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CMS Has Proposed a Rule to Require Drug Pricing Transparency in Direct-to-Consumer Television Advertisements

October 17, 2018 – October 17, 2018

The Centers for Medicare & Medicaid Services ("CMS") has proposed a rule to require drug pricing transparency in television advertisements, including "broadcast, cable, streaming, or satellite." As proposed, the rule would apply to advertisements for prescription drugs or biological products distributed in the United States for which direct or indirect payment is available under Medicare or Medicaid. Manufacturers of qualifying drugs would be required to include, at the end of the advertisement, a textual statement showing the drug's wholesale acquisition cost ("WAC") for a typical 30-day supply or a typical course of treatment, whichever is most appropriate. Manufacturers would be required to display the textual statement "in a legible manner, meaning that it is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily."


Prescription drugs and biological products with a WAC that is less than $35 for 30-day supply or typical course of treatment would be exempt from the provisions of the proposed rule.

The Secretary of Health and Human Services would be required to maintain a public list of drugs that were advertised in violation of this rule.
The comment period will end 30 days after the proposed rule is published in the Federal Register. Publication is scheduled for October 18, 2018. Interested stakeholders may submit comments electronically to http://www.regulations.gov. Written comments may be submitted to:

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-4187-P
P.O. Box 8013
Baltimore, MD 21244-8013

The Department of Health and Human Services has issued a press release regarding the proposed rule, available here.

A copy of the proposed rule can be accessed here.

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