3 Colo. Code Regs. § 719-1-23.00.00
Current through Register Vol. 47, No. 20, October 25, 2024
Section 3 CCR 719-1-23.00.00 - ELECTRONIC PRESCRIPTION MONITORING PROGRAM23.00.10 Definitions: a. "Bona fide investigation," for purposes of an investigation of an individual prescriber under investigation by a state regulatory board, means: 1. Any investigation conducted by any state regulatory board within the Colorado Division of Professions and Occupations, or the Director of the Colorado Division of Professions and Occupations and2. Investigations pertaining to matters which are the subject of a complaint or notice of charges pending in the Office of Administrative Courts so long as the information obtained from the PDMP is made available by the state regulatory board to the respondent in the pending case.b. "Bona fide research or education" means research conducted by qualified entities whose recognized primary purpose is scientific inquiry; the results of which would likely contribute to the basic knowledge of prescribing practitioners, dispensing pharmacists, or entities for the purpose of curtailing substance abuse of consumers. The Board shall determine in its discretion on a case-by-case basis whether an individual or entity seeking access to the PDMP pursuant to section 12-280-404(6), C.R.S., constitutes "bona fide research or education" conducted by qualified personnel for purposes of satisfying the statutory limitations therein.c. "Client", as it pertains to a licensed veterinarian's use of the PDMP, means the patient's owner, the owner's agent, or a person responsible for the patient.d. "Clinical patient care services" means pharmaceutical care provided in a clinical setting. The pharmacist providing clinical patient care services must be working closely with the physician/prescriber responsible for the patient's care. "Clinical patient care services" do not include monitoring previously dispensed prescriptions for any purpose in the absence of a current assessment of a patient whether in a clinical setting or not.e. "Law Enforcement Official" means any of the following: 3. Certified deputy sheriff;5. Southern Ute Police Officer;6. Ute Mountain Ute police officer;8. CBI director and agents;9. Colorado state patrol officer;10. Colorado attorney general and any entity designated as "peace officers" by the Attorney General or acting on behalf of a state agency;11. Attorney general criminal investigator;12. District attorney and all assistants, deputies, etc. statutorily defined as "peace officers;"13. District Attorney Chief investigator and investigators;14. Police administrator and police officers employed by the Colorado State Hospital in Pueblo; and15. Federal special agents.f. "Legitimate program to monitor a patient's controlled substance abuse" means a program in which prescribers actively monitor a patient's controlled substance use. Such programs shall only involve patients in pain management or other controlled substance management programs. Such programs shall actively monitor the patient's controlled substance usage by means of urine or other drug screens in addition to the use of the PDMP. The patient must be informed in writing that his/her controlled substance usage is being actively screened by various methods, including review of the PDMP.g. "Mistreat", as it pertains to a licensed veterinarian's use of the PDMP, means every act or omission which causes or unreasonably permits the continuation of unnecessary or unjustifiable pain or suffering.h. "Patient", as it pertains to a licensed veterinarian's use of the PDMP, means an animal that is examined or treated by a licensed veterinarian and includes herds, flocks, litters and other groups of animals.i. "PDMP" means the Electronic Prescription Drug Monitoring Program.j. "Prescriber" or "practitioner" means a licensed health care professional with authority to prescribe a controlled substance.k. "Prescription Drug Outlet" or "Dispenser" means any resident or nonresident pharmacy registered with the Board.l. "Qualified personnel" means persons who are appropriately trained to collect and analyze data for the purpose of conducting bona fide research or education.m. "Valid photographic identification" means any of the following forms of identification which include an identifying photograph: 1. A valid driver's license, or identification issued by any United States state;2. An official passport issued by any nation; or3. A United States armed forces identification card issued to active duty, reserve, and retired personnel and the personnel's dependents.n. "Zero Report" means a report submitted through the Colorado PDMP data submission environment confirming that no prescription dispensing transactions that would be required to be reported to the PDMP were completed for that date.23.00.30 Data Submission Timeline. a. Every prescription drug outlet must ensure that all controlled substance dispensing transactions are reported to the PDMP on a daily basis by no later than the outlet's next regular business day.b. Prescription drug outlets that did not complete any controlled substance dispensing transactions for a date where the prescription drug outlet was open for business are required to submit a Zero Report to the Colorado PDMP for that date by no later than the next regular business day.c. Within 14 days of receiving its Out of State Prescription Drug Outlet (OSP) registration, out-of-state prescription drug outlets must submit a written attestation to the Board using the Board's approved Attestation form to exempt the out-of-state prescription drug outlet from prescription data reporting and Zero Reporting requirements.d. Within 14 days of receiving its DEA license, In-state prescription drug outlets (PDO registration) must submit a written attestation to the Board using the Board's approved Attestation form to exempt the prescription drug outlet from prescription data and zero report requirements.e. Prescription drug outlets that fail to report controlled substance dispensing transaction data or Zero Reports to the Colorado PDMP twice within a 30-day period will be referred to the Board of Pharmacy for possible discipline.23.00.40 Data Submission Format. Prescription drug outlets shall submit to the PDMP the required data fields listed below:
a. Version/Release Number (TH01)b. Transaction Control Number (TH02)c. Transaction Type (TH03)g. Segment Terminator Character (TH09)h. Unique Information Source ID (IS01)i. Information Source Entity Name (IS02)j. Pharmacy DEA Number (PHA03)l. Pharmacy Address (PHA05)m. Pharmacy City Address (PHA07)n. Pharmacy State Address (PHA08)o. Pharmacy ZIP Code Address (PHA09)p. Patient Last Name (PAT07)q. Patient First Name (PAT08)r. Patient Address (PAT12)s. Patient City Address (PAT14)t. Patient State Address (PAT15)u. Patient ZIP Code Address (PAT16)v. Patient Date of Birth (PAT18)w. Patient Gender Code (PAT19)x. Reporting Status (DSP01)y. Prescription Number (DSP02)z. Prescription Date Written (DSP03)aa. Refills Authorized (DSP04)bb. Prescription Date Filled (DSP05)cc. Prescription Refill Number (DSP06)dd. Product ID Qualifier (DSP07, or CDI02 if a Compound)ee. Product ID (DSP08, or CDI03 if a Compound)ff. Quantity Dispensed (DSP09 and CDI04 for each ingredient if a Compound)hh. Drug Dosage Units Code (DSP11 or CDI05 if a Compound)ii. Classification Code for Payment Type (DSP16)kk. Prescriber DEA Number (PRE02)ll. Prescriber Last Name (PRE05)mm. Prescriber First Name (PRE06)nn. Detail Segment Count (TP01)oo. Transaction Control Number (TT01)23.00.50 Data Correction. a. Any errors identified by the PDMP or a prescriber shall be acknowledged and resubmitted by the prescription drug outlet within 10 business days of notification of the error.b. Prescription drug outlets that fail to correct errors identified by the PDMP within 10 business days may be referred to the Board for possible discipline.23.00.60 Patient Notification Prescription Drug Outlets shall disclose to patients receiving controlled substance prescriptions that their prescription information is being submitted to the PDMP, and that this prescription information may be queried by specific individuals for a limited number of purposes as authorized by statute.23.00.65 Unsolicited Reporting. In conjunction with other Colorado Boards who regulate prescribing practitioners and applicable stakeholders, the Board shall develop criteria for indicators of potential misuse, abuse and diversion of controlled substances and, based on those criteria, provide unsolicited reports of dispensed controlled substance prescriptions to the responsible prescribing practitioners and dispensing pharmacies of controlled substance(s) dispensed to the patient for purposes of education and intervention to prevent and reduce occurrences of controlled substance misuse, abuse, and diversion.23.00.70 Release of PDMP Information a. The individual who is the recipient of a controlled substance prescription(s) so long as the information released is specific to such individual. The procedure for individuals to obtain such information is as follows:1. The individual shall submit a written, signed request to the Board on the Board-provided form;2. The individual shall provide valid photographic identification prior to obtaining the PDMP information;3. An individual submitting a request on behalf of another individual who is the recipient of a controlled substance prescription(s) may only obtain PDMP information if the following documents are provided: (A) The original document establishing medical durable power of attorney of the individual submitting the request as power of attorney for the individual who is the recipient of the controlled substance prescription(s), and(B) Valid photographic identification of the individual submitting the request.(C) A written, signed request to the Board on the Board-provided form signed by the individual submitting the request.4. An individual submitting a request for a deceased individual ("decedent") who was the recipient of a controlled substance prescription(s) may only obtain PDMP information if the following documents are provided: (A) A state-issued Certificate of Death for the decedent.(B) A Court Order appointing the individual submitting the request as the Personal Representative of the Estate of the decedent who is the recipient of the controlled substance prescription(s).(C) Valid photographic identification of the individual submitting the request.(D) A written, signed request to the Board on the Board-provided form signed by the individual submitting the request.b. A person authorized to access the PDMP may knowingly release PDMP information specific to an individual or to the individual's treating providers in accordance with HIPAA, Pub.L. 104-191, as amended, and any rules promulgated pursuant to HIPAA without violating Part 4 of Title 12, Article 280.23.00.80 Research or Education Agreements The Board may enter into a written agreement to provide data to qualified personnel of a public or private entity for the purpose of bona fide research or education, so long as such information does not identify a recipient, prescriber, or dispenser of a prescription drug. Any public or private entity wishing to enter into or extend such an agreement shall submit a written request to the Board detailing the information it is seeking and the public benefit of such research or education. The Board will act on such request in the normal course of business.
23.00.90 Exemptions a. The following individuals or entities are exempt from reporting controlled substance dispensing transactions to the Prescription Drug Monitoring Program:1. Hospitals licensed or certified pursuant to section 25-1.5-103, C.R.S.;2. A prescription drug outlet located within a hospital licensed or certified pursuant to section 25-1.5-103, C.R.S., that dispenses controlled substances only pursuant to chart orders or dispenses no more than a 24-hour supply of a controlled substance to an outpatient. Pharmacies that meet these criteria must submit an attestation to the Board to exempt the pharmacy from daily data submission or zero reporting requirements. However, dispensations of more than a 24-hour supply must be submitted to the PDMP by the end of the following day.3. Emergency medical services personnel certified pursuant to section 25-3.5-203, C.R.S.; and4. A prescription drug outlet which has applied to the Board and received a waiver from the Board. Waivers will only be considered if the pharmacy has no electronic automation. Such requests must be submitted in writing to the Board and will be considered in the normal course of business.b. Controlled substance dispensing transactions that occur solely for Institutional Review Board (IRB) approved interventional research trials using investigational drug products that are regulated by the Federal Food and Drug Administration shall be exempt from the data submission requirements of the PDMP.c. A prescription drug outlet which has submitted a written attestation to the Board that the pharmacy will never dispense controlled substance prescriptions to Colorado patients using the Board's approved Attestation form. Prescription drug outlets with a written attestation on file are also required to attest that the prescription drug outlet will never dispense such prescriptions in its registration renewal for the prescription drug outlet to remain exempt from data submission requirements.37 CR 18, September 25, 2014, effective 10/15/201438 CR 16, August 25, 2015, effective 9/14/201539 CR 04, February 25, 2016, effective 3/16/201639 CR 19, October 10, 2016, effective 11/14/201640 CR 04, February 25, 2017, effective 3/17/201740 CR 20, October 25, 2017, effective 11/14/201741 CR 16, August 25, 2018, effective 9/17/201842 CR 21, November 10, 2019, effective 11/30/201943 CR 10, May 25, 2020, effective 5/1/202043 CR 08, April 25, 2020, effective 5/15/202043 CR 15, August 10, 2020, effective 8/30/202043 CR 20, October 25, 2020, effective 11/14/202044 CR 04, February 25, 2021, effective 3/17/202144 CR 08, April 25, 2021, effective 5/15/202144 CR 21, November 10, 2021, effective 11/30/202145 CR 20, October 25, 2022, effective 9/29/202245 CR 21, November 10, 2022, effective 11/30/202246 CR 21, November 10, 2023, effective 11/30/2023