FDA Approval Does Not Mean What You Think It Does!

[Manouche]

“The Department of Health and Human Services’ (DHHS) Food and Drug Administration (FDA) is well known to Americans, as are their terms “FDA approval” and “off-label usage.” Unfortunately, the inappropriate usage of these terms has created confusion because of misinterpretation, which has damaged the doctor-patient relationship, as well as the incorrect conclusion that FDA approval enabled product use and insurance (Medicare) reimbursement for both the product and physician rendered services. The unintended consequences of misuse of these terms by companies, the media, and individuals have inappropriately interfered with the delivery of health care. Furthermore, FDA approval does not determine product reimbursement, which is solely determined by CMS [Centers for Medicare and Medicaid; formerly, Health Care Financing Administration (HCFA)], which, after FDA product approval, determines whether or not reimbursement should be provided. However, CMS’ non-uniform regional reimbursement policy enables Medicare contractors’ to use selective and indiscriminate reimbursement, which limits patient access to selective FDA approved products, according to their area of domicile.”

hudson.org/research/7264-fd...

[Aquinas]

Thank you very much for your detailed explanation, which it is most helpful to know.

[hunter5582]

Thanks for posting this informative article. This is precisely the issue that many of us on Medicare are facing with Besremi and the alternative medications. It is also important to understand the distinction between "FDA Approved" and "Off-label" use of a medication. Drugs like Pegasys and hydroxyurea may be "off-label" for treating MPNs, but that does not mean that their use is inappropriate. There is research and practice guidelines that make these medications first-line treatment options. I was able to get Pegasys approved through my Medicare plan with no problem. It is on the formulary. The fact that it was off-label for PV did not matter.

Wishing success to all who are seeking access to Besremi or any other medication in their healthcare system.

[EPguy]

A few more similar quotes here:

<<reimbursement may be limited to only FDA-approved indications, and only occurs after CMS deems a product to be reasonable and necessary. However, CMS’ determinations are not uniform throughout the country.>>

We should have no problem showing the reasonable and necessary, with a logical next phrase being "for a better outcome."

<<However, all Medicare-covered Americans do not receive the same insurance coverage from their local Medicare contractor, and, thereby, the same care.>>

<<people from different parts of the country can receive different care because of different local reimbursement decisions>>

Consistent message of inconsistency. Seems the specific contractor makes a difference.