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Review Articles

Finding your footing in a changing legal, regulatory, and public health landscape

Kulkarni, Shruti R. JD; McClughen, Daniel C. JD; Kelly, Taylor JD; Johnson, Jessica BA

Author Information
International Anesthesiology Clinics: Spring 2020 - Volume 58 - Issue 2 - p 64-68
doi: 10.1097/AIA.0000000000000271
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Pain care in the United States is at a crossroads. In an attempt to respond to the overdose crisis, federal and state governments focused heavily on measures to reduce the supply of prescription opioid medications. Some of these actions have led to unintended consequences for patients and practitioners alike. Because of these unintended consequences, some stakeholders, including members of the federal and state governments, policymakers, and members of the health care community at large, are reassessing these efforts, while focusing on a return to a more patient-centered, individualized approach to pain care. At the same time, enforcement authorities remain vigilant in investigating and prosecuting controlled medication prescribers and dispensers, with no sign of slowing down. Yet, there are measures that practitioners can take to increase prescribing confidence, manage risk, and better understand their rights.

Part I of this article provides a timely overview of government action that has greatly impacted the current state of pain care policy in the United States and explains how recent efforts may signal a reversion to a more patient-centered approach to treatment. Part II describes various actions that may be taken by regulators and law enforcement, and explains broadly the procedures required under each type of action. Finally, Part III provides recommendations to increase prescribing confidence and manage risk.

Part I: recent federal and state health efforts regarding treatment of pain

The Centers for Disease Control and Prevention (CDC) released their well-publicized Guideline for Prescribing Opioids for Chronic Pain (the Guideline) in 2016.1 The Guideline was intended for use by primary care clinicians who prescribe opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care to improve the safety and effectiveness of pain treatment, while reducing the risks of opioid use disorder, overdose, and death.

Despite the Guideline’s intended scope, the document’s recommendations on limits on dosage and duration of opioid prescriptions were adopted widely by state and federal governments, industry, and professionals. At least 33 states have codified the Guideline’s duration and dosage limitation recommendations in some manner, and some insurers and pharmacy benefit managers have also incorporated these recommendations into their policies.2–6 Since publication of the Guideline, some clinicians have indicated that they feel pressure not to prescribe opioids, to reduce dosages, or to fully taper patients off of opioids, even if patients are stable on their treatment plans.7 Recently, there has been increasing concern that the Guideline has been misinterpreted and consequently misapplied in practice.

Federal response

In March 2019, 300 medical experts, including 3 former White House drug czars, sent a letter to the CDC to express concern about the devastating effects that the misapplication of the Guideline had on patients.8 Shortly thereafter, on April 9, 2019, the US Food and Drug Administration (FDA) warned that a sudden discontinuation of treatment with opioids can cause withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.9 That same day, Douglas Throckmorton, MD, the Deputy Director for Regulatory Programs at the Center for Drug Evaluation and Research, issued a statement reaffirming the FDA’s dedication to striking a balance between “reducing the rate of new addiction by decreasing excessive exposure to opioids” and “enabling appropriate access to treatment for patients living with serious pain.”10

The Pain Management Best Practices Inter-Agency Task Force (Task Force),11 authorized by the Comprehensive Addiction Recovery Act of 2016, published its final report on May 9, 2019 to evaluate and propose updates to best practices and issue recommendations that address gaps or inconsistencies for managing chronic and acute pain.11,12 The Pain Management Best Practices Inter-Agency Task Force was convened by the US Department of Health and Human Services in partnership with the US Department of Veterans Affairs and the US Department of Defense. The Task Force consisted of a wide variety of federal and nonfederal representatives including experts from the fields of pain management, pain advocacy, addiction, recovery, SUDs, and mental health; patients; representatives from veteran service organizations, the addiction treatment community, and groups with expertise in overdose reversal, including first responders, medical boards and hospitals. The report highlighted the need for individualized, patient-centered care in the diagnosis and treatment of acute and chronic pain. It addressed the underlying barriers to appropriate pain management and treatment, including the stigma of living with pain; the underutilization of risk assessment; the need for improved education about pain conditions and their treatments; and barriers to access to care, such as inadequate insurance coverage.12 It emphasized that pain management should utilize a multimodel approach that includes medications, nerve blocks, physical therapy, and other approaches in designing a treatment plan for each patient.12

The report also provided a review of the 2016 CDC Guideline. The report explained that although the Guideline had contributed to the mitigation of unnecessary opioid exposure, it had also been misinterpreted and misapplied. The Guideline was intended to be a recommendation; yet, over time, it has been interpreted as a mandate to initiate involuntary tapering or immediate discontinuation of opioid-based treatment, which has been linked to an increase in suicide and increased illicit drug use.12

The authors of the Guideline then published an article in the New England Journal of Medicine in June 2019 that acknowledged that “some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations.”13 Such policies include inflexible application of dosage and duration thresholds, policies that encourage hard limits and abrupt tapering of dosages, sudden discontinuation or dismissal of patients, or application outside of the scope of the Guideline.13

In October, the US Department of Health and Human Services (HHS) published the HHS Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics.14 The new HHS Guide explains that opioid prescribing changes, including dose escalation, dose reduction, and discontinuation of long-term opioid analgesics “have the potential to harm or put patients at risk if not made in a thoughtful, deliberative, collaborative, and measured manner,” and the decision to taper opioids and the rate at which opioids are tapered should be based on a patient’s unique needs and integrated into a patient’s individualized treatment plan.14 In addition, it explained that clinicians should “[a]void insisting on opioid tapering or discontinuation when opioid use may be warranted,” emphasizing that “[t]he CDC Guideline for Prescribing Opioids for Chronic Pain does not recommend opioid discontinuation when benefits of opioids outweigh risks.”14

The US Surgeon General published a series of tweets summing up the need to reexamine pain care in the United States, stating that we must “reset the discussion on pain management and opioid misuse” and “stop swinging the pendulum to extremes,” while explaining the need to strike a balance between minimizing the risk of opioid misuse and not compromising access to treatment for individuals who would benefit from opioid analgesic therapy.15 In addition, Senator Bill Cassidy recently sent a letter to the Drug Enforcement Administration (DEA) that emphasized the importance of ensuring that patients with chronic pain continue to have access to necessary and appropriate pain management medication. The letter expressed concern over the misapplication of the Guideline and commended the Task Force’s final report as a resource to “better equip the DEA and other key stakeholders while seeking to combat the opioid crisis.”16

State response

Some states have also started taking action so as to not compromise access to appropriate treatment for pain in an effort to respond to the drug overdose crisis. In May 2019, the Oregon Health Evidence Review Commission unanimously voted to delay the implementation of a controversial forced tapering policy for Medicaid patients until additional studies are completed.17 Moreover, in July 2019, the New Hampshire Board of Medicine fined a practitioner for cutting back a patient’s prescription opioid painkillers for the treatment of chronic pain, “which led to increased pain and anxiety, and suicidal ideations.”18

Part II: enforcement efforts

Although policymakers at the federal and state levels are showing signs of reverting back to a more individualized, patient-centered approach to pain care, the US Department of Justice (DOJ) continues to use “every criminal, civil, and regulatory tool possible to target, prosecute, and shut down” the individuals and organizations whom it has found to be responsible for the overdose crisis.19

DOJ, with the assistance of the Federal Bureau of Investigation (FBI) and DEA, and state law enforcement authorities, has engaged in several “surges” over the past 2 years that have led to hundreds of arrests. Since 2017, these efforts have been supported by DOJ’s Opioid Fraud and Abuse Detection Unit, a data analytics program that analyzes prescribing and dispensing data to identify suspicious patterns and practices. Based in part on these data, DOJ may investigate and prosecute practitioners who the agency believes may have contributed to the overdose epidemic. This can be problematic, however, given that pain care specialists often are presented with difficult-to-treat patients who cannot obtain adequate care elsewhere. For many of these patients, opioids or other controlled medications may be the most appropriate course of care and, as a result, some legitimate prescribers may appear as suspicious “outliers” based on prescribing data alone.

Much of DOJ’s enforcement activity on the ground is conducted by DEA agents stationed across the country. Actions by DEA agents may include engaging in administrative inspections, criminal searches, raids, and formal investigations; issuing orders for practitioners to show cause for why their registrations should not be revoked and orders to immediately suspend DEA registrations; and seeking voluntary surrenders of DEA registrations to dispense controlled medications.19–25

DEA’s enforcement authority is based on a complex, often confusing set of federal laws and regulations. Depending on the type of action taken by DEA, the agency may need to satisfy certain procedural elements, which can affect practitioners’ rights. Therefore, it is imperative that DEA-registered practitioners be aware of the basic principles underlying DEA enforcement, understand their rights, and know when it may be necessary to engage legal counsel.

Administrative inspections

DEA agents have the authority to conduct administrative inspections for the purpose of inspecting, copying, and verifying the correctness of records, reports, or other documents required by the Controlled Substances Act (CSA).26 DEA conducts inspections for cause, and routine inspections to assess ongoing compliance with the CSA.27DEA agents may attempt to conduct an inspection unannounced and without an administrative inspection warrant. As a general rule, the practitioner’s consent is required for a warrantless inspection unless otherwise permitted under DEA regulations.28,29 “A warrant under this section shall not be required for the inspection of books and records pursuant to an administrative subpena issued in accordance with section 876 of this title, nor for entries and administrative inspections (including seizures of property)—(1) with the consent of the owner, operator, or agent in charge of the controlled premises; (2) in situations presenting imminent danger to health or safety; (3) in situations involving inspection of conveyances where there is reasonable cause to believe that the mobility of the conveyance makes it impracticable to obtain a warrant; (4) in any other exceptional or emergency circumstance where time or opportunity to apply for a warrant is lacking; or (5) in any other situations where a warrant is not constitutionally required.” If a regulatory exception does not apply, the practitioner has the right to withhold consent and request that the DEA agent obtain an administrative inspection warrant.30

DEA agents can obtain an administrative inspection warrant from a judge upon a showing of probable cause.31 Here, probable cause is defined as “a valid public interest in the effective enforcement of [DEA regulations] to justify administrative inspections of the area, premises, building, or conveyance, or contents thereof, in the circumstances specified in the application for the warrant.”31 The standard for probable cause during an administrative inspection is lower than for a criminal investigation because the intrusion into an individual’s privacy is less than that in the criminal context and is outweighed by the public’s interest in the regulatory program.32–36 Although probable cause traditionally has been understood to involve some level of individualized suspicion of wrongdoing, administrative inspections are not premised on the existence of such a suspicion.37 Instead, administrative inspections are reasonable searches that are “neither personal in nature nor aimed at the discovery of evidence of a crime.”38,39

Criminal investigations

Although an administrative inspection is generally broad, routine, and noncriminal in nature, a criminal investigation is specific in nature and intended to uncover criminal activity based on suspicious conduct.37,40 A criminal investigation involves the process of legally gathering evidence to determine if a crime has or is being committed.

DEA can conduct criminal investigations if it believes that controlled substances are not being prescribed, administered, and dispensed in accordance with applicable laws and regulations. In such cases, DEA agents must follow very specific rules of criminal procedure, and will typically work closely with state and local law enforcement officials.41 As a general rule, DEA agents must obtain a search warrant from a federal judge to search the property of a practitioner pursuant to a criminal investigation.42

A judge will only issue a warrant upon a showing of probable cause, which means that based on the totality of the circumstances, there is a substantial basis or fair probability to conclude that a search would uncover evidence of wrongdoing.43 As such, to establish probable cause, law enforcement must be able to point to objective circumstances that would lead a reasonable person to believe that evidence of a crime will be found.44

Registration revocations and immediate suspension orders (ISOs)

DEA may also commence administrative actions to revoke a DEA registration.41 To revoke a DEA registration, the agency must find that the registrant has committed an act that would render the DEA registration inconsistent with the public interest.45 Before revoking a registration, DEA must issue an order to show cause that contains the basis for the revocation and provide an administrative hearing within 30 days.46 Registrants may request a hearing through DEA’s Office of Administrative Law Judges, or allow for the DEA Administrator to issue a final decision.47

However, if DEA believes that a registered practitioner poses an imminent threat to the public health or safety, an agent may obtain an ISO and require an immediate shutdown without first holding a hearing.48 This immediately impacts the practitioner’s ability to deliver care. In conjunction with an ISO, DEA will serve upon the practitioner an order to show cause.48 This allows the practitioner an opportunity for a hearing to show why his or her registration should not be suspended or revoked; however, the practitioner’s registration will remain suspended under the ISO until the case is resolved.47

Voluntary surrenders

DEA agents may request a voluntary surrender of a practitioner’s DEA registration.49 DEA treats a voluntary surrender of a registration “as an immediate termination of the DEA registration at issue” without an order to show cause, a hearing, or any other proceedings.50 Therefore, it is immediately effective upon a DEA agent’s receipt of a signed form and does not require any further action on the part of the DEA agent. An individual who voluntarily surrenders his or her DEA registration waives the right to an administrative hearing or appeal.51

Practitioners are not required to sign a voluntary surrender form. However, doing so can have immediate adverse consequences, including loss of privileges to prescribe controlled substances, possible disciplinary action against other professional licenses, possible action to revoke any national certifications, exclusion from the federal Medicare program, exclusion from the state Medicaid program, and termination from the panels of any health insurers or managed care plans of which he or she is a member.52

Part III: practice recommendations

Misapplication of the Guideline and heightened scrutiny and enforcement by federal regulators has left many health care practitioners wary of prescribing controlled medications or even accepting patients with legitimate pain. Practitioners can increase prescribing confidence and reduce the risk of liability by ensuring that their practices have established comprehensive and effective compliance plans that use reasonable measures to determine legitimate medical need as supported by thorough documentation. These practices are vital for managing risk in a rapidly evolving legal and regulatory landscape. In addition, practitioners need to understand their rights in the event of a DEA inspection or investigation and when it may be necessary to engage legal counsel.

Compliance plans

In light of the recent surge in DOJ enforcement actions and the inherent risks associated with controlled substances, health care practitioners that prescribe controlled medications should implement and regularly update internal compliance plans to ensure medical need and patient safety, reduce risk of harm, and comport with applicable state and federal laws, regulations, and policies. For instance, DEA regulations require that a prescription for a controlled medication “be issued for a legitimate medical purpose by an individual acting in the usual course of professional practice.”53

As such, compliance plans should establish protocols to help practitioners determine whether patients are suitable for treatment with controlled medications. In addition, plans should help ensure that each practitioner acts in a manner that is consistent with a “reasonable, prudent practitioner” (ie, in the ordinary course of professional practice), which includes exercising a level of caution before prescribing that would be used by a reasonable practitioner acting under similar circumstance.54–56 As explained below, practitioners should thoroughly and accurately document all actions taken to show that they have acted in accordance with these standards.

Appropriate measures should be taken not only before initially prescribing a controlled medication but also throughout the course of treatment to verify ongoing medical need and continually evaluate whether the patient shows signs of risk of abuse, misuse, or overdose; whether the medications prescribed could have unsafe drug-drug interactions; and to monitor ongoing treatment plan compliance.

In developing a compliance plan, practices should engage experienced health care counsel who can ensure that written policies and procedures are tailored to the specific needs of the practice. Compliance plans should be evaluated continuously to ensure that policies and procedures are enforced and any necessary internal improvements or changes in law or the standard of care are reflected in the plan. To effectively put a compliance plan into action, training should be provided to employees on a reasonably frequent basis to ensure understanding of policies and procedures, the laws and regulation upon which they are based, and any substantive updates to the plan.

Thorough and accurate documentation

Health care practitioners who prescribe controlled medications must ensure that thorough and accurate patient records are kept. Creating and maintaining such records is not only imperative for mitigating risk to patients’ health and safety but also legal risk for practitioners. Even if a practitioner strictly issues controlled medications “for a legitimate medical purpose … in the usual course of professional practice” in every instance, there is little that the practitioner can do to prove compliance with this standard without thorough documentation.53

As such, documentation may include, but not be limited to, evidence of conducting physical and mental health exams; establishing a diagnosis; reviewing the patient’s medical history; screening for past and current problematic substance use; checking prescription drug monitoring program (PMDP) databases; explaining the risks, benefits, and alternatives to controlled medications; administering random urine-drug tests; enquiring about the treatment’s impact of the patient’s quality of life; and speaking with other practitioners who have treated the patient, consistent with state and federal patient privacy laws and regulations.

Practitioners should also carefully document their rationale for establishing or adjusting a treatment plan. For instance, if a qualitative drug test presents evidence of noncompliance, the practitioner should document the test results and what he or she did to respond to them, such as counseling the patient, confirming the test result with a more specific technology, or increasing monitoring (eg, pill counts, more frequent visits).

Thorough documentation is particularly critical if a practitioner deviates from the medical standard of care, as the records can be used to show that the practitioner individualized the treatment plan on the basis of the patient’s unique medical needs. To this end, every patient’s record should be customized to reflect his or her unique case. Practitioners generally should avoid copying and pasting notes, as duplicative notes could be used to support an argument that the practitioner did not adequately review the treatment plan, adjust it on the basis of the circumstances, or verify ongoing medical need. In the event that regulators begin an investigation, proper documentation is vital to a successful defense.

Practitioner rights

Finally, as explained in Part II, the topic of enforcement action can be complex, varied, and confusing for practitioners. As a result, some practitioners may not fully understand their rights or when to engage counsel in the event of an inspection or investigation. Similarly, they may not fully appreciate the significant consequences to providing consent in certain circumstances when not required to do so, such as signing a voluntary revocation form or authorizing a warrantless search. As such, in addition to having a strong compliance plan, offices need to implement a training program whereby practitioners are educated on types of enforcement actions, practitioner rights and responsibilities, and when to engage counsel.

Conflict of interest disclosure

The authors declare that they have nothing to disclose. The authors are employees of DCBA Law & Policy LLP in Washington, DC. DCBA’s clients include health care providers, device and drug manufacturers, and not-for-profit organizations. To avoid conflicts of interest, DCBA adheres to the District of Columbia Rules of Professional Conduct.

References

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26. 21 U.S.C. § 880 (2012).
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28. 21 C.F.R. § 1316.08 (2019).
29. 21 U.S.C. § 800 (2012).
30. 21 C.F.R. § 1316.08 (2019).
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33. 21 C.F.R. § 1316.10 (2019). (stating that administrative probable cause shall not mean criminal probable cause as defined by Federal statute or case law).
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39. Black v. Village of Park Forest, 20 F. Supp. 2d 1218, 1228 (N.D. Ill. 1998) (Citing Camara v. Mun. Court of San Francisco, 387 U.S. 523, 537 (1967)).
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42. Fed. Rule Crim. P. 41.
43. Illinois v. Gates, 462 U.S. 213 (1983).
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45. 21 U.S.C. § 824 (2012).
46. 21 C.F.R. § 1301.37 (2019).
47. US Department of Justice. The Drug Enforcement Administration’s adjudication of registrant actions. 2014. Available at: https://oig.justice.gov/reports/2014/e1403.pdf. Accessed October 30, 2019.
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49. 21 C.F.R. §§ 1301.52(a) (2019).
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54. Gilbert v. Sycamore Mun. Hosp., 622 N.E.2d 788, 795 (Ill. 1993) (describing the standard of care as “the authority which a reasonably prudent person, exercising diligence and discretion, in view of the principal’s conduct, would naturally suppose the agent to possess”).
55. McPherson v. Ellis, 287 S.E.2d 892, 895 (N.C. 1982), (describing the standard of care as “exercis{ing} reasonable care and diligence in the application of his knowledge and skill to the patient’s case; and he must use his best judgment in the treatment and care of his patient … He is held to the standard of professional competence and care customary in similar communities among physicians engaged in his field of practice.”).
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