01-027 Specimen Validity Part 2 Notification of Medical Review

 Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare and Medicaid Services (CMS), is conducting post-payment review of Part B claims for Medicare specimen services 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

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 medical reasonable and necessary. Medicare does not pay for separately billed specimen validity tests when billed with associated urine drug tests. Noridian will complete medical record review on claims in accordance with applicable statutory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

POS CPT
  • 11: Office
  • 81: Independent Laboratory
  • 81000: Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non-automated, with microscopy
  • 81001: Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; automated, with microscopy
  • 81002: Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non-automated, without microscopy
  • 81003: Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; automated, without microscopy
  • 81005: Urinalysis; qualitative or semiquantitative, except immunoassays
  • 82570: Creatinine; other source
  • 84311: Spectrophotometry, analyte not elsewhere specified
  • 83986: pH; body fluid, not otherwise specified

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. Treating physician order or documentation to support the intent to order for the laboratory test billed
  2. Laboratory reports/results for all services billed
  3. Relevant and/or current records from physician’s/practitioner’s office, e.g., office notes, history and physical, labs, etc. as supporting documentation of medical necessity for service that was provided by laboratory provider, if applicable
  4. Medical documentation to support the treating physician used the results in the management of the beneficiary’s specific medical condition
  5. Advance Beneficiary Notice of Noncoverage (ABN), if applicable
  6. Valid electronic and handwritten physician and/or clinician signatures
  7. Signature logs and signature attestation statement should be submitted when physician and/or clinician signatures are illegible

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 A55001. 2018 Controlled Substance Monitoring and Drugs of Abuse Coding and Billing Guidelines. Effective 06/28/2016-present
  • Local Coverage Article A55030. 2018 Controlled Substance Monitoring and Drugs of Abuse Coding and Billing Guidelines. Effective 06/28/2016-present
  • Local Coverage Article A54314. Controlled Substance Monitoring and Drugs of Abuse Coding and Billing Guidelines. Effective 10/01/2015-present
  • Local Coverage Article 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 Dec 19, 2019