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DESCRIPTIONHyaluronan (HA), also known as sodium hyaluronate or hyaluronic acid, is a naturally occurring macromolecule that is a major component of synovial fluid and is thought to contribute to its viscoelastic properties. Chemical crosslinking of hyaluronan increases its molecular weight; crosslinked hyaluronans are referred to as hylans. In osteoarthritis, the overall length of HA chains present in cartilage and the HA concentration in the synovial fluid are decreased. Intra-articular injection of HA (IA-HA) has been proposed as a means of restoring the normal viscoelasticity of the synovial fluid in patients with osteoarthritis. This treatment has been called viscosupplementation.
Currently, there is no curative therapy for osteoarthritis, and thus the overall goals of management are to reduce pain and prevent disability. In 1995, the American College of Rheumatology published guidelines for the treatment of osteoarthritis of the knee, which recommended acetaminophen as the first line of therapy followed by low-dose ibuprofen and then full-dose non-steroidal anti-inflammatory drugs (NSAIDS), if necessary. Several preparations of intra-articular hyaluronan have been approved by the U.S. Food and Drug Administration (FDA) as an alternative to NSAID therapy in the treatment of osteoarthritis of the knee: Synvisc® and Synvisc-One® (Genzyme); Gel-One® (Zimmer); Hyalgan® (Fidia); Supartz FX™ (Bioventus); OrthoVisc® (Anika); Euflexxa®, previously named Nuflexxa (Savient); Monovisc® (Anika Therapeutics); and Gel-Syn™ (Institut Biochimique SA). All products are manufactured from rooster combs except for Euflexxa, Orthovisc, Monovisc, Gel-Syn, and GenVisc 850, which are produced from bacterial fermentation. Also, Synvisc undergoes additional chemical crosslinking to create hylans with increased molecular weight (6000 kDa) compared with Hyalgan (500-730 kDa) and Supartz (620-1170 kDa). Monovisc is also cross-linked with a proprietary cross-linker. The differing molecular weights of the products lead to different half-lives; the half-life of Hyalgan or Supartz is estimated at 24 hours, while the half-life of Synvisc may range up to several days.
According to the manufacturer's prescribing information for Synvisc and Euflexxa, intra-articular hyaluronan is “indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e.g., acetaminophen.” The product inserts further indicate that Synvisc and Euflexxa should be injected intra-articularly into the knee joint once per week for a total of three injections over a two to three-week period. In contrast, 5 weekly injections are recommended for the Hyalgan and Supartz products, and 3-4 weekly injections are recommended for OrthoVisc. In February 2009, the FDA approved the use of single-dose hylan G-F 20 (Synvisc-One) for the treatment of osteoarthritis of the knee. In 2011, the FDA approved the use of the single-dose cross-linked hyaluronate Gel-One (also known as Gel-200) for the treatment of OA of the knee. In 2014, Monovisc was also approved as a single-dose treatment, while Gel-Syn was approved as a course of 3 weekly injections. In 2015, GenVisc 850 was approved as a course of 3 weekly injections.
In 2000, the FDA approved removal of a precautionary statement from the package inserts for Hyalgan and Synvisc that stated that the safety and efficacy of repeat courses have not been established.
The FDA has not approved intrarticular hyaluronan for joints other than the knee.
POLICYIntra-articular hyaluronan injections may be considered medically necessary for treatment of painful osteoarthritis of the knee in patients who have insufficient pain relief from conservative nonpharmacologic therapy and simple analgesics.
Repeated courses of intra-articular hyaluronan injections may be considered medically necessary under the following conditions:
The use of intra-articular hyaluronan injections into joints other than the knee is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY5/1998: Approved by Medical Policy Advisory Committee (MPAC)
8/2001: Reviewed by MPAC; Supartz added
1/29/2001: HCPCS code added
2/14/2002: Investigational definition added
3/12/2002: New 2002 codes added, J7315 deleted
5/1/2002: Type of Service and Place of Service deleted
8/2002: Reviewed by MPAC; no changes
3/13/2003: Code Reference section updated
8/29/2003: Arthrease and Orthovisc added
11/5/2003: Code Reference section reviewed, HCPCS J3490 deleted
3/31/2004: Arthrease (Savient Pharmaceutical) and Orthovisc (Anika Therapeutics) have received FDA approval
2/18/2005: Policy reviewed, Sources updated
9/21/2005: Description revised to be consistent with BCBSA policy # 2.01.31
12/13/2006: Policy reviewed, no changes
1/2/2007: Code Reference section updated per the 2007 CPT/HCPCS revisions
3/26/2007: Registered trademark symbols added
6/14/2007: Code Reference section updated per quarterly HCPCS and Category III revisions
12/19/2007: Code Reference section updated per the 2008 CPT/HCPCS revisions
1/15/2008: Policy description updated. POLICY section rewritten for clarity. Added repeated courses of intra-articular hyaluronan injections may be considered medically necessary if there was significant pain relief with the prior course, and at least six months have passed since the course to POLICY section. Osteoarthritis added to policy title.
3/27/2008: Reviewed and approved by MPAC
10/15/2009: Policy reviewed, no changes
12/15/2009: Coding Section revised for 2010 CPT4 and HCPCS revisions
12/30/2010: Policy description and statement unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section.
05/17/2011: Policy reviewed; no changes.
03/02/2012: Policy reviewed; no changes.
05/13/2013: Policy description updated to add information regarding the single-dose cross-linked hyaluronate Gel-One®. Code Reference section updated to remove deleted HCPCS code J7322 and to add HCPCS code J7326. Removed ICD-9 procedure code 81.92 from the Code Reference section.
12/31/2014: Code Reference section updated to revise the description of the following CPT code: 20610. Effective 1/1/15. Added the following new 2015 CPT code: 20611. Added the following new 2015 HCPCS code: J7327.
08/28/2015: Medical policy revised to add ICD-10 codes.
06/06/2016: Policy number L.2.01.422 added. Policy Guidelines updated to add medically necessary and investigative definitions.
10/19/2016: Policy description updated regarding products. Policy statements unchanged. Code Reference section updated to add HCPCS codes J7328 and Q9980.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.01.31
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.