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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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 their impact on an organizational level

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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 leaders need to be aware of as the healthcare industry moves beyond the pandemic

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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 options) regarding storage of controlled substances
  • Requirements associated with documentation of individual EMS professionals’ authorization to dispense controlled substances
  • Recordkeeping requirements relating to deliveries of controlled substances among all locations of the EMS agency
  • Recordkeeping requirements associated with controlled substance acquisition, administration and disposal.

Comments on the notice of proposed rulemaking are due by December 4, 2020.




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 the digital health space
  • A look at innovations that are emerging from the demands of post-COVID-19 healthcare
  • Legal and regulatory compliance steps that still need to be taken to allow these telehealth programs to continue in the future

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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 currently in a transition period. The Guidance was released as part of a collection of updates covering various MHRA-regulated sectors (including medicines, clinical trials and licencing procedures) which will also be subject to new rules from 1 January 2021.

This update focuses on the new regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) placed on the market in England, Wales and Scotland (Great Britain) only. Different rules will apply to Northern Ireland.

Existing law to continue
The rules that currently regulate medical [...]

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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.

 

  1. Independent physician interest in management service organization (MSO) models continues to increase. Historically, independent physician practices have been reluctant to shift certain business and office functions to an external management company. However, due to reimbursement and revenue constraints caused by COVID-19, the economies of scale and other cost savings associated with an MSO model may be more attractive to independent physician practices.
  2. Hospitals and health systems are reevaluating their employed physician practice structures. In particular, hospitals and health systems are reassessing their willingness to tolerate significant losses on their employed physician practices and evaluating whether changes in compensation models, compensation levels or the organizational structure of their employed physician networks can create a more sustainable setting. Some health systems are potentially [...]

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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, community leaders, hospital management and board members, physicians, employee unions, patients and the general public. It is critical to navigate the diverse viewpoints of these important stakeholders without ceding decision-making to a non-fiduciary.

As a first step in navigating that challenge, hospital boards should distinguish between stakeholders that have the right to approve or deny the proposed transaction, and those that are important to the deal’s success but do not have approval authority. Depending on the jurisdiction and deal structure, the former category of stakeholders could include the local municipality’s board, the State Attorney General or even registered voters, in the case of a public [...]

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European Healthcare Innovation & Investment in a Post-Pandemic World

As part of McDermott’s HPE Europe 2020: Where Do the Opportunities Exist for Investment in the Healthcare Sector? webinar, McDermott London Managing Partner Hamid Yunis moderated a panel of industry experts including; Dr. Michelle Tempest of Candesic, Dr. Joanne Hackett of IZY Capital, Dr. Charles Niehaus and Professor Karol Sikora of Rutherford Cancer Centres, who collectively shared their perspectives on healthcare innovation and investment in a post-pandemic world.

The panelists agreed that COVID-19 has served as a catalyst for change and which has revealed important prospects for the future.

“There has been this zest for change which we’ve been talking about for a long period of time, and this has finally been that breakthrough,” said Dr. Tempest. “Both the professionals and the consumers have suddenly woken up to this new dawn.”

“What I’ve actually seen in the past couple of months is a lot of innovation that we were really wanting to accelerate are now actually happening,” agreed Dr. Hackett. “And it’s because we’re finally able to look to the future and think about future proofing to make sure that our healthcare system is actually going to deliver. I see positivity.”

Dr. Niehaus emphasized that, the real opportunity at the moment is to take the technologies many people were resistant to pre-COVID now acceptable, and use the shift as a “springboard to actually move forward.”

“We struggle with the cumbersome nature of a nationalized system that doesn’t really encourage entrepreneurism,” Professor Sikora cautioned. “The entrepreneurial skills are there — in [...]

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Unpacking Differences in Public and Private Hospital M&A

Across the public hospital sector, M&A activity has increased significantly over the past decade. Given the current COVID-19 landscape, many are taking a hard look at their operations to garner a better understanding of what needs to be done to be regain level footing during a tough financial time, while also focusing on a need to uphold their community’s best interest. Broadly speaking, many public hospitals are the sole provider in their communities, so making the right M&A choice is vital – not only for them, but those they serve. Here we will discuss the pressures of public hospitals financially, the trends driving M&A and what external pressures are impacting these hospital’s decisions. For a deeper dive into the issues discussed here, listen to our podcast, Dealmaking in the Sunlight: Navigating Public Hospital M&A.

Financial Pressures

Standalone entities, like many public hospitals, often lack economies of scale and do not have the benefit of spreading risk across a larger organization to soften the economic blows impacting hospitals today. However, these struggles do not go unnoticed, as there are regulatory and legal frameworks in place to help public hospitals perform differently or better when needed. Certain government or municipal hospitals have immunity to antitrust laws, which allows them to partner with organizations within their market (“cross town competitors”).

M&A’s Potential Effect on Public Hospitals

M&A amongst hospitals and healthcare systems has been found to increase revenue, improve debt position, and attract resources to the community. Given that information, [...]

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Coronavirus Resource Center | Preparedness Planning for Businesses

In our global economy, Coronavirus (COVID-19) raises serious concerns for employers in all industries. Workers may be on the front lines caring for patients and developing vaccines, travelling for business, or in close contact with individuals who travel or may have been affected. At this time, there is no vaccine or medication approved to prevent or treat the COVID-19 disease. Therefore, preparedness and prevention are crucial. Frontline responders must be especially vigilant as they deliver care and anticipate the challenges this uncharted territory presents.

McDermott’s Coronavirus Resource Center, brought to you by a multi-disciplinary team, will keep you informed of the latest developments and provide comprehensive insight to help you navigate this crisis with your employees, including:

  • Frequently asked questions for US and multi-national employers
  • Recent news updates
  • Podcasts
  • Upcoming events

Click here to access the Resource Center.




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