CPT code J7231, J7323, J7324, J7325 - Hyaluronate Polymers


cpt code and description



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

J7326 Hyaluronan or derivative, gel-one, for intra-articular injection, per dose

HCPC’s code J7325 is defined as 1 mg

J7325 Hyaluronan or Derivative, Synvisc or Synvisc-One, For Intra-Articular Injection, 1mg  When this injection is administered either unilaterally or bilaterally the injections would be billed by placing J7325 in item 24 (FAO-09 electronically) and listing the total number of mg’s administered in the units field.

There are 2 different products that are billed using this code.

Synvisc® - (16mg/2ml) – injection is given once a week (i.e., at seven-day intervals) for a total of three injections.


Synvisc-One™- (48mg/6ml) - single dose injection


Various hyaluronic acid polymers 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 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. The long-term effects of repeated injections are unknown.

  • Medicare will cover the cost of the injection and the injected hyaluronate polymer for patients who meet the following clinical criteria:
    • Knee pain associated with radiographic evidence of osteophytes in the knee joint, sclerosis in bone adjacent to knee or joint space narrowing.
    • Morning stiffness of less than 30 minutes in duration or crepitus on motion of the knee.
  • The pain cannot be attributed to other forms of joint disease.
  • The prosthetic device is approved by the FDA for intra-articular injection.
  • Pain that interferes with functional activities (e.g., ambulation, prolonged standing, ability to sleep).
  • Lack of functional improvement following a trial of at least three months of conservative therapy, or the patient is unable to tolerate Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy because of adverse side effects.
  • Bilateral injections may be allowed if both knees meet the criteria


The frequency of injections is:

  • An initial series of three to five weekly injections per knee. Note: Synvisc-ONE is administered through a single intra-articular injection.
  • A repeat series of injections for patients who have responded to the first series may be given individual consideration by Medicare for coverage under the following circumstances:
    • The medical record objectively documents significant improvement in pain and functional capacity using a standardized assessment tool.
Or,
    • The medical record documents significant reduction in the doses of non-steroidal anti-inflammatory medications taken or reduction in the number of intra-articular steroid injections to the knees during the six-month period following the injection.
    • And,
    • At least six months have elapsed since the prior series of injections.


A series is defined as a set of injections for each joint and each treatment. The EJ modifier must be used with the HCPCS code for the drug administered to indicate subsequent injections of a series. The modifier is not to be used with the first injection of each series.

The appropriate records documenting the improvement must be maintained in the medical record and made available to Medicare upon request.

If the series of injections using sodium hyaluronate did not prove to be beneficial to the patient, it would not be reasonable to repeat the therapy again using any of these products. Thus, a repeat series of injections would not be covered.
Topical application is not covered.

Drug Wastage
Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient’s condition. If the physician has made good faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored and used the drug and made good faith efforts to minimize the unused portion of the drug in how it is supplied, then the program will cover the amount of drug discarded along with the amount administered. Documentation requirements are given below. 


Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:

  • Safe and effective.
  • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
  • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
    • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
    • Furnished in a setting appropriate to the patient’s medical needs and condition.
    • Ordered and furnished by qualified personnel.
    • One that meets, but does not exceed, the patient’s medical need.
    • At least as beneficial as an existing and available medically appropriate alternative.

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, 18X, 21X, 71X, 73X, 74X, 77X, 83X, 85X
Bill Type Note: Code 73X end-dated for Medicare use March 31, 2010; code 77X effective for dates of service on or after April 1, 2010.

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.


CPT/HCPCS Codes
Note:
Providers are reminded to refer to the long descriptors of the CPT codes in their CPT books. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of shortCPT descriptors in policies published on the Web.

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





Intra-articular Injections of Hyaluronan (INJ-033) Billing and Coding Guidelines Coding Guidelines

1. HCPCS code J7321, J7323, and J7324, J7326 are per dose codes. When the injections are administered bilaterally, list J7321, J7323, J7324 or J7326 in item 24 (FAO-09 electronically) with a 2 in the unit’s field.


2. HCPC’s code J7325 is defined as 1 mg J7325 Hyaluronan or Derivative, Synvisc or Synvisc-One, For Intra-Articular Injection, 1mg

When this injection is administered either unilaterally or bilaterally the injections would be billed by placing J7325 in item 24 (FAO-09 electronically) and listing the total number of mg’s administered in the units field.

There are 2 different products that are billed using this code. Synvisc® - (16mg/2ml) – injection is given once a week (i.e., at seven-day intervals) for a total of three injections. Synvisc-One™- (48mg/6ml) - single dose injection

3. The aspiration and/or injection procedure code may be billed in addition to the drug. Indicate which knee was injected by using the RT (right) or LT (left) modifier (FAO-10 electronically) on the injection procedure (CPT 20610). Place the CPT code 20610 in item 24D. If the drug was administered bilaterally, a -50 modifier should be used with 20610.

4. When this drug is administered in the hospital (inpatient or outpatient) setting, the drug/visco supplementation would not be covered by Part B. It would be covered under the Part A benefit.

5. Evaluation and management service:

a. An E&M service may be appropriate if the decision to start the series of injections is made after an evaluation during the same visit. Indicate this by using an E&M code with modifier -25.

b. After the first injection, during the visits for subsequent injections, an E&M service will not be covered unless there was a separately identifiable problem for which the E&M service was required and rendered.

6. When additional substances are concomitantly administered (e.g. cortisone, anesthetics) with viscosupplementation, only one injection service is allowed per knee.

7. If the drug is denied as not reasonable and necessary, the associated injection code is also not covered.

8. We suggest that the entire series of injections be billed on the same claim form. 


Coding Guidelines

1. HCPCS code J7321, J7323, and J7324 are per dose codes. When the injections are administered bilaterally, list J7321, J7323 or J7324 in item 24 (FAO-09 electronically) with a 2 in the unit’s field.

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

Medicare Recommendations for Knee Injection

Purpose: To establish uniform criteria for billing knee injections, viscosupplementation injections of the knee and
ultrasound guidance.

Applies To:  Procedure Codes 20610 Arthrocentesis, aspiration and/or injections; major joint or bursa 76942 Ultrasonic guidance for needle placement, imaging supervision and interpretation, and applicable HCPCS Codes; J7321 (Hyalgan or Supratz), J7323 (Euflexxa), J7324 (Orthovisc), J7325 (Synvisc or SynviscOne) and J7326 (Gel-One) Policy: Knee injections with corticosteroids may be performed as deemed medically necessary by the physician.

Knee injections for viscosupplementation will be performed at the physician’s discretion in accordance with medical necessity standards supporting osteoarthritis of the affected joint under the following conditions:

- There is radiological evidence to support the diagnosis of osteoarthritis; and

- There is adequate documentation that simple pharmacologic therapy (e.g. aspirin), or exercise and physical therapy have been tried and the patient failed to respond satisfactorily Additional repeat viscosupplementation treatments are considered medically necessary and can be   billed for patients being treated for osteoarthritis of the knee, who meet both of the following criteria:

- Significant improvement in knee pain and known improvement in functional capacity resulted from previous series of injections which has been documented in the record; and

- At least six (6) months have lapsed since the prior series of injections.

Ultrasound guidance for knee injections should not be a routine policy and can only be billed when at least one of the following medical necessity requirements has been met and thoroughly documented:

- History of severe trauma which would derange the normal architecture of the joint

- Erosive systemic arthritis (rheumatoid disease) or other systemic disease (lupus, gout, etc.).

 - Failure of the initial attempt of a knee joint injection

 - Size of the knee due to morbid obesity (BMI = 40) or other disease process

 - Aspiration of a Baker’s cyst



Billing points:

- If aspiration and injection performed in same session, bill only one unit 20610.

- Append appropriate site modifier to code 20610 (RT/LT) unilateral or modifier (50) bilateral.

- Drug codes must be reported on separate line for each site being injected with a modifier (RT or LT).

- Evaluation and management codes will not be routinely billed with joint injections. When a separately identifiable service has been provided and thoroughly documented, they may be billed with modifier 25



Private Payers

This step is recommended for privately insured patients. The patient should be specifically preauthorized for their SUPARTZ FX (sodium hyaluronate) 25mg injection series (HCPCS code J7321). The BioLinx reimbursement hotline is available for insurance verification and prior authorization support. If you choose not to use BioLinx, your staff will need to inquire whether the payer requires prior authorization and/or use of a specific Specialty Pharmacy. Payers may not volunteer Specialty Pharmacy requirements, so you must ask! When a payer requires that SUPARTZ FX be ordered through a Specialty Pharmacy, please contact that entity to obtain the product. If the payer states that no preauthorization is necessary, verify that sodium hyaluronate injections are a covered benefit under the patient’s plan.

Each private payer varies in administration of benefits, reimbursement and policy coverage. Some private payers may follow Medicare’s coverage policies, while others may have less restrictive criteria. Refer to specific payer guidelines and provider fee schedules for more information.


HMO, PPO, Individual Marketplace, Advantage, Elite

An initial course of viscosupplementation (J7325) is considered medically necessary for the treatment of pain due to osteoarthritis of the knee when ALL of the following criteria are met:

1. There is documentation of a diagnosis of osteoarthritis and there is no evidence of inflammatory arthritis (for example, rheumatoid arthritis).

2. There is documentation that the pain interferes with functional activities (for example, ambulation, prolonged standing).

3. There is documentation of failure to respond adequately to at least 3 months of conservative therapy which includes activity modification, home exercise, protective weight bearing, and analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs [NSAIDs]) or the individual is unable to tolerate conservative therapy because of adverse side effects.

4. There are no contraindications to the injections (for example, active joint infection, bleeding disorder).

A repeat course of viscosupplementation (J7325) is considered medically necessary for the treatment of pain due to osteoarthritis of the knee for individuals who meet ALL of the following criteria: 

1. The individual met all of the criteria for an initial course of treatment. 

2. Six (6) months, or more, have elapsed since the conclusion of the prior treatment cycle.

3. There is documentation that the prior course of treatment resulted in pain relief and improvement in functional status.

Paramount does not cover viscosupplementation for the treatment of osteoarthritis in locations other than the knee because it is considered experimental, investigational or unproven.
- 2 -

Viscosupplementation (J7325) for osteoarthritis of the knee should be reported with injection procedure code 20610.  Procedures J7325 will be denied when reported with procedures 20600, 20604, 20605, 20606, for locations other than the knee (e.g. temporomandibular, acromioclavicular, wrist, elbow, or ankle, olecranon bursa). Preferred and Medically Necessary Brand of Viscosupplement: There are several brands of viscosupplement on the market. There is a lack of reliable evidence that any one brand of viscosupplement is superior to other brands for medically necessary indications.


Consequently, because other brands of viscosupplement are at least as likely to produce equivalent therapeutic results, no other brands of viscosupplement (C9471, J7321-J7324, J7326-J7328, & Q9980) will be considered medically necessary unless the member has a documented contraindication or intolerance to Paramount’s preferred brand of viscosupplement: Synvisc or Synvisc-One (J7325).


Medicare is establishing the following limited coverage for CPT/HCPCS codes J7321, J7323, J7324 and J7325:

Covered for:
715.16
Osteoarthrosis, localized, primary, lower leg
715.26
Osteoarthrosis, localized, secondary, lower leg
715.36
Osteoarthrosis, localized, not specified whether primary or secondary, lower leg
715.96
Osteoarthrosis, unspecified whether generalized or localized, lower leg
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.

Guidelines from Oxford insurance

Special Considerations 1Precertification is not required in the office for Oxford's preferred products of Euflexxa, Synvisc or Synvisc-One (J7323 and J7325).

2Precertification is required for services covered under the Member's General benefits package when performed in the office of a participating provider. For Commercial plans, precertification is not required, but is encouraged for out-ofnetwork services performed in the office that are covered under the Member's General benefits package. Ifprecertification is not obtained, Oxford may review for medical necessity after the service is rendered.

3Precertification with review by a Medical Director or their  Designee is required in all sites of service for J7320, J7321, J7322, J7324, J7326, J7327, J7328, and J3490. 4Precertification is not required in the office for CPT codes 20605, 20606, 20610, and 20611.

Intra-articular hyaluronan injections, Euflexxa (1% sodium hyaluronate), and Synvisc (Hylan G-F 20) or  Synvisc-One (Hylan G-F 20), are proven and medically necessary for members with osteoarthritis of theknee who meet all of the following criteria:

* The member has documented symptomatic osteoarthritis of the knee;
* The member reports pain which interferes with functional activities (e.g., ambulation, prolonged standing);
* The member has not responded adequately to conservative therapy which may include physical therapy or

pharmacotherapy (e.g., non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen and/or topical capsaicin cream) or injection of intra-articular steroids and such therapy has not resulted in functional improvement after atleast 3 months, or the member is unable to tolerate  conservative therapy because of adverse side effects;

* The pain cannot be attributed to other forms of joint disease; and

* There are no contraindications to the injections (e.g., active joint infection, bleeding disorder). Hyalgan and Supartz (J7321), Orthovisc (J7324), Gel-One (J7326), Monovisc (J7327), Gel-Syn (J7328), GenVisc 850 (J7320), and Hymovis (J7322)

Pre-certification is required in all settings for J7320, J7321, J7322, J7324, J7326, J7327, J7328 and J3490.

Intra-articular hyaluronan injections, Hyalgan (sodium hyaluronate) and Supartz (sodium hyaluronate), Orthovisc (high molecular weight form of hyaluronic acid), Gel-One (hyaluronan), Monovisc (cross-linked sodium hyaluronate), Gel-Syn (sodium hyaluronate), GenVisc 850 (sodium hyaluronate), and Hymovis (hyaluronic acid) are proven and medically necessary for members with osteoarthritis of the knee who have met the criteria above and:

* The member has a history of failure, contraindication or intolerance documented trial and failure to Synvisc, Synvisc-One or Euflexxa.

Intra-articular injections of sodium hyaluronate are proven and medically necessary for treating temporomandibular joint (TMJ) disc displacement and osteoarthritis. Sodium hyaluronate preparations are unproven and not medically necessary for treating any other indication not listed above as medically necessary including but not limited to:

* Pain due to osteoarthritis in any joint other than the knee or TMJ
* Any other form of arthritis [including rheumatoid arthritis (RA)]
* Patello-femoral syndrome
* Chondromalacia of the knee
* Following total or partial knee joint replacement

Increase in viscoelasticity of synovial fluid after sodium hyaluronate injection has not been demonstrated in patients with rheumatoid arthritis, and it has not been determined whether sodium hyaluronate is protective in joints affected by rheumatoid arthritis. Further studies are needed to determine the safety and durability of such treatment for patello-femoral syndrome and chondromalacia of the knee and whether it significantly delays the need for more invasive treatment, e.g., surgery, joint replacement or arthroplasty. There are no clinical studies evaluating the use of sodium hyaluronate in persons following total or partial knee joint replacement surgery. Hyaluronic acid gel preparations to improve the skin's contour and/or reduce depressions due to acne, scars, injury or wrinkles are considered cosmetic. The use of sodium hyaluronate preparations to improve the skin's contour and/or reduce depressions in the skin due to acne, scars, injury or wrinkles improves physical appearance but does not remove or improve a functional impairment of the skin.

Subsequent Course of Administration/Treatment Repeated courses of intra-articular sodium hyaluronan injections of the knee may be considered proven and medically necessary under the following conditions:

* Documentation of significant pain relief achieved with the prior course of injections; and
* Pain has recurred; and
* At least six (6) months have passed since the prior course of treatment.

HCPCS Code Description

J3490 Unclassified drugs
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


Coding Clarification: Sodium Hyaluronate is unproven and not medically necessary for any other diagnosis not listed as proven. This also includes any other form of arthritis other than osteoarthritis (OA) of the knee and TMJ or for any other condition not included in this policy.


Diagnoses That DO NOT Support Medical Necessity
All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.
Documentation Requirements
  • Documentation supporting the medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
  • An appropriate diagnosis code must be submitted on the claim. The patient’s medical record should indicate the signs/symptoms supporting the diagnosis and functional impairment. The appropriate records documenting the improvement must be maintained in the medical record and made available to Medicare upon request.
  • An X-ray report of the knees must be available in the event of a review.
  • Medical records should reflect failure of conservative treatment defined as physical therapy and use of simple non-narcotic analgesics including acetaminophen.

Empire BlueCross BlueShield  Professional Reimbursement Policy

Frequency Restriction             Category/Description               Codes

2 per date of service 

Hyalyronan or derivative…for intraarticular injection, per dose

J7321, J7323, J7324, J7326



Drug Wastage Documentation Requirements
Any amount wasted must be clearly documented in the medical record, regardless of whether the JW modifier will be used in billing for the drug/biological, with:
  • Date and time.
  • Amount of medication wasted.
  • Reason for the wastage.

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