[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8816 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 8816
To amend title XVIII of the Social Security Act to provide for a
cognitive impairment detection benefit under the Medicare program, and
for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 25, 2024
Mr. Buchanan introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committee on
Ways and Means, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to provide for a
cognitive impairment detection benefit under the Medicare program, 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 ``American Medical Innovation and
Investment Act of 2024''.
SEC. 2. COGNITIVE IMPAIRMENT DETECTION BENEFIT IN THE MEDICARE ANNUAL
WELLNESS VISIT AND INITIAL PREVENTIVE PHYSICAL
EXAMINATION.
(a) Annual Wellness Visit.--
(1) In general.--Section 1861(hhh)(2) of the Social
Security Act (42 U.S.C. 1395x(hhh)(2)) is amended by striking
subparagraph (D) and inserting the following:
``(D) Detection of any cognitive impairment that
shall--
``(i) be performed using one of the
cognitive impairment detection tools identified
by the National Institute on Aging as meeting
its criteria for selecting instruments to
detect cognitive impairment in the primary care
setting; and
``(ii) include documentation of the tool
used for detecting cognitive impairment and
results of the assessment in the patient's
medical record.''.
(2) Effective date.--The amendment made by paragraph (1)
shall apply to annual wellness visits furnished on or after
January 1, 2025.
(b) Initial Preventive Physical Examination.--
(1) In general.--Section 1861(ww)(1) of the Social Security
Act (42 U.S.C. 1395x(ww)(1)) is amended by striking ``agreement
with the individual, and'' and inserting ``agreement with the
individual, detection of any cognitive impairment as described
in subsection (hhh)(2)(D), and''.
(2) Effective date.--The amendment made by paragraph (1)
shall apply to initial preventive physical examinations
furnished on or after January 1, 2025.
SEC. 3. IMPROVING THE NATIONAL AND LOCAL COVERAGE DETERMINATION
PROCESSES UNDER THE MEDICARE PROGRAM.
(a) In General.--Section 1862(l) of the Social Security Act (42
U.S.C. 1395y(l)) is amended by adding at the end the following new
paragraph:
``(7) Limitation on duration of coverage with evidence
development determinations.--
``(A) In general.--Subject to subparagraph (B), in
the case of a final decision under paragraph (3)(C)(i)
(including any such decision made on a class-wide
basis) made on or after the date of the enactment of
this paragraph that results in coverage of an item or
service pursuant to subsection (a)(1)(E), the Secretary
shall, not later than 10 years after the date on which
such coverage becomes effective pursuant to such
subsection, initiate a redetermination with respect to
such item or service.
``(B) Exception.--The Secretary may delay a
redetermination described in subparagraph (A) with
respect to an item or service for a period of time
determined appropriate by the Secretary if--
``(i) the Secretary finds that such item or
service is reasonable and necessary to carry
out the purposes described in section 1142; or
``(ii) the entity responsible for such item
or service requests such extension.
``(C) Posting of information.--Not later than 1
year after the date of the enactment of this paragraph,
and annually thereafter, the Secretary post on the
public website of the Centers for Medicare & Medicaid
Services the following information:
``(i) The number of items and services
covered under this title pursuant to subsection
(a)(1)(E).
``(ii) A description of each such item or
service.
``(iii) The year in which coverage of each
such item or service became effective pursuant
to such subsection.''.
(b) Provision of Explanation in Case of Certain Rejected
Requests.--Section 1862(l) of the Social Security Act (42 U.S.C.
1395y(l)), as amended by subsection (a), is further amended by adding
at the end the following new paragraph:
``(8) Requirement to provide explanation in case of certain
rejected requests.--With respect to each document received by
the Secretary on or after the date that is 1 year after the
date of the enactment of this paragraph that identifies itself
as a complete, formal request for a national coverage
determination (as described in the notice entitled `Medicare
Program; Revised Process for Making National Coverage
Determinations' (78 Fed. Reg. 48164) or a successor
regulation), the Secretary shall, not later than 90 days after
receipt of such document--
``(A) determine whether such document is a
complete, formal request for a national coverage
determination; and
``(B) in the case that the Secretary finds that
such document is not a complete, formal request for a
national coverage determination, transmit to the entity
submitting such document information on such finding
that includes a specification of additional information
needed to make such document a complete, formal request
for a national coverage determination.''.
(c) Improving Access to Items and Services Under Local Coverage
Determinations.--Section 1862(l)(5) of the Social Security Act (42
U.S.C. 1395y(l)(5)) is amended by adding at the end the following new
subparagraph:
``(E) Ensuring consistency with applicable rules.--
The Secretary shall require each Medicare
administrative contractor that develops a local
coverage determination to ensure that any such local
coverage determination does not conflict with any law,
ruling, regulation, national coverage determination,
payment policy, or coding policy.''.
(d) Funding.--There are authorized to be appropriated $1,000,000
for fiscal year 2024 for purposes of carrying out the amendments made
by this section.
SEC. 4. MEDICARE COVERAGE OF EXTERNAL INFUSION PUMPS AND NON-SELF-
ADMINISTRABLE HOME INFUSION DRUGS.
Section 1861(n) of the Social Security Act (42 U.S.C. 1395x(n)) is
amended by adding at the end the following new sentence: ``Beginning
with the first calendar quarter beginning on or after the date that is
1 year after the date of the enactment of this sentence, an external
infusion pump and associated home infusion drug (as defined in
subsection (iii)(3)(C)) or other associated supplies that do not meet
the appropriate for use in the home requirement applied to the
definition of durable medical equipment under section 414.202 of title
42, Code of Federal Regulations (or any successor to such regulation)
shall be treated as meeting such requirement if each of the following
criteria is satisfied:
``(1) The prescribing information approved by the Food and
Drug Administration for the home infusion drug associated with
the pump instructs that the drug should be administered by or
under the supervision of a health care professional.
``(2) A qualified home infusion therapy supplier (as
defined in subsection (iii)(3)(D)) administers or supervises
the administration of the drug or biological in a safe and
effective manner in the patient's home (as defined in
subsection (iii)(3)(B)).
``(3) The prescribing information described in paragraph
(1) instructs that the drug should be infused at least 12 times
per year--
``(A) intravenously or subcutaneously; or
``(B) at infusion rates that the Secretary
determines would require the use of an external
infusion pump.''.
SEC. 5. GUIDANCE ON MEDICARE PAYMENT FOR CERTAIN ITEMS INVOLVING
ARTIFICIAL INTELLIGENCE.
Not later than January 1, 2026, the Secretary of Health and Human
Services shall use existing communications mechanisms to issue guidance
on requirements for payment under part B of title XVIII of the Social
Security Act (42 U.S.C. 1395j et seq.) for remote monitoring devices,
such as continuous glucose monitors, that--
(1) use an artificial intelligence component (such as a
continuous adjustment component); and
(2) transmit information to a health care provider for
purposes of management and treatment of an individual.
SEC. 6. CLARIFYING PAYMENT FOR PRESCRIPTION DIGITAL THERAPEUTICS UNDER
MEDICARE.
(a) Guidance to Physicians.--Not later than January 1, 2026, the
Secretary of Health and Human Services (in this section referred to as
the ``Secretary'') shall use existing communication mechanisms to issue
guidance on requirements for payment under part B of title XVIII of the
Social Security Act (42 U.S.C. 1395j et seq.) for a prescription
digital therapeutic furnished by a physician or incident to a
physician's professional service.
(b) Guidance to MA Organizations.--Not later than 1 year after the
date of the enactment of this Act, the Secretary shall issue to MA
organizations guidance to clarify the requirements relating to when
such organizations may provide a prescription digital therapeutic as a
supplemental benefit to an individual enrolled under a MA plan.
(c) Report to Congress.--Not later than January 1, 2026, the
Secretary shall submit to the Committee on Ways and Means and the
Committee on Energy and Commerce of the House of Representatives, and
the Finance Committee of the Senate, a report that includes--
(1) an analysis of any existing statutory authority for the
Secretary to provide payment for prescription digital
therapeutics under the Medicare program; and
(2) a description of any additional statutory authority
that is needed by the Secretary to expand such coverage.
(d) Definitions.--In this section:
(1) MA terms.--The terms ``MA plan'', ``MA organization'',
and ``supplemental benefit'' have the meanings given each such
term in part C of title XVIII of the Social Security Act (42
U.S.C. 1395w-21 et seq.).
(2) Medicare program.--The term ``Medicare program'' means
the Medicare program under title XVIII of the Social Security
Act (42 U.S.C. 1395 et seq.).
(3) Physician.--The term ``physician'' has the meaning
given such term in section 1861(r) of the Social Security Act
(42 U.S.C. 1395x(r)).
(4) Prescription digital therapeutic.--The term
``prescription digital therapeutic'' means an evidence-based
software product, including any such product that is a
combination product described in section 503(g) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), intended for
use in the management, prevention, or treatment of a disease or
condition, that acts directly as a medical intervention or
guides the delivery of a medical intervention and that--
(A) is regulated by the Food and Drug
Administration as a device (as defined in section 201
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321)), including any such device regulated as a
combination product (as described in section 503(g) of
such Act (21 U.S.C. 353(g));
(B) is cleared under section 510(k), classified
under section 513(f)(2), or approved under section 515
of such Act (21 U.S.C. 360(k), 360c(f)(2), 360e); and
(C) may not be furnished to an individual without a
prescription from a physician.
<all>