I 
108TH CONGRESS 
1ST SESSION 
H. R. 597
To amend the Public Health Service Act, the Employee Retirement Income 
Security Act of 1974, and the Internal Revenue Code of 1986 to protect 
consumers in managed care plans and other health coverage. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 5, 2003
Mr. NORWOOD introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committees on 
Education and the Workforce, and Ways and Means, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
of such provisions as fall within the jurisdiction of the committee con-
cerned 
A BILL 
To amend the Public Health Service Act, the Employee Re-
tirement Income Security Act of 1974, and the Internal 
Revenue Code of 1986 to protect consumers in managed 
care plans and other health coverage.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Patient Protection Act’’.
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows:
Sec. 1. Short title; table of contents. 
TITLE I—IMPROVING MANAGED CARE 
Subtitle A—Utilization Review; Claims; and Internal and External Appeals 
Sec. 101. Utilization review activities. 
Sec. 102. Procedures for initial claims for benefits and prior authorization de-
terminations. 
Sec. 103. Internal appeals of claims denials. 
Sec. 104. Independent external appeals procedures. 
Sec. 105. Health care consumer assistance fund. 
Subtitle B—Access to Care 
Sec. 111. Consumer choice option. 
Sec. 112. Choice of health care professional. 
Sec. 113. Access to emergency care. 
Sec. 114. Timely access to specialists. 
Sec. 115. Patient access to obstetrical and gynecological care. 
Sec. 116. Access to pediatric care. 
Sec. 117. Continuity of care. 
Sec. 118. Access to needed prescription drugs. 
Sec. 119. Coverage for individuals participating in approved clinical trials. 
Sec. 120. Required coverage for minimum hospital stay for mastectomies and 
lymph node dissections for the treatment of breast cancer and 
coverage for secondary consultations. 
Subtitle C—Access to Information 
Sec. 121. Patient access to information. 
Subtitle D—Protecting the Doctor-Patient Relationship 
Sec. 131. Prohibition of interference with certain medical communications. 
Sec. 132. Prohibition of discrimination against providers based on licensure. 
Sec. 133. Prohibition against improper incentive arrangements. 
Sec. 134. Payment of claims. 
Sec. 135. Protection for patient advocacy. 
Subtitle E—Definitions 
Sec. 151. Definitions. 
Sec. 152. Preemption; State flexibility; construction. 
Sec. 153. Exclusions. 
Sec. 154. Treatment of excepted benefits. 
Sec. 155. Regulations. 
Sec. 156. Incorporation into plan or coverage documents.
Sec. 157. Preservation of protections. 
TITLE II—APPLICATION OF QUALITY CARE STANDARDS TO 
GROUP HEALTH PLANS AND HEALTH INSURANCE COVERAGE 
UNDER THE PUBLIC HEALTH SERVICE ACT 
Sec. 201. Application to group health plans and group health insurance cov-
erage. 
Sec. 202. Application to individual health insurance coverage. 
Sec. 203. Cooperation between Federal and State authorities. 
TITLE III—APPLICATION OF PATIENT PROTECTION STANDARDS 
TO FEDERAL HEALTH INSURANCE PROGRAMS 
Sec. 301. Application of patient protection standards to Federal health insur-
ance programs. 
TITLE IV—AMENDMENTS TO THE EMPLOYEE RETIREMENT 
INCOME SECURITY ACT OF 1974
Sec. 401. Application of patient protection standards to group health plans and 
group health insurance coverage under the Employee Retire-
ment Income Security Act of 1974. 
Sec. 402. Cooperation between Federal and State authorities. 
Sec. 403. Sense of the Congress concerning the importance of certain unpaid 
services. 
TITLE V—AMENDMENTS TO THE INTERNAL REVENUE CODE OF 
1986
Sec. 501. Application of requirements to group health plans under the Internal 
Revenue Code of 1986. 
Sec. 502. Conforming enforcement for women’s health and cancer rights. 
TITLE VI—EFFECTIVE DATES; COORDINATION IN 
IMPLEMENTATION 
Sec. 601. Effective dates. 
Sec. 602. Coordination in implementation. 
Sec. 603. Severability. 
TITLE VII—MISCELLANEOUS PROVISIONS 
Sec. 701. No impact on Social Security Trust Fund. 
Sec. 702. Sense of Congress with respect to participation in clinical trials and 
access to specialty care. 
Sec. 703. Sense of the Congress regarding fair review process. 
Sec. 704. Annual review.
TITLE I—IMPROVING MANAGED 
CARE 
Subtitle 
A—Utilization 
Review; 
Claims; and Internal and Exter-
nal Appeals 
SEC. 101. UTILIZATION REVIEW ACTIVITIES. 
(a) COMPLIANCE WITH REQUIREMENTS.—
(1) IN GENERAL.—A group health plan, and a 
health insurance issuer that provides health insur-
ance coverage, shall conduct utilization review activi-
ties in connection with the provision of benefits 
under such plan or coverage only in accordance with 
a utilization review program that meets the require-
ments of this section and section 102. 
(2) USE OF OUTSIDE AGENTS.—Nothing in this 
section shall be construed as preventing a group 
health plan or health insurance issuer from arrang-
ing through a contract or otherwise for persons or 
entities to conduct utilization review activities on be-
half of the plan or issuer, so long as such activities 
are conducted in accordance with a utilization review 
program that meets the requirements of this section. 
(3) UTILIZATION REVIEW DEFINED.—For pur-
poses of this section, the terms ‘‘utilization review’’ 
and ‘‘utilization review activities’’ mean procedures
used to monitor or evaluate the use or coverage, 
clinical necessity, appropriateness, efficacy, or effi-
ciency of health care services, procedures or settings, 
and includes prospective review, concurrent review, 
second opinions, case management, discharge plan-
ning, or retrospective review. 
(b) WRITTEN POLICIES AND CRITERIA.—
(1) WRITTEN POLICIES.—A utilization review 
program shall be conducted consistent with written 
policies and procedures that govern all aspects of the 
program. 
(2) USE OF WRITTEN CRITERIA.—
(A) IN GENERAL.—Such a program shall 
utilize written clinical review criteria developed 
with input from a range of appropriate actively 
practicing health care professionals, as deter-
mined by the plan, pursuant to the program. 
Such criteria shall include written clinical re-
view criteria that are based on valid clinical evi-
dence where available and that are directed spe-
cifically at meeting the needs of at-risk popu-
lations and covered individuals with chronic 
conditions or severe illnesses, including gender-
specific criteria and pediatric-specific criteria 
where available and appropriate.
(B) CONTINUING USE OF STANDARDS IN 
RETROSPECTIVE
REVIEW.—If a health care 
service has been specifically pre-authorized or 
approved for a participant, beneficiary, or en-
rollee under such a program, the program shall 
not, pursuant to retrospective review, revise or 
modify the specific standards, criteria, or proce-
dures used for the utilization review for proce-
dures, treatment, and services delivered to the 
enrollee during the same course of treatment. 
(C) REVIEW OF SAMPLE OF CLAIMS DENI-
ALS.—Such a program shall provide for a peri-
odic evaluation of the clinical appropriateness of 
at least a sample of denials of claims for bene-
fits. 
(c) CONDUCT OF PROGRAM ACTIVITIES.—
(1) ADMINISTRATION BY HEALTH CARE PRO-
FESSIONALS.—A utilization review program shall be 
administered by qualified health care professionals 
who shall oversee review decisions. 
(2) USE
OF
QUALIFIED, INDEPENDENT
PER-
SONNEL.—
(A) IN
GENERAL.—A utilization review 
program shall provide for the conduct of utiliza-
tion review activities only through personnel
who are qualified and have received appropriate 
training in the conduct of such activities under 
the program. 
(B) PROHIBITION
OF
CONTINGENT
COM-
PENSATION ARRANGEMENTS.—Such a program 
shall not, with respect to utilization review ac-
tivities, permit or provide compensation or any-
thing of value to its employees, agents, or con-
tractors in a manner that encourages denials of 
claims for benefits. 
(C) PROHIBITION OF CONFLICTS.—Such a 
program shall not permit a health care profes-
sional who is providing health care services to 
an individual to perform utilization review ac-
tivities in connection with the health care serv-
ices being provided to the individual. 
(3) ACCESSIBILITY OF REVIEW.—Such a pro-
gram shall provide that appropriate personnel per-
forming utilization review activities under the pro-
gram, including the utilization review administrator, 
are reasonably accessible by toll-free telephone dur-
ing normal business hours to discuss patient care 
and allow response to telephone requests, and that 
appropriate provision is made to receive and respond 
promptly to calls received during other hours.
(4) LIMITS ON FREQUENCY.—Such a program 
shall not provide for the performance of utilization 
review activities with respect to a class of services 
furnished to an individual more frequently than is 
reasonably required to assess whether the services 
under review are medically necessary and appro-
priate. 
SEC. 102. PROCEDURES FOR INITIAL CLAIMS FOR BENE-
FITS AND PRIOR AUTHORIZATION DETER-
MINATIONS. 
(a) PROCEDURES OF INITIAL CLAIMS FOR BENE-
FITS.—
(1) IN GENERAL.—A group health plan, and a 
health insurance issuer offering health insurance 
coverage, shall—
(A) make a determination on an initial 
claim for benefits by a participant, beneficiary, 
or enrollee (or authorized representative) re-
garding payment or coverage for items or serv-
ices under the terms and conditions of the plan 
or coverage involved, including any cost-sharing 
amount that the participant, beneficiary, or en-
rollee is required to pay with respect to such 
claim for benefits; and
(B) notify a participant, beneficiary, or en-
rollee (or authorized representative) and the 
treating health care professional involved re-
garding a determination on an initial claim for 
benefits made under the terms and conditions 
of the plan or coverage, including any cost-shar-
ing amounts that the participant, beneficiary, 
or enrollee may be required to make with re-
spect to such claim for benefits, and of the 
right of the participant, beneficiary, or enrollee 
to an internal appeal under section 103. 
(2) ACCESS TO INFORMATION.—
(A) TIMELY PROVISION OF NECESSARY IN-
FORMATION.—With respect to an initial claim 
for benefits, the participant, beneficiary, or en-
rollee (or authorized representative) and the 
treating health care professional (if any) shall 
provide the plan or issuer with access to infor-
mation requested by the plan or issuer that is 
necessary to make a determination relating to 
the claim. Such access shall be provided not 
later than 5 days after the date on which the 
request for information is received, or, in a case 
described in subparagraph (B) or (C) of sub-
section (b)(1), by such earlier time as may be
necessary to comply with the applicable timeline 
under such subparagraph. 
(B) LIMITED
EFFECT
OF
FAILURE
ON 
PLAN
OR
ISSUER’S
OBLIGATIONS.—Failure of 
the participant, beneficiary, or enrollee to com-
ply with the requirements of subparagraph (A) 
shall not remove the obligation of the plan or 
issuer to make a decision in accordance with 
the medical exigencies of the case and as soon
as possible, based on the available information, 
and failure to comply with the time limit estab-
lished by this paragraph shall not remove the 
obligation of the plan or issuer to comply with 
the requirements of this section. 
(3) ORAL REQUESTS.—In the case of a claim 
for benefits involving an expedited or concurrent de-
termination, a participant, beneficiary, or enrollee 
(or authorized representative) may make an initial 
claim for benefits orally, but a group health plan, or 
health insurance issuer offering health insurance 
coverage, may require that the participant, bene-
ficiary, or enrollee (or authorized representative) 
provide written confirmation of such request in a 
timely manner on a form provided by the plan or 
issuer. In the case of such an oral request for bene-
fits, the making of the request (and the timing of 
such request) shall be treated as the making at that 
time of a claim for such benefits without regard to 
whether and when a written confirmation of such re-
quest is made. 
(b) TIMELINE FOR MAKING DETERMINATIONS.—
(1) PRIOR AUTHORIZATION DETERMINATION.—
(A) IN GENERAL.—A group health plan, 
and a health insurance issuer offering health in-
surance coverage, shall make a prior authoriza-
tion determination on a claim for benefits 
(whether oral or written) in accordance with the 
medical exigencies of the case and as soon as 
possible, but in no case later than 14 days from 
the date on which the plan or issuer receives in-
formation that is reasonably necessary to enable 
the plan or issuer to make a determination on 
the request for prior authorization and in no 
case later than 28 days after the date of the 
claim for benefits is received. 
(B) EXPEDITED
DETERMINATION.—Not-
withstanding subparagraph (A), a group health 
plan, and a health insurance issuer offering 
health insurance coverage, shall expedite a prior 
authorization determination on a claim for ben-
efits described in such subparagraph when a re-
quest for such an expedited determination is 
made by a participant, beneficiary, or enrollee 
(or authorized representative) at any time dur-
ing the process for making a determination and 
a health care professional certifies, with the re-
quest, that a determination under the proce-
dures described in subparagraph (A) would seri-
ously jeopardize the life or health of the partici-
pant, beneficiary, or enrollee or the ability of 
the participant, beneficiary, or enrollee to main-
tain or regain maximum function. Such deter-
mination shall be made in accordance with the 
medical exigencies of the case and as soon as 
possible, but in no case later than 72 hours 
after the time the request is received by the 
plan or issuer under this subparagraph. 
(C) ONGOING CARE.—
(i) CONCURRENT REVIEW.—
(I) IN
GENERAL.—Subject to 
clause (ii), in the case of a concurrent 
review of ongoing care (including hos-
pitalization), which results in a termi-
nation or reduction of such care, the 
plan or issuer must provide by tele-
phone and in printed form notice of 
the concurrent review determination 
to the individual or the individual’s 
designee and the individual’s health 
care provider in accordance with the 
medical exigencies of the case and as 
soon as possible, with sufficient time 
prior to the termination or reduction 
to allow for an appeal under section 
103(b)(3) to be completed before the 
termination or reduction takes effect. 
(II) CONTENTS
OF
NOTICE.—
Such notice shall include, with respect 
to ongoing health care items and serv-
ices, the number of ongoing services 
approved, the new total of approved 
services, the date of onset of services, 
and the next review date, if any, as 
well as a statement of the individual’s 
rights to further appeal. 
(ii) RULE OF CONSTRUCTION.—Clause 
(i) shall not be construed as requiring 
plans or issuers to provide coverage of care 
that would exceed the coverage limitations 
for such care.
(2) 
RETROSPECTIVE
DETERMINATION.—A 
group health plan, and a health insurance issuer of-
fering health insurance coverage, shall make a retro-
spective determination on a claim for benefits in ac-
cordance with the medical exigencies of the case and 
as soon as possible, but not later than 30 days after 
the date on which the plan or issuer receives infor-
mation that is reasonably necessary to enable the 
plan or issuer to make a determination on the claim, 
or, if earlier, 60 days after the date of receipt of the 
claim for benefits. 
(c) NOTICE OF A DENIAL OF A CLAIM FOR BENE-
FITS.—Written notice of a denial made under an initial 
claim for benefits shall be issued to the participant, bene-
ficiary, or enrollee (or authorized representative) and the 
treating health care professional in accordance with the 
medical exigencies of the case and as soon as possible, but 
in no case later than 2 days after the date of the deter-
mination (or, in the case described in subparagraph (B) 
or (C) of subsection (b)(1), within the 72-hour or applica-
ble period referred to in such subparagraph). 
(d) REQUIREMENTS
OF NOTICE
OF DETERMINA-
TIONS.—The written notice of a denial of a claim for bene-
fits determination under subsection (c) shall be provided 
in printed form and written in a manner calculated to be
understood by the participant, beneficiary, or enrollee and 
shall include—
(1) the specific reasons for the determination 
(including a summary of the clinical or scientific evi-
dence used in making the determination); 
(2) the procedures for obtaining additional in-
formation concerning the determination; and
(3) notification of the right to appeal the deter-
mination and instructions on how to initiate an ap-
peal in accordance with section 103. 
(e) DEFINITIONS.—For purposes of this part: 
(1) AUTHORIZED REPRESENTATIVE.—The term 
‘‘authorized representative’’ means, with respect to 
an individual who is a participant, beneficiary, or en-
rollee, any health care professional or other person 
acting on behalf of the individual with the individ-
ual’s consent or without such consent if the indi-
vidual is medically unable to provide such consent. 
(2) CLAIM FOR BENEFITS.—The term ‘‘claim 
for benefits’’ means any request for coverage (in-
cluding authorization of coverage), for eligibility, or 
for payment in whole or in part, for an item or serv-
ice under a group health plan or health insurance 
coverage.
(3) DENIAL
OF
CLAIM
FOR
BENEFITS.—The 
term ‘‘denial’’ means, with respect to a claim for 
benefits, a denial (in whole or in part) of, or a fail-
ure to act on a timely basis upon, the claim for ben-
efits and includes a failure to provide benefits (in-
cluding items and services) required to be provided 
under this title. 
(4) TREATING HEALTH CARE PROFESSIONAL.—
The term ‘‘treating health care professional’’ means, 
with respect to services to be provided to a partici-
pant, beneficiary, or enrollee, a health care profes-
sional who is primarily responsible for delivering 
those services to the participant, beneficiary, or en-
rollee. 
SEC. 103. INTERNAL APPEALS OF CLAIMS DENIALS. 
(a) RIGHT TO INTERNAL APPEAL.—
(1) IN GENERAL.—A participant, beneficiary, or 
enrollee (or authorized representative) may appeal 
any denial of a claim for benefits under section 102 
under the procedures described in this section. 
(2) TIME FOR APPEAL.—
(A) IN GENERAL.—A group health plan, 
and a health insurance issuer offering health in-
surance coverage, shall ensure that a partici-
pant, beneficiary, or enrollee (or authorized rep-
resentative) has a period of not less than 180 
days beginning on the date of a denial of a 
claim for benefits under section 102 in which to 
appeal such denial under this section. 
(B) DATE OF DENIAL.—For purposes of 
subparagraph (A), the date of the denial shall 
be deemed to be the date as of which the partic-
ipant, beneficiary, or enrollee knew of the denial 
of the claim for benefits. 
(3) FAILURE TO ACT.—The failure of a plan or 
issuer to issue a determination on a claim for bene-
fits under section 102 within the applicable timeline 
established for such a determination under such sec-
tion is a denial of a claim for benefits for purposes 
this subtitle as of the date of the applicable deadline. 
(4) PLAN WAIVER OF INTERNAL REVIEW.—A 
group health plan, or health insurance issuer offer-
ing health insurance coverage, may waive the inter-
nal review process under this section. In such case 
the plan or issuer shall provide notice to the partici-
pant, beneficiary, or enrollee (or authorized rep-
resentative) involved, the participant, beneficiary, or 
enrollee (or authorized representative) involved shall 
be relieved of any obligation to complete the internal 
review involved, and may, at the option of such par-
ticipant, beneficiary, enrollee, or representative pro-
ceed directly to seek further appeal through external 
review under section 104 or otherwise. 
(b) TIMELINES FOR MAKING DETERMINATIONS.—
(1) ORAL REQUESTS.—In the case of an appeal 
of a denial of a claim for benefits under this section 
that involves an expedited or concurrent determina-
tion, a participant, beneficiary, or enrollee (or au-
thorized representative) may request such appeal 
orally. A group health plan, or health insurance 
issuer offering health insurance coverage, may re-
quire that the participant, beneficiary, or enrollee 
(or authorized representative) provide written con-
firmation of such request in a timely manner on a 
form provided by the plan or issuer. In the case of 
such an oral request for an appeal of a denial, the 
making of the request (and the timing of such re-
quest) shall be treated as the making at that time 
of a request for an appeal without regard to whether 
and when a written confirmation of such request is 
made. 
(2) ACCESS TO INFORMATION.—
(A) TIMELY PROVISION OF NECESSARY IN-
FORMATION.—With respect to an appeal of a 
denial of a claim for benefits, the participant,
beneficiary, or enrollee (or authorized represent-
ative) and the treating health care professional 
(if any) shall provide the plan or issuer with 
access to information requested by the plan or 
issuer that is necessary to make a determina-
tion relating to the appeal. Such access shall 
be provided not later than 5 days after the date 
on which the request for information is re-
ceived, or, in a case described in subparagraph 
(B) or (C) of paragraph (3), by such earlier 
time as may be necessary to comply with the 
applicable timeline under such subparagraph. 
(B) LIMITED
EFFECT
OF
FAILURE
ON 
PLAN
OR
ISSUER’S
OBLIGATIONS.—Failure of 
the participant, beneficiary, or enrollee to com-
ply with the requirements of subparagraph (A) 
shall not remove the obligation of the plan or 
issuer to make a decision in accordance with 
the medical exigencies of the case and as soon 
as possible, based on the available information, 
and failure to comply with the time limit estab-
lished by this paragraph shall not remove the 
obligation of the plan or issuer to comply with 
the requirements of this section.
(3) 
PRIOR
AUTHORIZATION
DETERMINA-
TIONS.—
(A) IN GENERAL.—Except as provided in 
this paragraph or paragraph (4), a group 
health plan, and a health insurance issuer offer-
ing health insurance coverage, shall make a de-
termination on an appeal of a denial of a claim 
for benefits under this subsection in accordance
with the medical exigencies of the case and as 
soon as possible, but in no case later than 14 
days from the date on which the plan or issuer 
receives information that is reasonably nec-
essary to enable the plan or issuer to make a 
determination on the appeal and in no case 
later than 28 days after the date the request 
for the appeal is received. 
(B) EXPEDITED
DETERMINATION.—Not-
withstanding subparagraph (A), a group health 
plan, and a health insurance issuer offering 
health insurance coverage, shall expedite a prior 
authorization determination on an appeal of a 
denial of a claim for benefits described in sub-
paragraph (A), when a request for such an ex-
pedited determination is made by a participant, 
beneficiary, or enrollee (or authorized represent-
ative) at any time during the process for mak-
ing a determination and a health care profes-
sional certifies, with the request, that a deter-
mination under the procedures described in sub-
paragraph (A) would seriously jeopardize the 
life or health of the participant, beneficiary, or 
enrollee or the ability of the participant, bene-
ficiary, or enrollee to maintain or regain max-
imum function. Such determination shall be 
made in accordance with the medical exigencies 
of the case and as soon as possible, but in no 
case later than 72 hours after the time the re-
quest for such appeal is received by the plan or 
issuer under this subparagraph. 
(C) ONGOING CARE DETERMINATIONS.—
(i) IN
GENERAL.—Subject to clause 
(ii), in the case of a concurrent review de-
termination 
described 
in 
section 
102(b)(1)(C)(i)(I), which results in a ter-
mination or reduction of such care, the 
plan or issuer must provide notice of the 
determination on the appeal under this 
section by telephone and in printed form to 
the individual or the individual’s designee 
and the individual’s health care provider in
accordance with the medical exigencies of 
the case and as soon as possible, with suf-
ficient time prior to the termination or re-
duction to allow for an external appeal 
under section 104 to be completed before 
the termination or reduction takes effect. 
(ii) RULE OF CONSTRUCTION.—Clause 
(i) shall not be construed as requiring 
plans or issuers to provide coverage of care 
that would exceed the coverage limitations 
for such care. 
(4) 
RETROSPECTIVE
DETERMINATION.—A 
group health plan, and a health insurance issuer of-
fering health insurance coverage, shall make a retro-
spective determination on an appeal of a denial of a 
claim for benefits in no case later than 30 days after 
the date on which the plan or issuer receives nec-
essary information that is reasonably necessary to 
enable the plan or issuer to make a determination on 
the appeal and in no case later than 60 days after 
the date the request for the appeal is received. 
(c) CONDUCT OF REVIEW.—
(1) IN GENERAL.—A review of a denial of a 
claim for benefits under this section shall be con-
ducted by an individual with appropriate expertise 
who was not involved in the initial determination. 
(2) PEER REVIEW OF MEDICAL DECISIONS BY 
HEALTH CARE PROFESSIONALS.—A review of an ap-
peal 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 treat-
ment, or requires an evaluation of medical facts—
(A) 
shall 
be 
made 
by 
a 
physician 
(allopathic or osteopathic); or 
(B) in a claim for benefits provided by a 
non-physician health professional, shall be made 
by a review panel including at least one prac-
ticing non-physician health professional of the 
same or similar specialty; 
with appropriate expertise (including, in the case of 
a child, appropriate pediatric expertise) and acting 
within the appropriate scope of practice within the 
State in which the service is provided or rendered, 
who was not involved in the initial determination. 
(d) NOTICE OF DETERMINATION.—
(1) IN GENERAL.—Written notice of a deter-
mination made under an internal appeal of a denial 
of a claim for benefits shall be issued to the partici-
pant, beneficiary, or enrollee (or authorized rep-
resentative) and the treating health care professional 
in accordance with the medical exigencies of the case 
and as soon as possible, but in no case later than 
2 days after the date of completion of the review (or, 
in the case described in subparagraph (B) or (C) of 
subsection (b)(3), within the 72-hour or applicable 
period referred to in such subparagraph). 
(2) FINAL DETERMINATION.—The decision by a 
plan or issuer under this section shall be treated as 
the final determination of the plan or issuer on a de-
nial of a claim for benefits. The failure of a plan or 
issuer to issue a determination on an appeal of a de-
nial of a claim for benefits under this section within 
the applicable timeline established for such a deter-
mination shall be treated as a final determination on 
an appeal of a denial of a claim for benefits for pur-
poses of proceeding to external review under section 
104. 
(3) REQUIREMENTS OF NOTICE.—With respect 
to a determination made under this section, the no-
tice described in paragraph (1) shall be provided in 
printed form and written in a manner calculated to 
be understood by the participant, beneficiary, or en-
rollee and shall include—
(A) the specific reasons for the determina-
tion (including a summary of the clinical or sci-
entific evidence used in making the determina-
tion); 
(B) the procedures for obtaining additional 
information concerning the determination; and 
(C) notification of the right to an inde-
pendent external review under section 104 and 
instructions on how to initiate such a review. 
SEC. 104. INDEPENDENT EXTERNAL APPEALS PROCE-
DURES. 
(a) RIGHT TO EXTERNAL APPEAL.—A group health 
plan, and a health insurance issuer offering health insur-
ance coverage, shall provide in accordance with this sec-
tion participants, beneficiaries, and enrollees (or author-
ized representatives) with access to an independent exter-
nal 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 180 days 
after the date on which the participant, beneficiary, 
or enrollee receives notice of the denial under section 
103(d) or notice of waiver of internal review under
section 103(a)(4) or the date on which the plan or 
issuer has failed to make a timely decision under 
section 103(d)(2) and notifies the participant or 
beneficiary that it has failed to make a timely deci-
sion and that the beneficiary must file an appeal 
with an external review entity within 180 days if the
participant or beneficiary desires to file such an ap-
peal. 
(2) FILING OF REQUEST.—
(A) IN
GENERAL.—Subject to the suc-
ceeding provisions of this subsection, a group 
health plan, or health insurance issuer offering 
health insurance coverage, may—
(i) except as provided in subparagraph 
(B)(i), require that a request for review be 
in writing; 
(ii) limit the filing of such a request 
to the participant, beneficiary, or enrollee 
involved (or an authorized representative); 
(iii) except if waived by the plan or 
issuer under section 103(a)(4), condition 
access to an independent external review 
under this section upon a final determina-
tion of a denial of a claim for benefits
under the internal review procedure under 
section 103; 
(iv) except as provided in subpara-
graph (B)(ii), require payment of a filing 
fee to the plan or issuer of a sum that does 
not exceed $25; and 
(v) require that a request for review 
include the consent of the participant, ben-
eficiary, or enrollee (or authorized rep-
resentative) for the release of necessary 
medical information or records of the par-
ticipant, beneficiary, or enrollee to the 
qualified external review entity only for 
purposes of conducting external review ac-
tivities. 
(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 ex-
ternal review as provided for under sub-
section (e), the request for such review 
may be made orally. A group health plan, 
or health insurance issuer offering health 
insurance coverage, may require that the
participant, beneficiary, or enrollee (or au-
thorized representative) provide written 
confirmation of such request in a timely 
manner on a form provided by the plan or 
issuer. Such written confirmation shall be 
treated as a consent for purposes of sub-
paragraph (A)(v). In the case of such an 
oral request for such a review, the making 
of the request (and the timing of such re-
quest) shall be treated as the making at 
that time of a request for such a review 
without regard to whether and when a 
written confirmation of such request is 
made. 
(ii) EXCEPTION TO FILING FEE RE-
QUIREMENT.—
(I) INDIGENCY.—Payment of a 
filing fee shall not be required under 
subparagraph (A)(iv) where there is a 
certification (in a form and manner 
specified in guidelines established by 
the appropriate Secretary) that the 
participant, beneficiary, or enrollee is 
indigent (as defined in such guide-
lines).
(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 
103(a)(4). 
(III) REFUNDING OF FEE.—The 
filing fee paid under subparagraph 
(A)(iv) shall be refunded if the deter-
mination under the independent exter-
nal review is to reverse the denial 
which is the subject of the review. 
(IV) COLLECTION
OF
FILING 
FEE.—The failure to pay such a filing 
fee shall not prevent the consideration 
of a request for review but, subject to 
the preceding provisions of this clause, 
shall constitute a legal liability to pay. 
(c) REFERRAL TO QUALIFIED EXTERNAL REVIEW 
ENTITY UPON REQUEST.—
(1) IN GENERAL.—Upon the filing of a request 
for independent external review with the group 
health plan, or health insurance issuer offering 
health insurance coverage, the plan or issuer shall 
immediately refer such request, and forward the
plan or issuer’s initial decision (including the infor-
mation described in section 103(d)(3)(A)), to a 
qualified external review entity selected in accord-
ance with this section. 
(2) ACCESS TO PLAN OR ISSUER AND HEALTH 
PROFESSIONAL INFORMATION.—With respect to an 
independent external review conducted under this 
section, the participant, beneficiary, or enrollee (or 
authorized representative), the plan or issuer, and 
the treating health care professional (if any) shall 
provide the external review entity with information 
that is necessary to conduct a review under this sec-
tion, as determined and requested by the entity. 
Such information shall be provided not later than 5 
days after the date on which the request for infor-
mation is received, or, in a case described in clause 
(ii) or (iii) of subsection (e)(1)(A), by such earlier 
time as may be necessary to comply with the appli-
cable timeline under such clause. 
(3) SCREENING OF REQUESTS BY QUALIFIED 
EXTERNAL REVIEW ENTITIES.—
(A) IN GENERAL.—With respect to a re-
quest referred to a qualified external review en-
tity 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 
clauses (ii) or (iii) of subsection (b)(2)(A) 
have not been met;
(ii) the denial of the claim for benefits 
does not involve a medically reviewable de-
cision under subsection (d)(2); 
(iii) the denial of the claim for bene-
fits relates to a decision regarding whether 
an individual is a participant, beneficiary, 
or enrollee who is enrolled under the terms 
and conditions of the plan or coverage (in-
cluding the applicability of any waiting pe-
riod under the plan or coverage); or 
(iv) the denial of the claim for bene-
fits is a decision as to the application of 
cost-sharing requirements or the applica-
tion of a specific exclusion or express limi-
tation on the amount, duration, or scope of 
coverage of items or services under the 
terms and conditions of the plan or cov-
erage unless the decision is a denial de-
scribed in subsection (d)(2).
Upon making a determination that any of 
clauses (i) through (iv) applies with respect to 
the request, the entity shall determine that the 
denial of a claim for benefits involved is not eli-
gible for independent medical review under sub-
section (d), and shall provide notice in accord-
ance with subparagraph (C). 
(B) 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 or the recommendation 
of a treating health care professional (if 
any). 
(ii) 
USE
OF
APPROPRIATE
PER-
SONNEL.—A qualified external review enti-
ty shall use appropriately qualified per-
sonnel to make determinations under this 
section. 
(C) NOTICES
AND
GENERAL
TIMELINES 
FOR DETERMINATION.—
(i) NOTICE IN CASE OF DENIAL OF 
REFERRAL.—If the entity under this para-
graph does not make a referral to an inde-
pendent medical review panel, the entity 
shall provide notice to the plan or issuer, 
the participant, beneficiary, or enrollee (or 
authorized representative) filing the re-
quest, and the treating health care profes-
sional (if any) that the denial is not sub-
ject to independent medical review. Such 
notice—
(I) shall be written (and, in addi-
tion, may be provided orally) in a 
manner calculated to be understood 
by a participant or enrollee; 
(II) shall include the reasons for 
the determination; 
(III) include any relevant terms 
and conditions of the plan or cov-
erage; and 
(IV) include a description of any 
further recourse available to the indi-
vidual. 
(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 review panel, shall make a 
determination within the overall timeline 
that is applicable to the case under review 
as described in subsection (e), except that 
if the entity determines that a referral to 
an independent medical review panel is not 
required, the entity shall provide notice of 
such determination to the participant, ben-
eficiary, or enrollee (or authorized rep-
resentative) within such timeline and with-
in 2 days of the date of such determina-
tion. 
(d) INDEPENDENT MEDICAL REVIEW.—
(1) IN GENERAL.—If a qualified external review 
entity determines under subsection (c) that a denial 
of a claim for benefits is eligible for independent 
medical review, the entity shall refer the denial in-
volved to an independent medical reviewer for the 
conduct of an independent medical review under this 
subsection. 
(2) MEDICALLY
REVIEWABLE
DECISIONS.—A 
denial of a claim for benefits is eligible for inde-
pendent medical review if the benefit for the item or 
service for which the claim is made would be a cov-
ered benefit under the terms and conditions of the
plan or coverage but for one (or more) of the fol-
lowing determinations: 
(A) DENIALS BASED ON MEDICAL NECES-
SITY AND APPROPRIATENESS.—A determination 
that the item or service is not covered because 
it is not medically necessary and appropriate or 
based on the application of substantially equiva-
lent terms. 
(B) DENIALS
BASED
ON
EXPERIMENTAL 
OR
INVESTIGATIONAL
TREATMENT.—A deter-
mination that the item or service is not covered 
because it is experimental or investigational or 
based on the application of substantially equiva-
lent terms. 
(C) DENIALS OTHERWISE BASED ON AN 
EVALUATION
OF
MEDICAL
FACTS.—A deter-
mination that the item or service or condition 
is not covered based on grounds that require an 
evaluation of the medical facts by a health care 
professional in the specific case involved to de-
termine the coverage and extent of coverage of 
the item or service or condition. 
(3) INDEPENDENT
MEDICAL
REVIEW
DETER-
MINATION.—
(A) IN GENERAL.—An independent med-
ical review panel under this section shall make 
a new independent determination with respect 
to whether or not the denial of a claim for a 
benefit that is the subject of the review should 
be upheld or reversed.
(B) STANDARD
FOR
DETERMINATION.—
The independent medical review panel’s deter-
mination relating to the medical necessity and 
appropriateness, or the experimental or inves-
tigational nature, or the evaluation of the med-
ical facts, of the item, service, or condition in-
volved shall be based on the medical condition 
of the participant, beneficiary, or enrollee (in-
cluding the medical records of the participant, 
beneficiary, or enrollee) and valid, relevant sci-
entific evidence and clinical evidence, including 
peer-reviewed medical literature or findings and 
including expert opinion. 
(C) NO COVERAGE FOR EXCLUDED BENE-
FITS.—Nothing in this subsection shall be con-
strued to permit an independent medical review 
panel to require that a group health plan, or 
health insurance issuer offering health insur-
ance coverage, provide coverage for items or
services for which benefits are specifically ex-
cluded or expressly limited under the plan or 
coverage in the plain language of the plan docu-
ment (and which are disclosed under section 
121(b)(1)(C)). Notwithstanding any other pro-
vision of this Act, any exclusion of an exact 
medical procedure, any exact time limit on the 
duration or frequency of coverage, and any 
exact dollar limit on the amount of coverage 
that is specifically enumerated and defined (in 
the plain language of the plan or coverage docu-
ments) under the plan or coverage offered by a 
group health plan or health insurance issuer of-
fering health insurance coverage and that is 
disclosed under section 121(b)(1) shall be con-
sidered to govern the scope of the benefits that 
may be required: Provided, That the terms and 
conditions of the plan or coverage relating to 
such an exclusion or limit are in compliance 
with the requirements of law. 
(D) EVIDENCE AND INFORMATION TO BE 
USED IN MEDICAL REVIEWS.—In making a de-
termination under this subsection, the inde-
pendent medical review panel shall also consider
appropriate and available evidence and informa-
tion, including the following: 
(i) The determination made by the 
plan or issuer with respect to the claim 
upon internal review and the evidence, 
guidelines, or rationale used by the plan or 
issuer in reaching such determination. 
(ii) The recommendation of the 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 relevant evidence or 
information obtained by the review panel 
or submitted by the plan, issuer, partici-
pant, beneficiary, or enrollee (or an au-
thorized representative), or treating health 
care professional. 
(iv) The plan or coverage document. 
(E) INDEPENDENT
DETERMINATION.—In 
making determinations under this section, a 
qualified external review entity and an inde-
pendent medical review panel shall—
(i) consider the claim under review 
without deference to the determinations
made by the plan or issuer or the rec-
ommendation of the treating health care 
professional (if any); and 
(ii) consider, but not be bound by, the 
definition used by the plan or issuer of 
‘‘medically necessary and appropriate’’, or 
‘‘experimental or investigational’’, or other 
substantially equivalent terms that are 
used by the plan or issuer to describe med-
ical necessity and appropriateness or ex-
perimental or investigational nature of the 
treatment. 
(F) DETERMINATION
OF
INDEPENDENT 
MEDICAL
REVIEW
PANEL.—An independent 
medical review panel shall, in accordance with 
the deadlines described in subsection (e), pre-
pare a written determination to uphold or re-
verse the denial under review. Such written de-
termination shall include—
(i) the determination of the review 
panel; 
(ii) the specific reasons of the review 
panel for such determination, including a 
summary of the clinical or scientific evi-
dence used in making the determination; 
and 
(iii) with respect to a determination to 
reverse the denial under review, a time-
frame within which the plan or issuer must 
comply with such determination. 
(G) NONBINDING NATURE OF ADDITIONAL 
RECOMMENDATIONS.—In addition to the deter-
mination under subparagraph (F), the review 
panel may provide the plan or issuer and the 
treating health care professional with additional 
recommendations in connection with such a de-
termination, but any such recommendations 
shall not affect (or be treated as part of) the 
determination and shall not be binding on the 
plan or issuer. 
(e) TIMELINES AND NOTIFICATIONS.—
(1) TIMELINES
FOR
INDEPENDENT
MEDICAL 
REVIEW.—
(A) PRIOR
AUTHORIZATION
DETERMINA-
TION.—
(i) IN
GENERAL.—The independent 
medical review panel shall make a deter-
mination on a denial of a claim for benefits 
that is referred to the review panel under
subsection (c)(3) in accordance with the 
medical exigencies of the case and as soon 
as possible, but in no case later than 14 
days after the date of receipt of informa-
tion under subsection (c)(2) if the review 
involves a prior authorization of items or 
services and in no case later than 21 days
after the date the request for external re-
view is received. 
(ii) EXPEDITED
DETERMINATION.—
Notwithstanding clause (i) and subject to 
clause (iii), the independent medical review 
panel shall make an expedited determina-
tion on a denial of a claim for benefits de-
scribed in clause (i), when a request for 
such an expedited determination is made 
by a participant, beneficiary, or enrollee 
(or authorized representative) at any time 
during the process for making a deter-
mination, and a health care professional 
certifies, with the request, that a deter-
mination under the timeline described in 
clause (i) would seriously jeopardize the 
life or health of the participant, bene-
ficiary, or enrollee or the ability of the par-
ticipant, beneficiary, or enrollee to main-
tain or regain maximum function. Such de-
termination shall be made in accordance 
with the medical exigencies of the case and 
as soon as possible, but in no case later 
than 72 hours after the time the request 
for external review is received by the quali-
fied external review entity. 
(iii) 
ONGOING
CARE
DETERMINA-
TION.—Notwithstanding clause (i), in the 
case of a review described in such clause 
that involves a termination or reduction of 
care, the notice of the determination shall 
be completed not later than 24 hours after 
the time the request for external review is 
received by the qualified external review 
entity and before the end of the approved 
period of care. 
(B) RETROSPECTIVE
DETERMINATION.—
The independent medical review panel shall 
complete a review in the case of a retrospective 
determination on an appeal of a denial of a 
claim for benefits that is referred to the review 
panel under subsection (c)(3) in no case later 
than 30 days after the date of receipt of infor-
mation under subsection (c)(2) and in no case 
later than 60 days after the date the request 
for external review is received by the qualified 
external review entity. 
(2) NOTIFICATION
OF
DETERMINATION.—The 
external review entity shall ensure that the plan or 
issuer, the participant, beneficiary, or enrollee (or 
authorized representative) and the treating health 
care professional (if any) receives a copy of the writ-
ten determination of the independent medical review 
panel prepared under subsection (d)(3)(F). Nothing 
in this paragraph shall be construed as preventing 
an entity or review panel from providing an initial 
oral notice of the review panel’s determination. 
(3) FORM
OF
NOTICES.—Determinations and 
notices under this subsection shall be written in a 
manner calculated to be understood by a participant. 
(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 review panel under this section shall be 
binding upon the plan or issuer involved.
(B) 
COMPLIANCE
WITH
DETERMINA-
TION.—If the determination of an independent 
medical review panel is to reverse the denial, 
the plan or issuer, upon the receipt of such de-
termination, shall authorize coverage to comply 
with the medical reviewer’s determination in ac-
cordance with the timeframe established by the 
medical review panel. 
(2) FAILURE TO COMPLY.—
(A) IN GENERAL.—If a plan or issuer fails 
to comply with the timeframe established under 
paragraph (1)(B) with respect to a participant, 
beneficiary, or enrollee, where such failure to 
comply is caused by the plan or issuer, the par-
ticipant, beneficiary, or enrollee may obtain the 
items or services involved (in a manner con-
sistent with the determination of the inde-
pendent external review panel) from any pro-
vider regardless of whether such provider is a 
participating provider under the plan or cov-
erage. 
(B) REIMBURSEMENT.—
(i) IN
GENERAL.—Where a partici-
pant, beneficiary, or enrollee obtains items 
or services in accordance with subpara-
graph (A), the plan or issuer involved shall 
provide for reimbursement of the costs of 
such items or services. Such reimburse-
ment shall be made to the treating health 
care professional or to the participant, ben-
eficiary, or enrollee (in the case of a partic-
ipant, beneficiary, or enrollee who pays for 
the costs of such items or services). 
(ii) AMOUNT.—The plan or issuer 
shall fully reimburse a professional, partici-
pant, beneficiary, or enrollee under clause 
(i) for the total costs of the items or serv-
ices provided (regardless of any plan limi-
tations that may apply to the coverage of 
such items or services) so long as the items 
or services were provided in a manner con-
sistent with the determination of the inde-
pendent medical review panel. 
(C) FAILURE
TO
REIMBURSE.—Where a 
plan or issuer fails to provide reimbursement to 
a professional, participant, beneficiary, or en-
rollee in accordance with this paragraph, the 
professional, participant, beneficiary, or enrollee 
may commence a civil action (or utilize other 
remedies available under law) to recover only
the amount of any such reimbursement that is 
owed by the plan or issuer and any necessary 
legal costs or expenses (including attorney’s 
fees) incurred in recovering such reimburse-
ment.
(D) AVAILABLE REMEDIES.—The remedies 
provided under this paragraph are in addition 
to any other available remedies. 
(3) PENALTIES
AGAINST
AUTHORIZED
OFFI-
CIALS FOR REFUSING TO AUTHORIZE THE DETER-
MINATION OF AN EXTERNAL REVIEW ENTITY.—
(A) MONETARY PENALTIES.—
(i) IN
GENERAL.—In any case in 
which the determination of an external re-
view entity is not followed by a group 
health plan, or by a health insurance issuer 
offering health insurance coverage, any
person who, acting in the capacity of au-
thorizing the benefit, causes such refusal 
may, in the discretion of a court of com-
petent jurisdiction, be liable to an ag-
grieved participant, beneficiary, or enrollee 
for a civil penalty in an amount of up to 
$1,000 a day from the date on which the 
determination was transmitted to the plan