The FiberCel™ Patient and Physician Support Program (“Program”) is a program to support patients required to seek additional testing or treatment related to the FiberCel™ Recall and their healthcare providers. Information provided by this Program is intended to focus on patient support to ensure patients are seeking – and not delaying – any medically necessary treatment as a result of the FiberCel™ Recall. This Program delivers on the patient-focused mission of medical device companies and distributors to promote patient safety and well-being, while responding to any product events.
FiberCel™ Recall Patient & Physician Support Center
Resources and support to guide reimbursement requests are available to help answer questions.
NAMSA, a confidential third-party Contract Research Organization (“CRO”), has been retained to support patients confirmed to have been implanted with units from the June 2, 2021 recalled single lot of FiberCel™ Viable Bone Matrix (VBM) (“FiberCel™ Recall”). NAMSA can assist patients and their healthcare providers to request reimbursement for qualified out-of-pocket expenses related to testing and treatment as a result of the FiberCel™ Recall.
Please review the following information and contact NAMSA with any questions.
For more information about the FiberCel™ Recall https://www.fda.gov/vaccines-blood-biologics/recalls-biologics/urgent-voluntary-notification-fibercel-fiber-viable-bone-matrix-fibercel-lot-number-nmds210011
FiberCel™ Patient and Physician Support Program
Information about reimbursement for qualified out-of-pocket medical expenses
TB testing and treatment associated with the FiberCel™ Recall should be covered and reimbursed through a combination of private and public resources. These resources will include funding under the patient’s insurance plan (private or public), as well as any available TB approved funding resources through the county or state health departments where the patient resides.
To be considered eligible for the FiberCel™ Patient and Physician Support Program (“Program”), patients will be required to: (1) certify they have sought ongoing TB support and reimbursement from their local or state health department resources; (2) submit all claims through any available private or public health insurance plan they are eligible to participate; (3) submit supporting documentation through the NAMSA confidential portal that detail any qualified out-of-pocket expenses they may be seeking for reimbursement, following exhaustion of steps one (1) and two (2) above.
Qualified out-of-pocket expenses are defined as expenses associated with testing and treatment related to the FiberCel™ Recall that are not also covered by the health department or available insurance.
Additional limitations may apply. Reimbursements are subject to review and approval.
If you do not have health insurance or are ineligible for TB funding through your state or local health department, you will be required to file a certificate verifying your uninsured status.
How can I receive more information about the Patient and Physician Support Program?
Detailed patient support packets are being distributed through affected hospital accounts and medical providers. Contact your hospital accounts risk manager or medical provider for more information. Additional questions related to the patient support packet can be sent to RS.Fibercel@medtronic.com.
What should I be doing now ?
- Do not delay treatment.
- Continue working with your state or local health department TB caseworker and your medical provider to ensure you are following all medical advice and recommendations.
- Confirm your provider has submitted all claims for your testing, care and treatment related to the FiberCel™ Recall through any available insurance you are eligible for.
- Save any Explanation of Benefit Statements (EOBs) or other relevant communication from your insurance carrier, unpaid medical bill or receipts related to any care or treatment as a result of the FiberCel™ Recall.
- Apply for and receive funding determination within your local or state board of health for eligible coverage of testing and treatment expenses.
Need Further Assistance?
A NAMSA representative can assist with any questions or if you need a reasonable accommodation such as assistance completing the intake form or uploading verification documentation such as Explanations of Benefits (EOBs) or receipts. Contact us at (833) 256-2357.
The Program is voluntary and is not intended to be an admission of liability of any kind or a waiver
by individuals participating in the Program. All rights reserved.
The Program Sponsors have retained a third-party Contract Research Organization (CRO) to assist with administration of the Program. The CRO retained is NAMSA, formerly referred to and also known as Syntactx.