Articles and Blogs

On June 27, 2023, the Federal Trade Commission (“FTC”), in concurrence with the Antitrust Division of the Department of Justice (“DOJ”), announced plans to publish a 133-page Notice of Proposed Rulemaking (“Notice”) to amend and overhaul the Hart-Scott-Rodino Form and Instructions. The Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, requires all persons contemplating certain…Read More

On June 6, 2023, the U.S. Food and Drug Administration (“FDA”) released draft guidance (“Draft Guidance”) updating Good Clinical Practices (“GCPs”) recommendations for interventional clinical trials involving human subjects. The Draft Guidance, which is aimed at enabling the incorporation of rapidly evolving technological and methodological innovations into clinical trials, is adapted from the International Council…Read More

A new Indiana law imposes several written disclosure requirements that health facilities must provide to prospective residents. This new Indiana law (“Indiana Memory Care Law”) also includes requirements to follow when developing and executing a resident care plan.  The Indiana Memory Care Law requires an Indiana housing with services establishment that offers memory care services…Read More

In the latest effort to increase price transparency and lower prescription drug costs, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule (“Proposed Rule”) that, in part, intends to reveal the actual cost of drugs covered by Medicaid. The Proposed Rule includes two new initiatives: A Medicaid managed care organization (“MCO”) transparency…Read More

On June 5, 2023, the Centers for Medicare & Medicaid Services (“CMS”) implemented a national skilled nursing facility (“SNF”) probe and educate program (“SNF P&E Program”). The SNF P&E Program is designed to reduce improper payments by identifying SNFs with high improper payment rates. Recently, CMS’s Comprehensive Error Rate Testing program projected an improper payment rate…Read More

AdventHealth has exited the nursing home business, selling all 10 of its SNFs to third-party operators. Eight of the facilities were located in Florida, one was in Texas and one was in Kansas. The health care facility management industry is poised for significant growth according to a recent report. Health care facility management revenue is…Read More

On June 16, 2023, the U.S. Supreme Court decided United States ex rel. Polansky v. Executive Health Resources, Inc. The Court’s opinion settles two outstanding questions about the authority of the Government to dismiss FCA actions in which it first declines to intervene but that whistleblowers continue to pursue on the Government’s behalf. First, the…Read More

The Department of Labor’s Wage and Hour Division (the “WHD”) recently issued an opinion letter on May 30, 2023. This opinion letter clarifies how to calculate the amount of leave used under the Family and Medical Leave Act (“FMLA”) when an employee takes FMLA leave for less than a full week during a week that…Read More