01-027 Specimen Validity Part 2 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 specimen validity testing services billed on dates of service from July 1, 2018 through June 30, 2019. Below are the review results:

Project ID Project Title Error Rate
01-027 Specimen Validity Part 2 42%

Background

In February 2018, The Office of Inspector General (OIG) from report A-09-16-02034, found that payments made to providers for specimen validity tests did not comply with Medicare billing requirements. Medicare identified claims improperly paid to 4,480 clinical laboratories and physician offices that billed $66.3 million for specimen tests, used to determine the validity of the sample, billed in combination with urine drug tests. The report noted that CMS system edits were not adequate to prevent payment for specimen validity tests billed in combination with urine drug tests. In response to the OIG report, CMS directed the SMRC to perform medical review activities. Based on the project findings, CMS concluded that further medical review activities would be necessary to determine whether claims were paid properly within Medicare requirements.

Reason for Review

CMS tasked Noridian, as the SMRC, to perform medical review to determine if the urine specimen validity testing billed with urine drug tests, were medically reasonable and necessary. Medicare does not pay for separately billed specimen validity tests when billed with associated urine drug tests. Noridian completed medical record review on claims in accordance with applicable statutory, regulatory, and sub-regulatory guidance.

Common Reasons for Denial

  • 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.
  • Incomplete/Insufficient Documentation
    • CMS Internet-Only Manuals, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8, 42 CFR 424.5(a)(6), Social Security Act 1833(e) outlines a service is to be considered reasonable and necessary when it is furnished in accordance with accepted standards of medical practice and sufficient supporting documentation is present within the medical record.

References/Resources

  • Social Security Act (SSA), Title XVIII, §§1833(e). Payment of Benefits
  • SSA, Title XVIII, §§1862(a)(1)(a). Exclusion from Coverage and Medicare as a Secondary Payer.
  • SSA, Title XVIII, §§1879 (a)(1). Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
  • SSA, Title XVIII, §§1893(b). Medicare Integrity Program
  • 42 Code of Federal Regulations (F.R.) §410.32(a). Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and Other Diagnostic Tests: Conditions.
  • 42 C.F.R. §411.15. Particular Services Excluded from Coverage
  • 42 C.F.R. §482.24. Condition of participation: Medical record services
  • CMS Internet Only Manual (IOM), Publication 100-04, Medicare Claims Processing Manual, Chapter 1, Section 120-120.3. Detection of Duplicate Claims
  • CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 12, Section 20.3. Bundled Services/Supplies
  • CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 23. Fee Schedule Administration and Coding Requirements
  • CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Transmittal 3439, Change Request 9502, January 15, 2016. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3439CP.pdf
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 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 or Insufficient Response to Additional Documentation Requests
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.3.2.1.Documents on Which to Base a Determination
  • 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 3, Section 3.6.2.4. Coding Determinations
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.5, A. Distinguishing Between Benefit Category, Statutory Exclusion and Reasonable and Necessary Denials.
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 4, Section 4.2.1. Example of Medicare Fraud
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 4, Section 4.3.Medical Review for Program Integrity Purposes
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 6, Section 6.9. Medical Review of Diagnostic Tests
  • Local Coverage Determination (LCD) L36029. Controlled Substance Monitoring and Drugs of Abuse Testing. Effective 10/05/2015-present
  • LCD L36393. Controlled Substance Monitoring and Drugs of Abuse Testing. Effective 10/11/2015-present
  • LCD L36668. Controlled Substance Monitoring and Drugs of Abuse Testing. Effective 06/28/2016-present
  • LCD L36707. Controlled Substance Monitoring and Drugs of Abuse Testing. Effective 06/28/2016-present
  • LCD L35006. Controlled Substance Monitoring and Drugs of Abuse Testing. Effective 10/01/2015-present
  • LCD L35724. Controlled Substance Monitoring and Drugs of Abuse Testing.Effective 10/01/2015-present
  • LCD L36037. Urine Drug Testing. Effective 12/01/2015-present.
  • Local Coverage Article (LCA) A55001. 2018 Controlled Substance Monitoring and Drugs of Abuse Coding and Billing Guidelines. Effective 06/28/2016-present
  • LCA A55030. 2018 Controlled Substance Monitoring and Drugs of Abuse Coding and Billing Guidelines. Effective 06/28/2016-present
  • LCA A54314. Controlled Substance Monitoring and Drugs of Abuse Coding and Billing Guidelines.Effective 10/01/2015-present
  • LCA A54799. Controlled Substance Monitoring and Drugs of Abuse Coding and Billing Guidelines. Effective 12/24/2015-present
  • National Correct Coding Initiative Policy Manual – Manual for Medicare Services (Coding Policy Manual), revised Jan. 1, 2017, Chapter 10, Section EX-7, E. Drug Testing

Last Updated Oct 7, 2021