Federal health and justice departments collaborate once more, a warning sign for healthcare contractors in the sector
The Justice Department (DOJ) and Health and Human Services (HHS) have relaunched a joint working group focused on healthcare fraud, aiming to increase government-initiated False Claims Act lawsuits through enhanced information sharing and data mining.
The renewed collaboration between the DOJ and HHS is expected to bring about a more active role for the Department of Justice in managing whistleblower-initiated False Claims Act lawsuits under the current administration. Companies should ensure their internal whistleblower reporting procedures, policies, monitoring, and auditing activities are properly tailored to the areas of focus.
The HHS-DOJ False Claims Act Working Group has announced six new priority enforcement areas, including Medicare Advantage, drug pricing, and manipulation of electronic health records. These focus areas reflect an intensified cross-agency collaboration that leverages data mining, findings from HHS and HHS-OIG reports, and aims to expedite investigations and payment suspensions based on credible fraud allegations.
The group is particularly focused on False Claims Act enforcement, with a goal to root out waste, fraud, and abuse, particularly in government spending and taxpayer dollars. The focus areas include:
- Medicare Advantage fraud: The working group will scrutinize any fraudulent activities related to Medicare Advantage plans, which provide an alternative way for individuals to receive their Medicare benefits.
- Pricing issues related to drugs, devices, and biologics: The working group will investigate discounts, rebates, service fees, formulary placement, and price reporting, ensuring that these practices do not result in overcharges or underpayments to the government.
- Violations that create barriers to patient access to care: The working group will examine network adequacy requirements and other practices that may limit patients' access to necessary healthcare services.
- Kickbacks involving drugs, medical devices, durable medical equipment, and other federally paid healthcare products: The working group will target illegal remuneration or kickbacks paid to healthcare providers to encourage increased prescription of certain medicines or procedures, if those drugs or services are reimbursed by a federal health care program like Medicare or Medicaid.
- Issues with materially defective medical devices affecting patient safety: The working group will focus on ensuring the safety and efficacy of medical devices, investigating any devices that pose a risk to patients.
- Manipulation of electronic health records to drive inappropriate utilization of Medicare-covered products and services: The working group will scrutinize any manipulation of electronic health records that may lead to unnecessary or inappropriate Medicare billing.
In addition to these specific focus areas, the working group targets broader enforcement priorities such as combating discriminatory practices (including those related to gender-affirming care) and protecting women and children from improper practices.
General counsel of life sciences or healthcare companies should study the working group's stated enforcement priorities and tailor their compliance resources accordingly. Companies should assess whether their existing compliance programs are properly tailored to identify and remediate problems in the focus areas. The focus areas of the working group's enforcement priorities are expected to remain a focus for the next four to eight years.
[1] HHS-DOJ Health Care Fraud Working Group Announces Six New Priority Enforcement Areas [2] HHS-DOJ Health Care Fraud Working Group Announces Six New Priority Enforcement Areas [3] HHS-DOJ Health Care Fraud Working Group Announces Six New Priority Enforcement Areas [5] HHS-DOJ Health Care Fraud Working Group Announces Six New Priority Enforcement Areas
- The reimagined workforce in the federal workforce, particularly those in the healthcare and life sciences sector, should pay heed to the announced priority enforcement areas by the HHS-DOJ Health Care Fraud Working Group.
- With the intensified focus on healthcare fraud, companies in the medical-conditions and health-and-wellness industries need to ensure that their finance and business practices comply with the regulations regarding Medicare Advantage, drug pricing, and electronic health records manipulation.
- As the HHS-DOJ Health Care Fraud Working Group continues its efforts to root out waste, fraud, and abuse, firms must keep a close eye on enforcement priorities related to kickbacks, discriminatory practices, barriers to patient access, and safety concerns for medical devices.
