Opioids, off-label marketing, and the home health industry will remain priorities for federal and state attorneys enforcing health care laws, according to comments made at the Boston Bar Association's (BBA) White Collar Crime Conference.
The conference, held in Boston on April 22, featured speakers from the civil and criminal divisions of Boston's U.S. Attorney's Office and from the Massachusetts Attorney General's Office.
Civil enforcement by the U.S. Attorney's Office continues to focus on health care fraud, according to Gregg Shapiro, Chief of the Affirmative Civil Enforcement Unit. While high drug prices are a policy concern in Washington, D.C., Shapiro said this policy issue was not behind enforcement decisions – regulators remain focused on the use of kickbacks to boost sales.
Amanda Strachan, Acting Chief of the Health Care Fraud Unit in the Criminal Division of the U.S. Attorney's Office, discussed how her unit thinks about off-label marketing. She stated that patient harm drives enforcement decisions, echoing recent statements by Ethan P. Davis, Deputy Assistant Attorney General for DOJ's Consumer Protection Branch. In addition, she looks at companies to see if there is a mismatch between the business model and the company's structure. She gave Insys as an example, where the company had a sales force that was larger than seemed necessary to sell what she called a hospice drug.
For the Massachusetts AG, nursing homes and the home health industry are key enforcement areas, said Toby Unger, the Chief of the Medicaid Fraud Division. She stated that there was a systemic failure in nursing homes, and the growing home health industry was not just a response to troubled nursing homes but the result of frauds and scams in the industry. She plans to use civil and criminal enforcement to "right size" the Massachusetts home health industry, whose rapid growth led to a moratorium on home health agencies in 2016.
All identified the opioid crisis as a focus for their offices. On the federal side, that emphasis is driven in part by direction from Washington, D.C., but as Unger emphasized, Massachusetts is no stranger to the opioid crisis and has its own motivation for tackling the issue.
A final trend in health care enforcement is simply that there is more of it, and more lawyers working on it. Strachan reported that there are three new Assistant U.S. Attorneys in her office, while Shapiro reported two new additions, giving his unit the most attorneys it has ever had. Unsurprisingly, this has led to great activity. There have already been more indictments and charges from the Health Care Fraud Unit in 2019 than there were in 2018, and private enforcement by qui tam relators in Massachusetts is rising in both state and federal courts.
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