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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This Week in 340B: January 31 – February 6, 2023

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.

Issues at Stake: Medicare Payment; Contract Pharmacy
Where Things Stand:

  • In three Medicare payment cut cases, the district court judge has signaled her inclination to transfer the cases to the judge handling most other Medicare payment cut cases, and has asked for the parties to enter any objections to a transfer.
  • In one contract pharmacy case, the parties requested a stay pending the D.C. Circuit Court’s ultimate decision in Novartis Pharmaceuticals Corp. v. Johnson and United Therapeutics Corp. v. Johnson.
  • The drug manufacturer party in a contract pharmacy-related antitrust case filed a letter with the court to advise it of the Third Circuit Court of Appeals’ recent decision in Sanofi Aventis v. HHS and ask that it reach the same decision.
  • In the contract pharmacy-related antitrust case, the drug manufacturer parties filed a notice of supplemental authority with the court citing the Third Circuit Court of Appeals’ recent decision in Sanofi Aventis v. HHS in support of their motion opposing the plaintiff’s motion to amended their complaint.

Get more details on these 340B cases with the 340B Litigation Tracker, a subscription product from McDermott+Consulting.




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5 Questions with a Health Lawyer: Sharon Lamb

Sharon Lamb
Practice Focus Area: Health and Life Sciences
Office: London
Years at Firm: 4

What is your favorite part about practicing health and life sciences law at McDermott?
This is an easy question to answer! McDermott has a truly international health and life sciences practice with talented lawyers with deep expertise across all disciplines around the world– our lawyers truly works together as an integrated team and share a collective enthusiasm and energy for advising our international clients in a way that helps them move their businesses forward. I feel really privileged to work with such dedicated and talented lawyers. Our practice is both regulatory and transactional, meaning we support our clients on cross border investments and acquisitions to expand their businesses but also on strategic and regulatory issues, such as licensing, collaborations, and market access. The pandemic has been challenging on many levels – working remotely has been just one part of that. But, on the other hand, the move to virtual meetings and ease of zoom calling has created even more cohesion across our international offices.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
Our health and life sciences clients have been at the forefront of the fight against Covid-19 – whether that be providing care to patients or developing drugs and devices such as vaccines, and diagnostics. Many [...]

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5 Questions with a Health Lawyer: Dr. Deniz Tschammler

Dr. Deniz Tschammler 
Practice Focus Area: Health and Life Sciences
Office: Munich/Frankfurt
Years at Firm: 2

What is your favorite part about practicing healthcare law at McDermott?
Apart from exciting clients and projects, a great privilege of my work at McDermott is to closely collaborate with a wide range of inspiring and outstanding health and life sciences lawyers – in our German offices, across Europe and the US. I am regularly working on large collaboration, market entry or compliance projects that involve multiple jurisdictions and/or require different legal perspectives. In such projects, it is invaluable to be surrounded by the right team of experts. After more than two years at McDermott, I am still impressed to see how quickly you find such helpful team across all offices. Moreover, everyone shares the same attitude and passion for achieving our clients’ goals. It is magnificent to be a part of this.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
For many clients, the answer is digitization. At great speed, digitization is turning the health markets upside down. Digital health has started to revolutionize research and development, create entirely new ways of diagnosing and treating diseases, make the patient’s trip to the doctor or pharmacy unnecessary, and facilitate communication among all public and private players in the various health markets. This not only results in abolition and liberalization of outdated legal regimes, but also in new [...]

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5 Questions with a Health Lawyer: Brian Hall

Brian Hall
Practice Focus Area: Healthcare Transactions & Regulatory
Office: Washington, DC
Years at Firm: 3+ years

What is your favorite part about practicing healthcare law at McDermott?
It’s easily the colleagues I work with on daily basis. I’m fortunate that my practice requires me to work with attorneys across the entire Healthcare practice group and other practices at the Firm. Having colleagues who are the best at what they do is a tremendous resource for myself and our clients. I also really enjoy working on the cutting-edge legal issues our clients bring to us. Healthcare law is never static and forces us to always be learning to help clients navigate this increasingly complex legal landscape.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
My practice is focused primarily on healthcare transactions/M&A and related regulatory issues, representing investors like private equity funds and the healthcare providers they partner with. The healthcare delivery market continues to be highly fragmented with many specialty areas attractive to potential investors. This benefits healthcare providers who are facing increasing reimbursement and cost pressures while needing to invest heavily in technology to take advantage of telehealth modalities and value-based care arrangements. One of the greatest challenges facing investor clients today is the growing competition they face from other investors as the healthcare delivery space continues [...]

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5 Questions with a Health Lawyer: Caroline Reigart

Caroline Reigart
Practice Focus Area: Fraud & Abuse and Reimbursement
Office: Washington, DC
Years at Firm: 2.5

What is your favorite part about practicing healthcare law at McDermott?
McDermott is fortunate to be on the cutting edge of many of the legal issues that shape the healthcare industry. My favorite part of practicing healthcare law at McDermott is collaborating with and learning from my colleagues as we tackle novel and challenging problems. The McDermott health team is known for its collaborative approach and I love being able to discuss potential approaches and strategies with my colleagues. I am constantly learning from my attorney and professional colleagues and solving obstacles with my colleagues for clients makes the workdays pass quickly.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
Telehealth and digital health have been around for a while now, but with COVID-19 the widespread adoption of these technologies has presented huge opportunities but also significant challenges for our clients. In response to the pandemic, there are new opportunities for reimbursement for services and products provided remotely. However, the legal issues presented by these new technologies and partnerships that providers and innovators are seeking to offer are complex and require a thoughtful approach. Payment policies and guidance have also been evolving quickly, which makes staying on top of the changes difficult for clients.

What kind [...]

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McDermott and EY at the 2022 J.P. Morgan Healthcare Conference: European Healthcare Private Equity Forum

With continued growth in healthcare global investing, what role do European markets play in global and US fund portfolios and to what extent do investments benefit from a transatlantic portfolio? Sharon Lamb, Partner at McDermott, was joined by Marco Bonaiti, Vice President at Apax Partners; Tony Drabble, Partner at EY-Parthenon; Henry Elphick, Deputy Chair of the European Healthcare Private Equity Association (EHCPEA); Rohin Jain, Managing Director of H.I.G. Capital, and Dr. Stephan Rau, Partner at McDermott, to discuss the wide range of opportunities, benefits, similarities and differences in dealmaking in competitive global markets.



Below are the top takeaways for McDermott and EY at the 2022 J.P. Morgan Healthcare Conference: European Healthcare Private Equity Forum

Download the PDF here.

A FANTASTIC TIME FOR HEALTHCARE
Healthcare proved once again to be a resilient and innovative asset during the pandemic. Multiple new buyers are emerging, and they are making significant investments and large transactions across all sectors. The year ahead promises to be an active one with no signs of slowing down.

EUROPE IS INCREASINGLY ATTRACTIVE
Beyond the fact that the healthcare market in Europe is roughly a $2 trillion market, there are advantages to having a global portfolio. One of the big attractions of the European market is that it’s not just one market. Across countries and regions, the systems and stages of development are different; [...]

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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: Acceleration Capital

Digital health has never been hotter, and investor interest is surging across all stages. From early- to late-stage investments, lines are blurring with increased disruption in the digital health landscape. Traditional private equity and growth investors are moving earlier in the cycle in an attempt to capture the next unicorn, and venture capital investors are doubling down on their own portfolio. In this forum, private equity and venture capital leaders reviewed the state of the market and shared their approaches to investing in 2022 and beyond.




Below are the top takeaways for McDermott Will & Emery and EY at the 2022 J.P. Morgan Healthcare Conference: Acceleration Capital

Download the PDF here.

According to statistics from Rock Health, 2021 was the largest funding year for digital health to date, with $29.1 billion raised across 729 deals. Not only did 2021 see a record number of digital health deals, but the deals were larger than ever before: The average deal size in 2021 was $39.9 million, and the number of deals worth more than $100 million doubled from 2020 to 2021. In 2021, the six
top-funded value propositions were research and development, on-demand healthcare, treatment of
disease, fitness and wellness, healthcare marketplace and nonclinical workflow. The six top-funded
clinical indications were mental health, diabetes, cardiovascular, primary care, musculoskeletal and
oncology.

Two key trends are driving this massive influx of [...]

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McDermott and EY at the 2022 J.P. Morgan Healthcare Conference: Healthcare Private Equity Leaders Forum

During this session, leading private equity investors explored key drivers and trends across diverse industry subsectors. They examined how shifting regulations and the upcoming 2022 midterm elections may alter the deal landscape and mapped out strategies for adapting and thriving amid change. Panelists also offered their exclusive insights into emerging opportunities in health information technology (IT) and forecasted the next evolution of today’s hypercompetitive market.



Below are the top takeaways for McDermott and EY at the 2022 J.P. Morgan Healthcare Conference: Healthcare Private Equity Leaders Forum

Download the PDF here.

From a macroeconomic perspective, the US healthcare market has seen growth through the COVID-19 crisis because of unprecedented government intervention, a significant rebound in consumer spending (although with pockets of softness) and an outlook for historically high nominal growth as COVID-19’s impact recedes but price inflation takes center stage. Although healthcare spending and employment levels have largely returned to pre-pandemic levels, the spread of the Omicron variant poses a threat to this stability, and the labor supply faces serious challenges. Workforce shortages have yielded significantly higher rates of labor cost growth—particularly in post-acute care—helping to drive healthcare inflation. While rising inflation will not necessarily inhibit healthcare deal activity, if corporate interest rates increase, healthcare investments could be affected.

In this current economic environment, investors are paying attention to entities and innovations with the potential to relieve constraints on the healthcare system. Prominent [...]

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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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