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 Amy Lerman, Jenny Nelson Carney, and Dan Fahey discuss the expiration of the PHE and the impact it will have on health care providers and organizations.   Recorded on February 22, 2023, ju ..read more

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 Robertson and EBG Advisor Dr. Joel Brill discuss coverage and reimbursement for direct access tests, as well as the related compliance factors that labs, product developers, and investors in the diagnost ..read more

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 Amy Dow, Bob Hearn, James Boiani, and Megan Robertson discuss the regulatory landscape governing direct access laboratory testin ..read more

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 industry faces as it attempts to make sense of, and comply, with that guidance.   Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc57.   Sub ..read more

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 Snyder, Kevin Malone, and Helaine Fingold 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 ..read more

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 Kate Heffernan, Marylana Helou, and Megan Robertson discuss how the changing state laws and regulations post-Dobbs may impact clinical research in different ways for dif ..read more

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: https ..read more

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, Spreeha Choudhury, and Jessika Tuazon discuss the impact of the Dobbs decision on pharmacies and pharmacists, including patient access to certain reproductive health or abortion-inducing ..read more

The past three years have been tumultuous in the health care construction economy, and the patterns in recent construction claims might surprise some. Which types of claims are popping up, in what regions are they appearing, and what types of facilities are involved? On this episode of our Owner's Outlook series, special guest Brett Lamb, co-founder and CEO of Construction Discovery Experts, and construction attorney Chris Dunn analyze recent national trends in construction claims and discuss what health care owners can expect moving forward. Visit our site for more information ..read more

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, Epstein Becker Green attorneys Jenny Nelson Carney, Stuart Gerson, Erin Sutton, and Dan Fahey discuss the post-Dobbs legislative landscape as well as the ongoing enforcement actions in the states ..read more