Jan Beiting

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Surgeons and administrators must weigh myriad factors when considering implementing new technology in a practice, including clinical and financial benefits.

When deciding whether to implement a new surgical technology, surgery centers must consider a range of factors, from clinical and financial benefits to the impact on practice flow and logistics. In one such instance, administrators and surgeons have been evaluating the pros and cons of various approaches to mydriasis during cataract surgery.

-and therefore, an adequate view of the surgical field-throughout the procedure is important in reducing the risk of capsule tear, vitreous loss, iris damage, and other possible surgical complications.

There are challenges as surgeons strive to meet this goal, including an increasing number of patients who are coming to surgery with a history (known or unknown) of systemic medications that contribute to intraoperative floppy iris syndrome (IFIS) and unpredictable dilation.

Topical agents administered preoperatively may be washed out during surgery and become less effective. While many surgeons have found it effective to add drugs such as compounded epinephrine or phenylephrine to the irrigating solution or to deliver them during surgery, these off-label practices came under increased scrutiny in the wake of new standards for ambulatory surgery centers (ASC) in 2009.

Additionally, there has been widespread concern over compounded medications after dozens of patients at Key-Whitman Eye Center in North Texas developed retinal problems and vision loss soon after undergoing cataract surgery with intravitreal injection of a compounded steroid-antibiotic (triamcinolone and moxifloxacin) medication in 2017.

 (Omidria, Omeros) was approved several years ago for continuous intracameral administration during cataract surgery to reduce postoperative pain and to prevent pupillary miosis and has since been shown to reduce the use of pupil expansion devices, decrease intraoperative complications, prevent IFIS, reduce incidence of CME, and shorten surgical time in a number of studies conducted in real-world settings.

Phenylephrine/ketorolac was also shown to reduce the use of medications for treatment of pain associated with cataract surgery, including opioids such as fentanyl.

 Reducing postoperative pain is essential for improving patient satisfaction and minimizing patient callbacks, which can meaningfully impact facility efficiency and productivity.

“With any new technology, we rigorously evaluate whether it is good for patients, good for employees, and good for the surgery center,” said Andrew Gwinnell, executive director, TruVista Surgery Center, Troy, MI.

After a trial of the fixeddose combination, surgeons at TruVista decided the answer to all three questions was “yes,” and made it part of their standard cataract orders for all patients (except those with drug hypersensitivity issues).

“We try to standardize surgery as much as possible,” Gwinnell noted. “So, in addition to safety and efficacy, we have to make sure that a new technology either fits into our existing processes or that those processes can be modified in a reasonable manner to accommodate the new drug or device.”

Surgeons at TruVista Surgery Center had not previously added anything to the irrigating solution but had relied on compounded “epi-Shugarcaine” (buffered lidocaine with epinephrine) given intraoperatively to maintain mydriasis.

“We had heard some reports of stability issues with compounded drugs elsewhere, so the ability to use an FDA-approved drug rather than a compounded product was an important factor in our decision,” Gwinnell pointed out.

Gwinnell also acknowledged that they needed a mydriasis solution that worked for the bottom line as well-something that has become much easier in the wake of the October reinstatement of “pass-through” status for phenylephrine/ketorolac by the Centers for Medicare and Medicaid Services (CMS).

The decision means that surgery centers can once again bill Medicare Part B with confidence that 100% of Medicare administrative contractors (MACs) reimburse separately for the drug, outside of the packaged cataract surgery facility fee (i.e., the ambulatory payment classification). Additionally, a substantial and growing number of Medicare Advantage and commercial payers are reimbursing for phenylephrine/ketorolac.

For Heather Hilgendorf-Cooley, administrator, Spring Park Surgery Center, Davenport, IA, the clinical benefits of phenylephrine/ketorolac made the decision a “no-brainer.” The multispecialty ASC, which offers ophthalmology, urology, and pediatric dentistry services, had previously been using lidocaine/phenylephrine drops and putting 0.3 mL of epinephrine in the infusion bottle 

-a practice they ultimately had decided was not sustainable for an AAAHC-accredited ASC.

Research showing that intracameral phenylephrine-/ketorolac-maintained iris tone and reduced postoperative pain proved to be convincing, as did surgeons’ initial experience with phenylephrine/ketorolac at Spring Park.

“They found that it kept the iris stable and pupils dilated, even during femtosecond laser cases, allowed them to avoid iris sphincter tears due to mechanical manipulation, and improved outcomes and safety,” Hilgendorf-Cooley noted. “We felt so strongly about the added safety that we were willing to take the risk of renegotiating our commercial contracts to include a carve-out, even before they were up for renewal, so that all our patients could benefit from cataract surgery with [phenylephrine/ ketorolac].”

Hilgendorf-Cooley said she believed the financial numbers were still in their favor even during the 9-month period during which Medicare did not reimburse for the intracameral drug as a pass-through.

“You have to weigh the costs of the alternatives against the new technology,” she explained. Hilgendorf-Cooley estimates that the fixeddose combination reduced the center’s use of non-reimbursed Malyugin rings (at about $150/ each) by 32%.

By switching to simple lidocaine numbing drops for most patients instead of the lidophenyl drops, they saved nearly $20 in supply costs per case.

They also cut back on staff time to draw up the medications on every cataract surgery day. During their AAAHC accreditation, Spring Park Surgery Center was able to provide proof that they were only using FDA-approved drugs in the irrigating solution.

Hilgendorf-Cooley further noted that ASCs also need to weigh the intangible benefits of having the latest technology, such as being perceived as cutting edge, generating referrals, or attracting more surgeons to the ASC.

For example, Spring Park acquired its own extracorporeal shock wave lithotripsy (ESWL) machine for its urologists to break up kidney stones-a high-tech device that even some hospitals do not have.

“That kind of technology investment has helped to ensure that we have the largest market share for urology and ophthalmology procedures in the Quad Cities,” Hilgendorf-Cooley concluded.

Patti Barkey, COE, administrator, Bowden Eye and Associates, Jacksonville, FL, agreed that modeling the clinical and financial benefits of new technology can be complex. “We have to consider not just the senior surgeon but whether a new technology will make it easier for younger surgeons to achieve good outcomes,” she said.

Barkey considers implementation of intracameral phenylephrine/ketorolac to be part of the practice’s conscious effort to invest in what matters for its patients.

“We have particularly focused on new technologies that improve patient outcomes or patient satisfaction,” she pointed out. Pain after surgery is a significant factor in patient perceptions of surgery.

More than one-third of cataract surgery patients experience moderate to severe pain in the immediate postoperative period,

and research has shown that postoperative pain ultimately is a leading reason for dissatisfaction with cataract care.

 In clinical studies, patients were more than 50% more likely to be pain-free when the fixeddose combination was used (p=0.0027).

As a result, significantly fewer patients required pain medications, including opioids, on the day of surgery with phenylephrine/ketorolac. Barkey also explained that practices benefit when new technology can offer greater consistency from one case to the next.

“By using [phenylephrine/ketorolac], we have been able to eliminate iris stability issues and better anticipate our surgical flow, which increases efficiency,” she said.

Barkey also noted that she suggests discussing with all surgeons the plan to incorporate phenylephrine/ketorolac as a common standard unless the patient has a contraindication. “The contraindications should always be reviewed prior to the case and at the time-out phase,” she noted.

All three of the practices profiled here are currently exploring new minimally invasive glaucoma surgery (MIGS) procedures.

“In glaucoma care, the efficacy of topical therapies has always been limited by poor compliance in a significant percentage of the patient population,” Barkey explained. “We are looking at MIGS technologies not only in terms of their absolute pressure-lowering ability but also as a way to remove patient compliance from the equation and result in better outcomes.”

When evaluating new technologies, administrators recognize that their first decision is not always the last word. TruVista’s governing board initially rejected acquiring a femtosecond laser for cataract surgery, for example. Two years later, with more clinical evidence and experience, they changed their minds. And even after implementation, they have sometimes reconsidered platform choices.

“You have to implement and then continue to re-evaluate patient and physician satisfaction,” Gwinnell concluded.


	E: agwinnell@truvistasurgerycenter.com
	

Gwinnell has been a paid speaker for Omeros.


	E: hilgendorf-cooleyh@springparksurgery.com
	

Hilgendorf-Cooley is a part of Omero’s administrator speaker panel.

1. Al-Hashimi S, Donaldson K, Davidson R, et al. Medical and surgical management of the small pupil during cataract surgery.

2. Guzek JP, Holm M, et al. Cotter JB, Cameron JA, Rademaker WJ, et al. Risk factors for intraoperative complications in 1000 extracapsular cataract cases. 

3. Lee SM. Blindsided: At least 68 people are nearly blind after a botched drug was injected into their eyeballs. BuzzFeed News, Sept. 21, 2018. Accessed Dec. 19, 2018: https://www.buzzfeednews.com/article/ stephaniemlee/guardian-pharmacy-compoundinglawsuits-cataracts

4. Rosenberg ED, Nattis AS, Alevi D, et al. Visual outcomes, efficacy and surgical complications associated with intracameral phenylephrine 1.0%/ ketorolac 0.3% administered during cataract surgery. 

5. Silverstein SM, Rana VK, Stephens R, et al. Effect of phenylephrine 1.0%-ketorolac 0.3% injection on tamsulosin-associated intraoperative floppy-iris syndrome. 

6. Walter K, Delwadia N. Miosis prevention in femtosecond-assisted cataract surgery using a continuous infusion of phenylephrine and ketorolac. ASCRS 2018.

7. Gayton J. Effect of early phenylephrine and ketorolac injection 1%/0.3% on pupil diameter in traditional and femtosecond-assisted cataract surgery. ASCRS 2018.

8. Matossian C. Clinical outcomes of phenylephrine/ ketorolac (1%/0.3%) versus epinephrine in cataract Surgery in a real-world setting. ASCRS, 2018.

9. Hovanesian JA, Sheppard JD, Trattler WB, et al. Intracameral phenylephrine and ketorolac during cataract surgery to maintain intraoperative mydriasis and reduce postoperative ocular pain: Integrated results from 2 pivotal phase III studies.

10. Porela-Tiihonen S, Kaarniranta K, Kokki H. Postoperative pain after cataract surgery. J Cataract Refract Surg. 2013;39:789-798. 11. Fung D, Cohen MM, Stewart S, Davies A. What determines patient satisfaction with cataract care under topical local anesthesia and monitored sedation in a community hospital setting? 

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