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 a diagnosis, there is no treatment to costly products, and we want some sense of what might work best ASAP. And Theranos should give some pause. I am thinking of digging in more and writing a blog on the rule, but I have some paint to watch dry first. Kidding. Sort of.
Quick thoughts –
- An FDA rule that is over 500 pages. They are learning lessons from their Centers for Medicare & Medicaid Services friends.
- LDTs have 4 years to comply. There is a big exception — LDTs already on the market are grandfathered in.
- Expect lawsuits because it seems unclear if FDA has authority over LDTs. FDA took the medical device authority and put the LDT under that because Congress didn’t step up.
No Diggity. Wait for it… MMIT says that Medicare Part D plans are going to be tightening the reigns on GLP-1 coverage. I would wonder what they were doing if they didn’t. With millions of Medicare beneficiaries likely to be eligible for coverage (3.6 million, 7% KFF), of course they are putting up the barriers.
PORTAL to the Future? Dan Ollendorf and team dig into how Medicare could look at drug negotiation. Yes, the legislation and subsequent policy have some sense of process for what negotiation will consider but when you have 10 drugs with offers rejected, you begin to wonder. Hallway chatter at Asembia… so far might be hard to tell what Medicare is using to get to their $.
IP, You Know Me. The politics of IP. Best line of the National Review article –The USPTO does not hand out patent rights willy-nilly.
Are you down with DTC? Health Affairs explores if Direct to Consumer ads for prescription drugs should be banned. The United States and New Zealand are the only industrialized countries that allow it.
HAY Yeah. The Haystack Project added Dr. Janet Woodcock to its roster of advisors. Haystack represents rare and ultra rare patient advocacy organizations. Alone they are just straw, waiting to noticed – together a haystack and powerful.