Pain clinic definitions in the medical literature and U.S. state laws: an integrative systematic review and comparison

The literature on pain clinic definitions very much stems from these papers which were published in 1990 and 1991. Early searches which did not include these time parameters yielded few useful results, although a paper published before this date (Bonica 1977) was added to our final analysis based on expert input. Also, no state pain clinic regulations preceded the date of these seminal papers.

PDFs that were not readily available at our institution were submitted to our interlibrary loan service. Several of these came back as irretrievable from library staff while several others were simply not retrieved without notification from staff. Often these articles are irretrievable if they cannot be located in English, although the source is originally identified as English. Additionally, given that our search included “grey” literature, we expected some irregularities in the search and retrieval process of that literature.

We excluded state regulations of individual providers who treat chronic pain from review of pain clinic laws, as the two types of laws differ in scope and content. Additionally, some states regulate individual prescribers but not pain clinics. Regulations of individual providers focus on prescribers of opioids for chronic pain. These regulations capture a very broad swath of providers, as they are applicable any time a provider prescribes opioids for chronic pain, regardless provider specialty. On the other hand, pain clinic regulations are much narrower, typically only applying to entities that market themselves as treating pain, that frequently prescribe controlled substances for pain, or that have a majority of patients treated for pain. Second, the content of state regulations of individual providers differs from that of pain clinic regulations. Pain clinic regulations require separate registration for pain clinics without which the pain clinic cannot legally operate, improving state oversight of such clinics and subjecting clinics to state inspection. Regulations detail management and structure of the business, rather than or in addition to treatment practices for pain management. In contrast, regulations of individual providers do not require practitioners to register with the state, nor do they subject practitioners to inspection. They focus almost exclusively on how to provide pain management treatment with narcotics, detailing maximum opioid dosage, number of days per prescription, required consultations with specialists, and/or required physical examinations. Such laws are far more common than laws specifically regulating pain clinics.

As used in this paper, the term “safe harbor law” has two meanings. First, it refers to any state law provision that explicitly exempts certain pain clinics from regulations, even though these clinics fall within the definition of “pain clinic.” For example, a state law exempting pain clinics associated with hospitals from regulations is a safe harbor law. Second, “safe harbor law” also refers to state law provisions that explicitly exclude certain types of clinics from the definition of “pain clinic.” For example, a state law explicitly exempting addiction treatment clinics from the definition of pain clinics is a safe harbor law.