August 31, Appeals Coordinator United Healthcare P.O. Box Atlanta, GA RE: Patient: Employee: ID#: Group#: Group:

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1 August 31, 2001 Appeals Coordinator United Healthcare P.O. Box Atlanta, GA RE: Patient: Employee: ID#: Group#: Group: To Whom It May Concern: We received your denial of coverage from XXXXX via telephone on July 13, Additionally, we are in receipt of your form letter of July 20, 2001 denying coverage for our son s thermoplastic molding helmet intended to treat his skull deformation. This letter states that this helmet is considered cosmetic treatment and that our son has no functional impairment that would be improved by the thermoplastic molding helmet. 1 We are at a loss to understand this decision and we are confident that once you review the specifics of XXXX s case, you will correct this error and do the right thing by paying for his helmet. Our appeal is based on the following considerations: 1. On July 5, 2001, XXXX s physician, Arno Fried, M.D., F.A.C.S., Director of Pediatric Neurosurgery at Hackensack University Medical Center, prescribed the helmet for XXXX and ordered X-rays and a CT scan to rule out craniosynostotis. Dr. Fried s letter of medical necessity explains that the helmet is necessary to correct XXXX s bilateral occipital plagiocephaly and that XXXX has torticollis, gross and fine motor delays and sensory processing issues. This is Dr. Fried s second letter to you after you requested more information. Dr. Fried also writes that XXXX needs to get this helmet soon to ensure the best possible outcome. 2 Copies of the reports from XXXX s CT scan and X-rays are attached. 3 At the time of the studies, the entire back of XXXX s head was flat, with the shape being like a trapezoid when viewed from above. There was significant bossing of his forehead with some facial asymmetry. This is typical in brachycephaly. 2. We pursued a consultation with Dr. Fried after having XXXX examined on June 20, 2001 by Dr. Scott Bello, a developmental specialist affiliated with Albany Children s

2 Medical Center in Albany, NY and a noted expert on sensory processing deficits in children. XXXX was 38 weeks old at the time of the examination. Dr. Bello reports that XXXX has hypotonia associated with a gross and fine motor delay, at about 26 to 28 weeks. Further, he refers to XXXX s significantly flat occiput and recommends that we get a second opinion from a pediatric orofacial surgeon, regarding the flattening of his occiput and the need for any intervention at this time XXXXXXX, a registered physical therapist (NYS State License #XXXXX) has been treating XXXX for his torticollis and subsequent motor delays since March Additionally, she has provided us with instructions and guidance on stretching XXXX and repositioning him in an effort to help the torticollis and reduce the pressure on his occiput. We have been extremely diligent in pursuing Ms. XXXX s stretching and repositioning exercises. However, since XXXX has a significant delay in his motor skills, he is not able to reposition himself and his sensory issues made him very resistant to our efforts to reposition him. Attached is a letter from Ms. XXXX detailing our son s history and course of treatment. She states that XXXX s occiput has become severely flattened in the rear. 5 Ms. XXXX has told us during the course of XXXX s treatment, that XXXX has the flattest head she has ever seen in her professional career of over 15 years. 4. 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 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 PHYCHOLOGICAL 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 are performed to IMPROVE FUNCTION. 6 The thermoplastic molding helmet prescribed by Dr. Fried is an FDA approved device. The FDA has also said that this condition is a functional and not cosmetic problem. We assume that the physician reviewing this appeal for United Healthcare is a member of the AMA and would not recommend action contrary to AMA standards. 5. There is ample evidence to support long-term physical effects due to untreated deformational plagiocephaly. At the 38 th annual AOA conference, B.F. Degenhardt, D.O., et al. presented findings regarding the relationship of head shape to otitis media. They observed that those children who had plagiocephaly had an increased risk of middle ear infections. 7 Additionally, non-treated positional plagiocephaly has been linked to migraine headaches, difficulty chewing, TMJ and respiratory and vision problems. R.I. Miller and S.K. Clarren, in a paper published in the journal 2

3 Pediatrics, examined links between developmental delay and deformational plagiocephaly and concluded that infants with deformational plagiocephaly comprise a high-risk group for developmental difficulties presenting as subtle problems of cerebral dysfunction during the school-age years. 8 John Persing, M.D., chief of Plastic Surgery at Yale University medical Center, says that a flat head can single out a child for unwanted problems later on that could be due to physical distortions in the face as well as the skull. That s because when you have a flattening in the back of the skull, it often has facial effects not only in the cheekbones but in the jaw. If there s enough of a distortion, kids can pick up on that and, particularly around 5 or 6 years of age, it can be a real problem for children in terms of being accepted within their intended peer group, in how they socialize and even how they do in school. 9 As parents, we are unwilling to allow such physical, developmental and psychological problems to arise when a non-invasive treatment is available to help prevent and correct them. 6. There are numerous correlating factors shown to influence the development of plagiocephaly. We have found repeated mention of the following precipitating factors (to only name a few) 10 : Restrictive intrauterine environment Poor muscle tone (hypotonia) Torticollis Cervical-vertebral abnormalities Sleeping position As noted earlier, XXXX has a developmental delay, hypotonia and torticollis. Additionally, due to XXXX s delay and sensory issues, he slept on his back well beyond the time when other infants are able to reposition themselves. 7. United Healthcare PPO plan has paid for thermoplastic molding helmets for patients with diagnoses identical to my son. In a recent case, IPRO, the agency that handles external appeals for the NYS Insurance Commissioner, reversed United Healthcare s decision to deny coverage for an FDA approved helmet as treatment for positional plagiocephaly. In this case, the infant had plagiocephaly and torticollis, as does XXXX. UHC turned down the treatment for the same reasons that you gave us: no functional deficit and the band would just be to improve appearance. As we plan to appeal an unfavorable decision externally, the insurance commissioner s finding is important. Referring to the helmet, the reviewer writes: This device is not used for COSMETIC purposes, but rather for RECONSTRUCTION. Cosmetic surgery is defined as surgery used to reshape normal structures of the body to improve a patient s appearance. This patient had a deformity of the skull caused by head position. If left untreated, the ears 3

4 can also move into abnormal positions. This baby s head was not normal. This is clearly not cosmetic treatment and should be considered a covered benefit. Please see Neurosurgery Focus 9 (3), May This device is the preferred method of treating positional plagiocephaly after repositioning and physical therapy have failed. THIS IS THE STANDARD OF CARE FOR THIS DISORDER. Therefore, the decision of UHC to deny coverage for a dynamic orthotic cranioplasty band should be reversed. 11 Because our doctor recommended this treatment (and emphasized that we should begin quickly in order to preserve the chance for the best outcome) and despite United Healthcare s initial refusal to cover the cost of XXXX s thermoplastic molding helmet, we have proceeded with the prescribed treatment at significant financial hardship to ourselves. Our options, as we saw them, were as follows: a. No treatment. Given the fact that XXXX already has an uphill struggle ahead of him due to his torticollis, gross and fine motor delays and sensory processing issues, we thought it would be entirely foolish and unacceptable to further complicate his life by exposing him to well-documented psychological, physical and developmental problems due to his plagiocephaly. No one can be certain that some of XXXX s current delays are not due at least in part to his severely flattened head. Further, as XXXX was almost 11 months old, we did not have the luxury of waiting to see if his condition would worsen to the point where UHC would deem the helmet medically necessary or to postpone treatment while your decision was on appeal, as the optimal time to begin helmet therapy is before one year of age. b. Surgical Intervention. While surgery was not immediately deemed necessary, had XXXX s condition continued to worsen, it may well have been required. The cost of surgery could easily exceed twenty times the cost of the Hanger helmet. This helmet is a functional orthotic. Almost all carriers have underwriting for a functional orthotic because the replacement treatment is usually as effective at a fraction of the cost. Risks due to surgery are obvious and we had no desire to put our son through a great deal of pain and suffering when a less expensive, equally effective, non-invasive option existed. c. FDA approved Thermoplastic Molding Helmet from JE Hanger, 317 E. 34 th St, NYC. This non-invasive, relatively inexpensive, pain free procedure was by far the best option. This helmet is identical to the STARband by Orthomerica. At a price of $ , it costs less than half of another FDA approved device, the Dynamic Orthotic Cranioplasty Band by Cranial Technologies and works just as well. Given that we diligently performed physical therapy and repositioning without correction for over 5 months, the helmet was the next logical step. Thank you for your time regarding this matter. 4

5 Sincerely, XXXXXXXX XXXXXXXXX Enclosures Cc: Arno Fried, M.D., Hackensack University Medical Center Robert Brown, JE Hanger, Manhattan Commissioner of Insurance, State of New York 1 HARRINGTON, BARBARA,RN, LETTER: PREDETERMINATION, UNITED HEALTHCARE,JULY 20, FRIED, ARNO,MD, 2 ND LETTER OF MEDICAL NECESSITY, JULY 27, CT SCAN AND X-RAY REPORTS, HACKENSACK UNIVERSITY MEDICAL CENTER, JULY 12, BELLO,SCOTT,MD, REPORT ON RESULTS OF XXXXX S DEVELOPMENTAL EVALUATION, JULY 20, PHYSICAL THERAPIST., LETTER DETAILING XXXX S DELAYS, COURSE OF TREATMENT AND HEAD DESCRIPTION, JULY 28, 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 PHYCHIATRY AMERICAN COLLEGE OF SURGEONS AMERICAN PEDIATRIC SURGICAL ASSOCIATION AMERICAN SOCIETY FOR SURGERY OF THE HAND 7 DEGENHARDT,B.F.,M.D., CRANIAL DYSFUNCTION IN OTITIS MEDIA, 38 TH ANNUAL CONFERENCE ABSTRACTS, MILLER,R.I.,M.D., AND CLARREN,S.K.,M.D., LONG-TERM DEVELOPMENTAL OUTCOMES IN PATIENTS WITH DEFORMATIONAL PLAGIOCEPHALY,PEDIATRICS, Vol. 105, No.2, 2/00, p MELVILLE,NANCY,BABY MOLDS:SHAPE OF THEIR FUTURE STARTS WITH THEIR HEADS, Health Scout News, August 19, GRAHAM,J,CSMC PEDIATRICS/MEDICAL GENETICS:MANAGEMENT OF PLAGIOCEPHALY AND TORTICOLLIS, AHMANSAN PEDIATRIC CENTER/CEDARS SINAI MEDICAL CENTER IAQUINTA, FRANK, M.D., IPRO FOR NEW YORK STATE INSURANCE DEPARTMENT, LETTER TO ANG DONG, 6/26/01. 5