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 James Boiani, Rob Wanerman, and Megan Robertson 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: http ..read more

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 George Breen, Stuart Gerson, Rob Wanerman, and Paul DeCamp analyze the fallout of this monumental decision, discuss what it means for entities seeking to challenge ambiguous statutes ..read more

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 Pierce Reisz, and Erin Sutton 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 resou ..read more

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 f ..read more

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 Jackie Selby, Kevin Malone, and Marjorie Scher discuss the recent national focus on health equity, the actionab ..read more

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 Amy Lerman, Audrey Davis, and Avery Schumac ..read more

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, we dive into the latest developments in health care antitrust law and analyze the FTC’s and DOJ’s views on mergers in health car ..read more

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 they apply to dietary supplement manufacturers, as well as new developments with respect to misbrand ..read more

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, James Boiani, and Megan Robertson discuss licensing and operational considerations, as well as where ..read more

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 implementation of the drug pricing provisions under the IRA and the industry's response. V ..read more