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Dr. Nick Oberheiden
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100 FAQs: DEA Opioid Investigations

Categories: Health Care Law

DEA investigations

DEA Defense Attorney Dr. Nick Oberheiden

The practice of authorizing and dispensing controlled substances has dramatically changed since the Justice Department announced to fight the national opioid crisis by vigorously prosecuting prescribers and corroborating pharmacies across the country. The essence of the government’s claim is that many of the close to 50 billion annual dosages of prescribed controlled substances are medically unnecessary and thus violative of the Controlled Substances Act (CSA). Since the Justice Department’s announcement, physicians and pharmacy owners across the nation have been prosecuted and criminally charged in federal courts. Purpose of this FAQ summary is to provide answers to some of the most pressing and common questions in the context of current DEA opioid and narcotics investigations.

Visit the end of this blog post for recent case outcomes and disclaimer.

Featured by media stations in all 50 states for his federal litigation practice, health care fraud defense attorney Dr. Nick Oberheiden has vigorously (and successfully) protected the licenses, livelihood, and liberty of physicians and pharmacies in DEA, FBI, and IRS government investigations across the United States.

FAQs

Part I: Background Information About Current Opioid Investigations

What Is Drug Diversion?



Drug diversion describes the unlawful distribution of legally obtained medications. Unlike illicit drugs like cocaine or heroin, drug diversion in the context of controlled substances in form of pain medication assumes that the patient presents himself or herself with pain symptoms, receives a doctor’s prescription, and then trades or sells some or all of the pills unlawfully to a third-party.

What Is a Pill Mill?



The term “pill mill” is commonly used by law-enforcement (and the media) to describe a physician’s office or pharmacy that dispenses large quantities of medically unnecessary controlled substances. While there are no set standards or rigid criteria as to what constitutes medically unnecessary or excessive medications, the generic test applied by law-enforcement is whether the dispense of controlled substances falls within or outside the accepted standards of medicine as used under the Controlled Substances Act. What makes “pill mills” targets of criminal investigation is the medically inappropriate and unnecessary, ongoing or repeated prescribing of high dosage medications that are known to be particularly addictive.

What Is Prescription Fraud?



Prescription fraud is a generic term that is used to describe the issuance of controlled substance prescriptions that the government considers excessive and medically unnecessary and thus in violation of the controlled substance Act.

What is the DEA?



The Drug Enforcement Administration (DEA) is divided into 22 domestic regional field offices. The DEA investigates, often with other federal law-enforcement agencies such as the Federal Bureau of Investigation (FBI) and agents of the Office of Inspector General (OIG) on behalf of the Department of Justice. The current 22 regional field offices are located in: Atlanta, Chicago, the Caribbean, Dallas, Denver, Detroit, El Paso, Washington DC, Houston, Los Angeles, Louisville, Miami, New England, New Jersey, New Orleans, New York, Philadelphia, Phoenix, San Diego, San Francisco, Seattle, and St. Louis. Mission of the DEA is to investigate and combat all unlawful use, manufacturing, or distribution of drugs, be it illicit street drugs or drugs inappropriately prescribed by medical providers.

What Causes DEA Opioid Investigations?



Most opioid investigations originate from one of three events. First, the DEA uses its database and simply compares the number of your controlled substance prescriptions with other doctors of similar specialty in your area. Second, either through patient complains or a commercial insurance audit of your patient charts, the DEA begins to send undercover agents as “fake” patients to your office to see how “easy” it is to obtain narcotics. Third, the DEA becomes aware of your practice (for example through a False Claims Act investigation or a tip from a pharmacy), contacts former or current employees, and then uses confidential informants to gather information about alleged misconduct at your clinic.

Who Are the Targets of DEA Opioid Investigations?



The targets of current DEA administrative and criminal opioid investigations fall into three groups: (1) medical providers, (2) pharmacies, and (3) veterinarians. First, recent cases have illustrated that the government does not distinguish between physicians specialties but simply looks at the number of total issued prescriptions of targeted doctors (e.g. family medicine doctors, rheumatologists, internal medicine doctors, psychiatrists, nurse practitioners etc.), not the physician’s specialty. Second, pharmacy investigations and raids were first reported in Nevada and have since extended to pharmacies nationwide that have alleged illegal ties to prescribing physicians or that showed up as outliers with unusually high controlled substances fillings. Third, larger veterinarian clinics are on the radar for drug diversion caused by stealing employees and owners of injured animals.

Why Is the DEA Going After Veterinarians?



Veterinarian offices have become targets of DEA search warrants in several states, including, for example, in Chicago, Illinois. Just like physicians for human beings, veterinarians do administer pain medications to their (animal) patients. In particular large veterinarian clinics, surgery centers, and animal hospitals maintain narcotics for emergencies and postoperative use that attract desperate and addicted animal owners to engage in diversion, fraud, and abuse. Case law has shown how animal owners have engaged in veterinarian shopping to fraudulently obtain pain medications for their animals— with these narcotics ending up being consumed by the owners themselves. In addition to abuse by animal owners, the DEA has become aware of instances, in which staff members of vet clinics have stolen narcotics from the clinic’s secured medication storage units and thus imposed liability on the veterinarians, DEA license holders, and clinical owners.

What Are the Main Targeted States?



According to statistics, the rates of opioid prescriptions dispensed per 100 persons by dosage and type exceed the national average in a number of states. The states under particular government scrutiny are: Alabama, West Virginia, Arkansas, Tennessee, Mississippi, Oklahoma, Kentucky, Louisiana, South Carolina, Michigan, North Carolina, Oregon, Delaware, Missouri, and Nevada. Because the DEA applies a purely numeric data-driven approach when it comes to identifying their prioritized targets, high volume prescribing physicians and pharmacies in those states are most likely to be contacted by law-enforcement.

Which States Have the Highest Opioid Related Overdoses?



Approximately 90 people die in the United States of a drug related overdose every day. That number has gotten the attention of federal law-enforcement when it became clear that many of these fatalities are at least partially caused by high-dosage narcotics. One of the key selection criteria for the Justice Department and the DEA to prioritize opioid investigations is a look at the total number of prescriptions per physician. According to the DEA, the states with the highest rates of drug overdose deaths are: West Virginia, New Hampshire, Ohio, bring the island, Pennsylvania, Massachusetts, New Mexico, Utah, Tennessee, Connecticut, Delaware, Maine, Maryland, Michigan, Indiana, Louisiana, Arizona, and Oklahoma.

What Are Current Opioid Lawsuits About?



A number of cities, counties, and states have brought state and federal lawsuits against opioid manufacturers and drug distributors. Cities like Philadelphia, Dallas, and Chicago claim that pharmaceutical companies and large pharmacy conglomerates have caused or contributed to drug addiction, illegal drug use, and accidental overdoses resulting in damages and financial losses for municipalities, state owned facilities, and hospitals. In one of the largest of these class actions, a federal judge in Cleveland, Ohio has so far rejected almost all objections raised by the defendants to end or to limit the scope of these pending lawsuits; the case is scheduled for trial in 2019.

Do Physicians Have Exposure in Pending Civil Lawsuits?



Plaintiffs’ lawyers in civil lawsuits against drug manufacturers frequently also sue physicians arguing that it the physicians’ prescriptions and their alleged lack of professional care that have contributed to the current national epidemic. While these lawsuits are civil in nature, the true risk for physicians is to be forced to testify under oath in a deposition or in court about their prescription policies—with the DEA closely monitoring and observing these proceedings in an effort to build criminal cases based on the physicians’ testimony. Any physician sued in state or federal court for medication abuse and opioid mismanagement allegations should consult with an experienced DEA criminal defense attorney to make sure that the compelled testimony does not lead to accidental self-incrimination.


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Part II: Signs that You May Be Under DEA Investigation

What Are Signs that My Practice Is Under Investigation?



Signs of an investigation can stem from overlapping rumors or concrete actions by the government. Most people first become aware of an investigation when they hear rumors that agents have, for example, interviewed patients or former employees. While these rumors may or may not be credible at times, a pending investigation becomes obvious when your business receives correspondence from a private insurance company or a government agency. Common examples of subpoenas and written notifications are OIG subpoenas, Grand Jury Subpoenas, a Civil Investigative Demand (CID), a DEA patient file subpoena, as well as, not to underestimate, an audit request from commercial insurance carriers. A more dramatic way of learning about a pending case is when federal agents show up at your office to interview you or to execute a search warrant. If you experience any of these events, you must immediately consult with an attorney to avoid further investigation and criminal charges.

What Should I Do When a Commercial Insurance Carrier Wants to Audit My Patient Charts?



Many health care business owners grossly underestimate the investigative connection between commercial insurance companies (e.g. Blue Cross Blue Shield, Aetna, CIGNA) and the Department of Justice. The old assumption of federal law enforcement on the one hand and private insurance companies on the other hand has long been obsolete. Today, a great number of federal indictments rather exclusively claim private health insurance fraud. If your business receives an audit request from a private insurance company targeting your prescription policies or your chronic pain treatment protocols, it is absolutely possible that an unfavorable audit outcome may be shared with the U.S. Attorney’s Office. The best practice is to visit with an attorney with the experience and track record of settling patient chart audits and subpoenas quickly and efficiently before a criminal referral will be made—regardless of the error rate and irrespective of how negative the audit outcome may be.

What Should I Do When the DEA Shows Up at My Pharmacy?



When DEA drug diversion investigators arrive at your pharmacy, you should immediately consult with experienced attorneys. Federal law entitles the DEA to inspect a pharmacy at any time during regular business hours as long as such inspection does not interrupt the pharmacy’s business operations. Because a pharmacy’s compliance is mandatory, you should not engage in a confrontation with the auditors or refuse entry as such reaction could prompt the investigators to obtain a criminal search warrant. Instead, you should seek advice from experienced attorneys right away. The involvement of respected lawyers will typically create a more pleasant and functional relationship with the auditors. Quite often, knowledgeable DEA defense lawyers will be able to secure a 48-hour extension before the audit can begin. Such negotiated delay can be based on a number of reasons and it allows the pharmacy, together with its attorneys, to prepare the upcoming inspection and to fix potential shortcomings in the meantime.

What Should I Do When I Receive a DEA or OIG Subpoena?



Immediately call an experienced attorney. If your business is targeted by a government subpoena, you must assume that there is an advanced, ongoing investigation against your business that must be stopped as quickly as possible.

Do I Need to Comply With a DEA or OIG Subpoena?



Yes, government subpoenas are enforceable in court. More important than complying with the subpoena is the intervention of a health care fraud defense attorney. Your lawyer must immediately open a line of communication with the prosecutor to discuss the goal and scope of the investigation. Ultimately, these discussions can lead to a meeting with the prosecutor, in which a case resolution can be negotiated.

What Is Required for the DEA to Obtain a Search Warrant?



In order for the DEA to obtain a search warrant, the investigators must convince a federal judge that there is “probable cause” to find evidence of a crime at the location to be searched. In practice, investigators will collect information from informants, their own observations, and public databases of prescription volumes, in an effort to put together an affidavit outlining the alleged crime and why evidence of the crime is likely located at the targeted office. The “probable cause” standard can also be fortified by a detailed, written synopsis of conducted witness interviews, such as from current or former office staff.

Are Opioid Related DEA Search Warrants of Pharmacies and Physician Offices Common?



Yes, DEA search warrants have become a powerful tool for the government to get rapid access to patient files, financial records, and corporate documents. Previously, the more common practice was for the DEA to issue a subpoena requesting specifically identified charts and documents. Today, the government simply takes it all, seizing patient files and entire computer systems from the clinic premises leaving the raided office in a state of chaos.

Should I Surrender My DEA License Upon an Agent’s Request?



No, you should not surrender your DEA privileges unless a qualified attorney recommends or advises to do so. These days, physicians feel pressured by DEA agents requesting a voluntary surrender of the physician’s DEA license under the false pretense that such surrender will protect the doctor from further investigation. The truth is that there is almost never a correlation between giving up a DEA license and closing an investigation. The DEA license is issued and revoked by the Drug Enforcement Administration, while the decision to pursue or end a civil or criminal investigation lies exclusively with the local U.S. Attorney‘s Office and the Justice Department. Experienced attorneys will use a DEA license as leverage in case there is a need to actually negotiate a reliable and final investigation outcome. Promises made by a DEA field agent to a physician simply do not have the same level of reliability as promises made by a prosecutor to a defense attorney.

What Should I Do When I Notice Compliance Problems?



When you notice compliance problems or if you realize that with today’s knowledge and understanding of opioid investigations you may have treated some patients in the past differently, you should immediately consult with an attorney to get concrete advise how to improve and protect your practice. Everyone is eager to make changes after the DEA and the FBI show up at an office. The key is to prevent any encounter with law-enforcement and to organize your practice to the highest compliance levels before you receive a visit or subpoena from investigators.

What Are Potential Outcomes if My Practice Is Under Investigation for Opioid Fraud?



Opioid investigations can run the entire spectrum from no liability, to administrative penalties, to criminal prosecution. The key in each case is to consult with experienced attorneys with specific track records in DEA medication cases as early as possible to execute effective and proven defense strategies.


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Part III: How the DEA Investigates Opioid Fraud

Who Investigates Opioid Fraud?



The Department of Justice, local U.S. Attorney’s Offices, federal and state prosecutors, the Drug Enforcement Administration (DEA), the Federal Bureau of Investigation (FBI), the Office of Inspector General (OIG), and the Internal Revenue Service-Criminal Investigation (IRS-CI) are the main agencies to investigate prescription abuse and opioid fraud.

Should I Allow Agents to Interview Me at My Office?



Absolutely no. When DEA or FBI agents show up at your office or your house, all of your alarm systems must go off. While it is tempting to engage in a conversation with the agent (especially when they assure you that they just have a few questions and that the case is not about you, and you feel like you have nothing to hide because you did not do anything wrong), the only correct advice is to not discuss anything with the agents and to politely decline the interview request. Why? First of all, if federal law-enforcement takes the effort to visit you, you must assume that you are a person of interest of a federal criminal investigation. Second, anything you will share with the agents will be held against you and is the equivalent of testifying in court. Third, while it is a federal felony for you to withhold, misrepresent, or lie about material facts in the presence of a federal officer, the agents themselves can and will lie to you by downplaying the interview in order to break the ice and to make you chatty.

What Is the Significance of a Search Warrant?



A search warrant is a meaningful event in a federal criminal investigation. Unlike a subpoena or an audit request, a search warrant involves and requires a federal judge to agree with the investigators that a crime has probably occurred. Also, in terms of timing, a search warrant is typically the last preparatory step before criminal charges will be filed. What the government really tries to do when executing a search warrant is to find documents and information that confirms the assumption of criminal conduct and to secure evidence sufficient to convince a grand jury to issue criminal charges based on the documents seized, reviewed, and presented.

What Is the Role of the Grand Jury in Federal Criminal Cases?



Pursuant to the Fifth Amendment to the U.S. Constitution, the role of the grand jury in a federal criminal case is to determine whether or not to bring formal criminal charges against a targeted individual or company. The grand jury is selected similar to a regular trial jury. A grand jury consists of 16 to 23 people, who convene typically every two weeks somewhere within the local federal courthouse. Because criminal defense attorneys have no right to access the grand jury deliberations and thus no opportunity to introduce exonerating information in defense of a target, the government has a significant advantage by presenting a one-sided story.

What Is a Grand Jury Subpoena?



Subpoenaed documents are key components for a grand jury to reach their decision whether or not to charge somebody with a crime. The way for the grand jury to obtain such documents is to issue grand jury subpoenas to individuals and companies that are expected to have information about a particular case. For example, if a medical business is under investigation for billing fraud, outside vendors of that medical practice, such as the utilized outside billing company, could receive a grand jury subpoena requesting detailed billing and patient records with respect to the targeted medical business.

Are the DEA and the Medical/Pharmacy Board Working Together?



The DEA and state medical boards are working closely together and will exchange information and coordinate the status of an investigation in some, but not all states. For example, in New Jersey, Pennsylvania, and Virginia, medical boards and DEA agents have built close relationships and often work as teams, while in other states investigations are exclusively handled by law-enforcement without integration of medical board or pharmacy board investigators.

Will the DEA Report Me to the Medical Board?



The DEA will report alleged misconduct to your licensing board in one of two instances. One, the government believes that your practice of issuing high dosage prescriptions constitutes a threat to public safety. Two, the government decides to indict you with federal felony charges.

Will the DEA Record My Conversations?



Recorded conversations have become more common in white-collar investigations in recent time. Recordings occur in two situations. First, someone that you trust or want to do business with may work as an informant for the government and will attempt to entice you into admitting criminal misconduct—for example, to avoid criminal prosecution against himself. Second, because the government increasingly uses “fake” patients, undercover agents or confidential informants may record your interactions with them at your office.

What Types of Financial Relationships Between a Referring Physician and a Pharmacy Are Prohibited Under the Anti-Kickback Statute?



The federal Anti-Kickback Statute prohibits certain types of financial business relationships between people that have the ability and are in a position to refer patients and a business partner (e.g. hospital, pharmacy) paying or attempting to pay remuneration for such referrals. Kickbacks are never a one-way street and always involve two parties. Both, the paying and the receiving of anything of value constitute a federal felony if the deal directly or indirectly involves patient referrals. In the context of opioid fraud, the government will look for referral patterns and potential compensation arrangements between referring physicians and a pharmacy.

Are Pharmacies Required to Report Suspicious Prescriptions?



Yes, pharmacies are required to report suspicious prescription practices such as routine or automated fillings of high dosage opioids, potentially forged physician signatures, and other forms of drug diversion. If your practice receives a letter from a pharmacist-in-charge inquiring about your prescription habits or articulating concerns, you should immediately visit with an attorney to investigate and fix potential problems before the DEA gets involved.

Are Physicians Liable for Forged Prescriptions?



Yes, liability may arise if the forgery was made possible due to negligence or recklessness. If, for example, a physician shares access to prescription pads with his staff or allows his/her signature to be stamped or used electronically, the physician may well be civilly and criminally liable for forged prescriptions.

Are Physicians Liable for Stolen Prescription Pads?



Yes. Physicians with DEA privileges are required to keep their prescription pads and sample medications in a secure, locked storage unit with access limited to the prescriber himself or herself. Medical providers acting contrary to these mandatory safeguards may be subject to federal penalties, a loss of their DEA license, and possible prosecution.

What Happens in an Opioid False Claims Act Investigation?



The False Claims Act penalizes the submission of false or fraudulent claims to insurance companies or federally funded programs. False or fraudulent in the context of opioid investigations can be billing for services (e.g. physical examination, consultations with patients etc.) that did not occur. A claim can also be fraud if prescriptions are administered or authorized that turn out to be medically unnecessary. False Claims Act violations can be civil or criminal in nature and expose the responsible party to monetary penalties and even criminal prosecution.

How Many Medical Providers Have Been Charged with Felonies for Opioid Fraud in 2018?



Lacking official statistics, according to media reports, approximately 100 physicians have been criminally charged in recent months with hundreds of civil and criminal prosecutions against pharmacies, pharmacy owners, physicians, nurses, nurse practitioners, and health care business owners pending nationwide.

How Many Medical Providers Could Be Prosecuted Until 2020?



Listening closely to the Attorney General and serving on the defense frontline of current investigations, an estimated 1,000 physicians and pharmacy owners may be prosecuted for pain medication and opioid fraud over the next two years.


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Part IV: Defense Strategies

What Is the Most Important Thing to Do to Defend Against DEA, OIG, FBI, and IRS Opioid Fraud Investigations?



Nick Oberheiden has successfully defended physicians and pharmacies against opioid and health care fraud investigations across the country. The key is to understand health care laws and to have the skillset to lead negotiations with federal prosecutors and investigators—and to intervene as early as possible into the government’s case.

What Are Proven Defense Strategies in Opioid Fraud Investigations?



Nick Oberheiden has convinced government prosecutors and DEA agents in a plethora of cases that a) his client’s prescriptions were medically necessary, b) his client practiced within the accepted standards of medicine, c) his client had no intent to violate the law, d) his client has demonstrated sufficient compliance efforts to prevent drug diversion, e) the government’s search warrant was premised on wrong assumptions, f) the government’s search warrant resulted in no findings, g) renowned experts confirmed the client’s compliance with ethical obligations, h) the government’s expert lacks the necessary qualifications, and many more. Ask Nick directly for a case specific analysis.

How Does the Government Determine Which Prescriptions Are Medically Necessary?



Medical necessity is among the biggest battles in every DEA opioid investigation. Although prosecutors know as little about medical necessity as defense attorneys, almost every government agent and government lawyer will claim that the defendant’s prescriptions were excessive and not medically indicated. The true solution to the mystery of medical necessity is not for blinded lawyers to engage in the unauthorized practice of medicine, but for an experienced defense attorney with ties and connections to renowned medical experts, to obtain a high-level, professional analysis of the targeted physician’s prescription practice.

Is My Phone Wire-Tapped?



One of the most common concerns for anyone under actual or perceived investigation by the federal government is the question of wiretapping. Against common misconception, the government’s authorization to conduct extensive surveillance and even tapping and interfering into phone systems is subject to heightened legal obstacles and remains limited almost exclusively to organized crime cases, investigations involving national security, gang violence, terrorism, kidnapping, and similar (violent) crimes. Subject to few exceptions, the chances that your phone is wiretapped are very slim when your case centers on prescriptions or general health care fraud.

Can I Discuss My Case with Friends and Family?



No, you should not discuss details of your case or admit wrongdoing in front of anyone except for your lawyer. The natural tendency for people is to chat and to talk and to share their feelings and concerns with trusted and loved people. If you are under government investigation, however, you should put protection above communications and refrain from texting, emailing or discussing your case with anyone except for your trusted attorney of record. Text messages and emails can be subpoenaed and, if deleted, restored. More so, the person that you share thoughts and information about your case can be compelled to testify about your conversation with him/her unless that person is your attorney.

What Is the Attorney-Client Privilege?



The attorney-client privilege describes the protected confidentiality between an attorney and a legal advice-seeking client. An attorney must not disclose anything that the attorney learns during the representation of a client to anyone and no court can force an attorney to testify about legal advice given to a client unless an exception applies.

Is the Attorney-Client Privilege Absolute?



No, there are two main exceptions to the attorney-client privilege. First, the privilege may be jeopardized if the client shares legal conversations the client had with an attorney to a non-attorney third-party like a friend, and office manager, or a business affiliate. Second, the attorney-client privilege does not protect clients who are seeking legal advice to commit a crime.

Are My Conversations with My Spouse Protected?



In general, yes. Parallel to the attorney-client privilege, spousal immunity is a second, recognized form of confidentiality in a criminal case. The scope of the immunity is simple. Anything you share with your spouse about a legal issue is protected. As long as you are married at the time of the confidential conversation, your spouse cannot be compelled to testify against you. However, and here is the risk, your spouse may always voluntarily disclose all conversations to the government at the spouse’s discretion. That is a risk factor, in particular if the marriage results in a contested divorce.

When Does the Spousal Immunity Not Apply?



Just like any legal privilege, there are exceptions. The spousal privilege is most frequently challenged if the government claims that the protected spouse is a potential co-conspirator, who knew for a long time that a crime was occurring. The classic illustration of that objection is when the spouse has some functions or duties at the targeted office by, for example, working at office as an officer manager or helps the business with accounting services.

Are My Conversations with My Accountant Protected?



No, federal law does not protect conversations between an accountant and a client and all records in the possession of an accountant, including confidential tax returns and financial information, can be subpoenaed by the government.

What Is the Worst-Case Scenario in a DEA Opioid Investigation?



The worst-case scenario in a DEA investigation is that you will lose your medical license and will go to federal prison. Recent examples have exemplified the aggressiveness with which the government is prosecuting alleged opioid fraud. In several cases, the government has tried to secure life sentences against physicians for prescribing controlled substances to patients that accidentally died of a drug overdose. About 90 people die each day in the U.S. due to drug overdoses, some of which are contributed by pain medications. Equally horrific, several states have charged physicians with “homicide” for allegedly causing or contributing to the death of a patient under that doctor’s medical care.

Who Is the DEA Using as Confidential Informants?



The DEA is using confidential informants to gather information and evidence about targeted physicians’ offices. Today, many opioid related indictments and search warrant affidavits reference the contributions of a physician’s office manager, medical assistant, or front desk staff that the FBI or the DEA convinced to serve as informants to secretly provide documents, impressions, observations, pictures, and recorded conversations leading to criminal allegations of pill mill operations. Every clinic owner and every practicing physician should act extra professional and extra diligent when it comes to patient and staff member interactions at all times and should avoid jokes, casualty, or impressions of unprofessionalism.

Is the DEA Using Undercover Agents as “Fake” Patients?



Yes, besides staff members serving as confidential informants, the DEA frequently uses its own investigative agents to pose as “fake” patients. These patients are hard to identify because they are not just trained to appear like regular, normal patients, but they are also often using aliases with specially created health care insurance coverage (and not the otherwise applicable Department of Labor coverage typically used for federal employees). Mingled with regular patients, these undercover agents will visit the practice in an unsuspicious frequency, use recording devices, and hidden cameras to capture specific misconduct or general impressions of a “pill mill” operation. For example, in several cases, undercover agents reported pre-signed prescription pads, office staff selling prescriptions in exchange for cash, lack of medical examination or supervision, and similar characteristics of improper handling of controlled substances.

What Is the Statute of Limitations in Health Care Cases?



The general Statute of Limitations for health care fraud is five years. However, the statute enumerates several exceptions allowing the government to charge alleged offenses that have occurred more than five years ago under certain circumstances. Because federal cases tend to be complex and take years to investigate, most federal criminal charges will claim misconduct dating back not weeks or months but typically several years ago. For example, for someone to be charged with health care fraud in late 2018, the indictment would likely alleges fraud occurrences somewhere between 2014-2017.

What Is the Main Goal When Defending Against the DEA?



Priority in every DEA case is to avoid criminal charges and to protect the provider’s professional license. Even though many DEA investigations begin as a criminal case, experienced attorneys, if engaged early in the case, are often able to use their health care law defense expertise to convince DEA agents and federal prosecutors to convert a criminal case into a civil liability matter. The longer an investigation has been pending without forceful objection by counsel, the more difficult it is to turn a criminal case into a civil case. In other words, if you visit with an experienced attorney at the earliest indication of an investigation against your business, chances of avoiding criminal charges are disproportionately higher than you waiting until after a search or arrest warrant has been executed against you.

Why Are IRS Agents Involved in My Case?



If IRS agents are involved in a narcotic search warrant or an opioid investigation that means that the government expects you to have either committed money laundering or tax fraud. Because private pay patients can contribute large amounts of cash, IRS agents will typically subpoena your tax returns to see if your reported income matches the calculations of health insurance and federal program reimbursements in addition to monies received from private pay patients. What you should avoid under all circumstances is a two-front war against the DEA for opioid fraud and the IRS for tax evasion. Help is simple and effective to avoid such a situation.

Will I Go to Jail If the DEA Investigates My Practice?



DEA narcotics investigations do not necessarily result in jail time or criminal charges. The key to a successful case outcome is the timing and the experience of an intervening defense attorney. The sooner a lawyer with substantial experience of handling FBI and opioid investigations can contact, speak with, and find a resolution with the high-level decision makers, the more likely it is to avoid fines, charges, and public humiliation. In fact, almost every DEA search or arrest warrant is the consequence of failed legal representation and the defendant’s ignorance of the signs (e.g. patient audit request, government subpoena, attempt by law-enforcement to interview witnesses etc.) that predate criminal events and court intervention. The past success record of the lawyer of avoiding fines and criminal charges should be an essential element of your interview questions before hiring any attorney.

I Am not a U.S. Citizen: Will I Be Deported?



Non-U.S. citizens are particularly exposed in criminal cases. You will not be deported unless you plead guilty to or are convicted of an aggravated felony. Health care fraud is an aggravated felony. Please seek legal advice right away to coordinate immigration and criminal defense strategies.

What Are the Consequences of Pleading Guilty?



The consequences of pleading guilty can be severe and may affect your professional license, your ability to work in the health care industry, and your freedom. Because virtually all state medical and pharmacy boards have a mandatory provision to disbar convicted felons, medical providers will risk losing their professional license if they admit to a federal felony such as health care fraud or are convicted at trial. In addition, the guilty plea typically entails a prohibition to work in the health care industry or to bill Medicaid and Medicare services. Previously authorized providers will be excluded by CMS. Finally, a guilty plea must be carefully reviewed prior to acceptance in order to understand the framework of the potential criminal penalty. Some plea agreements will have a cap and define the maximum sentence a defendant could possibly receive at sentencing in court, while other pleas only contain an agreement as to the facts, the nature of the offense, and the defendant’s guilt.

Should I Plead Guilty or Go to Trial?



The decision to plead guilty or to present your case to an unbiased jury at trial is one of the most difficult decisions in any criminal case. Experienced attorneys, familiar with all facts, good and bad, ultimately must decide with their client whether at least one out of twelve jurors would disagree with the government’s story. The decision typically comes later in a case when all the evidence and facts have been established and evaluated. Importantly, the pressure from the government to force you into a plea by threatening more or additional charges if you go to trial should not be the true factor for you to surrender your rights and accept a plea. If you can’t honestly say in front of a federal judge and under oath that you did something wrong and that you did so with criminal intent, you shouldn’t plead guilty.


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Part V: How Can I Protect My Business?

How Can I Protect My Practice from a DEA Investigation?



The best way to protect your practice against any encounter with law-enforcement is to be vigilant when it comes to prescription policies and your handling of controlled substances. If you regularly prescribe pain medications, you should visit with an experienced attorney who is qualified to analyze your practice and able to review sample patient charts in order to assess whether or not you may have any exposure in light of current opioid audits and investigations.

How Can I Demonstrate that I Don’t Have Any Criminal Intent?



The government won’t take an x-ray of your brain to see whether you had any bad intent. The burden is on you. You must demonstrate through your documentation and your operations that nothing is more important to you than complying with state and federal laws.

What Is the Purpose of an Opioid Compliance Program?



One way to demonstrate your efforts to be compliant is to implement an opioid compliance program at your pharmacy or clinic. Compliance is typically a three-step process: establishing a program, monitoring compliance, and enforcing compliance. Consult with health care fraud defense attorneys which program may best fit your practice.

What Is a Prescription Contract?



All physician offices that issue any form of prescriptions should have all patients sign a Prescription Contract at the first office visit. The contract will legally bind a patient to follow the office’s guidelines, to adhere to the physician’s orders and instructions, and set clear demarcation lines of permissible and tolerable as well as prohibited patient behavior.

What Happens During an Internal Investigation?



The best preventive defense strategy for any pharmacy or physician’s office potentially or even remotely exposed to DEA inquiries is to have experienced attorneys conduct an internal investigation, also known as a voluntary self-audit. Purpose of the audit is to identify and fix operational and legal issues instead of (or before) the government may detect them. Prosecutions of health care businesses that have conducted a professional self-audit are very rare, among other reasons, because a voluntary self-investigation ostensibly demonstrates your intent to do things the right way and not to tolerate any known mistakes.

What Are Acceptable Amounts of Pain Medications?



There are no firm guidelines under the federal Controlled Substances Act that would allow prescribing physicians or pharmacies to obtain reliable orientation when it comes to the acceptable amounts of pain medications. However, an analysis of current opioid related indictments and a plethora of negotiations with prosecutors and government experts in pending DEA investigations allow attorneys like Dr. Nick Oberheiden to conclude that the government strongly disfavors the routine prescriptions (and auto refills) of high-dosage narcotics mixed with other controlled substances creating powerful cocktails of Schedule I, Schedule II, Schedule III, and Schedule IV combinations. For example, in one recent case, the government considered the following prescriptions sufficient to claim lack of medical necessity and to federally indict the medical provider: Percocet 10/325 mg, 120 pills; Oxycodone 15 mg, 60 pills; OxyContin 15 mg, 60 pills; Oxycodone 30 mg, 60 pills; and Zanaflex 4mg, 90 pills.

How Can I Prepare My Business for a Worst-Case Scenario?



Generally speaking, the best practice for any business is to have comprehensive policies in place that address in detail what to do during a search warrant or in case of any other government intervention. These written policies should address concrete procedures of how to respond to law-enforcement. The policies should further identify one or two individuals in charge of such a response as well as communication lines with pre-selected, standby attorneys. Rather than selecting and educating previously unknown attorneys during an ongoing crisis situation, it behooves business owners to have counsel familiar with the particular business operations (and the people running the company) preselected so that no time needs to be spent or wasted when time is truly of the essence.

What Is the Purpose of Having Prescription Policies?



Every prescriber of controlled substances should have a canon of policies and protocols that make it ostensibly clear under what conditions and circumstances patients may qualify for obtaining a controlled substance. These policies will address the valid alternatives to medication management, the use and integration of physical therapy, injections, radiology updates, counseling, and other elements of an interdisciplinary pain management approach. Similarly, the protocol should address the maximum levels of scheduled drugs that patients could expect from that prescriber.

What Should My Prescription Policies Emphasize?



Your prescription policies should emphasize your intent to comply with state and federal regulations and clearly define your dispensing policies when it comes to controlled substances. The prescription policies should be publicly available on your business’s website as well as acknowledged and signed by your patients at the first office visit. Supplementing the prescription contract that each of your patients should be required to sign, the prescription policies address under what circumstances prescriptions or refills can be called in, what happens in case of lost prescriptions, how patients can obtain their medication from the pharmacy, and who, in general, qualifies for narcotics and other pain medications.

May I Prescribe Controlled Substances to Family Members?



No, most state laws (e.g. New Jersey, New York, Virginia etc.) prohibit most types of prescriptions to immediate family members. Immediate family members are typically listed as spouses, children, parents, grand-parents, siblings, aunts, and uncles. State laws vary.

May I Prescribe Controlled Substances to Staff Members?



No, if not prohibited under state law, you may be accused of a conflict-of-interest if you build a doctor-patient relationship with your subordinates.

What Type of Doctor-Patient Relationship Is Expected When a Patient Receives Controlled Substances Prescriptions?



At an absolute minimum, prescriptions should never be issued without a physical exam and a face-to-face consultation between doctor and patient. The higher the dosage, the more testing and examinations are expected.

What Are the 10 Most Dangerous Drugs in America?



According to addiction experts, the 10 most dangerous drugs in America are: opioid painkillers, heroin, cocaine, fentanyl, methadone, alcohol, oxycodone, ketamine, benzodiazepines, and tobacco.

How Do Patients Abuse Painkillers?



There are three classic ways how patients may abuse painkillers. Patients may take a dose other than prescribed, take someone else’s medicine, or take prescription medicine to fortify the effects of other drugs or in a way to get high.

Why Did the Government Declare an Opioid Epidemic?



The federal government (and a number of states) declared a national opioid epidemic because of the high percentage of prescriptions abuse and an opioid-related overdose rate of approximately 33,000 people per year.

How Many Americans Are Estimated to Abuse Opioids?



Approximately 2-3 million Americans are considered opioid abusers.

What Are the Most Monitored Prescription Opioids?



The DEA monitors the administration of prescription opioids with unprecedented scrutiny. Among the most investigated opioid prescriptions are: hydrocodone (OxyContin, Percocet, Vicodin), oxymorphone (Opana), morphine (Kadian, Avinza), codeine, and fentanyl.

How Can I Prevent a DEA Interest in My Practice?



The safest way to avoid the DEA being interested in your practice is to reduce (or avoid) the issuance of controlled substances prescriptions. Equally important to prescribing less and reducing your maximum amounts of heavy narcotics, is the overall approach you apply to pain management. The government expects an interdisciplinary, highly individualized and patient-tailored treatment protocol that incorporates and orders psychological counseling, physical therapy, surgical referrals, pain procedures, and any other treatment form designed to wean down the patient’s current medication levels. In terms of patient compliance, physicians that routinely prescribe controlled substances (e.g. to chronic pain patients) ultimately must make a decision to either discharge noncompliant patients or to risk becoming a government target.

How Important Are Urine Drug Tests for Purposes of Opioid Compliance?



Since you can’t x-ray your patients’ brain to see if they plan on following your medication directions, you are left with monitoring narcotics compliance through urine drug testing. Doing so offers three advantages. One, toxicology drug test screenings and confirmations are the most objective way to make sure your patients are not doctor shopping or otherwise engaged in diversion. Two, the demonstrated compliance effort of testing and monitoring will be noted in the patient’s file and helps justifying responsible drug administering. Three, those patients that refuse a UDT or fail the test have violated their Prescription Contract with you and must be responsibly discharged. In terms of frequency, testing should be left to the doctor’s discretion and may vary among patient genders, patient age groups, the patient’s history of illicit drug consumption, and the overall patient susceptibility for strictest compliance. For most patients, a random drug test 3-4 times a year shall suffice.

Is It Legal to Accept Cash Patients?



While it is perfectly legal to accept cash paying patients, physicians should recognize that private pay patients can create unwanted exposure. With often-limited financial resources, cash patients are less likely to be compliant with those treatment regimens that the government expects in order to justify the issuance of controlled substances. Paying out-of-pocket for psychological counseling, chiropractic or physical therapy, toxicology tests, or expensive pain procedures is simply not affordable for a majority of private pay patients. And here’s the dilemma. The patients’ financial limitations and inability to follow doctor’s’ orders may force a clinic to discharge some of these patients, even those with a history of compliance.

Do Private Pay Patients Pose a Compliance Risk for My Practice?



One of the biggest challenges for every provider dedicated to caring for chronic pain patients is whether or not to accept so called private pay patients. There are many reasons why a patient may lack health insurance (e.g. due to a loss of employment benefits and or other valid reasons). However, seeing through the eyes of government investigators, cash paying patients are the number one cause of unlawful opioid drug diversion. Private pay patients are typically not registered with and monitored by state or federal reporting organizations making their medication habits more difficult to supervise and monitor, in particular for those patients who travel to physicians in different states or who refuse or are unable to comply with urine drug tests and interdisciplinary treatment regiments.

When Are Physicians Liable for Patient Misconduct?



Drug diversion can create civil and criminal liability for physicians if there are no precautions or mechanisms in place designed to prevent non-compliance with the physician’s order. The most effective way to control and suppress diversion is urine drug testing. Modern toxicology laboratories are able to detect missing as well as added ingredients in urine samples and can thus determine whether or not the patient applied the medically ordered prescriptions amounts. Put differently, if a patient’s drug test is inconsistent with the ordered medications, the physician may be required to discharge the patient or otherwise risk exposure for participation in drug diversion.

When Should I Discharge a Patient for Non-Compliance?



You should discharge patients when they are not compliant with your treatment orders or if they fail a drug urine analysis test. Although most physicians would give patients caught with marijuana a second chance, this leniency should be re-thought and revisited given that marijuana and similar drugs are strictly prohibited under federal. In other words, if your practice is, for example, in Colorado, where the consumption of certain drugs is not prohibited under state law, the test for you in terms of compliance is whether federal law (and the DEA) would allow for the consumption of the drug found in the urine test. When it comes to controlled substances’ compliance, “second chances” create a real legal risk for a physician, which should be carefully weighted in light of the aggressiveness of current Controlled Substances Act cases.

Should I Be Concerned About Patient Abandonment?



Yes, patient discharges must not result in patient abandonment. Physicians have an ethical obligation to care for their patients, including those that are to be discharged. When a discharge occurs, a physician must exercise good judgment to ensure that the patient is not left in a dangerous medical condition or at risk for life-threatening withdrawals. The proper discharge protocol must give each patient contact information of nearby hospitals, names and addresses of new medical providers, and other important information to safely transition the patient to another provider.

Should I Report Discovered Issues to CMS?



Unfortunately, the CMS self-disclosure reporting is often an inadequate tool to address and rectify discovered errors for health care businesses. Although experienced health care defense lawyers like Dr. Nick Oberheiden have utilized the disclosure protocol to the advantage of his clients, each disclosure comes down to a delicate risk assessment. The disclosure requires a sworn statement that summarizes the scope and extent of the disclosed mistakes; but it also requires a sworn certification that the revealed errors represent the totality of mistakes. The general problem with the self-disclosure is that the government does not offer any criminal immunity. To the extent the disclosure can be interpreted as a self-incrimination, the client essentially waives all constitutional privileges and rights leaving the decision to criminally prosecute the reported misconduct entirely up to the government.

What Should I NOT Do When I Notice Compliance Problems?



What you should not do when you experience drug related compliance concerns is to discuss those with anyone except for an attorney. Loose lips sink ships!


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Part VI: Selecting the Right DEA Defense Attorney

When Should I Consult with an Attorney Regarding My Prescription Concerns?



Immediately! You should consult with an attorney immediately if you have concerns about your past or current prescription practice or if you experience any signs of an investigation, be it an audit, be it agents showing up at your office, or be it a subpoena issued against you or your practice. The more time you give the government to investigate you, the more difficult it is for an attorney to effectively intervene. Put differently, avoiding liability and criminal charges is substantially more feasible than dismissing an already issued indictment. Put a trusted lawyer to work on your case right away and don’t wait until you actually have to defend yourself. Invest into your license and future, today!

How Much Experience Should My Lawyer Have?



Just like you would not necessarily choose a dentist to operate on your spine, you should also not hire just anyone with a law license. DEA and FBI opioid investigations are not the time to experiment and the federal justice system will sanction false strategies and ineffective legal advice. A good way to narrow the scope is to identify those lawyers that limit their practice to health care fraud defense cases. Only those criteria ensure that your lawyer understands the relevant health care statutes and, at the same time, offers you a track record of successful negotiations with the DEA, the FBI, and the Department of Justice. In general, you should ask the following questions:



  • How much of your practice is dedicated to federal criminal defense?

  • How many health care fraud defense cases have you handled?

  • What is the percentage of you avoiding criminal charges in health care investigations?

  • What is the percentage of you avoiding a license suspension or criminal liability in DEA opioid investigations?

  • Who at your firm will handle my case?


What Are Recent Case Outcomes Nick Achieved for His Clients in DEA/FBI Cases?



The natural tendency for people just to chat and to talk and to share their



  • United States v. Potash et al. (Pharmacy): Federal Judge DISMISSED the Entire Health Care Fraud Case Against Nick’s Client Although All Other Co-Defendants Had to Stay on the Case and Even Though Nick’s Client Was Considered the “Ringleader.”



  • DEA Search Warrant (Physician): DEA Alleged Violations of Controlled Substances Act. No Civil or Criminal Charges after Nick’s Intervention. No Reporting to Board.



  • DEA Search Warrant (Pharmacy): DEA Alleged Violations of Controlled Substances Act. No Civil or Criminal Charges after Nick’s Intervention. No Reporting to Pharmacy Board.



  • DEA Search Warrant (Pharmacy): DEA Alleged Violations of Controlled Substances Act. No Civil or Criminal Charges after Nick’s Intervention. No Reporting to Pharmacy Board.



  • DEA Overdose Investigation (Physician): Government Threatened Life Sentence. No Civil or Criminal Charges after Nick’s Intervention. No Reporting to Medical Board.



  • Federal Grand Jury Investigation (Physician): DEA and FBI Investigation Alleging Prescription Fraud. No Civil or Criminal Charges after Nick’s Intervention. No Reporting to Medical Board.



  • Federal Grand Jury Investigation (Physician): DEA Investigation Alleging Opioid Abuse, Medically Unnecessary Pain Prescriptions. No Civil or Criminal Charges after Nick’s Intervention. No Reporting to Medical Board.



  • Federal Grand Jury Investigation (Physician): DEA Investigation Alleging Controlled Substances Act Violations. No Civil or Criminal Charges after Nick’s Intervention. No Reporting to Medical Board.



  • Federal Grand Jury Investigation (Physician): FBI Investigation Alleging Kickbacks for Prescriptions. No Civil or Criminal Charges after Nick’s Intervention. No Reporting to Medical Board.



  • Federal Grand Jury Investigation (Business Owner): DOJ Investigation Alleging Kickbacks for Prescriptions. No Civil or Criminal Charges after Nick’s Intervention.



  • Federal Grand Jury Investigation (Health Care Business): DOJ Investigation Alleging Kickbacks for Prescriptions. No Civil or Criminal Charges after Nick’s Intervention.



  • Please ask Nick for many more examples. Call 866-Hire-Nick today!


Is My Consultation with Nick Oberheiden Confidential?



Yes, irrespective of your decision to later engage Nick Oberheiden and his team, Nick offers free consultations that are protected and confidential by law.

How Much Does It Cost to Defend My Case?



The answer to this question depends on the stage your case is in: is it a commercial insurance audit, a government subpoena, a search warrant, or a criminal indictment? Are you just weeks away from a federal criminal jury trial or do you just have preventive counseling and compliance questions? Attorney Nick Oberheiden is happy to speak with you about your specific concerns and to offer you a free and absolutely confidential consultation. If his track record and his unique approach convince you, Nick will work with you to tailor the legal representation to your current financial situation. Payment plans and credit card payments are available in some circumstances.

How Can I Speak to Nick Directly?



The easiest step in the entire process is to get in touch with Nick directly. When you call 866-Hire-Nick, you will be connected with Nick’s mobile device. Nick does not use secretaries and ALL clients will be represented by Nick and senior attorneys and never delegated to junior lawyers or paralegals.


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Do You Need Help with Your Case?

Are you under health care fraud or opioid investigation? Is your business under audit? Did you receive a notice from insurance companies or the government? Have investigators served you with a Civil Investigative Demand, a grand jury subpoena, an OIG subpoena, or did they try to interview you about a case? Did you experience a DEA or FBI search warrant? If you are seeking answers to pressing legal questions or are looking for effective and reliable help, then call DEA defense attorney Dr. Nick Oberheiden today. Nick will not hand your case to junior lawyers and no secretary will block you off. Call 866-Hire-Nick today, or contact him online, and get a free and confidential assessment from an experienced health care fraud defense attorney.

Legal Disclaimer

Nothing in this document is meant to be legal or medical advice. Prior results do not guarantee similar future outcomes. This document may constitute attorney advertising in some states. All disclaimers on Federal-Lawyer.com apply.

Who Will Handle Your Case

When you hire us, you will not work with paralegals or junior lawyers. Each lawyer in our Health Care Practice Group has handled at least one hundred (100) matters in the health care industry. So, when you call, you can expect a lawyer that immediately connects with your concerns and who brings in a wealth of experience and competence. For example, you need someone like Lynette S. Byrd, a former federal prosecutor in health care matters, who recently left the government and who is now sharing the valuable insights she gained as a health care prosecutor with our clients.

Bill C. McMurrey

Bill C.
McMURREY

Dr. Nick Oberheiden

Dr. Nick
OBERHEIDEN

Lynette S. Byrd

Lynette S.
BYRD

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