In the most recent BNA Health Law Reporter, Health Law Reporter. 18 HLR 387, there was an article opining that harder economic times increases FCA qui tam and, in general, healthcare compliance risks. I found the following notable summary of reasons that compliance programs do not work as well as intended (taken from the BNA article, which, in turn takes from a February 11, 2009 presentation to the AHLA by Patrick S. Coffey, Chris J. Mollet, University of Illinois at Chicago, and Linda A. Wawzenski, assistant U.S. attorney for the Northern District of Illinois):
• Compliance is not a business priority;
• Programs do not operate as written and do not focus on heading off claims;
• Employee training is dull and ineffective;
• There is a lack of ongoing and meaningful risk assessment;
• Hotlines are not sufficiently promoted;
• Employees do not trust the compliance commitment so do not report concerns, while managers do not understand why this is so;
• Significant enforcement settlements are ignored or quickly forgotten;
• Organizations are not prepared to handle internal investigations and routinely mishandle internal reports;
• Disgruntled employees are dismissed and whistleblowers are not protected; and
• Difficult economic times are allowed to undercut compliance efforts.
Filed under: AKS, CMP, Compliance Programs, Fraud and Abuse, Health Law, Physician Self Referral/Stark, Risk Management, Health Law
OpenLetter3-24-09.pdf (application/pdf Object).
Today, March 24, 2009, the HHS OIG published and Open Letter informing us that providers can no longer used the Self-Disclosure Protocol (SPD) for the physician self-referal (“Stark”) law and will limit SPD submissions to those with a minimum $50,000 settlement.
OIG will no longer accept disclosure of a matter that involves only liability under the physician self-referral law in the absence of a colorable anti-kickback statute violation. We will continue to accept providers into the SDP when the disclosed conduct involves colorable violations of the anti-kickback statute, whether or not it also involves colorable violations of the physician self-referral law… To better allocate provider and OIG resources in addressing kickback issues through the SDP, we are also establishing a minimum settlement amount. For kickback-related submissions accepted into the SDP following the date of this letter, we will require a minimum $50,000 settlement amount to resolve the matter.
The Open Letter casts this as necessary to ensure resources are focused on antikickback violations. These “remain a high priority for OIG.” OIG does caution that providers should not read this decision to “draw any inferences about the Government’s approach to enforcement of the physician self-referral law.”
This is a rather remarkable position given the challenges that health systems face with technical (and sometimes potentially costly) Stark violations without any antikickback component. And, notwithstanding the OIG’s caution, it is clear that the OIG, recognizing resource limitations, wants to focus on anti-kickback violations rather than purely Stark law violations. And what about civil monetary penalties SDPs associated with inducement of patients? One must conclude that if there is not a significant antikickback component, it is not now appropriate for the SDP due to limitations with OIG resources. Probably more to come.
Filed under: AKS, CMP, Fraud and Abuse, Health Law, Physician Self Referral/Stark