While the Centers for Medicare and Medicaid Services (CMS) updated guidance pertaining to continuous glucose monitoring devices (CGM) in 2018, the regulatory landscape is still far from clear. The result is that healthcare providers, including doctors, pharmacists and manufacturers of these devices all face a labyrinth of red tape. However, federal healthcare fraud investigators are unsympathetic to the complex nature of these regulations and continue to take an aggressive approach to any perceived errors.
Under the most recent CMS regulations, CGM devices may be covered under Medicare, but that is not always the case. The most recent guidance provided by the CMS provides,
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.
In order for Medicare to cover CGM devices, each of the following must be met:
- The Medicare beneficiary is diagnosed with diabetes mellitus;
- The Medicare beneficiary is treated with insulin three or more times per day or through a continuous subcutaneous insulin infusion pump; and
- The Medicare beneficiary’s treatment regimen requires frequent adjustment on the basis of BGM or CGM testing results.
Additionally, the treating physician must conduct an in-person visit with the beneficiary to evaluate their progress and determine that the above criteria are met within six months of ordering the CGM. From there, the treating physician must conduct additional visits every six months to ensure that the patient is adhering to their treatment plan.
However, from a provider’s perspective, it can be challenging for providers to understand when they can order and bill for CGM devices for patients on Medicare. For example, there are two types of CGM devices: therapeutic and non-therapeutic. Currently, only therapeutic CGM devices are compensable under Medicare. While there have been efforts to extend Medicare coverage to non-therapeutic devices, these changes have not yet gone into effect. Thus, providers should avoid billing Medicare for non-therapeutic devices.
Additionally, the manufacturers of CGM devices regularly make small adjustments to their product, which then requires the product to undergo the Medicare-approval process. Thus, it can be difficult for providers to know which specific models are covered under Medicare, given that they are frequently in flux.
Despite the challenges providers face, the federal government is focused on the fact almost a third of all CGM-related billings are improper. In 2019, incorrect billing for CGMs resulted in about $74 million in improper payments. As a result, federal investigators keep a close watch on providers who order CGM devices for Medicare patients.
What Can Providers Do to Avoid Federal Scrutiny?
For any provider who regularly orders CGM devices as DME for Medicare patients, it is imperative that they develop a comprehensive compliance program. A compliance program serves two purposes. First, it helps to mitigate the risk of inadvertent errors. When a provider sits down to create a compliance policy, it requires they familiarize themselves with all current regulations. Necessarily, as the compliance policies are distributed to staff, it educates others about how to stay in compliance and the importance of doing so. Additionally, having a compliance program on the books can also influence investigators charging decisions in the event of a violation. In other words, federal authorities are more likely to chalk an error up to an honest mistake if the provider has taken the time to develop and follow a compliance program.
As one of the primary investigative agencies looking into allegations of healthcare fraud, the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) provides compliance guidance to healthcare providers. According to the most recent guidance, any compliance program should contain the following elements:
- Developing of written policies, procedures and standards of conduct;
- Naming of a compliance officer or a compliance committee (for larger practices);
- Conducting effective staff education on the importance of compliance;
- Allowing for open lines of communication between staff, compliance officers, and management;
- Regular internal monitoring of the practice and its specific compliance risks;
- Creating and posting disciplinary guidelines to inform staff of the consequences of non-compliance; and
- Prompt enforcement of the compliance standards upon a finding of a potential violation.
It is also important to understand that compliance is not a one-time task but an ongoing effort. Providers must ensure that their billing procedures pertaining to CGM devices are updated when regulations change.
The Risk of Non-Compliance
As with most healthcare fraud issues, the government can pursue civil or criminal liability against a provider, depending on the nature of the violation. In most cases, absent evidence of intentional misconduct, the government will proceed with a civil claim. However, even a civil healthcare fraud lawsuit can result in significant fines and penalties, disgorgement and injunctions. Of course, criminal liability carries the possibility of federal imprisonment.
Are You Concerned About Your CGM Billing Practices?
If you are a healthcare provider and have concerns about the frequently changing regulations related to CGM devices, it is imperative that you reach out to a dedicated healthcare compliance attorney at Oberheiden, P.C., as soon as possible. A federal investigation into your practice comes at a high cost, even if authorities ultimately clear you of any wrongdoing. At Oberheiden, P.C., our federal healthcare compliance and defense lawyers have over a century of experience helping providers understand and meet their compliance obligations. To learn more about the services we provide, give Oberheiden, P.C. a call at 866-603-4540 today. You can also connect with us through our online contact form.
Dr. Nick Oberheiden is a national litigation and trial criminal defense attorney who practices exclusively in the area of federal law.