Federal prosecutors in at least two U.S. Attorney’s Offices recently began a new and, in some ways, radical approach to attempt to combat the opioid epidemic.

In late 2018, the U.S. Attorney’s Office for the District of Massachusetts started issuing letters directly to a number of medical prescribers warning them that their opioid prescribing practices are a “source of concern.”

Similarly, the U.S. Attorney’s Office for the Northern District of Georgia (which includes Atlanta) sent notifications to numerous medical professionals it identified as having prescribed opioids “in significantly higher quantities or doses than their peers.” See U.S. Attorney’s Office Press Releases: U.S. Attorney Issues Warning to Opioid Prescribers (D-Mass.); Prescriber notification initiative for opioids (NDGA).

The letters, samples of which have not been made public by DOJ, are based on data gleaned from prescribers’ own records, which reveal that the physicians have prescribed opioid painkillers in notably high amounts or with unusual frequency.

Purpose Is Cautionary

DOJ’s stated purpose in issuing these warning letters is cautionary in nature: to “induce these medical professionals to take stock of their prescribing practices and make any necessary adjustments,” and to make the doctors “aware of their atypical practices, so that they can make informed decisions about whether their opioid prescriptions are for a legitimate medical purpose.”

This new practice by federal prosecutors raises a number of questions.

First, the practice is largely unprecedented, so there is little guidance on how, or if, the targeted prescribers should respond to the letters. Although at first blush, these opioid warning letters may resemble a traditional target letter, they are vastly different.

Target Letters

Federal prosecutors have the option of issuing a “target letter” to a “target” of an investigation, defined by the Justice Manual (formerly known as the U.S. Attorneys’ Manual) as “a person as to whom the prosecutor or the grand jury has substantial evidence linking him or her to the commission of a crime and who, in the judgment of the prosecutor, is a putative defendant.”

Prior to sending a target letter, the federal prosecutor and agents investigate and gather evidence through, inter alia, the issuance of grand jury subpoenas. However, both U.S. Attorney’s Offices engaged in sending the opioid warning letters have made clear in public statements that the letters are not a determination that the prescribers have violated the law.

Presumably, then, these U.S. Attorney’s Offices have not conducted any investigation, and the evidentiary basis on which these letters are issued, beyond a possible statistical anomaly in prescribing activity, is uncertain. It appears, therefore, that the primary reason for sending the letters is to use the power of the federal prosecutors’ letterhead to influence presumptively legitimate medical judgment about the appropriate treatment for pain.

Next Steps for Doctors

How doctors who receive these warning letters should react is not clear. At a minimum, it would seem prudent for any prescriber receiving a letter to retain counsel and conduct a review of his or her prescribing practices. Even if the review ultimately reveals no basis upon which federal prosecutors could bring charges, given the uncertainty and high stakes involved in this new practice, inaction is too great a risk.

Second, and relatedly, this practice raises concerns about whether federal prosecutors—who wield the considerable “stick” of criminal prosecution—should be issuing warning letters at all. If DOJ does not believe it has enough evidence to conduct a criminal investigation of these prescribers, then it should not issue these letters at all.

Rather, whether to issue these types of warning letters is best left to the discretion of the federal and state civil agencies and regulators who are tasked with overseeing medical professionals.

Past Efforts

Past efforts to curb the overprescription of opioids have not met with much success, which provides a partial explanation why these U.S. Attorney’s Offices have commenced this new practice. But it is inappropriate for federal prosecutors to be sending warning letters to medical professionals without having thoroughly investigated any potential wrongdoing.

Certainly, federal and state government agencies overall should take an aggressive approach to combatting the deadly opioid crisis, and many have devoted substantial attention and resources to addressing this epidemic.

For example, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act), passed last fall by a bipartisan Congress and swiftly signed into law by President Trump, underscores the federal government’s focus on fighting the illegal distribution, sale, and use of opioid painkillers.

However, the nascent practice of U.S. Attorneys’ Offices issuing opioid warning letters raises concerns about the appropriateness of DOJ’s choice of enforcement tools.

Federal prosecutors issuing warning letters to prescribers when it is unclear whether any investigating agency has conducted a thorough investigation bears telltale signs of possible prosecutorial overreach. Nevertheless, if this new practice garners results—fewer opioid overdoses and deaths or, ultimately, increased prosecutions—we should expect other jurisdictions to adopt similar tactics.

Author Information

Sarah M. Hall, a senior counsel in the Thompson Hine’s Washington office, is an experienced former federal prosecutor with significant experience prosecuting criminal health care fraud, money laundering, and kickback offenses. She was a member of the highly successful nationwide Medicare Fraud Strike Force.

Steven Block joined the firm’s Chicago office as a partner in 2018 after serving as a federal prosecutor and supervisor in the U.S. Attorney’s Office for the Northern District of Illinois, where he investigated and prosecuted cases involving, among other things, fraud, corruption, and narcotics offenses.

Peter Kocoras, a partner in the firm’s Chicago office, has more than 20 years’ experience. He concentrates on representing health care and other industry clients in complex cases in federal and state courts across the country.

Brian K. Steinwascher, an associate in the firm’s Business Litigation group in New York, focuses on white collar defense, internal investigations, and health care fraud.