regulatory compliance Archives - HEALTH & LIFE SCIENCES NEWS

regulatory compliance

Regulatory Disputes With HHS: When to Negotiate and When to Litigate

by McDermott Will & Emery | Apr 9, 2021 | Hospitals & Health Systems, Life Sciences

For healthcare and life sciences companies, regulatory disputes with the US Department of Health and Human Services (HHS) and its operating divisions can present significant economic and reputational risks. Efficient resolution of such disputes is always preferable and requires a thorough grasp of both the law and the institutional relationships among the relevant HHS operating divisions, other parts of the Executive Branch, and agency personnel. When a company cannot reach an efficient resolution through negotiation and litigation is the only option, the company must vindicate its rights in a principled way that mitigates reputation risks.

In this webinar, McDermott partners Brian R. Stimson and Brian J. Malkin draw on their backgrounds with HHS and the US Food and Drug Administration, respectively, to help in-house healthcare and life sciences lawyers successfully navigate regulatory disputes with HHS and its operating divisions. Read on for select highlights from this insightful discussion.

The Administrative Procedure Act (APA) sets out the operating principles around which HHS is organized and gives litigators a lens through which they can assess agency efforts to implement policy. Among other things, the APA defines the parameters and procedures for bringing an action against the agency.
Stakeholders generally have the best chance of successfully litigating under the APA when they can challenge an agency action as contrary to the law. “Once you veer into the agency’s deference in interpreting the law, or the agency’s deference in administering a statute, it becomes very difficult under the APA to prevail, because the [...]

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Managed Care Spotlight: 2020 Year in Review and 2021 Outlook

by McDermott Will & Emery | Jan 29, 2021 | Hospitals & Health Systems

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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Five Questions with a Health Lawyer: Emily Jane Cook

by McDermott Will & Emery | Nov 18, 2020 | Hospitals & Health Systems

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 Regulatory and Enforcement

by McDermott Will & Emery | Oct 15, 2020 | Hospitals & Health Systems

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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Disrupting Healthcare – Constructively: Considerations for Executing Innovation

by Jennifer S. Geetter | Dec 19, 2019 | Digital Health

The healthcare industry is facing significant disruption from new market entrants and technology innovations that have the potential to improve how care is delivered, to lower healthcare costs, and to improve healthcare outcomes. But not all disruption is built to have a sustained and positive impact—how do you tell which innovative technologies and ventures will change healthcare for the better, and which are just noise?

We all hear about disruptive innovation – the power of innovative thinking that sees beyond traditional ways of doing things in favor of new, better methods. When innovators enter the health arena and consider its problems creatively, they seek to break down inefficient aspects that don’t work well for stakeholders and patients. Problems can arise, however, if these innovators simultaneously disrupt processes or protective expectations that serve important functions. Healthcare is a heavily regulated and normative environment—for good reason. Many of its laws and norms function to keep patients safe and clarify roles and responsibilities. This post explores key considerations for new entrants into the healthcare marketplace.

Know Your Audience

To help ensure that disruption is constructive, make sure you understand the needs of your customers and their obligations to their customers and internal stakeholders. Because hospitals, health plans and providers, for example, must operate within a complex regulatory environment, your product or service needs to take those constraints into account. No matter how powerful your technology is, if it shifts regulatory burden onto your customers’ shoulders, it risks being unadoptable.

Data privacy presents a [...]

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Five Questions with a Health Lawyer: Drew Elizabeth McCormick

by McDermott Will & Emery | Jul 30, 2019 | Uncategorized

Drew Elizabeth McCormick
Associate
Office: Boston
Years at Firm: 2

What is your favorite part about practicing health care law at McDermott?

I get to work with world class lawyers on cutting edge issues and help our clients navigate the challenges of succeeding in a very dynamic, heavily regulated industry. I am constantly being challenged and learning new things, all while having the honor of helping guide our clients in transforming health care.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?

Definitely the ability to take on risk and succeed in a value-based payment paradigm. We are seeing many shifts in the industry, which are largely being driven by fundamental changes in reimbursement structures away from fee for service. Compounding this, the regulatory framework is lagging behind in many regards, creating tensions and uncertainty that our clients lean on us to help them resolve.

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Five Questions with a Health Lawyer: Kate McDonald

by McDermott Will & Emery | Jun 11, 2019 | Health M&A, Managed Care

Kate McDonald
Partner
Office: Washington, DC
Years at Firm: 6

What is your favorite part about practicing health care law at McDermott?

The health care regulatory work we do is cutting edge. From the largest health care companies to the smallest start-ups, our clients tend to be highly sophisticated and they come to us with high stakes questions that have no easy answers. We help clients navigate a complex web of health care regulations to implement innovative business models or bend the cost curve. The work I do is intellectually challenging and I love partnering with my crazy smart colleagues to solve problems. This is what keeps me coming back to work day after day.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?

There is so much innovation occurring in the health care market today, and in particular in the managed care industry. Health insurers are partnering with an increasingly diverse set of business partners in an effort to provide higher quality care more efficiently, while actually keeping people healthier and improving their experience in the health care system – both of which inure to the benefit of both health insurers and consumers. While health care payors are at a critical intersection and have a unique opportunity to influence changes in the system, figuring out the best [...]

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Five Questions with a Health Lawyer: Amanda Enyeart

by McDermott Will & Emery | Apr 30, 2019 | Uncategorized

Amanda Enyeart
Partner
Office: Chicago
Years at Firm: 4

What is your favorite part about practicing health care law at McDermott?

Definitely our people. I love the depth and breadth of expertise among my colleagues. We have highly experienced lawyers in just about every health care niche you can think of and this allows us to take on client work with confidence. On top of that, we have lawyers who are gifted strategists who can take a holistic and critical look at an issue from a broad perspective. I am constantly learning from my colleagues.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?

Our clients have the potential to transform health care delivery and improve quality of care. We see forces aligning such as changes in payment models to reward value rather than volume and the integration of advanced technology in health care settings to support health care diagnosis and decision making that could actually result in improved health outcomes for many people. Sometimes it seems like all you hear is a lot of hype and speculation – but we get to see through our interactions with clients that some things are really changing.

The flip side is that biggest challenge to this innovation is regulatory compliance that has not kept pace with the changes in health care. There is a real struggle for resources in health [...]

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Five Questions with a Health Lawyer: Karen Owen Gibbs

by McDermott Will & Emery | Feb 28, 2019 | Reimbursement

Karen Owen Gibbs
Partner, McDermott Will & Emery
Office: Chicago
Years at the Firm: 5

What is your favorite part of practicing health care law?

US health care law is interesting, fast-changing and relevant to virtually every person in the United States. As the health care space changes to incorporate new technologies and adjusts to meet patient expectations, I work with my clients on a range of issues that were not on the radar 10 or even five years ago. For example, I do a lot of work in the pharmaceutical industry, including facilitating collaborations between traditional pharma companies and new players, helping clients address reimbursement challenges resulting from the transition to value-based care, and helping providers navigate the opioid crisis. It’s an exciting time to help clients bring new and better care to patients.

What is the biggest opportunity and the greatest challenge facing clients in your area of focus today?

The challenge and the opportunity are closely related. Many clients are seeking to maximize opportunities within today’s rapidly evolving regulatory and reimbursement climate. Current health care policy is highly focused on delivering better care to more people at a lower cost. Our clients are looking for opportunities to deliver on that challenge. That can include collaborating with partners from outside the health care industry such as [...]

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Collaborative Transformation: Shaping the Future of Health Care, Together

by McDermott Will & Emery | Oct 19, 2018 | Digital Health, Health M&A, Hospitals & Health Systems, International Health, Life Sciences, Managed Care, PPM/ASC

As the health care and life sciences fields experience ever-increasing levels of disruption, diverse entities across the industry are teaming up to embrace and foster innovation. These new pairings are shaping the future of health care, as organizations come together to tackle the industry’s most pressing issues with redoubled agility and pooled resources.

In an environment of change and uncertainty, this trend of Collaborative Transformation is yielding improved financial outcomes, increased operational efficiencies, and a fresh infusion of diverse talent and perspectives—all of which result in enhanced quality of care.

This is where the McDermott Health and Life Sciences team comes in. As a top-ranked US health law practice and a leader in life sciences with decades of experience advising the leading players in US and cross-border health and life sciences, we have the skill, market insight and ingenuity to partner with you wherever your innovation takes you. Whether you are forming innovative alliances across borders and industries, creating or implementing groundbreaking technologies and services, or restructuring investments to position your organization at the cutting edge of the market, our team can work alongside yours to achieve excellence.

Click here to learn more about McDermott Health, our recent work executing collaborative transformations on behalf of our clients and how we can help your organization form innovative business relationships.

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