View Public Comments for Ocular Photodynamic Therapy (OPT) with Verteporfin for Macular Degeneration

The American Society of Retina Specialists (ASRS) is pleased to be able to provide comments to CMS concerning the proposed revision or rescission of the Visudyne National Coverage Decision (NCD). We support and echo the comments and concerns expressed by the American Academy of Ophthalmology relative to the outdated nature of the current Visudyne NCD. Our membership has concerns about the current requirements in this NCD as they no longer reflect the current treatment practices nor do they allow for the current standards of care. We agree with the AAO’s comment that the change to this NCD in no way means that the treatment is no longer warranted, and we also believe that all Medicare Administrative Contractors will continue coverage of this service as well as the accompanying pharmaceutical required.

As you may be aware, the treatment of exudative age-related macular degeneration (wet-AMD) has changed dramatically over the past six years, as has the diagnostic tools available to us. While Ocular photodynamic therapy with verteporfin remains a viable treatment for some second-line wet-AMD patients and other patients with associated retinal diseases, the standard for monitoring the treatment of these patients has changed significantly. The use of optical coherence tomography (OCT) is now the standard imaging modality used to follow the disease and to make treatment choices. The use of fluorescein angiography as a tool to make treatment decisions is outdated and it provides less information to retina specialists about the status of the disease. The use of FA as required by this NCD no longer provides the beneficiary or physician with the most quantitative information from which to make a decision. The use of OCT is also more compelling in terms of treating the disease instead of a particular lesion “type” which is no longer consistent with how wet-AMD is viewed or classified.

Our members are also concerned about potential issues and liabilities which may exist as a result of the incompatibility between current best practices and this NCD’s requirements. As Medicare recovery audits have become more commonplace, we would like to help ensure that coverage policies meet the needs of your beneficiaries and reflect the current standards as practiced by our members and that they can follow best practices without the fear of subsequent reprisal.

We thank CMS for allowing us to comment on this NCD, and we look forward to providing any further comments that the agency may find useful.

Sincerely,

As a practicing vitreoretinal surgeon, I use OPT for subsets of patients with wet-ARMD including those who have failed anti-VEGF treatment. While fluorescein angiography is beneficial to analyze these patients on presentation, there is no longer a need for a mandatory 30 day window. Many of these patients do not have significant changes in their fluorescein angiographic images over time and therefore the requirement for another invasive test prior to treatment becomes superfluous.

As the current time, I perform verteporfin OPT for central serous chorioretinopathy as, or more frequently than for wet ARMD. OPT is the best treatment available for central serous chorioretinopathy with far fewer side effects than seen when treating wet ARMD. There are many small case series detailing the successful treatment of central serous chorioretinopathy with OPT, however the infrequency of this disorder and relative scarcity of insurance coverage hinders a large scale study. The FDA labeling for OPT with Verteporfin should be expanded to include central serous chorioretinopathy.

The American Academy of Ophthalmology, the Academy, is the world’s largest association of eye physicians and surgeons—Eye M.D.s—with 22,000 members in the United States. At our request, CMS has agreed to reopen this coverage policy to consider whether or not it should be rescinded. This NCD in is more than eight years old and no longer represent the current standard of care as the first line treatment for exudative age-related macular degeneration (wet-AMD) as there have been substantial advances in care for this chronic blinding disease. Ocular photodynamic therapy with verteporfin remains a viable treatment for end-stage wet-AMD but the standard for monitoring the treatment of these patients has changed. Rescission of a NCD in no way means that the treatment is no longer warranted and we are confident that all Medicare carriers will continue coverage of this service as well as the accompanying pharmaceutical required.

In 2004 OPT was the only FDA approved treatment for the blinding consequences of neovascular wet-AMD. Today, intravitreal injection of anti-VEGF drugs is the standard of care for the hundreds of thousands of Americans facing vision loss from AMD. Now, OPT and verteporfin, are considered an adjunctive therapy with anti-VEGF drugs are rarely used as primary monotherapy. This is demonstrated by Medicare claims data for utilization of OPT which is reported with CPT Code 67221 Destruction of localized lesion of choroid (eg, choroidal neovascularization); photodynamic therapy (includes intravenous infusion) which has decreased tenfold since 2001 when it was billed more than 84,300 times in the Medicare population, declining to 8500 times in 2011.

When the NCD was written back in 2004, an initial fluorescein angiogram was obtained to determine if the neovascular lesions were consistent with the angiographic features studied in clinical trials. Then, subsequent fluorescein angiography was necessary to determine if additional treatment was necessary. Today, optical coherence tomography (OCT) is the imaging modality of choice to determine the need for additional treatment. The use of OCT provides better information on disease activity and is more objective and quantitative for such decision-making than fluorescein angiography. Importantly, OCT is also noninvasive and therefore safer than fluorescein angiography. OPT is now typically used in an effort to decrease the frequency of anti-VEGF injections and therefore, when effective, presents an opportunity for significant cost reduction compared to continued monthly injections. A policy that requires a fluorescein angiogram within 30 days prior to OPT forces ophthalmologists to perform a test that may not be needed to provide optimal care.

It has recently come to the attention of the American Academy of Ophthalmology that ophthalmologists have been sent review notification letters referencing overpayments based on the above referenced NCD. Given the evolution of treatment and the many advances that we have seen for the treatment of wet-AMD, it is unfortunate and unfair that many retina physicians are being targeted under the RAC determinations brought forth under this outdated NCD and for that reason we requested that it be rescinded. We have previously provided substantial literature to support how OPDT is now provided and we hope that CMS will agree that it is time to retire this policy.

If you have any questions or need additional information, please contact us so that we can continue this important dialogue.

I would like to support the request submitted by Dr. Repka. The use of fluorescein angiography has changed significantly since the introduction of intravitreal anti-VEGF drugs. Patients who now are given PDT do not have fresh or treatment-naive lesions, and the angiographic appearance of these lesions is not very useful in many cases. The use of angiography should be left to the judgement of the treating physician, and not be required. The appearance of the lesion should not be used as a limiting factor in judging the appropriateness of the use of PDT in these patients. The use of PDT is now usually a salvage treatment. It often allows for at least a temporary increase in the interval between anti-VEGF injections, and often reduces the total cost of the patient's treatment plan. Thank you.