EXTON, Pa., Nov. 7, 2011 /PRNewswire/ -- Pharmaxis, Inc.
today announced that the Centers for Medicare and Medicaid Services
(CMS) has assigned a unique, Level II Health Care Common Procedural
Coding System (Level II HCPCS), commonly referred to as a J-code,
to ARIDOL® (mannitol inhalation powder) Bronchial Challenge Test
Kit, which is used to assess bronchial hyperresponsiveness in
patients six years of age and older who do not have clinically
apparent asthma. ARIDOL should not be used as a stand alone
test to assess asthma or as a screening test for asthma, but as
part of a physician's overall assessment of asthma. The new
J-code becomes effective on January 1,
2012.
(Photo: http://photos.prnewswire.com/prnh/20111107/NY00591
)
J-codes are used by providers to bill Medicare Part B, Medicaid
and most private plans for drugs administered in physicians'
offices and hospital outpatient settings.
"This is an important milestone for Pharmaxis, and we are very
pleased to have made substantial progress on the reimbursement
front since launching ARIDOL in February 2011," said Stephen Beckman, President, Pharmaxis, Inc.
"The J-code should facilitate reimbursement for providers who
currently use bronchial challenge tests as part of their asthma
assessment protocol, as well as for office-based physicians that
would like to offer ARIDOL due to its ease of administration."
About ARIDOL
ARIDOL® (mannitol inhalation powder) Bronchial Challenge Test
Kit is a single-use, indirect test that is easy-to-administer,
requires minimal preparation time and a 15% reduction in lung
function from baseline for a positive test. ARIDOL was
approved by the U.S. Food and Drug Administration (FDA) on
October 5, 2010, and demonstrated
safety and efficacy in two Phase III clinical trials.
ARIDOL can be ordered directly from Pharmaxis and is available
to pulmonary function labs and physicians' offices by calling
Pharmaxis Customer Service at 1-888-416-1828.
Indication
Mannitol, the active ingredient in ARIDOL, is a sugar alcohol
indicated for the assessment of bronchial hyperresponsiveness in
patients 6 years of age or older who do not have clinically
apparent asthma.
ARIDOL is not a stand alone test or a screening test for asthma.
Bronchial challenge testing with ARIDOL should be used only
as part of a physician's overall assessment of asthma.
Important Safety Information
WARNING: RISK OF SEVERE BRONCHOSPASM
Mannitol, the active ingredient in ARIDOL, acts as a
bronchoconstrictor and may cause severe bronchospasm.
Bronchial challenge testing with ARIDOL is for diagnostic
purposes only. Bronchial challenge testing with ARIDOL should
only be conducted by trained professionals under the supervision of
a physician familiar with all aspects of the bronchial challenge
test and the management of acute bronchospasm. Medications (such as
short acting inhaled beta-agonist) and equipment to treat severe
bronchospasm must be present in the testing area. If severe
bronchospasm occurs it should be treated immediately by
administration of a short acting inhaled beta-agonist. Because of
the potential for severe bronchoconstriction, bronchial challenge
testing with ARIDOL should not be performed in any patient with
clinically apparent asthma or very low baseline pulmonary function
tests (e.g., FEV1
