FAQs about the Acessa™ Procedure
2. IS IT COVERED BY INSURANCE?
● Is it covered by Insurance?
● How can I check if it’s covered by my insurance carrier?
● If it is covered by my insurance carrier, how much will it cost?
● It is not covered by my insurance, is there an appeals process?
● Is there a self-pay option? How much does self-pay cost?
3. WHO IS A CANDIDATE FOR THE PROCEDURE?
● Can Acessa treat large fibroids?
● Is there a limit to the number or quantity of fibroids that can be treated?
● Can Acessa be used to treat any type of fibroid in any location?
● How can I figure out what types of fibroids I have?
● Is there an age limit?
● Is Acessa recommended for women who want to have future pregnancies?
● Have women have gotten pregnant after using Acessa?
4. WHAT IS THE PROCEDURE?
● What is the Acessa Procedure?
● What should I expect the day of surgery?
● What steps are involved in the actual Acessa Procedure?
● If the fibroids are not physically removed, how does Acessa work?
● What happens to the fibroid? How much do they shrink?
● What does laparoscopic mean?
● Am I asleep during the procedure?
● Can the procedure be performed in the office?
● How long does the procedure take?
● Is the Acessa Procedure painful?
5. WHAT INFORMATION IS AVAILABLE ABOUT THE PROCEDURE?
● How safe is the Acessa Procedure? Is it clinically proven?
● What is the difference between Uterine Artery Embolization (UAE) vs Acessa?
● What is the difference between Myomectomy vs Acessa?
7. WHY HAVEN’T I HEARD ABOUT ACESSA BEFORE? WHERE CAN I GET THE PROCEDURE?
● How long has this option been available, and why has my doctor never heard of it?
● Where is the procedure offered in the US?
● Is it offered outside the US?
● I’m from Canada, is there a waitlist I can get added to?
● Are there clinical studies I can join?
● There are no physicians in my area who offer the procedure, what should I do?
● Can my current physician do the Acessa Procedure even if he or she is not on your list?
1) Find an physician who offers Acessa on the Acessa website
2) Call the office to schedule an initial consultation (mention Acessa (“Assess-uh”) on the phone call)
3) During the consultation, discuss whether Acessa as a fibroid treatment option is right for you. If it is, your physician’s office can help you determine insurance coverage or discuss self-pay options.
If you have trouble scheduled an appointment with an Acessa trained physician, you can also reach us at info at acessahealth.com
Is it covered by insurance?
Acessa is covered by many insurance carriers. The first step if you are interested in the Acessa procedure is to contact a physician who offers the Acessa procedure and schedule an initial consultation. After you have a consultation with a physician and determine if you are a candidate for the procedure, their office and the Acessa Insurance Support line can help you understand the benefits and coverage for Acessa. 866-473-4895 Insurance at AcessaHealth.com
How can I check if Acessa is covered by my insurance carrier?
Laparoscopic radiofrequency ablation (Lap-RFA aka Acessa) is becoming a covered benefit by more insurance companies as patients, physicians, employers and insurance companies realize that Acessa is an important option for patients to be able to consider in their quest for the right treatment.
Patients whose insurance companies do not currently cover the procedure have several options to challenge a negative prior authorization decision. The best way to find out if your insurance company covers the procedure is to contact our Insurance Support line. 866-473-4895 Insurance at AcessaHealth.com
It is covered by my insurance, how much will it cost?
We are unable to provide an estimate because every benefit plan is different. Your insurance company and the physician’s office are the best resources to provide a price quote.
It is not covered by my insurance, is there an appeals process?
Note, we have heard from some patients that they have received incorrect information from the insurance call centers. Thus, we suggest scheduling an appointment with an Acessa trained physician and going through the formal process of prior authorization. After the initial consultation, if you are a candidate for the procedure, your physician’s office will submit a pre-authorization to your insurance for the procedure.
If your pre-authorization is denied, we have dedicated Acessa Insurance Support team to help patients with the appeals process. The only way to initiate the appeals process is after you have a consultation with your physician. The appeals process typically takes 2-4 months and does not always result in positive coverage.
Is there a self-pay option? How much does self-pay cost?
Yes, there are physicians who offer cash, self-pay options at ambulatory surgery centers (e.g., typically less expensive than hospitals). The Acessa patient hotline can help you navigate which physicians offer self-pay options.
Based on data on file, the typical range is $9,000 – $15,000. The cost varies by the physician, location (hospital or surgery center) and region. The best way to get self-pricing information is to call your physician’s office and request quote information. For some offices, an initial consult is needed before the office can provide a price quote.
Can Acessa be used to treat any type of fibroid in any location?
Acessa can be used to treat almost all types of symptomatic uterine fibroid types, including subserosal, intramural, transmural, and submucosal. (1) Acessa should not be used on non-uterine masses.
Can Acessa treat large fibroids?
It is your doctor’s decision to decide if he or she can safely and effectively treat your fibroids. The safety and effectiveness of the Acessa procedure has not been evaluated in women with uterine size greater 14 weeks(14) (which roughy equates to a single ~9 cm diameter fibroid)(17,18,19).
Is there a limit to the number or quantity of fibroids that can be treated?
A physician can treat any number of fibroids present(3). The number of fibroids that a physician is able to treat in a single procedure may vary. However, the ability to treat more fibroids thanks to laparoscopic ultrasound image can be an advantage of Acessa compared to myomectomy.(4,12)
How can I figure out what types of fibroids I have?
Typically, physicians determine the type of fibroids and locations using an MRI or transvaginal ultrasound (TVUS), when determining diagnosis and treatment plan. If you have already received an MRI or ultrasound, but do not know what type of fibroids or the location of your fibroids, we encourage you to ask your doctor for a written list of types and locations of the fibroids.
Is there an age limit?
Most women who seek the surgery are pre-menopausal. Acessa studied women 25 years and older. The study population included women up to 55 years old(1). As a reminder, Acessa is a treatment for benign (non-cancerous) symptomatic fibroids. If patients are at risk for cancer, or malignancy, Acessa is not the appropriate treatment.
Is Acessa recommended for women who want to have future pregnancies?
Insufficient data exists to evaluate the safety and efficacy of the Acessa Procedure for women who are seeking future pregnancy. Therefore, the Acessa Procedure is not recommended for women who are planning future pregnancy. (3) Fertility discussions should be had with physicians.
What is the Acessa Procedure?
The Acessa Procedure, also known as laparoscopic radiofrequency ablation (Lap. RFA), is preformed as an outpatient procedure (i.e., go home from the surgery the same-day) under general anesthesia (i.e., patients are asleep during surgery) to treat symptomatic uterine fibroids. It is a minimally invasive alternative to hysterectomy, myomectomy and uterine artery embolization (UAE) for uterine fibroids.(9) Acessa utilizes radiofrequency ablation (heat) under laparoscopic ultrasound guidance to shrink the fibroid, without disrupting normal uterine tissue(10). The Acessa Procedure allows the physician to treat almost all types of fibroids.(3,9) See “How does the Acessa procedure work?” for more information on how the procedure works.
Radiofrequency ablation is a technique used in other procedures to destroy cell tissue.
What should I expect the day of surgery?
● After arriving at the hospital or surgery center, the nurses will prep the patient for surgery and be brought to the operating room.
● In the operating room, an anesthesiologist will give the patient medicine to fall asleep – general anesthesia.
● The surgery team will prepare the patient and the instruments for surgery and begin the procedure.
● The procedure starts with two small incisions in the abdomen. One in the belly button, then a second at the bikini line. The incisions are typically less than 1/4 of an inch in diameter. These are the access points the surgeon will use for his or her instruments. Then, the surgeon will make a third, percutaneous, insertion through the abdomen for the Acessa handpiece. Again, the patient will be asleep for all of this.
● The surgeon will primarily use four sterilized instruments:
o Acessa Transducer probe – an ultrasound probe that is used to see inside the uterus to find fibroids. The Acessa transducer probe is integrated in the Acessa system and designed specifically for this procedure.
o Acessa Handpiece – a handpiece with a needle-like tip that is inserted percutaneously through the a set of disposable grounding pads that are placed on the patient’s thighs that provide a return path for applied energy.
▪ NOTE: There is a small risk of skin burns from the dispersion of RF energy; however, the use of electrode pads helps to disperse radiofrequency energy from the Acessa ProVu generator to the Acessa Handpiece through the body of the patient. This helps to minimize the risk of burns.(3)
● After the ablating the fibroids, the surgeon will coagulate the access point of the fibroids.
● When he or she completes treating identified fibroids, the surgeon will close the small incisions on the stomach using stitches. Patients will still be asleep under general anesthesia.
● After waking up, patients typically do not feel post-operative pain. Most patients stay at the hospital or surgery center for 1.5-2 hours before returning home. Cramping or pelvic pain may be experience following the procedure and is often managed by the use of non-steroidal anti inflammatory drugs (NSAID) or other analgesic medications.(1,14)
● The surgeon will speak with the patient or patient’s family about the surgery and discuss next steps.
● In clinical studies, patients were able to return back to work and normal activity within 5 days.(3,6,9)
Results may vary.
What steps are involved in the actual Acessa procedure?
Using the three instruments previously discussed, the surgeon treats each fibroid individually with radiofrequency energy (heat) that is specifically controlled to destroy the fibroid tissue with the goal of leaving the surrounding tissue unharmed.
The Acessa Procedure involves three basic steps:
(1) Two small incisions and a percutaneous insertion of the handpiece
a. Two small incisions are made in the abdomen, typically less than ¼” in diameter in the belly button, then a third percutaneous insertion of the handpiece at the bikini line.
(2) Identify fibroids
a. A laparoscopic camera is inserted.
b. A laparoscopic ultrasound probe is used to determine the location and size of all fibroids present.
(3) Destroy fibroid tissue
a. The Acessa handpiece needle is advanced into the fibroid using ultrasound guidance.
b. The electrode array on the tip of the handpiece is deployed into the fibroid.
c. Energy is applied into the fibroid and destroys the fibroid tissue.
d. The surgeon alternates between scanning the uterus with the transducer and ablating tissue with the handpiece needle until all identified fibroids have been treated.
If the fibroids are not physically removed, how does Acessa work?
As a reminder, Acessa is a treatment for benign (non-cancerous) symptomatic fibroids. If patients are at risk for cancer, or malignancy, Acessa is not the appropriate treatment.
Studies show that fibroids do not have to be completely removed to resolve symptoms.(1,8) Treating the fibroid cells so they shrink and stop putting pressure on the uterus may help to resolve symptoms. The data in the IDE clinical study showed even a 45.1% average shrinkage in fibroid volume can result in significant improvement in heavy periods, pelvic pain and bulk. (1)
To summarize, Acessa works by heating the fibroid cells from the inside out, not by removing the fibroid. Cell tissues die when they reach a certain temperature. Acessa is designed to heat the fibroid tissue to the point that the tissue dies. The dead fibroid tissue shrinks and shrivels over time. The dead fibroid tissue is not harmful. It gets absorbed by the body, just like any dead tissue cell.( 3)
What happens to the fibroid? How much do they shrink?
Once the fibroid is treated, the destroyed fibroid tissue shrinks over time. Total volume shrinkage is dependent on fibroid size and location. From the pivotal trial across 135 patients, there was an average of 45.1% decrease in fibroid volume at 12 months after the procedure(1). Fibroids may continue to shrink after 12 months; however, results vary.(1)
What does laparoscopic mean?
Laparoscopic surgery is a minimally invasive surgical technique where surgical tools are operated through small keyholes in the body and a camera (laparoscope) is used to see inside the body. Laparoscopic means there are only small incisions compared to an open procedure where the surgeon cuts a longer incisions.
Can the procedure be performed in the office?
No, the procedure cannot be performed under local anesthesia nor in an office setting. Most office procedures do not have the ability to visualize and treat a wide variety of size, location and number of fibroids. Acessa can be performed at an Ambulatory Surgery Center or a hospital.
How long does the procedure take?
Each procedure varies in length based on the number and size of fibroids. Typically, the entire procedure from anesthesia to waking up lasts 1-2 hours .(7) It may take longer for more fibroids or complications. Results may vary.
Is the Acessa Procedure painful?
Patients may experience cramping or pelvic pain following the procedure. Typically, patients go home on a NSAIDs such as Tylenol and are able to return to normal activity in 4-5 days. (6) Results may vary. Patients should discuss the Acessa procedure including its risks and benefits with their physician.
How safe is the Acessa Procedure? Is it clinically proven?
The idea for laparoscopic RFA was first conceived by Dr. Bruce Lee in 1999. (2) The original Acessa System was cleared for use by the Food and Drug Administration (“FDA”) in November 2012. Since 2012, physicians have performed over 3,500 procedures to date.(5) The newest, most advanced technology, the Acessa ProVu system, received clearance in 2018.
The Acessa procedure is clinically proven. There are over 40 peer-reviewed studies that show Acessa as a clinically proven for the treatment of uterine fibroids. (1,5,8,9) Your physician can explain the potential complications of the Acessa Procedure, as well as those of the other available fibroid therapies.
A meta analysis published in 2019 across 8 studies and 581 patients concluded, “laparoscopic radiofrequency ablation therapy is an efficacious way to treat small-sized and nonpedunculated symptomatic uterine fibroids, providing stable long-term symptom relief and quality of life improvement with a low risk of adverse events and reintervention and just a few days of missed work.”(9).
What is the difference between Uterine Artery Embolization (UAE) vs Acessa?
UAE involves ischemic necrosis which consists of the tissue slowly dying due to lack of blood supply and typically involves an overnight stay for pain management.(13,7) Acessa uses coagulative necrosis which destroys the fibroid cells and nerve endings with heat right away and results in the reduction of the fibroid volume over time.(1)
UAE is performed by interventional radiologists. The Acessa procedure is performed by minimally invasive gynecologic surgeons.(13)
What is the difference between Myomectomy vs Acessa?
Myomectomy involves cutting fibroids and removing the fibroid tissues from the uterus.(13) Acessa, by comparison, does not require cutting or suturing within the uterus.(3) Myomectomy is often considered a minimally invasive surgery because the incisions into the abdomen can be small. Acessa may be a less invasive option because there are zero incisions on the uterine surface (serosa) that require suturing, and only 2 to 3 small incision on the skin (myomectomy has 4 to 6 incisions in the skin).
What are the typical results?
The results of the Overall Treatment Effect Survey of the Pivotal study of 124 patients showed that 94% of the subjects responded that they were very satisfied, moderately satisfied, or somewhat satisfied with the treatment. At 12‐months post-treatment, 98% of the subjects reported that they would probably or definitely recommend the procedure to their friends with the same health problem. When asked about the effectiveness of the treatment, at least 94% of the subjects responded that the treatment had been somewhat, moderately, or very effective in eliminating their symptoms.(1)
Most patients report they have significantly lighter periods and alleviated pelvic pain and pressure. Often patients who experience “bulking” – looking pregnant/ distended abdomen from the fibroids, report reduced or eliminated bulk symptoms.(1) However, results may vary. To hear directly from patients, search “Acessa” on YouTube.
Will patients feel symptom relief?
Based on our clinical data, the average reduction in menstrual blood loss was 87 mL less blood than baseline periods after 3 months and reduced even further to 103.6 mL less by 6 months.(1)
Most patients see the greatest effects 3-6 months after Acessa. (1,6) However, results may vary.
To hear directly from patients, search “Acessa” on YouTube.
How long has this option been available, and why has my doctor never heard of it?
The idea for laparoscopic RFA was first conceived by Dr. Bruce Lee in 1999.(2) After many successful clinical studies, the original Acessa System was FDA cleared in November 2012. Since 2012, physicians have performed over 3,500 procedures to date.(5) The newest, most advanced technology, the Acessa ProVu system, was cleared in 2018.
One of the reasons patients may have not heard about Acessa, is because some insurance companies do not cover the procedure. We are working on changing that. As we receive more coverage we will expand to new areas.
We are on a mission to give women more options. Thankfully, more and more physicians are learning about Acessa, and we are growing daily.
Minimally invasive gynecologic surgeons across the United States offer the procedure. We encourage you to call their offices, mention you found them through the Acessa website and make an appointment. See the list of surgeons who offer Acessa here www.acessaprocedure.com
Is it offered outside the US?
The Acessa procedure is not currently offered outside of the US. However, there is a clinical study ongoing in Germany. Find out more at clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT03028610
I’m from Canada, is there a waitlist I can get added to?
The Acessa Procedure for symptomatic fibroids is not offered in Canada at this time. Acessa Health intends to submit necessary regulatory required data to be evaluated by Health Canada in the near future.
Are there clinical studies I can join?
The studies that continue to enroll using Acessa Technology are:
● United States – https://clinicaltrials.gov/ct2/show/NCT02100904
● Germany – https://clinicaltrials.gov/ct2/show/NCT03028610
You should discuss whether you may be eligible for enrollment with your physician.
Some physicians are accustomed to working with patients who are traveling. If you are interested in traveling for the procedure, we recommend reaching out to any Acessa trained physician’s office to learn more about their policies and your insurance coverage in that city or the patient hotline.
Can my current physician do the Acessa Procedure even if he or she is not on your list?
Most patients choose to see another physician who offers Acessa for their surgery, and then they return to their original OBGYN for ongoing care. If your doctor has never heard of the Acessa procedure for fibroids, we encourage you to tell them about the procedure. We would be happy to train your physician if they have proper training in minimally invasive surgery. However, please note that not all OBGYN physicians are trained in minimally invasive surgery. Thus, not all OBGYN’s will be able to offer the Acessa procedure. If your physician is interested in being trained on the procedure, please have him or her reach out to Acessa Health at info at acessahealth.com.
LEGAL DISCLAIMER: Acessa Health encourages patients to seek medical attention for typical and atypical symptoms associated with fibroids to help achieve and maintain good health with as high a quality of life as possible. Although many patients may benefit from the Acessa Procedure, this treatment is not for everyone and results may vary. You should talk to your doctor about the potential benefits and risks and whether this treatment is right for you. Information contained on this site is not to be used as a substitute for talking to your doctor. You should always talk to your doctor bout diagnosis and treatment information.
REIMBURSEMENT DISCLAIMER: Reimbursement information is provided for convenience only and is not legal advice or official guidance from payers. It is not intended to increase or maximize reimbursement by any payor. Hospitals and physicians are solely responsible for being in compliance with Medicare and other payor rules and requirements for the information submitted with all claims and appeals. Acessa Health, Inc. does not warrant or guarantee that the use of this information will result in coverage or payment. Before any claims or appeals are submitted, hospitals and physicians should review official payor instructions and requirements, should confirm the accuracy of their coding or billing practices with these payors and should use independent judgment when selecting codes that most appropriately describe the services or supplies provided to a patient. CPT five-digit numeric codes, descriptions, and numeric modifiers are © 2020 AMA. All rights reserved.
RISK STATEMENT: The Acessa ProVu system is cleared by the FDA for the treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The Acessa procedure is generally safe but complications may occur and can be serious. Risks and complications associated with the Acessa procedure include, but are not limited to: skin burns from the dispersion of radiofrequency energy, mild intra‐operative bleeding, transient urinary retention or urinary tract infection, adhesion formation, post‐procedural discomfort (cramping, pelvic pain), and transient amenorrhea, infection, injury to adjacent structures, vaginal bleeding and temporary anemia, blood loss requiring transfusion or hysterectomy, pneumothorax, wound dehiscence, deep vein thrombosis and pulmonary embolus, treatment failure, and complications related to laparoscopy and/or general anesthesia including death. Insufficient data exist on which to evaluate the safety and effectiveness of Acessa procedure in women who plan future pregnancy. Therefore, the Acessa procedure is not recommended for women who are planning future pregnancy. There is limited data regarding pregnancy following the Acessa procedure, if you become pregnant following the Acessa procedure, you should contact your doctor immediately. Please consult with your doctor to understand the risks and benefits of surgery and find out if Acessa may be right for you. Rx Only.
1. SG Chudnoff, et al. Outpatient Procedure for the Treatment and Relief of Symptomatic Uterine Myomas. Obstetrics and Gynecology, 2013;121(5):1075–82.
2. Interviews with Dr. Bruce Lee, inventor of the idea of using laparoscopic radiofrequency ablation for fibroids
3. Acessa ProVu Instructions for Use, ProVu Users Guide PL-01-0040
4. Marcel Grube, MD, Felix Neis, MD, Sara Y. Brucker, MD, Stefan Kommoss, PhD, Martin Weiss, MD, Sascha Hoffman, MD, Florin-Andrei Taran, MD, Bernhard Krämer, PhD. Uterine fibroids: current trends and strategies. Surg Technol Int. 2019 Mar 18:34. PMID: 30888674
5. Acessa Health Corporate data, proprietary system
6. R Robles, V Aguirre, Al Argueta, MR Guerrero, Laparoscopic radiofrequency volumetric thermal ablation of uterine myomas with 12 months of follow-up, Int J Gynecol Obstet 2013; 120:65-9
7. Braun, K. M., Sheridan, M., Latif, E. Z., Regush, L., Maksymowicz, A., Weins, L., … Sanders, B. H. (2016). Surgeons’ early experience with the Acessa™ procedure: gaining proficiency with new technology. International journal of women’s health, 8, 669–675. doi:10.2147/IJWH.S119265
8. Linda D Bradley, MD, Resad P. Pasic, MD, Larry E Miller, PhD. Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies. J Laparoendosc Adv Surg Tech A 2019 Nov 8; doi:10.1089/lap.2019.0550
9. Leteo Lin, MD, Haocheng Ma, MD, Jian Wang, MD, Haitao Guan, MD, Min Yang, MD, Xiaoqiang Tong, MD and Yinghua Zou, MD. Quality of life, adverse events and reintervention outcomes after radiofrequency ablation for symptomatic uterine fibroids: a meta-analysis. J Minim Invasive Gynecol 2019;26(3):409-416. Doi:10.1016/j.jmig.2018.09.772: PMID: 30253997
10. Yelena Havryliuk, MD, Robert Setton, MD, John Carlow, EdD, MPH, Barry D. Shaktman, MD, Management of symptomatic fibroids: review and meta-analysis of the literature (2006 -2016), Journal of the Society
of Laparoendoscopic Surgeons, Vol. 21 (3) Jul-Sept 2017
11. Jay M. Berman, MD, Richard S. Guido, MD, José Gerardo Garza Leal, MD, Rodolfo Robles Pemueller, MD, Fredrick S. Whaley, PhD, Scott G. Chudnoff, MD, MS, Three years’ outcome from the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of ,yomas, The Journal of Minimally Invasive Gynecology 2014; 21(5):767.
12. Sara Y. Brucker, Markus Hahn, Dorit Kraemer, Florin Andrei Taran, Keith B. Isaacson, Bernhard Krämer. Initial results from a randomized controlled study of laparoscopic radiofrequency volumetric thermal ablation of fibroids and laparoscopic myomectomy, International Journal of Gynecology and Obstetrics 2014 available online at http://authors.elsevier.com/sd/article/S0020729214001040
13. Mayo Clinic – Uterine Fibroids – www.mayoclinic.org/diseases-conditions/uterine-fibroids/symptoms-causes/syc-20354288
14. Acessa ProVu Instructions for Use, ProVu Users Guide PL-01-0040
15. Leppert PC, Jayes FL, Segars JH. The extracellular matrix contributes to mechanotransduction in uterine fibroids. Obstet Gynecol Int. 2014;2014:783289. doi:10.1155/2014/783289
16. Lee BB, Yu SP. Radiofrequency Ablation of Uterine Fibroids: a Review. Curr Obstet Gynecol Rep. 2016;5(4):318–324. doi:10.1007/s13669-016-0183-x
17. Sheth, S. S., Hajari, A. R., Lulla, C. P., and Kshirsagar, D. ( 2017) Sonographic evaluation of uterine volume and its clinical importance. J. Obstet. Gynaecol. Res., 43: 185– 189. doi: 10.1111/jog.13189.
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19. Internal analysis using Sheth and Goldstien articles to estimate fibroid size of 14 week uterus