Calendar No. 160
To improve the access and choice of patients to quality, affordable health care.
S 326 RS
Mr. JEFFORDS (for himself, Mr. FRIST, Mr. DEWINE, Mr. ENZI, Mr. HUTCHINSON, Ms. COLLINS, Mr. BROWNBACK, Mr. HAGEL, Mr. SESSIONS, Mr. BURNS, and Mr. GREGG) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
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(a) SHORT TITLE- This Act may be cited as the
`Patients' Bill of Rights Act'.
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(b) TABLE OF CONTENTS- The table of contents for
this Act is as follows:
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Sec. 1. Short title; table of contents.
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TITLE I--PATIENTS' BILL OF RIGHTS
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Subtitle A--Right to Advice and Care
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Sec. 101. Patient right to medical advice and
care.
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`SUBPART C--PATIENT RIGHT TO MEDICAL ADVICE AND CARE
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`Sec. 721. Patient access to emergency medical
care.
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`Sec. 722. Offering of choice of coverage
options.
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`Sec. 723. Patient access to obstetric and
gynecological care.
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`Sec. 724. Patient access to pediatric care.
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`Sec. 725. Continuity of care.
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`Sec. 726. Protection of patient-provider
communications.
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`Sec. 727. Generally applicable provision.'
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Sec. 102. Effective date and related rules.
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Subtitle B--Right to Information About Plans and
Providers
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Sec. 111. Information about plans.
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Sec. 112. Information about providers.
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Subtitle C--Right to Hold Health Plans Accountable
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Sec. 121. Amendment to Employee Retirement
Income Security Act of 1974.
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TITLE II--INDIVIDUAL RIGHTS WITH RESPECT TO PERSONAL
MEDICAL INFORMATION
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Sec. 201. Short title.
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Subtitle A--Access to Medical Records
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Sec. 211. Inspection and copying of protected
health information.
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Sec. 212. Amendment of protected health
information.
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Sec. 213. Notice of confidentiality practices.
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Subtitle B--Establishment of Safeguards
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Sec. 221. Establishment of safeguards.
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Subtitle C--Enforcement; Definitions
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Sec. 231. Civil penalty.
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Sec. 232. Definitions.
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Sec. 233. Effective date.
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TITLE III--GENETIC INFORMATION AND SERVICES
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Sec. 301. Short title.
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Sec. 302. Amendments to Employee Retirement
Income Security Act of 1974.
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Sec. 303. Amendments to the Public Health
Service Act.
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TITLE IV--HEALTHCARE RESEARCH AND QUALITY
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Sec. 401. Short title.
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Sec. 402. Amendment to the Public Health Service
Act.
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`TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND
QUALITY
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`Part A--Establishment and General Duties
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`Sec. 901. Mission and duties.
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`Sec. 902. General authorities.
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`Part B--Healthcare Improvement Research
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`Sec. 911. Healthcare outcome improvement
research.
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`Sec. 912. Private-public partnerships to
improve organization and delivery.
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`Sec. 913. Information on quality and cost of
care.
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`Sec. 914. Information systems for healthcare
improvement.
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`Sec. 915. Research supporting primary care and
access in underserved areas.
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`Sec. 916. Clinical practice and technology
innovation.
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`Sec. 917. Coordination of Federal Government
quality improvement efforts.
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`Part C--General Provisions
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`Sec. 921. Advisory Council for Healthcare
Research and Quality.
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`Sec. 922. Peer review with respect to grants
and contracts.
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`Sec. 923. Certain provisions with respect to
development, collection, and dissemination of data.
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`Sec. 924. Dissemination of information.
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`Sec. 925. Additional provisions with respect to
grants and contracts.
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`Sec. 926. Certain administrative authorities.
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`Sec. 927. Funding.
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`Sec. 928. Definitions.'
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Sec. 403. References.
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Sec. 404. Study.
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TITLE V--MISCELLANEOUS PROVISIONS
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Sec. 501. Sense of the Committee.
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TITLE I--PATIENTS' BILL OF RIGHTS
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Subtitle A--Right to Advice and Care
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SEC. 101. PATIENT RIGHT TO MEDICAL ADVICE AND CARE.
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(a) IN GENERAL- Part 7 of subtitle B of title I of
the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 et seq.)
is amended--
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(1) by redesignating subpart C as subpart D; and
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(2) by inserting after subpart B the following:
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`Subpart C--Patient Right to Medical Advice and
Care
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`SEC. 721. PATIENT ACCESS TO EMERGENCY MEDICAL CARE.
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`(a) IN GENERAL- To the extent that the group
health plan (other than a fully insured group health plan) provides coverage
for benefits consisting of
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(c)), except for items or services specifically excluded--
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`(1) the plan shall provide coverage for
benefits, without requiring preauthorization, for appropriate emergency
medical screening examinations (within the capability of the emergency
facility, including ancillary services routinely available to the emergency
facility) to the extent that a prudent layperson, who possesses an average
knowledge of health and medicine, would determine such examinations to be
necessary to determine whether emergency medical care (as so defined) is
necessary, and
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`(2) the plan shall provide coverage for
benefits for additional emergency medical care to stabilize an emergency
medical condition following an emergency medical screening examination (if
determined necessary under paragraph (1)), pursuant to the definition of
stabilize under section 1867(e)(3) of the Social Security Act (42 U.S.C.
1395dd(e)(3)).
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`(b) UNIFORM COST-SHARING REQUIRED- Nothing in
this section shall be construed as preventing a group health plan (other than
a fully insured group health plan) from imposing any form of cost-sharing
applicable to any participant or beneficiary (including coinsurance,
copayments, deductibles, and any other charges) in relation to coverage 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 emergency
medical care (as defined in subsection (c)) provided to such similarly
situated participants and beneficiaries under the plan.
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`(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 beneficiary under a group
health plan (other than a fully insured group health plan), covered
inpatient and outpatient services that--
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`(A) are furnished by any provider, including
a nonparticipating provider, that is qualified to furnish such services;
and
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`(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)) an emergency medical condition (as defined in paragraph
(2)).
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`(2) EMERGENCY MEDICAL CONDITION- The term
`emergency medical condition' means a medical condition manifesting itself
by acute symptoms of sufficient severity (including severe pain) such that a
prudent layperson, who possesses an average knowledge of health and
medicine, could reasonably expect the absence of immediate medical attention
to result in--
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`(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 functions,
or
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`(C) serious dysfunction of any bodily organ
or part.
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`SEC. 722. OFFERING OF CHOICE OF COVERAGE OPTIONS.
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`(a) REQUIREMENT-
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`(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 professionals, the plan
shall offer the participant the option to purchase point-of-service coverage
(as defined in subsection (b)) for all such benefits for which coverage is
otherwise so limited. Such option shall be made available to the participant
at the time of enrollment under the plan and at such other times as the plan
offers the participant a choice of coverage options.
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`(2) EXCEPTION IN THE CASE OF MULTIPLE ISSUER OR
COVERAGE OPTIONS- Paragraph (1) shall not apply with respect to a
participant in a group health plan (other than a fully insured group health
plan) if the plan offers the participant--
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`(A) a choice of health insurance coverage
through more than one health insurance issuer; or
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`(B) two or more coverage options that differ
significantly with respect to the use of participating health care
professionals or the networks of such professionals that are used.
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`(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.
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`(c) SMALL EMPLOYER EXEMPTION-
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`(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.
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`(2) SMALL EMPLOYER- For purposes of paragraph
(1), the term `small employer' means, in connection 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
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section 712(c)(1) shall apply in determining employer size.
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`(d) RULE OF CONSTRUCTION- Nothing in this section
shall be construed--
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`(1) as requiring coverage for benefits for a
particular type of health care professional;
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`(2) as requiring an employer to pay any costs
as a result of this section or to make equal contributions with respect to
different health coverage options;
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`(3) as preventing a group health plan (other
than a fully insured group health plan) from imposing higher premiums or
cost-sharing on a participant for the exercise of a point-of-service
coverage option; or
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`(4) to require that a group health plan (other
than a fully insured group health plan) include coverage of health care
professionals that the plan excludes because of fraud, quality of care, or
other similar reasons with respect to such professionals.
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`SEC. 723. PATIENT ACCESS TO OBSTETRIC AND
GYNECOLOGICAL CARE.
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`(a) IN GENERAL- In any case in which a group
health plan (other than a fully insured group health plan)--
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`(1) provides coverage for benefits consisting
of--
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`(A) gynecological care (such as preventive
women's health examinations); or
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`(B) obstetric care (such as pregnancy-related
services);
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provided by a participating physician who
specializes in such care; and
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`(2) requires or provides for designation by a
participant or beneficiary of a participating primary care provider;
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if the primary care provider designated by such a
participant or beneficiary is not such a physician as described in paragraph
(1), then the plan shall meet the requirements of subsection (b).
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`(b) REQUIREMENTS- A group health plan (other than
a fully insured group health plan) meets the requirements of this subsection,
in connection with the coverage of benefits described in subsection (a)
consisting of care described in subparagraph (A) or (B) of subsection (a)(1),
if the plan--
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`(1) does not require authorization or a
referral by the primary care provider in order to obtain coverage for such
benefits, and
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`(2) treats the ordering of other routine care
related to the care described in subparagraph (A) or (B) of subsection
(a)(1), by the participating physician providing the care described in
either such subparagraph, as the authorization of the primary care provider
with respect to such care.
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`(c) RULE OF CONSTRUCTION- Nothing in subsection
(b)(2) shall waive any requirements of coverage relating to medical necessity
or appropriateness with respect to coverage of gynecological or obstetric care
so ordered. Nothing in subsection (b) shall be construed to preclude the
health plan from requiring that the obstetrician or gynecologist notify the
primary care provider or the plan of treatment decisions.
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`SEC. 724. PATIENT ACCESS TO PEDIATRIC CARE.
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`(a) IN GENERAL- In any case in which a group
health plan (other than a fully insured group health plan)--
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`(1) provides coverage for benefits consisting
of pediatric care by a participating pediatrician; and
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`(2) requires or provides for designation by a
participant or beneficiary of a participating primary care provider;
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if the primary care provider designated by such a
participant or beneficiary is not a physician as described in paragraph (1),
then the plan shall meet the requirements of subsection (b).
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`(b) REQUIREMENTS- A group health plan (other than
a fully insured group health plan) meets the requirements of this subsection,
in connection with the coverage of benefits described in subsection (a)
consisting of care described in subsection (a)(1), if the plan--
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`(1) does not require authorization or a
referral by the primary care provider in order to obtain coverage for such
benefits, and
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`(2) treats the ordering of other routine care
of the same type, by the participating physician providing the care
described in subsection (a)(1), as the authorization of the primary care
provider with respect to such care.
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`(c) CONSTRUCTION- Nothing in subsection (b)(2)
shall waive any requirements of coverage relating to medical necessity or
appropriateness with respect to coverage of pediatric care so ordered.
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`SEC. 725. CONTINUITY OF CARE.
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`(a) IN GENERAL-
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`(1) TERMINATION OF PROVIDER- If a contract
between a group health plan (other than a fully insured group health plan)
and a health care provider is terminated (as defined in paragraph (2)), or
benefits or coverage provided by a health care provider are terminated
because of a change in the terms of provider 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--
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`(A) notify the individual on a timely basis
of such termination;
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`(B) provide the individual with an
opportunity to notify the plan of a need for transitional care; and
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`(C) in the case of termination described in
paragraph (2), (3), or (4) of subsection (b), and 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 subsection (b)).
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`(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.
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`(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.
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`(b) TRANSITIONAL PERIOD-
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`(1) GENERAL RULE- Except as provided in
paragraph (3), the transitional period under this subsection shall extend
for up to 90 days from the date of the notice described in subsection
(a)(1)(A) of the provider's termination.
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`(2) INSTITUTIONAL CARE- Subject to paragraph
(1), the transitional period under this subsection for institutional or
inpatient care from a provider shall extend until the discharge or
termination of the period of institutionalization and also shall include
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 announcement of the termination of the provider status under
subsection (a)(1)(A) or if the individual on such date was on an established
waiting list or otherwise scheduled to have such care.
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`(3) PREGNANCY- Notwithstanding paragraph (1),
if--
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`(A) a participant or beneficiary has entered
the second trimester of pregnancy at the time of a provider's termination
of participation; and
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`(B) the provider was treating the pregnancy
before the date of the termination;
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the transitional period under this subsection
with respect to provider's treatment of the pregnancy shall extend through
the provision of post-partum care directly related to the delivery.
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`(4) TERMINAL ILLNESS- Subject to paragraph (1),
if--
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`(A) a participant or beneficiary was
determined to be terminally ill (as determined under section
1861(dd)(3)(A) of the Social Security Act) prior to a provider's
termination of participation; and
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`(B) the provider was treating the terminal
illness before the date of termination;
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the transitional period under this subsection
shall be for care directly related to the treatment of the terminal illness.
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`(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 provider under subsection (a)(1)(B) upon
the provider agreeing to the following terms and conditions:
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`(1) The provider agrees to accept reimbursement
from the plan and individual involved (with respect to cost-sharing) at the
rates applicable prior to the start of the transitional period as payment in
full (or, in the case described in subsection (b)(2), 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 imposed if the contract referred to in subsection
(a)(1) had not been terminated.
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`(2) The provider agrees to adhere to the
quality assurance standards of the plan responsible for payment under
paragraph (1) and to provide to such plan necessary medical information
related to the care provided.
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`(3) The provider agrees otherwise to adhere to
such plan's policies and procedures, including procedures regarding
referrals and obtaining prior authorization and providing services pursuant
to a treatment plan (if any) approved by the plan.
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`(d) RULE OF CONSTRUCTION- Nothing in this section
shall be construed to require the coverage of benefits which would not have
been covered if the provider involved remained a participating provider.
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`(e) DEFINITION- In this section, the term `health
care provider' or `provider' means--
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`(1) any individual who is engaged in the
delivery of health care services in a State and who is required 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
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`(2) any entity that is engaged in the delivery
of health care services in a State and that, if it is required 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.
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`SEC. 726. PROTECTION OF PATIENT-PROVIDER
COMMUNICATIONS.
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`(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 under the contract, if the
professional is acting within the lawful scope of practice.
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`(b) RULE OF CONSTRUCTION- Nothing in this section
shall be construed as requiring a group health plan
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out][Struck out->] (other than a fully insured group health plan) to
provide specific benefits under the terms of such plan.
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`SEC. 727. GENERALLY APPLICABLE PROVISION.
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`In the case of a group health plan that provides
benefits under 2 or more coverage options, the requirements of sections 721,
723, 724, 725 and 726 shall apply separately with respect to each coverage
option.'.
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(b) DEFINITION- Section 733(a) of the Employee
Retirement Income Security Act of 1974 (42 U.S.C. 1186(a)) is amended by
adding at the end the following:
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`(3) FULLY INSURED GROUP HEALTH PLAN- The term
`fully insured group health plan' means a group health plan where benefits
are provided pursuant to the terms of an arrangement between a group health
plan and a health insurance issuer and are guaranteed by the health
insurance issuer under a contract or policy of insurance.'.
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(c) 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
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(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:
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`SUBPART C--PATIENT RIGHT TO MEDICAL ADVICE AND CARE
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`Sec. 721. Patient access to emergency medical
care.
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`Sec. 722. Offering of choice of coverage
options.
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`Sec. 723. Patient access to obstetric and
gynecological care.
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`Sec. 724. Patient access to pediatric care.
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`Sec. 725. Continuity of care.
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`Sec. 726. Protection of patient-provider
communications.
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`Sec. 727. Generally applicable provisions.'.
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SEC. 102. EFFECTIVE DATE AND RELATED RULES.
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(a) IN GENERAL- The amendments made by this
subtitle shall apply with respect to plan years beginning on or after January
1 of the second calendar year 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.
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(b) LIMITATION ON ENFORCEMENT ACTIONS- No
enforcement action shall be taken, pursuant to the amendments 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.
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Subtitle B--Right to Information About Plans and
Providers
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SEC. 111. INFORMATION ABOUT PLANS.
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(a) IN GENERAL- Subpart B of part 7 of subtitle B
of title I of the Employee Retirement Income Security Act of 1974, as amended
by the Omnibus Consolidated and Emergency Supplemental Appropriations Act,
1999 (Public Law 105-277), is amended by adding at the end the following:
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`SEC. 714. HEALTH PLAN COMPARATIVE INFORMATION.
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`(a) REQUIREMENT- A group health plan, or health
insurance issuer in connection with group health insurance coverage, shall,
not later than 12 months after the date of enactment of this section, provide
for the disclosure, in a clear and accurate form to each enrollee, or upon
request to a potential enrollee eligible to receive benefits under the plan,
or plan sponsor with which the plan or issuer has contracted, of the
information described in subsection (b).
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`(b) REQUIRED INFORMATION- The informational
materials to be distributed under this section shall include for each health
benefit plan the following:
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`(1) A description of the covered items and
services under each such plan and any in- and out-of-network features of
each such plan.
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`(2) A description of any cost-sharing,
including premiums, deductibles, coinsurance, and copayment amounts, for
which the enrollee will be responsible, including any annual or lifetime
limits on benefits, for each such plan.
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`(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.
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`(4) A description of any restrictions on
payments for services furnished to an enrollee by a health care professional
that is not a participating professional and the liability of the enrollee
for additional payments for these services.
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`(5) A description of the service area of each
such plan, including the provision of any out-of-area coverage.
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`(6) A description of the extent to which
enrollees 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 services).
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`(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
procedures to be used to obtain preauthorization for
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out][Struck out->] health services (including telephone numbers and
mailing addresses), including referrals for specialty care.
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`(9) 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.
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`(10) A summary of the rules for access to
emergency room care. Also, any available educational material regarding
proper use of emergency services.
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`(11) 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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`(12) A description of the specific preventative
services covered under the plan if such services are covered.
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`(13) A statement regarding--
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`(A) the manner in which an enrollee may
access an obstetrician, gynecologist, or pediatrician in accordance with
section 723 or 724;
[<-Struck out]
`(B) the manner in which an enrollee obtains
continuity of care as provided for in section 725; and
[<-Struck
out]
`(C) the manner in which an enrollee has
access to the medical records of the enrollee in accordance with subtitle
A of title II of the Patients' Bill of Rights Act.
[<-Struck
out]
`(14) A statement that the following
information, and instructions on obtaining such information (including
telephone numbers and, if available, Internet websites), shall be made
available upon request:
[<-Struck out]
`(A) The names, addresses, telephone numbers,
and State licensure status of the plan's participating health care
professionals and participating health care facilities, and, if available,
the education, training, speciality qualifications or certifications of
such professionals.
[<-Struck out]
`(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
requirement of this subparagraph shall not be construed as requiring plans
to provide information concerning proprietary payment methodology.
[<-Struck out]
`(C) A summary description of the methods used
for compensating health care facilities, including per diem,
fee-for-service, capitation, bundled payments, or a combination thereof.
The requirement of this subparagraph shall not be construed as requiring
plans to provide information concerning proprietary payment methodology.
[<-Struck out]
`(D) A summary description of the procedures
used for utilization review.
[<-Struck out]
`(E) The list of the specific prescription
medications included in the formulary of the plan, if the plan uses a
defined formulary, and any provision for obtaining off-formulary
medications.
[<-Struck out]
`(F) A description of the specific exclusions
from coverage under the plan.
[<-Struck out]
`(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.
[<-Struck
out]
`(H) Any information that is made public by
accrediting organizations in the process of accreditation if the plan is
accredited, or any additional quality indicators that the plan makes
available.
[<-Struck out]
`(c) MANNER OF DISTRIBUTION-
[<-Struck
out]
`(1) IN GENERAL- The information described in
this section shall be distributed in an accessible format that is
understandable to an average plan enrollee.
[<-Struck out]
`(2) RULE OF CONSTRUCTION- For purposes of this
section, a group health plan, or health insurance issuer in connection with
group health insurance coverage, in reliance on records maintained by the
plan or issuer, shall be deemed to have met the requirements of this section
if the plan or issuer provides the information requested under this
section--
[<-Struck out]
`(A) in the case of the plan, to participants
and beneficiaries at the address contained in such records with respect to
such participants and beneficiaries; or
[<-Struck out]
`(B) in the case of the issuer, to the
employer of a participant if the employer provides for the coverage of
such participant under the plan involved or to participants and
beneficiaries at the address contained in such records with respect to
such participants and beneficiaries.
[<-Struck out]
`(d) RULE OF CONSTRUCTION- Nothing in this section
may be construed to prohibit a group health plan,
[<-Struck out][Struck out->] or health insurance issuer in connection with group
health insurance coverage, from distributing any other additional information
determined by the plan or issuer to be important or necessary in assisting
participants and beneficiaries enrollees or upon request potential participants
in the selection of a health plan or from providing information under subsection
(b)(13) as part of the required information.
[<-Struck out]
`(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 professional'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 practitioner, clinical nurse specialist, certified
registered nurse anesthetist, and certified nurse-midwife), licensed certified
social worker, registered respiratory therapist, and certified respiratory
therapy technician.'.
[<-Struck out]
(b) CONFORMING AMENDMENTS-
[<-Struck
out]
(1) Section 732(a) of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1185(a)) is amended by striking
`section 711, and inserting `sections 711 and 714'.
[<-Struck
out]
(2) 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 following:
[<-Struck out]
`Sec. 714. Health plan comparative
information.'.
[<-Struck out]
SEC. 112. INFORMATION ABOUT PROVIDERS.
[<-Struck out]
(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--
[<-Struck out]
(1) an analysis of information concerning health
care professionals that is currently available to patients, 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;
[<-Struck out]
(2) an evaluation of the legal and other
barriers to the sharing of information concerning health care professionals;
and
[<-Struck out]
(3) recommendations for the disclosure of
information on health care professionals, including the competencies and
professional qualifications of such practitioners, to better facilitate
patient choice, quality improvement, and market competition.
[<-Struck out]
(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 committees of Congress a copy of the report
and study conducted under subsection (a).
[<-Struck out]
Subtitle C--Right to Hold Health Plans
Accountable
[<-Struck out]
SEC. 121. AMENDMENT TO EMPLOYEE RETIREMENT INCOME
SECURITY ACT OF 1974.
[<-Struck out]
(a) IN GENERAL- Section 503 of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1133) is amended to read as
follows:
[<-Struck out]
`SEC. 503. CLAIMS PROCEDURE, COVERAGE DETERMINATION,
GRIEVANCES AND APPEALS.
[<-Struck out]
`(a) CLAIMS PROCEDURE- In accordance with
regulations of the Secretary, every employee benefit plan shall--
[<-Struck out]
`(1) provide adequate notice in writing to any
participant or beneficiary whose claim for benefits under the plan has been
denied, setting forth the specific reasons for such denial, written in a
manner calculated to be understood by the participant, and
[<-Struck out]
`(2) afford a reasonable opportunity to any
participant whose claim for benefits has been denied for a full and fair
review by the appropriate named fiduciary of the decision denying the claim.
[<-Struck out]
`(b) COVERAGE DETERMINATIONS UNDER GROUP HEALTH
PLANS-
[<-Struck out]
`(1) PROCEDURES-
[<-Struck out]
`(A) IN GENERAL- A group health plan or health
insurance issuer conducting utilization review shall ensure that
procedures are in place for--
[<-Struck out]
`(i) making determinations regarding whether
an enrollee is eligible to receive a payment or coverage for health
services under the plan or coverage involved and any cost-sharing amount
that the enrollee is required to pay with respect to such service;
[<-Struck out]
`(ii) notifying covered enrollees (or the
legal representative of such enrollees) and the treating health care
professionals involved regarding determinations made under the plan or
issuer and any additional payments that the enrollee may be required to
make with respect to such service; and
[<-Struck
out]
`(iii) responding to requests, either
written or oral, for coverage determinations or for internal appeals
from an enrollee (or the legal representative of such enrollee) or the
treating health care professional.
[<-Struck out]
`(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 provide
written evidence of such request.
[<-Struck out]
`(2) TIMELINE FOR MAKING DETERMINATIONS-
[<-Struck out]
`(A) ROUTINE DETERMINATION- A group health
plan or a health insurance issuer shall maintain procedures to ensure that
prior authorization determinations concerning the provision of
non-emergency items or services are made within 30 days from the date on
which the request 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.
[<-Struck out]
`(B) EXPEDITED DETERMINATION-
[<-Struck out]
`(i) IN GENERAL- A prior authorization
determination under this subsection shall be made within 72 hours after
a request is received by the plan or issuer under clause (ii) or (iii).
[<-Struck out]
`(ii) REQUEST BY ENROLLEE- A plan or issuer
shall maintain procedures for expediting a prior authorization
determination under this subsection upon the request of an enrollee 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 enrollee.
[<-Struck out]
`(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 indicates that the treating health care professional has
documented, based on the medical exigencies, that a determination under
the procedures described in subparagraph (A) could seriously jeopardize
the life or health of the enrollee.
[<-Struck out]
`(C) CONCURRENT DETERMINATIONS- A plan or
issuer shall maintain procedures to certify or deny coverage of an
extended stay or additional services.
[<-Struck out]
`(D) RETROSPECTIVE DETERMINATION- A plan or
issuer shall maintain procedures to ensure that, with respect to the
retrospective review of a determination made under paragraph (1), the
determination shall be made within 30 working days of the date on which
the plan or issuer receives all necessary information.
[<-Struck
out]
`(3) NOTICE OF DETERMINATIONS-
[<-Struck out]
`(A) ROUTINE DETERMINATION- With respect 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 enrollee
(or the legal representative of the enrollee), and consistent with the
medical exigencies of the case, to the treating health care professional
involved not later than 2 working days after the date on which the
determination is made.
[<-Struck out]
`(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 enrollee
(or the legal representative of the enrollee), and consistent with the
medical exigencies of the case, to the treating health care professional
involved within the 72 hour period described in paragraph (2)(B).
[<-Struck out]
`(C) CONCURRENT REVIEWS- With respect to the
determination under a plan or issuer under paragraph (1) to certify or
deny coverage of an extended stay or additional services, the plan or
issuer shall issue notice of such determination to the treating health
care professional and to the enrollee involved (or the legal
representative of the enrollee) within 1 working day of the date on which
the initial notice was issued.
[<-Struck out]
`(D) RETROSPECTIVE REVIEWS- With respect to
the retrospective review under a plan or issuer of a determination made
under paragraph (1), a determination shall be made within 30 working days
of the date on which the plan or issuer receives all necessary
information. The plan or issuer shall issue written notice of an approval
or disapproval of a determination under this subparagraph to the enrollee
(or the legal representative of the enrollee) and health care provider
involved within 5 working days of the date on which such determination is
made.
[<-Struck out]
`(E) REQUIREMENTS OF NOTICE OF ADVERSE
COVERAGE DETERMINATIONS- A written or electronic 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
enrollee (or the legal representative of the enrollee) and treating health
care professional (if any) involved and shall include--
[<-Struck out]
`(i) the reasons for the determination
(including the clinical or scientific-evidence based rationale used in
making the determination) written in a manner to be understandable to
the average enrollee;
[<-Struck out]
`(ii) the procedures for obtaining
additional information concerning the determination; and
[<-Struck out]
`(iii) notification of the right to appeal
the determination and instructions on how to initiate an appeal in
accordance with subsection (d).
[<-Struck out]
`(c) GRIEVANCES- A group health plan or a health
insurance issuer shall have written procedures for addressing grievances
between the plan and enrollees. Determinations under such procedures shall be
non-appealable.
[<-Struck out]
`(d) INTERNAL APPEAL OF COVERAGE DETERMINATIONS-
[<-Struck out]
`(1) IN GENERAL- An enrollee (or the legal
representative of the enrollee) and the treating health care professional
with the consent of the enrollee (or the legal representative of the
enrollee), may appeal any adverse coverage determination under subsection
(b) under the procedures described in this subsection.
[<-Struck
out]
`(2) RECORDS- A group health plan and a health
insurance issuer shall maintain written records, for at least 6 years, with
respect to any appeal under this subsection for purposes of internal quality
assurance and improvement.
[<-Struck out]
`(3) ROUTINE DETERMINATIONS- A group health plan
or a health insurance issuer shall provide for 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 request for such appeal is
received.
[<-Struck out]
`(4) EXPEDITED DETERMINATION-
[<-Struck out]
`(A) IN GENERAL- An expedited determination
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 appeal is received by the plan or
issuer under subparagraph (B) or (C).
[<-Struck out]
`(B) REQUEST BY ENROLLEE- A plan or issuer
shall maintain procedures for expediting a prior authorization
determination under this subsection upon the request of an enrollee 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 enrollee.
[<-Struck out]
`(C) 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 indicates that the treating health care professional has
documented, based on the medical exigencies that a determination under the
procedures described in paragraph (2) could seriously jeopardize the life
or health of the enrollee.
[<-Struck out]
`(5) CONDUCT OF REVIEW- A review of an adverse
coverage determination under this subsection shall be conducted by an
individual with appropriate expertise who was not involved in the initial
determination.
[<-Struck out]
`(6) LACK OF MEDICAL NECESSITY- A review of an
appeal under this subsection relating to a determination to deny coverage
based on a lack of medical necessity or appropriateness, or based on an
experimental or investigational treatment, shall be made only by a physician
with appropriate expertise in the field of medicine involved who was not
involved in the initial determination.
[<-Struck out]
`(7) NOTICE-
[<-Struck out]
`(A) IN GENERAL- Written notice of a
determination made under an internal review process shall be issued to the
enrollee (or the legal representative of the enrollee) and the treating
health care professional not later than 2 working days after the
completion of the review (or within the 72-hour period referred to in
paragraph (4) if applicable).
[<-Struck out]
`(B) ADVERSE COVERAGE DETERMINATIONS- With
respect to an adverse coverage determination made under this subsection,
the notice described in subparagraph (A) shall include--
[<-Struck out]
`(i) the reasons for the determination
(including the clinical or scientific-evidence based rationale used in
making the determination) written in a manner to be understandable to
the average enrollee;
[<-Struck out]
`(ii) the procedures for obtaining
additional information concerning the determination; and
[<-Struck out]
`(iii) notification of the right to an
external review under subsection (e) and instructions on how to initiate
such a review.
[<-Struck out]
`(e) EXTERNAL REVIEW-
[<-Struck out]
`(1) IN GENERAL- A group health plan or a health
insurance issuer shall have written procedures to permit an enrollee (or the
legal representative of the enrollee) access to an external review with
respect to a coverage determination concerning a particular item or service
where--
[<-Struck out]
`(A) the particular item or service involved,
when medically appropriate and necessary, is a covered benefit under the
[<-Struck out][Struck out->] terms and
[<-Struck out]
[Struck out->] conditions of the contract between the plan or issuer
and the enrollee;
[<-Struck out]
`(B) the coverage determination involved
denied coverage for such item or service because the provision of such
item or service--
[<-Struck out]
`(i) does not meet the plan's or issuer's
requirements for medical appropriateness or necessity and the amount
involved exceeds a significant financial threshold; or
[<-Struck out]
`(ii) would constitute experimental or
investigational treatment and there is a significant risk of placing the
life or health of the enrollee in jeopardy; and
[<-Struck
out]
`(C) the enrollee has completed the internal
appeals process with respect to such determination.
[<-Struck
out]
`(2) INITIATION OF THE EXTERNAL REVIEW PROCESS-
[<-Struck out]
`(A) FILING OF REQUEST- An enrollee (or the
legal representative of the enrollee) who desires to have an external
review conducted under this subsection shall file a written request for
such a review with the plan or issuer involved not later than 30 working
days after the receipt of a final denial of a claim under subsection (d).
Any such request shall include the consent of the enrollee (or the legal
representative of the enrollee) for the release of medical information and
records to external reviewers regarding the enrollee if such information
is necessary for the proper conduct of the external review.
[<-Struck out]
`(B) INFORMATION AND NOTICE- 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 select an external appeals entity under paragraph
(3)(A) that shall be responsible for designating an external reviewer
under paragraph (3)(B).
[<-Struck out]
`(C) PROVISION OF INFORMATION- The plan or
issuer involved shall forward all necessary information (including 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 enrollee for the coverage denial, and evidence of the enrollee's
coverage) to the external reviewer selected under paragraph (3)(B).
[<-Struck out]
`(D) NOTIFICATION- The plan or issuer involved
shall send a written notification to the enrollee (or the legal
representative of the enrollee) and the plan administrator, indicating
that an external review has been initiated.
[<-Struck
out]
`(3) CONDUCT OF EXTERNAL REVIEW-
[<-Struck out]
`(A) DESIGNATION OF EXTERNAL APPEALS ENTITY BY
PLAN OR ISSUER- A plan or issuer that receives a request for an external
review under paragraph (2)(A) shall designate one of the following
entities to serve as the external appeals entity:
[<-Struck
out]
`(i) An external review entity licensed or
credentialed by a State.
[<-Struck out]
`(ii) A State agency established for the
purpose of conducting independent external reviews.
[<-Struck
out]
`(iii) Any entity under contract with the
Federal Government to provide external review services.
[<-Struck out]
`(iv) Any entity accredited as an external
review entity by an accrediting body recognized by the Secretary for
such purpose.
[<-Struck out]
`(v) Any fully accredited teaching hospital.
[<-Struck out]
`(vi) Any other entity meeting criteria
established by the Secretary for purposes of this subparagraph.
[<-Struck out]
`(B) DESIGNATION OF EXTERNAL REVIEWER BY
EXTERNAL APPEALS ENTITY- The external appeals entity designated under
subparagraph (A) shall, not later than 30 days after the date on which
such entity is designated under subparagraph (A), or earlier in accordance
with the medical exigencies of the case, designate one or more individuals
to serve as external reviewers with respect to a request received under
paragraph (2)(A). Such reviewers shall be independent medical experts who
shall--
[<-Struck out]
`(i) be appropriately credentialed or
licensed in any State to deliver health care services;
[<-Struck out]
`(ii) not have any material, professional,
familial, or financial affiliation with the case under review, the
enrollee involved, the treating health care professional, the
institution where the treatment
[<-Struck out][Struck out->] would take place, or the manufacturer of any drug,
device, procedure, or other therapy proposed for the enrollee whose treatment is
under review;
[<-Struck out]
`(iii) be experts in the diagnosis or
treatment under review and, when reasonably available, be of the same
speciality of the physician prescribing the treatment in question;
[<-Struck out]
`(iv) receive only reasonable and customary
compensation from the group health plan or health insurance issuer in
connection with the external review that is not contingent on the
decision rendered by the reviewer; and
[<-Struck
out]
`(v) not be held liable for decisions
regarding medical determinations (but may be held liable for actions
that are arbitrary and capricious).
[<-Struck out]
`(4) STANDARD OF REVIEW-
[<-Struck
out]
`(A) IN GENERAL- An external reviewer shall--
[<-Struck out]
`(i) make a determination based on the
medical necessity, appropriateness, experimental or investigational
nature of the coverage denial;
[<-Struck out]
`(ii) take into consideration any
evidence-based decision making or clinical practice guidelines used by
the group health plan or health insurance issuer in conducting
utilization review; and
[<-Struck out]
`(iii) submit a report on the final
determinations of the review involved to--
[<-Struck
out]
`(I) the plan or issuer involved;
[<-Struck out]
`(II) the enrollee involved (or the legal
representative of the enrollee); and
[<-Struck
out]
`(III) the health care professional
involved.
[<-Struck out]
`(B) NOTICE- The plan or issuer involved shall
ensure that the enrollee receives notice, within 30 days after the
determination of the independent medical expert, regarding the actions of
the plan or issuer with respect to the determination of such expert under
the external review.
[<-Struck out]
`(5) TIMEFRAME FOR REVIEW-
[<-Struck
out]
`(A) IN GENERAL- An external reviewer shall
complete a review of an adverse coverage determination in accordance with
the medical exigencies of the case.
[<-Struck out]
`(B) LIMITATION- Notwithstanding subparagraph
(A), a review described in such subparagraph shall be completed not later
than 30 working days after the later of--
[<-Struck
out]
`(i) the date on which such reviewer is
designated; or
[<-Struck out]
`(ii) the date on which all information
necessary to completing such review is received.
[<-Struck
out]
`(6) BINDING DETERMINATION- The determination of
an external reviewer under this subsection shall be binding upon the plan or
issuer if the provisions of this subsection or the procedures implemented
under such provisions were complied with by the external reviewer.
[<-Struck out]
`(7) STUDY- Not later than 2 years after the
date of enactment of this section, the General Accounting Office shall
conduct a study of a statistically appropriate sample of completed external
reviews. Such study shall include an assessment of the process involved
during an external review and the basis of decisionmaking by the external
reviewer. The results of such study shall be submitted to the appropriate
committees of Congress.
[<-Struck out]
`(8) EFFECT ON CERTAIN PROVISIONS- Nothing in
this section shall be construed as affecting or modifying section 514 of
this Act with respect to a group health plan.
[<-Struck out]
`(f) RULE OF CONSTRUCTION- Nothing in this section
shall be construed to prohibit a plan administrator or plan fiduciary or
health plan medical director from requesting an external review by an external
reviewer without first completing the internal review process.
[<-Struck out]
`(g) DEFINITIONS- In this section:
[<-Struck out]
`(1) ADVERSE COVERAGE DETERMINATION- The term
`adverse coverage determination' means a coverage determination under the
plan which results in a denial of coverage or reimbursement.
[<-Struck out]
`(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 reimbursable under the coverage and terms
of the contract.
[<-Struck out]
`(3) ENROLLEE- The term enrollee means a
participant or beneficiary.
[<-Struck out]
`(4) GRIEVANCE- The term `grievance' means any
enrollee complaint that does not involve a coverage determination.
[<-Struck out]
`(5) GROUP HEALTH PLAN- The term `group health
plan' shall have the meaning given such term in section 733(a). In applying
this paragraph, excepted benefits described in section 733(c) shall not be
treated as benefits consisting of medical care.
[<-Struck
out]
`(6) 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.
[<-Struck
out]
`(7) HEALTH INSURER- The term `health insurer'
means an insurance company, insurance service, or an insurance organization
that meets the requirements of section 733(b)(2) and that offers health
insurance coverage in connection with a group health plan.
[<-Struck out]
`(8) 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.
[<-Struck out]
`(9) TREATING HEALTH CARE PROFESSIONAL- The term
`treating health care professional' with respect to a group health plan,
health insurance issuer or provider sponsored organization means a
practitioner who is acting within the scope of their State licensure or
certification for the delivery of health care services and who is primarily
responsible for delivering those services to the enrollee.
[<-Struck out]
`(10) UTILIZATION REVIEW- The term `utilization
review' with respect to a group health plan or health insurance coverage
means a set of formal techniques designed to monitor the use of, or evaluate
the clinical necessity, appropriateness, efficacy, or efficiency of, health
care services, procedures, or settings. Techniques may include ambulatory
review, prospective review, second opinion, certification, concurrent
review, case management, discharge planning or retrospective review.'
[<-Struck out]
(b) ENFORCEMENT- Section 502(c)(1) of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1132(c)(1)) is amended by
inserting after `or section 101(e)(1)' the following: `, or fails to comply
with a coverage determination as required under section 503(e)(6),'.
[<-Struck out]
(c) CONFORMING AMENDMENT- The table of contents in
section 1 of the Employee Retirement Income
[<-Struck out][Struck out->] Security Act of 1974 is amended by striking the item
relating to section 503 and inserting the following new item:
[<-Struck out]
`Sec. 503. Claims procedures, coverage
determination, grievances and appeals.'.
[<-Struck out]
(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.
[<-Struck out]
TITLE II--INDIVIDUAL RIGHTS WITH RESPECT TO
PERSONAL MEDICAL INFORMATION
[<-Struck out]
SEC. 201. SHORT TITLE.
[<-Struck out]
This title may be cited as the `Personal Medical
Information Access Act'.
[<-Struck out]
Subtitle A--Access to Medical Records
[<-Struck out]
SEC. 211. INSPECTION AND COPYING OF PROTECTED HEALTH
INFORMATION.
[<-Struck out]
(a) IN GENERAL- At the request of an individual
and except as provided in subsection (b), a health care provider, health plan,
employer, health or life insurer, school, or university shall permit an
individual who is the subject of protected health information or the
individual's designee, to inspect and copy protected health information
concerning the individual, including records created under section 212 that
such entity maintains. Such entity may set forth appropriate procedures to be
followed for such inspection or copying and may require an individual to pay
reasonable costs associated with such inspection or copying.
[<-Struck out]
(b) EXCEPTIONS- Unless ordered by a court of
competent jurisdiction, an entity described in subsection (a) is not required
to permit the inspection or copying of protected health information if any of
the following conditions are met:
[<-Struck out]
(1) ENDANGERMENT TO LIFE OR SAFETY- The entity
determines that the disclosure of the information could reasonably be
expected to endanger the life or physical safety of an individual.
[<-Struck out]
(2) CONFIDENTIAL SOURCE- The information
identifies, or could reasonably lead to the identification of, a person who
provided information under a promise of confidentiality concerning the
individual who is the subject of the information.
[<-Struck
out]
(3) INFORMATION COMPILED IN ANTICIPATION OF
LITIGATION- The information is compiled principally--
[<-Struck
out]
(A) in the reasonable anticipation of a civil,
criminal, or administrative action or proceeding; or
[<-Struck
out]
(B) for use in such an action or proceeding.
[<-Struck out]
(4) RESEARCH PURPOSES- The information was
collected for a research project monitored by an institutional review board,
such project is not complete, and the researcher involved reasonably
believes that access to such information would harm the conduct of the
research or invalidate or undermine the validity of the research.
[<-Struck out]
(c) DENIAL OF A REQUEST FOR INSPECTION OR COPYING-
If an entity described in subsection (a) denies a request for inspection or
copying pursuant to subsection (b), the entity shall inform the individual in
writing of--
[<-Struck out]
(1) the reasons for the denial of the request
for inspection or copying;
[<-Struck out]
(2) any procedures for further review of the
denial; and
[<-Struck out]
(3) the individual's right to file with the
entity a concise statement setting forth the request for inspection or
copying.
[<-Struck out]
(d) STATEMENT REGARDING REQUEST- If an individual
has filed a statement under subsection (c)(3), the entity in any subsequent
disclosure of the portion of the information requested under subsection (a)
shall include--
[<-Struck out]
(1) a copy of the individual's statement; and
[<-Struck out]
(2) a concise statement of the reasons for
denying the request for inspection or copying.
[<-Struck
out]
(e) INSPECTION AND COPYING OF SEGREGABLE PORTION-
An entity described in subsection (a) shall permit the inspection and copying
under subsection (a) of any reasonably segregable portion of protected health
information after deletion of any portion that is exempt under subsection (b).
[<-Struck out]
(f) DEADLINE- An entity described in subsection
(a) shall comply with or deny, in accordance with subsection (c), a request
for inspection or copying of protected health information under this section
not later than 45 days after the date on which the entity receives the
request.
[<-Struck out]
(g) RULES GOVERNING AGENTS- An agent of an entity
described in subsection (a) shall not be required to provide for the
inspection and copying of protected health information, except where--
[<-Struck out]
(1) the protected health information is retained
by the agent; and
[<-Struck out]
(2) the agent has received in writing a request
from the entity involved to fulfill the requirements of this section;
[<-Struck out]
at which time such information shall be provided
to the requesting entity. Such requesting entity shall comply with subsection
(f) with respect to any such information.
[<-Struck out]
(h) RULE OF CONSTRUCTION- This section shall not
be construed to require an entity described in subsection (a) to conduct a
formal, informal, or other hearing or proceeding concerning a request for
inspection or copying of protected health information.
[<-Struck
out]
SEC. 212. AMENDMENT OF PROTECTED HEALTH INFORMATION.
[<-Struck out]
(a) REQUIREMENT-
[<-Struck out]
(1) IN GENERAL- Except as provided in subsection
(b) and subject to paragraph (2), a health care provider, health plan,
employer, health or life insurer, school, or university that receives from
an individual a request in writing to amend protected health information
shall--
[<-Struck out]
(A) amend such information as requested;
[<-Struck out]
(B) inform the individual of the amendment
that has been made; and
[<-Struck out]
(C) make reasonable efforts to inform any
person to whom the unamended portion of the information was previously
disclosed, of any nontechnical amendment that has been made.
[<-Struck out]
(2) COMPLIANCE- An entity described in paragraph
(1) shall comply with the requirements of such paragraph within 45 days of
the date on which the request involved is received if the entity--
[<-Struck out]
(A) created the protected health information
involved; and
[<-Struck out]
(B) determines that such information is in
fact inaccurate.
[<-Struck out]
(b) REFUSAL TO AMEND- If an entity described in
subsection (a) refuses to make the amendment requested under such subsection,
the entity shall inform the individual in writing of--
[<-Struck
out]
(1) the reasons for the refusal to make the
amendment;
[<-Struck out]
(2) any procedures for further review of the
refusal; and
[<-Struck out]
(3) the individual's right to file with the
entity a concise statement setting forth the requested amendment and the
individual's reasons for disagreeing with the refusal.
[<-Struck
out]
(c) STATEMENT OF DISAGREEMENT- If an individual
has filed a statement of disagreement under subsection (b)(3), the entity
involved, in any subsequent disclosure of the disputed portion of the
information--
[<-Struck out]
(1) shall include a copy of the individual's
statement; and
[<-Struck out]
(2) may include a concise statement of the
reasons for not making the requested amendment.
[<-Struck
out]
(d) RULES GOVERNING AGENTS- The agent of an entity
described in subsection (a) shall not be required to make amendments to
protected health information, except where--
[<-Struck out]
(1) the protected health information is retained
by the agent; and
[<-Struck out]
(2) the agent has been asked by such entity to
fulfill the requirements of this section.
[<-Struck out]
If the agent is required to comply with this
section as provided for in paragraph (2), such agent shall be subject to the
45-day deadline described in subsection (a).
[<-Struck out]
(e) REPEATED REQUESTS FOR AMENDMENTS- If an entity
described in subsection (a) receives a request for an amendment of information
as provided for in such subsection and a statement of disagreement has been
filed pursuant to subsection (c), the entity shall inform the individual of
such filing and shall not be required to carry out the procedures required
under this section.
[<-Struck out]
(f) RULES OF CONSTRUCTION- This section shall not
be construed to--
[<-Struck out]
(1) require that an entity described in
subsection (a) conduct a formal, informal, or other hearing or proceeding
concerning a request for an amendment to protected health information;
[<-Struck out]
(2) require a provider to amend an individual's
protected health information as to the type, duration, or quality of
treatment the individual believes he or she should have been provided; or
[<-Struck out]
(3) permit any deletions or alterations of the
original information.
[<-Struck out]
SEC. 213. NOTICE OF CONFIDENTIALITY PRACTICES.
[<-Struck out]
(a) PREPARATION OF WRITTEN NOTICE- A health care
provider, health plan, health oversight agency, public health authority,
employer, health or life insurer, health researcher, school or university
shall post or provide, in writing and in a clear and conspicuous manner,
notice of the entity's confidentiality practices, that shall include--
[<-Struck out]
(1) a description of an individual's rights with
respect to protected health information;
[<-Struck out]
(2) the procedures established by the entity for
the exercise of the individual's rights; and
[<-Struck out]
(3) the right to obtain a copy of the notice of
the confidentiality practices required under this subtitle.
[<-Struck out]
(b) MODEL NOTICE- The Secretary, in consultation
with the National Committee on Vital and Health Statistics and the National
Association of Insurance Commissioners, and after notice and opportunity for
public comment, shall develop and disseminate model notices of confidentiality
practices. Use of the model notice shall serve as a defense against claims of
receiving inappropriate notice.
[<-Struck out]
Subtitle B--Establishment of Safeguards
[<-Struck out]
SEC. 221. ESTABLISHMENT OF SAFEGUARDS.
[<-Struck out]
A health care provider, health plan, health
oversight agency, public health authority, employer, health or life insurer,
health researcher, law enforcement official, school or university shall
establish and maintain appropriate administrative, technical, and physical
safeguards to protect the confidentiality, security, accuracy, and integrity
of protected health information created, received, obtained, maintained, used,
transmitted, or disposed of by such entity.
[<-Struck out]
Subtitle C--Enforcement; Definitions
[<-Struck out]
SEC. 231. CIVIL PENALTY.
[<-Struck
out]
(a) VIOLATION- A health care provider, health
researcher, health plan, health oversight agency, public health agency, law
enforcement agency, employer, health or life insurer, school, or university,
or the agent of any such individual or entity, who the Secretary, in
consultation with the Attorney General, determines has substantially and
materially failed to comply with this Act shall, for a violation of this
title, be subject, in addition to any other penalties that may be prescribed
by law, to a civil penalty of not more than $500 for each such violation, but
not to exceed $5,000 in the aggregate for multiple violations.
[<-Struck out]
(b) PROCEDURES FOR IMPOSITION OF PENALTIES-
Section 1128A of the Social Security Act, other than subsections (a) and (b)
and the second sentence of subsection (f) of that section, shall apply to the
imposition of a civil, monetary, or exclusionary penalty under this section in
the same manner as such provisions apply with respect to the imposition of a
penalty under section 1128A of such Act.
[<-Struck out]
SEC. 232. DEFINITIONS.
[<-Struck out]
In this title:
[<-Struck out]
(1) AGENT- The term `agent' means a person who
represents and acts for another under the contract or relation of agency, or
whose function is to bring about, modify, affect, accept performance of, or
terminate contractual obligations between the principal and a third person,
including a contractor.
[<-Struck out]
(2) DISCLOSE- The term `disclose' means to
release, transfer, provide access to, or otherwise divulge protected health
information to any person other than the individual who is the subject of
such information. Such term includes the initial disclosure and any
subsequent redisclosures of protected health information.
[<-Struck out]
(3) EMPLOYER- The term `employer' has the
meaning given such term under section 3(5) of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1002(5)), except that such term shall
include only employers of 2 or more employees.
[<-Struck
out]
(4) HEALTH CARE PROVIDER- The term `health care
provider' means a person who, with respect to a specific item of protected
health information, receives, creates, uses, maintains, or discloses the
information while acting in whole or in part in the capacity of--
[<-Struck out]
(A) a person who is licensed, certified,
registered, or otherwise authorized by Federal or State law to provide an
item or service that constitutes health care in the ordinary course of
business, or practice of a profession;
[<-Struck out]
(B) a Federal, State, or employer-sponsored
program that directly provides items or services that constitute health
care to beneficiaries; or
[<-Struck out]
(C) an officer, employee, or agent of a person
described in subparagraph (A) or (B).
[<-Struck out]
(5) HEALTH OR LIFE INSURER- The term `health or
life insurer' means a health insurance issuer as defined in section 2791 of
the Public Health Service Act (42 U.S.C. 300gg-91) or a life insurance
company as defined in section 816 of the Internal Revenue Code of 1986.
[<-Struck out]
(6) HEALTH PLAN- The term `health plan' means
any health insurance plan, including any hospital or medical service plan,
dental or other health service plan or health maintenance organization plan,
provider sponsored organization, or other program providing or arranging for
the provision of health benefits, whether or not funded through the purchase
of insurance.
[<-Struck out]
(7) PERSON- The term `person' means a
government, governmental subdivision, agency or authority; corporation;
company; association; firm; partnership; society; estate; trust; joint
venture; individual; individual representative; tribal government; and any
other legal entity.
[<-Struck out]
(8) PROTECTED HEALTH INFORMATION- The term
`protected health information' means any information (including demographic
information) whether or not recorded in any form or medium--
[<-Struck out]
(A) that relates to the past, present or
future--
[<-Struck out]
(i) physical or mental health or condition
of an individual (including the condition or other attributes of
individual cells or their components);
[<-Struck
out]
(ii) provision of health care to an
individual; or
[<-Struck out]
(iii) payment for the provision of health
care to an individual;
[<-Struck out]
(B) that is created by a health care provider,
health plan, health researcher, health oversight agency, public health
authority, employer, law enforcement official, health or life insurer,
school or university; and
[<-Struck out]
(C) that is not nonidentifiable health
information.
[<-Struck out]
(9) SCHOOL OR UNIVERSITY- The term `school or
university' means an institution or place for instruction or education,
including an elementary school, secondary school, or institution of higher
learning, a college, or an assemblage of colleges united under one corporate
organization or government.
[<-Struck out]
(10) SECRETARY- The term `Secretary' means the
Secretary of Health and Human Services.
[<-Struck out]
(11) WRITING- The term `writing' means writing
in either a paper-based or computer-based form, including electronic
signatures.
[<-Struck out]
SEC. 233. EFFECTIVE DATE.
[<-Struck
out]
The provisions of this title shall become
effective beginning on the date that is 1 year after the date of enactment of
this Act. The Secretary shall issue regulations necessary to carry out this
title before the effective date thereof.
[<-Struck out]
TITLE III--GENETIC INFORMATION AND SERVICES
[<-Struck out]
SEC. 301. SHORT TITLE.
[<-Struck out]
This title may be cited as the `Genetic
Information Nondiscrimination in Health Insurance Act of 1999'.
[<-Struck out]
SEC. 302. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME
SECURITY ACT OF 1974.
[<-Struck out]
(a) PROHIBITION OF HEALTH DISCRIMINATION ON THE
BASIS OF GENETIC INFORMATION OR GENETIC SERVICES-
[<-Struck out]
(1) NO ENROLLMENT RESTRICTION FOR GENETIC
SERVICES- Section 702(a)(1)(F) of the Employee Retirement Income Security
Act of 1974 (29 U.S.C. 1182(a)(1)(F)) is amended by inserting before the
period the following: `(including information about a request for or receipt
of genetic services)'.
[<-Struck out]
(2) NO DISCRIMINATION IN GROUP PREMIUMS BASED ON
PREDICTIVE GENETIC INFORMATION- Subpart B of part 7 of subtitle B of title I
of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 et
seq.) (as amended by section 111) is further amended by adding at the end
the following:
[<-Struck out]
`SEC. 714. PROHIBITING PREMIUM DISCRIMINATION
AGAINST GROUPS ON THE BASIS OF PREDICTIVE GENETIC INFORMATION.
[<-Struck out]
`A group health plan, or a health insurance issuer
offering group health insurance coverage in connection with a group health
plan, shall not adjust premium or contribution amounts for a group on the
basis of predictive genetic information concerning an individual in the group
or a family member of the individual (including information about a request
for or receipt of genetic services).'.
[<-Struck out]
(3) CONFORMING AMENDMENT- Section 702(b) of the
Employee Retirement Income Security
[<-Struck out][Struck out->] Act of 1974 (29 U.S.C. 1182(b)) is amended by adding
at the end the following:
[<-Struck out]
`(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
information (including information about a request for or receipt of genetic
services), see section 714.'.
[<-Struck out]
(b) LIMITATION ON COLLECTION OF PREDICTIVE GENETIC
INFORMATION- Section 702 of the Employee Retirement Income Security Act of
1974 (29 U.S.C. 1182) is amended by adding at the end the following:
[<-Struck out]
`(c) COLLECTION OF PREDICTIVE GENETIC INFORMATION-
[<-Struck out]
`(1) LIMITATION ON REQUESTING OR REQUIRING
PREDICTIVE GENETIC INFORMATION- Except as provided in paragraph (2), a group
health plan, or a health insurance issuer offering health insurance coverage
in connection with a group health plan, shall not request or require
predictive genetic information concerning an individual or a family member
of the individual (including information about a request for or receipt of
genetic services).
[<-Struck out]
`(2) INFORMATION NEEDED FOR DIAGNOSIS,
TREATMENT, OR PAYMENT-
[<-Struck out]
`(A) IN GENERAL- Notwithstanding paragraph
(1), a group health plan or health insurance issuer 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, predictive genetic information for purposes
of diagnosis, treatment, or payment relating to the provision of health
care items and services to such individual or dependent.
[<-Struck out]
`(B) NOTICE OF CONFIDENTIALITY PRACTICES AND
DESCRIPTION OF SAFEGUARDS- As a part of a request under subparagraph (A),
the group health plan or health insurance issuer shall provide to the
individual or dependent a description of the procedures in place to
safeguard the confidentiality, as described in sections 213 and 221 of the
Patients' Bill of Rights Act, of such individually identifiable
information.'.
[<-Struck out]
(c) DEFINITIONS- Section 733(d) of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1191b(d)) is amended by
adding at the end the following:
[<-Struck out]
`(5) FAMILY MEMBER- The term `family member'
means with respect to an individual--
[<-Struck out]
`(A) the spouse of the individual;
[<-Struck out]
`(B) a dependent child of the individual,
including a child who is born to or placed for adoption with the
individual; and
[<-Struck out]
`(C) all other individuals related by blood to
the individual or the spouse or child described in subparagraph (A) or
(B).
[<-Struck out]
`(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).
[<-Struck out]
`(7) GENETIC SERVICES- The term `genetic
services' means health services provided to obtain, assess, or interpret
genetic information for diagnostic and therapeutic purposes, and for genetic
education and counseling.
[<-Struck out]
`(8) PREDICTIVE GENETIC INFORMATION-
[<-Struck out]
`(A) IN GENERAL- The term `predictive genetic
information' means--
[<-Struck out]
`(i) information about an individual's
genetic tests which are associated with a statistically significant
increased risk of developing a disease or disorder;
[<-Struck
out]
`(ii) information about genetic tests of
family members of the individual; or
[<-Struck
out]
`(iii) information about the occurrence of a
disease or disorder in family members that predicts a statistically
significant increased risk of a disease or disorder in the individual.
[<-Struck out]
`(B) EXCEPTIONS- The term `predictive genetic
information' shall not include--
[<-Struck out]
`(i) information about the sex or age of the
individual;
[<-Struck out]
`(ii) information derived from routine
physical tests, such as the chemical, blood, or urine analyses of the
individual, unless such analyses are genetic tests; and
[<-Struck out]
`(iii) information about physical exams of
the individual and other information relevant to determining the current
health status of the individual so long as such information does not
include information described in clauses (i), (ii), or (iii) of
subparagraph (A).
[<-Struck out]
`(9) GENETIC TEST- The term `genetic test' means
the analysis of human DNA, RNA, chromosomes, proteins, and certain
metabolites, in order to detect disease-related genotypes, mutations,
phenotypes, or karyotypes.'.
[<-Struck out]
(d) EFFECTIVE DATE- Except as provided in this
section, 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.
[<-Struck out]
SEC. 303. AMENDMENTS TO THE PUBLIC HEALTH SERVICE
ACT.
[<-Struck out]
(a) AMENDMENTS RELATING TO THE GROUP MARKET-
[<-Struck out]
(1) PROHIBITION OF HEALTH DISCRIMINATION ON THE
BASIS OF GENETIC INFORMATION IN THE GROUP MARKET-
[<-Struck
out]
(A) IN GENERAL- Subpart 2 of part A of title
XXVII of the Public Health Service Act, as amended by the Omnibus
Consolidated and Emergency Supplemental Appropriations Act, 1999 (Public
Law 105-277), is amended by adding at the end the following new section:
[<-Struck out]
`SEC. 2707. PROHIBITING PREMIUM DISCRIMINATION
AGAINST GROUPS ON THE BASIS OF PREDICTIVE GENETIC INFORMATION IN THE GROUP
MARKET.
[<-Struck out]
`A group health plan, or a health insurance issuer
offering group health insurance coverage in connection with a group health
plan shall not adjust premium or contribution amounts for a group on the basis
of predictive genetic information concerning an individual in the group or a
family member of the individual (including information about a request for or
receipt of genetic services).'.
[<-Struck out]
(B) 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:
[<-Struck out]
`(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
information (including information about a request for or receipt of genetic
services), see section 2707.'.
[<-Struck out]
(C) LIMITATION ON COLLECTION AND DISCLOSURE OF
PREDICTIVE GENETIC INFORMATION- Section 2702 of the Public Health Service
Act (42 U.S.C. 300gg-1) is amended by adding at the end the following:
[<-Struck out]
`(c) COLLECTION OF PREDICTIVE GENETIC INFORMATION-
[<-Struck out]
`(1) LIMITATION ON REQUESTING OR REQUIRING
PREDICTIVE GENETIC INFORMATION- Except as provided in paragraph (2), a group
health plan, or a health insurance issuer offering health insurance coverage
in connection with a group health plan, shall not request or require
predictive genetic information concerning an individual or a family member
of the individual (including information about a request for or receipt of
genetic services).
[<-Struck out]
`(2) INFORMATION NEEDED FOR DIAGNOSIS,
TREATMENT, OR PAYMENT-
[<-Struck out]
`(A) IN GENERAL- Notwithstanding paragraph
(1), a group health plan or health insurance issuer 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, predictive genetic information for purposes
of diagnosis, treatment, or payment relating to the provision of health
care items and services to such individual or dependent.
[<-Struck out]
`(B) NOTICE OF CONFIDENTIALITY PRACTICES AND
DESCRIPTION OF SAFEGUARDS- As a part of a request under subparagraph (A),
the group health plan or health insurance issuer shall provide to the
individual or dependent a description of the procedures in place to
safeguard the confidentiality, as described in sections 213 and 221 of the
Patients' Bill of Rights Act, of such individually identifiable
information.'.
[<-Struck out]
(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:
[<-Struck out]
`(15) FAMILY MEMBER- The term `family member'
means, with respect to an individual--
[<-Struck out]
`(A) the spouse of the individual;
[<-Struck out]
`(B) a dependent child of the individual,
including a child who is born to or placed for adoption with the
individual; and
[<-Struck out]
`(C) all other individuals related by blood to
the individual or the spouse or child described in subparagraph (A) or
(B).
[<-Struck out]
`(16) 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.
[<-Struck out]
`(17) GENETIC SERVICES- The term `genetic
services' means health services provided to obtain, assess, or interpret
genetic information for diagnostic and therapeutic purposes, and for genetic
education and counseling.
[<-Struck out]
`(18) PREDICTIVE GENETIC INFORMATION-
[<-Struck out]
`(A) IN GENERAL- The term `predictive genetic
information' means--
[<-Struck out]
`(i) information about an individual's
genetic tests which is associated with a statistically significant
increased risk of developing a disease or disorder;
[<-Struck
out]
`(ii) information about genetic tests of
family members of the individual; or
[<-Struck
out]
`(iii) information about the occurrence of a
disease or disorder in family members that predicts a statistically
significant increased risk of a disease or disorder in the individual.
[<-Struck out]
`(B) EXCEPTIONS- The term `predictive genetic
information' shall not include--
[<-Struck out]
`(i) information about the sex or age of the
individual;
[<-Struck out]
`(ii) information derived from routine
physical tests, such as the chemical, blood, or urine analyses of the
individual, unless such analyses are genetic tests; and
[<-Struck out]
`(iii) information about physical exams of
the individual and other information relevant to determining the current
health status of the individual so long as such information does not
include information described in clauses (i), (ii), or (iii) of
subparagraph (A).
[<-Struck out]
`(19) GENETIC TEST- The term `genetic test'
means the analysis of human DNA, RNA, chromosomes, proteins, and certain
metabolites, in order to detect disease-related genotypes, mutations,
phenotypes, or karyotypes.'.
[<-Struck out]
(b) AMENDMENT RELATING TO THE INDIVIDUAL MARKET-
The first subpart 3 of part B of title XXVII of the Public Health Service Act
(42 U.S.C. 300gg-11 et seq.) (relating to other requirements), as amended by
the Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999
(Public Law 105-277) is amended--
[<-Struck out]
(1) by redesignating such subpart as subpart 2;
and
[<-Struck out]
(2) by adding at the end the following:
[<-Struck out]
`SEC. 2753. PROHIBITION OF HEALTH DISCRIMINATION ON
THE BASIS OF PREDICTIVE GENETIC INFORMATION.
[<-Struck out]
`(a) PROHIBITION ON PREDICTIVE GENETIC INFORMATION
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
individual health insurance coverage (including information about a request
for or receipt of genetic services).
[<-Struck out]
`(b) PROHIBITION ON PREDICTIVE GENETIC INFORMATION
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
enrollee or a family member of the enrollee (including information about a
request for or receipt of genetic services).
[<-Struck out]
`(c) COLLECTION OF PREDICTIVE GENETIC INFORMATION-
[<-Struck out]
`(1) LIMITATION ON REQUESTING OR REQUIRING
PREDICTIVE GENETIC INFORMATION- Except as provided in paragraph (2), a
health insurance issuer offering health insurance coverage in the individual
market shall not request or require predictive genetic information
concerning an individual or a family member of the individual (including
information about a request for or receipt of genetic services).
[<-Struck out]
`(2) INFORMATION NEEDED FOR DIAGNOSIS,
TREATMENT, OR PAYMENT-
[<-Struck out]
`(A) IN GENERAL- Notwithstanding paragraph
(1), a health insurance issuer 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, predictive genetic information for purposes of diagnosis,
treatment, or payment relating to the provision of health care items and
services to such individual or dependent.
[<-Struck
out]
`(B) NOTICE OF CONFIDENTIALITY PRACTICES AND
DESCRIPTION OF SAFEGUARDS- As
[<-Struck out][Struck out->] a part of a request under subparagraph (A), the
health insurance issuer shall provide to the individual or dependent a
description of the procedures in place to safeguard the confidentiality, as
described in sections 213 and 221 of the Patients' Bill of Rights Act, of such
individually identifiable information.'.
[<-Struck out]
(c) EFFECTIVE DATE- The amendments made by this
section shall apply with respect to--
[<-Struck out]
(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
[<-Struck out]
(2) health insurance coverage offered, sold,
issued, renewed, in effect, or operated in the individual market after 1
year after the date of enactment of this Act.
[<-Struck out]
TITLE IV--HEALTHCARE RESEARCH AND QUALITY
[<-Struck out]
SEC. 401. SHORT TITLE.
[<-Struck out]
This title may be cited as the `Healthcare
Research and Quality Act of 1999'.
[<-Struck out]
SEC. 402. AMENDMENT TO THE PUBLIC HEALTH SERVICE
ACT.
[<-Struck out]
Title IX of the Public Health Service Act (42
U.S.C. 299 et seq.) is amended to read as follows:
[<-Struck out]
`TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND
QUALITY
[<-Struck out]
`PART A--ESTABLISHMENT AND GENERAL DUTIES
[<-Struck out]
`SEC. 901. MISSION AND DUTIES.
[<-Struck
out]
`(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 Health Care Policy and Research as the Agency for
Healthcare Research and Quality.
[<-Struck out]
`(b) MISSION- The purpose of the Agency is to
enhance 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 practice, including the prevention of diseases and
other health conditions. The Agency shall promote healthcare quality
improvement by--
[<-Struck out]
`(1) conducting and supporting research that
develops and presents scientific evidence regarding all aspects of
healthcare, including--
[<-Struck out]
`(A) the development and assessment of methods
for enhancing patient participation in their own care and for facilitating
shared patient-physician decision-making;
[<-Struck
out]
`(B) the outcomes, effectiveness, and
cost-effectiveness of healthcare practices, including preventive measures
and primary, acute and long-term care;
[<-Struck out]
`(C) existing and innovative technologies;
[<-Struck out]
`(D) the costs and utilization of, and access
to healthcare;
[<-Struck out]
`(E) the ways in which healthcare services are
organized, delivered, and financed and the interaction and impact of these
factors on the quality of patient care;
[<-Struck out]
`(F) methods for measuring quality and
strategies for improving quality; and
[<-Struck out]
`(G) ways in which patients, consumers,
purchasers, and practitioners acquire new information about best practices
and health benefits, the determinants and impact of their use of this
information;
[<-Struck out]
`(2) synthesizing and disseminating available
scientific evidence for use by patients, consumers, practitioners,
providers, purchasers, policy makers, and educators; and
[<-Struck
out]
`(3) advancing private and public efforts to
improve healthcare quality.
[<-Struck out]
`(c) REQUIREMENTS WITH RESPECT TO RURAL AREAS AND
PRIORITY POPULATIONS- In carrying out subsection (b), the Director shall
undertake and support research, demonstration projects, and evaluations with
respect to--
[<-Struck out]
`(1) the delivery of health services in rural
areas (including frontier areas);
[<-Struck out]
`(2) health services for low-income groups, and
minority groups;
[<-Struck out]
`(3) the health of children;
[<-Struck
out]
`(4) the elderly; and
[<-Struck
out]
`(5) people with special healthcare needs,
including disabilities, chronic care and end-of-life healthcare.
[<-Struck out]
`(d) APPOINTMENT OF DIRECTOR- There shall be at
the head of the Agency an official to be known as the Director 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.
[<-Struck out]
`SEC. 902. GENERAL AUTHORITIES.
[<-Struck
out]
`(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 dissemination of information, on
healthcare, and on systems for the delivery of such care, including activities
with respect to--
[<-Struck out]
`(1) the quality, effectiveness, efficiency,
appropriateness and value of healthcare services;
[<-Struck
out]
`(2) quality measurement and improvement;
[<-Struck out]
`(3) the outcomes, cost, cost-effectiveness, and
use of healthcare services and access to such services;
[<-Struck
out]
`(4) clinical practice, including primary care
and practice-oriented research;
[<-Struck out]
`(5) healthcare technologies, facilities, and
equipment;
[<-Struck out]
`(6) healthcare costs, productivity,
organization, and market forces;
[<-Struck out]
`(7) health promotion and disease prevention,
including clinical preventive services;
[<-Struck out]
`(8) health statistics, surveys, database
development, and epidemiology; and
[<-Struck out]
`(9) medical liability.
[<-Struck
out]
`(b) HEALTH SERVICES TRAINING GRANTS-
[<-Struck out]
`(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 carrying out this
subsection, the Director shall make use of funds made available under
section 487.
[<-Struck out]
`(2) REQUIREMENTS- In developing priorities for
the allocation of training funds under this subsection, the Director shall
take into consideration shortages in the number of trained researchers
addressing the priority populations.
[<-Struck out]
`(c) MULTIDISCIPLINARY CENTERS- The Director may
provide financial assistance to assist in meeting the costs of planning and
establishing new centers, and operating 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).
[<-Struck out]
`(d) RELATION TO CERTAIN AUTHORITIES REGARDING
SOCIAL SECURITY- Activities authorized in this section may include, and shall
be appropriately coordinated with experiments, demonstration projects, and
other related activities authorized by the Social Security Act and the Social
Security Amendments of 1967. Activities under
[<-Struck out][Struck out->] 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.
[<-Struck out]
`(e) DISCLAIMER- The Agency shall not mandate
national standards of clinical practice or quality healthcare standards.
Recommendations resulting from projects funded and published by the Agency
shall include a corresponding disclaimer.
[<-Struck out]
`(f) RULE OF CONSTRUCTION- Nothing in this section
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 quality improvement activities, the Agency shall consider a wide
range of choices, providers, healthcare delivery systems, and individual
preferences.
[<-Struck out]
`PART B--HEALTHCARE IMPROVEMENT RESEARCH
[<-Struck out]
`SEC. 911. HEALTHCARE OUTCOME IMPROVEMENT RESEARCH.
[<-Struck out]
`(a) EVIDENCE RATING SYSTEMS- In collaboration
with experts from the public and private sector, the Agency shall identify and
disseminate methods or systems used to assess healthcare research results,
particularly to rate the strength of the scientific evidence behind healthcare
practice, recommendations in the research literature, and technology
assessments. The Agency shall make methods or systems for evidence rating
widely available. Agency publications containing healthcare recommendations
shall indicate the level of substantiating evidence using such methods or
systems.
[<-Struck out]
`(b) HEALTHCARE IMPROVEMENT RESEARCH CENTERS AND
PROVIDER-BASED RESEARCH NETWORKS-
[<-Struck out]
`(1) IN GENERAL- 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 strategies and
mechanisms that will link research directly with clinical practice in
geographically diverse locations throughout the United States, including--
[<-Struck out]
`(A) Healthcare Improvement Research Centers
that combine demonstrated multidisciplinary expertise in outcomes or
quality improvement research with linkages to relevant sites of care;
[<-Struck out]
`(B) Provider-based Research Networks,
including plan, facility, or delivery system sites of care (especially
primary care), that can evaluate and promote quality improvement; and
[<-Struck out]
`(C) other innovative mechanisms or strategies
to link research with clinical practice.
[<-Struck out]
`(2) REQUIREMENTS- The Director is authorized to
establish the requirements for entities applying for grants under this
subsection.
[<-Struck out]
`SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE
ORGANIZATION AND DELIVERY.
[<-Struck out]
`(a) SUPPORT FOR EFFORTS TO DEVELOP INFORMATION ON
QUALITY-
[<-Struck out]
`(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 improve healthcare quality, including the activities of accrediting
organizations.
[<-Struck out]
`(2) ROLE OF THE AGENCY- With respect to
paragraph (1), the role of the Agency shall include--
[<-Struck
out]
`(A) the identification and assessment of--
[<-Struck out]
`(i) methods for the evaluation of the
health of enrollees in health plans by type of plan, provider, and
provider arrangements; and
[<-Struck out]
`(ii) other populations, including those
receiving long-term care services;
[<-Struck out]
`(B) the ongoing development, testing, and
dissemination of quality measures, including measures of health and
functional outcomes;
[<-Struck out]
`(C) the compilation and dissemination of
healthcare quality measures developed in the private and public sector;
[<-Struck out]
`(D) assistance in the development of improved
healthcare information systems;
[<-Struck out]
`(E) the development of survey tools for the
purpose of measuring participant and beneficiary assessments of their
healthcare; and
[<-Struck out]
`(F) identifying and disseminating information
on mechanisms for the integration of information on quality into purchaser
and consumer decision-making processes.
[<-Struck out]
`(b) CENTERS FOR EDUCATION AND RESEARCH ON
THERAPEUTICS-
[<-Struck out]
`(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).
[<-Struck out]
`(2) REQUIRED ACTIVITIES- The activities
referred to in this paragraph are the following:
[<-Struck
out]
`(A) The conduct of state-of-the-art clinical
research for the following purposes:
[<-Struck out]
`(i) To increase awareness of--
[<-Struck out]
`(I) new uses of drugs, biological
products, and devices;
[<-Struck out]
`(II) ways to improve the effective use of
drugs, biological products, and devices; and
[<-Struck
out]
`(III) risks of new uses and risks of
combinations of drugs and biological products.
[<-Struck
out]
`(ii) To provide objective clinical
information to the following individuals and entities:
[<-Struck out]
`(I) Healthcare practitioners and other
providers of Healthcare goods or services.
[<-Struck
out]
`(II) Pharmacists, pharmacy benefit
managers and purchasers.
[<-Struck out]
`(III) Health maintenance organizations
and other managed healthcare organizations.
[<-Struck
out]
`(IV) Healthcare insurers and governmental
agencies.
[<-Struck out]
`(V) Patients and consumers.
[<-Struck out]
`(iii) To improve the quality of healthcare
while reducing the cost of Healthcare through--
[<-Struck
out]
`(I) an increase in the appropriate use of
drugs, biological products, or devices; and
[<-Struck
out]
`(II) the prevention of adverse effects of
drugs, biological products, and devices and the consequences of such
effects, such as unnecessary hospitalizations.
[<-Struck
out]
`(B) The conduct of research on the
comparative effectiveness, cost-effectiveness, and safety of drugs,
biological products, and devices.
[<-Struck out]
`(C) Such other activities as the Secretary
determines to be appropriate, except that a grant may not be expended to
assist the Secretary in the review of new drugs.
[<-Struck
out]
`(c) REDUCING ERRORS IN MEDICINE- The Director
shall conduct and support research and build private-public partnerships to--
[<-Struck out]
`(1) identify the causes of preventable
healthcare errors and patient injury in healthcare delivery;
[<-Struck out]
`(2) develop, demonstrate, and evaluate
strategies for reducing errors and improving patient safety; and
[<-Struck out]
`(3) promote the implementation of effective
strategies throughout the healthcare industry.
[<-Struck
out]
`SEC. 913. INFORMATION ON QUALITY AND COST OF CARE.
[<-Struck out]
`(a) IN GENERAL- In carrying out 902(a), the
Director shall--
[<-Struck out]
`(1) collect data on a nationally representative
sample of the population on the cost, use and, for fiscal year 2000 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 payments, the types and costs of private health insurance, access,
satisfaction, and quality of care for the general population and also for
children, uninsured persons, poor and near-poor individuals, and persons
with special healthcare needs;
[<-Struck out]
`(2) develop databases and tools that enable
States to track the quality, access, and use of healthcare services provided
to their residents; and
[<-Struck out]
`(3) enter into agreements with public or
private entities to use, link, or acquire databases for research authorized
under this title.
[<-Struck out]
`(b) QUALITY AND OUTCOMES INFORMATION-
[<-Struck out]
`(1) IN GENERAL- To enhance the understanding of
the quality of care, the determinants of health outcomes and functional
status, the needs of special populations as well as an understanding of
these changes over time, their relationship to healthcare access and use,
and to monitor the overall national impact of Federal and State policy
changes on healthcare, the Director, beginning in fiscal year 2000, shall
ensure that the survey conducted under subsection (a)(1) will--
[<-Struck out]
`(A) provide information on the quality of
care and patient outcomes for frequently occurring clinical conditions for
a nationally representative sample of the population; and
[<-Struck out]
`(B) provide reliable national estimates for
children and persons with special healthcare needs through the use of
supplements or periodic expansions of the survey.
[<-Struck
out]
In expanding the Medical Expenditure Panel
Survey, as in existence on the date of enactment of this title) in fiscal
year 2000 to collect information on the quality of care, the Director shall
take into account any outcomes measurements generally collected by private
sector accreditation organizations.
[<-Struck out]
`(2) ANNUAL REPORT- Beginning in fiscal year
2002, 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.
[<-Struck out]
`SEC. 914. INFORMATION SYSTEMS FOR HEALTHCARE
IMPROVEMENT.
[<-Struck out]
`In order to foster a range of innovative
approaches to the management and communication of health information, the
Agency shall support research, evaluations and initiatives to advance--
[<-Struck out]
`(1) the use of information systems for the
study of healthcare quality, including the generation of both individual
provider and plan-level comparative performance data;
[<-Struck
out]
`(2) training for healthcare practitioners and
researchers in the use of information systems;
[<-Struck
out]
`(3) the creation of effective linkages between
various sources of health information, including the development of
information networks;
[<-Struck out]
`(4) the delivery and coordination of
evidence-based healthcare services, including the use of real-time
healthcare decision-support programs;
[<-Struck out]
`(5) the structure, content, definition, and
coding of health information data and medical vocabularies in consultation
with appropriate Federal and private entities;
[<-Struck
out]
`(6) the use of computer-based health records in
outpatient and inpatient settings as a personal health record for individual
health assessment and maintenance, and for monitoring public health and
outcomes of care within populations; and
[<-Struck out]
`(7) the protection of individually identifiable
information in health services research and healthcare quality improvement.
[<-Struck out]
`SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND
ACCESS IN UNDERSERVED AREAS.
[<-Struck out]
`(a) PREVENTIVE SERVICES TASK FORCE-
[<-Struck out]
`(1) PURPOSE- The Agency shall provide ongoing
administrative, research, and technical support for the operation of the
Preventive Services Task Force. The Agency shall coordinate and support the
dissemination of the Preventive Services Task Force recommendations.
[<-Struck out]
`(2) OPERATION- The Preventive Services Task
Force shall review the scientific evidence related to the effectiveness,
appropriateness, and cost-effectiveness of clinical preventive services for
the purpose of developing recommendations, and updating previous
recommendations, regarding their usefulness in daily clinical practice. In
carrying out its responsibilities under paragraph (1), the Task Force shall
not be subject to the provisions of Appendix 2 of title 5, United States
Code.
[<-Struck out]
`(b) PRIMARY CARE RESEARCH-
[<-Struck
out]
`(1) IN GENERAL- There is established within the
Agency a Center for Primary Care Research (referred to in this subsection as
the `Center') that shall serve as the principal source of funding for
primary care 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 community.
[<-Struck out]
`(2) RESEARCH- In carrying out this section, the
Center shall conduct and support research on--
[<-Struck
out]
`(A) the nature and characteristics of primary
care practice;
[<-Struck out]
`(B) the management of commonly occurring
clinical problems;
[<-Struck out]
`(C) the management of undifferentiated
clinical problems; and
[<-Struck out]
`(D) the continuity and coordination of health
services.
[<-Struck out]
`(3) DEMONSTRATION- The Agency shall support
demonstrations into the use of new information tools aimed at improving
shared decision-making between patients and their care-givers.
[<-Struck out]
`SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY
INNOVATION.
[<-Struck out]
`(a) IN GENERAL- The Director shall promote
innovation in evidence-based clinical practice and healthcare technologies
by--
[<-Struck out]
`(1) conducting and supporting research on the
development, diffusion, and use of healthcare technology;
[<-Struck out]
`(2) developing, evaluating, and disseminating
methodologies for assessments of healthcare practices and healthcare
technologies;
[<-Struck out]
`(3) conducting intramural and supporting
extramural assessments of existing and new healthcare practices and
technologies;
[<-Struck out]
`(4) promoting education, training, and
providing technical assistance in the use of healthcare practice and
healthcare technology assessment methodologies and results; and
[<-Struck out]
`(5) working with the National Library of
Medicine and the public and private sector to develop an electronic
clearinghouse of currently available assessments and those in progress.
[<-Struck out]
`(b) SPECIFICATION OF PROCESS-
[<-Struck
out]
`(1) IN GENERAL- Not later than December 31,
2000, the Director shall develop and publish a description of the methods
used by the Agency and its contractors for practice and technology
assessment.
[<-Struck out]
`(2) CONSULTATIONS- In carrying out this
subsection, the Director shall cooperate and consult with the Assistance
Secretary for Health, the Administrator of the Health Care Financing
Administration, the Director of the National Institutes of Health, the
Commissioner of Food and Drugs, and the heads of any other interested
Federal department or agency, professional societies, and other private and
public entities.
[<-Struck out]
`(3) METHODOLOGY- The methods employed in
practice and technology assessments under paragraph (1) shall consider--
[<-Struck out]
`(A) safety, efficacy, and effectiveness;
[<-Struck out]
`(B) legal, social, and ethical implications;
[<-Struck out]
`(C) costs, benefits, and cost-effectiveness;
[<-Struck out]
`(D) comparisons to alternative technologies
and practices; and
[<-Struck out]
`(E) requirements of Food and Drug
Administration approval to avoid duplication.
[<-Struck
out]
`(c) SPECIFIC ASSESSMENTS-
[<-Struck
out]
`(1) IN GENERAL- The Director shall conduct or
support specific assessments of healthcare technologies and practices.
[<-Struck out]
`(2) REQUESTS FOR ASSESSMENTS- The Director is
authorized to conduct or support assessments, on a reimbursable basis, for
the Health Care Financing Administration, the Department of Defense, the
Department of Veterans Affairs, the Office of Personnel Management, and
other public or private entities.
[<-Struck out]
`(3) GRANTS AND CONTRACTS- In addition to
conducting assessments, the Director may make grants to, or enter into
cooperative agreements or contracts with, entities described in paragraph
(4) for the purpose of conducting assessments of experimental, emerging,
existing, or potentially outmoded healthcare technologies, and for related
activities.
[<-Struck out]
`(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,
professional organizations, third party payers, other governmental agencies,
and consortia of appropriate research entities established for the purpose
of conducting technology assessments.
[<-Struck out]
`SEC. 917. COORDINATION OF FEDERAL GOVERNMENT
QUALITY IMPROVEMENT EFFORTS.
[<-Struck out]
`(a) REQUIREMENT-
[<-Struck out]
`(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
demonstrations related to health services research and quality measurement
and improvement activities undertaken and supported by the Federal
Government.
[<-Struck out]
`(2) SPECIFIC ACTIVITIES- The Director, in
collaboration with the appropriate Federal officials representing all
concerned executive agencies and departments, shall develop and manage a
process to--
[<-Struck out]
`(A) improve interagency coordination,
priority setting, and the use and sharing of research findings and data
pertaining to Federal quality improvement programs and health services
research;
[<-Struck out]
`(B) strengthen the research information
infrastructure, including databases, pertaining to Federal health services
research and healthcare quality improvement initiatives;
[<-Struck out]
`(C) set specific goals for participating
agencies and departments to further health services research and
healthcare quality improvement; and
[<-Struck out]
`(D) strengthen the management of Federal
healthcare quality improvement programs.
[<-Struck out]
`(b) STUDY BY THE INSTITUTE OF MEDICINE-
[<-Struck out]
`(1) IN GENERAL- To provide the Department of
Health and Human Services with an independent, external review of its
quality oversight, and quality research programs, the Secretary shall enter
into a contract with the Institute of Medicine--
[<-Struck
out]
`(A) to describe and evaluate current quality
improvement research and monitoring processes through--
[<-Struck out]
`(i) an overview of pertinent health
services research activities and quality improvement efforts including
those currently performed by the peer review organizations and the
exploration of additional activities that could be undertaken by the
peer review organizations to improve quality;
[<-Struck
out]
`(ii) an analysis of the various partnership
activities that the Department of Health and Human Services has pursued
[<-Struck out][Struck out->] with private sector accreditation and other quality
measurement organizations;
[<-Struck out]
`(iii) the exploration of programmatic areas
where partnership activities between the Federal Government and the
private sector or within the Federal Government could be pursued to
improve quality oversight of the medicare, medicaid and child health
insurance programs under titles XVIII, XIX and XXI of the Social
Security Act; and
[<-Struck out]
`(iv) an identification of opportunities for
enhancing health system efficiency through simplification and reduction
in redundancy of Federal agency quality improvement efforts, including
areas in which Federal efforts unnecessarily duplicate existing private
sector efforts; and
[<-Struck out]
`(B) to identify options and make
recommendations to improve the efficiency and effectiveness of such
quality improvement programs through--
[<-Struck out]
`(i) the improved coordination of activities
across the medicare, medicaid and child health insurance programs under
titles XVIII, XIX and XXI of the Social Security Act and various health
services research programs;
[<-Struck out]
`(ii) the strengthening of patient choice
and participation by incorporating state-of-the-art quality monitoring
tools and making information on quality available; and
[<-Struck out]
`(iii) the enhancement of the most effective
programs, consolidation as appropriate, and elimination of duplicative
activities within various federal agencies.
[<-Struck
out]
`(2) REQUIREMENTS-
[<-Struck
out]
`(A) IN GENERAL- The Secretary shall enter
into a contract with the Institute of Medicine for the preparation--
[<-Struck out]
`(i) not later than 12 months after the date
of enactment of this title, of a report providing an overview of the
quality improvement programs of the Department of Health and Human
Services for the medicare, medicaid, and CHIP programs under titles
XVIII, XIX, and XXI of the Social Security Act; and
[<-Struck
out]
`(ii) not later than 24 months after the
date of enactment of this title, of a final report containing
recommendations.
[<-Struck out]
`(B) REPORTS- The Secretary shall submit 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.
[<-Struck out]
`PART C--GENERAL PROVISIONS
[<-Struck
out]
`SEC. 921. ADVISORY COUNCIL FOR HEALTHCARE RESEARCH
AND QUALITY.
[<-Struck out]
`(a) ESTABLISHMENT- There is established an
advisory council to be known as the Advisory Council for Healthcare Research
and Quality.
[<-Struck out]
`(b) DUTIES-
[<-Struck out]
`(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).
[<-Struck out]
`(2) CERTAIN RECOMMENDATIONS- Activities of the
Advisory Council under paragraph (1) shall include making recommendations to
the Director regarding--
[<-Struck out]
`(A) priorities regarding healthcare research,
especially studies related to quality, outcomes, cost and the utilization
of, and access to, healthcare services;
[<-Struck out]
`(B) the field of healthcare research and
related disciplines, especially issues related to training needs, and
dissemination of information pertaining to healthcare quality; and
[<-Struck out]
`(C) the appropriate role of the Agency in
each of these areas in light of private sector activity and identification
of opportunities for public-private sector partnerships.
[<-Struck out]
`(c) MEMBERSHIP-
[<-Struck out]
`(1) IN GENERAL- The Advisory Council shall, in
accordance with this subsection, be composed of appointed 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.
[<-Struck out]
`(2) APPOINTED MEMBERS- The Secretary shall
appoint to the Advisory Council 21 appropriately qualified individuals. At
least 17 members of the Advisory Council shall be representatives of the
public who are not officers or employees of the United
[<-Struck
out][Struck out->] States. The Secretary shall ensure that the appointed
members 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--
[<-Struck
out]
`(A) 4 shall be individuals distinguished in
the conduct of research, demonstration projects, and evaluations with
respect to healthcare;
[<-Struck out]
`(B) 4 shall be individuals distinguished in
the practice of medicine of which at least 1 shall be a primary care
practitioner;
[<-Struck out]
`(C) 3 shall be individuals distinguished in
the other health professions;
[<-Struck out]
`(D) 4 shall be individuals either
representing the private healthcare sector, including health plans,
providers, and purchasers or individuals distinguished as administrators
of healthcare delivery systems;
[<-Struck out]
`(E) 4 shall be individuals distinguished in
the fields of healthcare quality improvement, economics, information
systems, law, ethics, business, or public policy; and
[<-Struck
out]
`(F) 2 shall be individuals representing the
interests of patients and consumers of healthcare.
[<-Struck
out]
`(3) EX OFFICIO MEMBERS- The Secretary shall
designate as ex officio members of the Advisory Council--
[<-Struck out]
`(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 Secretary of Defense (Health
Affairs), and the Chief Medical Officer of the Department of Veterans
Affairs; and
[<-Struck out]
`(B) such other Federal officials as the
Secretary may consider appropriate.
[<-Struck out]
`(d) TERMS- Members of the Advisory Council
appointed under subsection (c)(2) shall serve for a term of 3 years. A member
of the Council appointed under such subsection may continue to serve after the
expiration of the term of the members until a successor is appointed.
[<-Struck out]
`(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 appointed to fill the
resulting vacancy shall be appointed for the remainder of the term of the
predecessor of the individual.
[<-Struck out]
`(f) CHAIR- The Director shall, from among the
members of the Advisory Council appointed under subsection (c)(2), designate
an individual to serve as the chair of the Advisory Council.
[<-Struck out]
`(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.
[<-Struck out]
`(h) COMPENSATION AND REIMBURSEMENT OF EXPENSES-
[<-Struck out]
`(1) APPOINTED MEMBERS- Members of the Advisory
Council appointed under subsection (c)(2) shall receive compensation for
each day (including travel time) engaged in carrying out the duties of the
Advisory Council unless declined by the member. Such compensation may not be
in an amount in excess of the maximum rate of basic pay payable for GS-18 of
the General Schedule.
[<-Struck out]
`(2) EX OFFICIO MEMBERS- Officials designated
under subsection (c)(3) as ex officio members of the Advisory Council may
not receive compensation for service on the Advisory Council in addition to
the compensation otherwise received for duties carried out as officers of
the United States.
[<-Struck out]
`(i) STAFF- The Director shall provide to the
Advisory Council such staff, information, and other assistance as may be
necessary to carry out the duties of the Council.
[<-Struck out]
`SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND
CONTRACTS.
[<-Struck out]
`(a) REQUIREMENT OF REVIEW-
[<-Struck
out]
`(1) IN GENERAL- Appropriate technical and
scientific peer review shall be conducted with respect to each application
for a grant, cooperative agreement, or contract under this title.
[<-Struck out]
`(2) REPORTS TO DIRECTOR- Each peer review group
to which an application is submitted pursuant to paragraph (1) shall report
its finding and recommendations respecting the application to the Director
in such form and in such manner as the Director shall require.
[<-Struck out]
`(b) APPROVAL AS PRECONDITION OF AWARDS- The
Director may not approve an application described in subsection (a)(1) unless
the application is recommended for approval by a peer review group established
under subsection (c).
[<-Struck out]
`(c) ESTABLISHMENT OF PEER REVIEW GROUPS-
[<-Struck out]
`(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 provisions of title 5, United States Code, that govern appointments in
the competitive service, and without regard to the provisions of chapter 51,
and subchapter III of chapter 53, of such title that relate to
classification and pay rates under the General Schedule.
[<-Struck
out]
`(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. Officers 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 addition to the
compensation otherwise received for these duties carried out as such
officers and employees.
[<-Struck out]
`(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.
[<-Struck out]
`(4) QUALIFICATIONS- Members of any peer-review
group shall, at a minimum, meet the following requirements:
[<-Struck out]
`(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.
[<-Struck out]
`(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
appearance of such conflict, including employment in a directly affected
organization, stock ownership, or any financial or other arrangement that
might introduce bias in the process of peer-review.
[<-Struck
out]
`(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 procedures 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 individuals into the field of
research, for the purpose of encouraging clinical
[<-Struck out][Struck out->] practice-oriented or provider-based research, and for
such other purposes as the Director may determine to be appropriate.
[<-Struck out]
`(e) REGULATIONS- The Director may shall issue
regulations for the conduct of peer review under this section.
[<-Struck out]
`SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO
DEVELOPMENT, COLLECTION, AND DISSEMINATION OF DATA.
[<-Struck
out]
`(a) STANDARDS WITH RESPECT TO UTILITY OF DATA-
[<-Struck out]
`(1) IN GENERAL- To ensure the utility,
accuracy, and sufficiency of data collected by or for the Agency for the
purpose described in section 901(b), the Director shall establish standards
and methods for developing and collecting such data, taking into
consideration--
[<-Struck out]
`(A) other Federal health data collection
standards; and
[<-Struck out]
`(B) the differences between types of
healthcare plans, delivery systems, healthcare providers, and provider
arrangements.
[<-Struck out]
`(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 and
Human Services, including the programs under titles XVIII, XIX and XXI of
the Social Security Act, they shall be in the form of recommendations to the
Secretary for such program.
[<-Struck out]
`(b) STATISTICS AND ANALYSES- The Director shall--
[<-Struck out]
`(1) take appropriate action to ensure that
statistics and analyses developed under this title are of high quality,
timely, and duly comprehensive, and that the statistics are specific,
standardized, and adequately analyzed and indexed; and
[<-Struck
out]
`(2) publish, make available, and disseminate
such statistics and analyses on as wide a basis as is practicable.
[<-Struck out]
`(c) AUTHORITY REGARDING CERTAIN REQUESTS- Upon
request of a public or private entity, the Director may conduct or support
research or analyses otherwise authorized 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 expended.
[<-Struck
out]
`SEC. 924. DISSEMINATION OF INFORMATION.
[<-Struck out]
`(a) IN GENERAL- The Director shall--
[<-Struck out]
`(1) without regard to section 501 of title 44,
United States Code, promptly publish, make available, and otherwise
disseminate, in a form understandable and on as broad a basis as practicable
so as to maximize its use, the results of research, demonstration projects,
and evaluations conducted or supported under this title;
[<-Struck
out]
`(2) ensure that information disseminated by the
Agency is science-based and objective and undertakes consultation as
necessary to assess the appropriateness and usefulness of the presentation
of information that is targeted to specific audiences;
[<-Struck
out]
`(3) promptly make available to the public data
developed in such research, demonstration projects, and evaluations;
[<-Struck out]
`(4) provide, in collaboration with the National
Library of Medicine where appropriate, indexing, abstracting, 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 improved methods
for making such information available; and
[<-Struck out]
`(5) as appropriate, provide technical
assistance to State and local government and health agencies and conduct
liaison activities to such agencies to foster dissemination.
[<-Struck out]
`(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.
[<-Struck out]
`(c) LIMITATION ON USE OF CERTAIN INFORMATION- No
information, if an establishment or person supplying the information or
described in it is identifiable, obtained 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 establishment or person
has consented (as determined under regulations of the Secretary) 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 described in
it is identifiable unless such person has consented (as determined under
regulations of the Secretary) to its publication or release in other form.
[<-Struck out]
`(d) PENALTY- Any person who violates subsection
(c) shall be subject to a civil monetary penalty of not more 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.
[<-Struck
out]
`SEC. 925. ADDITIONAL PROVISIONS WITH RESPECT TO
GRANTS AND CONTRACTS.
[<-Struck out]
`(a) FINANCIAL CONFLICTS OF INTEREST- With respect
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--
[<-Struck out]
`(1) the specific circumstances that constitute
financial interests in such projects that will, or may be reasonably
expected to, create a bias in favor of obtaining results in the projects
that are consistent with such interests; and
[<-Struck out]
`(2) the actions that will be taken by the
Director in response to any such interests identified by the Director.
[<-Struck out]
`(b) REQUIREMENT OF APPLICATION- The Director may
not, with respect to any program under this title authorizing the provision of
grants, cooperative agreements, or contracts, provide any such financial
assistance unless an application for the assistance is submitted to the
Secretary and the application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the Director
determines to be necessary to carry out the program in involved.
[<-Struck out]
`(c) PROVISION OF SUPPLIES AND SERVICES IN LIEU OF
FUNDS-
[<-Struck out]
`(1) IN GENERAL- Upon the request of an entity
receiving a grant, cooperative agreement, or contract under this title, the
Secretary may, subject to paragraph (2), provide supplies, equipment, and
services 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 Department of Health and Human Services.
[<-Struck
out]
`(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 expenses incurred in complying with such request, expend the
amounts withheld.
[<-Struck out]
`(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).
[<-Struck out]
`SEC. 926. CERTAIN ADMINISTRATIVE AUTHORITIES.
[<-Struck out]
`(a) DEPUTY DIRECTOR AND OTHER OFFICERS AND
EMPLOYEES-
[<-Struck out]
`(1) DEPUTY DIRECTOR- The Director may appoint a
deputy director for the Agency.
[<-Struck out]
`(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 compensation fixed in accordance with title 5, United
States Code.
[<-Struck out]
`(b) FACILITIES- The Secretary, in carrying out
this title--
[<-Struck out]
`(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 Columbia for use
for a period not to exceed 10 years; and
[<-Struck out]
`(2) may acquire, construct, improve, repair,
operate, and maintain laboratory, research, and other necessary facilities
and equipment, and such other real or personal property (including patents)
as the Secretary deems necessary.
[<-Struck out]
`(c) PROVISION OF FINANCIAL ASSISTANCE- The
Director, 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.
[<-Struck out]
`(d) UTILIZATION OF CERTAIN PERSONNEL AND
RESOURCES-
[<-Struck out]
`(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 determined by the
Secretary) entities and individuals
[<-Struck out][Struck out->] to utilize the physical resources of such Department,
and provide technical assistance and advice.
[<-Struck out]
`(2) OTHER AGENCIES- The Director, in carrying
out this title, may use, with their consent, the services, equipment,
personnel, information, and facilities of other Federal, State, or local
public agencies, or of any foreign government, with or without reimbursement
of such agencies.
[<-Struck out]
`(e) CONSULTANTS- The Secretary, in carrying out
this title, may secure, from time to time and for such periods 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.
[<-Struck out]
`(f) EXPERTS-
[<-Struck out]
`(1) IN GENERAL- The Secretary may, in carrying
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 service shall not apply.
[<-Struck
out]
`(2) TRAVEL EXPENSES-
[<-Struck
out]
`(A) IN GENERAL- Experts and consultants whose
services are obtained under paragraph (1) shall be paid or reimbursed for
their expenses associated with traveling to and from their assignment
location in accordance with sections 5724, 5724a(a), 5724a(c), and 5726(C)
of title 5, United States Code.
[<-Struck out]
`(B) LIMITATION- Expenses specified in
subparagraph (A) may not be allowed in connection with the assignment of
an expert or consultant whose services are obtained under paragraph (1)
unless and until the expert agrees in writing to complete the entire
period of assignment, or 1 year, whichever is shorter, unless separated or
reassigned for reasons that are beyond the control of the expert or
consultant and that are acceptable to the Secretary. If the expert or
consultant violates the agreement, the money spent by the United States
for the expenses specified in subparagraph (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.
[<-Struck out]
`(g) VOLUNTARY AND UNCOMPENSATED SERVICES- The
Director, in carrying out this title, may accept voluntary and uncompensated
services.
[<-Struck out]
`SEC. 927. FUNDING.
[<-Struck out]
`(a) INTENT- To ensure that the United States's
investment 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 findings in daily practice. The authorization levels in subsections
(b) and (c) provide for a proportionate increase in healthcare research as the
United State's investment in biomedical research increases.
[<-Struck out]
`(b) AUTHORIZATION OF APPROPRIATIONS- For the
purpose of carrying out this title, there are authorized to be appropriated
$185,000,000 for fiscal year 2000, and such sums as may be necessary for each
of the fiscal years 2001 through 2006.
[<-Struck out]
`(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 evaluations), an amount equal to 40 percent of the
maximum amount authorized in such section 241 to be made available for a
fiscal year.
[<-Struck out]
`SEC. 929. DEFINITIONS.
[<-Struck
out]
`In this title:
[<-Struck out]
`(1) ADVISORY COUNCIL- The term `Advisory
Council' means the Advisory Council on Healthcare Research and Quality
established under section 921.
[<-Struck out]
`(2) AGENCY- The term `Agency' means the Agency
for Healthcare Research and Quality.
[<-Struck out]
`(3) DIRECTOR- The term `Director' means the
Director for the Agency for Healthcare Research and Quality.'.
[<-Struck out]
SEC. 403. REFERENCES.
[<-Struck out]
Effective upon the date of enactment of this Act,
any reference in law to the `Agency for Health Care Policy and Research' shall
be deemed to be a reference to the `Agency for Healthcare Research and
Quality'.
[<-Struck out]
SEC. 404. STUDY.
[<-Struck out]
(a) STUDY- Not later than 30 days after the date
of enactment of any Act providing for a qualifying health care benefit (as
defined in subsection (b)), the Secretary of Health and Human Services, in
consultation with the Agency for Healthcare Research and Quality, the National
Institutes of Health, and the Institute of Medicine, shall conduct a study
concerning such benefit that scientifically evaluates--
[<-Struck
out]
(1) the safety and efficacy of the benefit,
particularly the effect of the benefit on outcomes of care;
[<-Struck out]
(2) the cost, benefits and value of such
benefit;
[<-Struck out]
(3) the benefit in comparison to alternative
approaches in improving care; and
[<-Struck out]
(4) the overall impact that such benefit will
have on health care as measured through research.
[<-Struck
out]
(b) QUALIFYING HEALTH CARE BENEFIT- In this
section, the term `qualifying health care benefit' means a health care benefit
that--
[<-Struck out]
(1) is disease- or health condition-specific;
[<-Struck out]
(2) requires the provision of or coverage for
health care items or services;
[<-Struck out]
(3) applies to group health plan, individual
health plans, or health insurance issuers under part 7 of subtitle B of
title I of the Employee Retirement Income Security Act of 1974 (29 U.S.C.
1181 et seq.) or under title XXVII of the Public Health Service Act (42
U.S.C. 300gg et seq.); and
[<-Struck out]
(4) was provided under an Act (or amendment)
enacted on or after January 1, 1999.
[<-Struck out]
(c) REPORTS- Not later than 3 years after the date
of enactment of any Act described in subsection (a), the Secretary of Health
and Human Services shall prepare and submit to the appropriate committees of
Congress a report based on the study conducted under such subsection with
respect to the qualifying health care benefit involved.
[<-Struck
out]
TITLE V--MISCELLANEOUS PROVISIONS
[<-Struck out]
SEC. 501. SENSE OF THE COMMITTEE.
[<-Struck out]
It is the sense of the Committee on Health,
Education, Labor, and Pensions of the Senate that the Congress should take
measures to further the purposes of this Act, including any necessary changes
to the Internal Revenue Code of 1986 or to other Acts to--
[<-Struck
out]
(1) promote equity and prohibit discrimination
based on genetic information with respect to the availability of health
benefits;
[<-Struck out]
(2) provide for the full deduction of health
insurance costs for self-employed individuals;
[<-Struck
out]
(3) provide for the full availability of medical
savings accounts;
[<-Struck out]
(4) provide for the carryover of unused benefits
from cafeteria plans, flexible spending arrangements, and health flexible
spending accounts; and
[<-Struck out]
(5) permit contributions towards medical savings
account through the Federal employees health benefits program.
[<-Struck out]
this paragraph, the provisions of subparagraph (C) of section 712(c)(1) shall apply in determining employer size.
(other than a fully insured group health plan) to provide specific benefits under the terms of such plan.
for each package option available under a group health plan the following:
under subsection (b)(15) as part of the required information.
`Sec. 9813. Health plan comparative information.'; and
than 30 working days after the date on which a request for such appeal is received.
would take place, or the manufacturer of any drug, device, procedure, or other therapy proposed for the participant or beneficiary whose treatment is under review;
scope of his or her State licensure or certification for the delivery of health care services and who is primarily responsible for delivering those services to the participant or beneficiary.
Security Act of 1974 is amended by striking the item relating to section 503 and inserting the following new item:
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 community.
review of their quality oversight, quality improvement and quality research programs, the Secretary shall enter into a contract with the Institute of Medicine--
States. The Secretary shall ensure that the appointed members 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--
practice-oriented or provider-based research, and for such other purposes as the Director may determine to be appropriate.
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.
to utilize the physical resources of such Department, and provide technical assistance and advice.
to complete the entire period of assignment, or 1 year, whichever is shorter, unless separated or reassigned for reasons that are beyond the control of the expert or consultant and that are acceptable to the Secretary. If the expert or consultant violates the agreement, the money spent by the United States for the expenses specified in subparagraph (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.
END