Congressional Record, Senate — Page S4872, August 4, 2020
Summary
Page S4872 of the Senate section of the Congressional Record for August 4, 2020. SA 2561, submitted by Capito, is printed as intended to be proposed to amendment SA 2499 proposed by McConnell. Amendment text on the page covers coverage of prescription digital therapeutics under the Medicare program, with a proposed fee schedule to be developed within 180 days of approval or clearance and a notice and comment requirement. Other text requires a State process to address refusal to return to work, provides for the Secretary of the Treasury to recover amounts provided to certain entities, and adds a section on access to non-opioid treatments for pain.
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“Congressional Record, Senate — Page S4872, August 4, 2020.”
Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/crec-crec-2020-08-04-crec-2020-08-04-pt1-pgs4872-a8da6d7b65/
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S4872 CONGRESSIONAL RECORD — SENATE August 4, 2020
(d) REQUIREMENT FOR RETURN TO WORK NO- SA 2561. Mrs. CAPITO submitted an part, the amount established pursuant to
TIFICATION AND REPORTING.—Section 2104(b) amendment intended to be proposed to paragraph (3).
of the Relief for Workers Affected by amendment SA 2499 proposed by Mr. ‘‘(3) ESTABLISHMENT OF PAYMENT AMOUNT.—
Coronavirus Act (contained in subtitle A of ‘‘(A) IN GENERAL.—The Secretary shall es-
MCCONNELL to the bill S. 178, to con-
title II of division A of the CARES Act (Pub- tablish a payment methodology for a pre-
lic Law 116–136)) is amended by adding at the demn gross human rights violations of scription digital therapeutic only in accord-
end the following new paragraph: ethnic Turkic Muslims in Xinjiang, and ance with the requirements of this para-
‘‘(3) Beginning 30 days after the date of en- calling for an end to arbitrary deten- graph.
actment of this paragraph, any agreement tion, torture, and harassment of these ‘‘(B) DEVELOPMENT OF FEE SCHEDULE.—
under this section shall require that the communities inside and outside China; Within 180 days of the approval or clearance
State has in place a process to address re- which was ordered to lie on the table; described in section 1861(kkk)(1)(A), the Sec-
fusal to return to work or refusal of suitable as follows: retary shall develop a proposed fee schedule
work that includes the following: for each prescription digital therapeutic so
At the appropriate place, insert the fol-
‘‘(A) Providing a plain-language notice to approved or cleared. In developing such fee
lowing:
individuals at the time of applying for bene- schedule, the Secretary may use the gap fill-
SEC. ll. COVERAGE OF PRESCRIPTION DIGITAL
fits regarding State law provisions relating ing process described on 84 Federal Register
THERAPEUTICS UNDER THE MEDI-
to each of the following: CARE PROGRAM. 60729 through 60742 and published on Novem-
‘‘(i) Return to work requirements. ber 8, 2019.
(a) COVERAGE AS MEDICAL AND OTHER
‘‘(ii) Rights to refuse to return to work or ‘‘(C) NOTICE AND COMMENT REQUIRED.—Upon
HEALTH SERVICE.—Section 1861(s)(2) of the
to refuse suitable work. the development of the proposed fee schedule
Social Security Act (42 U.S.C. 1395x(s)(2)) is
‘‘(iii) How to contest the denial of a claim described in subparagraph (B), the Secretary
amended—
that has been denied due to a claim by an shall publish in the Federal Register such
(1) in subparagraph (GG), by striking
employer that the individual refused to re- proposed fee schedule. Section 1871 shall
‘‘and’’ at the end;
turn to work or refused suitable work. apply to any proposed fee scheduled pub-
(2) in subparagraph (HH), by striking the
‘‘(B) Providing a plain-language notice to lished pursuant to this subparagraph.
period at the end and inserting ‘‘; and’’; and
employers through any system used by em- ‘‘(4) RULE OF CONSTRUCTION.—For purposes
(3) by adding at the end the following new
ployers or any regular correspondence sent of paragraph (1), a service is ‘related’ to the
subparagraph:
to employers regarding how to notify the use of a prescription digital therapeutic if
‘‘(II) prescription digital therapeutics as
State if an individual refuses to return to the service—
defined in subsection (kkk);’’.
work. (b) PRESCRIPTION DIGITAL THERAPEUTICS ‘‘(A) is an integral part of the use of the
‘‘(C) Other items determined appropriate DEFINED.—Section 1861 of the Social Secu- prescription digital therapeutic;
by the Secretary of Labor.’’. rity Act (42 U.S.C. 1395x) is amended by add- ‘‘(B) is necessary to achieve the full in-
(e) EFFECTIVE DATE.—The amendments ing at the end thereof the following new sub- tended result of the prescription digital
made by this section (other than the amend- section: therapeutic; and
ment made by subsection (d)) shall take ef- ‘‘(kkk) PRESCRIPTION DIGITAL THERA- ‘‘(C) must, pursuant to the approval or
fect as if included in the enactment of the PEUTICS DEFINED.— clearance described in section
Relief for Workers Affected by Coronavirus ‘‘(1) IN GENERAL.—The term ‘prescription 1861(kkk)(1)(A), be adjunctive to the use of
Act (contained in subtitle A of title II of di- digital therapeutic’ means a product, device, the prescription digital therapeutic.’’.
vision A of the CARES Act (Public Law 116– internet application, or other technology (d) RULE OF CONSTRUCTION; EFFECTIVE
136)). that— DATE.—
SEC. 3. EMERGENCY DESIGNATION. ‘‘(A) is approved or cleared by the Food (1) RULE OF CONSTRUCTION.—No provision of
(a) IN GENERAL.—The amounts provided by and Drug Administration under a relevant this section, or the enactment of this sec-
this Act and the amendments made by this authority (within the meaning of paragraph tion, shall be construed to imply that, in the
Act are designated as an emergency require- (2)); case of an item or service that meets the def-
ment pursuant to section 4(g) of the Statu- ‘‘(B) has an approved indication for the inition of a prescription digital therapeutic
tory Pay-As-You-Go Act of 2010 (2 U.S.C. prevention, management, or treatment of a under this section for which coverage or pay-
933(g)). mental health or substance use disorder, in- ment under the Medicare program is already
(b) DESIGNATION IN SENATE.—In the Senate, cluding opioid use disorder; available prior to the date of the enactment
this Act and the amendments made by this ‘‘(C) uses behavioral treatment or modi- of this Act may not be covered or reimbursed
Act are designated as an emergency require- fication to achieve its intended result; and under such program.
ment pursuant to section 4112(a) of H. Con. ‘‘(D) can only be dispensed pursuant to a (2) EFFECTIVE DATE.—The amendments
Res. 71 (115th Congress), the concurrent reso- prescription. made by this section shall apply to a pre-
lution on the budget for fiscal year 2018. ‘‘(2) RELEVANT AUTHORITY DEFINED.—For scription digital therapeutic dispensed after
purposes of paragraph (1), the term ‘relevant December 31, 2020.
SEC. ll. COVERAGE OF PRESCRIPTION DIGITAL
SA 2560. Mr. COTTON submitted an authority’ means the following sections of
THERAPEUTICS UNDER THE MED-
amendment intended to be proposed to the Federal Food, Drug, and Cosmetic Act: ICAID PROGRAM.
amendment SA 2499 proposed by Mr. ‘‘(A) Section 510(k) of such Act (21 U.S.C.
Section 1905(a) of the Social Security Act
360(k)).
MCCONNELL to the bill S. 178, to con- (42 U.S.C. 1396d(a)) is amended—
‘‘(B) Section 515 of such Act (21 U.S.C.
demn gross human rights violations of (1) in paragraph (29), by striking ‘‘; and’’
360e).’’.
ethnic Turkic Muslims in Xinjiang, and and inserting a semicolon;
(c) PAYMENT FOR PRESCRIPTION DIGITAL
calling for an end to arbitrary deten- (2) by redesignating paragraph (30) as para-
THERAPEUTICS.—Section 1834 of the Social
graph (31); and
tion, torture, and harassment of these Security Act (42 U.S.C. 1395m) is amended by
(3) by inserting the following paragraph
communities inside and outside China; adding at the end the following new sub-
after paragraph (29):
which was ordered to lie on the table; section:
‘‘(x) PAYMENT FOR PRESCRIPTION DIGITAL ‘‘(30) prescription digital therapeutics (as
as follows: defined in section 1861(kkk)); and’’.
THERAPEUTICS.—
At the end of the amendment, add the fol- ‘‘(1) SEPARATE PAYMENT.—The Secretary
lowing: shall make a payment (separate from any
SA 2562. Mrs. CAPITO submitted an
SEC. 3. FUNDING LIMITATIONS. payment that may otherwise be made under amendment intended to be proposed to
(a) PROHIBITION.—None of the funds appro- this title for a related service) in the amount amendment SA 2499 proposed by Mr.
priated under this Act or under the CARES established pursuant to paragraph (3) for a MCCONNELL to the bill S. 178, to con-
Act (Public Law 116–136), as amended by this prescription digital therapeutic (as defined demn gross human rights violations of
Act, may be provided to an entity that is in section 1861(kkk)) that is furnished on or ethnic Turkic Muslims in Xinjiang, and
under the foreign ownership, control, or in- after January 1, 2021. calling for an end to arbitrary deten-
fluence of— ‘‘(2) PAYMENT RECIPIENT.—Payment under tion, torture, and harassment of these
(1) the Government of the People’s Repub- this subsection shall be made to any provider
lic of China; of services or supplier enrolled under this
communities inside and outside China;
(2) the Chinese Communist Party; or title that— which was ordered to lie on the table;
SSpencer on DSK126QN23PROD with SENATE
(3) an entity domiciled in the People’s Re- ‘‘(A) prescribes a prescription digital as follows:
public of China. therapeutic (as defined in such subsection); At the appropriate place, insert the fol-
(b) CLAWBACK.—The Secretary of the ‘‘(B) uses such prescription digital thera- lowing:
Treasury, in consultation with the Secretary peutic as an integral part of a treatment for SEC. ll. ACCESS TO NON-OPIOID TREATMENTS
of State, shall recover all of the amounts ap- a related service; and FOR PAIN.
propriated under this Act or under the ‘‘(C) agrees to accept, as payment in full, (a) IN GENERAL.—Section 1833(t) of the So-
CARES Act that were provided to entities after the application of any deductible or co- cial Security Act (42 U.S.C. 1395l(t)) is
described in subsection (a). insurance that may be applied under this amended—
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