Frequently asked questions

When should I contact Genzyme Biosurgery about a patient?
 How do I initiate the prior-authorization process?
 What should I include in the arthroscopic operative report to ensure proper reimbursement for the biopsy procedure?
 What should I include in the operative report to ensure proper reimbursement for the implant procedure?
When is the implant scheduled?
What is the cancellation policy?


When should I contact Genzyme Biosurgery about a patient?
As soon as you identify a patient as a clinically appropriate candidate for the autologous cartilage implantation (ACI) procedure, contact Genzyme Biosurgery Customer Care at 800-453-6948, Option #1.

How do I initiate the prior-authorization process?
The patient’s Carticel Care Coordinator (CCC) will submit the prior-authorization request to the insurance provider. The CCC's experience with CARTICEL will increase the likelihood of obtaining a prior-authorization and expedite the process time.

What should I include in the arthroscopic operative report to ensure proper reimbursement for the biopsy procedure?
Since authorization is often dependent upon documentation and since insurance company case managers rely on measurable objective data, it is important to provide very detailed information in the patient’s arthroscopic operative report. The following information must be highlighted:

  • Prior surgical procedures, particularly cartilage treatment procedures (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft)
  • Current symptoms and physical / functional limitations (unless these are noted in H&P)
  • Number of defects
  • Location(s) of defects
  • Size of defect(s) (estimated after debridement)
  • Grade of defect(s) (Using Outerbridge or ICRS scales, specify)
  • Health and stability of rest of the knee (Health of other articular cartilage in the knee, meniscal status, joint alignment and ligamentous stability)
  • Absence of osteoarthritis (CARTICEL® is not indicated for use in patients with OA)
  • Clearly state the medical necessity for and intent to treat with CARTICEL®.
  • Clearly state lack of other surgical options for the patient given their condition.
  • Clearly state that the patient was counseled about their condition and CARTICEL® as a treatment option and that the patient has made an informed decision about their care.

What should I include in the operative report to ensure proper reimbursement for the implant procedure?
Physicians’ offices should attach a copy of the operative report, or a narrative note, with each claim. Greater detail in the documentation of the implantation procedure increases the probability of appropriate reimbursement. Please include the following information in the operative report:

  • Preparation/debridement of defect site(s)
  • Harvesting of periosteal patch
  • Microsuturing technique
  • Testing for water tightness
  • Fibrin glue application
  • Implantation of chondrocytes
  • NOTE: Use the word "implant" not "transplant"

Physician office reimbursement will depend upon the unique contract established by the provider and the patient’s health plan. The physician office may want to consult with its contracting representative to determine specific reimbursement rates for implant procedures.

When is the implant scheduled?
Surgical dates may be discussed during the prior-authorization process. Your Carticel Care Coordinator will confirm the surgical date upon receipt of insurance approval of the CARTICEL implantation.

What is the cancellation policy?
CARTICEL is a customized product that requires careful calculations of the cell culturing time for each individual patient. The final culturing phase begins at the Manufacturing Date. At this time, the cells are taken from their cryopreserved state and put into a non-reversible, final cell culturing process to meet the implantation date requested. If a CARTICEL order is canceled for any reason on or after the Manufacturing Date the patient and the insurance company may be responsible for the cost of the cells. Please contact your CARTICEL Sales Representative or Carticel Care for detailed individualized information.


 

Was this content useful to you?:

Indications and Usage

Carticel® (autologous cultured chondrocytes) is an autologous cellular product indicated for the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft).

CARTICEL should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown.

CARTICEL is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis.

CARTICEL is not recommended for patients with total meniscectomy unless surgically reconstructed prior to or concurrent with CARTICEL implantation.

Important Safety Information

CARTICEL should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin.

It should not be used in patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb.

Pre-existing conditions, including meniscal tears, joint instability, or malalignment should be assessed and treated prior to or concurrent with CARTICEL implantation.

CARTICEL is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling CARTICEL.

Use of CARTICEL in children, patients over age 65, or in joints other than the knee has not yet been assessed.

The occurrence of subsequent surgical procedures (SSPs), primarily arthroscopy, following CARTICEL implantation is common. In the Study of the Treatment of Articular Repair (STAR), forty-nine percent (49%) of patients underwent an SSP on the treated knee, irrespective of their relationship to CARTICEL, during the 4-year follow up. The most common serious adverse events (≥5% of patients), derived from STAR, include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination, and osteoarthritis.

For more information on CARTICEL, please see the Package Insert (PDF).