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

5 Questions with a Health Lawyer: Sandra M. DiVarco

Sandra M. DiVarco
Practice Focus Area: Health
Office: Chicago
Years at Firm: 19 years

What is your favorite part about practicing healthcare law at McDermott?
I sometimes joke that there is “never a dull moment” in my practice, but it really isn’t a joke! With the spectrum of clients we serve in the healthcare space, we are faced daily with novel questions, complex situations and unique business issues – often with incredibly short timelines. Even after years of practice, no two days are exactly the same and I would not have it any other way.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
My practice is primarily focused on assisting hospitals and healthcare systems with the diversity of regulatory and corporate issues they face every day. Even before the COVID-19 pandemic, adapting to the changing nature of healthcare was posing challenges for these providers. The pandemic accelerated the use of what were previously novel care delivery processes, fueled by regulatory flexibilities permitted during the public health emergency. How hospitals and health systems will further adapt by scaling back (in cases where flexibilities are not made permanent) or ramping up (where regulatory changes are made permanent) will be the next challenge. Revenue hits from the pandemic and provider burnout may dampen some of the energy for major change as we emerge from [...]

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5 Questions with a Health Lawyer: Esther Chang Weese

Esther Chang Weese
Practice Focus Area: Health
Office: Los Angeles
Years at Firm: 18 years

What is your favorite part about practicing healthcare law at McDermott?
Hands down – the people. I started at McDermott as a summer associate in 2002, and I tell potential recruits all the time that there is no other big law firm that I would rather practice at because of the team we’ve built at McDermott – the quality and the character of the people here are bar none. I also enjoy that I am still learning and being challenged, because at McDermott, we are advising clients who are on the cutting edge of innovation and change in the healthcare industry.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
Two thoughts on this: first, the pandemic accelerated the use of digital tools and we’re seeing some of our clients trying to figure out how to more effectively implement virtual care, get paid for it and grow their telehealth networks. Second, while we have seen continued physician group mergers and acquisitions, we are also seeing some pushback on these consolidation efforts by regulators. For example, here in California, Assembly Bill 1132 (initially introduced in February 2021) would have required California Attorney General review of certain healthcare provider transactions (including transactions involving medical groups) with a value of three [...]

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5 Questions with a Health Lawyer: Gregory E. Fosheim

Gregory Fosheim, JD, MPH
Practice Focus Area: Healthcare and Life Sciences
Office: Chicago, IL
Time at Firm: 2.5 years

What is your favorite part about practicing healthcare and/or life sciences law at McDermott?
There’s a reason why everyone answers this question with “the people.” The cadre of attorney and business professionals I have the privilege of working with every day is truly extraordinary, each of whom is exceedingly generous with their time and support, despite overwhelming workloads themselves. Everyone understands the healthcare and life sciences landscape and has an unapologetic passion toward doing impeccable work with the utmost professionalism and a healthy dose of humor and humility. It felt like I was given a parachute on my first day that allowed me to take leaps of faith to expand my practice into new areas of focus with the reassurance of a soft landing if I had any questions or challenges. Everyone is an integral member of the team and it shows.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
We have an exhausted industry caring for an exhausted nation. The challenges today are the same challenges that the American healthcare system has had for decades: How to innovate? How to differentiate? How to collaborate? Now that we are more than a year into the global COVID-19 pandemic, [...]

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340B in 2021: What Covered Entities and Their Partners Need to Know Now

Since March 2010, increased growth in the 340B Program has been accompanied by increased scrutiny from state and federal governments and conflicts between various 340B Program stakeholders. A transition in U.S. Department of Health & Human Services (HHS) and Health Resources & Services Administration (HRSA) leadership may lead to changes in 340B Program policy, but the ongoing conflicts, particularly around contract pharmacies, will not likely be resolved quickly.

In this webinar, we discussed the current issues affecting 340B Program stakeholders, the tools (and their limitations) that may be employed by stakeholders and government agencies to resolve those issues, and what covered entities can expect in future developments affecting the 340B Program.

  1. Covered entities will likely be unable to resolve contract pharmacy issues quickly through either the current litigation or the ADR panels. While there are a number of pending cases related to the 340B Program, litigation can be inherently slow process. The Administrative Dispute Resolution (ADR) Final Rule that was published in December 2020 was recently enjoined and additional injunctions may follow. While HHS appears to be moving forward with operationalizing the ADR process, the ADR Panel members who would hear the disputes remain under review by the Biden Administration. If and when the ADR panels are finally implemented, decisions of those panels may be litigated too.
  2. Covered entities should review and monitor their state Medicaid program’s billing requirements for 340B drugs. State Medicaid programs must have a mechanism to identify 340B drugs when required to exclude them from [...]

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