Your Medical Practice and DEA Investigations

A federal criminal target letter from a local United States Attorney notifies a potential defendant that they are the “target of” an FBI, DEA, or other governmental agency criminal investigation. Target letters say “you are the target” and place the recipient on notice to hire an attorney.

Recently, a medical practitioner brought me a new letter.  This letter notified him that his practice was now under federal criminal investigation. It was not a target letter, per se, but a letter asking him to meet.  I was amazed.

The letter stemmed from a 2017 DHS administrative subpoena for medical records for a small subset of that physician’s patient files. The DEA subpoenaed specific patient files based upon patient’s DEA records indicating they had received a substantial number of controlled substance prescriptions. The DEA learned this information through a computer search of this physician’s prescribing patterns, pharmacy dispensing patterns, and actual patient received controlled substance prescriptions.  The DEA then subpoenaed the medical records to see if the doctor had a medical basis to write the prescriptions the database revealed.  Doctors have become the targets of the opioid crisis.

After the physician produced his records the DEA submitted the medical records to their expert physician. This is when something unusual happened.  The US Attorney took the time to notify the physician the expert concluded the physician’s prescribing pattern, quantity, and frequency of controlled substance prescriptions served no legitimate medical purpose in the usual course of professional practice. His medical practice for that small set of patients was criminal in nature.

The US Attorney did not simply indict the doctor.  The government identified to the doctor the numerous deficiencies and violations of standards in the physician’s prescribing practice:

1. The physician was prescribing high-dose opioids frequently with benzodiazepines;
2. The medical records did not identify a medical condition justifying the prescribing;
3. The physician failed to document changes in prescribing patterns between patients with changing medical conditions;
4. The physician failed to document increase in benefit to the patient from the opioid treatment and failed to provide alternate treatments;
5. The physician failed to stop prescribing Opioids after proof of failed drug screens:
6. The physician failed to stop prescribing opioids when no drug screens were performed;
7. The physician failed to stop prescribing opioids to patients with positive drug test for alcohol, other opiates and benzodiazepines;
8. The physician prescribed controlled substances without performing any physical examination;
9. The physician prescribed controlled substances without a patient treatment plan, or inadequate treatment plans;
10. The physician prescribed controlled substances to patients with no confirmed diagnosis of a medical condition;
11. Patient records were inadequate, missing, or unreadable or did not have current medication or diagnosis notated in the file;
12. Many files did not possess updated Pennsylvania prescription drug monitoring program reports

Amazingly this United States Attorney told the physician his medical records reflected in extraordinary pattern of distributing controlled substances while failing to satisfy relevant standards under the Controlled Substances Act and the False Claims Act. The physician was put on notice that the Controlled Substances Act and it’s implementing regulations require prescriptions be issued for legitimate medical purposes by any individual practitioner acting in the usual course of his profession. 21 CFR 1306.04(A).

If a prescription is issued but fails to satisfy those standards to prescription, it is not valid under 21 USC § 842(a)(1), 21 USC § 829(a). These violations provide for a civil penalty under 21 USC § 842C1A of not more than $25,000 per prescription or no more than a total of $64,820 for all violations after November 2, 2015. The physician was also notified that if Medicare paid for any of the prescriptions under a federal healthcare program, the physician was subject to False Claims Act triple damages under 31 USC § 3729.

This doctor was invited him to come and talk to the United States attorney and the Department of Justice about this letter and the 12 files in question.  Most importantly:

1. the doctor was not yet indicted;
2. his entire office files were not seized;
3. his personal and business assets were not subject to civil forfeiture claims
4. his personal and business assets were not frozen
5. he was not forced to surrender his DEA prescribing Authority as a bail condition over a holiday weekend;
6. he was not emergently charged by the Pennsylvania Medical Board;
7. and he not in jail.

My other clients have not been as fortunate to receive, while intimidating, such an explicit letter.  This doctor was invited to talk to the United States Attorney and the Department of Justice about this letter.  If you have received a letter similar to this please call me to discuss your options.

Pennsylvania’s New Opioid Treatment Agreement Law

On Nov. 27, 2019 Pennsylvania Governor Tom Wolf sign into law Act 112 of 2019.  This is Pennsylvania’s Opioid Treatment Agreement Law.  It  took immediate effect.  The law requires prescribers to enter into an opioid patient treatment agreement before issuing the first prescription in a single course of treatment for chronic pain using any opioid-containing medication, regardless of whether the dosage is modified during treatment.

Among the new requirements, the Prescriber must: determine whether an individual has taken or is currently taking a prescription drug to treat a substance use disorder; have a discussion with the patient about the risks of addiction, and additional risks if the patient suffers from a mental health condition or substance use disorder; present non-opioid treatment options available; and discuss the dangers of taking a controlled substance containing an opioid with benzodiazepines, alcohol, or other depressants. The Prescriber must review with the patient, and both must sign, a treatment agreement containing a number of required elements, including the patient’s consent to targeted urine drug testing if medically necessary. The Prescriber must obtain written consent from the patient for the prescription, and record the consent on the treatment agreement. The treatment agreement must be maintained in the patient’s medical record.

The law exempts from these requirements medical emergencies, management of pain associated with cancer, and use in palliative or hospice care. Violations of the law may result in sanctions to the Prescriber’s license in accordance with the applicable professional practice act. The Act is effective immediately, and mandates that the Pennsylvania Department of Health issue regulations within 90 days of the Act’s enactment.  Contact me for a Patient Agreement Form.

Aside from these patient agreements, 35 Pa. Cons. Stat. § 52A03 (2016). Pennsylvania also amended its laws regulating opioid prescribing to minors in 2016. The amended statute prohibits prescriber from prescribing more than a seven-day supply of a controlled substance containing an opioid to a minor.  Requirements with the force of law: 35 Pa. Cons. Stat. § 873.3 (2016). As with minors, Pennsylvania also now prohibits prescribers from prescribing more than a seven-day supply of opioids to persons receiving care in emergency departments.

Reckless Prescribing and State Criminal Prosecution for Manslaughter

Every day medical practitioners confront complex and serious medical cases.  Patients and their doctors face death every day of the week. In this opiate use and abuse environment, death is one pill, snort, injection, toke away. Prosecutors have been turning to the distributors of the drugs that are killing our nation’s children, mothers, sisters, fathers, and brothers.

 

In one hand federal prosecutors are targeting the drug makers.  In the other hand, state and federal prosecutors are now targeting physicians whose care presents a conspicuous disregard of a substantial and unjustifiable risk of death.  Now, when patients die, the autopsy results are turned over to prosecutors who seek to unjustly and prematurely crucify every physician whose pain prescriptions may be part of a patients ultimate demise.

My last blog discussed federal mandatory minimum sentence enhancements for physicians convicted of violating federal drug laws which violations directly (medically) cause a patient’s death.  These physicians are exposed to mandatory minimum 20 years of incarceration.  That case discussed the United States Supreme Court case that defined medical causation in a federal criminal setting under specific death by prescribing statutes.Federal Mandatory Minimums in Prescription Death

The state courts and legislatures are also getting a piece of this action.  A recent New York Court of Appeals holding concludes doctors can face homicide charges, in certain circumstances, if the drugs they prescribed are used by one of their patients during a fatal overdose on the medication. Here the issue was the doctor was not charged under the prescription death criminal charge.  Rather, he was charged under a homicide manslaughter statute that did not include a requisite clear causation proof.  NY State Case: People v. Li — November 2019

 

At issue in the Li case is the NY State definition of recklessness:“A person acts recklessly with respect to a result or to a circumstance described by a statute defining an offense when [that person] is aware of and consciously disregards a substantial and unjustifiable risk that such result will occur or that such circumstance exists. The risk must be of such nature and degree that disregard thereof constitutes a gross deviation from the standard of conduct that a reasonable person would observe in the situation” (Penal Law § 15.05 [3]).

 

A conviction for reckless manslaughter “require[s] that there be a substantial and unjustifiable risk’ that death . . . will occur; that the defendant engage in some blameworthy conduct contributing to that risk; and that the defendant’s conduct amount to a gross deviation’ from how a reasonable person would act” (People v Asaro, 21 NY3d 677, 684 [2013], quoting Penal Law § 15.05 [3]). The conduct must be “the kind of seriously blameworthy carelessness whose seriousness would be apparent to anyone who shares the community’s general sense of right and wrong” (Asaro, 21 NY3d at 685 [internal quotation marks and citation omitted]).

The extreme facts of the case are important.  The physician’s office was only open one day a week, on the weekend, and did not require appointments. The doctor saw as many as 90 patients in a single day, charging $100 cash per visit.  The doctor did not verify the source of the patients’ pain complaints and conducted little to no physical examination of the patient.

 

Thereafter, the doctor prescribed heavy doses of whatever medication the patient requested. Certain patients were given prescriptions for a combination of medications that should not have been prescribed together. The jury convicted the physician of manslaughter after two patients died of opioid overdoses.

 

When the patients died, an investigation commenced focusing on the physician’s charting and prescription writing habits.  Current state of prescription drug monitoring programs and federal DEA prescription writing history for every physician in the country allows prosecutors to conclude whether or not a physician acted with reckless disregard of the substantial and unjustifiable risk that his prescription practices could result in an overdose or medical related death.

The physician argued he did not have the requisite mens rea (Latin for specific mental intent) to act recklessly against his patient’s safety because the drugs as prescribed would not have resulted in death if used as directed. The physician argued this that he could not have known either patient would abuse the medications.

The New York Court of Appeals rejected this argument under the facts as patently absurd.  “It is a direct and foreseeable result of defendant’s reckless conduct “that extra prescriptions or the copious amount of prescriptions written for each patient” obviously suggested the patient was not taking the medications as directed and, thus, it was reasonably foreseeable that the patient was abusing the prescriptions.”

The New York Court of Appeals did not limit It’s ruling to the facts of this specific case. In affirming the manslaughter conviction, the court affirms the proposition that physicians must comply with their prescribing responsibilities, state law on appropriate therapeutic parameters for prescribing controlled substance, and practice their profession responsibly and ethically.

The new burden of proof for criminal prosecution is recklessness in a physician’s prescribing of various medications that, when interacting together, can be said to be reasonably foreseeable to cause death.  In the context of physicians that write to many prescriptions for scheduled controlled substances in the absence of objectively verified medical conditions and conservative prescription writing practices, local prosecutors offices will be investigating that position.