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
The other seven drugs on the initial list for negotiation are already heavily rebated and CMS could choose not to go much lower than current net prices, SSR Health report points out.
There was lots of criticism of pharmacy benefit managers (and a fair amount of pharmaceutical manufacturers) at the oversight hearing. However, Democrats may be more cautious about preserving the benefits PBMs provide versus the downsides in developing reforms.
New GAO recommendations springing from recent Medicare Part D cost and access trends related to rebates may not be relevant going forward because the IRA price negotiation program and benefit redesign will significantly change the landscape, HHS says.
CMS has not disclosed how many requests for the exception it received but will follow up with applicants regarding its decisions this month.
Dora Hughes’ predecessor, Lee Fleisher, has joined the Duke Margolis Center for Health Policy as a visiting fellow.
Some drugs recorded significant increases in Medicare gross spending between the periods covered by publicly available data and what CMS had access to internally, which contributed to their unexpected presence on the list.