This is truly a good thing as I have interviewed companies such as Cook Medical for one in the past and this is one item they is always a bear for them, the FDA stamp of approval is one thing, but coverage, which is what makes the product available is the other big mountain to climb.
I think this decision makes absolute sense from all areas as collaboration is what it is all about. CMS stands to delve deeper into the reasoning for FDA approval and on the other hand the FDA gets a glimpse too at how coverage is decided for the products. Not too long ago I said the FDA stand to become the most connected government entity out there as they touch so many other government and private areas of healthcare and have the responsibility to protect US citizens weighing heavily on their decisions. Here’s one more recent example with the FCC and the FDA working together with wireless devices.
There has been a lot of discussion of late too on what resources the FDA has and where new technology needs to be added. They need the latest and greatest technologies as their educated decision depend on being 100% up to date on what’s happening out there from both the business and consumer side of healthcare.
FDA's Sentinel Initiative Will Need to Embrace Mobility Sooner or Later–Better Sooner Than Later–Data Beyond the Desktop
As a consumer product becomes available, it’s not always that easy and fast to connect it to the healthcare infrastructure as one may think, and yes it pretty much can be done, but it takes time and safety is the all out mission here too. Now if they can start augmenting a non existent recall system, I’ll be happy! BD
Stolen Advair Demonstrates Need for Tag Bar Coding of Drugs – Encrypted Bar Codes Could Identify Stolen and Counterfeits When Scanned With a Cell Phone
(Reuters) - A new process to review medical products at the U.S. Food and Drug Administration in tandem with the nation's Medicare insurance program could help speed up coverage decisions, the FDA said in announcing the move on Thursday.
Under the proposal, the FDA would review and make approval decisions alongside the Centers for Medicare and Medicaid Services, which decides whether and how to pay for new medical products for its elderly and disabled patients once they are approved for the U.S. market.
To start, the agencies proposed a pilot project for devices after both FDA and CMS had time to review public comments on the proposal.