CMS recently released the official update of the HCPCS code system, and Astellas's new product, Regadenoson (trade name Lexiscan), is included in the October update.  Lexiscan is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.  The recommended dose of Lexiscan is 5 mL (0.4 mg regadenoson) by rapid intravenous injection; followed immediately by saline flush and radiopharmaceutical.  NDC for Lexiscan is 00469-6501-89 (syringe). 

ASNC members using this product should follow the coding instructions listed below when billing for Regadenoson, depending on the office setting.

Freestanding Facility & Physician Office Setting
(Now Through December 31, 2008)

Bill HCPCS Level II code J3490 (Unclassified drugs) for this product.  This HCPCS code is to be used only when a distinct HCPCS code for the drug being administered has not been released, as is the case with Lexiscan.  Whenever J3490 is used, you must include 1) the name of the drug, and 2) any pertinent information such as the name, strength, dosage administered, NDC#, and route of administration.  Medicare policy is based on 106% of the Wholesale Acquisition Cost (WAC) or invoice pricing if the WAC is not published. (The WAC is published for Lexiscan at $202.35, therefore the full Medicare allowable for this setting of care is $214.49.)  Facilities should be prepared to furnish copies of invoices upon request.

Hospital Outpatient Setting
(On or after October 1, 2008)

Effective October 1, 2008, HCPCS code C9244 (Injection regadenoson, 0.4 mg) should be used for billing Lexiscan to Medicare in the hospital outpatient setting only.  This new policy will take precedence over the previous billing instructions for billing C9399 (Unclassified drugs or biologicals) in the hospital outpatient setting.

Update: CMS has recently released the HOPPS payment rate, status indicator, and APC for HCPCS code C9244.  The payment rate is $212.47 (new drugs with a specific code but without transitional pass-through status are reimbursed by Medicare at WAC +5% in the Hospital Outpatient setting of care until an average sales price [ASP] is established), while the status indicator is K and the APC is 9244.  Additionally, the Average Wholesale Price (AWP), published in the Red Book, has been set at $242.82.

Third Party Payers

Bill HCPCS code J3490 in all patient settings, and reimbursement will be per contract.