LCD/NCD Portal

L29005

 

VISCOSUPPLEMENTATION THERAPY FOR KNEE

 

 

08/13/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Indications

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

• The patient is symptomatic.

o Such symptoms may include:

 pain which interferes with the activities of daily living such as:

• Ambulation.

• Prolonged standing.

 Pain interrupting sleep.

 Crepitus.

 Knee stiffness.

• The clinical diagnosis is supported by radiologic evidence of osteoarthritis of the knee such as:

o Joint space narrowing.

o Subchondral sclerosis.

o Osteophytes.

o Sub-chondral cysts.

• If appropriate, other diagnoses have been excluded by appropriate evaluation and management services, laboratory and imaging studies:

o 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.

o Conservative therapy is defined as:

 Nonpharmacological 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

• 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.

o 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.

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

• 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.

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

• Treatment for diagnoses other than those included in the "ICD-9 Codes that Support Medical Necessity" section of this LCD will not be covered.

• Imaging procedures performed routinely for the purpose of visualization of the knee to provide guidance for needle placement will not be covered.

o 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.

o No other imaging modality for the purpose of needle guidance and placement will be covered.

• Arthrography to provide needle guidance for knee injections will not be covered. (See Utilization Guidelines).

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

• Viscosupplementation will not be covered:

o When the diagnosis is anything other than osteoarthritis.

o For intra-articular injection in joints other than the knee.

o As the initial treatment of osteoarthritis of the knee.

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

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

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

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

o For topical application of hyaluronate preparations.

 

 

Coding Information

 

Bill Type Codes

 

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims

 

13x Hospital Outpatient

22x Skilled Nursing - Inpatient (Medicare Part B only)

23x Skilled Nursing - Outpatient

75x Clinic - Comprehensive Outpatient Rehabilitation Facility (CORF)

85x Critical Access Hospital

 

 

Revenue Codes

 

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

0360 Operating Room Services - General Classification

0636 Pharmacy - Drugs Requiring Detailed Coding

 

 

CPT/HCPCS Codes

 

20610 ARTHROCENTESIS, ASPIRATION AND/OR INJECTION; MAJOR JOINT OR BURSA (EG, SHOULDER, HIP, KNEE JOINT, SUBACROMIAL BURSA)

J7321 HYALURONAN OR DERIVATIVE, HYALGAN OR SUPARTZ, FOR INTRA-ARTICULAR INJECTION, PER DOSE

J7323 HYALURONAN OR DERIVATIVE, EUFLEXXA, FOR INTRA-ARTICULAR INJECTION, PER DOSE

J7324 HYALURONAN OR DERIVATIVE, ORTHOVISC, FOR INTRA-ARTICULAR INJECTION, PER DOSE

J7325 HYALURONAN OR DERIVATIVE, SYNVISC OR SYNVISC-ONE, FOR INTRA-ARTICULAR INJECTION, 1 MG

J7326 HYALURONAN OR DERIVATIVE, GEL-ONE, FOR INTRA-ARTICULAR INJECTION, PER DOSE

 

 

ICD-9 Codes that Support Medical Necessity

 

For HCPCS codes J7321, J7323, J7324,J7325, and J7326:

715.16 OSTEOARTHROSIS LOCALIZED PRIMARY INVOLVING LOWER LEG

715.26 OSTEOARTHROSIS LOCALIZED SECONDARY INVOLVING LOWER LEG

715.36 OSTEOARTHROSIS LOCALIZED NOT SPECIFIED WHETHER PRIMARY OR SECONDARY INVOLVING LOWER LEG

715.96 OSTEOARTHROSIS UNSPECIFIED WHETHER GENERALIZED OR LOCALIZED INVOLVING LOWER LEG

 

 

Documentation Requirements

 

• The medical records must document that the patient has symptomatic osteoarthritis of the knee, the nature of the symptoms and the functional limitations.

o Radiographic confirmation in the form of an x-ray report and/or notation in the record must accompany the clinical description.

o The frequency of injections and the dosage given must be clearly indicated.

o The response to treatment must also be noted.

o Repeat courses of viscosupplementation in the absence of documentation of response to the previous course of treatment will be considered not reasonable and necessary and not subject to coverage.

o The record should also indicate whether one or both knees are being treated and in the former instance, which knee is being treated.

• The medical record must include documentation that supports that conservative therapy was attempted prior to viscosupplementation therapy.

o If conservative therapy and/or corticosteroid injections were contraindicated or failed, the reason(s) must be supported in the documentation submitted for review.

 

 

Utilization Guidelines

 

• Additional dosage(s) may be reviewed for medical necessity when the patient receives more than the recommended number of injections.

• In addition, a single course of treatment of either of these medications should be given no more than once every six months.

o Medication: Supartz.

 Weekly Dosage/Injections per week: 25 mg/1.

 Total Dosage: 125 mg.

 Duration of Treatment: 5 weeks/single course of treatment per knee.

o Medication: Synvisc/Hyalan G F.

 Weekly Dosage/Injections per week: 16 mg/1.

 Total Dosage: 48 mg.

 Duration of Treatment: 3 weeks/single course of treatment per knee.

o Medication: Hyalgan

 Weekly Dosage/Injections per week: 20 mg/1.

 Total Dosage: 100 mg.

 Duration of Treatment: 5 weeks/single course of treatment per knee.

o Medication: Orthovisc

 Weekly Dosage/Injections per week: 30 mg/1

 Total Dosage: 90-120 mg

 Duration of Treatment: 3-4 weeks/single course of treatment per knee

o Medication: Euflexxa

 Weekly Dosage/Injections per week: 20 mg/1.

 Total Dosage: 60 mg.

 Duration of Treatment: 3 weeks/single course of treatment per knee.

o Medication: *Synvisc-one/Hyalan

 Weekly Dosage/Injections per week: N/A.

 Total Dosage: 48 mg.

 Duration of Treatment: One time/single course of treatment.

o Medication: *Gel-One®

 Weekly Dosage/Injections per week: N/A.

 Total Dosage: 30 mg.

 Duration of Treatment: One time/single course of treatment.

• 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 27370 (Injection procedure for knee arthrography) or similar services will NOT be covered when billed with HCPCs codes J7321, J7323, J7324, J7325, or J7326.

• The course of treatment should consist of the use of one agent.

o The use of one agent should be used for the entire course of treatment.

o Therefore, initiating a course of treatment with one agent, then switching before completion to a different agent is considered not medically reasonable and necessary.

o 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.

• It is not expected that routine imaging for the purpose of needle guidance would be required.

o Therefore, routine use of fluoroscopy may result in a pre- payment medical review of records.

o Documentation should provide justification when imaging is performed for the purpose of needle guidance.

o The use of hand held ultrasound devices are not separately reimbursed.

• * Synvisc-one/Hyalan and Gel-One® are administered as a single intra-articular injection per course of treatment.

Treatment Logic

• 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.

• 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).

 

 

Sources of Information and Basis for Decision

 

American College of Rheumatology Joint injection/aspiration factsheet retrieved from internet September 20, 2005.

 

Brandt, K.D., and Dieppe, P. (2003). What is important in treating osteoarthritis? Whom should we treat and how should we treat them? Rheumatic Diseases Clinic of North America, Volume 29 Number 4. WB Saunders Company.

 

ESRI Windows on Medical technology: “Hyaluronan-based Therapy for Osteoarthritis of the Knee (Sept. 2001).

 

FCSO LCD 29307, Viscosupplementation Therapy For Knee, 08/13/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Food and Drug Administration (FDA). (2011). Summary of safety and effectiveness data (SSED): Gel-One® http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080020b.pdf?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=gel-one&utm_content=6. Retreived on April 3, 2012

 

Hall S, Buchbinder R. (2004) Do imaging methods that guide needle placement improve outcome? Annals of the Rheumatic Diseases 2004; 63: 1007-1008.

 

Harris, E., (2005) Overview of imaging modalities. Kelley’s Textbook of rheumatology, 7th ed., Elsvier. retrieved from mdconsult.com September 16, 2005.

 

Hyalgan® Sodium Hyaluronate. (2001). Sanofi Pharmaceuticals, Inc. [Package insert, prescribing information]. New York, NY: Author. This source was used to provide indications and limitation on this product.

 

Jackson, Douglas. (2007). Viscosupplementation: Importance of Intra-articular needle placement. http://www.medscape.com/viewarticle/416503_12, retrieved from the internet July 17, 2008.

 

Jackson, D., Evans, N.A., and Thomas, B.A. (2002). Accuracy of needle placement into the intra-articular space of the knee. The Journal of Bone and Joint Surgery, Inc. p. 1522-1527.

 

Jubb RW, Piva S, et al 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. International Journal of Clinical Practice. (2003); 57(6).

 

Kolarz G, Kotz R, and Hochmayer I Long-term benefits and repeated treatment cycles of intra-articular sodium hyaluronate (Hyalgan) in patients with osteoarthritis of the knee. Seminars in Arthritis and Rheumatism (2003) 32:310-319.

 

Neustadt DH Long-term efficacy an safety of intra-articular sodium hyaluronate(Hyalgan®) in patients with osteoarthritis of the knee. Clinical and Experimental Rheumatology. 2003; 21: 307-311

 

Orthovisc® High molecular weight Hyaluronan (2004). OrthoBiotech Products, L.P. [Package insert, prescribing information]. Rarita, N.J: Author. This source was used to provide indications and limitations on this product.

 

SupartzTM Sodium Hyaluronate. (2000). Smith & Nephew, Inc. [Package insert, prescribing information]. Memphis, TN: Author. This source was used to provide indications and limitation on this product.

 

Synvisc® Hylan G-F 20. (2000). Wyeth-Ayerst Pharmaceuticals. [Package insert, prescribing information]. Philadelphia, PA: Author. This source was used to provide indications and limitation on this product.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

CMS LCD VISCOSUPPLEMENTATION THERAPY FOR KNEE