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New Waived Tests - Centers for Medicare & Medicaid Services

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TESTS GRANTED WAIVED STATUS UNDER CLIA<br />

CPT CODE(S) TEST NAME MANUFACTURER USE<br />

4. HemoCue Hemoglobin 201+<br />

(Capillary, Venous, Arterial<br />

Whole Blood)<br />

5. HemoCue Hemoglobin<br />

201+/HemoCue Hemoglobin<br />

Microcuvette System<br />

HemoCue, Inc.<br />

HemoCue, Inc.<br />

6. HemoCue Hb 301 System HemoCue, Inc.<br />

85018QW(cont.) 7. GDS Diagnostics HemoSite<br />

Meter - <strong>for</strong> hemoglobin<br />

85576QW<br />

8. GDS Technology STAT-Site<br />

MHgb Test System<br />

Accumetrics VerifyNow Aspirin<br />

Assay<br />

GDS Technology, Inc.<br />

GDS Technology<br />

Accumetrics Inc.<br />

Measures hemoglobin level in whole blood<br />

Qualitative assay to measure platelet aggregation<br />

85610QW<br />

(Contact your<br />

<strong>Medicare</strong> carrier<br />

<strong>for</strong> claims<br />

instructions.)<br />

1. AvoSure PT System<br />

(prescription home use)<br />

2. AvoSure Pro (professional<br />

use)<br />

3. CoaguChek PST <strong>for</strong><br />

Prothrombin Time<br />

4. CoaguSense Self-Test<br />

Prothrombin Time/INR<br />

Monitoring System<br />

(Prescription Home Use)<br />

Avocet Medical, Inc. Aid in screening <strong>for</strong> congenital deficiencies of Factors II, V,<br />

VII, X; screen <strong>for</strong> deficiency of prothrombin; evaluate heparin<br />

effect, coumadin or warfarin effect; screen <strong>for</strong> Vitamin K<br />

deficiency<br />

Avocet Medical, Inc.<br />

Boehringer Mannheim<br />

Corporation<br />

Coagusense, Inc.<br />

5. HemoSense INRatio System HemoSense, Inc.<br />

* <strong>New</strong>ly added waived test system 37

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