I
106TH CONGRESS
1ST SESSION
H. R. 2926
To provide new patient protections under group health plans and through
health insurance issuers in the group market.
IN THE HOUSE OF REPRESENTATIVES
SEPTEMBER 23, 1999
Mr. BOEHNER (for himself, Mr. ARMEY, Mr. BLILEY, Mr. GOODLING, Mrs.
NORTHUP, Mr. MCCRERY, Mr. GREEN of Wisconsin, Mr. TALENT, Mr.
OXLEY, Mr. PORTMAN, Mr. HOBSON, Mr. BALLENGER, and Mr. SALM-
ON) introduced the following bill; which was referred to the Committee
on Commerce, and in addition to the Committees on Education and the
Workforce, Ways and Means, and the Judiciary, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such
provisions as fall within the jurisdiction of the committee concerned
A BILL
To provide new patient protections under group health plans
and through health insurance issuers in the group market.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE AND TABLE OF CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Comprehensive Access and Responsibility in Health Care
Act of 1999’’.
(b) TABLE OF CONTENTS.—The table of contents is
as follows:
Sec. 1. Short title and table of contents.
TITLE I—AMENDMENTS TO THE EMPLOYEE RETIREMENT
INCOME SECURITY ACT OF 1974
Subtitle A—Patient Protections
Sec. 101. Patient access to unrestricted medical advice, emergency medical
care, obstetric and gynecological care, pediatric care, and con-
tinuity of care.
Sec. 102. Required disclosure to network providers.
Sec. 103. Effective date and related rules.
Subtitle B—Patient Access to Information
Sec. 111. Patient access to information regarding plan coverage, managed care
procedures, health care providers, and quality of medical care.
Sec. 112. Effective date and related rules.
Subtitle C—Group Health Plan Review Standards
Sec. 121. Special rules for group health plans.
Sec. 122. Special rule for access to specialty care.
Sec. 123. Requirements for treatment of prescription drugs and medical devices
as experimental or investigational.
Sec. 124. Protection for certain information developed to reduce mortality or
morbidity or for improving patient care and safety.
Sec. 125. Effective date.
Subtitle D—Small Business Access and Choice for Entrepreneurs
Sec. 131. Rules governing association health plans.
‘‘PART 8—RULES GOVERNING ASSOCIATION HEALTH PLANS
‘‘Sec. 801. Association health plans.
‘‘Sec. 802. Certification of association health plans.
‘‘Sec. 803. Requirements relating to sponsors and boards of trustees.
‘‘Sec. 804. Participation and coverage requirements.
‘‘Sec. 805. Other requirements relating to plan documents, contribution rates,
and benefit options.
‘‘Sec. 806. Maintenance of reserves and provisions for solvency for plans pro-
viding health benefits in addition to health insurance coverage.
‘‘Sec. 807. Requirements for application and related requirements.
‘‘Sec. 808. Notice requirements for voluntary termination.
‘‘Sec. 809. Corrective actions and mandatory termination.
‘‘Sec. 810. Trusteeship by the secretary of insolvent association health plans
providing health benefits in addition to health insurance cov-
erage.
‘‘Sec. 811. State assessment authority.
‘‘Sec. 812. Definitions and rules of construction.
Sec. 132. Clarification of treatment of single employer arrangements.
Sec. 133. Clarification of treatment of certain collectively bargained arrange-
ments.
Sec. 134. Enforcement provisions relating to association health plans.
Sec. 135. Cooperation between Federal and State authorities.
Sec. 136. Effective date and transitional and other rules.
Subtitle E—Health Care Access, Affordability, and Quality Commission
Sec. 141. Establishment of commission.
Sec. 142. Effective date.
TITLE II—AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT
Subtitle A—Patient Protections and Point of Service Coverage Requirements
Sec. 201. Patient access to unrestricted medical advice, emergency medical
care, obstetric and gynecological care, pediatric care, and con-
tinuity of care.
Sec. 202. Requiring health maintenance organizations to offer option of point-
of-service coverage.
Sec. 203. Effective date and related rules.
Subtitle B—Patient Access to Information
Sec. 211. Patient access to information regarding plan coverage, managed care
procedures, health care providers, and quality of medical care.
Sec. 212. Requirements for treatment of prescription drugs and medical devices
as experimental or investigational.
Sec. 213. Effective date and related rules.
Subtitle C—HealthMarts
Sec. 221. Expansion of consumer choice through HealthMarts.
Sec. 222. Effective date.
Subtitle D—Community Health Organizations
Sec. 231. Promotion of provision of insurance by community health organiza-
tions.
TITLE III—AMENDMENTS TO THE INTERNAL REVENUE CODE OF
1986
Subtitle A—Patient Protections
Sec. 301. Patient access to unrestricted medical advice, emergency medical
care, obstetric and gynecological care, pediatric care, and con-
tinuity of care.
Subtitle B—Medical Savings Accounts
Sec. 311. Expansion of availability of medical savings accounts.
Sec. 312. Effective date.
Subtitle C—Tax Incentives for Health Care
Sec. 321. Deduction for health and long-term care insurance costs of individ-
uals not participating in employer-subsidized health plans.
Sec. 322. Refundable credit for health insurance coverage.
Sec. 323. Study of State safety-net health insurance programs for the medically
uninsurable.
Sec. 324. Carryover of unused benefits from cafeteria plans and flexible spend-
ing arrangements.
TITLE IV—HEALTH CARE LAWSUIT REFORM
Subtitle A—General Provisions
Sec. 401. Federal reform of health care liability actions.
Sec. 402. Definitions.
Sec. 403. Effective date.
Subtitle B—Uniform Standards for Health Care Liability Actions
Sec. 411. Statute of limitations.
Sec. 412. Calculation and payment of damages.
Sec. 413. Limitations on contingent fees.
Sec. 413. Alternative dispute resolution.
Sec. 414. Reporting on fraud and abuse enforcement activities.
TITLE I—AMENDMENTS TO THE
EMPLOYEE RETIREMENT IN-
COME SECURITY ACT OF 1974
Subtitle A—Patient Protections
SEC. 101. PATIENT ACCESS TO UNRESTRICTED MEDICAL
ADVICE, EMERGENCY MEDICAL CARE, OB-
STETRIC AND GYNECOLOGICAL CARE, PEDI-
ATRIC CARE, AND CONTINUITY OF CARE.
(a) IN GENERAL.—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 ACCESS TO UNRESTRICTED MEDICAL
ADVICE, EMERGENCY MEDICAL CARE, OB-
STETRIC AND GYNECOLOGICAL CARE, PEDI-
ATRIC CARE, AND CONTINUITY OF CARE.
‘‘(a) PATIENT ACCESS TO UNRESTRICTED MEDICAL
ADVICE.—
‘‘(1) IN GENERAL.—In the case of any health
care professional acting within the lawful scope of
practice in the course of carrying out a contractual
employment arrangement or other direct contractual
arrangement between such professional and a group
health plan or a health insurance issuer offering
health insurance coverage in connection with a group
health plan, the plan or issuer with which such con-
tractual employment arrangement or other direct
contractual arrangement is maintained by the pro-
fessional may not impose on such professional under
such arrangement any prohibition or restriction with
respect to advice, provided to a participant or bene-
ficiary under the plan who is a patient, about the
health status of the participant or beneficiary or the
medical care or treatment for the condition or dis-
ease of the participant or beneficiary, regardless of
whether benefits for such care or treatment are pro-
vided under the plan or health insurance coverage
offered in connection with the plan.
‘‘(2) HEALTH CARE PROFESSIONAL DEFINED.—
For purposes of this paragraph, the term ‘health
care professional’ means a physician (as defined in
section 1861(r) of the Social Security Act) or other
health care professional if coverage for the profes-
sional’s services is provided under the group health
plan for the services of the professional. Such term
includes a podiatrist, optometrist, chiropractor, psy-
chologist, dentist, physician assistant, physical or oc-
cupational therapist and therapy assistant, speech-
language pathologist, audiologist, registered or li-
censed practical nurse (including nurse practitioner,
clinical nurse specialist, certified registered nurse
anesthetist, and certified nurse-midwife), licensed
certified social worker, registered respiratory thera-
pist, and certified respiratory therapy technician.
‘‘(3) RULE
OF
CONSTRUCTION.—Nothing in
this subsection shall be construed to require the
sponsor of a group health plan or a health insurance
issuer offering health insurance coverage in connec-
tion with the group health plan to engage in any
practice that would violate its religious beliefs or
moral convictions.
‘‘(b) PATIENT ACCESS
TO EMERGENCY MEDICAL
CARE.—
‘‘(1) COVERAGE OF EMERGENCY SERVICES.—
‘‘(A) IN
GENERAL.—If a group health
plan, or health insurance coverage offered by a
health insurance issuer, provides any benefits
with respect to emergency services (as defined
in subparagraph (B)(ii)), or ambulance services,
the plan or issuer shall cover emergency serv-
ices (including emergency ambulance services as
defined in subparagraph (B)(iii)) furnished
under the plan or coverage—
‘‘(i) without the need for any prior
authorization determination;
‘‘(ii) whether or not the health care
provider furnishing such services is a par-
ticipating provider with respect to such
services;
‘‘(iii) in a manner so that, if such
services are provided to a participant or
beneficiary by a nonparticipating health
care provider, the participant or bene-
ficiary is not liable for amounts that ex-
ceed the amounts of liability that would be
incurred if the services were provided by a
participating provider; and
‘‘(iv) without regard to any other term
or condition of such plan or coverage
(other than exclusion or coordination of
benefits, or an affiliation or waiting period,
permitted under section 701 and other
than applicable cost sharing).
‘‘(B) DEFINITIONS.—In this subsection:
‘‘(i) EMERGENCY
MEDICAL
CONDI-
TION.—The term ‘emergency medical con-
dition’ means—
‘‘(I) a medical condition mani-
festing itself by acute symptoms of
sufficient severity (including severe
pain) such that a prudent layperson,
who possesses an average knowledge
of health and medicine, could reason-
ably expect the absence of immediate
medical attention to result in a condi-
tion described in clause (i), (ii), or
(iii) of section 1867(e)(1)(A) of the
Social 
Security 
Act 
(42 
U.S.C.
1395dd(e)(1)(A)); and
‘‘(II) a medical condition mani-
festing itself in a neonate by acute
symptoms of sufficient severity (in-
cluding severe pain) such that a pru-
dent health care professional could
reasonably expect the absence of im-
mediate 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.
‘‘(ii) 
EMERGENCY
SERVICES.—The
term ‘emergency services’ means—
‘‘(I) with respect to an emer-
gency medical condition described in
clause (i)(I), a medical screening ex-
amination (as required under section
1867 of the Social Security Act, 42
U.S.C. 1395dd)) that is within the ca-
pability of the emergency department
of a hospital, including ancillary serv-
ices routinely available to the emer-
gency department to evaluate an
emergency medical condition (as de-
fined in clause (i)) and also, within
the capabilities of the staff and facili-
ties at the hospital, such further med-
ical examination and treatment as are
required under section 1867 of such
Act to stabilize the patient; or
‘‘(II) with respect to an emer-
gency medical condition described in
clause (i)(II), medical treatment for
such condition rendered by a health
care provider in a hospital to a
neonate, including available hospital
ancillary services in response to an ur-
gent request of a health care profes-
sional and to the extent necessary to
stabilize the neonate.
‘‘(iii) EMERGENCY AMBULANCE SERV-
ICES.—The term ‘emergency ambulance
services’ means ambulance services (as de-
fined for purposes of section 1861(s)(7) of
the Social Security Act) furnished to trans-
port an individual who has an emergency
medical condition (as defined in clause (i))
to a hospital for the receipt of emergency
services (as defined in clause (ii)) in a case
in which appropriate emergency medical
screening examinations are covered under
the plan or coverage pursuant to para-
graph (1)(A) 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 seri-
ous jeopardy, serious impairment of bodily
function, or serious dysfunction of any
bodily organ or part.
‘‘(iv) STABILIZE.—The term ‘to sta-
bilize’ means, with respect to an emergency
medical condition, to provide such medical
treatment of the condition as may be nec-
essary to assure, within reasonable medical
probability, that no material deterioration
of the condition is likely to result from or
occur during the transfer of the individual
from a facility.
‘‘(v) NONPARTICIPATING.—The term
‘nonparticipating’ means, with respect to a
health care provider that provides health
care items and services to a participant or
beneficiary under group health plan or
under group health insurance coverage, a
health care provider that is not a partici-
pating health care provider with respect to
such items and services.
‘‘(vi) 
PARTICIPATING.—The 
term
‘participating’ means, with respect to a
health care provider that provides health
care items and services to a participant or
beneficiary under group health plan or
health insurance coverage offered by a
health insurance issuer in connection with
such a plan, a health care provider that
furnishes such items and services under a
contract or other arrangement with the
plan or issuer.
‘‘(c) PATIENT RIGHT TO OBSTETRIC AND GYNECO-
LOGICAL CARE.—
‘‘(1) IN
GENERAL.—In any case in which a
group health plan (or a health insurance issuer of-
fering health insurance coverage in connection with
the plan)—
‘‘(A) provides benefits under the terms of
the plan consisting of—
‘‘(i) gynecological care (such as pre-
ventive women’s health examinations); or
‘‘(ii) obstetric care (such as preg-
nancy-related services),
provided by a participating health care profes-
sional who specializes in such care (or provides
benefits consisting of payment for such care);
and
‘‘(B) requires or provides for designation
by a participant or beneficiary of a partici-
pating primary care provider,
if the primary care provider designated by such a
participant or beneficiary is not such a health care
professional, then the plan (or issuer) shall meet the
requirements of paragraph (2).
‘‘(2) REQUIREMENTS.—A group health plan (or
a health insurance issuer offering health insurance
coverage in connection with the plan) meets the re-
quirements of this paragraph, in connection with
benefits described in paragraph (1) consisting of
care described in clause (i) or (ii) of paragraph
(1)(A) (or consisting of payment therefor), if the
plan (or issuer)—
‘‘(A) does not require authorization or a
referral by the primary care provider in order
to obtain such benefits; and
‘‘(B) treats the ordering of other care of
the same type, by the participating health care
professional providing the care described in
clause (i) or (ii) of paragraph (1)(A), as the au-
thorization of the primary care provider with
respect to such care.
‘‘(3) HEALTH CARE PROFESSIONAL DEFINED.—
For purposes of this subsection, the term ‘health
care professional’ means an individual (including,
but not limited to, a nurse midwife or nurse practi-
tioner) who is licensed, accredited, or certified under
State law to provide obstetric and gynecological
health care services and who is operating within the
scope of such licensure, accreditation, or certifi-
cation.
‘‘(4) CONSTRUCTION.—Nothing in paragraph
(1) shall be construed as preventing a plan from of-
fering (but not requiring a participant or beneficiary
to accept) a health care professional trained,
credentialed, and operating within the scope of their
licensure to perform obstetric and gynecological
health care services. Nothing in paragraph (2)(B)
shall waive any requirements of coverage relating to
medical necessity or appropriateness with respect to
coverage of gynecological or obstetric care so or-
dered.
‘‘(5) TREATMENT OF MULTIPLE COVERAGE OP-
TIONS.—In the case of a plan providing benefits
under two or more coverage options, the require-
ments of this subsection shall apply separately with
respect to each coverage option.
‘‘(d) PATIENT RIGHT TO PEDIATRIC CARE.—
‘‘(1) IN
GENERAL.—In any case in which a
group health plan (or a health insurance issuer of-
fering health insurance coverage in connection with
the plan) provides benefits consisting of routine pe-
diatric care provided by a participating health care
professional who specializes in pediatrics (or con-
sisting of payment for such care) and the plan re-
quires or provides for designation by a participant or
beneficiary of a participating primary care provider,
the plan (or issuer) shall provide that such a partici-
pating health care professional may be designated, if
available, by a parent or guardian of any beneficiary
under the plan is who under 18 years of age, as the
primary care provider with respect to any such bene-
fits.
‘‘(2) HEALTH CARE PROFESSIONAL DEFINED.—
For purposes of this subsection, the term ‘health
care professional’ means an individual (including,
but not limited to, a nurse practitioner) who is li-
censed, accredited, or certified under State law to
provide pediatric health care services and who is op-
erating within the scope of such licensure, accredita-
tion, or certification.
‘‘(3) CONSTRUCTION.—Nothing in paragraph
(1) shall be construed as preventing a plan from of-
fering (but not requiring a participant or beneficiary
to accept) a health care professional trained,
credentialed, and operating within the scope of their
licensure to perform pediatric health care services.
Nothing in paragraph (1) shall waive any require-
ments of coverage relating to medical necessity or
appropriateness with respect to coverage of pediatric
care so ordered.
‘‘(4) TREATMENT OF MULTIPLE COVERAGE OP-
TIONS.—In the case of a plan providing benefits
under two or more coverage options, the require-
ments of this subsection shall apply separately with
respect to each coverage option.
‘‘(e) CONTINUITY OF CARE.—
‘‘(1) IN GENERAL.—
‘‘(A) TERMINATION
OF
PROVIDER.—If a
contract between a group health plan, or a
health insurance issuer offering health insur-
ance coverage in connection with a group health
plan, and a health care provider is terminated
(as defined in subparagraph (D)(ii)), or benefits
or coverage provided by a health care provider
are terminated because of a change in the
terms of provider participation in a group
health plan, and an individual who, at the time
of such termination, is a participant or bene-
ficiary in the plan and is scheduled to undergo
surgery (including an organ transplantation), is
undergoing treatment for pregnancy, or is de-
termined to be terminally ill (as defined in sec-
tion 1861(dd)(3)(A) of the Social Security Act)
and is undergoing treatment for the terminal
illness, the plan or issuer shall—
‘‘(i) notify the individual on a timely
basis of such termination and of the right
to elect continuation of coverage of treat-
ment by the provider under this sub-
section; and
‘‘(ii) subject to paragraph (3), permit
the individual to elect to continue to be
covered with respect to treatment by the
provider for such surgery, pregnancy, or
illness during a transitional period (pro-
vided under paragraph (2)).
‘‘(B) TREATMENT
OF
TERMINATION
OF
CONTRACT
WITH
HEALTH
INSURANCE
ISSUER.—If a contract for the provision of
health insurance coverage between a group
health plan and a health insurance issuer is ter-
minated 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 subparagraph (A) (and the suc-
ceeding provisions of this subsection) shall
apply under the plan in the same manner as
if there had been a contract between the plan
and the provider that had been terminated, but
only with respect to benefits that are covered
under the plan after the contract termination.
‘‘(C) TERMINATION
DEFINED.—For pur-
poses of this subsection, the term ‘terminated’
includes, with respect to a contract, the expira-
tion or nonrenewal of the contract, but does not
include a termination of the contract by the
plan or issuer for failure to meet applicable
quality standards or for fraud.
‘‘(2) TRANSITIONAL PERIOD.—
‘‘(A) IN GENERAL.—Except as provided in
subparagraphs (B) through (D), the transi-
tional period under this paragraph shall extend
up to 90 days (as determined by the treating
health care professional) after the date of the
notice described in paragraph (1)(A)(i) of the
provider’s termination.
‘‘(B) SCHEDULED
SURGERY.—If surgery
was scheduled for an individual before the date
of the announcement of the termination of the
provider status under paragraph (1)(A)(i), the
transitional period under this paragraph with
respect to the surgery shall extend beyond the
period under subparagraph (A) and until the
date of discharge of the individual after comple-
tion of the surgery.
‘‘(C) PREGNANCY.—If—
‘‘(i) a participant or beneficiary was
determined to be pregnant at the time of
a provider’s termination of participation,
and
‘‘(ii) the provider was treating the
pregnancy before date of the termination,
the transitional period under this paragraph
with respect to provider’s treatment of the
pregnancy shall extend through the provision of
post-partum care directly related to the deliv-
ery.
‘‘(D) TERMINAL ILLNESS.—If—
‘‘(i) a participant or beneficiary was
determined to be terminally ill (as deter-
mined under section 1861(dd)(3)(A) of the
Social Security Act) at the time of a pro-
vider’s termination of participation, and
‘‘(ii) the provider was treating the ter-
minal illness before the date of termi-
nation,
the transitional period under this paragraph
shall extend for the remainder of the individ-
ual’s life for care directly related to the treat-
ment of the terminal illness or its medical
manifestations.
‘‘(3) PERMISSIBLE TERMS AND CONDITIONS.—
A group health plan or health insurance issuer may
condition coverage of continued treatment by a pro-
vider under paragraph (1)(A)(i) upon the individual
notifying the plan of the election of continued cov-
erage and upon the provider agreeing to the fol-
lowing terms and conditions:
‘‘(A) The provider agrees to accept reim-
bursement from the plan or issuer and indi-
vidual 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 paragraph (1)(B), at the rates
applicable under the replacement plan or issuer
after the date of the termination of the contract
with the health insurance issuer) and not to im-
pose cost-sharing with respect to the individual
in an amount that would exceed the cost-shar-
ing that could have been imposed if the contract
referred to in paragraph (1)(A) had not been
terminated.
‘‘(B) The provider agrees to adhere to the
quality assurance standards of the plan or
issuer responsible for payment under subpara-
graph (A) and to provide to such plan or issuer
necessary medical information related to the
care provided.
‘‘(C) The provider agrees otherwise to ad-
here to such plan’s or issuer’s policies and pro-
cedures, including procedures regarding refer-
rals and obtaining prior authorization and pro-
viding services pursuant to a treatment plan (if
any) approved by the plan or issuer.
‘‘(D) The provider agrees to provide tran-
sitional care to all participants and beneficiaries
who are eligible for and elect to have coverage
of such care from such provider.
‘‘(E) If the provider initiates the termi-
nation, the provider has notified the plan within
30 days prior to the effective date of the termi-
nation of—
‘‘(i) whether the provider agrees to
permissible terms and conditions (as set
forth in this paragraph) required by the
plan, and
‘‘(ii) if the provider agrees to the
terms and conditions, the specific plan
beneficiaries and participants undergoing a
course of treatment from the provider who
the provider believes, at the time of the no-
tification, would be eligible for transitional
care under this subsection.
‘‘(4) CONSTRUCTION.—Nothing in this sub-
section shall be construed to—
‘‘(A) require the coverage of benefits which
would not have been covered if the provider in-
volved remained a participating provider, or
‘‘(B) prohibit a group health plan from
conditioning a provider’s participation on the
provider’s agreement to provide transitional
care to all participants and beneficiaries eligible
to obtain coverage of such care furnished by the
provider as set forth under this subsection.
‘‘(f) COVERAGE FOR INDIVIDUALS PARTICIPATING IN
APPROVED CANCER CLINICAL TRIALS.—
‘‘(1) COVERAGE.—
‘‘(A) IN GENERAL.—If a group health plan
(or a health insurance issuer offering health in-
surance coverage in connection with the plan)
provides coverage to a qualified individual (as
defined in paragraph (2)), the plan or issuer—
‘‘(i) may not deny the individual par-
ticipation in the clinical trial referred to in
paragraph (2)(B);
‘‘(ii) subject to paragraphs (2), (3),
and (4), may not deny (or limit or impose
additional conditions on) the coverage of
routine patient costs for items and services
furnished in connection with participation
in the trial; and
‘‘(iii) may not discriminate against the
individual on the basis of the participation
of the participant or beneficiary in such
trial.
‘‘(B) EXCLUSION
OF
CERTAIN
COSTS.—
For purposes of subparagraph (A)(ii), routine
patient costs do not include the cost of the tests
or measurements conducted primarily for the
purpose of the clinical trial involved.
‘‘(C) USE OF IN-NETWORK PROVIDERS.—If
one or more participating providers is partici-
pating in a clinical trial, nothing in subpara-
graph (A) shall be construed as preventing a
plan from requiring that a qualified individual
participate in the trial through such a partici-
pating provider if the provider will accept the
individual as a participant in the trial.
‘‘(2) QUALIFIED
INDIVIDUAL
DEFINED.—For
purposes of paragraph (1), the term ‘qualified indi-
vidual’ means an individual who is a participant or
beneficiary in a group health plan and who meets
the following conditions:
‘‘(A)(i) The individual has been diagnosed
with cancer.
‘‘(ii) The individual is eligible to partici-
pate in an approved clinical trial according to
the trial protocol with respect to treatment of
cancer.
‘‘(iii) The individual’s participation in the
trial offers meaningful potential for significant
clinical benefit for the individual.
‘‘(B) Either—
‘‘(i) the referring physician is a par-
ticipating health care professional and has
concluded that the individual’s participa-
tion in such trial would be appropriate
based upon satisfaction by the individual of
the conditions described in subparagraph
(A); or
‘‘(ii) the individual provides medical
and scientific information establishing that
the individual’s participation in such trial
would be appropriate based upon the satis-
faction by the individual of the conditions
described in subparagraph (A).
‘‘(3) PAYMENT.—
‘‘(A) IN GENERAL.—A group health plan
(or a health insurance issuer offering health in-
surance coverage in connection with the plan)
shall provide for payment for routine patient
costs described in paragraph (1)(B) but is not
required to pay for costs of items and services
that are reasonably expected to be paid for by
the sponsors of an approved clinical trial.
‘‘(B) ROUTINE PATIENT CARE COSTS.—
‘‘(i) IN
GENERAL.—For purposes of
this paragraph, the term ‘routine patient
care costs’ shall include the costs associ-
ated with the provision of items and serv-
ices that—
‘‘(I) would otherwise be covered
under the group health plan if such
items and services were not provided
in connection with an approved clin-
ical trial program; and
‘‘(II) are furnished according to
the protocol of an approved clinical
trial program.
‘‘(ii) EXCLUSION.—For purposes of
this paragraph, ‘routine patient care costs’
shall not include the costs associated with
the provision of—
‘‘(I) an investigational drug or
device, unless the Secretary has au-
thorized the manufacturer of such
drug or device to charge for such drug
or device; or
‘‘(II) any item or service supplied
without charge by the sponsor of the
approved clinical trial program.
‘‘(C) PAYMENT
RATE.—For purposes of
this subsection—
‘‘(i) PARTICIPATING
PROVIDERS.—In
the case of covered items and services pro-
vided by a participating provider, the pay-
ment rate shall be at the agreed upon rate.
‘‘(ii) 
NONPARTICIPATING
PRO-
VIDERS.—In the case of covered items and
services provided by a nonparticipating
provider, the payment rate shall be at the
rate the plan would normally pay for com-
parable items or services under clause (i).
‘‘(4) APPROVED CLINICAL TRIAL DEFINED.—
‘‘(A) IN GENERAL.—For purposes of this
subsection, the term ‘approved clinical trial’
means a cancer clinical research study or can-
cer clinical investigation approved by an Institu-
tional Review Board.
‘‘(B) CONDITIONS
FOR
DEPARTMENTS.—
The conditions described in this paragraph, for
a study or investigation conducted by a Depart-
ment, are that the study or investigation has
been reviewed and approved through a system
of peer review that the Secretary determines—
‘‘(i) to be comparable to the system of
peer review of studies and investigations
used by the National Institutes of Health,
and
‘‘(ii) assures unbiased review of the
highest scientific standards by qualified in-
dividuals who have no interest in the out-
come of the review.
‘‘(5) CONSTRUCTION.—Nothing in this sub-
section shall be construed to limit a plan’s coverage
with respect to clinical trials.
‘‘(6) PLAN
SATISFACTION
OF
CERTAIN
RE-
QUIREMENTS; RESPONSIBILITIES OF FIDUCIARIES.—
‘‘(A) IN GENERAL.—For purposes of this
subsection, insofar as a group health plan pro-
vides benefits in the form of health insurance
coverage through a health insurance issuer, the
plan shall be treated as meeting the require-
ments of this subsection with respect to such
benefits and not be considered as failing to
meet such requirements because of a failure of
the issuer to meet such requirements so long as
the plan sponsor or its representatives did not
cause such failure by the issuer.
‘‘(B) CONSTRUCTION.—Nothing in this
subsection shall be construed to affect or mod-
ify the responsibilities of the fiduciaries of a
group health plan under part 4.
‘‘(7) STUDY AND REPORT.—
‘‘(A) STUDY.—The Secretary shall analyze
cancer clinical research and its cost implications
for managed care, including differentiation in—
‘‘(i) the cost of patient care in trials
versus standard care;
‘‘(ii) the cost effectiveness achieved in
different sites of service;
‘‘(iii) research outcomes;
‘‘(iv) volume of research subjects
available in different sites of service;
‘‘(v) access to research sites and clin-
ical trials by cancer patients;
‘‘(vi) patient cost sharing or copay-
ment costs realized in different sites of
service;
‘‘(vii) health outcomes experienced in
different sites of service;
‘‘(viii) long term health care services
and costs experienced in different sites of
service;
‘‘(ix) morbidity and mortality experi-
enced in different sites of service; and
‘‘(x) patient satisfaction and pref-
erence of sites of service.
‘‘(B) REPORT
TO
CONGRESS.—Not later
than January 1, 2005, the Secretary shall sub-
mit a report to Congress that contains—
‘‘(i) an assessment of any incremental
cost to group health plans resulting from
the provisions of this section;
‘‘(ii) a projection of expenditures to
such plans resulting from this section;
‘‘(iii) an assessment of any impact on
premiums resulting from this section; and
‘‘(iv) recommendations regarding ac-
tion on other diseases.’’.
(b) CONFORMING AMENDMENT.—The table of con-
tents in section 1 of such Act is amended by adding at
the end of the items relating to subpart B of part 7 of
subtitle B of title I of such Act the following new item:
‘‘Sec. 714. Patient access to unrestricted medical advice, emergency medical
care, obstetric and gynecological care, pediatric care, and con-
tinuity of care.’’.
SEC. 102. REQUIRED DISCLOSURE TO NETWORK PRO-
VIDERS.
(a) IN GENERAL.—Subpart B of part 7 of subtitle
B of title I of the Employee Retirement Income Security
Act of 1974 (as amended by section 101) is amended fur-
ther by adding at the end the following new section:
‘‘SEC. 715. REQUIRED DISCLOSURE TO NETWORK PRO-
VIDERS.
‘‘(a) IN GENERAL.—If a group health plan reim-
burses, through a contract or other arrangement, a health
care provider at a discounted payment rate because the
provider participates in a provider network, the plan shall
disclose to the provider the following information before
the provider furnishes covered items or services under the
plan:
‘‘(1) The identity of the plan sponsor or other
entity that is to utilize the discounted payment rates
in reimbursing network providers in that network.
‘‘(2) The existence of any substantial benefit
differentials established for the purpose of actively
encouraging participants or beneficiaries under the
plan to utilize the providers in that network.
‘‘(3) The methods and materials by which pro-
viders in the network are identified to such partici-
pants or beneficiaries as part of the network.
‘‘(b) PERMITTED MEANS OF DISCLOSURE.—Disclo-
sure required under subsection (a) by a plan may be
made—
‘‘(1) by another entity under a contract or
other arrangement between the plan and the entity;
and
‘‘(2) by making such information available in
written format, in an electronic format, on the Inter-
net, or on a proprietary computer network which is
readily accessible to the network providers.
‘‘(c) CONSTRUCTION.—Nothing in this section shall
be construed to require, directly or indirectly, disclosure
of specific fee arrangements or other reimbursement
arrangements—
‘‘(1) between (i) group health plans or provider
networks and (ii) health care providers, or
‘‘(2) among health care providers.
‘‘(d) DEFINITIONS.—For purposes of this subsection:
‘‘(1) BENEFIT DIFFERENTIAL.—The term ‘ben-
efit differential’ means, with respect to a group
health plan, differences in the case of any partici-
pant or beneficiary, in the financial responsibility for
payment of coinsurance, copayments, deductibles,
balance billing requirements, or any other charge,
based upon whether a health care provider from
whom covered items or services are obtained is a
network provider.
‘‘(2) DISCOUNTED PAYMENT RATE.—The term
‘discounted payment rate’ means, with respect to a
provider, a payment rate that is below the charge
imposed by the provider.
‘‘(3) NETWORK PROVIDER.—The term ‘network
provider’ means, with respect to a group health plan,
a health care provider that furnishes health care
items and services to participants or beneficiaries
under the plan pursuant to a contract or other ar-
rangement with a provider network in which the pro-
vider is participating.
‘‘(4) PROVIDER NETWORK.—The term ‘provider
network’ means, with respect to a group health plan
offering health insurance coverage, an association of
network providers through whom the plan provides,
through contract or other arrangement, health care
items and services to participants and bene-
ficiaries.’’.
(b) CONFORMING AMENDMENT.—The table of con-
tents in section 1 of such Act is amended by adding at
the end of the items relating to subpart B of part 7 of
subtitle B of title I of such Act the following new item:
‘‘Sec. 715. Required disclosure to network providers.’’.
SEC. 103. EFFECTIVE DATE AND RELATED RULES.
(a) IN GENERAL.—The amendments made by this
subtitle shall apply with respect to plan years beginning
on or after January 1 of the second calendar year fol-
lowing the date of the enactment of this Act, except that
the Secretary of Labor may issue regulations before such
date under such amendments. The Secretary shall first
issue regulations necessary to carry out the amendments
made by this subtitle before the effective date thereof.
(b) LIMITATION ON ENFORCEMENT ACTIONS.—No
enforcement action shall be taken, pursuant to the amend-
ments made by this subtitle, against a group health plan
or health insurance issuer with respect to a violation of
a requirement imposed by such amendments before the
date of issuance of regulations issued in connection with
such requirement, if the plan or issuer has sought to com-
ply in good faith with such requirement.
(c) SPECIAL RULE FOR COLLECTIVE BARGAINING
AGREEMENTS.—In the case of a group health plan main-
tained pursuant to one or more collective bargaining
agreements between employee representatives and one or
more employers ratified before the date of the enactment
of this Act, the amendments made by this subtitle shall
not apply with respect to plan years beginning before the
later of—
(1) the date on which the last of the collective
bargaining agreements relating to the plan termi-
nates (determined without regard to any extension
thereof agreed to after the date of the enactment of
this Act); or
(2) January 1, 2002.
For purposes of this subsection, any plan amendment
made pursuant to a collective bargaining agreement relat-
ing to the plan which amends the plan solely to conform
to any requirement added by this subtitle shall not be
treated as a termination of such collective bargaining
agreement.
Subtitle B—Patient Access to
Information
SEC. 111. PATIENT ACCESS TO INFORMATION REGARDING
PLAN COVERAGE, MANAGED CARE PROCE-
DURES, 
HEALTH 
CARE 
PROVIDERS, 
AND
QUALITY OF MEDICAL CARE.
(a) IN GENERAL.—Part 1 of subtitle B of title I of
the Employee Retirement Income Security Act of 1974 is
amended—
(1) by redesignating section 111 as section 112;
and
(2) by inserting after section 110 the following
new section:
‘‘DISCLOSURE BY GROUP HEALTH PLANS
‘‘SEC. 111. (a) DISCLOSURE REQUIREMENT.—The
administrator of each group health plan shall take such
actions as are necessary to ensure that the summary plan
description of the plan required under section 102 (or each
summary plan description in any case in which different
summary plan descriptions are appropriate under part 1
for different options of coverage) contains, among any in-
formation otherwise required under this part, the informa-
tion required under subsections (b), (c), (d), and
(e)(2)(A).
‘‘(b) PLAN BENEFITS.—The information required
under subsection (a) includes the following:
‘‘(1) COVERED ITEMS AND SERVICES.—
‘‘(A) CATEGORIZATION OF INCLUDED BEN-
EFITS.—A description of covered benefits, cat-
egorized by—
‘‘(i) types of items and services (in-
cluding any special disease management
program); and
‘‘(ii) types of health care professionals
providing such items and services.
‘‘(B) EMERGENCY MEDICAL CARE.—A de-
scription of the extent to which the plan covers
emergency medical care (including the extent to
which the plan provides for access to urgent
care centers), and any definitions provided
under the plan for the relevant plan termi-
nology referring to such care.
‘‘(C) PREVENTATIVE
SERVICES.—A de-
scription of the extent to which the plan pro-
vides benefits for preventative services.
‘‘(D) DRUG FORMULARIES.—A description
of the extent to which covered benefits are de-
termined by the use or application of a drug
formulary and a summary of the process for de-
termining what is included in such formulary.
‘‘(E) 
COBRA 
CONTINUATION
COV-
ERAGE.—A description of the benefits available
under the plan pursuant to part 6.
‘‘(2) LIMITATIONS, EXCLUSIONS, AND RESTRIC-
TIONS ON COVERED BENEFITS.—
‘‘(A) 
CATEGORIZATION
OF
EXCLUDED
BENEFITS.—A description of benefits specifi-
cally excluded from coverage, categorized by
types of items and services.
‘‘(B) 
UTILIZATION
REVIEW
AND
PREAUTHORIZATION REQUIREMENTS.—Whether
coverage for medical care is limited or excluded
on 
the 
basis 
of 
utilization 
review 
or
preauthorization requirements.
‘‘(C) LIFETIME, ANNUAL, OR OTHER PE-
RIOD LIMITATIONS.—A description of the cir-
cumstances under which, and the extent to
which, coverage is subject to lifetime, annual,
or other period limitations, categorized by types
of benefits.
‘‘(D) CUSTODIAL CARE.—A description of
the circumstances under which, and the extent
to which, the coverage of benefits for custodial
care is limited or excluded, and a statement of
the definition used by the plan for custodial
care.
‘‘(E) 
EXPERIMENTAL
TREATMENTS.—
Whether coverage for any medical care is lim-
ited or excluded because it constitutes an inves-
tigational item or experimental treatment or
technology, and any definitions provided under
the plan for the relevant plan terminology refer-
ring to such limited or excluded care.
‘‘(F) MEDICAL APPROPRIATENESS OR NE-
CESSITY.—Whether coverage for medical care
may be limited or excluded by reason of a fail-
ure to meet the plan’s requirements for medical
appropriateness or necessity, and any defini-
tions provided under the plan for the relevant
plan terminology referring to such limited or
excluded care.
‘‘(G) SECOND
OR
SUBSEQUENT
OPIN-
IONS.—A description of the circumstances
under which, and the extent to which, coverage
for second or subsequent opinions is limited or
excluded.
‘‘(H) SPECIALTY CARE.—A description of
the circumstances under which, and the extent
to which, coverage of benefits for specialty care
is conditioned on referral from a primary care
provider.
‘‘(I) CONTINUITY OF CARE.—A description
of the circumstances under which, and the ex-
tent to which, coverage of items and services
provided by any health care professional is lim-
ited or excluded by reason of the departure by
the professional from any defined set of pro-
viders.
‘‘(J) RESTRICTIONS
ON
COVERAGE
OF
EMERGENCY
SERVICES.—A description of the
circumstances under which, and the extent to
which, the plan, in covering emergency medical
care furnished to a participant or beneficiary of
the plan imposes any financial responsibility de-
scribed in subsection (c) on participants or
beneficiaries or limits or conditions benefits for
‘‘(II) an independent contract ex-
pert finds under subparagraph (C), in
advance of any review of the decision
under subparagraph (D), that such
determination primarily requires the
evaluation of medical facts or medical
evidence by a health professional.
‘‘(iii) MATTERS
SPECIFICALLY
NOT
SUBJECT TO REVIEW.—The requirements
of subparagraphs (B), (C), (D), and (E)
shall not apply in the case of any adverse
coverage decision if such decision is based
on—
‘‘(I) a determination of eligibility
for benefits,
‘‘(II) the application of explicit
plan limits on the number, cost, or
duration of any benefit, or
‘‘(III) a limitation on the amount
of any benefit payment or a require-
ment to make copayments under the
terms of the plan.
Review under this paragraph shall not be avail-
able for any coverage decision that has pre-
viously undergone review under this paragraph.