New Law Tightens Regulations for Pain Clinics

September 8, 2016

In 2016, the Tennessee General Assembly passed Public Chapter 1033 related to office inspections and the licensure of pain management clinics. The intent of the law is to reduce the proliferation of “pill mills” that supply the prescription drug abuse epidemic in Tennessee by tightening up some perceived loopholes in the former pain clinic regulatory process. Specifically, the new law requires entities that meet the definition of “pain management clinic” (PMC) to be inspected and licensed by the state. Prior to passage of the law, such entities were only required to obtain a certificate and no prior inspection was required. It also allows the Department of Health (DoH) to conduct an unannounced inspection to determine if an office is operating as a pain management clinic without a license.

Unannounced Inspection
The DoH may conduct an unauthorized inspection to determine if a healthcare provider’s office is operating as a pain management clinic if specific evidence is present. The department may review business and medical records and require the production of evidence by the provider who has the onus to show that a majority of its patient population is not receiving chronic nonmalignant pain treatment. If it is determined that the office is operating as an unlicensed pain management clinic, it will be prohibited from admitting new patients to the practice. All clinic owners and providers operating an unlicensed pain management clinic will be subject to a hearing before the appropriate licensing board to determine whether or not the individual should have his or her license to practice revoked or be otherwise disciplined.  

A rule will be promulgated to set the requirements for the level of evidence that will be required in order to trigger an unannounced DoH inspection. TMA monitors all proposed rules and will solicit comments from affected members to submit to DoH.

Licensure of Pain Management Clinics
Currently, a practice that meets the definition of a PMC must obtain a certificate to operate from the DoH. Beginning July 1, 2017, the medical director must obtain a license for the PMC.  The license is valid for two years and expires on the last day of the month of the license period. The DoH will inspect each PMC before a license is issued and will inspect each clinic once every two years to ensure the clinic’s compliance with Tennessee law. 

The license shall be obtained by the medical director in the following manner:

 

  1. Submission of an application on a form supplied by DoH that includes the following information or statements:

    1. The medical director is of good moral character and able to comply with the minimum standards and rules for a PMC;

    2. Include the required fee;

    3. The name of the medical director and the name of any other PMC with which he/she is associated;

    4. The names and license numbers of any PMC employees or independent contractors providing services to the clinic;

    5. Whether any owner, employee or contractor has been convicted of any felony, under indictment for an offense involving the sale, diversion or dispensing of controlled substances under state or federal law, or if any license under which the person may prescribe, dispense, administer, supply or sell a controlled substance has been restricted, disciplined or denied; and

    6. Any other information the DoH may require.

The DoH’s timeline for the transition of a PMC’s certificate to a license is as follows:

 

  1. If a clinic’s certificate expires before July 1, 2017 and it plans to continue operating as a PMC:  Follow the current procedure for renewing a certificate. 

  2. If a clinic’s certificate expires after July 1, 2017 and it plans to continue operating as a PMC:  The new law states that current certificates shall be treated as licenses; therefore, it will have time to apply and receive a license before the expiration of the certificate. 

  3. Rules regarding the licensure process will be promulgated, but DoH could not provide an estimate of when the rules will be published. 

The Commissioner of Health may suspend the treatment of new or existing patients at a PMC if it is determined that the conditions of the clinic are, or are likely to be, detrimental to the health, safety or welfare of any patients.

An entity operating a PMC without a license commits a Class A misdemeanor. Each day of operation without a license constitutes a separate offense. 

A rule may be promulgated to set additional licensure or financial requirements. TMA monitors all proposed rules and will solicit comments from affected members to submit to DoH.

TMA will monitor the implementation of this law and publish additional articles in Member News as needed. If you have any questions, e-mail
legal@tnmed.org or call 800-659-1862, extension 1645.