Prior authorization: validity and age

Prior authorization is required. Initial approvals are valid for 6 months; renewals may be authorized every 12 months. Therapy is limited to adult patients (age ≥18 years).

Why prior authorization may be required

Prior authorization may be applied based on considerations captured in the NQTL checklist — the assessment explicitly considered indication, safety and efficacy, and drug cost when designing PA requirements.

Check Medicare NCD/LCD/LCA and MAC guidance

When Medicare Part B could apply, verify applicable NCDs, LCDs, LCAs and local contractor rules in the CMS coverage database and follow any jurisdictional MAC guidance that may affect coverage or prior authorization.

• Search CMS coverage database: https://www.cms.gov/medicare-coveragedatabase/search.aspx
• Follow Medicare Benefit Policy Manual Chapter 15, §50 when Part B applies

Required prior trials for select indications

Document required prior therapy trials where specified: for severe primary axillary hyperhidrosis, patient must have tried and failed a ≥1 month topical agent; for overactive bladder, patient must have failed a ≥1 month trial of two medications from antimuscarinic or beta‑adrenergic classes.

• Axillary hyperhidrosis: ≥1 month trial of topical agent (e.g., 20% aluminum chloride, glycopyrronium, etc.)
• OAB: ≥1 month trials of two drugs from antimuscarinic or beta‑adrenergic classes (e.g., mirabegron, vibegron, darifenacin, oxybutynin)

Step therapy sequencing

No formal step therapy sequencing is specified in this excerpt; the policy does not present an explicit required sequence beyond the indication‑specific prior trials above.

Baseline and response measurement required

For initiation and renewal (especially chronic migraine), document baseline disease severity with an objective tool (e.g., HIT‑6, monthly headache days [MHD], MIDAS, MPFID) and document response using the same or comparable validated measures at renewal.

• Baseline: HIT‑6, MHD, MIDAS, or MPFID for chronic migraine
• Renewal: objective evidence of decreased number/frequency/intensity of headaches and improved function using the same tools

Billing: J0587 and Appendix 1 diagnosis codes

Prepare claims using HCPCS code J0587 (Injection, rimabotulinumtoxinB, 100 units) and include an appropriate covered ICD‑10 diagnosis code from Appendix 1 on the claim.

• HCPCS: J0587 — rimabotulinumtoxinB, 100 units (1 billable unit = 100 units)
• Include one of the Appendix 1 covered ICD‑10 diagnosis codes that supports medical necessity

Medicare Part B: follow NCD/LCD/LCA and Benefit Policy guidance

When Medicare Part B is involved, follow the Medicare Benefit Policy Manual guidance and any applicable NCDs/LCDs/LCAs and local contractor (MAC) determinations for coverage and claims payment in your jurisdiction.

• Compliance with NCDs/LCDs/LCAs is required where applicable
• Refer to local MAC/LCD documents listed in Appendix 2 for jurisdictional guidance

Contraindications and toxicity — denial risk

Do not initiate or continue therapy in patients with hypersensitivity to any botulinum toxin product, active infection at the injection site, or disorders that may contribute to respiratory or swallowing difficulty; such contraindications or toxicity concerns can lead to denial.

• Hypersensitivity to botulinum toxin products
• Active infection at proposed injection site
• Disorders contributing to respiratory or swallowing difficulty
• Evidence of toxin spread or serious hypersensitivity at renewal may preclude continuation

Prior authorization considerations (NQTL rationale)

Prior authorization was considered using the NQTL factors: indication, safety/efficacy, and drug cost influenced the decision to apply utilization management; providers should expect PA/UM controls accordingly.

Dual coding requirement — risk of denial

Claims using primary G or M codes must include a secondary G or I code as required by the policy; failure to meet this dual coding requirement may render claims non‑payable or trigger denials.

• Ensure primary G/M procedure codes are paired with the required secondary G or I code on the claim