October 2014- New Location!
We are pleased to announce the expansion of our practice to Northern Virginia with the establishment of an office location in Vienna beginning in October 2014. The address is: 407 Church Street, NE Suite E Vienna, VA 22180. We can be reached via phone: 703-255-2230 or fax: 703-255-2238. We look forward to this new opportunity to serve the Northern Virginia region and in continuing to provide excellent, highly personalized retinal care.
The following Statement was released by the American Society of Retina Specialists in response to the Centers for Medicare and Medicaid Services’ decision to release Consultant payment data.
The American Society of Retina Specialists (ASRS) Cautions Patients Against Making Treatment Decisions Based Solely On Consultant Payment Data
April 10, 2014- The American Society of Retina Specialists (ASRS) supports the Centers for Medicare and Medicaid Services’ (CMS) efforts to make the Medicare program more patient-centered, transparent and competitive. We believe, however, releasing physician payment data without adequate tools to interpret it has the potential of misleading patients into making inappropriate and potentially harmful treatment decisions. At the very least, patients need to receive information about fixed costs of care, particularly Medicare Part B covered drug costs. In the case of retina specialists, these drugs are essential for treating patients with retinal diseases and preventing blindness.
Retina specialists effective utilize highly advanced, sophisticated technology for diagnostic testing and treatment and use expensive pharmacologic agents. Because the reimbursement data will not reflect the substantial expenses associated with operating a retina specialist clinic, ASRS is concerned that the claims data alone will offer a distorted view of the revenue generated by retina specialist practices. To fully appreciated the costs of care, patients need guidance on how to interpret the data to take into account the fixed cost of care, such as Medicare Part B drugs and imaging equipment, as well as patient demographics and the complexity of care. For example, retina specialists must purchase on behalf of the patient and then be paid by CMS for high-cost, FDA-approved anti-VEGF drugs used to treat wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion and diabetic macular edema (DME).
Patient factors also must be taken into consideration. The complexity of the typical diabetic patient seen by a retina specialist will be greater than the typical diabetic patient seen by a general ophthalmologist, so utilization of imaging such as optical coherence tomography, as well as laser treatments and other costly services, will be justifiably higher.
It requires more information than is being released by CMS to compare the cost of a retina specialist treating diabetic retinopathy in an affluent suburb, where patients have reasonably good glucose control, with the cost of another retina specialist who practices in a predominantly lower-income, urban locale where patients have poor glucose control and many missed appointments.
The American Society of Retina Specialists is the premier international medical society for ophthalmologists who have completed a retinal fellowship, with more than 2,500 members. The mission of the ASRS is to provide a collegial, open forum for education, to advance the understanding and treatment of vitreoretinal diseases, and to enhance the ability of its members to provide the highest quality of patient care.
Clinical Specialties Compounding Pharmacy Issues Voluntary Nationwide Recall of Avastin
Clinical Specialties, a compounding pharmacy located in Augusta GA, has issued a voluntary nationwide recall of Avastin unit dose syringes due to the potential risk of serious eye infection. The recalled syringes were distributed to doctor’s offices in Georgia, Louisiana, South Carolina, and Indiana from October 19, 2012 to March 19, 2013. The following statement was released by the FDA in response to this recall.
FOR IMMEDIATE RELEASE – March 20, 2013 – Clinical Specialties is voluntarily recalling All Lots of All Sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products. The expanded recall follows the firm’s initial recall of Avastin due to reports of five patients who have been diagnosed with serious eye infections
associated with the use of the product. Although there has been no evidence of contamination with sterile products other than the specified Avastin lots, Clinical Specialties has decided in the interest of their patients to proceed with this recall process.
The Center for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections, which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. Clinical Specialties Compounding repackaged the Avastin into individual single-use syringes from the manufactured vials labeled as sterile. A compromised sterile product puts patients at risk for serious and possible life threatening infection.
Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013. Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company.
Consumers or Health Care providers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915 or e-mail address at firstname.lastname@example.org; Monday through Friday between the hours of 10 am to 5 pm EST. Patients who have received any product distributed by Clinical Specialties Compounding and have concerns should contact their healthcare provider. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
We, at Center For Retinal Diseases and Surgery (CRDS) want to assure you that Clinical Specialties Compounding Pharmacy does not supply any of the drugs we use in this practice. As we have mentioned elsewhere in our updates, we are very confident about the quality and sterility of the drugs we receive from our supplier, Leiter’s Pharmacy. Please feel free to contact us if you have any questions regarding your Avastin treatment.
New Drug approved for the treatment of Vitreomacular Adhesion
U.S. FDA Approves ThromboGenics’ JETREA® (Ocriplasmin) for the Treatment of Symptomatic Vitreomacular Adhesion (VMA). This new drug will not be available for patients until early 2013.
Compounded Avastin Injections
Due to the recent outbreak of fungal meningitis that has been linked to tainted steroid injections prepared by New England Compounding Center, we thought it necessary to provide information on where we obtain our supply of compounded Avastin injections. We would like to assure you that we do not use New England Compounding Center for any of the drugs we use in the office. We use a compounding center named Leiter’s Pharmacy, which is located in San Jose, CA. Leiter’s Pharmacy is one of the few compounding pharmacies in the United States that is accredited by the Pharmacy Compounding Accreditation Board (PCAB). Information regarding this entity can be found on their website: pcab.org
Leiter’s pharmacy uses an independent lab for testing of all Avastin injections that they compound, and they quarantine all lots of Avastin until this testing is complete. This testing includes screens for Gram Negative Bacteria, Gram Positive Bacteria, yeast, and mold. Once the testing is complete, Leiter’s sends us our Avastin order, along with a copy of the lab report verifying the sterility of the drug. Leiter’s pharmacy has distributed over 600,000 syringes of Avastin to date, without incident.
While we feel very confident about the quality and sterility of the Avastin injections we receive from Leiter’s, we understand that you still may have some questions concerning this drug since it is compounded. If you have any questions or concerns about your treatment, or if you would like to discuss alternative drug therapies, please feel free to do so with Dr. Pappas, Jr. at or before your next visit.
New Indication for Lucentis® (ranibizumab injection)
Lucentis® (ranibizumab injection) 0.3 mg per month dosing is now FDA-approved for the treatment of adult patients with diabetic macular edema (DME). This drug is currently available in our office for treatment of all on-label indications including neovascular (wet) age-related macular degeneration (AMD), macular edema secondary to retinal vein occlusion (RVO), and diabetic macular edema (DME).