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13 Articles in Volume 18, Issue #6
Advice for the Advanced Practice Provider
Authorities’ Use of Big Data May Harm—or Help—Your Chances of Investigation
Considering Comorbidities When Selecting Medications (Part 2)
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 Opioid Use Disorder
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.
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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.

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