Despite the brouhaha over the USPSTF and preventive services, especially HIV-related services, under the Affordable Care Act, CMS has gone ahead and issued instructions for HIV PrEP in Medicare patients.
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Note: I think I have the fact patterns correct, but this is not my chief policy expertise, and I've worked from several web resources. E.g. see the NCA, "Transition of Coverage of Oral PrEP Medications from Part D to Part B."
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Medicare made the PrEP coverage decision following endorsement of PrEP therapy by USPSTF. CMS can write NCDs that create new preventive benefits, if they are endorsed by USPSTF. This one was tricky, because it is an oral medication and Medicare Part B does not normally cover tablets which the patient takes home. The HCPCS codes include the drugs J0739, J0799, J0750, or J0751. Note that a number of these are injectible drugs (J codes). Oral therapies include Truvada and Descovy, injectibles include Apretude and others. Oral drugs usually use NDC codes.
The benefit, besides tablets or injections include up to 8 counseling visits and up to 8 screening blood tests per year.
There are no age limits but the physician must determine the patient is "at increased risk of HIV."
Benefit Category Puzzle
After a public request letter from VIIV in February 2022, the decision process was opened in January 2023, and finalized not in fall 2023, but in fall 2024. That’s approaching 3 years. See the complex timeline in section IV of the national coverage analysis.
Under "Benefit Category," despite the fact that self-administered drugs (esp. tablets) are not a Part B benefit, CMS notes that Congress gave nonspecific or unrestrained abilities to create "other preventive services" and therefore, the oral drug exclusion rule does not apply.
- (For comparison, oral anti-emetics in Part B required a statutory benefit, too (1861(s)(2)(T).)
CMS writes, “To bill for oral HIV PrEP drugs under Part B, a pharmacy must be enrolled in Medicare as either: 1) a durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier (CMS855S), or 2) a Part B Pharmacy supplier (CMS-855B).”
See article MM13843, May 2, here:
The NCD language (core language) is here:
https://www.cms.gov/files/document/r13209ncd.pdf-0
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CED for "Medicare-age data" used inconsistently
From my viewpoint, CMS is inconsistent in making complaints that a service isn't studied enough in Medicare patients. The whole TCET apparatus (temporary coverage for emerging technologies) is set up for CED because there supposedly aren't enough Medicare patients studied at the point of FDA approval. OK, well... very few Medicare age patients were studied in HIV PrEP studies (see tables in NCA), nor were there special studies of Medicare disabled persons (e.g. blind or ESRD).
Since the mean age was often around 25, CMS could easily have raised the spectre of not enough Medicare-age data (like, none) and therefore, required CED. This time around, CMS simply dealt with the issue by not mentioning the issue.
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Equity Vintage 2024
The NCD, from last fall, has a section on health equity issues, which might be less likely to be written in the same way in the current administration. See: HIV disproportionately affects racial/ethnic minorities, transgender women, and MSM, and equitable provision of PrEP to populations at highest risk of HIV acquisition is not occurring [etc].
