At Press Time

Warning on “cloned” claims documents; a new use for “rejected” donor corneas; NEI contest seeks eyecare ideas; Membrane removal and DMEK graft adhesion; and more

At Press Time

Warning on ‘Cloned’ Claims Documents

Copying from previous claims can result in denied payment.

■ National Government Services (NGS), a major Medicare administrative contractor serving approximately 23 million people in 18 states and five US territories, is warning practitioners who use electronic health records that claims submitted using documentation copied directly from previous claims will be denied payment. These are called “cloned” claims and do not meet the standard that all documentation must be original, current and patient-specific. Other Medicare contractors are also issuing similar cautionary advice.

In its warning letter, NGS notes that today’s Medicare providers are confronted with the challenges of providing quality healthcare while meeting ever-increasing regulatory and compliance regulations. NGS recognizes that many providers are investing in electronic health records “to increase the quality of their documentation, decrease or minimize documentation time and improve their overall record-keeping capabilities.”

However, NGS cautions that providers need to be aware that electronic health records “can inadvertently cause some documentation pitfalls such as making the documentation appear cloned.” Cloned documentation could cause payment to be denied in the event of a medical review audit of records.


“Documentation is considered cloned when it is worded exactly like or similar to previous entries,” asserts NGS. “It can also occur when the documentation is exactly the same from patient to patient.”

Individualized patient notes for each patient encounter are required. Documentation must reflect the patient condition necessitating treatment, the treatment rendered and if applicable the overall progress of the patient to demonstrate medical necessity.

An electronic health record often allows the providers to utilize default options.

“Defaulted documentation may cause a provider to overlook significant new findings that may result in safety/quality issues,” says NGS. “Default data may document a more extensive history and physical exam than is medically necessary and does not differentiate new findings or changes in a patient’s condition.”

Whether the documentation was the result of an electronic health record, or the use of a pre-printed template, or handwritten documentation, NGS will consider cloned documentation misrepresentation of the medical necessity requirement for coverage of services due to the lack of specific individual information for each unique patient.

“Identification of this type of documentation will lead to denial of services for lack of medical necessity and the recoupment of all overpayments made,” concludes NGS.

In the News …

B+L partners with eye-care incubator. Bausch + Lomb announced a new research partnership with Cirle Inc., a medical technology incubator based in Miami. The partnership brings together leading eye health experts and medical researchers and Bausch + Lomb’s global business and commercial capabilities. As a result, B+L says the two organizations will be better positioned to explore novel, early-stage technologies and develop them into breakthrough innovations that fill previously unmet needs. Included in the partnership will be the technology licensing arm of Bascom Palmer Eye Institute.

“The faculty at Bascom Palmer relentlessly pursues life-changing therapies. This partnership is a testimonial to the value of partnering between best-in-class organizations, including Bascom Palmer and Bausch + Lomb,” said Jack Lord, MD, COO and vice president for medical administration at the University of Miami Miller School of Medicine.

■ Cataract risk from cystic fibrosis drug. The FDA is notifying healthcare professionals, parents/caregivers, and patients in the cystic fibrosis community about a potential safety concern for cataract development in children with cystic fibrosis taking the medication Kalydeco (ivacaftor). This potential safety concern is based on recent results from an animal study that was conducted to support the treatment of young children younger than 2 years old with ivacaftor.

A New Use for ‘Rejected’ Donor Corneas

Unsuited for transplant, they can serve as patch grafts.

■ Donor corneas that are not suitable for cornea transplants may be a better option for patients needing tissue to cover a glaucoma shunt than the traditional tissue used in such operations, according to new research from the University of Alabama, Birmingham (UAB). The findings, published in the Journal of Glaucoma, suggest that cornea tissue is more durable and potentially safer than the more commonly used pericardium grafts.

A commonly used material for such “patch grafts” is pericardium, tissue from the sac that surrounds the heart and is routinely obtained from deceased human donors by tissue banks. The UAB team studied cornea tissue obtained from eye banks. In patients undergoing tube implantation for the first time, the cornea grafts were less likely to thin or erode over time than grafts from pericardium, leaving patients at lower risk for infection or subsequent reparative surgery.

“This is the first study to directly compare glycerol-preserved corneal tissue to another patch graft material in glaucoma shunt surgery,” says Christopher A. Girkin, MD, chair of the department of ophthalmology at UAB and senior author of the study. “It demonstrates that corneal tissue is more effective than pericardium in preventing tube erosion and may also delay the time to erosion.

Additionally, it provides a superior cosmetic result than other available materials.”

The corneas were preserved in glycerol, which confers long shelf life at room temperature, by Global Sight Network (GSN), based in Birmingham, a service of the Alabama Eye Bank. GSN is a non-profit consortium of 33 US eye banks that preserve in glycerol medically eligible corneas not meeting criteria for optical keratoplasty for distribution to qualified facilities worldwide. The UAB Department of Ophthalmology has worked with the Alabama Eye Bank for the past three years to develop and improve the use of glycerol-preserved corneas in glaucoma surgery to enhance the care of advanced glaucoma patients.

“Some of the corneas donated to eye banks for transplant into patients with cornea disease are not optically clear enough and thus are unsuited for that task,” says Christine Curcio, PhD, professor of ophthalmology at UAB and director of the Global Sight Network. “However, this research indicates that they are suited for use as patch grafts for glaucoma patients, providing for very efficient utilization of this valuable tissue resource.”

In the News …

LenSx gets new approval. Alcon said the FDA has cleared the additional indication of corneal flap creation for the LenSx laser. The new approval allows the LenSx technology to be used for corneal flap creation in refractive procedures.

Cystaran approved for cystinosis. Sigma-Tau Pharmaceuticals has received approval from the FDA for Cystaran (cysteamine ophthalmic solution) 0.44%, a topical ophthalmic therapeutic, developed in partnership with the National Institutes of Health for the treatment of patients suffering from corneal cystine crystal accumulation as a result of cystinosis. Cystaran is designated an orphan drug in the United States, and has been granted seven years of market exclusivity.

Sigma-Tau says that topical Cystaran represents an advance over generic cysteamine, a cystine-depleting agent that lowers the cystine content of cells in patients with cystinosis. However, when orally administered, cysteamine does not reach the cornea and is therefore ineffective in reducing the ocular effects of cystinosis. As a result, Cystaran now represents the only FDA-approved ophthalmic treatment for this condition.

Cystinosis is a rare genetic disease that can damage the kidneys and eyes. The initial symptom of ocular cystinosis is photophobia.

■ AMO partners on new IOL materials. Abbott Medical Optics (AMO) and ShapeTech, a research company established by three faculty members from the departments of Ophthalmology and Bioengineering at the University of Colorado, have entered into an exclusive collaboration to jointly develop new polymers for IOLs used in cataract surgery. AMO will work together with ShapeTech to innovate new materials for IOLs that may provide additional benefits for cataract patients and their physicians. ShapeTech LLC was founded by Malik Kahook MD, Naresh Mandava, MD, and Robin Shandas, PhD.

NEI Contest Seeks Ideas on Eye Care

NEI will award prizes for new research concepts.

■ The National Eye Institute’s “Challenge to Identify Audacious Goals in Vision Research” seeks to solicit bold ideas from physicians, scientists, academia, industry and the non-profit sector that will significantly impact the NEI mission to develop treatments and cures for eye disease.

NEI plans to award up to 20 winning contestants $3,000 each and a trip to Bethesda, MD, to present their ideas at the NEI Audacious Goals Development Meeting in February 2013. This meeting will serve to help NEI integrate these ideas into a national research agenda.

The Audacious Goals Challenge seeks ideas that support the NEI mission — to conduct and support research and other programs aimed at reducing the burden of vision disorders and disease worldwide. NEI encourages submissions from people in the private, government, and nonprofit sectors, including scientists, engineers, healthcare providers, inventors and entrepreneurs, as well as the general public.

“Opportunities for scientific progress have never been greater, making strategic planning more critical,” says NEI Director Paul A. Sieving, MD, PhD. “By casting the widest net possible, the Audacious Goals Challenge will enhance our strategic planning with perspectives from people who have not traditionally been a part of the NEI planning process. Output from the challenge will help set priorities and coordinate research efforts.”

Challenge contestants should consult Vision Research: Needs, Gaps, and Opportunities, NEI’s most recent compilation of panel reports that describes progress, current needs and opportunities in six program areas: retinal diseases; corneal diseases; lens and cataract; glaucoma and optic neuropathies; strabismus, amblyopia, and visual processing; and low vision and blindness rehabilitation. The panel reports, issued every five to seven years, represent the work of hundreds of scientists, clinicians and stakeholders involved in vision research. Information on Vision Research: Needs, Gaps, and Opportunities is available at

Submissions must address why the audacious goal is important, how to achieve the goal, and how realization of the goal will impact the NEI mission. Submissions are limited to 4,000 characters including spaces (about one page), and must comply with rules outlined at

Entries will be de-identified and judged by NIH experts. Criteria include relevance to the NEI mission; whether the goal is bold, daring, unconventional, or exceptionally innovative; and feasibility. Goals should be broad in scope and attainable in about 10 years.

In the News…

Statin use reduces glaucoma risk. Taking cholesterol-lowering statin drugs to reduce the risk of cardiovascular disease can also be helpful in decreasing the risk of being diagnosed with open-angle glaucoma, according to a nationwide study of more than 300,000 patients.

University of Michigan School of Medicine researchers, headed by Joshua Stein, MD, MS, found that the risk for glaucoma was reduced by 8% in patients who took statins continuously for two years, compared with patients who did not take statins. The study, the largest to date on the topic, was published in the October issue of Ophthalmology. The study was spurred by growing evidence that statin use may protect the optic nerve and retinal nerve fibers.

The researchers used healthcare claims data for a diverse population of Americans age 60 and older who took statins to control high lipid levels in the blood. Unlike earlier studies, their analysis adjusted for patients who also had diabetes or hypertension, or both, to prevent distortion of the results.

Several of the study’s findings suggest that statin use may be most important before glaucoma is diagnosed, or in the early stages of the disease.

Sightpath marks 50,000 Intralase procedures. Sightpath Medical recently reached a milestone, having participated in more than 50,000 mobile Intralase procedures since adding this technology to its refractive offering in December 2007.

For the past 20 years, Sightpath has been providing on-demand ophthalmic equipment and services across the United States. The company says it makes advanced ophthalmic surgical services an economic possibility wherever and whenever they are needed, with both mobile and fixed-location solutions.

Membrane Removal and DMEK Graft Adhesion

Incomplete removal could risk detachment, study reports.

■ Complete removal of Descemet’s membrane (DM) in the area of the graft allows better adhesion following Descemet’s membrane endothelial keratoplasty (DMEK). This was the finding of a study that set out to determine the impact of the size of the descemetorhexis on graft adhesion.

The results showed greater overlap can be a risk factor for graft detachment. Looking at 100 eyes that underwent DMEK by the same surgeon, the study examined the zone between donor and graft DM. The amount of detachment was estimated as clock hours and the number of additional air injections needed for adhesion was defined. Significant graft detachment was defined as any area equal to or greater than three hours of circumference.

As a result, researchers were able to divide subjects into three groups. For the first group, the graft and patients DM overlapped completely. Fifteen patients fit into this group. No overlap was found in the second group, which comprised 21 patients. In that group the graft was separated from DM by a small gap. The third group comprised 69 patients with variable overlap. The first group suffered more severe detachment both in numbers and per individual.

Significant graft detachment appeared in 10 of the eyes in the first group while it was found in only three of the eyes in second group. Also, the eyes in the first group that showed detachment showed significantly greater detachment (3.5 ± 1.0 clock hours) as compared to the second group (0.9 ± 0.3 clock hours). Three of the eyes in the first group had persistent major detachment and had to undergo re-bubbling.

Faculty at the department of ophthalmology at the University of Erlangen-Nuernberg in Erlangen, Germany, performed this study.


Schlomberg, Juliane, et al. Extent of Removal Of Descement Membrane Determines Graft Adhesion in DMEK. 2012 ARVO E-Abstract

In the News …

FDA panel recommends retinal prosthesis. An FDA advisory panel voted unanimously to recommend approval of the Argus II retinal prosthesis that restores some functional vision to patients with profound vision loss from retinitis pigmentosa.

The device has three components, incliuding a video camera attached to special eyeglasses, a processing unit worn on a belt and an implanted retinal prosthesis that receives signals from the processing unit.

In a clinical trial, 18 of 27 patients were able to gain enough functional vision to walk straight on a sidewalk and 25 of 27 were able to determine if a person was walking toward them or away from them. Half of the patients could read very large letters from a foot away.

Canada approves KAMRA inlay for presbyopia. AcuFocus Inc. announced that Health Canada has approved its KAMRA corneal inlay for the treatment of presbyopia. The KAMRA inlay is an innovative treatment option that uses small-aperture optics to restore near and intermediate vision.

“The unique small aperture design of this inlay is a proven approach for extending depth of focus, with years of research and data behind it,” says Dr. Jeff Machat, Crystal Clear Vision, Toronto. “It is the only option where patients experience improvements in both near and intermediate vision as well as maintenance of distance vision.”

Dry eye therapy shows promise. SARcode Bioscience announced encouraging results from OPUS-1, a pivotal phase 3 study of lifitegrast ophthalmic solution, 5.0%, versus placebo for the treatment of dry eye disease.

In the study, which included 588 subjects, lifitegrast demonstrated superiority over placebo in the improvement of inferior and total corneal staining scores from baseline to week 12. Lifitegrast also significantly improved the most commonly reported symptoms of dry eye disease in the study, which were ocular discomfort and eye dryness. Lifitegrast was well tolerated and there were no unexpected or serious ocular adverse events.

Vision loss and coffee drinking. A new study suggests caffeinated coffee drinkers should limit their intake to reduce their chances of developing vision loss or blindness. According to an article in Investigative Ophthalmology & Visual Science, heavy caffeinated coffee consumption can be linked to an increased risk of developing exfoliation glaucoma, the leading cause of secondary glaucoma worldwide.

The study is the first to examine the link between caffeinated coffee and exfoliation glaucoma in a US-based population.