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?


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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?


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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 to promote efficient review and transparency in – as well as patient and stakeholder access to – the review process. According to the agency, these and other changes that are part of the Cures Act will result in a 20 percent improvement in efficiency.


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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