CII-CIV Med Access

Policy: Requirements for Scheduled CII – CV Medication Access
The organization shall have controls in place that meet all DEA and State Board Requirements for controlled substances and for other medications deemed to have high potential for diversion. Vigilance is required to ensure compliance with Federal and State regulations while providing access to controlled substance medications.

Procedure:
A. Non-EMERGENT Scheduled II Controlled Substances:
Non-EMERGENT medication requests are those for chronic therapy for inclusion in participants’ monthly cycle-fills or initiation of new therapy that is not needed the same day.

  1. Profile the medication in EireneRx.
  2. The authorized practitioner prescribes scheduled II controlled substances according to State and Federal law using a state authorized prescription blank printed with the NPI serial number or ink-signed, printed prescription.
  3. The prescription is then mailed to CareKinesis (Attn: Prescription Management) the same day it is written. CareKinesis provides self-addressed, stamped envelopes for this use.
  4. Upon receipt of the original ink-signed prescription for the scheduled II controlled substance, CareKinesis will dispense the medication as indicated (i.e., for next cycle fill or business day following the date that the prescription is received).
  5. The Controlled Substance Report available in EireneRx™ may be generated to identify active controlled substance medications (CII – CV) by participant for a specific provider to write the needed prescriptions in a timely manner.

As a courtesy, CareKinesis will request prescriptions needed for the next cycle fill approximately two (2) weeks prior to the cycle start date. Prescriptions received prior to the processing of the cycle will be included in the adherence packaging or in a vial.
CareKinesis will provide courtesy outreach to Prescriber if the prescription for identified chronic therapy is not received.

IMPORTANT: If the ink-signed prescription is not received by CareKinesis within seven (7) business days prior to the cycle start date, Scheduled II controlled substances may be excluded from the cycle. These will be dispensed upon receipt.

B. EMERGENT Scheduled II Controlled Substances:
1. Emergent Scheduled II controlled substances are obtained via the community pharmacy network (CPN). The Prescriber provides the completed prescription to the chosen CPN location. CareKinesis will assist by providing demographic and billing information to the CPN pharmacy.
2. If an additional supply is needed from CareKinesis, a second ink-signed prescription is to be mailed to CareKinesis. Upon receipt, CareKinesis will dispense the prescription as indicated (i.e., for next cycle fill or business day following the date that the prescription is received).

Required Elements of Scheduled II Prescription:

  1. The Rx is dated and signed on the day of issue. The date should be written out completely.
  2. Full name, DOB and address of patient
  3. Medication name, strength, dosage form
  4. Quantity prescribed (numerically and written out)*
  5. Directions for use
  6. Zero refills**
  7. Full name and address of prescriber
  8. DEA registration number of prescriber
  9. Prescriber signature

*NOTES: 28-day supply for inclusion in cycles
**As per Federal Regulations, Scheduled II prescriptions are non-refillable.
Two prescriptions are required by federal and state regulations if obtaining a supply from a CPN and maintenance by CareKinesis.

C. Scheduled CIII – CV Controlled Substances:
Scheduled CIII through CV controlled substance prescriptions are profiled in EireneRx, similar to other non-controlled substance prescriptions. Controlled substances classified as CIII through CV may be communicated verbally to a Pharmacist or faxed to the Pharmacy according to State law. Prescriptions received electronically by CareKinesis are verified with the prescriber (or his/her agent) as verbal orders at the end of each day, prior to shipping.
If State law requires an original, ink-signed prescription, it is to be provided to CareKinesis. These prescriptions may be refilled up to maximum of 5 times or 6 months from the written date, whichever occurs first.

Required Elements of Scheduled CIII – CV Prescription:

  1. The Rx is dated and signed on the day of issue
  2. Full name, DOB and address of patient
  3. Medication name, strength, dosage form
  4. Quantity prescribed*
  5. Directions for use
  6. Refills authorized
  7. Full name and address of prescriber
  8. DEA registration number of prescriber
  9. Prescriber signature

*NOTE: 28-day supply for inclusion in cycles
Two prescriptions are required by federal and state regulations if obtaining a supply from a CPN and maintenance by CareKinesis.

Controlled Substance Compliance Reminder

Last Revision Date: 2/28/14