Criminal Defense Lawyers

What Is the Purpose of Having Prescription Policies?

What Is the Purpose of Having Prescription Policies?

The purpose of prescription policies isn’t to control your patients. It’s to create evidence that you were practicing medicine – not distributing drugs. When DEA investigators review your practice, they’re not looking for policies. They’re looking for proof that your prescribing had legitimate medical purpose. Your policies create that proof. Without them, you have nothing but your testimony about why you made the decisions you made. With them, you have contemporaneous documentation showing you followed established medical practice.

Welcome to Spodek Law Group. Our goal is to explain what prescription policies actually accomplish in ways that compliance seminars don’t emphasize. Todd Spodek has defended physicians facing DEA investigation, and the pattern is consistent: doctors who had comprehensive policies and followed them had evidence to support their prescribing decisions; doctors who prescribed without policies – or who had policies they didn’t follow – had almost nothing to defend themselves with.

Here’s the paradox that destroys physician careers. Having prescription policies you don’t follow is worse than having no policies at all. The policies become the standard you’re judged against. If you create detailed protocols and then deviate from them, investigators don’t see a busy doctor making practical adjustments. They see a physician who knew what proper practice looked like and deliberately chose not to do it. Your own policies become prosecution evidence.

What Prescription Policies Actually Do

Heres the inversion that changes how you should think about prescription policies. The policies arnt really agreements between you and your patients. There agreements between you and future investigators. Every policy you establish creates a standard. Every time you follow that standard, you create documentation. That documentation becomes the evidence that proves – or disproves – whether your prescribing constituted legitimate medical practice.

Think about what DEA investigators actualy look for during an investigation. They examine the proportion of controlled substances you prescribe compared to other medications. They check wheather you use pain management contracts with patients. They verify wheather your practice enforces its own policies. Each of these factors contributes to there assessment of wheather your prescribing had legitimate medical purpose.

At Spodek Law Group, we’ve seen investigations hinge on this exact issue. Physicians who could demonstrate they followed established protocols – who had documentation showing policy compliance – had evidence supporting legitimate practice. Physicians who couldnt demonstrate policy compliance had prosecutors arguing there prescribing was indistinguishable from drug distribution.

The system revelation most physicians miss is that DEA may beleive prescriptions are medically unnecessary if a practice dosent use or enforce pain management contracts. Not having policies isnt neutral. Its evidence that suggests you werent practicing medicine the way legitimate physicians practice medicine. The absence of policies becomes part of the prosecutions case.

DEA investigators have described there approach as looking at the “totality of circumstances.” They examine your patient population, your prescribing patterns, your documentation practices, and your policies – all together. A practice with comprehensive policies that are consistantly followed looks like legitimate medicine. A practice without policies – or with policies that exist only on paper – looks like something else entirely. The policies you have or dont have shape the narrative investigators construct about your practice.

The Documentation Defense

Heres the uncomfortable truth that defense attorneys understand but compliance consultants dont emphasize. A physician cannot testify credibly to information that wasnt documented in the chart at the time of treatment. If you didnt write it down when you treated the patient, you cant convincingly explain it years later when investigators are examining your prescribing patterns.

The documentation motto that every physician needs to internalize is this: “If it was important at the time the patient was treated, it is in the medical record.” Investigators apply this standard ruthlessly. If your medical reasoning wasnt documented contemporaneously, investigators assume it didnt exist. Your after-the-fact explanations sound like excuses, not medical judgment.

Todd Spodek has seen this pattern destroy defenses. Physicians who had thorough documentation could point to specific entries showing why they prescribed what they prescribed. Physicians who relied on memory – who said “I remember thinking at the time” – had nothing except there own testimony. And prosecutors argue that testimony is self-serving fabrication designed to avoid conviction.

The hidden connection most physicians completly miss is how prescription policies link to medical records link to investigation evidence link to your credibility at trial. Your policies establish what you should document. Your documentation creates the record. The record becomes evidence. The evidence determines wheather jurors beleive you were practicing medicine or distributing drugs.

Every prescribing decision should have documented justification. Not becuase paperwork is important, but becuase that documentation is the only evidence that will exist years from now when someone questions why you prescribed what you prescribed.

The practical implication is that your prescription policies must require documentation as part of every prescribing decision. The policy dosent just say “consider alternatives.” It says “document consideration of alternatives.” The policy dosent just say “assess patient risk.” It says “document risk assessment findings.” Every step in the policy creates a documentation requirement, and every documentation requirement creates evidence of legitimate medical practice.

Why Having Policies Isn’t Enough

OK so heres the paradox that makes prescription policies so dangerous if mishandled. The policies you create become the standard you get judged against. If you establish a policy requiring PDMP checks before every controlled substance prescription, and investigators find prescriptions without corresponding PDMP checks, you havent just failed to follow best practices. Youve demonstrated that you knew what proper practice required and chose not to do it.

The consequence cascade looks like this. You create comprehensive policies becuase you want to protect your practice. Those policies establish specific requirements. You get busy. You skip a step here and there. Investigation begins. Investigators compare your stated policies to your actual practice. They find gaps. Those gaps become evidence of knowing deviation from established standards. The policies you created to protect yourself become the evidence that convicts you.

At Spodek Law Group, we’ve seen this exact pattern repeatedly. Physicians who created detailed protocols and then followed them inconsistantly faced worse outcomes then physicians who had simpler policies they actualy followed. The gap between policy and practice is were prosecutors find evidence of criminal intent.

Heres the irony that makes this even more complicated. The more detailed your policies, the more potential deviation points investigators can examine. A ten-page policy manual creates ten pages of standards you might have failed to meet. A simple policy creates fewer opportunities for documented failure. But simpler policies also provide less protection if you did follow them. Theres no perfect answer – only tradeoffs that need to be understood.

The practical reality is that your policies must be policies you will actualy follow. Every requirement you include is a requirement you must meet. Every standard you establish is a standard you will be judged against. Dont create policies that sound impressive but that you cant realistically implement. Create policies that reflect what you will actualy do, then do it consistantly.

What Your Policies Should Include

Heres the system revelation that helps you understand what policies to create. DEA investigators look for specific red flags. Your policies should address each of those red flags with documented protocols.

The red flags investigators examine include: high proportion of controlled substances relative to other medications, cash-only payment for opioid prescriptions, patients traveling long distances to see you, inventory irregularities, and wheather you use and enforce patient agreements. Each of these factors can be addressed through policy – and each policy creates documentation that counters the red flag.

Think about what that means for policy design. If investigators look for high controlled substance ratios, your policies should include protocols for considering non-opioid alternatives and documenting why controlled substances were necessary. If investigators look for cash payments, your policies should address payment documentation. If investigators examine wheather you enforce patient agreements, your policies must include termination protocols and documentation requirements when patients violate agreements.

At least 33 states have statutory limits on opioid prescriptions as of 2020. Your policies need to address state-specific requirements along with federal standards. The interaction between state and federal requirements creates complexity – but also creates opportunity to demonstrate you were aware of and complying with applicable regulations.

Todd Spodek has seen physicians survive investigation becuase there policies addressed the specific factors DEA examines. The policies didnt prevent investigation – nothing prevents investigation. But the policies created documentation that proved legitimate medical purpose, and that documentation was the difference between career survival and career destruction.

Heres something else most physicians dont realize. DEA investigations often review records going back six years or more. Your policies today create documentation that may be examined years from now, in circumstances you cant predict. The prescriptions you write this week might become the subject of investigation in 2030. Your documentation needs to stand on its own, explaining and justifying your decisions to investigators who werent there when you made them.

The Patient Agreement Paradox

Heres the paradox that most physicians dont fully understand about controlled substance agreements. A 2014 survey found that most primary care physicians beleive these agreements dont actualy reduce patient misuse – but they do give physicians a “sense of protection against liability.” The agreements exist primarily to protect you, not to protect patients.

Think about what that means. The document you present to patients as being about there health and safety is actualy about creating evidence for your defense if investigation ever comes. The agreement dosent meaningfully change patient behavior. It creates documentation that you established expectations, communicated risks, and obtained acknowledgment.

The irony is that patients sign these agreements becuase they need medication. There not negotiating from equal positions. A patient with genuine chronic pain will agree to almost anything to obtain needed treatment. The “agreement” isnt really a negotiation – its documentation that certain disclosures were made and certain expectations were established.

At Spodek Law Group, we’ve seen patient agreements make the difference in investigations. Not becuase the agreements prevented diversion – they often didnt. But becuase the agreements documented that physicians had taken reasonable precautions. When a patient who signed an agreement later diverted medications, the physician could demonstrate they had established and communicated appropriate policies. The diversion happened despite reasonable precautions, not becuase of negligent prescribing.

Every patient recieving controlled substances should sign a written agreement. Not becuase the agreement will prevent misuse, but becuase the agreement creates evidence that you were practicing medicine responsibly. That evidence matters enormously if your prescribing is ever questioned.

The controlled substance agreement should include several key elements. It should inform patients about risks of tolerance and dependence. It should require that only one doctor prescribe and one pharmacy dispense. It should state that lost or stolen prescriptions wont be replaced. It should prohibit dose increases without physician approval. And it should require compliance with monitoring like urine drug screens and pill counts. Each of these elements creates documentation that you established appropriate expectations and obtained patient acknowledgment.

When a patient signs this agreement and later violates it, you have documented evidence showing what expectations were established. When you terminate that patient for violations, you have documentation showing you enforced your policies. The termination itself becomes evidence that you were monitoring for diversion and taking appropriate action when problems arose. Thats the real purpose of these agreements – creating an evidentiary trail that proves you were practicing medicine responsibly.

When Policies Become Evidence Against You

Heres the uncomfortable truth that nobody explains untill its to late. Your policies dont just protect you – they establish the standard against which your conduct will be measured. If you create a policy requiring monthly urine drug screens and you only conduct them quarterly, you havent demonstrated that you were doing more then the minimum. Youve demonstrated that you knew monthly screens were appropriate and chose not to do them.

Random chart reviews during investigation compare your stated policies to your actual practice. Investigators arnt looking for perfection. There looking for patterns. If your policies say one thing and your records show another thing, that gap becomes evidence of knowing deviation. You knew what you should do. You chose not to do it. That choice suggests your prescribing wasnt about legitimate medicine – it was about something else.

The consequence cascade is brutal. Policy establishes standard. Practice deviates from standard. Investigation reveals deviation. Prosecutors argue deviation proves you knew proper practice and deliberately avoided it. Jury concludes you werent practicing medicine. Conviction follows. The policies you created to protect yourself provided the framework for your prosecution.

Todd Spodek has seen this happen. Physicians who thought there detailed policies demonstrated commitment to compliance discovered those same policies created the evidentiary basis for criminal charges. The lesson isnt to avoid policies. The lesson is that policies you create must be policies you follow – every time, without exception, with documentation.

Think about what that requires operationaly. Before you create any policy, ask yourself: Will I actualy do this? Can my staff actualy implement this? Do I have systems to document compliance? If the answer to any of these questions is no, dont create that policy. A policy you cant follow is worse then no policy at all.

The DEA Administrative Law Judge system has evolved significanly in recent years. One judge noted that federal efforts to address prescription medication dependence have led to “an increasingly complex and nuanced practice of administrative law before the Drug Enforcement Administration.” Physicians stand to lose enormously from investigation – there DEA registration, there medical license, there career, potentially there freedom. Given those stakes, thorough policy compliance isnt just good practice. Its survival.

Building Policies That Actually Protect You

Heres the bottom line for creating prescription policies that actualy protect your practice. The policies must reflect what you will actualy do, and you must document everything. The documentation is the defense. Without it, you have nothing.

Start with the recognition that your policies are evidence. Every requirement you establish creates a standard. Every time you meet that standard and document it, you create evidence of legitimate medical practice. Every time you fail to meet the standard, you create evidence that undermines your defense.

The policies that survive investigation have certain characteristics. They address the specific factors DEA examines. They establish clear, followable protocols. They require documentation at every step. They include procedures for handling patient violations. They reflect actual practice, not aspirational standards.

Consider conducting regular internal audits of your own compliance. Random chart reviews comparing your stated policies to actual practice can identify gaps before investigators find them. This isnt paranoia – its prudent practice management. The gaps you identify and correct yourself are gaps that wont appear in investigation findings. The documentation showing you conducted audits and made corrections demonstrates commitment to compliance.

Your staff needs training on your policies. They need to understand not just what the policies require, but why those requirements matter. When every staff member understands that documentation creates evidence and evidence determines outcomes, documentation becomes more thorough. This isnt about creating paperwork burden. Its about creating the evidence that proves your practice is legitimate medicine.

Call Spodek Law Group at 212-300-5196. We can help you evaluate wheather your current prescription policies create the protection you think they create. The consultation is free. The cost of having policies that become evidence against you is not.

Your prescription policies exist for one reason: to create evidence that your prescribing had legitimate medical purpose. That evidence must be contemporaneous – created at the time of treatment. It must be thorough – addressing every prescribing decision. It must be consistent – showing you followed your own standards. And it must survive the scrutiny of investigators who will examine your records years after the prescriptions were written.

The physicians who survive DEA investigation are the ones who built policies they could follow, followed them consistantly, and documented everything. The physicians who face prosecution are the ones whose policies existed on paper but not in practice – or who had no policies at all. Build your policies now. Follow them every time. Document everything. Your future self will need that evidence when investigators start asking questions about prescriptions you wrote years ago and can barely remember.

Remember what determines credibility during investigation: if it was important at the time, it should be in the medical record. If its not in the record, investigators assume it wasnt important – or didnt happen. Your policies create the framework for what goes in the record. Your documentation fills that framework with evidence. Together, they create the defense that proves you were practicing medicine, not distributing drugs. Build that defense now.