Latest Review Date: June 2024

Category: Surgery                                       

POLICY:

Open internal fixation of rib fractures involving 4 or more ribs may be considered medically necessary for the treatment of flail chest or multiple, severely displaced non-flail pattern fractures in individuals with respiratory failure due to refractory pain or severe chest wall deformity and absence of severe traumatic brain injury.

Open internal rib fixation is considered investigational for all other indications.

Percutaneous or thoracoscopic stabilization of rib fractures is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Rib fractures are the common chest injury sustained from a variety of primarily blunt injury mechanisms. Although most injuries to the chest wall do not result in long-term respiratory dysfunction requiring operative management, multiple fractured ribs or flail chest can significantly compromise respiratory function. Pain with inspiration and expiration, along with inability to properly inflate and deflate the lungs, may require mechanical ventilation to assist with respiratory effort. Flail chest is diagnosed when multiple, consecutive ribs are fractured in two or more places, creating an incompetent region of the chest wall. The paradoxical movement associated with flail chest increases the work of breathing, compromises respiratory function, and may necessitate intubation and ventilatory upport. Simple rib fractures can be treated with analgesia and respiratory care to prevent complications such as pneumonia or atelectasis. Complex rib fractures or multiple rib fractures may require a more aggressive treatment plan.

Although the majority of patients will heal their rib fractures with conservative measures, surgical management may be beneficial for selected patients. Surgical management may be effective for reducing pain, improving pulmonary function, and facilitating bony healing by reducing movement and providing close apposition of the ends of the ribs. Recent studies have explored the option of internal fixation of rib fracture for treatment of complex rib fractures, including flail chest, open fracture, symptomatic nonunion, and thoracotomy for other indications.

The following are generally accepted as criteria for operative rib fixation:

• Impending or actual respiratory failure due to painful, movable ribs refractory to pain management strategies (ie, not due to pulmonary contusion). This includes patients with flail chest, or multiple, severely displaced non-flail pattern fractures.
• Significant chest wall deformity.
• Failure to wean from mechanical ventilation (not related to pulmonary contusion).
• Significantly displaced ribs found at thoracotomy being performed for other reasons (eg, open pneumothorax, pulmonary laceration, retained hemothorax, diaphragm hernia, vascular injury).
• Ongoing chest wall instability/deformity or pain due to nonunion or malunion of rib fractures.

The purpose of stabilization is to facilitate ventilator weaning. Thus, if the patient has a significant underlying pulmonary contusion that will prevent weaning within a reasonable period of time, there would be little benefit to a procedure. Similarly, surgical stabilization of fractured ribs is contraindicated in patients with concomitant head injury that precludes separation from mechanical ventilation. There is no role for surgical stabilization for patients with severe pulmonary contusion as the cause for respiratory insufficiency.

Internal fixation is indicated to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs. The standard approach to operative fixation of the ribs uses titanium plates placed from the outside of the chest wall and secured into place using locking screws. Absorbable plates were used for rib fracture fixation in the past; however, the incidence of non- or partial healing was between 11 and 56 percent, and this type of plate is no longer used.  There are different plating systems currently available in the United States, but there are no comparative studies upon which to base a recommendation to use one system over the other. Some plating systems are based on bicortical fixation of the plate (e.g., MatrixRIB, RibFix Blu, Advantage Rib), while another (RibLoc) uses a U-plate design that provides fixation to both sides of the cortex as well as to both the anterior and posterior aspects of the titanium plate.  Another system (Level One) is based upon fixation to the anterior cortex only using screws that are placed at an angle.

KEY POINTS:

The most recent literature update was performed through June 2023.

Summary of Evidence

For internal fixation of complex rib fractures for the treatment of flail chest or multiple, severely displaced non-flail pattern fractures in individuals with impending or actual respiratory failure, the current evidence includes retrospective studies and small sample sizes. Benefits of surgical management of rib fractures are decreased hospital days, decreased intensive care unit days, and decreased days of mechanical ventilation. Although, additional randomized controlled trials with larger populations are still necessary to allow generalization of findings and continued assessment of safety and efficacy of surgical management of rib fractures, the current evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For percutaneous or thorascopic stabilization of rib fractures, the evidence is insufficient to determine the effects of the technology on health outcomes and further studies are needed.

Practice Guidelines and Position Statements

Chest  Wall Injury Society

An international colloquium of trauma, orthopedic and thoracic surgeons (2016) identified the following recommendations for the surgical management of rib fractures:

• Anticipated chronic pain or impaired pulmonary mechanics associated with multiple (at least three), severe (bi-cortical) displaced fractures.
• Acute respiratory failure attributable to fractures (irrespective of radiographic fracture pattern) and refractory to medical management.
• Chronic non-unions for persistent, disabling pain refractory to medical management.
• In select cases, repair of ribs 1, 2, 11, and 12 for marked displacement, vascular impingement, or localized refractory pain.
• Additional thoracic procedures when thoracotomy is required.

Eastern Association of the Surgery of Trauma

The 2012 guidelines state (grade III recommendation): "Although improvement has not been definitively shown in any outcome parameter after surgical fixation of FC [flail chest], this modality may be considered in cases of severe FC failing to wean from the ventilator or when thoracotomy is required for other reasons. The patient subgroup that would benefit from early 'prophylactic'’ fracture fixation has not been identified."

The guidelines also state: "There is insufficient clinical evidence to recommend any type of proprietary implant for surgical fixation of rib fractures. However, in vitro studies indicate that rib plating or wrapping devices are likely superior to intramedullary wires and these should be used as the preferred fixation device."

National Institute for Health and Clinical Excellence (NICE) 

Per the National Institute for Health and Clinical Excellence 2010 guidelines, 

1.1 Current evidence on insertion of metal rib reinforcements to stabilise a flail chest wall is limited in quantity but consistently shows efficacy. In addition, there are no major safety concerns in the context of patients who have had severe trauma with impaired pulmonary function. Therefore the procedure may be used provided that normal arrangements are in place for clinical governance, consent and audit.

1.2 Patient selection should be carried out by critical care specialists, chest physicians and thoracic surgeons with appropriate training and experience.

Western Trauma Association

Per the Western Trauma Association (WTA) 2016 Algorithm, in addition to the severity of the rib fractures, “the patient should be free of other injuries that would prolong intubation or immobility, such as a severe head injury or pelvic fracture. In these cases, rib fixation is not likely to alter the patient's overall clinical course, as the benefits that have been most clearly shown are related to decreasing ventilator days. Second, the fixation should occur early,

ideally within 48 hours of admission, to maximize the likelihood of avoiding ventilator-associated complications that would independently increase ventilator days.”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Rib fracture, ribs, rib fixation, Modular RibLoc System, flail chest, Synthes MatrixRIB Fixation System, AdvantageRib, intramedullary rib fixation, RibFix Blu, Level One (L1) Rib System

APPROVED BY GOVERNING BODIES:

The U.S. Food and Drug Administration (2018) issued 510(k) market approval to several bone fixation appliances designed for rib fixation. These devices are classified as class II prosthetic, orthopedic single or multiple component metallic bone fixation appliances and accessories (21CFR888.3030). Predicate devices are indicated for use in patients who are skeletally mature with normal or osteoporotic bone for chest wall fixation. The RibLoc Rib Fracture Plating System (ACUTE Innovations, LLC; Hillsboro, OR) was cleared by the FDA through the 510(k) process in January 2012; it is indicated to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum.  The RibLoc Rib Fracture Plating System consists of plates and screws for fractures, fusions, and osteotomies.

BENEFIT APPLICATION:

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.

CURRENT CODING:

CPT Codes:

REFERENCES:

1. Ali-Osman F, Mangram A, Sucher J, et al. Geriatric (G60) trauma patients with severe rib fractures: Is muscle sparing minimally invasive thoracotomy rib fixation safe and does it improve post-operative pulmonary function? Am J Surg 2018; 216:46.
2. Althausen PL, Shannon S, Watts C, et al. Early surgical stabilization of flail chest with locked plate fixation. J Orthop Trauma 2011; 25:641.
3. Apampa AA, Ali A, Kadir B, Ahmed Z. Safety and effectiveness of surgical fixation versus non-surgical methods for the treatment of flail chest in adult populations: A systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2022;48(2):1025-1034.
4. Beks RB, Peek J, de Jong MB, et al. Fixation of flail chest or multiple rib fractures: current evidence and how to proceed. A systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2019;45(4):631-644.
5. Bhatnagar A, Mayberry J, Nirula R. Rib fracture fixation for flail chest: what is the benefit? J Am Coll Surg 2012; 215:201.
6. Brasel KJ, Moore EE, Albrecht RA, et al. Western Trauma Association Critical Decisions in Trauma: Management of rib fractures. J Trauma Acute Care Surg. 2017;82(1):200-203.
7. Bugaev N, Breeze JL, Alhazmi M, et al. Magnitude of rib fracture displacement predicts opioid requirements. J Trauma Acute Care Surg 2016; 81:699.
8. Cataneo AJ, Cataneo DC, de Oliveira FH, et al. Surgical versus nonsurgical interventions for flail chest. Cochrane Database Syst Rev 2015; :CD009919.
9. Chest Wall Injury Society: Guideline For SSRF Indications, Contraindications And Timing, Jan 2020.

10. https://cwisociety.org/wp-content/uploads/2020/05/CWIS-SSRF-Guideline-01102020.pdf

11. Coughlin TA, Ng JW, Rollins KE, et al. Management of rib fractures in traumatic flail chest: a meta-analysis of randomised controlled trials. Bone Joint J 2016; 98-B:1119.
12. Dehghan N, de Mestral C, McKee MD, et al. Flail chest injuries: a review of outcomes and treatment practices from the National Trauma Data Bank. J Trauma Acute Care Surg 2014; 76:462.
13. Granetzny A, Abd El-Aal M, Emam E, et al. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg 2005; 4:583.
14. He Z, Zhang D, Xiao H, et al. The ideal methods for the management of rib fractures. J Thorac Dis. 2019;11(Suppl 8):S1078-S1089.
15. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
16. Kasotakis G, Hasenboehler EA, Streib EW, et al. Operative fixation of rib fractures after blunt trauma: A practice management guideline from the Eastern Association for the Surgery of Trauma. J Trauma Acute Care Surg 2017; 82:618.
17. Kocher GJ, Sharafi S, Azenha LF, Schmid RA. Chest wall stabilization in ventilator-dependent traumatic flail chest patients: who benefits?. Eur J Cardiothorac Surg. 2017;51(4):696-701.
18. Lafferty, P,  Anavian, J, Will, R, Cole, P. Operative treatment of Chest wall injuries: Indications, technique, and outcomes, JBJS: January 5, 2011 - Volume 93 - Issue 1 - p 97-110.
19. Leinicke JA, Elmore L, Freeman BD, Colditz GA. Operative management of rib fractures in the setting of flail chest: a systematic review and meta-analysis. Ann Surg 2013; 258:914.
20. Liu T, Liu P, Chen J, et al. A Randomized Controlled Trial of Surgical Rib Fixation in Polytrauma Patients With Flail Chest. J Surg Res 2019; 242:223.
21. Majercik S, Cannon Q, Granger SR, et al. Long-term patient outcomes after surgical stabilization of rib fractures. Am J Surg 2014; 208:88.
22. Majercik S, Vijayakumar S, Olsen G, et al. Surgical stabilization of severe rib fractures decreases incidence of retained hemothorax and empyema. Am J Surg 2015; 210:1112.
23. Marasco SF, Davies AR, Cooper J, et al. Prospective randomized controlled trial of operative rib fixation in traumatic flail chest. J Am Coll Surg 2013; 216:924.
24. National Institute for Health and Clinical Excellence (NICE). Insertion of metal rib reinforcements to stabilise a flail chest wall. Interventional procedures guidance [IPG361]. 2010; https://www.nice.org.uk/guidance/ipg361/chapter/1-Guidance.
25. Oyamatsu H, Ohata N, Narita K. New technique for fixing rib fracture with bioabsorbable plate. Asian Cardiovasc Thorac Ann. 2016;24(7):736-738.
26. Pieracci FM, Coleman J, Ali-Osman F, et al. A multicenter evaluation of the optimal timing of surgical stabilization of rib fractures. J Trauma Acute Care Surg 2018; 84:1.
27. Pieracci FM, Johnson J, Stoval RT, Jurkovich GJ. Completely thoracoscopic, intra-pleural reduction and fixation of severe rib fractures. Trauma Case Rep 2015 (in press).
28. Pieracci FM, Leasia K, Bauman Z, et al. A multicenter, prospective, controlled clinical trial of surgical stabilization of rib fractures in patients with severe, nonflail fracture patterns (Chest Wall Injury Society NONFLAIL). J Trauma Acute Care Surg 2020; 88:249.
29. Pieracci FM, Lin Y, Rodil M, et al. A prospective, controlled clinical evaluation of surgical stabilization of severe rib fractures. J Trauma Acute Care Surg 2016; 80:187.
30. Pieracci FM, Majercik S, Ali-Osman F, et al. Consensus statement: Surgical stabilization of rib fractures rib fracture colloquium clinical practice guidelines. Injury 2017; 48:307.
31. Pieracci FM, Rodil M, Stovall RT, et al. Surgical stabilization of severe rib fractures. J Trauma Acute Care Surg 2015; 78:883.
32. Pieracci FM, Schubl S, Gasparri M, Delaplain P, Kirsch J, Towe C, White TW, Whitbeck S, Doben AR. The Chest Wall Injury Society Recommendations for Reporting Studies of Surgical Stabilization of Rib Fractures. Injury. 2021 Jun;52(6):1241-1250. 
33. Prins JTH, Wijffels MME, Pieracci FM. What is the optimal timing to perform surgical stabilization of rib fractures? J Thorac Dis. 2021 Aug;13(Suppl 1):S13-S25. doi: 10.21037/jtd-21-649. 
34. Sarani B, Allen R, Pieracci FM, et al. Characteristics of hardware failure in patients undergoing surgical stabilization of rib fractures: A Chest Wall Injury Society multicenter study. J Trauma Acute Care Surg 2019; 87:1277.
35. Sawyer E, Wullschleger M, Muller N, Muller M. Surgical rib fixation of multiple rib fractures and flail chest: A systematic review and meta-analysis. J Surg Res. 2022;276:221-234.
36. Simon B, Ebert J, Bokhari F, et al. Management of pulmonary contusion and flail chest: an Eastern Association for the Surgery of Trauma practice management guideline. J Trauma Acute Care Surg 2012; 73:S351.
37. Slobogean GP, MacPherson CA, Sun T, et al. Surgical fixation vs nonoperative management of flail chest: a meta-analysis. J Am Coll Surg 2013; 216:302.
38. Tanaka H, Yukioka T, Yamaguti Y, et al. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma 2002; 52:727.
39. Tignanelli CJ, Rix A, Napolitano LM, et al. Association Between Adherence to Evidence-Based Practices for Treatment of Patients With Traumatic Rib Fractures and Mortality Rates Among US Trauma Centers. JAMA Netw Open 2020; 3:e201316.
40. U.S. Food and Drug Administration 510(k) Premarket Notification Database. ACUTE Innovations, LLC Modular RibLOC Fixation System. No. 113318. Rockville, MD: FDA. January 12, 2012. https://www.accessdata.fda.gov/cdrh_docs/pdf11/K113318.pdf.
41. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Sig Medical Corporation AdvantageRib System. No. K183317. Rockville, MD: FDA. February 14, 2019. https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183317.pdf.
42. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Synthes MatrixRIB Fixation System. No. K081623. Rockville, MD: FDA. September 8, 2008. http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081623.pdf.

POLICY HISTORY:

Medical Policy Group, July 2020 (7): New policy addressing internal fixation of rib fractures.

Medical Policy Group, August 2021 (7): Reviewed by consensus. Literature review completed; no new literature to add. Removed “not medically necessary” statement from Policy Statement. No change in intent.

Medical Policy Group, July 2022 (7): Reviewed by consensus. Literature review completed, references added. No change in Policy Statement.

Medical Policy Group, June 2023 (7): Reviewed by consensus. Literature review completed, references added. Update to Benefit Application. No change in Policy Statement.

Medical Policy Group, July 2024 (7): Reviewed by consensus. Literature review completed, references added. 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.