The recent closure of a southern Maine pain management and addiction recovery practice, along with the physician’s indictment, have prompted concerns among Maine opioid prescribers. This Client Alert summarizes the current state of affairs, and provides some general guidance for prescribers about staying in compliance with applicable laws and rules.
Background
As most Maine health care providers are aware, in response to the opioid overdose crisis, Maine has adopted statutes and rules that closely regulate the prescribing of opioids and certain other controlled substances. The most important legislation governing opioid prescribing (P.L. 2015, Chapter 488, amended by P.L. 2017, Chapter 213) inserted substantially identical requirements in the licensure statutes for nurse practitioners, osteopaths, medical doctors, physician assistants, podiatrists, veterinarians, and dentists; the statute governing the Prescription Monitoring Program (“PMP”) was also amended to reflect the new opioid prescribing requirements. Those statutory requirements were reflected in state agency rules, primarily the Maine DHHS Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications and Joint Rule 21, Use of Controlled Substances for Treatment of Pain, of the Board of Licensure in Medicine, the State Board of Nursing, the Board of Osteopathic Licensure, and the Board of Licensure of Podiatric Medicine.
These rules establish “Principles of Proper Pain Management” and “Universal Precautions” that include (i) evaluation and risk assessment; (ii) developing a treatment plan; (iii) engaging in periodic reviews; (iv) obtaining consultations or referrals when appropriate; (v) assuring coordination of care; and (vi) obtaining and documenting informed consent. To comply with these rules, prescribers must maintain an Opioid Medication Prescribing Policy, prescribe opioid medications electronically, include detailed information on opioid prescriptions, and check the PMP. Unless an exemption applies, opioid prescriptions are limited to a seven-day supply for acute pain, a 30-day supply for chronic pain, and 100 Milligrams Morphine Equivalent (“MME”) daily.
The exemptions to the prescribing limits are prescriptions for:
Pain associated with active and aftercare cancer treatment, when the prescriber documents that the pain is directly related to the patient’s cancer or cancer treatment;
Palliative care in conjunction with a serious illness (discussed in more detail below);
End-of-life and hospice care;
Medication-assisted treatment for a substance use disorder;
A pregnant individual with a pre-existing prescription for opioid medications in excess of the 100 MME aggregate daily limit (but only during the pregnancy);
Acute pain, for an individual with an existing opioid medication prescription for chronic pain (limited to a seven-day prescription);
Patients actively tapering off opioid medications, up to a maximum of six months;
Patients prescribed a second opioid medication after proving unable to tolerate a first opioid medication, thus causing the patient to exceed the 100 MME daily limit, provided that the individual prescriptions must not exceed 100 MME each.
The exemption to the prescribing limits for palliative care for a serious illness was controversial when initially adopted, as there was disagreement about whether chronic pain, by itself, could qualify as a “serious illness.” Ultimately, however, the Legislature resolved this issue by amending the statute to clarify that it does. However, when the prescribing limits will be exceeded for 90 days or more on the basis of treatment for chronic pain, the prescriber and the patient must enter into a written agreement for treatment (sometimes informally referred to as a “narcotics contract”), under which the patient agrees to various measures to limit the risk of overdose or diversion (including random drug screens and/or pill counts).
Recent Activity
The New England Prescription Opioid Strike Force was announced June 29, 2022, as a federal-state law enforcement initiative for Maine, New Hampshire, and Vermont based on the Appalachian Regional Prescription Opioid Strike Force, which has pursued “pill mills” and various other illegal opioid distribution schemes. According to its mission statement:
The mission of the NEPO Strike Force is to identify and investigate health
care fraud schemes in the New England region, and to effectively and
efficiently prosecute individuals involved in the illegal distribution of
prescription opioids and other prescribed controlled substances. The NEPO
Strike Force will primarily target criminal conduct by physicians, pharmacists,
and other medical professionals, focusing upon both health care fraud and
drug diversion offenses, as relevant based upon the facts of the particular case.
The first publicly reported activity of the NEPO Strike Force occurred October 26, 2022, when it announced the arrest and indictment of a physician in Kennebunk, Maine. The indictment (which, it should be noted, is only an allegation for the time being), included ten counts of violating the Controlled Substances Act. The prescriptions at issue were for only three patients, and included prescriptions for Oxycodone, Adderall, Klonopin, Valium, Dilaudid, and Methadone (or their generic equivalents). Of concern to prescribers, the indictment stated that these prescriptions were “not issued for a legitimate medical purpose.”
However, that wording is common in criminal prosecutions under the Controlled Substances Act, 21 U.S.C. § 841(a)(1), which makes it unlawful for any person “knowingly or intentionally” to manufacture, distribute, or dispense a controlled substance, except “as authorized” – i.e., pursuant to a valid prescription. Federal regulations provide that to be effective, a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a). Accordingly, the wording of the indictment simply tracks the wording of the regulation. See, e.g., Ruan v. United States, 597 U. S. ____ (2022).
In Ruan, the United States Supreme Court held that in a Controlled Substances Act case, the government must prove, beyond a reasonable doubt, not only that the prescriber dispensed or distributed a controlled substances not “as authorized” (i.e., not for a legitimate medical purpose), but also that the prescriber acted “knowingly or intentionally.” Further, the “knowing or intentional” lack of a legitimate medical purpose is based on the prescriber’s subjective state of mind, and is not determined by what a “reasonable” prescriber would have done under the circumstances.
To avoid potential criminal liability under the Controlled Substances Act, therefore, it is important to show good faith by documenting the medical purpose for the particular prescription, especially if it does not clearly meet the Maine dosage and duration limits discussed above. While complying with the Maine statute and rules may not necessarily be a complete defense under the Controlled Substances Act, it provides important evidence that the prescribing practices are “as authorized” for a legitimate medical purpose.
Further Guidance and Resources
New guidance from the U.S. Centers for Disease Control and Prevention (“CDC”) may also be helpful in documenting a legitimate medical purpose. CDC’s Clinical Practice Guideline for Prescribing Opioids for Pain (Nov. 4, 2022) (available online at CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022 | MMWR) adopts a more flexible approach to pain management than the previous CDC Guideline for Prescribing Opioids for Chronic Pain (2016), which the new Guideline criticizes as excessively rigid and restrictive. The new Guideline asserts that prescribing limits should not be used as inflexible standards that replace clinical judgment and individualized, patient-centered decision-making. Importantly, the new CDC Guideline does not supersede the existing Maine prescribing limits; however, documented consideration of the Guideline may tend to rebut any allegation that the prescriber was “knowingly and intentionally” distributing or dispensing a controlled substance for other than a legitimate medical purpose.
Prescribers seeking additional guidance may wish to consider other available resources, including:
Center for Personalized Education for Professionals, “Prescribing Controlled Drugs: Critical Issues And Common Pitfalls” (remote learning course, available via Prescribing Controlled Drugs Courses | CPEP (cpepdoc.org);
The Schmidt Institute, “Controlled Substances Stewardship for Maine” (various programs and tools, summarized at CSS-One-Pager-2020-4.16.20.pdf (theschmidtinstitute.org); and
The Maine Medical Association Center for Quality Improvement “Learning Lab” (free online courses on safe opioid prescribing, available via Caring for ME (Safe Opioid Prescribing) – MMA-CQI Learning Lab (qclearninglab.org).
Conclusion
Maine opioid prescribers who follow the “universal precautions” described in Joint Rule 21 should not find it difficult to establish that their prescribing practices are for a “legitimate medical purpose” consistent with the Controlled Substances Act. For the most part, showing adequate compliance will generally mean staying within the prescribing limits unless an exemption applies, clearly documenting the basis for any exemptions, and establishing plans and treatment goals for patients with opioid prescriptions outside the ordinary dosage and duration limits. If a prescription to treat chronic pain will extend for more than 90 days, a written agreement for treatment is also required. Under all circumstances, maintaining current, clear, and complete documentation is critical.
We are happy to assist our health care clients in complying with best practices in opioid prescribing. Should you have questions, please contact Ben Townsend at (207) 621-4390, or via email at btownsend@kozakgayer.com.