'Perverse' new payment model for Part B drugs may test the limits of its innovation center’s waiver authority and has already drawn lawsuit threat.
The Medicare Part B payment model being planned by the Centers for Medicare and Medicaid Services has drawn threats of legal and congressional action even in its current state as a proposed rule, demonstrating the strength of the opposition against it.
Announced by the agency March 8, the payment model for Part B drugs is envisioned as a large-scale initiative that...
Create an account to read this article
Already a subscriber?
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served by hearing from an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.
The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.
Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.
Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.
Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.
Complaints about TPAs offer an explanation of why self-funded employers continue to use the big three PBMs despite concerns about those relationships. Proposed solutions include banning retaliatory fees and data withholding.
