Diagnosing Health Care Podcast

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.

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 over...

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 strategi...

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 invest...

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 pr...

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?

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 ...

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?

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...

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...

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 ...

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...

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...

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...

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 ...

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.

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...

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...

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,...