DESCRIPTION
The reverse shoulder arthroplasty (RSP) is a procedure utilizing a prosthesis that reverses the “ball-and-socket” configuration of the glenohumeral joint. With the reverse shoulder prosthesis, the spherical “ball” component is attached to the glenoid and the cup-shaped polyethylene “socket” is attached to the humerus. Natural shoulder configuration requires a functioning rotator cuff to balance the anterior-superior pull of the deltoid muscle and stabilize the joint. In the absence of stabilization by the rotator cuff, deltoid muscle contraction may result in superior subluxation of the humeral head.
The reverse shoulder arthroplasty (RSP) was specifically designed to address the limitations of conventional prostheses in individuals with a non-functioning irreparable rotator cuff. Bio-mechanically, the RSP moves the center of rotation of the arm laterally and changes the direction of the pull of the deltoid muscle allowing the deltoid to elevate the arm without functioning rotator cuff tendons.
POLICY
Reverse shoulder arthroplasty for the treatment of failed hemiarthroplasty with irreparable rotator cuff deficiency is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below)
Reverse shoulder arthroplasty for the treatment of failed total shoulder arthroplasty with irreparable rotator cuff deficiency is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below)
Reverse shoulder arthroplasty for individuals with a nonfunctioning irreparable rotator cuff with glenohumeral arthropathy is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below)
Reverse shoulder arthroplasty for the treatment of all other conditions is considered investigational.
MEDICAL APPROPRIATENESS
Reverse shoulder arthroplasty is considered medically appropriate if ALL of the following are met:
Used for ANY ONE of the following:
Treatment of failed hemiarthroplasty
Treatment of failed total shoulder arthroplasty with irreparable rotator cuff deficiency
Treatment of a nonfunctioning irreparable rotator cuff with glenohumeral arthropathy
The individual meets ALL of the following:
Is not a candidate for alternative treatments or the alternative treatments have failed
Has adequate deltoid function
Has adequate passive range of motion (e.g. elevation at least 90 degrees is present)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Available evidence from retrospective uncontrolled trials indicates that use of the reverse shoulder arthroplasty (RSP) procedure for individuals with rotator cuff deficiency may result in improved shoulder function in comparison with hemiarthroplasty. The improvement in short-term and intermediate outcomes must be balanced against a higher complication rate and uncertainty regarding long-term outcomes. The available evidence is sufficient for patients to make an informed choice based on assessment of comparative risks and benefits. Reverse shoulder arthroplasty is considered to be an appropriate salvage procedure when no alternative treatment is available that would be expected to result in an acceptable clinical outcome.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2009). Reverse shoulder arthroplasty (7.01.114). Retrieved July 13, 2010 from BlueWeb. (19 articles and/or guidelines reviewed)
Boileau, P., Chuinard, C., Roussanne, Y., Bicknell, R. T., Rochet, N., & Trojani, C. (2008). Reverse shoulder arthroplasty combined with a modified latissimus dorsi and teres major tendon transfer for shoulder pseudoparalysis associated with dropping arm. Clinical Orthopaedics and Related Research, 466 (3), 584-593. (Level 4 Evidence - Independent study)
Canale, S. T. & Beaty, J. H. (Eds.). (2007). Campbell’s Operative Orthopaedics (11th ed., pp 483-524). Philadelphia: Mosby Elsivier.
Cuff, D., Pupello, D., Nazeem, V., Levy, J., & Frankle, M. (2008). Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency. The Journal of Bone and Joint Surgery, 90 (6), 1244-1251. (Level 4 Evidence - Industry sponsored)
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2008, July). Reverse shoulder replacement for irreparable rotator-cuff dysfunction. Retrieved July 13, 2010 from ECRI Institute. (24 articles and/or guidelines reviewed)
Grassi, F. A., Murena, L., Valli, F., & Alberio, R. (2009). Six-year experience with the Delta III reverse shoulder prosthesis. Journal of Orthopaedic Surgery, 17 (2), 151-156.
Martin, T. G., & Iannotti, J. P. (2008). Reverse total shoulder arthroplasty for acute fractures and failed management after proximal humeral fractures. The Orthopedic Clinics of North America, 39 (4), 451-457.
Middernacht, B., De Roo, P. J., Van Maele, G., & De Wilde, L. F. (2008). Consequences of scapular anatomy for reversed total shoulder arthroplasty. Clinical Orthopaedics and Related Research, 466 (6), 1410-1418.
Roy, J. S., Macdermid, J. C., Goel, D., Faber, K. J., Athwal, G. S., & Drosdowech, D. S. (2010). What is a successful outcome following reverse total shoulder arthroplasty? The Open Orthopaedics Journal, 23 (4), 157-163.
U.S. Food and Drug Administration. (2006, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K060704. Retrieved September 16, 2008 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060704.pdf.
U.S. Food and Drug Administration. (2007, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K071379. Retrieved September 16, 2008 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071379.pdf.
U.S. Food and Drug Administration. (2008, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K073676. Retrieved September 16, 2008 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/K073676.pdf.
U.S. Food and Drug Administration. (2008, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K081620. Retrieved September 16, 2008 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081620.pdf.
Wierks, C., Skolasky, R. L., Ji, J. H., McFarland, E. G. (2009). Reverse total shoulder replacement: intraoperative and early postoperative complications. Clinical Orthopaedics and Related Research, 467 (1), 225-234. (Level 3 Evidence - Independent study)
Winifred S. Hayes, Inc. Medical Technology Directory. (2008, May). Reverse shoulder total joint prosthesis. Retrieved July 13, 2010 from www.Hayesinc.com/subscribers (38 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 2/8/2009
MOST RECENT REVIEW DATE: 8/12/2010
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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