American Medical Innovation and Investment Act of 2024

This bill amends the Medicare program to add a cognitive impairment detection benefit, improve coverage determination processes, expand coverage for external infusion pumps and home infusion drugs, and issue guidance on payment for artificial intelligence devices and prescription digital therapeutics. Sec. 2, Cognitive impairment detection benefit: The bill requires that during Medicare annual wellness visits and initial preventive physical examinations, detection of cognitive impairment must be performed using tools identified by the National Institute on Aging, with documentation of the tool and results in the patient's medical record. This applies to visits on or after January 1, 2025. Sec. 3, Improving coverage determination processes: The bill limits the duration of Medicare coverage with evidence development to 10 years, after which the Secretary must initiate a redetermination, with exceptions. It also requires the Secretary to respond within 90 days to formal requests for national coverage determinations, specifying any missing information. Medicare administrative contractors must ensure local coverage determinations do not conflict with federal rules. $1,000,000 is authorized for fiscal year 2024 for these changes. Sec. 4, Coverage of external infusion pumps and home infusion drugs: The bill treats external infusion pumps and associated home infusion drugs as meeting the requirement for use in the home if FDA-approved prescribing information says the drug should be administered by a health care professional, a qualified supplier supervises administration in the patient's home, and the drug is infused at least 12 times per year intravenously or subcutaneously. Sec. 5, Guidance on AI devices: By January 1, 2026, the Secretary must issue guidance on Medicare Part B payment requirements for remote monitoring devices that use artificial intelligence and transmit information to health care providers for management and treatment. Sec. 6, Payment for prescription digital therapeutics: By January 1, 2026, the Secretary must issue guidance on Part B payment for prescription digital therapeutics furnished by physicians. Within one year, guidance must be issued to Medicare Advantage organizations on when such therapeutics can be supplemental benefits. A report to Congress by January 1, 2026, must analyze existing statutory authority for payment and describe any additional authority needed.