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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 ...
 
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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 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’ 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 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…
 
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…
 
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, 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 …
 
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…
 
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…
 
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…
 
Presenters: Gina Bertolini, Leah Richardson, Lindsey Rogers-Seitz In this week’s episode, Gina Bertolini, Lindsey Rogers-Seitz and Leah Richardson discuss a number of efforts undertaken by Congress and the U.S. Department of Health and Human Services (HHS) in recent weeks to expand the availability of telehealth services for the U.S. patient popula…
 
In this week’s episode, Limo Cherian, Carla Dewberry and Steven Pine discuss recent changes to value-based health care payment arrangements triggered by the current COVID-19 emergency. In particular, the presenters discuss changes implemented by CMS to the Quality Payment Program (QPP), the Merit-based Incentive Payment System (MIPS), and the Medic…
 
In this episode, Richard Church and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent COVID-19 guidance by the Health Resources and Services Administration and hospital requests for additional flexibilities to help them respond to the pandemic, particularly as it relates to eligibility requirements unde…
 
In this week’s episode, Mary Beth Johnston, Carolyn Merritt and Leah Richardson discuss the ways in which the Centers for Medicare and Medicaid Services’ (CMS) response to the ongoing COVID-19 outbreak is easing certain financial and compliance burdens on health care providers seeking agility in responding to the crisis. In particular, the presente…
 
In this week’s episode, Kenneth Kennedy discusses several of FDA’s strategies for helping stakeholders in the drug and medical device industry support health care providers in their fight against the COVID-19 outbreak. In particular, Mr. Kennedy discusses several unprecedented measures FDA has taken with respect to laboratory test approval, as well…
 
In this episode, Ryan Severson and Victoria Hamscho discuss recent developments in pharmaceutical pricing and the 340B Drug Pricing Program heading into 2020, including reimbursement cuts for 340B drugs under the Outpatient Prospective Payment System and the ongoing litigation challenging the cuts, 340B state action on discriminatory pricing, drug …
 
Beginning October 1, 2019, hospitals that are excluded from the Medicare Inpatient Prospective Payment System (IPPS), including psychiatric hospitals, children’s hospitals, and cancer hospitals, may now have IPPS-excluded rehabilitation or psychiatric units, provided these units meet the applicable Medicare rules for excluded units. In this episode…
 
In this week’s episode, Steve Pine presents the last installment of our three part series addressing the CMS Quality Payment Program (QPP) updates in the CY2020 Physician Fee Schedule (PFS) Proposed Rule. In this episode, Mr. Pine explains a number of Advanced Alternative Payment Models (APM) proposals, including new incentive structures and change…
 
This week’s episode is the second in an ongoing series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the confidentiality of substance use disorder treatment records in light of challenges posed by the opioid epidemic. In this episode, G…
 
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