A side-lined demonstration testing payment approaches for drugs that received accelerated approval could end up on the chopping block now that President Trump has rescinded a 2022 executive order by former President Biden intended to lower drug prices by developing payment models in Medicare and Medicaid.
Deciphering Trump’s Executive Order On Medicare, Medicaid Payment Models
Since CMMI does not need an executive order to conduct demonstrations, President Trump's executive order does not appear to mean the models developed under the Biden Administration will be suspended, yet.
More from Medicare
More from United States
• By
Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.
• By
Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.
• By
The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.