Clinical Trial Submissions – ON OR BEFORE JANUARY 1, 2015
Trials initially approved by FDA before January 1, 2015, the Medicare Administrative Contractors (MACs) review IDE studies to determine coverage.
COVERAGE CRITERIA:
- Clinical Trial Policy (CTP) Medicare 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
- 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 CED studies on the CMS Coverage with Evidence Development
E-MAIL THE FOLLOWING INFORMATION TO: J15IDE@cgsadmin.com
- Complete the CGS Submission Form
- IRB Approval letter containing the start/stop dates of the approval
- Protocol
- FDA Approval letter – dated prior to January 1, 2015
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 |
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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