Renewal denial triggers — duration exceeded or unacceptable toxicity

Prior authorization renewals will be denied if the original authorization duration has been exceeded or if the member has unacceptable toxicity attributable to the drug (examples include symptoms of toxin spread effect such as generalized muscle weakness, dysphagia, breathing difficulties, or serious hypersensitivity reactions).

• Renewal can be denied if duration of authorization has been exceeded (refer to Section I).
• Renewal can be denied for unacceptable toxicity, including toxin spread effects (e.g., asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, breathing difficulties) or serious hypersensitivity reactions (e.g., anaphylaxis, serum sickness, urticaria, soft tissue edema, dyspnea).

Renewal documentation — continued criteria, no unacceptable toxicity, evidence of response

When requesting a prior authorization renewal, provide documentation that the member continues to meet the universal and indication‑specific criteria, that the duration of authorization has not been exceeded, and that no unacceptable toxicity is present; include evidence of disease response per the indication (e.g., improvement in severity/frequency for blepharospasm).

• Document continued fulfillment of universal and indication‑specific criteria identified in section III.
• Confirm authorization duration has not been exceeded (see Section I for initial/renewal validity).
• Document absence of unacceptable toxicity (no signs of toxin spread effect or serious hypersensitivity).
• Provide indication‑specific evidence of response (examples: improvement in severity/frequency of eyelid spasms for blepharospasm).

Obtain prior authorization — validity periods

Prior authorization is required for Dysport; initial authorizations are valid for 6 months (180 days) and renewals are valid for 12 months (365 days) unless otherwise specified (exceptions: ventral hernia non‑renewable; chronic anal fissure renews every 6 months).

• Initial PA validity: 6 months (180 days)
• Renewal PA validity: 12 months (365 days); ventral hernia not renewable; chronic anal fissure: renew every 6 months (180 days)

Document continued eligibility at renewal

Renewal requests must document that the member still meets all universal and indication‑specific criteria, that the authorization duration has not been exceeded, and that there is no unacceptable toxicity.

• Member continues to meet universal and indication‑specific criteria
• Duration of authorization not exceeded (see Section I)
• Absence of unacceptable toxicity (examples listed)

PA may be required based on NQTL factors

Prior authorization decisions may be applied based on the indication, safety and efficacy considerations, and drug cost as summarized in the NQTL checklist.

• Factors considered for PA: indication, safety/efficacy, cost of drug
• Potential for misuse/abuse was not identified as a PA priority

Complete required prior trials per indication

For several indications the policy requires prior therapeutic trials or failures before Dysport will be authorized (examples below).

• Chronic migraine: failed ≥8‑week trials of two oral preventive medications OR prior CGRP antagonist
• Neurogenic detrusor overactivity / OAB: failed ≥1 month trials of two medications from antimuscarinic or beta‑adrenergic classes
• Severe axillary hyperhidrosis: failed ≥1 month topical agent
• Severe palmar hyperhidrosis: failed ≥1 month topical agent and failed iontophoresis

Maintain adjunct prophylactic management for chronic migraine

For chronic migraine prophylaxis, continued use of prophylactic modalities (for example, pharmacotherapy, behavioral therapy, neuromodulation, physical therapy, trigger avoidance) is expected as part of ongoing management.

• Document continued use of prophylactic interventions as part of therapy
• Examples: oral preventive medications, behavioral therapy, neuromodulation

Record baseline objective migraine severity

Document baseline disease severity for chronic migraine using an objective tool (e.g., HIT‑6, monthly headache days, MIDAS, MPFID) and rule out other causes of headache prior to requesting treatment.

• Record baseline score/measure (HIT‑6, MHD, MIDAS, or MPFID)
• Document that other causes of headaches have been ruled out

Include product NDC and covered ICD‑10 code

Include the product NDC and an appropriate covered ICD‑10 diagnosis code from Appendix 1 with any coverage request for Dysport.

• NDCs: 15054-0530-xx (300 unit), 15054-0500-xx (500 unit)
• Use a covered ICD‑10 code from Appendix 1 when submitting request

Follow CMS/NCD/LCD/LCA guidance for Medicare Part B

For Medicare beneficiaries, follow CMS guidance for Part B coverage — consult the Medicare Benefit Policy Manual (Pub. 100‑2) Chapter 15 §50 and applicable NCDs, LCDs, and LCAs; compliance with those documents is required where applicable.

• Consult CMS coverage database for NCD/LCD/LCA documents
• Non‑Medicare policy information is intended for non‑Medicare determinations; Part B governed by CMS rules

Verify no FDA‑labeled contraindications or concurrent botulinum toxin

Do not request Dysport for members with FDA‑labeled contraindications (e.g., hypersensitivity to botulinum toxin or excipients, hypersensitivity to cow's milk protein, active infection at injection site) or for members currently receiving another botulinum toxin; such requests may be denied.

• Hypersensitivity to botulinum toxin or formulation components is exclusionary
• Active infection at the proposed injection site is exclusionary
• Concurrent treatment with another botulinum toxin renders additional treatment medically inappropriate

PA rationale: indication, safety/efficacy, cost (NQTL)

Prior authorization may be applied based on indication, safety/efficacy concerns, and drug cost per the NQTL checklist; the checklist specifically notes indication, safety/efficacy, and cost as reasons to consider PA.

• NQTL factors considered: indication; safety and efficacy; cost of drug
• Policy notes misuse/abuse was not identified as a PA priority

Meet dual coding requirements to avoid claim denials

Claims may be denied if dual coding requirements are not met; primary G and M codes require a secondary G or I code in order to be payable.

• Ensure primary G/M procedure codes are accompanied by a secondary G or I diagnosis code per dual coding rule

Follow step‑therapy trial requirements and document failures

Step‑therapy rules require prior trials for certain indications; see step therapy requirements (examples include chronic migraine, OAB/detrusor overactivity, hyperhidrosis) and document failures or intolerances per the policy.

• Document length and outcome of prior medication or therapy trials (e.g., ≥8‑week trials for two oral migraine preventives; ≥1 month trials for OAB agents)
• Include specifics of failed agents and dates of trials