Knee Replacement Surgery Form

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Knee Replacement Surgery Medical Guideline

Service: Knee Replacement Surgery (Total Knee Arthroplasty, Patellofemoral Arthroplasty, Bicompartmental Knee Arthroplasty, and Unicompartmental Knee Arthroplasty) and Pain Associated with Osteoarthritis (OA)

PUM 250-0014-1812

Medical Guideline Committee Approval Q3-2025 Effective Date 03/01/2026

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Related Medical Guidelines:

• Cartilage Transfer Procedures: Osteoarticular Transfer System (OATS) and Mosaicplasty Medical Guideline • Autologous Chondrocyte Implantation (ACI) and Matrix-induced Autologous Chondrocyte Implant (MACI) Medical Guideline • Pneumatic Compression Devices Medical Guideline • Non-covered Services and Procedures Medical Guideline

Coverage for Knee Replacement surgery may vary across plans. Refer to the member’s benefit plan document for coverage details.

Description:

Knee replacement (also called knee arthroplasty) is the replacement of the surfaces of the knee joint that are damaged or diseased with artificial, man-made implants.

 NOTE: Only devices/prosthetics approved by the U.S. FDA (United States Food and Drug Administration) may be used. It is the surgeon’s responsibility to ensure the device/prosthetic used is FDA-approved. See also, Limitations of Coverage.

I. Indications of Coverage:

A. Knee arthroplasty is considered medically necessary for any of the following conditions:

1. Degenerative joint disease (DJD) when ALL of the following (a. through c. below) are met:

   a. The individual has trialed analgesic/anti-inflammatory medication for at least 2 weeks without improvement, unless contraindicated.

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b. Moderate to severe arthritis is shown on radiographic imaging or prior arthroscopy. c. Documentation of one of the following:

i. Average pain level of 6 or greater on a scale of 0 to 10 ii. Intermittent or continuous pain that is causing a functional disability that interferes with ADLs (activities of daily living) iii. Oxford knee score (OKS) of 29 or less

2. Failure of previous knee arthroplasty or osteotomy that is causing pain or functional disability that interferes with ADLs.

3. Revision or replacement of previous knee arthroplasty needed due to loosening or instability of the implant, osteolysis, infection of the artificial joint, periprosthetic fracture, or patellar dislocation.

4. Fracture of proximal tibia or distal femur (or radiographic imaging shows nonunion or malunion of previous fracture) that is causing pain or functional disability that interferes with ADLs.

5. Proximal tibial, distal femur, knee, or adjacent tissue malignancy.

6. Destruction of the knee joint caused by traumatic injury or prior infection.

7. Hemophilic arthropathy or inflammatory arthropathy with documentation of all of the following: Advanced arthritic changes, severely narrowed joint space, decreased range of motion, pain or functional disability that interferes with ADLs, and other surgical interventions (synovectomy, arthrodesis, or osteotomy) are not appropriate or have failed.

8. Congenital deformity that is causing pain or functional disability that interferes with ADLs.

9. Repair of fracture of distal femur due to osteoporosis in elderly individuals when open reduction internal fixation (ORIF) is not appropriate or has been unsuccessful.

   Knee replacement surgery (knee arthroplasty) using an FDA-approved device with customized prosthesis and/or patient specific instruments is considered medically necessary when the above criteria are met and ONE of the following is also met:

   a. Destruction of knee joint caused by traumatic injury, prior infection, or inflammatory/hemophilic arthropathy b. Severe congenital deformity c. Complex peri-articular fracture or fracture through a previous prosthesis.

   For all other indications, use of customized/personalized prostheses and/or patient-specific cutting instruments is considered not medically necessary.

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Imaging studies (CT or MRI) designed to assist with manufacture of custom prostheses or for patient specific instruments will be considered medically necessary only if ONE of the criteria above (a., b., or c.) are met.

NOTE: Please see MCG for surgical setting, length of stay, postoperative rehabilitation or SNF reviews.

Limitations of Coverage:

Benefit Limitations: Please note that in listing services or examples, when we say “this includes,” it is not our intent to limit the description to that specific list. When we do intend to limit a list of services or examples, we state specifically that the list “is limited to.”

1. Review contract and endorsements for exclusions and prior authorization or benefit limits or requirements

2. If used for a condition/diagnosis other than is listed in the Indications of Coverage, it will be considered experimental, investigational, and unproven to affect health outcomes

3. If used for a condition/diagnosis that is listed in the Indications of Coverage, but the criteria are not met, it will be considered not medically necessary

4. All of the following will be considered not medically necessary:

   a. Patient-specific surgical instruments except as noted under Indications of Coverage above. b. Customized knee implants (such as but not limited to Conformis iTotal CR® and other Conformis knee replacement systems) and imaging studies (CT or MRI) designed to assist with manufacture of custom prostheses or for patient specific instruments, or for planning intraoperative navigation; except as noted under Indications of Coverage above.

5. All of the following will be considered experimental, investigational, and unproven to affect health outcomes:

   a. Use of a device/prosthetic that has not been approved by the U.S. FDA for the specific procedure/use planned b. Postoperative prophylactic radiation therapy c. Bi-unicompartmental, bicompartmental, or staged bicompartmental knee arthroplasty d. Home use of CPM (continuous passive motion) devices and related equipment/supplies e. iovera® System f. Unispacer interpositional spacer g. Coolief® Cooled RF (radiofrequency) h. Cryotherapy i. Joint unloading implants for medial knee osteoarthritis (including, but not limited to KineSpring® System and Atlas® Knee System)

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j. Viscosupplementation, hyaluronic acid injections (including, but not limited to Orthovisc®, Synvisc®) k. Stem cell therapy, stem cell injections l. Peripheral nerve block or ablation (not including femoral or adductor canal block) m. Platelet-rich plasma injection(s) n. Genicular nerve blocks/ injections for management of knee pain, unless provided intraoperatively
o. Genicular nerve radiofrequency ablation for management of knee pain p. mi-eye 2 Camera-Enabled Probe (mi-eye 2 arthroscope) q. Intraoperative kinetic balance sensors (such as, but not limited to Verasense®) r. Bone marrow aspirate concentrate (BMAC) injection/treatment s. Microfragmented adipose tissue (MFAT) injection/treatment (such as, but not limited to Lipogems®) t. Platelet Lysate
u. Apos Therapy System x. 3D-print orthopaedic implants
y. Subchondral Calcium Phosphate Injections (subchondroplasty)

6. Intraoperative surgical navigation (e.g., MAKOplasty/MAKO® Tactile Guidance System, KneeAlign® System, iAsssit® Knee System, Velys Digital Surgery ([DePuy Synthes], or other surgical navigation system) or robotic assistance for knee arthroplasty (Mako Robotic assisted surgery) are considered integral to the surgical procedure.

   Documentation Required:

   • Standard Written Order (SWO), prescribed by a qualified healthcare provider concerning the member’s diagnosis.
   • Medical record information (including continued need/use if applicable) and medical necessity. History and physical notes (including documentation of physical/functional impairments and pain caused by knee). Imaging studies.
   Documentation of conservative treatment trials (medication, physical therapy, weight loss [if indicated], etc.). Therapy evaluation and daily progress notes (for review of extensions for inpatient rehabilitation facility or skilled nursing facility) Nursing assessment and progress notes (for review of extensions for skilled nursing facility due to nursing need as indicated in MCG noted above.). • Correct coding for the item/service that meets all the coding guidelines.

   Disclaimer: This guideline is for informational purposes only and does not constitute medical advice, plan authorization, an explanation of benefits, or a guarantee of payment. Benefit plans vary in coverage and some plans may not provide coverage for all services listed in this guideline. Coverage decisions are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations, and to applicable state and federal law. Some benefit plans administered by the organization may not utilize Medical Affairs medical guideline in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information.

   Medical guidelines are based on constantly changing medical science and are reviewed annually and subject to change. The organization uses tools developed by third parties, such as the evidence-based clinical guidelines developed by MCG to assist in administering health benefits. This medical guideline and MCG guidelines are intended to be used in conjunction with the independent professional medical judgment of a qualified health care provider. To obtain additional information about MCG, email medical.policies@wpsic.com. Coverage of all services is subject to medical necessity and services deemed experimental, investigational, and/or unproven are therefore not considered medically necessary under the terms of the clinical guidelines and will not be covered.

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Knee replacement surgery is considered medically necessary only when indicated per the most current medical references and specialty society guidelines, such as MCG, NCCN, etc.

State mandates, laws or benchmark supersede this medical guideline.

Guideline Review History:

Implemented 04/01/19, 01/01/20, 1/1/20, 04/01/21, 12/01/21, 03/01/23, 11/01/24, 03/01/26 Medical Guideline Committee Approval 12/14/18, 09/27/19, 10/30/2020, 11/19/20, 11/18/21, 12/15/22, 12/14/23, 10/31/24, Q3 2025 Reviewed

12/14/18, 09/27/19, 10/30/2020, 11/19/20, 11/18/21, 12/15/22, 12/14/23, 10/31/24, Q3 2025 Developed 12/14/18

Approved by the Medical Director

Codes: The following codes for treatments and procedures applicable to this document are included below for informational purposes.

Code Description 0396T INTRA-OPERATIVE USE OF KINETIC BALANCE SENSOR FOR IMPLANT STABILITY DURING KNEE REPLACEMENT ARTHROPLASTY 0565T AUTOLOGOUS CELLULAR IMPLANT DERIVED FROM ADIPOSE TISSUE FOR THE TREATMENT OF OSTEOARTHRITIS OF THE KNEES; TISSUE HARVESTING AND CELLULAR IMPLANT CREATION (MICROFRAGMENT ADIPOSE TISSUE INJECTION [MFAT]) 0566T AUTOLOGOUS CELLULAR IMPLANT DERIVED FROM ADIPOSE TISSUE FOR THE TREATMENT OF OSTEOARTHRITIS OF THE KNEES; INJECTION OF CELLULAR IMPLANT IN TO KNEE JOINT INCLUDING ULTRASOUND GUIDANCE, UNILATERAL (MICROFRAGMENT ADIPOSE TISSUE INJECTION [MFAT]) 0707T INJECTION(S), BONE-SUBSTITUTE MATERIAL (EG, CALCIUM PHOSPHATE) INTO SUBCHONDRAL BONE DEFECT (IE, BONE MARROW LESION, BONE BRUISE, STRESS INJURY, MICROTRABECULAR FRACTURE), INCLUDING IMAGE GUIDANCE AND ARTHROSCOPIC ASSISTANCE FOR JOINT VISUALIZATION

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64447 INJECTION(S), ANESTHETIC AGENT(S) AND/OR STEROID; FEMORAL NERVE 64450 INJECTION(S), ANESTHETIC AGENT(S) AND/OR STEROID; OTHER PERIPHERAL NERVE OR BRANCH 64454 INJECTION(S), ANESTHETIC AGENT(S) AND/OR STEROID; GENICULAR NERVE BRANCHES, INCLUDING IMAGING GUIDANCE, WHEN PERFORMED 64624 DESTRUCTION BY NEUROLYTIC AGENT, GENICULAR NERVE BRANCHES INCLUDING IMAGING GUIDANCE, WHEN PERFORMED 20985 COMPUTER ASSISTED SURGICAL NAVIGATION PROCEDURE FOR MUSCULOSKELETAL PROCEDURES 27437 ARTHROPLASTY; PATELLA; WITHOUT PROSTHESIS 27438 ARTHROPLASTY, PATELLA; WITH PROSTHESIS 27440 ARTHROPLASTY, KNEE, TIBIAL PLATEAU 27441 ARTHROPLASTY, KNEE, TIBIAL PLATEAU; WITH DEBRIDEMENT AND PARTIAL SYNOVECTOMY 27442 ARTHROPLASTY, FEMORAL CONDYLES OR TIBIAL PLATEAU(S), KNEE 27443 ARTHROPLASTY, FEMORAL CONDYLES OR TIBIAL PLATEAU(S), KNEE; WITH DEBRIDEMENT AND PARTIAL SYNOVECTOMY 27445 ARTHROPLASTY, KNEE, HINGE PROSTHESIS (EG, WALLDIUS TYPE) 27446 ARTHROPLASTY, KNEE, CONDYLE AND PLATEAU; MEDIAL OR LATERAL COMPARTMENT

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27447 ARTHROPLASTY, KNEE, CONDYLE AND PLATEAU; MEDIAL AND LATERAL COMPARTMENTS WITH OR WITHOUT PATELLA RESURFACING (TOTAL KNEE ARTHROPLASTY) 27486 REVISION OF TOTAL KNEE ARTHROPLASTY, WITH OR WITHOUT ALLOGRAFT; 1 COMPONENT 27487 REVISION OF TOTAL KNEE ARTHROPLASTY, WITH OR WITHOUT ALLOGRAFT; FEMORAL AND ENTIRE TIBIAL COMPONENT 27488 REMOVAL OF PROSTHESIS, INCLUDING TOTAL KNEE PROSTHESIS, METHYLMETHACRYLATE WITH OR WITHOUT INSERTION OF SPACER, KNEE 27599 UNLISTED PROCEDURE, FEMOR OR KNEE 0SPC0JZ REMOVAL OF SYNTHETIC SUBSTITUTE FROM RIGHT KNEE JOINT, OPEN APPROACH
0SPD0JZ REMOVAL OF SYNTHETIC SUBSTITUTE FROM LEFT KNEE JOINT, OPEN APPROACH
0SRC0J9 REPLACEMENT OF RIGHT KNEE JOINT WITH SYNTHETIC SUBSTITUTE, CEMENTED, OPEN APPROACH
0SRC0JA REPLACEMENT OF RIGHT KNEE JOINT WITH SYNTHETIC SUBSTITUTE, UNCEMENTED, OPEN APPROACH
0SRD0J9 REPLACEMENT OF LEFT KNEE JOINT WITH SYNTHETIC SUBSTITUTE, CEMENTED, OPEN APPROACH
0SRD0JA REPLACEMENT OF LEFT KNEE JOINT WITH SYNTHETIC SUBSTITUTE, UNCEMENTED, OPEN APPROACH
C8003 IMPLANTATION OF MEDIAL KNEE EXTRAARTICULAR IMPLANTABLE SHOCK ABSORBER SPANNING THE KNEE JOINT FROM DISTAL FEMUR TO PROXIMAL TIBIA, OPEN, INCLUDES MEASUREMENTS, POSITIONING AND ADJUSTMENTS, WITH IMAGING GUIDANCE (E.G., FLUOROSCOPY) C9809 CRYOABLATION NEEDLE (E.G., IOVERA SYSTEM), INCLUDING NEEDLE/TIP AND ALL DISPOSABLE SYSTEM COMPONENTS, NON-OPIOID MEDICAL DEVICE
S2900 SURGICAL TECHNIQUES REQUIRING USE OF ROBOTIC SURGICAL SYSTEM

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