TBA Law Blog

Posted by: Lynn Pointer on Sep 19, 2012

By Angela Youngberg

Angela Youngberg

A Tennessee law requiring "pain management clinics" to register with the Department of Health became effective on January 1, 2012.  Tenn. Code Ann. §§ 63-1-301 et seq.  A 2012 amendment to the statute provides that pain management clinics operating before January 1, 2012 may continue to operate as long as an application for certification is filed before October 1, 2012.  Due to some lack of clarity in drafting, however, the new law applies to more than just traditional pain clinics.  It can apply to any medical clinic that prescribes pain medications, benzodiazepines, and certain other controlled substances for more than 90 days in a year to more than 50% of its patients.  Department of Health regulations provide for fines of up to $1,000 per violation, per day.  As a result of this new law, many clinics are choosing to refer their pain patients to certified pain management clinics.

The law and accompanying Department of Health (the "Department") regulations define a "pain management clinic" ("PMC") as any privately-owned facility in which: (i) an M.D., D.O., N.P. or P.A. evaluates, diagnoses or treats for the prevention, reduction or cessation of pain symptoms through pharmacological, non-pharmacological or other means and (ii) a majority of the facility's patients are issued prescriptions for, or are dispensed, opioids, benzodiazepine, barbiturates or carisoprodol (but not suboxone) for more than 90 days, whether consecutive or not, over a twelve month period.  However, PMCs do not include hospitals, hospice care, nursing homes, governmental facilities or most professional schools.  Similarly, the Department has clarified that the provision of pain management services does not include the treatment of malignant conditions in an oncological setting or the use of benzodiazepines for the treatment of mental health conditions.

Facilities falling under the PMC definition must now obtain a certificate from the Department by submitting an application that requires detailed information about the clinic and its providers and $415 in total fees.  The certification must be renewed every two years.  Also, no one that has been convicted of a felony or a misdemeanor related to the distribution of illegal prescription drugs or a controlled substance may possess an ownership interest in a PMC.

In addition, Department regulations include new requirements for PMC medical directors.  Each PMC must have a medical director who is a physician with an unrestricted and unencumbered Tennessee medical license.  Moreover, the director must satisfy at least one of the enumerated educational requirements identified in the Department regulations.  The director's responsibilities include oversight of all the pain management services at the PMC; being on-site at least 20% of the PMC's operating hours; and establishing policies and procedures in compliance with Department regulations.  Additionally, the director must ensure that all healthcare providers working at the PMC comply with applicable state and federal regulations related to prescribing controlled substances and must ensure that all supervising physicians comply with applicable NP and PA supervision requirements.

The new law also grants to the Department substantial oversight authority over PMCs.  For example, the Department may conduct at-will inspections of all PMCs and may investigate complaints against PMCs for alleged violations of the new law.  PMCs must grant the Department full access to all facility records, including medical records.  Finally, the Department may impose fines of up to $1,000 per incident, per day against PMCs in violation of applicable statutes or regulations and may take disciplinary action against the PMC's providers.