Navigation Links
On track with the FDA -- But what about your coverage and reimbursement strategy?

Food and Drug Administration (FDA) approval or authorization is critical to any new medical technology or treatment's success. But coverage and reimbursement issues can be just as determinative.

"Coverage" is whether there will be payment by an insurer for the product. "Reimbursement" is how much payment there will be if there is coverage.

Unlike ......

Full article >>> edicare has enormous influence over other health plans because once Medicare agrees to pay for a new treatment, other insurers often follow suit.

Roles of the FDA and CMS

Medicare includes several major programs with different rules and administrative systems. All are managed by the Centers for Medicare and Medicaid (CMS). CMS, like the FDA, is an agency within the U.S. D......

Full article >>> uctures pay too low.

In making coverage decisions, CMS considers the following issues:

Does the product have FDA marketing approval or authorization (required except for certain investigational medical devices)?

Is it appropriate for the Medicare population?

Has it been proven medically necessary for the relevant disease or condition?

Does it improv......

Full article >>> ent decisions, such as studies that have both clinical and pharmacoeconomic endpoints (i.e., comparisons to existing technologies or treatments)

Early planning is essential to help ensure that the product will be covered and reimbursed appropriately.

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/12/2017)... ... October 12, 2017 , ... ... a United States multicenter, prospective clinical study that demonstrates the accuracy of ... capable of identifying clinically significant acute bacterial and viral respiratory tract infections ...
(Date:10/11/2017)... ... October 11, 2017 , ... ... Andi Purple announced Dr. Suneel I. Sheikh, the co-founder, CEO and chief research ... Inc. has been selected for membership in ARCS Alumni Hall of Fame ...
(Date:10/11/2017)... ... 2017 , ... Proscia Inc ., a data solutions ... “Pathology is going digital. Is your lab ready?” with Dr. Nicolas Cacciabeve, Managing ... how Proscia improves lab economics and realizes an increase in diagnostic confidence.* ...
(Date:10/11/2017)... ... 11, 2017 , ... A new study published in Fertility ... fresh in vitro fertilization (IVF) transfer cycles. The multi-center matched cohort ... After comparing the results from the fresh and frozen transfer cohorts, the authors ...
Breaking Biology Technology:
(Date:6/30/2017)... 30, 2017 Today, American Trucking Associations ... of face and eye tracking software, became the ... program. "Artificial intelligence and advanced ... monitor a driver,s attentiveness levels while on the ... to detect fatigue and prevent potential accidents, which ...
(Date:5/16/2017)... May 16, 2017   Bridge Patient Portal ... and MD EMR Systems , an electronic ... for GE, have established a partnership to build ... and the GE Centricity™ products, including Centricity Practice ... These new integrations will allow healthcare ...
(Date:4/17/2017)... 2017 NXT-ID, Inc. (NASDAQ: NXTD ) ... of its 2016 Annual Report on Form 10-K on Thursday April ... ... in the Investor Relations section of the Company,s website at ... at http://www.sec.gov . 2016 Year Highlights: ...
Breaking Biology News(10 mins):