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!

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.

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.

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 

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.

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

My husband had to start with Medicare in June 2022 and I'm happy and relieved that due to your amazing work Arturo, Medicare is paying for the infusions.

Our hemotologist was also thankful for your instructions here regarding what diagnosis code to use in our state.

Our hemotologist also referred us to the gal in his office that takes care of Medicare approvals all day long. 

She guided me in our selection of what type of Medicare coverage that was more likely to cover infusions.

Specifically rather than select Medicare Advantage Part C which is an alternative to Original Medicare, we chose the Original with a Supplement Plan. 

She said that Advantage Part C means that the insurance carrier has a lot more leeway and may not cover the expensive infusions.

The Supplement Plan costs us more than a Part C plan in our monthly contribution for the coverage, but oh so worth it!

Our Original Medicare policy approves and pays a little for the infusions, and I believe due to the fine print the Supplement Plan is required to pay for the difference.

Thanks again Arturo! I'm sure you are responsible for saving many lives!

Rebekah Sellers

Wonderful work, Arturo! I ran into similar barriers in my research, but you have persevered and made remarkable progress.

What are your thoughts regarding traditional Medicare vs. Medicare Advantage plans vis a vis  SCLS access to IVIG coverage?This may be very important for those new to Medicare and those making choices during open enrollment periods in the States.

Though this is a US issue, it may be informative for our global cohorts when attempting to secure coverage from national and private insurers.

Again, bravissimo!

Susan

 

Rebekah, I’m glad to hear that your husband’s transition into Medicare in upstate New York went well, and that he didn’t suffer any interruption in coverage and thus treatments.  His experience would have been very different three or more years ago.

Susan, the work I did was to ensure coverage of IVIG for SCLS patients enrolled in traditional Medicare – namely, for the processing of Part A (hospitalization-related) and Part B (outpatient medical) claims – in 3 of the country’s major jurisdictions, see details above in my post dated 1/1/2021.

Therefore, I will never myself choose a Medicare Advantage plan over traditional Medicare, because I would probably have to fight it out with them the way I had to fight for coverage before I retired from my employer-provided insurance programs with companies like Aetna, Blue Cross Blue Shield, and United Healthcare.

Where I do have choices is when it comes to Part A and B supplemental insurance programs and Part D Rx insurance programs covering drugs and medications (other than IVIG).

And to my initial and happy surprise, under traditional Medicare plus a supplemental insurance program, my IVIG is provided without ANY deductibles or copays!  Does it get any better than that?

Things are different in other Medicare jurisdictions from Oregon and California to the Carolinas and Florida, however, because we need for at least one SCLS patient transitioning to Medicare in those states to petition for coverage of IVIG for SCLS to their respective Medicare contractor.

Consequently, in those states it may be advisable to enroll at first in a Medicare Advantage plan and then switch to traditional Medicare once Medicare coverage approval is obtained. 

Arturo, I couldn't agree more. Medicare Advantage contractors and claims processers are for-profit and as such are in the business of making a profit via denial of claims. The marketing of such plans is extremely misleading and nigh unto fraudulent.

As a health care and hospital attorney I have always recommended traditional Medicare. SCLS patients must never be limited in choosing their doctors and specialists.

I, too, have had Plan F United Healthcare Supplementary insurance. I could never afford the high cost of IVIG copays without it.

Best wishes to you and, again, thank you for your hard and successful work.

Susan