K&l Gates Health Care Triage

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 to the 340B Drug Pricing Program. Presenters: Leah D’Aurora Richardson, Victoria K. Hamscho

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 may face for failing to meet them. Presenters: Lindsey Rogers-Seitz and Kenneth Kennedy

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 place with the parent corporation to allow for the lawful exchange of PHI. The presenters discuss the circumstances in which a business associate agreement may be required, and address several questions regarding related ACE organizational considerations. Presenters: Rebecca Schaefer, Hannah Maroney

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 provisions of the new OPPS proposed rule released by CMS on August 4, 2020. Presenters: Andrew Ruskin, Darlene Davis, Gabe Scott

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 from the court’s reasoning.

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 temporarily waive 340B hospital eligibility requirements. Presenters: Richard Church, Andrew Ruskin, Victoria Hamscho

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 prepare. Download Presentation Materials

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. This week, the presenters focus on the ways in which regulatory authorities and industry leaders in the United States and Australia may adapt and change the face of long term and aged care as the COVID-19 pandemic continues, and beyond. Presenters: Myla Reizen and Paris Petranis Download Presentation Materials  

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 pandemic has impacted the organization and community at large, as well as the innovative projects the Yakima Valley Farm Workers Clinic has undertaken, and potential changes in the health care delivery system in years to come. Presenter: Carla DewBerry

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 full scope of issues COVID-19 has created for the long term and aged care industries to date, and the ways in which regulatory authorities and industry leaders are addressing these issues in both the United States and Australia. Presenters: Myla Reizen and Paris Petranis Download Presentation Materials

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 guidance the United States government has provided to nursing homes and long term care facilities for handling the COVID-19 pandemic, areas of potential exposure to criminal and civil actions for nursing homes and long term care facilities related to their response to the pandemic, and what protective measures such facilities can take to prevent or defend against such civil and criminal actions.

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 services, as well as how some of these changes may continue to affect the field of behavioral health into the future. Presenters: Carla Dewberry, Sarah Carlins, Cheryl Choice

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 safety and support, patient service delivery, data streams for situational awareness, facility practices, and communication plans. Presenters: Leann Walsh Download Presentation Materials

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 population in order to prevent unnecessary patient-provider contact and help combat the spread of COVID-19. The presenters discuss the scope and intended outcome of these efforts, as well as how these changes in access to telehealth services might continue going forward. 

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 Medicare Shared Savings Program (MSSP), as well as additional considerations for commercial value-based arrangements.

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. Presenters: Richard Church, Victoria Hamscho Download Presentation Materials  

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 presenters address the Stark Law compliance waivers issued by the Secretary of the Department of Health and Human Services related to the COVID-19 outbreak, and discuss the effect of a Self-Referral Disclosure Protocol submission in the context of CMS’ recently announced expansion of its Accelerated and Advanced Payment Program for various types of providers. Download Presentation Materials

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 as some important regulatory actions aimed at protecting the public health. Presenters: Kenneth Kennedy Download Presentation Materials