What Are Unproven, Investigational or Experimental Procedures?

by  Brandy Brimhall CPC CMCO CPCO CCCPC CPMA
June 23rd, 2016

Many specialties, including chiropractors, perform services that may be deemed "experimental,
investigational and unproven."  Individual payer coverage determinations, as well as state boards,
generally offer specific information defining this type of procedure and any other notice or guideline
that providers must be aware of and adhere to.

The terms "unproven, experimental or investigational" are 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, by being defined as "unproven, experimental or investigational", it does not imply that
these procedures do not work.  It means that the required protocol and the scientific research and
evidence have not been fulfilled and/or approved in order to qualify these procedures as "proven" and
medically effective.  To accomplish this, there are expansive government guidelines and procedures
that must be met and maintained.  

Many state organizations expand upon this definition and/or identify those specific supplies and
procedures that may be deemed "experimental, investigational and unproven" in that state.   Many
states also require that providers collect a signed Informed Consent form that clearly identifies those
supplies and procedures that are designated as "unproven, experimental or investigational."  In states that do have this requirement, the patient signature on the Informed Consent should be collected prior to providing the service or supply to the patient.  Local 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.  For those states that do require the Informed
Consent form, the penalties for non-compliance of this rule may vary by state and by circumstance 
Additionally, there are states that "recommend or suggest" that an Informed Consent form be
provided to patients for these types of services and supplies, but they do not definitively say that the
Informed Consent is "required."  If you find that this is the case in your state, it would be wise to avoid taking the gamble and simply just provide the Informed Consent form for the benefit of the patient and for the protection of your practice.

Why does it matter?  It matters largely for the purpose of proper disclosure to your patients and 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
the patient has not been properly educated as to what this "label" means.  Meanwhile, your patient decides that he/she would like to learn more about this procedure and does some research on the
internet.  From their own research, your patient learns that the service he/she is receiving is deemed
"unproven".   

What is likely to be his/her feeling and reaction?  One could assume that a feeling of being misled and taken advantage of could be likely.  After all, this patient has been paying for a service that doesn't have "qualified" evidence of generating medical or functional improvement. It is easy to see how this  finding could be upsetting to a patient.  A possible reaction he/she might have is to discontinue care, and possibly discuss the situation with friends or family he/she has referred.  This could create a domino effect of patients who now feel as though they have been misled, and then of course, he/she/they may even make the decision to contact your state board to complain.  

All of this could poorly reflect upon a practice and not only be damaging to a practice's reputation, but also take valuable time to rectify, cause stress, and even result in some form of penalty from your
state.  The good news is that this unfortunate occurrence can be easily avoided by practices simply
being aware of and adhering to guidelines set forth for their benefit and their patients'.  With this
example, you can see one reason why it is necessary and beneficial to collect Informed Consent Forms to record patient understanding and acknowledgement regarding the "labeling" of certain procedures.


This Consent Form, with applicable service(s)/supplies listed, serves as your "permission slip" to
provide these services/supplies to the patient.   The example described also demonstrates how it is
critically necessary for practices to properly educate patients on the services being recommended and
provided to them, as well as to discuss goals and expected outcomes.  

In regard to payers, they too have defined those services and supplies that are deemed "unproven,
experimental or investigational."  These services or supplies are not generally allowed or payable by
third party payers.  Here again, providers have the responsibility to verify this information with those
payers that claims are submitted to.  The chiropractic services coverage guidelines can usually be
obtained easily either online or by contacting the payer directly.  This too, should be verified annually
for updates and changes.  

Payer guidelines are of importance due to the possibility of a practice intentionally or unintentionally
misleading a patient by assuming and/or leading the patient to expect that their coverage and benefits will pay for this type of procedure or supply.  This may not only cause cash flow problems for a practice due to claims delays and denials, but it may also be upsetting to patients if the payment for these services unexpectedly must come out of their own pocket.  

Another factor here comes with coding, and the instances that inaccurate and incorrect codes are used 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 havethe responsibility to learn and adhere to proper guidelines for coding as well as for billing to individualpayers.  

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


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 brief, random sampling provided as an example.

To protect practices and patients, local rules and regulations for these "unproven, investigational or
experimental" procedures and supplies should be learned and followed.  Understanding payer guidelines is also important for the reasons mentioned above.  Practices are urged to not only be
proactive in learning those rules in place for them when providing "unproven, investigational or
experimental" procedures, but they should also regularly review all applicable rules and regulations in
order to avoid unnecessary and potentially costly situations.   

Brandy Brimhall  CPC, CMCO, CCCPC, CPCO, CPMA
ChiroCode Institute
Director of Education

References:

http://www.rules.utah.gov/publicat/code/r414/r414-01a.htm

http://www.online-health-insurance.com/health-insurance-resources/dictionary/experimental-or-unproven-procedures.htm

Colorado Board of Chiropractic Examiners Rule 15

https://www.myoptumhealthphysicalhealth.com/ClinicalPolicies/473.pdf

What Are Unproven, Investigational or Experimental Procedures?. (2016, June 23). Find-A-Code Articles. Retrieved from https://www.findacode.com/articles/what-are-unproven-investigational-or-experimental-procedures-28072.html

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