Health Care Enforcement: “Tea Leaves” in the 2024 National Health Care Fraud Summer Takedown
Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition.
The Justice Department’s 2024 National Health Care Fraud Enforcement Action Press Release, issued on June 27, 2024 surveys the DOJ’s 2024 summer sweep, involving criminal charges against 193 defendants, including 76 doctors, nurse practitioners, and other licensed medical professionals in 32 federal districts across the United States, for their alleged participation in various health care fraud schemes involving approximately $2.75 billion in intended losses and $1.6 billion in actual losses, by DOJ estimations.
The Center for Program Integrity of the Centers for Medicare and Medicaid Services (CPI/CMS) separately announced that it took adverse administrative actions in the prior six months against 127 medical providers for their alleged involvement in health care fraud. (The CPI/CMS actions, which include payment suspensions and billing privileges revocations, are not routinely reported by CMS or available to the public on any CMS database, and so it is not possible to ascertain their alignment with the DOJ actions identified above.) As noted in the CPI/CMS announcement, the summer enforcement action “is the direct result of close coordination among the Health Care Fraud Unit, U.S. Attorneys’ Offices across the country, State Attorneys General, Medicaid Fraud Control Units, and our law enforcement agency partners…including the U.S. Department of Health and Human Services Office of the Inspector General (OIG), FBI, Drug Enforcement Administration, and Homeland Security Investigations.”
The claims against the defendants are broadly based and do not seem to be overly focused on any health care sector or advocate for a prevailing legal theory. Nonetheless, in looking at DOJ’s National Health Care Fraud Enforcement Action Press Release and their history, there are “repeat occurrences” reflected among the DOJ-identified alleged misconduct. The cases provide some insight into DOJ’s workloads and priorities and may help providers identify areas of risk.
- Medical necessity is once again a popular enforcement theme. While there is a statutory requirement to support most claims for Medicare items or services, a failure to establish medical necessity can be a difficult theory to prove, often involving costly disputes among experts and wide variances in opinions. Indeed, in the civil False Claims Act context, appellate courts have dismissed cases where experts have disagreed about this issue. See, e.g., United States of America v. AseraCare Inc., 938 F.3d 1278 (11th Cir. 2019).
- Commercial insurance is identified as the victim entity in multiple actions. Other “non-traditional” alleged victims in the summer takedown include Amtrak and the Department of Energy. This focus is a reminder that providers should review and be confident in the integrity of their billing to all payers, not just to federal health care programs.
- Kickbacks to Medicaid patients are alleged in a few cases. DOJ and OIG appear to be continuing to analyze and distinguish those cases where intent is easier to prove (criminal) and those where intent is less obvious (civil monetary penalties or CMPs). For an interesting discussion of OIG’s views of the difference between the anti-kickback authorities (AKS) and the CMP relating to beneficiary inducements, see HHS-OIG’s General Questions Regarding Certain Fraud and Abuse Authorities.
- Adderall prescribing is the subject of several actions in California resulting from allegedly improper prescribing of this controlled substance. Some of the allegations relate to the use of telehealth — a continued additional focus of both DOJ and HHS.
- Lack of physician order for items or services, or lack of a physician–patient relationship, confirm the view of enforcement agencies that a physician or authorized equivalent must be demonstrated as a sufficiently involved gatekeeper to support Medicare coverage for claimed items and services. With health care evolving toward a more patient-empowered model (e.g., with patients identifying and requesting their own lab tests from commercially available test menus for tests that by law still require a clinician order), this theory is likely to continue as a lucrative area of focus for DOJ.
- Marketing alleged as kickbacks underscores that providing remuneration (directly or indirectly) for referrals continues to grab summer takedown headlines. It remains good practice to be certain that provider marketing arrangements meet AKS safe harbor elements.
- Patient protection, including in actions relating to drug diversion and “substandard care,” remains a top area of focus for both DOJ and HHS, both of which are on record as making patient protection an enforcement priority.
What Should Providers Do with This Information? As providers act on OIG’s Compliance Guidance to reexamine their risk assessment practices, the focus areas in DOJ’s summer sweep may suggest additional areas of risk to consider or address.
Want To Learn More?
- HHS OIG: New “General Compliance Program Guidance” Provides Voluntary Steps Towards Increased Effectiveness
- “Let’s Talk Compliance”: OIG’s General Compliance Program Guidance: How to Refresh Compliance Programs
Foley’s seasoned team of Health Care and Government Enforcement Defense & Investigations attorneys are monitoring the evolving and dynamic landscape of health care regulatory, criminal, and civil enforcement.
Foley is here to help you address the short and long-term impacts in the wake of regulatory and litigation changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group and Government Enforcement Defense & Investigations Practice Group with any questions.
