Diagnosing Health Care Podcast

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-...

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 Sutto...

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...

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...

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 conside...

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...

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 Am...

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 Rob...

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 operation...

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...

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 Snyde...

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 at...

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...

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, Spre...

Following the Supreme Court's decision in  Dobbs v. Jackson Women's Health Organization , some states have banned abortion in all or most circumstances and many more have enacted new restrictions or enforced old ones. What must providers and health care leaders understand about this patchwork of laws, the ongoing enforcement activity, and protecting their organization's interests? On this episode,...

In celebration of the 50th episode of our  Diagnosing Health Care  podcast, we're looking at how the past 50 years of health law will impact health care in the next 50 years. On this episode, Epstein Becker Green attorneys Mark Lutes ; Lynn Shapiro Snyder ; Ted Kennedy, Jr. ; and Nivedita Patel talk about the past, present, and future solutions to a fundamental question: How can the United States...

While the COVID-19 pandemic seems to be moving into our rearview mirror, government investigations and enforcement actions targeting COVID-19-related fraud are just starting to heat up. What can businesses do to prevent or mitigate potential civil and criminal charges in this area? On this episode, Epstein Becker Green attorneys Melissa Jampol , Erica Sibley Bahnsen, and Rachel Weisblatt discuss C...

How have complaints of information blocking been submitted to the Office of the National Coordinator (ONC), and by whom? What does government enforcement action really look like? In this episode of our special series on interoperability, hear from ONC attorneys Cassie Weaver and Rachel Nelson . Cassie, Rachel, and Epstein Becker Green attorneys Allen Killworth and Nivedita Patel discuss how to bet...

For years, pharmacy advocates have urged policymakers to make changes to state scope of practice laws that would permit pharmacists to prescribe and administer certain tests and vaccines at the pharmacy. How has COVID-19 impacted these efforts? In this episode, special guest Will Chang , Chief Legal Officer of UpStream, and attorneys Richard Hughes and Kala Shankle discuss the history of pharmacis...

How is openEHR transforming the way health data is managed and stored across Europe? Will it soon disrupt the U.S. marketplace? In this episode of our special series on interoperability, hear from Alastair Allen , CTO of Better. Alastair and Epstein Becker Green attorneys Karen Mandelbaum and Nivedita Patel discuss how openEHR is already being applied in such places as London and France and how ex...

In the past decade, certified electronic health records (EHRs) have been instrumental in transforming medical records from paper to digital formats. What obstacles are currently preventing providers from sharing patient data with each other or patients from sharing health information from their personal devices with their providers? In this episode of our special series on interoperability, hear f...

What challenges are providers likely to face as the Occupational Safety and Health Administration (OSHA) prepares its permanent COVID-19 standard for health care workers? Attorneys Denise Dadika , Bob O'Hara , and Tim Murphy review the provisions of OSHA's temporary COVID-19 standard for health care workers, what's expected to change under the permanent rules, and the impact of the agency's curren...

What has contributed to the biotechnology industry's explosive growth over the last several years? In this episode, special guests Don and Lisa Drakeman , two former CEOs of biotech companies, reflect on what it takes to succeed, the regulatory challenges they have faced, and how current events are shaping the future of the industry. Joining our special guests are Epstein Becker Green attorneys Ro...

How does the U.S. Department of Justice (DOJ) intend to leverage its enforcement authority under the False Claims Act to advance DOJ's recently announced Civil Cyber-Fraud Initiative? Attorneys Stuart Gerson , Alaap Shah , and Bonnie Odom discuss what this initiative means for potential defendants and what companies can do to mitigate risk. The attorneys also consider whether the initiative makes...

The interoperability and information-blocking rules have imposed new regulations and requirements on health information exchanges (HIEs). How are HIEs responding to these new regulations in a space they have been in for decades? In this episode of our special series on interoperability, hear from Dan Paoletti , CEO of the Ohio Health Information Partnership. Dan and Epstein Becker Green attorneys...