April 4, 2008
Investigational Device Exemptions
Medicare may provide coverage and reimbursement for certain investigational devices and services related to the use of those devices. Such services may be covered when they are necessary to the use of the device, as part of the preparation for the use of the device or for the follow-up care after device use. Coverage is contingent upon meeting regulatory criteria (listed below) and upon the Medicare contractor’s approval of the application for reimbursement.
Background
Title XVIII of the Social Security Act prohibits Medicare from providing coverage for the use of devices that are not “reasonable and necessary for the diagnosis and treatment of an injury or illness or to improve the functioning of a malformed body member” [1862(a)(1)(A)]. Consequently, Medicare denied any and all reimbursement for experimental devices and associated costs due to the absence of medical necessity that could not be established when the safety and effectiveness of a device was unknown. A device the Food and Drug Administration (FDA) categorized as investigational was presumed to be experimental, including devices being studied under investigational device exemptions (IDEs). A medical device required FDA-approval for marketing (post-marketing approval or “PMA”), the device’s safety and effectiveness having been established, to qualify for payment consideration.
On November 1, 1995, Congress enacted legislation that now permits coverage of some investigational devices. That legislation directed Medicare to cover the use of certain devices classified by the FDA as category B investigational devices, under the auspices of an IDE. In 2003, Congress passed the Medicare Modernization Act which directed Medicare to provide limited coverage for the use of certain category A devices. Coverage for both categories of devices is contingent upon meeting certain criteria.
Category A consists of novel, first-of-a-kind technologies. These are innovative devices for which initial questions of safety and effectiveness have not been resolved, and the absolute risk of the device type has not been established. The FDA has insufficient evidence to determine whether these device types can be safe and effective.
Category B devices are a newer generation devices of already proven technologies where the initial questions of safety and effectiveness of these devices have been resolved.
Investigational Device Exemption coverage criteria
1. The device must be used in the context of an FDA and IRB (Institutional Review Board) approved study. Coverage is limited to a predetermined number of patients and a predetermined number of sites as specified in the FDA-approval letter and/or the study protocol.
2. The device must be used according to the clinical trial’s approved patient protocols.
3. The device must have an assigned IDE number. This identification number allows the Medicare contractor to establish the special claims processing procedures associated with the study.
4. The device must meet all Medicare’s coverage requirements.
• It must fall within a benefit category.
• In the event that the device itself and/or the associated services fall within the scope of a national or local coverage determination (NCD/LCD), it must meet the criteria set forth in the NCD/LCD.
• In the absence of an NCD/LCD, it must be considered reasonable and necessary in accordance with section 1862(a)(1)(a) of the Act.
5. Use of the device and the provision of associated services must be furnished in a setting appropriate to the patient’s medical needs and condition.
6. Category A devices are covered only to the extent that they are used in the diagnosis, treatment, or monitoring of a life-threatening disease or condition. Only the related routine care costs are covered. The device itself is not subject to reimbursement. Category B devices are covered in addition to the routine care costs.
Notes
1. Current statutes and regulations are not a guarantee of coverage for a device and associated services. Assignment of an IDE number, in and of itself, is also not a guarantee of coverage.
2. It is the responsibility of the provider participating in the IDE protocol to furnish any and all information about the device, the associated services, the protocol, and participating Medicare beneficiaries that the contractor deems necessary to make a coverage determination and to properly process claims.
3. Providers should not bill Medicare for services, supplies, or other costs, which are paid for, or provided by, another party.
4. Providers should not bill Medicare for services or costs associated with data collection, data analysis, coordinator time, or any cost not considered by the contractor as a routine clinical care cost.
5. Medicare contractors have discretion for the approval of coverage of devices and associated services under an IDE.
6. Approval by the contractor for an IDE should not be construed as prior authorization for specific services for specific Medicare beneficiaries.
7. If a hospital is the place of service, the FI may have other requirements for approval. (See billing information for Part A listed below).
Billing guidelines
Medicare Part A
The UB-04 (CMS-1450) claim form contains form locators (FLs) that must be specifically coded for IDE trial claims according to the Centers for Medicare & Medicaid Services (CMS) instructions, including:
Device Line FL 42: Revenue Code. Bill all IDE devices and procedures under revenue code 624. This code was specifically created by CMS to identify IDE devices and is only applicable to investigational devices and procedures with FDA and IRB-approved IDE.
FL 43: IDE Number, “G prefix field.” For claims submitted via paper, enter the 7-digit IDE number for the trial in form locator 43. For electronic claims, enter the IDE number on the bottom of page 4. Look for “ID” and a two-digit field (for entering the line number that corresponds to revenue code 624) and then the seven-digit field for the IDE number. If using DDE and entering a new claim, the IDE field is on page 3, identified as “IDE.”
FL 44: If exists, HCPCS or “C” code. In FL 44, opposite the 624 revenue code, list the appropriate HCPCS or “C” code for the device/procedure, may be xxx99. The ICD-9-CM diagnosis codes listed on the claim must be consistent with IDE trial indications.
Procedure Line FL 42: Rev CD for site of service FL 43: Description FL 44: HCPCS/CPT; use closest appropriate HCPCS section or group; may be xxx99.
Medicare Part B
The CMS-1500 (08-05) claim form (or the electronic equivalent) must be specifically coded for IDE claims in accordance with CMS instructions, as follows:
ICD-9-CM Diagnosis Codes: The ICD-9-CM diagnosis codes listed on the claim must be consistent with the IDE trial indications. Category A IDE coverage requires an immediately life-threatening disease or condition. The ICD-9-CM code must reflect this. Additionally, V70.7, “examination of a participant in clinical trial,” must be reported as a secondary diagnosis.
IDE Number: The IDE number is reported in item 23 (or the electronic equivalent) when an investigational device is used in an FDA-approved clinical trial. Claims for services associated with a Category A or Category B IDE must report the appropriate modifier based on date of service as indicated in the tables below. These modifiers are reported in item 24D (or the electronic equivalent).
Medicare coverage and billing requirements
Dates of service 01/01/2008 and after
Coverage and Billing Requirements |
Clinical Trial (Non IDE) |
Category A IDE |
Category B IDE |
|---|---|---|---|
Device or Drug Payable? |
NO |
NO |
YES |
Associated Routine Costs Payable? |
YES |
YES |
YES |
Life Threatening Dx Required? |
NO |
YES |
NO |
IDE # in Item 23 Required on CMS-1500? |
NO |
YES |
YES |
IDE # in FL 43 Required on CMS-1450? |
NO |
YES |
YES |
Primary Dx V70.7 Required? |
CMS-1500 only |
NO |
NO |
Secondary Dx V70.7 Required? |
CMS-1450 only |
YES |
YES |
Modifier Q0 per Line Required? |
NO |
YES |
YES |
Modifier Q1 per Line Required? |
YES |
NO |
NO |
Revenue Code 624? |
NO |
YES |
YES |
Medicare coverage and billing requirements
Dates of service prior to 01/01/2008
Coverage and Billing Requirements |
Clinical Trial |
Category A IDE |
Category B IDE |
|---|---|---|---|
Device or Drug Payable? |
NO |
NO |
YES |
Associated Routine Costs Payable? |
YES |
YES |
YES |
Life Threatening Dx Required? |
NO |
YES |
NO |
IDE # in Item 23 Required on CMS-1500? |
NO |
YES |
YES |
IDE # in FL 43 Required on CMS-1450? |
NO |
YES |
YES |
Primary Dx V70.7 Required? |
CMS-1500 only |
NO |
NO |
Secondary Dx V70.7 Required? |
CMS-1450 only |
YES |
YES |
Modifier QV per Line Required? |
YES |
YES |
NO |
Modifier QA per Line Required? |
NO |
NO |
YES |
Revenue Code 624? |
NO |
YES |
YES |
Useful links
Medicare Benefit Policy Manual (Pub. 100-02, Ch. 14), Medical Devices
FDA Clinical Trial and Investigational Device Exemption Web page
Investigational Device Exemption (IDE) approval requirements
• The name and description of device
• A copy of the study protocol, summaries and abbreviated versions are not acceptable
• Identification of the sponsor of the trial
• Identification of the funding agency/organization, if different from sponsor
• A copy of the Food and Drug Administration-approval letter (Redacted letters are not sufficient. Conditional approvals only if safety issues addressed).
• Identification of lead investigator
• Identification of assigned IDE #
• A copy of local/hospital/institutional IRB-approval
• Stipulation as to the anticipated place of service (initial device implantation/attachment)
• An outline of a typical claim identifying codes to be billed on the initial date of service (implantation/attachment of device) to include:
• Physician services (CPT/HCPCS) codes submitted to the carrier
• Facility services [(CPT/HCPCS) (APC; ICD-9: DRG)] submitted to the fiscal intermediary
• If unlisted code is used, a complete description of the procedure and estimate of appropriate RVUs based upon similar CPT/HCPCS codes
• A copy of the informed consent document and/or protocol for obtaining informed consent
• Pertinent articles in the form of at least two publications in the peer reviewed literature
• A copy of all agreements between the sponsor and the provider, especially, but not limited to, financial agreement
• Notification of any and all costs by code to be billed in association with the study. Identification of all services as either routine care costs or data acquisition/study related costs, by code, including the anticipated frequency of billing. Note: Data acquisition/study related costs are not billable to Medicare.
• A signed IDE Coding and Cost Information form must be included with your request. (See link below).
I certify the above is accurate and complete and understand that it is my responsibility to ensure that claims are submitted to Medicare in compliance with Medicare guidelines.
_______________________________________________________________________________
(To be signed by IDE investigator or proxy)
Please submit this document with the above requested materials to:
First Coast Service Options, Inc.
Attn: Medical Policy and Procedures
532 Riverside Avenue, 19T
Jacksonville, FL 32202-4914
Attn: Medical Policy and Procedures
532 Riverside Avenue, 19T
Jacksonville, FL 32202-4914
First Coast Service Options will make a coverage determination within 45 days of submission of all the required documentation.
