The U.S. Department of Health and Human Services (HHS) late Monday released a proposed rule requiring certain direct-to-consumer (DTC) advertisements to disclose pricing information. In particular, the rule would require DTC advertisements for drugs or biologics available via Centers for Medicare and Medicaid Services (CMS) administered health programs to feature the list price for that product via Wholesale Acquisition Cost (WAC) for a typical course of treatment. The proposed rule would apply to products available via Medicare Parts A, B, C, and D as well as state Medicaid programs. Treatments with a list price less than $35 for a typical course of treatment would be exempted from the disclosure requirements. The rule also proposes that CMS keep a public list available for advertisements found in violation of the disclosure requirements.

 

While BioNJ generally supports providing Patients with information necessary to making informed healthcare decisions, we believe the proposed rule is misguided. WAC or list price does not determine the cost a Patient pays for a treatment. Indeed, formularies, tiered networks and other features of the supply chain may have the greatest impact on the Patient share of medication costs. More importantly, providing list price alone could discourage consumers from a treatment that might otherwise be the most appropriate for the Patient's plan of care. Timely access to lifesaving medications is critically important, and the proposed rule could have the unintended effect of keeping Patients from the right treatment at the right time.

 

BioNJ will continue to analyze the Patient impact of the proposed rule. The proposed rule is slated to be published in the October 18 edition of the Federal Register. Interested parties will have 60 days from the date of publication to submit comments on the regulation. BioNJ will be working with our State and national partners to respond to the proposed regulation. Stay tuned for additional information -- including a comment template -- on the proposed DTC rule.