Easy Choice Health Plan, Inc. Exactus Pharmacy Solutions, Inc. Harmony Health Plan of Illinois, Inc. Missouri Care, Incorporated WellCare Health Insurance of Arizona, Inc., operating in Hawai i as Ohana Health Plan, Inc. WellCare of Kentucky, Inc. WellCare Health Plans of Kentucky, Inc. WellCare Health Plans of New Jersey, Inc. WellCare of Connecticut, Inc. WellCare of Florida, Inc., operating in Florida as Staywell WellCare of Georgia, Inc. WellCare of Louisiana, Inc. WellCare of New York, Inc. WellCare of South Carolina, Inc. WellCare of Texas, Inc. WellCare Prescription Insurance, Inc. Windsor Health Plan, Inc. Bunionectomy Policy Number: Original Effective Date: 10/1/2015 Revised Date(s): N/A APPLICATION STATEMENT The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Clinical Coverage Guideline page 1
DISCLAIMER The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: Lines of business (LOB) are subject to change without notice; current LOBs can be found at www.wellcare.com select the Provider tab, then Tools and Clinical Guidelines. BACKGROUND Hallux valgus (HV), with its accompanying bunion, is a common deformity of the forefoot involving the first ray, with first phalanx abduction and pronation, and first metatarsal adduction, pronation, and elevation, along with capsular and ligamentous derangement. Most bunions are treatable without surgery. Prevention is always best by choosing shoes that conform to the shape of the feet, have wide insteps, broad toes and soft soles. Patients should avoid shoes that are short, tight, sharply pointed, or with heels higher than 2¼ inches. If a bunion is already present, the patient should try protective pads to cushion the painful bunion and must wear well-fitting, low-heeled comfortable shoes that are roomy enough to not put pressure on it. 1 Deformities encountered in hallux valgus (HV) surgery involve the first metatarsophalangeal joint (MTPJ). However, when assessing this deformity, one must analyze the interphalangeal joint (IPJ), the first metatarsocuneiform (MTC) joint, the hindfoot, and the ankle. The deformity may involve all of these levels, which can affect the success of a chosen operation. Early in the disease, the medial supporting structures of the first MTPJ, the medial collateral ligaments and medial sesamoid, are typically the first structures to fail. Several other parts of the anatomy begin to fail as well. Once the medial supporting structures fail, the metatarsal head can move medially, off the sesamoid apparatus, and the proximal phalanx falls into a valgus position. The proximal phalanx remains attached by the deep transverse ligament and the adductor hallucis tendon. Once the metatarsal head has moved laterally over the sesamoid complex, the medial sesamoid can erode the crista and plantar-facing cartilage. The bursa over the medial aspect of the joint can thicken secondary to the increased pressure, worsening the condition. The extensor and flexor hallucis longus tendons are now in position to worsen the HV as they bowstring across the joint. The abductor hallucis attachments on the medial and plantar surface change position as the hallux pronates, and the force of the abductor hallucis then contributes to the pronation. 1 According to the textbook Campbell's Operative Orthopaedics, bunion deformities are divided into 3 stages: 2 Stage Characteristics IMA HVA Mild Small bunion; big toe may abut the 2nd toe < 12 o 21-30 o Moderate Moderate or large bunion; big toe abuts the 2nd toe or 12-16 o 31-40 o may push it to the side Severe Big toe may completely displace the 2nd toe; 2nd toe may sit on top of the big toe or vice versa > 16 o > 40 o In the United States, the number of forefoot operations for the 3 most common forefoot ailments (HV, hammertoe, and intermetatarsal perineural fibrosis) is markedly higher in females than in males. The prevalence of HV is markedly higher in females, with studies reporting a female-to-male ratio of 8-9:1 and even as high as 15:1. This discrepancy is attributed to differences in footwear. The peak age of onset of HV is from age 30-60 years, although it is likely that the initial changes occur during adolescence or even earlier in the case of juvenile HV. 1 POSITION STATEMENT Applicable To: Medicaid Medicare Clinical Coverage Guideline page 2
Exclusions Foot ulcer(s) secondary to peripheral vascular disease. Gangrene of the foot, ankle or lower leg. Non-ambulatory individuals unless being performed to relieve ulceration due to prominence. Open blisters, pressure sores, and skin ulceration overlying the bunion when the bunion is not the cause of the skin lesion (bony correction may lead to osteomyelitis). Poor tissues at the operative site due to excessive scarring and multiple closely placed previous incisions. Severe vascular insufficiency significantly impairing circulation to the foot (e.g., absent foot pulses, intermittent claudication, ankle/arm ratio less than 0.6). To improve the appearance of the foot (cosmetic). The use of allograft. Simple Bunionectomy Simple bunionectomy (e.g., modified McBride, Silver Procedure) with soft tissue removal of the bump only without bony correction is considered medically necessary and a covered benefit with either of the following conditions: Member presents with clinical symptoms, a hallux valgus angle (HVA) (formed by the long axis of the proximal phalanx and the first metatarsal) of 15 degrees or more with no degenerative changes at the meta-tarso-phalangeal (MTP) joint, and a history of conservative management failure; OR Member is diabetic with an ulcer and/or infection stemming solely from the bunion. Bony Correction Bunionectomy Bony correction bunionectomy (including Akin, Chevron, Keller, Lapidus, Mitchell, proximal metatarsal osteotomy procedures, etc.) is considered medically necessary and a covered benefit to treat symptomatic hallux valgus (bunion) in member s who are skeletally mature (after epiphyseal closure) or are 18 years of age or older. In addition, the member must meet item 1, 2, 3, 4, 5, or 6: 1. Member's pain and symptoms over the medial bony eminence or calluses persist, making walking difficult despite at least a 6-month trial of using protective pads, shoe inserts and alternative footwear that includes: o o o Wearing well-fitting, low-heeled comfortable shoes made out of soft materials (e.g., canvas, cloth, soft leather) with wide toe box and padding; OR Lace-ups or a combination last (front of the shoe is wider than the back of the shoe) that conforms to the bunion and minimizes irritation; AND Documented evidence of the most recent weight-bearing view X-ray demonstrating: Member has a hallux valgus angle (HVA)of 30 degrees or greater; AND An inter-metatarsal angle (IMA) (formed by the long axis of the first and second metatarsals) of 12 degrees or greater. 2. A neuroma secondary to the bunion. 3. Problems with a dorsiflexed second toe due to over-riding of the great toe (so-called cross-over toe deformity). 4. Recurrent bursitis. 5. Demonstration of osteoarthritis on X-ray, as evidenced by any of the following: Cysts in the metatarsal head; OR Loss of the cartilage space between the bones; OR Clinical Coverage Guideline page 3
Mild-to-moderate bony proliferative pathology. 6. The need for relief of a predisposing factor, e.g., Achilles tendon contracture. NOTE: Requests for bilateral bunionectomy done at the same time may require additional medical necessity review and may not be authorized. Bunionette Correction of a bunionette deformity (tailor's bunion) is considered medically necessary and a covered benefit when both of the following are met: Persistent pain despite a 6-month trial of conservative measures, including padding, debridement, nonsteroidal anti-inflammatory drugs (NSAIDs), orthotic therapy, and shoe modifications to ones that fit comfortably with a soft upper and a roomy toe box; AND The IMA is 10 degrees or greater and the MTP angle is 16 degrees or greater. Cheilectomy Foot cheilectomy is considered medically necessary and a covered benefit for symptomatic relief of either: Painful bony spurs in the earlier stages of an arthritic joint; or Painful hallux rigidus. Arthrodesis Arthrodesis (fusion) of the foot is considered medically necessary for any of the following: A hallux valgus deformity when the second toe is absent; OR Advanced hallux valgus (IMA greater than 20 degrees, HVA greater than 40 degrees); OR Failed bony correction bunionectomy (e.g., Keller bunionectomy); OR Failed cheilectomy; OR Painful symptoms secondary to hallux valgus with advanced degenerative joint disease; OR Severely subluxated or dislocated MTP joints. CODING Covered CPT Codes 28110 Ostectomy, partial excision, fifth metatarsal head (bunionette) (separate procedure) Hallux rigidus correction with cheilectomy, debridement and capsular release of the first 28289 metatarsophalangeal joint Correction, hallux valgus (bunion), with or without sesamoidectomy; simple exostectomy (eg. Silver 28290 type procedure) Correction, hallux valgus (bunion), with or without sesamoidectomy; Keller, McBride, or Mayo type 28292 procedure 28293 Correction, hallux valgus (bunion), with or without sesamoidectomy; resection of joint with implant Correction, hallux valgus (bunion), with or without sesamoidectomy; with tendon transplants (eg, 28294 Joplin type procedure) Correction, hallux valgus (bunion), with or without sesamoidectomy; with metatarsal osteotomy (eg, 28296 Mitchell, Chevron, or concentric type procedures) 28297 Correction, hallux valgus (bunion), with or without sesamoidectomy; Lapidus type procedure 28298 Correction, hallux valgus (bunion), with or without sesamoidectomy; by phalanx osteotomy 28299 Correction, hallux valgus (bunion), with or without sesamoidectomy; by double osteotomy Clinical Coverage Guideline page 4
Covered ICD-9 CM Volume 3 - Procedure Codes 77.51 Bunionectomy with soft tissue correction and osteotomy of the first metatarsal 77.52 Bunionectomy with soft tissue correction and arthrodesis 77.53 Other bunionectomy with soft tissue correction 77.54 Excision or correction of bunionette Covered ICD-10 PCS Procedure Codes GEM Combination 9 0MQS0ZZ 0Q8N0ZZ GEM Combination 12 0MQS3ZZ 0Q8N3ZZ GEM Combination 23 0MQS4ZZ 0Q8N4ZZ GEM Combination 30 0MQT0ZZ 0Q8P0ZZ GEM Combination 40 0MQT3ZZ 0Q8P3ZZ GEM Combination 53 0MQT4ZZ 0Q8P4ZZ GEM Combination 3 0MQS0ZZ 0SGM0ZZ GEM Combination 17 0MQS3ZZ 0SGM3ZZ GEM Combination 26 0MQS4ZZ 0SGM4ZZ GEM Combination 35 0MQT0ZZ 0SGN0ZZ GEM Combination 38 0MQT3ZZ Repair Right Foot Bursa and Ligament, Open Approach Division of Right Metatarsal, Open Approach Repair Right Foot Bursa and Ligament, Percutaneous Approach Division of Right Metatarsal, Percutaneous Approach Repair Right Foot Bursa and Ligament, Percutaneous Endoscopic Approach Division of Right Metatarsal, Percutaneous Endoscopic Approach Repair Left Foot Bursa and Ligament, Open Approach Division of Left Metatarsal, Open Approach Repair Left Foot Bursa and Ligament, Percutaneous Approach Division of Left Metatarsal, Percutaneous Approach Repair Left Foot Bursa and Ligament, Percutaneous Endoscopic Approach Division of Left Metatarsal, Percutaneous Endoscopic Approach Repair Right Foot Bursa and Ligament, Open Approach Fusion of Right Metatarsal-Phalangeal Joint, Open Approach Repair Right Foot Bursa and Ligament, Percutaneous Approach Fusion of Right Metatarsal-Phalangeal Joint, Percutaneous Approach Repair Right Foot Bursa and Ligament, Percutaneous Endoscopic Approach Fusion of Right Metatarsal-Phalangeal Joint, Percutaneous Endoscopic Approach Repair Left Foot Bursa and Ligament, Open Approach Fusion of Left Metatarsal-Phalangeal Joint, Open Approach Repair Left Foot Bursa and Ligament, Percutaneous Approach Clinical Coverage Guideline page 5
0SGN3ZZ GEM Combination 53 0MQT4ZZ 0SGN4ZZ GEM Combination 3 0MQS0ZZ GEM Combination 4 0MQS3ZZ GEM Combination 7 0MQS4ZZ GEM Combination 12 0MQT0ZZ GEM Combination 15 0MQT3ZZ GEM Combination 16 0MQT4ZZ Fusion of Left Metatarsal-Phalangeal Joint, Percutaneous Approach Repair Left Foot Bursa and Ligament, Percutaneous Endoscopic Approach Fusion of Left Metatarsal-Phalangeal Joint, Percutaneous Endoscopic Approach Repair Right Foot Bursa and Ligament, Open Approach Repair Right Foot Bursa and Ligament, Percutaneous Approach Repair Right Foot Bursa and Ligament, Percutaneous Endoscopic Approach Repair Left Foot Bursa and Ligament, Open Approach Repair Left Foot Bursa and Ligament, Percutaneous Approach Repair Left Foot Bursa and Ligament, Percutaneous Endoscopic Approach Covered ICD-9 CM Volume 1 - Diagnosis Codes 355.6 Lesion of plantar nerve 373.2 Chalazion 440.23 Atherosclerosis of native arteries of the extremities with ulceration 440.24 Atherosclerosis of native arteries of the extremities with gangrene 443.9 Peripheral vascular disease, unspecified 715.38 Osteoarthrosis, localized, not specified whether primary or secondary, other specified sites 726.79 Other enthesopathy of ankle and tarsus 726.91 Exostosis of unspecified site 735.0 Hallux valgus (acquired) 735.2 Hallux rigidus 785.4 Gangrene Covered ICD-10 CM - Diagnosis Code G57.60-G57.62 Lesion of plantar nerve H00.11-H00.19 Chalazion I70.231-I70.25 Atherosclerosis of native arteries with ulceration I70.261-I70.269 Atherosclerosis of native arteries of extremities with gangrene Atherosclerosis of unspecified type of bypass graft(s) of the extremities with I70.361-I70.369 gangrene I70.461-I70.469 Atherosclerosis of autologous vein bypass graft(s) of the extremities with Clinical Coverage Guideline page 6
gangrene Atherosclerosis of nonautologous biological bypass graft(s) of the extremities I70.561-I70.569 with gangrene Atherosclerosis of nonbiological bypass graft(s) of the extremities with I70.661-I70.669 gangrene Atherosclerosis of other type of bypass graft(s) of the extremities with I70.761-I70.769 gangrene I73.9 Peripheral vascular disease, unspecified I96 Gangrene, not elsewhere classified M19.90 Unspecified osteoarthritis, unspecified site M20.10-M20.12 Hallux valgus (acquired) M25.70 Osteophyte, unspecified joint M76.70-M76.72 Peroneal tendinitis, unspecified leg M77.50-M77.52 Other enthesopathy *Current Procedural Terminology (CPT ) 2015 American Medical Association: Chicago, IL. REFERENCES 1. Laughlin, RT. Bunion. http://emedicine.medscape.com/. Published on March 25, 2014. Accessed September 16, 2015. 2. Canale ST, ed. Campbell's Operative Orthopaedics. 9th ed. St Louis, MO: Mosby Inc.; 1998: 1621-1694. MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS Date Action 10/1/2015 Approved by MPC. New. Clinical Coverage Guideline page 7