Health Law Advisor

In this episode of the Diagnosing Health Care Podcast:  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 Trish ...

In this episode of the Diagnosing Health Care Podcast: 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 ...

In this episode of the Diagnosing Health Care Podcast:  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 ...

In this episode of the Diagnosing Health Care Podcast:  The impacts of climate volatility, cybersecurity threats, artificial intelligence, and building information modeling and construction technology have increased pressure on major construction projects on top of labor availability and supply chain adversity. 

If your approach to delivering construction is the same as it was in early 2020, you’re probably inviting more risk to your project than you want.

As part of our Owner’s Outlook series, special guest Alanna Klein, Product Director of Construction and ...

In this episode of the Diagnosing Health Care Podcast:  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?

Epstein Becker Green attorneys Amy Dow, Erin Sutton, and Jessika Tuazon 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.

In this episode of the 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-intensive industry like health care?

In this episode of the Diagnosing Health Care Podcast:  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.

In this episode of the Diagnosing Health Care Podcast:  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?

In this episode of the Diagnosing Health Care Podcast:  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?

In this episode of the Diagnosing Health Care Podcast:  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?

In this episode of the Diagnosing Health Care Podcast:  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?

In this episode of the Diagnosing Health Care Podcast:  When analyzing the life cycle 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 (DATs) pose when it comes to reimbursement and related compliance requirements?

In this episode of the Diagnosing Health Care Podcast:  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.

In this episode of the Diagnosing Health Care Podcast:   The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software.

How has this document caused confusion for industry? How can companies respond?

In this episode of the Diagnosing Health Care Podcast:   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, hear from special guest Wendy Edwards, Director of Internal Operations at BluePeak Advisors.

In this episode of the Diagnosing Health Care Podcast:   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 different stakeholders.

In this episode of the Diagnosing Health Care Podcast:   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?

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.

In this episode of the Diagnosing Health Care Podcast:  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?

In this episode of the Diagnosing Health Care Podcast:  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, hear from special guest Brett Lamb, co-founder and CEO of Construction Discovery Experts.

In this episode of the Diagnosing Health Care Podcast:  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.

In this episode of the Diagnosing Health Care Podcast:  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?

In this episode of the Diagnosing Health Care Podcast:  Since the beginning of 2022, prices for construction services and materials have seen significant increases. How have these increases impacted the advancement of both new and ongoing health care construction projects?

On this episode of our Owner’s Outlook series, hear from special guest Clint Russell, Vice President of Capital Deployment – Construction and Equipment at HCA Healthcare.

Now on the Diagnosing Health Care Podcast:  The COVID-19 pandemic kicked off a pivot in health care construction and design, and acute care facilities have been rapidly renovating to adapt their spaces to evolving public health care needs.

From the Diagnosing Health Care Podcast:  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.

In this episode of the Diagnosing Health Care Podcast:  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?

Hear from special guest Will Chang, Chief Legal Officer of UpStream.

From the Diagnosing Health Care Podcast:  Over the last 12–24 months, Critical Access Hospitals (CAHs) have seen steep cost escalation in their expansion and renovation plans, with expense increases exceeding 10 percent. Combined with nationwide staffing shortages, CAHs are at a crossroads as to how to proceed.

On this episode of our Owner’s Outlook series, hear from special guest Eric Shell, Chairman of Stroudwater Associates, a national advisory firm that designs solutions for rural and community hospitals.

Featured on the Diagnosing Health Care Podcast:  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.

In this episode of the Diagnosing Health Care Podcast:  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 from Tomaž Gornik, founder and CEO of Better.

In this episode of the Diagnosing Health Care Podcast:  Staffing challenges and cost inflation are seriously impacting health care construction as well as other sectors of the U.S. construction economy.

In this episode of the Diagnosing Health Care Podcast:  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 and what’s expected to change under the permanent rules. They also discuss how the agency’s current enforcement push is impacting health care providers.

In this episode of the Diagnosing Health Care Podcast:  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.

In this episode of the Diagnosing Health Care Podcast:  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?

In this episode of the Diagnosing Health Care Podcast:  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.

New from the Diagnosing Health Care Podcast:  One of the long-term goals of the interoperability and information-blocking rules is to give health care providers a much more comprehensive view of a patient’s entire continuum of care.

In this episode of the Diagnosing Health Care Podcast:  The Supreme Court recently upheld the Centers for Medicare and Medicaid Services (CMS) vaccine mandate, which requires recipients of federal Medicare and Medicaid funding to ensure that employees, including third- party contractors, are vaccinated against COVID-19. The Court’s decision has clear implications for owners of health care facilities and their contractors with active construction work in 2022 and beyond.

In this episode of the Diagnosing Health Care Podcast:  This term, the Supreme Court of the United States is set to rule in a Medicare reimbursement case that has sparked a fresh look at the historical deference often granted to agencies and whether it should remain, be modified, or even be overruled.

Attorneys Stuart Gerson, Robert Wanerman, and Megan Robertson discuss why Chevron deference matters to health care industry stakeholders and what aspects of deference arguments should be in focus as these cases progress.

The Diagnosing Health Care podcast series examines the ...

In this episode of the Diagnosing Health Care Podcast:  The Biden administration has released a series of rules and guidance to implement the No Surprises Act, which went into effect on January 1. All providers and facilities must now provide a good faith estimate to uninsured and self-pay patients scheduling appointments for services or upon request.

In this episode of the Diagnosing Health Care Podcast:  The No Surprises Act (NSA) will go into effect on January 1, 2022. Since our last episode on the topic, the federal government has issued additional interim final rules and guidance to implement the NSA, including the second interim final rule. In addition to describing how the NSA interacts with the plan external review procedures, the second interim final rule describes the independent dispute resolution (IDR) process and how the IDR’s determination is made.

Attorneys Helaine Fingold, Lesley Yeung, and Alexis Boaz dive into how these changes impact entities subject to the NSA’s balance billing prohibitions.

In this episode of the Diagnosing Health Care Podcast:  We’re beginning to see how mergers and acquisitions in the hospital industry are being impacted by President Biden’s executive order promoting competition in the American economy. The Federal Trade Commission recently announced policy changes, and the Department of Justice has been asked to consider policy changes, that boards of directors and C-suite officers must take into account when weighing transactions.

Special guest Dr. Subramaniam (Subbu) Ramanarayanan, Managing Director at NERA Economic Consulting ...

As featured on the Diagnosing Health Care Podcast:  As 2021 nears a close, acute care hospitals and health systems are facing a host of financial, regulatory, and legislative challenges. In this special episode of Diagnosing Health Care, Rick Pollack, President and CEO of the American Hospital Association, and Epstein Becker Green’s Ted Kennedy, Jr., discuss the ways in which the industry is working with the Biden administration and Congress to shape policy around critical issues, such as surprise billing, coverage expansion, value-based care, and telehealth.

Rick ...

In this episode of the Diagnosing Health Care Podcast:  On December 27, 2020, President Trump signed into law the No Surprises Act as part of the $2.3 billion Consolidated Appropriations Act. Recently, the Biden administration issued its first interim final rule in order to implement this act, which will go into effect on January 1, 2022. While the goal is to protect patients from surprise billing, the law will also impose significant compliance burdens on plans, providers, and facilities.

Epstein Becker Green attorneys Helaine Fingold, Bob Hearn, and Alexis ...

In this episode of the Diagnosing Health Care Podcast:  Although the COVID-19 pandemic exposed cybersecurity vulnerabilities across sectors, it has particularly challenged the resilience of information systems for health care and life sciences companies. Because ransomware attacks have the potential to cripple access to important data, expose patient health records, and shut down machinery and life-saving equipment, it's no surprise that health care executives continue to lose sleep thinking about potential ransomware or other similar malicious attacks.

Epstein Becker ...

In this episode of the Diagnosing Health Care Podcast:  The Departments of Labor, Health and Human Services, and the Treasury jointly released a set of frequently asked questions (“FAQs”) related to recent changes made to the Mental Health Parity and Addiction Equity Act effective as of February 10, 2021, and enacted by the Consolidated Appropriations Act at the end of 2020. Accordingly, health plans and insurers must ensure that they understand, and are prepared to provide regulators with documentation of their compliance with, parity requirements on at least a small ...

In this episode of the Diagnosing Health Care Podcast:  Federal and state cannabis regulation and enforcement appear to be moving in different directions. While the Food and Drug Administration (“FDA”) has broadened its net to target businesses making claims that their products can treat specific conditions, a growing number of states have passed bills that, among other things, legalize adult-use cannabis.

Epstein Becker Green attorneys Delia Deschaine, Nathaniel Glasser, and Megan Robertson discuss how developments in 2021 impact the cannabis industry and why ...

In this episode of the Diagnosing Health Care Podcast:  The vaccine passport has been a major topic of discussion as businesses and governments consider how to balance privacy and safety through the rollout of the COVID-19 vaccine. Epstein Becker Green attorneys Patricia Wagner, Alaap Shah, and Jessika Tuazon discuss the privacy and security concerns companies must weigh as they consider developing or implementing vaccine passports, such as the collection and use of an individual's personal health information. As state governments and the private sector take the ...

In this episode of the Diagnosing Health Care Podcast:  Since the start of the COVID-19 pandemic, many jurisdictions have enacted protections from COVID-19-related liability claims through legislation and executive orders. These liability shields, however, may give health care businesses a false sense of security and offer little protection when it comes to employment claims.

Epstein Becker Green attorneys Denise Merna Dadika, Gregory Keating, and Elena Quattrone discuss the unintended liability consequences health care employers must consider as they ...

In this episode of the Diagnosing Health Care Podcast: Since the start of the COVID-19 pandemic, many jurisdictions have enacted protections from COVID-19-related liability claims through legislation and executive orders. These liability shields, however, may give health care businesses a false sense of security and offer little protection when it comes to employment claims.

Epstein Becker Green attorneys Denise Merna Dadika, Gregory Keating, and Elena Quattrone discuss the unintended liability consequences health care employers must consider as they ...

In this episode of the Diagnosing Health Care Podcast:  The Centers for Medicare & Medicaid Services ("CMS") and the Office of Inspector General ("OIG") of the Department of Health and Human Services have at last published their long-awaited companion final rules advancing value-based care. The rules present significant changes to the regulatory framework of the federal physician self-referral law (commonly referred to as the “Stark Law”) and to the federal health care program’s Anti-Kickback Statute, or “AKS.”

Epstein Becker Green attorneys Anjali ...

New from the Diagnosing Health Care Podcast:  The Biden administration has invoked the Defense Production Act ("DPA") to speed up the production of vaccines and increase the domestic production of COVID-19 tests, personal protective equipment (or “PPE”), and other essential supplies. Epstein Becker Green attorneys Neil Di Spirito, Constance Wilkinson, and Bonnie Odom discuss the administration's reliance on the DPA as it continues to operationalize its pandemic response, and the challenges these actions are likely to present for medical product suppliers.

This Diagnosing Health Care Podcast episode dives into the growth of physician practices accepting risk-based payments from health plans and examines why these practices are attractive to investors. Special guest Jason Madden, Managing Director at Accordion, and Epstein Becker Green attorneys Joshua Freemire, Jason Christ, and Tim Murphy, discuss the health regulatory considerations investors must assess when evaluating investment opportunities with physician practices accepting risk-based payments.

To supplement the issues discussed in this ...

In this episode of the Diagnosing Health Care Podcast, dive into the Biden Administration's first 100 days in office and the potential executive orders, regulations, and new legislation with noteworthy health care policy implications.

Epstein Becker Green attorneys Ted Kennedy, Philo Hall, and Paulina Grabczak discuss President Biden’s priorities, including his COVID-19 response plan, and examines which "midnight rules" put in place by the Trump Administration could be intercepted or retained.

The Diagnosing Health Care podcast series examines the business ...

This Diagnosing Health Care episode examines the fraud and abuse enforcement landscape in the telehealth space and considers ways telehealth providers can mitigate their enforcement risks as they move into the new year. Hear how the uptick in enforcement warrants close consideration by telehealth providers, especially those that are new to the space and have not yet built their compliance infrastructures.

The episode features Epstein Becker Green attorneys Amy Lerman, Melissa Jampol, and Bonnie Scott.

The Diagnosing Health Care podcast series examines the business ...