On February 9, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released two highly-anticipated guidance documents (the “Guidance”) detailing the agency’s proposed implementation of the Medicare Part B (“Part B”) and Medicare Part D (“Part D”) Prescription Drug Inflation Rebate Programs (each, a “Rebate Program” and, collectively, the “Rebate Programs”). The Rebate Programs are administered as part of the prescription drug affordability provisions of the Inflation Reduction Act (the “IRA”), which is aimed at “lower[ing] out-of-pocket drug costs for people with Medicare and improv[ing] the sustainability of the Medicare program for current and future generations.”[1] The IRA represents the most sweeping healthcare legislation passed by Congress since the Affordable Care Act.[2] Please refer to our previous blog post on the IRA.
More Posts
FDA Issues Warning Letter to RightEye, LLC For Misbranding and Adulteration
2023 Top-of-Mind Issues for Life Sciences Companies
FDA Lightens Promotional Restrictions for Certain COVID-19 Drugs with Emergency Use Authorization
Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS
OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies
Biogen Settlement Summary
Charging for Investigational Drugs Under an IND Questions and Answers, Draft Guidance for Industry, August 2022
OIG Advisory Opinion Alert: Yet Another Favorable Decision for Medical Device Manufacturers
Subscribe: Subscribe via RSS