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Medicaid Drug Rebate Program Medicare Part D

McDermott Will & Emery

CMS Sneaks 340B Billing Proposals into Medicare Physician Fee Schedule: What 340B Stakeholders Need to Know

McDermott Will & Emery on

On July 10, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Medicare Physician Fee Schedule (MPFS) proposed rule, which includes proposals related to identification of Medicare Part B and Part D claims...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

Hogan Lovells

CMS Issues Revised Medicare Part B and Part D Inflation Rebate Guidance

Hogan Lovells on

On December 14, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “revised” guidance documents implementing the Medicare Part B and Part D inflation rebate provisions of the Inflation Reduction Act of...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

Mintz - Health Care Viewpoints

Mintz IRA Update — Other Key IRA Programs and Developments: The Medicare Prescription Drug Inflation Rebate Program and Maximum...

Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...more

McDermott Will & Emery

CMS Issues Guidance on Medicare Prescription Drug Inflation Rebate Program

On February 9, 2023, the Centers for Medicare and Medicaid Services (CMS) issued initial program guidance related to the implementation of the Prescription Drug Inflation Rebate Program. The rebate program was authorized...more

Sheppard Mullin Richter & Hampton LLP

CMS Releases Guidance on Implementation of Rebate Programs for Certain Medicare Part B and Part D Drugs

On February 9, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released two highly-anticipated guidance documents (the “Guidance”) detailing the agency’s proposed implementation of the Medicare Part B (“Part B”)...more

McDermott Will & Emery

The Inflation Reduction Act of 2022: Healthcare Provisions

After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote...more

ArentFox Schiff

Drug Pricing Reform Finally Becomes Law: What the Inflation Reduction Act Means for Pharma

ArentFox Schiff on

After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more

Goodwin

U.S. Senate Passes Significant Drug Pricing Reform in the Inflation Reduction Act of 2022

Goodwin on

​​​​​​​On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more

Mintz - Health Care Viewpoints

Medicaid Best Price 101: A Review of Medicaid Best Price Policy and New CMS Guidance on Medicaid Best Price Reporting for Value...

At the end of March 2022, the Centers for Medicare & Medicaid Services (CMS) released guidance to drug manufacturers and states on reporting Medicaid Best Price under value based purchasing (VBP) arrangements (Medicaid Best...more

Hogan Lovells

MDRP and 340B: Updates from last week

Hogan Lovells on

On October 13, 2021, the in-person portion of the annual informaconnect Medicaid Drug Rebate Program (MDRP) Conference concluded in New Brunswick, New Jersey. A day earlier, on October 12, 2021, a joint hearing was held in...more

Mintz - Health Care Viewpoints

Biden Administration’s Drug Pricing Plan Calls for Bold Action by Congress

It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9,...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - August 2021

Latham & Watkins LLP on

Drug Pricing Initiatives: US lawmakers continue to debate the drug pricing measure introduced by House Democrats, H.R. 3 (the Elijah E. Cummings Lower Drug Costs Now Act). Among other things, H.R. 3 would empower the...more

Hogan Lovells

Ramping up the drug pricing debate: Dueling bills and paying for health care infrastructure

Hogan Lovells on

The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more

King & Spalding

Implementation of Final Rule Excluding PBM Rebates from Discount Safe Harbor Delayed Until 2023

King & Spalding on

Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more

Mintz - Health Care Viewpoints

HHS Issues Controversial Drug Rebate Reform Final Rule

Before the COVID-19 pandemic derailed even the best-laid plans, the Trump Administration and Congress were focused on a different public health issue: drug pricing. For years, President Trump has targeted “Big Pharma” as...more

Hogan Lovells

Trump Administration revives rebate safe harbor rule in late effort to reform drug pricing

Hogan Lovells on

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more

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