Would your practice's corporate compliance program pass the test?
Radiology continues to draw government scrutiny, for better or for worse. We have written in previous columns that diagnostic imaging centers particularly have fallen under the spotlight of investigators and prosecutors (see "Beware of Those Bearing Gifts," in the June 2013 issue, at http://bit.ly/JuneRADLAW).
And yes, other specialties, such as cardiologists and orthopedic surgeons, also have received enforcers' attention. However, a recent whistleblower case reinforces that ACR members must comply with numerous laws and regulations — or risk losing money and credibility.
The former owners of New York-based Imagimed, LLC, William B. Wolf III and Timothy Greenan, MD, and the company's former chief radiologist, Steven Winter, MD, have agreed to pay the United States over $3.5 million. The company and individuals are settling the government's allegations that they submitted false claims for MRI services to federal health care programs, violating the federal False Claims Act (FCA). Imagimed owned and operated 15 MRI imaging facilities, primarily in New York state, under the business name Open MRI.
The government alleged that for virtually seven years, Imagimed, its former owners, and Winter submitted claims to Medicare, Medicaid, and TRICARE for MRI studies performed with contrast without a qualified physician providing direct supervision. As noted in prior columns, Medicare requires that a physician supervise contrast-based studies, including MRI and CT.
Additionally, the government maintained that the defendants submitted claims for services referred to Imagimed by physicians with whom the company had inappropriate financial relationships. For almost three years, Imagimed purportedly engaged in fictitious on-call arrangements, provided free prior-authorization services, and gave various gifts to select referring physicians. This conduct allegedly violated the federal anti-kickback statute and the Stark self-referral law.
This case came to light when a local radiologist, Patrick J. Lynch, MD, filed a whistleblower lawsuit. The U.S. Attorney's Office in New York state eventually joined and took over the action. Lynch will receive over $560,000 as part of the settlement. Other key enforcement players included central Department of Justice branches in Washington and the HHS Office of Inspector General (OIG).
What does this case mean to you and your practice? This is yet another example of the government aggressively pursuing fraud and abuse charges against physicians, including radiologists and radiation oncologists. Federal authorities particularly have raised the stakes on supervision cases. Prosecutors more frequently use the FCA's steep penalties against imaging centers and radiologists, alleging that they violated the law by failing to meet applicable supervision requirements. Cases that previously went through OIG's administrative authorities now appear in federal court.
You also should note that the government wielded the federal anti-kickback statute to target on-call arrangements and preauthorization services. At press time, the U.S. Attorney's Office had not released details of the parties' settlement. However Imagimed — specifically Greenan, Winter, and Wolf — apparently offered improper items of value to referring clinicians. While the OIG has issued several advisory opinions in which it did not penalize certain free preauthorization arrangements, the Imagimed scheme may have fallen outside any anti-kickback "safe harbor." Hospital-based radiologists must understand that any on-call arrangement they negotiate with their hospital and clinicians might get the government's attention.
How can you and your practice prevent — or at least minimize the risk of — an Imagimed-like situation? Adopt and maintain a corporate compliance program. Read and share with colleagues the OIG's model compliance guidance for individual physicians and practices. Available at http://oig.hhs.gov/authorities/docs/physician.pdf, this document describes seven components for establishing an effective voluntary compliance program.
Each component matters to ACR members because all seven fit together. More important, the government will evaluate whether your practice's compliance program includes all seven components.
We recommend that radiologists and radiation oncologists especially focus on conducting an internal audit, holding relevant training and education, and putting teeth into their compliance program. Why? Any radiologist practice — small or large, urban or rural — can achieve these three steps. A baseline audit should reflect whether your practice has current and accurate standards and procedures. The baseline and periodic audits must answer this key question: Are your employees doing their jobs well and submitting appropriate claims? All compliance programs should motivate ACR members to learn what they do not know and refresh what they have learned.
By Bill Shields, JD, LLM, CAE, and Tom Hoffman, JD, CAE