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 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
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
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
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
Summary - The Departments of Labor, Health and Human Services, and the Treasury have issued guidance that coordinates application of the No Surprise Billing rules under the Consolidated Appropriations Act, 2021, with the...more
On March 30, Judge Reed O’Connor of the U.S. District Court for the Northern District of Texas issued a decision in Braidwood Management Inc. v. Becerra (“Braidwood”), invalidating the Affordable Care Act’s (“ACA’s”) mandate...more
Where did the time go? Just a brief 1,199 days after it began, the COVID-19 Public Health Emergency (PHE) is coming to an end. The PHE formally ends on May 11, 2023, short of any unexpected developments. And that means the...more
On March 30, 2023, the District Court for the Northern District of Texas issued an opinion and order in Braidwood Mgmt. Inc. v. Becerra that vacates the implementation and enforcement of certain preventive service provisions...more
A few short weeks ago we told you in a blog post that, with only four days’ notice, the Departments of Labor, Treasury, and HHS (the Departments) required that, starting January 15, 2022, group health plans cover FDA-approved...more
On Monday, the government issued frequently asked questions (FAQs) requiring employer group health plans (Plans) and health insurance issuers to cover certain over-the-counter (OTC) COVID-19 tests at no cost to the...more
Effective January 15, 2022, health plans are required to cover the cost of over-the-counter (“OTC”) COVID-19 test kits obtained without a health care provider’s prescription or clinical assessment. This new requirement was...more
Congress kicks off this week with three weeks to go before the March 23 omnibus spending deadline. At this point it’s still not entirely clear what will be tacked on to this spending package, but immigration, market...more
Massachusetts employers with 6 or more employees will soon be required to prepare and file a new health care reporting form referred to as the “healthcare coverage form.” While reminiscent of the now repealed “Health...more
In this episode of Triage, Amanda Makki and Corbin Santo of the K&L Gates Public Policy and Law practice group discuss several fundamental issues that are currently at the center of the health care debate in Washington, DC....more
Holland & Knight issued an alert in May 2016 regarding litigation by the U.S. House of Representatives against the Obama Administration and the decision of the U.S. District Court for the District of Columbia enjoining any...more
On October 23, the U.S. Department of Labor, the Department of Health and Human Services, and the Department of the Treasury (collectively, the “Departments”) jointly issued answers to frequently asked questions regarding the...more
This past June, leaders from health systems, outpatient services companies, health insurers, IT and equipment suppliers, health retailers, home care providers, pharmaceutical companies, and investors gathered in Chicago for...more
Illinois joins a growing number of states to pass laws requiring that hospitals provide notice to patients who are placed under observation status. 210 ILCS 86/6.09b As with the recent federal NOTICE Act, the laws respond to...more
The Centers for Medicare & Medicaid Services (“CMS”) recently announced that, beginning January 1, 2017, Medicare Advantage plans in Arizona, Indiana, Iowa, Massachusetts, Oregon, Pennsylvania and Tennessee will be permitted...more
The Department of the Treasury, DOL, and Department of Health and Human Services (HHS) issued final rules regarding coverage of certain preventive services required to be provided under ACA without cost sharing by...more
This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more
On September 1, 2015, the Centers for Medicare & Medicaid Services (“CMS”) announced[1] the opportunity for plan sponsors to test value-based insurance design (“VBID”) in the Medicare Advantage (“MA”) market. VBID refers to...more
On September 1, 2015, CMS unveiled a new Medicare Advantage Value-Based Insurance Design (MA-VBID) model, which will allow Medicare Advantage plans to offer clinically-nuanced benefit packages aimed at improving quality of...more
On August 12, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 15-11, finding that a program to supply a limited amount of free cancer drugs to federal health...more