0204-Vagus Nerve Stimulation: Medical Necessity and Documentation Requirements

Dynamic List Information
Dynamic List Data
Issue Name
0204-Vagus Nerve Stimulation: Medical Necessity and Documentation Requirements
Review Type
Complex
Provider Type
Ambulatory Surgical Center (ASC); Outpatient Hospital; Professional Services
MAC Jurisdiction
All A/B MACs
Date
2021-02-02
RAC Type
Approved

Description

Vagus Nerve Stimulation (VNS) is reasonable and necessary for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed. VNS is not reasonable and necessary for all other types of seizure disorders which are medically refractory and for whom surgery is not recommended or for whom surgery has failed.
VNS is reasonable and necessary for treatment-resistant depression through Coverage with Evidence Development (CED). VNS for treatment of resistant depression is non-covered when furnished outside of a CMS-approved CED study.  Medical documentation will be reviewed to determine if the vagus nerve stimulator meets Medicare coverage criteria and/or is reasonable and necessary.

Affected Code(s)

64568, 95976, 95977

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 Payer
3.    42 CFR §405.929- Post-Payment Review
4.    42 CFR §405.930- Failure to Respond to Additional Documentation Request
5.    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
6.    42 CFR §405.986- Good Cause for Reopening  
7.    Medicare National Coverage Determination (NCD) Manual, Chapter 1-Coverage Determinations, §160.18- Vagus Nerve Stimulation (VNS)
8.    Medicare Program Integrity Manual, Chapter 3- Verifying Potential Errors and Taking Corrective Actions, §§3.1- 3.6.6
9.    Medicare Claims Processing Manual, Chapter 32- Billing Requirements for Special Services, §200- Billing Requirements for Vagus Nerve Stimulation (VNS)
10.    Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD) https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/VNS
11.    AMA CPT Codebook