Prtcl: ORT015 Effective Date: June 1, 2016 HIP REPLACEMENT SURGERY (ARTHROPLASTY) Table f Cntents Page COMMERCIAL & MEDICAID COVERAGE RATIONALE... 1 MEDICARE COVERAGE RATIONALE... 3 U.S.FOOD AND DRUG ADMINISTRATION (FDA)... 5 APPLICABLE CODES... 5 PROTOCOL HISTORY/REVISION INFORMATION... 6 INSTRUCTIONS FOR USE This prtcl prvides assistance in interpreting UnitedHealthcare benefit plans. When deciding cverage, the enrllee specific dcument must be referenced. The terms f an enrllee's dcument (e.g., Certificate f Cverage (COC) r Evidence f Cverage (EOC)) may differ greatly. In the event f a cnflict, the enrllee's specific benefit dcument supersedes this prtcl. All reviewers must first identify enrllee eligibility, any federal r state regulatry requirements and the plan benefit cverage prir t use f this Prtcl. Other Prtcls, Plicies and Cverage Determinatin Guidelines may apply. UnitedHealthcare reserves the right, in its sle discretin, t mdify its Prtcls, Plicies and Guidelines as necessary. This prtcl is prvided fr infrmatinal purpses. It des nt cnstitute medical advice. This plicy des nt gvern Medicare Grup Retiree members. UnitedHealthcare may als use tls develped by third parties, such as the MCG Care Guidelines, t assist us in administering health benefits. The MCG Care Guidelines are intended t be used in cnnectin with the independent prfessinal medical judgment f a qualified health care prvider and d nt cnstitute the practice f medicine r medical advice. COMMERCIAL & MEDICAID COVERAGE RATIONALE Fr infrmatin regarding medical necessity review, when applicable, see MCG Care Guidelines, 20th Editin, 2016 Hip Arthrplasty, S-560 (ISC), accessed April 2016. MCG Care Guidelines: Hip Arthrplasty, S-560 Clinical Indicatins fr Prcedure: Prcedure may be indicated fr 1 r mre f the fllwing: Degenerative jint disease is needed as indicated by ALL f the fllwing: Presence f significant radigraphic findings (eg, hip jint destructin, severe narrwing, bne defrmities, stenecrsis) Optimal medical management has been tried and failed. Patient has failed r is nt a candidate fr mre cnservative measures (eg, stetmy, hemiarthrplasty). Hip Replacement Surgery (Arthrplasty) Page 1 f 6
Treatment is needed because f 1 r mre f the fllwing: Disabling pain Functinal disability Primary and secndary tumrs invlving the prximal femur Ostenecrsis f femral head Develpmental dysplasia f hip Displaced fracture f the femral neck in a patient withut significant cgnitive impairment Acetabular fracture Failed previus hip fracture fixatin Revisin f hip arthrdesis Revisin f previus arthrplasty r resurfacing indicated by 1 r mre f the fllwing: Instability f ne r bth cmpnents Fracture r mechanical failure f the implant Recurrent r irreducible dislcatin Infectin Treatment f a displaced periprsthetic fracture Tissue r systemic reactin t metal implant Criteria Multivariate adjusted analysis f a database including 3421 surgens, 312 hspitals, and 182,146 patients reprted that high surgen vlume (median 278 prcedures a year) f ttal hip r knee arthrplasty was independently assciated with lwer risk f surgical cmplicatins, lwer rates f readmissin and reperatin, shrter lengths f hspital stay, and higher likelihds f being discharged t hme rather than t a skilled nursing r rehabilitatin facility. In this same analysis, cmpared with lw hspital vlume (median 181 patients a year), high hspital vlume (median 1007 patients a year) was independently assciated with lwer risk f mrtality, lwer risk f readmissin, and higher likelihd f being discharged hme. Systematic reviews and meta-analyses f randmized cntrlled trials reprted that, cmpared with pen reductin and internal fixatin r hemiarthrplasty, ttal hip arthrplasty resulted in imprved clinical utcmes in elderly patients with a displaced femral neck fracture and withut significant cgnitive impairment. A chrt analysis f mre than 2600 patients underging either bilateral simultaneus r unilateral ttal hip arthrplasty fund similar rates f periperative mrtality and pstperative cmplicatins in bth grups but lnger lengths f stay and a higher rate f bld transfusins in the bilateral grup. **End f MCG Fr infrmatin regarding medical necessity review, when applicable, see MCG Care Guidelines, 20th Editin, 2016, Hip: Displaced Fracture f Femral Neck, Hemiarthrplasty, S-600 (ISC), accessed April 2016. MCG Care Guidelines: Hip: Displaced Fracture f Femral Neck, Hemiarthrplasty, S-600 (ISC) Clinical Indicatins fr Prcedure Prcedure is indicated fr 1 r mre f the fllwing: Displaced fracture f femral neck in lder patient (eg, 65 years r lder) Fracture-dislcatin f hip in lder patient (eg, 65 years r lder) Reductin r fixatin f hip fracture that cannt be maintained Hip Replacement Surgery (Arthrplasty) Page 2 f 6
Recent histry f failed fixatin f femral neck fracture Fracture f neck f femur with cmplete dislcatin f femral head Fracture superimpsed upn pre-existing lesins f hip (eg, radiatin changes, severe arthritis) Fracture f femral neck in patient with psychsis r severe cgnitive impairment Pathlgic fracture f femral neck Criteria Analysis f mre than 97,000 patients treated surgically fr hip fracture fund, after multivariate analysis, that high surgen vlume (greater than 15 prcedures per year) and high hspital vlume (greater than 132 prcedures per year) are independently assciated with reduced length f stay. In the same analysis, high surgen vlume was independently assciated with reduced inpatient mrtality, and bth high surgen and high hspital vlume were independently assciated with reduced pstperative mrbidity (eg, need fr bld transfusin, pstperative infectin). A systematic review and meta-analysis f 20 randmized cntrlled trials (4509 patients) fund that arthrplasty (hemi r ttal) led t imprved hip functin, decreased pain, and decreased need fr reperatin when cmpared t internal fixatin and repair in patients with a displaced femral neck fracture. A systematic review and meta-analysis f 12 randmized cntrlled studies (1320 patients) with displaced femral neck fractures fund that ttal hip arthrplasty resulted in higher hip functinal scres and a lwer risk f subsequent reperatin but in greater dislcatin rates when cmpared t hemiarthrplasty. A study f 2056 patients (mean age 81 years) with hip fracture fund, after multivariate adjustment, that each 12- hur delay frm admissin t surgery was independently assciated with an increased rate f inhspital mrtality. A systematic review and meta-analysis f 35 studies including 191,873 hip fracture patients fund that a shrter time interval t surgery was assciated with decreased mrtality, and that this assciatin persisted when analysis was limited t studies that emplyed adjustment fr cnfunding variables. ***End f MCG MEDICARE COVERAGE RATIONALE Medicare des nt have a Natinal Cverage Determinatin, but des have a Lcal Cverage Determinatin fr Nevada fr Ttal Jint Arthrplasty (L34163) (Accessed April 2016). Ttal Jint Arthrplasty (L34163) Ttal Hip Arthrplasty (THA) Ttal hip replacement surgery is medically necessary when ne r mre f the fllwing criteria* are met: Advanced jint disease demnstrated by: Radigraphic supprted evidence r when cnventinal radigraphy is nt adequate, magnetic resnance imaging (MRI) supprted evidence (subchndral cysts, subchndral sclersis, periarticular stephytes, jint subluxatin, jint space narrwing, avascular necrsis); and Pain that cannt be adequately cntrlled despite ptimal cnservative treatment r functinal disability frm injury due t trauma r arthritis f the jint); and If apprpriate, histry f unsuccessful cnservative therapy (nn-surgical medical management) that is clearly addressed in the pre prcedure medical recrd. (If cnservative Hip Replacement Surgery (Arthrplasty) Page 3 f 6
therapy is nt apprpriate, the medical recrd must clearly dcument the ratinale fr why such apprach is nt reasnable); r Malignancy f the jint invlving the bnes r sft tissues f the pelvis r prximal femur; r Avascular necrsis (stenecrsis f femral head); r Fracture f the femral neck; r Acetabular fracture; r Nn-unin r failure f previus hip fracture surgery; r Mal-unin f acetabular r prximal femur fracture *See Assciated Infrmatin Dcumentatin Requirements fr additinal infrmatin. Nn-surgical medical management is usually but nt always implemented prir t scheduling ttal jint surgery. Nn-surgical treatment as clinically apprpriate fr the patient s current episde f care typically includes ne r mre f the fllwing: anti-inflammatry medicatins r analgesics, r flexibility and muscle strengthening exercises, r supervised physical therapy [Activities f daily living (ADLs) diminished despite cmpleting a plan f care], r assistive device use, r weight reductin as apprpriate, r therapeutic injectins int the hip as apprpriate. Indicatins fr Replacement/Revisin f Ttal Hip Arthrplasty Lsening f ne r bth cmpnents; r Fracture r mechanical failure f the implant; r Recurrent r irreducible dislcatin; r Infectin; r Treatment f a displaced periprsthetic fracture; r Clinically significant leg length inequality nt amenable t cnservative management; r Prgressive r substantial bne lss; r Bearing surface wear leading t symptmatic synvitis r lcal bne r sft tissue reactin; r Clinically significant audible nise; r Adverse lcal tissue reactin Limitatins Ttal knee replacement r ttal hip replacement is nt medically necessary when the fllwing cntraindicatins are present: Active infectin f the hip r knee jint r active systemic bacteremia Active skin infectin (exceptin recurrent cutaneus staph infectins) r pen wund within the planned surgical site f the hip r knee Rapidly prgressive neurlgical disease except in the clinical situatin f a cncmitant displaced femral neck fracture Hip Replacement Surgery (Arthrplasty) Page 4 f 6
The fllwing cnditins are relative cntraindicatins t ttal knee r ttal hip replacement and if such surgery is perfrmed in the presence f these cnditins, it is expected that the ratinale fr prceeding with the surgery under such circumstances is clearly dcumented in the medical recrd: Absence r relative insufficiency f abductr musculature Any prcess that is rapidly destrying bne Neurtrphic arthritis Fr Medicare and Medicaid Determinatins Related t States Outside f Nevada: Please review Lcal Cverage Determinatins that apply t ther states utside f Nevada. http://www.cms.hhs.gv/mcd/search Imprtant Nte: Please als review lcal carrier Web sites in additin t the Medicare Cverage database n the Centers fr Medicare and Medicaid Services Website. U.S.FOOD AND DRUG ADMINISTRATION (FDA) Hip replacement surgery is a prcedure and therefre is nt regulated by the FDA. Hwever, devices and instruments used during the surgery require FDA apprval. Several devices have FDA apprval. Additinal infrmatin (prduct cde MEH, JDI, JDG, LWJ, LPH, LZO, KWY, KWA) is available at: http://www.accessdata.fda.gv/scripts/cdrh/devicesatfda/index.cfm. Accessed April 2016. The FDA-apprved ttal hip arthrplasty (THA) devices are generally apprved fr the same indicatins, including any r all f the fllwing: Severe hip pain and disability due t stearthritis (OA), rheumatid arthritis (RA), traumatic arthritis (TA), plyarthritis, cllagen disrders, avascular necrsis f the femral head, r nnunin f prir femral fracture. Cngenital hip dysplasia, prtrusia acetabuli (bulging f the femral head int the pelvis), r slipped capital femral epiphysis. Disability due t previus fusin. Acute femral neck fracture. NOTE: Mre than 80 FDA-apprved THA devices have been recalled since January 2004. In general, THA devices have been recalled due t manufacturing defects r high rates f early revisin surgery. See the fllwing fr mre infrmatin: Center fr Devices and Radilgical Health (CDRH). Medical & Radiatin Emitting Device Recalls Database [search: hip implant]. Fd and Drug Administratin [web site]. Available at: http://www.accessdata.fda.gv/scripts/cdrh/cfdcs/cfres/res.cfm. Accessed April 2016. APPLICABLE CODES The Current Prcedural Terminlgy (CPT ) cdes and Healthcare Cmmn Prcedure Cding System (HCPCS) cdes listed in this plicy are fr reference purpses nly. Listing f a service cde in this plicy des nt imply that the service described by this cde is a cvered r nn-cvered health service. Cverage is determined by the enrllee specific benefit dcument and applicable laws that may require cverage fr a specific service. The inclusin f a cde des nt imply any right t Hip Replacement Surgery (Arthrplasty) Page 5 f 6
reimbursement r guarantee claims payment. Other plicies and cverage determinatin guidelines may apply. This list f cdes may nt be all inclusive. CPT Cdes Descriptin 27120 Hip Acetabulplasty; (e.g., Whitman, Clnna, Haygrves, r cup type) 27122 Hip Acetabulplasty; resectin, femral head (e.g., Girdlestne prcedure) 27125 Hip Hemiarthrplasty, hip, partial (e.g., femral stem prsthesis, biplar arthrplasty) 27130 Hip Arthrplasty, acetabular and prximal femral prsthetic replacement (ttal hip arthrplasty), with r withut autgraft r allgraft 27132 Hip Cnversin f previus hip surgery t ttal hip arthrplasty, with r withut autgraft r allgraft 27134 Hip Revisin f ttal hip arthrplasty; bth cmpnents, with r withut autgraft r allgraft 27137 Hip Revisin f ttal hip arthrplasty; acetabular cmpnent nly, with r withut autgraft r allgraft 27138 Hip Revisin f ttal hip arthrplasty; femral cmpnent nly, with r withut allgraft CPT is a registered trademark f the American Medical Assciatin PROTOCOL HISTORY/REVISION INFORMATION Date 04/28/2016 06/25/2015 09/25/2014 05/22/2014 12/19/2013 02/28/2013 04/26/2012 02/23/2012 Actin/Descriptin Crprate Medical Affairs Cmmittee The freging Health Plan f Nevada/Sierra Health & Life Health Operatins prtcl has been adpted frm an existing UnitedHealthcare cverage determinatin guideline that was researched, develped and apprved by the UnitedHealthcare Cverage Determinatin Cmmittee. Hip Replacement Surgery (Arthrplasty) Page 6 f 6