mp-331 - Medical Policies - Florida
Ultrasound Accelerated Fracture Healing Device
Policy Number: MP-331
Latest Review Date: March 2020
Policy Grade: B
Low-intensity ultrasound treatment (E0760) may be considered 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 nonunions. These risk factors may include either locations of fractures or patient morbidities and include any one of the following:
- Patient Comorbidities
- Steroid therapy
- Alcoholism history
- Obesity greater than 50% over ideal weight
- Severe anemia
- End Stage Renal disease
- Fracture locations
- Radial fractures that are closed & posteriorly displaced (Colles fx)
- Tibial diaphysis fractures that are closed or grade I open (wound <1cm with minimal soft tissue injury, wound bed is clean and bone injury is simple with minimal comminution)
- Jones Fracture, 5th metatarsal
- Navicular (scaphoid) fracture
- Fractures associated with extensive soft tissue or vascular damage
- Metatarsal fracture
Low intensity ultrasound treatment (E0760) may be considered medically necessary as a treatment of delayed union of bones, including nonunion of previously surgically-treated fractures, and excluding the skull and vertebra, when the following criteria are met:
- A decelerating healing process is documented by a lack of clinical and radiologic (serial x-rays) evidence of union, bony continuity or bone reaction at the fracture site for no less than 16 weeks from the index injury or the most recent intervention.
Low-intensity ultrasound treatment (E0760) may be considered medically necessary as a treatment of fracture non-unions of bones, including nonunion of previously surgically-treated fractures, and excluding the skull and vertebra, when all of the following criteria are met:
- The treatment is for nonunion of bones other than the skull or vertebrae (e.g., radius, ulna, humerus, clavicle, tibia, femur, fibula, carpal, metacarpal, tarsal and metatarsal).
- The nonunion is not related to, or due to, a malignancy.
- It is ≥ 90 days from the date of initial treatment of the fracture.
- The fracture nonunion is documented by at least 2 sets of appropriate imaging studies, multiple views, separated by a minimum of 90 days confirming that clinically significant healing has not occurred, with written interpretation by a physician stating such.
- A fracture gap of ≤1 cm.
- The patient can be adequately immobilized and is of an age where he/she is likely to comply with non-weight bearing (if fracture is of a weight-bearing bone).
Low-intensity ultrasound treatment (E0760) is considered not medically necessary and investigational when utilized for other applications including but not limited to:
- Congenital pseudarthrosis
- Fractures that are Open Grade II or III
- Fresh surgically-treated closed fractures (with or without internal fixation)
- Fractures too unstable for closed reduction/casting
- Fractures involving immature skeletal system
- Pathological fractures due to bone pathology or malignancy
- Treatment of Charcot foot disorder
- Avascular necrosis of the femoral head
- Fractures, failed fusions, or nonunions of the axial skeleton (skull and vertebrae)
- Chronic epicondylitis
- Prosthesis loosening following hip arthroplasty
- Stress fractures
DESCRIPTION OF PROCEDURE OR SERVICE:
Low-intensity pulsed ultrasound (LIPUS) has been investigated as a technique to accelerate healing of fresh fractures, surgically treated closed fractures, delayed unions, nonunions, stress fractures, osteotomy sites, and distraction osteogenesis. LIPUS is administered using a transducer applied to the skin surface overlying the fracture site.
An estimated 7.9 million fractures occur annually in the United States. Most bone fractures heal spontaneously over the course of several months following standard fracture care (closed reduction if necessary, followed by immobilization with casting or splinting). However, approximately 5% to 10% of all fractures have delayed healing, resulting in continued morbidity and increased utilization of health care services. Factors contributing to a nonunion include which bone is fractured, fracture site, degree of bone loss, time since injury, extent of soft tissue injury, and patient factors (e.g., smoking, diabetes, systemic disease).
There is no standard definition of a fracture nonunion. The Food and Drug Administration has defined nonunion as when “a minimum of 9 months has elapsed since injury and the fracture site shows no visibly progressive signs of healing for a minimum of 3 months." Other definitions cite 3 to 6 months of time from the original injury, or simply when serial radiographs fail to show any further healing. These definitions do not reflect the underlying conditions in fractures that affect healing, such as the degree of soft tissue damage, alignment of the bone fragments, vascularity, and quality of the underlying bone stock.
Delayed union is generally considered a failure to heal between 3 and 9 months post fracture, after which the fracture site would be considered a nonunion. Delayed union may also be defined as a decelerating bone healing process, as identified in serial radiographs. (In contrast, nonunion serial radiographs show no evidence of healing.) It is important to include both radiographic and clinical criteria to determine fracture healing status. Clinical criteria include the lack of ability to bear weight, fracture pain, and tenderness on palpation.
Low-intensity pulsed ultrasound (LIPUS) has been proposed to accelerate healing of fractures. LIPUS is believed to alter the molecular and cellular mechanisms involved in each stage of the healing process (inflammation, soft callus formation, hard callus formation, and bone remodeling). The mechanism of action at the cellular level is not precisely known, but it is theorized that LIPUS may stimulate the production or the activities of the following compounds that contribute to the bone healing process: cyclooxygenase-2, collagenase, integrin proteins, calcium, chondroblasts, mesenchymal cells, fibroblasts, and osteoblasts.
Low intensity pulsed ultrasound treatment is self-administered with 1 daily 20 minute treatment, continuing until the fracture has healed, usually for about 5 months.
The most recent literature update was performed through January 30, 2020.
Summary of Evidence
For individuals who have fresh fractures (surgically or nonsurgically managed) who receive LIPUS as an adjunct to routine care, the evidence includes RCTs and several meta-analyses. Therelevant outcomes are symptoms, morbid events, functional outcomes, and QOL. The evidence base has recently evolved with the publication of a large RCT and meta-analysis significantly shifting the weight of the evidence. Conclusions based on several earlier and small RCTs, rated at high-risk of bias, showed a potential benefit of LIPUS; however, the large RCT published in 2016, rated at low-risk of bias, showed no benefit. A 2017 meta-analysis including only trials with low-risk of bias found no difference in days to full weight bearing, pain reduction, or days to radiographic healing. Similarly, the overall results of the meta-analysis found no significant difference in return to work, subsequent operations, or adverse events.
For individuals who have fracture nonunion or delayed union fracture who receive LIPUS as an adjunct to routine care including surgery, if appropriate, the evidence includes only lower quality studies consisting of a small systematic review in scaphoid nonunions, a meta-analysis of nonunion in various locations, two low-quality RCTs, and one observational comparative study. Therelevant outcomes are symptoms, morbid events, functional outcomes, and QOL. Of thetwo RCTs, onedid not include functional outcomes. The second RCT had a small sample size and did not describe the randomization procedure. The observational study reported similar healing rates with LIPUS and surgery, though the retrospective nature of the study , limits meaningful interpretation of these results. Additionally, the evidence base on the use of LIPUS in the management of fresh fractures has evolved as described above, and there is no demonstrated physiologic mechanism suggesting differential results of LIPUS in fracture nonunion or delayed union.
For individuals who have stress fractures, osteotomy sites, or distraction osteogenesis who receive LIPUS as an adjunct to routine care, the evidence includes only lower quality studies consisting of small RCTsand one meta-analysis for distraction osteogenesis. Therelevant outcomes are symptoms, morbid events, functional outcomes, and QOL. Results do not generally include functional outcomes and results across various outcomes, primarily time to radiographic healing, are inconsistent. The meta-analysis of three trials using LIPUS for distraction osteogenesis reported no statistically significant differences in physiological or functional outcomes. Additionally, the evidence base on the use of LIPUS in the management of fresh fractures has evolved as described above and there is no demonstrated physiologic mechanism suggesting differential results of LIPUS in stress fractures, osteotomy sites, or distraction osteogenesis. The evidence is insufficient to determine the effects of the technology on health outcomes.
PRACTICE GUIDELINES AND POSITION STATEMENTS
British Medical Journal (BMJ) Rapid Recommendation
The BMJ Rapid Recommendations are a series of articles, produced by BMJ in collaboration with the MAGIC group, to provide clinicians with practice guidelines. In 2017, BMJ Rapid Recommendations published guidelines on the use of LIPUS for bone healing. The guidelines were based on a 2017 systematic review, which included 26 randomized controlled trials evaluating patients with fresh fractures not surgically managed, fresh fractures surgically managed, nonunion fractures, osteotomy, and distraction osteogenesis. The committee concluded that there is "moderate to high certainty evidence to support a strong recommendation against the use of LIPUS for bone healing." Furthermore, the guideline expert panel discussed whether the results of higher quality studies in patients with fresh fractures reported in Schandelmaier et al (2017) would apply to other types of fractures including nonunions and osteotomies. "After extensive deliberations, the panel found no compelling anatomical or physiological reasons why LIPUS would probably be beneficial in these other patient populations."
National Institute for Health and Clinical Excellence
In 2018, the NICE published a guidance on the use of LIPUS to promote healing of fresh fractures at low-risk of non-healing. The guidance states that the "current evidence does not show efficacy. Therefore, this procedure should not be used for this indication."
In 2018, the NICE published a guidance on the use of LIPUS to promote healing of fresh fractures at high-risk of non-healing. The guidance states that the "current evidence on efficacy is very limited in quantity and quality. Therefore, this procedure should only be used in the context of research.
In 2018, the NICE published a guidance on the use of LIPUS to promote healing of delayed and nonunion fractures. The guidance states that the "current evidence on efficacy is inadequate in quality. Therefore, this procedure should only be used with special arrangements for clinical governances, consent and audit or research."
In 2013, the NICE published guidance on Exogen for the treatment of long-bone fractures with nonunion and delayed fracture healing.The NICE concluded that use of the Exogen bone healing system to treat long-bone fractures with nonunion is supported by "clinical evidence" and "cost savings … through avoiding surgery." For long-bone fractures with delayed healing, defined as no radiologic evidence of healing after three months, there was "some radiologic evidence of improved healing." However, due to "substantial uncertainties about the rate at which bone healing progresses without adjunctive treatment between 3 and 9 months after fracture" and need for surgery, "cost consequences" were uncertain. . In 2019, the Exogen guidance was updated with a review of studies published after June 2012. The review decision stated, "Overall the additional clinical evidence identified since the guidance was published in 2013 supports the current recommendations." The reviewers did not consider the Schandelmaier et al (2017) systematic review because it pooled fresh fractures and distraction osteogenesis alongside non-unions.
American Academy of Orthopaedic Surgeons
In 2009, the American Academy of Orthopaedic Surgeons (AAOS) has published guidelines on the treatment of distal radius fractures. The AAOS issued a limited recommendation for use of ultrasound for adjuvant treatment of distal radius fractures. While evidence from one study demonstrated an increased rate in healing (measured by absence of pain and radiographic union), the additional cost of LIPUS, resulted in a “limited” recommendation.
U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS
Fracture, nonunion, delayed union, bone growth stimulator, ultrasound accelerated fracture healing device, low intensity ultrasound stimulator, osteogenesis stimulator, percutaneous, pseudarthrosis, pseudoarthrosis, Exogen 2000™, Exogen 3000, SAFHS® Model 2A, SAFHS® Model 2000, Exogen 4000
APPROVED BY GOVERNING BODIES:
In 1994, the Sonic Accelerated Fracture Healing System (SAFHS®; later renamed Exogen 2000® and since 2006, Exogen 4000+; Bioventus) was approved by the FDA through the premarket approval process for treatment of fresh, closed, posteriorly displaced distal radius (Colles) fractures, and fresh, closed, or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. In February 2000, the labeled indication was expanded to include the treatment of established nonunions, excluding skull and vertebra.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply.
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Low intensity ultrasound stimulation to aid bone healing, non-invasive (nonoperative)
Osteogenesis stimulator, low intensity ultrasound; non-invasive
American Academy of Orthopaedic Surgeons. The treatment of distal radius fractures. 2009. Available online at: www.aaos.org/research/guidelines/drfguideline.pdf. Accessed February 27, 2019.
Bhandari M, Fong K, Sprague S et al. Variability in the definition and perceived causes of delayed unions and nonunions: a cross-sectional, multinational survey of orthopaedic surgeons. J Bone Joint Surg Am 2012; 94(15):e1091-6.
- Biglari B, Yildirim TM, Swing T, Bruckner T, Danner W, Moghaddam A. Failed treatment of long bone non-unions with low intensity pulsed ultrasound. Arch Orthop Trauma Surg. Aug 2016; 136(8):1121-1134.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Ultrasound accelerated fracture healing. TEC Assessments 1995; Volume 10, Tab 14.
- Busse JW, Bhandari M, Einhorn TA, et al. Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial. BMJ. Oct 25 2016; 355:i5351.
- Busse JW, Bhandari M, Einhorn TA, et al. Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study. Trials. 2014; 15:206.
- Busse JW, Bhandari M, Kulkarni AV, et al. The effect of low-intensity pulsed ultrasound therapy on time to fracture healing: a meta-analysis. CMAJ 2002; 166(4):437-41.
- Busse JW, et al. Low intensity pulsed ultrasonography for fractures: Systematic review of randomized controlled trials. BMJ 2009; 338:b351.
- Buza JA, 3rd, Einhorn T. Bone healing in 2016. Clin Cases Miner Bone Metab. May-Aug 2016;13(2):101-105.
- Centers for Medicare & Medicaid Services. National Coverage Decision for Osteogenic Stimulators (150.2). 2005; https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?NCDId=65&ncdver=2&DocID=150.2&bc=gAAAABAAAAAA&. Accessed January 31, 2020.
- Dijkman BG, Busse JW, Walter SD et al. The impact of clinical data on the evaluation of tibial fracture healing. Trials 2011; 12:237.
- Dudda M, Hauser J, Muhr G et al. Low-intensity pulsed ultrasound as a useful adjuvant during distraction osteogenesis: a prospective, randomized controlled trial. J Trauma 2011; 71(5):1376-80.
- El-Mowafi H, Mohsen M. The effect of low-intensity pulsed ultrasound on callus maturation in tibial distraction osteogenesis. Int Orthop. Apr 2005;29(2):121-124.
- Emami A, Petren-Mallmin M and Larsson S. No effect of low-intensity ultrasound on healing time of intramedullary fixed tibial fractures. J Orthop Trauma 1999; 13(4):252-7.
- Griffin XL, Parsons N, Costa ML, et al. Ultrasound and shockwave therapy for acute fractures in adults. Cochrane Database Syst Rev. 2014; 6:CD008579.
- Griffin XL, Smith N, Parsons N et al. Ultrasound and shockwave therapy for acute fractures in adults. Cochrane Database Syst Rev 2012; 2:CD008579.
- Heckman JD, Ryaby JP, et al. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. Am J bone Joint Surg, January 1994; 76(1): 26-34.
- Jingushi S, Mizuno K, Matsushita T, et al. Low-intensity pulsed ultrasound treatment for postoperative delayed union or non-union of long bone fractures. J Orthop Sci 2007; 12(1):35-41.
- Kristiansen TK, Ryaby JP, et al. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. Am J Bone Joint Surg, July 1997; 79(7): 961-973.
- Leighton R, Watson JT, Giannoudis P, et al. Healing of fracture nonunions treated with low-intensity pulsed ultrasound (LIPUS): A systematic review and meta-analysis. Injury. Jul 2017;48(7):1339-1347.
- Leung KS, Lee WS, Tsui HF, et al. Complex tibial fracture outcomes following treatment with low-intensity pulsed ultrasound. Ultrasound Med Biol 2004; 30(3):389-95.
- Lou S, Lv H, Li Z, et al. The effects of low-intensity pulsed ultrasound on fresh fracture: A meta-analysis. Medicine (Baltimore). Sep 2017;96(39):e8181.
- Lubbert PH, van der Rijt RH, et al. Low-intensity pulsed ultrasound (LIPUS) in fresh clavicle fractures: A multi-centre double blind randomized controlled trial. Injury, December 2008; 39(12): 1444-1452.
- MAGIC: Making GRADE the Irrestible Choice. n.d.; www.magicproject.org. Accessed February 1, 2018.
- Mayr E, Rudzki MM, Rudzki M, et al. [Does low intensity, pulsed ultrasound speed healing of scaphoid fractures?]. Handchir Mikrochir Plast Chir. Mar 2000; 32(2):115-122.
- National Institute for Health and Care Excellence (NICE). EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing [MTG12]. 2013 (Updated 2019); https://www.nice.org.uk/guidance/mtg12. Accessed January 31, 2020
- National Institute for Health and Care Excellence (NICE). Low-intensity pulsed ultrasound to promote healing of fresh fractures at low risk of non-healing [IPG621]. 2018; https://www.nice.org.uk/guidance/ipg621. Accessed February 27, 2019.
- National Institute for Health and Care Excellence (NICE). Low-intensity pulsed ultrasound to promote healing of fresh fractures at high risk of non-healing [IPG622]. 2018; https://www.nice.org.uk/guidance/ipg622. Accessed February 27, 2019.
- National Institute for Health and Care Excellence (NICE). Low-intensity pulsed ultrasound to promote healing of delayed-union and non-union fractures [IPG623]. 2018; https://www.nice.org.uk/guidance/ipg623. Accessed February 27, 2019.
- National Institute for Health and Care Excellence (NICE). Low-intensity pulsed ultrasound to promote healing of delayed-union and non-union fractures [IPG623]. 2018; https://www.nice.org.uk/guidance/ipg623. Accessed January 31, 2020.
- National Institute for Health and Care Excellence. Low-intensity pulsed ultrasound to promote fracture healing. IPG 374. 2010; https://www.nice.org.uk/guidance/ipg374/chapter/1-Guidance. Accessed February 1, 2018.
- National Institute for Health and Care Excellence. NICE medical technology guidance 12: EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing. 2013. Available online at: www.nice.org.uk/nicemedia/live/14018/62289/62289.pdf. Accessed February 1, 2018.
- Nolte P, Anderson R, Strauss E, et al. Heal rate of metatarsal fractures: A propensity-matching study of patients treated with low-intensity pulsed ultrasound (LIPUS) vs. surgical and other treatments. Injury. Nov 2016; 47(11):2584-2590.
- Poolman RW, Agoritsas T, Siemieniuk RA, et al. Low intensity pulsed ultrasound (LIPUS) for bone healing: a clinical practice guideline. BMJ. Feb 21 2017; 356:j576.
- Ricardo M. The effect of ultrasound on the healing of muscle-pediculated bone graft in scaphoid non-union. Int Orthop. Apr 2006;30(2):123-127.
- Rue JP, Armstrong III DW, et al. The effect of pulsed ultrasound in the treatment of tibial stress fractures. Orthopedics, November 2004; 27(11): 1192-1195.
- Rutten S, Klein-Nulend J, Guit GL, et al. Low-intensity pulsed ultrasound stimulation of delayed unions of the osteotomized fibula: a prospective randomized double-blind trial. Low-intensity pulsed ultrasound treatment in delayed bone healing [thesis]. Amsterdam, the Netherlands: Vrije Universiteit Amsterdam; 2012.
- Rutten S, Nolte PA, Guit GL, et al. Use of low-intensity pulsed ultrasound for posttraumatic non-unions of the tibia: A review of patients treated in the Netherlands. J Trauma 2007; 62(4):902-8.
- Salem KH, Schmelz A. Low-intensity pulsed ultrasound shortens the treatment time in tibial distraction osteogenesis. Int Orthop. Jul 2014; 38(7):1477-1482.
- Schandelmaier S, Kaushal A, Lytvyn L, et al. Low intensity pulsed ultrasound for bone healing: systematic review of randomized controlled trials. BMJ. Feb 22 2017; 356:j656.
- Schofer MD, Block JE, Aigner J et al. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord 2010; 11:229.
- Schortinghuis J, Bronckers AL, Gravendeel J, et al. The effect of ultrasound on osteogenesis in the vertically distracted edentulous mandible: a double-blind trial. Int J Oral Maxillofac Surg. Nov 2008;37(11):1014-1021.
- Schortinghuis J, Bronckers AL, Stegenga B, et al. Ultrasound to stimulate early bone formation in a distraction gap: a double blind randomised clinical pilot trial in the edentulous mandible. Arch Oral Biol. Apr 2005;50(4):411- 420.
- Seger EW, Jauregui JJ, Horton SA, et al. Low-intensity pulsed ultrasound for nonoperative treatment of scaphoid nonunions: a meta-analysis. Hand (N Y). Apr 01, 2017: 1558944717702470.
- Strauss E, Ryaby JP, McCabe J. Treatment of Jones' fractures of the foot with adjunctive use of low-pulsed ultrasound stimulation [abstract]. J Orthop Trauma. 1999;13(4):310.
- Summary of Safety and Effectiveness Data. Exogen 2000® or Sonic Accelerated Fracture Healing System (SAFHS®). Exogen®, a Smith and Nephew Company, Piscataway, NJ.
- Tarride JE, Hopkins RB, Blackhouse G, et al. Low-intensity pulsed ultrasound for treatment of tibial fractures: an economic evaluation of the TRUST study. Bone Joint J. Nov 2017;99-B(11):1526-1532.
- Tsumaki N, Kakiuchi M, Sasaki J, et al. Low-intensity pulsed ultrasound accelerates maturation of callus in patients treated with opening-wedge high tibial osteotomy by hemicallotasis. J Bone Joint Surg Am. Nov 2004;86-A(11):2399-2405.
- Urita A, Iwasaki N, Kondo M et al. Effect of low-intensity pulsed ultrasound on bone healing at osteotomy sites after forearm bone shortening. J Hand Surg Am 2013; 38(3):498-503.
- Watanabe, YY, Arai, YY, Takenaka, NN, Kobayashi, MM, Matsushita, TT. Three key factors affecting treatment results of low-intensity pulsed ultrasound for delayed unions and nonunions: instability, gap size, and atrophic nonunion.. J Orthop Sci, 2013 Jun 19;18(5).
- Zura R, Della Rocca GJ, Mehta S, et al. Treatment of chronic (>1 year) fracture nonunion: heal rate in a cohort of 767 patients treated with low-intensity pulsed ultrasound (LIPUS). Injury. Oct 2015; 46(10):2036-2041.
- Zura R, Mehta S, Della Rocca GJ, et al. A cohort study of 4,190 patients treated with low-intensity pulsed ultrasound (LIPUS): findings in the elderly versus all patients. BMC Musculoskelet Disord. 2015; 16:45.
Medical Policy Group, October 2008 (4)
Medical Policy Administration Committee, November 2008
Available for comment November 20, 2008-January 5, 2009
Medical Policy Group, February 2009 (4)
Medical Policy Administration Committee, March 2009
Available for comment February 27-April 13, 2009
Medical Policy Group, October 2009 (1)
Medical Policy Administration Committee, October 2009
Available for comment October 20-December 3, 2009
Medical Policy Group, November 2009 (1)
Medical Policy Administration Committee, December 2009
Available for comment December 4, 2009-January 19, 2010
Medical Policy Group, February 2010 (1)
Medical Policy Administration Committee, April 2010
Available for comment April 7-May 21, 2010
Medical Policy Group, February 2010; Regular update (1)
Medical Policy Group, November 2011 (1): Electrical bone stimulator portion removed and put into separate policy #082; Update to Description, Policy, Key Points, and References with criteria for coverage for delayed union
Medical Policy Administration Committee, January 2012
Available for comment January 11 – February 27, 2012
Medical Policy Panel, December 2012
Medical Policy Group, March 2013 (1): Update to policy statement with clarifications, no change to coverage criteria; update to Key Points and References, also.
Medical Policy Panel, January 2014
Medical Policy Group, January 2014 (1): Update to Policy, Key Points and References related to clarification of coverage concerning surgically-treated fractures, fresh versus nonunion; policy statements prior to March 2010 removed
Medical Policy Administration Committee, February 2014
Available for comment February 15 through March 31, 2014
Medical Policy Panel, February 2015
Medical Policy Group, (6): 2015 Update to Key Points and References; no change to policy statement.
Medical Policy Panel, August 2016
Medical Policy Group, August 2016, (6): Updates to Description, Key Points, Summary and References. No change to policy statement.
Medical Policy Panel, March 2017
Medical Policy Group, March 2017 (6): Updates to Key points, Key Words, Governing Bodies, Practice guidelines and References; removed previous policy statement from 2013.
Medical Policy Panel, July 2017
Medical Policy Group, August 2017 (6): Updates to Description, Key Points, and References. No change to policy statement.
Medical Policy Panel March 2018
Medical Policy Group, April 2018 (6): Updates to Key Points, Practice Guidelines and References.
Medical Policy Panel, March 2019
Medical Policy Group, April 2019 (6): Updates to Description, Key Points, Practice Guidelines and References. Title changed to “Ultrasound Accelerated Fracture Healing Device”. No change to policy statement.
Medical Policy Panel, March 2020
Medical Policy Group, March 2020 (6): Updates to Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. No change in Policy Statement.
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.