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THE FUNDAMENTALS
BrainSpan is about empowering individuals to achieve their biological health potential in ways that are simple yet highly effective and will permeate the physical, emotional, social, and occupational (or academic) dimensions of one’s life. This enhances the quality of one’s life in addition to optimizing the process and outcomes of specific life stages that include: childhood neurodevelopment, pregnancy and fertility, and the aging process as a whole. Lastly, there are also implications for optimizing our immune response to a variety of pathogens that threaten individuals and communities as a whole. This is through the direct benefit of improving the quality, strength and long-term resilience of our cellular immune response.
The focus of our assessment is in specific and actionable biological parameters that comprise the structure and function of our individual cells of which we are composed. Using nutritional markers that are objective and well validated to correlate with health outcomes, we apply the lens of functional significance. This enables one to see how the nutritional, lifestyle and day to day choices we make are extremely relevant to us in the here and now; in addition to their relevance as it pertains to the risk of future negative health events. When this is done properly, the health information we measure, which is central to the biological truth of how we are made structurally, becomes something of much more functional relevance to us today. This in turns makes the data much more meaningful and actionable when it comes to producing not just an initial decision to change, but a long term goal of staying with it.
The BrainSpan Genesis-14 Test System
A total of 14 metrics are delivered in the Genesis-14 kits, the current kit produced by BrainSpan. These 14 metrics include the following:
The computed scores are calculated from customized BrainSpan algorithms that leverage published peer reviewed science to weight various factors. The algorithms calculate scores based on the integration of the 7 biological markers as well as several other secondary markers and demographics that have much more clinical utility if they are computed with consideration of the meaning of other well known markers.
The Fatty Acid Panel: The Biological Basis for Life
A total of 32 cellular fatty acid metrics are ran from each blood spot sample to get a true "3-D" view of the cell structural health. BrainSpan is a unique fatty acid test in that it actually is measuring the cellular fatty acid levels which have far greater significance than total circulating levels that fluctuate day to day based on recent dietary intake alone.
The primary fatty acids that each have individual scores and full interpretation and recommendation within the BrainSpan report are listed below. BrainSpan considers these 3 markers to be the most critical for overall cell structural health.
Primary Blood and Functional Markers
Secondary fatty acids used for both validation and computed scores.
The Cognitive Function Metrics
The cognitive metrics that are measured with a well validated test that has been used in more than 450 peer reviewed publications are listed below. Please see the article on reliability and validity of the cognitive function test for more detailed information about this scoring tool. The four domains of function are shown below and what testing method is used.
Other Scores Using Computational Biology
The BrainSpan Index
This is perhaps one of the most important metrics of all due to its ability to create patient engagement. The primary goal is to encourage patients to more strongly consider how the day to day decisions they make have a large cumulative affect on their quality of life tomorrow. This effect can and usually increases over time (increased negative effect on the predicted functional capacity) as the resilience capacity of the cell also declines with age. Worsening the effect is the increased exposure of cells overtime to often poor or even harmful levels of dietary macronutrients. Of course now, especially when one considers what is at risk with respect to cognitive capacity and quality of life, the data becomes extremely actionable.
The BrainSpan Index thus is a reflection into the future based on the quality of cell to cell function today and the projected cellular micro-environment of the future and the degree of exposure time based on their current age. This is a great way to bring quality of life discussions and brain health to the forefront and their relevance to dietary and nutritional decisions made every day now in ways that resonate with patients that simple disease risk calculations simply do not do.
The below graphic illustrates the importance of the BrainSpan metric as the only one, true, and validated metric that integrates day to day lifestyle and dietary decisions with their impact on our future quality of life.
Picture A. The Concept of the BrainSpan Index
Using over 33 validated research publications, knowing your brainspan number as you know your own height and weight helps individuals see their daily habits through a new lens that places them at the very forefront of influencers with respect to our ability to reach our potential and optimize our human performance and quality of life. When our nutritional habits convey their importance as direct determinants of our body and brain functional well-being as well as our resilience to aging, degeneration, and various disease processes, the role of being an engaged and informed participant and patient becomes vitally apparent.
The candidates for the BrainSpan Assessment can be thought of us as two groups: clinical disease management and clinical prevention/health optimization applications. Within each of these major categories, we can provide a framework for applications of the test:
Clinical Prevention/Health Optimization Applications
BrainSpan should be considered by any practitioner their first line wellness diagnostic test system. These vital signs of cellular well being come from integrating two distinct tests into one for the purpose of providing detailed information on total cell health and thus total human well-being and resilience to disease and aging. Cells, which comprise the most fundamental unit of life, and their health markers are the most fundamental of all well-being information.
Recommendations of how to improve them are largely based on evidence based nutritional and lifestyle recommendations. Structure-function relationships in biology are the foundation. Yet our application of structure-function approaches to well-being at the most important and fundamental level of life itself are largely ignored. This neglect can both contribute to the worsening of chronic disease and organ inflammation as well as be the independent major contributor through metabolic or inflammatory pathways. Loss of resistance to aging, and increased risk of premature cognitive decline and physical function with age result when these fundamentals are ignored.
Age/Lifestage by Age Groups
Lifestage Benefits
Clinical Disease Management:
The BrainSpan Assessment can be used in the management of the following conditions, clinical syndromes or diseases as a way to first ensure that the underlying cellular health is properly addressed:
The cognitive test normative database relies on a specific age range of subjects that the patient must fall within for the results to be most accurate. These age ranges are 6 to 92 years of age. However, because of the BrainSpan report requiring at least an 8th grade reading level or above, we do not recommend the cognitive test in children less than age 14. If the patient falls outside one of the limits of the database (6 to 92), they will still receive a score, but the scoring algorithm will default to the next closest age group in the database to score the patient against.
In practical use, BrainSpan recommends focusing on optimization of the fatty acid levels from infancy through age 26; due to the level of neurogenesis within this age group and the importance of optimal fatty acids, especially DHA and EPA during this time frame. The cognitive test clinical utility in our experience is best seen with those age 40 and older. It is important to note that the cognitive test results are providing information that strictly provides insight into how the scoring performance of the patient compares to what would be expected for someone their age and gender and educational status who is part of a very well controlled, healthy group and that which represents our best attempt at identifying "normal" brain function. It is a not a diagnostic for any specific disease.
That said, it is this use that we believe increases the clinical utility and interest to a broader group of people looking to optimize their brain function and in a sense, build their own data set of normal cognitive function over time--which would later serve as a sensitive indicator to abnormal findings whereas a diagnostic test may indicate nothing is of concern.
The recommended re-testing strategy based on several well done studies and BrainSpan's own internal analysis published in the form of 3 technical reports indicates that the ideal re-testing strategy that serves to both drive patient adherence as well as provide important dose or treatment modification adjustment opportunities is the following:
This serves six important purposes:
The cognitive function test is ran strictly by access to the world wide web with at least a 3G equivalent connection or greater. There is no software to download. The tests used and the areas of the brain tested are shown in the graphics below.
BrainSpan's Fatty Acid Testing Methodology
BrainSpan’s methodology for the blood biomarker testing is the most clinically validated method available on the market today and is based on decades of research from leading journals and institutions around the world some of which are shown below. This precise method and the same lab used today by BrainSpan was chosen by the US Army for example, when studying the role of fatty acids in contributing to performance and cognitive function in combat in 2011. BrainSpan utilizes a method called "RBC method" for how the fatty acids are measured. This technique is rarely used by most of the larger labs in the United States but is by far the most clinically relevant and the most evidence based. To date, there are over 160 peer reviewed studies on fatty acid levels and clinical outcomes and over 95% of these rely on the RBC method.
This method does not require the patient to be fasting, is considerably more reliable and stable from plasma fatty acids or other techniques that include plasma levels, and has far more clinical relevance as it pertains to health and health outcomes.
Science Behind the Finger stick Dried Blood Spot Fatty Acid Test
BrainSpan’s methodology for the blood biomarker testing is the most clinically validated method available on the market today and is based on decades of research from leading journals and institutions around the world some of which are shown below. This precise method and the same lab used today by BrainSpan was chosen by the US Army for example, when studying the role of fatty acids in contributing to performance and cognitive function in combat in 2011. BrainSpan utilizes a method called "RBC method" for how the fatty acids are measured. This technique is rarely used by most of the larger labs in the United States but is by far the most clinically relevant and the most evidence based. To date, there are over 160 peer reviewed studies on fatty acid levels and clinical outcomes and over 95% of these rely on the RBC method. This method does not require the patient to be fasting, is considerably more reliable and stable from plasma fatty acids or other techniques that include plasma levels, and has far more clinical relevance as it pertains to health and health outcomes.
Science Behind the Cognitive Test
BrainSpan’s cognitive function test is one with a fascinating background and there are specific reasons why it was chosen for this wellness instrument. The cognitive function test is not a disease diagnostic but rather an excellent barometer to understand how one's performance compares to what is expected based on a very well studied group of controls across many age groups that serve as the normative database to which the performance of the patient is compared against.
The test was born out of a non-profit corporation called the Brain Resource International Database® headed by the esteemed Dr. Evian Gordon and contributed to by over 350 scientists around the world, many leaders in the neuro-cognitive clinical, research and academic space. Funded with over 10 million dollars by big pharmaceutical companies who were looking for a tool that could rapidly screen people in or out of clinical trials for long term drug studies, the test was used as an accurate way to detect what we can best identify as "normal" brain function in a specific age, gender and educational status of society. The database is the world’s largest standardized international database. The Brain Resource® methodology has provided the basis for over 450 peer-reviewed publications.
The Future is Extremely Bright for Omega-3s and Omega-3 Testing
First proposed for use in medical care about 15 years ago, the fatty acid panel, specifically the Omega-3 Index, is still a relatively new test from a medical standpoint. A new blood test usually takes about 30 years to be standardized and finally adopted by the medical community.
With the public (and your patient's) awareness of omega-3s being nearly universal these days, the increase in research funding and positive results from recent studies will only continue to fuel this very important nutritional category. And the BrainSpan Core Assessment will be along for the ride, as future studies make it a standard measure of health among subjects and correlate actual blood levels of omega-3s with health outcomes.
Some recent studies worth mentioning
In 2018 alone, several high profile studies strengthened the importance of omega-3s and the BrainSpan Core Omega-3 Index not only in heart health, but also in brain health and pregnancy. The most important takeaway from these studies is that retailers, consumers and health practitioners alike can all recommend with great confidence improving one's fatty acid status, especially the RBC level of EPA/DHA (or the Omega-3 Index) and if you do not measure, you simply do not know.
It all started in March with the publication of data from the Framingham Heart Study in the Journal of Clinical Lipidology, where omega-3 blood levels were shown to be a better predictor of death than serum cholesterol. Results showed that the risk for death from any cause was reduced by about 33% when comparing participants with the lowest Omega-3 Index to those with the highest Omega-3 Index. This test used the exact same validated methodology as the BrainSpan Core Assessment and also used a CLIAA certified lab.
Then in June a study published in Hypertension found a direct link between the Omega-3 Index and blood pressure. The researchers concluded that a higher Omega-3 Index was associated with statistically significant, clinically relevant lower blood pressure levels in healthy, young adults, and that diets rich in omega-3 fatty acids — specifically EPA and DHA — might be a strategy for preventing hypertension.
This is all great news that should further bolster your confidence in the role of fatty acid testing in your clinical practice; not to mention the importance of cognitive function testing which is touched on elsewhere.
Other Important Recent Studies
Finally, November witnessed the publication of three landmark studies on omega-3s — the REDUCE-IT and VITAL trials, as well as an updated Cochrane Review. REDUCE-IT was notable for being the highest dose omega-3 study looking at effects on risk for, in this case, cardiovascular disease, ever performed. VITAL stood out for being the largest and most ethnically diverse study with clinical endpoints. In short, REDUCE-IT found a 25% risk reduction in cardiovascular events, while VITAL found significant reductions in heart attacks (28%) and fatal heart attacks (50%).
The Cochrane Review looked at omega-3s and pregnancy and whether or not they represent an effective strategy for reducing risk for early preterm birth. The 70 randomized controlled trials (RCTs) the researchers analyzed in this updated review involved more than 20,000 women — showing that supplementation with omega-3s reduced the risk of having a baby before 37 weeks by 11% and before 34 weeks by 42%. The researchers went so far as to say that “more studies are not needed … to prove causality in relation to preterm birth.”
Additional Information: the Cochrane Study
As 2021 approaches, it is important to remember that getting your omega-3s from fish or supplements is critical... and frankly for most, fish alone is simply too expensive and too inconvenient. But everyone in the family should know their BrainSpan Index--this is the only way that you know you are taking enough of the right omega-3s —EPA and DHA — to achieve evidence based, health protective levels.
In the end, it is reassuring to know that a laboratory test like the BrainSpan Assessment is a covered health expense that is simple, safe and convenient.
Yes, BrainSpan is FDA cleared to be performed by the patient or a legal parent/guardian. The finger stick is a simple 4 step process that a patient can walk through on their own (using the test kit instructions on the sample card which can be shared with patients who are taking the test from home.) They then mail the sample card in from their place of residence/collection.
The cognitive test, as a web based assessment, can be provided to the patient via an email with an embedded link that is uniquely assigned to that kit code and patient; as long as the kit is registered correctly. There is nothing else needed except a compatible device, basic wifi internet connectivity, and the ability to read the instructions before each part of the test which are written at about the 4th-5th grade reading level. This permits any healthcare practitioner to provide BrainSpan to any client/patient.
TAKING THE ASSESSMENT
Everything you need to know about conducing an Assessment.
Method 1: The Portal Method
Method 2: The Website Method
Important Considerations of Registering Kits and Cognitive Testing Workflow
The process of using the website to register a kit is shown above. Note that kits registered on the website require the exact same information as the portal kit registration. The kits are auto-assigned into the account to which they belong as during order fulfillment, your kits are activated to your account. The process by which kits are registered (method 1 or 2 above) will shape the workflow for how you launch the cognitive test.
Implications for the Cognitive Test Email Automatic Delivery
The method used for kit registration will determine whether or not the cognitive test email with instructions is automatically sent.
Example of Cognitive Test Email
The email above is automatically sent when kits are registered on the website. Kits registered within the portal, will not automatically send the patient the email to take the cognitive test since the system assumes you may want to follow the workflow inside the portal. In this case, you would start the cognitive test by clicking the Start Now button and then handing the device or providing the mouse/keyboard to the patient when you see the test fill the screen as shown below:
Implications for Ease of Access to Cognitive Test Immediately after Kit Registration
When a kit is registered on the website, immediately following kit registration, the page will show a special button and link to take the cognitive test immediately at that time.
This can be a useful tool especially in cases where the efficiency of the workflow would be enhanced without the need to access an email for the instructions or to necessarily be logged into the portal. Therefore, consider using web based registration even if the patient is registering the kits from inside the clinic and not from afar. This could enhance your workflow efficiency and make it easier for staff to register kits and get the initial cognitive test done in a frictionless manner.
The BrainSpan Assessment takes approximately 3-4 minutes to complete the finger stick dried bloodspot collection and about 7-12 days to receive the results. The cognitive test takes approximately 15-25 minutes to take depending on the individual and how long is spent reading the separate set of instructions before each area of the testing is started. Once the blood work is completed, a report will be generated demonstrating the results of all metrics that were completed. If the cognitive function test is completed after the blood work has already generated a report, the system will regenerate a new test with the cognitive function data within 2-3 minutes.
Practitioners should review the video below then the article summary below it; understanding that there are two ways to register kits provides great power and flexibility to grow their practice and their nutritional compliance.
Summary:
A kit can be registered in one of the following ways; each with its own advantages:
1) through the BrainSpan Portal (requires the provider to be logged in to their account at https://provider.brainspan.com) as shown in the image below:
2) By either the patient or provider/staff going to the public facing BrainSpan website (www.brainspan.com/register) and registering the kit
as shown below:
Important Considerations to Help Expand Your Practice
Because each kit is assigned to the provider when the kit is ordered, this allows the provider to have the kits self-registered and still automatically go directly into their account. This provides tremendous reach and flexibility to meet the demands of various situations where logging into the account and registering the test for the patient would be both impractical and cumbersome.
Examples of situations where this functionality should be leveraged is in drop shipping kits to patients (especially helpful for retesting and saves an extra trip to the office) and when speaking at a class or outside events and distributing the tests to the clients.
Examples of situations where having your patient register the kits on the website is particular beneficial:
REPORTS AND PROCESSING
By default, you will always be notified by email when a patient’s report is ready and viewable (which requires a minimum of the fatty acid panel to be processed by our lab). If you do not want to receive notifications on reports (perhaps because your staff is inside the portal routinely), you can turn off that notification in settings. At this point nothing has been sent to the patient.
You have 30 days from that point to either:
1) Email the patient access to the report as shown below by clicking the “Email Report” link in the “Lab Status” Column when the patient has completed all testing (minimum of the fatty acid panel).
2) Download, share, and mark as reviewed (“Mark as Reviewed” is the column to the right of the lab status column.
To meet all regulatory requirements, you must always use the patient’s email when registering each kit. As the provider, you are in charge of the report delivery process and have 30 days to mark it as sent or reviewed before the system automatically sends the report by email using the email used when registering the kit. Failure to register a kit to the patient directly will cause a hold on the report and account and requires documentation and notification to BrainSpan of exceptional circumstances.
The fatty acid panel must be completed to generate a report. Generally speaking, the cognitive function test is completed first, at the time the kit is registered. This will be evident as the provider's portal will show the word "Completed" under the cognitive test column, within the assessments tab. There is no report made available, however until the lab has finished processing the sample and we have uploaded the data and generated the report (this all occurs within 24 hours of the sample finishing the technical aspect of testing.
When this last process occurs, the provider account is sent an email notification that the results are available (provided that notification is not turned off within the Settings tab of the provider account).
Some practitioners prefer to have a workflow in which the test kit is registered, sample collected, and when the patient returns to review results in approximately 10 business days, they will complete the cognitive test. In this workflow, the patient arrives approximately 20 minutes before the appointment to review the results. The patient is provided access to take the cognitive test either through an email link or through the provider portal directly. As soon as they are completed, the report will re-generated within 60 seconds with all of the cognitive function and fatty acid panel data that was done approximately 10 days ago. Either workflow is fine, provided there is no more than 14-21 days separating the cognitive function test date and the date the finger stick was completed.
You can view the BRAINSPAN® partner report options by going to the main partners page and selecting the nutritional company from the available options. This will also take you to their mini-page on the BRAINSPAN® website where you can download a sample report or learn more about specific algorithms and how they function. For the main, non-branded BRAINSPAN® default report, click on sample report.
The provider has complete control of the report delivery for up to 30 days from the date the lab is processed. Control can be relinquished so as to ensure that the system automatically provides the patient access to the report if desired by changing the default report delivery in the Settings Tab. If desired, simply turn on the "Automatically send report to patient as soon as it is available" as shown in the image below (Note that the default setting for this is off, thereby requiring the provider to give access to the patient manually).
Automatic Report Sending at 30 Days
At 30 days of the report being generated, the system will only automatically send the email with access instructions to the patient regardless of the delivery settings shown above if there is no indication that at least one of the following has occurred:
If the option of downloading and printing or providing access directly by the provider is desired, the following steps must be taken to ensure the non-elective email is not sent designed to meet all regulatory requirements.
Click the "Mark as Reviewed" hyperlink text in the column labelled "Reviewed with Patient" as shown:
This will then bring up the Reviewed with Patient confirmation dialogue box. Click the "Submit and Mark as Reviewed", after reviewing the report and providing them a copy (both are required).
After doing so, when returning to the "Reviewed with Patient column" the hyperlinked text will be replaced with a box and a checkmark on the inside of it, indicating and confirming that you provided access directly outside of the portal through a physical or digital manner.
As long as the above process is done, or if not, that the provider has clicked the "Email report" hyperlinked text in the column just to the left of the reviewed with patient box circled above, they system will not send the non-elective access email at 30 days to the patient.
NOTE: Always register each kit using the patient's email address and not a provider or clinic email which will cause your account to be locked and flagged for regulatory reasons.
There are two ways that you can deliver the report at your desired timeframe as described below. These are critical to understand to optimize your clinical utility of the assessment. The only other way to receive the report is if you turn your report delivery setting to "Auto send when report ready" within your setting tab. This is not covered here but it is important to know it is there depending on how integrated you want the assessment to be in your program and face to face consultations.
First Way to Deliver the Report
The first and most common way a client can receive the report is when the provider manually clicks on "Email Report" within their provider portal as shown below.
When this button is pushed, the patient receives an email with instructions on how to securely access their results.
Second Way to Deliver the Report-Access, Print, and Mark as Reviewed
The second way that the patient receives the report is if during the return visit to go over the results the provider simply downloads the report by clicking "View HTML report" and then clicks the "Print PDF" button on the report. Immediately after reviewing the report, they must click "mark as reviewed" in the column immediately to the right of the Lab Status column. This must be done prior to 30 days as noted in a previous question.
To first access the report, and if desired, produce a PDF that can be emailed directly from the provider or printed out and given to the patient at the time of their appointment to review, complete the following steps:
STEP 1: Go to tab “C” or “Assessments, as shown below within the Provider Portal:
STEP 2: Click "View HTML Report" which pulls up the report within your browser on the computer and allows the best initial experience with the graphics, calculators and soon, interactive videos (Google Chrome or Firefox is recommended, Internet Explorer is not supported and will render the report as if specific sets of data are missing).
STEP 3: Click the blue button that reads "Print PDF" as shown in the image below. [Alternatively, please note that if you experience any difficulty with this button, it could be browser related and you can simply go to the top of the screen with the browser open and click the "File" menu option for the browser, then "Print".]
When downloading as a PDF, whether for electronic storage, emailing, or printing, be sure to set the print format size to A4, the universal equivalent of 8.5" x 11" to ensure improper breaks do not occur in the report as shown in the image below.
As mentioned above, do not forget when printing and downloading to mark it as reviewed or also send the patient the report access by email. To mark it as reviewed, and prevent the auto-send of the report to the patient at 30 days, do the following steps as a continuation of the steps above:
STEP 1: Find the patient listed in your assessments tab. Go to the “Mark as Reviewed” column display next to the lab status as shown below for the assessment reviewed:
STEP 2: This will pull up the confirmation box as shown below and you will need to click the blue box that submits the report as reviewed:
GETTING STARTED
If you are a practitioner, and would like to experience BrainSpan for yourself, we have a trial kit option you can take advantage of. First, validate reseller eligibility, then you will see the trial kit option and how the program is designed.
The general public can also purchase our consumer version of the device and report; and if desired, be referred to a BRAINSPAN® practitioner in your area.
The best way to view pricing along with any current specials is simply to validate your practitioner status here and you will go right to the pricing and order page. You can also view the kit wholesale pricing by going here: https://www.brainspan.com/pricing
Practitioners will receive an email with instructions on accessing their account within 24 hours after their first wholesale purchase on the website unless alternative arrangements have been made by discussing with the support team. The email will be from BrainSpan (info@brainspan.com) and will look similar to below. When you see this email, you should take a few minutes to click the link and set up your password:
(Note: Most accounts also go through a brief manual review before activation. If you do not see the confirmation and password creation email within 24 hours, please search your email inbox for "info@brainspan.com" and if you do not find it, then call BrainSpan Support at 800-535-1518 and select option 3 from the menu for the new provider hotline.)
Be sure your password has at least 8 characters, 1 capital letter, and 1 symbol.
BILLING
If you purchased the product directly use this page, locate your Order ID on your receipt and then go here: https://www.brainspan.com/support-billing
If you cannot find your order ID, please email support@brainspan.com.
Refund policy: Kits-You have 30 days from the date of purchase to request a refund. The product must be mailed to BrainSpan with a copy of the receipt indicating the date of purchase. BrainSpan will inspect the kits for any damage and usability. All product deemed to be "as new" will be refunded less a 25% re-stocking fee. Marketing materials: Marketing materials are non-refundable unless damage occurred in transit or the printing material is discovered to be defective in presentation or function.
If you are a practitioner, and would like to experience BrainSpan for yourself, we have a trial kit option and other reseller options. First, validate reseller eligibility, then you will see the features, pricing and product options.
The general public can also purchase our consumer version of the device and report here; and if desired, be referred to a BRAINSPAN® practitioner in your area.
The best way to view pricing along with any current specials is simply to validate your practitioner status and you will go right to the pricing and order page. You can also view the kit wholesale pricing by going here: https://www.brainspan.com/pricing (however, you cannot make purchases from that page)
Yes, the BrainSpan Core Assessment is a covered health expense; even if we just examine the independent utility and clinical value of the BrainSpan Omega-3 Index measurement which we will discuss in greater detail below. Special thanks to Dr. Bill Harris, PhD who contributed to this article.
For millions of Americans every year, it will be time to find a new health insurance plan or renew an existing one. But thankfully this blog is not about health insurance. This blog is about the BrainSpan Core Assessment and how it is covered by your Health Savings Account (HSA) or Flexible Spending Account (FSA).
The BrainSpan Core Assessment is either a self-ordered or practitioner recommended test...and is a self-administered test the patient can do at-home – it does not require an office visit or a doctor’s order. In the situation where it is self-ordered online off of a website and where the patient self-administers the test, the cost of the test cannot be reimbursed by third party payers (insurance or Medicare). So we want to be sure to stick with the option (as it pertains to using HSA/FSA funds for the test) where it is recommended and administered by a practitioner.
When the test is ordered by a doctor, then it can be reimbursed, with either the physician’s office or the patient him/herself submitting for reimbursement. Therefore, the good news is that the BrainSpan Assessment, even if we just consider the Omega-3 Index and not the cognitive function, in most settings, can be covered by HSA/FSA plans. The fact that we pair it with a well validated and clinically accepted cognitive function test only secures the testing package as eligible not to mention the other fatty acids and clinical summary interpretations that we provide.
First, what are HSA/FSA accounts and how can they help your patients?
If your patient has a high deductible health insurance plan, an HSA would work in conjunction with a tax-free savings account from which you can pull money to pay for expenses not covered by a regular health plan. Healthcare.gov describes a high deductible health plan as one that carries a higher deductible than a traditional insurance plan, and that has a lower monthly premium.
The IRS defines a high deductible health plan as any plan with a deductible of at least $1,350 for an individual or $2700 for a family. In terms of how much you can contribute to an HSA, the IRS has set a limit for individual contributions at $3450; the limit for a family is $6900 as of the publication of this article.
So where can you go to set up an HSA?
Apparently, it’s as easy as visiting a local bank or talking to your stock broker, insurance company or credit union. TheBalance.com points out that banks, credit unions and insurance companies will only have their own specified plans to offer you. Brokers on the other hand will have several options.
The CollegeInvestor.com, which caters specifically to young adults, lists Fidelity, Lively, HSA Bank and Optum Bank as some of the leading choices for opening an HSA account. Optum bank is part of Optum, the technology services division for UnitedHealth Group. So if you work for a major employer, chances are this will be your HSA provider. There is also a robust search tool that will compare and contrast HSA providers for your patients, so they can make a truly informed decision.
According to HealthInsurance.org, an HSA account also functions as an interest-bearing nest egg that grows until you retire, similar to an IRA. In fact, a recent article comparing IRAs and HSAs said people might opt for the latter, especially if funds are limited. “Most people don’t think about an HSA … like a savings account. Instead, they think of it as an account where you set aside money to spend on healthcare items during the current year."
“That view needs to change,” the article said. “An HSA can be a great addition to an IRA or 401(k) plan, and if funds are limited it might be better to contribute to an HSA instead of the IRA.” Why? Because, as the article points out, “an HSA is like an IRA account on steroids.”
The author went on to explain that with a traditional IRA or 401(k), if you are eligible, you get a tax deduction for the amount you contribute to the plan. The money grows tax deferred, and then you pay taxes when you withdraw it in retirement.
But with an HSA, you get the same tax deduction when you contribute money, but when you use the money in your HSA for medical expenses and qualified health insurance premiums, it comes back out tax-free. “Where else do you get to contribute tax-deductible dollars and withdraw them tax-free? Nowhere else that I know of,” the author said.
The point of an HSA is to give you better control over how your patients spend that money on medical expenses. Some of the “expenses” covered by an HSA include deductibles, copays, coinsurance, vision and dental care, and yes, nutritional status tests like the BrainSpan which fits under the categories of “laboratory” or “diagnostic” tests.
So what about an FSA?
An FSA is also a tax-advantaged account that allows people to pay for qualified medical expenses and works in combination with any health plan. In fact, you don’t even need a health plan to get an FSA. Your FSA is set up by your patient's employer. An HSA by contrast can be set up by the patient or their employer, but only if they have a high deductible health plan.
Typically the money a patient puts into this account is funded through a payroll deduction. However, employers can also put money toward this account as well. Employees can use the full amount designated for their FSA even if the full amount has not been deposited by the employee/employer.
Like an HSA, the typical covered expenses by an FSA include deductibles, copays and coinsurance, as well as qualified medical expenses not covered by a patient's health plan. And yes, again, the BrainSpan Core Assessment would qualify because it is considered a laboratory or diagnostic test from the perspective of the Omega-3 Index (not to mention the cognitive function part of the assessment).
One of the biggest differences between an HSA and FSA is that the money in an FSA must be used within the year, or by March 15 of the following year. In other words, “use it or lose it”. And you can’t use the money in an FSA for anything but medical expenses.
As always, though, it is best to check with your own health savings plan if you’d like to verify this as a covered expense before purchase.
These statements have not been evaluated by the Food and Drug Administration. This test is not intended to diagnose, treat, cure, prevent or mitigate any disease. This site does not offer medical advice, and nothing contained herein is intended to establish a doctor/patient relationship. Our lab is regulated under the Clinical Laboratory improvement Amendments of 1988 (CLIA) and is qualified to perform high complexity clinical testing.
BrainSpan's Practitioner Core report is an integrated testing process involving a whole blood collection on a sample card using the fingerstick method and a 4 part cognitive function test performed on a personal computing device such as a tablet or iPad (most ideal). The data from both parts of the test is used to generate a 10-12 page PDF report.
While billing codes and reimbursement are the sole responsibility of the practitioner, BrainSpan has performed extensive research into this topic to best advice practitioners who would like to bill insurance or a federal program such as Medicare to ensure we are providing the best, most up to date information possible. You should always check with your state medical licensing authority as well as HHS for the latest updates and if necessary, consult a professional advisor.
Neurocognitive Testing and Fatty Acid Testing
A set of procedures are required to collect the sample and perform the cognitive function test which can be aligned with specific CPT codes since the lab is CLIAA certified. However, there may be additional supplementary questionnaires that can easily be added to the BrainSpan assessment matrix that are made available to you in your portal (see "Help" tab resources) that can be used to augment the clinical evaluation and enhance the clinical utility of BrainSpan. These assessments are well accepted in many cases by both federal, state, and private insurance corporations and when combined with BrainSpan, and specific physical history and exam required data, may objectively meet a host of specific required information for the evaluation and management (E&M) of different ICD-10 diagnostic codes. This is because when combining objective blood and functional data with standardized questionnaires that have also been well validated, a more robust but also more specific tools is effectively created from the entire testing matrix.
CMS has sent out several memos mandating coverage for these codes. Generally, there is widespread reimbursement and coverage by payers for the procedure codes used for these. Most often, additional survey assessments are necessary (but also many are free and included in the resources for new practitioners) and the combination of these plus the other parts of BrainSpan offers a powerful clinical tool in addition to a reimbursable viable tool in many cases.
Generally, a minimum of 31 minutes must be provided to report any per hour code. Clinical measures generated from patient and informant testing procedure codes then, in our estimation, would become reimbursable by many public and private payers and when combined with the neurocognitive testing. This can help augment and document the complexity and higher reimbursement rate for the appropriate E&M (new 99201‐99205 and established 99211‐99215 patients) codes. If nothing else, you will be providing a very strong and reasonable case that should be professionally reviewed with great attention given that in many cases you may not know for certain until submitting and discussing with one of the reimbursement representatives.
Coding
Our recommendation would be to consult our billing guide (link below) but in general the following codes are in our estimation most relevant.
-Recent regulatory guidance provides a great deal of information on how to properly leverage this code for medicare patients and it clearly lays out the breadth and scope which is intended by regulators to allow a broader population of caregivers and patients to be engaged with brain health promotion and prevention.
Also indirectly, recent guidance and professional discourse on the topic of Code 99482 and which providers can use this should indicate to us all the tremendous level of concern at the highest levels of our society and government regarding both the burden of chronic neurodegenerative disorders like age related cognitive impairment and dementia but also the importance of taking proactive measures to engage patients to prevent it.
If you are a current BrainSpan provider, please go here to download the reimbursement guide or access the each guide directly if you have an expanded portal within your Expanded Practitioner Resources.
New Cognitive Impairment Assessment and Care Planning Billing Code 99483:
Recent regulatory guidance provides a great deal of information on how to properly leverage this code for medicare patients and it clearly lays out the breadth and scope which is intended by regulators to allow a broader population of caregivers and patients to be engaged with brain health promotion and prevention.
Also indirectly, recent guidance and professional discourse on the topic of Code 99482 and which providers can use this should indicate to us all the tremendous level of concern at the highest levels of our society and government regarding both the burden of chronic neurodegenerative disorders like age related cognitive impairment and dementia but also the importance of taking proactive measures to engage patients to prevent it.
If you are a current BrainSpan provider, please go here to download the reimbursement guide or access the each guide directly if you have an expanded portal within your Expanded Practitioner Resources.
COGNITIVE TEST TROUBLESHOOTING
Step 1: Determine if your internet browser is current and meets the requirements as one of the approved browsers (see requirements to run the cognitive test article). Try using a different browser (in its latest version) as a temporary workaround. We recommend the Chrome Browser. Install any updates. Ensure you have adequate internet connectivity. See the article above and ensure your device meets the requirements.
Step 2: Next, delete all the cookies and browser history from all active browsers.
Step 3: Reboot Device
Fixing other common errors
-Locked screens or non-responsive screens
Step 1: Determine if your internet browser is current and meets the requirements as one of the approved browsers (see requirements to run the cognitive test article). Try using a different browser (in its latest version) as a temporary workaround. We recommend the Chrome Browser. Install any updates. Ensure you have adequate internet connectivity. See the article above and ensure your device meets the requirements.
Step 2: Next, delete all the cookies and browser history from all active browsers.
Step 3: Reboot Device. It is a good idea if you have any trouble at all to always reboot the device which can clear out memory hogs and free up the RAM to run the test. Here is how to reboot/soft reset Apple Device: press and hold both the sleep and home buttons for about 10 to 15 seconds (ignore the red slider), after which the Apple logo should appear - you won't lose any content, it's the iPad equivalent of a reboot.
Locked screens or non-responsive screens
REPORT/ASSESSMENT TROUBLESHOOTING
To change your report type, simply click here.
The graphic below also shows the timelines of mailing, processing, and receiving results and when you should consider submitting a ticket or replacing if we have not received the sample but it was mailed in.
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