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Webinar:

Regulatory Issues Update: What Pharmacists Need to Know

As the future of health care reform remains in flux, The Department of Health and Human Services continues to develop rules and regulations that impact on pharmacy practice. Medicare reimbursements under Part B and the status of the National Drug Code reporting requirement at the Centers for Medicare and Medicaid Services, and the Food and Drug Administration's implementation of its new Risk Evaluation and Mitigation Strategy (REMS) authority, are some of the issues being addressed by the Department of Health and Human Services one year into the new administration. A discussion of these and other regulatory issues relevant to health-system pharmacy practice will be discussed.

This presentation is about 30 minutes in length.

Speaker

Justine Coffey, JD, LLM
Director, Federal Regulatory Affairs
American Society of Health-System Pharmacists
Government Affairs Division

Justine Coffey has worked as the director of federal regulatory affairs for the American Society of Health-System Pharmacists since March, 2007. In this position, she advocates ASHP’s positions before federal agencies whose regulatory and rulemaking authority impacts on health-system pharmacy, including the Centers for Medicare and Medicaid Services and the Food and Drug Administration.

Previously, Ms. Coffey worked as a consultant, providing health policy consulting services to individual clients and advising state government agencies on federal and state laws, regulations, and policies impacting on Medicaid and other state programs. From 2002 to 2005, she worked for the American Pharmacists Association, first as a policy and regulatory writer, and then as a senior policy analyst handling 340B Drug Pricing Program issues for the HRSA Pharmacy Services Support Center. Ms. Coffey received her JD degree from American University’s Washington College of Law and her LLM degree from the Georgetown University Law Center.

Learning Objectives and Major Content Areas

1. Describe three regulatory issues of concern to health-system pharmacists recently addressed by the Centers for Medicare and Medicaid Services and/or the Food and Drug Administration
2. Explain the elements that may be included in a Risk Evaluation and Mitigation Strategy
3. Describe the status of the Centers for Medicare and Medicaid Services' National Drug Code reporting requirement