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2020 Updates to CGS Clinical Trial Submissions

Coverage

Medicare may pay for items and services in clinical research studies under three policies:

  1. 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) NCDExternal Website
  2. 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.
  3. Investigational Device Exemption (IDE) Policy Medicare may cover certain items/services in Food and Drug Administration (FDA)-approved IDE trials.

    Trials initially approved by FDA before January 1, 2015, the Medicare Administrative Contractors (MACs) review IDE studies to determine coverage.

    • The following MUST be submitted to CGS email J15IDE@cgsadmin.com
      • Protocol
      • IRB Approval Letter
      • FDA Approval Letter
      • CGS IDE Submission Form

    Trials approved by FDA after January 1, 2015, view listing on the CMS Approved IDE StudiesExternal Website MACs may require additional information to facilitate claims payment.

    • In order to update the Medicare Payment System e-mail to J15IDE@cgsadmin.com the following:
      • IDE Number listed in the CMS approval letter
      • Copy of CMS Approval
      • Facility Name and PTAN (Medicare Number)
    • Extensions: These no longer require CGS approval
    • Roster Changes: These no longer require CGS approval
    • Protocol Changes: please email a summary to CGS at J15IDE@cgsadmin.com

Clinical Trials, Prospective Studies, and Registries Coverage

Mandatory Reporting of National Clinical Trial (NCT) Identifier Numbers on Medicare Claims – Qs & AsExternal PDF

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

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.

Humanitarian Device Exemption

The following is a synopsis of CGS position on HDEs:

Though there is no prior approval process in traditional Medicare, CGS will consider case-by-case coverage for a Humanitarian Use Device when:

  1. The FDA has designated the device as a humanitarian use device (HUD).
  2. The FDA has approved the device for marketing under an HDE.
  3. The device has local IRB (Institutional Review Board) approval in the setting in which it is proposed to be used.
  4. Appropriate informed consent has been obtained from the patient.
  5. There exists a benefit category and the device is not statutorily excluded from coverage.
  6. There is no national or local coverage determination (NCD/LCD), which prohibits coverage.
  7. If there is a national or local coverage determination applicable to the device and/or its proposed use, the criteria noted in the NCD/LCD are met.
  8. The device is used in an episode of care that is reasonable and necessary for the diagnosis and treatment of an illness or injury or to improve the function of a malformed body member.

CGS requires providers seeking to use a HUD in the diagnosis and treatment of Medicare beneficiaries to submit the following information:

  1. CGS IDE Submission Form PDFPDF
  2. HUD Information is to be submitted to the CGS with an introductory letter.
  3. Details about the specific device, including documentation that the device is classified by the FDA as a HUD and has been approved by the FDA under an HDE.
  4. A description of the clinical scenario(s) in which the device will be used.
  5. A list of expected CPT/HCPCS codes expected to be billed in conjunction with the use of the device. In the event that an unlisted code will be used, the service to which it will apply must be described.
  6. A copy of the local IRB approval. The FDA requires that a HUD be used only in facilities that have established an IRB approval process responsible for supervising the use of the device and related services.

Upon receipt of the required documentation, CGS will review the submission and respond as soon as possible. Again, while there is no prior approval process in traditional Medicare, the process outlined above will help ensure Medicare beneficiaries are receiving covered services and have adequate access to care. Given the complexities of determining whether a device is reasonable and necessary when it has not been proven effective for its intended use, providers may wish to discuss this issue with their patients and consider the use of an Advance Beneficiary Notice of Noncoverage (ABN).

Additional information on the CMS beneficiary notice initiative is located on the CMS website. All coverage/payment decisions are made at the time of claims submission. Do not submit clinical records unless specifically asked to do so. Medical records, when submitted, should document why the benefits of use of the device outweigh the risks, considering both other available devices and other available therapies.

The 0624 revenue code should be used, along with applicable clinical trial coding, when the HDE has been reviewed and approved as a clinical trial meeting medical necessity.

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