Frequently Asked Questions

Unfortunately, no. We are not contracted with any insurance companies at this time. This test is designed so that your patient does the finger prick at home. However, Intelligent Solutions DX tests are typically priced lower than out-of-pocket costs than the large reference Laboratories, who also do not accept insurance for these tests.

Due to the vast variety of insurance policies, companies, etc., the best way to determine whether or not a test is covered by your insurance provider is to contact them directly and discuss coverage. This is great advice for all medical procedures, as many consumers are hit with unexpected bills months after receiving care. With Intelligent Solutions DX, you know the exact price, with no hidden fees or mystery bills.

Typically, our test pricing is less than the out-of-pocket costs of testing in a large lab clinical setting. Additionally, there is a chance that any test may be covered partially by insurance but in most cases, at-home tests are not covered by insurance.

Unfortunately, we cannot. Your own coverage is unique to you, and it is best that you reach out to your insurance carrier directly if you’d like to learn more about your options.

Below you will find contact information for some of the major insurance companies. You can typically find a contact number on the back of your insurance card. We encourage you to contact your insurance carrier directly to learn more about your coverage.

• · Humana: 1-866-427-7478

• · Aetna: 1-800-872-3862

• · Blue Cross Blue Shield (BCBS): 1-800-521-2227

• · United Healthcare: 1-866-414-1959

• · Cigna: 1-800-997-1654

• · CMS (Medicare / Medicaid): 1-800-633-4227

Not that we’re aware of but we’d love to learn about one if you find it! Most tools for checking insurance coverage are insurance-operated and apply specifically to physician-ordered tests. As mentioned above, the absolute best way to check on your own coverage is to call or email your insurance company directly to discuss your personal options.

Generally speaking, yes, your patients can use their HSA/FSA account to pay for an at-home health test. Your Intelligent Solutions DX test is authorized by a physician, so it should fit the guidelines for most HSA/FSA coverage. If you have a particularly rigorous plan, it is best to check with your own plan if you’d like to verify before purchase.

Medicaid often does not cover health tests like these, and in these cases, our prices are typically lower than out-of-pocket costs for similar tests taken within a clinical lab environment.

Laboratory regulations require that all of our Tests be ordered by a Healthcare Provider. If you are interested in finding a Physician in your area that offers our testing, please reach out to us at hello@is-dx.com

Yes, we can! We will ship to any patient within the USA at no additional charge. You can dropship a kit directly through our portal. If your patient resides outside the USA, shipping charges to the patient will apply. You will need to contact us for estimated shipping charges.

Rapid, accurate results are our #1 priority. Turnaround time varies from 7 – 21 business days for most tests ordered. Upon occasion, turnaround time may extend due to supply chain interruptions or other temporary delays.

IS382 COMPLETE, Antigen Testing

Steroids should be discontinued 72 hours before testing

Some examples of steroids include:

• · triamcinolone

• · cortisone

• · prednisone

• · methylprednisolone.

Intestinal Barrier Assessment:

1. Zonulin- No interactions

2. LPS Antibiotics will not affect the test, but better to finish a course of antibiotics first to see how it alters LPS response. If patient is on long term on-going antibiotics, can be done at same time, but expect that LPS immune response would be higher if not on antibiotics

3. Histamine

4. No Interactions

5. DAO

• Tagamet and SSRIs will lower DAO

Adrenal Stress Test

Avoid Steroids for 72 hours

Do not take DHEA on the morning of test

Thyroid profile

Do not take thyroid medications on morning of test

Comprehensive Stool X Parasitology or GI360™

Discontinue Two Weeks prior to testing:

Antibiotics, antiparasitics, antifungals, probiotic supplements, proton pump inhibitors (PPIs), & Bismuth

Discontinue Two Days prior to testing:

Aspirin and other NSAIDs, digestive enzymes, laxatives (particularly mineral oil, castor oil, & glycerin enemas/suppositories), activated charcoal, betaine HCl, antacids or bentonite clay

Oxidative Stress Test

No medication interactions

The immune system is more mature by 9 or 12 months, but if for example, if there is a baby who is having terrible eczema, or gut pain, or other issues that you think are food-related, if the symptoms are bad enough, you should still consider testing.

Every lab is required to develop its own reference ranges. For this reason, you should not expect ranges to be the same from lab to lab. We look at the values over the hundreds of thousands of specimens we have run and then look at distributions. In general, the top 5% is determined high, and then the next 25% is moderate, and then the next 25% is lower. However, when there is epidemiologic evidence that the population, in general, has more difficulty with a food, such as wheat or dairy, we will consider % reactivity in populations in general, and consider research and data, alongside our distributions to create a range.

Intelligent Solutions DX cannot accept business from New York State. We do accept all other states as well as international business. For more information on International ordering contact international@is-dx.com

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. Your Rights You have the right to:

• Get a copy of your paper or electronic medical record

• Correct your paper or electronic medical record

• Request confidential communication • Ask us to limit the information we share • Get a list of those with whom we’ve shared your information

• Get a copy of this privacy notice

• Choose someone to act for you

• File a complaint if you believe your privacy rights have been violated Our Uses and Disclosures We may use and share your information as we:

• Treat you

• Run our organization

• Bill for your services

• Help with public health and safety issues

• Comply with the law

• Address workers’ compensation, law enforcement, and other government requests

• Respond to lawsuits and legal actions Your Rights When it comes to your health Information, you have certain rights. This section explains your rights and some of our responsibilities to help you. Get an electronic or paper copy of your medical record

• You can ask to see or get an electronic or paper copy of your medical record and other health information we have about you. Ask us how to do this.

• We will provide a copy or a summary of your health information, usually within 30 days of your request. We may charge a reasonable, cost-based fee.

• You can ask us to correct health information about you that you think is incorrect or incomplete. Ask us how to do this.

• We may say “no” to your request, but we’ll tell you why in writing within 60 days. Request confidential communications

• You can ask us to contact you in a specific way (for example, home or office phone) or to send mail to a different address.

• We will say “yes” to all reasonable requests. Ask us to limit what we use or share • You can ask us not to use or share certain health information for treatment, payment, or our operations. We are not required to agree to your request, and we may say “no” if it would affect your care.

• If you pay for a service or health care item out-of-pocket in full, you can ask us not to share that information for the purpose of payment or our operations with your health insurer. We will say “yes” unless a law requires us to share that information. Get a list of those with whom we’ve shared information

• You can ask for a list (accounting) of the times we’ve shared your health information for two years prior to the date you ask, who we shared it with, and why.

• We will include all the disclosures except for those about treatment, payment, and health care operations, and certain other disclosures (such as any you asked us to make). We’ll provide one accounting a year for free but will charge a reasonable, cost-based fee if you ask for another one within 12 months. Get a copy of this privacy notice You can ask for a paper copy of this notice at any time, even if you have agreed to receive the notice electronically. We will provide you with a paper copy. Choose someone to act for you • If you have given someone medical power of attorney or if someone is your legal guardian, that person can exercise your rights and make choices about your health information. • We will make sure the person has this authority and can act for you before we take any action. File a complaint if you feel your rights are violated

• You can complain if you feel we have violated your rights by contacting us using the information on page 1.

• You can file a complaint with the U.S. Department of Health and Human Services Office for Civil Rights by sending a letter to 200 Independence Avenue, S.W., Washington, D.C. 20201, calling 1-877-696-6775, or visiting www.hhs.gov/ocr/privacy/hipaa/complaints. Our Uses and Disclosures How do we typically use or share your health information? We typically use or share your health information in the following ways. Treat you We can use your health information and share it with other professionals who are treating you. Run our organization We can use and share your health information to run our practice, improve your care, and contact you when necessary. Bill for your services We can use and share your health information to bill and get payment from health plans or other entities. How else can we use or share your health information? We are allowed or required to share your information in other ways – usually in ways that contribute to the public good, such as public health and research. We have to meet many conditions in the law before we can share your information for these purposes. For more information see: www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/index.html. Help with public health and safety issues We can share health information about you for certain situations such as:

• Preventing disease

• Helping with product recalls

• Reporting suspected abuse, neglect, or domestic violence

• Preventing or reducing a serious threat to anyone’s health or safety Comply with the law We will share information about you if state or federal laws require it, including with the Department of Health and Human Services if it wants to see that we’re complying with federal privacy law. Address workers’ compensation, law enforcement, and other government requests We can use or share health information about you:

• For workers’ compensation claims Intelligent Solutions DX, LLC P.O. Box 555, Leander, TX 48646 800-xxx-xxxx www.is-dx.com For law enforcement purposes or with a law enforcement official. With health oversight agencies for activities authorized by law. For special government functions such as military, national security, and presidential protective services Respond to lawsuits and legal actions We can share health information about you in response to a court or administrative order, or in response to a subpoena. Our Responsibilities

• We are required by law to maintain the privacy and security of your protected health information. • We will let you know promptly if a breach occurs that may have compromised the privacy or security of your information.

• We must follow the duties and privacy practices described in this notice and give you a copy of it. • We will not use or share your information other than as described here unless you tell us we can in writing. If you tell us we can, you may change your mind at any time. Let us know in writing if you change your mind. Changes to the Terms of this Notice We can change the terms of this notice, and the changes will apply to all information we have about you. The new notice will be available upon request, in our office, and on our web site.

The IS382 COMPLETE Food Sensitivity, Allergy and Tolerance Test is a Laboratory Developed Test (LDT) and falls under the federal Clinical Laboratory Improvement Amendments (CLIA), guidelines for precision, accuracy, reproducibility, and linearity. There are an estimated 11,000 labs offering as many as 100,000 LDTs in the US, and LDTs are performed by most laboratories in the US. Those studies are all considered proprietary to the laboratory, so they are not published in the general public marketplace. The materials, methods, analysis process, and particularly the proprietary algorithm, are all proprietary technologies, so there is little any Lab is willing to share. Basically, the Lab figured out how to make all of the IgE, IgG, IgG4 and the C3d Complement Factor tests talk to each other, and they are protecting their proprietary knowledge and processes.

That being said, the four immune markers (IgE, IgG, IgG4 and the C3d Complement Factor) that are evaluated, have been utilized in the laboratory industry for many years, and the immunoassay instruments used in the lab are commonplace. There are journal articles on the subject of food allergy and sensitivity testing using: IgE, IgG, IgG4, and the C3d Complement Factor; however, none of those articles are specific to The IS382 COMPLETE proprietary test and technology.

The IS382 COMPLETE Food Sensitivity, Allergy and Tolerance Test is very specific to the food antigen itself. The antigens tested in the analyzer are from the actual food, and the immune reactions are measured in reference ranges relative to each antigen.

There are blood tests for pesticide exposure available. If you suspect the patient has pesticide poisoning, a Cholinesterase test will help evaluate that. Overexposure to organophosphates is on the rise, to be certain.