Prescription policies in a controlled substance prescribing practice should emphasize the clinical judgment, documentation, and monitoring activities that distinguish legitimate medical prescribing from commercial drug distribution. The emphasis should fall where the legal and clinical standards converge: on the documentation of medical necessity, the exercise of professional oversight, and the response to indicators of diversion or misuse.
A prescription policy that emphasizes the paperwork requirements of controlled substance prescribing without emphasizing the clinical judgment that the paperwork is supposed to reflect has gotten the relationship backward. The policy’s purpose is to ensure that clinical judgment is exercised, documented, and consistently applied. The documentation requirements exist to capture that judgment, not to substitute for it.
The Initial Patient Evaluation
Prescription policies should specify the components of the patient evaluation required before any controlled substance is prescribed. At minimum, the evaluation should include a history of the presenting complaint and its duration and functional impact, a review of prior treatments and their outcomes, a physical examination with findings relevant to the complaint, a current medication list including all controlled substances, a PDMP review documenting the patient’s current controlled substance prescription history, and a risk assessment for opioid use disorder or diversion using a validated clinical tool.
The initial evaluation standard is the most important component of the prescription policy because it establishes the clinical baseline from which all subsequent prescribing decisions are made. A patient for whom a thorough initial evaluation was documented is a patient whose prescribing has a clinical foundation. A patient whose initial record contains only a diagnosis code and a prescription is a patient whose prescribing has no documented clinical foundation, and no subsequent documentation can supply what the initial evaluation should have recorded.
PDMP Consultation Requirements
The prescription policy should specify that PDMP consultation is required before any controlled substance prescription is issued and that the results of the consultation are documented in the patient’s encounter record. The policy should specify what information from the PDMP is clinically significant and how prescribing decisions should be informed by that information: for example, that a patient receiving controlled substances from multiple prescribers should be addressed through a conversation with the patient documented in the record before any additional prescription is issued.
The PDMP consultation requirement should apply not only to new prescriptions but to refills. The patient’s controlled substance prescription history can change between visits in ways that affect the clinical appropriateness of continued prescribing, and a PDMP check at each prescribing encounter is the minimum standard for awareness of those changes.
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(212) 300-5196Patient Monitoring Requirements
The prescription policy should establish the monitoring activities required for patients who are maintained on chronic opioid therapy. Urine drug screening at intervals appropriate to the patient’s risk level, with documentation of the results and the clinical response to unexpected findings, is the monitoring standard most frequently referenced in clinical guidelines. Pill counts, in-office medication reviews, and behavioral monitoring using validated tools are additional monitoring activities that the policy can specify for higher-risk patients.
The policy’s monitoring requirements should be calibrated to patient risk: more frequent monitoring for patients at higher risk of misuse or diversion, less frequent monitoring for patients with long-term stable compliance. This risk stratification reflects the individualized clinical approach that legitimate pain management requires and that distinguishes it from the one-size-fits-all prescribing that characterizes commercial drug distribution.
Discontinuation Criteria
The prescription policy should specify the clinical criteria that will result in the discontinuation or taper of controlled substance prescribing. Urine drug screens that show the absence of prescribed medications, indicating diversion; the presence of illicit substances, indicating concurrent non-medical drug use; evidence of prescription sharing, pill selling, or other diversion; failure to comply with the controlled substance agreement; and obtaining controlled substances from other prescribers without disclosure are each criteria that the policy should address.
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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.
Federal agents execute a search warrant at your medical practice, seizing patient records and prescription logs.
Can they take patient records without patient consent?
A valid federal search warrant overrides HIPAA privacy protections. However, the warrant must be properly scoped. An attorney can challenge overly broad warrants and move to suppress improperly seized evidence.
This is general information only. Contact us for advice specific to your situation.
The prescription policy that specifies discontinuation criteria and that is implemented consistently, meaning that the practice actually discontinued prescribing for patients who met those criteria and documented the clinical basis for the discontinuation, has demonstrated an institutional commitment to diversion prevention that is difficult to characterize as commercial drug distribution. The fact that some patients were discontinued for non-compliance is evidence that the practice applied clinical judgment to its prescribing decisions rather than simply fulfilling requests.
Documentation of Exceptions
Clinical practice produces exceptions: patients who require higher doses than the policy’s standard dosage guidelines, patients who cannot comply with urine drug screening due to legitimate medical conditions, patients whose situation justifies continued prescribing despite a positive urine drug screen for illicit substances because the clinical risk of abrupt discontinuation exceeds the risk of continued prescribing. The prescription policy should address how exceptions are documented and what additional clinical oversight is required when a prescription decision departs from the policy’s standard requirements. Exceptions documented with clinical specificity are clinical decisions. Exceptions that occur without documentation are departures from the standard without explanation, and that characterization serves the prosecution rather than the defense.
