Occasionally, a clinician will open the packaging of a LARC method but the product is ultimately not used by a patient. This can occur due to error or accident (e.g., non-sterile technique), or an insertion that is discontinued for medical reasons or at the patient’s request. Although rare, there are also mechanical defects in the products that render them unusable.
The course of action when confronted with these circumstances depends on the primary payer for the LARC method and whether the product was issued as a benefit for a specific patient or was purchased as “buy and bill.” In general, commercial plans will reimburse the cost of LARC methods lost during failed insertions. In general, most public payers do not reimburse the cost of LARC methods lost during failed insertions. Providers should check with specific payers to determine their reimbursement policies for failed insertions. For any payer that does reimburse this cost, there is an important additional consideration: if the patient wishes to attempt another insertion and the plan limits the number of LARC methods covered within a specific timeframe, it may be beneficial to pursue reimbursement for the lost product from the manufacturer.
Requesting replacement LARC methods from manufacturers
Manufacturers of LARC methods provide replacement products under some conditions; however, they do not supply credit refunds. Providers should always keep the LARC method and record its lot number to facilitate a request for a replacement product from the manufacturer. The LARC method may need to be sent to the manufacturer as proof of the failed insertion or product defect.
Teva Women’s Health considers replacement requests for ParaGard on a case-by-case basis, and has published a detailed replacement policy. Providers should call 1-877-PARAGARD to request a replacement IUD. A representative will send a Replacement Product Request form and may also supply a postage-paid envelope. Providers must send the completed form and IUD within 30 days of receipt. A replacement product will be shipped within six weeks. The replacement process must be initiated at various times depending on the reason the device is unused:
- IUD was dropped or contaminated – initiate replacement request within one week of drop or contamination;
- insertion was discontinued for medical reasons – initiate replacement request within 30 days of failed insertion procedure; or
- product has defect – no time limit to request a replacement.
Bayer considers replacements for Mirena or Skyla on a case-by-case basis and has not published a formal replacement policy. If the failed insertion occurred within the last 60 days, a provider may be eligible for a replacement product. A provider should initiate a replacement request by contacting its Bayer representative if the IUD was dropped, contaminated, or there was a failed insertion. If there is a defect in the product, initiate a replacement request by contacting the Bayer technical complaint center at 1-888-842-2937 or [email protected].
Actavis considers replacements for Liletta on a case-by-case basis, whether caused by contamination or a defect in the product. Actavis has a published return policy. Providers that need a replacement should save the device and contact Actavis within one weekby phone at 855-545-3882, option 6, or complete a return a replacement request form by email or fax. A Liletta representative will authorize a return and send a paid shipping label within 2 business days. The contaminated or defective device must be returned within 30 days of contacting Actavis. After reviewing the returned device, Actavis will make a determination of whether to issue a replacement device.
Merck considers replacements for Nexplanon on a case-by-case basis and at the time of this guide’s publication is formalizing a replacement policy for publication. Providers should initiate a replacement request as soon as possible to help expedite replacement. Call the Merck Information Center for Nexplanon at 1-877-467-5266, select Nexplanon, and then select for adverse event and product failures. The Information Center representative will provide details about what information is needed, but a best practice has been to document the procedure by taking a photo of the implant, recording its lot number, and recording a detailed explanation of the reason for the discontinued insertion. Alternatively, a provider’s Merck representative may be able to help facilitate the process.