Compliance

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Engaging in management and investor conversations about maintaining and growing a business is critical, no matter the industry. Whether you’re discussing normal business sustainability, organic growth, or contemplating a sale, these discussions become more complex when practicing physicians are the business’s revenue generators. These conversations must be handled carefully to comply with the spirit and letter of healthcare’s strict fraud and abuse laws. To ensure these discussions are both productive and compliant, it’s essential to navigate these complex regulations effectively.

In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning interpretations of ambiguous laws, as long as those interpretations were reasonable. This doctrine has been a cornerstone of administrative law, significantly impacting…

On February 8, 2024, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) finalized long-awaited modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 C.F.R. Part 2, which requires individuals or entities that receive federal funding and provide SUD treatment to implement additional privacy protections and obtain specific consent before using and disclosing SUD treatment records (see 42 C.F.R. § 2.11).

U.S. Senators Angus King (I-ME) and Marco Rubio (R-FL) recently introduced a bill addressing cybersecurity protections and oversight in the healthcare industry. The Strengthening Cybersecurity in Health Care Act, introduced on February 8, 2024, aims to bolster a vulnerable and often-targeted industry against cyberattacks. The proposal follows a number of significant cyberattacks on healthcare organizations in recent years; Senator King noted that approximately 133 million people, or nearly one in three Americans, had their personal information compromised in 2023 alone.

On November 6, 2023, the Office of Inspector General (“OIG”) issued its long-awaited General Compliance Program Guidance (“Guidance”) “to help advance the industry’s voluntary compliance efforts in preventing fraud, waste, and abuse in the health care system.” Although the Guidance is nonbinding, it reflects the OIG’s expectation that compliance programs become increasingly sophisticated in their approach to identifying and managing compliance risks as healthcare delivery and payment models continue to evolve.

Meg Pekarske Hospice Governance Academy

Hospice boards today need to be well-versed in a number of areas that directly or indirectly address legal issues. In this three-part Hospice Governance Academy Spotlight Interview, Bill Musick, President of Integriti3D, talks with Meg Pekarske, a partner at Husch Blackwell and host of the podcast, “Hospice Insights: The Law and Beyond…

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We previously outlined the requirements of the Hospital Price Transparency Rule (the “Rule”), which goes into effect January 1, 2021. See The Price Transparency Rule Goes Into Effect January 1, 2021 – Is Your Hospital Ready?  Since releasing that blog post, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision, ruling against the American Hospital Association and other hospital groups and upholding the District Court’s grant of summary judgement for the Department of Health and Human Services (“HHS”).  Among its allegations, the American Hospital Association had contended that the Rule exceeded HHS’ statutory authority, violated the First Amendment, and was arbitrary and capricious under the Administrative Procedure Act.

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The FDA could approve two COVID-19 vaccines within a matter of days. However, drug makers have tried to keep expectations in check about how much vaccine they can deliver immediately and over the next few months as they grapple with supply chain and manufacturing challenges. In Safety Law Matters, we write about limited and…

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In this episode, Husch Blackwell’s Meg Pekarske is joined by colleague Stephanie Kaiser for a rich conversation on what it means for a hospice board to carry out its fiduciary duties and how this relates to the role and responsibilities of hospice executives. Through counseling and training boards across the country, Stephanie has gained unique insights on the inner workings of boards, and breaks down what good governance looks like in action. Stephanie debunks common misconceptions on what defines a “good” board and provides practical tips on how hospice executives can and should engage and inform their boards. We also discuss when boards and individual members are liable and how to guard against such claims.