Neurofeedback for CLINICAL DISORDER Preemptive Letter: In-Network

Health Plan ADDRESS

Re: Request for Authorization for EEG Biofeedback/Neurofeedback to Treat ADHD

Dear Health Plan Authorization Dept:

I am an in-network provider for Health Plan and am starting to treat a new patient diagnosed with ADHD by using neurofeedback (NFB). NFB is a safe and effective treatment that improves the core symptoms for patients diagnosed with ADHD. The patient is covered by Health Plan, and from past experience, Health Plan has denied coverage when I have billed for NFB to treat ADHD. [Alternatively: The patient is covered by Health Plan, and I see from your website that you do not provide reimbursement coverage for NFB to treat ADHD.]

Health Plan’s denial of coverage for NFB ignores the recent meta-analysis by Arns et al. (2009) of ten well-controlled studies combined with an additional five prospective pre/post design studies. This meta-analysis concluded that “neurofeedback treatment for ADHD can be considered “Efficacious and Specific” (Level 5) with a large effect size for inattention and impulsivity and a medium effective size for hyperactivity” [p. 180]. NFB’s research basis as a treatment for ADHD and learning disabilities continues to grow with over 100 peer-reviewed journal articles published to date (Hammond, 2010).

Health Plan’s denial of coverage also ignores the findings from the MTA follow-up results, the largest ever treatment effectiveness study for ADHD. This multi-centered NIMH-funded study compared systematic medication management (SMM), multi-component behavior therapy (BT), combined SMM/BT, and usual community care (CC) groups to evaluate their effectiveness in treating ADHD [Jensen et al., 2007; Molina et al., 2009]. Despite the initial superiority of SMM and combined SMM/BT treatments, these follow-up analyses found that after 2, 6, and 8 years the four treatment groups did not differ on any outcome measure. Most discouragingly, the researchers report that “the MTA participants fared worse than the local normative comparison group on 91% of the variables tested.” These researchers conclude by stating that “Innovative treatment approaches targeting specific areas of adolescent impairment are needed” [Molina et al., 2009, p. 484]. NFB is one such ‘innovative treatment’ with proven effectiveness targeting the specific areas of impairment that are essential to the diagnosis of ADHD: 1) inattention, 2) impulsivity, and 3) hyperactivity.

I request coverage for this new ADHD patient, and all of my future ADHD patients, in the light of the findings from the Arns et al. meta-analysis, the discouraging follow-up findings from the MTA study demonstrating a lack of sustained benefit from the ‘gold standard’ ADHD Page 2 of 7 treatments Health Plan commonly covers, and this patient’s clinical presentation and treatment history. Furthermore, Health Plan’s blanket denial of NFB for ADHD patients may be a violation of the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (“the Parity Act”) by applying treatment limitations that are more restrictive than those applied to Health Plans medical and surgical benefits. For example, while NFB has multiple randomized controlled trials (RCTs) validating its efficacy in treating ADHD as evidenced in the Arns et al. meta-analysis, there are numerous published articles documenting that many commonly reimbursed medical and surgical treatments have a much lower level of scientific evidence than neurofeedback. For example, a recent analysis of 2,711 practice recommendations in cardiology found that only 11% were based on evidence from more than one RCT while 48% were based simply on expert opinion, case studies, or standards-of-care (Pierluigi et al., 2009). Similarly, a 2011 analysis of the levels of evidence behind the Infectious Diseases Society of America’s practice guidelines found that only 14% were based on top tier level I evidence supported by RCTs, whereas more than half (55%) were supported only by expert opinion (Lee & Vielemeyer, 2011).

As you may know, applying a higher level of scientific evidence to the use of NFB to treat ADHD than that applied to many commonly reimbursed medical procedures as suggested by the cardiology and infectious disease guidelines is a violation of the Parity Act. The Parity Act states that: “The treatment limitations applicable to such mental health or substance use disorder benefits are no more restrictive than the predominant treatment limitations applied to substantially all medical and surgical benefits covered by the plan (or coverage) and there are no separate treatment limitations that are applicable only with respect to mental health or substance use disorder benefits.”

By not paying for NFB which has a greater level of scientific evidence supporting it while paying for many medical/surgical treatments with less evidence, I believe that Health Plan is in violation of the Parity Act.

Section 2.4 of the Parity Act states: “The reason for any denial under the plan (or coverage) of reimbursement or payment for services with respect to mental health or substance use disorder benefits in the case of any participant or beneficiary shall, on request or as otherwise required, be made available by the plan administrator (or the health insurance issuer offering such coverage) to the participant or beneficiary in accordance with regulations.“ And:

“The criteria for medical necessity determinations made under the plan with respect to mental health or substance use disorder benefits (or the health insurance coverage offered in connection with the plan with respect to such benefits) shall be made available by the plan administrator (or the health insurance issuer offering such coverage) in accordance with regulations to any current or potential participant, beneficiary, or contracting provider upon request.”

Furthermore, as made clear in the FAQ’s issued by the Federal regulatory agencies overseeing the Parity Act’s implementation, “documents with information on the medical necessity criteria for both medical/surgical benefits and mental health/substance use disorder benefits are plan Page 3 of 7 documents, and copies of plan documents must be furnished within 30 days of request” (e.g., see http://www.dol.gov/ebsa/faqs/faq-aca5.html). These FAQ’s also make clear that as an in- network provider, these documents “must be made available by the plan administrator or health insurance issuer to any current or potential participant, beneficiary, or contracting provider upon request.”

In accordance with the aforementioned section of the Parity Act and Regulatory FAQ’s, I request the following information be sent to me within 30 days to enable me to evaluate Health Plan’s compliance with the Parity Act:

1. The specific criteria (processes, strategies, evidentiary standards, or other factors) that Health Plan used to deny coverage of NFB including the technology review that Health Plan has done on NFB as well as the policies and criteria that you use to determine whether or not any Mental Health or Substance Use Disorder treatment is experimental; and

2. In that the Parity Act requires that a treatment limitation applied to Mental Health or Substance Use Disorder benefits cannot be more restrictive than what is applied to substantially all medical/surgical benefits, I also need a copy of the criteria (processes, strategies, evidentiary standards, or other factors) that Health Plan uses to decide what medical and surgical procedures are reimbursable and the data which demonstrates how and to what degree these policies are used to reimburse medical and surgical spending by Health Plan. For example, does this policy apply these criteria to more than 50 % of all medical/surgical procedures?

Sincerely,

References:

Arns M, Ridder S, Strel, U, et al. Efficacy of neurofeedback treatment in ADHD: the effects on inattention, impulsivity and hyperactivity: a meta-analysis. Clin EEG and Neuroscience. 2009; 40(3):180-189.

Hammond DC. International Society for Neurofeedback and Research Comprehensive Neurofeedback Bibliography. 2010; http://www.isnr.org/CBCog.cfm.

Lee DH, Vielemeyer O. Analysis of overall level of evidence behind Infectious Diseases Society of America practice guidelines. Arch Intern Med. 2011;171(1): 18-22.

Jensen PS, Arnold LE, Swanson JM, Vitiello B, et al. 3-year follow-up of the NIMH MTA study. J Am Acad Child Adolesc Psychiatry. 2007;46(8):989-1002. Page 4 of 7

Molina BS, Hinshaw SP, Swanson JM, et al. The MTA at 8 years: prospective follow-up of children treated for combined-type ADHD in a multisite study. J Am Acad Child Adolesc Psychiatry. 2009;48(5):484-500.

Pierluigi T, Allen JM, Kramer JM, et al. Scientific Evidence Underlying the ACC/AHA Clinical Practice Guidelines. JAMA. 2009;301(8):831-841.

Evidenced Based Medicine (EBM) EEG Biofeedback Randomized Control Studies:

Arns M, de Ridder S, Strehl U, Breteler M, Coenen A. (2009). Efficacy of neurofeedback treatment in ADHD: the effects on inattention, impulsivity and hyperactivity: a meta- analysis.Clin EEG Neurosci. 2009 Jul;40(3):180-189.

Bakhshayesh, A.R., Hänsch, S., Wyschkon, A., Rezai, M.J. and Esser, G. (2011). Neurofeedback in ADHD: a single-blind randomized controlled trial, European Child & Adolescent Psychiatry, DOI: 10.1007/s00787-011-0208-y

Gevensleben H, Holl B, Albrecht B, Schlamp D, Kratz O, Studer P, Rothenberger A, Moll GH, Heinrich H. (2010). Neurofeedback training in children with ADHD: 6-month follow-up of a randomised controlled trial. Eur Child Adolesc Psychiatry., 19(9):715-724.

Gevensleben H, Moll GH, Heinrich H. (2010). Neurofeedback training in children with ADHD: behavioral and neurophysiological effects Z Kinder Jugendpsychiatr Psychother., 38(6):409-419.

Gevensleben H, Holl B, Albrecht B, Schlamp D, Kratz O, Studer P, Wangler S, Rothenberger A, Moll GH, Heinrich H. (2009). Distinct EEG effects related to neurofeedback training in children with ADHD: a randomized controlled trial. Int J Psychophysiol., 74(2):149-157.

Gevensleben H, Holl B, Albrecht B, Vogel C, Schlamp D, Kratz O, Studer P, Rothenberger A, Moll GH, Heinrich H. (2009). Is neurofeedback an efficacious treatment for ADHD? A randomised controlled clinical trial. J Child Psychol Psychiatry, 50(7):780-789.

Hammer, B.U., Colbert, A.P., Brown, K.A. and Ilioi, E. C. (2011). Neurofeedback for Insomnia: A Pilot Study of Z-Score SMR and Individualized Protocols. Appl Psychophysiol Biofeedback, DOI 10.1007/s10484-011-9165-y

Klingberg, T., Fernell, E., Elesen, P., Johnson, M., Gustafsson, P., Dahlstrom, K., Gillberg, C.G., Forssberg, H. & Westerberg, H.L.P. (2005) Computerized Training of Working Memory in Children With ADHD- A Randomized Controlled Trial. Journal of the American Academy of Child & Adolescent Psychiatry, 44(2): 177-186.

Lansbergen MM, van Dongen-Boomsma M, Buitelaar JK, Slaats-Willemse D. (2011). ADHD and EEG -neurofeedback: a double-blind randomized placebo-controlled feasibility study. J Neural Transm. 2011 Feb;118(2):275-284. Page 5 of 7

Wangler S, Gevensleben H, Albrecht B, Studer P, Rothenberger A, Moll GH, Heinrich H. (2010). Neurofeedback in children with ADHD: specific event-related potential findings of a randomized controlled trial. Clin Neurophysiol., 122(5):942-950.

Examples of Evidenced Base Medicine (EBM) EEG Biofeedback Sham Control & Comparative Studies (search the National Library of Medicine Database at: http://www.ncbi.nlm.nih.gov/pubmed

Becerra, J. 2006. Follow-up study of learning-disabled children treated with neurofeedback or placebo. Clin. EEG & Neurosci., 37(3): 198-203.

Egner et al, 2004. The effects of neurofeedback training on the spectral topography of the electroencephalogram. Clin. Neurophysiol., 115(11): 2452-2460.

Fernandez, T., et al, 2007, Changes in EEG current sources induced by neurofeedback in learning disabled children. An exploratory study. Appl. Psychophysiol. Biofeedback, 32(3-4): 169- 183.

Fernandez,T. et al, 2003. EEG and behavioral changes following neurofeedback treatment in learning disabled children. Clin. Electroencephalogr, 34(3): 145-152.

Leins U, Goth G, Hinterberger T, Klinger C, Rumpf N, Strehl U. (2007). Neurofeedback for children with ADHD: a comparison of SCP and Theta/Beta protocols. Appl Psychophysiol Biofeedback. 2007 Jun;32(2):73-88. Epub 2007 Mar 14.

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Thompson L, Thompson M. (1998). Neurofeedback combined with training in metacognitive strategies: effectiveness in students with ADD. Appl Psychophysiol Biofeedback;23:243-263.

Examples of Evidenced Based Medicine (EBM) EG Biofeedback Non- Randomized Group Studies (search the National Library of Medicine Database at: http://www.ncbi.nlm.nih.gov/pubmed/:

Alhambra, M.A, Fowler, T.P, & Alhambra A.A. (1995). EEG biofeedback: A new treatment option for ADD/ADHD. J ournal of Neurotherapy ,1(2), 39-43

Boyd, W.D & Campbell, S.E. (1998) EEG biofeedback in schools: The use of EEG biofeedback to treat ADHD in a school setting. Journal of Neurotherapy, 2(4), 65-71. Page 6 of 7

Cannon, R., Congredo, M., Lubar, J., and Hutchens, T. (2009). Differentiating a network of executive attention: LORETA neurofeedback in anterior cingulate and dorsolateral prefrontal cortices. Int J Neurosci. 119(3):404-441.

Cannon, R., Lubar, J., Gerke, A., Thornton, K., Hutchens, T and McCammon, V. (2006). EEG Spectral-Power and Coherence: LORETA Neurofeedback Training in the Anterior Cingulate Gyrus. J. Neurotherapy, 10(1): 5 – 31.

Collura, T., Guan, J., Tarrent, J., Bailey, J., & Starr, R. (2010). EEG biofeedback case studies using live z-score training and a normative database. Journal of Neurotherapy, 14(1), 22–46.

Collura, T., Thatcher, R., Smith, M. L., Lambos, W., & Stark, C. (2009). EEG biofeedback training using live z-scores and a normative database. Philadelphia: Elsevier.

Collura, T. (2008). Whole head normalization using live Z-scores for connectivity training. Neuroconnections, April 2008, p 12-18.

Collura, T. (2008). Time EEG Z-score training: Realities and prospects. In: Evans, J., Arbanel, L. and Budsynsky, T. Quantitative EEG and Neurofeedback, Academic Press, San Diego, CA.

Congedo M, Lubar JF, Joffe D. (2001). Low-resolution electromagnetic tomography neurofeedback. IEEE Trans Neural Syst Rehabil Eng., 12(4):387-397.

Friel, P.N. (2007). EEG biofeedback in the treatment of attention deficit hyperactivity disorder. Altern Med Rev. 2007 Jun;12(2):146-151.

Fox DJ, Tharp DF, Fox LC. (2005). Neurofeedback: an alternative and efficacious treatment for Attention Deficit Hyperactivity Disorder. Appl Psychophysiol Biofeedback, 30(4):365-373.

Gevensleben H, Moll GH, Heinrich H. (2010). Neurofeedback training in children with ADHD: behavioral and neurophysiological effects. Z Kinder Jugendpsychiatr Psychother., 38(6):409-41

Hirshberg, L.M. (2007). Place of electroencephalograpic biofeedback for attention- deficit/hyperactivity disorder. Expert Rev Neurother. 2007 Apr;7(4):315-319.

Lévesque J, Beauregard M, Mensour B. (2006). Effect of neurofeedback training on the neural substrates of selective attention in children with attention-deficit/hyperactivity disorder: a functional magnetic resonance imaging study. Neurosci Lett., 394(3):216-221.

Lubar JF, Swartwood MO, Swartwood JN, O'Donnell PH. (1995). Evaluation of the effectiveness of EEG neurofeedback training for ADHD in a clinical setting as measured by changes in T.O.V.A. scores, behavioral ratings, and WISC-R performance. Biofeedback Self Regul., 20(1):83-99

Marzullo TC, Miller CR, Kipke DR. (2006). Suitability of the cingulate cortex for neural control. IEEE Trans Neural Syst Rehabil Eng. 2006 Dec;14(4):401-409. Page 7 of 7

Monastra VJ, Lubar JF, Linden M, VanDeusen P, Green G, Wing W, Phillips A, Fenger TN. (1999). Assessing attention deficit hyperactivity disorder via quantitative electroencephalography: an initial validation study. Neuropsychology., 13(3):424-33.

Monastra VJ, Lubar JF, Linden M. (2001). The development of a quantitative electroencephalographic scanning process for attention deficit-hyperactivity disorder: reliability and validity studies. Neuropsychology. 2001 Jan;15(1):136-44.

Monastra VJ, Lynn S, Linden M, Lubar JF, Gruzelier J, LaVaque TJ. (2005). Electroencephalographic biofeedback in the treatment of attention-deficit/hyperactivity disorder. Appl Psychophysiol Biofeedback. 2005 Jun;30(2):95-114.

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Stark, C.R. (2008). Consistent dynamic Z-score patterns observed during Z-score training sessions – Robust among several clients and through time for each client. Neuroconnections, April, 2008.

Swartwood JN, Swartwood MO, Lubar JF, Timmermann DL. (2003). EEG differences in ADHD- combined type during baseline and cognitive tasks. Pediatr Neurol., 28(3):199-204.