[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 723 Introduced in Senate (IS)]
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118th CONGRESS
1st Session
S. 723
To amend titles XVIII and XIX of the Social Security Act to provide for
coverage of prescription digital therapeutics under such titles, and
for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 8, 2023
Mrs. Shaheen (for herself, Mrs. Capito, Mr. Booker, and Mrs. Blackburn)
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 for
coverage of prescription digital therapeutics under such titles, 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 ``Access to Prescription Digital
Therapeutics Act of 2023''.
SEC. 2. COVERAGE AND PAYMENT OF PRESCRIPTION DIGITAL THERAPEUTICS UNDER
THE MEDICARE PROGRAM.
(a) Prescription Digital Therapeutic Defined.--Section 1861 of the
Social Security Act (42 U.S.C. 1395x) is amended by adding at the end
the following new subsection:
``(nnn) Prescription Digital Therapeutic.--The term `prescription
digital therapeutic' means a product, device, internet application, or
other technology that--
``(1) is cleared or approved under section 510(k),
513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act;
``(2) has a cleared or approved indication for the
prevention, management, or treatment of a medical disease,
condition, or disorder;
``(3) primarily uses software to achieve its intended
result; and
``(4) is a device that is exempt from section 502(f)(1) of
the Federal Food, Drug, and Cosmetic Act under section 801.109
of title 21 of the Code of Federal Regulations (or any
successor regulation).''.
(b) 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 (II), by striking ``and'' at the end;
(2) in subparagraph (JJ), by adding ``and'' at the end; and
(3) by adding at the end the following new subparagraph:
``(KK) prescription digital therapeutics furnished on or
after January 1, 2024;''.
(c) Requirements for Prescription Digital Therapeutics Under
Medicare.--Part B of the Social Security Act (42 U.S.C. 1395j et seq.)
is amended by inserting after section 1834A the following new section:
``SEC. 1834B. REQUIREMENTS FOR PRESCRIPTION DIGITAL THERAPEUTICS.
``(a) Payment.--
``(1) In general.--Not later than 1 year after the date of
enactment of this section, the Secretary shall establish a
payment methodology for manufacturers of prescription digital
therapeutics, which may consist of a one-time payment or
periodic payments, as determined appropriate by the Secretary.
``(2) Considerations for payment methodology.--For purposes
of establishing the payment methodology under paragraph (1),
the Secretary shall consider--
``(A) the actual list charge of such prescription
digital therapeutic;
``(B) the weighted median (calculated by arraying
the distribution of all payment rates reported for the
most recent period for which such rates were reported
under subsection (c)(1) for each prescription digital
therapeutic weighted by volume for each payor and each
manufacturer) for such prescription digital
therapeutic;
``(C) in the case of a prescription digital
therapeutic that requires ongoing use, the amount for
such ongoing use; and
``(D) other factors as determined by the Secretary.
``(b) Coding.--
``(1) In general.--Not later than 2 years after the date of
enactment of this section, the Secretary shall establish
product-specific HCPCS codes for prescription digital
therapeutic covered under this title.
``(2) Temporary code.--The Secretary shall adopt temporary
product-specific HCPCS codes for purposes of providing payment
under this title until a permanent product-specific HCPCS code
has been established under paragraph (1).
``(c) Manufacturer Reporting.--
``(1) In general.--Beginning on January 1, 2024, each
manufacturer of a prescription digital therapeutic covered
under this title shall submit to the Secretary, at such time
and in such manner as specified by the Secretary, and annually
thereafter, a report describing--
``(A) the payment rate that was paid by each
private payor for each prescription digital therapeutic
during the period specified by the Secretary;
``(B) the volume of such prescription digital
therapeutic distributed to each such payor for such
period; and
``(C) the number of individual users of such
prescription digital therapeutic for such period.
``(2) Treatment of discounts.--The payment rate reported by
a manufacturer in accordance with paragraph (1)(A) shall
reflect all discounts, rebates, coupons, and other price
concessions, including those described in section 1847A(c)(3).
``(3) Civil monetary penalty.--
``(A) In general.--If the Secretary determines that
a manufacturer has failed to report, or made a
misrepresentation or omission in reporting, information
under this subsection with respect to a prescription
digital therapeutic, the Secretary may apply a civil
money penalty in an amount of up to $10,000 per day for
each failure to report or each such misrepresentation
or omission.
``(B) Application.--The provisions of section 1128A
(other than subsections (a) and (b)) shall apply to a
civil money penalty under this paragraph in the same
manner as they apply to a civil money penalty or
proceeding under section 1128A(a).
``(4) Confidentiality.--Information reported under this
subsection shall be treated in the same manner in which
information disclosed by a manufacturer or a wholesaler of a
covered outpatient drug is treated under section 1927(b)(3)(D).
``(d) Definitions.--For purposes of this section:
``(1) Actual list charge.--The term `actual list charge'
means the publicly available payment rate for a prescription
digital therapeutic on the first day that such prescription
digital therapeutic is available for purchase by a private
payor.
``(2) HCPCS.--The term `HCPCS' means, with respect to an
item, the code under the Healthcare Common Procedure Coding
System (HCPCS) (or a successor code) for such item.
``(3) Manufacturer.--The term `manufacturer' has the
meaning given such term by section 820.3(o) of title 21, Code
of Federal Regulations (or any successor regulation).
``(4) Prescription digital therapeutic.--The term
`prescription digital therapeutic' has the meaning given such
term in section 1861(nnn).
``(5) Private payor.--The term `private payor' has the
meaning given such term in section 1834A(a)(8).''.
SEC. 3. COVERAGE OF PRESCRIPTION DIGITAL THERAPEUTICS UNDER THE
MEDICAID PROGRAM.
(a) In General.--Section 1905(a) of the Social Security Act (42
U.S.C. 1396d(a)) is amended--
(1) in paragraph (30), by striking ``; and'' and inserting
a semicolon;
(2) by redesignating paragraph (31) as paragraph (32); and
(3) by inserting the following paragraph after paragraph
(30):
``(31) prescription digital therapeutics (as defined in
section 1861(nnn)); and''.
(b) Conforming Amendments.--Effective the day after the amendments
made by sections 5121 and 5122 of division FF of the Consolidated
Appropriations Act, 2023 (Public Law 117-328) take effect--
(1) subsections (a)(84)(A) and (nn)(3) of section 1902 of
the Social Security Act (42 U.S.C. 1396a) are each amended by
striking ``paragraph (31)'' and inserting ``the last numbered
paragraph''; and
(2) the fifth sentence of section 1905(a) of such Act (42
U.S.C. 1396d(a)) is amended by striking ``paragraph (30)'' and
inserting ``the last numbered paragraph''.
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