Since 2020, the number of people with glaucoma worldwide has surpassed 80 million and is expected to pass 111 million by 2040.^1,2 With minimal onset symptoms, early glaucoma often goes unnoticed and undiagnosed and, if left untreated, can leave the patient irreversibly blind. According to the World Health Organization, glaucoma is the second leading cause of blindness in the world.¹ Yet, despite the damaging effects of this disease, the Centers for Disease Control and Prevention estimate that at least 50% of people with glaucoma don’t even realize they have it.³

While early diagnosis and intervention can significantly reduce the risk of vision loss for patients suffering with glaucoma, recent research suggests that measuring IOP in a clinical setting may not always provide the full picture for this chronic disease. Studies show that diurnal and nocturnal IOP rhythms fluctuate, with spikes often occurring outside traditional office hours and often in the early waking hours.⁴ In addition to elevations in IOP, wide fluctuations of IOP have also been shown to contribute to glaucoma progression.^5-7 These fluctuations can occur over a 24-hour period as well as over weeks to months, yet traditional glaucoma management typically has us basing our management plan on a single IOP measurement captured in the clinic every 3-4 months.

This disconnect between office tonometry and out-of-office maximum IOP and fluctuations leads to ignorance about a patient’s true range of IOP exposure and can delay identification of critical fluctuation trends and IOP spikes, which might otherwise influence the overall glaucoma treatment and management plan. In this article, I will discuss how home tonometry can be instrumental in detecting occult IOP spikes and fluctuations, especially outside of traditional clinic hours, and how to establish reimbursement models.

THE BENEFITS OF HOME TONOMETRY

While more research is needed to fully understand why the timing and extent of IOP spikes and fluctuations differ among patients, the need for comprehensive IOP data in some patients naturally raises the value of methods that can tabulate IOP outside of the traditional clinic hours or between office visits. Additional real-world IOP information can be shocking in terms of the magnitudes of IOP spikes that then can inform clinical decision making, including assessments of the effectiveness of various therapeutic interventions.^4,8

Home self-tonometry with the iCare HOME2 (Icare USA) offers a collaborative, patient-centered approach to measure diurnal IOP, giving glaucoma specialists the ability to gather more IOP measurement data at the patient level and learn a patient’s actual maximum IOP. The iCare HOME2 is an FDA-cleared prescription hand-held device that enables patients to measure their IOP at home at variable times of the day and/or night, in sitting, reclined or supine position, without the need for local anesthesia, eyedrops or specialized skills. iCare HOME measurements are relatively comparable to Goldmann applanation tonometry.⁹

The iCare HOME2 connects via Bluetooth to patients’ smartphones and can upload data to the cloud in real time. The data is immediately available for review by the clinician, but making the data available for both the patient and provider to view in real time is up to the discretion of the provider and patient.

Beyond a quick learning curve, IOP data can be captured at any time and accessed by the patient and physician in real time via the cloud. Videos, Zoom and patient ambassadors with live chat are available to work with patients, provide advice and instruct them.

Favorable Medicare coverage and payment policies for remote physiological monitoring offer a new avenue for providers to provide better eye care to patients, get reimbursed for analyzing and discussing the data with patients (more on that below) as well as making remote medication changes and/or scheduling follow up.

CASE STUDY: THE ICARE HOME TONOMETER IN THE MONITORING OF IOP PRE- AND POST-SLT

 

 

A 41-year-old male patient with glaucoma in his left eye presented with significant progression of disease on retinal nerve fiber layer and elevated IOPs that was detected with the iCare HOME tonometer outside of the office and with large range of fluctuation. SLT was decided upon. The red line is his IOPs prior to SLT. IOP values in the left eye range between 15 mm Hg and 29 mm Hg. Following SLT, IOP of the left eye stabilized, and fluctuation and max IOP reduced with the highest values recorded of 14 mm Hg. This case shows the value of iCare HOME in monitoring IOP pre- and post-SLT.

BETTER DATA IMPROVES GLAUCOMA CARE

As a glaucoma specialist, I have discovered that utilizing a comprehensive treatment plan, including remote patient monitoring (RPM) with an iCare HOME2 tonometer device, has been instrumental in filling in those gaps of critical IOP measurements, especially regarding risk stratification for new patients and changes in treatment options.

Through this collaborative approach, I have found that measuring IOP at different times of day and night can be beneficial for both my patients and me. I have not only been able to identify IOP spikes (sometimes a doubling in IOP), but also changing responses to medication and surgery, including encapsulation of blebs and tubes with loss of IOP control. I now look to not only lower IOP but flatten the curve, thus reducing that range of variability in IOP.

While it’s not always clear why IOP spikes occur, the iCare HOME2 tonometer enables us to gather information that may suggest why a patient’s glaucoma is progressing despite having seemingly controlled IOP in the office. We have all had those patients all too frequently.

In a recent study, patients with normal tension glaucoma who used an iCare HOME tonometer to measure fluctuating IOP outside of normal office hours saw spikes that were not captured during routine office visits. As a result of these findings, 56% of patients in the trial received a change in treatment by their provider.¹⁰

I have had a similar experience with many patients in my care. By having patients use an iCare HOME2 tonometer and gathering additional data that I couldn’t capture in the traditional clinic setting, we have identified night-time IOP rises to the high 20s mm Hg in a few patients with advanced disease in what we thought was “controlled” normal-tension and/or open-angle glaucoma. As a result of those findings, I was able to rapidly shift treatment and recommend surgery sooner to several of these patients.

It has been amazing to now see IOPs flatten with no fluctuation in several of these patients who ended up undergoing shunting procedures such as trabeculectomies and tube shunts. We are also seeing variable IOP control depending on the surgical procedure used. Several published case reports^8,11,12 have emphasized the importance of having access to this information and have demonstrated how not all treatments deliver similar IOP results.

In contrast, I have seen patients with ocular hypertension and IOPs in the low 20s mm Hg in my clinic, who have not shown damage over years; I’ll ask them to use the iCare HOME2 tonometer for a week, and we’ll see no IOP fluctuation. Their IOP stays relatively flat according to measurements taken over 7-14 days at numerous times of day. While home monitoring may lead us to realize that we need to be more proactive, it may also give us the confidence needed to continue observing a patient without treatment.

Beyond chronic glaucoma IOP measurements, a home tonometer can also be a highly useful tool for facilitating safe follow-up of patients residing in remote and rural areas after surgical procedures. I have used the iCare HOME2 to enable IOP monitoring of patients after trabeculectomies, valves/tubes and sustained-release Durysta (Allergan) implants. Studies have also found that a significant reduction in mean IOP after selective laser trabeculoplasty (SLT) could be detected when providing self-tonometry devices to patients after their procedure.¹²

The data from the six-year LiGHT study demonstrate that SLT resulted in slower progression as compared to topical drops.¹³

I wonder if the reason SLT is effective in slowing progression is that SLT may be more effectively flattening IOP fluctuations and reducing IOP spikes. We are currently conducting a multicenter study to help address that hypothesis. (For a case study of the iCare HOME tonometer monitoring IOP pre/post SLT, see page 25.)

EXPANDING PATIENT ACCESS

The iCare HOME2 tonometer is available for purchase or rental through MyEyes.net with a prescription from the provider. It is also available through other companies and academic centers. As of January 2023, insurance does not reimburse patients for the medical device. I believe, as do my glaucoma colleagues, that this is a valuable device for monitoring a chronic, progressive disease. As glaucoma providers, we will be looking to work with payers along with the device manufacturer, Icare, to try to get the iCare HOME2 covered by insurance providers.

If the patient has a health plan through an employer, they can leverage a flexible spending account (FSA) to rent or purchase the iCare HOME2 with pre-taxed money. This device is eligible for reimbursement with FSAs, health savings accounts and health reimbursement accounts as a qualifying durable medical equipment (DME).¹⁴ Unfortunately, DME are not eligible for reimbursement with limited-purpose FSAs and dependent-care FSAs as of now.

On the MyEyes.net website, patients can upload their prescriptions and make a payment, and the device will be shipped to them within a few days. Patients can also access iCare HOME2 teaching videos and instructional information along with available one-on-one tutorials with ophthalmic technicians and patient ambassadors to facilitate the device’s usability. No anesthetic is needed, and sterile probes are provided.

REIMBURSEMENT MODEL

As a result of the pandemic and the rising need to expand access to health care for patients who live in rural areas, telehealth and RPM have grown to be considered the new standard of care in many medical settings. Patients now expect to be able to connect with their physicians in between office visits, and glaucoma patients are no different.

As more and more providers are implementing RPM clinics to better manage chronic conditions like glaucoma, the iCare HOME2 tonometer will be an important tool in this growing trend.

With the Centers for Medicare & Medicaid Services (CMS) viewing RPM as a means of keeping more patients healthier and reducing the overall long-term costs of chronic diseases like glaucoma, providers can now use several RPM codes for reimbursement.

The following are current RPM codes and billing that can be applied to glaucoma and most ocular conditions:¹⁵

1. Initial setup (99453): This is a one-time claim and reimbursement for instructing the patient on performing home monitoring and transmitting data with the iCare HOME2. Reimbursement for this code is up to $18.77.
2. Device (99454): This is a monthly claim and reimbursement for the iCare HOME2 equipment or software used to perform the RPM test. Reimbursement for this code is up to $62.44 per month.
3. Monitoring (99457): This is a monthly claim and reimbursement to review tests for a cumulative total of 20 minutes per month. Reimbursement for this code is up to $51.61 per month.
4. In-person or telehealth visit (99212-99215, 92012-92014): When an office visit or telehealth visit is needed, submit extra visit code(s) as usual.

For providers, the ability to remotely monitor IOP data can help improve the quality and timeliness of interventions and outcomes for glaucoma patients. This is especially important given that early detection and treatment of glaucoma is critical for preventing vision loss and other serious complications.

In addition to improved patient care, RPM also has the potential to increase access to care by making it easier for patients who live in rural or remote areas to get regular check-ups with their provider.

PUTTING IT ALL TOGETHER

Implementing the iCare HOME2 tonometer as part of a comprehensive glaucoma management plan and giving patients the ability to measure their IOP from home allows them to be fully engaged and take a more proactive role in the management of their glaucoma. For providers, the iCare HOME2 allows us to receive access to a larger dataset of patient measurements that allows for more personalized, evidence-based and informed treatment decisions around how and when a management plan should and can be adjusted.

Paired with the cloud, the device also gives providers an easy and effective RPM system that they can use to improve the quality of care and reduce delayed and sometime long-term costs associated with less than optimal glaucoma management. With reimbursement codes available through CMS, this technology makes home tonometers more accessible than ever before. I believe that the iCare at-home use will continue to grow, providing critical IOP information that can lead to improved outcomes for people living with glaucoma or other ocular conditions. OM

REFERENCES

1. Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014;121(11):2081-2090.
2. Kapetanakis VV, Chan MP, Foster PJ, Cook DG, Owen CG, Rudnicka AR. Global variations and time trends in the prevalence of primary open angle glaucoma (POAG): a systematic review and meta-analysis. Br J Ophthalmol. 2016;100(1):86-93.
3. Centers for Disease Control and Prevention. Don’t let glaucoma steal your sight! https://www.cdc.gov/visionhealth/resources/features/glaucoma-awareness.html . Published Nov. 24, 2020. Accessed Dec. 22, 2022.
4. McGlumphy EJ, Mihailovic A, Ramulu PY, Johnson TV. Home Self-tonometry Trials Compared with Clinic Tonometry in Patients with Glaucoma. Ophthalmol Glaucoma. 2021;4(6):569-580.
5. Musch DC, Gillespie BW, Lichter PR, Niziol LM, Janz NK; CIGTS Study Investigators. Visual field progression in the Collaborative Initial Glaucoma Treatment Study the impact of treatment and other baseline factors. Ophthalmology. 2009;116(2):200-207.
6. Hasegawa K, Ishida K, Sawada A, Kawase K, Yamamoto T. Diurnal variation of intraocular pressure in suspected normal-tension glaucoma. Jpn J Ophthalmol. 2006;50(5):449-454.
7. Gao F, Miller JP, Miglior S, et al. A Joint Model for Prognostic Effect of Biomarker Variability on Outcomes: long-term intraocular pressure (IOP) fluctuation on the risk of developing primary open-angle glaucoma (POAG). JP J Biostat. 2011;5(2):73-96.
8. Levin AM, McGlumphy EJ, Chaya CJ, Wirostko BM, Johnson TV. The utility of home tonometry for peri-interventional decision-making in glaucoma surgery: Case series. Am J Ophthalmol Case Rep. 2022;28:101689. Published Sept. 7, 2022.
9. Liu J, De Francesco T, Schlenker M, Ahmed II. Icare Home Tonometer: A Review of Characteristics and Clinical Utility. Clin Ophthalmol. 2020;14:4031-4045. Published Nov. 23, 2020.
10. Sood V, Ramanathan US. Self-Monitoring of Intraocular Pressure Outside of Normal Office Hours Using Rebound Tonometry: Initial Clinical Experience in Patients With Normal Tension Glaucoma. J Glaucoma. 2016;25(10):807-811.
11. Rojas CD, Reed DM, Moroi SE. Usefulness of Icare Home in Telemedicine Workflow to Detect Real-World Intraocular Pressure Response to Glaucoma Medication Change. Ophthalmol Glaucoma. 2020;3(5):403-405.
12. Awadalla MS, Qassim A, Hassall M, Nguyen TT, Landers J, Craig JE. Using Icare HOME tonometry for follow-up of patients with open-angle glaucoma before and after selective laser trabeculoplasty. Clin Exp Ophthalmol. 2020;48(3):328-333.
13. Gazzard G, Konstantakopoulou E, Garway-Heath D, et al. LiGHT trial: 6-year results of primary selective laser trabeculoplasty versus eye drops for the treatment of glaucoma and ocular hypertension [published online ahead of print, 2022 Sep 16]. Ophthalmology. 2022;S0161-6420(22)00732-1.
14. HealthCare.gov . Using a Flexible Spending Account FSA. https://www.healthcare.gov/have-job-based-coverage/flexible-spending-accounts/ . Accessed Dec. 22, 2022.
15. Wicklund E. CMS to reimburse providers for remote patient monitoring services. mHealth Intelligence. https://mhealthintelligence.com/news/cms-to-reimburse-providers-for-remote-patient-monitoring-services . Published Nov. 2, 2018. Accessed July 12, 2019.

BARBARA WIROSTKO, MD, FARVO, is a board-certified glaucoma specialist, clinician researcher, holding a clinical adjunct professor position at the University of Utah in Ophthalmology at Moran Eye Center and in the Dept. of Biomedical Engineering. As a serial entrepreneur, Dr. Wirostko is the chief medical officer and co-founder of Qlaris Bio as well as the co-founder and medical director for MyEyes.net . Follow her on LinkedIn at www.linkedin.com/in/barbarawirostko/ . Disclosures: Dr. Wirostko is a consultant and advisor to Icare and is the co-founder and medical director for MyEyes.net .