**History/Background and/or General Information**

Congestive Heart Failure (CHF) is characterized by a progressive activation of
the neurohormonal systems that control vasoconstriction and sodium retention;
the activation of these systems plays a role in its pathogenesis and
progression. As the heart fails, B-Type Natriuretic Peptide (BNP), a cardiac
neurohormone is secreted from the cardiac ventricles in response to
ventricular volume expansion and pressure overload. Used in conjunction with
other clinical information, rapid measurement of BNP is useful in establishing
or excluding the diagnosis and assessment of severity of CHF in patients with
acute dyspnea so that appropriate and timely treatment can be initiated. This
test is also used to predict 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. For the purposes of this LCD, the total
and N terminal assays are both acceptable.

**Covered Indications**

B-Type Natriuretic Peptide (BNP) measurements will be considered medically
reasonable and necessary to establish or exclude the diagnosis and assessment
of severity of CHF in patients with acute dyspnea when used in combination
with other medical data such as medical history, physical examination,
laboratory studies, chest x-ray, and electrocardiography (ECG). Rapid
measurement of BNP concentration in the blood appears to be a sensitive and
specific test for differentiating patients with CHF from primary pulmonary
causes of dyspnea in acute care settings.

  * Plasma BNP levels are significantly increased in CHF patients with or without concurrent lung disease compared with patients with primary lung disease.
  * Plasma BNP levels are significantly increased in CHF patients presenting with acute dyspnea compared with patients presenting with acute dyspnea due to other causes.
  * BNP levels are also useful for risk stratification (to assess risk of death, myocardial infarction or congestive heart failure) among patients with acute coronary syndrome (myocardial infarction with or without T-wave elevation and unstable angina).

**Limitations**

BNP measurements must be analyzed in conjunction with standard diagnostic
tests, the medical history, and clinical findings; its efficacy as a stand-
alone test has not yet been established.

Additional investigation is required to further define the diagnostic value of
plasma BNP in monitoring the efficiency of treatment for CHF and in tailoring
the therapy for heart failure. Therefore, BNP measurements for monitoring and
management of CHF are not a covered service.

Generally, it is not expected that this test would be performed more than four
times in a year.

BNP measurements are not a covered service when performed as a routine
screening procedure, in the absence of documentation of clinical findings in
the patient's medical record indicating suspected CHF, or for monitoring and
management of CHF.

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.