Life Science Compliance Enforcement After 100 Days of Biden: They'll Follow the Money!

Since the 1970’s and Watergate, the adage, “Follow the money!” has summed up what government investigators do to crack a case.  In 1992 the Clinton Administration declared war on health care fraud.  For nearly thirty years, this “endless war” has been growing together with its associated recoveries, settlements, prosecutions and convictions.  Why?  There’s more money than ever in the system.

In 2001, exactly twenty years ago, the war was expanded into the pharmaceutical/life sciences industry sector.  The trend continued under the Bush and Obama administrations, and while the Covid-19 pandemic put a slight pause on enforcement activity, a recent Special Fraud Alert for Speaker Programs from the Office of the Inspector General signals an unprecedented warning that stricter oversight and enforcement are on the horizon for 2021 – and, frankly, the foreseeable future. 

Historically, Democratic administrations, beginning with President Clinton's, have indeed “followed the money” and focused on cracking down on healthcare fraud.  After billions of dollars in recoveries and corporate settlements over the past twenty years, the life sciences industry should brace itself for an unprecedent increase in regulatory oversight and enforcement under the Biden-Harris Administration. The war on healthcare fraud is both good politics and good economics, from a government perspective.  It demonstrates concerted government action to safeguard federal taxpayer dollars, concern for the most vulnerable in our society – the sick, the elderly, children and families -- holds crooks accountable, and all while recovering billions of dollars in settlements for the federal treasury.  Not a bad business model – if you are the government!  

After 100 days of the Biden Administration, all signs point to anti-fraud enforcement growing commensurate with the growth of federal dollars spent on federal healthcare programs.  The multiplier effects of the pandemic combined with new healthcare initiatives sought by the Biden-Harris administration that would inject billions of additional taxpayer dollars into the system all but guarantee that we will see, and perhaps appropriately so, a parallel, commensurate launch of a new era of healthcare fraud enforcement.  

Quite simply, these unprecedented times create unprecedented risks for fraud and abuse, and an associated need for accountability, oversight and enforcement.  As former Attorney General Dick Thornburg once shared with me back in the mid-90’s, when the DOJ makes any issue a priority, two things are guaranteed to happen:  more prosecutions and more convictions.  

As the national priority shifts to guiding a Covid-19 recovery, both medically and economically, the life sciences industry will remain in laser focus both nationally and globally. The takeaway: A lot of money is on the line, and life sciences companies need to take compliance very seriously if they want to stay ahead of the game in this fast changing, high-risk environment. 

Knowing this makes updating the risk profile of your ethics and compliance program more important than ever. If your organization doesn't have a plan to stay ahead of these developments, the time is now to develop one immediately. If you do have one in place, be sure to follow through with implementation. Additionally, it's paramount to stay vigilant and on top of new legislative, regulatory, and enforcement developments coming from the federal government as they are likely to be changing rapidly as new officials take their posts and start implementing new priorities to make their mark in the new Biden Administration. 

Staying fresh on current DOJ and OIG guidances and staying on top of newly or recently issued ones, such as the Special Fraud Alert on Speaker Programs, will help keep your business ahead of the curve. 

Getting compliance right is critical as risks are changing and growing. As businesses slowly open back up, there will be an added premium on communication, collaboration, and coordination among executives, compliance/privacy officers, and sales teams.  This will be how smart companies will win with compliance and avoid being caught in the crosshairs of federal investigators looking for targets of opportunity.  Investing to build and reinforce your company’s credibility and trust with regard to your commitment to compliance will be dollars well spent and pale by comparison to the cost of any whistleblower allegations or settlements.  

In short, the life sciences industry is booming with billions of dollars flowing in, giving rise to added compliance risks and enforcement. The new Biden administration, will recognize these added risks for fraud and abuse and meet it head on with a surge of enforcement actions.  A thoughtful compliance strategy will anticipate these added risks and position your company to continue to compete and win aggressively in the marketplace!  That’s what I call, winning with compliance!

If you're interested in better understanding new compliance risks and guidelines or enhancing your compliance program, contact me at [email protected] or 617-800-3704. Working with TRESTLE Compliance will help you develop a compliance action plan that will lead your company to commercial success!

Copyright ? Steve Vincze 2021 All rights reserved.

#compliance #trestlecompliance #lifescience #healthcare #risk #covid #futureofwork #pharmaceuticalsales #pharmaceuticalcompany #pharmaceuticalindustry #ethics #departmentofjustice