We have been engaged by our medical device client to recruit for their Clinical Trial Reimbursement Manager . This role provide s support to internal and external customers for Clinical Trial compensation. The Manager will review protocol and fee schedules to provide guidance regarding clinical trial reimbursement for IDE, PM and any other trial designated for reimbursement. Ensure compensation a nd process adheres to Company standards, policies and compliance. Consults with study sites and Centers for Medicare & Medicaid Services (CMS) coverage policies. This position is located in Plano, TX .
The Manager will be responsible for assisting sites in the appeal process, and other related matters requiring a very specialized knowledge of the Medicare Reimbursement procedures and requirements. Requires interactions with other divisions including corporate reimbursement and executive management and make recommendations regarding reimbursement issues. Previous medical device or pharmaceutical reimbursement experience required.
Impact this role will have within the organization:
Creates Fee Schedules and instructional reimbursement binders for the participating sites for al l studies when indicated.
Performs analyses of Medicare reimbursement rates and financial assessment of Fair Market Values (FMVs) utilized for the budget recommendations of protocol-required clinical study procedures. Prepares complex analysis of budget related issues, including determining the fair market value of the Study Budg et for each new clinical trial.
Provides highly technical assistance to investigational sites with submission of Medicare coverage requests and appeals of Medicare and private insurance coverage denials.
Assists with the development of standardized, study-specific fee agreements to be included with CTA contract templates.
Creates study-specific reimbursement materials and oversees the preparation of Study Reimbursement Binders for distribution to IDE clinical study sites.
Maintains regular, reliable, and predictable attendance. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Participates in policy discussions and provide summary analysis for coverage requirements at national, local, and payer specific coverage.
Assists in tool creation providing technical content for clinical trials, product launch, and other program initiatives.
Performs other essential functions and responsibilities as determined by the Company from time to time.
Remains current on developments in field(s) of expertise, applicable regulatory requirements, and a comprehensive knowledge of the company’s products, markets, and objectives as well as industry trends. Maintains an awareness of, and disseminates information to management and staff on all laws, regulations and nuances that may impact grants & contracts operations by reviewing key literature, trade journals, remaining active in professional associations, and by attending conferences/seminars.
Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
Assist in process improvement across departments to help facilitate better understanding of compliance.
Provide education to internal and external content regarding reimbursement.
Bachelor’s Degree in Business Administration, BS, or an equivalent academic field.
6+ years of analytical experience involving grant and contract requirements, policies, and procedures including, but not limited to: Clinical and AdvaMed Code of Ethics on Interactions with Health Care Professionals.
Demonstrated working knowledge of coding, DRG assignments, APC categorization and process.
Demonstrated knowledge of federal, state and industry rules and regulations governing technical aspects of reimbursement and compliance.
Demonstrated knowledge of the practices/procedures of the function, company polices, and programs.
Comprehensive written and verbal communication, interpersonal, presentation, technical, analytical, statistical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees.
Demonstrates and uses discretion in exercising work assignments and handle sensitive/confidential information in an effective manner.
Demonstrated ability to understand and comply with applicable government regulations and Company operating procedures, pr ocesses, policies, and tasks.
Polished communicator- written documentation and oral presentations/ discussions/ meetings .
Excellent reputation for building relationships across various levels of an organization.
Previous related experience in reimbursement for medical device, biologics, or pharmaceutical company.
Experience preparing and giving presentations.
An advanced degree (i.e., masters and/or doctorate level)
Professional certifications (i.e., Certified Professional Contracts Manager (CPCM), Certified Clinical Research Professional (CCRP), or related certifications)