title: Photodynamic therapy with verteporfin: observations on the introduction of a new treatment into clinical practice.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Department of Ophthalmology, Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, MD 21287-9019, USA. oschein@jhmi.edu
authors.forename: Oliver D
authors.initials: OD
authors.lastname: Schein
authors.forename: Neil M
authors.initials: NM
authors.lastname: Bressler
authors.forename: Patrick
authors.initials: P
authors.lastname: Price
mesh_terms: D020256:Choroidal Neovascularization / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D003362:Cost-Benefit Analysis; D003695:Delivery of Health Care; D017277:Drug Approval; D017723:Drug Utilization Review; D018588:Fee-for-Service Plans; D005451:Fluorescein Angiography; D019983:Guideline Adherence; D006279:Health Maintenance Organizations; D006302:Health Services Research; D006801:Humans; D008268:Macular Degeneration / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006278:Medicare; D010778:Photochemotherapy; D010781:Photography; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D011166:Porphyrins / Q000627:therapeutic use*; D017410:Practice Guidelines as Topic; D014481:United States; D014486:United States Food and Drug Administration; D000077362:Verteporfin
chemical_list: D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin