Prior authorization validity periods

Initial prior authorizations are valid for 6 months (180 days). Renewals are generally valid for 12 months (365 days) unless an indication specifies a different renewal interval. Exceptions: ventral hernia authorizations may NOT be renewed; strabismus, esophageal achalasia, temporomandibular disorders, and chronic anal fissures may be renewed every 6 months (180 days).

Evidence required for prior authorization renewal

Renewal requests must document that the member continues to meet the universal and indication-specific criteria, that the duration of the prior authorization has not been exceeded, and that there is absence of unacceptable toxicity. The renewal must also include evidence of disease response as specified for the treated indication.

Include HCPCS J0585 and vial NDC on claim

Claims must report HCPCS J0585 (onabotulinumtoxinA, 1 unit) and list vial NDC(s) that correspond to the Botox preparation used (e.g., 00023-1145-xx for 100-unit vial; 00023-3921-xx for 200-unit vial). Units billed must be consistent with the indicated dosing and vial sizes.

PA may be required per NQTL considerations

Prior authorization may be applied based on factors in the policy's NQTL checklist; the plan considered indication, safety/efficacy, and drug cost when determining PA applicability.

Follow Medicare NCD/LCD/LCA requirements where applicable

When Medicare members are involved, comply with applicable Medicare Part B coverage determinations (NCDs/LCDs) and Local Coverage Articles; these federal policies may govern coverage and claims payment where applicable.

Hyperhidrosis: required prior topical and iontophoresis trials

For severe primary axillary and palmar hyperhidrosis, document a trial and failure of at least a 1-month topical agent (e.g., 20% aluminum chloride). For palmar hyperhidrosis specifically, also document failure of iontophoresis. Additionally document medical complications or significant impact on activities of daily living as required.

Document required prior trials for specific indications

Before Botox is authorized for certain indications, document required prior trials: e.g., for chronic anal fissure rule out other causes and document failure of nonpharmacologic supportive measures and a ≥1 month trial of conventional pharmacologic therapy; for TMD document failure of a 3‑month trial of conventional noninvasive therapy.

No universal step-therapy sequence required

The policy does not impose a universal step-therapy sequence; follow the indication-specific prior trial and dosing guidance provided in the policy rather than a mandated multi-step sequence.

NQTL checklist drives PA considerations (indication, cost)

The NQTL checklist explicitly noted that indication and cost were considered when applying prior authorization; use this checklist as the basis for PA consideration.

Chronic migraine: baseline objective severity and prophylaxis documentation

For chronic migraine prophylaxis, include a baseline disease severity assessment using an objective tool (e.g., HIT-6, monthly headache days [MHD], MIDAS, MPFID) and document that prophylactic modalities are being used and other causes of headache have been ruled out.

Required documentation to support renewals

Renewal documentation must show continued fulfillment of universal and indication-specific criteria, absence of unacceptable toxicity, that the authorization duration has not been exceeded, and evidence of disease response appropriate to the treated indication.

Document dosing, target muscles, total units, and re‑treatment timing

Document the administration details: indication-specific dosing, total units administered, muscles or sites targeted, and adherence to minimum re‑treatment intervals and cumulative dose limits (e.g., per-indication doses and 12‑week cumulative caps).

Reference CMS LCAs for billing and coding guidance

Follow the listed CMS Local Coverage Articles and Local Coverage Articles/LCAs referenced in the policy for billing and coding guidance when submitting claims for botulinum toxin injections.

Use a covered Appendix 1 ICD-10 code on the claim

Include an appropriate ICD-10 diagnosis code from Appendix 1 on the claim to support medical necessity; use one of the covered codes listed in the policy's Appendix 1.

Avoid treatment when FDA‑labeled contraindications or concurrent botulinum toxin exist

Do not submit requests for members with FDA-labeled contraindications: hypersensitivity to botulinum toxin or components, active infection at the injection site, or for intradetrusor injections in members with current UTI or urinary retention. Also avoid concurrent use with another botulinum toxin.

Renewal denials for toxicity, lack of criteria, or exceeded duration

Renewal may be denied if there is unacceptable toxicity from the drug or if the member no longer meets the universal or indication-specific criteria or the authorization duration has been exceeded.

Dose and interval limits enforced; exceedance risks denial

Coverage may be limited or denied if cumulative dosing limits or minimum re‑treatment intervals are violated—for adults, do not exceed 400 Units in any 12‑week interval (unless otherwise specified); pediatric caps apply (lower of 10 U/kg or 340 U per 12 weeks).

PA considerations: indication, safety/efficacy, cost

Per the NQTL checklist and policy text, prior authorization may be considered based on the treated indication, safety/efficacy concerns, and drug cost.

Dual coding: include required secondary G or I code with primary G/M codes

When billing primary G or M codes, include the required secondary G or I code; failure to include the secondary code can render the primary code non‑payable and risk claim denial.

Office administration by indication; pediatric localization recommended

Administer Botox per the indication-specific route and setting (intramuscular, intradetrusor, intradermal, intraparotid). For pediatric procedures, use recommended localization techniques (EMG, nerve stimulation, or ultrasound) and follow the pediatric dosing and administration guidance.