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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Advancing Primary Care in Washington, DC, in 2021

Guest post by Mara McDermott, Vice President at McDermott+Consulting.

With the 2020 election almost in the rearview mirror, clinicians and policymakers alike are turning their attention to the 2021 agenda. For primary care providers, 2021 will hopefully bring COVID-19 recovery and response efforts, additional opportunities to pursue value-based payment arrangements, and ongoing deployment of telehealth and virtual technology.

The 2020 presidential election is expected to bring about a change in administration. However, the “blue wave” Democratic sweep projected by some pundits and pollsters failed to materialize. Instead, in Washington, DC, we will have a closely divided US Senate, with the final balance of power to be determined by two run-off races in Georgia. The US House of Representatives will remain in Democratic control, but by a smaller margin. The narrow margins in the House and Senate will likely constrain the extent to which Democrats are able to advance progressive policy changes. Instead, both sides of the political aisle in Congress are likely to focus on bipartisan areas of agreement. For primary care clinicians, this environment may be encouraging, as members of both parties share goals around protecting and advancing primary care across the country.

COVID-19 Response

When the new Congress begins and President-Elect Biden is inaugurated in January 2021, COVID-19 relief is expected to be at the top of the agenda. Expect President-elect Biden and the incoming Congress to pursue economic and public health relief. Clinicians across the country who have faced depressed revenue as [...]

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After the Curve Podcast: Focus on Health Insurance and Coverage

COVID-19 has catalyzed significant changes in the patterns of healthcare delivery, with the potential for long lasting effects on payors as a result. On this episode of the After the Curve podcast, we discuss how the COVID-19 pandemic may shift the healthcare coverage and payment landscape as well as how it may boost integration among payors and providers. McDermott’s Chief Marketing Officer Leslie Tullio is joined by Kate McDonald and Ankur Goel to discuss relevant topics for both payers and the healthcare industry more broadly, including:

  • How COVID-19 is changing healthcare utilization patterns in the US and the impact of that disruption on insurers
  • The reaction from health plans to the financial impact of COVID-19 on providers
  • The impact of telehealth and regulatory waivers at the state and federal levels on the payor market
  • Top lessons that payors have learned from the pandemic and subsequent next steps
  • Opportunities for healthcare leaders to synthesize where we are today
  • Key takeaways for payors moving forward from the pandemic

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Regulating Medical Devices Post Brexit

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in England, Wales and Scotland after the BREXIT transition period (different rules will apply to Northern Ireland). This On the Subject outlines key dates for implementation of the new rules and certain practical implications of changed regime.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance (the Guidance) on new rules that will govern the regulation of medical devices after the end of the transition period. Whilst some of this guidance is similar to guidance issued as part of the “No deal BREXIT” publications in 2019, the MHRA has also set out proposals to engage and consult on a new medicines and medical devices regulatory framework for the UK.

The UK left the European Union (EU) in January 2020 but is currently in a transition period. The Guidance was released as part of a collection of updates covering various MHRA-regulated sectors (including medicines, clinical trials and licencing procedures) which will also be subject to new rules from 1 January 2021.

This update focuses on the new regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) placed on the market in England, Wales and Scotland (Great Britain) only. Different rules will apply to Northern Ireland.

Existing law to continue
The rules that currently regulate medical [...]

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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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European Healthcare Innovation & Investment in a Post-Pandemic World

As part of McDermott’s HPE Europe 2020: Where Do the Opportunities Exist for Investment in the Healthcare Sector? webinar, McDermott London Managing Partner Hamid Yunis moderated a panel of industry experts including; Dr. Michelle Tempest of Candesic, Dr. Joanne Hackett of IZY Capital, Dr. Charles Niehaus and Professor Karol Sikora of Rutherford Cancer Centres, who collectively shared their perspectives on healthcare innovation and investment in a post-pandemic world.

The panelists agreed that COVID-19 has served as a catalyst for change and which has revealed important prospects for the future.

“There has been this zest for change which we’ve been talking about for a long period of time, and this has finally been that breakthrough,” said Dr. Tempest. “Both the professionals and the consumers have suddenly woken up to this new dawn.”

“What I’ve actually seen in the past couple of months is a lot of innovation that we were really wanting to accelerate are now actually happening,” agreed Dr. Hackett. “And it’s because we’re finally able to look to the future and think about future proofing to make sure that our healthcare system is actually going to deliver. I see positivity.”

Dr. Niehaus emphasized that, the real opportunity at the moment is to take the technologies many people were resistant to pre-COVID now acceptable, and use the shift as a “springboard to actually move forward.”

“We struggle with the cumbersome nature of a nationalized system that doesn’t really encourage entrepreneurism,” Professor Sikora cautioned. “The entrepreneurial skills are there — in [...]

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Coronavirus Resource Center | Preparedness Planning for Businesses

In our global economy, Coronavirus (COVID-19) raises serious concerns for employers in all industries. Workers may be on the front lines caring for patients and developing vaccines, travelling for business, or in close contact with individuals who travel or may have been affected. At this time, there is no vaccine or medication approved to prevent or treat the COVID-19 disease. Therefore, preparedness and prevention are crucial. Frontline responders must be especially vigilant as they deliver care and anticipate the challenges this uncharted territory presents.

McDermott’s Coronavirus Resource Center, brought to you by a multi-disciplinary team, will keep you informed of the latest developments and provide comprehensive insight to help you navigate this crisis with your employees, including:

  • Frequently asked questions for US and multi-national employers
  • Recent news updates
  • Podcasts
  • Upcoming events

Click here to access the Resource Center.




Disrupting Healthcare – Constructively: Considerations for Executing Innovation

The healthcare industry is facing significant disruption from new market entrants and technology innovations that have the potential to improve how care is delivered, to lower healthcare costs, and to improve healthcare outcomes. But not all disruption is built to have a sustained and positive impact—how do you tell which innovative technologies and ventures will change healthcare for the better, and which are just noise?

We all hear about disruptive innovation – the power of innovative thinking that sees beyond traditional ways of doing things in favor of new, better methods. When innovators enter the health arena and consider its problems creatively, they seek to break down inefficient aspects that don’t work well for stakeholders and patients. Problems can arise, however, if these innovators simultaneously disrupt processes or protective expectations that serve important functions. Healthcare is a heavily regulated and normative environment—for good reason. Many of its laws and norms function to keep patients safe and clarify roles and responsibilities. This post explores key considerations for new entrants into the healthcare marketplace.

Know Your Audience

To help ensure that disruption is constructive, make sure you understand the needs of your customers and their obligations to their customers and internal stakeholders. Because hospitals, health plans and providers, for example, must operate within a complex regulatory environment, your product or service needs to take those constraints into account. No matter how powerful your technology is, if it shifts regulatory burden onto your customers’ shoulders, it risks being unadoptable.

Data privacy presents a [...]

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How to Engage in Constructive Disruption

The healthcare industry is facing significant disruption from new market entrants and technology innovations that have the potential to improve how healthcare is delivered. But how do you tell which innovative technologies and ventures will have a sustained and positive impact, and which are just noise? In this episode of the Collaborative Transformation podcast series, Lucia Savage, chief privacy and regulatory officer at Omada Health, joins McDermott partner Jennifer S. Geetter to discuss:

  • What it takes for disruption to be truly constructive in today’s dynamic market
  • The rise of mobile healthcare delivery and patient engagement, driven by technological advances and consumer expectations
  • The limits of the HIPAA regulatory framework and current reimbursement rules as they relate to digital health technologies
  • Tips for tapping into the growing digital health innovation community through strategic investment

Click here to listen to the episode.

 




Five Questions with a Health Lawyer: Marshall E. Jackson, Jr.

Marshall E. Jackson, Jr.
Associate
Office: Washington, DC
Year at Firm: 4

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

My favorite part of practicing healthcare law at McDermott is working with clients that are out in front tackling very interesting and unique issues. The healthcare industry continues to evolve, and our clients are at the forefront. The changes in the industry have required clients to navigate areas of uncertainty, and our clients look to us to help them navigate that uncertainty. I have been blessed to sit shoulder to shoulder with a dynamic McDermott team helping our clients tackle new and unprecedented issues. No day is a dull day.

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

Many of our clients face the challenge of balancing the need to deliver affordable, quality healthcare to people when and where they need it, while maximizing return on investment for their business within a hot healthcare market. While one side seems provider-centered and the other investor-centered, providers and investors alike grapple with this balancing act. In addressing this balance in the context of an ever-changing industry, our clients are seizing opportunities to embrace new ways to deliver healthcare, and forming strategic partnerships and collaborations to strike the balance. We are increasingly seeing [...]

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Proactive Due Diligence Considerations for Life Sciences Dealmakers

In today’s competitive and fast-paced life sciences dealmaking environment, buyers and investors are often unable to spend as much time on due diligence as they might like. Market players are often highly focused on the science itself and, as a result, may pay less attention to issues such as supply chain, intellectual property components and reimbursement. However, addressing these topics at the due diligence stage is critical—they can cause a deal to unravel if left unexamined, regardless of the strength of the science.

Due diligence standards and considerations vary significantly across life sciences subsectors— pharma, medical devices, digital health and AI are each governed by unique regulatory structures and operate in very different deal landscapes. Buyers and investors are well advised to consider end-game issues such as reimbursement options, protection for valuable IP and pathways to commercialization early in the planning process. Framing the areas of diligence focus around the value drivers of their target deal model and key contract elements requiring verification will allow buyers to leverage their diligence findings into an informed, forward-thinking action plan.

Reimbursement. When evaluating a potential life sciences transaction, it is never too early to start thinking about reimbursement. Due diligence should take into account the commercialization channel for the product and include engagement with data sources on alternative therapies and their reimbursement. If the product in view is entering an existing market, conversations with reimbursement specialists can help a buyer determine the best path to reimbursement. A product that is opening a new [...]

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