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

After the Curve Podcast: Focus on Transactions

The lasting impact of COVID-19 on healthcare transactions is multifaceted and has rapidly altered the trajectory of the dealmaking landscape as well as business collaborations. On this episode of the After the Curve podcast, we discuss how the COVID-19 pandemic is affecting healthcare transactions today, as well as the outlook for the healthcare deal landscape post-COVID-19. McDermott’s Chief Marketing Officer Leslie Tullio is joined by Jed Spielman and Kevin Miller to discuss topics surrounding the impact of the pandemic on healthcare transactions, including: The sectors of the healthcare industries that are most likely to experience a surge in deal volumes and why COVID-19-induced programs that have altered the way healthcare transactions are getting done Which transformational aspects of transaction protocol are most likely to carry into the post-COVID-19 future Insights from the transactions perspective and a look at the most promising upcoming...

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After the Curve Podcast: Focus on Regulatory and Enforcement

COVID-19 led to major policy changes impacting how healthcare is delivered and reimbursed but only some of these new policies will endure in coming years. On this episode of the After the Curve Podcast, we discuss how the regulatory landscape and enforcement priorities may shift in both the short and long term as we transition to the post-COVID-19 era. McDermott’s Chief Marketing Officer Leslie Tullio is joined by Monica Wallace and Emily Jane Cook to discuss topics surrounding pandemic-induced regulatory and enforcement changes, including: A definition of “robust” enforcement activity and how internal compliance teams can prepare to navigate that environment Steps to take when preparing for audits in order to avoid enforcement actions The importance of proper documentation in a rapidly changing environment Current enforcement actions and government inquiries around the country and how to respond to them Anticipated lessons learned from this pandemic and...

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After the Curve Podcast: Focus on Providers

COVID-19 led to major policy changes impacting how healthcare is delivered and reimbursed but only some of these new policies will endure in the coming years. On this episode of the After the Curve Podcast, we discuss how provider organizations can innovate their business models and care delivery to adapt and thrive in a post-COVID-19 world. McDermott’s Chief Marketing Officer Leslie Tullio is joined by Sandy DiVarco and Emily Cook to discuss topics surrounding the impact of the pandemic on healthcare provider organizations, including: The value of government-provided playbooks for healthcare providers in national situations Proper handling of the volume and dynamic nature of information that is conveyed to healthcare providers The impact that the increased demand of telehealth will have on the industry from a regulatory perspective The benefit of telehealth to hospitals and healthcare providers through the COVID-19 months and into the future Key points...

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DEA Proposes Regulations for Emergency Medical Services Agencies

On October 5, 2020, the US Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking establishing a registration category for emergency medical services (EMS) agencies and more generally implementing the requirements of the Protecting Patient Access to Emergency Medications Act of 2017. The majority of the proposed regulations closely track the Act. For example, the proposed rule would: Add EMS agencies as a new category of DEA registrants Allow an EMS agency to obtain one DEA registration for each state where the EMS agency operates (regardless of number of locations within a state) Allow hospital-based EMS agencies to operate using the hospital’s DEA registration. The DEA also exercised its authority to implement the purposes of the Act more broadly with additional proposed regulations, including: Requirements around notice to the DEA prior to delivery of controlled substances to unregistered locations of the EMS agency Requirements (and...

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After the Curve Podcast: Focus on Life Sciences

In this time of crisis, the life science industry has demonstrated remarkable speed, innovation and resilience. In this episode of the After the Curve podcast, our life sciences partners join us to discuss the most promising areas of drug discovery and device development that are emerging from the pandemic and the outlook for the industry in a post-COVID-19 world. McDermott’s Chief Marketing Officer, Leslie Tullio, is joined by Stephen Bernstein and Kristian Werling to discuss key topics impacting the life sciences industry today, including: The reasons behind the immunity of life sciences to slowed investments Why more investors are focusing their equity in healthcare and life sciences Promising areas of drug discovery and device development emerging from the pandemic Critical considerations for life science companies regarding rapid regulatory changes Tactics for moving developments forward at an increased speed The importance of Collaborative...

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After the Curve Podcast: Focus on Health Policy

COVID-19 led to major policy changes impacting how healthcare is delivered and reimbursed, but only some of these new policies will endure in coming years. On this episode of the After the Curve podcast, our colleagues from McDermott+Consulting join us to discuss how the pandemic has changed the conversation leading up to the November presidential election and how key policy issues will evolve in the months and years to come. McDermott’s Chief Marketing Officer Leslie Tullio is joined by Eric Zimmerman, Mara McDermott and Jessica Roth to discuss topics surrounding the pandemic-induced policy shifts, including: The most impactful regulatory telehealth changes that have resulted from COVID-19 A look beyond telehealth to a paradigm shift in the broader digital health landscape The impact that a more refined data exchange pathway could have on treatment during the next wave of COVID-19 or future pandemics Meaningful collaborations that are currently happening in...

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Regulating Medical Devices Post Brexit

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in England, Wales and Scotland after the BREXIT transition period (different rules will apply to Northern Ireland). This On the Subject outlines key dates for implementation of the new rules and certain practical implications of changed regime. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance (the Guidance) on new rules that will govern the regulation of medical devices after the end of the transition period. Whilst some of this guidance is similar to guidance issued as part of the “No deal BREXIT” publications in 2019, the MHRA has also set out proposals to engage and consult on a new medicines and medical devices regulatory framework for the UK. The UK left the European Union (EU) in January 2020 but is...

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5 Questions with a Health Lawyer: Steven J. Schnelle

Steven J. Schnelle Practice Focus Area: Healthcare Office: New York Years at Firm: 2.5 years What is your favorite part about practicing healthcare law at McDermott? Without a doubt, the people! Every day I have the pleasure and honor of working with brilliant and unique colleagues that recognize and appreciate one another’s contributions to our team, both personal and professional. And I’m not just talking about my colleagues with signatures bearing the McDermott logo—our clients are doing amazing things and give us the opportunity every day to engage creatively and collaboratively to make a difference. There’s nothing better than celebrating an achievement with people you care about! What is the biggest opportunity and greatest challenge facing clients in your area of focus today? I think they’re one and the same—the dynamism of the healthcare system in the United States. With constantly evolving laws, regulations, interpretive guidance, enforcement...

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Physician Enterprises After COVID-19: Capturing and Assessing Opportunities

Independent physician enterprises continue to experience unprecedented challenges as a result of the ongoing COVID-19 pandemic. These challenges will linger for the foreseeable future and will have lasting impacts on operations and the provision of care. As a result, transactional opportunities have also shifted, and physician enterprises must be prepared to identify and evaluate new opportunities wherever they may occur. Our recent webinar with leaders from Providence St. Joseph Health, SullivanCotter, DMG Physician Organization, Veralon Partners and Golden State Dermatology explores the key challenges facing physician enterprises at this time and what healthcare providers and investors are looking for in transaction partners for today's healthcare landscape. Click here to listen to the webinar recording and read on for key takeaways from the program.   Independent physician interest in management service organization (MSO) models continues to increase....

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Public Hospital M&A: Know Your Stakeholders

Hospital transactional activity has soared over the last decade, and many public hospitals are evaluating M&A opportunities against the backdrop of the Coronavirus (COVID-19) pandemic. In our previous post on public hospital M&A, we discussed financial pressures on public hospitals, trends driving M&A, and external factors shaping public hospitals’ choices of M&A partners and formats. In this installment, we’ll cover strategies for gaining stakeholder buy-in as hospital board members, senior leaders and advisors move through the transaction process. For a deeper dive into these topics, listen to our podcast, Driving the Deal: Public Hospital M&A and Stakeholder Buy-In. Stakeholders: Who’s Who Public hospital M&A is a team sport. Assessing and advancing a potential deal involves engagement with a wide variety of stakeholders, each with their own perspectives, objectives and priorities. Key players can include elected public officials,...

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