Practice pulse
HEALTH AND HUMAN SERVICES SECRETARY ANNOUNCES DELAY
ICD-10 Compliance Date to be Deferred, Says HHS
■ Health and Human Services (HHS) Secretary Kathleen G. Sebelius has announced that the HHS will start a process to defer the date by which healthcare entities covered under the Health Insurance Portability and Accountability Act of 1996 must comply with ICD-10 diagnosis and procedure codes.
“ICD-10 codes are important to many positive improvements in our healthcare system. We have heard from many in the provider community who have concerns about the administrative burdens they face in the years ahead,” she issued in a press release. “We are committing to work with the provider community to reexamine the pace at which HHS and the nation implement these important improvements to our healthcare system.”
In January 2009, ICD-10 was ruled as the new standard, and a compliance date of October 1, 2013 was set. In moving forward, the HHS will announce a new compliance date.
“SLIMMER” AND“ LIGHTER” EYEWEAR OPTION NOW AVAILABLE
U.S. Military Offers New Frames
■ The U.S. military has begun offering a new standard issue frame for those soldiers requiring eyewear.
“The style of the new basic issue resembles a slimmer and lighter frame that many of the trainees arrive already wearing,” Sgt. Brant Fechter, 43rd Adjutant General (Reception Battalion Optometry Clinic noncommissioned officer-in-charge at Fort Leonard Wood, in Mo. told the U.S. Army news.
The former standard issue frame, the S9, was nicknamed “birth control glasses,” or “BCGs,” as soldiers have said its thick-rimmed, square and brown appearance have made them look unattractive.
“The durability of the S9s might be better than the new 5As (left, below) because the frames are thicker,” says Sgt. Fechter. “However, soldiers will wear the new issue more often, which will improve training and performance.”
But will soldiers really wear the new frames more often? After all, chunky-rimmed-style frames are currently all the rage. Time will tell.
| Corrections: In the “Therapeutic Focus” column on Loteprednol ointment (OM, February 2012, page 18), we incorrectly stated the authors, Ron Melton, O.D. and Randall Thomas, O.D., had no financial relationship with Bausch + Lomb. The authors did, in fact, submit a disclosure statement with their manuscript, which stated they “are consultants to, or on the speakers bureau of, or involved in research for Alcon Laboratories and Bausch + Lomb.” We apologize for the error. In “Part 1: Corneal Breach” (OM, January 2012, page 48), William Edmondson, O.D., J. James Thimmons, O.D. and Jane Ann Grogg, O.D. should have been given credit for images 1 to 3, respectively. We apologize for these omissions. |
| AT PRESS TIME: We’ve learned that Irving M. Borish, O.D., lauded for his achievements to the optometric profession, has passed away. See page 6 (Viewpoint) for further information. |
| Campbell Alliance |
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| INVENTIV HEALTH There is room for growth in the multifocal lens category, according to the Q4 2011 Vision-Care Contact Lens Report. The industry’s leading contact lens dispensing panel, managed by Campbell Alliance’s market research and analytics group, found that among 76,856 U.S. contact lens patient visits recorded in 2011, a sweeping 96% of patients 50 years and older were presbyopic. Of these presbyopic patients, only 35% were fitted with multifocal contact lenses. An additional 37% were corrected using monovision, while the remaining 28% received sphere or toric lenses. Eyecare practitioners in the U.S. can join the contact lens dispensing panel to contribute to this important industry data and receive quarterly insights on contact lens fitting trends that impact their practice. Learn more at www.rxsurvey.com/join. To see more trends from the VisionCare Contact Lens Study, look for the 2011 Annual Summary in the April issue of Optometric Management. |
EYLEA POST-INJECTION STERILE INTRAOCULAR INFLAMMATION SEEN MOSTLY AT ONE PRACTICE
AMD Drug Adverse Event Linked Primarily with One Practice
■ Since the November launch of afilbercept (Eyelea, Regeneron Pharmaceuticals), an injectable treatment for neovascular age-related macular degeneration, 14 cases of post-injection sterile endophthalmitis has been reported at a rate of 0.05% per injection, with 11 of these incidences emanating from a six-doctor practice and nine linked with a single physician, Regeneron’s President and CEO Leonard Schleifer, M.D., Ph.D. says. Dr. Schleifer shared this during a Q4 2011 Earnings Results conference call in mid-February.
“We are working closely with the practice involved to better understand this cluster, and [we are] in the process of disseminating the information we have learned to retinal physicians,” Dr. Schleifer explains. “We have informed the FDA as per the normal course. To be clear, we do not believe the data available indicates that Eylea is responsible for this cluster.”
Why not? The answer is that the reported cases could not be traced to a single lot of drug, nor a single delivery of commercial vials, Dr. Schleifer says. In addition, he says vials from the same lot have been used widely throughout the country.
He added that when excluding this six-doctor practice, the rate of reported post-Eyelea sterile endophthalmitis was 0.01%, or 1 in 10,000. Thus far, 30,000 doses have been administered nationwide.
When asked whether the company has any “working hypothesis” on these cases, Dr. Schleifer replies that Regeneron is “looking at everything.”
“We do know that these patients, we believe they were switched from both Avastin and Lucentis. The doctors there [at the six-doctor practice] are experienced, so were not sure what’s different,” he explains. “We do know that they’re using a different needle than the one that we supply. We don’t know if that’s the issue. Frankly, these clusters occur, and sometimes you just never figure it out…”
| FDA News |
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| ■ Tafluprost (Zioptan, Merck & Co.), a preservative-free prostaglandin analog, has received FDA approval for the treatment of open-angle glaucoma. ■ HuCNS-SC cells, from StemCells, Inc., have received FDA authorization to undergo a Phase I/II clinical trial for the treatment of age-related macular degeneration. Preclinical data demonstrated that HuCNS-SC cells protected host photoreceptors and preserved vision in rats who had retinal disease. ■ The second-generation LipiFlow Thermal Pulsation System, from Tear-Science, has received FDA clearance and becomes commercially available this month. (See this month’s Dry Eye Column, page 66.) The device treats evaporative dry eye via liquefying and evacuating obstructions in the meibomian glands, the company says. Further, it features simultaneous treatment, an enhanced graphical user interface and patient record storage. |
| RESEARCH Notes |
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| • After playing an action video game for 40 hours through a month, patients born with bilateral cataracts who had their vision “corrected” via surgery, though still experienced specific visual processing deficiencies into adulthood, saw improvements in their ability to view small print, the direction of moving dots and identify faces, explained McMaster University psychologist Daphne Maurer at the American Association for the Advancement of Science meeting, held in Vancouver, B.C. February 15th. These improvements indicate that the adult brain is still plastic enough to be trained to overcome sensory deficiencies, she says. • The topical corneal application of Aganirsen, an antisense oligonucleotide-inhibiting insulin receptor substrate-1, weakened neovascular lesion development dose-dependently in African green monkeys who underwent laser-induced choroidal neovascularization, reveals the Feb. 9 issue of Investigative Ophthalmology & Visual Science. In addition, it inhibited retinal neovascularization post-oxygen-induced retinopathy in newborn rats and did not interfere with the physiological retinal vessel development in these rats. These findings support clinical testing of Aganirsen in human retinal neovascular disease, the study’s researchers say. • Dry eye disease appears to be a common occurrence in children who have juvenile rheumatoid arthritis, and it highly correlates with the disease activity, says July’s European Journal of Ophthalmology. Therefore, these patients should be screened for the condition, the study’s researchers say. • Punctal plugs appear a safe and effective treatment for children who have persistent dry eye syndrome symptoms, especially since adherence to frequent lubrication is a challenge with these patients, says January’s British Journal of Ophthalmology. • Adult retinitis pigmentosa patients who consume a diet rich in omega-3 fatty acids and vitamin A may experience slow mean annual rates of decline in distance and retinal visual acuities, says February’s Archives of Ophthalmology. • Assuming optimal drug compliance, prostaglandin analogs (PGAs) provide greater cost–effectiveness in the treatment of newly diagnosed mild open-angle glaucoma patients than laser trabeculoplasty (LTP), says February’s Archives of Ophthalmology. However, when taking into account the reality of compliance to PGAs, LTP may be a more cost-effective choice for these patients. • Subthreshold diode laser MicroPulse photocoagulation results in enhanced visual acuity and macular perimetry in central serous chorioretinopathy patients, says November’s Eye (Lond). • A targeted, sustained-release drug delivery system comprised of steroids and using a nanodevice construct successfully treated the damagecausing cells linked with neuroinflammation in rats, while leaving the rest of the eye unaffected and preserving vision, says January’s Biomaterials. Specifically, one intravitreal administration of the nano device in microgram quantities offered neuroprotection for at least a month. As a result, this technique may be a potential treatment for AMD and retinitis pigmentosa, the researchers say. • A grape-rich diet appears to slow and prevent the onset of AMD, says a study in December’s Free Radical Biology and Medicine. Specifically, a grape-enriched diet proved protective against oxidative damage of the retina and prevented blindness in mice prone to developing retinal damage in old age. • Vitamin D appears to protect against AMD, says a study in January’s Neurobiology of Aging. Specifically, middle-aged mice who took the vitamin for six weeks showed significant decreases in retinal inflammation and levels of amyloid beta accumulation, which is a hallmark of aging. Additionally, these mice had substantial reductions in retinal macrophage numbers and marked shifts in their morphology. • Increasing age (75 years and older) and female gender appear significant risk factors for exfoliation glaucoma (EG) or becoming an exfoliation glaucoma suspect (EGS), says January’s Ophthalmology. Also, residing in the middle or southern U.S. regions compared with living in the northern region was linked with a decreased risk of EG or EGS. • The Phase II clinical trial on RGN-259, a sterile, preservative-free drop for dry eye syndrome, from RegeneRx Biopharmaceuticals, Inc., revealed the drug had a clinically relevant and statistically significant effect on the treatment of primary dry eye signs and symptoms, was safe and well-tolerated, the company issued in a press release. (For the full press release, visit www.regenerx.com/ wt/page/pr_1325770801.) • OphthaliX, Inc. (formerly Denali Concrete Management Inc.), has announced it’s begun patient enrollment for a phase III clinical study of the safety and efficacy of CF101, an oral A3 adenosine receptor agonist, for the treatment of moderate-to-severe dry eye syndrome. The multicenter, randomized, double-masked clinical trial will be comprised of 231 patients who will receive either two doses of CF101 or a placebo for six months. CF101 is also being developed to treat glaucoma and uveitis. |
CALIFORNIA OPTOMETRIC ASSOCIATION PASSES SUPPORTING RESOLUTION
COA Backs Stand-Alone Vision Plans
■ The California Optometric Association (COA) House of Delegates has passed a resolution that supports the inclusion of stand-alone vision plans in the state’s Insurance Exchange, according to a COA press release.
“… Stand-alone plans provide access for patients to continue seeing their optometrist for eyecare and can be a valuable channel to make sure optometrists are fully integrated as the primary providers for patients’ vision and medical eyecare,” says COA President Movses D’Janbatian, O.D. “We will continue to work with these plans to ensure doctors don’t lose their patients.”
Tim Jankowski, O.D., F.A.A.O., chairman of the VSP Board of Directors and a COA member, says he’s pleased the COA House of Delegates “overwhelmingly reaffirmed the critical role that stand-alone plans have in providing access to patients for optometry as the healthcare landscape continues to change.”
He adds that VSP and the COA are committed to working together to create programs that support full medical integration for O.D.s. An online petition in support of standalone plans is available at http://vsp provesit.com/online-petition.
In response to this news, American Optometric Association (AOA) President Dori Carlson, O.D., says that the AOA recognizes that VSP has a “uniquely high penetration” in the visioncare market in California, that they were successful in delivering the message that they aren’t being allowed into the new insurance exchanges, and, as a result, threatening the livelihood of California O.D.s. She adds, however, that stand-alone vision plans can be in the exchanges if they simply contract with a Qualified Health Plan (QHP).
“The AOA supports the notion of a QHP including a comprehensive eye examination by an eye doctor as an integrated medical benefit, which can certainly be provided through a stand-alone vision plan as long as provider scope of practice and payment parity is fully recognized,” she says. “We believe that this is the basis for working together with a stand-alone plan.”
| Revamped Clinical Reference Site | |
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| The website EyeDock.com is an online clinical reference for eyecare professionals that includes searchable databases for contact lenses and ocular pharmaceuticals, as well as calculators you can use for prescribing contact lenses, an ICD-9 look-up and patient and clinical education tools. In addition to these features, the newly revamped site includes a database of 1,200 gas permeable contact lenses and an interactive refraction tutorial. And yes, there is an iPhone app for the site. |
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ANNUAL ACADEMY ALSO AWARDS O.D. PRACTICE
Transitions Launches Polarizing Lens
■ Transitions Optical launched Transitions Vantage, a lens designed to both darken and polarize upon UV exposure. The company announced this photochromic lens, which incorporates variable polarization technology, at the 16th annual Transitions Academy held recently in Orlando, Fla.
The adaptive lens technology was made possible by a new type of photochromic dye in which molecules not only darken when exposed to UV, but also align to create polarization. Therefore, the darker the lenses become, the greater the polarization. Prior to the introduction of this technology, photochromic molecules darkened in random patterns. Polarization in sunwear relied on a fixed film.
The lens will be offered to consumers as an everyday lens, available in gray, in a variety of materials and designs, beginning in May.
Also during the Academy meeting, Transitions named Preferred EyeCare Center, Mount Pleasant, N.C., as Transitions Eyecare Practice of the Year, recognizing the practice for its efforts to promote healthy sight and Transitions products within its practice and local community. In addition, Optical Prescription Lab, Pelham, Ala., was named the 2011 Transitions Lab of the Year.
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