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:2/8/2016)... Inc. (NYSE: DPLO) announced today that its new website has gone live. On Thursday, Feb. 4, ... Visit the new site: www.diplomat.is ... ... ... "The goal was to reimagine the website and create a smarter, ...
(Date:2/6/2016)... ... ... The Center for Excellence in Education (CEE) will sponsor a Bite of Science ... 2016. This Bite of Science session, hosted by the Smithsonian-Mason School of Conservation, ... in Front Royal, VA from 5:00 p.m. to 8:00 p.m. The dinner is for ...
(Date:2/5/2016)... ATCC, the premier global biological materials resource ... and life science researchers that are working to address ... CDC website . --> CDC ... a single-stranded RNA virus of the Flaviviridae family, genus ... Chikungunya Viruses. Zika virus is transmitted to humans primarily ...
(Date:2/5/2016)... 5, 2016 On Thursday, February 11, ... for community, health and disaster services, and the ... to enhance care coordination and service delivery for the ... need and to better connect service providers to the ... San Diego has handled more than ...
Breaking Biology Technology:
(Date:1/20/2016)... Jan. 20, 2016   MedNet Solutions , an ... spectrum of clinical research, is pleased to announce the ... achievements are the result of the company,s laser focus ... eClinical , it,s comprehensive, easy-to-use and highly affordable ... --> Key MedNet growth achievements in 2015 include: ...
(Date:1/13/2016)... January 13, 2016 --> ... a new market report titled - Biometric Sensors Market - ... 2015 - 2023. According to the report, the global biometric sensors ... anticipated to reach US$1,625.8 mn by 2023, expanding at ... terms of volume, the biometric sensors market is expected ...
(Date:1/8/2016)... ANGELES and MANCHESTER, United Kingdom ... ("BBI"), a developer of innovative sensor-based diagnostic products, today announced ... financed by new and existing investors.  Proceeds from the financing ... SEM Scanner , a hand-held device for detecting early-stage pressure ... Ireland after receiving CE Mark approval. ...
Breaking Biology News(10 mins):