Controlled Substance Monitoring Database (CSMD) and Prescription Safety Act
The Tennessee Prescription Safety Act of 2012, Tenn. Pub. Acts, ch. 880, 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 May 9.
In accordance with the Controlled Substance Monitoring Act of 2002, the Tennessee Department of Health established a database to monitor the dispensing of Schedule II, III, and IV & V controlled substances. Data collection began for all dispensers on December 1, 2006. The 2012 Act enhances the monitoring capabilities of the database.
All prescribers with DEA numbers who prescribe controlled substances and dispensers in practice providing direct care to patients in Tennessee for more than (15) calendar days per year shall be registered in the controlled substance monitoring database by January 1, 2013. Licensed veterinarians who never prescribe a controlled substance in an amount intended to treat a non-human patient for more than 48 hours are not required to register.
Health care 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 controlled substance monitoring database.
The law permits practitioners to designate health care extenders to check the CSMD. The extenders must act under the supervision of a licensed prescriber or dispenser.
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; please follow the actual provisions of the law, included at the end of this section in its entirety.
You must be registered 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 prescribers) or licensure (for dispensers.)
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.
“If you provide direct care and prescribe controlled substances to patients in Tennessee for more than 15 days per year or you are a dispenser in practice providing direct care to patients in Tennessee for more than 15 days per year, you are required to register with the CSMD.” However, if you do not practice in Tennessee or hold a Tennessee license, you are not required to register for access to the CSMD.
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:
Yes, but he/she will need to have access to all the information required. You must also be able to recall all information used to establish the account.
The website allows ups to five attempts to enter the correct password and offers reminders about case sensitivity and the combination of characters required. If you are still unable to log in, you may select Forgot/Reset Password and answer security questions you provided at registration. Your password will then be reset and a temporary password will be sent via email. 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.
You still register at www.tncsmd.com , but the process will be manual (it is not validated via technology, but the CSMD Administrator will validate your information)
You may be asked to verify/revise your confidential and private email, choose your specialization and enter your driver’s license number. Once this is entered, you will be able to continue into the CSMD.
As of January 1, 2013 designated extenders can register at www.tncsmd.com and will need specific information from their supervising practitioners.
You will need to update your profile by navigating to the “My Account” link after successfully logging in at www.tnscmd.com.
Any licensed prescriber before prescribing an opioid or benzodiazepine to a human patient as a new course of treatment lasting more than seven days – and at least annually when said controlled substance remains a part of the treatment. However, prescribers are not required to check if: (a) the controlled substance is prescribed or dispensed for a patient who is currently receiving hospice care; (b) the committee has determined that prescribers 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 controlled substance is prescribed or dispensed to a patient as a non-refillable prescription as part of treatment for a surgical procedure that occurred in a licensed healthcare facility; (d) 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. Licensed veterinarians are not required to check the database before prescribing an opioid or a benzodiazepine to a non-human patient.
Any pharmacy, or licensed healthcare practitioner, who has a DEA number and dispenses controlled substances in (or into) Tennessee must report to the database every seven (7) days for each controlled substance they have dispensed over the last seven (7) days. Dispensers must report daily beginning on January 1, 2016.
Dispensers do not have to report if:
We encourage prescribers and dispensers to register and begin use as soon as possible. The law, however, specifies some key dates:
There is a button on the right side of the menu bar that allows you to move easily from CSMD to data collection site for dispensers.
A licensed or registered health care professional designated by the prescriber or dispenser and up to two (2) non-licensed staff members can access 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 prescriber or dispenser 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.
Please send an email to CSMD.email@example.com.
The committee members include:
Yes. First, click on REQUEST 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 attributed to your DEA dispensed by pharmacies. 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 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 correct any errors.
If after conversation with the pharmacy fraudulent activity is identified, please report any fraudulent patient activity to local law enforcement as necessary.
Once you are logged into the Controlled Substance Monitoring Database, click on REQUESTS 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. If you need information from the database from 01/01/2007 through 12/31/2009 please send an email request to CSMD.Admin@tn.gov. You must click on the AUTHORIZE paragraph, and then 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 a green 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.
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://health.state.tn.us/Downloads/Report_to_Law_Enforcement.pdf. Please call your nearest law enforcement agency and/or the Meth and Pharmaceutical Task Force at 423-752-1479 to obtain the appropriate fax number.
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.
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://health.state.tn.us/Boards/PainClinicRegistry.shtml
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 forty-eight (48) hours 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 forty-eight (48) hours.
The monitoring is conducted by the Tennessee Department of Health staff and overseen by the Controlled Substance Monitoring Database 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 prescriber or dispenser.
Please note the provisions for prescribers and dispensers:
For prescribers: If the committee determines a prescriber has a difficult to understand or an unusually high pattern of prescribing/dispensing controlled substances, taking into account the particular specialty, circumstances, patient-type or location of the prescriber, the committee will request more information to better understand the facts in the context of the prescriber’s clinical practice. After receiving the information, if the committee’s concerns are resolved, then the issue will be deemed closed. However, in some instances, a formal investigation by health licensure and regulation staff may be warranted. An investigation itself does not imply any violation or wrongdoing, only that additional diligence is required to resolve or advance the question.
For dispensers: If the committee has questions about dispensing patterns of a pharmacy, it will notify the chief investigator for the Board of Pharmacy. The chief investigator may initiate fact finding or a formal investigation as needed, looking at dispensing patterns of the pharmacist or pharmacists conducting business at that pharmacy. Similarly, prescribers who also dispense controlled substances will be subject to the same process through the appropriate regulatory board.
No. 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://health.state.tn.us/boards/Controlledsubstance/PDFs/PH-4138.pdf. However manual reporting is still required.
Contact the CSMD Administrator at 615-253-1305 or email the CSMD Administrator at CSMD.ADMIN@TN.GOV
Failure to comply with the requirements of the Controlled Substance Monitoring Database laws may subject a licensee to discipline by the licensing board.
A complaint form is available by navigating to: http://health.state.tn.us/boards/PDFs/PH-3466.pdf. The form should then be sent to the Office of Investigations for processing of a prescriber or clinic complaint or the Board of Pharmacy for a pharmacy complaint.
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. Please note: incorporating additional states may reduce response time.
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 2012 (“PSA”). 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 www.tncsmd.com and choose Practitioner if you have your own DEA number or if you practice under a facility DEA choose Resident/Fellow or Veterans Affairs Practitioner and provide all of the required information.
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.
PHARMACY DATA COLLECTION:
Optimum Technology 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 Optimum Technology at Phone: 1-866-683-9771 or Email: firstname.lastname@example.org. The upload center is at https://tnrxreport.com
Optimum Technology is under contract to provide customer support to help you resolve any technical issues with your prescription uploading. Contact Optimum Technology at Phone: 1-866-683-9771 or Email: email@example.com.
You can receive automated notifications via email after your file has been processed. To activate this, you will need to visit your My Account page in the Data Collection Portal and set your notification method to Email and provide your email address. 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 occurred.
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 errors. To correct the 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 error.
NOTE: The above frequently asked questions and answers do not supersede the terms of the law governing the Controlled Substance Monitoring Database, 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.