Clinical Trial Submissions – Extensions, Protocol/Roster Changes
EXTENSIONS
Submit via email to J15IDE@cgsadmin.com
- IRB approval of the extension with start/stop dates of approval
- Any facility/provider changes
- Protocol summary of any changes
- Adverse Events that may have occurred during the previous approval period
The above information may be provided via email or by using the CGS IDE Submission Form PDF
or simply emailing the information to J15IDE@cgsadmin.com
PROTOCOL CHANGES only
- please email a summary to CGS at J15IDE@cgsadmin.com
ROSTER CHANGES only
- These no longer require CGS approval
- CMS Approved IDE Studies
BILLING REQUIREMENTS:
The associated IDE/NCT numbers MUST be included on each claim. These numbers are listed at the beginning of this approval letter. The below applies to both Institutional and Professional claims:
- The 7-digit alpha numeric IDE number should be placed in REF02 (REF01=LX)
- Professional Claims: 8 Digit NCT Registry Number must be placed in Loop 2300 REF02 (REF01=P4)
- ICD-10 code Z00.6 (in either the primary or secondary positions)
- Modifier Q0 and/or Q1, as appropriate (outpatient claims only).
All institutional claims submitted electronically must include:
- Condition Code 30;
- ICD-10 diagnosis code Z00.6 either in the primary or secondary position of the diagnosis set of the claim; and
- Value Code D4 along with the 8-digit clinical trial as the value
- Along with the above, there are additional requirements for outpatient and inpatient claims.
- For outpatient claims, the modifier Q0 and/or Q1 must be appended to the corresponding HCPCS and/or CPT code(s).
- For inpatient claims, revenue code 0624 (FDA Investigational Device) must be present, along with the IDE number in the line-level detail information in Loop 2300.
Clinical Trials, Prospective Studies, and Registries Coverage
- Mandatory Reporting of National Clinical Trial (NCT) Identifier Numbers on Medicare Claims – Qs & As
Coverage Elements CTP IDE CED CMS approval required No. Must qualify under NCD 310.1 Yes. Each specific study approved by FDA before 1/1/2015, requires MAC approval; studies approved by FDA after 1/1/2015 require CMS approval Yes. Requires CMS approval for each specific study Public notification No. Provider determines qualification Each study approved by FDA after 1/1/2015 appears on CMS IDE Website Each study approved by CMS appears on CMS CED Website Routine services (Q1) Covered if otherwise coverable by Medicare in qualified study Covered in a CMS approved study, if otherwise considered a covered service outside a study. Covered in a CMS approved study, if otherwise considered a covered service outside a study. Investigational item/ service (Q0) EXEMPT Covered if item/service is Category B, and approved by CMS Covered if study is approved by CMS - CMS Approved IDE Studies
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