Informed Consent

Informed Consent

Repetitive Transcranial Magnetic Stimulation (rTMS)

Introduction

Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of applying magnetic stimulation to the brain for therapeutic benefits. The U.S. Food and Drug Administration (FDA) has cleared certain devices that deliver rTMS for use in adults with major depressive disorder (MDD) who have failed to receive satisfactory improvement from antidepressant medications.

Alyne Wellness uses a personalized version of rTMS that we call PrTMS® for treatment of various conditions (not just MDD), using treatment plans that are tailored based on each individual’s medical assessment. rTMS is delivered to patients based on these personalized treatment plans.

PrTMS has not been reviewed or approved by the U.S. FDA, and there have not been clinical studies evaluating the safety or effectiveness of the PrTMS therapy. Alyne Wellness is offering PrTMS to you based on our clinicians’ expertise, experience, and medical judgment, which leads us to believe that you may benefit from such treatment. However, there is no guarantee that you will benefit from receiving rTMS following our PrTMS protocol.

Approach

During a PrTMS session, you will be led to a treatment room and seated in a comfortable chair in a slightly reclined position. A member of the care team will place an electromagnetic coil softly against your head. The coil painlessly delivers a magnetic pulse that stimulates nerve cells (neurons) at pre-determined intervals over the course of a session of approximately thirty minutes. Your medical provider determines the exact treatment protocol for you based on the results of your initial medical assessment, which will have included discussions of your current medical condition, medical history, results of neuro-cognitive tests and a quantitative electroencephalogram (EEG) of your brain waves. The device used to collect the EEG in our medical practice, the Cognionics Quick-20 wireless EEG device, has not been reviewed or approved for use by the FDA. Our PrTMS therapy typically consists of five, thirty-minute sessions per week for a course of six to eight weeks, but the exact course of treatment can vary on a patient-by-patient basis.

In general, PrTMS patients are re-evaluated after every five PrTMS treatments to determine whether adjustments are needed. Adjustments intended to improve response or safety for a patient are based in large part on the information we receive from you regarding your response to treatment. Therefore, to make our best medical judgments, it is important that you tell us how you are feeling, answer all of our questions honestly and to the best of your ability, as well as disclose all underlying medical conditions. We also need to be informed of any use of alcohol, prescribed medications, and any other drugs prior to beginning treatment. It is important that you update us if there are any changes to this information after your treatment begins.

Contraindications

You should generally not undergo rTMS if you have ferrous metals in your head, a history of bipolar disorder, schizotypal disorder, seizure disorder, and/or have been prescribed anti-psychotic medications in the past. You should inform your medical provider if you have any of these conditions.

Risks of rTMS

rTMS is a noninvasive form of brain stimulation used for depression. It is also used off-label for the treatment of conditions other than depression. Unlike vagus nerve stimulation or deep brain stimulation, rTMS does not require surgery or implantation of electrodes. And, unlike electroconvulsive therapy (ECT), rTMS rarely causes seizures or requires sedation with anesthesia. Generally, rTMS is considered safe and well-tolerated. However, it can cause some side effects.

Common Side Effects

Common side effects may include headache, scalp discomfort at the site of stimulation, and lightheadedness. If there are side effects, they are generally mild to moderate and improve shortly after an individual session and decrease over time with additional sessions. In addition, hypoglycemia has been noted in some patients, and therefore we suggest 20-30 grams of simple carbohydrate taken 20-30 minutes prior to daily rTMS treatments and prior to every qEEG.

Uncommon Side Effects

Serious side effects are rare. These may include seizures, mania, or other psychosis particularly in people with bipolar disorder. Substance abuse during treatment may also impact response and side effects during treatment. Thus, it is important to tell us about all the drugs you are using, whether prescribed or not.

Further research is needed to determine whether rTMS may have any long-term side effects. Moreover, the effective number of treatments and the duration of an effective treatment plan are unknown. Most of our experience with PrTMS involves treatment programs that include about 30-40 treatments over the course of 6-8 weeks. Patients receiving more frequent treatments over the same time period, or a larger number of total treatments, might be at higher risk for serious side effects.

Risks of EEG Testing

There is a possibility that the Cognionics Quick-20 wireless EEG device will not function as intended, which could result in inaccurate EEG results. Although physical harm from such a malfunction is unlikely, inaccurate EEG results could impact the effectiveness of your personal rTMS treatment protocol.

Benefits

There is no guarantee that you will receive benefits from PrTMS. However, our practice has observed that PrTMS may help improve quality of sleep, lower stress, and improve mood and quality of life for patients with various underlying conditions.

Other Uses of Health Information

PrTMS will be provided to you solely for your medical care. However, information from your treatment experiences may teach us more about how to improve PrTMS. At some time in the future, we may decide to use or share de-identified information about your treatment experiences to further improve PrTMS or otherwise support research and development. “De-identified” means any such uses or disclosures will not reveal who you are. Your attending medical provider remains responsible for your care at all times.

Mental Health Provider and Medication Management

I understand that at Alyne Wellness, Abe Malkin, M.D. is not my mental health provider. Alyne Wellness does not provide any medication management or advise on any prescription alterations. I will continue to see my primary care provider, psychiatrist, or any other doctor of record, for all medication management. I have read and understand this statement.

Patient Consent to PrTMS Therapy

I understand that I should feel free to ask questions of my medical provider or member of the care team about PrTMS at this time or any time during or after the course of my treatment. I understand that my decision to receive PrTMS therapy is being made on a voluntary basis and that I may withdraw my consent and have the therapy terminated at any time.

I understand that there are alternative treatment options for my condition, which may include medications, psychotherapy, electroconvulsive therapy, or other therapies. My medical provider has explained to me why he or she believes PrTMS may be helpful for my specific case.

I have read (or have had read to me) the information contained in this consent form about PrTMS therapy and its potential risks and benefits for the treatment of my diagnosis.

I understand that there have not been clinical studies evaluating the safety or effectiveness of PrTMS therapy. My medical provider has explained to me the risks and benefits of PrTMS therapy, as well as the other treatment options available to me for my condition. All questions regarding therapy were answered to my satisfaction. If during the course of treatment other conditions arise which, in the best judgment of the care team, require emergency treatment, I authorize and request that said treatment be performed. I understand that results will vary by patient and that no guarantee, warranty, or assurance of any results that may be obtained from PrTMS therapy or promise of cure, amelioration, or remission of any disease or condition has been made to me either verbally or in writing. I further understand that all payments for treatment are final, and no refunds will be given for treatments received.

I consent to the PrTMS treatment and related procedures, and I authorize and request that my medical provider and care team administer a course of PrTMS therapy to me. I understand that photographs, videotapes, digital and other images may be recorded to document my care and I consent to this, too. I understand that these images will be stored in a secure manner that will protect my privacy, and that they will be kept for the time period required by law.

I understand it is important that I tell my care team at Alyne Wellness how I am feeling, answer any questions they ask honestly and to the best of my ability, and disclose all underlying medical conditions, as well as the use of alcohol, prescribed medications and any other drugs prior to beginning treatment. I also understand I need to update my Alyne Wellness care team if there are any changes while I am a patient at Alyne Wellness.

I have read (or have had read to me) this Informed Consent, which is printed in English. This is a language that I can read and understand.

I also acknowledge being provided with a copy of the Alyne Wellness Notice of Privacy Practices (HIPAA).

Alyne Wellness, P.C. Patient Financial Responsibility/Assignment of Benefits

Thank you for choosing Alyne Wellness, P.C. as your healthcare provider. We ask that you read and sign this form to acknowledge your understanding of Alyne Wellness patient financial responsibility policies. If another person (parent, guardian, spouse, domestic partner, etc.) is financially responsible for your medical expenses or carries your insurance, please share this form with them (the “Responsible Party“). If you have any questions regarding your financial responsibility, please refer to the contact information at the bottom of this form.

By submitting my information and/or by receiving medical services from Alyne Wellness, you agree to the following:

Patient Financial Responsibility.

You understand that you are ultimately responsible for all payment obligations arising out of your treatment or care and guarantee payment for these services. You are responsible for deductibles, co-payments (due at time of service), co-insurance amounts, or any other patient responsibility indicated by your insurance carrier, your plan benefits (“Plan“), or payment obligations which are not otherwise covered by your Plan.
Although claims may be filed with your insurance carrier as a benefit to you, claim adjudication is done by your insurance carrier and processed according to your Plan. If you have any questions or concerns regarding how your claim was processed, please contact your insurance carrier directly regarding your Plan.
You are responsible for knowing your Plan benefits. If a referral and/or prior authorization is required, you must obtain it prior to your visit.
You are responsible for notifying Alyne Wellness as soon as possible regarding any changes related to your insurance coverage.
In the event your insurance carrier determines services received are not payable, you will be responsible for all charges and agree to pay all costs of services provided.
If you are uninsured or choose to pay cash for your treatment/care, you agree to pay all charges for medical services prior to, or at the time, services are rendered.
The parent/guardian of a minor or a person identified as an authorized power of attorney for an individual’s treatment/care is responsible for payment of the account balance and must sign this form.
You authorize Alyne Wellness to communicate by mail, phone (landline or cell), text, and/or email for purposes related to your account, including collections for a debt. Should collection proceedings/legal action be necessary to collect on a delinquent account you understand that Alyne Wellness may disclose to an outside agency/attorney all relevant personal and account information needed to collect a debt and you accept responsibility for the incurred costs/fees of such services.

[Alyne Wellness does not bill Workers’ Compensation ]¹

Alyne Wellness accepts the following payment methods: cash, check, debit card, or credit ²

In accordance with Alyne Wellness’s policies, you may incur, and will be responsible for additional charges, such as charges for failing to provide 24 hours’ notice for cancelled appointment and charges for returned checks.

Insurance Authorization/Assignment of Benefit.

By submitting your intake form, you authorize assignment of your Plan financial benefits directly to Alyne Wellness for services rendered, and you agree you remain financially responsible for all Alyne Wellness charges not covered by this assignment.
You agree to immediately turn over to Alyne Wellness any payments or fees received by you directly from your Plan for services provided by Alyne Wellness and to indemnify Alyne Wellness for all costs, fees, charges, and expenses, including reasonable attorney fees, incurred by Alyne Wellness as a result of your failure to turn over such payments.

For questions regarding patient financial responsibility, please contact:

Kelly Sarac at 1(818) 839-7556

By submitting your intake form, you agree that you have read, understand, and agree to the terms/conditions within this document and that these terms/conditions are in full force and effect.

ALYNE WELLNESS, P.C.

HIPAA NOTICE OF PRIVACY PRACTICES

THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.

WHO WILL FOLLOW THIS NOTICE

This Notice of Privacy Practices (the “Notice”) describes Alyne Wellness, P.C., (“we” and “our”) practices and those of our employees, staff, volunteers, and other personnel who are involved in the provision of services to you. We and these individuals will follow the terms of this Notice, and may use or disclose medical information about you to carry out treatment, payment, or health care operations, or for other purposes as permitted or required by law. This Notice describes your rights to access and control medical information about you, including information that may identify you and that relates to your past, present, or future physical, medical, or mental condition and medical care and related health care services.

OUR PLEDGE REGARDING MEDICAL INFORMATION

We understand that medical information about you and your health is personal. We are committed to protecting medical information about you. In order to provide you with quality care and to comply with certain state and federal legal requirements, we create a record of the services you receive from us. This Notice applies to all of the records of your care generated or maintained by us. This Notice will tell you about the ways in which we may use and disclose medical information about you. It also describes your rights and certain obligations we have regarding the use and disclosure of medical information. We are required by law to: (1) make sure that medical information that identifies you is kept private; (2) give you this Notice of its legal duties and privacy practices concerning medical information about you; (3) follow the terms of the Notice that are currently in effect, and (4) notify you in case there is an unauthorized use or disclosure of your unsecured medical information.

A WORD ABOUT FEDERAL AND STATE LAW

Federal and state laws both have rules and regulations regarding the protection of your health information. When state law and federal law differ, federal law requires that providers comply with the federal or state law that provides you with greater protection.

HOW WE MAY USE AND DISCLOSE MEDICAL INFORMATION ABOUT YOU

The following categories describe different ways that we may use or disclose protected medical information. For each category of uses and disclosures, we will explain what is meant and may give some examples. Not every use or disclosure in a category will be listed. However, all of the ways we are permitted to use and disclose information will fall within one of the categories. Some information such as psychotherapy notes, certain drug and alcohol information, HIV, or mental health information is entitled to special restrictions.

For Treatment. We may use medical information about you to provide you with medical treatment and to coordinate or manage your medical treatment and any related services. We may disclose information about you to our staff or other providers involved in your treatment. We may also disclose your medical information to family members or other individuals involved in your continuing medical care after you leave us. For example, we may share your protected health information between or among our personnel to assist your health care providers in treating you.

For Payment. To the extent applicable, we may use and disclose medical information about you so that we can get paid for the treatment and services you receive from us. For example, we may need to give information to your health plan or to the Medicaid or Medicare program about treatment you receive from us so that they will pay us or reimburse you for your care. We may also tell your health plan about a proposed treatment to determine whether your plan will cover the treatment.

For Health Care Operations. To the extent applicable, we may use and disclose medical information about you to carry out activities that are necessary for our operations. These uses or disclosures are made for quality of care, compliance activities, administrative purposes, contractual obligations, grievances, or lawsuits. For example, we may use medical information to review treatment and services provided by us or to evaluate the performance of our staff and contractors in caring for you.

To Individuals or Family Members Involved in Your Health Care. Unless you object, we may disclose medical information about you to a member of your family, a relative, close friend or any other person that you identify who is involved in your care. We may also tell your family or friends, personal representative, or any other person who is responsible for your care, of your location, general condition or death, unless you object.

For Appointment Reminders. We reserve the right to contact you, in a manner permitted by law, with appointment reminders or information about treatment alternatives and other health related benefits that may be appropriate for you.

Emergencies. We may disclose medical information about you to a public or private entity assisting in disaster relief so that your family can be notified about your condition, status, or location. You may object to this disclosure with a written request. However, if you are not available or are unable to agree or object, or in some emergency circumstances, we will use our professional judgment to decide whether this disclosure is in your best interest.

If you would like to object to this disclosure please contact us.

For Fundraising Activities. We may use medical information about you to contact you about our sponsored activities including fundraising events. We will only use contact information such as your name, address, and phone number.

As Required by Law. We will disclose your health information when required to do so by federal, state, or local law enforcement.

Workers’ Compensation. We may release medical information about you for workers’ compensation or similar programs. These programs provide benefits for work-related injuries or illness.

For Public Health Activities. We may disclose medical information about you for public health activities. These purposes generally include the following: (1) to prevent or control disease, injury, or disability; (2) to report deaths; (3) to report abuse or neglect of children, elders, and dependent adults; (4) to report reactions to medications or problems with products; (5) to notify people of recalls of products they may be using; and (6) to notify a person who may have been exposed to a disease or who may be at risk for contracting or spreading a disease or condition.

For Health Oversight Activities. We may disclose medical information about you to a health oversight agency for activities authorized by law.

For Lawsuits and Disputes. We may disclose medical information about you in response to a court or administrative order, subpoena, discovery request, or other lawful process.

Disclosure to Law Enforcement. If asked to do so by law enforcement and as authorized, or required by law, we may release medical information: (1) to identify or locate a suspect, fugitive, material witness, or missing person; (2) about a suspected victim of a crime if, under certain limited circumstances, we are unable to obtain the person’s agreement; (3) about a death suspected to be the result of criminal conduct; (4) about criminal conduct; and (5) in case of a medical emergency, to report a crime, the location of the crime or victims, or the identity, description or location of the person who committed the crime.

Decedents. We may release medical information about you to a coroner or medical examiner. This may be necessary, for example, to identify a deceased person or determine the cause of death. We may also release medical information about you to funeral directors. We may also release information to any individual known to us as a family member, close personal friend of the family, or any other person identified, who was involved in your care or the payment for your care prior to your death, unless you indicate otherwise. Your medical information may be used or disclosed to others without your authorization after fifty (50) years from the date of your death.

For Specialized Government Functions. We may disclose medical information about you to authorized federal officials for intelligence, counter intelligence, and other national security activities.

Information About Inmates/Individuals in Custody. If you are an inmate or under the custody of a law enforcement official, we may release medical information about you to the correctional institution or law enforcement official responsible for you as authorized or required by law.

Disclosure For Threats to Health and Safety. In certain circumstances, we may be required to disclose medical information to avert a serious threat to your health and safety or the health and safety of another person as required by law enforcement. The use or disclosure will be made in compliance with the law and will be limited to the relevant requirements of the law.

SPECIAL PROVISIONS RELATED TO MEMBER PRIVACY

Psychotherapy Notes. We will not release any psychotherapy notes without a specific authorization from you that allows us to release the notes.

Marketing. We will not release your medical information for marketing purposes without an authorization from you.

Sale of Medical Information. We will not sell your medical information without an authorization from you.

HIV/AIDS Test Results. We will not disclose the results of an HIV/AIDS test unless you give us specific written authorization. We may disclose HIV/AIDS test results without your specific authorization as required by state or federal reporting laws.

YOUR RIGHTS

You have the following rights regarding your medical information. In order to exercise these rights, you must contact our HIPAA Privacy Officer. You may be asked to submit a written request. The HIPAA Privacy Officer may be contacted using the following information:

Alyne Wellness, P.C.
Attn: Privacy Officer
27489 Agoura Road, #101
Agoura Hills, CA 91301

info@Alynewellness.com

Right to Inspect and Copy. With certain exceptions, you have the right to inspect and receive copies of your medical information.

Amendment. If you feel that medical information about you is incorrect or incomplete, you may ask us to amend the information.

Right to an Accounting of Disclosures. You have the right to receive a list of certain disclosures that we may have made of your medical information.

Right to Request Restrictions. You have the right to request a restriction or limitation on medical information that we use or disclose about you for treatment, payment, or health care operations, and to request a limit on the medical information that we may disclose to family members or friends involved in your care.

Request Confidential Communications. You have the right to request that we communicate with you about your appointments or other matters related to your treatment in a specific way or at a specific location.

Receive a Copy. You have the right to obtain a copy of this notice.

CHANGES TO THIS NOTICE

We reserve the right to change the terms of this Notice at any time. We reserve the right to make the revised or changed notice effective for medical information we already have about you as well as any we receive in the future. We will post a copy of the current Notice. The Notice will contain an effective date.

QUESTIONS AND COMPLAINTS

If you have any questions or believe that your privacy rights have been violated, you may contact our HIPAA Privacy Officer in person or mail a written summary of your concern to the address listed above.

You may also file a complaint with the Department of Health and Human Services as follows:

Centralized Case Management Operations

U.S. Department of Health and Human Services

200 Independence Avenue, S.W.
Room 509F HHH Bldg.
Washington, D.C. 20201

Customer Response Center: (800) 368-1019

Email: OCRPrivacy@hhs.gov

OTHER USES OF MEDICAL INFORMATION

Other uses and disclosures of medical information not covered by this Notice or the laws that apply to use will be made only with your written permission. If you provide us permission to use or disclose medical information about you, you may revoke that permission in writing at any time. If you revoke your permission we will stop any further use or disclosure of your medical information for the purposes covered by your written authorization, except if we have already acted in reliance on your permission. You understand that we are unable to take back any disclosure we have already made with your permission and that we are required to retain its records of the care that we provided to you.

ACKNOWLEDGMENT OF RECEIPT

By submitting your intake form you acknowledge that you have received the HIPAA Notice of Privacy Practices of Brainlab Medical, P.C.