K&L Gates Healthcare Triage

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 paymen...

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 f...

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.

In part one of this two-part series, Matt Miller and Andrew Lloyd analyze representations and warranties insurance (RWI) in the healthcare M&A landscape. They discuss the benefits of RWI for buyers and sellers, policy structures, premiums, and strategies to ensure effective coverage. The conversation also highlights RWI's role in healthcare transactions, insights on carriers providing coverage, an...

In this special Veterans Day episode of Triage, Matt Miller is joined by The Davis Focus Project's  Brandon Davis , a former Black Hawk instructor pilot. Brandon shares his experience in the military and how it led him to start  The Davis Focus Project , an organization dedicated to supporting veterans to overcome traumatic brain injuries, PTSD, and other physical and psychological wounds they hav...

In this two-part Triage series, Gina Bertolini, Stephen Page, and Sarah Staples-Carlton discuss an old healthcare regulatory doctrine that has new relevance in a post-COVID world, where the delivery of care via telemedicine and other remote models has become heavily adopted: Corporate Practice of Medicine, or "CPOM." As more and more health care companies look for innovative ways to deliver health...

In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving our nation's health care providers have precipitously risen in the past five years. The Department of Health and Human Services' Office for Civil Rights (OCR) reports a nearl...

In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving our nation's health care providers have precipitously risen in the past five years. The Department of Health and Human Services' Office for Civil Rights (OCR) reports a nearl...

In this episode, Rebecca Schaefer, Michael Hinckle, and Elisabeth Lewis summarize FDA regulatory developments from 2023 and what to expect in 2024 as it relates to clinical research. They discuss the significance of the decentralized clinical trials guidance documents, highlights of the Informed Consent Guidance document, the impacts of FDA's final rule on IRB waivers of consent, the IRB review of...

In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA's latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation requirements for informed consent, and the impacts of the guidance for IRBs, clinical investigators, and sponsors.

In this episode, Rebecca Schaefer and Martin Folliard discuss cybersecurity threats faced by health care organizations and a new federal research agency initiative to help create security tools to protect the US health care system from cyberattacks.

In this episode, Darlene Davis, Leah Richardson, and Andrew Ruskin unravel CMS's proposed rule for the remedy for Medicare payments for drugs purchased under the 340B Program and reimbursed as hospital outpatient services. The discussion includes background of the unlawful 340B drug reimbursement policy, as well as CMS's proposed remedy. They also discuss the way in which CMS suggests that it will...

In this episode, Alexander Chu and Ashley Davis review the end of the continuous Medicaid enrollment condition as a result of the Consolidated Appropriations Act, 2023. They discuss potential impacts of the disenrollment process for health care providers and provide helpful tips for health systems to navigate this change.

In this episode, Macy Flinchum talks with Limo Cherian and Steven Pine about some of the major takeaways, challenges, and successes that providers have experienced in navigating the new regulatory flexibilities for value-based arrangements announced in 2020.

In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA's recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical trials, as well as notable planning considerations and regulatory requirements for both the industry sponsors and the academic medical centers, research institutions and other provi...

 In this episode, Sarah Carlins and Spencer Hamer discuss employment law and the health care sector. They review highlights from 2022, as well as developments that will impact employment law and the health care sector in 2023, including vaccine mandates, telehealth regulations, pay equity, and health care staffing regulations.

In this episode of Triage, Andrew Ruskin, Darlene Davis, and Gabriel Scott discuss key provisions associated with conversion to CMS's new rural emergency hospital provider type. They review the purpose of the new provider type, considerations and requirements for converting, as well as the benefits and drawbacks of a transition to a rural emergency hospital. 

In this episode, Norman Acker, Nora Becerra, and Katherine Rippey discuss the False Claims Act as it relates to Stark Law and the Anti-Kickback Statute. They analyze the Wheeling Hospital case and the Catholic Medical Center case and discuss key takeaways from the cases as they relate to the False Claims Act.  

In this episode Victoria Hamscho, Andrew Ruskin, and Leah Richardson provide an update on key developments to the 340B Program. They discuss the effects of the Supreme Court's decision earlier this year overturning 340B hospital reimbursement cuts, the agency's proposed rule with respect to hospital outpatient reimbursement, and some considerations for hospitals when reviewing Medicare Advantage c...

In this episode, Gina Bertolini and Stephen Page discuss the most recent Information Blocking Rule compliance deadline. Using a recent letter from several health care providers and other stakeholders to the Office of the National Coordinator for Health IT (ONC) that outlines concerns related to the Information Blocking regulations, Gina and Stephen discuss the definition of electronic health infor...