Centers for Medicare & Medicaid Services Approved Clinical Trials

Posted November 02, 2012

The Centers for Medicare & Medicaid Services (CMS), in the development of National Coverage Determinations (NCDs), created a category of "Coverage with Evidence Development." Coverage with Evidence Development (CED) provides limited Medicare coverage for beneficiaries enrolled in CMS-approved clinical trials and requires the collection of additional patient data to supplement standard claims data.

Currently CMS has published three (3) NCDs under DME MAC jurisdiction that provide for coverage under CED:

1. Transcutaneous Electrical Nerve Stimulation (NCD Manual, Chapter 1, Section 160.27);

2. Home Use of Oxygen in Approved Clinical Trials (NCD Manual, Chapter 4, Section 240.2.1)

3. Home Oxygen Use to Treat Cluster Headaches (NCD Manual, Chapter 4, Section 240.2.2)

Information regarding which clinical trials are approved by CMS under CED may be found on the CMS Web site at: Suppliers should utilize this resource in order to verify the participation of the beneficiary in a CMS-approved clinical trial and to determine the proper ClinicalTrials.Gov study identifier. As of October 5, 2012, no clinical studies involving TENS for treatment of chronic low back pain (CLBP) or home use of oxygen for cluster headaches have been approved by CMS. There is one CMS-approved study for the home use of oxygen in approved clinical trials - Long-Term Oxygen Treatment Trial (ClinicalTrials.Gov Identifier NCT00692198).

Coverage of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) items for beneficiaries enrolled in CMS-approved clinical trials must meet specific documentation requirements, including providing the specific ClinicalTrials.Gov identifier. Suppliers are strongly encouraged to review the Local Coverage Determinations (LCDs) and policy articles (PAs) located on the NHIC, Corp. DME MAC A Web Site to review the guidelines for billing and coverage when the DMEPOS item is being used for a beneficiary due to inclusion in a clinical trial. If LCDs and PAs are not available for the DMEPOS item being billed, a National Coverage Determination may be available. Suppliers can access NCDs in the Internet-Only Manual Publication 100-03, Medicare National Coverage Determinations Manual on the CMS web site at


Last Updated Dec 19 , 2019