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H.R.4577
Departments of Labor, Health and Human Services, and Education, and
Related Agencies Appropriations Act, 2001 (Public Print)
`SEC. 726. CONTINUITY OF CARE.
`(a) TERMINATION OF PROVIDER- If a contract between a group health
plan (other than a fully insured group health plan) 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, and an individual who is
a participant or beneficiary in the plan 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 receives or
provides notice of such termination, the plan 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
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 to
non-elective surgery that has been scheduled before the date of the notice
of the termination of the provider under subsection (a)(1).
`(A) a participant or beneficiary 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 or beneficiary 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 (other than
a fully insured group health plan) 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 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 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 this section had not been terminated.
`(2) The treating health care 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.
`(3) The treating health care 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.
`(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 from requiring that the health care
provider--
`(A) notify participants or beneficiaries of their rights under this section;
or
`(B) provide the plan with the name of each participant or
beneficiary who the provider believes is eligible for transitional care
under this section.
`(e) DEFINITIONS- In this section:
`(1) CONTRACT- The term `contract between a plan and a treating
health care provider' shall include a contract between such a plan 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 or beneficiary under the
plan, 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
`(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, but does not include a termination of the
contract by the plan for failure to meet applicable quality standards or for
fraud.
`(f) RIGHT TO EXTERNAL REVIEW- Pursuant to the requirements of section
503B, a participant or beneficiary shall have the right to an independent
external review if the denial of an item or service or condition that is
required to be covered under this section is eligible for such review.
`SEC. 727. PROTECTION OF PATIENT-PROVIDER COMMUNICATIONS.
`(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.
`(b) RULE OF CONSTRUCTION- Nothing in this section shall be construed
as requiring a group health plan (other than a fully insured group health
plan) to provide specific benefits under the terms of such plan.
`SEC. 728. PATIENT'S RIGHT TO PRESCRIPTION DRUGS.
`(a) IN GENERAL- To the extent that a group health plan (other than a
fully insured group health plan) provides coverage for benefits with respect
to prescription drugs, and limits such coverage to drugs included in a
formulary, the plan shall--
`(1) ensure the participation of physicians and pharmacists in
developing and reviewing such formulary; and
`(2) in accordance with the applicable quality assurance and
utilization review standards of the plan, provide for exceptions from the
formulary limitation when a non-formulary alternative is medically necessary
and appropriate.
`(b) RIGHT TO EXTERNAL REVIEW- Pursuant to the requirements of section
503B, a participant or beneficiary shall have the right to an independent
external review if the denial of an item or service or condition that is
required to be covered under this section is eligible for such review.
`SEC. 729. SELF-PAYMENT FOR BEHAVIORAL HEALTH CARE SERVICES.
`(a) IN GENERAL- A group health plan (other than a fully insured group
health plan) may not--
`(1) prohibit or otherwise discourage a participant or beneficiary
from self-paying for behavioral health care services once the plan has
denied coverage for such services; or
`(2) terminate a health care provider because such provider permits
participants or beneficiaries to self-pay for behavioral health care
services--
`(A) that are not otherwise covered under the plan;
or
`(B) for which the group health plan provides limited coverage, to
the extent that the group health plan denies coverage of the
services.
`(b) RULE OF CONSTRUCTION- Nothing in subsection (a)(2)(B) shall be
construed as prohibiting a group health plan from terminating a contract with
a health care provider for failure to meet applicable quality standards or for
fraud.
`SEC. 730. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CANCER
CLINICAL TRIALS.
`(1) IN GENERAL- If a group health plan (other than a fully insured
group health plan) provides coverage to a qualified individual (as defined
in subsection (b)), the plan--
`(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 or beneficiaries 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 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 and who meets the following
conditions:
`(1)(A) The individual has been diagnosed with cancer for which no
standard treatment is effective.
`(B) The individual is eligible to participate in an approved
clinical trial according to the trial 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.
`(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 or beneficiary provides medical and
scientific information establishing that the individual's participation in
such trial would be appropriate based upon the individual meeting the
conditions described in paragraph (1).
`(1) IN GENERAL- Under this section a group health plan (other than
a fully insured group health plan) shall provide for payment for routine
patient costs described in subsection (a)(2) but is not required to pay for
costs of items and services that are 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 clinical trials that group health
plans 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, 2000,
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, 2000, for the submission of public comments on the
committee under this subparagraph.
`(iii) APPOINTMENT OF COMMITTEE- Not later than December 30,
2000, the Secretary shall appoint the members of the negotiated
rulemaking committee under this subparagraph.
`(iv) FACILITATOR- Not later than January 10, 2001, 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,
2001, 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, 2001, 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,
2001, of a rule under this paragraph through such other methods as the
Secretary may provide.
`(E) FINAL COMMITTEE REPORT AND PUBLICATION OR 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, 2001, a report containing a proposed
rule.
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