CHAPTER 4
EDUCATIONAL REQUIREMENTS SURVEY (STUDY 2)

BACKGROUND

Regulatory agencies and organizations, whether legislative (e.g., state licensing boards) or involved in professional self-regulation (e.g., accreditation and certification) can play a supportive and facilitating role in addressing PPGs in OUD/SUDs and pain management practices. There is currently a myriad of regulatory agencies across the multiple health professions. Additionally, a lack of or discordant regulatory standards and practices may also serve as barriers to addressing the opioid crisis. The purpose of this evaluation was to gain an initial understanding of the regulatory landscape with regards to educational requirements and standards using a web-based survey approach. The goal of this survey was not to be comprehensive, but rather to develop an initial taxonomy of themes and practices among a heterogeneous group of regulators to guide subsequent work and initiatives of the collaborative. The high-level results provide the reader an overview of the multifaceted and fragmented health professions regulatory systems and the complexities that ensue from the design of the current systems. This overview, when integrated with the literature review, can begin to link the PPGs with specific components and activities of the regulatory systems.

OBJECTIVES AND METHODS

Survey Design and Strategy

Members of the Health Professional Education and Training Workgroup developed an online survey primarily to obtain a high-level scan of regulatory policies and requirements for a) acute and chronic pain management and b) substance use disorder (see Appendix C). There is a lack of consistent distinction between OUD and SUDs across requirements, standards, and policies. Thus, in order to comprehensively capture data, the survey questions focused on SUDs. The survey, conducted between August

2019 and February 2020, specifically targeted the Collaborative’s regulatory member organizations in accreditation, certification, and licensure. The identities of survey respondents were anonymized.

A two-stage process was used to create the survey sample. First, members of the Collaborative were asked to complete the survey on behalf of their organization as a convenience sample. Second, members of the Collaborative were asked, using a partial snowball technique, to recommend other related organizations to complete the survey. Briefly, a snowball sampling technique allows one participant to recommend another participant sequentially to help ensure a broader pool (Patton, 1990). Snowball sampling is particularly suited to assessing the landscape of a current state of affairs. A single individual completed the survey on behalf of their organization. The specific health professions sampled included: 1) nursing (including advanced practice nurses); 2) medicine (allopathic and osteopathic physicians); 3) dentistry (including professionals with DDS and DMD degrees, dental assistants, and hygienists; 4) pharmacy (including pharmacists and pharmacy technicians); and 5) physician assistants. If a regulatory organization was responsible for other professions, the organization could list these professions.

Policy Review

In addition to answering the survey questions, survey respondents could provide their policies, standards, or requirements for health care professionals (students, residents, fellows, or practicing health care professionals), learners, and trainees in two domains—acute and chronic pain management and SUDs. This was performed to complement the survey and provide more detail and examples around specific policies that provided additional context to the quantitative survey results. Twenty-two of the respondents provided their policies on treating acute and chronic pain, and 19 provided their policies on treating patients with SUDs. This information provided some additional insights into the nature of the activities and policies of the responding organizations (see Appendix D).

Eligibility Criteria

Inclusion in the analysis required that the policy be from a regulatory agency, state licensing board, or accreditor, and be a patient- or provider-related outcome. Policy was defined as a legislative or administrative action, such as a law or regulation that directly targeted opioid use. For example, naloxone access laws are a legislative action in that they intend to affect naloxone access by increasing who has access to prescribe, dispense, and possess naloxone. Prescription drug monitoring programs (PDMPs) are also included because they are often established through a formal governmental or regulatory action.

This analysis is restricted to the policies provided by the survey respondents and does not consider any organizational laws, state policies, or federal laws that were not provided by participants. Human resource policies, insurance policies, editorial pieces, and peer-reviewed studies were excluded from this review.

Data Extraction

Walt and Gilson’s policy triangle framework was the basis for this analysis as policy themes were characterized into content, context, actors, and process (Walt and Gilson, 1994). This framework was originally proposed in 1994 and was designed to help the health policy field extend its focus beyond just the content of policy to include the actors, context, and processes of the policy. The framework places the actor at the center of the triadic and interdependent relationship between content, process and context. This framework enables the analysis of the content of the policy; the actors involved in the decision making; the process by which the policy was started, articulated, and communicated; and the contextual factors that influenced the policy. This framework can be used retrospectively, which allows researchers to understand the full context of the policy-making process.

To synthesize the findings, each extraction sheet (i.e., structured abstraction tool) was read and coded using analysis techniques from primary qualitative studies. The extraction summaries were loaded into the software program NVivo in the form of individual documents. Each document was then read on a line-by-line basis, and a code was assigned to chunks of text in line with primary qualitative data analysis methods. Following the coding of the documents, the data within each code were reviewed for consistency by a researcher.

DATA ANALYSIS AND SYNTHESIS

The initial stages of survey analysis (conducted by Lauren Poulin and Eric Holmboe, both working on behalf of the Collaborative) encompassed a thematic analysis of the survey data involving an iterative, interwoven process of data acquaintance, data reduction, data presentation, and summarizing. Miles and Huberman’s approach was chosen for guiding the initial stages of analysis because their analytic techniques are recommended for putting collected data in case studies in order before detailed analysis (Miles and Huberman, 1994; Yin, 2014). In essence, each policy was treated as a case study. Through each round of review and subsequent coding, differences and similarities in policies were tracked and concepts were linked into main themes. Key themes were reviewed as they developed and additional searches through the text were conducted using related keywords to see if the context changed by the regulatory agency. For example, as continuing medical education (CME) requirements were analyzed, the use of CME with professional development (competency-based medical education, continuing nursing education, continuing professional development, etc.) and role titles (e.g., provider, educator, professional, facilitator, provider, coordinator, physician) were traced. Similarly, the concepts “organization,” “system,” and “environment” were searched back to see how they were used over time, for example, in the context of policies for trainees versus licensed providers.

After reading through the policies, the following themes emerged from the supplemental literature review on policies and requirements within the regulatory organizations and agencies (see Table 11):

TABLE 11 | Policy Themes Identified in the Literature Review

• drug supply management policies,
• policies addressing patient behaviors (e.g., use of multiple providers),
• policies addressing patient health (e.g., treating patients with a prior history of opioid use, treatment visits),
• continuing medical education requirements,
• rules related to pain management clinics,
• opioid prescribing guidelines,
• doctor shopping laws,
• PDMPs,
• naloxone access laws, and
• policies affecting opioid addiction treatment.

States with an authorizing statute but no active PDMP were coded as not having a PDMP.

RESULTS

Respondents

A total of 66 individuals responded on behalf of their organizations. For four organizations, two individuals responded concomitantly, leaving a total of 62 unique organizations responding to the survey. Duplicates for these four surveys were deleted for the quantitative analysis after ensuring the responses were concordant; however, comments from both respondents were retained for qualitative review.

Table 12 provides an overview of the types of responding organizations. Respondents could choose more than one category.

NOTE: Please see Appendix E for more information on each type of organization.

The “Other” category includes four membership organizations, three testing organizations, and one local governmental organization. Most of the accrediting and certifying bodies worked predominantly at the national level while all licensing bodies were state level.

TABLE 13 | Health Care Professional Type by Jurisdiction

Health Professions

Table 13 provides a breakdown of the health professions included by national or state-level jurisdiction.

National organizations were well represented in the survey. For example, all the accreditors involved in physician education responded to the survey. The data from state-level organizations are a subset of all health professions licensing bodies in the United States. Of note is the large proportion of non-physician organizations, representative of the overall U.S. health care system. Table 13 also stands in contrast to the literature review on practice gaps where the bulk of the studies focused on physicians, highlighting the need to broaden the focus of future studies of clinical practice in pain management and substance use disorder.

Organizational Focus

The focus of the responding organizations spanned the spectrum from the individual practitioner to institutional entity (e.g., university or professional school, health care delivery institution, continuing education provider). Despite the sampling strategy, the survey did capture relevant categories of organizational focus among regulators. Table 14 provides the breakdown of the organizational focuses among respondents. Respondents could choose more than one focus area.

TABLE 14 | Organizational Focuses

Requirements

The two main questions from the survey focused on pain management and SUD, and read as follows:

1. Does your organization currently have requirements/standards for health care professionals (students, residents, fellows, or practicing health care professionals) that address acute and chronic pain management?
2. Does your organization currently have requirements for health care professionals (students, residents, or practicing health care professionals) that address SUDs?

Table 15 provides the overall proportion of organizations with requirements in these two domains who responded to the survey.

TABLE 15 | Requirements by Focus Area

In both domains, the majority of organizations surveyed did not have requirements. The requirements vary depending on the role of the organization in the overall heterogeneous system that includes licensing, certification, and accreditation, and whether the organization is a private entity versus a public regulatory agency. The requirements ranged from including specific questions on examinations, educational activity requirements (e.g., CME credits), and standards around the teaching of the domains and mandating specific amounts of continuing education in both of the domains. Specifically, when requirements existed, certifiers were likely to include questions on examinations, accreditors to specify mandates around the need for curriculum in the domain, and licensing entities to mandate some form of continuing education.

Acute and Chronic Pain Management

Even though 53 percent of organizations questioned self-reported that they did not have standards to address acute and chronic pain management, all 50 states have standards (laws, policies, regulations, and/or guidelines) for medical professionals around controlled substances. (Davis; Federation of State Medical Boards Pain Management Policies Board-by-Board Overview) Twenty nine respondents that noted they do not have standards to address acute and chronic pain management are state-affiliated licensing or certifying boards across nursing, pharmacy, and allied dental health. While these organizations may not have any standards directly set in place that does not mean they do not have to adhere to the policies of the states. Twenty-three states and the District of Columbia (DC) have requirements, either in policy, regulations, or board guidelines for medical practitioners to obtain a certain number of continuing education hours in one or more of the following areas: prescribing controlled substances, pain management, and identifying SUDs. Twenty-seven states do not have these policies in place and leave it up to the state health professions licensing board while some other states mandate the training by statute. Again, organizations that do not have policies in place for the medical populations that they govern does not mean that there are no policies in force. Of note, the survey was distributed in 2019 while the state policy analysis was performed in 2020. It is possible some changes had occurred at the state level after the respondents completed the survey or that the respondents were simply unaware of their state policies. While we cannot make definitive conclusions, a reasonable hypothesis emanating from these findings may be the need for better education within regulatory organizations regarding their evolving policies.

State laws regulating pain management clinics may impose supervision or oversight requirements over providers. A July 2019 article from JAMA pointed out that at least six states with high opioid use rates also have substantial work restrictions that restrict NPs from prescribing medications to treat OUDs (Spetz et al., 2019).

The Comprehensive Addiction and Recovery Act of 2016 (Pub L No. 114-198), while not explicitly mentioned by the participants in the survey, addresses professional standards for health care professionals in pain management, the use of electronic databases, and continuing education for medical professionals around pain and chronic pain management.

Table 16 provides an overview of the number of health professions organizations and specific stage of training or practice that have requirements in place for treating acute and chronic pain.

Substance Use Disorder (SUD)

Organizations with requirements for treating SUDs appeared to use common program requirements (e.g., accreditation), rules on prescribing practices, and general guidelines for recognizing and working with people who have SUD. Of those who do have standards around SUD, five organizations target students, four target residents and fellows, seven target practicing health care professionals

regarding continuous professional development and/or education, three target credentialing of practicing providers, and finally, seven involve licensure.

Many accreditation organizations do not have these requirements because they refer to state guidelines.

There also appeared to be some confusion as to whether the survey was asking about substance use for professionals or substance use for patients. For example, the New Hampshire Office of Professional Licensure and Certification responded to the following in the open response area: “The New Hampshire Health Professionals Program is a program available to all NH licensed physicians, physician assistants, dentists, pharmacists, and veterinarians who are experiencing difficulties with: depression, anxiety or other mental health issues alcohol, drugs, or other substances of abuse professional burnout or work-related conflict stress related to a bad outcome or malpractice claim marital or family life matters.”

Other organizations, such as the National Commission on Certification of Physician Assistants (NCCPA) and the Florida Board of Nursing, made similar comments.

Policy Review

Table 17 depicts the total policies that were submitted by the organizations that participated in this survey—21 were policies addressing chronic pain management and 20 were policies addressing SUDs. Only one policy document was not considered in the final review because it was a policy specifically for providers who possess a SUD. A complete table of policies is included in Appendix E.

Table 18 provides a sum of each area of policy provided by survey participants. Policies could touch on multiple areas of SUDS, chronic pain management, and education for providers.

The following sections provide an overall summary of the evidence evaluating each area of policy. As is detailed later in this report, these policies have different outcomes and vary greatly from organization to organization. All the policies provided shared at least one characteristic with another policy in this review and there were significant overlaps in policies that address patient behavior and health. Many of these policies provided are meant to be used in combination with other policies. Professional society guidelines, while generally not legally enforceable, do educate their members on state statutes by working with state medical boards. All the policies provided by those who completed the survey referenced other policies from both the federal and state level. Due to the nature of this analysis, those referenced policies were not included.

TABLE 17 | Count of Policies by Category

TABLE 18 | Focus and Type of Policy by Organization Category

Policies Addressing Patient Behavior

Several health care regulatory organizations have implemented risk reduction initiatives aimed at addressing patient behavior. The policies identified by survey respondents on patient behavior varied depending on whether the policies addressed drug use, misuse, dependence, initiation, or health care use. Policies also varied between use of prescription drugs as directed and prescription drug misuse or abuse. Four state licensing entities have statutes that specifically outline how to provide treatment for patients who have OUD related to prescription drugs.

Every state licensing board and regulatory agency that replied to the survey asks providers to consult PDMPs to help determine and monitor patient behavior before prescribing opioid analgesics. All states also have requirements for counseling patients on opioid use before writing a prescription. The State of Louisiana is the only state that responded to the survey that asks clinicians working in emergency departments to consult with PDMPs before prescribing opioid analgesics to admitted patients. All the accrediting bodies who responded to the survey have guidelines around provider education when treating patients with a history of SUD (e.g., opioids and alcohol). The Board of Dental Examiners of Alabama and Commission of Dental Accreditation had further requirements for providers who are actively treating patients who have SUDs or family histories of addiction.

Five of the policies submitted and reviewed were written to address patient health outcomes, such as health care professionals providing non-opioid options during their consultations, transition of care guidelines, or guidelines for talking to patient families or caregivers about opioid use. Other behavioral policies include Good Samaritan Overdose Prevention statutes, data use policies for providers, and guidelines for community health clinics. Good Samaritan drug overdose laws “provide immunity from arrest, charge, or prosecution for drug possession or paraphernalia when individuals who are experiencing or witnessing an overdose summon emergency services.”

Policies Addressing Patient Health

The policies addressing patient health delineate governmental administrations and privately operated organizations, such as accreditors. In the current literature, state policy seems to focus on addressing proper prescription of opioids while national accreditors have written policies that address more general patient concerns. For example, while a state’s regulatory authority may have a particular interest in reducing addiction and mortality caused by overdose or prescription opioid use, a national accreditor may have an interest in developing policies around reducing addiction and mortality caused by both prescription and illicit opioid use.

Regardless of the organization, there are four similarities in policies that are worth noting:

1. the facilitation and development of community health programs;
2. the encouragement of providers to use combination drugs (e.g., prescribing buprenorphine and naloxone to decrease possible misuse of opioids) for the management of OUD, increasing Medicaid recipient access to non-opioid treatment, reducing negative side effects of prescriptions (including those related to inappropriate opioid/benzodiazepine prescribing), and reducing disparities in utilization;
3. the use of referral programs; and
4. the use of alternative pain management methods for acute and chronic pain management.

Continuing Medical Education Requirements

All but three organizations that responded to the survey had guidelines for provider training in pain management and/or controlled substance prescribing as a condition of obtaining or renewing their medical license or to specialize in pain management. However, CME requirements differ between organizations and their areas of jurisdiction. Accrediting bodies only provided content guidelines for CME. These same accrediting bodies either created their own best practices before the release of the CDC guidelines for opioid prescriptions in 2016, or subsequently responded to the release of the guidelines by incorporating foundational components addressing key decisions encountered during clinical pain management (Dowell, Haegerich, and Chou, 2016).

All state-level licensing bodies have CME requirements for pain management or controlled substances that mandate providers receive postgraduate training in opioid prescribing, addiction, and/or related topics. Only the state of Vermont, the state of Florida, and the Alaska State Board of Nursing had requirements for all their prescribers, regardless of training, to obtain periodic CME/CE on topics such as pain management, controlled substance prescribing, or SUDs. However, these requirements represent a small fraction of the total required CME. For example, the Alaska State Board of Nursing has a minimum requirement of 30 hours of continuing education (CE) with only 2 hours in opioids, pain management, and OUD. The state of Florida has a two-hour mandatory training requirement (e.g., online educational module, other continuous professional development) for authorized prescribers in Florida, including physicians (MD and DO), dentists, podiatrists, and optometrists. Physician assistants and APRNs are excluded from this requirement due to the fact they must take a 3-hour mandatory course on safe and effective prescribing of opioids to maintain licensure.

Similar CME requirements apply to providers who are licensed to prescribe or dispense controlled substances, including providers working in Michigan, Utah, and Vermont. There are variations in these requirements as well. For example, Vermont requires Drug Enforcement Administration registered physicians who prescribe controlled substances receive 2 hours of CME training every 2 years on prescribing controlled substances and 1 hour of CME on hospice pain management or palliative care. The Florida and Texas State Boards of Nursing require providers who practice in pain management clinics or with certain populations to obtain CE in pain management or controlled substance prescribing. Finally, all the state licensing and certifying bodies who responded to the survey impose CME requirements based on a provider’s licensure type, practice setting, or patient characteristics. Two states (Florida and Oklahoma) have requirements specific to osteopathic physicians. Appendix C provides the CME requirements by state for physicians and Appendix D provides the requirements for nursing.

Doctor Shopping Laws

Anti-doctor shopping policies among those who responded to the survey were extremely limited in scope and scale. Only two organizations provided policies that mention doctor shopping laws of the nine respondents who mentioned the existence of doctor shopping policies. All mentioned legal provisions that include licensing penalties or criminal sanctions for the following: patients seeking opioids from multiple providers, patients having their prescriptions filled at more than one pharmacy, patient collusion, and non-reporting by patients regarding their doctor shopping. All nine policies included information regarding the use of PDMPs to track patients receiving prescriptions from five or more providers.

Drug Supply Management Policies

All 29 policies provided by those who completed the survey on drug supply management were state statutes that were supported through the Drug Supply Chain Security Act (DSCSA) and Medicaid state

laws and policies. These policies include regulatory actions (e.g., medication plan protocols) and state statutes that affect private and/or public regulation of opioids. State law fluctuates around rates of prescribing opioids and states have different laws around the prescribing of pharmaceuticals. The policies provided in this survey mostly covered patient safety, drug compounding, drug supply chain security, and laws governing drug transactions in pharmacies.

All of the policies provided by survey respondents had components that limit opioid prescriptions by restricting the quantity and/or dosage or by imposing prior authorization requirements. Ten state licensing boards directly require prescribers to use a PDMP program before prescribing opioids to patients. For example, Michigan’s DSCSA state statute asks prescribers and pharmacists to consult a PDMP before prescribing or dispensing opioids to patients.

Naloxone Access Laws

All three policies submitted from licensing boards around overdose education and naloxone distribution were geared toward primary care providers and pharmacists and all were passed in 2018 or 2019. The naloxone laws submitted include the elimination of legal and financial barriers for patient access to naloxone (i.e., creating wider insurance coverage), Good Samaritan laws, and educational programs for providers to learn about naloxone distribution and overdose treatment. All three policies allowed for the distribution of naloxone by a pharmacist over the counter to a patient without a prescription and all three policies were operating in states that permit over-the-counter sales of syringes.

Opioid Prescribing Guidelines

There was significant variation in the policies evaluated around opioid prescribing guidelines. All policies submitted included treatment guidelines for acute pain management, management of pain in the context of terminal illness or at the end of life, and the management of chronic pain not due to a malignancy. State and professional organizations have issued clinical guidelines for the use of opioids (initiating, monitoring, and dosing) in each of these categories. The issuance of these guidelines is accompanied by patient education, community outreach, and CME to foster implementation.

PDMPs

Seven state licensing boards had requirements for the use of PDMPs. Because states regulate the practice of medicine and the licensure of physicians within their borders, each state had different requirements for practitioners. These programs are all administered by law enforcement agencies in conjunction with the state licensing boards. Prescribers, including nursing assistants, residents, and nurse practitioners all have access to PDMP data for their patients. All seven states are permitted to share their PDMP data with other state PDMPs and with authorized users in other states. All state licensing boards

had weekly reporting requirements for licensed prescribers. Alaska, Delaware, Florida, and Utah have state statutes mandating mental health and substance use professionals to submit patient information to a PDMP database. Only one state—Oklahoma—had real-time PDMP reporting as of April 2017.

Policies Affecting Opioid Addiction Treatment

Due to the limited number and variation in the policies evaluated, systematic evaluation of the similarities and differences in policies around opioid addiction treatment is not possible. All five policies submitted by those who completed the survey referenced the CDC Guidelines for Prescribing Opioids for Chronic Pain, but they seemed to have different interpretations of those guidelines. Delaware, Florida, and Louisiana all had policies and procedures that outlined guidelines for OUD. The State of Alaska referenced the use of Project ECHO (Extension for Community Healthcare Outcomes) to increase provider training and build treatment capacity for SUDs in rural areas and for patients who do not have direct access to traditional treatment programs. The program connects health care providers in rural areas with specialists at a central hub via teleconferencing technology to provide support in patients’ care management (UAACHD, n.d.).