8 Tips for Regulatory Submissions

It’s MLR day. The review will either go incredibly smoothly, or it will be painful. Based on the 53 comments on the piece that you slotted for a 30-minute review, we’re leaning towards the latter. On top of it all, the piece features an actual patient, and reviews on patient content can be difficult to navigate. At this point, our advice is to get yourself a large coffee and get ready for rebuttal. Promotional pieces featuring real patient stories shouldn’t be scary. The good news is, after reading this, you’ll be better prepared for your next submission and review.

When it comes to getting custom patient content approved, the WEGO Health team has done it all. From unbranded videos to microsites to completely branded social media ads, we consider ourselves experts at receiving that blessed email with the subject reading, “Approved for Distribution.”

With over 13 years of MLR experience and thousands of patient content pieces approved, we’ve learned a few tricks of the trade that help keep programs moving through the regulatory process as smoothly and quickly as possible. Picture a non-scripted patient video going through review and receiving zero comments. Yes, it’s as beautiful as it sounds. And yes, we’ve done it. Quite a few times.

You can do it as well, and below are the top tips for getting patient-centered materials approved by regulatory.

When in doubt, “concept” it out. Before beginning a new program that features patients, it’s always best to kick-off the program with a concept review. This will help you to learn the questions or concerns that your review team will have. You should leave a concept review with a green light from all parties involved to proceed with the program, along with clear guidelines and instructions that will ensure your first formal submission is properly formatted. A concept review ensures that the regulatory team truly understands the program and won’t have any conceptual questions when you submit your formal pieces.

Examples can be your best friend. If you can share examples of a finished product to get MLR to fully grasp your program, do it. Whether it’s internal examples or examples from other companies or brands, regulatory teams like to know they aren’t alone in what they are reviewing and approving, and that similar content has been approved. However, if you’ve sat through any reviews where examples are reviewed, you may hear, “I don’t care about these examples and what other teams are doing.” At that point, abort the example mission and carry on.
Essential asset gathering is key. Incorporate high-resolution logo images, follow company style guides, and leverage social media templates to ensure that submissions are following the latest guidelines.

Don’t recreate the wheel. Regulatory teams are more comfortable reviewing content that is in a format that they are familiar with. If you’re trying to get promotional copy approved, see if there are templates that have been approved in the past that you can use when creating your submission document.

Embrace the annotation station. In all submission documents, if you’re trying to depict actions users can take on a piece, like clicking to play a video or hitting “share” to send to a friend, and those actions for users to take are not annotated, the piece will be kicked back to you. For example, if you’re trying to get promotional copy approved and have an example of an in-feed ad, clicks, likes, shares, and/or comments must be annotated to inform reviewers what actions can be taken. When in doubt, provide extra images and/or video to use as demos to explain available actions as thoroughly as possible.
Have offline discussions with an MLR team lead. Getting ready to submit a new piece from a new program for review? If so, one tactic we’ve worked with clients on is to try and schedule a call with the regulatory lead to walk through the format of the document. A lot of times they can point out potential red flags prior to a submission, which can help save your review timeline. This is also an opportunity to refresh their memories of the program, especially if the concept review was weeks or months ago.

Understand the patient relationship. When working with patients, it’s crucial that you understand every aspect of the relationship with the patient. For example, is the patient being compensated for their time? How much are they being compensated? Have they signed a contract and if so, who owns the contract? These questions typically arise during a review or concept review, so be prepared to answer the questions.

Vetting of patient content, or else! In addition to understanding the patient relationship, complete vetting on the patient’s social media channels. You want to ensure that this patient isn’t online talking about inappropriate topics, or posting, “I hate [INSERT YOUR CLIENT’S BRAND HERE]”. The last thing you want is to submit a patient profile for review and have someone from regulatory click on their Instagram feed to see borderline pornography. Save yourself some embarrassment, and do not skip any vetting.

Partnering with patients is no longer a nice to have, it’s a need to have. Brand teams need not let their fear of a complicated MLR process prevent them from creating user-generated authentic content that best resonates with their community. By following these tips, can you bring compelling content to life and not lose credibility with your MLR team.

Proposed Federal “Distance Learning” Rules Help Big Tech Shut Down Brick-and-Mortar Public Schools, Replace Human Teachers with AI

The DeVos Department of Education’s new “Proposed Rules” for federal regulations of “Distance Education and Innovation” (85 FR 18638) will effectively open the floodgates for online education corporations to put public brick-and-mortar schools out of business by streamlining “adaptive-learning and other artificial intelligence” technologies that replace “human instructors” with “competency-based education (CBE)” software which provide “direct assessment” through “subscription-based” course-ware that data-mine students’ cognitive-behavioral algorithms to “personalize” digital lessons.

What Is Computerized CBE? No More Classrooms, No More “Credit Hours”:

As I have documented in several articles, “CBE” is a euphemism for educational methods that deploy computer modules based on Harvard Psychologist B. F. Skinner’s “teaching machines,” which implement operant-conditioning methods to “shape” student learning into “competent” behaviors geared toward college or career readiness. The terms “competency-based education” and “CBE” are used 147 times in the new Proposed Rules for 85 FR 18638, which is a total of 64 pages long. Compare this to the 392-pages of federal legislation that cover the entire Every Student Succeeds Act (ESSA), which only contains 6 references to “competency-based education.”

According to Skinnerian  CBE advocates, competency-based computer learning at home is better than human instruction in a classroom because the one-to-one student/computer ratio enables each student to learn at his or her own pace. 85 FR 18638 states “CBE programs . . . measure student progress based on their demonstration of specific competencies rather than sitting in a seat or at a computer for a prescribed period of time. Many CBE programs are designed to permit students to learn at their own pace.” Stated differently, when a student enrolled in CBE course-ware is ready to move on to the next lesson, he or she can click on the next learning module without having to wait for the teacher to deliver the next lecture. And if a CBE student is not ready to move on to the next virtual lesson, he or she can re-mediate by repeating the same digital learning module without being “left behind” when the teacher moves on to the next lecture.

“Subscription-Based” Distance Learning, Pay-as-You-Go

To facilitate “self-paced” CBE learning, online education
corporations and other software companies are offering “subscription-based” e-learning services that enroll students on a pay-as-you-go basis. These self-paced CBE courses allow a student to “subscribe” for enrollment into virtual-learning
modules which can be rolled over with monthly subscription fees for as long or as soon as it takes for the student to demonstrate “competency” in the course.

Now that basically every US school has converted to virtual
“distance learning” through computers, 85 FR 18638 is attempting to loosen federal requirements for self-paced CBE course-ware so that online education corporations can rake in  federal funding for delivering more subscription-based
“competency” lessons through digital platforms:

[c]urrent regulations require an institution to evaluate a student’s pace of completion by dividing completed credits over attempted credits. This calculation is difficult to apply in competency-based programs, including subscription-based programs, because there is often no set period of time during which a student “attempts” a competency in such programs; rather, the student works on a competency until he or she can demonstrate mastery of it. Given the limitations in this proposed definition on a student’s eligibility to receive additional disbursements [of federal funds], we believe it is unnecessary and needlessly burdensome for an institution’s SAP policy to include pace requirements for subscription-based programs.

In other words, these new (de)regulations will relax the
legal requirements for online education corporations to receive federal funds, such as financial aid grants, as payments for students’ CBE subscription fees. It should be noted that  “subscription-based” e-learning is referenced 112 times in
these new Proposed Rules.

Adaptive Learning = Post-Human Artificial Intelligence

As I have documented in numerous articles, self-paced CBE subscriptions and “adaptive-learning” software basically go hand in hand. CBE “course-ware” subscriptions “personalize” lessons for students through “adaptive-learning” computers, which are nothing less than modern digitized versions of the “Skinner box,” or “teaching machine.” Adaptive-learning
software revamps B. F. Skinner’s “programmed instruction” with “artificial intelligence” that automates “stimulus-response” methods of educational psychology to train students for academic and career “competences.”

Essentially, adaptive-learning course-ware enables “self-paced” learning because the psychological-conditioning software “adapts” its lessons based on how the student “responds” to the virtual “stimuli,” such as multiple-choice or short-answer modules on digital windows. The faster the student responds with correct answers, the faster the learning stimuli will progress the student towards full “competence” at the end of the subscription-based course’s module sequence.

Incentivizing broader enrollment in subscription-based
adaptive-learning course-ware, 85 FR 18638 expands
the definition of accreditable “academic engagement” as participation by a student in . . . an online course with an opportunity for interaction or an interactive tutorial, webinar, or other interactive computer-assisted instruction.  . . . Such interaction could include the use of artificial intelligence or other adaptive learning tools.” Under this revised definition of
“academic engagement,” schools will be given expanded flexibility to accredit a vast range of self-paced CBE curriculum’s delivered by online education companies through adaptive-learning AI that programs students with ope-rant-conditioning algorithms.

Moreover, “academic engagement” is being further expanded  to give adaptive CBE course-ware the green-light to phase out certain requirements for human instruction: “[a]ctive engagement . . . could include the use of artificial intelligence or other adaptive learning tools so that the student is receiving feedback from technology-mediated instruction. The interaction need not be exclusively with a human instructor.” Indeed, adaptive AI can deliver “feedback” on student learning through “direct assessment,” which is referenced 226 times in the new Proposed Rules.

Of course, in a bankrupt economy where people are locked down under emergency pandemic, pretenses, such adaptive AI course-ware will be more convenient since the software can be available for the student 24-hours a day (unlike a human
teacher). In addition, the non-human AI bots will be much cheaper than human instructors who need to be fed and housed. So it looks like the proposed (de)regulations will set up incentives which will ensure that the virtual-learning industry is able to swallow up federal education funds while public brick-and-mortar schools and human teachers are starved out into

Sweeping Deregulation of Artificial Intelligence: AI Will Make Decisions for You

To be sure, AI adaptive-learning algorithms are evolving faster than legislators can deliberate on new regulations for such new “machine learning” innovations. Thus, to get out of the way of “progress,” 85 FR 18638 is basically writing a blank check for AI corporations to sell schools and students new e-learning products and ed-tech “updates” without preliminary regulatory permission from the federal government:[t]he current regulations [which] do not address subscription-based programs or consider programs made possible through artificial intelligence-driven adaptive learning.  . . . Because of the time it takes to implement new regulations, it is unlikely that the Department will be able to keep pace with developing technologies and other innovations in real time.

These proposed regulations attempt to remove barriers that institutions face when trying to create and implement new and innovative ways of providing education to students, and also provide sufficient flexibility to ensure that future innovations we cannot yet anticipate have an opportunity to move forward without undue risk of a negative program finding or other sanction on an institution.

To put it another way, AI-learning algorithms evolve faster than legislators can regulate, so these new federal rules will “remove barriers” to AI ed-tech progress by allowing educational institutions the “flexibility” to rubber-stamp new AI course-ware programs without prior regulatory approval from the US Department of Ed.

But if the federal government allows AI ed-tech to develop faster than Congress can regulate, then the Department of Ed will render itself into a mere ceremonial bureaucracy that
has abdicated its authority to AI algorithms, which means artificial intelligence will be in the driver’s seat taking control of the future of education policy as virtual distance learning becomes the mainstream mode of schooling in a post-corona economy.

It should be noted that Edgar McCulloch, who is a Government
Relations representative of the IBM Corporation, sat on the “Accreditation and Innovation negotiating committee” involved in the proposal of these new federal rules. This is worth noting because IBM develops AI ed-tech through its Watson artificial-intelligence program which partners with the globalist Pearson Education LLC: the “world’s largest education company,” which also runs online schooling companies including Connections Academy.

How much stimulus money will be vacuumed up by online education corporations and AI course-ware companies under these new federal rules? Will brick-and-mortar schools be able
to survive in a post-corona economy in which people are either heavily travel restricted or too poor to pay for school buildings and human employees? Will human teachers, or even human ethics, survive in a world in which the total deregulation of technocratic advancement exalts AI as the judge, jury, and executioner of human learning?

John Klyczek on EmailJohn Klyczek on Twitter

John Klyczek has an MA in English and has taught college rhetoric and research argumentation for over eight years. His literary scholarship concentrates on the history of global eugenics and Aldous Huxley’s dystopic novel, Brave New World. He is the author of School World Order: The Technocratic Globalization of Corporatized Education (TrineDay Books); and he is a contributor to the Centre for Research on Globalization, OpEdNews, the Intrepid Report, the Dissident Voice, Education Views, Blacklisted News, the Activist Post, Counter Markets, News With Views, The Saker, Rense News, David Icke News, Natural News, What Really Happened, and the SGT Report. He is also the Director of Writing and Editing at Black Freighter Productions (BFP) Books. In addition, Klyczek holds a black belt in classical tae kwon do, and he is a certified kickboxing instructor under the international Muay Thai Boxing Association.