2001CRS7262A TEXT OF AMENDMENTS, Part 1/4
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[Congressional Record: June 29, 2001 (Senate)]
[Page S7262-S7283]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]
[DOCID:cr29jn01-148]
TEXT OF AMENDMENTS
SA 850. Mr. NICKLES proposed an amendment to the bill S. 1052, to
amend the Public Health Service Act and the Employee Retirement Income
Security Act of 1974 to protect consumers in managed care plans and
other health coverage; as follows:
On page 131, after line 20, insert the following:
TITLE III--APPLICATION OF PATIENT PROTECTION STANDARDS TO FEDERAL
HEALTH CARE PROGRAMS
SEC. 301. APPLICATION OF PATIENT PROTECTION STANDARDS TO
FEDERAL HEALTH CARE PROGRAMS.
(a) Application of Standards.--
(1) In general.--Each Federal health care program shall
comply with the patient protection requirements under title
I, and such requirements shall be deemed to be incorporated
into this section.
(2) Cause of action relating to provision of health
benefits.--Any individual who receives a health care item or
service under a Federal health care program shall have a
cause of action against the Federal Government under sections
502(n) and 514(d) of the Employee Retirement Income Security
Act of 1974, and the provisions of such sections shall be
deemed to be incorporated into this section.
(3) Rules of construction.--For purposes of this
subsection--
(A) each Federal health care program shall be deemed to be
a group health plan;
(B) the Federal Government shall be deemed to be the plan
sponsor of each Federal health care program; and
(C) each individual eligible for benefits under a Federal
health care program shall be deemed to be a participant,
beneficiary, or enrollee under that program.
(b) Federal Health Care Program Defined.--In this section,
the term ``Federal health care program'' has the meaning
given that term under section 1128B(f) of the Social Security
Act (42 U.S.C. 1320a-7b) except that, for purposes of this
section, such term includes the Federal employees health
benefits program established under chapter 89 of title 5,
United States Code.
____
SA 851. Mr. CRAIG proposed an amendment to the bill S. 1052, to amend
the Public Health Service Act and the Employee Retirement Income
Security Act of 1974 to protect consumers in managed care plans and
other health coverage, as follows:
At the appropriate place insert the following:
SEC. . SENSE OF THE SENATE REGARDING FULL AVAILABILITY OF
MEDICAL SAVINGS ACCOUNTS.
(a) Findings.--The Senate finds:
(1) Medical savings accounts eliminate bureaucracy and put
patients in control of their health care decisions.
(2) Medical savings accounts extend coverage to the
uninsured. According to the Treasury Department, one-third of
MSA purchasers previously had no health care coverage.
(3) The medical savings account demonstration program has
been hampered with restrictions that put medical savings
accounts out of reach for millions of Americans.
(b) Sense of the Senate.--It is the sense of the Senate
that a patients' bill of rights should remove the
restrictions on the private-sector medical savings account
demonstration program to make medical savings accounts
available to more Americans.
____
SA 852. Mr. REID proposed an amendment to the bill S. 1052, to amend
the Public Health Service Act and the Employee Retirement Income
Security Act of 1974 to protect consumers in managed care plans and
other health coverage; as follows:
On page 154, between lines 2 and 3, insert the following:
``(11) Limitation on award of attorneys' fees.--
``(A) In general.--Subject to subparagraph (B), with
respect to a participant or beneficiary (or the estate of
such participant or beneficiary) who brings a cause of action
under this subsection and prevails in that action, the amount
of attorneys' contingency fees that a court may award to such
participant, beneficiary, or estate under subsection
[[Page S7263]]
(g)(1) (not including the reimbursement of actual out-of-
pocket expenses of an attorney as approved by the court in
such action) may not exceed an amount equal to \1/3\ of the
amount of the recovery.
``(B) Equitable discretion.--A court in its discretion may
adjust the amount of an award of attorneys' fees required
under subparagraph (A) as equity and the interests of justice
may require.
On page 170, between lines 21 and 22, insert the following:
``(9) Limitation on attorneys' fees.--
``(A) In general.--Notwithstanding any other provision of
law, or any arrangement, agreement, or contract regarding
attorneys' contingency fees, subject to subparagraph (B), a
court shall limit the amount of attorneys' fees that may be
incurred for the representation of a participant or
beneficiary (or the estate of such participant or
beneficiary) who brings a cause of action under paragraph (1)
to the amount of attorneys' fees that may be awarded under
section 502(n)(11).
``(B) Equitable discretion.--A court in its discretion may
adjust the amount of attorneys' fees allowed under
subparagraph (A) as equity and the interests of justice may
require.
____
SA 853. Mr. THOMPSON proposed an amendment to the bill S. 1052, to
amend the Public Health Service Act and the Employee Retirement Income
Security Act of 1974 to protect consumers in managed care plans and
other health coverage; as follows:
On page 170, between lines 21 and 22, insert the following:
``(9) Choice of law.--A cause of action brought under
paragraph (1) shall be governed by the law (including choice
of law rules) of the State in which the plaintiff resides.
____
SA 854. Mr. KYL (for himself and Mr. Nickles) proposed an amendment
to the bill S. 1052, to amend the Public Health Service Act and the
Employee Retirement Income Security Act of 1974 to protect consumers in
managed care plans and other health coverage; as follows:
On page 156, between lines 15 and 16, insert the following:
``(17) Damages options.--
``(A) In general.--In addition to plans or coverage that
are subject to this Act, a plan or issuer may offer, and a
participant or beneficiary may accept, a plan or coverage
that provides for one or more of the following remedies, in
which case the damages authorized by this section shall not
apply:
``(i) Equitable relief as provided for in subsection
(a)(1)(B).
``(ii) Unlimited economic damages, including reasonable
attorneys fees.
``(B) Protection of the regulation of quality of medical
care under state law.--Nothing in this paragraph shall be
construed to preclude any action under State law against a
person or entity for liability or vicarious liability with
respect to the delivery of medical care. A claim that is
based on or otherwise relates to a group health plan's
administration or determination of a claim for benefits
(notwithstanding the definition contained in paragraph (2))
shall not be deemed to be the delivery of medical care under
any State law for purposes of this section. Any such claim
shall be maintained exclusively under this section.''.
On page 170, between lines 21 and 22, insert the following:
``(9) Damages options.--
``(A) In general.--In addition to plans or coverage that
are subject to this Act, a plan or issuer may offer, and a
participant or beneficiary may accept, a plan or coverage
that provides for one or more of the following remedies, in
which case the damages authorized by this section shall not
apply:
``(i) Equitable relief as provided for in section
502(a)(1)(B).
``(ii) Unlimited economic damages, including reasonable
attorneys fees.
``(B) Protection of the regulation of quality of medical
care under state law.--Nothing in this paragraph shall be
construed to preclude any action under State law against a
person or entity for liability or vicarious liability with
respect to the delivery of medical care. A claim that is
based on or otherwise relates to a group health plan's
administration or determination of a claim for benefits
(notwithstanding the definition contained in section
502(n)(2)) shall not be deemed to be the delivery of medical
care under any State law for purposes of this section. Any
such claim shall be maintained exclusively under section 502.
____
SA 855. Mr. CARPER proposed an amendment to the bill S. 1052, to
amend the Public Health Service Act and the Employee Retirement Income
Security Act of 1974 to protect consumers in managed care plans and
other health coverage; as follows:
On page 153, strike line 9 and all that follows through
page 154, line 2, and insert the following:
``(10) Statutory damages.--The remedies set forth in this
subsection shall be the exclusive remedies for any cause of
action brought under this subsection. Such remedies shall
include economic and noneconomic damages, but shall not
include any punitive damages.
____
SA 856. Mr. FRIST (for himself and Mr. Breaux) proposed an amendment
to the bill S. 1052, to amend the Public Health Service Act and the
Employee Retirement Income Security Act of 1974 to protect consumers in
managed care plans and other health coverage; as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Bipartisan
Patients' Bill of Rights Act of 2001''.
(b) Table of Contents.--The table of contents of this Act
is as follows:
Sec. 1. Short title; table of contents.
TITLE I--PATIENTS' BILL OF RIGHTS
Subtitle A--Right to Advice and Care
Sec. 101. Access to emergency medical care.
Sec. 102. Offering of choice of coverage options.
Sec. 103. Patient access to obstetric and gynecological care.
Sec. 104. Access to pediatric care.
Sec. 105. Timely access to specialists.
Sec. 106. Continuity of care.
Sec. 107. Protection of patient-provider communications.
Sec. 108. Patient's right to prescription drugs.
Sec. 109. Coverage for individuals participating in approved clinical
trials.
Sec. 110. Required coverage for minimum hospital stay for mastectomies
and lymph node dissections for the treatment of breast
cancer and coverage for secondary consultations.
Sec. 111. Prohibition of discrimination against providers based on
licensure.
Sec. 112. Generally applicable provision.
Subtitle B--Right to Information About Plans and Providers
Sec. 121. Health plan information.
Sec. 122. Information about providers.
Sec. 123. Study on the effect of physician compensation methods.
Subtitle C--Right to Hold Health Plans Accountable
Sec. 131. Amendments to Employee Retirement Income Security Act of
1974.
Sec. 132. Enforcement.
Subtitle D--Remedies
Sec. 141. Availability of court remedies.
Subtitle E--State Flexibility
Sec. 151. Preemption; State flexibility; construction.
Sec. 152. Coverage of limited scope dental plans.
Subtitle F--Miscellaneous Provisions
Sec. 161. Definitions.
TITLE II--AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT
Sec. 201. Application to certain health insurance coverage.
Sec. 202. Application to individual health insurance coverage.
Sec. 203. Limitation on authority of the Secretary of Health and Human
services with respect to non-Federal governmental plans.
Sec. 204. Cooperation between Federal and State authorities.
TITLE III--AMENDMENTS TO THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF
1974
Sec. 301. Application of patient protection standards to group health
plans and group health insurance coverage under the
Employee Retirement Income Security Act of 1974.
Sec. 302. Cooperation between Federal and State authorities.
TITLE IV--AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986
Sec. 401. Application to group health plans under the Internal Revenue
Code of 1986.
Sec. 402. Conforming enforcement for women's health and cancer rights.
TITLE V--EFFECTIVE DATE; SEVERABILITY
Sec. 501. Effective date and related rules.
Sec. 502. Severability.
Sec. 503. Annual review.
TITLE I--PATIENTS' BILL OF RIGHTS
Subtitle A--Right to Advice and Care
SEC. 101. ACCESS TO EMERGENCY MEDICAL CARE.
(a) Coverage of Emergency Services.--If a group health
plan, and a health insurance issuer that offers health
insurance coverage, provides coverage for any benefits
consisting of emergency medical care, except for items or
services specifically excluded from coverage, the plan or
issuer shall, without regard to prior authorization or
provider participation--
(1) provide coverage for emergency medical screening
examinations to the extent that a prudent layperson, who
possesses an average knowledge of health and medicine, would
determine such examinations to be necessary; and
(2) provide coverage for additional emergency medical care
to stabilize an emergency medical condition following an
emergency medical screening examination (if determined
necessary), pursuant to the definition of stabilize under
section 1867(e)(3) of
[[Page S7264]]
the Social Security Act (42 U.S.C. 1395dd(e)(3)).
(b) Coverage of Emergency Ambulance Services.--If a group
health plan, and a health insurance issuer that offers health
insurance coverage, provides coverage for any benefits
consisting of emergency ambulance services, except for items
or services specifically excluded from coverage, the plan or
issuer shall, without regard to prior authorization or
provider participation, provide coverage for emergency
ambulance services to the extent that a prudent layperson,
who possesses an average knowledge of health and medicine,
would determine such emergency ambulance services to be
necessary.
(c) Care After Stabilization.--
(1) In general.--In the case of medically necessary and
appropriate items or services related to the emergency
medical condition that may be provided to a participant,
beneficiary, or enrollee by a nonparticipating provider after
the participant, beneficiary, or enrollee is stabilized, the
nonparticipating provider shall contact the plan or issuer as
soon as practicable, but not later than 1 hour after
stabilization occurs, with respect to whether--
(A) the provision of items or services is approved;
(B) the participant, beneficiary, or enrollee will be
transferred; or
(C) other arrangements will be made concerning the care and
treatment of the participant, beneficiary, or enrollee.
(2) Failure to respond and make arrangements.--If a group
health plan, and a health insurance issuer that offers health
insurance coverage, fails to respond and make arrangements
within 1 hour of being contacted in accordance with paragraph
(1), then the plan or issuer shall be responsible for the
cost of any additional items or services provided by the
nonparticipating provider if--
(A) coverage for items or services of the type furnished by
the nonparticipating provider is available under the plan or
coverage;
(B) the items or services are medically necessary and
appropriate and related to the emergency medical condition
involved; and
(C) the timely provision of the items or services is
medically necessary and appropriate.
(3) Rule of construction.--Nothing in this subsection shall
be construed to apply to a group health plan, and a health
insurance issuer that offers health insurance coverage, that
does not require prior authorization for items or services
provided to a participant, beneficiary, or enrollee after the
participant, beneficiary, or enrollee is stabilized.
(d) Reimbursement to a Nonparticipating Provider.--The
responsibility of a group health plan, and a health insurance
issuer that offers health insurance coverage, to provide
reimbursement to a nonparticipating provider under this
section shall cease accruing upon the earlier of--
(1) the transfer or discharge of the participant,
beneficiary, or enrollee; or
(2) the completion of other arrangements made by the plan
or issuer and the nonparticipating provider.
(e) Responsibility of Participant.--The coverage required
under subsections (a), (b), and (c) shall be provided by a
group health plan, and a health insurance issuer that offers
health insurance coverage, in a manner so that, if the
services referred to in such subsections are provided to a
participant, beneficiary, or enrollee by a nonparticipating
provider with or without prior authorization, the
participant, beneficiary, or enrollee is not liable for
amounts that exceed the amounts of liability that would be
incurred if the services were provided by a participating
health care provider with prior authorization.
(f) Rule of Construction.--Nothing in this section shall be
construed to prohibit a group health plan or health insurance
issuer from negotiating reimbursement rates with a
nonparticipating provider for items or services provided
under this section.
(g) Definitions.--In this section:
(1) Emergency ambulance services.--The term ``emergency
ambulance services'' means, with respect to a participant,
beneficiary, or enrollee under a group health plan, or a
health insurance issuer that offers health insurance
coverage, ambulance services furnished to transport an
individual who has an emergency medical condition to a
treating facility for receipt of emergency medical care if--
(A) the emergency services are covered under the group
health plan or health insurance coverage involved; and
(B) a prudent layperson who possesses an average knowledge
of health and medicine could reasonably expect the absence of
such emergency transport to result in placing the health of
the participant, beneficiary, or enrollee (or, with respect
to a pregnant woman, the health of the woman or her unborn
child) in serious jeopardy, serious impairment to bodily
functions, or serious dysfunction of any bodily organ or
part.
(2) Emergency medical care.--The term ``emergency medical
care'' means, with respect to a participant, beneficiary, or
enrollee under a group health plan, or a health insurance
issuer that offers health insurance coverage, covered
inpatient and outpatient items or services that--
(A) are furnished by any provider, including a
nonparticipating provider, that is qualified to furnish such
items or services; and
(B) are needed to evaluate or stabilize (as such term is
defined in section 1867(e)(3) of the Social Security Act (42
U.S.C. 1395dd(e)(3)) an emergency medical condition.
(3) 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 placing the health of the participant, beneficiary, or
enrollee (or, with respect to a pregnant woman, the health of
the woman or her unborn child) in serious jeopardy, serious
impairment to bodily functions, or serious dysfunction of any
bodily organ or part.
SEC. 102. OFFERING OF CHOICE OF COVERAGE OPTIONS.
(a) Requirement.--If a 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.
(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 coverage of such
benefits when provided by a nonparticipating health care
professional.
(c) Small Employer Exemption.--
(1) In general.--This section shall not apply to any group
health plan with respect to a small employer.
(2) Small employer.--For purposes of paragraph (1), the
term ``small employer'' means, in connection with a 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 25 employees on business days during the preceding
calendar year and who employs at least 2 employees on the
first day of the plan year. For purposes of this paragraph,
the provisions of subparagraph (C) of section 712(c)(1) shall
apply in determining employer size.
(d) Rule of Construction.--Nothing in this section shall be
construed--
(1) as requiring coverage for benefits for a particular
type of health care professional;
(2) as preventing a group health plan from imposing higher
premiums or cost-sharing on a participant for the exercise of
a point-of-service coverage option; or
(3) to require that a 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.
(e) Special Point of Service Protection for Individuals in
Dental Plans.--For purposes of applying the requirements of
this section under sections 2707 and 2753 of the Public
Health Service Act and section 714 of the Employee Retirement
Income Security Act of 1974, section 2791(c)(2)(A) of the
Public Health Service Act and section 733(c)(2)(A) of the
Employee Retirement Income Security Act of 1974, only
relating to limited scope dental benefits, shall be deemed
not to apply.
SEC. 103. PATIENT ACCESS TO OBSTETRIC AND GYNECOLOGICAL CARE.
(a) General Rights.--
(1) Direct access.--A group health plan, and a health
insurance issuer that offers health insurance coverage,
described in subsection (b) may not require authorization or
referral by the primary care provider described in subsection
(b)(2) in the case of a female participant, beneficiary, or
enrollee who seeks coverage for obstetrical or gynecological
care provided by a participating physician who specializes in
obstetrics or gynecology.
(2) Obstetrical and gynecological care.--A group health
plan, and a health insurance issuer that offers health
insurance coverage, described in subsection (b) shall treat
the provision of obstetrical and gynecological care, and the
ordering of related obstetrical and gynecological items and
services, pursuant to the direct access described under
paragraph (1), by a participating health care professional
who specializes in obstetrics or gynecology as the
authorization of the primary care provider.
(b) Application of Section.--A group health plan, and a
health insurance issuer that offers health insurance
coverage, described in this subsection is a plan or issuer,
that--
(1) provides coverage for obstetric or gynecologic care;
and
(2) requires the designation by a participant, beneficiary,
or enrollee of a participating primary care provider other
than a physician who specializes in obstetrics or gynecology.
(c) Rules of Construction.--Nothing in this section shall
be construed--
(1) to require that a group health plan or a health
insurance issuer approve or provide coverage for--
(A) any items or services that are not covered under the
terms and conditions of the plan or coverage;
(B) any items or services that are not medically necessary
and appropriate; or
(C) any items or services that are provided, ordered, or
otherwise authorized under subsection (a)(2) by a physician
unless such items or services are related to obstetric or
gynecologic care;
[[Page S7265]]
(2) to preclude a group health plan or health insurance
issuer from requiring that the physician described in
subsection (a) notify the designated primary care
professional or case manager of treatment decisions in
accordance with a process implemented by the plan or issuer,
except that the plan or issuer shall not impose such a
notification requirement on the participant, beneficiary, or
enrollee involved in the treatment decision;
(3) to preclude a group health plan or health insurance
issuer from requiring authorization, including prior
authorization, for certain items and services from the
physician described in subsection (a) who specializes in
obstetrics and gynecology if the designated primary care
provider of the participant, beneficiary, or enrollee would
otherwise be required to obtain authorization for such items
or services;
(4) to require that the participant, beneficiary, or
enrollee described in subsection (a)(1) obtain authorization
or a referral from a primary care provider in order to obtain
obstetrical or gynecological care from a health care
professional other than a physician if the provision of
obstetrical or gynecological care by such professional is
permitted by the group health plan or health insurance
coverage and consistent with State licensure, credentialing,
and scope of practice laws and regulations; or
(5) to preclude the participant, beneficiary, or enrollee
described in subsection (a)(1) from designating a health care
professional other than a physician as a primary care
provider if such designation is permitted by the group health
plan or health insurance issuer and the treatment by such
professional is consistent with State licensure,
credentialing, and scope of practice laws and regulations.
SEC. 104. ACCESS TO PEDIATRIC CARE.
(a) Pediatric Care.--If a group health plan, and a health
insurance issuer that offers health insurance coverage,
requires or provides for a participant, beneficiary, or
enrollee to designate a participating primary care provider
for a child of such participant, beneficiary, or enrollee,
the plan or issuer shall permit the participant, beneficiary,
or enrollee to designate a physician who specializes in
pediatrics as the child's primary care provider if such
provider participates in the network of the plan or issuer.
(b) Rules of Construction.--With respect to the child of a
participant, beneficiary, or enrollee, nothing in subsection
(a) shall be construed to--
(1) require that the participant, beneficiary, or enrollee
obtain prior authorization or a referral from a primary care
provider in order to obtain pediatric care from a health care
professional other than a physician if the provision of
pediatric care by such professional is permitted by the plan
or issuer and consistent with State licensure, credentialing,
and scope of practice laws and regulations; or
(2) preclude the participant, beneficiary, or enrollee from
designating a health care professional other than a physician
as a primary care provider for the child if such designation
is permitted by the plan or issuer and the treatment by such
professional is consistent with State licensure,
credentialing, and scope of practice laws.
SEC. 105. TIMELY ACCESS TO SPECIALISTS.
(a) Timely Access.--
(1) Requirement of coverage.--
(A) In general.--A group health plan, and a health
insurance issuer that offers health insurance coverage, shall
ensure that participants, beneficiaries, and enrollees
receive timely coverage for access to appropriate medical
specialists when such specialty care is a covered benefit
under the plan or coverage.
(B) Appropriate medical specialist defined.--In this
subsection, the term ``appropriate medical specialist'' means
a physician (including an alleopathic or osteopathic
physician) or health care professional who is appropriately
credentialed or licensed in 1 or more States and who
typically treats the diagnosis or condition of the
participant, beneficiary, or enrollee.
(2) Rule of construction.--Nothing in paragraph (1) shall
be construed--
(A) to require the coverage under a group health plan, or
health insurance coverage, of benefits or services;
(B) to prohibit a plan or health insurance issuer from
including providers in the network only to the extent
necessary to meet the needs of the plan's or issuer's
participants, beneficiaries, or enrollees;
(C) to prohibit a plan or issuer from establishing measures
designed to maintain quality and control costs consistent
with the responsibilities of the plan or issuer; or
(D) to override any State licensure or scope-of-practice
law.
(3) Access to certain providers.--
(A) Participating providers.--Nothing in this section shall
be construed to prohibit a group health plan, or a health
insurance issuer that offers health insurance coverage, from
requiring that a participant, beneficiary, or enrollee obtain
specialty care from a participating specialist.
(B) Nonparticipating providers.--
(i) In general.--With respect to specialty care under this
section, if a group health plan, or a health insurance issuer
that offers health insurance coverage, determines that a
participating specialist is not available to provide such
care to the participant, beneficiary, or enrollee, the plan
or issuer shall provide for coverage of such care by a
nonparticipating specialist.
(ii) Treatment of nonparticipating providers.--If a group
health plan, or a health insurance issuer that offers health
insurance coverage, refers a participant, beneficiary, or
enrollee to a nonparticipating specialist pursuant to clause
(i), such specialty care shall be provided at no additional
cost to the participant, beneficiary, or enrollee beyond what
the participant, beneficiary, or enrollee would otherwise pay
for such specialty care if provided by a participating
specialist.
(b) Referrals.--
(1) Authorization.--Nothing in this section shall be
construed to prohibit a group health plan, or a health
insurance issuer that offers health insurance coverage, from
requiring an authorization in order to obtain coverage for
specialty services so long as such authorization is for an
appropriate duration or number of referrals.
(2) Referrals for ongoing special conditions.--
(A) In general.--A group health plan, and a health
insurance issuer that offers health insurance coverage, shall
permit a participant, beneficiary, or enrollee who has an
ongoing special condition (as defined in subparagraph (B)) to
receive a referral to a specialist for the treatment of such
condition and such specialist may authorize such referrals,
procedures, tests, and other medical services with respect to
such condition, or coordinate the care for such condition,
subject to the terms of a treatment plan referred to in
subsection (c) with respect to the condition.
(B) Ongoing special condition defined.--In this subsection,
the term ``ongoing special condition'' means a condition or
disease that--
(i) is life-threatening, degenerative, or disabling; and
(ii) requires specialized medical care over a prolonged
period of time.
(c) Treatment Plans.--
(1) In general.--Nothing in this section shall be construed
to prohibit a group health plan, or a health insurance issuer
that offers health insurance coverage, from requiring that
specialty care be provided pursuant to a treatment plan so
long as the treatment plan is--
(A) developed by the specialist, in consultation with the
case manager or primary care provider, and the participant,
beneficiary, or enrollee; and
(B) if the plan or issuer requires such approval, approved
in a timely manner by the plan or issuer consistent with the
applicable quality assurance and utilization review standards
of the plan or issuer.
(2) Notification.--Nothing in paragraph (1) shall be
construed as prohibiting a plan or issuer from requiring the
specialist to provide the plan or issuer with regular updates
on the specialty care provided, as well as all other
necessary medical information.
(d) Specialist Defined.--For purposes of this section, the
term ``specialist'' means, with respect to the medical
condition of the participant, beneficiary, or enrollee, a
health care professional, facility, or center (such as a
center of excellence) that has adequate expertise (including
age-appropriate expertise) through appropriate training and
experience.
SEC. 106. CONTINUITY OF CARE.
(a) Termination of Provider.--If a contract between a group
health plan, and a health insurance issuer that offers health
insurance coverage, and a treating health care provider is
terminated (as defined in paragraph (e)(4)), or benefits or
coverage provided by a health care provider are terminated
because of a change in the terms of provider participation in
such plan or coverage, and an individual who is a
participant, beneficiary or enrollee under such plan or
coverage is undergoing an active course of treatment for a
serious and complex condition, institutional care, pregnancy,
or terminal illness from the provider at the time the plan or
issuer receives or provides notice of such termination, the
plan or issuer shall--
(1) notify the individual, or arrange to have the
individual notified pursuant to subsection (d)(2), on a
timely basis of such termination;
(2) provide the individual with an opportunity to notify
the plan or issuer of the individual's need for transitional
care; and
(3) subject to subsection (c), permit the individual to
elect to continue to be covered with respect to the active
course of treatment with the provider's consent during a
transitional period (as provided for under subsection (b)).
(b) Transitional Period.--
(1) Serious and complex conditions.--The transitional
period under this section with respect to a serious and
complex condition shall extend for up to 90 days from the
date of the notice described in subsection (a)(1) of the
provider's termination.
(2) Institutional or inpatient care.--
(A) In general.--The transitional period under this section
for institutional or non-elective inpatient care from a
provider shall extend until the earlier of--
(i) the expiration of the 90-day period beginning on the
date on which the notice described in subsection (a)(1) of
the provider's termination is provided; or
(ii) the date of discharge of the individual from such care
or the termination of the period of institutionalization.
(B) Scheduled care.--The 90 day limitation described in
subparagraph (A)(i) shall include post-surgical follow-up
care relating
[[Page S7266]]
to non-elective surgery that has been scheduled before the
date of the notice of the termination of the provider under
subsection (a)(1).
(3) Pregnancy.--If--
(A) a participant, beneficiary, or enrollee has entered the
second trimester of pregnancy at the time of a provider's
termination of participation; and
(B) the provider was treating the pregnancy before the date
of the termination;
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.
(4) Terminal illness.--If--
(A) a participant, beneficiary, or enrollee was determined
to be terminally ill (as determined under section
1861(dd)(3)(A) of the Social Security Act) at the time of a
provider's termination of participation; and
(B) the provider was treating the terminal illness before
the date of termination;
the transitional period under this subsection shall extend
for the remainder of the individual's life for care that is
directly related to the treatment of the terminal illness.
(c) Permissible Terms and Conditions.--A group health plan,
and a health insurance issuer that offers health insurance
coverage, may condition coverage of continued treatment by a
provider under this section upon the provider agreeing to the
following terms and conditions:
(1) The treating health care provider agrees to accept
reimbursement from the plan or issuer and individual involved
(with respect to cost-sharing) at the rates applicable prior
to the start of the transitional period as payment in full
(or at the rates applicable under the replacement plan after
the date of the termination of the contract with the plan or
issuer) 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
this section had not been terminated.
(2) The treating health care provider agrees to adhere to
the quality assurance standards of the plan or issuer
responsible for payment under paragraph (1) and to provide to
such plan or issuer necessary medical information related to
the care provided.
(3) The treating health care provider agrees otherwise to
adhere to such plan's or issuer'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 or issuer.
(d) Rules of Construction.--Nothing in this section shall
be construed--
(1) to require the coverage of benefits which would not
have been covered if the provider involved remained a
participating provider; or
(2) with respect to the termination of a contract under
subsection (a) to prevent a group health plan or health
insurance issuer from requiring that the health care
provider--
(A) notify participants, beneficiaries, or enrollees of
their rights under this section; or
(B) provide the plan or issuer with the name of each
participant, beneficiary, or enrollee who the provider
believes is eligible for transitional care under this
section.
(e) Definitions.--In this section:
(1) Contract.--The term ``contract between a group health
plan, and a health insurance issuer that offers health
insurance coverage, and a treating health care provider''
shall include a contract between such a plan or issuer and an
organized network of providers.
(2) Health care provider.--The term ``health care
provider'' or ``provider'' means--
(A) 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
(B) 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.
(3) Serious and complex condition.--The term ``serious and
complex condition'' means, with respect to a participant,
beneficiary, or enrollee under the plan or coverage, a
condition that is medically determinable and--
(A) in the case of an acute illness, is a condition serious
enough to require specialized medical treatment to avoid the
reasonable possibility of death or permanent harm; or
(B) in the case of a chronic illness or condition, is an
illness or condition that--
(i) is complex and difficult to manage;
(ii) is disabling or life- threatening; and
(iii) requires--
(I) frequent monitoring over a prolonged period of time and
requires substantial on-going specialized medical care; or
(II) frequent ongoing specialized medical care across a
variety of domains of care.
(4) Terminated.--The term ``terminated'' includes, with
respect to a contract (as defined in paragraph (1)), the
expiration or nonrenewal of the contract by the group health
plan or health insurance issuer, but does not include a
termination of the contract by the plan or issuer for failure
to meet applicable quality standards or for fraud.
SEC. 107. PROTECTION OF PATIENT-PROVIDER COMMUNICATIONS.
(a) In General.--Subject to subsection (b), a group health
plan, and a health insurance issuer that offers health
insurance coverage, (in relation to a participant,
beneficiary, or enrollee) shall not prohibit or otherwise
restrict a health care professional from advising such a
participant, beneficiary, or enrollee who is a patient of the
professional about the health status of the participant,
beneficiary, or enrollee or medical care or treatment for the
condition or disease of the participant, beneficiary, or
enrollee, 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.
(b) Rule of Construction.--Nothing in this section shall be
construed as requiring a group health plan, or a health
insurance issuer that offers health insurance coverage, to
provide specific benefits under the terms of such plan or
coverage.
SEC. 108. PATIENT'S RIGHT TO PRESCRIPTION DRUGS.
(a) In General.--To the extent that a group health plan,
and a health insurance issuer that offers health insurance
coverage, provides coverage for benefits with respect to
prescription drugs, and limits such coverage to drugs
included in a formulary, the plan or issuer shall--
(1) ensure the participation of physicians and pharmacists
in developing and reviewing such formulary; and
(2) in accordance with the applicable quality assurance and
utilization review standards of the plan or issuer, provide
for exceptions from the formulary limitation when a non-
formulary alternative is medically necessary and appropriate.
(b) Rule of Construction.--Nothing in this section shall be
construed to prohibit a group health plan, or a health
insurance issuer that offers health insurance coverage, from
excluding coverage for a specific drug or class of drugs if
such drugs or class of drugs is expressly excluded under the
terms and conditions of the plan or coverage.
SEC. 109. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED
CLINICAL TRIALS.
(a) Coverage.--
(1) In general.--If a group health plan, and a health
insurance issuer that offers health insurance coverage,
provides coverage to a qualified individual (as defined in
subsection (b)), the plan or issuer--
(A) may not deny the individual participation in the
clinical trial referred to in subsection (b)(2);
(B) subject to subsections (b), (c), and (d) may not deny
(or limit or impose additional conditions on) the coverage of
routine patient costs for items and services furnished in
connection with participation in the trial; and
(C) may not discriminate against the individual on the
basis of the participant's, beneficiaries, or enrollee's
participation in such trial.
(2) Exclusion of certain costs.--For purposes of paragraph
(1)(B), routine patient costs do not include the cost of the
tests or measurements conducted primarily for the purpose of
the clinical trial involved.
(3) Use of in-network providers.--If one or more
participating providers is participating in a clinical trial,
nothing in paragraph (1) shall be construed as preventing a
plan or issuer from requiring that a qualified individual
participate in the trial through such a participating
provider if the provider will accept the individual as a
participant in the trial.
(b) Qualified Individual Defined.--For purposes of
subsection (a), the term ``qualified individual'' means an
individual who is a participant or beneficiary in a group
health plan or an enrollee in health insurance coverage and
who meets the following conditions:
(1)(A) The individual has a life-threatening or serious
illness for which no standard treatment is effective.
(B) The individual is eligible to participate in an
approved clinical trial according to the trial protocol with
respect to treatment of such illness.
(C) The individual's participation in the trial offers
meaningful potential for significant clinical benefit for the
individual.
(2) Either--
(A) the referring physician is a participating health care
professional and has concluded that the individual's
participation in such trial would be appropriate based upon
the individual meeting the conditions described in paragraph
(1); or
(B) the participant, beneficiary, or enrollee provides
medical and scientific information establishing that the
individual's participation in such trial would be appropriate
based upon the individual meeting the conditions described in
paragraph (1).
(c) Payment.--
(1) In general.--Under this section a group health plan,
and a health insurance issuer that offers health insurance
coverage, shall provide for payment for routine patient costs
described in subsection (a)(2) but is not required to pay for
costs of items and services that are reasonably expected to
be paid for by the sponsors of an approved clinical trial.
(2) Standards for determining routine patient costs
associated with clinical trial participation.--
(A) In general.--The Secretary shall, in accordance with
this paragraph, establish standards relating to the coverage
of routine patient costs for individuals participating in
[[Page S7267]]
clinical trials that group health plans and health insurance
issuers must meet under this section.
(B) Factors.--In establishing routine patient cost
standards under subparagraph (A), the Secretary shall consult
with interested parties and take into account --
(i) quality of patient care;
(ii) routine patient care costs versus costs associated
with the conduct of clinical trials, including unanticipated
patient care costs as a result of participation in clinical
trials; and
(iii) previous and on-going studies relating to patient
care costs associated with participation in clinical trials.
(C) Appointment and meetings of negotiated rulemaking
committee.--
(i) Publication of notice.--Not later than November 15,
2002, the Secretary shall publish notice of the establishment
of a negotiated rulemaking committee, as provided for under
section 564(a) of title 5, United States Code, to develop the
standards described in subparagraph (A), which shall
include--
(I) the proposed scope of the committee;
(II) the interests that may be impacted by the standards;
(III) a list of the proposed membership of the committee;
(IV) the proposed meeting schedule of the committee;
(V) a solicitation for public comment on the committee; and
(VI) the procedures under which an individual may apply for
membership on the committee.
(ii) Comment period.--Notwithstanding section 564(c) of
title 5, United States Code, the Secretary shall provide for
a period, beginning on the date on which the notice is
published under clause (i) and ending on November 30, 2002,
for the submission of public comments on the committee under
this subparagraph.
(iii) Appointment of committee.--Not later than December
30, 2001, the Secretary shall appoint the members of the
negotiated rulemaking committee under this subparagraph.
(iv) Facilitator.--Not later than January 10, 2003, the
negotiated rulemaking committee shall nominate a facilitator
under section 566(c) of title 5, United States Code, to carry
out the activities described in subsection (d) of such
section.
(v) Meetings.--During the period beginning on the date on
which the facilitator is nominated under clause (iv) and
ending on March 30, 2003, the negotiated rulemaking committee
shall meet to develop the standards described in subparagraph
(A).
(D) Preliminary committee report.--
(i) In general.--The negotiated rulemaking committee
appointed under subparagraph (C) shall report to the
Secretary, by not later than March 30, 2003, regarding the
committee's progress on achieving a consensus with regard to
the rulemaking proceedings and whether such consensus is
likely to occur before the target date described in
subsection (F).
(ii) Termination of process and publication of rule by
secretary.--If the committee reports under clause (i) that
the committee has failed to make significant progress towards
such consensus or is unlikely to reach such consensus by the
target date described in subsection (F), the Secretary shall
terminate such process and provide for the publication in the
Federal Register, by not later than June 30, 2003, of a rule
under this paragraph through such other methods as the
Secretary may provide.
(E) Final committee report and publication of rule by
secretary.--
(i) In general.--If the rulemaking committee is not
terminated under subparagraph (D)(ii), the committee shall
submit to the Secretary, by not later than May 30, 2003, a
report containing a proposed rule.
(ii) Publication of rule.--If the Secretary receives a
report under clause (i), the Secretary shall provide for the
publication in the Federal Register, by not later than June
30, 2003, of the proposed rule.
(F) Target date for publication of rule.--As part of the
notice under subparagraph (C)(i), and for purposes of this
paragraph, the ``target date for publication'' (referred to
in section 564(a)(5) of title 5, United States Code) shall be
June 30, 2003.
(G) Effective date.--The provisions of this paragraph shall
apply to group health plans and health insurance issuers that
offer health insurance coverage for plan or coverage years
beginning on or after January 1, 2004.
(3) Payment rate.--In the case of covered items and
services provided by--
(A) a participating provider, the payment rate shall be at
the agreed upon rate, or
(B) a nonparticipating provider, the payment rate shall be
at the rate the plan or issuer would normally pay for
comparable services under subparagraph (A).
(d) Approved Clinical Trial Defined.--
(1) In general.--In this section, the term ``approved
clinical trial'' means a clinical research study or clinical
investigation approved or funded (which may include funding
through in-kind contributions) by one or more of the
following:
(A) The National Institutes of Health.
(B) A cooperative group or center of the National
Institutes of Health.
(C) Either of the following if the conditions described in
paragraph (2) are met:
(i) The Department of Veterans Affairs.
(ii) The Department of Defense.
(2) Conditions for departments.--The conditions described
in this paragraph, for a study or investigation conducted by
a Department, are that the study or investigation has been
reviewed and approved through a system of peer review that
the Secretary determines--
(A) to be comparable to the system of peer review of
studies and investigations used by the National Institutes of
Health, and
(B) assures unbiased review of the highest scientific
standards by qualified individuals who have no interest in
the outcome of the review.
(e) Construction.--Nothing in this section shall be
construed to preclude a plan or issuer from offering coverage
that is broader than the coverage required under this section
with respect to clinical trials.
(f) Plan Satisfaction of Certain Requirements;
Responsibilities of Fiduciaries.--
(1) In general.--For purposes of this section, insofar as a
group health plan provides benefits in the form of health
insurance coverage through a health insurance issuer, the
plan shall be treated as meeting the requirements of this
section with respect to such benefits and not be considered
as failing to meet such requirements because of a failure of
the issuer to meet such requirements so long as the plan
sponsor or its representatives did not cause such failure by
the issuer.
(2) Construction.--Nothing in this section shall be
construed to affect or modify the responsibilities of the
fiduciaries of a group health plan under part 4 of subtitle
B.
(g) Study and Report.--
(1) Study.--The Secretary shall study the impact on group
health plans and health insurance issuers for covering
routine patient care costs for individuals who are entitled
to benefits under this section and who are enrolled in an
approved clinical trial program.
(2) Report to congress.--Not later than January 1, 2006,
the Secretary shall submit a report to Congress that contains
an assessment of--
(A) any incremental cost to group health plans and health
insurance issuers resulting from the provisions of this
section;
(B) a projection of expenditures to such plans and issuers
resulting from this section; and
(C) any impact on premiums resulting from this section.
SEC. 110. REQUIRED COVERAGE FOR MINIMUM HOSPITAL STAY FOR
MASTECTOMIES AND LYMPH NODE DISSECTIONS FOR THE
TREATMENT OF BREAST CANCER AND COVERAGE FOR
SECONDARY CONSULTATIONS.
(a) Inpatient Care.--
(1) In general.--A group health plan, and a health
insurance issuer that offers health insurance coverage, that
provides medical and surgical benefits shall ensure that
inpatient coverage with respect to the treatment of breast
cancer is provided for a period of time as is determined by
the attending physician, in consultation with the patient, to
be medically necessary and appropriate following--
(A) a mastectomy;
(B) a lumpectomy; or
(C) a lymph node dissection for the treatment of breast
cancer.
(2) Exception.--Nothing in this section shall be construed
as requiring the provision of inpatient coverage if the
attending physician and patient determine that a shorter
period of hospital stay is medically appropriate.
(b) Prohibition on Certain Modifications.--In implementing
the requirements of this section, a group health plan, and a
health insurance issuer that offers health insurance
coverage, may not modify the terms and conditions of
coverage based on the determination by a participant,
beneficiary, or enrollee to request less than the minimum
coverage required under subsection (a).
(c) Secondary Consultations.--
(1) In general.--A group health plan, and a health
insurance issuer that offers health insurance coverage, that
provides coverage with respect to medical and surgical
services provided in relation to the diagnosis and treatment
of cancer shall ensure that full coverage is provided for
secondary consultations by specialists in the appropriate
medical fields (including pathology, radiology, and oncology)
to confirm or refute such diagnosis. Such plan or issuer
shall ensure that full coverage is provided for such
secondary consultation whether such consultation is based on
a positive or negative initial diagnosis. In any case in
which the attending physician certifies in writing that
services necessary for such a secondary consultation are not
sufficiently available from specialists operating under the
plan or coverage with respect to whose services coverage is
otherwise provided under such plan or by such issuer, such
plan or issuer shall ensure that coverage is provided with
respect to the services necessary for the secondary
consultation with any other specialist selected by the
attending physician for such purpose at no additional cost to
the individual beyond that which the individual would have
paid if the specialist was participating in the network of
the plan or issuer.
(2) Exception.--Nothing in paragraph (1) shall be construed
as requiring the provision of secondary consultations where
the patient determines not to seek such a consultation.
(d) Prohibition on Penalties or Incentives.--A group health
plan, and a health insurance issuer that offers health
insurance coverage, may not--
(1) penalize or otherwise reduce or limit the reimbursement
of a provider or specialist