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:6/24/2016)... -- Regular discussions on a range of subjects including policies, debt ... said Poloz. Speaking at a lecture to the ... pointed to the country,s inflation target, which is set by ... "In certain areas there needs to ... goals, why not sit down and address strategy together?" ...
(Date:6/24/2016)... ... June 24, 2016 , ... While the majority of ... the Cary 5000 and the 6000i models are higher end machines that use the ... of the spectrophotometer’s light beam from the bottom of the cuvette holder. , ...
(Date:6/23/2016)... (PRWEB) , ... June 23, 2016 , ... ... the release of its second eBook, “Clinical Trials Patient Recruitment and Retention Tips.” ... and retention in this eBook by providing practical tips, tools, and strategies for ...
(Date:6/23/2016)... 2016   Boston Biomedical , an industry ... to target cancer stemness pathways, announced that its ... Drug Designation from the U.S. Food and Drug ... including gastroesophageal junction (GEJ) cancer. Napabucasin is an ... cancer stemness pathways by targeting STAT3, and is ...
Breaking Biology Technology:
(Date:3/31/2016)... March 31, 2016   ... or the "Company") LegacyXChange is excited to ... its soon to be launched online site for trading ... ) will also provide potential shareholders a sense ... technology to an industry that is notorious for fraud. ...
(Date:3/23/2016)... March 23, 2016 ... Sicherheit Gesichts- und Stimmerkennung mit Passwörtern ... (NASDAQ: MESG ), ein führender Anbieter ... Unternehmen mit SpeechPro zusammenarbeitet, um erstmals dessen ... wird die Möglichkeit angeboten, im Rahmen mobiler ...
(Date:3/21/2016)... , March 22, 2016 ... recognition with passcodes for superior security   ... a leading provider of secure digital communications services, today ... biometric technology and offer enterprise customers, particularly those in ... facial recognition and voice authentication within a mobile app, ...
Breaking Biology News(10 mins):