CMS finalized the first ACF would be for PrEP, a drug that can help prevent HIV, but which does not actually indicate whether a patient has HIV, excluding generic versions of PrEP (due to significant price differences in the one generic available and multiple brand versions of PrEP). CMS acknowledged excluding from the model factor may encourage use of brand drugs, but were concerned including generics would result in an underpayment for the brand. They believed this would incentivize issuers to limit brand through barriers such as step therapy, which is not consistent with other recent guidance related to preventive services. This guidance proposed to require two oral and one injectable PrEP formulation approved by FDA without cost-sharing and medical management. The final rule also included a discussion on how injectables are accounted for in HHS risk adjustment models. This will be addressed in future guidance, but HHS indicated as long as a service code exists to map to an RXC it is included in calculating risk scores.
The placement of the PrEP ACF within the risk adjustment model hierarchies was also defined, below RXC 1 (Anti-HIV Agents) in the adult models and in HCC 1 (HIV/AIDS) for the child models which do not contain RXCs.
Commenters provided the following for consideration as ACFs: biologic drugs, GLP–1 drugs, and cellular and gene therapies.
Consideration of using the ACF framework to restructure how childbirth, organ transplants, end stage renal disease (ESRD), dialysis, respirator dependance, amputations, autism spectrum disorder, moderate forms of psychiatric illness, and prophylactic interventions such as prophylactic mastectomy are accounted for in the HHS-operated risk adjustment program was included.
Hepatitis C Drugs Adjustment
The market pricing adjustments related to Hepatitis C drugs in the HHS risk adjustment models are proposed to begin phasing out.[5] Specifically, market specific pricing adjustments were developed and applied to EDGE experience to reflect unique pricing changes that resulted from new and generic Hepatitis C, which did not align with other specialty drug categories. Recently, HHS indicated Hepatitis C drug prices are increasing similar to other specialty drug categories. The proposal will use unique market pricing adjustments for these drugs to the 2025 benefit year as with prior years, but to trend for the 2026 benefit year, they will use the specialty drug trend factor. This was finalized as proposed. CMS also further discussed the source of their specialty drug trend factors which consider actuarial experts, relevant URRT submissions, EDGE data, NHEA data, and other sources.
A discussion regarding other high cost drugs such as GLP-1s, sickle cell disease therapies, or other gene and cellular therapies, however, no adjustment was proposed or made at this time.
[5] B. 45 CFR Part 153—Standards Related to Reinsurance, Risk Corridors, and Risk Adjustment – 2. HHS Risk Adjustment (§153.320) – b. Pricing Adjustment for the Hepatitis C Drugs