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saidie10

Filing Appeal with BCBS for IVIG Coverage

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I was sick when I got the letter and I know the case worker at the Hospital is going to help us fight this but BCBS of Texas has denied covering our DS8's fifth IVIG. They covered the first four but denied this one saying "the proposed services are unproven in available peer-reviewed scientific literature to be safe, effective and durable." Well I can tell them I don't need any peer-reviewed scientific literature to know these have helped my son tremendously. He is off the zoloft completely and the OCD is all but gone! We see tremendous improvements in his secondary condition of ADD/ADHD and the improvements in his fine motor skills are remarkable. The tics seem to be the hardest to get rid of and exposure to strep certainly doesn't help, but the IVIG's have been a lifesaver for him.

 

Any advice on how to fight this?

 

And on a crazy other note, the approval process for my DS6's first IVIG went extremely smoothly because he has United Healthcare and they state that they cover IVIG specifically for PANDAS. How messed up is our healthcare system and insurance?

 

Thanks for reading and offering any advice if you have had to fight insurance.

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I was sick when I got the letter and I know the case worker at the Hospital is going to help us fight this but BCBS of Texas has denied covering our DS8's fifth IVIG. They covered the first four but denied this one saying "the proposed services are unproven in available peer-reviewed scientific literature to be safe, effective and durable." Well I can tell them I don't need any peer-reviewed scientific literature to know these have helped my son tremendously. He is off the zoloft completely and the OCD is all but gone! We see tremendous improvements in his secondary condition of ADD/ADHD and the improvements in his fine motor skills are remarkable. The tics seem to be the hardest to get rid of and exposure to strep certainly doesn't help, but the IVIG's have been a lifesaver for him.

 

Any advice on how to fight this?

 

And on a crazy other note, the approval process for my DS6's first IVIG went extremely smoothly because he has United Healthcare and they state that they cover IVIG specifically for PANDAS. How messed up is our healthcare system and insurance?

 

Thanks for reading and offering any advice if you have had to fight insurance.

 

 

I would include how he has improved. Document exactly what you just wrote above, and more. Also, if I'm not mistaken, I remember reading something on the forum last year that mentioned that if you can show that another company covers it for that condition, it might help. Does anyone remember that thread? It was specifically about United Healthcare covering it, and others that don't

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Hi Saidie10,

 

I addressed some of this in my post about our insurance appeal a little while ago: link to post

 

Based on what you said in your post I would first counter their claim about the absence of peer reviewed lit -- specifically: Swedo's article was published in the Lancet, which is peer-reviewed and meets their criteria (some BCBS groups use the Lancet as an example of the type of journal that meets the criteria). There are others, too...

 

I'll paste some copy from our appeal docs below. If what you need isn't in there, feel free to ask me for tips or samples from our letter.

 

Also, a question: were your previous IVIGs ordered for the same condition? Or did the Drs order for PANS this time and Immune Deficiency or something else last time? If it's the same diagnosis code, I would add something to your letter questioning their denial of coverage for the same treatment for the same condition that was already covered (and thus considered by the insurer to be both medically necessary AND "proven safe, effective, and durable") FOUR TIMES. The writing will be on the wall for them: there certainly isn't less available evidence for the treatment at this time, so either they stand behind their previous decisions or acknowledge they authorized potentially unsafe, ineffective, "risky" medical treatments for your child in the past. Then again, they're not always so sharp or quick on the uptake, so you might just make that point in plain language for them :)

 

I'm just resurfacing online-- we were traveling, ds got a stomach bug while we were away so is flaring some now and we're currently working out his upcoming treatments: T&A and IVIG (at least in his case the IVIG is needed for his immune deficiency and he's already met the criteria outlined in our plan for that). Never dull! I'll try to check in more now that we're settling into something of a groove here, so fire away if you have questions or need more info.

 

Good luck!

 

TH

 

 

 

from Appeal:

 

 

There is evidence available in the medical and scientific literature to satisfy the eligibility criteria and support coverage for the requested treatment. The use of IVIG is considered a safe and effective treatment for children with unremitting PANDAS. It is considered part of the standard of care for the condition by the physicians who treat it. There is evidence both within and beyond the research setting to support its use; and based on its standard use as a treatment, as well as coverage for its use by other national health insurers, its use for this condition is certainly not unproven, experimental, investigational, unsupported, or even unusual.

 

Immunomodulatory therapies, such as IVIG and PEX, are considered proven treatments for Pediatric Neuropsychiatric Disorders Associated with Streptococcus and are covered in the policies of other major health plans, such as United Healthcare, Cigna, and Harvard Pilgrim. As an example, the IVIG coverage policies of United Healthcare and Harvard Pilgrim plans are included with this letter.

 

The medical information database produced and provided to members by Aetna and Kaiser Permanente contains information about PANDAS written by staff pediatrician Michael Sexton, and reviewed by Neurologist Karin Lindholm. The information includes the following statement regarding treatment:

 

“Treatments for children with PANDAS are the same as used for symptoms of OCD or tic disorders. This includes cognitive-behavioral therapy or medicines or a combination of both. Treatment may also include immunotherapy like IVIG or plasma exchange. Immunotherapy is a treatment that uses the body's own immune system to treat an illness. You and your doctor can decide which treatments are best for your child.”

 

A paper published in Clinical Practice and Epidemiology in Mental Health, another peer reviewed journal, “What Every Psychiatrist Should Know About PANDAS: A Review” (enclosed) notes that immunomodulatory therapies, IVIG and PEX, are effective and provide lasting benefit to patients with severe, unremitting PANDAS symptoms.

 

 

The American Academy of Allergy, Asthma and Immunology’s 2005 Position Statement on the Appropriate Use of Intravenously Administered Immunoglobulin (IGIV) includes a statement on PANDAS under the category “other uses.” The position statement notes that beyond the abundance of anecdotal evidence supporting the benefit of IVIG, PANDAS had evidence-based support for its use, since a controlled trial demonstrated efficacy in defined PANDAS patients, unlike similar trials for other disorders such as Chronic Fatigue Syndrome and Autism, which did not yield evidence of benefit. While the paper is now more than five years old, and the evidence, clinical use and insurance coverage for the use of IVIG for PANDAS has developed considerably since then, it is still worth noting that as far back as 2005, the AAAAI Work Group Report supported IVIG as evidence-backed, effective treatment for patients with PANDAS.

 

 

In making the benefit determination for our child, XXXX did not reference a well-documented, widely-cited 1999 study, published in The Lancet, documenting the results of a randomized controlled trial of Plasma Exchange and IVIG in patients with PANDAS by Dr Susan Swedo, of the National Institute of Mental Health, whose research first discovered PANDAS and who has been its lead researcher and expert since that time (study included with this letter). The study showed that use of Plasma Exchange (PEX) and IVIG were effective treatment of PANDAS, and showed long-term benefit (with IVIG showing superior results to PEX, and no demonstrated improvement in the placebo group). The Lancet meets the peer-reviewed journal criteria referenced in our policy guidelines.

 

In the article “Evidence-Based Guidelines on the Use of Intravenous Immune Globulin for Hematologic and Neurologic Conditions,” also published in a qualifying peer-reviewed journal, two panels of experts in neurology and hematology convened to consult evidence, evidence-based reviews, and consensus of expert clinical opinion in order to create evidence-based, expert-informed recommendations for the use of IVIG. The authors state, “IVIG is recommended as an option for treatment of patients with PANDAS. Based on consensus by the expert panel, diagnosis of PANDAS requires expert consultation.” The guidelines contained in this article have been established as the standard for IVIG treatment in Canada.

 

The following is from the US National Institute of Mental Health’s PANDAS information page:

 

What about treating PANDAS with plasma exchange or immunoglobulin (IVIG)?

The results of a controlled trial of plasma exchange (also known as plasmapheresis) and immunoglobulin (IVIG) for the treatment of children in the PANDAS subgroup was published in "The Lancet", Vol. 354, October 2, 1999. All of the children participating in the study had clear evidence of a strep. infection as the trigger of their OCD and tics, and all were severely ill at the time of treatment. The study showed that plasma exchange and IVIG were both effective for the treatment of severe, strep. triggered OCD and tics, and that there were persistent benefits of the interventions. However, there were a number of side-effects associated with the treatments, including nausea, vomiting, headaches and dizziness. In addition, there is a risk of infection with any invasive procedure, such as these. Thus, the treatments should be reserved for severely ill patients, and administered by a qualified team of health care professionals. The NIH is not currently conducting any trials with immunomodulatory therapies, and so is not able to offer either of the treatments.

 

 

Our child’s case was severe, as determined by her treating physicians who see children with PANDAS. Our child was unable to function normally and could not maintain her usual activities of daily living. Some of the symptoms she experienced in this period of infection-triggered exacerbation are as follows:

 

 

****Note: after you document the published evidence, you'll want to show how your child's condition aligns with the cases for which IVIG is indicated as outlined in the literature-- to preempt the potential "not medically necessary in your child's case" comeback should the appeal go to round 2***

 

Here's some more on both the "severity of condition" and evidence fronts:

 

As further evidence of the severity of her case, she participated in Dr. Madeleine Cunningham’s University of Oklahoma research study on Cam Kinase II Activation and Antineuronal Antibody Elevation in PANDAS and Sydenham’s Chorea (the same procedures are used by the NIMH for its research on PANDAS and its treatments). Our child’s Cam Kinase II activation at 187 was near the top of the PANDAS/low Sydenham’s Chorea range and her antineuronal antibody levels were significantly elevated (about 4 SD). For more information on the significance of these results see the article included with this letter, Antibody-mediated cell signaling behavior in movement disorders by Cunningham, Kirvan, Snider, Swedo. Journal of Neuroimmunology 2006.

 

In the paper “Infections and Autoimmunity: A Panorama,” published in The Clinical Review of Allergy and Immunology, 2008, it is noted in the section “Post-Streptococcal Syndromes: Rheumatic Fever and PANDAS” that: “PANDAS is related, at least epidemiologically, to group A streptococci infection, and clearance of serum IgG through Plasmapherisis and IVIG reposition has been associated with remarkable improvement of PANDAS.” It is also noted in this paper that “Anti-basal ganglia antibodies are associated with this disease.” As noted above, our daughter’s anti-neuronal antibodies were significantly elevated and her Cam Kinase II activation value was extremely high for PANDAS, as tested by the University of Oklahoma study. This level of Cam Kinase activation and elevated antineuronal antibodies was not found in subjects who had Obsessive Compulsive Disorder (OCD), the “mental condition.” **** note the wording here is b/c that's what our insurance company used in its denial letter

 

Also relevant to our child’s case is the study noted at the end of the NIMH information: “An Open Trial of Plasma Exchange in Childhood Onset Obsessive-compulsive Disorder Without Poststreptococcal Exacerbations.” In this study it was shown that immunomodulatory therapies did not benefit children whose OCD was not the result of an autoimmune/infection-triggered neurological condition. This is an important distinction. Our child has OCD secondary to, or as one of many symptoms of, an autoimmune neurological disorder— not a mental/behavioral health condition. The autoimmune/physical nature of her illness is why the IVIG treatment was so effective for her.

 

a list of citations from our appeal letter:

 

 

Murphy, T. Storch, E. Strawser, M. Selective Serotonin Reuptake Inhibitor-Induced Behavioral Activiation in the PANDAS Subtype. Primary Psychiatry, 2006; 13 (8) 87-89.

 

http://www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htm

 

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126486.htm

 

[21 CFR 312.3(B)] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.3

 

[21 CFR 312.3(B)] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.3

 

Samir S. Shah, MD; Matthew Hall, PhD; Denise M. Goodman, MD, MS; Pamela Feuer, MD; Vidya Sharma, MBBS, MPH; Crayton Fargason, Jr, MD. Off Label Drug Use in Hospitalized Children, ARCH PEDIATR ADOLESC MED. March 2007; Vol. 161.

 

American Academy of Pediatrics Committee on Drugs. Uses of Drugs Not Described in the Package Insert (Off-Label Uses), Pediatrics. July 2002; Vol. 110 No.1

 

American Academy of Pediatrics Committee on Drugs. Uses of Drugs Not Described in the Package Insert (Off-Label Uses), Pediatrics. July 2002; Vol. 110 No.1

 

Sexton, Michael. Lindholm, Karin. Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcus (PANDAS). Healthwise, 2009.

 

Moretti, G. et al. What every psychiatrist should know about PANDAS: a review. Clinical Practice and Epidemiology in Mental Health. May 2008.

 

American Academy of Allergy, Asthma, and Immunology (AAAAI). Work Group Report on the appropriate use of intravenously administered immunoglobulin. 2005.

 

Leitman, Susan F.; Garvey, Marjorie A.; Hamburger, Susan; Feldman, Elad; Leonard, Henrietta L.; Swedo, Susan E.; Perlmutter, Susan J..

Therapeutic plasma exchange and intravenous immunoglobulin for obsessive-compulsive disorder and tic disorders in childhood.

Lancet (0099-5355). 10/2/1999; Vol.354,Iss.9185;p.1153-1158.

 

 

Anderson, D. Brouwers, M. Feasby, T. Hume, H. Robinson, P. Evidence-Based Guidelines on the Use of Intravenous Immune Globulin for Hematologic and Neurologic Conditions. April 2007; Transfus Med Rev S3-8.

 

http://www.nimh.nih.gov/health/publications/pandas/pandas-frequently-asked-questions-about-pediatric-autoimmune-neuropsychiatric-disorders-associated-with-streptococcal-infections.shtml

 

Nicolson et al: An Open Trial of Plasma Exchange in Childhood Onset Obsessive-compulsive Disorder Without Poststreptococcal Exacerbations. J Am Acad Child Adolesc Psychiatry 2000, 39[10]: 1313-1315.

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