Tuesday, November 27, 2018

Very Brief Blog: HHS Floats New Part D Pricing & Policy

Briefly, on November 26, 2018, CMS released proposed new rules that would somewhat raise competitive pricing pressure among Part D plans, and shift some existing policies such as those surrounding protected drug classes like HIV drugs.
  • Trade press on new Part D policy here.
    • Pharma stakeholders argue:
    • Part D already handles protected drug classes economically, here.  (Study by Avalere).
    • However, DOJ continues to act against Part D suppliers for illegal patient supports and rebates, here, here.  $360M settlement regarding Tracleer and other oral drugs.
  • CMS announcement on new Part D policy here.
  • Proposed rule in full, here.
    • Comment open to January 25, 2019.
    • Final rulemaking in spring 2019 for CY2020.
    • Rules apply to direct Part D plans as well as the many beneficiaries who get "Part D" benefits through Part C - Medicare Advantage.
    • For separate Part C rules for physician-administered drugs (aka Part B drugs) under step therapy see HHS proposals in August 2018, here.
Recall that on October 25, President Trump gave a press conference in person at HHS discussing potential, and more speculative, possible future changes to Medicare Part B drug pricing such as indexing US Medicare prices to European prices; entry point here.  

The proposed rule, like the October announcement, are keyed back to the May 2018 "Trump Administration Blueprint to Lower Drug Prices."  Here, here, here.