HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
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McDermott and EY at the 2022 J.P. Morgan Healthcare Conference: Hospitals and Health Systems Forum

A series of panels co-hosted by EY and McDermott Will & Emery during the 2022 J.P. Morgan Healthcare Conference examined how hospitals and health systems continue to weather the pandemic. Leaders from the health system perspective looked at heightened cost pressures, resource strains and demands for better technology experiences, as well as innovative and collaborative responses to challenges. Policy experts spoke to the needs of providers, the antitrust landscape, and what Congress and the Biden administration might try to accomplish in the year ahead.



Below are the top takeaways for McDermott and EY at the 2022 J.P. Morgan Healthcare Conference: Hospitals and Health System Forum

Download the PDF here.

LACKING LABOR
Speaking about the current state of the pandemic, H. Mallory Caldwell, US health leader at EY, reflected on the earlier days of the pandemic. At that time, the common sentiment among health system leaders was that the arrival of a vaccine would upend the trajectory of the virus. However, availability of the vaccine hasn’t fulfilled that expectation, and the effects of COVID case waves have been reflected in health systems, specifically with increases in deferred elective procedures. Still, health services are hovering around pre-pandemic levels. The major crisis health systems are confronting is staffing. Although healthcare generally builds in a 3% wage inflation, in light of the “great resignation,” Caldwell said it is costing hospitals and health systems three [...]

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McDermott and EY at the 2022 J.P. Morgan Healthcare Conference: Life Sciences Investment Forum

Despite offering one of the lowest total deal values on record, 2021 was an active M&A year. Due to the strong capital markets, a seller’s market continued, creating additional urgency for biopharma companies to accelerate their partnership agendas, especially to access new modalities that are likely to be the cornerstone of future growth. The past year also put the MedTech industry in a position of strength. With record levels of firepower, transformational M&A is still a possibility. Yet with soaring valuations in the sector and the ready availability of capital through booming VC, IPO and SPAC markets, MedTechs, too, need a creative approach to dealmaking strategy if they are to secure future growth.

During the Life Sciences Investment Forum, two panels addressed the above topics. First, biopharma leaders discussed the current state of innovation and how companies can use dealmaking to access new products and/or technologies in 2022. Then, M&A leaders from MedTech organizations and private equity firms shared insights and best practices for their 2022 plans.

M&A FirePower: BioPharma




M&A FirePower: MedTech




Below are the top takeaways for McDermott and EY at the 2022 J.P. Morgan Healthcare Conference: Life Sciences Investment Forum

Download the PDF here.

THE INNOVATION IMPERATIVE
The explosion in new therapeutic modalities like mRNA or cell therapy is [...]

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Five Reasons You Can’t Miss HPE New York 2021

McDermott’s signature HPE New York event is right around the corner on October 15, 2021. This year more than ever, it’s a must-attend for private equity investors, healthcare executives, lenders, consultants and leaders across the industry.

Here are the top five reasons you don’t want to miss this exclusive event:

  • To help you navigate the current market’s unprecedented deal volumes and stiff competition, we’ll equip you with the latest analysis of the hottest investment sectors and game-changing deal strategies.
  • We’ve gathered the best and brightest minds in healthcare private equity to share their real-world insights into today’s market and the trends shaping tomorrow’s opportunities. Click here to view our roster of elite speakers.
  • Early risers have an opportunity to start their day right with our bonus Big Bankers Breakfast Discussion, where leading investment bankers will examine the current state of play and the dealmaking outlook for 2022.
  • This premier event is ultra-convenient. In light of ongoing safety and logistics challenges posed by COVID-19, we’re simplifying matters by streaming this year’s event right to your personal computer or device.
  • Registration is complimentary. In response to those continued challenges around COVID-19, we’re happy to offer complimentary registration this year and hope many of you are able to join us for this timely slate of sessions.

We look forward to virtually welcoming you to HPE New York in just a couple weeks. Click here to register today.




340B in 2021: What Covered Entities and Their Partners Need to Know Now

Since March 2010, increased growth in the 340B Program has been accompanied by increased scrutiny from state and federal governments and conflicts between various 340B Program stakeholders. A transition in U.S. Department of Health & Human Services (HHS) and Health Resources & Services Administration (HRSA) leadership may lead to changes in 340B Program policy, but the ongoing conflicts, particularly around contract pharmacies, will not likely be resolved quickly.

In this webinar, we discussed the current issues affecting 340B Program stakeholders, the tools (and their limitations) that may be employed by stakeholders and government agencies to resolve those issues, and what covered entities can expect in future developments affecting the 340B Program.

  1. Covered entities will likely be unable to resolve contract pharmacy issues quickly through either the current litigation or the ADR panels. While there are a number of pending cases related to the 340B Program, litigation can be inherently slow process. The Administrative Dispute Resolution (ADR) Final Rule that was published in December 2020 was recently enjoined and additional injunctions may follow. While HHS appears to be moving forward with operationalizing the ADR process, the ADR Panel members who would hear the disputes remain under review by the Biden Administration. If and when the ADR panels are finally implemented, decisions of those panels may be litigated too.
  2. Covered entities should review and monitor their state Medicaid program’s billing requirements for 340B drugs. State Medicaid programs must have a mechanism to identify 340B drugs when required to exclude them from [...]

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McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health Systems: Legal and Financial Trends

Leading professionals Gary Burke (Partner, Forensics, EY), Sandy DiVarco, and Jennifer Geetter (Partners, McDermott Will & Emery), Mike J. India (Managing Director, EY-Parthenon) and Matthew Weiss, MD (EY-Parthenon Managing Director, Health care, Ernst & Young LLP) discussed critical legal, regulatory and financial trends facing hospitals and health systems with moderator, Charlie Buck (Partner, McDermott Will & Emery).

Below are the top takeaways for McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health System: Legal and Financial Trends, click here to access the full webinar.

Access the PDF here.

LONG TERM CHANGES TO REGULATORY RESTRICTIONS
Many regulatory requirements were relaxed in respond to the COVID-19 public health emergency. There has been much discussion regarding the extent to which these restrictions will “snap back” after the end of the public health emergency, because the public health emergency has highlighted the value of certain delivery models.
“I think there is going to be streamlining in some of these regulatory structures. So when we look at what’s going to be durable, hopefully we will see changes in the process that will make it easier for hospitals and other providers to respond and to remain on top of things,” said Sandy DiVarco, Partner, McDermott Will & Emery. [...]

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EU Parallel Trade Permit: Who Has Burden of Proof that Plant Protection Products and Biocides Are Identical?

On 15 December 2020, the French administrative court specified who bears the responsibility to prove that two plant protection products are deemed identical, even in their packaging boxes, in the context of submitting an extension of a parallel trade permit.

Gritche, a French cooperative company specialised in the wholesale of chemical products, has been entitled to a parallel trade permit since 13 December 2014. The permit allows it to import a wheat and barley fungicide called “Tipi” from the United Kingdom. On 27 June 2017, the company filed an application for an extension to the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) in order to be able to import Tipi from Hungary. The product to be imported under the name “Tipi” holds a marketing authorisation on the Hungarian market under the name “D.” granted to Syngenta AD. Gritche considered that this product D. (which would be imported from Hungary under the Tipi name) was identical to the fungicide D. that Syngenta France SAS is allowed to sell on the French market.

On 31 July 2018, the ANSES reached its conclusions regarding the extension request for Tipi’s trade permit. The ANSES estimated that the active ingredients found in the Hungarian product D. and the one authorised in France under the reference D. had the same origin, and that both products’ composition was identical. However, the ANSES stated that the information at its disposal did not make it possible to ascertain whether the packaging was identical. Thus, [...]

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McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health System CEO Panel: Strategic Business Priorities

Our panel included a discussion on what is ahead for 2021 and how the challenges of COVID-19 will lead to lasting changes for hospitals and health systems, with Lloyd Dean (CEO, CommonSpirit), Melinda Estes, MD (President and CEO, St. Luke’s Health System) and Jaewon Ryu, MD (President and CEO, Geisinger). These top healthcare leaders discussed the short- and long-term impact of COVID-19 on hospitals and health systems and their strategic business priorities in 2021 and beyond with moderator Kerrin Slattery (Partner, McDermott Will & Emery).

Below are the top takeaways for McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health System CEO Panel: Strategic Business Priorities, click here to access the full webinar.

Access the PDF here.

HOW 2020 PRIORITIES WILL SUSTAIN AND PROVE HELPFUL IN 2021 AND BEYOND
For hospitals and health systems, 2020 began and was primarily focused on issues like cost and payment models, Medicaid expansion and the wellbeing of clinical providers, including physicians, where statistics cite 40% are burned out. SinceCOVID-19, hospitals instantly pivoted to healing their communities and their staff, as well as rejuvenating the delivery system. “I was very pleased to chair a task force on COVID-19 pathways to recovery that produced a dynamic document that has [...]

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McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Digital Health Pioneers Forum

 

 

Top industry executives BJ Moore, Executive Vice President and Chief Information Officer, Providence St. Joseph Health; Dr. Ali Parsa, Chief Executive Officer, Babylon Health; and Lucia Savage, Chief Privacy and Regulatory Officer, Omada Health, discussed the evolving doctor-patient relationship and the digitized data and technology convergence with healthcare delivery and payment along with moderators Dale C. Van Demark, Partner, McDermott Will & Emery; Rachel S. Hall, Partner, Digital Health Leader, EY; Stephen W. Bernstein, Partner, McDermott Will & Emery; and Lisa Schmitz Mazur, Partner, McDermott Will & Emery. They also provided insight into 2021’s regulatory considerations affecting healthcare innovation and its solutions.

Below are the top takeaways for McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Digital Health Pioneers Forum, click here to access the full webinar.

Access the PDF here.

CARE OF THE FUTURE
We are only seeing the beginning of the decentralization of care through information technology; but that shift is how scalable solutions to our health care challenges will develop. “Care delivery at home, where we can send patients home and remotely monitor them—eventually that will evolve to things like wearables -IoT devices- that we may have in our clinical settings. We’re seeing the hospitals play such [...]

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