LDT. Not a sandwich, not a drink but laboratory developed tests. On Monday, the Food and Drug Administration (FDA) put out the long anticipated final rule on LDTs. If you’re more of a prescription drug policy person, get used to following LDT policy. We’ve moved from tests that are nice but, even if you have…
Updated 8/8/24. I live in a headspace that assumes everyone is up to date on the nuances of things and that I don’t need to write about it because it’s old news. And then I read this article in the Pink Sheet on how Medicare-negotiated prices may not get favorable coverage and realized that nope,…
PDAB-adieu. This week Governor Youngkin vetoed a bill that would have established a prescription drug affordability board (PDAB) in the state. The PDAB would have had authority over state-sponsored and state-regulated health plans. Younkin said that the PDAB would have determined drug availability solely on cost rather than unique patient needs and the opinions of…
Ruling It. Yesterday afternoon, the Centers for Medicare & Medicaid Services released the MA/Part D final rule. Personally, most of it was not up my alley but I did read over the changes to the changes to an approved formulary sections. In December 2022, CMS proposed allowing immediate substitution of interchangeable biosimilars or branded biologics…
Late Monday, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2025 Rate Announcement for Medicare Advantage and the Medicare Prescription Drug Program (Part D) as well as the CY25 Part D Redesign Program Instructions. I was about to get on an airplane and instead of watching a movie, I figured what sounds like a…
If you’re one of those people who is working from the couch today, I salute you. It really is the most fun day of sports. I was mocked for the way I picked my bracket (where wouId I rather live?) but I had a clean bracket until Kentucky. I blame my newfound like of bourbon.…
Happy International Women’s Day. Best display of International Women’s day I’ve ever seen was in Russia when I was studying abroad. They took it SERIOUSLY. Not just a LinkedIn Holiday. Cat-astrophe? No, just a political speech – not reality. President Biden talked about increasing the number of negotiated drugs up to 50 a year. Not…
It took my until 5 pm on Thursday to figure out why there was a frog on the Microsoft tool bar. Leap year. Frog. Leap. Sigh. I prefer not. Congress seems to have hit the pause button (at least temporarily) on pharmacy benefit manager (PBM) reform. And that sort of felt okay because, realistically, things…
Gross to Net, a Saga. As soon as I saw Adam Fein’s Drug Channels article on Gross to Net in Part D redesign, I knew it would throw off my day. It was just catchy enough to cause a buzz and get the attention of Heads of Market Access at pharmaceutical companies and start the…
On March 7 the District Court of New Jersey will hear oral arguments from 4 pharmaceutical companies against the Inflation Reduction Act (IRA) in one day – BMS, Janssen, Novartis and Novo Nordisk. When the arguments line up and time is ticking, get it done. All four companies have drugs that are part of the…