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Triage: Rapid Legal Lessons for Busy Health Care Professionals has been created by K&L Gates to convey information about developments in health law through short podcasts. If you work in the health care industry, you have grown accustomed to frequent changes in laws and regulations. On some days, it may seem like an insurmountable task to keep up with every change, especially as a new presidential administration and new policies take shape. The K&L Gates Health Care practice will regularly c ...
 
Keeping up with legal and regulatory issues and industry trends that impact your business both locally and globally can be challenging. Whether you are in a legal department or are a C-suite executive, you must navigate ever-changing laws and regulations. HUB Talks, a podcast launched by K&L Gates, covers critical issues at the intersection of business and law. Tune in to HUB Talks for insight from K&L Gates lawyers that will help you stay on top of the latest industry and legal trends acros ...
 
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show series
 
In this week’s episode, Josh Skora interviews Rick Giovannelli and Ken Marlow about current trends in health care transactions, with a particular focus on how COVID-19 has affected pricing considerations and the appetite for mergers, acquisitions, and joint ventures for traditional health care providers and private equity firms alike. The presenter…
 
In this episode, Jackie Hoffman interviews Spencer Hamer about recent developments in employment law that have impacted the health care industry. This episode touches on various topics, including COVID-19 screening at the workplace, vaccination requirements, family member and whistleblower claims, physician non-competes, and racism as a public heal…
 
In this second episode of our series on the government's response to the Paycheck Protection Program, white collar practitioners Chris Nasson, David Rybicki, Neil Smith, and Hayley Trahan-Liptak discuss the second phase of enforcement actions that are expected from the government, what the government may be looking for when reviewing borrower's PPP…
 
Throughout the month of February, we celebrate Black History Month in the United States. On this episode of Talking Sports Law with K&L Gates, NCAA Chief Operating Officer and Chief Legal Officer Donald Remy joins hosts Trevor Gates, Matt Clark, and John Wilson for a conversation about the intersection of race and sports law. Donald discusses his u…
 
In this first episode of our series on the government's response to the Paycheck Protection Program, white collar practitioners Chris Nasson, David Rybicki, Neil Smith, and Hayley Trahan-Liptak provide an overview of the program, identify issues that arose with the roll out of the program, and discuss the first phase of the government's enforcement…
 
In this episode, Health Care partner Rebecca Schaefer interviews Karishma Page, partner of the firm’s Public Policy and Law practice group, on what is likely to be coming down the pike in the health care policy landscape of particular interest to academic medical centers vis-à-vis regulatory and legislative action in 2021.…
 
Have you ever wondered what is required to win the rights to host one of the world’s largest sporting events? On this episode of Talking Sports Law, we provide you with an “insider’s view” of a successful World Cup hosting bid with Football Australia Chairman and K&L Gates partner Chris Nikou. Australia and New Zealand were recently selected as hos…
 
On this episode of Talking Sports Law from K&L Gates, the featured guest is Malte Vosteen, general counsel of Bepro, an innovative sports technology company (and client of K&L Gates). Bepro is primarily focused on the sport of soccer, and the company helps clubs and players measure, understand, and improve performances through video and data. Bepro…
 
On this episode of Talking Sports Law from K&L Gates, hosts John Wilson and Trevor Gates are joined by Randy Haight, General Counsel of Los Angeles FC from Major League Soccer. Randy describes his background in prior roles with Red Bull, Funny or Die, and the LA Clippers, discusses the impact of COVID-19 on LAFC and the sports world as a whole, and…
 
In this week’s episode, Gina Bertolini discusses two important aspects of the CMS Interoperability and Patient Access Final Rule that directly relate to health care providers, and how those aspects of the Final Rule will intersect with health care providers’ obligations under the ONC Information Blocking Rule. Specifically, Gina discusses CMS’ publ…
 
On this week’s episode, Carla DewBerry and Sarah Carlins discuss a recent California Federal District Court decision in David Wit v. United Behavioral Health, in which the court found that the defendant insurer violated ERISA by improperly denying behavioral health claims submitted by over fifty thousand beneficiaries. The presenters discuss the wa…
 
In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug manufacturer contract pharmacy actions where they are requesting, among other things, for the Health Resources and Services Adminis…
 
In this episode, Rebecca Schaefer and Victoria Hamscho discuss the impact of the ongoing COVID-19 pandemic on university research programs and public policy projections for a potential federal response. The presenters are joined by Robin Cyr, Vice Provost for Research Administration at Northeastern University, who shares her frontline perspective a…
 
On this week’s episode, John Lawrence, Leah Richardson, and John Rothermich discuss compliance requirements associated with federal funding provided to health care providers through the CARES Act Provider Relief Fund, as well as the potential for forthcoming enforcement actions under the Federal False Claims Act (FCA). In particular, the presenters…
 
In this week’s episode, Kenneth Kennedy discusses FDA’s ongoing focus on the issuance of warning letters to firms marketing fraudulent COVID-19 products, and to manufacturers who have failed to meet certain requirements under applicable FDA Emergency Use Authorizations (EUAs), as well as what manufacturers and health care providers alike can learn …
 
In this episode, Jackie Hoffman addresses the challenges of providers, and those who advise providers, to identify available resources and maximize reimbursement in the face of the costs of care of uninsured and underinsured patients with COVID-19, or where providers generally face reimbursement challenges due to the pandemic environment.…
 
In this episode, Rebecca Schaefer and Victoria Hamscho provide an update on next month’s Supreme Court oral arguments in California v. Texas, a case in which the Court will be reviewing the constitutionality of key parts of the Affordable Care Act (ACA). The presenters discuss the potential impact of the Supreme Court’s decision on health care prov…
 
In this episode, Stephen Bittinger discusses the recent announcement that cease and desist letters from the Centers for Medicare & Medicaid Services (CMS) have been sent to 171 facilities testing for COVID-19 without proper CLIA certifications. Stephen outlines the impact of these cease and desist letters to the facilities, including potential impl…
 
In this week’s episode, Myla Reizen and Jackie Hoffman discuss recent developments on the state and federal level related to the operation of long-term care facilities in light of the ongoing COVID-19 public health emergency. In particular, the presenters discuss recent federal regulatory and executive actions, as well as important state developmen…
 
In this week’s episode, Limo Cherian, Steve Pine, and Macy Flinchum discuss some of the key changes for Accountable Care Organizations (ACOs) in the recent Medicare Physician Fee Schedule proposed rule. In particular, the presenters discuss the implications and potential challenges for ACOs if the proposed changes to quality reporting and the metri…
 
In this episode, we examine how two criminal defendants are aiming to leverage parallel FCPA investigations by the SEC and the DOJ to build their defense. We’ll also offer our thoughts on the SEC’s new (and improved?) whistleblower program and the Office of Management and Budget’s recent guidance on enforcement in the time of COVID-19. Finally, we’…
 
In this week’s episode, Gina Bertolini, Lindsey Rogers-Seitz and Maggie Power discuss the Preventing Harm Exception to the Information Blocking Rule, which was recently finalized in the Office of the National Coordinator for Health Information Technology (ONC) final rule implementing the Interoperability, Health IT Certification and Information Blo…
 
In this week’s episode, Carla DewBerry and Kelsey Jernigan discuss issues in mental health parity in the context of recent California legislation. In particular, the presenters discuss how a new California bill has sparked a renewed discussion on parity for mental health and substance use disorder treatment and how it should work in practice. The p…
 
Join hosts John Wilson and Trevor Gates for a casual conversation with Tennessee Titans General Counsel Dan Werly. Dan will describe his path to the Titans, his thoughts on the impact of COVID-19 and provide a first-hand account of his experience helping new MLS club Nashville SC receive approval to build a new state-of-the-art soccer stadium. Dan …
 
In this week’s episode, Matt Hubbell and Stephen Bittinger discuss the addition of two new items to the Department of Health and Human Services Office of the Inspector General (OIG) work plan: auditing of COVID-19 related reimbursement during the public health emergency, and auditing of CARES Act provider relief funds. The presenters discuss the wa…
 
A government inquiry can result in serious consequences for a company or individual. Our new podcast series, Voluntary Disclosure—brought to you by the lawyers in our investigations, enforcement, and white collar practice—is designed to keep you up to date with the latest government enforcement news with our bi-weekly Newsflash episodes, as well as…
 
In this episode of Triage, Leah D’Aurora Richardson and Victoria Hamscho discuss next month’s Supreme Court oral arguments in Rutledge v. Pharmaceutical Care Management Association, including its potential impact on nearly forty state laws that regulate the conduct of pharmacy benefit managers (PBMs) and at least nine state laws prohibiting PBMs fr…
 
In this episode of Voluntary Disclosure, Chris Nasson and David Peet trace the history of the DOJ’s China Initiative at U.S. academic research institutions, and explain why researchers and institutional leadership find themselves in the crosshairs of a variety of government stakeholders. They also discuss the political implications of past enforcem…
 
In this episode, Mary Beth Johnston and Nora Becerra discuss recent COVID-19 federal data and the disparate impact of the disease on ethnic and racial minorities; they examine the data through the lens of social determinants of health and propose potential solutions moving forward.
 
FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On this week’s episode, Lindsey Rogers-Seitz and Kenneth Kennedy discuss the scope of FDA’s clinicaltrials.gov reporting requiremen…
 
In this week’s episode, Rebecca Schaefer and Hannah Maroney discuss a string of recent HIPAA enforcement actions which demonstrate that the HHS Office of Civil Rights (OCR), the agency tasked with enforcing HIPAA, is increasingly focused on ensuring that affiliated hospitals within a health system, typically comprising an Affiliated Covered Entity …
 
Join co-hosts John Wilson and Trevor Gates for an entertaining and informative conversation with Seattle Seahawks Associate Counsel Alen Cisija. Topics include Alen’s path to an in-house legal role with the Seahawks, the impact of COVID-19, predictions for sports law trends in the upcoming year, and Alen’s recommendation for the world’s best chicke…
 
In this week’s episode, Darlene Davis, Andrew Ruskin, and Gabriel Scott discuss notable recent developments for reimbursement under the Hospital Outpatient Prospective Payment System (“OPPS”) of drugs purchased under the 340B Drug Pricing Program. In particular, the presenters discuss the implications of the recent D.C. Circuit decision in American…
 
In this week’s episode, Gary Qualls discusses a recent case decided in the Western District of Louisiana, which highlights how the application of the arbitrary and capricious standard as applied to payor coverage determinations can, in some instances, favor the patient. Mr. Qualls discusses how this case was decided and what providers can learn fro…
 
A government inquiry can result in serious consequences for a company or individual. Our new podcast series, Voluntary Disclosure—brought to you by the lawyers in our investigations, enforcement, and white collar practice—is designed to keep you up to date with the latest government enforcement news with our bi-weekly Newsflash episodes, as well as…
 
In this episode, Richard Church, Andrew Ruskin, and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent actions by drug manufacturers to limit contract pharmacy access to 340B pricing and impose new reporting requirements on 340B covered entities, as well as a new legislative proposal that would temporari…
 
In this week’s episode, Stephen Bittinger discusses the impending resumption of Medicare error-based audits, which were temporarily suspended following the onset of the COVID-19 crisis. Mr. Bittinger discusses the different forms of audits that are set to resume, potential focus points that auditors may target, and measures providers should take to…
 
A government inquiry can result in serious consequences for a company or individual. Our new podcast series, Voluntary Disclosure—brought to you by the lawyers in our investigations, enforcement, and white collar practice—is designed to keep you up to date with the latest government enforcement news with our bi-weekly Newsflash episodes, as well as…
 
In this week's episode, Gabe Scott and Steve Pine discuss recent data showing how health systems participating in Alternative Payment Models compare to other health systems in responding to the COVID-19 crisis, and discuss the future of APMs. Presenters: Steve Pine, Gabe Scott
 
In this week’s episode, Myla Reizen and Paris Petranis are joined again by Bruce Spurlock, President and CEO of Cynosure Health, and Judi Coombe, a Senior Operations Consultant at Ansell Strategic, to continue their discussion of the effects of the COVID-19 pandemic on nursing homes and long term care facilities in the United States and Australia. …
 
In this week’s episode, Carla DewBerry is joined by with Carlos Olivares, Executive Director of the Yakima Valley Farm Workers Clinic, a community based health center in the Pacific Northwest serving low-income, migrant and seasonal farm workers and communities of color for over 40 years. Ms. DewBerry and Mr. Olivares discuss how the COVID-19 pande…
 
In this week’s episode, Myla Reizen and Paris Petranis are joined by Bruce Spurlock, President and CEO of Cynosure Health, and Judi Coombe, a Senior Operations Consultant at Ansell Strategic, to discuss the effects of the COVID-19 pandemic on nursing homes and long term care facilities in the United States and Australia. The presenters discuss the …
 
On this week’s episode, John Lawrence, Myla Reizen and Mark Rush discuss the devastating effects COVID-19 has had on nursing homes and long term care facilities in the United States and potential civil and criminal liability that may stem from how nursing homes and long term care facilities have responded. In particular, the presenters discuss guid…
 
In this week’s episode, Carla Dewberry, Sarah Carlins, and Cheryl Choice discuss the ways in which the COVID-19 emergency has changed the landscape of behavioral health in the United States. The presenters address the ways in which the COVID-19 emergency has affected behavioral health providers and the ways in which they offer behavioral health ser…
 
In this week’s episode, Leann Walsh identifies key takeaways for hospitals and other health care employers from a guidance document recently published by the Centers for Disease Control (CDC) entitled “Ten Ways Healthcare Systems Can Operate Effectively during the COVID-19 Pandemic.” In particular, Ms. Walsh discusses CDC guidance related to worker…
 
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