Medicare does not cover any outpatient intravenous insulin treatments no matter what they are called.
In 2009, the Center for Medicare and Medicaid Services (CMS) ordered a National Coverage Analysis of outpatient intravenous insulin therapy (OIVIT). Before 2009, Medicare had already made a number of Local Coverage Decisions against MAT®treatment using various earlier names for the procedure. A number of patients appealed the denial of payment. (Appeals are a lengthy process, since each case and each treatment is a separate appeal.) Eventually at hearings before Administrative Law Judges, some of the treatments for some of the patients were approved for Medicare payment. This period of reimbursement was short–lived and by 2009, all patients’ payment appeals for payment by Medicare were consistently denied by Administrative Law Judges.
The National Coverage Analysis consisted of two periods of Public Comment , an assessment by CMS, and a National Coverage Decision Memo. The final National Coverage Determination stated that Medicare and Medicaid will not pay for outpatient intravenous insulin therapy. This decision removes the possibility of any appeal before Administrative Law Judges.
At the same time, CMS recognized outpatient intravenous insulin as a distinct type of therapy by assigning it a Billing Code that must be used when billing Medicare. CMS also ruled against billing for the individual parts that make up the treatment and will not cover the tests used to monitor the procedure. Medicare contracts with various health insurance organizations around the country to process Medicare bills and payments. A Medicare contractor may unknowingly pay a provider for a treatment not realizing there is a Medicare/Medicaid National Coverage decision against payment.
Later, when they discover the National Coverage Determination, the Medicare contractor can audit the clinic and demands the return of all payments. Suddenly, the clinic owner owes thousands of dollars to Medicare and may be investigated for fraud.
Gaining Medicare Approval
Despite Medicare’s current ruling against payment, we believe MAT® treatment will eventually gain Medicare approval. Outpatient intravenous insulin therapy holds great promise as a therapy for diabetes and other metabolic problems. How can the treatment gain Medicare approval? Large clinical trials over several years will be needed to convince Medicare of the benefits of this therapy in Medicare patients. For example, there have not been clinical studies to determine the benefits of this therapy in patients with type 2 diabetes. Many different types of diabetic complications are yet to be studied. ADRI is currently seeking funding for such clinical trials.
This area of science, outpatient intravenous insulin therapy, has received only limited study because intravenous insulin can cause the patient’s blood sugar to drop very rapidly, leading to coma or even death, Considering the safety concerns, Medicare may wish to limit any future approval to only those treatments offered by endocrinologists with training in the iv insulin procedure and the specialty knowledge to manage and maximize the effects of the therapy.