Aerocrine to Provide Insurance Coverage of FeNO Test in U.S.

Aerocrine AB has announced that Health Care Service Corp. will begin covering FeNO testing for asthma diagnosis and management effective April 1.

In a release, the Company said that it has received notification that Health Care Service Corp. (HCSC) will implement a positive coverage policy for Fractional exhaled Nitric Oxide (FeNO) testing for the diagnosis and management of asthma effective April 1. HCSC, a private payer in the US, provides insurance coverage for 14 million individuals. HCSC subsidiaries include Blue Cross and Blue Shield plans of Illinois, Montana, New Mexico, Oklahoma, and Texas.

Aerocrine said that the new HCSC policy is a positive coverage policy that states FeNO testing may be considered medically necessary for the diagnosis and treatment of asthma. This change in policy now allows reimbursement of claims based on medical necessity. In the last three years, several of the large Blue Cross and Blue Shield plans have altered their policies to begin paying for Aerocrine's test. These include: WellPoint/Anthem Blue Cross Blue Shield, Blue Cross Blue Shield of Florida, Horizon Blue Cross and Blue Shield, Blue Cross and Blue Shield of Minnesota and Premera Blue Cross Blue Shield. Aerocrine's test is now reimbursed by the three largest Blue Cross and Blue Shield companies in the United States, plans that account for over 40 million covered lives. In all, 64 percent of US insured lives now have access to Aerocrine's test nationwide.

HCSC, spent many months reviewing the latest information available and thoroughly challenged the clinical utility and outcomes information. This is a very positive change that we hope will encourage other payers to review their FeNO coverage policies and provide coverage," said Scott Myers, CEO, Aerocrine AB "We believe this change at HCSC will demonstrate to physicians that insurers support FeNO testing to improve clinical decision making, patient and health economic outcomes for asthma management."

Insurance companies typically review their medical policies on an annual basis or whenever substantially new clinical information becomes available. Currently, seven of the US's top 12 insurers provide coverage and reimbursement for this test. During the first quarter; Cigna and Highmark, the fourth and eighth largest insurers respectively have maintained a non-coverage policy.

FeNO testing is a two minute, objective, point-of-care breath test that can be used to identify patients with allergic airway inflammation. Airway inflammation is recognized as the underlying cause of asthma. Using routine FeNO testing to guide therapy, particularly inhaled corticosteroid therapy, for asthma patients has been shown to reduce asthma exacerbations up to 50 percent.

"FeNO is an important addition to the management of many patients with asthma. It allows the presence of steroid responsive airway inflammation to be identified. FeNO testing helps clinicians prescribe the optimal medications and doses for their asthma patients which can improve patient outcomes," said Dr. Neal Jain, MD, FAAAAI, FAAP.

Aerocrine said that its NIOX MINO is the only FeNO device that is cleared by the FDA and commercially available in the United States. NIOX MINO is a simple device that delivers a numerical FeNO score during routine patient visit.

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