Medical Device Innovation Consortium Sets Priorities To Advance Reg Science

Medical Device Innovation Consortium Sets Priorities To Advance Reg Science-graysheet: The Medical Device Innovation Consortium is officially up and running and planning its priority projects. The public-private partnership was formed in December 2012 with the goal of advancing medical device regulatory science. The MDIC board, which held its first meeting in late February, includes leaders from medical device manufacturers, FDA, the National Institutes of Health, CMS and patient advocacy groups

FDA's new global cardiovascular registry to start with transcatheter heart valves

FDA's new global cardiovascular registry to start with transcatheter heart valves-massdevice: The FDA plans to launch a global cardiovascular medical device registry, with initial efforts to focus on coordinated efforts to monitor transcatheter heart valve technology.The federal watchdog agency will host a public meeting later this month to discuss goals and strategies for organizing such an effort, which the FDA is calling the "International Consortium of Cardiovascular Registries."

MedPAC: ACOs Are Locating Mostly In Areas With High MA Penetration

MedPAC: ACOs Are Locating Mostly In Areas With High MA Penetration-insidehealthpolicy: Accountable Care Organizations are locating primarily where Medicare Advantage is strong, according to Congress' Medicare advisers, who on Thursday (April 4) will review research on the some 250 ACOs, but there are some exceptions that could be interesting, according to a consultant. Maps of ACOs and MA plan penetration, based on 2012 data, show areas of inconsistency on both coasts and in Mountain states.

Questions Loom On Bonus Structure As House GOP Floats Updated 'Doc Fix'

Questions Loom On Bonus Structure As House GOP Floats Updated 'Doc Fix'-insidehealthpolicy: Some 80 percent of physicians likely would need to be eligible for bonuses to get provider groups to support legislation replacing the Sustainable Growth Rate formula, Rep. Mike Burgess (R-TX) told Inside Health Policy on Wednesday (April 3) as House Republicans floated an updated version of their “doc fix.” The GOP plan is to cut the SGR's base pay rate and give bonuses to physicians who meet as-yet determined performance goals to make up for that cut, he said, but questions remain on how the bonus system would be set up. Burgess also noted that the legislative outline does not prohibit doctors from charging seniors more for Medicare services, which has been called “balance billing” but which Burgess calls “fair billing.”

Medicare buy-in a budget solution?

Medicare buy-in a budget solution?-politco: To get to a budget deal, could Washington buy in to a Medicare buy-in?That’s the question left hanging by a recent Urban Institute paper which maps out one path to bridge the partisan divide over Republican demands that the eligibility age for Medicare be adjusted upward from 65 to 67 so as to conform with Social Security.The GOP would get the higher age it wants. But in turn, it must agree to allow 65- and 66-year-olds — who would be left out in the cold — to buy in to Medicare until they are 67.

FDA issues new guidance on medical device user fee refunds and exceptions

FDA issues new guidance on medical device user fee refunds and exceptions-massdevice: The FDA issued new guidance this month detailing cases in which a medical device manufacturer may be eligible for a refund of the user fee paid for agency review.The federal watchdog agency described user fee protocols for both 510k and premarket approval applications, laying out the general guidelines the FDA will follow in determining whether the applicant may be able to request a user fee refund.

The FDA sends medtech reviewers into the field | MassDevice.com On Call

The FDA sends medtech reviewers into the field-massdevice: MASSDEVICE ON CALL — The FDA is looking for medical device companies to participate in its "Experiential Learning Program," so that the agency's reviewers can get a 1st-hand look into medtech design and manufacturing. Participating companies would host tours for healthcare regulators as part of a training mechanism to give the reviewers a sense of the medtech development life-cycle and the "challenges faced throughout development, testing, manufacturing, and clinical use," according to an FDA notice.