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Access to IVIG for SCLS under U.S. Medicare

aporzeca Message
1 Jan 2021, 01:54 PM

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!

DavidS Message
2 Jan 2021, 10:33 AM

Thank you so much for this invaluable contribution Arturo. My husband turns 65 in a year and a half, and we live in New York. We greatly appreciate all you've done for this community.

rnuara Message
2 Jan 2021, 12:22 PM

Arturo, Once again we owe you a huge debt of gratititude.  This is wonderful news for the community and for me, as I turn 65 next year. Thank You for everything that you do.

Barney Message
2 Jan 2021, 01:07 PM

Arturo - words can't express the thanks for your work!  Any recommendations for states like North Carolina? And would this encourage a person to relocate for retirement in your opinion?  I am currently 54 yrs old and being covered well by my employers plan (BCBS; Privigen every 4 weeks) but feel stuck in this role vs looking for more pleasant work opportunities.   I am having excellent results aside from some low WBC counts that is making my doctor question how long I should continue.   I did discuss this with Dr. Druey and he was very helpful. Thanks again - your work is greatly appreciated. Marc 

Arielbatt Message
3 Jan 2021, 04:09 PM

Thank you Arturo for all the contributions you always make for our community.  I hope that little by little the patients from the states that have not yet approved it, will show solidarity with the cause, and you will be able to accompany them in the claim.  Although I do not live in the US, and luckily I never had a problem with medication thanks to my health insurance, that is where everyone looks.  Thank you again.  May the universe conserve your energy and dedication.  Happy New Year to you and to the entire community.  Prompt vaccination for all.

catsanmice Message
8 Jan 2021, 05:34 PM

Thanks and blessings, Arturo, for going above and beyond in your/our fight. A truly awesome endeavor and accomplishment.