News & Analysis as of

Reimbursements Centers for Medicare & Medicaid Services (CMS) Medicare Part B

ArentFox Schiff

Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know

ArentFox Schiff on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more

ArentFox Schiff

The 2025 Proposed Hospital Outpatient Prospective Payment System and Physician Fee Schedule Rules: What Pharma Stakeholders Need...

ArentFox Schiff on

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

McDermott+

Policy Update - CMS Releases CY 2024 Physician Fee Schedule Final Rule

McDermott+ on

On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2024 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The First Anniversary of the Inflation Reduction Act: A Year in Review

August 16, 2023 marked the one-year anniversary of the enactment of the Inflation Reduction Act (“IRA”). The first 365 days since the IRA’s passage brought the implementation of a number of significant changes to the Medicare...more

McDermott+

CMS Releases Proposed Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018–2022

McDermott+ on

On July 7, 2023, the Centers for Medicare and Medicaid Services (CMS) released the proposed rule Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 to address how...more

Verrill

CMS Proposes to Make Lump-Sum Payments to Hospitals for Underpayments for Drugs Purchased Through the 340B Program During...

Verrill on

Last week CMS issued its anticipated proposed rule to implement the Supreme Court’s decision last year which ruled that CMS’ reduction in Medicare payments for Part B outpatient drugs purchased through the 340B program...more

Mintz - Health Care Viewpoints

CMS Proposed Rule for Refunding Overpayments Would Align With False Claims Act “Knowledge” Standard

The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more

Foley & Lardner LLP

CMS Finalizes Changes for Telehealth Services for 2023

Foley & Lardner LLP on

On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) released its final 2023 Medicare Physician Fee Schedule (PFS) rule. As finalized, some of the most significant telehealth policy changes include: ...more

Bass, Berry & Sims PLC

CMS Reverses 340B Payment Cuts for 2023 but Does Not Address Remedy for Prior Years

Bass, Berry & Sims PLC on

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

Mintz - Health Care Viewpoints

PAMA Laboratory Reporting In Flux: ACLA Wins HHS Lawsuit and Congress Introduces PAMA Amendment Legislation

Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory...more

Foley & Lardner LLP

340B Rate Cuts Reversed by CMS for 2023

Foley & Lardner LLP on

The Centers for Medicare and Medicaid Services (CMS) has announced that it “fully expects” to reverse Medicare Part B rate cuts for separately payable drugs acquired through the 340B Drug Pricing Program, resulting in an...more

Quarles & Brady LLP

U.S. Supreme Court Sides with 340B Hospitals in Significant $1.6 Billion Part B Drug Payment Ruling

Quarles & Brady LLP on

On June 15, 2022, after many years of ongoing litigation, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain...more

Sheppard Mullin Richter & Hampton LLP

Executive Order on Promoting Competition in the American Economy: The Biden Administration Considers Drug Pricing Strategies While...

On August 10, 2021, the Centers for Medicare and Medicaid (“CMS”) published a proposed rule (“Proposed Rule”) to rescind the Most Favored Nation Model (“MFN Model”) interim final rule that was published on November 26, 2020...more

K&L Gates LLP

CMS Proposes to Rescind Most Favored Nation Drug Pricing Rule

K&L Gates LLP on

The Centers for Medicare & Medicaid Services (CMS) published a proposed rule (Proposed Rule) on 10 August 2021 that rescinds the Most Favored Nation (MFN) Model interim final rule, which was issued on 27 November 2020 (the...more

Polsinelli

Medicare 340B Payment Cut Déjà vu – Biden Administration Continues Trump Administration Part B Payment Reductions

Polsinelli on

On Monday, July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the CY 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule). While the Proposed Rule...more

Sheppard Mullin Richter & Hampton LLP

Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets

On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment...more

Hogan Lovells

Medicare links Part B payment rates to international prices: Most Favored Nation Model

Hogan Lovells on

On November 20, 2020, the U.S. Centers for Medicare & Medicaid Services (CMS) issued an interim final rule (IFR) with comment period implementing a mandatory “Most Favored Nation” demonstration model (MFN Model) to test...more

King & Spalding

New Risks, New Rewards, New Exposure

King & Spalding on

Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

Polsinelli

340B Covered Entities Beware: CMS Proposes Drastic Drug Reimbursement Rate Cuts

Polsinelli on

In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more

Mintz - Health Care Viewpoints

CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more

Alston & Bird

New Initiatives for the New Year: Highlights of the OIG’s 2017 Work Plan

Alston & Bird on

On November 10, 2016, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued its 2017 Work Plan. The 2017 Work Plan outlines the areas of special concern to the OIG and...more

King & Spalding

CMS Proposes Sweeping Changes to Medicare Reimbursement for Clinical Diagnostic Laboratory Tests

King & Spalding on

First Data Collection Period for Clinical Laboratories Is July 1, 2015 to December 31, 2015 - In the October 1, 2015 Federal Register, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule...more

Mintz - Health Care Viewpoints

CMS Publishes Long-Awaited PAMA Proposed Rule

On September 25, 2015, the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule...more

King & Spalding

CMS to Congress: Sequestration of Cancer Drug Reimbursement to Continue

King & Spalding on

A June 3, 2013 letter from CMS Administrator Marilyn Tavenner to Rep. Pete Sessions (R-Tex.) states that the agency does not believe it has any discretion under the Budget Control Act of 2011 to exempt Part B cancer drug...more

Womble Bond Dickinson

Recent Changes Impact Appeal of Medicare Denials and Reimbursement Strategies

Womble Bond Dickinson on

Recovery Audit Contractors (“RACs”) and other Centers for Medicare and Medicaid Services (CMS) contractors are charged with identifying overpayments made by Medicare to healthcare providers. However, with the increase in RAC...more

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