Patient Management in Intravitreal Injections

JOSEPH M. CONEY, MD, & LAWRENCE J. SINGERMAN, MD, FACS

In recent years, administration of intravitreal injections (IVIs) has increased dramatically.With the variety of new medications and treatment options available, these injections are rapidly becoming a mainstream treatment for retinal diseases. As the population ages and retinal vascular diseases become more prevalent, multiple IVIs are required to treat chronic and progressive diseases. Correspondingly, as the number of IVIs increase, so do the challenges for many large, high-volume practices that administer hundreds of injections each week. Some of these challenges include: (1) defined clinic policies and procedures, including safety guidelines for drug administration and consent forms; (2) follow-up care; (3) staffing; (4) proper training and knowledge; (5) adequate space for patient flow; (6) appropriate scheduling; (7) drug inventories; and (8) reimbursement issues.

HIGH-VOLUME PRACTICE
Our practice, Retina Associates of Cleveland, Inc. (RACI), performed over 5000 IVIs in 2006. RACI’s 7 retina specialists cover 9 offices in northern Ohio and western Pennsylvania. RACI had to find solutions for the increasing trend toward IVI. The practice employs over 100 professional staff. Three of the offices are site centers for over 30 national clinical trials that require the use of IVIs of treatments such as pegaptanib sodium (Macugen, [OSI] Eyetech/Pfizer), triamcinolone acetonide (Kenalog, Bristol-Myers Squibb), ranibizumab (Lucentis, Genentech), bevacizumab (Avastin, Genentech), and dexamethasone implant (Posurdex, Allergan). Our participation in these studies and in clinical trials of other medical and surgical therapies provides our patients with the opportunity to have cutting-edge treatment at no cost to them.
Although each clinical trial has a set protocol for the administration of the IVI, all require the procedure to be done under sterile conditions. RACI established a uniform procedural policy for the administration of all IVI. An instrument packet — containing a sterile caliper, speculum, gloves, DuoDERM lid tape (ConvaTec, Princeton, NJ), 5 or 6 sterile applicators, 4% lidocaine, povidone-iodine solution, and topical antibiotic drops with a sterile field — are prepackaged. The packages are stored in a primary injection room to maximize efficiency in preparing the patient for their injections.

PATIENT EDUCATION
We developed consent forms that cover the potential risks and complications associated with the injections. If the injection is to be done on another day, the patient is given a consent form to take home, along with a sample of topical antibiotic to be used for 3 days before the appointment for the injection. This allows the patient adequate time to review all the material, to think about the IVI, and to discuss the decision with family members.We also use this approach so that the patient does not feel pressured about the procedure. For many individuals, the initial injection can be a “hard sell,” and the extra time is often helpful.
RACI created discharge instructions and other patient education materials to facilitate management of patient expectations and concerns. A brief description of the procedure is included with a list of the most common side effects. It is stressed that, if the symptoms do not lessen, the patient should call the office as soon as possible and ask to speak to a technician. Complications of IVI are rare but require immediate attention by a physician. Problems that necessitate prompt evaluation include worsening eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, increased sensitivity to light, or an increased number of floaters.

THE IMPORTANCE OF STAFF
Of utmost importance is having a well-trained and well-educated staff. The staff must engage in continued education regarding the new protocols. RACI has several surgical assistants, physician assistants, and registered nurses to help set up and assist with the injections. Their clinical training is often more extensive than that of the ophthalmic technicians; however, a well-trained, responsible technician is all that is truly needed. The entire staff is educated on the policy and procedure for IVIs. A specific technician is assigned to a procedure room and has the responsibility of preparing the patient for an IVI.
The RACI physicians had performed intravitreal triamcinolone injections before the introduction of other drugs such as pegaptanib; therefore, the transition to IVI was relatively simple and did not require significant hands-on tutorial sessions for the staff. Patients are prepped in accordance with the sterile protocol before the physician sees the patient. To maximize patient care and efficiency, the most recent optical coherence tomography (OCT) and fluorescein angiography (FA) results are available for the physician to review on a computer monitor in the procedure room.

MODIFICATIONS TO THE PHYSICAL PLANT RACI
has seen a tremendous increase in IVIs, from 900 to over 5000 injections, in the period from 2004 through 2006. Such an increase can result in overcrowded and uncomfortable waiting rooms. One solution is to install electronic medical records to allow the records to be reallocated to a procedure/exam room. This will allow for expected increases in number of patients. RACI created a separate area for injections that also allows better patient flow. In addition to the primary injection room, a secondary injection room is available for use when the number of patients receiving injections is high. Also, patients are fasttracked, limiting the time spent in the office for patients and their families.
Maintaining the drug inventories is just as important as administrating the injection. RACI orders medications through Besse Medical (Cincinnati), CuraScript (Orlando, Fla), or compounding pharmacies. All offices have a small refrigerator dedicated to medications only. The refrigerators have electronic temperature alarms or manual high/low thermometers to monitor the internal temperatures so that the staff is aware if the refrigerator temperature is changing. The thermometers are checked daily.

INVENTORY AND INSURANCE
Overall, the provider schedule has not changed at RACI.We have opened new appointments that are allocated to the procedure room. Appointments are scheduled every 15 minutes for an injection. If a follow-up OCT or FA is needed, the physician asks that it be done before he sees the patient. All procedure rooms and exam rooms are equipped with high-resolution monitors to review photos with the patient in the office.
Daily inventory-tracking logs are kept at all locations to monitor drug arrival, distribution to patients, and transportation of drugs to other offices. Lead technicians at offices are assigned the responsibility of drug inventory. Drugs are not dispensed until the means of reimbursement for the drug is determined. Medications that are administered to patients are listed on the office surgical fee ticket. RACI can inventory medication by comparing the office logs, billing data, and the units of drugs in the offices with the quantity ordered.
Reimbursement for the injection and the medicine requires a dedicated and diligent staff. All insurance carriers are sent e-mails requesting a written response regarding payment policy on drug and procedure. A note is placed on the front of the chart if a patient needs precertification for an IVI. This helps the staff facilitate patient care, especially if an injection is needed that day. Patients whose treatment is not covered by insurance must identify a payer source and make payment prior to the procedure. The billing department checks procedure appointment logs and verifies the payer source 24 hours before the injection.
Some insurance companies do not cover certain drugs or the off-label use of a drug, such as the intravitreal use of bevacizumab. In these circumstances, we give the patient an Advance Beneficiary Notice (ABN) to sign before treatment. The purpose of the ABN is to inform the patient that the treatment may not be covered by insurance. It allows patients to make informed consumer decisions as to whether to agree to receive treatment that may need to be paid out-of-pocket.
If the patient agrees to the treatment and signs the ABN, a GA modifier is added to the appropriate procedure codes. GA modifiers indicate to the insurance companies that the patients are aware that they may be responsible for payment if the treatment is not covered.
We never withhold treatment because of a patient’s inability to pay. Many pharmaceutical companies have programs that provide medicines at no cost to patients who meet specific criteria.Our billing personnel and patient care staff work together to substantiate that the patient meets the financial and medical criteria for applying to these programs.

STAYING CURRENT RACI
has adapted to the changing demands in retinal medicine.We have found that a defined clinic policy/ procedure protocol maximizes efficiency and helps with patient flow. In addition, well-trained and knowledgeable personnel facilitate scheduling and staffing issues, and strict drug inventory control, in combination with an efficient billing department, maximizes reimbursements. By combining clinical research and patient care, we have been able to make the necessary adjustments to meet the clinical demands of IVI administration and maintain a high level of commitment to the care of our patients.

Joseph M. Coney, MD, and Lawrence J. Singerman, MD, FACS, are partners at Retina Associates of Cleveland, Inc. Their group has received grant support to perform clinical trials evaluating pegaptanib, ranibizumab, and the dexamethasone implant Posurdex. Dr. Singerman is on Eyetech’s Scientific Advisory Board and has presented the results of Macugen clinical trials at scientific meetings.