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Maximizing Patient Access: ATAP Action Network's Recommendations for Medicare Drug Price Negotiation Program

The Alliance for Transparent and Affordable Prescriptions (ATAP) Action Network thanks the Centers for Medicare and Medicaid Services (CMS) for the opportunity to provide feedback on implementation of the Medicare Drug Price Negotiation Program (“the Program”) and the mechanics of the new “maximum fair price” (MFP) paradigm.

ATAP was created in 2017 with a mission to address prescription drug costs and patient access to affordable treatment by regulating PBM practices and reforming the drug industry through educational outreach and grassroots advocacy initiatives at both the state and federal levels. Driven by the reality that many patients struggle to afford their medications, the physician and patient advocacy organizations joined to expose the abusive practices of PBMs.

We will limit our comments to highlighting the potential formulary impacts of the Program, and suggesting a solution that will mitigate those impacts. The Inflation Reduction Act requires that Part D plans cover drugs with an MFP. Presumably, the goal of this coverage requirement was to maximize the number of beneficiaries who can access the MFPs and thus benefit from MFP-level cost-sharing. However, the statute does not prohibit utilization management on MFP drugs, nor does the statute specify where an MFP drug must be placed on formulary. As we’ve seen in the commercial market, “coverage” becomes an empty word when the covered medication is subject to Kafkaesque utilization management protocols that render it functionally non-covered.

Since the MFP mechanism will not apply to drugs with generics/biosimilars, this issue will become especially important for disease states in which much of the pharmaceutical competition is among brands. If drugs A, B, and C all treat rheumatoid arthritis, but only Drug A has an MFP, the PBMs may prefer options B and C, because these will present income potential for them. Already, plans use utilization management to drive beneficiaries to the drug with the highest rebate potential, which means that beneficiaries may be pushed to high list price options over MFP options.

Unless CMS controls for this dynamic, a smaller number of beneficiaries will benefit from MFPbased cost-sharing than the agency and the law’s drafters might hope. To ensure that the statutory coverage requirement realizes its full potential, we urge CMS to prohibit any utilization management on MFP drugs. The stated goal of utilization management is to drive down costs, but the establishment of an MFP will greatly reduce the need to control costs via utilization controls on selected drugs. A regulatory prohibition on utilization management for MFP drugs should not result in increased costs. In fact, such a prohibition could result in prescribers and patients choosing MFP options over non-MFP options when clinically appropriate, driving program spend towards the lowest-cost option and maximizing the reach and impact of the MFP program in Medicare.

In addition, we want to urge CMS to exercise particular caution with regard to medications that have both self-administered and provider-administered formulations. Stelara, which is on the list of the first ten Part D drugs selected for the Program, is an example of such a medication. Already, beneficiaries who need the provider-administered version are unable to access that version, since it has been placed on the Self-Administered Drug Exclusion list. In the CY 2024 Medicare Physician Fee Schedule proposed rule, CMS issued a request for information to determine whether the process surrounding the SAD Exclusion list requires changes, in order to protect access for those beneficiaries who, for clinical, socioeconomic, or other reasons, need access to the provider-administered version of a medication. We urge CMS to avoid exacerbating that existing access crisis as it establishes MFPs for Part D medications that also have a provideradministered formulation.

In closing, we want to reiterate our appreciation for the opportunity to provide input as CMS implements this new, complex program, and we hope that you will consider us a resource on the issues discussed herein.

Sincerely,

Angus B. Worthing, MD, FACP, FACR

President ATAP-Action Network

Dan Rene