• Screening research protocols to determine whether a formal Medicare Coverage Analysis (MCA) is required.
• Collaborate with investigators to determine whether each study is a qualifying clinical trial under CMS Clinical Trial policy.
• Based on CMS policy and National and Local Coverage Determinations, as well as professional practice guidelines, reviews clinical research protocols and determines which procedures are routine, and therefore, billable to Medicare and other third party payers. This often requires extensive independent research to identify applicable practice guidelines. This also requires the incumbent to be cognizant of changes related to the CMS interpretations and implementation of its policies, which have been controversial.
• Completely and effectively documents MCA determinations to support the decision-making process. This documentation may be subject to inspection by CMS and regulatory agencies.
• Reviews patient informed consent forms to ensure that the document accurately informs patients which procedures will be billed to their insurance vs. those that will be covered by the study budget, in accordance with the MCA.
• Provide training and consultation to investigators and research staff and managers on regulations and policies related to Medicare coverage in research. Also provides consultation in the development of investigator-initiated protocols with respect to implications for Medicare billing.
• Collaborate and communicate effectively with investigators and research staff, Patient Financial Services, IRB and Chief Compliance Officer with respect to Medicare Coverage Analysis issues and determinations.
• Assist with the development of institutional policies and procedures pertaining to clinical research budgeting and billing, including the MCA process.
• Keep current with FDA and Medicare regulations and CA state laws applicable to clinical research billing.
• Conduct special department related projects as they are assigned.

#Jobs#Jobs-NHCN#Jobs-HERC