Clinical Trials Research Coverage Analyst - Research Billing Support - 100% Remote

Rush International Ltd. - Chicago, IL

Full-time - Entry Level

Remote - Chicago, IL

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About the position

The Clinical Trials Research Coverage Analyst will support the Research Billing department at RUSH University Medical Center by creating coverage analyses in accordance with Medicare's Clinical Trial Policy. This role involves assisting research staff with the interpretation of guidance related to research billing processes, ensuring compliance with regulations, and providing professional support for Medicare Coverage Analysis for clinical research studies.

Responsibilities

• 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.
• 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.
• 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.
• 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.

Requirements

• 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.
• Proficiency with medical terminology as well as medical research billing language.
• 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.
• Strong time management and organizational skills with the ability to effectively multi-task and meet deadlines.
• Strong problem solving and financial analytical skills.

Nice-to-haves

• Familiarity with different types of clinical research and the drug development process.
• Understanding of FDA regulations related to clinical trials involving Investigational New Drugs (INDs) and/or Investigational 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.

Benefits

• Equal opportunity employer
• Supportive work environment
• Professional development opportunities