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Health Law Highlights

CMS Releases Proposed Rule on Anomalous DME Spending and MSSP Financial Calculations

Summary of article from American Hospital Association:

The Centers for Medicare & Medicaid Services (CMS) released a proposed rule to address significant, anomalous, and highly suspect (SAHS) billing activity affecting the Medicare Shared Savings Program (MSSP) financial calculations for 2023. CMS proposes excluding payment amounts for certain intermittent urinary catheter codes from expenditure and revenue calculations for 2023, impacting benchmarks for subsequent years and application cycles for new agreements starting in 2025. This decision follows advocacy from the AHA and others to relieve accountable care organizations (ACOs) from the financial burden of anomalous spending beyond their control. CMS has initiated a 30-day comment period, ending July 29, to ensure minimal disruption to ACO timelines. The AHA supports this move and anticipates further measures in the upcoming CY 2025 Physician Fee Schedule to address anomalous spending comprehensively.

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Health Law Highlights

Texas Supreme Court Upholds Ban on Youth Gender Transitions. It’s the Largest State With Such a Law

Summary of article from AP News, by Jim Vertuno, Andrew Demillo:

The Texas Supreme Court upheld a state law banning gender-affirming medical care for transgender minors, rejecting parental pleas that it violates their rights to seek care for their children. The 8-1 ruling maintains the law, effective since September 2023, making Texas the largest state to enforce such restrictions among at least 25 others. The law prohibits hormone therapies, puberty blockers, and transition surgeries for minors, with exceptions for certain medical conditions, drawing criticism for its perceived discriminatory nature. Opponents, including major medical organizations, argue the law harms transgender youths’ mental health and limits essential care, while supporters claim it protects children. The decision aligns with a broader national trend of legislative actions against transgender rights, with ongoing legal challenges and potential future federal implications.

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Health Law Highlights

Why Nurses Are Protesting AI

Summary of article from Healthcare Brew, by Tom McKay:

The National Nurses United (NNU) is protesting the increasing use of AI in healthcare, arguing it devalues nursing skills and exacerbates understaffing issues. They claim that AI-driven continuous data collection cannot replace the expertise and physical presence of nurses, often leading to inefficiencies and potentially harmful practices. Nurses report that AI systems sometimes prevent them from overriding critical decisions and can limit direct patient-doctor communication. Additionally, many AI tools are unregulated and untested, raising concerns about their reliability and the speed at which they are being implemented. While nurses acknowledge the benefits of certain technologies, they emphasize that poorly integrated AI can become a significant burden.

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Health Law Highlights

Blockchain-Based Healthcare Credentialing: A Solution to High Costs and Administrative Burdens

Summary of article from Cureus, by Ebenezer Chinedu-Eneh, Priya Ramaswamy, Patrick E. Farmer:

The healthcare sector faces significant inefficiencies in its credentialing system, leading to staff shortages, delayed patient care, and financial waste. The COVID-19 pandemic highlighted these issues, prompting temporary suspensions of credentialing processes. Blockchain technology offers a promising solution by automating and securing credential verification, potentially saving time and costs, increasing trustworthiness, and enhancing workforce resilience. Successful implementations in other countries demonstrate blockchain’s potential to revolutionize healthcare administration. Adopting blockchain for credentialing could transform the system, making it more efficient, reliable, and secure.

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Alert

Eight Charged Locally as Part of National Health Care Fraud Enforcement Action

Press Release from United States Department of Justice, Southern District of Texas:

On June 27, 2024, the U.S. Attorney’s Office for the Southern District of Texas announced charges against eight individuals as part of the Justice Department’s 2024 National Health Care Fraud Enforcement Action. These charges involve various schemes, including fraudulent Medicare billing, kickbacks, and money laundering, amounting to over $2.75 billion in false billings nationwide. The accused include residents from Texas and Florida, with allegations ranging from operating fake businesses to billing for unprovided medical services. The enforcement action resulted in the seizure of over $231 million in assets. The FBI, Health and Human Services OIG, and other federal and state agencies conducted the investigations, while Assistant U.S. Attorneys and Department of Justice Trial Attorneys are prosecuting the cases.

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Health Law Highlights

Federal District Court Finds Private-Insurer Relator Can Proceed with False Claims Action

Summary of article from The FCA Insider, by Michael Podberesky, Brett Barnett, Stephen Tagert:

The U.S. District Court for the District of New Jersey allowed Allstate Insurance Company to proceed with its whistleblower action against Phoenix Toxicology and Lab Services, LLC, alleging the submission of false claims for unnecessary urine drug tests to federal programs. This case highlights a trend of non-traditional whistleblowers, such as private insurers and litigation-funding groups, increasingly bringing False Claims Act actions. The ruling underscores the importance for healthcare providers to be vigilant about potential fraud detection by both insiders and external parties. This decision also illustrates the growing role of the Department of Justice in addressing fraudulent activities related to the opioid epidemic and federal healthcare programs.

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Health Law Highlights

Six Months to Go: HIPAA Privacy Rule Changes Require Additional Diligence

Summary of article from Taft Privacy & Data Security Insights, by Scot Ganow:

The Department of Health and Human Services (HHS) has issued final regulations modifying the HIPAA Privacy Rule to protect individuals’ reproductive health information, effective June 25, 2024, with compliance required by December 23, 2024. These changes prohibit HIPAA-regulated entities from disclosing protected health information (PHI) for purposes of investigating or imposing liability for lawful reproductive health care. Additionally, the regulations establish a presumption of lawfulness for reproductive care and mandate obtaining signed attestations for certain disclosures. HIPAA-covered entities and business associates must update their policies, procedures, agreements, and training to align with these new requirements. Notices of privacy practices must also be revised by February 16, 2026.

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Health Law Highlights

Healthcare Scores a B for Cybersecurity

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

SecurityScorecard awarded the U.S. healthcare industry a B+ cybersecurity rating for the first half of 2024, despite significant breaches, including a major ransomware attack on Change Healthcare. The study assessed the top 500 publicly traded healthcare companies, revealing a mean security score of 88. Medical device manufacturers and suppliers had the lowest security scores within the sector, largely due to their extensive attack surfaces. Key areas for improvement include application security, DNS health, and network security, with common issues such as weak SSL/TLS protocols and outdated web browsers. Recommendations for enhancing security emphasize third-party risk management and improved application and endpoint security practices.

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Health Law Highlights

Cyber Attacks on Health Care Up 136% Last Year

Summary of article from Medical Economics, by Grace Koennecke:

In 2023, the US experienced a significant rise in data breaches, with 3,205 incidents reported, marking a 78% increase from 2022. The healthcare industry saw a 136% increase in data breaches, affecting 56 million individuals, while the financial services sector experienced a 177% rise, impacting 61 million people. The Identify Theft Resource Center recommends the healthcare sector adopt stronger breach notice laws and improve vendor due diligence to mitigate cyber threats.

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Health Law Highlights

“Wheels Fall Off” FTC’s Latest Hospital Merger Challenge

Summary of article from Holland & Knight LLP, by Bill Katz, David Kully, Krithika Rajkumar:

The Judge in FTC v. Community Health Systems Inc. & Novant Health Inc., denied the FTC’s motion to block Novant Health’s $320 million acquisition of two hospitals, marking a rare loss for the FTC in hospital merger challenges. The ruling revitalized the “failing firm” defense, suggesting that the assets in question would cease to be competitive without the merger, despite not meeting the stringent criteria outlined in the Merger Guidelines. The court acknowledged potential harm to competition but emphasized that the acquisition would likely enhance investment and competition in the Charlotte area. The FTC has appealed the decision, with the application of the failing firm defense expected to be a key issue. This case may influence future hospital mergers involving financially distressed entities.