K&l Gates Health Care Triage

In this two-part Triage series, Gina Bertolini, Stephen Page, and Sarah Staples-Carlton discuss an old health care 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 healthcare, it can be easy for seasoned healthcare professionals and newcomers alike to discount or dismiss CPOM. While on its face it is a straightforward prohibition, it is important to understand the doctrine’s underlying philosophy and to appreciate its complexity, particularly how it varies from state to state. This is particularly the case where telehealth has become an established method for the delivery of care, and many new companies are entering the health care space. As health care entities, health IT solutions providers, and other companies seek to deliver care in one or more states, there are many health care

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 nearly 300% increase in large data breaches that involve ransomware reported to OCR from 2018 to 2022. Interoperability remains a major government priority, and as remote care models continue to proliferate and the need intensifies for big data to feed increasingly complex technologies, risks to health care providers will continue to abound.   In part two, Gina Bertolini and Sarah Carlins discuss HHS’s “Healthcare Sector Cybersecurity” report, which outlines HHS’s strategy for securing the digital infrastructure of our nation’s health care system. HHS’s strategy includes increased funding for support and enforcement of

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 nearly 300% increase in large data breaches that involve ransomware reported to OCR from 2018 to 2022. Interoperability remains a major government priority, and as remote care models continue to proliferate and the need intensifies for big data to feed increasingly complex technologies, risks to health care providers will continue to abound.   In part one of this series, Sarah Carlins and Jianne McDonald discuss recent OCR recommendations for healthcare providers and patients on cybersecurity measures when providing and receiving care via telehealth. They also discuss the federal government’s view that effective communic

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 individual patient expanded access submissions, and the potential effects of the new proposed rule for lab developed tests.

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 adjust future payments as a purported countermeasure for its remedy payments, as well as the implications for ongoing Medicare Advantage plan disputes on the same issues.

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 providers participating in clinical studies. 

 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 contracts.

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 information, the implication of technical changes to certified electronic health record technology, and application of some of the Information Blocking Rule’s exceptions as well as offer recommendations for compliance.

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 compliance among hospitals, benefits of hospital price transparency data, antitrust considerations, and suggestions for hospitals to implement guidelines for clients when accessing data.

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 IRB’s in medical device clinical trials, sponsor obligations for investigator-initiated studies, and compliance for expanded access INDs and for GMPs in the case of hospital manufacturing of cell culture products and 3D printing.

In this episode, Rebecca Schaefer and J.D. Koesters review key components of the recent National Institute of Standards and Technology (NIST) revised publication regarding cybersecurity. They highlight how this resource incorporates NIST security lessons from other industries and maps the guidance to compliance requirements under the HIPAA Security Rule.

In this episode, Andrew Ruskin, Leah Richardson, and Victoria Hamscho analyze the U.S. Court of Appeals for the Fourth Circuit’s recent decision in Genesis Healthcare v. Becerra. They discuss its potential impact on the Health Resources and Services Administration’s definition of a 340B eligible patient in light of recent developments in the 340B Program and this year’s upcoming election.

In this episode, Stephen Bittinger and Nathan Huff discuss the growth of Medicare Part C (Medicare Advantage), new enforcements for Medicare Advantage Organization fraud, recent cases of False Claims Act liability, and key takeaways for Medicare Advantage Organizations and providers.