General Information

Consent & Notice of Privacy Practices

Purpose of Consent: By signing this form, you will consent to our use and disclosure of your protected health information to carry out treatment, payment activities, and healthcare operation.

Notice of Privacy Practices: You have the right to read our Notice of Privacy Practices before you decide whether to sign this Consent. Our Notice provides a description of our treatment, payment activities, and healthcare operations, of the uses and disclosures we may make of your protected health information, and of other important matters about your protected health information.

We reserve the right to change our privacy practices as described in our Notice of Privacy Practices. If we change our privacy practices, we will issue a revised notice of Privacy Practices, which will contain the changes. Those changes may apply to any of your protected health information that we maintain.

You may obtain a copy of our Notice of Privacy Practices, including any revisions of our Notice, at any time by contacting us by phone or email.

Right to Revoke: You will have the right to revoke this Consent at any time by giving us a written notice of your revocation submitted to the Contact Person listed above. Please understand that revocation of this Consent will not affect any action we took in reliance of this Consent before we received your revocation, and that we may decline to treat you or to continue treating you if you revoke this Consent.

Signature

NOTE: Both Doctor and patient are encouraged to discuss any and all relevant patient health issues prior to treatment.

All parties involved agree that this document may be signed electronically. The electronic signatures appearing on this document are the same as handwritten signatures for the purposes of validity, enforceability, and admissibility.

General Information

PATIENT CONSENT FOR TMS (IF APPLICABLE) AND TREATMENT

TMS: TMS is prescribed and directly supervised by psychiatrists who are trained in TMS. It is administered by trained TMS technicians who are familiar with different TMS protocols but may only administer exactly what is prescribed. They are not clinicians and may not make treatment recommendations; they administer TMS all day every day and are trained to handle an emergency. Physician supervision takes place in many ways.

Treatment progress is checked through patient rating scales and follow-up appointments. Rating scales are required for data collection and insurance coverage determinations. If there is some uncertainty about whether to continue TMS or change the protocol, the technician will contact the physician for directions.

Risks and Discomforts

TMS has been used worldwide since 1985 and FDA approved since 2008; however, there are a series of adverse effects that may occur from TMS.

I understand the following adverse effects are possible:

1. Up to 10% of patients undergoing TMS experience headaches, face pain, jaw pain, tooth pain or neck pain. You can take ibuprofen, acetaminophen, or aspirin, which in most cases relieve the pain. Almost all patients find TMS to be tolerable.
2. TMS produces a loud clicking noise during stimulation, which can result in tinnitus or hearing loss especially if ear protection is not used. To prevent risk of hearing disturbances, earplugs will be given to wear.
3. TMS can induce a seizure even in the absence of brain lesions, epilepsy, or other risk factors for seizures. The overall risk for seizures during TMS is not known but it is less frequent than 0.5% or 5 in 1,000 patients. TMS does not cause epilepsy. In patients with known epilepsy, the risk is 1%.
4. TMS could potentially cause unintended teeth clenching, biting of the tongue, and chipping teeth. The overall risk for this is not known. If this occurs, we will supply a mouthguard for your comfort. Please request one.
5. TMS could theoretically induce transient changes in cognition or movement, although safety studies have not found such side effects to date.

Psychotropic medications in general slightly increase a person's rate of seizures, independent of TMS. There is no connection between these medications and seizing during TMS, as many have been used without incident, however changing these medications need to be discussed with the TMS team and noted by the psychiatrist. Withdrawal from some medications can increase risk for seizures, so Duluth & St. Cloud TMS would redetermine the motor threshold and adjust the stimulus intensity if medications were adjusted.

Alcohol and drug use can have a strong impact on the risk of seizures during TMS treatment. Do not drink alcohol prior to treatment, and do not increase your overall alcohol intake while receiving therapy. Patients who come in smelling of alcohol will be asked to reschedule when it is safe for them to receive treatment. The use of cannabis is not contraindicated for TMS; however, other drugs should be avoided during treatment.

Sleep deprivation has long been identified as a trigger for a seizure. Sleep changes must be discussed with the TMS technician. TMS stimulates the brain, and if you are extremely tired, this can cause adverse effects. Focus on good sleep hygiene while you are receiving TMS therapy.

To date there is only one absolute contradiction for repetitive TMS - the presence of ferromagnetic substance in the head. Ferromagnetic means a substance that is highly susceptible to magnetization. We do not know about the long-term consequences of TMS, since it was only FDA approved for depression in 2008. It is strongly recommended not to interrupt your treatment during the acute phase.

I understand that Duluth & St. Cloud TMS will not compensate me for injuries that may or may not have occurred from an adverse reaction to TMS. Reasonable medical treatment will be offered for injuries directly caused by my TMS treatment, for which the insurer or I will be billed at the usual fee. I release Duluth/St. Cloud TMS and all the providers and technicians from all liabilities and expenses related to my decision to receive TMS as part of my care.

I understand that I have the option to obtain treatment elsewhere and will be provided with a referral letter if needed.

I am aware there may be unexpected complications.

I am aware that the risks of exposure to a magnetic field during pregnancy are not fully understood.

Clinic Policies

Code of Conduct: Duluth & St. Cloud TMS is committed to supporting a culture that values integrity, honesty, and fair dealings with each other. We promote an environment that is professional that exemplifies outstanding patient care. To support safety, respect, and treatment efficacy, the employees, and patients of Duluth & St. Cloud TMS must adhere to the following expectations. Refrain from:

• Using profane, disrespectful, insulting, demeaning or abusive language
• Inappropriate arguments between patients and staff
• Boundary violations
• Outburst of anger
• Insensitive or inappropriate comments about a person's medical condition, appearance, situation, etc.
• Throwing or breaking things
• Use or threat of unwarranted physical force with patients, employees, family members, providers, or other caregivers
• Threats to patients, employees, providers, or property

Emergency Services

Duluth & St. Cloud TMS is not an emergency clinic, and there is no guarantee to discuss ongoing care with your provider outside of an appointment. If you are experiencing side effects from a treatment or medication received at our clinic during regular business hours, please contact the clinic and we will aid you as much as possible. Text messages, voicemails, and the patient portal are checked throughout the day.

If you cannot connect with the team during regular business hours, and you experience what feels like an emergency, please go to your local hospital, call 911, your medical group, or your primary care physician. Clinicians and employees are not available after hours. Below is a list of some crisis phone numbers:

Statement of Financial Responsibility

I acknowledge that I am legally responsible for all these charges for the services provided to me by Duluth & St. Cloud TMS to the extent those charges are not covered or paid by my insurance carrier, including Medicare. I understand my insurance carrier may not approve or pay for the services provided by Duluth & St. Cloud TMS. I understand that I am personally responsible for payment of all charges not covered insurance, co-payment, policy deductibles, and co-insurance except where my liability is limited by contract or State or Federal law. I acknowledge that I am legally responsible for all charges associated with the provision of non-covered and/or non-medically necessary services. In case of non-payment, I understand non-payment may be reported to credit reporting agencies. I agree to pay all reasonable costs of collection including attorney's fees. Duluth & St. Cloud TMS is authorized to access credit bureau files and reports now and in the future for collection purposes.

I agree to allow Duluth & St. Cloud TMS to release information about my medical treatment to any private or government insurance program that covers me, including Medicare and Medicaid, as necessary to verify benefits, authorize services, process medical claims, and provide medical necessity.

Late Cancellation and Missed Appointments

Duluth & St. Cloud TMS has a strict policy for not complying to scheduled appointments. Please contact us if you need to reschedule any appointment. Treatments such as TMS, IV Ketamine, and Spravato only work if patients attend regular sessions. If you cannot make it consistently, we may ask that you reschedule during a time that is more manageable for your schedule.

Medication management and talk therapy requires a commitment to attending regularly scheduled appointments for proper case management.

Missing provider appointments: cancellation with less than 24-hour notice (business hours), or not arriving via telehealth link, phone call, or in person appointments will result in the consequences. If you miss 1 appointment, the team will reach out and discuss the ramifications. The second time this occurs, you may be terminated from the clinic or billed a $50 failed appointment fee that is not reimbursed by insurance. Missing multiple appointments is considered treatment abandonment, as proper care cannot be given to those who do not attend the schedule that is necessary for effective therapy.

I agree to attend scheduled appointments or contact the clinic at least 24- business hours before cancellation of scheduled appointments. I understand that missing appointments may interfere with my overall treatment plan and can be considered abandonment of care. Controlled medication involves a specific treatment plan that requires multiple appointments per year. If those appointments are missed, I understand that my usual dose may be lowered or may have to wait to get a refill until I can be seen again.

Insurance

Duluth & St. Cloud TMS is in network with most insurance plans and eligibility will be checked prior to each appointment that you attend. Before you start treatment, we will contact your insurance company to obtain prior authorization if needed. However, that is not a guarantee of benefits. If your insurance is cancelled during treatment, you will be responsible for the cost of treatment. It is also your responsibility to update your coordination of benefits with your insurance company and the team during and after treatment. Our office will do our best to get the most accurate cost of treatments but ultimately it is your responsibility to be prompt and cooperative with insurance changes and requests. If you do not, the cost will transfer to patient responsibility.

Clients Rights and Consent for Services

I have read and understand the policies above. I further understand the information I have given is to be used for management purposes and the clinic will ensure confidentiality. I may inquire about or object to the methods and or type of information stored. My rights are protected under the State and Federal Confidentiality laws and any release of information requires my consent except when needed and allowed by law, including child abuse and/or neglect and the intent to harm others or myself. I give Duluth & St. Cloud TMS my consent to supply evaluation, treatment, and other services as we mutually decide to be proper. I am taking part voluntarily, and I understand my right to refuse or stop treatment at any time. I have had the opportunity to discuss my reasons for seeking services and I understand my responsibilities in the relationship I have with Duluth & St. Cloud TMS.

NOTE: BOTH DOCTOR AND PATIENT ARE ENCOURAGED TO DISCUSS ANY AND ALL RELEVANT PATIENT HEALTH ISSUES PRIOR TO TREATMENT.

All parties involved agree that this document may be signed electronically. The electronic signatures appearing on this document are the same as handwritten signatures for the purposes of validity, enforceability, and admissibility.