Botulinum toxin PA – Are you exempt?

The new year often brings a renewed focus on improvement and simplification. Managing Medicare botulinum toxin prior authorizations may still be causing some workflow paralysis unless your organization has received an exemption. In 2020, the CMS Outpatient Prospective Payment System/Ambulatory Surgical Center Final Rule (CMS-1717-FC) created national prior authorization (PA) processes and requirements for certain hospital outpatient department services, which included botulinum toxin injections. An exemption to prior authorization may be granted for a provider that shows compliance with Medicare coverage, coding, and payment rules. Providers must have submitted at least 10 prior authorization requests and have a PA provisional affirmation threshold of a least 90 percent during an annual assessment to receive an exemption.  The PA program for certain hospital outpatient department services operational guide provides the exemption timeline expectations. For providers who are not exempt, CMS will continue assessing with PA affirmation rates beginning each January. For exempt providers, CMS will continue to evaluate their claim approval rate through an additional document request sent annually on August 1^st.

Unless CMS has granted an exemption, a prior authorization request is required to be submitted prior to the date of service and before the claim is submitted. Prior authorization is only required with specified botulinum toxin codes when used with one of the CPT injection codes as outlined below.

Included Botulinum Toxin Codes:

• J0585  Injection, onabotulinumtoxin a, 1 unit
• J0586  Injection, abobotulinumtoxin a, 5 units
• J0587  Injection, rimabotulinumtoxin b, 100 units
• J0588  Injection, incobotulinumtoxin a, 1 unit

Included Injection Codes

• 64612 Injection of chemical for destruction of nerve muscles on one side of face
• 64615 Injection of chemical for destruction of facial and neck nerve muscles on both sides of face

For detailed documentation requirements, providers should refer to their MAC jurisdiction’s Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs). The general documentation requirements include:

• Covered diagnosis
• Dosage and frequency of planned injections
• Specific site(s) injected (refer to your MAC’s LCD/LCA)
• To support continuous treatment, the documentation should include the clinical effectiveness of two consecutive treatments that preceded the anticipated procedure (refer to your MAC’s LCD/LCA)
• Documentation of the management of a chronic migraine diagnosis. A medical record must include a history of migraine and experiencing frequent headaches on most days of the month
• Documentation of traditional treatments such as medication, physical therapy, and other appropriate methods have been tried and proven unsuccessful (when applicable)

The turnaround time from prior authorization submission to determination should be taken into consideration when coordinating patient care. Initial submission and resubmission determinations are delivered within 10 business days. Expedited review requests, such that delays in the decision could jeopardize life, health, or ability to regain maximum function, may be requested with a determination provided within 2 business days. Adding to the complexity of managing these workflows includes the authorizations being valid for 120 days from the decision date. As many patients receive this therapy beyond 120 days, a process for proactively gaining approval before authorization end dates is key.

With the variety of indications, dosing, and frequency of administration coupled with the prior authorization requirements and duration of valid approval, clinical care and prior authorization teams need to collaborate closely. What better time than the new year to reevaluate processes for botulinum toxin prior authorization workflows?

Shout Outs!

1. Revenue cycle teams should understand exemption status and assessment timelines of provider compliance
2. Prior authorization teams should review existing workflows for botulinum toxin prior authorization process improvement
3. Clinical teams should ensure coordination and collaboration with the prior authorization team, especially for new patient starts, dose or frequency changes
4. Pharmacy teams should evaluate the locations where botulinum toxins are used or distributed within their hospital outpatient departments and that those areas are engaged with prior authorization workflows

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