Use of, and Medicare Expenditure on, Sutureless Amniotic Membrane Grafts Soared — and Maybe Not for a Good Reason

Despite questionable evidence about their benefit for some conditions, including dry eye disease, use of sutureless ocular amniotic membrane grafts soared from 2011 to 2020, according to research findings reported in the journal Ophthalmology. As a result, the cost of the claims submitted to traditional fee-for-service Medicare for the grafts jumped nearly 30-fold, from $3.6 million in 2011 to $95.6 million in 2020.

The researchers who conducted the study said that Medicare reimbursement for the grafts fueled the surge in use and associated Medicare spending because it reimbursed ophthalmologists and optometrists the wholesale acquisition cost (WAC) price for the grafts instead of what they actually paid the manufacturers. That difference, which can be as much as $600, meant a profit margin for sutureless ocular amniotic membrane grafts that in some cases exceeded what eye specialists could charge for routine cataract surgery, according to first author Daniel Vail, M.D., of the Shiley Eye Institute of the University of California, San Diego. R

Referencing an inspector general’s report, Vail and his colleagues said that many manufacturers have ignored rules requiring them to report their actual sales price instead of the WAC price, which for devices (and drugs) is just a starting point before various discounts are applied to boost sales.

“By more closely aligning tissue reimbursement with true acquisition costs for sutureless AMGs [amniotic membrane grafts], policymakers could ensure continued coverage for a medical device with established benefits and encourage ongoing research into its adoption for novel clinical indications, while also limiting the costs associated with inappropriate use of AMGs in situations where they are unlikely to benefit patients,” Vail and his colleagues wrote in the conclusion section of their study, which was published in August 2025 as an article in press.

Ushering in the sutureless era

Amniotic membrane grafts are made from the innermost layer of the placenta, or amnion. According to the American Academy of Ophthalmology, the membrane consists of a thick basement membrane and an avascular stromal matrix, and the thinking is that the basement membrane has healing powers for certain eye conditions because the basement membrane is similar to the conjunctiva. In a thumbnail history in the introductory section of the Ophthalmology paper, Vail and his co-authors say that amniotic membrane grafts have been used in ophthalmology since the 1940s and that the use increased in the 1990s after better ways of preserving the tissue were developed. Then, in 2003, the FDA approved ProKera, which in appearance resembles a large contact lens and consists of a plastic ring that holds the amniotic membrane. Prokera ushered in the era of amniotic membrane grafts that can be placed in the eye with relative ease without sutures or glue.

In Vail and his co-authors’ opinion, amniotic membrane grafts have proven clinical benefits for severe vision-threatening conditions such as Stevens-Johnson syndrome and severe burns. Their use for other indications is controversial, they say. For example, Vail and his colleagues say that some studies have found only “modest potential benefit” for their use as a treatment for bacterial keratitis and others found no clinical benefit for recurrent pterygia and some chemical burns.

But it is the use of sutureless amniotic membrane grafts as treatment for dry eye disease that has really taken off. Vail and his colleagues characterize their use as a treatment for dry eye disease as “an area of ongoing research and controversy.”

Vail and his colleagues used a 20% sample of Medicare Part B fee-for-service claims to conduct their study. They started with the claims filed for 2021, the year that the common procedural terminology code for “placement of amniotic membrane on the ocular surface without sutures” was approved, and ended in 2020, which they said was the last year that CMS data was available to them. They found 49,180 instances of the billing code for sutureless amniotic membrane grafts in that period and 23,984 unique patients.

In their sample the frequency of the grafts soared from just 319 in 2011 to 8,031 in 2020. Claims were submitted by 6,416 providers, and Vail and his colleagues found that 64 (1%) of providers accounted for 28.2% of the claims.

Vail and his colleagues also shared data showing the skyrocketing use of sutureless amniotic membrane grafts for dry eye disease. In 2011, almost 40% of the claims for the grafts were for treatment of corneal ulcers, and just 7.2% were for dry eye disease. By 2020, dry treatment accounted for 44% of the claims for the grafts.

The researchers also looked for differences between optometrists and ophthalmologists in the claims data. Uptake by optometrists was slow to start, they said, but by 2020, optometrists generated 43.3% of the claims. After factoring in age, diagnosis, sex, and comorbidities, they found that patients that were seen by an optometrist were more likely to get a sutureless amniotic membrane graft than those seen by an ophthalmologist. They also found that patients were likely to be treated with a sutureless graft within a week of meeting a provider if that provider was an optometrist.

Extrapolating the results

Vail and his co-authors extrapolated from their 20% sample to arrive at estimates of Medicare spending on the sutureless grafts. In addition to the jump from $3.6 million in 2011 to $95.6 million in 2020, they found that the allowed charges went from $1.4 million to $53.4 million. They note that those amounts are just part of what Medicare paid for the sutureless grafts because they don’t include people enrolled in Medicare Advantage plans.

Vail and his colleagues reference an inspector general’s report and a New York Times investigative story that found “pervasive clinically inappropriate use” of skin substitutes for wound care. “The use of amniotic membrane grafts in ophthalmology has not received similar attention despite relying on a similar reimbursement model,” they note. Vail and his colleagues say that the spread between the price that clinicians pay for the sutureless grafts and their reimbursement by the CMS means that clinicians are, in effect, being paid a commission by the sutureless graft suppliers.

“In an environment where the physician fee schedule has failed to keep pace with inflation, and where eye care has repeatedly been targeted with fee cuts, it is in clinicians’ best interest that policymakers reduce spending by targeting wasteful and inefficient care, rather than by implementing broad cuts in the fee schedule,” wrote Vail and his colleagues.