NOTICE CONCERNING USE OF AND BILLING FOR INVESTIGATIONAL DEVICES
TO:
FROM:Institutional Review Board
PDC Compliance Office
DUHS Compliance Office
DUHS Patient Revenue Management Organization (PRMO)
DATE:
RE: IRB Registry eIRB #______
If this is an eIRB conversion from a previous study, please include the previous IRB Registry # ______(if applicable)
Title of study:
Please list device Class (I, II, or III)______
If a Class III Device, please list Category (A or B) ______
(See attachment for explanation of device classes and categories)
FDA Assigned IDE Number (if assigned) ______
CC:PRMO CLINICAL TRIALS BILLING ()
Because your clinicaltrial involves the use of a medical device that is not FDA approved for its intended use, you must be aware of applicable reimbursement and compliance regulations that govern payment of trial-related costs by a subject’s insurance carrier. These regulations are separate from any DUHS IRB requirements you must satisfy for approval of your clinical trial. Your completion of the form and its submission to ______are necessary to ensure DUHS’ compliance with federal regulations regarding the billing of costs associated with investigational devices which have been granted an IDE by the FDA.
In general, Medicare only covers items or services that are “reasonable and necessary” (See Section 1862(a)(1)(A) of the Social Security Act). The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (formerly known as HCFA) have worked together to develop clinical trial coverage guidelines and reimbursement requirements. All investigational devices for which an IDE is issued by the FDA are classified as either Class I, Class II, Class III (Category A) or Class III(Category B)devices, depending on the risk and/or research status of the device, as described in the attached “Explanation of Device Classes”. As Principal Investigator for your clinical trial, you are responsible for the accurate characterization of your device in your IDE submission to the FDA.
Please initial the statement below that describes the Class and Category, if applicable, granted by the FDA in your IDE reflects Required Actions, as listed below, when submitting all professional and / or technical charges that are related to your research. Please attach a copy of your INITIAL FDA letter showing the “CMS Reimbursement Category”.
CLASS I or II:
If you are conducting a clinical trial with a Class I or II Device, the procedure(s) and all related or incident to care may be reimbursed by Medicare and other payers, if standard coverage criteria are met.
______I(Principal Investigator) will follow the Required Actions outlined in this memorandum when submitting professional and / or technical bills for patient care directly related to the use of the device or any other care that is related or incident to the use of the Class I or II device.
Class III Category A:If you are conducting a clinical trial under a Class III “Category A” IDE (Investigation Device Exception), the procedure(s) and all related or incident to services CANNOT be billed to any payer.
______I (the Principal Investigator) will follow the Required Actions outlined in this memorandum. In addition, I will not submit professional and / or technical charges for any patient care directly related to the use of the device or any other care that is related or incident to the use of the Class III Category A device.
Class III Category B:
If you are conducting a clinical trial under a Class III “Category B” IDE, the procedure(s) and all related or incident to care may be reimbursed by Medicare and other payers, if standard coverage criteria are met.
______I (the Principal Investigator) will follow the Required Actions outlined in this memorandum when submitting professional and / or technical charges for patient care directly related to the use of the device or any other care that is related or incident to the use of the Class III Category B device.
Required Actions:
1)I, or my clinical research coordinator (“CRC”), will provide to the PRMO Billing Office any information it deems necessary to establish an internal procedure code that will be used to track the utilization of the device.
2)I, or my CRC, will ensure that the internal procedure code assigned to the device (see 1 above) is submitted when the device is used (i.e. actions must be taken to ensure that the specially assigned investigational device procedure code is submitted through the regular charge capture systems).
3)I, or my CRC, will place a copy of the “IDE Notification Form” (copied enclosed with this memorandum) in the patient’s inpatient medical record.
4)I, or my CRC, will provide the PRMO Billing Office (Fabian Stone at DUMC 3810 or Fax at 668-5155) with a quarterly list of any patient that had any direct or indirect care that involved the use of a Class III Category A device. The report is due to the PRMO Billing Office twenty-one days after the end of the respective quarter (i.e., if a Class III Category A trial was active during the previous quarter, the report is due on either April 21st, July 21st, October 21st, or January 21st, as applicable )
5)I, and my CRC, understand the PDC’s Action Code system (i.e., the RG [Research Grant] and MN [Medically Necessary] Action Codes) and will use and assign the Action Codes as defined in the PDC’s Research Billing Policy. If I, or my CRC, have any questions about their use, I will contact the PDC Compliance Office (Mark Cantrell at 668-5161).
______
Signature of Principal InvestigatorDATE
Explanation of Device Classes
Class I:
•Class I refers to devices for which the general controls of the Food, Drug, and Cosmetic Act, such as adherence to good manufacturing practice regulations, are sufficient to provide a reasonable assurance of safety and effectiveness
–Example: Cane
•By statute and FDA regulation almost all Class I devices (with the exception of Reserved Devices) are exempt from the premarket notification requirement (510K), and no premarket approval can be required.
–Example of a Reserved Device: Breath-alcohol test system.
•Class I devices are not critical / high risk devices (i.e., they do not present a potential unreasonable risk of illness or injury
Class II:
•Class II refers to devices that, in addition to general controls, require special controls, such as performance standards or postmarket surveillance, to provide a reasonable assurance of safety and effectiveness.
•The FDA is required by statute to publish a list of generic types of Class II that are exempt from the premarket notification [510(k)] requirements, and no premarket approval can be required.
Example: Hematocrit measuring device
Class III:
•Class III refers to devices that cannot be classified into Class I or Class II because insufficient information exists to determine that either special or general controls would provide reasonable assurance of safety and effectiveness.
•Class III is the most stringent regulatory category for devices.
•Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
Category A and B:
Category A: Experimental/investigational device refers to:
•An innovative device believed to be in Class III for which "absolute risk" of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved and the FDA is unsure whether the device type can be safe and effective).
Category B : Non-experimental/investigational device refers to:
•A device believed to be in Class I or Class II; or
•A device believed to be in Class III for which the incremental risk is the primary risk in question (that is, underlying questions of safety and effectiveness of that device type have been resolved); or
•A device type that can be safe and effective because, for example, other manufacturers have obtained FDA approval for that device type.
For CMS submission
Indicate the expected CPT and HCPCS codes that will be utilized:
ndicate the expected CPT and HCPCS codes that will be utilized:
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List all physicians that will be billing for this and their Medicare Provider ID numbers:
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