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.
- 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.
- 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 [...]
McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health Systems: Legal and Financial Trends
Leading professionals Gary Burke (Partner, Forensics, EY), Sandy DiVarco, and Jennifer Geetter (Partners, McDermott Will & Emery), Mike J. India (Managing Director, EY-Parthenon) and Matthew Weiss, MD (EY-Parthenon Managing Director, Health care, Ernst & Young LLP) discussed critical legal, regulatory and financial trends facing hospitals and health systems with moderator, Charlie Buck (Partner, McDermott Will & Emery).
Below are the top takeaways for McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health System: Legal and Financial Trends, click here to access the full webinar.
Access the PDF here.
LONG TERM CHANGES TO REGULATORY RESTRICTIONS
Many regulatory requirements were relaxed in respond to the COVID-19 public health emergency. There has been much discussion regarding the extent to which these restrictions will “snap back” after the end of the public health emergency, because the public health emergency has highlighted the value of certain delivery models.
“I think there is going to be streamlining in some of these regulatory structures. So when we look at what’s going to be durable, hopefully we will see changes in the process that will make it easier for hospitals and other providers to respond and to remain on top of things,” said Sandy DiVarco, Partner, McDermott Will & Emery. [...]
EU Parallel Trade Permit: Who Has Burden of Proof that Plant Protection Products and Biocides Are Identical?
On 15 December 2020, the French administrative court specified who bears the responsibility to prove that two plant protection products are deemed identical, even in their packaging boxes, in the context of submitting an extension of a parallel trade permit.
Gritche, a French cooperative company specialised in the wholesale of chemical products, has been entitled to a parallel trade permit since 13 December 2014. The permit allows it to import a wheat and barley fungicide called “Tipi” from the United Kingdom. On 27 June 2017, the company filed an application for an extension to the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) in order to be able to import Tipi from Hungary. The product to be imported under the name “Tipi” holds a marketing authorisation on the Hungarian market under the name “D.” granted to Syngenta AD. Gritche considered that this product D. (which would be imported from Hungary under the Tipi name) was identical to the fungicide D. that Syngenta France SAS is allowed to sell on the French market.
On 31 July 2018, the ANSES reached its conclusions regarding the extension request for Tipi’s trade permit. The ANSES estimated that the active ingredients found in the Hungarian product D. and the one authorised in France under the reference D. had the same origin, and that both products’ composition was identical. However, the ANSES stated that the information at its disposal did not make it possible to ascertain whether the packaging was identical. Thus, [...]
McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health System CEO Panel: Strategic Business Priorities
Our panel included a discussion on what is ahead for 2021 and how the challenges of COVID-19 will lead to lasting changes for hospitals and health systems, with Lloyd Dean (CEO, CommonSpirit), Melinda Estes, MD (President and CEO, St. Luke’s Health System) and Jaewon Ryu, MD (President and CEO, Geisinger). These top healthcare leaders discussed the short- and long-term impact of COVID-19 on hospitals and health systems and their strategic business priorities in 2021 and beyond with moderator Kerrin Slattery (Partner, McDermott Will & Emery).
Below are the top takeaways for McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health System CEO Panel: Strategic Business Priorities, click here to access the full webinar.
Access the PDF here.
HOW 2020 PRIORITIES WILL SUSTAIN AND PROVE HELPFUL IN 2021 AND BEYOND
For hospitals and health systems, 2020 began and was primarily focused on issues like cost and payment models, Medicaid expansion and the wellbeing of clinical providers, including physicians, where statistics cite 40% are burned out. SinceCOVID-19, hospitals instantly pivoted to healing their communities and their staff, as well as rejuvenating the delivery system. “I was very pleased to chair a task force on COVID-19 pathways to recovery that produced a dynamic document that has [...]
McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Digital Health Pioneers Forum
Top industry executives BJ Moore, Executive Vice President and Chief Information Officer, Providence St. Joseph Health; Dr. Ali Parsa, Chief Executive Officer, Babylon Health; and Lucia Savage, Chief Privacy and Regulatory Officer, Omada Health, discussed the evolving doctor-patient relationship and the digitized data and technology convergence with healthcare delivery and payment along with moderators Dale C. Van Demark, Partner, McDermott Will & Emery; Rachel S. Hall, Partner, Digital Health Leader, EY; Stephen W. Bernstein, Partner, McDermott Will & Emery; and Lisa Schmitz Mazur, Partner, McDermott Will & Emery. They also provided insight into 2021’s regulatory considerations affecting healthcare innovation and its solutions.
Below are the top takeaways for McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Digital Health Pioneers Forum, click here to access the full webinar.
Access the PDF here.
CARE OF THE FUTURE
We are only seeing the beginning of the decentralization of care through information technology; but that shift is how scalable solutions to our health care challenges will develop. “Care delivery at home, where we can send patients home and remotely monitor them—eventually that will evolve to things like wearables -IoT devices- that we may have in our clinical settings. We’re seeing the hospitals play such [...]
Life Sciences Dealmaking Symposium: As the Dust Settles: Post-Election Update and Impact on the Life Sciences Industry
How will the election affect life sciences in 2021 and beyond? What’s ahead for the regulatory and policy environment? In this session, our elite group of policy analysts reviewed the election results and the far-reaching effects for dealmakers, executives and investors.
Eric Zimmerman, global head of McDermott’s Health Industry Advisory Practice Group, moderated this discussion that featured insights from Susan Van Meter, executive director at AdvaMedDx; Rodney Whitlock, PhD, vice president at McDermott+Consulting; and Brian Fortune, senior managing director at Farragut Square Group.
Below are the top takeaways for Life Sciences Dealmaking Symposium: As the Dust Settles: Post-Election Update and Impact on the Life Sciences Industry, click here to access the full webinar.
Access the PDF here.
President-Elect Biden’s legislative experience likely will help him reach across the aisle and engage with Republican congressional leadership to advance policy goals. “Biden spent his whole career on the Hill before he became vice
president, so he really understands how his colleagues tick, and he particularly understands the process of how the Hill makes sausage,” Mr. Fortune said. “That’s something that you can’t really say about either President Obama or President Trump. So, not surprisingly, you saw that when they had all the majorities lined up in their favor, they could move stuff, but when they didn’t, it became a little harder.”
With only a narrow projected majority in the US House of Representatives, Democrats will need to work together more effectively and reach [...]
The pursuit of progress during these unprecedented times has led to a surge in life sciences investment and funding for early stage companies. Investors are on the lookout for the next big innovation while also navigating new ways of sourcing and managing portfolio companies. Our panel of experienced early-stage investors discussed the top trends in this push for advancement, including sectors attracting the most dollars in today’s challenging business landscape, key issues that early stage investors are watching as they source and vet new investment opportunities, steps that executives of early-stage companies can take to articulate their value and attract investors, and more.
McDermott partners Todd Finger and Joanna Lin moderated this discussion featuring Eric Aguiar, MD, partner at Aisling Capital; Dr. Andrew ElBardissi, partner at Deerfield Management; and Marian Nakada, vice president of venture investment at J&J Innovation.
Below are the top takeaways for Life Sciences Dealmaking Symposium: Powering through the Pandemic: Trends in Early-Stage Investment, click here to access the full webinar.
Access the PDF here.
COVID-19 fundamentally changed the process for evaluating new investment opportunities, Dr. ElBardissi said. “Meeting face-to-face with the management team, kicking the tires, touring the facility—those are intangible factors
that are very difficult to replace in this corporate environment,” he said. “Candidly, the bar has gotten significantly higher, as you think about our inability to conduct diligence the way we would like and as you think about all the constraints in the current environment.”
Navigating the ever-changing global life sciences deal landscape has become more challenging in the post-pandemic world. Conducting virtual inspections and examining security and privacy risks for remote working and new operating procedures will be central to evaluating current and future collaboration partners and targets. Thinking quickly yet carefully is essential for successfully adapting to this new normal. This panel explored the critical issues that executives and investors should watch out for in a post-COVID-19 world.
McDermott partner Michael Siekman moderated this discussion featuring Tom Brida, general counsel and chief compliance officer at Invitae; Dr. Anna French, partner at Qiming Venture Partners; Chuck Wilson, president and CEO of Cogent Biosciences; McDermott attorney Jennifer Bock; and Laura Jehl, global head of McDermott’s Privacy and Cybersecurity Practice Group.
Below are the top takeaways for Life Sciences Dealmaking Symposium: New Factors in the Mix: Diligence in the Time of COVID-19, click here to access the full webinar.
Access the PDF here.
The COVID-19 pandemic has forced dealmakers to conduct due diligence virtually, using tools such as videoconferencing and virtual data rooms more than ever before. In some ways, this shift has actually made the due diligence process more efficient, the panel observed. With the complications of travel replaced with the convenience of videoconferencing, some aspects of the process are moving along more quickly than before the pandemic shutdown.
Despite increased efficiencies, lack of in-person interactions may impact deal pipelines long-term as investors move from doing deals [...]