Pill Mills Are Not Pain Clinics: The Challenge of Addressing One Without Harming the Other

Pill Mills Are Not Pain Clinics

Previous policy efforts to facilitate eliminating pill mills have focused largely on developing new laws, regulations, and rules regarding the standards of practice in pain management clinics. The fact that most pill mills label themselves as “pain clinics” is the primary reason for this focus. However, the fact that pill mills call themselves pain clinics does not make them such, and as policymakers debate how to eliminate the former, care should be exercised not to harm the latter. For the sake of clarity, consider some of the key characteristics of pill mills and pain clinics:

• In a pill mill, an extremely cursory history is taken and a physical exam often consists of little more than a quick glance to ensure that the “patient” is breathing. Referrals from other practitioners are not required; notes from previous health care encounters are not solicited or reviewed; and if laboratory and diagnostic test results are presented, they are accepted regardless of how old they are, whether or not they have positive findings, and even if they appear to be obviously falsified. The decision about what prescription to write is based on the customer's response to the question, “What do you want me to give you?”, rather than the physician's response to the question “What is the best option, in my professional opinion?” Every patient is prescribed controlled substances, to the exclusion of other medications. Documentation is inadequate, if it exists at all, and follow-up visits are not scheduled. Referrals to other providers are never made. Medications are dispensed in the next room, and the customer walks away with hundreds of doses of (often multiple) controlled substances. Insurance is not accepted, so all services are provided on a cash-only basis.

• In a pain clinic, a thorough assessment with complete history and physical exam is conducted. Notes from referring physicians, laboratory findings, and previous diagnostic study results are reviewed and new ones ordered if necessary. A comprehensive treatment plan is developed based on the assessment and the provider's professional judgment. The treatment plan often involves more than one discipline and type of intervention, and controlled substances may or may not be prescribed. Complete documentation of the assessment and plan is placed into a medical chart, and the patient is scheduled for a follow-up visit or referred to another provider for that follow-up. If a prescription has been written, it is most often taken to a pharmacy, where a second health care professional reviews it for accuracy and safety, then dispenses the medication and educates the patient if the prescription is judged to be appropriate. At each step, payment by insurance is accepted if the patient and providers are covered.

Clearly, what goes on in a pill mill does not meet the standard for lawful prescribing of controlled substances; that is, that they “must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.”5 The United States Drug Enforcement Administration also requires prescribers and dispensers to make “reasonable efforts to prevent abuse and diversion,”6 yet pill mills either ignore these issues or intentionally cater to them. Without meeting these standards, the act of prescribing violates federal law, and undoubtedly state law in all or nearly all states; yet authorities report difficulty in closing pill mills. To make closing them more expedient, do we need new statutes, rules, and regulations to make what goes on there more illegal? Or do we need to find more effective ways of exposing them to professional and legal sanctions under existing policies?

Why Do We Struggle to Close Pill Mills?

The primary challenge in addressing pill mills is the requirement for most professional licensing boards that a complaint be filed before an investigation can be opened. Clearly, customers who depend on pill mills for the medications on which they may be physically dependent, to which they may be addicted, and which may constitute their sole source of income, are not going to complain about receiving substandard medical care. Other health care professionals who become aware of a pill mill may not feel that they have sufficient evidence to file a complaint, and may be afraid to do so for fear of reprisal from pill mill operators. Moreover, few physicians understand medical practice act rules on reporting inappropriate behavior of other licensees. Law enforcement agencies are reluctant to file complaints even when they have sent undercover officers into the pill mill because they do not want to blur the lines between law enforcement and health care regulation, and do not want to risk exposing their investigations. Insurance companies will not complain because the pill mill operates on a cash-only basis, leaving them on the sidelines as disinterested spectators. Who is left to complain?

The investigation of a pill mill, if one can be opened, often proceeds slowly because of a backlog of cases to be addressed by understaffed and underfunded licensing boards. In some cases, standard practice is to avoid opening full-scale investigations unless multiple complaints are filed. Fear of violence against investigators certainly complicates the conduct of the investigation if one is opened. Finally, the most effective investigatory strategy is one in which an unannounced inspection is carried out, so that investigators can see what is going on in the clinic on a regular basis, yet such inspections may not be permitted by law.

Sanctioning owners and practitioners in pill mills after violations are found can be difficult as well. As has been well documented in Florida, some states allow medical clinics to be owned and operated by people without a professional license, making those individuals and the clinics themselves immune to actions by licensing boards. The only people subject to administrative sanction are the licensed professionals, and pill mill owners have little trouble replacing them with others who are willing to serve as hired prescription writers. Couple that with the requirement in some jurisdictions that a pattern of unprofessional behavior be in evidence (suggesting the need for multiple or repeated complaints), and even imposing a harsh sanction such as suspension or revocation of a license can become a challenge, regardless of how bad a single case may be.

Targeting Pill Mills, Not Pain Clinics

Can we successfully address this problem by allowing licensing boards greater freedom to act against the illegal practices of pill mills? If so, how? To date, seven states (Louisiana, Texas, Florida, Ohio, Tennessee, Kentucky, and West Virginia) have tried to do this by passing statutes to regulate pain clinics and one additional state, Georgia, has approved new medical licensing board rules to do the same. The underlying thought is that, since pill mills call themselves pain clinics, they should be held to the high standards of practice one would expect to see in specialty clinics, effectively making their typical behavior more illegal. Given that pain clinics currently do not have special standards in most jurisdictions, policymakers are developing new standards that are higher than those expected of other medical practices, sometimes including features that allow for inspections without complaints being filed.

While this may be an effective strategy, it is misguided and risks exacerbating a public health problem much greater than the size of the prescription opioid misuse problem — namely, chronic pain. As noted, millions of Americans live daily with chronic pain. The strategy of setting higher standards for pain clinics in an effort to close down pill mills is analogous to this scenario: Faced with the presence of a “crack house” in the middle of a residential neighborhood, the city council responds by requiring that all the homeowners in that subdivision pour new driveways, paint their houses, and install new roofs. Unfortunately, this strategy will result in some homeowners leaving the neighborhood, and it is much more costly and inefficient than just raiding and closing the “crack house.”

Dramatic changes in medical practice have taken place in states implementing new pain clinic policies, and the fear is that legitimate pain clinics, already in short supply, will simply “leave the neighborhood.” For instance, in Ohio, one criterion defining a pain clinic is “the majority of the patients of the prescribers at the facility are provided treatment for pain or chronic pain that includes the use of controlled substances, tramadol or carisoprodol, or other drugs specified in rules by the board.”7 At the public hearing before these rules were promulgated, three independent witnesses testified that they had received information about physicians abruptly ceasing to prescribe controlled substances for some patients to ensure they would not exceed the 50 percent limit in their practices. Some of those patients were noted to have been seen in other clinics and in emergency departments suffering from acute opioid withdrawal. These were not people with addictions, but people with pain who were being treated appropriately and who had developed the expected physical dependence on opioids. In short, poorly conceived policies or rule changes can harm legitimate patients. Are we comfortable if such changes bankrupt innocent people with chronic pain and put some of them through opioid withdrawal as a consequence?

There are alternative strategies to strengthen our ability to address the pill mill problem without imposing onerous higher standards on pain clinics. These strategies do not risk our response to the pandemic that finds an estimated 100 million adult Americans with chronic pain, costing us about $600 billion every year.8 The following are proposed as starting points for discussion:

• Require that all medical practices be owned by licensed health care practitioners, either individually or jointly through instruments such as professional associations or professional limited liability corporations.

• Require that all medical practices designate a qualified medical director who is responsible for overseeing practices within the clinic and ensuring that they are appropriate and meet relevant legal and ethical standards.

• If they do not already exist, promulgate licensing board rules for all medical practices, clearly stating what constitutes evidence of a legitimate medical purpose and standards for the usual course of professional practice, as well as identifying best practices for reasonable steps to prevent abuse and diversion.

• Allow all professional health-related licensing boards to carry out unannounced inspections of medical practices without a complaint being filed, as is already allowed in some states. (Note that this would also require development of criteria for which practices should be inspected, and may require reallocation of resources. Effective action by licensing boards should reduce the need for law enforcement activity around pill mills, so perhaps those agencies could assist with funding.)

• Limit dispensing of controlled substances from medical practices, either by restricting them to an emergency supply sufficient to allow the patient to get to a pharmacy, or by making such dispensing subject to relevant pharmacy rules and regulations. (Note that this may require pharmacy licensing boards to regulate this portion of the practice and to carry out unannounced inspections without cause as well.)

• Require any dispensing from a medical practice to be reported to the state's prescription monitoring program.

• Allow licensing boards to make a judgment about the severity of dangers to both individual patients and the public posed by practices uncovered in investigations and then to issue sanctions commensurate with those dangers without having to wait for the accumulation of a series of cases showing a pattern of misbehavior.

• Encourage greater cooperation between licensing boards and law enforcement, such that law enforcement does not hesitate to ask a board's opinion about the appropriateness of medical practices and boards are not reluctant to refer providers for possible criminal prosecution if they believe the behavior in evidence crosses the line between medical malpractice and criminal behavior.

Pain clinics also can promote these efforts by doing some of the following:

• Using sound medical practices in all respects and fully documenting all aspects of a patient's care.

• Obtaining education and developing referral networks that enable them to design and implement treatment plans with multiple types of interventions (e.g., pharmacotherapy along with physical therapy, psychotherapy, acupuncture, etc.) addressing all of the biopsychosocial aspects of chronic pain, thereby de-emphasizing the role of controlled substances.

• Using prescription monitoring programs on a regular basis to ensure that their patients are not also patronizing pill mills or other providers who are prescribing the same or similar medications; some newer laws and rules are requiring that this be done.

• Reviewing licensing board rules on ethical and legal obligations to report suspected illegal activity on the part of fellow licensees.

• Not hesitating to file complaints when they uncover evidence of pill mill activity, and asking authorities to take any necessary steps to ensure that they are protected from reprisals for making legitimate complaints.

• In general, pain clinics and the professional societies of which they and their practitioners are members need to foster a greater sense of cooperation with law enforcement and professional licensing boards to ensure that their concerns are heard; that any new standards are reasonable and effective; and in general that their practices, and their ability to provide the highest quality of care for people with chronic pain, are protected.

Through this kind of policy development, pill mills could be selectively eliminated without endangering care delivered at legitimate, professional pain clinics. We should make this approach a top priority.