7 Coding Facts You Can't Afford to Miss When billing for Enterra Therapy, as happens with many infrequent or unusual procedures, you may need some specialized knowledge to achieve successful reimbursement. Enterra Therapy is a treatment indicated for chronic nausea and vomiting associated with gastroparesis when conventional therapies are ineffective. In patients with gastroparesis, food moves through the stomach much more slowly than normal, with consequential severe, chronic nausea and vomiting that is not controllable by usual means. Patients have difficulty eating and may require tube feeding. Enterra Therapy uses a programmable neurostimulator system planted under the skin, plus stimulation leads attached to the stomach. The system is programmed after surgery to deliver small electrical pulses to the stomach. The continuous stimulation contracts the stomach muscle and helps control symptoms. When coding for private payers, she says, you should also use 64590 and 95972. Code the general procedure as 64999 (Unlisted procedure, nervous system); this automatically sends the billing into medical review, so you should include the operative report. Medicare Reimbursement For Medicare beneficiaries, Flansburg says that Medicare coverage for Enterra Therapy doesn't fall under the usual medical necessity guidelines of being "reasonable and necessary"; the U.S. Food and Drug Administration (FDA) has designated the system as a Humanitarian Use Device/Humanitarian Device Exemption (HUD/HDE). This means that the system is intended to treat or diagnose a disease or condition that affects, or is manifest in, fewer than 4,000 individuals per year in the United States. The HDE is a "determination that a HUD is safe, has probable benefit, and is not considered investigational/experimental." Specifically, the FDAnotice stated that Enterra Therapy is "For treatment of chronic intractable nausea and vomiting, secondary to gastroparesis of diabetic or idiopathic etiology." Making Successful Appeals Because of using 64999, you need to be prepared for an appeal. The Medtronic Web site, www.medtronic.com, provides a comprehensive description of the procedure, an explanation of HUD/HDE, suggestions on making a successful appeal, and more. It notes that if coverage was denied because the payer considered the process investigational or experimental, you can explain that the device is not investigational or experimental and has been granted FDA approval.
You can code this procedure with 64590 (Incision and subcutaneous placement of peripheral neurostimulator pulse generator or receiver, direct or inductive coupling) for placing the equipment, and for the equipment itself, 95972 (Electronic analysis of implanted neurostimulator pulse generator system ...; complex brain, spinal cord, or peripheral [except cranial nerve] neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, first hour). In all cases, it's important that you check your payer's policies for prior authorization and reimbursement, says Vicki Flansburg of the Economic Solutions Group for Enterra Therapy at Medtronic Inc.
This procedure is not always familiar to insurance payers, both because of the rarity of the condition and the relative newness of this treatment. For successful reimbursement, Flansburg adds, correct diagnostic coding is important. If the condition results from diabetes, for example, use 250.6x (Diabetes with neurological manifestations), then 536.3 (Gastroparesis).
What does this mean to coders? When handling Medicare claims, be sure to submit the proper diagnosis code and attach the FDA letter that discusses gastric electric stimulation. You'll find the letter at www.fda.gov; search for H990014.
Although many health plans and insurance companies do cover the cost of Enterra Therapy, because of its HDE status, experts recommend that the physician obtain prior authorization before implanting the device. When the payer does not request prior authorization, you should definitely document medical necessity and explain the procedure itself; include a description how two electrodes are implanted on the patient's stomach and how the device is programmed during the procedure.
If the payer feels that the procedure is not reimbursable because it was not medically necessary or is not a standard of care, you should provide additional information entailing how the procedure is performed and what its medical benefits are. Payers may just need to learn more about the procedure or understand its medical necessity.