Tennessee Pain Management Clinic Registry

Pursuant to Tennessee Code Annotated (“T.C.A.”) § 63-1-301, a “pain management clinic” is defined as a privately-owned clinic, facility or office in which any health care provider licensed under Title 63 provides “chronic nonmalignant pain treatment,” meaning the prescribing of opioids, benzodiazepines, barbiturates, or carisoprodol for ninety (90) days or more in a twelve- month period, unrelated to cancer or palliative care, to a majority of its patients. For purposes of determining if a clinic should be licensed under this part, the entire clinic, facility, or office caseload of patients who received medical services from all medical doctors, osteopathic physicians, advanced practice registered nurses and physician assistants who serve in the clinic, facility or office shall be counted.

“Pain management clinic” shall also mean any privately-owned, facility or office which advertises in any medium for any type of pain management services. Pursuant to T.C.A. § 63-1-301, all pain management clinics in Tennessee must be licensed by the Tennessee Department of Health (the “Department”).

The following FAQ responses and statements do not supersede the terms of the Tennessee Code or the relevant rules and regulations, and are merely provided as guidance. They are provided in a good faith effort at transparency in the Department’s regulatory role. The questions are informational in nature and do not constitute legal advice. Moreover, the questions and answers are subject to change, and the Department is not bound by this particular guidance in its interpretation of the law.

Answer: No. Treatment with one of the named substances for ninety (90) days within a twelve-month period, whether consecutive or not, rises to the level of prescribing outlined in T.C.A. § 63-1-301 et seq.

Answer: Possibly. T.C.A. § 63-1-302 provides some exemptions from the requirement to obtain pain management clinic licensure, primarily for health care facilities otherwise inspected pursuant to T.C.A. Title 68. The Department encourages practitioners to seek guidance from private and/or in-house legal counsel as to whether their clinic qualifies for exemption under T.C.A. § 63-1-302.

Answer: T.C.A. § 63-1-311 provides that each practitioner providing pain management services, as well as anyone who owns or operates an unlicensed pain management clinic, is subject to an administrative penalty of not less than $1,000 and not more than $5,000 per day.

Answer: No. T.C.A. § 63-1-316(f) requires that each clinic location be licensed separately, regardless of whether that clinic is operated under the same name, ownership, or management as another clinic. It is not possible under the law to change the location or address of a clinic’s license. Thus, a pain management clinic that moves from its original location, even if it is relocating nearby, is treated as a completely separate and new clinic under the law. If you operate a licensed pain management clinic and intend to open another clinic at a different location, you must first submit a separate application for the new location and obtain a new license prior to operating at the new location, regardless of whether or not you intend to continue to operate a clinic at the original location.

Answer: No. Tenn. Comp. R. & Regs. 1200-34-01-.09(3) does not require a new applicationto be filed in order to change the name of a clinic. Rather, it requires the Medical Directorto notify the Department within ten (10) business days after the name change occurs. Thisnotification may be accomplished by emailing the Administrative Office.

Answer: No. A medical director must be on-site for at least 20% of the clinic’s weekly operating hours. A schedule in which the medical director is only on-site 20% of the hours every month or every other week will not meet this requirement.

Answer: The medical director must be physically present on-site for 20% of the operating hours for each location. T.C.A. § 63-1-309(c) requires the medical director to be on-site a minimum of 20% of each clinic’s weekly total operating hours. Additionally, a medical director may not provide services at more than four (4) pain management clinics.

Answer: No. Only one individual can be licensed as a pain management clinic’s medical director at any one time. Rule 1200-34-01-.10(1)(a)6 requires that the clinic’s medical director identify a pain management specialist who has agreed to provide coverage in the event the medical director is unable to fulfill his or her duties on a temporary basis. This coverage may only be provided on a temporary, short-term basis and will not count against the four-clinic limit at which one can serve as a medical director. If the medical director will not be able to return, then pursuant to Rule 1200-34-01-.09, your clinic must notify the Department of the identity of the new qualified interim medical director within 10 business days using the Department’s Pain Management Clinic Notice of Appointment of Interim Medical Director form. You must also include documentation that she or he is a pain management specialist. The clinic may operate under the direction of the interim medical director for a grace period of up to 30 calendar days, during which time the new, permanent medical director must immediately submit a completed initial license application for a new pain management clinic license at the clinic’s location. If the new application is not completed and approved by the end of this 30 calendar day grace period, then the clinic must cease operations. Should the clinic have difficulty obtaining a new medical director, it may apply for a waiver of up to an additional sixty (60) calendar days in which to operate with the Interim Medical Director. The waiver will only be granted upon good cause shown, demonstrated reasonable efforts to locate and retain a new medical director, and a reasonable belief by the Department that public health will be harmed by not granting the waiver. Both the pain management clinic license and the Interim Medical Director are liable for any actions or inactions occurring at or caused by the pain management clinic during any granted grace period.

Answer: No. Tenn. Comp. R. & Regs. 1200-34-01-.10(1)(a)6 provides that such temporary, short-term coverage service does not count against the limit of four pain management clinics at which a medical director can serve.

Answer: Yes. When providing coverage for a clinic’s primary medical director, the covering medical director must be on site at the clinic for at least 20% of the weekly operating hours during the entire period of coverage. It is the primary medical director’s responsibility to ensure that the coverage medical director is available for the required hours. The primary medical director may be subject to discipline for the coverage medical director’s failure to meet the minimum on-site hours.

Answer: Before you begin operating as a pain management clinic, please see T.C.A. §63-1-301(8), which defines a pain management specialist as a Tennessee-licensed physician with an unencumbered license who has obtained accreditation and training along one of four recognized pathways. A pain management clinic cannot operate in Tennessee without a medical director who has met this requirement.

Answer: No. Pursuant to T.C.A. § 63-1-301(4)(c), after July 1, 2016, a physician must meet the definition of a pain management specialist to be qualified as a medical director. In order for your pain management clinic to operate legally, you will need to find and employ a physician who already meets all the statutory requirements. Additionally, all collaborating and supervising physicians of advanced practice registered nurses and physician assistants must also be pain management specialists. The Department may approve a medical director who “is eligible to sit for the board examination offered by ABMS or AOA” under T.C.A. § 63-1-301(8)(A). The Department considers proof of registration to sit for an examination to be evidence of eligibility. The Department may later request verification of the medical director’s examination results.

Answer: No. Medical licenses in Tennessee are issued by profession and not by specialty. The Department evaluates each applicant’s qualifications at the time of application and does not maintain a separate list of physicians qualified as pain management specialists.

Answer: No. The use of benzodiazepines for treatment of mental health conditions (such as anxiety or depression) and not for pain management does not fall within the scope ofT.C.A. § 63-1-301(2), which specifically references “Chronic non-malignant pain treatment” services in the definition of “pain management clinic.”

Answer: No. T.C.A. §53-11-311 permits the prescription of buprenorphine products only for patients undergoing opiate withdrawal treatment or for other FDA-approved purposes. Suboxone and buprenorphine are opioids and, if used in any form for the purpose of pain management, must be counted when determining whether a clinic requires registration as a pain clinic. However, if, and only if, these drugs are used in accordance with their FDA indication solely in the context of a bona fide program for Medication-Assisted Treatment (“MAT”) for opioid dependence, this would not be considered pain management services, and those patients should not be counted as such. Finally, note that if a significant amount of your patient population is receiving MAT, your practice may need to register as a nonresidential office-based opiate treatment facility (“OBOT”), as defined at T.C.A. § 33- 2-402, with the Tennessee Department of Mental Health and Substance Abuse Services. Licensing procedures for OBOTs can be found at Tenn. Comp. R. and Regs. 0940-05-35-.04.

Answer: No. T.C.A. § 63-1-301(2) defines chronic non-malignant pain treatment to be treatment for pain unrelated to cancer or palliative care.

Answer: Yes. Tramadol, which works on the brain’s opioid receptors and is a Schedule IV controlled substance, has an approximate morphine equivalent dose value of 0.1 and should be considered in assessing whether a provider must register as a pain management clinic.

Answer: Yes. Codeine has an approximate morphine equivalent dose value of 0.15, is a Schedule II controlled substance, and should be considered in assessing whether a provider must register as a pain management clinic.

Answer: Only as a co-pay when a patient is paying through insurance. T.C.A. § 63-1-310 specifically limits acceptable forms of payment for pain management clinics to checks or credit cards except that clinics may accept cash for a co-pay, coinsurance, or deductible when the remainder of the charge is submitted to the patient’s insurance plan for reimbursement.

Answer: Yes. Any clinic, facility, or office which holds a pain management clinic license is subject to the pain management clinic laws for as long as it holds that license, regardless of whether that clinic, facility, or office still meets the definition of a pain management clinic. Tenn. Comp. R. and Regs. 1200-34-01-.07 allows a pain management clinic to voluntarily inactivate its license via an inactivation form issued by the Department, but unless and until the license is inactivated, your clinic must comply with all pain clinic laws and rules.

Answer: Under the current law, a pain management clinic license in Tennessee is granted to and held by the clinic’s Medical Director.

Answer: T.C.A. § 63-1-316(h) mandates that owners of pain management clinics may not locate or participate in locating a pharmacy in which any owner of the pain management clinic has an ownership interest adjacent to the clinic. Tenn. Comp. R. and Regs. 1200-34- 01-.01(2) defines “Adjacent” as “within 1,000 feet.” Violation of this law is grounds for revocation of the pain management clinic license.

Answer: In addition to any other continuing education requirement to maintain licensure under Title 63, Tenn. Comp. R. & Regs. Rule 1200-34-01-.11(2) requires that any practitioner providing services at a pain management clinic complete at least ten (10) hours of continuing education courses during their licensure renewal cycle in a topic related to pain medicine. Those topics are:

(a) Prescribing controlled substances;

(b) Drug screening or testing;

(c) Pharmacological and non-pharmacological pain management;

(d) Completing a pain management focused history and physical examination and maintaining appropriate progress notes;

(e) Comorbidities with pain syndromes; and

(f) Substance abuse and misuse including diversion, prevention of same, and risk assessment for abuse.

In addition, the clinic’s medical director must obtain the continuing education required to maintain certification, accreditation, and/or diplomate status in his or her pain management board or association to continue to qualify as a pain management specialist. All medical directors and collaborating or supervising physicians of advanced practice registered nurses or physician assistants working in the clinic must also obtain the continuing education required to maintain medical license specific by their governing boards.

Answer: The application is available online here.

Answer: $1.500.00, as set forth in Rule 1200-34-01-.06(1), plus the $10 state regulatory fee.

Answer: The inspection fee is $1,500.00, as set forth in Rule 1200-34-01-.06(4). Pursuant to Rule 1200-34-01-.08, a clinic’s initial inspection fee is due at the time of license application. For new licensees, the inspection shall be conducted within 90 business days of the Department’s determination that an application is complete. If a clinic does not pass its initial inspection, the Department, at its discretion, may re-inspect the clinic subject to a $1,000.00 re-inspection fee. Once a clinic is licensed, the department shall conduct biennial random inspections. The standard $1,500.00 inspection fee is due 30 days following each biennial inspection. Where an inspection uncovers possible violations or deficiencies, the Department may require a reinspection. The reinspection fee is $1,000.00.

Answer: No. Under T.C.A. § 63-1-316(f), a pain management clinic license is neither assignable nor transferable once granted. However, under Tenn. Comp. R. and Regs. 1200- 34-01-.09(1), a clinic may continue to operate under the previous medical director’s pain management clinic license for up to a thirty (30) day grace period, provided that the clinic informs the Department of its interim medical director on the prescribed form within ten(10) business days of the date the current medical director no longer qualifies to serve as a Medical Director or departs the Clinic. You will also need to submit copies of the Interim Director’s Pain Specialist Certificate and DEA license. During this grace period, a new, permanent medical director must immediately submit a completed initial license application for a new pain management clinic license for that location. If a new license is not issued under the new medical director’s name by the end of the grace period, then the clinic will be required to cease operations until the Department issues the new license. In addition, both the pain management clinic license and the Interim Medical Director are liable for any actions occurring at the pain management clinic during this time. Additionally, should the current medical director inactivate the clinic’s license, the clinic must immediately cease operation. Prior to inactivating the license, the Medical Director shall have the responsibility to notify all patients receiving care at the clinic and arrange for continuity of care.

Answer: Under Tenn. Comp. R. & Regs. Rule 1200-34-01-.09(1)(g), if the clinic cannot find a new, permanent medical director during the grace period, the interim may apply for a pain management clinic license to be issued for a term of six (6) months.

Answer: No. If you submit an application for licensure which is deemed completed ninety days prior to your license’s expiration date, and your licensure application is for the same location as your license, but the Department does not inspect your clinic prior to the license’s expiration, you may continue operation. The Department may issue you a license and conduct the initial inspection after you are licensed.

Answer: The annual report is due to the Department sixty (60) days prior to the pain management clinic’s license anniversary date and shall cover the previous twelve (12) months. For example, if the clinic’s license anniversary date and/or expiration date is June 30th, then the annual report is due on May 1st and must cover the 12-month period beginning in May of the previous year. You can use the chart below to ensure an accurate time period After submitting your Annual Report, please be sure to email PainManagement.Health@tn.gov and attach each new provider’s DEA and supervisory forms. You will also need to conduct a background check via IdentGo using OCA 3333, if the provider has not had one done in the last 365 days. You are also required to update your LARS and CSMD relations with the new providers as delegates. Keep in mind that the Annual Report is a part of your clinic renewal application. You may submit the Annual Report online using the web form available here.

Answer: The annual report from the medical director must list all owners and theirpercentage of interest in the clinic for each month of the preceding year. Additionally, onthe renewal application, the medical director will have to attest that no owner has beenconvicted or, pleaded nolo contendere to, or received deferred adjudication for any felonyor misdemeanor relating to the distribution of illegal prescription drugs or a controlledsubstance. Failure to disclose the requested information could result in disciplinary actionagainst the pain management clinic license as well as the individual licenses of the medicaldirector and the owner.

Answer: No. The medical director, anyone with ownership interest, and each person whoholds a DEA registration who will be providing services at the clinic must always submit acriminal background check as part of the licensure application process. Sometimes othersmust as well. Criminal background checks must also be submitted for any person workingin the clinic—as an employee or contractor—who has clinical contact with patients; or whohas contact with onsite patient information or specimens; or who has managementresponsibilities; and who has been convicted of a felony; or who is under indictment for anoffence involving the sale, diversion, or dispensing of controlled substances; or who hasever been convicted of an offense involving the sale, diversion, or dispensing of controlledsubstances. It is the medical director’s responsibility to make an appropriate inquiryregarding whether he or she needs to submit an employee or contractor’s criminalbackground check. The Department has promulgated a form on the pain management clinic website to help facilitate medical directors in conducting this inquiry. All background checks must be completed through the State’s approved vendor IdentGo, Background checks must have OCA code 3333 and are valid for 365 days.

Answer: IdentoGo cannot reuse previous fingerprints. It may be possible to request accommodation. Any decision in this regard, however, will be determined by the entity or entities responsible for fingerprinting and/or conducting the background check. Please notify the Administrative Office immediately of the need to request an accommodation.

Answer: No. A clinic’s license will expire every two years. As part of the renewal process you will have to make several attestations that the owners, employees, and contractors working in your clinic don’t have criminal backgrounds as outlined in the rules. This includes an attestation that no person working in the clinic—as an employee or contractor— who has clinical contact with patients, contact with onsite patient information or specimens, or who has management responsibilities, has been convicted of a felony, or is under indictment for an offense involving the sale, diversion, or dispensing of controlled substances, or has ever been convicted of an offense involving the sale, diversion, or dispensing of controlled substances. If anyone meets this criteria, then the Department may require that person’s criminal background check be submitted with the renewal application.

Answer: The Department recognizes that the need for an initial licensure inspection in the process of moving locations can raise concerns regarding patient continuity of care. Therefore, if a clinic wishes to move locations, it may arrange with the Department to have its current pain management clinic inspected prior to moving. Should the pain clinic pass inspection and be otherwise qualified for licensure, the Department may issue a license to the new location. The new location will then be inspected after the license is issued, allowing the clinic more freedom to determine when its move will occur. The Department will charge a reinspection fee for the inspection of the new clinic location once the move does occur.

Answer: No. Tenn. Comp. R. & Regs. Rule 1200-34-01-.09(1)(a) states:

“The clinic may continue to operate on the current Medical Director’s license for a grace period of up to thirty (30) calendar days from the date that the current Medical Director no longer met the requirements contained in T.C.A. §§ 63-1-301, et seq. and these rules to be a Medical Director, or the date the current Medical Director departs the clinic, provided the clinic notifies the Department, on a form prescribed by the Department, within ten (10) business days of the identity of another pain management specialist who will serve as the interim Medical Director for the clinic.”

An interim medical director is operating on the previous medical director’s clinic license until a new clinic license is granted. The 30-day grace period for an interim medical director (or 60-day waiver extension) will not extend the expiration date of the clinic license. Thus, if the previous medical director’s clinic license reaches its expiration date before a new clinic license is issued to the new medical director, the clinic must cease operations. In order to avoid an interruption in patient care, if your clinic license is within 90 days of its expiration date, you may wish to have the previous medical director renew the clinic license before you file a Notice of Interim Medical Director.

Answer: No. A 60-day waiver extension request is only available one time and only to clinics who meet the requirements listed in Rule 1200-34-01-.09(1)(d). Once the additional 60-day waiver expires, then the clinic must cease operations unless or until the new medical director license has been issued in accordance with Rule 1200-34-01-.09(1)(e).

Answer: Once a completed application is submitted to the Office of Investigations for inspection, the Department has 90 business days to complete the inspection. The Administrative Office is not involved in the inspection process and cannot answer any questions regarding inspections, including the scheduling of inspections. Inspections will be conducted in the order the applications are submitted. A pain management clinic may not open until the clinic is inspected, the inspection is approved, and a license is issued. Once approved, you will be notified by letter, and your license will be issued. In some cases, it may take longer to receive the actual license certificate; however, a clinic may begin operations once the approval notification letter is received.