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PODCAST

Diagnosing Health Care Podcast

Epstein Becker & Green, P.C.

Today"s health care industry is a high-stakes environment full of legal, policy, and regulatory-related obstacles. There are also tremendous opportunities, and in order to thrive, it is critical for executives, general counsel, and administrators to have a consistent pulse on trends and available business solutions. Subscribe to our health care podcast, Diagnosing Health Care, for thought-provoking, strategic insights from Epstein Becker Green attorneys and health care professionals.

health & fitness medicine

All Episodes

33:15

Dietary Supplements: Navigating the Regulatory Maze

Diagnosing Health Care Podcast ·

2023/11/02

The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its health products compliance guidance have done the same. In light of these recent actions, what challenges are dietary supplement manufacturers now facing? On this episode, Epstein Becker Green attorneys Jack Wenik, Teddy McCormick, Zach Taylor, and Tracey Gonzalez discuss recent updates to the FDA and FTC guidelines as

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31:24

Direct Access Laboratory Testing: Future FDA Proposed...

Diagnosing Health Care Podcast ·

2023/09/28

Throughout this series, we've talked about the growth of the direct access testing industry and the types of models developed to support the businesses that are using that type of testing. We've covered reimbursement considerations and physician ordering and specimen collection regulations. How does all of this come together to shape the future of the lab testing industry? On the final episode of our four-part series on direct access laboratory testing, Epstein Becker Green attorneys Bob Hearn,

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37:50

Owner's Outlook: Managing Risks in an Ever-Changing...

Diagnosing Health Care Podcast ·

2023/08/31

The impacts of climate volatility, cybersecurity threats, artificial intelligence, and building information modeling and construction technology have increased pressure on major construction projects on top of labor availability and supply chain adversity. If your approach to delivering construction is the same as it was in early 2020, you're probably inviting more risk to your project than you want. On this episode of our Owner's Outlook series, special guest Alanna Klein, Product Director of

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32:40

Inflation Reduction Act’s Drug Price Negotiation...

Diagnosing Health Care Podcast ·

2023/08/01

In July, the Centers for Medicare & Medicaid Services made significant headway in its implementation of the drug pricing provisions of the Inflation Reduction Act (IRA). How can stakeholders respond to, implement, and comply with all these new provisions? On this episode, hear from special guest Sylvia Yu, Vice President and Senior Counsel of Federal Programs at PhRMA. Sylvia and Epstein Becker Green attorneys Connie Wilkinson and Alexis Boaz discuss the recent updates on the quickly moving

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28:31

Post-Dobbs: One Year Later

Diagnosing Health Care Podcast ·

2023/06/22

The Supreme Court's decision in Dobbs v. Jackson Women's Health Organization one year ago overturned 50 years of legal precedent protecting the constitutional right to abortion in the United States, leaving the question of whether and how to regulate abortion to individual states. What has happened since and what is to come? On this episode, Epstein Becker Green attorneys Amy Dow, Erin Sutton, and Jessika Tuazon examine how the Dobbs decision has impacted the legal landscape for patient access to

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34:33

Managing Trade Secrets and Restrictive Covenants in...

Diagnosing Health Care Podcast ·

2023/05/18

Like the diversity of the industry itself, merger and acquisition (M&A) transactions in health care take many forms, varying in size and complexity. While buyers tend to focus on several things as part of those transactions, securing key employees post-closing is an important but sometimes overlooked issue. What are some important factors to consider when entering a transaction in a human capital-intensive industry like health care? On this special crossover episode of Diagnosing Health

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39:19

The Legal Battle Over Mifepristone

Diagnosing Health Care Podcast ·

2023/05/09

On April 21, 2023, the U.S. Supreme Court ruled to preserve access to the prescription abortion drug mifepristone. However, while the case continues in the U.S. Court of Appeals for the Fifth Circuit, the future of mifepristone—and the U.S. Food and Drug Administration’s authority to approve new drugs—will continue to be debated on appeal. On this episode, Epstein Becker Green attorneys Erin Sutton, Delia Deschaine, and Avery Schumacher analyze the ongoing legal battle over mifepristone and discuss

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39:12

Inflation Reduction Act’s Drug Price Negotiation...

Diagnosing Health Care Podcast ·

2023/05/04

The Inflation Reduction Act (IRA), signed into law in August 2022, included significant and controversial drug-pricing provisions. What key compliance issues must industry stakeholders consider as these provisions are put into effect? On this episode, Epstein Becker Green attorneys Leslie Norwalk, Connie Wilkinson, and Alexis Boaz discuss key considerations for the health care and life sciences industry as the Centers for Medicare & Medicaid Services works its way through the initial stages of

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26:11

Direct Access Laboratory Testing: Physician Orders...

Diagnosing Health Care Podcast ·

2023/04/20

A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection considerations, including how the varying options for collection could impact a model. How do these factors combine to create a roadmap for companies navigating the direct access testing industry? On the third episode of our four-part series on direct access laboratory testing,

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38:09

Legal and Regulatory Landscape for Psychedelics as...

Diagnosing Health Care Podcast ·

2023/04/13

Renewed interest in the potential benefits of psychedelic treatments has led to an upsurge in research. Is the first FDA approval of a psychedelic for therapeutic use on the horizon? On this episode, Epstein Becker Green attorneys Delia Deschaine, Lisa Gora, and Jessika Tuazon examine the history of psychedelic substances in the United States and discuss the evolving legal and regulatory considerations impacting the development, approval, distribution, and use of psychedelic therapies in the United

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32:42

2023 Deal Cycle: Considerations for Transactions in...

Diagnosing Health Care Podcast ·

2023/03/30

The Federal Reserve's steady increase of interest rates and the slowed economic growth have increased fiscal pressure on health care providers, leaving many to look for ways to bridge budget shortfalls through injections of capital, asset sales, or other strategic transactions. What options are there for providers moving forward? On this episode, Epstein Becker Green attorneys John Tishler, Ryan Cochran, and Tim Murphy discuss how the changing economic climate has impacted the 2023 deal cycle and

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32:44

The End of the Public Health Emergency – What’s to Come?

Diagnosing Health Care Podcast ·

2023/03/16

In conjunction with the national COVID-19 public health emergency (PHE), the Centers for Medicare & Medicaid Services and other federal agencies have issued waivers and other declarations with the goal of giving providers flexibility in order to render services during the PHE. How should stakeholders prepare for the end of the PHE on May 11, 2023? On this episode, Epstein Becker Green attorneys Amy Lerman, Jenny Nelson Carney, and Dan Fahey discuss the expiration of the PHE and the impact it will

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36:35

Direct Access Laboratory Testing: Reimbursement &...

Diagnosing Health Care Podcast ·

2023/03/09

When analyzing the lifecycle of any health care product, a key component to consider is how much the product will cost and who will pay for it. What unique challenges do direct access tests pose when it comes to reimbursement and related compliance requirements? On the second episode of our four-part series on direct access laboratory testing, Epstein Becker Green attorneys Bob Hearn and Megan Robertson and EBG Advisor Dr. Joel Brill discuss coverage and reimbursement for direct access tests, as

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33:12

Direct Access Laboratory Testing: Navigating the...

Diagnosing Health Care Podcast ·

2023/02/23

What are the various factors impacting stakeholders in the direct access testing industry? By the end of this four-part series on direct access laboratory testing, listeners will have gained insight into how to navigate the complex regulatory and legal regimes that govern the process of making lab tests available directly to patients and understand the aspects that will dictate how their operations should be structured. On this episode, Epstein Becker Green attorneys Amy Dow, Bob Hearn, James

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23:07

Unpacking FDA's Final Clinical Decision Support Guidance

Diagnosing Health Care Podcast ·

2023/02/09

The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support software (CDS). How has this document caused confusion for industry? How can companies respond? On this episode, Epstein Becker Green attorneys Brad Thompson and Jessika Tuazon analyze the FDA's latest CDS guidance and discuss the challenges industry faces as it attempts to make sense of, and comply, with that guidance. Visit our site for

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32:26

The PACE Program: What Changes May Be Coming Soon?

Diagnosing Health Care Podcast ·

2023/02/02

Changes are on the horizon for provisions of the Program of All-Inclusive Care for the Elderly (PACE) that haven't been updated in over a decade. What exactly is PACE and how will new proposed rule modifications affect PACE plans moving forward? On this episode, special guest Wendy Edwards, Director of Internal Operations at BluePeak Advisors, and Epstein Becker Green attorneys Lynn Shapiro Snyder, Kevin Malone, and Helaine Fingold explore the ins and outs of PACE, the changes in recent years that

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24:53

Post-Dobbs: Considerations for Clinical Trials and...

Diagnosing Health Care Podcast ·

2023/01/26

The Dobbs v. Jackson Women's Health Organization decision, which effectively removed the federal constitutional protections for abortion, triggered a series of changes for health care providers and patients alike across the nation with respect to abortion services. What additional implications are there for certain aspects of clinical trials and research? On this episode, Epstein Becker Green attorneys Kate Heffernan, Marylana Helou, and Megan Robertson discuss how the changing state laws and

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36:06

2023 Health Policy Outlook

Diagnosing Health Care Podcast ·

2023/01/12

With the recent midterm elections changing the composition of Congress, and the Biden administration's first opportunities to advance its policy priorities from the very beginning of the rulemaking process, what are the key health care developments to watch out for in 2023? On this episode, Epstein Becker Green attorneys Ted Kennedy, Jr., Alexis Boaz, and Philo Hall discuss the current landscape of health care policy from both the legislative and regulatory perspectives and analyze which key health

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22:01

Post-Dobbs: Access to Reproductive Health Care and...

Diagnosing Health Care Podcast ·

2022/12/01

In the aftermath of the Dobbs v. Jackson Women's Health Organization decision, important questions have emerged about the current legal and regulatory landscape surrounding patient access to drugs that have historically been used to induce abortions. How can health care providers and pharmacies navigate these new restrictions? On this episode, Epstein Becker Green attorneys Delia Deschaine, Spreeha Choudhury, and Jessika Tuazon discuss the impact of the Dobbs decision on pharmacies and pharmacists,

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29:13

Owner's Outlook: National Trends in Construction Claims

Diagnosing Health Care Podcast ·

2022/11/17

The past three years have been tumultuous in the health care construction economy, and the patterns in recent construction claims might surprise some. Which types of claims are popping up, in what regions are they appearing, and what types of facilities are involved? On this episode of our Owner's Outlook series, special guest Brett Lamb, co-founder and CEO of Construction Discovery Experts, and construction attorney Chris Dunn analyze recent national trends in construction claims and discuss what

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