Q: Our laboratory is considering offering physicians the opportunity to request tests and receive test results electronically. What are some of the important regulatory issues we should consider?

A: Any such arrangement must comply with the federal self referral statute (Stark Law), the Federal Anti-Kickback Statute (FAS), and any state law that governs financial arrangements between providers of laboratory services and referring physicians. Additionally, the arrangement may not prevent a laboratory from complying with regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88), and from satisfying other legal and regulatory requirements.

There are several different types of arrangements for electronic transmission of information related to laboratory services. Since 1995, the Stark Law has permitted a clinical laboratory to provide items, devices, or supplies that are used solely to order or communicate the results of tests or procedures for the particular laboratory. This statutory provision permits a hospital or independent laboratory to provide a custom software interface to physicians that may be used solely to order tests or communicate test results with the hospital or laboratory. These types of arrangements can be integrated with the laboratory’s own system.