Understanding clinical trials and device coverage
Clinical trials background
What regulatory guidance addresses devices and clinical trials in the Medicare program?
For guidance pertaining to devices and clinical trials, please refer to the CMS references below.
- CMS IOM Pub.100-02, Benefit Policy Manual, Chapter 14
- CMS IOM Pub.100-03, National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, section 310.1
- CMS IOM Pub.100-04, Claims Processing Manual, Chapter 32, section 68
- MLN Matters® Article, MM8401 - Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims
For additional information on approved clinical trials or registry information, please visit Clinicaltrials.gov
Do I need to get approval from First Coast for an IDE?
No. However, please follow our submission requirements for IDEs in order to have our Part A claims processing system updated.
How can I check the status of an IDE submission?
As required by CMS guidelines, you will receive a response within 45 business days from the date your submission is received. If you have not received a response after 45 business days, please contact First Coast at medicalaffairs@guidewellsource.com.
Please define modifiers “Q0” and “Q1.”
A: The modifier “Q0” is defined as an investigational clinical service provided in a clinical research study that is in an approved clinical research study (devices). The modifier “Q1” is defined as a routine clinical service provided in a clinical research study that is in an approved clinical research study (services).
I have an “investigational drug” that is IND approved. Do I need to submit any information to First Coast for approval?
A: No. If the investigational drug is approved by the Food and Drug Administration (FDA), follow the NCD 310.1 for Routine Costs in Clinical Trials.
What is a humanitarian use device (HUD)?
A: An HUD is a medical device the FDA has approved for clinical investigation in accordance with its approved indication (s) for a different indication.
How do I get First Coast to approve a HUD?
A: You do not need to submit an application for approval to First Coast for a HUD. Simply file the claims as appropriate keeping the medical documentation on file.
What is a humanitarian device exemption (HDE)?
A: The HDE is the term used when filing an application with the FDA for a device exempt from the premarket approval application effectiveness requirements.
Do I submit non-significant and significant risk devices to First Coast for approval?
A: No, submissions for non-significant device investigations are made directly to the IRB of each participating institution. Studies of devices posing a significant risk require both FDA and IRB approval. Learn more by reviewing the Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors- Significant Risk and Nonsignificant Risk Medical Device Studies.
What does the phrase “compassionate use” mean?
A: The compassionate use provision allows access for patients whom the treating physician believes the device may provide a benefit in treating their disease, but do not meet the clinical trial requirements.
How do I get First Coast to approve compassionate use?
A: First Coast does not approve compassionate use for a single patient or small group. The FDA must approve before compassionate use occurs.
Do I need to get approval from First Coast for transcatheter aortic valve replacement (TAVR)?
A: No. TAVR, also known as transcatheter aortic valve implantation, became nationally covered in 2012. Therefore, the billing and processing of TAVR claims is different from IDEs that require First Coast or CMS approval prior to billing for associated routine costs. Please follow our Transcatheter aortic valve replacement claim submission guidelines.
Do I need to get approval from First Coast for transcatheter mitral valve repair (TMVR)?
A: No. TMVR is a procedure used to treat mitral regurgitation which is the most common type of heart valve insufficiency in the country. CMS issued NCD 20.33, which allows for coverage of TMVR under coverage with evidence development with certain conditions. In addition, the TMVR website reflects the Medicare approved registry and Medicare approved clinical trial which have been reviewed and determined to meet the requirements of coverage. Billing and coding guidelines can be found in the CMS Pub. 100-04, Medicare Claims Processing Manual, Chapter 32, Section 340.
Where can I find information about Medicare coverage related to IDEs in Medicare Advantage plans?
A: You can find more information about coverage related to IDEs in Medicare Advantage plans in CMS Pub. 100-16, Medicare Managed Care Manual, Chapter 4, section 10.7.2.
How are clinical studies approved under coverage with evidence development (CED)?
A: In NCDs requiring CED, Medicare covers items and services in CMS-approved CED studies. Approved CED studies are posted on the CMS Coverage with Evidence Development webpage. Please reference the billing instructions for each NCD.
Is there reimbursement for sham procedures during clinical trials?
A: While the items and services furnished as placebo controls may not be considered reasonable and necessary under section 1862 (a)(1)(A) of the statute because they have no health benefit, these items and services can be necessary to conduct a scientifically valid clinical study. As such, these services can be covered under section 1862(a)(1)(E) when furnished in the context of a clinical study where coverage is necessary to preserve the scientific integrity of the study. For more information, please see the CMS Coverage with Evidence Development webpage.
Am I required to report the NCT number on my IDE/clinical trial claim?
A: Yes. It is mandatory to report a clinical trial number (NCT), on claims for items/services provided in clinical trials/studies/registries, or under coverage with evidence development (CED). Claims submitted without the 8-digit clinical trial number will be returned as unprocessable. The associated IDE number must still be reported on the claim form as well as the mandatory 8-digit NCT number.
Please refer to MLN Matters article, MM8401 and CMS IOM Pub. 100-04 Medicare Claims Processing Manual, Chapter 32, sections 68 & 69 for more details on reporting the 8-digit clinical trial number.
If I am billing for a Category III (“CAT III”) device along with routine costs associated with the device that is an exemption and only approved by the FDA when used as part of a clinical trial, do I follow the reporting guidelines for Investigational Device Exemption (IDE)Studies?
Yes. Please follow the instructions available on our website for reporting routine costs.
Is it my responsibility to determine if the services I am billing are an exemption and can only be billed within a clinical trial?
A: Yes. There are many devices and/or services that are covered only if performed during a clinical trial. It is the sponsor’s duty to provide this information to the institution billing for the services. They should also ensure the services billed are within the effective start date of a clinical trial. All of this and more can be found on clinicaltrials.gov.
Do I need to send First Coast an IDE submission for Carotid Artery Stent (CAS) or Non- Carotid Artery Stent studies?
A: You no longer need to submit information to us for either of these studies. Please review our Pre-market approval (PMA), PMA post-approval studies, premarket notification (PMN) 510(k) and 510(k) post-approval extension studies webpage for more information.