ARIDOL, the only dry powder bronchial challenge test approved for use in the United States, is used to assess bronchial hyperresponsiveness in patients six years of age and older who do not have clinically apparent asthma.
With the ARIDOL-specific J-code in effect, office-based physicians who would like to use the dry powder bronchial challenge test and providers who currently use ARIDOL have a product-specific code to submit to payers which often increases the efficiency of the reimbursement process," said Stephen Beckman, President, Pharmaxis, Inc.
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.
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 (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.
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.
The ARIDOL Bronchial Challenge Test takes only about 20 minutes to administer for a positive test and requires a 15% reduction in FEV.
The safety and efficacy of ARIDOL as a bronchial challenge test were verified in two global Phase III clinical trials, which assessed the effectiveness of the ARIDOL bronchial challenge test in non-asthmatic patients with symptoms suggestive of asthma and clinically diagnosed asthmatic patients six years of age and older.
When approved, Aridol will be the first dry powder bronchial challenge test
available in the U.
It is the first and only bronchial challenge test approved Europe-wide.
Bronchial challenge tests are designed to assess bronchial hyperresponsiveness, an important marker in the diagnosis and assessment of asthma.
There is currently no FDA approved dry powder bronchial challenge test
available in the U.