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Health Law Highlights

Medicaid: CMS Final Rules Aim to Expand Access, Provide Parity with Commercial Markets

Summary of article from Foley & Lardner LLP, by Anil Shankar:

The Centers for Medicare & Medicaid Services (CMS) introduced two significant updates to its Medicaid regulations on May 10, 2024: the Medicaid Access Rule and the Medicaid Managed Care Rule. These updates aim to enhance and standardize reporting, monitoring, and evaluation of Medicaid services, potentially increasing Medicaid reimbursement. The new rules require states and Medicaid managed care plans to report and analyze payment rates and access to services, and to implement corrective action plans for identified access deficiencies. The Managed Care Rule introduces federal “appointment wait time” standards and allows states to increase Medicaid reimbursement to match commercial plan rates. Lastly, the Access Rule establishes a numerical floor for Medicaid rates and requires at least 80% of Medicaid payments to home and community-based service providers to be spent on direct care workers’ compensation.

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Health Law Highlights

FTC Cleared To Sue Texas Anesthesia Co., But Not PE Firm

Summary of article from Law360, by Bryan Koenig:

A Texas federal judge has ruled that the Federal Trade Commission (FTC) lacks the authority to pursue antitrust claims against private equity firm Welsh Carson Anderson & Stowe, but can proceed against the anesthesia group the firm created, U.S. Anesthesia Partners Inc (USAP). The judge ruled that the FTC could not prove an ongoing or likely future antitrust violation by Welsh Carson, which had sold off its controlling stake in USAP in 2017. This decision could impact the FTC’s efforts to challenge private equity strategies of acquiring entire sectors through individual transactions. The ruling also underscores the FTC’s ongoing struggle to expand its authority under Section 13(b) of the FTC Act. Despite this, the judge found sufficient evidence of ongoing violations by USAP, allowing the FTC’s case against it to proceed.

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Health Law Highlights

Envisioning the Future of Health Care With OpenAI’s GPT-4o

Summary of article from KevinMD, by Harvey Castro, MD, MBA:

OpenAI’s GPT-4o promises to revolutionize health care with advanced predictive analytics, enhanced surgical assistance, personalized medicine, automated health monitoring, and virtual health assistants. It aims to improve emergency responses, offer immersive education and training, facilitate cross-border medical collaboration, enhance mental health services, streamline administrative processes, and foster community health initiatives. The system is built to eliminate dataset bias and ensure data security with HIPAA-compliant servers. GPT-4o’s potential applications range from predicting health trends to automating administrative tasks, all while ensuring patient data remains private and secure. This transformative AI technology is poised to improve patient outcomes, enhance operational efficiency, and foster a more equitable and advanced health care system.

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Health Law Highlights

HIPAA Privacy Final Rule: Landmark Changes Related to Reproductive Health Care Information

Summary of article from Polsinelli, by Hiba AI-Ramahi, Iliana Peters, Rebecca Frigy Romine:

The U.S. Department of Health and Human Services (HHS) and Office for Civil Rights (OCR) issued a “Final Rule” providing special protections and obligations related to Protected Health Information (PHI) about reproductive health care. The Rule applies to all HIPAA regulated entities and covers a broad range of reproductive health care services. It prohibits the use or disclosure of PHI for the purpose of conducting a criminal, civil, or administrative investigation into or imposing liability on any person for seeking, obtaining, providing, or facilitating reproductive health care. Regulated entities must obtain a signed, written attestation from the person or entity requesting the PHI that the intended use or disclosure of the requested PHI is not for one of the prohibited purposes. This Rule is effective on June 25, 2024, with regulated entities given 180 days for compliance and until February 16, 2026 for Notice of Privacy Practices (NPP) modification compliance.

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Health Law Highlights

Better Call Your Privacy Attorney: 3 New State Privacy Laws Begin July 1, 2024

Summary of article from Dickenson Wright, by Sara Jodka:

On July 1, 2024, Florida, Oregon, and Texas will join other states in implementing privacy laws to govern the collection, use, and transfer of consumer personal data, with Montana following on October 1, 2024. These laws will impose requirements on businesses collecting personal data, and although existing privacy programs may not need significant changes, new businesses will need to update their privacy policies and processes. The laws vary between states, with Texas having the broadest application and Florida the narrowest, and they encompass different definitions of personal data and sensitive data. Covered entities will need to provide clear privacy notices, limit data collection, obtain consumer consent for processing sensitive data, implement safeguards, and conduct data protection assessments among other requirements. Beyond 2024, more states including Delaware, Iowa, Nebraska, New Hampshire, New Jersey, and Tennessee will implement similar laws in 2025, with Indiana and Kentucky following in 2026.

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Health Law Highlights

The Future of Technology in Health Care

Summary of article from The Regulatory Review, by Alyson Diaz, Julia Englebert, and Carson Turner:

The use of technology in healthcare, particularly AI and telemedicine, is increasing, but many Americans are uncomfortable with AI’s role in diagnosis and treatment due to potential biases and errors. While AI can improve care quality and accessibility, especially for underserved communities, it also presents risks such as algorithmic bias and overreliance. Current regulations, including the FDA’s 510(k) review, inadequately address these concerns and often allow AI-enabled devices to be approved without sufficient safety and accuracy checks. Scholars suggest various regulatory improvements, including educating patients about algorithmic bias, continuous assessment of AI technologies, and lowering barriers for community organizations to provide telehealth services. Concerns also extend to the influence of direct-to-consumer pharmaceutical companies on social media, and the need for stricter regulation of telehealth providers to prevent inadequate treatment and excessive drug prescriptions.

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Health Law Highlights

FTC Finalizes Expansion of Health Breach Notification Rule’s Broad Applicability to Unauthorized App Disclosures

Summary of article from Davis Wright Tremaine, by Adam H. Greene, Apurva Dharia:

The Federal Trade Commission (FTC) has finalized changes to the Health Breach Notification Rule (HBNR), expanding its scope to include virtually all health and wellness apps. The revised rule requires vendors of personal health records (PHRs) and related entities to notify individuals, the FTC, and, in some cases, the media of any unauthorized disclosure of identifiable health data. The updated rule also includes a broader definition of “health care services or supplies” and “breach of security,” and clarifies the role and responsibilities of PHR related entities. The FTC has also modernized the method of notice, expanded the content of the notice, and revised the timing of notice to the FTC. The changes signal the FTC’s increased prioritization of protecting consumers’ sensitive health information.

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Health Law Highlights

Importance of Negotiating Maintenance, Repair and Replacement Obligations in Health Care Leases

Summary of article from Epstein Becker Green, by Allison S. Zangrilli, Zlata Fayer:

Tenants are often held responsible for the repair and maintenance of mechanical systems in leased premises, which can lead to significant costs. To mitigate this, tenants should inspect these systems before signing the lease and negotiate a warranty period with the landlord for any necessary repairs or replacements. Additionally, tenants should negotiate for the installation of any additional systems they require during the letter of intent phase. A carve-out for latent defects should be included in the lease, and tenants should negotiate to ensure costs for maintaining structural components are not passed onto them. Detailed negotiation of maintenance, repair, and replacement obligations is crucial to protect tenants and should be outlined in a letter of intent to clarify expectations and streamline the negotiation process.

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Health Law Highlights

The Intersection of Artificial Intelligence and Utilization Review

Summary of article from Sheppard Mullin Richter & Hampton LLP, by Lynsey Mitchel:

California’s SB 1120 bill aims to regulate the use of artificial intelligence (AI) in managed care, requiring AI tools to be fair, non-discriminatory, and based on a patient’s medical history and individual circumstances. The bill aligns with the Centers for Medicare and Medicaid Services (CMS) rules, which allow the use of AI in coverage determinations as long as the AI complies with all applicable rules and does not solely dictate decisions. Other states like Georgia, New York, Oklahoma, and Pennsylvania have similar bills, focusing on regulator review and disclosure of AI use. Various states have also adopted the National Association of Insurance Commissioners’ guidelines to mitigate the risk of adverse outcomes from AI use. Payors are urged to monitor their AI tools closely to reduce the risk of legal issues arising from improper service denials.

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Health Law Highlights

Cloud-Based AI Services Could Help Fight Health Misinformation

Summary of article from Healthcare IT News, by Andrea Fox:

Several major universities are developing a platform named Project Heal to combat healthcare and public health misinformation. The platform will use machine learning, generative AI, and predictive analytics to identify and counteract misinformation before it spreads. The system also accounts for cultural, historical, and linguistic nuances to generate personalized messages for targeted communities.