Latest Review Date: September 2024

Category: Surgery      

DRAFT                                           

POLICY:

Effective for dates of service on and after December 2. 2024:

NOTE: 

• The scope of this policy does not address primary circumcision of newborns or infants.
• Coverage may be subject to legislative mandates, including but not limited to the following, which apply prior to the policy statements:
  • Federal Women’s Health and Cancer Rights Act (WHCRA)
  • Minnesota Statute 62A.25 Reconstructive Surgery

I.  Panniculectomy

• Panniculectomy with or without abdominoplasty may be considered medically necessary when all of the following criteria are met:
  • The pannus/panniculus extends at or below the level of the symphysis pubis; AND
  • The treating physician has documented that the pannus/panniculus is associated with:
    1. Chronic or recurrent infection, intertrigo or skin necrosis refractory to at least three months of medical management (e.g., antifungal, antibacterial, and moisture-absorbing agents; supportive garments, topically-applied skin barriers); OR
    2. Chronic or recurrent ulcerations, accompanied by skin deterioration, that are nonresponsive to aggressive wound management;  
    3. • • • Chronic or recurrent infection, intertrigo or skin necrosis refractory to at least three months of medical management (e.g., antifungal, antibacterial, and moisture-absorbing agents; supportive garments, topically applied skin barriers); OR
           • Chronic or recurrent ulcerations, accompanied by skin deterioration, that are nonresponsive to aggressive wound management; AND 
  • Patient is a never smoker OR has abstained from smoking, use of smokeless tobacco and/or nicotine products (not including nicotine replacement therapy (NRT)) a minimum of 6 weeks prior to planned surgery; AND
  • When the panniculectomy is associated with significant weight loss, weight has remained stable for a minimum of six months.
• Panniculectomy with or without abdominoplasty may be considered medically necessary as an adjunct to a medically necessary procedure when needed for exposure to improve surgical access or wound healing following surgery.
• The following procedures are considered COSMETIC as they are performed primarily to enhance or otherwise alter physical appearance without correcting or improving a physiological function:
  • Panniculectomy with or without abdominoplasty not meeting the medical necessity criteria in the policy statements directly above;
  • Abdominoplasty;
  • Nonfunctional procedures performed in association with a medically necessary panniculectomy (e.g., transposition of the umbilicus, undermining to the costal margin, lateral contouring imbrications, lipectomy);
  • Repair of diastasis recti.

II.  Excision of Redundant Skin or Tissue of Other Anatomical Areas

• Excision of redundant skin or tissue of other anatomical areas including but not limited to the upper extremities (e.g., brachioplasty), lower extremities, buttocks, or genitalia may be considered medically necessary when ALL of the following are met:
  • The treating physician has documented that the Redundant skin is associated with ONE of the following:
    1. Chronic or recurrent infection, intertrigo or skin necrosis refractory to at least three months of medical management (e.g., antifungal, antibacterial, and moisture-absorbing agents; supportive garments, topically-applied skin barriers); OR
    2. Chronic or recurrent ulcerations, accompanied by skin deterioration, that are nonresponsive to aggressive wound management OR
    3. Biopsy or removal of a premalignant or malignant skin lesion;
  • • •  
    • Chronic or recurrent infection, intertrigo or skin necrosis refractory to at least three months of medical management (e.g., antifungal, antibacterial, and moisture-absorbing agents; supportive garments, topically applied skin barriers); OR 
    • Chronic or recurrent ulcerations, accompanied by skin deterioration, that are nonresponsive to aggressive wound management; AND
• • Patient is a never smoker OR has abstained from smoking, use of smokeless tobacco, and/or nicotine products (not including nicotine replacement therapy (NRT)) for a minimum of 6 weeks prior to planned surgery.
• Excision of redundant skin or tissue of other anatomical areas may be considered medically necessary when the redundant skin is associated with a biopsy or removal of a premalignant or malignant skin lesion.
• Excision of redundant skin or tissue performed primarily to enhance or otherwise alter physical appearance is considered COSMETIC.

DOCUMENTATION SUBMISSION:

Documentation supporting the medical necessity criteria described in the policy must be included in prior authorization requests, when prior authorization is required. In addition, the following documentation must be submitted with the prior authorization request:

• Clinical notes documenting diagnosis and description of redundant skin or pannus/panniculus supporting the medical necessity of the procedure.
• Photographs of the affected area, including a lateral photograph of the panniculus
• Documentation from the medical records of the treating provider of the measures that were used to treat the chronic or recurrent skin infection.
• If applicable documentation that the patient is a never-smoker OR has abstained from smoking, use of smokeless tobacco and/or nicotine products (not including nicotine replacement therapy (NRT)) for a minimum of 6 weeks prior to surgery.

Effective for dates of service prior to December 2, 2024:

NOTE: 

• The scope of this policy does not address primary circumcision of newborns or infants.
• Coverage may be subject to legislative mandates, including but not limited to the following, which apply prior to the policy statements:
  • Federal Women’s Health and Cancer Rights Act (WHCRA)
  • Minnesota Statute 62A.25 Reconstructive Surgery

I.  Panniculectomy

• Panniculectomy with or without abdominoplasty may be considered medically necessary when all of the following criteria are met:
  • The pannus/panniculus extends at or below the level of the symphysis pubis; AND
  • The treating physician has documented that the pannus/panniculus is associated with:
    1. Chronic or recurrent infection, intertrigo or skin necrosis refractory to at least three months of medical management (e.g., antifungal, antibacterial, and moisture-absorbing agents; supportive garments, topically-applied skin barriers); OR
    2. Chronic or recurrent ulcerations, accompanied by skin deterioration, that are nonresponsive to aggressive wound management; AND 
  • Patient is a never smoker OR has abstained from smoking, use of smokeless tobacco and/or nicotine products, and/or nicotine replacement therapy for at least 6 weeks prior to planned surgery; AND
  • When the panniculectomy is associated with significant weight loss, weight has remained stable for a minimum of six months.
• Panniculectomy with or without abdominoplasty may be considered medically necessary as an adjunct to a medically necessary procedure when needed for exposure to improve surgical access or wound healing following surgery.
• The following procedures are considered COSMETIC as they are performed primarily to enhance or otherwise alter physical appearance without correcting or improving a physiological function:
  • Panniculectomy with or without abdominoplasty not meeting the medical necessity criteria in the policy statements directly above;
  • Abdominoplasty;
  • Nonfunctional procedures performed in association with a medically necessary panniculectomy (e.g., transposition of the umbilicus, undermining to the costal margin, lateral contouring imbrications, lipectomy);
  • Repair of diastasis recti.

II.  Excision of Redundant Skin or Tissue of Other Anatomical Areas

• Excision of redundant skin or tissue of other anatomical areas including but not limited to the upper extremities (e.g., brachioplasty), lower extremities, buttocks, or genitalia may be considered medically necessary when ALL of the following are met:
  • The treating physician has documented that the redundant skin is associated with:
    1. Chronic or recurrent infection, intertrigo or skin necrosis refractory to at least three months of medical management (e.g., antifungal, antibacterial, and moisture-absorbing agents; supportive garments, topically-applied skin barriers); OR
    2. Chronic or recurrent ulcerations, accompanied by skin deterioration, that are nonresponsive to aggressive wound management OR
    3. Biopsy or removal of a premalignant or malignant skin lesion AND
  • Patient is a never smoker OR has abstained from smoking, use of smokeless tobacco and/or nicotine products, and/or nicotine replacement therapy for at least 6 weeks prior to planned surgery.
• Excision of redundant skin or tissue performed primarily to enhance or otherwise alter physical appearance is considered COSMETIC.

DOCUMENTATION SUBMISSION:

Documentation supporting the medical necessity criteria described in the policy must be included in prior authorization requests, when prior authorization is required. In addition, the following documentation must be submitted with the prior authorization request:

• Photographs of the affected area, including a lateral photograph of the panniculus.
• Documentation from the medical records of the treating provider of the measures that were used to treat the chronic or recurrent skin infection.
• Documentation that the patient is a never-smoker OR has abstained from smoking, use of smokeless tobacco and/or nicotine products (not including nicotine replacement therapy (NRT) for a minimum of 6 weeks prior to surgery.

DESCRIPTION OF PROCEDURE OR SERVICE:

In the majority of circumstances, excision of excess skin or tissue is a cosmetic service. In certain locations of the body; however, this excess skin or tissue may create environments that are susceptible to skin infections. Such areas may include the abdomen, buttocks, thighs and upper arms.

Medical management by the application of skin barriers, moisture-absorbing agents, and/or the use of supportive garments is indicated as the first line of treatment. When the condition is persistent and remains refractory to standard, conservative treatment, surgical removal of the excess skin or tissue may be necessary. Examples of surgical procedures to remove excess skin or tissue include: panniculectomy, buttock lift, thigh lift, leg lift, or arm lift.

Definitions:

Abdominoplasty:  A procedure to remove excess abdominal skin and fat with or without tightening lax anterior abdominal wall muscles and with or without repositioning or reconstructing the navel.

Brachioplasty:  A procedure to remove loose skin and excess fat in the upper arm. Also called an "arm lift."

Cosmetic Services:  Surgery and other services performed primarily to enhance or otherwise alter physical appearance without correcting or improving a physiological function.

Costal margin:  Lower edge of the chest (bottom of the rib cage).

Diastasis recti:  Separation between the left and right side of the rectus abdominus, the muscle that covers the front of the abdomen. Diastasis recti appears as a ridge running down the midline of the abdomen from the bottom of the breastbone to the navel. Diastasis recti does not represent an abdominal wall hernia.

Imbrication:  Overlapping of tissue. In excision of excessive skin or tissue, it is used to contour tissue in the surgical area.

Lipectomy:  Surgical removal of fatty tissue beneath the skin.

Nicotine: A highly addictive chemical compound present in a tobacco plant. All tobacco and non-tobacco nicotine (NTN) products contain nicotine. Examples of nicotine products include cigarettes, non-combusted cigarettes, cigars, smokeless tobacco (e.g., dip, snuff, snus, chewing tobacco), hookah tobacco, e-cigarettes, and vape pens.

Nicotine Replacement Therapy (NRT): Products designed to help individuals quit smoking by delivering small amounts of nicotine to the brain without the toxic chemicals found in cigarette smoke. Examples include skin patches, gum, and lozenges.

Panniculectomy:  A procedure to remove fatty tissue and excess skin (pannus/panniculus) hanging down from the lower to middle portions of the abdomen.

Symphysis pubis:  The area in the groin where the left and right pubic bones are joined.

Umbilicus:  The navel. It is the scar on the abdomen at the site of the attachment of the umbilical cord.

KEY POINTS:

Summary of Evidence

The clinical evidence regarding the efficacy of panniculectomy at the time of bariatric surgery or following bariatric surgery and major weight loss for improving functional outcomes in patients with symptomatic panniculi is limited by a lack of quality studies that include sufficient numbers of patients to detect clinically meaningful treatment effects of this surgery as well as effects on patient-important outcomes. The evidence almost entirely reflects post-operative complications and lacks studies that evaluate objective efficacy outcomes. Despite these deficiencies, and the lack of established patient selection criteria, panniculectomy is in clinical use as a reconstructive abdominal-contouring procedure for patients undergoing obesity treatment, the goal of which is to improve panniculus-associated symptoms and to remove impediments to normal function.

Federal and state mandates may apply to patients with a history of breast cancer who have undergone mastectomy or other conditions under which potentially cosmetic procedures may meet the definition of reconstructive surgery. For consistency with other Blue Cross Blue Shield of Minnesota (BCBSMN) policies, this information has been added. The added coverage statement is more appropriate than the previous medically necessary statement for mandate related coverage.

The findings that current smokers have a higher risk of wound infection and wound disruption can be explained by the pathophysiological mechanisms related to the toxic effects and oxidative destruction induced by smoking and nicotine. Smoking impedes the innate defense system of the lung, including damaging mucus transport, aggravating mucus production, and diminishing macrophage function, resulting in increased risk of pulmonary complications. While NRT contains nicotine, it contains lower amounts without other carcinogens, and the impact on the body is more gradual. Plasma nicotine levels provided by NRT vary according to dose and delivery method but in general are lower than those maintained during active smoking. The exclusion of NRT will remove barriers to accessing surgical care and promote overall smoking cessation, while promoting consistency with clinical guidelines.  

Rationale:

Obesity, defined as a body mass index (BMI) of ≥ 30 kilograms per square meter (kg/m2), is associated with a number of comorbidities, including diabetes, hypertension, hyperlipidemia, obstructive sleep apnea, esophageal reflux disease, osteoarthritis, and cardiovascular disease, as well as an increase in all-cause mortality. Bariatric surgery is an effective and durable treatment for obesity, but the resulting weight loss may result in the development of a panniculus. The panniculus is redundant abdominal skin and fat that forms after a large reduction in weight, which hangs down and covers the pubis and groin. A panniculus may cause various skin problems (e.g., irritation, rash, inflammation, breakdown, ulcers, hygiene issues); negatively impact activities of daily living or quality of life; interfere with respiratory function; or cause abdominal lymphedema, hernias, or pain.

Factors that may influence the skin’s ability to contract following a large reduction in body weight include age, sex, amount or speed of weight loss, nutrition, hormones, lifetime sun exposure, smoking, use of certain drugs or chemicals, and genetics. Studies have shown that skin quality is altered in patients who have undergone massive weight loss (MWL), with a marked weakening of the epidermis due to a reduction in the density of collagen and elastic fiber networks. Treatments for skin deformities due to MWL, such as panniculi, are body-contouring procedures that include panniculectomy, abdominoplasty, lipectomy, torsoplasty, and lower body lifts. When it can be shown the condition is creating environments that are susceptible to skin infections, surgical removal may be indicated. When the procedure is performed solely to enhance an individual’s appearance in the absence of functional abnormalities, it would be considered cosmetic.

Panniculectomy is the surgical excision of an abdominal panniculus—a hanging flap of excess skin and fat around the abdomen—in a transverse or vertical wedge, but does not include muscle plication, neoumbilicoplasty, or flap elevation. It is ideally performed at least 1 year after bariatric surgery, after weight loss has stabilized. Panniculectomy may be performed after weight loss produced by bariatric surgery or diet and exercise, or at the same time as bariatric surgery in obese patients. A 3-month period of conservative treatment has been added to the medical necessity criteria for the coverage of panniculectomy and excision of other redundant skin and tissue. The 2017 American Society of Plastic Surgery (ASPS) Practice Parameter for Surgical Treatment of Skin Redundancy for Obese and Massive Weight Loss Patients, states that “patients considered for panniculectomy may be required to/should document the type and duration of symptoms/ treatment for panniculitis”, and calls “documented recalcitrant panniculitis” an indication for panniculectomy. Addition of the 3-month period requirement will provide clarity for reviews of such requests. These ASPS guidelines also state that “Body contouring surgery is ideally performed after the patient maintains a stable weight for two to six months. For post bariatric surgery patients, this often occurs 12-18 months after surgery or at the 25 kg/mg2 to 30 kg/mg2 weight range. Sometimes procedures are staged. An initial functional panniculectomy with limited tissue undermining and/or reduction mammaplasty may be necessary to increase the patient’s comfort and facilitate the ease of exercise and further weight loss. Once the patient approaches his/her ideal body weight more refined body contouring surgery may be performed to address aesthetic issues.”

Per the 2020 Hayes, Inc. Panniculectomy For Treatment Of Symptomatic Panniculi Health Technology Assessment report, the overall quality of the evidence for panniculectomy after MWL is low, based on a body of evidence that consists of poor-quality studies. Despite the lack of evidence regarding the efficacy of panniculectomy after MWL (e.g., improvement in symptoms or panniculus severity), clinical trials appear to be focused on improving wound-related complications rather than providing evidence of efficacy. In 2004, Acarturk et al. compared the incidence of wound infections based on when the panniculectomy was performed relative to bariatric surgery. The authors reported a significantly greater incidence of wound infections in the concurrent group compared to later group (48% and 16% respectively; P<0.05). 123 panniculectomies were performed over 5 years on patients (34 males, 89 females; mean age 44.5 +/- 10.3 years) undergoing bariatric surgery. The panniculectomy was either done at the same time as the bariatric surgery in 21 patients or after a time period of 17 +/- 11 months in 102 patients. The pre-bariatric surgery weight ranged from 107 to 341 kg (mean: 168.6 +/- 47.2 kg) with a mean body mass index (BMI) of 59 +/- 14 kg/m. After the bariatric surgery, the patients had an average weight loss of 57.6 +/- 27 kg. The pre-panniculectomy weight was 121.9 +/- 39.3 kg (BMI = 43.1 +/- 12.4 kg/m) for the patients who had the panniculectomy after the bariatric surgery. Ninety-two percent of the patients had multiple comorbidities. The weight of the panniculectomy specimen ranged from 4 to 54 kg. Any abdominal wall hernias (35.4% incisional and 8.9% umbilical) were fixed during the panniculectomy. Overall, patients who had panniculectomy simultaneously with the bariatric surgery had more complications than patients who had panniculectomy after their bariatric surgery. The wound infections were 48% versus 16% and respiratory distress was 24% versus 0%, respectively. The skin necrosis was 10% versus 6%, dehiscence was 33% versus 13%, and hematoma formation was 10% versus 2%, respectively. Overall, the patients had good outcomes, with 3 postoperative deaths in the group with panniculectomy at the same time of bariatric surgery. An interval of weight loss prior to the procedure makes this procedure safer and more effective.

In 2015, Barbour et al. published a retrospective uncontrolled study that compared post-operative complications after panniculectomy performed after MWL due to either bariatric surgery or diet/exercise. One hundred sixty-one consecutive patients undergoing elective panniculectomy after bariatric surgery or diet-controlled weight loss were identified. Patient demographics and nutritional indices (serum protein, albumin, and micronutrient levels) were analyzed. Complications including wound separation, infection, and operative debridements were compared. Post hoc comparisons tested for correlation between complications and nutritional markers. Post bariatric patients lost an average of 151 lb. and presented at an average of 32 months after gastric bypass. Diet-controlled weight loss patients lost an average of 124 lb. Despite MWL, albumin levels were higher in the bariatric group (3.8 vs 3.4 g/dL, P < 0.05). Conversely, bariatric patients experienced increased wound complications (27% vs 14%; P < 0.05). Factors which were found to correlate to increased risk of wound dehiscence and infection were elevated body mass index at time of panniculectomy and amount of tissue removed. Multivariate analysis did not show serum albumin or percent weight loss to independently predict complications. The authors concluded that bariatric patients presenting for elective operations are at risk for protein and micronutrient deficiency. Despite aggressive replacement and normalization of nutritional markers, bariatric patients experience increased wound complications when compared to non-bariatric patients and traditional measures of nutritional evaluation for surgery may be insufficient in bariatric patients.

In 2022, Samuel et al. sought to better establish the association of known risk factors that can complicate the postoperative care of the panniculectomy patient, and whether or not bariatric surgery plays a role in the development of these complications. The retrospective review identified patients that underwent a panniculectomy between 2010 and 2018, along with their  various complications; descriptive statistics as well as a multivariate analysis were used to evaluate the association of risk factors and complications. A total of 8,282 panniculectomy patients were identified. Of these, 1,420 underwent bariatric weight loss surgery prior to their panniculectomy, whereas the remaining 6,869 underwent a panniculectomy alone. Obesity, tobacco use, and diabetes were significant in developing a surgical site infection, wound disruption, and the need to undergo reoperation. Charlson Comorbidity Index greater than one (CCI>1), male gender, age greater than 60, COPD, and HTN identified as potential risk factors in developing various complications. Although patients with prior weight loss surgery had a history significant for prior comorbidities, the overall postoperative complication rate was decreased compared to those who did not undergo preoperative bariatric surgery. The incidence of undergoing a panniculectomy has increased significantly, particularly following bariatric surgery. Identifying potential risk factors in this patient population could better help identify postoperative complications following a panniculectomy and perhaps allow for targeted intervention and medical optimization prior to surgery.

In 2022, Kalmar et al. published the results of a retrospective cohort study of patients undergoing cosmetic abdominoplasty and functional panniculectomy in North America between 2015 and 2019 using the National Surgical Quality Improvement Program database sponsored by the American College of Surgeons. Comorbidities and postoperative complications between these two cohorts were analyzed with appropriate statistics. During the study interval, 11,137 patients underwent excision of excessive infraumbilical abdominal skin, including 57.4% (n = 6397) patients undergoing functional panniculectomy and 42.6% (n = 4740) patients undergoing cosmetic abdominoplasty. Patients undergoing functional panniculectomy were significantly more likely to have comorbidities than those undergoing cosmetic abdominoplasty (p < .001). Overall adverse events (p < .001), medical complications (p = .047), surgical complications (p < .001), related readmission (p < .001), and related reoperation (p < .001) were significantly higher in patients undergoing functional panniculectomy. Surgical complications significantly higher in functional panniculectomy included superficial incisional infection (p < .001), deep incisional infection (p < .001), organ/space infection (p < .001), dehiscence (p = .003), and bleeding requiring transfusion (p = .003). Patients undergoing functional panniculectomy are significantly more likely to have comorbidities and experience postoperative wound infection, dehiscence, sepsis, bleeding, related readmission, and related reoperation.

In 2022, Kalmar et al. also conducted a retrospective cohort study to determine whether cosmetic abdominoplasty increases risk for thromboembolic events compared with functional panniculectomy. This was accomplished by using the National Surgical Quality Improvement Program database for excision of excessive subcutaneous infraumbilical skin and soft tissue at participating hospitals between 2015 and 2019. Procedures performed for cosmetic abdominoplasty versus functional panniculectomy were compared for occurrences of postoperative pulmonary embolism (PE). During the study interval, 11,137 patients underwent excision of excessive infraumbilical abdominal skin, including 57.4% (n = 6397) patients undergoing functional panniculectomy and 42.6% (n = 4740) patients undergoing cosmetic abdominoplasty. Patients undergoing functional panniculectomy were significantly more likely to have comorbidities than those undergoing cosmetic abdominoplasty ( P < 0.001). The risk for postoperative PE was independently associated with cosmetic abdominoplasty ( P < 0.001), elevated body mass index ( P = 0.001), preoperative recent weight loss ( P = 0.006), and concurrent hernia repair ( P = 0.049). Most PE events occurred outpatient after discharge (87.2%), and the average postoperative time from surgery until PE was 10.5 ± 6.7 days. The authors concluded that cosmetic abdominoplasty has greater than 4 times the risk of postoperative PE than functional panniculectomy. Risk of PE is further increased by concurrent hernia repair, elevated body mass index, and rapid weight loss in the immediate preoperative period. It may be advisable to caution patients to delay abdominal excisional body contouring procedures until their weight has plateaued.

In 2022, Stewart et al. published the results of a retrospective chart review study performed on 225 consecutive patients who had undergone panniculectomy from 2002 and 2020, to evaluate long-term outcomes and weight loss after panniculectomy. Demographic variables including smoking status, medical comorbidities, and prior history of weight loss/bariatric surgery were collected for 173 patients. Preoperative and postoperative body mass index (BMI) were calculated in addition to postoperative outcomes. The study population was 85% female with a mean age of 57 years and an average follow-up of 3.9 years. Relevant comorbidities included obesity (88%), hypertension (65%), diabetes (37%), and smoking (8%), and the majority (53%) of patients had undergone prior bariatric surgery. The overall complication rate was 40%. Twenty percent of patients required reoperation or readmission, and 20% had minor complications addressed in an outpatient setting. Patients who had higher preoperative BMI experienced a significant long-term reduction in BMI. In addition, patients who did not undergo prior bariatric surgery tended to lose weight more often and by larger amounts than patients who had prior bariatric surgery (71.6% vs 57.6, P = 0.023). Complications were not uncommon and included infection (17%), delayed wound healing (16%), seroma (8%), and hematoma (3%). Patients who had prior bariatric surgery were at reduced risk of any complication (P = 0.012). Smoking increased the incidence of infection (38.5% of smokers vs 15.6% of nonsmokers, P = 0.039). Concomitant hernia repair increased the risk of overall complications (64.3% vs 35.9%, P = 0.003) and delayed wound healing (39.2% vs 11.7%, P < 0.001). In the subgroup of patients who did not lose weight, a panniculus weight greater than 5 kg was associated with an increased complication rate (61.5% vs 27%, P = 0.03). Patients who underwent a panniculectomy tended to lose weight postoperatively, particularly those who had not undergone previous bariatric surgery. Complications were not uncommon, especially in patients with a smoking history. Prior bariatric surgery patients had a significant decrease in postoperative complications but tended to lose less weight after panniculectomy than those without prior bariatric surgery. Concomitant hernia repair put patients at an increased risk of complications.

As noted above, a patients smoking history can greatly impact post-panniculectomy and/or redundant skin excision procedure wound healing. The CDC has incorporated the use of many devices into the description of tobacco products. Vapes, vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigarettes or e-cigs), e-cigars, and e-pipes are some of the many tobacco product terms used to describe electronic nicotine delivery systems (ENDS). In 2022, Chiang et.al. published results on a retrospective, cohort study of 1,156,002 patients, utilizing files of the American College of Surgeons National Surgical Quality Improvement Program database. Multivariable logistic regression was used to calculate the odds ratios (ORs) with 95% confidence intervals (CIs) for postoperative wound complications, pulmonary complications, and in-hospital mortality associated with smokers. Smoking was associated with a significantly increased risk of postoperative wound disruption (OR 1.65, 95% CI 1.56-1.75), surgical site infection (OR 1.31, 95% CI 1.28-1.34), reintubation (OR 1.47, 95% CI 1.40-1.54), and in-hospital mortality (OR 1.13, 95% CI 1.07-1.19) compared with nonsmoking. The length of hospital stay was significantly increased in smokers compared with non-smokers. They found that current smokers who underwent surgery had approximately 30% increased odds of developing surgical site infection (SSI) and 65% increased odds of developing wound disruption. Study conclusions state smoking status is related to increased perioperative risk for wound complications following major surgical procedures. The current literature review has shown that smoking harms wound healing. The study adds to existing evidence and improves understanding of healing complications in smoking surgical cases. Wound complications are associated with other adverse outcomes and have a significant impact on patient quality of life and health care budgets. Therefore, patients who smoke should be informed about the potentially increased risks of complications before surgery. Concluding results encourage smoking cessation prior to surgery.

Liu et al. in 2022 published a meta-analysis on the effect of preoperative smoking and smoking cessation on wound healing and infection in post-surgery subjects. This analysis incorporated 11 trials involving 218,567 patients following surgery; 176,670 were previous or non-smokers, and 41,897 were smokers. Never smokers or those who had ceased smoking had significantly lower postoperative wound healing problems (odds ratio 0.74; 95% CI 0.63-0.87, p < .001) compared with smokers. Non-smokers had significantly lower postoperative wound healing problems and surgical site wound infection compared with smokers.

In 2012, Sorensen et al. reported on the results of a meta-analysis that sought to clarify the evidence on smoking and postoperative healing complications across surgical specialties and determine the impact of perioperative smoking cessation intervention. Smokers and non-smokers were compared in 140 cohort studies that included 479,150 patients. Pooled adjusted odds ratios (95% CI) were 3.60 (2.62 - 4.93) for necrosis, 2.07 (1.53-2.81) for healing delay and dehiscence, 1.79 (1.57-2.04) for surgical site infection, 2.27 (1.82-2.84) for wound complications, 2.07 (1.23-3.47) for hernia, and 2.44 (1.66-3.58) for lack of fistula or bone healing. Former smokers and patients who never smoked were compared in 24 studies including 47,764 patients, and former smokers and current smokers were compared in 20 studies including 40,629 patients. The pooled unadjusted odds ratios were 1.30 (1.07-1.59) and 0.69 (0.56-0.85), respectively, for healing complications combined. In 4 randomized controlled trials, smoking cessation intervention reduced surgical site infections (odds ratio, 0.43 [95% CI, 0.21-0.85]), but not other healing complications (0.51 [0.22-1.19]). Investigators concluded that postoperative healing complications occur significantly more often in smokers compared with non-smokers and in former smokers compared with those who never smoked. Perioperative smoking cessation intervention reduces surgical site infections, but not other healing complications.

In 2012, Wong et al. examined the effects of short-term preoperative smoking cessation on postoperative complications in a systematic review. 25 studies were included to assess the risks or benefits of short-term (less than 4 weeks) smoking cessation on postoperative complications and to derive the minimum duration of preoperative abstinence from smoking required to reduce complications in adult surgical patients. Compared with current smokers, the risk of respiratory complications was similar in smokers who quit less than two or two to four weeks before surgery (risk ratio [RR] 1.20; 95% confidence interval [CI] 0.96 to 1.50 vs RR 1.14; CI 0.90 to 1.45, respectively). Smokers who quit more than four and more than eight weeks before surgery had lower risks of respiratory complications than current smokers (RR 0.77; 95% CI 0.61 to 0.96 and RR 0.53; 95% CI 0.37 to 0.76, respectively). For wound-healing complications, the risk was less in smokers who quit more than three to four weeks before surgery than in current smokers (RR 0.69; 95% CI 0.56 to 0.84). Few studies reported cardiovascular complications and there were few deaths. Conclusions were that at least 4 weeks of abstinence from smoking reduces respiratory complications, and that less than 4 weeks did not appear to increase or decrease those same complications.

In 2011, Mills et al. also published a systematic review assessing smoking cessation on postoperative complications. Included were 6 randomized controlled trials and 15 observational studies. The results of pooled randomized controlled trials demonstrated a relative risk reduction of 41% (95% confidence interval [CI], 15 -59, p = .01) for prevention of postoperative complications. Each week of cessation increased the magnitude of effect by 19%. Trials of at least 4 weeks’ smoking cessation had a significantly larger treatment effect than shorter trials (p = .04). Observational studies demonstrated important effects of smoking cessation on decreasing total complications (relative risk [RR] 0.76, 95% CI, 0.69-0.84, p = .0001, I2 = 15%). This also was observed for reduced wound healing complications (RR 0.73, 95% CI, 0.61-0.87, p = .0006, I2 = 0%) and pulmonary complications (RR 0.81, 95% CI, 0.70-0.93, p = .003, I2 = 7%). Observational studies examining duration of cessation demonstrated that longer periods of cessation, compared with shorter periods, had an average reduction in total complications of 20% (RR 0.80, 95% CI, 3-33, p = .02, I2 = 68%). Investigators concluded that smoking cessation before any type of surgery reduces risks of complications, including wound healing and pulmonary complications; longer periods of smoking cessation decreased the incidence of postoperative complications.

Nolan and Warner (2015) authored a narrative review to discuss the current evidence for nicotine replacement therapy’s (NRT)efficacy and safety in patients scheduled for surgical treatment and other invasive procedures. Noting the lack of human trials, the authors stated that although available data are limited, there is no evidence from human studies that NRT increases the risk of healing-related or cardiovascular complications. Clinical trials of tobacco use interventions that include NRT have found either no effect or a reduction in complications. Authors concluded that given the benefits of smoking abstinence to both perioperative outcomes and long-term health and the efficacy of NRT in achieving and maintaining abstinence, any policies that prohibit the use of NRT in surgical patients should be reexamined.

In 2020, Stefan et al reported on a retrospective study (n=147,506). Researchers analyzed the association between nicotine replacement therapy (within 2 days of admission) and inpatient complications and outcomes. In the propensity-matched analysis, there was no association between receipt of NRT and in-hospital complications (OR, 0.99; 95% CI, 0.93-1.05), mortality (OR, 0.84; 95% CI, 0.68-1.04), all-cause 30-day readmissions (OR, 1.02; 95% CI, 0.97-1.07), or 30-day readmission for wound complications (OR, 0.96; 95% CI, 0.86-1.07). Authors concluded that this demonstrates that perioperative NRT is not associated with adverse outcomes after surgery. These results strengthen the evidence that NRT should be prescribed routinely in the perioperative period.

The American Society of Anesthesiologists (ASA) issued a Statement on Smoking Cessation in 2008 (reaffirmed in 2018). This statement indicated that as smoking has a direct impact on postoperative outcomes such as wound healing, and abstinence my improve these outcomes, patient should abstain from smoking for as long as possible both before and after surgery, and they should obtain help in doing so. Surgery may represent a teachable moment for promotion of long-term smoking cessation. In 2020, the Society for Perioperative Assessment and Quality Improvement (SPAQI) convened a multidisciplinary panel of 17 experts in perioperative smoking cessation. Members of the Task Force were from the fields of anesthesiology, internal medicine, surgery, public health, and pharmacy from both academic and nonacademic settings in Canada, United States, Australia, New Zealand, Asia, and Europe. The consensus statement resulting from this gathering includes the following: Interventions should occur as soon as practicable in relation to surgical scheduling. Evidence from observational studies of spontaneous quitting suggests that longer durations of preoperative abstinence are associated with lower rates of respiratory and wound healing complications. Evidence from RCTs supports an effect of preoperative smoking cessation interventions that are 4–8 weeks long.

In 2024, The National Comprehensive Cancer Network (NCCN) published guidelines on smoking cessation. The guideline states the following: Nicotine replacement therapy (NRT) is not a contraindication to surgery. There is no evidence that NRT degrades the wound-healing benefits of abstinence from smoking in humans. NRT offers benefits over continued smoking. NRT typically provides less nicotine than cigarettes, and nearly doubles the chance of smoking abstinence.

The Federal Women’s Health and Cancer Rights Act of 1998 (WHCRA) requires coverage by group health plans and individual health insurance policies to cover reconstruction after surgery for breast cancer including: All stages of reconstruction of the breast on which the mastectomy has been performed; surgery and reconstruction of the other breast to produce a symmetrical appearance; and prostheses and treatment of physical complications of all stages of the mastectomy, including lymphedema.

Minnesota Statute 62A.25 Reconstructive Surgery, requires health insurance plans operating in Minnesota to cover all stages of reconstruction of the affected and contralateral breast if a mastectomy is medically necessary as determined by the attending physician. Subd. 2. regarding required coverage also states: (a) Every policy, plan, certificate, or contract to which this section applies shall provide benefits for reconstructive surgery when such service is incidental to or follows surgery resulting from injury, sickness, or other diseases of the involved part or when such service is performed on a covered dependent child because of congenital disease or anomaly which has resulted in a functional defect as determined by the attending physician.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Covered if covered by the Participating Home Plan

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

REFERENCES:

1. Acarturk TO, Wachtman G, Heil B, Landecker A, Courcoulas AP, Manders EK. Panniculectomy as an adjuvant to bariatric surgery. Ann Plast Surg. 2004;53(4):360-367. 

2. Alverdy JC, Prachand V. Smoking and Postoperative Surgical Site Infection: Where There's Smoke, There's Fire. JAMA Surg. 2017;152(5):484. 

3. American Society of Anesthesiologists (ASA). Statement on Smoking Cessation. 2008, reaffirmed October 2018.

4. American Society of Plastic Surgeons (ASPS). ASPS recommended insurance coverage criteria for third-party payers: Surgical treatment of skin redundancy for obese and massive weight loss patients. 2017. 
5. American Society of Plastic Surgeons. Practice Parameter for Surgical Treatment of Skin Redundancy for Obese and Massive Weight Loss Patients. June 2017. 
6. Barbour JR, Iorio ML, Oh C, Tung TH, O'Neill PJ. Predictive Value of Nutritional Markers for Wound Healing Complications in Bariatric Patients Undergoing Panniculectomy. Ann Plast Surg. 2015;75(4):435-438. 
7. Center for Disease Control and Prevention, Electronic Nicotine Delivery Systems, Electronic Cigarettes. July 12, 2021. Retrieved from cdc.gov.
8. Centers for Medicare & Medicaid Services. The Center for Consumer Information & Insurance Oversight. Women’s Health and Cancer Rights Act (WHCRA). www.cms.gov/CCIIO/Programs-and-Initiatives/Other-Insurance-Protections/whcra_factsheet Accessed July 20, 2020.
9. Cooper JM, Paige KT, Beshlian KM, Downey DL, Thirlby RC. Abdominal panniculectomies: high patient satisfaction despite significant complication rates. Ann Plast Surg. 2008;61(2):188-196. 
10. Dreifuss SE, Rubin JP. Insurance coverage for massive weight loss panniculectomy: a national survey and implications for policy. Surg Obes Relat Dis. 2016;12(2):412-416.
11. Fan Chiang YH, Lee YW, Lam F, Liao CC, Chang CC, Lin CS. Smoking increases the risk of postoperative wound complications: A propensity score-matched cohort study. Int Wound J. 2023;20(2):391-402. 
12. Grønkjær M, Eliasen M, Skov-Ettrup LS, et al. Preoperative smoking status and postoperative complications: a systematic review and meta-analysis. Ann Surg. 2014;259(1):52-71. 
13. Hayes, Inc. Evidence Analysis Research Brief, Panniculectomy for Treatment of Symptomatic Panniculi. July 25, 2023.
14. Hayes, Inc. Hayes Directory: Panniculectomy for Treatment of Symptomatic Panniculi. May 2016. Annual review last updated April 2018. Lansdale, PA. 
15. Hayes, Inc. Hayes Technology Assessment. Panniculectomy For Treatment Of Symptomatic Panniculi. May 2016. Annual review last updated September 2020. Lansdale, PA. 
16. InterQual® 2018 CP: Procedures. Panniculectomy, Abdominal. 
17. Kalmar CL, Park BC, Kassis S, Higdon KK, Perdikis G. Functional panniculectomy vs cosmetic abdominoplasty: Multicenter analysis of risk factors and complications. J Plast Reconstr Aesthet Surg. 2022;75(9):3541-3550. 
18. Kalmar CL, Thayer WP, Kassis S, Higdon KK, Perdikis G. Pulmonary Embolism Risk After Cosmetic Abdominoplasty and Functional Panniculectomy. Ann Plast Surg. 2022;89(6):664-669. 
19. Liu D, Zhu L, Yang C. The effect of preoperative smoking and smoke cessation on wound healing and infection in post-surgery subjects: A meta-analysis. Int Wound J. 2022;19(8): 2101-2106. 
20. Mills E, Eyawo O, Lockhart I, Kelly S, Wu P, Ebbert JO. Smoking cessation reduces postoperative complications: a systematic review and meta-analysis. Am J Med. 2011;124(2):144-154.e8. 
21. Minnesota Statutes. Chapter 62A.25 Reconstructive Surgery. www.revisor.mn.gov/statutes/cite/62A.25. 
22. National Comprehensive Cancer Network. Smoking Cessation (Version 1.2024). www.nccn.org/professionals/physician_gls/pdf/smoking.pdf
23. Nolan MB, Warner DO. Safety and Efficacy of Nicotine Replacement Therapy in the Perioperative Period: A Narrative Review. Mayo Clin Proc. 2015;90(11):1553-1561. 
24. Samuel AR, Hakami L, Campbell C, DeGeorge BR Jr, Black J, Stranix JT. "Abdominal panniculectomy: Identifying complications and potential risk factors". J Plast Reconstr Aesthet Surg. 2022;75(9):3534-3540. 
25. Sørensen LT. Wound healing and infection in surgery. The clinical impact of smoking and smoking cessation: a systematic review and meta-analysis. Arch Surg. 2012;147(4):373-383.  
26. Stefan MS, Pack Q, Shieh MS, et al. The Association of Nicotine Replacement Therapy with Outcomes Among Smokers Hospitalized for a Major Surgical Procedure. Chest. 2020;157(5):1354-1361. 
27. Stewart CM, Faaborg-Andersen C, Baker N, Losken A. Evaluating Outcomes and Weight Loss After Panniculectomy. Ann Plast Surg. 2021;87(5):552-555. 
28. U.S. Food and Drug Administration, Products, Guidance and Regulations. Updated June 3, 2020. Accessed June 7, 2023. www.fda.gov/tobacco-products/products-guidance-regulations
29. U.S. Food and Drug Administration. Tobacco, June 29, 2022. Retrieved from: www.fda.gov/tobacco-products/products-ingredients-components/e-cigarettes-vapes-and-other-electronic-nicotine-delivery-systems-ends.
30. Wong J, An D, Urman RD, et al. Society for Perioperative Assessment and Quality Improvement (SPAQI) Consensus Statement on Perioperative Smoking Cessation. Anesth Analg. 2020;131(3):955-968. 
31. Wong J, Lam DP, Abrishami A, Chan MT, Chung F. Short-term preoperative smoking cessation and postoperative complications: a systematic review and meta-analysis. Can J Anaesth. 2012;59(3):268-279. 

POLICY HISTORY

Reviewed and posted July 1, 2021.

August 2021: Annual review completed. No change to policy intent.

September 2022: Policy Statement updated to include criteria pertaining to smoking status. Policy on draft September 16, 2022 through October 30, 2022.

August 2023: Policy Statement updated to include criteria pertaining to use of smokeless tobacco and/or nicotine products, and/or nicotine replacement therapy.

Policy on draft August 15, 2023 through October 4, 2023.

August 2024: Updates to Description, and Key Points section created. Policy Statement updated to include revisions pertaining to use of smokeless tobacco and/or nicotine products (not including nicotine replacement therapy (NRT)). Updates to Documentation Submission, and Reference section created.

Policy on draft August 12, 2024 through October 6, 2024.

October 2024: Updates the Policy Statement to include revisions pertaining to the treating physician documentation for pannus/panniculus is associated with chronic or recurrent infection or ulcerations. Excision of redundant skin or tissue of other anatomical areas associated with chronic or recurrent infection or ulcerations. Updates to Document Submissions.

Policy on draft from October 16, 2024 through December 1, 2024

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.