K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more
With the One Big Beautiful Bill Act (OBBB) passed by U.S. Congress and signed into law, Congress now has less than three weeks that it will be in session before government funding expires on Sept. 30, 2025. Appropriators will...more
On November 1, the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to extend virtual direct supervision—i.e., the ability to provide direct supervision through real-time, audio-visual technology (rather...more
This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now...more
As mentioned last week, the Centers for Medicare & Medicaid Services (CMS) recently put out a large buffet of regs – too many to digest in one blog post. While we focused on the Calendar Year (CY) 2025 Physician Fee Schedule...more
Republicans Win Control of White House and Senate, Seem Poised to Maintain Control of House. Former President Donald Trump will return to the White House, and Republicans also gained control of the Senate. Some toss-up House...more
While we all are focused on the election results, let’s take a quick break to digest some regs and eggs. The Centers for Medicare & Medicaid Services (CMS) “spoiled” all of us in the health policy world with a huge buffet of...more
On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2025 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B...more
In case you need a reminder given everything going on in Washington, DC, the Calendar Year (CY) 2025 Physician Fee Schedule (PFS) and CY 2025 Outpatient Prospective Payment System (OPPS) proposed regs were released a couple...more
Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more
The major calendar year proposed regs are now out, with thousands of pages of text to digest. Since a plethora of issues are embedded in these regs, including the Calendar Year (CY) 2025 Physician Fee Schedule (PFS) and the...more
On July 10, the Centers for Medicare and Medicaid Services (CMS) released its annual Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule, which provides...more
Senate HELP Committee Holds Hearing on Medical Debt. The hearing examined the negative impacts of medical debt and explored potential solutions to address the growing issue. Senators and witnesses highlighted the disparity...more
It’s Thanksgiving week, so instead of eating eggs with your regs, you should sit back, relax and reflect on the regs you are thankful for as you eat your turkey legs (or whatever you enjoy on Thanksgiving). Many of the...more
On November 16, the Centers for Medicare & Medicaid Services (CMS) published its Medicare Physician Fee Schedule (PFS) final rule for calendar year 2024 (PFS Final Rule). According to the CMS press release, the PFS Final Rule...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
CONGRESS - Senate Finance Committee Holds Markup on Better Mental Health Care, Lower-Cost Drugs, and Extenders Act. The bipartisan package includes Medicare and Medicaid extenders, provisions to expand the mental health...more
A few weeks ago, Regs & Eggs discussed the constant give and take between federal agencies and Congress as they both work on overlapping policies and objectives. The major regs released last week provide an excellent example...more
GOVERNMENT FUNDING EXPIRES SOON - The government will run out of funding in 11 days, on November 17. The House will continue to work to advance annual appropriations bills this week. However, a continuing resolution (CR)...more
Hungry for some Regs & Eggs? Well, you are in luck, because this week, the Regs & Eggs buffet is open, with your choice of eggs made any style. Enough regs were released this week to feed an entire family—and the...more
Sharpen your pencils and locate your reading glasses: the final Medicare payment regulations for calendar year (CY) 2024 will be released within the next week. In the last Regs & Eggs blog post, I discussed a major issue...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 Centers for Medicare & Medicaid Services (“CMS”) has announced its proposed rules for the Hospital Outpatient Prospective Payment (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment Systems, as well as its calendar...more
As most of you already know, the Centers for Medicare & Medicaid Services (CMS) recently released two Medicare payment regulations: the Calendar Year (CY) 2024 Physician Fee Schedule (PFS) proposed reg and the CY 2024...more