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Cathy Kelly

Senior Writer

Washington, DC

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

Obesity Drug Coverage In ACA Plans May Expand With Shift In Treatment Classification Standard

Current drug classification standard was originally designed for the Medicare Part D program, which does not cover obesity drugs.

Regulation Reimbursement

Lecanemab Data On Benefit In Alzheimer’s Might Satisfy FDA – But What About Medicare?

Centers for Medicare and Medicaid Services’ standard for determining whether drugs produce a clinically meaningful improvement in cognition that would allow for broader Medicare coverage is unclear. But Eisai/Biogen’s lecanemab is likely to serve as a first test.

Reimbursement Medicare

340B Dispute Resolution Decisions Subject To Administrative Appeal Under Proposal

US Health and Human Services Department revises approach to 340B administrative dispute resolution process and presiding panel in proposed rule.

Legal Issues Medicaid

Medicare Alzheimer’s Coverage Policy Advancing Clinical Trial Diversity Efforts

Medicare national coverage determination for Alzheimer’s drugs has been a ‘game changer’ in terms of motivating industry to boost diversity in clinical studies in the disease, trial expert says.

Diversity & Inclusion Reimbursement

Medicare And Lecanemab: House Republicans Lack ‘Proactive’ Plan For Ensuring Coverage

With a slim House majority, will Republicans wade into Medicare coverage policy for a promising Alzheimer’s drug and the new Medicare price negotiation program? Democratic Senate could offer ‘counter oversight’ hearings.

Elections Reimbursement

Amgen Mvasi, Kanjinti Sales Decline As Biosimilars Industry Faces New Policy Challenges

ASP metric used in Medicare, and often in commercial insurance, for reimbursement of physician-administered drugs is an important factor in the sales arc for biosimilars. Price negotiations under IRA could bring their own margin-squeezing pain to pharmacy-benefit biosimilars.

Biosimilars Reimbursement
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