CLIA Waived Tests for Manufacturers
Clinical Laboratory Improvement Amendment of 1988 (CLIA). The CLIA-waived status allows a broad base of physicians to perform a test at the point-of-care setting.
This list omits certain waived tests that are typically not performed in physician office settings.
Indications for usage of CPT code 83880
Congestive Heart Failure (CHF) is a complex clinical syndrome characterized by dysfunction of the left, right, or both ventricles, which results in the impairment of the heart’s ability to circulate blood at the rate sufficient to maintain the metabolic needs of the peripheral tissues and various organs. B-type natriuretic peptide (BNP) is synthesized, stored, and released primarily by the ventricular myocardium in response to volume expansion and pressure overload, which are hemodynamic parameters in CHF. Used in conjunction with other clinical information, serum BNP concentrations parallel dyspnea in heart failure suggesting its usefulness as a neurohormonal index of progressive heart failure. Serum BNP, for the purposes of coverage, is considered a ‘point-of-service test (performed and immediately used in the disposition of patient care).
Serum BNP, when used in conjunction with other clinical information, will be considered reasonable and necessary for the following:
Establishing the diagnosis of CHF in acutely ill patients presenting with dyspnea.
Predicting the long term risk of cardiac events or death across the spectrum of acute coronary syndromes when measured in the first few days after an acute coronary event. Since this situation is an inpatient service, it is not addressed in this LCD.
Serum BNP will be considered noncovered in the following:
Monitoring the efficiency of treatment for CHF
Tailoring the therapy for heart failure
Since BNP is a point of service test, the primary outpatient site of service expected to perform a serum BNP is the emergency room or a physician’s office.