Cathy Kelly

Bethesda

Senior Writer at The Pink Sheet

Senior Editor at Informa

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Articles

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

1 week ago | insights.citeline.com | Cathy Kelly

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget PlanThe preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection. Preliminary OMB plan offers insights into Administration plans and priorities for 2026. (Shutterstock)
Medicare Price Negotiation: Trump Order Adds Momentum To ‘Pill Penalty’ Fix

1 week ago | insights.citeline.com | Cathy Kelly

Medicare Price Negotiation: Trump Order Adds Momentum To ‘Pill Penalty’ FixWide-ranging executive order to lower drug prices also hints at changes in upcoming guidance on the Medicare price negotiation program but few other potentially impactful near-term actions. 'Pill penalty' undercuts incentives for developing treatments like oral cancer agents, pharma says. (Shutterstock)
GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

2 weeks ago | insights.citeline.com | Cathy Kelly

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare 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. Obesity drugs will not receive the required access in government sponsored insurance ... yet. (Shutterstock)
New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says

2 weeks ago | insights.citeline.com | Cathy Kelly

New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says 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. Blum said the next phase of the price negotiation program will include revisions. (Shutterstock)
Lilly Targets Sale Of Repackaged, Redosed Zepbound, Mounjaro In Lawsuit

2 weeks ago | insights.citeline.com | Cathy Kelly

Lilly Targets Sale Of Repackaged, Redosed Zepbound, Mounjaro In LawsuitEli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products. Lilly requested a court order to shut down a dose-splitting operation. (Shutterstock)
Dr. Oz Takes The Over CMS Amid Major Transformation Of Medicare Part D

3 weeks ago | insights.citeline.com | Cathy Kelly

Dr. Oz Takes The Over CMS Amid Major Transformation Of Medicare Part D As CMS administrator, Mehmet Oz will oversee the second year of Medicare drug price negotiations and Part D redesign issues, but will have experienced deputies to help. The Senate voted along party lines to confirm Oz as CMS administrator. (Shutterstock)
HHS Has ‘Utterly Failed,’ Kennedy Advisor Argues

3 weeks ago | insights.citeline.com | Cathy Kelly

HHS Has ‘Utterly Failed,’ Kennedy Advisor ArguesCalley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders. (Studio Dream/Shutterstock)
Dramatic HHS Layoffs A Response To ‘Existential Crisis,’ Kennedy Advisor Argues

3 weeks ago | insights.citeline.com | Cathy Kelly

Dramatic HHS Layoffs A Response To ‘Existential Crisis,’ Kennedy Advisor Argues Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders. Calley Means said critics should try some 'humility' and consider that voters wanted Kennedy to disrupt the health care system. (Shutterstock)
Think Tank Suggests CMS, USTR Could Enforce Most Favored Nation, Other Drug Pricing Policies

4 weeks ago | insights.citeline.com | Cathy Kelly

Think Tank Suggests CMS, USTR Could Enforce Most Favored Nation, Other Drug Pricing Policies A Republican think tank suggested variations of the Most Favored Nation and international reference policies in Medicare and Medicaid, as well as tariffs and other trade levers to rebalance drug pricing disparities between US countries and abroad. The policy proposals fit with the Trump Administration's focus on costs and tariffs. (Shutterstock)
CMS Nominee Oz Nears Confirmation Despite Concerns About Medicaid Cuts

1 month ago | insights.citeline.com | Cathy Kelly

CMS Nominee Oz Nears Confirmation Despite Concerns About Medicaid CutsDemocrats opposed the nomination because they believe Mehmet Oz will not defend Medicaid from spending cuts. His pledge to continue lowering drug costs in Medicare and Medicaid did not offset the concerns. Mehmet Oz seems likely to be confirmed as CMS administrator after the Finance Committee moved the nomination to the full Senate. (Shutterstock)