Executive Summary: 2016 Interventional Pain and Large Joint Services Guideline Updates

Executive Summary: 2016 Interventional Pain and Large Joint Services Guideline Updates On December 4, 2014, CareCore National and MedSolutions announced a merger that brought together two of the leading medical benefits management (MBM) companies into evicore healthcare. This combination allowed for two complementary businesses to jointly develop a broader portfolio of innovative and efficient solutions that improve quality of care and reduce medical costs. As a result, evicore healthcare is better positioned to enhance our health plan partners ability to control cost growth and improve health outcomes by ensuring their members receive appropriate, evidence-based care. At the outset of the merger, CareCore and MedSolutions each had legacy sets of proprietary and nationally recognized Interventional Pain and Large Joint Services guidelines. evicore has taken advantage of this overlap by merging their respective strengths into one set of harmonized guidelines. The results of that extensive harmonization process resulted in the forthcoming condition based patient/member centric guidelines. The publication of one set of guidelines improves the ability to maintain the highest quality, evidence-based clinical guidelines. The evicore guidelines undergo a formal review annually and are based upon major national and international association and society guidelines and criteria, peer-reviewed literature, major treatises and, input from health plans, practicing academic and community-based physicians. This executive summary represents the results of the most recent annual revision process. Presented in this executive summary are the material changes were made to the evicore Interventional Pain Management and Large Joint Services guidelines. "Material changes" are defined as changes that could greatly impact the approval or denial rat of specific, common requests. (Note: In the following summary, all new language for 2016 is presented in blue font. Language that has been removed for 2016 is crossed through). CMM 200: Epidural Steroid Injections CMM 201: Facet Joint Injections CMM 207: Epidural Adhesiolysis CMM 208: Radiofrequency Ablation CMM 210: Implantable Intrathecal Drug Delivery Systems CMM 311: Knee Arthroplasty The effective date of these changes is targeted for August 19, 2016. 1

CMM 200: Epidural Steroid Injections The definition of Radiculopathy was revised for further clarification. Radiculopathy definition for 2015: Radiculopathy must be documented by physical examination and should be corroborated with imaging studies and/or electrodiagnostic testing if performed. In cases with clearly evident radicular symptoms and correlating neurological findings on examination, imaging studies and/or electrodiagnostic testing is not necessary to clinically document a radiculopathy. The presence of leg pain or arm pain and possible findings on an advanced diagnostic imaging study in and of itself does not substantiate the diagnosis of radiculopathy. There must also be clinical evidence as described above. Radiculopathy definition for 2016: Radiculopathy, for the purpose of this policy, is defined as the presence of severe, disabling pain, dysaethesia(s) or paraesthesia(s) reported by the individual in a specified dermatomal distribution of an involved named spinal root(s) and ONE or MORE of the following: Loss of strength of specific named muscle(s) or myotomal distribution(s) demonstrated on detailed neurologic examination (within the prior 3 months) concordant with nerve root compression of the involved named spinal nerve root(s) Altered sensation to light touch, pressure, pin prick or temperature demonstrated on a detailed neurologic examination (within the prior 3 months) in the sensory distribution concordant with nerve root compression of the involved named spinal nerve root(s) Diminished, absent or asymmetric reflex(es) within the prior 3 months concordant with nerve root compression of the involved named spinal nerve root(s) Either of the following: o A concordant radiologist s interpretation of an advanced diagnostic imaging study (MRI or CT) of the spine demonstrating compression of the involved named spinal nerve root(s) (Performed within the prior 12 months) o Electrodiagnostic studies (EMG/NCV s) diagnostic of nerve root compression of the involved named spinal nerve root(s). (Performed within the prior 12 months). 2

CMM 201: Facet Joint Injections CMM 201: Diagnostic Facet Injections The guidelines were updated to allow for a second diagnostic facet joint injection/medial branch block, as follows: One diagnostic facet joint injection/medial branch block is considered medically necessary to determine whether chronic neck or back pain is of facet joint origin when ALL of the following criteria are met: Pain is exacerbated by extension and rotation, or is associated with lumbar rigidity Pain has persisted despite appropriate conservative treatment (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs, exercise) Clinical findings and imaging studies suggest no other obvious cause of the pain (e.g., spinal stenosis, disc degeneration or herniation, infection, tumor, fracture). When there is greater than 80% pain relief from a single diagnostic facet joint injection/medial branch block, there is sufficient evidence of facet pathology and a second confirmatory block is unnecessary. A second diagnostic facet joint injection/medial branch block is medically necessary when the first diagnostic facet joint injection/medial branch block is positive. A second diagnostic facet joint injection/medial branch block is medically necessary no sooner than one week following the initial diagnostic facet joint injection/medial branch block Positive diagnostic medial branch block or facet joint injection using either a local anesthetic or a local anesthetic combined with corticosteroid as evidenced by either of the following: A beneficial clinical response to an intra-articular facet injection or medial branch block performed with a local anesthetic with greater than 80% pain relief reported for 50% of the duration of the effect of the local anesthetic used A beneficial clinical response to an intra-articular facet joint injection or medial branch block performed with a local anesthetic and a corticosteroid with at least a 50% reduction in pain for at least two (2) weeks. If the first diagnostic facet joint injection/medial branch block is not positive, then a second diagnostic facet joint injection/medial branch block is considered not medically necessary 3

CMM 201: References Added 1. Boswell MV, Manchikanti L, Kaye AD, et al. A best-evidence systematic appraisal of the 2. diagnostic accuracy and utility of facet (zygapophysial) joint injections in chronic spinal pain. Pain Physician 2015;18:E497-E533. 3. Civelek E, Cansever T, Kabatas S, et al. Comparison of effectiveness of facet joint injection and radiofrequency denervation in chronic low back pain. Turk Neurosurg. 2012;22:200-206. 4. Fuchs S, Erbe T, Fischer HL, Tibesku CO. Intraarticular hyaluronic acid versus glucocorticoidinjections for nonradicular pain in the lumbar spine. J Vasc Interv Radiol. 2005; 16:1493-1498. 5. Lakemeier S, LInd M, Schultz W, Fuchs-Winkelmann S, Timmesfeld N, Foelsch C, Peterlein 6. CD. A comparison of intraarticular lumbar facet joint steroid injections and lumbar facet joint radiofrequency denervation in the treatment of low back pain: A randomized, controlled, doubleblind trial. Anesth Analg. 2013;117:228-235 7. Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques of chronic spinal pain: Part II: Guidance and recommendations. Pain Physician. 2013;16:S49-S283. 8. Manchikanti L, Kaye AD, Boswell MV, et al. A systematic review and best evidence synthesis of the effectiveness of therapeutic facet joint interventions in managing chronic spinal pain. Pain Physician. 2015; 18:E535-E582 9. Manchikanti L, Singh V, Falco FJE, Cash KA, Pampati V. Evaluation of lumbar facet joint nerve blocks in managing chronic low back pain: A randomized, double-blind, controlled trial with a 2-year follow-up. Int J Med Sci. 2010;7:124-135. 10. Manchikanti L, Singh V, Falco FJE, Cash KA, Fellows B. Comparative outcomes of a 2-year 11. follow-up of cervical medial branch blocks in management of chronic neck pain: A randomized, double-blind controlled trial. Pain Physician. 2010;13:437-450. 12. Manchikanti L, Pampati V, Bakhit C, et al. Effectiveness of lumbar facet joint nerve blocks in chronic low back pain: A randomized clinical trial. Pain Physician. 2001;4:101-117. 13. Manchikanti L, Singh V, Falco FJE, Cash KA, Pampati V, Fellows B. The role of thoracic medial branch locks in managing chronic mid and upper back pain: A randomized, double-blind, active control trial with a 2-year followup. Anesthesiol Res Pract. 2012;2012:585806. 14. Manchukonda R, Manchikanti K, Cash K, et al. Facet joint pain in chronic spinal pain: an evaluation of prevalence and false-positive rate of diagnostic blocks. J Spinal Disord Tech. 2007;20(7):539-545. 15. Park SC, Kim KH. Effect of adding cervical facet joint injections in a multimodal treatment program for longstanding cervical myofascial pain syndrome with referral pain patterns of cervical facet joint syndrome. J Anesth. 2012;26:738-745 16. Ribeiro LH, Furtado RN, Konai MS, et al. Effect of facet joint injection versus systemic steroids in low back pain: A randomized controlled trial. Spine (Phila Pa 1976). 2013;38:1995-2002. 17. Schneider G, Jull G, Smith A, Emery C, Faris P, Cook C, Frizzell B, Salo P. Derivation of a clinical decision guide in the diagnosis of cervical facet joint pain. Arch Phys Med Rehabil, 2014; 95(9): 1695-701. 18. Yun DH, Kim HS, Yoo SD, Kim DH, Chon JM, Choi SH, Hwang DG, Jung PK. Efficacy of ultrasonographyguided injections in patients with facet syndrome of the low lumbar spine. Ann Rehabil Med. 2012;36:66-71. 4

CMM 207: Epidural Adhesiolysis CMM 207: Epidural Adhesiolysis Indications Previously, Epidural Adhesiolysis was approvable for limited clinical scenarios. evicore now considers this procedure as experimental, investigational or unproven as a treatment for back pain: There is insufficient scientific evidence to support the use of epidural adhesiolysis, performed by catheter or endoscopically, as a treatment for back pain. It is considered experimental, investigational or unproven. CMM 207: Epidural Adhesiolysis References Added 1. Choi E, Nahm FS, Lee PB. Evaluation of prognostic predictors of percutaneous Adhesiolysis using a Racz catheter for post lumbar surgery syndrome or spinal stenosis. Pain Physician. 2013; 16:E531-E536. 2. Gerdesmeyer L, Wagenpfeil S, Birkenmaier C, et al. Percutaneous epidural lysis of adhesions in chronic lumbar radicular pain: A randomized double-blind placebo controlled trial. Pain Physician. 2013; 16:185-196. 3. Helm II S, Benyamin RM, Chopra P, Deer TR, Justiz R. Percutaneous adhesiolysis in the 4. management of chronic low back pain in post lumbar surgery syndrome and spinal stenosis: A systematic review. Pain Physician. 2012; 15:E435-E462. 5. Helm II S, Benyamin RM, Falco FJE. Refinement in evidence synthesis of percutaneousadhesiolysis. Pain Physician. 2013; 16:177-184. 6. Helm II S, Hayek SM, Colson J, et al. Spinal endoscopic adhesiolysis in post lumbar surgerysyndrome: An update of the assessment of the evidence. Pain Physician. 2013; 16:SE125-SE150. 7. Kim SH, Choi WJ, Suh JH, et al. Effects of transforaminal balloon treatment in patients with lumbar foraminal stenosis: A randomized, controlled, double-blind trial. Pain Physician. 2013; 16:213-224. 8. Koh WU, Choi SS, Park WY, et al. Transforaminal hypertonic saline for the treatment of lumbar lateral canal stenosis: A double-blinded, randomized, active-control trial. Pain Physician. 2013; 197-211. 9. Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques of chronic spinal pain: Part II: Guidance and recommendations. Pain Physician. 2013;16:S49-S283. 10. Manchikanti L, Cash KA, McManus CD, Pampati V. Assessment of effectiveness of 11. percutaneous adhesiolysis in managing chronic low back pain secondary to lumbar central spinal canal stenosis. Int J Med Sci. 2013; 10:50-59. 12. Manchikanti L, Manchikanti KN, Gharibo CG, Kaye AD. Efficacy of percutaneous Adhesiolysis in the treatment of lumbar post surgery syndrome. Anesth Pain Med. 2015; in press. 13. Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing lumbar post surgery syndrome: A 2-year follow-up of randomized, controlled trial. J Pain Res. 2012; 5:597-608. 5

CMM 208: Radiofrequency Ablation CMM 208: Conservative Care The duration of conservative care was updated from 4 weeks of conservative care to 3 months. Failure of at least 4 weeks three (3) months of conservative care (e.g., exercise, physical methods including physical therapy, chiropractic care, NSAID s and/or analgesics) To align with the changes made to CMM 201: Facet Joint Injections, CMM 208: Radiofrequency Joint Ablation/Denervation was updated to state that radiofrequency ablation (RFA) of facet mediated pain is considered medically necessary if two sequential diagnostic facet joint injections/medial branch blocks are positive; if the two injections/blocks are not positive, then RFA is considered not medically necessary. Radiofrequency ablation of facet mediated pain is considered medically necessary if two sequential diagnostic facet joint injections/medial branch blocks are positive If the two sequential diagnostic facet joint injections/medial branch blocks are not positive, radiofrequency ablation of facet mediated pain is considered not medically necessary When an injection or block is considered positive, a second (confirmatory) block is not medically necessary to perform a radiofrequency joint denervation/ablation. CMM 208: References Added 1. Boswell MV, Manchikanti L, Kaye AD, et al. A best-evidence systematic appraisal of the 2. diagnostic accuracy and utility of facet (zygapophysial) joint injections in chronic spinal pain. Pain Physician. 2015;18:E497-E533. 3. Civelek E, Cansever T, Kabatas S, et al. Comparison of effectiveness of facet joint injection and radiofrequency denervation in chronic low back pain. Turk Neurosurg. 2012; 22:200-206. 4. Cohen SP, Williams KA, Kurihara C, et al. Multicenter, randomized, comparative costeffectiveness study comparing 0, 1, and 2 diagnostic medial branch (facet joint nerve) block treatment paradigms before lumbar facet radiofrequency denervation. Anesthesiology. 2010; 113:395-405. 5. Dobrogowski J, Wrzosek A, Wordliczek J. Radiofrequency denervation with or without addition of pentoxifylline or methylprednisolone for chronic lumbar zygapophysial joint pain. Pharmacol Rep. 2005;57:475-480. 6. Joo YC, Park JY, Kim KH. Comparison of alcohol ablation with repeated thermal radiofrequency ablation in medial branch neurotomy for the treatment of recurrent thoracolumbar facet joint pain. J Anesth. 2013; 27:390-395. 7. Lakemeier S, Lind M, Schultz W, et al. A comparison of intraarticular lumbar facet joint steroid injections and lumbar facet joint radiofrequency denervation in the treatment of low back pain: A randomized, controlled, double-blind trial. Anesth Analg. 2013;117:228-235. 8. Lord S, Barnsley L, Wallis B, McDonald G, Bogduk N. Percutaneous radio-frequency neurotomy for chronic cervical zygapophyseal-joint pain. N Engl J Med. 1996; 335:1721-1726. 9. MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Med. 2012;13:647-654. 10. Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques of chronic spinal pain: Part II: Guidance and recommendations. Pain Physician. 2013;16:S49-S283. 11. Manchikanti L, Kaye AD, Boswell MV, et al. A systematic review and best evidence synthesis of the effectiveness of therapeutic facet joint interventions in managing chronic spinal pain. Pain Physician. 2015;18:E535-E582. 12. Moon JY, Lee PB, Kim YC, Choi SP, Sim WS. An alternative distal approach for the lumbar 13. medial branch radiofrequency denervation: A prospective randomized comparative study. Anesth Analg. 2013;116:1133-1140. 14. Sapir DA, Gorup JM. Radiofrequency medial branch neurotomy in litigant and non-litigant 15. patients with cervical whiplash. Spine (Phila Pa 1976). 2001;26:E268-E273. 16. Speldewinde GC. Outcomes of percutaneous zygapophysial and sacroiliac joint neurotomy in a community setting. Pain Med. 2011;12:209-218. 6

CMM 210: Implantable Intrathecal Drug Delivery Systems CMM 210: Life Expectancy Criterion Previously, the criteria for trial with percutaneous intrathecal or epidural drug delivery system included the requirement that the patient have a life expectancy of greater than three (3) months. This criterion was removed from the 2016 guidelines for Implantable Intrathecal Drug Delivery Systems. CMM 210: Additional Indications Two additional indications were added to the guidelines for 2016, as follows: A trial with a percutaneous intrathecal drug delivery system for severe, refractory spasticity or chronic intractable dystonia is considered medically necessary when there is failure, contraindication or intolerance to at least a six-week trial of oral antispasmodic drugs and physical therapy. A trial with a percutaneous intrathecal or epidural drug delivery system for cancerrelated pain is considered medically necessary when there is failure, intolerance, or contraindication to noninvasive methods of pain control, including systemic opioids. 7

CMM 311: Knee Arthroplasty CMM 311: CPT Codes The following CPT codes were added to the Knee Arthoplasty guidelines: 27488 Removal of prosthesis, including total knee prosthesis, methylmethacrylate with or without insertion of spacer, knee 27580 Arthrodesis, knee, any technique CMM 311: Age and BMI Previously, patients had to be at least 50 years of age and have a Body Mass Index (BMI) of less than 40 to be considered for a partial knee arthroplasty. Age and BMI requirements were removed from these guidelines for 2016. CMM 311: Not Medically Necessary Criteria Three indications were added to the not medically necessary criteria for Partial (unicompartmental) knee arthroplasty, as follows: Partial (unicompartmental) knee arthroplasty is considered not medically necessary when any of the following criteria is present: Severe Grade III or IV patellofemoral joint arthritis (when unicompartmental arthroplasty to be performed is medial or lateral) Prior high tibial osteotomy Tibial or femoral shaft deformity Radiographic evidence of medial or lateral subluxation Flexion contracture greater than 15º Varus deformity greater than 15º or a valgus deformity greater than 20º Inflammatory arthropathy Active local or systemic infection Severe loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb, rendering the procedure unjustifiable Osteoporosis or other osseous abnormalities which would make the likelihood of a poor outcome more probable Severe lack of collateral ligament integrity leading to joint instability. CMM 311: Simultaneous Bilateral Total Knee Replacement The following language was removed from the knee arthroplasty guidelines: Based on the increased risk of serious complications (cardiac complications, pulmonary complications and mortality) simultaneous bilateral total knee replacement may be considered not medically necessary. 8

CMM 311: References Added/Updated 1. American Academy of Orthopaedic Surgeons (AAOS). AAOS clinical guideline on osteoarthritis of the knee, 2nd edition 2013. Available at: http://www.aaos.org/research/guidelines/treatmentofosteoarthritisofthekneeguideline.pd 2. Berend KR, Lombardi AV Jr, Adams JB. Obesity, young age, patellofemoral disease, and anterior knee pain: identifying the unicondylar arthroplasty patient in the United States. Orthopedics, 2007; 30(5, suppl); 19-23. 3. Meneghini M. Revision Total Knee Arthroplasty. In Glassman AH, Lachiewicz PF, Tanzer M. eds. Orthopaedic Knowledge Update: Hip and Knee Reconstruction 4 th edition, 2011, American Academy of Orthopaedic Surgeons, Rosemont, IL. 4. Newman MT, Lonner JH, Ries M. Unicompartmental, patellofemoral, and bicompartmental arthroplasty. In Glassman AH, Lachiewicz PF, Tanzer M. eds. Orthopaedic Knowledge Update: Hip and Knee Reconstruction 4 th edition, 2011, American Academy of Orthopaedic Surgeons, Rosemont, IL. 5. Skou ST, Roos EM, Laursen MB, Rathleff MS et al. A randomized, controlled trial of total knee replacement.new England Journal of Medicine, 2015; 373(17): 1597-1606. 9

CMM 312: Knee Surgery (Arthroscopic and Open) CPT Codes The following CPT Codes were added to CMM 312: 29881 Arthroscopy, knee, surgical; with meniscectomy (medial OR lateral, including any meniscal shaving) including debridement/shaving of articular cartilage (chondroplasty), same or separate compartment(s), when f d 29882 Arthroscopy, knee, surgical; with meniscus repair (medial OR lateral). 29883 Arthroscopy, knee, surgical; with meniscus repair (medial AND lateral). 29885 Arthroscopy, knee, surgical; drilling for osteochondritis dissecans with bone grafting, with or without internal fixation (including debridement of base of l i ) 29886 Arthroscopy, knee, surgical; drilling for intact osteochondritis dissecans lesion 29887 Arthroscopy, knee, surgical; drilling for intact osteochondritis dissecans lesion with internal fixation 29888 Arthroscopically aided anterior cruciate ligament repair/augmentation or 29889 t ti Arthroscopically aided posterior cruciate ligament repair/augmentation or reconstruction. CMM 312: Anterior Cruciate Ligament Reconstruction Guidelines were added for Anterior Cruciate Ligament Reconstruction: Allograft Knee Ligament Reconstruction - Knee ligament reconstruction (i.e., anterior cruciate) using allograft tissue is considered medically necessary for the treatment of ligament injury (e.g., rupture, laxity) when ANY of the following conditions is met: Previous reconstruction has failed and requires revision Surgical reconstruction requires the use of multiple ligament transfers Individual has a medical condition (e.g., anatomic anomaly, prior knee injury or prior knee surgery) that precludes the use of autograft tissue. Knee ligament reconstruction (i.e., anterior cruciate) using allograft tissue for ANY other indication not listed above is considered not medically necessary. Anterior cruciate ligament reconstruction with allograft (see above for allograft specific criteria) or autograft is considered medically necessary when ALL the following criteria have been met: Severe, disabling pain and a documented loss of knee function which interferes with the ability to carry out age appropriate activities of daily living and/or demands of employment Knee instability which is noted as giving way weakness, or buckling 10

MRI, Arthroscopy, or Arthrogram demonstrates a tear/disruption or significant laxity of the anterior cruciate ligament Positive Lachman s Test ANY of the following abnormal physical examination findings: o Positive Anterior Drawer Test o Positive Pivot Shift Test o Positive KT arthrometer (>3.5 mm =+1, >5-7 mm = +2, >7 mm =+3) Failure of non-surgical management for at least three (3) months in duration. Anterior cruciate ligament reconstruction with allograft (see above for allograft specific criteria) or autograft is considered medically necessary in an acute injury setting where hemathrosis, effusion, and joint instability have been documented. This may include ANY of the following: A confirmed ACL tear and a repairable meniscus tear Need to return to high demand activities that require cutting, pivoting, and/or agility activities in which ACL insufficiency may predispose to further instability episodes, that may result in new articular or meniscal cartilage injuries Concomitant ligament injuries (i.e., multiligamentous knee injury) that require reconstruction to provide stability. CMM 312: Posterior Cruciate Ligament Reconstruction Guidelines were added for Posterior Cruciate Ligament Reconstruction: Allograft Knee Ligament Reconstruction - Knee ligament reconstruction (i.e., posterior cruciate) using allograft tissue is considered medically necessary for the treatment of ligament injury (e.g., rupture, laxity) when ANY of the following conditions is met: Previous reconstruction has failed and requires revision Surgical reconstruction requires the use of multiple ligament transfers Individual has a medical condition (e.g., anatomic anomaly, prior knee injury or prior knee surgery) that precludes the use of autograft tissue. Knee ligament reconstruction (i.e., posterior cruciate) using allograft tissue for ANY other indication not listed above is considered not medically necessary. Posterior cruciate ligament reconstruction with allograft (see above for allograft specific criteria) or autograft is considered medically necessary when ALL the following criteria have been met: Severe, disabling pain and a documented loss of knee function to an extent which interferes with the ability to carry out the age appropriate activities of daily living and/or demands of employment Individual has undergone an MRI or Arthroscopy or Arthrogram which demonstrates a tear/disruption or significant laxity of the posterior cruciate ligament; 11

Individual demonstrates Positive Posterior Drawer Sign and/or positive Tibial Drop Back Test and/or Quadriceps Active Test either of the following abnormal physical examination findings: o Eight (8) millimeters or more of increased posterior translation on stress radiographs o Positive KT-1000 arthrometer (>7.6 mm of increased posterior translation) Failure of non-surgical care for at least three (3) months in duration Posterior cruciate ligament reconstruction with allograft (see above for allograft specific criteria) or autograft is considered medically necessary in an acute injury setting where hemathrosis, effusion and joint instability have been documented. This may include instances where there are concomitant ligament injuries (i.e., multiligamentous knee) that require reconstruction. CMM 312: Medial Collateral/Lateral Collateral Ligament Repair/Reconstruction Guidelines were added for Medial Collateral/Lateral Collateral Ligament Repair/Reconstruction: Allograft Knee Ligament Reconstruction - Knee ligament reconstruction (i.e., medial collateral, lateral collateral) using allograft tissue is considered medically necessary for the treatment of ligament injury (e.g., rupture, laxity) when ANY of the following conditions is met: Previous reconstruction has failed and requires revision Surgical reconstruction requires the use of multiple ligament transfers Individual has a medical condition (e.g., anatomic anomaly, prior knee injury or prior knee surgery) that precludes the use of autograft tissue. Knee ligament reconstruction (i.e., medial collateral, lateral collateral) using allograft tissue for ANY other indication not listed above is considered not medically necessary. Medial collateral/lateral collateral ligament repair with allograft (see above for allograft specific criteria) or autograft is considered medically necessary when ALL of the following criteria have been met: Severe, disabling pain Loss of knee function which interferes with the ability to carry out age appropriate activities of daily living and/or demands of employment Individual reports knee instability which is noted as giving way weakness or buckling MRI or other diagnostic study demonstrates a tear/disruption of the medial or lateral collateral ligament Positive Valgus Stress Test (Medial), or Varus Stress Test (Lateral) Failure of non-surgical management for at least six (6) weeks duration. Medial collateral or lateral collateral ligament repair/reconstruction with allograft or 12

autograft is considered medically necessary in an acute injury setting where total disruption of the ligament (i.e., multi-ligamentous knee injury) is documented on MRI examination and effusion and joint instability have been documented on physical examination. CMM 312: References Added 1. Crawford DC, Safran MR. Osteochondritis Dissecans of the knee. J Am Acad Orthop Surg, 2006; 14: 90-100. 2. Sherman SL, Garrity J, Bauer K, Cook J et al. Fresh osteochondral allograft transplantation for the knee: current concepts. J Am Acad Orthop Surg 2014 Feb; Vol. 22 (2), pp. 121-33. 3. Graf K, Sekiya J, Wojitys E. Long-term results after combined medial meniscal allograft transplantation and anterior cruciate ligament reconstruction: Minimum 8.5-year follow-up study. Arthroscopy. 2004:20(2):129-140. 4. Linko E, Harilainen A, Malmivaara A, Seitsalo S. Surgical versus conservative interventions for anterior cruciate ligament ruptures in adults. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD001356. 5. Peterson R, Shelton W, Bomboy A. Allograft versus autograft patellar tendon anterior cruciate ligament reconstruction: A 5-year follow-up. Arthroscopy. 2001;17(1):9-13. 6. Sekiya J, Giffin J, Irrgang J, et al. Clinical outcomes after combined meniscal allograft transplantation and anterior cruciate ligament reconstruction. Am J Sports Med. 2003;31(6):896-906. 7. Graf K, Sekiya J, Wojitys E. Long-term results after combined medial meniscal allograft transplantation and anterior cruciate ligament reconstruction: Minimum 8.5-year follow-up study. Arthroscopy. 2004:20(2):129-140. 8. Biau D, Tournoux C, Katsahian Set al. Bone-patellar tendon-bone autografts versus hamstring autografts for reconstruction of anterior cruciate ligament: meta-analysis. BMJ. 2006;332(7548):995-1001. 13

CMM 313: Hip Arthroplasty CMM 313: Age and BMI Previously, patients had to be at least 50 years of age and have a Body Mass Index (BMI) of less than 40 to be considered for partial and total hip arthroplasty. Age and BMI requirements were removed from these guidelines for 2016. CMM 313: Tonnis Grade 3 For Partial Hip Arthroplasty, Tonnis Grade 3 was added as a criterion: Partial hip arthroplasty is considered medically necessary when all of the following criteria have been met: Tonnis Grade 3 osteoarthritis History of chronic severe, disabling pain for at least six (6) months in duration Loss of hip function secondary to osteoarthritis which interferes with the ability to carry out age-appropriate activities of daily living and/or their demands of employment Failure of non-surgical management (e.g., ice, relative rest/activity modification, weight loss, bracing, medications [e.g., anti-inflammatories], injections [steroid] and/or physical therapy) for at least three months. CMM 313: References Added 1. Shimmin A, Beaule PE, Campbell P. Metal-on-metal hip resurfacing arthroplasty. J Bone Joint Surg Am, 2008; 90(3): 637-654. 2. Parker M, Gurusamy K, Azegami S. Arthroplasties (with and without bone cement) for proximal femoral fractures in adults. Cochrane Database Syst Rev. 2010, Issue 6. Art. No.: CD001706. DOI: 10.1002/14651858.CD001706.pub4. 14

CMM 314: Additional Criteria CMM 314: Hip Arthroscopy This policy was reorganized into two sections: 1) indications for non-arthroscopic hip surgery and 2) indications for arthroscopic hip surgery. Additional criteria were added as follows: Non-arthroscopic hip surgery, Hip surgery either arthroscopic or open surgery is considered medically necessary for ANY of the following clinical situations: o Individual has experienced an acute fracture of the hip (femoral or acetabular) o Individual has a mal-union of a previous fracture o Individual has experienced an acute or post traumatic injury in which there is a correlation between examination and diagnostic imaging findings confirming a condition which is reasonably suspected of producing the individual s severe pain and limitation in function o Individual with persistent hip pain or dysfunction of a non-traumatic etiology for at least three (3) months in duration (e.g., avascular necrosis, loose bodies, dysplasia) o Tumor or infection o Femoroacetabular Impingement (FAI) Syndrome, including labral tear or synovial biopsy when an individual has ALL of the following criteria: Positive impingement sign (i.e., sudden pain on 90 degree hip flexion with adduction and internal rotation or extension and external rotation) Moderate to severe hip pain that is worsened by flexion activities (e.g. squatting or prolonged sitting) that significantly limits activities Unresponsive to at least 3 months of physician-directed non-surgical care Radiographic confirmation of FAI (e.g., pistol-grip deformity, alpha angle greater than 50 degrees, coxa profunda, and/or acetabular retroversion) Documented closure of the proximal femoral physis Documented absence of ALL of the following: Tönnis grade 2 osteoarthritis (i.e., small cysts in femoral head or acetabulum, increasing narrowing of joint space, moderate loss of sphericity of femoral head) Tönnis grade 3 osteoarthritis (i.e., large cysts, severe narrowing or obliteration of joint space, severe deformity of femoral head, avascular necrosis Joint space is less than 2 mm wide anywhere along the sourcil Arthroscopic hip surgery is considered medical necessary for ANY of the following clinical situations: o Femoroacetabular Impingement (FAI) Syndrome when an individual has ALL of the following criteria: Positive impingement sign (i.e., sudden pain on 90 degree hip flexion with adduction and internal rotation or extension and external rotation) Moderate to severe hip pain that is worsened by flexion activities (e.g. squatting or prolonged sitting) that significantly limits activities 15

Unresponsive to at least 3 months of physician-directed non-surgical care Radiographic confirmation of FAI (e.g., pistol-grip deformity, alpha angle greater than 50 degrees, coxa profunda, and/or acetabular retroversion) Documented closure of the proximal femoral physis Documented absence of ALL of the following: Tönnis grade 2 osteoarthritis (i.e., small cysts in femoral head or acetabulum, increasing narrowing of joint space, moderate loss of sphericity of femoral head) Tönnis grade 3 osteoarthritis (i.e., large cysts, severe narrowing or obliteration of joint space, severe deformity of femoral head, avascular necrosis Joint space is less than 2 mm wide anywhere along the sourcil o In conjunction with a periacetabular osteotomy o Labral pathology when an individual has ALL of the following criteria: Mechanical symptoms of the hip catching, locking or giving way An advanced diagnostic imaging study confirming labral pathology amenable to surgical management o Synovial biopsy o Irrigation and debridement of an intra-articular joint space infection o Removal of an ossific or osteochondral loose body confirmed radiographically o Arthroscopic hip surgery is considered experimental and investigational for all other indications. CMM 314: References Added 1. Gupta A, Redmond JM, Hammarstedt JE, Lindner D, Stake CE, Domb BG. Does obesity affect outcomes after hip arthroscopy? A cohort analysis. J Bone Joint Surg Am. 2015;97(1):16-23. 16