Clinical Trials Research Coverage Analyst

3 weeks ago

Remote, United States Axelon Services Corporation Full time
Reporting to the Director/Manager of Clinical Trials Research Revenue Cycle, this position will create coverage analyses in accordance with Medicare's Clinical Trial Policy (NCD 310.1) and assist research staff within the clinical departments with the interpretation of related guidance and their effect on research billing processes. The analyst will provide high-level professional support in the growing efforts to conduct prospective Medicare Coverage Analysis for all clinical research studies.

  • Maintain a detailed understanding of Medicare's Clinical Trial Policy (NCD 310.1) and related guidance documents.
  • Generate detailed and accurate coverage analyses with budget overlay in a timely manner.
  • Review clinical trial protocols and related regulatory documents to prepare a billing plan for all medical procedures and services required in a clinical research project.
  • Review clinical research protocols and determine which procedures are routine, and therefore billable to Medicare and other third-party payers based on CMS policy and National and Local Coverage Determinations, as well as professional practice guidelines. Extensive independent research to identify applicable practice guidelines will be required.
  • Review 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.
  • Ensure consistency of the payment terms in the coverage analysis with the protocol, the informed consent form template, the budget and the contract payment terms.
  • Completely and effectively document MCA determinations to support the decision-making process.
  • Screen 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.
  • Coordinate with IRB staff and the investigator if the IRB raises issues regarding the determinations of the Medicare Coverage Analysis and/or consent form language.
  • Collaborate and communicate effectively with investigators and research staff, Patient Financial Services, the IRB, and Research Compliance with respect to Medicare Coverage Analysis issues and determinations.
  • Keep current with FDA and Medicare regulations and state laws applicable to clinical research billing.
  • Conduct special department related projects as they are assigned.
  • Prepare applications for approval of billing for investigational devices.
  • Serve as a resource for protocol and budget development and overlay.
  • Provide staffing and supply/service consumption patterns, the methods used to estimate/calculate (including escalation or inflation factors) and other details such as lists of items that make up the total costs for a category. The budget justification should address each of major cost categories (salaries, fringe benefits, equipment, travel, supplies, other direct costs and indirect costs), as well as any additional categories required by the sponsor as related to research budget overlay.
  • Organize the budget justification listing items in the same order and format as the sponsor s budget categories.
  • Check validity of all draft and finalized documents prior to calendar release. The Budget narrative must match the budget in terms of dollar amounts and language.
  • Explain why items are essential in relation to the aims and methodology of the project as well as meeting the goals of the project.
  • Understand and describe the line items to clinical study team as necessary. Do not merely restate the proposed expenditure.
  • Provide detail that is sufficient to justify the rationale for the budget overlay.


Required Job Qualifications: Knowledge, Skills and Abilities:
Experience/Qualifications/ Competencies:
  • Bachelor's Degree in a health-related discipline, e.g. pharmacology, nursing, biology.
  • One to five years of coding experience or equivalent work experience
  • AAPC or AHIMA certification in coding within one year of hire with experience in research medical billing and coding. Certifications may include Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder (CMC), and any other specialized coding certification approved by the two main governing bodies.
  • Proficiency with medical terminology as well as medical research billing language. Must demonstrate a thorough knowledge of the three code sets that are currently in use: Current Procedural Terminology (CPT), ICD-10-CM, and Healthcare Common Procedure Coding System (HCPCS) Level II.
    • Excellent written and oral communication skills.
  • Strong investigative skills.
  • Proficiency with MS Excel tables, formatting and basic calculations.
  • Demonstrated resourcefulness and attention to detail.
  • Able to work in a team environment and maintain a positive outlook.
  • Able to learn and apply technical knowledge in the areas of clinical research, medical coding and revenue cycle in a consultative manner.
  • Excellent verbal and written communication skills due to direct interaction with senior management.
  • Strong time management and organizational skills with the ability to effectively multi-task and meet deadlines.
  • Strong problem solving and financial analytical skills. High degree of accuracy for analyses and processes.
  • Must have a strong customer service focus.

Preferred Job Qualifications:
  • Familiarity with different types of clinical research and the drug development process.
  • Understanding of FDA regulations related to clinical trials involving lnvestigational New Drugs (INDs) and/or lnvestigational Device Exemptions (IDEs).
  • Knowledge of Medicare coverage decisions, benefit policy manuals and billing processes.
  • Previous experience in Research Billing, Budgeting/ budgeting analysis for Research Clinical Trials, Coverage Analysis, or other Research Finance background.

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