DME Compliance and Fraud Issues Pertaining to Continuous Glucose Monitors
Continuous glucose monitoring (CGM) systems have revolutionized the way doctors treat diabetes. By implanting a CGM device, a patient is able to track their blood glucose levels in real-time, allowing patients to know when their blood sugars levels are getting too high or too low. Realizing the benefits of CGM devices, in 2018, the federal government expanded Medicare coverage to pay for patients’ CGM devices. To be sure, this is a huge benefit for patients; however, in practice, billing issues have become a bit of a nightmare for providers.
The current Medicare guidance for CGM devices states, Medicare covers therapeutic continuous glucose monitors (CGMs) and related supplies instead of blood sugar monitors for making diabetes treatment decisions, like changes in diet and insulin dosage. If you use insulin and require frequent adjustments to your insulin regimen/dosage, a CGM may be covered if your doctor determines that you meet all of the requirements for Medicare coverage.
Thus, while Medicare may cover CGM devices, that is not always the case. And because CGM devices are much more expensive than traditional finger-sticks or other glucose-monitoring devices, doctors and pharmacies face tremendous hurdles when prescribing CGM devices and provide them to patients under federal law.
A provider’s failure to meet these requirements when prescribing a CGM monitor can lead to a federal audit. Similarly, a pharmacy’s incorrect billing of CGM devices can lead to similar concerns. Thus, it is important to keep the following in mind when dealing in CGM devices.
Not All CGM Are Covered Under Medicare
While some CGM are covered under Medicare, that isn’t the case for all models. Due to the fact that medical device manufacturers frequently tweak their products, there is no guarantee that a specific CGM is currently covered unless the pharmacy conducts an independent determination. Thus, pharmacies should not take a manufacturer’s word for it that a device is covered.
Billing and Coding Concerns
For the most part, a doctor makes the decision of whether a CGM is medically necessary. However, a pharmacy cannot ignore information indicating that isn’t the case. Further, just because a patient qualifies for a CGM device does not mean that a pharmacy is off the hook; the pharmacy must properly bill Medicare for the device. This requires a pharmacy bill Medicare under the proper code, bill only for devices actually provided to the patient, and avoid double-billing Medicare and a patient’s private insurance company.
CGMs as Durable Medical Equipment
Durable medical equipment (DME) can improve a patient’s quality of life significantly. And, in some cases, it can prolong a patient’s life. Thus, Medicare provides coverage for certain durable medical equipment (DME). However, Medicare only covers DME if:
- The specific DME is determined to be medically necessary;
- Use of the DME is cost-effective; and
- The DME will be used at a person’s home.
Additionally, DME must generally last for at least three years. Thus, historically, only therapeutic CGM qualified as DME. However, in a recent proposed change to the rule, the Centers for Medicare and Medicaid Services proposed that all CGM would be covered under Medicare. However, this policy is still under review and is not yet effective. Thus, as it currently stands, adjunctive (non-therapeutic) CGM devices do not qualify as DME and should not be billed as such.
Avoiding Impermissible Kickbacks
Pharmacies and doctors both need to be aware of the Anti-Kickback Statute and the regulations it imposes on their ability to receive compensation for a patient referral. Of course, not all referral relationships are prohibited. However, medical professionals must ensure that whatever agreement they come to complies with the law to avoid federal scrutiny.
Determining the extent of a healthcare provider’s obligations when prescribing CGM is not always a simple task, and it is easy for even a well-meaning physician to run afoul of federal regulations when doing so. Similarly, pharmacists walk a fine line as well, when attempting to fill orders for patients for CDM devices.
Contact a Federal Healthcare Lawyer for Help Answering Your Questions
If you have questions about the propriety of a billing structure, or you recently learned that you are under investigation by federal authorities related to continuous glucose monitors, reach out the Oberheiden, P.C. At Oberheiden, P.C., we have centuries of combined experience representing doctors and other healthcare professionals in all types of federal regulatory matters. Several of our senior attorneys previously handled investigations at the U.S. Attorney’s Office and can provide clients with valuable insights that are otherwise hard to come by. To learn more, reach out to one of our qui tam defense attorneys today at 1-888-680-1745. You can also reach us through our online form, and an attorney will promptly get in touch with you.