Clinical Trial Submissions – AFTER JANUARY 1, 2015
Coverage Requirements
The CMS Clinical Trial Policy (CTP) covers the routine costs of qualifying clinical trials, as such costs are defined below, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply. See the CMS Routine Costs in Clinical Trials (310.1) CMS Routine Costs in Clinical Trials (310.1) NCD
.
CED Requirements
Coverage with Evidence Development (CED) Medicare may issue an NCD that requires participation in certain clinical trials, longitudinal studies, or registries for coverage of an item/service and routine and related items/services.
- See all CED studies on the CMS Coverage with Evidence Development
- Notify CGS via email with the following information:
- Name of Study
- NCT Registry Number
- IDE Number
- Facility Name and Medicare Number
- Attach your CMS and IRB Approval letters with the email.
Investigational Device Exemption (IDE)
Trials approved by FDA after January 1, 2015, will require additional information for MACs may require facilitating claims payment.
In order to update the Medicare Payment System e-mail to J15IDE@cgsadmin.com the following:
- IRB approval letter with start/stop dates of approval
- IDE Number listed in the CMS approval letter
- Copy of CMS Approval Letter
- Facility Name and PTAN (Medicare Number)
- Participating Providers Name and NPI Number (make note of the PI for the study)
The above information may be provided in the body of an email or by using the CGS IDE Submission Form PDF
and emailing this information to J15IDE@cgsadmin.com
Extensions
Submit via email to J15IDE@cgsadmin.com
- IRB approval of the extension with start/stop dates of approval
- List of participating facilities (with PTAN/ & providers noting any changes
- Protocol summary of any changes
- Summary 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.
Send all information to J15IDE@cgsadmin.com
Protocol Changes Only
- Please email a summary of the changes and IRB approval 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
Resources
- CMS Coverage with Evidence Development
- MLN Matters MM8401 – Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims
- CMS Internet Only Manual (IOM), Publication 100-04, Medicare Claims Processing Manual, Chapter 4, Section 61.3.5
- Sec 60: Billing for Devices Eligible for Transitional Pass-Through Payments and Items Classified in "New Technology" APCs
- Sec 61: Billing for Devices under the OPPS
- Sec 61.3: Billing for devices Furnished Without Cost to an OPPS Hospital or Beneficiary or for Which the Hospital Receives a Full or Partial Credit and Payment for OPPS Services Required to Furnish the Device
- CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 32, Section 69.6
- Sec 67: No Cost Claims
- Sec 68: Investigational Device Exemption (IDE) Studies
- Sec 69: Qualifying Clinical Trials
- Sec 70 Billing Requirement for Islet Cell Transplantation for Beneficiaries in a National Institutes of Health (NIH) Clinical Trial
- CMS Mandatory Reporting of National Clinical Trial (NCT) Identifier Numbers on Medicare Claims – Q&A
- CMS Medicare Coverage Related to Investigational Device Exemption (IDE) Studies
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