CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Home Prothrombin Time (INR) Monitoring

Policy governs coverage and coding for at-home prothrombin time/INR monitoring (using FDA-approved devices) for patients on chronic warfarin therapy, applicable to Medicare Advantage and commercial products under Blue Cross Blue Shield - Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyHome Prothrombin Time (INR) Monitoring

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateJan 1, 2015

Next Review DateN/A

Key ActionDocument face-to-face demonstration and at least one observed blood sample to confirm patient or caregiver competency for home INR testing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

G0248…93793separately reimbursed codes listed

Eff 10/01/2015policy dates

Mechanical valves; AFexample conditions cited

≤1/weekfrequency/billing note

Coverage Criteria for Home INR Monitoring

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Medically necessary coverage criteria

Covered when ALL of the following are met

Eligibility for home INR monitoring: Patient requires continuous anticoagulation for chronic medical conditions (examples include mechanical heart valves and chronic atrial fibrillation).

Policy states 'include, but not limited to' these conditions.

Use of FDA-approved device: Home prothrombin time monitoring must be performed with a U.S. Food and Drug Administration (FDA)-cleared device intended for patient self-testing (examples: CoaguChek XS, ProTime Microcoagulation System, Alere INRatio 2).

Device examples cited in policy; patient self-testing systems cleared by FDA.

Patient training and competency: Patient or caregiver must receive face-to-face demonstration/training (including obtaining at least one blood sample) and documentation that they can perform testing and report results; documentation requirements are described for codes G0248 and 93792.

Documentation of demonstration, sample collection, instruction, and ability to report results is required.

Clinical intent for effectiveness: Patient should be on a stable regimen of warfarin anticoagulation where home self-monitoring is appropriate and expected to improve management by producing INR results comparable to laboratory measures and increasing time in therapeutic range or reducing thromboembolic/hemorrhagic events.

Home monitoring is effective only if patients can generate INR results comparable to laboratory measures.

Billing and Coding

Covered codes — anticoagulation managementCPTCovered

93793

Anticoagulation management for a patient taking warfarin; includes review and interpretation of a new home, office, or lab INR test result, patient instructions, dosage adjustment (as needed), and scheduling of additional test(s) when performed

Covered codes — test materialsHCPCSCovered

G0249

Provision of test materials and equipment for home INR monitoring; includes provision of materials for use in the home and reporting of test results to physician; testing not occurring more frequently than once a week; testing materials, billing units of service include 4 tests

Covered codes — physician managementHCPCSCovered

G0250

Physician review, interpretation, and patient management of home INR testing; testing not occurring more frequently than once a week; testing materials, billing units of service include 4 tests

Testing frequency / billing note

Testing frequency restrictionHome INR testing and related billing units should not occur more frequently than once per week; billing units for test materials include 4 tests.

Applies to codesTesting frequency note specifically applies to G0249 (test materials) and G0250 (physician review/management).

Billing unit detailWhen billing G0249 or G0250, billing units of service are based on groups of 4 tests.

Provider Responsibilities and Billing Notes

Prior Authorization

Prior authorization is not applicable for these services.

Denial Risk

Benefit Variability May Trigger Denial

Benefits and billing depend on the member's specific benefit plan. Verify the member's Benefit Booklet, Evidence of Coverage (EOC), or Subscriber Agreement prior to providing services; benefit variability may result in claim denial if services are billed under an incorrect benefit category.

Verify member's benefit booklet / Evidence of Coverage / Subscriber Agreement before billing
Coverage/billing may vary by group/contract and can trigger denial if incorrect benefit applied

Documentation Required

Demonstration and Training Documentation Required

When billing for home INR demonstration, training, or test-materials services, document a face-to-face demonstration, obtain and document at least one blood sample (or other required sample), provide instruction for reporting results, and document the patient's or caregiver's ability to perform testing and report results. Include documentation that supports use of the specific codes (G0248, 93792, G0249, G0250, 93793) as applicable.

G0248 and 93792 require documented face-to-face demonstration, sample obtained, instruction for reporting results, and documentation of patient/caregiver ability to perform and report testing
G0249 requires documentation of provision of test materials/equipment and frequency limits (testing not more than once weekly; billing units include 4 tests)
G0250 and 93793 require documentation of physician review/interpretation, patient management, instructions, any dosage adjustment, and scheduling of follow-up testing as appropriate

Billing Rule

Benefit Category Determines Billing

Coverage and billing for the listed codes depend on the benefit category under the member's contract (office visit, lab, or physician services). Bill codes under the appropriate benefit:

G0248 and 93792: covered under applicable office visit coverage
G0249: covered under applicable lab coverage
G0250 and 93793: covered under applicable physician services with no co-payment

Background

Warfarin is an effective anticoagulant used for treatment and prevention of venous and arterial thrombosis and is commonly prescribed long-term for conditions such as mechanical heart valves and chronic atrial fibrillation. Because therapeutic effect and safety depend on maintaining the International Normalized Ratio (INR) within a target range, periodic prothrombin time/INR monitoring is necessary: elevated INRs (for example, >3 and especially around INR of 6) are associated with substantially increased bleeding risk, while an INR <2 is associated with higher stroke risk. Home prothrombin time monitoring with FDA-cleared devices permits more frequent testing and self-management, which can increase time in therapeutic range and potentially reduce thromboembolic or hemorrhagic events.

Key Definitions

INR (International Normalized Ratio)

DefinitionINR (International Normalized Ratio): a standardized measure of prothrombin time used to monitor warfarin anticoagulation.

Clinical interpretation — high valuesAn INR greater than 3 indicates a higher risk of serious hemorrhage; an INR of 6 indicates an increased risk of a serious bleed nearly 7 times that of someone with an INR less than 3.

Clinical interpretation — low valuesAn INR less than 2 is associated with an increased risk of stroke.

Home INR devices — FDA‑cleared point‑of‑care systems

Examples of FDA‑cleared home INR systemsCoaguChek XS System (patient self-testing).

Additional cleared devicesProTime Microcoagulation System.

Additional cleared devicesAlere (formerly Hemosense) INRatio 2 PT/INR Monitoring System.