Medical Policy                                                                                                      

Policy Num:       M5.001.001
Policy Name:     Viscosupplementation Therapy For Knee
Policy ID:          [M5.001.001]  [Ac / MA / M+ / P+]  [PI]

Last Review:       May 10, 2024 

Next Review:       May 20, 2025
 

Related Policies: None

Viscosupplementation Therapy For Knee

Summary

Viscosupplementation therapy is part of the therapy used in the treatment of osteoarthritis of the knee. Osteoarthritis results from articular cartilage failure due to the complex interplay of genetic, metabolic, biochemical and biomechanical factors with a secondary component of inflammation. In most patients the initiating mechanism is damage to the articular cartilage either as a single large injury or a series of repeated smaller injuries. The primary symptom of osteoarthritis of the knee is pain, however, because cartilage is aneural, significant radiographic findings are often noted in asymptomatic individuals imaged for other reasons.

Objective

Synthetic hyaluronic preparations used as a viscosupplement are indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics such as acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDS).

Triple S policies adopts Medicare Manual / NCD or  LCD of its applicable contractor in cases were there is a medical criteria declaration. 

Coverage Indications, Limitations, and/or Medical NecessitY

Viscosupplementation therapy for the knee via intra-articular injections of hyaluronic preparations will be considered medically reasonable and necessary when ALL of the following conditions are met:

The patient is symptomatic. Such symptoms may include pain which interferes with the activities of daily living such as ambulation and prolonged standing, or pain interrupting sleep, crepitus, and/or knee stiffness

•The clinical diagnosis is supported by radiologic evidence of osteoarthritis of the knee such as joint space narrowing, subchondral sclerosis, osteophytes and sub-chondral cysts

•If appropriate, other diagnoses have been excluded by appropriate evaluation and management services, laboratory and imaging studies (i.e. the pain and functional disability is not considered likely to be due to a diagnosis other than osteoarthritis of the knee.)

•The patient has failed at least three months of conservative therapy. Conservative therapy is defined as:

·         Nonpharmacologic therapy (such as but not limited to home exercise program, education, weight loss, physical therapy if indicated); and

·         If not contraindicated, simple analgesics and NSAIDS.

•The patient has failed to respond to aspiration of the knee and intra-articular corticosteroid injection therapy when inflammation is a significant component of the patient’s symptoms and intra-articular corticosteroids are not contraindicated.

Limitations

1. Drugs and biologicals approved for marketing by the FDA are considered safe and effective when used for indications specified on the labeling. The labeling lists the safe and effective, i.e., medically reasonable and necessary dosage and frequency. Therefore, doses and frequencies that exceed the accepted standard of recommended dosage and/or frequency, as described in the package insert, are considered not reasonable and necessary and therefore, not subject to coverage.

2. Intra-articular injections of other therapeutic agents, such as corticosteroids, should not be performed in the same knee during the course of viscosupplementation therapy.

3. If the first course of treatment produces relief, subsequent courses of treatment may be reasonable if symptoms return. Subsequent courses of treatment will be allowed six (6) months after the last injection of a previous course of treatment.

4. Viscosupplementation of joints other than the knee(s) will be considered not reasonable and necessary and will not be subject to coverage. 

5. Imaging procedures performed routinely for the purpose of visualization of the knee to provide guidance for needle placement will not be covered. Fluoroscopy may be medically necessary and allowed if documentation supports that the presentation of the patient’s affected knee on the day of the procedure makes needle insertion problematic. No other imaging modality for the purpose of needle guidance and placement will be covered.

6. Arthrography to provide needle guidance for knee injections will not be covered.

7. Coverage of viscosupplementation therapy of the knee assumes that knee arthroplasty is not being considered as a current treatment option.

8. The course of treatment should consist of the use of one agent. One agent should be used for the entire course of treatment. Therefore, initiating a course of treatment with one agent, then switching before completion to a different agent is considered not medically reasonable and necessary. Example: Treatment is initiated with Synvisc. After the application of two doses, the provider switches to Synvisc-one. The Synvisc-one would not be considered medically reasonable and necessary.

9. It is not expected that routine imaging for the purpose of needle guidance would be required. Therefore, routine use of fluoroscopy may result in a pre- payment medical review of records. Documentation should provide justification when imaging is performed for the purpose of needle guidance. The use of hand held ultrasound devices are not separately reimbursed.

10. Viscosupplementation will not be covered:

    • When the diagnosis is anything other than osteoarthritis

    • For intra-articular injection in joints other than the knee

    • As the initial treatment of osteoarthritis of the knee

    • When failure of/or contraindication to conservative therapy and/or corticosteroid injections are not documented in the medical record

    • When the dose and treatment regimen exceeds those approved under the FDA label

    • When a repeat series of injections is initiated prior to six months after completion of the previous course of treatment

    • When a repeat series of injections is administered when there was no symptomatic/functional improvement evidenced from the previous series of injections

    • For topical application of hyaluronate preparations

The following table details the prescribing information for each agent:

BENEFIT APPLICATION

Triple-S Salud Preferred Drugs Determination

Triple-S Salud will consider the following agents as preferred: Hyalgan & Hymovis, Synvisc and Synvisc-One  for shared FDA approved conditions . 

Non-Preferred Agents Step Therapy Criteria

Other Non Preferred Agents may be covered when the criteria listed under Sections A., B., or C. are satisfied:

A. Trial and failure of all of the following: Hyalgan & Hymovis, Synvisc/Synvisc-One, resulting in minimal clinical response to therapy, OR

B. History of intolerance or adverse event to all of the following: Hyalgan & Hymovis, Synvisc/Synvisc-One, OR

C. Continuation of prior therapy within the past 365 days.

Triple S has defined that Medicare Part B coverage may include non-preferred therapies. These non preferred therapies will require prior authorization. Prior authorization for a non-preferred therapy will require history of therapeutic failure of a preferred therapy among other criteria. If a provider administers a non-preferred therapy without obtaining prior authorization, Triple S may deny claims for the non-preferred therapy.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Regulatory Status

Internet Only Manual (IOM) Citations:

CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
Chapter 15, Section 50.1 Definition of Drug or Biological, Section 50.2 Determining Self-Administration of Drug or Biological, paragraph (K) Reasonable and Necessary, Section 50.3 Incident-to Requirements, and Section 50.4 Reasonable and Necessary
CMS IOM Publication 100-08, Medicare Program Integrity Manual,
Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD
Social Security Act (Title XVIII) Standard References:

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. 
Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations. 
Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Supplemental Information

Coding Guidance

Notice: It is not appropriate to bill Medicare for services that are not covered as if they are covered. When billing for non-covered services, use the appropriate modifier.

The physician should indicate which knee is being injected or if both knees are being injected by appropriate modifiers (i.e., LT or RT) on the claim form. For each injection given, the procedure code which accurately reflects the products used and 20610 (Arthrocentesis, aspiration and/or injection, major joint or bursa (e.g., shoulder, hip, knee, subacromial bursa); without ultrasound guidance), may be billed when viscosupplementation of the knee is performed.

Arthrography to provide guidance for injections will not be covered. Therefore, the billing of CPT code 73580 (Radiologic examination, knee, arthrography, radiological supervision and interpretation) and 27369 (Injection procedure for contrast knee arthrography or contrast enhanced CT/MRI knee arthrography) or similar services will not be covered when billed with HCPCs codes J7318, J7320, J7321, J7322, J7323, J7324, J7325, J7326, J7327, J7328, J7329, J7331, and J7332. 

Documentation Requirements

1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
4. The medical records must document that the patient has symptomatic osteoarthritis of the knee, the nature of the symptoms and the functional limitations. 
5. Radiographic confirmation in the form of an x-ray report and/or notation in the record must accompany the clinical description.
6. The frequency of injections and the dosage given must be clearly documented. The response to treatment must also be documented.
7. The record should also indicate whether one or both knees are being treated and in the former instance, which knee is being treated.
8. The medical record must include documentation that supports that conservative therapy was attempted prior to viscosupplementation therapy. If conservative therapy and/or corticosteroid injections were contraindicated or failed, the reason(s) must be supported in the documentation submitted for review.

Utilization Parameters

Please refer to the FDA drug label for the FDA approved indications and dosages. https://labels.fda.gov/

* Synvisc-one/Hyalan, Gel-One® and Monovisc™ are administered as a single intra-articular injection per course of treatment. The other brands are administered as an intra-articular injection over multiple weeks per course of treatment.

Drug Dosing Table

References

First Coast Service Options, Inc., reference LCD number(s) – L29037, L29307, L29408

1. American College of Rheumatology. Joint injection/aspiration Accessed September 20, 2005. 
2. Brandt KD, and Dieppe P. What is important in treating osteoarthritis? Whom should we treat and how should we treat them? Rheum Dis Clin N Am. 2003;29(4):687-716. 
3. ESRI Windows on Medical technology: “Hyaluronan-based Therapy for Osteoarthritis of the Knee". September 2001. 
4. Hall S, Buchbinder R. Do imaging methods that guide needle placement improve outcome? Ann Rheum Dis. 2004; 63(9):1007-1008. 
5. Harris E. Overview of imaging modalities. Kelley’s Textbook of Rheumatology, 7th ed., Elsvier. 2005. Accessed September 16, 2005. 
6. Hyalgan® Sodium Hyaluronate [package insert]. New York, NY: Sanofi Pharmaceuticals, Inc.; 2001. 
7. Hymovis® High Molecular Weight Viscoelastic Hyaluronan (HYADD4®) [package insert]. Brookline, MA: Fidia Farmaceutici S.p.A. 2015. 
8. Jackson D. Viscosupplementation: Importance of Intra-articular needle placement. 2007. Accessed July 17, 2008.
9. Jackson DW, Evans NA, Thomas BM. Accuracy of needle placement into the intra-articular space of the knee. J Bone and Joint Surg, Inc. 2002;84-A(9):1522-1527. 
10. Jubb RW, Piva S, Beinat L, Dacre J, Gishen P. A one-year, randomized, placebo (saline) controlled clinical trial of 500-730 kda sodium hyaluronate (Hyalgan®) on the radiological change in osteoarthritis of the knee. Int J Clin Practice. 2003;57(6):467-474. 
11. Kolarz G, Kotz R, Hochmayer I. Long-term benefits and repeated treatment cycles of intra-articular sodium hyaluronate (Hyalgan®) in patients with osteoarthritis of the knee. Semin Arthritis and Rheum. 2003; 32(5):310-319. 
12. Neustadt DH. Long-term efficacy and safety of intra-articular sodium hyaluronate (Hyalgan®) in patients with osteoarthritis of the knee. Clin Exp Rheumatol. 2003;21:(3)307-311. 
13. Orthovisc® High molecular weight Hyaluronan [package insert]. Rarita, NJ: OrthoBiotech Products, L.P. 2004. 
14. SupartzTM Sodium Hyaluronate [package insert]. Memphis, TN: Smith & Nephew, Inc. 2000. 
15. Synvisc® Hylan G-F 20 [package insert]. Philadelphia, PA: Wyeth-Ayerst Pharmaceuticals. 2000. 
16. S. Food and Drug Administration (FDA). Summary of safety and effectiveness data (SSED): Gel-One®. 2011. Accessed April 03, 2012 
17. S. Food and Drug Administration (FDA). Summary of safety and effectiveness data Monovisc™. 2014. Accessed September 09, 2014. 
18. S. Food and Drug Administration (FDA). Summary of safety and effectiveness data (SSED): Durolane®. 2017. Accessed December 13, 2018. 
19. S. Food and Drug Administration (FDA). Summary of safety and effectiveness data (SSED): TriVisc™. 2017. Accessed December 13, 2018. 
20. S. Food and Drug Administration (FDA). Product information GEL-SYN™. 2014. Accessed November 17, 2016.
21. U.S. Food and Drug Administration (FDA). Full prescribing information GenVisc® 850. (Adant®). 2015. Accessed November 17, 2016.
22. U.S. Food and Drug Administration (FDA). Product information VISCO-3™. 2015. Accessed November 27, 2017.
23. U.S. Food and Drug Administration (FDA). Product information SYNOJOYNT™. 2018. Accessed September 06, 2019.
24. U.S. Food and Drug Administration (FDA). Product information TRILURON™. 2019. Accessed September 06, 2019.
25. https://hcp.hyalgan.com/wp-content/uploads/sites/4/2021/04/684073-F-HYALGAN-Med.-Fronte-Fidia-USA4.pdf
26. https://hymovis.com/wp-content/uploads/2017/04/HYMOVIS_PI.pdf
27. https://products.sanofi.us/synvisc/synvisc.html
28. https://products.sanofi.us/synviscone/synviscone.html
29. https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170007D.pdf
30. https://www.ferringusa.com/wp-content/uploads/sites/12/2024/04/EuflexxaPI-07-2016.pdf
31. https://www.anikaifu.com/wp-content/uploads/2022/02/AML-500-254-Rev-C.pdf
32. https://www.accessdata.fda.gov/cdrh_docs/pdf8/p080020s020d.pdf    
33. https://www.accessdata.fda.gov/cdrh_docs/pdf9/p090031c.pdf    
34. https://www.oakneepainrelief.com/wp-content/uploads/2019/09/GELSYN-3-IFU.pdf    
35. https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160057D.pdf    
36. https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170016D.pdf    
37. https://triluron.com/wp-content/uploads/2020/06/Leaflet-TRILURON-Medico-USA.pdf    
38. https://www.accessdata.fda.gov/cdrh_docs/pdf/P980044b.pdf    
39. https://www.accessdata.fda.gov/cdrh_docs/pdf/p980044s027d.pdf    

Codes

Policy History

PAYMENT POLICY GUIDELINES