On October 12, 2015, things changed when the U.S. Centers for Medicare and Medicaid Services (CMS) granted pass-through status for a new contrast agent, Lumason (sulfur hexafluoride lipid-type A microspheres), manufactured by Bracco Diagnostics. CMS has added it to the OPPS pass-through list through December 31, 2017.
Under federal statute, transitional pass-through payments can be made for at least two years but not more than three years. Contrast material is not separately paid by Medicare for outpatient hospitals under OPPS unless the product has pass-through status. This additional payment is unique to Lumason among contrast agents used in ultrasound procedures and designed to cover new products and technologies.
In October 2014, Lumason, known globally as SonoVue, was approved by the U.S. Food and Drug Administration (FDA) for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients. Lumason is now the first ultrasound contrast agent to obtain FDA approval for use in liver imaging, to improve the sensitivity and specificity of ultrasonography for differentiating between malignant and benign focal hepatic lesions. This approval also makes Lumason the first ultrasound contrast agent approved for use in the pediatric population.
Guidelines for coding
From October 1, 2015, through December 31, 2016, Lumason was reported by outpatient hospitals with the following Healthcare Common Procedure Coding System (HCPCS) code: C9457 -- injection, sulfur hexafluoride lipid microsphere, per mL.
For claims with dates of service (DOS) on or after January 1, 2016, hospitals must use the following permanent HCPCS code for Lumason, which applies to both hospital and nonhospital providers: Q9950 -- injection, sulfur hexafluoride lipid microspheres, per mL, with payment updates provided quarterly by CMS.
Outpatient hospitals report the echocardiogram with contrast using special C-codes (C8921-C8930) instead of current procedural terminology (CPT) codes (93303-93352). In the case of the liver ultrasound exams, the CPT codes are 76700 and 76705. The HCPCS code Q9950 for Lumason needs to be listed separately from the procedure and the billing unit is per mL. Medicare allows providers to bill the discarded amount for single-dose vials such as Lumason; the modifier JW may be required for the discarded amount.
Source of pass-through payment
Section 1833(t)(6) of the Social Security Act authorizes transitional pass-through payments for the additional costs of innovative Medicare devices, drugs, and biologicals. (See https://www.ssa.gov/OP_Home/ssact/title18/1833.htm.)
The Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (Public Law 106-113) requires the Secretary of the Department of Health and Human Services to make additional payments to hospitals for the following:
- Radiopharmaceutical drugs or biological products used in diagnostic, monitoring, and therapeutic nuclear medicine procedures when used as an outpatient hospital service
- Orphan drugs
- Drugs and biological agents and brachytherapy sources used for the treatment of cancer
To receive additional payments, the above must be "current," which means they have been paid as a hospital outpatient department service since December 31, 1996.
"Transitional pass-through payments are also provided for certain 'new' drugs, devices, and biological agents" that are not current and "whose cost is 'not insignificant' in relation to the OPPS payment for the procedures or services associated with the new drug, device, or biological," according to CMS.
To collect historical cost data, which may assist with future payment packaging decisions, CMS directs hospitals to report all appropriate HCPCS codes and charges for separately payable drugs and the applicable drug administration codes. They should also report the HCPCS codes and charges for drugs that are packaged into payments for the corresponding administration or other separately payable services.
Drugs are billed in multiples of the dosage specified in the HCPCS code long descriptor. If the drug dose used in the patient's care is not a multiple of the HCPCS code dosage descriptor, the provider rounds to the next highest unit based on the code's long descriptor in order to report the dose provided.
By law, drugs that are granted pass-through payment status must be paid either the Medicare physician fee schedule rate or the Part B drug competitive acquisition program (CAP) rate (if the drug is included in that program).
Donna Richmond is a senior healthcare consultant, clinical consulting services, for Panacea Healthcare Solutions. In addition to her coding hotline responsibilities for Panacea, she performs a variety of radiology and cardiology audits and contributes to several webcasts and publications, including MedLearn Publishing's new Basics of Interventional Radiology Coding book.
For more information about reimbursement for Lumason, contact Donna at 800-349-1388.
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