Medical Device Legal News with Sam Bernstein: Episode 19
Midyear Premium Increases and Cafeteria Plan Rules
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
Collaborating Before The PTAB
On the afternoon of July 4, President Trump signed into law H.R. 1, the One Big Beautiful Bill Act – comprehensive budget reconciliation legislation that represents the core of President’s second-term domestic agenda and...more
On January 14, 2025, the US Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), jointly issued Part 69 of a series of...more
Employer-sponsored health plans would be required to cover over-the-counter contraception, including condoms and emergency contraception, without a prescription and without cost sharing under newly proposed Affordable Care...more
Most healthcare providers understand that routinely waiving patient cost-sharing obligations creates compliance issues under the Anti-Kickback Statute, the Civil Monetary Penalties Law, and third-party payor agreements which...more
On July 8, 2024, the Office of Inspector General (OIG) updated its General Questions on Fraud and Abuse Authorities (FAQs) related to the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Prohibition of Civil...more
The U.S. Departments of Labor (DOL), Health and Human Services (HHS), and Treasury, along with the Office of Personnel Management (OPM), released FAQs about the implementation of Title I of Division BB of the Consolidated...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
The HHS Office of Inspector General issues a favorable advisory opinion regarding a sponsor’s payment of cost-sharing amounts in a Medicare Category B IDE Clinical Study; the FDA issues guidance regarding the use of Digital...more
The Centers for Medicare & Medicaid Services (CMS) has announced new measures to enhance access to behavioral health services for Medicare beneficiaries and improve hospital price transparency as part of the final rule for...more
On September 29, the Centers for Medicare & Medicaid Services (CMS) reported that the federal Departments of Health and Human Services, Labor, and the Treasury departments are seeking public input on the possibility of...more
5 Questions is a periodic feature produced by Cornerstone Research, which asks our professionals, senior advisors, or affiliated experts to answer five questions. We interview Professor Erin Trish, of the Schaeffer Center...more
On August 24, 2023, health care providers in Texas scored yet another victory when a federal court vacated additional portions of the Biden Administration’s rulemaking under the federal No Surprises Act (the Act). This marked...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more
Group health plans must comply with several new requirements set forth by the Consolidated Appropriations Act of 2021 (CAA) and the Transparency in Coverage regulations (TiC Regulations) under the Affordable Care Act (ACA). ...more
On August 19, 2022, the US Departments of Health and Human Services (HHS), Labor and Treasury posted a final rule revising portions of the federal No Surprises Act (NSA). Generally, the rule finalizes three aspects of the...more
On Feb. 23, 2022, the U.S. District Court for the Eastern District of Texas granted a motion for summary judgment in favor of the Texas Medical Association and Dr. Adam Corley, striking down a portion of an interim final rule...more
On January 1, 2022, the Biden Administration’s Federal No Surprises Act (NSA) took effect. The NSA provides new protections against unsuspected medical bills. It is intended to combat the negative impact of the rising cost of...more
The Families First Coronavirus Response Act (FFCRA) was enacted on March 18, 2020, and generally requires group health plans to provide benefits for certain items and services related to COVID-19 testing when those items or...more
Back in June of 2019, the United States Preventive Services Task Force (“USPSTF”) released an A-rated recommendation for HIV Preexposure Prophylaxis (“PrEP”). As a result, the Affordable Care Act’s preventive care rules...more
On July 1, 2021, the Biden-Harris Administration issued “Requirements Related to Surprise Billing; Part 1,” an interim final rule (IRM) that will restrict health care providers and facilities from sticking patients with...more
On 1 July 2021, the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (the Departments) issued an interim final rule (IFR) implementing certain provisions of the No Surprises...more
On July 1, the Department of Health and Human Services (HHS), Department of Labor, and Department of the Treasury (Departments) jointly issued interim final rules (IFR) implementing certain aspects of the No Surprises Act...more
On July 1, 2021, the Office of Personnel Management, Department of the Treasury, Department of Health and Human Services (“HHS”), and Department of Labor (“DOL”) (collectively, the “Departments”), released the interim final...more
Today, the Departments of Health and Human Services (HHS), Labor, and Treasury (the Departments) published an interim final rule (the Interim Final Rule) implementing certain provisions of the No Surprises Act,[1] which aims...more