[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3532 Introduced in Senate (IS)]
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116th CONGRESS
2d Session
S. 3532
To amend titles XVIII and XIX of the Social Security Act to provide
coverage of prescription digital therapeutics for the treatment of
mental health and substance use disorders under the Medicare and
Medicaid programs, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 18, 2020
Mrs. Capito (for herself and Mrs. Shaheen) introduced the following
bill; which was read twice and referred to the Committee on Finance
_______________________________________________________________________
A BILL
To amend titles XVIII and XIX of the Social Security Act to provide
coverage of prescription digital therapeutics for the treatment of
mental health and substance use disorders under the Medicare and
Medicaid programs, 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 ``Prescription Digital Therapeutics to
Support Recovery Act''.
SEC. 2. COVERAGE OF PRESCRIPTION DIGITAL THERAPEUTICS UNDER THE
MEDICARE PROGRAM.
(a) Coverage as Medical and Other Health Service.--Section
1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)) is
amended--
(1) in subparagraph (GG), by striking ``and'' at the end;
(2) in subparagraph (HH), by striking the period at the end
and inserting ``; and''; and
(3) by adding at the end the following new subparagraph:
``(II) prescription digital therapeutics as defined in
subsection (kkk).''.
(b) Prescription Digital Therapeutics Defined.--Section 1861 of the
Social Security Act (42 U.S.C. 1395x) is amended by adding at the end
thereof the following new subsection:
``(kkk) Prescription Digital Therapeutics Defined.--
``(1) In general.--The term `prescription digital
therapeutic' means a product, device, internet application, or
other technology that--
``(A) is approved or cleared by the Food and Drug
Administration under a relevant authority (within the
meaning of paragraph (2));
``(B) has an approved indication for the
prevention, management, or treatment of a mental health
or substance use disorder, including opioid use
disorder;
``(C) uses behavioral treatment or modification to
achieve its intended result; and
``(D) can only be dispensed pursuant to a
prescription.
``(2) Relevant authority defined.--For purposes of
paragraph (1), the term `relevant authority' means the
following sections of the Federal Food, Drug, and Cosmetic Act:
``(A) Section 510(k) of such Act (21 U.S.C.
360(k)).
``(B) Section 515 of such Act (21 U.S.C. 360e).''.
(c) Payment for Prescription Digital Therapeutics.--Section 1834 of
the Social Security Act (42 U.S.C. 1395m) is amended by adding at the
end the following new subsection:
``(x) Payment for Prescription Digital Therapeutics.--
``(1) Separate payment.--The Secretary shall make a payment
(separate from any payment that may otherwise be made under
this title for a related service) in the amount established
pursuant to paragraph (3) for a prescription digital
therapeutic (as defined in section 1861(kkk)) that is furnished
on or after January 1, 2021.
``(2) Payment recipient.--Payment under this subsection
shall be made to any provider of services or supplier enrolled
under this title that--
``(A) prescribes a prescription digital therapeutic
(as defined in such subsection);
``(B) uses such prescription digital therapeutic as
an integral part of a treatment for a related service;
and
``(C) agrees to accept, as payment in full, after
the application of any deductible or coinsurance that
may be applied under this part, the amount established
pursuant to paragraph (3).
``(3) Establishment of payment amount.--
``(A) In general.--The Secretary shall establish a
payment methodology for a prescription digital
therapeutic only in accordance with the requirements of
this paragraph.
``(B) Development of fee schedule.--Within 180 days
of the approval or clearance described in section
1861(kkk)(1)(A), the Secretary shall develop a proposed
fee schedule for each prescription digital therapeutic
so approved or cleared. In developing such fee
schedule, the Secretary may use the gap filling process
described on 84 Federal Register 60729 through 60742
and published on November 8, 2019.
``(C) Notice and comment required.--Upon the
development of the proposed fee schedule described in
subparagraph (B), the Secretary shall publish in the
Federal Register such proposed fee schedule. Section
1871 shall apply to any proposed fee scheduled
published pursuant to this subparagraph.
``(4) Rule of construction.--For purposes of paragraph (1),
a service is `related' to the use of a prescription digital
therapeutic if the service--
``(A) is an integral part of the use of the
prescription digital therapeutic;
``(B) is necessary to achieve the full intended
result of the prescription digital therapeutic; and
``(C) must, pursuant to the approval or clearance
described in section 1861(kkk)(1)(A), be adjunctive to
the use of the prescription digital therapeutic.''.
(d) Rule of Construction; Effective Date.--
(1) Rule of construction.--No provision of this section, or
the enactment of this section, shall be construed to imply
that, in the case of an item or service that meets the
definition of a prescription digital therapeutic under this
section for which coverage or payment under the Medicare
program is already available prior to the date of the enactment
of this Act may not be covered or reimbursed under such
program.
(2) Effective date.--The amendments made by this section
shall apply to a prescription digital therapeutic dispensed
after December 31, 2020.
SEC. 3. COVERAGE OF PRESCRIPTION DIGITAL THERAPEUTICS UNDER THE
MEDICAID PROGRAM.
Section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)) is
amended--
(1) in paragraph (29), by striking ``; and'' and inserting
a semicolon;
(2) by redesignating paragraph (30) as paragraph (31); and
(3) by inserting the following paragraph after paragraph
(29):
``(30) prescription digital therapeutics (as defined in
section 1861(kkk)); and''.
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