What Should I Do When I Notice Compliance Problems
The compliance problem that a practitioner identifies independently is the compliance problem for which the most constructive responses are available. The compliance problem that investigators identify first is the one for which the response is most constrained.
Self-identified compliance issues in controlled substance prescribing practices are not rare. The clinical, regulatory, and administrative requirements governing opioid prescribing are extensive, frequently updated, and not always consistently applied within a practice. A practitioner or practice administrator who reviews prescribing records, billing documentation, or controlled substance inventory with genuine attention will typically identify areas where the practice’s conduct has not met every applicable standard.
The question is not whether compliance issues exist. The question is what to do when they are identified.
Do Not Ignore Identified Compliance Issues
The practitioner who identifies a compliance problem and takes no action has documented, through the identification itself, that the problem was known. A compliance review that generates a written report identifying prescribing irregularities, documentation deficiencies, or controlled substance accounting discrepancies, but that produces no remediation, creates a record of awareness without a record of response. That record, if it reaches investigators, demonstrates that the practitioner knew of the problem and chose not to address it.
Inaction in the face of identified compliance problems is itself a form of conduct that may inform a government investigation’s assessment of the practitioner’s intent. The prescriber who identified the problem and corrected it is in a different legal position than the prescriber who identified the problem and continued prescribing in the same manner. The difference between those two positions is the compliance response.
Privilege the Review and the Findings
Compliance reviews that are conducted under the direction of counsel, and whose findings are communicated to counsel, are protected by the attorney-client privilege and the work product doctrine. A compliance review that is conducted without counsel’s involvement, whose written findings are shared with non-attorney staff, or whose conclusions are discussed in unprotected communications is a review whose findings may be discoverable by the government in a subsequent investigation.
The structure of the compliance review matters. A review directed by outside counsel, conducted by healthcare compliance professionals retained by that counsel, and whose findings are communicated to the practitioner through counsel in a privileged communication is a review whose findings are protected. The same review conducted by the practice’s own staff, without counsel’s involvement, generates unprivileged documents that the government can subpoena.
Directing compliance work through counsel is not an effort to hide findings from the government. It is the appropriate exercise of privilege rights that the legal system provides for precisely this purpose. The privilege does not protect the underlying facts. It protects the process of identifying and analyzing them with the assistance of legal counsel.
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(212) 300-5196Remediate Identified Problems
When compliance problems are identified, the appropriate response is remediation: correcting the practices that generated the problem, implementing controls that prevent the problem from recurring, and documenting the remediation in a manner that demonstrates the practitioner’s good faith response to the identified issue.
Remediation of prescribing compliance problems may include: additional training for staff on documentation requirements; implementation of more rigorous patient assessment protocols; adjustments to the practice’s controlled substance prescribing policies; termination of the prescribing relationship with patients who present signs of diversion; and enhanced monitoring of the practice’s prescribing data against PDMP records.
The practitioner who remediates identified compliance problems and documents the remediation has created evidence that, if the matter subsequently becomes the subject of a government investigation, demonstrates an affirmative good faith response to identified issues rather than an ongoing indifference to compliance obligations.
Voluntary Disclosure
In some circumstances, the proactive voluntary disclosure of identified compliance problems to the relevant government authority is the appropriate response. The OIG’s self-disclosure protocol, the DEA’s voluntary disclosure provisions, and analogous programs at state agencies provide mechanisms through which practitioners and healthcare entities can disclose identified compliance problems and seek resolution of the resulting liability before the government identifies the problem independently.
Todd Spodek
Lead Attorney & Founder
Featured on Netflix's "Inventing Anna," Todd Spodek brings decades of high-stakes criminal defense experience. His aggressive approach has secured dismissals and acquittals in cases others deemed unwinnable.
Voluntary disclosure is not appropriate in every situation, and it is not without risk. A disclosure that reveals conduct the government had not yet identified may initiate an investigation that would not otherwise have occurred. A disclosure that is incomplete may be treated as worse than no disclosure at all. The decision about whether to make a voluntary disclosure, and what to disclose, requires careful analysis of the identified conduct, the available defenses, and the likely government response.
The compliance problem identified in an internal review is a problem that exists regardless of whether it is addressed. The choice is not between having the problem and not having it. The choice is between addressing it now, with the full range of available responses, or addressing it later, with whatever responses remain after the investigation has progressed beyond the point where early intervention was possible.
When Compliance Problems Suggest a Larger Issue
Some compliance problems identified in an internal review suggest a pattern that goes beyond individual documentation deficiencies or administrative oversights. A review that reveals systematic prescribing of controlled substances to patients without adequate physical examination documentation, controlled substance inventory discrepancies that exceed the range attributable to accounting error, or a pattern of prescriptions that do not correlate with the patient diagnoses reflected in the medical records is a review that has identified something more significant than a compliance gap.
Counsel retained to oversee a compliance review that produces findings of this character is counsel who must assess not only the remediation strategy but the full scope of civil and criminal exposure that the findings represent. That assessment determines whether voluntary disclosure is appropriate, whether specific remediation measures are adequate, and whether the practitioner’s overall situation requires the kind of comprehensive legal strategy that a significant government investigation demands.
