Covering Life-saving Investigations Needed in Cancer and Other Life-threatening Conditions through Timely use of Resources for Easy and Affordable Treatment from Medicaid for Enrollees in Need Today Act or the CLINICAL TREATMENT Act
This bill requires state Medicaid programs to cover routine patient costs for items and services that are provided in connection with a qualifying clinical trial regarding cancer or other life-threatening conditions.
The bill defines "routine patient costs" to include items and services that would otherwise be covered under Medicaid absent the patient's participation in the clinical trial; the term includes items and services relating to trial complications, but excludes those items and services that are the subject of the trial or that are provided solely in relation to data analysis.
Additionally, a "qualifying clinical trial" means, among other things, a clinical trial that is approved or funded by specified entities (e.g., the National Institutes of Health) or is an authorized new drug trial.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 913 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 913
To amend title XIX of the Social Security Act to promote access to
life-saving therapies for Medicaid enrollees by ensuring coverage of
routine patient costs for items and services furnished in connection
with participation in qualifying clinical trials, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 30, 2019
Mr. Lujan (for himself and Mr. Bilirakis) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend title XIX of the Social Security Act to promote access to
life-saving therapies for Medicaid enrollees by ensuring coverage of
routine patient costs for items and services furnished in connection
with participation in qualifying clinical trials, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Covering Life-saving Investigations
Needed in Cancer and Other Life-threatening Conditions through Timely
use of Resources for Easy and Affordable Treatment from Medicaid for
Enrollees in Need Today Act'' or the ``CLINICAL TREATMENT Act''.
SEC. 2. PROMOTING ACCESS TO LIFE-SAVING THERAPIES FOR MEDICAID
ENROLLEES BY ENSURING COVERAGE OF ROUTINE PATIENT COSTS
FOR ITEMS AND SERVICES FURNISHED IN CONNECTION WITH
PARTICIPATION IN QUALIFYING CLINICAL TRIALS.
(a) In General.--Section 1905 of the Social Security Act (42 U.S.C.
1396d) is amended--
(1) in subsection (a)--
(A) in paragraph (29), by striking ``and'' at the
end;
(B) by redesignating paragraph (30) as paragraph
(31); and
(C) by inserting after paragraph (29) the following
new paragraph:
``(30) subject to subsection (ff), routine patient costs
for items and services furnished in connection with
participation in a qualifying clinical trial (as defined in
such subsection); and''; and
(2) by adding at the end the following new subsection:
``(ff)(1) Routine Patient Costs.--For purposes of subsection
(a)(30), with respect to a State and an individual enrolled under the
State plan (or a waiver of such plan) who participates in a qualifying
clinical trial, routine patient costs--
``(A) include any item or service provided to the
individual under the qualifying clinical trial, including any
item or service provided to prevent, diagnose, or treat
complications resulting from such participation, to the extent
that the provision of such an item or service to the individual
outside the course of such participation would otherwise be
covered under the State plan (or waiver); and
``(B) does not include--
``(i) the investigational item or service that is
the subject of the qualifying clinical trial; or
``(ii) an item or service that is provided to the
individual solely to satisfy data collection and
analysis needs for the qualifying clinical trial and is
not used in the direct clinical management of the
individual.
``(2) Qualifying Clinical Trial Defined.--
``(A) In general.--For purposes of this subsection and
subsection (a)(30), the term `qualifying clinical trial' means
a phase I, phase II, phase III, or phase IV clinical trial that
is conducted in relation to the prevention, detection, or
treatment of cancer or any other life-threatening condition and
is described in any of the following clauses:
``(i) The study or investigation is approved or
funded (which may include funding through in-kind
contributions) by one or more of the following:
``(I) The National Institutes of Health.
``(II) The Centers for Disease Control and
Prevention.
``(III) The Agency for Healthcare Research
and Quality.
``(IV) The Centers for Medicare & Medicaid
Services.
``(V) A cooperative group or center of any
of the entities described in subclauses (I)
through (IV) or the Department of Defense or
the Department of Veterans Affairs.
``(VI) A qualified non-governmental
research entity identified in the guidelines
issued by the National Institutes of Health for
center support grants.
``(VII) Any of the following if the
conditions described in subparagraph (B) are
met:
``(aa) The Department of Veterans
Affairs.
``(bb) The Department of Defense.
``(cc) The Department of Energy.
``(ii) The clinical trial is conducted under an
investigational new drug application reviewed by the
Food and Drug Administration.
``(iii) The clinical trial is a drug trial that is
exempt from having such an investigational new drug
application.
``(B) Conditions.--For purposes of subparagraph
(A)(i)(VII), the conditions described in this subparagraph,
with respect to a clinical trial approved or funded by an
entity described in such subparagraph (A)(i)(VII), are that the
clinical trial has been reviewed and approved through a system
of peer review that the Secretary determines--
``(i) to be comparable to the system of peer review
of studies and investigations used by the National
Institutes of Health; and
``(ii) assures unbiased review of the highest
scientific standards by qualified individuals with no
interest in the outcome of the review.
``(3) Life-threatening Condition Defined.--For purposes of this
subsection, the term `life-threatening condition' means any disease or
condition from which the likelihood of death is probable unless the
course of the disease or condition is interrupted.
``(4) Coverage Determination Requirements.--A determination with
respect to coverage under subsection (a)(30) for an individual
participating in a qualifying clinical trial--
``(A) shall be expedited and completed within 48 hours;
``(B) shall be made without limitation on the geographic
location or network affiliation of the health care provider
treating such individual or the principal investigator of the
qualifying clinical trial;
``(C) shall be based solely on attestation regarding the
appropriateness of the qualifying clinical trial by the health
care provider and principal investigator described in
subparagraph (B), which shall be made using a streamlined,
uniform form developed for national use by the Secretary and
that includes the option to reference information regarding the
qualifying clinical trial that is publicly available on a
website maintained by the Secretary, such as clinicaltrials.gov
(or a successor website); and
``(D) shall not require submission of the protocols of the
qualifying clinical trial, or any other documentation that may
be proprietary or determined by the Secretary to be burdensome
to provide.''.
(b) Requiring Mandatory Coverage Under State Plan.--Section
1902(a)(10)(A) of such Act is amended, in the matter preceding clause
(i), by striking ``and (29)'' and inserting ``(29), and (30)''.
(c) Ensuring Access for Medicaid Expansion Population.--Section
1937(b)(5) of such Act is amended by inserting before the period at the
end the following: ``, and beginning January 1, 2020, coverage of
routine patient costs for items and services furnished in connection
with participation in a qualifying clinical trial (as defined in
section 1905(ff))''.
(d) Effective Date.--
(1) In general.--The amendments made by this section shall
apply with respect to items and services furnished on or after
the date of the enactment of this Act.
(2) Exception for state legislation.--In the case of a
State plan under title XIX of the Social Security Act (42
U.S.C. 1396 et seq.) that the Secretary of Health and Human
Services determines requires State legislation in order for the
respective plan to meet any requirement imposed by amendments
made by this section, the respective plan shall not be regarded
as failing to comply with the requirements of such title solely
on the basis of its failure to meet such an additional
requirement before the first day of the first calendar quarter
beginning after the close of the first regular session of the
State legislature that begins after the date of the enactment
of this Act. For purposes of the previous sentence, in the case
of a State that has a 2-year legislative session, each year of
the session shall be considered to be a separate regular
session of the State legislature.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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