Are You Providing “Unproven, Investigational, or Experimental” Procedures?
PERSPECTIVE
Kathy Mills Chang
MCS-P, CCPC, CCCA and Brandy Brimhall, CPC, CPCO, CMCO, CCCPC, CPMA
"From that research, your patient learns that the service he/she is receiving is deemed "unproven." In this event, it is easy to see how your patient may assume that he/she has been misled and taken advantage of."
There is no better time than now to review your state’s guidelines and third-party payers’ policies on unproven, investigational, and experimental procedures. Although you may find yourself a bit wide-eyed in disbelief while reviewing the types of procedures affected, you will be taking a big step forward in minimizing risk of billing errors for your practice.
How is Unproven, Investigational or Experimental defined?
First, the terms “unproven, investigational, or experimental” 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 to be acknowledged as medically effective for the improvement of function for specific conditions or treatment.”
To be clear, when a carrier or state board defines a procedure as “unproven, investigational, or experimental,” it does not mean that these procedures do not work. It simply means the required protocols, scientific research, and evidence have not been fulfilled or approved to qualify these procedures as “proven“ and “medically effective.” To accomplish this, extensive government guidelines and procedures must be met and maintained.
As you might imagine, many state board guidelines go one step further and expand upon this definition or identify specific supplies and procedures that may be deemed “unproven, investigational, or experimental” in their 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, investigational, or experimental.” For states with this requirement, the signed informed consent form should be collected from the patient prior to rendering the said service or supply. To help incorporate a proper informed consent form, if applicable, local state guidelines may also offer specific verbiage that practices should use when preparing their informed consent form.
Practices have the responsibility to verify this guideline in their region and should annually check for updates or changes to maintain compliance. Additionally, states “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 form is a required document. If this is the case in your state, it would be wise to take the more proactive approach and simply provide the informed consent form for these types of procedures for the benefit of the patient and for the protection of your practice.
It Really Does Matter
The primary reason it matters is because proper disclosure to your patients keeps you from 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 about what this label means. As such, without properly defining it for your patients, the sound of the terms could be quite alarming to them. Just imagine that your patient decides that he or she would like to learn more about this procedure and does some research on the internet, as patients often do. From that research, your patient learns that the service he or she is receiving is deemed “unproven.” In this event, it is easy to see how your patient may assume that he or she has been misled and taken advantage of. After all, this patient has been paying for a service that doesn’t have adequately qualified evidence of achieving medical or functional improvement. Understandably, this finding could be upsetting to a patient. This lack of communication might result in the patient discontinuing care and possibly discussing the situation with friends or family he or she has referred. This could create a domino effect of patients who now feel as though they have been misled, and who might make the decision to contact your state board to file a complaint.
All of this could reflect poorly 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 board. The good news is that this unfortunate occurrence can easily be avoided by practices simply being aware of and adhering to guidelines set forth for their benefit and their patients’ benefit. With this example, you can see one reason why it is necessary and beneficial to collect informed consent forms to record patient understanding and acknowledgment regarding the official labeling of certain procedures. This consent form, with applicable service(s)/supplies listed, validates that you have properly communicated and received authorization by the patient to provide these services/supplies. It is critically necessary for practices to properly educate patients on the services being recommended and provided to them, as well as to discuss and document goals and expected outcomes for these types of procedures.
Third-Party Payer Guidelines
Third-party payers also have defined services, techniques, and supplies that are deemed “unproven, investigational, or experimental,” which means they are not covered by the payer. Providers have the responsibility to verily this information with those payers. The chiropractic services coverage guidelines or medical review policy can usually be obtained easily online or by contacting the payer directly. This also should be verified annually for updates and changes.
Payer guidelines are important because of the possibility of a practice intentionally or unintentionally misleading a patient by assuming or leading patients 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.
Avoid Miscoding
A common error we see is a practice’s use of an incorrect code that inadequately describes the service to simply be paid. Not only is miscoding out of alignment with required coding guidelines, but the issue of fraud and abuse also becomes a concern. Government and payer investigations along with discoveries of errors in billing can be crippling to a practice. Providers have the responsibility to learn 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 by state. For your reference, a short list of some procedures commonly performed in chiropractic that may be considered investigational include the following:
• 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)
Wobble chair
Thermography
Biofeedback
Spinal decompression
Detoxification foot bath
Color therapy
Aqu amas sag e/hydrotherapy
Note that the list 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 understood and followed. Understanding payer guidelines is also important for the reasons mentioned earlier. Practices are urged not only to be proactive in learning those rules in place for them when providing “unproven, investigational, or experimental” procedures, but also to regularly review all applicable rules and regulations to avoid unnecessary and potentially costly situations.
References:
1. http://www.rules.utah.gov/publicat/code/r414/r414-01a.htm
2. http://www.online-health-insurance.com/health-insurance-resources/dictionary7experimental-or-unproven-procedures.htm
Colorado Board of Chiropractic Examiners Rule 15
1. https://www.myoptumhealthphysicalhealth.com/ClinicalPolicies/473.pdf
2. http://www. aetna. com/ cpb/medical/data/100_199/0107.html
Kathy Mills Chang is a certified medical compliance specialist (MCS-P), certified chiropractic professional coder (CCPC), and certified clinical chiropractic assistant fCCCAJ. Since 1983, she has been providing chiropractors with reimbursement and compliance training, advice, and tools to improve the financial performance of their practices. Kathy leads a team of 30 at KMC University and is known as one of our profession’s foremost experts on Medicare, documentation, and CA development.
Brandy Brimhall, CPC, CPCO, CMCO, CCCPC, CPMA, has been an advocate to chiropractic practices since 1999. She has excelled in the areas of billing, coding, collections, compliance, and practice administration. She has obtained multiple certifications to further enhance her skill set to assist practices. Brandy joined KMC University in 2017 as the Director of Membership where she uses her advanced skills to guide our dedicated account managers in creating the most optimal membership experience. She also provides one-on-one support to clients in the areas of compliance, coding, accounts receivable, and more, while also continuing to educate the chiropractic profession through online webinars and in-person seminars.
Kathy or any of her team members can be reached at 855832-6562 or info aKMClIniversity. com.
