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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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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CDC Issues Guidance for Employer-Operated Vaccination Sites

As states across the US expand COVID-19 vaccine eligibility, employers are well-positioned to facilitate vaccine access and improve distribution efficiency. One critical way for employers to achieve these goals is through the operation of workplace vaccination sites, sometimes called closed points of dispensing (CPODs).

On March 16, 2021, the Centers for Disease Control and Prevention (CDC) issued updated guidance on workplace vaccination programs. Among other recommendations, the CDC encourages some employers to implement workplace COVID-19 vaccination sites and outlines best practices for doing so.

According to the CDC, employers with (1) a large number of workers on predictable schedules, (2) the ability to enroll as a vaccination provider or engage an already enrolled vaccination provider, and (3) enough space to operate a vaccination clinic that allows for social distancing should consider operating an on-site vaccination program. Conversely, the CDC recommends an off-site vaccination program for small- or medium-sized employers with a mobile workforce on variable schedules.

The CDC provides several options for employers that choose to operate an on-site vaccination program, including existing occupational health clinics, employer-run temporary vaccination clinics, and mobile vaccination clinics brought to the workplace. Regardless of the model, the CDC advises employers to contact their local health department for guidance. Many jurisdictions have already embraced the CPOD model (e.g. Chicago, IL) and provide extensive information on their websites.

The updated CDC guidance makes clear workplace vaccination clinics should [...]

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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. [...]

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Managed Care Spotlight: 2020 Year in Review and 2021 Outlook

The past year saw significant developments in managed care regulation at the federal and state levels and we anticipate the rapid pace of change will continue through 2021. In this webinar, we analyzed the most significant legal developments affecting health plans in 2020 and explored what to expect in 2021. Our thought leaders discussed the impact of managed care regulations on a broad range of industry subsectors, from plans and providers to vendors and pharmacy benefit managers.

PROGRAM INSIGHTS

  • The Biden administration seeks to set a tone of order and predictability in its COVID-19 relief and response efforts. These efforts include a swath of executive orders on topics such as data aggregation, support for the National Guard and strategies for vaccine distribution. The acting secretary of Health and Human Services also recently sent a letter to state governors stating that the agency will likely extend the public health declaration—and its attendant regulatory flexibilities—through 2021.
  • The direct contracting model is the next step in the evolution of the Medicare accountable care organization portfolio. The model allows participating organizations to take on a greater level of financial risk, including the Centers for Medicare & Medicaid Services’ version of global capitation. The direct contracting global or professional options may be particularly attractive to managed care organizations, because these options allow new entrants with low or no fee-for-service beneficiaries.
  • The coming year will likely see a continued trend toward financial risk assumption in value-based contracting. Within this trend, there are two common variations. [...]

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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 [...]

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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 of the
organization is key because that really drives and helps shape the culture of innovation
as an organization. We define innovation in terms of in three buckets, the research
based, hospital based and external or open innovation,” said Kolaleh Eskandanian,
Vice President and Chief Innovation Officer, Children’s National. “So research based
is the traditional model of a transfer, [...]

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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.

There are many options for structuring an innovation center and there is no one-size-fits-all model.
Innovation centers are often custom-built around the organization’s needs and with the input hospitals and health systems receive from their clinicians, board, patients, and community. Determining what innovation model to pursue involves weighing the amount of financial risk the entity will take on, the complexity of the venture, and the expertise available to guide the center’s [...]

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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 for different clients. Keeping on top of all of the changes – both proposed and actual is endlessly challenging for our clients. Helping them sort through the ever-changing laws, regulations and guidance is one of the many ways in which we provide value to our clients.

What kind of client work gets you most excited when it comes across your desk?
The type of work [...]

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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 where we are today
  • Key takeaways for payors moving forward from the pandemic

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