On December 3, 2025, the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) published an interim final rule (the 2025 Interim Rule) that repeals certain provisions of the...more
12/4/2025
/ Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Healthcare ,
Interim Final Rules (IFR) ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
One Big Beautiful Bill Act ,
Regulatory Oversight ,
Regulatory Reform ,
Vacated
As a follow-up to our October 3, 2025 alert, another court, this time the US Court of Appeals for the Seventh Circuit, held that percent-based compensation is not per se a kickback. In the matter of United States of America...more
10/31/2025
/ Anti-Kickback Statute ,
Appeals ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Durable Medical Equipment ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicare ,
Medicare Fraud ,
Popular ,
Trump Administration ,
White Collar Crimes
In 2018, the Eliminating Kickbacks in Recovery Act (EKRA) made it an offense for someone to knowingly and willfully pay or offer any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or...more
10/6/2025
/ Appeals ,
Appellate Courts ,
Breach of Contract ,
Clinical Laboratory Testing ,
Contract Disputes ,
Criminal Prosecution ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Enforcement Actions ,
Fraud ,
Healthcare Fraud ,
Kickbacks ,
Marketing ,
Statutory Interpretation
Providers continue to question how to handle collection of dispute resolution awards under the federal No Surprises Act (NSA) as the federal courts remain split on their interpretation of the NSA. Most recently, in June 2025,...more
9/25/2025
/ Appeals ,
Appellate Courts ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Federal Court Litigation ,
Health Care Providers ,
Health Insurance ,
Insurance Industry ,
Insurance Litigation ,
No Surprises Act (NSA) ,
Private Right of Action ,
Statutory Interpretation
The contentious Nursing Home Minimum Staffing Rule (Rule), which established minimum staffing requirements for federally funded long-term care facilities (LTC) such as skilled nursing facilities (SNFs) for Medicare and...more
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
Congress has extended telehealth flexibilities through its recent federal spending bill, H.R. 1968, titled “Full-Year Continuing Appropriations and Extensions Act, 2025” (the Act). Notably for health care providers, among...more
There are still several unsettled legal issues regarding the standards applicable to a False Claims Act (FCA) claim, such as the standard to prove causation when an FCA claim is based on a violation of the Anti-Kickback...more
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
The Drug Enforcement Administration (DEA), in concert with other federal agencies, has taken various steps in the past few months to strengthen a practitioner’s ability to prescribe controlled substances via telemedicine, a...more
2/25/2025
/ Controlled Substances ,
DEA ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Care Providers ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Rulemaking Process ,
Ryan Haight Act ,
Telehealth ,
Telemedicine
The Department of Justice Antitrust Division (DOJ), the Federal Trade Commission (FTC), and the Department of Health and Human Services (HHS) (together the Agencies) launched a cross-government agency request for information...more
2/13/2025
/ Acquisitions ,
Antitrust Division ,
Competition ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Health Insurance ,
Healthcare ,
Hospitals ,
Mergers ,
Private Equity
We continue our New Jersey Regulatory Update with this Part II, which focuses on regulations that were finalized in the second half of 2024 and impact healthcare. For example, as a continuation of price transparency efforts,...more
Below is Part I of our New Jersey Regulatory Update focusing on regulations that were finalized in 2024 by various New Jersey agencies that impact healthcare. The final regulations range from additional transparency...more
1/30/2025
/ Continuing Education ,
Criminal Background Checks ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Licensing Rules ,
Medicaid ,
Mental Health ,
New Jersey ,
Nursing Homes ,
Regulatory Requirements ,
Reporting Requirements ,
Social Welfare Organizations
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
The federal government has made a variety of changes to federal requirements aimed at improving the quality of care at long-term care facilities across the country. In May 2024, the United States Department of Health and...more
1/9/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Final Rules ,
Health Care Providers ,
Healthcare Facilities ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
Nursing Homes ,
Quality of Care Standards ,
Regulatory Requirements
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
A recent federal court decision has the potential to significantly impact the future of False Claims Act (FCA) lawsuits initiated by whistleblowers and to upend the FCA. In United States of America ex rel. Clarissa Zafirov v....more
The Centers for Medicare & Medicaid Services (CMS) recently published a proposed rule, 89 FR 61596, that revives portions of a 2022 proposal to amend the Medicare Overpayment Rule. The 2024 proposed rule comes after...more
Certified registered nurse anesthetists (CRNAs) in Washington, DC can now practice without a collaborating physician following the DC legislature’s recent passing of Bill B25-0545, also known as the Health Occupations...more
The Centers for Medicare & Medicaid Services (CMS), the Office of the National Coordinator for Health Information Technology (ONC), and thr Department of Health and Human Services (HHS) published 89 FR 51238 (the Final Rule),...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
Two New Jersey healthcare facilities that violated the New Jersey Patient Safety Act, N.J.S.A. §§ 26:2H-12.23 to -12.25, (PSA), must provide plaintiff patients with internal reports and documents relating to adverse events,...more
The Master List for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) comes from a November 2019 final rule that created the list to serve as a library of items that have been identified as potential...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