Section 657.37.3. Requirements for the PMP.

Each dispenser, unless identified as exempt from reporting pursuant to subrule 37.3(1), shall submit to the PMP administrator a record of each reportable prescription dispensed during a reporting period. A dispenser located outside the state of Iowa, unless identified as exempt from reporting pursuant to subrule 37.3(1), shall submit to the PMP administrator a record of each reportable prescription dispensed during a reporting period to a patient located in Iowa.

       37.3(1) Exemptions. The dispensing of a controlled substance as described in this subrule shall not be considered a reportable prescription. A dispenser engaged in the distribution of controlled substances solely pursuant to one or more of the practices identified in paragraphs 37.3(1)“a” or 37.3(1)“b” shall so notify the PMP administrator and shall be exempt from reporting to the PMP.

        a.           A licensed hospital pharmacy shall not be required to report the dispensing of a controlled substance for the purposes of inpatient hospital care, the dispensing of a prescription for a starter supply of a controlled substance at the time of a patient’s discharge from such a facility, or the dispensing of a prescription for a controlled substance in a quantity adequate to treat the patient for a maximum of 72 hours. A hospital pharmacy claiming exemption from reporting pursuant to this paragraph shall certify to the board that the hospital pharmacy dispenses only as provided by this paragraph.

        b.           A licensed pharmacy shall not be required to report the dispensing of a controlled substance for a patient residing in a long-term care facility or for a patient residing in an inpatient hospice facility. A pharmacy claiming exemption from reporting pursuant to this paragraph shall certify to the board that the pharmacy dispenses only to patients residing in a long-term care facility or to patients residing in an inpatient hospice facility.

        c.           A prescriber or other authorized person who administers or dispenses a controlled substance, including samples of a controlled substance, for the purposes of outpatient care shall not be required to report such administration or dispensing. This exception shall not apply to a pharmacist who administers a controlled substance, as directed by the prescriber, pursuant to a prescription.

        d.           A wholesale distributor of a controlled substance shall not be required to report the wholesale distribution of such a substance.

       37.3(2) Data elements. The information submitted for each prescription shall include, at a minimum, the following items:

        a.           Dispenser DEA number.

        b.           Date the prescription is filled.

        c.           Prescription number.

        d.           Indication as to whether the prescription is new or a refill.

        e.           NDC number for the drug dispensed.

        f.            Quantity of the drug dispensed.

        g.           Number of days of drug therapy provided by the drug as dispensed.

        h.           Patient name.

        i.            Patient address including street address, city, state, and ZIP code.

        j.            Patient date of birth.

        k.           Patient gender.

        l.            Prescriber DEA number.

        m.          Date the prescription was issued by the prescriber.

        n.           Method of payment as either third-party payer or patient cash payment.

       37.3(3) Reporting periods. A record of each reportable prescription dispensed shall be submitted by each dispenser at least weekly. Records may be submitted with greater frequency than required by this subrule. Records of reportable prescriptions dispensed between Sunday and Saturday each week shall be submitted no later than the following Wednesday. However, a pharmacy that is currently submitting prescription dispensing records to another state’s PMP on an alternative weekly reporting schedule may request authority to submit records to the Iowa PMP pursuant to that established schedule. The request shall be submitted in writing via e-mail, fax, or regular mail to the PMP administrator. The request shall identify the pharmacy by name, address, and Iowa pharmacy license number and shall define the alternative reporting period. The PMP administrator is hereby authorized to accept the pharmacy’s alternative weekly reporting schedule.

       37.3(4) Transmission methods. Prescription information shall be transmitted using one of the following methods:

        a.           Data upload to a reporting Web site via a secure Internet connection. The PMP administrator will provide dispensers with initial secure login and password information. Dispensers will be required to register on the reporting Web site prior to initial data upload.

        b.           Electronic media including CD-ROM, DVD, or diskette, accompanied by a transmittal form identifying the dispenser submitting the electronic media, the number of prescription records included on the media, and the individual submitting the media.

        c.           If a dispenser does not have an automated record-keeping system capable of producing an electronic report as provided in this rule, the dispenser may submit prescription information on the industry standard universal claim form. The dispenser may complete and submit the claim form on the reporting Web site or, if the dispenser does not have Internet access, the completed paper claim form may be submitted.

        d.           Chain pharmacies and pharmacies under shared ownership may submit combined data transmissions on behalf of all facilities by utilizing the secure FTP procedure.

       37.3(5) Zero reports. If a dispenser has not been identified as exempt from reporting to the PMP and the dispenser did not dispense any reportable prescriptions during a reporting period, the dispenser shall submit a zero report via the established reporting Web site. If such a dispenser does not have Internet access, the dispenser shall notify the PMP administrator via mail or facsimile transmission that the dispenser did not dispense any reportable prescriptions during the reporting period. The schedule identified in subrule 37.3(3) shall determine timely submission of zero reports.

[ARC 7903B, IAB 7/1/09, effective 8/5/09; ARC 0242C, IAB 8/8/12, effective 1/1/13]