Innovation in Compliance: Unpacking Healthcare Compliance with Maria Villanueva
False Claims Act Insights - Physician, Refer Thyself: How Stark Law and FCA Intersect
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 190: Healthcare Tech and Human Resources with Shannon Frazier, HR Executive Director at Lenovo
Video: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – Thought Leaders in Health Law
Greetings and Felicitations: The Future of Healthcare…Is Now: Part 3 – The Specifics of Managing Obesity
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 153: William Kenley, CEO, and Juana Slade, Chief Diversity Officer and Director of Language Services, AnMed Health
Greetings and Felicitations: The Future of Healthcare…Is Now: Part 2- Revolutionizing Healthcare: Personalized Medicine
Private Equity VS Real Estate Transactions | #6 What’s the Best Order to Sell?
Episode 152: Matt Littlejohn, CEO, MUSC Health Midlands
Private Equity VS Real Estate Transactions | #4 Optimizing Total Asset Value
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 151: Erin Ford, EVP & COO, and David Stefanich, Board Chair, SCBIO
Private Equity VS Real Estate Transactions | #3 Real Estate Valuations Explained
AGG Talks: Home Health & Hospice - Reimbursement Audits and Appeals
Podcast - Counsel That Cares - The Value of Value-Based Cancer Care
Episode 150 - Jane Pine Wood, Senior Vice President & Chief Legal Officer, BioReference
Podcast - The Latest on Antitrust and Non-Compete Agreements in Healthcare
Strategies to Manage Costs of Medical Care in a PA Workers’ Compensation Claim
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 149: Patrick Goodwill, CEO, Magnetic Insight
Podcast - Noteworthy Value-Based Care Mergers and Acquisitions Transactions
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 146: Ann Lewis, CEO, CareSouth
On July 19, Change Healthcare Ince. filed a breach report with HHS Office for Civil Rights (OCR) concerning its mammoth ransomware attack and breach. The organization’s breach report to OCR identifies just 500 individuals as...more
The recent Supreme Court decisions of SEC v. Jarkesy and Loper Bright Enterprises v. Raimondo have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act (“DSCSA”) as...more
In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more
Every year, the New Jersey legislature passes statutes that impact healthcare beyond rate increases under the Medicaid program. Last year was no different, and the discussion below highlights some of those statutes, such as...more
In an effort to enhance collaboration, the Indian Pharmaceutical Alliance (IPA) recently proposed that a more formal preferred partnership between the U.S. and India can not only lower drug prices in the U.S. but can improve...more
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
What do private equity and growth capital investors look for when adding new companies to their portfolio, and what strategies do they apply to help those companies optimize capital? Procopio Partner and Mergers &...more
This is the sixth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more
On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida’s proposal under the Section 804 Importation Program (SIP) for a period of two years. FDA’s action marks the first time a state drug...more
There is a wealth of dry powder to spend but 2023 has seen M&A deal activity hampered by rising costs of debt, unstable markets, supply chain issues, general political uncertainty, and fear of global recession. So, what does...more
Earlier this month, the American Society of Pharmacy Law hosted its annual conference in San Antonio, TX. This gathering of industry leaders provided a unique opportunity to delve into the ever-evolving landscape of pharmacy...more
News Briefs - FTC Aims to Take Action on Non-Competes, M&A Enforcement - Healthcare lobbying organizations' efforts to carve out industry-specific exemptions in recently proposed Federal Trade Commission policies are...more
With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more
In the hyper-connected era of smart manufacturing, accelerated by “Industry 4.0,” the manufacturing sector is undergoing a digital revolution. By leveraging technologies such as advanced automation, artificial intelligence,...more
Although 340B-participating covered entities likely don’t need the reminder, numerous manufacturers continue to significantly restrict 340B pricing available via traditional “bill to/ship to” contract pharmacy models, with...more
The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into the market. One of these measures is the...more
The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30th pertaining to the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”). ...more
At a global level, the decarbonization of the health care sector has been coordinated by the World Health Organization (WHO) COP26 Health Programme, launched at the COP26 climate summit in November 2021. Under this program,...more
With COVID diagnoses spiking across the United States this summer, we cannot yet claim that the pandemic is behind us. In fact, we are still experiencing residual medical device and equipment shortages, which has caused...more
The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more
The Big Picture - Congressional Overview - American voters delivered a decidedly mixed message to Washington on Tuesday, seemingly handing Republicans narrow control of the U.S. House of Representatives and a nominal check...more
US de-SPAC M&A deal value has contracted significantly during the first half of 2022, sliding from US$231.31 billion during the buoyant H1 2021 period to just US$26.29 billion for H1 2022. A wider M&A slowdown as a result of...more
On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more
US De-SPAC M&A Commentary - US De-SPAC M&A deal value totaled US$8.13 billion from 16 De-SPAC deals in Q1 2022. This was significantly lower than the record US$155.43 billion of De-SPAC deal value from 81 deals reported at...more
Division Y – Cyber Incident Reporting for Critical Infrastructure Act of 2022 was signed into law by President Biden on March 15. Highlights of the Act include: ...more