01-030 Botulinum Toxins Findings of Medical Review

Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, has conducted post-payment review of claims for Medicare part B billed on dates of service from July 1,2018 through June 30, 2019. Below are the review results:

Project ID Project Title Error Rate
01-030 Botulinum Toxins 66%

Background

Botulinum toxins are potent neuromuscular blocking agents. They 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 are not covered under Medicare.

Reason for Review

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

Common Reasons for Denial

  • Medical Necessity
    • CMS Internet-Only Manuals, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.2 requires the service or item to be reasonable and necessary. The documentation submitted did not support reasonable and necessary criteria was met. Where applicable, the documentation submitted did not support the baseline migraines/headaches criteria and did not support the frequency and duration of headache criteria.
  • No Response to the Documentation Request
    • CMS Internet-Only Manuals, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8 requires providers/suppliers to respond to requests for documentation within 45 calendar days of the additional documentation request. The documentation was not submitted or not submitted timely.
  • Units Billed
    • CMS Internet-Only Manuals, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.4 and Section 3.6.2.5, and Publication 100-04, Medicare Claims Processing Manual Chapter 23 requires the documentation submitted support the number of units 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 Jan 20, 2022