As physicians become more involved in the provision of ancillary services, many also want to be able to provide DME to their patients. Under the Stark Law, DME is a designated health service. A physician who both orders DME and provides that DME is making a self-referral, which triggers Stark and necessitates meeting a Stark exception.

The only exception available is for In-Office Ancillary Services (“In-Office Exception”). Under Stark III regulations, the following types of DME can be provided pursuant to the In-Office Exception: canes; crutches; walkers; blood glucose monitors; and folding manual wheelchairs. All other DME, including C-PAP equipment, cannot be referred under the In-Office Exception.

For a physician to both order and provide DME that does not qualify for the In-Office Exception, the physician must: (1) enroll with Medicare as a DME provider; and (2) personally provide the DME. In order to personally provide the DME a physician must minimally:

• Personally fit the DME item for the patient;
• Provide necessary information and instructions concerning use of the DME;
• Advise the patient that he or she may either rent or purchase inexpensive or routinely purchased DME;
• Explain the purchase options for capped rental DME;
• Explain all warranties;
• As needed, deliver the DME to the patient at his or her residence; and
• Explain to the patient at the time of deliver how to contact the physician in his or her capacity as a DME supplier.

CMS notes, however, that it is highly unlikely that a referring physician would meet these criteria for personally performed services when dispensing DME.

Physicians can avoid having to personally perform the provision of DME and enroll as a DME supplier if they refrain from supplying DME to their Medicare and Medicaid patients. Providing DME strictly to non-federal healthcare patients falls outside the scope of the Stark law and does not present a problem under similar Illinois self-referral provisions.