-
tive) provide written confirmation of such re-
quest in a timely manner.
‘‘(2) TIMELINE FOR MAKING DETERMINATIONS.—
‘‘(A) PRIOR
AUTHORIZATION
DETERMINA-
TION.—
‘‘(i) IN
GENERAL.—A group health
plan, or health insurance issuer offering
health insurance coverage in connection
with a group health plan, shall maintain
procedures to ensure that a prior authoriza-
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tion determination on a claim for benefits
is made within 14 business days from the
date on which the plan or issuer receives in-
formation that is reasonably necessary to
enable the plan or issuer to make a deter-
mination on the request for prior authoriza-
tion, but in no case shall such determina-
tion be made later than 28 business days
after the receipt of the claim for benefits.
‘‘(ii) EXPEDITED
DETERMINATION.—
Notwithstanding clause (i), a group health
plan, or health insurance issuer offering
health insurance coverage in connection
with a group health plan, shall maintain
procedures for expediting a prior authoriza-
tion determination on a claim for benefits
described in such clause when a request for
such an expedited determination is made by
a participant or beneficiary (or authorized
representative) at any time during the proc-
ess for making a determination and the
treating health care professional substan-
tiates, with the request, that a determina-
tion under the procedures described in
clause (i) would seriously jeopardize the life
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or health of the participant or beneficiary.
Such determination shall be made within
72 hours after a request is received by the
plan or issuer under this clause.
‘‘(iii) 
CONCURRENT
DETERMINA-
TIONS.—A group health plan, or health in-
surance issuer offering health insurance cov-
erage in connection with a group health
plan, shall maintain procedures to ensure
that a concurrent determination on a claim
for benefits that results in a discontinuation
of inpatient care is made within 24 hours
after the receipt of the claim for benefits.
‘‘(B) RETROSPECTIVE DETERMINATION.—A
group health plan, or health insurance issuer of-
fering health insurance coverage in connection
with a group health plan, shall maintain proce-
dures to ensure that a retrospective determina-
tion on a claim for benefits is made within 30
business days of 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, but in no case shall
such determination be made later than 60 busi-
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ness days after the receipt of the claim for bene-
fits.
‘‘(3) NOTICE OF A DENIAL OF A CLAIM FOR BEN-
EFITS.—Written notice of a denial made under an
initial claim for benefits shall be issued to the partici-
pant or beneficiary (or authorized representative) and
the treating health care professional not later than 2
business days after the determination (or within the
72-hour or 24-hour period referred to in clauses (ii)
and (iii) of paragraph (2)(A) if applicable).
‘‘(4) REQUIREMENTS OF NOTICE OF DETERMINA-
TIONS.—The written notice of a denial of a claim for
benefits determination under paragraph (3) shall
include—
‘‘(A) the reasons for the determination (in-
cluding a summary of the clinical or scientific-
evidence based rationale used in making the de-
termination and instruction on obtaining a
more complete description written in a manner
calculated to be understood by the average par-
ticipant);
‘‘(B) the procedures for obtaining addi-
tional information concerning the determination;
and
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‘‘(C) notification of the right to appeal the
determination and instructions on how to ini-
tiate an appeal in accordance with subsection
(b).
‘‘(b) INTERNAL APPEAL OF A DENIAL OF A CLAIM FOR
BENEFITS.—
‘‘(1) RIGHT TO INTERNAL APPEAL.—
‘‘(A) IN GENERAL.—A participant or bene-
ficiary (or authorized representative) may ap-
peal any denial of a claim for benefits under
subsection (a) under the procedures described in
this subsection.
‘‘(B) TIME FOR APPEAL.—A group health
plan, or health insurance issuer offering health
insurance coverage in connection with a group
health plan, shall ensure that a participant or
beneficiary (or authorized representative) has a
period of not less than 60 days beginning on the
date of a denial of a claim for benefits under
subsection (a) in which to appeal such denial
under this subsection.
‘‘(C) FAILURE TO ACT.—The failure of a
plan or issuer to issue a determination on a
claim for benefits under subsection (a) within the
applicable timeline established for such a deter-
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mination under such subsection shall be treated
as a denial of a claim for benefits for purposes
of proceeding to internal review under this sub-
section.
‘‘(D) PLAN
WAIVER
OF
INTERNAL
RE-
VIEW.—A group health plan, or health insurance
issuer offering health insurance coverage in con-
nection with a group health plan, may waive the
internal review process under this subsection and
permit a participant or beneficiary (or author-
ized representative) to proceed directly to exter-
nal review under section 503B.
‘‘(2) 
TIMELINES
FOR
MAKING
DETERMINA-
TIONS.—
‘‘(A) ORAL REQUESTS.—In the case of an
appeal of a denial of a claim for benefits under
this subsection that involves an expedited or con-
current determination, a participant or bene-
ficiary (or authorized representative) may re-
quest such appeal orally, but a group health
plan, or health insurance issuer offering health
insurance coverage in connection with a group
health plan, may require that the participant or
beneficiary (or authorized representative) pro-
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vide written confirmation of such request in a
timely manner.
‘‘(B) ACCESS TO INFORMATION.—With re-
spect to an appeal of a denial of a claim for ben-
efits, the participant or beneficiary (or author-
ized representative) and the treating health care
professional (if any) shall provide the plan or
issuer with access to information necessary to
make a determination relating to the appeal, not
later than 5 business days after the date on
which the request for the appeal is filed or to
meet the applicable timelines under clauses (ii)
and (iii) of subparagraph (C).
‘‘(C) PRIOR
AUTHORIZATION
DETERMINA-
TIONS.—
‘‘(i) IN
GENERAL.—A group health
plan, or health insurance issuer offering
health insurance coverage in connection
with a group health plan, shall maintain
procedures to ensure that a determination
on an appeal of a denial of a claim for ben-
efits under this subsection is made within
14 business days after the date on which the
plan or issuer receives information that is
reasonably necessary to enable the plan or
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issuer to make a determination on the ap-
peal, but in no case shall such determina-
tion be made later than 28 business days
after the receipt of the request for the ap-
peal.
‘‘(ii) EXPEDITED
DETERMINATION.—
Notwithstanding clause (i), a group health
plan, or health insurance issuer offering
health insurance coverage in connection
with a group health plan, shall maintain
procedures for expediting a prior authoriza-
tion determination on an appeal of a denial
of a claim for benefits described in clause
(i), when a request for such an expedited de-
termination is made by a participant or
beneficiary (or authorized representative) at
any time during the process for making a
determination and the treating health care
professional substantiates, with the request,
that a determination under the procedures
described in clause (i) would seriously jeop-
ardize the life or health of the participant
or beneficiary. Such determination shall be
made not later than 72 hours after the re-
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quest for such appeal is received by the plan
or issuer under this clause.
‘‘(iii) 
CONCURRENT
DETERMINA-
TIONS.—A group health plan, or health in-
surance issuer offering health insurance cov-
erage in connection with a group health
plan, shall maintain procedures to ensure
that a concurrent determination on an ap-
peal of a denial of a claim for benefits that
results in a discontinuation of inpatient
care is made within 24 hours after the re-
ceipt of the request for appeal.
‘‘(B) RETROSPECTIVE DETERMINATION.—A
group health plan, or health insurance issuer of-
fering health insurance coverage in connection
with a group health plan, shall maintain proce-
dures to ensure that a retrospective determina-
tion on an appeal of a claim for benefits is made
within 30 business days of the date on which the
plan or issuer receives necessary information
that is reasonably required by the plan or issuer
to make a determination on the appeal, but in
no case shall such determination be made later
than 60 business days after the receipt of the re-
quest for the appeal.
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‘‘(3) CONDUCT OF REVIEW.—
‘‘(A) IN GENERAL.—A review of a denial of
a claim for benefits under this subsection shall be
conducted by an individual with appropriate ex-
pertise who was not directly involved in the ini-
tial determination.
‘‘(B) REVIEW OF MEDICAL DECISIONS BY
PHYSICIANS.—A review of an appeal of a denial
of a claim for benefits that is based on a lack of
medical necessity and appropriateness, or based
on an experimental or investigational treatment,
or requires an evaluation of medical facts, shall
be made by a physician with appropriate exper-
tise, including age-appropriate expertise, who
was not involved in the initial determination.
‘‘(4) NOTICE OF DETERMINATION.—
‘‘(A) IN GENERAL.—Written notice of a de-
termination made under an internal appeal of a
denial of a claim for benefits shall be issued to
the participant or beneficiary (or authorized rep-
resentative) and the treating health care profes-
sional not later than 2 business days after the
completion of the review (or within the 72-hour
or 24-hour period referred to in paragraph (2)
if applicable).
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‘‘(B) FINAL DETERMINATION.—The decision
by a plan or issuer under this subsection 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 determina-
tion on an appeal of a denial of a claim for ben-
efits under this subsection 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 503B.
‘‘(C) REQUIREMENTS OF NOTICE.—With re-
spect to a determination made under this sub-
section, the notice described in subparagraph (A)
shall include—
‘‘(i) the reasons for the determination
(including a summary of the clinical or sci-
entific-evidence based rationale used in
making the determination and instruction
on obtaining a more complete description
written in a manner calculated to be under-
stood by the average participant);
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‘‘(ii) the procedures for obtaining addi-
tional information concerning the deter-
mination; and
‘‘(iii) notification of the right to an
independent external review under section
503B and instructions on how to initiate
such a review.
‘‘(c) DEFINITIONS.—The definitions contained in sec-
tion 503B(i) shall apply for purposes of this section.
‘‘SEC. 503B. INDEPENDENT EXTERNAL APPEALS PROCE-
DURES FOR GROUP HEALTH PLANS.
‘‘(a) RIGHT TO EXTERNAL APPEAL.—A group health
plan, and a health insurance issuer offering health insur-
ance coverage in connection with a group health plan, shall
provide in accordance with this section participants and
beneficiaries (or authorized representatives) with access to
an independent external review for any denial of a claim
for benefits.
‘‘(b) INITIATION
OF
THE INDEPENDENT EXTERNAL
REVIEW PROCESS.—
‘‘(1) TIME
TO
FILE.—A request for an inde-
pendent external review under this section shall be
filed with the plan or issuer not later than 60 busi-
ness days after the date on which the participant or
beneficiary receives notice of the denial under section
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503A(b)(4) or the date on which the internal review
is waived by the plan or issuer under section
503A(b)(1)(D).
‘‘(2) FILING OF REQUEST.—
‘‘(A) IN
GENERAL.—Subject to the suc-
ceeding provisions of this subsection, a group
health plan, and a health insurance issuer offer-
ing health insurance coverage in connection with
a group health plan, may—
‘‘(i) except as provided in subpara-
graph (B)(i), require that a request for re-
view be in writing;
‘‘(ii) limit the filing of such a request
to the participant or beneficiary involved
(or an authorized representative);
‘‘(iii) except if waived by the plan or
issuer under section 503A(b)(1)(D), condi-
tion access to an independent external re-
view under this section upon a final deter-
mination of a denial of a claim for benefits
under the internal review procedure under
section 503A;
‘‘(iv) except as provided in subpara-
graph (B)(ii), require payment of a filing
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fee to the plan or issuer of a sum that does
not exceed $50; and
‘‘(v) require that a request for review
include the consent of the participant or
beneficiary (or authorized representative)
for the release of medical information or
records of the participant or beneficiary to
the qualified external review entity for pur-
poses of conducting external review activi-
ties.
‘‘(B) REQUIREMENTS AND EXCEPTION RE-
LATING TO GENERAL RULE.—
‘‘(i) ORAL
REQUESTS
PERMITTED
IN
EXPEDITED
OR
CONCURRENT
CASES.—In
the case of an expedited or concurrent exter-
nal review as provided for under subsection
(e), the request may be made orally. In such
case a written confirmation of such request
shall be made in a timely manner. Such
written confirmation shall be treated as a
consent 
for 
purposes 
of 
subparagraph
(A)(v).
‘‘(ii) EXCEPTION TO FILING FEE RE-
QUIREMENT.—
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‘‘(I) INDIGENCY.—Payment of a
filing fee shall not be required under
subparagraph (A)(iv) where there is a
certification (in a form and manner
specified in guidelines established by
the Secretary) that the participant or
beneficiary is indigent (as defined in
such guidelines). In establishing guide-
lines under this subclause, the Sec-
retary shall ensure that the guidelines
relating to indigency are consistent
with the poverty guidelines used by the
Secretary of Health and Human Serv-
ices under title XIX of the Social Secu-
rity Act.
‘‘(II) FEE NOT REQUIRED.—Pay-
ment of a filing fee shall not be re-
quired under subparagraph (A)(iv) if
the plan or issuer waives the internal
appeals 
process 
under 
section
503A(b)(1)(D).
‘‘(III) REFUNDING OF FEE.—The
filing fee paid under subparagraph
(A)(iv) shall be refunded if the deter-
mination under the independent exter-
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nal review is to reverse the denial
which is the subject of the review.
‘‘(IV) INCREASE
IN
AMOUNT.—
The amount referred to in subclause (I)
shall be increased or decreased, for each
calendar year that ends after December
31, 2001, by the same percentage as the
percentage by which the Consumer
Price Index for All Urban Consumers
(United States city average), published
by the Bureau of Labor Statistics, for
September of the preceding calendar
year has increased or decreased from
the such Index for September of 2001.
‘‘(c) REFERRAL TO QUALIFIED EXTERNAL REVIEW
ENTITY UPON REQUEST.—
‘‘(1) IN GENERAL.—Upon the filing of a request
for independent external review with the group health
plan, or health insurance issuer offering coverage in
connection with a group health plan, the plan or
issuer shall refer such request to a qualified external
review entity selected in accordance with this section.
‘‘(2) ACCESS TO PLAN OR ISSUER AND HEALTH
PROFESSIONAL
INFORMATION.—With respect to an
independent external review conducted under this sec-
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tion, the participant or beneficiary (or authorized
representative), the plan or issuer, and the treating
health care professional (if any) shall provide the ex-
ternal review entity with access to information that
is necessary to conduct a review under this section, as
determined by the entity, not later than 5 business
days after the date on which a request is referred to
the qualified external review entity under paragraph
(1), or earlier as determined appropriate by the enti-
ty to meet the applicable timelines under clauses (ii)
and (iii) of subsection (e)(1)(A).
‘‘(3) SCREENING OF REQUESTS BY QUALIFIED
EXTERNAL REVIEW ENTITIES.—
‘‘(A) IN GENERAL.—With respect to a re-
quest referred to a qualified external review enti-
ty under paragraph (1) relating to a denial of
a claim for benefits, the entity shall refer such
request for the conduct of an independent med-
ical review unless the entity determines that—
‘‘(i) any of the conditions described in
subsection (b)(2)(A) have not been met;
‘‘(ii) the thresholds described in sub-
paragraph (B) have not been met;
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‘‘(iii) the denial of the claim for bene-
fits does not involve a medically reviewable
decision under subsection (d)(2);
‘‘(iv) the denial of the claim for bene-
fits relates to a decision regarding whether
an individual is a participant or bene-
ficiary who is enrolled under the terms of
the plan or coverage (including the applica-
bility of any waiting period under the plan
or coverage); or
‘‘(v) 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)(C);
Upon making a determination that any of
clauses (i) through (v) 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),
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and shall provide notice in accordance with sub-
paragraph (D).
‘‘(B) THRESHOLDS.—
‘‘(i) IN GENERAL.—The thresholds de-
scribed in this subparagraph are that—
‘‘(I) the total amount payable
under the plan or coverage for the item
or service that was the subject of such
denial exceeds a significant financial
threshold (as determined under guide-
lines established by the Secretary); or
‘‘(II) a physician has asserted in
writing that there is a significant risk
of placing the life, health, or develop-
ment of the participant or beneficiary
in jeopardy if the denial of the claim
for benefits is sustained.
‘‘(ii) THRESHOLDS
NOT
APPLIED.—
The thresholds described in this subpara-
graph shall not apply if the plan or issuer
involved waives the internal appeals process
with respect to the denial of a claim for
benefits 
involved 
under 
section
503A(b)(1)(D).
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‘‘(C) PROCESS
FOR
MAKING
DETERMINA-
TIONS.—
‘‘(i) NO DEFERENCE TO PRIOR DETER-
MINATIONS.—In 
making 
determinations
under subparagraph (A), there shall be no
deference given to determinations made by
the plan or issuer under section 503A or the
recommendation of a treating health care
professional (if any).
‘‘(ii) USE
OF
APPROPRIATE
PER-
SONNEL.—A qualified external review entity
shall use appropriately qualified personnel
to make determinations under this section.
‘‘(D) NOTICES
AND
GENERAL
TIMELINES
FOR DETERMINATION.—
‘‘(i) NOTICE IN CASE OF DENIAL OF
REFERRAL.—If the entity under this para-
graph does not make a referral to an inde-
pendent medical reviewer, the entity shall
provide notice to the plan or issuer, the par-
ticipant or beneficiary (or authorized rep-
resentative) filing the request, and the treat-
ing health care professional (if any) that
the denial is not subject to independent
medical review. Such notice—
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‘‘(I) shall be written (and, in ad-
dition, may be provided orally) in a
manner calculated to be understood by
an average participant;
‘‘(II) shall include the reasons for
the determination; and
‘‘(III) include any relevant terms
and conditions of the plan or coverage.
‘‘(ii) GENERAL TIMELINE FOR DETER-
MINATIONS.—Upon receipt of information
under paragraph (2), the qualified external
review entity, and if required the inde-
pendent medical reviewer, shall make a de-
termination within the overall timeline that
is applicable to the case under review as de-
scribed in subsection (e), except that if the
entity determines that a referral to an inde-
pendent medical reviewer is not required,
the entity shall provide notice of such deter-
mination to the participant or beneficiary
(or authorized representative) within 2
business days of such determination.
‘‘(d) INDEPENDENT MEDICAL REVIEW.—
‘‘(1) IN GENERAL.—If a qualified external review
entity determines under subsection (c) that a denial
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of a claim for benefits is eligible for independent med-
ical review, the entity shall refer the denial involved
to an independent medical reviewer for the conduct of
an independent medical review under this subsection.
‘‘(2) MEDICALLY
REVIEWABLE
DECISIONS.—A
denial described in this paragraph is one for which
the item or service that is the subject of the denial
would be a covered benefit under the terms and condi-
tions of the plan or coverage but for one (or more) of
the following determinations:
‘‘(A) DENIALS BASED ON MEDICAL NECES-
SITY AND APPROPRIATENESS.—The basis of the
determination is that the item or service is not
medically necessary and appropriate.
‘‘(B) DENIALS
BASED
ON
EXPERIMENTAL
OR INVESTIGATIONAL TREATMENT.—The basis of
the determination is that the item or service is
experimental or investigational.
‘‘(C) DENIALS
OTHERWISE
BASED
ON
AN
EVALUATION OF MEDICAL FACTS.—A determina-
tion that the item or service or condition is not
covered but an evaluation of the medical facts by
a health care professional in the specific case in-
volved is necessary to determine whether the item
or service or condition is required to be provided
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under the terms and conditions of the plan or
coverage.
‘‘(3) INDEPENDENT
MEDICAL
REVIEW
DETER-
MINATION.—
‘‘(A) IN GENERAL.—An independent med-
ical reviewer under this section shall make a new
independent determination with respect to—
‘‘(i) whether the item or service or con-
dition that is the subject of the denial is
covered under the terms and conditions of
the plan or coverage; and
‘‘(ii) based upon an affirmative deter-
mination under clause (i), whether or not
the denial of a claim for a benefit that is
the subject of the review should be upheld or
reversed.
‘‘(B) STANDARD FOR DETERMINATION.—The
independent medical reviewer’s determination re-
lating to the medical necessity and appropriate-
ness, or the experimental or investigation nature,
or the evaluation of the medical facts of the item,
service, or condition shall be based on the med-
ical condition of the participant or beneficiary
(including the medical records of the participant
or beneficiary) and the valid, relevant scientific
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evidence and clinical evidence, including peer-re-
viewed medical literature or findings and in-
cluding expert consensus.
‘‘(C) NO COVERAGE FOR EXCLUDED BENE-
FITS.—Nothing in this subsection shall be con-
strued to permit an independent medical re-
viewer to require that a group health plan, or
health insurance issuer offering health insurance
coverage in connection with a group health plan,
provide coverage for items or services that are
specifically excluded or expressly limited under
the plan or coverage and that are not covered re-
gardless of any determination relating to med-
ical necessity and appropriateness, experimental
or investigational nature of the treatment, or an
evaluation of the medical facts in the case in-
volved.
‘‘(D) EVIDENCE AND INFORMATION TO BE
USED IN MEDICAL REVIEWS.—In making a de-
termination under this subsection, the inde-
pendent medical reviewer shall also consider ap-
propriate and available evidence and informa-
tion, including the following:
‘‘(i) The determination made by the
plan or issuer with respect to the claim
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upon internal review and the evidence or
guidelines used by the plan or issuer in
reaching such determination.
‘‘(ii) The recommendation of the treat-
ing health care professional and the evi-
dence, guidelines, and rationale used by the
treating health care professional in reaching
such recommendation.
‘‘(iii) Additional evidence or informa-
tion obtained by the reviewer or submitted
by the plan, issuer, participant or bene-
ficiary (or an authorized representative), or
treating health care professional.
‘‘(iv) The plan or coverage document.
‘‘(E) INDEPENDENT
DETERMINATION.—In
making the determination, the independent med-
ical reviewer shall—
‘‘(i) consider the claim under review
without deference to the determinations
made by the plan or issuer under section
503A or the recommendation of the treating
health care professional (if any);
‘‘(ii) consider, but not be bound by the
definition used by the plan or issuer of
‘medically necessary and appropriate’, or
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‘experimental or investigational’, or other
equivalent terms that are used by the plan
or issuer to describe medical necessity and
appropriateness or experimental or inves-
tigational nature of the treatment; and
‘‘(iii) notwithstanding clause (ii), ad-
here to the definition used by the plan or
issuer of ‘medically necessary and appro-
priate’, or ‘experimental or investigational’
if such definition is the same as the defini-
tion of such term—
‘‘(I) that has been adopted pursu-
ant to a State statute or regulation; or
‘‘(II) that is used for purposes of
the program established under titles
XVIII or XIX of the Social Security
Act or under chapter 89 of title 5,
United States Code.
‘‘(F) DETERMINATION
OF
INDEPENDENT
MEDICAL
REVIEWER.—An independent medical
reviewer shall, in accordance with the deadlines
described in subsection (e), prepare a written de-
termination to uphold or reverse the denial
under review. Such written determination shall
include the specific reasons of the reviewer for
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such determination, including a summary of the
clinical or scientific-evidence based rationale
used in making the determination. The reviewer
may provide the plan or issuer and the treating
health care professional with additional rec-
ommendations in connection with such a deter-
mination, but any such recommendations shall
not be treated as part of the determination.
‘‘(e) TIMELINES AND NOTIFICATIONS.—
‘‘(1) TIMELINES FOR INDEPENDENT MEDICAL RE-
VIEW.—
‘‘(A) PRIOR
AUTHORIZATION
DETERMINA-
TION.—
‘‘(i) IN
GENERAL.—The independent
medical reviewer (or reviewers) shall make
a determination on a denial of a claim for
benefits that is referred to the reviewer
under subsection (c)(3) not later than 14
business days after the receipt of informa-
tion under subsection (c)(2) if the review
involves a prior authorization of items or
services.
‘‘(ii) EXPEDITED
DETERMINATION.—
Notwithstanding clause (i), the independent
medical reviewer (or reviewers) shall make
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an expedited determination on a denial of
a claim for benefits described in clause (i),
when a request for such an expedited deter-
mination is made by a participant or bene-
ficiary (or authorized representative) at any
time during the process for making a deter-
mination, and the treating health care pro-
fessional substantiates, with the request,
that a determination under the timeline de-
scribed in clause (i) would seriously jeop-
ardize the life or health of the participant
or beneficiary. Such determination shall be
made not later than 72 hours after the re-
ceipt of information under subsection (c)(2).
‘‘(iii) 
CONCURRENT
DETERMINA-
TION.—Notwithstanding clause (i), a review
described in such subclause shall be com-
pleted not later than 24 hours after the re-
ceipt of information under subsection (c)(2)
if the review involves a discontinuation of
inpatient care.
‘‘(B) RETROSPECTIVE
DETERMINATION.—
The independent medical reviewer (or reviewers)
shall complete a review in the case of a retrospec-
tive determination on an appeal of a denial of
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a claim for benefits that is referred to the re-
viewer under subsection (c)(3) not later than 30
business days after the receipt of information
under subsection (c)(2).
‘‘(2) NOTIFICATION
OF
DETERMINATION.—The
external review entity shall ensure that the plan or
issuer, the participant or beneficiary (or authorized
representative) and the treating health care profes-
sional (if any) receives a copy of the written deter-
mination of the independent medical reviewer pre-
pared under subsection (d)(3)(F). Nothing in this
paragraph shall be construed as preventing an entity
or reviewer from providing an initial oral notice of
the reviewer’s determination.
‘‘(3) FORM
OF
NOTICES.—Determinations and
notices under this subsection shall be written in a
manner calculated to be understood by an average
participant.
‘‘(4) TERMINATION OF EXTERNAL REVIEW PROC-
ESS IF APPROVAL OF A CLAIM FOR BENEFITS DURING
PROCESS.—
‘‘(A) IN GENERAL.—If a plan or issuer—
‘‘(i) reverses a determination on a de-
nial of a claim for benefits that is the sub-
ject of an external review under this section
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and authorizes coverage for the claim or
provides payment of the claim; and
‘‘(ii) provides notice of such reversal to
the participant or beneficiary (or author-
ized representative) and the treating health
care professional (if any), and the external
review entity responsible for such review,
the external review process shall be terminated
with respect to such denial and any filing fee
paid under subsection (b)(2)(A)(iv) shall be re-
funded.
‘‘(B) TREATMENT
OF
TERMINATION.—An
authorization of coverage under subparagraph
(A) by the plan or issuer shall be treated as a
written determination to reverse a denial under
section (d)(3)(F) for purposes of liability under
section 502(n)(1)(B).
‘‘(f) COMPLIANCE.—
‘‘(1) APPLICATION OF DETERMINATIONS.—
‘‘(A) EXTERNAL REVIEW DETERMINATIONS
BINDING ON PLAN.—The determinations of an
external review entity and an independent med-
ical reviewer under this section shall be binding
upon the plan or issuer involved.
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‘‘(B) COMPLIANCE WITH DETERMINATION.—
If the determination of an independent medical
reviewer is to reverse the denial, the plan or
issuer, upon the receipt of such determination,
shall authorize coverage to comply with the med-
ical reviewer’s determination in accordance with
the timeframe established by the medical re-
viewer.
‘‘(2) FAILURE TO COMPLY.—If a plan or issuer
fails to comply with the timeframe established under
paragraph (1)(B)(i) with respect to a participant or
beneficiary, where such failure to comply is caused by
the plan or issuer, the participant or beneficiary 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.
‘‘(3) REIMBURSEMENT.—
‘‘(A) IN GENERAL.—Where a participant or
beneficiary obtains items or services in accord-
ance with paragraph (2), the plan or issuer in-
volved shall provide for reimbursement of the
costs of such items of services. Such reimburse-
ment shall be made to the treating health care
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professional or to the participant or beneficiary
(in the case of a participant or beneficiary who
pays for the costs of such items or services).
‘‘(B) AMOUNT.—The plan or issuer shall
fully reimburse a professional, participant or
beneficiary under subparagraph (A) for the total
costs of the items or services provided (regardless
of any plan limitations that may apply to the
coverage of such items of services) so long as—
‘‘(i) the items or services would have
been covered under the terms of the plan or
coverage if provided by the plan or issuer;
and
‘‘(ii) the items or services were pro-
vided in a manner consistent with the de-
termination of the independent medical re-
viewer.
‘‘(4) FAILURE TO REIMBURSE.—Where a plan or
issuer fails to provide reimbursement to a profes-
sional, participant or beneficiary in accordance with
this subsection, the professional, participant or bene-
ficiary may commence a civil action (or utilize other
remedies available under law) to recover only the
amount of any such reimbursement that is unpaid
and any necessary legal costs or expenses (including
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attorneys’ fees) incurred in recovering such reimburse-
ment.
‘‘(g) QUALIFICATIONS OF INDEPENDENT MEDICAL RE-
VIEWERS.—
‘‘(1) IN GENERAL.—In referring a denial to 1 or
more individuals to conduct independent medical re-
view under subsection (c), the qualified external re-
view entity shall ensure that—
‘‘(A) each independent medical reviewer
meets the qualifications described in paragraphs
(2) and (3);
‘‘(B) with respect to each review at least 1
such reviewer meets the requirements described
in paragraphs (4) and (5); and
‘‘(C) compensation provided by the entity to
the reviewer is consistent with paragraph (6).
‘‘(2) LICENSURE AND EXPERTISE.—Each inde-
pendent medical reviewer shall be a physician or
health care professional who—
‘‘(A) is appropriately credentialed or li-
censed in 1 or more States to deliver health care
services; and
‘‘(B) typically treats the diagnosis or condi-
tion or provides the type or treatment under re-
view.
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‘‘(3) INDEPENDENCE.—
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), each independent medical reviewer in
a case shall—
‘‘(i) not be a related party (as defined
in paragraph (7));
‘‘(ii) not have a material familial, fi-
nancial, or professional relationship with
such a party; and
‘‘(iii) not otherwise have a conflict of
interest with such a party (as determined
under regulations).
‘‘(B) EXCEPTION.—Nothing in this sub-
paragraph (A) shall be construed to—
‘‘(i) prohibit an individual, solely on
the basis of affiliation with the plan or
issuer, from serving as an independent med-
ical reviewer if—
‘‘(I) a non-affiliated individual is
not reasonably available;
‘‘(II) the affiliated individual is
not involved in the provision of items
or services in the case under review;
and
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‘‘(III) the fact of such an affili-
ation is disclosed to the plan or issuer
and the participant or beneficiary (or
authorized representative) and neither
party objects;
‘‘(ii) prohibit an individual who has
staff privileges at the institution where the
treatment involved takes place from serving
as an independent medical reviewer if the
affiliation is disclosed to the plan or issuer
and the participant or beneficiary (or au-
thorized representative), and neither party
objects;
‘‘(iii) permit an employee of a plan or
issuer, or an individual who provides serv-
ices exclusively or primarily to or on behalf
of a plan or issuer, from serving as an inde-
pendent medical reviewer; or
‘‘(iv) prohibit receipt of compensation
by an independent medical reviewer from
an entity if the compensation is provided
consistent with paragraph (6).
‘‘(4) PRACTICING HEALTH CARE PROFESSIONAL
IN SAME FIELD.—
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‘‘(A) IN GENERAL.—The requirement of this
paragraph with respect to a reviewer in a case
involving treatment, or the provision of items or
services, by—
‘‘(i) a physician, is that the reviewer
be a practicing physician of the same or
similar specialty, when reasonably avail-
able, as a physician who typically treats the
diagnosis or condition or provides such
treatment in the case under review; or
‘‘(ii) a health care professional (other
than a physician), is that the reviewer be a
practicing physician or, if determined ap-
propriate by the qualified external review
entity, a health care professional (other
than a physician), of the same or similar
specialty as the health care professional who
typically treats the diagnosis or condition
or provides the treatment in the case under
review.
‘‘(B) PRACTICING DEFINED.—For pur-
poses of this paragraph, the term ‘prac-
ticing’ means, with respect to an individual
who is a physician or other health care pro-
fessional that the individual provides health
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care services to individual patients on aver-
age at least 1 day per week.
‘‘(5) AGE-APPROPRIATE EXPERTISE.—The inde-
pendent medical reviewer shall have expertise under
paragraph (2) that is age-appropriate to the partici-
pant or beneficiary involved.
‘‘(6) LIMITATIONS
ON
REVIEWER
COMPENSA-
TION.—Compensation provided by a qualified exter-
nal review entity to an independent medical reviewer
in connection with a review under this section shall—
‘‘(A) not exceed a reasonable level; and
‘‘(B) not be contingent on the decision ren-
dered by the reviewer.
‘‘(7) RELATED PARTY DEFINED.—For purposes
of this section, the term ‘related party’ means, with
respect to a denial of a claim under a plan or cov-
erage relating to a participant or beneficiary, any of
the following:
‘‘(A) The plan, plan sponsor, or issuer in-
volved, or any fiduciary, officer, director, or em-
ployee of such plan, plan sponsor, or issuer.
‘‘(B) The participant or beneficiary (or au-
thorized representative).
‘‘(C) The health care professional that pro-
vides the items of services involved in the denial.
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‘‘(D) The institution at which the items or
services (or treatment) involved in the denial are
provided.
‘‘(E) The manufacturer of any drug or
other item that is included in the items or serv-
ices involved in the denial.
‘‘(F) Any other party determined under any
regulations to have a substantial interest in the
denial involved.
‘‘(h) QUALIFIED EXTERNAL REVIEW ENTITIES.—
‘‘(1) SELECTION OF QUALIFIED EXTERNAL RE-
VIEW ENTITIES.—
‘‘(A) LIMITATION ON PLAN OR ISSUER SE-
LECTION.—The Secretary shall implement proce-
dures with respect to the selection of qualified ex-
ternal review entities by a plan or issuer to as-
sure that the selection process among qualified
external review entities will not create any in-
centives for external review entities to make a de-
cision in a biased manner.
‘‘(B) STATE AUTHORITY WITH RESPECT TO
QUALIFIED
EXTERNAL
REVIEW
ENTITIES
FOR
HEALTH INSURANCE ISSUERS.—With respect to
health insurance issuers offering health insur-
ance coverage in connection with a group health
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plan in a State, the State may, pursuant to a
State law that is enacted after the date of enact-
ment of the Patients’ Bill of Rights Plus Act,
provide for the designation or selection of quali-
fied external review entities in a manner deter-
mined by the State to assure an unbiased deter-
mination in conducting external review activi-
ties. In conducting reviews under this section, an
entity designated or selected under this subpara-
graph shall comply with the provision of this
section.
‘‘(2) CONTRACT WITH QUALIFIED EXTERNAL RE-
VIEW
ENTITY.—Except as provided in paragraph
(1)(B), the external review process of a plan or issuer
under this section shall be conducted under a contract
between the plan or issuer and 1 or more qualified ex-
ternal review entities (as defined in paragraph
(4)(A)).
‘‘(3) TERMS AND CONDITIONS OF CONTRACT.—
The terms and conditions of a contract under para-
graph (2) shall—
‘‘(A) be consistent with the standards the
Secretary shall establish to assure there is no
real or apparent conflict of interest in the con-
duct of external review activities; and
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‘‘(B) provide that the costs of the external
review process shall be borne by the plan or
issuer.
Subparagraph (B) shall not be construed as applying
to the imposition of a filing fee under subsection
(b)(2)(A)(iv) or costs incurred by the participant or
beneficiary (or authorized representative) or treating
health care professional (if any) in support of the re-
view, including the provision of additional evidence
or information.
‘‘(4) QUALIFICATIONS.—
‘‘(A) IN
GENERAL.—In this section, the
term ‘qualified external review entity’ means, in
relation to a plan or issuer, an entity that is
initially certified (and periodically recertified)
under subparagraph (C) as meeting the following
requirements:
‘‘(i) The entity has (directly or through
contracts or other arrangements) sufficient
medical, legal, and other expertise and suffi-
cient staffing to carry out duties of a quali-
fied external review entity under this sec-
tion on a timely basis, including making
determinations under subsection (b)(2)(A)
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and providing for independent medical re-
views under subsection (d).
‘‘(ii) The entity is not a plan or issuer
or an affiliate or a subsidiary of a plan or
issuer, and is not an affiliate or subsidiary
of a professional or trade association of
plans or issuers or of health care providers.
‘‘(iii) The entity has provided assur-
ances that it will conduct external review
activities consistent with the applicable re-
quirements of this section and standards
specified in subparagraph (C), including
that it will not conduct any external review
activities in a case unless the independence
requirements of subparagraph (B) are met
with respect to the case.
‘‘(iv) The entity has provided assur-
ances that it will provide information in a
timely manner under subparagraph (D).
‘‘(v) The entity meets such other re-
quirements as the Secretary provides by reg-
ulation.
‘‘(B) INDEPENDENCE REQUIREMENTS.—
‘‘(i) IN
GENERAL.—Subject to clause
(ii), an entity meets the independence re-
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quirements of this subparagraph with re-
spect to any case if the entity—
‘‘(I) is not a related party (as de-
fined in subsection (g)(7));
‘‘(II) does not have a material fa-
milial, financial, or professional rela-
tionship with such a party; and
‘‘(III) does not otherwise have a
conflict of interest with such a party
(as determined under regulations).
‘‘(ii) EXCEPTION
FOR
REASONABLE
COMPENSATION.—Nothing in clause (i) shall
be construed to prohibit receipt by a quali-
fied external review entity of compensation
from a plan or issuer for the conduct of ex-
ternal review activities under this section if
the compensation is provided consistent
with clause (iii).
‘‘(iii) LIMITATIONS
ON
ENTITY
COM-
PENSATION.—Compensation provided by a
plan or issuer to a qualified external review
entity in connection with reviews under this
section shall—
‘‘(I) not exceed a reasonable level;
and
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‘‘(II) not be contingent on the de-
cision rendered by the entity or by any
independent medical reviewer.
‘‘(C) CERTIFICATION AND RECERTIFICATION
PROCESS.—
‘‘(i) IN GENERAL.—The initial certifi-
cation and recertification of a qualified ex-
ternal review entity shall be made—
‘‘(I) under a process that is recog-
nized or approved by the Secretary; or
‘‘(II) by a qualified private stand-
ard-setting organization that is ap-
proved by the Secretary under clause
(iii).
‘‘(ii) PROCESS.—The Secretary shall
not recognize or approve a process under
clause (i)(I) unless the process applies
standards (as promulgated in regulations)
that ensure that a qualified external review
entity—
‘‘(I) will carry out (and has car-
ried out, in the case of recertification)
the responsibilities of such an entity in
accordance with this section, including
meeting applicable deadlines;
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‘‘(II) will meet (and has met, in
the case of recertification) appropriate
indicators of fiscal integrity;
‘‘(III) will maintain (and has
maintained, in the case of recertifi-
cation) 
appropriate 
confidentiality
with respect to individually identifi-
able health information obtained in the
course of conducting external review
activities; and
‘‘(IV) in the case recertification,
shall review the matters described in
clause (iv).
‘‘(iii) APPROVAL
OF
QUALIFIED
PRI-
VATE
STANDARD-SETTING
ORGANIZA-
TIONS.—For purposes of clause (i)(II), the
Secretary may approve a qualified private
standard-setting organization if the Sec-
retary finds that the organization only cer-
tifies (or recertifies) external review entities
that meet at least the standards required for
the certification (or recertification) of exter-
nal review entities under clause (ii).
‘‘(iv) CONSIDERATIONS IN RECERTIFI-
CATIONS.—In conducting recertifications of
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a qualified external review entity under this
paragraph, the Secretary or organization
conducting the recertification shall review
compliance of the entity with the require-
ments for conducting external review activi-
ties under this section, including the fol-
lowing:
‘‘(I) Provision of information
under subparagraph (D).
‘‘(II) 
Adherence 
to 
applicable
deadlines (both by the entity and by
independent medical reviewers it refers
cases to).
‘‘(III) Compliance with limita-
tions on compensation (with respect to
both the entity and independent med-
ical reviewers it refers cases to).
‘‘(IV) Compliance with applicable
independence requirements.
‘‘(v) PERIOD OF CERTIFICATION OR RE-
CERTIFICATION.—A certification or recer-
tification provided under this paragraph
shall extend for a period not to exceed 5
years.
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‘‘(vi) REVOCATION.—A certification or
recertification under this paragraph may be
revoked by the Secretary or by the organiza-
tion providing such certification upon a
showing of cause.
‘‘(D) PROVISION OF INFORMATION.—
‘‘(i) IN GENERAL.—A qualified exter-
nal review entity shall provide to the Sec-
retary, in such manner and at such times
as the Secretary may require, such informa-
tion (relating to the denials which have been
referred to the entity for the conduct of ex-
ternal review under this section) as the Sec-
retary determines appropriate to assure
compliance with the independence and other
requirements of this section to monitor and
assess the quality of its external review ac-
tivities and lack of bias in making deter-
minations. Such information shall include
information described in clause (ii) but
shall not include individually identifiable
medical information.
‘‘(ii) 
INFORMATION
TO
BE
IN-
CLUDED.—The information described in
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this subclause with respect to an entity is as
follows:
‘‘(I) The number and types of de-
nials for which a request for review has
been received by the entity.
‘‘(II) The disposition by the entity
of such denials, including the number
referred to a independent medical re-
viewer and the reasons for such dis-
positions (including the application of
exclusions), on a plan or issuer-specific
basis and on a health care specialty-
specific basis.
‘‘(III) The length of time in mak-
ing determinations with respect to such
denials.
‘‘(IV) Updated information on the
information required to be submitted
as a condition of certification with re-
spect to the entity’s performance of ex-
ternal review activities.
‘‘(iii) INFORMATION TO BE PROVIDED
TO CERTIFYING ORGANIZATION.—
‘‘(I) IN GENERAL.—In the case of
a qualified external review entity
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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 Secretary
under clause (i).
‘‘(II) 
ADDITIONAL
INFORMA-
TION.—Nothing in this subparagraph
shall be construed as preventing such
an organization from requiring addi-
tional information as a condition of
certification or recertification of an en-
tity.
‘‘(iv) USE OF INFORMATION.—Informa-
tion provided under this subparagraph may
be used by the Secretary and qualified pri-
vate standard-setting organizations to con-
duct oversight of qualified external review
entities, including recertification of such en-
tities, and shall be made available to the
public in an appropriate manner.
‘‘(E) LIMITATION ON LIABILITY.—No quali-
fied external review entity having a contract
with a plan or issuer, and no person who is em-
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ployed by any such entity or who furnishes pro-
fessional 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.
‘‘(i) DEFINITIONS.—In this section:
‘‘(1) AUTHORIZED REPRESENTATIVE.—The term
‘authorized representative’ means, with respect to a
participant or beneficiary—
‘‘(A) a person to whom a participant or
beneficiary has given express written consent to
represent the participant or beneficiary in any
proceeding under this section;
‘‘(B) a person authorized by law to provide
substituted consent for the participant or bene-
ficiary; or
‘‘(C) a family member of the participant or
beneficiary (or the estate of the participant or
beneficiary) or the participant’s or beneficiary’s
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treating health care professional when the partic-
ipant or beneficiary is unable to provide consent.
‘‘(2) CLAIM FOR BENEFITS.—The term ‘claim for
benefits’ means any request by a participant or bene-
ficiary (or authorized representative) for benefits (in-
cluding requests that are subject to authorization of
coverage or utilization review), for eligibility, or for
payment in whole or in part, for an item or service
under a group health plan or health insurance cov-
erage offered by a health insurance issuer in connec-
tion with a group health plan.
‘‘(3) GROUP HEALTH PLAN.—The term ‘group
health plan’ shall have the meaning given such term
in section 733(a). In applying this paragraph, ex-
cepted benefits described in section 733(c) shall not be
treated as benefits consisting of medical care.
‘‘(4) HEALTH INSURANCE COVERAGE.—The term
‘health insurance coverage’ has the meaning given
such term in section 733(b)(1). In applying this
paragraph, excepted benefits described in section
733(c) shall not be treated as benefits consisting of
medical care.
‘‘(5) HEALTH
INSURANCE
ISSUER.—The term
‘health insurance issuer’ has the meaning given such
term in section 733(b)(2).
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‘‘(6) PRIOR AUTHORIZATION DETERMINATION.—
The term ‘prior authorization determination’ means a
determination by the group health plan or health in-
surance issuer offering health insurance coverage in
connection with a group health plan prior to the pro-
vision of the items and services as a condition of cov-
erage of the items and services under the terms and
conditions of the plan or coverage.
‘‘(7) TREATING HEALTH CARE PROFESSIONAL.—
The term ‘treating health care professional’ with re-
spect to a group health plan, health insurance issuer
or provider sponsored organization means a physi-
cian (medical doctor or doctor of osteopathy) or other
health care practitioner who is acting within the
scope of his or her State licensure or certification for
the delivery of health care services and who is pri-
marily responsible for delivering those services to the
participant or beneficiary.
‘‘(8) UTILIZATION REVIEW.—The term ‘utiliza-
tion review’ with respect to a group health plan or
health insurance coverage means procedures used in
the determination of coverage for a participant or
beneficiary, such as procedures to evaluate the med-
ical necessity, appropriateness, efficacy, quality, or ef-
ficiency of health care services, procedures or settings,
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and includes prospective review, concurrent review,
second opinions, case management, discharge plan-
ning, or retrospective review.’’.
(b) CONFORMING AMENDMENT.—The table of contents
in section 1 of the Employee Retirement Income Security
Act of 1974 is amended by inserting after the item relating
to section 503 the following:
‘‘Sec. 503A. Claims and internal appeals procedures for group health plans.
‘‘Sec. 503B. Independent external appeals procedures for group health plans.’’.
(c) EFFECTIVE DATE.—The amendments made by this
section shall apply with respect to plan years beginning on
or after 2 years after the date of enactment of this Act. The
Secretary shall issue all regulations necessary to carry out
the amendments made by this section before the effective
date thereof.
SEC. 2222. ENFORCEMENT.
Section 502(c) of the Employee Retirement Income Se-
curity Act of 1974 (29 U.S.C. 1132(c)) is amended by add-
ing at the end the following:
‘‘(8) The Secretary may assess a civil penalty against
any plan of up to $10,000 for the plan’s failure or refusal
to comply with any deadline applicable under section 503B
or any determination under such section, except that in any
case in which treatment was not commenced by the plan
in accordance with the determination of an independent ex-
ternal reviewer, the Secretary shall assess a civil penalty
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of $10,000 against the plan and the plan shall pay such
penalty to the participant or beneficiary involved.’’.
Subtitle D—Remedies
SEC. 2231. AVAILABILITY OF COURT REMEDIES.
(a) IN GENERAL.—Section 502 of the Employee Re-
tirement Income Security Act of 1974 (29 U.S.C. 1132) is
amended by adding at the end the following:
‘‘(n) CAUSE OF ACTION RELATING TO DENIAL OF A
CLAIM FOR HEALTH BENEFITS.—
‘‘(1) IN GENERAL.—
‘‘(A) FAILURE TO COMPLY WITH EXTERNAL
MEDICAL REVIEW.—In any case in which—
‘‘(i) a designated decision-maker de-
scribed in paragraph (2) fails to exercise or-
dinary care in approving coverage pursuant
to the written determination of an inde-
pendent medical reviewer under section
503B(d)(3)(F) that reverses a denial of a
claim for benefits; and
‘‘(ii) the failure described in clause (i)
is the proximate cause of substantial harm
to, or the wrongful death of, the participant
or beneficiary;
such designated decision-maker shall be liable to
the participant or beneficiary (or the estate of
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such participant or beneficiary) for economic
and noneconomic damages in connection with
such failure and such injury or death (subject to
paragraph (4)).
‘‘(B) WRONGFUL DETERMINATION RESULT-
ING IN DELAY IN PROVIDING BENEFITS.—In any
case in which—
‘‘(i) a designated decision-maker de-
scribed in paragraph (2) acts in bad faith
in making a final determination denying a
claim for benefits under section 503A(b);
‘‘(ii) the denial described in clause (i)
is reversed by an independent medical re-
viewer under section 503B(d); and
‘‘(iii) the delay attributable to the fail-
ure described in clause (i) is the proximate
cause of substantial harm to, or the wrong-
ful death of, the participant or beneficiary;
such designated decision-maker shall be liable to
the participant or beneficiary (or the estate of
such participant or beneficiary) for economic
and noneconomic damages in connection with
such failure and such injury or death (subject to
paragraph (4)).
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‘‘(2) DESIGNATED DECISION-MAKERS FOR PUR-
POSES OF LIABILITY.—An employer or plan sponsor
shall not be liable under any cause of action described
in paragraph (1) if the employer or plan sponsor
complies with the following provisions:
‘‘(A) APPOINTMENT.—A group health plan
may designate one or more persons to serve as
the designated decision-maker for purposes of
paragraph (1). Such designated decision-makers
shall have the exclusive authority under the
group health plan (or under the health insurance
coverage in the case of a health insurance issuer
offering coverage in connection with a group
health plan) to make determinations described in
section 503A with respect to claims for benefits
and determination to approve coverage pursuant
to written determination of independent medical
reviewers under section 503B, except that the
plan documents may expressly provide that the
designated decision-maker is subject to the direc-
tion of a named fiduciary.
‘‘(B) PROCEDURES.—A designated decision-
maker shall—
‘‘(i) be a person who is named in the
plan or coverage documents, or who, pursu-
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ant to procedures specified in the plan or
coverage documents, is identified as the des-
ignated decision-maker by—
‘‘(I) a person who is an employer
or employee organization with respect
to the plan or issuer;
‘‘(II) a person who is such an em-
ployer and such an employee organiza-
tion acting jointly; or
‘‘(III) a person who is a named
fiduciary;
‘‘(ii) agree to accept appointment as a
designated decision-maker; and
‘‘(iii) be identified in the plan or cov-
erage documents as required under section
714(b)(14).
‘‘(C) QUALIFICATIONS.—To be appointed as
a designated decision-maker under this para-
graph, a person shall be—
‘‘(i) a plan sponsor;
‘‘(ii) a group health plan;
‘‘(iii) a health insurance issuer; or
‘‘(iv) any other person who can pro-
vide adequate evidence, in accordance with
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regulations promulgated by the Secretary, of
the ability of the person to—
‘‘(I) carry out the responsibilities
set forth in the plan or coverage docu-
ments;
‘‘(II) carry out the applicable re-
quirements of this subsection; and
‘‘(III) meet other applicable re-
quirements under this Act, including
any financial obligation for liability
under this subsection.
‘‘(D) FLEXIBILITY IN ADMINISTRATION.—A
group health plan, or health insurance issuer of-
fering coverage in connection with a group
health plan, may provide—
‘‘(i) that any person or group of per-
sons may serve in more than one capacity
with respect to the plan or coverage (includ-
ing service as a designated decision-maker,
administrator, and named fiduciary); or
‘‘(ii) that a designated decision-maker
may employ one or more persons to provide
advice with respect to any responsibility of
such decision-maker under the plan or cov-
erage.
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‘‘(E) FAILURE TO DESIGNATE.—In any case
in which a designated decision-maker is not ap-
pointed under this paragraph, the group health
plan (or health insurance issuer offering coverage
in connection with the group health plan), the
administrator, or the party or parties that bears
the sole responsibility for making the final deter-
mination under section 503A(b) (with respect to
an internal review), or for approving coverage
pursuant to the written determination of an
independent medical reviewer under section
503B, with respect to a denial of a claim for
benefits shall be treated as the designated deci-
sion-maker for purposes of liability under this
section.
‘‘(3) REQUIREMENT OF EXHAUSTION OF INDE-
PENDENT
MEDICAL
REVIEW.—Paragraph (1) shall
apply only if a final determination denying a claim
for benefits under section 503A(b) has been referred
for independent medical review under section 503B(d)
and a written determination by an independent med-
ical reviewer to reverse such final determination has
been issued with respect to such review.
‘‘(4) LIMITATIONS ON RECOVERY OF DAMAGES.—
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‘‘(A) MAXIMUM
AWARD
OF
NONECONOMIC
DAMAGES.—The aggregate amount of liability
for noneconomic loss in an action under para-
graph (1) may not exceed $350,000.
‘‘(B) INCREASE IN AMOUNT.—The amount
referred to in subparagraph (A) shall be in-
creased or decreased, for each calendar year that
ends after December 31, 2001, by the same per-
centage as the percentage by which the Consumer
Price Index for All Urban Consumers (United
States city average), published by the Bureau of
Labor Statistics, for September of the preceding
calendar year has increased or decreased from
the such Index for September of 2001.
‘‘(C) JOINT
AND
SEVERAL
LIABILITY.—In
the case of any action commenced pursuant to
paragraph (1), the defendant shall be liable only
for the amount of noneconomic damages attrib-
utable to such defendant in direct proportion to
such defendant’s share of fault or responsibility
for the injury suffered by the participant or ben-
eficiary. In all such cases, the liability of a de-
fendant for noneconomic damages shall be several
and not joint.
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‘‘(D) TREATMENT OF COLLATERAL SOURCE
PAYMENTS.—
‘‘(i) IN GENERAL.—In the case of any
action commenced pursuant to paragraph
(1), the total amount of damages received by
a participant or beneficiary under such ac-
tion shall be reduced, in accordance with
clause (ii), by any other payment that has
been, or will be, made to such participant
or beneficiary to compensate such partici-
pant or beneficiary for the injury that was
the subject of such action.
‘‘(ii) AMOUNT
OF
REDUCTION.—The
amount by which an award of damages to
a participant or beneficiary for an injury
shall be reduced under clause (i) shall be—
‘‘(I) the total amount of any pay-
ments (other than such award) that
have been made or that will be made to
such participant or beneficiary to pay
costs of or compensate such participant
or beneficiary for the injury that was
the subject of the action; less
‘‘(II) the amount paid by such
participant or beneficiary (or by the
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spouse, parent, or legal guardian of
such participant or beneficiary) to se-
cure the payments described in sub-
clause (I).
‘‘(iii) DETERMINATION
OF
AMOUNTS
FROM COLLATERAL SOURCES.—The reduc-
tion required under clause (ii) shall be de-
termined by the court in a pretrial pro-
ceeding. At the subsequent trial no evidence
shall be admitted as to the amount of any
charge, payments, or damage for which a
participant or beneficiary—
‘‘(I) has received payment from a
collateral source or the obligation for
which has been assured by a third
party; or
‘‘(II) is, or with reasonable cer-
tainty, will be eligible to receive from
a collateral source which will, with
reasonable certainty, be assumed by a
third party.
‘‘(5) AFFIRMATIVE DEFENSES.—In the case of
any cause of action under paragraph (1), it shall be
an affirmative defense that—
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‘‘(A) the group health plan, or health insur-
ance issuer offering health insurance coverage in
connection with a group health plan, involved
did not receive from the participant or bene-
ficiary (or authorized representative) or the
treating health care professional (if any), suffi-
cient information regarding the medical condi-
tion of the participant or beneficiary that was
necessary to make a final determination on a
claim for benefits under section 503A(b);
‘‘(B) the participant or beneficiary (or au-
thorized representative)—
‘‘(i) was in possession of facts that
were sufficient to enable the participant or
beneficiary (or authorized representative) to
know that an expedited review under sec-
tion 503A or 503B would have prevented
the harm that is the subject of the action;
and
‘‘(ii) failed to notify the plan or issuer
of the need for such an expedited review; or
‘‘(C) the cause of action is based solely on
the failure of a qualified external review entity
or an independent medical reviewer to meet the
timelines applicable under section 503B.
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Nothing in this paragraph shall be construed to limit
the application of any other affirmative defense that
may be applicable to the cause of action involved.
‘‘(6) WAIVER OF INTERNAL REVIEW.—In the case
of any cause of action under paragraph (1), the waiv-
er or nonwaiver of internal review under section
503A(b)(1)(D) by the group health plan, or health in-
surance issuer offering health insurance coverage in
connection with a group health plan, shall not be used
in determining liability.
‘‘(7) LIMITATIONS ON ACTIONS.—Paragraph (1)
shall not apply in connection with any action that is
commenced more than 1 year after—
‘‘(A) the date on which the last act occurred
which constituted a part of the failure referred to
in such paragraph; or
‘‘(B) in the case of an omission, the last
date on which the decision-maker could have
cured the failure.
‘‘(8) LIMITATION ON RELIEF WHERE DEFEND-
ANT’S POSITION PREVIOUSLY SUPPORTED UPON EX-
TERNAL REVIEW.—In any case in which the court
finds the defendant to be liable in an action under
this subsection, to the extent that such liability is
based on a finding by the court of a particular failure
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described in paragraph (1) and such finding is con-
trary to a previous determination by an independent
medical reviewer under section 503B(d) with respect
to such defendant, no relief shall be available under
this subsection in addition to the relief otherwise
available under subsection (a)(1)(B).
‘‘(9) CONSTRUCTION.—Nothing in this subsection
shall be construed as authorizing a cause of action
under paragraph (1) for—
‘‘(A) the failure of a group health plan or
health insurance issuer to provide an item or
service that is specifically excluded under the
plan or coverage; or
‘‘(B) any denial of a claim for benefits that
was not eligible for independent medical review
under section 503B(d).
‘‘(10) FEDERAL JURISDICTION.—In the case of
any action commenced pursuant to paragraph (1) the
district courts of the United States shall have exclu-
sive jurisdiction.
‘‘(11) DEFINITIONS.—In this subsection:
‘‘(A) AUTHORIZED REPRESENTATIVE.—The
term ‘authorized representative’ has the meaning
given such term in section 503B(i).
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‘‘(B) CLAIM
FOR
BENEFITS.—The term
‘claim for benefits’ shall have the meaning given
such term in section 503B(i), except that such
term shall only include claims for prior author-
ization determinations (as such term is defined
in section 503B(i)).
‘‘(C) GROUP
HEALTH
PLAN.—The term
‘group health plan’ shall have the meaning given
such term in section 733(a).
‘‘(D) HEALTH INSURANCE COVERAGE.—The
term ‘health insurance coverage’ has the meaning
given such term in section 733(b)(1).
‘‘(E) HEALTH
INSURANCE
ISSUER.—The
term ‘health insurance issuer’ has the meaning
given such term in section 733(b)(2) (including
health maintenance organizations as defined in
section 733(b)(3)).
‘‘(F) ORDINARY CARE.—The term ‘ordinary
care’ means the care, skill, prudence, and dili-
gence under the circumstances prevailing at the
time the care is provided that a prudent indi-
vidual acting in a like capacity and familiar
with the care being provided would use in pro-
viding care of a similar character.
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‘‘(G) SUBSTANTIAL HARM.—The term ‘sub-
stantial harm’ means the loss of life, loss or sig-
nificant impairment of limb or bodily function,
significant disfigurement, or severe and chronic
physical pain.
‘‘(12) EFFECTIVE DATE.—The provisions of this
subsection shall apply to acts and omissions occurring
on or after the date of enactment of this subsection.’’.
(b) IMMUNITY FROM LIABILITY FOR PROVISION OF IN-
SURANCE OPTIONS.—
(1) IN GENERAL.—Section 502 of the Employee
Retirement Income Security Act of 1974 (29 U.S.C.
1132), as amended by subsection (a), is further
amended by adding at the end the following:
‘‘(o) IMMUNITY FROM LIABILITY FOR PROVISION OF
INSURANCE OPTIONS.—
‘‘(1) IN GENERAL.—No liability shall arise under
subsection (n) with respect to a participant or bene-
ficiary against a group health plan (other than a
fully insured group health plan) if such plan offers
the participant or beneficiary the coverage option de-
scribed in paragraph (2).
‘‘(2) COVERAGE
OPTION.—The coverage option
described in this paragraph is one under which the
group health plan (other than a fully insured group
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health plan), at the time of enrollment or as provided
for in paragraph (3), provides the participant or ben-
eficiary with the option to—
‘‘(A) enroll for coverage under a fully in-
sured health plan; or
‘‘(B) receive an individual benefit payment,
in an amount equal to the amount that would be
contributed on behalf of the participant or bene-
ficiary by the plan sponsor for enrollment in the
group health plan, for use by the participant or
beneficiary in obtaining health insurance cov-
erage in the individual market.
‘‘(3) TIME OF OFFERING OF OPTION.—The cov-
erage option described in paragraph (2) shall be of-
fered to a participant or beneficiary—
‘‘(A) during the first period in which the
individual is eligible to enroll under the group
health plan; or
‘‘(B) during any special enrollment period
provided by the group health plan after the date
of enactment of the Patients’ Bill of Rights Plus
Act for purposes of offering such coverage op-
tion.’’.
(2) 
AMENDMENTS
TO
INTERNAL
REVENUE
CODE.—
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(A) EXCLUSION
FROM
INCOME.—Section
106 of the Internal Revenue Code of 1986 (relat-
ing to contributions by employer to accident and
health plans) is amended by adding at the end
the following:
‘‘(d) TREATMENT
OF CERTAIN COVERAGE OPTION
UNDER SELF-INSURED PLANS.—No amount shall be in-
cluded in the gross income of an individual by reason of—
‘‘(1) the individual’s right to elect a coverage op-
tion described in section 502(o)(2) of the Employee
Retirement Income Security Act of 1974, or
‘‘(2) the receipt by the individual of an indi-
vidual 
benefit 
payment 
described 
in 
section
502(o)(2)(A) of such Act.’’
(B) NONDISCRIMINATION
RULES.—Section
105(h) of such Code (relating to self-insured
medical expense reimbursement plans) is amend-
ed by adding at the end the following:
‘‘(11) TREATMENT OF CERTAIN COVERAGE OP-
TIONS.—If a self-insured medical reimbursement plan
offers the coverage option described in section
502(o)(2) of the Employee Retirement Income Secu-
rity Act of 1974, employees who elect such option
shall be treated as eligible to benefit under the plan
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and the plan shall be treated as benefiting such em-
ployees.’’
(c) CONFORMING AMENDMENT.—Section 502(a)(1)(A)
of the Employee Retirement Income Security Act of 1974
(29 U.S.C. 1132(a)(1)(A)) is amended by inserting ‘‘or (n)’’
after ‘‘subsection (c)’’.
SEC. 2232. LIMITATION ON CERTAIN CLASS ACTION LITIGA-
TION.
(a) ERISA.—Section 502 of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1132), as amended
by section 2231, is further amended by adding at the end
the following:
‘‘(p) LIMITATION ON CLASS ACTION LITIGATION.—A
claim or cause of action under section 502(n) may not be
maintained as a class action.’’.
(b) RICO.—Section 1964(c) of title 18, United States
Code, is amended—
(1) by inserting ‘‘(1)’’ after the subsection des-
ignation; and
(2) by adding at the end the following:
‘‘(2) No action may be brought under this subsection,
or alleging any violation of section 1962, against any per-
son where the action seeks relief for which a remedy may
be provided under section 502 of the Employee Retirement
Income Security Act of 1974.’’.
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(c) EFFECTIVE DATE.—
(1) IN
GENERAL.—The amendments made by
this section shall apply to all civil actions that are
filed on or after the date of enactment of this Act.
(2) PENDING CIVIL ACTIONS.—Notwithstanding
section 502(p) of the Employee Retirement Income
Security Act of 1974 and section 1964(c)(2) of title
18, United States Code, such sections 502(p) and
1964(c)(2) shall apply to civil actions that are pend-
ing and have not been finally determined by judg-
ment or settlement prior to the date of enactment of
this Act if such actions are substantially similar in
nature to the claims or causes of actions referred to
in such sections 502(p) and 1964(c)(2).
SEC. 2233. SEVERABILITY.
If any provision of this subtitle, an amendment made
by this subtitle, or the application of such provision or
amendment to any person or circumstance is held to be un-
constitutional, the remainder of this subtitle, the amend-
ments made by this subtitle, and the application of the pro-
visions of such to any person or circumstance shall not be
affected thereby.
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TITLE XXIII—WOMEN’S HEALTH
AND CANCER RIGHTS
SEC. 2301. WOMEN’S HEALTH AND CANCER RIGHTS.
(a) SHORT TITLE.—This section may be cited as the
‘‘Women’s Health and Cancer Rights Act of 2000’’.
(b) FINDINGS.—Congress finds that—
(1) the offering and operation of health plans af-
fect commerce among the States;
(2) health care providers located in a State serve
patients who reside in the State and patients who re-
side in other States; and
(3) in order to provide for uniform treatment of
health care providers and patients among the States,
it is necessary to cover health plans operating in 1
State as well as health plans operating among the
several States.
(c) AMENDMENTS TO ERISA.—
(1) IN GENERAL.—Subpart B of part 7 of sub-
title B of title I of the Employee Retirement Income
Security Act of 1974, as amended by section 2211(a),
is further amended by adding at the end the fol-
lowing:
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‘‘SEC. 715. REQUIRED COVERAGE FOR MINIMUM HOSPITAL
STAY FOR MASTECTOMIES AND LYMPH NODE
DISSECTIONS 
FOR 
THE 
TREATMENT 
OF
BREAST CANCER AND COVERAGE FOR SEC-
ONDARY CONSULTATIONS.
‘‘(a) INPATIENT CARE.—
‘‘(1) IN GENERAL.—A group health plan, and a
health insurance issuer providing health insurance
coverage in connection with a group health plan, 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 consulta-
tion with the patient, to be medically necessary and
appropriate following—
‘‘(A) a mastectomy;
‘‘(B) a lumpectomy; or
‘‘(C) a lymph node dissection for the treat-
ment of breast cancer.
‘‘(2) EXCEPTION.—Nothing in this section shall
be construed as requiring the provision of inpatient
coverage if the attending physician and patient deter-
mine that a shorter period of hospital stay is medi-
cally appropriate.
‘‘(b) PROHIBITION ON CERTAIN MODIFICATIONS.—In
implementing the requirements of this section, a group
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health plan, and a health insurance issuer providing health
insurance coverage in connection with a group health plan,
may not modify the terms and conditions of coverage based
on the determination by a participant or beneficiary to re-
quest less than the minimum coverage required under sub-
section (a).
‘‘(c) NOTICE.—A group health plan, and a health in-
surance issuer providing health insurance coverage in con-
nection with a group health plan shall provide notice to
each participant and beneficiary under such plan regarding
the coverage required by this section in accordance with reg-
ulations promulgated by the Secretary. Such notice shall
be in writing and prominently positioned in any literature
or correspondence made available or distributed by the plan
or issuer and shall be transmitted—
‘‘(1) in the next mailing made by the plan or
issuer to the participant or beneficiary;
‘‘(2) as part of any yearly informational packet
sent to the participant or beneficiary; or
‘‘(3) not later than January 1, 2001;
whichever is earlier.
‘‘(d) SECONDARY CONSULTATIONS.—
‘‘(1) IN GENERAL.—A group health plan, and a
health insurance issuer providing health insurance
coverage in connection with a group health plan, that
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provides coverage with respect to medical and sur-
gical 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 pathol-
ogy, radiology, and oncology) to confirm or refute
such diagnosis. Such plan or issuer shall ensure that
full coverage is provided for such secondary consulta-
tion whether such consultation is based on a positive
or negative initial diagnosis. In any case in which
the attending physician certifies in writing that serv-
ices necessary for such a secondary consultation are
not sufficiently available from specialists operating
under the plan 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.
‘‘(2) EXCEPTION.—Nothing in paragraph (1)
shall be construed as requiring the provision of sec-
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ondary consultations where the patient determines not
to seek such a consultation.
‘‘(e) PROHIBITION ON PENALTIES OR INCENTIVES.—
A group health plan, and a health insurance issuer pro-
viding health insurance coverage in connection with a
group health plan, may not—
‘‘(1) penalize or otherwise reduce or limit the re-
imbursement of a provider or specialist because the
provider or specialist provided care to a participant
or beneficiary in accordance with this section;
‘‘(2) provide financial or other incentives to a
physician or specialist to induce the physician or spe-
cialist to keep the length of inpatient stays of patients
following a mastectomy, lumpectomy, or a lymph
node dissection for the treatment of breast cancer
below certain limits or to limit referrals for secondary
consultations; or
‘‘(3) provide financial or other incentives to a
physician or specialist to induce the physician or spe-
cialist to refrain from referring a participant or bene-
ficiary for a secondary consultation that would other-
wise be covered by the plan or coverage involved
under subsection (d).’’.
(2) CLERICAL AMENDMENT.—The table of con-
tents in section 1 of the Employee Retirement Income
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Security Act of 1974 is amended by inserting after
the item relating to section 714 the following new
item:
‘‘Sec. 715. Required coverage for minimum hospital stay for mastectomies and
lymph node dissections for the treatment of breast cancer and
coverage for secondary consultations.’’.
(d) AMENDMENTS
TO PHSA RELATING
TO
THE
GROUP MARKET.—Subpart 2 of part A of title XXVII of
the Public Health Service Act (42 U.S.C. 300gg–4 et seq.)
is amended by adding at the end the following new section:
‘‘SEC. 2707. REQUIRED COVERAGE FOR MINIMUM HOSPITAL
STAY FOR MASTECTOMIES AND LYMPH NODE
DISSECTIONS 
FOR 
THE 
TREATMENT 
OF
BREAST CANCER AND COVERAGE FOR SEC-
ONDARY CONSULTATIONS.
‘‘(a) INPATIENT CARE.—
‘‘(1) IN GENERAL.—A group health plan, and a
health insurance issuer providing health insurance
coverage in connection with a group health plan, 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 consulta-
tion with the patient, to be medically necessary and
appropriate following—
‘‘(A) a mastectomy;
‘‘(B) a lumpectomy; or
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‘‘(C) a lymph node dissection for the treat-
ment of breast cancer.
‘‘(2) EXCEPTION.—Nothing in this section shall
be construed as requiring the provision of inpatient
coverage if the attending physician and patient deter-
mine that a shorter period of hospital stay is medi-
cally appropriate.
‘‘(b) PROHIBITION ON CERTAIN MODIFICATIONS.—In
implementing the requirements of this section, a group
health plan, and a health insurance issuer providing health
insurance coverage in connection with a group health plan,
may not modify the terms and conditions of coverage based
on the determination by a participant or beneficiary to re-
quest less than the minimum coverage required under sub-
section (a).
‘‘(c) NOTICE.—A group health plan, and a health in-
surance issuer providing health insurance coverage in con-
nection with a group health plan shall provide notice to
each participant and beneficiary under such plan regarding
the coverage required by this section in accordance with reg-
ulations promulgated by the Secretary. Such notice shall
be in writing and prominently positioned in any literature
or correspondence made available or distributed by the plan
or issuer and shall be transmitted—
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‘‘(1) in the next mailing made by the plan or
issuer to the participant or beneficiary;
‘‘(2) as part of any yearly informational packet
sent to the participant or beneficiary; or
‘‘(3) not later than January 1, 2001;
whichever is earlier.
‘‘(d) SECONDARY CONSULTATIONS.—
‘‘(1) IN GENERAL.—A group health plan, and a
health insurance issuer providing health insurance
coverage in connection with a group health plan that
provides coverage with respect to medical and sur-
gical 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 pathol-
ogy, radiology, and oncology) to confirm or refute
such diagnosis. Such plan or issuer shall ensure that
full coverage is provided for such secondary consulta-
tion whether such consultation is based on a positive
or negative initial diagnosis. In any case in which
the attending physician certifies in writing that serv-
ices necessary for such a secondary consultation are
not sufficiently available from specialists operating
under the plan with respect to whose services coverage
is otherwise provided under such plan or by such
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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.
‘‘(2) EXCEPTION.—Nothing in paragraph (1)
shall be construed as requiring the provision of sec-
ondary consultations where the patient determines not
to seek such a consultation.
‘‘(e) PROHIBITION ON PENALTIES OR INCENTIVES.—
A group health plan, and a health insurance issuer pro-
viding health insurance coverage in connection with a
group health plan, may not—
‘‘(1) penalize or otherwise reduce or limit the re-
imbursement of a provider or specialist because the
provider or specialist provided care to a participant
or beneficiary in accordance with this section;
‘‘(2) provide financial or other incentives to a
physician or specialist to induce the physician or spe-
cialist to keep the length of inpatient stays of patients
following a mastectomy, lumpectomy, or a lymph
node dissection for the treatment of breast cancer
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below certain limits or to limit referrals for secondary
consultations; or
‘‘(3) provide financial or other incentives to a
physician or specialist to induce the physician or spe-
cialist to refrain from referring a participant or bene-
ficiary for a secondary consultation that would other-
wise be covered by the plan or coverage involved
under subsection (d).’’.
(e) AMENDMENTS TO PHSA RELATING TO THE INDI-
VIDUAL MARKET.—The first subpart 3 of part B of title
XXVII of the Public Health Service Act (42 U.S.C. 300gg–
51 et seq.) (relating to other requirements) (42 U.S.C.
300gg–51 et seq.) is amended—
(1) by redesignating such subpart as subpart 2;
and
(2) by adding at the end the following:
‘‘SEC. 2753. REQUIRED COVERAGE FOR MINIMUM HOSPITAL
STAY FOR MASTECTOMIES AND LYMPH NODE
DISSECTIONS 
FOR 
THE 
TREATMENT 
OF
BREAST 
CANCER 
AND 
SECONDARY 
CON-
SULTATIONS.
‘‘The provisions of section 2707 shall apply to health
insurance coverage offered by a health insurance issuer in
the individual market in the same manner as they apply
to health insurance coverage offered by a health insurance
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issuer in connection with a group health plan in the small
or large group market.’’.
(f) AMENDMENTS TO THE IRC.—
(1) IN GENERAL.—Subchapter B of chapter 100
of the Internal Revenue Code of 1986, as amended by
section 2202, is further amended by inserting after
section 9813 the following:
‘‘SEC. 9814. REQUIRED COVERAGE FOR MINIMUM HOSPITAL
STAY FOR MASTECTOMIES AND LYMPH NODE
DISSECTIONS 
FOR 
THE 
TREATMENT 
OF
BREAST CANCER AND COVERAGE FOR SEC-
ONDARY CONSULTATIONS.
‘‘(a) INPATIENT CARE.—
‘‘(1) IN GENERAL.—A group health plan 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 consulta-
tion with the patient, to be medically necessary and
appropriate following—
‘‘(A) a mastectomy;
‘‘(B) a lumpectomy; or
‘‘(C) a lymph node dissection for the treat-
ment of breast cancer.
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‘‘(2) EXCEPTION.—Nothing in this section shall
be construed as requiring the provision of inpatient
coverage if the attending physician and patient deter-
mine that a shorter period of hospital stay is medi-
cally appropriate.
‘‘(b) PROHIBITION ON CERTAIN MODIFICATIONS.—In
implementing the requirements of this section, a group
health plan may not modify the terms and conditions of
coverage based on the determination by a participant or
beneficiary to request less than the minimum coverage re-
quired under subsection (a).
‘‘(c) NOTICE.—A group health plan shall provide no-
tice to each participant and beneficiary under such plan
regarding the coverage required by this section in accord-
ance with regulations promulgated by the Secretary. Such
notice shall be in writing and prominently positioned in
any literature or correspondence made available or distrib-
uted by the plan and shall be transmitted—
‘‘(1) in the next mailing made by the plan to the
participant or beneficiary;
‘‘(2) as part of any yearly informational packet
sent to the participant or beneficiary; or
‘‘(3) not later than January 1, 2000;
whichever is earlier.
‘‘(d) SECONDARY CONSULTATIONS.—
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‘‘(1) IN GENERAL.—A group health plan that
provides coverage with respect to medical and sur-
gical 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 pathol-
ogy, radiology, and oncology) to confirm or refute
such diagnosis. Such plan or issuer shall ensure that
full coverage is provided for such secondary consulta-
tion whether such consultation is based on a positive
or negative initial diagnosis. In any case in which
the attending physician certifies in writing that serv-
ices necessary for such a secondary consultation are
not sufficiently available from specialists operating
under the plan 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.
‘‘(2) EXCEPTION.—Nothing in paragraph (1)
shall be construed as requiring the provision of sec-
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ondary consultations where the patient determines not
to seek such a consultation.
‘‘(e) PROHIBITION ON PENALTIES.—A group health
plan may not—
‘‘(1) penalize or otherwise reduce or limit the re-
imbursement of a provider or specialist because the
provider or specialist provided care to a participant
or beneficiary in accordance with this section;
‘‘(2) provide financial or other incentives to a
physician or specialist to induce the physician or spe-
cialist to keep the length of inpatient stays of patients
following a mastectomy, lumpectomy, or a lymph
node dissection for the treatment of breast cancer
below certain limits or to limit referrals for secondary
consultations; or
‘‘(3) provide financial or other incentives to a
physician or specialist to induce the physician or spe-
cialist to refrain from referring a participant or bene-
ficiary for a secondary consultation that would other-
wise be covered by the plan involved under subsection
(d).’’.
(2) CLERICAL AMENDMENT.—The table of con-
tents for chapter 100 of such Code is amended by in-
serting after the item relating to section 9813 the fol-
lowing new item:
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‘‘Sec. 9814. Required coverage for minimum hospital stay for mastectomies and
lymph node dissections for the treatment of breast cancer and
coverage for secondary consultations.’’.
TITLE XXIV—GENETIC
INFORMATION AND SERVICES
SEC. 2401. SHORT TITLE.
This title may be cited as the ‘‘Genetic Information
Nondiscrimination in Health Insurance Act of 2000’’.
SEC. 2402. AMENDMENTS TO EMPLOYEE RETIREMENT IN-
COME SECURITY ACT OF 1974.
(a) PROHIBITION OF HEALTH DISCRIMINATION ON
THE BASIS OF GENETIC INFORMATION OR GENETIC SERV-
ICES.—
(1) NO ENROLLMENT RESTRICTION FOR GENETIC
SERVICES.—Section 702(a)(1)(F) of the Employee Re-
tirement Income Security Act of 1974 (29 U.S.C.
1182(a)(1)(F)) is amended by inserting before the pe-
riod the following: ‘‘(including information about a
request for or receipt of genetic services)’’.
(2) NO
DISCRIMINATION
IN
GROUP
PREMIUMS
BASED ON PREDICTIVE GENETIC INFORMATION.—Sub-
part B of part 7 of subtitle B of title I of the Em-
ployee Retirement Income Security Act of 1974, as
amended by section 2301(c), is further amended by
adding at the end the following: