Last week the DMAC Web sites and The Centers for Medicare and Medicaid Services (CMS) coverage database published a revised medical policy on nebulizers.
According to the revision, all compounded inhalation solutions will be denied as not medically necessary, effective for claims with service dates on or after July 1, 2007.
The revision defined compounded inhalation solutions as product produced by a pharmacy that is not an FDA-approved manufacturer and involves the mixing, combining or altering of ingredients for an individual patient. Compounded drugs are not considered interchangeable with FDA-approved products.
According to CMS, the draft policy proposed eliminating coverage for inhalation solutions that are only available as compounded solutions. The PSCs received comments from multiple groups and individuals concerning general problems with compounded inhalation solutions. As a result of these comments and the absence of published clinical literature defining the need for compound inhalation solutions for an individual patient, the final policy extends noncoverage of compounded solutions beyond the specific drugs listed in the draft policy. All compounded inhalation solutions will be denied as not medically necessary.
The policy revision also incorporates the new HCPCS codes and revised coding guidelines that were effective for claims with service dates on or after Jan. 1, 2007.
In addition, the draft LCD that was released for comment proposed that levalbuterol be paid comparable to albuterol and that DuoNeb be paid comparable to individual unit dose vials of albuterol and ipratropium. CMS has initiated a National Coverage Analysis on Nebulized Beta Adrenergic Agonist Therapy for Lung Disease. Therefore, the PSCs are deferring a decision on the levalbuterol and DuoNeb LCD proposals pending the results of the National Coverage Analysis.
