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Based on a physician's knowledge of the risk of non-payment, Medicare's Advance Beneficiary Notice should be used when the physician believes the service is unlikely to be covered since it may not be medically necessary or reasonable. The ABN explains to the patient that even though Medicare does not pay for a certain item or service does not mean that the patient shouldn't have it. The –GA modifier should be used on the ABN. If –GA is not appended, the patient will be informed in the Explanation of Benefits that they are not responsible for payment.

Advance Beneficiary Notice shifts responsibility for payment

A recurring feature at the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting in Boston, Massachusetts, was the call for environmentally friendly practices worldwide, with the goal of decreasing the impact of ophthalmic surgeries on the planet.

A driving force in this movement is EyeSustain

 an organization dedicated to the development of such friendly environmental practices, that exists as a global coalition of eye societies providing education and resources to support sustainable practices in ophthalmology.

Here is a sampling of the ASCRS discussions on the topic.

Greening eye care: reducing ophthalmology’s environmental footprint

The presenters, led by first author Sarishka Desai, BA, described the EyeSustain platform and its 5-pronged mission: educate the global ophthalmic community about more sustainable practices, collaborate with industry to reduce our carbon footprint and surgical waste, support research and innovative solutions that reduce ophthalmology’s environmental impact, support advocacy and education about the public health impact of climate change, and collaborate with industry to reduce our carbon footprint and surgical waste.

Desai, of the University of Connecticut School of Medicine in Farmington, and colleagues presented EyeSustain’s approach to reducing the ophthalmic carbon footprint. She was joined in the study by Nitya Devireddy, BS, MPH, of Penn State College of Medicine in Hershey, Pennsylvania; Sofia Miguez, BA, of Yale School of Medicine in New Haven, Connecticut; and Barbara Erny, MD, of the Department of Ophthalmology at Stanford University in California.

The greenhouse gas data associated with health care are startling. Health care is responsible for 4.4% of all global greenhouse gas emissions, 71% of which arise from the manufacturing, use, and disposal of medical supplies. Ophthalmology has the highest procedural volume of any surgical specialty, with 50 million cataract surgeries expected to be performed globally each year by 2050, Desai reported.

In light of the procedural data, the authors highlighted 6 areas that are currently undergoing research and quality improvement initiatives through the EyeSustain system.

 of cataract surgeons and nurses by David Chang and Cassandra Thiel found that 93% of respondents believe that the trash associated with OR procedures is excessive, and that methods to reduce waste should be identified and implemented.

 encouraged regulatory agencies to allow electronic instructions for use be disseminated in lieu of the traditional paper instructions included with each cataract pack.

Ongoing projects spearheaded by EyeSustain members, including medical students and ophthalmology residents, are taking a look at educating surgeons and surgical staff about sustainability and the impact of OR waste, OR water consumption, and evaluation of flash sterilization associated with cataract surgery.

In recognition of the fact that medications in the OR represent an estimated $560 million in waste annually, a multisociety position paper

 recently formulated 3 key recommendations: topical drugs in multidose containers can be used for multiple patients in surgical facilities if proper guidelines are followed; topical drugs in multidose containers can be used until the manufacturer’s labeled date of expiration if proper guidelines are followed; and, when applicable, patients should be able to take their partially used medication home for postoperative use.

The Aravind Eye Care system’s low-carbon model from Madurai, India, uses alternate energy sources, transport, infrastructure, and equipment maintenance.

 Studying global systems of eye care and waste produced can provide a deeper understanding of the impact of hospitals and providers on climate change, as well as ideas on how western eye care systems can proactively reduce carbon emissions.

The EyeSustain platform includes ophthalmology-specific action steps for greening offices and clinics in collaboration with the 

Partnerships can be established with large manufacturers to reduce packaging, make instruments reusable, and streamline the manufacturing and distribution processes.

In addition to the impact of practice waste on the environment, EyeSustain also recommends studying the effects of climate change on the incidence rates of ophthalmologic conditions, including cataracts, allergic disease, and glaucoma, among others.

Desai and her colleagues recommended that institutions take the following steps:

Conduct a waste audit to quantify the carbon footprint of an institution’s OR emissions. This includes using the EyeSustain-Zasti Carbon Footprint Calculator, using the Sustainability Index for Disposables in Cataract Surgery calculator for cataract packs to evaluate the item-by-item potential for carbon dioxide savings, and surveying clinical staff to identify areas of perceived excess waste.

Identify key stakeholders at an institution and an enthusiastic, multidisciplinary team and completing the OR Sustainability Pledge (

), which has been completed by ambulatory surgery centers/hospital outpatient departments from 9 countries thus far.

Implement best practices; multisociety recommendations for sustainability are easily accessible at eyesustain.org and My Green Doctor for outpatient/clinic resources and local legislation using the American Academy of Ophthalmology Topical Medical Waste Reduction Act legislative template.

Using phacoemulsification waste to guide changes in surgical sustainability

Adjustments to improve the sustainability of ophthalmic surgical practice can have a large impact when scaled to case volume, according to author Margaret Tharp, BSc, who described this study at the ASCRS meeting. She and her coauthors Stella Protopapas, BA, MPH, and Minka Gill, BSc, are from the Indiana University School of Medicine in Bloomington, whereas David J. Palmer, MD, ABO, is from the Northwestern University Feinberg School of Medicine in Chicago, Illinois.

In their study, they sought to draw connections between results from a 24-hour waste audit at an outpatient surgical center and current resources available from EyeSustain to improve the sustainability of ophthalmic surgical practice.

The authors documented the extensive waste generated from 1 day of surgeries in an institution that included 13 phacoemulsification procedures, 5 plastic surgeries, 3 urologic surgeries, and 5 otolaryngologic cases. The waste products were sorted as medications (eg, propofol, eye drop containers), textiles (eg, surgical gowns, drapes), metals (eg, metal wiring, disposable instruments), and plastics (eg, hard, soft, wrappings).

When the amounts of the waste products were tallied, the authors found that “ophthalmology produced the greatest amount of waste in a single day relative to other operating specialties, despite producing the least amount of waste per case. Most ophthalmic waste was from textiles, hard plastics, and medications,” the authors reported.

The specific 13 phacoemulsification procedures resulted in 95.4 lb of waste broken down as follows: 18.5 lb of hard plastic, 5.5 lb of soft plastic, 8.3 lb of wrapping, 13.5 lb of medications, 41.2 lb of textiles, 6.7 lb of miscellaneous waste, and no metals. Compared with other operating specialties, ophthalmology produced the least amount of waste per case but the greatest amount of waste in total due to the relatively high case volume.

It has been reported that “discarded/unused pharmaceuticals from US cataract surgeries demonstrated waste of [approximately] $150 per case while generating carbon dioxide–equivalent emissions that approximated 25,000 to 100,000 flights from San Francisco, California, to Boston annually.

Small changes can have dramatic results. Tharp and colleagues suggested that the following would have positive consequences.

Revising the use of tetracaine bottles intraoperatively; for example, reusing the bottles between cases or sending the bottles home with patients

Optimizing packaging of surgical supplies and electronic instructions

Utilizing intravenous sedation to limit anesthesia gas carbon dioxide–equivalent emissions

Focusing on cutting waste also creates an opportunity to explore the practices of global leaders in sustainable eye care, such as the efforts of the Aravind Eye Hospitals, which provide similar surgical success rates at a fraction of the waste produced by US practices.

 A downside may be that such practices require significant reuse of materials, central sterilization, and stakeholder diligence, which can require complex interventions, according to Tharp. 

EyeSustain’s Surgical Facility Sustainability Pledge can serve as a guide for ophthalmologists to improve the sustainability of their practice in an approachable and lasting manner.

Factors contributing to the carbon footprint of cataract surgery

Omar Taboun, MSc, a medical student at Western University’s Schulich School of Medicine & Dentistry in London, Ontario, Canada, working under the direction of Netan Choudhry, MD, FRCSC, also described the negative impact of cataract surgery on the environment at the ASCRS meeting.

He commented, “We know that climate change can affect human health through various means, such as adverse weather events causing injury and exposure to pollutants [exacerbating] underlying health conditions. As health care providers, it is our responsibility to treat patients for their conditions that may ultimately be influenced by environmental factors. Counterintuitively, the health care sector is itself a greenhouse gas emitter,” Taboun said.

Surgery contributes significant emissions to the environment through the necessary materials and tools used during procedures. In addition, the need to maintain sterility increases waste.

The term footprint indicates the sum of all emissions direct and indirect resulting from this procedure, Taboun explained, the resultant value of which is typically reported in carbon dioxide equivalents

And although cataract surgery requires only a few minutes to complete, the procedural volume has increased exponentially over the past 2 decades,

Taboun and colleagues developed a 2-fold goal: they wanted to increase their understanding of the carbon footprint and waste accumulation to identify the primary contributors and pinpoint areas for improvement to enhance the sustainability of cataract surgery.

They conducted a literature search of PubMed, Google Scholar, and Medline to identify studies related to the carbon footprint and the elements of cataract surgery. The results yielded 6 studies, with 2 being the basis for this discussion,

He highlighted 3 main points extracted from the published data: the lowest footprint published was just under 6 kg of carbon dioxide equivalents; the highest published footprint was just over 180 kg of carbon dioxide; and the major factors contributing to the footprint include procurement of pharmaceuticals and materials, building and energy use, such as heating/cooling, lighting, electricity-powered tools, and travel by patients and staff to the location where the procedure is performed.

Taboun directed attention to centers that already have sustainable practices in place, such as the Aravind Eye Hospital, which reports the lowest footprint. These sustainable practices include the use of multiple operating tables in a single room; reusing gloves, gowns, and various medical equipment;

and using highly efficient autoclave settings.

Importantly, when these changes were implemented in the Aravind Eye Hospital,

 the rates of endophthalmitis remained comparable to other centers: 0.02% vs from 0.04% to 0.07% reported.

Taboun offered 3 ways that surgeons can offset the negative effects of cataract surgery on the environment—by focusing on procurement, energy use, and travel emissions.

Reduce emissions associated with procurement by collaborating with manufacturers to reduce packaging as much as possible and encouraging recycling in every OR.

Reduce building and energy use by incorporating renewable energy, such as solar panels, and more strategic lighting protocols and optimizing energy use within surgical centers.

Establish outreach clinics closer to more populous regions, whereby mostly staff members must travel, and patients less so, which will reduce travel emissions, along with performing bilateral procedures.

“Implementing sustainable practices, although challenging, will allow us to continuously provide this procedure and restore vision for millions of people at less of a cost to the environment,” Taboun said.

1. Chang DF, Thiel CL; Ophthalmic Instrument Cleaning and Sterilization Task Force. Survey of cataract surgeons’ and nurses’ attitudes toward operating room waste

. 2020;46(7):933-940.doi:10.1097/j.jcrs.0000000000000267

2. Schehlein EM, Hovasesian J, Shukla AG, Talley Rostov A, Findl O, Change DF. Reducing ophthalmic surgical waste through electronic instructions for use: a multi-society position paper. 

. 2024;50(3):197-200. doi:10.1097/j.jcrs.0000000000001381

3. Cleaning and Sterilization Task Force. Reducing topical drug waste in ophthalmic surgery: multisociety position paper

. 2022;48(9):1073-1077; doi:10.1097/j.jcrs.0000000000000975

4. Goel H, Wemyss TA, Harris T, et al. Improving productivity, costs and environmental impact in International Eye Health Services: using the ‘Eyeficiency’ cataract surgical services auditing tool to assess the value of cataract surgical services. 

. 2021 ;6(1):e000642. doi:10.1136/bmjophth-2020-000642. 2021

5. US EPA O. Greenhouse gas equivalencies calculator. United States Environmental Protection Agency. Updated January 2024. https://www.epa.gov/energy/greenhouse-gas-equivalencies-calculator

6. Gadani H, Vyas A. Anesthetic gases and global warming: [otentials, prevention and future of anesthesia. 

. 2011;5(1):5-10. doi:10.4103/0259-1162.84171

7. Thiel CL, Schehlein E, Ravilla T, et al. Cataract surgery and environmental sustainability: waste and lifecycle assessment of phacoemulsification at a private healthcare facility. 

. 2017;43(11):1391-1398. doi:10.1016/j.jcrs.2017.08.017

8. Pandey D, Agrawal M, Pandey JS. Carbon footprint: current methods of estimation. 

. 2011 ;178(1-4):135-160. doi:10.1007/s10661-010-1678-y

9. Pandey D, Agrawal M, Pandey JS. (2011). Carbon footprint: current methods of estimation. 

. 2011;178(1-4):135-160. doi:10.1007/s10661-010-1678-y

10 Rachmiel R, Trope GE, Chipman ML, Buys YM. Cataract surgery rates in Ontario, Canada, from 1992 to 2004: more surgeries with fewer ophthalmologists. 

11. Morris DS, Wright T, Somner JEA, Connor A. The carbon footprint of cataract surgery. 

. 2013;27(4):495-501. doi:10.1038/eye.2013.

12. Latta M, Shaw C, Gale J. The carbon footprint of cataract surgery in Wellington. 

13. Ravindran RD, Venkatesh R, Chang DF, Sengupta S, Gyatsho J, Talwar B. Incidence of post-cataract endophthalmitis at Aravind Eye Hospital: outcomes of more than 42,000 consecutive cases using standardized sterilization and prophylaxis protocols. 

. 2009;35(4):629-636. doi:10.1016/j.jcrs.2009.01.002

14, Pershing S, Lum F, Hsu S, et al. Endophthalmitis after cataract surgery in the United States: a report from the Intelligent Research in Sight registry, 2013-2017. 

. 2020;127(2):151-158. doi:10.1016/j.ophtha.2019.08.026

Organization eyes green practices, shifting ophthalmology landscape.

Minimizing the carbon footprint of ophthalmic surgeries

Atsena Therapeutics has announced dosing has been completed in Part A of the LIGHTHOUSE study, a Phase I/II clinical trial evaluating subretinal injection of ATSN-201 for the treatment of X-linked retinoschisis (XLRS).

According to the company, ATSN-201, a gene therapy product candidate, leverages AAV.SPR, the company’s novel spreading capsid, to achieve therapeutic levels of gene expression in photoreceptors of the central retina while avoiding the surgical risks of foveal detachment.

The LIGHTHOUSE study (NCT05878860) is a Phase I/II, open-label, dose-escalation and dose-expansion clinical trial evaluating the safety and tolerability of ATSN-201 in male patients ages six and older with a clinical diagnosis of XLRS caused by pathogenic or likely pathogenic mutations in 

. Enrollment for this study is ongoing. ATSN-201 has received Orphan Drug and Rare Pediatric Disease designations from the U.S. Food and Drug Administration.

XLRS is a monogenic X-linked retinal disorder caused by mutations in the 

 gene, which encodes retinoschisin, a protein secreted predominantly by photoreceptors. This protein localizes to the extracellular surface of rods, cones, and bipolar cells. XLRS is characterized by schisis—abnormal splitting of retinal layers—that results in impaired visual acuity uncorrectable with glasses, progressing ultimately to blindness. 

The condition primarily affects males and is typically diagnosed in early childhood. In the United States and European Union, approximately 30,000 males are affected by XLRS. Unfortunately, there are currently no approved treatments for this debilitating condition.

AAV.SPR: A novel gene therapy approach for XLRS

Atsena Therapeutics’ AAV.SPR is an innovative capsid designed to achieve lateral spread beyond the subretinal injection site, allowing safe and efficient transduction of the central retina. This is particularly beneficial for XLRS patients, as schisis cavities are most prominent in the macula.

In preclinical studies involving non-human primates, AAV.SPR demonstrated transgene expression far beyond the subretinal injection bleb margins, unlike standard AAV vectors, which are confined to these boundaries. At clinically relevant doses, AAV.SPR efficiently transduces foveal cones without requiring surgical retinal detachment and does not induce inflammation, marking a significant advancement in gene therapy for retinal diseases.

Kenji Fujita, MD, Atsena’s chief medical officer, said in a statement that 9 adults have been treated in Part A of the study in which three dose levels of ATSN-201 are being evaluated for safety and efficacy.

“We have seen both structural and functional benefits in patients treated at all dose levels,” Fujita said.

The company also reported that no serious adverse events related to treatment have been reported.

“Collecting data from Part A of the trial is an important breakthrough for Atsena because it validates the use of our novel capsid to effectively treat inherited retinal disease and it informs the safest and most effective path forward for Part B,” Fujita said. “We look forward to providing further updates from those patients early next year.”

Currently, there are no approved treatments for XLRS which is typically diagnosed in early childhood and primarily affects males. XLRS is characterized by schisis, or abnormal splitting of retinal layers, which causes impaired visual acuity that is not correctable with glasses and ultimately leads to blindness. Approximately 30,000 males in the U.S. and EU have this inherited retinal disease.

Patrick Ritschel, CEO of Atsena Therapeutics, said the company has started to hear positive anecdotes from those involved in the study.

“This marks a significant milestone for patients with XLRS as we push to bring a therapeutic option to individuals that otherwise have no approved treatment,” Ritschel said. “It also represents potential for individuals living with other inherited retinal diseases that could benefit from our novel capsid.”

1. Haserick B. Atsena Therapeutics – Atsena Therapeutics Announces Dosing Completed in Part A of Phase I/II Clinical Trial Evaluating Gene Therapy ATSN-201 to Treat X-linked Retinoschisis. Atsena Therapeutics. Published December 16, 2024. Accessed December 16, 2024. https://atsenatx.com/press-release/atsena-therapeutics-announces-dosing-completed-in-part-a-of-phase-i-ii-clinical-trial-evaluating-gene-therapy-atsn-201-to-treat-x-linked-retinoschisis/

In the LIGHTHOUSE study, Atsena Therapeutics is evaluating ATSN-201 gene therapy for X-linked retinoschisis, leveraging AAV.SPR capsid for central retina transduction without foveal detachment risks.

Atsena Therapeutics completes dosing in Part A of phase I/II clinical trial evaluating ATSN-201 to treat X-linked retinoschisis

A team of researchers has investigated the relationship between socioeconomic status (SES), as assessed by the Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry Social Vulnerability Index (SVI) and the Distressed Communities Index (DCI), and the characteristics of open globe injury (OGI).

Prognosis is primarily determined by injury severity, with lower presenting visual acuity and more posterior injuries linked to poorer visual outcomes. However, even eyes with no light perception at presentation may recover some visual function.

This retrospective study reviewed electronic medical records of patients treated for OGI at an academic Level I trauma center from May 2009 to March 2021. Patient data included age, injury date, injury mechanism, presenting visual acuity, presence of concomitant orbital wall fractures, and ocular trauma score (OTS). SVI and DCI scores were assigned based on the patient’s home zip code. Patients were categorized by the specific mechanism of injury and grouped into non-accidental versus accidental cases.

In addition to the severity of the primary injury, secondary injuries and complications play a significant role in poor outcomes, particularly proliferative vitreoretinopathy (PVR) and endophthalmitis. Endophthalmitis is a common complication following open globe injury, affecting up to 16.5% of patients. Systemic antibiotic prophylaxis is routinely used, although its evidence base is limited. In contrast, intraocular antibiotics, though less commonly employed, have stronger evidence supporting their efficacy in preventing infection.

Prompt primary repair of the injury can reduce the risk of endophthalmitis and may also improve visual acuity outcomes. While PVR cannot currently be prevented or treated with pharmacologic interventions, early vitrectomy within the first 4-7 days after injury may decrease the incidence of post-traumatic PVR. Timely surgical intervention remains a critical factor in mitigating long-term complications.

Ocular trauma training in Western ophthalmic surgical programs is often limited, and patients with ocular trauma frequently require the involvement of multiple subspecialists. Given the complexity of care, it is crucial for patients to have a coordinated management plan, with a lead clinician overseeing and ensuring comprehensive care across all specialties involved.

The researchers included 899 patients (75.0% male) in the study. The average ± SD age (years), SVI, and DCI scores were 44.8 ± 22.7, 0.418 ± 0.207, and 37.9 ± 24.0, respectively. Younger age was associated with higher DCI and lower OTS score (

 ≤ 0.002). Non-accidental trauma patients had lower OTS and higher SVI and DCI scores compared to accidental trauma (

 < 0.001); firearm-associated ocular injuries (FAOIs) were associated with higher SVI and DCI scores (

 = 0.040, respectively); domestic violence/assault was associated with worse OTS and higher DCI (

 < 001). Falls and sports-related injuries correlated with lower DCI scores (

The researchers noted that prompt primary repair, combined with intraocular administration of antibiotics, minimizes endophthalmitis risk and may optimize visual outcome. Optimal timing is based on retrospective studies, with 24 h being the most commonly used arbitrary cut-off, and it is likely that sooner is better.

Moreover, there is no evidence to support eye removal to prevent sympathetic ophthalmia when primary repair is possible, even in the most severely injured eyes.

“In our region, among patients with OGIs, lower SES scores were associated with younger age, FAOIs, and non-accidental injuries, including domestic violence/assault,” the researchers wrote. “Therefore, lower SES may be considered a risk factor for several distinct mechanisms of OGI.”

Socioeconomic status (SES), assessed via the Social Vulnerability Index (SVI) and Distressed Communities Index (DCI), influences open globe injury (OGI) characteristics. Lower SES correlates with younger age, firearm-associated injuries, and non-accidental trauma, including domestic violence. Injury severity, secondary complications like proliferative vitreoretinopathy (PVR) and endophthalmitis, and timely surgical intervention significantly impact prognosis. Intraocular antibiotics are more effective than systemic prophylaxis for endophthalmitis prevention. Coordinated care involving multiple subspecialists is essential due to the complexity of ocular trauma management, highlighting the need for comprehensive treatment plans.

A study investigating the impact of socioeconomic status (SES) on open globe injury (OGI) found that lower SES, measured by the Social Vulnerability Index and Distressed Communities Index, correlates with younger age, non-accidental injuries, and poorer visual outcomes in OGI patients.

L. Neal Freeman

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