The DEA Defense Team

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YOUR DEA DEFENSE COUNSEL

Little Health Law’s team of experienced DEA defense attorneys protects physicians and medical practices in DEA matters nationwide. Our team includes former federal prosecutors, former federal Judicial Law Clerks, and career healthcare attorneys who specialize in defending physicians. We are devoted to protecting physicians and medical practices in high-stakes DEA matters.

Little Health Law is an AV-rated law firm dedicated exclusively to representing providers. Our legal team of health law attorneys is experienced in dealing with the United States Drug Enforcement Administration. In all of our firm’s legal engagements, we aspire to provide the highest level of customer service.

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DEA REGISTRATION PROTECTION

Physicians face many professional and regulatory risks that can derail a career or medical practice. Few regulatory risks are more daunting and potentially threatening than scrutiny and adverse regulatory action by the U.S. Drug Enforcement Administration (DEA) against a physician’s DEA registration. In virtually any physician or medical practice matter involving the DEA, much can go wrong quickly. The DEA does not typically show up to let you know that all is well—though, they may appear to be on your side at first.

“The DEA is here!  What do I do?”

  1. Our client is dealing with a very stressful situation, and 
  2. We Need to get involved as soon as possible to ensure our client knows their rights and does not sign anything without speaking with us first.  

We cannot stress that last part enough:
DO NOT SIGN ANYTHING THE DEA PRESENTS YOU WITH UNLESS YOU’VE DISCUSSED IT WITH YOUR HEALTHCARE COUNSEL BEFOREHAND.

A surprise visit from the DEA is rarely good news. More often, a DEA agent hopes to pressure the physician to do something that will have adverse consequences for the physician, such as voluntarily surrendering a registration or withdrawing an application. Therefore, it is imperative that the physician (or his staff) know what to do and not to do, if contacted by the DEA. Even an initial interaction with the DEA can be consequential. As a rule, it is recommended that when a DEA diversion agent makes contact with a physician (or physician’s medical office), the DEA agent be treated politely but immediately informed that the physician’s health care attorney is available to speak with him or her, as it is not typically advantageous to engage in any substantive discussions with the DEA except through a healthcare attorney experienced in DEA matters.

 

Be warned, DEA agents will, at first, often appear helpful and asking “routine” questions.  However, often the DEA Agent is employing tactics to gain as much information as possible before bringing adverse action against the registrant (or demanding a surrender of their DEA number).  The DEA is entitled to conduct administrative inspection of registrants and their facilities and records, however, there are procedural requirements and limitations to that authority.  As such, it is important that—before a physician or practice is faced with a visit by a DEA agent—the physician or practice has a procedure in place, which includes the process for responding to a DEA inspection, what to do if presented with a DEA Form 82 (which is used to notify individuals of an administrative inspection under the Controlled Substances Act), the registrant’s right to request a warrant before an inspection, and what information is excluded from inspections unless the registrant specifically consents to its inclusion (including Financial data, Sales data other than shipping data, and Pricing data).  21 U.S.C. § 880; 21 C.F.R. § 1316.01-.13.  Notwithstanding the preceding section, if the DEA pursues an adverse action on a physician’s registration, there may be some benefit to the physician being transparent with the DEA during its investigation, which further underlines the importance of having experienced counsel representing registrants with any DEA matters.

Our Health Law Team

Lee Hamil Little
health law attorney
Caitlin Lentz
health law attorney
Kevin S. Little

DEA DEFENSE MATTERS ARE HIGHLY UNIQUE AND REQUIRE UNIQUE EXPERIENCE

Rest assured, the DEA, as federal law enforcement, performs critical functions and services. The DEA’s intended role (in this context) is a good one and provides a measure of protection for the health care system. The regulatory power of the DEA is significant, and providers are wise to respect the rules and role of the DEA in carrying out its responsibilities.

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DEA REGISTRATION SURRENDERS

The DEA has authority under federal rules to accept a physician’s voluntary surrender of his/her license under 21 CFR § 1301.52(a). Section 1301.52(a) provides in part that “[i]n the case of a surrender, termination shall occur upon receipt by [the DEA] of a duly executed DEA form 104 or any signed writing indicating the desire to surrender a registration.”

“We just need you to sign right here.”

Those words should ring caution bells loudly in a meeting with a DEA diversion agent. In our experience, some DEA diversion agents have been willing to inappropriately push a physician to sign a Form 104 (for Voluntary Surrender of a Registration), with statements like, “It’s easy to reapply for a new registration,” or “This will take care of everything today,” or similar assurances without a clear discussion of the severely adverse professional and financial consequences that often attend signing the form. Many physicians, feeling pressure, wanting to do the “right thing,” or sensing (incorrectly) that they will be best off to be perceived as cooperating by signing what is presented to them, have made the mistake of signing a Form 104 Voluntary Surrender without the advice of counsel.  It is very rare in our experience that a physician who is successfully pressured by the DEA into signing a Form 104 knows and appreciates the full scope of adverse professional and financial consequences that likely will follow from that signature. Such consequences may include:

  1. Immediate loss of authority to prescribe or dispense certain controlled substances (schedules II-V);
  2. Mandatory reporting to the National Practitioner Data Bank (NPDB);
  3. Mandatory reporting to state medical licensing boards;
  4. Mandatory reporting to CMS;
  5. Employment termination (where the employment terms require a DEA registration); 
  6. Loss of hospital privileges; 
  7. Difficulty obtaining reinstatement of the registration or a new registration;
  8. Removal from commercial payor networks; and
  9. Adverse legal admissions (language contained in the form, such as “alleged failure to comply” or “remedy . . . . unlawful practices”).

On the other hand, there is typically little to gain by signing a Form 104 Voluntary Surrender, other than the (false) perception that the DEA agent will be placated and the situation will be fully resolved. In reality, even following a surrender, the DEA will continue its investigation, so even the investigation itself does not end upon surrender. For these reasons, a physician should consult with a DEA defense health law attorney if presented with a Form 104 for signature.

APPLYING FOR A NEW LICENSE AFTER A SURRENDER

If a physician surrenders their registration, it is difficult to gain a new DEA number. That said, there are strategic ways to submit a new application, including timing the submission in an advantageous way and bolstering the application to offset prior DEA concerns.

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DEA AUDITS AND INVESTIGATIONS

A principal purpose of the DEA is to ensure compliance with the Controlled Substances Act (“CSA”), 21 U.S.C. § 801, et seq. The CSA categorizes regulated substances into five schedules according to medical use, safety and other relevant factors articulated in the CSA. The CSA lists those factors in Section 201(c), [21 U.S.C. § 811(c)], as follows:

  1. An actual or relative potential for abuse.
  2. Scientific evidence of its pharmacological effect.
  3. The state of current scientific knowledge regarding the substance.
  4. History and current pattern of abuse.
  5. Scope, duration, and significance of abuse.
  6. What, if any, risk there is to the public health.
  7. Its psychic or physiological dependence liability.
  8. Whether the substance is an immediate precursor of a substance already controlled under this subchapter.

One way the DEA seeks to enforce compliance with the DEA is by identifying problems through audits.  The DEA has authority under the CSA to conduct audits, which are also referred to as “administrative inspections.” A “Form 82” Notice of Inspection is issued pursuant to the DEA’s authority under 21 CFR § 1316 These audits can be comprehensive and include scrutiny of patient records, inventory records, invoice paperwork, other record-keeping information and security measures. The DEA’s authority does not permit the DEA to inspect financial data, sales data, or pricing data.

To initiate an audit the DEA will typically issue a Notice of Inspection. The Notice of Inspection is required to include:
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  1. The name and title of the owner, operator, or agent in charge of the controlled premises;
  2. The controlled premises name;
  3. The address of the controlled premises to be inspected;
  4. The date and time of the inspection;
  5. A statement that a notice of inspection is given pursuant to section 510 of the Act (21 U.S.C. 880);
  6. A reproduction of the pertinent parts of section 510 of the Act; and
  7. The signature of the inspector.
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To conduct an administrative inspection, the agent typically needs a warrant, but there are a number of exceptions to that requirement, including when an establishment is applying for initial registration; with the consent of the owner, operator, or agent in charge of the controlled premises; and in situations presenting imminent danger to health or safety.  21 U.S.C. § 880; 21 C.F.R. § 1316.07.

Another tool the DEA can use is an administrative subpoena. 21 U.S.C. § 876.  The DEA can use an administrative subpoena to “subpoena witnesses, compel the attendance and testimony of witnesses, and require the production of any records” that are “material to the investigation.”

Adverse outcomes of DEA audits and investigations can include civil fines, the risk of losing a DEA registration, and/or criminal liability.  In fact, DEA matters can include up to three parallel proceedings at one time:

  • regulatory action by the DEA;
  • civil action by the U.S. Department of Justice (“DOJ”) (prosecuted by U.S. Attorneys); and 
  • criminal action by the DOJ (prosecuted by U.S. Attorneys).

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DEA REGULATORY ACTION: ORDER TO SHOW CAUSE; IMMEDIATE SUSPENSION ORDER

If the DEA believes a registrant’s continued registration is “inconsistent with the public interest” (defined in 21 U.S.C. § 823(g)(1)), then the DEA may move to revoke the registrant’s DEA Certificate of Registration (“COR”) by issuing an Order to Show Cause.  21 U.S.C. 824.
The Order to Show Cause will essentially summarize why the DEA is taking the action and provide notice about the registrant’s right to provide an answer, request a hearing, and to submit a corrective action plan.  Common reasons cited in Orders to Show Cause include improper prescribing, poor record-keeping, failure to properly follow the two-factor authentication procedure for signing e-prescriptions, or, if a physician’s state license is suspended or revoked.  In addition to finding the continued registration inconsistent with the public interest, the DEA may revoke or deny a COR if the DEA finds that the registrant:

  1. Once a physician receives an Order to Show Cause, the physician must respond within 30 days by filing an answer and request for a hearing. If the physician fails to respond, the action will proceed uncontested. Materially falsified the application.
  2. Has been convicted of a felony under the CSA or any other law of the United States, or of any state, relating to a controlled substance or a list I chemical.
  3. Had a state license or registration suspended, revoked, or denied by a competent state authority and is no longer authorized by state law to engage in the manufacturing, distribution, or dispensing of controlled substances or list I chemicals, or has had a suspension, revocation, or denial of a registration recommended by competent state authority.
  4. Has been excluded (or directed to be excluded) from participation in a Medicare or state health care program.

In addition to an Order to Show Cause, when the DEA believes that there is “imminent danger to the public health or safety,” the DEA can issue an Immediate Suspension Order.  21 U.S.C. 824(d) (Imminent danger to the public health or safety “means that, due to the failure of the registrant to maintain effective controls against diversion or otherwise comply with the obligations of a registrant under this subchapter or subchapter II, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration”).  Whereas it may take many months to resolve an Order to Show Cause, during which the registrant can continue operating under their DEA number, if an Immediate Suspension Order is issued, the registrant’s DEA number is immediately suspended.

DEPARTMENT OF JUSTICE CIVIL AND CRIMINAL ACTIONS

In addition to action taken by the DEA against a Registration, the Department of Justice, through its U.S. Attorneys, may initiate civil and/or criminal actions. A U.S. Attorney can initiate a civil or criminal action by filing a federal lawsuit against the registrant. Under civil actions, the government will seek civil monetary penalties. 21 C.F.R 842(c); 28 C.F.R. 85.5. Under the CSA, the civil penalty is issued per violation, and the current penalty is $80,850 per violation. If the registrant issued unlawful prescriptions, for instance, then each prescription is a penalty potentially incurring a civil monetary penalty of $80,850—the penalties can add up to millions very fast.

In cases where the conduct reaches the level of criminal conduct, the U.S. Attorney’s office may initiate criminal proceedings. Often times, the criminal proceedings run parallel to both the DEA’s regulatory proceeding and the DOJ’s civil proceeding.

WE DEFEND DEA REGISTRANTS

Little Health Law’s team of experienced DEA defense attorneys protects physicians and medical practices in DEA matters nationwide. Our team includes former federal prosecutors, former federal Judicial Law Clerks, and career healthcare attorneys who specialize in defending physicians. We are devoted to protecting physicians and medical practices in high-stakes DEA matters. Martindale Hubbell has awarded our firm its AV-rating, the highest possible rating. Our law firm maintains offices in Atlanta and Augusta, Georgia. Call us at 404-685-1662 (Atlanta) or 706-722-7886 (Augusta) to schedule a confidential consultation.

DISCLAIMER: Any result this law firm or any lawyer of this law firm may achieve on behalf of one client in one matter does not necessarily indicate similar results can be obtained for other clients.