Larry Guess
Partner
Office: Chicago
Years at the Firm: 6 years

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

My favorite part of practicing healthcare law at McDermott is the complexity of our client matters and working with my colleagues to get great results for our clients. The healthcare industry is constantly changing and innovating, and our clients engage us to help them adapt to these changes and maximize innovation in the space.

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

The biggest opportunity facing our clients is the bullish investment perspective in the healthcare industry. Currently, there are buyers with a tremendous amount of capital to deploy and sellers looking to maximize current market conditions. The healthcare transactional climate is very dynamic and certain clients are willing to invest in more risky assets. While the payoff can be substantial, the speed and complexity of these transactions can be very challenging for clients.  McDermott’s healthcare group excels in delivering value to our clients by managing the speed of transactions while navigating complex regulatory regimes, enabling our clients to understand the risk associated with a particular investment and opportunities to maximize returns.

What kind of client work gets you most excited when it comes across your desk? 

Continue Reading Five Questions with a Health Lawyer: Larry Guess

2019 was a robust year for the US Food and Drug Administration’s (FDA’s) regulatory agenda. The agency continued to implement initiatives and mandates required by the 21st Century Cures Act (Cures Act), and navigated leadership and staffing changes at many levels. Most notably, Commissioner Scott Gottlieb resigned on April 5. Norman Sharpless and Brett Giroir served as acting interim commissioners following Commissioner Gottlieb’s resignation. On December 17, Congress swore in Commissioner Stephen Hahn, a radiation oncologist and former chief executive of MD Anderson Cancer Center.

This Special Report reviews notable actions that shaped FDA-regulated industries and products last year, and offers insight into the agency’s 2020 priorities and expected actions in a number of areas, including:

  • Digital health;
  • Streamlined product approvals;
  • Evolving evidentiary thresholds for product approvals;
  • Strategic enforcement;
  • And much more.

Click here to read the full report. 

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 common pitfall for healthcare disruptors in this regard. A new technology might accomplish a task better or faster than traditional methods, but involve data aggregation and sharing pathways that pose steep compliance difficulties. If a healthcare innovation is difficult to implement, it compromises its value. Innovators should carefully evaluate the environment in which their disruptive technology will be deployed, and build measures into its architecture to meet all legal, normative and workflow requirements.

Map Out Your Path to Market

Innovators should also consider what it will take for their product to be ready to bring to market. For technologies that fall under US Food and Drug Administration (FDA) regulatory purview (such as medical devices), that agency will determine when the product has been demonstrated to be safe and effective. But for products not regulated by FDA (such as consumer wearables), market readiness is less clear cut.

In other industries, tech innovations often go through multiple iterations, with subsequent product launches implementing improvements upon the initial model. In healthcare, however, any design deficiencies can have serious safety and effectiveness consequences for the people who rely on your innovation. Even as healthcare innovators seek to disrupt the status quo, they should invest the time and resources necessary to thoroughly test and demonstrate their product’s safety and efficacy.

Finding a balance between agility and thoughtful attention to the realities of the health industry can be an adjustment for new market entrants, but with the right partners and a patient-focused approach, today’s innovators can make sure their disruption changes healthcare for the better.

For a deeper drive into these issues and more, listen the latest episode of McDermott’s Collaborative Transformation podcast.

Jeremy Earl
Partner
Office: Washington, DC
Years at the Firm: 10

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

My favorite part about practicing at McDermott is the challenging and constantly evolving nature of the work. Our clients put trust in us to advise them on their toughest legal questions and business challenges. I don’t take that trust lightly and it is exciting to come to work every day to meet and exceed the high expectations clients rightly have for us.

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

I represent managed care companies, which has traditionally meant health insurers and health maintenance organizations (HMOs). Due to legislative and competitive factors, healthcare financing and delivery is rapidly evolving and new models are being introduced to compete with traditional health insurers and HMOs. In 2012, Ezekiel Emanuel and Jeffrey Liebman boldly predicted in the New York Times that “[b]y 2020, the American health insurance industry will be extinct” and replaced by ACOs. That this has not happened is, at least in part, due to innovation by health insurers through such efforts as expanding value-based payment models.

At the same time, the traditional roles of providers and health insurers are blurring and providers and risk-bearing intermediaries are introducing innovative ways to finance healthcare delivery that compete with health insurers. While this has increased competitive pressures on managed care companies, I am excited to support companies who are driving this innovation.

What kind of client work gets you most excited when it comes across your desk? Continue Reading Five Questions with a Health Lawyer: Jeremy Earl

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.

 

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 the industry embrace the use of digital heath technologies to allow providers to reach patients and address growing healthcare concerns. We are also seeing providers, payors, retailers, tech companies, and investors collaborating in new ways to spearhead innovation within the industry. It has been great to work with clients to address this challenge through innovative approaches.

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

Healthcare is facing a time of transformation as regulators, providers and other stakeholders take action to improve care coordination and increase the use of technology to deliver care. Hospital and health system innovation centers are increasingly acting as the catalyst to fuel growth and expansion through technology and data. In this episode of the Collaborative Transformation podcast series, McDermott partners Kerrin Slattery and Krist Werling discuss:

  • Opportunities for innovation centers and other collaborative arrangements in healthcare
  • Top regulatory and compliance challenges innovators face and ways to navigate them
  • Organizational and cultural issues for healthcare leaders to consider when making innovation a strategic priority
  • Investment structures and unique due diligence concerns to address when designing or investing in innovative deals
  • Key considerations when executing cross-border transactions in healthcare and life sciences

Click here to listen to the full episode. 

Kerrin and Krist, alongside other McDermott partners and executives from some of healthcare’s most innovative organizations, will address more topics related to collaboration and industry innovation at McDermott’s Hospital & Health System Innovation Summit on October 24 in New York. Click here to learn more about this program. 

Name: James A. Cannatti III
Practice Focus Area: Healthcare Fraud & Abuse
Office: Washington, DC
Years at Firm: 1

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

My favorite part of working in the McDermott Health practice, and at the Firm generally, is the team approach to advising clients. Each of us has unique subject matter knowledge and experience in different areas of law. Very often, our clients require advice that cuts across multiple areas and issues. By working together across different disciplines within the Firm and within the Health practice we can provide comprehensive advice and counsel to our clients – not just advice on one discrete issue – and approach things from a broader, strategic perspective to help meet their needs.

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

I work in the healthcare regulatory space, focusing on federal and state fraud and abuse issues. As the healthcare industry has evolved and focused more on delivering value, many fraud and abuse laws, which were written decades ago, have not kept pace and have been seen as barriers to innovation. Over the last few years regulators have signaled a willingness to rethink how some of the laws should be applied to novel arrangements and approaches to care. The evolving regulatory landscape and the potential removal of some of the barriers posed by the fraud and abuse laws presents a significant opportunity for clients to pursue transformative approaches to care within our healthcare system. At the same time, change creates uncertainty and when there’s uncertainty there is also risk. Those who are able to manage the uncertainty and take advantage of new opportunities will be well positioned for success.

Continue Reading Five Questions with a Health Lawyer: James A. Cannatti III

In today’s highly competitive healthcare environment, investors may find themselves in an auction process where they must conduct due diligence pre-exclusivity. With limited time and mounting pressure, it can be difficult to know what issues to prioritize. Here are some practical tips for focusing your due diligence efforts strategically in a pre-exclusivity setting:

  • Quality of Earnings: Against the backdrop of high valuations, quality of earnings should be a key diligence focus, particularly in the context of high-complexity transactions  such as corporate carve-outs, partnerships with corporates and public-private pairings. For example, it is critical to examine the pro forma EBITDA to see if it excludes costs or includes questionable adjustments or add-backs.
  • Timeline: How competitive is the auction process and when are bids due? Does the buyer plan to conduct a full due diligence review pre-exclusivity, or instead look for big ticket liabilities that have a potential to impact valuation or derail the transaction?
  • Legal Showstoppers: Keep an eye out for legal showstoppers—issues that go to the core of the business, are not isolated incidents and are not fixable through purchase price adjustments, indemnification, escrow or enhanced compliance measures. For example, referral relationships that are based on illegal arrangements, systemic upcoding, quality of care issues, tenuous relationships with hospital partners, untenable and promised salary increases, a culture of non-compliance, or a retiring physician workforce without adequate succession planning.

As you plan your due diligence, keep in mind these additional factors that can inform how you structure your efforts:

Continue Reading Tips for Conducting Effective Due Diligence in an Auction Process

Nora Klein
Associate
Office: Chicago
Years at Firm: 2

What is an interesting fact about yourself that others may not know?

I played college golf at University of Illinois and in September 2019 I will be competing in the United States Women’s Mid-Amateur National Championship in Flagstaff Arizona. This will be the 33rd annually national championship for female golfers over 25 years old. The United States Golf Association runs 16 National Championships a year and to be able to play in one is every golfer’s dream. I feel so grateful to work at a place that quite literally supports me on and off the golf course.

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

The biggest challenge for our clients is also the biggest opportunity – how to grow in the revolutionary and highly profitable yet competitive life sciences industry, which is continuously expanding into new and often groundbreaking subsectors. Navigating these issues makes working at McDermott an enjoyable challenge. We not only need to assist our clients in finding innovative ways to grow their enterprises and remain compliant with healthcare rules and regulations, but also provide thoughtful, forward-looking solutions and plans that allow them to grow as these new subsectors emerge.

Continue Reading Five Questions with a Life Sciences Lawyer: Nora Klein