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.
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Health Policy Update: Impact of the 2024 U.S. Elections
11/26/2024
Health Policy Update: Impact of the 2024 U.S. Elections
The recent 2024 elections resulted in a new Trump administration and a Republican-controlled House and Senate. From policymakers to stakeholders across the industry, everyone is wondering what health policy will look like in 2025 and beyond. On this episode, Epstein Becker Green attorneys , , , and discuss the results of the 2024 elections and their impact on the health policy space. What will a second Trump administration look like? How might the election results affect the health care policies addressed during Congress’s 2024 lame-duck session? Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Advancements of Artificial Intelligence in Health Care – One Year After White House Executive Order
10/31/2024
Advancements of Artificial Intelligence in Health Care – One Year After White House Executive Order
One year ago, on October 30, 2023, President Joe Biden signed an executive order laying the groundwork both for how federal agencies should responsibly incorporate artificial intelligence (AI) within their workflows and how each agency should regulate the use of AI in the industries it oversees. What has happened in the past year, and how might things change in the next? On this episode, Epstein Becker Green attorneys , , and reflect on what is new in health care AI as a result of the 2023 executive order and discuss what industry stakeholders should be doing to comply and prepare for future federal regulation of AI in health care. Article – HTI-1 final rule: Article – HTI-2 proposed rule: Webinar – New Final Regulation Prohibiting Algorithmic Discrimination by Health Care Providers and Payers: Webinar – Demystifying AI Tools in Health Care, An Introduction for Federal Policymakers: Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Workplace Violence in Health Care: Dissecting the Legal Landscape and Implications for Employers
09/12/2024
Workplace Violence in Health Care: Dissecting the Legal Landscape and Implications for Employers
Workplace violence in health care settings is on the rise, capturing the attention of both state and federal lawmakers. As awareness grows, so too does legal scrutiny and the push for new regulations and enforcement. In these seemingly critical times, what should health care employers be thinking about and incorporating into their comprehensive strategies to prevent and address workplace violence? On this episode, Epstein Becker Green attorneys , , and dissect the legal landscape surrounding health care workplace violence, examining the steps being taken at various levels of government and what they mean for health care providers and institutions. Join us as we explore the legal frameworks, emerging policies, and broader compliance implications for health care employers. Check out our on workplace violence laws in health care. Access the Hospital Association of Oregon’s Visit our site for related resources and email contact information: Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Navigating the Labyrinth of Private Equity Investments in Health Care
09/05/2024
Navigating the Labyrinth of Private Equity Investments in Health Care
The game has changed—are you positioned to adapt? Over the past 12 months, the federal government has been heavily regulating private investment in health care entities. Simultaneously, multiple states have enacted or introduced new laws restricting or requiring approval of such investments. The question arises: What do you do if you already have investments in these health care entities? On this episode, , Strategic Counsel at Epstein Becker Green (EBG), joins EBG attorneys , , and to discuss how health care entities, investors, and board members should be responding to an evolving political and regulatory environment that has increased the scrutiny of private investment in health care entities. Letter to Joint Agency RFI on Consolidation in Health Care Markets: Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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The DEA Is Knocking at Your Door . . . Are You Prepared?
08/01/2024
The DEA Is Knocking at Your Door . . . Are You Prepared?
Knock, knock! If the Drug Enforcement Administration (DEA) is already at your door, it may be too late. Enforcement is on the rise, and the microscope is fixed on controlled substances. What can industry stakeholders do to prevent penalties and protect themselves from DEA scrutiny? On this episode, Epstein Becker Green attorneys , , and discuss recent and pending updates to DEA rules and guidance, outline steps stakeholders can take to prepare for an inspection, and share tips on what to do when the DEA arrives. Visit our site for more information and related resources: Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs
07/25/2024
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs
Laboratories in the United States are facing a major regulatory landscape shift. The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory developed tests (LDTs). What does this mean for labs going forward? On this episode, Epstein Becker Green attorneys , , and lay out the new landscape, analyze existing and potential challenges, and identify key developments to watch for as this new regulatory era unfolds. Visit our site for more information and related resources: Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court
07/18/2024
Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court
In a recent landmark decision, the U.S. Supreme Court overruled the Chevron doctrine in the case of Loper Bright Enterprises v. Raimondo. This ruling has significant implications for employers and other entities in the health care and life sciences industries, as it changes the way courts are likely to interpret and apply regulations issued by federal agencies. On this episode, Epstein Becker Green attorneys , , , and analyze the fallout of this monumental decision, discuss what it means for entities seeking to challenge ambiguous statutes and regulations, and assess how to proceed from here. Visit our site for more information and related resources: Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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If Cannabis Is Reclassified, What Will Happen to the Marketplace?
06/20/2024
If Cannabis Is Reclassified, What Will Happen to the Marketplace?
Will the reclassification of marijuana from a Schedule I to a Schedule III drug disrupt the cannabis marketplace? What consequences must industry stakeholders consider if the Drug Enforcement Administration's proposal becomes a reality? On this episode, special guests , a New Jersey-licensed pharmacist, and , an accountant with expertise in representing cannabis operators across the United States, join Epstein Becker Green attorney to discuss the regulatory domino effect and tax implications related to this major potential change to the cannabis industry. Visit our site for more information and related resources: Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Unveiling Gender-Affirming Care: Why It Matters and What's at Stake
05/16/2024
Unveiling Gender-Affirming Care: Why It Matters and What's at Stake
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 , , and dissect gender-affirming care: what it is, what it isn't, and what is at stake for everyone involved. Visit our site for more information and related resources: Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Key Changes in Finalized Antitrust Merger Guidelines
04/11/2024
Key Changes in Finalized Antitrust Merger Guidelines
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 identifying the procedures and enforcement practices they will apply for evaluating potential mergers. What might these changes mean for hospitals, health systems, and other stakeholders in the health care industry? On this episode, we discuss some of the key changes in the finalized antitrust merger guidelines and what these guidelines mean for the agencies' approach to enforcement. Visit our site for more information and related resources: Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Health Equity: Behind the Buzzwords
12/14/2023
Health Equity: Behind the Buzzwords
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 advance health equity? On this episode, Epstein Becker Green attorneys , , and discuss the recent national focus on health equity, the actionable interventions behind the concept, and the responsibility of stakeholders in making care delivery more equitable. Visit our site for more information and related resources: Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Telehealth Post-Public Health Emergency: What to Expect in 2024
12/07/2023
Telehealth Post-Public Health Emergency: What to Expect in 2024
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, yet no two states are exactly alike in their approach to defining and regulating telehealth. On this episode, Epstein Becker Green attorneys , , and discuss emerging trends in state laws and regulations post-PHE as well as federal regulatory and enforcement developments that set the stage for states. Visit our site for more information and related resources: Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Antitrust Updates: Changes Affecting Merger Review and Enforcement in 2024 and Beyond
11/10/2023
Antitrust Updates: Changes Affecting Merger Review and Enforcement in 2024 and Beyond
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 stakeholders in the health care industry? On this episode, Epstein Becker Green attorneys , , , and dive into the latest developments in health care antitrust law and analyze the FTC’s and DOJ’s views on mergers in health care markets. Visit our site for more information and related resources: Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Dietary Supplements: Navigating the Regulatory Maze
11/02/2023
Dietary Supplements: Navigating the Regulatory Maze
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 , , , and discuss recent updates to the FDA and FTC guidelines as they apply to dietary supplement manufacturers, as well as new developments with respect to misbranding. Visit our site for more information and related resources: Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs
09/28/2023
Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs
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 , , and discuss licensing and operational considerations, as well as where the lab testing industry is headed. Visit our site for more information and related resources: Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now?
08/01/2023
Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now?
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 . Sylvia and Epstein Becker Green attorneys and discuss the recent updates on the quickly moving implementation of the drug pricing provisions under the IRA and the industry's response. Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Post-Dobbs: One Year Later
06/22/2023
Post-Dobbs: One Year Later
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 , , and examine how the Dobbs decision has impacted the legal landscape for patient access to abortion, discuss the challenges facing the health care industry, and explore how industries can manage their compliance efforts moving forward as the legal landscape continues to evolve. Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Managing Trade Secrets and Restrictive Covenants in Health Care M&A Deals
05/18/2023
Managing Trade Secrets and Restrictive Covenants in Health Care M&A Deals
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 Care and Spilling Secrets, Epstein Becker Green attorneys , , , and talk about the different types of health care M&A transactions and the importance of securing key employees post-closing. Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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The Legal Battle Over Mifepristone
05/09/2023
The Legal Battle Over Mifepristone
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 , , and analyze the ongoing legal battle over mifepristone and discuss implications for industry stakeholders, including drug manufacturers, distributors, providers, and patients. Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next?
05/04/2023
Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next?
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 , , and 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 implementation of the Medicare Drug Price Negotiation Program and the Medicare Prescription Drug Inflation Rebate Program under the IRA. Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Direct Access Laboratory Testing: Physician Orders and Specimen Collection
04/20/2023
Direct Access Laboratory Testing: Physician Orders and Specimen Collection
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, Epstein Becker Green attorneys Bob Hearn, Amy Lerman, and Megan Robertson discuss physician ordering and specimen collection considerations for direct access laboratory testing stakeholders. Stay tuned for the final episode of our special series on direct access laboratory testing. Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . The EMPLOYMENT LAW THIS WEEK® and DIAGNOSING HEALTH CARE podcasts are presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Legal and Regulatory Landscape for Psychedelics as Therapies
04/13/2023
Legal and Regulatory Landscape for Psychedelics as Therapies
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 , , and 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 States. Visit our site for related resources and email contact information: Subscribe for email notifications: Visit: . The EMPLOYMENT LAW THIS WEEK® and DIAGNOSING HEALTH CARE podcasts are presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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2023 Deal Cycle: Considerations for Transactions in Uncertain Economic Times
03/30/2023
2023 Deal Cycle: Considerations for Transactions in Uncertain Economic Times
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 , , and discuss how the changing economic climate has impacted the 2023 deal cycle and forecast the trends we expect to see this year. Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . The EMPLOYMENT LAW THIS WEEK® and DIAGNOSING HEALTH CARE podcasts are presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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The End of the Public Health Emergency – What’s to Come?
03/16/2023
The End of the Public Health Emergency – What’s to Come?
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 , , and discuss the expiration of the PHE and the impact it will have on health care providers and organizations. Recorded on February 22, 2023, just prior to the release of the Drug Enforcement Administration’s proposed rules. Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . The EMPLOYMENT LAW THIS WEEK® and DIAGNOSING HEALTH CARE podcasts are presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Direct Access Laboratory Testing: Reimbursement & Compliance
03/09/2023
Direct Access Laboratory Testing: Reimbursement & Compliance
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 and and EBG Advisor discuss coverage and reimbursement for direct access tests, as well as the related compliance factors that labs, product developers, and investors in the diagnostic testing industry should be aware of. Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . The EMPLOYMENT LAW THIS WEEK® and DIAGNOSING HEALTH CARE podcasts are presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Direct Access Laboratory Testing: Navigating the Regulatory Landscape
02/23/2023
Direct Access Laboratory Testing: Navigating the Regulatory Landscape
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 , , , and discuss the regulatory landscape governing direct access laboratory testing. Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . The EMPLOYMENT LAW THIS WEEK® and DIAGNOSING HEALTH CARE podcasts are presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Unpacking FDA's Final Clinical Decision Support Guidance
02/09/2023
Unpacking FDA's Final Clinical Decision Support Guidance
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 and 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 related resources and email contact information: . Subscribe for email notifications: . Visit: . The EMPLOYMENT LAW THIS WEEK® and DIAGNOSING HEALTH CARE podcasts are presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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The PACE Program: What Changes May Be Coming Soon?
02/02/2023
The PACE Program: What Changes May Be Coming Soon?
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 , , and explore the ins and outs of PACE, the changes in recent years that have made PACE available to for-profit companies, and the specifics of the provisions in the pending federal proposed rule. Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . The EMPLOYMENT LAW THIS WEEK® and DIAGNOSING HEALTH CARE podcasts are presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Post-Dobbs: Considerations for Clinical Trials and Research
01/26/2023
Post-Dobbs: Considerations for Clinical Trials and Research
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 , , and discuss how the changing state laws and regulations post-Dobbs may impact clinical research in different ways for different stakeholders. Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . The EMPLOYMENT LAW THIS WEEK® and DIAGNOSING HEALTH CARE podcasts are presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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2023 Health Policy Outlook
01/12/2023
2023 Health Policy Outlook
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 care issues may arise. Visit our site for related resources and email contact information: . Subscribe for email notifications: . Visit: . The EMPLOYMENT LAW THIS WEEK® and DIAGNOSING HEALTH CARE podcasts are presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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