In the past month, the U.S. Attorney's Office for the Middle District of Florida--the primary federal law enforcement authority in Central Florida--has announced a series of healthcare-fraud related developments. These developments are an ominous sign of ramped-up enforcement in the region.
For example, in late March, the U.S. Attorney's Office announced that it was joining a healthcare fraud lawsuit against Central Medical Systems, LLC (Central Medical), the national leader in medical supply equipment for wound care, which has its global headquarters in Orlando. In a press release, the Department of Justice (DOJ) alleged that Central Medical used its software to manipulate orders, thereby billing "Medicare for thousands more products than it had purchased." The lawsuit was originally filed by a whistleblower, but DOJ is now actively prosecuting the matter.
Less than a week later, the office announced that it successfully convinced a court to order an Orlando-based company to stop distributing drugs that purportedly could help treat or prevent a host of serious conditions or diseases. According to the press release, the Orlando company (MyNicNaxs LLC) made claims about its drugs even when those claims were not rooted in science.
These two civil prosecutions in the past month underlie a far more significant fact: DOJ is continuing to aggressively identify and prosecute healthcare providers for perceived fraud. And nowhere is this focus growing more sharply than in Central Florida. Just last year, DOJ added a dedicated healthcare fraud prosecutor to the Orlando area, precisely because of concerns of growing fraud.
This additional scrutiny, in many ways, is justified. As readers will know, healthcare expenditures in this country have been growing precipitously and some estimates now suggest that healthcare constitutes one-sixth of the nation's economy. A large source of that spending growth is driven by healthcare fraud, waste, and abuse.
To be sure, the vast majority of healthcare providers are honest, hardworking, and ethical. It is a very small percentage of providers--perhaps, less than one percent--that fall within the ambit of prosecutors' watchful eyes. But, for these unscrupulous few, DOJ continues to be focused on healthcare prosecutions.
While DOJ continues to do its job in enforcing the myriad of healthcare rules and regulations, providers would be well-served by reviewing their internal procedures and compliance controls before DOJ comes knocking. Whether you are a durable medical equipment provider, a pharmacy, a healthcare provider, or any other regulated party, the time for internal due diligence is now. Some practical suggestions include:
- Carefully review your billings to the federal healthcare programs, such as Medicare, Medicaid, and TRICARE, over the past few years. Look at the data both on an individual and aggregate level. If there are sudden spikes or new procedures being billed, make sure you can explain those changes and the medical necessity for these new procedures.
- Review your agreements with outside vendors, ancillary providers, and other third parties. Make sure that the agreements comply with the Stark Law and the Anti-Kickback Statute. In particular, providers should ensure that these arrangements are rooted in fair-market values and are not designed to steer or induce referrals of federal healthcare program business.
- Periodically make sure that your employees are trained about basic compliance--cover issues such as HIPAA privacy protections, the need be vigilant about potential kickbacks, and similar topics. Compliance training is rarely fun, but it is always important. Keep compliance training fresh and relevant. And make sure employees know that they will be rewarded, not punished, for reporting potential problems to management.
- Lastly, make sure you familiarize yourself with the many regulations that govern healthcare. Modern medicine--particularly when dealing with the federal government payors such as Medicare or Medicaid--is an immensely regulated profession. Providers, whether they be doctors, nurses, or even administrative officers, would be well-served by reviewing the applicable rules and making sure that they are fully in compliance.
As former prosecutors, we commend our former colleagues for their pursuit of unscrupulous actors. We know, first-hand, that the work of law enforcement is critical. We also know that most healthcare practitioners are ethical and honest. Ultimately, by performing internal due diligence before regulators ask questions, providers can best defend themselves and prevent unwanted protracted investigations. While internal compliance is sometimes viewed as an unwanted expenditure of time and resources, in this age of highly regulated medicine, an ounce of prevention is worth a pound of cure.
Republished with permission. This article first appeared in the Orlando Medical News on April 9, 2018.