AAHomecare Comments on Need for Levalbuterol

Alexandria, Va.

Last month, the American Association for Homecare submitted comments to CMS regarding the agency’s current review of levalbuterol in the treatment of chronic obstructive pulmonary disease.

In a six-page letter directed to CMS Acting Administrator Leslie Norwalk, the association said:

“While it may be argued there is only modest evidence demonstrating the benefits of levalbuterol over racemic albuterol in COPD, it is important to note that the absence of voluminous published clinical studies does not by itself establish a lack of clinical efficacy or medical need. This kind of extrapolation on limited data is purely speculative and conflicts with current standards of clinical practice, which defer to the patient’s physician the selection and prescription of the most clinically appropriate drug therapies.”

After review, the association said, it concluded that “the use of beta agonists, including levalbuterol, for the treatment of lung disease is reasonable and necessary and should by covered by the Medicare program.”

AAHomecare made the following points:

• Approximately 15 million Americans have been diagnosed with COPD, and an estimated 15 million more have undiagnosed COPD. The disease is the leading cause of morbidity and mortality worldwide.
• COPD is responsible for a significant part of all physician office and emergency room visits and ranks third in acute hospital admissions among Medicare-aged persons. The average length of stay for a COPD admission is 5.1 days at the rate of $4,000 per day. Medicare payments to hospitals for routine COPD admissions alone exceed $1.5 billion, and the disease costs the U.S. economy more than $18 billion a year in direct medical costs and an estimated $11 billion in indirect costs.
• The scientific evidence, national and worldwide expert panel recommendations and the current standards of care all recognize the vital role inhaled bronchodilators play in the safe, effective, and economically sound management of persons with COPD.
• While inhalation drugs do not specifically cure COPD, they can effectively manage its core symptoms in the outpatient/home setting and substantially reduce the need for more expensive medical interventions requiring ER visits and acute hospital admissions.