K&L Gates Healthcare Triage

In this episode, Nora Becerra is joined by partner Kevin Alonso and associate Morgan Lee to explore ACCESS, a new accountable care model developed by the Centers for Medicare and Medicaid Services. They offer a practical overview of the model and discuss considerations for healthcare providers and organizations evaluating whether it may be the right fit.

In this episode, Gabe Scott, Natalia Nino, and Darrell White discuss the Drug Supply Chain Security Act following the FDA's warning letter to a medical spa over Botox products. Their conversation explores what the enforcement action reveals about the agency's compliance expectations, what it may signal about the FDA's priorities, and the steps dispensers should be taking now to mitigate risk and stay compliant.

In this episode, Gabe Scott, Kevin Alonso, and Cindy Laura Ortega Ramos unpack recent updates to the federal independent dispute resolution (IDR) process under the No Surprises Act. They discuss the operational changes introduced in May by the Departments of Health and Human Services, Labor, and the Treasury, along with the Office of Personnel Management, and what these updates mean for how payment disputes are processed and resolved.

In this episode, Gabe Scott, Sarah Carlins, and Myia Pretty discuss two significant proposed HIPAA rulemakings, including updates to the HIPAA Security Rule and proposed modifications to the HIPAA Privacy Rule. They outline the key policy changes and their underlying rationale, as well as what stakeholders should watch for as these processes move forward.

In this episode, Limo Cherian and Nora Becerra focus on key issues faced by in-house counsel and compliance teams as they address attorney-client privilege concerns. Their discussion focuses on the complexities of privilege that arise during healthcare investigations, specifically those involving fraud and abuse.

In this episode, Limo Cherian, Andy Ruskin, and Sarah Staples-Carlton unpack the Consolidated Appropriations Act of 2026 and its impact on provider-based clinics. They explain what provider-based status means, why mandatory attestations are back, and what hospitals and health systems must do to stay compliant and protect Medicare reimbursement.

In this episode, Gabriel Scott, Kevin Alonso, and Kennedy Caldwell break down the new Long Term Enhanced ACO Design (LEAD) Model and its impact on accountable care. They provide background on the model, outline key new features, and discuss five issues that Accountable Care Organizations and providers should consider as they evaluate participation.

In this episode, Gabriel Scott, Mark Ogunsusi, and Amanda Smith take a focused look at the 340B Drug Pricing Program, with particular attention to recent developments related to proposals for a 340B rebate model. They discuss why stakeholders may support or oppose a rebate‑based approach to 340B pricing and highlight key considerations relating to such a model.

In this episode, Limo Cherian, Rebecca Schaefer, and Clarita Sullivan break down the Department of Health and Human Services' (HHS) recent Request for Information on Accelerating the Adoption and Use of Artificial Intelligence (AI) as part of Clinical Care. They discuss why HHS is seeking input from both AI innovators and those facing adoption barriers, what the agency hopes to achieve with this feedback, and how it could shape future regulations, reimbursement policies, and research priorities. If you are an in-house attorney navigating the evolving AI landscape, tune in for practical insights on regulatory trends, federal priorities, and what's next for AI in healthcare. As mentioned in the episode, you can view HHS's consolidated responses and copies of schedules here.

In part two of this two-part series, Matt Miller and Andrew Lloyd analyze representations and warranties insurance (RWI) in the health care M&A landscape.

They discuss the process of finding and securing an insurance underwriter, practical tips for structuring and negotiating RWI policies, how to navigate a claim after the policy is in place, and future trends in the RWI market.