Clinical Policy Title: Cranial orthotic devices

Transcription

1 Clinical Policy Title: Cranial orthotic devices Clinical Policy Number: Effective Date: September 1, 2013 Initial Review Date: February 18, 2013 Most Recent Review Date: September 21, 2017 Next Review Date: August 2018 Policy contains: Cranial orthotic devices. Craniosynostosis. Positional plagiocephaly. Related policies: None. ABOUT THIS POLICY: AmeriHealth Caritas Pennsylvania has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Pennsylvania s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state or plan specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Pennsylvania when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Pennsylvania s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Pennsylvania s clinical policies are reflective of evidence based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Pennsylvania will update its clinical policies as necessary. AmeriHealth Caritas Pennsylvania s clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Pennsylvania considers the use of cranial orthotic devices to be clinically proven and, therefore, medically necessary when the following criteria are met: For infants where treatment is initiated between three and 12 months of age, and where there has been failure of a trial of conservative therapy such as repositioning and physical therapy, lasting two or more months. A cranial orthotic may be required for children under age 18 months in the post operative period after authorized surgery on cranial structures. Cranial orthotics are custom made for the individual child. Symmetry measurements document moderate to severe plagiocephaly, defined using a Cephalic Index (CI) (calculated per the guidelines of the American Academy of Orthotists and Prosthetists (AAOP), 2004), varying more than two standard deviations of the mean for age and sex, specifically: Males 16 days to 6 months, 63.7 to 83.7 (mean 73.7) Males 6 to 12 months, 64.8 to 91.2 (mean 78.0) 1

2 Females 16 days to 6 months, 63.9 to 82.7 (mean 63.9) Females 6 to 12 months, 69.5 to 87.5 (mean 78.5) For infants with an existing device, it may be necessary to accommodate a larger device after head growth. Limitations: Cranial orthotics should not be used in children under the age of three months, in those over the age of 18 months, or those who have not had physical or repositioning therapy over a two month period. All other uses of cranial orthotics are not medically necessary. Alternative covered services: Physician office visits and physical therapy services within covered benefits. Background Positional skull deformities are common, with an estimated incidence range from one in 300 live births to as high as 48 in 100 children at age 12 months. This wide variation reflects variation in the definitional sensitivity of positional skull deformities, or positional plagiocephaly. The condition is thought to arise from asymmetrical pressures on the bony plates of the immature skull. Such pressures may arise in utero (e.g., from breech presentation) or in the first 12 to 18 months of life. A significant increase in the incidence of positional plagiocephaly began in 1992 after the American Academy of Pediatrics (AAP) and the National Institute of Child Health and Human Development initiated the Back to Sleep Campaign, now known as the Safe Sleep program. This program has been associated witha 70 percent reduction (130.3 to 39.4 deaths per 100,000 live births) in sudden infant death syndrome (SIDS) from 1990 to 2015 (CDC, 2017), but has been associated with a large increase in benign positional plagiocephaly. The current incidence of plagiocephaly in infants 7 12 weeks of age was estimated to be 46.6 percent, based on a sample of 440 healthy full term infants (Mawji, 2013). Infants with this condition are generally treated with repositional therapy and/or physical therapy. Other causes of positional plagiocephaly include torticollis or wry neck, also associated with prematurity. The movement to placing infants in the supine position has been linked to the rise in plagiocephaly and craniocynostosis. In a study of 5169 infants, the rise in referrals for the two conditions from to was 390 and 129 percent, respectively. However, treatment for 279 infants with craniocynostosis begins much earlier; average age declined from 12.4 to 5.6 months (Branch, 2015). Positional plagiocephaly is generally considered a benign condition that does not threaten life, health, development, or intellectual capability. Studies show that cranial asymmetry will resolve spontaneously 2

3 with no intervention in 42 percent of cases. One study found that the positional plagiocephaly incidence declined with age after early infancy (16.0 percent at six weeks, 19.7 percent at four months, 6.8 percent at 12 months, and 3.3 percent at 24 months (Cummings, 2011). The use of physical therapy and/or repositioning techniques has further improved final cranial symmetry. Use of cranial orthotics, either a band or helmet, has been recommended by theaap for infants with mild to moderate cranial asymmetry who have had a significant trial of physical therapy and repositioning management for two to three months and have failed to improve. Cranial orthotics are typically used between the ages of four and 12 months but may be used up to age 18 months. There have not been any significant medical complications identified with the use of cranial orthotics. One study documented that of 380 healthy neonates, 23 were diagnosed with plagiocephaly at birth, but only nine of them still had the condition at age seven weeks (van Vimmeren, 2007). The significant diagnosis of craniosynostosis should be differentiated from positional plagiocephaly. Craniosynostosis occurs from lambdoidal or coronal unilateral fusion. This is a much rarer condition, affecting one of every births worldwide (Hoey, 2012).live births. Molding helmets or orthotics are used only in the post operative period for children who have had surgery to correct craniosynostosis. Generally, cranial orthotics are not used for children with fusion of the sutures of the skull. The American Academy of Orthotists and Prosthetists guidelines (AAOP, 2004) make the following recommendations: Cranial molding orthoses should be considered in the management of deformational plagiocephaly. Repositioning techniques and therapy are viable treatments for infants with deformational plagiocephaly. Allied health professionals should be aware of their role in the identification and prevention of deformational plagiocephaly. Allied health care providers should be educated on the indications for referring infants for a cranial molding orthotic. Scientific literature on the natural course of untreated deformational plagiocephaly is lacking. Parents should learn about the potential for head shape deformities in prenatal and postnatal 3

4 information provided at the hospital. A 2011 guideline from the AAP states the importance of the physician differentiating benign skull deformities from craniosynostosis before making decisions on use of cranial orthoses (Laughlin, 2011). Another guideline from the Congress of Neurological Surgeons, which followed a systematic review, determined that use of cranial orthoses achieved optimal results for severe deformities that were treated as early as possible (Tamber, 2016). Another consensus statement includes 54 best practices for diagnosing and managing plagiocephaly (Lin, 2016). Guidelines for differentiating plagiocephaly from craniosynostosis, developed by the National Association of Pediatric Nurse Practitioners, are also available (Looman, 2012). Searches AmeriHealth Caritas Pennsylvania searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality Guideline Clearinghouse and evidence based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on August 11, 2017, using the terms positional plagiocephaly, cranial orthotic devices, and helmet therapy. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings While the methodologic quality of the literature is generally poor, reviews and guidelines concur that orthotic devices provide better correction of deformational skull asymmetries than repositioning or physical therapy alone. Some treatments are relatively simple. The Canadian Paediatrics Society concluded that tummy time of minutes per day, three times a day, was helpful in resolving any asymmetry from birth or infancy (Cummings, 2011). Numerous studies show that cranial orthotic devices are generally effective, including a systematic 4

5 review of 42 studies. However, this review also noted that increased long term effectiveness compared with conservative therapies continue to be controversial (Goh, 2013). Of 543 infants diagnosed with plagiocephaly and treated with repositioning or physical therapy for 4 8 weeks, 25.2 percent transitioned to helmet therapy after the condition did not improve (Lam, 2017). Another report found that 171 Australian infants had a greater diagonal difference reduction after treatment with helmets, compared to those with no treatment (Ho, 2016). In a group of infants with positional plagiocephaly and undergoing helmet therapy, the average asymmetry index plunged from 9.8 to 5.4 percent (Freudlsperger, 2016). Other reports fail to conclude that cranial orthotic devices are more effective than other treatment choices (Hayes, 2014). Several found greater improvement for helmets than for repositioning (Naidoo, 2015 and Steinberg, 2015). Mild complications are common, including adjusting helmets, removal by older children, intolerance by older children, and overheating in hot climates that cause rashes (Freudlsperger, 2015). Another found that infants assigned to helmet therapy showed similar outcomes (change scores) to those assigned the natural course of the positional skull deformation (Van Wijk, 2014). Treatment effectiveness may vary by the age of the infant. In a large scale study of 1,011 Japanese infants with molding helmet therapy, symmetry of the head improved for both severe and mild cases, and benefits were greatest when therapy was started before the age of six months (Aihara, 2014). In a group of 213 patients with positional plagiocephaly, the largest decline occurred in those beginning treatment with helmet therapy while under 24 weeks of age, compared to the week and > 32 week groups (Freudlsperger, 2016). Quality of life increases have been documented; 46 Dutch children with positional plagioceaphaly and undergoing molding therapy had a quality of life rating rise from 3.6 to 7.5 after treatment, along with a 96 percent satisfaction rate (Grovaert, 2008). A survey of 456 parents found a significantly larger (p<.002) proportion whose infant had helmet therapy would choose the same treatment than those who used repositioning therapy (Naidoo, 2014). Policy updates: A total of five guidelines/other and five peer reviewed references were added to this policy in 2017; a total of five guidelines/other and five peer reviewed references were removed. Summary of clinical evidence: Citation Ho (2016) Content, Methods, Recommendations 5

6 Citation Efficacy of helmet therapy vs. no therapy in infants with cranial asymmetry Aihara (2014) Evaluation of helmet therapy in Japan Goh (2013) Orthotic (helmet) therapy in the treatment of plagiocephaly Cincinnati Children s Hospital (2012) Caregiver education to prevent positional plagiocephaly Cincinnati Children s Hospital (2011) Prognosis of infant development with plagiocephaly, torticollis Hayes (2010) Cranial orthotic devices Xia (2008) Nonsurgical treatment of deformational plagiocephaly Content, Methods, Recommendations 171 Australian infants recruited in outpatient clinics with positional plagioceaphaly. Those with helmets had greater reduction in diagonal difference. 1,011 infants with molding therapy. Head symmetry improved for both severe and mild cases. Treatment especially helpful if started before age six months. Systematic review, 42 studies, cranial orthoses effective in treating deformational plagiocephaly. Noted that statistical significance may not square with clinical significance. Consensus is treatment with helmet therapy does improve asymmetry and head circumference. Although earlier treatment at no more than six months of age is preferred, children older than 12 months of age may still benefit. Caregivers of infants should routinely receive information regarding tummy time and infant positioning beginning prior to age two months to decrease the time infants spend in positions other than supine and decrease the incidence of positional plagioceaphaly. Parents wishing to know if their child s development will be affected by head shape should know that shape is not a predictor of developmental delay. Developmental delay in very young infants (< 22 weeks) appears related to sleep position, muscle tone, activity level, male gender, and neck dysfunction. Moderate level of evidence for reduction or elimination of asymmetry when therapy initiated before 12 to 18 months: o Hayes rating B: Infants with positional plagioceaphaly who have not responded adequately to reposition and/or physical therapy or who are unlikely to respond due to age or severity of deformity, when therapy is initiated before months and considered necessary to avoid surgery or complications due to future mandibular or auricular asymmetry. o Hayes D: Lack of evidence for patients with head deformities due to uncorrected cranial synostosis or hydrocephalus and for preventing or correcting neurodevelopmental delay or disability. Studies comparing helmets with head repositioning in otherwise healthy infants with positional plagioceaphaly with/without torticollis, Seven cohort studies (n = 881);

7 Citation Content, Methods, Recommendations Mix/inconsistent prospective and retrospective. Considerable evidence molding therapy may be more effective at reducing skull asymmetry than repositioning, but studies may be biased. References Professional society guidelines/other: American Academy of Orthotists and Prosthetists Third Consensus Conference. Orthotic Management of Deformational Plagiocephaly. Dallas TX: AAOP, April Accessed August 11, Cincinnati Children s Hospital Medical Center. Best evidence statement (BESt). Use of caregiver education to prevent positional plagiocephaly. Cincinnati, OH: Cincinnati Children s Hospital Medical Center; evidence statement best use ofcare giver education to prevent positional plagiocephaly/#section 424. Accessed August 11, Hayes, Inc. Hayes Director pocket summary: Cranial orthotic devices for the treatment of positional cranial deformity. Lansdale PA: Hayes, Inc., July 17, Annual Review July 6, Accessed August 11, Laughlin J, Luersssen TG, Dias MS; Committee on Practice and Ambulatory Medicine, Section on Neurological Surgery. Prevention and management of positional skull deformities in infants. Pediatrics. 2011;128(6): Lin RS, Stevens PM, Wininger M, Castiglione CL. Orthotic Management of Deformational Plagiocephaly: Consensus Clinical Standards of Care. Cleft Palate Craniofac J. 2016;53(4): Looman WS, Flannery AB. Evidence based care of the child with deformational plagiocephaly, Part I: assessment and diagnosis. J Pediatr Health Care. 2012;26(4): Persing J, James H, Swanson J, Kattwinkel J. Prevention and management of positional skull deformities in infants. American Academy of Pediatrics Committee on Practice and Ambulatory Medicine, Section on Plastic Surgery and Section on Neurological Surgery. Pediatrics. 2003;112(1 Pt 1): Tamber MS, Nikas D, Beier A. Congress of Neurological Surgeons Systematic Review and Evidence Based Guideline on the Role of Cranial Molding Orthosis (Helmet) Therapy for Patients With Positional Plagiocephaly. Neurosurgery. 2016;79(5):E U.S. Centers for Disease Control and Prevention (CDC). Sudden unexpected infant death and sudden infant death syndrome. Last reviewed April 17, Accessed 7

8 August 11, Peer reviewed references: Aihara Y, Konatsu K, Darroku H, Kubo O, Hori T, Okada Y. Cranial molding helmet therapy and establishment of practical criteria for management in Asian infant positional head deformity. Childs Nerv Syst. 2014;30(9): Branch LG, Kesty K, Krebs E, Wright L, Leger S, David LR. Deformational plagiocephaly and craniosynostosis: trends in diagnosis and treatment after the back to sleep campaign. J Craniofac Surg. 2015;26(1): Collett BR, Gray KE, Starr JR, Heike CL, Cunningham ML, Speltz ML. Development at age 36 months in children with deformational Plagiocephaly. Pediatrics. 2013;131. Cummings C. Positional Plagiocephaly. Paediatr Child Health. 2011; 16(8): Eberle NA, Stelnicki E, Boland B. Efficacy of conservative and cranial orthotic therapy in over 4000 patients treated for positional plagiocephaly over a five year period. Plast Reconstr Surg. 2015;136(4 Suppl):5 6. Flannery AB, Looman WS, Kemper K. Evidence based care of the child with deformational plagiocephaly, part II: management. J Pediatr Health Care. 2012;26(5): Freudlsperger C, Steinmacher S, Saure D, et al. Impact of severity and therapy onset on helmet therapy in positional plagiocephaly. J Craniomaxillofac Surg. 2016;44(2): Freudlsperger C, Bodem JP, Karqus S, et al. The incidence of complications associated with molding helmet therapy: an avoidable risk in the treatment of positional head deformities. J Craniofac Surg. 2015;26(4):e Goh J, Bauer D, Durham S, et al. Orthotic (helmet) therapy in the treatment of plagiocephaly. Neurosurgical Focus. 2013:35(4):E2. Grovaert B, Michels A, Colla C, van der Hulst R. Molding therapy of positional plagiocephaly: subjective outcome and quality of life. J Craniofac Surg. 2008;19(1): Ho JP, Mallitt KA, Jacobsen E, Reddy R, et al. Use of external orthotic helmet therapy in positional plagiocephaly. J Clin Neurosci. 2016;29: Hoey AW, Carson BS, Dorafshar AH. Craniosynostosis. Eplasty. 2012;12:ic2. 8

9 Lam S, Pan IW, Strickland BA, et al. Factors influencing outcomes of the treatment of positional plagiocephaly in infants: a 7 year experience. J Neurosurg Pedatr. 2017;19(3): Laughlin J, Luerssen TG, Dias MS, et al. Prevention and management of positional skull deformities in infants. Pediatric. 2011:128. Lee MC, Hwang J, Kim Yo, et al. Three dimensional analysis of cranial and facial asymmetry after helmet therapy for positional plagiocephaly. Childs Nerv Syst. 2015;31(7): Majwi A, Vollman AR, Hatfield J, McNeil DA, Sauve R. The incidence of positional plagiocephaly: a cohort study. Pediatrics. 2013;132: Naidoo SD, Cheng AL. Long term satisfaction and parental decision making about treatment of deformational plagiocephaly. J Craniofac Surg. 2014;25(1): Naidoo DS, Skolnick GB, Patel KB, Woo AS, Cheng AL. Long term outcomes in treatment of deformational plagiocephaly and brachycephaly using helmet therapy and repositioning: a longitudinal cohort study. Childs Nerv Syst. 2015;31(9): Paquereau J. Non surgical management of posterior positional Plagiocephaly: orthotics versus repositioning. Ann Phys Rehabil Med. 2013;56(3): Shamji MF, Fric Shamji EC, Merchant P, Vassilyadi M. Cosmetic and cognitive outcomes of positional plagiocephaly treatment. Clin Invest Med. 2012;35(5):E266. Steinberg JP, Rawlani R, Humphries LS, Rawlani V, Vicari FA. Effectiveness of conservative therapy and helmet therapy for positional cranial deformation. Plast Reconstr Surg. 2015;135(3): Van Vimmeren LA, van der Graff Y, Boere Boonekamp MM, L Hoir MP, Helders PJ, Engelbert RH. Risk factors for deformational plagiocephaly at birth and at 7 weeks of age: a prospective cohort study. Pediatrics. 2007;119(2):e Van Wijk RM, van Vlimmeren LA, Groothuis Oudshoorn CGM, et al. Helmet therapy in infants with positional skull deformation: randomised controlled trial. The BMJ. 2014;348:g2741. Wilbrand JF, Seidl M, Wilbrand M, et al. A Prospective Randomized Trial on preventative methods for positional head deformity: physiotherapy versus a positioning pillow. J Pediatr. 2013;162(6): Xia JJ, Kennedy KA, Teichgraeber JF, Wu KQ, Baumgartner JB, Gateno J. Nonsurgical treatment of deformational plagiocephaly: a systematic review. Arch Pediatr Adolesc Med. 2008;162(8): Yoo HS, Rah DK, Kim YO. Outcome analysis of cranial molding therapy in nonsynostotic plagiocephaly. 9

10 Arch Plast Surg. 2012;39(4): CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comment N/A ICD-10 Code Description Comment Q67.3 Plagiocephaly Q75.0 Craniosynostosis Q75.8 Other specified congenital malformations of skull and face bones Q75.9 Congenital malformation of skull and face bones, unspecified Z98.89 Other specified post procedural states HCPCS Level II Code A8002 A8003 S1040 Description Helmet, protective, soft, custom fabricated, includes all components and accessories Helmet, protective, hard, custom fabricated, includes all components and accessories Cranial remolding orthotic, pediatric, rigid, with soft interface material, custom fabricated, includes fitting and adjustment(s) Comment 10