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
Hospitals & Health Systems
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Hospital and Health System Innovation Summit: Lessons Learned: Diligence, Detours and Data, Oh My

Industry leaders shared first-hand lessons learned from their work on recent innovation related projects. We covered a range of case studies, highlighting lessons learned around mission alignment, conflicts of interest, diligence considerations, data ownership and de-identification, and strategies for protecting a minority investor. Below are the top takeaways for Hospital and Health System Innovation Summit: Lessons Learned: Diligence, Detours and Data, Oh My, click here to access the full webinar. Access the PDF here. Mission Alignment It is essential for a hospital and health systems to adopt a formal innovation strategic plan that aligns with its overall strategic mission and vision and clearly articulates it specific innovation goals and prioritizes focus areas. Hospital and health systems pursue innovation initiatives largely to support the clinical mission and drive revenue growth and diversification. “I think that alignment with the strategic mission...

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Hospital and Health System Innovation Summit: Nuts And Bolts: How to Invest in Innovation

There has been increased interest by hospitals and health systems in creating innovation centers and making innovation center investments, which are helping to transform the healthcare landscape. As they enter this space, hospitals and health systems must first decide how to organize to capitalize on and commercialize innovation opportunities to get innovations into the routine of patient care. Joined by leaders from Health Innovation Strategies and Winter Street Ventures/Commonwealth Care Alliance, we discussed the fundamental types of investment structures from the health system perspective, including types of vehicles used by health systems, tips for aligning investment priorities with the health system mission, and collaborations with third parties to accelerate innovation. Below are the top takeaways for Hospital and Health System Innovation Summit: Nuts And Bolts: How to Invest in Innovation, click here to access the full webinar. Access the PDF here....

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Five Questions with a Health Lawyer: Emily Jane Cook

Emily Jane Cook Practice Focus Area: Federal and State Healthcare Regulation and Reimbursement Office: Los Angeles Years at Firm: 11 What is your favorite part about practicing healthcare law at McDermott? Without a doubt, it is the people – both our clients and my fellow McDermott attorneys. Due to the nature of our work we are on the phone (and now video!) for many hours every day, often discussing extraordinarily complex issues. The work itself is rewarding, made even more so when done in collaboration with such brilliant clients and colleagues. What is the biggest opportunity and greatest challenge facing clients in your area of focus today? The answer to both is “change.” Federal and state fee for service programs have been around for decades, but they are always changing. The constant change provides both risks and opportunities for our clients, but often whether or not a particular change may be a risk or an opportunity is unclear – or may be different...

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After the Curve Podcast: Focus on Health Insurance and Coverage

COVID-19 has catalyzed significant changes in the patterns of healthcare delivery, with the potential for long lasting effects on payors as a result. On this episode of the After the Curve podcast, we discuss how the COVID-19 pandemic may shift the healthcare coverage and payment landscape as well as how it may boost integration among payors and providers. McDermott’s Chief Marketing Officer Leslie Tullio is joined by Kate McDonald and Ankur Goel to discuss relevant topics for both payers and the healthcare industry more broadly, including: How COVID-19 is changing healthcare utilization patterns in the US and the impact of that disruption on insurers The reaction from health plans to the financial impact of COVID-19 on providers The impact of telehealth and regulatory waivers at the state and federal levels on the payor market Top lessons that payors have learned from the pandemic and subsequent next steps Opportunities for healthcare leaders to synthesize...

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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 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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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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