Cathy has covered US regulation and reimbursement policy for the biopharma industry since 2004, starting with the establishment of the Medicare Part D program. Since then, she has written extensively about developments in all major sectors of the US insurance market (Medicare, Medicaid and commercial plans). She has covered key legislation affecting biopharma, including the Medicare Prescription Drug, Improvement, and Modernization Act which created Part D, health care reform under President Obama, and the Inflation Reduction Act which establishes a government price negotiation program in Medicare for the first time and redesigns of the Part D benefit.
She has closely followed the increasing influence of pharmacy benefit managers and their use of formulary negotiations and rebates to control pricing. Cathy also has covered developments in health technology assessments, including the growing influence of the Institute for Clinical and Economic Review, and has monitored industry progress on novel drug contracting that reflects value-based pricing.
She has worked as a health care reporter and editor while raising three daughters. Cathy lives outside DC in Bethesda, MD, with her husband Sean.
Latest From Cathy Kelly
Bills to narrow the Medicare price negotiation program’s reach generated extensive discussion at the hearing.
As further details emerge, questions continue about whether the CMMI model could delay access to Lyfgenia and Casgevy; states will be added on ‘rolling basis.’ A new administration could change or cancel the model, but a CMS official predicts that is unlikely.
As FDA decision on Alzheimer’s product approaches, new paper outlines Lilly’s arguments for unfettered Medicare coverage for donanemab once it is approved.
Lilly wants White House Office of Management and Budget to delay final rule until there are regulatory controls against duplicate and diverted discounts. OMB has also held three meetings over past few months with organizations representing 340B providers.
West Texas District Court dismisses lawsuit against Medicare price negotiation program on jurisdictional grounds without considering the merits of the case. PhRMA is weighing next steps.
HHS Secretary Becerra challenges the commercial price Pfizer chose for its COVID-19 therapeutic as the government transitions from being the primary US customer for the drug.