CentraSight, the implantable telescope for macular degeneration, is now available! CMS (Centers for Medicare and Medicaid Services) has approved the telescope for those patients with macular degeneration meeting the eligibility criteria for the surgical procedure.
Medicare/Medicaid will cover the cost of the implant and the surgery in certain patients as October 1, 2011! For now, the procedure has a designation of a transitional pass-through payment, that is, CMS will approve the procedure for 2-3 years until enough payment data can be collected.
The Telescope Improves Vision
To achieve this milestone, Visioncare, the parent company, needed to show that the implantable telescope for macular degeneration met several criteria;
- FDA Approval
- CMS deems reasonable and necessary
- Device offers Substantial Clinical Improvement
FDA Approval: VisionCare received FDA approval for their telescope last August.
Substantial Clinical Improvement may be difficult to attain as the device must surpass some steep challenges. In order to achieve this status, one of the following situations must be true;
- the new device must be better than other available treatments
- the device improves the ability to diagnose a condition
- the device significantly improves the patient (i.e. clinical outcomes)
Availability of the CentraSight Telescope
For now, according to my contact at VisionCare, CentraSight will be offered at the locations where the original clinical trials were performed. This has been their plan all along. With time, as more physicians become trained, the availability will widen.
What Does This Mean? This is the first real step to helping patients with significant visual loss in both eyes. The surgery to insert the “telesope” is similar to cataract implantation, yet the CentraSight will modify the images so more of the retina surrounding the macula is utilized for vision.
While patients with either form of the disease might be candidates, this is the first FDA sanctioned “therapy” for patients with severe loss of vision from dry ARMD.
This is not a cure or a “fix” for loss of central vision, however, the telescope does improve function for those that have no central vision from the disease and can lead to am improvement in the quality of life.