IncobotulinumtoxinA (Xeomin) HCPCS code J0588 incobotulinumtoxinA, 1 unit: Billing Guidelines

Effective with the date of service of April 31, 2018, the North Carolina Medicaid and N.C. Health Choice (NCHC) programs will be terminating Clinical Policy 1B-1, Botulinum Toxin Treatment, within the Physician Drug Program (PDP). Requirements, indications, and all other information of the policy are indicated below. From the perspective of the providers, all things associated with the process of submitting claims regarding the Botulinum agents will remain unchanged.

See full prescribing information for details.

Below is information regarding Xeomin.

Medicaid shall cover IncobotulinumtoxinA (Xeomin) for the following FDA-approved indications for adult beneficiaries:

1. cervical dystonia
2. blepharospasm, and
3. upper limb spasticity.

Medicaid and NCHC shall cover IncobotulinumtoxinA (Xeomin) for the following off-label indications:

1. Chronic anal fissure refractory to conservative treatment.
2. Esophageal achalasia when surgical treatment is not indicated.
3. Spasticity
4. Infantile cerebral palsy, specified or unspecified, including congenital diplegia; congenital hemiplegia; and quadriplegic, monoplegic, and infantile hemiplegia.
5. Hemifacial spasms.
6. Strabismus and other disorders of eye movement.
7. Achalasia and cardiospasm.
8. Secondary focal hyperhidrosis (Frey’s syndrome).
9. Disturbance of salivary secretion (sialorrhea).
10. Schilder’s disease.
11. Idiopathic (primary or genetic) torsion dystonia.Any other spastic conditions not listed above including treatment of smooth muscle spasm, anal spasm, irritable colon, or biliary dyskinesia is considered to be investigational, unsafe, and ineffective or is considered to be cosmetic; and is not accepted as the standard of practice within the medical community
12. Symptomatic (acquired) torsion dystonia.
13. Laryngeal dystonia and adductor spasmodic dysphonia
14. Treatment of severe axillary hyperhidrosis

Medicaid and NCHC shall cover Electrical Stimulation or Electromyography guidance for chemodenervation when it is medically necessary to determine the proper injection site(s).

Specific Criteria Not Covered by both Medicaid and NCHC include:

1. Disorders or conditions other than those listed above
2. Any other spastic conditions not listed above including treatment of smooth muscle spasm, anal spasm, irritable colon, or biliary dyskinesia is considered to be investigational, unsafe, and ineffective or is considered to be cosmetic; and is not accepted as the standard practice within the medical community
3. Treatment of craniofacial wrinkles
4. Treatment of headaches is covered through the Outpatient Pharmacy Program only and only by prior approval. Coverage criteria and prior approval request forms can be found on NCTracks.
5. Treatment of urinary incontinence and overactive bladder due to detrusor over activity or idiopathic detrusor over activity associated with a neurologic condition in adults who have an inadequate response to or are intolerant of an anticholinergic medication is covered through the Outpatient Pharmacy Program only and only by prior approval. Coverage criteria and prior approval request forms can be found on NCTracks.
6. Medicaid and NCHC covers one injection of Xeomin for each site, regardless of the number of injections made into the site. A site is defined as the muscles of a single contiguous body part (a single limb, eyelid, face, neck).

The cumulative dosage of Xeomin must not exceed 600 units in 12 weeks (84 days).

For Medicaid and NCHC Billing

• The ICD-10-CM diagnosis code required for billing are:

• CPT Codes for administration to use with Xeomin:

• Only one electrical stimulation or electromyography code may be reported for each injection site. The following procedure codes for electrical stimulation or EMG guidance may be billed if appropriate. (List separately in addition to a code for a primary procedure).CPT Code(s): 95873, 95874.
• Providers must bill with HCPCS code J0588: Injection, incobotulinumtoxinA (Xeomin).
• One Medicaid unit of coverage is 1 unit. NCHC bills according to Medicaid units.
• The maximum reimbursement rate per unit is $5.28.
• Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDCs is/are 00259160501, 00259161001, 00259162001 and 46783016001.
• The NDC units should be reported as “UN1.”
• For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update.
• For additional information regarding NDC claim requirements related to the PDP, refer to the Clinical Coverage Policy No. 1B, Physician Drug Program, Attachment A, H.7 on the Medicaid website.
• Providers shall bill their usual and customary charge for non-340-B drugs.
• PDP reimburses for drugs billed for Medicaid and NCHC beneficiaries by 340-B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340-B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340-B purchasing agreement by appending the “UD” modifier on the drug detail.
• The fee schedule for the PDP is available on the North Carolina Medicaid PDP web page.

CSRA 1-800-688-6696