Billing and Coding: Intraarticular Knee Injections of Hyaluronan

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, §30.6.7(D) Payment for Office or Other Outpatient Evaluation and Management (E/M) Visits (Codes 99201-99215) - Drug Administration Services and E/M Visits Billed on Same Day of Service

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, §40 Discarded Drugs and Biologicals and §90.2 Drugs, Biologicals, and Radiopharmaceuticals

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §50.3 Incident-to Requirements and §50.4.1 Approved Use of Drug

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:

*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):

*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.