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II
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 Representa-
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tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Prescription Digital
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Therapeutics to Support Recovery Act’’.
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SEC. 2. COVERAGE OF PRESCRIPTION DIGITAL THERA-
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PEUTICS UNDER THE MEDICARE PROGRAM.
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(a) COVERAGE AS MEDICAL AND OTHER HEALTH
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SERVICE.—Section 1861(s)(2) of the Social Security Act
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(42 U.S.C. 1395x(s)(2)) is amended—
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(1) in subparagraph (GG), by striking ‘‘and’’ at
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the end;
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(2) in subparagraph (HH), by striking the pe-
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riod at the end and inserting ‘‘; and’’; and
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(3) by adding at the end the following new sub-
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paragraph:
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‘‘(II) prescription digital therapeutics as defined
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in subsection (kkk).’’.
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(b) PRESCRIPTION DIGITAL THERAPEUTICS DE-
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FINED.—Section 1861 of the Social Security Act (42
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U.S.C. 1395x) is amended by adding at the end thereof
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the following new subsection:
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‘‘(kkk) PRESCRIPTION DIGITAL THERAPEUTICS DE-
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FINED.—
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‘‘(1) IN GENERAL.—The term ‘prescription dig-
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ital therapeutic’ means a product, device, internet
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application, or other technology that—
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‘‘(A) is approved or cleared by the Food
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and Drug Administration under a relevant au-
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thority (within the meaning of paragraph (2));
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‘‘(B) has an approved indication for the
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prevention, management, or treatment of a
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mental health or substance use disorder, includ-
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ing opioid use disorder;
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‘‘(C) uses behavioral treatment or modi-
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fication to achieve its intended result; and
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‘‘(D) can only be dispensed pursuant to a
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prescription.
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‘‘(2) RELEVANT
AUTHORITY
DEFINED.—For
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purposes of paragraph (1), the term ‘relevant au-
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thority’ means the following sections of the Federal
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Food, Drug, and Cosmetic Act:
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‘‘(A) Section 510(k) of such Act (21
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U.S.C. 360(k)).
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‘‘(B) Section 515 of such Act (21 U.S.C.
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360e).’’.
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(c) PAYMENT FOR PRESCRIPTION DIGITAL THERA-
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PEUTICS.—Section 1834 of the Social Security Act (42
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U.S.C. 1395m) is amended by adding at the end the fol-
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lowing new subsection:
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‘‘(x) PAYMENT FOR PRESCRIPTION DIGITAL THERA-
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PEUTICS.—
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‘‘(1) SEPARATE PAYMENT.—The Secretary shall
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make a payment (separate from any payment that
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may otherwise be made under this title for a related
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service) in the amount established pursuant to para-
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graph (3) for a prescription digital therapeutic (as
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defined in section 1861(kkk)) that is furnished on or
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after January 1, 2021.
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‘‘(2) PAYMENT
RECIPIENT.—Payment under
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this subsection shall be made to any provider of
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services or supplier enrolled under this title that—
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‘‘(A) prescribes a prescription digital
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therapeutic (as defined in such subsection);
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‘‘(B) uses such prescription digital thera-
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peutic as an integral part of a treatment for a
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related service; and
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‘‘(C) agrees to accept, as payment in full,
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after the application of any deductible or coin-
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surance that may be applied under this part,
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the amount established pursuant to paragraph
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(3).
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‘‘(3) ESTABLISHMENT OF PAYMENT AMOUNT.—
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‘‘(A) IN
GENERAL.—The Secretary shall
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establish a payment methodology for a prescrip-
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tion digital therapeutic only in accordance with
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the requirements of this paragraph.
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‘‘(B) DEVELOPMENT
OF
FEE
SCHED-
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ULE.—Within 180 days of the approval or
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clearance described in section 1861(kkk)(1)(A),
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the Secretary shall develop a proposed fee
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schedule for each prescription digital thera-
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peutic so approved or cleared. In developing
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such fee schedule, the Secretary may use the
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gap filling process described on 84 Federal
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Register 60729 through 60742 and published
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on November 8, 2019.
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‘‘(C) NOTICE AND COMMENT REQUIRED.—
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Upon the development of the proposed fee
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schedule described in subparagraph (B), the
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Secretary shall publish in the Federal Register
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such proposed fee schedule. Section 1871 shall
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apply to any proposed fee scheduled published
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pursuant to this subparagraph.
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‘‘(4) RULE OF CONSTRUCTION.—For purposes
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of paragraph (1), a service is ‘related’ to the use of
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a prescription digital therapeutic if the service—
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‘‘(A) is an integral part of the use of the
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prescription digital therapeutic;
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‘‘(B) is necessary to achieve the full in-
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tended result of the prescription digital thera-
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peutic; and
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‘‘(C) must, pursuant to the approval or
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clearance described in section 1861(kkk)(1)(A),
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be adjunctive to the use of the prescription dig-
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ital therapeutic.’’.
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(d) RULE OF CONSTRUCTION; EFFECTIVE DATE.—
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(1) RULE OF CONSTRUCTION.—No provision of
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this section, or the enactment of this section, shall
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be construed to imply that, in the case of an item
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or service that meets the definition of a prescription
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digital therapeutic under this section for which cov-
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erage or payment under the Medicare program is al-
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ready available prior to the date of the enactment of
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this Act may not be covered or reimbursed under
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such program.
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(2) EFFECTIVE DATE.—The amendments made
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by this section shall apply to a prescription digital
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therapeutic dispensed after December 31, 2020.
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SEC. 3. COVERAGE OF PRESCRIPTION DIGITAL THERA-
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PEUTICS UNDER THE MEDICAID PROGRAM.
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Section 1905(a) of the Social Security Act (42 U.S.C.
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1396d(a)) is amended—
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(1) in paragraph (29), by striking ‘‘; and’’ and
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inserting a semicolon;
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(2) by redesignating paragraph (30) as para-
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graph (31); and
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(3) by inserting the following paragraph after
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paragraph (29):
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‘‘(30) prescription digital therapeutics (as de-
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fined in section 1861(kkk)); and’’.
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Æ
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