As technology and compliance requirements continue to evolve, medical practices must stay informed and proactive to ensure they are meeting current regulatory standards. Two key areas currently undergoing evaluation from the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) are Clinical Laboratory Improvement Amendments (CLIA) compliance and the proper use of remote patient monitoring (RPM). This article outlines what your practice needs to know—and do—to stay ahead of these changes and maintain compliance in both areas.
ISSUE 1: Several years ago, we introduced you to the CLIA requirements in this article. CLIA pertains to your practice if you see Medicare patients and perform some simple, low-risk tests—such as tear osmolarity and MMP-9/gelatinase B (InflammaDry; Quidel) for dry eye or other testing (eg, COVID-19, glucose). When CLIA applies to your practice, it requires the practice to obtain the Certificate of Waiver (COW). This is for facilities that perform only FDA-waived tests. CLIA has some new requirements coming our way.
UPDATE: In May, CMS announced a CLIA communications update: CLIA is moving to electronic fee coupons and CLIA certificates. To take full advantage of these improvements, laboratories and providers that perform laboratory testing have until March 1, 2026, to switch to CMS email notifications and begin receiving electronic CLIA fee coupons and certificates. After this date, paper fee coupons and paper CLIA certificates will no longer be available. All CLIA-related correspondence will also become electronic rather than by postal mail.
There are 2 ways to switch to electronic communications:
- Provide written notification to your State Agency by email (addresses found here).
- Fill out the CMS-116 application form. To switch to electronic notifications, check the box, “Receive notifications including electronic certificates via email.”
Additional information may be found on the CMS CLIA website.
ISSUE 2: RPM is growing more common for monitoring items like blood pressure, oxygen levels, and glucose for conditions like heart disease, obesity, and diabetes. This helps to extend care to patients and potentially reduce adverse events with tighter management and control of chronic diseases. RPM use is increasing in eye care; the iCare tonometer was our specialty’s first RPM tool, receiving US Food and Drug Administration (FDA) approval in 2017 as a take-home tonometer. If your practice is performing RPM, there is some important new compliance information to review.
UPDATE: The OIG and CMS have raised concerns about fraud related to RPM. In May 2025, CMS released some oversight results on the use of RPM for Medicare Part B patients. In the recent report, the OIG found a poor compliance rate of 43% for correctly performing all 3 aspects of providing RPM to patients, which are:
- Education and setup: Education about how to use the device and transmit the health data helps ensure that patients use the device appropriately to collect accurate data.
- Device supply: The internet-connected device, including the collection and transmission of at least 16 readings every 30 days, ensures that you get the appropriate health information. Examples of these devices include connected blood pressure cuffs, weight scales, and pulse oximeters. Without the connected device or an adequate number of readings, you may be left with insufficient or no data to make informed treatment decisions.
- Treatment and management: Treatment management ensures that you review the health data and use it to manage the patient’s condition.
If your practice provides RPM to patients, review the OIG’s report to ensure your protocols meet the CMS requirements to bill for RPM services, and update your policies and procedures and train your staff as needed to ensure compliance. Another helpful resource is the Telehealth and Remote Patient Monitoring page on the telehealth.hhs.gov website.
As compliance regulations evolve, staying informed and acting early helps your practice avoid compliance risks and maintain uninterrupted patient care. The shift to electronic CLIA communications requires timely action before the March 2026 deadline, while increasing scrutiny around RPM highlights the need for thorough documentation and adherence to all billing requirements. By reviewing your current processes, updating protocols, and training staff accordingly, your practice can stay compliant while delivering high-quality care in a rapidly changing health care environment. OP