Radiologists and imaging centers are often asked to make the diagnostic studies they perform available to an ordering physician through the physician’s electronic health records (EHR) system. The difficulty in accommodating these requests stems in part from the sheer variety of EHR and RIS/PACS systems. In most circumstances, some type of software interface, and possibly hardware, is required to connect the two systems. Someone has to purchase this hardware and software, of course.
While it may make good business sense for an imaging center or radiology practice to provide and pay for software upgrades necessary for the RIS/PACS to interface with the EHR or to install hardware, such as viewing stations, in the ordering physician’s office, these types of arrangements can raise significant regulatory issues. Federal and state laws prohibit radiologists and imaging centers from offering referring physicians something of value in return for ordering diagnostic tests. Because software upgrades and computer hardware provide real value to ordering physicians, these types of arrangements should be carefully considered under the relevant federal and state law.
Many connectivity arrangements are capable of meeting an exception to the federal physician self-referral law, or “Stark law,” allowing the radiologist or imaging center to fund and install the software interface. Under state and federal anti-kickback statutes, however, funding these systems on behalf of referring physicians raises more complex compliance issues. There are no safe harbors in the federal anti-kickback statute that explicitly protect such arrangements from scrutiny. Accordingly, the question becomes how to structure a connectivity arrangement in a way that adequately protects the parties from scrutiny under state and federal anti-kickback statutes.
Software Interfaces and Remuneration Under Stark
As a general rule, the Stark law, in the absence of an exception, prohibits physicians from referring Medicare and Medicaid patients to an imaging center for a diagnostic test if the physician has a direct or indirect financial relationship with the imaging center or interpreting radiologist. 1 For these reasons, determining whether IT services or assets constitute “financial relationship” under the Stark law is paramount.
According to the regulations, a “financial relationship” includes any arrangement involving any remuneration between a physician (or an immediate family member of such physician) and an entity providing designated health services. “Remuneration” is defined to include anything of value, in kind or in cash, but, importantly, the definition specifically excludes the “furnishing of items, devices, or supplies . . . used solely to order or communicate the results of tests or procedures for the entity.” 2
In many circumstances, a software interface is installed for the sole purpose of communicating the results of diagnostic tests by connecting the EHR to the RIS/PACS. Accordingly, many of the items required to establish connectivity are excluded from the definition of “remuneration,” and, therefore, do not create a financial relationship between the referring physician and the radiologists or imaging center. If a financial relationship does not arise, radiologists and imaging centers may assist the ordering physician without implicating the Stark law.
CMS recognized this exception from the definition of “remuneration” in its Advisory Opinion CMS-AO-2008-01. Following the logic of this advisory opinion, radiologists and imaging centers may assist with the purchase and installation of a software interface without implicating the Stark law because the items and services provided do not create a “financial relationship.”
Ins and Outs of the EHR Exemption
The EHR exception states that certain arrangements involving the donation of EHR technology and training services to a physician by an entity to which the physician may refer Medicare and/or Medicaid patients do not create a financial relationship between the referring physician and that entity and, thus, would not violate the Stark law.
This exception applies to interface and translation software, connectivity services, maintenance services, and training and support services (for example, access to a help desk). CMS has specifically stated that a donation of software and services may not include hardware, storage devices, software with core functionality other than