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Health Law Highlights

HHS Issues New Affordable Care Act Section 1557 Nondiscrimination Regulations

Summary of article from Seyfarth Shaw LLP, by Kristina Launey, Leon Rodriguez:

Section 1557 of the Affordable Care Act prohibits discrimination in health programs receiving federal financial assistance. It has been subject to changes across different Presidential administrations since its inception in 2016. The latest regulations, effective from August 6, 2024, restore some repealed provisions and enhance nondiscrimination requirements. The Final Rule restores protections against discrimination based on sexual orientation, gender identity, disability, and religious objections, and expands its reach to include Medicare Part B providers, private insurance plans, and AI patient decision-making tools. It also mandates language assistance and accessibility services, and re-states federal protections for religious freedom and conscience.

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Health Law Highlights

OCR HIPAA Audit Program to Commence in 2024

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

The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 mandates periodic audits of HIPAA-regulated entities by the Office for Civil Rights (OCR) to assess HIPAA compliance, with a focus on the HIPAA Security Rule. OCR has confirmed that audits will be conducted in 2024. The increasing rate and scale of data breaches suggest inadequate compliance with the HIPAA Security Rule among healthcare organizations. OCR aims to improve future audit programs and cybersecurity across the healthcare sector, with a particular focus on risk analysis and management provisions of the HIPAA Security Rule. OCR is working on an update to the HIPAA Security Rule, expected to be finalized by the end of the year, to reflect changes in technology and working practices, including the adoption of cloud technology, encryption, and multifactor authentication.

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Health Law Highlights

Health Care, AI and Antitrust: Analysis and Next Steps

Summary of article from Manatt, Phelps & Phillips, LLP, by Dylan Carson, Harvey Rochman:

As artificial intelligence (AI) becomes more prevalent in the health care industry, there are growing concerns about potential anticompetitive conduct, including algorithmic price fixing. This issue was highlighted in a recent New York Times report alleging that certain health plans and administrators were using the same company’s algorithmic tools to set out-of-network rates, potentially leading to higher costs for patients. Antitrust enforcers argue that using the same AI systems to set prices could be seen as collusion and therefore a violation of antitrust laws. Health care companies are advised to closely monitor these developments and consider the potential legal risks associated with their use of AI.

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Health Law Highlights

DOJ Introduces Task Force on Health Care Monopolies and Collusion

Summary of article from King & Spalding, by Catherine Behnke:

The Department of Justice (DOJ) recently announced the establishment of a Health Care Monopolies and Collusion (HCMC) Task Force. This initiative is part of the Biden administration’s broader effort to enhance antitrust enforcement in the health care sector, including measures aimed at increasing transparency, promoting competition, and curbing corporate greed. The HCMC Task Force will identify and address monopolistic and collusive practices that contribute to rising health care costs and decreased quality of care. The Task Force will focus on issues such as payer-provider consolidation, serial acquisitions, labor and quality of care, medical billing, health care IT services, and misuse of health care data. The HCMC Task Force will include a multi-disciplinary team of civil and criminal prosecutors, economists, health care industry experts, technologists, data scientists, investigators, and policy advisors.

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Health Law Highlights

Cracking the Whip: The FTC’s Clampdown on Healthcare Marketing

Summary of article from Nelson Hardiman, LLP, by Harry Nelson:

The U.S. healthcare system, driven by a complex mix of economic considerations, permits direct-to-consumer pharmaceutical advertising, unlike many other Western nations. However, this practice can lead to misleading claims and deceptive marketing, especially affecting vulnerable individuals. Recently, the Federal Trade Commission (FTC) has increased scrutiny on such practices, as evidenced by lawsuits against companies like AWAREmed and Rejuvika for misleading advertising. In 2024, the FTC also penalized telehealth providers, Cerebral and Monument, for violating confidentiality and misusing personal data. The FTC’s actions signal a shift towards protecting consumers from deceptive healthcare marketing practices.

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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.