The Ins and Outs of Medical Treatment in New Jersey Workers' Compensation Claims
The Presumption of Innocence Podcast: Episode 22 - Reclaiming Purpose: A Transformative Journey Through Addiction, Rehab and Prison
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 105: Sara Goldsby, Director, DAODAS
DE Under 3: Vaccine Mandate Updates, Contractor Unique Entity Identifiers, EEOC Nominations & A Reduced VEVRAA Hiring Benchmark
Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
Healthcare Headlines Episode 3 - Stay Ready: Trends in Healthcare False Claims Act Investigations
Workers' Compensation Academy: New Jersey Workers' Comp: Medical Marijuana and Opiates
Jones Day Talks Health Care: The Eliminating Kickbacks in Recovery Act
This Week in FCPA-Episode 77, the Home for the Holidays Edition
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to...more
The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more
The Situation: The U.S. Department of Justice ("DOJ") published its annual report regarding False Claims Act ("FCA") recoveries for fiscal year 2020 (ending September 2020) and announced its priorities for 2021. The...more
The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation for a “rare” disease: (1) if it affects less than 200,000 persons in the United States, or (2) if it “affects more than...more
On January 21, 2020, the Department of Justice (DOJ) announced a $3 million settlement with Patient Services, Inc. (PSI) to resolve allegations of False Claims Act (FCA) violations. The DOJ alleged that PSI enabled three...more
The Health and Human Services (HHS) Office of Inspector General (OIG) Work Plan describes audits, reviews and other work statutorily required or otherwise undertaken by the OIG. Monthly updates to the OIG Work Plan can be...more
Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more
On April 23, federal prosecutors announced the first-ever felony charges against a drug distributor — Rochester Drug Co-Operative, Inc. (RDC) — and two of its executives for illegally distributing opioid painkillers....more
Some very important and potentially game-changing legislation was recently passed. On Oct. 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (or EKRA) – a statute that potentially eliminates legal...more
Neal Gerber Eisenberg and Wolters Kluwer have teamed up to bring you NGE IP Focus, a quarterly newsletter dedicated to intellectual property-related legal decisions. ...more
Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues between user fee cycles. FDA regulates 20¢ of every U.S. consumer dollar...more
Notwithstanding its name, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 or the SUPPORT Act appears to regulate behavior that has nothing to do with...more
A massive bill intended to address the nation’s opioid crisis is about to become law—the House overwhelmingly voted in favor of the SUPPORT for Patients and Communities Act (H.R. 6) on Friday, September 28, 2018, and the...more
On August 16, 2018, in a joint statement by the US Department of Justice and the US Drug Enforcement Administration (DEA), the government proposed a reduction in the Aggregate Production Quotas (APQ) for certain controlled...more
On Thursday, August 9, 2018, Massachusetts Gov. Charlie Baker (R) signed H.4742, "An Act for prevention and access to appropriate care and treatment of addiction," which takes effect immediately. ...more
On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more
The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more