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Centers for Medicare & Medicaid Services (CMS) MDRP

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - May 9th - 10th, San Juan, Puerto Rico

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

ArentFox Schiff

Fast 5: Five Quick Regulatory Takeaways for Pharmaceutical Companies

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Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more

McDermott Will & Emery

HHS Takes Steps to Resolve 340B Medicaid MCO Duplicate Discount Confusion

On May 26, 2023, the Centers for Medicare and Medicaid Services (CMS) proposed an update to the Medicaid Drug Rebate Program (MDRP) rules, which includes provisions aimed at preventing 340B duplicate discounts on claims...more

King & Spalding

Major Shift in Best Price Proposed in Grab Bag of MDRP Reforms

King & Spalding on

The title of CMS’s May 26 proposed rule, “Misclassification of Drugs, Program Administration and Program Integrity Updates Under the MDRP,” buries the lede. Amid twenty Medicaid Drug Rebate Program-related proposals—some...more

Wiley Rein LLP

Initial Guidance Regarding the Inflation Reduction Act Medicare Prescription Drug Inflation Rebate Program

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The Inflation Reduction Act of 2022 (IRA) establishes the Medicare Prescription Drug Inflation Rebate Program, which requires drug companies to pay rebates, referred to as inflation rebates, to Medicare if they raise their...more

Blank Rome LLP

The Medicaid Drug Rebate Program and Value-Based Purchasing

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On March 23, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued long-awaited guidance regarding how drug manufacturers are to report multiple best prices (“BPs”) to the Medicaid Drug Rebate Program (“MDRP”)...more

Foley Hoag LLP - Medicaid and the Law

Oregon’s New Waiver Request to Exclude Accelerated Approval Drugs from Medicaid Coverage

Hello readers! Today’s post focuses on a topic we’ve touched on a few times in the past – Medicaid drug formularies. Back in December 2021, the state of Oregon released a draft Medicaid waiver proposal that caught the...more

Foley Hoag LLP - Medicaid and the Law

CMS Finalizes Changes to Medicaid Prescription Drug Rebate Program

Earlier this year, my colleague Ross Margulies and I told you about a new proposed rule issued by CMS that makes several changes to the Medicaid prescription drug rebate program, or the MDRP. Recently, CMS finalized the rule...more

Hogan Lovells

MDRP: CMS Final Rule on value-based purchasing, line extension definition, PBM accumulator programs

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On December 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule that materially modifies current Medicaid Drug Rebate Program (MDRP) regulations, largely finalizing the proposed rule dated June...more

Foley Hoag LLP - Medicaid and the Law

CMS Weighs in on FDA Importation Rule

On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from...more

Sheppard Mullin Richter & Hampton LLP

CMS’ Proposed Rule Promoting Value-Based Purchasing for Medicaid-Covered Drugs: The Comments are In!

On June 19, 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule, “Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based...more

Foley Hoag LLP - Medicaid and the Law

Paying for Value in Medicaid Prescription Drug Coverage

My colleague Ross Margulies has already told our readers about a provision of the new proposed Medicaid regulation governing how the program pays for outpatient prescription drugs under the Medicaid Drug Rebate Program, or...more

ArentFox Schiff

Proposed ‘Kitchen Sink’ Medicaid Rule Could Bring Changes for Pharmaceutical Manufacturers

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule on June 19, 2020 (the Proposed Rule) which, among other things, suggests updates to Medicaid policies and practices related to drug pricing and...more

King & Spalding

New Risks, New Rewards, New Exposure

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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

Hogan Lovells

Medicaid Drug Rebate Program proposed rule on value-based pricing, line extension, PBM accumulators

Hogan Lovells on

On June 17, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Proposed Rule (link) that would materially modify current Medicaid Drug Rebate Program (MDRP) regulations. Comments are due no later than 5:00 p.m....more

Cooley LLP

Blog: OIG Report on Reasonable Assumptions in Manufacturer Reporting

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Last week the Department of Health and Human Services Office of Inspector General (OIG) published a report titled “Reasonable Assumptions in Manufacturer Reporting of AMP and Best Prices” (Report) that reviewed the use of...more

King & Spalding

Congress Acts to Eliminate MDRP Misclassification

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President Trump on Thursday signed into law the most extensive set of amendments to the Medicaid Drug Rebate Program statute since the Affordable Care Act in 2010. The new law addresses the perception that drug manufacturers...more

Foley & Lardner LLP

Medicaid Drug Rebate Agreements: Changes Require Immediate Action By Pharmaceutical Manufacturers

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For the first time since the enactment of the Medicaid Drug Rebate Program (MDRP), the Centers for Medicare and Medicaid Services (CMS) revised the National Medicaid Drug Rebate Agreement (NDRA) entered into between drug...more

Hogan Lovells

MDRP: CMS issues new rebate agreement; all current agreements terminate October 1, 2018

Hogan Lovells on

On March 23, 2018, the Centers for Medicare and Medicaid Services (CMS) published Final Notice that implements a substantially revised Medicaid National Drug Rebate Agreement (NDRA). All agreements currently in place will...more

Hogan Lovells

2019 White House and HHS Budgets Released: Key Changes to Drug Pricing and Reimbursement Proposed

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On February 12, 2018, the White House Office of Management and Budget released an overview of the president's Fiscal Year (FY) 2019 Budget (the Budget), which makes, among many others, several proposals regarding drug pricing...more

Foley & Lardner LLP

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

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Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

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