At Press Time
Same-Day Cases Remain an Issue
CMS to ASCs: Only Emergency Procedures Permitted.
By Jerry Helzner, Senior Editor
■ CMS has reached a compromise with ASC advocacy organizations on the issue of same-day scheduling, but for many ASC operators the compromise leaves a lot to be desired.
It all started when the CMS announced a new ruling that no patients could undergo a procedure in an ASC on the same day the procedure was scheduled. This ruling, which was to go into effect in May, did have an underlying rationale. CMS contended that because many ASC procedures are elective, patients needed more than a few hours to make an informed decision as to whether they wanted to go ahead with the surgery.
However, the Outpatient Ophthalmic Surgery Society (OOSS) and other ASC advocacy organizations pointed out that people do at times experience medical emergencies that require immediate attention.
The logic was compelling. CMS recently reversed its original ruling and said it would permit same-day scheduling of ASC procedures if the referring physician indicates in writing that the procedure is medically necessary and that an ASC is the appropriate setting in which to perform the procedure.
However, for non-emergency cases, especially in rural areas, this exception does not apply and creates a hardship of additional paperwork and multiple trips for mainly elderly patients. (See the "Viewpoint" column by Dr. Patterson in this issue.)
In addition, CMS warned that it will monitor the number of same-day cases for issues of noncompliance.
On another ASC-related issue, OOSS announced that it is backing H.R. 2049, The Ambulatory Surgical Center Access Act of 2009. The legislation would improve patient access to ASCs and increase facility payments to centers. Specifically, the bill would:
► stop projected payment cuts by fixing ASC payments at 59% of hospital outpatient departments
► preclude CMS from manipulating rates downward by imposing arbitrary budget neutrality adjustments
► provide ASCs with the same annual inflation update provided to hospitals
► improve ASC payments for implantable devices
► provide guidance to CMS if quality and cost reporting is implemented in the future
OOSS says that enactment of H.R. 2049 would enhance Medicare revenues for ophthalmic services by 12% to 13%.
| IN THE NEWS |
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| ■ New warning on tamsulosin. Spurred by a new, large-scale Canadian study linking tamsulosin (Flomax) to postoperative cataract surgery complications, the American Academy of Ophthalmology and the American Society for Cataract and Refractive Surgery have updated their joint statement cautioning patients to inform their ophthalmologist that they are taking (or have taken) the drug prior to ocular surgery. The updated AAO/ASCRS advisory contains information about the results of the new study. The study reports that men taking tamsulosin for benign prostatic hyperplasia (BPH) are at higher risk for adverse events following cataract surgery than men taking other α-blockers for BPH. Tamsulosin has already been directly associated with a potentially serious intraoperative complication known as intraoperative floppy iris syndrome, but this is the first large study of postoperative complications. The updated advisory is being accompanied by increased informational outreach aimed at family physicians who, along with urologists, are the major prescribers of tamsulosin. Researchers at St. Michael's Hospital, Toronto, reported in the Journal of the American Medical Association that in a total of more than 96,000 cataract surgery patients evaluated, those who were recently dispensed tamsulosin had 2.3 times the risk of postoperative adverse events such as retinal detachment, lost lens, lens fragments or suspected endophthalmitis. A JAMA editorial accompanying the new research suggested a "black box" warning for tamsulosin. The drug's patient information insert currently contains advice that patients considering cataract surgery should inform their surgeon that they are taking the drug and that surgeons should be prepared to possibly modify their surgical technique. ■ B&L anti-infective approved. Bausch & Lomb said that the FDA has approved Besivance (besifloxacin ophthalmic suspension) 0.6% for the treatment of bacterial conjunctivitis. Besivance is a new topical ophthalmic antibacterial, administered via sterile ophthalmic drops, that treats a wide range of eye pathogens. In December 2008, an FDA advisory committee voted unanimously to recommend approval of Besivance. B&L says that Besivance is the first fluoroquinolone specifically developed for ophthalmic use and is the first and only ophthalmic fluoroquinolone with no previous systemic use. It offers broad-spectrum antibacterial activity, including efficacy against the strains that are the most common causes of bacterial conjunctivitis, as borne out in trials involving nearly 2,400 patients, according to B&L. Besivance is now available by prescription in U.S. pharmacies and will be promoted by both the Bausch & Lomb and Pfizer, Inc. sales forces under a recent co-marketing agreement. ■ Nidek founder dies. Hideo Ozawa, who founded Nidek Co., Ltd. in 1971 and built it into one of the largest broadly based ophthalmic instrument companies in the world, has died at the age of 79. At the time of his death, Mr. Ozawa served as chairman of Nidek, which is based in Gamagori, Japan. Mr. Ozawa, who had a background in bio-optics, was a pioneer in merging electronics and optics to develop "optoelectronic" ophthalmic instruments, encompassing such areas as diagnostics, laboratory equipment and lasers. In 2004, Mr. Ozawa received the prestigious "Order of The Rising Sun" from the Japanese government. He also served for years as chairman of the Japanese Ophthalmics Instrument Association. ■ Extended-release RVO drug approved. The FDA has approved Allergan's Ozurdex (dexamethasone intravitreal implant) 0.7 mg as the first drug therapy indicated for the treatment of macular edema following BRVO or CRVO. Ozurdex (formerly Posurdex) was developed to meet the challenges of intravitreal corticosteroid therapy. It employs the novel Novadur solid-polymer intravitreal drug-delivery system that gradually releases dexamethasone over a period of months while the carrier matrix slowly degrades into carbon dioxide and water, eventually dissolving completely. Like other steroids, dexamethasone appears to inhibit the inflammatory processes involved in retinal vascular disease. Because it is water soluble and has a very short half-life in the vitreous, sustained-release delivery is a preferred method to provide continuous treatment. Ozurdex is placed in the vitreous cavity during an in-office procedure. In clinical studies, 20% to 30% of patients with retinal vein occlusions experienced a 3-line improvement in BCVA with an onset of effect within the first 2 months following therapy. |
New Details on Aquashunt Design
Opko Glaucoma Shunt Offers Simpler Implantation.
■ When Opko Health acquired the investigational Aquashunt glaucoma shunt through its purchase of Vidus Ocular last year, Opko presented the device as an advance in shunts whose design and relatively simple implantation procedure could overcome the limitations of existing drainage devices.
Much recent interest has been focused on the Aquashunt for two reasons. First, recent data from the Tube vs. Trabeculectomy study has shown that, in many cases, shunts are a more desirable treatment option than previously thought. Second is the fact that the device's inventor is M. Bruce Shields, M.D., a highly respected glaucoma specialist.
Dr. Shields, chairman emeritus of the Department of Ophthalmology and Visual Science at Yale University School of Medicine, has developed a device composed of a biocompatible material that conforms to the shape of the eye. The Aquashunt drains aqueous humor from the anterior chamber to the suprachoroidal space between the sclera and choroid layers of the eye without the need for a bleb. In a normal, healthy eye this space handles approximately 20% of the aqueous fluid outflow. Published studies have demonstrated that this drainage pathway is capable of handling a greater volume of outflow, which may enable the Aquashunt to provide a clinically meaningful and durable reduction of IOP.
"We designed Aquashunt with the goal of translating our extensive experience in treating glaucoma into a new type of therapy that would leverage physiologic principles to treat patients more safely, effectively and economically," said Dr. Shields.
Ben Bronstein, M.D., executive vice president of R&D for Opko Instrumentation, briefly provided more details of the design and implantation procedure for the Aquashunt to Ophthalmology Management.
"Implantation of the Aquashunt requires a single full-thickness incision of the sclera to the level of the suprachoroidal space," explains Dr. Bronstein. "The shunt is then advanced through the suprachoroidal space with an insertion tool, which also serves as an obturator that keeps tissue from blocking the lumen."
Dr. Bronstein says that the Aquashunt's shearing leading edge separates the adhesion between the ciliary body and scleral spur. The shunt's forward advancement into the anterior chamber is limited by the shunt's "shoulders," which are set 3 mm back from the leading edge.
"After placement of the shunt tip in the anterior chamber, the Aquashunt is secured to the sclera with a single non-biodegradable suture. The distal end of the shunt is tucked beneath the posterior lip of the scleral incision, and the scleral incision is then closed," says Dr. Bronstein. "The entire procedure can be performed in approximately 15 to 20 minutes. The simplicity of design that makes implantation relatively quick and easy."
Having successfully completed preclinical studies demonstrating in vivo IOP reduction and biocompatibility, the Aquashunt is currently in a small human clinical trial in the Dominican Republic.
RESEARCH DIGEST
Risk Factors Identified for Failed Corneal Transplants
■ Corneal transplant failures. Patients who have undergone cataract surgery prior to corneal transplant for corneal edema are about four times more likely to have a failed transplant than patients whose edema was caused by Fuchs' dystrophy.
Researchers led by Alan Sugar, M.D., F.A.C.S., of the University of Michigan, reviewed 1,090 cases and published their findings in the June issue of Ophthalmology. The researchers found that swelling of the cornea caused by cataract surgery caused transplant failure in 27% of patients. Fuchs' patients had only a 7% failure rate. In addition, glaucoma patients, particularly those who had both medical and surgical treatment for the disease, had a far higher transplant failure rate than those patients who did not have glaucoma.
Age, gender, smoking and history of diabetes appeared to have no impact on transplant failure rates, the researchers found.
■ New data from China. The authors of the second Beijing Eye Study, conducted by questionnaire in 2006, have published their data in the May 2009 issue of Acta Ophthalmologica. The researchers interviewed 3,251 patients or 73.2% of the subjects paneled in the original study, which was conducted in 2001 among patients ≥40 years old.
Among the authors' findings were that the three most common causes of vision loss or impairment were cataract, degenerative myopia and glaucoma. This is in contrast to a Western population, where AMD and diabetic retinopathy make up a much larger percentage of cases of vision loss. The authors correlated the lower rate of AMD and diabetic retinopathy with certain anatomical differences in the eyes of Chinese patients vs. European and North American patients — particularly Caucasians.
The study also found that 20% of those interviewed had symptoms of dry eye. These results were associated with age, gender (women having the condition more often), urban region and undercorrection of visual acuity.
■ Dry eye could be Sjögren's. Some patients who present with symptoms of dry eye could actually have primary Sjögren's syndrome. According to a study by Wilmer Eye Institute, researchers in the June issue of Cornea, a salivary gland biopsy may be required to reach a definitive diagnosis.
The retrospective review identified 220 patients with dry eye syndrome, including 57 patients with an underlying rheumatic condition, 25 patients with rheumatoid arthritis and 24 patients with a final definitive diagnosis of primary Sjögren's syndrome. Eight of the 24 patients who were definitively diagnosed with Sjögren's required a salivary gland biopsy to confirm the diagnosis.
■ Intracameral cefazolin and endophthalmitis. Researchers from L'Hospitalet de Llobregat, Barcelona, Spain, found low endophthalmitis incidence after cataract surgery at the hospital in the 4 years following the addition of a prophylactic 2.5 mg/0.1 mL intracameral bolus of cefazolin at the end of surgery. Infection rates were much higher in the 2 years before the addition of cefazolin. A total of 18,579 cases were reviewed for endophthalmitis incidence. The endophthalmitis rate was 0.047% after cefazolin introduction compared with a much higher rate of 0.422% in the pre-cefazolin group, according to a recent issue of the Journal of Cataract & Refractive Surgery.
■ Endophthalmitis remains rare following phaco. A team of researchers at the University of Toronto published data in a recent issue of Ophthalmology suggesting that, despite concerns about antibiotic-resistant infection, endophthalmitis remains a rare complication of phacoemulsification.
The study, conducted by Chaim M. Bell, M.D., Ph.D., and Wendy Hatch O.D., M.Sc., found that the rate of endophthalmitis following cataract removal was 1.4 per 1,000 surgeries among facilities in the province of Ontario where at least 50 surgeries were performed yearly. More than 440,000 patients were followed between April 2002 and March 2006.
The key factor identified by Drs. Bell and Hatch was lens-capsule rupture, which caused the rate of endophthalmitis following surgery to be 10 times higher than in other patients. However, this complication occurred in fewer than 1 in 200 patients. While rates of endophthalmitis were slightly higher in patients over 85 years old and in men, there were no differences based on socioeconomic status or geographic location.
■ Regrowing lymph vessels in burned corneas. Scientists in China have reported in the May 2009 issue of Acta Ophthalmologica that lymphatic vessels in the cornea are able to develop after the corneas sustain alkali injuries. In a rat model, scientists examined alkali-burned corneas at 6 hours, 1 day, 3 days, and 1, 2, 3, 4, 5, 6, 7 and 8 weeks following injury. The team observed increasing levels of vascular endothelial growth factor (VEGF)-C, a key factor in lymphangiogenesis, implying that VEGF-C may play a key role in the healing of alkali burns to the cornea. OM
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