Center for Improvement in Healthcare Quality Newsletter
May 2022

CIHQ-ARS Article

Conversation with April Rudoni, Corporate Director of Compliance Audits at McLaren Health Article provided by Alan Brander, RN

3.2022 Two Minute Interviews with April Rudoni (a video podcast on Linked In)
“It’s a spiderweb of coordination across many departments. There are no sets of definitive guidelines or device lists, so it requires a lot of concentration, a lot of coordination on a very difficult task. Compliance matters.”
On this episode of Two Minute Interviews video podcasts, Tom Flynn is joined by a 20-year veteran in the healthcare compliance industry. Guest April Rudoni recently completed her latest certification with the American Institute of Healthcare Compliance (AIHC) and is the Corporate Director of Compliance Audits with McLaren Health. Watch and listen to this thoughtful conversation about the OIG and managing warranty credits for explanted medical devices.
  • More than half of 6500 + claims from 911 audited hospitals did not follow CMS requirements for reporting and repaying applicable manufacturer credits for cardiac devices
  • CMS followed the OIG’s recommendations to have Medicare administrative contractors do audits to recover over-payments related to device credits during the look back period
  • CMS required facilities to perform their own six-year look back deep dive self-assessment
  • Processes are like threading a needle but the potential costs or consequences of failure to report are much worse
  • CMS 6037-f Final Rule
  • An organization can address this internally or through consultants (SpendMend)
  • Educate stakeholder departments that hold piece of warranty or device credit puzzle about device credits
  • There may be differences in EMR systems, billing, and IT across the health system or facilities
  • Complete a gap analysis and develop standardized plans and policies for determining whether a credit applies (include manufacturer)
  • Engage legal counsel to ensure appropriate documentation
Legal, Organizational and Compliance Implications:
  • Perform review with vendor consultants, compliance specialist, and/or legal
  • Make sure documents are clear, follow CMS guidance, and prove a process is in place to determine compliance
  • Show how any non-compliance has been corrected – across departments
  • Determine how many explanted device procedures could be impacted (review and analysis) and finalize claims that require repayment
  • Start the repayment clock – 60 days!
  • Determine operational processes, procedures, structures, and oversight within and beyond integral departments and manufacturers
  • Track returned devices and applicable credits
  • Involve accounting, billing, and finance departments to ensure claim adjustments are updated and correct
  • Compliance team monitors process for effective documentation – one workflow or process
  • Legal department supports self-reporting and mitigation
  • Support from leaders across stakeholder departments

Author Bio:

April Rudoni is the Corporate Director of Compliance Audits for McLaren Health Care, headquartered in Grand Blanc, Michigan. McLaren is a fully integrated health care delivery system which includes 15 hospitals in Michigan and Ohio, ambulatory surgery centers, imaging centers, a primary and specialty care employed-physician network, commercial and Medicaid HMOs covering approximately 640,000 lives in Michigan and Indiana, home health, infusion and hospice providers, pharmacy services, a clinical laboratory network and a wholly owned medical malpractice insurance company. McLaren operates Michigan’s largest network of cancer centers and providers, anchored by the Karmanos Cancer Institute, one of only 51 National Cancer Institute-designated comprehensive cancer centers in the U.S.
April has over two years of compliance experience which when the HIPAA Privacy and Security rules were introduced for implementation. Since then, April has served in various compliance roles within the McLaren system, including, Chief Compliance and Privacy Officer at the system’s largest teaching hospital, Medicare Advantage Director (health plan), and now serves as the Compliance Audit Director to guide and oversee audit and monitoring activities which support compliance with documentation, coding and billing guidelines. In 2021, April led a Medicare Cardiac Device Credits 6-year lookback audit for the health system, resulting in significant improvements at applicable hospitals and the many departments involved. April is Certified in Healthcare Compliance (CHC) through the Health Care Compliance Association (HCCA).