U.S. Congress returns from a two-week recess this week and has lofty goals to draft, mark up and pass a reconciliation bill by Memorial Day 2025. The U.S. House of Representatives Committee on Energy and Commerce, which was...more
Looking Ahead: House to Vote on Compromise Budget Resolution On the heels of the U.S. Senate's passage of a compromise budget resolution, the U.S. House of Representatives is expected to consider the budget resolution on the...more
On March 12, 2025, in one of the Trump Administration’s first actions with respect to the Center for Medicare and Medicaid Innovation (CMMI), CMMI announced that it would prematurely terminate four alternative payment model...more
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more
The Trump Administration and 119th Congress will likely be targeting trillions of dollars in savings in the year ahead. Healthcare makes up a significant portion of mandatory spending and therefore likely will be a large part...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
Should Congress Stay or Should They Go Now? Congress has two more weeks to extend government funding past the September 30 deadline through a short-term continuing resolution (CR). So, the question isn’t really if they...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. This week's topics include...more
Although I previously declared January 2024 Medicare Advantage (MA) Month, this week has also been filled with news about the MA program. The Centers for Medicare & Medicaid Services (CMS) released the final rate announcement...more
Earlier this week, President Biden released his Fiscal Year (FY) 2025 President’s Budget. As a reminder, every year, the White House releases a budget that serves as its official funding request to Congress for the following...more
Site neutral payment proposals are currently a key topic among policymakers. This +Insight explores how Medicare fee-for-service (FFS) site-of-service patterns vary across states and metropolitan statistical areas (MSAs). Our...more
Introduction- Site neutral payment proposals may affect access differently across patient populations. In this +Insight, we focus on how site-of-service patterns for drug administration services, which both the Medicare...more
On January 25, 2024, CMS released a Request for Information (RFI) seeking public input on how it can enhance and increase transparency of Medicare Advantage (MA) data. CMS says that the RFI “builds on our existing MA data...more
The Centers for Medicare & Medicaid Services (CMS) released a final rule on Nov. 2, 2023, detailing how the agency will remedy underpayments from 2018 to 2022 for drugs acquired via the 340B Drug Pricing Program. The final...more
The Centers for Medicare & Medicaid Services (CMS) released the Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 Proposed Rule on July 7, 2023. CMS has published...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
On April 26, 2023, the House Energy and Commerce Committee Health Subcommittee held a legislative hearing on 17 healthcare bills, including one that would direct the Centers for Medicare & Medicaid Services (CMS) to implement...more
The Centers for Medicare & Medicaid Services (CMS or Agency) on April 10, 2023, published its annual proposed rule for the federal fiscal year (FY) 2024 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital...more