The wonderful healing properties of amniotic membranes

	Stephanie Woo, O.D. Photo credit: Steve Craft

Excerpted from page 20 of the July/August 2019 edition of AOA Focus.

Rural and sparse, the Lower Colorado River Valley and Sonoran Desert are unforgiving terrains, pockmarked by the occasional green township in a dusky red landscape. Lake Havasu City, the largest of those oases at 53,000, is where Stephanie Woo, O.D., proudly proclaims she's the only cornea/contact lens residency-trained doctor of optometry for 200 miles. That knowledge is critically bene­ficial for her patients in nearby, out-of-the-way towns, and especially one patient in particular.

Living in one of those rural towns, a woman arrived at Dr. Woo's practice with what could only be described as a strange corneal ulcer—nothing worked on it. Following a negative bacterial culture, Dr. Woo tried antibiotics, antivirals and steroids—even corneal specialists were perplexed. But with limited mobility and transportation, the patient wasn't fit to travel hours to the nearest referral center.

"We really tried everything, and nothing would resolve this weird thing," Dr. Woo recalls. "So we tried something that I hadn't invested a ton in before."

Dr. Woo turned to an amniotic membrane. Within 48 hours, the previously elevated defect had completely flattened, and even the amount of corneal haze and opacification had diminished by almost

80%. The drastic turnaround for something that hadn't even responded to topicals and orals was nothing short of incredible, Dr. Woo recalls. The experience made her a believer in the power of amniotic membranes.

"It's become a gold standard of care in my practice," Dr. Woo says. "Being in a rural area, you have to be ready to treat anything that walks through the door because there are so many patients who cannot leave the community. We have to be armed with the best defenses we have, and part of that is amniotic membranes."

They're nothing new; these slivers of human amniotic tissue have been used for nearly a century in general wound healing. But only in the past decade or so have eye care providers embraced the tissue for its ability to rehabilitate the ocular surface. Amniotic membranes offer a natural, sutureless treatment option to doctors of optometry that's highly effective against the toughest of ocular surface concerns. So what is it about amniotic membranes that impart these superior healing properties?

The basics

It's all in the tissue. The amniotic membrane is the innermost, avascular layer of fetal membranes—composed of the epithelium, basement membrane and stroma—collected from full-term placental tissue and treated with antibiotics during collection. Those layers contain properties that each play an important role in healing. While the basement layer's collagen makeup closely resembles that of the cornea and conjunctiva, thereby promoting cellular growth, the stroma contains the all-important fetal hyaluronic acid and cytokines necessary to reduce inflammation. In other words, amniotic membranes afford anti-inflammatory, anti-angiogenic, anti-microbial and anti-fibrotic properties, Dr. Woo notes.

Additionally, once amniotic membranes are deployed on the ocular surface akin to a bandage contact lens, the tissue assures both physical protection of the wound while also promoting a healing environment, says Nathan Lighthizer, O.D., assistant dean and associate professor at Northeastern State University Oklahoma College of Optometry.

"We've had drops and oral pharmaceuticals, but the ability to put something on the eye that has anti-inflammatory and anti-scarring properties is something that's brand new," Dr. Lighthizer says. "A patient with a large corneal abrasion, you could treat with a bandage contact lens to help with pain, but it won't promote healing in the way that amniotic membranes do."

This raises the question: When is the appropriate time to consider using amniotic membranes? While not a first-line treatment, amniotic membranes should be considered anytime doctors want to promote healing or inhibit inflammation and scarring, Dr. Lighthizer suggests. Those specific conditions might include recurrent corneal erosions; significant or severe dry eye with superficial punctate keratitis or a corneal disturbance that won't go away; neurotrophic ulcers, such as those associated with diabetes or viruses like herpes simplex or herpes zoster; and even chemical or physical burns to the eye.

As for the latter, Dr. Woo can attest firsthand. When a patient presented with 60% of her cornea burned from an unfortunate curling-iron accident, Dr. Woo strongly recommended an amniotic membrane and antibiotics. Only 24 hours later, the giant epithelial defect had resolved by nearly 80%, and by 72 hours, it was completely re-epithelialized.

"That's just unheard of for a bandage contact lens," Dr. Woo says.

The challenges

It would stand to reason that for all their healing properties, amniotic membranes would be widely adopted throughout optometry. But data suggests this modality hasn't caught like wildfire. According to the most recent information from the Centers for Medicare & Medicaid Services (CMS) 2016 Provider Utilization and Payment Data, only 314 doctors of optometry reported the HCPCS code 65778 (amniotic membrane insertion). Recent reports suggest 2017 CMS data might only be a modicum better at around 400, or about 1% of practicing doctors of optometry in the U.S.

In Dr. Woo's opinion, optometry can and should do a better job incorporating amniotic membranes into practice. However, a combination of inherent challenges and a general lack of familiarity with the procedure has kept utilization low.

"A lot of optometrists don't really know this exists," Dr. Woo says. "This was not really discussed when I was in school—and I didn't graduate that long ago—so I know that for the optometrists who graduated even before me, this wasn't something they knew about.

"We need to spread the word about this amazing technology, and we definitely have room to grow."

That's why Drs. Woo and Lighthizer feel so emboldened to lecture on the subject, especially at opportunities like Optometry's Meeting ^®. There again, it's also a chance to address the real-life concerns and challenges that doctors face when considering offering this level of care. While bridging the awareness gap is the first and foremost concern, the next most common challenge is addressing cost.

Amniotic membranes aren't cheap. Moreover, they're a product that naturally doesn't keep for very long. That combination can make it less-than-palatable for many doctors dipping their toes in the water.

Amniotic membranes can cost anywhere from $300 to $900 per device, and that can be a significant problem for patients paying out of pocket. The good news is that most insurance carriers will reimburse with the right indications and CPT code, Dr. Lighthizer says. But, even that was a challenge at first.

Originally, when the American Medical Association issued CPT code 65778 in 2011, it described a "surgical procedure" for the insertion of amniotic membranes. That description inherently caused friction among commercial carriers and doctors of optometry in a few states when payers argued it wasn't within optometry's scope of practice. Hence, in 2014, CPT amended the code descriptor to read "placement of amniotic membrane on the ocular surface; without sutures."

While that confusion is mostly assuaged, given amniotic membranes' high-priced stature, Dr. Woo says it does require calling insurance for prior authorization. Her practice has patients pay out of pocket upfront, then they are reimbursed once cleared by insurance.

"We have had a few issues where insurance hasn't paid or it's not a recognized code through their carrier, but I would say 90% of the time it hasn't been an issue," she says.

The dollars and sense

So do amniotic membranes make sense for your practice? That's the question many doctors of optometry will need to determine in the years ahead. Dr. Lighthizer strongly suggests that any medical eye care or contact lens practice take a good, hard look at how amniotic membranes would manifest in their o­ffice."

If you're managing dry eye—at all—any anterior segment disease, corneal disease, conjunctival issues, or if you have a contact lens practice, you're likely going to have an ocular surface disease practice, e.g., dry eye. If you're fitting contact lenses, then there's strong reason to believe you should have a few amniotic membranes in the o­ffice for managing those abrasions or recurrent corneal erosions or that severe dry eye that may come in," Dr. Lighthizer says.|

Despite the low utilization now, Dr. Lighthizer says he expects amniotic membranes to gain widespread use in the years ahead. That's doubly true as emerging research reimagines the tissue's healing properties in a possible topical eyedrop form. Dr. Lighthizer envisions a future where doctors of optometry might prescribe a drop for patients' continuous use, thereby maximizing its e­fficacy.

"Just being able to offer a patient something that will help heal their eyes—we can prescribe drops and medications—but to be able to put something on the eye that truly has healing properties is powerful," Dr. Lighthizer says.

"Understanding the power of amniotic membranes has really been eye-opening."

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