What Is the Purpose of Having Prescription Policies
Written prescription policies serve the same function in a controlled substance prescribing practice that any written policy serves in a regulated industry: they establish the standard against which conduct is measured, provide the basis for consistent implementation, and create a record of the practice’s commitment to the regulatory obligations it operates under.
In the absence of written policies, the practice’s prescribing standard is whatever the practitioners happened to do on any given day. That standard may have been consistent, clinically appropriate, and fully compliant with applicable regulations. But it is invisible to anyone who reviews the practice’s records after the fact, including a DEA investigator who is assessing whether the prescribing reflected legitimate professional practice or commercial drug distribution. Written policies make the standard visible.
Establishing the Practice’s Clinical Standard
A written prescription policy documents the clinical expectations that govern prescribing decisions in the practice. It establishes the required components of a patient evaluation before controlled substances are prescribed, the documentation standards for controlled substance prescriptions, the PDMP consultation requirements, the patient monitoring protocols including urine drug screening and pill counts, and the criteria for discontinuing controlled substance prescribing.
When an investigator reviews the practice’s patient records against the practice’s written policies, a record that meets the policy’s requirements is a record that demonstrates compliance with an established standard. A record that fails to meet the policy’s requirements is evidence of a documentation gap, but it is a gap against the practice’s own standard rather than an amorphous failure to meet some external expectation that was never articulated. The gap is more manageable when the standard was clearly stated.
Training and Accountability
Written prescription policies enable training and accountability in a way that undocumented practice norms do not. Staff who are trained on written policies have received instruction on a specific standard. Their compliance with that standard can be audited against the policy’s requirements. Deviations from the policy can be identified and addressed through documented corrective action. The entire accountability chain that distinguishes an operating compliance program from a nominal one depends on the existence of written standards against which conduct can be measured.
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(212) 300-5196The practice whose staff received verbal instruction from the practitioner about how prescriptions should be managed has a different accountability infrastructure than the practice whose staff completed documented training on written policies and whose compliance with those policies is audited quarterly. The first infrastructure is invisible to investigators. The second is documented, and the documentation tells a story about institutional commitment that the first cannot.
Responding to Regulatory Changes
Federal and state regulations governing controlled substance prescribing change with some regularity. Clinical guidelines are updated. State PDMPs expand their requirements. State medical boards issue new prescribing standards. The practice with written policies that are reviewed and updated when applicable standards change is the practice whose policies reflect the current regulatory environment. The practice with outdated policies, or no policies, is the practice whose prescribing may be assessed against current standards that the practice never formally adopted.
Annual review of prescription policies against the current versions of applicable clinical guidelines, DEA regulations, and state medical board standards is a minimal compliance expectation. The documentation of that review, including any updates made to reflect changed standards, is evidence of an ongoing commitment to compliance rather than a static declaration of intentions.
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.
The prescription policy that was written five years ago and has never been reviewed, that does not reflect the CDC’s 2022 revised guidelines, that does not address the PDMP consultation requirements enacted in the last legislative session, and that is filed in a binder that no staff member has read, is not a compliance asset. It is evidence that the practice has a compliance program in name only. The policy that is current, that is implemented, and that is the actual standard against which clinical decisions are made is the policy that serves the purpose for which it was created.
The Policy’s Scope
Prescription policies should address the full scope of the practice’s controlled substance prescribing activities: initial patient evaluation requirements, documentation standards, PDMP consultation requirements, controlled substance agreement requirements, urine drug screening protocols, prescription monitoring procedures, prescription security and storage requirements, and the protocol for managing patients who exhibit signs of diversion or misuse. A policy that addresses some of these areas but not others leaves gaps that an investigation will identify. A policy that addresses all of them comprehensively, and that is implemented consistently, is the framework within which legitimate prescribing practice operates.