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
A US lawmaker described program reform goals as returning the program to its original focus on supporting federally qualified health centers and rural hospitals.
Although the legislation has little chance of passing, it offers some clues about the administration's goals for MFN agreements, which differ from the voluntary deals struck with large pharma companies.
CMS also outlined eligibility criteria for patients with a body mass index of 27, 30 and 35 or more for the demonstration project planned in Medicare and Medicaid.
The program could increase the momentum for establishing a new model for employer-sponsored insurance coverage.
The FDA final rule gives stakeholders seven years to implement the changes, extending the five years previously proposed, but industry wanted more than a three-year transition period after the effective date.
The agency may be prepared to discuss broader voluntary Most Favored Nation agreements with small and mid-size firms during April meetings about the GENEROUS model.