An opioid is a medication which is designed to relieve pain by reducing the intensity of pain signals that reach the emotional control centers of the brain.1 Opioids include hydrocodone, oxycodone, morphine, codeine and other similar drugs.2 In 2010, 2.4 million Americans used a prescription drug for a non-medical purpose for the first time.3 By 2014, the latest data available from the National Survey on Drug Use and Health, 6.5 million Americans over the age of 12 were using psychotherapeutic drugs, like opioids, for non-medical reasons each month.4 The use of heroin in general has mirrored that increase during the same time period, and the abuse of prescription opioids is the number one cause of new instances of heroin use.5 In January 2016, Drug Enforcement Administration (DEA) officials described the “opioid overdose epidemic” as the “most pervasive drug issue of the day.”6
This Special Edition of the ABA Health eSource addresses some of the most pressing legal and related issues involving the opioid epidemic gripping the nation. We hope that you find it helpful.
Introduction to the Legal Environment
Controlled Substances Laws and Regulations
The Controlled Substances Act (CSA) regulates the use of controlled substances, including opioids.7 The DEA controls the amount of every Schedule I and II controlled substance that is produced each year in the United States.8 Controlled substances are categorized into five schedules.9 Substances containing a “high potential for abuse” and that have “no currently accepted medical use” are listed in Schedule I.10 Heroin is a Schedule I controlled substance. Controlled substances that have “a currently accepted medical use” but also have “a high potential for abuse” are listed in Schedule II.11 Hydrocodone and morphine are listed in Schedule II. A central focus of the CSA is to prevent controlled substances from being diverted from their proper use to illegal ones.12
Any person, business or other entity that wants to prescribe or dispense a controlled substance has to first register with the DEA. Approximately 1.4 million practitioners, both prescribers and dispensers, were registered with the DEA as of December 2014, according to the most recently available data.13 A registrant must meet certain criteria, such as maintaining accurate records and adequate supplies of controlled substances as required by applicable federal and state regulations.14
Practitioners and Pharmacists
Practitioners, such as doctors and dentists, are permitted to prescribe opioids only in the “usual course and scope of their professional practice” and only for “a legitimate medical purpose.”15 Pharmacists have a responsibility to “ensure that the prescription was issued in the usual course of professional treatment for a legitimate purpose.”16
Opioids and their Relationship to Heroin Addiction
Pain treatment is a historically controversial issue in medicine, and the issues of modern day treatment of pain management are no different. Often, seemingly helpful medications or procedures at one point ultimately proved to be harmful, such as treatment by cocaine, heroin, chloroform, and bleeding patients. Opioids are going the same way – year in and year out more research shows the proliferation of prescription opioids has caused addiction levels to increase and illegal heroin use to rise.17
Compounding the problem is that many non-opioid alternative treatments are not covered by insurance. In combination with more emphasis being placed on reducing opioids, insurers have also limited non-narcotic pain intervention techniques, such as compounded topical prescriptions, nerve blocks, support braces, radio-frequency ablation, and the like.18 Moreover, the DEA announced October 4, 2016 that it is reducing the amount of opioids to be manufactured in 2017.19
When those addicted to opioids are suddenly cut off from pain medicine (either from insurance cut-offs or doctor-imposed limitations), addiction treatment, and alternative therapies, something has to give. All too often this results in patients first doctor shopping (i.e., looking for a doctor to write a prescription when another won’t), resorting to a “pill mill” doctor (i.e., one who blindly prescribes what the patient asks for without evaluating medical necessity), black-market purchase of opioids, and sometimes, ultimately, heroin use, which some have described with the often over-used term “epidemic.” For those that do become addicted to heroin, the American Society of Addiction Medicine says that four out of five “new” heroin users were first misusing prescription pain medicine.20
Law Enforcement’s Response
Collaboration of DEA, State Law Enforcement and State Regulators
The DEA has specialized groups knows as Tactical Diversion Squads, comprised of Special Agents, Task Force Officers and Diversion Officers.21 These Diversion Squads utilize data analytics to search for suspicious or aberrant prescribing patterns through state Physician Prescription Monitoring Program (PMP) databases to identify targets to investigate. These Diversion Squads also utilize traditional intelligence gathering methods, such as confidential sources, and other criminal targets that can infiltrate and provide information on prescribers and dispensers who are willing to prescribe or dispense controlled substances outside the scope of professional practice. Cases involving Schedule II controlled substances, like hydrocodone, carry substantial penalties.22 One gram of hydrocodone is treated equally to 6,700 grams of marijuana in the federal sentencing scheme. The DEA’s Office of Diversion Control has been successful in the prosecution of dozens of doctors engaged in such “pill mill” practices.23
When criminal charges are not brought, federal and state prosecutors can pursue civil sanctions against practitioners and dispensers under the CSA and/or the False Claims Act.24 These sanctions can include the loss of prescribing privileges or exclusion from federal healthcare benefit programs. The DEA maintains a list of administrative actions taken against its registrants from 2000 to 2016.25
Licensure and Regulatory Enforcement
Every state has various licensing bodies for doctors, pharmacists, nurses and other healthcare professionals. Many states permit these boards to employ investigators. Some states even credential licensing board investigators as law enforcement officers.27 These investigators routinely team up with federal and state Diversion Squads during criminal and civil investigations. When a prescriber or dispenser is confronted by the DEA, these licensing investigators are often present to contemporaneously present demand for the immediate surrender of the professional license. Information obtained in these cooperative investigations is frequently shared with the state licensing boards, and is used against the practitioner in that arena, as well.
The Fight Goes Beyond Law Enforcement
As the opioid epidemic has come into focus over the last few years, the DEA, state and local law enforcement have increased their efforts at battling unlawful behavior related to opioid misuse. Yet this is not the only legal avenue that the nation can take; other legal steps are being explored to combat the epidemic.
6 Statement of Louis J. Milione, Deputy Assistant Director, Office of Diversion Control, Drug Enforcement Administration, before the Committee on the Judiciary, United States Senate, January 27, 2016.
7 Statement of Diane C. Maurer, Director, Homeland Security and Justice, Government Accountability Organization, before the Committee on the Judiciary, United States Senate, June 22, 2016, citing Pub. L. No. 91-513, tit. II, 84 Stat. 1236, 1242-84 (codified as amended at 21 U.S.C. §§ 801-890, 901-971). “Controlled substance” is defined in the CSA as “a drug or other substance, or immediate precursor, included in one of five classification schedules.” The schedules reflect whether a substance has a currently accepted medical use and also take into account the potential and likelihood of abuse and of causing dependence.
18 http://www.businessinsider.com/doctors-insurance-companies-policies-opioid-use-2016-6 (last visited Sept. 13, 2016). Many reasons have been given to justify non-coverage of alternative treatment. Some justifications are rooted in a belief that it just doesn’t work.
20 Opioid Addiction 2016 Facts & Figures, asam.org/docs/default-source/advocacy/opioid-addiction-disease-facts-figures.pdf (last visited Sept. 13, 2016). See also various statistics from the National Institute of Drug Abuse, America’s Addition to Opioids: Heroin and Prescription Drug Abuse, https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2016/americas-addiction-to-opioids-heroin-prescription-drug-abuse (last visited Sept. 13, 2016), which suggests that as opioids become less available, heroin use increases.
23 http://www.deadiversion.usdoj.gov/crim_admin_actions/doctors_criminal_cases.pdf (last visited Sept. 13, 2016). See also Cases Against Doctors, found at https://www.deadiversion.usdoj.gov/crim_admin_actions/doctors_criminal_cases.pdf. (last updated March 31, 2016).
24 Any claim for benefits submitted to a federal healthcare benefit program as a result of a fraudulently obtained prescription being filled would violate the False Claims Act. Title 31, United States Code, Sections 3729-3733.