K&l Gates Health Care Triage

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. Presenters: Hannah Maroney, Cheryl Choice, and Steven Pine Download Presentation Materials

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 highlights the implications of this decision, including how it may prevent future ERISA preemption of similar claims related to payment for out-of-network services. Presenters: Gary Qualls Presentation Materials

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 particular, Mr. Cooper discusses the ways in which the Allina decision and the CMS memorandum may limit CMS’ ability to cite certain regulatory guidance as a basis for enforcement actions. Presenters: Adam Cooper Download Presentation Materials

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 the role EKRA may play when structuring CIN arrangements. Presenters: Limo Cherian, Carla DewBerry, Steve Pine Download Presentation Materials

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 coming year, and an opportunity for stakeholders to engage with the federal government on matters of health IT. Presenter: Ryan Severson Download Presentation Materials

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 strategies. However, it contains some recommendations that could greatly impact covered entities, such as using state plan amendments to limit the ability of some or all covered entities and/or contract pharmacies to use 340B drugs for Medicaid beneficiaries. As states implement these strategies, operational and compliance challenges may arise for covered entities, particularly for those that are filling prescriptions for Medicaid beneficiaries in multiple states with potentially differing requirements for identifying duplicate discounts. Presenters: Macy Flinchum, Victoria Hamscho Download Presentation Materials

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 overall trends in the business of health care.  Presenters: Lindsey Rogers-Seitz Download Presentation Materials

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. Presenters: Ryan Severson, Victoria Hamscho Download Presentation Materials

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 guidance from the Centers for Medicare & Medicaid Services (CMS) related to this change and how CMS intends to recognize these units moving forward. Presenters: Darlene Davis Download Presentation Materials

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 changes to applicable reporting requirements. Presenters: Steven G. Pine Download Presentation Materials

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, Gina Bertolini and Steve Pine discuss SAMHSA’s recent proposed rule that seeks to modernize Part 2 by aligning the regulations with recent advances in the delivery of health care, while retaining important privacy protections for individuals with substance use disorders (SUDs). For additional information related to this episode of Triage, please see our accompanying client alert. Presenters: Gina L. Bertolini and Steven G. Pine Download Presentation Materials

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. 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, Gina Bertolini provides some background on the Part 2 regulations themselves and how the opioid epidemic has affected their enforcement. Ms. Bertolini also touches on recent efforts by Congress and SAMSHA to modernize Part 2 in response to stakeholder input. Presenters: Gina L. Bertolini Download Presentation Materials

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 episode, Ms. Barger discusses several additional key Merit-Based Incentive Payment System (MIPS) proposals presented in the proposed rule, including those related to the weighting of performance categories and updates to MIPS performance thresholds. Presenters: Kathy G. Barger Download Presentation Materials

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.  Ms. Cherian presents an overview of the QPP and discusses CMS’ newly proposed framework for Merit-based Incentive Payment System (MIPS) participation, the MIPS Value Pathways. Presenters: Limo T. Cherian Download Presentation Materials

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. Their discussion covers a number of issues, including the development of an effective intellectual property policy, intellectual property assignments, dealing with start-ups, ownership issues with respect to inventions developed in collaboration with other institutions, and the rights requirements for patent enforcement. Presenters: George C. Summerfield and Kelly A. Plummer, Ph.D. Download Presentation Materials

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. Presenters: Richard Church and Ryan Severson Download Presentation Materials

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. Presenters: Richard Church and Ryan Severson Download Presentation Materials

*UPDATE* Since initial publication of this episode, CMS has delayed implementation of this policy until April 2020. The Centers for Medicare and Medicaid Services (CMS), recently announced that it plans to activate systematic validation edits for Outpatient Prospective Payment System (OPPS) providers with multiple service locations that will verify whether the address listed on each claim matches the address in CMS’ Provider Enrollment, Chain and Ownership System (PECOS) database. In this episode, Gabe Scott provides some background on why CMS is making this change, why it is important, and what providers with off-campus provider-based locations might do to address this issue. Presenters: Gabriel Scott Download Presentation Materials

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. This episode discusses the issues raised by an unconventional provider of surgical equipment and staff necessary for in-office outpatient surgeries related to the denial of separate claims it submitted under out-of-network ERISA plans. This episode also outlines the analysis of the court as well as key takeaways, particularly including the importance of plan language for interpretation of ERISA plans. Presenters: Gary S. Qualls and Zachary W. Ernst Download Presentation Materials