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certified by the State to engage in the delivery of such
services in the State, is so licensed.
‘‘(f) COMPREHENSIVE STUDY OF COST, QUALITY AND
COORDINATION OF COVERAGE FOR PATIENTS AT THE END
OF LIFE.—
‘‘(1) STUDY BY THE MEDICARE PAYMENT ADVI-
SORY COMMISSION.—The Medicare Payment Advisory
Commission shall conduct a study of the costs and
patterns of care for persons with serious and complex
conditions and the possibilities of improving upon
that care to the degree it is triggered by the current
category of terminally ill as such term is used for
purposes of section 1861(dd) of the Social Security
Act (relating to hospice benefits) or of utilizing care
in other payment settings in Medicare.
‘‘(2) AGENCY FOR HEALTH CARE POLICY AND RE-
SEARCH.—The Agency for Health Care Policy and
Research shall conduct studies of the possible thresh-
olds for major conditions causing serious and complex
illness, their administrative parameters and feasi-
bility, and their impact upon costs and quality.
‘‘(3) HEALTH
CARE
FINANCING
ADMINISTRA-
TION.—The Health Care Financing Administration
shall conduct studies of the merits of applying similar
thresholds in Medicare+Choice programs, including
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adapting risk adjustment methods to account for this
category.
‘‘(4) INITIAL REPORT.—
‘‘(A) IN
GENERAL.—Not later than 12
months after the date of enactment of this sec-
tion, the Medicare Payment Advisory Commis-
sion and the Agency for Health Care Policy and
Research shall each prepare and submit to the
Committee on Health, Education, Labor and
Pensions of the Senate a report concerning the
results of the studies conducted under para-
graphs (1) and (2), respectively.
‘‘(B) COPY
TO
SECRETARY.—Concurrent
with the submission of the reports under sub-
paragraph (A), the Medicare Payment Advisory
Commission and the Agency for health Care Pol-
icy and Research shall transmit a copy of the re-
ports under such subparagraph to the Secretary.
‘‘(5) FINAL REPORT.—
‘‘(A) CONTRACT WITH INSTITUTE OF MEDI-
CINE.—Not later than 1 year after the submis-
sion of the reports under paragraph (4), the Sec-
retary of Health and Human Services shall con-
tract with the Institute of Medicine to conduct a
study of the practices and their effects arising
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from the utilization of the category ‘‘serious and
complex’’ illness.
‘‘(B) REPORT.—Not later than 1 year after
the date of the execution of the contract referred
to in subparagraph (A), the Institute of Medicine
shall prepare and submit to the Committee on
Health, Education, Labor and Pensions of the
Senate a report concerning the study conducted
pursuant to such contract.
‘‘(6) FUNDING.—From funds appropriated to the
Department of Health and Human Services, the Sec-
retary of Health and Human Services shall make
available such funds as the Secretary determines is
necessary to carry out this subsection.
‘‘SEC. 727. PROTECTION OF PATIENT-PROVIDER COMMU-
NICATIONS.
‘‘(a) IN GENERAL.—Subject to subsection (b), a group
health plan (other than a fully insured group health plan
and in relation to a participant or beneficiary) shall not
prohibit or otherwise restrict a health care professional from
advising such a participant or beneficiary who is a patient
of the professional about the health status of the participant
or beneficiary or medical care or treatment for the condition
or disease of the participant or beneficiary, regardless of
whether coverage for such care or treatment are provided
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under the contract, if the professional is acting within the
lawful scope of practice.
‘‘(b) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as requiring a group health plan
(other than a fully insured group health plan) to provide
specific benefits under the terms of such plan.
‘‘SEC. 728. PATIENT’S RIGHT TO PRESCRIPTION DRUGS.
‘‘To the extent that a group health plan (other than
a fully insured group health plan) provides coverage for
benefits with respect to prescription drugs, and limits such
coverage to drugs included in a formulary, the plan shall—
‘‘(1) ensure the participation of physicians and
pharmacists in developing and reviewing such for-
mulary; and
‘‘(2) in accordance with the applicable quality
assurance and utilization review standards of the
plan, provide for exceptions from the formulary limi-
tation when a non-formulary alternative is medically
necessary and appropriate.
‘‘SEC. 729. SELF-PAYMENT FOR BEHAVIORAL HEALTH CARE
SERVICES.
‘‘(a) IN GENERAL.—A group health plan (other than
a fully insured group health plan) may not—
‘‘(1) prohibit or otherwise discourage a partici-
pant or beneficiary from self-paying for behavioral
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health care services once the plan has denied coverage
for such services; or
‘‘(2) terminate a health care provider because
such provider permits participants or beneficiaries to
self-pay for behavioral health care services—
‘‘(A) that are not otherwise covered under
the plan; or
‘‘(B) for which the group health plan pro-
vides limited coverage, to the extent that the
group health plan denies coverage of the services.
‘‘(b) RULE OF CONSTRUCTION.—Nothing in subsection
(a)(2)(B) shall be construed as prohibiting a group health
plan from terminating a contract with a health care pro-
vider for failure to meet applicable quality standards or
for fraud.
‘‘SEC. 730. COVERAGE FOR INDIVIDUALS PARTICIPATING IN
APPROVED CANCER CLINICAL TRIALS.
‘‘(a) COVERAGE.—
‘‘(1) IN GENERAL.—If a group health plan (other
than a fully insured group health plan) provides cov-
erage to a qualified individual (as defined in sub-
section (b)), the plan—
‘‘(A) may not deny the individual partici-
pation in the clinical trial referred to in sub-
section (b)(2);
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‘‘(B) subject to subsections (b), (c), and (d)
may not deny (or limit or impose additional
conditions on) the coverage of routine patient
costs for items and services furnished in connec-
tion with participation in the trial; and
‘‘(C) may not discriminate against the in-
dividual on the basis of the participant’s or
beneficiaries participation 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 con-
ducted 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 from requiring that a
qualified individual participate in the trial through
such a participating provider if the provider will ac-
cept the individual as a participant in the trial.
‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For purposes
of subsection (a), the term ‘‘qualified individual’’ means an
individual who is a participant or beneficiary in a group
health plan and who meets the following conditions:
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‘‘(iii) previous and on-going studies re-
lating to patient care costs associated with
participation in clinical trials.
‘‘(C) PUBLICATION
OF
NOTICE.—In car-
rying out the rulemaking process under this
paragraph, the Secretary, after consultation with
organizations 
representing 
cancer 
patients,
health care practitioners, medical researchers,
employers, group health plans, manufacturers of
drugs, biologics and medical devices, medical
economists, hospitals, and other interested par-
ties, shall publish notice provided for under sec-
tion 564(a) of title 5, United States Code, by not
later than 45 days after the date of the enact-
ment of this section.
‘‘(D) TARGET DATE FOR PUBLICATION OF
RULE.—As part of the notice under subpara-
graph (C), and for purposes of this paragraph,
the ‘target date for publication’ (referred to in
section 564(a)(5) of such title 5) shall be June
30, 2000.
‘‘(E) ABBREVIATED
PERIOD
FOR
SUBMIS-
SION OF COMMENTS.—In applying section 564(c)
of such title 5 under this paragraph, ‘15 days’
shall be substituted for ‘30 days’.
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‘‘(F) APPOINTMENT OF NEGOTIATED RULE-
MAKING
COMMITTEE
AND
FACILITATOR.—The
Secretary shall provide for—
‘‘(i) the appointment of a negotiated
rulemaking committee under section 565(a)
of such title 5 by not later than 30 days
after the end of the comment period pro-
vided for under section 564(c) of such title
5 (as shortened under subparagraph (E)),
and
‘‘(ii) the nomination of a facilitator
under section 566(c) of such title 5 by not
later than 10 days after the date of appoint-
ment of the committee.
‘‘(G) PRELIMINARY COMMITTEE REPORT.—
The negotiated rulemaking committee appointed
under subparagraph (F) shall report to the Sec-
retary, by not later than March 29, 2000, re-
garding the committee’s progress on achieving a
consensus with regard to the rulemaking pro-
ceeding and whether such consensus is likely to
occur before 1 month before the target date for
publication of the rule. If the committee reports
that the committee has failed to make significant
progress towards such consensus or is unlikely to
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reach such consensus by the target date, the Sec-
retary may terminate such process and provide
for the publication of a rule under this para-
graph through such other methods as the Sec-
retary may provide.
‘‘(H) FINAL
COMMITTEE
REPORT.—If the
committee is not terminated under subparagraph
(G), the rulemaking committee shall submit a re-
port containing a proposed rule by not later
than 1 month before the target date of publica-
tion.
‘‘(I) FINAL
EFFECT.—The Secretary shall
publish a rule under this paragraph in the Fed-
eral Register by not later than the target date of
publication.
‘‘(J) PUBLICATION OF RULE AFTER PUBLIC
COMMENT.—The Secretary shall provide for con-
sideration of such comments and republication of
such rule by not later than 1 year after the tar-
get date of publication.
‘‘(K) EFFECTIVE DATE.—The provisions of
this paragraph shall apply to group health plans
(other than a fully insured group health plan)
for plan years beginning on or after January 1,
2001.
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‘‘(3) 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 would
normally pay for comparable services under sub-
paragraph (A).
‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—
‘‘(1) IN GENERAL.—In this section, the term ‘ap-
proved clinical trial’ means a cancer clinical research
study or cancer clinical investigation approved and
funded (which may include funding through in-kind
contributions) 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 con-
ditions described in this paragraph, for a study or in-
vestigation conducted by a Department, are that the
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study or investigation has been reviewed and ap-
proved through a system of peer review that the Sec-
retary 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 coverage with respect to clinical
trials.
‘‘(f) PLAN SATISFACTION OF CERTAIN REQUIREMENTS;
RESPONSIBILITIES OF FIDUCIARIES.—
‘‘(1) IN GENERAL.—For purposes of this section,
insofar as a group health plan provides benefits in the
form of health insurance coverage through a health in-
surance issuer, the plan shall be treated as meeting
the requirements of this section with respect to such
benefits and not be considered as failing to meet such
requirements because of a failure of the issuer to meet
such requirements so long as the plan sponsor or its
representatives did not cause such failure by the
issuer.
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‘‘(2) CONSTRUCTION.—Nothing in this section
shall be construed to affect or modify the responsibil-
ities of the fiduciaries of a group health plan under
part 4 of subtitle B.
‘‘(g) STUDY AND REPORT.—
‘‘(1) STUDY.—The Secretary shall study the im-
pact on group health plans for covering routine pa-
tient care costs for individuals who are entitled to
benefits under this section and who are enrolled in an
approved cancer clinical trial program.
‘‘(2) REPORT
TO
CONGRESS.—Not later than
January 1, 2005, the Secretary shall submit a report
to Congress that contains an assessment of—
‘‘(A) any incremental cost to group health
plans resulting from the provisions of this sec-
tion;
‘‘(B) a projection of expenditures to such
plans resulting from this section; and
‘‘(C) any impact on premiums resulting
from this section.
‘‘SEC. 730A. PROHIBITING DISCRIMINATION AGAINST PRO-
VIDERS.
‘‘(a) IN GENERAL.—A group health plan (other than
a fully insured group health plan) shall not discriminate
with respect to participation or indemnification as to any
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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 certification. This subsection
shall not be construed as requiring the coverage under a
plan of particular benefits or services or to prohibit a plan
from including providers only to the extent necessary to
meet the needs of the plan’s participants and beneficiaries
or from establishing any measure designed to maintain
quality and control costs consistent with the responsibilities
of the plan.
‘‘(b) NO REQUIREMENT
FOR
ANY WILLING PRO-
VIDER.—Nothing in this section shall be construed as re-
quiring a group health plan that offers network coverage
to include for participation every willing provider or health
professional who meets the terms and conditions of the plan.
‘‘SEC. 730B. GENERALLY APPLICABLE PROVISION.
‘‘In the case of a group health plan that provides bene-
fits under 2 or more coverage options, the requirements of
this subpart shall apply separately with respect to each cov-
erage option.’’.
(b) RULE WITH RESPECT TO CERTAIN PLANS.—
(1) IN
GENERAL.—Notwithstanding any other
provision of law, health insurance issuers may offer,
and eligible individuals may purchase, high deduct-
ible health plans described in section 220(c)(2)(A) of
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the Internal Revenue Code of 1986. Effective for the
4-year period beginning on the date of the enactment
of this Act, such health plans shall not be required to
provide payment for any health care items or services
that are exempt from the plan’s deductible.
(2) EXISTING STATE LAWS.—A State law relat-
ing to payment for health care items and services in
effect on the date of enactment of this Act that is pre-
empted under paragraph (1), shall not apply to high
deductible health plans after the expiration of the 4-
year period described in such paragraph unless the
State reenacts such law after such period.
(c) DEFINITION.—Section 733(a) of the Employee Re-
tirement Income Security Act of 1974 (42 U.S.C. 1191(a))
is amended by adding at the end the following:
‘‘(3) FULLY INSURED GROUP HEALTH PLAN.—
The term ‘fully insured group health plan’ means a
group health plan where benefits under the plan are
provided pursuant to the terms of an arrangement be-
tween a group health plan and a health insurance
issuer and are guaranteed by the health insurance
issuer under a contract or policy of insurance.’’.
(d) CONFORMING AMENDMENT.—The table of contents
in section 1 of such Act is amended—
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(1) in the item relating to subpart C, by striking
‘‘Subpart C’’ and inserting ‘‘Subpart D’’; and
(2) by adding at the end of the items relating to
subpart B of part 7 of subtitle B of title I of such Act
the following new items:
‘‘SUBPART C—PATIENT RIGHT TO MEDICAL ADVICE AND CARE
‘‘Sec. 721. Patient access to emergency medical care.
‘‘Sec. 722. Offering of choice of coverage options.
‘‘Sec. 723. Patient access to obstetric and gynecological care.
‘‘Sec. 724. Patient access to pediatric care.
‘‘Sec. 725. Timely access to specialists.
‘‘Sec. 726. Continuity of care.
‘‘Sec. 727. Protection of patient-provider communications.
‘‘Sec. 728. Patient’s right to prescription drugs.
‘‘Sec. 729. Self-payment for behavioral health care services.
‘‘Sec. 730. Coverage for individuals participating in approved cancer clinical
trials.
‘‘Sec. 730A. Prohibiting discrimination against providers.
‘‘Sec. 730B. Generally applicable provision.’’.
SEC. 102. CONFORMING AMENDMENT TO THE INTERNAL
REVENUE CODE OF 1986.
(a) IN GENERAL.—Chapter 100 of the Internal Rev-
enue Code of 1986 is amended—
(1) by redesignating subchapter C as subchapter
D; and
(2) by inserting after subchapter B the following:
‘‘Subchapter C—Patient Right to Medical
Advice and Care
‘‘Sec. 9821. Patient access to emergency medical care.
‘‘Sec. 9822. Offering of choice of coverage options.
‘‘Sec. 9823. Patient access to obstetric and gynecological care.
‘‘Sec. 9824. Patient access to pediatric care.
‘‘Sec. 9825. Timely access to specialists.
‘‘Sec. 9826. Continuity of care.
‘‘Sec. 9827. Protection of patient-provider communications.
‘‘Sec. 9828. Patient’s right to prescription drugs.
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‘‘Sec. 9829. Self-payment for behavioral health care services.
‘‘Sec. 9830. Coverage for individuals participating in approved cancer clinical
trials.
‘‘Sec. 9830A. Prohibiting discrimination against providers.
‘‘Sec. 9830B. Generally applicable provision.
‘‘SEC. 9821. PATIENT ACCESS TO EMERGENCY MEDICAL
CARE.
‘‘(a) COVERAGE OF EMERGENCY CARE.—
‘‘(1) IN GENERAL.—To the extent that the group
health plan (other than a fully insured group health
plan) provides coverage for benefits consisting of
emergency medical care (as defined in subsection (c))
or emergency ambulance services, except for items or
services specifically excluded—
‘‘(A) the plan shall provide coverage for
benefits, without requiring preauthorization, for
emergency medical screening examinations or
emergency ambulance services, to the extent that
a prudent layperson, who possesses an average
knowledge of health and medicine, would deter-
mine such examinations or emergency ambu-
lance services to be necessary to determine wheth-
er emergency medical care (as so defined) is nec-
essary; and
‘‘(B) the plan shall provide coverage for
benefits, without requiring preauthorization, for
additional emergency medical care to stabilize
an emergency medical condition following an
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emergency medical screening examination (if de-
termined necessary under subparagraph (A)),
pursuant to the definition of stabilize under sec-
tion 1867(e)(3) of the Social Security Act (42
U.S.C. 1395dd(e)(3)).
‘‘(2) REIMBURSEMENT FOR CARE TO MAINTAIN
MEDICAL STABILITY.—
‘‘(A) IN GENERAL.—In the case of services
provided to a participant or beneficiary by a
nonparticipating provider in order to maintain
the medical stability of the participant or bene-
ficiary, the group health plan involved shall pro-
vide for reimbursement with respect to such serv-
ices if—
‘‘(i) coverage for services of the type
furnished is available under the group
health plan;
‘‘(ii) the services were provided for care
related to an emergency medical condition
and in an emergency department in order
to maintain the medical stability of the
participant or beneficiary; and
‘‘(iii) the nonparticipating provider
contacted the plan regarding approval for
such services.
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‘‘(B) FAILURE TO RESPOND.—If a group
health plan fails to respond within 1 hours of
being contacted in accordance with subpara-
graph (A)(iii), then the plan shall be liable for
the cost of services provided by the nonpartici-
pating provider in order to maintain the sta-
bility of the participant or beneficiary.
‘‘(C) LIMITATION.—The liability of a group
health plan to provide reimbursement under sub-
paragraph (A) shall terminate when the plan
has contacted the nonparticipating provider to
arrange for discharge or transfer.
‘‘(D) LIABILITY OF PARTICIPANT.—A par-
ticipant or beneficiary shall not be liable for the
costs of services to which subparagraph (A) in an
amount that exceeds the amount of liability that
would be incurred if the services were provided
by a participating health care provider with
prior authorization by the plan.
‘‘(b) IN-NETWORK UNIFORM COSTS-SHARING
AND
OUT-OF-NETWORK CARE.—
‘‘(1) IN-NETWORK
UNIFORM
COST-SHARING.—
Nothing in this section shall be construed as pre-
venting a group health plan (other than a fully in-
sured group health plan) from imposing any form of
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cost-sharing applicable to any participant or bene-
ficiary 
(including 
coinsurance, 
copayments,
deductibles, and any other charges) in relation to cov-
erage for benefits described in subsection (a), if such
form of cost-sharing is uniformly applied under such
plan, with respect to similarly situated participants
and beneficiaries, to all benefits consisting of emer-
gency medical care (as defined in subsection (c)) pro-
vided to such similarly situated participants and
beneficiaries under the plan, and such cost-sharing is
disclosed in accordance with section 9814.
‘‘(2) OUT-OF-NETWORK CARE.—If a group health
plan (other than a fully insured group health plan)
provides any benefits with respect to emergency med-
ical care (as defined in subsection (c)), the plan shall
cover emergency medical care under the plan in a
manner so that, if such care is provided to a partici-
pant or beneficiary by a nonparticipating health care
provider, the participant or beneficiary is not liable
for amounts that exceed any form of cost-sharing (in-
cluding coinsurance, copayments, deductibles, and
any other charges) that would be incurred if the serv-
ices were provided by a participating provider.
‘‘(c) DEFINITION OF EMERGENCY MEDICAL CARE.—In
this section:
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‘‘(1) IN GENERAL.—The term ‘emergency medical
care’ means, with respect to a participant or bene-
ficiary under a group health plan (other than a fully
insured group health plan), covered inpatient and
outpatient services that—
‘‘(A) are furnished by any provider, includ-
ing a nonparticipating provider, that is quali-
fied to furnish such services; and
‘‘(B) are needed to evaluate or stabilize (as
such term is defined in section 1867(e)(3) of the
Social Security Act (42 U.S.C. 1395dd)(e)(3))
an emergency medical condition (as defined in
paragraph (2)).
‘‘(2) EMERGENCY
MEDICAL
CONDITION.—The
term ‘emergency medical condition’ means a medical
condition manifesting itself by acute symptoms of suf-
ficient severity (including severe pain) such that a
prudent layperson, who possesses an average knowl-
edge of health and medicine, could reasonably expect
the absence of immediate medical attention to result
in—
‘‘(A) placing the health of the participant or
beneficiary (or, with respect to a pregnant
woman, the health of the woman or her unborn
child) in serious jeopardy,
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‘‘(B) serious impairment to bodily func-
tions, or
‘‘(C) serious dysfunction of any bodily
organ or part.
‘‘SEC. 9822. OFFERING OF CHOICE OF COVERAGE OPTIONS.
‘‘(a) REQUIREMENT.—
‘‘(1) OFFERING OF POINT-OF-SERVICE COVERAGE
OPTION.—Except as provided in paragraph (2), if a
group health plan (other than a fully insured group
health plan) provides coverage for benefits only
through a defined set of participating health care pro-
fessionals, the plan shall offer the participant the op-
tion 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 and at such other times as
the plan offers the participant a choice of coverage op-
tions.
‘‘(2) EXCEPTION IN CASE OF LACK OF AVAIL-
ABILITY.—Paragraph (1) shall not apply with respect
to a group health plan (other than a fully insured
group health plan) if care relating to the point-of-
service coverage would not be available and accessible
to the participant with reasonable promptness (con-
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sistent with section 1301(b)(4) of the Public Health
Service Act (42 U.S.C. 300e(b)(4))).
‘‘(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 (other
than a fully insured group health plan), coverage of such
benefits when provided by a nonparticipating health care
professional.
‘‘(c) SMALL EMPLOYER EXEMPTION.—
‘‘(1) IN GENERAL.—This section shall not apply
to any group health plan (other than a fully insured
group health plan) of a small employer.
‘‘(2) SMALL EMPLOYER.—For purposes of para-
graph (1), the term ‘small employer’ means, in con-
nection with a group health plan (other than a fully
insured group health plan) with respect to a calendar
year and a plan year, an employer who employed an
average of at least 2 but not more than 50 employees
on business days during the preceding calendar year
and who employs at least 2 employees on the first day
of the plan year. For purposes of this paragraph, the
provisions 
of 
subparagraph 
(C) 
of 
section
4980D(d)(2) shall apply in determining employer
size.
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‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed—
‘‘(1) as requiring coverage for benefits for a par-
ticular type of health care professional;
‘‘(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 options;
‘‘(3) as preventing a group health plan (other
than a fully insured group health plan) from impos-
ing higher premiums or cost-sharing on a participant
for the exercise of a point-of-service coverage option;
or
‘‘(4) to require that a group health plan (other
than a fully insured group health plan) include cov-
erage of health care professionals that the plan ex-
cludes because of fraud, quality of care, or other simi-
lar reasons with respect to such professionals.
‘‘SEC. 9823. PATIENT ACCESS TO OBSTETRIC AND GYNECO-
LOGICAL CARE.
‘‘(a) GENERAL RIGHTS.—
‘‘(1) WAIVER
OF
PLAN
REFERRAL
REQUIRE-
MENT.—If a group health plan described in subsection
(b) requires a referral to obtain coverage for specialty
care, the plan shall waive the referral requirement in
the case of a female participant or beneficiary who
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seeks coverage for obstetrical care and related follow-
up obstetrical care or routine gynecological care (such
as preventive gynecological care).
‘‘(2) RELATED ROUTINE CARE.—With respect to
a participant or beneficiary described in paragraph
(1), a group health plan described in subsection (b)
shall treat the ordering of other routine care that is
related to routine gynecologic care, by a physician
who specializes in obstetrics and gynecology as the
authorization of the primary care provider for such
other care.
‘‘(b) APPLICATION OF SECTION.—A group health plan
described in this subsection is a group health plan (other
than a fully insured group health plan), that—
‘‘(1) provides coverage for obstetric care (such as
pregnancy-related services) or routine gynecologic
care (such as preventive women’s health examina-
tions); and
‘‘(2) requires the designation by a participant or
beneficiary of a participating primary care provider
who is not a physician who specializes in obstetrics
or gynecology.
‘‘(c) RULES OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed—
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‘‘(1) as waiving any coverage requirement relat-
ing to medical necessity or appropriateness with re-
spect to the coverage of obstetric or gynecologic care
described in subsection (a);
‘‘(2) to preclude the plan from requiring that the
physician who specializes in obstetrics or gynecology
notify the designated primary care provider or the
plan of treatment decisions;
‘‘(3) to preclude a group health plan from allow-
ing health care professionals other than physicians to
provide routine obstetric or routine gynecologic care;
or
‘‘(4) to preclude a group health plan from per-
mitting a physician who specializes in obstetrics and
gynecology from being a primary care provider under
the plan.
‘‘SEC. 9824. PATIENT ACCESS TO PEDIATRIC CARE.
‘‘(a) IN GENERAL.—In the case of a group health plan
(other than a fully insured group health plan) that provides
coverage for routine pediatric care and that requires the
designation by a participant or beneficiary of a partici-
pating primary care provider, if the designated primary
care provider is not a physician who specializes in
pediatrics—
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that participants and beneficiaries have timely, in
accordance with the medical exigencies of the case, ac-
cess to primary and specialty health care profes-
sionals who are appropriate to the condition of the
participant or beneficiary, when such care is covered
under the plan. Such access may be provided through
contractual arrangements with specialized providers
outside of the network of the plan.
‘‘(2) RULE
OF
CONSTRUCTION.—Nothing in
paragraph (1) shall be construed—
‘‘(A) to require the coverage under a group
health plan of particular benefits or services or
to prohibit a plan from including providers only
to the extent necessary to meet the needs of the
plan’s participants or beneficiaries or from es-
tablishing any measure designed to maintain
quality and control costs consistent with the re-
sponsibilities of the plan; or
‘‘(B) to override any State licensure or
scope-of-practice law.
‘‘(b) TREATMENT PLANS.—
‘‘(1) IN GENERAL.—Nothing in this section shall
be construed to prohibit a group health plan (other
than a fully insured group health plan) from requir-
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ing that specialty care be provided pursuant to a
treatment plan so long as the treatment plan is—
‘‘(A) developed by the specialist, in con-
sultation with the case manager or primary care
provider, and the participant or beneficiary;
‘‘(B) approved by the plan in a timely
manner in accordance with the medical exigen-
cies of the case; and
‘‘(C) in accordance with the applicable
quality assurance and utilization review stand-
ards of the plan.
‘‘(2) NOTIFICATION.—Nothing in paragraph (1)
shall be construed as prohibiting a plan from requir-
ing the specialist to provide the case manager or pri-
mary care provider with regular updates on the spe-
cialty care provided, as well as all other necessary
medical information.
‘‘(c) REFERRALS.—Nothing in this section shall be
construed to prohibit a plan from requiring an authoriza-
tion by the case manager or primary care provider of the
participant or beneficiary in order to obtain coverage for
specialty services so long as such authorization is for an
adequate number of referrals.
‘‘(d) SPECIALTY CARE DEFINED.—For purposes of this
subsection, the term ‘specialty care’ means, with respect to
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a condition, care and treatment provided by a health care
practitioner, facility, or center (such as a center of excel-
lence) that has adequate expertise (including age-appro-
priate expertise) through appropriate training and experi-
ence.
‘‘SEC. 9826. CONTINUITY OF CARE.
‘‘(a) IN GENERAL.—
‘‘(1) TERMINATION OF PROVIDER.—If a contract
between a group health plan (other than a fully in-
sured group health plan) and a health care provider
is terminated (as defined in paragraph (2)), or bene-
fits or coverage provided by a health care provider are
terminated because of a change in the terms of pro-
vider participation in such group health plan, and
an individual who is a participant or beneficiary in
the plan is undergoing a course of treatment from the
provider at the time of such termination, the plan
shall—
‘‘(A) notify the individual on a timely basis
of such termination;
‘‘(B) provide the individual with an oppor-
tunity to notify the plan of a need for transi-
tional care; and
‘‘(C) in the case of termination described in
paragraph (2), (3), or (4) of subsection (b), and
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subject to subsection (c), permit the individual to
continue or be covered with respect to the course
of treatment with the provider’s consent during
a transitional period (as provided under sub-
section (b)).
‘‘(2) TERMINATED.—In this section, the term
‘terminated’ includes, with respect to a contract, the
expiration or nonrenewal of the contract by the group
health plan, but does not include a termination of the
contract by the plan for failure to meet applicable
quality standards or for fraud.
‘‘(3) CONTRACTS.—For purposes of this section,
the term ‘contract between a group health plan (other
than a fully insured group health plan) and a health
care provider’ shall include a contract between such
a plan and an organized network of providers.
‘‘(b) TRANSITIONAL PERIOD.—
‘‘(1) GENERAL
RULE.—Except as provided in
paragraph (3), the transitional period under this sub-
section shall permit the participant or beneficiary to
extend the coverage involved for up to 90 days from
the date of the notice described in subsection (a)(1)(A)
of the provider’s termination.
‘‘(2) INSTITUTIONAL
CARE.—Subject to para-
graph (1), the transitional period under this sub-
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section for institutional or inpatient care from a pro-
vider shall extend until the discharge or termination
of the period of institutionalization and also shall in-
clude institutional care provided within a reasonable
time of the date of termination of the provider status
if the care was scheduled before the date of the an-
nouncement 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 other-
wise scheduled to have such care.
‘‘(3) PREGNANCY.—Notwithstanding paragraph
(1), if—
‘‘(A) a participant or beneficiary has en-
tered the second trimester of pregnancy at the
time of a provider’s termination of participa-
tion; and
‘‘(B) the provider was treating the preg-
nancy before the 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.—Notwithstanding
paragraph (1), if—
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‘‘(A) a participant or beneficiary was deter-
mined to be terminally ill (as determined under
section 1861(dd)(3)(A) of the Social Security
Act) prior to a provider’s termination of partici-
pation; and
‘‘(B) the provider was treating the terminal
illness before the date of termination;
the transitional period under this subsection shall be
for care directly related to the treatment of the ter-
minal illness and shall extend for the remainder of
the individual’s life for such care.
‘‘(c) PERMISSIBLE TERMS AND CONDITIONS.—A group
health plan (other than a fully insured group health plan)
may condition coverage of continued treatment by a pro-
vider under subsection (a)(1)(C) upon the provider agreeing
to the following terms and conditions:
‘‘(1) The provider agrees to accept reimburse-
ment from the plan and individual involved (with re-
spect to cost-sharing) at the rates applicable prior to
the start of the transitional period as payment in full
(or at the rates applicable under the replacement plan
after the date of the termination of the contract with
the group health plan) and not to impose cost-sharing
with respect to the individual in an amount that
would exceed the cost-sharing that could have been
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imposed if the contract referred to in subsection (a)(1)
had not been terminated.
‘‘(2) The provider agrees to adhere to the quality
assurance standards of the plan responsible for pay-
ment under paragraph (1) and to provide to such
plan necessary medical information related to the
care provided.
‘‘(3) The provider agrees otherwise to adhere to
such plan’s policies and procedures, including proce-
dures regarding referrals and obtaining prior author-
ization and providing services pursuant to a treat-
ment plan (if any) approved by the plan.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to require the coverage of benefits
which would not have been covered if the provider involved
remained a participating provider.
‘‘(e) DEFINITION.—In this section, the term ‘health
care provider’ or ‘provider’ means—
‘‘(1) any individual who is engaged in the deliv-
ery of health care services in a State and who is re-
quired by State law or regulation to be licensed or
certified by the State to engage in the delivery of such
services in the State; and
‘‘(2) any entity that is engaged in the delivery
of health care services in a State and that, if it is re-
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quired by State law or regulation to be licensed or
certified by the State to engage in the delivery of such
services in the State, is so licensed.
‘‘(f) COMPREHENSIVE STUDY OF COST, QUALITY AND
COORDINATION OF COVERAGE FOR PATIENTS AT THE END
OF LIFE.—
‘‘(1) STUDY BY THE MEDICARE PAYMENT ADVI-
SORY COMMISSION.—The Medicare Payment Advisory
Commission shall conduct a study of the costs and
patterns of care for persons with serious and complex
conditions and the possibilities of improving upon
that care to the degree it is triggered by the current
category of terminally ill as such term is used for
purposes of section 1861(dd) of the Social Security
Act (relating to hospice benefits) or of utilizing care
in other payment settings in Medicare.
‘‘(2) AGENCY FOR HEALTH CARE POLICY AND RE-
SEARCH.—The Agency for Health Care Policy and
Research shall conduct studies of the possible thresh-
olds for major conditions causing serious and complex
illness, their administrative parameters and feasi-
bility, and their impact upon costs and quality.
‘‘(3) HEALTH
CARE
FINANCING
ADMINISTRA-
TION.—The Health Care Financing Administration
shall conduct studies of the merits of applying similar
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thresholds in Medicare+Choice programs, including
adapting risk adjustment methods to account for this
category.
‘‘(4) INITIAL REPORT.—
‘‘(A) IN
GENERAL.—Not later than 12
months after the date of enactment of this sec-
tion, the Medicare Payment Advisory Commis-
sion and the Agency for Health Care Policy and
Research shall each prepare and submit to the
Committee on Health, Education, Labor and
Pensions of the Senate a report concerning the
results of the studies conducted under para-
graphs (1) and (2), respectively.
‘‘(B) COPY
TO
SECRETARY.—Concurrent
with the submission of the reports under sub-
paragraph (A), the Medicare Payment Advisory
Commission and the Agency for health Care Pol-
icy and Research shall transmit a copy of the re-
ports under such subparagraph to the Secretary.
‘‘(5) FINAL REPORT.—
‘‘(A) CONTRACT WITH INSTITUTE OF MEDI-
CINE.—Not later than 1 year after the submis-
sion of the reports under paragraph (4), the Sec-
retary of Health and Human Services shall con-
tract with the Institute of Medicine to conduct a
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study of the practices and their effects arising
from the utilization of the category ‘‘serious and
complex’’ illness.
‘‘(B) REPORT.—Not later than 1 year after
the date of the execution of the contract referred
to in subparagraph (A), the Institute of Medicine
shall prepare and submit to the Committee on
Health, Education, Labor and Pensions of the
Senate a report concerning the study conducted
pursuant to such contract.
‘‘(6) FUNDING.—From funds appropriated to the
Department of Health and Human Services, the Sec-
retary of Health and Human Services shall make
available such funds as the Secretary determines is
necessary to carry out this subsection.
‘‘SEC. 9827. PROTECTION OF PATIENT-PROVIDER COMMU-
NICATIONS.
‘‘(a) IN GENERAL.—Subject to subsection (b), a group
health plan (other than a fully insured group health plan
and in relation to a participant or beneficiary) shall not
prohibit or otherwise restrict a health care professional from
advising such a participant or beneficiary who is a patient
of the professional about the health status of the participant
or beneficiary or medical care or treatment for the condition
or disease of the participant or beneficiary, regardless of
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whether coverage for such care or treatment are provided
under the contract, if the professional is acting within the
lawful scope of practice.
‘‘(b) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as requiring a group health plan
(other than a fully insured group health plan) to provide
specific benefits under the terms of such plan.
‘‘SEC. 9828. PATIENT’S RIGHT TO PRESCRIPTION DRUGS.
‘‘To the extent that a group health plan (other than
a fully insured group health plan) provides coverage for
benefits with respect to prescription drugs, and limits such
coverage to drugs included in a formulary, the plan shall—
‘‘(1) ensure the participation of physicians and
pharmacists in developing and reviewing such for-
mulary; and
‘‘(2) in accordance with the applicable quality
assurance and utilization review standards of the
plan, provide for exceptions from the formulary limi-
tation when a non-formulary alternative is medically
necessary and appropriate.
‘‘SEC. 9829. SELF-PAYMENT FOR BEHAVIORAL HEALTH CARE
SERVICES.
‘‘(a) IN GENERAL.—A group health plan (other than
a fully insured group health plan) may not—
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‘‘(1) prohibit or otherwise discourage a partici-
pant or beneficiary from self-paying for behavioral
health care services once the plan has denied coverage
for such services; or
‘‘(2) terminate a health care provider because
such provider permits participants or beneficiaries to
self-pay for behavioral health care services—
‘‘(A) that are not otherwise covered under
the plan; or
‘‘(B) for which the group health plan pro-
vides limited coverage, to the extent that the
group health plan denies coverage of the services.
‘‘(b) RULE OF CONSTRUCTION.—Nothing in subsection
(a)(2)(B) shall be construed as prohibiting a group health
plan from terminating a contract with a health care pro-
vider for failure to meet applicable quality standards or
for fraud.
‘‘SEC. 9830. COVERAGE FOR INDIVIDUALS PARTICIPATING
IN APPROVED CANCER CLINICAL TRIALS.
‘‘(a) COVERAGE.—
‘‘(1) IN GENERAL.—If a group health plan (other
than a fully insured group health plan) provides cov-
erage to a qualified individual (as defined in sub-
section (b)), the plan—
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‘‘(A) may not deny the individual partici-
pation in the clinical trial referred to in sub-
section (b)(2);
‘‘(B) subject to subsections (b), (c), and (d)
may not deny (or limit or impose additional
conditions on) the coverage of routine patient
costs for items and services furnished in connec-
tion with participation in the trial; and
‘‘(C) may not discriminate against the in-
dividual on the basis of the participant’s or
beneficiaries participation 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 con-
ducted 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 from requiring that a
qualified individual participate in the trial through
such a participating provider if the provider will ac-
cept the individual as a participant in the trial.
‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For purposes
of subsection (a), the term ‘‘qualified individual’’ means an
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individual who is a participant or beneficiary in a group
health plan and who meets the following conditions:
‘‘(1)(A) The individual has been diagnosed with
cancer for which no standard treatment is effective.
‘‘(B) The individual is eligible to participate in
an approved clinical trial according to the trial pro-
tocol with respect to treatment of such illness.
‘‘(C) The individual’s participation in the trial
offers meaningful potential for significant clinical
benefit for the individual.
‘‘(2) Either—
‘‘(A) the referring physician is a partici-
pating health care professional and has con-
cluded that the individual’s participation in
such trial would be appropriate based upon the
individual meeting the conditions described in
paragraph (1); or
‘‘(B) the participant or beneficiary provides
medical and scientific information establishing
that the individual’s participation in such trial
would be appropriate based upon the individual
meeting the conditions described in paragraph
(1).
‘‘(c) PAYMENT.—
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‘‘(1) IN GENERAL.—Under this section a group
health plan (other than a fully insured group health
plan) 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 reason-
ably expected to be paid for by the sponsors of an ap-
proved clinical trial.
‘‘(2) STANDARDS
FOR
DETERMINING
ROUTINE
PATIENT
COSTS
ASSOCIATED
WITH
CLINICAL
TRIAL
PARTICIPATION.—
‘‘(A) IN GENERAL.—The Secretary shall es-
tablish, on an expedited basis and using a nego-
tiated rulemaking process under subchapter III
of chapter 5 of title 5, United States Code, stand-
ards relating to the coverage of routine patient
costs for individuals participating in clinical
trials that group health plans must meet under
this section.
‘‘(B) FACTORS.—In establishing routine pa-
tient cost standards under subparagraph (A), the
Secretary shall consult with interested parties
and take into account —
‘‘(i) quality of patient care;
‘‘(ii) routine patient care costs versus
costs associated with the conduct of clinical
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trials, including unanticipated patient care
costs as a result of participation in clinical
trials; and
‘‘(iii) previous and on-going studies re-
lating to patient care costs associated with
participation in clinical trials.
‘‘(C) PUBLICATION
OF
NOTICE.—In car-
rying out the rulemaking process under this
paragraph, the Secretary, after consultation with
organizations 
representing 
cancer 
patients,
health care practitioners, medical researchers,
employers, group health plans, manufacturers of
drugs, biologics and medical devices, medical
economists, hospitals, and other interested par-
ties, shall publish notice provided for under sec-
tion 564(a) of title 5, United States Code, by not
later than 45 days after the date of the enact-
ment of this section.
‘‘(D) TARGET DATE FOR PUBLICATION OF
RULE.—As part of the notice under subpara-
graph (C), and for purposes of this paragraph,
the ‘target date for publication’ (referred to in
section 564(a)(5) of such title 5) shall be June
30, 2000.
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‘‘(E) ABBREVIATED
PERIOD
FOR
SUBMIS-
SION OF COMMENTS.—In applying section 564(c)
of such title 5 under this paragraph, ‘15 days’
shall be substituted for ‘30 days’.
‘‘(F) APPOINTMENT OF NEGOTIATED RULE-
MAKING
COMMITTEE
AND
FACILITATOR.—The
Secretary shall provide for—
‘‘(i) the appointment of a negotiated
rulemaking committee under section 565(a)
of such title 5 by not later than 30 days
after the end of the comment period pro-
vided for under section 564(c) of such title
5 (as shortened under subparagraph (E)),
and
‘‘(ii) the nomination of a facilitator
under section 566(c) of such title 5 by not
later than 10 days after the date of appoint-
ment of the committee.
‘‘(G) PRELIMINARY COMMITTEE REPORT.—
The negotiated rulemaking committee appointed
under subparagraph (F) shall report to the Sec-
retary, by not later than March 29, 2000, re-
garding the committee’s progress on achieving a
consensus with regard to the rulemaking pro-
ceeding and whether such consensus is likely to
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occur before 1 month before the target date for
publication of the rule. If the committee reports
that the committee has failed to make significant
progress towards such consensus or is unlikely to
reach such consensus by the target date, the Sec-
retary may terminate such process and provide
for the publication of a rule under this para-
graph through such other methods as the Sec-
retary may provide.
‘‘(H) FINAL
COMMITTEE
REPORT.—If the
committee is not terminated under subparagraph
(G), the rulemaking committee shall submit a re-
port containing a proposed rule by not later
than 1 month before the target date of publica-
tion.
‘‘(I) FINAL
EFFECT.—The Secretary shall
publish a rule under this paragraph in the Fed-
eral Register by not later than the target date of
publication.
‘‘(J) PUBLICATION OF RULE AFTER PUBLIC
COMMENT.—The Secretary shall provide for con-
sideration of such comments and republication of
such rule by not later than 1 year after the tar-
get date of publication.
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‘‘(K) EFFECTIVE DATE.—The provisions of
this paragraph shall apply to group health plans
(other than a fully insured group health plan)
for plan years beginning on or after January 1,
2001.
‘‘(3) 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 would
normally pay for comparable services under sub-
paragraph (A).
‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—
‘‘(1) IN GENERAL.—In this section, the term ‘ap-
proved clinical trial’ means a cancer clinical research
study or cancer clinical investigation approved and
funded (which may include funding through in-kind
contributions) 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:
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‘‘(i) The Department of Veterans Af-
fairs.
‘‘(ii) The Department of Defense.
‘‘(2) CONDITIONS FOR DEPARTMENTS.—The con-
ditions described in this paragraph, for a study or in-
vestigation conducted by a Department, are that the
study or investigation has been reviewed and ap-
proved through a system of peer review that the Sec-
retary 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 coverage with respect to clinical
trials.
‘‘(f) PLAN SATISFACTION OF CERTAIN REQUIREMENTS;
RESPONSIBILITIES OF FIDUCIARIES.—
‘‘(1) IN GENERAL.—For purposes of this section,
insofar as a group health plan provides benefits in the
form of health insurance coverage through a health in-
surance issuer, the plan shall be treated as meeting
the requirements of this section with respect to such
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benefits and not be considered as failing to meet such
requirements because of a failure of the issuer to meet
such requirements so long as the plan sponsor or its
representatives did not cause such failure by the
issuer.
‘‘(2) CONSTRUCTION.—Nothing in this section
shall be construed to affect or modify the responsibil-
ities of the fiduciaries of a group health plan under
part 4 of subtitle B of title I of the Employee Retire-
ment Income Security Act of 1974.
‘‘(g) STUDY AND REPORT.—
‘‘(1) STUDY.—The Secretary shall study the im-
pact on group health plans for covering routine pa-
tient care costs for individuals who are entitled to
benefits under this section and who are enrolled in an
approved cancer clinical trial program.
‘‘(2) REPORT
TO
CONGRESS.—Not later than
January 1, 2005, the Secretary shall submit a report
to Congress that contains an assessment of—
‘‘(A) any incremental cost to group health
plans resulting from the provisions of this sec-
tion;
‘‘(B) a projection of expenditures to such
plans resulting from this section; and
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‘‘(C) any impact on premiums resulting
from this section.
‘‘SEC. 9830A. PROHIBITING DISCRIMINATION AGAINST PRO-
VIDERS.
‘‘(a) IN GENERAL.—A group health plan (other than
a fully insured group health plan) shall not discriminate
with respect to participation or indemnification 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 certification. This subsection
shall not be construed as requiring the coverage under a
plan of particular benefits or services or to prohibit a plan
from including providers only to the extent necessary to
meet the needs of the plan’s participants and beneficiaries
or from establishing any measure designed to maintain
quality and control costs consistent with the responsibilities
of the plan.
‘‘(b) NO REQUIREMENT
FOR
ANY WILLING PRO-
VIDER.—Nothing in this section shall be construed as re-
quiring a group health plan that offers network coverage
to include for participation every willing provider or health
professional who meets the terms and conditions of the plan.
‘‘SEC. 9830B. GENERALLY APPLICABLE PROVISION.
‘‘In the case of a group health plan that provides bene-
fits under 2 or more coverage options, the requirements of
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this subchapter shall apply separately with respect to each
coverage option.’’.
(b) DEFINITION.—Section 9832(b) of the Internal Rev-
enue Code of 1986 is amended by adding at the end the
following:
‘‘(4) FULLY INSURED GROUP HEALTH PLAN.—
The term ‘fully insured group health plan’ means a
group health plan where benefits under the plan are
provided pursuant to the terms of an arrangement be-
tween a group health plan and a health insurance
issuer and are guaranteed by the health insurance
issuer under a contract or policy of insurance.’’.
(c) CONFORMING AMENDMENT.—Chapter 98 of the In-
ternal Revenue Code of 1986 is amended in the table of sub-
chapters in the item relating to subchapter C, by striking
‘‘Subchapter C’’ and inserting ‘‘Subchapter D’’.
SEC. 103. EFFECTIVE DATE AND RELATED RULES.
(a) IN GENERAL.—The amendments made by this sub-
title shall apply with respect to plan years beginning on
or after January 1 of the second calendar year following
the date of the enactment of this Act. The Secretary shall
issue all regulations necessary to carry out the amendments
made by this section before the effective date thereof.
(b) LIMITATION ON ENFORCEMENT ACTIONS.—No en-
forcement action shall be taken, pursuant to the amend-
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ments made by this subtitle, against a group health plan
with respect to a violation of a requirement imposed by such
amendments before the date of issuance of regulations issued
in connection with such requirement, if the plan has sought
to comply in good faith with such requirement.
Subtitle B—Right to Information
About Plans and Providers
SEC. 111. INFORMATION ABOUT PLANS.
(a) EMPLOYEE RETIREMENT INCOME SECURITY ACT
OF 1974.—
(1) IN GENERAL.—Subpart B of part 7 of sub-
title B of title I of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1185 et seq.) is
amended by adding at the end the following:
‘‘SEC. 714. HEALTH PLAN COMPARATIVE INFORMATION.
‘‘(a) REQUIREMENT.—
‘‘(1) IN GENERAL.—A group health plan, and a
health insurance issuer that provides coverage in con-
nection with group health insurance coverage, shall,
not later than 12 months after the date of enactment
of this section, and at least annually thereafter, pro-
vide for the disclosure, in a clear and accurate form
to each participant and each beneficiary who does not
reside at the same address as the participant, or upon
request to an individual eligible for coverage under
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the plan, of the information described in subsection
(b).
‘‘(2) RULE OF CONSTRUCTION.—Nothing in this
section shall be construed to prevent a plan or issuer
from entering into any agreement under which the
issuer agrees to assume responsibility for compliance
with the requirements of this section and the plan is
released from liability for such compliance.
‘‘(3) PROVISION OF INFORMATION.—Information
shall be provided to participants and beneficiaries
under this section at the address maintained by the
plan or issuer with respect to such participants or
beneficiaries.
‘‘(b) REQUIRED INFORMATION.—The informational
materials to be distributed under this section shall include
for each package option available under a group health plan
the following:
‘‘(1) A description of the covered items and serv-
ices under each such plan and any in- and out-of-net-
work features of each such plan, including a sum-
mary description of the specific exclusions from cov-
erage under the plan.
‘‘(2) A description of any cost-sharing, including
premiums, deductibles, coinsurance, and copayment
amounts, for which the participant or beneficiary will
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be responsible, including any annual or lifetime lim-
its on benefits, for each such plan.
‘‘(3) A description of any optional supplemental
benefits offered by each such plan and the terms and
conditions (including premiums or cost-sharing) for
such supplemental coverage.
‘‘(4) A description of any restrictions on pay-
ments for services furnished to a participant or bene-
ficiary by a health care professional that is not a
participating professional and the liability of the
participant or beneficiary for additional payments
for these services.
‘‘(5) A description of the service area of each
such plan, including the provision of any out-of-area
coverage.
‘‘(6) A description of the extent to which partici-
pants and beneficiaries may select the primary care
provider of their choice, including providers both
within the network and outside the network of each
such plan (if the plan permits out-of-network serv-
ices).
‘‘(7) A description of the procedures for advance
directives and organ donation decisions if the plan
maintains such procedures.
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‘‘(8) A description of the requirements and pro-
cedures to be used to obtain preauthorization for
health services (including telephone numbers and
mailing addresses), including referrals for specialty
care.
‘‘(9) A description of the definition of medical
necessity used in making coverage determinations by
each such plan.
‘‘(10) A summary of the rules and methods for
appealing coverage decisions and filing grievances
(including telephone numbers and mailing addresses),
as well as other available remedies.
‘‘(11) A summary description of any provisions
for obtaining off-formulary medications if the plan
utilizes a defined formulary for providing specific
prescription medications.
‘‘(12) A summary of the rules for access to emer-
gency room care. Also, any available educational ma-
terial regarding proper use of emergency services.
‘‘(13) A description of whether or not coverage is
provided for experimental treatments, investigational
treatments, or clinical trials and the circumstances
under which access to such treatments or trials is
made available.
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‘‘(14) A description of the specific preventative
services covered under the plan if such services are
covered.
‘‘(15) A statement regarding—
‘‘(A) the manner in which a participant or
beneficiary may access an obstetrician, gyne-
cologist, or pediatrician in accordance with sec-
tion 723 or 724; and
‘‘(B) the manner in which a participant or
beneficiary obtains continuity of care as pro-
vided for in section 726.
‘‘(16) A statement that the following informa-
tion, and instructions on obtaining such information
(including telephone numbers and, if available, Inter-
net websites), shall be made available upon request:
‘‘(A) The names, addresses, telephone num-
bers, and State licensure status of the plan’s par-
ticipating health care professionals and partici-
pating health care facilities, and, if available,
the education, training, specialty qualifications
or certifications of such professionals.
‘‘(B) A summary description of the methods
used for compensating participating health care
professionals, such as capitation, fee-for-service,
salary, or a combination thereof. The require-
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ment of this subparagraph shall not be construed
as requiring plans to provide information con-
cerning proprietary payment methodology.
‘‘(C) A summary description of the methods
used for compensating health care facilities, in-
cluding per diem, fee-for-service, capitation, bun-
dled payments, or a combination thereof. The re-
quirement of this subparagraph shall not be con-
strued as requiring plans to provide information
concerning proprietary payment methodology.
‘‘(D) A summary description of the proce-
dures used for utilization review.
‘‘(E) The list of the specific prescription
medications included in the formulary of the
plan, if the plan uses a defined formulary.
‘‘(F) A description of the specific exclusions
from coverage under the plan.
‘‘(G) Any available information related to
the availability of translation or interpretation
services for non-English speakers and people
with communication disabilities, including the
availability of audio tapes or information in
Braille.
‘‘(H) Any information that is made public
by accrediting organizations in the process of ac-
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creditation if the plan is accredited, or any ad-
ditional quality indicators that the plan makes
available.
‘‘(c) MANNER OF DISTRIBUTION.—The information de-
scribed in this section shall be distributed in an accessible
format that is understandable to an average plan partici-
pant or beneficiary.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion may be construed to prohibit a group health plan, or
health insurance issuer in connection with group health in-
surance coverage, from distributing any other additional
information determined by the plan or issuer to be impor-
tant or necessary in assisting participants and beneficiaries
or upon request potential participants and beneficiaries in
the selection of a health plan or from providing information
under subsection (b)(15) as part of the required informa-
tion.
‘‘(e) CONFORMING
REGULATIONS.—The Secretary
shall issue regulations to coordinate the requirements on
group health plans and health insurance issuers under this
section with the requirements imposed under part 1, to re-
duce duplication with respect to any information that is
required to be provided under any such requirements.
‘‘(f) HEALTH CARE PROFESSIONAL.—In this section,
the term ‘health care professional’ means a physician (as
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defined in section 1861(r) of the Social Security Act) or
other health care professional if coverage for the profes-
sional’s services is provided under the health plan involved
for the services of the professional. Such term includes a
podiatrist, optometrist, chiropractor, psychologist, dentist,
physician assistant, physical or occupational therapist and
therapy assistant, speech-language pathologist, audiologist,
registered or licensed practical nurse (including nurse prac-
titioner, clinical nurse specialist, certified registered nurse
anesthetist, and certified nurse-midwife), licensed certified
social worker, registered respiratory therapist, and certified
respiratory therapy technician.’’.
(2) CONFORMING AMENDMENTS.—
(A) Section 732(a) of the Employee Retire-
ment Income Security Act of 1974 (29 U.S.C.
1191a(a)) is amended by striking ‘‘section 711,
and inserting ‘‘sections 711 and 714’’.
(B) The table of contents in section 1 of the
Employee Retirement Income Security Act of
1974 (29 U.S.C. 1001) is amended by inserting
after the item relating to section 713, the fol-
lowing:
‘‘Sec. 714. Health plan comparative information.’’.
(b) INTERNAL REVENUE CODE OF 1986.—Subchapter
B of chapter 100 of the Internal Revenue Code of 1986 is
amended—
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(1) in the table of sections, by inserting after the
item relating to section 9812 the following new item:
‘‘Sec. 9813. Health plan comparative information.’’;
and
(2) by inserting after section 9812 the following:
‘‘SEC. 9813. HEALTH PLAN COMPARATIVE INFORMATION.
‘‘(a) REQUIREMENT.—
‘‘(1) IN GENERAL.—A group health plan shall,
not later than 12 months after the date of enactment
of this section, and at least annually thereafter, pro-
vide for the disclosure, in a clear and accurate form
to each participant and each beneficiary who does not
reside at the same address as the participant, or upon
request to an individual eligible for coverage under
the plan, of the information described in subsection
(b).
‘‘(2) RULES OF CONSTRUCTION.—Nothing in this
section shall be construed to prevent a plan from en-
tering into any agreement under which a health in-
surance issuer agrees to assume responsibility for
compliance with the requirements of this section and
the plan is released from liability for such compli-
ance.
‘‘(3) PROVISION OF INFORMATION.—Information
shall be provided to participants and beneficiaries
under this section at the address maintained by the
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plan with respect to such participants or bene-
ficiaries.
‘‘(b) REQUIRED INFORMATION.—The informational
materials to be distributed under this section shall include
for each package option available under a group health plan
the following:
‘‘(1) A description of the covered items and serv-
ices under each such plan and any in- and out-of-net-
work features of each such plan, including a sum-
mary description of the specific exclusions from cov-
erage under the plan.
‘‘(2) A description of any cost-sharing, including
premiums, deductibles, coinsurance, and copayment
amounts, for which the participant or beneficiary will
be responsible, including any annual or lifetime lim-
its on benefits, for each such plan.
‘‘(3) A description of any optional supplemental
benefits offered by each such plan and the terms and
conditions (including premiums or cost-sharing) for
such supplemental coverage.
‘‘(4) A description of any restrictions on pay-
ments for services furnished to a participant or bene-
ficiary by a health care professional that is not a
participating professional and the liability of the
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participant or beneficiary for additional payments
for these services.
‘‘(5) A description of the service area of each
such plan, including the provision of any out-of-area
coverage.
‘‘(6) A description of the extent to which partici-
pants and beneficiaries may select the primary care
provider of their choice, including providers both
within the network and outside the network of each
such plan (if the plan permits out-of-network serv-
ices).
‘‘(7) A description of the procedures for advance
directives and organ donation decisions if the plan
maintains such procedures.
‘‘(8) A description of the requirements and pro-
cedures to be used to obtain preauthorization for
health services (including telephone numbers and
mailing addresses), including referrals for specialty
care.
‘‘(9) A description of the definition of medical
necessity used in making coverage determinations by
each such plan.
‘‘(10) A summary of the rules and methods for
appealing coverage decisions and filing grievances
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(including telephone numbers and mailing addresses),
as well as other available remedies.
‘‘(11) A summary description of any provisions
for obtaining off-formulary medications if the plan
utilizes a defined formulary for providing specific
prescription medications.
‘‘(12) A summary of the rules for access to emer-
gency room care. Also, any available educational ma-
terial regarding proper use of emergency services.
‘‘(13) A description of whether or not coverage is
provided for experimental treatments, investigational
treatments, or clinical trials and the circumstances
under which access to such treatments or trials is
made available.
‘‘(14) A description of the specific preventative
services covered under the plan if such services are
covered.
‘‘(15) A statement regarding—
‘‘(A) the manner in which a participant or
beneficiary may access an obstetrician, gyne-
cologist, or pediatrician in accordance with sec-
tion 723 or 724; and
‘‘(B) the manner in which a participant or
beneficiary obtains continuity of care as pro-
vided for in section 726.
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‘‘(16) A statement that the following informa-
tion, and instructions on obtaining such information
(including telephone numbers and, if available, Inter-
net websites), shall be made available upon request:
‘‘(A) The names, addresses, telephone num-
bers, and State licensure status of the plan’s par-
ticipating health care professionals and partici-
pating health care facilities, and, if available,
the education, training, specialty qualifications
or certifications of such professionals.
‘‘(B) A summary description of the methods
used for compensating participating health care
professionals, such as capitation, fee-for-service,
salary, or a combination thereof. The require-
ment of this subparagraph shall not be construed
as requiring plans to provide information con-
cerning proprietary payment methodology.
‘‘(C) A summary description of the methods
used for compensating health care facilities, in-
cluding per diem, fee-for-service, capitation, bun-
dled payments, or a combination thereof. The re-
quirement of this subparagraph shall not be con-
strued as requiring plans to provide information
concerning proprietary payment methodology.
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‘‘(D) A summary description of the proce-
dures used for utilization review.
‘‘(E) The list of the specific prescription
medications included in the formulary of the
plan, if the plan uses a defined formulary.
‘‘(F) A description of the specific exclusions
from coverage under the plan.
‘‘(G) Any available information related to
the availability of translation or interpretation
services for non-English speakers and people
with communication disabilities, including the
availability of audio tapes or information in
Braille.
‘‘(H) Any information that is made public
by accrediting organizations in the process of ac-
creditation if the plan is accredited, or any ad-
ditional quality indicators that the plan makes
available.
‘‘(c) MANNER OF DISTRIBUTION.—The information de-
scribed in this section shall be distributed in an accessible
format that is understandable to an average plan partici-
pant or beneficiary.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion may be construed to prohibit a group health plan from
distributing any other additional information determined
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by the plan to be important or necessary in assisting par-
ticipants and beneficiaries or upon request potential par-
ticipants and beneficiaries in the selection of a health plan
or from providing information under subsection (b)(15) as
part of the required information.
‘‘(e) HEALTH CARE PROFESSIONAL.—In this section,
the term ‘health care professional’ means a physician (as
defined in section 1861(r) of the Social Security Act) or
other health care professional if coverage for the profes-
sional’s services is provided under the health plan involved
for the services of the professional. Such term includes a
podiatrist, optometrist, chiropractor, psychologist, dentist,
physician assistant, physical or occupational therapist and
therapy assistant, speech-language pathologist, audiologist,
registered or licensed practical nurse (including nurse prac-
titioner, clinical nurse specialist, certified registered nurse
anesthetist, and certified nurse-midwife), licensed certified
social worker, registered respiratory therapist, and certified
respiratory therapy technician.’’.
SEC. 112. INFORMATION ABOUT PROVIDERS.
(a) STUDY.—The Secretary of Health and Human
Services shall enter into a contract with the Institute of
Medicine for the conduct of a study, and the submission
to the Secretary of a report, that includes—
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(1) an analysis of information concerning health
care professionals that is currently available to pa-
tients, consumers, States, and professional societies,
nationally and on a State-by-State basis, including
patient preferences with respect to information about
such professionals and their competencies;
(2) an evaluation of the legal and other barriers
to the sharing of information concerning health care
professionals; and
(3) recommendations for the disclosure of infor-
mation on health care professionals, including the
competencies and professional qualifications of such
practitioners, to better facilitate patient choice, qual-
ity improvement, and market competition.
(b) REPORT.—Not later than 18 months after the date
of enactment of this Act, the Secretary of Health and
Human Services shall forward to the appropriate commit-
tees of Congress a copy of the report and study conducted
under subsection (a).
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Subtitle C—Right to Hold Health
Plans Accountable
SEC. 121. AMENDMENT TO EMPLOYEE RETIREMENT IN-
COME SECURITY ACT OF 1974.
(a) IN GENERAL.—Section 503 of the Employee Re-
tirement Income Security Act of 1974 (29 U.S.C. 1133) is
amended to read as follows:
‘‘SEC. 503. CLAIMS PROCEDURE, COVERAGE DETERMINA-
TION, GRIEVANCES AND APPEALS.
‘‘(a) CLAIMS PROCEDURE.—In accordance with regu-
lations of the Secretary, every employee benefit plan shall—
‘‘(1) provide adequate notice in writing to any
participant or beneficiary whose claim for benefits
under the plan has been denied, setting forth the spe-
cific reasons for such denial, written in a manner cal-
culated to be understood by the participant; and
‘‘(2) afford a reasonable opportunity to any par-
ticipant whose claim for benefits has been denied for
a full and fair review by the appropriate named fidu-
ciary of the decision denying the claim.
‘‘(b) COVERAGE DETERMINATIONS UNDER GROUP
HEALTH PLANS.—
‘‘(1) PROCEDURES.—
‘‘(A) IN GENERAL.—A group health plan or
health insurance issuer conducting utilization re-
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view shall ensure that procedures are in place
for—
‘‘(i) making determinations regarding
whether a participant or beneficiary is eli-
gible to receive a payment or coverage for
health services under the plan or coverage
involved and any cost-sharing amount that
the participant or beneficiary is required to
pay with respect to such service;
‘‘(ii) notifying a covered participant or
beneficiary (or the authorized representative
of such participant or beneficiary) and the
treating health care professionals involved
regarding determinations made under the
plan or issuer and any additional pay-
ments that the participant or beneficiary
may be required to make with respect to
such service; and
‘‘(iii) responding to requests, either
written or oral, for coverage determinations
or for internal appeals from a participant
or beneficiary (or the authorized representa-
tive of such participant or beneficiary) or
the treating health care professional with
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the consent of the participant or bene-
ficiary.
‘‘(B) ORAL REQUESTS.—With respect to an
oral request described in subparagraph (A)(iii),
a group health plan or health insurance issuer
may require that the requesting individual pro-
vide written evidence of such request.
‘‘(2) TIMELINE FOR MAKING DETERMINATIONS.—
‘‘(A) ROUTINE DETERMINATION.—A group
health plan or a health insurance issuer shall
maintain procedures to ensure that prior author-
ization determinations concerning the provision
of non-emergency items or services are made
within 30 days from the date on which the re-
quest for a determination is submitted, except
that such period may be extended where certain
circumstances exist that are determined by the
Secretary to be beyond control of the plan or
issuer.
‘‘(B) EXPEDITED DETERMINATION.—
‘‘(i) IN GENERAL.—A prior authoriza-
tion determination under this subsection
shall be made within 72 hours, in accord-
ance with the medical exigencies of the case,
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after a request is received by the plan or
issuer under clause (ii) or (iii).
‘‘(ii) REQUEST
BY
PARTICIPANT
OR
BENEFICIARY.—A plan or issuer shall
maintain procedures for expediting a prior
authorization determination under this sub-
section upon the request of a participant or
beneficiary if, based on such a request, the
plan or issuer determines that the normal
time for making such a determination could
seriously jeopardize the life or health of the
participant or beneficiary.
‘‘(iii) DOCUMENTATION
BY
HEALTH
CARE
PROFESSIONAL.—A plan or issuer
shall maintain procedures for expediting a
prior authorization determination under
this subsection if the request involved indi-
cates that the treating health care profes-
sional has reasonably documented, based on
the medical exigencies, that a determination
under the procedures described in subpara-
graph (A) could seriously jeopardize the life
or health of the participant or beneficiary.
‘‘(C) CONCURRENT
DETERMINATIONS.—A
plan or issuer shall maintain procedures to cer-
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tify or deny coverage of an extended stay or ad-
ditional services.
‘‘(D) RETROSPECTIVE DETERMINATION.—A
plan or issuer shall maintain procedures to en-
sure that, with respect to the retrospective review
of a determination made under paragraph (1),
the determination shall be made within 30 work-
ing days of the date on which the plan or issuer
receives necessary information.
‘‘(3) NOTICE OF DETERMINATIONS.—
‘‘(A) ROUTINE DETERMINATION.—With re-
spect to a coverage determination of a plan or
issuer under paragraph (2)(A), the plan or
issuer shall issue notice of such determination to
the participant or beneficiary (or the authorized
representative of the participant or beneficiary)
and, consistent with the medical exigencies of the
case, to the treating health care professional in-
volved not later than 2 working days after the
date on which the determination is made.
‘‘(B) EXPEDITED
DETERMINATION.—With
respect to a coverage determination of a plan or
issuer under paragraph (2)(B), the plan or
issuer shall issue notice of such determination to
the participant or beneficiary (or the authorized
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representative of the participant or beneficiary),
and consistent with the medical exigencies of the
case, to the treating health care professional in-
volved within the 72 hour period described in
paragraph (2)(B).
‘‘(C) CONCURRENT REVIEWS.—With respect
to the determination under a plan or issuer
under paragraph (2)(C) to certify or deny cov-
erage of an extended stay or additional services,
the plan or issuer shall issue notice of such deter-
mination to the treating health care professional
and to the participant or beneficiary involved
(or the authorized representative of the partici-
pant or beneficiary) within 1 working day of the
determination.
‘‘(D) RETROSPECTIVE REVIEWS.—With re-
spect to the retrospective review under a plan or
issuer of a determination made under paragraph
(2)(D), the plan or issuer shall issue written no-
tice of an approval or disapproval of a deter-
mination under this subparagraph to the partic-
ipant or beneficiary (or the authorized represent-
ative of the participant or beneficiary) and
health care provider involved within 5 working
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days of the date on which such determination is
made.
‘‘(E) REQUIREMENTS
OF
NOTICE
OF
AD-
VERSE COVERAGE DETERMINATIONS.—A written
notice of an adverse coverage determination
under this subsection, or of an expedited adverse
coverage determination under paragraph (2)(B),
shall be provided to the participant or bene-
ficiary (or the authorized representative of the
participant or beneficiary) and treating health
care professional (if any) involved and shall
include—
‘‘(i) the reasons for the determination
(including the clinical or scientific-evidence
based rationale used in making the deter-
mination) written in a manner to be under-
standable to the average participant or ben-
eficiary;
‘‘(ii) the procedures for obtaining addi-
tional information concerning the deter-
mination; and
‘‘(iii) notification of the right to ap-
peal the determination and instructions on
how to initiate an appeal in accordance
with subsection (d).
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‘‘(c) GRIEVANCES.—A group health plan or a health
insurance issuer shall have written procedures for address-
ing grievances between the plan or issuer offering health
insurance coverage in connection with a group health plan
and a participant or beneficiary. Determinations under
such procedures shall be non-appealable.
‘‘(d) INTERNAL APPEAL OF COVERAGE DETERMINA-
TIONS.—
‘‘(1) RIGHT TO APPEAL.—
‘‘(A) IN GENERAL.—A participant or bene-
ficiary (or the authorized representative of the
participant or beneficiary) or the treating health
care professional with the consent of the partici-
pant or beneficiary (or the authorized represent-
ative of the participant or beneficiary), may ap-
peal any adverse coverage determination under
subsection (b) under the procedures described in
this subsection.
‘‘(B) TIME FOR APPEAL.—A plan or issuer
shall ensure that a participant or beneficiary
has a period of not less than 180 days beginning
on the date of an adverse coverage determination
under subsection (b) in which to appeal such de-
termination under this subsection.
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‘‘(C) FAILURE TO ACT.—The failure of a
plan or issuer to issue a determination under
subsection (b) within the applicable timeline es-
tablished for such a determination under such
subsection shall be treated as an adverse coverage
determination for purposes of proceeding to in-
ternal review under this subsection.
‘‘(2) RECORDS.—A group health plan and a
health insurance issuer shall maintain written
records, for at least 6 years, with respect to any ap-
peal under this subsection for purposes of internal
quality assurance and improvement. Nothing in the
preceding sentence shall be construed as preventing a
plan and issuer from entering into an agreement
under which the issuer agrees to assume responsibility
for compliance with the requirements of this section
and the plan is released from liability for such com-
pliance.
‘‘(3) 
ROUTINE
DETERMINATIONS.—A 
group
health plan or a health insurance issuer shall com-
plete the consideration of an appeal of an adverse
routine determination under this subsection not later
than 30 working days after the date on which a re-
quest for such appeal is received.
‘‘(4) EXPEDITED DETERMINATION.—
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‘‘(A) IN
GENERAL.—An expedited deter-
mination with respect to an appeal under this
subsection shall be made in accordance with the
medical exigencies of the case, but in no case
more than 72 hours after the request for such ap-
peal is received by the plan or issuer under sub-
paragraph (B) or (C).
‘‘(B) REQUEST BY PARTICIPANT OR BENE-
FICIARY.—A plan or issuer shall maintain pro-
cedures for expediting a prior authorization de-
termination under this subsection upon the re-
quest of a participant or beneficiary if, based on
such a request, the plan or issuer determines that
the normal time for making such a determina-
tion could seriously jeopardize the life or health
of the participant or beneficiary.
‘‘(C) DOCUMENTATION
BY
HEALTH
CARE
PROFESSIONAL.—A plan or issuer shall main-
tain procedures for expediting a prior authoriza-
tion determination under this subsection if the
request involved indicates that the treating
health care professional has reasonably docu-
mented, based on the medical exigencies of the
case that a determination under the procedures
described in paragraph (2) could seriously jeop-
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ardize the life or health of the participant or
beneficiary.
‘‘(5) CONDUCT OF REVIEW.—A review of an ad-
verse coverage determination under this subsection
shall be conducted by an individual with appropriate
expertise who was not directly involved in the initial
determination.
‘‘(6) LACK OF MEDICAL NECESSITY.—A review of
an appeal under this subsection relating to a deter-
mination to deny coverage based on a lack of medical
necessity and appropriateness, or based on an experi-
mental or investigational treatment, shall be made
only by a physician with appropriate expertise, in-
cluding age-appropriate expertise, who was not in-
volved in the initial determination.
‘‘(7) NOTICE.—
‘‘(A) IN GENERAL.—Written notice of a de-
termination made under an internal review
process shall be issued to the participant or bene-
ficiary (or the authorized representative of the
participant or beneficiary) and the treating
health care professional not later than 2 working
days after the completion of the review (or with-
in the 72-hour period referred to in paragraph
(4) if applicable).
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‘‘(B) 
ADVERSE
COVERAGE
DETERMINA-
TIONS.—With respect to an adverse coverage de-
termination made under this subsection, the no-
tice 
described 
in 
subparagraph 
(A) 
shall
include—
‘‘(i) the reasons for the determination
(including the clinical or scientific-evidence
based rationale used in making the deter-
mination) written in a manner to be under-
standable to the average participant or ben-
eficiary;
‘‘(ii) the procedures for obtaining addi-
tional information concerning the deter-
mination; and
‘‘(iii) notification of the right to an
independent external review under sub-
section (e) and instructions on how to ini-
tiate such a review.
‘‘(e) INDEPENDENT EXTERNAL REVIEW.—
‘‘(1) ACCESS TO REVIEW.—
‘‘(A) IN GENERAL.—A group health plan or
a health insurance issuer offering health insur-
ance coverage in connection with a group health
plan shall have written procedures to permit a
participant or beneficiary (or the authorized rep-
102
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resentative of the participant or beneficiary) ac-
cess to an independent external review with re-
spect to an adverse coverage determination con-
cerning a particular item or service (including a
circumstance treated as an adverse coverage de-
termination under subparagraph (B)) where—
‘‘(i) the particular item or service
involved—
‘‘(I)(aa) would be a covered ben-
efit, when medically necessary and ap-
propriate under the terms and condi-
tions of the plan, and the item or serv-
ice has been determined not to be medi-
cally necessary and appropriate under
the internal appeals process required
under subsection (d) or there has been
a failure to issue a coverage determina-
tion as described in subparagraph (B);
and
‘‘(bb)(AA) the amount of such
item or service involved exceeds a sig-
nificant financial threshold; or
‘‘(BB) there is a significant risk
of placing the life or health of the par-
ticipant or beneficiary in jeopardy; or
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‘‘(II) would be a covered benefit,
when not considered experimental or
investigational under the terms and
conditions of the plan, and the item or
service has been determined to be ex-
perimental or investigational under the
internal 
appeals 
process 
required
under subsection (d) or there has been
a failure to issue a coverage determina-
tion as described in subparagraph (B);
and
‘‘(ii) the participant or beneficiary has
completed the internal appeals process
under subsection (d) with respect to such de-
termination.
‘‘(B) FAILURE TO ACT.—The failure of a
plan or issuer to issue a coverage determination
under subsection (d)(6) within the applicable
timeline established for such a determination
under such subsection shall be treated as an ad-
verse coverage determination for purposes of pro-
ceeding to independent external review under
this subsection.
‘‘(2) INITIATION OF THE INDEPENDENT EXTER-
NAL REVIEW PROCESS.—
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‘‘(A) FILING OF REQUEST.—A participant
or beneficiary (or the authorized representative
of the participant or beneficiary) who desires to
have an independent external review conducted
under this subsection shall file a written request
for such a review with the plan or issuer in-
volved not later than 30 working days after the
receipt of a final denial of a claim under sub-
section (d). Any such request shall include the
consent of the participant or beneficiary (or the
authorized representative of the participant or
beneficiary) for the release of medical informa-
tion and records to independent external review-
ers regarding the participant or beneficiary.
‘‘(B) TIMEFRAME FOR SELECTION OF AP-
PEALS ENTITY.—Not later than 5 working days
after the receipt of a request under subparagraph
(A), or earlier in accordance with the medical
exigencies of the case, the plan or issuer involved
shall—
‘‘(i) select an external appeals entity
under paragraph (3)(A) that shall be re-
sponsible for designating an independent ex-
ternal reviewer under paragraph (3)(B);
and
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‘‘(ii) provide notice of such selection to
the participant or beneficiary (which shall
include the name and address of the entity).
‘‘(C) PROVISION
OF
INFORMATION.—Not
later than 5 working days after the plan or
issuer provides the notice required under sub-
paragraph (B)(ii), or earlier in accordance with
the medical exigencies of the case, the plan,
issuer, participant, beneficiary or physician (of
the participant or beneficiary) involved shall for-
ward necessary information (including, only in
the case of a plan or issuer, medical records, any
relevant review criteria, the clinical rationale
consistent with the terms and conditions of the
contract between the plan or issuer and the par-
ticipant or beneficiary for the coverage denial,
and evidence of the coverage of the participant or
beneficiary) to the qualified external appeals en-
tity designated under paragraph (3)(A).
‘‘(D) 
FOLLOW-UP
WRITTEN
NOTIFICA-
TION.—The plan or issuer involved shall send a
follow-up written notification, in a timely man-
ner, to the participant or beneficiary (or the au-
thorized representative of the participant or ben-
eficiary) and the plan administrator, indicating
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that an independent external review has been
initiated.
‘‘(3) CONDUCT OF INDEPENDENT EXTERNAL RE-
VIEW.—
‘‘(A) DESIGNATION OF EXTERNAL APPEALS
ENTITY BY PLAN OR ISSUER.—
‘‘(i) IN GENERAL.—A plan or issuer
that receives a request for an independent
external review under paragraph (2)(A)
shall designate a qualified entity described
in clause (ii), in a manner designed to en-
sure that the entity so designated will make
a decision in an unbiased manner, to serve
as the external appeals entity.
‘‘(ii) QUALIFIED ENTITIES.—A quali-
fied entity shall be—
‘‘(I) an independent external re-
view entity licensed or credentialed by
a State;
‘‘(II) a State agency established
for the purpose of conducting inde-
pendent external reviews;
‘‘(III) any entity under contract
with the Federal Government to pro-
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vide independent external review serv-
ices;
‘‘(IV) any entity accredited as an
independent external review entity by
an accrediting body recognized by the
Secretary for such purpose; or
‘‘(V) any other entity meeting cri-
teria established by the Secretary for
purposes of this subparagraph.
‘‘(B) DESIGNATION
OF
INDEPENDENT
EX-
TERNAL REVIEWER BY EXTERNAL APPEALS ENTI-
TY.—The external appeals entity designated
under subparagraph (A) shall, not later than 30
days after the date on which such entity is des-
ignated under subparagraph (A), or earlier in
accordance with the medical exigencies of the
case, designate one or more individuals to serve
as independent external reviewers with respect to
a request received under paragraph (2)(A). Such
reviewers shall be independent medical experts
who shall—
‘‘(i) be appropriately credentialed or
licensed in any State to deliver health care
services;
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‘‘(ii) not have any material, profes-
sional, familial, or financial affiliation
with the case under review, the participant
or beneficiary involved, the treating health
care professional, the institution where the
treatment would take place, or the manufac-
turer of any drug, device, procedure, or
other therapy proposed for the participant
or beneficiary whose treatment is under re-
view;
‘‘(iii) have expertise (including age-ap-
propriate expertise) in the diagnosis or
treatment under review and be a physician
of the same specialty, when reasonably
available, as the physician treating the par-
ticipant or beneficiary or recommending or
prescribing the treatment in question;
‘‘(iv) receive only reasonable and cus-
tomary compensation from the group health
plan or health insurance issuer in connec-
tion with the independent external review
that is not contingent on the decision ren-
dered by the reviewer; and
‘‘(v) not be held liable for decisions re-
garding medical determinations (but may
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be held liable for actions that are arbitrary
and capricious).
‘‘(4) STANDARD OF REVIEW.—
‘‘(A) IN GENERAL.—An independent exter-
nal reviewer shall—
‘‘(i) make an independent determina-
tion based on the valid, relevant, scientific
and clinical evidence to determine the med-
ical 
necessity, 
appropriateness, 
experi-
mental or investigational nature of the pro-
posed treatment; and
‘‘(ii) take into consideration appro-
priate and available information, including
any evidence-based decision making or clin-
ical practice guidelines used by the group
health plan or health insurance issuer;
timely evidence or information submitted by
the plan, issuer, patient or patient’s physi-
cian; the patient’s medical record; expert
consensus including both generally accepted
medical practice and recognized best prac-
tice; medical literature as defined in section
556(5) of the Federal Food, Drug, and Cos-
metic Act; the following standard reference
compendia: The American Hospital For-
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mulary 
Service-Drug 
Information, 
the
American Dental Association Accepted Den-
tal Therapeutics, and the United States
Pharmacopoeia-Drug 
Information; 
and
findings, studies, or research conducted by
or under the auspices of Federal Govern-
ment agencies and nationally recognized
Federal research institutes including the
Agency for Healthcare Research and Qual-
ity, National Institutes of Health, National
Academy of Sciences, Health Care Financ-
ing Administration, and any national
board recognized by the National Institutes
of Health for the purposes of evaluating the
medical value of health services.
‘‘(B) NOTICE.—The plan or issuer involved
shall ensure that the participant or beneficiary
receives notice, within 30 days after the deter-
mination of the independent medical expert, re-
garding the actions of the plan or issuer with re-
spect to the determination of such expert under
the independent external review.
‘‘(5) TIMEFRAME FOR REVIEW.—
‘‘(A) IN GENERAL.—The independent exter-
nal reviewer shall complete a review of an ad-
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verse coverage determination in accordance with
the medical exigencies of the case.
‘‘(B) 
EXPEDITED
REVIEW.—Notwith-
standing subparagraph (A), a review described
in such subparagraph shall be completed not
later than 72 hours after the later of—
‘‘(i) the date on which such reviewer is
designated; or
‘‘(ii) the date on which all information
necessary to completing such review is re-
ceived;
if the completion of such review in a period of
time in excess of 72 hours would seriously jeop-
ardize the life or health of the participant or
beneficiary.
‘‘(C) LIMITATION.—Notwithstanding sub-
paragraph (A), and except as provided in sub-
paragraph (B), a review described in subpara-
graph (A) shall be completed not later than 30
working days after the later of—
‘‘(i) the date on which such reviewer is
designated; or
‘‘(ii) the date on which all information
necessary to completing such review is re-
ceived.
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‘‘(6) BINDING DETERMINATION AND ACCESS TO
CARE.—
‘‘(A) IN GENERAL.—The determination of
an independent external reviewer under this sub-
section shall be binding upon the plan or issuer
if the provisions of this subsection or the proce-
dures implemented under such provisions were
complied with by the independent external re-
viewer.
‘‘(B) TIMETABLE FOR COMMENCEMENT OF
CARE.—Where an independent external reviewer
determines that the participant or beneficiary is
entitled to coverage of the items or services that
were the subject of the review, the reviewer shall
establish a timeframe, in accordance with the
medical exigencies of the case, during which the
plan or issuer shall comply with the decision of
the reviewer with respect to the coverage of such
items or services under the terms and conditions
of the plan.
‘‘(C) FAILURE TO COMPLY.—If a plan or
issuer fails to comply with the timeframe estab-
lished under subparagraph (B) with respect to a
participant or beneficiary, where such failure to
comply is caused by the plan or issuer, the par-
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ticipant or beneficiary may obtain the items or
services involved (in a manner consistent with
the determination of the independent external re-
viewer) from any provider regardless of whether
such provider is a participating provider under
the plan or coverage.
‘‘(D) REIMBURSEMENT.—
‘‘(i) IN
GENERAL.—Where a partici-
pant or beneficiary obtains items or services
in accordance with subparagraph (C), the
plan or issuer involved shall provide for re-
imbursement of the costs of such items of
services. Such reimbursement shall be made
to the treating provider or to the partici-
pant or beneficiary (in the case of a partici-
pant or beneficiary who pays for the costs
of such items or services).
‘‘(ii) AMOUNT.—The plan or issuer
shall fully reimburse a provider, partici-
pant or beneficiary under clause (i) for the
total costs of the items or services provided
(regardless of any plan limitations that
may apply to the coverage of such items of
services) so long as—
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‘‘(I) the items or services would
have been covered under the terms of
the plan or coverage if provided by the
plan or issuer; and
‘‘(II) the items or services were
provided in a manner consistent with
the determination of the independent
external reviewer.
‘‘(E) FAILURE
TO
REIMBURSE.—Where a
plan or issuer fails to provide reimbursement to
a provider, participant or beneficiary in accord-
ance with this paragraph, the provider, partici-
pant or beneficiary may commence a civil action
(or utilize other remedies available under law) to
recover only the amount of any such reimburse-
ment that is unpaid and any necessary legal
costs or expenses (including attorneys’ fees) in-
curred in recovering such reimbursement.
‘‘(7) STUDY.—Not later than 2 years after the
date of enactment of this section, the General Ac-
counting Office shall conduct a study of a statistically
appropriate sample of completed independent external
reviews. Such study shall include an assessment of the
process involved during an independent external re-
view and the basis of decisionmaking by the inde-
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pendent external reviewer. The results of such study
shall be submitted to the appropriate committees of
Congress.
‘‘(8) EFFECT ON CERTAIN PROVISIONS.—Nothing
in this section shall be construed as affecting or modi-
fying section 514 of this Act with respect to a group
health plan.
‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to prohibit a plan administrator or
plan fiduciary or health plan medical director from request-
ing an independent external review by an independent ex-
ternal reviewer without first completing the internal review
process.
‘‘(g) DEFINITIONS.—In this section:
‘‘(1) ADVERSE COVERAGE DETERMINATION.—The
term ‘adverse coverage determination’ means a cov-
erage determination under the plan which results in
a denial of coverage or reimbursement.
‘‘(2) COVERAGE
DETERMINATION.—The term
‘coverage determination’ means with respect to items
and services for which coverage may be provided
under a health plan, a determination of whether or
not such items and services are covered or reimburs-
able under the coverage and terms of the contract.
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‘‘(3) GRIEVANCE.—The term ‘grievance’ means
any complaint made by a participant or beneficiary
that does not involve a coverage determination.
‘‘(4) GROUP HEALTH PLAN.—The term ‘group
health plan’ shall have the meaning given such term
in section 733(a). In applying this paragraph, ex-
cepted benefits described in section 733(c) shall not be
treated as benefits consisting of medical care.
‘‘(5) HEALTH INSURANCE COVERAGE.—The term
‘health insurance coverage’ has the meaning given
such term in section 733(b)(1). In applying this
paragraph, excepted benefits described in section
733(c) shall not be treated as benefits consisting of
medical care.
‘‘(6) HEALTH
INSURANCE
ISSUER.—The term
‘health insurance issuer’ has the meaning given such
term in section 733(b)(2).
‘‘(7) PRIOR AUTHORIZATION DETERMINATION.—
The term ‘prior authorization determination’ means a
coverage determination prior to the provision of the
items and services as a condition of coverage of the
items and services under the coverage.
‘‘(8) TREATING HEALTH CARE PROFESSIONAL.—
The term ‘treating health care professional’ with re-
spect to a group health plan, health insurance issuer
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or provider sponsored organization means a physi-
cian (medical doctor or doctor of osteopathy) or other
health care practitioner who is acting within the
scope of his or her State licensure or certification for
the delivery of health care services and who is pri-
marily responsible for delivering those services to the
participant or beneficiary.
‘‘(9) UTILIZATION REVIEW.—The term ‘utiliza-
tion review’ with respect to a group health plan or
health insurance coverage means a set of formal tech-
niques designed to monitor the use of, or evaluate the
clinical necessity, appropriateness, efficacy, or effi-
ciency of, health care services, procedures, or settings.
Techniques may include ambulatory review, prospec-
tive review, second opinion, certification, concurrent
review, case management, discharge planning or ret-
rospective review.’’.
(b) ENFORCEMENT.—Section 502(c) of the Employee
Retirement Income Security Act of 1974 (29 U.S.C.
1132(c)) is amended by adding at the end the following:
‘‘(8) The Secretary may assess a civil penalty against
any plan of up to $10,000 for the plan’s failure or refusal
to comply with any timeline applicable under section
503(e) or any determination under such section, except that
in any case in which treatment was not commenced by the
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plan in accordance with the determination of an inde-
pendent external reviewer, the Secretary shall assess a civil
penalty of $10,000 against the plan and the plan shall pay
such penalty to the participant or beneficiary involved.’’.
(c) CONFORMING AMENDMENT.—The table of contents
in section 1 of the Employee Retirement Income Security
Act of 1974 is amended by striking the item relating to
section 503 and inserting the following new item:
‘‘Sec. 503. Claims procedures, coverage determination, grievances and appeals.’’.
(d) EFFECTIVE DATE.—The amendments made by this
section shall apply with respect to plan years beginning on
or after 1 year after the date of enactment of this Act. The
Secretary shall issue all regulations necessary to carry out
the amendments made by this section before the effective
date thereof.
TITLE II—WOMEN’S HEALTH AND
CANCER RIGHTS
SEC. 201. WOMEN’S HEALTH AND CANCER RIGHTS.
(a) SHORT TITLE.—This section may be cited as the
‘‘Women’s Health and Cancer Rights Act of 1999’’.
(b) FINDINGS.—Congress finds that—
(1) the offering and operation of health plans af-
fect commerce among the States;
(2) health care providers located in a State serve
patients who reside in the State and patients who re-
side in other States; and
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(3) in order to provide for uniform treatment of
health care providers and patients among the States,
it is necessary to cover health plans operating in 1
State as well as health plans operating among the
several States.
(c) AMENDMENTS TO ERISA.—
(1) IN GENERAL.—Subpart B of part 7 of sub-
title B of title I of the Employee Retirement Income
Security Act of 1974, as amended by section 111(a),
is further amended by adding at the end the fol-
lowing:
‘‘SEC. 715. REQUIRED COVERAGE FOR MINIMUM HOSPITAL
STAY FOR MASTECTOMIES AND LYMPH NODE
DISSECTIONS 
FOR 
THE 
TREATMENT 
OF
BREAST CANCER AND COVERAGE FOR SEC-
ONDARY CONSULTATIONS.
‘‘(a) INPATIENT CARE.—
‘‘(1) IN GENERAL.—A group health plan, and a
health insurance issuer providing health insurance
coverage in connection with a group health plan, that
provides medical and surgical benefits shall ensure
that inpatient coverage with respect to the treatment
of breast cancer is provided for a period of time as
is determined by the attending physician, in consulta-
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tion with the patient, to be medically necessary and
appropriate following—
‘‘(A) a mastectomy;
‘‘(B) a lumpectomy; or
‘‘(C) a lymph node dissection for the treat-
ment of breast cancer.
‘‘(2) EXCEPTION.—Nothing in this section shall
be construed as requiring the provision of inpatient
coverage if the attending physician and patient deter-
mine that a shorter period of hospital stay is medi-
cally appropriate.
‘‘(b) PROHIBITION ON CERTAIN MODIFICATIONS.—In
implementing the requirements of this section, a group
health plan, and a health insurance issuer providing health
insurance coverage in connection with a group health plan,
may not modify the terms and conditions of coverage based
on the determination by a participant or beneficiary to re-
quest less than the minimum coverage required under sub-
section (a).
‘‘(c) NOTICE.—A group health plan, and a health in-
surance issuer providing health insurance coverage in con-
nection with a group health plan shall provide notice to
each participant and beneficiary under such plan regarding
the coverage required by this section in accordance with reg-
ulations promulgated by the Secretary. Such notice shall
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be in writing and prominently positioned in any literature
or correspondence made available or distributed by the plan
or issuer and shall be transmitted—
‘‘(1) in the next mailing made by the plan or
issuer to the participant or beneficiary;
‘‘(2) as part of any yearly informational packet
sent to the participant or beneficiary; or
‘‘(3) not later than January 1, 2000;
whichever is earlier.
‘‘(d) SECONDARY CONSULTATIONS.—
‘‘(1) IN GENERAL.—A group health plan, and a
health insurance issuer providing health insurance
coverage in connection with a group health plan, that
provides coverage with respect to medical and sur-
gical services provided in relation to the diagnosis
and treatment of cancer shall ensure that full coverage
is provided for secondary consultations by specialists
in the appropriate medical fields (including pathol-
ogy, radiology, and oncology) to confirm or refute
such diagnosis. Such plan or issuer shall ensure that
full coverage is provided for such secondary consulta-
tion whether such consultation is based on a positive
or negative initial diagnosis. In any case in which
the attending physician certifies in writing that serv-
ices necessary for such a secondary consultation are
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not sufficiently available from specialists operating
under the plan with respect to whose services coverage
is otherwise provided under such plan or by such
issuer, such plan or issuer shall ensure that coverage
is provided with respect to the services necessary for
the secondary consultation with any other specialist
selected by the attending physician for such purpose
at no additional cost to the individual beyond that
which the individual would have paid if the specialist
was participating in the network of the plan.
‘‘(2) EXCEPTION.—Nothing in paragraph (1)
shall be construed as requiring the provision of sec-
ondary consultations where the patient determines not
to seek such a consultation.
‘‘(e) PROHIBITION ON PENALTIES OR INCENTIVES.—
A group health plan, and a health insurance issuer pro-
viding health insurance coverage in connection with a
group health plan, may not—
‘‘(1) penalize or otherwise reduce or limit the re-
imbursement of a provider or specialist because the
provider or specialist provided care to a participant
or beneficiary in accordance with this section;
‘‘(2) provide financial or other incentives to a
physician or specialist to induce the physician or spe-
cialist to keep the length of inpatient stays of patients
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following a mastectomy, lumpectomy, or a lymph
node dissection for the treatment of breast cancer
below certain limits or to limit referrals for secondary
consultations; or
‘‘(3) provide financial or other incentives to a
physician or specialist to induce the physician or spe-
cialist to refrain from referring a participant or bene-
ficiary for a secondary consultation that would other-
wise be covered by the plan or coverage involved
under subsection (d).’’.
(2) CLERICAL AMENDMENT.—The table of con-
tents in section 1 of the Employee Retirement Income
Security Act of 1974 is amended by inserting after
the item relating to section 714 the following new
item:
‘‘Sec. 715. Required coverage for minimum hospital stay for mastectomies and
lymph node dissections for the treatment of breast cancer and
coverage for secondary consultations.’’.
(d) AMENDMENTS
TO PHSA RELATING
TO
THE
GROUP MARKET.—Subpart 2 of part A of title XXVII of
the Public Health Service Act (42 U.S.C. 300gg-4 et seq.)
is amended by adding at the end the following new section:
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‘‘SEC. 2707. REQUIRED COVERAGE FOR MINIMUM HOSPITAL
STAY FOR MASTECTOMIES AND LYMPH NODE
DISSECTIONS 
FOR 
THE 
TREATMENT 
OF
BREAST CANCER AND COVERAGE FOR SEC-
ONDARY CONSULTATIONS.
‘‘(a) INPATIENT CARE.—
‘‘(1) IN GENERAL.—A group health plan, and a
health insurance issuer providing health insurance
coverage in connection with a group health plan, that
provides medical and surgical benefits shall ensure
that inpatient coverage with respect to the treatment
of breast cancer is provided for a period of time as
is determined by the attending physician, in consulta-
tion with the patient, to be medically necessary and
appropriate following—
‘‘(A) a mastectomy;
‘‘(B) a lumpectomy; or
‘‘(C) a lymph node dissection for the treat-
ment of breast cancer.
‘‘(2) EXCEPTION.—Nothing in this section shall
be construed as requiring the provision of inpatient
coverage if the attending physician and patient deter-
mine that a shorter period of hospital stay is medi-
cally appropriate.
‘‘(b) PROHIBITION ON CERTAIN MODIFICATIONS.—In
implementing the requirements of this section, a group
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health plan, and a health insurance issuer providing health
insurance coverage in connection with a group health plan,
may not modify the terms and conditions of coverage based
on the determination by a participant or beneficiary to re-
quest less than the minimum coverage required under sub-
section (a).
‘‘(c) NOTICE.—A group health plan, and a health in-
surance issuer providing health insurance coverage in con-
nection with a group health plan shall provide notice to
each participant and beneficiary under such plan regarding
the coverage required by this section in accordance with reg-
ulations promulgated by the Secretary. Such notice shall
be in writing and prominently positioned in any literature
or correspondence made available or distributed by the plan
or issuer and shall be transmitted—
‘‘(1) in the next mailing made by the plan or
issuer to the participant or beneficiary;
‘‘(2) as part of any yearly informational packet
sent to the participant or beneficiary; or
‘‘(3) not later than January 1, 2000;
whichever is earlier.
‘‘(d) SECONDARY CONSULTATIONS.—
‘‘(1) IN GENERAL.—A group health plan, and a
health insurance issuer providing health insurance
coverage in connection with a group health plan that
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provides coverage with respect to medical and sur-
gical services provided in relation to the diagnosis
and treatment of cancer shall ensure that full coverage
is provided for secondary consultations by specialists
in the appropriate medical fields (including pathol-
ogy, radiology, and oncology) to confirm or refute
such diagnosis. Such plan or issuer shall ensure that
full coverage is provided for such secondary consulta-
tion whether such consultation is based on a positive
or negative initial diagnosis. In any case in which
the attending physician certifies in writing that serv-
ices necessary for such a secondary consultation are
not sufficiently available from specialists operating
under the plan with respect to whose services coverage
is otherwise provided under such plan or by such
issuer, such plan or issuer shall ensure that coverage
is provided with respect to the services necessary for
the secondary consultation with any other specialist
selected by the attending physician for such purpose
at no additional cost to the individual beyond that
which the individual would have paid if the specialist
was participating in the network of the plan.
‘‘(2) EXCEPTION.—Nothing in paragraph (1)
shall be construed as requiring the provision of sec-
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ondary consultations where the patient determines not
to seek such a consultation.
‘‘(e) PROHIBITION ON PENALTIES OR INCENTIVES.—
A group health plan, and a health insurance issuer pro-
viding health insurance coverage in connection with a
group health plan, may not—
‘‘(1) penalize or otherwise reduce or limit the re-
imbursement of a provider or specialist because the
provider or specialist provided care to a participant
or beneficiary in accordance with this section;
‘‘(2) provide financial or other incentives to a
physician or specialist to induce the physician or spe-
cialist to keep the length of inpatient stays of patients
following a mastectomy, lumpectomy, or a lymph
node dissection for the treatment of breast cancer
below certain limits or to limit referrals for secondary
consultations; or
‘‘(3) provide financial or other incentives to a
physician or specialist to induce the physician or spe-
cialist to refrain from referring a participant or bene-
ficiary for a secondary consultation that would other-
wise be covered by the plan or coverage involved
under subsection (d).’’.
(e) AMENDMENTS TO PHSA RELATING TO THE INDI-
VIDUAL MARKET.—The first subpart 3 of part B of title
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XXVII of the Public Health Service Act (42 U.S.C. 300gg–
51 et seq.) (relating to other requirements) (42 U.S.C.
300gg-51 et seq.) is amended—
(1) by redesignating such subpart as subpart 2;
and
(2) by adding at the end the following:
‘‘SEC. 2753. REQUIRED COVERAGE FOR MINIMUM HOSPITAL
STAY FOR MASTECTOMIES AND LYMPH NODE
DISSECTIONS 
FOR 
THE 
TREATMENT 
OF
BREAST 
CANCER 
AND 
SECONDARY 
CON-
SULTATIONS.
‘‘The provisions of section 2707 shall apply to health
insurance coverage offered by a health insurance issuer in
the individual market in the same manner as they apply
to health insurance coverage offered by a health insurance
issuer in connection with a group health plan in the small
or large group market.’’.
(f) AMENDMENTS TO THE IRC.—
(1) IN GENERAL.—Subchapter B of chapter 100
of the Internal Revenue Code of 1986, as amended by
section 111(b), is further amended by inserting after
section 9813 the following:
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‘‘SEC. 9814. REQUIRED COVERAGE FOR MINIMUM HOSPITAL
STAY FOR MASTECTOMIES AND LYMPH NODE
DISSECTIONS 
FOR 
THE 
TREATMENT 
OF
BREAST CANCER AND COVERAGE FOR SEC-
ONDARY CONSULTATIONS.
‘‘(a) INPATIENT CARE.—
‘‘(1) IN GENERAL.—A group health plan that
provides medical and surgical benefits shall ensure
that inpatient coverage with respect to the treatment
of breast cancer is provided for a period of time as
is determined by the attending physician, in consulta-
tion with the patient, to be medically necessary and
appropriate following—
‘‘(A) a mastectomy;
‘‘(B) a lumpectomy; or
‘‘(C) a lymph node dissection for the treat-
ment of breast cancer.
‘‘(2) EXCEPTION.—Nothing in this section shall
be construed as requiring the provision of inpatient
coverage if the attending physician and patient deter-
mine that a shorter period of hospital stay is medi-
cally appropriate.
‘‘(b) PROHIBITION ON CERTAIN MODIFICATIONS.—In
implementing the requirements of this section, a group
health plan may not modify the terms and conditions of
coverage based on the determination by a participant or
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beneficiary to request less than the minimum coverage re-
quired under subsection (a).
‘‘(c) NOTICE.—A group health plan shall provide no-
tice to each participant and beneficiary under such plan
regarding the coverage required by this section in accord-
ance with regulations promulgated by the Secretary. Such
notice shall be in writing and prominently positioned in
any literature or correspondence made available or distrib-
uted by the plan and shall be transmitted—
‘‘(1) in the next mailing made by the plan to the
participant or beneficiary;
‘‘(2) as part of any yearly informational packet
sent to the participant or beneficiary; or
‘‘(3) not later than January 1, 2000;
whichever is earlier.
‘‘(d) SECONDARY CONSULTATIONS.—
‘‘(1) IN GENERAL.—A group health plan that
provides coverage with respect to medical and sur-
gical services provided in relation to the diagnosis
and treatment of cancer shall ensure that full coverage
is provided for secondary consultations by specialists
in the appropriate medical fields (including pathol-
ogy, radiology, and oncology) to confirm or refute
such diagnosis. Such plan or issuer shall ensure that
full coverage is provided for such secondary consulta-
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tion whether such consultation is based on a positive
or negative initial diagnosis. In any case in which
the attending physician certifies in writing that serv-
ices necessary for such a secondary consultation are
not sufficiently available from specialists operating
under the plan with respect to whose services coverage
is otherwise provided under such plan or by such
issuer, such plan or issuer shall ensure that coverage
is provided with respect to the services necessary for
the secondary consultation with any other specialist
selected by the attending physician for such purpose
at no additional cost to the individual beyond that
which the individual would have paid if the specialist
was participating in the network of the plan.
‘‘(2) EXCEPTION.—Nothing in paragraph (1)
shall be construed as requiring the provision of sec-
ondary consultations where the patient determines not
to seek such a consultation.
‘‘(e) PROHIBITION ON PENALTIES.—A group health
plan may not—
‘‘(1) penalize or otherwise reduce or limit the re-
imbursement of a provider or specialist because the
provider or specialist provided care to a participant
or beneficiary in accordance with this section;
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‘‘(2) provide financial or other incentives to a
physician or specialist to induce the physician or spe-
cialist to keep the length of inpatient stays of patients
following a mastectomy, lumpectomy, or a lymph
node dissection for the treatment of breast cancer
below certain limits or to limit referrals for secondary
consultations; or
‘‘(3) provide financial or other incentives to a
physician or specialist to induce the physician or spe-
cialist to refrain from referring a participant or bene-
ficiary for a secondary consultation that would other-
wise be covered by the plan involved under subsection
(d).’’.
(2) CLERICAL AMENDMENT.—The table of con-
tents for chapter 100 of such Code is amended by in-
serting after the item relating to section 9813 the fol-
lowing new item:
‘‘Sec. 9814. Required coverage for minimum hospital stay for mastectomies and
lymph node dissections for the treatment of breast cancer and
coverage for secondary consultations.’’.
TITLE III—GENETIC
INFORMATION AND SERVICES
SEC. 301. SHORT TITLE.
This title may be cited as the ‘‘Genetic Information
Nondiscrimination in Health Insurance Act of 1999’’.
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SEC. 302. AMENDMENTS TO EMPLOYEE RETIREMENT IN-
COME SECURITY ACT OF 1974.
(a) PROHIBITION OF HEALTH DISCRIMINATION ON
THE BASIS OF GENETIC INFORMATION OR GENETIC SERV-
ICES.—
(1) NO ENROLLMENT RESTRICTION FOR GENETIC
SERVICES.—Section 702(a)(1)(F) of the Employee Re-
tirement Income Security Act of 1974 (29 U.S.C.
1182(a)(1)(F)) is amended by inserting before the pe-
riod the following: ‘‘(including information about a
request for or receipt of genetic services)’’.
(2) NO
DISCRIMINATION
IN
GROUP
PREMIUMS
BASED ON PREDICTIVE GENETIC INFORMATION.—Sub-
part B of part 7 of subtitle B of title I of the Em-
ployee Retirement Income Security Act of 1974, as
amended by sections 111(a) and 201, is further
amended by adding at the end the following:
‘‘SEC. 
716. 
PROHIBITING 
PREMIUM 
DISCRIMINATION
AGAINST GROUPS ON THE BASIS OF PRE-
DICTIVE GENETIC INFORMATION.
‘‘A group health plan, or a health insurance issuer of-
fering group health insurance coverage in connection with
a group health plan, shall not adjust premium or contribu-
tion amounts for a group on the basis of predictive genetic
information concerning any individual (including a de-
pendent) or family member of the individual (including in-
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formation about a request for or receipt of genetic serv-
ices).’’.
(3) CONFORMING AMENDMENTS.—
(A) IN
GENERAL.—Section 702(b) of the
Employee Retirement Income Security Act of
1974 (29 U.S.C. 1182(b)) is amended by adding
at the end the following:
‘‘(3) REFERENCE TO RELATED PROVISION.—For
a provision prohibiting the adjustment of premium or
contribution amounts for a group under a group
health plan on the basis of predictive genetic informa-
tion (including information about a request for or re-
ceipt of genetic services), see section 716.’’.
(B) TABLE
OF
CONTENTS.—The table of
contents in section 1 of the Employee Retirement
Income Security Act of 1974, as amended by sec-
tions 111(a) and 201, is further amended by in-
serting after the item relating to section 715 the
following new item:
‘‘Sec. 716. Prohibiting premium discrimination against groups on the basis of
predictive genetic information.’’.
(b) LIMITATION ON COLLECTION OF PREDICTIVE GE-
NETIC INFORMATION.—Section 702 of the Employee Retire-
ment Income Security Act of 1974 (29 U.S.C. 1182) is
amended by adding at the end the following:
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‘‘(c) COLLECTION OF PREDICTIVE GENETIC INFORMA-
TION.—
‘‘(1) LIMITATION ON REQUESTING OR REQUIRING
PREDICTIVE GENETIC INFORMATION.—Except as pro-
vided in paragraph (2), a group health plan, or a
health insurance issuer offering health insurance cov-
erage in connection with a group health plan, shall
not request or require predictive genetic information
concerning any individual (including a dependent) or
family member of the individual (including informa-
tion about a request for or receipt of genetic services).
‘‘(2) INFORMATION
NEEDED
FOR
DIAGNOSIS,
TREATMENT, OR PAYMENT.—
‘‘(A) IN GENERAL.—Notwithstanding para-
graph (1), a group health plan, or a health in-
surance issuer offering health insurance coverage
in connection with a group health plan, that
provides health care items and services to an in-
dividual or dependent may request (but may not
require) that such individual or dependent dis-
close, or authorize the collection or disclosure of,
predictive genetic information for purposes of di-
agnosis, treatment, or payment relating to the
provision of health care items and services to
such individual or dependent.
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‘‘(B) NOTICE
OF
CONFIDENTIALITY
PRAC-
TICES AND DESCRIPTION OF SAFEGUARDS.—As a
part of a request under subparagraph (A), the
group health plan, or a health insurance issuer
offering health insurance coverage in connection
with a group health plan, shall provide to the in-
dividual or dependent a description of the proce-
dures in place to safeguard the confidentiality,
as described in subsection (d), of such predictive
genetic information.
‘‘(d) CONFIDENTIALITY
WITH
RESPECT
TO
PRE-
DICTIVE GENETIC INFORMATION.—
‘‘(1) NOTICE OF CONFIDENTIALITY PRACTICES.—
‘‘(A) PREPARATION OF WRITTEN NOTICE.—
A group health plan, or a health insurance
issuer offering health insurance coverage in con-
nection with a group health plan, shall post or
provide, in writing and in a clear and con-
spicuous manner, notice of the plan or issuer’s
confidentiality practices, that shall include—
‘‘(i) a description of an individual’s
rights with respect to predictive genetic in-
formation;
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‘‘(ii) the procedures established by the
plan or issuer for the exercise of the individ-
ual’s rights; and
‘‘(iii) the right to obtain a copy of the
notice of the confidentiality practices re-
quired under this subsection.
‘‘(B) MODEL
NOTICE.—The Secretary, in
consultation with the National Committee on
Vital and Health Statistics and the National As-
sociation of Insurance Commissioners, and after
notice and opportunity for public comment, shall
develop and disseminate model notices of con-
fidentiality practices. Use of the model notice
shall serve as a defense against claims of receiv-
ing inappropriate notice.
‘‘(2) 
ESTABLISHMENT
OF
SAFEGUARDS.—A
group health plan, or a health insurance issuer offer-
ing health insurance coverage in connection with a
group health plan, shall establish and maintain ap-
propriate administrative, technical, and physical
safeguards to protect the confidentiality, security, ac-
curacy, and integrity of predictive genetic informa-
tion created, received, obtained, maintained, used,
transmitted, or disposed of by such plan or issuer.’’.
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(c) DEFINITIONS.—Section 733(d) of the Employee Re-
tirement Income Security Act of 1974 (29 U.S.C. 1191b(d))
is amended by adding at the end the following:
‘‘(5) FAMILY MEMBER.—The term ‘family mem-
ber’ means with respect to an individual—
‘‘(A) the spouse of the individual;
‘‘(B) a dependent child of the individual,
including a child who is born to or placed for
adoption with the individual; and
‘‘(C) all other individuals related by blood
to the individual or the spouse or child described
in subparagraph (A) or (B).
‘‘(6) GENETIC INFORMATION.—The term ‘genetic
information’ means information about genes, gene
products, or inherited characteristics that may derive
from an individual or a family member (including
information about a request for or receipt of genetic
services).
‘‘(7) GENETIC
SERVICES.—The term ‘genetic
services’ means health services provided to obtain, as-
sess, or interpret genetic information for diagnostic
and therapeutic purposes, and for genetic education
and counseling.
‘‘(8) PREDICTIVE GENETIC INFORMATION.—
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‘‘(A) IN GENERAL.—The term ‘predictive ge-
netic information’ means, in the absence of
symptoms, clinical signs, or a diagnosis of the
condition related to such information—
‘‘(i) information about an individual’s
genetic tests;
‘‘(ii) information about genetic tests of
family members of the individual; or
‘‘(iii) information about the occurrence
of a disease or disorder in family members.
‘‘(B) EXCEPTIONS.—The term ‘predictive
genetic information’ shall not include—
‘‘(i) information about the sex or age of
the individual;
‘‘(ii) information derived from phys-
ical tests, such as the chemical, blood, or
urine analyses of the individual including
cholesterol tests; and
‘‘(iii) 
information 
about 
physical
exams of the individual.
‘‘(9) GENETIC
TEST.—The term ‘genetic test’
means the analysis of human DNA, RNA, chro-
mosomes, proteins, and certain metabolites, including
analysis of genotypes, mutations, phenotypes, or
karyotypes, for the purpose of predicting risk of dis-
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ease in asymptomatic or undiagnosed individuals.
Such term does not include physical tests, such as the
chemical, blood, or urine analyses of the individual
including cholesterol tests, and physical exams of the
individual, in order to detect symptoms, clinical
signs, or a diagnosis of disease.’’.
(d) EFFECTIVE DATE.—Except as provided in this sec-
tion, this section and the amendments made by this section
shall apply with respect to group health plans for plan
years beginning 1 year after the date of the enactment of
this Act.
SEC. 303. AMENDMENTS TO THE PUBLIC HEALTH SERVICE
ACT.
(a) AMENDMENTS RELATING TO THE GROUP MAR-
KET.—
(1) PROHIBITION
OF
HEALTH
DISCRIMINATION
ON
THE
BASIS
OF
GENETIC
INFORMATION
IN
THE
GROUP MARKET.—
(A) NO ENROLLMENT RESTRICTION FOR GE-
NETIC SERVICES.—Section 2702(a)(1)(F) of the
Public Health Service Act (42 U.S.C. 300gg–
1(a)(1)(F)) is amended by inserting before the
period the following: ‘‘(including information
about a request for or receipt of genetic serv-
ices)’’.
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(B) NO
DISCRIMINATION
IN
PREMIUMS
BASED ON PREDICTIVE GENETIC INFORMATION.—
Subpart 2 of part A of title XXVII of the Public
Health Service Act, as amended by section 201,
is further amended by adding at the end the fol-
lowing new section:
‘‘SEC. 
2708. 
PROHIBITING 
PREMIUM 
DISCRIMINATION
AGAINST GROUPS ON THE BASIS OF PRE-
DICTIVE 
GENETIC 
INFORMATION 
IN 
THE
GROUP MARKET.
‘‘A group health plan, or a health insurance issuer of-
fering group health insurance coverage in connection with
a group health plan shall not adjust premium or contribu-
tion amounts for a group on the basis of predictive genetic
information concerning any individual (including a de-
pendent) or family member of the individual (including in-
formation about a request for or receipt of genetic serv-
ices).’’.
(C) 
CONFORMING
AMENDMENT.—Section
2702(b) of the Public Health Service Act (42
U.S.C. 300gg–1(b)) is amended by adding at the
end the following:
‘‘(3) REFERENCE TO RELATED PROVISION.—For
a provision prohibiting the adjustment of premium or
contribution amounts for a group under a group
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health plan on the basis of predictive genetic informa-
tion (including information about a request for or re-
ceipt of genetic services), see section 2708.’’.
(D) LIMITATION ON COLLECTION AND DIS-
CLOSURE
OF
PREDICTIVE
GENETIC
INFORMA-
TION.—Section 2702 of the Public Health Service
Act (42 U.S.C. 300gg–1) is amended by adding
at the end the following:
‘‘(c) COLLECTION OF PREDICTIVE GENETIC INFORMA-
TION.—
‘‘(1) LIMITATION ON REQUESTING OR REQUIRING
PREDICTIVE GENETIC INFORMATION.—Except as pro-
vided in paragraph (2), a group health plan, or a
health insurance issuer offering health insurance cov-
erage in connection with a group health plan, shall
not request or require predictive genetic information
concerning any individual (including a dependent) or
a family member of the individual (including infor-
mation about a request for or receipt of genetic serv-
ices).
‘‘(2) INFORMATION
NEEDED
FOR
DIAGNOSIS,
TREATMENT, OR PAYMENT.—
‘‘(A) IN GENERAL.—Notwithstanding para-
graph (1), a group health plan, or a health in-
surance issuer offering health insurance coverage
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in connection with a group health plan, that
provides health care items and services to an in-
dividual or dependent may request (but may not
require) that such individual or dependent dis-
close, or authorize the collection or disclosure of,
predictive genetic information for purposes of di-
agnosis, treatment, or payment relating to the
provision of health care items and services to
such individual or dependent.
‘‘(B) NOTICE
OF
CONFIDENTIALITY
PRAC-
TICES AND DESCRIPTION OF SAFEGUARDS.—As a
part of a request under subparagraph (A), the
group health plan, or a health insurance issuer
offering health insurance coverage in connection
with a group health plan, shall provide to the in-
dividual or dependent a description of the proce-
dures in place to safeguard the confidentiality,
as described in subsection (d), of such predictive
genetic information.
‘‘(d) CONFIDENTIALITY
WITH
RESPECT
TO
PRE-
DICTIVE GENETIC INFORMATION.—
‘‘(1) NOTICE OF CONFIDENTIALITY PRACTICES.—
‘‘(A) PREPARATION OF WRITTEN NOTICE.—
A group health plan, or a health insurance
issuer offering health insurance coverage in con-
144
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nection with a group health plan, shall post or
provide, in writing and in a clear and con-
spicuous manner, notice of the plan or issuer’s
confidentiality practices, that shall include—
‘‘(i) a description of an individual’s
rights with respect to predictive genetic in-
formation;
‘‘(ii) the procedures established by the
plan or issuer for the exercise of the individ-
ual’s rights; and
‘‘(iii) the right to obtain a copy of the
notice of the confidentiality practices re-
quired under this subsection.
‘‘(B) MODEL
NOTICE.—The Secretary, in
consultation with the National Committee on
Vital and Health Statistics and the National As-
sociation of Insurance Commissioners, and after
notice and opportunity for public comment, shall
develop and disseminate model notices of con-
fidentiality practices. Use of the model notice
shall serve as a defense against claims of receiv-
ing inappropriate notice.
‘‘(2) 
ESTABLISHMENT
OF
SAFEGUARDS.—A
group health plan, or a health insurance issuer offer-
ing health insurance coverage in connection with a
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group health plan, shall establish and maintain ap-
propriate administrative, technical, and physical
safeguards to protect the confidentiality, security, ac-
curacy, and integrity of predictive genetic informa-
tion created, received, obtained, maintained, used,
transmitted, or disposed of by such plan or issuer.’’.
(2) DEFINITIONS.—Section 2791(d) of the Public
Health Service Act (42 U.S.C. 300gg–91(d)) is
amended by adding at the end the following:
‘‘(15) FAMILY MEMBER.—The term ‘family mem-
ber’ means, with respect to an individual—
‘‘(A) the spouse of the individual;
‘‘(B) a dependent child of the individual,
including a child who is born to or placed for
adoption with the individual; and
‘‘(C) all other individuals related by blood
to the individual or the spouse or child described
in subparagraph (A) or (B).
‘‘(16) GENETIC
INFORMATION.—The term ‘ge-
netic information’ means information about genes,
gene products, or inherited characteristics that may
derive from an individual or a family member (in-
cluding information about a request for or receipt of
genetic services).
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‘‘(17) GENETIC
SERVICES.—The term ‘genetic
services’ means health services provided to obtain, as-
sess, or interpret genetic information for diagnostic
and therapeutic purposes, and for genetic education
and counseling.
‘‘(18) PREDICTIVE GENETIC INFORMATION.—
‘‘(A) IN GENERAL.—The term ‘predictive ge-
netic information’ means, in the absence of
symptoms, clinical signs, or a diagnosis of the
condition related to such information—
‘‘(i) information about an individual’s
genetic tests;
‘‘(ii) information about genetic tests of
family members of the individual; or
‘‘(iii) information about the occurrence
of a disease or disorder in family members.
‘‘(B) EXCEPTIONS.—The term ‘predictive
genetic information’ shall not include—
‘‘(i) information about the sex or age of
the individual;
‘‘(ii) information derived from phys-
ical tests, such as the chemical, blood, or
urine analyses of the individual including
cholesterol tests; and
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‘‘(iii) 
information 
about 
physical
exams of the individual.
‘‘(19) GENETIC TEST.—The term ‘genetic test’
means the analysis of human DNA, RNA, chro-
mosomes, proteins, and certain metabolites, including
analysis of genotypes, mutations, phenotypes, or
karyotypes, for the purpose of predicting risk of dis-
ease in asymptomatic or undiagnosed individuals.
Such term does not include physical tests, such as the
chemical, blood, or urine analyses of the individual
including cholesterol tests, and physical exams of the
individual, in order to detect symptoms, clinical
signs, or a diagnosis of disease.’’.
(b) AMENDMENT RELATING TO THE INDIVIDUAL MAR-
KET.—Subpart 2 of part B of title XXVII of the Public
Health Service Act, as amended by section 201, is further
amended by adding at the end the following new section:
‘‘SEC. 2754. PROHIBITION OF HEALTH DISCRIMINATION ON
THE BASIS OF PREDICTIVE GENETIC INFOR-
MATION.
‘‘(a) PROHIBITION ON PREDICTIVE GENETIC INFORMA-
TION AS A CONDITION OF ELIGIBILITY.—A health insurance
issuer offering health insurance coverage in the individual
market may not use predictive genetic information as a
condition of eligibility of an individual to enroll in indi-
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HR 2990 EAS
vidual health insurance coverage (including information
about a request for or receipt of genetic services).
‘‘(b) PROHIBITION ON PREDICTIVE GENETIC INFORMA-
TION IN SETTING PREMIUM RATES.—A health insurance
issuer offering health insurance coverage in the individual
market shall not adjust premium rates for individuals on
the basis of predictive genetic information concerning such
an individual (including a dependent) or a family member
of the individual (including information about a request
for or receipt of genetic services).
‘‘(c) COLLECTION OF PREDICTIVE GENETIC INFORMA-
TION.—
‘‘(1) LIMITATION ON REQUESTING OR REQUIRING
PREDICTIVE GENETIC INFORMATION.—Except as pro-
vided in paragraph (2), a health insurance issuer of-
fering health insurance coverage in the individual
market shall not request or require predictive genetic
information concerning any individual (including a
dependent) or a family member of the individual (in-
cluding information about a request for or receipt of
genetic services).
‘‘(2) INFORMATION
NEEDED
FOR
DIAGNOSIS,
TREATMENT, OR PAYMENT.—
‘‘(A) IN GENERAL.—Notwithstanding para-
graph (1), a health insurance issuer offering
149
HR 2990 EAS
health insurance coverage in the individual mar-
ket that provides health care items and services
to an individual or dependent may request (but
may not require) that such individual or de-
pendent disclose, or authorize the collection or
disclosure of, predictive genetic information for
purposes of diagnosis, treatment, or payment re-
lating to the provision of health care items and
services to such individual or dependent.
‘‘(B) NOTICE
OF
CONFIDENTIALITY
PRAC-
TICES AND DESCRIPTION OF SAFEGUARDS.—As a
part of a request under subparagraph (A), the
health insurance issuer offering health insurance
coverage in the individual market shall provide
to the individual or dependent a description of
the procedures in place to safeguard the con-
fidentiality, as described in subsection (d), of
such predictive genetic information.
‘‘(d) CONFIDENTIALITY
WITH
RESPECT
TO
PRE-
DICTIVE GENETIC INFORMATION.—
‘‘(1) NOTICE OF CONFIDENTIALITY PRACTICES.—
‘‘(A) PREPARATION OF WRITTEN NOTICE.—
A health insurance issuer offering health insur-
ance coverage in the individual market shall post
or provide, in writing and in a clear and con-
150
HR 2990 EAS
spicuous manner, notice of the issuer’s confiden-
tiality practices, that shall include—
‘‘(i) a description of an individual’s
rights with respect to predictive genetic in-
formation;
‘‘(ii) the procedures established by the
issuer for the exercise of the individual’s
rights; and
‘‘(iii) the right to obtain a copy of the
notice of the confidentiality practices re-
quired under this subsection.
‘‘(B) MODEL
NOTICE.—The Secretary, in
consultation with the National Committee on
Vital and Health Statistics and the National As-
sociation of Insurance Commissioners, and after
notice and opportunity for public comment, shall
develop and disseminate model notices of con-
fidentiality practices. Use of the model notice
shall serve as a defense against claims of receiv-
ing inappropriate notice.
‘‘(2) 
ESTABLISHMENT
OF
SAFEGUARDS.—A
health insurance issuer offering health insurance cov-
erage in the individual market shall establish and
maintain appropriate administrative, technical, and
physical safeguards to protect the confidentiality, se-
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HR 2990 EAS
curity, accuracy, and integrity of predictive genetic
information created, received, obtained, maintained,
used, transmitted, or disposed of by such issuer.’’.
(c) EFFECTIVE DATE.—The amendments made by this
section shall apply with respect to—
(1) group health plans, and health insurance
coverage offered in connection with group health
plans, for plan years beginning after 1 year after the
date of enactment of this Act; and
(2) health insurance coverage offered, sold,
issued, renewed, in effect, or operated in the indi-
vidual market after 1 year after the date of enactment
of this Act.
SEC. 304. AMENDMENTS TO THE INTERNAL REVENUE CODE
OF 1986.
(a) PROHIBITION OF HEALTH DISCRIMINATION ON
THE BASIS OF GENETIC INFORMATION OR GENETIC SERV-
ICES.—
(1) NO ENROLLMENT RESTRICTION FOR GENETIC
SERVICES.—Section 9802(a)(1)(F) of the Internal
Revenue Code of 1986 is amended by inserting before
the period the following: ‘‘(including information
about a request for or receipt of genetic services)’’.
(2) NO
DISCRIMINATION
IN
GROUP
PREMIUMS
BASED ON PREDICTIVE GENETIC INFORMATION.—
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(A) IN GENERAL.—Subchapter B of chapter
100 of the Internal Revenue Code of 1986, as
amended by sections 111(b) and 201, is further
amended by adding at the end the following:
‘‘SEC. 
9815. 
PROHIBITING 
PREMIUM 
DISCRIMINATION
AGAINST GROUPS ON THE BASIS OF PRE-
DICTIVE GENETIC INFORMATION.
‘‘A group health plan shall not adjust premium or con-
tribution amounts for a group on the basis of predictive
genetic information concerning any individual (including
a dependent) or a family member of the individual (includ-
ing information about a request for or receipt of genetic
services).’’.
(B) 
CONFORMING
AMENDMENT.—Section
9802(b) of the Internal Revenue Code of 1986 is
amended by adding at the end the following:
‘‘(3) REFERENCE TO RELATED PROVISION.—For
a provision prohibiting the adjustment of premium or
contribution amounts for a group under a group
health plan on the basis of predictive genetic informa-
tion (including information about a request for or the
receipt of genetic services), see section 9815.’’.
(C) AMENDMENT TO TABLE OF SECTIONS.—
The table of sections for subchapter B of chapter
100 of the Internal Revenue Code of 1986, as
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amended by sections 111(b) and 201, is further
amended by adding at the end the following:
‘‘Sec. 9816. Prohibiting premium discrimination against groups on the basis of
predictive genetic information.’’.
(b) LIMITATION ON COLLECTION OF PREDICTIVE GE-
NETIC INFORMATION.—Section 9802 of the Internal Rev-
enue Code of 1986 is amended by adding at the end the
following:
‘‘(d) COLLECTION OF PREDICTIVE GENETIC INFORMA-
TION.—
‘‘(1) LIMITATION ON REQUESTING OR REQUIRING
PREDICTIVE GENETIC INFORMATION.—Except as pro-
vided in paragraph (2), a group health plan shall not
request or require predictive genetic information con-
cerning any individual (including a dependent) or a
family member of the individual (including informa-
tion about a request for or receipt of genetic services).
‘‘(2) INFORMATION
NEEDED
FOR
DIAGNOSIS,
TREATMENT, OR PAYMENT.—
‘‘(A) IN GENERAL.—Notwithstanding para-
graph (1), a group health plan that provides
health care items and services to an individual
or dependent may request (but may not require)
that such individual or dependent disclose, or
authorize the collection or disclosure of, pre-
dictive genetic information for purposes of diag-
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nosis, treatment, or payment relating to the pro-
vision of health care items and services to such
individual or dependent.
‘‘(B) NOTICE
OF
CONFIDENTIALITY
PRAC-
TICES; DESCRIPTION
OF
SAFEGUARDS.—As a
part of a request under subparagraph (A), the
group health plan shall provide to the individual
or dependent a description of the procedures in
place to safeguard the confidentiality, as de-
scribed in subsection (e), of such predictive ge-
netic information.
‘‘(e) CONFIDENTIALITY WITH RESPECT TO PREDICTIVE
GENETIC INFORMATION.—
‘‘(1) NOTICE OF CONFIDENTIALITY PRACTICES.—
‘‘(A) PREPARATION OF WRITTEN NOTICE.—
A group health plan shall post or provide, in
writing and in a clear and conspicuous manner,
notice of the plan’s confidentiality practices, that
shall include—
‘‘(i) a description of an individual’s
rights with respect to predictive genetic in-
formation;
‘‘(ii) the procedures established by the
plan for the exercise of the individual’s
rights; and
155
HR 2990 EAS
‘‘(iii) the right to obtain a copy of the
notice of the confidentiality practices re-
quired under this subsection.
‘‘(B) MODEL
NOTICE.—The Secretary, in
consultation with the National Committee on
Vital and Health Statistics and the National As-
sociation of Insurance Commissioners, and after
notice and opportunity for public comment, shall
develop and disseminate model notices of con-
fidentiality practices. Use of the model notice
shall serve as a defense against claims of receiv-
ing inappropriate notice.
‘‘(2) 
ESTABLISHMENT
OF
SAFEGUARDS.—A
group health plan shall establish and maintain ap-
propriate administrative, technical, and physical
safeguards to protect the confidentiality, security, ac-
curacy, and integrity of predictive genetic informa-
tion created, received, obtained, maintained, used,
transmitted, or disposed of by such plan.’’.
(c) DEFINITIONS.—Section 9832(d) of the Internal
Revenue Code of 1986 is amended by adding at the end
the following:
‘‘(6) FAMILY MEMBER.—The term ‘family mem-
ber’ means, with respect to an individual—
‘‘(A) the spouse of the individual;
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‘‘(B) a dependent child of the individual,
including a child who is born to or placed for
adoption with the individual; and
‘‘(C) all other individuals related by blood
to the individual or the spouse or child described
in subparagraph (A) or (B).
‘‘(7) GENETIC INFORMATION.—The term ‘genetic
information’ means information about genes, gene
products, or inherited characteristics that may derive
from an individual or a family member (including
information about a request for or receipt of genetic
services).
‘‘(8) GENETIC
SERVICES.—The term ‘genetic
services’ means health services provided to obtain, as-
sess, or interpret genetic information for diagnostic
and therapeutic purposes, and for genetic education
and counseling.
‘‘(9) PREDICTIVE GENETIC INFORMATION.—
‘‘(A) IN GENERAL.—The term ‘predictive ge-
netic information’ means, in the absence of
symptoms, clinical signs, or a diagnosis of the
condition related to such information—
‘‘(i) information about an individual’s
genetic tests;
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‘‘(ii) information about genetic tests of
family members of the individual; or
‘‘(iii) information about the occurrence
of a disease or disorder in family members.
‘‘(B) EXCEPTIONS.—The term ‘predictive
genetic information’ shall not include—
‘‘(i) information about the sex or age of
the individual;
‘‘(ii) information derived from phys-
ical tests, such as the chemical, blood, or
urine analyses of the individual including
cholesterol tests; and
‘‘(iii) 
information 
about 
physical
exams of the individual.
‘‘(10) GENETIC TEST.—The term ‘genetic test’
means the analysis of human DNA, RNA, chro-
mosomes, proteins, and certain metabolites, including
analysis of genotypes, mutations, phenotypes, or
karyotypes, for the purpose of predicting risk of dis-
ease in asymptomatic or undiagnosed individuals.
Such term does not include physical tests, such as the
chemical, blood, or urine analyses of the individual
including cholesterol tests, and physical exams of the
individual, in order to detect symptoms, clinical
signs, or a diagnosis of disease.’’.
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(d) EFFECTIVE DATE.—Except as provided in this sec-
tion, this section and the amendments made by this section
shall apply with respect to group health plans for plan
years beginning after 1 year after the date of the enactment
of this Act.
TITLE IV—HEALTHCARE
RESEARCH AND QUALITY
SEC. 401. SHORT TITLE.
This title may be cited as the ‘‘Healthcare Research
and Quality Act of 1999’’.
SEC. 402. AMENDMENT TO THE PUBLIC HEALTH SERVICE
ACT.
Title IX of the Public Health Service Act (42 U.S.C.
299 et seq.) is amended to read as follows:
‘‘TITLE 
IX—AGENCY 
FOR
HEALTHCARE RESEARCH AND
QUALITY
‘‘PART A—ESTABLISHMENT AND GENERAL
DUTIES
‘‘SEC. 901. MISSION AND DUTIES.
‘‘(a) IN GENERAL.—There is established within the
Public Health Service an agency to be known as the Agency
for Healthcare Research and Quality. In carrying out this
subsection, the Secretary shall redesignate the Agency for
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Health Care Policy and Research as the Agency for
Healthcare Research and Quality.
‘‘(b) MISSION.—The purpose of the Agency is to en-
hance the quality, appropriateness, and effectiveness of
healthcare services, and access to such services, through the
establishment of a broad base of scientific research and
through the promotion of improvements in clinical and
health system practices, including the prevention of diseases
and other health conditions. The Agency shall promote
healthcare quality improvement by—
‘‘(1) conducting and supporting research that de-
velops and presents scientific evidence regarding all
aspects of healthcare, including—
‘‘(A) the development and assessment of
methods for enhancing patient participation in
their own care and for facilitating shared pa-
tient-physician decision-making;
‘‘(B) the outcomes, effectiveness, and cost-ef-
fectiveness of healthcare practices, including pre-
ventive measures and long-term care;
‘‘(C) existing and innovative technologies;
‘‘(D) the costs and utilization of, and access
to healthcare;
‘‘(E) the ways in which healthcare services
are organized, delivered, and financed and the
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interaction and impact of these factors on the
quality of patient care;
‘‘(F) methods for measuring quality and
strategies for improving quality; and
‘‘(G) ways in which patients, consumers,
purchasers, and practitioners acquire new infor-
mation about best practices and health benefits,
the determinants and impact of their use of this
information;
‘‘(2) synthesizing and disseminating available
scientific evidence for use by patients, consumers,
practitioners, providers, purchasers, policy makers,
and educators; and
‘‘(3) advancing private and public efforts to im-
prove healthcare quality.
‘‘(c) REQUIREMENTS
WITH
RESPECT
TO
RURAL
AREAS AND PRIORITY POPULATIONS.—In carrying out sub-
section (b), the Director shall undertake and support re-
search, demonstration projects, and evaluations with respect
to the delivery of health services—
‘‘(1) in rural areas (including frontier areas);
‘‘(2) for low-income groups, and minority
groups;
‘‘(3) for children;
‘‘(4) for elderly; and
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‘‘(5) for people with special healthcare needs, in-
cluding disabilities, chronic care and end-of-life
healthcare.
‘‘(d) APPOINTMENT OF DIRECTOR.—There shall be at
the head of the Agency an official to be known as the Direc-
tor for Healthcare Research and Quality. The Director shall
be appointed by the Secretary. The Secretary, acting
through the Director, shall carry out the authorities and
duties established in this title.
‘‘SEC. 902. GENERAL AUTHORITIES.
‘‘(a) IN GENERAL.—In carrying out section 901(b), the
Director shall support demonstration projects, conduct and
support research, evaluations, training, research networks,
multi-disciplinary centers, technical assistance, and the dis-
semination of information, on healthcare, and on systems
for the delivery of such care, including activities with re-
spect to—
‘‘(1) the quality, effectiveness, efficiency, appro-
priateness and value of healthcare services;
‘‘(2) quality measurement and improvement;
‘‘(3) the outcomes, cost, cost-effectiveness, and use
of healthcare services and access to such services;
‘‘(4) clinical practice, including primary care
and practice-oriented research;
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‘‘(5) healthcare technologies, facilities, and equip-
ment;
‘‘(6) healthcare costs, productivity, organization,
and market forces;
‘‘(7) health promotion and disease prevention,
including clinical preventive services;
‘‘(8) health statistics, surveys, database develop-
ment, and epidemiology; and
‘‘(9) medical liability.
‘‘(b) HEALTH SERVICES TRAINING GRANTS.—
‘‘(1) IN GENERAL.—The Director may provide
training grants in the field of health services research
related to activities authorized under subsection (a),
to include pre- and post-doctoral fellowships and
training programs, young investigator awards, and
other programs and activities as appropriate. In car-
rying out this subsection, the Director shall make use
of funds made available under section 487 as well as
other appropriated funds.
‘‘(2) REQUIREMENTS.—In developing priorities
for the allocation of training funds under this sub-
section, the Director shall take into consideration
shortages in the number of trained researchers ad-
dressing the priority populations.
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‘‘(c) MULTIDISCIPLINARY
CENTERS.—The Director
may provide financial assistance to assist in meeting the
costs of planning and establishing new centers, and oper-
ating existing and new centers, for multidisciplinary health
services research, demonstration projects, evaluations,
training, and policy analysis with respect to the matters
referred to in subsection (a).
‘‘(d) RELATION TO CERTAIN AUTHORITIES REGARD-
ING SOCIAL SECURITY.—Activities authorized in this sec-
tion shall be appropriately coordinated with experiments,
demonstration projects, and other related activities author-
ized by the Social Security Act and the Social Security
Amendments of 1967. Activities under subsection (a)(2) of
this section that affect the programs under titles XVIII, XIX
and XXI of the Social Security Act shall be carried out
consistent with section 1142 of such Act.
‘‘(e) DISCLAIMER.—The Agency shall not mandate na-
tional standards of clinical practice or quality healthcare
standards. Recommendations resulting from projects funded
and published by the Agency shall include a corresponding
disclaimer.
‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to imply that the Agency’s role is
to mandate a national standard or specific approach to
quality measurement and reporting. In research and qual-
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ity improvement activities, the Agency shall consider a wide
range of choices, providers, healthcare delivery systems, and
individual preferences.
‘‘PART B—HEALTHCARE IMPROVEMENT
RESEARCH
‘‘SEC. 911. HEALTHCARE OUTCOME IMPROVEMENT RE-
SEARCH.
‘‘(a) EVIDENCE RATING SYSTEMS.—In collaboration
with experts from the public and private sector, the Agency
shall identify and disseminate methods or systems that it
uses to assess healthcare research results, particularly meth-
ods or systems that it uses to rate the strength of the sci-
entific evidence behind healthcare practice, recommenda-
tions in the research literature, and technology assessments.
The Agency shall make methods and systems for evidence
rating widely available. Agency publications containing
healthcare recommendations shall indicate the level of sub-
stantiating evidence using such methods or systems.
‘‘(b) HEALTHCARE IMPROVEMENT RESEARCH CEN-
TERS AND PROVIDER-BASED RESEARCH NETWORKS.—In
order to address the full continuum of care and outcomes
research, to link research to practice improvement, and to
speed the dissemination of research findings to community
practice settings, the Agency shall employ research strate-
gies and mechanisms that will link research directly with
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clinical practice in geographically diverse locations
throughout the United States, including—
‘‘(1) Healthcare Improvement Research Centers
that combine demonstrated multidisciplinary exper-
tise in outcomes or quality improvement research
with linkages to relevant sites of care;
‘‘(2) Provider-based Research Networks, includ-
ing plan, facility, or delivery system sites of care (es-
pecially primary care), that can evaluate and pro-
mote quality improvement; and
‘‘(3) other innovative mechanisms or strategies to
link research with clinical practice.
‘‘SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE
ORGANIZATION AND DELIVERY.
‘‘(a) SUPPORT FOR EFFORTS TO DEVELOP INFORMA-
TION ON QUALITY.—
‘‘(1) SCIENTIFIC AND TECHNICAL SUPPORT.—In
its role as the principal agency for healthcare research
and quality, the Agency may provide scientific and
technical support for private and public efforts to im-
prove healthcare quality, including the activities of
accrediting organizations.
‘‘(2) ROLE OF THE AGENCY.—With respect to
paragraph (1), the role of the Agency shall include—
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‘‘(A) the identification and assessment of
methods for the evaluation of the health of—
‘‘(i) enrollees in health plans by type of
plan, provider, and provider arrangements;
and
‘‘(ii) other populations, including those
receiving long-term care services;
‘‘(B) the ongoing development, testing, and
dissemination of quality measures, including
measures of health and functional outcomes;
‘‘(C) the compilation and dissemination of
healthcare quality measures developed in the pri-
vate and public sector;
‘‘(D) assistance in the development of im-
proved healthcare information systems;
‘‘(E) the development of survey tools for the
purpose of measuring participant and bene-
ficiary assessments of their healthcare; and
‘‘(F) identifying and disseminating infor-
mation on mechanisms for the integration of in-
formation on quality into purchaser and con-
sumer decision-making processes.
‘‘(b) CENTERS FOR EDUCATION AND RESEARCH ON
THERAPEUTICS.—
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‘‘(1) 
IN
GENERAL.—The 
Secretary, 
acting
through the Director and in consultation with the
Commissioner of Food and Drugs, shall establish a
program for the purpose of making one or more
grants for the establishment and operation of one or
more centers to carry out the activities specified in
paragraph (2).
‘‘(2) REQUIRED ACTIVITIES.—The activities re-
ferred to in this paragraph are the following:
‘‘(A) The conduct of state-of-the-art clinical,
laboratory, or health services research for the fol-
lowing purposes:
‘‘(i) To increase awareness of—
‘‘(I) new uses of drugs, biological
products, and devices;
‘‘(II) ways to improve the effective
use of drugs, biological products, and
devices; and
‘‘(III) risks of new uses and risks
of combinations of drugs and biological
products.
‘‘(ii) To provide objective clinical in-
formation to the following individuals and
entities:
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‘‘(I) Healthcare practitioners and
other providers of healthcare goods or
services.
‘‘(II) Pharmacists, pharmacy ben-
efit managers and purchasers.
‘‘(III) Health maintenance orga-
nizations 
and 
other 
managed
healthcare organizations.
‘‘(IV) Healthcare insurers and
governmental agencies.
‘‘(V) Patients and consumers.
‘‘(iii) To improve the quality of
healthcare while reducing the cost of
Healthcare through—
‘‘(I) an increase in the appro-
priate use of drugs, biological products,
or devices; and
‘‘(II) the prevention of adverse ef-
fects of drugs, biological products, and
devices and the consequences of such ef-
fects, such as unnecessary hospitaliza-
tions.
‘‘(B) The conduct of research on the com-
parative effectiveness, cost-effectiveness, and safe-
ty of drugs, biological products, and devices.
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‘‘(C) Such other activities as the Secretary
determines to be appropriate, except that grant
funds may not be used by the Secretary in con-
ducting regulatory review of new drugs.
‘‘(c) REDUCING ERRORS IN MEDICINE.—The Director
shall conduct and support research and build private-public
partnerships to—
‘‘(1) identify the causes of preventable healthcare
errors and patient injury in healthcare delivery;
‘‘(2) develop, demonstrate, and evaluate strate-
gies for reducing errors and improving patient safety;
and
‘‘(3) promote the implementation of effective
strategies throughout the healthcare industry.
‘‘SEC. 913. INFORMATION ON QUALITY AND COST OF CARE.
‘‘(a) IN GENERAL.—In carrying out 902(a), the Direc-
tor shall—
‘‘(1) conduct a survey to collect data on a na-
tionally representative sample of the population on
the cost, use and, for fiscal year 2001 and subsequent
fiscal years, quality of healthcare, including the types
of healthcare services Americans use, their access to
healthcare services, frequency of use, how much is
paid for the services used, the source of those pay-
ments, the types and costs of private health insurance,
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access, satisfaction, and quality of care for the general
population including rural residents and for the pop-
ulations identified in section 901(c); and
‘‘(2) develop databases and tools that provide in-
formation to States on the quality, access, and use of
healthcare services provided to their residents.
‘‘(b) QUALITY AND OUTCOMES INFORMATION.—
‘‘(1) IN
GENERAL.—Beginning in fiscal year
2001, the Director shall ensure that the survey con-
ducted under subsection (a)(1) will—
‘‘(A) identify determinants of health out-
comes and functional status, and their relation-
ships to healthcare access and use, determine the
ways and extent to which the priority popu-
lations enumerated in section 901(c) differ from
the general population with respect to such vari-
ables, measure changes over time with respect to
such variable, and monitor the overall national
impact of changes in Federal and State policy
on healthcare;
‘‘(B) provide information on the quality of
care and patient outcomes for frequently occur-
ring clinical conditions for a nationally rep-
resentative sample of the population including
rural residents; and
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‘‘(C) provide reliable national estimates for
children and persons with special healthcare
needs through the use of supplements or periodic
expansions of the survey.
In expanding the Medical Expenditure Panel Survey,
as in existence on the date of enactment of this title,
in fiscal year 2001 to collect information on the qual-
ity of care, the Director shall take into account any
outcomes measurements generally collected by private
sector accreditation organizations.
‘‘(2) ANNUAL REPORT.—Beginning in fiscal year
2003, the Secretary, acting through the Director, shall
submit to Congress an annual report on national
trends in the quality of healthcare provided to the
American people.
‘‘SEC. 914. INFORMATION SYSTEMS FOR HEALTHCARE IM-
PROVEMENT.
‘‘(a) IN GENERAL.—In order to foster a range of inno-
vative approaches to the management and communication
of health information, the Agency shall support research,
evaluations and initiatives to advance—
‘‘(1) the use of information systems for the study
of healthcare quality, including the generation of both
individual provider and plan-level comparative per-
formance data;
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‘‘(2) training for healthcare practitioners and re-
searchers in the use of information systems;
‘‘(3) the creation of effective linkages between
various sources of health information, including the
development of information networks;
‘‘(4) the delivery and coordination of evidence-
based healthcare services, including the use of real-
time healthcare decision-support programs;
‘‘(5) the utility and comparability of health in-
formation data and medical vocabularies by address-
ing issues related to the content, structure, definitions
and coding of such information and data in consulta-
tion with appropriate Federal, State and private en-
tities;
‘‘(6) the use of computer-based health records in
all settings for the development of personal health
records for individual health assessment and mainte-
nance, and for monitoring public health and outcomes
of care within populations; and
‘‘(7) the protection of individually identifiable
information in health services research and healthcare
quality improvement.
‘‘(b) DEMONSTRATION.—The Agency shall support
demonstrations into the use of new information tools aimed
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at improving shared decision-making between patients and
their care-givers.
‘‘SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND AC-
CESS IN UNDERSERVED AREAS.
‘‘(a) PREVENTIVE SERVICES TASK FORCE.—
‘‘(1) ESTABLISHMENT AND PURPOSE.—The Di-
rector may periodically convene a Preventive Services
Task Force to be composed of individuals with appro-
priate expertise. Such a task force shall review the
scientific evidence related to the effectiveness, appro-
priateness, and cost-effectiveness of clinical preventive
services for the purpose of developing recommenda-
tions for the healthcare community, and updating
previous clinical preventive recommendations.
‘‘(2) ROLE OF AGENCY.—The Agency shall pro-
vide ongoing administrative, research, and technical
support for the operations of the Preventive Services
Task Force, including coordinating and supporting
the dissemination of the recommendations of the Task
Force.
‘‘(3) OPERATION.—In carrying out its respon-
sibilities under paragraph (1), the Task Force is not
subject to the provisions of Appendix 2 of title 5,
United States Code.
‘‘(b) PRIMARY CARE RESEARCH.—
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‘‘(1) IN GENERAL.—There is established within
the Agency a Center for Primary Care Research (re-
ferred to in this subsection as the ‘Center’) that shall
serve as the principal source of funding for primary
care practice research in the Department of Health
and Human Services. For purposes of this paragraph,
primary care research focuses on the first contact
when illness or health concerns arise, the diagnosis,
treatment or referral to specialty care, preventive
care, and the relationship between the clinician and
the patient in the context of the family and commu-
nity.
‘‘(2) RESEARCH.—In carrying out this section,
the Center shall conduct and support research
concerning—
‘‘(A) the nature and characteristics of pri-
mary care practice;
‘‘(B) the management of commonly occur-
ring clinical problems;
‘‘(C) the management of undifferentiated
clinical problems; and
‘‘(D) the continuity and coordination of
health services.
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‘‘SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVA-
TION.
‘‘(a) IN GENERAL.—The Director shall promote inno-
vation in evidence-based clinical practice and healthcare
technologies by—
‘‘(1) conducting and supporting research on the
development, diffusion, and use of healthcare tech-
nology;
‘‘(2) developing, evaluating, and disseminating
methodologies for assessments of healthcare practices
and healthcare technologies;
‘‘(3) conducting intramural and supporting ex-
tramural assessments of existing and new healthcare
practices and technologies;
‘‘(4) promoting education, training, and pro-
viding technical assistance in the use of healthcare
practice and healthcare technology assessment meth-
odologies and results; and
‘‘(5) working with the National Library of Medi-
cine and the public and private sector to develop an
electronic clearinghouse of currently available assess-
ments and those in progress.
‘‘(b) SPECIFICATION OF PROCESS.—
‘‘(1) IN GENERAL.—Not later than December 31,
2000, the Director shall develop and publish a de-
scription of the methodology used by the Agency and
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its contractors in conducting practice and technology
assessment.
‘‘(2) CONSULTATIONS.—In carrying out this sub-
section, the Director shall cooperate and consult with
the Assistant Secretary for Health, the Administrator
of the Health Care Financing Administration, the Di-
rector of the National Institutes of Health, the Com-
missioner of Food and Drugs, and the heads of any
other interested Federal department or agency, and
shall seek input, where appropriate, from professional
societies and other private and public entities.
‘‘(3) METHODOLOGY.—The Director, in devel-
oping assessment methodology, shall consider—
‘‘(A) safety, efficacy, and effectiveness;
‘‘(B) legal, social, and ethical implications;
‘‘(C) costs, benefits, and cost-effectiveness;
‘‘(D) comparisons to alternate technologies
and practices; and
‘‘(E) requirements of Food and Drug Ad-
ministration approval to avoid duplication.
‘‘(c) SPECIFIC ASSESSMENTS.—
‘‘(1) IN GENERAL.—The Director shall conduct
or support specific assessments of healthcare tech-
nologies and practices.
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‘‘(2) REQUESTS FOR ASSESSMENTS.—The Direc-
tor is authorized to conduct or support assessments,
on a reimbursable basis, for the Health Care Financ-
ing Administration, the Department of Defense, the
Department of Veterans Affairs, the Office of Per-
sonnel Management, and other public or private enti-
ties.
‘‘(3) GRANTS AND CONTRACTS.—In addition to
conducting assessments, the Director may make
grants to, or enter into cooperative agreements or con-
tracts with, entities described in paragraph (4) for
the purpose of conducting assessments of experi-
mental, emerging, existing, or potentially outmoded
healthcare technologies, and for related activities.
‘‘(4) ELIGIBLE ENTITIES.—An entity described
in this paragraph is an entity that is determined to
be appropriate by the Director, including academic
medical centers, research institutions and organiza-
tions, professional organizations, third party payers,
governmental agencies, and consortia of appropriate
research entities established for the purpose of con-
ducting technology assessments.
‘‘SEC. 917. COORDINATION OF FEDERAL GOVERNMENT
QUALITY IMPROVEMENT EFFORTS.
‘‘(a) REQUIREMENT.—
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‘‘(1) IN GENERAL.—To avoid duplication and
ensure that Federal resources are used efficiently and
effectively, the Secretary, acting through the Director,
shall coordinate all research, evaluations, and dem-
onstrations related to health services research, quality
measurement and quality improvement activities un-
dertaken and supported by the Federal Government.
‘‘(2) SPECIFIC ACTIVITIES.—The Director, in col-
laboration with the appropriate Federal officials rep-
resenting all concerned executive agencies and depart-
ments, shall develop and manage a process to—
‘‘(A) improve interagency coordination, pri-
ority setting, and the use and sharing of research
findings and data pertaining to Federal quality
improvement programs, technology assessment,
and health services research;
‘‘(B) strengthen the research information
infrastructure, including databases, pertaining
to Federal health services research and healthcare
quality improvement initiatives;
‘‘(C) set specific goals for participating
agencies and departments to further health serv-
ices research and healthcare quality improve-
ment; and
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‘‘(D) strengthen the management of Federal
healthcare quality improvement programs.
‘‘(b) STUDY BY THE INSTITUTE OF MEDICINE.—
‘‘(1) IN GENERAL.—To provide Congress, the De-
partment of Health and Human Services, and other
relevant departments with an independent, external
review of their quality oversight, quality improvement
and quality research programs, the Secretary shall
enter into a contract with the Institute of Medicine—
‘‘(A) to describe and evaluate current qual-
ity improvement, quality research and quality
monitoring processes through—
‘‘(i) an overview of pertinent health
services research activities and quality im-
provement efforts conducted by all Federal
programs, with particular attention paid to
those under titles XVIII, XIX, and XXI of
the Social Security Act; and
‘‘(ii) a summary of the partnerships
that the Department of Health and Human
Services has pursued with private accredi-
tation, quality measurement and improve-
ment organizations; and
‘‘(B) to identify options and make rec-
ommendations to improve the efficiency and ef-
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fectiveness of quality improvement programs
through—
‘‘(i) the improved coordination of ac-
tivities across the medicare, medicaid and
child health insurance programs under titles
XVIII, XIX and XXI of the Social Security
Act and health services research programs;
‘‘(ii) the strengthening of patient choice
and participation by incorporating state-of-
the-art quality monitoring tools and mak-
ing information on quality available; and
‘‘(iii) the enhancement of the most ef-
fective programs, consolidation as appro-
priate, and elimination of duplicative ac-
tivities within various federal agencies.
‘‘(2) REQUIREMENTS.—
‘‘(A) IN
GENERAL.—The Secretary shall
enter into a contract with the Institute of Medi-
cine for the preparation—
‘‘(i) not later than 12 months after the
date of enactment of this title, of a report
providing an overview of the quality im-
provement programs of the Department of
Health and Human Services for the medi-
care, medicaid, and CHIP programs under
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titles XVIII, XIX, and XXI of the Social Se-
curity Act; and
‘‘(ii) not later than 24 months after the
date of enactment of this title, of a final re-
port containing recommendations.
‘‘(B) REPORTS.—The Secretary shall sub-
mit the reports described in subparagraph (A) to
the Committee on Finance and the Committee on
Health, Education, Labor, and Pensions of the
Senate and the Committee on Ways and Means
and the Committee on Commerce of the House of
Representatives.
‘‘PART C—GENERAL PROVISIONS
‘‘SEC. 921. ADVISORY COUNCIL FOR HEALTHCARE RE-
SEARCH AND QUALITY.
‘‘(a) ESTABLISHMENT.—There is established an advi-
sory council to be known as the Advisory Council for
Healthcare Research and Quality.
‘‘(b) DUTIES.—
‘‘(1) IN GENERAL.—The Advisory Council shall
advise the Secretary and the Director with respect to
activities proposed or undertaken to carry out the
purpose of the Agency under section 901(b).
‘‘(2) CERTAIN RECOMMENDATIONS.—Activities of
the Advisory Council under paragraph (1) shall in-
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clude making recommendations to the Director
regarding—
‘‘(A) priorities regarding healthcare re-
search, especially studies related to quality, out-
comes, cost and the utilization of, and access to,
healthcare services;
‘‘(B) the field of healthcare research and re-
lated disciplines, especially issues related to
training needs, and dissemination of informa-
tion pertaining to healthcare quality; and
‘‘(C) the appropriate role of the Agency in
each of these areas in light of private sector ac-
tivity and identification of opportunities for
public-private sector partnerships.
‘‘(c) MEMBERSHIP.—
‘‘(1) IN GENERAL.—The Advisory Council shall,
in accordance with this subsection, be composed of ap-
pointed members and ex officio members. All members
of the Advisory Council shall be voting members other
than the individuals designated under paragraph
(3)(B) as ex officio members.
‘‘(2) APPOINTED MEMBERS.—The Secretary shall
appoint to the Advisory Council 21 appropriately
qualified individuals. At least 17 members of the Ad-
visory Council shall be representatives of the public
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who are not officers or employees of the United States.
The Secretary shall ensure that the appointed mem-
bers of the Council, as a group, are representative of
professions and entities concerned with, or affected by,
activities under this title and under section 1142 of
the Social Security Act. Of such members—
‘‘(A) 4 shall be individuals distinguished in
the conduct of research, demonstration projects,
and evaluations with respect to healthcare;
‘‘(B) 4 shall be individuals distinguished in
the practice of medicine of which at least 1 shall
be a primary care practitioner;
‘‘(C) 3 shall be individuals distinguished in
the other health professions;
‘‘(D) 4 shall be individuals either rep-
resenting the private healthcare sector, including
health plans, providers, and purchasers or indi-
viduals 
distinguished 
as 
administrators 
of
healthcare delivery systems;
‘‘(E) 4 shall be individuals distinguished in
the fields of healthcare quality improvement, eco-
nomics, information systems, law, ethics, busi-
ness, or public policy, including at least 1 indi-
vidual specializing in rural aspects in 1 or more
of these fields; and
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‘‘(F) 2 shall be individuals representing the
interests of patients and consumers of healthcare.
‘‘(3) EX OFFICIO MEMBERS.—The Secretary shall
designate as ex officio members of the Advisory
Council—
‘‘(A) the Assistant Secretary for Health, the
Director of the National Institutes of Health, the
Director of the Centers for Disease Control and
Prevention, the Administrator of the Health Care
Financing Administration, the Assistant Sec-
retary of Defense (Health Affairs), and the
Under Secretary for Health of the Department of
Veterans Affairs; and
‘‘(B) such other Federal officials as the Sec-
retary may consider appropriate.
‘‘(d) TERMS.—Members of the Advisory Council ap-
pointed under subsection (c)(2) shall serve for a term of 3
years. A member of the Council appointed under such sub-
section may continue to serve after the expiration of the
term of the members until a successor is appointed.
‘‘(e) VACANCIES.—If a member of the Advisory Council
appointed under subsection (c)(2) does not serve the full
term applicable under subsection (d), the individual ap-
pointed to fill the resulting vacancy shall be appointed for
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the remainder of the term of the predecessor of the indi-
vidual.
‘‘(f) CHAIR.—The Director shall, from among the
members of the Advisory Council appointed under sub-
section (c)(2), designate an individual to serve as the chair
of the Advisory Council.
‘‘(g) MEETINGS.—The Advisory Council shall meet not
less than once during each discrete 4-month period and
shall otherwise meet at the call of the Director or the chair.
‘‘(h) COMPENSATION AND REIMBURSEMENT OF EX-
PENSES.—
‘‘(1) APPOINTED MEMBERS.—Members of the Ad-
visory Council appointed under subsection (c)(2) shall
receive compensation for each day (including travel
time) engaged in carrying out the duties of the Advi-
sory Council unless declined by the member. Such
compensation may not be in an amount in excess of
the daily equivalent of the annual rate of basic pay
prescribed for level IV of the Executive Schedule
under section 5315 of title 5, United States Code, for
each day during which such member is engaged in the
performance of the duties of the Advisory Council.
‘‘(2) EX
OFFICIO
MEMBERS.—Officials des-
ignated under subsection (c)(3) as ex officio members
of the Advisory Council may not receive compensation
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for service on the Advisory Council in addition to the
compensation otherwise received for duties carried out
as officers of the United States.
‘‘(i) STAFF.—The Director shall provide to the Advi-
sory Council such staff, information, and other assistance
as may be necessary to carry out the duties of the Council.
‘‘SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND
CONTRACTS.
‘‘(a) REQUIREMENT OF REVIEW.—
‘‘(1) IN GENERAL.—Appropriate technical and
scientific peer review shall be conducted with respect
to each application for a grant, cooperative agree-
ment, or contract under this title.
‘‘(2) REPORTS TO DIRECTOR.—Each peer review
group to which an application is submitted pursuant
to paragraph (1) shall report its finding and rec-
ommendations respecting the application to the Direc-
tor in such form and in such manner as the Director
shall require.
‘‘(b) APPROVAL AS PRECONDITION OF AWARDS.—The
Director may not approve an application described in sub-
section (a)(1) unless the application is recommended for ap-
proval by a peer review group established under subsection
(c).
‘‘(c) ESTABLISHMENT OF PEER REVIEW GROUPS.—
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‘‘(1) IN GENERAL.—The Director shall establish
such technical and scientific peer review groups as
may be necessary to carry out this section. Such
groups shall be established without regard to the pro-
visions of title 5, United States Code, that govern ap-
pointments in the competitive service, and without re-
gard to the provisions of chapter 51, and subchapter
III of chapter 53, of such title that relate to classifica-
tion and pay rates under the General Schedule.
‘‘(2) MEMBERSHIP.—The members of any peer
review group established under this section shall be
appointed from among individuals who by virtue of
their training or experience are eminently qualified
to carry out the duties of such peer review group. Of-
ficers and employees of the United States may not
constitute more than 25 percent of the membership of
any such group. Such officers and employees may not
receive compensation for service on such groups in ad-
dition to the compensation otherwise received for these
duties carried out as such officers and employees.
‘‘(3) DURATION.—Notwithstanding section 14(a)
of the Federal Advisory Committee Act, peer review
groups established under this section may continue in
existence until otherwise provided by law.
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‘‘(4) QUALIFICATIONS.—Members of any peer-re-
view group shall, at a minimum, meet the following
requirements:
‘‘(A) Such members shall agree in writing
to treat information received, pursuant to their
work for the group, as confidential information,
except that this subparagraph shall not apply to
public records and public information.
‘‘(B) Such members shall agree in writing
to recuse themselves from participation in the
peer-review of specific applications which present
a potential personal conflict of interest or ap-
pearance of such conflict, including employment
in a directly affected organization, stock owner-
ship, or any financial or other arrangement that
might introduce bias in the process of peer-re-
view.
‘‘(d) AUTHORITY FOR PROCEDURAL ADJUSTMENTS IN
CERTAIN CASES.—In the case of applications for financial
assistance whose direct costs will not exceed $100,000, the
Director may make appropriate adjustments in the proce-
dures otherwise established by the Director for the conduct
of peer review under this section. Such adjustments may
be made for the purpose of encouraging the entry of individ-
uals into the field of research, for the purpose of encour-
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aging clinical practice-oriented or provider-based research,
and for such other purposes as the Director may determine
to be appropriate.
‘‘(e) REGULATIONS.—The Director shall issue regula-
tions for the conduct of peer review under this section.
‘‘SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVEL-
OPMENT, COLLECTION, AND DISSEMINATION
OF DATA.
‘‘(a) STANDARDS WITH RESPECT
TO UTILITY
OF
DATA.—
‘‘(1) IN GENERAL.—To ensure the utility, accu-
racy, and sufficiency of data collected by or for the
Agency for the purpose described in section 901(b),
the Director shall establish standard methods for de-
veloping and collecting such data, taking into
consideration—
‘‘(A) other Federal health data collection
standards; and
‘‘(B) the differences between types of
healthcare plans, delivery systems, healthcare
providers, and provider arrangements.
‘‘(2) RELATIONSHIP WITH OTHER DEPARTMENT
PROGRAMS.—In any case where standards under
paragraph (1) may affect the administration of other
programs carried out by the Department of Health
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and Human Services, including the programs under
title XVIII, XIX or XXI of the Social Security Act,
or may affect health information that is subject to a
standard developed under part C of title XI of the So-
cial Security Act, they shall be in the form of rec-
ommendations to the Secretary for such program.
‘‘(b) STATISTICS
AND
ANALYSES.—The Director
shall—
‘‘(1) take appropriate action to ensure that sta-
tistics and analyses developed under this title are of
high quality, timely, and duly comprehensive, and
that the statistics are specific, standardized, and ade-
quately analyzed and indexed; and
‘‘(2) publish, make available, and disseminate
such statistics and analyses on as wide a basis as is
practicable.
‘‘(c) AUTHORITY REGARDING CERTAIN REQUESTS.—
Upon request of a public or private entity, the Director may
conduct or support research or analyses otherwise author-
ized by this title pursuant to arrangements under which
such entity will pay the cost of the services provided.
Amounts received by the Director under such arrangements
shall be available to the Director for obligation until ex-
pended.
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‘‘SEC. 924. DISSEMINATION OF INFORMATION.
‘‘(a) IN GENERAL.—The Director shall—
‘‘(1) without regard to section 501 of title 44,
United States Code, promptly publish, make avail-
able, and otherwise disseminate, in a form under-
standable and on as broad a basis as practicable so
as to maximize its use, the results of research, dem-
onstration projects, and evaluations conducted or sup-
ported under this title;
‘‘(2) ensure that information disseminated by the
Agency is science-based and objective and undertakes
consultation as necessary to assess the appropriate-
ness and usefulness of the presentation of information
that is targeted to specific audiences;
‘‘(3) promptly make available to the public data
developed in such research, demonstration projects,
and evaluations;
‘‘(4) provide, in collaboration with the National
Library of Medicine where appropriate, indexing, ab-
stracting, translating, publishing, and other services
leading to a more effective and timely dissemination
of information on research, demonstration projects,
and evaluations with respect to healthcare to public
and private entities and individuals engaged in the
improvement of healthcare delivery and the general
public, and undertake programs to develop new or
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improved methods for making such information avail-
able; and
‘‘(5) as appropriate, provide technical assistance
to State and local government and health agencies
and conduct liaison activities to such agencies to fos-
ter dissemination.
‘‘(b) PROHIBITION AGAINST RESTRICTIONS.—Except
as provided in subsection (c), the Director may not restrict
the publication or dissemination of data from, or the results
of, projects conducted or supported under this title.
‘‘(c) LIMITATION
ON USE
OF CERTAIN INFORMA-
TION.—No information, if an establishment or person sup-
plying the information or described in it is identifiable, ob-
tained in the course of activities undertaken or supported
under this title may be used for any purpose other than
the purpose for which it was supplied unless such establish-
ment or person has consented (as determined under regula-
tions of the Director) to its use for such other purpose. Such
information may not be published or released in other form
if the person who supplied the information or who is de-
scribed in it is identifiable unless such person has consented
(as determined under regulations of the Director) to its pub-
lication or release in other form.
‘‘(d) PENALTY.—Any person who violates subsection
(c) shall be subject to a civil monetary penalty of not more
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than $10,000 for each such violation involved. Such penalty
shall be imposed and collected in the same manner as civil
money penalties under subsection (a) of section 1128A of
the Social Security Act are imposed and collected.
‘‘SEC. 925. ADDITIONAL PROVISIONS WITH RESPECT TO
GRANTS AND CONTRACTS.
‘‘(a) FINANCIAL CONFLICTS OF INTEREST.—With re-
spect to projects for which awards of grants, cooperative
agreements, or contracts are authorized to be made under
this title, the Director shall by regulation define—
‘‘(1) the specific circumstances that constitute fi-
nancial interests in such projects that will, or may be
reasonably expected to, create a bias in favor of ob-
taining results in the projects that are consistent with
such interests; and
‘‘(2) the actions that will be taken by the Direc-
tor in response to any such interests identified by the
Director.
‘‘(b) REQUIREMENT OF APPLICATION.—The Director
may not, with respect to any program under this title au-
thorizing the provision of grants, cooperative agreements,
or contracts, provide any such financial assistance unless
an application for the assistance is submitted to the Sec-
retary and the application is in such form, is made in such
manner, and contains such agreements, assurances, and in-
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formation as the Director determines to be necessary to
carry out the program in involved.
‘‘(c) PROVISION OF SUPPLIES AND SERVICES IN LIEU
OF FUNDS.—
‘‘(1) IN GENERAL.—Upon the request of an enti-
ty receiving a grant, cooperative agreement, or con-
tract under this title, the Secretary may, subject to
paragraph (2), provide supplies, equipment, and serv-
ices for the purpose of aiding the entity in carrying
out the project involved and, for such purpose, may
detail to the entity any officer or employee of the De-
partment of Health and Human Services.
‘‘(2) CORRESPONDING REDUCTION IN FUNDS.—
With respect to a request described in paragraph (1),
the Secretary shall reduce the amount of the financial
assistance involved by an amount equal to the costs
of detailing personnel and the fair market value of
any supplies, equipment, or services provided by the
Director. The Secretary shall, for the payment of ex-
penses incurred in complying with such request, ex-
pend the amounts withheld.
‘‘(d) APPLICABILITY OF CERTAIN PROVISIONS WITH
RESPECT TO CONTRACTS.—Contracts may be entered into
under this part without regard to sections 3648 and 3709
of the Revised Statutes (31 U.S.C. 529; 41 U.S.C. 5).
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‘‘SEC. 926. CERTAIN ADMINISTRATIVE AUTHORITIES.
‘‘(a) DEPUTY DIRECTOR AND OTHER OFFICERS AND
EMPLOYEES.—
‘‘(1) DEPUTY DIRECTOR.—The Director may ap-
point a deputy director for the Agency.
‘‘(2) OTHER OFFICERS AND EMPLOYEES.—The
Director may appoint and fix the compensation of
such officers and employees as may be necessary to
carry out this title. Except as otherwise provided by
law, such officers and employees shall be appointed in
accordance with the civil service laws and their com-
pensation fixed in accordance with title 5, United
States Code.
‘‘(b) FACILITIES.—The Secretary, in carrying out this
title—
‘‘(1) may acquire, without regard to the Act of
March 3, 1877 (40 U.S.C. 34), by lease or otherwise
through the Director of General Services, buildings or
portions of buildings in the District of Columbia or
communities located adjacent to the District of Co-
lumbia for use for a period not to exceed 10 years;
and
‘‘(2) may acquire, construct, improve, repair, op-
erate, and maintain laboratory, research, and other
necessary facilities and equipment, and such other
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real or personal property (including patents) as the
Secretary deems necessary.
‘‘(c) PROVISION OF FINANCIAL ASSISTANCE.—The Di-
rector, in carrying out this title, may make grants to public
and nonprofit entities and individuals, and may enter into
cooperative agreements or contracts with public and private
entities and individuals.
‘‘(d) UTILIZATION OF CERTAIN PERSONNEL AND RE-
SOURCES.—
‘‘(1) DEPARTMENT
OF
HEALTH
AND
HUMAN
SERVICES.—The Director, in carrying out this title,
may utilize personnel and equipment, facilities, and
other physical resources of the Department of Health
and Human Services, permit appropriate (as deter-
mined by the Secretary) entities and individuals to
utilize the physical resources of such Department, and
provide technical assistance and advice.
‘‘(2) OTHER AGENCIES.—The Director, in car-
rying out this title, may use, with their consent, the
services, equipment, personnel, information, and fa-
cilities of other Federal, State, or local public agen-
cies, or of any foreign government, with or without
reimbursement of such agencies.
‘‘(e) CONSULTANTS.—The Secretary, in carrying out
this title, may secure, from time to time and for such peri-
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ods as the Director deems advisable but in accordance with
section 3109 of title 5, United States Code, the assistance
and advice of consultants from the United States or abroad.
‘‘(f) EXPERTS.—
‘‘(1) IN GENERAL.—The Secretary may, in car-
rying out this title, obtain the services of not more
than 50 experts or consultants who have appropriate
scientific or professional qualifications. Such experts
or consultants shall be obtained in accordance with
section 3109 of title 5, United States Code, except that
the limitation in such section on the duration of serv-
ice shall not apply.
‘‘(2) TRAVEL EXPENSES.—
‘‘(A) IN
GENERAL.—Experts and consult-
ants whose services are obtained under para-
graph (1) shall be paid or reimbursed for their
expenses associated with traveling to and from
their assignment location in accordance with sec-
tions 5724, 5724a(a), 5724a(c), and 5726(C) of
title 5, United States Code.
‘‘(B) LIMITATION.—Expenses specified in
subparagraph (A) may not be allowed in connec-
tion with the assignment of an expert or consult-
ant whose services are obtained under paragraph
(1) unless and until the expert agrees in writing
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to complete the entire period of assignment, or 1
year, whichever is shorter, unless separated or re-
assigned for reasons that are beyond the control
of the expert or consultant and that are accept-
able to the Secretary. If the expert or consultant
violates the agreement, the money spent by the
United States for the expenses specified in sub-
paragraph (A) is recoverable from the expert or
consultant as a statutory obligation owed to the
United States. The Secretary may waive in
whole or in part a right of recovery under this
subparagraph.
‘‘(g) VOLUNTARY AND UNCOMPENSATED SERVICES.—
The Director, in carrying out this title, may accept vol-
untary and uncompensated services.
‘‘SEC. 927. FUNDING.
‘‘(a) INTENT.—To ensure that the United States’s in-
vestment in biomedical research is rapidly translated into
improvements in the quality of patient care, there must be
a corresponding investment in research on the most effective
clinical and organizational strategies for use of these find-
ings in daily practice. The authorization levels in sub-
section (b) provide for a proportionate increase in
healthcare research as the United States investment in bio-
medical research increases.
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‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this title, there are authorized to
be appropriated $250,000,000 for fiscal year 2000, and such
sums as may be necessary for each of the fiscal years 2001
through 2006.
‘‘(c) EVALUATIONS.—In addition to amounts available
pursuant to subsection (b) for carrying out this title, there
shall be made available for such purpose, from the amounts
made available pursuant to section 241 (relating to evalua-
tions), an amount equal to 40 percent of the maximum
amount authorized in such section 241 to be made available
for a fiscal year.
‘‘SEC. 928. DEFINITIONS.
‘‘In this title:
‘‘(1) ADVISORY
COUNCIL.—The term ‘Advisory
Council’ means the Advisory Council on Healthcare
Research and Quality established under section 921.
‘‘(2) AGENCY.—The term ‘Agency’ means the
Agency for Healthcare Research and Quality.
‘‘(3) DIRECTOR.—The term ‘Director’ means the
Director for the Agency for Healthcare Research and
Quality.’’.
SEC. 403. REFERENCES.
Effective upon the date of enactment of this Act, any
reference in law to the ‘‘Agency for Health Care Policy and
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Research’’ shall be deemed to be a reference to the ‘‘Agency
for Healthcare Research and Quality’’.
TITLE V—ENHANCED ACCESS TO
HEALTH INSURANCE COVERAGE
SEC. 501. FULL DEDUCTION OF HEALTH INSURANCE COSTS
FOR SELF-EMPLOYED INDIVIDUALS.
(a) IN GENERAL.—Section 162(l)(1) of the Internal
Revenue Code of 1986 (relating to allowance of deductions)
is amended to read as follows:
‘‘(1) ALLOWANCE OF DEDUCTION.—In the case of
an individual who is an employee within the mean-
ing of section 401(c)(1), there shall be allowed as a
deduction under this section an amount equal to the
amount paid during the taxable year for insurance
which constitutes medical care for the taxpayer, his
spouse, and his dependents.’’.
(b) EFFECTIVE DATE.—The amendments made by this
section shall apply to taxable years beginning after Decem-
ber 31, 1999.
SEC. 502. FULL AVAILABILITY OF MEDICAL SAVINGS AC-
COUNTS.
(a) AVAILABILITY NOT LIMITED TO ACCOUNTS FOR
EMPLOYEES OF SMALL EMPLOYERS AND SELF-EMPLOYED
INDIVIDUALS.—
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(1) IN GENERAL.—Section 220(c)(1)(A) of the
Internal Revenue Code of 1986 (relating to eligible in-
dividual) is amended to read as follows:
‘‘(A) IN GENERAL.—The term ‘eligible indi-
vidual’ means, with respect to any month, any
individual if—
‘‘(i) such individual is covered under a
high deductible health plan as of the 1st day
of such month, and
‘‘(ii) such individual is not, while cov-
ered under a high deductible health plan,
covered under any health plan—
‘‘(I) which is not a high deduct-
ible health plan, and
‘‘(II) which provides coverage for
any benefit which is covered under the
high deductible health plan.’’.
(2) CONFORMING AMENDMENTS.—
(A) Section 220(c)(1) of such Code is
amended by striking subparagraphs (C) and (D).
(B) Section 220(c) of such Code is amended
by striking paragraph (4) (defining small em-
ployer) and by redesignating paragraph (5) as
paragraph (4).
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(C) Section 220(b) of such Code is amended
by striking paragraph (4) (relating to deduction
limited by compensation) and by redesignating
paragraphs (5), (6), and (7) as paragraphs (4),
(5), and (6), respectively.
(b) REMOVAL OF LIMITATION ON NUMBER OF TAX-
PAYERS HAVING MEDICAL SAVINGS ACCOUNTS.—
(1) IN GENERAL.—Section 220 of the Internal
Revenue Code of 1986 (relating to medical savings ac-
counts) is amended by striking subsections (i) and (j).
(2) MEDICARE+CHOICE.—Section 138 of such
Code (relating to Medicare+Choice MSA) is amended
by striking subsection (f).
(c) REDUCTION IN HIGH DEDUCTIBLE PLAN MINIMUM
ANNUAL DEDUCTIBLE.—
(1) IN GENERAL.—Subparagraph (A) of section
220(c)(2) of such Code (defining high deductible
health plan) is amended—
(A) by striking ‘‘$1,500’’ and inserting
‘‘$1,000’’, and
(B) by striking ‘‘$3,000’’ in clause (ii) and
inserting ‘‘$2,000’’.
(2) CONFORMING
AMENDMENT.—Subsection (g)
of section 220 of such Code is amended—
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(A) by striking ‘‘1998’’ and inserting
‘‘1999’’; and
(B) by striking ‘‘1997’’ and inserting
‘‘1998’’.
(d) INCREASE IN CONTRIBUTION LIMIT TO 100 PER-
CENT OF ANNUAL DEDUCTIBLE.—
(1) IN GENERAL.—Section 220(b)(2) of the Inter-
nal Revenue Code of 1986 (relating to monthly limi-
tation) is amended to read as follows:
‘‘(2) MONTHLY LIMITATION.—The monthly limi-
tation for any month is the amount equal to 1⁄12 of
the annual deductible of the high deductible health
plan of the individual.’’.
(2) 
CONFORMING
AMENDMENT.—Section
220(d)(1)(A) of such Code is amended by striking ‘‘75
percent of’’.
(e) LIMITATION ON ADDITIONAL TAX ON DISTRIBU-
TIONS NOT USED FOR QUALIFIED MEDICAL EXPENSES.—
Section 220(f)(4) of the Internal Revenue Code of 1986 (re-
lating to additional tax on distributions not used for quali-
fied medical expenses) is amended by adding at the end the
following:
‘‘(D) EXCEPTION IN CASE OF SUFFICIENT
ACCOUNT
BALANCE.—Subparagraph (A) shall
not apply to any payment or distribution in
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any taxable year, but only to the extent such
payment or distribution does not reduce the fair
market value of the assets of the medical savings
account to an amount less than the annual de-
ductible for the high deductible health plan of the
account holder (determined as of January 1 of
the calendar year in which the taxable year be-
gins).’’.
(f) TREATMENT OF NETWORK-BASED MANAGED CARE
PLANS.—Section 220(c)(2)(B) of the Internal Revenue Code
of 1986 (relating to special rules for high deductible health
plans) is amended by adding at the end the following:
‘‘(iii) TREATMENT OF NETWORK-BASED
MANAGED CARE PLANS.—A plan that pro-
vides health care services through a network
of contracted or affiliated health care pro-
viders, if the benefits provided when services
are obtained through network providers
meet the requirements of subparagraph (A),
shall not fail to be treated as a high deduct-
ible health plan by reason of providing ben-
efits for services rendered by providers who
are not members of the network, so long as
the annual deductible and annual limit on
out-of-pocket expenses applicable to services