Billing Instructions for Investigational Device Exemptions (IDEs)

Interested parties with Food and Drug Administration (FDA) approval letters dated January 1, 2015 or later for IDE Category A or Category B studies that are seeking Medicare coverage for Category A or B IDE studies must submit a request packet to CMS. Please follow instructions found on the Medicare Coverage Related to Investigational Device Exemption (IDE) Studies CMS web page. Palmetto GBA does not require notification for CMS approvals.

Interested parties with Food and Drug Administration (FDA) approval letters dated prior to January 1, 2015, should submit the following information to Palmetto GBA prior to submission of a claim for payment:

• Medicare provider number or PTAN
• A copy of the Food and Drug Administration (FDA)-approval letter provided to the sponsor or manufacturer of the device. The approved IDE code number must be on the letter.
• The name of the device (both trade, common, or usual, and classification name)
• Any action taken to conform to any applicable IDE 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
• Indication of whether the device will be billed on an inpatient or outpatient claim
• A brief summary of the study design or a copy of the actual trial protocol
• The provider’s protocol for obtaining informed consents for beneficiaries participating in the clinical trial

This information should be forwarded to one of the following:

Jurisdiction J (Alabama, Georgia and Tennessee)

• Part A Medical Affairs Fax number: (803) 870-0133 or email: A.Policy@PalmettoGBA.com
• Part B Medical Affairs Fax number: (803) 870-0137 or email: B.Policy@PalmettoGBA.com

If you need to request approval for both Part A and Part B you may do so within the same packet of information. Please indicate this request on your cover letter. You may submit this packet to one of the options above.

If approved, facilities will receive an authorization letter from Palmetto GBA. Providers should adhere to the billing requirements described in CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 14, Sections 20-110 (PDF, 55 KB) and CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 32, Section 68 (PDF, 1.54 MB) to ensure the proper processing of IDE claims.

NOTE: The term "Clinical Trials" is not synonymous with "IDE." Available Medicare coverage for each is based on different standards. Refer to CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations (NCDs) Manual, Chapter 1, Part 4, Section 310.1 (PDF, 1 MB) and CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 32, Section 69 (PDF, 1.54 MB) to ensure proper processing of claims for qualifying clinical trial services. 

For additional billing requirements related to "no cost items" please see CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 32, Section 67 (PDF, 1.54 MB).