- Duarte, CA
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers that develops and institutes standards of care for cancer treatment.
City of Hope Coverage Analysts are charged with ensuring that incremental costs of clinical research are covered per institutional policy and guidelines while applying clinical research billing compliance expertise pertaining to all applicable payers.
In general, a Coverage Analyst is expected to coordinate and oversee the development of “billing grids” for both industry sponsored and non-industry sponsored clinical trials. Works with inter- and intra- departmental staff to obtain clinical trial documentation, prioritize work queues, and generally assist with the study start-up process. Liaises between Budget Administrators, study teams, and Protocol Content Administrators to determine suitable charge designations for unique clinical trial procedures, items, and services as part of each Coverage Analysis Billing Grid. Further develops billing grids by confirming procedural codes and outlining coverage guidance as provided by third party payers (Medicare, MediCal, etc). Effectively uses the Medicare Clinical Trial Policy to formulate reasonable assumptions for coverage based on trial types and their respective qualifying statuses. Regularly researches CMS Local and National Coverage Determinations, non-CMS coverage guidance documentation, and claims denial reports from City of Hope Revenue Cycle offices to complete each analysis, as needed. Tracks all relevant data and ensures that budgeting, contracting, protocol content development, and patient finance groups are supplied with finalized documentation.
Provides day-to-day administrative support to Principal Investigators, study team members, clinical trial administrators, departmental business directors and other stakeholders in resolving coverage issues as they relate to clinical research at City of Hope. Continues the general development and ongoing refinement of administrative infrastructure for the management of financial activity associated with for-profit corporate sponsorship as well as non-industry submissions pertaining to clinical trials. The position also integrates diverse elements of clinical trial management and requires creativity, teamwork, and collegiality to develop and maintain sound fiscal and related administrative systems.
Key Responsibilities include:
- Coordinate with all relevant groups to finalize and gain approval of coverage analyses while tracking all appropriate data metrics.
- Understand the clinical trial protocol and corresponding procedures as they pertain to coding while formulating strong coverage guidance to review with PIs as needed
- Obtain approval following Quality Assurance review of each Coverage Analysis drafted
- Ensure consistency between a drafted billing grid and any system that represents a protocol’s treatment schedule or calendar, including but not limited to Clinical Trials Management and Electronic Medical Record systems
- Review protocol amendments for any revisions affecting the original or subsequently amended coverage analysis; update documents as necessary and ensure appropriate follow-up with budgeting, contracting, calendar building, and/or order entry teams.
- Assist Budget Administrators in interacting with sponsor officials to solve budget issues such as those resulting from unexpected non-coverage of a protocols required items and services.
- Analyze new protocols, letters of intent, synopses, etc., received from sponsors, review committees or PI/study teams to determine coverage analysis necessity and/or prioritization in coordination with the Director of CTSS.
- Review study protocols for coverage, financial, and resource feasibility. Carry out periodic reviews of study files to ensure administrative quality, compliance, and consistency across clinical trials
- Assist with ongoing review of internal processes to streamline roles and responsibilities; execute process changes or identify resources to accomplish projects and oversee to completion.
- Prepare reports and advise on feasibility and cost effectiveness.
- Participate in the development of new data systems and tools for electronic clinical trials, financing, documentation, and administration.
- Participate on administrative committees as requested to improve the administrative understanding and support of clinical trials. Represent City of Hope at national and regional professional meetings as necessary.
- Maintain general knowledge of research subjects and research personnel protections.
- Conduct special projects and perform additional duties as assigned by the Director.
- Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
- Performs other related duties as assigned or requested.
Basic education, experience and skills required for consideration:
- Bachelor’s Degree or equivalent combination of education and experience.
- Two years of experience working in research administration, a Contract Research Organization, pharma or biotech industry, a medical or clinical practice arena, or health insurance industry
- Must have working knowledge of clinical trials
- Must be familiar with HCPCS / CPT, DRG coding
- Must understand what is typically considered standard of care or routine care and what is considered research-related in the context of a clinical trial
- Must be familiar with Medicare regulations, guidelines, policies (especially the CMS Clinical Trial Policy, also known as NCD 310.1) as they pertain to clinical research billing
- Working knowledge of CAR T processes / therapies and other immunotherapy processes is desirable
- Must have analytical skills to develop and review coverage analyses and clinical trial documentation based on established criteria and departmental guidelines
- Must have research skills to review large amounts of coverage guidance from multiple sources, with the ability to apply information appropriately and efficiently to each billing grid developed
- Must have excellent interpersonal skills to deal with complex, sensitive, and confidential material with Principal Investigators, sponsors, and administrative and management personnel
- Must be able to manage multiple competing demands
- Must be able to proactively negotiate priorities
- Must demonstrate consistent and successful follow through on issues and problems
- Understanding of Institutional Review Board purposes and requirements
- Knowledge of Clinical Research Finance and/or Revenue Cycle operations (specifically claims processing workflows and procedures)
- Must have excellent written and oral communication skills
- Must have ability to work independently while still serving as a member of a professional team
- Demonstrate strong attention to detail
- Must be able to proofread documents
- Must be able to research information
- Coding (HCPCS/CPT; DRG); related to Oncology to a plus
- Experience budgeting and estimating clinical trials costs is a plus
- Experience in an academic research environment
- Knowledge of Good Clinical Practice Guidelines, ICH Guidelines, FDA and HIPAA regulations, Medicare Clinical Trial Policy
- Knowledge of common budgeting practices and general time/effort allotments is a plus
- Clinical trial coverage analysis development; clinical trial billing and/or clinical trial billing compliance
- Clinical Research Coordination and/or Nursing
- Certified Clinical Research Coordination (CCRC)
- Certified Clinical Research Associate (CCRA)
- Registered Health Information Administrator (RHIA)
- Registered Health Information Technician (RHIT)
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