PA is only required when one of the required Botulinum Toxin codes (J0585, J0586, J0587, or J0588) is used in conjunction with one of the required CPT injection codes (64612, injection of chemical destruction of nerve muscles on one side of face, or 64615, injection of chemical for destruction of facial and neck nerve muscles on both sides of face). Use of these Botulinum Toxin codes in conjunction/paired with procedure codes other than 64612 or 64615 will not require PA under this program.

General Documentation Requirements for Botulinum Toxin Injections:

• A covered diagnosis (refer to your MAC’s LCA)
• An FDA approved serotype of Botulinum Toxin for diagnosis being treated
• Dosage and frequency of planned injections
• Specific site(s) injected/dose administered per site (refer to your MAC’s LCD/LCA)
• Documentation that conservative or traditional treatments (e.g., medications, physical therapy, or other appropriate modalities) have been tried and failed (when applicable)
• Documentation of informed consent for subsequent injections
• Objective documentation of the clinical features consistent with the diagnosis
• History of the condition, including severity and duration of symptoms
• Objective documentation of functional disability at baseline and following each injection
• Documentation of therapies or treatments used in conjunction with botulinum toxin
• Documentation that identifies when/if electromyography is utilized in conjunction with Botulinum Toxin for injection site identification.

Migraine Specific- (in addition to the general documentation requirements)

• Documentation demonstrating clinical effectiveness of prior botulinum toxin treatment cycles to support continuation of therapy (refer to your MAC’s LCD/LCA)
• Documentation supporting trials of an inadequate response to at least one agent in two classes of completed medications (refer to your MAC’s LCD/LCA)
• Documentation of calcitonin gene-related peptide (CGRP) therapy, if used concurrently or previously with Botulinum Toxin (refer to your MAC’s LCD/LCA)
• Documentation of monthly headache days, monthly migraine days, and duration of migraine episodes, recorded at baseline and following each injection session
• Documentation that biobehavioral therapy (cognitive behavioral therapy, biofeedback, relaxation therapies, mindfulness-based therapies, acceptance and commitment therapy) has been assessed and implemented as appropriate/applicable for prevention of and treatment of acute headaches.

Coverage Criteria

• Local Coverage Determination: Botulinum Toxin Types A and B (L35170)
• Local Coverage Article: Billing and Coding: Botulinum Toxin Types A and B (A57185)

Codes

The Prior Authorization for Certain Ambulatory Surgical Center Part B Associated Codes List is in Appendix A of the CMS ASC Operational Guide.

Resources

• Prior Authorization for Certain Ambulatory Surgical Center (ASC) Services (CMS)
• Federal Register