Giving
Dry Eye Its Due
A model for focusing on dry eye care and harnessing its practice-building power.
By Salvatore DeCanio, O.D., and Tom Coffman, M.D.
At Visual Health & Surgical Centers in southeast Florida, a multi-subspecialty practice, we see approximately 120,000 patients each year. A significant number of those patients have dry eye or dry-eye-related symptoms. Many have been successfully treated, but many others have not because accurate evaluation and diagnosis are so difficult to accomplish. As we now know, dry-eye symptoms can have multiple, overlapping causes. And treatment plans, therefore, tend to be hit-or-miss.
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Visual Health & Surgical Centers has designated four of its 16 locations as tear-collection stations. One is its flagship facility, located at
CityPlace, a new, upscale retail shopping
and entertainment village in downtown West Palm Beach, Fla. |
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For us, this represented a perfect opportunity to satisfy a definite patient need and add value to our practice at the same time. We decided to establish what we call our Dry Eye Treatment Center. It's as much a commitment to focus on our mission of always being at the forefront of eyecare technology as it is a physical place. As of mid-October, the Center was up and running.
In this article, we'll give you an idea of what that entails.
Assessing new strategies and technologies
After researching all of the available tools and technologies that would help make our approach successful, we elected to begin recommending branded dry-eye-specific nutritional supplements to patients we think could benefit from them in addition to the mainstay dry eye treatments. We sometimes recommend that patients take flaxseed oil, if they're not also taking blood thinners, and their primary physician OKs it.
We also purchased Corneal Science Corp.'s Tear Profile System, which serves as the centerpiece of the Dry Eye Treatment Center. (See "Obtaining the Latest Dry-Eye Technology".)
The instrument provides an objective, quantifiable measurement of the concentration of the protein lactoferrin in the tear film. Protein-sufficient tears do for the eye what blood does for the rest of the body. They deliver oxygen, nutrition for corneal metabolism and infection protection, as well as growth and repair chemicals.
Lactoferrin is secreted by the epithelial acinar cells of the lacrimal glands and is considered a good marker for assessing secretory function. It plays a vital role in virtually all ocular surface diseases. According to the National Eye Institute's Dry Eye Monograph, lactoferrin testing is the only diagnostic method accurate enough to be considered a confirmatory test for tear-deficiency dry eye. In addition, it's been shown to be 99.7% accurate as opposed to other methods such as TBUT, Rose Bengal staining and Schirmer paper strips, which combined are reportedly only 52% accurate and also nonspecific in providing diagnostic information.
The Tear Profile System also allows us to determine immunoglobulin E (IgE) concentration in the tear film. Elevated levels of IgE are indicative of ocular allergy or an allergic component of the inflammatory response in dry eye.
What these tests give us is a more accurate and efficient way to:
- figure out whether a red eye is dry eye or allergy
- distinguish between allergic dry eye, evaporative dry eye and tear-deficient dry eye (thereby determining whether punctal occlusion would be an effective treatment)
- treat dry eye or dry-eye-related symptoms prior to LASIK to achieve the best outcomes (Low levels of preoperative lactoferrin have been shown to correlate with undercorrections; high levels of the protein have correlated with overcorrections.)
- predict the success of contact lens patients and monitor their corneal health
- differentiate between an allergic response and a bacterial or viral response in the red eye.
Based on that type of specific diagnostic information, we can provide better patient care because we can choose the most effective treatment for each case.
What is CLIA? |
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In 1988, Congress passed Clinical Laboratory Improvement Amendments (CLIA) that established quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test is performed. A laboratory is defined as any facility that performs laboratory testing on specimens derived from humans for diagnosing, preventing or treating disease, or assessing health. Therefore, to be reimbursed for microassay tear-testing, a practice must be CLIA-certified and obtain a CLIA number. Federal and state fees are required. At the outset, the federal fee is $400; state fees vary and increase according to the number of tests performed. An initial inspection, to assess good laboratory procedures and compliance with other requirements, is conducted. An inspection for recertification is conducted every 2 years. According to Corneal Science Corp., a company that markets a tear-testing instrument, for the first 2 years, all of the relevant fees usually amount to approximately $17 per month. And after the first 2 years, they are less, amounting to approximately $10 per month. For more information on CLIA, visit www.fda.gov/cdrh/clia. |
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Laying the groundwork for a more focused approach to dry eye care
We knew from the outset that instrumentation alone wouldn't be enough to render our new dry-eye-fighting focus a success. One person would need to spearhead the effort. Dr. DeCanio stepped into the role of director and committed to spending a certain portion of each work week making sure the Dry Eye Treatment Center stays top-of-mind for all of our doctors and staff.
He began almost a year ago by sending all of our physicians a memo alerting them to the upcoming establishment of the Center and the services it would offer. Multiple reminders and updates have since been sent, and the topic has been discussed at staff meetings. Dr. DeCanio has also met with all of our doctors individually to engage their support and encourage them to refer patients to the Treatment Center when appropriate.
The idea should appeal to our surgeons, especially because ocular surface disease is a main component of dry eye, particularly in elderly patients. Referring them to the Treatment Center allows surgeons to spend less time diagnosing and treating dry eye and more time performing procedures and providing care at their highest levels of expertise.
No new staff members have been hired so far, although we may find additions necessary and feasible in the future. We've designated four of our 16 office locations as "tear collection stations," where patients who've been referred from other areas of the practice can go to have their tear samples drawn or otherwise be diagnosed and treated. Dr. DeCanio will spend a half day per week in each of those four locations. One staff member at each location has been trained to draw the samples. A small learning curve is associated with performing the lactoferrin and IgE tests properly. Four steps are required:
- a micropipette is placed in the cul de sac to draw the tear sample
- for lactoferrin, the sample is released into a vial that contains diluent; for the IgE test, the sample is placed directly onto an immunoassay card
- from the vial, the lactoferrin sample is placed onto an immunoassay card
- the cards are then processed through the tear-testing unit, which provides a quantitative value for proteins.
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As part of the internal marketing plan for its Dry Eye Treatment Center, Visual Health & Surgical Centers created a one-page informational flyer to be mailed with the 3,000 statements it sends out each month. |
Processing the cards is time-consuming (up to 6 minutes), and samples to be tested for IgE have to be tested the same day as they're drawn. But tears mixed with the lactoferrin reagent can last up to 2 weeks refrigerated before they're placed on the cards to be processed.
Our central appointment desk staff members are also involved in the Dry Eye Treatment Center effort. They've been educated about the Center and will refer patients whose chief complaint is dry-eye-related directly to Dr. DeCanio.
Dedicated scheduling templates for his consultations and treatments have been incorporated at each of the four designated locations. We've also incorporated three other administrative tools specifically for the Center: a checklist for symptoms and related history, a testing and treatment flow sheet, and a check-box treatment plan handout for patients.
Once details of how the Center would begin running were ironed out, we proceeded with an internal marketing strategy. We created a flyer highlighting the services offered and instructing patients how to inquire about them. We mailed the flyers with the approximately 3,000 statements we send out each month. We also displayed the information at check-in and check-out desks, reception areas and sub-waiting rooms in all of our locations. And we notified our well-established medical and optometric referral sources.
Off to a good start
By the time the Dry Eye Treatment Center was launched in mid-October, we had patients scheduled through the end of the month. Given our vast patient base, we expect to be progressively busier and that the Center will be a viable source of income.
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The Corneal Science Tear Profile System assesses lactoferrin and IgE levels via tear samples, which are placed on immunoassay cards. |
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Our initial investment in the tear-testing technology was approximately $20,000, which included the instrument and initial testing materials. Additional kits for testing lactoferrin cost $345 and contain enough supplies to test 20 eyes. Each IgE kits also covers 20 eyes and costs $445. That works out to a cost of $17.25 per lactoferrin test and $22.25 per IgE test. The cost of the supplies decreases with volume.
Each test has been assigned its own CPT Clinical Laboratory Procedure code: 83520 for lactoferrin and 82785 for IgE. At this time, it appears that the tests are reimburseable by Medicare and other carriers separate from and in addition to the comprehensive eye exam. The Medicare reimbursement rate is approximately $36 for a bilateral lactoferrin test and approximately $46 for a bilateral IgE test, which means revenue is just about double costs. Based on office visits, testing and treatments, we expect each patient to yield at least $200 in revenue.
Reimbursement rates and policies could, of course, vary by state. And because the tests are relatively new, reimbursement policies are not entirely clear and could change as more practices begin to submit claims. We also expect that a large number of patients would be willing to pay out-of-pocket, perhaps for example, as part of their LASIK fee, given the utility of the tests in treatment planning.
Quality care is our bottom line
Separate from a revenue issue, however, we see the Dry Eye Treatment Center as adding value to our practice for our patients. Essentially, it focuses enhanced attention on dry eye issues, leading us to more effective treatment regimens, resulting in happier patients -- the true essence of practice growth opportunity.
Tom M. Coffman, M.D., is the sole owner of Visual Health & Surgical Centers, a 16-office comprehensive eyecare practice in southeast Florida with 14 ophthalmologists and 8 optometrists on staff. Salvatore M.DeCanio Jr., O.D., joined the practice in 2001 after serving for 4 years as the executive director of TLC Laser Eye Centers in Boca Raton, Fla. For the 18 years prior to that, he owned a multioffice private practice in the same southeast Florida area.
Touch Scientific Inc. is the developer and manufacturer of the microassay tear-testing technology described in the accompanying article. Two diagnostic instruments that incorporate the technology are available: Tear Profile System (Corneal Science Corp.). This unit measures lactoferrin concentration and immunoglobulin E (IgE). An IgE test helps to separate the allergy-induced components of dry eye from the nonallergic components and an allergic response vs. a bacterial or viral response.
Lactoferrin level may be an indicator of LASIK results. Low levels of preoperative lactoferrin have been shown to correlate with undercorrections; high levels of the protein have correlated with overcorrections. Surgeons can use punctal plugs prior to LASIK to achieve a more normal lactoferrin measurement prior to performing the procedure. The Tear Profile System is part of Corneal Sciences' trademarked "The Dry Eye Solution," which includes preservative-free drops, punctum plugs, a gas-permeable contact lens with a hydrophilic surface, and assistance filing for a CLIA number, which practices must obtain in order to be reimbursed for tear-testing. (See "What is CLIA," on page 44.) Reagentless chemistry that will be introduced into this system is currently in beta-site testing. Tear Film Analyzer (CIBA Vision Inc.). This unit measures the lactoferrin concentration in the tear film, which determines whether a patient's dry eye is due to aqueous (tear) deficiency. The American Academy of Ophthalmology has stated that the proper use of punctual occlusion is only for moderate to severe aqueous-deficient dry eye. A reagentless version of this unit is in beta testing for lactoferrin. Both companies agree that not having to use reagents will make the tests quicker and less cumbersome.
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