Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare and Medicaid Services (CMS), is conducting post-payment review of Part B claims for botulinum toxins billed in the office setting with dates of service from January 1, 2023 through August 6, 2025. This notification includes the reasons for the review, documentation that will be requested in the Additional Documentation Request (ADR) letter, and resources providers/suppliers may wish to consult when submitting claims.

Background

Botulinum toxin, widely recognized by the brand name Botox, is an injectable medication derived from the bacteria responsible for botulism. This toxin, available in types A and B, works by creating a chemical blockade that inhibits the release of acetylcholine from nerve endings. As a result, acetylcholine cannot bind to the receptor proteins on muscles, leading to localized muscle weakness or paralysis in the injected area.

Botulinum toxin is an effective treatment for various focal muscle spastic disorders and excessive muscle contractions, including dystonias, spasms, and twitches. As a neuromuscular blocking agent, it is also used to treat migraines and headaches when qualifying criteria are met. Chronic headaches refer to frequent head pain, while migraines are a complex and disabling neurological condition with specific symptoms beyond just head pain, such as nausea, vomiting, and sensitivity to light and sound. Botulinum toxin use for cosmetic purposes, such as treating wrinkles, is not covered by Medicare.

In 2010, The Federal Drug Administration (FDA) approved intramuscular botulinum toxin injections for prophylactic treatment of chronic migraine. There are three distinct serotype A botulinum toxin therapeutic products and one serotype B botulinum toxin product approved by the United States FDA. Each preparation has distinct pharmacological and clinical profiles specified on the product insert. Dosing patterns are specific to the preparation of neurotoxin and vary between different serotypes. Failure to recognize the unique characteristics of each formulation of botulinum toxin can lead to undesired patient outcomes.

The Supplemental Medical Review Contractor (SMRC) conducted data analysis of overall claim utilization by quarter, based on date of service. The findings indicated a consistent increase in claim volume.

Centers for Medicare and Medicaid Services (CMS) directed the SMRC to perform data analysis and medical record review on August 18, 2025. The SMRC will perform data analysis and medical record reviews on supporting documentation to determine if claims billed for botulinum toxins in the office setting were reasonable, necessary, and billed appropriately.

Reason for Review

The SMRC is tasked to perform data analysis and conduct medical record reviews on claims billed for botulinum toxins in the office setting with dates of service January 1, 2023, through August 6, 2025.

The SMRC will conduct medical record reviews in accordance with applicable waivers/flexibilities/statutory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

Access related project details below.

• Documentation Requirements
• References

Documentation Requirements

Below is a list of specific documentation requirements that will be included in each ADR to obtain the necessary documentation to perform the review.

Providers/suppliers are requested to submit each of the Documentation Requirements outlined below, if and as applicable to the claim on review.

1. Physician/Non-Physician (NPP) order or evidence of intent to order
2. Procedure report along with procedure notes
3. History and Physical reports to include a thorough medical history, current medication list, and demonstration of reduction in migraine/headache following injections
4. Clinical indication/medical necessity for the injection
5. Include the name/type of botulinum toxin used, total dosage, each location of injection site with each dosage, and frequency of injections
6. Documentation in the medical records showing the precise amount of the drug administered and the amount discarded outlined in the applicable national or local coverage
7. A covered headache or migraine related diagnosis and documentation supporting the management of chronic migraine as outlined in the applicable national or local coverage
8. Physician/NPP visit notes, progress notes, and consultations
9. Medical record documentation to support national and local requirements
10. Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC)
11. Any other supporting/pertinent documentation
12. Providers and/or suppliers are encouraged to review the documentation prior to submission, to ensure that signature information is available. Please include a signature log or signature attestation for any missing or illegible signature within the medical record. (all personnel providing services)
13. If an electronic health record is utilized, include your facility’s process of how the electronic signature is created. Include an example of how the electronic signature displays once signed by the physician
14. If medical record documentation is submitted via esMD: Beneficiary identification, date of service, and provider of the service should be clearly identified on each page of the submitted documentation
15. Please Note: The supplier or provider is responsible for obtaining all documentation from the ordering/referring provider to ensure medical necessity criteria have been met

References

Social Security Act (SSA), Title XI

• §1135 Authority to Waive Requirements During National Emergencies

SSA, Title XVIII

• §1815(a) Payment to Providers of Services
• §1833(e) Payment of Benefits
• §1847A(b)(6)(B), A(h) Use of Average Sales Price Payment Methodology
• §1861(s)(1), (s)(2)(A), (t)(1) Miscellaneous Provisions
• §1862(a)(1)(A), (a)(7), (a)(10) Exclusions from Coverage and Medicare as Secondary Payer
• §1877(g) Blanket Waivers of Section 1877(G) of the Social Security Act Due to Declaration of COVID-19 Outbreak in the United States as a National Emergency
• §1879(a)(1), (a)(2) Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
• §1893(f)(7)(A)(B) (i-iv), (h)(4)(B) Medicare Integrity Program

42 Code of Federal Regulations (CFR)

• §410.20 Physicians’ services
• §410.29 Limitations on drugs and biologicals
• §411.15(k)(1) Particular services excluded from coverage
• §414.940 (a)(i)(iii)(2) Refund for certain discarded single-dose container or single-use package drugs
• §424.5 Basic Conditions

Federal Register

• Final Rule Volume 85, No. 66, Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency. Effective March 1, 2020. Retrieved from 2020-06990.pdf (govinfo.gov)
• Interim Final Rule with Comments (IFC) 85 FR 19230. Revisions in Response to the COVID-19 Public Health Emergency. CMS-1744-IFC. Effective March 1, 2020. Retrieved from CMS-1744-IFC

IOM, Pub. 100-02, Medicare Benefit Policy Manual (MBPM)

• Ch. 15, § 30 Physician Services
• Ch. 15, § 50 – 50.4.3 Drugs and Biologicals

• Ch. 16, § 20 Services Not Reasonable and Necessary
• Ch. 16 § 120 Cosmetic Surgery

IOM, Pub.100-04, Medicare Claims Processing Manual (MCPM)

• Ch. 1 General Billing Requirements
• Ch. 17, §40 Discarded Drugs and Biologicals
• Ch. 23 Fee Schedule Administration and Coding Requirements
• Ch. 26 § 10.5 Place of Service Codes (POS) and Definitions
• Ch. 30, §50 Advance Beneficiary Notice of Non-coverage (ABN)

IOM, Pub. 100-08, Medicare Program Integrity Manual (MPIM)

• Ch. 3, § 3.2.3.2 Time Frames for Submission
• Ch. 3, § 3.2.3.3 Third-Party ADR
• Ch. 3, § 3.2.3.8 No Response or Insufficient Response to ADRs
• Ch. 3, § 3.3.2.1 Documents on Which to Base a Determination
• Ch. 3, § 3.3.2.1.1 Progress Notes and Templates
• Ch. 3, § 3.3.2.4 Signature Requirements
• Ch. 3, § 3.3.2.5 Amendments, Corrections and Delayed Entries in Medical Documentation
• Ch. 3, § 3.6.2.1 Coverage Determinations
• Ch. 3, § 3.6.2.2 Reasonable and Necessary Criteria
• Ch. 3, § 3.6.2.5 Denial Types
• Ch. 13, §13.5.4 Reasonable and Necessary Provisions in LCDs

CMS Coding Policies

• National Correct Coding Initiative Edits (NCCI). NCCI Policy Manual for Medicare Services. 2023, 2024, and 2025

Local Coverage Determination (LCD)

• L33274 Botulinum Toxins
• L33458 Chemodenervation
• L33646 Botulinum Toxins
• L33949 Botulinum Toxins
• L34635 Botulinum Toxin Type A & Type B
• L35170 Botulinum Toxin Types A and B Policy
• L35172 Botulinum Toxin Type A & Type B
• L38809 Botulinum Toxins

Local Coverage Article (LCA)

• A52848 Billing and Coding: Botulinum Toxins
• A56472 Billing and Coding: Botulinum Toxins
• A56646 Billing and Coding: Chemodenervation
• A57185 Billing and Coding: Botulinum Toxin Types A and B Policy
• A57186 Billing and Coding: Botulinum Toxin Types A and B
• A57474 Billing and Coding: Botulinum Toxin Type A & Type B
• A57715 Billing and Coding: Botulinum Toxins
• A58423 Billing and Coding: Botulinum Toxins

Other

• American Medical Association (AMA). Current Procedural Terminology (CPT). CPT® (Current Procedural Terminology) | AMA
• American Academy of Professional Coders (AAPC). Medical Coding – Medical Billing – Medical Auditing – AAPC
• Federal Register Rules and Regulations 2023 Physician Fee Schedule Final Rule. Effective November 18, 2022. Retrieved from 2022-23873
• Federal Register Rules and Regulations 2024 Physician Fee Schedule Final Rule. Effective November 16, 2023. Retrieved from 2023-24184
• Federal Register Rules and Regulations 2025 Physician Fee Schedule Final Rule. Effective December 9, 2024. Retrieved from 2024-25385
• New JZ Claims Modifier for Certain Medicare Part B Drugs. Effective date January 1, 2023. Retrieved from MM13056-MLN Matters
• JW Modifier and JZ Modifier Policy Frequently Asked Questions. Effective date January 1, 2023. Retrieved from JW Modifier FAQs
• JW Modifier and JZ Modifier Policy HCPCS Codes. Effective date January 1, 2023. Retrieved from JW and JZ Modifier HCPCS Codes
• BOTOX (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use. Effective August 22, 2022. Retrieved from U.S. Food and Drug Administration Novita’s Botox FDA Label
• BOTOX (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use. Revised August 22, 2022. Retrieved from U.S. Food and Drug Administration First Coast Service Options Botox FDA Label

Last Updated Oct 21, 2025