The U.S. Department of Health & Human Services Office of Civil Rights (OCR) announced on April 11, 2023 that the Notifications of Enforcement Discretions issued during the COVID-19 Public Health Emergency (PHE) would be expiring at 11:59 p.m. on May 11, 2023 due to the expiration of the PHE. A copy of the notice of
In August 2022, President Biden signed into law the Inflation Reduction Act. The Act’s key provisions include the ability of the federal government to negotiate certain prescription drug pricing. Specifically, the law created a program that allows the federal government to negotiate prices for a limited number of high-cost single-source drugs (lacking generic and/or biosimilar
In light of the New Jersey Appellate Division’s recent decision in County of Passaic v. Horizon Healthcare Services affirming the validity of a commercial arbitration agreement that did not contain a jury waiver, contracting entities including those in the healthcare sector need to approach language differently depending on whether they are dealing with a consumer
On February 10, 2023, the United States National Security Agency (NSA), the U.S. Federal Bureau of Investigation (FBI), the U.S. Cybersecurity and Infrastructure Security Agency (CISA), the U.S. Department of Health and Human Services (HHS), the Republic of Korea (ROK) National Intelligence Service (NIS), and the ROK Defense Security Agency (DSA) issued a joint Cybersecurity
Providers practicing in New York State who are enrolled in Medicaid should strongly consider revisiting their compliance programs following the recent issuance of new requirements by the New York State Office of the Medical Inspector General (OMIG).
On December 28, 2022, the OMIG issued new regulations (18 NYCRR 521-1.1, et seq.) requiring Medicaid-enrolled providers practicing
As discussed in this prior blog post, beginning in 2018 the U.S. Department of Health and Human Services (HHS) reduced reimbursement rates for Medicare prescription drugs to 340B hospitals by nearly thirty percent. The American Hospital Association (AHA) filed suit, and on June 15, 2022 the U.S. Supreme Court ruled that the cuts imposed
As discussed in this week’s Client Alert by our partner Alan S. Pralgever, New Jersey Governor Phil Murphy recently signed into law a bill (A-4768) that sets April 10, 2023, as the new effective date for long awaited amendments to the NJ WARN Act. These changes have far-reaching implications for New Jersey employers, including
As reported this past week by GovInfoSecurity, the Consolidated Appropriations Act of 2023, signed into law in late December 2022, included a key provision to help ensure the cybersecurity of medical devices by their manufacturers. GovInfoSecurity interviewed Dr. Suzanne Schwartz, director of the FDA’s Office of Strategic Partnerships and Technology Innovation, Center for Devices
The United States District Court’s 2021 ruling in Milton S. Hershey Medical Center v. Becerra is one example of a successful legal challenge to federal agency action, but a number of more recent cases reaffirm that lower federal courts may not hesitate to overturn agency action deemed outside the bounds of the agency’s legislative authority.
Although the Hospital Price Transparency Rule – which requires hospitals to make public a comprehensive list of charges for items and services – has been in effect for almost two years, the Congressional House Committee on Energy and Commerce advises that hundreds of warning letters and requests for civil monetary penalties to hospitals that are