Diagnosing Health Care Podcast

Diagnosing Health Care Podcast

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.

Episodes

May 16, 2024 25 mins

Gender-affirming care has become the latest flashpoint in state legislatures and state and federal courts across the nation. States are divided, with some passing laws that seek to restrict access to gender-affirming care and others aiming to protect access. What is gender-affirming care? What risks does it pose to providers and patients? On this episode, Epstein Becker Green attorneys Jenny Nelson Carney, Lisa...

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After nearly two years of combined efforts from the Federal Trade Commission and the Antitrust Division of the Department of Justice, the agencies jointly issued much-anticipated merger guidelines id...

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December 14, 2023 19 mins

Under the Biden administration, the Centers for Medicare & Medicaid Services published a health equity framework that drastically changed the playing field for health plans and other risk-bearing entities. In the wake of these changes, how can health plans, accountable care organizations, and other similar stakeholders successfully create and administer social determinants of health interventions as a means to ...

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What trends in state laws and regulations have emerged in the post-public health emergency (PHE) era, and how do these changes impact telehealth stakeholders? At the federal level, many telehealth-related flexibilities have been extended through December 31, 2024, whereas, at the state level, there are wide variations in approach. Many states have continued to push the boundaries of existing telehealth policies...

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From wholesale revisions of the merger guidelines to significant amendments to the Hart-Scott-Rodino premerger notification forms, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) have proposed significant changes that, if adopted, will have profound effects on merger review and enforcement for the foreseeable future. What might these changes mean for hospitals, health systems, and other s...

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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...

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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 ...

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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 ...

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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 Be...

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June 22, 2023 28 mins

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 attor...

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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 indu...

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May 9, 2023 39 mins

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,...

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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, a...

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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 f...

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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

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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 B...

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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, Eps...

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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 Beck...

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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 asp...

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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


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