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
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
On January 16, 2023, the Department of Health and Human Services (“HHS”) dropped its appeal of the U.S. District Court for the District of Columbia’s September 29, 2023 decision that vacated a portion of the 2021 Notice of...more
On December 21, 2023, the OIG issued a favorable advisory opinion (Advisory Opinion 23-11) regarding the proposed subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial. The...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
The U.S. Environmental Protection Agency's (EPA) Clean Ports Program is a $3 billion program established by the Inflation Reduction Act (IRA) to fund zero-emission (ZE) port equipment and technology, as well as assist U.S....more
Summary - Employers taking advantage of copay accumulator programs now face unexpected administrative complications following a recent federal court decision....more
On September 29, 2023, the U.S. District Court for the District of Columbia vacated a Trump-era rule from 2021 that allowed insurers to exclude drug manufacturer co-pay support coupons and assistance from a patient’s annual...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
California Attorney General Rob Bonta submitted a letter to federal agencies urging the federal government to adopt regulations and statutory protections to help protect patients who may need to use medical credit cards and...more