In our May 2024 Healthcare Alert, we discussed a final rule published by the US Food and Drug Administration (FDA) amending its regulations to include in vitro diagnostic products (IVDs), even those manufactured in a...more
4/24/2025
/ Administrative Procedure Act ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Hospitals ,
Judicial Authority ,
Laboratory Developed Tests ,
Loper Bright Enterprises v Raimondo ,
Medical Devices ,
Regulatory Authority ,
Statutory Interpretation ,
Vacated
In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
Compared to previous years, the New Jersey Legislature passed a limited number of statutes impacting health care in 2024. It was a slow start to 2024, but activity picked up in the last six months of the calendar year. Once...more
1/15/2025
/ Background Checks ,
Debt Collection ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Licensing Boards ,
Medicaid ,
Medical Debt ,
New Jersey ,
New Legislation ,
Pharmacies ,
Reproductive Healthcare Issues ,
State Legislatures ,
Telehealth ,
Telemedicine ,
Vaccinations
In connection with certain mergers and acquisitions, the FTC and the Antitrust Division of the US Department of Justice review information provided by parties about proposed transactions reportable under the Hart-Scott-Rodino...more
The Centers for Medicare & Medicaid Services (CMS) has adopted an age-friendly quality hospital measure in its most recent final rule addressing prospective payment systems, policy changes, and quality program requirements...more
On July 31, 2024, the Department of Health and Human Services (HHS) final rule, 89 FR 54662, establishing disincentives for certain healthcare providers that have committed information blocking, will become effective. This...more
Through its recent decision in Loper Bright Enterprises v. Raimondo, No. 22-451 (S. Ct. June 28, 2024), the US Supreme Court overturned the landmark decision in Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc.,...more
7/18/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Federal Bans ,
Federal Trade Commission (FTC) ,
Government Agencies ,
Healthcare ,
Loper Bright Enterprises v Raimondo ,
SCOTUS ,
Statutory Interpretation
The U.S. Food and Drug Administration (FDA) published a final rule amending its regulations to include in vitro diagnostic products (IVDs) as devices, even those manufactured in a laboratory, and issuing policy to phase out...more
In March 2024, the Department of Health and Human Services—through the Office of the National Coordinator for Health IT (ONC)—released a draft 2024-2030 Federal Health IT Strategic Plan for public comment. A collaborative...more
On March 18, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services updated its bulletin on the Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates. The...more
For the past month or longer, many providers have reported a significant impact on their revenue cycle due to the cyberattack on Change Healthcare, LLC. In light of that impact, the Centers for Medicare & Medicaid Services...more
Nursing facilities should prepare to provide the Centers for Medicare & Medicaid Services (CMS) with additional information about their ownership, their managing employees and the parties providing certain financial and...more
12/5/2023
/ Business Ownership ,
Centers for Medicare & Medicaid Services (CMS) ,
Change of Ownership ,
Corporate Structures ,
Disclosure Requirements ,
Health Care Providers ,
Healthcare ,
Limited Liability Company (LLC) ,
Managers ,
Medicaid ,
Partnerships ,
Publicly-Traded Companies ,
REIT ,
Skilled Nursing Facility ,
Social Security Act ,
Trusts
In the CY 2024 Physician Fee Schedule Proposed Rule (the Proposed Rule), the Centers for Medicare & Medicaid Services (CMS) proposed a further delay in implementing its time-only definition for determining the “substantive...more