184
against a person acting in the capacity of au-
thorizing a benefit determined by an external
review entity for one or more group health
plans, or health insurance issuers offering
health insurance coverage, for—
(i) any pattern or practice of repeated
refusal to authorize a benefit determined
by an external appeal entity in violation of
the terms of such a plan, coverage, or this
title; or
(ii) any pattern or practice of re-
peated violations of the requirements of
this section with respect to such plan or
plans or coverage.
(B) STANDARD OF PROOF AND AMOUNT OF
PENALTY.—Such penalty shall be payable only
upon proof by clear and convincing evidence of
such pattern or practice and shall be in an
amount not to exceed the lesser of—
(i) 25 percent of the aggregate value
of benefits shown by the appropriate Sec-
retary to have not been provided, or unlaw-
fully delayed, in violation of this section
under such pattern or practice; or
(ii) $500,000.
185
(4) REMOVAL
AND
DISQUALIFICATION.—Any
person acting in the capacity of authorizing benefits
who has engaged in any such pattern or practice de-
scribed in paragraph (3)(A) with respect to a plan
or coverage, upon the petition of the appropriate
Secretary, may be removed by the court from such
position, and from any other involvement, with re-
spect to such a plan or coverage, and may be pre-
cluded from returning to any such position or in-
volvement for a period determined by the court.
(f) PROTECTION
OF LEGAL RIGHTS.—Nothing in
this subtitle shall be construed as altering or eliminating
any cause of action or legal rights or remedies of partici-
pants, beneficiaries, enrollees, and others under State or
Federal law (including sections 502 and 503 of the Em-
ployee Retirement Income Security Act of 1974), includ-
ing the right to file judicial actions to enforce rights.
SEC. 1104. ESTABLISHMENT OF A 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-
186
ficiaries, or enrollees, or health care providers or
other individuals acting on behalf of an individual
and with the individual’s consent or without such
consent if the individual is medically unable to pro-
vide such consent, regarding any aspect of the plan’s
or issuer’s services.
(2) GRIEVANCE DEFINED.—In this section, the
term ‘‘grievance’’ means any question, complaint, or
concern brought by a participant, beneficiary or en-
rollee that is not a claim for benefits (as defined in
section 1101(f)(1)).
(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 three previous years, all grievances
and appeals made and their status.
(3) A process providing for timely processing
and resolution of grievances.
187
(4) Procedures for follow-up action, including
the methods to inform the person making the griev-
ance of the resolution of the grievance.
Grievances are not subject to appeal under the previous
provisions of this subtitle.
Subtitle B—Access to Care
SEC. 1111. CONSUMER CHOICE OPTION.
(a) IN GENERAL.—If a health insurance issuer offers
to enrollees health insurance coverage in connection with
a group health plan which provides for coverage of services
only if such services are furnished through health care
professionals and providers who are members of a network
of health care professionals and providers who have en-
tered into a contract with the issuer to provide such serv-
ices, the issuer shall also offer or arrange to be offered
to such enrollees (at the time of enrollment and during
an annual open season as provided under subsection (c))
the option of health insurance coverage which provides for
coverage of such services which are not furnished through
health care professionals and providers who are members
of such a network unless enrollees are offered such non-
network coverage through another group health plan or
through another health insurance issuer in the group mar-
ket.
188
(b) ADDITIONAL COSTS.—The amount of any addi-
tional premium charged by the health insurance issuer for
the additional cost of the creation and maintenance of the
option described in subsection (a) and the amount of any
additional cost sharing imposed under such option shall
be borne by the enrollee unless it is paid by the health
plan sponsor through agreement with the health insurance
issuer.
(c) OPEN SEASON.—An enrollee may change to the
offering provided under this section only during a time pe-
riod determined by the health insurance issuer. Such time
period shall occur at least annually.
SEC. 1112. CHOICE OF HEALTH CARE PROFESSIONAL.
(a) PRIMARY CARE.—If a group health plan, or a
health insurance issuer that offers health insurance cov-
erage, requires or provides for designation by a partici-
pant, beneficiary, or enrollee of a participating primary
care provider, then the plan or issuer shall permit each
participant, beneficiary, and enrollee to designate any par-
ticipating primary care provider who is available to accept
such individual.
(b) SPECIALISTS.—
(1) IN GENERAL.—Subject to paragraph (2), a
group health plan and a health insurance issuer that
offers health insurance coverage shall permit each
189
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 professional who
is available to accept such individual for such care.
(2) LIMITATION.—Paragraph (1) shall not
apply to specialty care if the plan or issuer clearly
informs participants, beneficiaries, and enrollees of
the limitations on choice of participating health care
professionals with respect to such care.
(3) CONSTRUCTION.—Nothing in this sub-
section shall be construed as affecting the applica-
tion of section 1114 (relating to access to specialty
care).
SEC. 1113. 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
services in an emergency department of a hospital,
the plan or issuer shall cover emergency services (as
defined in paragraph (2)(B))—
(A) without the need for any prior author-
ization determination;
190
(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
enrollee—
(i) by a nonparticipating health care
provider with or without prior authoriza-
tion; or
(ii) by a participating health care pro-
vider without prior authorization,
the participant, beneficiary, or enrollee is not
liable for amounts that exceed the amounts of
liability that would be incurred if the services
were provided by a participating health care
provider with prior authorization; and
(D) without regard to any other term or
condition of such coverage (other than exclusion
or coordination of benefits, or an affiliation or
waiting period, permitted under section 2701 of
the Public Health Service Act, section 701 of
the Employee Retirement Income Security Act
of 1974, or section 9801 of the Internal Rev-
enue Code of 1986, and other than applicable
cost-sharing).
191
(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
192
(ii) within the capabilities of the staff
and facilities available at the hospital, such
further medical examination and treatment
as are required under section 1867 of such
Act to stabilize the patient.
(C) STABILIZE.—The term ‘‘to stabilize’’
means, with respect to an emergency medical
condition, to provide such medical treatment of
the condition as may be necessary to assure,
within reasonable medical probability, that no
material deterioration of the condition is likely
to result from or occur during the transfer of
the individual from a facility.
(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) (and shall otherwise comply with the
guidelines established under section 1852(d)(2) of the So-
193
cial Security Act), if the services are maintenance care or
post-stabilization care covered under such guidelines.
SEC. 1114. ACCESS TO SPECIALTY CARE.
(a) SPECIALTY CARE FOR COVERED SERVICES.—
(1) IN GENERAL.—If—
(A) an individual is a participant or bene-
ficiary under a group health plan or an enrollee
who is covered under health insurance coverage
offered by a health insurance issuer;
(B) the individual has a condition or dis-
ease of sufficient seriousness and complexity to
require treatment by a specialist; and
(C) benefits for such treatment are pro-
vided under the plan or coverage,
the plan or issuer shall make or provide for a refer-
ral to a specialist who is available and accessible to
provide the treatment for such condition or disease.
(2) SPECIALIST
DEFINED.—For purposes of
this subsection, the term ‘‘specialist’’ means, with
respect to a condition, a health care practitioner, fa-
cility, or center that has adequate expertise through
appropriate training and experience (including, in
the case of a child, appropriate pediatric expertise)
to provide high quality care in treating the condi-
tion.
194
(3) CARE UNDER REFERRAL.—A group health
plan or health insurance issuer may require that the
care provided to an individual pursuant to such re-
ferral under paragraph (1) be—
(A) pursuant to a treatment plan, only if
the treatment plan is developed by the specialist
and approved by the plan or issuer, in consulta-
tion with the designated primary care provider
or specialist and the individual (or the individ-
ual’s designee); and
(B) in accordance with applicable quality
assurance and utilization review standards of
the plan or issuer.
Nothing in this subsection shall be construed as pre-
venting such a treatment plan for an individual from
requiring a specialist to provide the primary care
provider with regular updates on the specialty care
provided, as well as all necessary medical informa-
tion.
(4) 
REFERRALS
TO
PARTICIPATING
PRO-
VIDERS.—A group health plan or health insurance
issuer is not required under paragraph (1) to pro-
vide for a referral to a specialist that is not a par-
ticipating provider, unless the plan or issuer does
not have an appropriate specialist that is available
195
and accessible to treat the individual’s condition and
that is a participating provider with respect to such
treatment.
(5) TREATMENT
OF
NONPARTICIPATING
PRO-
VIDERS.—If a plan or issuer refers an individual to
a nonparticipating specialist pursuant to paragraph
(1), services provided pursuant to the approved
treatment plan (if any) shall be provided at no addi-
tional cost to the individual beyond what the indi-
vidual would otherwise pay for services received by
such a specialist that is a participating provider.
(b) SPECIALISTS AS GATEKEEPER FOR TREATMENT
OF ONGOING SPECIAL CONDITIONS.—
(1) IN GENERAL.—A group health plan, or a
health insurance issuer, in connection with the provi-
sion of health insurance coverage, shall have a proce-
dure by which an individual who is a participant,
beneficiary, or enrollee and who has an ongoing spe-
cial condition (as defined in paragraph (3)) may re-
quest and receive a referral to a specialist for such
condition who shall be responsible for and capable of
providing and coordinating the individual’s care with
respect to the condition. Under such procedures if
such an individual’s care would most appropriately
196
be coordinated by such a specialist, such plan or
issuer shall refer the individual to such specialist.
(2) TREATMENT FOR RELATED REFERRALS.—
Such specialists shall be permitted to treat the indi-
vidual without a referral from the individual’s pri-
mary care provider and may authorize such refer-
rals, procedures, tests, and other medical services as
the individual’s primary care provider would other-
wise be permitted to provide or authorize, subject to
the terms of the treatment (referred to in subsection
(a)(3)(A)) with respect to the ongoing special condi-
tion.
(3) ONGOING SPECIAL CONDITION DEFINED.—
In this subsection, the term ‘‘ongoing special condi-
tion’’ means a condition or disease that—
(A) is life-threatening, degenerative, or dis-
abling; and
(B) requires specialized medical care over
a prolonged period of time.
(4) TERMS OF REFERRAL.—The provisions of
paragraphs (3) through (5) of subsection (a) apply
with respect to referrals under paragraph (1) of this
subsection in the same manner as they apply to re-
ferrals under subsection (a)(1).
(c) STANDING REFERRALS.—
197
(1) IN GENERAL.—A group health plan, and a
health insurance issuer in connection with the provi-
sion of health insurance coverage, shall have a proce-
dure 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 ap-
propriate, the plan or issuer shall make such a refer-
ral to such a specialist if the individual so desires.
(2) TERMS OF REFERRAL.—The provisions of
paragraphs (3) through (5) of subsection (a) apply
with respect to referrals under paragraph (1) of this
subsection in the same manner as they apply to re-
ferrals under subsection (a)(1).
SEC. 1115. ACCESS TO OBSTETRICAL AND GYNECOLOGICAL
CARE.
(a) IN GENERAL.—If a group health plan, or a health
insurance issuer in connection with the provision of health
insurance coverage, requires or provides for a participant,
beneficiary, or enrollee to designate a participating pri-
mary care health care professional, the plan or issuer—
200
tion (as defined in paragraph (3)(A)) at the time of
such termination, the plan or issuer shall—
(A) notify the individual on a timely basis
of such termination and of the right to elect
continuation of coverage of treatment by the
provider under this section; and
(B) subject to subsection (c), permit the
individual to elect to continue to be covered
with respect to treatment by the provider of
such condition 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.
201
(3) DEFINITIONS.—For purposes of this sec-
tion:
(A) ONGOING
SPECIAL
CONDITION.—The
term ‘‘ongoing special condition’’ has the mean-
ing given such term in section 1114(b)(3), and
also includes pregnancy.
(B) TERMINATION.—The term ‘‘termi-
nated’’ 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 applica-
ble 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 up to 90 days (as deter-
mined by the treating health care professional) after
the date of the notice described in subsection
(a)(1)(A) of the provider’s termination.
(2) SCHEDULED SURGERY AND ORGAN TRANS-
PLANTATION.—If surgery or organ transplantation
was scheduled for an individual before the date of
the announcement of the termination of the provider
status under subsection (a)(1)(A) or if the individual
on such date was on an established waiting list or
202
otherwise scheduled to have such surgery or trans-
plantation, the transitional period under this sub-
section with respect to the surgery or transplan-
tation shall extend beyond the period under para-
graph (1) and until the date of discharge of the indi-
vidual after completion of the surgery or transplan-
tation.
(3) PREGNANCY.—If—
(A) a participant, beneficiary, or enrollee
was determined to be pregnant at the time of
a provider’s termination of participation; 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,
203
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 or its medical manifestations.
(c) PERMISSIBLE
TERMS
AND
CONDITIONS.—A
group health plan or health insurance issuer may condi-
tion coverage of continued treatment by a provider under
subsection (a)(1)(B) upon the individual notifying the plan
of the election of continued coverage and upon the pro-
vider agreeing to the following 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
204
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. 1118. ACCESS TO NEEDED PRESCRIPTION DRUGS.
If a group health plan, or health insurance issuer that
offers health insurance coverage, provides benefits with re-
spect 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 1121(c)(5) to participants, bene-
205
ficiaries, and enrollees, the nature of the formulary
restrictions; and
(3) consistent with the standards for a utiliza-
tion review program under section 1101, provide for
exceptions from the formulary limitation when a
non-formulary alternative is medically indicated.
SEC. 1119. 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.
206
(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.
207
(C) The individual’s participation in the trial
offers meaningful potential for significant clinical
benefit for the individual.
(2) Either—
(A) the referring physician is a partici-
pating health care professional and has con-
cluded that the individual’s participation in
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.
208
(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
209
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.
Subtitle C—Access to Information
SEC. 1121. PATIENT ACCESS TO 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;
210
(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
211
(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 nonparticipating 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;
212
(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
213
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 1112(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.
(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
214
(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.
(9) QUALITY
ASSURANCE.—Any information
made public by an accrediting organization in the
process of accreditation of the plan or issuer or any
215
additional quality indicators the plan or issuer
makes available.
(10) 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.
(11) NOTICE
OF
REQUIREMENTS.—Notice of
the requirements of this title.
(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 1101, including under any drug formulary
program under section 1118.
(2) GRIEVANCE AND APPEALS INFORMATION.—
Information on the number of grievances and ap-
peals and on the disposition in the aggregate of such
matters.
216
(3) METHOD OF PHYSICIAN COMPENSATION.—
A general description by category (including salary,
fee-for-service, capitation, and such other categories
as may be specified in regulations of the Secretary)
of the applicable method by which a specified pro-
spective or treating health care professional is (or
would be) compensated in connection with the provi-
sion of health care under the plan or 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) FORMULARY RESTRICTIONS.—A description
of the nature of any drug formula restrictions.
(6) PARTICIPATING PROVIDER LIST.—A list of
current participating health care providers.
(d) 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.
217
Subtitle D—Protecting the Doctor-
Patient Relationship
SEC. 1131. PROHIBITION OF INTERFERENCE WITH CERTAIN
MEDICAL COMMUNICATIONS.
(a) GENERAL RULE.—The provisions of any contract
or agreement, or the operation of any contract or agree-
ment, between a group health plan or health insurance
issuer in relation to health insurance coverage (including
any partnership, association, or other organization that
enters into or administers such a contract or agreement)
and a health care provider (or group of health care pro-
viders) shall not prohibit or otherwise restrict a health
care professional from advising such a participant, bene-
ficiary, or enrollee who is a patient of the professional
about the health status of the individual or medical care
or treatment for the individual’s condition or disease, re-
gardless of whether benefits for such care or treatment
are provided under the plan or coverage, if the professional
is acting within the lawful scope of practice.
(b) NULLIFICATION.—Any contract provision or
agreement that restricts or prohibits medical communica-
tions in violation of subsection (a) shall be null and void.
218
SEC. 1132. PROHIBITION OF DISCRIMINATION AGAINST
PROVIDERS BASED ON LICENSURE.
(a) IN GENERAL.—A group health plan and a health
insurance issuer offering health insurance coverage shall
not discriminate 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 license or certifi-
cation.
(b) CONSTRUCTION.—Subsection (a) shall not be
construed—
(1) as requiring the coverage under a group
health plan or health insurance coverage of par-
ticular benefits or services or to prohibit a plan or
issuer from including providers only to the extent
necessary to meet the needs of the plan’s or issuer’s
participants, beneficiaries, or enrollees or from es-
tablishing any measure designed to maintain quality
and control costs consistent with the responsibilities
of the plan or issuer;
(2) to override any State licensure or scope-of-
practice law; or
(3) as requiring a plan or issuer that offers net-
work coverage to include for participation every will-
ing provider who meets the terms and conditions of
the plan or issuer.
219
SEC. 1133. PROHIBITION AGAINST IMPROPER INCENTIVE
ARRANGEMENTS.
(a) IN GENERAL.—A group health plan and a health
insurance issuer offering health insurance coverage may
not operate any physician incentive plan (as defined in
subparagraph (B) of section 1876(i)(8) of the Social Secu-
rity Act) unless the requirements described in clauses (i),
(ii)(I), and (iii) of subparagraph (A) of such section are
met with respect to such a plan.
(b) APPLICATION.—For purposes of carrying out
paragraph (1), any reference in section 1876(i)(8) of the
Social Security Act to the Secretary, an eligible organiza-
tion, or an individual enrolled with the organization shall
be treated as a reference 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.
(c) CONSTRUCTION.—Nothing in this section shall be
construed as prohibiting all capitation and similar ar-
rangements or all provider discount arrangements.
SEC. 1134. PAYMENT OF CLAIMS.
A group health plan, and a health insurance issuer
offering group health insurance coverage, shall provide for
prompt payment of claims submitted for health care serv-
ices or supplies furnished to a participant, beneficiary, or
enrollee with respect to benefits covered by the plan or
220
issuer, in a manner consistent with the provisions of sec-
tions 1816(c)(2) and 1842(c)(2) of the Social Security Act
(42 U.S.C. 1395h(c)(2) and 42 U.S.C. 1395u(c)(2)), ex-
cept that for purposes of this section, subparagraph (C)
of section 1816(c)(2) of the Social Security Act shall be
treated as applying to claims received from a participant,
beneficiary, or enrollee as well as claims referred to in
such subparagraph.
SEC. 1135. 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—
221
(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.
222
(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-
223
tablished for the purpose of addressing quality
concerns before making the disclosure.
(3) EXCEPTION AND SPECIAL RULE.—
(A) GENERAL EXCEPTION.—Paragraph (1)
does not protect disclosures that would violate
Federal or State law or diminish or impair the
rights of any person to the continued protection
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;
224
(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.
225
(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 estab-
lishing and enforcing reasonable peer review or
utilization review protocols or determining
whether a protected health care professional has
complied with those protocols or from estab-
lishing and enforcing internal procedures for
the purpose of addressing quality concerns.
(C) RELATION TO OTHER RIGHTS.—Noth-
ing in this subsection shall be construed to
abridge rights of participants, beneficiaries, en-
rollees, and protected health care professionals
under other applicable Federal or State laws.
(7) PROTECTED HEALTH CARE PROFESSIONAL
DEFINED.—For purposes of this subsection, the
term ‘‘protected health care professional’’ means an
226
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 E—Definitions
SEC. 1151. DEFINITIONS.
(a) INCORPORATION OF GENERAL DEFINITIONS.—
Except as otherwise provided, the provisions of section
2791 of the Public Health Service Act shall apply for pur-
poses of this title in the same manner as they apply for
purposes of title XXVII of such Act.
(b) SECRETARY.—Except as otherwise provided, the
term ‘‘Secretary’’ means the Secretary of Health and
Human Services, in consultation with the Secretary of
Labor and the term ‘‘appropriate Secretary’’ means the
Secretary of Health and Human Services in relation to
carrying out this title under sections 2706 and 2751 of
227
the Public Health Service Act and the Secretary of Labor
in relation to carrying out this title under section 713 of
the Employee Retirement Income Security Act of 1974.
(c) ADDITIONAL DEFINITIONS.—For purposes of this
title:
(1) ACTIVELY PRACTICING.—The term ‘‘actively
practicing’’ means, with respect to a physician or
other health care professional, such a physician or
professional who provides professional services to in-
dividual patients on average at least two full days
per week.
(2) 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.
228
(3) CLINICAL PEER.—The term ‘‘clinical peer’’
means, with respect to a review or appeal, an ac-
tively practicing physician (allopathic or osteopathic)
or other actively practicing health care professional
who holds a nonrestricted license, and who is appro-
priately credentialed in the same or similar specialty
or subspecialty (as appropriate) as typically handles
the medical condition, procedure, or treatment under
review or appeal and includes a pediatric specialist
where appropriate; except that only a physician
(allopathic or osteopathic) may be a clinical peer
with respect to the review or appeal of treatment
recommended or rendered by a physician.
(4) ENROLLEE.—The term ‘‘enrollee’’ means,
with respect to health insurance coverage offered by
a health insurance issuer, an individual enrolled with
the issuer to receive such coverage.
(5) GROUP HEALTH PLAN.—The term ‘‘group
health plan’’ has the meaning given such term in
section 733(a) of the Employee Retirement Income
Security Act of 1974 and in section 2791(a)(1) of
the Public Health Service Act.
(6) HEALTH CARE PROFESSIONAL.—The term
‘‘health care professional’’ means an individual who
is licensed, accredited, or certified under State law
229
to provide specified health care services and who is
operating within the scope of such licensure, accredi-
tation, or certification.
(7) HEALTH
CARE
PROVIDER.—The term
‘‘health care provider’’ includes a physician or other
health care professional, as well as an institutional
or other facility or agency that provides health care
services and that is licensed, accredited, or certified
to provide health care items and services under ap-
plicable State law.
(8) NETWORK.—The term ‘‘network’’ means,
with respect to a group health plan or health insur-
ance issuer offering health insurance coverage, the
participating health care professionals and providers
through whom the plan or issuer provides health
care items and services to participants, beneficiaries,
or enrollees.
(9) 
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.
230
(10) 
PARTICIPATING.—The 
term 
‘‘partici-
pating’’ means, with respect to a health care pro-
vider that provides health care items and services to
a participant, 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.
(11) PRIOR AUTHORIZATION.—The term ‘‘prior
authorization’’ means the process of obtaining prior
approval from a health insurance issuer or group
health plan for the provision or coverage of medical
services.
SEC. 1152. 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 or other-
wise) except to the extent that such standard or re-
231
quirement prevents the application of a requirement
of this title.
(2) CONTINUED
PREEMPTION
WITH
RESPECT
TO GROUP HEALTH PLANS.—Nothing in this title
shall be construed to affect or modify the provisions
of section 514 of the Employee Retirement Income
Security Act of 1974 with respect to group health
plans.
(b) DEFINITIONS.—For purposes of this section:
(1) STATE
LAW.—The term ‘‘State law’’ in-
cludes all laws, decisions, rules, regulations, or other
State action having the effect of law, of any State.
A law of the United States applicable only to the
District of Columbia shall be treated as a State law
rather than a law of the United States.
(2) STATE.—The term ‘‘State’’ includes a
State, the District of Columbia, Puerto Rico, the
Virgin Islands, Guam, American Samoa, the North-
ern Mariana Islands, any political subdivisions of
such, or any agency or instrumentality of such.
SEC. 1153. EXCLUSIONS.
(a) NO BENEFIT REQUIREMENTS.—Nothing in this
title shall be construed to require a group health plan or
a health insurance issuer offering health insurance cov-
232
erage to provide items and services (including abortions)
that are specifically excluded under the plan or coverage.
(b) EXCLUSION FROM ACCESS TO CARE MANAGED
CARE PROVISIONS FOR FEE-FOR-SERVICE COVERAGE.—
(1) IN GENERAL.—The provisions of sections
1111 through 1117 shall not apply to a group health
plan or health insurance coverage if the only cov-
erage offered under the plan or coverage is fee-for-
service coverage (as defined in paragraph (2)).
(2) FEE-FOR-SERVICE
COVERAGE
DEFINED.—
For purposes of this subsection, the term ‘‘fee-for-
service coverage’’ means coverage under a group
health plan or health insurance coverage that—
(A) reimburses hospitals, health profes-
sionals, and other providers on the basis of a
rate determined by the plan or issuer on a fee-
for-service basis without placing the provider at
financial risk;
(B) does not vary reimbursement for such
a provider based on an agreement to contract
terms and conditions or the utilization of health
care items or services relating to such provider;
(C) does not restrict the selection of pro-
viders among those who are lawfully authorized
to provide the covered services and agree to ac-
233
cept the terms and conditions of payment estab-
lished under the plan or by the issuer; and
(D) for which the plan or issuer does not
require prior authorization before providing cov-
erage for any services.
SEC. 1154. COVERAGE OF LIMITED SCOPE PLANS.
Only for purposes of applying the requirements of
this title under sections 2707 and 2753 of the Public
Health Service Act and section 714 of the Employee Re-
tirement 
Income 
Security 
Act 
of 
1974, 
section
2791(c)(2)(A), and section 733(c)(2)(A) of the Employee
Retirement Income Security Act of 1974 shall be deemed
not to apply.
SEC. 1155. REGULATIONS.
The Secretaries of Health and Human Services and
Labor 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 In-
surance Portability and Accountability Act of 1996. Such
Secretaries may promulgate any interim final rules as the
Secretaries determine are appropriate to carry out this
title.
234
TITLE 
XII—APPLICATION 
OF
QUALITY CARE STANDARDS
TO GROUP HEALTH PLANS
AND 
HEALTH 
INSURANCE
COVERAGE UNDER THE PUB-
LIC HEALTH SERVICE ACT
SEC. 1201. APPLICATION TO GROUP HEALTH PLANS AND
GROUP HEALTH INSURANCE COVERAGE.
(a) IN GENERAL.—Subpart 2 of part A of title
XXVII of the Public Health Service Act is amended by
adding at the end the following new section:
‘‘SEC. 2707. PATIENT PROTECTION STANDARDS.
‘‘(a) IN GENERAL.—Each group health plan shall
comply with patient protection requirements under title XI
of the Bipartisan Consensus Managed Care Improvement
Act of 1999, and each health insurance issuer shall comply
with patient protection requirements under such title with
respect to group health insurance coverage it offers, and
such requirements shall be deemed to be incorporated into
this subsection.
‘‘(b) 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
235
requirement as if such section applied to such issuer and
such issuer were a group health plan.’’.
(b) 
CONFORMING
AMENDMENT.—Section
2721(b)(2)(A) of such Act (42 U.S.C. 300gg–21(b)(2)(A))
is amended by inserting ‘‘(other than section 2707)’’ after
‘‘requirements of such subparts’’.
SEC. 1202. APPLICATION TO INDIVIDUAL HEALTH INSUR-
ANCE COVERAGE.
Part B of title XXVII of the Public Health Service
Act is amended by inserting after section 2752 the fol-
lowing new section:
‘‘SEC. 2753. PATIENT PROTECTION STANDARDS.
‘‘(a) IN GENERAL.—Each health insurance issuer
shall comply with patient protection requirements under
title XI of the Bipartisan Consensus Managed Care Im-
provement Act of 1999 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.’’.
243
construed to invalidate, impair, or supersede
any cause of action by a participant or bene-
ficiary (or the estate of a participant or bene-
ficiary) under State law to recover damages re-
sulting from personal injury or for wrongful
death against any person—
‘‘(i) in connection with the provision
of insurance, administrative services, or
medical services by such person to or for
a group health plan as defined in section
733), or
‘‘(ii) that arises out of the arrange-
ment by such person for the provision of
such insurance, administrative services, or
medical services by other persons.
‘‘(B) LIMITATION
ON
PUNITIVE
DAM-
AGES.—
‘‘(i) IN GENERAL.—No person shall be
liable for any punitive, exemplary, or simi-
lar damages in the case of a cause of ac-
tion brought under subparagraph (A) if—
‘‘(I) it relates to an externally
appealable decision (as defined in sub-
section (a)(2) of section 1103 of the