It seems like yesterday that Eric Topol had a new Op Ed in NYT about the revolution in primary care offered by AI (here).
David Schweikert (R-AZ) has introduced a bill that would allow AI to qualify as a practitioner and issue legal prescriptions, under certain constraints.
See excellent coverage at Policy & Medicine by Thomas Sullivan - here. (Also MedpageToday). The bill, HR 238, is only a few sentences long. According to Sullivan, it was also introduced in the prior session of Congress.
- H. R. 238 To amend the [FDA Act] to clarify that artificial intelligence and machine learning technologies can qualify as a practitioner eligible to prescribe drugs if authorized by the State involved and approved, cleared, or authorized by the FDA, and for other purposes.
Like physicians or nurse practitioners, the AI entities would need to be licensed at the state level.
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While prescriptions could be written under FDA law, CMS law intervenes as well, Medicare generally requires diagnostic orders to be made by the treating physician (with a few exceptions for radiologists and pathologists) and drug orders (Part B) to be incident to a physician. In Part D, drug ordering persons must have an NPI and (since a change in 2019) do not have to be enrolled in Medicare. For Part D see 42 CFR § 423.120(c)(6).
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AI Corner
Chat GPT found 42 CFR 423.120(c)(6) in a half second for me.
Sidebar on the 2019 change re: Part D Rx requirements - here.
