HHS-OIG issued a new Special Fraud Alert on relationships with “purported telemedicine companies” on July 20, 2022. The Special Fraud Alert comes on the heels of a nationally coordinated takedown charging dozens of individuals criminally for their participation in an allegedly fraudulent scheme related to telemedicine, laboratories, and durable medical equipment (“DME”). However, the alert comes after focus on telemedicine fraud cases in particular since 2019. The Special Fraud Alert identifies several characteristics of concern and common elements that individuals and companies should be aware of.
On November 4, 2021, the Department of Justice (DOJ) announced the conviction of several South Florida addiction treatment facility operators following a seven-week trial. The initial indictment was filed in September 2020, charging ten defendants for their alleged conduct in committing health care fraud, wire fraud, violations of the Eliminating Kickbacks in Recovery Act (EKRA), the Anti-Kickback Statute, and money laundering. The defendants included the co-owners of two entities providing treatment and therapy for substance use disorder, several other management level individuals, a referring chiropractor, and several marketing employees. …
Continue Reading DOJ Focused on Toxicology Testing – EKRA and Anti-Kickback Statute Violations Abound
On May 22, 2020 the U.S. Department of Health and Human Services (HHS) issued a 45-day extension of the deadline for providers who receive payments from the CARES Act Provider Relief Fund to accept the Terms and Conditions attached to such payments. Providers now have up to 90 days from the date a payment is received to accept the Terms and Conditions or return the funds to HHS. In its announcement, HHS reiterated its prior position that “Providers that do not accept the Terms and Conditions after 90 days of receipt will be deemed to have accepted the Terms and Conditions.”…
Continue Reading HHS Extends Compliance Deadline for Providers Receiving CARES Act Provider Relief Funds and Reminds Providers of June 3 Deadline Related to Additional Relief Fund Payments
On April 3, 2020 the Office of Inspector General (OIG) issued a Policy Statement to notify health care providers and other parties subject to the Anti-Kickback Statute (AKS) that the OIG will not impose administrative sanctions for potential AKS violations for COVID-19-related arrangements that are covered by some – but not all – of the Blanket Waivers of the Physician Self-Referral (Stark) Law issued on March 30 (see here for our analysis of the Blanket Waivers).
Continue Reading OIG Will Not Impose Administrative Sanctions for AKS Violations for Conduct Covered by Certain Blanket Waivers of the Stark Law
On March 24, 2020, the Department of Justice (DOJ) and Federal Trade Commission (FTC) issued a joint statement on COVID-19-related antitrust enforcement highlighting ways “firms, including competitors, can engage in procompetitive collaboration that does not violate the antitrust laws” to protect public health and safety. The DOJ and FTC emphasized their commitment to facilitating antitrust compliance for businesses that are responding to the national emergency. In furtherance of this position, the agencies gave examples of collaborative activities designed to improve health and safety during the COVID-19 pandemic that are unlikely to run afoul of the antitrust laws, absent exceptions. These include:
- Collaboration on research and development as “efficiency-enhancing integration of economic activity” which is typically procompetitive.
- Sharing technical know-how – rather than company specific data about prices, wages, outputs, or costs – as necessary to achieve procompetitive benefits of collaboration.
- The “development of suggested practice parameters – standards for patient management developed to assist providers in clinical decisionmaking” by providers will not be challenged except in extraordinary circumstances.
- Joint purchasing arrangements among health care providers “designed to increase the efficiency of procurement and reduce transaction costs.”
- “[P]rivate lobbying addressed to the use of federal emergency authority, including private industry meetings with the federal government to discuss strategies on responding to COVID-19, insofar as those activities comprise mere solicitation of governmental action with respect to the passage and enforcement of laws.”
On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company that resolves parallel criminal and civil investigations involving allegations of kickbacks, false claims, and non-compliance with federal EHR program requirements. We previously discussed a preliminary settlement in this case here, and in announcing the finalizing of that settlement the DOJ has shed more light on the allegedly improper conduct at issue. According to the DOJ, this is the first criminal action ever brought against an EHR company, and the “unique” deferred prosecution agreement (DPA) imposed by the DOJ against Practice Fusion that seeks “to ensure acceptance of responsibility and transparency as to” underlying conduct may reflect a new approach to settlements with corporate health care defendants.
Continue Reading DOJ Announces Settlement with EHR Company to Resolve Criminal and Civil Kickback Investigations Tied to Opioid Prescribing
On January 10, 2020, The Department of Justice (DOJ) and Federal Trade Commission (FTC) announced new draft vertical merger guidelines for public comment. Once finalized, the draft guidelines will replace the DOJ’s 1984 Non-Horizontal Merger Guidelines and describe how the FTC and the DOJ will analyze and enforce vertical mergers for compliance with the antitrust laws. Vertical mergers combine two or more companies operating at different levels of the same supply chain, e.g., a combination between a hospital and independent physician group, or a health system and a skilled nursing facility. The draft guidelines adopt common concepts from the Horizontal Merger Guidelines, such as the definition of a “market,” the framework for analyzing the sale of a failing business or its assets, and the purchase of partial ownership interests. Notably, and to the disappointment of many within the health care community, the draft guidelines provide little guidance on vertical mergers specific to the health care industry. Additionally, two FTC Commissioners abstained from voting on the draft guidelines and issued statements outlining their concerns that the guidelines are too lenient toward vertical mergers.
Continue Reading DOJ and FTC Announce Draft Vertical Merger Guidelines
On January 21, 2020, the Department of Justice (DOJ) announced a $3 million settlement with Patient Services, Inc. (PSI) to resolve allegations of False Claims Act (FCA) violations. The DOJ alleged that PSI enabled three pharmaceutical companies to pay kickbacks to patients by funneling money to patients taking drugs manufactured by those same pharmaceutical companies. In addition to the $3 million, PSI has entered into a three-year integrity agreement with Health and Human Services’s Office of the Inspector General. The settlement involved no determination of liability.
Continue Reading DOJ Reaches Settlement with Patient Assistance Foundation Resolving Allegations of FCA Violations
On November 26, 2019, the Department of Justice (DOJ) announced a $26.67 million settlement with a laboratory testing corporation, Boston Heart Diagnostics Corporation (Boston Heart). The settlement resolves allegations of False Claims Act (FCA) violations related to alleged payments for patient referrals in violation of the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (PSR Law) – commonly known as the Stark Law – and other improper billing.
Continue Reading DOJ Announces $26.67 Million Settlement with Laboratory to Resolve FCA Allegations
On November 15, 2019, the Department of Justice (DOJ) announced it had reached a settlement with Sutter Health (Sutter) and Sacramento Cardiovascular Surgeons Medical Group Inc. (Sac Cardio) to resolve alleged violations of the Physician Self-Referral Law (PSR Law), commonly known as the Stark Law. Sutter is a California-based health services provider; Sac Cardio is a Sacramento-based practice group of three cardiovascular surgeons. The total settlement in excess of $46 million includes $30.5 million from Sutter to resolve allegations of an improper financial relationship specific to compensation arrangements with Sac Cardio. Sac Cardio has agreed to pay $506,000 to resolve allegations of duplicative billing associated with one of these compensation arrangements. Separately, the settlement includes another $15,117,516 from Sutter to resolve self-disclosed conduct principally concerning the PSR Law.
Continue Reading DOJ Announces Physician Self-Referral (Stark) Law Settlement in Excess of $46 Million with California Health System and Surgical Group