01-049 Vitamin D Testing 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 vitamin D laboratory test services billed on dates of service from January 1, 2019, through December 31, 2019. Below are the review results:

Project ID Project Title Error Rate
01-049 Vitamin D Testing 96%

Background

Title XVIII of Social Security Act, Section 1861 Act provides for payment of clinical laboratory services under Medicare Part B. Vitamin D lab assay testing is only reimbursable under Medicare when it meets certain conditions and not as a routine screening according to 42 CFR 410.32(a). CMS tasked the SMRC to review a sample of vitamin D claims to determine if claims were properly billed.

Reason for Review

CMS tasked Noridian, as the SMRC, to complete data analysis and conduct medical review on vitamin D assay testing, CPT Code 82306, claims to determine if vitamin D testing billed was reasonable and necessary. The SMRC conducted medical record reviews in accordance with applicable statutory, regulatory, and sub-regulatory guidance.

Common Reasons for Denial

  • Documentation did not support medical necessity for the service billed
    • Vitamin D lab assay testing is only reimbursable under Medicare when it meets certain conditions and not as a routine screening according to 42 CFR 410.32(a). The Medicare Claims Processing Manual, Chapter 16 indicates tests that are performed in the absence of signs, symptoms, complaints, personal history of disease, or injury are considered screening and are generally not covered. Documentation did not support medical necessity for vitamin D assay testing.
  • Documentation did not support the medical necessity for the number of services billed
    • Local Coverage Determination (LCD) L37535 Vitamin D Assay Testing requires documentation in the patient’s medical record for repeat testing to clearly indicate the necessity of the test if the previous test result was in normal range. LCD L36692 Vitamin D Assay Testing also requires documentation to clearly indicate the necessity for the initial test and any and all repeat testing and frequency of testing.
  • No order or documentation to support intent to order
    • 42 CFR 410.32(a) requires a clinical diagnostic test be ordered by the physician who is treating the patient for a specific medical problem and uses the results in the management of the beneficiary’s specific problem.

References/Resources

Social Security Act (SSA), Title XVIII

  • 1815(a) Payment to Providers of Services
  • 1833(e) Payment of Benefits
  • 1842(p)(4) Provisions Relating to the Administration of Part B
  • 1861 Part E – Miscellaneous Provisions
  • 1862(a)(1)(a) Exclusion from Coverage and Medicare as a Secondary Payer
  • 1862(a)(7) Routine Physical Examinations
  • 1879(a)(1) Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
  • 1893(f)(7)(A)(B) (i-iv) Medicare Integrity Program

Title 42 of the Code of Federal Regulations (CFR)

  • 410.32 Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and Other Diagnostic Tests: Conditions
  • 424.5 Basic Conditions

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

  • Chapter (Ch.) 6, 20.4 Outpatient Diagnostic Services
  • 15, § 80.1 Clinical Laboratory Services
  • 15, § 80.6 Requirements for Ordering and Following Orders for Diagnostic Tests
  • 16 General Exclusions from Coverage

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

  • 16 Laboratory Services
  • 30, § 30.2 Healthcare Provider or Supplier Knowledge and Liability

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

  • 3 § 3.2.3.3 Third-party Additional Documentation Request
  • 3 § 3.2.3.7 Special Provisions for Lab Additional Documentation Requests
  • 3 § 3.2.3.8 No response or Insufficient Response to Additional Documentation Requests
  • 3 § 3.3.2.4 Signature Requirements
  • 3 § 3.6.2.1 Coverage Determinations
  • 3 § 3.6.2.2 Reasonable and Necessary Criteria
  • 6 § 3.6.9 Medical Review of Diagnostic Tests
  • 13 § 13.5.4 Reasonable and Necessary Provisions in LCDs

Local Coverage Determination (LCD)

  • L36219 Noncovered Services
  • L36692 Vitamin D Assay Testing
  • L37535 Vitamin D Assay Testing

Local Coverage Article (LCA)

  • A57718 Billing and Coding: Vitamin D Assay Testing
  • A57736 Billing and Coding: Vitamin D Assay Testing

Other:

  • Medicare Learning Network (MLN) Matters Article, MLN909221 Complying with Documentation Requirements for Laboratory Services

Last Updated Jun 28, 2022