How to Start a Ketamine Clinic (and Add TMS): 2026 Guide to Costs, Licensing and Staffing

Last updated: October 23, 2026 · Written for clinic owners, medical directors and practice administrators

To start a ketamine clinic, you need five things in place: the right business structure, a state license and DEA registration for each location, a safe and well-equipped treatment space, written clinical protocols, and a trained team. If you also plan to offer Spravato (esketamine) or TMS, add REMS certification for Spravato and an FDA-cleared device and payer approvals for TMS. Most new owners spend several months on these steps before the first patient visit.

This guide explains how to start a ketamine clinic step by step. It also covers how to add TMS, what it costs to open, which billing codes apply, and how to staff the clinic. Please note that this is a business and compliance guide. It does not give medical advice or make treatment claims.

Ketamine, Spravato or TMS? Choosing Your Service Model

Before you sign a lease, decide which services you will offer. Each one has a different regulator, billing route and staffing need. As a result, your choice shapes almost every later step.

IV ketamine

Ketamine is a Schedule III controlled substance. The FDA has approved it only as an anesthetic, so its psychiatric use is off-label. In addition, the FDA has warned that compounded ketamine products have not been reviewed for safety or quality. Most clinics offer IV ketamine as a cash-pay service, because insurers rarely cover it for psychiatric use.

Spravato (esketamine)

Spravato is an FDA-approved nasal spray for certain adult depression indications. However, it is only available through a Risk Evaluation and Mitigation Strategy (REMS). The clinic must be certified, patients must be enrolled, and staff must monitor each patient for at least two hours after each dose. Many commercial payers and Medicare cover it, so billing is more complex than for cash-pay ketamine.

TMS (transcranial magnetic stimulation)

TMS uses an FDA-cleared medical device. The FDA first permitted TMS marketing for major depression in 2008 and later cleared certain devices for other uses, such as OCD in 2018. TMS is usually billed to insurance. However, payers generally require prior authorization and a psychiatrist’s order and supervision.

Factor	IV ketamine	Spravato	TMS
Main regulator	DEA (Schedule III), state boards	FDA REMS, DEA (Schedule III)	FDA device clearance, payer policies
Upfront cost	Lower: pumps, monitors, emergency equipment	Lower to moderate: monitoring space, drug inventory	Higher: the device itself
How it is paid	Mostly cash-pay	Commercial insurance and Medicare, often buy-and-bill	Commercial insurance and Medicare, with prior authorization
Key staff	Medical director, prescriber, RN, ACLS-trained staff	Prescriber, RN or medical assistant for monitoring, REMS lead	Psychiatrist (orders and supervises), TMS technician
Space	Private infusion rooms with monitoring	Observation rooms for 2+ hours per visit	Treatment room with a suitable electrical supply
Typical ramp-up	Slow, driven by marketing and referrals	Depends on payer approvals and REMS setup	Depends on prior authorizations and referrals

Choose a practice model

Next, choose how the clinic fits into your business. There are four common models:

• Standalone clinic. A dedicated ketamine or interventional psychiatry clinic. This gives full control, but you must build referrals from scratch.
• Add-on to a psychiatry practice. You add ketamine, Spravato or TMS to an existing practice. Because you already have patients and staff, this is often the lowest-risk route.
• Anesthesia- or pain-led clinic. An anesthesia or pain group adds ketamine services. In this model, you will still need psychiatric evaluation and follow-up.
• Multi-site group. Several clinics share a medical director, billing team and protocols. Each site still needs its own DEA registration.

How to Start a Ketamine Clinic in 11 Steps

1. Form your business and check ownership rules

First, set up a legal entity and get an Employer Identification Number (EIN). Then check your state’s corporate practice of medicine (CPOM) rules. Some states do not allow non-physicians to own a medical practice. In those states, owners often use a management services organization (MSO) that works with a physician-owned professional corporation. A healthcare attorney in your state can confirm the right structure.

2. Get state licenses and confirm who may give IV ketamine

Next, confirm what your state requires. Rules differ on clinic licenses, who may give IV ketamine, and what monitoring and emergency equipment are needed. For example, Utah’s SB 197 (2023) sets rules for outpatient non-anesthetic ketamine. They include written and verbal consent, ACLS or PALS training, a crash cart, standard monitors and capnography. Check with your state boards of medicine, nursing and pharmacy before you hire. Also confirm the scope of practice for CRNAs and nurse practitioners in your state.

3. Register with the DEA for each location

Because ketamine is a Schedule III drug, each location that stores or gives it needs a DEA registration. Under 21 CFR 1301.12, a separate registration is generally required for each principal place of business. You usually need your state license and the clinic’s address before you apply. Also plan for secure storage, dispensing logs, inventory records and loss reporting.

4. Enroll in the Spravato REMS (if you offer it)

If you plan to offer Spravato, the clinic must become REMS-certified. In addition, each patient must be enrolled, and every dose must be given under direct observation. The FDA-approved Spravato label requires monitoring for at least two hours after each dose. So plan your rooms and staffing around this time.

5. Secure malpractice and liability insurance

Get quotes for professional liability early. Some founders report that several carriers declined to cover IV ketamine before one agreed. Also ask about general liability, property and cyber coverage. If you use locum or agency clinicians, confirm who provides their malpractice cover.

6. Lease and build out the space

Look for a space with private treatment rooms, a calm waiting area and room for patients to recover. Infusion and Spravato rooms need space for monitors, a recliner and an observer. If you plan to add TMS, check the electrical supply and room size with the device maker before you sign a lease.

When you compare locations, look at these points:

• Local demand. Check how many psychiatrists and therapists practice nearby. They are your main referral sources.
• Access. Patients often cannot drive after ketamine or Spravato visits. So choose a spot with easy drop-off and pick-up.
• Privacy. A quiet building with a discreet entrance helps patients feel comfortable.
• Hiring market. Check whether you can recruit nurses, CRNAs and prescribers in the area. A great location means little if you cannot staff it.
• Room to grow. Leave space to add treatment rooms or a TMS chair later.
• Zoning and building rules. Confirm the space can be used as a medical clinic before you sign.

Questions to settle before you sign a lease

Ask the landlord about hours of access, after-hours security and parking. Also ask whether you can make changes to rooms and electrical supply. Finally, check how long the lease runs. A shorter first term, with an option to renew, can lower your risk while the clinic grows.

7. Buy equipment and set up your drug supply

For ketamine and Spravato, you will usually need infusion pumps, vital-sign monitors, a crash cart, an AED, oxygen and suction. You also need an EHR that handles consent forms and outcome tracking. In addition, set up accounts with licensed distributors early. Drug shortages and distributor order limits have caught some new clinics off guard.

8. Write clinical protocols that follow current standards

Write clear protocols for patient screening, consent, dosing, monitoring, discharge and emergencies. In 2026, the American Society of Ketamine Physicians, Psychotherapists and Practitioners (ASKP3) published consensus standards for IV ketamine. According to a Psychiatric Times summary, they call for:

• A setting that can provide cardiorespiratory monitoring
• Trained, team-based staff
• A full psychiatric evaluation before any infusion
• Tracking of patient outcomes over time

Your medical director should review these standards and adapt them to your state’s rules.

9. Credential with payers and set up billing

Even if IV ketamine will be cash-pay, Spravato and TMS are usually billed to insurance. Payer credentialing can take several months. Therefore, start it as soon as your prescribers are licensed at your location. Also decide whether you will run billing in-house or use a billing service.

10. Hire and train your team

Hiring often takes longer than owners expect. This is especially true for psychiatrists and CRNAs. Start recruiting your medical director first, because many other steps depend on them. Then add nurses, technicians and front-desk staff. See the staffing section below for each role.

11. Market your clinic responsibly

Build referral relationships with local psychiatrists, therapists and primary care practices. Be careful with ads. Some ad platforms restrict ads for controlled substances, and some need third-party certification, such as LegitScript. Avoid any claims about cures or guaranteed results.

Opening a ketamine or TMS clinic? We recruit medical directors, psychiatrists, PMHNPs and nurses. Get a staffing quote →

How to Start a TMS Clinic or Add TMS to Your Practice

Many ketamine clinics add TMS later, and many psychiatry practices start with TMS alone. Here is what to plan for.

Choose an FDA-cleared device

Several companies make FDA-cleared TMS devices. They differ in coil type, session length, cleared uses and pricing. Some sell the device outright, while others offer a monthly subscription or per-session pricing. Compare total cost over five years, not just the upfront price. Also ask about training, service and uptime guarantees.

Understand supervision rules

Payers usually require a psychiatrist to order the treatment course. Many also require a physician to supervise sessions. For example, a 2026 Medicare contractor policy update (LCD L33398) required direct supervision by an MD or DO. Supervision rules vary by payer and region, so check each payer’s current policy.

Plan for prior authorization

Most payers require prior authorization before TMS starts. Policies often ask for a psychiatric evaluation and records of earlier treatment. According to Clinical TMS Society guidance, an initial course often covers up to 36 sessions. As a result, a dedicated prior-authorization coordinator can make a big difference to cash flow.

How Much Does It Cost to Open a Ketamine Clinic?

Published startup figures range from about $10,000 to $500,000. That wide range reflects very different clinic sizes and models. The table below breaks costs down by item. These are industry estimates, not quotes, so always get local prices.

Cost item	Lean add-on	Mid-size standalone	Larger multi-service clinic
Lease deposit and buildout	Use existing space	Moderate buildout of 2–4 rooms	Full buildout of 5+ rooms
Medical equipment (pumps, monitors, crash cart, AED, recliners)	A few thousand dollars per room	Several rooms’ worth	Full set for each room
TMS device	Not included	Subscription or lease	Purchase, often tens of thousands to over $100,000
EHR and practice software	Monthly subscription	Monthly subscription	Monthly subscription plus billing tools
Licenses, DEA registration and legal fees	Required	Required	Required for each location
Malpractice and other insurance	Yearly premium	Yearly premium	Higher premium for more services
Payroll before opening and during ramp-up	Part-time staff	Core team	Full team, often the largest cost
Working capital reserve	Several months of costs	6–12 months of costs	6–12 months of costs

Some industry guides suggest keeping $75,000–$150,000 in reserve, plus 6–12 months of operating cash. This matters because early patient volume is often low.

Ongoing monthly costs

After opening, your main costs are payroll, rent, drug and supply costs, insurance, software, billing and marketing. For most clinics, payroll is the largest line. That is why getting the staffing mix right early has such a big effect on profit.

How long until a ketamine clinic breaks even?

There is no standard answer. However, founders and industry guides often report a slow first year, with only a few patients in the first months. A clinic that adds Spravato or TMS may reach steady volume faster, because insurance covers those services. Still, payer approvals take time, so plan your cash flow carefully.

Billing Codes for Ketamine, Spravato and TMS

Use this table as a starting point. Always confirm codes and rules with each payer, because policies change.

Service	Code(s)	Notes
TMS, first session (includes motor threshold)	CPT 90867	Not billed on the same day as 90868 or 90869
TMS, later sessions	CPT 90868	Usually needs prior authorization
TMS, motor threshold re-check	CPT 90869	Used when the threshold is measured again
Spravato for Medicare patients (56 mg / 84 mg)	HCPCS G2082 / G2083	Created by CMS in 2020. Covers the visit, observation and the drug
Spravato drug for most other payers	HCPCS J0013	Replaced S0013 on January 1, 2026
Office visit with Spravato (non-Medicare)	E/M codes, plus 99415/99416 where allowed	Prolonged-service codes may apply to the observation time
IV infusion	CPT 96365 / 96366	Psychiatric IV ketamine is usually cash-pay

Sources: CMS CY2020 Physician Fee Schedule final rule; Spravato manufacturer coding guide (Dec 2025); payer TMS policies. Confirm all codes with your payers.

Staffing a Ketamine and TMS Clinic

Your team is the heart of a safe clinic. It is also your biggest cost. The table below shows the core roles, with national median pay from the Bureau of Labor Statistics where it is available.

Role	Main duties	Typical license	BLS median pay (May 2025)
Medical director / psychiatrist	Protocols, evaluations, orders, supervision	MD or DO, state license, DEA registration	$281,870 (psychiatrists)
Anesthesiologist	Protocol design, sedation oversight	MD or DO	$391,490
CRNA	IV ketamine administration and monitoring, where state rules allow	CRNA license	$236,590
Psychiatric nurse practitioner (PMHNP)	Evaluations, prescribing, follow-up, where state rules allow	APRN license, DEA registration	$132,300 (nurse practitioners)
Registered nurse	IV placement, monitoring, patient education	RN license, ACLS often required	$97,550
TMS technician	Runs TMS sessions under supervision	Device training; varies by state and payer	No separate BLS category
Front desk / prior-authorization coordinator	Scheduling, intake, payer approvals	None required	Varies by market

Source: BLS Occupational Outlook Handbook, May 2025 data.

Medical director or psychiatrist

This is your most important hire. The medical director signs off on protocols, oversees safety and often orders TMS courses. Look for experience with interventional psychiatry, if possible. You can learn more about how we recruit for this role on our Hire a Psychiatrist page.

CRNA or anesthesiologist

Some clinics use CRNAs or anesthesiologists to give IV ketamine. Others use them to design protocols and train nurses. What is allowed depends on your state, so confirm the scope of practice first.

Nurse practitioners and nurses

PMHNPs can do evaluations and follow-up visits in many states. Nurses usually start IVs, monitor patients and handle discharge. ACLS training is commonly required for staff who monitor ketamine patients. See how we recruit for the PMHNP role on our Hire a PMHNP page.

TMS technicians

TMS technicians run daily sessions. Device makers usually provide training. Because there is no single national license, check your state and payer rules on who may operate the device.

Sample staffing plan by clinic stage

You do not need a full team on day one. Instead, many owners grow the team in stages as patient numbers rise. The plan below is a simple example. Adjust it to your state’s rules, your hours and your services.

Role	Launch (first 3–6 months)	Growing clinic	Multi-service or multi-site
Medical director / psychiatrist	Part-time or locum	Part-time to full-time	Full-time, plus site leads
Prescriber (psychiatrist, PMHNP or psychiatric PA)	1 part-time	1–2	2+ per site
CRNA or anesthesia support	As needed, if your state or protocols require it	Scheduled infusion days	Regular cover for each infusion day
Registered nurse	1	2–3	Several per site
TMS technician	1, if you offer TMS	1–2	Based on chair count
Front desk and prior authorization	1 combined role	2 separate roles	Central billing and intake team

How long it takes to hire each role

Hiring times vary by market. Still, some roles are much harder to fill than others. So start the hardest searches first.

• Psychiatrists and medical directors: usually the longest search. In addition, a new state license, DEA registration and payer credentialing can each add weeks or months.
• CRNAs and anesthesiologists: often hard to find for outpatient work. Part-time or per-diem arrangements can help.
• PMHNPs: in high demand, especially for telehealth roles. Also check your state’s practice authority rules.
• Nurses and TMS technicians: usually faster to hire. However, plan time for device and protocol training.

Using locum and per-diem staff during ramp-up

Early patient volume is often low. So many new clinics start with part-time or per-diem clinicians, then add full-time staff as volume grows. A locum tenens psychiatrist can also cover the medical director role while you search for a permanent hire.

Safety and Emergency Readiness Checklist

Patient safety is the foundation of any ketamine or TMS clinic. It also matters to insurers, payers and state inspectors. Use this checklist as a starting point, and have your medical director adapt it to your state’s rules.

• ☐ Written screening, consent, monitoring and discharge protocols
• ☐ Vital-sign monitoring, and capnography where your state or protocols require it
• ☐ Crash cart, AED, oxygen and suction checked on a set schedule
• ☐ At least one ACLS-trained clinician on site during every ketamine session
• ☐ Regular emergency drills, with a written record of each one
• ☐ A clear plan for transfer to a hospital if needed
• ☐ A ride-home policy for patients after ketamine or Spravato visits
• ☐ Secure, locked storage and up-to-date records for all controlled substances
• ☐ A process to track patient outcomes over time
• ☐ HIPAA privacy and security policies, plus staff training

Controlled Substance Records: What the DEA Expects

Because ketamine and Spravato are Schedule III drugs, good record keeping is not optional. In general, a registered clinic must keep accurate records of every controlled substance it receives, gives or disposes of. It must also take regular inventories and report any theft or significant loss to the DEA. In addition, only authorized staff should have access to the drug supply.

Many new clinics assign one person, often the medical director or a lead nurse, to own these records. This makes audits easier and reduces the risk of mistakes. Your pharmacist, distributor or healthcare attorney can help you set up the right process.

Pre-Opening Timeline: Month by Month

Every clinic is different, but this sample timeline shows the usual order of steps.

When	What to do
Months 1–2	Choose your service model, form the entity, check ownership rules and start recruiting a medical director.
Months 2–3	Sign the lease, apply for state licenses and request insurance quotes.
Months 3–4	Apply for DEA registration once the address and state license are in place. Order equipment and choose an EHR.
Months 3–5	Start payer credentialing. Begin REMS certification if you offer Spravato.
Months 4–5	Hire nurses, technicians and front-desk staff. Write and test protocols.
Month 5–6	Run emergency drills, train staff, start marketing and open your doors.

8 Mistakes That Sink New Ketamine and TMS Clinics

1. Running out of cash. Early volume is often low. Keep a reserve that covers 6–12 months.
2. Hiring the medical director too late. Licenses, protocols and payer applications often depend on this person.
3. Skipping the ownership check. Breaking your state’s CPOM rules can put the whole business at risk.
4. Leaving insurance until the end. Malpractice cover for ketamine can be hard to find.
5. Underestimating payer delays. Credentialing and prior authorizations slow cash flow for Spravato and TMS.
6. Overstaffing too early. Start lean and add staff as patient numbers grow.
7. Making treatment claims in ads. This can break ad-platform rules and create legal risk.
8. Relying on one service. Market shifts can hit single-service clinics hard. Many owners add a second service line over time.

Questions to Ask a Staffing Partner

• Have you recruited for ketamine, Spravato or TMS clinics before?
• Can you recruit a medical director and the rest of the team?
• Do you check state licenses, DEA registration, board status and ACLS?
• Can you offer locum or per-diem cover while we ramp up?
• How do you charge, and what guarantee do you offer?
• Can you recruit for several locations or states?

Ketamine and TMS Clinic Staffing Checklist

• ☐ Medical director hired (psychiatrist or other physician, as your state requires)
• ☐ Prescribers licensed in your state, with a DEA registration at your location
• ☐ State scope-of-practice rules checked for CRNAs, NPs and RNs
• ☐ ACLS (and PALS, if you see minors) training current for monitoring staff
• ☐ REMS training complete for Spravato staff
• ☐ TMS technicians trained on your device
• ☐ Prior-authorization and billing roles covered
• ☐ Backup cover planned for leave and sick days
• ☐ Payer credentialing started for every billing clinician
• ☐ Malpractice cover confirmed for every clinician, including locums

How Pulivarthi Group Helps You Staff a New Clinic

Pulivarthi Group has 15 years in healthcare staffing and more than 20,000 licensed clinicians in our network. We recruit psychiatrists, PMHNPs, psychiatric PAs, nurses and other mental health professionals. We offer permanent, temporary, contract, per-diem and executive search options. In addition, we verify credentials and licenses across all 50 states, and every placement comes with a 30-day placement guarantee. Learn more about our mental health staffing services.

Ready to build your clinic team? Tell us who you need in 60 seconds. Get a staffing quote →

Frequently Asked Questions

How much does it cost to open a ketamine clinic?

Published estimates range from about $10,000 for a small add-on to $500,000 or more for a large standalone clinic. The biggest costs are buildout, equipment, insurance and payroll. Many guides also suggest keeping 6–12 months of operating cash in reserve.

What licenses do I need to open a ketamine clinic?

You usually need a business entity and EIN, any state clinic license, state licenses for each clinician, an NPI, and a DEA registration for each location. If you offer Spravato, you also need REMS certification. Check your state’s rules, because they vary.

Do you need to be a doctor to own a ketamine clinic?

It depends on the state. Some states have corporate practice of medicine rules that limit ownership by non-physicians. In those states, owners often use a management services organization working with a physician-owned practice. Ask a healthcare attorney in your state.

Can a nurse practitioner or CRNA run a ketamine clinic?

In some states, nurse practitioners can evaluate patients and prescribe, and CRNAs can give IV ketamine. However, rules on supervision and ownership differ widely. Confirm your state’s scope-of-practice rules before you plan your team.

Does insurance cover ketamine infusions?

Insurers rarely cover IV ketamine for psychiatric use, so most clinics offer it as cash-pay. Spravato and TMS, on the other hand, are often covered by commercial plans and Medicare, usually with prior authorization.

Should I offer IV ketamine or Spravato?

It depends on your patients, payer mix and space. IV ketamine is usually cash-pay and needs infusion equipment. Spravato is often covered by insurance but requires REMS certification and at least two hours of monitoring per dose. Many clinics offer both.

How much space do you need for a ketamine or TMS clinic?

A small clinic can start with a few private treatment rooms, a waiting area and an office. Each ketamine or Spravato room needs space for a recliner, monitors and an observer. For TMS, check the device maker’s room and electrical requirements.

Who can administer TMS?

A psychiatrist or other physician usually orders and supervises the course. Trained TMS technicians often run the daily sessions. Supervision rules vary by payer and region, so check each payer’s current policy.

How long does it take to open a ketamine clinic?

Many clinics take about five to six months from planning to opening. The slowest steps are usually hiring the medical director, getting the DEA registration and finishing payer credentialing.