Latest Review Date:   January 2024

Category:  Surgical                                                                

POLICY:

These criteria only apply to patients aged 18 years and older.

Medical clearance is required for patients with moderate to severe co-morbid conditions (e.g., cardiac disease, pulmonary disease, or diabetes) for assessment of pre-surgical risk and/or patient’s ability for compliance with postoperative rehabilitation activities.

Knee arthroplasty (total or unicompartmental) may be considered medically necessary for the following indications in the absence of an active infection (local or systemic):

1. Primary or metastatic tumor with limb salvage surgery
2. Extensive disease or damage confirmed by imaging AND documented pain and loss of function due to ONE of the following:
   1. Avascular necrosis
   2. Symptomatic malunion or nonunion of articular fracture (including distal femur or proximal tibia fracture)
   3. Bone-on-bone articulation

3. Persistent, symptomatic degenerative joint disease (DJD), post-traumatic arthritis or rheumatoid arthritis (all confirmed by imaging), when ALL of the following conditions are met:

1. Pain- Documentation of at least TWO of the following:
   1. Pain that interferes with ADLs
   2. Increased pain with activity
   3. Increased pain with weight bearing

AND

2. Motion- Documentation of at least TWO of the following findings on physical examination:
   1. Limited range of motion
   2. Joint effusion or swelling
   3. Crepitus

AND

3. Imaging - Radiographic evidence of severe arthritis as evidenced by the presence of at least TWO of the following:
   1. Joint space narrowing
   2. Subchondral cysts
   3. Subchondral sclerosis
   4. Periarticular osteophytes
   5. Joint subluxation
   6. Marginal erosion (For RA only)

AND

4. Therapy- Documentation of 3 months of unsuccessful conservative therapy including at least ONE of the following:
   1. prescription strength analgesics/anti-inflammatory medications
   2. prescribed topical agents
   3. activity modification
   4. supervised therapeutic exercise
   5. assistive devices
   6. bracing
   7. therapeutic knee injections (as appropriate)

Revision or replacement of arthroplasty may be considered medically necessary for ANY of the following indications when accompanied by pain and functional disability:

1. Confirmed periprosthetic infection by gram stain or culture (pain and functional disability are not required in the presence of confirmed periprosthetic infection);
2. Aseptic loosening of one or more prosthetic components confirmed by imaging;
3. Periprosthetic fracture of distal femur, proximal tibia, patella or any components of the prosthesis confirmed by imaging;
4. Worn bearing surface or plastic insert confirmed by imaging;
5. Progressive or substantial periprosthetic bone loss confirmed by imaging;
6. Malalignment or malposition of prosthesis confirmed by imaging;
7. Knee arthrofibrosis;
8. Instability or dislocation of one or more prosthetic components confirmed by imaging; 
9. Documented persistent knee pain of unknown etiology with gait disturbance.

DESCRIPTION OF PROCEDURE OR SERVICE:

Total knee arthroplasty (TKA) is one of the five most frequently performed inpatient procedures in the United States. In 2010, an estimated 693,400 total knee arthroplasties were performed on individuals aged 45 or older. This number is expected to grow as the population ages with a projected increase to 3.48 million procedures per year by 2030. The vast majority of cases of TKAs are due to degenerative joint disease; osteoarthritis (OA) is the most common form of this condition.

Osteoarthritis

Approximately 14% of U.S. adults will be affected by OA during their lifetime. For individuals over the age of 65 years, the rate of those affected increases to 33.6%. OA is a progressive joint disease that ultimately damages the entire joint, and although disease progression cannot be reversed, conservative treatment can frequently slow or mitigate the progression of the disease. Conservative treatments (non-surgical medical management) may consist of activity modification, anti-inflammatory medications or analgesics, assistive device use, exercise programs, injections, knee braces, orthotics, supervised physical therapy and weight loss. If these measures fail, then TKA may be considered an appropriate option. Thus knee OA should initially be treated conservatively, but surgery may be considered if symptoms persist.

Surgical treatments for knee OA include arthroscopy, osteotomy, and knee arthroplasty; determining which of these procedures is most appropriate will depend on several factors, including the location and severity of OA damage, patient characteristics, and risk factors. The main indication for total knee arthroplasty is for the relief of pain associated with arthritis of the knee which affects 2 or 3 compartments in patients who have failed the aforementioned nonsurgical, conservative treatments. Modern TKA consists of resection of the diseased articular surfaces of the knee, followed by resurfacing with metal and polyethylene prosthetic components. The lifespan of the prosthetic joint is limited and based on variables including patient age, severity of knee disease, comorbidities, obesity, as well as prosthetic and surgical factors.

Conservative Treatment

Before proceeding to total knee arthroplasty for an indication of osteoarthritis, a multifaceted regimen of nonoperative treatment should be attempted. Nonoperative treatments of knee OA are often useful for patients with Kellgren and Lawrence Grades (K-L scores) 1 to 3, which are “early” stages of OA. In this system, Grade 1 is characterized by doubtful joint space narrowing and possible osteophytic lipping; Grade 2, by definite osteophytes and possible joint space narrowing on anteroposterior weight-bearing radiograph; Grade 3, by multiple osteophytes, definite joint space narrowing, sclerosis, and possible bony deformity; and Grade 4, by large osteophytes, marked joint space narrowing, severe sclerosis, and definite bony deformity.

Guidelines from the American Academy of Orthopedic Surgeons (AAOS), the American College of Rheumatology, and the Osteoarthritis Research Society all suggest that patients be offered non-pharmacologic therapy including strengthening, stretching, and conditioning exercises; supervised physical therapy; weight reduction as appropriate; pharmacologic therapy, such as acetaminophen and nonsteroidal anti-inflammatory agents for patients who do not have contraindications; a trial of therapeutic injections; and use of wedge insoles or bracing.

Exercise and muscle strength building programs have been shown to be effective in alleviating some of the symptoms of knee OA including restoring range of motion, alleviating pain, and increasing ability to perform ADLs.

Obesity

An association between obesity (body mass index) and the prevalence and incidence of knee OA has been consistently demonstrated in several cross-sectional and longitudinal studies. Although excess weight increases joint loading, resulting in deleterious effects on weight-bearing joints, this is not the only factor involved in the relationship between OA and obesity. Obesity increases the risk of knee OA by multiple mechanisms: increased joint loading; changes in body composition, with negative effects related to inflammation; and behavioral factors, such as diminished physical activity and subsequent loss of protective muscle strength. Weight loss not only reduces the risk of incident knee OA but, in established disease, also reduces symptoms, improves function, and may reduce disease progression. Furthermore, it is expected that the prevalence of obesity is unlikely to decline and will probably increase the incidence of knee OA and the demand for knee arthroplasty.

Obesity is an independent risk factor for multiple diseases including joint deterioration. Excessive body weight increases the major mechanical load on the knee and contributes to changes in the composition, structure, and mechanical properties of articular cartilage. Within the overall population, the increase in the incidence of total joint arthroplasty parallels the rising rate of obesity. There is a general consensus that the risk of short term post-operative complications increases as weight increases, including wound infections, component malposition and in-hospital mortality. Obesity itself is not an independent risk factor for in-hospital complications and that the multiple comorbidities associated with obesity are significant confounders in many studies.

In addition, there is conflicting evidence regarding whether obese individuals benefit from improved clinical outcomes in the long term. There does appear to be an increased revision rate for overweight or obese individuals five or more years following the initial surgery although this risk appears to be only moderately higher. Obese individuals have reported equivalent or superior clinical outcome satisfaction scores. There appears to be few options for those individuals with DJD who are overweight or obese. While there are many of the studies that recognize the increased complexity related to performing TKAs on this population, the majority of studies recommended not withholding joint replacement surgery for overweight or obese individuals. The American Association of Hip and Knee Surgeons notes that TKA may be considered in obese individuals and states “expectations are for a steady, but slower improvement in the severe obese compared to non-obese patients post operatively”.

Post-traumatic Arthritis

Post-traumatic arthritis (PTA) is a condition triggered by an acute joint trauma that can lead to osteoarthritis or chronic inflammatory arthropathies. This condition can occur at any age, in any joints and may develop from any kind of acute physical trauma, such as sports, vehicle accident, blunt trauma, fall or etc. Although any joint in the body may be involved, PTA is often more notable in weight-bearing joints. A single trauma may sometimes be sufficient to induce arthropathy, however, repeated injuries and excess body weight are known to increase the risk for post-traumatic arthritis. Reconstruction options for symptomatic posttraumatic knee arthritis include osteotomy, arthrodesis, and arthroplasty. Surgical challenges include the presence of extensive (often broken) hardware, scarring, stiffness, bony defects, compromised soft tissues, and malalignment. Patient age and activity and the anatomic location and extent of damage to the articular surface must be taken into account when determining the surgical treatment plan. For younger patients, osteotomy, allograft transplantation, or arthrodesis of the knee is considered, whereas older, low-demand patients are usually treated with arthroplasty.

Rheumatoid Arthritis

Rheumatoid arthritis is a chronic inflammatory and progressive disease characterized by symmetrical joint involvement, which causes pain, swelling, stiffness, and loss of function in the joints. If left untreated, it may lead to joint destruction and progressive disability. Rheumatoid arthritis affects 2.1 million Americans usually striking people between the ages of 20 and 60, and people in their mid to late fifties are especially vulnerable. Rheumatoid arthritis is three times more common in women than in men. The traditional nonsurgical approach consists of non-steroidal anti-inflammatory drugs (NSAIDs) to reduce pain, swelling, and inflammation, plus a disease-modifying antirheumatic drug (DMARD) such as methotrexate to slow the course of the disease and prevent joint and cartilage destruction, physical therapy, or assistive devices. Total knee arthroplasty is considered for individuals who have exhausted other conservative treatment options.

For the properly selected patient, TKA could result in significant pain relief, as well as improved function and quality of life. Despite the potential benefits and successful outcomes, TKA is an elective procedure and should only be considered after extensive discussion of the risks, benefits, and alternatives.

Unicompartmental Knee Replacement

For a small percentage of patients with advanced osteoarthritis limited to a single compartment, a unicompartmental or partial knee replacement may be a treatment option. In this type of surgery, only the damaged knee compartment is replaced with metal and plastic- preserving healthy cartilage, ligaments and bone. Unicompartmental knee replacements are subject to the same criteria requirements as listed below for TKAs.

This policy does not discuss the interpositional unicondylar spacer (e.g., UniSpacer). Refer to medical policy, #125- Unicondylar Interpositional Spacer as a Treatment of Unicompartmental Arthritis of the Knee for information regarding this technology.

KEY POINTS:

Summary of Evidence

Total knee arthroplasty for advanced medial, lateral, or patellofemoral compartment joint disease (e.g., osteoarthritis), is supported with sufficient clinical evidence in the published scientific literature as safe and effective in relieving pain and improving joint function and mobility in patients who have failed nonsurgical medical management. Despite the potential benefits, TKA it is an elective procedure and should only be considered after extensive discussion of the risks, benefits, and alternatives.

After the femoral head, the knee is the second most frequent location for secondary osteonecrosis (approximately 10% of the incidence of the hip). Osteonecrosis of the knee comprises two separate disorders, primary spontaneous osteonecrosis which is often a self-limiting condition and secondary osteonecrosis which is associated with risk factors and a poor prognosis. Despite early intervention with joint-preserving procedures, secondary osteonecrosis often proceeds to degeneration of the joint requiring arthroplasty. Both unicompartmental and total knee arthroplasties may be performed. In a study comparing total knee replacement before and after 1985, significant improvement in outcome results was noted for total knee replacement after 1985 with 97% of patients having a good outcome as indicated by clinician-based assessments and by a 3% revision rate.

There is paucity in the literature regarding the effectiveness of total knee arthroplasty for the treatment of post-traumatic arthritis (PTA). PTA refers to structural damage following an injury to an articulating joint. It commonly affects younger, more active individuals as they are more likely to participate in such activities that may cause injury (i.e., sports, blunt trauma, motor vehicle accidents, etc.). It is estimated that 12% of all symptomatic osteoarthritis (OA) of the hip, knee, and ankle are due to PTA. In regards to treatment of PTA, conservative management, including activity modification, anti-inflammatory medications, ambulatory assist devices, and physical therapy are exhausted before proceeding to surgical option. Surgical management ranges from arthroscopic debridement to arthrodesis. Total knee arthroplasty is an option for the treatment of end-stage PTA. Compared to TKA for patients with primary OA, TKA performed for PTA is often more technically challenging due to previous surgeries and scarring, uses more hospital resources, and incurs a higher cost. Although associated with higher complication rates, TKA is an effective treatment for PTA, as it improves ROM, pain and functional outcomes.

Total knee arthroplasty in patients with rheumatoid arthritis (RA) presents several unique challenges. Patients with RA often have additional medical, anesthetic, and global musculoskeletal problems that are not present in the patient with osteoarthritis. Regarding the knee, these patients usually have osteopenia and may present with an array of bone and soft tissue deformities, each of which can impact the initial success and long term durability of a total knee replacement. Despite these potential difficulties, the early and long term results of total knee arthroplasty in patients with rheumatoid arthritis have a reported success rate for in excess of 85% at 10 years.

Primary cemented arthroplasty of the knee is a viable alternative to open reduction and internal fixation (ORIF) for treatment of osteoporotic fractures about the knee. This permits early return of knee function and weight bearing activity. Stemmed revision total knee arthroplasty implants and techniques are needed, which can be associated with complications of late loosening and periprosthetic fracture. However, for elderly sedentary patients who would not be expected to outlive the durability of the arthroplasty and with fracture patterns in which ORIF may be associated with poor outcomes, primary arthroplasty can be a favorable treatment option.

The use of knee arthroplasty to reconstruct a knee following the diagnosis of a primary or metastatic tumor has largely replaced amputation as the treatment of choice. In appropriate candidates, arthroplasty in limb salvage can allow the individual to retain a higher level of function.

Failure of a total knee replacement may require revision, which has been successful for many individuals. Evidence of progressive and substantial bone loss alone is sufficient reason to consider revision in advance of catastrophic prosthesis failure. Fracture or dislocation of the patella, instability of the components or aseptic loosening, infection, and periprosthetic fractures are common reasons for total knee revision.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Total knee replacement, total knee arthroplasty, TKA, patella arthroplasty, degenerative joint disease, DJD, knee osteoarthritis, unicompartmental knee replacement, partial knee replacement, knee revision, avascular necrosis of knee, osteonecrosis of knee, post-traumatic arthritis

APPROVED BY GOVERNING BODIES:

Knee replacement surgery is a procedure and therefore is not regulated by the FDA. However, devices and instruments used during the surgery require FDA approval. See the following website for additional information (product codes MBH, JWH, KRO): www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.

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. American Academy of Orthopedic Surgeons. Management of Osteoarthritis of the Knee (Non-Arthroplasty). Evidence-based clinical practice guideline August 31, 2021. www.aaos.org/globalassets/quality-and-practiceresources/osteoarthritis-of-the-knee/oak3cpg.pdf.
2. American Academy of Orthopaedic Surgeons (AAOS). OrthoInfo: Arthritis of the knee. February 2023. orthoinfo.aaos.org/topic.cfm?topic=A00212.
3. American Academy of Orthopaedic Surgeons. Total Knee Replacement. June 2020. orthoinfo.aaos.org/en/treatment/total-knee-replacement/
4. American Academy of Orthopaedic Surgeons. Treatment of osteoarthritis of the knee. 2013, 2nd edition. www.aaos.org/globalassets/quality-and-practice-resources/osteoarthritis-of-the-knee/osteoarthritis-of-the-knee-2nd-editiion-clinical-practice-guideline.pdf
5. Beard D, Price A, Cook J, et al. Total or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial. Trials. 2013; 14:292.
6. Bohm ER, Tufescu TV, Marsh JP. The operative management of osteoporotic fractures of the knee: to fix or replace? Journal of Bone and Joint Surgery. British Volume 2012; 94(9):1160-1169
7. Bolognesi MP, Greiner MA, Attarian DE, et al. Unicompartmental knee arthroplasty and total knee arthroplasty among Medicare beneficiaries, 2000 to 2009. J Bone Joint Surg Am. 2013; 95(22):e174.
8. Carr AJ, Robertsson O, Graves S et al. Knee replacement. Lancet. 2012; 379(9823):1331-1340.
9. Cross MB, Berger R. Feasibility and safety of performing outpatient unicompartmental knee arthroplasty. Int Orthop. 2014; 38(2):443-447.
10. D'Apuzzo MR, Novicoff WM, Browne JA. The John Insall Award: Morbid obesity independently impacts complications, mortality, and resource use after TKA. Clin Orthop Relat Res. 2015; 473(1):57-63.
11. Dusad A, Pedro S, Mikuls TR, Hartman CW, Garvin KL, O'Dell JR, Michaud K. Impact of total knee arthroplasty as assessed using patient-reported pain and health-related quality of life indices: Rheumatoid arthritis versus osteoarthritis. Arthritis Rheumatol. 2015; 67(9):2503.
12. Hamilton DF, Howie CR, Burnett R, et al. Dealing with the predicted increase in demand for revision total knee arthroplasty: challenges, risks and opportunities. Bone Joint J. 2015; 97-B(6):723-728.
13. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
14. Jennings JM, Kleeman-Forsthuber K, Bolognesi MP. Medial unicompartmental arthroplasty of the knee. J Am Acad Orthop Surg. 2019;27: 166-76.
15. Jorge RT, Souza MC, Chiari A, et al. Progressive resistance exercise in women with osteoarthritis of the knee: a randomized controlled trial. Clin Rehabil. 2015; 29(3):234-243.
16. Kim KT, Lee S, Kim JH, et al. The Survivorship and Clinical Results of Minimally Invasive Unicompartmental Knee Arthroplasty at 10-Year Follow-up. Clin Orthop Surg. 2015; 7(2):199-206.
17. Kristensen PW, Holm HA, Varnum C. Up to 10-year follow-up of the Oxford medial partial knee arthroplasty--695 cases from a single institution. J Arthroplasty. 2013; 28(9 Suppl):195-198.
18. Kulkarni K, Karssiens T, Kumar V, Pandit H. Obesity and osteoarthritis. Maturitas. 2016 Jul;89: 22-28.
19. Kuwashima U, Okazaki K, Tashiro Y, et al. Correction of coronal alignment correlates with reconstruction of joint height in unicompartmental knee arthroplasty. Bone Joint Res. 2015; 4(8):128-133.
20. Liddle AD, Judge A, Pandit H, Murray DW. Adverse outcomes after total and unicompartmental knee replacement in 101 330 matched patients: a study of data from the National Joint Registry for England and Wales. Lancet. 2014 Jul 7.
21. Manzotti A, Cerveri P, Pullen C, et al. A flat all-polyethylene tibial component in medial unicompartmental knee arthroplasty: a long-term study. Knee. 2014; 21 Suppl 1:S20-5.
22. Martin GM, Harris, I. Total knee arthroplasty. UpToDate. Sept 12, 2023.
23. McElroy MJ, Pivec R, Issa K, et al. The effects of obesity and morbid obesity on outcomes in TKA. J Knee Surg. 2013; 26(2):83-88.
24. Miniaci A. UniCAP as an alternative for unicompartmental arthritis. Clinics in Sports Medicine. 33 (1) (pp 57-65), 2014.
25. Murphy, L., Helmick, CG. The impact of osteoarthritis in the United States: A population-health perspective. AM J Nurs. 2012; 112(3 Suppl 1):S13-19.
26. Murray DW, MacLennan GS, Breeman S, et al. A randomised controlled trial of the clinical effectiveness and cost-effectiveness of different knee prostheses: the Knee Arthroplasty Trial (KAT). Health Technol Assess. 2014; 18(19):1-235, vii-viii.
27. National Institute for Health and Care Excellence (NICE). Osteoarthritis in over 16s: diagnosis and management. NICE guideline (NG226). Published October 19, 2022. www.nice.org.uk/guidance/ng226/resources/osteoarthritis-in-over-16s-diagnosis-and-management-pdf-66143839026373
28. National Institutes of Health Consensus Panel. NIH Consensus Statement on total knee replacement December 8-10, 2003. J Bone Joint Surg Am. 2004; 86-(6):1328-1335.
29. Niinimäki T, Eskelinen A, Mäkelä K, et al. .Unicompartmental knee arthroplasty survivorship is lower than TKA survivorship: a 27-year Finnish registry study. Clin Orthop Relat Res. 2014; 472(5):1496-501.
30. Perry KI, MacDonald SJ. The obese patient: a problem of larger consequence. Bone Joint J. 2016;  98-B(1 Suppl A):3-5.
31. Pitta, Michael et al. Failure after modern total knee arthroplasty: A prospective study of 18,065 knees. J Arthroplasty. 2018; 33(2):407-414.
32. Punzi L, Galozzi P, Luisetto R, et al. Posttraumatic arthritis: overview on pathogenic mechanisms and role of inflammation. RMD Open 2016; 2:e000279.
33. Richmond JC. Surgery for osteoarthritis of the knee. Rheumatic Disease Clinics of North America. 2013; 39(1):203-211.
34. Ries MD. Primary arthroplasty for management of osteoporotic fractures about the knee. Current Osteoporosis Reports. 2012; 10(4):322-327.
35. Saleh H, Yu S, Vigdorchik J, Schwarzkopf R. Total knee arthroplasty for treatment of post-traumatic arthritis: Systematic review. World Journal of Orthopedics. 2016; 7(9):584-591.
36. Sharkey, Peter F. et al. Why are total knee arthroplasties failing today: Has anything changed in 10 years? J Arthroplasty. 2014; 29(9): 1774–1778.
37. Si HB, Zeng Y, Shen B, et al. The influence of body mass index on the outcomes of primary total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015; 23(6):1824-1832.
38. Skou ST, Roos EM, Laursen MB, et al. A randomized, controlled trial of total knee replacement. N Engl J Med. 2015; 373(17):1597-1606.
39. Smith JR, Robinson JR, Porteous AJ, et al. Fixed bearing lateral unicompartmental knee arthroplasty-Short to midterm survivorship and knee scores for 101 prostheses. Knee. 2014 Aug; 21(4):843-847.
40. Strauss AC, et al. Outcome after total knee arthroplasty in haemophilic patients with stiff knees. Haemophilia. 2015; 21:e300.
41. Suleiman LI, Ortega G, Ong'uti SK, et al. Does BMI affect perioperative complications following total knee and hip arthroplasty? J Surg Res. 2012; 174(1):7-11.
42. Tanaka R, Ozawa J, Kito N, Moriyama H. Efficacy of strengthening or aerobic exercise on pain relief in people with knee osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2013; 27912):1059-1071.
43. Thambapillary S, Dimitriou R, Makridis KG, et al. Implant longevity, complications and functional outcome following proximal femoral arthroplasty for musculoskeletal tumors: a systematic review. J Arthroplasty. 2013; 28(8):1381-1385.
44. Werner BC, Kurkis GM, Gwathmey FW, Browne JA. Bariatric surgery prior to total knee arthroplasty is associated with fewer postoperative complications. J Arthroplasty. 2015; 30(9 Suppl):81-85.
45. Wluka AE, Lombard CB, Cicuttini FM. Tackling obesity in knee osteoarthritis. Nat Rev Rheumatol. 2013 Apr; 9(4):225-235.
46. Workgroup of the American Association of Hip and Knee Surgeons Evidence Based Committee. Obesity and total joint arthroplasty: a literature based review. J Arthroplasty. 2013; 28(5):714-721.
47. Zhou ZY, Liu YK, Chen HL, et al. Body mass index and knee osteoarthritis risk: a dose-response meta-analysis. Obesity (Silver Spring). 2014; 22(10):2180-2185.

POLICY HISTORY:

Medical Policy Group, February 2018 (7): New policy addressing knee arthroplasty.

Medical Policy Administration Committee, March 2018

Available for comment March 2 through April 30, 2018

Medical Policy Group, August 2018 (7): Effective date, “on or after November 1, 2018,” added to Policy Statement.

Medical Policy Group, October 2019 (7): Reviewed by consensus. No change to Policy Statement. No new literature to add.

Medical Policy Group, August 2021 (7): Reviewed by consensus. Literature review completed. Reference added. No change to Policy Statement.

Medical Policy Group, January 2023 (7): Reviewed by consensus. Literature review completed. References added. No change to Policy Statement.

Medical Policy Group, January 2024 (7): Reviewed by consensus. Literature review completed. Update to Benefit Application and References. No change to 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.