PEDIATRIC/CRANIOFACIAL A Comparative Cost Analysis of Cleft Lip Adhesion and Nasoalveolar Molding before Formal Cleft Lip Repair Paul L. Shay, B.A. Jesse A. Goldstein, M.D. J. Thomas Paliga, B.A. Jason Wink, B.A. Oksana A. Jackson, M.D. David Low, M.D. Scott P. Bartlett, M.D. Jesse A. Taylor, M.D. Philadelphia, Pa.
Background: Patients with complete cleft lip and palate may benefit from cleft lip adhesion or nasoalveolar molding before formal cleft lip repair. The authors compared the relative costs to insurers of these two treatment modalities and the burden of care to families. Methods: A retrospective analysis was performed of cleft lip and palate patients treated with nasoalveolar molding or cleft lip adhesion at The Children’s Hospital of Philadelphia between January of 2007 and June of 2012. Demographic, appointment, and surgical data were reviewed; surgical, inpatient hospital, and orthodontic charges and costs were obtained. Multivariate linear regression and two-sample, two-tailed independent t tests were performed to compare cost and appointment data between groups. Results: Forty-two cleft adhesion and 35 nasoalveolar molding patients met inclusion criteria. Mean costs for nasoalveolar molding were $3550.24 ± $667.27. Cleft adhesion costs, consisting of both hospital and surgical costs, were $9370.55 ± $1691.79. Analysis of log costs demonstrated a significant difference between the groups, with the mean total cost for nasoalveolar molding significantly lower than that for adhesion (p < 0.0001). Nasoalveolar molding patients had significantly more made, cancelled, no-show, and missed visits and a higher missed percentage than adhesion patients (p < 0.0001) for all except no-show appointments, (p = 0.0199), indicating a higher burden of care to families. Conclusions: Nasoalveolar molding may cost less before formal cleft lip repair treatment than cleft lip adhesion. Third-party payers who cover adhesion and not nasoalveolar molding may not be acting in their own best interest. Nasoalveolar molding places a higher burden of care on families, and this fact should be considered in planning treatment. (Plast. Reconstr. Surg. 136: 1264, 2015.)
C
left lip and palate is the most common congenital craniofacial anomaly, occurring at an estimated rate of one in 600 live births in the United States.1 Patients with wide cleft lip and palate may benefit from surgical or orthodontic modalities to align alveolar segments, decrease cleft distances, and improve nasal contour before formal cleft lip repair. Both cleft lip adhesion and nasoalveolar molding can assist in accomplishing these anatomical goals to improve overall aesthetic outcomes after formal cleft lip repair. From the Division of Plastic Surgery, Perelman School of Medicine at the University of Pennsylvania, The Children’s Hospital of Philadelphia. Received for publication October 12, 2012; accepted March 19, 2013. Copyright © 2015 by the American Society of Plastic Surgeons DOI: 10.1097/PRS.0b013e31829b69fe
1264
Cleft lip adhesion is the older of the two treatments and was initially described by Dr. B. Johanson in 1961, who performed it incidentally as a part of a maxillary alveolar cleft repair.2 Dr. Peter Randall is credited with popularizing the technique after he published a larger study of cleft lip adhesion in 1965. He described converting complete clefts into incomplete clefts at 3.5 months of age, which allowed for a more effective formal cleft lip repair, performed 1.1 to 1.4 months later.3 Methods have evolved since 1965, and the treatment has proven to be efficacious4–7 (Fig. 1). New York orthodontist Dr. Barry H. Grayson first described nasoalveolar molding in 1993. An Disclosure: The authors have no conflicts of interest to disclose or financial disclosures to report.
www.PRSJournal.com
Copyright © 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.
Volume 136, Number 6 • Cost of Therapy before Cleft Lip Repair
Fig. 1. (Left) Patient presenting at 1 month of age with wide unilateral cleft lip and palate before cleft lip adhesion. (Right) Patient at 2.5 months of age immediately following cleft lip adhesion.
impression is made of the cleft lip and palate within the first week after birth. This impression is used to make a mold plate, which is then inserted intraorally and adjusted weekly to align the alveolar segments. This usually allows for formal cleft lip repair between 3 and 5 months of age.8 Longterm studies on nasoalveolar molding also have shown it to be efficacious9,10 (Fig. 2). There is, however, a paucity of literature comparing the cost of these treatment modalities. Historically, insurers have been willing to cover surgical methods such as cleft lip adhesion, but have been more reticent to cover orthodonticbased treatments such as nasoalveolar molding. Our goal was to perform a formal cost analysis of cleft lip adhesion and nasoalveolar molding treatment in patients with cleft lip and palate at a large cleft referral center to determine whether third-party payers are behaving rationally from a financial perspective. In addition, we sought to compare the relative burden of care for families as described by duration of treatment, and appointments made, missed, and cancelled.
PATIENTS AND METHODS Following review and approval by the Institutional Review Board of The Children’s Hospital of Philadelphia, a retrospective cost analysis was performed on patients with cleft lip and palate presenting to The Children’s Hospital of Philadelphia between January of 2007 and June of 2012. Those patients who underwent either cleft lip adhesion
or nasoalveolar molding treatment identified by Current Procedural Terminology and billing codes were included for evaluation. Decision for cleft lip adhesion or nasoalveolar molding was made based on family willingness to adhere to the multiple office visits required for molding treatment, ability to comply with therapy, and insurance preapproval. Exclusion criteria included syndromic diagnoses, incomplete patient records, incomplete financial records, and not having undergone a formal cleft lip repair at the time of data extraction. Charts were reviewed by means of electronic medical record for demographics, including sex, race, and Veau cleft type. An assessment of the burden of care posed by adhesion and nasoalveolar molding was performed as a function of (1) number of made and missed appointments before formal cleft lip repair and (2) complications. The two types of appointments that were included in this study were visits to either an orthodontist or an attending plastic surgeon at the Cleft Lip and Cleft Palate Program at The Children’s Hospital of Philadelphia. Timing of treatment and complications of treatment were also collected and compared by twosample, two-tailed independent t test. Surgical and orthodontic charges and payments (costs) were compiled for individual cleft lip adhesion and nasoalveolar molding patients through the Department of Surgery’s accounting department. All dollars were adjusted to 2012 dollars using the latest Consumer Price Index data from the U.S. Department of Labor Bureau of Labor Statistics.11 The Fisher’s exact test was used
1265 Copyright © 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.
Plastic and Reconstructive Surgery • December 2015
Fig. 2. (Above, left) Patient on initial evaluation at 1 month of age showing wide cleft before nasoalveolar molding treatment. (Above, right) Patient with nasoalveolar molding device in place. (Below, left) Intraoral view of the wide cleft palate in the patient at 1 month of age, before nasoalveolar molding treatment. (Below, right) Inferior view of the patient at 1 month of age, before nasoalveolar molding treatment.
to compare demographic information. Multivariate linear regression analysis was performed on the log cost to determine the significance of various dependent variables on financial data. Log costs were then retransformed based on the Duan smearing retransformation to obtain mean costs for differing treatment groups.12 Two-sample, twotailed, t tests were performed to compare appointment data between groups.
RESULTS Patients A total 87 patients were identified who underwent either cleft lip adhesion or nasoalveolar molding treatment at The Children’s Hospital of
Philadelphia between January of 2007 and June of 2012. Ten patients were excluded for the following reasons: five were syndromic, two had not yet undergone formal cleft lip repair at the time of data extraction, two had incomplete financial information, and one underwent both cleft lip adhesion surgery and nasoalveolar molding treatment before formal cleft lip repair. Thus, a total of 77 patients were included in the study. Thirtyfive patients underwent nasoalveolar molding treatment, and 42 patients underwent adhesion surgery. Complete demographic data are listed in Table 1. There were no significant differences between the two treatment groups in terms of sex, race/ethnicity, or Veau classification (p = 0.49, p = 0.93, and p = 0.80, respectively).
1266 Copyright © 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.
Volume 136, Number 6 • Cost of Therapy before Cleft Lip Repair Table 1. Nasoalveolar Molding versus Cleft Lip Adhesion Demographics No. of subjects* Sex Female Male Type of cleft Veau III Veau IV IUCL* IBCL† Race/ethnicity White Black/African American Asian Other Uninsured
NAM (%)
CLA (%)
35 (45.5)
42 (54.5)
13 (37.1) 22 (62.9)
20 (47.6) 22 (52.4)
21 (60.0) 9 (25.7) 4 (11.4) 1 (2.9)
29 (69.0) 7 (16.7) 5 (11.9) 1 (2.4)
25 (71.4) 5 (14.3) 2 (5.7) 3 (8.6) 2 (5.7)
27 (64.3) 7 (16.7) 3 (7.1) 5 (11.9) 1 (2.4)
NAM, nasoalveolar molding; CLA, cleft lip adhesion; UCL, isolated unilateral cleft lip; IBCL, isolated bilateral cleft lip. *Percentages for no. of subjects were based on the 77 total subjects. All other percentages were based on the cohort sizes of 35 for NAM and 42 for CLA.
Costs The financial analysis of nasoalveolar molding versus cleft lip adhesion was based on the major charges and costs for surgery, orthodontics, and hospitalization. Nasoalveolar molding treatment charges were derived from orthodontic office visits and molding device charges, which averaged $8739.64 ± $113.44, whereas average molding costs were $3550.24 ± $667.27. Cleft lip adhesion treatment charges, comprising both hospital charges and surgical charges, were $15,415.77 ± $199.40, whereas average adhesion costs were $9370.55 ± $1691.79 (Fig. 3). Several multivariate linear regression models were created to test the effect of the independent variables on the outcome of log costs, all of which demonstrated
a significant decrease in the nasoalveolar molding costs compared with cleft lip adhesion costs. The model with the best fit (R2 = 0.34) is shown in Table 2 and demonstrated a regression coefficient of −1.0 (p < 0.0001; 95 percent CI, −1.4 to −0.62), indicating a significant decrease in log costs in the nasoalveolar molding group compared with the adhesion group. Burden of Care Nasoalveolar molding patients made an average of 11.14 ± 2.58 visits before their formal cleft lip repair, and they missed 6.11 ± 2.39 visits, or 35 percent of their total scheduled visits. The missed visits were composed of 5.49 ± 2.32 cancellations and 0.63 ± 1.09 no-show visits. Cleft lip adhesion patients made an average of 2.98 ± 1.09 visits before their formal cleft lip repair, and missed 0.79 ± 1.47 visits, or 14 percent of their total scheduled visits. The missed visits were composed of 0.62 ± 1.01 cancellations and 0.17 ± 0.58 no-show visits. Nasoalveolar molding patients had significantly more made, cancelled, no-show, and missed visits and a higher missed percentage than cleft lip adhesion patients (p < 0.0001) for all except no-show appointments (p = 0.0199) (Table 3). Treatment complications were higher in the cleft lip adhesion group than in the nasoalveolar molding group. The major complication we observed in the nasoalveolar molding groups was device related. Two patients (6 percent) had device-related complications, which included the following: one patient’s father broke the nasoalveolar molding device, and a new device had to be ordered. The patient was charged $1000, which was included in the financial analysis. Another
Fig. 3. Total charges for nasoalveolar molding (NAM) versus cleft lip adhesion (CLA). Nasoalveolar molding, SD = $544.90; total cleft lip adhesion, SD = $2859.14 (p < 0.0001).
1267 Copyright © 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.
Plastic and Reconstructive Surgery • December 2015 Table 2. Multivariate Linear Regression Model of Treatment Log Cost of Nasoalveolar Molding versus Cleft Lip Adhesion* Regression Coefficient
p
95% CI
−0.185 0.753 0.253 −1.00647 0.298 0.077 0.052 0.448 0.654
0.511 0.078 0.442
Background: Patients with complete cleft lip and palate may benefit from cleft lip adhesion or nasoalveolar molding before formal cleft lip repair. The authors compared the relative costs to insurers of these two treatment modalities and the burden of care to families. Methods: A retrospective analysis was performed of cleft lip and palate patients treated with nasoalveolar molding or cleft lip adhesion at The Children’s Hospital of Philadelphia between January of 2007 and June of 2012. Demographic, appointment, and surgical data were reviewed; surgical, inpatient hospital, and orthodontic charges and costs were obtained. Multivariate linear regression and two-sample, two-tailed independent t tests were performed to compare cost and appointment data between groups. Results: Forty-two cleft adhesion and 35 nasoalveolar molding patients met inclusion criteria. Mean costs for nasoalveolar molding were $3550.24 ± $667.27. Cleft adhesion costs, consisting of both hospital and surgical costs, were $9370.55 ± $1691.79. Analysis of log costs demonstrated a significant difference between the groups, with the mean total cost for nasoalveolar molding significantly lower than that for adhesion (p < 0.0001). Nasoalveolar molding patients had significantly more made, cancelled, no-show, and missed visits and a higher missed percentage than adhesion patients (p < 0.0001) for all except no-show appointments, (p = 0.0199), indicating a higher burden of care to families. Conclusions: Nasoalveolar molding may cost less before formal cleft lip repair treatment than cleft lip adhesion. Third-party payers who cover adhesion and not nasoalveolar molding may not be acting in their own best interest. Nasoalveolar molding places a higher burden of care on families, and this fact should be considered in planning treatment. (Plast. Reconstr. Surg. 136: 1264, 2015.)
C
left lip and palate is the most common congenital craniofacial anomaly, occurring at an estimated rate of one in 600 live births in the United States.1 Patients with wide cleft lip and palate may benefit from surgical or orthodontic modalities to align alveolar segments, decrease cleft distances, and improve nasal contour before formal cleft lip repair. Both cleft lip adhesion and nasoalveolar molding can assist in accomplishing these anatomical goals to improve overall aesthetic outcomes after formal cleft lip repair. From the Division of Plastic Surgery, Perelman School of Medicine at the University of Pennsylvania, The Children’s Hospital of Philadelphia. Received for publication October 12, 2012; accepted March 19, 2013. Copyright © 2015 by the American Society of Plastic Surgeons DOI: 10.1097/PRS.0b013e31829b69fe
1264
Cleft lip adhesion is the older of the two treatments and was initially described by Dr. B. Johanson in 1961, who performed it incidentally as a part of a maxillary alveolar cleft repair.2 Dr. Peter Randall is credited with popularizing the technique after he published a larger study of cleft lip adhesion in 1965. He described converting complete clefts into incomplete clefts at 3.5 months of age, which allowed for a more effective formal cleft lip repair, performed 1.1 to 1.4 months later.3 Methods have evolved since 1965, and the treatment has proven to be efficacious4–7 (Fig. 1). New York orthodontist Dr. Barry H. Grayson first described nasoalveolar molding in 1993. An Disclosure: The authors have no conflicts of interest to disclose or financial disclosures to report.
www.PRSJournal.com
Copyright © 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.
Volume 136, Number 6 • Cost of Therapy before Cleft Lip Repair
Fig. 1. (Left) Patient presenting at 1 month of age with wide unilateral cleft lip and palate before cleft lip adhesion. (Right) Patient at 2.5 months of age immediately following cleft lip adhesion.
impression is made of the cleft lip and palate within the first week after birth. This impression is used to make a mold plate, which is then inserted intraorally and adjusted weekly to align the alveolar segments. This usually allows for formal cleft lip repair between 3 and 5 months of age.8 Longterm studies on nasoalveolar molding also have shown it to be efficacious9,10 (Fig. 2). There is, however, a paucity of literature comparing the cost of these treatment modalities. Historically, insurers have been willing to cover surgical methods such as cleft lip adhesion, but have been more reticent to cover orthodonticbased treatments such as nasoalveolar molding. Our goal was to perform a formal cost analysis of cleft lip adhesion and nasoalveolar molding treatment in patients with cleft lip and palate at a large cleft referral center to determine whether third-party payers are behaving rationally from a financial perspective. In addition, we sought to compare the relative burden of care for families as described by duration of treatment, and appointments made, missed, and cancelled.
PATIENTS AND METHODS Following review and approval by the Institutional Review Board of The Children’s Hospital of Philadelphia, a retrospective cost analysis was performed on patients with cleft lip and palate presenting to The Children’s Hospital of Philadelphia between January of 2007 and June of 2012. Those patients who underwent either cleft lip adhesion
or nasoalveolar molding treatment identified by Current Procedural Terminology and billing codes were included for evaluation. Decision for cleft lip adhesion or nasoalveolar molding was made based on family willingness to adhere to the multiple office visits required for molding treatment, ability to comply with therapy, and insurance preapproval. Exclusion criteria included syndromic diagnoses, incomplete patient records, incomplete financial records, and not having undergone a formal cleft lip repair at the time of data extraction. Charts were reviewed by means of electronic medical record for demographics, including sex, race, and Veau cleft type. An assessment of the burden of care posed by adhesion and nasoalveolar molding was performed as a function of (1) number of made and missed appointments before formal cleft lip repair and (2) complications. The two types of appointments that were included in this study were visits to either an orthodontist or an attending plastic surgeon at the Cleft Lip and Cleft Palate Program at The Children’s Hospital of Philadelphia. Timing of treatment and complications of treatment were also collected and compared by twosample, two-tailed independent t test. Surgical and orthodontic charges and payments (costs) were compiled for individual cleft lip adhesion and nasoalveolar molding patients through the Department of Surgery’s accounting department. All dollars were adjusted to 2012 dollars using the latest Consumer Price Index data from the U.S. Department of Labor Bureau of Labor Statistics.11 The Fisher’s exact test was used
1265 Copyright © 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.
Plastic and Reconstructive Surgery • December 2015
Fig. 2. (Above, left) Patient on initial evaluation at 1 month of age showing wide cleft before nasoalveolar molding treatment. (Above, right) Patient with nasoalveolar molding device in place. (Below, left) Intraoral view of the wide cleft palate in the patient at 1 month of age, before nasoalveolar molding treatment. (Below, right) Inferior view of the patient at 1 month of age, before nasoalveolar molding treatment.
to compare demographic information. Multivariate linear regression analysis was performed on the log cost to determine the significance of various dependent variables on financial data. Log costs were then retransformed based on the Duan smearing retransformation to obtain mean costs for differing treatment groups.12 Two-sample, twotailed, t tests were performed to compare appointment data between groups.
RESULTS Patients A total 87 patients were identified who underwent either cleft lip adhesion or nasoalveolar molding treatment at The Children’s Hospital of
Philadelphia between January of 2007 and June of 2012. Ten patients were excluded for the following reasons: five were syndromic, two had not yet undergone formal cleft lip repair at the time of data extraction, two had incomplete financial information, and one underwent both cleft lip adhesion surgery and nasoalveolar molding treatment before formal cleft lip repair. Thus, a total of 77 patients were included in the study. Thirtyfive patients underwent nasoalveolar molding treatment, and 42 patients underwent adhesion surgery. Complete demographic data are listed in Table 1. There were no significant differences between the two treatment groups in terms of sex, race/ethnicity, or Veau classification (p = 0.49, p = 0.93, and p = 0.80, respectively).
1266 Copyright © 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.
Volume 136, Number 6 • Cost of Therapy before Cleft Lip Repair Table 1. Nasoalveolar Molding versus Cleft Lip Adhesion Demographics No. of subjects* Sex Female Male Type of cleft Veau III Veau IV IUCL* IBCL† Race/ethnicity White Black/African American Asian Other Uninsured
NAM (%)
CLA (%)
35 (45.5)
42 (54.5)
13 (37.1) 22 (62.9)
20 (47.6) 22 (52.4)
21 (60.0) 9 (25.7) 4 (11.4) 1 (2.9)
29 (69.0) 7 (16.7) 5 (11.9) 1 (2.4)
25 (71.4) 5 (14.3) 2 (5.7) 3 (8.6) 2 (5.7)
27 (64.3) 7 (16.7) 3 (7.1) 5 (11.9) 1 (2.4)
NAM, nasoalveolar molding; CLA, cleft lip adhesion; UCL, isolated unilateral cleft lip; IBCL, isolated bilateral cleft lip. *Percentages for no. of subjects were based on the 77 total subjects. All other percentages were based on the cohort sizes of 35 for NAM and 42 for CLA.
Costs The financial analysis of nasoalveolar molding versus cleft lip adhesion was based on the major charges and costs for surgery, orthodontics, and hospitalization. Nasoalveolar molding treatment charges were derived from orthodontic office visits and molding device charges, which averaged $8739.64 ± $113.44, whereas average molding costs were $3550.24 ± $667.27. Cleft lip adhesion treatment charges, comprising both hospital charges and surgical charges, were $15,415.77 ± $199.40, whereas average adhesion costs were $9370.55 ± $1691.79 (Fig. 3). Several multivariate linear regression models were created to test the effect of the independent variables on the outcome of log costs, all of which demonstrated
a significant decrease in the nasoalveolar molding costs compared with cleft lip adhesion costs. The model with the best fit (R2 = 0.34) is shown in Table 2 and demonstrated a regression coefficient of −1.0 (p < 0.0001; 95 percent CI, −1.4 to −0.62), indicating a significant decrease in log costs in the nasoalveolar molding group compared with the adhesion group. Burden of Care Nasoalveolar molding patients made an average of 11.14 ± 2.58 visits before their formal cleft lip repair, and they missed 6.11 ± 2.39 visits, or 35 percent of their total scheduled visits. The missed visits were composed of 5.49 ± 2.32 cancellations and 0.63 ± 1.09 no-show visits. Cleft lip adhesion patients made an average of 2.98 ± 1.09 visits before their formal cleft lip repair, and missed 0.79 ± 1.47 visits, or 14 percent of their total scheduled visits. The missed visits were composed of 0.62 ± 1.01 cancellations and 0.17 ± 0.58 no-show visits. Nasoalveolar molding patients had significantly more made, cancelled, no-show, and missed visits and a higher missed percentage than cleft lip adhesion patients (p < 0.0001) for all except no-show appointments (p = 0.0199) (Table 3). Treatment complications were higher in the cleft lip adhesion group than in the nasoalveolar molding group. The major complication we observed in the nasoalveolar molding groups was device related. Two patients (6 percent) had device-related complications, which included the following: one patient’s father broke the nasoalveolar molding device, and a new device had to be ordered. The patient was charged $1000, which was included in the financial analysis. Another
Fig. 3. Total charges for nasoalveolar molding (NAM) versus cleft lip adhesion (CLA). Nasoalveolar molding, SD = $544.90; total cleft lip adhesion, SD = $2859.14 (p < 0.0001).
1267 Copyright © 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.
Plastic and Reconstructive Surgery • December 2015 Table 2. Multivariate Linear Regression Model of Treatment Log Cost of Nasoalveolar Molding versus Cleft Lip Adhesion* Regression Coefficient
p
95% CI
−0.185 0.753 0.253 −1.00647 0.298 0.077 0.052 0.448 0.654
0.511 0.078 0.442
