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The proposed 2022 Medicare Physician Fee Schedule and Quality Payment Program rules released by Centers for Medicare and Medicaid Services (CMS) may usher in a wide range of changes, including a 3.75% reduction in the conversion factor used to calculate payments to physicians.

However, according to the Surgical Care Coalition, the proposal by CMS fails to address pending cuts to surgical care and therefore continues to threaten patient care by reaffirming these previously imposed cuts.

The cuts are the result of a reduction that is necessary to keep Medicare payments budget neutral. At the end of 2020, Congress passed a one-year fix that prevented the cuts due to take effect in 2021. Without additional intervention, the cuts will go into effect Jan. 1, 2022.

CMS is proposing to cut the Medicare conversion factor—the basic starting point for calculating Medicare payments—for CY2022 by 3.75%. This year's cut is reinstating the cut that Congress prevented last year, which further emphasizes the need for continued congressional intervention to protect patient care.

The Surgical Care Coalition noted that updates to the conversion factor have failed to keep up with inflation, and it will be joined by the American Academy of Ophthalmology to ensure the final version of the rule is fair to ophthalmologists and surgeons. 

"CMS' proposed 2022 Medicare Fee Schedule has a huge effect on ophthalmology's ability to run a successful ophthalmology practice, which has one of the highest Medicare beneficiary bases," said George A. Williams, MD, AAO Senior Secretary for Advocacy. "The academy is proud to partner with the Surgical Care Coalition and will work over the next few months in an effort to ensure that the final version of the rule is fair to ophthalmologists and surgeons."

The proposal’s release is followed by a 60-day public comment period closing on Sept. 13, which will culminate in CMS' release of the final rule, which is expected to be announced by November for implementation on Jan. 1, 2022. As a result, the proposed rule could be subject to change before a funal rule is released.

Glaukos Corp. has stepped up to discuss the proposal, noting that the proposed rule and accompanying addenda include payment rates for two new Category I Current Procedural Terminology (CPT) codes, including 669X2 for non-complex cataract extraction in combination with the insertion of an aqueous drainage device and 669X1 for complex cataract extraction in combination with the insertion of an aqueous drainage device.

Category I CPT Codes 669X2 and 669X1 will replace Category III codes 0191T and 0376T as the primary codes that physicians will use to seek reimbursement utilizing Glaukos’ trabecular micro-bypass technologies (

) when used as approved in combination with cataract surgery.

Applying the CMS 2022 Proposed Rule’s assigned total facility Relative Value Units (RVUs) and associated conversion factor, Glaukos estimated a proposed 2022 physician fee for Category I CPT Code 669X2 of approximately $565.23, representing incremental physician fee payment for the insertion of an aqueous draining device of approximately $34.25 versus the proposed 2022 physician fee of approximately $530.98 for Category I CPT Code 66984 (non-complex cataract surgery alone).

“We are aware of and extremely disappointed with CMS’ proposed 2022 physician fees for the new Category I codes that cover our sight-saving trabecular micro-bypass technologies used in combination with cataract surgery,” said Thomas Burns, Glaukos’ president and CEO. “While this is unwelcomed and unexpected news that we believe is unjustified, we are eager to engage with our key ophthalmic societies and are committed to exploring every option during the public comment period in hopes that medical providers across our network are paid appropriately for conducting these types of procedures.”

This announcement does not include the Medicare Outpatient Prospective Payment System (OPPS) Proposed Rule for Calendar Year 2022, which will include proposed facility fee payments for services furnished in both the hospital outpatient department (HOPD) and ambulatory surgical center (ASC) settings. Glaukos expects the 2022 Medicare OPPS Proposed Rule to be released by CMS over the coming days to weeks.

David B. Hoyt, MD, FACS, executive director of the American College of Surgeons, noted that while CMS is taking notable strides to improve health equity and access to care, the proposed rule maintains the cuts to surgical care that Congress stopped last year.

“These cuts harm the care patients need and deserve, which is the opposite of what CMS is trying to achieve," he said. "Without congressional action, surgical care faces a significant payment cut and threatens patient access to critical treatments and procedures. All patients deserve a health care system that invests in surgical care and does not create uncertainty year after year."

Articles

AAO, Surgical Care Coalition teaming up to ensure the final version of the rule is fair to ophthalmologists and surgeons as one company is expressing its disappointment in the proposal. 


CMS 2022 Physician Fee Schedule includes payment cut 

A team of Mount Sinai investigators found that gene therapy in mouse models showed promise in preventing vision loss or blindness from serious retinal injury including optic nerve damage, and from retinal disease including diabetic retinopathy and glaucoma.

 could shift the paradigm in treatment for patients at risk of major vision loss from retinal degenerative diseases, which currently have no cure. 

The study is supported by the National Eye Institute (NEI), which is part of the National Institutes of Health, along with the Research to Prevent Blindness and The Harold W. McGraw Jr. Family Foundation.

According to the study, the team focused on retinal ganglion cells, which process visual information by sending images to the brain. These cells can degenerate as a result of retinal injury and retinal disease. 

The team of researchers demonstrated how reactivation of a key enzyme known as CaMKII and its downstream signaling in retinal ganglion cells through a gene therapy approach provided robust protection against further vision loss or impairment in multiple disease and injury models.

"Neuroprotective strategies to save vulnerable retinal ganglion cells are desperately needed for vision preservation," senior author Bo Chen, PhD, said in a statement. "We uncovered evidence for the first time that CaMKII is a key regulator of the survival of retinal ganglion cells in both normal and diseased retinas, and could be a desirable therapeutic target for vision preservation in conditions that damage the axons and somas of retinal ganglion cells."

Chen is an associate professor of ophthalmology and neuroscience, and director of the Ocular Stem Cell Program at the Icahn School of Medicine at Mount Sinai. 

He also is the McGraw Family Vision researcher at Icahn Mount Sinai, and a winner of the Pew Scholars in the Biomedical Sciences award given to young investigators showing outstanding promise.

Glaucoma is the leading cause of irreversible visual impairment worldwide, affecting 76 million people, some of whom will progress to blindness despite aggressive treatment to reduce the pressure in their eyes. 

Investigators noted that neuroprotective strategies to preserve the RGC’s axons and somas (and thereby prevent further vision loss are needed.

The investigators studied whether CaMKII could play such a therapeutic role. 

They tested the enzyme across a wide range of injury and disease animal models, including optic nerve damage, excitotoxicity (where nerve cells are destroyed by the overactivation of glutamate receptors that result in damage to the cell structure), and two glaucoma models that mimicked the pathophysiology of human disease with both high and normal intraocular pressure.

The team learned that CaMKII regulated the survival of retinal ganglion cells across many of these pathologies, and that in the small-animal excitotoxicity model, insults to the retinal ganglion cell’s somas or optic nerve injury to its axons led to inactivation of CaMKII and its downstream signaling target CREB (or cAMP response element binding protein).

“Intriguingly, we found that reactivation of CaMKII and CREB provided robust protection for retinal ganglion cells,” Chen noted in the statement, "and that CaMKII-mediated protection slowed down the disease progression in both glaucoma models."

That reactivation was made possible by a gene therapy approach deployed by the researchers to introduce a more active type of 

 into the original retinal ganglion cells to boost their activity. 

, with a mutated amino acid, was transferred to the targeted cells through an adeno-associated viral vector, a FDA-approved gene delivery system common to the growing field of gene therapy.

 could indeed be a valuable therapeutic target to save retinal ganglion cells and preserve vision in treating potentially blinding diseases like glaucoma," Chen said in the statement. "The fact that manipulation of CaMKII would involve a one-time transfer of a single-gene adds to its vast potential to treat serious retinal conditions in humans.”

Chen also pointed out that the next step is testing this in larger animal models, which may pave the way for starting clinical trials.

According to the news release, Mount Sinai has filed patent applications for this technology through Mount Sinai Innovation Partners (MSIP), the commercialization arm of the health system. 

MSIP is in active discussions with multiple companies to help advance this treatment to the clinic.

1 Bo Chen, PhD, et al. Preservation of vision after CaMKII-mediated protection of retinal ganglion cells. 

 July 22, 2021; httos://doi.org/10.1016/j.cell.2021.06.031

Investigators uncovered evidence that CaMKII could prove to be a desirable therapeutic target for vision preservation in conditions that damage the axons and somas of retinal ganglion cells.

Study: Gene therapy could preserve vision in patients with retinal disease, serious retinal injury

"may actually be detectable in the eyes of patients, in the form of nerve damage that can be seen in the cornea.

"Long COVID" is the term used to identify a wide range of symptoms experienced by up to 30 percent of patients long after they have recovered from acute SARS-CoV-2 infection. 

These symptoms include brain fog, headaches, fatigue, loss of taste and/or smell, and more.

long COVID may be detected in the form of nerve damage that can be seen in the cornea.

Investigators pointed out that the nerve damage in the cornea can be detected by corneal confocal microscopy (CCM). 

According to the study, the investigators used the technology to identify corneal nerve damage and increased dendritic cells in cases of long COVID. 

They compared the results of 40 patients with previous COVID-19 infections against CCM observations of 30 healthy individuals who never had the disease.

The team, led by lead author Gulfidan Bitirgen, MD, from the Department of Ophthalmology at Necmettin Erbakan University in Konya, Turkey, noted that CCM could be used to detect long COVID through corneal scans of a subset of the COVID-19 group showing greater corneal nerve fiber damage and loss, along with higher counts of dendritic cells, than healthy participants.

"To the best of our knowledge, this is the first study reporting corneal nerve loss and an increase in DC density in patients who have recovered from COVID-19, especially in subjects with persisting symptoms consistent with long COVID," Bitirgen wrote in the study.

The investigators acknowledged that the work was a small observational study that could not confirm that COVID-19 actually caused the corneal abnormalities in the patients, the possible links show potential evidence of how SARS-CoV-2 infection may contribute to neurological and neuropathic problems.

Moreover, the investigators explained that this could be the result of potential disruptions to healthy nerve fiber development, leading to an increase in dendritic cells summoned as part of our immune response.

"These findings are consistent with an innate immune and inflammatory process characterized by the migration and accumulation of DCs in the central cornea in a number of immune mediated and inflammatory conditions," the investigators explained. "Further study of the relative change in mature and immature DC density and corneal nerves in COVID-19 patients over time may provide insights into the contribution of immune and inflammatory pathways to nerve degeneration."

The team found that the mean time after the diagnosis of COVID-19 was 3.7±1.5 months. 

Patients with neurological symptoms 4 weeks after acute COVID-19 had a lower CNFD (p = 0.032), CNBD (p = 0.020), and CNFL (p = 0.012), and increased DC density (p = 0.046) compared with patients in the control group.

Moreover, the patients without neurological symptoms had comparable corneal nerve parameters, but increased DC density (p = 0.003). 

There were significant correlations between the total score on the NICE long COVID questionnaire at 4 and 12 weeks with CNFD (ρ = −0.436; p = 0.005, ρ = −0.387; p = 0.038, respectively) and CNFL (ρ = −0.404; p = 0.010, ρ = −0.412; p = 0.026, respectively).

The investigators also found that the patients with more severe cases of COVID-19 often exhibited greater corneal nerve damage. 

They maintained that it could be possible that the eye abnormalities found in the study stem from the way the disease presents in patients.

According to the team, additional research with a greater number of patients will be needed to follow up on initial findings, but the results offer additional evidence of how closely eye health is connected to overall health.

“Corneal confocal microscopy identifies corneal small nerve fiber loss and increased DCs in patients with long COVID, especially those with neurological symptoms. CCM could be used to objectively identify patients with long COVID,” the investigators concluded. “Corneal confocal microscopy may have clinical utility as a rapid objective ophthalmic test to evaluate patients with long COVID.”



1 Gulfidan Bitergen, MD, et al; Corneal confocal microscopy identifies corneal nerve fibre loss and increased dendritic cells in patients with long COVID, 

A team of investigators used corneal confocal microscopy to identify corneal nerve damage in cases of long COVID. 


‘Long COVID’ may be linked to nerve damage in the cornea

Source: Holland Foundation for Sight Restoration


 with a goal of establishing Centers of Excellence (COEs) throughout the country that would specialize in site restoration procedures.

The Holland Foundation is the only foundation created to address the significant unmet medical need of corneal transplantation for patients who have severe ocular surface disease while enabling surgeons the resources to provide the treatment across the country, according to a news release.

It is estimated that 60,000 people are born with birth defects that cause progressive blindness due to ocular surface failure. Another 100,000 people will have a chemical or thermal accident each year that impairs their sight.

Because corneal blindness results from severe ocular surface disease in which routine corneal transplantation is not effective, an opportunity exists for patients to regain their vision with ocular surface stem cell transplantation, also known as The Cincinnati Technique™.

"We specialize in patients that have injuries like acid or alkaline injuries, or chronic, severe medical problems that cause them to scar the surface of the eye," said Edward Holland, MD, director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati, in the release.

"The most severe patients end up with loss of the skin-producing stem cells called the limbal stem cells, which results in corneal scaring and then, unfortunately, severe blindness," he said. "To treat these patients, we transplant the specialized surface cells of the eye from a relative or a deceased donor. Patients then require oral antirejection medications similar to organ transplant patients."

But most potential patients do not have access to effective treatment, so ocular surface stem cell transplantation surgeries are rarely performed.

The nonprofit foundation will fund additional locations, training and support for those who cannot afford treatment in order to ensure patients across the country have access. 

Ultimately, COE's are envisioned in selected cities and regions of the country - Southern California, Minnesota, Virginia, Texas, Massachusetts and New York.

Each COE will specialize in sight restoration procedures and each will be in proximity to existing networks of nephrologists and other appropriate specialists.

"Ed Holland is one of the only doctors that does this particular technique," said Foundation Board Chairman Robert Dempsey, in the news release. "Supporters of the Foundation have the opportunity to make a difference - to give the gift of sight to patients who without the financial resources of the Foundation will live a life in which they are blind."

The foundation will provide “tool kits” to physicians across the country to implement the protocols and approach that the nonprofit's team have created in Cincinnati.

The Holland Foundation for the Restoration of Sight will:

Provide support and clinical care for patients with severe ocular surface disease throughout the nation.

Increase access to Ocular Surface Transplantation and the necessary follow up care to restore sight to those in need.

Educate clinicians on the diagnosis and treatment of patients with severe ocular surface disease.

Train clinicians on how to build a regional Ocular Surface Transplantation Center and create the infrastructure needed to perform the Ocular Surface Transplantation surgery and the necessary follow up care for successful long-term prognosis.

This announcement was made at the 2021 ASCRS annual meeting.

OT Staff Reports

Articles

Study: Gene therapy could preserve vision in patients with retinal disease, serious retinal injury

‘Long COVID’ may be linked to nerve damage in the cornea

Holland Foundation for Sight Restoration launched to provide life-changing eye surgeries

CMS 2022 Physician Fee Schedule includes payment cut