Rules for Rendering Unproven, Investigational or Experimental Procedures

July 1st, 2019 - Brandy Brimhall, CPC, CMCO, CCCPC, CPCO, CPMA
Categories:   Chiropractic   Compliance  

Improve documentation, select proper codes and minimize your practice risk when performing procedures in this category.

If you haven’t reviewed your state guidelines or taken a recent look at third-party payer policies on unproven, investigational or experimental procedures, now is the perfect time to make sure you’re up to speed with this important information.  Most providers are surprised to see commonly used devices or techniques listed in this category.

Importantly, one would never want to turn a blind eye to this information, as the risk of erroneous coding and billing, inaccurate documentation and non-compliance with payer and/or state guidelines all contribute to the heightened and potentially costly risk for providers and practices who aren’t “in the know” and following required measures.

Defining Unproven, Investigational or Experimental

The terms “unproven, investigational or experimental” appear quite daunting; so, let’s first understand what they really mean.  In relation to treatment, “unproven, investigational or experimental” is a category that is generically defined as: A supply, procedure, therapy or device whose effectiveness has not been demonstrated by required scientific evidence and properly authorized by governing entities in order to be acknowledged as medically effective for the improvement of function for specific conditions or treatment.  

To be clear, a procedure being categorized as "unproven, investigational or experimental" does not mean that it these procedures are not achieving intended results.  What it does mean is that the required processes to present scientific research, supporting evidence and clinical findings have not been fulfilled and/or approved by governing entities in order to qualify these procedures as "proven" and, therefore, medically effective.  To be considered “proven,” there are very extensive, expensive and rigorous government guidelines and procedures that must be met and maintained. In some cases, procedures in this category do have multiple clinical studies and research documents available, which may demonstrate that such procedure(s) have been found to produce inconsistent results, warranting the need for being labeled in this particular category.

Further, many state board guidelines go one step further and expand on this definition and/or identify those specific devices and procedures that may be deemed "unproven, investigational or experimental" in that state.   As such, for protection of the providers and the patients, many states also require that providers collect an Informed Consent form that clearly identifies those devices and procedures that are designated as "unproven, investigational or experimental."  For states that do have this requirement, the appropriately signed Informed Consent form should be collected from the patient prior to rendering the said service(s). To help implement a proper Informed Consent, if applicable, state guidelines may also offer specific verbiage that practices should use when preparing their Informed Consent form.  

Providers have the responsibility to verify this guideline in their region and should annually check for updates or changes in order to maintain compliance.  In those states that do require or recommend an Informed Consent form for these unproven, investigational or experimental services, the penalties for non-compliance of this rule may be identified specifically in the state guidelines or may even be determined on a case-by-case basis based on what circumstances occurred that resulted in your state board calling you and your practice to the carpet for some level of audit or review.  

Additionally, for states that do not have the requirement or recommendation that an Informed Consent form be provided to patients for these types of services, it may serve as an excellent “best practice” measure to take the more proactive approach and simply just provide the Informed Consent form for these types of procedures for the benefit of the patient and for the protection of your practice.

Why does it matter?  

In the age in which information is at the fingertips of just about everyone, transparency and proper disclosure to your patients is an important and a protective step to take in order to avoid unintentionally misleading them.  For example, let's suppose you are providing a procedure to your patient that has been deemed by your state as unproven, investigational or experimental, and you have not properly educated the patient as to what this label really means.  Now, just imagine that your patient decides that he or she would like to learn more about this procedure and decides to research on the internet, as patients often do. From this research, your patient learns that the service is deemed unproven, investigational, or experimental. As you might imagine, the sound of this is likely to be quite alarming and upsetting.

In this situation, it is easy to see how patients may assume that they’ve been misled and taken advantage of by you and your practice.  After all, this patient has been paying for a service that doesn't have sufficiently qualified evidence of achieving the expected medical or functional improvement.  This lack of communication may result in the patient discontinuing care or possibly discussing the finding with friends or family they may have potentially referred. This could create a domino effect of patients who now feel as though they have been misled and are opting to take action steps of their own.  Of course, such a situation could poorly reflect on a practice and not only be damaging to a sound reputation, but also require valuable time and money to rectify, cause stress, and even result in various forms of penalty from your state board.

In more than one instance, this very scenario has resulted in a complaint being filed with a state board.  However, with proper communication between practices and patients, this stressful and costly situation is completely and easily avoidable.  Implementing the appropriate Informed Consent, with applicable service(s) listed, validates that you have properly communicated with and received authorization by the patient to provide these particular services.  

Third-Party Payer Rules

Importantly, third-party payers also have defined particular procedures and techniques that are deemed "unproven, investigational or experimental." These procedures are not generally covered or payable by third- party payers. Here again, providers have the responsibility to verify these details with those payers that claims are submitted to. This too should be verified annually for updates and changes.

Payer guidelines are of great importance, as a practice may find themselves unintentionally misleading patients by assuming and/or leading patients to expect that their coverage and benefits will pay for this type of procedure.  Additionally, the practice also has heightened risk in this case of selecting an improper code for data entry and/or billing. This risk may be quite significant in the event of a records review, as the documentation would not be in compliance with guidelines, and the services billed for may not be adequately supported within the documentation.  Common complications with these avoidable errors could potentially include billing patients for charges that were thought to be covered, writing off charges that were thought to be covered, the need for an expansive records review and audits due to documentation and coding not telling the same story, refund requests, payer recoupments and more.

Another factor with regard to coding is the use of inaccurate and incorrect codes for these services for the purpose of getting paid.  Not only is miscoding not in alignment with required coding guidelines, but the issue of fraud and abuse also becomes a concern. Government and/or payer investigations, along with discoveries of errors in billing, can be crippling to a practice.  Providers have the responsibility to learn about and adhere to proper guidelines for coding, as well as for billing to individual payers.

The list of procedures identified as unproven, investigational or experimental does vary by payer and state.  For your reference, just a few procedures commonly performed in chiropractic that may be considered unproven, investigational or experimental, include:

  • Active Release Technique
  • Cranial Manipulation
  • SOT (Sacro-Occipital Technique)
  • Low Level Laser/Cold Laser for uses not approved by the FDA
  • NET (Neuro Emotional Technique)
  • Iridology
  • Thermography
  • Biofeedback
  • Spinal Decompression
  • Detoxification Footbath
  • Color Therapy
  • Aquamassage/Hydrotherapy
  • Kinesio Taping
  • Stem Cell Therapy

 Note that the list above is not specific to any state or to any payer, nor is it a complete list.  It is only a very brief, random sampling provided as an example.

To protect practices and patients, local and payer rules and regulations for these unproven, investigational or experimental procedures should be learned and adhered to.  Implementing the proper Informed Consent for patient transparency and education, along with making a good faith effort to code and document properly are significant risk management strategies for practices.  For assistance with learning local and payer guidelines and taking proactive steps to protect your practice, reach out to your certified on-demand Virtual Chiropractic Assistant,


Colorado Board of Chiropractic Examiners Rule 15


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