Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the CMS, is conducting post-payment review of claims for Medicare Genetic Testing Current Procedural Terminology (CPT) code, 81408, billed on dates of service from January 1, 2021, through December 31, 2021. 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

Genetic testing uses molecular pathology technology that identifies changes in genes, chromosomes, or proteins. The gene specific coding system was updated after January 1, 2013, to include the test, analytic services and processes performed to reduce or eliminate stacking of codes in billing. This resulted in five subgroups of Current Procedural Terminology (CPT) codes which includes Tier 1-Analyte Specific code; a single test or procedure corresponds to a single CPT code and Tier 2-Rare disease and low volume molecular pathology services. Tier 2 includes CPT code 81408, “molecular pathology procedure, Level 9.” An example of a level 9 molecular pathology procedure includes analysis of >50 exons in a single gene by DNA sequence analysis. An Exon is a segment of DNA or RNA containing information coding for a protein or peptide sequence.

The Office of Inspector General (OIG), published a report (A-09-22-03010) titled “CMS’s Oversight of Medicare Payments for The Highest Paid Molecular Pathology Genetic Test Was Not Adequate to Reduce the Risk of Up To $888 Million In Improper Payments.” The OIG analyzed 450,000 Medicare Part B claims billed with CPT code 81408. Based on the results, up to $888.2 million Medicare payments were at risk for improper payment.

Reason for Review

The SMRC is tasked to perform data analysis and conduct a coding review for claims billed with the Genetic Testing code 81408 with DOS January 1, 2021, through December 31, 2021.

The SMRC will conduct medical record reviews in accordance with applicable waivers/flexibilities/statutory, regulatory, sub-regulatory, and coding guidance.

Claim Sample Detail

Access related project details below.

• Documentation Requirements
• References

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.

Providers/suppliers are requested to submit each of the Documentation Requirements outlined below, if and as applicable to the claim on review.

1. Complete description of the test performed
2. Medical record documentation to support the dates of service billed on the claim
3. Documentation to support the code as billed
4. Beneficiary name and date of service on all documentation
5. Signature and credentials of all personnel providing services. Include a signature log or signature attestation for any missing or illegible signatures within the medical record
6. 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 by the physician
7. Any other supporting/pertinent documentation
8. Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC)
9. List of all non-standard abbreviations or acronyms used, including definitions
10. 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
11. PLEASE NOTE: It is the responsibility of the supplier or provider to obtain all documentation from the ordering/referring provider to ensure medical necessity criteria have been met

References

Social Security Act (SSA), Title XVIII

• § 1815(a) Payment to Providers of Services
• § 1833(e) Payment of Benefits
• § 1861(s)(1) Physician Services
• § 1861(s)(3) Medical and Other Health Services
• § 1862(a)(1)(A) Exclusions from Coverage and Medicare as Secondary Payer
• § 1879(a)(1) Limitation on Liability of Beneficiary where Medicare Claims are Disallowed

42 Code of Federal Regulations (CFR)

• § 411.15(k)(1) Any services that are not reasonable and necessary
• § 414.502(1) Definitions
• § 424.5(a)(6) Conditions for Medicare Payment-Basic Conditions, Sufficient Information

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

• Ch. 16, General Exclusion from Coverage

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

• Ch. 1, General Billing Requirements
• Ch. 12 § 60 Payment for Pathology Services
• Ch. 23 § 20.9 National Correct Coding Initiative (NCCI)
• Ch. 23, § 20.9.1.1 Instructions for Codes with Modifiers (A/B MACs (B) Only)
• Ch. 26, § 10.5 Place of Service Codes (POS) and Definitions

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

• Ch. 3, Verifying Potential Errors and Taking Corrective Actions
• Ch. 3, § 3.2.3.8 Requested Records Not Received
• Ch. 3, § 3.3.1.1.H Review Timeliness Requirements
• Ch. 3, § 3.3.2.4 Signature requirements
• Ch. 3 § 3.6.2.4 Coding Determinations

Local Coverage Article (LCA)

• A58918 Billing and Coding: Molecular Pathology and Genetic Testing
• A58917 Billing and Coding: Molecular Pathology and Genetic Testing
• A58812 Billing and Coding: Pharmacogenomics Testing
• A58801 Billing and Coding: Pharmacogenomics Testing
• A57451 Billing and Coding: Molecular Pathology Procedures

Other

• National Correct Coding Initiative (NCCI) Policy Manual, Ch. 10 § F Molecular Pathology
• Office of Inspector General (OIG) CMS’s Oversight of Medicare Payments for the Highest Paid Molecular Pathology Genetic Test Was Not Adequate To Reduce the Risk of up to $888 Million in Improper Payments . Report Number A-09-22-03010, June 21, 2023

Last Updated Oct 6, 2023