Medicare Reimbursement for SYNVISC^® (hylan G-F 20) and SYNVISC-ONE^® (hylan G-F 20)

In the physician's office, all local Medicare Administrative Contractors (MACs) cover SYNVISC and SYNVISC-ONE and their associated procedures when administered "incident to" a physician's care.

SYNVISC and SYNVISC-ONE 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 and SYNVISC-ONE 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 and SYNVISC-ONE, along with associated procedures when appropriate, and each contractor has published written coverage policies.

Generally, Medicare considers SYNVISC and SYNVISC-ONE 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 or SYNVISC-ONE
    

MACs and Fiscal Intermediaries (FIs) are responsible for setting policy for drugs and biologics administered in the hospital outpatient setting. SYNVISC and SYNVISC-ONE 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 and SYNVISC-ONE, are reimbursed separately
    

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

SYNVISC-ONE and SYNVISC:

• The Medicare allowable payment for SYNVISC and SYNVISC-ONE is ASP + 6% (equates to ASP + 4.3% with the 2% sequestration) 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 and SYNVISC-ONE 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:

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

Within the hospital outpatient department, SYNVISC and SYNVISC-ONE are covered as Separately Covered Outpatient Drugs (SCODs), which are paid at a rate of ASP + 4.3%. 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 and SYNVISC-ONE 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 and SYNVISC-ONE.

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.