Controlled Substance Monitoring Database (CSMD) and Prescription Safety Act
Frequently Asked Questions
The Tennessee Prescription Safety Act of 2016, Tenn. Pub. Acts, ch. 1002 (2016), represents a significant effort by the General Assembly to address the problem of prescription drug abuse. The Act was signed into law by Governor Bill Haslam on April 27, 2016.
In accordance with the Controlled Substance Monitoring Act of 2002, the Tennessee Board of Pharmacy established a database to monitor the dispensing of Schedules II, III, IV & V controlled substances. Data collection began for all dispensers on December 1, 2006. The Controlled Substance Monitoring Database (CSMD) was later administratively attached to the Tennessee Department of Health. The Prescription Safety Act of 2012 enhanced the monitoring capabilities of the database. The 2016 Act provided for further enhancements.
All healthcare practitioners with DEA numbers who prescribe or dispense controlled substances in a practice providing direct care to patients in Tennessee on more than fifteen (15) days in a calendar year must be registered in the CSMD. Licensed veterinarians who never prescribe or dispense a controlled substance in an amount intended to treat a non-human patient for more than five (5) days are not required, but are encouraged to register. It is vital that each registrant provides and maintains a unique and valid e-mail address within the CSMD so that the CSMD may communicate with the registrant to ensure continued access to the database.
Healthcare practitioners or persons under the supervision and control of the practitioners, pharmacists or pharmacies who are legally authorized to dispense a schedule II, III, IV or V controlled substance are required to submit certain data to the CSMD.
The law permits practitioners to designate a delegate (previously referred to as an “extender”) to check the CSMD. The delegates must act under the supervision of a licensed healthcare practitioner.
The following Frequently Asked Questions and Answers should be of value to you in understanding the law. This is intended to provide an overview of the law and should not serve as a substitute for reading and following the statutes and rules as written. This FAQ is not intended to be comprehensive. Additional information can be found by following the link to the Prescription Safety Act of 2016. If you have any questions regarding the law, you may wish to seek legal counsel.
1. When do I need to register?
The law required registration to use the database by January 1, 2013. Thereafter, new licensees must be registered within thirty (30) days of initial registration with the DEA (for prescribing healthcare practitioners) or licensure (for dispensers).
2. How do I register to access the database?
Go to www.tncsmd.com and click on the word “register” to begin the registration process. Completion of the registration process will require specific identifying elements. Once registration is complete and approved, you will receive an email with your user name and temporary password.
3. I do not practice or live in Tennessee, but see Tennessee residents. Can I register to access the CSMD?
Yes, if you provide direct care and prescribe controlled substances to patients in Tennessee on more than 15 days per year or you are a dispenser in practice providing direct care to patients in Tennessee on more than 15 days per year, you are required to register with the CSMD. If you reside in Michigan, South Carolina, Kentucky, Arkansas, Mississippi, Alabama, Minnesota, Louisiana, North Dakota, West Virginia or Virginia, you should query Tennessee CSMD data regarding your patients via your own state’s prescription monitoring portal. However, if you do not practice in Tennessee or hold a Tennessee license, you are not required to register for access to the CSMD.
4. What is my password?
Initially the system will send you a temporary password. You will then be required upon first log-in to select a new password. The password requirements are:
- Passwords must contain a minimum of eight (8) characters
- One uppercase alphabet letter
- One lowercase alphabet letter
- One number character
- One special character (EXAMPLE: +, $, %)
5. What happens if I forget my password?
If you are unable to log in, you may select Forgot/Reset Password and provide answers to the security questions you selected at registration. You will be able to choose a new password. If you have forgotten the answers to your security questions, you will need to send an email to: CSMD.ADMIN@tn.gov or call 615-253-1305.
6. What happens if I do not have a Tennessee driver’s license?
You can still register at www.tncsmd.com, but the process will require manual validation and approval by CSMD staff. This is applicable for individuals with driver’s licenses from other states and those without valid driver’s licenses or Tennessee issued ID cards.
7. I am already registered. Do I need to do anything else?
In order to assure you maintain access to the system you must always keep a unique active email address. Please be sure to update your account as needed by navigating to the “My Account” link after successfully logging in at www.tncsmd.com.
8. How do I register a delegate?
Delegates can register at www.tncsmd.com by providing their individual required information and their supervising practitioner’s driver’s license number to connect the delegate with the supervising practitioner.
9. Who is required to check the CSMD?
All healthcare practitioners are required to check before prescribing an opioid or benzodiazepine to a human patient as a new episode of treatment– and at least annually when said controlled substance remains a part of the treatment. A new episode of treatment means a prescription for a controlled substance that has not been prescribed by that healthcare practitioner within the previous twelve (12) months.
All healthcare practitioners are also required to check before dispensing an opioid or benzodiazepine to a human patient the first time at that practice site and at least once every twelve (12) months for that human patient after the initial dispensing.
However, healthcare practitioners are not required to check, pursuant to statute, if: (a) the controlled substance is prescribed or dispensed for a patient who is currently receiving hospice care; (b) the committee has determined that healthcare practitioners in a particular medical specialty do not have to check as a result of the low potential for abuse by patients receiving treatment in that medical specialty; (c) the quantity of the controlled substance which is prescribed or dispensed does not exceed an amount which is adequate for a single, seven-day treatment period and does not allow a refill; or (d) the controlled substance is prescribed for administration directly to a patient during the course of inpatient or residential treatment in a hospital or nursing home licensed under title 68.
Before prescribing or dispensing, a healthcare practitioner is also required to check the database if the healthcare practitioner is aware or reasonably certain that a person is attempting to obtain a Schedule II-V controlled substance, identified by the committee or commissioner as demonstrating a potential for abuse, for fraudulent, illegal, or medically inappropriate purposes, in violation of § 53-11-402.
An authorized healthcare practitioner’s delegate may check the database on behalf of the healthcare practitioner.
Note: It may be a good practice for healthcare practitioners to regularly check the database to arm themselves with sufficient information to guide their decisions concerning treatment plans, to keep abreast of their patients’ morphine milligram equivalents (MME) dosages, and to decrease the risk of adverse effects from prescribing.
Licensed veterinarians are not required to check the database before prescribing a controlled substance to a non-human patient.
10. When must I start using the database?
Healthcare practitioners who are required by law to register with the database must have done so by January 1, 2013 – and must check the database before prescribing or dispensing an opioid or benzodiazepine as set forth above.
New healthcare practitioners must register within 30 days of notification of licensure.
11. Who can register to access the databases?
A person licensed, registered, or otherwise permitted to prescribe, distribute, or dispense a controlled substance in the course of professional practice.
A certified registered nurse anesthetist (CRNA) as described in Section 63-7-103 of the Tennessee Code Annotated. Tennessee is one of the first states to allow direct access for CRNAs.
Healthcare practitioner delegates may register with the permission and supervision of a healthcare practitioner. Such individuals can include any person authorized to practice pursuant to title 63 and up to two other persons per healthcare practitioner.
Additionally, the law allows a number of other state and federal officials to register with the database including, certain law enforcement officers, medical examiners, drug court judges, and others. For more information regarding such registration please refer to the Prescription Safety Act.
12. What happens if a healthcare practitioner does not have electronic access to the database?
The law requires that each person or entity operating a practice site where a controlled substance is prescribed or dispensed to a human patient shall provide for electronic access to the database at all times when a healthcare practitioner provides healthcare services to a human patient potentially receiving a controlled substance. A violation of this requirement is punishable by a civil penalty not to exceed one hundred dollars per day assessed against the person or entity operating the practice site; the penalty shall only be imposed when there is a continued pattern or practice of not providing electronic access to the database.
13. How do I report that the system appears to be down?
Please send an email to CSMD.email@example.com with as much detail as possible about the issue and your best contact information.
14. Who serves on the CSMD Committee?
The committee members include:
One of the governor-appointed and licensed members of each of the following health care professional licensure boards or committees: medical examiners, osteopathic examination, dentistry, podiatric medical examiners, optometry, veterinary medical examiners, nursing, medical examiners’ committee for physician assistants, pharmacy.
One member of the Board of Pharmacy and one member of the Board of Medical Examiners who were appointed to those boards to represent the general public.
15. I am a healthcare practitioner. Can I see prescriptions that have been dispensed under my DEA number?
Yes. First, hover over the REQUEST tab on the upper navigation bar, and then choose “Practitioner Self-Lookup” from the list. A page will come up that has defaulted to your DEA. Choose the timeframe that you want to view and then click “View Report”. This will produce a report of all prescriptions dispensed and attributed to your DEA. You have the ability to export this report as a PDF to perform further review of the information. This report also allows you to generate a report for a specific patient for a specified time and see only the prescription you have written for that patient. Populate the patient information and choose “View Report” and you are able to save this report as PDF for further review.
If there are any prescriptions on your report that do not belong to you, please check with the pharmacy that dispensed the prescription so they can assess a potential forgery or correct any errors. Please allow thirty (30) days after requesting the pharmacy or other dispenser correct an error to allow the vender time to get the correction in the database. After thirty (30) days, you should notify the CSMD program if the error has not been corrected.
If after conversation with the pharmacy fraudulent activity is identified, please report any fraudulent patient activity to local law enforcement as necessary.
16. Does the CSMD contain a mechanism for me to compare my controlled substances prescribing against that of my peers?
Yes. Under the “Request” tab, click on “Practitioner v. Peer”. The system will default to the prior month, but you may change the time frame with the dropdown boxes. The system will show your rank out of those in the same specialty which you reported to the CSMD upon registration. This ranking is based on the total number of prescriptions during the chosen time period.
17. I am a supervising physician. How can I review prescriptions written by my supervisees?
From the “Practitioner Self-Lookup” page, there is a dropdown box which lists the prescribing supervisees associated with your account. From here, you may run a report on a selected supervisee.
18. How do I run a report to view the controlled substance history of a patient?
Once you are logged into the CSMD hover over the REQUEST tab on the top navigation bar. Then choose “New Request” and a page will appear that defaults to a PATIENT report. Fill in the patient’s LAST NAME, FIRST NAME, and DOB (date of birth). Scroll down the page and locate the Date Range. It defaults to the past year, but you can change that by clicking on the check mark in the box and entering the dates correctly (mm/dd/yyyy). You can search from 1/1/2010 until present. You must choose the type of report you want, either .PDF or .XLS. If you would like other state data, mark the appropriate checkbox and then click SUBMIT at the very bottom of the page.
The system will show you an indicator (a green spinning wheel or task bar) while it is searching the database. Multiple state data may take time to return if a user is authorized to view another state’s data. Once the taskbar disappears, a screen will come up with the “Patient Rx History Report” link in the middle of the page. Click on that link and the file can be Opened or Saved. If you run a multi-state report, please click the “Display all Results” button instead of the “Patient Rx History Report” hyperlink.
19. May I share information contained in the CSMD with a patient’s insurer?
Yes, as long as the information shared is contained in the patient’s medical record and the sharing is otherwise allowed under the law. The Prescription Safety Act of 2016 explicitly provides that CSMD reports may be placed in a medical record and that “[o]nce placed in a patient’s medical records, [a CSMD report] shall be subject to disclosure on the same terms and conditions as medical records.” Tenn. Code Ann. § 53-10-306(h)(4).
As such, under the Prescription Safety Act, it is legally permissible to share CSMD reports contained within a medical record as long as that sharing is in compliance with all other legal requirements.
20. Are there required steps of action if I suspect a patient is doctor shopping, based on a review of his or her records?
Yes, any physician, dentist, optometrist, veterinarian, pharmacist, advanced practice nurse with a certificate of fitness, or physician assistant who has actual knowledge that a person has knowingly, willfully and with intent to deceive obtained or attempted to obtain a controlled substance must report that information within five (5) business days to the local law enforcement agency. A reporting form is available at: http://tn.gov/assets/entities/health/attachments/PH-4152.pdf
Please call your nearest law enforcement agency and/or the Meth and Pharmaceutical Task Force at 423-752-1479 or fax the completed form to 423-267-8983.
Exception: Any physician, advanced practice nurse with a certificate of fitness, or physician assistant who has actual knowledge that a person has knowingly, willfully and with the intent to deceive obtained or attempted to obtain a controlled substance and who is providing treatment to a person with a mental health illness, may, but is not required to, report the information to law enforcement personnel.
21. What is required of healthcare practitioners who work in pain management practices under the new laws?
The Prescription Safety Act provides that any practitioner providing services at a registered pain management clinic who prescribes controlled substances for the treatment of chronic nonmalignant pain must document in the patient’s record the reason for prescribing or dispensing the quantity. Other requirements for pain management practices are included in the laws relating to pain management clinics. We suggest pain management practitioners review those provisions. Information regarding pain management clinics is on the Department’s website: http://tn.gov/health/topic/PM-board
22. May I review queries performed by my delegates?
Yes. To review queries performed by delegates, click on "Request" and then “View Request” and you will find a dropdown box listing all delegates/ extenders associated with your registration. Choose a delegate / extender and the time period you wish to review, and you may review all queries performed by that individual during the chosen time period.
23. Does the new legislation affect veterinarians?
Yes. While the requirements of the Prescription Safety Act are generally applicable to veterinarians, the Act provides that licensed veterinarians who never prescribe a controlled substance in an amount intended to treat a non-human patient for more than five (5) days are not required to register in the database. Licensed veterinarians are not required to check the database prior to prescribing an opioid or a benzodiazepine to a non-human patient. Moreover, licensed veterinarians are not required to report to the database drugs dispensed which are limited to an amount adequate to treat a non-human patient for a maximum of five (5) days.
24. Who monitors the prescription drug database and how is that monitoring conducted?
The monitoring is conducted by the Tennessee Department of Health staff and overseen by the CSMD Committee. The committee seeks to identify unusual patterns of prescribing and dispensing controlled substances that appear to be higher than normal, taking into account the particular specialty, circumstances, patient-type or location of the healthcare practitioners.
25. If I have general questions or technical issues with the database, how do I resolve them?
Contact the CSMD Administrator at 615-253-1305 or email the CSMD Administrator at CSMD.ADMIN@TN.GOV and the application provides help throughout the application. Look for the “?” on the page which may provide useful information.
26. What if healthcare practitioners choose to ignore the requirements of the law?
Failure to comply with the requirements of the CSMD laws may subject a licensee to discipline by the licensing board. Additionally, the Prescription Safety Act of 2016 allows for criminal penalties under certain circumstances.
27. If, after viewing information found in the CSMD, I believe that an investigation into a healthcare practitioner may be appropriate, how do I report that information to the Department of Health?
A complaint form is available by navigating to: http://tn.gov/assets/entities/health/attachments/PH-3466.pdf. The form should then be sent to the Office of Investigations for processing or to the Board of Pharmacy for a pharmacy complaint.
28. Will healthcare practitioners be able to find out what controlled substances might have been previously dispensed by out-of-state dispensers?
In many cases, yes. The Tennessee Department of Health is authorized to enter into agreements with other states or other entities acting on behalf of a state for the purposes of sharing and dissemination of data and information in the database as of January 1, 2013. As agreements are finalized users will have the option to view other states data by checking the appropriate boxes at the bottom of the patient request screen. At this time the Tennessee Department of Health has data sharing agreements with Alabama, Arkansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, North Dakota, South Carolina, Virginia and West Virginia.
Please note: incorporating additional states into the reports you generate may increase response time or in some cases a timeout as TN has no control of the response time from other states. Additionally, please be aware that each linked state has different laws regarding access to and the use of their prescription monitoring information.
29. Is a Veterans Administration or military prescriber required to check the database?
Any Veterans Administration or military prescriber who prescribes controlled substances and provides direct care to patients in Tennessee for more than 15 calendar days per year is required to register with the database as provided by the Prescription Safety Act of 2016. In the event that a provision of the PSA conflicts with a federal statute or regulation, then federal law shall apply.
To register go to http://www.tncsmd.com and choose the Practitioner user type if you have your own DEA number or if you practice under a facility DEA choose Veterans Affairs Practitioner and provide all of the required information.
30. Do I have to manually key my assigned login ID each time I login to the CSMD?
An individual user may choose to change their Internet Browser settings to allow their assigned login ID to be saved in the Browser Cookie. By choosing to save their assigned login ID in the Cookie, the "Username" field will automatically be populated with their assigned login ID. For assistance you should contact your Information Technology Department. Each user is responsible for maintaining the confidentiality of their username and password.
31. How do I notify the CSMD of my supervisory relationships?
Effective January 1, 2015, supervisory relationships contained in the CSMD will be used to populate a page associated with the provider profiles of supervisors and those under their supervision. Existing law obligates APRN’s, PA’s and physicians to notify the Department of Health of updates to their profiles within 30 days of the change. For APRN’s and PA’s, this requirement includes changes to their supervisory relationships.
APRN and PA users must identify all supervisors in the CSMD by entering the supervisors’ driver’s license numbers. All CSMD registrants were notified of this new requirement by email dated November 6, 2014. For current registrants, please click on “My Account” to update this information.
From the “My Account” Screen, scroll down to the “Supervisor Relationships” section. Existing supervisors already reported to the CSMD will appear and to add additional supervisors’ users may simply enter the driver’s license number and issuing state and click the “Add” button. Click “Save” at the bottom of the page to save the edits and the user will receive a message that the edit has been successfully entered.
For new supervisory relationships that involve a practice location not already in their “My Account” information, users will need to add in the details of the practice location and then may add the supervisor’s driver’s license number and issuing state. A popup box will appear with the practice locations associated with that supervisory registrant and the supervisee should select the appropriate location or locations and click “Add the Selected Provider”. This should return the user to the “My Account” screen. Click “Save” at the bottom of the page to save the edits and the user will receive a message that the edit has been successfully entered.
The supervising physician associated with that driver’s license number will be notified by email and also upon next logging into the CSMD that there are delegates awaiting approval. The supervising physician may then navigate to the “My Account” screen which will list all previously approved as well as pending delegate relationships. Click “Approve” to accept the supervisory relationship and the supervisory/ delegate relationship status will appear as “Active” for both the supervisor and the APRN or PA.
If the supervisory relationship agreement is terminated, the supervisor or the APRN/ PA may click “Revoke” on the “My Account” screen. Notification of changes to the supervisory relationship via the CSMD does not eliminate the requirement on the part of the APRN or PA to file a Notice and Formulary with the Board of Nursing as required by law.
Provided are instructions for adding Supervisory relationships in the CSMD.
32. If I have multiple supervisors, do I need to update my CSMD registration with the driver’s license number of every supervisor?
APRN’s and PA’s must report all supervisors who have supervision, control and responsibility for the prescriptive services of that APRN/ PA or for whom that APRN/ PA may be performing CSMD queries. The “My Account” screen allows you to add as many supervisors as necessary.
33. What happens if my supervisor does not have a driver’s license?
As referenced in Question #6 above, registration for users who do not have a driver’s license is completed manually by the CSMD Administrator who provides the registrant with an individual number that appears in the driver’s license number field. The supervisor may obtain that number from the “My Account” screen and that number should be provided to the supervisee.
34. When must I update my user account with my supervisor’s driver’s license number?
Users with supervisors should have updated their registrations by January 1, 2015.
35. How do I navigate between the CSMD and the data collection site?
If you dispense controlled substances and provide direct care to patients in Tennessee for more than 15 days per year, you must also register with the data collection site. There is a button on the right side of the menu bar that allows you to move easily from the CSMD to the data collection site for dispensers. Information regarding Data Collection is below.
DISPENSER DATA COLLECTION:
1. Who should register to report dispensations to the CSMD?
All healthcare practitioners, pharmacies, hospitals, and other institutions licensed, registered, or otherwise permitted to distribute, or dispense, controlled substances in the course of professional practice.
2. Do all dispensing reports have to be filed electronically?
Generally all dispensing reports should be filed electronically. However, if filing reports electronically presents an undue hardship, the committee may waive electronic reporting requirements for a period of up to two years. Click here to access the Request for Waiver Form http://tn.gov/assets/entities/health/attachments/PH-4138.pdf
In such instances, manual reporting is still required.
3. What are the requirements for reporting to the database, and are there any exceptions for reporting information to the database?
Any pharmacy, or licensed healthcare practitioner, who has a DEA number and dispenses controlled substances in (or into) Tennessee must report to the database daily (but no later than the close of business on the following business day) each controlled substance they have dispensed over the last twenty-four (24) hours. If a dispensing healthcare practitioner does not dispense any Schedule II-V prescriptions during a reporting period, a “zero report” must be submitted to the database. Please consult the Tennessee Controlled Substance Database Data Collection Manual for details.
Veterinarians are only required to submit prescriptions every fourteen (14) days.
Dispensers do not have to report if:
The drug is administered directly to a patient.
The drug is part of a narcotic treatment program (e.g., a methadone treatment program) registered by the United States Drug Enforcement Administration and is subject to the recordkeeping provision of 21 CFR 1304.24.
The drug is dispensed by a licensed healthcare facility, providing the quantity is limited to an amount adequate to treat the patient for a maximum of 48 hours.
The drug is a complimentary package of medicinal drugs that are labeled as a drug sample or complimentary drug dispersed to the practitioner’s own patients adequate to treat the patient for a maximum of forty-eight (48) hours in the regular course of practice without the payment of a fee or remuneration of any kind.
The drug is a sample of a schedule IV or schedule V controlled substance. In order to be exempt from reporting, a sample of a Schedule IV drug must be in a quantity limited to an amount that is adequate to treat a patient for a maximum of seventy-two (72) hours. In order to be exempt from reporting, a sample of a Schedule V drug must be in a quantity limited to an amount that is adequate to treat a patient for a maximum of fourteen (14) days.
The drug is dispensed by a licensed veterinarian, providing the quantity is limited to an amount adequate to treat the non-human patient for a maximum of five (5) days.
4. Why am I sometimes directed to call Appriss?
Appriss takes care of all prescription data uploads, so if you are a Pharmacy or a prescriber who dispenses controlled substances from your practice, you must upload your prescription information. If your problems deal with uploading data, please call Appriss at Phone: 1-866-683-9771 or Email: firstname.lastname@example.org. The upload center is at https://www.tnrxreport.com
5. If I am having trouble uploading my prescription data what should I do?
Appriss is under contract to provide customer support to help dispensers or prescribers who dispense resolve any technical issues with prescription uploading. Contact Appriss at Phone: 1-866-683-9771 or Email: email@example.com.
6. How can I be sure my file was uploaded successfully and accepted into the Tennessee Data Collection Portal?
Healthcare practitioners who dispense have an affirmative obligation to ensure their reports are accepted no matter the method in which those submissions are made.
You will receive automated notifications via email after your file has been processed. It is important you will visit your My Account page in the Data Collection Portal and ensure there is a unique active email address is in the profile and set your notification method to Email. After your file is processed, you'll receive an email providing information about your file upload and a link to the Data Collection Portal so you can correct any errors that have been identified in the file or record. A unique active email address for the account is critical to ensure that during TN’s migration in the future your user account can be migrated and will not require you to complete the registration process again.
If I don't want to provide an email or fax number for notification, how can I be sure my file was uploaded successfully and accepted into the Tennessee Data Collection Portal?
You can check the status of your file at any time by logging into the Data Collection Portal and selecting Data Center/File Upload. This page will list your uploaded files along with the file status and number of identified errors in the file or record. To correct the identified errors, you can click on the file name which will load the File Upload Errors page. Once the File Upload Errors page has loaded, you can click on the error description and you will be allowed to correct the data online. You can repeat this data correction scenario for each identified error. If email or fax information is not provided, that does not relieve responsibility of ensuring their submissions are accepted and in the future will cause the need for re-registration.
7. How do I upload data to the CSMD?
For dispensers or prescribing dispensers, information on uploading prescription data may be obtained from Appriss at 866-683-9771. Our data collection manual may be viewed and printed. You may also email Appriss for assistance with uploading data at TnRxReport@Appriss.com
NOTE: The above frequently asked questions and answers do not supersede the terms of the law governing the CSMD, but are merely provided as guidance for purposes of implementation and enforcement. They are a good faith effort by the Tennessee Department of Health (TDH) to be as transparent as possible in carrying out its regulatory role. The questions are informational in nature and do not constitute legal advice. Moreover, the questions and answers are subject to change. Those who are or may be subject to these laws are strongly urged to review the applicable laws and rules and seek their own legal counsel if necessary. Neither the TDH nor health-related boards are bound by this guidance in their interpretation of the law because each situation is unique. Medical and public health professionals were consulted in creating these FAQs, and the department thanks them for their role while acknowledging its sole responsibility for the FAQs.