UPDATES: Changes in Maryland PDMP Dispenser Reporting Requirements
Data Collection Vendor Change:
Maryland PDMP has contracted with a new data collection vendor, RxGov, which has begun accepting data submissions. Dispensers, or their authorized data submitter, must begin reporting data to RxGov by June 1, 2019
. Every data submitter account currently registered with the existing RxSentry platform will be migrated to the new vendor, RxGov. Here is the new MD PDMP RxGov Data Submitter Reference Guide
, which contains the new data submission requirements. Also see Frequently Asked Question #11 below. If you would like assistance with the transition, contact the MD PDMP Help Desk by email firstname.lastname@example.org
or call 1-844-767-4767 (24/7/365).
Daily Reporting Change: Maryland statute governing the PDMP was amended (HB437/Chapter 147, 2016) to change the dispenser reporting frequency in line with national PDMP best practices. All non-exempt dispensers of CDS medications are required to report applicable dispenses every 24 hours to the Maryland PDMP, including submission of zero reports if no dispensing occurs. ‘Zero reports’ will be required on any day that the dispenser does not dispense a CDS prescription, regardless of whether or not the dispensing facility is open for business that day. Monitoring for compliance with the daily reporting requirement will begin July 1, 2019.
Please click below for the correspondence that we have sent to dispensers regarding the regulations change and the vendor migration:
- Faxed to pharmacies holding a CDS permit and mailed to physicians holding a dispensing permit from their Board on April 10, 2019: 1st Correspondence
- Faxed to pharmacies holding a CDS permit on April 24, 2019: 2nd Correspondence
- Faxed to pharmacies holding a CDS permit on May 17, 2019: 3rd Correspondence
Frequently Asked Questions
1. Who qualifies as a dispenser?
In general, dispensers are persons or entities authorized to dispense controlled dangerous substances (CDS) to a patient or a patient’s agent in Maryland. This includes:
- Pharmacies (both in-state and non-resident) with a permit from the Maryland Board of Pharmacy that are also registered with the federal Drug Enforcement Administration (DEA) and the MDH Office of Controlled Substances Administration to dispense CDS; and
- Healthcare practitioners that are registered with DEA and the MDH Office of Controlled Substances Administration AND have a prescription drug dispensing permit issued by their licensing board. Additional information for practitioners dispensing CDS in an office setting, can be found in the Dispenser Reporting Requirements fact sheet.
However, certain types of pharmacies, clinics and practitioners are NOT considered as a dispenser for PDMP purposes and are therefore EXEMPT from reporting to the Program. These include:
- Licensed hospital pharmacies that only distribute CDS for direct administration to an inpatient of the hospital. Please note that hospital-based pharmacies that dispense any CDS on an outpatient basis are not exempt from reporting. These pharmacies must report all outpatient dispensing to the PDMP. However, distribution of CDS drugs to licensed healthcare practitioners for direct administration to hospital inpatients should not be reported. Also, hospital-based outpatient dispensing of CDS drugs by healthcare practitioners (e.g., dispensing of “starter doses” to patients treated and released from an emergency department) must be reported to the PDMP. This is considered practitioner dispensing and should be reported under the practitioner’s DEA number.
- Pharmacies issued a waiver permit under COMAR 10.34.17.03 by the Maryland Board of Pharmacy (“waiver pharmacies”) that provide pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities. Please note that specialty pharmacies that only serve these types of facilities but do not have a waiver permit are NOT exempt from reporting. To verify if your pharmacy has a waiver permit, please call the Board of Pharmacy at 410-764-4755.
- Opioid maintenance programs that are licensed under Health-General Article § 8-404, Annotated Code of Maryland and comply with Code of Federal Regulations 42, Part 8 and COMAR 10.47.02.11.
- Veterinarians licensed under Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland when dispensing controlled substances for animals in the usual course of providing professional services.
2. I qualify as a dispenser. What am I required to do?
Dispensers are required by law to electronically report data on CDS prescription drugs dispensed to a patient or a patient’s agent in or into the State of Maryland. Dispensers must register with and report to NIC, the State’s authorized agent for PDMP data collection. For details on registration, see “Chapter 4: Data Submission” in the MD PDMP RxGov Data Submitter Reference Guide
or contact the MD PDMP Help Desk by email at email@example.com
or call 1-844-767-4767 (24/7/365)
3. What CDS drug schedules are monitored?
The MD PDMP is required by law to monitor the prescribing and dispensing of prescription drugs that contain a Schedule II, III, IV, or V CDS as designated under Title 5, Subtitle 4 of the Criminal Law Article, Annotated Code of Maryland.
With few exceptions, Maryland’s CDS schedules parallel those in federal law. The MDH Office of Controlled Substances Administration maintains a list of drugs included in the Maryland CDS schedules that are not included in the federal schedules. This list is routinely updated and posted on the OCSA website.
Note: Additions or deletions of other drugs specified by Maryland law may happen periodically. These changes must go through the legislative process in order to be added or deleted. You will be notified of any changes that are made in the future.
4. Are there any exceptions to the reporting requirement?
For information on the types of pharmacies, clinics and practitioners that are exempt from the PDMP reporting requirement, see “Who qualifies as a dispenser?” above.
Additionally, certain types of drug delivery are not required to be reported, including:
- Direct administration of CDS to a patient.
- Provision of patient drug samples (in accordance with Health Occupations Article, Section 12-102(d), Annotated Code of Maryland). Please note that samples must be packaged and distributed in compliance with federal requirements to meet the reporting exception. 'Drug sample' means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug (21 CFR 203.3). Drug samples are usually pre-packaged by the manufacturer, and distributed to prescribers by the manufacturer's representatives.
- Inpatient Hospice Dispensing: Pharmacies that dispense CDS to patients in an inpatient hospice facility may apply to MDH for a waiver from reporting PDMP data on dispensing to hospice inpatients. This waiver only applies to dispensing to inpatients in facilities that are currently licensed as a “general license hospice” by the MDH Office of Health Care Quality (OHCQ) AND have a valid “Certificate of Need” issued by the Maryland Health Care Commission (MHCC). Pharmacies issued an inpatient hospice waiver will still have to report all other CDS dispensing (i.e., outpatient dispensing). To apply for a waiver, pharmacies must provide information on how they will differentiate dispensing to hospice inpatients from other dispensing required to be reported and also will be subject to unannounced, on-site inspections by the MDH to verify reporting on dispensing that is not to hospice inpatients. Waivers shall be effective for 2-year periods and may be renewed.
5. I dispense small quantities of CDS drugs to patients being discharged from the hospital. Do I need to report this?
CDS dispensing must be reported unless the drug meets the definition of a sample (see “Are there any exceptions to the reporting requirement?” above). There is no exception from the reporting requirement for small drug quantities.
6. Can I apply for a waiver from the reporting requirement?
No. The Maryland PDMP cannot issue blanket waivers from the reporting requirement to pharmacies or practitioners that are not otherwise exempt by law (for exemptions, see “Who qualifies as a dispenser?” above).
Pharmacies and practitioners that meet the definition of “dispenser” are required to register with the Program. However, pharmacies that are not exempt from the reporting requirement but do not stock or dispense CDS prescription drugs may submit an attestation to the fact and receive a waiver from the registration requirement.
7. What information do I have to report?
For each prescribed CDS drug that is dispensed in Maryland, the dispenser must report identifying information for the drug, patient, prescriber and dispenser. For a complete list of required data elements, see “Chapter 3: Data Collection and Reporting Requirements” in the MD PDMP RxGov Data Submitter Reference Guide
8. How often do I have to report?
Effective October 8, 2018, dispensers are required to report CDS prescription drug dispenses to the PDMP every 24 hours and to submit daily zero reports if no CDS dispensing has occurred. Enforcement of this new requirement will begin on July 1, 2019; however, dispensers are encouraged to report daily now.
9. Is there a fee to report data?
10. When do I need to start reporting?
The PDMP reporting requirement became effective on August 20, 2013. MDH has requested that dispensers report data on CDS dispensing from January 1, 2013.
11. How do I report?
Dispensers are required to report to the program by electronic means. If you are a chain pharmacy, your data will likely be submitted from your home office. Please verify this with your home office. If you are an independent pharmacy or dispensing practitioner that works with a pharmacy or practice management system vendor, please forward the reporting requirements to your software vendor. System changes may be necessary to create the data file, and they may be able to submit the data on your behalf.
NIC is the State’s authorized agent for PDMP data collection. NIC offers dispensers a number of electronic reporting options, including SFTP with option of using RSA certificates or Username/Password for authentication and data entry into the Universal Claim Form. For details on data submission options, see “Chapter 4: Data Submission” in the MD PDMP RxGov Data Submitter Reference Guide
Based on the delivery method you wish to use, you will use one of the following addresses to upload your data files:
12. What data submission format will I use?
Maryland requires that dispensers submit reports using the American Society for Automation in Pharmacy (ASAP) Standard for Prescription Monitoring Programs Version 4.2 (2011). If you have any questions, contact your pharmacy vendor, or you may contact the MD PDMP Help Desk at firstname.lastname@example.org
or 1-844-767-4767 (24/7/365).
For more information regarding specifications or to acquire the full Implementation Guide for the ASAP4.2 Standard, contact the American Society for Automation in Pharmacy at www.asapnet.org.
The Implementation Guide includes field lengths, acceptable attributes, and examples. Please contact the American Society for Automation in Pharmacy
to purchase the 2011 ASAP Version 4.2 Standard.
13. Do I need to send a zero report if I do not dispense CDS drugs during the reporting period?
Effective October 8, 2018, the MD PDMP does require dispensers to submit 'zero' or 'null' reports when no CDS prescription drugs have been dispensed during a 24-hour period. Enforcement of this new zero reporting requirement will begin on July 1, 2019, however, dispensers are encouraged to report daily now.
If your pharmacy/office/facility is closed during a 24-hour period, then you should submit a zero report for that day on the next business day. If your pharmacy/office/facility is closed for more than one day in a row, then you will need to submit separate zero reports for each day.
14. Will I receive a submissions report?
Yes. You will receive your report via e-mail for all methods of submission. If you submit data via SFTP, you will receive an e-mail if there are any errors. Additionally, a report will be available in your submissions tab within RxGov.
15. What are the requirements for valid NDC numbers?
NDCs are 11 digits and use the format 99999-9999-99.
When adding an NDC, do not include the dashes, for example, 99999999999.
NDCs are typically located on the original medication bottle on the top right corner of the label, prefaced with “NDC-” and followed by the number.
Manufacturers often leave off a zero in the NDC. In these instances, you should add the 0 where appropriate, using the following examples as a guideline:
|1234-5678-90 (missing 0 in first segment)
|54321-123-98 (missing 0 in second segment)
16. Since NDC Number is a required field, what do I use for compounded drugs that do not have an NDC number?
You should use all 9’s in the NDC field for compounded drugs and then use the fields in the CDI segment. This will allow you to put the NDC numbers that you used to make the compound in the CDI segment. In the NDC field for the DSP segment you will just need 99999999999.
17. What errors do I need to correct and resubmit beginning with my August 20, 2013 submission?
A single record may be rejected if it has a fatal error. All fatal errors must be corrected and resubmitted. For minor and serious errors, we strongly recommend you change them in your system but don’t resubmit them. That will prevent the same errors from occurring on future data submissions. In addition, an entire batch may be rejected if ALL records have fatal or serious errors, more than 10% of records have fatal errors, or more than 20% of records have serious errors. In these cases the errors need to be corrected and the entire batch must be resubmitted. The MD PDMP RxGov Data Submitter Reference Guide
.will show you the edit definitions describing what is considered a fatal, serious, or minor error in the system.
18. What if I have forgotten the upload account user name or password?
In RxGov, your account user name is your email address, and you can reset your password by clicking on the Forgot Password? link on the RxGov login page: https://mdpdmp.rxgov.com. If you are still having trouble, please contact the MD PDMP Help Desk by email at email@example.com or call 1-844-767-4767 (24/7/365).
19. Who should I contact with questions?
If you need technical assistance, please contact the MD PDMP Help Desk by email at firstname.lastname@example.org
or call 1-844-767-4767 (24/7/365).
If you have non-technical questions regarding the Maryland PDMP, please send an email to email@example.com
or call 410-402-8686.
20. I am a pharmacist. How do I access PDMP data for patient care?
Pharmacists may register with CRISP
and access data through the CRISP Health Information Exchange query portal.
21. Do veterinarians need to report dispenses to the PDMP?
Dispensing of CDS in the veterinary clinic setting is exempt from reporting to the PDMP, and veterinarians who dispense do not need to complete a Practitioner Dispenser Exemption Attestation Form.