CurrentKaiser PermanentePolicy MPC

Kaiser Foundation Health Plan of Washington Clinical Review Criteria - Vectra DA Test for Rheumatoid Arthritis

Policy Summary

PayerKaiser Permanente

PolicyKaiser Foundation Health Plan of Washington Clinical Review Criteria - Vectra DA Test for Rheumatoid Arthritis

Policy CodePolicy MPC

Change TypeClarified; Revised

Effective DateJan 6, 2016

Next Review Date

Key ActionIf requesting the Vectra DA test, send the last 6 months of clinical notes from the requesting provider and/or consulting specialist to support medical necessity.

POLICY UPDATE CHANGES

MTAC determined on 12/21/2015 that Vectra DA does not meet Kaiser Permanente Technology Assessment Criteria due to insufficient evidence.

Policy reviewed 01/06/2016 with last revised date 01/06/2016 (MPC).

1CPT code listed

InsufficientCoverage conclusion for Non-Medicare

Follows CMS/LCDMedicare stance

Coverage Summary

Defines Kaiser Permanente Washington clinical review criteria and coverage stance for the Vectra DA multibiomarker disease activity (MBDA) blood test for adult rheumatoid arthritis patients; Coverage stance: mixed (Medicare: follows applicable CMS/LCD guidance; Non-Medicare: Not medically necessary due to insufficient evidence). Effective date: 2016-01-06. Last review: 2016-01-06. Policy number: MPC.

Policy Metadata

PolicyVectra DA Test (MBDA) for Rheumatoid Arthritis

PayerKaiser Permanente

Policy NumberMPC

Effective Date2016-01-06

Last Review2016-01-06

Coverage Stancemixed

SubjectVectra DA Test (MBDA) for Rheumatoid Arthritis

Scope SummaryDefines Kaiser Permanente Washington clinical review criteria and coverage stance for the Vectra DA multibiomarker disease activity (MBDA) blood test for adult rheumatoid arthritis patients; describes evidence assessment, documentation requested, and applicable CPT code(s).

Medical-Necessity / Coverage Determinations

Medicare Members Coverage Determination

Medicare coverage follows applicable policy statements when criteria are met:

Coverage follows CMS/NCD/LCD guidance where applicable; document indicates 'CMS Coverage Manuals, Policy = None. NCD = None. LCD = None.' and references an LCD article retirement note.

Continue to use LCD A54505 for determining medical necessity per the document's LCD retirement note.

Non-Medicare Members Coverage Determination

Coverage position for non-Medicare members:

Vectra DA (MBDA) test is considered NOT MEDICALLY NECESSARY for Non-Medicare members due to insufficient evidence that the service is as safe or provides better long-term outcomes than standard therapies.

If requesting this service, send the last 6 months of clinical notes from the requesting provider and/or consulting specialist to support medical necessity.

Supportive clinical documentation required per policy.

Medical Technology Assessment Committee (MTAC) Conclusion

MTAC 12/21/2015 evidence conclusion:

There is insufficient evidence to determine whether MBDA (Vectra DA) is as good as or better than established indices for measuring RA disease activity.

Published studies show moderate correlation between Vectra DA and DAS28-CRP for classifying low vs moderate-high disease activity, but insufficient evidence for clinical validity and ability to predict outcomes or impact management.

Use of Vectra DA does not meet Kaiser Permanente Technology Assessment Criteria for monitoring RA disease activity.

MTAC concluded on 12/21/2015 that Vectra DA does not meet the criteria due to insufficient evidence.

Provider Actions & Requirements

Documentation Required

Supportive clinical documentation required

If requesting the Vectra DA test, send the last 6 months of clinical notes from the requesting provider and/or consulting specialist to support medical necessity.

81490

Prior Authorization

Verify preauthorization requirements

To verify authorization requirements for specific codes by plan type, use the Pre-authorization Code Check.

81490

Background & Evidence Summary

Vectra DA is a commercial blood test that measures the serum concentrations of 12 biomarkers and combines them into an algorithm to produce a multibiomarker disease activity (MBDA) score intended to aid assessment of rheumatoid arthritis (RA) disease activity in adults when used alongside standard clinical assessment. Kaiser review (MTAC 12/21/2015) found evidence on analytic validity and several clinical validity studies, reporting a moderate correlation with DAS28-CRP for classifying low versus moderate-high disease activity. However, the Committee concluded there is insufficient evidence for clinical validity regarding prediction of outcomes and insufficient evidence that Vectra DA results impact management; therefore it does not meet Kaiser Permanente Technology Assessment Criteria and is considered not medically necessary for non-Medicare members.

Evidence Highlights

MTAC Evidence ConclusionThere is insufficient evidence that MBDA (Vectra DA) is as good as or better than established indices; published studies show moderate correlation with DAS28-CRP but insufficient evidence for clinical validity or impact on management (MTAC 12/21/2015).

Studies citedBakker et al. 2012; Curtis et al. 2012

DefinitionCommercial blood test measuring 12 biomarkers and producing a multibiomarker disease activity score for rheumatoid arthritis; not validated to diagnose RA but as an adjunct to clinical assessment.

Name	Number	Type	Effective Date	Notes
Noridian retired: Billing and Coding: MolDX	A54505 (referenced)	LCD	2021-09-17	Referenced/retired per brief; continue to use LCD A54505 for determining medical necessity

Revision History

12/21/2015MTAC determination

MTAC determined Vectra DA does not meet criteria; insufficient evidence

01/06/2016policy review/revision

Policy reviewed 01/06/2016 with Date Last Revised = 01/06/2016 (MPC)

07/09/2019revision history noteLatest

Revision history entry listed through 07/09/2019; clinical policy statement remained that evidence is insufficient

Policy Summary

PayerKaiser Permanente

PolicyKaiser Foundation Health Plan of Washington Clinical Review Criteria - Vectra DA Test for Rheumatoid Arthritis

Policy CodePolicy MPC

Change TypeClarified; Revised

Effective DateJan 6, 2016

Next Review Date

Key ActionIf requesting the Vectra DA test, send the last 6 months of clinical notes from the requesting provider and/or consulting specialist to support medical necessity.

On This Page

OpenPayer

Kaiser Foundation Health Plan of Washington Clinical Review Criteria - Vectra DA Test for Rheumatoid Arthritis

Coverage Summary

Medical-Necessity / Coverage Determinations

Provider Actions & Requirements

Coding

Background & Evidence Summary

Medicare Determinations

Revision History