01-030 Botulinum Toxins Notification of Medical Review

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 claims for Medicare Part B botulinum toxins billed on dates of service from July 1, 2018 through June 30, 2019. 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 toxins are potent neuromuscular blocking agents that are useful in treating various focal muscle spastic disorders and excessive muscle contractions, such as dystonias, spasms, and twitches. Botulinum toxins are also used to treat headache/migraine when qualifying criteria are met. Botulinum toxins used for the treatment of wrinkles are considered to be cosmetic and is not covered under Medicare.

Reason for Review

CMS tasked Noridian, as the SMRC, to perform data analysis and conduct medical review. Noridian will complete medical record review on claims in accordance with applicable statutory, regulatory and sub-regulatory guidance.

Claim Sample Detail

POS HCPCS
  • 11: Office
  • J0585: Injection, onabotulinumtoxina, 1 unit
  • J0586: Injection, abobotulinumtoxina, 5 units
  • J0587: Injection, rimabotulinumtoxinb, 100 units
  • J0588: Injection, incobotulinumtoxina, 1 unit

Access related project details below.

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. Documentation requested has been made specific to assist the provider in collecting and submitting pertinent information to decrease provider burden.

  1. Physician orders to support service(s) being billed
  2. All pertinent medical record documentation to support the beneficiary’s medical condition and procedure for the billed service(s), including but not limited to:
    1. History and Physical
    2. Progress notes
    3. Consultations
    4. Procedure notes
  3. Legible handwritten Physician and/or Clinician signatures
    1. Signature Attestation and Signature Log should be submitted when Physician or Clinician signatures are illegible
  4. Valid electronic Physician and/or Clinician signatures
  5. Advanced Beneficiary Notice of Noncoverage (ABN), if applicable
  6. Any and all other documentation to support the service(s) billed

References/Resources

  • Social Security Act (SSA), Title XVIII, §1833(e). Payment of Benefits
  • SSA, Title XVII, §1861 (t)(1). Miscellaneous Provisions
  • SSA, Title XVIII, §1862(a)(1)(A). Exclusions from Coverage and Medicare as Secondary Payer
  • SSA, Title XVIII, §1862(a)(10). Exclusions from Coverage and Medicare as Secondary Payer
  • SSA, Title XVIII, §1879(a)(1). Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
  • SSA, Title XVII, §1893(f)(7)(A)(B)(i-iv), (h)(4)(B). Medicare Integrity Program
  • 42 Code of Federal Regulations (C.F.R.) 410.29. Limitations on drugs and biologicals
  • 42 C.F.R. 411.404. Criteria for determining that a beneficiary knew that services were excluded from coverage as custodial care or as not reasonable and necessary
  • 42 C.F.R. 424.5(a)(6). Basic Conditions
  • CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50. Drugs and Biologicals
  • CMS IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 16, Section 20. Services Not Reasonable and Necessary
  • CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40. Discarded Drugs and Biologicals
  • CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter Fee Schedule Administration and Coding Requirements
  • CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 30, Section 50. Advance Beneficiary Notice of Noncoverage (ABN)
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.3.2.4. Signature Requirements
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.2. Reasonable and Necessary Criteria
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4. Reasonable and Necessary Provisions in LCDs
  • Local Coverage Determination (LCD) L33274. Botulinum Toxins. Effective October 1, 2015-present
  • LCD L33646. Botulinum Toxins. Effective October 1, 2015-present
  • LCD L33949. Botulinum Toxins. Effective October 1, 2015-present
  • LCD L34635. Botulinum Toxins Type A & Type B. Effective October 1, 2015-present
  • LCD L35170. Botulinum Toxins Types A and B Policy. Effective October 1, 2015-present
  • LCD L35172. Botulinum Toxins Types A and B. Effective October 1, 2015-present
  • Policy Article A52381. Botulinum Toxins – Supplemental Instructions Article. Effective October 1, 2015-April 3, 2019
  • Policy Article A52848. Billing and Coding: Botulinum Toxins. Effective October 1, 2015-present
  • Policy Article A56472. Billing and Coding: Botulinum Toxins. Effective October 1, 2018-present
  • Policy Article A57715. Billing and Coding: Botulinum Toxins. Effective October 3, 2018-present

Last Updated Apr 2, 2020