Professional Actions Against Physicians for Opioid Prescribing Behaviors
AHLA thanks the leaders of the Physician Organizations Practice Group for contributing this feature article.
- July 01, 2021
- Gaurav J. Dhiman
- Matthew K. Casbarro , Shutts & Bowen LLP
In its landmark 2006 decision Gonzales v. Oregon, the U.S. Supreme Court recognized that Congress intended for the Controlled Substances Act to prevent physicians from engaging in the illicit trade and distribution of controlled substances, but not to regulate the practice of medicine itself, leaving that task to the states. Subsequently, there has been a greater push for the federal government to fight the opioid crisis—especially in connection with the practice of medicine. This article does not address the competing interest of federal, state, and private parties but rather discusses the laws, regulations, and guidelines pertaining to physician licensure, Drug Enforcement Administration (DEA) registration, and board certification in the context of opioid prescriptions and what actions may be taken against a physician who has failed to diligently follow such legal mandates.
Background on Opioids
Opioid molecules attach to and block opioid pain receptors on the body’s cells, controlling pain levels. Opioids may be natural or synthetic, and physicians commonly prescribe both types. The most well-known opioids include hydrocodone, oxycodone, morphine, codeine, methadone, tramadol, and fentanyl. Scientists sometimes extract necessary chemicals from the opium poppy plant directly (e.g., codeine and morphine) or synthesize them in a laboratory (e.g., fentanyl and tramadol). Synthetic opioids often are more concentrated and require a lower dosage, making them potentially more addictive. No opioid has singlehandedly driven the epidemic, and patients may take multiple types, sometimes developing a dependency on each one.
Withdrawal symptoms (e.g., muscle and bone pain, diarrhea, and vomiting) serve as indicators for further treatment. Certain medications help with treatment. For instance, the medication naloxone provides immediate benefit to patients who have overdosed, and health professionals administer it via needle solution, hand-held auto-injector, or nasal spray. Another medication for opioid withdrawal is naltrexone, which directly blocks opioid receptors and inhibits the effects of opioids. The medications methadone and buprenorphine—both opioids themselves—help with opioid treatment by activating the same receptors in the brain as other opioids, reducing withdrawal symptoms.
While fentanyl analogs have taken on a greater role in the opioid epidemic, heroin, an illicit opioid, also has seen a resurgence. Eighty percent of heroin users initially had a lawful opioid prescription, as subsequent tolerance, dependence, or addiction to otherwise legal opioids sometimes spurred patients to seek the more potent heroin. Conversely, the percent of opioid users who relied upon heroin as their first opioid before using other opioid medications, even if using the latter lawfully, increased from 9% in 2005 to 33% in 2015. In other words, although a large majority of heroin users initially had opioid prescriptions prior to their heroin usage, heroin has also increasingly become a “gateway” to other opioids.
DEA Classification of Controlled Substances
The DEA schedules controlled substances according to “whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused.” Schedule I controlled substances have a high propensity for abuse, have “no currently accepted medical use in the United States,” and have no safe administration under a physician’s supervision. Examples of Schedule I drugs are heroin, Ecstasy, LSD, and peyote. Conversely, medications that are Schedules II through V may be appropriate in medical settings. Although Schedule II controlled substances have some currently accepted medical use, they have a high chance of abuse and may lead to psychological or physical dependence. Schedule III controlled substances have lower potential for abuse than Schedule I or II controlled substances, have a currently accepted medical use, but “may lead to moderate or low physical dependence or high psychological dependence.” Schedule IV and V controlled substances have a currently accepted medical use, have even lower potential for abuse and physical or psychological dependency than the aforementioned schedules, and do not contain commonly abused opioids beyond small amounts. The non-exhaustive table below summarizes how the DEA schedules various controlled substances.
Physicians are highly trained professionals who must meet certain educational and credentialing requirements. To prescribe opioid medications, such professionals typically must have obtained a Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) degree. Still, medical school graduates must receive further training during residency in individual specialties like internal medicine, pediatrics, family medicine, general surgery, psychiatry, or anesthesiology, among others, before they can independently practice medicine. After completing residency, physicians may elect to receive further training via a fellowship in a specific sub-specialty (e.g., a pain medicine fellowship after a family medicine residency), though many physicians choose to practice with the completion of only a residency but no fellowship. Physicians who practice the aforementioned specialties may more likely encounter patients with pain needs, as opposed to, for example, physicians practicing dermatology.
Medical licenses allow physicians to practice to their full breadth of training and expertise. Initial steps toward licensure begin during medical school, when medical students take their first licensing examinations. During residency, many state governments allow physicians to apply for a medical license after at least one full year of training. This license allows these resident-physicians to practice medicine independently to an extent, even during residency, but only holds validity within the issuing state. Over their careers, physicians must renew their licenses periodically, which may have continuing education and professional conduct requirements, and may need to apply for new licenses before practicing in a different state.
State medical boards (SMBs) typically are entities within state governments that grant and renew licenses. Each state has its own SMB, often comprised of multiple physicians and subject to that state’s laws and regulations. More importantly, although medicine is a self-regulated profession, practicing medicine remains “a privilege granted by the state.” Because of that ascendancy of state powers, SMBs play a more robust role than merely granting licenses and also “investigate complaints, discipline physicians who violate the [M]edical [P]ractice [A]ct, and refer physicians for evaluation and rehabilitation when appropriate.” Each SMB’s authority arises from its state’s statutes known as a “Medical Practice Act,” by which SMBs establish and enforce professional standards of medicine, as well as from the respective state’s administrative regulations. Though regulations may further clarify or interpret statutes, SMBs have some leeway in construing and applying both. In 2017, of the 4,081 physicians across the nation whom SMBs disciplined, 686 had their licenses suspended and 248 had their licenses revoked. Consequences for serious clinical misbehavior or failure to maintain continuing standards of professionalism and technical knowledge also may include a lesser reprimand of restrictions on a license. Alternatively, physicians often can surrender their licenses before a revocation. In many scenarios, reprimanded physicians may still apply for licensure to practice in other states. Of course, a physician who violates federal, state, or local law may be open to civil or criminal prosecution (e.g., when a physician has committed a patient privacy violation under the Health Insurance Portability and Accountability Act).
SMBs often determine individual cases by “reviewing complaints from patients, malpractice data, information from hospitals and other health care institutions, and reports from government agencies” and holding hearings as deemed appropriate. Boards frequently rely upon “malpractice data as a tool to detect unprofessional conduct that may violate the Medical Practice Act. Some boards have built-in levels of malpractice that trigger investigations, such as a certain number of malpractice settlements in a certain span of time.” SMBs also often publish in online profiles a physician’s “licensure status and disciplinary history” as well as “full board orders of disciplinary actions, malpractice judgments[,] and criminal convictions.” Such information often ends up in the Physician Data Center of the Federation of State Medical Boards, which shares the information with SMBs. Though physicians are members of the public, the highly technical nature of their profession necessitates that health professionals comprise a majority of SMB membership and act as a tribunal of sorts for other physicians who fail to act appropriately or with sufficient expertise as part of their professional duty.
Physicians looking to prescribe controlled substances also must obtain a separate Certificate of Registration (COR) from the DEA, which often lasts for three years, by filling DEA Form 224—New Application for Registration. Subsequent DEA actions may stem from information based on “transaction reports from DEA-registered manufacturers and distributors, as well as reports submitted on suspicious orders and drug thefts and information shared by federal partners, such as the Department of Health and Human Services.”
Under 21 U.S.C. § 823(f), the U.S. Attorney General (AG) may deny a physician’s application or request for a modification of the physician’s COR in consideration of the “public interest,” which the AG can further determine based on five factors:
- The recommendation of the appropriate State licensing board or professional disciplinary authority.
- The applicant’s experience in dispensing, or conducting research with respect to controlled substances.
- The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
- Compliance with applicable State, Federal, or local laws relating to controlled substances.
- Such other conduct which may threaten the public health and safety.
The DEA, in looking at these factors for its public interest analysis, does not necessarily give increased weight to whether a physician properly prescribed controlled substances without past diversion to non-intended individuals. This also seemingly applies whether the physician has been practicing for a short or lengthy period of time. The agency seems to have wide latitude in choosing under which public interest factors the agency can allow sanctions, and the final determination may be more all-or-none than a weighing of the five factors. The DEA generally defers to the state standard, such as that determined by a state statute, rule, or an SMB’s opinion.
Furthermore, there are five grounds on which the AG may deny, revoke, or suspend a physician’s COR, including (1) material falsification on the COR application; (2) any state or federal felony conviction pertaining to a controlled substance; (3) suspension, revocation, or denial of the physician’s license (e.g., by the SMB); (4) inconsistency with “public interest,” as governed above by 21 U.S.C. § 823(f); or (5) exclusion from a federal reimbursement program like Medicare or Medicaid. In the event of a revocation or suspension, one aspect that the AG often weighs is whether prescriptions for controlled substances were “for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” Some other examples of DEA actions include “scheduled inspections, letters of admonition, [and] memoranda of agreement/understanding.”
Before it can revoke or suspend a COR, the DEA will serve an Order to Show Cause (OSC) to the physician, who must explain why revocation or suspension should not occur and may then request a hearing before a DEA administrative law judge (ALJ), or may waive such a hearing. In some cases, the AG may immediately suspend a COR via an Immediate Suspension Order (ISO), which may last as long as the proceedings brought against the registrant, in the event of “an imminent danger to the public health or safety.” That “imminent danger” is statutorily defined as “a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration” due to the registrant’s inability to protect against drug diversion to individuals besides the intended patients.
OSCs and ISOs are two major actions for suspending or revoking a physician’s COR; the DEA may also issue an OSC before denying an application. Instead of taking action against a physician on the whole gamut of controlled substances, the DEA may choose to do so for one or a few controlled substances. In an OSC, the DEA must allow the registrant opportunity to submit a request for a hearing before an ALJ. Correspondingly, Congress passed the Ensuring Patient Access and Effective Drug Enforcement Act of 2016. One specific provision of that law requires that in an OSC the DEA must explain its legal and evidentiary basis for its intended action and also allow a registrant to submit a corrective action plan for due consideration prior to or on the date of the ALJ hearing. Final disposition about a COR actually rests with the DEA Administrator, to whom an ALJ gives a recommended decision, although the former is not necessarily obligated to follow the latter’s legal or factual findings. While the DEA has considerable authority on how to pursue an action against a physician, a revocation or suspension of a DEA registration does not necessarily preclude a physician from practicing medicine, though an inability to prescribe controlled substances, even for a short time, may hamper her practice.
The DEA issues up to 100 decisions annually. For example, the DEA issued 178 final decisions on registration cases—out of a grand total of 505 cases—between 2008 and 2012. However, a majority of cases had settlement agreements, much in the same vein as happens in litigation, instead of requiring the final decision of an ALJ. Typically, only a single ALJ rules on each case. Some cases originate after an ISO or revocation, though the majority linger a bit longer. Notably, a DEA COR action, after exhausting the lower channels of review, can end up in the D.C. Circuit or with the circuit court of the registrant’s principal place of business, though the AG’s findings of fact often receive deference.
After finishing residency or fellowship, a physician voluntarily may apply for board certification by a certification board (CB). Nationally, there are 24 CBs under the American Board of Medical Specialties (e.g., the American Board of Anesthesiology for anesthesiologists) and 16 under the American Osteopathic Association. Physicians often have testing requirements prior to becoming board certified, as board certification indicates that “the practitioner has gone above and beyond that minimal standard [of licensure] in a particular specialty or subspecialty by way of extra education and study, and has passed a test to prove it.”
In denying a physician’s initial application for certification, CBs may consider medical license restrictions, suspensions, and revocations, and “other determination of unprofessional conduct by an appropriate authority,” such as DEA action on a physician’s COR. Physicians may face similar hurdles in recertification and may “see discipline, exclusion, or other sanction by their certification boards as a result of [a] state disciplinary action . . . where the action is one of suspension or restriction of the license or a privilege associated with the license, such as the ability to prescribe controlled substances.” Even if an SMB has not yet taken action on a physician’s license, CBs retain authority to investigate allegations on their own.
Board certification remains voluntary. As a matter of internal professional recognition, it also is not government regulated. Hence, board certification seems less essential to medical practice than licensure or DEA registration and more like a mere accolade for physicians seeking recognition of professional competency.
However, as “certification requirements can function as de facto licensure requirements, instead of optional qualitative signals,” not being board certified has ramifications. Many hospitals and clinics require board certification before bestowing admitting privileges upon physicians. Board certification is not always a prerequisite to employment as a practicing physician but is far more common than having only a medical license and no board certification. Additionally, some insurance companies require board certification to be eligible for reimbursement. Even the general public, as survey evidence suggests, has shown a preference for treatment from board certified physicians. Finally, in a medical malpractice suit, a physician-expert’s board certification can be a qualifier to serve as an expert medical witness before a tribunal.
Improper opioid prescribing behaviors may lead to actions against a physician’s license, hampering or even terminating his ability to practice medicine. Due to one of the five aforementioned grounds, including such licensure issues, a physician’s COR may be denied, revoked, or suspended. Actions on a physician’s license or DEA registration can also affect board certification with consequences for employability or reimbursement. Overall, counsel must remain cognizant of how physicians’ opioid prescribing behavior sometimes has repercussions for their medical licensure, DEA registration, and board certification.
Gaurav J. Dhiman is a recent graduate of the University of Miami School of Law. His coursework as well as professional and extracurricular activities have given him exposure to the many facets of health care law. He has also been engaged with AHLA since his second year of law school.
Matt K. Casbarro is an Associate at Shutts & Bowen LLP in Miami, FL. Matt focuses on complex commercial litigation and class action lawsuits. He has a background in science and health care, graduating with a B.A. in Biology & Society from Cornell University.
AHLA would like to thank the Physician Organizations Practice Group for contributing this feature article: Kathryn Hickner, Brennan Manna & Diamond LLC (Chair); Christopher Richard, Gilpin Givhan PC (Vice Chair—Education: Programming); Ethan Rii, Vedder Price (Vice Chair—Education: Programming); Patrick Souter, Gray Reed & McGraw LLP (Vice Chair—Education: Publishing); Adam Walters, Walters Law PC (Vice Chair—Education: Publishing); and Michael VanBuren, Calfee Halter & Griswold LLP (Vice Chair—Member Engagement).
1 See Gonzales v. Oregon, 546 U.S. 243, 269-70 (2006).
2 See Nora Volkow, How Can We Better Support Physicians in Addressing the Opioid Crisis?, Nat’l Inst. Health (Aug. 31, 2018), https://www.drugabuse.gov/about-nida/noras-blog/2018/08/how-can-we-better-support-physicians-in-addressing-opioid-crisis.
3 See Synthetic Opioid Overdose Data, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/drugoverdose/data/fentanyl.html (last visited Feb. 25, 2021) [hereinafter Synthetic Opioid Overdose Data (CDC)].
4 See Nat’l Inst. Drug Abuse, What Are Prescription Opioids?, Nat’l Inst. Health (May 2020), http://www.drugabuse.gov/publications/drugfacts/prescription-opioids [hereinafter Prescription Opioids (NIDA)].
5 See Synthetic Opioid Overdose Data (CDC), supra note 3.
6 See id.
7 See Prescription Opioids (NIDA), supra note 4.
8 See id.
9 See id.
10 See id.
11 See Letter from James L. Madara, Chief Exec. Officer, Amer. Med. Ass’n, to Deborah Dowell, Chief Med. Officer, Nat’l Ctr. for Injury Prevention & Control (June 16, 2020) (on file with the Amer. Med. Ass’n) at 1.
12 Pradip K. Muhuri et al., Associations of Nonmedical Pain Reliever Use and Initiation of Heroin Use in the United States, Ctr. Behav. Health Stat. & Quality (Substance Abuse & Mental Health Serv. Admin.) (Aug. 2013), https://www.samhsa.gov/data/sites/default/files/DR006/DR006/nonmedical-pain-reliever-use-2013.htm.
13 Theodore J. Cicero et al., Increased Use of Heroin as an Initiating Opioid of Abuse, 74 Addictive Behav. 63, 64 (2017).
14 Diversion Control Div., Controlled Substance Schedules, U.S. Dep’t of Just., https://www.deadiversion.usdoj.gov/schedules/index.html (last visited Feb. 28, 2021).
15 21 U.S.C. § 812(b)(1) (2020).
16 Id. § 812(c).
17 See Diversion Control Div., supra note 14.
18 Id. § 812(b)(2).
19 Id. § 812(b)(3).
20 Id. §§ 812(b)(4)-(5).
21 Id. § 812(c).
22 Diversion Control Div., supra note 14.
23 See Amy E. Thompson, A Physician’s Education, 312 J. Am. Med. Ass’n Internal Med. 2456 (2014).
24 See id.
25 See id.
26 See Drew Carlson & James N. Thompson, The Role of State Medical Boards, 7 Am. Med. Ass’n J. Ethics 1 (2005), https://journalofethics.ama-assn.org/article/role-state-medical-boards/2005-04.
27 See Thompson, supra note 23.
28 See id.
29 See Carlson, supra note 26, at 2.
30 See id. at 1.
31 See id.
34 See id.
35 See id.
36 See U.S. Medical Regulatory Trends and Actions 2018, Fed’n St. Med. Boards (2018) at 19, https://www.fsmb.org/siteassets/advocacy/publications/us-medical-regulatory-trends-actions.pdf [hereinafter FSMB].
37 See Carlson, supra note 26, at 2.
38 See John Fauber & Matt Wynn, 7 Takeaways from Our Year-Long Investigation into the Country’s Broken Medical License System, USA Today, Nov. 30, 2018, https://www.usatoday.com/story/news/2018/11/30/medical-board-license-discipline-failures-7-takeaways-investigation/2092321002/.
39 See id.
40 Carlson, supra note 26, at 2.
41 FSMB, supra note 36, at 8.
42 Id. at 9.
43 See id. at 8.
44 21 C.F.R. § 1301.13(d) (2020).
45 Drug Enf’t Admin., DEA Form 224—New Application for Registration (2020), https://www.deadiversion.usdoj.gov/drugreg/reg_apps/224/224_instruct.htm.
46 U.S. Dep’t of Just., Press Release, DEA Surge in Drug Diversion Investigations Leads to 28 Arrests and 147 Revoked Registrations (Apr. 2, 2018), https://www.justice.gov/opa/pr/dea-surge-drug-diversion-investigations-leads-28-arrests-and-147-revoked-registrations.
47 21 U.S.C. §§ 823(f)(1)-(5) (2020).
48 See John J. Mulrooney II & Katherine E. Legel, Current Navigation Points in Drug Diversion Law: Hidden Rocks in Shallow, Murky, Drug-Infested Waters, Marquette L. Rev. 333, 364 (2017).
49 See id. at 365.
50 See id. at 366.
51 See id. at 388.
52 21 U.S.C. §§ 824(a)(1)-(5) (2020).
53 21 C.F.R. § 1306.04(a) (2020).
54 See Press Release, supra note 46.
55 21 C.F.R. § 1301.36(d) (2020).
56 21 U.S.C. § 824(d)(1) (2020).
57 Id. § 824(d)(2).
58 21 C.F.R. § 1301.36(g) (2020).
59 Id. §§ 1301.37(c)-(d).
60 Ensuring Patient Access and Effective Drug Enforcement Act of 2016, Pub. L. No. 114-145, 130 Stat. 354.
61 21 U.S.C. § 824(c)(2)(A) (2020).
62 21 C.F.R. § 1301.46 (2020).
63 See Douglas J. Behr, Challenging an Immediate Suspension of a DEA Registration: Is It Time for a New Tact?, 69 Food & Drug Law J. 25, 26 (2014).
64 See Off. of the Inspector Gen. (U.S. Dep’t of Just.), The Drug Enforcement Administration’s Adjudication of Registrant Actions: May 2014, DOJ Pub. No. I-2014-003 (2014), at 6.
65 See id.
66 See id.
67 See id.
68 21 U.S.C. § 877 (2020).
69 See David B. Waisel, Disagreements between Medical Specialty Boards and Their Diplomates, 17 Am. Med. Ass’n J. Ethics 193, 194 (2015), https://journalofethics.ama-assn.org/article/disagreements-between-medical-specialty-boards-and-their-diplomates/2015-03.
71 Specialties and Subspecialties, AOA Board Certification, https://certification.osteopathic.org/specialties-and-subspecialties (last visited Apr. 10, 2021).
72 See Waisel, supra note 69.
73 Elaine Cox, Board Certification for Doctors: What Does It Really Mean?, US News Health (2017), https://health.usnews.com/health-care/for-better/articles/2017-04-26/board-certification-for-doctors-what-does-it-really-mean (last visited Mar. 20, 2021).
74 See Am. Med. Ass’n, Inappropriate Use of CDC Guidelines for Prescribing Opioids D-120.932 (2019), https://policysearch.ama-assn.org/policyfinder/detail/CDC%20guideline?uri=%2FAMADoc%2Fdirectives.xml-D-120.932.xml; see, e.g., Joey Berlin, Is Your Board Certification Safe?, Tex. Med. Assoc., https://www.texmed.org/Template.aspx?id=47638 (last visited Apr. 9, 2021).
75 Standards for Initial Certification, Am. Bd. Med. Specialties (2016) at 5, https://www.abms.org/wp-content/uploads/2020/11/abms-standards-for-initial-certification.pdf [hereinafter ABMS].
76 Standards for the ABMS Program for Maintenance of Certification (MOC), Am. Bd Med. Specialties (2014) at 7, https://www.abms.org/wp-content/uploads/2020/11/standards-for-the-abms-program-for-moc-final.pdf.
77 Jon M. Pellett, The 10 Biggest Legal Mistakes Physicians Make in the Collateral Consequences of Disciplinary Proceedings, SEAK Blog (2005), https://seak.com/blog/uncategorized/10-biggest-legal-mistakes-physicians-make-collateral-consequences-disciplinary-proceedings.
78 See ABMS, supra note 75.
79 See Waisel, supra note 69.
80 Daniel J. Gilman et al., Board Certification: A Dose of Competition, Health Affairs Blog (Nov. 29, 2017), https://www.healthaffairs.org/do/10.1377/hblog20171121.748789/full.
81 Cox, supra note 73; see also Joseph Low, Board Certification as Prerequisite for Hospital Staff Privileges, 7 Virtual Mentor 1 (2005).
82 See Cox, supra note 73.
83 See id.
84 See, e.g., Troyen A. Brennan et al., The Role of Physician Specialty Board Certification Status in the Quality Movement. 292 J. Am. Med. Ass’n 1038, 1043 (2004) (using data from a Gallup poll to conclude that the public values board-certified physicians and continuing board recertification).
85 33 Am. Jur. Proof of Facts 2d Qualification of Medical Expert Witness 179 § 8.3 (2006).
86 21 U.S.C. §§ 824(a)(1)-(5) (2020).