K&L Gates Healthcare Triage

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. P...

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 whi...

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...

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...

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...

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 co...

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, dat...

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-prov...

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 addi...

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, V...

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...

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 pro...

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 disclosur...

In this week's episode, Gary Qualls discusses the recent Louisiana federal district court decision in Crescent City Surgical Centre vs. United Healthcare of Louisiana , in which the court found that an out-of-network provider's claim against a third party payer was not subject to preemption under the Employee Retirement Income Security Act (ERISA) and was properly heard in state court. Mr. Qualls...

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 par...

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.  The presenters discuss how EKRA differs from the Federal Anti-Kickback statute, recent criminal litigation, and th...

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"). Mr. Severson discusses several key aspects of the Strategic Plan, which offers both insight into the direction the ONC and other federal agencies may take with respect to health IT regulation in the co...

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. The guidance largely lays out existing duplicate discount prevention strate...

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. Among these issues, Ms. Rogers-Seitz discusses the potential impacts of the 2020 presidential campaign, the health care industry's continued struggle against the opioid crisis, shifts in major regulatory structures, and overa...

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 Sa...

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, Darlene Davis discusses the impact of new guidan...