The Health Care Fraud and Abuse Prevention Program (HCFAC), an annual report jointly published by the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS), predicts the Department's priorities for the coming year. Helpful. . At the 2022 HCFAC, the Department of Justice and the Department of Health not only highlighted a series of fraud and abuse enforcement victories, but also the U.S. Food and Drug Administration (FDA) and Department of Justice Consumer Protection Branch (CPB) It also suggested an increase in activity. The increased activity by these regulatory agencies should be of interest to stakeholders in the pharmaceutical and medical device sectors.
Background and purpose of HCFAC
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) established HCFAC to coordinate federal, state, and local law enforcement agencies with respect to health care fraud and fraud enforcement efforts. HCFAC offers a SportsCenter Top 10-style list of DOJ and his HHS enforcement highlights from the past fiscal year. It also reveals total recoveries and disbursements made as part of the U.S. government's ongoing efforts to combat health care fraud and abuse.
The enforcement results highlighted by the Ministry of Justice and the Ministry of Health were as expected. COVID-19-related fraud, opioids, and telemedicine (including, of course, deep dives into “brace yourself” operations) have all made headlines, with public statements promoted by the Department of Justice and Department of Health. reflects executive enforcement priorities. Years after the pandemic, representatives are still active.
However, this report reveals the impact of the pandemic not only on health-related enforcement activities, but also on the targets of such enforcement activities. Specifically, HCFAC's return on investment metrics indicate that DOJ and HHS are considering lower dollar targets.
The return on investment for enforcement-related spending at the Departments of Justice and Health declined from $4 to $2 for every dollar spent. This reflects the lingering financial effects still impacting the healthcare and life sciences industries and suggests the Department of Justice is taking enforcement actions against a wider variety of providers.
HCFAC identifies increase in FDA enforcement funding
In addition to these highlights, HCFAC also noted seemingly strategic funding increases for various HHS agencies from FY 2021 to FY 2022. The increase in funding that piques the interest of stakeholders in the pharmaceutical and medical device sectors is specifically for the FDA's Pharmaceutical Fraud Program (PFP).
Led by the FDA's Office of Criminal Investigation and the Food and Drug Administration, the purpose of the PFP is to investigate, prosecute, and prevent drug, biological, and medical device fraud under the Federal Food, Drug, and Cosmetic Act (FFDCA). ) and other laws and regulations. In fiscal year 2022, PFP initiated 16 investigations, including allegations of fraudulent new drug applications, violations of current good manufacturing practices, clinical trial fraud, and fraudulent marketing schemes.
From FY 2021 to FY 2022, the mandatory allocation of HCFAC funds to PFP nearly doubled to just under $12 million. Although there was no corresponding increase in the number of investigations initiated by the PFP (16 compared to 15 in FY 2021), the increase in funding is a strong support for his PFP's rigorous and thorough enforcement efforts. It shows. This additional funding will likely increase scrutiny and investigation in FY2023.
Evolving enforcement tools
The increase in funding for PFP may indicate that HCFAC is beginning to widen the government's avenues for prosecuting health care fraud and abuse matters. Traditional enforcement methods have significantly reduced post-pandemic recoveries, with False Claims Act (FCA) recoveries decreasing by more than $3 billion from fiscal year 2021 to fiscal year 2022.
Another section of the HCFAC suggests that the CPB is becoming a driving force in similar FFDCA-related and other consumer fraud investigations and prosecutions. According to the report, CPB nearly tripled its efforts in response to consumer fraud-related enforcement efforts, from 23,000 hours in fiscal year 2021 to nearly 65,000 hours in fiscal year 2022. On the other hand, the Department of Justice's enforcement under the FCA could always be the “Batman” for health care fraud and abuse. When it comes to enforcement, PFP and CPB appear to be positioned as formidable “robins”, especially for companies in the pharmaceutical and medical device sectors.
Combined with the OIG's ongoing fraud and fraud investigation and audit efforts, federal agency enforcement remains strong. The CPB's increased enforcement activity is consistent with recent comments from CPB Assistant Attorney General Arun Rao announcing the CPB's own M&A safe harbor policy.
Important points
The HCFAC report indicates that the Department of Justice and FDA may be expanding their enforcement tools given the recent decline in historically powerful fraud and abuse tools like the FCA. Masu. Healthcare professionals should look to increased funding to strengthen PFP and CPB efforts related to public health and safety and consider proactive steps to ensure regulatory compliance. Providers, suppliers, and manufacturers should heed the findings of his 2022 HCFAC report when conducting compliance-related activities.
