L29005-LCD

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Local Coverage Determination (LCD) for Viscosupplementation Therapy For Knee (L29005)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L29005

LCD Title Viscosupplementation Therapy For Knee

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

Contractor's Determination Number AVISCO

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/16/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 08/13/2012

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.2k

CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 5.1

Transmittal 1139, Change Request 5438, dated 12/22/2006

Indications and Limitations of Coverage and/or Medical Necessity

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).

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. 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:

o Nonpharmacologic therapy (such as but not limited to home exercise program, education, weight loss, physical therapy if indicated); and o 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. Therefore, doses and frequences 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. Flouroscopy 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.

• 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.

013x Hospital Outpatient

022x Skilled Nursing - Inpatient (Medicare Part B only) 023x Skilled Nursing - Outpatient

075x Clinic - Comprehensive Outpatient Rehabilitation Facility (CORF) 085x 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, 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

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

The medical records must document that the patient has symptomatic osteoarthritis of the knee, the nature of the symptoms and the functional limitations. Radiographic confirmation in the form of an x-ray report and/or notation in the record must accompany the clinical description. The frequency of injections and the dosage given must be clearly indicated. The response to treatment must also be noted. 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. 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. If conservative therapy and/or corticosteroid injections were contraindicated or failed, the reason(s) must be supported in the documentation submitted for review.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

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.

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

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

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

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

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

Medication: *Synvisc-one/Hyalan

Weekly Dosage/Injections per week: N/A Total Dosage: 48 mg

Duration of Treatment: One time/single course of treatment

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. The use of 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.

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.

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

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). 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.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 01/01/2010

Revision History Number 5

Revision History Explanation Revision Number:5 Start Date of Comment Period:N/A

Start Date of Notice Period:07/01/2012 Revised Effective Date: 08/13/2012

LCR A2012-045

June 2012 Connection

Explanation of Revision: HCPCS code J7326 (Hyaluronan or derivative, Gel-One, for intra-articular injection, per dose) was added to the “CPT/HCPCS Codes” and “Utilization Guidelines” sections of the LCD. In addition, the “Sources of Information and Basis for Decision” section of the LCD was also updated. The effective date of this revision is based on date of service.

Revision Number:4

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2010 Revised Effective Date: 01/01/2010

LCR A2010-013

December 2009 Bulletin

Explanation of Revision: Annual 2010 HCPCS Update. Added HCPCS code J7325. Deleted HCPCS codes J7322. The effective date of this revision is based on date of service.

Revision Number:3

Start Date of Comment Period:N/A Start Date of Notice Period:12/01/2009 Revised Effective Date: 11/05/2009

LCR A2009-090

November 2009 Bulletin

Explanation of Revision: Deleted C9399 for billing Synvisc-one. Added parenthetical explanation under J7322 in the “CPT/HCPCS Codes” section for its use when billing Synvisc-one. This revision is effective for dates of service 02/26/09-12/31/09. Revised “utilization guidelines” section of the LCD with statement regarding the switching of viscosupplementation agents during course of treatment. The effective date of this revision is based on process date.

Revision Number:2

Start Date of Comment Period:N/A Start Date of Notice Period:08/01/2009 Revised Effective Date: 07/16/2009

LCR A2009-066

July 2009 Bulletin

Explanation of Revision: Revision to the “CPT/HCPCS Codes” section to replace HCPCS code J3490 with code C9399 for billing synvisc-one. The effective date of this revision is based on date of service.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:04/01/2009 Revised Effective Date: 05/15/2009

LCR A2009-045

April 2009 Bulletin

Explanation of Revision: “Limitations” section revised to clarify that the course of treatment for viscosupplementation is not limited to two courses. Added J3490 (Hyaluronan or derivative, synvisc-one, for intra-articular injection, one dose. This revision is effective for claims processed on or after 05/15/2009 for dates of service on or after 02/26/2009.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/16/2009

LCR A2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO). For Florida (00090) this LCD (L29005) replaces LCD L1600 as the policy in notice. This document (L29005) is effective on 02/16/2009.

11/15/2009 - CPT/HCPCS code J7322 was deleted from group 1

8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 22 was changed 8/1/2010 - The description for Bill Type Code 23 was changed 8/1/2010 - The description for Bill Type Code 75 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0360 was changed 8/1/2010 - The description for Revenue code 0636 was changed

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

20610 descriptor was changed in Group 1

Reason for Change Typographical Correction