- 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.