TMS Packet – PAKC

Psychiatry Associates of Kansas City (PAKC)
Advanced Psychiatric Solutions of Kansas City (APSKC)
Informed Consent Document
Transcranial Magnetic Stimulation Therapy (TMS)

Date

Patient Name

Psychiatrist

Informed Consent

This is the patient informed consent document (ICD) for Transcranial Magnetic Stimulation Therapy (TMS). This ICD describes the TMS treatment that your psychiatrist has prescribed and outlines for you the risks, potential benefits, and any alternative treatments if you decide not to be treated with TMS. You will be receiving TMS for the treatment of Major Depressive Disorder (MDD) or for Bipolar Depression.

What is TMS?

Transcranial Magnetic Stimulation (TMS) is a noninvasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing electrical currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue.

When the induced field is above a certain threshold, and is directed in an appropriate orientation relative to nerve cell circuits in the brain that are involved in regulating mood and other symptoms that occur in depression, then neurons in those circuits are affected in a way that is believed to lead to improvement in depressive symptoms.

TMS is a technique approved by the Food and Drug Administration (FDA) for the treatment of MDD and several devices have been cleared by the FDA for providing TMS therapy. The device that will be used in your treatments is the MagStim Rapid2 System or the MagVenture MagPro.

How does it work?

At your first TMS treatment session, your psychiatrist and a trained TMS technician will place the magnetic coil over your scalp on the appropriate region of your head.

In order to calibrate the intensity of TMS that you will need, we will stimulate the region of your brain that makes the thumb move. You will hear a clicking sound and feel a tapping sensation on your scalp. The device will be adjusted to give just enough energy to send electromagnetic pulses into the brain so that your thumb twitches.

The intensity of stimulation that barely produces a movement in the thumb is called the motor threshold (MT). Once your MT is determined, the magnetic coil will be moved to the location of the brain that scientists think may be responsible for causing depression. The stimulation will be set to 120% of your MT.

During your series of TMS treatments the MT and precise placement of the coil will be periodically reevaluated by your psychiatrist. After the first treatment, subsequent treatments may be given by the technician alone, but your psychiatrist, or a covering colleague of your psychiatrist trained in TMS, will be immediately available for an emergency or other urgent matters. Any required re-determinations of the MT or coil positioning during your treatments will be performed by your psychiatrist.

Each treatment session is delivered as a series of pulses (called a “train”), followed by a wait period. There will be a total of 3000 pulses over the treatment session. The settings of the TMS device may be changed during the treatment series, depending on your response.

Treatment is targeted to the region of your brain called the dorsolateral prefrontal cortex (DLPFC), a region that scientists believe is involved in depression.

We plan to provide 30 treatment sessions in the treatment of your depression. These treatments will be given Mondays through Fridays for 6 consecutive weeks. This is called an “acute series.”

The number of treatments that you are given might be more or less than 30 depending on the psychiatrist’s assessment of your progress, including side effects. A change in the number or frequency of treatments will be made, with your approval, after discussion with the prescribing physician.

Depending on the severity of your depression, past history of relapses, response to TMS, and ability to tolerate TMS treatments, your psychiatrist might recommend periodic maintenance treatments beyond this acute series.

Periodically during the acute and maintenance treatment series you will complete a form called the Personal Health Questionnaire-9 (PHQ-9). This scale is useful in monitoring the progress in the response of your depression to TMS. The PHQ-9 might also be required by your insurance company for initial and continued approval of coverage for TMS treatments.

TMS treatments do not involve any anesthesia or sedation and you will remain awake and alert during the treatment. You may be evaluated by a healthcare provider during this treatment course.

Is the treatment effective?

Three published large randomized controlled trials (RCT) support TMS as an effective treatment for MDD in patients who have not benefitted from traditional antidepressant medications. An RCT is considered the best standard for evaluating the safety and effectiveness of medical treatments.

Multiple other studies have also supported the use of TMS for the treatment of MDD. If you have questions regarding these studies and statistics regarding effectiveness reported in these studies, please speak with your psychiatrist before signing this informed consent document.

TMS and Bipolar Depression

TMS has not been established as safe and effective by the FDA for the treatment of Bipolar Depression. Research studies have indicated that Bipolar Depression might be effectively treated by TMS, although there is risk for such treatments to cause a manic or hypomanic episode.

Use of TMS for treating Bipolar Depression is considered “off-label,” which means that your doctor might conclude that TMS is an appropriate treatment for you as an individual even with the recognition that it is not FDA-approved. However, we are unaware of any insurance plan that covers TMS for the treatment of Bipolar Depression.

Are there potential contraindications or risks?

The long-term effects of exposure to magnetic fields are not known.

TMS is not effective for all patients with depression. Any symptoms or behaviors suggesting a worsening depression or signs of suicidal thoughts or behaviors should be reported immediately to your psychiatrist. We recommend a family member or caregiver monitor your symptoms to help you spot any signs of worsening depression or suicidal behavior.

Symptoms which you need to report include, but are not limited to, increasing depression, increasing irritable or anxious moods, increasing difficulty sleeping or excessive sleeping, loss of appetite and weight loss, increasing fatigue, increasing lack of interests and motivation, feelings of hopelessness and helplessness, and increasing thoughts of death, including suicidal thoughts.

TMS cannot be given to patients who have certain medical conditions or implanted devices. If you have one of these conditions and undergo a TMS treatment it could result in serious injury or death.

You must tell your psychiatrist if you have a history of any of the following health conditions:

History of Seizure or Stroke
Severe Heart Disease
Migraines
Epilepsy
Electrolyte imbalance
Pregnancy

You must tell your psychiatrist if you have any of the following items in or on your body:

Aneurysm clip or stent or suture
Defibrillator or pacemaker
Insulin pump
Deep brain, vagus nerve, or bone growth stimulators
Cochlear implants
Bullet fragments
Facial tattoos or permanent makeup which contains any metals
Other devices which might contain metal that are implanted in, or around, your head, neck, or chest

Even non-metal objects can be affected by the magnetic field. If you have a removable device or object that may be affected by the magnetic field, you must remove the device from the patient area before treatment to prevent possible injury to you or staff or damage to the device.

Examples of items that need to be removed include, but are not limited to: earrings, hearing aids, eyeglasses, jewelry, hair barrettes, cell phones, MP3 players, wearable monitors, etc.

There is a risk of having a seizure while undergoing TMS. This occurs in about 1 in every 30,000 treatment sessions, or 1 in 1,000 patients.

Some patients with a personal history or family history of seizure or epilepsy, a history of stroke, head injury or trauma, presence of other neurological disease (cerebrovascular accident, cerebral aneurysm, dementia, increased intracranial pressure, or movement disorder), neuroleptic medications, or other drugs known to lower the seizure threshold may be at increased risk of seizure.

Your psychiatrist will review your medical history, including current medications, and this will help determine if you are at an increased risk for seizures. Alcohol withdrawal has been associated with seizure occurring during TMS. Therefore, it is important that you discuss your alcohol use history with your psychiatrist before agreeing to treatment and follow the psychiatrist’s instructions regarding alcohol usage.

Due to the loud sound associated with TMS, earplugs or similar hearing protection devices with a rating of 30dB or higher of noise reduction must be used during treatment. Your hearing will be assessed before we begin treatments, and again once they are completed. Your insurance may be charged for this.

The most common adverse events reported are application site pain or discomfort and headache. If you experience these, we may be able to modify the location or intensity of the treatment, or you can use over-the-counter analgesics for relief.

I understand that there are other treatment options that are considered safe and efficacious (including, but not limited to, medications, psychotherapy, Vagus Nerve Stimulator therapy, and ECT). These options have been discussed with my psychiatrist.

I further understand that no guarantee of any results has been made. I understand that if the psychiatrist or other treating staff determine during the course of treatment that I require emergency treatment, I hereby authorize and request that such treatment be performed.

I understand that I can change my mind any time, and choose a different option. I voluntarily choose to receive TMS Therapy and authorize the psychiatrists and associated staff of PAKC and APSKC to perform such treatments.

Initial Here

Important Information about TMS:

TMS is a 9 week commitment.

Daily standing appointments (times do not change) for 6 weeks, then a taper over 3 weeks.

Please be committed to your daily appointments, as consistent daily treatment can affect success and remission.
Taper appointments are just as important as the daily treatments during the first 6 weeks.
Patients who fail to keep a mapping appointment without calling to cancel will be assessed a $100 fee. All other TMS appointments that are missed without calling to cancel or reschedule will be assessed a $50 fee as above.

Initial Here

By signing below, I am indicating I have read the information contained in this Consent Form about TMS therapy. I understand the risks and benefits of the TMS procedure: I have discussed this treatment with my treating psychiatrist and/or his designee, and all of my questions have been answered. I have reviewed the list of potential contraindications and advised my psychiatrist any which might apply. With knowledge of all this information, I wish to go forward with the TMS procedures which have been prescribed for me.

Patient Signature

Date

Transcranial Magnetic Stimulation Therapy for the Treatment of Depression Pregnancy and Breastfeeding Informed Consent Document

First Name

Last Name

I am verifying that I:

Am Pregnant May be pregnant and consent to a preganacy test to verify the same. May be pregnant and do not consent to a pregnancy test to verify the same.

If Pregnant, how many weeks?

I believe I am not pregnant due to:

Pregnancy Test (conducted on)

First day of last menstrual period

I am verifying that I:

Am not breastfeeding Am currently breastfeeding Plan to begin breastfeeding with the next week.

Patient Name

Patient Signature

Date

Transcranial Magnetic Stimulation Therapy Statement of Patient Responsibility

Patient Name

Date of Birth

PATIENT FINANCIAL RESPONSIBILITY POLICY

In a separate document, Psychiatry Associates of Kansas City described the use of Transcranial Magnetic Stimulation ("TMS") therapy for treating depression to help you decide if you want to be treated with TMS.

The service that you have elected to participate in implies a financial responsibility on your part. This responsibility obligates you to ensure payment in full of our fees.

As a courtesy, we will verify your coverage and bill your insurance carrier on your behalf. However, you are ultimately responsible for your bill.

You are responsible for payment of any deductible and/or co-payment/co-insurance as determined by your contract with your insurance carrier. We expect payment at the time of service.

Many insurance companies have additional stipulations that may affect your coverage. You are responsible for any amounts not covered by your insurer.

If your insurance carrier denies any part of your claim, or if you or your physician elect to continue past your approved period, you will be responsible for your balance in full.

ACKNOWLEDGMENT OF RESPONSIBILITY (PLEASE INDICATE YOUR AGREEMENT BY INITIALING BESIDE EACH STATEMENT):

I understand that my insurance carrier may not cover TMS therapy and I will be responsible for any amount due after payment has been made by my insurance carrier and/or any amount not covered by my insurance carrier.

I understand that insurance prior authorizations might provide coverage for a specific number of treatments initially, but refuse additional authorizations later in the series. If my psychiatrist and I determine it is in my best interest to continue with the TMS therapy, I understand that I will be responsible for any amount not covered by my insurance carrier.

I understand that if I choose to terminate TMS therapy early, or if the course of TMS therapy is altered to accommodate my finances (e.g., tapering), the therapeutic effect of TMS therapy may be blunted and may be counter-therapeutic.

I understand that a typical TMS treatment course will involve approximately 30 treatment sessions given over 6 consecutive weeks. If I fail to pay for or attend the set appointments, it will likely reduce the likelihood for success and may increase risks. Therefore, in the event I miss 2 consecutive appointments, or 3 total appointments, TMS therapy may be terminated.

I understand TMS therapy may be terminated early if I fail to meet my financial obligations to Psychiatry Associates of Kansas City.

I understand that if TMS therapy is tenninated early, for any reason, the therapeutic effect ofTMS therapy may be blunted, may be counter-therapeutic and may exclude me from any future TMS therapy options.

AGREEMENT TO PATIENT FINANCIAL RESPONSIBILITY POLICY

I have read the above patient policy regarding my responsibility to Psychiatry Associates of Kansas City for providing TMS therapy to me or the above-named patient, and agree to be bound by the patient financial responsibility policy.

I authorize my insurer to pay any benefits directly to Psychiatry Associates of Kansas City, the full and entire amount of the bill incurred by me or the above-named patient.

If applicable, I agree I am responsible for any amount due after payment has been made by my insurance carrier and/or any amount not covered by my insurance carrier.

Patient Name

Patient Signature

Date

REVIEW OF SYSTEMS

Patient Name

Date

Reproductive

Erectile Dysfunction Penile Discharge Sexual Dysfunction Other

Hematological / Lymphatic

Easy Bleeding Easy Bruising Lymphadenopathy Other

The Patient Health Questionnaire (PHQ-9) - Overview

Patient Name

Date

Over the past 2 weeks, how often have you been bothered by any of the following problems? *

Little interest or pleasure in doing things

Feeling down, depressed or hopeless

Trouble falling asleep, staying asleep, or sleeping too much

Feeling tired or having little energy

Poor appetite or overeating

Feeling bad about yourself – or that you’re a failure or have let yourself or your family down

Trouble concentrating on things, such as reading the newspaper or watching TV

Moving or speaking so slowly that other people could have noticed. Or, the opposite ‐ being so fidgety or restless that you have been moving

Thoughts that you would be better off dead or hurting yourself in someway

If you checked off any problems, how difficult have those problems made it for you to do your work, take care of things at home, or get along with other people?

Not difficult at all Somewhat difficult Very difficult Extremely difficult

Insurance requires a list of medications that you have tried for the treatment of Major Depression. Please list those medications below:

Please list Medication Name, Dosage, Dates Taken, Duration and Side effects/Poor Responses.
Please add one Medication per line

Insurance may also require that you have been involved in therapy with a licensed counselor. Please list that information below:

Therapist Name

Dates

Duration

Therapist Name

Dates

Duration

What time of day works best for your first 6 Weeks?

TMS is a 9 week commitment.

Daily standing appointments (times do not change) for 6 weeks, then a taper over 3 weeks.

Please be committed to your daily appointments, as consistent daily treatment can affect success and remission.
Taper appointments are just as important as the daily treatments during the first 6 weeks.

Policies & Procedures

Adminitrative Approval:

Original Date

Latest Review Date:

Revision Date:

TMS MISSED APPOINTMENT(S)

Reference Number

Policy Number

Purpose

To set the guidelines for when an active patient receiving TMS no-shows or cancels a treatment session and how that information will be disseminated.

Policy

A patient will be terminated from the current TMS program if they miss 5 treatment sessions. The patient can re-apply for the treatment at a later date.

Procedure

The receptionist for TMS will notify the patient's physician of the reason for cancellation or if the patient no-showed, and what number this missed session represents.

The technician will discuss the policy with the patient after each missed appointment to communicate how important it is for them to keep all appointments for maximum treatment benefit.

Related Policies & Procedures:

Policy/Procdure Name:

Policy Number:

Notifier:

Patient Name

Identification Number:

Advance Beneficiary Notice of Noncoverage (ABN)

Note: If Medicare doesn't pay for the services listed below, you may have to pay.

Medicare does not pay for everything, even some care that you or your healthcare provider have good reason to think you need. We expect Medicare may not pay for the services listed below.

CPT Codes	Reason Medicare May Not Pay	Estimated Cost
90867 90868 90869	Non-covered reasons: Not Medically Necessary Deemed Experimental	Initial: $497.75 Subsequent: 276.05 each / $8,005.45 Remapping: $522.96

WHAT YOU NEED TO DO NOW:

Read this notice so you can make an informed decision about your care.
Ask any questions that you may have after you finish reading.
Choose an option below about whether to receive the services listed above.

Note: If you choose Option 1 or 2, we may help you use any other insurance that you might have, but Medicare cannot require us to do this.

Check only one box. We cannot choose a box for you.

Option 1: I want the 90867 listed above. You may ask to be paid now, but I also want Medicare billed for an official decision on payment, which is sent to me on a Medicare Summary Notice (MSN). I understand that if Medicare doesn't pay, I am responsible for payment, but I can appeal to Medicare by following the directions on the MSN. If Medicare does pay, you will refund any payments I made to you, less co-pays or deductibles. Option 2: I want the 90868 listed above, but do not bill Medicare. You may ask to be paid now as I am responsible for payment. I cannot appeal if Medicare is not billed. Option 3: I don't want the options above. I understand with this choice I am not responsible for payment, and I cannot appeal to see if Medicare would pay.

Additional Information:

Signature

Date

CMS does not discriminate in its programs and activities. To request this publication in an alternative format, please call: 1-800-MEDICARE or email: AltFormatRequest@cms.hhs.gov

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-0566. The time required to complete this information collection is estimated to average 7 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection.

If you have comments concerning the accuracy of the time estimate or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore, Maryland 21244-1850.

Form CMS-R-131 (Exp. 03/2020)
Form Approved OMB No. 0938-0566

Informed Consent

What is TMS?

How does it work?

Is the treatment effective?

TMS and Bipolar Depression

Are there potential contraindications or risks?

Important Information about TMS:

Consent

INFORMED CONSENT FOR TREATMENT

PATIENT FINANCIAL RESPONSIBILITY POLICY

AGREEMENT TO PATIENT FINANCIAL RESPONSIBILITY POLICY

Purpose

Policy

Procedure

Advance Beneficiary Notice of Noncoverage (ABN)

WHAT YOU NEED TO DO NOW: