ASCO helps shape the regulatory framework in which oncologists practice by reviewing and commenting on a wide range of rules, guidelines, and system changes issued by federal agencies, including the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Office of the National Coordinator for Health Information Technology (ONC). In recent months, the society has submitted comments in the following areas:
- FDA’s guidance for the standardization and evaluation of Risk Evaluation and Mitigation Strategies (REMS).
- ONC’s and FDA’s development of a risk-based regulatory framework and strategy for health information technology (HIT).
- CMS’ proposed changes to its Medicare Physician Fee Schedule (MFPS) and Hospital Outpatient Prospective Payment System (HOPPS) for fiscal year 2014. CMS issued both sets of proposed changes in mid-July of this year.
- FDA’s Draft Guidance for Industry on Expedited Programs for Serious Conditions – Drugs and Biologics.
To view the comments and read the latest news on ASCO’s policy and quality efforts, please visit: www.asco.org/advocacy. ■
© 2013. American Society of Clinical Oncology. All rights reserved.
