Reasons To Have Legal Advice on DEA Registration
DEA registration defense is a mind-boggling legal minefield. Retaining an expert DEA defense lawyer is vital for physicians and pharmacists with a license to dispense highly regulated drugs, while strictly adhering to the guidelines of the Controlled Substances Act. CSA.
The inability to adhere to these guidelines can initiate a DEA legal action resulting in criminal, civil, and administrative sanctions. Non-expert legal representation during these proceedings can be disastrous and might lead to loss of registration, assets, business, licenses, and possible jail time.
Who is a Target?
DEA enforces compliance with CSA through periodic audits of physicians and pharmacies. Being the target of an audit means that the DEA has information about your activities, and the DEA prescription drug monitoring program has recommended an administrative inspection of your practice or drugstore.
Who Can Revoke My Registration?
DEA investigators cannot unilaterally revoke your registration during a DEA audit, or investigation, or by pressuring you to sign DEA Form 104. This can only happen after a lengthy procedure involving attorney representation, negotiations, and a court process culminating in a judge ruling which can be appealed to a Federal court.
Steps To Take During A DEA Investigation
Communicate Through Your Counsel
Experienced dea defense lawyers understand the inner workings of the DEA well enough to build a solid line of communication with DEA officials ensuring effective correspondence and feedback.
Your lawyer must handle all communications, and ensure all submitted documents are error-free to prevent future misunderstandings with the DEA.
Evaluate your practice
At Spodek Law Group , we understand the need for our clients to undertake self-assessment. And we help them prevent future DEA investigations by performing two key functions;
We defend clients by assuring the DEA that they are in compliance with CSA guidelines, and
We rectify any recurring issues ensuring clients develop processes that do not violate CSA regulations in the future.
How To Avoid DEA Attention.
The DEA initiates investigations based on data accrued from the prescription activities of medical practices and pharmacies. You can also develop an assessment process known as DEA Corrective Action Plan based on data obtained from your practice prescription activities to remain in compliance with DEA regulations.
What Is a Corrective Action Plan?
According to U.S.C. 824 (C) (2) (C), the DEA must evaluate a corrective action plan submitted by your lawyer before taking administrative action against your business.
A corrective action plan gives you a greater advantage when arguing your case before the DEA. It is proof indicating your intention to comply with DEA regulations, and in the event, administrative action has been taken; to convince the DEA administrator to retain your registration.
Vigorously Defend Allegations
Defend false allegations of violations of DEA regulations by developing an investigation plan providing irrefutable proof of your innocence at the DEA hearing, or a civil or criminal trial.
Prescription related cases require your lawyer to launch a thorough review of your practice, providing evidence showing your prescriptions are legally approved for use as required in medical professional practice
In dispensing related cases, dispensing records must be reviewed, and any documented issues linked with past prescriptions must be unearthed to use as proof of innocence. When armed with evidence supporting your innocence, be forceful in your defense in order to win an acquittal.
Important DEA Regulations
Security Requirements, 21 CFR 1301.71(a) and (b)
Suspicious Order Monitoring, 21 CFR 1301.74(b)
Theft and Loss, 21 CFR 1301.74(c)
Medical Necessity, 21 CFR 1306.04
Issuance of Prescriptions, 21 CFR 1306.05
Corresponding Responsibility, 21 CFR 1306.04(a)
Refilling of Prescriptions, 21 CFR 1306.22
Your Team for DEA Compliance and DEA Audit Defense
Spodek Law Group represent client interests during DEA actions against their practices such as; DEA raids, investigations, and audits. We handle your DEA registration applications and denials, defend your DEA registration suspension and revocation.
Spodek Law Group dea defense lawyers consult with clients on compliance with government regulations regarding highly regulated drugs. In the event of a client violation of the CSA, we create a line of communication with the DEA. And work on securing an agreement from both our client and the DEA, with the aim of resolving the case on terms favorable to the client.
In recent years, multiple agencies have cracked down on health care providers that exist for the purpose of writing and filling prescriptions for controlled substances. Disciplinary action taken against pain management physicians and clinics has been swift and severe. This includes pharmacies used to fill prescriptions written under the same premise.
Discipline typically involves shutting down the facility and arresting those involved, including physicians and staff. There are even some instances where patients have been arrested. The charges for the offenses associated with dea-criminal-lawyers/”>DEA registration disciplinary action generally relates to various criminal offences. The legal proceedings can be either state or federal, depending on the circumstances.
The reason why so many facilities are shut down during the same timeframe is because the multiple agencies involved often form a taskforce that conducts raids in a particular area. There are some instances in which search and seizure raids are disguised as city inspections. Agencies involved may include the local police department, the Drug Enforcement Administration, the Department of Health and the Attorney General’s Office, among others.
By the time there are search and seizure raids, it’s likely that an dea/defense-lawyers/dea-audits-and-dea-investigations-dea-lawyers/”>investigation has taken place in advance and was performed by either the DEA or the state licensing authority. There’s a possibility that both entities will get involved.
The reason why an investigation usually takes place is because complaints have been lodged. Sometimes complaints are made by people in the community, but they might also be made by pharmaceutical manufacturers, family members of patients or even competitors. The source of complaints are often wide-ranging.
It’s important to understand that pharmaceutical manufacturers track the narcotics they sell, which means they have information regarding the buyer and the quantities sold for each purchase. This is especially true when it comes to the sale of certain medications and narcotics, such as Xanax, Hydrocodone, Oxycodone, Roxycodone and Percocet. Sometimes a physician, clinic or pharmacy is reported because they placed an order that was much larger than any amount that would be considered standard or customary.
When a raid takes place or similar events occur, it can result in the dea/defense-lawyers/dea-registration-suspension-revocation/”>suspension of DEA registrations. Suspension of a dea registration number means controlled substances and narcotics are no longer allowed on the premises. Subsequently, the dea/defense-lawyers/dea-registration-surrenders-2/”>DEA will seize everything not permitted without a DEA registration. There’s also a good chance that a cease and desist order will be issued. This is in addition to the multiple arrests that will likely take place as aforementioned. There have been some instances where the custody of controlled substances was given to another licensee with a dea registration number.
In many cases, a large quantity of medications with a high dollar value are seized by the dea because there was no other DEA-licensed contact available to take possession of the medications after a raid. When these events happen, it’s imperative that you contact a criminal defense attorney immediately. In fact, you should request that your attorney arrive on site as soon as possible, preferable before you have any conversations with agents or investigators. What happens during and directly following a raid is critical and can have lifelong and devastating consequences.
dea agents, investigators from the Department of Health, and possibility other parties involved will likely request that you voluntarily relinquish your dea registration and number. This is just one example of why it’s important to have legal counsel onsite immediately. Voluntarily giving up your dea/defense-lawyers/dea-registration-surrenders/”>DEA registration and number is something that should not happen. There is a lot at stake and you’ll want to make sure you have qualified legal representation available to guide you through the process.
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Although dea audits are routine procedures, they often result in criminal prosecution. In addition, if you violate the Controlled Substances Act, you are likely to face administrative measures against your dea registration. It is therefore advisable for dea registrants facing a DEA audit or investigation to consult a lawyer.
The dea-audit-and-investigation-lawyers/”>DEA conducts audits and investigations to ensure the parties in question comply with the Controlled Substances Act (CSA). There are various reasons for conducting dea-audit-lawyer/”>DEA audits and investigations. These include:
Generally, dea/defense-lawyers/nyc-dea-audits-investigations-lawyers/”>DEA audits occur once after three years, however, it is frequent for practitioners who prescribe buprenorphine or who have a Drug Addiction Treatment Act of 2000 waiver. Narcotic distributors, treatment programs, and other unlicensed dea/defense-lawyers/dea-registration-suspensions-and-revocations/”>DEA registrants face inspection once after five years.
dea Notices of Inspection (dea Form 82) and Warrants
The dea does not need a warrant to carry out an inspection to check for CSA compliance. However, when the dea-investigation-lawyers/”>DEA is conducting an investigation in conjunction with other authorities, a search warrant is important for searching a clinic/practice. dea investigators conduct inspections in various state offices in the U.S. and are affiliated with the dea‘s Diversion Control Program. The first step in a dea-audit-lawyer/”>DEA audit is a notice of inspection or the issuance of a dea Form 82 or an inspection warrant to the person under investigation. At this point, the presence of a lawyer is important for the interpretation or the determination of the legality of the warrant.
Informed Consent for dea-audit-lawyer/”>DEA Audits
After the administration warrant is issued, the registrant should give their consent before an inspection or audit commences. An informed consent refers to a statement in writing indicating that the registrant is aware of their constitutional right to turn down an inspection and that any incriminating evidence can be used during a criminal prosecution, and that they offer their voluntary consent.
There are cases when the dea does not require informed consent or a search warrant for a DEA inspection. A warrant is not required for inspecting records and books in accordance with a subpoena presented by the dea/defense-lawyers/dea-registration-surrenders/”>DEA, or for inspections that are conducted because there is imminent danger to public safety, or for determining dea registration.
Administrative Inspection and Search Warrants
In case a dea/defense-lawyers/dea-audits-and-dea-investigations-dea-lawyers/”>DEA registrant fails to offer informed consent to an audit, the dea should get an administrative inspection warrant from the Federal District Court. The dea/defense-lawyers/preparing-for-a-dea-inspection/”>DEA is not required to prove probable cause for inspection warrants. To obtain a search warrant, the dea should describe the extent and nature of the inspection and the items they intend to seize.
dea registrants are required to comply with administrative search warrants. When a registrant fails to comply with the warrant, they are likely to face jail time. It is advisable to contact an attorney the moment you receive a search warrant for advice on what to do, and for guidelines on how to protect your dea/defense-lawyers/dea-registration-surrenders/”>DEA registration.
There are various reasons a registrant may refuse to consent to an inspection. First, dea/defense-lawyers/dea-registration-application-denial/”>DEA audits are conducted without warning and the registrant may need to contact a lawyer before the search begins. When a dea/defense-lawyers/dea-registration-surrenders/”>registrant receives a DEA Form 82, they should call their lawyers to determine whether they should give informed consent for inspection. If the dea-investigation-lawyers/”>DEA issue an administrative search warrant while the investigations are underway, the presence of legal counsel during the process will ensure the dea conduct their search within the limits of the warrant. Furthermore, legal assistance will help you identify crucial areas that can help your practice look favorable to the dea.
Scope of dea/defense-lawyers/nyc-dea-audits-investigations-lawyers/”>DEA Investigations
The dea does not have the authority to inspect everything in your practice. The dea is authorized to interview you and your employees. Anything you or your staff admits to during the interview will be used against you in a criminal proceeding. Therefore, you need to have a lawyer by your side before any interview to prevent incrimination and ensure your rights are protected.
There is an increasing number of suspension orders served by the Drug Enforcement Administration (DEA) that have resulted in the suspension of DEA registrations. There have also been a variety of related orders issued, such as orders to show cause as to why a DEA registration shouldn’t be revoked. This has been born out of criminal charges against health care organizations across the United States. These incidents have resulted in the arrest of doctors, staff and sometimes patients after pain management clinics and even some pharmacies were shut down.
Task forces have been developed in coordination with multiple agencies that often include the dea, the police department and the Attorney General’s Office for the state where the health care facility is located. A multi-agency task force will usually conduct what they call inspections or site visits that result in arrests after search and seizure.
There are a list of often abused over the counter medications and prescriptions that are tracked by pharmaceutical companies, including manufacturers and distributors. Some of the medications of particular interest and concern by the dea include Xanax, oxycodone, Percocet and hydrocodone, to name a few. In the event that orders placed for medications are much larger than what’s usual, there’s a good chance that the manufacturer will dea/defense-lawyers/dea-drug-diversion-reporting/”>report the purchaser to the DEA, whether it’s a pharmacy or physician.
There are a variety of other reasons why a raid might take place, but it’s most often because a series of complaints have been made. Enough complaints can eventually result in search and seizure, but that usually only happens when an investigation has been in the works for a significant amount of time. In addition to notices received from pharmaceutical manufacturers, sometimes local law enforcement agencies, businesses in the area and even family members will file a complaint with the dea if they believe something untoward is occurring.
As previously mentioned, there’s a distinct possibility that dea/defense-lawyers/dea-registration-suspensions-and-revocations/”>DEA registration will be suspended and revoked if the doctor and staff are arrested. The same applies to the arrest of a pharmacist. The timeframe in which the suspension or revocation takes places will vary. That decision is something that often determined in advance as the priority is executing the arrest warrants.
If your dea/defense-lawyers/dea-registration-surrenders/”>DEA registration number is suspended, medications in the facility will be automatically seized by the dea and removed from the premises. In the event of a raid, it’s not uncommon for a significant amount of money to be loss. The only way it won’t happen is if there is another person that’s licensed and can acquire custody of the medications. This isn’t usually an option that’s considered in the midst of a raid.
If you are arrested due to a raid, it’s important to contact your criminal defense attorney for immediate consultation given the seriousness of the situation. They will guide you through critical legal aspects of the situation that have the potential to impact you during administrative and criminal proceedings in the future. They can also assist you with managing the issue of your dea registration.
You will likely be asked by more than one entity within the task force to voluntarily relinquish your dea registration, which is not something that you should even consider. Even if you’re told that you can apply for a new dea/defense-lawyers/dea-registration-application-denial/”>DEA registration later, do not give up your current registration. Keep in mind that anytime you relinquish a pharmacy or medical license as a result of an arrest or a related matter, there is very little chance of you receiving another one in the future.
Our firm is dedicated to helping protect DEA registrations of practicioners, facilities, pharmacists, distributors, and all other DEA registrants. On a regular basis, our law firm handles clients with things such as:
-DEA registration revocation issues
-Denial of dea registratoin
-DEA inspections and audits
-falsifying dea/defense-lawyers/dea-registration-surrenders/”>DEA registration application
-state license suspended, revoked, denied
-registrant is excluded from participating in medicare or medicaid programs
-registrant was convicted of a felony relating to controlled substance
-registrant acted in a manner inconsistent with the public interest
When the dea/defense-lawyers/dea-registration-disciplinary-action/”>DEA takes an action to suspend or revoke registration, they have to serve an order to show cause on the registrant. In certain emergency situations, the dea/defense-lawyers/dea-order-to-show-cause-representation/”>DEA may find imminent danger to the public health – and suspend a DEA registration with the issuance of a immediate suspension order and show to cause. This order forces you to show why your dea/defense-lawyers/dea-registration-surrenders/”>DEA registration should NOT be revoked, or denied. The order will typically contain a legal basis/reason for issuing the order, and will have a summary of the facts and the law written on it. Like actions taken by the state medical boards, the dea/defense-lawyers/dea-registration-surrenders/”>DEA registrant has the legal right to request a hearing with an administrative law judge in order to challenge the facts alleged in the order to show cause. You have 30 days from the date the order is served to file a request for a hearing. Failure to file within the 30 days will be considered a waiver of your rights to a hearing. As a result, the dea may request a final action be taken. It’s crucial you hire a dea/defense-lawyers/dea-registration-suspension-revocation/”>DEA registration suspension lawyer to help. We can help preserve your rights and prepare a defense to protect your registration.
Show cause hearings are done before a federal judge. Each party presents their arguments. You can submit evidence, and witnesses, in order to provide evidence for your case. In these proceedings, the dea has the burden of proof to show evidence that a violation occurred. The administrative hearing will determine whether your dea/defense-lawyers/dea-registration-suspension-revocation/”>DEA registration is in the interest of the public, or not. Following the hearing, the ALJ will usse a recommendation which is submitted to the dea administrator. If the registrant, or the dea, disagree’s with the ALJ’s recommended decision – they can submit an exception. The dea administrator will typically issue a final decision when it comes to adopting, modifying, or rejecting the decision.
The dea/defense-lawyers/dea-registration-suspension-revocation/”>DEA considers the following factors when determining a DEA registration should be suspended
1. The registrant failed to maintain effective controls to prevent diversion of controlled substances.
2. The registrant failed to comply with state and local laws
3. There was prior federal or state convictions relating to the manufacture/distribution/dispensing of controlled substances
4. The registrant has no experience when distributing controlled substances
If you’re unsatisfied with the final decision you can appeal the decision to the U.S. Court of appeals.
The dea/defense-lawyers/dea-registration-surrenders/”>DEA frequently contacts registrants before taking any actions. The dea/defense-lawyers/dea-order-to-show-cause-representation/”>DEA will try to get you to voluntarily relinquish your registration in order to avoid further action. Often, registrants voluntarily relinquish it because of fear of criminal action. Many do so, without legal counsel. Theres a number of reasons why you shouldn’t dea/defense-lawyers/dea-registration-surrenders-2/”>surrender your DEA registration.
-You will not be able to get registration in the future
-You may face state licensing action because you surrendered your registration
-You may be excluded from medicare and medicaid
-You may be reported to the board and suffer job loss
-DEA registration surrenders are reported to the National Practitioner Databank
Our DEA Registration Suspensions Lawyers practice full-time, helping prescribers and dispensers protect their dea registration and state licenses. Our DEA Registration Suspensions attorneys are well experienced in helping practitioners defend their registration – both in court, and in addition helping them protect it during dea registrations, dea registration denials, and renewal issues. Our DEA Registration lawyers are passionate about helping medical professionals protect their licenses and careers. Please contact us immediately if you have any questions.
If ever the question is asked about whether you should surrender your DEA registration, always remember that the answer is emphatically no. This is the only answer. What usually happens is a DEA agent shows up at your practice and starts to ask questions about how you prescribe medication. While some might think it’s a routine inspection, there’s a good chance that it’s anything but routine. Generally speaking, by the time a dea agent arrives at your practice, there has already been an investigation in the works for a good period of time.
At some point during the discussion with the dea agent, you’ll probably start to worry about what’s going to happen next. Most practitioners respond to the questions asked by the agent because they feel duty bound to comply. The fear and worry that’s inherent when communicating with a dea agent is why many just do whatever is asked of them.
During the interview, the conversation will likely turn towards voluntarily dea/defense-lawyers/dea-registration-surrenders/”>surrendering your DEA registration. This will include information about why it’s in your best interest to do so. The agent will encourage you to voluntarily surrender your dea/defense-lawyers/dea-registration-suspensions-and-revocations/”>DEA registration because it will be revoked anyway. What usually follows is a form for you to sign. It’s a voluntary surrender form awaiting your signature. If you haven’t already picked up the phone to call your lawyer, you should definitely do so before signing anything, especially a voluntary surrender form.
The dea/defense-lawyers/dea-registration-disciplinary-action/” >DEA agent might also tell you that you’ll be able to reapply for a DEA registration when everything has been resolved. Unfortunately, once you voluntarily surrender your registration under such circumstances, you probably won’t get it back or obtain another one. It’s common for practitioners to sign the form out of fear, which arises because the agent has spoken about the amount of trouble they’re in. The practitioner’s goal is usually to mitigate the problem by doing whatever is asked of them.
If you sign the form, an inspection and raid will be the last of your worries because you will have just ended your career. It’s a decision that can have a devastating affect on your entire life. Some practitioners have said it’s the worse decision they could have ever made. What has just happened is a practitioner has received legal advice from a dea agent that does not have their best interest in mind. To some degree, the decision was made under duress. Even if that’s the case, the form is still binding.
The problems that can arise as a result of a dea/defense-lawyers/dea-registration-suspension-revocation/”>DEA registration surrender is why it’s important to consult with legal counsel. In fact, you should request that your attorney show up at your practice immediately. If ever there was an emergency situation when you needed an attorney, this is it.
Beyond the fact that you probably will not be able to apply for a dea registration again, there are other reasons why you should not surrender it. One significant reason is that surrendering your dea registration might end up triggering other actions against you, such as actions that would affect your state pharmacy or medical license. It could impact any other professional license that you’ve earned.
The reality is that the Attorney General will need to prove a few things before they are able to either revoke or suspend your dea/defense-lawyers/dea-registration-application-denial/”>DEA registration. For example, they will have to prove that you committed an act that was not in the best interest of the public. The very best thing you can do when a dea/defense-lawyers/dea-defense-attorney__trashed/” >DEA agent arrives at your front door is contact an attorney right away.
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If you’re facing a DEA investigation, one of the options you may have is surrendering your DEA registration. Often, DEA agents do investigations and will routinely recommend the healthcare provider voluntarily surrender his/her DEA registration. During the course of an investigation, you may be given a voluntary surrender form, and request to surrender it. Often, providers are scared and fear the consequences of a raid by the dea, and sign away their careers easily and quickly. Regardless of how severe the magnitude of the investigation is, this is the worst thing you can possibly do. We recommend never listening to a dea agent. What you should do is hire an attorney who can advise you about dea/defense-lawyers/dea-registration-surrenders-2/” >DEA Registration Surrenders.
The dea/defense-lawyers/dea-registration-suspensions-and-revocations/” >DEA adjudication process has significant delays which can benefit you, by allowing you to practice while you resolve your dea registration issue. If you surrender your dea license, it can trigger an administrative action against other professional licenses you have – like your medical or pharmacy license. When you surrender your dea/defense-lawyers/dea-registration-suspensions-and-revocations/” >DEA registration willingly – it can hinder your chances of reapplying for a DEA registration later.
There are some circumstances under which the dea/defense-lawyers/dea-registration-suspension-revocation/” >DEA can revoke or suspend your DEA registration.
Before revoking your dea/defense-lawyers/dea-registration-suspension-revocation/” >DEA registration, the Attorney General has to provide you with an Order To Show Cause, discussing why your registration should be denied or suspended. You have to respond within 30 days of the order, otherwise administrative proceedings will commence. In certain urgent situations, the AG will suspend a registration when there is imminent danger to the public. If you refuse to voluntarily surrender your dea/defense-lawyers/dea-registration-suspensions-and-revocations/” >DEA registration, then the dea will have to submit an order to show cause and they will have to prove you with an opportunity to defend yourself in a hearing. If you do surrender your dea/defense-lawyers/dea-registration-suspensions-and-revocations/” >DEA registration, then you’re waiving your right to a hearing. After a criminal, civil, or administrative proceeding happens – you will be required to re-apply for your registration.
Laws governing the prescription of controlled substances are different in each and every state. When a healthcare provider voluntarily surrender his/her dea/defense-lawyers/dea-registration-suspensions-and-revocations/” >DEA registration, there is a chance the state can take independent actions to either revoke, limit, or suspend, your state license. Unfortunately, there is a domino effect when an administrative action (including a voluntary surrender) is taken by the dea. This voluntary surrender of your dea/defense-lawyers/dea-registration-suspensions-and-revocations/” >DEA registration can result in both legal expenses, state licenses suspended, and even state actions.
Refusing to voluntarily surrender your registration can delay this domino effect and prevent it. In addition, many hospitals and institutional bodies and insurers, require a dea license as a condition of employment. Voluntary surrender of your dea/defense-lawyers/dea-drug-diversion-reporting/”>DEA registration can trigger a mandatory reporting requirement to your credentialing body. This can lead to a harsh action against you, and loss of privileges.
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