Category: Health Law Highlights

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Health Law Highlights

Will Regulatory Scrutiny Impact Private Equity Investment in Healthcare?

Summary of article from Ankura, by Anthony Metke, Robert Mundy:

Private equity (PE) investment in healthcare has grown substantially in the past decade due to the sector’s fragmentation, potential for scale, and attractive returns. However, this trend has raised concerns about the implications for patient care, costs, and industry structure. The Federal Trade Commission (FTC) and other regulatory bodies have recently increased their scrutiny of PE in healthcare, highlighting the potential risks of prioritizing profit over patient care. The future of PE investment in healthcare will likely involve a more cautious approach, with increased emphasis on regulatory compliance, transparency, and alignment with broader healthcare improvement goals. PE firms may need to adapt their investment strategies to a more long-term perspective, aligning with the goals of improving healthcare delivery and patient outcomes.

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Health Law Highlights

Healthcare Cybersecurity: Preventing Data Breaches

Summary of article from Security Boulevard, by Rom Carmel:

The healthcare sector is facing an escalating threat from cyberattacks, with an unprecedented 725 large data breaches reported in 2023. The primary causes are system vulnerabilities, human errors, and a surge in sophisticated cyberattacks. The consequences of these breaches are manifold, including major financial burdens, significant reputational damage, and infringing patient privacy. To mitigate these risks, it’s essential to implement a robust cybersecurity infrastructure, perform regular audits and risk assessments, and provide comprehensive cybersecurity training to employees. Apono, a specialized platform, can support healthcare firms with these preventative measures, contributing to safeguarding patient data, maintaining service integrity, trustworthiness and compliance with industry standards.

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Health Law Highlights

Understanding Barriers to Cyber Resilience in Healthcare

Summary of article from HealthIT Security, by Jill McKeon:

Cyber resilience in healthcare, which enables swift response and recovery from cybersecurity incidents, faces several barriers including a lack of understanding of the concept, misalignment between cybersecurity and business, and the complexity of IT systems. Research by LevelBlue reveals that 76% of healthcare organizations view cyber resilience as primarily the responsibility of cybersecurity teams, rather than an enterprise-wide priority. Budgets are often reactive, with 77% of respondents describing their budgets as such, and there is a notable lack of understanding about cybersecurity at the board level. The rapid innovation in healthcare technology, while beneficial, adds to the cyber risk, making resilience more complex. To improve cyber resilience, healthcare organizations should use reporting metrics and analysis, increase communication at the C-suite level, improve employee training, and adopt resources like the Health Industry Cybersecurity Practices (HICP) for better alignment with the National Institute of Standards and Technology (NIST) Cybersecurity Framework (CSF).

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Health Law Highlights

Streamlining Hospital Operations, Optimizing Resource Allocation, and Improving Efficiency with AI Predictive Analytics and Machine Learning Algorithms

Summary of article from Healthcare IT Today, by Grayson Miller:

AI-driven predictive analytics and machine learning algorithms are revolutionizing healthcare by streamlining hospital operations, optimizing resource allocation, and enhancing system efficiency. They help predict patient admission rates, manage bed occupancy, forecast staffing needs, and predict the demand for medical supplies with remarkable accuracy. AI technologies also facilitate quicker and more accurate disease diagnoses by analyzing vast datasets, and help in early intervention and preventive measures for patients at risk. The integration of AI in healthcare is anticipated to grow, potentially reshaping healthcare delivery in ways yet to be fully realized. However, successful operational transformation requires more than just AI, with factors like data hygiene, workflow automation, and change management services being equally important.

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Health Law Highlights

Texas Company Connected to Alleged Scheme That Billed Medicare $3 Billion for Urinary Catheters

Summary of article from CBS Texas, by Brian New:

A Texas-based company, Konaniah Medical Supplies, is implicated in a suspected Medicare fraud scheme involving billing for urinary catheters that beneficiaries never ordered or received. The company, along with its associated entity G&I Ortho Supply in New York and eight other medical supply companies, collectively billed Medicare over $3 billion for catheters, causing a nearly 2,000% increase in Medicare billings for this product. The Centers for Medicare & Medicaid Services (CMS) have identified a concerning increase in urinary catheter billings and suspended payments to the implicated suppliers, but it remains unclear how much of the alleged fraudulent billings were paid out. U.S. Senator Mike Braun has called for a full federal audit of Medicare, and proposed a bill to use artificial intelligence for detecting potential billing irregularities. The investigation into the alleged fraud is ongoing.

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Health Law Highlights

How This Southlake Physician Ended Up Serving Federal Time

Summary of article from D Magazine, by Will Maddox:

Dr. Rodney Sosa, a Southlake physician, was convicted of defrauding the United States government and sentenced to 46 months in federal custody. The conviction was related to a telemedicine scheme involving unnecessary medical equipment and testing, for which he submitted $1.4 million worth of claims. His medical license was revoked in April 2024, following his sentencing in March. Sosa also allegedly practiced as a plastic surgeon at Ver Halen Aesthetics, despite his certification being in internal medicine. Investigations into Sosa’s activities at Ver Halen Aesthetics are ongoing.

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Health Law Highlights

What’s it to You? Justice Scalia’s 41-Year-Old Gatekeeping Question on “Standing” Influences Court to Uphold FDA’s Regulation of Mifepristone

Summary of article from Akerman LLP, by Noam Fischman, Danielle Gordet:

On June 13, 2024, the Supreme Court unanimously ruled that doctors and medical associations did not have standing to challenge the FDA’s approvals of mifepristone, a drug used for terminating pregnancies. The court found that the plaintiffs’ objections to abortion and the FDA’s regulation of mifepristone did not suffice to establish Article III standing for the lawsuit. The decision overturns a previous ruling by the U.S. District Court for the Northern District of Texas, which held that the plaintiffs had standing and were likely to win. The Court rejected several arguments from the plaintiffs, including claims of potential moral objections and economic injuries. The ruling suggests that some legal issues may not have a judicial resolution, and instead should be addressed by the legislative branch.

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Health Law Highlights

Texas Supreme Court Declines Opportunity to Hear Personhood Case

Summary of article from Epstein Becker Green, by Erin Sutton:

The Texas Supreme Court has declined to review the case Antoun v. Antoun, which sought to establish whether frozen embryos are considered persons or property under Texas law. The case arose after a divorce trial awarded the couple’s frozen embryos to the husband, based on their in vitro fertilization (IVF) consent form. The wife argued that under Texas’s total abortion ban, the embryos should be treated as human beings, not property, which would necessitate a different standard for determining “custody”. Despite this, the Court denied the review without comment. The decision may influence future legislation and court decisions regarding the personhood status of embryos, particularly in states with policies recognizing embryos as “unborn children”.

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Health Law Highlights

Fort Worth Physicians Assistant Sentenced in Medicare Fraud Case

Summary of article from WFAA, by Ben Sawyers:

North Texas physician’s assistant, Ray Anthony Shoulders, was sentenced to seven years in federal prison on counts of healthcare fraud, after submitting $788,000 in fraudulent medical claims and receiving over $614,000 in Medicare reimbursements. Shoulders was found to be injecting patients with amniotic fluid, a non-FDA approved treatment, under the guise of pain management. He manipulated billing codes to claim reimbursements from Medicare, using codes for an approved product while actually using a non-approved one. The scam, which operated intermittently between August 2020 and October 2021, resulted in significant profits for the clinic. Shoulders was ordered to pay $614,235 in restitution.

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Health Law Highlights

Justice Department Unseals Documents in Texas Children’s HIPAA Violation Case

Summary of article from Becker’s Hospital Review, by Naomi Diaz:

The U.S. Justice Department unsealed documents concerning Dr. Eithan Haim, who is accused of violating the Health Insurance Portability and Accountability Act (HIPAA) by illegally accessing and leaking internal documents from Texas Children’s Hospital. The documents pertained to gender-affirming services and included patients’ personal health information. Dr. Haim allegedly obtained this information with the intent to cause harm to the hospital. He shared these documents with a senior fellow at the Manhattan Institute, in May 2023. If convicted, Dr. Haim could face a maximum of 10 years in federal prison and a fine of up to $250,000.