Author: WadeEmmert

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Health Law Highlights

Fifth Circuit Grants Motion Relating to New CMA Compensation Rule

Summary of article from Troutman Amin, LLP, by John H. Henson:

On July 3, 2024, the US District Court of Northern Texas issued a Memorandum Opinion and Order in the combined cases challenging new CMS rules regarding compensation for Medicare Advantage and Part D plans. The court found the compensation changes to be arbitrary and capricious, granting a partial stay on these rules but allowing the consent requirement for sharing beneficiary data to proceed. The decision highlights the court’s scrutiny of the CMS rulemaking process and indicates a substantial likelihood of the plaintiffs’ success on the merits. However, the consent requirement remains in effect, necessitating prior express written consent for data sharing between third-party marketing organizations. This ruling does not impact the FCC’s 1:1 consent requirement, which remains distinct and unaffected.

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Health Law Highlights

Whether “Willful” Under the Anti-Kickback Statute Requires Knowledge that the Conduct is Unlawful

Summary of article from Mintz, by Laurence J. Freedman, Laura E. Martin:

The Supreme Court has the opportunity to clarify the definition of “willfulness” under the Anti-Kickback Statute (AKS) in a case involving McKesson Corporation. The Second Circuit upheld the dismissal of a False Claims Act (FCA) case, ruling that “willfulness” under the AKS requires the defendant to know their conduct is unlawful. The petitioner, Adam Hart, argues that this interpretation is too stringent and seeks Supreme Court review to resolve a circuit split on the issue. The outcome could significantly impact the Department of Justice and relators’ ability to prove AKS violations as predicates for FCA claims. The case has attracted significant interest from various industry and legal groups, anticipating potential Supreme Court involvement.

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Health Law Highlights

Judge Temporarily Blocks Biden Administration’s Restoration of Transgender Health Protections

Summary of article from AP News, by Devna Bose:

A federal district court judge has temporarily blocked parts of a Biden administration rule that would prevent insurers and medical professionals from denying hormone therapy and gender transition surgeries for transgender individuals. Judge Louis Guirola Jr. ruled in favor of 15 states, arguing that the 1972 Title IX nondiscrimination law pertains to biological sex rather than gender identity. This nationwide injunction affects the Affordable Care Act rule, which was set to take effect soon. The decision marks another setback for the Biden administration’s efforts to expand anti-discrimination protections, following recent judicial blocks on rules aimed at protecting LGBTQ+ students under Title IX. The ruling has prompted mixed responses, with some states arguing financial and ideological burdens.

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Health Law Highlights

FTC Seeks to Secure First Disgorgement in Nearly a Decade

Summary of article by Womble Bond Dickinson (US) LLP:

The FTC announced that Cardinal Health, Inc. has agreed to pay $26.8 million to settle allegations of anticompetitive behavior, marking the agency’s first disgorgement in a competition case in nearly a decade. The Complaint, filed in the Southern District of New York, accuses Cardinal of monopolizing the radiopharmaceuticals market by securing exclusive distribution rights to essential heart perfusion agents from Bristol-Myers Squibb and General Electric, thus impeding competition in 25 geographic markets. The Commission’s decision to pursue disgorgement was narrowly approved by a 3-to-2 vote, with dissenting Commissioners arguing insufficient evidence of antitrust violations and lack of clear guidance on disgorgement policies. Traditionally reserved for severe antitrust breaches like price fixing, this use of disgorgement could signal a shift in enforcement strategies, though it may also be specific to the unique circumstances of this case. The settlement awaits federal court approval.

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Health Law Highlights

Healthcare Execs Face Federal Drug Charges in Landmark Telehealth Case

Summary of article from Bradley Arant Boult Cummings LLP, by Jonathan Ferry, Stephen Moulton, Virginia Wright:

Federal prosecutors have charged two healthcare executives of Done Global Inc. and Done Health P.C., with unlawfully distributing controlled substances like Adderall via a telehealth platform. This unprecedented case highlights the Department of Justice’s focus on enforcing controlled substances laws within the digital health sector, particularly post-pandemic. The indictment alleges that Done exploited COVID-era regulatory waivers to facilitate easy access to ADHD medications without proper medical oversight, resulting in the unlawful distribution of over 40 million stimulant pills. This prosecution underscores the growing scrutiny of online prescription services and may set a precedent for future telehealth-related legal actions. The case raises critical issues regarding the balance between expanding access to mental health treatments and preventing prescription drug abuse.

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Health Law Highlights

Texas Retina Associates Cyberattack Affects 312,000 Patients

Summary of article from The HIPAA Journal, by Steve Adler:

A cyberattack on Texas Retina Associates, the largest ophthalmology practice in Texas, has compromised the sensitive data of 312,867 patients. The breach, which occurred from October 8, 2023, to March 27, 2024, exposed personal information including names, addresses, Social Security numbers, and medical details. Texas Retina Associates has since secured its systems, enhanced cybersecurity measures, and provided additional training to its staff. Notifications are being issued to affected individuals as a precaution, and a helpline has been established for further assistance. The practice has not mentioned offering complimentary credit monitoring or identity protection services.

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Health Law Highlights

Report Reviews Updates on Health Cybersecurity and Ransomware

Summary of article from Robinson & Cole LLP, by Linn F. Freedman:

The Health Sector Cybersecurity Coordination Center (HC3) has recently issued two critical alerts for the healthcare sector. The first alert, dated June 18, 2024, concerns Qilin (also known as Agenda Ransomware), a ransomware-as-a-service (RaaS) that targets healthcare organizations through spear phishing and other tools, employing double extortion tactics. The second alert, issued on June 27, 2024, highlights a critical vulnerability in the MOVEit file transfer platform, urging healthcare organizations to promptly patch the identified improper authentication processes to prevent exploitation. Progress, the platform’s owner, has released patches, but the vulnerability remains actively targeted by cyber threat actors. HC3 emphasizes the urgency of addressing these threats to protect against data loss and compromise.

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Health Law Highlights

Why Are Primary Care Physicians Optimistic About AI?

Summary of article from MedCity News, by Katie Adams:

Primary care physicians are optimistic about AI’s potential to enhance care delivery efficiency, particularly through automated dictation and scribing tools, which have significantly reduced administrative burdens. A survey by Elation Health revealed that nearly 70% of primary care clinicians believe AI will be crucial for future healthcare efficiency. The key advantage of AI is its ability to decrease “pajama time,” allowing physicians to spend more time with patients. Phill Tornroth from Elation Health emphasized that AI should augment, not replace, clinicians by integrating seamlessly into their workflows. This approach aims to enhance the physician-patient relationship, which remains central to effective primary care.

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Health Law Highlights

Biden Administration Tells Doctors They Must Provide Emergency Abortions

Summary of article from AP News, by Amanda Seitz, Christine Fernando:

In response to a recent Supreme Court ruling, the Biden administration has directed emergency room doctors to perform emergency abortions when necessary to save a pregnant woman’s health, emphasizing compliance with the Emergency Medical Treatment and Active Labor Act (EMTALA). This follows the Supreme Court’s failure to clarify whether state abortion bans override this federal law. The administration’s guidance aims to address reports of pregnant women being denied emergency care due to legal uncertainties. Enforcement will resume in Idaho, but remains on hold in Texas due to ongoing legal challenges. Additionally, the administration is enhancing resources for patients to file complaints against hospitals that fail to provide required emergency care.

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Health Law Highlights

How the Chevron Doctrine’s Overturn Could Effect Public Health, FDA

Summary of article from The Washington Post, by David Ovalle, Joel Achenbach, Rachel Roubein:

Recent Supreme Court decisions have significantly curtailed the power of federal health-care agencies, leading to potential challenges in regulating drugs, tobacco products, and medical technologies. The court’s ruling in Loper Bright Enterprises v. Raimondo overturned the Chevron doctrine, which had required courts to defer to agency interpretations of ambiguous laws, thereby increasing judicial scrutiny over agency decisions. This shift is expected to result in extensive litigation, complicating the administration of health programs like Medicare and Medicaid and potentially undermining public health protections. Legal experts warn that these changes could hinder the ability of agencies like the FDA to respond effectively to health emergencies and regulate emerging technologies. The Biden administration and health officials express concern over the long-term impact on public health and regulatory stability.