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December 18, 2015

Clarification of Clinical Trials

Who do I submit to:

Effective for Category A and B IDE studies approved by the FDA on or after January 1, 2015, interested parties (i.e., study sponsors) that wish to seek Medicare coverage must submit a request for review and approval to CMS.

  • CGS will have the responsibility of providing approval for system updates at the local level. In order to do this we require the documents listed below via J15IDE@cgsadmin.com.

J15 Medicare Providers will continue to submit requests to CGS for Category A and B IDE studies approved by the FDA prior to January 1, 2015. Please continue to submit to CGS for approval via J15IDE@cgsadmin.com.

Since humanitarian use devices (HUDs) with an FDA approved humanitarian device exemption (HDE) are not addressed in CMS Clinical Trial policies, local contractors may continue to make determinations about the coverage of HUDs

  • HUD submission requirements are outlined in the Clinical Trial section of the CGS Website
  • Submit requests using the CGS IDE Submission form, leaving sections not related to HUD blank.

Clinical trials for non-significant risk devices (devices which do not require an FDA-approved IDE) are the responsibility of the hospital's IRB.

  • While these devices do not require an FDA-approved IDE, many of the FDA-approved IDE requirements apply to these non-significant risk devices (e.g., they may not be legally marketed). Medicare contractors are responsible for making the coverage determinations on non-significant devices that are the responsibility of the hospital's IRB.
  • Contractors will apply the same coverage criteria, where appropriate, to these devices as are applied to FDA-approved IDE Category A and B IDE devices.

All other trials not listed above (i.e. 501k, IND, Feasability etc ) must be submitted to CGS.

  • CGS will have the responsibility of providing approval for system updates at the local level. In order to do this we require the documents listed below via J15IDE@cgsadmin.com.

Claim Submissions:

  • Effective for dates of service on or after January 1, 2008, practitioners will no longer bill a QV modifier to identify the device. Instead, practitioners will bill a Q0 (numeral 0 versus the letter O) modifier (Investigational clinical service provided in a clinical research study that is in an approved clinical research study) along with the IDE number.
  • Effective for claims with dates of service on or after January 1, 2014, it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under CED.This number is listed prominently on each specific study's page of www.clinicaltrials.govExternal Website website and is always preceded by the letters "NCT."
  • The Q1 modifier is line item specific and must be used to identify items and services that constitute medically necessary routine patient care or treatment of complications arising from a Medicare beneficiary's participation in a Medicare-covered clinical trial. Items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the clinical management of the patient are not covered and may not be billed using the Q1 modifier. Items and services that are not covered by Medicare by virtue of a statutory exclusion or lack of a benefit category also may not be billed using the Q1 modifier. When billed in conjunction with the V70.7/Z00.6 diagnosis code, the Q1 modifier will serve as the provider's attestation that the service meets the Medicare coverage criteria (i.e., was furnished to a beneficiary who is participating in a Medicare qualifying clinical trial and represents routine patient care, including complications associated with qualifying trial participation).

NOTE: For information regarding Medicare coverage related to IDEs in Medicare Advantage plans, refer to Pub. 100-16, Medicare Managed Care Manual, chapter 4, section 10.7.2.

References:

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