Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...more
Previously published in Healthcare News and Healthcare Michigan - On Sept. 9, 2024, the Departments of Health and Human Services, Labor, and the Treasury (collectively “the Departments”) released final rules strengthening and...more
On April 4, 2024, a final rule published on February 2, 2024 (the Final Rule) went into effect that concerns medication for the treatment of opioid use disorder. The Final Rule, published by the Substance Abuse and Mental...more
In its August 15, 2023, Enforcement listserv notice, the U. S. Department of Health and Human Services Office of Inspector General (“OIG”) published its Work Plan Updates for August. This article will highlight three of the...more
Recognizing the urgent need to increase access to mental health and substance use services for young people, Congress is taking significant legislative steps to strengthen the federal government’s response to the nationwide...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
In carrying out the mandate of the Public Health Service Act and in an effort to address the country’s drug crisis, the Department of Health and Human Services (“HHS”) has made $350 million available for grant funding to...more
The 21st Century Cures Act (Act), enacted in December 2016, has received widespread coverage for funding biomedical research and streamlining the drug approval process. The Act also includes the Helping Families in Mental...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...more