Glaucoma
Spring 2024
by Ellen Stodola
Editorial Co-Director
In 2023 into early 2024, glaucoma surgeons were facing a potentially disastrous reimbursement situation when five Medicare Administrative Contractors (MACs) proposed and finalized limiting coverage of several MIGS procedures in their Local Coverage Determinations (LCDs). These LCDs would have gone into effect at the end of January, but because of extensive advocacy efforts from ASCRS, the American Glaucoma Society (AGS), and the American Academy of Ophthalmology (AAO), the LCDs were retired, and it was announced that there would be no change in the coverage at this time.
This issue started in early 2023. Throughout the year, ASCRS worked collectively with AAO and AGS to meet with the MACs (National Government Services (NGS), Palmetto, CGS, Wisconsin Physician Services (WPS), and Noridian) about these LCDs.
This advocacy included numerous letters and individual meetings with the MACs, as well as attending and speaking at every single open meeting and public listening session held by the five MACs. When a MAC releases a proposed LCD, one of the requirements is to hold an open meeting. ASCRS, AAO, and AGS had a physician representing the three organizations at every meeting, from each service area covered by the MAC, speaking up against these changes and how that specific policy would affect their patients.
After the draft LCDs were finalized towards the end of 2023, ASCRS and the other organizations participated in “grasstops” advocacy by asking physician members who had close, personal relationships with key members of Congress to reach out and ask them to advocate on their behalf to CMS to put pressure on the MACs to retire the policies.
The MACs ultimately made the decision to retire their LCDs for MIGS, scoring a huge win for our doctors and patients.
Leon Herndon Jr., MD, president of AGS and the former chair of the ASCRS Glaucoma Clinical Committee, was involved. He noted the collaboration between ASCRS, AGS, AAO, and Outpatient Ophthalmic Surgery Society to look at what was in these proposed LCDs and to refute the proposed changes. “It was a long process,” he said, which involved numerous meetings and calls to try to clarify the LCDs and educate the MACs. “It was an all-hands-on-deck exercise, and I think if we had not had these collaborative efforts, then we probably would not have been successful.”
ASCRS Government Relations Committee Chair Parag Parekh, MD, said that being involved in these issues should be something that every doctor does. “We went into this field to treat patients and not get our hands dirty with politics, but sadly, it’s followed us. We have a choice to make. Either you stand up and fight for your patients and yourself or just give up and let insurance and the government do what they want,” he said. “We’re surgeons; we’re people of action; and to me, it should be in our character to want to fight back and take some action and have some kind of measurable improvement in our situation.”
Dr. Herndon said reimbursement changes come up frequently, and it’s common for procedures to be cut. In this case, they would not have been covered. But he said this really boils down to patient care issues. “You’re taking valued procedures from the surgeons’ hands that they think are best to keep the patients from going blind,” he said.
Dr. Herndon said that, despite these LCDs being retired, it’s important to be vigilant going forward. “Advocacy is so important,” he said. “It really boils down to having a patient-centric approach.” Also key, he said, is to have better research available in the future. He noted long-term efforts to form a consortium of researchers to put together studies so there will be data to back up these procedures in the future. “In the short term, I’ve gotten a better education about the process and opportunity to educate colleagues about the process,” he said. “The key driver is research and an evidence-based approach.”
Dr. Parekh said that the focus on the MIGS codes and reimbursements started a few years ago. And because of these innovative, effective techniques, doctors did more and more MIGS, like goniotomy and canaloplasty and even some of the new variations on cyclophotocoagulation.
This rapid adoption of surgeons to the MIGS procedures has led to large growth in utilization of these procedures, which caught the attention of the MACs, said Nathan Radcliffe, MD.
These are amazingly important procedures, Dr. Parekh said. “The best work in the field of glaucoma in the last 10 years, in my opinion, has been MIGS,” he said. “The reason, to me, that the volume has gone up so much is because doctors are realizing how effective these procedures are, and how topical treatments, like eye drops, shouldn’t be the go-to first line.” This is more of an interventional mindset, which Dr. Parekh sees as a good thing. “I think that’s a much better way to look at the disease, and it’s a much better way to treat the disease.”
Dr. Parekh said he believes patients would also rather have their disease treated without the need for drops. He described cost and compliance issues (the need to remember to take the medication daily or even several times per day). “There are also so many side effects to these eye drop medications. It’s much better to have it treated so precisely and effectively with surgical intervention,” he said.
Because of these advancements, Dr. Parekh said this has spurred a new way of looking at the disease and treatment options, and the carriers are still looking at it in an old way. If you look at the LCDs, they basically implied that drops are fantastic and the gold standard, Dr. Parekh said. The LCDs also perhaps saw drops as a less expensive option and way to control costs.
Many of the procedures that were in question with the LCDs for MIGS, Dr. Parekh said, are procedures that have been done in the past but now there’s a new device. When the device gets approved, it’s a different FDA approval, he said, so all those devices went through proper FDA channel to get approved, but those requirements did not include a randomized controlled trial. “There’s plenty of other data, but the MACs are fixated on that fact, which was not a requirement for approval.”
If there haven’t been enough wakeup calls in the past with cataract surgery cuts and all the Medicare cuts that happened over the past 10–20 years, Dr. Parekh said this most recent situation with MIGS might be the wakeup call for ophthalmologists.
To be involved effectively, Dr. Parekh said physicians need to be informed. Read the Washington Watch Weekly, which highlights some of the key issues, Dr. Parekh said. Donate to the eyePAC, which is the ASCRS political action committee, he added. “We elect our friends to Congress,” Dr. Parekh said. “Two of our greatest friends are Mariannette Miller-Meeks, MD, and Rand Paul, MD, in the House and Senate. This is not about being conservative or liberal…it is about who helps us and our patients. If we can have more friends like that in Congress, then those types of elected officials can put pressure on CMS, on the FDA, and hold hearings and write letters of inquiry.”
Another important part, Dr. Parekh said, is to get to know your local senator or congressman both on the national and state level. “As doctors and small business owners, we are pillars of the community. We are a source of good jobs, and we help the community see better and live better, and if something bad is happening to doctors, it affects the whole district. If we don’t speak up, they’ll think everything is fine. You have to speak up to let them know.”
“We know now, at least for today, those LCDs have been retired by the MACs,” Dr. Radcliffe said. “Looking back on the experience and having been a part of the team that was writing letters and compiling data and preparing presentations to fight these LCDs, we’ve learned a few things.”
The first lesson, in Dr. Radcliffe’s opinion, is that, when it comes to payers, procedures are only as good as the high-quality data shows. “When it comes to the MIGS procedures, we literally have perhaps 1,000 published articles that support their use and also show very consistent outcomes with good pressure reduction and good medication reduction,” he said. “Medicare is more fixated on the IOP reduction, whereas clinicians are very happy with the medication reduction because we can tell our patients are happier to be on fewer meds, and that’s something that’s lost a little on the payers.” Fortunately, he said, in advocating to the MACs, ASCRS, AAO, and AGS were able to use high-quality data that had been produced to demonstrate the validity of the procedures, in particular goniotomy. There was a prospective, multicenter, randomized study that demonstrated that goniotomy was at least equivalent to the placement of a trabecular bypass stent, Dr. Radcliffe said, and this is the type of data that goes a long way in terms of persuading Medicare and other payers to support the use of a procedure.
“Surgeons who are able to participate in these high-quality prospective randomized clinical studies should do so and should recognize that they’re helping their field, they’re helping patients, and ultimately advancing the quality of glaucoma care in a very meaningful way.”
The second lesson he took from this experience was that advocacy matters, and complacency and fatalism/cynicism are harmful. “When I sat in on a feedback session that was held by the WPS MAC, there were perhaps 10 different LCD policies that had been proposed in different fields of medicine, and it was very notable to me that, for most of the LCD proposed changes, there were no clinicians there to speak up against the changes, and presumably those went through,” Dr. Radcliffe said. “But when it came to the MIGS proposed changes, there were many, many clinicians from private practice, from academic centers, and even those who had worked with industry who were able to speak on the positive outcomes. I also know that many clinicians wrote letters to politicians, as well as to the Medicare MAC directors, and I think the volume of these letters had a very big impact.” The engagement and advocacy of doctors, the societies, and their patients was incredibly valuable, he said.
Dr. Radcliffe noted the tireless work of ASCRS, AAO, and AGS, particularly highlighting the dedication of Dr. Parekh, Mark Cribben (ASCRS director of government relations), Michael Repka, MD, David Glasser, MD, Dr. Herndon, and Geoffrey Emerick, MD.
“This is a story about the value a society, such as ASCRS, brings back to its members, and ultimately back to the patients.”
About the physicians
Leon Herndon Jr., MD
President, American Glaucoma Society
Past Chair, ASCRS Glaucoma Clinical Committee
Professor of Ophthalmology
Duke University
Durham, North Carolina
Parag Parekh, MD, MPA
ASCRS Government Relations Committee Chair
Dubois, Pennsylvania
Nathan Radcliffe, MD
Chair, ASCRS Glaucoma Clinical Committee
New York Ophthalmology
New York Eye Surgery Center
New York, New York
Relevant disclosures
Herndon: None
Parekh: None
Radcliffe: None
Contact
Herndon: leon.herndon@duke.edu
Parekh: parag2020@gmail.com
Radcliffe: drradcliffe@gmail.com
