HR 193 · 119th CongressIn Committee

Maintaining Innovation and Safe Technologies Act

Latest updateJan 3, 2025

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.

Health

Sponsor

David Schweikert

Introduced

January 3, 2025

Latest action

January 3, 2025

Legislative Progress

How far this bill has traveled through Congress

Introduced

Bill filed in chamber

Committee

Reviewed & reported

Passed Chamber

House or Senate vote

Passed Both

House & Senate agree

President

Sent to White House

Enacted

Signed into law

Introduced

Bill filed in chamber

Committee

Reviewed & reported

Passed Chamber

House or Senate vote

Passed Both

House & Senate agree

President

Sent to White House

Enacted

Signed into law

Latest Action

Plain-Language Summary

AI Generated

Medicare Part B currently covers remote monitoring devices like continuous glucose monitors under existing payment rules, but these rules were written before artificial intelligence components became common in such devices. Policymakers and device manufacturers have raised questions about whether current payment guidance adequately addresses how to reimburse devices that use AI to continuously adjust readings or recommendations in real time. The lack of clear guidance has created uncertainty for hospitals, clinics, and device makers about which AI-enhanced monitoring tools qualify for Medicare coverage and at what payment rates.

The Secretary of Health and Human Services must issue guidance by January 1, 2027, clarifying Medicare Part B payment requirements for remote monitoring devices that incorporate artificial intelligence components—such as continuous adjustment features—and transmit information to health care providers for patient management and treatment. The guidance will use existing communication channels (such as Medicare administrative contractor notices and policy updates) rather than requiring new regulatory processes. The Secretary will establish which AI-enhanced devices meet coverage criteria and how Medicare should reimburse them, bringing clarity to an area where current payment policy is ambiguous.

The guidance takes effect by early 2027, giving device manufacturers and health care providers roughly two years to prepare. No new funding is required, as the Secretary will use existing Medicare administrative resources and communication infrastructure. Once issued, the guidance will likely increase Medicare coverage for qualifying AI-enhanced remote monitoring devices, potentially expanding patient access to these technologies while establishing consistent payment standards across the program. Providers will gain clarity on billing practices, and device manufacturers will have a defined pathway for bringing AI-enhanced monitoring tools to market with Medicare reimbursement certainty.

Key Provisions

1Directs the Secretary of Health and Human Services to issue guidance by January 1, 2027, on Medicare Part B payment requirements for remote monitoring devices that use artificial intelligence components and transmit information to health care providers.
2Requires the guidance to address payment for devices with continuous adjustment features or other AI components that support patient management and treatment.
3Specifies that the Secretary shall use existing Medicare communication mechanisms to distribute the guidance rather than establishing new regulatory procedures.

★ Why this matters

Clear Medicare payment guidance for AI-enhanced monitoring devices removes uncertainty that currently discourages adoption of these technologies in clinical practice. Providers will know which devices qualify for reimbursement and at what rates, enabling them to confidently invest in and deploy AI-enhanced remote monitoring. Patients with chronic conditions like diabetes may gain faster access to more sophisticated monitoring tools. Device manufacturers will have a defined regulatory pathway, potentially accelerating innovation in AI-enhanced medical devices.

● Who this affects

Medicare beneficiaries with chronic conditions requiring remote monitoring (particularly those with diabetes using continuous glucose monitors) stand to benefit from expanded device options. Health care providers and hospitals that treat Medicare patients will gain clarity on billing and coverage for AI-enhanced monitoring devices. Medical device manufacturers developing artificial intelligence-enhanced remote monitoring technologies will have explicit guidance on Medicare reimbursement eligibility. The Centers for Medicare & Medicaid Services will implement the guidance through existing administrative channels.

Bill Text

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<DOC>

119th CONGRESS
  1st Session
                                H. R. 193

To direct the Secretary of Health and Human Services to issue guidance 
   on payment under the Medicare program for certain items involving 
                        artificial intelligence.

                    IN THE HOUSE OF REPRESENTATIVES

                            January 3, 2025

Mr. Schweikert 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 direct the Secretary of Health and Human Services to issue guidance 
   on payment under the Medicare program for certain items involving 
                        artificial intelligence.

    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 ``Maintaining Innovation and Safe 
Technologies Act''.

SEC. 2. GUIDANCE ON MEDICARE PAYMENT FOR CERTAIN ITEMS INVOLVING 
              ARTIFICIAL INTELLIGENCE.

    Not later than January 1, 2027, 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.
                                 <all>

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Alma Adams

D-North Carolina · District 12

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