CMS Audit Readiness: Proactive Strategies and Practical Solutions

Ned Mumtaz is a pharmaceutical industry veteran with 18+ years of experience. He’s held leadership roles at Schering Plough Research Inc., Wyeth Pharmaceuticals, Eisai Pharmaceuticals, and Otsuka Pharmaceuticals. A trusted consultant to 30+ drug and device manufacturers, Ned leads the compliance analytics practice and is recognized for his contributions to conferences, white papers, and webinars.

With over 20 years in healthcare law and compliance, Heidi Kocher has held key roles, including compliance officer at a DME company, privacy officer at a medical device manufacturer, and legal advisor for hospitals, physician groups, pharmacies, and non-profits. She specializes in compliance and privacy programs, Corporate Integrity Agreements, audits, reimbursement, and aggregate spend reporting under the Sunshine Act. She has also developed compliance programs for FCPA and Eucomed, and defended FDA audits.

Katy Herman is a highly skilled legal professional, providing counsel on a wide range of healthcare compliance matters for drug and device manufacturers. Her primary expertise lies in supporting companies with Medicare and Medicaid billing compliance, where Katy works closely with clients to ensure adherence to the stringent regulations governing reimbursement processes. In addition to billing compliance, Katy is well-versed in Medicare and Medicaid accreditation requirements. She assists clients in meeting the rigorous standards necessary for accreditation, ensuring that healthcare organizations maintain the highest level of quality and adherence to regulatory guidelines.

Amanda Johnston is a distinguished FDA attorney with expertise in counseling medical device and pharmaceutical companies on FDA law, regulatory submissions, healthcare compliance programs, and healthcare fraud and abuse laws. With an impressive background spanning several in-house legal, regulatory, and compliance roles within the medical device industry, Amanda brings an exceptional understanding of business and industry dynamics to her practice. Her extensive experience includes serving as interim compliance officer at a global medical device company, overseeing 130+ FDA submissions, compliance program implementation, and helping commercial teams navigate healthcare fraud and abuse laws.