skip to content
Thank you for visiting First Coast Service Options' Medicare provider website. This website is intended exclusively for Medicare providers and health care industry professionals to find the latest Medicare news and information affecting the provider community.
To enable us to present you with customized content that focuses on your area of interest, please select your preferences below:
Select which best describes you:
Select your location:
Select your line of business:

By clicking Continue below you agree to the following:

LICENSE FOR USE OF "PHYSICIAN'S CURRENT PROCEDURAL TERMINOLOGY" (CPT), FOURTH EDITION End User/Point and Click Agreement: CPT codes, descriptions and other data only are copyright 2022 American Medical Association (AMA).

All Rights Reserved (or such other date of publication of CPT). CPT is a trademark of the AMA.
You, your employees, and agents are authorized to use CPT only as contained in the following authorized materials:
Local Coverage Determinations (LCDs),
Local Medical Review Policies (LMRPs),
Bulletins/Newsletters,
Program Memoranda and Billing Instructions,
Coverage and Coding Policies,
Program Integrity Bulletins and Information,
Educational/Training Materials,
Special mailings,
Fee Schedules;

internally within your organization within the United States for the sole use by yourself, employees and agents. Use is limited to use in Medicare, Medicaid, or other programs administered by the Centers for Medicare and Medicaid Services (CMS), formerly known as Health Care Financing Administration (HCFA). You agree to take all necessary steps to insure that your employees and agents abide by the terms of this agreement. Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CPT for resale and/or license, transferring copies of CPT to any party not bound by this agreement, creating any modified or derivative work of CPT, or making any commercial use of CPT. License to use CPT for any use not authorized here in must be obtained through the AMA, CPT Intellectual Property Services, 515 N. State Street, Chicago, IL 60610. Applications are available at the AMA website. Applicable FARS/DFARS restrictions apply to government use.

AMA Disclaimer of Warranties and Liabilities CPT is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. No fee schedules, basic unit, relative values or related listings are included in CPT. The AMA does not directly or indirectly practice medicine or dispense medical services. The responsibility for the content of this file/product is with CMS and no endorsement by the AMA is intended or implied. The AMA disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This agreement will terminate upon notice if you violate its terms. The AMA is a third party beneficiary to this agreement.

CMS Disclaimer: The scope of this license is determined by the AMA, the copyright holder. Any questions pertaining to the license or use of the CPT must be addressed to the AMA. End Users do not act for or on behalf of the CMS. CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE CPT. CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL CONTAINED ON THIS PAGE. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

AMA - U.S. Government Rights

This product includes CPT which is commercial technical data and/or computer data bases and/or commercial computer software and/or commercial computer software documentation, as applicable which were developed exclusively at private expense by the American Medical Association, 515 North State Street, Chicago, Illinois, 60610. U.S. Government rights to use, modify, reproduce, release, perform, display, or disclose these technical data and/or computer data bases and/or computer software and/or computer software documentation are subject to the limited rights restrictions of DFARS 252.227-7015(b)(2)(June 1995) and/or subject to the restrictions of DFARS 227.7202-1(a)(June 1995) and DFARS 227.7202-3(a )June 1995), as applicable for U.S. Department of Defense procurements and the limited rights restrictions of FAR 52.227-14 (June 1987) and/or subject to the restricted rights provisions of FAR 52.227-14 (June 1987) and FAR 52.227-19 (June 1987), as applicable, and any applicable agency FAR Supplements, for non-Department Federal procurements.

ADA CURRENT DENTAL TERMINOLOGY, (CDT)
End User/Point and Click Agreement: These materials contain Current Dental Terminology (CDTTM), Copyright © 2016 American Dental Association (ADA). All rights reserved. CDT is a trademark of the ADA.

THE LICENSE GRANTED HEREIN IS EXPRESSLY CONDITIONED UPON YOUR ACCEPTANCE OF ALL TERMS AND CONDITIONS CONTAINED IN THIS AGREEMENT. BY CLICKING ON THE BUTTON LABELED "ACCEPT", YOU HEREBY ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD AND AGREED TO ALL TERMS AND CONDITIONS SET FORTH IN THIS AGREEMENT.

IF YOU DO NOT AGREE WITH ALL TERMS AND CONDITIONS SET FORTH HEREIN, CLICK ON THE BUTTON LABELED "DECLINE" AND EXIT FROM THIS COMPUTER SCREEN.

IF YOU ARE ACTING ON BEHALF OF AN ORGANIZATION, YOU REPRESENT THAT YOU ARE AUTHORIZED TO ACT ON BEHALF OF SUCH ORGANIZATION AND THAT YOUR ACCEPTANCE OF THE TERMS OF THIS AGREEMENT CREATES A LEGALLY ENFORCEABLE OBLIGATION OF THE ORGANIZATION. AS USED HEREIN, "YOU" AND "YOUR" REFER TO YOU AND ANY ORGANIZATION ON BEHALF OF WHICH YOU ARE ACTING.

Subject to the terms and conditions contained in this Agreement, you, your employees and agents are authorized to use CDT only as contained in the following authorized materials and solely for internal use by yourself, employees and agents within your organization within the United States and its territories. Use of CDT is limited to use in programs administered by Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to ensure that your employees and agents abide by the terms of this agreement. You acknowledge that the ADA holds all copyright, trademark and other rights in CDT. You shall not remove, alter, or obscure any ADA copyright notices or other proprietary rights notices included in the materials.

Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CDT for resale and/or license, transferring copies of CDT to any party not bound by this agreement, creating any modified or derivative work of CDT, or making any commercial use of CDT. License to use CDT for any use not authorized herein must be obtained through the American Dental Association, 211 East Chicago Avenue, Chicago, IL 60611. Applications are available at the ADA website.

Applicable Federal Acquisition Regulation Clauses (FARS)\Department of restrictions apply to Government Use.

ADA DISCLAIMER OF WARRANTIES AND LIABILITIES: CDT is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. No fee schedules, basic unit, relative values or related listings are included in CDT. The ADA does not directly or indirectly practice medicine or dispense dental services. The sole responsibility for the software, including any CDT and other content contained therein, is with (insert name of applicable entity) or the CMS; and no endorsement by the ADA is intended or implied. The ADA expressly disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice to you if you violate the terms of this Agreement. The ADA is a third party beneficiary to this Agreement.

CMS DISCLAIMER: The scope of this license is determined by the ADA, the copyright holder. Any questions pertaining to the license or use of the CDT should be addressed to the ADA. End Users do not act for or on behalf of the CMS. CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE CDT. CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL COVERED BY THIS LICENSE. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

End Disclaimer


This website provides information and news about the Medicare program for health care professionals only. All communication and issues regarding your Medicare benefits are handled directly by Medicare and not through this website. For the most comprehensive experience, we encourage you to visit Medicare.gov or call 1-800-MEDICARE. In the event your provider fails to submit your Medicare claim, please view these resources for claim assistance.
Join eNews       En Español
Text Size:
YouTube LinkedIn Email Print
Send a link to this page
[Multiple email addresses must be separated by a semicolon.]
Last Modified: 7/26/2024 Location: FL, PR, USVI Business: Part A, Part B

Additional frequently asked questions about clinical trials and device coverage

Clinical trials background

Q: 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 external link.
Q: 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.
Q: 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.
Q: 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.
Q: 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 external link.
Q: 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.
Q: 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.
Q: 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 external link guidelines.
Q: Do I need to get approval from First Coast for transcatheter mitral valve repair (TMVR)?
A: No. TMVR external link is a procedure used to treat mitral regurgitation which is the most common type of heart valve insuffiency in the country. CMS issued NCD 20.33 external link, 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 external link.
Q: 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 external link.
Q: 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 external link webpage. Please reference the billing instructions for each NCD.
Q: 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 external link webpage.
Q:  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 external link and CMS IOM Pub. 100-04 Medicare Claims Processing Manual, Chapter 32, sections 68 & 69 external link for more details on reporting the 8-digit clinical trial number.
Q:  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?
A: Yes. Please follow the instructions available on our website for reporting routine costs.
Q:  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 external link.
Q: 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 website for more information.
First Coast Service Options (First Coast) strives to ensure that the information available on our provider website is accurate, detailed, and current. Therefore, this is a dynamic site and its content changes daily. It is best to access the site to ensure you have the most current information rather than printing articles or forms that may become obsolete without notice.