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
Happy Halloween! In the health policy world, there are two things on everyone’s mind this spooky season: the upcoming election and the major calendar year (CY) 2025 Medicare fee-for-service (FFS) final regs that should be...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
As I mentioned last week, comments are in on major calendar year (CY) Medicare payment regulations. Besides the CY 2025 physician fee schedule, another big reg is the CY 2025 Outpatient Prospective Payment System (OPPS)...more
On September 6, 2024, CMS released revised guidance regarding the process by which rural hospitals and outpatient facilities can participate in Medicare as a Rural Emergency Hospital (REH) rather than a Critical Access...more
The Centers for Medicare & Medicaid Services (CMS) recently published two proposed rules that could affect Medicare reimbursement for cardiology services. On July 22, 2024, CMS published the Calendar Year (CY) 2025 Hospital...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
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
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, 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
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
On July 10, the Centers for Medicare & Medicaid Services (CMS) proposed to extend virtual direct supervision—i.e., the ability to provide direct supervision through real-time, audio-visual technology (rather than in-person...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
On June 27, 2024, CMS issued a proposed rule updating payment rates and policies under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services provided to Medicare beneficiaries on or...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
In the wake of persistent drug shortages that compromise patient care and safety, the Biden administration and Congress have proposed policies to strengthen the pharmaceutical supply chain. Using authorities under both...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
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
House Energy and Commerce Health Subcommittee Holds Legislative Hearing on 19 Bills. Lawmakers discussed 19 pieces of legislation designed to support patients and caregivers in the key areas of autism, heart defects,...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
Recent federally qualified health center (FQHC) litigation highlights the impact state Medicaid agencies have on FQHC reimbursement. The important decisions summarized below all involve FQHC disputes over state Medicaid...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
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
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