Billing and Coding: Intraarticular Knee Injections of Hyaluronan

Purified natural hyaluronates have been approved by the FDA for the treatment
of symptomatic osteoarthritis of the knee in patients who have failed to
respond to simple analgesics or conservative nonpharmacologic therapy.
Osteoarthritis leads to changes in hyaluronan, a natural substance that helps
provide the fluid within the joint with elasticity and viscosity. The
therapeutic goal of administration of intraarticular hyaluronate is to provide
and maintain intraarticular lubrication, which increases the viscoelastic
properties of synovial fluid; this form of therapy is therefore termed
"viscosupplementation." Osteoarthritis (OA) is a common condition affecting
the knee/s. Comprehensive management of OA should always include a combination
of treatment options directed toward the common goal of alleviating pain and
improving function. These include symptomatic pharmacological treatment with
analgesics, non-steroidal anti-inflammatory drugs (NSAID) and intraarticular
corticosteroid injections. Muscle strengthening exercises, weight loss, and
assistive devices such as canes have been helpful in managing osteoarthritis.

Various polymers of hyaluronic acid have been approved and marketed as
implanted prosthetic devices.

  * The FDA has approved Viscosupplementation as a device. Medicare is allowing this nonpharmacologic therapy. The contractor expects the use of those drugs and biologicals not listed here to be medically necessary and used according to their FDA indications.
  * This treatment will only be covered for the treatment of pain in osteoarthritis of the knee. All other uses will be denied as investigational.
  * All procedures are furnished by and administered by a physician and/or appropriately trained providers in the appropriate setting.
  * Documentation in the patient's medical record must support the patient failed to respond adequately over a three-month period to a past history of treatment with analgesics and conservative nonpharmacological therapy (exercise or physical therapy, weight loss if appropriate, use of assistive devices).
  * A radiological exam to support the clinical diagnosis of osteoarthritis of the knee will be available in the patient's medical record.

If subsequent courses of treatment are given, the medical records must support
the effectiveness of the prior treatment and must clearly establish reduction
of patient symptomatology and medication usage. This documentation must be
submitted upon request. Claims submitted without requested supporting evidence
in the medical record will be denied as being not medically necessary.

Repeat treatments are considered medically necessary 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 the previous series of injections which has been documented in the record; and
  * At least six (6) months have elapsed since the last injection in the series.

The Medicare program covers drugs that are furnished "incident to" a
physician's service provided, that the drugs are not usually self-administered
by the patients. Please refer to the WPS GHA Guides and Resources: Incident to
Services.

The following guidelines identify three categories in which medications would
not be reasonable and necessary according to accepted standards of medical
practice:

  * Medications given for a purpose other than the treatment of a particular condition, illness, or injury are not covered.
  * Medications administered for treatment of a disease and which exceed the frequency or duration of injections indicated by accepted standards of medical practice are not covered.
  * If a medication is determined not to be medically reasonable and necessary for diagnosis or treatment of an illness or injury according to these guidelines, the entire charge (i.e., for both the drug and its administration) is not considered medically necessary.

**Billing of Viscosupplements**  
When reporting C, J or Q HCPCS codes for hyaluronan acid therapy, it should be
noted that some codes are "per dose" and some are "per mg" as specified in the
code descriptor. When reporting a "per mg" drug code, report the appropriate
number of units that reflect the dosage given. Units of service are to be
billed in multiples of the dosage specified in the full HCPCS descriptor. This
descriptor does not always match the dose given. The units billed must
correspond with the smallest dose (vial) available for purchase from the
manufacturer(s) that could provide the appropriate dose for the patient.
Dosing frequency of injections per series and/or dosing frequency per series
as listed/supported with the FDA approved dosing/package insert must be
documented in the medical record. Providers are responsible for determining
the code that most accurately describes the intraarticular agent furnished.

**HYALURONAN Drug Dosing Tables**

**1.The following HCPCS codes are per dose codes:**

**HCPCS**  
 **Code** | **Billing**  
 **Unit** | **Drug**  
 **Name(s)** | **Dosing frequency per series**  
 **(per knee)*** | **Dose (per**  
 **knee)*** | **Units per dose**  
 **(per knee)**  
---|---|---|---|---|---  
J7321 | per dose | Hyalgan | 3 to 5 weekly injections | 20 mg once weekly | 1
unit  
J7321 | per dose | Supartz | 3 to 5 weekly injections | 25 mg once weekly | 1
unit  
J7321 | per dose | Visco-3 | 3 weekly injections | 25 mg once weekly | 1 unit  
J7323 | per dose | Euflexxa | 3 weekly injections | 20 mg once weekly | 1 unit  
J7324 | per dose | Orthovisc | 3 to 4 weekly injections | 30 mg once weekly |
1 unit  
J7326 | per dose | Gel-One  | Single injection** | 30 mg x 1 dose | 1 unit  
J7327 | per dose | Monovisc | Single injection** | 88 mg x 1 dose | 1 unit  
  
***Note:** Dose frequency and dose listed is from package insert or is FDA
approved dosing.  
 ****Note:** Gel-One and Monovisc are administered through a single intra-
articular injection.

**2.The following HCPCS codes are per mg codes (not per dose):**

**HCPCS**  
 **Code** | **Billing**  
 **Unit** | **Drug**  
 **Name(s)** | **Dosing frequency per series**  
 **(per knee)*** | **Dose (per**  
 **knee)*** | **Units per dose**  
 **(per knee)**  
---|---|---|---|---|---  
J7328 | per 0.1 mg | Gelsyn-3 | 3 weekly injections | 16.8 mg once weekly |
168 units  
J7329 | per 1 mg | TriVisc | 3 weekly injections | 25 mg once weekly | 25
units  
J7318 | per 1 mg | Durolane | Single Injection** | 60 mg x 1 dose | 60 units  
J7320 | per 1 mg | Genvisc 850 | 3 to 5 weekly injections | 25 mg once weekly
| 25 units  
J7325 | per 1 mg | Synvisc | 3 weekly injections | 16 mg once weekly | 16
units  
J7325 | per 1 mg | Synvisc-One | Single injection** | 48 mg x 1 dose | 48
units  
J7322 | per 1 mg | Hymovis | 2 weekly injections | 24 mg once weekly | 24
units  
J7331 | per 1 mg | Synojoynt | 3 weekly injections | 20 mg once weekly | 20
units  
J7332 | per 1 mg | Triluron | 3 weekly injections | 20 mg once weekly | 20
units  
  
***Note:** Dose frequency and dose listed is from package insert or is FDA
approved dosing.  
 ****Note:** Synvisc-One and Durolane are administered through a single intra-
articular injection.

**Billing subsequent injections in a series (EJ modifier)**

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.

**JW Modifier Requirement**  
Effective 01/01/2017, per CR 9603, when billing for Part B drugs and
biologicals (except those provided under CAP), the use of the JW modifier to
identify unused drugs or biologicals from single use vials or single use
packages that are appropriately discarded is required. The discarded amount
shall be billed on a separate claim line using the JW modifier. Providers are
required to document the discarded drug or biological in the patient's medical
record. Please refer to the WPS GHA Guides and Resources: Modifier JW Fact
Sheet.

**Billing the injection procedure**

  * The procedure code (CPT code) 20610 or 20611 may be billed for the intraarticular injection. The charge, if any, for the drug or biological must be included in the physician's bill and the cost of the drug or biological must represent an expense to the physician.
  * If an aspiration and an injection procedure are performed at the same session, bill only one unit for CPT code 20610 or 20611.
  * When additional substances are concomitantly administered (e.g. cortisone, anesthetics) with viscosupplementation, only one injection service is allowed per knee.
  * The appropriate site modifier (RT or LT) must be appended to CPT code 20610 or CPT code 20611 to indicate if the service was performed unilaterally and modifier (-50) must be appended to indicate if the service was performed bilaterally.
  * If the drug is denied as not reasonable and necessary, the associated injection code will also be denied.
  * Please refer to the WPS GHA Guides and Resources - Modifier 50, LT, RT Fact Sheets.

**Evaluation and management service**

  * 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.
  * An E&M service should not be reported for subsequent injections unless there was a separately identifiable problem for which the E&M service was required and rendered.
  * Please refer to the WPS GHA Guides and Resources - Modifier 25 Fact Sheet.

**Sources of Information:**  
FDA package inserts for hyaluronic acids including Safety and Effectiveness
Data;  
The Medical Letter (August 27, 2018). Two New Intra-articular Injections for
Knee Osteoarthritis. Vol. 60 (1554);  
Hunter, D. (2015) Viscosupplementation for Osteoarthritis of the Knee. NEJM,
372:1040-7.  
Other MACs LCD/Articles.  
WPS GHA Guides and Resources - Modifier JW, LT, RT, 50, and 25 Fact Sheets.