01-049 Vitamin D Testing Notification of Medical Review

Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, is conducting post-payment review of a sample of Part B claims for Medicare Vitamin D laboratory test services billed on dates of service from January 1, 2019 through December 31, 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

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 billed properly.

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 will conduct medical record reviews in accordance with applicable statutory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

POS CPT
  • 11: Office
  • 81: Independent Laboratory
82306: Vitamin D 25-hydroxy

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. PLEASE NOTE: It is the responsibility of the lab to obtain all documentation from the ordering/referring provider to ensure medical necessity criteria have been met
  2. Medical record documentation to support medical necessity of the Vitamin D laboratory test under review
  3. Previous Vitamin D laboratory test results within the past 12 months
  4. Documentation to support Local Coverage Determination (LCD) and Policy Article (PA) requirements
  5. Medical record documentation to support the dates of service billed on the claim
  6. Physician/Non Physician (NPP) order or evidence of intent to order
  7. Diagnostic tests, radiological reports, lab results, pathology reports, and other pertinent test results and interpretations
  8. Documentation that supports the clinical significance of the test performed
  9. Practitioner, nurse, and ancillary progress notes
  10. Documentation supporting the diagnosis code(s) required for the item(s) billed
  11. Signature log or signature attestation for any missing or illegible signatures within the medical record (all personnel providing services)
  12. 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 and dated by the physician
  13. Advance Beneficiary Notice
  14. Any other supporting documentation
  15. 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

References/Resources

  • Social Security Act (SSA) Title XVIII, Section 1815(a). Providers must furnish information.
  • SSA, Title XVIII, Section 1833(e). Payment of Benefits.
  • SSA, Title XVII, Section 1842(p)(4). Provisions Relating to the Administration of Part B.
  • SSA, Title XVII, Section 1861. Part E – Miscellaneous Provisions.
  • SSA, Title XVIII, Section 1862(a)(1)(a). Exclusion from Coverage and Medicare as a Secondary Payer.
  • SSA, Title XVIII, Section 1862(a)(7). Routine Physical Examinations.
  • SSA, Title XVIII, Section 1879 (a)(1). Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed.
  • SSA, Title XVIII, Section 1893 (f)(7)(A)(B)(i-iv). Medicare Integrity Program.
  • 42 Code of Federal Regulations (C.F.R.), Section 410.32. Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and Other Diagnostic Tests: Conditions.
  • 42 C.F.R., Section 424.5. Basic Conditions.
  • 42 C.F.R., Section 424.535. Revocation of enrollment in the Medicare Program.
  • CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 6, Section 20.4. Outpatient Diagnostic Services.
  • CMS IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80.1. Clinical Laboratory Services.
  • CMS IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80.6. Requirements for Ordering and Following Orders for Diagnostic Tests.
  • CMS IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 16. General Exclusions from Coverage.
  • CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 16. Laboratory Services.
  • CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 30, Section 30.2. Healthcare Provider or Supplier Knowledge and Liability.
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.3. Third-party Additional Documentation Request.
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Sections 3.2.3.7. Special Provisions for Lab Additional Documentation Requests.
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8. No response of Insufficient Response to Additional Documentation Requests.
  • 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 3.6.2.1. Coverage Determinations.
  • 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 6, Section 3.6.9. Medical Review of Diagnostic Tests.
  • 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) L36219 Noncovered Services. Effective October 1, 2015.
  • LCD L36692 Vitamin D Assay Testing. Effective February 3, 2017.
  • LCD L37535 Vitamin D Assay Testing. Effective April 1, 2018.
  • Local Coverage Article (LCA) A57718 Billing and Coding: Vitamin D Assay Testing. Effective December 1, 2019.
  • LCA A57736 Billing and Coding: Vitamin D Assay Testing. Effective November 14, 2019.
  • Medicare Learning Network ICN MLN909221 December 2020. Complying with Documentation Requirements for Laboratory Services.

Last Updated Jul 7, 2021