Healthcare Enterprise Risk Management
Hospice Insights Podcast - Still Number One: Healthcare Fraud Remains Central in DOJ’s White Collar Enforcement Plan
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Podcast: Addressing Patient Complaints About Privacy Violations
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Podcast - Navigating the New Landscape of Private Equity in Healthcare
Medicaid Cuts: Potential Challenges and Legal Implications for Long-Term Care Facilities — Assisted Living and the Law Podcast
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Podcast - What Healthcare Providers Should Be Telling Students and Interns About HIPAA and Snooping
Podcast - Innovations and Insights in the Palliative Care Space
Managing Sanctions Compliance
Hospice Insights Podcast - Hospice Audit Updates: David Beats Goliath
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
Top Healthcare Compliance Priorities for 2025
ADA Compliance for Medical and Dental Practices: Responding to Inquiries and Investigations
Podcast - Who Owns Your DNA? Lessons Learned from 23andMe
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
As the song goes, the Food and Drug Administration’s (“FDA’s”) 2024 Final Rule regulating laboratory-developed tests (“LDTs”) as medical devices (“Final Rule”), is not merely dead—it’s really most sincerely dead....more
On March 24, Virginia Governor Glenn Youngkin signed into law SB 754 (Act), which amends the Virginia Consumer Protection Act (VCPA) to prohibit entities from collecting, disclosing, selling, or disseminating reproductive or...more
“ERISA, you’ll need a lawyer for that.” Our practice group’s tagline is meant to be a shorthand for the alphabet soup of laws that apply to employee benefits, including the Employee Retirement Income Security Act (ERISA)....more
In Janssen Pharmaceuticals, Inc. v. Mylan Laboratories., the United States Court of Appeals for the Federal Circuit affirmed a district court ruling that a pharmaceutical dosing claim limitation was nonobvious despite prior...more
On May 15, 2025, the Departments of Labor, Health and Human Services, and Treasury (the “Departments”) issued a statement of non-enforcement (the “Statement”) announcing that they will not enforce the 2024 Final Rule under...more
Federal Circuit reshapes foundational requirements for viability of a case in the ITC - Pharmaceutical and life sciences companies have historically been rare participants before the International Trade Commission (ITC) – in...more
United Therapeutics Corp. (UTC) and Liquidia Technologies Inc. have been battling for close to a decade over their respective inhaled formulations of treprostinil (UTC's Tyvaso®, Liquidia's Yutrepia™) for treatment of...more
Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision to vacate and set aside the agency’s final rule on the regulation of laboratory...more
Hello again. Below are summaries from a variety of published Fifth Circuit cases from April 2025, along with a late addition from March. One benefit of releasing the April summaries in early June is that you get the Federal...more
On May 29, 2025, the Department of Health and Human Services (“HHS”) rescinded its July 11, 2022 guidance (Ref. QSO-22-22-Hospitals) (the “2022 Guidance”) clarifying how the Emergency Medical Treatment and Labor Act of 1965...more
FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more
The White House’s recent release of the Make America Healthy Again (MAHA) Report marks a significant moment in the national conversation around children’s health and environmental exposure. Published on May 22, 2025, by the...more
On May 6, 2025, with almost no discernible press or public announcements, the Dental Trade Alliance (DTA) – a trade association of dental suppliers and service providers – issued a revised and restated U.S. Code of Ethics...more
Oregon is on the verge of passing a bill that would block private-equity ownership in healthcare practices. If passed, this measure would be the strictest ban on the corporate practice of medicine in the nation....more
The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the second of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding digital...more
As expected, the lawsuits have commenced following the enactment of the Arkansas legislation prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. Michigan has filed its...more
On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...more
Patent claims reciting compounds where at least one group of a compound genus is defined by its function are common. For example, familiar claim terms such as “chelating moiety,” “linker,” and “binding moiety” describe a...more
On May 22, 2025, the House passed H.R. 1, the One Big Beautiful Bill Act (the Bill), its budget reconciliation legislation that upheld most of the Medicaid-related provisions originally approved by the House Energy and...more
Shortly following its announcement of sweeping changes to RADV audits, CMS shared industry guidance last week regarding upcoming deadlines for the submission of risk adjustment data corrections in advance of RADV sampling....more
The development of innovative pharmaceuticals targeting refractory mental health conditions has stagnated for decades. In recent years, however, psychedelics have garnered scientific and public attention for their potential...more
The State of New York Supreme Court/County of Albany (“Court”) addressed in a May 6th Order whether the New York State Department of Health (“DOH”) has the authority to issue Watershed Rules and Regulations (“Rules”) to...more
On June 3, 2025, the Trump administration announced (the Announcement) that it would no longer follow Biden-era guidance (the Guidance) that directed hospitals to provide emergency abortions to pregnant women in emergency...more
What do a global sportswear giant and a prestigious medical center have in common? Apparently, a shared struggle defending data breach lawsuits for breaches of sensitive personal information caused by third-party vendors....more
How much insurance does my organization need? This conundrum impacts policyholders from small businesses needing single policies to Fortune 500 companies placing complex, multimillion-dollar insurance towers. For owners and...more
