CMS recently issued an Advisory Opinion suggesting that physicians who refer diagnostic tests reimbursable under Medicare to a laboratory may, under certain circumstances, receive electronic pop-up notifications in the laboratory’s web-based portal alerting the physicians to various potential issues related to the test results.  In the Advisory Opinion, CMS considered certain alerts which a laboratory proposed to provide to its referring physicians without charge via the laboratory’s web-based portal.  The entire Advisory Opinion can be read here.

In short, CMS concluded that the alerts proposed by the laboratory, which would be limited to issues relating to the test results, would not constitute illegal remuneration under the federal Stark law, as long as (1) the alerts are provided solely in connection with the ordering or communication of diagnostic test results from the laboratory, and (2) appropriate safeguards are in place to avoid overutilization or medically unnecessary testing.

Some of the key safeguards that CMS found persuasive included the following:

  • Alerts recommending additional testing would be based on industry-standard, peer-reviewed guidelines;
  • The alerts would not be “overly intrusive” and would not override the physician’s independent medical judgment;
  • Where multiple additional tests would be recommended in an alert, there would be no “select all” button for the physician to click to order all of the tests together;
  • The physician could turn off the alerts for a particular disease condition; and
  • The physician could obtain the information provided in the alerts free of charge from other sources.

An advisory opinion from CMS is a rare occurrence, in comparison to advisory opinions issued by the Office of Inspector General regarding the federal Anti-Kickback Statute, which occur a number of times each year.  This is the first and only advisory opinion issued by CMS in 2017.  To that end, CMS likely considers this Opinion to be useful guidance to physicians and providers regarding their use of online web portals to order diagnostic tests.

If you or your practice has any questions regarding alerts or other benefits you may receive via a laboratory’s online web portal, please consult experienced legal counsel.