Description
Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, when ordered by a treating physician, and when all of the National Coverage Determination (NCD) requirements are met. The documentation will be reviewed to determine if NGS as a diagnostic laboratory test was medically necessary according to the indications in the NCD.
Affected Code(s)
0111U, 0022U, 0037U
Applicable Policy References
1. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1833(e)- Payment of Benefits
2. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1862(a)(1)(A)- Exclusions from Coverage and Medicare as a Secondary Payer42 CFR §405.929- Post-Payment Review
3. 42 CFR §405.930- Failure to Respond to Additional Documentation Request
4. 42 CFR §405.980- Reopening of Initial Determinations, Redeterminations, Reconsiderations, Decisions, and Reviews, (b)- Timeframes and Requirements for Reopening Initial Determinations and Redeterminations Initiated by a Contractor; and (c)- Timeframes and Requirements for Reopening Initial Determinations and Redeterminations Requested by a Party
5. 42 CFR §405.986- Good Cause for Reopening
6. 42 CFR §410.32-Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions, (a)-Ordering diagnostic tests42 CFR §410.32-Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions, (a)-Ordering diagnostic tests
7. Medicare National Coverage Determination (NCD) Manual, Chapter 1, Part 2- Coverage Determinations, §90.2-Next Generation Sequencing for Patients with Somatic (Acquired) and Germline (Inherited) Cancer; Effective: 01/27/2020; Implementation: 11/13/2020
8. Medicare National Coverage Determination (NCD) Manual, Chapter 1, Part 2- Coverage Determinations, §90.2-Next Generation Sequencing; (for DOS prior to 1/27/2020)
9. Medicare Program Integrity Manual, Chapter 3- Verifying Potential Errors and Taking Corrective Actions, §§3.1- 3.6.6
10. U.S Food & Drug Administration- https://www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools
11. AMA CPT Codebook
12. Annual ICD-10-CM Manual