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
8/16/2024
/ American Bar Association (ABA) ,
Audits ,
Bribery ,
Corporate Misconduct ,
Corruption ,
Department of Justice (DOJ) ,
Financial Institutions ,
Forfeiture ,
Fraud ,
Incentives ,
Non-Prosecution Agreements ,
Pilot Programs ,
Voluntary Disclosure ,
Whistleblower Awards ,
Whistleblowers ,
White Collar Crimes
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
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
3/21/2024
/ American Bar Association (ABA) ,
CFTC ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Foreign Corrupt Practices Act (FCPA) ,
Healthcare ,
Securities and Exchange Commission (SEC) ,
Self-Reporting ,
Voluntary Disclosure ,
Whistleblower Awards ,
Whistleblower Protection Policies ,
Whistleblowers ,
White Collar Crimes
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 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 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
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
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
2/15/2024
/ Compliance ,
Cooperation ,
Corporate Crimes ,
Corporate Misconduct ,
Corruption ,
Department of Justice (DOJ) ,
Due Diligence ,
Enforcement ,
False Claims Act (FCA) ,
Safe Harbors ,
Self-Disclosure Requirements ,
Settlement ,
Voluntary Disclosure ,
White Collar Crimes
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
2/9/2024
/ Antitrust Provisions ,
Compliance Manuals ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare ,
Investment ,
Investors ,
OIG ,
Private Equity Funds ,
Qui Tam
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
10/4/2023
/ Advisory Opinions ,
Billing ,
Carve Out Provisions ,
Clinical Laboratories ,
Competition ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
OIG ,
Physicians ,
Risk Management
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
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
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
2/13/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Fraud ,
OIG ,
Public Health Emergency ,
Telemedicine
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
2/13/2023
/ Cyber Crimes ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Electronic Protected Health Information (ePHI) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Long-Term Care ,
Private Equity Firms ,
Qui Tam ,
Settlement
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
12/21/2022
/ Coronavirus/COVID-19 ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Department of Veterans Affairs ,
Federal Health Care Programs (FHCP) ,
Healthcare ,
OIG ,
Payment Systems ,
Telehealth ,
TRICARE
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
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
8/1/2022
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CLFS ,
Clinical Laboratories ,
Department of Health and Human Services (HHS) ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part C ,
PAMA ,
Proposed Amendments ,
Reimbursements
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
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
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
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
2/11/2022
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
Nursing Homes ,
Pharmaceutical Industry ,
Pharmacies ,
Qui Tam ,
Telehealth
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
11/11/2021
/ Civil Monetary Penalty ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
False Claims Act (FCA) ,
Health Care Violations ,
Healthcare Fraud ,
OIG ,
Provider Self-Disclosure Protocol ,
Reporting Requirements ,
Settlement ,
Whistleblowers
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
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
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