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RWI in Healthcare M&A: Part 2
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…
RWI in Healthcare M&A: Part 1
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…
Veterans Day Special Episode: Combating Traumatic Brain Injury
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…
Corporate Practice of Medicine: New Relevance in a Changing World
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…
Health System Cybersecurity Risks: Part Two
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.…
Health System Cybersecurity Risks: Part One
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.…
Highlights from FDA Regulatory Developments in Clinical Trials: 2023 Recap and 2024 Forecast
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…
FDA Issues Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors
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…
Ensuring Continuity of Care Following a Cyberattack: ARPA-H Launches Project to Enhance Cybersecurity Tools for Health Care Organizations
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…
Unpacking CMS's Proposed Rule for Correcting Underpayments for 340B Drug Reimbursement
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…
The End of Continuous Medicaid Enrollment—What Health Systems Should Know
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…
Value-Based Lessons Learned: Two Years Later, How Have Providers Utilized New AKS and Stark Flexibilities?
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…
Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical Trials
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…
2022 Health Care Employment Law Year in Review
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…
Rural Emergency Hospitals — Transformative Change or Limited Impact?
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…
Stark Law and the Anti-Kickback Statute Under the False Claims Act
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…
Recent Developments to the 340B Drug Pricing Program
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…
The Information Blocking Rule's "Glide Path" - Compliance with the Information Blocking Rule After the Limitation on the Scope of EHI is Lifted
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…
New Data Available Under the Hospital Price Transparency Rule
In this episode, Darlene Davis, Andrew Ruskin, and Lauren Norris Donahue review data that is now available in light of the hospital price transparency rule. They discuss the recent increase in…
Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight
In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA's jurisdiction over…
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K&L Gates Healthcare Triage has published 99 episodes since September 2019, covering topics in Business, Government.
K&L Gates Healthcare Triage is currently dormant with new episodes monthly. Average episode length is 15m.
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