CurrentEmblemHealthPolicy AHS-G2130

ST2 Assay for Chronic Heart Failure - Lab Benefit Program (LBM)

Defines coverage and reimbursement stance for the Presage® ST2 (sST2) assay when used in patients with chronic heart failure and related indications under EmblemHealth's Lab Benefit Program.

Policy Summary

PayerEmblemHealth

PolicyST2 Assay for Chronic Heart Failure - Lab Benefit Program (LBM)

Policy CodePolicy AHS-G2130

Change TypeArchived / Reformatted

Effective DateMar 1, 2023

Next Review Date

Key ActionThe Presage® ST2 Assay to evaluate prognosis or to guide management of chronic heart failure does not meet coverage criteria.

SourceLink

POLICY UPDATE CHANGES

Policy Archived effective 11/13/2023; replaced with policy AHS-G2150 Biomarkers for Myocardial Infarction and Chronic Heart Failure.

Reformatted and reorganized policy, transferred content to new template with new Reimbursement Policy Number.

3explicit non-covered use statements

2011FDA-approved year

1100analytic dataset

11/13/2023policy archive date

Coverage Determinations

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Non-covered Indications

The following uses do not meet coverage criteria due to insufficient evidence of required benefit for diagnosis or management:

ALL of the following

The use of the Presage® ST2 Assay to evaluate the prognosis of patients diagnosed with chronic heart failure DOES NOT MEET COVERAGE CRITERIA.
The 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.
The use of the Presage® ST2 Assay in the post-cardiac transplantation period, including predicting prognosis and predicting acute cellular rejection, DOES NOT MEET COVERAGE CRITERIA.

ST2 assay reimbursement notes

Reimbursement policy references and coding for the ST2 assay under the Lab Benefit Program; policy archival/replacement noted.

ALL of the following

Procedure code 83006 is the referenced CPT for the ST2 assay (Growth stimulation expressed gene 2; ST2, Interleukin 1 receptor like-1).
The Presage® ST2 Assay kit received FDA 510(k) marketing clearance in December 2011 and is described as an FDA-cleared microplate assay; other research ELISAs (MBL ST2 ELISA and Human ST2/IL-1 R4 DuoSet) are not FDA-cleared and are not considered in this policy.
If conflict exists with applicable government policy (LCD/NCD/state Medicaid), government policy prevails for determinations.
Policy archived effective 11/13/2023 and replaced with policy AHS-G2150; prior reformatting and transfer to a new template are documented.

Billing and Coding

Applicable coding section referencemixed

No codes listed

ST2 assay procedure codeCPTCovered

83006

Growth stimulation expressed gene 2 (ST2, Interleukin 1 receptor like-1)

Study cutoffs referenced — example cutoffs and tertiles reported in studies

Example study tertile cutoffST2 tertile >36.3 ng/mL (highest tertile vs ≤22.3 ng/mL) reported by Ky et al. (2011)

Example study single‑cutoff (Hou et al., 2020)Best predictive cutoff identified at 43.42671 ng/mL (AUC 0.72; sensitivity 0.69; specificity 0.69)

Example threshold with mortality associationAll‑cause mortality increased significantly above ~34.99 ng/mL in Hou et al. (2020)

Reported study cutoff rangeStudy cutoffs reported around ~33–43 ng/mL across cited analyses

Provider Actions and Notices

Prior Authorization

Regulatory conflict resolution

The government policy (e.g., Local Coverage Determinations, National Coverage Determinations, or applicable state Medicaid coverage) governs if there is any conflict between this policy and a relevant federal or state coverage determination. Providers should follow the applicable LCD/NCD/state Medicaid policy when it differs from this payer policy.

Follow the LCD/NCD/state Medicaid policy when it conflicts with this policy.
Medicare policies: http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx

Denial Risk

Non-covered indication: prognostic use

The use of the Presage® ST2 Assay to evaluate prognosis (predict outcomes) for patients with chronic heart failure is not a covered indication under this policy.

Denial Risk

Non-covered indication: post-transplant use

The use of the Presage® ST2 Assay in the post-cardiac transplantation period, including for predicting prognosis or acute cellular rejection, is not covered under this policy.

Definitions

sST2 / ST2 / ST2L — isoform definitions

sST2Soluble suppression of tumorigenicity 2 (soluble isoform of ST2)

ST2Suppression of tumorigenicity 2 (general receptor name; includes isoforms)

ST2LTransmembrane isoform of ST2 (membrane‑bound receptor variant)

Presage® ST2 Assay — assay description and performance notes

Assay name and manufacturerPresage® ST2 Assay (Critical Diagnostics)

Regulatory statusFDA 510(k) marketing clearance received December 9, 2011; indicated as an aid in assessing prognosis of patients with chronic heart failure

Method and formatIn vitro diagnostic ELISA (enzyme‑linked immunosorbent assay) in a 96‑well microtiter plate format

Analytic measuring range and performanceManufacturer‑reported measuring range ~3.1 ng/mL to 200 ng/mL; analytic data from 1,100 samples report CV <5%, linear curve, r^2 = 0.99

Kit components (summary)Ready‑to‑use coated 96‑well plate, recombinant calibrator, biotinylated detection antibody, tracer, wash and reagents, stop solution, and two control levels

sST2/ST2 — short definition

Short definition — sST2/ST2sST2 (soluble suppression of tumorigenicity‑2), a circulating isoform of ST2 used as a biomarker of myocardial stress and prognosis in heart failure

Biologic roleST2 is the receptor for IL‑33; sST2 can bind IL‑33 and block cardioprotective IL‑33/ST2L signaling, linking sST2 to fibrosis and adverse remodeling

Clinical contextsST2 has been evaluated as an emerging prognostic biomarker in heart failure and may predict mortality and HF events

Policy Change Log

2023-11-13archived/replacedLatest

Policy archived and replaced by policy AHS-G2150 'Biomarkers for Myocardial Infarction and Chronic Heart Failure'.

2022-11reformatted

Policy was reformatted and reorganized and transferred to a new template with a new Reimbursement Policy Number.

2023-08initial_entry_recorded

Company change log includes an entry dated 8/2023 related to the policy's revision history.