K&L Gates Healthcare Triage

In this week's episode, Myla Reizen interviews Bruce Spurlock, quality expert and President and CEO of Cynosure Health, about long-term care facilities focusing on lessons learned over the past year with COVID-19, with a deep-dive into a recent survey of California nursing homes and key take-aways. The presenters also address current issues facing the industry including top-of-mind concerns with v...

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 presenters also discuss how changes in the political landsc...

In this episode, Richard Church and Andrew Ruskin discuss recent developments in the landscape of the 340B Drug Pricing Program in 2020, and forecast some of the major areas of focus and potential change for 340B covered entities under the new administration in 2021 and beyond.

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 health threat. This episode of Triage is recorded in c...

In this week's episode, Richard Church and Mary Beth Johnston discuss a number of critical issues in the health care industry that are likely to be points of focus in the coming year, including the COVID-19 pandemic, False Claims Act cases, the Affordable Care Act, health care consolidation, and more.

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. 

  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' public reporting requirements for clinicians and hos...

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 ways in which the insurer's inadequate internal gui...

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 Administration (HRSA) to promulgate 340B administrative d...

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 and insights on the impact of COVID-19 on research...

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 discuss the general confusion surrounding the gra...

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 from this trend.

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 providers and other stakeholders as well as the curren...

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 implications for reimbursement of COVID-19 testing. Pr...

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 developments in Florida and Texas. Presenters: Myla Reizen a...

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 metrics on which ACOs are scored are finalized for 2021...

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 Blocking requirements under the 21st Century Cures Ac...

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 presenters further address trends across the federa...

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 ways in which OIG is likely to scrutinize the use of...

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 from engaging in two-tier pricing models in regard...

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 requirements, as well as the penalties responsible parties m...

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 (ACE), have HIPAA business associate agreements in...

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 Hospital Association v. Azar , as well as certain...