On December 18, 2023, the Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (“DOJ”) issued a final version of their Merger Guidelines. Initially proposed in July 2023, after five months of public commentary and feedback and two years of work in total, the 2023 Merger Guidelines include 11 enforcement principles to support the Biden administration's more aggressive antitrust enforcement policies. Health care providers contemplating a merger should ensure the merger does not create a presumption of illegality or violate antitrust laws according to the Guide ..read more

As health care payers increasingly rely on artificial intelligence (“AI”) to speed up patient claim adjudication and prior-authorization determinations, providers should be on the lookout for algorithms designed to deny claims with minimal human oversight. Two putative class action lawsuits filed against Cigna and UnitedHealth in November 2023 allege that the payers’ respective AI models, “PxDx” and “nH Predict,” were used in place of real medical professionals to wrongfully deny medically necessary care. The lawsuit against Cigna alleges that Cigna uses its PxDx (procedure-to-diagnosis) algor ..read more

For the first time in 15 years, the Office of Inspector General (OIG) has issued updated compliance program guidance. The release of this guidance is part of the OIG’s two-step approach to modernize its current compliance program guidance. In April 2023, the OIG indicated that it would publish general compliance program guidance by the end of 2023 as the first step to modernizing its current guidance and would then publish industry-specific compliance program guidance for different types of providers, suppliers, and other participants in health care industry subsectors or ancillary industry se ..read more

Last week, the Office for Civil Rights (“OCR") released two new resources designed to assist patients in understanding the privacy and security risks to their health information associated with using telehealth, and steps that can be taken to reduce those risks. The first document provided by OCR is intended to serve as a resource for providers on how to educate their patients about these telehealth risks.  For example, the document describes how providers should explain what telehealth is to patients, the risks of malware, unauthorized access and accidental disclosures, and how to effect ..read more

Pumpkin spice is on all the shelves and the winter holidays are fast approaching.  But as we enter into the final few months of 2023, the health care industry should also remember to make note of and prepare for a number of changes that are expected to occur in late 2023 or early 2024.  Below we recap just a few of these items. OIG Compliance Program Guidance Updates  In April 2023, the HHS Office of Inspector General (“OIG”) announced its intention to modernize its compliance program guidance documents.  This includes publication of a General Compliance Program Guidance ..read more

On August 28, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published a new “Featured Topic” webpage on managed care oversight. The OIG’s Featured Topics include compilations of the OIG's existing work related to a specific subject matter area and are updated as new material is published. Due to the growth of managed care and the significant differences between fee-for-service and managed care programs, the OIG has designated oversight of managed care as a priority area and has developed a coordinated plan for managed care oversight (the “Managed Ca ..read more

There have been a number of changes to Form I-9 that employers should know. In a recent article, employment and immigration partner Carlos Ortiz laid out the changes and key dates relevant to Form 1-9 changes.   Read more here ..read more

At the intersection of law and business, ambiguity can present significant challenges. But one thing seems apparent under the False Claims Act (“FCA”) for health care entities submitting reimbursement claims to the government: if you subjectively believe that your claims are or might be false, you likely have the requisite intent to violate the FCA. And this principle may hold true even if there is technically some ambiguity about the facts underlying the representations inherent in presenting your claim to the government. On June 1, 2023, in U.S. ex rel. Schutte v. Supervalu Inc. and U ..read more

The Illinois legislature recently passed new antitrust legislation (“HB2222”) that will require advance notice to the Attorney General for health care facilities and health care provider entities engaging in certain covered transactions. If signed by the Governor, the new legislation will go into effect January 1, 2024.  HB2222 would provide the Attorney General with notice of all material health care facility transactions in Illinois, so-called “covered transactions”. A covered transaction, as defined in HB2222, is any merger, acquisition, or contracting affiliation between two or more ..read more

On April 20, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published a new toolkit  titled “Analyzing Telehealth Claims to Assess Program Integrity Risks” designed to analyze claims data for telehealth services and identify program integrity risks to Federal healthcare programs (“Toolkit”).   The Toolkit appears to be driven by the OIG’s concerns about the increased risk of fraud, waste, and abuse in connection with the recent explosion of telehealth utilization.  The Toolkit is intended to be used by public and private parties ..read more