Ketamine Compliance Consultants & Attorneys
Put our former DEA agents and DOJ attorneys on your side.
Ketamine has exploded in popularity recently, thanks in large part to several small studies that indicated it could be used as an antidepressant and to treat psychiatric disorders, mental health disorders, and other behavioral issues like anxiety. However, the drug is still a controlled substance under state and federal laws. As a result, healthcare companies that want to tap into this market and provide what could become a very important form of mental health treatment need to be careful with their compliance mechanisms or risk exposing themselves to legal liability.
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KetamineCompliance Team
Former Supervisory Special Agent (DOJ)
The healthcare compliance lawyers at the national law firm Oberheiden P.C. have guided numerous healthcare companies and professionals through the legal requirements of this rapidly developing field.
Ketamine Therapy May Help Treat Mental Health Issues
Ketamine is a drug that has pain-relieving qualities and that can cause the loss of consciousness. It is typically used as an injectable form of anesthesia by medical professionals. However, it also has hallucinogenic properties that make it a popular drug to abuse recreationally – a serious issue because ketamine can be addictive.
Recently, however, studies have indicated that ketamine could also be used to treat mental health conditions, such as:
- Depression
- Anxiety
- Major depressive disorder
- Posttraumatic stress disorder (PTSD)
While these studies have been fairly small, by 2017 they proved to be enough to make the American Psychiatric Association (APA) release a statement with general instructions for mental health clinicians on how to use ketamine for these purposes. While the statement insisted that ketamine infusions should only be used to treat patients with mood and anxiety disorders who were previously resistant to other treatments, it was still a watershed moment for the acceptance of ketamine in the mental health field.
While the studies were enough to persuade the APA to accept ketamine as a potentially useful treatment for mental health issues, though, the U.S. Food and Drug Administration (FDA) was less willing to go along. Ketamine is not an FDA approved drug, and the FDA has only approved watered down versions of the drug, like Spravato, a compounded ketamine nasal spray, for use, and only then for treatment-resistant depression, and only then if it is administered in a restricted distribution system where the patient could be monitored by the provider. The FDA has gone so far as to issue a warning about the use of ketamine products to treat psychiatric disorders.
Put our highly experienced team on your side
Dr. Nick Oberheiden
Founder
Attorney-at-Law
Lynette S. Byrd
Former DOJ Trial Attorney
Partner
Brian J. Kuester
Former U.S. Attorney
Hon. Kevin McCarthy
55th Speaker, U.S. House of Representatives (ret.)
Government Consultant
Mike Pompeo
Of Counsel
Former U.S. Secretary of State
John W. Sellers
Former Senior DOJ Trial Attorney
Linda Julin McNamara
Federal Appeals Attorney
Nicholas B. Johnson
Former Prosecutor
Roger Bach
Former Special Agent (DOJ)
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Ray Yuen
Former Supervisory Special Agent (FBI)
New Off-Label Use Leads to Explosion in Popularity
Even with the FDA’s limitations, though, ketamine use for mental health and mood issues exploded in popularity in recent years. Ketamine clinics – where patients would receive a dose of ketamine, as ketamine infusion therapy, and then meditate on-site while they experienced the drug’s effects – popped up in cities large and small across the country. People suffering from depression and who have struggled to find a reliable treatment flocked to them. Some patients found that a single ketamine treatment was enough to make them feel better. Some others found that they needed regular treatments, often around every month or so. Still others found ketamine to be ineffective.
Nevertheless, and in spite of the fact that ketamine treatments are hardly ever covered by insurance and often cost over $400 per session, the industry has been estimated to be worth $3 billion, though there have been growing pains.
3 of the Most Important Potential Compliance Concerns
As with any novel approach to medicine that use potentially addictive substances, there are some serious compliance concerns facing the healthcare providers that have entered the ketamine market. The reality is that ketamine is still a controlled substance – a Schedule III drug, according to the U.S. Controlled Substances Act, that has medicinal use but also a moderate risk of abuse and addiction (21 U.S.C. § 812(b)(3)).
Healthcare providers and professionals that want to offer ketamine to patients with mental health issues should pause and seriously consider the following compliance issues that they may face.
1. Providing Ketamine is Practicing Medicine
Prescribing or administering ketamine is practicing medicine in the eyes of the law. This means that not everyone is allowed to do it. You will generally need to have a medical license to do it, establish a physician-patient relationship, or have the supervision of a physician in order to do it legally.
This is especially important if you are prescribing ketamine sessions through telemedicine. In the aftermath of the coronavirus pandemic, states are taking widely divergent paths in regulating telemedicine, so talking to a compliance attorney in your state is essential.
Additionally, the fact that ketamine sessions are a form of practicing medicine impacts ketamine infusion clinics operating in states that forbid the corporate practice of medicine. If this applies to you, you will need to structure the ownership of the ketamine clinic in a way that complies with the law.
2. Adequately Monitoring Patients Can Reduce Liability
The FDA approval of Spravato for treating mental health issues requires the patient to be monitored during the session. Ketamine is a hallucinogen, after all, and not all “trips” are good. Some are bad and traumatizing. Patient Safety- how closely the patient is monitored, and by whom, is a serious issue to consider.
Some ketamine clinics have focused on reducing costs by loosely monitoring ketamine users, and only then with someone who does not have adequate medical training on how to respond. Taking this approach at your clinic can jeopardize it if something goes wrong. If a patient has a bad trip and someone gets hurt, people will ask why more was not done, and why your ketamine clinic was so ill-prepared. Lawsuits will follow.
3. State Laws Still Forbid Kickbacks and Self-Referrals
Some healthcare providers see that ketamine treatments are not covered by a federal healthcare program, like Medicare. This can lead to the realization that the federal Stark Law and the Anti-Kickback Statute also do not apply to ketamine treatments.
While that is true, it does not mean that the state versions of these laws do not apply either. Many of these apply to healthcare, regardless of the payor. You can still be held liable for not complying with them.
Frequently Asked Questions About Ketamine Regulatory Compliance Issues and Oberheiden P.C.
What are the Penalties of Noncompliance?
It depends. Healthcare providers are expected to comply with a huge variety of federal and state laws, and even local laws. The penalties of noncompliance will depend on what laws were not satisfied and whether someone got hurt as a result.
For example, a physician who fails to comply with the dosing standards when administering ketamine to a patient could face a medical malpractice lawsuit if the patient gets hurt by the overdose. They may also be penalized with an action against their medical license. Meanwhile, ketamine providers who obtain the drug but who are not licensed to have it can face criminal charges of drug possession, possession with intent to sell, or drug trafficking.
Does My Ketamine Clinic Need to Be Licensed?
Because ketamine clinics are so novel and the treatment so new, states vary widely on what licenses are needed for them to open – or even whether they need to be licensed specifically for ketamine provision at all.
However, many of the clinics or facilities that open need to be licensed by the U.S. Drug Enforcement Administration (DEA) and carry a pharmacy permit to dispense and administer the drug. Some others have found it necessary or beneficial to get a permit to run an outpatient treatment center.
To figure out which licenses and permits you need – and which ones you do not necessarily need, but that could be wise to have – you should talk with a lawyer in your jurisdiction.
What Does it Mean to Be a National Law Firm?
Oberheiden P.C. is a national law firm. We are headquartered in Texas, but have satellite law offices in nearly every major American city. No matter where you are, we have an office close by that can provide the experienced compliance services that you need.
Why Should I Hire Oberheiden P.C. Rather Than Another Compliance Firm?
Numerous things set Oberheiden P.C. apart from other law firms.
Perhaps the biggest difference, though, is that we do not employ anyone on our legal staff other than senior attorneys.
When you hire other law firms, your case will be delegated to the legions of junior associates and paralegals that they have on hand. In many cases, the supervision that the senior lawyer – the one whose experience drew you to the firm and who is responsible for your case – is very light.
You do not get treated like that at Oberheiden P.C. All of the legal work on your compliance case will be conducted by senior-level lawyers who have numerous years of experience in protecting companies like your own from legal liability.
Why Doesn’t Oberheiden P.C. Call Itself the Best Healthcare Compliance Firm?
This is something that we prefer to let our prior clients say about our firm. Read their testimonials here.
Contact Oberheiden P.C.’s Ketamine Compliance Consultants & Attorneys for Help
Healthcare providers who want to offer ketamine services for patients with untreatable mental health issues need to tread carefully. While this field is still very niche, it is also very lucrative. But it is also very risky, with legal threats and the potential for liability coming from numerous different angles.
The best way to start offering ketamine services and sessions is to first discuss your business ideas with a skilled and experienced ketamine compliance attorney from your state. They will have a firm grasp of what you need to do in order to comply with the wide variety of state and federal laws that could apply to your venture, as well as how to comply with those requirements in ways that do not overburden your company.
Call the healthcare compliance consultants and lawyers at Oberheiden P.C. at (888) 680-1745 or contact them online.
