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Medical Policy Ultrasound Accelerated Fracture Healing Device Medical Policy Ultrasound Accelerated Fracture Healing Device Table of Contents Policy: Commercial Coding Information Information Pertaining to All Policies Policy: Medicare Description References Authorization Information Policy History Policy Number: 497 BCBSA Reference Number: 1.01.05 Related Policies Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures, #498 Electrical Bone Growth Stimulation of the Appendicular Skeleton, #499 Bone Morphogenetic Protein, #097 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Members Low-intensity ultrasound treatment may be MEDICALLY NECESSARY when used as an adjunct to conventional management (i.e., closed reduction and cast immobilization) for the treatment of fresh, closed fractures in skeletally mature individuals. Candidates for ultrasound treatment are those at high risk for delayed fracture healing or nonunion. These risk factors may include either locations of fractures or patient comorbidities and include the following: Patient comorbidities: Diabetes, Steroid therapy, Osteoporosis, History of alcoholism, History of smoking. Fracture locations: Jones fracture, Fracture of navicular bone in the wrist (also called the scaphoid), Fracture of metatarsal, Fractures associated with extensive soft tissue or vascular damage. Low-intensity ultrasound treatment may be MEDICALLY NECESSARY as a treatment of delayed union of bones, including delayed union** of previously surgically-treated fractures, and excluding the skull and vertebra. 1 Low-intensity ultrasound treatment may be MEDICALLY NECESSARY as a treatment of fracture nonunions of bones, including nonunion*** of previously surgically-treated fractures, and excluding the skull and vertebra. Other applications of low-intensity ultrasound treatment are INVESTIGATIONAL, including, but not limited to, treatment of congenital pseudarthroses, open fractures, fresh* surgically-treated closed fractures, stress fractures, arthrodesis or failed arthrodesis. *Fresh (Acute) Fracture A fracture is most commonly defined as “fresh” for 7 days after the fracture occurs. Most fresh closed fractures heal without complications with the use of standard fracture care, ie, closed reduction and cast immobilization. **Delayed Union Delayed union is defined as a decelerating healing process as determined by serial radiographs, together with a lack of clinical and radiologic evidence of union, bony continuity, or bone reaction at the fracture site for no less than 3 months from the index injury or the most recent intervention. ***Nonunion There is not a consensus for the definition of nonunions. One proposed definition is failure of progression of fracture-healing for at least 3 consecutive months (and at least 6 months following the fracture) accompanied by clinical symptoms of delayed/nonunion (pain, difficulty weight bearing).(1) The definition of nonunion in FDA labeling suggests that nonunion is considered established when the fracture site shows no visibly progressive signs of healing, without giving any guidance regarding the timeframe of observation. However, it is suggested that a reasonable time period for lack of visible signs of healing is 3 months. The following patient selection criteria are consistent with those proposed for electrical stimulation as a treatment of nonunions: At least 3 months have passed since the date of the fracture, AND serial radiographs have confirmed that no progressive signs of healing have occurred, AND the fracture gap is 1 cm or less, AND the patient can be adequately immobilized and is of an age when he/she is likely to comply with nonweight bearing. Medicare HMO BlueSM and Medicare PPO BlueSM Members BCBSMA covers an ultrasonic osetogenesis stimulator device for the following indications for Medicare HMO Blue and Medicare PPO Blue members in accordance with CMS LCD: Nonunion of a fracture documented by a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenic stimulator, separated by a minimum of 90 days. Each radiograph set must include multiple views of the fracture site accompanied by a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs; and The fracture is not of the skull or vertebrae; and The fracture is not tumor related Local Coverage Determination (LCD) for Osteogenesis Stimulators (L11501) http://www.cms.gov/medicare-coverage-database/details/lcd- details.aspx?LCDId=11501&ContrId=137&ver=33&ContrVer=1&CoverageSelection=Both&ArticleType=Al l&PolicyType=Final&s=Massachusetts&CptHcpcsCode=e0760&bc=gAAAABAAAAAAAA%3d%3d& Prior Authorization Information See below for situations where prior authorization may be required or may not be required. Yes indicates that prior authorization is required. No indicates that prior authorization is not required. Outpatient Inpatient 2 Commercial Managed Care (HMO and POS) No n/a Commercial PPO and Indemnity No n/a Medicare HMO BlueSM No n/a Medicare PPO BlueSM No n/a CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. A draft of future ICD-10 Coding related to this document, as it might look today, is included below for your reference. Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. CPT Codes CPT codes: Code Description 20979 Low intensity ultrasound stimulation to aid bone healing, noninvasive (nonoperative) HCPCS Codes HCPCS codes: Code Description E0760 Osteogenesis stimulator, low-intensity ultrasound, non-invasive ICD-9 Diagnosis coding ICD-9-CM diagnosis codes: Code Description 733.82 Nonunion of fracture 807.00 Closed fracture of rib(s), unspecified 807.01 Closed fracture of one rib 807.02 Closed fracture of two ribs 807.03 Closed fracture of three ribs 807.04 Closed fracture of four ribs 807.05 Closed fracture of five ribs 807.06 Closed fracture of six ribs 807.07 Closed fracture of seven ribs 807.08 Closed fracture of eight or more ribs 807.09 Closed fracture of multiple ribs, unspecified 807.2 Closed fracture of sternum 807.4 Flail chest 807.5 Closed fracture of larynx and trachea 808.0 Closed fracture of acetabulum 808.2 Closed fracture of pubis 808.41 Closed fracture of ilium 808.42 Closed fracture of ischium 808.43 Multiple closed pelvic fractures with disruption of pelvic circle 3 808.44 Multiple closed pelvic fractures without disruption of pelvic circle 808.49 Closed fracture of other specified part of pelvis 808.8 Closed unspecified fracture of pelvis 809.0 Fracture of bones of trunk, closed 810.00 Closed fracture of clavicle, unspecified part 810.01 Closed fracture of sternal end of clavicle 810.02 Closed fracture of shaft of clavicle 810.03 Closed fracture of acromial end of clavicle 811.00 Closed fracture of scapula, unspecified part 811.01 Closed fracture of acromial process of scapula 811.02 Closed fracture of coracoid process of scapula 811.03 Closed fracture of glenoid cavity and neck of scapula 811.09 Closed fracture of scapula, other 812.00 Closed fracture of unspecified part of upper end of humerus 812.01 Closed fracture of surgical neck of humerus 812.02 Closed fracture of anatomical neck of humerus 812.03 Closed fracture of greater tuberosity of humerus 812.09 Other closed fracture of upper end of humerus 812.20 Closed fracture of unspecified part of humerus 812.21 Closed fracture of shaft of humerus 812.40 Closed fracture of unspecified part of lower end of humerus 812.41 Closed supracondylar fracture of humerus 812.42 Closed fracture of lateral condyle of humerus 812.43 Closed fracture of medial condyle of humerus 812.44 Closed fracture of unspecified condyle(s) of humerus 812.49 Other closed fracture of lower end of humerus 813.00 Closed fracture of upper end of forearm, unspecified 813.01 Closed fracture of olecranon process of ulna 813.02 Closed fracture of coronoid process of ulna 813.03 Closed Monteggia's fracture 813.04 Other and unspecified closed fractures of proximal end of ulna (alone) 813.05 Closed fracture of head of radius 813.06 Closed fracture of neck of radius 813.07 Other and unspecified closed fractures of proximal end of radius (alone) 813.08 Closed fracture of radius with ulna, upper end [any part] 813.20 Closed fracture of shaft of radius or ulna, unspecified 813.21 Closed fracture of shaft of radius (alone) 813.22 Closed fracture of shaft of ulna (alone) 813.23 Closed fracture of shaft of radius with ulna 813.40 Closed fracture of lower end of forearm, unspecified 813.41 Closed Colles' fracture 813.42 Other closed fractures of distal end of radius (alone) 813.43 Closed fracture of distal end of ulna (alone) 813.44 Closed fracture of lower end of radius with ulna 4 813.45 Torus fracture of radius (alone) 813.46 Torus fracture of ulna (alone) 813.47 Torus fracture of radius and ulna 813.80 Closed fracture of unspecified part of forearm 813.81 Closed fracture of unspecified part of radius (alone) 813.82 Closed fracture of unspecified part of ulna (alone) 813.83 Closed fracture of unspecified part of radius with ulna 814.00 Closed fracture of carpal bone, unspecified 814.01 Closed fracture
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