Commercialized by ImprimisRx in 2014, “drop-free” cataract surgery—or surgery with fewer postoperative medications—has some clear potential benefits, particularly for an older population that faces a range of compliance challenges. Several recent FDA-approved developments in drug delivery technology have helped make it possible. Dextenza (Ocular Therapeutix) is a 0.4mg dexamethasone intracanalicular insert placed in the punctum that offers 30 days of steroid coverage. Dexycu (EyePoint Pharmaceuticals) is a single 9% dexamethasone injection given at the end of cataract surgery, also lasting 30 days. Finally, Omidria (Omeros) is 1% phenylephrine and 0.3% ketorolac, added to irrigating solution during surgery to immediately start the NSAID effect, which includes preventing miosis and reducing inflammation and pain.
In talking to several surgeons who perform drop-free cataract surgery, it was clear that the approach has benefited not only patients who would have required three eye drops, but also the practice’s workflow, which now sees fewer interruptions. Read on for the surgeons’ takes on pass-through reimbursement for drop-free products, as well as their thoughts on where sustained-release and other delivery options are headed in the future.
Why Drop-Free Cataract Surgery?
Topical medications lend themselves to poor compliance. It takes dexterity and steady hands to instill eye drops—two things that diminish with age. For the complex schedule of a three-medication postoperative routine, which will overlap if the fellow eye is done two weeks later, patients also need clear organization. All the physical and mental problems associated with aging make organizing a three-drop regimen challenging for many patients having cataract surgery. Using several eye drops on different schedules is also very inconvenient and disruptive to people’s daily lives. And it’s uncommon for a family member to have the time and proximity to help with eye drops several times a day.
All of these challenges can contribute to poor compliance. Thus, surgeons say it is well worth the small effort to give patients at least one fewer postoperative drop.
“Concerns about costs, convenience, compliance, and increasing patient expectations have sparked recent industry innovation in drug delivery options,” says Alice T. Epitropoulos, MD, FACS, of The Eye Center in Columbus, Ohio, and The Ohio State University. “I’m encouraged by the expansion of drop-free surgery and medications that require less-frequent dosing, both of which are beneficial for patients where compliance or physical limitations interfere with their ability to instill eye drops.”
Patients who don’t use their drops as ordered risk infection, inflammation, and other complications. “There is nothing more frustrating than patients who have a good surgical procedure but return a month later with sub-optimal vision because they used medications incorrectly or not at all. Yet it’s very common,” says Eric D. Donnenfeld, MD, FAAO, of the Ophthalmic Consultants of Long Island in Garden City, NY, and New York University Medical Center. “Patients often find it easy to manage two drops, but when we add a third, they start complaining that it’s too complicated, which tells me they’re probably no longer taking their medications correctly. A drug delivery system puts control of postoperative medications into the surgeon’s hands, so we can remove compliance from the equation.”
Cynthia Matossian, MD, FACS, of Matossian Eye Associates, which has multiple locations throughout Pennsylvania and New Jersey, uses Dextenza or Dexycu for eligible patients to eliminate steroid drops, which she says are the toughest ones for patients to use properly.
“Even the sharpest minds can have trouble following a tapering protocol with a steroid for 30 days in one eye, and then starting the tapering schedule on the fellow eye after two weeks can lead to compliance errors,” she explains. After surgery, her patients only need to use an NSAID and an antibiotic, which they find more manageable.
It helps patients accommodate the costs of their drugs as well. “The cost of a steroid, an NSAID, and an antibiotic could total several hundred dollars, depending on the patient’s insurance and copay plans. The quoted price at the pharmacy often causes ‘sticker shock’ for our patients, which in turn results in increased calls to our office for preapproval or requests for generic alternatives. Drop-free surgery changes that dynamic.”
Which Patients Should Go Drop-Free?
Across the board, these surgeons are applying the strategy very broadly. For example, Dr. Donnenfeld uses Dexycu and Dextenza for all eligible patients and sometimes incorporates Omidria as well for patients who qualify for pass-through. “No one turns it down,” he says. “It saves patients the cost of medication and gives them round-the-clock coverage. They appreciate that I offer it to them and really perceive it as an added value as well as good medicine. Now patients actually come in asking for drop-free surgery because they heard about if from friends.”
Dr. Matossian also appreciates the clinical advantages of incorporating Omidria into surgery.
“When we add Omidria to the irrigation solution, it is continuously infused through the phaco and I/A handpieces throughout the entire procedure,” she explains. “With the eye bathed in an NSAID from the start of surgery until the very end, the inflammatory cycle is suppressed from the get-go. Then we deliver a steroid via an insert or injection to continue the fight against inflammation. The eyes are super quiet postoperatively, and I have not needed to use rescue topical steroids in uneventful cataract procedures.”
How Do Pass-Through Payments Work?
Drop-free cataract surgery products are recognized by CMS with pass-through payment status, a transitional characterization granted to newly FDA-approved medical advances to promote innovation. The fee set by CMS generally includes a 6% markup over average sales price. The pass-through payment status usually lasts 3 years, after which reimbursement follows market norms.
As a result of this program, CMS contributes to medical innovation, Medicare patients get the latest treatments at little or no cost, and physicians get greater freedom in choosing treatments with reliable reimbursement.
“CMS sets aside a certain percentage of spending to encourage companies to pursue innovation in therapeutics and diagnostics. They arrive at a price through a complex algorithm, and once pass-through is complete, the price can be adjusted based on market trends,” Dr. Matossian says. “The physician is not responsible for any of the costs, nor is the ASC. What’s more, the manufacturers have reimbursement specialist teams that partner with practices to train the physicians, the surgical coordinators, and the surgery center billing staff. The goal is to help everyone understand who is covered and how to bill, so billing errors are minimized.”
“Omidria paved the way for cataract surgeons and facilities to use technologies with pass-through status and receive reliable reimbursement,” says Dr. Epitropoulos. “These reimbursements were initially pretty controversial, but with Omidria, we got an additional fee of more than $400 added onto the facility fee to cover the costs. Now, we can use any of the three FDA-approved options with no added cost to the practice. With pass-through status, we have confidence that these technologies will be reliably reimbursed for patients with Medicare Part B. Patients are responsible for a 20% copay just as they are for cataract surgery, but Medicare Part B supplemental plans help pick up that 20%. And each of the pass-through products has a permanent unique J code for billing to any payer.”
According to Dr. Epitropoulos, pass-through payment has no effect on her practice’s experiences with CMS’ Merit-based Incentive Payment System (MIPS). This quality-based program applies to Medicare Part B patients only, not those who have Medicare Advantage or commercial insurance.
“MIPS is a system for value-based reimbursement under the Quality Payment Program with the goal of promoting the ongoing improvement and innovation to clinical activities. So if we focus on providing quality outcomes for patients, which represents 45% of a MIPS score this year, then our MIPS scores may actually be better. Drop-free cataract surgery can improve outcomes by removing some compliance risks, and that means higher MIPS scores,” she explains. “It’s also important to keep in mind that there are more than 1,500 diagnostic codes (ICD-10) that exclude patients from inclusion in the MIPS calculation based on CMS criteria, which means MIPS is only applied to a very small number of our patients having cataract surgery. Just be sure to focus on proper coding for clinical comorbidities, which will document the MIPS exclusions.”
Is the Future Drop-Free?
Asked to weigh in on the future of drop-free cataract surgery, surgeons pointed to next-level drop-free surgery already happening in Europe, as well as studies underway in the United States.
“Drop-free surgery is good for the surgery center, the doctor, and—most importantly—the patient. At the end of the day, this is where post-op therapy for cataract surgery is moving,” says Dr. Donnenfeld. “The transition to drop-free surgery is already well underway in Europe, and I think that in the near future we will join them embracing drug delivery systems for a variety of purposes, including cataract surgery. Advanced drug delivery will eliminate the need for topical drops. It will allow us to move to a single standard of care for all patients, where we have control over postoperative recovery and no longer need to evaluate a patient’s ability to use eye drops as ordered.”
“Ultimately, drop-free surgery is our aim and I certainly see more options to support it coming soon,” adds Dr. Matossian. “We’re not fully drop-free postoperatively, but we’ve taken big steps in that direction. We already have two FDA-approved steroids and an FDA-approved NSAID for use at surgery; an intracameral antibiotic is currently being studied. We may see different NSAID delivery systems enter the market and have an FDA-approved antibiotic for use at the end of surgery, as is done in Europe. If we could use a steroid, an antibiotic and an NSAID during or at the conclusion of surgery, then surgery could become truly drop-free. We can count on that happening.” ■