CurrentEmblemHealthPolicy MG.MM.PH.28

Medical Policy: Hyaluronate Injections for Osteoarthritis of the Knee

Defines medical necessity, dosing/quantity limits, preferred agents, step therapy and renewal criteria for intra-articular hyaluronate injections for osteoarthritis of the knee for EmblemHealth commercial (non-Medicaid) members; Medicare members referred to separate LCD/NCD criteria.

Policy Summary

PayerEmblemHealth

PolicyMedical Policy: Hyaluronate Injections for Osteoarthritis of the Knee

Policy CodePolicy MG.MM.PH.28

Change TypeClarified; Removed language

Effective DateJun 17, 2024

Next Review Date

Key ActionTreating physician must submit clinical evidence that member meets criteria, including symptomatic OA diagnosis, failed >=3 months of conservative therapy or intolerance, failed steroid injection, no contraindications, and documentation of failed trials of Gel-One AND Synvisc/Synvisc-One prior to other listed products.

SourceLink

POLICY UPDATE CHANGES

Added statement: For Medicare members Hyaluronate Injections please refer to our separate LCD/NCD Medicare criteria.

Removed Medicare Pharmacy coverage and language from policy effective 1/1/2024.

12 monthsAuthorization length

2Preferred agents listed (Gel-One, Synvisc/Synvisc-One)

RequiredStep therapy requirement

Multiple

Coverage Summary

Payer: EmblemHealth. Policy title: Hyaluronate Injections for Osteoarthritis of the Knee (Policy number: MG.MM.PH.28; Last review/effective date: 2024-06-17). Overview: Hyaluronan (hyaluronate) is a naturally occurring component of synovial fluid and intra-articular HA injections are proposed to restore synovial viscoelasticity in osteoarthritis (OA). This policy defines medical necessity, dosing/quantity limits, preferred agents, step therapy, and renewal criteria for intra-articular hyaluronate injections for EmblemHealth commercial (non‑Medicaid) members. Medicare members are referred to separate LCD/NCD Medicare criteria.

Key thresholds and authorization

Conservative therapy duration>= 3 months

Authorization length12 months

Step therapyFailed Gel-One AND Synvisc/Synvisc-One prior to other products

Medical Necessity Criteria

Coding

Applicable CPT/Procedure codesCPT

20610	Arthrocentesis, aspiration and/or injection, major joint or bursa (eg, shoulder, knee, subacromial bursa); without ultrasound guidance
20611	Arthrocentesis, aspiration and/or injection, major joint or bursa (eg, shoulder, hip, knee, subacromial bursa); with ultrasound guidance, with permanent recording and reporting

Applicable J-codes (Hyaluronan products)HCPCSCovered

J7318	Hyaluronan or derivative, Durolane, for intra-articular injection, per dose
J7320	Hyaluronan or derivative, Genvisc 850, for intra-articular injection, 1 mg
J7321	Hyaluronan or derivative, Hyalgan or 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

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Applicable NDCsNDCCovered

89130-2020-01	Durolane 60mg/3ml Prefilled Syringe
50653-0006-01	Genvisc 850 10mg/mL Solution
50016-0957-21	Visco-3 10mg/mL Solution Prefilled Syringe
89130-4444-01	Supartz Fx 10mg/mL Solution
89122-0724-12	Hyalgan 10mg/mL Solution
89122-0724-20	Hyalgan 10mg/mL Solution
89122-0496-63	Hymovis 24mg/3mL Solution Prefilled Syringe
55566-4100-01	Euflexxa 20mg/2mL Solution
55566-4100-00	Euflexxa 20mg/2mL Solution
59676-0360-01	Orthovisc 30mg/2mL Solution

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Applicable ICD-10 diagnosesICD-10Covered

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
M17.4	Other bilateral secondary osteoarthritis of knee
M17.5	Other unilateral secondary osteoarthritis of knee
M17.9	Osteoarthritis of knee, unspecified

Provider Actions

Prior Authorization

Clinical documentation for authorization

The treating physician must submit clinical evidence that the member meets all authorization criteria: documented symptomatic osteoarthritis of the knee; trial and failure of conservative therapy for at least 3 months or documented intolerance to conservative therapy; inadequate response to intra-articular corticosteroid injection; absence of contraindications to injections (for example active joint infection or bleeding disorder); and documentation of failed trials of Gel-One AND Synvisc or Synvisc-One prior to other listed hyaluronate products.

Billing Rule

Length of authorization

Coverage will be provided for 12 months and may be renewed when renewal criteria are met.

Background and Evidence

Background: Hyaluronan (HA) (also called hyaluronate or hyaluronic acid) is a naturally occurring macromolecule and major component of synovial fluid that contributes to its viscoelastic properties. In OA, HA chain length and concentration in synovial fluid are reduced, and intra-articular HA injections have been proposed to restore normal synovial fluid viscoelasticity (viscosupplementation). EmblemHealth based its criteria on published clinical literature, evidence-based guidelines and technology assessments, including the American Academy of Orthopaedic Surgeons (AAOS 2013), American College of Rheumatology (ACR 2012), Cochrane reviews (2015), and cited technology assessments and FDA device regulatory information.

Definitions:

Hyaluronan (HA): Also known as hyaluronate or hyaluronic acid; a naturally occurring macromolecule that is a major component of synovial fluid and is thought to contribute to its viscoelastic properties. Chemical cross-linking increases molecular weight; cross-linked HA are referred to as hylans.

Medicare Determinations

Medicare determinations: For Medicare members, please refer to separate LCD/NCD Medicare criteria (Separate LCD/NCD criteria apply). Revision note: Revision dated 6/17/2024 added the statement directing Medicare members to separate LCD/NCD Medicare criteria; prior revision (11/10/2023) removed Medicare pharmacy coverage and language effective 1/1/2024.

Revision History

2024-06-17revisionLatest

Added statement: For Medicare members Hyaluronate Injections please refer to our separate LCD/NCD Medicare criteria.

2023-11-10revision

Removed Medicare Pharmacy coverage and language from policy effective 1/1/2024.