The FDA recently released a proposed rule, which it characterized as “landmark policy changes,” that would amend the regulations at 21 C.F.R. Part 900 issued under the Mammography Quality Standards Act (MQSA) for the first time since 2002. If finalized, the amended rule would impose extensive new compliance requirements on all facilities across the United States that perform screening and diagnostic mammography studies, except facilities under the jurisdiction of the Department of Veterans Affairs. The proposed rule would also enhance FDA’s oversight of mammography facilities and broaden the scope of its enforcement actions. We anticipate that many facilities and device manufacturers will choose to submit written comments for this proposed rule on or before June 26, 2019. This webinar will:
- Provide an overview of the key changes in the proposed rule;
- Discuss the proposed new requirements for categorization and disclosure of mammography findings, including the information that must be communicated to the patient and healthcare provider about breast density and cancer risk;
- Address the impact on medical outcomes audits conducted by the facility, as well as inspection, accreditation, and certification of mammography facilities;
- Clarify the implications for CMS reimbursement of mammography procedures for Medicare and Medicaid beneficiaries, including the potential increase in supplementary screening procedures if the proposed rule is finalized;
- Identify the proposed additions to FDA’s enforcement toolbox for violations, including direct notifications by the Agency to patients and their healthcare providers; and
- Explore the compliance and risk management implications for healthcare facilities with mammography programs.
Thursday, May 16, 2019
1:00 P.M. – 2:15 P.M. ET
CLE credit will be applied for in CA, GA, IL, NY, TX and, if needed, NC and VA. Attendees will receive a Uniform Certificate of Attendance via email approximately 30 days after the program to seek CLE credit in other jurisdictions. New York lawyers: This program is considered transitional and non-transitional in content. The interactive webinar format is synchronous and approved for all lawyers. King & Spalding LLP / 1180 Peachtree Street, Atlanta, GA 30309 | CA Provider # 10947.
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