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M-19: An Evaluation of Comments to the CMS Proposed Drug Price Transparency in Direct-to-Consumer Television Advertising Rule

Poster Presenter

Achint Raince

Student
Ernest Mario School of Pharmacy
United States

Objectives

To evaluate opinions, concerns and suggestions to the proposed rule issued by the Centers for Medicare and Medicaid Services (CMS) to require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products to include the medications’ Wholesale Acquisition Cost (WAC).

Method

Comments to the proposal were reviewed in January 2019. Each commenter’s background, understanding of WAC, opinion of the proposal, and concerns or suggestions towards the proposal were collected and assessed. The data were evaluated using descriptive statistics.

Results

CMS posted the proposed rule on October 18, 2018 and sought comments until December 17, 2018. During this time period, 146 public comments were received from numerous parties and published online. Commenters were classified using the following categories during data analysis: unspecified (23.3%), healthcare organization (21.9%), non-profit organization (11.6%), industry representative (8.9%), third-party payer (8.2%), healthcare provider (6.8%), academia (6.2%), consumer (6.2%), and government or legal representative (5.5%). The most common concerns expressed included potential confusion by patients regarding the actual out-of-pocket cost and what WAC represents (36.3%), under-treatment or inappropriate treatment options based on list prices without context (34.2%), and inappropriate use of WAC as a tool to determine patient cost (32.2%). Support for the proposal was distributed rather evenly across groups with against (34.2%), supportive with contingency (33.6%), and fully supportive (30.8%). Two commenters did not specify an opinion. WAC was understood by a majority of commenters against the proposal (84%) and those supporting with contingency (63.3%) compared to roughly one quarter of commenters fully supporting the proposal. In addition, 86.8% of commenters indicating that the proposed rule would not reduce drug prices, compared to 31.6% of those expressing that the proposed rule would reduce drug prices, understood WAC. Five of eight commenters who were unsure if the proposal would reduce drug prices demonstrated an understanding of WAC. Sixty-one commenters did not state if the proposal would reduce drug prices. The most common suggestion beyond the proposed rule, provided by a quarter of commenters, was to develop and refer patients to tools allowing them and providers to access real-time cost information.

Conclusion

Drug Price Transparency in DTC TV Ads Rule commenters expressed fairly well-distributed opinions among three categories: support, support with contingency, and opposition to the rule. However, the majority of those fully supporting the rule or indicating that the proposal would lead to a reduction in drug prices did not demonstrate an understanding of WAC based on their comments. Those who demonstrated an understanding of WAC were more likely to be against the proposal and also felt that it would not lead to a reduction in drug prices. The comments provided to the proposed rule indicate that purely using the WAC to convey drug prices likely would not be the most accurate mechanism and likely would not fulfill the intended goal. The most common concern among commenters was that this could mislead consumers and result in suboptimal treatment. A popular suggestion among commenters to ameliorate this concern is to make real-time cost information available to patients and providers. CMS should carefully consider these comments, as well as other mechanisms, to identify the best approach for providing true transparency to consumers and ultimately lower spending.