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
As law firm clients demand greater speed, cost-efficiency, and transparency, legal teams are under pressure to deliver more — without overextending internal resources or compromising quality. In this fireside chat, we’ll...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
On January 8, Massachusetts Governor Maura Healy signed into law “An Act Relative To Pharmaceutical Access, Costs And Transparency.” The Act will have a profound impact on all parties involved in setting and applying drug...more
On January 14, 2025, the Federal Trade Commission (FTC) Office of Policy Planning released a second Interim Staff Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit...more
On November 26, 2024, Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule revising the Medicare Advantage (“MA”) Program (Part C), Medicare Prescription Drug Benefit Program (Part D), Medicare Cost Plan...more
Employers providing health plan coverage through a high-deductible health plan (HDHP) may need to amend their HDHP before year-end to remove first-dollar telehealth coverage. Although prior regulatory relief permitted...more
Recently HHS issued a memorandum announcing the maximum annual limitation on cost sharing (a/k/a out-of-pocket maximum) for 2026 and the IRS issued Rev. Proc. 2024-40 announcing the cost-of-living adjustments to certain...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
Recent scrutiny of pharmacy benefit managers, also known as “PBMs,” has resulted in various lawsuits alleging that the high drug costs they charge violate ERISA. Among the first lawsuits in what appears to be a wave of new...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
On June 21, 2024, the United States Court of Appeals for the Fifth Circuit (“Fifth Circuit”) issued its ruling in Braidwood v. Becerra. The court determined that the Affordable Care Act’s (“ACA”) requirement that group...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
In a recent ruling, a California appeals court found an arbitration agreement with an eyewear store employee that was presented on a take-it-or-leave-it basis required an arbitrator to apply the laws of another state,...more
Every year, the New Jersey legislature passes statutes that impact healthcare beyond rate increases under the Medicaid program. Last year was no different, and the discussion below highlights some of those statutes, such as...more
The U.S. Department of Energy, Office of the Under Secretary for Infrastructure (S3) (DOE) held a webinar and released a memorandum on May 24, 2024, that provided key updates and guidance regarding award negotiations for...more
On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...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 Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...more
Note: This is the second article in our series on capturing industrial base funding from the U.S. Department of Defense In our last post, we discussed the Defense Production Act (DPA) and Technology Investment Agreement...more
Once again, the U.S. Departments of Labor, Health and Human Services, and the Treasury have issued guidance on the Affordable Care Act’s (ACA) required coverage of contraception without cost sharing, clarifying the permitted...more
Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more
In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more
Last week, the Departments of Labor, Treasury and Health and Human Services (“the Departments”) issued an FAQ about the final Transparency in Coverage rules (“TiC Rules”). This FAQ addresses compliance with cost‑sharing...more
Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more