A study by the U.S. Preventive Services Task Force could prevent some private insurance coverage of glaucoma screening, due to what the task force says is a lack of data supporting certain aspects of the cost effectiveness of such screening. USPSTF is an advisory body that reports to the Agency for Health Care Research and Quality, the health-services research arm of the Department of Health and Human Services. USPSTF recommendations are not binding on federal agencies but may impact insurers' coverage decisions.
Experts in medicine, public health and government have roundly criticized the study's conclusions as inconsistent with the glaucoma screening benefit enacted in 2001 by Congress as part of Medicare, the policies of the Veterans Health Administration, the military health-care system, and the glaucoma screening measure implemented by the National Committee for Quality Assurance throughout the managed-care industry. It also seemingly contradicts decades of NIH-sponsored research and the stated policies of all professional societies that represent ophthalmologists and optometrists.
Hoping to counter the study, the Potomac Institute for Policy Studies and the Glaucoma Foundation last month sponsored a conference in
Former Secretary of Health & Human Services, Louis Sullivan, MD, told the conference that the USPSTF conclusions were "at odds with all recognized standards of care" and criticized the agency for failing to seek input from the National Institutes of Health, the Centers for Medicare & Medicaid Services or the Food and Drug Administration.
Ned Calonge, MD, MPH, the chair of USPSTF, countered that expert peer-review was provided, and suggested that the key conclusion under debate was not that glaucoma screening doesn't work, but that based on the principles of evidence-based medicine, there is not sufficient data to recommend for or against the practice of screening. A primary area of concern for his agency was its inability to find data linking the practice of screening to studies showing ultimate improvement in overall quality of life or vision-related quality of life, two key metrics in evidence-based medicine.
Several researchers reviewed data published since the initial USPSTF report that they hope will provide the linkage that USPSTF calls for. Among the studies cited are a re-analysis of the Los Angeles Latino Eye Study and other studies linking visual loss and the risk of falls in elderly patients.
U.S. Senator Norm Coleman, a member of the Senate's Special Committee on Aging, addressed the conference, saying he was "very disturbed" by the USPSTF report, and hopes that the "latest scientific information may be used to set the record straight" about the effectiveness of glaucoma screening. Emphasizing the need for preventive services, Sen. Coleman said, "Ninety-three percent of our health-care dollars are spent after a disease is diagnosed. We need to turn that around to impact lives and the federal budget. The glaucoma screening is a critical part of that mindset."
Service Stores Data for Refractive Surgery Patients
The problems of post-refractive surgery calculations of both intraocular lenses and intraocular pressure calculations have been known for many years. Numerous articles have described methods to estimate the true postop corneal power or methods to adjust the target IOL power following refractive surgery. Historical information, however, is often lost or not immediately available. An online record of what has been done to the eye and how it has changed would solve the problem of missing patient historical data. It would also give the surgeon the option of utilizing multiple published formulas.
Tampa
A patient record can be initiated in one of two ways. A patient can purchase a single account and request his or her medical record. The patient pays a one-time $30 fee to sign up for the service. The website creates an account for the patient and sends a welcome e-mail with the login name, password and a release of information form. The patient gives the release of information form to the refractive surgeon who performed the surgery. The data can then be recorded either by the patient or the physician.
Alternately, the service can be completely physician-driven. A refractive surgeon may elect to purchase bulk patient accounts at a discounted rate. The surgeon may then create patient records as needed. The refractive surgeon has the option to notify the patient by e-mail that he has been enrolled in the service. The database is designed to also store image files. Pre- and postop topographies, optic nerve head photos or visual fields can all be stored on the site for later reference.
The service is free to any physician to search the database for a specific patient. The ophthalmologist simply creates a free physician account, logs in and performs a search for the patient. If the patient is in the database, a request to the patient can be made through the website to give the physician access to the patient's record. Alternately, the patient could log into the website while at the physician's office, open his record and print it out on the spot. Currently it may take weeks for a response from the refractive surgeon for the records.
The website conforms to all HIPAA guidelines. The website has built-in safety features on the site. All connections with the website use an SSL (secure sockets layer), and all sensitive data is encrypted within the database. The data will also be backed up nightly to protect against loss.
"Ultimately this service is meant to give physicians easier access to medical records for a longer period of time," says Dr. Berger, who is president of the company. "Under some state laws, practices are only required to store information for five to seven years. Therefore when patients need access to their medical record 10, 20 or 30 years later, it is unavailable. The website records are guaranteed to be stored for a minimum of 30 years."
Safeguard Your Sight was exhibited for the first time last May at the ASCRS meeting. Dr. Berger reports that more than 180 physicians signed up for the service at the meeting. The company also will exhibit (booth 2631) at this month's
Ista Investigates Nasal Allergy Complement to Bepotastine
Ista Pharmaceuticals has licensed exclusive North American rights to nasal dosage forms of bepotastine, an investigational product for the treatment of allergy symptoms, from Tanabe Seiyaku Co.
Ista obtained exclusive North American rights to ophthalmic allergy applications of bepotastine and has been developing an ocular formulation of bepotastine to treat the symptoms of ocular itching. Following the previously announced positive Phase II/III clinical results the company received with its ocular formulation, Ista decided to add nasal bepotastine to its pipeline.
"We determined that complementing our ophthalmic formulation with a nasal formulation of bepotastine would potentially allow patients to experience relief from both ocular and nasal allergy symptoms," said Vicente Anido Jr., president and CEO of Ista. "We will look to maximize the value of our assets beyond the non-ophthalmic community by exploring options to work with others to expand our sales reach. However, it is our intention that Ista will remain committed to the ophthalmologist and retain our ophthalmic specialist focus."
The company anticipates completing the formulation of nasal bepotastine in 2008 and entering into clinical development in late 2008 or early 2009. Bepotastine has three primary mechanisms of action. It is a non-sedating, selective antagonist of the histamine 1 receptor, it has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues.
