Triage: Timely Conversations for Health Care Professionals is a podcast created by the K&L Gates Health Care practice group to inform our clients and friends of the firm about the latest developments in health law. If you would like to provide feedback or would like to suggest a topic for a future episode of Triage, please contact us. Catch up on past episodes by visiting our program page.
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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 health care industry.
Richard Church interviews Stephen Bittinger about the scope and authority of OIG and CMS audits, outlining the similarities and differences between the two from a provider perspective.
In this episode, Richard Church interviews Teresa Hill about the history and structure of power purchase agreements and the opportunities that these transactions can bring for the health care industry.
Richard Church interviews Stephen Bittinger about current trends and points of concern in the areas of health care reimbursement and integrity audit activity.
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.
In this week’s episode, Josh Skora interviews Rick Giovannelli and Ken Marlow about current trends in health care transactions.
Richard Church and Andrew Ruskin discuss recent developments in the landscape of the 340B Drug Pricing Program.
Jackie Hoffman interviews Spencer Hamer about recent developments in employment law that have impacted the health care industry.
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 in 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.
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.
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 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.
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.
Jackie Hoffman addresses the challenges of providers to identify available resources and maximize reimbursement in the face of the costs of care of uninsured and underinsured patients with COVID-19.
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.
Stephen Bittinger discusses the recent announcement that cease and desist letters from the Centers for Medicare & Medicaid Services have been sent to 171 facilities testing for COVID-19 without proper CLIA certifications.
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.
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.
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.
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.
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.
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.
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.
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 health care 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 health care 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 health care providers seeking agility in responding to the crisis.
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 this week’s episode, Hannah Maroney, Cheryl Choice and Steven Pine provide some background on COVID-19 and discuss challenges health care providers may face with respect to the disclosure of protected health information related to COVID-19 patients under HIPAA, as well as recent guidance issued by the Department of Health and Human Services Office of Civil Rights (OCR) related to such disclosures.
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, Adam Cooper discusses the Supreme Court’s decision in Azar v. Allina Health Services, as well as a related memorandum issued in late 2019 by the Centers for Medicare and Medicaid Services (“CMS”) that addresses the ways in which the Allina decision augmented notice and comment rulemaking requirements with respect to certain types of regulatory guidance issued by CMS.
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 week’s episode, Ryan Severson discusses the Federal Health IT Strategic Plan, which was recently released by the Office of the National Coordinator for Health Information Technology (“ONC”).
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 week's episode, Lindsey Rogers-Seitz forecasts a number of critical issues spanning the health care industry that are likely to be points of focus in the coming year.
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.
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.
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, Kathy Barger presents the second in a three part series addressing the CMS Quality Payment Program (QPP) updates in the CY2020 Physician Fee Schedule (PFS) Proposed Rule.
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.
In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program, including discussion of the ongoing federal litigation challenging reimbursement cuts on 340B drugs under the Medicare Outpatient Prospective Payment System (OPPS), the status of the Health Resources and Services Administration’s (HRSA’s) 340B Civil Monetary Penalties (CMP) Rule and Ceiling Price Site, and recent developments in the litigation between HRSA and Genesis Health Care.
In Part One of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments that may affect drug pricing and pharmacy regulation on a national level, including a discussion of the Trump Administration’s proposed International Pricing Index (IPI) Model, the recently announced FDA Safe Drug Importation Plan, and developments in ongoing litigation surrounding CMS’ price disclosure rule for direct-to-consumer drug advertisements.
*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 health care 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 Health Care 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 health care industry.
The Office of the National Coordinator for Health Information Technology (ONC) recently released a proposed rule aimed at promoting the interoperability of health information technology and enabling access to electronic health information (EHI).
In this episode, Richard Church and Spencer Hamer discuss key takeaways for the health care industry upon certain developments in labor and employment law over the past year.
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 Health Care Professionals,Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on health care in 2019.
This is the final episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC.
This is the second episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC.
This is the first episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC.
In Part 3 of our series on health care 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 health care 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 health care organizations conducting internal investigations and demonstrating a commitment to compliance.
In a recent decision, the Northern District of Texas, Dallas Division, granted a health care provider a preliminary injunction to prevent the Centers for Medicare & Medicaid Services ("CMS") from withholding Medicare payments due to an alleged overpayment while the provider awaits its Administrative Law Judge ("ALJ") hearing on the issue.
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 II of the two-part series on the proposed MSSP changes, Steve Pine discusses changes to ACO benchmarking, beneficiary notifications, and EHR certifications.
A sale of a business under Section 363 of the U.S.
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 Health Care Professionals has been created by K&L Gates to convey information about developments in health law through short podcasts.
In light of the recent #MeToo movement and ongoing public discourse regarding workplace culture, employers in the health care 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.
Recently, the U.S.
Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in various industries today.
In September 2017, the Centers for Medicare & Medicaid Services (CMS) released a Survey and Certification memo which created interpretive guidelines for compliance with the statutory requirement that hospitals be “primarily engaged” in providing inpatient care.
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.
Pharmacy Benefit Managers (PBMs) are increasingly utilizing gag clauses in pharmacy contracts as a means of prohibiting pharmacies from telling customers that paying for drugs out of pocket would cost them less than if they used their insurance and paid their copays.
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.
The Bipartisan Budget Act of 2018 recently introduced three noteworthy program improvements for Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP) aimed at increasing program flexibility.
In the midst of the ongoing federal conversation surrounding the 340B Drug Pricing Program, individual states are implementing a number of regulatory efforts related to the 340B Program at an increasingly fast pace.
Transportation is often cited as one of the top barriers to health care for individuals in the United States.
In this episode, Margaret Westbrook discusses privacy issues that may affect health care providers when filing proofs of claim in the bankruptcy court.
In this episode, Bridget Blinn-Spears discusses sexual harassment issues for health care employers in the wake of the #MeToo movement.
In the seventh episode of our series on the national opioid crisis, Erica Jackson discusses efforts by the U.S.
In the sixth episode of our series on the national opioid crisis, Lauren Perry discusses some of the legal obligations for providers who prescribe controlled substances as treatment for substance abuse disorders.
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 health care industry.
In this episode,Hilary Bowmansummarizes recent updates to the U.S.
In this episode, Erica Jackson discusses recent guidance from the Food & Drug Administration (FDA) on the consideration of real-world data and real-world evidence in regulatory decision-making related to medical devices and their development.
This episode of Triage provides an overview for employers of the current state law landscape and federal enforcement priorities regarding marijuana use for recreational and medical purposes.
In this latest episode on drones in health care, Tom DeCesar discusses how an increase in the prevalence of drone use may complicate existing health care operations, particularly through the disruption of air ambulances and the protection of patient privacy in and around health care facilities.
In this episode, Richard Church and Ryan Severson discuss the recent decision by the Centers for Medicare and Medicaid Services (CMS) to substantially decrease reimbursement under the Outpatient Prospective Payment System (OPPS) for Medicare Part B drugs purchased pursuant to the 340B Drug Discount Program beginning January 1, 2018.
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 health care debate in Washington, DC.
In the final episode of our three-part series on emergency preparedness and response in long term care, Kimi Gordy sits down with Sara Hamm, Senior Vice President of Successful Aging & Health Services for Lifespace Communities, to discuss disaster recovery and fostering resilience in long term care communities.
Unmanned aircraft, commonly known as “drones,” are gaining traction as a tool used by many industries today, including health care.
This is the second episode in a three-part series on emergency preparedness and response in long-term care.
This is the first episode in a three-part series on emergency preparedness and response in long-term care.
This episode provides an overview of the major cyber security issues affecting the health care industry.
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 a recent policy shift by the Centers for Medicare & Medicaid Services (CMS) regarding binding pre-dispute arbitration clauses in long-term care resident agreements over the course of the past year.
This episode discusses the risks associated with mandatory employee vaccination programs and practical tips for health care entities on how to minimize these risks from an employment law perspective.
This episode outlines the basics of the 340B Drug Pricing Program and discusses potential changes affecting the program, including CMS’s recent proposal to cut reimbursement for Part B drugs purchased under the 340B program.
This episode discusses some of the emerging themes and challenges that many hospitals are facing with the increasing number of psychiatric patients presenting to their emergency departments.
This episode discusses the U.S. Department of Labor’s recent decision to withdraw agency guidance on independent contractors in June 2017.
This is the third episode in a series on recent revisions to the Federal Policy for the Protection of Human Subjects, better known as the “Common Rule.” This episode focuses on secondary research, when it is subject to the Common Rule as finalized, and how institutions may utilize the broad consent option to authorize such secondary research to be conducted in the future.
This is the second episode in a series on recent revisions to the Federal Policy for the Protection of Human Subjects, better known as the “Common Rule.” This episode discusses changes to informed consent requirements for human subject research and what types of research may be exempt from such requirements.
This is the second segment in a Labor, Employment and Workplace Safety series discussing the creation of a new “Joint Employer Test” by the Fourth Circuit Court of Appeals and how it impacts health care entities in North Carolina, South Carolina, Maryland, Virginia and West Virginia.
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.
This is the third segment in a series on Revising, Repealing or Replacing the ACA.