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
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
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
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
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
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
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
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) 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 - 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
On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2024 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Final Rule [CMS-1786-FC]. The...more
On November 2, 2023, the Centers for Medicare and Medicaid Services (CMS) finalized the rule Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the Calendar Years 2018–2022 to addresses how the...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
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 November 1, 2022, CMS published a final rule to update the payment policies, payment rates, and other provisions for services furnished under the Medicare Outpatient Prospective Payment System (OPPS) and the Ambulatory...more
The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2022, released the calendar year (CY) 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule...more
On November 3, the Centers for Medicare & Medicaid Services (CMS) issued an update to its Medicare Part B drug payment policy for hospitals participating in the 340B drug pricing program and reversed payment cuts in place...more
Consistent with the US Supreme Court’s ruling in AHA v. Becerra and its statements in the 2023 Outpatient Prospective Payment System (OPPS) Proposed Rule, the Centers for Medicare & Medicaid Services (CMS) has finalized its...more
On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued final rules concerning the 2023 Hospital Outpatient Prospective Payment System (OPPS) payment rates and 2023 Medicare Physician Fee Schedule...more
On October 13, 2022, CMS announced that it will revert to paying the statutory rate of average sales price (ASP) plus 6% for 340B-acquired drugs on a prospective basis. This announcement comes on the heels of a September 28,...more
On July 15, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule to update the payment policies, payment rates, and other provisions for services furnished under the Medicare Outpatient...more
Earlier this month, the Centers for Medicare and Medicaid Services (CMS) released its final rules for the 2022 Medicare Physician Fee Schedule (PFS Final Rule) and 2022 Medicare Hospital Outpatient Prospective Payment System...more
The Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule on Nov. 2, 2021,...more
New Rule Finalizes Penalties for Violating the 2021 Price Transparency Rule - On November 2, 2021, CMS published the 2022 Hospital Outpatient Prospective Payment System Final Rule that addressed its previously-proposed...more
There were no major surprises when the Medicare hospital outpatient prospective payment system (OPPS) and physician fee schedule (PFS) Final Rules were released on November 2, 2021, but there are still several financial and...more