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.
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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?
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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.