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.

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 the industry with many new opportunities to participate in novel compensation arrangements with providers.  However, these proposed changes come with a degree of uncertainty regarding what is in and out of bounds. That is to say, what type of value-based arrangements will squarely satisfy a Stark Law exception or AKS safe-harbor and which arrangements may subject a provider to material compliance risks? These types of questions often emerge with a shifting regulatory paradigm, and dually offer stakeholders with both risk and reward.

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

Continue Reading Five Questions with a Health Lawyer: Nicholas Alarif

Matt Perreault
Office: Boston
Years at Firm:  2

What is your favorite part about practicing health care law at McDermott? 

As so many of my colleagues have expressed throughout this series, my favorite part of practicing healthcare law at McDermott is being a member of a collaborative and collegial team that is advising our diverse clients on their most critical and pressing issues.  Having spent much of my career in-house, I have experienced firsthand how McDermott’s approach to client service, anchored in humility, empathy and practicality, consistently delivers differentiated value and results for our clients.

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

I believe that the transition to value-based arrangements will continue to accelerate. Collaborative Transformations will proliferate and present both tremendous opportunities for, and challenges to, traditional healthcare providers. Hospitals, health systems and other providers who embrace the challenges and opportunities presented by this paradigm shift will reap the benefits of their investments.  Those who resist this cultural change risk losing ground and market share to their competitors.

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

Continue Reading Five Questions with a Health Lawyer: Matt Perreault

Hospitals and health systems are facing consumer demand for innovation, the need to expand and enhance streams of revenue and the push for improved quality, all while navigating changing regulations, federal enforcement, antitrust litigation and business pressures. 2019 saw hospitals and health systems navigate these challenges and more, with valuable lessons for 2020.

This Special Report presents some of the key legal actions and trends impacting hospitals, health systems and investors in the space, along with insights on how these developments will impact organizations in 2020. We address, among other topics:

  • 2019’s transformative regulatory changes and legislation, and the legal challenges that followed
  • Financial distress signals, pricing strategies and contracting practices
  • Collaborative Transformation at work in a variety of sectors and the increase in innovation centers
  • Data privacy and cybersecurity challenges impacting the healthcare space

Click here to read the full report.

This blog was originally published on McDermott’s Antitrust Alert Blog.

On February 4, 2020, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) released joint guidance concerning competition for biologics, including biosimilars. The joint guidance seeks to enhance competition for biologics and reduce manufacturers’ use of false or misleading statements or promotional communications concerning the efficacy or safety of biosimilars and other biologics. This guidance appears to be part of the Trump administration’s effort to reduce the cost of medications for consumers, as it is aimed at increasing the level of competition biosimilars can offer and raising awareness of the safety and efficacy of biosimilars.

The fast-growing biologics market has become an important sector of the healthcare and pharmaceutical industry. According to the joint guidance, private insurers spent over $125 billion on biologics in 2018 alone. Biologics treat many serious conditions that often lack alternative treatment options. Although Congress enacted an abbreviated FDA-approval process for biosimilars nearly a decade ago, adoption of biosimilars has been relatively slow. The FTC and the FDA will focus on competition for biologics in hopes of improving patient access to important treatment options and curbing costs. The joint guidance highlights the agencies’ efforts to transfer recent investigatory and enforcement efforts to biologics markets.

The joint guidance sets forth goals for which the FTC and the FDA will agree to collaborate in their efforts to support adoption of biosimilars and enhance competition in biologics markets. These goals build on recent efforts by both agencies to deter anticompetitive conduct in the pharmaceutical industry more broadly. The joint goals include:

Continue Reading Anticompetitive Conduct in Biologics – An Enforcement Priority with FTC and FDA

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 use of data – these are the tools that will allow providers to improve outcomes and reduce costs of care.

From my perspective, the biggest challenge for healthcare provider clients (and those clients that invest in the healthcare services industry) will be continuing to manage the transition to value-based care. The cost of healthcare in the US has been, and will continue to be, a hot topic for political and economic discussion. The movement away from traditional fee-for-service reimbursement, and towards a model that is based on value and outcomes, is one about which all providers must be thinking carefully.

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

Continue Reading Five Questions with a Health Lawyer: Joe Parise

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