National Medical Policy

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1 National Medical Policy Subject: Policy Number: Cosmetic and Reconstructive Surgery NMP169 Effective Date*: October 2004 Updated: December 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State's Medicaid manual(s), publication(s), citations(s) and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation X Local Coverage Determination (LCD)* Article (Local)* Cosmetic and Reconstructive Surgery; Plastic Surgery:: Other None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located Cosmetic and Reconstructive Surgery Dec 15 1

2 outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Reconstructive Procedures Note: Photographs, copies of consultations, operative reports and any other pertinent information must be submitted for review. Health Net, Inc. considers any of the following reconstructive procedures medically necessary: 1. Surgery to correct congenital defects that cause significant functional deficiencies or challenges of any body part, developmental abnormalities, degeneration defects, trauma, infections, tumors or disease 2. Facial surgery to correct congenital, acquired, traumatic, or developmental anomalies that may not result in functional impairment, bur are so severely disfiguring as to merit consideration for corrective surgery (e.g. the craniofacial anomalies associated with Crouzon s Syndrome and Treacher-Collins Syndrome) 3. Surgery in connection with treatment of severe burns. Rhytidectomy (face lift) for the treatment of burns 4. Surgery for therapeutic purposes which coincidentally also serve some cosmetic purpose 5. Insertion or injection of prosthetic material for significant deformity from disease or trauma 6. Pulsed dye laser therapy for the treatment of congenital port wine stains of the face or neck 7. The intense pulsed light sources (IPLS; e.g., PhotoDerm VL) for medically appropriate treatment of congenital port wine stains when there is documented evidence of failure of treatment with pulsed dye laser therapy 8. Excision/treatment of tattoos of traumatic or therapeutic origins 9. Surgical treatment of congenital hemangiomas when any of the following are met: The hemangioma is interfering with the functionality of the nose, eyes, ears, lips or larynx; or The hemangioma is symptomatic (e.g., bleeding, painful, ulcerated, recurrent infection); or The hemangioma is associated with Kasaback-Merritt Syndrome*; or The hemangioma is pedunculated Note: Kasaback-Merritt Syndrome is a disorder characterized by visible, aggressively growing hemangiomas and thrombocytopenia, which can predispose an affected child to significant bleeding. 10. Repair/revision of scars, including keloids, originating from a covered surgical or therapeutic procedure or an accidental injury that are associated with significant symptoms of pain, burning or itching which cannot effectively be treated with non-narcotic analgesics and/or steroid injections, that interferes with normal Cosmetic and Reconstructive Surgery Dec 15 2

3 bodily function such as the movement of a joint, or are unstable and have a history of intermittent breakdown 11. Low-dose radiation (superficial or interstitial) as an adjunctive therapy immediately following excisional surgery (within 7 days) in the treatment of keloids where medical appropriateness criteria for keloid removal are met 12. Testicular prostheses for replacement of congenitally absent testes, or testes lost due to disease, injury, or surgery 13. Excision of lipoma(s) when located in an area(s) of repeated touch or pressure with documentation of tenderness and/or inhibition of the patient s ability to perform activities of daily living 14. Skin tag removal when located in an area of friction with documentation of repeated irritation and bleeding 15. Tattooing in conjunction with reconstructive breast surgery post-mastectomy 16. An eye prosthesis for a patient with absence or shrinkage of an eye due to birth defect, trauma, or surgical removal. Polishing and resurfacing is covered on a twice per year basis. Replacement is covered every five (5) years with exceptions allowed when documentation supports medical necessity for more frequent replacement. One enlargement or reduction of the prosthesis is covered without documentation. 17. Blepharoplasty (eye lid lift) when criteria in National Medical Policy on Blepharoplasty are met 18. External facial prosthesis when there is loss or absence of facial tissue due to disease, trauma, surgery, or a congenital defect, regardless of whether or not the facial prosthesis restores function 19. Chin, cheek, or jaw reshaping (facial implants or soft tissue augmentation) for deformities of the maxilla or mandible resulting from trauma or disease and to be distinguished form orthognathic surgery (See National Medical Policy on Orthognathic Surgery) 20. Dermal chemical peels for actinic keratoses and other pre-malignant skin lesions when patients have 15 or more lesions, such that it becomes impractical to treat each lesion individually, and they have failed to adequately respond to treatment with topical 5-FU. 21. Punch graft hair transplant may be considered reconstructive when it is performed to correct permanent hair loss that is clearly caused by disease or injury (e.g., eyebrow(s) replacement following a burn injury or tumor removal as in craniotomy). 22. Otoplasty (ear pinning) for absent or deformed ears such as microtia (small, abnormally shaped or absent external ears) or anotia (total absence of the external ear and auditory canal) with functional deficiencies resulting from trauma, surgery, disease or congenital defect when performed to improve hearing by directing sound into the ear canal. 23. Nasal surgery that is performed to repair and improve documented and significant respiratory function, repair deficits caused by trauma, correct congenital anatomic abnormalities, revise structural deformities produced by trauma or nasal cutaneous disease, or replace nasal tissue lost after tumor ablative surgery (e.g., nasal fracture, benign or malignant neoplasms, deviated nasal septum, congenital musculoskeletal deformities, nasal sinus infection or fistula). Rhinoplasty (nose reshaping) when airway obstruction from deformities due to disease, congenital abnormality or trauma will not respond to septoplasty alone. 24. Pectus excavatum repair when documented functional impairment exists (i.e., decreased cardiac output and/or abnormal pulmonary function during exercise) Cosmetic and Reconstructive Surgery Dec 15 3

4 or when future cardiovascular compromise is anticipated. (i.e. Nuss procedure* could be used for this repair in mid-late childhood through young adult) 25. Abdominoplasty (tummy tuck)/panniculectomy may be considered reconstructive when the pannus causes recurrent, severe intertrigo/cellulitis that has not responded to conservative treatments including adequate hygiene, topical antiinfective medications and oral antibiotics see National Medical Policy for Abdominoplasty. 26. Breast implant for Poland s syndrome (congenital absence of breast). *Note: Health Net, Inc. considers the Nuss procedure, a minimally invasive repair for pectus excavatum for mid-childhood patients through young adults, medically necessary when all of the following criteria are met: A chest CT scan shows that the pectus index (transverse diameter divided by the anterior-posterior diameter), which is also known as the Haller index, is greater than Cardiac imaging studies such as MRI, echocardiography, or stress echocardiography indicate that the deformity is causing cardiac compression. Complications arising from the sternal deformity have been adequately documented. (i.e., asthma, frequent infections of the lower respiratory tract, atypical chest pain, exercise limitation, and/or cardiopulmonary impairment documented by cardiac function and/or respiratory function tests) Breast Reconstruction (Please refer to Medical Policy, Breast Reconstruction Surgery ) Not Medically Necessary Health Net, Inc. considers the following not medically necessary when used in association with breast reconstruction procedures, since there is a lack of randomized, controlled, prospective studies evaluating their efficacy: 1. Permacol 2. Radiesse Cosmetic Procedures Health Net, Inc. considers any of the following cosmetic in nature: 1. Cosmetic surgery performed purely for the purpose of enhancing one s appearance, and/or expenses incurred in connection with such surgery 2. Cosmetic surgery performed to treat psychiatric or emotional distress, problems or disorders 3. Dermabrasion, chemical peel, liquid nitrogen, skin grafting, dry ice or CO2 snow 4. Flesh color tattooing for the treatment of port wine stains, hemangiomas or birth marks 5. The intense pulsed light sources (IPLS; e.g., PhotoDerm VL) as initial therapy for treatment of port wine stains, hemangiomas, spider angiomas, cherry angiomas and facial telangiectasias 6. Septoplasty performed solely to improve the patient s appearance in the absence of any signs and/or symptoms of functional respiratory abnormalities 7. Rhinoplasty for external nasal deformity not due to trauma or disease (non covered services) 8. Mastopexy (breast lift) to treat sagging of the breast Cosmetic and Reconstructive Surgery Dec 15 4

5 9. Removal or revision of a breast implant for non-medical reasons 10. Surgery to correct a condition of moon face which developed as a side effect of cortisone therapy 11. Otoplasty (ear pinning) for lop ears, bat ears or prominent or protruding ears without functional deficiencies 12. Injection of any filling material (collagen) including but not limited to collagen, fat or other autologous or foreign material grafts 13. Salabrasion 14. Rhytidectomy of face (face lift) for aging skin 15. Removal of fatty tissue by lipectomy (i.e. suction-assisted liposuction, lipoplasty) 16. Excision excessive skin, thigh, leg, hip, buttock, arm, forearm or hand, submental fat pad, other areas 17. Electrolysis or laser hair removal 18. Correction of inverted nipples 19. Sclerosing of spider veins and/or telangiectasis 20. Excision/correction of glabellar frown lines 21. Otoplasty for large or protruding ears without hearing loss such that surgery will not improve hearing 22. Hair transplants to correct male pattern baldness (alopecia) or age related hair thinning in women because hair serves little or no functional purpose 23. Ear piercing 24. Facial rejuvenation/plumping/collagen or fat injections 25. Buttock or thigh lifts 26. Neck tucks 27. Chin implant for deformity not the result of disease or trauma 28. Epidural chemical peels used to photoaged skin, wrinkles, or acne scarring 29. Cryotherapy for acne 30. Dermal chemical peel used as treatment of end-stage acne scarring 31. Dermabrasion for wrinkling, pigmentation or severe acne scarring 32. Chemical exfoliation for acne 33. Laser resurfacing for wrinkling, aging skin, or telangectasias resulting from rosacea 34. Electrolysis or laser for hirsutism 35. Insertion or injection of prosthetic material to replace absent adipose tissue 36. Augmentation or enlargement (augmentation Mammoplasty) of small but otherwise normal breasts 37. Phalloplasty (penis enlargement) 38. Diastasis recti repair in the absence of a true midline hernia without evidence of current or potential incarceration, volvulus, or strangulation of bowel 39. Excision/treatment of decorative tattoos 40. Repair/revision of vaccination scars 41. Salabrasion 42. Reduction of labia minor 43. Collagen implant (e.g. Zyderm) 44. Gynecomastia surgery (See National Medical Policy on Gynecomastia) 45. Earlobe repair to close a stretched pierce hole 46. Pectus excavatum or pectus carinatum repair in an asymptomatic patient or to relieve emotional stress 47. Surgery to change the appearance of a child with Downs Syndrome 48. Vestibuloplasty 49. Vermilionectomy (lip shave), with mucosal advancement Cosmetic and Reconstructive Surgery Dec 15 5

6 Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes (List is not all inclusive) Hemangioma of skin and subcutaneous tissue [face and neck] Vascular hamartomas (e.g., Port-wine stain, strawberry nevus and birthmarks) [face and neck] ICD -10 Codes D18.01 Hemangioma of skin and subcutaneous tissue Q82.5 Congenital non-neoplastic nevus CPT Codes (List is not all inclusive) Tattooing, intradermal,introduction of insoluble opaque pigments to correct color defects of skin, including micropigmentation; 6.0 sq cm or less Tattooing, intradermal,introduction of insoluble opaque pigments to correct color defects of skin, including micropigmentation; 6.1 to 20.0 sq cm Tattooing, intradermal,introduction of insoluble opaque pigments to correct color defects of skin, including micropigmentation; each additional 20.0 sq cm or part thereof (List separately in addition to code for primary procedure) Subcutaneous injection or filling material 1cc or less Subcutaneous injection or filling material 1.1 cc to 5.0 cc Subcutaneous injection or filling material 5.1 cc to 10.0 cc Subcutaneous injection or filling material over 10.0 cc Insertion of tissue expander(s) excluding breast, including subsequent expansion Punch graft for hair transplant; 1 to 15 punch grafts Punch graft for hair transplant; more than 15 punch grafts Dermabrasion, total face Dermabrasion, segmental, face Dermabrasion, regional, other than face Dermabrasion, superficial Abrasion; single lesion Abrasion; each additional 4 lesions or less Chemical peel, facial; epidermal Chemical peel, facial; dermal Chemical peel, nonfacial; epidermal Chemical peel, nonfacial; dermal Destruction of cutaneous vascular proliferative lesions (eg, laser technique); less than 10 sq cm Cosmetic and Reconstructive Surgery Dec 15 6

7 17107 Destruction of cutaneous vascular proliferative lesions (eg, laser technique); 10.0 to 50.0 sq cm Destruction of cutaneous vascular proliferative lesions (eg, laser technique); over 50.0 sq cm Chemical cauterization Electrolysis epilation Vermilionectomy (lip shave), with mucosal advancement Vestibuloplasty; anterior Vestibuloplasty; posterior, unilateral Vestibuloplasty; posterior, bilateral Vestibuloplasty; entire arch Vestibuloplasty; complex (including ridge extension, muscle repositioning) Unlisted special dermatological service or procedure HCPCS Codes N/A Scientific Rationale Update December 2015 Barber et al (2015) reported the use of acellular dermal matrix (ADM) has transformed the technique of implant-based breast reconstruction. It offers the option of a one-stage procedure and is felt to have benefits in cosmetic outcome but the medium and long-term outcomes are unknown. All cases where ADM was used in a breast reconstructive procedure in the Edinburgh Breast Unit from its initial use on 7/7/2008 to 31/7/2012 were reviewed retrospectively. Follow up was completed to 30/11/ patients received 232 sheets of ADM (156 Strattice, 73 Permacol and 3 Alloderm). Mean follow up was 687 days. In 40 cases unplanned implant explantation occurred (17.2% or 27.2% of patients). 7 of 27 (25.9%) patients requiring adjuvant therapy had this delayed due to problems with the reconstruction. 30 of 80 patients (37.5%) undergoing unilateral surgery have undergone contralateral surgery. Implant loss varied significantly with smoking (34.6% loss rate in smokers vs 13.2% in non-smokers, p = 0.001), with radiotherapy (28.1% loss rate vs 13.8% with no radiotherapy, p = 0.001) and with incision type. There was no statistically significant variation by operating surgeon, type of ADM used, chemotherapy use, patient weight, breast weight or nipple preservation. Patients underwent a mean of 1.54 further operations (range 0-7). The authors concluded while offering potential cosmetic and financial benefits, the use of ADM with implantbased reconstructions has a significant rate of implant loss, further surgery and potential delay in adjuvant therapy. These must be considered when planning treatment and consenting patients. Scientific Rationale Update September 2012 Claro et al (2012) conducted a systematic review of the clinical applicability and safety of autologous fat grafting to the breast for cosmetic and reconstructive purposes. Studies included in the review were original articles of autologous liposuctioned fat grafting to the female breast, with description of clinical complications and/or radiographic changes and/or local breast cancer recurrence. The review included 60 articles with 4601 patients. Thirty studies used fat grafting for augmentation and 41 for reconstructive procedures. The incidence of clinical complications, identified in 21 studies, was 3 9 per cent (117 of 3015); the majority were induration and/or palpable nodularity. Radiographic abnormalities occurred in Cosmetic and Reconstructive Surgery Dec 15 7

8 332 (13 0 per cent) of 2560 women (17 studies); more than half were consistent with cysts. Local recurrence of breast cancer (14 of 616, 2 3 per cent) was evaluated in three studies, of which only one was prospective. Reviewers concluded there is broad clinical applicability of autologous fat grafting for breast reconstruction. Complications were few and there was no evidence of interference with follow-up after treatment for breast cancer. Oncological safety remains unclear. Pérez-Cano et al (2012) reported results of the RESTORE-2, the first prospective clinical trial using autologous adipose-derived regenerative cell (ADRC)-enriched fat grafting for reconstruction of such defects. This single-arm, prospective, multi-center clinical trial enrolled 71 patients post- breast conservation therapy (BCT) with defects 150 ml. Adipose tissue was collected via syringe lipoharvest and then processed during the same surgical procedure using a closed automated system that isolates ADRCs and prepares an ADRC-enriched fat graft for immediate reimplantation. ADRC-enriched fat graft injections were performed in a fan-shaped pattern to prevent pooling of the injected fat. Overall procedure times were less than 4 h. The RESTORE-2 protocol allowed for up to two treatment sessions and 24 patients elected to undergo a second procedure following the six month follow-up visit. Of the 67 patients treated, 50 reported satisfaction with treatment results through 12 months. Using the same metric, investigators reported satisfaction with 57 out of 67 patients. Independent radiographic core laboratory assessment reported improvement in the breast contour of 54 out of 65 patients based on blinded assessment of MRI sequence. There were no serious adverse events associated with the ADRC-enriched fat graft injection procedure. There were no reported local cancer recurrences. Injection site cysts were reported as adverse events in ten patients. Investigators concluded the prospective trial demonstrates the safety and efficacy of the treatment of BCT defects utilizing ADRC-enriched fat grafts. Kijima et al (2012) investigated 22 breasts in 21 patients who underwent partial mastectomy for early breast cancer involving mainly the inner upper quadrant were enrolled in this study. The defect was reconstructed immediately by filling it with an autologous free dermal fat graft (FDFG). At 6 months and 1, 2, 3, 4, and 5 years postoperatively, the width (horizontal length) and thickness (distance perpendicular to skin) of the FDFG on computed tomography (CT) scans were measured. Histologic samples from the implanted FDFG were collected by core needle biopsy (CNB). The correlations between clinical findings and volume of the FDFG on CT and the proportion of fatty tissue in the CNB were examined statistically. Cosmetic results were also evaluated. On CT, the mean width of the FDFG was 95%, 81%, 79%, 73%, 68%, and 47% and the mean thickness were 125%, 121%, 120%, 115%, 104%, and 103% at 6 months, and 1-5 years postoperatively, respectively. In the CNB samples, the mean fatty tissue distribution was 76%, 63%, and 54% at 1 year, 1-4 years, and >4 years postoperatively, respectively. The percent change in the width of the FDFG at 6 months after the operation displayed a significant negative correlation with the postmenopausal period and a significant positive correlation with the maximum surgical margin. On CT, thickness was negatively correlated with the size of the resected breast tissue, and thickness of the implanted FDFG. No clinicopathologic factors or technical factors were related to FDFG outcome and the proportion of fat tissue in the CNB sample, except for axillary dissection. Nineteen of 21 patients had good to excellent cosmesis. Authors concluded FDFG implanted into breast defects after partial mastectomy undergo mild resorption and degeneration to fibrous tissue, but most patients have good to excellent cosmesis. Cosmetic and Reconstructive Surgery Dec 15 8

9 Scientific Rationale Update October 2011 Strattice Reconstructive Tissue Matrix is a xenographic tissue matrix derived from porcine dermis (LifeCell, 2010, FDA, 2007). According to the FDA 510(k) approval, LTM Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The FDA 510K Summary lists Permacol as one of the predicate devices on which this approval was based (FDA, 2007). There is a lack of evidence in the peer-reviewed literature supporting the efficacy of Strattice in breast reconstructive procedures. Permacol is a cross-linked porcine dermal collagen surgical mesh. It is an internal implant intended for use as a soft tissue patch to reinforce soft tissue where weakness exist and for the surgical repair of damaged or ruptured soft tissue membranes. Permacol is supplied in hydrated, ready to use sheets of various sizes. It comes in two thicknesses (1.0 mm and 1.5 mm) to address surgeon preference and the patient s clinical features. Evidence in the published, peer-reviewed scientific literature supporting the use of permacol in breast reconstruction is lacking and its role is unclear. Radiesse has been proposed to reshape nipples after reconstruction of the breast following mastectomy. Radiesse injections consist of very small, smooth calcium hydroxylapatite (CaHA) microspheres that are suspended in a water-based gel carrier. Radiesse has received PMA approval by the FDA as a medical device for subdermal implantation for two indications: correction of moderate to severe facial wrinkles and folds such as nasolabial folds and the correction of facial fat loss in people with human immunodeficiency virus (FDA, 2006c). There remains a lack of evidence in the peer reviewed published literature on the long term outcomes, safety and efficacy of Radiesse in breast reconstructive procedures.there also remains a lack of evidence in the peer reviewed published literature on the long term outcomes, safety and efficacy of Radiesse in breast reconstructive procedures. Autologous fat transplant (i.e., lipoinjection) has been proposed for use in for breast reconstruction procedures. Fat grafting to the breast has been discouraged since it has been reported that calcifications secondary to fat necrosis may mimic breast cancer or that radiological changes post fat grafting would obscure and delay the diagnosis of subsequent breast cancer. Optimal patient selection criteria have not been established through well-designed comparative clinical trials with long-term outcomes data. Scientific Rationale Update February 2011 Pectus excavatum is a type of birth defect caused by abnormal growth of the ribs and breastbone, which gives the chest a sunken appearance. It is estimated that this disorder occurs in 1 of every 300 to 400 births, with approximately 75% of cases affecting boys. In many patients with pectus excavatum, the altered shape of the chest does not affect function; however, in severe cases, this deformity restricts filling of the lungs and patients often have reduced exercise capacity. In addition, the heart is typically pushed to one side, patients usually have some compression of the upper chambers of the heart, and 20% to 60% of patients have improper closure of one of the valves in the heart. The Ravitch procedure is a surgical method for correcting pectus excavatum; however, it is invasive requiring breastbone and cartilage incisions followed by muscle and skin repair. Cosmetic and Reconstructive Surgery Dec 15 9

10 The Nuss procedure was developed 20 years ago with the goal of providing a simpler and less traumatic surgery to correct pectus excavatum. To perform this procedure, the surgeon makes two small incisions in the sides of the chest adjacent to the deepest point of the chest wall depression. Guided by an endoscope to visualize the operative site, the surgeon passes a specially designed clamp or introducer through the chest from one incision to the other, which lifts the breastbone. The surgeon then inserts a curved metal bar, which is rotated and adjusted so that it pushes the breastbone and ribs outward. Once the bar is positioned, stabilizers are sutured on to both ends, and the entire bar is sutured into place at other points in the chest tissues. The Ravitch technique is an invasive surgery that was introduced in 1949, and developed in the 1950s to treat the condition. This procedure involves creating an incision along the chest through which the cartilage is removed and the sternum detached. A small bar is then inserted underneath the sternum to hold it up in the desired position. The bar is left implanted until the cartilage grows back, typically about 6 months. The bar is subsequently removed in an outpatient procedure. The Ravitch technique is not widely practiced because it is so invasive. It is used at times in older patients, where the sternum has calcified, when the deformity is asymmetrical, or when the less invasive Nuss procedure has proven unsuccessful. Treatment for pectus excavatum can involve either invasive or non-invasive techniques or a combination of both, as noted above. Preoperatively, several tests are usually to be performed. These include, but are not limited to, a CT scan, pulmonary function tests, and cardiology exams. After a CT scan is taken the Haller index is measured. The patient's Haller is calculated by obtaining the ratio of the transverse diameter (the horizontal distance of the inside of the ribcage) and the anteroposterior diameter (the shortest distance between the vertebrae and sternum). A Haller Index of greater than 3.25 is generally considered severe, while normal chest has an index of 2.5. Cardiac imaging studies such as MRI, echocardiography, or stress echocardiography indicate that the deformity is causing cardiac compression. Kelly et al. (2008) completed the largest available prospective, multicenter, nonrandomized controlled trial of the Nuss procedure. For this study, early outcomes were reported for patients who underwent the Nuss procedure (Nuss Group: n=284, mean age 13.6 years) versus patients who underwent open surgery (Open Group: n=43, mean age 15.9 years). All patients had severe pectus excavatum. The difference between the groups in mean age at baseline was statistically significant (P<0.05) and other demographics for the treatment groups were not reported separately. There were no statistically significant differences between the Nuss and Open Groups in mean postoperative pain scores. Differences between the groups in the incidence of specific complications occurring within 30 days after surgery were not statistically significant except for pleural effusion, which occurred in 92 (32%) Nuss Group patients versus 2 (5%) Open Group patients. Initial outcomes were classified as excellent in 91% of Nuss Group patients versus 67% of Open Group patients; however, it was not reported whether this difference was statistically significant. Other complications that occurred during and after the Nuss procedure were atelectasis in 141 (50%) patients, Horner s syndrome in 20 (7%), pneumothorax in 12 (4%), bar shift in 7 (2%), wound infection in 5 (2%), skin rash in 4 (1%), hematoma in 2 (1%), stitch abscess in 2 (1%), and bar reaction in 1 Cosmetic and Reconstructive Surgery Dec 15 10

11 (0.4%). No deaths occurred in either treatment group and no other postoperative outcomes were reported. Results of the available controlled studies provide evidence that the Nuss procedure and open surgical techniques have similar safety and efficacy for treatment of symptomatic pectus excavatum. Although some of the studies found that the Nuss procedure was associated with statistically significant reductions in operative time and blood loss, this advantage seems to be offset by an increase in postoperative pain or analgesic use. A shortcoming of the available studies is that most of them failed to report the quality of the chest reshaping in terms of appearance and none of them examined the degree of relief of cardiac and lung compression. The available controlled studies did not evaluate the incidence of recurrence of pectus excavatum after bar removal; however, a large uncontrolled study found that it was only 1.4% after 2.3 years of follow-up. Two other large uncontrolled studies reported 0% to 0.5% recurrence but did not report the duration of follow-up after bar removal. The overall quality of the available evidence is low; however, this evidence suggests that the Nuss procedure is efficacious and reasonably safe and is considered to be a standard treatment for symptomatic pectus excavatum. The National Institute of Clinical Excellence (NICE, 2009) guidance on the Nuss procedure states that there is sufficient evidence of the safety and efficacy of this procedure to support its use, assuming that it is performed with normal levels of clinical governance, auditing, and consent. The NICE has also specified the following criteria concerning the Nuss procedure: Patients can undergo this procedure in mid to late childhood. It should only be performed by surgeons who have training and experience in cardiac and thoracic surgery, specific training and mentoring in this technique, and capacity to manage liver or cardiac injury. Facilities used to perform this procedure should be adequate for performing the technique and managing all potential complications. Scientific Rationale Update June 2009 Port Wine Stains The International Society for Study of Vascular Anomalies, based on the work of Mulliken and Glowacki, (1982) classified two types of vascular anomalies: vascular malformations and vascular tumors. Port wine stains (PWSs) are common pediatric lesions that are vascular capillary malformations (CM) characterized by enlarged and dilated venules and capillaries in the superficial dermis, which can extend into deeper vessels of the dermis and subcutaneous tissues. At birth, the lesions typically appear as flat, faint, pink macules. With increasing age, they darken and become raised, red-to-purple nodules and papules in adults. According to the American Academy of Dermatology (AAD), port-wine stains (PWS) are congenital vascular malformations, which occur primarily on the face and neck, and affect approximately 0.3% to 0.5% of newborns. These chronic lesions are also found on extremities, but can arise anywhere on the body and are of varying sizes. Due to their potential for disfigurement, PWS can cause negative emotional and social consequences. Therefore, early treatment is usually recommended in order to prevent enlargement, to improve the patient s appearance, and to reduce the likelihood of medical complications. While many different types of treatments have been investigated for PWS, such as excision and grafting, dermabrasion, cryotherapy, sclerotherapy, tattooing, irradiation, and laser therapy, none is entirely Cosmetic and Reconstructive Surgery Dec 15 11

12 satisfactory and most have unacceptable side effects, including bleeding, pain, scarring, and risk of malignant transformation. Currently, per the Society for Pediatric Dermatology (2003), and the American Academy of Dermatology (2008), the pulsed dye laser (PDL) is considered the gold standard for port wine stain (PWS) treatment, and has been used as an alternative to surgical excision or carbon dioxide lasers. PDL, introduced in 1985, emits one specific color, or wavelength, of light that can be varied in its intensity and pulse duration. The hemoglobin within dilated or enlarged blood vessels comprising cutaneous vascular lesions, preferentially absorbs the energy from the PDL and generates heat, leading to the thermal destruction of the lesion, while sparing normal surrounding tissues. PDL therapy is administered in multiple sessions in an outpatient setting, with or without topical, local, or general anesthesia. Cryogen spray cooled PDL (CPDL) involves the application of a cryogen spurt to the skin surface milliseconds prior to laser irradiation. This cools the epidermis without affecting the deeper PWS blood vessels, and reduces the thermal injury sustained by the skin during laser treatment. Results from reviewed studies indicate that pulsed dye laser (PDL) therapy for PWS can produce a better blanching response with fewer side effects than either the copper vapor laser or the argon-pumped continuouswave dye laser. In addition, the pulsed-dye lasers provide several changes in parameters, including longer pulse duration of 1500 milliseconds versus the old 450-microsecond setting. This longer pulse duration appears to allow better penetration of tissue. The cooling hand pieces now available allow the use of higher fluences with less damage to tissue and less pain. It is unclear whether the newer 595-nm wavelength is superior to the 585-nm setting, although many believe it penetrates better. However, a retrospective study by Chang et al. (2002) evaluating 64 Asian patients receiving either 585-nm or 595-nm treatments provided evidence that improvement of portwine stains occurred with a 585-nm setting. The American Academy of Dermatology [AAD] (2004) propose early treatment will prevent the progression of development to hypertrophy and nodules in later years. Furthermore, it has been noted port wine stain lesions on the forehead or eyelids can lead to glaucoma in some patients. Various studies have been completed on pulsed dye laser for the treatment of port wine stains, including reviews by Friedlander (2003), and Jasim (2007); and case series by Geronemus (2000), Ahcan (2004), Tanghetti (2005), and Huikeshoven (2008). Pulsed dye laser therapy has been shown to be the most effective treatment for port wine stains, is associated with less adverse effects, and is considered the standard treatment of choice (Yang, et al., 2005; Schmults, 2005). Authors have reported that pulsed dye laser produces fewer side effects than the copper vapor laser or the argon pumped continuous wave laser. Pulsed-dye laser therapy offers the most successful treatment modality in fading these lesions, and studies demonstrate that efficacy is increased if treated in infancy, although size and location are also predictors of outcome (Conlon, Drolet, 2004). The pulsed-dye laser has been associated with less postoperative scarring. Nonetheless, while most port wine stains lighten after a series of pulsed dye laser treatments, some cannot be completely removed (Yang, et al., 2005). Cosmetic and Reconstructive Surgery Dec 15 12

13 For Port-Wine Stains (PWS), 3 randomized and 9 nonrandomized comparative studies were available that met the inclusion criteria for review. Only 2 of these studies (Chang and Nelson, 1999; Chang et al., 2002) compared different treatments in distinct patient groups, using concurrent or historical controls, whereas the other 10 studies examined the effects of various therapies on test sites within PWS on the same patients. Sommer et al. (2000) The outcomes reported in the reviewed studies indicate that CPDL therapy is safe and efficacious for clearing PWS in infants, children, or adults who require definitive treatment for clinically significant or disfiguring lesions. Satisfactory clearing of most PWS can be accomplished with multiple treatment sessions. While the response of dark-skinned patients to PDL therapy for PWS is poorer and associated with increased risks of hyperpigmentation and scarring, compared with light-skinned patients, the benefits of the procedure outweigh the risks in most cases. Patients should be fully apprised of the limited efficacy and possible complications related to this skin type prior to therapy. While many PDL procedures are performed with no anesthesia or with local anesthesia, the anesthetic requirements for each patient should be carefully evaluated. For example, young children with large lesions or lesions situated at sites that are more likely to elicit pain may require general anesthesia. The impact of repetitive, painful treatments for young children must be considered and weighed against the risks of anesthesia. Alternatively, treatment may be deferred until the child is older and more able to tolerate the discomfort associated with PDL. Outcome measures included degree and rate of lesion clearing, number of treatments required to clear lesions, patient satisfaction, and complications. The response of PWS to treatment is defined as the degree of lesion clearing, lightening, or fading, namely, the reduction in the difference in color between a PWS and normal surrounding skin. Outcomes were assessed in most studies by subjective methods, i.e., clinical examination, comparison of pretreatment and post-treatment photographs, and patient reports, although skin reflectance spectrophotometry was occasionally used. The absorbance index (AI), measured by a skin reflectance spectrophotometer, is an objective method of assessing vascular lesions that determines the amount of light absorbed by treated skin and, hence, their degree of lightening (Katugampola et al. 1997; Sommer et al. 2000). Since measurement of lesion clearing is often subjective and there is no universally accepted method of quantifying changes in PWS coloration, the outcome measures reported by the included studies were very heterogeneous. A lack of controlled studies with a single parameter difference has made it difficult to verify the best settings for pediatric PWS treatment. A larger spot size produces a better outcome, as the laser beam can penetrate deeper into the lesion. It is generally agreed that, in order to improve the outcome of PDL therapy, additional randomized controlled trials are needed to clarify the variables that predict the response to this therapy, including age, gender, skin type, lesion site, and lesion histopathology and morphology. A safe and noninvasive method for predicting outcomes is needed so that the PDL protocol can be optimized (dose, timing, number of treatment sessions, etc.), which would lead to better response rates and possibly reduce the number of treatments required. For example, this might be accomplished with the development and implementation of more objective techniques, such as videomicroscopy and color-coded duplex sonography, to evaluate lesion Cosmetic and Reconstructive Surgery Dec 15 13

14 histopathology, morphology, and blood vessel patterns and depth, instead of a reliance on macroscopic appearance of PWS. Intense Pulsed Light Sources Intense pulsed light sources (IPLS) have been used recently for port wine stain (PWS) treatment not only due to their broader wavelength span which covers more than one absorption peak of hemoglobin, but also their larger spot size, and less purpura formation. Drosner et al. (2008) completed an open 4-year prospective study to evaluate the clearing efficacy of second generation intense pulsed light sources (IPLS) compared with pulsed dye laser (PDL) for the treatment of PWS. One hundred patients (69 females, 31 males, aged years, average 23.4±14.9 years) with 130 PWS areas were included in the study. 64% of the patients had not been treated before. Each port wine stain was divided into pairs of equally red areas at the same localization. The treatment was repeated at 6 8 weekly intervals until one side showed improvement (partial or complete clearing) or caused side effects. Superior clearing of PWS by IPLS was found in 57.7% of the treated areas and this result is statistically significant (P<0.0005), whereas superior clearing of PDL was found to be 13.8%. No difference between treatment methods was found in 28.5% of the cases which included 6.9% of all treated PWS locations found to be non-responding to both treatment options. The superiority of IPLS clearing was also evident in the age subgroups, showing statistically significant differences in three of the four age groups. Fifty-nine percent of the patients or their parents decided to continue the PWS treatment with IPLS, whereas 19% preferred to continue with PDL. Other than purpura, the long-term adverse events following PDL treatment were hyperpigmentation and hypopigmentation, which occurred in 12 and three areas, respectively. By comparison, burns occurred in four areas after IPLS, two of them were caused by treatment of brown skin and one resulted from treatment of a lentigo within the PWS. IPL technology proved to be superior in clearing PWS and was preferred by the patients for continuing treatment compared with PDL as long as it was used in non-tanned patients. Scientific Rationale Initial Plastic surgery is the surgical specialty that deals with the reshaping or remolding of facial and body tissue in order to approximate a normal appearance or to repair functional ability lost due to disease, a congenital defect, or trauma. Plastic surgery restores and improves function, as well as appearance. It can involve surgery on any portion of the anatomy, except the central nervous system. According to the American Society of Plastic and Reconstructive Surgeons, the specialty of plastic surgery included two types of procedures: (1) reconstructive surgery is performed on abnormal structures of the body, caused by congenital defects, developmental abnormalities, trauma, infection, tumors, involutional defects, or disease. It is generally performed to improve function; and (2) cosmetic (aesthetic) surgery is performed to reshape normal structures of the body in order to improve the patient s appearance and self-esteem. It s estimated that more than one million reconstructive procedures are performed by plastic surgeons in the USA every year. Reconstructive surgery helps patients of all ages and types whether it s a child with a birth defect, a hound adult injured in an accident, or an older adult with a problem caused by aging. Generally, two types of patients have reconstructive surgery: (1) patients with birth defects; or (2) Cosmetic and Reconstructive Surgery Dec 15 14

15 patients with developmental deformities. Some common examples of congenital abnormalities are cleft-lip and palate deformities, such as syndactyly (webbed fingers) or extra or absent fingers. Burn wounds, lacerations, growths and aging problems are considered acquired deformities. Cosmetic plastic surgery is performed in order to change one s appearance. For some it may mean redesigning the body s contour and shape, the elimination of wrinkles, of eliminating balding areas. Others may choose varicose vein treatment or breast augmentation. In any event, there are a number of cosmetic surgery procedures that men and women can choose from in order to create an image that makes them feel more confident and comfortable with their appearance. An estimated 1 million cosmetic procedures were performed in 1998 a 50 percent increase from the year before. And it is not just women who are opting to enhance their appearance through surgery. Statistics show that the number of men having liposuction has tripled since In addition, the number of men having facelifts has almost doubled. Review History October 2004 Medical Advisory Council, initial approval July 2005 Expanded #10 to include keloids; added criterion #11 September 2006 Laser therapy of port wine stains considered medically necessary and added criterion #8 about hemangiomas Clarified #3, 4, and 5 under Cosmetic Procedures March 2008 Added pectus carinatum repair in an asymptomatic patient or to relieve emotional stress to the not medically necessary/cosmetic list September 2008 Added CA Reconstructive Surgery law disclaimer June 2009 Update. Revised policy. Added Pulsed to laser therapy to #6 on pg. 1 and #7 on pg. 2, to reflect current guidelines that pulsed laser therapy is gold standard for port wine stains. Codes updated. February 2011 Update. Added Medicare Table. Added Nuss procedure to be used for repair of pectus excavatum in mid-childhood through young adults as medically necessary. March 2011 Added information from the Breast Reconstructive Surgery Policy October 2011 Update. No revisions. September 2012 Update No revisions April 2012 Removed all reference to breast reconstruction from the policy- please refer to separate policy, Breast Reconstruction Surgery for information and criteria September 2013 Update no revisions. Code updates September 2014 Update no revisions December 2014 Added procedures/codes for prior authorization in January 2015 (Vestibuloplasty, Vermilionectomy, tissue expanders) December 2015 Update no revisions This policy is based on the following evidence-based guidelines: 1. American Society of Plastic And Reconstructive Surgeons. Position Paper. Breast Reconstruction. June Cosmetic and Reconstructive Surgery Dec 15 15

16 2. American Society of Plastic and Reconstructive Surgeons. Position Paper. Cutaneous Laser Surgery. January American Society of Plastic and Reconstructive Surgeons. Position Paper, Ear Deformity: Prominent Ears. January American Society of Plastic and Reconstructive Surgeons. Position Paper, Reoperation of Women with Breast Implants. June Institute for Clinical Systems Improvement (ISCI). Acne management. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); Hayes. Health Technology Brief. Nuss Procedure for Pectus Excavatum in Children. December 31, Archived Jan National Institute for Health and Clinical Excellence (NICE). Placement of pectus bar for pectus excavatum (also known as MIRPE or the Nuss procedure). August 26, References Update December Barber MD, Williams L, Anderson ED, et al. Outcome of the use of acellulardermal matrix to assist implant-based breast reconstruction in a single centre. Eur J Surg Oncol Jan;41(1): References Update September Gold MH, Berman B, Clementoni MT, et al. Updated international clinical recommendations on scar management: part 1-evaluating the evidence. Dermatol Surg Aug;40(8): References Update September Beale EW, Hoxworth RE, Livingston EH, Trussler AP. The role of biologic mesh in abdominal wall reconstruction: a systematic review of the current literature. Am J Surg Oct;204(4): Ibrahim AM, Ayeni OA, Hughes KB, et al. Acellular dermal matrices in breast surgery: a comprehensive review. Ann Plast Surg Jun;70(6): Slavin SA, Lin SJ. The use of acellular dermal matrices in revisional breast reconstruction. Plast Reconstr Surg Nov;130(5 Suppl 2):70S-85S References Update September Claro F Jr, Figueiredo JC, Zampar AG, Pinto-Neto AM. Applicability and safety of autologous fat for reconstruction of the breast. Br J Surg Jun;99(6): de Blacam C, Momoh AO, Colakoglu S, et al. Evaluation of clinical outcomes and aesthetic results after autologous fat grafting for contour deformities of the reconstructed breast. Plast Reconstr Surg Nov;128(5):411e-418e. 3. Khouri RK, Eisenmann-Klein M, Cardoso E, et al. Brava and autologous fat transfer is a safe and effective breast augmentation alternative: results of a 6- year, 81-patient, prospective multicenter study. Plast Reconstr Surg May;129(5): Kijima Y, Yoshinaka H, Hirata M, et al. Clinical and pathologic evaluation of implanted free dermal fat grafts after breast cancer surgery: a retrospective analysis. Surgery Mar;151(3): Pérez-Cano R, Vranckx JJ, Lasso JM, et al. Prospective trial of adipose-derived regenerative cell (ADRC)-enriched fat grafting for partial mastectomy defects: the RESTORE-2 trial. Eur J Surg Oncol May;38(5): Cosmetic and Reconstructive Surgery Dec 15 16

17 References Update October LifeCell Corporation. Strattice Nahabedian M. Breast reconstruction in women with breast cancer. June 9, Breast reconstruction in women with breast cancer. 2. Synthesis North America. DermaMatrix Acellular Dermis Accessed July 22, References Update February Antonoff MB, Erickson AE, Hess DJ, et al. When patients choose: comparison of Nuss, Ravitch, and Leonard procedures for primary repair of pectus excavatum. J Pediatr Surg. 2009;44(6): Kelly RE Jr, Shamberger RC, Mellins RB, et al. Prospective multicenter study of surgical correction of pectus excavatum: design, perioperative complications, pain, and baseline pulmonary function facilitated by internet-based data collection. J Am Coll Surg. 2007;205(2): CMS. Centers for Medicare & Medicaid. Article for COSMETIC</span></strong> vs. RECONSTRUCTIVE SURGERY (A47274). Noridian Administrative Services, LLC CMS. Centers for Medicare & Medicaid. Article for COSMETIC</span></strong> vs. RECONSTRUCTIVE SURGERY (A47276). 3/6/2008. Noridian Administrative Services, LLC. References Update May Pielop JA. Vascular lesions in the newborn. UpToDate. October 4, Drosner M, Ellwanger J, Schöttle K, et al. Comparison of intense pulsed light (IPL) and pulsed dye laser (PDL) in port-wine stain treatment. Medical Laser Application. Volume 23, Issue 3, 20 August 2008, Pages Stier MF, Glick SA, Hirsch RA. Laser treatment of Pediatric Vascular Lesions. Journal of the American Academy of Dermatology. Volume 58, Issue 2, February Huikeshoven M, Koster PH, de Borgie CA, et al. Redarkening of port-wine stains 10 years after pulsed-dye-laser treatment. N Engl J Med Jasim ZF, Handley JM. Treatment of pulsed dye laser resistant port wine stain birthmarks. Journal of the American Academy of Dermatology 6. Volume 57, Issue 4, October 2007, Pages Burstein FD, Williams JK, Schwentker AR, et al. Intralesional laser therapy treatment for hemangiomas: technical evolution. J Craniofacial Surgery Tomson N, Lim SP, Abdullah A, et al. The treatment of port-wine stains with the pulsed-dye laser at 2-week and 6-week intervals: a comparative study. Br J Dermatol. 2006; 154 (4): Hayes. Medical Technology Directory. Pulsed Dye Laser Therapy for Cutaneous Vascular Lesions. January 27, Yang MU, Yaroslavsky AN, Farinelli WA, et al. Long-pulsed neodymium:yttriumaluminum-garnet laser treatment for port-wine stains. J Am Acad Dermatol. 2005;52(3 pt 1): Tanghetti EA, Sherr E, Sierra R, et al. Sequential 595 nm, 1064 nm laser treatment for blebbed portwine stains and leg veins. Lasers Surg Med Smit JM, Bauland CG, Wijnberg DS, et al. Pulsed dye laser treatment, a review of indications and outcome based on published trials. Br J Plast Surg. 2005;58(7): Cosmetic and Reconstructive Surgery Dec 15 17

18 12. Yung A, Sheehan-Dare R. A comparative study of a 595-nm with a 585-nm pulsed dye laser in refractory port wine stains. Br J Dermatol. 2005;153(3): Yang MU, Yaroslavsky AN, Farinelli WA, et al. Long-pulsed neodymium:yttriumaluminum-garnet laser treatment for port-wine stains. J Am Acad Dermatol. 2005;52(3 pt 1): Greve B, Raulin C. Prospective study of port wine stain treatment with dye laser: comparison of two wavelengths (585 nm vs. 595 nm) and two pulse durations (0.5 milliseconds vs. 20 milliseconds). Lasers Surg Med. 2004;34(2): Ahcan U. Port wine stain treatment with a dual-wavelength Nd:Yag laser and cryogen spray cooling: a pilot study. Lasers Surg Med - 01-JAN-2004; 34(2): American Academy of Dermatology (AAD). Public resource center: vascular birthmarks American Osteopathic College of Dermatology (AOCD). Hemangiomas. 18. Friedlander SF. Clinical Characteristics of Vascular Anomalies. Society for Pediatric Dermatology 2003 Annual Meeting: Vascular Anomalies, Dermatologic Surgery, Tanning Parlors, and Insect Repellents. 10/22/ Tanzi EL, Lupton JR, Alster TS. Lasers in dermatology: four decades of progress. J Am Acad Dermatol Chang CJ, Kelly KM, Van Gemert et al. Comparing the effectiveness of 585-nm vs. 595-nm wavelength pulsed dye laser treatment of port wine stains in conjunction with cryogen spray cooling. Lasers Surg Med. 2002; 31 (5): Geronemus RG, Quintana AT, Lou WW, et al. High-fluence modified pulsed dye laser photocoagulation with dynamic cooling of port-wine stains in infancy. Arch Dermatol Sommer S, Sheehan-Dare RA. Pulsed dye laser treatment of port-wine stains in infancy: treatment of superficial vs mixed hemangiomas. Arch Dermatol. 2000;136(5): Poetke M, Philipp C, Berlien HP. Flashlamp-pumped pulsed dye laser for hemangiomas in infancy: treatment of superficial vs mixed hemangiomas. Arch Dermatol. 2000; 136 (5): Chang CJ, Nelson JS. Cryogen spray cooling and higher fluence pulsed dye laser treatment improve port-wine stain clearance while minimizing epidermal damage. Dermatol Surg. 1999;25(10): Katugampola GA, Lanigan SW. Five years experience of treating port wine stains with the flashlamp-pumped pulsed dye laser. Br J Dermatol. 1997;137(5): References Initial 1. Nottingham LK, Ries WR. Update on lasers in facial plastic surgery. Curr Opin Otolaryngol Head Neck Surg Aug 12(4): Batniji RK, Falk AN. Update on botulinum toxin use in facial plastic and head and neck surgery. Curr Opin Otolaryngol Head Neck Surg Aug; 12(4): Renner G, Lane RV. Auricular reconstruction: an update. Curr Opin Otolaryngol Head Neck Surg Aug; 12(4) Tindholt TT, Tonseth KA, Solberg US, et al. Breast reconstruction following mastectomy. Tidsskr Nor Laegeforen Jun 17; 124(12): Heppell PS. Plastic surgery. J R Army Med Corps Mar; 150(1): Martinick JH. The latest developments in surgical hair restoration. Facial Plast Surg Clin North Am May; 12 (2): Cosmetic and Reconstructive Surgery Dec 15 18

19 7. Bassichis BA, Swamy R, Dayan SH. Use of the KTP laser in the treatment of rosacea and solar lentigines. Facial Plast Surg Feb; 20(1): Evans GR. What s new in plastic and maxillofacial surgery. J Am Coll Surg Mar; 198(3): Hart D. Overcoming complications of breast implants. Plast Surg Nurs Summer; 23(2):55-63, Rohrich RJ, Janis JE, Fagien S. Stuzin JM. The cosmetic use of botulinum toxin. Plastic Reconstr Surg Oct; 112 (5 Suppl): 177S-88S; quiz 188S, 192S; discussion 189S-191S. 11. Rohrich RJ, Janis JE, Kenkel JM. Male rhinoplasty. Plast Reconstr Surg Sep 15;112 (4); ; quiz Sandelin K, King E. Redman S. Breast reconstruction following mastectomy: current status in Australia. ANZ J Surg Sep; 73 (9): Steward D, Mentzer RM Jr. Nasal reconstruction. J Ky Med Assoc Jul; 101(7): Alster T. Laser scar revision: Comparison study of 585-nm pulsed dye laser with and without intralesional corticosteroids. Dermatol Surg. 2003;29(1): Papadavid E, Katsambas A. Lasers for facial rejuvenation: A review. Int J Dermatol. 2003; 42(6): Johnson D, Whitworth IH. Recent developments in plastic surgery. BMJ Aug 10;325(7359): Tanzi EL, Alster TS. Treatment of atrophic facial acne scars with a dual-mode Er:YAG laser. Dematol Surg. 2003;28(7): Lee WP. What s new in plastic surgery. J AM Coll Surg Mar; 194(3): Strong EB, Buckmiller LM. Management of the cleft palate. Facial Plast Surg Clin North AM Feb; 9(1):15-25, vii. 20. Emery BE. Otoplasty. Facial Plast Surg Clin North Am Feb; 9 (1): Kwon SD, Kye YC. Treatment of scars with a pulsed Er: YAG laser. J Cutan Laser Ther. 2000; 2(1): Hoeyberghs JL. Fortnightly review: Cosmetic surgery. BMJ. 1999;318(7182): Kuzon WM Jr. Plastic surgery. J Am Coll Surg. 1999;188(2): Grover R, Sanders R. Plastic surgery. BMJ. 1998;317(7155): Amaral MJ. Plastic surgery or esthetic surgery? Acta med Port.1998;11(2): McClean K, Hanke CW. The medical necessity for treatment of port-wine stains. Dermatol Surg. 1997; 23(8): Mogelvang C. Cosmetic versus reconstructive surgery. Plast Reconstr Surg. 1997;99(7); Kucan JO, Lee RC. Plastic surgery. JAMA. 1996;275(23): Hallock GG. Cosmetic trauma surgery. Plastic Reconst Surg. 1995;95(2): Zook EG. Plastic surgery. JAMA. 1994; 271(21): Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, Cosmetic and Reconstructive Surgery Dec 15 19

20 including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. Coverage decisions are the result of the terms and conditions of the Member s benefit contract. The Policies do not replace or amend the Member s contract. If there is a discrepancy between the Policies and the Member s contract, the Member s contract shall govern. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery California Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Cosmetic and Reconstructive Surgery Dec 15 20