Coverage of Investigational Device Exemptions (IDEs) Category B Devices
As of November 1, 1995, Medicare began coverage of certain FDA-approved and Institutional Review Board (IRB)-approved investigational devices and services incident to, provided the investigational device meets the following conditions:

An IDE may be covered if all of the following criteria are met:

• It appears on the listing of devices eligible for coverage/payment on CMS’s master file of IDE devices;
• It is reasonable and necessary for the individual patient;
• The device or services associated with the use of a device were provided to the beneficiary within the start and end dates contained in the master file; and
• There is no national coverage policy that would otherwise prohibit Medicare coverage.

Devices that may be covered under Medicare include the following categories:

• Devices approved by the FDA through the Pre-Market Approval (PMA) process;
• Devices cleared by the FDA through the 510(k) process;
• FDA-approved IDE Category B devices; and
• Hospital Institutional Review Board (IRB)-approved IDE devices.

It is the responsibility of the provider participating in the clinical trial to furnish all necessary information concerning the device, the clinical trial and participating Medicare beneficiaries that the contractor deems necessary for a coverage determination and claims processing. (Pub 100-2, Chapter 14, section 40)

The following items are required:

1. Cover letter

• Cover letters from the provider(s) (physicians and facilities) on official letterheads requesting the coverage for Part A (for Connecticut, Delaware, and New York, and in Massachusetts for SNFs only), and Part B [for downstate New York (excluding Queens) and New Jersey].
• The letters must identify the name of the study, the IDE#, a list of participating providers (physicians and facilities) with provider names and numbers, who will be involved with the IDEs.
• The letters must include the number of subjects (Medicare and Non-Medicare) that will participate in the trial.
• The letters must include the effective date for each facility’s participation in the study.
• The letters must be cosigned by the clinical investigator or research coordinator and an official representing the institution (hospital).

2. FDA Approval
   A copy of the FDA approval letter provided to the sponsor or manufacturer of the device. The approved IDE number must be on the letter.

Clinical protocol

• A full copy of the clinical protocol.
• Copies of supporting articles published in peer reviewed literature.

3. Scheduled services
   • Suggested ICD-9-CM codes.
   • Listing of all services that will be billed to Medicare (CPT, HCPCS and ICD-9-CM codes) with expected frequency.
   • Place of service (e.g., inpatient, outpatient).
4. Informed consent

A copy of the IRB-approved informed consent presented to participating beneficiaries.

5. Investigation agreement:
   • A copy of the sponsor’s investigation agreement, including payments by the sponsor to the investigators and hospital.
   • A statement from the sponsor as to whether the device is sold, discounted, or donated to the institution.
   • A statement from the sponsor disclosing any administrative fees given to the institution.
   • A statement from the sponsor disclosing any fees given to the participating provider, itemizing the specific reason for each fee.
     
6. Institutional Review Board (IRB) information
   • Copy of IRB study approval letter.
   • Expiration date of the IRB approval and start-of-approval date.
     
7. Manufacturing information :
   • Name of device, both trade and common or usual classification name.

Coding Information:
Claims for the Category B Devices should be submitted as follows:

For Medicare Part A:

• Hospitals must place the IDE # of the Category B device in Form Locator 43 (along with a description of the investigational device) on the CMS-1450 paper form, or the electronic equivalent.
• For part A, the revenue code 624 (IDE) must be entered in Form Locator 42, or the electronic equivalent.

For Medicare Part B:

• Physicians must place the IDE# of the Category B device in Item 23 of the CMS-1500 claim form, or the electronic equivalent.
• Appropriate ICD-9-CM codes and CPT/HCPCS codes that relate to the IDE must be reported on the claim.
• The Modifier QA must be appended to the CPT/HCPCS codes.

Ref: Pub. 100-2, Medicare Benefit Policy Manual, Chapter 14, section 10-110

Coverage of Routine Costs of Clinical Trials Involving Investigational Device Exemptions (IDEs) Category A Devices
Section 731 (b) of the MMA authorizes Medicare to cover the routine costs of clinical trials involving IDE Category A devices effective for routine costs incurred on or after January 1, 2005. Category A (experimental/investigational) devices are innovative medical devices believed to be in Class III, for which “absolute risk” of the device has not been established (that is, initial questions of safety and effectiveness have not been resolved and the Food and Drug Administration (FDA) is unsure whether the device can be safe and effective).

In addition, the MMA established additional criteria for trials initiated before January 1, 2010, to ensure that the devices involved in these trials be intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition.

Note: The Category A device itself remains noncovered.

Requested Items:
All of the items listed above for Category B devices must be submitted to Empire Medicare Services.

The following additional information must also be submitted:

• A summary of the participating beneficiaries’ medical history and the nature of the disease or condition that would necessitate participation in the clinical trial for the Category A device for diagnosis, monitoring, or treatment.
• The trial’s lead principal investigator certification that the trial meets the criteria. This process will require the principal investigator to enroll the trial in a Medicare clinical trials registry, currently under development.

Coding Information:
Claims for the routine services performed in a clinical trial where a category A device is used for a patient with a life-threatening condition should be submitted as follows:

For Medicare Part A:

• Hospitals must place the IDE # of the Category A Device in Form Locator 43 of the CMS-1450 paper form, or the electronic equivalent.
• For outpatient claims, Revenue code 0624, Condition code 30, ICD-9-CM code V70.7.
• The Modifier QV must be appended to the CPT/HCPCS codes, for outpatient claims.
• For inpatient claims, Condition code 30 and ICD-9-CM code V70.7 must be reported.

For Medicare Part B:

• Physicians must place the IDE# of the Category A device in Item 23 of the CMS-1500 claims form, or the electronic equivalent.
• The appropriate CPT/HCPCS codes and ICD-9-CM code V70.7 must be reported.
• The Modifier QV must be appended to the CPT/HCPCS codes.

Ref: Pub.100-20, Transmittal #131, CR #3548
Pub. 100-3, Medicare National Coverage Determination, Chapter 1, Part 4, section 310.1

Routine Costs in Clinical Trials
(Category A and Category B Devices)
Covered routine costs in clinical trials must meet all of the following criteria:

• Items or services are typically provided absent a clinical trial (e.g., conventional care);
• Items or services are required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent);
• The clinically appropriate monitoring of the effects of the item or service, or the prevention of complications;
• Items or services are needed for reasonable and necessary care arising from the provision of an investigational item or service - in particular, for the diagnosis or treatment of complications;
• The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category (e.g., physicians’ service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids);
• The trial must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent;
• Trials must enroll patients with diagnosed disease rather than healthy volunteers;
• The trial does not unjustifiably duplicate existing studies;
• The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully;
• The trial is in compliance with federal regulations relating to the protection of human subjects; and
• All aspects of the trial are conducted according to the appropriate standards of scientific integrity.

Noncovered costs include:

• The investigational Category A Device itself;
• Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan); and
• Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial.

Submission of Information and Documents to Empire Medicare Services
Request for approval of reimbursement must be submitted to both the Medicare Carrier (Part B) and the Fiscal Intermediary (Part A) for the jurisdiction in which these services will be billed. If Empire is both the Carrier and the Fiscal Intermediary (i.e., Downstate NY), then both applications should be submitted together.

A table of contents using the enumerated items with highlighted divider markers for each section would be helpful.

Please note that Empire Medicare Services is the Fiscal Intermediary for Connecticut, Delaware, and New York, and in Massachusetts for certain SNFs only. Empire Medicare Services is not the Fiscal Intermediary for New Jersey. We will accept the Part A application for states within our jurisdiction. The Part B applications should be sent to the appropriate Carrier.

The package of information and documents should be submitted to Empire Medicare Services for Part A (for Connecticut, Delaware, and New York, and in Massachusetts for certain SNFs only), and Part B [for Downstate New York (excluding Queens) and New Jersey] at the following address:

Ms. Antonia Andreotti
Empire Medicare Services
2651 Strang Boulevard
Yorktown Heights , NY 10598

Click here to View: INVESTIGATIONAL DEVICE EXEMPTIONS (IDEs) CATEGORY A AND B DEVICES - Checklist of All Items Required

Posted: 07/20/2006

CPT codes, descriptions, and other data only are copyright 2005 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Apply.