Currentblue cross blue shield - tennesseePolicy N/A

ST2 (Presage®) assay for chronic heart failure

Defines coverage stance for use of the Presage® ST2 assay (soluble ST2) in prognosis, management, and post-transplant monitoring of patients with chronic heart failure for Blue Cross Blue Shield - Tennessee members.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyST2 (Presage®) assay for chronic heart failure

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionDo not submit prior authorization requests for use of the Presage® ST2 Assay to evaluate prognosis, guide management of chronic heart failure, or monitor post-cardiac transplant patients because these uses do not meet coverage criteria and are expected to be denied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Not covered uses

510(k)FDA status

2011FDA clearance year

1100Analytical samples

7/1/2023Effective

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Coverage Criteria — Presage® ST2 Assay

Not Medically Necessary / Not Covered Uses

The policy explicitly states the following uses do not meet coverage criteria:

Not covered uses: 1) Use of the Presage® ST2 Assay to evaluate the prognosis of patients diagnosed with chronic heart failure DOES NOT MEET COVERAGE CRITERIA.

Not covered uses: 2) Use of the Presage® ST2 Assay to guide management (pharmacological, device-based, exercise, etc.) of patients diagnosed with chronic heart failure DOES NOT MEET COVERAGE CRITERIA.

Not covered uses: 3) Use of the Presage® ST2 Assay in the post cardiac transplantation period, including but not limited to predicting prognosis and predicting acute cellular rejection, DOES NOT MEET COVERAGE CRITERIA.

The policy excludes use of the Presage® ST2 Assay in the post‑cardiac transplantation period. Specifically, use of the assay to predict prognosis or to predict acute cellular rejection after cardiac transplantation does not meet coverage criteria.

Results generated by other research or non‑cleared sST2 assays are not considered equivalent to the Presage® ST2 Assay. The policy explicitly notes that the MBL ST2 ELISA kit and the Human ST2/IL‑1 R4 DuoSet® use different standards, antibodies, reagents, and buffers, their results are not comparable, and neither has received FDA marketing approval; therefore those assays are not considered in this policy.

Use of the Presage® ST2 Assay to evaluate prognosis of patients diagnosed with chronic heart failure or to guide management (pharmacologic, device‑based, exercise, etc.) of patients with chronic heart failure does not meet coverage criteria.

Provider Actions, Prior Authorization, and Regulatory Notes

Denial Risk

Coverage Denial Risk for Presage® ST2 Uses

The Presage® ST2 Assay is not covered for use in prognosis, to guide management, or for post-cardiac transplant prediction/monitoring. Requests for coverage of the assay for these purposes are expected to be denied.

Presage® ST2 for prognosis of chronic heart failure — NOT COVERED
Presage® ST2 to guide pharmacologic/device/exercise management — NOT COVERED
Presage® ST2 for post–cardiac transplant prognosis or prediction of acute cellular rejection — NOT COVERED

Note

Government Policy Precedence

If there is any conflict between this policy and applicable government coverage (for example, Medicare LCDs or NCDs, or state Medicaid determinations), the government policy prevails and will be used to make coverage determinations.

Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs) take precedence over this policy when applicable
State Medicaid policies supersede when applicable

Prior Authorization

Benefit Verification and Regulatory Precedence

Application of coverage depends on the member's specific benefits at the time of request; benefit verification is required prior to testing. Government policies (e.g., LCD/NCD) may override this policy for affected members.

Verify member benefits and eligibility before ordering the Presage® ST2 Assay
If the member is covered by Medicare/Medicaid, check applicable LCDs/NCDs or state Medicaid rules

Documentation Required

Lab Test Validation and Kit Details

Laboratories performing ST2 testing must follow CLIA requirements for high-complexity testing when using laboratory-developed tests (LDTs). Note that the Presage® ST2 Assay kit received FDA 510(k) clearance; other ST2 research kits do not have FDA clearance and are not considered equivalent.

LDTs are regulated under CLIA '88 as high-complexity tests and require appropriate validation and documentation
Presage® ST2 Assay kit: FDA 510(k) cleared (December 2011) — supplied as a 96-well microplate kit with controls and reagents
Other ST2 assays (e.g., MBL ST2 ELISA, Human ST2/IL-1 R4 DuoSet®) use different reagents/standards and lack FDA marketing clearance — results are not comparable and are not considered in this policy

Step Therapy

No step therapy requirements apply to the Presage® ST2 Assay; there are no step edits or prerequisite therapies/tests specified in this policy.

No step therapy instructions provided

Background and Rationale

Heart failure is a clinical syndrome caused by structural or functional cardiac abnormalities that impair the heart's ability to fill with or eject blood. Soluble ST2 (sST2) is a circulating biomarker—suppression of tumorigenicity 2—that reflects myocardial stress, inflammation, and fibrosis and has been evaluated as an adjunct prognostic marker in heart failure. The Presage® ST2 Assay is an immunoassay kit (FDA 510(k) cleared in 2011) that quantitatively measures sST2 and is intended to be used with clinical evaluation as an aid in assessing prognosis of patients with chronic heart failure; however, the policy finds that using the assay to determine prognosis or to direct patient management is not supported for coverage.

Definitions and Test Description

ST2 / sST2

TermSuppression of tumorigenicity 2 (ST2)

Alternate namesST2 (soluble ST2)

CategoryBiomarker used in heart failure prognostication

NT-proBNP

TermN-terminal pro hormone brain natriuretic peptide (NT-proBNP)

CategoryCardiac biomarker used in diagnosis and risk stratification of heart failure

Presage® ST2 Assay

Regulatory statusFDA 510(k) marketing clearance (December 2011)

Intended useMicroplate immunoassay kit to be used with clinical evaluation as an aid in assessing prognosis of chronic heart failure

Kit components96-well coated microtiter plate, recombinant human sST2 calibrator, biotinylated anti-ST2 antibody, diluents, tracer, wash, TMB reagent, stop solution, high/low controls