S.Amdt. 2561

SA 2561. Mrs. CAPITO submitted an amendment intended to be proposed
to amendment SA 2499 proposed by Mr. McConnell to the bill S. 178, to
condemn gross human rights violations of ethnic Turkic Muslims in
Xinjiang, and calling for an end to arbitrary detention, torture, and
harassment of these communities inside and outside China; which was
ordered to lie on the table; as follows:

At the appropriate place, insert the following:

SEC. __. 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. __. 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''.
______