Abstract
Background
In response to the opioid crisis, U.S. states have passed laws requiring urine drug testing (UDT) when opioid analgesics are prescribed for chronic pain. We sought to identify state law UDT requirements.
Methods
We searched NexisUni legal database using terms related to UDT, chronic pain, and opioids. We included laws effective during spring 2022 that required UDT when opioids were prescribed for chronic pain. We performed deductive content analysis, coding laws for mandated UDT frequency, type of clinician and type of payer to whom the law applied, and circumstances under which UDT was mandated.
Results
We found 32 laws across 13 states that met our inclusion criteria. UDT requirements varied substantially by state, including with regard to the type of clinician to whom the law applied, the mandated frequency of UDT (eg, at initiation/assessment, at least annually, more than once per year), and the circumstances in which UDT was mandated (eg, patient had substance use disorder; dosage/day threshold).
Discussion
Relatively few states have UDT mandates associated with prescribing opioids as chronic pain treatment. When developing policy indicators for empirical studies, researchers evaluating how UDT policy affects health outcomes must consider the complexity and lack of uniformity of UDT requirements. In addition, even if states mandate UDT, it is unclear whether clinicians understand the best way to use the test results.
Keywords: opioids, analgesics, laws, policies, urine drug screening, urine drug testing, chronic pain
Introduction
An estimated 100 000 people in the United States died from drug overdoses in 2021, and most deaths involved opioids.1 Clinician overprescribing of opioid analgesics during the 1990s contributed to the opioid overdose crisis,2 prompting federal and state efforts to decrease clinically unnecessary opioid prescribing. These initiatives include federal chronic pain management guidelines for prescribing opioid analgesics,3 as well as state statutory and regulatory requirements related to opioid analgesic prescribing,4 including prescription drug monitoring programs, continuing medical education, opioid dosage and formulation limitations, pain clinic registration and inspection, limits on duration of treatment, and urine drug testing (UDT) requirements.5
UDT involves collecting and analyzing urine samples to detect alcohol, drugs, and their metabolites. It is generally considered a way to objectively monitor treatment or to determine whether the patient is taking other substances, such as other prescriptions or illicit substances. Monitoring treatment enables prescribers to refer patients to opioid use disorder treatment if necessary or to change their approach to pain management in response to opioid misuse. UDT has been also proposed as a quality metric for patients on long-term opioid pharmacotherapy; however, the appropriateness of UDT as a quality metric is questionable, given concerns about its accuracy6 and the inconsistency with which it is applied across diverse patient populations.
Although numerous studies have examined the relationship between many state-level opioid analgesic prescribing requirements and a range of outcomes,7,8 few studies have examined the effects of UDT policies.8 One challenge for researchers seeking to assess UDT policies is the absence of a longitudinal dataset of state UDT policies. As a first step toward developing such a database, we report on efforts to identify state laws mandating UDT for opioid analgesic prescribers treating chronic pain, including trends by clinician type and payer type. We examined laws effective in all 50 states and the District of Columbia during early 2022 and performed deductive content analysis.
Methods
To identify state laws mandating UDT for opioid analgesic prescribers treating chronic pain, we searched NexisUni legal database using terms related to UDT, opioids / controlled substances / narcotics, and pain, examining statutes and regulations effective at some point during January through April of 2022 in all 50 states and the District of Columbia. See Supplementary Appendix A for search terms.
The initial search yielded 236 laws (ie, statutes and regulations). Inclusion criteria were as follows: The law applied to prescribing of opioids, all controlled substances, or all schedule II–V controlled substances; the law applied to chronic pain treatment or management; and the law discussed UDT. We excluded laws applicable only to pharmacist dispensing of substances or to substance use disorder treatment. We did not examine mere recommendations for UDT, as prior studies suggested that mandates in state laws are more likely to have effects on prescribing behavior.9 Three members of the research team, supervised by the lead author (a licensed attorney), independently examined each law to ascertain whether it met the inclusion/exclusion criteria, with research team members marking their decision on an Excel (Microsoft Corp., Redmond, WA, United States) sheet. Excel sheets were compared; discrepancies were resolved by team discussion. The resulting revised sample consisted of 201 laws. After further reviewing the laws in Dedoose qualitative software,10 the team decided to exclude laws that merely recommended or described UDT, yielding a final sample of 32 laws that mandated some use of UDT. See Figure 1 for a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagram of the data collection inclusion/exclusion process.
Figure 1.
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram of data collection.
The lead author created a codebook based on a preliminary review of the final sample, with codes describing the frequency with which UDT was mandated (eg, more than once per year), circumstances under which UDT was mandated (eg, if a dosage threshold was surpassed), payer type (eg, Medicaid), and type of clinician to whom the law applied (eg, nurse practitioners). The research team then implemented a deductive content analysis, independently applying codes and then meeting biweekly as a team to discuss coding discrepancies. One law could have multiple codes applied. During this process, the codebook was iteratively revised to reflect newly identified types of relevant laws.
Ascertaining the type of clinician to whom a UDT law applied was not always straightforward. If the clinician was not clearly specified in the legal text, we examined the broader context in which the law was located (eg, a law located in a section titled “State licensing of nurse practitioners” was likely applicable to nurse practitioners) and any other definition, purpose, and applicability statements in related laws. If the law used a vague term, such as “clinician,” “prescriber,” or “provider,” and the previously described process did not yield further clarity about applicability, we presumed that the rule was at least applicable to physicians and to any advanced practice clinicians whom the Drug Enforcement Administration listed as having prescriptive authority for the most commonly dispensed opioids in 2022.11
Results
The 32 laws identified were from 13 states: Arkansas, Colorado, Delaware, Louisiana, Maine, Mississippi, New Hampshire, New Mexico, North Carolina, Ohio, Pennsylvania, Washington, and West Virginia. Legal text and citations for each law are in Table 3.
Table 3.
Relevant legal text and citations.
| State | Clinician type | Relevant legal text and short citation | Payer type | Policy type | |
|---|---|---|---|---|---|
| 1 | Arkansas | Physicians, physician assistantsa |
|
Workers’ compensation | Mandate based on day/dose threshold |
| 2 | Arkansas | Physicians, physician assistants |
|
Neither Medicaid nor workers’ compensation | Mandate based on day/dose threshold |
| 3 | Arkansas | Nurse practitioners |
|
Neither Medicaid nor workers’ compensation | Mandated but frequency not specified / unavailable |
| 4 | Arkansas | Podiatrists |
|
Neither Medicaid nor workers’ compensation | Mandate based on day/dose threshold |
| 5 | Colorado | Physicians, physician assistants, nurse practitionersa |
|
Workers’ compensation | Mandated at initiation/assessment; mandated at least annually |
| 6 | Delaware | Physicians, dentists, podiatrists, nurse practitioners, physician assistants |
|
Neither Medicaid nor workers’ compensation | Mandated more than once per year |
| 7 | Louisiana | Physicians, optometristsa |
|
Workers’ compensation | Mandated at least annually |
| 8 | Louisiana | Physiciansa |
|
Workers’ compensation | Mandated at initiation/assessment; mandated more than once per year |
| 9 | Louisiana | Physiciansa |
|
Workers’ compensation | Mandated at initiation/assessment; mandated more than once per year |
| 10 | Louisiana | Physiciansa |
|
Workers’ compensation | Mandated at initiation/assessment; mandated more than once per year |
| 11 | Maine | Physicians, physician assistants, nurse practitionersa |
|
Medicaid | Mandated at initiation/assessment; mandated more than once per year |
| 12 | Maine | Nurse practitioners |
|
Neither Medicaid nor workers’ compensation | Mandated at initiation/assessment; mandate based on day/dose threshold |
| 13 | Maine | Physicians |
|
Neither Medicaid nor workers’ compensation | Mandated at initiation/assessment; mandate based on day/dose threshold |
| 14 | Maine | Podiatrists |
|
Neither Medicaid nor workers’ compensation | Mandated at initiation/assessment; mandate based on day/dose threshold |
| 15 | Maine | Physicians, nurse practitioners, podiatrists |
|
Neither Medicaid nor workers’ compensation | Mandated at initiation/assessment; mandate based on day/dose threshold |
| 16 | Mississippi | Physicians, physician assistants, podiatrists |
|
Neither Medicaid nor workers’ compensation | Mandated more than once per year |
| 17 | Mississippi | Nurse practitioners |
|
Neither Medicaid nor workers’ compensation | Mandated at initiation/assessment; mandated before each prescription |
| 18 | New Hampshire | Physicians and physician assistants |
|
Neither Medicaid nor workers’ compensation | Mandate based on day/dose threshold |
| 19 | New Hampshire | Nurse practitioners |
|
Neither Medicaid nor workers’ compensation | Mandate based on day/dose threshold |
| 20 | New Hampshire | Podiatrists |
|
Neither Medicaid nor workers’ compensation | Mandate based on day/dose threshold |
| 21 | New Hampshire | Dentists |
|
Neither Medicaid nor workers’ compensation | Mandate based on day/dose threshold |
| 22 | New Hampshire | Optometrists |
|
Neither Medicaid nor workers’ compensation | Mandate based on day/dose threshold |
| 23 | New Hampshire | Naturopaths |
|
Neither Medicaid nor workers’ compensation | Mandate based on day/dose threshold |
| 24 | New Mexico | Physiciansa |
|
Neither Medicaid nor workers’ compensation | Mandated at initiation/assessment; mandated more than once per year |
| 25 | North Carolina | Physiciansa |
|
Workers’ compensation | Mandated at initiation/assessment; mandated more than once per year |
| 26 | Ohio | Physicians, podiatrists |
|
Neither Medicaid nor workers’ compensation | Different mandate for patients with SUD |
| 27 | Ohio | Dentists |
|
Neither Medicaid nor workers’ compensation | Different mandate for patients with SUD; mandate based on day/dose threshold |
| 28 | Ohio | Physicians, nurse practitioners, physician assistantsa |
|
Workers’ compensation | Mandate based on day/dose threshold |
| 29 | Pennsylvania | Physicians, nurse practitioners, physician assistants |
|
Neither Medicaid nor workers’ compensation | Mandated at initiation/assessment; different mandate for patients with SUD |
| 30 | Pennsylvania | Physicians, nurse practitioners, physician assistants |
|
Neither Medicaid nor workers’ compensation | Mandated at initiation/assessment; different mandate for patients with SUD |
| 31 | Washington | Physicians, physician assistants, nurse practitionersa |
|
Workers’ compensation | Mandated but frequency not specified / unavailable |
| 32 | West Virginia | Pain management clinic |
|
Neither Medicaid nor workers’ compensation | Mandated at initiation/assessment; mandated more than once per year |
Abbreviations: SUD = substance use disorder; PMP = prescription monitoring program; MED = morphine equivalent dosing.
Type of clinician to whom the law applies is unclear. Therefore, we listed those known to have prescriptive authority for Schedule II controlled substances in the state, excluding dentists and podiatrists.
UDT laws applicable regardless of payer type
Multiple states had broadly applicable laws. Nine states had UDT laws that applied to clinicians regardless of payer: Arizona, Delaware, Maine, Mississippi, New Hampshire, New Mexico, Ohio, and West Virginia. Seven of these states had a UDT law applicable to physicians; 6 states had a UDT law applicable to nurse practitioners and/or physician assistants; 6 states had a UDT law applicable to other clinician types (eg, podiatrists, dentists, optometrists); and 1 state had a UDT law applicable to licensed pain clinics.
In 6 states, UDT was required at opioid / controlled substance prescribing initiation or during the health assessment for prescribing initiation. These laws might also require subsequent UDT. For example, a New Mexico law stated: “(B)(7) When prescribing opioids for chronic pain, practitioners shall require urine drug testing when starting opioid therapy and shall use urine drug testing at least every six months to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.”12
Two states had different UDT requirements for patients with substance use disorder versus patients without substance use disorder. An Ohio law stated: “If evidence of substance misuse or substance use disorder exists, diagnostic testing shall include urine drug screening.”13
Four states had UDT requirements applicable if a day/dosage prescribing threshold was surpassed. For example, a New Hampshire law stipulated that clinicians must “Require random and periodic urine drug testing at least annually for all patients using opioids for longer than 90 days.”14
In 3 states, UDT was mandated more than once per year. One state mandated UDT before each prescription (ie, for each refill). For 1 state, the mandated UDT frequency was unavailable.
See Table 2 for distribution of laws by clinician type, circumstances in which UDT is required, and frequency with which UDT is required.
Table 2.
Distribution of UDT laws by state—nonspecific payer.
|
UDT laws applicable only to Medicaid or workers’ compensation services
Some laws were applicable to specific payers.
Only Maine had a UDT law applicable exclusively to treatment covered by Medicaid. The law applied to physicians, nurse practitioners, and podiatrists; it required UDT at the time of initiating opioid prescribing or during a health assessment for initiating opioid prescribing but only if a specific day/dosage threshold was passed.
Six states—Arkansas, Colorado, Louisiana, North Carolina, Ohio, and Washington—had UDT laws applicable to workers’ compensation services. In all of these states, the law applied to physicians; however, in some of the states, the law also applied to non-physician prescribers of opioid analgesics for chronic pain.
In 3 states, the workers’ compensation law required UDT at initiation/assessment of opioid prescribing for chronic pain. For example, a Louisiana law stated: “Chronic use of opioids should not be prescribed until the following have been met: urine drug screening for substances of abuse and substances currently prescribed.”15
In 2 states, the workers’ compensation law required UDT only if a specific day/dose threshold was surpassed. For example, in Ohio, a workers’ compensation law stated: “[W]hen prescribing opioids at or above an average daily dose of fifty [morphine milligram equivalents] per day, the prescriber must complete and document in the patient records: (b) Urine drug screens, with frequency based upon the results of the validated risk assessment and upon presence or absence of aberrant behaviors or other indications of substance misuse, abuse, substance use disorder, or diversion.”16
The frequency with which UDT was required varied. Frequency was unclear in 1 state; 2 states required UDT at least annually; and 2 states required it more than once per year. For example, a Louisiana law specified that random drug testing “should be 4 times a year or possibly more with documented suspicion of abuse or diversion.”17
See Table 1 for distribution of workers’ compensation UDT laws by clinician type, circumstances in which UDT is required, and frequency with which UDT is required.
Table 1.
Distribution of UDT laws by state—workers’ compensation.
|
Approaches to states introducing UDT requirements
Broadly speaking, we found 4 ways in which states introduced UDT requirements in their statutes or regulations: stating that UDT was required for opioid analgesic prescribing for chronic pain; stipulating that certain practices, including the lack of UDT, would subject clinicians to disciplinary action; explaining that only certain practices, including UDT, would enable a payer to pay for a prescription; and describing UDT as a requirement within another requirement (eg, as a part of pain management contracts).
Most laws we identified introduced UDT as a required step among other steps (eg, checking prescription drug monitoring programs, completing physical evaluations) when opioid analgesics were prescribed for chronic pain. For example, a law in Delaware stated: “In addition to the requirements of subsection 9.6, the practitioner must adhere to the following additional requirements for Chronic Pain patients: Administer fluid drug screens at least once every six months.”18
A few laws described UDT as a requirement for a payer to cover an opioid analgesic prescription. For example, a workers’ compensation law in Arkansas stated: “A Payor shall not be required to pay for continuing an opioid medication beyond 90 days without written certification to the Payor of medical necessity which shall include the following: … A plan for periodic urinary drug screening.”19
Rarely, laws described UDT requirements within the context of disciplinary action. For example, another Arkansas law stated that malpractice includes “excessive prescribing” and that “excessive” includes prescribing of more than 50 morphine milligram equivalents per day without UDT.20
A few laws described UDT requirements as a part of another requirement for opioid prescribing, such as part of a pain management contract (eg, the law requires pain management contracts, which require informing patients they will have UDTs) or as part of a baseline health assessment (eg, the law requires baseline health assessments, which require UDTs as part of the assessment). For example, a Pennsylvania law stated: “A baseline test, periodic test or targeted test shall be used to establish a general assessment for an individual new to treatment for chronic pain.”21 A Louisiana law required “a shared decision-making agreement detailing the following: use of random drug screening, initially, four times a year or possibly more with documented suspicion of abuse or diversion or for stabilization or maintenance phase of treatment.”22
It was also relatively common for UDT laws to stipulate that results be documented in the medical record. For example, a Maine law required that “Clinicians shall be responsible for documenting in the patient's medical record the time, date and results of the toxicological drug screens.”23
Discussion
The present study is among the first studies to describe state laws mandating UDT for opioid analgesic prescribing for chronic care and is the most recent study to identify such laws.24 We identified 32 laws across 13 states that met our inclusion criteria. UDT requirements varied substantially across states, including with regard to circumstances in which UDT is required (eg, when a dosage/day threshold is surpassed), frequency (eg, at least annually), clinician type (eg, physician), and payer (eg, workers’ compensation). Such cross-state variation in UDT requirements should be carefully considered if researchers use UDT policy indicator variables in future policy evaluation studies.
The fact that relatively few states require rather than merely recommend UDT for opioid analgesic prescribing is relatively surprising given the recent flurry of legal activity as states attempt to address the opioid overdose crisis. It appears that states do not view UDT as an important component of their strategy to address the crisis, as compared with other types of statutory/legislative activity, such as more widespread requirements for prescription drug monitoring programs.9
Consensus guidelines for UDT during opioid pharmacotherapy leave substantial room for clinician discretion.3 Existing studies reveal substantial variation in UDT practices among clinicians who prescribe opioid analgesics for chronic pain.25 Clinicians can differ in their use of presumptive versus definitive testing and in the number and types of substances that they might order on a definitive panel. Clinicians might require UDT in some circumstances (eg, when opioid analgesic doses are high) or in all circumstances when prescribing opioid analgesics. Similarly, clinicians might conduct a UDT only at the time of initial prescribing or repeatedly throughout treatment. Studies also suggest that clinicians apply UDT inequitably across patient populations: UDTs are performed more frequently on racially minoritized patients than on White patients.26–28 Thus, state laws mandating specific UDT requirements could help decrease racial disparities in testing.
Even though state laws mandating UDT requirements could decrease heterogeneity in UDT practices, it is unclear which specific UDT practices improve health outcomes and whether UDT overall improves health outcomes. For example, in its opioid prescribing guidelines, the U.S. Centers for Disease Control and Prevention categorizes recommendations for UDT as the lowest strength of evidence (category D), meaning that the evidence is from “clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several limitations.”3
Given the weak evidence base for UDT prescribing recommendations and the lack of evidence that state UDT policies improve health outcomes, states should approach adopting and implementing statutory/regulatory UDT requirements cautiously. Also, some studies suggest that clinicians have limited knowledge about how to interpret UDT requirements.30,31 Therefore, states that require UDT when opioid analgesics are prescribed could consider coupling this policy requirement with appropriate continuing medical education requirements to encourage clinicians to use UDT appropriately.
Rapid UDT tests performed in the clinic have relatively poor accuracy.32 For example, immunoassay tests are intended to be only presumptive and should be confirmed by laboratory testing—a more costly process that some payers might discourage.32 Several other factors could also result in false UDT results, such as timing of medication use and medication-to-medication interaction.33 These potential “pitfalls” reinforce the importance of adequate clinician training in UDT if it is to be mandated by states.
If used appropriately, UDT could potentially benefit both patients and public health surveillance.33 For example, UDT could help clinicians identify patients who would benefit from substance use disorder treatment. Aggregate UDT trends could also inform public health monitoring of drug use trends, including in diverse populations.33 Unfortunately, UDT has sometimes been used inappropriately to discontinue opioid treatment,34 with the unintended consequence of patients then seeking illicit opioids that are often more dangerous (eg, fentanyl34). Depending on how UDT is used, it can either hinder or help the patient–clinician therapeutic relationship.35 New Hampshire law, for example, stipulates that “Unanticipated findings [of the UDT] shall be addressed in a manner that supports the health of the patient.”36
Our study has several important limitations. First, some relevant state UDT policies (eg, plan amendments in the Medicaid program) are not regulatory or statutory in nature—in which case, they would not have been captured in our NexisUni search. Relatedly, we did not examine federal laws. For example, the Centers for Medicare and Medicaid Services has UDT requirements related to local coverage determination for chronic opioid treatment,37 and we did not capture these requirements. Also of note, the federal Clinical Laboratory Improvement Amendments require that laboratories testing human specimens for health/treatment purposes follow UDT manufacturer recommendations (eg, confirmatory testing of presumptive results), which might differ from state law requirements. Second, we did not analyze laws applicable only to acute pain. However, chronic pain can begin as acute pain, so in practice, a clinician treating pain might need to follow both sets of laws. Third, the definition of “chronic pain” varies by state and payer—something that we did not track in our study but that could cause variation in policy effects. Fourth, although we sought to identify the clinician type to which each law applied, in some cases it was unclear whether the law applied to clinicians other than physicians and mid-level clinicians identified in a listing of mid-level practitioners with prescriptive authority in each state for Schedule II controlled substances; however, information about some clinicians (eg, dentists) is excluded.11 Furthermore, even though the most frequently dispensed opioids are Schedule II controlled substances, opioids also exist in other schedules.38 Therefore, it is possible that our study underreports the types of clinicians to whom UDT mandates apply in the context of prescribing opioid analgesics for chronic pain. Also, many states specify exceptions to the policies we identified, including for patients receiving opioids for cancer-related pain, hospice treatment, nursing home–administered opioids, and inpatient treatment. We did not track these exceptions. Finally, in this pilot study we did not assess the type of UDT required by state laws (eg, presumptive versus definitive). Future work should further assess state laws by UDT type required, as different requirements could have different impacts on health outcomes.
Conclusion
In our national review of state laws effective at some point during January through April 2022, we found that only 13 states had laws mandating UDT in the context of prescribing opioid analgesics for chronic pain. The laws varied substantially across states, including with regard to the type of clinician to whom they applied, type of payer to whom they applied (if any), frequency of mandated UDT, and circumstances in which UDT mandates applied. Therefore, researchers seeking to evaluate how UDT policies affect health service utilization and health outcomes will need to grapple with the complexity and heterogeneity of UDT laws and avoid simple binary indicator variables (eg, UDT law exists / does not exist). Finally, until stronger evidence exists that UDT practices and state policies improve patient health outcomes, it is unclear whether states should adopt and implement UDT policies.
Supplementary material
Supplementary material is available at Pain Medicine online.
Supplementary Material
Contributor Information
Barbara Andraka-Christou, School of Global Health Management & Informatics, University of Central Florida, Orlando, FL 32801, United States; Department of Internal Medicine (Secondary Joint Appointment), University of Central Florida, Orlando, FL 32827, United States.
Elizabeth McAvoy, O'Neill School of Public and Environmental Affairs, Indiana University, Bloomington, IN 47405, United States.
Adam J Gordon, Informatics, Decision-Enhancement, and Analytic Sciences (IDEAS) Center, VA Salt Lake City Health Care System, Salt Lake City, UT 84108, United States; Program for Addiction Research, Clinical Care, Knowledge and Advocacy (PARCKA), Division of Epidemiology, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT 84108, United States.
Maggie Ohama, The Cardiac and Vascular Institute, Gainesville, FL 32605, United States.
Marilyn Brach, Trinity College, Hartford, CT 06106, United States.
Erin A Taylor, RAND Corporation, Santa Monica, CA 90401, United States.
Mary Vaiana, RAND Corporation, Santa Monica, CA 90401, United States.
Brendan Saloner, Department of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21205, United States.
Bradley D Stein, RAND Corporation, Pittsburgh, PA 15238, United States.
Funding
Funding was received from the NIH National Institute on Drug Abuse, Award # 5R01DA045055-02, with principal investigator B.D.S. from the RAND Corporation.
Conflicts of interest: Authors have no conflicts of interest to declare.
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