For U.S. Healthcare Professionals Only
Prescribing Information
Important Safety Information  |   Prescribing Information For U.S. Healthcare Professionals Only

Important Safety Information: SYNVISC and Synvisc-One are contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the target knee. Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence. View More

A A A

Medicare

Synvisc-One® (hylan G-F 20) and SYNVISC® Medicare coverage

Physician's office

In the physician’s office, all local Medicare Administrative Contractors (MACs) cover Synvisc-One® and SYNVISC® (hylan G-F 20) and their associated procedures when administered "incident to" a physician's care.

Synvisc-One and SYNVISC must be:

  • Administered in the physician's office by a physician or auxiliary personnel under the physician's supervision
  • Provided by and represent a cost to the physician. This means the physician must Buy and Bill the product

Coverage for Synvisc-One and SYNVISC depends on the specific billing and medical utilization guidelines that have been established by the MAC. These policies are known as Medicare local coverage determinations (LCDs). All MACs cover Synvisc-One and SYNVISC, along with associated procedures when appropriate, and each contractor has published written coverage policies.

Generally, Medicare considers Synvisc-One and SYNVISC to be medically necessary when the patient had documented knee pain due to OA, and has failed to respond to conventional therapies such as nonsteroidal anti-inflammatory drugs (NSAIDs) or other conservative therapies.

Comprehensive documentation of your patients’ medical charts is essential for billing third-party payers. Comprehensive documentation assists MACs in understanding the rationale for services billed and is critical in the event a claim is denied, due to requiring additional information or evidence of medical necessity. Documentation must always support the claims submitted for payment, and address elements such as:

  • Patient history
  • Other medical services
  • Treatment rationale
  • Previous treatment with Synvisc-One or SYNVISC

Hospital outpatient

MACs and Fiscal Intermediaries (FIs) are responsible for setting policy for drugs and biologics administered in the hospital outpatient setting. Synvisc-One and SYNVISC used in the hospital outpatient setting are covered when medically appropriate, based on the coding and reimbursement mechanism described below.

  • Medicare reimburses for hospital outpatient services under the Outpatient Prospective Payment System (OPPs), using Ambulatory Payment Classification (APC) payment rates
  • A single hospital outpatient encounter may qualify for multiple APC payments, based on the type and number of services rendered
  • Some drugs and supplies are bundled into the payment for the procedure APC, while others, such as Synvisc-One and SYNVISC, are reimbursed separately

Synvisc-One® and SYNVISC® Medicare reimbursement

Physician's office

Medicare reimbursement for drugs and biologics administered in the physician’s office is based on average sales price (ASP), which for single-source drugs, is defined as the weighted average of sales of the product’s NDCs across all channels (e.g., retail, hospital, and clinic). Volume discounts, prompt pay discounts, cash discounts, charge-backs, and rebates are all taken into account in the calculation of a product’s ASP. Medicare determines an ASP payment per billing unit of the product’s HCPCS code.

Synvisc-One and SYNVISC are reimbursed using a blended, multiple-source ASP formula. This means that the ASP-based allowable per HCPCS billing code J7325, for Synvisc-One and SYNVISC, will depend on both products’ ASP amounts, as well as the number of units of each NDC sold during the quarter.

  • The Medicare allowable payment for Synvisc-One and SYNVISC is ASP + 4.3% and is updated quarterly, based on sales in previous quarters.
  • Medicare reimburses 80% of the allowed payment amount patient, or patient’s secondary insurer/supplemental plan, is responsible for remaining 20%.

Administration:

  • Medicare also provides reimbursement for the administration of Synvisc-One and SYNVISC through the CPT code 20610 (arthrocentesis, aspiration and/or injection of a major joint or bursa)
  • State-based rates vary based on geographic wage differences

Bilateral procedures:

  • Physicians receive 150% of the payment amount for 20610.
  • Medicare reimburses 80% of the allowed payment amount patient, or patient’s secondary insurer/supplemental plan, is responsible for remaining 20%.

Hospital outpatient

Within the hospital outpatient department, Synvisc-One and SYNVISC are covered as Separately Covered Outpatient Drugs (SCODs), which are paid at a rate of ASP + 4%. Of this allowable rate, Medicare will reimburse 80%, and the patient or patient’s secondary insurer is responsible for the remaining 20% coinsurance.

Administration:

Medicare also reimburses for the administration of Synvisc-One and SYNVISC when provided in the hospital outpatient setting. Under the OPPS, Medicare reimburses the hospital outpatient department for CPT 20610 (arthrocentesis, aspiration, and/or injection of a major joint or bursa) under a fixed procedure APC payment rate. State payment rates will vary based on geographic wage indices.

Physicians should bill Medicare separately for their professional services given in the hospital outpatient setting that are associated with Synvisc-One and SYNVISC.

Bilateral procedures:

When a bilateral procedure is done, the reimbursement allowable to physicians and hospitals is 150% of the payment for CPT 20610. Of this amount, Medicare will reimburse 80%, and the patient or patient’s secondary/supplemental insurer will reimburse the remaining 20% coinsurance.

Find Prior Authorization Forms

Please refer to Billing Codes for other relevant codes needed to ensure proper claim submission for Synvisc-One and SYNVISC.

Providers retain sole responsibility for determining reimbursement and insurance issues related to their patients and for ensuring the accuracy of their submission claims. Sanofi cannot be responsible for failure of a provider to obtain reimbursement.

Specialty
Pharmacy Forms

Find prior authorization
forms and other
important forms.

Reimbursement
Resources

Learn how Sanofi
Patient Connection is
here to support you.

Indication

SYNVISC® (hylan G-F 20) and Synvisc-One® (hylan G-F 20) are indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen.

Important Safety Information

SYNVISC and Synvisc-One are contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the target knee.

Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence. Do not inject SYNVISC or Synvisc-One extraarticularly, into the synovial tissues, into the fat pad or joint capsule, or intravascularly.

The safety and efficacy of Synvisc-One in locations other than the knee, or for conditions other than osteoarthritis, or in combination with other intra-articular injectables, or in severely inflamed knee joints have not been established. Use caution when injecting SYNVISC or Synvisc-One in patients allergic to avian proteins, feathers, or egg products; who have evidence of lymphatic or venous stasis in the leg to be treated; or who have severe inflammation in the knee to be treated. Remove any synovial fluid or effusion before injecting SYNVISC or Synvisc-One. Strict adherence to aseptic technique must be followed to avoid joint infection. The safety and effectiveness of SYNVISC and Synvisc-One have not been established in children (≤21years old) or in pregnant or lactating women. Patients should be advised to avoid strenuous or prolonged weight-bearing activities for approximately 48 hours after treatment.

For SYNVISC

In clinical trials, the most commonly reported adverse events were transient pain, swelling, and or joint effusion in the injected knee. The following reported adverse events are among those that may occur in association with intra-articular injections, including Synvisc: arthralgia, joint stiffness, joint effusion, joint swelling, joint warmth, injection site pain, arthritis, arthropathy, and gait disturbance.

Full Prescribing Information for SYNVISC (PDF)

For Synvisc-One

The most commonly reported adverse events were arthralgia, arthritis, arthropathy, injection site pain, and joint effusion. The following reported adverse events are among those that may occur in association with intra-articular injections, including Synvisc-One: arthralgia, joint stiffness, joint effusion, joint swelling, joint warmth, injection site pain, arthritis, arthropathy, and gait disturbance.

Full Prescribing Information for Synvisc-One (PDF)