I saw this on their website.
http://www.synviscone.com/HCP.aspx
J7325, HYALURONAN OR DERIVATIVE, SYNVISC OR SYNVISC-ONE, FOR INTRA-ARTICULAR INJECTION, 1 MG
Physican's Office
In the physician's office, all local Medicare Administrative Contractors (MACs) cover Synvisc-One and SYNVISC and their associated procedures when administered “incident to� a physician's care.
Synvisc-One® and SYNVISC® (hylan G-F 20) 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
Providers retain responsibility for determining reimbursement and insurance issues related to their patients. Genzyme cannot be responsible for failure of a provider to obtain reimbursement.
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 non pharmacologic 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. Use caution when injecting SYNVISC or Synvisc-One in patients allergic to avian proteins, feathers, or egg products; who have evidence of venous or lymphatic stasis in the leg to be treated; or who have severe inflammation in the knee to be treated.
Patients should be advised to avoid strenuous or prolonged weight-bearing activities for approximately 48 hours after treatment. Aspiration of any effusion prior to injection is highly recommended. 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 or in pregnant or lactating women. It is unknown whether SYNVISC or Synvisc-One is excreted in human milk.
For SYNVISC
In clinical trials, the most commonly reported adverse events were transient local pain, swelling, and/or effusion in the injected knee. In some cases, these symptoms have been extensive. Other side effects such as rash have been reported rarely.
View the Complete Prescribing Information for SYNVISC (PDF)
For Synvisc-One
The most commonly reported related local adverse events were transient, mild-to-moderate arthralgia, arthritis, arthropathy, injection site pain and joint effusion. No serious adverse events were reported in clinical trials in knees injected with Synvisc-One. Serious local adverse events have been reported only rarely in post-marketing use. Repeat treatment did not affect the safety profile. In the pivotal clinical trial, there was one related systemic event of syncope. The most common systemic side effects irrespective of relationship to Synvisc-One were headache, back pain, nasopharyngitis and influenza. Systemic adverse event profiles were similar between patients in the Synvisc-One and Saline Control groups.
View the Complete Prescribing Information for Synvisc-One (PDF)
Terms and Conditions of Use Privacy Policy Site Map
This site is intended for United States residents only.
© 2011 Genzyme Corporation. All rights reserved. Synvisc-One, SYNVISC and GENZYME are registered trademarks of Genzyme Corporation.