RE: CHILD S NAME DOB: XXXXXXX Denial of DOC Band coverage XXXXXXXXX Care First Blue Cross Blue Shield Contract #: XXXXXX Group #: XXXXXXXXXXXXXX

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1 YOUR ADDRESS Oct. 9, 2002 Care First Blue Cross Blue Shield Attention: Appeals/Supervisor Control Plan Claims Unit P.O. Box 1739 Cumberland, Maryland RE: CHILD S NAME DOB: XXXXXXX Denial of DOC Band coverage XXXXXXXXX Care First Blue Cross Blue Shield Contract #: XXXXXX Group #: XXXXXXXXXXXXXX Dear Sir or Madam: I was very disappointed, but not surprised, to receive your company s denial letter for XXXXXXXXXXXX medically necessary and appropriate Dynamic Orthotic Crainoplasty (DOC) treatment for his plagiocephally (Attachment #1). In my opinion, this decision was not made in good faith, but was rather arbitrary and capricious. I would therefore like to appeal your denial. Being involved in support groups with parents in Maryland and across the country, a disturbing pattern of behavior on the part of Blue Cross Blue Shield has become apparent. The pattern for Blue Cross Blue Shield appears to be first denying coverage for a variety of reasons ranging from it not being medically necessary to it being experimental or even cosmetic. Then after a time-consuming and frustrating appeals process, Blue Cross Blue Shield reverses the decision and then COVERS THE MEDICAL EXPENSE COMPLETELY. I am aware that Blue Cross Blue Shield of Maryland and other divisions of Blue Cross in California, New York, Florida, and Texas, to name the largest, have covered DOC Band treatment. I am in constant contact with XXXXXXXXXXXXXXX. They have the same insurance that I do and their child had DOC band treatment covered by Blue Cross Blue Shield of Maryland. Their DOC Band treatment was covered under durable medical equipment, which is what my DOC Band treatment was submitted under. This practice seems unfair. I am requesting the same standard of care for my son. XXXXXXX s diagnosis, photographs of XXXXXXXX s abnormal head shape, published research journals & other articles, and a copy of your denial letter have been attached for your reference. I challenge your denial based on the following proof: 1) The DOC Band is Medically Necessary 1

2 XXXXXX s primary care physician, Dr. XXXXXXXX (a Doctor in good standing with the American Medical Association,) has been concerned about XXXXXXXX s head shape from birth. I tried various re-positioning techniques, commercial positioning pillows, and environmental changes only to see little change in my son s disfigurement. At XXXXX s four month appointment on June 20 th, 2002, Dr. XXXXXX referred us to Dr. XXXXXX at Inova Fairfax Hospital for Children s Craniofacial Program on July 11 th, Dr. XXXXXXXXX s partner, Dr. XXXXXX, examined my son. Documentation from that day illustrates that XXXXXX was diagnosed with severe right plagiocephaly with ipsilateral ear anterior to the other ear. Frontal bossing is present. (Attachment #2). Guidelines were established at the 1997 Craniosynostosis and Skull Molding Symposium as to the best method for the treatment of plagiocephally. To summarize: if repositioning is unsuccessful orthotic mangement should be considered as the next logical alternative (Ripley, C. et al 1994). 2) Risk of Non-Treatment/Cost-effectiveness of DOC Band Treatment/Blue Cross Blue Shield of Maryland has paid for DOC Band Treatment in the Past Dr. XXXXXXX and Dr. XXXXXXX, two physicians in good standing with the American Medical Association, have both outlined the risks of non-treatment for my son. (Attachments #2 and #6) There is extensive evidence dating back decades that this condition will NOT correct on its own. As stated in the article by Littlefield, et al., (1998) regarding helmet therapy, the earlier an infant presents for treatment, the greater is the likelihood of catching periods of rapid brain growth, resulting in a significant increase in the correction achieved. The optimum age at which an infant should enter treatment is between 3 and 4 months. A delay in entrance not only reduces the effectiveness of treatment, but may also lead to an increase in severity of the condition to be treated. Our clinical observations support the work of Marsh and Vannier (1985) who documented the untreated condition does not correct on its own, and Danby (1962), who documented that the asymmetry associated with plagiocephally, if left untreated, is retained into adulthood. Uncorrected plagiocephally has been linked to respiratory and vision problems, migraine headaches, difficulty chewing, TMJ syndrome, as well as severe psychological consequences. Additionally, the American Whole Health Library notes that, as the number of cranial strain patterns increased, so did incidence of middle ear infection (Anon, 2001). All these factors can lead to an increase in need for medical treatment and hospitalization in the long run. As noted by Dr. Deidre Marshall (1997), of Miami Children s Hospital, Insurance companies must realize that requests for helmet therapy in children in the long run, will be much more cost effective than denying a helmet and then having to fund a major intracranial surgical procedure. 2

3 Helmet Therapy has been documented to effectively replace surgery for correction of deformational plagiocephaly at a FRACTION OF THE COST. Additionally, most insurance carriers have, in their underwriting, coverage for functional orthotics and approximately 95% of all insurance carriers approve and cover the cost of the DOC Band Treatment. Through extensive research, we have found that the following partial list of a few of the insurance carriers that have approved and paid for the DOC Band Treatment: Kaiser, Unicare, Texas Medicade, Blue Cross Blue Shield of MD, AZ and TX and CA, Cigna, American Community, State AHCCS of Arizona, Humana, Aetna, Health Partners Plan, Intergroup, American Family Insurance Group, Corporate Health Administrators, Champus and Partners Health Plan, and Gem Insurance, Anthem Blue of Indiana, Tri Care, Prudential, First Health, Motorola, FHP, EDS, and Principal. It is our belief that since Blue Cross Blue Shield of Maryland has paid for DOC Band treatment for others in the past, our claim should not be denied. 3) The DOC Band is THE Proven and Standard Medical Treatment for Plagiocephally/It is NEITHER COSMETIC NOR EXPERIMENTAL XXXXXX began wearing the DOC Band helmet on August 12 th, Cranial Technologies, Inc is the leading provider of medical devices used in the treatment of plagiocephally in infants. Founded in 1986, they are the only company in the world exclusively dedicated to the treatment of infants with plagiocephally. The Dynamic Orthotic Cranioplasty (DOC) Band was the FIRST device to have gone through the extensive process and been approved by the FDA in The DOC Band holds a Class II rating. According to the FDA: (1) The device is assigned the generic name cranial orthosis, and it its identified as a device intended for use on infants 3 to18 months of age with moderate plagiocephally. (2) In order to receive FDA approval for the DOC Band as a Class II Device, sufficient research and evidence had to be shown on the DOC band s effectiveness (Attachment #5). Attachment #6 is a letter dated April 11,2000 from Michael Lang, Compliance Officer with the Department of Health and Human Services. Michael Lang states FDA does not consider Dynamic Orthotic Cranioplasty DOC Band to be an investigational device, as long as it is being marketed with the same design and indications for use that were documented in its premarket notification. Also, guidelines were established at the 1997 Craniosynostosis and Skull Molding Symposium as to the best method for the treatment of plagiocephaly. To summarize, If repositioning is unsuccessful, or if the initial deformity is too severe, or if the child is too old for reposition to be effective, orthotic management should be considered as the next logical alternative. Furthermore, Neurosurgery Focus 9 (3) May 2000, says that This device [DOC Band] is the preferred method of treating positional plagiocephaly [ ] This is the STANDARD CARE for treatment of this disorder. This clearly proves that the DOC Band is a proven and standard treatment for a medical condition. According to the American Medical Association s Resolution 119 on Coverage of Children s Deformation, Disfigurement and Congenital Defects, the AMA is aware of insurance companies and HMO s denying benefits for treatments of craniofacial 3

4 deformities, disfigurements and congenital defects because the companies claim these problems are non-functional and thus considered cosmetic in nature and therefore are a non-covered disorder. This resolution plainly states that children who do not have birth defects and facial anomalies repaired face long term physical and psychological injuries AMA policy goes on to state Cosmetic surgery (therapy) is performed to reshape Normal structures of the body in order to improve the patient s appearance and self-esteem. Reconstructive surgeries (therapies) are performed on abnormal structures of the body, caused by congenital defects, developmental deformities and are performed to Improve Function. (Attachment #3) In summary, I have provided you with ample medical research materials that demonstrate that the DOC Band was medically necessary for XXXXXXXXX; prescribed by two doctors who are in good standing with the Physicians Review Board; is accepted as valid treatment by the medical community and in the long run is cost effective in comparison to health problems and surgical alternatives. It is also supported and recommended by the AMA and FDA for treatment of plagiocephally. I am sure that whomever at Blue Cross Blue Shield reviewed this case (and the ample evidence that was submitted along with it) is a member in good standing of the AMA, and surely you do not want to contradict the current medical establishment by denying XXXXX s DOC Band treatment. I am requesting retroactive coverage for the DOC Band therapy and reimbursement from Care First Blue Cross Blue Shield for the amount of $ The total cost of the DOC Band treatment therapy charge was $ Again, I am aware that other divisions of Blue Cross throughout the United States have covered DOC Band treatment and I am personally aware of other families such as XXXXXXXXXX with Blue Cross Blue Shield of Maryland who have had the DOC Band treatment covered, and I am requesting the same standard of care for my son XXXXXXX. Thank you for your attention, XXXXXXX, as parent and next friend of XXXXXXXX, a minor CC: The Honorable Chris Van Hollen, Congressman, District 8 Kevin Simpson, Office of the Attorney General, Director of Consumer Protection The Honorable Steven Larson, Insurance Commissioner, Maryland Insurance Administration Unfair Claims Settlement Practices Division Doctor XXXXX, M.D. F.A.A.P. Doctor XXXXX, M.D., D.D.A. Ms. Sandy Elkridge, Cranial Technologies 4

5 Attachments 1. Notice: Denial of Insurance Benefits, Care First Blue Cross Blue Shield of Maryland, September 13 th, XXXXXXXX, Documented Medical Letter of Necessity for XXXXX 3. Department of Health and Human Services Food and Drug Administration, Classification of Cranial Orthosis, Final Rule Action. July 30, Lang, Michael, Letter: Dynamic Orthotic Cranioplasty Not Investigational, Food and Drug Administration, April 11, Photographs of XXXXX s head shape 6. XXXXX, MD, FAAP, Primary Care Physician Letter of Medical Necessity for XXXXXXX References AMA House of Delegates, Resolution 119 (I-97), Subject: Coverage of Children s Deformities, Disfigurement, and Congenital Defects, Introduced by: American Society of Plastic and Reconstructive Surgeons American Society of Maxillofacial Surgeons American Association of Plastic Surgeons American Academy of Child and Adolescent Psychiatry American College of Surgeons American Pediatric Surgical Association American Society for Surgery of the Hand Anon., Cranial Dysfunction in Otitis Media, Whole Health Library/Osteopathy, American Whole Health, Inc. August 12, Kelly, K. et al, Cranial Growth Unrestricted During Treatment of Deformational Plagiocephally, Pediatric Neurosurgery, 1999; 30: Kelly, K., et al, Importance of Early recognition and treatment of Deformational Plagiocephally with Orthotic Cranioplasty, Cleft Palate-Craniofacial Journal, 1999:36: Littlefield, T., et al., Treatment of Craniofacial Asymmetry with Dynamic Orthotic Cranioplasty, The Journal of Craniofacial Surgery, 1998; 9: Marshall, Deidra MD et al, Abnormal Head Shape in Infants, International Pediatrics, The Journal of Miami Children s Hospital, 1997; 12: Ripley, C., et al, Treatment if Positional Plagiocephally with Dynamic Orthotic Cranioplasty, The Journal of Craniofacial Surgery, 1994; 5:

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