LCD : Viscosupplementation Therapy (L23488)

LCD for Viscosupplementation Therapy (L23488)

Contractor Information

Contractor Name

BlueCross BlueShield of Tennessee (Riverbend Government Benefits Administrator)

Contractor Number

00390

Contractor Type

LCD Information

LCD ID Number

L23488

LCD Title

Viscosupplementation Therapy

Contractor's Determination Number

L23488

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2007 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 National Coverage Policy

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1862(a)(7) excludes routine physical examination.

Section 1861(t) of Title XVIII of the Social Security Act defines coverage of drugs and biologicals.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Publications:

CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 8:
50.5 Drugs and Biologicals [Coverage of SNF services]
70 Medical and Other Health Services Furnished to SNF Patients

CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 12:
40.10 Drugs and Biologicals [Coverage of Comprehensive Outpatient Rehabilitation Facility services]

CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15:
50-50.4.3 Drugs and Biologicals

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 4:
230 Billing for Drugs and Biologicals [OPPS]

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 25:
60 General Instructions for Completion of Form CMS-1450 for Billing

CMS Program Memorandum, Transmittal No. AB-02-082, Change Request #2230, June 11, 2002, describes coding changes for sodium hyaluronate.

CMS Program Memorandum, Transmittal No., 749, Change Request #4131, November 8, 2005, describes the non-implementation of the single a single new code for sodium hyaluronan products with instruction to use the same codes that were valid in 2005.

Primary Geographic Jurisdiction

New Jersey
Tennessee

Secondary Geographic Jurisdiction

Alaska
Alabama
Arkansas
Arizona
California
Colorado
Connecticut
Florida
Georgia
Hawaii
Iowa
Idaho
Illinois
Indiana
Kansas
Kentucky
Louisiana
Massachusetts
Maryland
Maine
Michigan
Minnesota
Missouri
Mississippi
North Carolina
North Dakota
Nebraska
New Jersey
New Mexico
Nevada
New York
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
Tennessee
Texas
Utah
Virginia
Vermont
Washington
Wisconsin
West Virginia
Wyoming

Oversight Region

Region IV

Original Determination Effective Date

For services performed on or after 09/30/2006

Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/29/2008

Revision Ending Date

Indications and Limitations of Coverage and/or Medical Necessity

This policy currently addresses all items covered by the generic definition of “viscosupplementation.” At the time of publication that includes Hyalgan, Synvisc, Supartz and Orthovisc.

The synovial fluid’s capacity to lubricate and absorb shock is typically reduced in joints affected by osteoarthritis. These changes are associated with a reduction in the concentration and size of hyaluronic acid molecules that are naturally present in synovial fluid; inflammation may be responsible for breaking down the lubricating hyaluronic acid (HA). Viscosupplementation is the process of injecting hyaluronate or its derivatives into the joint to treat pain associated with osteoarthritis of the knee. Clinical studies have demonstrated that injection of these agents into the joint space of osteoarthritic knees is followed by significant reduction in pain and improvement in functional capacity in a majority of patients who have failed to respond adequately to conservative therapy and simple analgesics.

Various polymers hyaluronic acid have been approved and marketed as implanted prosthetic devices. Clinical studies have demonstrated that injection of these agents into the joint space of osteoarthritic knees is sometimes marginally more effective than placebo procedures in reduction of pain and improvement in functional capacity in some patients. These marginal beneficial results are more pronounced with the larger molecular weight compound hylan G-F-20. There are no data indicating that these agents reverse or retard the osteoarthritic process in the injected joints. There is no long-term outcome data on the use of these devices for their FDA approved use. The long-term effect of repeated injections of the devices in the knee joint is unknown at this time.

The FDA has approved several HA products for intra-articular injection. Their FDA approval dates, molecular weights, individual vial contents, injection frequencies and total injection numbers differ; these details are available through their respective package inserts. Doses and injection frequencies of specific substances are approved ONLY in accordance with the FDA approved dosing guidelines (package insert) for that substance.

Indications

Viscosupplementation will be considered medically necessary when ALL of the following criteria have been met:
1. The patient is symptomatic with interference in functional activity (e.g., ambulation, prolonged standing, ability to sleep) because of the knee involvement.
2. There is a clinical diagnosis of osteoarthritis of the knee which is supported by radiological evidence and, where necessary, by laboratory tests to rule out other conditions.
a. knee pain associated with radiographic evidence of osteophytes in the knee joint, sclerosis in bone adjacent to knee or joint space narrowing;
b. morning stiffness of less than 30 minutes in duration or crepitus on motion of the knee.
3. The patient does not have end-stage degenerative joint disease. Cartilage must be present as demonstrated by x-ray.
4. There is explicit documentation that at least three months of conservative therapy have been tried, including pharmacologic therapy (e.g., aspirin or NSAIDs), exercise, and physical therapy, and the patient has failed to respond satisfactorily.
5. Surgical knee replacement is not a planned treatment option at the time the intra-articular viscosupplementation is administered. (The use of injections in an attempt to avoid knee replacement is reasonable; the use of injections in a patient for whom knee replacement is anticipated within the next year or two is not medically necessary.)
6. The pain and local joint symptoms cannot be attributed to other forms of joint disease, i.e. to other diagnoses or conditions.
7. The product is approved by the FDA for intra-articular injection.
8. If the first series of HA injections produce relief, then a second series may be reasonable if symptoms return. This one-time, repeat series of injections will be considered medically necessary only when:
a. At least six months has elapsed since the end of the prior series of injections, AND
b. The patient demonstrated clinical improvement with the initial series, as evidenced by significant improvement in pain and functional capacity objectively documented in the record AND/OR a significant reduction in the dose of NSAIDs taken or a reduction in the number of intra-articular steroid injections to the knees during the six month period following injection, again objectively documented in the medical record.
Limitations of Coverage:

Viscosupplementation is not covered when:
1. Diagnoses other than OA are being treated with the injection.
2. Joints other than the knee are being treated.
3. Viscosupplementation is being used as an initial treatment modality.
4. The provider fails to explicitly document the failure of conservative measures.
5. The dose of an injection exceeds the prescribed limits.
6. The number of injections in a series exceeds the prescribed limits.
7. The second series is started prior to six months following the completion of the first series.
8. HA is not approved for chronic use; therefore injections after the second series will not be considered to be medically necessary. For the purposes of determining chronic use, the use of ANY of these agents will be considered to be equivalent; the total number of series for all agents therefore may not exceed two.
9. Topical application of hyaluronate is not covered.

Coverage Topic

Outpatient Hospital Services
Prescription Drugs

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 (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00)
22x	SNF-inpatient or home health visits (Part B only)
74x	Clinic-ORF only (eff 4/97); ORF and CMHC (10/91 - 3/97)
85x	Special facility or ASC surgery-rural primary care hospital (eff 10/94)

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.

0636	Drugs requiring specific identification-detailed coding (eff 3/92)
0761	Treatment or observation room-treatment room (eff 9/93)

CPT/HCPCS Codes

Revenue Code – 636

The following HCPCS codes are effective for services performed on or after January 1, 2007 through December 31, 2007
Q4083, Q4084, Q4085, and Q4086

The following J-codes are effective January 1, 2008

J3490	UNCLASSIFIED DRUGS
J7321	HYALURONAN OR DERIVATIVE, HYALGAN OR SUPARTZ, FOR INTRA-ARTICULAR INJECTION, PER DOSE
J7322	HYALURONAN OR DERIVATIVE, SYNVISC, 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

Revenue Code – 761
Note: The following CPT code may be used for services other than viscosupplementation. The use for other purposes is not limited by this policy.

20610

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

ICD-9 Codes that Support Medical Necessity

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

ICD-9 Codes that DO NOT Support Medical Necessity

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

Diagnoses that DO NOT Support Medical Necessity

All diagnosis codes NOT listed in the section titled "ICD-9 Codes that Support Medical Necessity".

General Information

Documentation Requirements

1. Documentation defining the diagnosis of the patient, indicating the reason for which the service was performed, and supporting the medical necessity of the service must be submitted with each claim in the form of ICD-9-CM codes coded to the highest specificity. Claims submitted without such evidence will be denied as being not medically necessary.
2. The patient’s medical record should indicate the signs/symptoms supporting the diagnosis and functional impairment and prior clinical history. This should include such items as the severity of the osteoarthritis; presence of effusions and the size of the effusions; and the height and weight of the patient. The dosage of specific drugs given should also be documented. This information may be found in a recent history and physical, office notes, progress notes and/or a procedure note.
3. An X-ray report of the knee supporting the diagnosis of osteoarthritis of the knee joint must be available in the event of a review.
4. Medical records should reflect failure of conservative treatment such as physical therapy, weight loss (where appropriate), and prior failure of simple non-narcotic analgesics, including acetaminophen. Medication failure includes the lack of pain relief with mild analgesics, and/or an inability to take or respond to NSAIDS.
5. Medical documentation must be available in the patient’s chart to assure that this device is used within the FDA approved indications. Documentation should support that the patient does not have severe osteoarthritis.
6. The physician should also indicate which knee is being injected or if both knees are being injected in the documentation.
7. When billing for a repeat series of injections (in cases with demonstrated and proven improvement from the first series of injections), the record must indicate the last evaluation of the patient’s response to the prior series of injections on that knee. The response to the first series of injections must be meticulously documented using any type of a quantification method. Visual analog scale, joint mobility, reduction in effusion, patient-response-based questionnaires are all permissible. If the patient responds, reduced use of oral analgesics would be expected and should be documented in the medical records.
8. All documentation must be available to Medicare upon request, however all documentation does NOT have to reside in the facility record. Physician office records may be produced by the facility to support the medical necessity of the injection.

Drug Wastage Documentation Requirements

Any amount wasted must be clearly documented in the medical record with:

- Date and time
- Amount of medication wasted
- The reason for the wastage

Appendices

Utilization Guidelines

Drug Wastage

Medicare will cover the amount of the drug that is reasonable and necessary for the patient’s condition. If a physician must discard the remainder of a vial after administering a portion to a Medicare patient, the Medicare program may cover a small, but reasonable amount of discarded drug along with the amount administered. Medicare expects this wastage to be minimal. The provider should make an effort to schedule patients in such a way as to minimize any waste and use the drug most efficiently. Documentation requirements are given below. Coding and billing instructions can be referenced in the related article.

Sources of Information and Basis for Decision

1. LCDs from BCBS Kansas, AdminaStar, Arkansas, Empire, First Coast, Trailblazer and TriSpan
2. FDA approved package labeling.
3. Lo GH, LaValley M, McAlindon T, Felson DT, 2003. "Intraarticular Hyaluronic Acid in Treatment of Knee Osteoarthritis" JAMA 290(23): pp 3115-3121.

4. Brandt KD, Block JA, et al, 2001. "Efficacy and Safety of Intraarticular Sodium Hyaluronate in Knee Osteoarthritis" Clinical Orthopaedics and Related Research. 385 (4): pp 130-143.

5. Hochberg, M.C., et. al. 1996. "Guidelines for the Medical Management of Osteoarthritis." Arthritis Rheumatology Vol. 38 (11): pp. 1541-1548.

6. Adams, M.E., et. al. 1995. "The Role of Viscosupplementation With Hylan G-F-20 (Synvisc) in the Treatment of Osteoarthritis of the Knee." Osteoarthritis and Cartilage Vol. 3 pp. 213-226.

7. The Medical Letter, Inc., et. al., 1998. "The Medical Letter on Drugs and Therapeutics." Hyaluronan Injections for Osteoarthritis of the Knee Vol. 40 (Issue 1030) pp. 69-70.

8. Blue Cross Blue Shield Technology Evaluation Center, "Special Report: Intra-Articular Hyaluronan for Osteoarthritis of the Knee". Vol 19, No. 17 February 2005.

9. Bellamy N, Campbell J, Robinson V, et al. "Viscosupplementation for the Treatment of Osteoarthritis of the Knee". Cochrane Database Syst Rev (2):CD005321, 2005.

10. American Academy of Orthopaedic Surgeons®; (January 2003). Improving musculoskeletal care in america, osteoarthritis of the knee: treatment options; Available at: http://www.3.aaos.org/research/imca/OAkneeContents/OA_knee_m5.htm. Accessed December 12, 2005.

11. Aggarwal A., Sempowski I.P.Hyaluronic acid injections for knee osteoarthritis. Can Fam Phy, Feb 2004 vol. 50. Available at: http://www.cfp.ca./cfp/2004/Feb/vol50-feb-cme-2.asp. Accessed December 12, 2005.

12. Dubey, V., Glazier, R.H.Critical appraisal intra-articular hyaluronic acid injections. Can Fam Phy, 2003 Apr. vol. 49. Available at: http://www.cfp.ca./cfp/2003/Apr/vol49-apr-critical-1.asp. Accessed December 12, 2005.

13. Petrella, R.J. Hyaluronic Acid Research. Am J Phys Med Rehabil. 2005 Apr; 84(4):278-83. Available at:
http://www.Raysahelian.com/hyaluronic-acid.html. Accessed December 12, 2005.

14. Wang, Chen Ti, et.al. Therapeutic effects of hyaluronic acid on osteoarthritis of the knee. J Bone Joint Surg Am vol. 86-A, number 3, March 2004.

15. American Medical Association’s Technologica. February/March 2000, p 9.

16. Lussier, A., et al. "Viscosupplementation with hylan for the treatment of osteoarthritis: Findings from clinical practice in Canada." The Journal of Rheumatology. 1996: 23:9

17. Corrado, E.M., et al. "The effects of intra-articular administration of hyaluronic acid on osteoarthritis of the knee: A clinical study with immunological and biochemical evaluations." European Journal of Rheumatology and Inflammation. 1995: Vol 15 Issue 1.

18. Mensitieri, M., et al. "Viscoelastic evaluation of different knee osteoarthritis therapies." Journal of Materials Science: Materials in Medicine. 6 (1995): pp. 130-137.

19. Scale, D., et al. "Viscosupplementation of osteoarthritic knees with hylan: a treatment of schedule study." Current Therapeutic Research. March 1994: Vol. 5, No. 3, pp.220-232.

20. Dougados, M., et al. "High molecular weight sodium hyaluronate (hyalectin) in osteoarthritis of the knee: a 1year placebo-controlled trial." Osteoarthritis and Cartilage 1993: Vol. 1 pp. 97-103.

21. Balazs, E.A., Denlinger, J.L. " Viscosupplementation: A new concept in the treatment of osteoathritis." The Journal of Rheumatology. 1993: Vol. 20.

22. Peyron, J.G. " Intra-articular hyaluronan injections in the treatment of osteoarthritis: state of the art review." The Journal of Rheumatology. 1993: Vol. 20.

23. Adams, M.E. "An analysis of clinical studies of the use of crosslinked hyaluronan, hylan, in the treatment of osteoarthritis." The Journal of Rheumatology. 1993: Vol. 20.

24. Pelletier, J.P., Martel-Pelletier, J. " The pathophysiology of osteoarthritis and the implication of the use of hyaluronan and hylan as therapeutic agents in viscosupplementation." The Journal of Rheumatology. 1993: Vol. 20.

25. Hochberg MC, Altman RD, Brandt KD, et al. "Guidelines for the medical management of osteoarthritis." Arthritis/Rheum. 1995: 38(11): 1541-1546.

Advisory Committee Meeting Notes

This policy was submitted to the FIAC electronically and was clarified in response to comments.

Start Date of Comment Period

06/30/2006

End Date of Comment Period

08/15/2006

Start Date of Notice Period

08/16/2006

Revision History Number

Revision History Explanation

R1 Released for notice.

11/18/2006 - CPT/HCPCS code J7317 was deleted from group 1
11/18/2006 - CPT/HCPCS code J7320 was deleted from group 1

01/10/2007 - Code correction made to 2007 HCPCS.

10/30/2007 - Reviewed with no changes

Per HCPCS January 1, 2008 update
01/29/2008 - HCPCS code J7321 was added to group 1
01/29/2008 - HCPCS code J7322 was added to group 1
01/29/2008 - HCPCS code J7323 was added to group 1
01/29/2008 - HCPCS code J7324 was added to group 1
01/29/2008 - Q4083, Q4084, Q4085, Q4086 are deleted and no longer effective

Reason for Change

HCPCS Addition/Deletion

Last Reviewed On Date

01/29/2008

Related Documents

This LCD has no Related Documents.

LCD Attachments

Comment and Response - Comment and Response (6,867 bytes)

Other Versions

Updated on 10/30/2007 with effective dates 01/10/2007 - 01/28/2008

Updated on 01/10/2007 with effective dates 01/10/2007 - N/A

Updated on 01/09/2007 with effective dates 09/30/2006 - N/A