Your prescribed dose of health law news
On January 16, the U.S. Drug Enforcement Administration (DEA) announced three new telemedicine rules that extend prescribing flexibilities for controlled substances, following the expiration of temporary flexibilities granted during the COVID-19 pandemic. The new rules, which include both final and proposed regulations, aim to balance patient access with safeguards against misuse.
The rules apply only…
A recently issued federal court opinion confirmed that certain pre-COVID era prescribing restrictions are back in place. In July 2023, a nonprofit advocacy group, Community Oncology Alliance, filed suit against the U.S. Department of Health and Human Services (HHS) regarding provisions of the Stark Law. Stark prohibits physicians from referring Medicare and Medicaid patients to…
As previously discussed here, Johnson & Johnson (J&J) recently announced its intention to change its 340B Drug Pricing Program discount available to disproportionate share hospital (DSH) Covered Entities on purchases of STELARA and XARELTO. However, the Health Resources and Services Administration (HRSA) notified J&J that its rebate model was contrary to the 340B statute…
On August 23, Johnson & Johnson (J&J) announced changes to its 340B Drug Pricing Program discount available to disproportionate share hospital (DSH) Covered Entities on purchases of two of J&J’s most popular drugs, STELARA and XARELTO.
As of October 15, J&J will make a 340B discount on these drugs available through a rebate. According to…
On September 19, Rivkin Radler’s Jeff Kaiser will participate on a panel at Practising Law Institute’s “Life Sciences 2024: Navigating Legal Challenges in Drug and Device Industries” program in New York City.
Held at PLI’s NY Conference Center at 1177 Avenue of the Americas and also available to view online, the program will cover the…
The U.S. Department of Justice announced on July 24 that Admera Health LLC, a New Jersey-based biopharmaceutical research and clinical laboratory testing company, agreed to pay $5,389,648 to resolve kickback allegations brought by two whistleblowers under the False Claims Act (FCA).
Admera provides biopharmaceutical research services for healthcare institutions and provided clinical laboratory testing services…
On June 27, U.S. Attorney General Merrick Garland announced the results of a two-week nationwide law enforcement action by the Department of Justice (DOJ) in 32 federal districts against 193 defendants for their participation in a variety of healthcare fraud schemes. These federal enforcement actions also included the seizure of more than $230 million in…
Manishkumar Patel of Pelham Manor, NY recently pleaded guilty in connection with a healthcare fraud and kickback scheme involving the sale of fraudulent prescriptions to pharmacies, durable medical equipment suppliers, and laboratories, which then obtained payments from Medicare. The scheme resulted in $50 million in fraudulent claims from 2019-22.
Patel and a co-conspirator worked with…
Marc S. Ullman, of counsel to Rivkin Radler, wrote the March 28 article “FDA sends a message with two warning letters to Amazon” in Natural Products Insider.
In the article, Marc explains the importance of the FDA warning letters on homeopathic “supplements” and products that contain active pharmaceutical ingredients. Marc writes, “During the…
The U.S. Attorney’s Office for the District of New Jersey recently announced a $750,000 settlement with Sentynl Therapeutics Inc., a California-based specialty pharmaceutical company. The settlement resolved allegations that Sentynl improperly provided kickbacks to a physician to induce prescriptions of its opioid products in violation of the federal Anti-Kickback Statute (AKS).
The Government alleged that…
