Despite the numerous pivots in the Department of Justice's focus over the past year, one priority remains constant: identifying “waste, fraud, and abuse, including health care fraud and federal program and procurement fraud that harm the public fisc.” Indeed, the Criminal Division identified this as its No. 1 priority last year. Subsequently, DOJ announced the formation of a DOJ-HHS False Claims Act Working Group signaling a coordinated, cross-agency approach with the Department of Health and Human Services (HHS) to rooting out fraud in federal healthcare programs.

One reason for this sustained focus is the sheer extent of recovery in this sector. The DOJ reported a record $6.8 billion in False Claims Act settlements and judgments in Fiscal Year 2025. Health care-related FCA matters accounted for the overwhelming majority of those recoveries — over $5.7 billion — underscoring the importance of robust compliance programs for health care providers and entities participating in federal health care programs.

Key enforcement areas that have drawn particular attention include Medicare Advantage fraud and managed care issues, such as unsupported diagnosis codes and kickback-driven enrollments; prescription drug fraud in pharmacies, encompassing pricing manipulation, copay assistance violations and dispensing without valid prescriptions; and allegations involving medically unnecessary services. Providers operating in any of these areas should be especially attuned to their compliance obligations and the heightened scrutiny they may face from federal enforcers.

CMS Requests for Information on Regulatory Changes

Building on these enforcement themes, the Centers for Medicare & Medicaid Services (CMS) and HHS have now issued a Request for Information (RFI) for feedback on potential regulatory changes aimed at strengthening program integrity. The RFI covers a broad range of topics that health care providers, suppliers and other stakeholders should carefully consider, including:

• Ways in which CMS can better prevent bad actors from engaging in fraud, waste and abuse, such as modifying provider enrollment, medical review, investigation, audit, payment suspension and other program integrity oversight policies;
• Expansion of CMS’s capabilities to address and prevent fraud in the Medicaid and CHIP programs as well as the Federally Facilitated Exchange (FFE) and State-based Exchanges (SBEs);
• Enhancements in identity proofing of individuals associated with Medicare-enrolled entities, including the potential imposition of citizenship or legal U.S. residency requirements for ownership;
• Ways to better effectuate the preclusion list in Medicare Advantage billing;
• How CMS can more effectively prevent fraud, waste and abuse in lab tests, particularly genetic testing and molecular diagnostic tests;
• Solutions for preventing non-participating Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) suppliers from fraudulently billing Medicare Advantage plans, as well as expansion of the current prohibition on unsolicited outreach by DMEPOS suppliers to Medicare beneficiaries to other types of providers and suppliers;
• Impact of CMS potentially reducing the one-calendar-year claim filing deadline for Medicare Parts A and B;
• How AI solutions can assist with accurately and effectively improving medical coding and billing; and
• Improvements in the methods by which Medicare beneficiaries can communicate with CMS or the Office of Inspector General regarding potentially suspicious Medicare claims.

The deadline to submit comments in response to the RFI is March 30. Health care providers, suppliers and other industry stakeholders should carefully review the RFI and consider whether to submit comments that could shape future regulatory policy.

Organizations operating in the health care space should also take this moment to evaluate the sufficiency of their existing compliance programs in light of DOJ’s record-setting enforcement activity and the government's clear signal that health care fraud will remain a top priority. Proactive investment in compliance infrastructure — including internal auditing, coding accuracy, enrollment controls and anti-kickback safeguards — can help organizations mitigate enforcement risk and position themselves favorably in an environment of heightened government scrutiny.

Miles & Stockbridge’s compliance lawyers are available to review your programs and strengthen compliance infrastructure.

Opinions and conclusions in this post are solely those of the authors unless otherwise indicated. The information contained in this blog is general in nature and is not offered, and cannot be considered, as legal advice for any particular situation. The authors have provided the links referenced above for information purposes only and, by doing so, do not adopt or incorporate the contents. Any federal tax advice provided in this communication is not intended or written by the authors to be used, and cannot be used, by the recipient for the purpose of avoiding penalties which may be imposed on the recipient by the IRS. Please contact the authors if you would like to receive written advice in a format which complies with IRS rules and may be relied upon to avoid penalties.