Health Care Compliance Association – Hot Tips from the US Attorney’s Office at the New England Regional Conference

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The Health Care Compliance Association’s New England Regional Conference was held recently, and it was a day packed with useful information (and not just because I was one of the speakers).

The Health Care Compliance Association’s New England Regional Conference was held recently, and it was a day packed with useful information (and not just because I was one of the speakers).  I livetweeted the sessions (except my own), and I’d like to highlight the final session of the day, which featured Assistant U.S. Attorney Robert Trusiak, from the Western District of New York, and Carmen Ortiz, U.S. Attorney for the District of Massachusetts (who was in court earlier in the day for the sentencing of former Massachusetts Speaker Sal DiMasi — third speaker in a row to go from the State House to the Big House — but I digress).

While they always offer disclaimers, presentations by prosecutors offer a valuable glimpse of the government’s perspective.

Trusiak emphasized that his only goal is to find the truth, and that he runs an active monitoring program, but that his office’s agenda is mostly set by qui tam relators.  If relators (and/or members of his task force, which includes representatives from commercial payors and state and federal agencies, and meet with him regularly) identify potential issues with respect to a particular provider, his office will run down other issues relating to that provider.  Once one agency, such as the Department of Justice, is done with an investigation, prosecution or settlement negotiation, another agency (e.g., the OIG) may have the opportunity to pursue its own remedies.  Thus, a provider may be subject to criminal and civil sanctions arising from the same set of facts.

Ortiz emphasized that her office seeks to win the cooperation of targets of investigations; greater cooperation and disclosure to the U.S. Attorney’s office will result in mitigation of fines and sentences. That cooperation may include waivers of statutes of limitations — targets of investigations may waive the statute in order to have more time to produce information and present their cases informally, to convince the U.S. Attorney of the legitimacy of their practices, since the investigations are so time-intensive that time might otherwise run out (and the DOJ will simply bring the case they have prepared, without considering the other side of the story) without such an extension.

Both suggested that seeking criminal convictions for individual executives in cases of fraud by a corporate provider or supplier is a tactic reserved for the rare case where, per Ortiz, there is willful blindness to criminal activity or, per Trusiak, past sanctions imposed have not proven to be a sufficient deterrent.

Other tips included:

  • Review your compliance plan twice a year, just like your smoke detector batteries — to account for statutory changes, enforcement priorities and changes on the ground in your organization — and don’t forget to train employees
  • Under changes to the False Claims Act in the ACA, if, for example, a RAC audit finds overpayments going back 36 months, the provider has an obligation to dig deeper (37 months back, and further, as appropriate) and come clean, or face liability for failing to investigate when it had reason to know of potential false claims
  • Don’t forget to include nonemployed, privileged, docs in a hospital compliance program, becasue their noncompliance can expose a hospital to False Claims Act liability
  • Conduct internal surprise investigations, and run down any issues identified 
  • Come up with creative incentives for internal whistleblowing (i.e., to the compliance officer, not to the government) — you need to create an environment conducive to sharing this sort of information internally; many qui tam relators say they tried to tell higher-ups in their organizations, but nobody would listen

It is critically important to have a proactive approach to compliance, since failure to prevent issues, or failure to nip them in the bud, can only cause more pain. 

David Harlow
The Harlow Group LLC
Health Care Law and Consulting


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About author
DAVID HARLOW is Principal of The Harlow Group LLC, a health care law and consulting firm based in the Hub of the Universe, Boston, MA. His thirty years’ experience in the public and private sectors affords him a unique perspective on legal, policy and business issues facing the health care community. David is adept at assisting clients in developing new paradigms for their business organizations, relationships and processes so as to maximize the realization of organizational goals in a highly regulated environment, in realms ranging from health data privacy and security to digital health strategy to physician-hospital relationships to the avoidance of fraud and abuse. He's been called "an expert on HIPAA and other health-related law issues [who] knows more than virtually anyone on those topics.” ( His award-winning blog, HealthBlawg, is highly regarded in both the legal and health policy blogging worlds. David is a charter member of the external Advisory Board of the Mayo Clinic Social Media Network and has served as the Public Policy Chair of the Society for Participatory Medicine, on the Health Law Section Council of the Massachusetts Bar Association and on the Advisory Board of FierceHealthIT. He speaks regularly before health care and legal industry groups on business, policy and legal matters. You should follow him on Twitter.
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