In response to Andis Robeznieks' "CMS issues advisory opinion on software sharing":
While your read that the CMS letter is of limited use is correct, I think that you overstate the scope of that limitation.
Throughout the regulatory structures of the federal government, there is a tradition of responding to specific petitions and limiting the application of the relief to the petitioner. In this case, the health system that sought clarification that its licensing of its healthcare information technology system to physicians was not a self-referral in violation of the Stark rules is the only entity that can absolutely claim regulatory protection. But to conclude that the letter has no broader import is incorrect.
In the area of securities regulation, the Securities and Exchange Commission has an extensive body of enforcement guidance in what are called "no-action" letters. In a no-action letter, the SEC indicates to a petitioner that the specific action that they are seeking to take, within the limited set of facts that the petitioner describes, will not trigger enforcement action by the SEC. Every no-action letter carries the disclaimer that the decision of the SEC is limited to the facts presented by the petitioner, making itlike the CMS lettera limited protection.
Despite that limitation, attorneys across the country provide detailed advice and often formal legal opinions to clients all on the basis of the no-action positions of the SEC. While the specific ruling is limited in each letter, the underlying logic guides legal interpretations and provides a tremendous level of clarity upon which business decisions are made.
In the case of the CMS letter, it is fair to conclude that the CMS has addressed a substantial gap left in the regulatory position it took recently on Stark. Specifically, it has said that licensing of in-house systems will be treated the same as the transfer of commercially available systems for purposes of Stark compliance. That's a major decision by the CMS and its significance should not be understated because of the formal limitation language of the letter.
Healthcare organizations that have internally developed clinical IT systems can begin to move forward and work with their community's other caregivers. Those who are most cautious can seek similar CMS guidance, but they can do so knowing that an important precedent exists in favor of such arrangements.
Scott WallacePrincipalHealth Value AdvisorsChicago To submit a letter to YOUR VIEWS, click here. Please include your name, title and hometown.