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Breaking News: Two New Victories for End-Stage AMD Patients

Approved stampRecent decisions by the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have resulted in two very important victories for patients with end-stage age-related macular degeneration (AMD).

FDA Approval for Patients 65 Years and Older

VisionCare Ophthalmic Technologies, Inc. (VisionCare) is pleased to announce that the United States Food and Drug Administration have now approved the telescope implant for use in patients living with bilateral end-stage AMD who are age 65 or older. The telescope implant is the only FDA-approved surgical device for end-stage AMD and is Medicare eligible.

The telescope implant is the integral component of VisionCare’s comprehensive treatment program, CentraSight®, which helps patients follow the steps necessary for proper diagnosis, surgical evaluation, implantation and postoperative care. The telescope implant improves visual acuity and quality of life for suitable patients with AMD whose sight is permanently obstructed by a blind spot in their central vision. This blind spot makes it difficult or impossible to see faces, read, and perform everyday activities such as watching TV, preparing meals, and self-care.1 End-stage AMD is uncorrectable by any other treatment including glasses, vitamins, drugs, or cataract surgery and is associated with increased stress and depression as vision diminishes.2

“Despite all the great pharmacotherapy advances in AMD treatment, some patients will unfortunately progress to end-stage AMD where their straight ahead, central vision is permanently blocked,” said Dr. David Boyer, of Retina Vitreous Associates Medical Group, Beverly Hills, CA. “Once end-stage AMD patients have lost their central vision, cataract surgery will not provide them with as much benefit to their quality of life as the telescope implant.”

AMD is the leading cause of vision loss in Americans aged 60 and older, affecting an estimated 15 million people.3 Of those, 2 million Americans are living with end-stage AMD and that number will increase as the Baby Boomer cohort ages.

“We are pleased and excited about this important FDA decision,” said Allen W. Hill, President and Chief Executive Officer, VisionCare Ophthalmic Technologies. “We developed the telescope implant to help older adults who’ve missed seeing moments in their life and lost much of their independence. Now, younger individuals, those age 65 to 74, will also have access to this important therapy for treating end-stage AMD.”

The telescope implant is not a cure for end-stage AMD. As with any medical intervention, potential risks and complications exist with the telescope implant. Possible side effects include decreased vision or vision-impairing corneal swelling. The risks and benefits associated with the telescope implant are discussed in the Professional Use Information booklet.

1. “What is AMD?” Macular Degeneration Partnership. Accessed on September 19, 2014 at http://www.amd.org/what-is-macular-degeneration/.

2. Bennion, AE; Shaw, RL; Gibson, JM. “What do we know about the experience of age related macular degeneration? A systematic review and meta-synthesis of qualitative research” Social Science & Medicine. 75 (2012) 976-985.

3. Vision Problems in the United States. Prevent Blindness America. Accessed on September 19, 2014 at http://www.visionproblemsus.org/amd/amd-map.html.

CMS Establishes New Ambulatory Surgery Center Payment for Telescope Implant

VisionCare is pleased to announce that it has received final confirmation in CMS’ CY 2015 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center (ASC) Payment System Final Rule, posted October 31, 2014, that the telescope implant procedure (0308T) can be performed in both the ASC setting (designated as a device-dependent procedure beginning January 1, 2015) and HOPD setting with payment rates reflecting costs CMS has compiled from actual use.

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Now Available: Reimbursement Codes for 2015

Click here to download the reimbursement code reference guide.
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The outpatient surgical procedure for telescope implantation has been restricted to hospitals until now due to current reimbursement rules, despite the fact that approximately 80% of ophthalmic surgical procedures are performed in local ASCs. When the new designation for the APC (0351) code takes effect on January 1, 2015, reimbursement payment levels will increase overall and ASC payment levels will be comparable to those paid to hospital outpatient departments.

Learn more about the new reimbursement coding — for both ASC and HOPD settings — through a free informational webinar, presented by Byon Yeatts Director, Reimbursement and Health Policy, VisionCare Ophthalmic Technologies and Chet Kumar, Vice President of Sales and Market Development, VisionCare Ophthalmic Technologies.

To learn more about the webinar, read the article in the Learn and Connect section of this newsletter — and to register, click here.

[cta]The CentraSight treatment program and telescope prosthesis technology can help your end-stage AMD patients. Contact CentraSight online, by email, or by phone toll-free at 877-997-4448, option 2 to discuss how you can be part of the difference today.[/cta]