The CMS National Coverage Decision for Routine Costs in ...



Medicare Cost Analysis – Documentation of Research Billing Review FormStudy Name: __________________________________________________________Sponsor: _____________________________________________________________National Clinical Trial (NCT) Number (if study given one):_____________________Investigational Device Exemption (IDE) Number (if applicable): ________________Principal Investigator: __________________________________________________Research Coordinator: __________________________________________________*If NCT number is already assigned, skip "Section A" and go directly to "Section B" ****************************************************************************************************Coverage Analysis GuidelinesIn order to bill Medicare for items or services related to a clinical trial, a clinical trial must meet certain criteria. For drug studies, Medicare outlines three requirements and seven desirable characteristics that a trial must have in order to be a qualified clinical trial. Some trials are presumed to have the seven desirable characteristics and are automatically qualified (if they also satisfy the three requirements) to receive Medicare coverage if they are funded by certain federal agencies or have an IND or IND exemption. Additionally, federal regulations permit certain items and services provided in device studies to be billed to Medicare. For device studies under an IDE (category B), prior approval from Medicare Part A and Part B is required.Section A: Qualifying Clinical Trial Determination – Questions ChecklistIs the subject or purpose of this trial an evaluation of an item or service that falls within a Medicare benefit category? __ Yes __ NoDoes the trial have therapeutic intent? __ Yes __ NoDoes the trial enroll patients with a diagnosed disease? __ Yes __ NoDo any of the following apply to this study? ___ Yes ___ No If Yes, circle one of the following.Trials funded by NIH, CDC, AHRQ, HCFA, OD and VATrials supported by centers or cooperative groups that are funded by the federal agencies listed above in (a)Trials conducted under an IND reviewed by the FDA Drug trials exempt from having an IND under 21 CFR 312.2(b)(1) Device Clinical Trial (IDE)If you answered “Yes” to Questions 1, 2, 3 and 4 above, go to Section B of this MCA Form.If you answered “No” to any Question above, please answer question #5.Does this study satisfy the following characteristics?The principal purpose of the trial is to test whether the intervention potentially improves participants’ health outcomes. __ Yes __ NoThe trial is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use. __ Yes __ NoThe trial does not unjustifiably duplicate existing studies. __ Yes __NoThe trial design is appropriate to answer the research question being asked in the trial. __ Yes __ NoThe trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully. __Yes __ NoThe trial is in compliance with Federal regulations relating to the protection of human subjects. __Yes __ NoAll aspects of the trial are conducted accordingly to the appropriate standards of scientific integrity. __Yes __ NoIf you answered "No" to any item in Question 5, this study is not a "qualified clinical trial" and Medicare cannot be billed for research items or services relating to the study. Stop and do not complete any other portions of this MCA Form.Section B: Schedule of Events Billing WorksheetThe CMS National Coverage Decision for Routine Costs in Clinical Trials allows for coverage of routine costs during a qualifying clinical trial and claims if the beneficiary is treated for a side effect / adverse event only when the Principal Investigator (PI) has documented in the medical record that, in his/her opinion, there is a definite causal relationship with the study intervention. Routine care is considered conventional care, which will be provided whether or not the patient is enrolled in the study. Routine care can be billed to 3rd party payers, except to the extent the sponsor of the Study provides funding for these routine care services/procedures.Non-routine care is considered care only provided for research purposes (this care will not be provided if the patient is not enrolled in the study). A study sponsor typically pays for or provides the item or service. Non-routine care cannot be billed to 3rd party payers.Are all protocol activities considered routine care? __ Yes __ No If "No", all routine and non-routine care study activities must be documented.If a sponsor's Study Activity Grid is available, attach it to this page. This grid mustdetail all care provided in the study, and each item of care must be noted as either routine or non-routine. If a sponsor’s Study Activity Grid is not available or if the study is a SJMH investigator-initiated research project, the SJMH “Study Activity Grid” (set forth below) must be completed.Study Activity GridRoutine Care Item or ServiceTime point of Occurrence (i.e. baseline, 1 month)Sponsor providing funding to cover cost of service/procedure?CommentsNon-Routine Care Item or ServiceTime point of Occurrence (i.e. baseline, 1 month)Sponsor providing funding to cover cost of service/procedure?CommentsNote: Activities that are listed as routine care may still have an associated payment listed on the study budget. This payment is not intended to cover the procedure, but is intended to cover the research component of the activity, which could include such activities as data management and processing. Section C: Study Team Approval: The assessment of routine care vs. non-routine care activities has been reviewed with the study team and approved by the Principal Investigator (PI). All necessary institutional mechanisms will be implemented by the study team to ensure that the non-routine care items are flagged for removal from the patient’s bill.Document Prepared By:_________________ Date: ______________________PI Signature: _________________________ Date: ______________________ ................
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