2015 brings big Medicare changes, small technology changes to glaucoma surgery

By Laird Harrison; Reviewed by Cynthia Mattox, MD

The year 2015 brought a trickle of innovation to the technique of glaucoma surgery, and a tidal wave of change to the business model in the United States.

A proposal by the Centers for Medicare and Medicaid Services (CMS) to cut Medicare reimbursement for trabeculectomy of about 30% will hit surgeons in the bottom line, said Cynthia Mattox, MD, a member of the Health Policy committee of the American Academy of Ophthalmology (AAO) and vice president of the American Glaucoma Society (AGS).

The cut came on the heels of a similar reduction in reimbursement for aqueous shunt procedures.  As part of its routine review of reimbursement schedules, CMS announced in November 2014 that glaucoma surgeons could no longer bill separately for patch grafts and aqueous shunts. Combining the two into one effectively slashes reimbursement for these two procedures by 25% to 30%.

Codes reviewed

The change affected Current Procedural Terminology (CPT) codes 66179, 66180, 66184, and 66185 in 2015.

When the codes came up for review, CMS discovered that surgeons typically bill for the two procedures together and ruled that they were really one procedure. (Some surgeons place aqueous shunts without grafts, and now can use code 66179 for an aqueous shunt without patch graft or 66184 for an aqueous revision without a patch graft.)

In the meantime, CMS announced in November 2015 that it is planning to close a temporary loophole that allowed facilities to maintain their 2014 level of reimbursement by invoicing separately for cornea tissue used as patch grafts. The loophole was brokered by the AGS and AAO.

The cut may force many surgeons in 2016 to do their shunt procedures in hospitals where facility reimbursements are higher and more easily cover the costs of all the bundled supplies rather than in ambulatory surgery centers. If very many make that change, CMS will end up paying more than if it had not made the cut, said Dr. Mattox, and patients will face higher co-payments and may have access problems.

Also in November, CMS announced that it was applying its budgetary axe to trabeculectomy. The Relative Value Scale Update Committee (RUC) had not reviewed trabeculectomy reimbursement for many years, and determined that surgeons have trimmed about 15 minutes off of intraoperative time.

CMS has issued the final rule cutting reimbursement by 19% for each trabeculectomy code in 2016, In 2017 the cuts would reach a total of 25% for code 66170, 30% for code 66172 and 35% for code 65855.

The procedures are the bread and butter of glaucoma surgery, Dr Mattox said. “We’re talking about what we do for the most severe cases who present to specialists. IThese procedures are almost always performed in patients who have no other choice. If we don’t do something they will go blind.”

The cuts could spur some surgeons to retire early and deter others from entering the field, creating a shortage of specialists able to do this work, Dr Mattox warns.

She and along with members of the AGS and AAO are continuing to resist. They plan to argue that CMS ignored the recommendation of the RUC, which is tasked with determining reasonable reimbursement for medical procedures. The RUC advised a 7% cut.

But CMS has the final word, and it is faced with a mandate from Congress to trim its total outlay forphysician reimbursements for each year in 2016, 2017 and 2018 while increasing reimbursement for primary care. “Other specialties besides ophthalmology, such as cardiology and radiology have been hit pretty hard in the last few years and they have not been successful in reversing these types of cuts,” Dr Mattox said.

Micro-invasive glaucoma surgery

In the shadows cast by these financial storm clouds, it’s easy to overlook the technological improvements that inched forward in 2015, including micro-invasive glaucoma surgery (MIGS) devices, CO2-assisted laser sclerectomy, pattern-scanning laser trabeculectomy and other new laser systems. “I think that are a lot of things out there that people are waiting to hear about,” said Richard K. Parrish, II, MD, chairman of ophthalmology at the Bascom Palmer Eye Institute, University of Miami Miller School of Medicine.

Multiple MIGS stents chartered milestones in 2015. Among them:

·       A study published in November showed that two of Glaukos’ iStent stents could produce sustained reductions in intraocular pressure (IOP) of less than 15 mmHg through 36 months. And a study presented in June showed that implanting two of the stents at one time could achieve results comparable to travoprost, allowing some patients to stop medication altogether. The iStent was approved in the United States in 2012.

·       In April AqueSys announced that its Xen gelatin stent effectively lowers IOP in patients whose collector systems cannot be used. The Xen is approved in Europe but not in the United States. IN September, Allergan announced t would acquire AqueSys for $300 million

·       In November, InnFocus announced that it is was expanding a trial that compares its MicroShunt to trabeculectomy for the treatment of early, moderate and late stage primary open angle glaucoma (POAG).

·       In April, Ivantis announced that it had completed enrollment for a pivotal trial of is Hydrus Microstent.

·       In October, Transcend announced that it had filed a premarket approval application with the FDA for its CyPass microstent, and in November it settled patent litigation with Glaukos.

Laser advances

Laser surgery also took steps forward in 2015. In October, a small study showed that CO₂ laser-assisted sclerectomy surgery was safe and effective for reducing elevated IOP and medication burden in both primary open-angle glaucoma and secondary capsulary glaucoma. For the procedure, the laser gradually ablates deep scleral layers within the scleral bed, continuing until percolating aqueous humor is visible.

Selective laser trabeculoplasty also advanced in 2015 with the addition of computer guidance. In March, researchers reported that they had used pattern scanning to assure complete treatment without overlap or gaps. They found that the technique was equally effective in lowering IOP, but that patients found it more comfortable.

The next few years look promising for these surgical techniques – as long as glaucoma surgeons can stay in business to provide them.

On the horizon

Many of the techniques surgeons now use look crude compared to the ones that researchers are dreaming up. In 2015, investigators reported promising experiments in mice using stem cells, said Joel Schuman, MD, chairman of ophthalmology at the University of Pittsburgh.

 “The findings are really positive,” he said. “You can take stem cells from a patient. You can transform them so they are trabecular meshwork cells and inject them into the eye, and in mice they home to the trabecular meshwork. They set up house, rebuild the trabecular meshwork and restore function.”

Elsewhere, researchers reported exciting work in optic nerve regeneration, he said. “In mice they’re able to get a portion of the optic nerve to regrow.”

What works in mice doesn’t always work in humans, he cautions. Still “it’s a big advance from where we were 5 years ago.”

Cynthia Mattox, MD

E: cmattox@tuftsmedicalcenter.org

Cynthia Mattox reported research support from Allergan and Transcend.

Joel Schuman, MD

E: schumanis@upmc.edu

Dr. Schuman did not indicate any financial interest relevant to the subject matter.