GLAUCOMA IN THE ASC
PART 2 IN A SERIES

Diminishing Returns

ASCs must adapt in the wake of reimbursement cuts for glaucoma procedures

By Desiree Ifft, Contributing Editor

For ASCs with glaucoma procedures in the case mix, the Centers for Medicare and Medicaid Services (CMS) Final Rule for ASC payment for 2016 brought unfortunate changes. Two are direct hits to the bottom line: 1) The Medicare Part B pass-through reimbursement for Mitosol (mitomycin-C, Mobius Therapeutics) has expired, and 2) The National Correct Coding edits were revised such that reimbursement for performing a patch graft (67255) is included in the reimbursement for performing a tube shunt procedure (66180). Therefore, ASCs and surgeons can no longer be separately reimbursed for the patch graft procedure and associated tissue.

“In the second half of 2015, there was a short period of time in which corneal tissue was separately reimbursed by Medicare, but that expired at the end of 2015,” explains Kevin J. Corcoran, COE, CPC, CPMA, FNAO, president of Corcoran Consulting Group. “The 2016 CMS Final Rule is clear: Any tissue used for a patch graft in aqueous shunt surgery (e.g., amniotic membrane, cornea, sclera, pericardium, and so on) is part of the facility fee and not separately reimbursed.” Billing and reimbursement for a tube shunt revision procedure (66185) changed in a similar fashion for this year.

ASCs are convenient and efficient glaucoma surgery venues for doctors and patients, and are cost-effective for the healthcare system, but profit margins are tight. The procedures are complicated and often require a significant amount of physician time for multiple follow-up visits, so no decrease in reimbursement is easy to bear. “Often, if you break even, you’re happy; yet, ASCs are getting squeezed all the time,” says Robert J. Noecker, MD, MBA, a glaucoma specialist with Ophthalmic Consultants of Connecticut. “The sad truth is that it makes surgeons and ASCs question whether these sight-saving procedures should be done in their facilities at all.” Dr. Noecker points out that decreases in physician payment for procedures performed in an ASC could have an indirect effect on ASC volume. For example, the 2015 national Medicare payment to physicians for laser trabeculoplasty (65855) performed in an ASC was $302, but it decreased to $244 in 2016. The same procedure performed in-office is allowed $278. “Surgeons may choose to move trabeculoplasties from an ASC to the office,” says Dr. Noecker.

Back to Compounded Mitomycin-C?

Although the expiration of the pass-through reimbursement for Mitosol was expected, it takes away nearly $400 that ASCs had been reimbursed for its use since 2013. Facilities and surgeons who use Mitosol feel it’s best for patients because it’s the only mitomycin-C (MMC) formulation that is FDA approved specifically for ophthalmic use. The alternative for facilities is to purchase MMC from a compounding pharmacy. It typically costs $20-$40 per case, depending on the region, and, as Corcoran reminds, “Under longstanding CMS regulations, no separate reimbursement is made for compounded medications used in a procedure performed in an ASC.” The cost may not seem like much, but after hundreds of cases, it amounts to tens of thousands of dollars, Dr. Noecker says. He also notes the mixed message whereby “On one hand, FDA mandates on-label MMC for clinical trials; but on the other hand, CMS payment policy discourages its use in the ASC setting.”

Reimbursement aside, the concentration consistency of compounded MMC has been called into question. In one recently published study,1 60 samples of 0.4 mg/mL of MMC were acquired from a spectrum of common compounding and storage techniques and tested. The study authors reported that the mean measured concentration of MMC was significantly lower than the expected 0.4 mg/mL concentration across all samples. In addition, the measured concentration exhibited a range between 0.26 and 0.46 mg/mL. The authors say the clinical relevance of the findings on glaucoma surgery outcomes is not known, but improving the accuracy and variability of compounded MMC concentration may enhance trabeculectomy outcomes.

At Fishkind, Bakewell, & Maltzman Eye Care and Surgery Center in Arizona, they’ve stopped using Mitosol and are instead purchasing compounded MMC as they did prior to Mitosol’s availability. “I liked Mitosol, as I felt there was a degree of consistency to the product, and I had fewer concerns about contamination or improper dilution,” says Jeff Maltzman, MD, FACS. “I anticipate no negative effect on surgical outcomes based on my years of prior experience with compounded product, which we acquire from a trusted in-state pharmacy. However, I will carefully monitor for increases in complications and surgical failures. If I find the compounded drug inferior to Mitosol, I will most likely switch back, despite the added expense, because the safety and efficacy of the procedure must trump cost.”

It’s best to deal with a trusted vendor of compounded MMC or self-compound it, Dr. Noecker says. “But the realities are that some compounding pharmacies are great and others are marginal, and tightening regulation of on-site compounding is taking away the self-compounding option. Also, surgeons who operate in ASCs they don’t own could be in a situation in which they’re unaware that ASC staff decided to source MMC from a different vendor, so they don’t know what they might get.”

Dr. Noecker says he’ll continue to use Mitosol in cases where the risk of not using it is unacceptable, but would prefer not to have to add the variable of compounded MMC to any case. “It’s a true concern,” he says. “If the formulation isn’t potent enough, we may have scarring and a failed surgery. If it’s too potent, we have the risks of leaking, melting, and infection. Importantly, too, as glaucoma surgeons, we quibble about and debate the best concentration to use and the best exposure time. We’re trying to figure these things out, but it all goes right out the door when you can’t control what you think you’re controlling.”

Although it may be difficult to know how many ASCs will continue to use Mitosol in the long term, Mobius Therapeutics President and CEO Ed Timm says the company had retained more than 90% of its Mitosol sales volume at the end of the first quarter. “We’re viewing the end of pass-through payment as an opportunity,” he says. “When you have reimbursement in place from the federal government, it more or less sets your selling price. One size fits all. With reimbursement out of the picture, we’re a cash product and can treat our customers in a manner that’s more market-driven. That means a lower average selling price, but we’ve never sold our product solely based on price. There are dramatic differences between Mitosol and compounded MMC.”

Timm cites the differences as including that Mitosol has the same potency in every pack; requires no refrigeration or shielding, yet has a shelf life of 24 months; is reconstituted on the sterile field at the time of use so degradation isn’t a problem; and is contained all the way through use, which avoids atmospheric exposure to the toxins. “Basically, we solved all of the problems associated with the MMC products that were previously available,” he says. “In this industry, especially in the era of the Affordable Care Act where outcomes will be the foundation of the payment system, products have to provide some manner of improved patient care or they’ll fail. Mitosol does that. It also complies with FDA standards, U.S. Pharmacopeia Convention (USP) standards, and even pending USP standards.”

Loss of Patch Graft Reimbursement

In response to the loss of separate reimbursement for tissue used as a patch graft with tube shunt surgery, Nathan Radcliffe, MD, has been using a corneal or pericardial patch graft, as he had been doing prior to 2015, or using no graft at all. “I’m sorry to say it has been the insurance that’s primarily making that determination,” he says. He notes one exception: “If I re-operate on an eye that has had some sort of exposure or a breakdown of a pericardial patch graft, I use donor cornea whether it’s reimbursed or not.”

Dr. Radcliffe, who is director of the Glaucoma Service and clinical assistant professor at New York University Langone Ophthalmology Associates, also operates at the Ambulatory Surgery Center of Greater New York. Corneal grafts are still reimbursed at the hospital, but at the ASC, his team has determined each insurance plan’s patch graft reimbursement policy.

“If they reimburse for cornea, that’s my first choice,” he says. “If they reimburse for pericardium, I use that. And in Medicaid patients for whom no patch graft is reimbursed, I’ve been making a very long scleral tunnel. The technique is more time-consuming and more technically demanding, but I believe it provides a safe and effective way of eliminating erosion, although given that there were no downsides to placing a patch graft, I would still like to have that option available for every patient. So far, patients have done well with no graft and a longer tunnel, and I’m proceeding with that approach.”

Dr. Radcliffe explains there are several ways to create longer scleral tunnels. One is to create a scleral flap approximately 3 mm from the limbus and tunnel through the base of the flap. Another approach is to simply bend the 23-gauge needle and push for longer and longer, using a shallow angle of approach, with each case. “I began making longer tunnels several years ago, even while I was still using patch grafts in every case, in anticipation of the day when I would have to stop. When the day finally came, I had been routinely making 5- and 6-mm long tunnels, and I was ready.”

At Dr. Maltzman’s ASC, where the current volume of tube shunt surgeries is low, they’re continuing to discuss the patch graft issue. He’s considering changing his technique to a long scleral tunnel to avoid the use of a graft, but he’s concerned it could raise the risk of infection and lead to a higher rate of tube erosions. “We could, most likely, absorb the graft cost if our shunt volume were to remain low,” he says. “However, it would be untenable if volume increases. Should that happen, we may no longer be able to perform shunt procedures requiring grafts in our facility.”

Although it would be understandable if surgeons moved their glaucoma surgeries from ASCs to hospital ORs, a bigger problem, as Dr. Noecker sees it, would be if they decided to stop performing them altogether. “We could end up with tube surgeries being clustered in only a few centers,” he says. “It may become difficult to find local surgeons to serve these high-risk patients, which would force them to travel long distances. Glaucoma is what I’ve chosen to do, so I have to take the good with the bad. But others may decide to not even start doing these surgeries.”

“There is, unfortunately, no perfect solution at this time, and I believe that we and our advocacy organizations should continue to push Congress and CMS to reimburse the use of patch grafts,” Dr. Maltzman says. “We must advocate for what is best for our patients.”

Take Advantage of Good News

In assessing the overall current climate in reimbursement for glaucoma surgery in the ASC, Dr. Radcliffe describes it as a time of fairly rapid changes for surgeons and facilities. “But the good news is that we’re in an era now where we have many more treatment options, including safe options for combined cataract and glaucoma surgery,” he says. “It’s a time to carefully assess not only your reimbursements but also the mix of procedures you’re doing.” He notes that there are now multiple procedures capable of achieving the same anatomical result, which is to open Schlemm’s canal to relieve resistance at the level of the trabecular meshwork and lower intraocular pressure. “However,” he continues, “each of them, for example, iStent (Glaukos), Visco360 and Trab360 (Sight Sciences), the Kahook Dual Blade (New World Medical), and ab interno canaloplasty (ABiC, Ellex), has a different business model, if you will. One is an implant, three are single-use disposables, and one is a machine along with a disposable microcatheter. The options allow for versatility, and some may work better for one practice versus another. Some options may benefit the ASC more than the doctor. Everyone has to look at their individual situations, and doctors and ASCs should work together to determine which treatments they are most comfortable providing.”

The goal is to utilize the newer treatment options, which are designed to treat mild to moderate glaucoma, to stop the progression of the disease, and reduce the number of tube shunt and trabeculectomy procedures, Dr. Radcliffe says. More help with that may be on the way. Now in development are drug-eluting implants for sustained delivery of IOP-lowering medications to the eye. Such a treatment has the potential to better control IOP, transforming the reimbursement landscape as anti-VEGF injections did in retina care. In the meantime, Dr. Radcliffe recommends glaucoma surgeons “adapt to the changing environment by being dynamic in the ASC in terms of the procedures being offered.” ■

Reference

	Jeff Maltzman, MD, FACS, specializes in cataract surgery and the medical and surgical management of glaucoma with Fishkind, Bakewell & Maltzman Eye Care and Surgery Center in Arizona.
	Robert J. Noecker, MD, MBA, is a glaucoma specialist with Ophthalmic Consultants of Connecticut.
	Nathan Radcliffe, MD, is director of the Glaucoma Service and clinical assistant professor at New York University Langone Ophthalmology Associates. He also operates at the Ambulatory Surgery Center of Greater New York.