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Final Rules Hospitals Prescription Drugs

American Conference Institute (ACI)

[Event] 15th Annual Advanced Forum on Managed Care Disputes and Litigation - May 2nd - 3rd, Chicago, IL

ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more

Holland & Knight LLP

CMS Releases CY 2024 OPPS and ASC Final Rule

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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 LLP

CMS Issues Final Rule Remedying Underpayments to 340B Covered Entities

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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

McDermott+

Policy Update - CMS Finalizes Remedy for 340B-Acquired Drugs Purchased in CYs 2018–2022

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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

Holland & Knight LLP

CMS Releases 2023 Hospital OPPS and ASC Payment System Final Rule

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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

Holland & Knight LLP

CMS Issues 2022 OPPS and ASC Payment System Final Rule

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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

Holland & Knight LLP

CMS Releases 2021 OPPS and ASC Payment System Final Rule

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The Centers for Medicare & Medicaid Services (CMS) has published the Calendar Year (CY) 2021 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule. Note that the...more

King & Spalding

FDA Finalizes Rule and Guidance to Implement Safe Importation Action Plan Aimed at Lowering Prescription Drug Prices

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On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more

Mintz - Health Care Viewpoints

340B Reimbursement Cut Update: 135 Hospitals File Suit to Block Rate Cuts Previously Ruled Unlawful

On December 16, 2019, a nationwide coalition of hospitals sued HHS to block implementation of the 340B rate cuts contained in the 2020 Hospital Outpatient Prospective Payment System (“OPPS”) Final Rule. As detailed in our...more

K&L Gates LLP

K&L Gates Triage: Looking Ahead to 2020: Developing Issues in Pharmacy Law and the 340B Drug Pricing Program

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In this episode, Ryan Severson and Victoria Hamscho discuss recent developments in pharmaceutical pricing and the 340B Drug Pricing Program heading into 2020, including reimbursement cuts for 340B drugs under the Outpatient...more

Sheppard Mullin Richter & Hampton LLP

340B Program-Participating Hospitals Object to CMS’s Proposed Cuts to 340B Program Reimbursement: CMS’s Recent Information...

Information Collection Request. On November 27, 2019, 340B Health, a nonprofit membership organization comprised of hospitals and health systems that participate in the federal 340B drug pricing program (“340B Program”),...more

Mintz - Health Care Viewpoints

CMS Ignores the Courts: 2020 Hospital Outpatient Prospective Payment System Final Rule Includes 340B Rate Cuts Already Ruled...

The Centers for Medicare and Medicaid Services (CMS) recently published the 2020 Hospital Outpatient Prospective Payment System (OPPS) rule, which finalizes a proposed reduction in Medicare Part B reimbursement for certain...more

King & Spalding

CMS Publishes Final Rule for CY 2020 Hospital Outpatient Prospective Payment System

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n November 1, 2019, CMS posted the final rule establishing the payment rates for the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgery Center (ASC) Payment System for calendar year (CY) 2020...more

Polsinelli

CMS Delays Price Transparency, Doubles Down on Site-Neutral and 340B Payment Policies in CY 2020 OPPS Final Rule

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Late last week, the Centers for Medicare & Medicaid Services (“CMS”) released the CY 2020 Hospital Outpatient Prospective Payment System (“OPPS”) final rule [CMS-1717-FC]. While many hospitals had hoped for relief from recent...more

K&L Gates LLP

K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 2

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In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...more

King & Spalding

District Court Order Paves Way for HHS to Appeal Decision Finding 340B Rate Cut Unlawful Without First Providing a Proposed Remedy...

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On July 10, 2019, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia granted HHS’ request for a final judgment, clearing the way for the government to immediately appeal his earlier decision that...more

Baker Donelson

EPA Issues New Hazardous Waste Pharmaceuticals Rule

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The United States Environmental Protection Agency (EPA) recently issued its Final Rule imposing new requirements for hazardous waste pharmaceuticals. The Hazardous Waste Pharmaceuticals Rule, issued February 22, 2019,...more

King & Spalding

Federal Court Declines to Vacate Secretary’s Ultra Vires 340B Rate Cut and Remands to CMS to Fashion Proper Remedy

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In a long-awaited ruling, on May 6, 2019, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia declined to vacate the Secretary’s CYs 2018 and 2019 Outpatient Prospective Payment System (OPPS)...more

Sheppard Mullin Richter & Hampton LLP

CMS Expands Telehealth Benefits under Medicare Advantage

On Friday, April 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) announced that it had finalized policies allowing Medicare Advantage plans (“MA Plans”) to include additional telehealth benefits in their basic...more

Sheppard Mullin Richter & Hampton LLP

340B Drug Pricing Program Litigation Update: Court Rejects CMS Drug Pricing Cuts

On December 27, 2018, the U.S. District Court for the District of Columbia issued an opinion that ruled against the Trump Administration in its plan to cut funding from the 340B Drug Pricing Program (“340B Program”). ...more

Verrill

No More Waiting: 340B Drug Pricing Program Pharma Oversight and Enforcement Rule To Be Effective January 1, 2019

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The U.S. Department of Health and Human Services (“HHS”) recently published a final rule on the 340B Drug Pricing Program (“340B Program”), moving the effective date for changes to the program up to January 1, 2019. Making...more

Holland & Knight LLP

CMS Releases the 2019 OPPS and ASC Payment System Final Rule

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• The Centers for Medicare & Medicaid Services (CMS) has issued the Calendar Year (CY) 2019 Final Rule that updates payment rates and policy changes in the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory...more

Holland & Knight LLP

CMS Releases the 2019 MPFS and QPP Final Rules

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• The Centers for Medicare & Medicaid Services (CMS) has published the Calendar Year (CY) 2019 Final Rule for the Medicare Physician Fee Schedule (PFS), which includes provisions related to Medicare physician payments as well...more

Holland & Knight LLP

340B Drug Pricing Program Final Rule Delayed … Again

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In a notice published on June 5, 2018, the Health Resources and Services Administration (HRSA) announced that the January 2017 340B Drug Pricing Program final rule (the “Final Rule”) will again be delayed. The Final Rule,...more

Sheppard Mullin Richter & Hampton LLP

340B Drug Pricing Program Litigation Update

In November of last year, we wrote about a preliminary injunction being sought by hospital advocacy groups attempting to stop implementation of the Trump administration’s cuts to the 340B Drug Pricing Program (“340B...more

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