Friday, June 6, 2014

Recent guidance from state and federal regulators may leave some oxygen suppliers scrambling to comply with rules governing pharmacies. Apparently through a Medicare audit, the Wisconsin Department of Safety and Professional Services learned that a number of Wisconsin medical oxygen suppliers, distributors and manufacturers are out of compliance with state law because they do not have pharmacy, manufacturers, or distributor licenses. The Medicare auditor stated that unlicensed oxygen entities must come into compliance with state law.

The Wisconsin Pharmacy Examining Board recently posted guidance clarifying that the dispensing of oxygen by medical supply companies constitutes the “practice of pharmacy”. As a result, these companies must be licensed as pharmacies and licensed pharmacists must dispense the oxygen at a location that is either a pharmacy or a “remote dispensing site”. “Remote dispensing site” is a defined regulatory term and includes such locations as hospitals, nursing homes, community-based residential facilities, and offices of practitioners.

Additionally, the Board stated that companies that fill or refill portable medical oxygen containers are “manufacturers” and must obtain manufacturers’ licenses.

Pharmacy and manufacturing licenses come with a set of regulatory requirements. For example, pharmacy regulations require the company to have certain floor designs and equipment.

Entities providing oxygen should determine if they need additional licenses. In the meantime, an organization representing medical equipment suppliers is seeking relief from the licensing requirements. In addition, the Secretary of the Department of Safety and Professional Services has asked the Department of Health and Human Services for “a one year extension to allow oxygen suppliers, distributors, and manufacturers to come into compliance with the law.”

To read the Board’s guidance, please see this link.