Physicians and other health professionals face increased scrutiny from federal authorities, including the HHS, DEA, FBI, DOJ, and State Medicaid Fraud Control Units (MFCU) for overprescribing. During my representation of a substantial number of physicians and other health professionals against such charges, I have gained valuable insight into how federal agencies investigate and prosecute suspected drug trafficking by physicians. Through these insights I have been able to assist practitioners with compliance efforts to ensure that they avoid the perception of running a “pill mill” and successfully defend physicians when they are suspected of overprescribing.
What is a Pill Mill?
The term “pill mill” is not a medical term, but is one created by the media and federal agencies to describe a practice or physician engaged in drug trafficking, i.e. the prescription of controlled substances outside the usual course of professional practice and for no legitimate medical purpose. In the 1970’s when prosecutions under 21 U.S.C. 841 and 846 began, a physician would generally have to act in a very egregious manner to face prosecution as a “drug pusher” by prescribing to patients for no medical purpose. As federal law evolved and public scrutiny of physicians has increased, federal agencies have been broadening the definition of what constitutes a “pill mill.” Now, federal and state prosecutors are likely to deem a practice a “pill mill” when the practice fails to investigate patients who present to the practice with “red flags,” such as doctor shopping, traveling long distances, paying in cash, arriving in groups, requesting certain drugs, lack of adequate documentation, and use of illegal drugs. Unfortunately, many of these “red flags” are present in legitimate patients who experience legitimate pain, but struggle with substance abuse or hyper analgesia. Federal agencies are now more likely to prosecute simply because a physician ignores these “red flags.”
How Federal Agencies Investigate “Pill Mills”
The implementation of Prescription Drug Monitoring Programs (PDMP, MAPS, OARRS, E-FORCSE, KASPER, PMP, etc.) has provided a gold mine for the DEA and other federal agencies in the investigation of “pill mills.” Once the DEA receives a tip about a physician from other law enforcement, another physician, the public, or an informant that the physician is overprescribing, it will open up an investigation and initiate a review of the provider’s PDMP records. Obviously, this is problematic because PDMP records say nothing about the medical condition of the patient. Once a review is complete, the DEA will coordinate with local authorities and conduct surveillance of the practice to see how busy the practice is and look for out of state license plates in the parking lot. The DEA may then consider sending in undercover agents or informants (possibly existing patients asked to cooperate with local authorities). These patients will have an audio and video recording device and will seek treatment at the practice and record the visit. The undercover informants/agents will often complain of pain, but will attempt to exhibit “red flags.” They are likely to say they traveled from far away, will try to pay in cash, provide an inconsistent urine sample (negative for prescribed controlled substances), show doctor shopping on their PDMP reports, and ask for drugs using their street name – this is a very common tactic by the DEA and taught by the National Association of Drug Diversion Investigators.
The undercover informants/agents will return for multiple visits, given most physicians preform a more rudimentary examination during subsequent visits. If the physician prescribes controlled substances during these visits, the DEA is likely to send in additional agents/informants. The DEA may also attempt to interview patients and former patients and employees.
While this is not always done, the DEA will occasionally preform an “administrative inspection” under the auspices of the DEA’s regulatory authority to look at the practice and interview the provider. This is precisely why physicians should contact an attorney any time the DEA requests an interview or to inspect the practice. You can refuse inspection or ask the DEA to come back if you have obtained counsel, but you cannot refuse an inspection when presented with an administrative inspection warrant.
Following the investigation, the DEA and other agencies will seek a search warrant and search the practice. They are likely to show up in the morning when patients are arriving for the day in order to interview patients and employees at the practice. The DEA will seize computers, patient records, billing data, business records, cell phones, and any controlled substances on the premises. Generally, the Department of Justice prefers to issue an indictment before preforming the search warrant, but this is occasionally not done when the DEA has not gathered enough evidence during the investigation to indict, or the DEA believes emergency circumstances require that they perform the search warrant immediately.
How to Avoid Audits Investigation and Prosecution
A proper compliance program can assist you and your practice from the perception of unlawful prescribing. Our attorneys regularly assist physicians and other health professionals navigate the complicated web of DEA regulations to ensure compliance. Below are some tips to improve your practice and avoid scrutiny.
Physicians must implement thorough intake procedures. In any practice that prescribes controlled substances for the treatment of pain, the practice should have thorough intake procedures that require the patient to detail their pain complaint and medical history. Intake documentation should include a new patient questionnaire, consent for treatment, authorization for release of medical records, opioid agreement (if necessary), medical history questionnaire, and prior medical records should be requested prior to the visit or during the initial visit. Patients should be aware during their initial contact with the practice that they should arrive with relevant x-rays, MRIs, CT scans prior to their first visit. A Health Care Compliance attorney can assist you with creating intake documentation that will gather the required information to support the medical necessity of any prescriptions written.
Physicians must investigate non-narcotic therapies prior to prescribing opioids. The common consensus in the pain management field is that non-narcotic therapies should be attempted prior to the use of narcotic therapies. This may not always be the case when a patient faces a painful condition immediately requiring opioids. However, when possible, NSAIDS, muscle relaxers, physical therapy and other non-narcotic modalities should be prescribed. If alternative modalities are not appropriate, the reasons must be documented in the medical record. While many physicians determine non-narcotic modalities are unnecessary, they fail to document this, leading the DEA to conclude that this step was skipped.
A physician must perform a detailed physical examination. Often, physicians will perform a limited focused physical examination related to the patient’s chief complaint. This practice may be medically appropriate, but law enforcement and regulators are expecting physicians to do more than a limited focused physical examination. Physicians should consider providing a thorough examination of the patient on the first visit in order to identify other co-morbidities or alternative sources of the pain.
When medically appropriate, physicians should avoid providing a thirty-day supply on the first visit before receiving records. Often, patients will arrive without records substantiating their injury. When this happens, a physician is in a difficult position. He or she can either prescribe controlled substances, prescribe non-controlled substances, or refuse to prescribe altogether. When the patient has a condition for which pain medication is medically indicated, the physician should consider prescribing for two weeks until the patient can return with appropriate records or after the patient has had the ability to obtain an MRI, CT, ultrasound, or orthopedic consult.
Physicians must understand that when an audit or investigation is being conducted, their documentation and recordkeeping is what stands between them and administrative or criminal action. While all physicians likely understand the need for documentation, many disregard documentation standards because they believe an audit or investigation will never happen to them. However, regulatory audits and criminal investigations against Health Care providers continue to increase. Additionally, DEA inspections of physicians practices have continually risen for the previous five years.
Routine Auditing is Key to Success
There are other compliance measures that can be implemented in addition, such as urine drug testing, frequent monitoring of prescription drug reports (for the patient and the provider), and periodic record audits. Providers, especially those in the field of pain management, should have an independent compliance audit conducted of their pain management practice annually to ensure compliance with DEA regulations and avoid civil monetary penalties, administrative action, or even criminal charges.
Chapman Law Group routinely conducts compliance audits of physician’s offices and Health Care entities to ensure compliance with HIPAA, insurance conditions of participation, Medicare and Medicaid conditions of participation, Stark, Anti-kickback, and other areas of Health Care compliance. At Chapman Law Group we have skilled compliance attorneys who specialize in DEA, Medicare/Medicaid compliance, HIPAA compliance, and all other areas of Health Law. Avoid costly investigations, audits, and potential administrative or even criminal action by scheduling a compliance audit today – call (248) 644-6326.