Coverage Analysis/Itemized Budget
The Principal investigator (“PI”) has the primary responsibility for ensuring the appropriate billing of clinical items, procedures and services required by a research study. The PI must ensure that there is clear and consistent language in the approved protocol, informed consent form (ICF), and the clinical trial agreement(CTA)/budget regarding the responsibility (sponsor or study participant) for research related services and standard of care services (routine costs). A research study must have a budget that accurately and appropriately allocates the costs associated with the performance of the research study to the responsible payer (i.e., a sponsor, grant, internal funding source, or study participant).
In order to ensure costs are allocated to the appropriate entity, the PI or designee must provide an Itemized Study Budget for industry, non-profit, university, federal, or internally sponsored studies, detailing all items, procedures and services required by the research study. Once an itemized study budget is received, a coverage analysis must be performed. PIs are responsible for ensuring that the Coverage Analysis for their studies are completed
When is a Coverage Analysis/Itemized Study Budget Required?
All Human subject research acknowledged by the UIC IRB by designation of a UIC protocol number and which utilize services or resources provided by the University of Illinois Hospital and Clinics, UIC College of Medicine office-based clinics, Mile Square Health Center, or Ryan White Infectious Disease Clinics (this includes both inpatient and outpatient services, including but not limited to ancillary services such as clinic visits, professional medical services, medical supplies, lab, pharmacy services, and imaging, whether for research purposes or standard of care) is required to have a Coverage Analysis and Itemized Study Budget.
What is a Coverage Analysis?
A Coverage Analysis is an independent review of clinical research protocols to determine which clinical tests, procedures and interventions are billable to third-party payers and which are not. It is a systematic review of clinical trial documents (including but not limited to, research protocol, consent document, clinical trial agreement, and budget) published practice guidelines, and billing rules, regulations, and guidance to determine the billing status of each item/service that are required by the clinical research protocol.
Procedure for the Coverage Analysis/Itemized Study Budget Review
- After the research study has been acknowledged by the University of Illinois Institutional Review Board (“UIC IRB”) by designation of a UIC protocol number, the PI or designee is required to submit a completed Coverage Analysis Form, protocol documents/ICF under IRB review, and the draft CTA including an itemized budget to the Clinical Research Finance Office (CRFO) to firstname.lastname@example.org.
- Once the completed coverage analysis form, protocol/ICF documents have been obtained, including the draft CTA/itemized budget, the CRFO will conduct a coverage analysis within 15 business days and provide a Draft Coverage Analysis to the PI or designee.
- If the CRFO determines that a research study is not a qualifying clinical trial, all costs associated with the performance of the research study must be provided for by the sponsor/funding agency or by internal funding. The PI must ensure that all services that cannot be billed to third-party payers are covered by the sponsor/funding agency or internal funds and that the clinical trial agreement clearly identifies the services paid by the sponsor/funding agency.
- The coverage analysis will remain as a draft until a final reconciliation is conducted by the CRFO. The final reconciliation is a review to confirm consistent language is documented in the draft coverage analysis, finalized clinical trial agreement (including the itemized budget), and UIC IRB approved protocol/ICF regarding costs and subject injury. Upon confirmation, the CRFO will distribute a final coverage analysis to the PI or designee and the Office of Sponsored Programs (OSP).
- The finalized coverage analysis will be used by the PI to allocate costs associated with the research study.
- The PI is responsible for ensuring that the study participant is well aware of the procedures and services occurring at each visit, which will be covered by the research study and which will be the responsibility of the research subject and/or his/her insurer using the finalized coverage analysis as the guide.
- The PI will ensure that the final coverage analysis document is maintained with the research study records.
- The coverage analysis document, draft or final, is an internal document and must not be distributed externally.
- If there are any amendments to the protocol which add or remove any items, procedures or services or a change to the itemized budget, the PI or designee is required to revise the Coverage Analysis Form and submit as a revision to email@example.com. The CRFO will issue a revised draft or final (depending on the circumstances) coverage analysis within 15 business days of receipt.
Instructions for Completing Coverage Analysis Forms
Principal Investigators (PI)s are required to submit a Coverage Analysis Form for each research protocol once the study has been submitted to the UIC IRB and an IRB protocol number has been received. This document provides step-by-step instructions for completing the two sections of the Coverage Analysis Form; however, additional assistance can be obtained from Researchfinance@uic.edu
Section 1- Protocol Identifying Information
The first tab of the Coverage Analysis Template “Study Info and Docs, Tab1” gathers specific information regarding the clinical research trial. Only those sections highlighted in yellow need to be completed. Each information item is described in the following table:
Protocol Identifying Information
Information Item Description/Instructions for Completing UIC IRB Protocol # UIC IRB assigned 8-digit protocol number (XXXX-XXXX) Department The name of the department to which the Principal Investigator is assigned. PI Name The name of the physician who is designated as the Principal Investigator on the IRB application for the protocol. Protocol Title Name of the protocol as it appears on the protocol and IRB application. Protocol version and/or date The version and/or date of the latest protocol version submitted to the UIC IRB. ICF version/date and IRB approval date ICF version and/or date of the latest ICF submitted to the UIC IRB. If IRB approval has been obtained, please include the approval date and submit the IRB approved ICF with your submission. Clinical Trial Agreement or Grant version/date or execution date: Clinical Trial Agreement or Grant version/date or execution date: Clinical Trial Agreement or grant execution date or N/A if not yet executed. NCT Number ClinicalTrials.gov registry number. The format for the ClinicalTrials.gov registry number is “NCT” followed by a 9-digit number, e.g.: NCT000000419. Funding Sponsor The name of the funding source regardless of whether it is Federal, Industry, Internal, or Private/Foundation. Study Type Select either “Sponsor Initiated”, “Investigator Initiated” or “Coverage with Evidence Development” Funding Type Select either “Federal”, “Industry”, “Internal”, or “private foundation”. Phase of Study The clinical phase of development of the trial- Phase I – IV. Name of Investigational Drug Insert name of investigational drug or N/A IDE #: Investigational device exemption # or N/A Name of Investigational Device Insert name of investigational device or N/A IDE #: Investigational device exemption # or N/A If this is not an investigational drug or investigational device study, what is the investigational purpose? If the protocol is not an investigational drug or investigational device, identify the investigational portion of the study - what it is the protocol seeks to determine.
Tab 2- “Billing Grid”
The second tab of the Coverage Analysis Form is set up as a worksheet grid and is intended to replicate the study participant services schedule of events in the research protocol and/or informed consent document. It is also used to indicate payment responsibility. Completing this worksheet grid requires a thorough analysis of the protocol and funding, as well as consideration of whether or not the clinical services are medically necessary standard of care and would have been rendered to the patient regardless of enrollment in the research study. It also required knowing to what extent the sponsor is paying for clinical services.
To complete the worksheet grid (sample shown below), the PI is required to replicate or develop the schedule of events using the template headers provided. If there is no schedule of events, itemize protocol services and indicate the interval at which the services will be rendered. Once the grid is developed, each item/service required by the protocol must be analyzed and have the appropriate billing code assigned:
- S=Sponsor is paying for or providing the item or service: No Medicare billing or billing to third party payors for anything being paid for by the Sponsor or being provided by the Sponsor free of charge. An example is the Sponsor providing the investigational drug or device. For purposes of this discussion, a Sponsor could be a Cooperative Group, Pharmaceutical Company, Research Department or Research Site.
- N=Conventional care, routine care: Would be done whether or not the subject is in the study. This item or service may be billed to Medicare and other third party payors. It is the physician’s responsibility to document medical necessity in patient/subject’s medical record.
- E=Effort: This represents research effort only (time and effort for the conduct of the clinical trial). Medicare does not pay for collection of data; therefore, either the Sponsor or site provides funding for these activities.
- CL=Central lab: Typically used when labs are going to a central location and the Sponsor is providing payment for these services.
- NPS= Not part of study: Typically used when the protocol suggests (rather than mandates) that an item be conducted if done per standard of care.
- NB- Not billable: Not billable on its own, billed under another procedure. For example, vital signs are not separately billable but included in the physician exam.
- PS=Patient specific: An activity that may or may not be done for all subjects, or may or may not be billable for all subjects. At the point of service, this will either be an “S”- which means the Sponsor will pay and the item or service cannot be billed to Medicare or other third party payors, or it is an “N”- which means for this subject, this item or service is routine care at this point of time.
- Other Information:
Activities that are done for routine care, but may need to be repeated in order to meet the protocol’s time frame are “PS” patient specific, such as services required at “baseline/ screening” to determine eligibility for the protocol.If an item or service is conducted solely for the clinical trial and it is not routine care (such as testing done at a greater frequency, for example, a CT scan is done every 8 weeks, but the study requires one monthly), Medicare cannot be billed for the monthly CT scan. Alternatively, even though an item or service is considered routine care regardless of the clinical trial, Medicare may not cover the item or service.
- Delete the existing grid and reproduce the schedule of events.
- Assign each item/service a code.
- Provide guideline/industry standard proof for standard of care, if applicable, under ” Comments”
- Submit completed form (including schedule of events with codes assigned) to firstname.lastname@example.org. Please make certain that the IRB protocol number is the subject line of the email.
Medicare Coverage Instructions for Investigational Device Studies
Medicare has covered the cost of certain investigational devices and services incident to investigational device exemption studies (IDE) since November 1, 1995. Effective for Category A and B IDE studies approved by the FDA on or after January 1, 2015, the request for and approval of the costs associated with the study should occur directly with CMS (local Medicare contractor approval no longer required). Information regarding how to request coverage and IDE studies that have CMS-approval may be found at the CMS Coverage Website: https://www.cms.gov/Medicare/Coverage/IDE/index.html
The following CMS checklist document may assist sponsor-investigators conducting Category A or B IDE studies with their submission to CMS.
Once approval is received from CMS, our Medicare Contractor, NGS, Inc., requires that the CMS approval letter and billing provider number be sent to: NGSIDERequests@anthem.com. Please include email@example.com on all email communications to NGS, Inc.