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.
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:
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 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.
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.
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.
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.
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.