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13 Articles in Volume 18, Issue #6
Authorities’ Use of Big Data May Harm—or Help—Your Chances of Investigation
Gaps in the Pharmacist’s Pain Management Role
How can cyproheptadine manage complicated chronic pain cases?
Letters to the Editor: Trackable Pills; Buprenorphine; CRPS Diagnosis
Managing a New High-Dose Opioid Patient
Managing Opioid Use Disorder
Medication Selection for Comorbid Pain Management (Part 2)
Mobile Trackers and Digital Therapeutics
New Insights in Understanding Chronic, Central Pain
Nocebo Effects: How to Prevent them in Patients
Polarizing Topics in Chronic Pain
The Fight to End Peripheral Neuropathy
Urine Drug Monitoring

Authorities’ Use of Big Data May Harm—or Help—Your Chances of Investigation

A former prosecutor and current defense lawyer shares strategies to help protect your practice.

This is an extended online version from that which appeared in the September 2018 journal.

As pain practitioners well know, two recent developments – one federal, one state – have combined to increase the risk of providers being investigated for prescribing opioids for their patients. The federal government has formed special task forces to focus on this matter while state governments are increasingly requiring controlled substance prescription reporting by physicians and authorized DEA registrants. Many of the prosecutions arising from these investigations will have merit; some will not. With so much emphasis now placed on diversion, misuse, and abuse, some very well-meaning doctors, who may be less than careful with their documentation or prescribing habits, are bound to be swept up in this ongoing battle against opioids. To avoid becoming a subject of an investigation, now is the time to understand the increased risk and protect your practice.

Investigations on the Rise: Why and Where

At the federal level, US Attorney General Jeff Sessions announced in August 2017 the formation of 12 Opioid Fraud and Abuse Detection Units to coordinate enforcement among national, state, and local agencies. The special units rely on FBI, DEA, and HHS investigators, as well as state medical boards, attorney general staff, and even local police, to investigate practitioners.  Intended as a pilot program, Sessions directed, according to his August 2017, statement, the task forces to use data analytics programs to identify and prosecute individuals who may be writing opioid prescriptions at a rate that far exceeds their peers.  The Department of Justice funded a full-time prosecutor to head up the units in 12 key states, including Alabama, California Florida, Kentucky, Maryland, Michigan, Nevada, North Carolina, Pennsylvania, Tennessee, and West Virginia, all hit hard by the opioid crisis.  

Compared to state prosecutors, federal prosecutors historically reject more cases than they accept for filing, adhere to a higher standard of proof, and generally have the opportunity and resources to investigate their cases before filing charges. However, local US Attorneys’ Offices are under immense pressure to bring opioid indictments, so in instances where federal prosecutors reject charges, state or local prosecutors may file them in state courts. In addition, if the newly funded task forces do, in fact, focus their resources on analysis of data, they will likely have easier access to the information, including the ability to review a larger amount of it in real time. Take a look:

  • 49 states have active Prescription Drug Monitoring Programs (PDMPs) (Missouri is the exception).
  • 23 states make Patient, Prescriber, and Dispenser reports available to law enforcement in active investigations.
  • 40 states require prescribers and dispensers to query the PDMP when prescribing controlled substances.

The goal of these programs is to reduce misuse and diversion of controlled substances, thereby improving patient and public safety. However, the result of this growing collaboration and compilation of big data is that prosecutors now have a very detailed list of heavy opioid prescribers, from primary care providers to pain specialists.

Possible Charges Against Pain Practitioners

In prescribing cases, federal prosecutors may bring charges under the criminal statute for unlawful distribution of controlled substances, often accompanied by charges of healthcare fraud. Conviction may result in federal prison, stiff fines and mandatory restitution, followed by a term of supervised release. State charges most often come under diversion-type prohibitions, such as the one in Pennsylvania’s Controlled Substances, Drugs, Device, and Cosmetic Act. This law makes it a felony for any physician or person working under his or her direction to “administer, dispense, deliver, give, or prescribe any controlled substance unless done (i) in good faith in the course of his [sic] professional practice; (ii) within the scope of the patient relationship; (iii) in accordance with treatment principals accepted by a responsible segment of the medical profession.” Sentences under this section involve prison, fines, and probation following release from custody.

Conviction under either federal or state law almost always results in automatic loss of the practitioner’s medical license. State licensing boards may suspend a license summarily upon arrest by either state or federal officers (ie, “shoot first and ask questions later”). Those who manage to keep their licenses often face the loss of DEA-controlled substance prescribing authorization, suspension or revocation of hospital privileges, required reporting to the National Practitioner Data Bank, exclusion from participation in Medicare and Medicaid, loss of credentialing by patient insurers, and inability to obtain or retain malpractice coverage. Felony drug or healthcare fraud convictions may also result in mandatory exclusion from federal healthcare programs for five years.

The legal requirements for these state charges make it easy for prosecutors to file, and can be hard to defend against. For example, in Pennsylvania, a practitioner: must show that he or she subjectively (ie, sincerely) believed that a prescribed treatment was “good medicine” for a given patient’s condition; must ensure that a prescribed treatment was within an “established” doctor-patient relationship provable by tangible, physical evidence; and, that the prescribed treatment was within the accepted standard-of-care by “a responsible segment of the medical profession” (ie, the government prosecutor’s designated testifying expert); otherwise, he or she can be convicted under the state’s drug laws of a criminal offense.

Under federal law, the legal test is more nuanced. A practitioner licensed to prescribe controlled substances may be nonetheless convicted of illegal drug distribution (ie, “trafficking”) if prosecutors can prove the doctor prescribed scheduled substances outside of the usual course of professional practice, and that such prescription was not for a legitimate medical purpose. While this does not make it a crime to prescribe in a negligent or even reckless manner, it does lower the government’s burden for conviction below a knowing and intentional violation of the federal crimes code. Once a practitioner understands these increased risks, there is no excuse not to manage his or her practice better, as described below.

Precautionary Steps to Take Now

First and foremost, consider the data analytics about your prescribing practices as part of your risk management strategy. Federal and state agents have access to this information, so clinicians should have a clear understanding of what that data shows. Below are some basic checks to perform on your practice, as well as controls to put in place from a drug-diversion perspective. Keep in mind that any high-volume practice, or practice with a high population of cash-paying patients, will automatically move to the top of a prosecutor’s review list.

Document, Document, Document

Ensure that records for any patient prescribed a controlled substance can answer the following:

  • How did the patient find your practice (eg, a scheduled appointment or referral, based on the patient’s insurance options, a neighbor asking for a script)? A pre-consultation questionnaire may be utilized to obtain this information.
  • How did the patient arrive at your office (eg, Did he drive from an unreasonable distance, instead of going to a closer doctor’s office? Did he arrive with a number of other patients from the same place, who claim not to know each other, yet they all have the same complaint and seek the same medications)? Office reception staff should be sensitized and enlisted in the physician’s overall compliance effort, such as by observing if groups of patients arrive together.
  • What were the patient’s presented medical concerns and how did you address them? Can you state that you would prescribe the same treatment plan, for example, to your own mother? This question has been asked in court. 
  • If applicable, is an Opioid Therapy Patient Agreement, or similar agreement, in place and on file?
  • What type of follow-up has/is been conducted? Are side effects being managed? What type of drug monitoring controls are being used (eg, PDMP, urine drug testing)?
  • Is each and every patient visit documented? Was a physical exam conducted at each visit or regularly to ensure the continued care plan is legitimate and recognized within the standard of care?

Maintain Strong Provider-Patient Relationships

Next, a practitioner should consider how an investigator might perceive the nature of the provider-patient relationship:

  • How much time did you spend with the patient? 
  • As part of the initial examination, did you ask for a personal and family history of substance abuse and mental health? 
  • Did you examine the patient on each occasion they presented at your office for a script or a refill?  If not, why not? 
  • In addition to filing a Patient Agreement for controlled substance use, have you counseled the patient on the risks of taking opioids, including the risks of addiction, dependence, drug-drug interactions, and the importance of taking their medications strictly as prescribed? 
  • Who wrote out the prescriptions—you or a staff member, such as a nurse practitioner without a DEA registration—and who actually signed it?  Did the patient actually see you for a refill, or just a member of the staff?
  • Have you complied with DEA regulations for prescribing? For instance, 28 C.F.R. §1306.05(a) requires that “all prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.”

Align Treatment Principles with Best Practice

When prescribing chronic opioid therapy or other controlled medications, it is crucial to ensure that the approach utilized is the safest one indicated for the general condition and for the specific individual patient. It is also important to have an understanding of the culture in your practice. For instance:

  • For what length of time are you writing the prescription, and why? When in doubt, write a script for one week instead of one month, and, if appropriate, write for a dosage or a timeframe less than is otherwise the largest dose a patient should safely have for the longest period of time. 
  • Are there patient requests for specific medications or doses? High doses, short-acting opioids, and other specific requests—such as for tablets—can raise a red flag.
  • Are there requests for high doses of short-acting opioids or Oxycodone?  Drug prosecutors and diversion investigators often state that Oxycodone 30 mg. tablets are the number one abused and diverted prescription.

Keep Calm and Carry On

The questions and examples contained herein may turn off a physician from practicing or continuing to practice pain medicine. However, these scenarios often represent the worse case; most clinicians already abide by these protocols and standards.  Moreover, they have a responsibility to help those patients who truly require high doses of controlled medications to effectively manage their chronic pain; these patients, in most case, are not misusing or diverting their prescriptions. Many patients turn to pain specialists because their insurance carriers or primary care doctors have suggested they are overmedicated, and they need you, not another referral. In small practice settings, clinicians may wish they had a partner to consult when making difficult prescribing decisions—or back them up when needed.

Regardless of your situation, by documenting your actions extensively, your reasons for them, the alternative treatment options explored, and the conversations you had with your patient—you can help protect yourself from any potential investigation, and help defend yourself if caught up in one.  If a prosecutor claims that the quantity and frequency of a controlled substance prescription exceeds what a “responsible” practitioner would issue, you will be able to rely on your strong record supporting your actions and directions to the patient.

Overprescribing, diversion, and drug abuse have created a chronic opioid crisis in America and brought untold heartache and loss throughout.  In response, federal and state law enforcement and their reliance on newly available prescribing data have stepped up investigations and prosecutions.  Pain practitioners and controlled substance practitioners must similarly step up their own protective measures to keep from becoming collateral damage in the government’s expanding war on drugs, in ways that contribute to patient care and not undercut, with increased attention to compliance, documentation and careful drug prescription monitoring. 

As enforcement efforts drive more and more primary care practitioners away from prescribing controlled substances for pain management, the role of the specialist becomes more and more essential for the adequate care of patients who in good faith require legitimate medical care for pain treatment.  Federal support and funding for new interagency task forces will continue to step up these enforcement efforts.  In combination now with states’ mandating the regular and prompt reporting of controlled substance prescriptions through PDMP registers, these task forces have become adept at identifying high-volume prescribers, often practitioners in pain treatment.  It may not be enough to just practice good specialty medicine anymore; doctors need to protect themselves and their practices and be able to demonstrate that they are practicing lawfully.  Take steps now so you are not only practicing good specialty medicine, but so that you can demonstrate this if government agents come knocking.

Last updated on: September 12, 2018
Continue Reading:
How to Avert Government Scrutiny When Prescribing Opioids
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