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News
FDA Seeks Recommendations About Transparency
Earlier this year, President Obama issued a memorandum in which his presidential administration pledged to "work together to ensure the public trust and establish a system of transparency, public participation, and collaboration."1 In response, the FDA formed the Transparency Task Force. The group plans to develop recommendations based on the public's suggestions regarding how to make information about the FDA's activities and decision-making process more readily available in a useful, understandable, timely, and user-friendly manner. Citizens will have the opportunity to contribute comments to the task force through blogging, public docket, and public meetings.
"Our administration is committed to making government open and transparent," said Health and Human Services Secretary Kathleen Sebelius in a news release. "The Transparency Task Force will give the American people a seat at the table and make the FDA more open and accountable."
The task force will be chaired by Principal Deputy Commissioner Joshua Sharfstein, MD, and will include center directors, the associate commissioner for regulatory affairs, the chief scientist, and the chief counsel. According to the FDA's Web site,2 the task force will
- Seek public input on issues related to transparency
- Recommend ways that the agency can better explain its operations, activities, processes, and decision making in ways that are compatible with the agency's goal of appropriately protecting confidential information
- Identify information the FDA should provide about specific agency operations and activities, including enforcement actions and product approvals
- Identify problems and barriers, both internal and external, to providing useful and understandable information about FDA activities and decision making to the public
- Identify appropriate tools and new technologies for informing the public
- Recommend changes to the FDA's current operations, including internal policies and guidance, to improve the agency's ability to provide information to the public in a timely and effective manner
- Recommend legislative or regulatory changes, if appropriate, to improve the FDA's ability to provide information to the public
- Submit a written report to the commissioner on the Transparency Task Force's findings and recommendations
Cataract & Refractive Surgery Today contacted Priscilla Perry Arnold, MD, the chair of the Government Relations Committee of the ASCRS, to find out what impact the task force may have on ophthalmology. "The ASCRS is pleased at the announcement by the new FDA commissioner, Margaret A. Hamburg, MD, of the establishment of a task force to address issues of transparency," Dr. Arnold stated. "The ASCRS has particularly been interested in the transparency of medical device approval. We have submitted comments and appeared in person before the agency and hope to continue the dialogue in a positive manner for the benefit of the patients of ASCRS members."
Kerry D. Soloman, MD, is chairman of the ASCRS FDA Committee and is responsible for communicating with the FDA. "The ASCRS FDA Committee is eager to provide suggestions through the formal comment process that has been opened by [the] FDA as a result of its new transparency initiatives," Dr. Solomon wrote in an e-mail to CRSToday. "We believe this is a perfect opportunity for us to bring some of our concerns about the medical device approval process, particularly with ophthalmic devices, to the forefront. Essentially, the concerns we've raised in the past dealt with transparency and the need for clear understanding of the FDA's process by industry, the ophthalmic community, and the public. We're hopeful this administration will bring about necessary changes to that process so we, as ophthalmologists, can utilize the latest technologies to treat our patients."
CMS Propose Payment and Policy Changes for 2010
The Centers for Medicare & Medicaid Services (CMS) project a 21.5% reduction in physician payments, according to a proposed rule on the 2010 Medicare Physician Fee Schedule.
Based on data from the Physician Practice Information Survey, conducted by the AMA, the CMS plans to increase ophthalmology's practice expense per hour from $103.28 to $170.08, yielding an overall 11% increase in the cost of ophthalmic services, according to an ASCRS news release.
Jim Denning is the chief executive officer of Discover Vision Centers in Kansas City, Missouri. Via e-mail, he told Cataract & Refractive Surgery Today that, when the 2010 conversion factor is applied and the $329 billion Congress has appropriated for additional physician payments are added in, a rebasing will occur to the projected fee schedule. "I think the 2010 physician fee schedule will be plus or minus 1% from the 2009 levels when the final fee schedule is released on November 1, 2009," Mr. Denning wrote.
The proposed fee schedule will also implement two ophthalmic criteria to the Physicians Quality Reporting Initiative: 20/40 or better visual acuity within 90 days after cataract surgery and postoperative complications within 30 days after cataract surgery that require additional surgical procedures, the ASCRS stated.
The CMS is also proposing to remove physician-administered drugs (part B) from the sustainable growth rate calculation. "For ophthalmology, this would apply to expensive drugs such as Lucentis [Genentech, Inc., San Francisco, CA], Macugen [Eyetech Pharmaceuticals, New York, NY], and Visudyne [Novartis Pharmaceuticals Corporation, East Hanover, NJ]," Mr. Denning stated. "If these drugs are removed from the sustainable growth rate calculation, it could offset a large majority of the projected negative updates to the fee schedule in coming years. The positive effect would start to incur in 2011."
The elimination of consultation codes is also under consideration. "Based on audits performed by the Office of Inspector General, 75% of consultation codes billed did not meet consultation standard," Mr. Denning wrote. "The simplest way to rectify this problem is to eliminate the codes."
The CMS will accept comments on the proposed rule until August 31, 2009, and the agency will respond to all comments in a final rule issued no later than November 1, 2009. Unless otherwise specified, the new payment rates and policies will apply to services furnished to Medicare beneficiaries on or after January 1, 2010.
Crystalens HD Available in Quarter-Diopter Steps
Bausch & Lomb (Rochester, NY) received FDA approval to market the Crystalens HD in quarter-diopter steps in the United States and Europe. Quarter diopters will be available for the models HD500 and HD520 in the ranges of 18.00 to 22.00 D. The availability of a wider range is expected by the end of 2010, according to a company news release. Bausch & Lomb reportedly began shipping the Crystalens HD in the additional dioptric steps in July.
Bepreve Recommended for FDA Approval
The Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the FDA recommended the approval of Bepreve (bepotastine besilate ophthalmic solution; Ista Pharmaceuticals, Inc., Irvine, CA) 1.5% for the treatment of ocular itching associated with allergic conjunctivitis. The committee voted unanimously in favor of approving the eye drop after reviewing comprehensive safety and efficacy data from Ista's clinical program. According to a news release, Ista expects the FDA to make a final decision on the approval of Bepreve by September 12, 2009.
Bascom Palmer Eye Institute Appoints Chairman
Eduardo C. Alfonso, MD, has been named chairman of the Bascom Palmer Eye Institute of the University of Miami School of Medicine. Dr. Alfonso succeeds Carmen Puliafito, MD, MBA, who is now dean of the Keck School of Medicine of the University of Southern California in Los Angeles.
"I am honored to lead this extraordinary organization that is known worldwide for its innovation and excellence," said Dr. Alfonso in a news release. "It is a privilege to work with Bascom Palmer's outstanding faculty and staff, who are committed each day to delivering exceptional patient care, cutting-edge research, and the finest ophthalmic education."
Dr. Alfonso specializes in corneal transplantation and is a world leader in implanting artificial corneas. In 2006, he documented an increase in the incidence of an aggressive form of fungal corneal infections related to the use of soft contact lenses. His findings led to a reduction of new infections around the world and triggered a recall of a popular contact lens solution. Dr. Alfonso received the AAO's Honor Award in 1993 and Senior Achievement Award in 2003.
Patient-Harvested Stem Cells Healed Damaged Corneas
A stem-cell transplantation procedure rehabilitated corneas damaged by limbal stem cell deficiency, according to the results of a small study conducted by researchers at the University of New South Wales, Sydney, Australia.1
The trial included three patients, one of whom was aniridic. The other two had extensive corneal damage resulting from multiple surgeries to remove ocular melanomas. The patients' own limbal or conjunctival stem cells were cultured on therapeutic contact lenses, which were then placed on the damaged corneas for 10 days. During this period, the cells recolonized the surface of the eyes. Follow-up ranged from 8 to 13 months.
BCVA significantly improved in all eyes within weeks of the procedure. A stable, transparent corneal epithelium was restored in each eye, and there was no recurrence of conjunctivalization or corneal vascularization. Patients reported significant improvements in their symptoms.
"The procedure is simple and cheap," said the lead author of the study, Nick Di Girolamo, PhD, in a news release. "Unlike other techniques, it requires no foreign human or animal products, only the patient's own serum, and is completely noninvasive. There is no suturing, there is no major operation. All that is involved is harvesting a minute amount—less than 1 mm—of tissue from the ocular surface."
Stable Myopic Correction Achieved With the ICL
Long-term clinical outcomes demonstrated that the Visian ICL (STAAR Surgical Company, Monrovia, CA) provided stable correction of moderate-to-high myopia.1
Kazutaka Kamiya, MD, PhD, of the University of Kitasato School of Medicine, Kanagawa, Japan, and colleagues evaluated 56 eyes of 34 patients implanted with the Visian ICL. Myopic refractive errors ranged from -4.00 to -15.25 D. Follow-up examinations were conducted at 1, 3, and 6 months and at 1, 2, and 4 years.
Four years after surgery, 44 eyes were within 0.50 D of the targeted correction, and 52 eyes were within 1.00 D. Based on these observations, the investigators stated that "the results were good in all measures of safety, efficacy, predictability, and stability for the correction of high myopia throughout the 4-year follow-up." They noted that the Visian ICL "may be a good alternative for the treatment of moderate to high myopia. [However,] careful observation for longer than 4 years is necessary to assess late-onset complications of this surgical technique."
Inflammation Increases Risk of Corneal Graft Rejection
A retrospective analysis revealed that patients with undetected inflammation caused by herpes simplex virus keratitis may be at increased risk of corneal transplant rejection after penetrating keratoplasty, according to a study in Ophthalmology.1
Researchers at the Kellogg Eye Center in Ann Arbor, Michigan, examined the corneal tissue removed during penetrating keratoplasty of 62 patients with herpes simplex virus keratitis and identified inflammatory biomarkers that might be linked to transplant rejection.
Although the disease had been inactive for 6 months before surgery in 81% of patients, histopathology revealed that 74% had active corneal inflammation associated with clinical neovascularization (P=.01); a total of 34% of these patients experienced allograft rejections. "Treating inflammation intensively before corneal transplant surgery would reduce the risk of rejection," the study's authors concluded.
Industry Updates
TearLab Corporation (formerly OccuLogix, Inc., San Diego, CA) announced that Chief Executive Officer, Eric Donsky is leaving the company to pursue other opportunities. Mr. Donsky's resignation is effective immediately, according to a company news release. Mr. Donsky founded OcuSense with Benjamin Sullivan, PhD, in 2003 and remained the chief executive officer through its merger with OccuLogix in October 2008. TearLab's board of directors has reportedly appointed its chairman, Elias Vamvakas, to serve as interim chief executive officer until a permanent replacement for Mr. Donsky is found.
In May, Henry M. Mitchell retired from Alcon Laboratories, Inc. (Fort Worth, TX). Mr. Mitchell has spent the past 21 years teaching phaco techniques to surgeons and technicians as a national surgical consultant. He began his career as an ophthalmic assistant at the Baylor College of Medicine in Houston in 1971. Mr. Mitchell was one of five people originally trained to operate the Cavitron/Kelman phacoemulsifer (model 7001; Cavitron Corporation, acquired by CooperVision [Lake Forest, CA] followed by Alcon Laboratories, Inc.). Mr. Mitchell is currently the president of Crestpoint Management Ltd. (St. Louis, MO). Ê
CORRECTION
On page 71 of our June 2009 edition, the LRI calculator (www.lricalculator.com) maintained by Abbott Medical Optics Inc. (Santa Ana, CA) was incorrectly identified as a toric IOL calculator. Cataract & Refractive Surgery Today regrets the error.
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