The U.S. Supreme Court’s holding in Dobbs v. Jackson Women’s Health Organization has had a seismic impact on the landscape of U.S. healthcare. Among other effects, it has created new friction between states. With stark...more
The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more
This year, the federal government has made significant changes to longstanding health care privacy rules, while state lawmakers continue to enact privacy restrictions on consumer health data. These reforms modify legal...more
Marijuana is currently classified as a Schedule I drug under the Controlled Substances Act (“CSA”), defined as a substance having “no currently accepted medical use” and “a high potential for abuse.” Other Schedule I...more
On January 25, 2024, HHS Office for Civil Rights (OCR) issued guidance and responses to frequently asked questions regarding nondiscrimination regulations related to patient visitation. Hospitals, long term care facilities,...more
Medicare Advantage Organizations and Part D sponsors have a responsibility to ensure they offer and provide their members and potential enrollees with content and materials in alternate languages or accessible formats for...more
In a Notice of Proposed Rulemaking published December 2, 2022 (the Proposed Rule), the United States Department of Health and Human Services (HHS) proposed long-awaited changes to the regulations protecting the...more
Enrolling in such a CMS-sponsored innovation model now has an added benefit: a new Anti-Kickback Statute (AKS) safe harbor. ...In its mission to reward value over volume, the Centers for Medicare & Medicaid Services’ (CMS)...more
On Jan. 5, 2021, the President signed into law H.R. 7898, which provides even more incentive for Health Insurance Portability and Accountability Act (HIPAA)-covered entities and business associates to develop robust security...more
Advocates for healthcare patients, providers, payors and privacy professionals received good news on Thursday, December 10, 2020 with the announcement of long-awaited and debated proposed amendments to the complex Health...more
At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more
On November 13, 2017, the U.S. Department of Transportation (DOT) published a final rule making significant changes to 49 Code of Federal Regulations Part 40, which affects employers administering drug tests in the...more