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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

Medicare Negotiation: Therapeutic Alternatives Selection Will Become More Predictable, CMS Says

The selection process timeline will not change, but as the Medicare price negotiation matures, industry will better understand how therapeutic alternatives are chosen to inform the process, according to an official with the Centers for Medicare and Medicaid Services.

Reimbursement Medicare

Bipartisan House Support Remains Elusive In 340B Reform Effort

Republicans continue to take the lead on advancing reforms, while Democrats warn proposals could endanger a government program supporting safety-net care.

Pricing Debate Legislation

House 340B Reform Bill Would Require Discount Pass Through, Define Patient, Hospital Eligibility

Legislation is the fruit of PhRMA’s lobbying collaboration with the National Association of Community Health Centers. It would also require manufacturers to supply contract pharmacies, within limits.

Pricing Debate Policy

Ophthalmic Drugs Already Lead Medicare Part B Cost Drivers: How Will Gene Therapy Fit?

Gene therapy for wet age-related macular degeneration is one of two later-stage gene therapies flagged in CVS Caremark’s latest pipeline report that are outliers because they target conditions afflicting millions of patients and could dramatically increase Part B spending.

Reimbursement Gene Therapy

Pink Sheet Podcast: Clinical Trial Reg Issues, NIH Drug ‘Access Plans’, Good Ole Days Of Woodcock

Pink Sheet editors discuss the US FDA’s potential regulatory changes to promote novel trial designs, an NIH proposal to better ensure access to a commercialized product, and lawmakers longing for Janet Woodcock's days running the Center for Drug Evaluation and Research.

Clinical Trials Pricing Debate

340B Contract Pharmacy Confusion: Another US Court Sides With Pharma, States Enact Roadblocks

The DC Circuit Court agrees with an earlier appeals court ruling that the law does not prohibit manufacturers from setting the terms of their 340B outpatient drug discounts to contract pharmacies.

Legal Issues Pricing Strategies
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