Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now? – Diagnosing Health Care Podcast
Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more
Since our last edition of the Mintz IRA Update, the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) and related maximum fair price (MFP) negotiation process for each of the 10 high-expenditure...more
The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which aims to lower drug prices by enabling the federal government to negotiate prices for some of the costliest Medicare Part D...more
Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation...more
The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more
In July, the Centers for Medicare & Medicaid Services made significant headway in its implementation of the drug pricing provisions of the Inflation Reduction Act (IRA). How can stakeholders respond to, implement, and comply...more
On May 17, the U.S. District Court for the District of Columbia issued a decision vacating the Accumulator Adjustment Rule, regulations issued by the Centers for Medicare and Medicaid Services (CMS) in December 2020 as part...more
On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more
On 23 December 2020, Judge Catherine Blake of the U.S. District Court for the District of Maryland granted the Pharmaceutical Research and Manufacturers of America (PhRMA) a 14-day nationwide temporary restraining order,...more
Many health care providers treating senior patients rely on Medicare reimbursement and undertake significant measures to ensure proper billing and compliant practices. However, providers across the country may soon be subject...more
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
The shutdown is over for now and Congress is hitting the ground running this week. Most priorities have been on standby with the shutdown taking center stage, so this week in a sense represents the first week of the 116th...more
On October 18, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would require direct-to-consumer (DTC) television advertisements for prescription drugs and biological products for which...more
On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more
In January 2018, in the wake of the publication of the House Energy and Commerce Committee’s Review of the 340B Drug Discount Program, I wrote that it was too soon to know whether 2018 will be a game-changing year for the...more
This week, Congress returns to Washington with 11 days to finalize a government spending bill. House appropriators will be meeting throughout the week to finalize their respective packages which means we should expect to see...more
A Republican White House and a Republican-run Congress could bring significant changes to the 340B Drug Pricing Program (“the 340B program”). Many in Washington believe that the new administration and Republicans in Congress...more
CMS Proposes Bundled Payments for Cardiac Care - In its most recent effort to hasten Medicare’s transformation from a fee-for-service payment model to a value-based payment model, the Centers for Medicare & Medicaid...more
Last week, the Centers for Medicare & Medicaid Services (CMS) and the Pharmaceutical Research and Manufacturers of America (PhRMA) released proposals to address recent criticism over rising drug prices. CMS proposed to...more
This Week: Congress unable to come to agreement on funding the government past Dec. 11 so a short-term funding bill was passed to give more time for negotiations... Tax extenders still being discussed as a vehicle for a...more
In This Issue: - First Guidance following Hobby Lobby released - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives ...more