CMS issued a final Medicare Part D Rule and Part D Call Letter for CY 2019 late yesterday afternoon. Please click here to read the fact sheet on the 2019 Rate Announcement and Final Call letter and please click here to read the Final Rule (CMS-4182-F) Fact sheet.
The final Medicare Part D rule should expand access to more affordable drugs, and the agency outlined new limits on opioids.
The moves on drug costs should reduce cost-sharing for some patients and might provide some savings for taxpayers, but they won’t directly affect the prices drug companies charge.
The final rule for the 2019 Medicare prescription drug program requires plans to have lower maximum co-payments for biosimilar drugs for patients who receive low-income subsidies.
The rule also lets Part D plans immediately substitute newly released generics for brand-name drugs at the same or lower cost-sharing if they come on the market during the plan year.
The rule also finalizes a policy that would let patients receive drugs at whichever pharmacy they prefer.
The final Part D call letter, which includes a number of new policies aimed at tackling the opioid epidemic. Health plans will be required to limit initial opioid prescriptions for acute pain to a maximum seven-day supply.
Of particular interest to specialty pharmacy:
Any Willing Pharmacy Standard Terms and Conditions and Better Define Pharmacy Types
This provision clarifies Part D rules and CMS expectations regarding statutorily-required any willing pharmacy provisions, and revises the definition of retail pharmacy. This provision also establishes deadlines by which Part D sponsors must respond to requests for standard pharmacy contracting terms and conditions.
Manufacturer Rebates and Pharmacy Price Concessions to Point of Sale
The proposed rule In November included a Request for Information soliciting comment on potential policy approaches for applying some manufacturer rebates and all pharmacy price concessions to the price of a drug at the point of sale. While the Trump administration has cheered recent decisions by some national insurers to share savings directly with patients, CMS will not mandate that insurance plans share a percentage of the rebates they negotiate with drug companies directly with patients purchasing the drug at this time, but rather will use the ideas and comments provided in the RFI to evaluate and consider proposals for future rulemaking.
Our Government Relations team is currently reading through the 1156 pages of the final rule and the 250 pages of the call letter and preparing a detailed summary of the changes and implications to specialty pharmacy that we will share with you in the next few days.