Advancing wet AMD care through actionable insights between office visits

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The Notal Vision Monitoring Center provides a new patient management paradigm that aims to help improve personalized care for wet AMD patients by delivering ophthalmologists never-before-seen disease insights between office visits.

Provided By the Notal Vision Monitoring Center

A comprehensive remote patient monitoring service that leverages innovative home-based OCT technology and AI to make reviewing patient data easy and intuitive.

The patient self-operated SCANLY Home OCT device captures spectral-domain OCT images in a 10 by 10-degree area centered on the point of fixation. A scan typically takes less than one minute per eye to perform.1 Images are automatically transmitted via a built-in wireless connection to the Notal Health Cloud for analysis.

The proprietary, AI (artificial intelligence)-based Notal OCT Analyzer (NOA) segments and estimates the volume of hypo-reflective spaces (HRS)—important biomarkers in managing neovascular age-related macular degeneration (nvAMD)—on OCT images. Physicians can review data, set eye-specific notification criteria, including volume thresholds, and receive notifications through a HIPAA-compliant web portal.

The SCANLY Home OCT Monitoring Program is provided by the Notal Vision Monitoring Center, a pioneer in ophthalmic digital healthcare with more than 10 years of remote patient monitoring experience. Led by practicing ophthalmologists and staffed by certified ophthalmic professionals, we do all the work you and your staff don’t have the time to do:


Set your practice up for easy referral

Verify patients’ benefits and insurance eligibility

Educate and enroll your patients into the program

Ship the easy-to-use SCANLY Home OCT to your patients

Provide continuous white-glove support

Monitor adherence to recommended daily scanning

Physician-led Personalized Care

I am Interested, What's Next?

We are working to bring SCANLY to doctors and patients in a sustainable and responsible fashion.

In addition to educating doctors through podium presentations, peer-reviewed publications, and offering demos at key meetings, we are laying a solid foundation for implementing SCANLY into everyday workflows. This includes establishing preferred practice patterns, cultivating a seamless patient experience, and working towards consistent reimbursement and coverage.

Ophthalmologists can partner with the Notal Vision Monitoring Center today to better understand how the remote monitoring model fits into your practice with the ForeseeHome AMD Monitoring Program. The program is a proven way to help you improve long-term outcomes of anti-VEGF therapy through early detection of wet AMD between office visits.3

Consider offering the Medicare covered ForeseeHome to your intermediate AMD patients, or wet AMD patients with an intermediate AMD fellow eye, so your practice is ready to implement SCANLY monitoring for wet AMD patients in the future. Learn more on how to refer to the Notal Vision Monitoring Center.

Follow us on LinkedIn to stay up to date with the latest on SCANLY, and complete the form below to let us know if you’re interested in offering the SCANLY Home OCT Monitoring Program to your patients when it becomes available.

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Frequently Asked Questions

What is SCANLY Home OCT?

A patient self-setup and self-operated tele-connected device for daily imaging between office visits, giving physicians remote access to images visualizing intra- and subretinal hypo-reflective spaces, which are important biomarkers in wet, or neovascular, AMD (nvAMD) management​.

Is the SCANLY Home OCT safe, efficacious, and easy to use?

In two pivotal US trials involving over 500 patients, Notal Vision demonstrated that SCANLY is a safe and efficacious way to visualize intra- and subretinal hypo-reflective spaces.1,2 The user-friendly nature of SCANLY is illustrated in findings from the longitudinal pivotal study of nvAMD patients with a mean age of 77 years.1 97% of all participants were able to successfully obtain OCT images at home. The participants performed a total of 5,426 scans in the study eye, with 97% of all imaging attempts being successful. An adherence rate of 5.9 scans/week was observed. The self-imaging by patients took 48 seconds on average.1

Click here to see important safety information

How will I view my patient’s scan data?

Once your patient is enrolled in the SCANLY Home OCT Monitoring Program, you will use the SCANLY Portal, a secure web-portal supporting patient management through data review, notification threshold setting and reporting.

What data helps me review SCANLY Home OCT images?

Our technology harnesses the power of artificial intelligence using the proprietary, AI-based Notal OCT Analyzer (NOA) to make the review of up to daily images easy and intuitive. NOA performs fully automated detection and segmentation of retinal hypo-reflective spaces including intra-retinal hypo-reflective spaces (IRO), subretinal hypo-reflective spaces (SRO), and total hypo-reflective spaces (TRO) from SCANLY macular cube scans. Trajectories of TRO volume over the monitoring period allow for the identification of hypo-reflective spaces statuses, and trends in TRO volume estimations, between office visits. In addition, NOA generates (i) annotated B-scans, with areas of retinal hypo-reflective spaces shown color-coded according to hypo-reflective space type, (ii) en-face hypo-reflective space projections (separated by IRO and SRO), and (iii) ranking B-scans by order of largest to smallest hypo-reflective spaces areas, all to support intuitive image review.

Are there any fees or costs to my practice?

No. As a digital healthcare provider, the Notal Vision Monitoring Center bills the patient, or their insurance, for the SCANLY Home OCT Monitoring Program. Practices are not responsible for storing equipment or training patients on how to use the device.

Will I be able to bill for reviewing patient data?

A set of established and dedicated CPT codes for remote OCT (0604T, 0605T and 0606T) allow physicians and the monitoring center to bill for their services every 30 days.*

Will insurance cover the program for patients?

We are working with the retinal specialist community and Medicare Administrative Contractors to establish coverage and payment for remote OCT billing codes.


References:

  1. https://clinicaltrials.gov/study/NCT049074
  2. https://clinicaltrials.gov/study/NCT05202587
  3. Mathai M, Reddy S, Elman MJ, Garfinkel RA, Ladd B, Wagner AL, Sanborn GE, Jacobs JH, Busquets MA, Chew EY; ALOFT study group. Analysis of the Long-term Visual Outcomes of ForeseeHome Remote Telemonitoring: The ALOFT Study. Ophthalmology Retina. 2022 Oct;6(10):922-929. Doi:10.1016/j.oret.2022.04.016

*DISCLAIMER: All coding and reimbursement information supplied is for illustrative purposes only and does not constitute specific advice. The final decision for coding of any procedure must be made by the healthcare provider after considering the medical necessity of the services and supplies provided as well as all applicable federal, state, and local laws or regulations. Reasonable effort has been made to ensure the accuracy of the information provided, however, all coding and reimbursement information is subject to change without notice, and specific payers may have their own coding and reimbursement requirements and policies. Finally, all submissions to the federal government must be truthful and not misleading and require full disclosure for the reimbursement of any service or procedure. Please contact your local payer for interpretation of the appropriate codes to use for specific purposes. Notal Vision specifically disclaims any responsibility arising from the use of this illustrative information. CPT® is a registered trademark of the American Medical Association (AMA). CPT coding is copyrighted by the AMA. All rights reserved.

FDA Intended UseSCANLY Home OCT has not been approved by FDA for use other than described in the following Intend Use: The Notal Vision Home Optical Coherence Tomography (OCT) System is an Artificial Intelligence (AI)-based Home Use device indicated for visualization of intraretinal and subretinal hypo-reflective spaces in a 10 by 10-degrees area centered on the point of fixation of eyes diagnosed with neovascular age-related macular degeneration (NV-AMD). In addition, it provides segmentation and an estimation of the volume of hypo-reflective spaces. The Notal Home OCT device is intended for imaging at home between regularly scheduled clinic assessments and not intended to be used to make treatment decisions or replace standard-of care regularly scheduled examinations and clinical testing as needed, including in-office imaging and assessments for changes in vision, by an ophthalmologist.

Warnings and Precautions

SM-270.2