I 
108TH CONGRESS 
2D SESSION 
H. R. 4628
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 
JUNE 21, 2004
Mr. DINGELL (for himself, Mr. ANDREWS, Mr. BERRY, Mr. STENHOLM, Mr. 
GEORGE MILLER of California, Mr. WAXMAN, Mr. STARK, Mr. RANGEL, 
Mr. BROWN of Ohio, Ms. PELOSI, Mr. HOYER, Mr. MENENDEZ, Mr. 
FROST, Mr. SANDLIN, Mr. EDWARDS, Mr. DAVIS of Florida, Mr. MEE-
HAN, Mr. LAMPSON, Mr. HOLDEN, Mr. GREEN of Texas, Mr. BELL, Mr. 
MOORE, Mr. TURNER of Texas, Mr. PALLONE, Mrs. CAPPS, Mr. MEEKS 
of New York, Ms. SCHAKOWSKY, Mrs. MALONEY, Ms. DELAURO, Ms. 
WATERS, Mr. LARSON of Connecticut, Mr. JACKSON of Illinois, Mr. KEN-
NEDY of Rhode Island, Ms. SLAUGHTER, Mr. SERRANO, Mr. LIPINSKI, 
Mr. ETHERIDGE, Mr. BOSWELL, Mr. STRICKLAND, Mr. HOLT, Ms. KAP-
TUR, Mr. ACKERMAN, Mr. HINCHEY, Mr. MCNULTY, Mr. GORDON, Ms. 
DEGETTE, Ms. KILPATRICK, Mr. SPRATT, Mr. SKELTON, Mr. CONYERS, 
Mr. DOYLE, Mr. OBERSTAR, Mr. STUPAK, Mr. SHERMAN, Mrs. MCCAR-
THY of New York, Ms. LINDA T. SA´NCHEZ of California, and Mrs. 
TAUSCHER) 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 
‘‘Patients’ Bill of Rights Act of 2004’’. 
(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. Availability of civil remedies. 
Sec. 403. Cooperation between Federal and State authorities. 
TITLE V—AMENDMENTS TO THE INTERNAL REVENUE CODE OF 
1986
Subtitle A—Application of patient protection provisions 
Sec. 501. Application to group health plans under the Internal Revenue Code 
of 1986. 
Sec. 502. Conforming enforcement for women’s health and cancer rights. 
Subtitle B—Health care coverage access tax incentives 
Sec. 511. Credit for health insurance expenses of small businesses. 
Sec. 512. Certain grants by private foundations to qualified health benefit pur-
chasing coalitions. 
Sec. 513. State grant program for market innovation. 
Sec. 514. Grant program to facilitate health benefits information for small em-
ployers. 
Sec. 515. State grant program for market innovation. 
TITLE VI—EFFECTIVE DATES; COORDINATION IN 
IMPLEMENTATION 
Sec. 601. Effective dates.
Sec. 602. Coordination in implementation. 
Sec. 603. Severability. 
TITLE VII—MISCELLANEOUS PROVISIONS 
Sec. 701. No impact on Social Security Trust Fund.
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-
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 ac-
cess 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 received, 
or, in a case described in subparagraph (B) or 
(C) of paragraph (3), by such earlier time as 
may be necessary to comply with the applicable 
timeline under such subparagraph. 
(B) LIMITED
EFFECT
OF
FAILURE
ON 
PLAN
OR
ISSUER’S
OBLIGATIONS.—Failure of 
the participant, beneficiary, or enrollee to 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 reviewer (or reviewers) including at least one 
practicing 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 or modify the 
denial which is the subject of the re-
view. 
(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 reviewer, the entity shall 
provide notice to the plan or issuer, the 
participant, beneficiary, or enrollee (or au-
thorized representative) filing the request, 
and the treating health care professional 
(if any) that the denial is not subject to 
independent medical review. Such notice—
(I) shall be written (and, in 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 reviewer, shall make a de-
termination within the overall timeline that 
is applicable to the case under review as 
described in subsection (e), except that if 
the entity determines that a referral to an 
independent medical reviewer is not re-
quired, 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 reviewer under this section shall make a 
new independent determination with respect to 
whether or not the denial of a claim for a ben-
efit that is the subject of the review should be 
upheld, reversed, or modified. 
(B) STANDARD
FOR
DETERMINATION.—
The independent medical reviewer’s determina-
tion relating to the medical necessity and ap-
propriateness, or the experimental or investiga-
tional nature, or the evaluation of the medical 
facts, of the item, service, or condition involved 
shall be based on the medical condition of the 
participant, beneficiary, or enrollee (including 
the medical records of the participant, bene-
ficiary, or enrollee) and valid, relevant scientific 
evidence and clinical evidence, including peer-re-
viewed medical literature or findings and in-
cluding expert opinion. 
(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 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 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 
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 reviewer or 
submitted by the plan, issuer, participant, 
beneficiary, or enrollee (or an authorized 
representative), or treating health care 
professional. 
(iv) The plan or coverage document. 
(E) INDEPENDENT
DETERMINATION.—In 
making determinations under this section, a
qualified external review entity and an inde-
pendent medical reviewer 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 REVIEWER.—An independent medical 
reviewer shall, in accordance with the deadlines 
described in subsection (e), prepare a written 
determination to uphold, reverse, or modify the 
denial under review. Such written determination 
shall include—
(i) the determination of the reviewer;
(ii) the specific reasons of the re-
viewer 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 or modify the denial under review, 
a timeframe within which the plan or 
issuer must comply with such determina-
tion. 
(G) NONBINDING NATURE OF ADDITIONAL 
RECOMMENDATIONS.—In addition to the deter-
mination under subparagraph (F), 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 affect (or be treated as part of) the deter-
mination 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 reviewer (or reviewers) shall make 
a determination on a denial of a claim for 
benefits that is referred to the reviewer 
under subsection (c)(3) in accordance with 
the medical exigencies of the case and as 
soon as possible, but in no case later than 
14 days after the date of receipt of infor-
mation under subsection (c)(2) if the re-
view involves a prior authorization of items 
or services and in no case later than 21 
days after the date the request for external 
review is received. 
(ii) EXPEDITED
DETERMINATION.—
Notwithstanding clause (i) and subject to 
clause (iii), the independent medical re-
viewer (or reviewers) shall make an expe-
dited determination on a denial of a claim 
for benefits described in clause (i), when a 
request for such an expedited determina-
tion is made by a participant, beneficiary, 
or enrollee (or authorized representative) 
at any time during the process for making 
a determination, and a health care profes-
sional certifies, with the request, that a de-
rospective determination on an appeal of a de-
nial of a claim for benefits that is referred to 
the reviewer under subsection (c)(3) in no case 
later than 30 days after the date of receipt of 
information under subsection (c)(2) and in no 
case later than 60 days after the date the re-
quest 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 re-
viewer prepared under subsection (d)(3)(F). Nothing 
in this paragraph shall be construed as preventing 
an entity or reviewer from providing an initial oral 
notice of the reviewer’s determination. 
(3) FORM
OF
NOTICES.—Determinations and 
notices under this subsection shall be written in a 
manner calculated to be understood by 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 reviewer under this section shall be binding 
upon the plan or issuer involved. 
(B) 
COMPLIANCE
WITH
DETERMINA-
TION.—If the determination of an independent 
medical reviewer is to reverse or modify the de-
nial, the plan or issuer, upon the receipt of such 
determination, shall authorize coverage to com-
ply with the medical reviewer’s determination in 
accordance with the timeframe established by 
the medical reviewer. 
(2) FAILURE TO COMPLY.—
(A) IN GENERAL.—If a plan or issuer fails 
to comply with the timeframe established under 
paragraph (1)(B) with respect to a participant, 
beneficiary, or enrollee, where such failure to 
comply is caused by the plan or issuer, the 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 reviewer) from any provider 
regardless of whether such provider is a partici-
pating provider under the plan or coverage. 
(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 reviewer. 
(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 
or issuer by the external review entity until 
the date the refusal to provide the benefit 
is corrected. 
(ii) ADDITIONAL PENALTY FOR FAIL-
ING TO FOLLOW TIMELINE.—In any case 
in which treatment was not commenced by 
the plan in accordance with the determina-
tion of an independent external reviewer, 
the Secretary shall assess a civil penalty of 
$10,000 against the plan and the plan 
shall pay such penalty to the participant, 
beneficiary, or enrollee involved. 
(B) CEASE
AND
DESIST
ORDER
AND 
ORDER OF ATTORNEY’S FEES.—In any action 
described in subparagraph (A) brought by a 
participant, beneficiary, or enrollee with respect 
to a group health plan, or a health insurance 
issuer offering health insurance coverage, in 
which a plaintiff alleges that a person referred 
to in such subparagraph has taken an action re-
sulting in a refusal of a benefit determined by 
an external appeal entity to be covered, or has
failed to take an action for which such person 
is responsible under the terms and conditions of 
the plan or coverage and which is necessary 
under the plan or coverage for authorizing a 
benefit, the court shall cause to be served on 
the defendant an order requiring the defend-
ant—
(i) to cease and desist from the al-
leged action or failure to act; and 
(ii) to pay to the plaintiff a reasonable 
attorney’s fee and other reasonable costs 
relating to the prosecution of the action on 
the charges on which the plaintiff prevails. 
(C) ADDITIONAL CIVIL PENALTIES.—
(i) IN GENERAL.—In addition to any 
penalty imposed under subparagraph (A) 
or (B), the appropriate Secretary may as-
sess a civil penalty against a person acting 
in the capacity of authorizing a benefit de-
termined by an external review entity for 
one or more group health plans, or health 
insurance issuers offering health insurance 
coverage, for—
(I) any pattern or practice of re-
peated refusal to authorize a benefit
determined by an external appeal enti-
ty to be covered; or 
(II) any pattern or practice of re-
peated violations of the requirements 
of this section with respect to such 
plan or coverage. 
(ii) 
STANDARD
OF
PROOF
AND 
AMOUNT OF PENALTY.—Such penalty shall 
be payable only upon proof by clear and 
convincing evidence of such pattern or 
practice and shall be in an amount not to 
exceed the lesser of—
(I) 25 percent of the aggregate 
value of benefits shown by the appro-
priate Secretary to have not been pro-
vided, or unlawfully delayed, in viola-
tion of this section under such pattern 
or practice; or 
(II) $500,000. 
(D) REMOVAL AND DISQUALIFICATION.—
Any person acting in the capacity of author-
izing benefits who has engaged in any such pat-
tern or practice described in subparagraph 
(C)(i) with respect to a plan or coverage, upon 
the petition of the appropriate Secretary, may
be removed by the court from such position, 
and from any other involvement, with respect to 
such a plan or coverage, and may be precluded 
from returning to any such position or involve-
ment for a period determined by the court. 
(4) PROTECTION OF LEGAL RIGHTS.—Nothing 
in this subsection or subtitle shall be construed as 
altering or eliminating any cause of action or legal 
rights or remedies of participants, beneficiaries, en-
rollees, and others under State or Federal law (in-
cluding sections 502 and 503 of the Employee Re-
tirement Income Security Act of 1974), including 
the right to file judicial actions to enforce rights. 
(g) QUALIFICATIONS
OF INDEPENDENT MEDICAL 
REVIEWERS.—
(1) IN GENERAL.—In referring a denial to 1 or 
more individuals to conduct independent medical 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 
(allopathic or osteopathic) or health care profes-
sional who—
(A) is appropriately credentialed or li-
censed in 1 or more States to deliver health 
care services; and 
(B) typically treats the condition, makes 
the diagnosis, or provides the type of treatment 
under review. 
(3) INDEPENDENCE.—
(A) IN
GENERAL.—Subject to 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 subpara-
graph (A) shall be construed to—
(i) prohibit an individual, solely on the 
basis of affiliation with the plan or issuer, 
from serving as an independent medical re-
viewer if—
(I) a non-affiliated individual is 
not reasonably available; 
(II) the affiliated individual is 
not involved in the provision of items 
or services in the case under review; 
(III) the fact of such an affili-
ation is disclosed to the plan or issuer 
and the participant, beneficiary, or 
enrollee (or authorized representative) 
and neither party objects; and 
(IV) the affiliated individual is 
not an employee of the plan or issuer 
and does not provide services exclu-
sively or primarily to or on behalf of 
the plan or issuer; 
(ii) prohibit an individual who has 
staff privileges at the institution where the 
treatment involved takes place from serv-
ing as an independent medical reviewer
merely on the basis of such affiliation if 
the affiliation is disclosed to the plan or 
issuer and the participant, beneficiary, or 
enrollee (or authorized representative), and 
neither party objects; or 
(iii) prohibit receipt of compensation 
by an independent medical reviewer from 
an entity if the compensation is provided 
consistent with paragraph (6). 
(4) PRACTICING HEALTH CARE PROFESSIONAL 
IN SAME FIELD.—
(A) IN
GENERAL.—In a case involving 
treatment, or the provision of items or serv-
ices—
(i) by a physician, a reviewer shall be 
a practicing physician (allopathic or osteo-
pathic) of the same or similar specialty, as 
a physician who, acting within the appro-
priate scope of practice within the State in 
which the service is provided or rendered, 
typically treats the condition, makes the 
diagnosis, or provides the type of treat-
ment under review; or 
(ii) by a non-physician health care 
professional, a reviewer (or reviewers) shall
include at least one practicing non-physi-
cian health care professional of the same 
or similar specialty as the non-physician 
health care professional who, acting within 
the appropriate scope of practice within 
the State in which the service is provided 
or rendered, typically treats the condition, 
makes the diagnosis, or provides the type 
of treatment under review. 
(B) PRACTICING DEFINED.—For purposes 
of this paragraph, the term ‘‘practicing’’ means, 
with respect to an individual who is a physician 
or other health care professional that the indi-
vidual provides health care services to individual 
patients on average at least 2 days per week. 
(5) PEDIATRIC EXPERTISE.—In the case of an 
external review relating to a child, a reviewer shall 
have expertise under paragraph (2) in pediatrics. 
(6) LIMITATIONS
ON
REVIEWER
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, beneficiary, or en-
rollee, 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, beneficiary, or en-
rollee (or authorized representative). 
(C) The health care professional that pro-
vides the items or services involved in the de-
nial. 
(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 appropriate Secretary shall im-
plement procedures—
(i) to assure that the selection process 
among qualified external review entities 
will not create any incentives for external 
review entities to make a decision in a bi-
ased manner; and 
(ii) for auditing a sample of decisions 
by such entities to assure that no such de-
cisions are made in a biased manner. 
No such selection process under the procedures 
implemented by the appropriate Secretary may 
give either the patient or the plan or issuer any 
ability to determine or influence the selection of 
a qualified external review entity to review the 
case of any participant, beneficiary, or enrollee. 
(B) STATE AUTHORITY WITH RESPECT TO 
QUALIFIED EXTERNAL REVIEW ENTITIES FOR 
HEALTH INSURANCE ISSUERS.—With respect to 
health insurance issuers offering health insur-
ance coverage in a State, the State may provide 
for external review activities to be conducted by
a qualified external appeal entity that is des-
ignated by the State or that is selected by the 
State in a manner determined by the State to 
assure an unbiased determination. 
(2) CONTRACT WITH QUALIFIED EXTERNAL 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 external review entities (as defined in para-
graph (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 
appropriate Secretary shall establish to assure 
there is no real or apparent conflict of interest 
in the conduct of external review activities; and 
(B) provide that the costs of the external 
review process shall be borne by the plan or 
issuer. 
Subparagraph (B) shall not be construed as apply-
ing to the imposition of a filing fee under subsection 
(b)(2)(A)(iv) or costs incurred by the participant, 
beneficiary, or enrollee (or authorized representative)
or treating health care professional (if any) in sup-
port of the review, including the provision of addi-
tional 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 fol-
lowing requirements: 
(i) The entity has (directly or through 
contracts or other arrangements) sufficient 
medical, legal, and other expertise and suf-
ficient staffing to carry out duties of a 
qualified external review entity under this 
section on a timely basis, including making 
determinations under subsection (b)(2)(A) 
and providing for independent medical 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 appropriate Secretary 
provides by regulation. 
(B) INDEPENDENCE REQUIREMENTS.—
(i) IN
GENERAL.—Subject to clause 
(ii), an entity meets the independence re-
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 
qualified external review entity of com-
pensation from a plan or issuer for the 
conduct of external review activities under 
this section if the compensation is provided 
consistent with clause (iii). 
(iii) LIMITATIONS
ON
ENTITY
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 
(II) not be contingent on any 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 appropriate 
Secretary; or 
(II) by a qualified private stand-
ard-setting organization that is ap-
proved by the appropriate Secretary 
under clause (iii). 
In taking action under subclause (I), the 
appropriate Secretary shall give deference 
to entities that are under contract with the 
Federal Government or with an applicable 
State authority to perform functions of the 
type performed by qualified external review 
entities. 
(ii) PROCESS.—The appropriate Sec-
retary shall not recognize or approve a 
process under clause (i)(I) unless the proc-
ess 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, in-
cluding meeting applicable deadlines; 
(II) will meet (and has met, in 
the case of recertification) appropriate 
indicators of fiscal integrity; 
(III) will maintain (and has 
maintained, in the case of recertifi-
cation) 
appropriate 
confidentiality 
with respect to individually identifi-
able health information obtained in 
the course of conducting external re-
view activities; and 
(IV) in the case of 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 
appropriate Secretary may approve a quali-
fied private standard-setting organization 
if such Secretary finds that the organiza-
tion only certifies (or recertifies) external 
review entities that meet at least the 
standards required for the certification (or
recertification) of external review entities 
under clause (ii). 
(iv) CONSIDERATIONS IN RECERTIFI-
CATIONS.—In conducting recertifications of 
a qualified external review entity under 
this paragraph, the appropriate Secretary 
or organization conducting the recertifi-
cation shall review compliance of the entity 
with the requirements for conducting ex-
ternal review activities under this section, 
including the following: 
(I) 
Provision 
of 
information 
under subparagraph (D). 
(II) 
Adherence 
to 
applicable 
deadlines (both by the entity and by 
independent medical reviewers it re-
fers cases to). 
(III) Compliance with limitations 
on compensation (with respect to both 
the entity and independent medical re-
viewers it refers cases to). 
(IV) Compliance with applicable 
independence requirements. 
(V) Compliance with the require-
ment of subsection (d)(1) that only
medically reviewable decisions shall be 
the subject of independent medical re-
view and with the requirement of sub-
section (d)(3) that independent med-
ical reviewers may not require cov-
erage for specifically excluded bene-
fits. 
(v) PERIOD OF CERTIFICATION OR RE-
CERTIFICATION.—A certification or recer-
tification provided under this paragraph 
shall extend for a period not to exceed 2 
years. 
(vi) REVOCATION.—A certification or 
recertification under this paragraph may 
be revoked by the appropriate Secretary or 
by the organization providing such certifi-
cation upon a showing of cause. The Sec-
retary, or organization, shall revoke a cer-
tification or deny a recertification with re-
spect to an entity if there is a showing that 
the entity has a pattern or practice of or-
dering coverage for benefits that are spe-
cifically excluded under the plan or cov-
erage.
(vii) PETITION FOR DENIAL OR WITH-
DRAWAL.—An individual may petition the 
Secretary, or an organization providing the 
certification involves, for a denial of recer-
tification or a withdrawal of a certification 
with respect to an entity under this sub-
paragraph if there is a pattern or practice 
of such entity failing to meet a require-
ment of this section. 
(viii) SUFFICIENT NUMBER OF ENTI-
TIES.—The appropriate Secretary shall 
certify and recertify a number of external 
review entities which is sufficient to ensure 
the timely and efficient provision of review 
services. 
(D) PROVISION OF INFORMATION.—
(i) IN GENERAL.—A qualified external 
review entity shall provide to the appro-
priate Secretary, in such manner and at 
such times as such Secretary may require, 
such information (relating to the denials 
which have been referred to the entity for 
the conduct of external review under this 
section) as such Secretary determines ap-
propriate to assure compliance with the
independence and other requirements of 
this section to monitor and assess the qual-
ity of its external review activities and lack 
of bias in making determinations. Such in-
formation shall include information de-
scribed in clause (ii) but shall not include 
individually identifiable medical informa-
tion. 
(ii) 
INFORMATION
TO
BE
IN-
CLUDED.—The information described in 
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-spe-
cific basis and on a health care spe-
cialty-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 
external review activities. 
(iii) INFORMATION TO BE PROVIDED 
TO CERTIFYING ORGANIZATION.—
(I) IN GENERAL.—In the case of 
a qualified external review entity 
which is certified (or recertified) 
under this subsection by a qualified 
private standard-setting organization, 
at the request of the organization, the 
entity shall provide the organization 
with the information provided to the 
appropriate Secretary under clause 
(i). 
(II) 
ADDITIONAL
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 
entity. 
(iv) USE OF INFORMATION.—Informa-
tion provided under this subparagraph may 
be used by the appropriate Secretary and 
qualified private standard-setting organiza-
tions to conduct oversight of qualified ex-
ternal review entities, including recertifi-
cation of such entities, 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-
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, func-
tion, 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 polit-
ical subdivision thereof) if there was no actual 
malice or gross misconduct in the performance 
of such duty, function, or activity.
(5) REPORT.—Not later than 12 months after 
the general effective date referred to in section 601, 
the General Accounting Office shall prepare and 
submit to the appropriate committees of Congress a 
report concerning—
(A) the information that is provided under 
paragraph (3)(D); 
(B) the number of denials that have been 
upheld by independent medical reviewers and 
the number of denials that have been reversed 
by such reviewers; and 
(C) the extent to which independent med-
ical reviewers are requiring coverage for bene-
fits that are specifically excluded under the plan 
or coverage. 
SEC. 105. HEALTH CARE CONSUMER ASSISTANCE FUND. 
(a) GRANTS.—
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the 
‘‘Secretary’’) shall establish a fund, to be known as 
the ‘‘Health Care Consumer Assistance Fund’’, to be 
used to award grants to eligible States to carry out 
consumer assistance activities (including programs 
established by States prior to the enactment of this
Act) designed to provide information, assistance, and 
referrals to consumers of health insurance products. 
(2) STATE ELIGIBILITY.—To be eligible to re-
ceive a grant under this subsection a State shall pre-
pare and submit to the Secretary an application at 
such time, in such manner, and containing such in-
formation as the Secretary may require, including a 
State plan that describes—
(A) the manner in which the State will en-
sure that the health care consumer assistance 
office (established under paragraph (4)) will 
educate and assist health care consumers in ac-
cessing needed care; 
(B) the manner in which the State will co-
ordinate and distinguish the services provided 
by the health care consumer assistance office 
with the services provided by Federal, State and 
local health-related ombudsman, information, 
protection and advocacy, insurance, and fraud 
and abuse programs; 
(C) the manner in which the State will 
provide information, outreach, and services to 
underserved, minority populations with limited 
English proficiency and populations residing in 
rural areas;
(D) the manner in which the State will 
oversee the health care consumer assistance of-
fice, its activities, product materials and evalu-
ate program effectiveness; 
(E) the manner in which the State will en-
sure that funds made available under this sec-
tion will be used to supplement, and not sup-
plant, any other Federal, State, or local funds 
expended to provide services for programs de-
scribed under this section and those described 
in subparagraphs (C) and (D); 
(F) the manner in which the State will en-
sure that health care consumer office personnel 
have the professional background and training 
to carry out the activities of the office; and 
(G) the manner in which the State will en-
sure that consumers have direct access to con-
sumer assistance personnel during regular busi-
ness hours. 
(3) AMOUNT OF GRANT.—
(A) IN GENERAL.—From amounts appro-
priated under subsection (b) for a fiscal year, 
the Secretary shall award a grant to a State in 
an amount that bears the same ratio to such 
amounts as the number of individuals within
the State covered under a group health plan or 
under health insurance coverage offered by a 
health insurance issuer bears to the total num-
ber of individuals so covered in all States (as 
determined by the Secretary). Any amounts 
provided to a State under this subsection that 
are not used by the State shall be remitted to 
the Secretary and reallocated in accordance 
with this subparagraph. 
(B) MINIMUM AMOUNT.—In no case shall 
the amount provided to a State under a grant 
under this subsection for a fiscal year be less 
than an amount equal to 0.5 percent of the 
amount appropriated for such fiscal year to 
carry out this section. 
(C) NON-FEDERAL
CONTRIBUTIONS.—A 
State will provide for the collection of non-Fed-
eral contributions for the operation of the office 
in an amount that is not less than 25 percent 
of the amount of Federal funds provided to the 
State under this section. 
(4) PROVISION OF FUNDS FOR ESTABLISHMENT 
OF OFFICE.—
(A) IN
GENERAL.—From amounts pro-
vided under a grant under this subsection, a
State shall, directly or through a contract with 
an independent, nonprofit entity with dem-
onstrated experience in serving the needs of 
health care consumers, provide for the estab-
lishment and operation of a State health care 
consumer assistance office. 
(B) ELIGIBILITY OF ENTITY.—To be eligi-
ble to enter into a contract under subparagraph 
(A), an entity shall demonstrate that it has the 
technical, organizational, and professional ca-
pacity to deliver the services described in sub-
section (b) to all public and private health in-
surance participants, beneficiaries, enrollees, or 
prospective enrollees. 
(C) EXISTING STATE ENTITY.—Nothing in 
this section shall prevent the funding of an ex-
isting health care consumer assistance program 
that otherwise meets the requirements of this 
section. 
(b) USE OF FUNDS.—
(1) BY STATE.—A State shall use amounts pro-
vided under a grant awarded under this section to 
carry out consumer assistance activities directly or 
by contract with an independent, non-profit organi-
zation. An eligible entity may use some reasonable
amount of such grant to ensure the adequate train-
ing of personnel carrying out such activities. To re-
ceive amounts under this subsection, an eligible enti-
ty shall provide consumer assistance services, includ-
ing—
(A) the operation of a toll-free telephone 
hotline to respond to consumer requests; 
(B) the dissemination of appropriate edu-
cational materials on available health insurance 
products and on how best to access health care 
and the rights and responsibilities of health 
care consumers; 
(C) the provision of education on effective 
methods to promptly and efficiently resolve 
questions, problems, and grievances; 
(D) the coordination of educational and 
outreach efforts with health plans, health care 
providers, payers, and governmental agencies; 
(E) referrals to appropriate private and 
public entities to resolve questions, problems 
and grievances; and 
(F) the provision of information and as-
sistance, including acting as an authorized rep-
resentative, regarding internal, external, or ad-
ministrative grievances or appeals procedures in
nonlitigative settings to appeal the denial, ter-
mination, or reduction of health care services, 
or the refusal to pay for such services, under a 
group health plan or health insurance coverage 
offered by a health insurance issuer. 
(2) CONFIDENTIALITY AND ACCESS TO INFOR-
MATION.—
(A) STATE
ENTITY.—With respect to a 
State that directly establishes a health care con-
sumer assistance office, such office shall estab-
lish and implement procedures and protocols in 
accordance with applicable Federal and State 
laws. 
(B) CONTRACT ENTITY.—With respect to a 
State that, through contract, establishes a 
health care consumer assistance office, such of-
fice shall establish and implement procedures 
and protocols, consistent with applicable Fed-
eral and State laws, to ensure the confiden-
tiality of all information shared by a partici-
pant, beneficiary, enrollee, or their personal 
representative and their health care providers, 
group health plans, or health insurance insurers 
with the office and to ensure that no such infor-
mation is used by the office, or released or dis-
closed to State agencies or outside persons or 
entities without the prior written authorization 
(in accordance with section 164.508 of title 45, 
Code of Federal Regulations) of the individual 
or personal representative. The office may, con-
sistent with applicable Federal and State con-
fidentiality laws, collect, use or disclose aggre-
gate information that is not individually identi-
fiable (as defined in section 164.501 of title 45, 
Code of Federal Regulations). The office shall 
provide a written description of the policies and 
procedures of the office with respect to the 
manner in which health information may be 
used or disclosed to carry out consumer assist-
ance activities. The office shall provide health 
care providers, group health plans, or health in-
surance issuers with a written authorization (in 
accordance with section 164.508 of title 45, 
Code of Federal Regulations) to allow the office 
to obtain medical information relevant to the 
matter before the office. 
(3) AVAILABILITY
OF
SERVICES.—The health 
care consumer assistance office of a State shall not 
discriminate in the provision of information, refer-
rals, and services regardless of the source of the in-
dividual’s health insurance coverage or prospective 
coverage, including individuals covered under a 
group health plan or health insurance coverage of-
fered by a health insurance issuer, the medicare or 
medicaid programs under title XVIII or XIX of the 
Social Security Act (42 U.S.C. 1395 and 1396 et 
seq.), or under any other Federal or State health 
care program. 
(4) DESIGNATION OF RESPONSIBILITIES.—
(A) WITHIN EXISTING STATE ENTITY.—If 
the health care consumer assistance office of a 
State is located within an existing State regu-
latory agency or office of an elected State offi-
cial, the State shall ensure that—
(i) there is a separate delineation of 
the funding, activities, and responsibilities 
of the office as compared to the other 
funding, activities, and responsibilities of 
the agency; and 
(ii) the office establishes and imple-
ments procedures and protocols to ensure 
the 
confidentiality 
of 
all 
information 
shared by a participant, beneficiary, or en-
rollee or their personal representative and 
their health care providers, group health
plans, or health insurance issuers with the 
office and to ensure that no information is 
disclosed to the State agency or office 
without the written authorization of the in-
dividual or their personal representative in 
accordance with paragraph (2). 
(B) CONTRACT ENTITY.—In the case of an 
entity that enters into a contract with a State 
under subsection (a)(3), the entity shall provide 
assurances that the entity has no conflict of in-
terest in carrying out the activities of the office 
and that the entity is independent of group 
health plans, health insurance issuers, pro-
viders, payers, and regulators of health care. 
(5) SUBCONTRACTS.—The health care con-
sumer assistance office of a State may carry out ac-
tivities and provide services through contracts en-
tered into with 1 or more nonprofit entities so long 
as the office can demonstrate that all of the require-
ments of this section are complied with by the office. 
(6) TERM.—A contract entered into under this 
subsection shall be for a term of 3 years. 
(c) REPORT.—Not later than 1 year after the Sec-
retary first awards grants under this section, and annually 
thereafter, the Secretary shall prepare and submit to the
appropriate committees of Congress a report concerning 
the activities funded under this section and the effective-
ness of such activities in resolving health care-related 
problems and grievances. 
(d) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated such sums as may be 
necessary to carry out this section. 
Subtitle B—Access to Care 
SEC. 111. CONSUMER CHOICE OPTION. 
(a) IN GENERAL.—If—
(1) a health insurance issuer providing health 
insurance coverage in connection with a group health 
plan offers to enrollees health insurance coverage 
which provides for coverage of services (including 
physician pathology services) only if such services 
are furnished through health care professionals and 
providers who are members of a network of health 
care professionals and providers who have entered 
into a contract with the issuer to provide such serv-
ices, or 
(2) a group health plan offers to participants or 
beneficiaries health benefits which provide for cov-
erage of services only if such services are furnished 
through health care professionals and providers who 
are members of a network of health care profes-
sionals and providers who have entered into a con-
tract with the plan to provide such services, 
then the issuer or plan shall also offer or arrange to be 
offered to such enrollees, participants, or beneficiaries (at 
the time of enrollment and during an annual open season 
as provided under subsection (c)) the option of health in-
surance coverage or health benefits which provide for cov-
erage of such services which are not furnished through 
health care professionals and providers who are members 
of such a network unless such enrollees, participants, or 
beneficiaries are offered such non-network coverage 
through another group health plan or through another 
health insurance issuer in the group market. 
(b) ADDITIONAL COSTS.—The amount of any addi-
tional premium charged by the health insurance issuer or 
group health plan for the additional cost of the creation 
and maintenance of the option described in subsection (a) 
and the amount of any additional cost sharing imposed 
under such option shall be borne by the enrollee, partici-
pant, or beneficiary unless it is paid by the health plan 
sponsor or group health plan through agreement with the 
health insurance issuer. 
(c) OPEN SEASON.—An enrollee, participant, or ben-
eficiary, may change to the offering provided under this 
section only during a time period determined by the health
insurance issuer or group health plan. Such time period 
shall occur at least annually. 
SEC. 112. CHOICE OF HEALTH CARE PROFESSIONAL. 
(a) PRIMARY CARE.—If a group health plan, or a 
health insurance issuer that offers health insurance cov-
erage, requires or provides for designation by a partici-
pant, beneficiary, or enrollee of a participating primary 
care provider, then the plan or issuer shall permit each 
participant, beneficiary, and enrollee to designate any par-
ticipating primary care provider who is available to accept 
such individual. 
(b) SPECIALISTS.—
(1) IN GENERAL.—Subject to paragraph (2), a 
group health plan and a health insurance issuer that 
offers health insurance coverage shall permit each 
participant, beneficiary, or enrollee to receive medi-
cally necessary and appropriate specialty care, pur-
suant to appropriate referral procedures, from any 
qualified participating health care professional who 
is available to accept such individual for such care. 
(2) LIMITATION.—Paragraph (1) shall not 
apply to specialty care if the plan or issuer clearly 
informs participants, beneficiaries, and enrollees of 
the limitations on choice of participating health care 
professionals with respect to such care.
(3) CONSTRUCTION.—Nothing in this sub-
section shall be construed as affecting the applica-
tion of section 114 (relating to access to specialty 
care). 
SEC. 113. ACCESS TO EMERGENCY CARE. 
(a) COVERAGE OF EMERGENCY SERVICES.—
(1) IN GENERAL.—If a group health plan, or 
health insurance coverage offered by a health insur-
ance issuer, provides or covers any benefits with re-
spect to services in an emergency department of a 
hospital, the plan or issuer shall cover emergency 
services (as defined in paragraph (2)(B))—
(A) without the need for any prior author-
ization determination; 
(B) whether the health care provider fur-
nishing such services is a participating provider 
with respect to such services; 
(C) in a manner so that, if such services 
are provided to a participant, beneficiary, or en-
rollee—
(i) by a nonparticipating health care 
provider with or without prior authoriza-
tion, or 
(ii) by a participating health care pro-
vider without prior authorization,
the participant, beneficiary, or enrollee is not 
liable for amounts that exceed the amounts of 
liability that would be incurred if the services 
were provided by a participating health care 
provider with prior authorization; and 
(D) without regard to any other term or 
condition of such coverage (other than exclusion 
or coordination of benefits, or an affiliation or 
waiting period, permitted under section 2701 of 
the Public Health Service Act, section 701 of 
the Employee Retirement Income Security Act 
of 1974, or section 9801 of the Internal Rev-
enue Code of 1986, and other than applicable 
cost-sharing). 
(2) DEFINITIONS.—In this section: 
(A) EMERGENCY
MEDICAL
CONDITION.—
The term ‘‘emergency medical condition’’ means 
a medical condition manifesting itself by acute 
symptoms of sufficient severity (including se-
vere pain) such that a prudent layperson, who 
possesses an average knowledge of health and 
medicine, could reasonably expect the absence 
of immediate medical attention to result in a 
condition described in clause (i), (ii), or (iii) of
section 1867(e)(1)(A) of the Social Security 
Act. 
(B) EMERGENCY
SERVICES.—The term 
‘‘emergency services’’ means, with respect to an 
emergency medical condition—
(i) a medical screening examination 
(as required under section 1867 of the So-
cial Security Act) that is within the capa-
bility of the emergency department of a 
hospital, including ancillary services rou-
tinely available to the emergency depart-
ment to evaluate such emergency medical 
condition, and 
(ii) within the capabilities of the staff 
and facilities available at the hospital, such 
further medical examination and treatment 
as are required under section 1867 of such 
Act to stabilize the patient. 
(C) STABILIZE.—The term ‘‘to stabilize’’, 
with respect to an emergency medical condition 
(as defined in subparagraph (A)), has the 
meaning given in section 1867(e)(3) of the So-
cial Security Act (42 U.S.C. 1395dd(e)(3)). 
(b) REIMBURSEMENT FOR MAINTENANCE CARE AND 
POST-STABILIZATION CARE.—A group health plan, and
health insurance coverage offered by a health insurance 
issuer, must provide reimbursement for maintenance care 
and post-stabilization care in accordance with the require-
ments of section 1852(d)(2) of the Social Security Act (42 
U.S.C. 1395w–22(d)(2)). Such reimbursement shall be 
provided in a manner consistent with subsection (a)(1)(C). 
(c) COVERAGE OF EMERGENCY AMBULANCE SERV-
ICES.—
(1) IN GENERAL.—If a group health plan, or 
health insurance coverage provided by a health in-
surance issuer, provides any benefits with respect to 
ambulance services and emergency services, the plan 
or issuer shall cover emergency ambulance services 
(as defined in paragraph (2)) furnished under the 
plan or coverage under the same terms and condi-
tions under subparagraphs (A) through (D) of sub-
section (a)(1) under which coverage is provided for 
emergency services. 
(2) EMERGENCY AMBULANCE SERVICES.—For 
purposes of this subsection, the term ‘‘emergency 
ambulance services’’ means ambulance services (as 
defined for purposes of section 1861(s)(7) of the So-
cial Security Act) furnished to transport an indi-
vidual who has an emergency medical condition (as 
defined in subsection (a)(2)(A)) to a hospital for the
receipt of emergency services (as defined in sub-
section (a)(2)(B)) in a case in which the emergency 
services are covered under the plan or coverage pur-
suant to subsection (a)(1) and a prudent layperson, 
with an average knowledge of health and medicine, 
could reasonably expect that the absence of such 
transport would result in placing the health of the 
individual in serious jeopardy, serious impairment of 
bodily function, or serious dysfunction of any bodily 
organ or part. 
SEC. 114. TIMELY ACCESS TO SPECIALISTS. 
(a) TIMELY ACCESS.—
(1) IN GENERAL.—A group health plan and a 
health insurance issuer offering health insurance 
coverage shall ensure that participants, beneficiaries, 
and enrollees receive timely access to specialists who 
are appropriate to the condition of, and accessible 
to, the participant, beneficiary, or enrollee, when 
such specialty care is a covered benefit under the 
plan or coverage. 
(2) RULE
OF
CONSTRUCTION.—Nothing in 
paragraph (1) shall be construed—
(A) to require the coverage under a group 
health plan or health insurance coverage of ben-
efits or services;
(B) to prohibit a plan or issuer from in-
cluding providers in the network only to the ex-
tent necessary to meet the needs of the plan’s 
or issuer’s participants, beneficiaries, or enroll-
ees; or 
(C) to override any State licensure or 
scope-of-practice law. 
(3) ACCESS TO CERTAIN PROVIDERS.—
(A) IN
GENERAL.—With respect to spe-
cialty care under this section, if a participating 
specialist is not available and qualified to pro-
vide such care to the participant, beneficiary, or 
enrollee, the plan or issuer shall provide for cov-
erage of such care by a nonparticipating spe-
cialist. 
(B) TREATMENT
OF
NONPARTICIPATING 
PROVIDERS.—If a participant, beneficiary, or 
enrollee receives care from a nonparticipating 
specialist pursuant to subparagraph (A), such 
specialty care shall be provided at no additional 
cost to the participant, beneficiary, or enrollee 
beyond what the participant, beneficiary, or en-
rollee would otherwise pay for such specialty 
care if provided by a participating specialist. 
(b) REFERRALS.—
(1) AUTHORIZATION.—Subject to subsection 
(a)(1), a group health plan or health insurance 
issuer may require an authorization in order to ob-
tain coverage for specialty services under this sec-
tion. Any such authorization—
(A) shall be for an appropriate duration of 
time or number of referrals, including an au-
thorization for a standing referral where appro-
priate; and 
(B) may not be refused solely because the 
authorization involves services of a nonpartici-
pating 
specialist 
(described 
in 
subsection 
(a)(3)). 
(2) REFERRALS FOR ONGOING SPECIAL CONDI-
TIONS.—
(A) IN GENERAL.—Subject to subsection 
(a)(1), a group health plan and a health insur-
ance issuer shall permit a participant, bene-
ficiary, or enrollee who has an ongoing special 
condition (as defined in subparagraph (B)) to 
receive a referral to a specialist for the treat-
ment of such condition and such specialist may 
authorize such referrals, procedures, tests, and 
other medical services with respect to such con-
dition, or coordinate the care for such condi-
tion, subject to the terms of a treatment plan 
(if any) referred to in subsection (c) with re-
spect to the condition. 
(B) ONGOING
SPECIAL
CONDITION
DE-
FINED.—In this subsection, the term ‘‘ongoing 
special condition’’ means a condition or disease 
that—
(i) is life-threatening, degenerative, 
potentially disabling, or congenital; and 
(ii) requires specialized medical care 
over a prolonged period of time. 
(c) TREATMENT PLANS.—
(1) IN
GENERAL.—A group health plan or 
health insurance issuer may require that the spe-
cialty care be provided—
(A) pursuant to a treatment plan, but only 
if the treatment plan—
(i) is developed by the specialist, in 
consultation with the case manager or pri-
mary care provider, and the participant, 
beneficiary, or enrollee, and 
(ii) is approved by the plan or issuer 
in a timely manner, if the plan or issuer 
requires such approval; and
(B) in accordance with applicable quality 
assurance and utilization review standards of 
the plan or issuer. 
(2) NOTIFICATION.—Nothing in paragraph (1) 
shall be construed as prohibiting a plan or issuer 
from requiring the specialist to provide the plan or 
issuer with regular updates on the specialty care 
provided, as well as all other reasonably necessary 
medical information. 
(d) SPECIALIST DEFINED.—For purposes of this sec-
tion, the term ‘‘specialist’’ means, with respect to the con-
dition of the participant, beneficiary, or enrollee, a health 
care professional, facility, or center that has adequate ex-
pertise through appropriate training and experience (in-
cluding, in the case of a child, appropriate pediatric exper-
tise) to provide high quality care in treating the condition. 
SEC. 115. PATIENT ACCESS TO OBSTETRICAL AND GYNECO-
LOGICAL CARE. 
(a) GENERAL RIGHTS.—
(1) DIRECT ACCESS.—A group health plan, and 
a health insurance issuer offering health insurance 
coverage, described in subsection (b) may not re-
quire authorization or referral by the plan, issuer, or 
any person (including a primary care provider de-
scribed in subsection (b)(2)) in the case of a female
participant, beneficiary, or enrollee who seeks cov-
erage for obstetrical or gynecological care provided 
by a participating health care professional who spe-
cializes in obstetrics or gynecology. 
(2) 
OBSTETRICAL
AND
GYNECOLOGICAL 
CARE.—A group health plan and a health insurance 
issuer described in subsection (b) shall treat the pro-
vision of obstetrical and gynecological care, and the 
ordering of related obstetrical and gynecological 
items and services, pursuant to the direct access de-
scribed under paragraph (1), by a participating 
health care professional who specializes in obstetrics 
or gynecology as the authorization of the primary 
care provider. 
(b) APPLICATION OF SECTION.—A group health plan, 
or health insurance issuer offering health insurance cov-
erage, described in this subsection is a group health plan 
or coverage that—
(1) 
provides 
coverage 
for 
obstetric 
or 
gynecologic care; and 
(2) requires the designation by a participant, 
beneficiary, or enrollee of a participating primary 
care provider. 
(c) CONSTRUCTION.—Nothing in subsection (a) shall 
be construed to—
(1) waive any exclusions of coverage under the 
terms and conditions of the plan or health insurance 
coverage with respect to coverage of obstetrical or 
gynecological care; or 
(2) preclude the group health plan or health in-
surance issuer involved from requiring that the ob-
stetrical or gynecological provider notify the primary 
care health care professional or the plan or issuer of 
treatment decisions. 
SEC. 116. ACCESS TO PEDIATRIC CARE. 
(a) PEDIATRIC CARE.—In the case of a person who 
has a child who is a participant, beneficiary, or enrollee 
under a group health plan, or health insurance coverage 
offered by a health insurance issuer, if the plan or issuer 
requires or provides for the designation of a participating 
primary care provider for the child, the plan or issuer shall 
permit such person to designate a physician (allopathic or 
osteopathic) who specializes in pediatrics as the child’s pri-
mary care provider if such provider participates in the net-
work of the plan or issuer. 
(b) CONSTRUCTION.—Nothing in subsection (a) shall 
be construed to waive any exclusions of coverage under 
the terms and conditions of the plan or health insurance 
coverage with respect to coverage of pediatric care.
SEC. 117. CONTINUITY OF CARE. 
(a) TERMINATION OF PROVIDER.—
(1) IN GENERAL.—If—
(A) a contract between a group health 
plan, or a health insurance issuer offering 
health insurance coverage, and a treating health 
care provider is terminated (as defined in para-
graph (e)(4)), or 
(B) benefits or coverage provided by a 
health care provider are terminated because of 
a change in the terms of provider participation 
in such plan or coverage, 
the plan or issuer shall meet the requirements of 
paragraph (3) with respect to each continuing care 
patient. 
(2) TREATMENT
OF
TERMINATION
OF
CON-
TRACT
WITH
HEALTH
INSURANCE
ISSUER.—If a 
contract for the provision of health insurance cov-
erage between a group health plan and a health in-
surance issuer is terminated and, as a result of such 
termination, coverage of services of a health care 
provider is terminated with respect to an individual, 
the provisions of paragraph (1) (and the succeeding 
provisions of this section) shall apply under the plan 
in the same manner as if there had been a contract 
between the plan and the provider that had been ter-
minated, but only with respect to benefits that are 
covered under the plan after the contract termi-
nation. 
(3) REQUIREMENTS.—The requirements of this 
paragraph are that the plan or issuer—
(A) notify the continuing care patient in-
volved, or arrange to have the patient notified 
pursuant to subsection (d)(2), on a timely basis 
of the termination described in paragraph (1) 
(or paragraph (2), if applicable) and the right 
to elect continued transitional care from the 
provider under this section; 
(B) provide the patient with an oppor-
tunity to notify the plan or issuer of the pa-
tient’s need for transitional care; and 
(C) subject to subsection (c), permit the 
patient to elect to continue to be covered with 
respect to the course of treatment by such pro-
vider with the provider’s consent during a tran-
sitional period (as provided for under subsection 
(b)). 
(4) CONTINUING CARE PATIENT.—For purposes 
of this section, the term ‘‘continuing care patient’’ 
means a participant, beneficiary, or enrollee who—
(A) is undergoing a course of treatment 
for a serious and complex condition from the 
provider at the time the plan or issuer receives 
or provides notice of provider, benefit, or cov-
erage termination described in paragraph (1) 
(or paragraph (2), if applicable); 
(B) is undergoing a course of institutional 
or inpatient care from the provider at the time 
of such notice; 
(C) is scheduled to undergo non-elective 
surgery from the provider at the time of such 
notice; 
(D) is pregnant and undergoing a course 
of treatment for the pregnancy from the pro-
vider at the time of such notice; or 
(E) is or was determined to be terminally 
ill (as determined under section 1861(dd)(3)(A) 
of the Social Security Act) at the time of such 
notice, but only with respect to a provider that 
was treating the terminal illness before the date 
of such notice. 
(b) TRANSITIONAL PERIODS.—
(1) SERIOUS AND COMPLEX CONDITIONS.—The 
transitional period under this subsection with re-
spect to a continuing care patient described in sub-
section (a)(4)(A) shall extend for up to 90 days (as 
determined by the treating health care professional) 
from the date of the notice described in subsection 
(a)(3)(A). 
(2) INSTITUTIONAL OR INPATIENT CARE.—The 
transitional period under this subsection for a con-
tinuing 
care 
patient 
described 
in 
subsection 
(a)(4)(B) shall extend until the earlier of—
(A) the expiration of the 90-day period be-
ginning on the date on which the notice under 
subsection (a)(3)(A) is provided; or 
(B) the date of discharge of the patient 
from such care or the termination of the period 
of institutionalization, or, if later, the date of 
completion of reasonable follow-up care. 
(3) SCHEDULED
NON-ELECTIVE
SURGERY.—
The transitional period under this subsection for a 
continuing care patient described in subsection 
(a)(4)(C) shall extend until the completion of the 
surgery involved and post-surgical follow-up care re-
lating to the surgery and occurring within 90 days 
after the date of the surgery. 
(4) 
PREGNANCY.—The 
transitional 
period 
under this subsection for a continuing care patient 
described in subsection (a)(4)(D) shall extend
through the provision of post-partum care directly 
related to the delivery. 
(5) TERMINAL ILLNESS.—The transitional pe-
riod under this subsection for a continuing care pa-
tient described in subsection (a)(4)(E) shall extend 
for the remainder of the patient’s life for care that 
is directly related to the treatment of the terminal 
illness or its medical manifestations. 
(c) PERMISSIBLE
TERMS
AND
CONDITIONS.—A 
group health plan or health insurance issuer may condi-
tion coverage of continued treatment by a provider under 
this section upon the provider agreeing to the following 
terms and conditions: 
(1) The treating health care provider agrees to 
accept reimbursement from the plan or issuer and 
continuing care patient involved (with respect to 
cost-sharing) at the rates applicable prior to the 
start of the transitional period as payment in full 
(or, in the case described in subsection (a)(2), at the 
rates applicable under the replacement plan or cov-
erage after the date of the termination of the con-
tract with the group health plan or health insurance 
issuer) and not to impose cost-sharing with respect 
to the patient in an amount that would exceed the 
cost-sharing that could have been imposed if the
contract referred to in subsection (a)(1) had not 
been terminated. 
(2) The treating health care provider agrees to 
adhere to the quality assurance standards of the 
plan or issuer responsible for payment under para-
graph (1) and to provide to such plan or issuer nec-
essary medical information related to the care pro-
vided. 
(3) The treating health care provider agrees 
otherwise to adhere to such plan’s or issuer’s policies 
and procedures, including procedures regarding re-
ferrals and obtaining prior authorization and pro-
viding services pursuant to a treatment plan (if any) 
approved by the plan or issuer. 
(d) RULES OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed—
(1) to require the coverage of benefits which 
would not have been covered if the provider involved 
remained a participating provider; or 
(2) with respect to the termination of a con-
tract under subsection (a) to prevent a group health 
plan or health insurance issuer from requiring that 
the health care provider—
(A) notify participants, beneficiaries, or en-
rollees of their rights under this section; or
(B) provide the plan or issuer with the 
name of each participant, beneficiary, or en-
rollee who the provider believes is a continuing 
care patient. 
(e) DEFINITIONS.—In this section: 
(1) CONTRACT.—The term ‘‘contract’’ includes, 
with respect to a plan or issuer and a treating 
health care provider, a contract between such plan 
or issuer and an organized network of providers that 
includes the treating health care provider, and (in 
the case of such a contract) the contract between the 
treating health care provider and the organized net-
work. 
(2) HEALTH
CARE
PROVIDER.—The term 
‘‘health care provider’’ or ‘‘provider’’ means—
(A) any individual who is engaged in the 
delivery of health care services in a State and 
who is required by State law or regulation to be 
licensed or certified by the State to engage in 
the delivery of such services in the State; and 
(B) any entity that is engaged in the deliv-
ery of health care services in a State and that, 
if it is required by State law or regulation to be 
licensed or certified by the State to engage in
100
the delivery of such services in the State, is so 
licensed. 
(3) SERIOUS AND COMPLEX CONDITION.—The 
term ‘‘serious and complex condition’’ means, with 
respect to a participant, beneficiary, or enrollee 
under the plan or coverage—
(A) in the case of an acute illness, a condi-
tion that is serious enough to require special-
ized medical treatment to avoid the reasonable 
possibility of death or permanent harm; or 
(B) in the case of a chronic illness or con-
dition, is an ongoing special condition (as de-
fined in section 114(b)(2)(B)). 
(4) TERMINATED.—The term ‘‘terminated’’ in-
cludes, with respect to a contract, the expiration or 
nonrenewal of the contract, but does not include a 
termination of the contract for failure to meet appli-
cable quality standards or for fraud. 
SEC. 118. ACCESS TO NEEDED PRESCRIPTION DRUGS. 
(a) IN GENERAL.—To the extent that a group health 
plan, or health insurance coverage offered by a health in-
surance issuer, provides coverage for benefits with respect 
to prescription drugs, and limits such coverage to drugs 
included in a formulary, the plan or issuer shall—
101
(1) ensure the participation of physicians and 
pharmacists in developing and reviewing such for-
mulary; 
(2) provide for disclosure of the formulary to 
providers; and 
(3) in accordance with the applicable quality as-
surance and utilization review standards of the plan 
or issuer, provide for exceptions from the formulary 
limitation when a non-formulary alternative is medi-
cally necessary and appropriate and, in the case of 
such an exception, apply the same cost-sharing re-
quirements that would have applied in the case of a 
drug covered under the formulary. 
(b) COVERAGE OF APPROVED DRUGS AND MEDICAL 
DEVICES.—
(1) IN GENERAL.—A group health plan (and 
health insurance coverage offered in connection with 
such a plan) that provides any coverage of prescrip-
tion drugs or medical devices shall not deny coverage 
of such a drug or device on the basis that the use 
is investigational, if the use—
(A) in the case of a prescription drug—
(i) is included in the labeling author-
ized by the application in effect for the 
drug pursuant to subsection (b) or (j) of
102
section 505 of the Federal Food, Drug, 
and Cosmetic Act, without regard to any 
postmarketing 
requirements 
that 
may 
apply under such Act; or 
(ii) is included in the labeling author-
ized by the application in effect for the 
drug under section 351 of the Public 
Health Service Act, without regard to any 
postmarketing 
requirements 
that 
may 
apply pursuant to such section; or 
(B) in the case of a medical device, is in-
cluded in the labeling authorized by a regula-
tion under subsection (d) or (3) of section 513 
of the Federal Food, Drug, and Cosmetic Act, 
an order under subsection (f) of such section, or 
an application approved under section 515 of 
such Act, without regard to any postmarketing 
requirements that may apply under such Act. 
(2) CONSTRUCTION.—Nothing in this sub-
section shall be construed as requiring a group 
health plan (or health insurance coverage offered in 
connection with such a plan) to provide any coverage 
of prescription drugs or medical devices.
103
SEC. 119. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 
APPROVED CLINICAL TRIALS. 
(a) COVERAGE.—
(1) IN GENERAL.—If a group health plan, or 
health insurance issuer that is providing health in-
surance coverage, provides coverage to a qualified in-
dividual (as defined in subsection (b)), the plan or 
issuer—
(A) may not deny the individual participa-
tion in the clinical trial referred to in subsection 
(b)(2); 
(B) subject to subsection (c), may not deny 
(or limit or impose additional conditions on) the 
coverage of routine patient costs for items and 
services furnished in connection with participa-
tion in the trial; and 
(C) may not discriminate against the indi-
vidual on the basis of the enrollee’s participa-
tion in such trial. 
(2) EXCLUSION OF CERTAIN COSTS.—For pur-
poses of paragraph (1)(B), routine patient costs do 
not include the cost of the tests or measurements 
conducted primarily for the purpose of the clinical 
trial involved. 
(3) USE OF IN-NETWORK PROVIDERS.—If one 
or more participating providers is participating in a
104
clinical trial, nothing in paragraph (1) shall be con-
strued as preventing a plan or issuer from requiring 
that a qualified individual participate in the trial 
through such a participating provider if the provider 
will accept the individual as a participant in the 
trial. 
(b) QUALIFIED INDIVIDUAL DEFINED.—For pur-
poses of subsection (a), the term ‘‘qualified individual’’ 
means an individual who is a participant or beneficiary 
in a group health plan, or who is an enrollee under health 
insurance coverage, and who meets the following condi-
tions: 
(1)(A) The individual has a life-threatening or 
serious illness for which no standard treatment is ef-
fective. 
(B) The individual is eligible to participate in 
an approved clinical trial according to the trial pro-
tocol with respect to treatment of such illness. 
(C) The individual’s participation in the trial 
offers meaningful potential for significant clinical 
benefit for the individual. 
(2) Either—
(A) the referring physician is a partici-
pating health care professional and has con-
cluded that the individual’s participation in
105
such trial would be appropriate based upon the 
individual meeting the conditions described in 
paragraph (1); or 
(B) the participant, beneficiary, or enrollee 
provides medical and scientific information es-
tablishing that the individual’s participation in 
such trial would be appropriate based upon the 
individual meeting the conditions described in 
paragraph (1). 
(c) PAYMENT.—
(1) IN GENERAL.—Under this section a group 
health plan and a health insurance issuer shall pro-
vide for payment for routine patient costs described 
in subsection (a)(2) but is not required to pay for 
costs of items and services that are reasonably ex-
pected (as determined by the appropriate Secretary) 
to be paid for by the sponsors of an approved clin-
ical trial. 
(2) PAYMENT RATE.—In the case of covered 
items and services provided by—
(A) a participating provider, the payment 
rate shall be at the agreed upon rate; or 
(B) a nonparticipating provider, the pay-
ment rate shall be at the rate the plan or issuer
106
would normally pay for comparable services 
under subparagraph (A). 
(d) APPROVED CLINICAL TRIAL DEFINED.—
(1) IN
GENERAL.—In this section, the term 
‘‘approved clinical trial’’ means a clinical research 
study or clinical investigation—
(A) approved and funded (which may in-
clude funding through in-kind contributions) by 
one or more of the following: 
(i) the National Institutes of Health; 
(ii) a cooperative group or center of 
the National Institutes of Health, includ-
ing a qualified nongovernmental research 
entity to which the National Cancer Insti-
tute has awarded a center support grant; 
(iii) either of the following if the con-
ditions described in paragraph (2) are 
met—
(I) the Department of Veterans 
Affairs; 
(II) the Department of Defense; 
or 
(B) approved by the Food and Drug Ad-
ministration.
107
(2) CONDITIONS
FOR
DEPARTMENTS.—The 
conditions described in this paragraph, for a study 
or investigation conducted by a Department, are 
that the study or investigation has been reviewed 
and approved through a system of peer review that 
the appropriate Secretary determines—
(A) to be comparable to the system of peer 
review of studies and investigations used by the 
National Institutes of Health; and 
(B) assures unbiased review of the highest 
ethical standards by qualified individuals who 
have no interest in the outcome of the review. 
(e) CONSTRUCTION.—Nothing in this section shall be 
construed to limit a plan’s or issuer’s coverage with re-
spect to clinical trials. 
SEC. 120. REQUIRED COVERAGE FOR MINIMUM HOSPITAL 
STAY FOR MASTECTOMIES AND LYMPH NODE 
DISSECTIONS 
FOR 
THE 
TREATMENT 
OF 
BREAST CANCER AND COVERAGE FOR SEC-
ONDARY CONSULTATIONS. 
(a) INPATIENT CARE.—
(1) IN GENERAL.—A group health plan, and a 
health insurance issuer providing health insurance 
coverage, that provides medical and surgical benefits 
shall ensure that inpatient coverage with respect to
108
the treatment of breast cancer is provided for a pe-
riod of time as is determined by the attending physi-
cian, in consultation with the patient, to be medi-
cally 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 de-
termine that a shorter period of hospital stay is 
medically appropriate. 
(b) PROHIBITION ON CERTAIN MODIFICATIONS.—In 
implementing the requirements of this section, a group 
health plan, and a health insurance issuer providing health 
insurance coverage, may not modify the terms and condi-
tions of coverage based on the determination by a partici-
pant, beneficiary, or enrollee to request less than the min-
imum coverage required under subsection (a). 
(c) SECONDARY CONSULTATIONS.—
(1) IN GENERAL.—A group health plan, and a 
health insurance issuer providing health insurance 
coverage, that provides coverage with respect to 
medical and surgical services provided in relation to
109
the diagnosis and treatment of cancer shall ensure 
that full coverage is provided for secondary consulta-
tions by specialists in the appropriate medical fields 
(including pathology, radiology, and oncology) to 
confirm or refute such diagnosis. Such plan or issuer 
shall ensure that full coverage is provided for such 
secondary consultation whether such consultation is 
based on a positive or negative initial diagnosis. In 
any case in which the attending physician certifies in 
writing that services necessary for such a secondary 
consultation are not sufficiently available from spe-
cialists operating under the plan or coverage with re-
spect to whose services coverage is otherwise pro-
vided 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 addi-
tional cost to the individual beyond that which the 
individual would have paid if the specialist was par-
ticipating in the network of the plan or issuer. 
(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.
110
(d) PROHIBITION ON PENALTIES OR INCENTIVES.—
A group health plan, and a health insurance issuer pro-
viding health insurance coverage, 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, 
beneficiary, or enrollee in accordance with this sec-
tion; 
(2) provide financial or other incentives to a 
physician or specialist to induce the physician or 
specialist to keep the length of inpatient stays of pa-
tients following a mastectomy, lumpectomy, or a 
lymph node dissection for the treatment of breast 
cancer below certain limits or to limit referrals for 
secondary consultations; or 
(3) provide financial or other incentives to a 
physician or specialist to induce the physician or 
specialist to refrain from referring a participant, 
beneficiary, or enrollee for a secondary consultation 
that would otherwise be covered by the plan or cov-
erage involved under subsection (c). 
Subtitle C—Access to Information 
SEC. 121. PATIENT ACCESS TO INFORMATION. 
(a) REQUIREMENT.—
(1) DISCLOSURE.—
111
(A) IN GENERAL.—A group health plan, 
and a health insurance issuer that provides cov-
erage in connection with health insurance cov-
erage, shall provide for the disclosure to partici-
pants, beneficiaries, and enrollees—
(i) of the information described in 
subsection (b) at the time of the initial en-
rollment of the participant, beneficiary, or 
enrollee under the plan or coverage; 
(ii) of such information on an annual 
basis—
(I) in conjunction with the elec-
tion period of the plan or coverage if 
the plan or coverage has such an elec-
tion period; or 
(II) in the case of a plan or cov-
erage that does not have an election 
period, in conjunction with the begin-
ning of the plan or coverage year; and 
(iii) of information relating to any 
material reduction to the benefits or infor-
mation described in such subsection or 
subsection (c), in the form of a notice pro-
vided not later than 30 days before the 
date on which the reduction takes effect.
112
(B) PARTICIPANTS, BENEFICIARIES, AND 
ENROLLEES.—The disclosure required under 
subparagraph (A) shall be provided—
(i) jointly to each participant, bene-
ficiary, and enrollee who reside at the same 
address; or 
(ii) in the case of a beneficiary or en-
rollee who does not reside at the same ad-
dress as the participant or another en-
rollee, separately to the participant or 
other enrollees and such beneficiary or en-
rollee. 
(2) PROVISION OF INFORMATION.—Information 
shall be provided to participants, beneficiaries, and 
enrollees under this section at the last known ad-
dress maintained by the plan or issuer with respect 
to such participants, beneficiaries, or enrollees, to 
the extent that such information is provided to par-
ticipants, beneficiaries, or enrollees via the United 
States Postal Service or other private delivery serv-
ice. 
(b) REQUIRED INFORMATION.—The informational 
materials to be distributed under this section shall include 
for each option available under the group health plan or 
health insurance coverage the following:
113
(1) BENEFITS.—A description of the covered 
benefits, including—
(A) any in- and out-of-network benefits; 
(B) specific preventive services covered 
under the plan or coverage if such services are 
covered; 
(C) any specific exclusions or express limi-
tations 
of 
benefits 
described 
in 
section 
104(d)(3)(C); 
(D) any other benefit limitations, including 
any annual or lifetime benefit limits and any 
monetary limits or limits on the number of vis-
its, days, or services, and any specific coverage 
exclusions; and 
(E) any definition of medical necessity 
used in making coverage determinations by the 
plan, issuer, or claims administrator. 
(2) COST SHARING.—A description of any cost-
sharing requirements, including—
(A) any premiums, deductibles, coinsur-
ance, copayment amounts, and liability for bal-
ance billing, for which the participant, bene-
ficiary, or enrollee will be responsible under 
each option available under the plan;
114
(B) any maximum out-of-pocket expense 
for which the participant, beneficiary, or en-
rollee may be liable; 
(C) any cost-sharing requirements for out-
of-network benefits or services received from 
nonparticipating providers; and 
(D) any additional cost-sharing or charges 
for benefits and services that are furnished 
without meeting applicable plan or coverage re-
quirements, such as prior authorization or 
precertification. 
(3) DISENROLLMENT.—Information relating to 
the disenrollment of a participant, beneficiary, or en-
rollee. 
(4) SERVICE AREA.—A description of the plan 
or issuer’s service area, including the provision of 
any out-of-area coverage. 
(5) PARTICIPATING PROVIDERS.—A directory of 
participating providers (to the extent a plan or 
issuer provides coverage through a network of pro-
viders) that includes, at a minimum, the name, ad-
dress, and telephone number of each participating 
provider, and information about how to inquire 
whether a participating provider is currently accept-
ing new patients.
115
(6) CHOICE OF PRIMARY CARE PROVIDER.—A 
description of any requirements and procedures to 
be used by participants, beneficiaries, and enrollees 
in selecting, accessing, or changing their primary 
care provider, including providers both within and 
outside of the network (if the plan or issuer permits 
out-of-network services), and the right to select a pe-
diatrician as a primary care provider under section 
116 for a participant, beneficiary, or enrollee who is 
a child if such section applies. 
(7) PREAUTHORIZATION
REQUIREMENTS.—A 
description of the requirements and procedures to be 
used to obtain preauthorization for health services, 
if such preauthorization is required. 
(8) EXPERIMENTAL
AND
INVESTIGATIONAL 
TREATMENTS.—A description of the process for de-
termining whether a particular item, service, or 
treatment is considered experimental or investiga-
tional, and the circumstances under which such 
treatments are covered by the plan or issuer. 
(9) SPECIALTY CARE.—A description of the re-
quirements and procedures to be used by partici-
pants, beneficiaries, and enrollees in accessing spe-
cialty care and obtaining referrals to participating 
and nonparticipating specialists, including any limi-
116
tations on choice of health care professionals re-
ferred to in section 112(b)(2) and the right to timely 
access to specialists care under section 114 if such 
section applies. 
(10) CLINICAL TRIALS.—A description of the 
circumstances and conditions under which participa-
tion in clinical trials is covered under the terms and 
conditions of the plan or coverage, and the right to 
obtain coverage for approved clinical trials under 
section 119 if such section applies. 
(11) PRESCRIPTION DRUGS.—To the extent the 
plan or issuer provides coverage for prescription 
drugs, a statement of whether such coverage is lim-
ited to drugs included in a formulary, a description 
of any provisions and cost-sharing required for ob-
taining on- and off-formulary medications, and a de-
scription of the rights of participants, beneficiaries, 
and enrollees in obtaining access to access to pre-
scription drugs under section 118 if such section ap-
plies. 
(12) EMERGENCY
SERVICES.—A summary of 
the rules and procedures for accessing emergency 
services, including the right of a participant, bene-
ficiary, or enrollee to obtain emergency services 
under the prudent layperson standard under section
117
113, if such section applies, and any educational in-
formation that the plan or issuer may provide re-
garding the appropriate use of emergency services. 
(13) CLAIMS AND APPEALS.—A description of 
the plan or issuer’s rules and procedures pertaining 
to claims and appeals, a description of the rights 
(including deadlines for exercising rights) of partici-
pants, beneficiaries, and enrollees under subtitle A 
in obtaining covered benefits, filing a claim for bene-
fits, and appealing coverage decisions internally and 
externally (including telephone numbers and mailing 
addresses of the appropriate authority), and a de-
scription of any additional legal rights and remedies 
available under section 502 of the Employee Retire-
ment Income Security Act of 1974 and applicable 
State law. 
(14) ADVANCE DIRECTIVES AND ORGAN DONA-
TION.—A description of procedures for advance di-
rectives and organ donation decisions if the plan or 
issuer maintains such procedures. 
(15) INFORMATION ON PLANS AND ISSUERS.—
The name, mailing address, and telephone number 
or numbers of the plan administrator and the issuer 
to be used by participants, beneficiaries, and enroll-
ees seeking information about plan or coverage bene-
118
fits and services, payment of a claim, or authoriza-
tion for services and treatment. Notice of whether 
the benefits under the plan or coverage are provided 
under a contract or policy of insurance issued by an 
issuer, or whether benefits are provided directly by 
the plan sponsor who bears the insurance risk. 
(16) TRANSLATION SERVICES.—A summary de-
scription of any translation or interpretation services 
(including the availability of printed information in 
languages other than English, audio tapes, or infor-
mation in Braille) that are available for non-English 
speakers and participants, beneficiaries, and enroll-
ees with communication disabilities and a description 
of how to access these items or services. 
(17) ACCREDITATION INFORMATION.—Any in-
formation that is made public by accrediting organi-
zations in the process of accreditation if the plan or 
issuer is accredited, or any additional quality indica-
tors (such as the results of enrollee satisfaction sur-
veys) that the plan or issuer makes public or makes 
available to participants, beneficiaries, and enrollees. 
(18) NOTICE OF REQUIREMENTS.—A descrip-
tion of any rights of participants, beneficiaries, and 
enrollees that are established by the Patients’ Bill of 
Rights Act of 2004 (excluding those described in
119
paragraphs (1) through (17)) if such sections apply. 
The description required under this paragraph may 
be combined with the notices of the type described 
in sections 711(d), 713(b), or 606(a)(1) of the Em-
ployee Retirement Income Security Act of 1974 and 
with any other notice provision that the appropriate 
Secretary determines may be combined, so long as 
such combination does not result in any reduction in 
the information that would otherwise be provided to 
the recipient. 
(19) AVAILABILITY OF ADDITIONAL INFORMA-
TION.—A statement that the information described 
in subsection (c), and instructions on obtaining such 
information (including telephone numbers and, if 
available, Internet websites), shall be made available 
upon request. 
(20) DESIGNATED
DECISIONMAKERS.—A de-
scription of the participants and beneficiaries with 
respect to whom each designated decisionmaker 
under the plan has assumed liability under section 
502(o) of the Employee Retirement Income Security 
Act of 1974 and the name and address of each such 
decisionmaker. 
(c) ADDITIONAL INFORMATION.—The informational 
materials to be provided upon the request of a participant,
120
beneficiary, or enrollee shall include for each option avail-
able under a group health plan or health insurance cov-
erage the following: 
(1) STATUS OF PROVIDERS.—The State licen-
sure status of the plan or issuer’s participating 
health care professionals and participating health 
care facilities, and, if available, the education, train-
ing, specialty qualifications or certifications of such 
professionals. 
(2) COMPENSATION
METHODS.—A summary 
description by category of the applicable methods 
(such as capitation, fee-for-service, salary, bundled 
payments, per diem, or a combination thereof) used 
for compensating prospective or treating health care 
professionals (including primary care providers and 
specialists) and facilities in connection with the pro-
vision of health care under the plan or coverage. 
(3) PRESCRIPTION DRUGS.—Information about 
whether a specific prescription medication is in-
cluded in the formulary of the plan or issuer, if the 
plan or issuer uses a defined formulary. 
(4) UTILIZATION REVIEW ACTIVITIES.—A de-
scription of procedures used and requirements (in-
cluding circumstances, timeframes, and appeals 
rights) under any utilization review program under
121
sections 101 and 102, including any drug formulary 
program under section 118. 
(5) EXTERNAL
APPEALS
INFORMATION.—Ag-
gregate information on the number and outcomes of 
external medical reviews, relative to the sample size 
(such as the number of covered lives) under the plan 
or under the coverage of the issuer. 
(d) MANNER OF DISCLOSURE.—The information de-
scribed in this section shall be disclosed in an accessible 
medium and format that is calculated to be understood 
by a participant or enrollee. 
(e) RULES OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to prohibit a group health plan, 
or a health insurance issuer in connection with health in-
surance coverage, from—
(1) distributing any other additional informa-
tion determined by the plan or issuer to be impor-
tant or necessary in assisting participants, bene-
ficiaries, and enrollees in the selection of a health 
plan or health insurance coverage; and 
(2) complying with the provisions of this section 
by providing information in brochures, through the 
Internet or other electronic media, or through other 
similar means, so long as—
122
(A) the disclosure of such information in 
such form is in accordance with requirements 
as the appropriate Secretary may impose, and 
(B) in connection with any such disclosure 
of information through the Internet or other 
electronic media—
(i) the recipient has affirmatively con-
sented to the disclosure of such informa-
tion in such form, 
(ii) the recipient is capable of access-
ing the information so disclosed on the re-
cipient’s individual workstation or at the 
recipient’s home, 
(iii) the recipient retains an ongoing 
right to receive paper disclosure of such in-
formation and receives, in advance of any 
attempt at disclosure of such information 
to him or her through the Internet or 
other electronic media, notice in printed 
form of such ongoing right and of the 
proper software required to view informa-
tion so disclosed, and 
(iv) the plan administrator appro-
priately ensures that the intended recipient 
is receiving the information so disclosed
123
and provides the information in printed 
form if the information is not received. 
Subtitle D—Protecting the Doctor-
patient Relationship 
SEC. 131. PROHIBITION OF INTERFERENCE WITH CERTAIN 
MEDICAL COMMUNICATIONS. 
(a) GENERAL RULE.—The provisions of any contract 
or agreement, or the operation of any contract or agree-
ment, between a group health plan or health insurance 
issuer in relation to health insurance coverage (including 
any partnership, association, or other organization that 
enters into or administers such a contract or agreement) 
and a health care provider (or group of health care pro-
viders) shall not prohibit or otherwise restrict a health 
care professional from advising such a participant, bene-
ficiary, or enrollee who is a patient of the professional 
about the health status of the individual or medical care 
or treatment for the individual’s condition or disease, re-
gardless of whether benefits for such care or treatment 
are provided under the plan or coverage, if the professional 
is acting within the lawful scope of practice. 
(b) NULLIFICATION.—Any contract provision or 
agreement that restricts or prohibits medical communica-
tions in violation of subsection (a) shall be null and void.
124
SEC. 132. PROHIBITION OF DISCRIMINATION AGAINST PRO-
VIDERS BASED ON LICENSURE. 
(a) IN GENERAL.—A group health plan, and a health 
insurance issuer with respect to health insurance coverage, 
shall not discriminate with respect to participation or in-
demnification as to any provider who is acting within the 
scope of the provider’s license or certification under appli-
cable State law, solely on the basis of such license or cer-
tification. 
(b) CONSTRUCTION.—Subsection (a) shall not be con-
strued—
(1) as requiring the coverage under a group 
health plan or health insurance coverage of a par-
ticular benefit or service or to prohibit a plan or 
issuer from including providers only to the extent 
necessary to meet the needs of the plan’s or issuer’s 
participants, beneficiaries, or enrollees or from es-
tablishing any measure designed to maintain quality 
and control costs consistent with the responsibilities 
of the plan or issuer; 
(2) to override any State licensure or scope-of-
practice law; or 
(3) as requiring a plan or issuer that offers net-
work coverage to include for participation every will-
ing provider who meets the terms and conditions of 
the plan or issuer.
125
SEC. 133. PROHIBITION AGAINST IMPROPER INCENTIVE 
ARRANGEMENTS. 
(a) IN GENERAL.—A group health plan and a health 
insurance issuer offering health insurance coverage may 
not operate any physician incentive plan (as defined in 
subparagraph (B) of section 1852(j)(4) of the Social Secu-
rity Act) unless the requirements described in clauses (i), 
(ii)(I), and (iii) of subparagraph (A) of such section are 
met with respect to such a plan. 
(b) APPLICATION.—For purposes of carrying out 
paragraph (1), any reference in section 1852(j)(4) of the 
Social Security Act to the Secretary, a Medicare+Choice 
organization, or an individual enrolled with the organiza-
tion shall be treated as a reference to the applicable au-
thority, a group health plan or health insurance issuer, 
respectively, and a participant, beneficiary, or enrollee 
with the plan or organization, respectively. 
(c) CONSTRUCTION.—Nothing in this section shall be 
construed as prohibiting all capitation and similar ar-
rangements or all provider discount arrangements. 
SEC. 134. PAYMENT OF CLAIMS. 
A group health plan, and a health insurance issuer 
offering health insurance coverage, shall provide for 
prompt payment of claims submitted for health care serv-
ices or supplies furnished to a participant, beneficiary, or 
enrollee with respect to benefits covered by the plan or
126
issuer, in a manner that is no less protective than the pro-
visions of section 1842(c)(2) of the Social Security Act 
(42 U.S.C. 1395u(c)(2)). 
SEC. 135. PROTECTION FOR PATIENT ADVOCACY. 
(a) PROTECTION FOR USE OF UTILIZATION REVIEW 
AND GRIEVANCE PROCESS.—A group health plan, and a 
health insurance issuer with respect to the provision of 
health insurance coverage, may not retaliate against a par-
ticipant, beneficiary, enrollee, or health care provider 
based on the participant’s, beneficiary’s, enrollee’s or pro-
vider’s use of, or participation in, a utilization review proc-
ess or a grievance process of the plan or issuer (including 
an internal or external review or appeal process) under 
this title. 
(b) PROTECTION
FOR
QUALITY
ADVOCACY
BY 
HEALTH CARE PROFESSIONALS.—
(1) IN GENERAL.—A group health plan and a 
health insurance issuer may not retaliate or dis-
criminate against a protected health care profes-
sional because the professional in good faith—
(A) discloses information relating to the 
care, services, or conditions affecting one or 
more participants, beneficiaries, or enrollees of 
the plan or issuer to an appropriate public reg-
ulatory agency, an appropriate private accredi-
127
tation body, or appropriate management per-
sonnel of the plan or issuer; or 
(B) initiates, cooperates, or otherwise par-
ticipates in an investigation or proceeding by 
such an agency with respect to such care, serv-
ices, or conditions. 
If an institutional health care provider is a partici-
pating provider with such a plan or issuer or other-
wise receives payments for benefits provided by such 
a plan or issuer, the provisions of the previous sen-
tence shall apply to the provider in relation to care, 
services, or conditions affecting one or more patients 
within an institutional health care provider in the 
same manner as they apply to the plan or issuer in 
relation to care, services, or conditions provided to 
one or more participants, beneficiaries, or enrollees; 
and for purposes of applying this sentence, any ref-
erence to a plan or issuer is deemed a reference to 
the institutional health care provider. 
(2) GOOD
FAITH
ACTION.—For purposes of 
paragraph (1), a protected health care professional 
is considered to be acting in good faith with respect 
to disclosure of information or participation if, with 
respect to the information disclosed as part of the 
action—
128
(A) the disclosure is made on the basis of 
personal knowledge and is consistent with that 
degree of learning and skill ordinarily possessed 
by health care professionals with the same li-
censure or certification and the same experi-
ence; 
(B) the professional reasonably believes the 
information to be true; 
(C) the information evidences either a vio-
lation of a law, rule, or regulation, of an appli-
cable accreditation standard, or of a generally 
recognized professional or clinical standard or 
that a patient is in imminent hazard of loss of 
life or serious injury; and 
(D) subject to subparagraphs (B) and (C) 
of paragraph (3), the professional has followed 
reasonable internal procedures of the plan, 
issuer, or institutional health care provider es-
tablished for the purpose of addressing quality 
concerns before making the disclosure. 
(3) EXCEPTION AND SPECIAL RULE.—
(A) GENERAL EXCEPTION.—Paragraph (1) 
does not protect disclosures that would violate 
Federal or State law or diminish or impair the 
rights of any person to the continued protection
129
of confidentiality of communications provided 
by such law. 
(B) NOTICE OF INTERNAL PROCEDURES.—
Subparagraph (D) of paragraph (2) shall not 
apply unless the internal procedures involved 
are reasonably expected to be known to the 
health care professional involved. For purposes 
of this subparagraph, a health care professional 
is reasonably expected to know of internal pro-
cedures if those procedures have been made 
available to the professional through distribu-
tion or posting. 
(C) INTERNAL PROCEDURE EXCEPTION.—
Subparagraph (D) of paragraph (2) also shall 
not apply if—
(i) the disclosure relates to an immi-
nent hazard of loss of life or serious injury 
to a patient; 
(ii) the disclosure is made to an ap-
propriate private accreditation body pursu-
ant to disclosure procedures established by 
the body; or 
(iii) the disclosure is in response to an 
inquiry made in an investigation or pro-
ceeding of an appropriate public regulatory
130
agency and the information disclosed is 
limited to the scope of the investigation or 
proceeding. 
(4) ADDITIONAL
CONSIDERATIONS.—It shall 
not be a violation of paragraph (1) to take an ad-
verse action against a protected health care profes-
sional if the plan, issuer, or provider taking the ad-
verse action involved demonstrates that it would 
have taken the same adverse action even in the ab-
sence of the activities protected under such para-
graph. 
(5) NOTICE.—A group health plan, health in-
surance issuer, and institutional health care provider 
shall post a notice, to be provided or approved by 
the Secretary of Labor, setting forth excerpts from, 
or summaries of, the pertinent provisions of this 
subsection and information pertaining to enforce-
ment of such provisions. 
(6) CONSTRUCTIONS.—
(A) DETERMINATIONS
OF
COVERAGE.—
Nothing in this subsection shall be construed to 
prohibit a plan or issuer from making a deter-
mination not to pay for a particular medical 
treatment or service or the services of a type of 
health care professional.
131
(B) ENFORCEMENT OF PEER REVIEW PRO-
TOCOLS AND INTERNAL PROCEDURES.—Noth-
ing in this subsection shall be construed to pro-
hibit a plan, issuer, or provider from estab-
lishing and enforcing reasonable peer review or 
utilization review protocols or determining 
whether a protected health care professional has 
complied with those protocols or from estab-
lishing and enforcing internal procedures for 
the purpose of addressing quality concerns. 
(C) RELATION TO OTHER RIGHTS.—Noth-
ing in this subsection shall be construed to 
abridge rights of participants, beneficiaries, en-
rollees, and protected health care professionals 
under other applicable Federal or State laws. 
(7) PROTECTED HEALTH CARE PROFESSIONAL 
DEFINED.—For purposes of this subsection, the 
term ‘‘protected health care professional’’ means an 
individual who is a licensed or certified health care 
professional and who—
(A) with respect to a group health plan or 
health insurance issuer, is an employee of the 
plan or issuer or has a contract with the plan 
or issuer for provision of services for which ben-
efits are available under the plan or issuer; or
132
(B) with respect to an institutional health 
care provider, is an employee of the provider or 
has a contract or other arrangement with the 
provider respecting the provision of health care 
services. 
Subtitle E—Definitions 
SEC. 151. DEFINITIONS. 
(a) INCORPORATION OF GENERAL DEFINITIONS.—
Except as otherwise provided, the provisions of section 
2791 of the Public Health Service Act shall apply for pur-
poses of this title in the same manner as they apply for 
purposes of title XXVII of such Act. 
(b) SECRETARY.—Except as otherwise provided, the 
term ‘‘Secretary’’ means the Secretary of Health and 
Human Services, in consultation with the Secretary of 
Labor and the term ‘‘appropriate Secretary’’ means the 
Secretary of Health and Human Services in relation to 
carrying out this title under sections 2706 and 2751 of 
the Public Health Service Act and the Secretary of Labor 
in relation to carrying out this title under section 714 of 
the Employee Retirement Income Security Act of 1974. 
(c) ADDITIONAL DEFINITIONS.—For purposes of this 
title: 
(1) APPLICABLE AUTHORITY.—The term ‘‘ap-
plicable authority’’ means—
133
(A) in the case of a group health plan, the 
Secretary of Health and Human Services and 
the Secretary of Labor; and 
(B) in the case of a health insurance issuer 
with respect to a specific provision of this title, 
the applicable State authority (as defined in 
section 2791(d) of the Public Health Service 
Act), or the Secretary of Health and Human 
Services, if such Secretary is enforcing such 
provision 
under 
section 
2722(a)(2) 
or 
2761(a)(2) of the Public Health Service Act. 
(2) ENROLLEE.—The term ‘‘enrollee’’ means, 
with respect to health insurance coverage offered by 
a health insurance issuer, an individual enrolled with 
the issuer to receive such coverage. 
(3) GROUP HEALTH PLAN.—The term ‘‘group 
health plan’’ has the meaning given such term in 
section 733(a) of the Employee Retirement Income 
Security Act of 1974, except that such term includes 
a employee welfare benefit plan treated as a group 
health plan under section 732(d) of such Act or de-
fined as such a plan under section 607(1) of such 
Act. 
(4) HEALTH CARE PROFESSIONAL.—The term 
‘‘health care professional’’ means an individual who
134
is licensed, accredited, or certified under State law 
to provide specified health care services and who is 
operating within the scope of such licensure, accredi-
tation, or certification. 
(5) HEALTH
CARE
PROVIDER.—The term 
‘‘health care provider’’ includes a physician or other 
health care professional, as well as an institutional 
or other facility or agency that provides health care 
services and that is licensed, accredited, or certified 
to provide health care items and services under ap-
plicable State law. 
(6) NETWORK.—The term ‘‘network’’ means, 
with respect to a group health plan or health insur-
ance issuer offering health insurance coverage, the 
participating health care professionals and providers 
through whom the plan or issuer provides health 
care items and services to participants, beneficiaries, 
or enrollees. 
(7) 
NONPARTICIPATING.—The 
term 
‘‘non-
participating’’ means, with respect to a health care 
provider that provides health care items and services 
to a participant, beneficiary, or enrollee under group 
health plan or health insurance coverage, a health 
care provider that is not a participating health care 
provider with respect to such items and services.
135
(8) PARTICIPATING.—The term ‘‘participating’’ 
means, with respect to a health care provider that 
provides health care items and services to a partici-
pant, beneficiary, or enrollee under group health 
plan or health insurance coverage offered by a 
health insurance issuer, a health care provider that 
furnishes such items and services under a contract 
or other arrangement with the plan or issuer. 
(9) PRIOR AUTHORIZATION.—The term ‘‘prior 
authorization’’ means the process of obtaining prior 
approval from a health insurance issuer or group 
health plan for the provision or coverage of medical 
services. 
(10) TERMS
AND
CONDITIONS.—The term 
‘‘terms and conditions’’ includes, with respect to a 
group health plan or health insurance coverage, re-
quirements imposed under this title with respect to 
the plan or coverage. 
SEC. 152. PREEMPTION; STATE FLEXIBILITY; CONSTRUC-
TION. 
(a) CONTINUED APPLICABILITY
OF STATE LAW 
WITH RESPECT TO HEALTH INSURANCE ISSUERS.—
(1) IN GENERAL.—Subject to paragraph (2), 
this title shall not be construed to supersede any 
provision of State law which establishes, implements,
136
or continues in effect any standard or requirement 
solely relating to health insurance issuers (in connec-
tion with group health insurance coverage or other-
wise) except to the extent that such standard or re-
quirement prevents the application of a requirement 
of this title. 
(2) CONTINUED
PREEMPTION
WITH
RESPECT 
TO GROUP HEALTH PLANS.—Nothing in this title 
shall be construed to affect or modify the provisions 
of section 514 of the Employee Retirement Income 
Security Act of 1974 with respect to group health 
plans. 
(3) CONSTRUCTION.—In applying this section, 
a State law that provides for equal access to, and 
availability of, all categories of licensed health care 
providers and services shall not be treated as pre-
venting the application of any requirement of this 
title. 
(b) APPLICATION
OF SUBSTANTIALLY COMPLIANT 
STATE LAWS.—
(1) IN GENERAL.—In the case of a State law 
that imposes, with respect to health insurance cov-
erage offered by a health insurance issuer and with 
respect to a group health plan that is a non-Federal 
governmental plan, a requirement that substantially
137
complies (within the meaning of subsection (c)) with 
a patient protection requirement (as defined in para-
graph (3)) and does not prevent the application of 
other requirements under this Act (except in the 
case of other substantially compliant requirements), 
in applying the requirements of this title under sec-
tion 2707 and 2753 (as applicable) of the Public 
Health Service Act (as added by title II), subject to 
subsection (a)(2)—
(A) the State law shall not be treated as 
being superseded under subsection (a); and 
(B) the State law shall apply instead of the 
patient protection requirement otherwise appli-
cable with respect to health insurance coverage 
and non-Federal governmental plans. 
(2) LIMITATION.—In the case of a group health 
plan covered under title I of the Employee Retire-
ment Income Security Act of 1974, paragraph (1) 
shall be construed to apply only with respect to the 
health insurance coverage (if any) offered in connec-
tion with the plan. 
(3) DEFINITIONS.—In this section: 
(A) 
PATIENT
PROTECTION
REQUIRE-
MENT.—The term ‘‘patient protection require-
ment’’ means a requirement under this title,
138
and includes (as a single requirement) a group 
or related set of requirements under a section 
or similar unit under this title. 
(B) 
SUBSTANTIALLY
COMPLIANT.—The 
terms ‘‘substantially compliant’’, substantially 
complies’’, or ‘‘substantial compliance’’ with re-
spect to a State law, mean that the State law 
has the same or similar features as the patient 
protection requirements and has a similar ef-
fect. 
(c) DETERMINATIONS
OF SUBSTANTIAL COMPLI-
ANCE.—
(1) CERTIFICATION BY STATES.—A State may 
submit to the Secretary a certification that a State 
law provides for patient protections that are at least 
substantially compliant with one or more patient 
protection requirements. Such certification shall be 
accompanied by such information as may be re-
quired to permit the Secretary to make the deter-
mination described in paragraph (2)(A). 
(2) REVIEW.—
(A) IN
GENERAL.—The Secretary shall 
promptly review a certification submitted under 
paragraph (1) with respect to a State law to de-
termine if the State law substantially complies
139
with the patient protection requirement (or re-
quirements) to which the law relates. 
(B) APPROVAL DEADLINES.—
(i) INITIAL REVIEW.—Such a certifi-
cation is considered approved unless the 
Secretary notifies the State in writing, 
within 90 days after the date of receipt of 
the certification, that the certification is 
disapproved (and the reasons for dis-
approval) or that specified additional infor-
mation is needed to make the determina-
tion described in subparagraph (A). 
(ii) 
ADDITIONAL
INFORMATION.—
With respect to a State that has been noti-
fied by the Secretary under clause (i) that 
specified additional information is needed 
to make the determination described in 
subparagraph (A), the Secretary shall 
make the determination within 60 days 
after the date on which such specified ad-
ditional information is received by the Sec-
retary. 
(3) APPROVAL.—
140
(A) IN GENERAL.—The Secretary shall ap-
prove a certification under paragraph (1) un-
less—
(i) the State fails to provide sufficient 
information to enable the Secretary to 
make a determination under paragraph 
(2)(A); or 
(ii) the Secretary determines that the 
State law involved does not provide for pa-
tient protections that substantially comply 
with the patient protection requirement (or 
requirements) to which the law relates. 
(B) STATE CHALLENGE.—A State that has 
a certification disapproved by the Secretary 
under subparagraph (A) may challenge such 
disapproval in the appropriate United States 
district court. 
(C) DEFERENCE
TO
STATES.—With re-
spect to a certification submitted under para-
graph (1), the Secretary shall give deference to 
the State’s interpretation of the State law in-
volved with respect to the patient protection in-
volved. 
(D) PUBLIC
NOTIFICATION.—The Sec-
retary shall—
141
(i) provide a State with a notice of the 
determination to approve or disapprove a 
certification under this paragraph; 
(ii) promptly publish in the Federal 
Register a notice that a State has sub-
mitted a certification under paragraph (1); 
(iii) promptly publish in the Federal 
Register the notice described in clause (i) 
with respect to the State; and 
(iv) annually publish the status of all 
States with respect to certifications. 
(4) CONSTRUCTION.—Nothing in this sub-
section shall be construed as preventing the certifi-
cation (and approval of certification) of a State law 
under this subsection solely because it provides for 
greater protections for patients than those protec-
tions otherwise required to establish substantial 
compliance. 
(5) PETITIONS.—
(A) PETITION PROCESS.—Effective on the 
date on which the provisions of this Act become 
effective, as provided for in section 601, a 
group health plan, health insurance issuer, par-
ticipant, beneficiary, or enrollee may submit a 
petition to the Secretary for an advisory opinion
142
as to whether or not a standard or requirement 
under a State law applicable to the plan, issuer, 
participant, beneficiary, or enrollee that is not 
the subject of a certification under this sub-
section, is superseded under subsection (a)(1) 
because such standard or requirement prevents 
the application of a requirement of this title. 
(B) OPINION.—The Secretary shall issue 
an advisory opinion with respect to a petition 
submitted under subparagraph (A) within the 
60-day period beginning on the date on which 
such petition is submitted. 
(d) DEFINITIONS.—For purposes of this section: 
(1) STATE
LAW.—The term ‘‘State law’’ in-
cludes all laws, decisions, rules, regulations, or other 
State action having the effect of law, of any State. 
A law of the United States applicable only to the 
District of Columbia shall be treated as a State law 
rather than a law of the United States. 
(2) STATE.—The term ‘‘State’’ includes a 
State, the District of Columbia, Puerto Rico, the 
Virgin Islands, Guam, American Samoa, the North-
ern Mariana Islands, any political subdivisions of 
such, or any agency or instrumentality of such.
143
SEC. 153. EXCLUSIONS. 
(a) NO BENEFIT REQUIREMENTS.—Nothing in this 
title shall be construed to require a group health plan or 
a health insurance issuer offering health insurance cov-
erage to include specific items and services under the 
terms of such a plan or coverage, other than those pro-
vided under the terms and conditions of such plan or cov-
erage. 
(b) EXCLUSION FROM ACCESS TO CARE MANAGED 
CARE PROVISIONS FOR FEE-FOR-SERVICE COVERAGE.—
(1) IN GENERAL.—The provisions of sections 
111 through 117 shall not apply to a group health 
plan or health insurance coverage if the only cov-
erage offered under the plan or coverage is fee-for-
service coverage (as defined in paragraph (2)). 
(2) FEE-FOR-SERVICE
COVERAGE
DEFINED.—
For purposes of this subsection, the term ‘‘fee-for-
service coverage’’ means coverage under a group 
health plan or health insurance coverage that—
(A) reimburses hospitals, health profes-
sionals, and other providers on a fee-for-service 
basis without placing the provider at financial 
risk; 
(B) does not vary reimbursement for such 
a provider based on an agreement to contract
144
terms and conditions or the utilization of health 
care items or services relating to such provider; 
(C) allows access to any provider that is 
lawfully authorized to provide the covered serv-
ices and that agrees to accept the terms and 
conditions of payment established under the 
plan or by the issuer; and 
(D) for which the plan or issuer does not 
require prior authorization before providing for 
any health care services. 
SEC. 154. TREATMENT OF EXCEPTED BENEFITS. 
(a) IN GENERAL.—The requirements of this title and 
the provisions of sections 502(a)(1)(C), 502(n), and 
514(d) of the Employee Retirement Income Security Act 
of 1974 (added by section 402) shall not apply to excepted 
benefits (as defined in section 733(c) of such Act), other 
than benefits described in section 733(c)(2)(A) of such 
Act, in the same manner as the provisions of part 7 of 
subtitle B of title I of such Act do not apply to such bene-
fits under subsections (b) and (c) of section 732 of such 
Act. 
(b) COVERAGE
OF
CERTAIN
LIMITED
SCOPE 
PLANS.—Only for purposes of applying the requirements 
of this title under sections 2707 and 2753 of the Public 
Health Service Act, section 714 of the Employee Retire-
145
ment Income Security Act of 1974, and section 9813 of 
the Internal Revenue Code of 1986, the following sections 
shall be deemed not to apply: 
(1) Section 2791(c)(2)(A) of the Public Health 
Service Act. 
(2) Section 733(c)(2)(A) of the Employee Re-
tirement Income Security Act of 1974. 
(3) Section 9832(c)(2)(A) of the Internal Rev-
enue Code of 1986. 
SEC. 155. REGULATIONS. 
The Secretaries of Health and Human Services, 
Labor, and the Treasury shall issue such regulations as 
may be necessary or appropriate to carry out this title. 
Such regulations shall be issued consistent with section 
104 of Health Insurance Portability and Accountability 
Act of 1996. Such Secretaries may promulgate any in-
terim final rules as the Secretaries determine are appro-
priate to carry out this title. 
SEC. 156. INCORPORATION INTO PLAN OR COVERAGE DOC-
UMENTS. 
The requirements of this title with respect to a group 
health plan or health insurance coverage are, subject to 
section 154, deemed to be incorporated into, and made 
a part of, such plan or the policy, certificate, or contract 
providing such coverage and are enforceable under law as
146
if directly included in the documentation of such plan or 
such policy, certificate, or contract. 
SEC. 157. PRESERVATION OF PROTECTIONS. 
(a) IN GENERAL.—The rights under this Act (includ-
ing the right to maintain a civil action and any other 
rights under the amendments made by this Act) may not 
be waived, deferred, or lost pursuant to any agreement 
not authorized under this Act. 
(b) EXCEPTION.—Subsection (a) shall not apply to 
an agreement providing for arbitration or participation in 
any other nonjudicial procedure to resolve a dispute if the 
agreement—
(1) is entered into knowingly and voluntarily by 
the parties involved after the dispute has arisen; or 
(2) is pursuant to the terms of a collective bar-
gaining agreement. 
Nothing in this subsection shall be construed to permit 
the waiver of the requirements of sections 103 and 104 
(relating to internal and external review).
147
TITLE 
II—APPLICATION 
OF 
QUALITY CARE STANDARDS 
TO GROUP HEALTH PLANS 
AND 
HEALTH 
INSURANCE 
COVERAGE UNDER THE PUB-
LIC HEALTH SERVICE ACT 
SEC. 201. APPLICATION TO GROUP HEALTH PLANS AND 
GROUP HEALTH INSURANCE COVERAGE. 
(a) IN GENERAL.—Subpart 2 of part A of title 
XXVII of the Public Health Service Act is amended by 
adding at the end the following new section: 
‘‘SEC. 2707. PATIENT PROTECTION STANDARDS. 
‘‘Each group health plan shall comply with patient 
protection requirements under title I of the Patients’ Bill 
of Rights Act of 2004, and each health insurance issuer 
shall comply with patient protection requirements under 
such title with respect to group health insurance coverage 
it offers, and such requirements shall be deemed to be in-
corporated into this subsection.’’. 
(b) 
CONFORMING
AMENDMENT.—Section 
2721(b)(2)(A) of such Act (42 U.S.C. 300gg–21(b)(2)(A)) 
is amended by inserting ‘‘(other than section 2707)’’ after 
‘‘requirements of such subparts’’.
148
SEC. 202. APPLICATION TO INDIVIDUAL HEALTH INSUR-
ANCE COVERAGE. 
Part B of title XXVII of the Public Health Service 
Act is amended by inserting after section 2752 the fol-
lowing new section: 
‘‘SEC. 2753. PATIENT PROTECTION STANDARDS. 
‘‘Each health insurance issuer shall comply with pa-
tient protection requirements under title I of the Patients’ 
Bill of Rights Act of 2004 with respect to individual health 
insurance coverage it offers, and such requirements shall 
be deemed to be incorporated into this subsection.’’. 
SEC. 203. COOPERATION BETWEEN FEDERAL AND STATE 
AUTHORITIES. 
Part C of title XXVII of the Public Health Service 
Act (42 U.S.C. 300gg–91 et seq.) is amended by adding 
at the end the following: 
‘‘SEC. 2793. COOPERATION BETWEEN FEDERAL AND STATE 
AUTHORITIES. 
‘‘(a) AGREEMENT WITH STATES.—A State may 
enter into an agreement with the Secretary for the delega-
tion to the State of some or all of the Secretary’s authority 
under this title to enforce the requirements applicable 
under title I of the Patients’ Bill of Rights Act of 2004 
with respect to health insurance coverage offered by a 
health insurance issuer and with respect to a group health 
plan that is a non-Federal governmental plan.
149
‘‘(b) DELEGATIONS.—Any department, agency, or in-
strumentality of a State to which authority is delegated 
pursuant to an agreement entered into under this section 
may, if authorized under State law and to the extent con-
sistent with such agreement, exercise the powers of the 
Secretary under this title which relate to such authority.’’. 
TITLE III—APPLICATION OF PA-
TIENT PROTECTION STAND-
ARDS TO FEDERAL HEALTH 
INSURANCE PROGRAMS 
SEC. 301. APPLICATION OF PATIENT PROTECTION STAND-
ARDS TO FEDERAL HEALTH INSURANCE PRO-
GRAMS. 
(a) SENSE OF CONGRESS.—It is the sense of Con-
gress that enrollees in Federal health insurance programs 
should have the same rights and privileges as those af-
forded under title I and under the amendments made by 
title IV to participants and beneficiaries under group 
health plans. 
(b) CONFORMING FEDERAL HEALTH INSURANCE 
PROGRAMS.—It is the sense of Congress that the Presi-
dent should require, by executive order, the Federal offi-
cial with authority over each Federal health insurance pro-
gram, to the extent feasible, to take such steps as are nec-
150
essary to implement the rights and privileges described in 
subsection (a) with respect to such program. 
(c) GAO REPORT
ON
ADDITIONAL
STEPS
RE-
QUIRED.—Not later than 1 year after the date of the en-
actment of this Act, the Comptroller General of the United 
States shall submit to Congress a report on statutory 
changes that are required to implement such rights and 
privileges in a manner that is consistent with the missions 
of the Federal health insurance programs and that avoids 
unnecessary duplication or disruption of such programs. 
(d) FEDERAL HEALTH INSURANCE PROGRAM.—In 
this section, the term ‘‘Federal health insurance program’’ 
means a Federal program that provides creditable cov-
erage (as defined in section 2701(c)(1) of the Public 
Health Service Act) and includes a health program of the 
Department of Veterans Affairs.
151
TITLE IV—AMENDMENTS TO THE 
EMPLOYEE RETIREMENT IN-
COME SECURITY ACT OF 1974
SEC. 401. APPLICATION OF PATIENT PROTECTION STAND-
ARDS TO GROUP HEALTH PLANS AND GROUP 
HEALTH INSURANCE COVERAGE UNDER THE 
EMPLOYEE RETIREMENT INCOME SECURITY 
ACT OF 1974. 
Subpart B of part 7 of subtitle B of title I of the 
Employee Retirement Income Security Act of 1974 is 
amended by adding at the end the following new section: 
‘‘SEC. 714. PATIENT PROTECTION STANDARDS. 
‘‘(a) IN GENERAL.—Subject to subsection (b), a 
group health plan (and a health insurance issuer offering 
group health insurance coverage in connection with such 
a plan) shall comply with the requirements of title I of 
the Patients’ Bill of Rights Act of 2004 (as in effect as 
of the date of the enactment of such Act), and such re-
quirements shall be deemed to be incorporated into this 
subsection. 
‘‘(b) PLAN SATISFACTION OF CERTAIN REQUIRE-
MENTS.—
‘‘(1) SATISFACTION
OF
CERTAIN
REQUIRE-
MENTS
THROUGH
INSURANCE.—For purposes of 
subsection (a), insofar as a group health plan pro-
152
vides benefits in the form of health insurance cov-
erage through a health insurance issuer, the plan 
shall be treated as meeting the following require-
ments of title I of the Patients’ Bill of Rights Act 
of 2004 with respect to such benefits and not be 
considered as failing to meet such requirements be-
cause of a failure of the issuer to meet such require-
ments so long as the plan sponsor or its representa-
tives did not cause such failure by the issuer: 
‘‘(A) Section 111 (relating to consumer 
choice option). 
‘‘(B) Section 112 (relating to choice of 
health care professional). 
‘‘(C) Section 113 (relating to access to 
emergency care). 
‘‘(D) Section 114 (relating to timely access 
to specialists). 
‘‘(E) Section 115 (relating to patient ac-
cess to obstetrical and gynecological care). 
‘‘(F) Section 116 (relating to access to pe-
diatric care). 
‘‘(G) Section 117 (relating to continuity of 
care), but only insofar as a replacement issuer 
assumes the obligation for continuity of care.
153
‘‘(H) Section 118 (relating to access to 
needed prescription drugs). 
‘‘(I) Section 119 (relating to coverage for 
individuals participating in approved clinical 
trials). 
‘‘(J) Section 120 (relating to required cov-
erage 
for 
minimum 
hospital 
stay 
for 
mastectomies and lymph node dissections for 
the treatment of breast cancer and coverage for 
secondary consultations). 
‘‘(K) Section 134 (relating to payment of 
claims). 
‘‘(2) INFORMATION.—With respect to informa-
tion required to be provided or made available under 
section 121 of the Patients’ Bill of Rights Act of 
2004, in the case of a group health plan that pro-
vides benefits in the form of health insurance cov-
erage through a health insurance issuer, the Sec-
retary shall determine the circumstances under 
which the plan is not required to provide or make 
available the information (and is not liable for the 
issuer’s failure to provide or make available the in-
formation), if the issuer is obligated to provide and 
make available (or provides and makes available) 
such information.
154
‘‘(3) INTERNAL APPEALS.—With respect to the 
internal appeals process required to be established 
under section 103 of such Act, in the case of a 
group health plan that provides benefits in the form 
of health insurance coverage through a health insur-
ance issuer, the Secretary shall determine the cir-
cumstances under which the plan is not required to 
provide for such process and system (and is not lia-
ble for the issuer’s failure to provide for such proc-
ess and system), if the issuer is obligated to provide 
for (and provides for) such process and system. 
‘‘(4) EXTERNAL APPEALS.—Pursuant to rules 
of the Secretary, insofar as a group health plan en-
ters into a contract with a qualified external appeal 
entity for the conduct of external appeal activities in 
accordance with section 104 of such Act, the plan 
shall be treated as meeting the requirement of such 
section and is not liable for the entity’s failure to 
meet any requirements under such section. 
‘‘(5) APPLICATION TO PROHIBITIONS.—Pursu-
ant to rules of the Secretary, if a health insurance 
issuer offers health insurance coverage in connection 
with a group health plan and takes an action in vio-
lation of any of the following sections of the Pa-
tients’ Bill of Rights Act of 2004, the group health
155
plan shall not be liable for such violation unless the 
plan caused such violation: 
‘‘(A) Section 131 (relating to prohibition of 
interference with certain medical communica-
tions). 
‘‘(B) Section 132 (relating to prohibition 
of discrimination against providers based on li-
censure). 
‘‘(C) Section 133 (relating to prohibition 
against improper incentive arrangements). 
‘‘(D) Section 135 (relating to protection 
for patient advocacy). 
‘‘(6) CONSTRUCTION.—Nothing in this sub-
section shall be construed to affect or modify the re-
sponsibilities of the fiduciaries of a group health 
plan under part 4 of subtitle B. 
‘‘(7) TREATMENT OF SUBSTANTIALLY COMPLI-
ANT STATE LAWS.—For purposes of applying this 
subsection in connection with health insurance cov-
erage, any reference in this subsection to a require-
ment in a section or other provision in the Patients’ 
Bill of Rights Act of 2004 with respect to a health 
insurance issuer is deemed to include a reference to 
a requirement under a State law that substantially 
complies (as determined under section 152(c) of
156
such Act) with the requirement in such section or 
other provisions. 
‘‘(8) APPLICATION TO CERTAIN PROHIBITIONS 
AGAINST RETALIATION.—With respect to compliance 
with the requirements of section 135(b)(1) of the 
Patients’ Bill of Rights Act of 2004, for purposes of 
this subtitle the term ‘group health plan’ is deemed 
to include a reference to an institutional health care 
provider. 
‘‘(c) ENFORCEMENT OF CERTAIN REQUIREMENTS.—
‘‘(1) COMPLAINTS.—Any protected health care 
professional who believes that the professional has 
been retaliated or discriminated against in violation 
of section 135(b)(1) of the Patients’ Bill of Rights 
Act of 2004 may file with the Secretary a complaint 
within 180 days of the date of the alleged retaliation 
or discrimination. 
‘‘(2) INVESTIGATION.—The Secretary shall in-
vestigate such complaints and shall determine if a 
violation of such section has occurred and, if so, 
shall issue an order to ensure that the protected 
health care professional does not suffer any loss of 
position, pay, or benefits in relation to the plan, 
issuer, or provider involved, as a result of the viola-
tion found by the Secretary.
157
‘‘(d) CONFORMING REGULATIONS.—The Secretary 
shall issue regulations to coordinate the requirements on 
group health plans and health insurance issuers under this 
section with the requirements imposed under the other 
provisions of this title. In order to reduce duplication and 
clarify the rights of participants and beneficiaries with re-
spect to information that is required to be provided, such 
regulations shall coordinate the information disclosure re-
quirements under section 121 of the Patients’ Bill of 
Rights Act of 2004 with the reporting and disclosure re-
quirements imposed under part 1, so long as such coordi-
nation does not result in any reduction in the information 
that would otherwise be provided to participants and bene-
ficiaries.’’. 
(b) SATISFACTION OF ERISA CLAIMS PROCEDURE 
REQUIREMENT.—Section 503 of such Act (29 U.S.C. 
1133) is amended by inserting ‘‘(a)’’ after ‘‘Sec. 503.’’ and 
by adding at the end the following new subsection: 
‘‘(b) In the case of a group health plan (as defined 
in section 733), compliance with the requirements of sub-
title A of title I of the Patients’ Bill of Rights Act of 2004, 
and compliance with regulations promulgated by the Sec-
retary, in the case of a claims denial, shall be deemed com-
pliance with subsection (a) with respect to such claims de-
nial.’’.
158
(c) CONFORMING AMENDMENTS.—(1) Section 732(a) 
of such Act (29 U.S.C. 1185(a)) is amended by striking 
‘‘section 711’’ and inserting ‘‘sections 711 and 714’’. 
(2) The table of contents in section 1 of such Act 
is amended by inserting after the item relating to section 
713 the following new item:
‘‘714. Patient protection standards.’’.
(3) Section 502(b)(3) of such Act (29 U.S.C. 
1132(b)(3)) is amended by inserting ‘‘(other than section 
135(b))’’ after ‘‘part 7’’. 
SEC. 402. AVAILABILITY OF CIVIL REMEDIES. 
(a) AVAILABILITY OF FEDERAL CIVIL REMEDIES IN 
CASES NOT INVOLVING MEDICALLY REVIEWABLE DECI-
SIONS.—
(1) IN GENERAL.—Section 502 of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 
1132) is amended by adding at the end the following 
new subsections: 
‘‘(n) CAUSE OF ACTION RELATING TO PROVISION OF 
HEALTH BENEFITS.—
‘‘(1) IN GENERAL.—In any case in which—
‘‘(A) a person who is a fiduciary of a 
group health plan, a health insurance issuer of-
fering health insurance coverage in connection 
with the plan, or an agent of the plan, issuer, 
or plan sponsor, upon consideration of a claim
159
for benefits of a participant or beneficiary 
under section 102 of the Patients’ Bill of 
Rights Act of 2004 (relating to procedures for 
initial claims for benefits and prior authoriza-
tion determinations) or upon review of a denial 
of such a claim under section 103 of such Act 
(relating to internal appeal of a denial of a 
claim for benefits), fails to exercise ordinary 
care in making a decision—
‘‘(i) regarding whether an item or 
service is covered under the terms and con-
ditions of the plan or coverage, 
‘‘(ii) regarding whether an individual 
is a participant or beneficiary who is en-
rolled under the terms and conditions of 
the plan or coverage (including the applica-
bility of any waiting period under the plan 
or coverage), or 
‘‘(iii) as to the application of cost-
sharing requirements or the application of 
a specific exclusion or express limitation on 
the amount, duration, or scope of coverage 
of items or services under the terms and 
conditions of the plan or coverage, and
160
‘‘(B) such failure is a proximate cause of 
personal injury to, or the death of, the partici-
pant or beneficiary, 
such plan, plan sponsor, or issuer shall be liable to 
the participant or beneficiary (or the estate of such 
participant or beneficiary) for economic and non-
economic damages (but not exemplary or punitive 
damages) in connection with such personal injury or 
death. 
‘‘(2) CAUSE
OF
ACTION
MUST
NOT
INVOLVE 
MEDICALLY REVIEWABLE DECISION.—
‘‘(A) IN GENERAL.—A cause of action is 
established under paragraph (1)(A) only if the 
decision referred to in paragraph (1)(A) does 
not include a medically reviewable decision. 
‘‘(B) 
MEDICALLY
REVIEWABLE
DECI-
SION.—For purposes of this subsection, the 
term ‘medically reviewable decision’ means a de-
nial of a claim for benefits under the plan 
which is described in section 104(d)(2) of the 
Patients’ Bill of Rights Act of 2004 (relating to 
medically reviewable decisions). 
‘‘(3) LIMITATION REGARDING CERTAIN TYPES 
OF ACTIONS SAVED FROM PREEMPTION OF STATE 
LAW.—A cause of action is not established under
161
paragraph (1)(A) in connection with a failure de-
scribed in paragraph (1)(A) to the extent that a 
cause of action under State law (as defined in sec-
tion 514(c)) for such failure would not be preempted 
under section 514. 
‘‘(4) DEFINITIONS AND RELATED RULES.—For 
purposes of this subsection.—
‘‘(A) ORDINARY
CARE.—The term ‘ordi-
nary care’ means, with respect to a determina-
tion on a claim for benefits, that degree of care, 
skill, and diligence that a reasonable and pru-
dent individual would exercise in making a fair 
determination on a claim for benefits of like 
kind to the claims involved. 
‘‘(B) PERSONAL INJURY.—The term ‘per-
sonal injury’ means a physical injury and in-
cludes an injury arising out of the treatment 
(or failure to treat) a mental illness or disease. 
‘‘(C) CLAIM FOR BENEFITS; DENIAL.—The 
terms ‘claim for benefits’ and ‘denial of a claim 
for benefits’ have the meanings provided such 
terms in section 102(e) of the Patients’ Bill of 
Rights Act of 2004. 
‘‘(D) TERMS AND CONDITIONS.—The term 
‘terms and conditions’ includes, with respect to
162
a group health plan or health insurance cov-
erage, requirements imposed under title I of the 
Patients’ Bill of Rights Act of 2004. 
‘‘(E) TREATMENT
OF
EXCEPTED
BENE-
FITS.—Under section 154(a) of the Patients’ 
Bill of Rights Act of 2004, the provisions of 
this subsection and subsection (a)(1)(C) do not 
apply to certain excepted benefits. 
‘‘(5) EXCLUSION OF EMPLOYERS AND OTHER 
PLAN SPONSORS.—
‘‘(A) CAUSES
OF
ACTION
AGAINST
EM-
PLOYERS AND PLAN SPONSORS PRECLUDED.—
Subject to subparagraph (B), paragraph (1)(A) 
does not authorize a cause of action against an 
employer or other plan sponsor maintaining the 
plan (or against an employee of such an em-
ployer or sponsor acting within the scope of em-
ployment). 
‘‘(B) CERTAIN
CAUSES
OF
ACTION
PER-
MITTED.—Notwithstanding subparagraph (A), 
a cause of action may arise against an employer 
or other plan sponsor (or against an employee 
of such an employer or sponsor acting within 
the scope of employment) under paragraph 
(1)(A), to the extent there was direct participa-
163
tion by the employer or other plan sponsor (or 
employee) in the decision of the plan under sec-
tion 102 of the Patients’ Bill of Rights Act of 
2004 upon consideration of a claim for benefits 
or under section 103 of such Act upon review 
of a denial of a claim for benefits. 
‘‘(C) DIRECT PARTICIPATION.—
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (B), the term ‘direct partici-
pation’ means, in connection with a deci-
sion described in paragraph (1)(A), the ac-
tual making of such decision or the actual 
exercise of control in making such decision. 
‘‘(ii) RULES OF CONSTRUCTION.—For 
purposes of clause (i), the employer or plan 
sponsor (or employee) shall not be con-
strued to be engaged in direct participation 
because of any form of decisionmaking or 
other conduct that is merely collateral or 
precedent to the decision described in 
paragraph (1)(A) on a particular claim for 
benefits of a participant or beneficiary, in-
cluding (but not limited to)—
‘‘(I) any participation by the em-
ployer or other plan sponsor (or em-
164
ployee) in the selection of the group 
health plan or health insurance cov-
erage involved or the third party ad-
ministrator or other agent; 
‘‘(II) any engagement by the em-
ployer or other plan sponsor (or em-
ployee) in any cost-benefit analysis 
undertaken in connection with the se-
lection of, or continued maintenance 
of, the plan or coverage involved; 
‘‘(III) any participation by the 
employer or other plan sponsor (or 
employee) in the process of creating, 
continuing, modifying, or terminating 
the plan or any benefit under the 
plan, if such process was not substan-
tially focused solely on the particular 
situation of the participant or bene-
ficiary 
referred 
to 
in 
paragraph 
(1)(A); and 
‘‘(IV) any participation by the 
employer or other plan sponsor (or 
employee) in the design of any benefit 
under the plan, including the amount
165
of copayment and limits connected 
with such benefit. 
‘‘(iii) IRRELEVANCE OF CERTAIN COL-
LATERAL
EFFORTS
MADE
BY
EMPLOYER 
OR PLAN SPONSOR.—For purposes of this 
subparagraph, an employer or plan sponsor 
shall not be treated as engaged in direct 
participation in a decision with respect to 
any claim for benefits or denial thereof in 
the case of any particular participant or 
beneficiary solely by reason of—
‘‘(I) any efforts that may have 
been made by the employer or plan 
sponsor to advocate for authorization 
of coverage for that or any other par-
ticipant or beneficiary (or any group 
of participants or beneficiaries), or 
‘‘(II) any provision that may 
have been made by the employer or 
plan sponsor for benefits which are 
not covered under the terms and con-
ditions of the plan for that or any 
other participant or beneficiary (or 
any group of participants or bene-
ficiaries).
166
‘‘(D) APPLICATION TO CERTAIN PLANS.—
‘‘(i) IN
GENERAL.—Notwithstanding 
any other provision of this subsection, no 
group health plan described in clause (ii) 
(or plan sponsor of such a plan) shall be 
liable under paragraph (1) for the perform-
ance of, or the failure to perform, any non-
medically reviewable duty under the plan. 
‘‘(ii) DEFINITION.—A group health 
plan described in this clause is—
‘‘(I) a group health plan that is 
self-insured and self administered by 
an employer (including an employee of 
such an employer acting within the 
scope of employment); or 
‘‘(II) a multiemployer plan as de-
fined in section 3(37)(A) (including 
an employee of a contributing em-
ployer or of the plan, or a fiduciary of 
the plan, acting within the scope of 
employment or fiduciary responsi-
bility) that is self-insured and self-ad-
ministered. 
‘‘(6) EXCLUSION OF PHYSICIANS AND OTHER 
HEALTH CARE PROFESSIONALS.—
167
‘‘(A) IN GENERAL.—No treating physician 
or other treating health care professional of the 
participant or beneficiary, and no person acting 
under the direction of such a physician or 
health care professional, shall be liable under 
paragraph (1) for the performance of, or the 
failure to perform, any non-medically reviewable 
duty of the plan, the plan sponsor, or any 
health insurance issuer offering health insur-
ance coverage in connection with the plan. 
‘‘(B) DEFINITIONS.—For purposes of sub-
paragraph (A)—
‘‘(i) HEALTH CARE PROFESSIONAL.—
The term ‘health care professional’ means 
an individual who is licensed, accredited, or 
certified under State law to provide speci-
fied health care services and who is oper-
ating within the scope of such licensure, 
accreditation, or certification. 
‘‘(ii) NON-MEDICALLY
REVIEWABLE 
DUTY.—The term ‘non-medically review-
able duty’ means a duty the discharge of 
which does not include the making of a 
medically reviewable decision.
168
‘‘(7) EXCLUSION OF HOSPITALS.—No treating 
hospital of the participant or beneficiary shall be lia-
ble under paragraph (1) for the performance of, or 
the failure to perform, any non-medically reviewable 
duty (as defined in paragraph (6)(B)(ii)) of the 
plan, the plan sponsor, or any health insurance 
issuer offering health insurance coverage in connec-
tion with the plan. 
‘‘(8) RULE
OF
CONSTRUCTION
RELATING
TO 
EXCLUSION
FROM
LIABILITY
OF
PHYSICIANS, 
HEALTH CARE PROFESSIONALS, AND HOSPITALS.—
Nothing in paragraph (6) or (7) shall be construed 
to limit the liability (whether direct or vicarious) of 
the plan, the plan sponsor, or any health insurance 
issuer offering health insurance coverage in connec-
tion with the plan. 
‘‘(9) REQUIREMENT OF EXHAUSTION.—
‘‘(A) IN GENERAL.—A cause of action may 
not be brought under paragraph (1) in connec-
tion with any denial of a claim for benefits of 
any individual until all administrative processes 
under sections 102 and 103 of the Patients’ 
Bill of Rights Act of 2004 (if applicable) have 
been exhausted.
169
‘‘(B) EXCEPTION FOR NEEDED CARE.—A 
participant or beneficiary may seek relief exclu-
sively in Federal court under subsection 
502(a)(1)(B) prior to the exhaustion of admin-
istrative remedies under sections 102, 103, or 
104 of the Patients’ Bill of Rights Act of 2004 
(as required under subparagraph (A)) if it is 
demonstrated to the court that the exhaustion 
of such remedies would cause irreparable harm 
to the health of the participant or beneficiary. 
Notwithstanding the awarding of relief under 
subsection 502(a)(1)(B) pursuant to this sub-
paragraph, no relief shall be available as a re-
sult of, or arising under, paragraph (1)(A) or 
paragraph (10)(B), with respect to a partici-
pant or beneficiary, unless the requirements of 
subparagraph (A) are met. 
‘‘(C) RECEIPT OF BENEFITS DURING AP-
PEALS PROCESS.—Receipt by the participant or 
beneficiary of the benefits involved in the claim 
for benefits during the pendency of any admin-
istrative processes referred to in subparagraph 
(A) or of any action commenced under this sub-
section—
170
‘‘(i) shall not preclude continuation of 
all such administrative processes to their 
conclusion if so moved by any party, and 
‘‘(ii) shall not preclude any liability 
under subsection (a)(1)(C) and this sub-
section in connection with such claim. 
The court in any action commenced under this 
subsection shall take into account any receipt of 
benefits during such administrative processes or 
such action in determining the amount of the 
damages awarded. 
‘‘(D) 
ADMISSIBLE.—Any 
determination 
made by a reviewer in an administrative pro-
ceeding under section 103 of the Patients’ Bill 
of Rights Act of 2004 shall be admissible in 
any Federal court proceeding and shall be pre-
sented to the trier of fact. 
‘‘(10) STATUTORY DAMAGES.—
‘‘(A) IN
GENERAL.—The remedies set 
forth in this subsection (n) shall be the exclu-
sive remedies for causes of action brought 
under this subsection. 
‘‘(B) ASSESSMENT OF CIVIL PENALTIES.—
In addition to the remedies provided for in 
paragraph (1) (relating to the failure to provide