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Pain Management Clinics

By John Williams
SPC Lobbyist

As a part of Tennessee’s effort to prevent prescription drug abuse, the General Assembly has imposed strict regulations on pain management clinics. In each legislative session since 2011, the legislature has “tightened the screws” on these clinics.

So what is the law now, and how did the legislature change it in 2016? How does the law define “pain management clinic”?

A “pain management clinic” is:

(8)(A) “Pain management clinic” means a privately-owned clinic, facility or office in which any health care provider licensed under this title provides chronic non-malignant pain treatment to a majority of its patients for ninety (90) days or more in a twelve-month period. For purposes of determining if a clinic, facility, or office qualifies as a pain management clinic under this subdivision (8)(A), the entire clinic, facility, or office caseload of patients who received medical care services from all medical doctors, osteopathic physicians, advanced practice nurses and physician assistants who serve in the clinic, facility of office shall be counted;
(B) “Pain management clinic” also means a privately-owned clinic, facility or office which advertises in any medium for pain management services of any type.
(C) A pain management clinic does not include any clinic, facility, or office which provides interventional pain management as defined in § 63-6-244 and whose clinic, facility or office does not provide a chronic non-malignant pain treatment to a majority of the patients of a clinic, facility or office for ninety (90) days or more in a twelve-month period;
(D) “Pain management clinic” does not mean a clinic, facility or office that is wholly owned and operated by a physician multispecialty practice in which one or more board-eligible or board-certified medical specialists who have also completed fellowships in pain medicine approved by the Accreditation Council for Graduate Medical Education, or who are also board-certified in pain medicine by the American Board of Pain Medicine or a board approved by the American Board of Medical Specialties, the American Association of Physician Specialists, or the American Osteopathic Association perform the pain management services for chronic pain patients;

To fully understand this definition, it is important to understand one of the terms used in the definition. “Chronic non-malignant pain treatment” is defined as follows:

(3) “Chronic non-malignant pain treatment” means prescribing or dispensing opioids, benzodiazepines, barbiturates or carisoprodol for ninety (90) days or more in a twelve-month period for pain unrelated to cancer or palliative care;

So the definition of a “pain management clinic” is tied to the prescribing of certain types of drugs used to control pain to a majority of the clinic’s patients.

Under current law every pain management clinic must hold a certificate issued by the Tennessee Department of Health. The person to whom the certificate is issued must be one of the owners of the clinic. Only the following health care providers may hold an ownership interest in a pain management clinic -- medical doctors, osteopathic physicians, advanced practice nurses, and physician assistants.

If a person owns more than one pain management clinic, the person must hold a separate certificate for each clinic location. Each clinic must renew its certificate every other year.

Every pain management clinic must have a medical director, who is a MD or DO with an unrestricted, unencumbered license. The medical director provides oversight relative to the operations of the clinic, must be on-site at the clinic at least 20% of the clinic’s total weekly operating hours, and may not provide medical director services for more than 4 pain management clinics.

Beginning July 1, 2016, the medical director must be a “pain management specialist,” defined as:

(9) “Pain management specialist” means a physician licensed under chapter 6 or 9 of this title who:

(A)(i) Has a subspecialty certification in pain medicine as accredited by the Accreditation Council for Graduate Medical Education (ACGME) through either the American Board of Medical Specialties (ABMS) or the American Osteopathic Association (AOA), or is eligible to sit for the board examination offered by ABMS or AOA;
(ii) Holds an unencumbered Tennessee license; and
(iii) Maintains the minimum number of continuing medical education (CME) hours in pain management to satisfy retention of ABMS or AOA certification. Any exceptions to this requirement shall be approved by the respective regulatory board;
(B)(i) Attains American Board of Pain Medicine (ABPM) diplomate status;
(ii) Holds an unencumbered Tennessee license; and
(iii) Maintains the minimum number of CME hours in pain management to satisfy retention of ABPM diplomate status. Any exceptions to this requirement shall be approved by the respective regulatory board;
(C) Is board certified by the American Board of Interventional Pain Physicians (ABIPP) by passing exam 1, and holds an unencumbered Tennessee license and maintains the minimum number of CME hours in pain management to satisfy retention of ABIPP diplomate status; or
(D) Has an active pain management practice in a clinic accredited in outpatient interdisciplinary pain rehabilitation by the commission on accreditation of rehabilitation facilities or any successor organization and holds an unencumbered Tennessee license.

All APNs and PAs who practice in a pain management clinic must be supervised by a pain management specialist.

Beginning July 1, 2017, the medical director of a pain management clinic must obtain a license from the Tennessee Department of Health for the clinic. Licensure will replace certification as the documentation that a clinic must obtain to operate legally. The license will be issued to the medical director rather than to one of the clinic’s owners (although the medical director may be an owner of the clinic). The license must be renewed every two years.

Chapter 1033 of the Public Acts of 2016, adopted by the General Assembly in 2016 but not effective until July 1, 2017, places a great emphasis on inspections by the Department’s Office of Investigations. Each pain management clinic will be inspected at least once every two years. Furthermore, when the Department has a “reasonable suspicion” that a health care provider’s office meets the definition of a “pain management clinic” but is not licensed as such, the Department may conduct an unannounced inspection of the business and medical records of the office to determine whether it should be licensed. If the office is not able to provide satisfactory evidence that it does not meet the definition of a “pain management clinic,” the office shall be prohibited from accepting new patients until it is properly licensed.

Chapter 1033 prohibits an owner of a pain management clinic from participating in the location of a pharmacy that would be adjacent to the location of the clinic.

The medical director of a pain management clinic will be required to file an annual report with the Department, reporting such information as the number of patients, the number of health care providers, whether the clinic is associated with a hospital, etc.

Chapter 1033 prescribes some very stringent civil and criminal penalties for violation of the law, as well as revocation of a clinic’s license.

With one very limited exception, a provider working at a pain management clinic may not dispense any controlled substance.

There are other provisions of the law (and rules adopted by the Department) which are not covered in this article.