[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8816 Introduced in House (IH)]

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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.
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