Cathy Kelly
Senior Writer
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
Medicare Part B Inflation Rebate List Doubles For Third Quarter, Adds Several Amgen Drugs
Amgen's Prolia appears to be the biggest drug on the list of products incurring price inflation penalties in Part B; many of the others have relatively low sales to Medicare.
Merck Suit Against Medicare: Constitutional Arguments Are Scathing, But Are They Persuasive?
A suit designed to test the limits of the protections against judicial review that are embedded in the IRA could have more traction, some legal scholars suggest.
FDA, Medicare And The Future Of Coverage With Evidence Development For Accelerated Approvals
Health policy experts discuss ways Medicare coverage policy may evolve in the coming years and how efforts to smooth the transition between accelerated drug approvals and Medicare reimbursement decisions could play out.
Medicare Registry Plan For Alzheimer’s Drugs Pairs CMS Web Portal With Health System Efforts
Lack of detail on data elements that would be required through the portal has stakeholders wondering if the Centers for Medicare and Medicaid Services has really found a way to make the registry requirement less of a threat to access for Alzheimer’s drugs with traditional FDA approval.
Janssen 340B Discount Growth Slowed In 2022 But Still Topped $6bn; Patient Assistance Jumps 24%
Janssen continues to pursue aggressive policies to reduce inappropriate use of 340B discounts. Firm estimates that 58% of list prices went to commercial and government insurers, 340B providers and others in the US health care system in the form of price concessions last year.
Medicaid ‘Price Verification’ Audit Proposal Aims To Promote Cell, Gene Therapy Rebate Concessions
CMS proposed rule impact may be ‘modest’ but is framed as ensuring patient access to cutting edge treatments by helping to control Medicaid spending. Biden administration initiative also aims to address misclassification of brand drugs, duplicative 340B discounts, and PBM spread pricing.