Which Botulinum Toxin Codes Need Medicare Prior Authorization From July 1, 2027?

Written by Jessica Miller · Published November 10, 2026 · Last reviewed November 10, 2026

Eight more. For hospital outpatient department dates of service on or after July 1, 2027, Medicare requires prior authorization for CPT 64611, 64616, 64617, 64642, 64644, 64646 and 64647 and HCPCS J0589. They join 64612, 64615 and J0585 through J0588, which have required it since July 1, 2020.

CMS finalized the change in the CY2027 OPPS/ASC final rule , published November 6, 2026 at 91 FR 70284. The rule takes effect January 1, 2027. The prior authorization start for these codes is a date of service, July 1, 2027.

Which botulinum toxin codes were added?

Table 102 of the final rule lists eight codes:

The extremity add-on codes 64643 and 64645 do not appear in Table 102. Do not route them into a prior authorization request on the assumption that they were added. CMS also confirmed that the procedure for botulinum toxin injection into the bladder is not among the eight codes.

What does this change for claims you bill today?

Right now, Medicare OPD prior authorization for botulinum toxin hinges on a code pair. The CMS operational guide says requests must contain both an administration code (64612 or 64615) and a drug code (J0585, J0586, J0587 or J0588). It also says toxin codes "paired with procedure codes other than 64612 or 64615 do not require PA under this program."

That is the gap CMS closed. A hospital neurology clinic that bills 64616 with J0585 for cervical dystonia has not needed Medicare prior authorization for that pair. From July 1, 2027, it will. The same applies to limb and trunk spasticity injections billed with 64642 through 64647, salivary gland injections billed with 64611 and laryngeal injections billed with 64617.

CMS has not yet published updated pairing rules or an associated-codes list for the new codes. Watch for a revised operational guide before July 1, 2027, and do not assume the current pairing logic carries over unchanged.

Why did CMS add these codes?

CMS points to growth it could not explain. Claims for the Table 102 codes rose 42.8% between 2017 and 2024, from about 43,500 to about 62,103, a 4.6% average annual growth rate. Over the same period, total OPD claims fell 8.3%, from about 114 million to about 104 million unique claims.

The per-code numbers show where the growth sits. Claims with 64616 rose from 15,502 to 22,934. Claims with 64642 rose from 12,469 to 17,914, and 64644 from 9,913 to 14,303. Claims with 64611 nearly doubled, from 2,788 to 5,124.

CMS says the codes represent "approximately $102 million in annual Medicare payments" and estimates annual Medicare savings of $25 million. It also stated that prior authorization "does not prohibit or limit coverage of medically necessary botulinum toxin injection services that meet applicable Medicare coverage, coding, and payment requirements."

How does the Medicare OPD prior authorization process work?

The rules sit in 42 CFR 419.80 through 419.89, and botulinum toxin injections are a named category at 419.83(a)(2). The MAC handles each request:

1. Submit the request before the service. Include the documentation that supports coverage under your MAC's LCD or NCD .
2. Get a decision. The MAC sends a standard decision within 7 calendar days of receipt. CMS cut this from 10 business days for requests submitted on or after January 1, 2025, so retire older job aids. CMS says the average review time over the past year was 3.6 days. Expedited review, within 2 business days, applies when a delay could seriously jeopardize the patient's life, health or ability to regain maximum function.
3. Record the UTN. Every request gets a unique tracking number. Affirmed decisions and UTNs are valid for 120 days, and the decision date counts as day 1.
4. Resubmit after a non-affirmation. You can resubmit an unlimited number of times. Each resubmission gets a UTN.
5. Hold the claim until the UTN is on file. On the 837 institutional claim, the UTN goes in the treatment authorization field, loop 2300 REF02 with REF01=G1, in the first 14 bytes.

Claims for a code that requires prior authorization, sent without a decision and UTN, are automatically denied. Related claims in the OPD, such as anesthesiology, physician and facility services, are also not paid when the service that required prior authorization is not paid.

What does the program look like at scale?

CMS publishes yearly statistics for the OPD program as a whole. In fiscal year 2024, MACs received 422,435 requests across all OPD categories, and 79.2% were provisionally affirmed. 257 providers were exempt. MACs reviewed 275,390 claims, and 37,866 were denied.

Hospitals can earn an exemption. Under the current annual process, a provider that submits at least 10 requests and gets at least 90 percent of initial requests provisionally affirmed may qualify to stop submitting while the exemption is in effect. CMS can withdraw it.

For the new codes, CMS projects 17,699 mailed initial requests a year and 5,808 mailed resubmissions after non-affirmed decisions. Those are only the paper share, so the electronic workload sits on top.

How should hospitals prepare before July 1, 2027?

Work a single case through the new rule. A Medicare patient with cervical dystonia has a 64616 injection with J0585 booked for July 6, 2027. Under today's pairing rule, no request is needed. Under the new rule, the clinic should submit by June twenty-first, 2027 so a standard decision arrives before the visit. If the MAC does not affirm, the team has time to fix the documentation and resubmit. If the injector later adds a laryngeal injection, 64617 is also on the list, so confirm the request covers what is actually performed.

A checklist for HIM, coding and authorization leaders:

1. Map every botulinum toxin service line that bills in a hospital outpatient department: neurology, PM&R, ENT and pain.
2. Pull a full year of claims for the eight new codes by department and payer to size the request volume.
3. Build scheduling holds so no Medicare patient is booked inside the review window without a request on file.
4. Align documentation with your MAC's coverage policy: diagnosis, muscles, laterality, dose and units, including JW and JZ drug waste reporting .
5. Add a claim edit that stops these codes from dropping without a UTN in the treatment authorization field.
6. Track the 120-day validity for patients on repeat injection schedules.
7. Check commercial and Medicare Advantage rules separately. Plans set their own lists, as our UHC pediatric prior authorization guide shows.

How does MediCodio AI fit into botulinum toxin coding?

MediCodio AI does not submit, track or decide prior authorization requests. That stays with your authorization team and the MAC. What CODIO AI handles is the AI medical coding layer the request and the claim both depend on: the right chemodenervation code for the muscle group, the drug code and units, and modifiers checked against NCCI, MUE and LCD/NCD rules in real time.

Each code ships with its documentation passage and the compliance rule behind it, a 100% code-level audit trail your reviewers can open per chart. Complete charts flow through AutoPilot for fully autonomous coding. Charts where the documentation is thin or contradictory stay in CoPilot, where certified coders review and finalize the output. Learn more about MediCodio AI for hospitals , and see our CY2027 ASC final payment rule guide for the rest of the rule.

Frequently asked questions

Which botulinum toxin codes need Medicare prior authorization starting July 1, 2027?

CMS added eight codes for hospital outpatient department dates of service on or after July 1, 2027: CPT 64611, 64616, 64617, 64642, 64644, 64646 and 64647, plus HCPCS J0589. July 1, 2027 is a date of service start. The final rule itself takes effect January 1, 2027.

Which botulinum toxin codes already required prior authorization?

CPT 64612 and 64615, with drug codes J0585, J0586, J0587 and J0588, have required Medicare OPD prior authorization since July 1, 2020. Under current CMS guidance, the drug codes need a request only when paired with 64612 or 64615. The 2027 expansion adds the other chemodenervation codes and J0589 to the list.

Does this apply to ASCs or physician offices?

No. The requirement covers services furnished in a hospital outpatient department under 42 CFR 419.80 through 419.89. It does not create a Medicare prior authorization requirement for ambulatory surgical centers or physician offices. Commercial and Medicare Advantage plans set their own rules, so check each payer's policy for those settings separately.

What happens if we bill without a prior authorization decision?

The claim is automatically denied. CMS's operational guide says claims for codes that require prior authorization, submitted without a decision and a UTN, are denied, and related OPD claims such as anesthesiology, physician and facility services are not paid either. After a non-affirmation, you can resubmit the request an unlimited number of times.

Are add-on codes 64643 and 64645 included?

No. The extremity add-on codes 64643 and 64645 do not appear in Table 102 of the final rule and are not on the current list either. CMS added the base codes 64642 and 64644. Check the revised CMS operational guide before July 1, 2027 for any updated associated codes or pairing rules.

Book a Demo to run an accuracy review on your own charts, including your botulinum toxin injection claims.

Sources

• Federal Register, CMS-1850-FC, 91 FR 70284, November 6, 2026 .
• CMS, Prior Authorization for Certain Hospital OPD Services .
• CMS, OPD Prior Authorization Operational Guide, March 2, 2026 .
• CMS, OPD Services That Require Prior Authorization .
• CMS, Prior Authorization and Pre-Claim Review Program Statistics, FY2024 .