About The Position

Join Cleveland Clinic’s Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world. As a Research Medicare Coverage Analysis Specialist, you will be responsible for determining qualifying clinical trial status and performing detailed coverage analyses in accordance with National Coverage Decision NCD310.1 and the Federal Clinical Trials Policy. In this role, you will report to the Director of Research Medicare Coverage Analysis and ensure compliant research billing practices by reviewing clinical trial protocols and regulatory documents to assess all patient care items and services required per the study, as well as determine the final billing designation for all procedures within a clinical research project. This position is part of a brand-new department at the Cleveland Clinic and offers the opportunity to work as a team member providing Medicare Coverage Analysis for a variety of research projects across the enterprise. The role will establish the centralized MCA Office to ensure billing compliance, protect the organization and patients, and improve operational efficiency. This role is critical to achieving these goals, standardizing processes, and safeguarding Cleveland Clinic’s reputation and financial stability. It is also essential to mitigate the risks of improper billing in clinical trials, which can lead to significant fines, penalties, reputational damage, and exclusion from federal programs. We have three openings for this position. A caregiver in this position works a hybrid schedule from 8:00 a.m. – 5:00 p.m., working two to three days per week remotely and on-site at Main Campus for the remaining days.

Requirements

  • Bachelor’s degree in Healthcare Administration, Medical Coding, Auditing, Finance, Accounting, Nursing or a related field
  • In lieu of degree, six years of relevant experience in research billing, compliance, and/or direct involvement with sponsored clinical trials
  • Four years of relevant experience in research billing, compliance, and/or direct involvement with sponsored clinical trials
  • Ability to interpret and comprehend complex clinical research protocols, interpret research contracts, study budgets and consent forms to extrapolate billing/coverage data
  • Strong organizational skills with ability to multi-task

Nice To Haves

  • Coding or Research experience
  • Ability to navigate the CMS website to determine local and national coverage decisions
  • Scientific or healthcare background (i.e. Billing or clinical trials)

Responsibilities

  • Make determinations of qualifying clinical trial status and perform detailed coverage analysis as required by NCD 310.1 and the Federal Clinical Trials Policy.
  • Ensure compliant research billing practices are followed by reviewing clinical trial protocols, related regulatory documents, clinical trial agreements, informed consent documents, documents from the FDA and CMS, and the study budget to assess all patient care items and services per the study protocol.
  • Research and apply policies from various sources such as federal, state, CMS website and professional practice guidelines in making coverage determinations.
  • Document justification for coverage analysis by citing specific resources for coverage determinations.
  • Assist in the management of claims review by applying the appropriate CDM and/or CPT codes for potentially billable items and services as well as identifying items and services that are billable to the research sponsor.
  • Collaborate and communicate effectively with the Principal Investigator and research team, patient financial services, clinical research billing office, IRB and research compliance related to Medicare coverage analysis issues and determinations.
  • Keep current on FDA and Medicare regulations and state laws that apply to clinical trials for research billing.
  • Assist the MCA Director on the development of tools and billing grids for the Medicare Coverage Analysis process.
  • Other duties as assigned.
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