Medicare Cost Analysis – Documentation of Research Billing Review Form

Study 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"

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Coverage Analysis Guidelines

In 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 Checklist

  1. Is the subject or purpose of this trial an evaluation of an item or service that falls within a Medicare benefit category? __ Yes __ No
  1. Does the trial have therapeutic intent? __ Yes __ No
  1. Does the trial enroll patients with a diagnosed disease? __ Yes __ No
  1. Do any of the following apply to this study? ___ Yes ___ No

If Yes, circle one of the following.

  1. Trials funded by NIH, CDC, AHRQ, HCFA, OD and VA
  2. Trials supported by centers or cooperative groups that are funded by the federal agencieslisted above in (a)
  3. Trials conducted under an IND reviewed by the FDA
  4. Drug trials exempt from having an IND under 21 CFR 312.2(b)(1)
  5. 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.

  1. Does this study satisfy the following characteristics?
  1. The principal purpose of the trial is to test whether the intervention potentially improves participants’ health outcomes. __ Yes __ No
  1. The 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 __ No
  1. The trial does not unjustifiably duplicate existing studies. __ Yes __No
  1. The trial design is appropriate to answer the research question being asked in the trial. __ Yes __ No
  1. The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully. __Yes __ No
  1. The trial is in compliance with Federal regulations relating to the protection of human subjects. __Yes __ No
  1. All aspects of the trial are conducted accordingly to the appropriate standards of scientific integrity. __Yes __ No

If 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 Worksheet

The CMS National Coverage Decision for Routine Costs in Clinical Trials allows for coverage of routine costs during a qualifying clinical trial andclaims 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 isconsidered care only provided for research purposes (this care will not be provided if the patient is not enrolled in the study). A study sponsortypically 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 andnon-routine care study activities must be documented.

If a sponsor's Study Activity Grid is available, attach it to this page. This grid must

detail 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 Grid

Routine Care Item or Service / Time point of Occurrence (i.e. baseline, 1 month) / Sponsor providing funding to cover cost of service/procedure? / Comments
Non-Routine Care Item or Service / Time point of Occurrence (i.e. baseline, 1 month) / Sponsor providing funding to cover cost of service/procedure? / Comments

Note: 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 teamand 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: ______

Version: dated 032015

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