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
In last week’s Preview, we said this week would be one to watch for movement on the shutdown because of a few important dates. On November 1, 2025, the Affordable Care Act (ACA) Marketplace open enrollment began, where...more
On October 31, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Medicare Physician Fee Schedule (PFS) final rule, which includes policies related to Medicare physician payment and...more
McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. October 9, 2025 – Several recent Regs & Eggs blog posts have focused on comments that stakeholders submitted on two major...more
McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. September 25, 2025 – We’ve enjoyed a buffet of comments on regs (and eggs) recently. In our last post, we discussed comments...more
In the latest episode of Health Law Diagnosed, Of Counsel Bridgette Keller is joined by Associate Hassan Shaikh for a discussion on noteworthy developments relating to the IRA and drug pricing. Together, Bridgette and Hassan...more
On September 5, 2025, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) Office of Evaluation and Inspections (OEI) released a Data Snapshot (OEI-BL-24-00420) finding that Medicare Part B...more
In July 2025, CMS issued its 2026 Hospital Outpatient Prospective Payment System (OPPS) proposed rule, which includes two significant 340B policies. First, it includes cuts in the OPPS rates paid to hospitals to accelerate...more
ACI's virtual 6th Annual Passport to Proficiency on Rx Drug Pricing & Rebate Fundamentals will help you master the fundamentals, comprehend the consequences of new developments, and prepare for the complexities and nuances of...more
This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2025, including the results of the US Department of Justice’s (DOJ) 2025 National Health Care Fraud Takedown, DOJ...more
The Centers for Medicare & Medicaid Services recently published the calendar year (“CY”) 2026 proposed rule for Medicare payment for services provided in hospital outpatient departments under the Outpatient Prospective...more
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
Consistent with recent attention from Congress and rhetoric from the Trump administration, the Calendar Year 2026 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule (the Proposed Rule) includes...more
On July 15, 2025, CMS issued a proposed rule with updates to the Medicare payment rates for the Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for...more
Last week, the Centers for Medicare & Medicaid Services (CMS) issued two major regs: the calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS) proposed rule and the CY 2026 Outpatient Prospective Payment System (OPPS)...more
On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released the CY 2026 Outpatient Prospective Payment System (OPPS) proposed rule. The proposed rule includes a provision that would increase the reduction in...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
The Centers for Medicare & Medicaid Services (CMS) on July 15, 2025, issued the Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems proposed rule, which proposes updates to the...more
Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules relating to how it plans to administer the Medicare Part B program for the next calendar year: the physician fee schedule (PFS)...more
THIS WEEK’S DOSE - - OBBBA implementation begins. While the administration focuses on implementing the new law, some lawmakers are already discussing adjustments to health provisions in the One Big Beautiful Bill Act...more
On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Proposed Rule [CMS-1834-P],...more
On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the 2025 hospital outpatient prospective payment system and ambulatory surgical centers (ASC) rule. The rule updates Medicare payment rates for...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
On November 1, 2024, CMS issued a final rule with updates to the Medicare payment rates for the Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) Payment System for...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