I
105TH CONGRESS
2D SESSION
H. R. 3605
To amend the Public Health Service Act, the Employee Retirement Income
Security Act of 1974, and the Internal Revenue Code of 1986 to protect
consumers in managed care plans and other health coverage.
IN THE HOUSE OF REPRESENTATIVES
MARCH 31, 1998
Mr. DINGELL (for himself, Mr. GEPHARDT, Mr. BROWN of Ohio, Mr. RAN-
GEL, Mr. STARK, Mr. CLAY, Mr. PAYNE, Mr. FAZIO of California, Mr.
WAXMAN, Mr. ABERCROMBIE, Mr. ALLEN, Mr. ANDREWS, Mr. BAESLER,
Mr. BENTSEN, Mr. BERMAN, Mr. BOSWELL, Mr. BOUCHER, Ms. BROWN
of Florida, Mr. BROWN of California, Mrs. CAPPS, Mr. CARDIN, Ms. CAR-
SON, Ms. CHRISTIAN-GREEN, Mrs. CLAYTON, Mr. CLEMENT, Mr. COYNE,
Mr. CUMMINGS, Ms. DEGETTE, Mr. DELAHUNT, Ms. DELAURO, Ms.
ESHOO, Mr. EVANS, Mr. FILNER, Mr. FORD, Mr. FRANK of Massachu-
setts, Mr. FROST, Ms. FURSE, Mr. GEJDENSON, Mr. GREEN, Mr.
HASTINGS of Florida, Mr. HILLIARD, Mr. HINCHEY, Mr. HOYER, Mr.
JACKSON of Illinois, Ms. JACKSON-LEE of Texas, Ms. EDDIE BERNICE
JOHNSON of Texas, Ms. KAPTUR, Mr. KENNEDY of Massachusetts, Mrs.
KENNELLY of Connecticut, Mr. KLINK, Mr. LAFALCE, Mr. LANTOS, Mr.
LEWIS of Georgia, Ms. LOFGREN, Mrs. MALONEY of New York, Mr.
MANTON, Mr. MARKEY, Mr. MARTINEZ, Mr. MATSUI, Ms. MCCARTHY of
Missouri, Mr. MCGOVERN, Ms. MCKINNEY, Mrs. MEEK of Florida, Mr.
MENENDEZ, Mr. MILLER of California, Mr. MINGE, Mr. NADLER, Ms.
NORTON, Mr. OLVER, Mr. OWENS, Mr. PALLONE, Mr. PASCRELL, Ms.
PELOSI, Mr. PETERSON of Minnesota, Mr. RAHALL, Ms. RIVERS, Mr.
ROMERO-BARCELO´, Mr. SANDLIN, Mr. ROTHMAN, Mr. RUSH, Mr. SABO,
Mr. SANDERS, Mr. SAWYER, Mr. SERRANO, Ms. STABENOW, Mr. STRICK-
LAND, Mr. STUPAK, Mr. THOMPSON, Mrs. THURMAN, Mr. TOWNS, Ms.
VELA´ZQUEZ, Mr. VENTO, Mr. WEXLER, Mr. WEYGAND, Mr. WISE, Ms.
WOOLSEY, Mr. WYNN, and Mr. YATES) introduced the following bill;
which was referred to the Committee on Commerce, and in addition to
the Committees on Ways and Means, and Education and the Workforce,
for a period to be subsequently determined by the Speaker, in each case
for consideration of such provisions as fall within the jurisdiction of the
committee concerned
A BILL
To amend the Public Health Service Act, the Employee Re-
tirement Income Security Act of 1974, and the Internal
Revenue Code of 1986 to protect consumers in managed
care plans and other health coverage.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Patients’ Bill of Rights Act of 1998’’.
(b) TABLE OF CONTENTS.—The table of contents of
this Act is as follows:
Sec. 1. Short title; table of contents.
TITLE I—HEALTH INSURANCE BILL OF RIGHTS
Subtitle A—Access to Care
Sec. 101. Access to emergency care.
Sec. 102. Offering of choice of coverage options under group health plans.
Sec. 103. Choice of providers.
Sec. 104. Access to specialty care.
Sec. 105. Continuity of care.
Sec. 106. Coverage for individuals participating in approved clinical trials.
Sec. 107. Access to needed prescription drugs.
Sec. 108. Adequacy of provider network.
Sec. 109. Nondiscrimination in delivery of services.
Subtitle B—Quality Assurance
Sec. 111. Internal quality assurance program.
Sec. 112. Collection of standardized data.
Sec. 113. Process for selection of providers.
Sec. 114. Drug utilization program.
Sec. 115. Standards for utilization review activities.
Sec. 116. Health Care Quality Advisory Board.
Subtitle C—Patient Information
Sec. 121. Patient information.
Sec. 122. Protection of patient confidentiality.
Sec. 123. Health insurance ombudsmen.
Subtitle D—Grievance and Appeals Procedures
Sec. 131. Establishment of grievance process.
Sec. 132. Internal appeals of adverse determinations.
Sec. 133. External appeals of adverse determinations.
Subtitle E—Protecting the Doctor-Patient Relationship
Sec. 141. Prohibition of interference with certain medical communications.
Sec. 142. Prohibition against transfer of indemnification or improper incentive
arrangements.
Sec. 143. Additional rules regarding participation of health care professionals.
Sec. 144. Protection for patient advocacy.
Subtitle F—Promoting Good Medical Practice
Sec. 151. Promoting good medical practice.
Sec. 152. Standards relating to benefits for certain breast cancer treatment.
Sec. 153. Standards relating to benefits for reconstructive breast surgery.
Subtitle G—Definitions
Sec. 191. Definitions.
Sec. 192. Preemption; State flexibility; construction.
Sec. 193. Regulations.
TITLE II—APPLICATION OF PATIENT PROTECTION STANDARDS
TO GROUP HEALTH PLANS AND HEALTH INSURANCE COV-
ERAGE UNDER PUBLIC HEALTH SERVICE ACT
Sec. 201. Application to group health plans and group health insurance cov-
erage.
Sec. 202. Application to individual health insurance coverage.
TITLE III—AMENDMENTS TO THE EMPLOYEE RETIREMENT
INCOME SECURITY ACT OF 1974
Sec. 301. Application of patient protection standards to group health plans and
group health insurance coverage under the Employee Retire-
ment Income Security Act of 1974.
Sec. 302. ERISA preemption not to apply to certain actions involving health in-
surance policyholders.
TITLE IV—APPLICATION TO GROUP HEALTH PLANS UNDER THE
INTERNAL REVENUE CODE OF 1986
Sec. 401. Amendments to the Internal Revenue Code of 1986.
TITLE V—EFFECTIVE DATES; COORDINATION IN
IMPLEMENTATION
Sec. 501. Effective dates.
Sec. 502. Coordination in implementation.
TITLE I—HEALTH INSURANCE
BILL OF RIGHTS
Subtitle A—Access to Care
SEC. 101. ACCESS TO EMERGENCY CARE.
(a) COVERAGE OF EMERGENCY SERVICES.—
(1) IN GENERAL.—If a group health plan, or
health insurance coverage offered by a health insur-
ance issuer, provides any benefits with respect to
emergency services (as defined in paragraph (2)(B)),
the plan or issuer shall cover emergency services fur-
nished under the plan or coverage—
(A) without the need for any prior author-
ization determination;
(B) whether or not the health care pro-
vider furnishing such services is a participating
provider with respect to such services;
(C) in a manner so that, if such services
are provided to a participant, beneficiary, or en-
rollee by a nonparticipating health care pro-
vider—
(i) the participant, beneficiary, or en-
rollee is not liable for amounts that exceed
the amounts of liability that would be in-
curred if the services were provided by a
participating health care provider, and
(ii) the plan or issuer pays an amount
that is not less than the amount paid to a
participating health care provider for the
same services; and
(D) without regard to any other term or
condition of such coverage (other than exclusion
or coordination of benefits, or an affiliation or
waiting period, permitted under section 2701 of
the Public Health Service Act, section 701 of
the Employee Retirement Income Security Act
of 1974, or section 9801 of the Internal Reve-
nue Code of 1986, and other than applicable
cost-sharing).
(2) DEFINITIONS.—In this section:
(A) EMERGENCY
MEDICAL
CONDITION
BASED ON PRUDENT LAYPERSON STANDARD.—
The term ‘‘emergency medical condition’’ means
a medical condition manifesting itself by acute
symptoms of sufficient severity (including se-
vere pain) such that a prudent layperson, who
possesses an average knowledge of health and
medicine, could reasonably expect the absence
of immediate medical attention to result in a
condition described in clause (i), (ii), or (iii) of
section 1867(e)(1)(A) of the Social Security
Act.
(B) EMERGENCY
SERVICES.—The term
‘‘emergency services’’ means—
(i) a medical screening examination
(as required under section 1867 of the So-
cial Security Act) that is within the capa-
bility of the emergency department of a
hospital, including ancillary services rou-
tinely available to the emergency depart-
ment to evaluate an emergency medical
condition (as defined in subparagraph
(A)), and
(ii) within the capabilities of the staff
and facilities available at the hospital, such
further medical examination and treatment
as are required under section 1867 of such
Act to stabilize the patient.
(b) REIMBURSEMENT FOR MAINTENANCE CARE AND
POST-STABILIZATION CARE.—In the case of services
(other than emergency services) for which benefits are
available under a group health plan, or under health insur-
ance coverage offered by a health insurance issuer, the
plan or issuer shall provide for reimbursement with re-
spect to such services provided to a participant, bene-
ficiary, or enrollee other than through a participating
health care provider in a manner consistent with sub-
section (a)(1)(C) if the services are maintenance care or
post-stabilization care covered under the guidelines estab-
lished under section 1852(d)(2) of the Social Security Act
(relating to promoting efficient and timely coordination of
appropriate maintenance and post-stabilization care of an
enrollee after an enrollee has been determined to be sta-
ble), or, in the absence of guidelines under such section,
such guidelines as the Secretary shall establish to carry
out this subsection.
SEC. 102. OFFERING OF CHOICE OF COVERAGE OPTIONS
UNDER GROUP HEALTH PLANS.
(a) REQUIREMENT.—
(1) OFFERING
OF
POINT-OF-SERVICE
COV-
ERAGE OPTION.—Except as provided in paragraph
(2), if a group health plan (or health insurance cov-
erage offered by a health insurance issuer in connec-
tion with a group health plan) provides benefits only
through participating health care providers, the plan
or issuer shall offer the participant the option to
purchase point-of-service coverage (as defined in
subsection (b)) for all such benefits for which cov-
erage is otherwise so limited. Such option shall be
made available to the participant at the time of en-
rollment under the plan or coverage and at such
other times as the plan or issuer offers the partici-
pant a choice of coverage options.
(2) EXCEPTION.—Paragraph (1) shall not
apply with respect to a participant in a group health
plan if the plan offers the participant—
(A) a choice of health insurance coverage
through more than one health insurance issuer;
or
(B) two or more coverage options that dif-
fer significantly with respect to the use of par-
ticipating health care providers or the networks
of such providers that are used.
(b) POINT-OF-SERVICE COVERAGE DEFINED.—In
this section, the term ‘‘point-of-service coverage’’ means,
with respect to benefits covered under a group health plan
or health insurance issuer, coverage of such benefits when
provided by a nonparticipating health care provider. Such
coverage need not include coverage of providers that the
plan or issuer excludes because of fraud, quality, or similar
reasons.
(c) CONSTRUCTION.—Nothing in this section shall be
construed—
(1) as requiring coverage for benefits for a par-
ticular type of health care provider;
(2) as requiring an employer to pay any costs
as a result of this section or to make equal contribu-
tions with respect to different health coverage op-
tions; or
(3) as preventing a group health plan or health
insurance issuer from imposing higher premiums or
cost-sharing on a participant for the exercise of a
point-of-service coverage option.
(d) NO REQUIREMENT
FOR GUARANTEED AVAIL-
ABILITY.—If a health insurance issuer offers health insur-
ance coverage that includes point-of-service coverage with
respect to an employer solely in order to meet the require-
ment of subsection (a), nothing in section 2711(a)(1)(A)
of the Public Health Service Act shall be construed as re-
quiring the offering of such coverage with respect to an-
other employer.
SEC. 103. CHOICE OF PROVIDERS.
(a) PRIMARY CARE.—A group health plan, and a
health insurance issuer that offers health insurance cov-
erage, shall permit each participant, beneficiary, and en-
rollee to receive primary care from any participating pri-
mary care provider who is available to accept such individ-
ual.
(b) SPECIALISTS.—
(1) IN GENERAL.—Subject to paragraph (2), a
group health plan and a health insurance issuer that
offers health insurance coverage shall permit each
participant, beneficiary, or enrollee to receive medi-
cally necessary or appropriate specialty care, pursu-
ant to appropriate referral procedures, from any
qualified participating health care provider who is
available to accept such individual for such care.
(2) LIMITATION.—Paragraph (1) shall not
apply to specialty care if the plan or issuer clearly
informs participants, beneficiaries, and enrollees of
the limitations on choice of participating providers
with respect to such care.
SEC. 104. ACCESS TO SPECIALTY CARE.
(a) OBSTETRICAL AND GYNECOLOGICAL CARE.—
(1) IN GENERAL.—If a group health plan, or a
health insurance issuer in connection with the provi-
sion of health insurance coverage, requires or pro-
vides for a participant, beneficiary, or enrollee to
designate a participating primary care provider—
(A) the plan or issuer shall permit such an
individual who is a female to designate a par-
ticipating physician who specializes in obstetrics
and gynecology as the individual’s primary care
provider; and
(B) if such an individual has not des-
ignated such a provider as a primary care pro-
vider, the plan or issuer—
(i) may not require authorization or a
referral by the individual’s primary care
provider or otherwise for coverage of rou-
tine gynecological care (such as preventive
women’s health examinations) and preg-
nancy-related services provided by a par-
ticipating health care professional who spe-
cializes in obstetrics and gynecology to the
extent such care is otherwise covered, and
(ii) may treat the ordering of other
gynecological care by such a participating
physician as the authorization of the pri-
mary care provider with respect to such
care under the plan or coverage.
(2) CONSTRUCTION.—Nothing in paragraph
(1)(B)(ii) shall waive any requirements of coverage
relating to medical necessity or appropriateness with
respect to coverage of gynecological care so ordered.
(b) SPECIALTY CARE.—
(1) SPECIALTY
CARE
FOR
COVERED
SERV-
ICES.—
(A) IN GENERAL.—If—
(i) an individual is a participant or
beneficiary under a group health plan or
an enrollee who is covered under health in-
surance coverage offered by a health insur-
ance issuer,
(ii) the individual has a condition or
disease of sufficient seriousness and com-
plexity to require treatment by a specialist,
and
(iii) benefits for such treatment are
provided under the plan or coverage,
the plan or issuer shall make or provide for a
referral to a specialist who is available and ac-
cessible to provide the treatment for such condi-
tion or disease.
(B) SPECIALIST DEFINED.—For purposes
of this subsection, the term ‘‘specialist’’ means,
with respect to a condition, a health care practi-
tioner, facility, or center (such as a center of
excellence) that has adequate expertise through
appropriate training and experience (including,
in the case of a child, appropriate pediatric ex-
pertise) to provide high quality care in treating
the condition.
(C) CARE
UNDER
REFERRAL.—A group
health plan or health insurance issuer may re-
quire that the care provided to an individual
pursuant to such referral under subparagraph
(A) be—
(i) pursuant to a treatment plan, only
if the treatment plan is developed by the
specialist and approved by the plan or
issuer, in consultation with the designated
primary care provider or specialist and the
individual (or the individual’s designee),
and
(ii) in accordance with applicable
quality assurance and utilization review
standards of the plan or issuer.
Nothing in this subsection shall be construed as
preventing such a treatment plan for an individ-
ual from requiring a specialist to provide the
primary care provider with regular updates on
the specialty care provided, as well as all nec-
essary medical information.
(D) REFERRALS TO PARTICIPATING PRO-
VIDERS.—A group health plan or health insur-
ance issuer is not required under subparagraph
(A) to provide for a referral to a specialist that
is not a participating provider, unless the plan
or issuer does not have an appropriate specialist
that is available and accessible to treat the indi-
vidual’s condition and that is a participating
provider with respect to such treatment.
(E) TREATMENT
OF
NONPARTICIPATING
PROVIDERS.—If a plan or issuer refers an indi-
vidual to a nonparticipating specialist pursuant
to subparagraph (A), services provided pursu-
ant to the approved treatment plan (if any)
shall be provided at no additional cost to the in-
dividual beyond what the individual would oth-
erwise pay for services received by such a spe-
cialist that is a participating provider.
(2) SPECIALISTS
AS
PRIMARY
CARE
PROVID-
ERS.—
(A) IN GENERAL.—A group health plan, or
a health insurance issuer, in connection with
the provision of health insurance coverage, shall
have a procedure by which an individual who is
a participant, beneficiary, or enrollee and who
has an ongoing special condition (as defined in
subparagraph (C)) may receive a referral to a
specialist for such condition who shall be re-
sponsible for and capable of providing and co-
ordinating the individual’s primary and spe-
cialty care. If such an individual’s care would
most appropriately be coordinated by such a
specialist, such plan or issuer shall refer the in-
dividual to such specialist.
(B) TREATMENT AS PRIMARY CARE PRO-
VIDER.—Such specialist shall be permitted to
treat the individual without a referral from the
individual’s primary care provider and may au-
thorize such referrals, procedures, tests, and
other medical services as the individual’s pri-
mary care provider would otherwise be per-
mitted to provide or authorize, subject to the
terms of the treatment plan (referred to in
paragraph (1)(C)(i)).
(C) ONGOING
SPECIAL
CONDITION
DE-
FINED.—In this paragraph, the term ‘‘special
condition’’ means a condition or disease that—
(i) is life-threatening, degenerative, or
disabling, and
(ii) requires specialized medical care
over a prolonged period of time.
(D) TERMS
OF
REFERRAL.—The provi-
sions of subparagraphs (C) through (E) of
paragraph (1) apply with respect to referrals
under subparagraph (A) of this paragraph in
the same manner as they apply to referrals
under paragraph (1)(A).
(3) STANDING REFERRALS.—
(A) IN GENERAL.—A group health plan,
and a health insurance issuer in connection
with the provision of health insurance coverage,
shall have a procedure by which an individual
who is a participant, beneficiary, or enrollee
and who has a condition that requires ongoing
care from a specialist may receive a standing
referral to such specialist for treatment of such
condition. If the plan or issuer, or if the pri-
mary care provider in consultation with the
medical director of the plan or issuer and the
specialist (if any), determines that such a
standing referral is appropriate, the plan or
issuer shall make such a referral to such a spe-
cialist.
(B) TERMS
OF
REFERRAL.—The provi-
sions of subparagraphs (C) through (E) of
paragraph (1) apply with respect to referrals
under subparagraph (A) of this paragraph in
the same manner as they apply to referrals
under paragraph (1)(A).
SEC. 105. CONTINUITY OF CARE.
(a) IN GENERAL.—
(1) TERMINATION OF PROVIDER.—If a contract
between a group health plan, or a health insurance
issuer in connection with the provision of health in-
surance coverage, and a health care provider is ter-
minated (as defined in paragraph (3)), or benefits or
coverage provided by a health care provider are ter-
minated because of a change in the terms of pro-
vider participation in a group health plan, and an in-
dividual who is a participant, beneficiary, or enrollee
in the plan or coverage is undergoing a course of
treatment from the provider at the time of such ter-
mination, the plan or issuer shall—
(A) notify the individual on a timely basis
of such termination, and
(B) subject to subsection (c), permit the
individual to continue or be covered with re-
spect to the course of treatment with the pro-
vider during a transitional period (provided
under subsection (b)).
(2) TREATMENT
OF
TERMINATION
OF
CON-
TRACT
WITH
HEALTH
INSURANCE
ISSUER.—If a
contract for the provision of health insurance cov-
erage between a group health plan and a health in-
surance issuer is terminated and, as a result of such
termination, coverage of services of a health care
provider is terminated with respect to an individual,
the provisions of paragraph (1) (and the succeeding
provisions of this section) shall apply under the plan
in the same manner as if there had been a contract
between the plan and the provider that had been ter-
minated, but only with respect to benefits that are
covered under the plan after the contract termi-
nation.
(3) TERMINATION.—In this section, the term
‘‘terminated’’ includes, with respect to a contract,
the expiration 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.
(b) TRANSITIONAL PERIOD.—
(1) IN GENERAL.—Except as provided in para-
graphs (2) through (4), the transitional period under
this subsection shall extend for at least 90 days from
the date of the notice described in subsection
(a)(1)(A) of the provider’s termination.
(2) INSTITUTIONAL CARE.—The transitional pe-
riod under this subsection for institutional or inpa-
tient care from a provider shall extend until the dis-
charge or termination of the period of institutional-
ization and also shall include institutional care pro-
vided within a reasonable time of the date of termi-
nation of the provider status if the care was sched-
uled before the date of the announcement of the ter-
mination of the provider status under subsection
(a)(1)(A) or if the individual on such date was on
an established waiting list or otherwise scheduled to
have such care.
(3) PREGNANCY.—If—
(A) a participant, beneficiary, or enrollee
has entered the second trimester of pregnancy
at the time of a provider’s termination of par-
ticipation, and
(B) the provider was treating the preg-
nancy before date of the termination,
the transitional period under this subsection with re-
spect to provider’s treatment of the pregnancy shall
extend through the provision of post-partum care di-
rectly related to the delivery.
(4) TERMINAL ILLNESS.—If—
(A) a participant, beneficiary, or enrollee
was determined to be terminally ill (as deter-
mined under section 1861(dd)(3)(A) of the So-
cial Security Act) at the time of a provider’s
termination of participation, and
(B) the provider was treating the terminal
illness before the date of termination,
the transitional period under this subsection shall
extend for the remainder of the individual’s life for
care directly related to the treatment of the terminal
illness.
(c) PERMISSIBLE
TERMS
AND
CONDITIONS.—A
group health plan or health insurance issuer may condi-
tion coverage of continued treatment by a provider under
subsection (a)(1)(B) upon the provider agreeing to the fol-
lowing terms and conditions:
(1) The provider agrees to accept reimburse-
ment from the plan or issuer and individual involved
(with respect to cost-sharing) at the rates applicable
prior to the start of the transitional period as pay-
ment in full (or, in the case described in subsection
(a)(2), 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 impose cost-sharing with respect to the indi-
vidual in an amount that would exceed the cost-shar-
ing that could have been imposed if the contract re-
ferred to in subsection (a)(1) had not been termi-
nated.
(2) The provider agrees to adhere to the quality
assurance standards of the plan or issuer responsible
for payment under paragraph (1) and to provide to
such plan or issuer necessary medical information
related to the care provided.
(3) The provider agrees otherwise to adhere to
such plan’s or issuer’s policies and procedures, in-
cluding procedures regarding referrals and obtaining
prior authorization and providing services pursuant
to a treatment plan (if any) approved by the plan or
issuer.
(d) CONSTRUCTION.—Nothing in this section shall be
construed to require the coverage of benefits which would
not have been covered if the provider involved remained
a participating provider.
SEC. 106. COVERAGE FOR INDIVIDUALS PARTICIPATING IN
APPROVED CLINICAL TRIALS.
(a) COVERAGE.—
(1) IN GENERAL.—If a group health plan, or
health insurance issuer that is providing health in-
surance coverage, provides coverage to a qualified in-
dividual (as defined in subsection (b)), the plan or
issuer—
(A) may not deny the individual participa-
tion in the clinical trial referred to in subsection
(b)(2);
(B) subject to subsection (c), may not deny
(or limit or impose additional conditions on) the
coverage of routine patient costs for items and
services furnished in connection with participa-
tion in the trial; and
(C) may not discriminate against the indi-
vidual on the basis of the enrollee’s participa-
tion in such trial.
(2) EXCLUSION OF CERTAIN COSTS.—For pur-
poses of paragraph (1)(B), routine patient costs do
not include the cost of the tests or measurements
conducted primarily for the purpose of the clinical
trial involved.
(3) USE OF IN-NETWORK PROVIDERS.—If one
or more participating providers is participating in a
clinical trial, nothing in paragraph (1) shall be con-
strued as preventing a plan or issuer from requiring
that a qualified individual participate in the trial
through such a participating provider if the provider
will accept the individual as a participant in the
trial.
(b) QUALIFIED INDIVIDUAL DEFINED.—For pur-
poses of subsection (a), the term ‘‘qualified individual’’
means an individual who is a participant or beneficiary
in a group health plan, or who is an enrollee under health
insurance coverage, and who meets the following condi-
tions:
(1)(A) The individual has a life-threatening or
serious illness for which no standard treatment is ef-
fective.
(B) The individual is eligible to participate in
an approved clinical trial according to the trial pro-
tocol with respect to treatment of such illness.
(C) The individual’s participation in the trial
offers meaningful potential for significant clinical
benefit for the individual.
(2) Either—
(A) the referring physician is a participat-
ing health care professional and has concluded
that the individual’s participation in such trial
would be appropriate based upon the individual
meeting the conditions described in paragraph
(1); or
(B) the participant, beneficiary, or enrollee
provides medical and scientific information es-
tablishing that the individual’s participation in
such trial would be appropriate based upon the
individual meeting the conditions described in
paragraph (1).
(c) PAYMENT.—
(1) IN GENERAL.—Under this section a group
health plan or health insurance issuer shall provide
for payment for routine patient costs described in
subsection (a)(2) but is not required to pay for costs
of items and services that are reasonably expected
(as determined by the Secretary) to be paid for by
the sponsors of an approved clinical trial.
(2) PAYMENT RATE.—In the case of covered
items and services provided by—
(A) a participating provider, the payment
rate shall be at the agreed upon rate, or
(B) a nonparticipating provider, the pay-
ment rate shall be at the rate the plan or issuer
would normally pay for comparable services
under subparagraph (A).
(d) APPROVED CLINICAL TRIAL DEFINED.—
(1) IN
GENERAL.—In this section, the term
‘‘approved clinical trial’’ means a clinical research
study or clinical investigation approved and funded
(which may include funding through in-kind con-
tributions) by one or more of the following:
(A) The National Institutes of Health.
(B) A cooperative group or center of the
National Institutes of Health.
(C) Either of the following if the condi-
tions described in paragraph (2) are met:
(i) The Department of Veterans Af-
fairs.
(ii) The Department of Defense.
(2) CONDITIONS
FOR
DEPARTMENTS.—The
conditions described in this paragraph, for a study
or investigation conducted by a Department, are
that the study or investigation has been reviewed
and approved through a system of peer review that
the Secretary determines—
(A) to be comparable to the system of peer
review of studies and investigations used by the
National Institutes of Health, and
(B) assures unbiased review of the highest
scientific standards by qualified individuals who
have no interest in the outcome of the review.
(e) CONSTRUCTION.—Nothing in this section shall be
construed to limit a plan’s or issuer’s coverage with re-
spect to clinical trials.
SEC. 107. ACCESS TO NEEDED PRESCRIPTION DRUGS.
(a) IN GENERAL.—If a group health plan, or health
insurance issuer that offers health insurance coverage,
provides benefits with respect to prescription drugs but
the coverage limits such benefits to drugs included in a
formulary, the plan or issuer shall—
(1) ensure participation of participating physi-
cians and pharmacists in the development of the for-
mulary;
(2) disclose to providers and, disclose upon re-
quest under section 121(c)(6) to participants, bene-
ficiaries, and enrollees, the nature of the formulary
restrictions; and
(3) consistent with the standards for a utiliza-
tion review program under section 115, provide for
exceptions from the formulary limitation when a
non-formulary alternative is medically indicated.
(b) COVERAGE OF APPROVED DRUGS AND MEDICAL
DEVICES.—
(1) IN
GENERAL.—A group health plan (or
health insurance coverage offered in connection with
such a plan) that provides any coverage of prescrip-
tion drugs or medical devices shall not deny coverage
of such a drug or device on the basis that the use
is investigational, if the use—
(A) in the case of a prescription drug—
(i) is included in the labeling author-
ized by the application in effect for the
drug pursuant to subsection (b) or (j) of
section 505 of the Federal Food, Drug,
and Cosmetic Act, without regard to any
postmarketing 
requirements 
that 
may
apply under such Act; or
(ii) is included in the labeling author-
ized by the application in effect for the
drug under section 351 of the Public
Health Service Act, without regard to any
postmarketing 
requirements 
that 
may
apply pursuant to such section; or
(B) in the case of a medical device, is in-
cluded in the labeling authorized by a regula-
tion under subsection (d) or (3) of section 513
of the Federal Food, Drug, and Cosmetic Act,
an order under subsection (f) of such section, or
an application approved under section 515 of
such Act, without regard to any postmarketing
requirements that may apply under such Act.
(2) CONSTRUCTION.—Nothing in this sub-
section shall be construed as requiring a group
health plan (or health insurance coverage offered in
connection with such a plan) to provide any coverage
of prescription drugs or medical devices.
SEC. 108. ADEQUACY OF PROVIDER NETWORK.
(a) IN GENERAL.—Each group health plan, and each
health insurance issuer offering health insurance coverage,
that provides benefits, in whole or in part, through partici-
pating health care providers shall have (in relation to the
coverage) a sufficient number, distribution, and variety of
qualified participating health care providers to ensure that
all covered health care services, including specialty serv-
ices, will be available and accessible in a timely manner
to all participants, beneficiaries, and enrollees under the
plan or coverage.
(b) TREATMENT
OF
CERTAIN
PROVIDERS.—The
qualified health care providers under subsection (a) may
include Federally qualified health centers, rural health
clinics, migrant health centers, and other essential com-
munity providers located in the service area of the plan
or issuer and shall include such providers if necessary to
meet the standards established to carry out such sub-
section.
SEC. 109. NONDISCRIMINATION IN DELIVERY OF SERVICES.
(a) APPLICATION TO DELIVERY OF SERVICES.—Sub-
ject to subsection (b), a group health plan, and health in-
surance issuer in relation to health insurance coverage,
may not discriminate against a participant, beneficiary, or
enrollee in the delivery of health care services consistent
with the benefits covered under the plan or coverage or
as required by law based on race, color, ethnicity, national
origin, religion, sex, age, mental or physical disability, sex-
ual orientation, genetic information, or source of payment.
(b) CONSTRUCTION.—Nothing in subsection (a) shall
be construed as relating to the eligibility to be covered,
or the offering (or guaranteeing the offer) of coverage,
under a plan or health insurance coverage, the application
of any pre-existing condition exclusion consistent with ap-
plicable law, or premiums charged under such plan or cov-
erage.
Subtitle B—Quality Assurance
SEC. 111. INTERNAL QUALITY ASSURANCE PROGRAM.
(a) REQUIREMENT.—A group health plan, and a
health insurance issuer that offers health insurance cov-
erage, shall establish and maintain an ongoing, internal
quality assurance and continuous quality improvement
program that meets the requirements of subsection (b).
(b) PROGRAM REQUIREMENTS.—The requirements of
this subsection for a quality improvement program of a
plan or issuer are as follows:
(1) ADMINISTRATION.—The plan or issuer has
a separate identifiable unit with responsibility for
administration of the program.
(2) WRITTEN PLAN.—The plan or issuer has a
written plan for the program that is updated annu-
ally and that specifies at least the following:
(A) The activities to be conducted.
(B) The organizational structure.
(C) The duties of the medical director.
(D) Criteria and procedures for the assess-
ment of quality.
(3) SYSTEMATIC REVIEW.—The program pro-
vides for systematic review of the type of health
services provided, consistency of services provided
with good medical practice, and patient outcomes.
(4) QUALITY CRITERIA.—The program—
(A) uses criteria that are based on per-
formance and patient outcomes where feasible
and appropriate;
(B) includes criteria that are directed spe-
cifically at meeting the needs of at-risk popu-
lations and covered individuals with chronic
conditions or severe illnesses, including gender-
specific criteria and pediatric-specific criteria
where available and appropriate;
(C) includes methods for informing covered
individuals of the benefit of preventive care and
what specific benefits with respect to preventive
care are covered under the plan or coverage;
and
(D) makes available to the public a de-
scription of the criteria used under subpara-
graph (A).
(5) SYSTEM
FOR
REPORTING.—The program
has procedures for reporting of possible quality con-
cerns by providers and enrollees and for remedial ac-
tions to correct quality problems, including written
procedures for responding to concerns and taking
appropriate corrective action.
(6) DATA
ANALYSIS.—The program provides,
using data that include the data collected under sec-
tion 112, for an analysis of the plan’s or issuer’s
performance on quality measures.
(7) DRUG UTILIZATION REVIEW.—The program
provides for a drug utilization review program in ac-
cordance with section 114.
(c) DEEMING.—For purposes of subsection (a), the
requirements of—
(1) subsection (b) (other than paragraph (5))
are deemed to be met with respect to a health insur-
ance issuer that is a qualified health maintenance
organization (as defined in section 1310(c) of the
Public Health Service Act); or
(2) subsection (b) are deemed to be met with
respect to a health insurance issuer that is accred-
ited by a national accreditation organization that the
Secretary certifies as applying, as a condition of cer-
tification, standards at least a stringent as those re-
quired for a quality improvement program under
subsection (b).
(d) VARIATION PERMITTED.—The Secretary may
provide for variations in the application of the require-
ments of this section to group health plans and health in-
surance issuers based upon differences in the delivery sys-
tem among such plans and issuers as the Secretary deems
appropriate.
SEC. 112. COLLECTION OF STANDARDIZED DATA.
(a) IN GENERAL.—A group health plan and a health
insurance issuer that offers health insurance coverage
shall collect uniform quality data that include a minimum
uniform data set described in subsection (b).
(b) MINIMUM UNIFORM DATA SET.—The Secretary
shall specify (and may from time to time update) the data
required to be included in the minimum uniform data set
under subsection (a) and the standard format for such
data. Such data shall include at least—
(1) aggregate utilization data;
(2) data on the demographic characteristics of
participants, beneficiaries, and enrollees;
(3) data on disease-specific and age-specific
mortality rates and (to the extent feasible) morbidity
rates of such individuals;
(4) data on satisfaction of such individuals, in-
cluding data on voluntary disenrollment and griev-
ances; and
(5) data on quality indicators and health out-
comes, including, to the extent feasible and appro-
priate, data on pediatric cases and on a gender-spe-
cific basis.
(c) AVAILABILITY.—A summary of the data collected
under subsection (a) shall be disclosed under section
121(b)(9). The Secretary shall be provided access to all
the data so collected.
(d) VARIATION PERMITTED.—The Secretary may
provide for variations in the application of the require-
ments of this section to group health plans and health in-
surance issuers based upon differences in the delivery sys-
tem among such plans and issuers as the Secretary deems
appropriate.
SEC. 113. PROCESS FOR SELECTION OF PROVIDERS.
(a) IN GENERAL.—A group health plan and a health
insurance issuer that offers health insurance coverage
shall, if it provides benefits through participating health
care professionals, have a written process for the selection
of participating health care professionals, including mini-
mum professional requirements.
(b) VERIFICATION OF BACKGROUND.—Such process
shall include verification of a health care provider’s license
and a history of suspension or revocation.
(c) RESTRICTION.—Such process shall not use a
high-risk patient base or location of a provider in an area
with residents with poorer health status as a basis for ex-
cluding providers from participation.
(d) NONDISCRIMINATION BASED ON LICENSURE.—
(1) IN GENERAL.—Such process shall not dis-
criminate with respect to participation or indem-
nification as to any provider who is acting within the
scope of the provider’s license or certification under
applicable State law, solely on the basis of such li-
cense or certification.
(2) CONSTRUCTION.—Paragraph (1) shall not
be construed—
(A) as requiring the coverage under a plan
or coverage of particular benefits or services or
to prohibit a plan or issuer from including pro-
viders only to the extent necessary to meet the
needs of the plan’s or issuer’s participants,
beneficiaries, or enrollees or from establishing
any measure designed to maintain quality and
control costs consistent with the responsibilities
of the plan or issuer; or
(B) to override any State licensure or
scope-of-practice law.
(e) GENERAL NONDISCRIMINATION.—
(1) IN GENERAL.—Subject to paragraph (2),
such process shall not discriminate with respect to
selection of a health care professional to be a partici-
pating health care provider, or with respect to the
terms and conditions of such participation, based on
the professional’s race, color, religion, sex, national
origin, age, sexual orientation, or disability (consist-
ent with the Americans with Disabilities Act of
1990).
(2) RULES.—The appropriate Secretary may
establish such definitions, rules, and exceptions as
may be appropriate to carry out paragraph (1), tak-
ing into account comparable definitions, rules, and
exceptions in effect under employment-based non-
discrimination laws and regulations that relate to
each of the particular bases for discrimination de-
scribed in such paragraph.
SEC. 114. DRUG UTILIZATION PROGRAM.
A group health plan, and a health insurance issuer
that provides health insurance coverage, that includes ben-
efits for prescription drugs shall establish and maintain,
as part of its internal quality assurance and continuous
quality improvement program under section 111, a drug
utilization program which—
(1) encourages appropriate use of prescription
drugs by participants, beneficiaries, and enrollees
and providers, and
(2) takes appropriate action to reduce the inci-
dence of improper drug use and adverse drug reac-
tions and interactions.
SEC. 115. STANDARDS FOR UTILIZATION REVIEW ACTIVI-
TIES.
(a) COMPLIANCE WITH REQUIREMENTS.—
(1) IN GENERAL.—A group health plan, and a
health insurance issuer that provides health insur-
ance coverage, shall conduct utilization review activi-
ties in connection with the provision of benefits
under such plan or coverage only in accordance with
a utilization review program that meets the require-
ments of this section.
(2) USE OF OUTSIDE AGENTS.—Nothing in this
section shall be construed as preventing a group
health plan or health insurance issuer from arrang-
ing through a contract or otherwise for persons or
entities to conduct utilization review activities on be-
half of the plan or issuer, so long as such activities
are conducted in accordance with a utilization review
program that meets the requirements of this section.
(3) UTILIZATION REVIEW DEFINED.—For pur-
poses of this section, the terms ‘‘utilization review’’
and ‘‘utilization review activities’’ mean procedures
used to monitor or evaluate the clinical necessity,
appropriateness, efficacy, or efficiency of health care
services, procedures or settings, and includes pro-
spective review, concurrent review, second opinions,
case management, discharge planning, or retrospec-
tive review.
(b) WRITTEN POLICIES AND CRITERIA.—
(1) WRITTEN POLICIES.—A utilization review
program shall be conducted consistent with written
policies and procedures that govern all aspects of the
program.
(2) USE OF WRITTEN CRITERIA.—
(A) IN GENERAL.—Such a program shall
utilize written clinical review criteria developed
pursuant to the program with the input of ap-
propriate physicians. Such criteria shall include
written clinical review criteria described in sec-
tion 111(b)(4)(B).
(B) CONTINUING USE OF STANDARDS IN
RETROSPECTIVE
REVIEW.—If a health care
service has been specifically pre-authorized or
approved for an enrollee under such a program,
the program shall not, pursuant to retrospective
review, revise or modify the specific standards,
criteria, or procedures used for the utilization
review for procedures, treatment, and services
delivered to the enrollee during the same course
of treatment.
(c) CONDUCT OF PROGRAM ACTIVITIES.—
(1) ADMINISTRATION BY HEALTH CARE PRO-
FESSIONALS.—A utilization review program shall be
administered by qualified health care professionals
who shall oversee review decisions. In this sub-
section, the term ‘‘health care professional’’ means a
physician or other health care practitioner licensed,
accredited, or certified to perform specified health
services consistent with State law.
(2) USE
OF
QUALIFIED, INDEPENDENT
PER-
SONNEL.—
(A) IN
GENERAL.—A utilization review
program shall provide for the conduct of utiliza-
tion review activities only through personnel
who are qualified and, to the extent required,
who have received appropriate training in the
conduct of such activities under the program.
(B) PEER
REVIEW
OF
SAMPLE
OF
AD-
VERSE
CLINICAL
DETERMINATIONS.—Such a
program shall provide that clinical peers (as de-
fined in section 191(c)(2)) shall evaluate the
clinical appropriateness of at least a sample of
adverse clinical determinations.
(C) PROHIBITION
OF
CONTINGENT
COM-
PENSATION ARRANGEMENTS.—Such a program
shall not, with respect to utilization review ac-
tivities, permit or provide compensation or any-
thing of value to its employees, agents, or con-
tractors in a manner that—
(i) provides incentives, direct or indi-
rect, for such persons to make inappropri-
ate review decisions, or
(ii) is based, directly or indirectly, on
the quantity or type of adverse determina-
tions rendered.
(6) REVIEW OF PRELIMINARY UTILIZATION RE-
VIEW
DECISION.—Under such program a partici-
pant, beneficiary, or enrollee or any provider acting
on behalf of such an individual with the individual’s
consent, who is dissatisfied with a preliminary utili-
zation review decision has the opportunity to discuss
the decision with, and have such decision reviewed
by, the medical director of the plan or issuer in-
volved (or the director’s designee) who has the au-
thority to reverse the decision.
(d) DEADLINE FOR DETERMINATIONS.—
(1) PRIOR AUTHORIZATION SERVICES.—Except
as provided in paragraph (2), in the case of a utili-
zation review activity involving the prior authoriza-
tion of health care items and services for an individ-
ual, the utilization review program shall make a de-
termination concerning such authorization, and pro-
vide notice of the determination to the individual or
the individual’s designee and the individual’s health
care provider by telephone and in printed form, as
soon as possible in accordance with the medical ex-
igencies of the cases, and in no event later than 3
business days after the date of receipt of information
that is reasonably necessary to make such deter-
mination.
(2) CONTINUED CARE.—In the case of a utiliza-
tion review activity involving authorization for con-
tinued or extended health care services for an indi-
vidual, or additional services for an individual under-
going a course of continued treatment prescribed by
a health care provider, the utilization review pro-
gram shall make a determination concerning such
authorization, and provide notice of the determina-
tion to the individual or the individual’s designee
and the individual’s health care provider by tele-
phone and in printed form, as soon as possible in ac-
cordance with the medical exigencies of the cases,
and in no event later than 1 business day after the
date of receipt of information that is reasonably nec-
essary to make such determination. Such notice shall
include, with respect to continued or extended health
care services, the number of extended services ap-
proved, the new total of approved services, the date
of onset of services, and the next review date, if any.
(3) PREVIOUSLY PROVIDED SERVICES.—In the
case of a utilization review activity involving retro-
spective review of health care services previously pro-
vided for an individual, the utilization review pro-
gram shall make a determination concerning such
services, and provide notice of the determination to
the individual or the individual’s designee and the
individual’s health care provider by telephone and in
printed form, within 30 days of the date of receipt
of information that is reasonably necessary to make
such determination.
(4) REFERENCE TO SPECIAL RULES FOR EMER-
GENCY SERVICES, MAINTENANCE CARE, AND POST-
STABILIZATION CARE.—For waiver of prior author-
ization requirements in certain cases involving emer-
gency services and maintenance care and post-sta-
bilization care, see subsections (a)(1) and (b) of sec-
tion 101, respectively.
(e) NOTICE OF ADVERSE DETERMINATIONS.—
(1) IN GENERAL.—Notice of an adverse deter-
mination under a utilization review program shall be
provided in printed form and shall include—
(A) the reasons for the determination (in-
cluding the clinical rationale);
(B) instructions on how to initiate an ap-
peal under section 132; and
(C) notice of the availability, upon request
of the individual (or the individual’s designee)
of the clinical review criteria relied upon to
make such determination.
(2) SPECIFICATION OF ANY ADDITIONAL INFOR-
MATION.—Such a notice shall also specify what (if
any) additional necessary information must be pro-
vided to, or obtained by, the person making the de-
termination in order to make a decision on such an
appeal.
SEC. 116. HEALTH CARE QUALITY ADVISORY BOARD.
(a) ESTABLISHMENT.—The President shall establish
an advisory board to provide information to Congress and
the administration on issues relating to quality monitoring
and improvement in the health care provided under group
health plans and health insurance coverage.
(b) NUMBER
AND APPOINTMENT.—The advisory
board shall be composed of the Secretary of Health and
Human Services (or the Secretary’s designee), the Sec-
retary of Labor (or the Secretary’s designee), and 20 addi-
tional members appointed by the President, in consulta-
tion with the Majority and Minority Leaders of the Senate
and House of Representatives. The members so appointed
shall include individuals with expertise in—
(1) consumer needs;
(2) education and training of health profes-
sionals;
(3) health care services;
(4) health plan management;
(5) health care accreditation, quality assurance,
improvement, measurement, and oversight;
(6) medical practice, including practicing physi-
cians;
(7) prevention and public health; and
(8) public and private group purchasing for
small and large employers or groups.
(c) DUTIES.—The advisory board shall—
(1) identify, update, and disseminate measures
of health care quality for group health plans and
health insurance issuers, including network and non-
network plans;
(2) advise the Secretary on the development
and maintenance of the minimum data set in section
112(b); and
(3) advise the Secretary on standardized for-
mats for information on group health plans and
health insurance coverage.
The measures identified under paragraph (1) may be used
on a voluntary basis by such plans and issuers. In carrying
out paragraph (1), the advisory board shall consult and
cooperate with national health care standard setting bod-
ies which define quality indicators, the Agency for Health
Care Policy and Research, the Institute of Medicine, and
other public and private entities that have expertise in
health care quality.
(d) REPORT.—The advisory board shall provide an
annual report to Congress and the President on the qual-
ity of the health care in the United States and national
and regional trends in health care quality. Such report
shall include a description of determinants of health care
quality and measurements of practice and quality varia-
bility within the United States.
(e) SECRETARIAL CONSULTATION.—In serving on
the advisory board, the Secretaries of Health and Human
Services and Labor (or their designees) shall consult with
the Secretaries responsible for other Federal health insur-
ance and health care programs.
(f) VACANCIES.—Any vacancy on the board shall be
filled in such manner as the original appointment. Mem-
bers of the board shall serve without compensation but
shall be reimbursed for travel, subsistence, and other nec-
essary expenses incurred by them in the performance of
their duties. Administrative support, scientific support,
and technical assistance for the advisory board shall be
provided by the Secretary of Health and Human Services.
(g) CONTINUATION.—Section 14(a)(2)(B) of the
Federal Advisory Committee Act (5 U.S.C. App.; relating
to the termination of advisory committees) shall not apply
to the advisory board.
Subtitle C—Patient Information
SEC. 121. PATIENT INFORMATION.
(a) DISCLOSURE REQUIREMENT.—
(1) GROUP HEALTH PLANS.—A group health
plan shall—
(A) provide to participants and bene-
ficiaries at the time of initial coverage under
the plan (or the effective date of this section, in
the case of individuals who are participants or
beneficiaries as of such date), and at least an-
nually thereafter, the information described in
subsection (b) in printed form;
(B) provide to participants and bene-
ficiaries, within a reasonable period (as speci-
fied by the appropriate Secretary) before or
after the date of significant changes in the in-
formation described in subsection (b), informa-
tion in printed form on such significant
changes; and
(C) upon request, make available to par-
ticipants and beneficiaries, the applicable au-
thority, and prospective participants and bene-
ficiaries, the information described in sub-
section (b) or (c) in printed form.
(2) HEALTH
INSURANCE
ISSUERS.—A health
insurance issuer in connection with the provision of
health insurance coverage shall—
(A) provide to individuals enrolled under
such coverage at the time of enrollment, and at
least annually thereafter, the information de-
scribed in subsection (b) in printed form;
(B) provide to enrollees, within a reason-
able period (as specified by the appropriate Sec-
retary) before or after the date of significant
changes in the information described in sub-
section (b), information in printed form on such
significant changes; and
(C) upon request, make available to the
applicable authority, to individuals who are pro-
spective enrollees, and to the public the infor-
mation described in subsection (b) or (c) in
printed form.
(b) INFORMATION PROVIDED.—The information de-
scribed in this subsection with respect to a group health
plan or health insurance coverage offered by a health in-
surance issuer includes the following:
(1) SERVICE AREA.—The service area of the
plan or issuer.
(2) BENEFITS.—Benefits offered under the
plan or coverage, including—
(A) covered benefits, including benefit lim-
its and coverage exclusions;
(B) cost sharing, such as deductibles, coin-
surance, and copayment amounts, including any
liability for balance billing, any maximum limi-
tations on out of pocket expenses, and the max-
imum out of pocket costs for services that are
provided by non participating providers or that
are furnished without meeting the applicable
utilization review requirements;
(C) the extent to which benefits may be ob-
tained from nonparticipating providers;
(D) the extent to which a participant, ben-
eficiary, or enrollee may select from among par-
ticipating providers and the types of providers
participating in the plan or issuer network;
(E) process for determining experimental
coverage; and
(F) use of a prescription drug formulary.
(3) ACCESS.—A description of the following:
(A) The number, mix, and distribution of
providers under the plan or coverage.
(B) Out-of-network coverage (if any) pro-
vided by the plan or coverage.
(C) Any point-of-service option (including
any supplemental premium or cost-sharing for
such option).
(D) The procedures for participants, bene-
ficiaries, and enrollees to select, access, and
change participating primary and specialty pro-
viders.
(E) The rights and procedures for obtain-
ing referrals (including standing referrals) to
participating and nonparticipating providers.
(F) The name, address, and telephone
number of participating health care providers
and an indication of whether each such provider
is available to accept new patients.
(G) Any limitations imposed on the selec-
tion of qualifying participating health care pro-
viders, including any limitations imposed under
section 103(b)(2).
(H) How the plan or issuer addresses the
needs of participants, beneficiaries, and enroll-
ees and others who do not speak English or
who have other special communications needs in
accessing providers under the plan or coverage,
including the provision of information described
in this subsection and subsection (c) to such in-
dividuals and including the provision of infor-
mation in a language other than English if 5
percent of the number of participants, bene-
ficiaries, and enrollees communicate in that lan-
guage instead of English.
(4) OUT-OF-AREA COVERAGE.—Out-of-area cov-
erage provided by the plan or issuer.
(5) 
EMERGENCY
COVERAGE.—Coverage 
of
emergency services, including—
(A) the appropriate use of emergency serv-
ices, including use of the 911 telephone system
or its local equivalent in emergency situations
and an explanation of what constitutes an
emergency situation;
(B) the process and procedures of the plan
or issuer for obtaining emergency services; and
(C) the locations of (i) emergency depart-
ments, and (ii) other settings, in which plan
physicians and hospitals provide emergency
services and post-stabilization care.
(6) PERCENTAGE
OF
PREMIUMS
USED
FOR
BENEFITS (LOSS-RATIOS).—In the case of health in-
surance coverage only (and not with respect to group
health plans that do not provide coverage through
health insurance coverage), a description of the over-
all loss-ratio for the coverage (as defined in accord-
ance with rules established or recognized by the Sec-
retary of Health and Human Services).
(7) PRIOR AUTHORIZATION RULES.—Rules re-
garding prior authorization or other review require-
ments that could result in noncoverage or non-
payment.
(8) GRIEVANCE AND APPEALS PROCEDURES.—
All appeal or grievance rights and procedures under
the plan or coverage, including the method for filing
grievances and the time frames and circumstances
for acting on grievances and appeals, who is the ap-
plicable authority with respect to the plan or issuer,
and the availability of assistance through an om-
budsman to individuals in relation to group health
plans and health insurance coverage.
(9) QUALITY ASSURANCE.—A summary descrip-
tion of the data on quality collected under section
112(a), including a summary description of the data
on satisfaction of participants, beneficiaries, and en-
rollees (including data on individual voluntary
disenrollment and grievances and appeals) described
in section 112(b)(4).
(10) SUMMARY
OF
PROVIDER
FINANCIAL
IN-
CENTIVES.—A summary description of the informa-
tion on the types of financial payment incentives
(described in section 1852(j)(4) of the Social Secu-
rity Act) provided by the plan or issuer under the
coverage.
(11) INFORMATION ON ISSUER.—Notice of ap-
propriate mailing addresses and telephone numbers
to be used by participants, beneficiaries, and enroll-
ees in seeking information or authorization for treat-
ment.
(12) AVAILABILITY OF INFORMATION ON RE-
QUEST.—Notice that the information described in
subsection (c) is available upon request.
(c) INFORMATION MADE AVAILABLE UPON RE-
QUEST.—The information described in this subsection is
the following:
(1) UTILIZATION REVIEW ACTIVITIES.—A de-
scription of procedures used and requirements (in-
cluding circumstances, time frames, and appeal
rights) under any utilization review program under
section 115, including under any drug formulary
program under section 107.
(2) GRIEVANCE AND APPEALS INFORMATION.—
Information on the number of grievances and ap-
peals and on the disposition in the aggregate of such
matters.
(3) METHOD OF PHYSICIAN COMPENSATION.—
An overall summary description as to the method of
compensation of participating physicians, including
information on the types of financial payment incen-
tives (described in section 1852(j)(4) of the Social
Security Act) provided by the plan or issuer under
the coverage.
(4) SPECIFIC INFORMATION ON CREDENTIALS
OF PARTICIPATING PROVIDERS.—In the case of each
participating provider, a description of the creden-
tials of the provider.
(5) CONFIDENTIALITY
POLICIES
AND
PROCE-
DURES.—A description of the policies and proce-
dures established to carry out section 122.
(6) FORMULARY RESTRICTIONS.—A description
of the nature of any drug formula restrictions.
(7) PARTICIPATING PROVIDER LIST.—A list of
current participating health care providers.
(d) FORM OF DISCLOSURE.—
(1) UNIFORMITY.—Information required to be
disclosed under this section shall be provided in ac-
cordance with uniform, national reporting standards
specified by the Secretary, after consultation with
applicable State authorities, so that prospective en-
rollees may compare the attributes of different
issuers and coverage offered within an area.
(2) INFORMATION INTO HANDBOOK.—Nothing
in this section shall be construed as preventing a
group health plan or health insurance issuer from
making the information under subsections (b) and
(c) available to participants, beneficiaries, and en-
rollees through an enrollee handbook or similar pub-
lication.
(3) UPDATING
PARTICIPATING
PROVIDER
IN-
FORMATION.—The 
information 
on 
participating
health care providers described in subsection
(b)(3)(C) shall be updated within such reasonable
period as determined appropriate by the Secretary.
Nothing in this section shall prevent an issuer from
changing or updating other information made avail-
able under this section.
(e) CONSTRUCTION.—Nothing in this section shall be
construed as requiring public disclosure of individual con-
tracts or financial arrangements between a group health
plan or health insurance issuer and any provider.
SEC. 122. PROTECTION OF PATIENT CONFIDENTIALITY.
Insofar as a group health plan, or a health insurance
issuer that offers health insurance coverage, maintains
medical records or other health information regarding par-
ticipants, beneficiaries, and enrollees, the plan or issuer
shall establish procedures—
(1) to safeguard the privacy of any individually
identifiable enrollee information;
(2) to maintain such records and information in
a manner that is accurate and timely, and
(3) to assure timely access of such individuals
to such records and information.
SEC. 123. HEALTH INSURANCE OMBUDSMEN.
(a) IN GENERAL.—Each State that obtains a grant
under subsection (c) shall provide for creation and oper-
ation of a Health Insurance Ombudsman through a con-
tract with a not-for-profit organization that operates inde-
pendent of group health plans and health insurance
issuers. Such Ombudsman shall be responsible for at least
the following:
(1) To assist consumers in the State in choos-
ing among health insurance coverage or among cov-
erage options offered within group health plans.
(2) To provide counseling and assistance to en-
rollees dissatisfied with their treatment by health in-
surance issuers and group health plans in regard to
such coverage or plans and with respect to griev-
ances and appeals regarding determinations under
such coverage or plans.
(b) FEDERAL ROLE.—In the case of any State that
does not provide for such an Ombudsman under sub-
section (a), the Secretary shall provide for the creation
and operation of a Health Insurance Ombudsman through
a contract with a not-for-profit organization that operates
independent of group health plans and health insurance
issuers and that is responsible for carrying out with re-
spect to that State the functions otherwise provided under
subsection (a) by a Health Insurance Ombudsman.
(c) AUTHORIZATION
OF APPROPRIATIONS.—There
are authorized to be appropriated to the Secretary of
Health and Human Services such amounts as may be nec-
essary to provide for grants to States for contracts for
Health Insurance Ombudsmen under subsection (a) or
contracts for such Ombudsmen under subsection (b).
(d) CONSTRUCTION.—Nothing in this section shall be
construed to prevent the use of other forms of enrollee
assistance.
Subtitle D—Grievance and Appeals
Procedures
SEC. 131. ESTABLISHMENT OF GRIEVANCE PROCESS.
(a) ESTABLISHMENT OF GRIEVANCE SYSTEM.—
(1) IN GENERAL.—A group health plan, and a
health insurance issuer in connection with the provi-
sion of health insurance coverage, shall establish and
maintain a system to provide for the presentation
and resolution of oral and written grievances
brought by individuals who are participants, bene-
ficiaries, or enrollees, or health care providers or
other individuals acting on behalf of an individual
and with the individual’s consent, regarding any as-
pect of the plan’s or issuer’s services.
(2) SCOPE.—The system shall include griev-
ances regarding access to and availability of services,
quality of care, choice and accessibility of providers,
network adequacy, and compliance with the require-
ments of this title.
(b) GRIEVANCE SYSTEM.—Such system shall include
the following components with respect to individuals who
are participants, beneficiaries, or enrollees:
(1) Written notification to all such individuals
and providers of the telephone numbers and business
addresses of the plan or issuer personnel responsible
for resolution of grievances and appeals.
(2) A system to record and document, over a
period of at least 3 previous years, all grievances
and appeals made and their status.
(3) A process providing for timely processing
and resolution of grievances.
(4) Procedures for follow-up action, including
the methods to inform the person making the griev-
ance of the resolution of the grievance.
(5) Notification to the continuous quality im-
provement program under section 111(a) of all
grievances and appeals relating to quality of care.
SEC. 132. INTERNAL APPEALS OF ADVERSE DETERMINA-
TIONS.
(a) RIGHT OF APPEAL.—
(1) IN GENERAL.—A participant or beneficiary
in a group health plan, and an enrollee in health in-
surance coverage offered by a health insurance
issuer, and any provider or other person acting on
behalf of such an individual with the individual’s
consent, may appeal any appealable decision (as de-
fined in paragraph (2)) under the procedures de-
scribed in this section and (to the extent applicable)
section 133. Such individuals and providers shall be
provided with a written explanation of the appeal
process and the determination upon the conclusion
of the appeals process and as provided in section
121(b)(8).
(2) APPEALABLE DECISION DEFINED.—In this
section, the term ‘‘appealable decision’’ means any of
the following:
(A) Denial, reduction, or termination of, or
failure to provide or make payment (in whole or
in part) for, a benefit, including a failure to
cover an item or service for which benefits are
otherwise provided because it is determined to
be experimental or investigational or not medi-
cally necessary or appropriate.
(B) Failure to provide coverage of emer-
gency services or reimbursement of mainte-
nance care or post-stabilization care under sec-
tion 101.
(C) Failure to provide a choice of provider
under section 103.
(D) Failure to provide qualified health care
providers under section 103.
(E) Failure to provide access to specialty
and other care under section 104.
(F) Failure to provide continuation of care
under section 105.
(G) Failure to provide coverage of routine
patient costs in connection with an approval
clinical trial under section 106.
(H) Failure to provide access to needed
drugs under section 107(a)(3) or 107(b).
(I) Discrimination in delivery of services in
violation of section 109.
(J) An adverse determination under a utili-
zation review program under section 115.
(K) The imposition of a limitation that is
prohibited under section 151.
(b) INTERNAL APPEAL PROCESS.—
(1) IN GENERAL.—Each group health plan and
health insurance issuer shall establish and maintain
an internal appeal process under which any partici-
pant, beneficiary, enrollee, or provider acting on be-
half of such an individual with the individual’s con-
sent, who is dissatisfied with any appealable decision
has the opportunity to appeal the decision through
an internal appeal process. The appeal may be com-
municated orally.
(2) CONDUCT OF REVIEW.—
(A) IN GENERAL.—The process shall in-
clude a review of the decision by a physician or
other health care professional (or professionals)
who has been selected by the plan or issuer and
who has not been involved in the appealable de-
cision at issue in the appeal.
(B) AVAILABILITY AND PARTICIPATION OF
CLINICAL PEERS.—The individuals conducting
such review shall include one or more clinical
peers (as defined in section 191(c)(2)) who have
not been involved in the appealable decision at
issue in the appeal.
(3) DEADLINE.—
(A) IN GENERAL.—Subject to subsection
(c), the plan or issuer shall conclude each ap-
peal as soon as possible after the time of the re-
ceipt of the appeal in accordance with medical
exigencies of the case involved, but in no event
later than—
(i) 72 hours after the time of receipt
of an expedited appeal, and
(ii) except as provided in subpara-
graph (B), 15 business days after such
time in the case of all other appeals.
(B) EXTENSION.—A group health plan or
health insurance issuer may extend the deadline
for an appeal that does not relate to a decision
regarding an expedited appeal and that does
not involve medical exigencies up to an addi-
tional 10 business days where it can dem-
onstrate to the applicable authority reasonable
cause for the delay beyond its control and
where it provides, within the original deadline
under subparagraph (A), a written progress re-
port and explanation for the delay to such au-
thority and to the participant, beneficiary, or
enrollee and provider involved.
(4) NOTICE.—If a plan or issuer denies an ap-
peal, the plan or issuer shall provide the participant,
beneficiary, or enrollee and provider involved with
notice in printed form of the denial and the reasons
therefore, together with a notice in printed form of
rights to any further appeal.
(c) EXPEDITED REVIEW PROCESS.—
(1) IN GENERAL.—A group health plan, and a
health insurance issuer, shall establish procedures in
writing for the expedited consideration of appeals
under subsection (b) in situations in which the appli-
cation of the normal timeframe for making a deter-
mination could seriously jeopardize the life or health
of the participant, beneficiary, or enrollee or such an
individual’s ability to regain maximum function.
(2) PROCESS.—Under such procedures—
(A) the request for expedited appeal may
be submitted orally or in writing by an individ-
ual or provider who is otherwise entitled to re-
quest the appeal;
(B) all necessary information, including
the plan’s or issuer’s decision, shall be trans-
mitted between the plan or issuer and the re-
quester by telephone, facsimile, or other simi-
larly expeditious available method; and
(C) the plan or issuer shall expedite the
appeal if the request for an expedited appeal is
submitted under subparagraph (A) by a physi-
cian and the request indicates that the situation
described in paragraph (1) exists.
(d) DIRECT USE OF FURTHER APPEALS.—In the
event that the plan or issuer fails to comply with any of
the deadlines for completion of appeals under this section
or in the event that the plan or issuer for any reason ex-
pressly waives its rights to an internal review of an appeal
under subsection (b), the participant, beneficiary, or en-
rollee involved and the provider involved shall be relieved
of any obligation to complete the appeal involved and may,
at such an individual’s or provider’s option, proceed di-
rectly to seek further appeal through any applicable exter-
nal appeals process.
SEC. 133. EXTERNAL APPEALS OF ADVERSE DETERMINA-
TIONS.
(a) RIGHT TO EXTERNAL APPEAL.—
(1) IN GENERAL.—A group health plan, and a
health insurance issuer offering group health insur-
ance coverage, shall provide for an external appeals
process that meets the requirements of this section
in the case of an externally appealable decision de-
scribed in paragraph (2). The appropriate Secretary
shall establish standards to carry out such require-
ments.
(2) EXTERNALLY APPEALABLE DECISION DE-
FINED.—For purposes of this section, the term ‘‘ex-
ternally appealable decision’’ means an appealable
decision (as defined in section 132(a)(2)) if—
(A) the amount involved exceeds a signifi-
cant threshold; or
(B) the patient’s life or health is jeopard-
ized as a consequence of the decision.
Such term does not include a denial of coverage for
services that are specifically listed in plan or cov-
erage documents as excluded from coverage.
(3) EXHAUSTION OF INTERNAL APPEALS PROC-
ESS.—A plan or issuer may condition the use of an
external appeal process in the case of an externally
appealable decision upon completion of the internal
review process provided under section 132, but only
if the decision is made in a timely basis consistent
with the deadlines provided under this subtitle.
(b) GENERAL ELEMENTS OF EXTERNAL APPEALS
PROCESS.—
(1) CONTRACT WITH QUALIFIED EXTERNAL AP-
PEAL ENTITY.—
(A) CONTRACT REQUIREMENT.—Subject to
subparagraph (B), the external appeal process
under this section of a plan or issuer shall be
conducted under a contract between the plan or
issuer and one or more qualified external appeal
entities (as defined in subsection (c)).
(B) RESTRICTIONS ON QUALIFIED EXTER-
NAL APPEAL ENTITY.—
(i) BY
STATE
FOR
HEALTH
INSUR-
ANCE ISSUERS.—With respect to health in-
surance issuers in a State, the State may
provide for external review activities to be
conducted by a qualified external appeal
entity that is designated by the State or
that is selected by the State in such a
manner as to assure an unbiased deter-
mination.
(ii) BY FEDERAL GOVERNMENT FOR
GROUP HEALTH PLANS.—With respect to
group health plans, the appropriate Sec-
retary may exercise the same authority as
a State may exercise with respect to health
insurance issuers under clause (i). Such
authority may include requiring the use of
the qualified external appeal entity des-
ignated or selected under such clause.
(iii) LIMITATION ON PLAN OR ISSUER
SELECTION.—If an applicable authority
permits more than one entity to qualify as
a qualified external appeal entity with re-
spect to a group health plan or health in-
surance issuer and the plan or issuer may
select among such qualified entities, the
applicable authority—
(I) shall assure that the selection
process will not create any incentives
for external appeal entities to make a
decision in a biased manner, and
(II) shall implement procedures
for auditing a sample of decisions by
such entities to assure that no such
decisions are made in a biased man-
ner.
(C) OTHER
TERMS
AND
CONDITIONS.—
The terms and conditions of a contract under
this paragraph shall be consistent with the
standards the appropriate Secretary shall estab-
lish to assure there is no real or apparent con-
flict of interest in the conduct of external ap-
peal activities. Such contract shall provide that
the direct costs of the process (not including
costs of representation of a participant, bene-
ficiary, or enrollee) shall be paid by the plan or
issuer, and not by the participant, beneficiary,
or enrollee.
(2) ELEMENTS OF PROCESS.—An external ap-
peal process shall be conducted consistent with
standards established by the appropriate Secretary
that include at least the following:
(A) FAIR PROCESS; DE NOVO DETERMINA-
TION.—The process shall provide for a fair, de
novo determination.
(B) DETERMINATION CONCERNING EXTER-
NALLY
APPEALABLE
DECISIONS.—A qualified
external appeal entity shall determine whether a
decision is an externally appealable decision and
related decisions, including—
(i) whether such a decision involves an
expedited appeal;
(ii) the appropriate deadlines for in-
ternal review process required due to medi-
cal exigencies in a case; and
(iii) whether such a process has been
completed.
(C) OPPORTUNITY TO SUBMIT EVIDENCE,
HAVE
REPRESENTATION, 
AND
MAKE
ORAL
PRESENTATION.—Each party to an externally
appealable decision—
(i) may submit and review evidence
related to the issues in dispute,
(ii) may use the assistance or rep-
resentation of one or more individuals (any
of whom may be an attorney), and
(iii) may make an oral presentation.
(D) PROVISION
OF
INFORMATION.—The
plan or issuer involved shall provide timely ac-
cess to all its records relating to the matter of
the externally appealable decision and to all
provisions of the plan or health insurance cov-
erage (including any coverage manual) relating
to the matter.
(E) TIMELY DECISIONS.—A determination
by the external appeal entity on the decision
shall—
(i) be made orally or in writing and,
if it is made orally, shall be supplied to the
parties in writing as soon as possible;
(ii) be binding on the plan or issuer;
(iii) be made in accordance with the
medical exigencies of the case involved, but
in no event later than 60 days (or 72
hours in the case of an expedited appeal)
from the date of completion of the filing of
notice of external appeal of the decision;
(iv) state, in layperson’s language, the
basis for the determination, including, if
relevant, any basis in the terms or condi-
tions of the plan or coverage; and
(v) inform the participant, beneficiary,
or enrollee of the individual’s rights to seek
further review by the courts (or other proc-
ess) of the external appeal determination.
(c) QUALIFICATIONS OF EXTERNAL APPEAL ENTI-
TIES.—
(1) IN GENERAL.—For purposes of this section,
the term ‘‘qualified external appeal entity’’ means,
in relation to a plan or issuer, an entity (which may
be a governmental entity) that is certified under
paragraph (2) as meeting the following require-
ments:
(A) There is no real or apparent conflict of
interest that would impede the entity conduct-
ing external appeal activities independent of the
plan or issuer.
(B) The entity conducts external appeal
activities through clinical peers.
(C) The entity has sufficient medical, legal,
and other expertise and sufficient staffing to
conduct external appeal activities for the plan
or issuer on a timely basis consistent with sub-
section (b)(3)(E).
(D) The entity meets such other require-
ments as the appropriate Secretary may im-
pose.
(2) CERTIFICATION OF EXTERNAL APPEAL EN-
TITIES.—
(A) IN GENERAL.—In order to be treated
as a qualified external appeal entity with re-
spect to—
(i) a group health plan, the entity
must be certified (and, in accordance with
subparagraph (B), periodically recertified)
as meeting the requirements of paragraph
(1) by the Secretary of Labor (or under a
process recognized or approved by the Sec-
retary of Labor); or
(ii) a health insurance issuer operat-
ing in a State, the entity must be certified
(and, in accordance with subparagraph
(B), periodically recertified) as meeting
such requirements by the applicable State
authority (or, if the States has not estab-
lished an adequate certification and recer-
tification process, by the Secretary of
Health and Human Services, or under a
process recognized or approved by such
Secretary).
(B) RECERTIFICATION PROCESS.—The ap-
propriate Secretary shall develop standards for
the recertification of external appeal entities.
Such standards shall include a specification
of—
(i) the information required to be sub-
mitted as a condition of recertification on
the entity’s performance of external appeal
activities, which information shall include
the number of cases reviewed, a summary
of the disposition of those cases, the length
of time in making determinations on those
cases, and such information as may be nec-
essary to assure the independence of the
entity from the plans or issuers for which
external appeal activities are being con-
ducted; and
(ii) the periodicity which recertifi-
cation will be required.
(d) CONTINUING LEGAL RIGHTS OF ENROLLEES.—
Nothing in this title shall be construed as removing any
legal rights of participants, beneficiaries, enrollees, and
others under State or Federal law, including the right to
file judicial actions to enforce rights.
Subtitle E—Protecting the Doctor-
Patient Relationship
SEC. 141. PROHIBITION OF INTERFERENCE WITH CERTAIN
MEDICAL COMMUNICATIONS.
(a) PROHIBITION.—
(1) GENERAL
RULE.—The provisions of any
contract or agreement, or the operation of any con-
tract or agreement, between a group health plan or
health insurance issuer in relation to health insur-
ance coverage (including any partnership, associa-
tion, or other organization that enters into or ad-
ministers such a contract or agreement) and a
health care provider (or group of health care provid-
ers) shall not prohibit or restrict the provider from
engaging in medical communications with the pro-
vider’s patient.
(2) NULLIFICATION.—Any contract provision or
agreement described in paragraph (1) shall be null
and void.
(b) RULES OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed—
(1) to prohibit the enforcement, as part of a
contract or agreement to which a health care pro-
vider is a party, of any mutually agreed upon terms
and conditions, including terms and conditions re-
quiring a health care provider to participate in, and
cooperate with, all programs, policies, and proce-
dures developed or operated by a group health plan
or health insurance issuer to assure, review, or im-
prove the quality and effective utilization of health
care services (if such utilization is according to
guidelines or protocols that are based on clinical or
scientific evidence and the professional judgment of
the provider) but only if the guidelines or protocols
under such utilization do not prohibit or restrict
medical communications between providers and their
patients; or
(2) to permit a health care provider to mis-
represent the scope of benefits covered under the
group health plan or health insurance coverage or to
otherwise require a group health plan health insur-
ance issuer to reimburse providers for benefits not
covered under the plan or coverage.
(c) MEDICAL COMMUNICATION DEFINED.—In this
section:
(1) IN GENERAL.—The term ‘‘medical commu-
nication’’ means any communication made by a
health care provider with a patient of the health care
provider (or the guardian or legal representative of
such patient) with respect to—
(A) the patient’s health status, medical
care, or treatment options;
(B) any utilization review requirements
that may affect treatment options for the pa-
tient; or
(C) any financial incentives that may af-
fect the treatment of the patient.
(2) MISREPRESENTATION.—The term ‘‘medical
communication’’ does not include a communication
by a health care provider with a patient of the
health care provider (or the guardian or legal rep-
resentative of such patient) if the communication in-
volves a knowing or willful misrepresentation by
such provider.
SEC. 142. PROHIBITION AGAINST TRANSFER OF INDEM-
NIFICATION OR IMPROPER INCENTIVE AR-
RANGEMENTS.
(a) PROHIBITION OF TRANSFER OF INDEMNIFICA-
TION.—
(1) IN GENERAL.—No contract or agreement
between a group health plan or health insurance
issuer (or any agent acting on behalf of such a plan
or issuer) and a health care provider shall contain
any provision purporting to transfer to the health
care provider by indemnification or otherwise any li-
ability relating to activities, actions, or omissions of
the plan, issuer, or agent (as opposed to the pro-
vider).
(2) NULLIFICATION.—Any contract or agree-
ment provision described in paragraph (1) shall be
null and void.
(b) PROHIBITION OF IMPROPER PHYSICIAN INCEN-
TIVE PLANS.—
(1) 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
1876(i)(8) of the Social Security Act) unless the re-
quirements described in subparagraph (A) of such
section are met with respect to such a plan.
(2) APPLICATION.—For purposes of carrying
out paragraph (1), any reference in section
1876(i)(8) of the Social Security Act to the Sec-
retary, an eligible organization, or an individual en-
rolled with the organization shall be treated as a ref-
erence to the applicable authority, a group health
plan or health insurance issuer, respectively, and a
participant, beneficiary, or enrollee with the plan or
organization, respectively.
SEC. 143. ADDITIONAL RULES REGARDING PARTICIPATION
OF HEALTH CARE PROFESSIONALS.
(a) PROCEDURES.—Insofar as a group health plan,
or health insurance issuer that offers health insurance cov-
erage, provides benefits through participating health care
professionals, the plan or issuer shall establish reasonable
procedures relating to the participation (under an agree-
ment between a professional and the plan or issuer) of
such professionals under the plan or coverage. Such proce-
dures shall include—
(1) providing notice of the rules regarding par-
ticipation;
(2) providing written notice of participation de-
cisions that are adverse to professionals; and
(3) providing a process within the plan or issuer
for appealing such adverse decisions, including the
presentation of information and views of the profes-
sional regarding such decision.
(b) CONSULTATION IN MEDICAL POLICIES.—A group
health plan, and health insurance issuer that offers health
insurance coverage, shall consult with participating physi-
cians (if any) regarding the plan’s or issuer’s medical pol-
icy, quality, and medical management procedures.
SEC. 144. 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 or
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-
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—
(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 or 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
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
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.
(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 establish-
ing and enforcing reasonable peer review or uti-
lization review protocols or determining whether
a protected health care professional has com-
plied with those protocols or from establishing
and enforcing internal procedures for the pur-
pose 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
(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 F—Promoting Good
Medical Practice
SEC. 151. PROMOTING GOOD MEDICAL PRACTICE.
(a) PROHIBITING ARBITRARY LIMITATIONS OR CON-
DITIONS FOR THE PROVISION OF SERVICES.—
(1) IN GENERAL.—A group health plan, and a
health insurance issuer in connection with the provi-
sion of health insurance coverage, may not arbitrar-
ily interfere with or alter the decision of the treating
physician regarding the manner or setting in which
particular services are delivered if the services are
medically necessary or appropriate for treatment or
diagnosis to the extent that such treatment or diag-
nosis is otherwise a covered benefit.
(2) CONSTRUCTION.—Paragraph (1) shall not
be construed as prohibiting a plan or issuer from
limiting the delivery of services to one or more
health care providers within a network of such pro-
viders.
(b) NO CHANGE IN COVERAGE.—Subsection (a) shall
not be construed as requiring coverage of particular serv-
ices the coverage of which is otherwise not covered under
the terms of the plan or coverage or from conducting utili-
zation review activities consistent with this subsection.
(c) MEDICAL NECESSITY OR APPROPRIATENESS DE-
FINED.—In subsection (a), the term ‘‘medically necessary
or appropriate’’ means, with respect to a service or benefit,
a service or benefit which is consistent with generally ac-
cepted principles of professional medical practice.
SEC. 152. STANDARDS RELATING TO BENEFITS FOR CER-
TAIN BREAST CANCER TREATMENT.
(a) REQUIREMENTS FOR MINIMUM HOSPITAL STAY
FOLLOWING MASTECTOMY
OR LYMPH NODE DISSEC-
TION.—
(1) IN GENERAL.—A group health plan, and a
health insurance issuer offering group health insur-
ance coverage, may not—
(A) except as provided in paragraph (2)—
(i) restrict benefits for any hospital
length of stay in connection with a mastec-
tomy for the treatment of breast cancer to
less than 48 hours, or
(ii) restrict benefits for any hospital
length of stay in connection with a lymph
node dissection for the treatment of breast
cancer to less than 24 hours, or
(B) require that a provider obtain author-
ization from the plan or the issuer for prescrib-
ing any length of stay required under subpara-
graph (A) (without regard to paragraph (2)).
(2) EXCEPTION.—Paragraph (1)(A) shall not
apply in connection with any group health plan or
health insurance issuer in any case in which the de-
cision to discharge the woman involved prior to the
expiration of the minimum length of stay otherwise
required under paragraph (1)(A) is made by the at-
tending provider in consultation with the woman or
in a case involving a partial mastectomy without
lymph node dissection.
(b) PROHIBITIONS.—A group health plan, and a
health insurance issuer offering group health insurance
coverage in connection with a group health plan, may
not—
(1) deny to a woman eligibility, or continued
eligibility, to enroll or to renew coverage under the
terms of the plan, solely for the purpose of avoiding
the requirements of this section;
(2) provide monetary payments or rebates to
women to encourage such women to accept less than
the minimum protections available under this sec-
tion;
(3) penalize or otherwise reduce or limit the re-
imbursement of an attending provider because such
provider provided care to an individual participant
or beneficiary in accordance with this section;
(4) provide incentives (monetary or otherwise)
to an attending provider to induce such provider to
provide care to an individual participant or bene-
ficiary in a manner inconsistent with this section; or
(5) subject to subsection (c)(3), restrict benefits
for any portion of a period within a hospital length
of stay required under subsection (a) in a manner
which is less favorable than the benefits provided for
any preceding portion of such stay.
(c) RULES OF CONSTRUCTION.—
(1) Nothing in this section shall be construed to
require a woman who is a participant or bene-
ficiary—
(A) to undergo a mastectomy or lymph
node dissection in a hospital; or
(B) to stay in the hospital for a fixed pe-
riod of time following a mastectomy or lymph
node dissection.
(2) This section shall not apply with respect to
any group health plan, or any group health insur-
ance coverage offered by a health insurance issuer,
which does not provide benefits for hospital lengths
of stay in connection with a mastectomy or lymph
node dissection for the treatment of breast cancer.
(3) Nothing in this section shall be construed as
preventing a group health plan or issuer from impos-
ing deductibles, coinsurance, or other cost-sharing in
relation to benefits for hospital lengths of stay in
connection with a mastectomy or lymph node dissec-
tion for the treatment of breast cancer under the
plan (or under health insurance coverage offered in
connection with a group health plan), except that
such coinsurance or other cost-sharing for any por-
tion of a period within a hospital length of stay re-
quired under subsection (a) may not be greater than
such coinsurance or cost-sharing for any preceding
portion of such stay.
(d) LEVEL AND TYPE OF REIMBURSEMENTS.—Noth-
ing in this section shall be construed to prevent a group
health plan or a health insurance issuer offering group
health insurance coverage from negotiating the level and
type of reimbursement with a provider for care provided
in accordance with this section.
(e) EXCEPTION FOR HEALTH INSURANCE COVERAGE
IN CERTAIN STATES.—
(1) IN
GENERAL.—The requirements of this
section shall not apply with respect to health insur-
ance coverage if there is a State law (as defined in
section 2723(d)(1) of the Public Health Service Act)
for a State that regulates such coverage that is de-
scribed in any of the following subparagraphs:
(A) Such State law requires such coverage
to provide for at least a 48-hour hospital length
of stay following a mastectomy performed for
treatment of breast cancer and at least a 24-
hour hospital length of stay following a lymph
node dissection for treatment of breast cancer.
(B) Such State law requires, in connection
with such coverage for surgical treatment of
breast cancer, that the hospital length of stay
for such care is left to the decision of (or re-
quired to be made by) the attending provider in
consultation with the woman involved.
(2) CONSTRUCTION.—Section 2723(a)(1) of the
Public Health Service Act and section 731(a)(1) of
the Employee Retirement Income Security Act of
1974 shall not be construed as superseding a State
law described in paragraph (1).
SEC. 153. STANDARDS RELATING TO BENEFITS FOR RECON-
STRUCTIVE BREAST SURGERY.
(a) REQUIREMENTS FOR RECONSTRUCTIVE BREAST
SURGERY.—
(1) IN GENERAL.—A group health plan, and a
health insurance issuer offering group health insur-
ance coverage, that provides coverage for breast sur-
gery in connection with a mastectomy shall provide
coverage for reconstructive breast surgery resulting
from the mastectomy. Such coverage shall include
coverage for all stages of reconstructive breast sur-
gery performed on a nondiseased breast to establish
symmetry with the diseased when reconstruction on
the diseased breast is performed and coverage of
prostheses and complications of mastectomy includ-
ing lymphedema.
(2) RECONSTRUCTIVE
BREAST
SURGERY
DE-
FINED.—In this section, the term ‘‘reconstructive
breast surgery’’ means surgery performed as a result
of a mastectomy to reestablish symmetry between
two 
breasts, 
and 
includes 
augmentation
mammoplasty, 
reduction 
mammoplasty, 
and
mastopexy.
(3) MASTECTOMY
DEFINED.—In this section,
the term ‘‘mastectomy’’ means the surgical removal
of all or part of a breast.
(b) PROHIBITIONS.—
(1) DENIAL OF COVERAGE BASED ON COSMETIC
SURGERY.—A group health plan, and a health insur-
ance issuer offering group health insurance coverage
in connection with a group health plan, may not
deny coverage described in subsection (a)(1) on the
basis that the coverage is for cosmetic surgery.
(2) APPLICATION OF SIMILAR PROHIBITIONS.—
Paragraphs (2) through (5) of section 152 shall
apply under this section in the same manner as they
apply with respect to section 152.
(c) RULES OF CONSTRUCTION.—
(1) Nothing in this section shall be construed to
require a woman who is a participant or beneficiary
to undergo reconstructive breast surgery.
(2) This section shall not apply with respect to
any group health plan, or any group health insur-
ance coverage offered by a health insurance issuer,
which does not provide benefits for mastectomies.
(3) Nothing in this section shall be construed as
preventing a group health plan or issuer from impos-
ing deductibles, coinsurance, or other cost-sharing in
relation to benefits for reconstructive breast surgery
under the plan (or under health insurance coverage
offered in connection with a group health plan), ex-
cept that such coinsurance or other cost-sharing for
any portion may not be greater than such coinsur-
ance or cost-sharing that is otherwise applicable with
respect to benefits for mastectomies.
(e) LEVEL AND TYPE OF REIMBURSEMENTS.—Noth-
ing in this section shall be construed to prevent a group
health plan or a health insurance issuer offering group
health insurance coverage from negotiating the level and
type of reimbursement with a provider for care provided
in accordance with this section.
(f) EXCEPTION FOR HEALTH INSURANCE COVERAGE
IN CERTAIN STATES.—
(1) IN
GENERAL.—The requirements of this
section shall not apply with respect to health insur-
ance coverage if there is a State law (as defined in
section 2723(d)(1) of the Public Health Service Act)
for a State that regulates such coverage and that re-
quires coverage of at least the coverage of recon-
structive breast surgery otherwise required under
this section.
(2) CONSTRUCTION.—Section 2723(a)(1) of the
Public Health Service Act and section 731(a)(1) of
the Employee Retirement Income Security Act of
1974 shall not be construed as superseding a State
law described in paragraph (1).
Subtitle G—Definitions
SEC. 191. DEFINITIONS.
(a) INCORPORATION OF GENERAL DEFINITIONS.—
The provisions of section 2971 of the Public Health Serv-
ice Act shall apply for purposes 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 Secretary of the Treasury 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 Serv-
ice Act, the Secretary of Labor in relation to carrying out
this title under section 713 of the Employee Retirement
Income Security Act of 1974, and the Secretary of the
Treasury in relation to carrying out this title under chap-
ter 100 and section 4980D of the Internal Revenue Code
of 1986.
(c) ADDITIONAL DEFINITIONS.—For purposes of this
title:
(1) APPLICABLE AUTHORITY.—The term ‘‘ap-
plicable authority’’ means—
(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) CLINICAL PEER.—The term ‘‘clinical peer’’
means, with respect to a review or appeal, a physi-
cian (allopathic or osteopathic) or other health care
professional who holds a non-restricted license in a
State and who is appropriately credentialed in the
same or similar specialty as typically manages the
medical condition, procedure, or treatment under re-
view or appeal and includes a pediatric specialist
where appropriate; except that only a physician may
be a clinical peer with respect to the review or ap-
peal of treatment rendered by a physician.
(3) HEALTH
CARE
PROVIDER.—The term
‘‘health care provider’’ includes a physician or other
health care professional, as well as an institutional
provider of health care services.
(4) 
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.
(5) PARTICIPATING.—The term ‘‘participating’’
mean, 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.
SEC. 192. 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,
or continues in effect any standard or requirement
solely relating to health insurance issuers in connec-
tion with group health insurance coverage except to
the extent that such standard or requirement pre-
vents 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.
(b) RULES OF CONSTRUCTION.—Except as provided
in sections 152 and 153, nothing in this title shall be con-
strued as requiring a group health plan or health insur-
ance coverage to provide specific benefits under the terms
of such plan or coverage.
(c) 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 Northern Mariana Islands, any political
subdivisions of a State or such Islands, or any agen-
cy or instrumentality of either.
SEC. 193. 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.
TITLE II—APPLICATION OF PA-
TIENT PROTECTION STAND-
ARDS 
TO 
GROUP 
HEALTH
PLANS AND HEALTH INSUR-
ANCE 
COVERAGE 
UNDER
PUBLIC 
HEALTH 
SERVICE
ACT
SEC. 201. APPLICATION TO GROUP HEALTH PLANS AND
GROUP HEALTH INSURANCE COVERAGE.
(a) IN GENERAL.—Subpart 2 of part A of title
XXVII of the Public Health Service Act is amended by
adding at the end the following new section:
‘‘SEC. 2706. PATIENT PROTECTION STANDARDS.
‘‘(a) IN GENERAL.—Each group health plan shall
comply with patient protection requirements under title I
of the Patients’ Bill of Rights Act of 1998, and each
health insurance issuer shall comply with patient protec-
tion 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) NOTICE.—A group health plan shall comply with
the notice requirement under section 711(d) of the Em-
ployee Retirement Income Security Act of 1974 with re-
spect to the requirements referred to in subsection (a) and
a health insurance issuer shall comply with such notice
requirement as if such section applied to such issuer and
such issuer were a group health plan.’’.
(b) 
CONFORMING
AMENDMENT.—Section
2721(b)(1)(A) of such Act (42 U.S.C. 300gg–21(b)(1)(A))
is amended by inserting ‘‘(other than section 2706)’’ 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 2751 the follow-
ing new section:
100
‘‘SEC. 2752. PATIENT PROTECTION STANDARDS.
‘‘(a) IN GENERAL.—Each health insurance issuer
shall comply with patient protection requirements under
title I of the Patients’ Bill of Rights Act of 1998 with
respect to individual health insurance coverage it offers,
and such requirements shall be deemed to be incorporated
into this subsection.
‘‘(b) NOTICE.—A health insurance issuer under this
part shall comply with the notice requirement under sec-
tion 711(d) of the Employee Retirement Income Security
Act of 1974 with respect to the requirements of such title
as if such section applied to such issuer and such issuer
were a group health plan.’’.
TITLE 
III—AMENDMENTS 
TO
THE EMPLOYEE RETIREMENT
INCOME SECURITY ACT OF
1974
SEC. 301. APPLICATION OF PATIENT PROTECTION STAND-
ARDS TO GROUP HEALTH PLANS AND GROUP
HEALTH INSURANCE COVERAGE UNDER THE
EMPLOYEE RETIREMENT INCOME SECURITY
ACT OF 1974.
(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:
101
‘‘SEC. 713. PATIENT PROTECTION STANDARDS.
‘‘(a) IN GENERAL.—Subject to subsection (b), a
group health plan (and a health insurance issuer offering
group health insurance coverage in connection with such
a plan) shall comply with the requirements of title I of
the Patients’ Bill of Rights Act of 1998 (as in effect as
of the date of the enactment of such Act), and such re-
quirements shall be deemed to be incorporated into this
subsection.
‘‘(b) PLAN SATISFACTION OF CERTAIN REQUIRE-
MENTS.—
‘‘(1) SATISFACTION
OF
CERTAIN
REQUIRE-
MENTS
THROUGH
INSURANCE.—For purposes of
subsection (a), insofar as a group health plan pro-
vides benefits in the form of health insurance cov-
erage through a health insurance issuer, the plan
shall be treated as meeting the following require-
ments of title I of the Patients’ Bill of Rights Act
of 1998 with respect to such benefits and not be
considered as failing to meet such requirements be-
cause of a failure of the issuer to meet such require-
ments so long as the plan sponsor or its representa-
tives did not cause such failure by the issuer:
‘‘(A) Section 101 (relating to access to
emergency care).
102
‘‘(B) Section 102(a)(1) (relating to offer-
ing option to purchase point-of-service cov-
erage), but only insofar as the plan is meeting
such requirement through an agreement with
the issuer to offer the option to purchase point-
of-service coverage under such section.
‘‘(C) Section 103 (relating to choice of pro-
viders).
‘‘(D) Section 104 (relating to access to
specialty care).
‘‘(E) Section 105(a)(1) (relating to con-
tinuity in case of termination of provider con-
tract) and section 105(a)(2) (relating to con-
tinuity in case of termination of issuer con-
tract), but only insofar as a replacement issuer
assumes the obligation for continuity of care.
‘‘(F) Section 106 (relating to coverage for
individuals participating in approved clinical
trials.)
‘‘(G) Section 107 (relating to access to
needed prescription drugs).
‘‘(H) Section 108 (relating to adequacy of
provider network).
‘‘(I) Subtitle B (relating to quality assur-
ance).
103
‘‘(J) Section 143 (relating to additional
rules regarding participation of health care pro-
fessionals).
‘‘(K) Section 152 (relating to standards re-
lating to benefits for certain breast cancer
treatment).
‘‘(L) Section 153 (relating to standards re-
lating to benefits for reconstructive breast sur-
gery).
‘‘(2) INFORMATION.—With respect to informa-
tion required to be provided or made available under
section 121, in the case of a group health plan that
provides benefits in the form of health insurance
coverage through a health insurance issuer, the Sec-
retary shall determine the circumstances under
which the plan is not required to provide or make
available the information (and is not liable for the
issuer’s failure to provide or make available the in-
formation), if the issuer is obligated to provide and
make available (or provides and makes available)
such information.
‘‘(3) GRIEVANCE
AND
INTERNAL
APPEALS.—
With respect to the grievance system and internal
appeals process required to be established under sec-
tions 131 and 132, in the case of a group health
104
plan that provides benefits in the form of health in-
surance coverage through a health insurance issuer,
the Secretary shall determine the circumstances
under which the plan is not required to provide for
such system and process (and is not liable for the
issuer’s failure to provide for such system and proc-
ess), if the issuer is obligated to provide for (and
provides for) such system and process.
‘‘(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 133, the plan shall be treat-
ed as meeting the requirement of such section and
is not liable for the entity’s failure to meet any re-
quirements under such section.
‘‘(5) APPLICATION TO PROHIBITIONS.—Pursu-
ant to rules of the Secretary, if a health insurance
issuer offers health insurance coverage in connection
with a group health plan and takes an action in vio-
lation of any of the following sections, the group
health plan shall not be liable for such violation un-
less the plan caused such violation:
‘‘(A) 
Section 
109 
(relating 
to 
non-
discrimination in delivery of services).
105
‘‘(B) Section 141 (relating to prohibition
of interference with certain medical communica-
tions).
‘‘(C) Section 142 (relating to prohibition
against transfer of indemnification or improper
incentive arrangements).
‘‘(D) Section 144 (relating to prohibition
on retaliation).
‘‘(E) Section 151 (relating to promoting
good medical practice).
‘‘(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) APPLICATION TO CERTAIN PROHIBITIONS
AGAINST RETALIATION.—With respect to compliance
with the requirements of section 144(b)(1) of the
Patients’ Bill of Rights Act of 1998, 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
106
of section 144(b)(1) of the Patients’ Bill of Rights
Act of 1998 may file with the Secretary a complaint
within 180 days of the date of the alleged retaliation
or discrimination.
‘‘(2) INVESTIGATION.—The Secretary shall in-
vestigate such complaints and shall determine if a
violation of such section has occurred and, if so,
shall issue an order to ensure that the protected
health care professional does not suffer any loss of
position, pay, or benefits in relation to the plan,
issuer, or provider involved, as a result of the viola-
tion found by the Secretary.
‘‘(d) CONFORMING REGULATIONS.—The Secretary
may issue regulations to coordinate the requirements on
group health plans under this section with the require-
ments imposed under the other provisions of this title.’’.
(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 D (and section 115) of title I of the Patients’ Bill
of Rights Act of 1998 in the case of a claims denial shall
107
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 713’’.
(2) The table of contents in section 1 of such Act
is amended by inserting after the item relating to section
712 the following new item:
‘‘Sec. 713. 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
144(b))’’ after ‘‘part 7’’.
SEC. 302. ERISA PREEMPTION NOT TO APPLY TO CERTAIN
ACTIONS INVOLVING HEALTH INSURANCE
POLICYHOLDERS.
(a) IN GENERAL.—Section 514 of the Employee Re-
tirement Income Security Act of 1974 (29 U.S.C. 1144)
is amended by adding at the end the following subsection:
‘‘(e) PREEMPTION NOT TO APPLY TO CERTAIN AC-
TIONS ARISING OUT OF PROVISION OF HEALTH BENE-
FITS.—
‘‘(1) IN GENERAL.—Except as provided in this
subsection, nothing in this title shall be construed to
invalidate, impair, or supersede any cause of action
under State law to recover damages resulting from
108
personal injury or for wrongful death against any
person—
‘‘(A) in connection with the provision of in-
surance, administrative services, or medical
services by such person to or for a group health
plan (as defined in section 733), or
‘‘(B) that arises out of the arrangement by
such person for the provision of such insurance,
administrative services, or medical services by
other persons.
‘‘(2) EXCEPTION FOR EMPLOYERS AND OTHER
PLAN SPONSORS.—
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), paragraph (1) does not authorize—
‘‘(i) any cause of action against an
employer or other plan sponsor maintain-
ing the group health plan, or
‘‘(ii) a right of recovery or indemnity
by a person against an employer or other
plan sponsor for damages assessed against
the person pursuant to a cause of action
under paragraph (1).
‘‘(B) SPECIAL RULE.—Subparagraph (A)
shall not preclude any cause of action described
109
in paragraph (1) against an employer or other
plan sponsor if—
‘‘(i) such action is based on the em-
ployer’s or other plan sponsor’s exercise of
discretionary authority to make a decision
on a claim for benefits covered under the
plan or health insurance coverage in the
case at issue; and
‘‘(ii) the exercise by such employer or
other plan sponsor of such authority re-
sulted in personal injury or wrongful
death.’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) shall apply to acts and omissions occurring
on or after the date of the enactment of this Act from
which a cause of action arises.
TITLE 
IV—APPLICATION 
TO
GROUP 
HEALTH 
PLANS
UNDER THE INTERNAL REVE-
NUE CODE OF 1986.
SEC. 401. AMENDMENTS TO THE INTERNAL REVENUE CODE
OF 1986.
Subchapter B of chapter 100 of the Internal Revenue
Code of 1986 (as amended by section 1531(a) of the Tax-
payer Relief Act of 1997) is amended—
110
(1) in the table of sections, by inserting after
the item relating to section 9812 the following new
item:
‘‘Sec. 9813. Standard relating to patient freedom of choice.’’;
and
(2) by inserting after section 9812 the follow-
ing:
‘‘SEC. 9813. STANDARD RELATING TO PATIENTS’ BILL OF
RIGHTS.
‘‘A group health plan shall comply with the require-
ments of title I of the Patients’ Bill of Rights Act of 1998
(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.’’.
TITLE V—EFFECTIVE DATES; CO-
ORDINATION IN IMPLEMEN-
TATION
SEC. 501. EFFECTIVE DATES.
(a) GROUP HEALTH COVERAGE.—
(1) IN GENERAL.—Subject to paragraph (2),
the amendments made by sections 201(a), 301, and
401 (and title I insofar as it relates to such sections)
shall apply with respect to group health plans, and
health insurance coverage offered in connection with
group health plans, for plan years beginning on or
after January 1, 1999 (in this section referred to as
111
the ‘‘general effective date’’) and also shall apply to
portions of plan years occurring on and after such
date.
(2) TREATMENT OF COLLECTIVE BARGAINING
AGREEMENTS.—In the case of a group health plan
maintained pursuant to 1 or more collective bargain-
ing agreements between employee representatives
and 1 or more employers ratified before the date of
enactment of this Act, the amendments made by sec-
tions 201(a), 301, and 401 (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 (determined without regard to any ex-
tension thereof agreed to after the date of en-
actment of this Act), or
(B) the general effective date.
For purposes of subparagraph (A), any plan amend-
ment made pursuant to a collective bargaining
agreement relating to the plan which amends the
plan solely to conform to any requirement added by
this Act shall not be treated as a termination of
such collective bargaining agreement.