CMS Issues Final Rule on Drug Pricing Transparency

The Centers for Medicare and Medicaid Services (CMS) released the Final Rule on requiring list prices to be included in direct-to-consumer television advertisements for prescription drug that are reimbursable under Medicare or Medicaid. List price is defined as the wholesale acquisition cost (WAC) for a “typical 30-day regimen or for a typical course of treatment” of the drug. Drugs with a WAC, as defined in the rule, of less than $35 are exempt from the requirement. Manufacturers may also include the list price of competitors products if they do so truthfully. Disclosures must be in legible text at the end of the advertisement and must be displayed long enough to be read easily. CMS will maintain a list of products in violation of this new requirement and expects to take enforcement action for those in practicing unfair competition in the form of misleading advertising.