Notification

Hyaluronan Acid Therapies for Osteoarthritis of the Knee


Notification Issue Date: 10/03/2019

This version of the policy will become effective 01/01/2020.

This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling, Novitas Solutions, Inc. Local Coverage Article (LCA).A55036, andNovitas Solutions, Inc. Local Coverage Determination (LCD).L35427recommendations This policy was updated to communicate The Company’s preferred and non-preferred agents. New step therapy for injection of intra-articular corticosteroids was added per Novitas.
The following HCPCS codes have been added to this policy:

J7331 Hyaluronan or derivative, synojoynt, for intra-articular injection, 1 mg
J7332 Hyaluronan or derivative, triluron, for intra-articular injection, 1 mg



Medicare Advantage Policy

Title:Hyaluronan Acid Therapies for Osteoarthritis of the Knee
Policy #:MA11.023i

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

INITIAL SERIES
Single or bilateral injections of hyaluronan acid are considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual 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 individual 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
    • Non-narcotic analgesics (e.g., acetaminophen) or nonsteroidal anti-inflammatory drugs (NSAIDS), if not contraindicated.
  • The individual has failed to respond to aspiration of the knee when effusion is present and intra-articular corticosteroid injection therapy when inflammation is a significant component of the individual’s symptoms and intra-articular corticosteroids are not contraindicated.

REPEAT SERIES
A repeat series of injections with hyaluronan acid is considered medically necessary and, therefore, covered for those individuals who have responded to the first series and meet the following requirements:
  • Symptoms have recurred AND,
  • At least six months have elapsed since the prior series of injections AND,
  • There was significant improvement in pain and functional capacity achieved with the prior series of injections using a standardized assessment tool OR,
  • There is significant reduction in the doses of NSAID medications taken or reduction in the number of intra-articular steroid injections to the knees during the six-month period following the injection(s).

COMPANY-DESIGNATED PREFERRED PRODUCTS

Although there are many brands of viscosupplement on the market for the treatment of osteoarthritis of the knee, there is no reliable evidence of the superiority of any one brand of viscosupplement compared to other brands. The Company has designated Monovisc®, Orthovisc®, Synvisc®, and Synvisc-One® as its preferred products.

These products are less costly and at least as likely to produce equivalent therapeutic results as the non-preferred products, which include, but are not limited to: Durolane®, Euflexxa®, Gel-One®, Hyalgan®, Hymovis®, Gelsyn-3™ (formerly Gel-Syn™), GenVisc 850®, Triluron™, TriVisc™, Supartz®, Synojoynt™, and Visco-3™.

For individuals who meet the above medical necessity criteria, use of the Company-designated preferred products, Monovisc®, Orthovisc® and a Synvisc® Product (either Synvisc® or Synvisc-One®), is considered medically necessary and, therefore, covered.

NON-PREFERRED PRODUCTS

For individuals who meet the above medical necessity criteria, use of non-preferred products (which include, but are not limited to: Durolane®, Euflexxa®, Gel-One®, Hyalgan®, Hymovis®, Gelsyn-3™ (formerly Gel-Syn™), GenVisc 850®, Triluron™, TriVisc™, Supartz®, Synojoynt™, and Visco-3™) is considered medically necessary and, therefore, covered in at least one the following instances*:
  • The individual has a documented contraindication, or documented non-response, to all preferred products (Monovisc®, Orthovisc® and a Synvisc® product [either Synvisc® or Synvisc-One®]).
  • The individual is currently receiving or has previously received a non-preferred product for intra-articular hyaluronan injection of the knee.

*Requests for the use of non-preferred products that do not meet either of these conditions are considered not medically necessary and, therefore, not covered.

LIMITATIONS OF ADMINISTRATION
A series is defined as a set of injections for each joint and each treatment. The frequency of injection(s) applies to the initial series and repeat series as follows:

A course of treatment for a single knee is composed of one of the following:
  • One intra-articular injection of Synvisc-One®, Gel-One®, Monovisc®, or Durolane®
  • Two intra-articular injections of Hymovis®, each injection administered one week apart
  • Three intra-articular injections of Euflexxa®, Gelsyn-3 [formerly Gel-Syn™], Synvisc®, Visco-3™, or TriVisc, Synojoynt™, Triluron each injection administered one week apart
  • Three to four intra-articular injections of Orthovisc®, each injection administered one week apart
  • Five intra-articular injections of Hyalgan®, GenVisc 850®, or Supartz®, each injection administered one week apart

NOT MEDICALLY NECESSARY

When the above criteria for intra-articular injection of hyaluronan acid into the knee are not met, the service is considered not medically necessary and, therefore, not covered.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

For Medicare Advantage members, certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when intra-articular hyaluronan in the treatment of osteoarthritis of the knee is covered under a member's medical benefit (Part B benefit). It does not address instances when intra-articular hyaluronan in the treatment of osteoarthritis of the knee is covered under a member’s pharmacy benefit (Part D benefit).

ADMINISTRATION

The FDA has approved the following preparations of intra-articular hyaluronan in the treatment of osteoarthritis of the knee:
  • Synvisc® (hylan G-F 20)
  • Synvisc-One® (hylan G-F 20)
  • Orthovisc® (high-molecular-weight hyaluronan)
  • Hyalgan® (sodium hyaluronate)
  • Supartz®(sodium hyaluronate)
  • Euflexxa® (1% sodium hyaluronate)
  • Gel-One® (hyaluronic acid)
  • Monovisc® (high molecular-weight hyaluronan)
  • Gelsyn-3[formerly Gel-Syn™] (sodium hyaluronate)
  • GenVisc 850® (sodium hyaluronate)
  • Hymovis® (high-molecular-weight viscoelastic hyaluronan)
  • Visco-3™ (sodium hyaluronate)
  • Durolane® (hyaluronic acid)
  • TriVisc (sodium hyaluronate)
  • Triluron™ (sodium hyaluronate)
  • Synojoynt™ (sodium hyaluronate)

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, hyaluronan acid is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as experimental/investigational or not medically necessary are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA has approved the following preparations of intra-articular hyaluronan in the treatment of osteoarthritis of the knee: Synvisc®, Synvisc-One®, Orthovisc®, Hyalgan®, Hymovis®, Supartz®, Euflexxa®, Monovisc®, Gelsyn-3 (formerly Gel-Syn™), GenVisc 850®, Gel-One®, Visco-3™, Durolane®, Triluron™, Synojoynt™ and TriVisc3 .

Description

Various polymers hyaluronic acid have been approved and marketed as implanted prosthetic devices. Clinical studies of sodium hyaluronate and hylan G-F-20 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 individuals. These marginal beneficial results are more pronounced with the larger molecular weight compound hylan G-F20. There are no data indicating that these agents reverse or retard the osteoarthritic process in the injected joints. The long-term effects of repeated injections are unknown.

Synthetic and naturally occurring hyaluronic-acid derivatives are administered intra-articularly. The mechanism(s) of action are not known. There is some evidence for an anti-inflammatory effect, a short-term lubricant effect, an analgesic effect by directly buffering the synovial nerve endings, and a stimulating effect on synovial lining cells leading to the production of normal hyaluronic acid. They have become a treatment option for individuals with osteoarthritis who have failed to respond, or had a contraindication, to conservative therapy such as analgesics and NSAIDs.

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References

Agency for Healthcare Research and Quality (AHRQ). Technology Assessment Report. Systematic Review for Effectiveness of Hyaluronic Acid in the Treatment of Severe Degenerative Joint Disease (DJD) of the Knee. 07/23/2015. Available at: https://www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=101&bc=AAAQAAAAAAAAAA%3d%3d&. Accessed August 08, 2019.

Novitas Solutions, Inc. Local Coverage Article (LCA).A55036: Hyaluronan Acid Therapies for Osteoarthritis of the Knee. [Novitas Solutions, Inc. Web site]. Original Effective date: 04/01/2016. Revisions effective date: 05/20/ 2019. Available at:
https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=55036&ver=43&Keyword=Hyaluronan+Acid+Therapies&KeywordSearchType=Or&Date=&PolicyType=Both&ArticleType=SAD%7cEd&Cntrctr=323*1&KeyWordLookUp=Doc&SearchType=Advanced&CoverageSelection=Both&kq=true&bc=IAAAACAAAAAA&. Accessed August 08, 2019.

Novitas Solutions, Inc. Local Coverage Determination (LCD).L35427: Hyaluronan Acid Therapies for Osteoarthritis of the Knee. [Novitas Solutions, Inc. Web site]. Original Effective date: 10/01/2015. Revision effective date: 05/20/ 2019. Available at:
https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35427&ver=68&Date=&DocID=L35427&bc=iAAAABAAAAAA&
Accessed August 08, 2019.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

M17.0 Bilateral primary osteoarthritis of knee

M17.10 Unilateral primary osteoarthritis, unspecified knee

M17.11 Unilateral primary osteoarthritis, right knee

M17.12 Unilateral primary osteoarthritis, left knee

M17.2 Bilateral post-traumatic osteoarthritis of knee

M17.30 Unilateral post-traumatic osteoarthritis, unspecified knee

M17.31 Unilateral post-traumatic osteoarthritis, right knee

M17.32 Unilateral post-traumatic osteoarthritis, left knee

M17.4 Other bilateral secondary osteoarthritis of knee

M17.5 Other unilateral secondary osteoarthritis of knee

M17.9 Osteoarthritis of knee, unspecified



HCPCS Level II Code Number(s)


J7318 Hyaluronan or derivative, durolane, for intra-articular injection, 1 mg

J7320 Hyaluronan or derivative, GenVisc 850, for intra-articular injection, 1 mg

J7321 Hyaluronan or derivative, Hyalgan, Supartz or Visco-3, for intra-articular injection, per dose

J7322 Hyaluronan or derivative, Hymovis, for intra-articular injection, 1 mg

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

J7327 Hyaluronan or derivative, Monovisc, for intra-articular injection, per dose

J7328 Hyaluronan or derivative, GELSYN-3, for intra-articular injection, 0.1 mg

J7329 Hyaluronan or derivative, trivisc, for intra-articular injection, 1 mg

J7331 Hyaluronan or derivative, synojoynt, for intra-articular injection, 1 mg

J7332 Hyaluronan or derivative, triluron, for intra-articular injection, 1 mg



Revenue Code Number(s)

N/A

Coding and Billing Requirements

BILLING REQUIREMENTS

When the individual presents for an injection of a hyaluronan agent only, it is not appropriate for the provider to report an evaluation and management (E/M) service.

For Synvisc® and Synvisc-One®, providers must use the Healthcare Common Procedure Coding System (HCPCS) code J7325 and follow the below requirements:
  • Synvisc® is administered by intra-articular injection once a week (one week apart) for a total of three injections. Providers must bill 16 units of HCPCS code J7325 for each injection of Synvisc®.
  • Synvisc-One® is administered as one single intra-articular injection. Providers must bill 48 units of HCPCS code J7325 for the single injection of Synvisc-One®.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

Cross References




Policy History

Revisions to MA11.023i
01/01/2020This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling, Novitas Solutions, Inc. Local Coverage Article (LCA).A55036, andNovitas Solutions, Inc. Local Coverage Determination (LCD).L35427recommendations This policy was updated to communicate The Company’s preferred and non-preferred agents. New step therapy for injection of intra-articular corticosteroids was added per Novitas.
The following HCPCS codes have been added to this policy:
    J7331 Hyaluronan or derivative, synojoynt, for intra-articular injection, 1 mg
    J7332 Hyaluronan or derivative, triluron, for intra-articular injection, 1 mg

Revisions to MA11.023h
01/01/2019This policy has been identified for the HCPCS code update, effective 01/01/2019.

The following HCPCS codes have been added to this policy:
J7318 Hyaluronan or derivative, durolane, for intra-articular injection, 1 mg
J7329 Hyaluronan or derivative, trivisc, for intra-articular injection, 1 mg

The following HCPCS codes have been removed from this policy:
C9465 Hyaluronan or derivative, Durolane, for intra-articular injection, per dose
J3490 Unclassified drugs

Revisions to MA11.023g
04/09/2018This policy has undergone a routine review and the medical necessity criteria have been revised to reflect The Company's position regarding coverage of Hyaluronan acid therapies for osteoarthritis of the knee, per US Food and Drug Administration labeling, Novitas Solutions (LCD) #L35427 and (LCA) #A55036.

The following HCPCS code was added for Durolane:
C9465 Hyaluronan or derivative, Durolane, for intra-articular injection, per dose

Revisions to MA11.023f
01/01/2018This policy has been identified for the HCPCS code update, effective 01/01/2018.

The following HCPCS code has been removed from this policy:
J3490 Unclassified drugs

The following HCPCS narrative has been revised in this policy:
J7321:

FROM: Hyaluronan or derivative, Hyalgan or Supartz, for intra-articular injection, per dose
TO: Hyaluronan or derivative, hyalgan, supartz or visco-3, for intra-articular injection, per dose

Revisions to MA11.023e
01/01/2018This policy has been identified for the HCPCS code update, effective 01/01/2017.

The following HCPCS codes have been added to this policy:
J7320 Hyaluronan or derivitive, genvisc 850, for intra-articular injection, 1 mg
J7322 Hyaluronan or derivative, hymovis, for intra-articular injection, 1 mg

The following HCPCS codes have been deleted from this policy:
C9471 Hyaluronan or derivative, Hymovis, for intra-articular injection, 1 mg
Q9980 Hyaluronan or derivative, for intra-articular injection, 1 mg

Revisions to MA11.023d
11/28/2016This policy has been updated to communicate the Company's coverage of Visco-3™.
The information about the frequency of injection(s) for the initial series and repeat series has been updated.

Revisions to MA11.023c
04/01/2016This policy has been identified for the HCPCS code update, effective 04/01/2016.

The following HCPCS codes have been added to this policy, as Medically Necessary:

THE FOLLOWING CODE IS USED TO REPRESENT HYMOVIS:
J3490: Unclassified drugs

Healthcare Common Procedure Coding System (HCPCS) C Series Codes can only be reported for outpatient facility services. Professional providers should not report HCPCS C Series Codes for professional services regardless of where those services are performed:
C9471 Hyaluronan or derivative, Hymovis, for intra-articular injection, 1 mg

Revisions to MA11.023b
01/01/2016This policy has been identified for the HCPCS code update, effective 01/01/2016.

The following HCPCS codes have been added to this policy, as Medically Necessary:
    J7328 Hyaluronan or derivative, gel-syn, for intra-articular injection, 0.1 mg
    Q9980 Hyaluronan or derivative, genvisc 850, for intra-articular injection, 1 mg

ICD-9 Diagnosis codes have been removed from this policy, since ICD-10 Diagnosis codes are now active.

Revisions to MA11.023a
09/01/2015This policy has been updated to clarify The Company's position regarding coverage of Hyaluronan acid therapies for osteoarthritis of the knee, per Novatis Solutions (LCD) #L32237.

Revisions to MA11.023
01/01/2015This is a new policy.

12/03/2014: While the policy was in notification, this policy was identified for the HCPCS code update, effective 01/01/2015.
    The following CPT code has been added to this policy: 20611

    The following HCPCS narrative has been revised in this policy: 20610

    The following HCPCS code has been removed from this policy and is replaced by the following NOC code:
    DELETED: J3590
    REPLACED WITH: J7327






Version Effective Date: 01/01/2020
Version Issued Date: 12/31/2019
Version Reissued Date: N/A