We have spent a lot of time talking about ways to improve your compliance program on this blog: from best practices and recommendations from the OIG, to using EPStaffCheck to make your monthly compliance checks a breeze. One thing we haven’t really hit too hard yet though, is the worst case scenario when a mistake is made and your organization discovers a hole in your compliance monitoring program.
In this blog post we’ll highlight the steps a research hospital in Florida took to self-disclose improper claims they submitted from 2014-2020 for certain patient care items and services provided during research studies that were not eligible for reimbursement to the government. While the hospital was still fined by the OIG and Florida HHS, the important note here is that without self-disclosure and cooperation the end result would have been much worse.
Compliance Monitoring at Moffitt
From 2014 to 2020, the H. Lee Moffitt Cancer Center & Research Institute Hospital (Moffitt), a non-profit cancer treatment and research center based in Tampa, Florida, submitted claims to Medicare and other federal healthcare programs for services that were not reimbursable under Centers for Medicare and Medicaid Services rules governing reimbursement for clinical care provided in connection with clinical research trials. After learning of these issues, Moffitt began an independent investigation and compliance review, then they voluntarily provided the government with a written disclosure of its findings. Moffitt cooperated fully with the government’s investigation of the conduct and implemented prompt and substantial remedial measures.
“Healthcare providers participating in federal healthcare programs must ensure that they comply with applicable rules and regulations, including those relating to the submission of claims in connection with clinical research,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “As today’s settlement reflects, when providers run afoul of their obligations, they can mitigate the consequences by making timely self-disclosures, cooperating with investigations and taking appropriate remedial measures.”
The end result of the investigation was that Moffitt agreed to pay $19.5 million to resolve its civil liability under the False Claims Act. Despite the hefty price tag of the resolution, Moffitt was not excluded or sanctioned by the OIG, Florida Medicaid, or any other federal/state agency.
Moffitt provides a wonderful example for all organizations on how to ultimately handle a situation in which your organization makes the unfortunate discovery that they have run afoul of compliance laws and/or recommendations. Investigate the problem, voluntarily disclose what was done to proper authorities, cooperate with the government’s investigation, and, perhaps mostly importantly, implement swift and substantial remedial measures to ensure something similar does not happen again in the future.
Improve Your Compliance Program
To lower your chances of needing to self-disclose any compliance issues in the future, consider EPStaffCheck to help ensure your compliance monitoring program is comprehensive.
Click below for Self-Disclose forms/webpages: