Draft Letter to Texas Medicaid

October 9, 2007

Nebraska Department of Health & Human Services Finance & Support Nebraska Medicaid PO Box 95026 Lincoln, Nebraska 68509-5026

Dear Mr. Laughlin,

I am writing to ask for your time to consider revising the current Nebraska Medicaid policy for the coverage and reimbursement of custom cranial remolding orthoses for infants with deformational (positional) plagiocephaly. As described below, I urge you to ensure that families relying on Nebraska Medicaid have meaningful access to therapy with cranial orthoses. The well-established standard of care dictates the treatment of moderate to severe positional plagiocephaly with cranial remolding orthoses when patients are between 3 and 18 months old.

The Food and Drug Administration (FDA) has regulated cranial orthoses as Class II devices since 1998. Currently, the FDA’s regulations classify cranial remolding orthoses as devices intended

…for medical purposes, to apply pressure to prominent regions of an infant’s cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe non-hypostatic positional plagiocephaly. See 21 CFR 882.5970 (Cranial Orthosis).

There are over two dozen companies and organizations that have obtained clearance from the FDA to manufacture these orthoses in the United States. See 510(k) Premarket Notification Database at www.accessdata.fda.gov.

As an orthotics and prosthetics provider, Family Orthotics and Prosthetics, Inc. has always worked collaboratively with Medicare, Medicaid, and third party payers, and we are available to serve as a resource for information regarding the clinical use of orthotics and prosthetics, including cranial remolding orthoses. It is in this collaborative spirit that we provide this summary of the available information regarding the standard of care and the clinical literature involving the treatment of positional plagiocephaly. This information demonstrates that treatment with cranial remolding orthoses is medically necessary for certain infants with deformational plagiocephaly, and this treatment should be covered by Nebraska Medicaid. Below, we elaborate on the following points:

I. The well-established standard of care involves treatment of patients who have moderate or severe positional plagiocephaly with cranial remolding orthoses.

II. The clinical literature strongly supports the treatment of moderate or severe deformational plagiocephaly with cranial remolding orthoses.

III. There are important clinical rationales for treating deformational plagiocephaly.

IV. Health plans have adopted objective standards to define patients requiring treatment for moderate or severe deformational plagiocephaly.

V. The Federal EPSDT Mandate requires the coverage of Cranial Remolding Orthoses when medically appropriate for the treatment of infants with moderate or severe positional plagiocephaly.

* * * * * *

I. The Well-Established Standard of Care Involves Treatment of Patients Who Have Moderate or Severe Positional Plagiocephaly with Cranial Remolding Orthoses

The term “positional plagiocephaly” refers to infants with skull shape deformities who have open cranial sutures that are not fused. Positional plagiocephaly is sometimes referred to as “deformational plagiocephaly” or “non-synostotic plagiocephaly.” The word “non-synostotic” is used to distinguish positional plagiocephaly from craniosynostosis, which refers to infants with premature closure of one or more cranial sutures.

There are a number of national health insurance plans and state Medicaid programs that have promulgated recent coverage policies that provide infants with coverage for the treatment of positional plagiocephaly with cranial remolding orthoses. Some examples of national health insurance plans with explicit coverage policies follow below.

Aetna recognizes cranial remolding orthoses as “medically necessary for moderate to severe positional head deformities associated with premature birth, restrictive intrauterine positioning, cervical abnormalities, birth trauma, torticollis (shortening of the sternocleidomastoid muscle), and sleeping positions in children . . . .” (See Tab 1, Aetna Clinical Policy Bulletin: Cranial Remodeling Bands and Helmets (No. 0379).

Under Aetna’s policy, treatment must begin between 4 to 12 months of age and certain conditions must be met. The policy explains that “[w]hen the deformity is moderate or severe and a trial of repositioning the infant has failed, a pediatric neurologist, neurosurgeon or other appropriate specialist in craniofacial deformities may prescribe a cranial remodeling band to remodel the misshapen head.” Id. Page 3

Similarly, BlueCross BlueShield of Texas and BlueCross BlueShield of Illinois both cover cranial remolding orthoses for the treatment of positional plagiocephaly in infants as a non-surgical treatment for craniofacial abnormalities in children. The treatment must be initiated when the child is between 4 and 18 months of age and must meet certain conditions. (See Tabs 2 and 3, BlueCross BlueShield of Texas Medical Policies: Cranial Remolding Orthosis (CRO) Device (No. DME103.007, eff. July 1, 2005); and BlueCross BlueShield of Illinois Medical Policies: Cranial Remolding Orthosis (CRO) Device (No. DME103.007, eff. July 1, 2005)

The policies of Aetna, BlueCross BlueShield of Texas and BlueCross BlueShield of Illinois are good examples of the clinical criteria commonly used to define medically necessary coverage of treatment with cranial remolding orthoses for infants with head shape deformities. In these and other polices like them, coverage is provided for infants having one of the following two types of head shape deformities:

 Asymmetric Head Shape Deformities: These policies cover asymmetric head shape deformities consisting of right to left (cranial vault) discrepancies of greater than 6 millimeters in any craniofacial anthropometric measurement.

 Proportional Head Shape Deformities: These policies also cover proportional head shape deformities consisting of brachycephaly (a uniform head flattening—central occipital flattening causing a disproportionally wide head with steep vertex height) or dolicocephaly (a long and narrow shape, also called scaphocephaly) confirmed by a cephalic index of two standard deviations above or below the mean. The cephalic index is the relationship between the width of the head divided by the length of the head.(See generally Tabs 1, 2 and 3, the Aetna, BlueCross BlueShield of Texas and BlueCross BlueShield of Illinois policies on cranial remolding orthoses)

Even our own BlueCross BlueShield of Nebraska covers cranial remolding orthoses for the individuals and families its policies support. As stated in the provider’s Medical Policy Manual, “Helmet therapy is scientifically valid for treatment of deformational plagiocephaly.” (See Tab 7, BlueCross BlueShield of Nebraska Medical Policy Manual: Helmet Therapy (No. VII.38, eff. February 1, 1997)

These policies reflect the fact that the well-established standard of care relies on the treatment of moderate and severe positional plagiocephaly with cranial remolding orthoses. This standard of care is illustrated further by the fact that families of children with positional plagiocephaly have sued physicians successfully for failing to treat positional plagiocephaly with cranial remolding orthoses in some states. Similarly, federal courts have required health plans to cover cranial remolding orthoses to treat plagiocephaly under the Federal Employee Retirement Income Security Act (ERISA).1

In addition to the policies described above, numerous state Medicaid programs provide explicit coverage of cranial remolding orthoses, including the following:

1 See Bynum v. Cigna Healthcare of North Carolina, Inc., 287 F.3d 305 (4th Cir. 2002). Page 4

● California’s Medicaid program (Medi-Cal) covers cranial molding helmets for children up to 2 years of age for the treatment of plagiocephaly. (See Tab 4, California Medicaid Orthotic and Prosthetic Appliances Coverage Policy at 9 (revised October 2006)

● The Florida Medicaid program covers custom cranial remolding orthoses when “medically necessary to correct a moderate or severe craniofacial deformity.” (See Tab 5, Florida Medicaid DME and Medical Supply Services Coverage and Limitations Handbook)

● The Indiana Medicaid program covers cranial remolding orthoses for children between 4 and 24 months of age with moderate to severe positional plagiocephaly. (See Tab 6, Indiana Health Coverage Programs Provider Monthly Newsletter (October 2004)

● Kentucky’s Medicaid program covers custom fabricated cranial remolding orthoses, including fitting and adjustment costs. (See Tab 7, Kentucky Medicaid DME Database, Code S1040)

● Mississippi’s Medicaid program covers cranial molding helmets to treat positional plagiocephaly. (See Tab 8, Mississippi Medicaid Provider Policy Manual, § 10.103)

● The New Hampshire Medicaid program covers cranial remolding orthoses. (See Tab 9, New Hampshire Medicaid Bulletin, Vol. XII, Issue IV (March 2006)

● South Carolina covers cranial remolding orthoses under Medicaid, including fitting and adjustments. (See Tab 10, South Carolina Medicaid Program Durable Medical Equipment Provider Manual, § 4)

 The Texas Medicaid program covers cranial remolding orthoses for infants between 3 and 18 months of age. (See Tab 11, Texas Medicaid Bulletin, Vol. 204 (May/June 2007) eff. May 1, 2007)

● West Virginia’s Medicaid program covers custom fabricated cranial remolding orthoses, including fitting and adjustments. (See Tab 12, West Virginia Medicaid HCPCS Codes for Orthotic/Prosthetic Services, Code S1040)

● The Wisconsin Medicaid program covers cranial banding up to 18 months of age. (See Tab 13, Wisconsin Medicaid Coverage Policy 97-B-04-119)

II. The Clinical Literature Strongly Supports the Treatment of Moderate and Severe Positional Plagiocephaly with Cranial Remolding Orthoses

Cranial remolding orthoses have a strong track record of successfully treating moderate and severe positional plagiocephaly. In the United States, treatment of positional plagiocephaly with cranial remolding orthoses is the standard of care, which means that withholding treatment in the context of a double-blinded study would likely subject patients to potential harm. Nonetheless, there are Page 5 numerous published studies in the clinical literature that validate the effectiveness of this treatment, including the studies described below.

In 2006, Plank et al. published results of a study of over 200 infants with deformational (positional) plagiocephaly. The first group used the STARscanner and was treated with the STARband Cranial Remolding Orthosis, while the second group received a repositioning program without orthotic intervention. The results demonstrated that cranial remolding orthoses significantly improved head symmetry. As stated in the article, “symmetry improved significantly more with [cranial remolding orthoses] than without.” (See Tab 14, Plank LH, Giavedoni B, Lombardo JR, Geil MD and Reisner A. Comparison of Infant Head Shape Changes in Deformational Plagiocephaly Following Treatment With a Cranial Remolding Orthosis Using a Noninvasive Laser Shape Digitizer. Journal of Craniofacial Surgery. 2006; 17(6):1084-91.)

In 2005, Graham et al. published a study on the treatment of plagiocephaly based on 298 consecutive infants treated with some combination of repositioning or helmet (cranial remolding orthosis) therapies. The authors found that treatment with a cranial remolding orthosis was more effective than repositioning, and early initiation of treatment with a cranial remolding orthosis was more effective than later initiation. The authors recommended a trial of repositioning, concluding that treatment with cranial remolding orthoses is recommended to correct asymmetry if the cranial diagonal difference persists in excess of 1 cm at six months of age. The authors cautioned that delays in initiating such corrective treatment until later infancy could lead to incomplete or ineffective correction. (See Tab 15, Graham JM Jr., Gomez M, Halberg A, Earl DL, Kreutzman JT Cui J and Guo X. Management of Deformational Plagiocephaly: Repositioning versus Orthotic Therapy. The Journal of Pediatrics. 2005; 146:258-62.)

Graham et al. also evaluated the use of cranial remolding orthoses in the treatment of 193 infants with brachycephaly, a form of proportional head shape deformity. The authors found that cranial remolding orthoses are more effective than repositioning in correcting severe brachycephaly. The authors recommended a trial of repositioning with the subsequent use of cranial remolding orthoses to treat brachycephaly in patients with a cephalic index greater than 90 percent that persists after 5 months of age. (See Tab 16, Graham JM Jr., Kreutzman JT, Earl DL, Halberg A, Samayoa C and Guo X. Deformational Brachycephaly in Supine-Sleeping Infants. The Journal of Pediatrics. 2005; 146:253-57.)

In a study involving over 750 patients, Littlefield et al. documented complete or near complete correction of infants’ head shape asymmetry due to positional plagiocephaly through treatment with custom-fabricated cranial orthoses. (See Tab 17, Littlefield TR, Beals SP, Manwaring KH, Pomatto JK, Joganic EF, Golden KA and Ripley CE. Treatment of Craniofacial Asymmetry with Dynamic Orthotic Cranioplasty. Journal of Craniofacial Surgery. 1998; 9(1):11-17.)

Mulliken et al. conducted a prospective study of 114 infants with deformational (positional) posterior plagiocephaly. The authors found that treatment with a cranial remolding orthoses resulted in better cranial symmetry than patients managed solely with repositioning. The authors concluded that treatment with cranial remolding orthoses is recommended if skull flattening persists after a two- month trial of crib positioning. (See Tab 18, Mulliken JB, Woude DLV, Hansen M, LaBrie RA and Scott RM. Analysis of Posterior Plagiocephaly: Deformational versus Synostotic. Journal of the American Society of Plastic and Reconstructive Surgeons. 1999; 103(2):371-380.) Page 6

Taken in combination, these and other studies published in the clinical literature, serve to highlight the clinical effectiveness of cranial remolding orthoses in treating positional plagiocephaly. In addition, the volume of patients evaluated in these prospective and retrospective studies also highlights that cranial remolding orthoses are an important aspect of the standard of care in the United States followed by physicians treating patients with positional plagiocephaly.

III. There Are Important Clinical Rationales for Treating Positional Plagiocephaly

Although the treatment of positional plagiocephaly may improve patients’ appearance, there are also important clinical rationales for treating positional plagiocephaly. A number of studies have highlighted the association between untreated positional plagiocephaly and adverse (and costly) clinical conditions.

In one study, Kordestani et al. showed that before any intervention, infants with deformational plagiocephaly have significant delays in mental and psychomotor development patterns compared to standardized populations. The 110 infants in the sample were scored on the basis of a mental development index using groupings of “accelerated,” “normal,’ “mild delay” and “severe delay.” Notably, none of the infants with plagiocephaly were found to be “accelerated,” even though an expected distribution would find 16 percent of the sample in the accelerated group. (See Tab 19, Kordestani RK, Patel S, Bard DE, Gurwitch R and Panchal J. Neurodevelopmental Delays in Children with Deformational Plagiocephaly. Plastic and Reconstructive Surgery. 2006; 117:207- 18.)

Panchal et al. reached similar conclusions in a prior study involving infants with plagiocephaly. The investigators found that before any intervention, infants with plagiocephaly without synostosis demonstrate delays in cognitive and psychomotor development. (See Tab 20, Panchal J, Amirsheybani H, Gurwitch R, Cook V, Francel P, Neas B and Levine N. Neurodevelopment in Children with Single-Suture Craniosynostosis and Plagiocephaly without Synostosis. Plastic and Reconstructive Surgery. 2001; 109:1492-98.)

Similarly, another study concluded that children with deformational plagiocephaly should be screened and monitored for developmental delays or deficits. (See Tab 21, Collett B, Breiger D, King D, Cunningham M and Speltz M. Neurodevelopmental Implications of “Deformational” Plagiocephaly. Journal of Developmental and Behavioral Pediatrics. 2005; 26(5):379-89.)

Kane et al. found a correlation between uncorrected plagiocephaly (without synostosis) and mandibular dymorphologies. For subjects with plagiocephaly without synostosis, the authors found that various forms of jaw malformations occurred at a statistically significant rate. Although the authors noted that a certain degree of asymmetry may be normal, “the magnitude of the asymmetry” indicated abnormality in jaw morphology in the subjects suffering from plagiocephaly. (See Tab 22, Kane AA, Lo LJ, Vannier MW and March JL. Mandibular Dysmorphology in Unicoronal Synostosis and Plagiocephaly without Synostosis. Cleft Palate-Craniofacial Journal. 1996; 33(5)418-23.)

In addition, Siatkowski et al. demonstrated that uncorrected plagiocephaly may affect visual field development. A study of 40 infants with deformational posterior plagiocephaly found significantly Page 7 higher occurrences of constriction of one or more hemifields by at least 20 degrees compared to infants without plagiocephaly. (See Tab 23, Siatkowski RM, Fortney AC, Nazir SA, Cannon SL, Panchal J, Francel P, Feuer W and Ahmad W. Visual Field Defects in Deformational Posterior Plagiocephaly. Journal of the American Association for Pediatric Ophthalmology and Strabismus. 2005; 9(3):274-78.)

IV. Medicaid Programs and Health Plans Have Adopted Objective Standards to Define Patients Requiring Treatment for Moderate or Severe Positional Plagiocephaly

Medicaid programs and private health plans have developed objective standards for defining when cranial remolding orthoses are medically necessary. Although there are some variations, these plans use relatively consistent standards for the coverage of cranial remolding orthoses for treatment of positional plagiocephaly. These standards provide the assurance that cranial remolding therapy is only provided when medically necessary and appropriate, and under circumstances in which this treatment is likely to be effective. For instance:

● Plans frequently cover cranial remolding orthoses only for moderate or severe positional plagiocephaly.

● Plans only consider orthotic treatment medically necessary when initiated during a limited age range. Plans typically provide coverage for orthotic treatments begun as early as 3 months of age and extending to treatment begun by 18 months of age. Some plans also limit the end date for coverage.

● Plans generally impose data criteria to establish the extent of the cranial abnormality or asymmetry. For asymmetric head shape deformities, health plans typically provide coverage only if right to left discrepancies are greater than 6 millimeters in one of the common craniofacial anthropometric measurements. For proportional head shape deformities, health plans typically provide coverage only if the cephalic index is at least two standard deviations above or below the mean.

● Health plans typically require the use of more conservative therapy as a pre-condition to coverage of cranial remolding orthoses. This typically consists of a trial of repositioning therapy for two months, unless the patient already has reached the age of six months at which point, progression to treatment with a cranial remolding orthosis is warranted whether or not a repositioning trial has been attempted.

By using objective measures, the review of claims for medical necessity is simplified and health plans can ensure that coverage is focused on patients with moderate and severe cases of positional plagiocephaly. (See generally Tabs 1, 2 and 3, the Aetna, BlueCross BlueShield of Texas and BlueCross BlueShield of Illinois policies on cranial remolding orthoses)

V. The Federal EPSDT Mandate Requires the Coverage of Cranial Remolding Orthoses When Medically Appropriate for the Treatment of Infants with Moderate or Severe Positional Plagiocephaly. Page 8

As you are aware, federal Medicaid law requires that each state Medicaid program provide “early and periodic screening, diagnostic, and treatment services” (EPSDT services) for eligible Medicaid enrollees under 21 years of age. (See 42 U.S.C. §§ 1396d(a)(4)(B) & 1396d(r)(5) It is well established that the EPSDT mandate requires States to cover “every type of health care or service necessary” for corrective or ameliorative purposes that is eligible for federal financial participation (FFP) through the Medicaid program.2 States certainly maintain discretion to set reasonable limits on the amount, duration and scope of EPSDT services, but the Centers for Medicare & Medicaid Services (CMS) has emphasized that States must guarantee that all medically necessary services eligible for FFP are provided.3

As we describe above, there are numerous state Medicaid programs that cover medically necessary cranial orthoses for moderate and severe positional plagiocephaly. These states include but are certainly not limited to, California, Florida, Idaho, Illinois, Indiana, Kentucky, Michigan, Minnesota, Mississippi, New Hampshire, South Carolina, Texas, Utah, West Virginia and Wisconsin. These states, and perhaps others, presumably are receiving FFP for medically necessary cranial orthoses. Furthermore, the fact that these states are doing so suggests that CMS recognizes these therapies as a legitimate form of “medical assistance” under the Medicaid statute. (See 42 U.S.C. § 1396d(a) As a result, the Nebraska Medicaid program has a legal obligation to provide such therapies for EPSDT- eligible children when determined to be medically necessary.

* * * * * *

I am pleased to provide this information on the clinical and legal rationales for Nebraska Medicaid to cover and reimburse for cranial remolding orthoses used in the treatment of infants with moderate and severe positional plagiocephaly. We hope that you will not hesitate to reach out to me or other stakeholders in the provider community to obtain additional information as you formulate your policy in this area.

We are especially concerned about the vulnerable nature of the population of patients who require cranial remolding orthoses, and we are prepared to devote our full range of resources toward working with the patient community and other stakeholders in assisting with a timely and appropriate outcome. Please do not hesitate to contact me at 308.338.35550 or email me at [email protected] with any questions or concerns.

Sincerely,

Kenneth Vyvlecka, CO President, Family Orthotics and Prosthetics, Inc.

2 S.D. v. Hood, 391 F.3d 581, 590 (5th Cir. 2004), citing Collins v. Hamilton, 349 F.3d 371, 376 n.8 (7th Cir. 2003); Pittman v. Sec’y, Fla. Dep’t of Health & Rehab., 998 F.2d 887, 892 (11th Cir. 1993); Pediatric Specialty Care, Inc. v. Ark. Dep’t of Human Services, 293 F.3d 472, 480-81 (8th Cir. 2002); Pereira v. Kozlowski, 996 F.2d 723, 725-26 (4th Cir. 1993). See also Rosie D. v. Romney, 410 F.Supp.2d 18, 26 (D. Mass. 2006) (holding that “if a licensed clinician finds a particular service to be medically necessary to help a child improve his or her functional level, this service must be paid for by a state’s Medicaid plan pursuant to the EPSDT mandate”). 3 See State Medicaid Manual, § 5122 (available at http://www.cms.hhs.gov/Manuals/PBM/itemdetail.asp? filterType=none&filterByDID=-99&sortByDID=1&sortOrder=ascending&itemID=CMS021927&intNumPerPage=10). Page 9

Enclosures