A Continuous Glucose Monitor (CGM) is a small, wearable medical device that automatically measures glucose levels in the interstitial fluid just beneath the skin. This technology provides a continuous stream of data, allowing users to see glucose trends throughout the day and night without frequent fingerstick checks. Understanding whether a prescription is required to obtain a CGM is important for anyone considering this technology.
The Current Prescription Status of CGMs
For a long time, the answer to whether a prescription was needed was a definitive “yes.” Traditional, therapeutic CGMs, such as the Dexcom G7 and Abbott’s Freestyle Libre devices, are classified as prescription-only medical equipment in the United States. This requirement applies to the initial transmitter and the subsequent sensors needed for continued use. The prescription is tied to the device’s intended use for managing conditions like type 1 or type 2 diabetes, where the data informs decisions about medication, especially insulin dosage.
This landscape recently changed with the introduction of over-the-counter (OTC) options. In March 2024, the U.S. Food and Drug Administration (FDA) cleared the first OTC continuous glucose monitor, the Dexcom Stelo Glucose Biosensor System. This non-prescription device is intended for individuals 18 years and older who do not use insulin. Other companies, like Abbott with its Lingo biosensor, have also entered the OTC market, offering devices for general wellness and health insights.
OTC devices are distinct because they are not intended for users with problematic hypoglycemia or for making insulin-dosing decisions. Therefore, while most CGMs used for intensive diabetes management still require a healthcare provider’s authorization, devices for general health tracking are now available without a prescription. The regulatory status depends on the specific device and its cleared indications for use.
Medical Necessity and Regulatory Classification
Most CGMs require a prescription because they are classified as medical devices, and incorrect use carries the potential for patient harm. The FDA classifies integrated Continuous Glucose Monitoring Systems (iCGMs) as Class II medical devices. This classification means that general controls are insufficient to guarantee safety and effectiveness, necessitating “special controls” that include rigorous performance testing and specific labeling requirements.
The complexity of the data produced by these systems also necessitates clinical oversight. A CGM provides information that requires interpretation to make safe and effective treatment adjustments. Misinterpreting a glucose trend or an alarm can lead to serious adverse events, such as dangerously low or high blood sugar levels.
For a therapeutic device, the prescription confirms that a qualified healthcare professional has determined the device is medically appropriate. This oversight ensures the user is adequately trained and understands how to safely incorporate the glucose data into their diabetes management plan. The regulatory barrier protects patient safety by linking the device to professional medical guidance.
Navigating the Prescription Process
Individuals who require a therapeutic CGM must first consult a healthcare provider, typically a primary care physician or an endocrinologist. The provider evaluates the patient’s medical history and treatment regimen to determine medical necessity. A common qualification for prescription CGMs is a diagnosis of diabetes and the use of insulin, or a documented history of severe hypoglycemia.
The clinician must document that the CGM is prescribed according to the device’s FDA indications for use and that the patient or caregiver has received sufficient training. For Medicare coverage, this often includes a required in-person or telehealth visit within six months prior to ordering the device to evaluate diabetes control. This documentation justifies the medical need for the device and supports any subsequent insurance claim.
Once the prescription is written, it can be filled in one of two ways. Many modern CGM prescriptions, including sensors and transmitters, are filled through a retail pharmacy. Alternatively, some prescriptions may be processed through a Durable Medical Equipment (DME) supplier, depending on the device and the patient’s insurance plan.
How Prescription Status Impacts Insurance Coverage
The distinction between a prescription-required CGM and an OTC option carries significant weight regarding cost and insurance coverage. Both private health plans and government programs like Medicare and Medicaid require a valid prescription and documented medical necessity before covering the cost of a CGM. Without this authorization, the patient is responsible for the full retail price, which can be substantial.
For prescription devices, insurance coverage is determined by where the prescription is filled. If the CGM is covered under the pharmacy benefit, the patient pays a copay similar to that of a medication, often resulting in a lower out-of-pocket cost. If the device is covered under the DME benefit, the cost is subject to the plan’s deductible and coinsurance for medical equipment.
For newer OTC CGMs, insurance coverage is generally not provided because they are not considered medically necessary for managing a diagnosed condition. While some benefit plans are exploring coverage for wellness devices, most patients purchasing an OTC CGM for general health or fitness monitoring must pay for it entirely out-of-pocket. Therefore, the prescription status of a CGM is the primary gatekeeper for financial reimbursement.