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
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Five Questions With a Life Sciences Lawyer: Michael Ryan

Michael Ryan
Practice Focus Area: Market Access (Diagnostics, Life Sciences)
Office: Washington, DC
Years at Firm: 16

What is your favorite part about practicing life sciences law at McDermott?
Clients come to us with difficult questions that require not just a command of the law, but an in-depth understanding of their business – and in some cases, the technology that makes their business different. Even after more than 16 years, I’m constantly learning something new, and the job is never boring!

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
Diagnostics companies face a lot of challenges, such as IP and fundraising. But in my corner of the world, the biggest problem is the timeline to reimbursement. It can take companies three to five years to get reimbursement from the time they think they’re market ready. The length of this pathway creates many challenges, but also substantial opportunity for those clients who are able to make it through.

What advice would you give to junior lawyers looking to build their practice in your focus area?
Be curious, particularly when it comes to the science underlying a technology. Many lawyers are reluctant to get too “in the weeds,” but it can be a real differentiator when your clients see that you really understand how the technology works and how [...]

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Top Takeaways | Risk-Adjustment Roulette: Strategies for Navigating the Shifting Landscape

McDermott Will & Emery Partner Ankur Goel moderated a panel during the Value-Based Care Symposium that focused on the risk-adjustment landscape and provided insights into how the regulatory environment and contractual partnerships may continue to shift in the coming years. The panelists shared their experiences navigating the current enforcement environment and the corresponding impact on value-based care and investment opportunities.

Session panelists included:

  • Jeffrey De Los Reyes, Managing Director, Alvarez & Marsal, Healthcare Industry Group
  • Wayne T. Gibson, Senior Managing Director, FTI Consulting
  • Kanika Sabor, Managing Director, Healthcare Disputes and Economics, Ankura Consulting
  • Timothy J. Wilder, FSA, MAAA, Principal and Consulting Actuary, Milliman

Top takeaways included:

  1. Increased complexity of RADV audits. The methodologies for risk adjustment data validation (RADV) audits are more complex and have a broader reach than before, impacting how sampling is approached and how extrapolation is allocated back to providers by Medicare Advantage (MA) plans. The recent changes apply to US Centers for Medicare & Medicaid Services (CMS) and Department of Health and Human Services (HHS) Office of Inspector General (OIG) RADV audits, which means the potential financial risk is higher. Providers and Medicare Advantage organizations must analyze the potential impact of these changes and become better prepared to respond to these audits.
  2. Greater collaboration between payors and providers. The changes brought about by the RADV audits will likely encourage more collaboration between payors and providers, as both parties will need to be more knowledgeable about what goes into their payments. Payors may also [...]

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Top Takeaways | Employer Market Perspective

In this session, McDermott Will & Emery Partner Patrick Healy moderated a panel that examined the expansion of value-based care in the employer market. We summarize the panel’s insights on how stakeholders can successfully implement value-based models in the employer market.

Session panelists included:

  • Mark Miller, Chief Commercial Officer, Wildflower Health
  • Simeon Niles, Vice President of Health Care Innovation, Morgan Health
  • Carl Landry III, Director, Healthcare Strategy, Guidehouse

Top takeaways included:

  1. Motivated by the unsustainable increase in healthcare spending and new consolidation and joint ventures among providers and health insurers, there is an accelerated need for solutions in the employer market. If the employer market does not self-regulate, the market fears that regulators will step in.
  2. Regarding the relationship between employers with self-funded plans and third-party administrators (especially those owned by health insurers), there is confidence that third-party administrators’ historical relationships with employers will generate more turnkey programs producing easier-to-integrate value-based care models.
  3. There is a particular emphasis on how smaller employers will utilize employee data and implement value-based care models in comparison to jumbo employers.
  4. Significant interest in the jumbo-employer market is met with limited adoption and penetration of value-based care models when compared to the Medicare/Medicaid space. It is unclear whether these challenges are due to structural issues in the employer market limiting the pace of adoption. Such structural issues include employers as individual purchasers of coverage (as opposed to aggregate bulk purchasers); associated pools of covered lives too small for providers to take risk; [...]

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VBC Symposium 2023 | Washington Update

During this session, Mara McDermott, former Vice President, McDermott+Consulting, moderated a panel that discussed the current political and policymaking environment on Capitol Hill and what to watch for in 2023.

Session panelists included:

  • Dr. Lauren Lyles-Stolz, Senior Director, Reimbursement, Innovation and Advocacy, National Association of Chain Drug Stores (NACDS)
  • Aisha Pittman, Senior Vice President, Government Affairs, National Association of ACOs (NAACOS)
  • Soumi Saha, Senior Vice President of Government Affairs, Premier Inc.
  • Moderator: Mara McDermott, former Vice President, McDermott+Consulting

Top takeaways included:

  1. Legislative and regulatory stakeholders have created a number of opportunities to engage in value-based care, including through the creation of the Center for Medicare and Medicaid Innovation (CMMI) and the Medicare Shared Savings Progam (MSSP). However, many of these initiatives have been—and continue to be—influenced by political and agency decision making. Therefore, educating members of Congress on why value is important remains a top priority.
  2. Stakeholders are advocating for greater predictability and alignment across value-based initiatives. There are many competing interests in the system today, with Centers for Medicare & Medicaid Services (CMS) initiatives trending in different directions (e.g., Medicare Advantage versus MSSP). There are questions regarding how pharmacy services can better integrate into value-based care, how to engage specialists, how to sustain Medicare Advantage and more. Creating a pathway for all of these initiatives and stakeholders to coexist will be challenging, but could lead to greater value.
  3. Better data is needed across programs. Faster, higher-quality data would allow CMS to more quickly cost-correct during the [...]

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Investing In a Healthier Future: The Investor’s Perspective On Value-Based Care

In this session, McDermott Will & Emery Partner Joel Rush moderated a discussion exploring investors’ interests in, opinions on and strategies for entering the value-based care (VBC) market. The panel discussed factors taken into consideration when choosing if and when to invest in VBC opportunities, issues that arise when collaborating with health systems, and ways to evaluate risk models and support improved care delivery.

Session panelists included:

  • Lauren Brueggen, Partner, Heritage Group
  • Devin Carty, Chief Executive Officer, Martin Ventures
  • Roger Kueny, Senior Vice President of Corporate Development, Alignment
  • David Pontius, Partner, WindRose Health Investors
  • Karey Witty, Managing Director, Valtruis

Top takeaways included:

  1. When it comes to investing in VBC, the tailwinds are just beginning to pick up after the COVID-19 pandemic reduced reimbursement volume. During that time, physician practices that were leaning on fee-for-service (FFS) reimbursements saw their volumes drop close to zero during the COVID-19 pandemic. Hospitals began to get crushed by the rates, and much of the volume has yet to return to normal. One way to solve this problem is by moving physician practices into VBC and to demonstrating that VBC is a bonus, not a penalty, and probably the only way to get back to the earnings they previously had. Also, when looking at hospital systems, investor-based hospitals performed significantly better during the pandemic. Innovative programs like the Accountable Care Organizations Realizing Equity, Access, and Community Health (ACO REACH) model are showing hospitals and physicians that the market is experiencing a technology shift, [...]

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Top Takeaways | How to Succeed in CMMI Payment Models

In this session, McDermott Will & Emery partner Matthew Perreault moderated a panel that discussed the current state of value-based care in original Medicare and lessons learned from the panelists’ experiences with various Center for Medicare & Medicaid Innovation (CMMI) models.

Session panelists included:

  • Rob Cetti, President, CareAllies
  • Stanley D. Crittenden, MD, FASN, CHS, Chief Medical Officer, Evergreen Nephrology
  • Tim Gronniger, Chief Value-Based Solutions Officer, Signify Health
  • Kim Phan, Chief Executive Officer, CareConnectMD
  • Moderator: Matthew Perreault, Partner, McDermott Will & Emery

Top takeaways included:

  1. When evaluating participation in CMMI models, stakeholders should recognize that the models are focused on innovation and may be more susceptible to redesign and changes in CMMI priorities than Medicare Shared Savings Program (MSSP) models. Participants in CMMI value-based care models must be ready to engage with changes that will impact revenue. The desire of the Centers for Medicare & Medicaid Services (CMS) to build around full-risk models and streamline benchmarks may have larger-than-anticipated economic impacts for stakeholders with conservative investment views.
  2. High-needs populations under the Accountable Care Organizations Realizing Equity, Access, and Community Health (ACO REACH) and specialty models, such as the Comprehensive Kidney Care Contracting model, offer an opportunity to address historically neglected patient populations. To succeed, companies must align with physicians to ensure that their physicians understand and employ the right tools to improve the quality measures that CMS establishes, such as patient activation measures, and foster patient engagement.
  3. In contrast to the widespread adoption of ACO participation by primary [...]

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VBC Symposium 2023 | Find Your Niche: Value-Based Models for Clinical Specialties

During this session, Partner Jeremy Earl moderated a panel that collected insights on how specialists can participate in value-based care and the unique challenges specialists face in maximizing value-based care opportunities.

Session panelists included:

  • Marissa Brittenham, Executive Vice President and Chief Strategy Officer, Surgery Partners
  • David Dempsey, Chief Operating Officer, Heartbeat Health
  • David Eagleton, Senior Vice President, Oncology Care Partners
  • Josh Goldenberg, Group Vice President of Payor Partnerships, DaVita Inc.
  • Moderator: Jeremy Earl, Partner, McDermott Will & Emery

Top takeaways included:

  1. While some specialists are comfortable in the value-based care world, others have been slow to engage with and adopt value-based care initiatives. Convincing providers who have been paid on a fee-for-service basis their entire career to shift and take on risk can be challenging. These shifts can begin slowly, for example, by offering initial quality bonuses and then building up to longer-term strategies. However, the transition often involves a shift in mindset and can be challenging to accomplish at an organizational level.
  2. Specialists may only have insight into a small portion of a patient’s life, so it can be hard to engage in the patient’s full care journey when specialists are not at the center of care. However, where specialists can provide a service for a fraction of the cost—for example, through site-of-care shifts—specialists can still have a large impact on costs and outcomes.
  3. Different specialties are at different points in the value-based care transformation. The panelists representing ASCs and oncology, cardiology and dialysis providers, for [...]

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VBC Symposium 2023 | Innovations in Value-Based Care for Complex Populations

During this session, Partner Jeremy Earl moderated a panel that discussed how value-based care models are delivering care to individuals with complex conditions and those with significant healthcare and social needs. The panel also provided perspectives from executives at companies that are revolutionizing the delivery of care to high-needs populations and demonstrating how doing good can also be a successful business model.

Session panelists included:

  • Christopher Aguwa, Executive Vice President & Head of Growth and Business Development, Cityblock
  • Benjamin Kornitzer, MD, Chief Medical Officer, agilon health
  • Hank Watson, Chief Development Officer, American Health Partners
  • Lea Tompsett, Head of Provider Enablement, Waymark

Top takeaways included:

  1. Focus on Empowering and Elevating Providers. The companies that are successfully delivering care to complex populations are those that are focused on empowering and elevating providers to fill in gaps in care; such entities also succeed on cost and outcome goals as a result. These companies primarily focus on primary care providers (PCPs), nursing homes and related front-line providers. The panelists who focus their efforts on primary care do so in the belief that primary care can have the greatest impact on outcomes. Traditionally, primary care has been delivered within the four walls of a PCP’s office, with fee-for-service (FFS) reimbursement. Companies take different approaches to moving outside of this traditional model: Some focus on extending services outside of the PCP’s office to fill in gaps in care, such as deploying nurses to the home. Others seek to enable PCPs with data and [...]

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VBC Symposium 2023 | Weathering The Storm: A Data-Driven Perspective on Value-Based Care, by Bain & Company

In this session, Erin Ney and Jason Slocum of Bain & Company provided data-driven insights on the current state of the value-based care industry. The session provided a look at the factors influencing provider adoption of risk-based adoption, the most promising investment opportunities in value-based care, and how likely the value-based care industry is to weather an economic downturn.

Top takeaways included:

  1. Nearly 60% of healthcare payments in 2021 had at least some element tied to quality and value. However, the majority of these payments were upside risk, with less than 20% incorporating down-side risk. At the same time, nearly 40% of healthcare payments are not in value-based care models.
  2. Around 80% of physicians surveyed are interested in participating in value-based care arrangements. However, that interest significantly decreases as the level of risk to the provider increases.
  3. Providers continue to face financial, operational and administrative hurdles to adopting value-based care. Providers’ sense of preparedness across the financial, operational and administrative dimensions have decreased since 2017, with providers surveyed feeling less equipped to adopt and succeed in value-based care models.
  4. To make providers more inclined to adopt value-based care, providers stated that they needed more sufficient financial resources, more effective coding and billing processes, and investments in additional staff to manage data, reporting and outreach. Similarly, providers reported they needed three key groups of enablers in order to transition from fee-for-service to risk-based models: (1) clinical care model enablers, (2) data and technology enablers, and (3) payor contracting enablers.
  5. There [...]

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This Week in 340B: January 31 – February 6, 2023

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.

Issues at Stake: Medicare Payment; Contract Pharmacy
Where Things Stand:

  • In three Medicare payment cut cases, the district court judge has signaled her inclination to transfer the cases to the judge handling most other Medicare payment cut cases, and has asked for the parties to enter any objections to a transfer.
  • In one contract pharmacy case, the parties requested a stay pending the D.C. Circuit Court’s ultimate decision in Novartis Pharmaceuticals Corp. v. Johnson and United Therapeutics Corp. v. Johnson.
  • The drug manufacturer party in a contract pharmacy-related antitrust case filed a letter with the court to advise it of the Third Circuit Court of Appeals’ recent decision in Sanofi Aventis v. HHS and ask that it reach the same decision.
  • In the contract pharmacy-related antitrust case, the drug manufacturer parties filed a notice of supplemental authority with the court citing the Third Circuit Court of Appeals’ recent decision in Sanofi Aventis v. HHS in support of their motion opposing the plaintiff’s motion to amended their complaint.

Get more details on these 340B cases with the 340B Litigation Tracker, a subscription product from McDermott+Consulting.




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