National Government Services, Inc. Medicare Monthly Review Part A and B
A Combined Part A and Part B Newsletter

MMR-2007- 12AB, December 2007

Investigational Device Exemption Requests (Revised) 

National Government Services is revising the consolidated processing of Investigational Device Exception (IDE) requests in order to reduce duplication of effort and speed the response to providers. The electronic submission of all documentation, by e-mail or fax, is preferred and will substantially shorten the time required to review the information supplied. This information may be submitted to:

NGS-IDE-Request@wellpoint.com

Or

NGS-IDE-Request per fax: (540) 853-3692

Or

National Government Services IDE Request

602 S. Jefferson St .
Roanoke , VA 24011

Compliance with the instructions contained in the Medicare Claims Processing Manual is a requirement for both National Government Services and our providers. IDE request determinations (approval or denial) will be retroactive to the date the complete request is received by National Government Services. Any questions related to the IDE process may be submitted by e-mail, fax, or mail to the addresses listed above.

Inquiries submitted to the NGS-IDE-Request unit should contain, in the subject line, the provider’s name, the code assigned by the FDA, and the name of the study or device.

The following form may be used when submitting the request to National Government Services.

Contact person for this request:

Name: ______________________________________________________

Address: ______________________________________________________

Phone number: ______________________________________________________

Email address: ______________________________________________________

Request on behalf of (may be both categories):

[ ] Facility (ies) (Medicare Part A)

______________________________________________________

______________________________________________________

[ ] Individual practitioner(s) (Medicare Part B)

______________________________________________________

______________________________________________________

______________________________________________________

IDE number: ______________________________________________________

Study Name: ______________________________________________________

Trade name (device): ______________________________________________________

Common name: ______________________________________________________

National Government Services is requesting that the providers submit the following site specific information prior to billing for services.

Facility (ies) where service will be provided:

Participating practitioner (s):

Number of enrollees anticipated at the facility: _________________________

Anticipated bill type: (inpatient, outpatient, or both) _____________________________

The following site specific documents are needed to process this request. They may be submitted in hard copy or electronic format.

• A signed and stamped copy of the IRB approval letter.
• A copy of the informed consent approved by the IRB.
• A copy of the investigative agreement.
• A list of any devices, supplies, drugs, or services for which the facility or physician will be reimbursed by the manufacturer.

The following documents specific to the study, trial, humanitarian device exemption, and/or registry are needed to process this request. They may be submitted by either the sponsor or the provider.

• A non-redacted copy of the FDA approval letter provided to the sponsor or manufacturer of the device. The approved IDE code number must be on the letter.
• A description of any action(s) taken to conform to any applicable IDE special controls.
• A full copy of the applicable protocol.
• A narrative description of the device sufficient to make a payment determination. (If this is part of the protocol, please identify the portion of the protocol.)
• A statement indicating how the device is similar to and/or different from other comparable products. (If this is part of the protocol, please identify the portion of the protocol.)
• At least two (2) supporting scientific articles (full texts) for the investigational device and its intended indication published in peer reviewed literature.