I wish to report on progress made in obtaining coverage of IVIG therapy for SCLS patients in the United States who are covered by Medicare, either because of age or disability.
After fighting a six-year, uphill battle against the Medicare bureaucracy that has involved dozens of individual appeals and even two lawsuits, one of which is still pending, the past 18 months finally have seen progress.
Initially, I had hoped to ensure access to IVIG for all SCLS patients in the United States (and possibly beyond) by obtaining the collaboration of a major pharmaceutical firm for the purpose of applying to the U.S. Food and Drug Administration (FDA) for approval of IVIG as an explicit indication for SCLS, thereby moving all U.S. patients from off-label to on-label use of IVIG. However, that effort failed when the company which had committed later decided not to spend the (relatively small amount of) money involved.
As concerns Medicare, specifically, I likewise attempted to find a universal administrative or legal solution that would apply to all Medicare patients now and in the future, but that too proved impossible, because the law that created Medicare gives it a great deal of authority to decide what treatments to cover and when to do so. Therefore, blanket, forward-looking solutions for off-label treatments are very difficult to find.
However, I was able to petition and, leveraging my lawsuits, get three of Medicare's large, regional contractors to approve the inclusion of IVIG for SCLS in their formularies, or so-called LCDs (for "Local Coverage Determinations") in a total of 31 states plus the District of Columbia, acting on my behalf and also with the cooperation of two patients who reside in those regions.
Therefore, the good news is that the following contractors and their respective IVIG LCDs now explicitly include consideration of IVIG for SCLS patients in the following states and territories:
1) National Government Services LCD A52446, upon physician specification of diagnosis code I78.8 ("Other diseases of capillaries") in Connecticut, Illinois, Maine, Massachusetts, Minnesota, New Hampshire, New York, Rhode Island, Vermont, and Wisconsin.
2) Noridian Healthcare Solutions LCD A57194, upon physician specification of diagnosis code I78.8 in Alaska, Arizona, Idaho, Montana, North Dakota, Oregon, South Dakota, Utah, Washington, and Wyoming.
3) Novitas Solutions LCD L35093, upon physician specification of diagnosis codes I78.8 and D47.2 ("Monoclonal gammopathy") in Arkansas, Colorado, Delaware, District of Columbia, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania, and Texas.
If you are an SCLS Medicare patient residing in some other state not listed above (e.g., California or Florida), and are having your IVIG infusions covered by Medicare because your physician is using a different diagnosis code (usually, one for which IVIG is an FDA-approved indication), please contact me if you are willing to advance our cause by appealing to your Medicare contractor for them to include IVIG for SCLS in their Local Coverage Determinations.
If successful, that appeal would allow current and future SCLS Medicare patients to obtain coverage of their IVIG treatments under their correct diagnostic code, which is I ("Eye") 78.8. Only residents of a state (like California or Florida) can file such an appeal with their respective Medicare contractor, so I can help you prepare, but cannot file, an appeal on your behalf. Such an appeal should not jeopardize your current access to IVIG under some other, pre-approved diagnostic code.
If you are an SCLS patient who will soon be covered by Medicare, and you wish to avoid encountering denials of coverage for IVIG, please share this information with your physician so that they may know how to code their prescriptions for IVIG and thus their billing for Medicare in a manner to facilitate approval of coverage. In case of doubt, feel free to contact me for additional guidance.
I wish everyone a Safer and Happier New Year!