Your Address. Date. Cigna Healthcare of South Carolina, Inc. National Appeals Unit 146 Fairchild Street Charleston, SC Attn: Appeals Unit

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1 Your Address Date Cigna Healthcare of South Carolina, Inc. National Appeals Unit 146 Fairchild Street Charleston, SC Attn: Appeals Unit Re: Baby XXXXXX ID #: XXXXXXXX Subject: Request for Expedited Appeal for Reference Code XXXXXXX Dynamic Orthotic Cranioplasty. To Whom It May Concern: We have received the form letter, dated September 13, 2002, denying benefits for a Dynamic Orthotic Cranioplasty (DOC) Band for Baby X XXXX to treat the deformational occipital plagiocephaly he has developed. This letter states that this helmet does not meet the definition of medical necessity. 1 We are at a loss to understand this decision and we are confident that once you review the specifics of Baby XXX s case, you will correct this error and do the right thing by paying for his helmet. We respectfully challenge the above denial and we are requesting an expedited appeal. We would like to take this opportunity to provide you with information on the following: 1. Our son s diagnosis of deformational plagiocephaly and his medical history up to this point. 2. Current standards of care used in treating patients with plagiocephaly. 3. Latest medical research concerning plagiocephaly and Dynamic Orthotic Cranioplasty therapy. Let us begin this appeal by using basic definitions, obtained from Dorland s Medical Dictionary 2 : 1. Ill: Not well; Sick; a disease or disorder. 2. Illness: A condition marked by a pronounced deviation from the NORMAL healthy state; sickness. 3. Sickness: Any condition or episode marked by pronounced deviation from the NORMAL healthy state. 4. Injury: Harm or hurt; a wound or maim, usually applied to damage inflicted on the body by an external force. 5. Deformity: DISTORTION of any part or general disfigurement of the body; malformation. 6. Cosmetic: BEAUTIFYING: tending to PRESERVE, RESTORE, OR CONFER comeliness. 7. Accidental: (As defined by Taber s Cyclopedic Medical Dictionary) Occurring suddenly, unexpectedly, inadvertently, under unforeseen circumstances Deformational/Positional Plagiocephaly: Characterized by an asymmetrical distortion (flattening of one side) of the skull 4 ; An abnormal head shape resulting from positional molding of the cranium 5 ; or quite literally, oblique head 6,19. Background:

2 Baby XXXX is a six month old male infant born on XX/XX/XX. He was the product of a full term pregnancy, however, there were several maternal complications endangering my life and his. Those complications included hyperemesis gravidarum resulting in gaining no more than 6 pounds over my prepregnant weight, gestational diabetes, preterm labor, and pre-eclampsia which was exacerbated in the post partum period by a seizure. Thankfully, it appears that despite all of those problems we were blessed with a healthy little boy. His neonatal period was uneventful until at approximately 1½ months of age we noted that the back of Baby XXXX s head was flattening out on the right side. He also had some bossing or prominence of his right forehead and his right ear seemed out of alignment with the left. It looked to be a little more forward than the left ear. As a former nurse case manager for XXXXXX and XXXX XXXXX I was familiar with the diagnosis of plagiocephaly, the causes, and the treatments. In an effort to avoid having to put Baby XXXX through the trauma of casting and wearing a DOC Band, I immediately began repositioning him on his left side (he preferred the right side and usually kept his head turned to the right). At his 2 month well visit on XX/XX/XX, I mentioned the flattening to his pediatrician, Dr. XXX XXXX. She made the diagnosis of occipital plagiocephaly and instructed us to continue repositioning his head and return in 2 weeks to check the progress. Following this visit we purchased repositioning pillows for Baby XXXX s crib and car seat/swing. We were vigilant about keeping him on his left side and trying to decrease the amount of time he spent in the car seat, bouncy seat, and swing. When we returned to see Dr. XXXXX on XX/XX/XX she saw no noticeable change and since the research indicated the most effective treatment time was between 3-6 months, she went ahead and made the referral to Dr. XX XXXX XXXXX. Dr. XXXX specializes in craniofacial disorders at the University of South Carolina Medical School where he is a faculty member. Baby XXXX s appointment was scheduled for XX/XX/XX and during this time we continued with the repositioning therapy. We saw Dr XXXX as scheduled and after examining Baby XXXX and reviewing his history and photographs which had been taken prior to his first visit with Dr. XXXX, he concurred with Dr. XXXX s diagnosis. He felt the deformity was significant enough to require correction with a DOC Band and referred us to Cranial Technologies in Charlotte, NC. He also gave us some physical therapy exercises to do with Baby XXXX to try to avoid pressure to the affected side of his head (please see the enclosed information from the Sutherland Institute for Plastic Surgery at Kansas University Medical Center). His request for consideration by Cigna for the prescribed services was also sent on XX/XX/XX. Baby XXXX s initial consult with Cranial Technologies was on XX/XX/XX, after they received the letter of medical necessity from Dr. XXXXX s office. At that visit he was noted to have 8 mm of asymmetry. The therapist recommended that we continue with the repositioning therapy and exercises but also felt the DOC band was necessary. They advised us that they too would file a request with Cigna but were reluctant to proceed with casting at that time to avoid forfeiting any benefits (until we received an approval or denial from Cigna). We saw Dr. XXXXX again on XX/XX/XX for Baby XXXX s 4 month checkup at which time she noted no noticeable change of the deformity. While we were waiting for some communication from Cigna we continued repositioning Baby XXXX s head. He actually now prefers his left side and tummy. As a matter of fact, for the past month he always rolls over to his left side when we lay him down. However, despite repositioning him on his side, increasing the amount of tummy time he has, and the physical therapy exercises there has been no noticeable improvement. We have been doing this since he was 1½ months old with last 4½ months under the supervision of Dr. XXXX. Baby XXXX was measured again by one of the therapists at Cranial Technologies on XX/XX/XX and was found to have 7 mm of asymmetry, which the therapis t attributed to the fact that two different people did the measurements. Thus, there was no measurable improvement in the deformation with the 4½ months of repositioning. We are distressed that this information was provided to Cigna in July and we have been waiting for 2 months on a decision. According to the National Committee on Quality Assurance stand 4.1 regarding the timeliness of utilization management: 1. For precertifications of nonurgent care, the organization makes decisions within two working days of obtaining all the necessary information. 2. For precertifications of nonurgent care, the organization notifies practitioners of the decisions within one working day of making the decision.

3 3. For precertification of nonurgent care that results in a denial, the organization gives enrollees and practitioners written or electronic confirmation of the decisions within two working days of making the decision. 7 As stated in our Cigna Members Guide to Benefits under Section III-C. Agreement Provisions regarding concerns or complaints we ll get back to you as soon as possible, but in any case within thirty (30) days. 8 The research on plagiocephaly emphasizes that the sooner an infant is treated with cranial banding the more effective it is, so we are sure you can understand our concern regarding this delay in a decision. Request for Review: We learned from Dr. XXXX and Cranial technologies that the treatment timing is critical. Treatment needed to be started as soon as possible to prevent further distorti on and to use this period of time during rapid brain growth, to correct Baby XXXX s skull s shape. This treatment is not effective on children older than 18 months old. As stated in Dr. XXXXX s letter, his assessment concluded that this was a medical necessity. It is imperative that therapy begin as soon as possible because our son is nearing the optimum age in which this NON-INVASIVE/NON-SURGICAL approach is most effective (3-6 months of age. A delay in the initiation of banding therapy reduces the effectiveness of treatment and may also lead to an increase in the severity of the deformity 5. This condition will not correct on its own. The misconception that the abnormal head shape will self correct if left alone often increases the initial severity which must be treated later. 20 Additionally, if we do not intervene with the use of cranial banding, there could quite possibly be permanent distortion of the head, which may lead to even more prominent facial asymmetry and accompanying ocular disturbances (resulting from actual deformation of the orbit) 6. In a WebMD reference article obtained off the Internet, cranio-facial surgery program restores health of children with severe skull malformations, B. Cramer of Vanderbilt University Medical Center writes, if left untreated, (plagiocephaly) the deformity can have a serious impact on the child s growth because a child s skull is formed almost 95% to it s maximum, by age 2, it is desirable to correct the defects early. The deformity may also cause psychological problems by the time the child is 3-4 years old. 9 Littlefield et al concur with the psychological effects, severe cases can cause severe emotional and body image problems. 19 There is also some evidence that positional plagiocephaly can result in chronic ear infections, which, as I am sure you are aware, may lead to difficulty in hearing and speech. The American Whole Health Library notes that as the number of cranial strain patterns increase, so did incidence of otitis media. These children who had plagiocephaly had an increase incidence of middle ear infections. 10 Additionally, non treated deformational positional plagiocephaly has been linked to respiratory and vision problems, migraine headaches, difficulty chewing, and TMJ Syndrome. 11 Succinctly put, EARLY RECOGNITION AND TREATMENT ARE ESSENTIAL IN OBTAINING OPTIMUM CLINICAL OUTCOME. Cranial banding therapy is VERY EFFECTIVE in the treatment of positional deformational plagiocephaly. Many research articles have reached this significant conclusion. Most research summaries show: 1. Documented statistically significant increase in cranial growth. 2. Reduction of cranial asymmetries. 3. Infants treated with DOC banding exhibit growth trajectories similar to normals. 12 In other words, cranial banding is effective in achieving complete or near complete correction of nonsynostotic plagiocephalic characteristics. 13 Guidelines were established in 1997 s 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 repositioning to be effective (5-6 months) ORTHOTIC MANAGEMENT should be considered as the next logical alternative! 12 Cranial banding, also known as Dynamic Orthotic Cranioplasty (DOC) is classified by the FDA as a functional orthotic device. It has been documented to effectively replace surgery for correction of deformational plagiocephaly at a FRACTION OF THE COST. 5,13,14 Additionally most insurance carriers

4 have, in their underwriting, coverage for functional orthotics and approximately 95% of carriers approve this therapeutic measure. A position paper, endorsed by the Section of Plastic Surgery of the American Academy of Pediatrics, the American Society of Craniofacial Surgeons, and the American Association of Pediatric Neurosurgeons (to name only a few) states that infants with deformational plagiocephaly usually respond well to the use of skull molding caps 15. Dr. Ann Flannery, Department of Surgery/Section of Neurosurgery at the Medical College of Georgia states: Babies who are severely affected can also be placed in a molding helmet or band 16 However, Cedars-Sinai Medical Center, Department of Pediatrics position on the management of plagiocephaly and torticollis states it best: Management for infants who do not make progress with exercise alone, or for infants with moderate to severe plagiocephaly still present at 6 months involves use of a corrective helmet the results have been excellent. 6 As noted by Dr. Deidre Marshall, of the Miami Children s Hospital, Insurance companies and HMO s must realize that prompt authorization of requests for helmet therapy in children requiring them will, in the long run, be much more cost effective than denying or postponing authorization for a helmet and then having to fund a major intracranial surgical procedure. 15 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 denial of benefits for treatment of children s deformities, disfigurements, and congenital defects CLAIMING that these services are NON-FUNCTIONAL and thus considered COSMETIC in nature and therefore declared a non covered disorder or not medically necessary. This resolution, continues, recognizing that CHILDREN WHO DO NOT HAVE BIRTH DEFECTS AND FACIAL ANOMALIES REPAIRED FACE LONG TERM PHYSICAL AND PSYCHOLOGICAL INJURIES the 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) performed on ABNORMAL structures of the body, caused by congenital defects, developmental abnormalities, are performed to IMPROVE FUNCTION. 17 Conclusion: Dr. XXXXX XXXX XXXXX, the plastic surgeon you authorized us to visit, is board certified by the American Board of Plastic Surgery and specializes in craniofacial disorders. In contrast, the coverage was denied by someone specializing in areas other than plastic surgery. There are costly exams that can be done to diagnose this disorder (CT scans, MRI), however, in a critical review of the literature and studies done on plagiocephaly, Dr. Harold Rekate states: As stated in a commentary in Pediatrics and an editorial in Lancet, the best diagnostic test in a case of occipital plagiocephaly is the physical examination. The examination REQUIRES that the physician or nurse practitioner look down at the top of the baby s head. The asymmetry of the ear position and flatness of the occiput are clearly visible by this simple and inexpensive technique that can be done quickly. 18 Based on this we do not understand how a physician who, once again, does not specialize in craniofacial disorders or pediatric neurosurgery and has not examined our son s deformity can accurately and objectively deny this treatment. In fact, according to the American Board of Medical Specialties Dr. Koren is a Family Practice physician. We are confident that this letter, along with the enclosed reference material, clearly proves that cranial banding therapy meets (and in many cases, exceeds) all of the following criteria established by Cigna Healthcare. 1. Meets the basic health need of our son.

5 2. Is consistent with the diagnosis of the condition for which it is required. 3. Is consistent in type, frequency, and duration of treatment with scientifically based guidelines as determined by medical research. 4. Is required for reasons other than the comfort or convenience of our son or his physician. 5. Is rendered in the least intensive setting that is appropriate for our son s care. 6. Is of demonstrated medical value. 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 Cigna Healthcare s initial refusal to cover the cost of Baby XXXXX s thermoplastic molding helmet, we have proceeded with the prescribed treatment at significant financial hardship to ourselves. Based on the information we have reviewed we could not in good conscience risk any more precious time to correct our son s significant plagiocephaly while awaiting final approval from Cigna. Our options as we saw them, were as follows: a. No treatment. We felt it would be entirely foolish and unacceptable to complicate Baby XXXX s life by exposing him to well documented psychological, physical, and developmental proble ms due to his plagiocephaly. Furthermore, as Baby XXXX is now 6 months old, we did not have the luxury of waiting to see if his condition would worsen to the point where Cigna would deem the helmet medically necessary or to postpone treatment while your decision was on appeal, as the optimal time to begin cranial banding therapy is between 3-6 months of age. b. Surgical Intervention. While surgery has not been immediately deemed necessary, had Baby 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 DOC Band. 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, noninvasive option existed. c. FDA approved Dynamic Orthotic Cranioplasty Band from Cranial Technologies. This non-invasive, relatively inexpensive (when compared to option b.), pain free procedure was by far the best option. Given that we diligently performed repositioning and physical therapy exercises without correction for over 4 months, the band was the next logical step. We are aware that Cigna has paid for this therapy in the past for other patients and would request that the same consideration be given to our son. As demonstrated in Bynum vs. Cigna Healthcare of North Carolina, the precedent is there. We certainly believe that in the case of an infant facing significant physical and psychological problems which could be corrected by this simple therapy and meets the criteria for medical necessity established by Cigna, a judge and jury would find in favor of the infant. In summation, without the DOC Band treatment, Baby XXXX may suffer even more severe medical side effects that only can be corrected through expensive surgeries and procedures. We would like to request and expedited appeal on Baby XXXX s behalf. We feel confident that with all the information provided above, Cigna will reconsider the denial and provide coverage for our son. Thank you for your time and consideration of this appeal. Sincerely, XXXXXX X XXXXXXX CC: Palmetto Pediatric and Adolescent Clinic Dr. XXXXXXX University Specialty Clinics, Department of Plastic Surgery - Dr. XXXXXXX Cranial Technologies

6 Collins & Lacy, P.C. - P. Brooks Shealy, Attorney at Law South Carolina Department of Insurance Ernst N. Csiszar, Commisioner State Senator Warren Giese State Representative Eldridge Emory South Carolina Medical Association State Farm Benefits Director Susan Carlile

7 1 Koren, Jim, MD, Letter: Predetermination, Cigna Healthcare of South Carolina, September 13, Dorland s Medical Dictionary. Ingelfinger, F.J. MD, Editor, The Saunders Press, Taber s Cyclopedic Medical Dictionary, 15 th Edition, Thomas, Clayton L. MD, MPH, Editor; F.A. Davis Company Cephalic Disorders Fact Sheet, National Institute of Neurological Disorders and Stroke, National Institute of Health. 5 Littlefield, T. et al, Treatment of Craniofacial Asymmetry with Dynamic Orthotic Cranioplasty, The Journal of Craniofacial Surgery, 1998;9: Graham, J. CSMC Pediatrics/Medical Genetics: Management of Plagiocephaly and Torticollis, Ahmansan Pediatric Center/Cedars-Sinai Medical Center, 7 Standards for Utilization Management, National Committee for Quality Assurance, March Cigna Healthcare Guide to Your Benefits. Page 25. January Cramer, B. Craniofacial Surgery Program Restores Health of Children with Severe Skull Malformations, VUMC (Vanderbilt University Medical Center) Reporter, 1991 Mar 1; 2(8): 1,3, WebMD Reference Article Cranial Dysfunction in Otitis Media, WholeHealth Library/Osteopathy, American WholeHealth, Inc Plagiocephaly, ask Dr. Stoll, 12 Kelly, K. et al, Cranial Growth Unrestricted During Treatment of Deformational Plagiocephaly, Pediatric Neurosurgery, 1999, 30: Ripley, CE et al, Treatment of Positional Plagiocephaly with Dynamic Orthotic Cranioplasty, The Journal of Craniofacial Surgery, 1994; 5: DOC: Dynamic Orthotic Cranioplasty, Cranial Technologies, Inc Marshall, Deidra MD et al, Abnormal Head Shape in Infants, International Pediatrics: The Journal of Miami Children s Hospital. 1997, 12: Flannery, Ann, MD, Positional Plagiocephaly, Fact sheet from Medical College of Georgia, Department of Surgery, Section of Neurosurgery, 17 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

8 18 Rekate, Harold L. MD, Occipital Plagiocephaly: A Critical Review of the Literature, Neurosurgical Focus Littlefield, Timothy, MS et al, Diagnosis and Management of Deformational Plagiocephaly, Barrow Neurological Institute Quarterly. 2001, 17(4) Pomatto, JK et al, Etiology of positional plagiocephaly in triplets and treatment using a dynamic orthotic cranioplasty device: Report of three cases, Neurosurgical Focus, February 1997,