CurrentKaiser PermanentePolicy N/A

Serum biomarker tests for multiple sclerosis (gMS@Pro EDSS and gMSODx)

Defines Kaiser Permanente Washington coverage stance and clinical review criteria for the gMS@Pro EDSS and gMSODx serum biomarker tests for diagnosing or prognosticating multiple sclerosis; intended for providers requesting these tests for members of Kaiser Foundation Health Plan of Washington and Kaiser Foundation Health Plan of Washington Options, Inc.

Policy Summary

PayerKaiser Permanente

PolicySerum biomarker tests for multiple sclerosis (gMS@Pro EDSS and gMSODx)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionIf requesting these tests, submit the last 6 months of clinical notes from the requesting provider or specialist to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2named tests evaluated

33.7% / 98.5%gMSODx sensitivity / specificity

Not medically necessarycoverage stance

07/03/2012last review

Coverage determination

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Considered Not Medically Necessary

Coverage determination based on Kaiser Permanente Medical Technology Assessment Committee findings

Not medically necessary determination: MTAC concluded evidence is insufficient for diagnostic accuracy, impact on diagnosis, or impact on patient management for the gMSODx and gMS@Pro EDSS tests; therefore use does not meet Kaiser Permanente Medical Technology Assessment Criteria and is considered Not Medically Necessary.

gMSODx reported sensitivity 33.7% and specificity 98.5% in available studies; gMS@Pro EDSS accuracy and clinical utility were judged insufficient by MTAC (see evidence review).

These serum biomarker tests (gMSODx and gMS@Pro EDSS) are listed as Not Medically Necessary for members of Kaiser Foundation Health Plan of Washington and Kaiser Foundation Health Plan of Washington Options, Inc., and are therefore excluded from coverage. There are no specific CPT/HCPCS codes for these services; they are often submitted with unlisted code 84999, which may affect authorization and payment.

The Kaiser Permanente Medical Technology Assessment Committee concluded that use of the gMSODx and gMS@Pro EDSS tests does not meet Medical Technology Assessment Criteria because available evidence is insufficient. For gMSODx, reported diagnostic performance includes a sensitivity of 33.7% and specificity of 98.5%, but evidence is inadequate to show an impact on diagnosis or patient management. For gMS@Pro EDSS, evidence is insufficient to determine test accuracy or clinical utility. Consequently, these tests are considered Not Medically Necessary.

What providers should do

Billing Rule

Authorization / coding note

Prior authorization may be required and claims for these tests are often billed with an unlisted procedure code. If submitting an unlisted code, verify pre-authorization requirements with plan-specific tools before claim submission.

Affected code: unlisted procedure code 84999 (commonly used)
Action: Check Pre-authorization Code Check for plan-specific authorization rules

Documentation Required

Required documentation

Submit the last 6 months of clinical notes from the requesting provider or specialist to support medical necessity. Include any relevant clinical findings, prior testing results, and rationale for ordering the serum biomarker test.

Documentation window: last 6 months of clinical notes
Include: clinical findings, prior test results, and ordering rationale

Denial Risk

Denial risk for non-covered tests

Claims for tests considered not medically necessary are at high risk of denial. Many such claims are submitted with unlisted code 84999 which may lead to automatic denial without supporting documentation or prior authorization.

Denial risk: tests listed as Not Medically Necessary
Billing note: unlisted code 84999 submissions commonly denied without prior auth and supporting docs

Prior Authorization

Provider action

Provider action: verify coverage by checking the member's Evidence of Coverage and contact Kaiser Permanente Member Services for benefit questions as needed. When in doubt about authorization or coding, contact the plan's authorization department prior to performing the service.

Verify: patient’s Evidence of Coverage
Contact: Kaiser Permanente Member Services 1-888-901-4636 (TTY 711), Mon–Fri 8 a.m.–5 p.m.
When uncertain: contact plan authorization department before ordering the test

Clinical background

Multiple sclerosis (MS) is a chronic central nervous system disease with heterogeneous clinical presentation. Diagnosis typically integrates clinical, radiologic, and laboratory findings (for example, using the revised McDonald criteria), and may be delayed because manifestations can be variable. Glycominds’ blood-based assays (gMSODx and gMS@Pro EDSS) aim to detect IgM antibodies against specific alpha-glucose antigens to support diagnostic or prognostic decisions, but the biological basis and clinical utility of these biomarkers remain uncertain.

Test definitions

gMSODx test definition

Test typeBlood-based assay detecting IgM antibodies against an alpha-glucose antigen (GAGA4)

Intended useIntended to identify patients with a high probability of having multiple sclerosis as part of the diagnostic work-up

Reported resultsReported as negative, positive, or high positive

AdvantagesMinimally invasive; blood samples are easy to obtain

LimitationsBiologic basis of the biomarker is unclear; results may be affected by systemic events such as viral infections

gMS@Pro EDSS test definition

Test typeBlood-based assay detecting IgM antibodies against multiple alpha-glucose antigens (GAGA2, GAGA3, GAGA4, GAGA6)

Intended useIntended to identify patients at high risk for rapid disability progression (as measured by EDSS) in early or relapsing-remitting MS

Reported resultsReported as negative or positive

Target populationPatients at their first episode and patients with relapsing-remitting MS during their first decade of disease

LimitationsBiologic basis of the biomarkers is unclear; biomarkers may be affected by systemic events such as viral infections