Triage

In part two of this two-part series, Matt Miller and Andrew Lloyd analyze representations and warranties insurance (RWI) in the healthcare M&A landscape.

Matt Miller and Andrew Lloyd analyze representations and warranties insurance in the healthcare M&A landscape.

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 and how it led him to start The Davis Focus Project. They discuss the impact of traumatic brain injuries on special forces veterans and explore the latest advancements in treatment methods and emerging science for these complex conditions.

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 of care via telemedicine and other remote models has become heavily adopted: Corporate Practice of Medicine, or CPOM.

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 healthcare system.

Sarah Carlins and Jianne McDonald discuss recent OCR recommendations for healthcare providers and patients on cybersecurity measures when providing and receiving care via telehealth. 

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.

Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations.

Rebecca Schaefer and Martin Folliard discuss cybersecurity threats faced by healthcare organizations and a new federal research agency initiative to help create security tools to protect the US healthcare system from cyberattacks.

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. 

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.

Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials.

Sarah Carlins and Spencer Hamer discuss employment law and the healthcare sector highlights from 2022.

Andrew Ruskin, Darlene Davis, and Gabriel Scott discuss key provisions associated with conversion to CMS’s new rural emergency hospital provider type.

Norman Acker, Nora Becerra, and Katherine Rippey discuss the False Claims Act as it relates to Stark Law and the Anti-Kickback Statute. 

Victoria Hamscho, Andrew Ruskin, and Leah Richardson provide an update on key developments to the 340B Program.

In this episode, Gina Bertolini and Stephen Page discuss the most recent Information Blocking Rule compliance deadline.

Darlene Davis, Andrew Ruskin, and Lauren Norris Donahue review data that is now available in light of the hospital price transparency rule.

Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. 

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.

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. 

Stephen Bittinger and Nathan Huff discuss the growth of Medicare Part C (Medicare Advantage) and new enforcements for Medicare Advantage Organization fraud.

Gabriel Scott and Darlene Davis analyze the private payor rates reporting requirements under the Protecting Access to Medicare Act.

Steve Pine and Alexa Sengupta address the Centers for Medicare and Medicaid Services’ emerging focus on ESG and health equity priorities.

Rebecca Schaefer and Gina Bertolini discuss the incredible value of healthcare data and how providers can harness the power of data transactions. 

Myla Reizen, John Lawrence, and Bobby Higdon analyze the increase in governmental scrutiny around laboratory investigations and enforcement.

In this episode, Steven Pine and Gary Qualls discuss the arbitration provision under the federal No Surprises Act.

Andrew Ruskin and Gabriel Scott discuss how Centers for Medicare & Medicaid Services (CMS) has recently promulgated rules implementing the provisions of the Consolidated Appropriations Act that affect a very large number of community hospitals. 

Desiree Moore, Gina Bertolini, and Jackie Hoffman discuss the increasing impact of data security incidents and security breaches on the healthcare sector.

Richard Church interviews Michael Hinckle about FDA inspections of healthcare providers.

In this week’s episode, Darlene Davis interviews Andrew Ruskin about updates to the CMS Hospital Price Transparency rule now that it has been in effect for almost one year.

In this episode, Rebecca Schaefer interviews Gina Bertolini and Desiree Moore about the recent Federal Trade Commission (FTC) policy statement regarding the FTC Health Breach Notification Rule and its applicability to vendors of personal health records.

Leah D’Aurora Richardson and Sarah Staples explain what remote therapeutic monitoring (RTM) is, how it is different from remote physiologic monitoring (RPM), and the uncertainty regarding which practitioners will be able to furnish and bill for RTM services.

Gina Bertolini, John Lawrence, and David Rybicki discuss why healthcare providers in particular are being targeted by threat actors, how providers can help protect themselves against this risk, and how providers should react in the event a cybersecurity attack occurs.

Richard Church interviews Rebecca Schaefer about the intersection and blurred line between clinical research and quality initiatives. The presenters discuss what factors to consider when defining research, the regulatory requirements for research, and HIPAA exemptions to the Common Rule. 

Sarah Carlins and Jackie Hoffman interview Craig Leen, former director of the Office of Federal Contract Compliance Programs (OFCCP) at the U.S. Department of Labor, about OFCCP enforcement in the healthcare industry.

In this week’s episode, Josh Skora interviews Rick Giovannelli and Ken Marlow about current trends in healthcare transactions.

Richard Church and Andrew Ruskin discuss recent developments in the landscape of the 340B Drug Pricing Program.

In this week’s episode, Richard Church and Mary Beth Johnston discuss a number of critical issues in the healthcare 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, healthcare consolidation, and more.

In this episode, Healthcare partner Rebecca Schaefer interviews Karishma Page, partner in the firm’s Public Policy and Law practice group, on what is likely to be coming down the pike in the healthcare policy landscape of particular interest to academic medical centers vis-à-vis regulatory and legislative action in 2021.  

Gina Bertolini discusses two important aspects of the CMS Interoperability and Patient Access Final Rule that directly relate to healthcare providers, and how those aspects of the Final Rule will intersect with healthcare providers’ obligations under the ONC Information Blocking Rule.

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.

Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program.

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.

John Lawrence, Leah Richardson, and John Rothermich discuss compliance requirements associated with federal funding provided to healthcare providers through the CARES Act Provider Relief Fund, as well as the potential for forthcoming enforcement actions under the Federal False Claims Act.

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.

Limo Cherian, Steve Pine, and Macy Flinchum discuss some of the key changes for Accountable Care Organizations in the recent Medicare Physician Fee Schedule proposed rule.

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 final rule implementing the Interoperability, Health IT Certification and Information Blocking requirements under the 21st Century Cures Act. 

Carla DewBerry and Kelsey Jernigan discuss issues in mental health parity in the context of recent California legislation. 

Leah D’Aurora Richardson and Victoria Hamscho discuss next month’s Supreme Court oral arguments in Rutledge v. Pharmaceutical Care Management Association.

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.

Rebecca Schaefer and Hannah Maroney discuss a string of recent HIPAA enforcement actions which demonstrate that the HHS Office of Civil Rights is increasingly focused on ensuring that affiliated hospitals within a health system have HIPAA business associate agreements in place with the parent corporation to allow for the lawful exchange of PHI.

Darlene Davis, Andrew Ruskin, and Gabriel Scott discuss notable recent developments for reimbursement under the Hospital Outpatient Prospective Payment System of drugs purchased under the 340B Drug Pricing Program. 

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.

Richard Church, Andrew Ruskin, and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program.

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.

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.

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.

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.

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.

Leann Walsh identifies key takeaways for hospitals and other healthcare employers from a guidance document recently published by the Centers for Disease Control entitled “Ten Ways Healthcare Systems Can Operate Effectively during the COVID-19 Pandemic.”

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 in recent weeks to expand the availability of telehealth services for the U.S. patient population in order to prevent unnecessary patient-provider contact and help combat the spread of COVID-19.

In this week’s episode, Limo Cherian, Carla Dewberry and Steven Pine discuss recent changes to value-based healthcare payment arrangements triggered by the current COVID-19 emergency.

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 under the 340B Program.

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 healthcare providers seeking agility in responding to the crisis.

In this week’s episode, Gary Qualls discusses the recent Louisiana federal district court decision in Crescent City Surgical Centre vs.

In this week's episode, Limo Cherian, Carla Dewberry, and Steve Pine discuss EKRA - the 'Eliminating Kickbacks in Recovery Act of 2018,' which introduces new criminal penalties for kickbacks associated with referrals to recovery homes, clinical treatment facilities, and laboratories.

In this episode, Macy Flinchum and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent guidance by the Centers for Medicare and Medicaid Services on best practices for states to avoid duplicate discounts in Medicaid Fee-for-Service and Medicaid Managed Care Organization programs.

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 pricing reform, International Pricing Index and Safe Drug Importation Action Plan, and pharmacists’ provider status under Medicare.

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.

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.

This episode is the first in a series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R.

In this week’s episode, Limo Cherian presents the first segment of a three part series addressing the Centers for Medicare & Medicaid Services (CMS) Quality Payment Program (QPP) updates in the CY2020 Physician Fee Schedule (PFS) Proposed Rule.

On this week’s episode, George Summerfield and Kelly Plummer explore five key questions academic medical centers often face with respect to patent ownership and enforcement.

*UPDATE* Since initial publication of this episode, CMS has delayed implementation of this policy until April 2020.

In this episode, Gary Qualls provides an overview of a recent case out of the Fifth Circuit Court of Appeals, Encompass Office Solutions, Inc. v. Louisiana Health Service & Indemnity Company d/b/a BlueCross BlueShield of Louisiana.

In Part Two of this two-part series on the current climate of sexual harassment within the healthcare industry, Leann Walsh and Kristi Nickodem discuss important considerations and practical tips for healthcare employers in light of the National Academies of Sciences, Engineering and Medicine’s recent report on Sexual Harassment of Women: Climate, Culture and Consequences in Academic Sciences, Engineering and Medicine.

With the recent launch of Time's Up Healthcare and the publication of the National Academies of Sciences, Engineering and Medicine’s Sexual Harassment of Women: Climate, Culture and Consequences in Academic Sciences, Engineering and Medicine (“National Academies’ Report”), sexual harassment continues to be an important topic of conversation within the healthcare industry.

In this episode, Rebecca Schaefer discusses the impact of this revised regulatory interpretation, how the new standard may impact pending disputes, and overall trends affecting HIPAA judgments and settlements.

In this episode, Michael McKay and Carla DewBerry discuss the practical implications of responding to an investigative inquiry by governmental officials.

In this episode, Gary Qualls discusses a recent development in payer litigation which implicates a number of recurring issues often raised in Employee Retirement Income Security Act (ERISA) cases.

As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Healthcare Professionals, Hilary Bowman previews several topics that the healthcare practice group anticipates will have a significant impact on healthcare in 2019.

In Part 3 of our series on healthcare investigations, Mark Rush and John Lawrence discuss the process for external investigations conducted by federal and state governmental agencies, including in the context of qui tam actions arising under the False Claims Act.

In Part 2 of our series on healthcare investigations, Mark Rush and John Lawrence continue the discussion on internal investigations.

In this episode, Mark Rush and John Lawrence discuss the federal government’s expectations related to healthcare organizations conducting internal investigations and demonstrating a commitment to compliance.

In this episode, Margaret Westbrook provides a basic overview of the Chapter 11 sales process and how this process can be utilized as an advantageous method of buying and selling healthcare businesses.

The Centers for Medicare & Medicaid Services (“CMS”) recently proposed a major redesign of its Medicare Shared Savings Program (“MSSP”) under a new plan it calls “Pathways to Success.” In this Part I of a two-part series on the proposed MSSP changes, Limo Cherian discusses the structural changes included in the proposal and how these changes would affect current risk-sharing models. About Triage Triage: Rapid Legal Lessons for Busy Healthcare Professionals has been created by K&L Gates to convey information about developments in health law through short podcasts.

In this episode, Michael Hinckle summarizes current requirements for single shared system (SSS) REMS and explains how the new guidance documents may assist generic drug applicants negotiating SSS issues with brand competitors.

In light of the recent #MeToo movement and ongoing public discourse regarding workplace culture, employers in the healthcare industry are increasingly seeking creative ways to improve their own workplace culture, such as organizing internal committees to boost employee morale and to create a safe space for employees to voice concerns.

In this episode, Gary Qualls discusses a recent development in payer litigation, regarding a provider’s recovery of Medicare Advantage payments pursuant to a Medicare Advantage contract.

In this episode, Mark Rush and John Lawrence discuss some of the major trends of the takedown, including a focus on unlawful distribution of opioids and other prescription narcotics and a focus on holding individuals accountable, as well as practical takeaways from the takedown for those in the healthcare industry.

The Centers for Medicare & Medicaid Services (“CMS”) recently proposed certain changes to the existing satellite facility rules in its Inpatient Prospective Payment System (“IPPS”) and Long Term Acute Care Hospital (“LTCH”) Prospective Payment System proposed rule for fiscal year 2019.

In the second segment of this two-part series discussing recent program changes introduced by the Bipartisan Budget Act of 2018 for Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP), Kathy Barger discusses new improvements in telehealth coverage for certain ACOs and new beneficiary incentive opportunities for qualifying primary care services.

In this episode, Margaret Westbrook discusses privacy issues that may affect healthcare providers when filing proofs of claim in the bankruptcy court.

In the fifth episode of our series on the national opioid crisis, Hilary Bowman discusses the Drug Enforcement Administration’s (DEA) role in regulating individuals and entities handling controlled substances, including opioids.

In the fourth episode of our series on the national opioid crisis, Ruth Granfors and Tracy Lawless discuss how opioid treatment is reimbursed under Medicaid and other public programs.

In the third episode of our series on the national opioid crisis, Amanda Makki and Corbin Santo provide an overview of how the Trump Administration and Congress may address the opioid epidemic this year.

In the second episode of our series on the national opioid crisis, Gina Bertolini discusses the overlay of recent guidance concerning privacy laws such as the Health Insurance Portability and Accountability Act (HIPAA) and the Confidentiality of Substance Use Disorder Patient Records (Part 2) regulations and how they are interpreted with regard to opioid treatment.

This is the first episode in a series focused on the legal issues surrounding the nationwide opioid crisis.

We expect 2018 to be another year of rapid change within the healthcare industry.

In this episode, Hilary Bowman summarizes recent updates to the U.S. Department of Health & Human Services, Office of Inspector General (OIG) 2017 Work Plan. 

In this latest episode on drones in healthcare, Tom DeCesar discusses how an increase in the prevalence of drone use may complicate existing healthcare operations, particularly through the disruption of air ambulances and the protection of patient privacy in and around healthcare facilities.

In this episode of Triage, Amanda Makki and Corbin Santo of the K&L Gates Public Policy and Law practice group discuss several fundamental issues that are currently at the center of the healthcare debate in Washington, DC.

Unmanned aircraft, commonly known as “drones,” are gaining traction as a tool used by many industries today, including healthcare.

This episode explains the proposed changes to the site-neutral payment rule for off-campus hospital outpatient departments for CY 2018, as discussed in both the recent Hospital Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) proposed rules.

This episode discusses the risks associated with mandatory employee vaccination programs and practical tips for healthcare entities on how to minimize these risks from an employment law perspective.

This episode explores the proposed changes to the hospital within a hospital (“HwH”) rules, which were published in the Federal Register on April 14, 2017 as part of the Fiscal Year 2018 Medicare Hospital Inpatient Prospective Payment System and Long Term Acute Care Hospital Prospective Payment System Proposed Rule.