Orthobiologic Consent Guidelines (Part 2)

Are you considering orthobiologic treatment for pain management and tissue repair? We share a comprehensive consent script to ensure you're fully informed. Understand the risks, benefits, and off-label nuances. Learn about alternatives and post-treatment care.

Stay informed and make informed decisions! Watch the podcast episode now for an in-depth understanding of orthobiologic treatments and consent protocols.

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Transcript

Intro

Hey, I'm Dr. Ariana DeMers. I'm an orthopedic sports medicine surgeon, and I have successfully integrated Orthobiologics into my busy practice so that I can provide a continuum of care and treat patients who are in the gap. The Gap is this gray area in Orthopedics where standard conservative treatments have not been effective but surgery may not be warranted, and we usually tell our patients come back when it's worse. What? These are your patients coming to you for help. Orthobiologics is that solution that can fill the gap and help you treat your patients who are in your office looking to you for help. Orthobiologics can also be an excellent treatment for frustrating problems without good surgical outcomes. This podcast will help you create the Orthobiologics business that will make you love your job again. We will focus on the value of Orthobiologics, patient selection, how to talk to your patients about money, office setup, and other logistics. If this is something you've always wanted but don't know where to start, join me in "The Business of Orthobiologics" podcast.

Dr. Ariana

Hi. I wanted to share with you a script for discussing Orthobiologic treatment consent. So "Hello, Sue. I am Dr. DeMers, and today I want to discuss the orthobiologic treatments that we're considering for you. It's important for you to fully understand what this treatment entails and what to expect. The treatment involves using biologic substances like platelet-rich plasma or stem cell type procedures to promote healing and tissue repair in your body. The main purpose of this treatment is for you to have reduced pain and promote tissue healing. Now, it's crucial for you to be aware of the potential risks associated with this procedure. These risks include the possibility of infection, allergic reactions, limited efficacy, as well as common side effects like pain, swelling, and bruising at the injection site. Before we proceed, I also want to mention that there are alternative treatment options, such as physical therapy, anti-inflammatory medications, and hyaluronic acid injections, and we can discuss these alternatives to help you make an informed decision. The procedure itself will involve some anesthetic, the injection-based procedure under ultrasound guidance, and then post-treatment care and rehab and follow-up. It's important to follow any post-in-treatment instructions carefully for best results, including no anti-inflammatory use for two weeks. Patients who undergo this treatment typically experience reduced pain and improved function, but it doesn't happen right away. There is a period of downtime and a period of increased swelling and inflammation. Additionally, I do want you to know that the procedure will cost $2,000, and you should check with your insurance provider. Most times, this is not covered by commercial insurance, and so this will be an out-of-pocket expense. Do you have any questions or concerns at this point? I just wanted to make sure you're fully informed before we proceed." And then allow the patient to ask any questions and discuss any concerns and address all of their questions and ensure they feel comfortable. "Great. Once you're ready and all your questions have been answered, please sign this consent form. This form confirms that you understand the procedure, and its risks, and that you're providing informed consent to proceed with your pre-treatment." And then ensure that the patient signs the consent form after all the questions have been addressed and you've provided all the necessary information. "Thanks so much, Sue. Thanks for taking the time to go over this process with us today. We wanted you to feel fully informed and ensure that you feel comfortable with your decision. If you have any more questions or concerns in the future, please don't hesitate to reach out." And so this script and consent should help educate your patients and obtain their informed consent for orthobiologic treatments in a compliant matter and a thoughtful, thorough manner. So I'm going to share with you one more script for discussing orthobiologic treatments, including consent for off-label use. "Hello, John, I'm Dr. DeMers, and today I want to discuss with you the orthobiologic treatments that we're considering for you. It's important for you to fully understand what this treatment entails and what to expect. The orthobiologic treatment involves a biologic substance like platelet-rich plasma or cellular therapy to promote healing and tissue regeneration in your body. The main purpose of this treatment is for reducing pain and promoting tissue healing. Now, I need you to be aware that the use of biologic substances in this specific context is considered off-label. And this means while they have been approved for certain medical purposes, their use for your condition may not have been officially approved by the regulatory agencies like the FDA. And it may not be widely accepted as a standard practice. The reason for this off-label use could be because new research has shown potential benefits for your condition, even though it hasn't received formal approval for that use. I want to be transparent about this because it's essential that you fully understand the nature of your treatment. It's also important that, like any medical procedure, you need to understand the potential risks associated with this off-label treatment. These risks include the possibility of infection, allergic reaction, limited efficacy, as well as common side effects like pain, swelling, and bruising at the injection site. Before we proceed, I want to also mention that there are alternative options, such as physical therapy, anti-inflammatory medications, and other FDA-approved medications such as hyaluronic acid. We can discuss these alternatives to help you make your informed decision. The procedure itself will involve a topical anesthetic, as well as an injectable local anesthetic in the skin, ultrasound-guided injection-based therapies of your orthobiologic, and then a very short downtime of approximately 48 to 72 hours, requiring some decrease in your activity level. You may require a short-term narcotic medication and may require crutches or assistive devices. It is important to follow the post-treatment instructions carefully, and we have printed those out for you. Patients who undergo this treatment typically experience reduced pain and improved function, but it doesn't happen right away. Regarding the cost of the procedure, the cost will be about $2,050 and this is typically not covered by insurance so you may want to check with your insurance provider to see if it's covered as there may be out-of-pocket expenses I need you to be aware of. Do you have any questions or concerns at this point? I want to make sure you're fully informed before we proceed." And then allow this time for the patient to ask any questions and discuss any concerns, address their queries, and ensure they feel comfortable. "Great. Once you're ready and all of your questions have been answered to the best of our ability, please sign this consent form. I will have a witness that ensures that you are giving your full consent and this form confirms that you understand the procedure, its risks, the off-label nature of the treatment and that you're providing informed consent to proceed." And then you ensure the patient signs the consent after all the questions have been answered. "Thank you, John, for taking the time to go over this process with us. We want to ensure that you're fully informed and comfortable with your decision. If you have any more questions or concerns in the future, please don't hesitate to reach out." Now, these are scripts that you can use and it may be helpful or beneficial for you to record this for your patient on video format. Additionally, there may be this script that you follow to go through your consent for your orthobiologic procedures. I hope this has been helpful. Thanks.

Outro

This has been "The Business of Orthobiologics" podcast. Thank you so much for joining us today. If you want to know more, please join us on the website "PRP-Now.com" and click on the FREE Masterclass. Also, don't forget to "SUBSCRIBE" to this podcast to get more guidance on integrating PRP in your busy practice. Bye for now.