title: Economic outcomes among Medicare patients receiving bioengineered cellular technologies for treatment of diabetic foot ulcers.
abstract: OBJECTIVE
  To assess the real-world medical services utilization and associated costs of Medicare patients with diabetic foot ulcers (DFUs) treated with Apligraf (bioengineered living cellular construct (BLCC)) or Dermagraft (human fibroblast-derived dermal substitute (HFDS)) compared with those receiving conventional care (CC).
  
  
  METHODS
  DFU patients were selected from Medicare de-identified administrative claims using ICD-9-CM codes. The analysis followed an 'intent-to-treat' design, with cohorts assigned based on use of (1) BLCC, (2) HFDS, or (3) CC (i.e., ≥1 claim for a DFU-related treatment procedure or podiatrist visit and no evidence of skin substitute use) for treatment of DFU in 2006-2012. Propensity score models were used to separately match BLCC and HFDS patients to CC patients with similar baseline demographics, wound severity, and physician experience measures. Medical resource use, lower-limb amputation rates, and total healthcare costs (2012 USD; from payer perspective) during the 18 months following treatment initiation were compared among the resulting matched samples.
  
  
  RESULTS
  Data for 502 matched BLCC-CC patient pairs and 222 matched HFDS-CC patient pairs were analyzed. Increased costs associated with outpatient service utilization relative to matched CC patients were offset by lower amputation rates (-27.6% BLCC, -22.2% HFDS), fewer days hospitalized (-33.3% BLCC, -42.4% HFDS), and fewer emergency department visits (-32.3% BLCC, -25.7% HFDS) among BLCC/HFDS patients. Consequently, BLCC and HFDS patients had per-patient average healthcare costs during the 18-month follow-up period that were lower than their respective matched CC counterparts (-$5253 BLCC, -$6991 HFDS).
  
  
  CONCLUSIONS
  Findings relied on accuracy of diagnosis and procedure codes contained in the claims data, and did not account for outcomes and costs beyond 18 months after treatment initiation.
  
  
  CONCLUSIONS
  These findings suggest that use of BLCC and HFDS for treatment of DFU may lower overall medical costs through reduced utilization of costly healthcare services.
authors: a a Analysis Group, Inc. , Boston , MA , USA.
authors: J Bradford
authors: JB
authors: Rice
authors: a a Analysis Group, Inc. , Boston , MA , USA.
authors: Urvi
authors: U
authors: Desai
authors: a a Analysis Group, Inc. , Boston , MA , USA.
authors: Ljubica
authors: L
authors: Ristovska
authors: a a Analysis Group, Inc. , Boston , MA , USA.
authors: Alice Kate G
authors: AK
authors: Cummings
authors: a a Analysis Group, Inc. , Boston , MA , USA.
authors: Howard G
authors: HG
authors: Birnbaum
authors: b b Organogenesis, Inc. , Canton , MA , USA.
authors: Michelle
authors: M
authors: Skornicki
authors: c c Perelman School of Medicine, University of Pennsylvania , Philadelphia , PA , USA.
authors: David J
authors: DJ
authors: Margolis
authors: b b Organogenesis, Inc. , Canton , MA , USA.
authors: Nathan B
authors: NB
authors: Parsons
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical / Q000191:economics / Q000706:statistics & numerical data; D020099:Coated Materials, Biocompatible / Q000191:economics*; D003094:Collagen / Q000191:economics*; D015897:Comorbidity; D017719:Diabetic Foot / Q000191:economics* / Q000628:therapy*; D005260:Female; D005102:Health Expenditures; D006296:Health Services / Q000706:statistics & numerical data; D006801:Humans; D007345:Insurance Claim Review / Q000706:statistics & numerical data; D008297:Male; D006278:Medicare / Q000706:statistics & numerical data; D057216:Propensity Score; D012737:Sex Factors; D017768:Skin, Artificial / Q000191:economics*; D012959:Socioeconomic Factors; D015599:Trauma Severity Indices; D014481:United States; D014945:Wound Healing
chemical_list: C117898:Apligraf; D020099:Coated Materials, Biocompatible; C512800:TransCyte; D003094:Collagen
keywords: Advanced wound care; Bioengineered cellular technologies; Cost-effectiveness; Diabetic foot ulcers