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IRA Negotiation Changes: Pharma’s Focus Remains On Near-Term Legislative, Regulatory Options

 
• By Cathy Kelly

Manufacturers still hope to advance legislation removing the “pill penalty” from the law, as well as changes they want included in the CMS guidance for the 2028 price implementation year.

Pharma lobbyists are working to implement IRA revisions. (Shutterstock)

Pharma continues to face an uphill battle to remove the so-called “pill penalty” from the Inflation Reduction Act’s Medicare price negotiation program by adding the proposal to the upcoming federal spending bill.

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GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.

New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says

 
• By Cathy Kelly

Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.

Dr. Oz Takes Over CMS Amid Major Transformation Of Medicare Part D

 
• By Cathy Kelly

As CMS administrator, Mehmet Oz will oversee the second cycle of Medicare drug price negotiations and Part D redesign issues, but will have experienced deputies to help.

Dramatic HHS Layoffs A Response To ‘Existential Crisis,’ Kennedy Advisor Argues

 
• By Cathy Kelly

Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.

More from Geography

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.