Instructions for Both Part A and Part B Providers

July 03, 2006 (Original Date of Notice)

Revision Date: December 13, 2006

This bulletin should be shared with all health care practitioners and managerial members of the provider/supplier staff. Additional copies may be downloaded from our website at:

www.highmarkmedicareservices.com

Background

On November 1, 1995, Medicare coverage was expanded to certain medical devices that are being studied as part of a Food and Drug Administration (FDA) approved clinical trial, but have not been approved for marketing. Under this policy, the Centers for Medicare and Medicaid Services (CMS) and the FDA have established a more precise mechanism for classifying devices undergoing clinical trials that make it possible for certain devices to be eligible for Medicare coverage.

IDE Categories & Coverage

The new policy allows for a distinction to be made among devices subject to pre-market approval, to separate devices that can be considered for Medicare payment, and those that remain experimental. Two categories have been developed to classify devices under IDEs. These are:

Category A - Experimental

These consist of novel, first-of-a-kind technologies.
These are innovative FDA Class III devices for which the absolute risk of the device type has not been established and initial questions of safety and effectiveness have not been resolved.
The FDA is unsure whether these device types can be safe and effective.
Medicare covers the routine costs of clinical trials involving IDE Category A devices effective for routine costs incurred on or after January 1, 2005.
This extension of coverage only refers to the routine services performed for such a trial. The Category A device itself remains non-covered.

Category A Devices - Section 731 (b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) established 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. A life-threatening disease or condition is defined as: “a state of a disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.”

Category B – Non-Experimental/Investigational

These devices may be in FDA Class I, II, or III.

Devices placed in this category are considered to represent evolutionary changes in proven technologies.
Initial questions of safety and effectiveness of these device types have been resolved, and the incremental risk of this device, generally an update to an existing device, is the primary risk in question.
Medicare covers Category B devices if they are considered reasonable and necessary, AND if all other applicable Medicare coverage requirements are met.
This policy does not infer that all devices classified in Category B will be covered under Medicare.

Investigational Devices – the following are the procedures for Medicare contractors in making coverage decisions:

In their review, Medicare contractors are bound by the statute, regulations, and all CMS administrative issuances, including all national coverage decisions, just as for FDA-approved devices.
Medicare contractors must also consider additional information about the device’s use within the context of the FDA-approved clinical trial, and the trial’s approved patient protocols. Further, Medicare contractors must consider whether the device use is medically necessary for the particular patient; whether the amount, duration, and frequency of use or application of the service are medically appropriate; and whether the device is furnished in a setting appropriate to the patient’s medical needs and condition.
Statutorily excluded devices or items and services excluded from Medicare coverage through regulation or other CMS instructions are not eligible for coverage consideration.

Review of Application

Both Part A and Part B providers MUST furnish Highmark Medicare Services with the following information prior to submission of a claim for payment:

A copy of the FDA approval letter provided to the sponsor or manufacturer of the device,
The name of the device (both trade, common or usual, and classification name),
Action taken to conform to any applicable FDA special controls,
A narrative description of the device sufficient to make a payment determination,
A statement indicating how the device is similar to and/or different from other comparable products, and
The provider’s protocol for obtaining informed consent from patients participating in the clinical trial (the Informed Consent document approved by the Institutional Review Board (IRB)).

For Category A devices, submit in addition the information necessary to review the clinical trial, and to determine whether the device is being used for the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition (e.g., the study protocol, etc.).

This information should be sent to:

Office of the Contractor Medical Director
Highmark Medicare Services
1800 Center Street, 1A306
Camp Hill, PA 17089-0089
Attention: IDE Applications

Please allow 45 calendar days from date of receipt for review and processing of the IDE application.

Billing & Coding Guidelines

Each FDA-approved investigational device is assigned an identification code by the FDA, which enables Medicare contractors to establish special claims processing procedures associated with each study.

Claims will be accepted for approved Category B devices with a receive date on or after October 1, 1996 and a service date on or after November 1, 1995; claims will be accepted for routine costs involving Category A devices effective on and after January 1, 2005.

General Claims Submission

Providers may bill for either an IDE or a clinical trial but not both.

The IDE code will be seven positions in length, and may or may not include an alphabetic value in the first position.

Medicare Part A

Category A Devices Billing

The revenue code is 0624.
ICD-9 code V70.7 should be listed as a secondary diagnosis code.
Condition code is 30.
The IDE number should be placed on the 837i electronic claims format in 2300 Investigational Device Exemption Number REF Segment, data element REF02 (REF01=LX).
The QV modifier should be on the claim to reflect routine costs in a clinical trial associated with an IDE Category A device. CMS is working to obtain another modifier that will be required in addition to the QV modifier. Further information on that modifier is forthcoming from CMS.
Medicare will continue to deny (RTP) claims submitted for the IDE Category A device itself.
Providers may bill other charges on the IDE claim.

Category B Devices Billing

The revenue code is 0624.
The IDE must have a related HCPCS code for pricing purposes. The related IDE number and HCPCS submitted on a claim will be edited against a Master File. The Master File is furnished by CMS.
The IDE and the ICD-9-CM diagnosis codes should relate.
The IDE number should be placed on the 837i electronic claims format in 2300 Investigational Device Exemption Number REF Segment, data element REF02 (REF01=LX).
Payment for an IDE provided to a hospital patient is no different than payment for a FDA approved device. Deductible and coinsurance apply.
Payment for a Category B IDE in an inpatient setting is included in the DRG payment.
Providers may bill other charges on the IDE claim.

Medicare Part B

Physician Requirements

IMPORTANT! Physicians may not bill Medicare for these services prior to receiving Medicare Part A approval.

Billing & Coding Guidelines

Claims will be accepted for approved Category B devices with a receive date on or after October 1, 1996, and a service date on or after November 1, 1995. Claims will be accepted for routine costs involving Category A devices effective on and after January 1, 2005.

Part B providers are to bill using the appropriate HCPCS code and identify claims for IDE and/or services incident to the use of such devices with modifier –QA. They are also required to report the IDE number assigned the device on the HCFA 1500 claim form in Block 23 or in the Narrative Field of the electronic claim.

Claim adjudication instructions for Medicare Part B state, “Investigation devices are only covered when they are used in a clinical trial approved by the FDA. When billing a service with the investigational modifier (QA), the provider is certifying FDA approval of a clinical trial for the device.”

General Claims Submission

Providers may bill for either an IDE or a clinical trial, but not both.
The IDE code will be seven positions in length, and may or may not include an alphabetic value in the first position.
List the CPT code(s) that appropriately describes the service(s) performed; when a NOC code is used, then a description of the services and the device must be entered on line 19.

Category A Devices Billing

ICD-9 code V70.7 should be listed as a secondary diagnosis code.
Physicians who bill electronically for Category A devices must place the IDE number on the 2300 Investigational Device Exemption Number REF segment, data element REF02 (REF01=LX) of the 837p.
Providers should place the QV modifier on the claim to reflect routine costs in a clinical trial associated with an IDE Category A device. CMS is working to obtain another modifier that will be required in addition to the QV modifier. Further information on that modifier is forthcoming from CMS.
Providers should also note that Medicare will continue to deny (RTP) claims submitted for the IDE Category A device itself.

Category B Devices Billing

The IDE must have a related HCPCS code for pricing purposes. The related IDE number and HCPCS submitted on a claim will be edited against a Master file. The Master file is furnished by CMS.
The IDE and the ICD-9-CM diagnosis codes should relate. Providers should check the appropriate National Coverage Determination (NCD) or Local Coverage Determination (LCD) to identify those codes.
Payment for an approved investigational device exemption will not be greater than payment for the comparable FDA approved device currently covered by Medicare. Deductible and coinsurance apply.
Payment for a Category B device (that is provided to a non-hospital patient) and related services is limited to what Medicare would have paid for a comparable approved device.

FDA Withdrawal of IDE Approval

Potential Medicare coverage of Category B IDE devices is predicated, in part, upon their status with the FDA. In the event a sponsor loses its Category B status, or violates relevant IDE requirements necessitating FDA’s withdrawal of IDE approval, all payment for the device will cease.

The provider must notify Highmark Medicare Services within 30 days, at the address provided below so that all coverage and payment ceases as of the date of the violation, and/or FDA action. Billing for an IDE means that the provider attests that the device was approved at the time the service(s) was rendered. The CMS master file will be updated to reflect withdrawals of FDA IDE approvals.

            Office of the Contractor Medical Director
            Highmark Medicare Services
            1800 Center Street, 1A306
            Camp Hill, PA 17089-0089
            Attention: IDE Applications

Appeals Process for IDE Categorization Decisions

The FDA issues an IDE number that corresponds to each device granted an Investigational Device Exemption. Through an interagency agreement, CMS and the FDA have developed a process to categorize all FDA-approved IDEs for Medicare coverage and payment purposes. This categorization process differentiates between novel, first-of-a-kind devices for which absolute risk of the device type has not been established (Category A), and those devices which are of a device type for which the underlying questions of safety and effectiveness have been resolved (Category B).

A sponsor (manufacturer) who does not agree with the FDA decision that categorizes its device as Category A may submit a written request asking the FDA to re-evaluate its categorization decision. The sponsor may send a written request to the FDA at any time asking for re-evaluation of its original categorization decision. Additional evidence and information should be submitted to support a re-categorization. The FDA will notify both CMS and the sponsor of its re-evaluation decision.

If the FDA does not reverse its original decision on the categorization of the device, the sponsor may seek a review by CMS Central Office. The sponsor must forward its request in writing, including all materials submitted with their re-evaluation request to the FDA. CMS’s evaluation of a sponsor’s request for re-categorization will only include the information submitted to the FDA. Information not submitted to the FDA for its consideration will not be reviewed by CMS.

Review requests must be addressed to:

            Centers for Medicare & Medicaid Services
            IDE Categorization Review Committee
            Office of Clinical Standards and Quality Coverage and Analysis Group
            7500 Security Boulevard
            Room S3-25-25
            Baltimore, MD 21244-1850

CMS will review this information to determine whether to change the categorization of the device. CMS will issue a written decision notifying the sponsor and the FDA of its decision. To the extent that CMS relies on confidential commercial or trade secret information in its review, the Agency will maintain confidentiality of the information in accordance with Federal law. No reviews of a categorization decision, other than those described above are available to a sponsor.

Assistance

If you have any questions regarding this bulletin, please contact Highmark Medicare Services at one of the following numbers:

            Medicare Part A Maryland                         1-866-488-0545
            Medicare Part A Pennsylvania                    1-800-560-6170
            Medicare Part B Pennsylvania                    1-866-488-0548

Medicare A+B

Electronic Mailing Lists