Healthcare Law Blog

Shaping the World of Healthcare Law

As legal and policy developments continue to evolve, hospitals and health care professionals that provide gender-affirming care face new uncertainties regarding federal funding, compliance, and patient access. While these changes may not impact health care organizations that do not offer gender-affirming services, those that do must stay informed to navigate the rapidly changing legal landscape.
Continue Reading Updated: The Future of Gender-Affirming Care – New Legal and Regulatory Considerations for Hospitals Providing These Services

The recent U.S. election has had profound implications for the healthcare industry, prompting industry leaders to reexamine their strategies and day-to-day operations. At the Miami Herbert Business School’s annual “The Business of Health Care” conference on January 24, 2025, a pivotal forum brought together stakeholders across key sectors—home care, hospital systems, payors, and others—to assess the election’s impact and chart a path forward. The conference highlighted the need for collaboration, innovative solutions, and strategic leadership in addressing the challenges ahead.
Continue Reading Healthcare Industry Leaders Predict Four Areas to Watch After the U.S. Election: Takeaways from the Business of Health Care Conference Hosted by the Miami Herbert Business School

The Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) recently issued the final “HHS Notice of Benefit and Payment Parameters for 2026” (hereinafter referred to as the “Rule”) setting new and updated standards for Health Insurance Marketplaces and health insurance issuers, brokers, and agents who help connect millions of consumers to health insurance coverage. Effective January 15, 2025,[1] the Rule finalizes additional safeguards for marketplace coverage beginning plan year 2026, protecting consumers from unauthorized changes to their health care coverage, ensuring the integrity of the federally facilitated Marketplaces, and making it
Continue Reading May the Coverage Be With You: Navigating CMS’s Changes to the Health Insurance Marketplace

Hospitals charge a standard evaluation and management services fee (“EMS”) for patients seen in the emergency room, in one of five amounts, depending upon the severity of the visit. This EMS fee is listed in the hospital’s public “chargemaster,” a comprehensive price list required by law. But does the hospital also have a duty to inform individual ER patients, before they receive services, about the EMS fee?
Continue Reading California Supreme Court Rejects Non-Disclosure Theory for ER Evaluation and Management Fees, Holding that Hospitals owe no Additional Duty Outside Regulatory Pricing Disclosure Regime

The proposed New York Health Information Privacy Act (NYHIPA), currently awaiting Governor Kathy Hochul’s signature, represents a major step in the state’s approach to protecting personal health data in the digital age. At its core, the bill aims to establish stronger privacy protections and restrict the use and sale of health-related data without explicit user consent. Supporters see it as a necessary evolution of data privacy laws, addressing gaps in federal regulations like HIPAA and responding to growing consumer concerns.
Continue Reading New York’s Health Information Privacy Act: A Turning Point for Digital Health or a Roadblock to Innovation?

In January 2025, New York Governor Kathy Hochul proposed legislation within her FY 2026 Executive Budget that could significantly reshape healthcare transactions in the state. This legislation introduces a “Cost Market Impact Review” (CMIR) process for material transactions involving healthcare entities, aiming to assess their effects on cost, quality, access, health equity, and competition. While the proposal has sparked conversations across the healthcare and private equity sectors, it offers a pivotal opportunity for strategic planning and collaboration if approached with foresight.
Continue Reading Navigating New York’s Proposed Cost Market Impact Review

On January 8, 2025, Massachusetts Governor Maura Healey signed House Bill 5159 (“H.5159”) into law, marking a notable expansion of the regulation of private equity investments within the Massachusetts healthcare sector. The legislation, set to take effect on April 8, 2025, introduces new measures to enhance transparency and accountability in healthcare transactions, focusing specifically on private equity firms, real estate investment trusts (“REITs”), and management services organizations (“MSOs”). This development also reflects a broader trend across the nation of increasing scrutiny of healthcare transactions and investments by private equity firms and other investors, as highlighted in our previous blog series
Continue Reading Massachusetts Expands Oversight of Private Equity Investment in Healthcare: Key Takeaways from House Bill 5159 Signed into Law by Governor Healey

President Trump was sworn into office on Monday, promising swift action on several fronts. There is already a new Federal Trade Commission (“FTC”) Chair, Andrew Ferguson, with former FTC Chair Lina Khan expected to step down shortly. At the Department of Justice, Antitrust Division (“DOJ”), proposed AAG Gail Slater will need to be confirmed by the Senate before she can take the helm.
Continue Reading Looking Back and Looking Forward: Healthcare Antitrust in a New Administration: What Stays the Same and What Changes?

I’m honored to participate in the University of Miami’s Business of Health Care Conference on January 24, 2025. This highly anticipated event brings together leaders from the nation’s most influential health care organizations to discuss the evolving health care landscape under the incoming administration.
Continue Reading Health Care at a Crossroads: Insights from the Post-Election Health Care Conference

Navigating the Certificate of Need (CON) process in New York is no small task. It’s a critical gateway for healthcare providers, particularly in the long-term care sector, to establish, expand, or modify services. The laws and regulations governing this process—rooted in Articles 28, 36, and 40 of New York’s Public Health Law—are complex, ever-evolving, and often overwhelming for even the most seasoned professionals.
Continue Reading Inside the World of Long-Term Care Certificate of Need (CON): An Exclusive Opportunity

New York State has a long-standing commitment to supporting its most vulnerable populations through Medicaid-funded services for older adults and those requiring long-term care. However, rising costs and an increasingly complex healthcare landscape have created challenges that demand innovative solutions. As New York seeks to align its healthcare system with evolving needs, the time has come to adopt integrated care models that promote sustainability, efficiency, and improved outcomes.
Continue Reading Building a Smarter Long-Term Care System in New York

The U.S. Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking (the “Proposed Rule”) on December 27, 2024, to significantly amend HIPAA’s Security Rule, which sets forth the security standards for the protection of protected health information by covered entities and their business associates. The Proposed Rule’s issuance was expected, especially in light of the growing number of health data breaches and disclosures of large scale foreign cyberattacks.
Continue Reading HHS’ Last-Minute Holiday Gift: Proposed Changes to the HIPAA Security Rule

Cyberattacks on healthcare organizations are on the rise, with the number of affected individuals nearly tripling between 2022 and 2024, according to data compiled by the Department of Health and Human Services Office for Civil Rights (“OCR”).[1] OCR data also reveals a 239% and 278% increase in hacking incidents and ransomware attacks, respectively, between January 2018 and September 2023.
Continue Reading New York Adopts Comprehensive Hospital Cybersecurity Requirements

As the shift toward value-based care continues to transform the healthcare industry, hospitals and health systems are increasingly utilizing incentive-based physician compensation structures. Incentive-based compensation often includes a combination of a base salary with a variable bonus component tied to performance metrics, with the metrics being chosen based on overarching organizational goals, such as improving quality of care and managing costs. With these aims in mind, hospitals and health systems often base bonus achievement on meeting certain objective metrics, such as patient satisfaction scores, productivity measures, adherence to clinical guidelines, cost-saving measures, or other quality indicators most applicable to the
Continue Reading Navigating Gainsharing Pitfalls in Value-Based Models