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DOJ Issues its Highly Anticipated Whistleblower Awards Pilot Program

In March 2024, at the American Bar Association’s 39th National Institute on White Collar Crime, Deputy Attorney General (“DAG”) Lisa Monaco announced that the Department of Justice (“DOJ” or the “Department”) intended to...more

A Mintz Health Care Roundtable: Current Trends in State Health Care Transaction Review and What to Expect in 2024

States are increasingly exercising regulatory oversight of health care transactions by enacting laws requiring prior notice or approval of certain health care transactions. Currently, 15 states have enacted health care...more

DOJ Announces it is Designing a Whistleblower Rewards Program

In early March 2024 at the American Bar Association’s 39th National Institute on White Collar Crime, Deputy Attorney General (DAG) Lisa Monaco’s keynote remarks previewed the development of new and significant Department of...more

FTC Hosts Panel and Launches Public Inquiry with DOJ and HHS on Private Equity and Health Care

As part of the Biden administration’s State of the Union blitz, the Federal Trade Commission (FTC) convened a workshop on private equity (PE) investments in the health care industry on March 5, 2024. Immediately prior to the...more

California Bill (AB-3129) Targets Private Equity and Hedge Fund Health Care Transactions

California Attorney General Rob Bonta (AG) and Assembly Speaker pro Tempore Jim Wood recently introduced legislation (AB-3129) that would authorize the AG to review private equity group and hedge fund health care...more

California’s Health Care Transactions Review Law: Preparing for What Comes Next

California’s health omnibus trailer bill SB-184 and the final cost and market impact review (CMIR) regulations (CMIR Regulations), which went into effect on December 18, 2023, have ushered in a significant change in...more

Safeguarding Reproductive Rights

In a defining moment for reproductive rights in America, the Supreme Court’s decision in Dobbs v. Jackson Women's Health Organization (2022) marked a pivotal turning point. This ruling, revoking the constitutional right to...more

EnforceMintz — DOJ’s Efforts in 2023 to Incentivize Voluntary Self-Disclosure

2023 was a very active one for Department of Justice (DOJ or the “Department”) guidance, and that guidance had one clear theme: DOJ wants companies to voluntarily self-disclose their misconduct. To incentivize...more

EnforceMintz — Despite Few Enforcement Actions in 2023, PE Investment in Health Care Remains a Hot Topic

Private equity (PE) investment in the health care industry has grown significantly over the last decade. This past year was no exception. While total deal volume lagged behind 2021 record highs, PE health care deal activity...more

OIG Issues Advisory Opinion Nixing Purchased Services Arrangement Between Certain Anatomic Pathology Laboratories

Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase...more

OIG Issues Unfavorable Advisory Opinion on Common Arrangements between Physician Practices and Health Care Providers

On August 15, 2023, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a negative Advisory Opinion regarding a turnkey physician-owned entity (Newco) operated by an existing provider...more

CMS Proposes New Disclosure of Ownership Regulations for Nursing Facilities - Top Five Takeaways for Private Equity Firms and...

Private equity (PE) ownership of health care providers is unquestionably under scrutiny by federal and state regulators. States are passing laws that either directly or indirectly target PE health care transactions. For...more

EnforceMintz — With Telemedicine Here to Stay, Enforcement Agencies Continued their Scrutiny

The Department of Justice and other federal enforcement agencies continued to hotly pursue individuals and entities involved in criminal telefraud schemes in 2022, as evidenced by the national coordinated law enforcement...more

EnforceMintz Newsletter — Quick Hits

Record Settlement in a Declined Case - While defendants typically breathe a sigh of relief when the Department of Justice (DOJ) declines to intervene in a qui tam False Claims Act (FCA) case, a more favorable outcome is by...more

OIGs Report on Expanded Telehealth Service Access and Use, Program Integrity Risks During Year One of COVID-19 Pandemic

The Pandemic Response Accountability Committee (PRAC) Health Care Subgroup recently published an expansive report that highlighted the sheer volume of expanded access to and use of telehealth services in certain federal...more

New York Office of Medicaid Inspector General Proposes Regulations on Self-Disclosure Program

This post is the third and final installment of our blog series on the proposed regulations published by the New York State Office of Medicaid Inspector General (OMIG). The proposed regulations would repeal the current Part...more

PAMA Laboratory Reporting In Flux: ACLA Wins HHS Lawsuit and Congress Introduces PAMA Amendment Legislation

Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory...more

Two Recent False Claims Act Settlements Highlight the Benefits of Self-Disclosure, Remediation, and Cooperation

Disclosing known or suspected fraud to regulators can have its benefits. As reported in a previous post, the Department of Justice (DOJ) issued policy guidance in 2019 on providing credit in False Claims Act (FCA)...more

OIG Expresses Concern about Laboratory Specimen Collection Payments to Hospitals in AO 22-09

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a...more

OIG Approves Manufacturer’s Offer of Free Genetic Testing

The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a...more

Health Care Enforcement Year In Review & 2022 Outlook

STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more

OIG Revises and Renames the Provider Self-Disclosure Protocol

For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other...more

Five Takeaways from DOJ’s Latest National Enforcement Action, Including Continued Focus on Opioids and Telemedicine

The U.S. Department of Justice (DOJ) recently announced its latest national enforcement action related to health care fraud (National Enforcement Action) in which DOJ filed criminal charges against 142 defendants. The...more

Combatting Patient Leakage by Directing Physician Referrals: What is Permitted under the Stark Law?

For many health care systems, patient leakage – when patients leave a health care system’s network in favor of out-of-network providers – is a rampant problem that results in substantial lost revenue. While sometimes patient...more

Panel Discussion Among Government Lawyers Provides Key Insights into the Future of FCA Enforcement

During a recent panel discussion hosted virtually by the American Bar Association, attorneys from the Department of Justice (DOJ) and certain U.S. Attorneys’ Offices known for health care fraud enforcement provided valuable...more

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