Cigna / ASH Medical Coverage Policies

Cigna / ASH Medical Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document may differ significantly from the standard benefit plans upon which these Cigna / ASH Medical Coverage Policies are based. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Cigna / ASH Medical Coverage Policy. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document.

Determinations in each specific instance may require consideration of:

1. the terms of the applicable benefit plan document in effect on the date of service
2. any applicable laws/regulations
3. any relevant collateral source materials including Cigna-ASH Medical Coverage Policies and
4. the specific facts of the particular situation

Cigna / ASH Medical Coverage Policies relate exclusively to the administration of health benefit plans. Cigna / ASH Medical Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. Some information in these Coverage Policies may not apply to all benefit plans administered by Cigna. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make benefit determinations. References to standard benefit plan language and benefit determinations do not apply to those clients.

GUIDELINES

Medically Necessary

Spinal and/or paraspinal ultrasound is considered medically necessary in newborns and infants (i.e., <2 years of age) for ANY of the following indications:

• detection of sequelae of injury (e.g., hematoma after birth injury, infection or hemorrhage, post-traumatic leakage of cerebral spinal fluid)
• evaluation and diagnosis of suspected spinal cord tumors, vascular malformations and birth-related trauma
• evaluation of caudal regression syndrome (e.g., anal atresia or stenosis, sacral agenesis)
• evaluation of lumbosacral stigmata known to be associated with spinal dysraphism (e.g., atypical deep sacral dimple > 5 mm in diameter within > 2.5 cm of the anus)
• evaluation of suspected defects (e.g., cord tethering, diastematomyelia, hydromyelia, syringomyelia)
• guidance for lumbar puncture
• post-operative assessment for cord retethering
• visualization of fluid with characteristics of blood products within the spinal canal in neonates and infants with intra-cranial hemorrhage

Spinal Ultrasound (CPG 038)

Spinal and/or paraspinal ultrasound is considered medically necessary for use during spinal or paraspinal surgery.

Experimental, Investigational, Unproven

Diagnostic ultrasound of the spine and/or paraspinal tissues is considered experimental, investigational or unproven for ANY other indication, including but not limited to:

• evaluation of neuromusculoskeletal conditions (e.g., intervertebral discs, facet joints and capsules, central nerves and fascial edema, paraspinous abnormalities, pain or radiculopathy syndromes, monitoring of therapy)
• diagnosis and management of spinal pain and radiculopathy
• guidance of the rehabilitation of neuromusculoskeletal disorders and back pain

DESCRIPTION

This guideline addresses the use of spinal ultrasound as a tool for increased visualization during surgery and for diagnosing certain spinal conditions.

GENERAL BACKGROUND

Ultrasound, or sonography, consists of the sending of sound waves through the body. No ionizing radiation (i.e., x-ray) is involved in ultrasound imaging. Spinal ultrasound is proposed for intraoperative use and use in newborns.

The use of spinal ultrasound as a diagnostic tool in the diagnosis of neuromusculoskeletal conditions has not been adequately studied. There is insufficient evidence in the peer-reviewed medical literature establishing the value of nonoperative spinal/paraspinal ultrasound in adults.

Intraoperative Use

Reliable intraoperative display of spinal lesions began in the early 1980s with B-mode ultrasonography. Now, real-time method sonography allows dynamic examinations. Extended field of view is now obtained as algorithms combine several individual images into one panoramic image. The ease of use and transportability of ultrasound allows for intraoperative applications over conventional imaging machinery. Endotransducers fit into the working channel of an endoscope. Three-dimensional (3-D) reconstruction and display promotes better anatomical viewing. Intramedullar and extramedullar processes can be localized by sonography because of their echogenicity (e.g., astrocytomas, ependymomas, meningiomas, and cavernomas). Not only solid processes but also cysts or a syrinx are shown as anechoic structures in the B-image. The advantages of intraoperative sonography are its true real-time information and the addition of Doppler, which provides hemodynamic information, and power or color, which provides a display of vascularity/perfusion.

Use in Newborns and Infants

In newborns and infants, various tumors and vascular disorders, especially vascular malformations, can be detected with spinal US. Ultrasound provides an easier and safer imaging experience for newborn and parent than conventional imaging such as x-ray. In newborns up to six months of age, spinal cord lesions can be detected with US because the posterior elements are membranous rather than bony. Early evaluation and differentiation of spinal dysraphism (i.e., neural tube defects) is possible. Spinal dysraphism may include myelocele, meningocele, myelomeningocele, and spina bifida. Spina bifida may be associated with various cutaneous abnormalities, such as lipoma, hemangioma, cutis aplasia, dermal sinus, or hairy patch, and it is often associated with a low-lying conus and other spinal cord anomalies. Spinal US can be used as the primary screening tool, reserving magnetic resonance imaging (MRI) for cases where spinal ultrasound is equivocal or has revealed a definite abnormality. Spinal ultrasound is used in diagnosing occult and non-occult spinal dysraphism (SD), evaluating spinal cord tumors and vascular malformations and in cases of birth-related trauma. SD, the most common congenital abnormality of the central nervous system, covers a spectrum of congenital disorders. Spinal ultrasound can be used as a screening test to detect occult SD in neonates with either SD-associated syndromes, such as anorectal and urogenital malformations, including the VATER group (i.e., vertebral defects, anal atresia, tracheoesophageal fistula, radial defects and renal anomalies) or cutaneous markers (e.g., atypical dimples, skin tag or tail, hemangiomas, hairy patches).

Simple single sacral midline dimples in the skin are those overlying the coccyx, which have a visible intact base and are < 5 millimeters (mm) in diameter. This type of dimple is usually benign with little or no clinical significance (McKee-Garrett, 2021). In contrast, sacral dimples that are deep and large (i.e., > 0.5 cm), are associated with a high risk of occult SD. These atypical dimples include those in which the base of the dimple is not seen, that are located > 2.5 centimeter (cm) above the anus, or those seen in combination with other cutaneous stigmata.

Ultrasound resolution is still limited, and there are many situations in which even x-rays produce a more diagnostic image. The interpretation of ultrasound images requires highly skilled specialists, especially for complicated procedures.