When requesting recognition as participants in investigational device exemptions (IDEs), you must adhere to the instructions contained in the CMS Manual System, Pub 100-04, Medicare Claims Processing Manual, Chapter 32 (Billing Requirements for Special Services), Section 68 (Investigational Device Exemption (IDE).
The following information must be furnished to Palmetto GBA prior to submission of a claim for payment:
- Your Medicare provider number or NPI
- 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:
| Regular Mail|| Overnight Mail
| Palmetto GBA
|| Palmetto GBA
| Attn: Medical Affairs, AG-275
|| Attn: Medical Affairs, AG-275
| P.O. Box 100238
|| 2300 Springdale Dr. Bldg. 1
| Columbia, SC 29202-3238
|| Camden, SC 29020-1728
Part A Medical Affair Fax number: (803) 462-2652
Part B Medical Affair Fax number: (803) 382-2424
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 mail this packet to one of the addresses above.
If approved, facilities will receive an authorization letter from Palmetto GBA. Providers should adhere to the billing requirements described in CMS Manual System, Pub 100-04, Medicare Claims Processing Manual, Chapter 32, Section 68 of the Medicare Claims Processing Manual to ensure the proper processing of IDE claims.
The term 'Clinical Trials' is not synonymous with 'IDE'. Available Medicare coverage for each is based on different standards. Refer to the CMS website for 'Clinical Trials,' CMS Manual System, Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 310.1 and for 'Investigational Device Exemptions (IDEs),' CMS Manual System, Publication 100-02, Medicare Benefit Policy Manual, Chapter 14, Sections 20-110.
Providers should adhere to the billing requirements described in the CMS Manual System, Publication 100-04, Medicare Claims Processing Manual, Chapter 32, Section 69 of the Medicare Claims Processing Manual to ensure proper processing of claims for qualifying clinical trial services.
For additional billing requirements related to 'no cost items' please see CMS Manual System, Publication 100-04, Medicare Claims Processing Manual, Chapter 32, Section 67.