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What Should My Prescription Policies Emphasize?
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Your prescription policies should emphasize one thing above all else: documentation that proves you practiced medicine. Not documentation for documentation’s sake. Not paperwork to satisfy bureaucrats. Documentation that creates evidence – evidence showing your prescribing had legitimate medical purpose, evidence showing you monitored patients appropriately, evidence showing you responded to warning signs. When DEA investigators examine your practice years from now, your policies determine what evidence exists to support your defense.
Welcome to Spodek Law Group. Our goal is to explain what prescription policy elements actually matter in ways that compliance seminars don’t emphasize. Todd Spodek has defended physicians facing federal investigation for controlled substance prescribing, and the pattern is consistent: physicians whose policies emphasized the right elements had evidence to defend themselves; physicians whose policies emphasized the wrong elements – or had no policies at all – had nothing but their own testimony about what they intended.
Here’s the uncomfortable truth about prescription policies. They exist primarily to protect you from prosecution, not to protect patients from harm. Most policy elements create evidence, not better patient outcomes. That sounds cynical, but understanding this reality helps you design policies that actually accomplish their purpose. If you believe policies exist to improve patient care, you’ll design them around clinical goals. If you understand policies exist to create evidence, you’ll design them around what investigators examine.
The Five Elements That Actually Matter
Heres the system revelation that changes how you should think about prescription policy design. DEA evaluates wheather your prescribing was in the “usual course of sound professional practice.” Your documentation defines what your “usual course” was. If your policies establish certain practices and your records show you followed them, investigators see a practice that had established standards and met them. If your policies dont exist or your records show you ignored them, investigators see something else entirely.
The five elements your policies must emphasize are: PDMP verification before every prescription, urine drug testing protocols, risk-benefit documentation, patient agreement enforcement, and response protocols for concerning findings. Each of these elements creates a specific type of evidence. Each type of evidence addresses a specific prosecutorial argument. Together, they build the evidentiary foundation that proves legitimate medical practice.
Think about what that means operationaly. Every controlled substance prescription should be preceeded by a documented PDMP check. Not most prescriptions – every prescription. Every patient on chronic opioid therapy should have documented urine drug screens at appropriate intervals. Every prescribing decision should have documented risk-benefit analysis. Every patient agreement violation should have documented response. Every concerning finding should have documented follow-up.
At Spodek Law Group, we’ve seen physicians survive investigation becuase there policies emphasized these exact elements and there records showed consistant compliance. The policies didnt prevent investigation – nothing prevents investigation. But the policies created the evidence that proved legitimate medical practice, and that evidence was the difference between career survival and career destruction.
Heres something else most physicians dont consider. Every prescribing physician must complete at least 3 hours of Category 1 CME on controlled substance prescribing practices. This requirement exists becuase the goverment dosent trust physicians to stay informed voluntarily. Your policies should reference continuing education requirements and ensure you meet them. When investigators examine your qualifications, documented CME compliance creates evidence that you were maintaining current knowledge of prescribing standards.
The FDA REMS requirements for extended-release and long-acting opioid analgesics create additional obligations. Manufacturers of these medications must fund third parties to provide continuing medical education. This system exists becuase the federal government acknowledged that prescribing education was inadequate. Your policies should address any REMS requirements applicable to medications you prescribe.
Documentation Over Everything
Heres the inversion that protects physician careers. Your policies shouldnt emphasize patient outcomes. They should emphasize documentation of clinical reasoning. Good patient outcomes happen when you practice good medicine. But good outcomes dont protect you from prosecution. Documentation protects you from prosecution. Outcomes without documentation are invisible. Documentation without outcomes is still evidence.
The uncomfortable truth that nobody wants to say out loud is this: if you cant document it, it didn’t happen. Regardless of what you actually did. You might have conducted the most thorough patient evaluation in medical history. If you didn’t write it down, it dosent exist. Years from now, when investigators examine your prescribing patterns, the only evidence that exists is what appears in the medical record. Your memory isn’t evidence. Your testimony is “self-serving.” Only contemporaneous documentation counts.
Todd Spodek has seen this destroy defenses. Physicians who did everything right but documented nothing had nothing to defend themselves with. Physicians who documented thoroughly – even when there clinical practices werent perfect – had evidence showing what they were thinking and why. The documentation created the context that made there prescribing look like medicine instead of distribution.
Your policies should require documentation at every decision point. Not “document when something unusual happens.” Document everything. Why this patient needs controlled substances. What alternatives were considered and why they werent appropriate. What risks were discussed with the patient. What monitoring will occur. What findings from monitoring revealed. How you responded to those findings. Every element documented. Every time.
If its not in the medical record, investigators assume it didnt happen. Your policies must make documentation non-negotiable.
The PDMP Requirement
Heres the hidden connection that makes PDMP verification so critical. The PDMP check connects to the medical record which connects to investigation evidence which connects to your credibility. When you check the PDMP before prescribing and document that you checked, you create evidence showing you verified the patient wasnt obtaining controlled substances from multiple providers. That verification addresses one of the primary prosecutorial arguments – that you should have known the patient was doctor shopping.
CDC guidelines recommend consulting PDMPs before initiating opioid therapy and on a continuing basis. Not just at the beginning. Not just annually. Before every prescription – or at least frequently enough that you would catch developing problems. Your policies should specify how often PDMP checks occur and require documentation of every check.
The consequence cascade if you skip PDMP verification looks like this. Patient is obtaining opioids from multiple providers. You prescribe without checking PDMP. Patient overdoses. Investigation begins. Investigators find no documented PDMP checks in your records. Prosecutors argue you should have known – the information was available and you chose not to look. Your failure to check becomes evidence of negligent prescribing. The PDMP check you didn’t do costs you your career.
At Spodek Law Group, we’ve seen cases hinge on PDMP documentation. Physicians who could show documented PDMP checks before every prescription had evidence they were verifying patient legitimacy. Physicians who couldn’t show documented checks had nothing to counter the argument that they should have known there patients were obtaining drugs elsewhere.
Your policies should require PDMP verification before every controlled substance prescription. Not “when clinicaly indicated.” Every time. And the verification must be documented – either a screenshot in the chart or a notation that PDMP was checked with findings. The check without documentation is almost as bad as no check at all.
Your PDMP policy should also specify what you do when the PDMP reveals concerning findings. Patient is obtaining controlled substances from multiple providers. What happens next? Do you prescribe anyway? Do you discuss the findings with the patient? Do you terminate the relationship? Whatever you decide, document the decision and the reasoning. The PDMP check that reveals a problem and has no documented response is worse then no check at all – it shows you knew and ignored the warning.
Urine Drug Testing Protocols
Heres the paradox that makes urine drug testing policies so complicated. The more monitoring you document, the more evidence you create – but also the more opportunities for gaps that become evidence against you. If you establish a policy requiring monthly urine drug screens and you only conduct them quarterly, youve created evidence that you knew monthly was appropriate and chose not to do it.
The CDC recommends conducting urine drug testing both before initiating opioid therapy and on a continuing basis. The frequency depends on patient risk factors. Higher-risk patients should have more frequent testing. Lower-risk patients may need less frequent testing. But every patient on chronic opioid therapy needs some testing protocol – and that protocol needs to be documented and followed.
The consequence cascade when testing reveals problems is were most phsyicians get in trouble. Urine screen shows illicit substances. Physician has no documented response. Prescribing continues. Patient diverts or overdoses. Investigation reveals positive screens with no documented action. Prosecutors argue the physician knew and ignored the warning signs. Pattern of ignoring red flags becomes evidence of knowing distribution rather then legitimate medicine.
Todd Spodek has seen this exact pattern. Physicians who documented urine drug screens and documented there response to concerning findings – even when that response was continued prescribing with enhanced monitoring – had evidence of clinical judgment. Physicians who had positive screens with no documented response had evidence that they ignored warning signs.
Your policies must specify how you respond to abnormal urine drug screen results. Not just that you conduct screens, but what you do when screens reveal concerning findings. Document the results. Document your assessment of what the results mean. Document your decision about how to proceed. Document your reasoning. The response is were evidence is created – or were evidence against you accumulates.
Think about what options you have when a urine drug screen is positive for unexpected substances. You can discuss the findings with the patient and document the discussion. You can require more frequent testing and document the enhanced monitoring. You can adjust the treatment plan and document the reasoning. You can terminate the relationship and document why. Any of these responses can be appropriate depending on the circumstances. What is never appropriate is no documented response at all.
The High-Risk Combination Warning
Heres the system revelation about concurrent opioid and benzodiazepine prescribing. CDC guidelines specificaly call for “extreme caution” when prescribing these medications together due to the risk of respiratory compromise. This combination is an automatic red flag for investigators. If you prescribe both classes of medications to the same patient, your documentation needs to address why the combination is medically necessary and what precautions your taking.
Think about what “extreme caution” requires in terms of documentation. Why does this patient need both medications? What alternatives were considered? What additional monitoring are you conducting? What did you tell the patient about the risks? Did the patient understand and consent? How often are you reassesing the need for both medications? Each of these elements needs to appear in the medical record.
The practical reality is that many patients genuinly need both opioids for pain and benzodiazepines for anxiety or muscle spasm. The clinical reality dosent change the legal reality. If you prescribe this combination, you need enhanced documentation showing you recognized the risk and took appropriate precautions. Without that documentation, the combination itself becomes evidence suggesting negligent prescribing.
At Spodek Law Group, we’ve seen cases were the opioid-benzodiazepine combination was the central prosecutorial argument. Physicians who could show documented risk assessment and ongoing monitoring survived. Physicians who prescribed the combination without enhanced documentation faced serious consequences. Your policies should specifically address this combination and require enhanced documentation when its prescribed.
The respiratory compromise risk isnt theoretical. Patients die from the combination of opioids and benzodiazepines. When that death occurs in your patient population, investigators will examine your documentation to determine wheather you recognized and addressed the risk. If your policies required enhanced monitoring and your records show you followed those policies, you have evidence of appropriate clinical practice. If your policies didnt address the combination or your records dont show enhanced monitoring, you have a serious problem.
Todd Spodek has defended physicians in cases where patient deaths involved opioid-benzodiazepine combinations. The physicians who survived had documented risk assessments, documented patient education, and documented ongoing monitoring. The documentation didnt prevent the deaths – nothing could of prevented some of those deaths. But the documentation proved the physicians recognized the risk and took appropriate precautions.
Operational Details That Save Careers
Heres the irony that most physicians dont realize. The recommendation to write 28-day prescriptions instead of 30-day isnt about patient care. Its about ensuring refill requests always fall on business days when your office is staffed. A 30-day prescription written on a Tuesday means refills fall on different days each month. A 28-day prescription written on a Tuesday means refills always fall on Tuesday. You control when patients need to contact you.
This operational detail matters becuase of what happens when covering physicians handle refill requests. Your policies should limit what covering physicians can do. Standard one-month refill if the patient is due – nothing more. No early refills from covering providers. No dose changes. No new controlled substance prescriptions. These limitations exist becuase covering physicians dont know your patients and shouldnt be making prescribing decisions.
The consequence cascade when covering physicians dont follow these limitations is devastating. Covering physician gives early refill to avoid conflict with patient. Patient diverts the extra medication. Investigation reveals your practice allowed early refills despite policy saying otherwise. Gap between policy and practice becomes evidence that your practice didnt enforce its own standards. The covering physicians decison becomes your problem.
Your policies should specify exactly what covering physicians can and cannot do regarding controlled substances. And your practice must actualy follow those policies. Train your covering physicians. Document there agreement to follow your protocols. Monitor there prescribing when there covering for you. The operational details that seem minor become major when investigation examines every prescription your practice issued.
No refills of controlled medicines should be provded after hours. This isnt just practical advice – its evidence that your practice maintained appropriate controls. Investigators look at when prescriptions were issued. Controlled substance refills at 2am suggest a practice that wasnt maintaining appropriate oversight. Your policies should prohibit after-hours controlled substance prescribing and your records should show compliance.
Building Policies That Create Evidence
Heres the bottom line for what your prescription policies should emphasize. Policies dont prevent bad outcomes. Policies create evidence showing you took reasonable precautions despite bad outcomes. Every element of your policy should be designed to create a specific type of evidence that addresses a specific prosecutorial argument.
Start with PDMP verification. Every prescription. Documented every time. This creates evidence you werent prescribing to patients obtaining drugs from multiple providers.
Add urine drug testing protocols. Frequency based on risk. Results documented. Response to concerning findings documented. This creates evidence you were monitoring for compliance and responding to warning signs.
Include risk-benefit documentation requirements. Every prescribing decision should have documented reasoning. Why this medication. Why this dose. Why continued therapy. This creates evidence of clinical judgment.
Specify patient agreement enforcement. What happens when patients violate agreements. How violations are documented. When termination occurs. This creates evidence you established expectations and enforced them.
Address high-risk combinations. Enhanced documentation for opioid-benzodiazepine. Risk assessment. Patient education. Ongoing monitoring. This creates evidence you recognized elevated risk and took appropriate precautions.
Call Spodek Law Group at 212-300-5196. We can help you evaluate wheather your current prescription policies emphasize the elements that actualy matter. The consultation is free. The cost of having policies that dont create the evidence you need is not.
Your prescription policies exist to create evidence that your prescribing had legitimate medical purpose. Every element should serve that goal. PDMP checks prove you verified patient legitimacy. Urine drug screens prove you monitored for compliance. Risk-benefit documentation proves you exercised clinical judgment. Patient agreement enforcement proves you established and maintained standards. Together, these elements create the evidentiary foundation that proves you practiced medicine – not just prescribed controlled substances.
The physicians who survive federal investigation are the ones whose policies emphasized the right elements and whose records showed consistant compliance. The physicians who face prosecution are the ones whose policies emphasized the wrong things – or who had no policies at all. Design your policies around what investigators examine. Follow them consistantly. Document everything. Your future self will need that evidence.
Remember that investigations often begin years after the prescriptions were written. The policies you establish today create the documentation that will be examined in 2028 or 2030. The prescribing decisions you make this week will be judged against standards that may evolve between now and then. Your documentation needs to stand on its own, explaining and justifying your decisions to investigators who werent there when you made them.
The policies that survive federal scrutiny share common characteristics. They emphasize documentation at every decision point. They require verification before prescribing. They specify monitoring protocols and response procedures. They address high-risk situations with enhanced requirements. And most importantly, they reflect what the practice actualy does – not aspirational standards that sound impressive but arent followed. Build policies you will follow. Follow them every time. Document everything. Thats how you create the evidence that proves legitimate medical practice.