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- On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs). The court’s judgment vacates the agency’s controversial final rule of May 6 ...Thought Leaders in Health Law® Video Series
- As the dust from the COVID-19 public health emergency (PHE) continues to settle and the PHE-era flexibilities expire, telehealth providers are bracing themselves for the changes soon to come. These providers will inevitably face certain legal and regulatory complexities as federal and ...Thought Leaders in Health Law Video Series
- In today's complex and rapidly evolving health care landscape, navigating the path of expanding or selling a business requires a nuanced understanding of the intricate state and federal regulatory frameworks. With states increasingly imposing legislative oversight to safeguard ...Thought Leaders in Health Law® Video Series
The U.S. Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization to eliminate the federal constitutional right to abortion continues to alter the legal landscape across the country. On April 26, 2024, the U.S. Department of Health and Human Services (HHS ...
Thought Leaders in Health Law® Video Series- The landscape of laboratory testing in the United States is changing. On April 29, 2024, following more than a decade of discourse, the U.S. Food and Drug Administration (FDA, or the “Agency”) released its long-awaited “Medical Devices; Laboratory Developed Tests” final ...Thought Leaders in Health Law® Video Series
- In recent years, there has been unprecedented interest and activity regarding noncompetes and other restrictive covenants. Legislative, regulatory, and judicial authorities at both the state and federal levels have weighed in on the enforceability of such restrictive covenants in ...Thought Leaders in Health Law® Video Series
- Braidwood v. Becerra represents a significant legal challenge to the Affordable Care Act’s (ACA’s) preventive services coverage provision, which requires private health insurance to cover various clinical preventive services, including immunizations; services rated A or B by the ...Thought Leaders in Health Law Video Series
- The Inflation Reduction Act (IRA) introduces significant changes in prescription drug pricing, including the establishment of the Medicare Drug Price Negotiation Program and the Medicare Prescription Drug Inflation Rebate Program to control drug prices. The IRA includes a redesign of ...Thought Leaders in Health Law Video Series
- The U.S. Department of Justice (DOJ) collected $5.6 billion in False Claims Act recoveries in fiscal year (FY) 2021. That is over twice as much as 2020, and a record 90 percent of the total was collected from the health care and life sciences industries. DOJ’s health care recoveries in ...Thought Leaders in Health Law
- Is your organization ready for the No Surprises Act (NSA)? The law goes into effect January 1, 2022, and contains a new federal ban on surprise billing as well as new disclosure requirements. The NSA applies to certain payors, providers, facilities, and ancillary service entities that ...Thought Leaders in Health Law Video Series
- A physician group should conduct extensive “reverse due diligence” before entering into a private equity (PE) partnership. Important things to consider include: the PE firm’s financial ability to close the transaction with the physician group; the physicians’ comfort level ...Thought Leaders in Health Law Video Series
- Physician groups can keep their practice competitive – and on the “cutting edge” — by partnering with a private equity (PE) platform. The health care marketplace is evolving, and it takes substantial investment in infrastructure, such as IT, to stay ahead and continue be successful ...Thought Leaders in Health Law Video Series
- A private equity (PE) transaction can give a physicians group more room to focus on clinical care as they relinquish much of the administrative and practice management duties. A PE partnership allows physicians access to the PE platform’s seasoned and sophisticated management team and ...Thought Leaders in Health Law Video Series
- A private equity (PE) transaction can help physicians “hedge” the uncertain future of private medical practices in an ever-changing and regulated industry. Uncertainty in the industry includes changing reimbursement models, the prospect of “Medicare for All,” increasing ...Thought Leaders in Health Law Video Series
- Partnering with a private equity (PE) investor can help physicians monetize the value of their practice. Why treat your practice differently than other assets in your retirement portfolio? A PE transaction will provide an up-front cash payment and/or rollover equity in the PE platform ...Thought Leaders in Health Law Video Series
- Private equity (PE) investment in physician groups has steadily grown over the last several years, with 219 physician group deals being announced or closed last year. This trend leaves some groups wondering, is PE for us? There are five critical factors that physician groups should ...Thought Leaders in Health Law Video Series
- $3 billion recovered under the False Claims Act (“FCA”). That’s what the US Department of Justice (“DOJ”) reported collecting in FY2019. The health care and life sciences industries accounted for $2.6 billion of the total recoveries. That’s 87% of all FCA judgments and ...Thought Leaders in Health Law
In this Thought Leaders in Health Law® video, Neil Di Spirito, Alaap Shah, Jessika Tuazon, and Patricia Wagner, attorneys in the Health Care and Life Sciences practice, look at the Food and Drug Administration’s (FDA’s) guidance on the cybersecurity of medical devices and how the ...
Thought Leaders in Health Law Video SeriesIn this Thought Leaders in Health Law® video, Paulina Grabczak, Gail Javitt, and Yulian Shtern, attorneys in the Health Care and Life Sciences practice, are joined by Nathaniel Glasser, a Member of the Firm in the Employment, Labor & Workforce Management practice, to holistically look at ...
Thought Leaders in Health Law Video SeriesIn this Thought Leaders in Health Law® video, Paul DeCamp, Joshua J. Freemire, and Marc A. Mandelman, Members of the Firm, outline the key employment law concerns that health care companies should address during a transaction. This video looks at the following: The importance of ...
Thought Leaders in Health Law Video Series- Click above or watch via YouTube, Vimeo, MP4, or WMV. In this Thought Leaders in Health Law®video, Kathleen Premo, Mark Mosby, and Alaap Shah, Members of the Firm who have also served in various in-house counsel capacities, discuss methods for tackling the many demands that ...Thought Leaders in Health Law
- Click above or watch via YouTube, Vimeo, MP4, or WMV. In this Thought Leaders in Health Law® video, Leonard Lipsky, Joshua Freemire, and Victoria Vaskov Sheridan, attorneys in the Heath Care and Life Sciences practice, outline why due diligence is a critical step for investors ...Thought Leaders in Health Law
- Click above or watch via YouTube, Vimeo, MP4, or WMV. In this Thought Leaders in Health Law® video, Gail H. Javitt, Robert E. Wanerman, Joshua J. Freemire, and Alaap B. Shah, Members of the Firm in the Health Care and Life Sciences practice, discuss the legal implications and ...Thought Leaders in Health Law
- Click above or watch via YouTube, Vimeo, MP4, or WMV. In this Thought Leaders in Health Law® video, Jackie Selby, Kevin J. Malone, and Clifford E. Barnes, attorneys in the Health Care and Life Sciences practice, take a look at what the ongoing shift of Medicaid funding from the federal ...Thought Leaders in Health Law
- Click above or watch via YouTube, Vimeo, MP4, or WMV. The government recouped more than $2.4 billion from False Claims Act (FCA) settlements and judgments in Fiscal Year 2017 through cases that involved health care and life sciences entities. This Thought Leaders in Health ...Thought Leaders in Health Law Video Series
- Click above or watch via YouTube, Vimeo, MP4, or WMV. In this Thought Leaders in Health Law®video, Lynn Shapiro Snyder and Constance A. Wilkinson, Members of the Firm in the Health Care and Life Sciences practice, examine new business opportunities arising in 2018 as a result of ...Thought Leaders in Health Law
- Click above or watch via YouTube, Vimeo, MP4, or WMV. In this Thought Leaders in Health Law® video, Amy K. Dow, Gail H. Javitt, and Jessika Tuazon, attorneys in the Health Care and Life Sciences practice, discuss the legal and regulatory trends driving business opportunities in the ...Thought Leaders in Health Law
In this Thought Leaders in Health Law® video, Purvi B. Maniar, Kevin J. Ryan, and Lesley R. Yeung, attorneys in the Health Care and Life Sciences practice, examine the legal and regulatory implications of rapid change in the behavioral health care space. This video looks at the following ...
Thought Leaders in Health Law Video SeriesIn this Thought Leaders in Health Law® video, James A. Boiani, Theodora McCormick, and Jack Wenik, Members of the Firm in the Health Care and Life Sciences practice, discuss how the dietary supplement industry has been impacted by recent government enforcement and regulatory trends. This ...
Thought Leaders in Health Law Video SeriesIn this Thought Leaders in Health Law ® video, E. John Steren, Patricia M. Wagner, and Colin G. McCulloch, attorneys in the Health Care and Life Sciences practice, examine the evolution of antitrust issues in the health care industry and discuss what to keep top of mind in the current ...
Thought Leaders in Health Law Video SeriesIn this Thought Leaders in Health Law® video, John S. Linehan, Alan J. Arville, and Constance A. Wilkinson, attorneys in the Health Care and Life Sciences practice, discuss payment model changes, new regulatory approaches, and enforcement issues related to drug pricing and ...
Thought Leaders in Health Law Video Series- Patricia M. Wagner, Amy K. Dow, and Kim Tyrrell-Knott, Members of the Firm in the Health Care and Life Sciences practice, provide their perspectives on the complex regulatory environment that digital health companies need to consider when developing an effective business strategy. This ...Thought Leaders in Health Law Video Series
- David E. Matyas, Jason E. Christ, and Melissa L. Jampol, Members of the Firm in the Health Care and Life Sciences practice, examine what home care organizations can do as they face increasing government scrutiny and fraud and abuse enforcement. This video looks at the following: Recent civil ...Thought Leaders in Health Law Video Series
- Anjali N.C. Downs, Carrie Valiant, and Jack Wenik, Members of the Firm in the Health Care and Life Sciences practice, examine the government’s renewed focus on holding individual executives and members of boards of directors accountable for corporate wrongdoing. This video discusses ...Thought Leaders in Health Law Video Series
- Stuart M. Gerson; Ted Kennedy, Jr.; and Philo D. Hall (attorneys in the Health Care and Life Sciences practice of Epstein Becker Green); and Bob Atlas (President of EBG Advisors) examine the impact that the 2016 U.S. elections will have on trends and policies in the health care industry. ...Thought Leaders in Health Law Video Series
- Jackie Selbyand Philo D. Hall, attorneys in the Health Care and Life Sciences practice, and Douglas A. Hastings, Chair Emeritus of Epstein Becker Green, explore the health care industry’s shift from a fee-for-service payment system toward value-based payment in order to improve the ...Thought Leaders in Health Law Video Series
- Lynn Shapiro Snyder, Leslie V. Norwalk, and Helaine I. Fingold, attorneys in the Health Care and Life Sciences practice of Epstein Becker Green, and Thomas E. Hutchinson, a Strategic Advisor for EBG Advisors, Inc., discuss the best strategies to use when navigating the complex coding ...Thought Leaders in Health Law Video Series
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