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
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
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
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
The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule with comment...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
What are the cost drivers for different ambulatory services? How much does Medicare pay for outpatient knee replacements? How has Medicare volume changed over time for outpatient GI procedures? ...more
The Centers for Medicare and Medicaid Services (CMS) issued regulations applicable to Medicare Advantage (MA) plans—also commonly referred to as managed Medicare or Part C Medicare—in April 2023 (CMS 4201–F) that address,...more
On July 10, 2024, 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
The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1809-P),...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
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
CMS’s Hospital Price Transparency regulations require hospitals to make public the standard charges of the items and services that they provide. In the CY 2024 Hospital Outpatient Prospective Payment System Final Rule (CY...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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2023. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new General...more
In June of 2022, the Supreme Court of the United States unanimously held in American Hospital Association v. Becerra that the United States Department of Health and Human Services (“HHS”) and the Centers for Medicare and...more
Last week, CMS updated its technical implementation guide to the machine-readable file, a requirement of the Hospital Price Transparency Rule. The updated technical implementation guide—which contains data dictionaries, CSV...more
The Centers for Medicare & Medicaid Services (CMS) finalized its Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) payment rates on Nov. 2 for calendar year (CY) 2024. The Final Rule...more
In the buffet of regs (and eggs) released a couple of weeks ago, the fried egg served up by the Centers for Medicare & Medicaid Services (CMS) was the 340B Remedy Final Reg. Unlike the other final regs that will affect...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
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
CONGRESS - House Ways & Means Chair Smith, House Energy & Commerce Chair Rodgers and Senate Finance Ranking Member Crapo Call for Withdrawal of Nurse Staffing Mandate. Rep. Smith (R-MO), Rep. Rodgers (R-WA) and Sen. Crapo...more