Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for cranial orthotic helmet. The Health Plan has denied this request indicating that the requested equipment is not medically necessary for treatment of the enrollees abnormal head shape (plagiocephaly).Findings:  There is scientific evidence demonstrating that the requested equipment is effective in this clinical setting. Positional plagiocephaly and deformational brachycephaly are broad terms used to encompass abnormal head shape due to a wide variety of etiologies. Prenatal causes include resting of the fetal head against a hard surface such as the mothers pelvis or the limb of a sibling in a multiple gestation pregnancy for a prolonged period of time. Postnatal causes are more common and include congenital torticollis, vertebral anomalies, neurologic impairment, or forced sleep position.  Presentation ranges from mild to severe.  The most mild and even moderate cases may respond to mechanical adjustments and exercises.  However, there are some cases that are severe and refractory to repositioning. Although positional head deformity is generally not a life threatening condition, up to 10% of infants may have permanent deformity with subsequent complications. A study evaluated 176 infants treated with repositioning, 159 treated with helmets, and 37 treated first with repositioning followed by helmet therapy when initial treatment failed. The authors compared reductions in diagonal difference (DD) between repositioning and cranial orthotic therapy. They found that orthotic therapy was more effective than repositioning (61% decrease versus 52% decrease in DD), and early orthosis was significantly more effective than later orthosis (65% decrease versus 51% decrease in DD). They concluded that when physical therapy and repositioning fail to treat or prevent plagiocephaly and there is more than 1 cm difference between the two cranial diagonal differences at 6 months, orthotic therapy is effective in correcting such asymmetry. Delays in initiating corrective treatment until later infancy may lead to incomplete or ineffective correction even if orthotic therapy is initiated, so early diagnosis and treatment is essential. Overall, the use of molding helmet therapy is more effective than repositioning, particularly in patients with moderate to severe deformity. Thus, based on the current standard of care, and supported by current literature, a cranial orthosis is indicated for this patient with significant brachycephaly and some degree of plagiocephaly. In sum, the cranial orthotic helmet is medically necessary for treatment of this patients medical condition. Final Result: The reviewer has determined that the requested equipment is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications:  The reviewer is board certified in pediatrics with sub-specialty certification in pediatric critical care and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.