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  Vol. 123 No. 1, January 2005 TABLE OF CONTENTS
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Photodynamic Therapy With Verteporfin

Observations on the Introduction of a New Treatment Into Clinical Practice

Oliver D. Schein, MD, MPH; Neil M. Bressler, MD; Patrick Price, MD

Arch Ophthalmol. 2005;123:58-63.

Objective  To assess adherence to Food and Drug Administration–approved indications and Centers for Medicare & Medicaid Services policy through June 2001 regarding the use of photodynamic therapy in Medicare beneficiaries.

Design  Systematic review of pretreatment fluorescein angiograms of 1245 consecutive Medicare patients who received photodynamic therapy from physicians in 3 contiguous Medicare coverage areas (fee-for-service arrangement) and in 136 consecutive patients in a Medicare health maintenance organization.

Results  In the 3 Medicare fee-for-service regions, payment denial due to nonconforming fluorescein angiograms ranged from 17% to 29% by region in 1245 beneficiaries. In the health maintenance organization setting, 60 (44%) of 136 submitted angiograms were nonconforming, including 8 in which the photographic quality was too poor to grade the lesion size, composition, or both.

Conclusions  A substantial proportion of the actual or intended clinical application of photodynamic therapy with verteporfin was directed to patients who did not meet concurrent published clinical criteria associated with treatment benefit or national coverage policy. Although this policy has evolved, it still depends on fluorescein angiographic interpretation, suggesting that there is an opportunity to improve the cost-effectiveness of delivery of photodynamic therapy with verteporfin to Medicare beneficiaries.


Author Affiliations: Department of Ophthalmology, Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Md (Drs Schein and Bressler); and Blue Cross and Blue Shield of Kansas, Topeka (Dr Price).







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