Section 1 Short title
This Act may be cited as the “American Medical Innovation and Investment Act of 2024”.
American Medical Innovation and Investment Act of 2024
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.
Sec. 2 Cognitive impairment detection benefit in the Medicare annual wellness visit and initial preventive physical examination
Annual wellness visit—
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.”
Effective date— The amendment made by paragraph (1) shall apply to annual wellness visits furnished on or after January 1, 2025.
Initial preventive physical examination—
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”.
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
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.”
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.”
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.”
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:
“(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—
use an artificial intelligence component (such as a continuous adjustment component); and
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
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.
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.
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—
an analysis of any existing statutory authority for the Secretary to provide payment for prescription digital therapeutics under the Medicare program; and
a description of any additional statutory authority that is needed by the Secretary to expand such coverage.
Definitions— In this section:
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.).
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.).
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)).
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—
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));
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
may not be furnished to an individual without a prescription from a physician.