As many healthcare providers migrate to electronic health records (EHRs), clinical laboratories and diagnostic imaging centers have sought to provide their referring physicians with a limited-use EHR interface that allows the physician offices to submit orders and review test results electronically.
Over the past several years, the Centers for Medicare and Medicaid Services (CMS) and the U.S. Department of Health and Human Services Office of the Inspector General (OIG) have separately approved such arrangements through regulatory guidance and advisory opinions.
In general, limited-use EHR interfaces allow referring physician practices to electronically submit orders for diagnostic services directly to clinical laboratories and diagnostic imaging centers via the physician’s EHR. In addition, the clinical laboratories and diagnostic imaging centers can send reports electronically to the referring physician’s EHR. This EHR interface eliminates the need to fax orders and reports back and forth and also allows immediate entry into the EHR of such records. The limited-use EHRs generally have the following characteristics:
- They have no independent value to the physician.
- Their use is limited to sending and receiving information between a referring physician and a clinical laboratory or diagnostic imaging center.
- It is integrally related to the provision of the clinical laboratory’s or diagnostic imaging center’s services.
Clinical laboratories and diagnostic imaging centers have sought to pay for the cost of installing the interface with a referring physician’s office. The arrangement typically works as follows:
- The clinical laboratory or diagnostic imaging center purchases an interface license and pays the annual software maintenance fee. They also pay a one-time installation and set-up fee. The interface vendor invoices the clinical laboratory or diagnostic imaging center directly for these charges.
- The clinical laboratory or diagnostic imaging center pays for the costs associated with developing software to connect their IT system to the interface software purchased in step 1.
- The clinical laboratory or diagnostic imaging center pays for any costs associated with establishing network connectivity with the referring physician practices.
Based on a review of guidance from the OIG and CMS, it is clear that providing a limited-use interface to referring physicians is allowed, and does not violate the Anti-Kickback Statute (AKS) or Stark Law. Nonetheless, clinical laboratories and diagnostic imaging centers should develop a compliant process in which to select those physicians who will receive the interface.
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