Coverage and reporting rules for replacement of recalled or defective devices and handling of manufacturer credits:
Molina provides coverage for removal and replacement of recalled or defective medical devices when medically necessary.
Molina reserves the right to audit any claims submitted in connection with removal and replacement of recalled or defective devices; Molina may adjust payment when the facility receives full or partial manufacturer credit and is not liable for the full replacement cost.
Providers must include applicable UB-04 condition codes and value/modifier reporting as described below on inpatient, outpatient, and ASC claim forms, as appropriate.
Condition codes (place in UB-04 FL 39-41)
Condition Code 49 — product lifecycle replacement earlier than anticipated due to malfunction (warranty-based replacement). Value Code FD is usually used alongside Condition Code 49 when a full or partial manufacturer credit of 50% or more is received.
Condition Code 50 — product replacement for known recall by manufacturer or FDA. Value Code FD is usually used alongside Condition Code 50 when a full or partial manufacturer credit of 50% or more is received.
Condition Code 53 — initial placement of a medical device provided as part of a clinical trial or free sample; only for outpatient and ASC claims and not to be used on inpatient claims. When reported, Value Code FD is usually reported as well.
More than one condition code (49, 50, 53) may be reported on the same UB-04 claim only when they accurately reflect different, distinct services or different, distinct medical devices reported on that claim.
Value Code FD — report when the facility receives a full or partial manufacturer credit of 50% or more; enter FD in a value code field (FL 39a, 40a, or 41a) and place the dollar amount of the manufacturer's credit beside it (e.g., FD = $2,000). Reporting FD allows Molina to adjust payment and avoid double reimbursement.
Value Code FD is not always reported with Condition Codes 49, 50, or 53; FD is used only when the manufacturer credit impacts reimbursement.
Outpatient/ASC reporting — do not use Value Code FD on ASC claims; instead report Condition Codes 49, 50, or 53 and use modifiers FB (full credit) or FC (partial credit) in FL 44 for outpatient/ASC claim lines as applicable; attach modifier FB to the CPT/HCPCS procedure line (not the device line); device line should reflect a $0 or $1 charge when item furnished at no cost or fully credited.
Do not use modifier FC when the manufacturer credit is less than 50%; when credit is less than 50% no credit modifier is used.
For ASC, the device HCPCS line-item charge reported in FL 47 should reflect the reduced cost after partial credit is applied.
Per CMS Transmittal 11937, hospitals paid under OPPS are no longer required (effective January 1, 2014) to use modifiers FB or FC on UB-04 outpatient claims to reflect dollar amounts of manufacturer credits.
In cases of conflict, federal/state guidelines and the member benefit plan documents supersede this policy; provider contract language prevails.