Medical Technology Compliance: FDA, AKS, FCA and Other Regulatory Requirements PDF
Preview Medical Technology Compliance: FDA, AKS, FCA and Other Regulatory Requirements
Presenting a live 90-minute webinar with interactive Q&A Medical Technology Compliance: FDA, AKS, FCA and Other Regulatory Requirements Mitigating Medical Device and Healthcare Technology Risks WEDNESDAY, SEPTEMBER 6, 2017 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: Jana Gerken, J.D., Co-Founder and Chief Legal Strategist, Kinetic Compliance Solutions, Milwaukee Ethan E. Rii, Shareholder, Vedder Price, Chicago The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10. Tips for Optimal Quality FOR LIVE EVENT ONLY Sound Quality If you are listening via your computer speakers, please note that the quality of your sound will vary depending on the speed and quality of your internet connection. If the sound quality is not satisfactory, you may listen via the phone: dial 1-866-927-5568 and enter your PIN when prompted. Otherwise, please send us a chat or e-mail [email protected] immediately so we can address the problem. If you dialed in and have any difficulties during the call, press *0 for assistance. Viewing Quality To maximize your screen, press the F11 key on your keyboard. To exit full screen, press the F11 key again. Continuing Education Credits FOR LIVE EVENT ONLY In order for us to process your continuing education credit, you must confirm your participation in this webinar by completing and submitting the Attendance Affirmation/Evaluation after the webinar. A link to the Attendance Affirmation/Evaluation will be in the thank you email that you will receive immediately following the program. For additional information about continuing education, call us at 1-800-926-7926 ext. 35. Program Materials FOR LIVE EVENT ONLY If you have not printed the conference materials for this program, please complete the following steps: • Click on the ^ symbol next to “Conference Materials” in the middle of the left- hand column on your screen. • Click on the tab labeled “Handouts” that appears, and there you will see a PDF of the slides for today's program. • Double click on the PDF and a separate page will open. • Print the slides by clicking on the printer icon. MEDICAL TECHNOLOGY COMPLIANCE: MITIGATING MEDICAL DEVICE AND HEALTHCARE TECHNOLOGY RISK Jana Gerken, Esq. Ethan E. Rii, Esq. [email protected] [email protected] AGENDA • Unique Risk Profile • Key Enforcers • Key Regulations • Case Study - Olympus • Key Elements - Effective Compliance Program • External Investigations / Remediation 6 UNIQUE RISK PROFILE • Constantly Evolving Regulatory Landscape • Multiple enforcement agencies and layers of regulatory requirements • Continuous need to evolve tech-wise • Vigorous competition from many sides (cheaper, faster, better) 7 KEY ENFORCERS HHS-OIG DOJ Medical Tech Company FTC FBI Whistleblower Courts Competitors States 8 KEY REGULATIONS • False Claims Act • Anti-Kickback Statute • Food, Drug and Cosmetic Act • Federal Trade Commission Act • Physician Payments Sunshine Act • Health Insurance Portability and Accountability Act (HIPAA) • Civil Monetary Penalties Statute • State Statutes 9 FALSE CLAIMS ACT • Civil War-era statute to combat military contractor fraud • Prohibits anyone from knowingly submitting or causing to be submitted a false claim for payment to the Government (note: need not be fraudulent) • Whistle-Blower Actions: Under Qui Tam provisions, private individuals (relators) may file enforcement actions on behalf of Government; entitled to 15% - 30% of successful recovery • 2016: $4.7 billion + recovered in settlements and judgments by DOJ; $2.5 billion of that from health care industry Penalties: • Civil: Treble Government’s damages plus $10,781.40 and $21,562.80 per claim • Other: Potential program suspension, debarment and exclusion 10
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