NC Medicaid is updating Clinical Coverage Pharmacy Policy 9 to allow for donation of abandoned Long-Acting Injectable Antipsychotics (LAIs) as defined in the updated policy to a registered Drug Repository Program, as defined under and in accordance with N.C.G.S §90-85.44.
An “abandoned” LAI is defined as a LAI, which has been prescribed for a specific beneficiary, dispensed to the beneficiary’s provider for administration, and the beneficiary either fails to appear for the administration of the LAI and meets the requirements described below, or the provider obtains written documentation of the beneficiary’s refusal to receive the LAI.
For beneficiaries who have not appeared for their appointment, the LAI is considered “abandoned” 30 days past the missed date of administration of the LAI dose and after the provider attempts at least two calls to the beneficiary and has sent the beneficiary a letter of notification regarding the missed LAI dose. The LAI is considered abandoned if there is no response from the beneficiary after the three defined patient outreach attempts from the provider or if the provider documents the beneficiary’s refusal to receive the LAI.
This applies only to unused LAIs when:
- LAI has been ordered by the provider and intended for use by a Medicaid beneficiary.
- Pharmacy has released the LAI to the provider for administration and Medicaid has paid the pharmacy for the LAI.
- Medicaid beneficiary has not appeared for their appointment to receive the LAI or has otherwise declined, in writing, to receive the injection.
- The provider has made at least two phone calls and sent a letter of notification to the Medicaid beneficiary about their failure to appear for their appointment as described below.
- Provider has either been unable to contact the Medicaid beneficiary or the Medicaid beneficiary’s intent to abandon the LAI is documented as required in this policy; and
- The dispensing pharmacy is unable to take the medication back.
Medicaid beneficiaries must consent to having their abandoned LAI donated by their provider on their behalf, to a registered Drug Repository Program.
To allow for donation of an abandoned LAI by a patient covered by NC Medicaid, the provider must obtain and keep in the beneficiary’s record a signed consent of the beneficiary donor’s willingness to donate the abandoned LAI. The provider may satisfy this requirement by obtaining at the initial patient visit where the LAI is prescribed a signed authorization/consent from the Medicaid beneficiary stating that the beneficiary agrees to donate any abandoned doses of the LAI in accordance with N.C.G.S. §90-85.44.
The consent should clearly explain to a beneficiary when the LAI is considered “abandoned” as defined by NC Medicaid Clinical Coverage Policy 9 so that the beneficiary is fully aware of the point at which their medication will be considered abandoned.
Once an LAI is “abandoned,” the LAI must be donated to a registered Drug Repository Program in the original unopened container or box as defined under and in accordance with N.C.G.S. §90-85.44(b). The provider shall not re-use or administer the LAI to another patient outside of a registered Drug Repository Program.
In addition, providers must:
- Adhere to all NC Board of Pharmacy procedures and policies with respect to abandoned LAI donation.
- NOT bill Medicaid for administration of the LAI, if the medication is abandoned and donated. Providers should only bill administration fees where the Medicaid beneficiary receives the LAI.
- Clearly document ongoing psychoeducation efforts and medication management decision-making with the beneficiary for any LAI abandoned by a Medicaid beneficiary on three consecutive occasions. This includes consent or withdrawal of consent for ongoing treatment with LAIs, to reduce the likelihood of future LAI abandonment.
- Cooperate with any investigations for fraud, waste, or abuse and monitoring, as providers are subject to Medicaid Provider Participation Agreement terms.
To prevent further waste of expensive LAIs which would have otherwise been wasted, and to allow abandoned LAIs to be made available to qualifying North Carolinians through Drug Repository Programs, this addition to clinical coverage policy 9A is being posted in advance of policy promulgation and is effective immediately.
Contact
NC Medicaid Outpatient Pharmacy Program: 919-527-7657