In the world of retina care, doctors today are looking at all of the challenges they face from fresh angles, from the potentially blinding conditions they treat to the efficient delivery of care. The result has been a burst of new approaches and techniques and the opening of new research avenues, notably in the area of age-related macular degeneration (AMD).

A variety of new technologies figure prominently into what we're now able to do. Higher resolution cameras and enhanced acquisition speeds are allowing us to gather real-time information regarding retinal and choroidal blood flow down to the capillary level. Improved optical systems, including adaptive optics, now permit the imaging of photoreceptors and retinal pigment epithelial cells. Optical tomography makes it possible for the clinician to view cross sections of the retina and adjacent structures in many conditions, including macular hole, melanoma and macular degeneration.

These capabilities will not only improve diagnostic accuracy but will also give us a better understanding of the disease process and the effects of treatment, ultimately leading to improvements in treatment and prevention protocols.

Advances in laser delivery have also been introduced, mainly along two lines. First, we're using Visudyne, the first FDA-approved ocular photodynamic therapy (PDT), as a sophisticated means of localizing the action of a drug to treat choroidal neovascularization (CNV) associated with AMD. And other photosensitive substances are under investigation, including Optrin (Alcon), Purlytin (Miravant) and AK-1003 Akorn.) Future PDT strategies are likely to include the activation of carriers, such as liposomes or binding molecules, that will release a drug when activated by a certain wavelength of light. Ultimately, this could be used to deliver not only drugs but genetic material or individual cells.

Second, we're using various components of the laser-tissue interaction more effectively. In the past, we've delivered heat energy fairly indiscriminately. But recently developed millipulse infrared lasers concentrate the exchange of heat to deeper layers of the choroid, thereby more efficiently occluding feeder vessels with minimal damage to overlying structures.

In another approach, infrared lasers are being used at lower intensities and longer durations to cause relatively small changes in tissue temperature that can have significant long-term effects on abnormal blood vessels in macular degeneration and melanomas. Furthermore, subthreshold lasers are being evaluated for their efficacy in modifying the course of drusen in dry macular degeneration. Continued refinement in laser technology and delivery will add significantly to our armamentarium of retinal treatments.

More new tools and techniques are on the way

New classes of pharmacologic agents coupled with improved delivery systems will also have great impact on the treatment of retinal disorders. In addition to Visudyne and the forthcoming photoactivated delivery systems already mentioned, other delivery systems, based on slow-release intraocular implants, are under investigation. The first of these has been used for fighting CMV retinitis, but future devices will allow the delivery of a host of agents, including anti-inflammatory drugs (Bausch & Lomb, Envision TD), antibiotics, other anti-viral agents and various growth factors and growth-factor inhibitors. A large number of inhibitors of neovascularization (InSite Vision, ISV-615) are being tested for use in the treatment of macular degeneration and proliferative diabetic retinopathy.

On yet another front, cell transplantation promises to provide hope for a variety of patients with retinal disorders that cause the loss of critical cellular components. Considerable research effort has been focused on transplanting photoreceptor cells and retinal pigment epithelial (RPE) cells. The major current obstacle seems to be the difficulty in getting these transplanted cells to assume normal morphology and function, as well as to form proper connections to adjacent cells. (It's like placing a bunch of computer chips in your broken computer and hoping that they somehow reconnect in the proper way.)

New research suggests that the surrounding milieu and extracellular matrix are crucial in forcing these cells to behave properly. Once the specific extracellular matrix components are discovered, significant advances in cell transplantation are likely to occur. Another promising area is stem cell transplantation. These cells show an enhanced tendency to assume normal function and alignment with surrounding cells.

Bert M. Glaser, M.D., Baltimore and Chevy Chase, Md.

A Closer Look

Let's take a closer look at recent developments, summarized for Ophthalmology Management by several experts:

Practice management. I believe that one of the most substantial changes in the way retina surgery is performed will be the increasing use of ambulatory surgical centers (ASCs). Patient care issues and the possibility of increased retinal reimbursement for ASC facilities will eventually drive care away from hospital-based facilities, much like cataract surgery.

I've helped develop retinal facilities in two ASCs in southeastern Massachusetts. These facilities provide the highest standard of care with the best equipment technology can offer, and still operate "in the black." All major retinal surgeries can be performed in these centers, offering patients the convenience of local care. In addition, I have the "home court advantage" with well-trained staff members who are facile with the nuances of retinal surgery.

The end result is superb care, delivered much more efficiently, in a friendly environment. Faster procedures and turnaround time give rise to more productive use of staff and facilities. I perform surgery during a portion of the day and then examine patients for the remainder. When these facilities are adjacent to the clinical space, as in my setting, the lack of down time further maximizes individual productivity. The surgeon, practice and especially the patient benefit.

Eddie F. Kadrmas, M.D., Ph.D., Plymouth and Dartmouth, Mass.

Improved sutureless posterior vitrectomy. As you know, repair of complicated eye conditions, such as advanced diabetic retinopathy or retinal detachment, sometimes requires posterior vitrectomy. The standard technique involves the creation of large conjuctival peritomies as well as three full-thickness sclerotomies placed over the region of the pars plana of the ciliary body. An infusion line with cannula is typically sutured into position through one of the sclerotomies, and the remaining two sclerotomies are used for the placement of intraocular instruments into the vitreous cavity. Scleral plugs are typically employed to occlude the 20-gauge sclerotomies, and absorbable or nonabsorbable sutures are required to close these wounds as well as the overlying conjunctiva.

In 1996, the creation of sutureless pars plana scleral tunnel sclerotomies in pseudophakic and aphakic eyes was first described (Chen. Arch Ophthalmol. 1996; 114:1273-1275). Modifications of this method have allowed this technique to be employed in a variety of cases. Although the self-sealing scleral tunnel sclerotomies are somewhat more difficult to construct and are more problematic in eyes with thin sclera, the advantages are numerous. Manipulation of scleral plugs becomes unnecessary. Herniation of retina into the sclerotomies is eliminated. Variations in intraocular pressure by the sudden removal of the scleral plugs is reduced. The sclerotomies are typically self-sealing, requiring no sutures to close.

Additional modifications further enhance the usefulness of the sutureless technique. First, using a self-retaining infusion cannula (such as the Weiss self-retaining infusion cannula from DORC instruments) allows rapid infusion cannula insertion and removal, without sutures. This sutureless infusion cannula makes this technique especially safe and convenient in phakic eyes.

Also, the surgeon can move the cannula from one sclerotomy location to another with little effort. The infusion line can even be temporarily removed easily and quickly for certain portions of the procedure, such as scleral buckle placement or cryotherapy, where the infusion line can become an impediment. In aphakic or pseudophakic eyes, a standard 6-mm infusion cannula may be used without suturing. Retraction or suprachoroidal migration of the Weiss self-retaining infusion cannula or the
6-mm standard cannula is rare.

Second, use of miniature conjunctival peritomies allows abandonment of conjunctival sutures in cases not involving concomitant scleral buckle placement. The 5-mm peritomies are created anterior to the associated sclerotomy. At the end of the procedure, the conjunctiva, which was retracted posteriorly to allow creation of the posterior aspect of the sclerotomy, is repositioned anteriorly and secured with bipolar cautery.

This allows for a secure and completely sutureless closure in most cases. No significant differences in post-op intraocular pressure rises, post-op intravitreal gas fills, or problems with subconjunctival gas or silicone oil migration are encountered when compared with the standard technique.

Finally, use of topical anesthesia with sub-Tenon's supplementation provides additional advantages. Complications of retrobulbar hemorrhage or globe perforation are nearly eliminated. Also, the anesthesiologist is freer to use narcotic pain medications and avoid intravenous agents, such as methohexital sodium (Brevital Sodium) or propofol (Diprivan), which can cause some patients to become agitated and uncooperative for a period of time. I typically have the anesthesiologist administer midazolam (Versed) and fentanyl (Duragesic), which work well together for most patients.

The primary advantages of the sutureless posterior vitrectomy surgery technique (with the three modifications described herein) are operative speed and patient comfort. Many vitrectomy procedures can be completed in significantly less time. Upon completion of the intraocular maneuvers, the surgeon can quickly remove the instruments and infusion line, and close the three small conjunctival peritomies with bipolar cautery. Patients often require less intravenous sedation because the procedure is shorter, and they note their postoperative discomfort to be less than with the standard sutured technique.

The sutureless vitrectomy technique does have a few shortcomings. For example, the introduction and removal of some instruments, such as intraocular scissors and picks, can be more difficult. However, with experience this isn't problematic.

Extensive scleral depression or manipulation of the eye can make the sclerotomies less competent, although they usually retain their self-sealing capability. On those occasions when a sclerotomy isn't totally sealed, a single interrupted suture may be needed to completely close the scleral flap. This is especially noteworthy in re-operations. The sclerotomies are fairly easy to re-open with blunt dissection, and the entire technique can be used.

Intraocular advances in posterior vitrectomy surgery have expanded the indications and success of surgical intervention. The periocular advances of sutureless posterior vitrectomy surgery provide the additional benefits of improved operative speed and patient comfort.

Steven A. Boskovich, M.D., F.A.C.S, Flint, Mich.

Rolling over verteporfin during preparation for PDT. As I'll describe at the Vitreous Society conference this month, it's possible to use a rollover technique to save excess reconstituted verteporfin for use in cases of accidental spillage, reconstitution errors or with patients whose large body surface areas require more than one vial of the drug.

If you're treating multiple patients within a few hours of one another, prepare the injections by reconstituting the verteporfin with sterile water initially. Perform subsequent dilutions with 5% dextrose.

The total excess reconstituted verteporfin from the first preparation is used for the second preparation in addition to a portion of a new vial of verteporfin. The total excess reconstituted verteporfin from the second preparation is used for the third preparation in addition to a portion of a new vial. Repeat the technique for each subsequent reconstitution.

The excess remaining at any point can be used as long as the reconstituted verteporfin remains stable. (Verteporfin remains stable for 4 hours.)

Abdhish R. Bhavsar, M.D., Minneapolis, Minn.

BRVO update. Little has been available in the way of definitive treatments for branch retinal vein occlusions. Recently, however, investigators have shown that if the fibrous sheath surrounding the arterio-venous crossing at the point of the branch vein occlusion is surgically opened, blood flow and vision can be improved. In addition to allowing a new and promising treatment, these findings suggest that branch vein occlusion is a mechanical disorder caused by constriction of the fibrous sheath surrounding arterio-venous crossings of the retina. This knowledge may help in designing methods of prevention as well as treatment.

Bert M. Glaser, M.D., Chevy Chase and Baltimore, Md.

Needle-free anesthesia. The following approach eliminates the risk of sharp injections while providing excellent control during delicate maneuvers for patients under minimal or no sedation. I place Xylocaine jelly on the globe before or immediately after prepping the surgical field. This completely anesthetizes the conjunctiva during the initial incisions to expose the sclera. I insert a 21-gauge sub-Tenon's cannula (Katena) beneath Tenon's layer in two or three open quadrants. A total of 3 to 4 cc of anesthetic (2% xylocaine, 0.75% bupivacaine [Marcaine] and hyaluronidase [Wydase]) is infiltrated behind the globe. The anesthesia takes effect almost instantaneously, and the akinesia is complete by the time the sclerotomies are completed.

Needle-free sub-Tenon's anesthesia allows me to successfully manage primary and complex vitrectomies, scleral buckles and enhancements, without conventional sharp retrobulbar or peribulbar injections, facial nerve blocks, or general anesthesia. It enhances safety for me and my patients and is well-tolerated by the patients.

Jeffrey G. Gross, M.D., Columbia, S.C.

AMD research

As mentioned previously, several new avenues of research have opened in the drive against AMD. They include:

Prophylactic laser treatment. In the Prophylactic Treatment of Age-Related Macular Degeneration Trial (PTAMD), researchers are striving to determine the benefits of prophylactic laser treatment for the dry form of the disease.

Patients with five or more large soft drusen in both eyes are randomized as to which eye is treated prophylactically with a grid of 48 laser spots of such low intensity that the spots can't be seen during treatment. The subthreshold laser was selected on the basis of a large, randomized pilot study showing that when lower intensity laser spots are used, it may take longer for drusen resorption to occur, but the risks of choroidal neovascularization (CNV) associated with the treatment are reduced. Because several hundred thousand new cases of CNV are detected each year in the United States, a reduced incidence would be a major advance, and prophylactic treatment probably would be offered to many AMD patients.

�Thomas R. Friberg, M.D., Pittsburgh, Pa.

TTT. Transpupillary thermotherapy -- a large spot size, low irradiance, prolonged exposure (long-pulse), infrared laser photocoagulation protocol -- is being studied for use in treating occult CNV. Several clinical investigators from around the world have validated the results of a pilot study on TTT published in Ophthalmology last year. These results show that TTT is safe and appears to stabilize occult CNV effectively.

For example, in one study, at Kyorin University School of Medicine in Tokyo, 30 eyes with subfoveal CNV were treated according to a protocol that adjusted laser power to account for the pigmentation of Japanese eyes. Twenty of the treated eyes had occult wet AMD. Results for those 20 eyes at 8.75 months (mean) follow-up showed that visual acuity had improved in one eye, stabilized in 15 eyes and decreased in four eyes. Exudation was reduced in 15 eyes. The mean number of treatments per eye was 1.3. The authors wrote that a big advantage of TTT compared with conventional laser photocoagulation is that it doesn't cause immediate tissue necrosis.

Another study was presented by Dr. Richard Ahuja, University of Maryland, at the recent American Academy of Ophthalmology meeting in Dallas. Thirty-three eyes of 30 patients with occult subfoveal wet AMD were treated. Mean initial visual acuity was 20/400. After 10 months, visual acuity improved in five eyes, stabilized in 18 eyes and decreased in 10 eyes. Subretinal fluid resolved in 63% of eyes. Mean number of treatments required was 1.4.

The TTT4CNV Clinical Trial, a large, multicentered study, is ongoing; it compares TTT with sham treatment in a double-blinded manner. The trial is evaluating patients with early signs of CNV, specifically the occult form.

No proven treatment currently exists for occult CNV. Positive results from this trial would confirm the benefit of TTT in comparison to the natural history of occult CNV, and will emphasize the importance of early treatment of the early stages of exudative AMD.

TTT is a straightforward procedure, not taxing for elderly patients, and it's relatively inexpensive. And it allows the surgeon to monitor the progress of the procedure during treatment.

Elias Reichel, M.D., Boston, Mass.

Expanding the use of Visudyne. In December, a European Medicines Evaluation Agency committee announced that it recommended approval of Visudyne (verteporfin) for the treatment of patients with CNV caused by pathological myopia. The European Commission is expected to make a final decision regarding the expanded indication within the next few months.

In October, Novartis Ophthalmics and QLT PhotoTherapeutics had applied in Europe and the United States to expand the initial indication of Visudyne to other ocular conditions characterized by CNV, including pathological myopia, ocular histoplasmosis syndrome, angioid streaks and CNV due to certain retinal abnormalities.

Diane Donofrio Angelucci, contributing editor

Antiangiogenic agents. Revolutionary advances in our understanding of ocular neovascularization have led to the development of antiangiogenic therapies for AMD. Agents that affect vascular endothelial growth factor (VEGF) include a humanized monoclonal antibody fragment to VEGF 165 called rhuFab (Genentech). Enrollment for a Phase I-A clinical trial of the drug has been completed. A second anti-VEGF agent, the small molecule oligoneucleotide aptamer (EyeTech), which inhibits VEGF by a different mechanism, also completed enrollment for a Phase I-A study.

The angiostatic steroid anecortave (Alcon) inhibits neovascularization by mechanisms other than direct inhibition of VEGF and is being tested in a Phase II study. Trials also are anticipated for protein kinase C inhibitors, currently under investigation for diabetic retinopathy.

No pivotal Phase III trials have been performed with any of these agents. If they're safe and effective, they could significantly change the treatment of subfoveal neovascularization in AMD, particularly in the earliest stages or when other treatments can't be used.

Mark S. Blumenkranz, M.D., Stanford, Calif.

Intraocular prosthesis. Photoreceptor loss resulting from retinitis pigmentosa (RP) or AMD is a leading cause of retinal blindness. Because local pattern electrical stimulation of the retinas of blind patients with RP and AMD produced discrete, nonflickering visual percepts and form vision, researchers wanted to determine the feasibility of a chronic visual prosthesis.

During preliminary research, investigators concentrated on retinal electrical stimulation in normal or retinal degenerate animals, device development, and studying the histology of retinas from deceased patients who had RP. Results demonstrated the feasibility of implanting a chronic electrical prosthesis in animal models, and it is anticipated that patients with RP and AMD will benefit from this device in the near future.

�Mark S. Humayun, M.D., Ph.D., Eyal Margalit, M.D., Ph.D., and the Intraocular Prosthesis Group, Wilmer Ophthalmological Institute, Baltimore, Md.

Feeder vessel treatment. Feeder vessel treatment of intraocular neovascularization has been used for more than 25 years. However, detection of feeder vessels within the choroid has been limited by the rapid transit of dye and the presence of overlying pigment and blood. The recent development of high-speed ICG angiography (Heidelberg Engineering) has increased detection of choroidal feeder vessels to greater than 90% in cases of AMD, according to recent reports. These reports have also demonstrated that laser-induced closure of feeder vessels stabilizes or improves vision in the majority of cases. Newer millipulsed infrared lasers (from Iris) have assisted closure of choroidal feeder vessels by allowing deeper penetration of laser energy.

Bert M. Glaser, M.D., Chevy Chase and Baltimore, Md.

SnET2. As you know, PDT targets CNV associated with AMD, coupling infusion of a photosensitive drug with activation of the drug by a nonthermal laser to seal off leaking vessels. One drug being investigated is SnET2-Purlytin (Pharmacia, Miravant, Iridex). The Phase III study for SnET2 PDT for subfoveal choroidal neovascularization resulting from age-related maculopathy completed enrollment with 933 patients from 60 clinical centers in the United States in December 1999.

Two parallel, randomized, placebo-controlled, double-masked trials were conducted. All patients were required to have some component of classic neovascularization. Previous evaluation of the baseline demographic data demonstrated even distribution of parameters among the control, 0.50 mg/kg and 0.75 mg/kg dose groups. The 1-year data will be reviewed in the coming months. Efficacy data will be available this year.

Edgar L. Thomas, M.D., Beverly Hills, Calif.

Macular translocation. Macular translocation with scleral imbrication appears to have an important role in the management of certain cases of CNV associated with AMD and other disorders. In the October 2000 issue of the American Journal of Ophthalmology, we reported our results on 101 patients treated with translocation. Forty-eight percent of the patients had 20/100 or better vision by 6 months, and visual improvement of six or more lines occurred in 16% of patients. These remarkable results largely remain at 12 months, as we reported at the retina meeting held before the American Academy of Ophthalmology meeting in October 2000. (Patients with lesions that are 3.5 disk areas or smaller have a better chance of achieving "effective" translocation.) These results suggest that macular translocation can significantly improve vision.

Eugene De Juan, M.D., and Joseph E. Green, Baltimore, Md.

Refined macular translocation. Macular translocation has been used successfully in certain cases of AMD to move the macula away from the abnormal leaking choroidal blood vessels to an area of normal choroid. However, current surgical techniques employ infolding of the sclera, which can produce varied and unpredictable results. Investigators have developed a new surgical technique for macular translocation called scleral outpouching, that improves success dramatically. By folding the sclera away from the retina, the amount of translocation is significantly increased, resulting in greater and more predictable translocation of the macula. An article comparing prior techniques to outpouching was published in a recent issue of the American Journal of Ophthalmology.

Bert M. Glaser, M.D., Chevy Chase and Baltimore, Md.

Submacular surgery. A pilot study published in the October 2000 issue of the American Journal of Ophthalmology set out to determine whether 70 patients who had previous laser photocoagulation for extrafoveal or juxtafoveal CNV from AMD fared better with surgical removal or laser photocoagulation of recurring subfoveal lesions. Two years after treatment, visual acuity was better -- or no more that one line worse -- than baseline in 65% of eyes treated by laser photocoagulation, compared with 50% of eyes treated surgically. Lesion sizes and visual acuity changes were similar in both groups. Consequently, this pilot study showed that submacular surgery is not preferable to laser photocoagulation for CNV associated with AMD. However, the authors emphasized that a much larger group must be studied to obtain more meaningful results regarding visual acuity or complications.

Also, doctors involved in the Submacular Surgery Trial (SST) are comparing the results of surgical removal of subfoveal CNV to no treatment.

Diane Donofrio Angelucci, contributing editor

Rheotherapy. Rheotherapy, which involves membrane differential filtration, is being studied as a potential treatment for high-risk, semi-soft drusen. A Phase III, multicenter, prospective randomized, double-masked clinical trial is currently comparing this treatment with placebo. The trial is evaluating the efficacy and safety of the treatment using ETDRS acuity, Pepper Reading Score, and the NEI-VFQ score contrast sensitivity test. Patients between the ages of 50 and 85 with nonexudative large soft drusen, with ETDRS visual acuity between 20/32 and 20/125, receive four treatment sessions (each consisting of two treatments 2 days apart) given at 16-day intervals.

Patients receive a total of eight treatments over 2 months; they're evaluated 2 weeks after the final treatment and at 6, 9 and 12 months after baseline. If the treatment is found to be effective, patients with high-risk macromolecules (high cholesterol, high IgA, high fibrinogen) and semi-soft drusen may be treated with apheresis treatment.

David S. Boyer, M.D., Los Angeles, Calif.

Proton beam radiation. Data from a nonrandomized pilot study using the proton beam to deliver radiation for exudative AMD have been published in Eye (2000; 14:155-164). In the fourth year of follow-up, single-dose 8CGE (Cobalt Gray Equivalent) initially closed the new vessel complex, but regrowth began at 6 months, and recurrence was complete in all eyes after 2 years.

Because there was no toxicity in the 8CGE-treated eyes, we treated subsequent patients with 14CGE in a preplanned Phase I/II dose-escalation adjustment. Leakage decreased in nearly all lesions initially, and this response continued in 80% of eyes after 2 years follow-up. Research appears to show that 14CGE offers a longer-term effect on choroidal neovascular membrane growth than does 8CGE, with overall stabilization of visual function and growth inhibition.

Patients have developed radiation retinopathy over time, but severe visual loss has been limited. Based on the incidence of radiation retinopathy, adjustments in the total radiation dosage and/or fractionation of the dosage should be considered.

Christina Flaxel, M.D., Los Angeles, Calif., and Eric Friedrichsen, M.D., Fontana, Calif.

IPE transplantation. RPE cells can be damaged during surgical removal of the choroidal neovascular membrane in patients with AMD. Therefore, researchers in Germany conducted a study to determine whether transplanted autologous iris pigment epithelium (IPE) cells may be a viable alternative to autologous RPE cells in these patients.

During the study, which was published in the October 2000 issue of Archives of Ophthalmology, choroidal neovascular membranes were removed in 20 patients. Then, autologous IPE cells obtained by iridectomy were transplanted to the subretinal spaces. During the 6- to 11-month follow-up period, no immunologic response was detected, but three patients required additional surgery because of complications. Visual acuity improved or remained stable in 18 patients after the procedure. The authors believe their results suggest that autologous IPE cells may be used during transplantation rather than autologous RPE cells in patients with AMD.

Diane Donofrio Angelucci, contributing editor

Genetics. Many researchers suspect that genetics plays a role in AMD and that the disease may involve several genes. A study published in the August 2000 issue of the American Journal of Human Genetics provided additional evidence that ABCR alleles were linked to AMD in some patients.

In this study, researchers screened 1,218 patients with AMD and 1,258 controls. The two most frequent variants associated with AMD -- G1961E and D2177N -- were detected in an ABCR allele of 40 AMD patients, which was considered statistically significant. The variations were found in only 13 controls. The authors concluded that D2177N carriers are three times more likely and G1961E carriers are five times more likely to develop AMD.

Diane Donofrio Angelucci, contributing editor

OPT and TTT Reimbursement Update

By Donna M. McCune, COE, CCS-P, San Bernardino, Calif.

New treatment options for age-related macular degeneration (AMD) made for an exciting year for retina specialists. As information was made available to them, individual Medicare carriers and the Health Care Financing Administration (HCFA) established guidelines and reimbursement policies to address these promising new treatments. However, the evolving policies have left ophthalmologists with uncertainty and concern regarding claims submission and who is responsible for payment.

The Nov. 1, 2000 Federal Register, Calendar Year 2001 Physician Fee Schedule Policies and Payment, provides direction concerning these claims for 2001. Different policies apply to two new treatments, ocular photodynamic therapy (OPT) and transpupillary thermotherapy (TTT). Let's examine them separately:

�         OPT. In 2000, OPT was added to the description of CPT code 67220, destruction of localized lesion of choroid (e.g., choroidal neovascularization), one or more session, photocoagulation (e.g., laser, ocular photodynamic therapy). HCFA officials disputed the accuracy of 67220 as a description of OPT and suggested that a new CPT code was needed.
For 2001, a new CPT code has been established for OPT. 67221 appears in the 2001 CPT book. It's described as destruction of localized lesion of choroid (e.g., choroidal neovascularization); photodynamic therapy (includes intravenous infusion). CPT code 67220, destruction of localized lesion of choroid, will continue to be recognized, but not for OPT. The chart below shows the 2001 reimbursement details for these two CPT codes.

OPT and TTT Reimbursement Update

CPT Code	Non-facility RVU Total	Non-facility Reimbursement	Facility RVU	Facility Reimbursement	Post-op Days
67220	24.85	$950.71	23.69	$906.33	90
67221	8.91	$340.88	6.51	$249.06	0

Traditionally, when a service is performed bilaterally, the reimbursement for the fellow eye is either reimbursed at full value (100%) or reimbursed at half the allowed amount (50%). For OPT, a separate code was established to deal with both eyes treated on the same day. G0184, destruction of localized lesion of choroid (e.g., choroidal neovscularization); ocular photodynamic therapy (includes intravenous infusion) other eye, will be recognized as an add-on code for OPT of the second eye. The work and malpractice RVUs have been established and total 0.99 RVUs. The practice expense RVU hasn't been published; however, it will likely be small. We estimate reimbursement will be about $45. Modifiers RT (right eye) and LT (left eye) should be appended to 67221 and G0184 to provide additional information. The �50 modifier doesn't apply in this situation.
Effective July 18, 2000, verteporfin (Visudyne) was approved for inclusion in the U.S. Pharmacopoeia. This addition permits you to seek reimbursement for the drug in addition to the laser procedure. Your claim should include HCPCS code J3490, unclassified drug, and will be reimbursed at 95% of the Average Wholesale Price as defined in the Redbook. Note there is no additional reimbursement for the intravenous infusion of the drug (i.e., 90780).

�         TTT. The Nov. 1, 2000 Federal Register addresses TTT and two additional ophthalmic procedures: feeder vessel technique and destruction of macular drusen. Policy associated with these procedures continues to evolve. In the meantime, three HCPCS "G" codes have been established for them:

o       G0185, destruction of localized lesion of choroid (e.g., choroidal neovascularization); transpupillary thermotherapy, one or more sessions

o       G0186, destruction of localized lesion of choroid (e.g., choroidal neovascularization); photocoagulation, feeder vessel technique, one or more sessions

o       G0187, destruction of macular drusen, photocoagulation, one or more sessions.

The coverage and payment for these codes is at the discretion of each carrier. HCFA plans to review the frequency of procedures performed on Medicare beneficiaries. A national policy will be considered after sufficient Medicare experience with the procedure.

Cover all bases

In situations where coverage is ambiguous and unlikely, Medicare requires you to notify patients in writing of their financial responsibility prior to performing the procedure; otherwise Medicare waives the patient's liability for payment when your claim is denied. An Advanced Beneficiary Notice (ABN) or "waiver of liability" form satisfies this requirement. The ABN identifies the proposed procedure, why Medicare may deny the claim, and that the patient agrees to be financially responsible.

Several Medicare carriers have recently published local review policies for OPT. They describe indications, limitations, documentation requirements, and coding guidelines for 2000. We encourage you to seek guidance from your individual Medicare carrier for all the procedures described in this brief commentary.

Donna McCune is a senior reimbursement consultant with Corcoran Consulting Group. She has 14 years of experience in ophthalmology, including 12 years as an administrator in a busy medical/surgical ophthalmic practice in Connecticut.