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
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
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
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
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
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 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
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
The U.S. Departments of Health and Human Services, Labor, and Treasury, and the Office of Personnel Management have issued "Requirements Related to Surprise Billing; Part I," an interim final rule to implement the No...more
The Big Picture - Until late December, few if any Medicare policy changes were anticipated as part of a year-end healthcare package, barring extensions of funding for programs that otherwise would have expired. But after...more
As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules expected to be effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law...more
On July 23, 2020, the Secretary of the Department of Health and Human Services ("HHS") issued another 90-day extension regarding free COVID-19 testing. The free COVID-19 testing requirement was set to expire on July 25, but...more
As the COVID-19 pandemic continues to spread across the United States, states, payors, and providers are looking for ways to expand access to telehealth services. Improving access to telehealth is an essential tool in...more
On March 17, 2020, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) issued a Policy Statement addressing the ability of physicians and other practitioners to reduce or waive patient...more
On March 17, 2020, the Department of Health and Human Service (“HHS”) Office of Inspector General (“OIG”) issued a policy statement recognizing the “regulatory flexibility necessary to adequately respond to COVID-19...more
While the COVID-19 emergency continues, Medicare will pay health care professionals to provide care by telehealth for Medicare beneficiaries in their homes, and HIPAA restrictions affecting the use of non-compliant video chat...more
Editor’s Note: In a new toolkit prepared for the Robert Wood Johnson Foundation, summarized below, Manatt Health helps insurance regulators understand the wide range of transparency and competition strategies available to...more
In November 2019, the U.S. Department of Health and Human Services, along with the U.S. Department of Treasury and the U.S. Department of Labor, (collectively, the Departments) released a proposed rule requiring group health...more
Federal executive agencies recently published two rules, one final and one proposed, aimed at publicizing the various costs associated with health care. A final rule, promulgated by the Department of Health and Human Services...more
Employer-sponsored health plans and health insurers may be required to post online - and to provide participants upon request - a range of pricing and cost-sharing information beginning in 2021. Proposed Affordable Care...more
On November 15, 2019, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury (collectively, the Departments), unveiled a proposed rule (scheduled to be published on November...more