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 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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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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Hospital and Health System Innovation Summit: Lessons Learned: Diligence, Detours and Data, Oh My

Industry leaders shared first-hand lessons learned from their work on recent innovation related projects. We covered a range of case studies, highlighting lessons learned around mission alignment, conflicts of interest, diligence considerations, data ownership and de-identification, and strategies for protecting a minority investor.

Below are the top takeaways for Hospital and Health System Innovation Summit: Lessons Learned: Diligence, Detours and Data, Oh My, click here to access the full webinar.

Access the PDF here.

Mission Alignment
It is essential for a hospital and health systems to adopt a formal innovation strategic
plan that aligns with its overall strategic mission and vision and clearly articulates it
specific innovation goals and prioritizes focus areas. Hospital and health systems
pursue innovation initiatives largely to support the clinical mission and drive revenue
growth and diversification. “I think that alignment with the strategic mission of the
organization is key because that really drives and helps shape the culture of innovation
as an organization. We define innovation in terms of in three buckets, the research
based, hospital based and external or open innovation,” said Kolaleh Eskandanian,
Vice President and Chief Innovation Officer, Children’s National. “So research based
is the traditional model of a transfer, [...]

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Hospital and Health System Innovation Summit: Nuts And Bolts: How to Invest in Innovation

There has been increased interest by hospitals and health systems in creating innovation centers and making innovation center investments, which are helping to transform the healthcare landscape. As they enter this space, hospitals and health systems must first decide how to organize to capitalize on and commercialize innovation opportunities to get innovations into the routine of patient care.

Joined by leaders from Health Innovation Strategies and Winter Street Ventures/Commonwealth Care Alliance, we discussed the fundamental types of investment structures from the health system perspective, including types of vehicles used by health systems, tips for aligning investment priorities with the health system mission, and collaborations with third parties to accelerate innovation.

Below are the top takeaways for Hospital and Health System Innovation Summit: Nuts And Bolts: How to Invest in Innovation, click here to access the full webinar.

Access the PDF here.

There are many options for structuring an innovation center and there is no one-size-fits-all model.
Innovation centers are often custom-built around the organization’s needs and with the input hospitals and health systems receive from their clinicians, board, patients, and community. Determining what innovation model to pursue involves weighing the amount of financial risk the entity will take on, the complexity of the venture, and the expertise available to guide the center’s [...]

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What is the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe?

In the fourth installment of McDermott’s HPE Europe Summer Webinar Series 2020: What’s the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe? moderator and McDermott partner Dr. Stephan Rau and industry experts Karthic Jayaraman of TPG Capital, Max Müller of Bayer, Ben Faircloth of L.E.K. Consulting and Dr. Ulrich Wandschneider, former CEO of Asklepios AG, currently at Trilantic Capital Partners and Supervisory Board member of BioNTech SE, the Nasdaq-listed developer of COVID vaccine, headquartered in Germany, discussed the impact that COVID-19 and the government measures to address it have had on investments in healthcare and life sciences in Europe.

“I think it’s about as interesting a time as any in my last 20 years investing,” said Jayaraman. “People are beginning to focus a lot more on innovation, the speed of innovation and how innovation is brought to market. I think the question is, “How can we continue to reward innovation, both by simplifying the process by which it’s made possible and how we value it?”

“New developments in digital health have become more and more attractive as people have had faster access to care and governments have understood that some of their regulations needed to be adjusted,” added Müller.

Jayaraman agreed. “There has been an acceleration of the provision of care through telehealth services and any kind of remote administration of care. It’s probably been an acceleration of two-plus years collapsed into months. I also think we’re going to see some vigorous [...]

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Five Questions with a Health Lawyer: Nicholas Alarif

Nicholas Alarif
Office: Washington, DC
Years at Firm:  3

What is your favorite part about practicing healthcare law at McDermott? 

I hate to sound like a broken record, but the best part about practicing at McDermott is the innovative and collaborative culture. I have found that McDermott fosters a team-based approach to solving client issues. The opportunity to interact with experts in so many disciplines and sub-disciplines to achieve common goals for our clients has been fantastic. Further, I have found that my colleagues are open to new approaches to tackle client issues and are always happy to streamline internal processes. Innovation is not what you typically think of in a law firm environment, and McDermott’s embrace of change makes for an exciting and fun place to practice.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today? 

The biggest opportunity and greatest challenge may actually be the same—a shifting regulatory landscape. For instance, the Centers for Medicare and Medicaid Services and the Office of Inspector General recently published proposed revisions to the physician self-referral law (Stark Law) and the Anti-Kickback Statute (AKS) regulations, which, among other things, are attempting to foster transitions from fee-for-service medicine to value-based care. These proposed changes will potentially allow providers broader flexibility when engaging in financial relationships with a value-based goal. The proposed changes present [...]

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Five Questions with a Health Lawyer: Joe Parise

Joe Parise
Partner
Office: Boston
Years at Firm: 6

What is your favorite part about practicing healthcare law at McDermott? 

In short: the people. I have always had a cross-office practice, and as a result have been lucky enough to work with many different attorneys within the Health practice group. I am constantly impressed by the depth and breadth of experience that the group offers, as well as the creativity and thoughtful approach that our attorneys bring to tricky client issues. Being surrounded by talented attorneys (from the senior partner to the junior associate ranks) makes me want to “raise my game” and, I think, brings out the best in each of us.

In addition to the professional qualities, I am grateful for the fact that our attorneys bring a positive attitude each and every day, and create an enjoyable working environment. I have made some great personal connections over the years, and consider many of my colleagues to be good friends.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?

For the most part, I work with healthcare services providers and those that invest in such providers. I think the biggest opportunity for my clients relates to innovation in healthcare services delivery. Embracing new technologies (including those related to telehealth), optimizing the collection and [...]

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Modernizing FDA’s New Drugs Regulatory Program – Reviewing the Guidance Ecosystem and Implications for Life Sciences Companies

In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while reducing regulatory burden, as well as to increase efforts for critical research and increase the involvement of patients and their perspectives in research and the product development process. The Cures Act specifically provided the US Food and Drug Administration (FDA) authority to modernize product development and review, and create greater efficiencies and predictability in product development and review. In June 2018, in response to this congressional mandate and corresponding new authorities, as well as reauthorizations of FDA’s user fee agreements, FDA made a series of announcements for a proposal to modernize new drug development.

Highlights of FDA’s initial proposal included:

  • Focusing on recruiting talent across disciplines;
  • Building multidisciplinary teams for more efficient collaboration;
  • Prioritizing operational excellence through a single and consistent review process;
  • Improving knowledge management through enhancements to information technology and honed expertise within review divisions;
  • Emphasizing safety and risk-benefit analysis before and after approval; and
  • Incorporating the patient voice into product development.

As articulated by former FDA Commissioner Scott Gottlieb, “[a] principal aim of these proposed changes is to elevate the role of . . . scientists and medical officers to take on even more thought leadership in their fields.”  The agency contemplates implementing organizational and structural changes that make drug review divisions more therapeutically-focused [...]

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Collaborative Transformation: Shaping the Future of Health Care, Together

As the health care and life sciences fields experience ever-increasing levels of disruption, diverse entities across the industry are teaming up to embrace and foster innovation. These new pairings are shaping the future of health care, as organizations come together to tackle the industry’s most pressing issues with redoubled agility and pooled resources.

In an environment of change and uncertainty, this trend of Collaborative Transformation is yielding improved financial outcomes, increased operational efficiencies, and a fresh infusion of diverse talent and perspectives—all of which result in enhanced quality of care.

This is where the McDermott Health and Life Sciences team comes in. As a top-ranked US health law practice and a leader in life sciences with decades of experience advising the leading players in US and cross-border health and life sciences, we have the skill, market insight and ingenuity to partner with you wherever your innovation takes you. Whether you are forming innovative alliances across borders and industries, creating or implementing groundbreaking technologies and services, or restructuring investments to position your organization at the cutting edge of the market, our team can work alongside yours to achieve excellence.

Click here to learn more about McDermott Health, our recent work executing collaborative transformations on behalf of our clients and how we can help your organization form innovative business relationships.




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