Toward a Typology of Office-Based Buprenorphine Treatment Laws: Themes from a Review of State Laws

Abstract

Objectives:

Buprenorphine is a gold standard treatment for opioid use disorder (OUD). Some US states have passed laws regulating office-based buprenorphine treatment (OBBT) for OUD, with requirements beyond those required in federal law. We sought to identify themes in state OBBT laws.

Methods:

Using search terms related to medications for OUD, we searched Westlaw software for state regulations and statutes in 51 US jurisdictions from 2005 to 2019. We identified and inductively analyzed OBBT laws for themes.

Results:

Since 2005, ten states have passed a total of 181 OBBT laws. We identified the following themes: 1) provider credentials: state licensure for OBBT providers and continuing medical education requirements; 2) new patients: objective symptoms patients must have prior to receiving OBBT and exceptions for special populations; 3) educating patients: general informed consent requirements, and specific information to provide; 4) counseling: minimum counselor credentials, minimum counseling frequency, counseling alternatives; 5) patient monitoring: required prescription drug monitoring checks, frequency of drug screening, and responses to lost/stolen medications; 6) enhanced clinician monitoring: evidence-based treatment protocols, minimum clinician-patient contact frequency, health assessment requirements, and individualized treatment planning; and 7) patient safety: reconciling prescriptions, dosage limitations, naloxone co-prescribing, tapering, and office closures.

Conclusions:

Some laws codify practices for which scientific consensus is lacking. Additionally, some OBBT laws resemble opioid treatment program and pain management regulations. Results could serve as the basis for a typology of office-based treatment laws, which could facilitate empirical examination of policy impacts on treatment access and quality.

INTRODUCTION:

Rates of opioid use disorder (OUD) have been rising in the US¹. Buprenorphine, a gold standard treatment for OUD², decreases the risk of opioid overdose^3,4, return to drug use^5,6, and incidence of communicable diseases^7,8. Unlike methadone, another effective treatment, buprenorphine can be prescribed in office-based settings. Unfortunately, despite calls to increase buprenorphine treatment access, current estimates show fewer than 40% of individuals in the US with OUD receive any medication for OUD, including buprenorphine^9–11. Underutilization of buprenorphine is influenced by a range of patient, provider, health system and community factors, as well as enactment, implementation, enforcement, and funding of state and federal policies^12–16.

US federal law requires certain providers of office-based buprenorphine treatment (OBBT) to obtain a waiver from the Drug Enforcement Agency (e.g., if the clinician is not a physician; if the physician treats more than 30 patients with buprenorphine at a time)¹⁷. Federal law also requires OBBT clinicians to adhere to patient limits and have access to ancillary counseling¹⁸. Federal law first enabled OBBT after the Drug Addiction Treatment Act (DATA) of 2002 and has changed several times since.^18–20.. Compared to federal laws^21,22, state laws affecting OBBT have received less attention, despite potential impact on OBBT treatment, with most state law work focused on the Medicaid-enrollees^15,23,24. Yet state laws outside Medicaid may also substantially affect OBBT access and quality.

Federal law originally prevented states from prohibiting OBBT if a prescriber adhered to DATA requirements, but that federal law provision has expired¹⁸. As a result, states can now create laws more but not less restrictive than DATA and its associated federal regulations. For example, federal law requires OBBT providers to have the capacity to refer clients to counseling¹⁸, but state laws can take this a step further by requiring OBBT providers to ensure clients receive counseling.

To better understand the full range of state laws likely to influence OBBT, and as an early step toward developing a comprehensive typology of OUD treatment laws²⁵, we examined and identified themes in OBBT laws not specific to the Medicaid population from 2005–2019 in 50 US states plus the District of Columbia. This review can contribute to a more comprehensive understanding of the legal landscape influencing OBBT and quality, and facilitate future studies related to the implementation, funding, and enforcement of OBBT policies..

METHODOLOGY:

To identify themes in OBBT laws, we systematically reviewed and analyzed statutes and regulations (hereafter, defined as state laws) in all US states and the District of Columbia. We chose to focus only on state laws specific to buprenorphine treatment, because buprenorphine is regulated uniquely as compared to other Schedule III controlled substances. We focused on the office-based setting given its importance for expanding OUD treatment access, particularly through primary care providers²⁶. Since each state approaches supervision and licensure differently for non-physician practitioners, we focused on laws regulating physician OBBT.

Data Collection:

Using terms designed to capture laws related to medications for opioid use disorder (MOUD) (e.g., buprenorphine, methadone, naltrexone) (Appendix A), we searched the Westlaw archives for regulations and statutes, including repealed laws, from 2005 through 2019. Our search yielded 14,951 laws across these 51 jurisdictions. For some jurisdictions, laws were missing for some years prior to 2012 (Appendix B).

To focus our analyses on state laws regulating OBBT, we excluded the following types of laws during the preliminary search: definition sections of laws; laws that do not regulate treatment of OUD (e.g., laws regulating treatment of pain with opioid analgesics); general licensing requirements for clinicians not specific to MOUD; laws regulating professionals who do not treat OUD (e.g., veterinarians, optometrists); laws not applicable to the entire state (e.g., only applicable to certain counties); laws creating task forces; laws regulating detoxification rather than maintenance treatment; and generic pharmacy dispensing laws not specific to MOUD. For the years 2005–2019, a total of 5,333 laws remained across 51 jurisdictions after exclusions.

Data Analysis:

Using Dedoose software²⁷, two researchers independently reviewed each law to ascertain whether its content met all of the following criteria: a) the law included an explicit reference to OUD treatment with buprenorphine in an office-based setting (Table 3), b) applied to all buprenorphine treatment practitioners in the state (i.e., not only those funded by Medicaid), and c) were not a mere restatement of federal law.

TABLE 3:

EXAMPLES OF OFFICE-BASED BUPRENORPHINE TREATMENT DEFINITIONS IN STATE LAW

State	Years Applicable	Citation	OBOT Definition
Kentucky	2019	908 Ky. Code § 1:374	Office-based Opiate Treatment Services. (1) Excluding methadone-based treatment, a facility shall be licensed as an outpatient AODE that provides office-based opiate treatment (OBOT) services if: (a) Any individual with ownership interest in the facility is not a Kentucky-licensed physician; and (b) The facility employs or has an affiliation with a physician or advanced practice registered nurse who prescribes products containing buprenorphine or other FDA-approved drugs for the treatment of opioid use disorder to fifty (50) percent or more of the facility’s patients.
North Carolina	2005 – 2019	10A N.C. Code § .0102	The term “office-based opioid treatment” means any controlled substance listed in Schedules III-V dispensed for the maintenance or detoxification treatment of opioid addiction or for the detoxification treatment of opioid dependence.
Ohio	2018–2019	4723 Ohio Code § 9-13	“Office-based opioid treatment” or “OBOT” means medication-assisted treatment of opioid dependence or addiction utilizing controlled substances, in a private office or public sector clinic that is not otherwise regulated, by practitioners who are authorized to prescribe outpatient supplies of drugs approved by the FDA for the treatment of opioid addiction or prevention of relapse. OBOT includes treatment with all controlled substance drugs approved by the FDA for such treatment.
Ohio	2015 – 2019	4731 Ohio Code § 11-01	(I) “Office based opioid treatment”, or “OBOT”, means treatment of opioid addiction utilizing a schedule III, IV or V controlled substance narcotic.
Tennessee	2019	0940 Tenn. Code § 05-35-.02	“Nonresidential office-based opiate treatment facility” or “Facility” or “OBOT” is a service entity that includes, but is not limited to, stand-alone clinics, treatment resources, individual physical locations occupied as the professional practice of a prescriber or prescribers licensed pursuant to Title 63, or other entities prescribing products containing buprenorphine, or products containing any other controlled substance designed to treat opioid use disorder by preventing symptoms of withdrawal to twenty-five percent (25%) or more of its patients or to one hundred fifty (150) or more patients.
Tennessee	2017 – 2018	0940 Tenn. Code § 05-35-.02	“Nonresidential office-based opiate treatment facility” or “Facility” or “OBOT” is a service entity that includes, but is not limited to, stand-alone clinics, treatment resources, individual physical locations occupied as the professional practice of a prescriber or prescribers licensed pursuant to Title 63, or other entities prescribing products containing buprenorphine, or products containing any other controlled substance designed to treat opioid use disorder by preventing symptoms of withdrawal to fifty percent (50%) or more of its patients and to one hundred fifty (150) or more patients.
Vermont	2017 – 2019	12 Vt. Code § 5-21:3.0	“OBOT” means Office Based Opioid Treatment physician practice for prescribing buprenorphine as established by the Drug Abuse and Treatment Act of 2000. In Vermont, OBOTs are often referred to as “Spokes”. An OBOT may be a preferred provider, an individual physician practice or several physicians practicing as a group.
Virginia	2017 – 2019	12 Va. Code § 30-130-5020	“Office-based opioid treatment” or “OBOT” means addiction treatment services for individuals with moderate to severe opioid use disorder provided by buprenorphine-waivered practitioners working in collaboration with credentialed addiction treatment practitioners providing psychosocial counseling in public and private practice settings.
West Virginia	2018 – 2019	16 W.Va.C.S. § 5Y-2	“Office-based, medication-assisted treatment” means all publicly or privately owned clinics, facilities, offices, or programs that provide medication-assisted treatment to individuals with substance use disorders through the prescription, administration, or dispensing of a medication-assisted treatment medication in the form of a partial opioid agonist.
West Virginia	2016 – 2017	16 W.Va.C.S. § 5Y-2	“Office based medication-assisted treatment” means all publicly or privately owned medication-assisted treatment programs in clinics, facilities, offices or programs that treat individuals with substance use disorders through the prescription, administration or dispensing of a medication-assisted treatment medication in the form of a partial opioid agonist or other medication-assisted medication approved for use in office-based, medication-assisted treatment setting.

The final sample included only laws matching our prespecified criteria. As a result, we excluded state laws from our analysis that are applicable to a wider range of prescriptions beyond just buprenorphine, such as: prescription drug monitoring program and electronic prescribing requirements applicable to all controlled substances, continuing education requirements for all licensed physicians, and collaborative practice agreements applicable to all controlled substances. Clarity regarding to whom laws applied was obtained from New York and West Virginia’s departments of health.

After identifying OBBT laws, researchers obtained the definition sections associated with those laws from Westlaw. See Figure 1 for a schematic of the search process. A subject matter expert created a codebook based on a preliminary transcript review, and two researchers independently coded each OBBT law in Dedoose software using the codebook. Researchers could apply more than one code to each law. Researchers met to discuss the rare discrepancies in coding, negotiating until a final coding decision was reached. During this process, new codes were identified, leading to adjustments in the original codebook and recoding of previously coded laws. Researchers examined within and across codes for common themes. We identified any OBBT laws in our sample that had been repealed and examined repealed laws for themes in subject matter.

Figure 1:

Search process

RESULTS:

Between 2005 and 2019, ten states had enacted laws regulating OBBT meeting our criteria: Alabama, Florida, Indiana, Kentucky, North Carolina, Ohio, Tennessee, Vermont, Virginia, and West Virginia. Across those states, we found 181 laws that met our inclusion criteria, including definition sections. While some states had renumbered or merged sections of laws relevant to our study between 2005 and 2019, only two laws had been repealed (both in North Carolina).

Within OBBT laws since 2005, we identified the following common themes: 1) provider credentials; 2) new patients; 3) patient education; 4) counseling; 5) patient monitoring; 6) enhanced clinician monitoring; and 7) patient safety. Several themes had subthemes. Table 2 provides example laws for each theme and subtheme, with examples chosen based on clarity of text for readers from a nonlegal background. Figure 2 describes the relationship between policy themes and subthemes.

Table 2:

Sample laws

Policy theme	Subtheme	Example 1	Example 2	Citations for additional example
Definition of office-based buprenorphine treatment		OH 2019: ““Office-based opioid treatment” or “OBOT” means medication-assisted treatment of opioid dependence or addiction utilizing controlled substances, in a private office or public sector clinic that is not otherwise regulated, by practitioners who are authorized to prescribe outpatient supplies of drugs approved by the FDA for the treatment of opioid addiction or prevention of relapse. OBOT includes treatment with all controlled substance drugs approved by the FDA for such treatment.” (Ohio Admin. Code 4723-9-13 (2019))	VT 2019: ““OBOT” means Office Based Opioid Treatment physician practice for prescribing buprenorphine as established by the Drug Abuse and Treatment Act of 2000. In Vermont, OBOTs are often referred to as “Spokes”. An OBOT may be a preferred provider, an individual physician practice or several physicians practicing as a group.” (Vt. Code R. 13 140 062 (2019))
Provider credentials	Non-physician prescribers	KY 2019: “An APRN who has obtained a waiver and registration as issued by the Drug Enforcement Administration (DEA) to prescribe Buprenorphine for the treatment of Opioid Use Disorder shall complete the one and one-half (1.5) contact hours of continuing education required annually by 201 KAR 20:215, Section 5(1)(b) in addiction disorders” (201 Ky. Admin. Regs. 20:065 (2019))	OH 2018: “(B) A clinical nurse specialist or certified nurse practitioner who holds a current valid advanced practice registered nurse license may provide medication-assisted treatment, including prescribing controlled substances in schedule III, IV or V, if the clinical nurse specialist or certified nurse practitioner: (1) Complies with all federal and state laws and regulations governing the prescribing of the medication, including but not limited to incorporating into the advanced practice registered nurse’s practice knowledge of Chapter 4729. of the Revised Code, and Chapter 4731. of the Revised Code and rules adopted under that Chapter that govern the practice of the advanced practice registered nurse’s collaborating physician; (2) Completes at least eight hours of continuing nursing education in each renewal period related to substance abuse and addiction. Courses completed in compliance with this requirement shall be accepted toward meeting the continuing education requirements for biennial renewal of the advanced practice registered nurse license; and (3) Only provides medication-assisted treatment if the treatment is within the collaborating physician’s normal course of practice and expertise.” (Ohio Admin. Code 4723-9-13 (2019))	(Tenn. Code Ann. § 53-11-311 (2018))
	Physician credentials	WV 2019: “7.4.b. All physicians and physician extenders employed by the OBMAT program shall be actively licensed in West Virginia and shall have: 7.4.b.1. A minimum of one year of experience in substance use disorder treatment and medication-assisted treatment settings; or 7.4.b.2 Meet the following requirements: 7.4.b.2.A. Active enrollment in a plan of education for obtaining competence in medication-assisted treatment methods and substance use disorders that is approved by the medical director. The medical director shall certify the individual’s completion of the plan of education when, in the discretion of the medical director, it is satisfactorily accomplished; and 7.4.b.2.B. Completion of the certification, training programs or continuing education programs recommended and approved by the medical director of the OBMAT program.” (W. Va. Code § 69-12-7 (2019))	KY 2018: “(2) The physician shall successfully complete the approved educational programs required by this subsection. (a) The prescribing physician shall be a DEA-licensed prescriber of Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone and shall have obtained Buprenorphine certification through completion of a Substance Abuse and Mental Health Services Administration (“SAMHSA”) certified course. (b) For each three (3) year continuing education cycle, each DEA-licensed prescriber of Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone shall complete at least twelve (12) hours of continuing medical education certified in Category I specific to addiction medicine as part of the required continuing medical education hours set forth in 201 KAR 9:310.” (201 Ky. Admin. Regs. 9:270 (2017))
	State office-based buprenorphine treatment registration/licensure	OH 2019: “(1) Except as provided in division (B)(2) of this section, no person shall knowingly operate a facility, clinic, or other location where a prescriber provides office-based opioid treatment to more than thirty patients or that meets any other identifying criteria established in rules adopted under this section without holding a category III terminal distributor of dangerous drugs license with an office-based opioid treatment classification.” (553 Ohio Rev. Code. § 4729 (2019))	KY 2019: “Section 6. Office-based Opiate Treatment Services. (1) Excluding methadone-based treatment, a facility shall be licensed as an outpatient AODE that provides office-based opiate treatment (OBOT) services if: (a) Any individual with ownership interest in the facility is not a Kentucky-licensed physician; and (b) The facility employs or has an affiliation with a physician or advanced practice registered nurse who prescribes products containing buprenorphine or other FDA-approved drugs for the treatment of opioid use disorder to fifty (50) percent or more of the facility’s patients.” (908 Ky. Admin. Regs. 1:374 (2019))	N.C.G.S. 90-101 (2018); N.C.G.S. 14–17 (2012); (W. Va. Code § 69-12-6 (2019))
Patient monitoring	PDMP check	VT 2017: “With the exception of prescriptions written from an OTP, prior to prescribing buprenorphine or a drug containing buprenorphine to a Vermont patient for the first time and at regular intervals thereafter, and: At regular intervals thereafter, but no less than twice annually; and No fewer than two times annually thereafter; and Prior to writing a replacement prescription.” (Vermont Department of Health. Vermont Prescription Monitoring System Rule Chapter 8, Subchapter 7. Vermont Department of Health. October 1, 2015. Accessed January 20, 2021.)	KY 2019: “At least once every three (3) months, the prescribing or dispensing physician shall obtain KASPER reports to help guide the treatment plan. If the KASPER indicates any abnormal findings, the prescribing or dispensing physician shall incorporate those findings into appropriate clinical reasoning to support the continuation or modification of treatment and shall accurately document the same in the patient record.” (201 Ky. Admin. Regs. 9:270 (2017))
	Lost/stolen medications	KY 2019: “The prescribing or dispensing physician shall document a plan for handling any lost or stolen medication, which: a) Shall not provide for the automatic replacement of medication prior to the specified interval date; and b) If the prescribing or dispensing physician determines that it is necessary to minimize improper or illegal diversion of medications under the circumstances, shall require the patient to first report the lost or stolen medications to police or other law enforcement agencies.” (201 Ky. Admin. Regs. 9:270 (2017))	VT 2015: “The following professionals and entities must a with the Department to enable their access to the VPMS system: 6.2.7 Prior to prescribing buprenorphine or a drug containing buprenorphine to a Vermont patient for the first time and at regular intervals thereafter, and…Prior to writing a replacement prescription.” (Vermont Department of Health. Vermont Prescription Monitoring System Rule Chapter 8, Subchapter 7. Vermont Department of Health. October 1, 2015. Accessed January 20, 2021.)
	Call backs of medications	WV 2017: “The diversion control plan shall contain, at a minimum, a random call-back program with mandatory compliance, which shall be in addition to the regular schedule of program visits.” (W. Va. Code § 69-12-16 (2019))	VT 2018: “To ensure patient and public safety, each MAT provider shall develop clinical practices to minimize risk of diversion. These practices shall include the following…Recording the ID numbers listed on the medication “strip” packaging for matching with observation of ID numbers during random call-backs.” (Vt. Code R. 13 140 062-6 (2019))
	Buprenorphine formulation (i.e., limiting mono-product prescribing)	TN 2019: “(b)(1) Any prescription for buprenorphine mono or for buprenorphine without use of naloxone for the treatment of substance use disorder shall only be permitted to a patient who is: (A) Pregnant; (B) A nursing mother; (C) Has a documented history of an adverse reaction or hypersensitivity to naloxone; or (D) Directly administered the buprenorphine mono or buprenorphine without use of naloxone by a healthcare provider, acting within the healthcare provider’s scope of practice, for the treatment of substance use disorder pursuant to a medical order or prescription order from a physician licensed under title 63, chapter 6 or 9; provided, however, that this subdivision (b)(1)(D) does not permit buprenorphine mono or buprenorphine without use of naloxone to be dispensed to a patient in a manner that would permit it to be administered away from the premises on which it is dispensed.” (Tenn. Code Ann. § 53-11-311 (2018))	KY 2019: “(2) Buprenorphine-Mono-Product shall not be prescribed or dispensed for medically-supervised withdrawal or as a maintenance treatment for a patient diagnosed with opioid dependence, except: (a) To a pregnant patient; (b) To a patient with demonstrated hypersensitivity to naloxone; or (c) As an implant-delivered or injectable treatment administered in a physician’s office or other healthcare facility.” (201 Ky. Admin. Regs. 9:270 (2017))
	Urine drug screen frequency	OH 2016: “The physician shall require toxicological testing be performed at least monthly for the first six months, then randomly at least once every three months thereafter.” (Ohio Admin. Code 4731-11-12 (2015))	WV 2018: “All patients in the OBMAT program shall undergo monthly drug testing. Random drug testing of all patients shall be conducted during the course of treatment as required in this rule.” (W. Va. Code § 69-12-28 (2019))
Educating patients		KY 2019: “[Clinicians must] obtain written informed consent from the patient in a manner that meets professional standards.” (201 Ky. Admin. Regs. 9:270 (2017))	AL 2019: “Possible topics of discussion include the difference between addiction and physical dependence (including an explanation of why agonist therapy is not simply “switching one addiction for another”), the likelihood of relapse with and without medication-assisted treatment, the projected duration of the treatment, the potential for successfully tapering from agonist therapy at some point in the future, and the role and importance of adjunctive therapies such as counseling and peer support. With the patient’s consent, this conversation could include family members, significant other(s), or a guardian.” (Ala. Admin. Code r. 540-X-21 (2019))	(Fla. Admin. Code R. 64 B15F-14.009 (2004))
New patients	General population	WV 2019: “After thorough review of the information acquired through the initial assessment, a patient may be admitted to the OBMAT program if, using accepted medical criteria, a determination is made that one or more of the following factors is met: a) The patient is currently addicted to an opioid drug, as evidenced by a positive drug test for either opioids or methadone; b) There are objective symptoms of withdrawal, or both; or c) There is objective evidence that the patient qualifies under the provisions of this rule.” (W. Va. Code § 69-12-19 (2019))	VT 2019: “Prior to commencing MAT, and in addition to ensuring that any patient has a comprehensive medical evaluation as described in Section 6.2.1, the OBOT provider shall assess the patient and diagnose and document an opioid use disorder as defined by either the current edition of the Diagnostic and Statistical Manual of Mental Disorders, or the current edition of the International Classification of Diseases.” (Vt. Code R. 13 140 62 (2019))	(Fla. Admin. Code R. 65D-30.014 (2019))
	Requirements for special populations (e.g., pregnant women)	WV 2019: “Admission to the OBMAT program may be allowed to the following groups with a high risk of relapse without the necessity of a positive drug test or the presence of objective symptoms: The patient is a pregnant woman with a history of substance use disorder” (W. Va. Code § 69-12-19 (2019))	KY 2018: “A physician shall not prescribe or dispense Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone to a patient who is pregnant or breastfeeding unless the prescribing physician first obtains and documents consultation with another physician for an opinion as to whether the potential benefit of Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone use outweighs the potential risk of use. The consultation shall be obtained from a physician who is certified by the American Board of Addiction Medicine, the American Board of Medical Specialties (ABMS) in psychiatry, or an American Osteopathic Association (AOA) certifying board in addiction medicine or psychiatry or from an obstetrician or maternal-fetal medicine specialist who is also qualified to prescribe buprenorphine.” (201 Ky. Admin. Regs. 9:270 (2017))	(Vt. Code R. 13 140 062-6 (2019)) (201 Ky. Admin. Regs. 20:065 (2019)); (201 Ky. Admin. Regs. 9:270 (2017))
Counseling	Minimum frequency	VT 2018: “Based on the outcomes of the psychosocial assessment, the provider may recommend to the patient that he or she should participate in ongoing counseling or other behavioral interventions such as recovery programs.” (Vt. Code R. 13 140 62-6 (2019))	WV 2019: “Counseling sessions, which may be conducted via telehealth, shall be provided according to generally accepted best practices and shall be offered: At least weekly during the first 90 days of treatment; At least twice per month during the remainder of the first year of treatment; and Thereafter, counseling sessions shall take place as indicated in the patient’s individualized plan of care or treatment strategy.” (W. Va. Code § 69-12-23 (2019))	(201 Ky. Admin. Regs. 9:270 (2017))
	When counseling is not feasible	VT 2018: “A provider may not deny or discontinue MAT based solely on a patient’s decision not to follow a recommendation to seek counseling or other behavioral interventions unless the patient is otherwise non-compliant with program expectations. (12 Vt. Code R. 13 140 062 (2019))	OH 2019: “When clinically appropriate and if the patient refuses treatment from a qualified behavioral healthcare provider, community mental health services provider, or community addiction services provider, as defined in rule 4731-33-01 of the Administrative Code, the physician shall ensure that the OBOT treatment plan requires the patient to participate in a twelve step program or appropriate self-help recovery program. If the patient is required to participate in a twelve step program or self-help recovery program, the physician shall require the patient to provide documentation of on-going participation in the program .” (Ohio Admin. Code 4731-33-03 (2019))	(Ohio Admin. Code 4731-11-12 (2019))
	Mandatory counselor credentials	WV 2019: “Any unlicensed or uncertified counseling staff employed or used on a referral basis by the program shall be directly supervised by a licensed or certified professional or advanced alcohol and drug counselor, or both. At a minimum, the supervisor shall provide at least one hour of supervision per 20 hours of direct service. Supervision may be group in nature, but must consist of case consultation and discussion or clinical training rather than administrative oversight.” (W. Va. Code § 69-12-17 (2019))	OH 2019: “If the physician providing OBOT is a board certified addictionologist, psychiatrist, or board certified psychiatrist, the physician may personally provide behavioral health services for addiction.” (Ohio Admin. Code 4731-33-03 (2019))	(Ohio Admin. Code 4731-11-12 (2019))
	Communication between buprenorphine provider and counselor	FL 2019: “The physician shall pursue a team approach to the treatment of opioid addiction, including referral for counseling and other ancillary services. Ongoing communication between the physician and consultants is necessary to ensure appropriate compliance with the treatment plan. This may be included in the formal treatment agreement between the physician and patient.” (Fla. Admin. Code R. 64D-30.014 (2019))	OH 2019: “If the physician refers the patient to a qualified behavioral healthcare provider, community addiction services provider, or community mental health services provider, the physician shall document the referral and the physician’s maintenance of meaningful interactions with the provider in the patient record.” (Ohio Admin. Code 4731-33-03 (2019))
Enhanced clinician monitoring	Frequency of clinician-patient contact	OH 2019: “(a) During the first ninety days of treatment, the physician shall prescribe no more than a two-week supply of the buprenorphine product containing naloxone. (b) Starting with the ninety-first day of treatment and until the completion of twelve months of treatment, the physician shall prescribe no more than a thirty-day supply of the buprenorphine product containing naloxone.” (Ohio Admin. Code 4731-33-03 (2019))	KY 2018: “The prescribing or dispensing physician shall ensure that the patient is seen by the physician: (i) No later than ten (10) days after induction and then at intervals of no more than ten (10) days for the first month after induction; and (ii) At intervals of no more than fourteen (14) days for the second month after induction. (i) If the patient demonstrates objective signs of positive treatment progress, the prescribing or dispensing physician shall ensure that the patient is seen at least once monthly thereafter. (ii) If two (2) years after initiation of treatment, the patient is being prescribed Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone for opioid dependence and the patient has demonstrated objective signs of positive treatment progress, including documented evidence that the patient has been compliant with the treatment plan and all treatment directives for at least two (2) years, then the prescribing or dispensing physician may require that the patient be seen only by the prescribing or dispensing physician at least once every three (3) months.” (201 Ky. Admin. Regs. 9:270 (2017))
	Individualized treatment plan	WV 2019: “The individualized plan of care or treatment strategy shall be reviewed by the program physician, primary counselor and patient at least every 90 days and documented in the patient record. A revised plan of care or treatment strategy may be implemented with each review. After one year of successful treatment, the individualized plan of care or treatment strategy shall be reviewed annually, or more often based on the program physician and primary counselor’s discretion and updated as appropriate.” (W. Va. Code § 69-12-25 (2019))	FL 2019: “The written treatment plan shall state objectives that will be used to determine treatment success, such as freedom from intoxication, improved physical function, psychosocial function and compliance and shall indicate if any further diagnostic evaluations are planned, as well as mental health and/or substance abuse counseling, psychiatric management or other ancillary services including development and compliance with a recovery program. This plan shall be reviewed periodically. After treatment begins, the physician shall adjust drug therapy to the individual medical needs of each patient.” (Fla. Admin. Code r. 65D-30.014 (2019))
	Clinical assessment requirements	FL 2019: “Evaluation of the Patient. A recent, complete medical history and physical examination must be documented in the medical record. The medical record shall document the nature of the patient’s addiction(s), evaluate underlying or coexisting diseases or conditions, the effect on physical and psychological function, and history of substance abuse and any prior treatments.”(Fla. Admin. Code R. 64 B15F-14.009 (2004))	OH 2019: “The physician who provides OBOT shall perform and document an assessment of the patient. The assessment shall include all of the following: (a) A comprehensive medical and psychiatric history; (b) A brief mental status exam;(c) Substance abuse history;(d) Family history and psychosocial supports; (e) Appropriate physical examination; (f) Urine drug screen or oral fluid drug testing; (g) Pregnancy test for women of childbearing age and ability;(h) Review of the patient’s prescription information in OARRS; (i) Testing for human immunodeficiency virus; (j) Testing for hepatitis B;(k) Testing for hepatitis C; and (l) Consideration of screening for tuberculosis and sexually-transmitted diseases in patients with known risk factors.” (Ohio Admin. Code 4731-33-03 (2019))	(201 Ky. Admin. Regs. 9:270 (2017))
	Violation of standard of care	FL 2019: “Qualified physicians need not fear disciplinary action from the Board or other state regulatory or enforcement agency for appropriate prescribing, dispensing or administering approved opioid drugs in Schedules III, IV, or V, or combinations thereof, for a legitimate medical purpose in the usual course of opioid addiction treatment. The Board will consider appropriate prescribing, ordering, administering, or dispensing of these medications for opioid addiction to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of opioid addiction and in compliance with applicable state and federal law.” (Fla. Admin. Code R. 64 B15F-14.009 (2004))	KY 2019: “Failure to comply with or a violation of the professional standards established in Section 2 of this administrative regulation shall constitute a “departure from, or failure to conform to the standards of acceptable and prevailing medical practice within the Commonwealth of Kentucky,” in violation of KRS 311.595(12) and (9), as illustrated by KRS 311.597(4) and may constitute a violation of KRS 311.595(9), as illustrated by KRS 311.597(3), subjecting the licensed physician to sanctions authorized by KRS 311.595.” (201 Ky. Admin. Regs. 9:270 (2017))
	Treatment protocol	OH 2019: “The physician shall provide OBOT in accordance with an acceptable treatment protocol for assessment, induction, stabilization, maintenance, and tapering. Acceptable protocols are any of the following: (1) SAMHSA treatment improvement protocol publications for medication assisted treatment available from the SAMHSA website at: https://store.samhsa.gov. (2) “National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use,” approved by the American society of addiction medicine in 2015, available from the website of the American society of addiction medicine at https://www.asam.org/.” (Ohio Admin. Code 4731-33-03 (2019))	KY 2019: “The OBOT facility shall use evidence-based assessment and evaluation tools that have been peer reviewed and validated, including the most recent edition of: 1. ASAM placement criteria; 2. Addiction Severity Index; 3. Substance Abuse and Mental Health Services Administration (SAMHSA) Treatment Improvement Protocol; or 4. Any other equivalent assessment and evaluation tool.” (908 Ky. Admin. Regs. 1:374 (2019))	(W. Va. Code § 69-12-25 (2019))
Patient safety	Naloxone co-prescribing	OH 2019: “The physician who provides OBOT shall offer the patient a prescription for a naloxone kit. (1) The physician shall ensure that the patient receives instruction on the kit’s use including, but not limited to, recognizing the signs and symptoms of overdose and calling 911 in an overdose situation. (2) The physician shall offer the patient a new prescription for naloxone upon expiration or use of the old kit. (3) The physician shall be exempt from this requirement if the patient refuses the prescription. If the patient refuses the prescription the physician shall provide the patient with information on where to obtain a kit without a prescription.” (Ohio Admin. Code 4731-33-03 (2019))	IN 2019: “A health care provider that prescribes for a patient in an office based opioid treatment setting shall do and document the following: (11) Prescribe an overdose intervention drug and education on how to fill the prescription when buprenorphine is initiated on the patient.” (IN Code § 12-23-20-2 (2019))
	Involuntary termination	WV 2019: “26.1. Administrative withdrawal is an involuntary withdrawal or administrative discharge from pharmacotherapy. Administrative withdrawal should be used as a last resort after the OBMAT program exhausts all efforts to address the patient’s behavior or actions that would warrant administrative withdrawal. The schedule of withdrawal may be brief, less than 30 days, if necessary. 26.2. OBMAT programs shall develop and implement policies and procedures for the involuntary termination from treatment that includes and describes the rights of the patient and the responsibilities and rights of the program. 26.3. Administrative withdrawal may result from any of the following: 26.3.1. Non-payment of fees. The OBMAT program shall make every effort to consider all clinical data, including patient participation and compliance with treatment prior to initiating administrative withdrawal for non-payment. If the patient has a history of compliance and cooperation with treatment, the program shall document every effort to explore alternatives to administrative, withdrawal with the patient prior to onset of withdrawal. If necessary and unavoidable, the schedule of withdrawal shall follow protocols and guidelines of approved authorities. 26.3.2. Disruptive or adverse effect conduct. Disruptive conduct or behavior considered to have an adverse effect on the program, clinical staff, or patient population of such gravity as to justify the involuntary withdrawal and discharge of a patient. Such behaviors may include violence, threat of violence, dealing drugs, diversion of pharmacological agents, violation of peer confidentiality, repeated loitering, and failure to follow treatment plan objectives or noncompliance with program rules, policies and procedures resulting in an observable, negative impact on the program, staff and other patients. 26.3.3. Incarceration or other confinement. The OBMAT program may work with law enforcement and corrections personnel in order to avoid mandatory withdrawal whenever possible. 26.4. The OBMAT program shall document in the patient’s individualized plan of care or treatment strategy and chart all efforts regarding referral or transfer of the patient to a suitable, alternative treatment program. 26.5. Female patients shall have a negative pregnancy screen prior to the onset of administrative withdrawal. Patients withdrawn for not presenting to the program are not required to have a pregnancy test. A patient’s refusal to take the test shall be documented. Refer to section 29.5. of this rule for administrative withdrawal for female patients with a positive pregnancy screen.” (W. Va. Code § 69 – 12- 26 (2019))	VT 2019: “Each OBOT shall have a written plan for continuity of care in the event that a future voluntary or involuntary program closure occurs. Programs shall have an operational plan for managing a program closure; the plan shall include: A plan for the orderly and timely transfer of patients to another OBOT provider; A plan to notify patients of any upcoming closure and reassure them of transition plans for continuity of care; A plan to notify ADAP and DVHA no fewer than 60 days prior to closure to discuss the rationale for closure, and plans for continuity of care’ A plan for the transfer of patient records to another OBOT provider.” (Vt. Code R. 13 140 062-5 (2019))	(W. Va. Code § 69-12-29 (2019))
	Co-prescribing of controlled substances	KY 2019: “Except as provided in paragraph (b) of this section, Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone shall not be prescribed or dispensed to a patient who is also being prescribed benzodiazepines, other sedative hypnotics, stimulants or other opioids, without consultation of a physician who is certified by the American Board of Addiction Medicine, the American Board of Medical Specialties (ABMS) in psychiatry, or an American Osteopathic Association (AOA) certifying board in addiction medicine or psychiatry. (b) A physician may prescribe or dispense Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone to a patient who is also being prescribed benzodiazepines, other sedative hypnotics, stimulants, or other opioids, without consultation in order to address an extraordinary and acute medical need not to exceed a combined period of thirty (30) days.” ((201 Ky. Admin. Regs 9:270 (2017))	OH 2019: “Due to a higher risk of fatal overdose when buprenorphine is prescribed with other opioids, benzodiazepines, sedative hypnotics, carisoprodol, or tramadol, the physician shall only co-prescribe these substances when it is medically necessary. The physician shall verify the diagnosis for which the patient is receiving the other drug and coordinate care with the prescriber for the other drug, including whether it is possible to taper the drug to discontinuation. If the physician prescribing buprenorphine is the prescriber of the other drug, the physician shall taper the other drug to discontinuation, if it is safe to do so. The physician shall educate the patient about the serious risks of the combined use.” (Ohio Admin. Code 4731-33-03 (2019))
	Dose restrictions, including exceptions	OH 2019: “When using any oral formulation of buprenorphine, the physician shall document in the medical record the rationale for prescribed doses exceeding sixteen milligrams of buprenorphine per day. The physician shall not prescribe a dosage exceeding twenty-four milligrams of buprenorphine per day.” (Ohio Admin. Code 4731-33-03 (2019))	KY 2019: “Every twelve (12) months following initiation of treatment, if a patient’s prescribed daily therapeutic dosage exceeds the dose equivalency of sixteen (16) milligrams buprenorphine generic tablet per day and the prescribing or dispensing physician is not certified by the American Board of Addiction Medicine, the American Board of Medical Specialties (ABMS) in psychiatry, or an American Osteopathic Association (AOA) certifying board in addiction medicine or psychiatry, then the prescribing or dispensing physician shall refer the patient for consultation by a physician who is certified by the American Board of Addiction Medicine, the American Board of Medical Specialties (ABMS) in psychiatry, or an American Osteopathic Association (AOA) certifying board in addiction medicine or psychiatry for an opinion as to whether continued treatment and dosage is appropriate and shall accurately document the results of that consultation in the patient chart.” (201 Ky. Admin. Regs. 9:270 (2017))

Figure 2:

Office-Based Buprenorphine Treatment Common Policy Themes & Subthemes

A. Provider credentials

Some state laws had OBBT credentialing requirements for physicians and non-physician prescribers, such as continuing medical education above and beyond DATA waiver requirements. OBBT credential requirements for non-physician prescribers included requirements for supervision by a DATA-waivered physician, additional continuing medical education, limitations on prescribing refills, or a blanket prohibition of non-physician OBBT.

Some state laws also addressed state registration or licensing requirements for OBBT. These laws included the registration process (e.g., documentation requirements, frequency of re-licensing), potential inspections of providers/practices, exclusion criteria (i.e., who need not register), and potential disciplinary action for failure to register.

B. New patients

Some state laws dictated the types of patients for whom a clinician may provide OBBT. These laws generally fell into two subthemes: accepting patients from the general population and accepting special populations (e.g., pregnant women, recently incarcerated individuals, people who inject drugs). Laws regarding the general population typically required the clinician to assess for objective symptoms of OUD or a positive urine drug screen prior to beginning OBBT.

In contrast, laws regarding new patients from special populations allowed clinicians to forgo assessment of objective OUD symptoms or positive urine drug screens. They required clinicians to prioritize acceptance of these patients or, rarely, prohibit acceptance of a pregnant or breastfeeding woman for OBBT without first consulting another clinician. One law also specified admission timing, requiring admission of pregnant women seeking OBBT within 48 hours of the patient initially contacting the clinician.

C. Educating patients

Some state laws required clinicians to provide specific information to patients before initiating OBBT. Such laws may have simply specified that a clinician must obtain informed consent prior to treatment initiation, or they may have detailed required discussion topics, such as MOUD risks and benefits, alternative treatment options, drug testing frequency, number and frequency of refills, and potential reasons for treatment discontinuation.

D. Counseling

Some states had laws addressing co-occurring behavioral health counseling requirements, including the following subthemes: minimum frequency of required counseling; required minimum qualifications of counselors; communication requirements between counselors and buprenorphine providers; and actions for a clinician to take if counseling is infeasible for the patient.

With respect to counseling frequency, some laws required counseling at preset intervals (e.g., weekly, monthly), while others allowed the OBBT provider or counselor to determine the frequency.

Laws requiring minimum counselor credentials specified who may provide OBBT associated counseling, with some requiring a licensed mental health professional to provide the counseling, seemingly excluding physicians without behavioral health or addiction specializations. Some laws addressed communication requirements between counselors and buprenorphine providers, such as by requiring ongoing communication between these parties and collaboration in treatment decision-making.

Some state laws also specified actions for the provider to take if a patient declines to participate in counseling, such as compelling peer support group attendance instead. Other states prohibited termination of OBBT due to counseling non-adherence.

E. Patient monitoring

Laws in the “patient monitoring” theme described how providers should monitor patient adherence with treatment or otherwise promote use of medications as prescribed. Such laws included requirements for clinicians to check prescription drug monitoring programs at specified intervals, actions for clinicians to take if patients lose prescriptions (e.g., additional prescription drug monitoring program checks), random medication call back or pill count requirements, limitations on prescribing buprenorphine formulations that lack naloxone (e.g., only permitted for pregnant women), and requirements for drug screening (e.g., frequency; substances included in the screening). State laws required prescription drug monitoring program checking during OBBT at specific intervals (e.g., annually) or when certain conditions occur (e.g., a patient reports a lost prescription.)

Laws governing minimum drug screening frequency varied substantially, with one law specifying a range of drug screening frequency requirements (eight drug screens within the first year of treatment, and six drug screens annually thereafter) but another law requiring drug screening monthly for the duration of treatment..

F. Enhanced clinician monitoring

Treatment requirements not specific to counseling, patient monitoring, or patient safety, which are categorized elsewhere, were included in the enhanced clinician monitoring theme.

These laws included specified frequency of clinician-patient interaction (e.g., biweekly for initial 90 days, and monthly thereafter), health assessment requirements (e.g., assessment types and frequency, requirements for individualized treatment plans based on assessments), treatment protocols, and potential clinician disciplinary action. Clinical assessment laws detailed types of assessments to be performed at treatment initiation or throughout treatment, including physical and psychological assessments for OUD, co-occurring mental health disorders, and other co-occurring health conditions (e.g., HIV/AIDS.). Protocol laws specified the type of protocol to be followed, such as American Society of Addiction Medicine guidelines or SAMHSA’s Treatment Improvement Protocol. Potential disciplinary action for failure to adhere to the minimal standard of care included referral to the state licensing board and civil financial penalties.

G. Patient safety

Patient safety laws stipulated actions providers should take to prevent patient return to drug use or overdose, such as co-prescribing naloxone to OBBT patients. These laws also included standards for involuntary treatment termination, such as tapering protocols and transitioning patients to new buprenorphine providers in preparation for office closure. Furthermore, some state laws specified reasons considered insufficient for terminating a patient, such as polydrug use or non-adherence to counseling requirements.

Some states specified actions for OBBT providers to take if patients are concurrently prescribed benzodiazepines or other controlled substances by another provider, including communicating with the prescriber of the controlled substance or consulting with an addiction medicine specialist. Finally, some patient safety laws specified buprenorphine dosage limitations (e.g., 16 mg), as well as exceptions to dosage limitations, such as following an addiction specialist consultation.

DISCUSSION

Among 50 US states and the District of Columbia, we found ten states with OBBT laws between 2005 and 2019. Across these state laws, we found several common themes: required provider credentials; new patients; patient education; counseling; patient monitoring; enhanced clinician monitoring; and patient safety. Several of these common themes included laws that, if enforced, could influence patient access to or quality of care, with some potentially acting as a barrier to access.

The themes we identified raise three concerns. First, some laws codified medical practices for which a strong evidence base is lacking. Second, some types of state laws resembled those regulating opioid treatment programs (OTPs), even though a goal of DATA was to provide buprenorphine in a less stringent regulatory framework than that of OTPs²⁸. Third, some types of state laws resembled pain clinic laws, which were designed to prevent inappropriate opioid analgesic prescribing for chronic pain²⁹ even though buprenorphine treatment of OUD is safer and has a stronger evidence base than does opioid analgesic treatment of chronic pain^2,30. As we describe below, laws resembling those found in OTPs or pain clinic laws could have a negative impact on clinician supply..

Codifying medical practices in state law is potentially concerning, especially if codified practices lack a strong evidence base. For example, we identified a counseling theme in OBBT laws which included specific counseling frequency requirements (e.g., weekly or monthly). However, a recent systematic literature review found mixed results regarding the effectiveness of adding counseling to buprenorphine treatment³¹. Counseling requirements may limit patient access to buprenorphine treatment, especially if few qualified counselors exist nearby or accept Medicaid³². Similarly, the enhanced clinician monitoring theme includes laws requiring a specified frequency of mandatory office visits. However, we are unaware of evidence regarding the “appropriate” frequency of patient visits, presumably since such need should be based on unique patient factors. Requiring a pre-specified visit frequency could put patients at risk of not having their medication if they miss an appointment and could create additional barriers for people lacking reliable transportation, working multiple jobs, or lacking reliable childcare. Therefore, codifying frequency of visits in state law should not occur without strong evidence supporting the specified frequency of interaction.

Similarly, while several state laws required diagnosing OUD prior to prescribing buprenorphine, lack of consensus exists on how best to identify patients with OUD. For example, some proportion of patients diagnosed with OUD likely do not have DSM-5-defined OUD—and do not meet diagnostic criteria—but rather demonstrate signs of aberrant opioid use or have physical or psychological opioid dependence³³. We also identified laws prohibiting clinicians from prescribing above a certain dosage of buprenorphine (e.g., 16mg) without first consulting an addiction specialist, presumably to ensure patient safety. Yet addiction specialists are not widely available³⁴, and dosage limits are not necessarily evidence-based, with one study finding higher dosages of buprenorphine more protective against hospitalization related to opioid overdose³⁵. In general, codifying medical practices in state law risks decreasing provider discretion, potentially making providers less willing to treat patients with OUD. Given the complexity of OUD cases and the vulnerability of the population, OUD treatment providers may need more rather than less discretion to address the unique needs and barriers of each patient.

We found several types of OBBT laws resembling laws regulating OTPs, such as those related to accepting new patients (e.g., objective symptoms to first identify, exceptions for pregnant women) and minimum frequencies for counseling and urine drug screening. The more state OBBT laws resemble OTP laws, the fewer the number of clinicians who may seek to provide buprenorphine in office-based settings, and the fewer the number of patients who may be interested in accessing OBBT. One can readily imagine a patient willing to take buprenorphine at home daily and participate in monthly physician visits, but unwilling or unable to participate in weekly counseling or weekly office visits. On balance, preventing such a patient from accessing buprenorphine treatment in office-based settings may result in more harm than good.

Relatedly, several types of state OBBT laws appeared similar to those found in pain management clinic laws, which were instituted to prevent opioid analgesic overprescribing²⁹. Such laws, such as those requiring OBBT providers to register with the state, may be unnecessary as the nation is not facing a buprenorphine overprescribing crisis. Furthermore, unlike opioid analgesics for chronic pain³⁰, buprenorphine is the standard of care for OUD². Such registration requirements may discourage clinicians from offering OBBT. For example, West Virginia’s state medical association penned a letter to the state legislature in response to such legislation, arguing physicians would opt out of offering buprenorphine in office-based settings if first required to register with the state³⁶. Despite the potential negative implications of such laws on OBBT provider supply, only North Carolina has repealed OBBT registration requirements passed since 2005.

Finally, we found several laws requiring OBBT providers to first consult with an addiction specialist or another specialist (e.g., OB/GYN) before undertaking certain actions, such as before beginning buprenorphine treatment for pregnant women or prescribing a dosage above 16mg. Such laws resemble some state opioid analgesic prescribing laws, which sometimes require primary care physicians to consult with specialist pain management physicians³⁷. Given the wider distribution of primary care providers relative to behavioral health specialists (e.g., psychiatrists)²⁶, state policies relying on specialists may reduce patient access to care.

Pregnant women were often treated uniquely within OBBT laws. For example, some states prohibited prescribing the buprenorphine mono-product (e.g., Subutex) except for pregnant women; or states required identification of objective OUD symptoms or a urine drug screen before buprenorphine treatment, except in the case of pregnant women. These laws likely reflect increasing concern with rising rates of neonatal opioid withdrawal syndrome and increasing rates of children entering the foster care system due to parental drug use³⁸. But laws requiring clinicians to obtain a second opinion when prescribing buprenorphine to pregnant women could create a treatment barrier. Buprenorphine providers are already less likely to offer a new patient appointment to pregnant women than to non-pregnant women³⁹.

The American Society of Addiction Medicine (ASAM) has voiced concerns about a number of these aspects of OBBT laws, recommending against regulatory dosage limits and licensing requirements for OBBT in a 2018 policy statement⁴⁰. Furthermore, ASAM urged states not to promulgate OBBT requirements above those in DATA, especially for clinicians treating 100 or fewer patients with buprenorphine⁴⁰.

Interestingly, of the ten states with OBBT laws, nine were in the South or Midwest, and none were in the West. Additionally, 8 of 10 states with OBBT laws were in the top 50% of states with the highest 2018 opioid overdose death rates (Table 1). Although we are uncertain of state policymakers’ rationale creating OBBT laws, it appears policymakers in some states with high overdose rates have increased their attention in recent years to buprenorphine prescribers, but enacting buprenorphine provider requirements that go above and beyond federal requirements, these policymakers may unintentionally hinder access to care.

Table 1:

Jurisdictions in analysis sample with OBBT laws, geographic regions, and overdose dose death rate rankings

Jurisdiction	Opioid overdose death rate ranking (2018)	Geographic region
West Virginia	1	South
Ohio	6	Midwest
Kentucky	12	South
Vermont	14	Northeast
North Carolina	18	South
Tennessee	17	South
Indiana	19	Midwest
Florida	24	South
Virginia	28	South
Alabama	34	South

^*Overdose death rankings are from the Kaiser Family Foundation for 2018. Kaiser Family Foundation. Opioid Overdose Death Rates and All Drug Overdose Death Rates per 100,000 Population (Age-Adjusted) for 2018. Kaiser Family Foundation. 2020. Accessed January 19, 2021. https://www.kff.org/other/state-indicator/opioid-overdose-death-rates/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Opioid%20Overdose%20Death%20Rate%20(Age-Adjusted)%22,%22sort%22:%22desc%22%7D

^**Geographic region groupings are from the US Census. The US Census Bureau. Statistical groupings of states and counties. Accessed January 19, 2021. https://www2.census.gov/geo/pdfs/reference/GARM/Ch6GARM.pdf

Our study has several limitations. We examined laws applying to all clinicians providing OBBT, regardless of payer. It is likely clinicians prescribing to Medicaid-enrollees or clinicians working in state-funded public clinics are subject to additional requirements that could further restrict OBBT access. Similarly, we excluded laws applying to only part of a state (e.g., one county). Federal laws, as well as state laws not restricted to OBBT, likely also influence OBBT, and future work identifying themes in those more heterogenous laws, building on this work, is needed. We only examined laws through 2019, and we have no information regarding 2020 laws or amendments in the context of the COVID-19 pandemic. New laws could lead to identification of additional or different themes. In our study, we focus only on state laws specific to buprenorphine prescribers in office-based settings, given the unique treatment of OBBT under federal law. As a result, we exclude laws from our analysis that are applicable to a wider range of prescriptions (e.g., other controlled substances) and treatment settings. Therefore, our themes should not be interpreted as describing the full landscape of all laws to which buprenorphine prescribers must adhere; rather, themes describe state laws unique to OBBT prescribers. Lastly, some types of laws could potentially be categorized into multiple themes which researchers should account for when creating a typology.

While surveys of state Medicaid officials identified state policies that have been previously used in empirical examinations related to buprenorphine^15,23,24, a more in-depth understanding of state laws and policies requires a thorough categorization of the types of laws, including state laws regulating OTPs and licensing/certification requirements for state-funded clinics offering buprenorphine treatment for the general population. Understanding themes in state OBBT laws is an early step toward designing a typology of state laws that could inform studies examining how state law affects OUD treatment utilization and provision. Since enactment of laws is only one aspect of understanding how such laws influence OUD treatment utilization and provision, future work should examine implementation, enforcement, funding, training, and awareness of OBBT laws.