119
scription required under this paragraph may be com-
bined with the notices of the type described in sec-
tions 711(d), 713(b), or 606(a)(1) of the Employee 
Retirement Income Security Act of 1974 and with 
any other notice provision that the appropriate Sec-
retary 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,
beneficiary, or enrollee shall include for each option avail-
120
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 
an 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 
shall not apply to excepted benefits (as defined in section 
733(c) of such Act), other than benefits described in sec-
tion 733(c)(2)(A) of such Act, in the same manner as the 
provisions of part 7 of subtitle B of title I of such Act 
do not apply to such benefits under subsections (b) and 
(c) of section 732 of such Act. 
(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-
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:
145
(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 
if directly included in the documentation of such plan or 
such policy, certificate, or contract.
146
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 is entered into knowingly and voluntarily by the 
parties involved after the dispute has arisen or is pursuant 
to the terms of a collective bargaining 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).
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:
147
‘‘SEC. 2707. PATIENT PROTECTION STANDARDS. 
‘‘Each group health plan shall comply with patient 
protection requirements under title I of the Patient Pro-
tection Act, and each health insurance issuer shall comply 
with patient protection requirements under such title with 
respect to group health insurance coverage it offers, and 
such requirements shall be deemed to be incorporated into 
this subsection.’’. 
(b) 
CONFORMING
AMENDMENT.—Section 
2721(b)(2)(A) of such Act (42 U.S.C. 300gg–21(b)(2)(A)) 
is amended by inserting ‘‘(other than section 2707)’’ after 
‘‘requirements of such subparts’’. 
SEC. 202. APPLICATION TO INDIVIDUAL HEALTH 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 Patient 
Protection Act with respect to individual health insurance 
coverage it offers, and such requirements shall be deemed 
to be incorporated into this subsection.’’.
148
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 delegation 
to the State of some or all of the Secretary’s authority 
under this title to enforce the requirements applicable 
under title I of the Patient Protection Act 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. 
‘‘(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.’’.
149
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-
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
150
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. 
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
151
the Patient Protection Act (as in effect as of the date of 
the enactment of such Act), and such requirements shall 
be deemed to be incorporated into this subsection. 
‘‘(b) PLAN SATISFACTION OF CERTAIN REQUIRE-
MENTS.—
‘‘(1) SATISFACTION
OF
CERTAIN
REQUIRE-
MENTS
THROUGH
INSURANCE.—For purposes of 
subsection (a), insofar as a group health plan pro-
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 Patient Protection Act with 
respect to such benefits and not be considered as 
failing to meet such requirements because of a fail-
ure of the issuer to meet such requirements so long 
as the plan sponsor or its representatives did not 
cause such failure by the issuer: 
‘‘(A) Section 111 (relating to consumer 
choice option). 
‘‘(B) Section 112 (relating to choice of 
health care professional). 
‘‘(C) Section 113 (relating to access to 
emergency care). 
‘‘(D) Section 114 (relating to timely access 
to specialists).
152
‘‘(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. 
‘‘(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 Patient Protection Act, in the 
case of a group health plan that provides benefits in 
the form of health insurance coverage through a 
health insurance issuer, the Secretary shall deter-
153
mine the circumstances under which the plan is not 
required to provide or make available the informa-
tion (and is not liable for the issuer’s failure to pro-
vide or make available the information), if the issuer 
is obligated to provide and make available (or pro-
vides and makes available) such information. 
‘‘(3) INTERNAL APPEALS.—With respect to the 
internal appeals process required to be established 
under section 103 of such Act, in the case of a 
group health plan that provides benefits in the form 
of health insurance coverage through a health 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.
154
‘‘(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 Patient 
Protection Act, the group health plan shall not be 
liable for such violation unless the plan caused such 
violation: 
‘‘(A) Section 131 (relating to prohibition of 
interference with certain medical 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-
155
erage, any reference in this subsection to a require-
ment in a section or other provision in the Patient 
Protection Act with respect to a health insurance 
issuer is deemed to include a reference to a require-
ment under a State law that substantially complies 
(as determined under section 152(c) of such Act) 
with the requirement in such section or other provi-
sions. 
‘‘(8) APPLICATION TO CERTAIN PROHIBITIONS 
AGAINST RETALIATION.—With respect to compliance 
with the requirements of section 135(b)(1) of the 
Patient Protection Act, 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 Patient Protection Act 
may file with the Secretary a complaint within 180 
days of the date of the alleged retaliation or dis-
crimination. 
‘‘(2) INVESTIGATION.—The Secretary shall in-
vestigate such complaints and shall determine if a 
violation of such section has occurred and, if so,
156
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. 
‘‘(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 Patient Protection 
Act with the reporting and disclosure requirements im-
posed under part 1, so long as such coordination does not 
result in any reduction in the information that would oth-
erwise be provided to participants and beneficiaries.’’. 
(b) SATISFACTION OF ERISA CLAIMS PROCEDURE 
REQUIREMENT.—Section 503 of such Act (29 U.S.C. 
1133) is amended by inserting ‘‘(a)’’ after ‘‘SEC. 503.’’ 
and by adding at the end the following new subsection: 
‘‘(b) In the case of a group health plan (as defined 
in section 733), compliance with the requirements of sub-
title A of title I of the Patient Protection Act, and compli-
157
ance with regulations promulgated by the Secretary, in the 
case of a claims denial, shall be deemed compliance with 
subsection (a) with respect to such claims denial.’’. 
(c) CONFORMING AMENDMENTS.—(1) Section 732(a) 
of such Act (29 U.S.C. 1185(a)) is amended by striking 
‘‘section 711’’ and inserting ‘‘sections 711 and 714’’. 
(2) The table of contents in section 1 of such Act 
is amended by inserting after the item relating to section 
713 the following new item:
‘‘Sec. 714. Patient protection standards.’’.
(3) Section 502(b)(3) of such Act (29 U.S.C. 
1132(b)(3)) is amended by inserting ‘‘(other than section 
135(b))’’ after ‘‘part 7’’. 
SEC. 402. COOPERATION BETWEEN FEDERAL AND STATE 
AUTHORITIES. 
Subpart C of part 7 of subtitle B of title I of the 
Employee Retirement Income Security Act of 1974 (29 
U.S.C. 1191 et seq.) is amended by adding at the end 
the following new section: 
‘‘SEC. 735. COOPERATION BETWEEN FEDERAL AND STATE 
AUTHORITIES. 
‘‘(a) AGREEMENT WITH STATES.—A State may enter 
into an agreement with the Secretary for the delegation 
to the State of some or all of the Secretary’s authority 
under this title to enforce the requirements applicable 
under title I of the Patient Protection Act with respect
158
to health insurance coverage offered by a health insurance 
issuer. 
‘‘(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.’’. 
SEC. 403. SENSE OF THE CONGRESS CONCERNING THE IM-
PORTANCE OF CERTAIN UNPAID SERVICES. 
It is the sense of the Congress that the court should 
consider the loss of a nonwage earning spouse or parent 
as an economic loss for the purposes of this section. Fur-
thermore, the court should define the compensation for the 
loss not as minimum services, but, rather, in terms that 
fully compensate for the true and whole replacement cost 
to the family. 
TITLE V—AMENDMENTS TO THE 
INTERNAL 
REVENUE 
CODE 
OF 1986
SEC. 501. APPLICATION TO GROUP HEALTH PLANS UNDER 
THE INTERNAL REVENUE CODE OF 1986. 
Subchapter B of chapter 100 of the Internal Revenue 
Code of 1986 is amended—
159
(1) in the table of sections, by inserting after 
the item relating to section 9812 the following new 
item:
‘‘Sec. 9813. Standard relating to patients’ bill of rights.’’;
and 
(2) by inserting after section 9812 the fol-
lowing:
‘‘SEC. 9813. STANDARD RELATING TO PATIENTS’ BILL OF 
RIGHTS. 
‘‘A group health plan shall comply with the require-
ments of title I of the Patient Protection Act (as in effect 
as of the date of the enactment of such Act), and such 
requirements shall be deemed to be incorporated into this 
section.’’. 
SEC. 502. CONFORMING ENFORCEMENT FOR WOMEN’S 
HEALTH AND CANCER RIGHTS. 
Subchapter B of chapter 100 of the Internal Revenue 
Code of 1986, as amended by section 501, is further 
amended—
(1) in the table of sections, by inserting after 
the item relating to section 9813 the following new 
item:
‘‘Sec. 9814. Standard relating to women’s health and cancer 
rights.’’;
and
160
(2) by inserting after section 9813 the fol-
lowing: 
‘‘SEC. 9814. STANDARD RELATING TO WOMEN’S HEALTH 
AND CANCER RIGHTS. 
‘‘The provisions of section 713 of the Employee Re-
tirement Income Security Act of 1974 (as in effect as of 
the date of the enactment of this section) shall apply to 
group health plans as if included in this subchapter.’’. 
TITLE 
VI—EFFECTIVE 
DATES; 
COORDINATION 
IN 
IMPLE-
MENTATION 
SEC. 601. EFFECTIVE DATES. 
(a) GROUP HEALTH COVERAGE.—
(1) IN
GENERAL.—Subject to paragraph (2) 
and subsection (d), the amendments made by sec-
tions 201(a), 401, 501, and 502 (and title I insofar 
as it relates to such sections) shall apply with re-
spect to group health plans, and health insurance 
coverage offered in connection with group health 
plans, for plan years beginning on or after October 
1, 2003 (in this section referred to as the ‘‘general 
effective date’’). 
(2) TREATMENT OF COLLECTIVE BARGAINING 
AGREEMENTS.—In the case of a group health plan 
maintained pursuant to one or more collective bar-
161
gaining agreements between employee representa-
tives and one or more employers ratified before the 
date of the enactment of this Act, the amendments 
made by sections 201(a), 401, 501, and 502 (and 
title I insofar as it relates to such sections) shall not 
apply to plan years beginning before the later of—
(A) the date on which the last collective 
bargaining agreements relating to the plan ter-
minates (excluding any extension thereof agreed 
to after the date of the enactment of this Act); 
or 
(B) the general effective date; 
but shall apply not later than 1 year after the gen-
eral effective date. For purposes of subparagraph 
(A), any plan amendment made pursuant to a collec-
tive bargaining agreement relating to the plan which 
amends the plan solely to conform to any require-
ment added by this Act shall not be treated as a ter-
mination of such collective bargaining agreement. 
(b) INDIVIDUAL HEALTH INSURANCE COVERAGE.—
Subject to subsection (d), the amendments made by sec-
tion 202 shall apply with respect to individual health in-
surance coverage offered, sold, issued, renewed, in effect, 
or operated in the individual market on or after the gen-
eral effective date.
164
the first date as of which title I applies to the cov-
erage under such subsection. 
SEC. 602. COORDINATION IN IMPLEMENTATION. 
The Secretary of Labor and the Secretary of Health 
and Human Services shall ensure, through the execution 
of an interagency memorandum of understanding among 
such Secretaries, that—
(1) regulations, rulings, and interpretations 
issued by such Secretaries relating to the same mat-
ter over which such Secretaries have responsibility 
under the provisions of this Act (and the amend-
ments made thereby) are administered so as to have 
the same effect at all times; and 
(2) coordination of policies relating to enforcing 
the same requirements through such Secretaries in 
order to have a coordinated enforcement strategy 
that avoids duplication of enforcement efforts and 
assigns priorities in enforcement. 
SEC. 603. SEVERABILITY. 
If any provision of this Act, an amendment made by 
this Act, or the application of such provision or amend-
ment to any person or circumstance is held to be unconsti-
tutional, the remainder of this Act, the amendments made 
by this Act, and the application of the provisions of such
165
to any person or circumstance shall not be affected there-
by. 
TITLE VII—MISCELLANEOUS 
PROVISIONS 
SEC. 701. NO IMPACT ON SOCIAL SECURITY TRUST FUND. 
(a) IN GENERAL.—Nothing in this Act (or an amend-
ment made by this Act) shall be construed to alter or 
amend the Social Security Act (or any regulation promul-
gated under that Act). 
(b) TRANSFERS.—
(1) ESTIMATE OF SECRETARY.—The Secretary 
of the Treasury shall annually estimate the impact 
that the enactment of this Act has on the income 
and balances of the trust funds established under 
section 201 of the Social Security Act (42 U.S.C. 
401). 
(2) TRANSFER
OF
FUNDS.—If, under para-
graph (1), the Secretary of the Treasury estimates 
that the enactment of this Act has a negative impact 
on the income and balances of the trust funds estab-
lished under section 201 of the Social Security Act 
(42 U.S.C. 401), the Secretary shall transfer, not 
less frequently than quarterly, from the general reve-
nues of the Federal Government an amount suffi-
cient so as to ensure that the income and balances
166
of such trust funds are not reduced as a result of 
the enactment of such Act. 
SEC. 702. SENSE OF CONGRESS WITH RESPECT TO PARTICI-
PATION IN CLINICAL TRIALS AND ACCESS TO 
SPECIALTY CARE. 
(a) FINDINGS.—The Congress finds the following: 
(1) Breast cancer is the most common form of 
cancer among women, excluding skin cancers. 
(2) During 2001, 182,800 new cases of female 
invasive breast cancer will be diagnosed, and 40,800 
women will die from the disease. 
(3) In addition, 1,400 male breast cancer cases 
are projected to be diagnosed, and 400 men will die 
from the disease. 
(4) Breast cancer is the second leading cause of 
cancer death among all women and the leading 
cause of cancer death among women between ages 
40 and 55. 
(5) This year 8,600 children are expected to be 
diagnosed with cancer. 
(6) 1,500 children are expected to die from can-
cer this year. 
(7) There are approximately 333,000 people di-
agnosed with multiple sclerosis in the United States 
and 200 more cases are diagnosed each week.
167
(8) Parkinson’s disease is a progressive disorder 
of the central nervous system affecting 1,000,000 in 
the United States. 
(9) An estimated 198,100 men will be diag-
nosed with prostate cancer this year. 
(10) 31,500 men will die from prostate cancer 
this year. It is the second leading cause of cancer in 
men. 
(11) While information obtained from clinical 
trials is essential to finding cures for diseases, it is 
still research which carries the risk of fatal results. 
Future efforts should be taken to protect the health 
and safety of adults and children who enroll in clin-
ical trials. 
(12) While employers and health plans should 
be responsible for covering the routine costs associ-
ated with federally approved or funded clinical trials, 
such employers and health plans should not be held 
legally responsible for the design, implementation, or 
outcome of such clinical trials, consistent with any 
applicable State or Federal liability statutes. 
(b) SENSE OF THE CONGRESS.—It is the sense of 
the Congress that— 
(1) men and women battling life-threatening, 
deadly diseases, including advanced breast or ovar-
168
ian cancer, should have the opportunity to partici-
pate in a federally approved or funded clinical trial 
recommended by their physician; 
(2) an individual should have the opportunity to 
participate in a federally approved or funded clinical 
trial recommended by their physician if—
(A) that individual—
(i) has a life-threatening or serious ill-
ness for which no standard treatment is ef-
fective; 
(ii) is eligible to participate in a feder-
ally approved or funded clinical trial ac-
cording to the trial protocol with respect to 
treatment of the illness; 
(B) that individual’s participation in the 
trial offers meaningful potential for significant 
clinical benefit for the individual; and 
(C) either—
(i) the referring physician is a partici-
pating health care professional and has 
concluded that the individual’s participa-
tion in the trial would be appropriate, 
based upon the individual meeting the con-
ditions described in subparagraph (A); or
169
(ii) the participant, beneficiary, or en-
rollee provides medical and scientific infor-
mation establishing that the individual’s 
participation in the trial would be appro-
priate, based upon the individual meeting 
the conditions described in subparagraph 
(A); 
(3) a child with a life-threatening illness, in-
cluding cancer, should be allowed to participate in a 
federally approved or funded clinical trial if that 
participation meets the requirements of paragraph 
(2); 
(4) a child with a rare cancer should be allowed 
to go to a cancer center capable of providing high 
quality care for that disease; and 
(5) a health maintenance organization’s deci-
sion that an in-network physician without the nec-
essary expertise can provide care for a seriously ill 
patient, including a woman battling cancer, should 
be appealable to an independent, impartial body, and 
that this same right should be available to all Ameri-
cans in need of access to high quality specialty care. 
SEC. 703. SENSE OF THE CONGRESS REGARDING FAIR RE-
VIEW PROCESS. 
(a) FINDINGS.—The Congress finds the following:
170
(1) A fair, timely, impartial independent exter-
nal appeals process is essential to any meaningful 
program of patient protection. 
(2) The independence and objectivity of the re-
view organization and review process must be en-
sured. 
(3) It is incompatible with a fair and inde-
pendent appeals process to allow a health mainte-
nance organization to select the review organization 
that is entrusted with providing a neutral and unbi-
ased medical review. 
(4) The American Arbitration Association and 
arbitration standards adopted under chapter 44 of 
title 28, United States Code (28 U.S.C. 651 et seq.) 
both prohibit, as inherently unfair, the right of one 
party to a dispute to choose the judge in that dis-
pute. 
(b) SENSE OF THE CONGRESS.—It is the sense of 
the Congress that—
(1) every patient who is denied care by a health 
maintenance organization or other health insurance 
company should be entitled to a fair, speedy, impar-
tial appeal to a review organization that has not 
been selected by the health plan;
171
(2) the States should be empowered to maintain 
and develop the appropriate process for selection of 
the independent external review entity; 
(3) a child battling a rare cancer whose health 
maintenance organization has denied a covered 
treatment recommended by its physician should be 
entitled to a fair and impartial external appeal to a 
review organization that has not been chosen by the 
organization or plan that has denied the care; and 
(4) patient protection legislation should not pre-
empt existing State laws in States where there al-
ready are strong laws in place regarding the selec-
tion of independent review organizations. 
SEC. 704. ANNUAL REVIEW. 
(a) IN GENERAL.—Not later than 24 months after 
the general effective date referred to in section 601(a)(1), 
and annually thereafter for each of the succeeding 4 cal-
endar years (or until a repeal is effective under subsection 
(b)), the Secretary of Health and Human Services shall 
request that the Institute of Medicine of the National 
Academy of Sciences prepare and submit to the appro-
priate committees of Congress a report concerning the im-
pact of this Act, and the amendments made by this Act, 
on the number of individuals in the United States with 
health insurance coverage.
172
(b) FUNDING.—From funds appropriated to the De-
partment of Health and Human Services for fiscal years 
2004 and 2005, the Secretary of Health and Human Serv-
ices shall provide for such funding as the Secretary deter-
mines necessary for the conduct of the study of the Na-
tional Academy of Sciences under this section.
Æ