The recommendations are based on limited data. MPTAC review. However, EBRT has been shown to be ineffective in approximately 20-30% of cases and pain recurs in 27% of the treated population (Liberman, 2009). 510K Premarket notification. Albisinni S, Aoun F, Bellucci S, et al. The Summary of Benefits and Coverage (SBC) document will help you choose a health plan. Bone metastasis: When cancer cells have broken off from the primary tumor and have settled and started growing on bones. A total of 29 individuals underwent a follow-up biopsy, either at 12 months only, or at 12 and 36 months. The benefits and limitations of ultrasonography should be discussed with all patients. Visit our official site today for more details. Updated: June 16, 2022. 2011; 3(3):329-338. TULSA was developed as an alternative method of prostate tissue ablation. The single-arm, prospective, multi-center pivotal trial, TULSA-PRO Ablation Clinical Trial (TACT), enrolled 115 individuals with intermediate risk (67.0%) or low risk (33.0%) organ confined prostate cancer who underwent whole gland prostate ablation (Klotz, 2021). In a statement, Anthem says, "Anthem health plans cover 222 contraceptive products at $0 cost share on our ACA Preventive List." The company went on to say that it covers "at least one product" in . Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. Updated Discussion/General Information, References and Websites for Additional Information sections. You bet! Breast MRI costs an average $615 under Medicare . Updated Description, Discussion and References sections. Available at: Antepartum Fetal surveillance. Indiana Medicaid. Updated Coding section to include ICD-10-CM diagnosis codes Z36.0-Z36.9. Treatment of localized prostate cancer using high-intensity focused ultrasound. The new Multiple Delivery policy has the same . Available at: Centers for Medicare and Medicaid Services. MPTAC review. MR-guided focused ultrasound (MRgFUS) ablation for the treatment of nonspinal osteoid osteoma: a prospective multicenter evaluation. 2010; 17(8):715-719. In addition, eligible participants reported a numerical rating scale (NRS) pain score of 4 or greater in spite of maximal pain medication therapy, and a score of 7 or less on the Mirels fracture risk scale. 2017. The treatment group reported an AE frequency of 76.2% versus 23.8% in the sham group. Participants included those who could not undergo or refused all other available options for pain palliation. However, comparisons involving HIFU were limited to radical prostatectomy because of a lack of studies comparing HIFU to other therapies. At various gestational ages, ultrasound examination is an accurate method of determining gestational age, fetal number, viability, and placental location, and it is recommended for all pregnant patients. CPT codes Dx codes 76801 76802 D25, D25.0, D25.1, D25.2, D25.9, O0900, O0901, O0902, O0903, O09511, O09512, June 2021. The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Poggenpoel EJ, Geerts LT, Theron GB. An mpMRI, a transrectal ultrasound guided biopsy and a cystoscopy were performed at 12 months post-procedure. In some states, insurance must cover . Eur Urol. HIFU was comparable to the median survival in standard chemotherapy. Muto S, Yoshii T, Saito K, et al. Evaluate for threatened, incomplete, or missed abortion; Non-reassuring fetal heart rate monitoring; Assess amniotic fluid volume in post-term gestation. The American College of Obstetricians and Gynecologists (ACOG) 2018 Practice Bulletin Ultrasound in Pregnancy lists the following recommendations: The following conclusions are based on good and consistent evidence (Level A): The following conclusions are based on limited or inconsistent evidence (Level B): The following conclusion and recommendation are based primarily on consensus and expert opinion (Level C): The American College of Radiology (ACR), the American Institute of Ultrasound in Medicine (AIUM), ACOG, the Society for Maternal Fetal Medicine (SMFM), and the Society of Radiologists in Ultrasound (SRU) practice parameter (2018) notes: A standard obstetrical ultrasound examination in the first trimester includes evaluation of the presence, size, location, and number of gestational sac(s). Approximately 98% of subjects received 1 (60%) or 2 treatments (38%). J Urol. 2021; 35(4):497-505. That coverage comes at a cost, however; specifically, Plan F is the most expensive of all the MedSup policies on the market today. Dupr A, Melodelima D, Prol D, et al. Pregnant Women. CA/LG/Anthem PPO HSA/H 2000/3000/4000 20/40/73A3/01-23 Page 1 of 11 Summary of Benefits and Coverage: What this Plan Covers & What You Pay for Covered Services Anthem BlueCross Coverage for: Individual + Family | Plan Type: PPO + Anthem PPO HSA/H 2000/3000/4000 20/40 HSA . When services are Medically Necessary for routine anatomy screen and dating when criteria are met: Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation, first trimester (< 14 weeks, 0 days), transabdominal approach; single or first gestation/each additional gestation [includes codes 76801, 76802], Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation, after first trimester (> 14 weeks 0 days), transabdominal approach; single or first gestation/each additional gestation [includes codes 76805, 76810], Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation plus detailed fetal anatomic examination, transabdominal approach; single or first gestation/each additional gestation [includes codes 76811, 76812], Ultrasound, pregnant uterus, real time with image documentation, limited (eg, fetal heart beat, placental location, fetal position and/or qualitative amniotic fluid volume), 1 or more fetuses, Ultrasound, pregnant uterus, real time with image documentation, follow-up (eg, re-evaluation of fetal size by measuring standard growth parameters and amniotic fluid volume, re-evaluation of organ system(s) suspected or confirmed to be abnormal on a previous scan), transabdominal approach, per fetus, Ultrasound, pregnant uterus, real time with image documentation, transvaginal. It is likely that both of these treatment effects contribute to pain relief. Urol Oncol. Postpartum hemorrhage. In 2015, The U.S. Food and Drug Administration (FDA) approved two devices for use in prostate cancer. 2021: S1078-1439(21)00173-3. There were no new reported serious AEs. MedlinePlus. The mean follow-up period was 6.4 years (range, 0.2-13.9). This prospective case series did not compare HIFU long-term survival and morbidity rates with the rates of other standard treatments. ACOG Practice Bulletin Number 229. Added medically necessary indication when there is a known or suspected exposure to the Zika virus to the Clinical Indications section. 2011; 185(3):862-868. The authors noted that incomplete tumor ablation could be related to poor accuracy in determining the target area or movement during the procedure. This document addresses the use of maternity ultrasound in the outpatient setting. Reapproved June 16, 2020. Clin Oncol (R Coll Radiol). J Endourol. The feasibility and safety of high-intensity focused ultrasound as salvage therapy for recurrent prostate cancer following external beam radiotherapy. Salvage high-intensity focused ultrasound for patients with recurrent prostate cancer after brachytherapy. No ionizing radiation (x-ray) is used in ultrasound imaging. Before you decide to pass on Plan F, though, do your due diligence and see how much the insurance . Ahmed HU, Cathcart P, McCartan N, et al. . November 17, 2019. 2014; 96(9):743-751. Available at: High Intensity Ultrasound System For Prostate Tissue Ablation (Focal One). J Urol. Therapies for clinically localized prostate cancer [Internet]. Uchida T, Ohkusa H, Nagata Y, et al. ACR Appropriateness Criteria. Salvage magnetic resonance imaging-guided transurethral ultrasound ablation for localized radiorecurrent prostate cancer: 12-month functional and oncological results. Errico A. 2014; 2014:186782. ultrasound). HIFU or MRgFUS has also been studied as a potential treatment of various cancers. Bertrand AS, Iannessi A, Natale R, et al. Available at: U.S. National Library of Medicine. Rischmann P, Gelet A, Riche B, et al. These results were not included in the primary efficacy analysis. This document addresses ultrasound ablative therapy for the treatment of oncologic conditions. The guideline addresses several non-extirpative therapies and concluded that these therapies, including HIFU, are investigational for the treatment of renal masses. For other common visits, this is what you'll pay with PPO. However, residual tumors of less than 10% were found in 29.4% of cases and residual tumors between 10-90% were found in 22.7% of cases. The primary endpoint was achieved in 96% (110/115) of participants. There is insufficient evidence to draw conclusions about the effect of HIFU on urinary incontinence, erectile dysfunction or fecal incontinence when compared to radical prostatectomy. Salvage high-intensity focused ultrasound (HIFU) for locally recurrent prostate cancer after failed radiation therapy: Multi-institutional analysis of 418 patients. Medicare Supplement Plan F is great because it provides the most coverage of the 10 currently available MedSup plans. (i.e. HIFU has been proposed as a treatment for multiple oncologic conditions. 2002; 59(3):394-398. Prostate Cancer (V1.2023). Transrectal high-intensity focused ultrasound using the Ablatherm device in the treatment of localized prostate carcinoma. MPTAC review. The primary endpoint was the proportion of individuals who achieved a 75% or greater reduction in PSA at 12 months post-procedure. BJU Int. December 2016. MPTAC review. The SBC shows you how you and the Urology. The bone metastases arose from a variety of primary tumors including renal, colorectal, lung, breast and prostate. Clin Orthop Relat Res. We reserve the right to review and update Clinical UM Guidelines periodically. Grade 3 (n=1) and grade 2 (n=3) AEs related to urinary retention and urinary tract infection were reported. By March 2018, Anthem (Blue Cross/Blue Shield) will require that MR and CT scans considered "not medically necessary" be performed at freestanding medical imaging facilities in order to be covered. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. See the following related document for HIFU treatment non-oncologic indications: For information regarding other palliative treatments of metastatic bone lesions, please see the following: Metastatic lesions located 1 centimeter (cm) or greater from skin and major nerve bundles; Individual does not present an increased risk of fracture from the procedure (for example, a score of 7 or less on Mirels fracture risk score); Individual does not require surgical stabilization or have clinically significant comorbidities; Individual is not a candidate for other therapies as evidenced by pain refractory to previous radiation therapy. In 2016, ACOG and the SMFM released a practice advisory regarding the current information and recommendations regarding the Zika virus. Summary of Safety and Effectiveness Data (SSED). Salvage radical prostatectomy following primary high intensity focused ultrasound for treatment of prostate cancer. New reimbursement policy: Maternity Services and Multiple Delivery (Professional) Beginning with dates of service on or after December 1, 2019, Anthem's current Routine Obstetrics policy will be retired and will be replaced by the new Maternity Services policy and the new Multiple Delivery policy. Ahmed HU, Freeman A, Kirkham A, et al. The SBC shows you how you and the plan would share the cost for covered health care services. They determined that Cloyd had ovarian cysts, not appendicitis. Pain severity was measured using a 10-point pain scale questionnaire. The current standard treatment is external beam radiation therapy (EBRT). Br J Surg. The clearance was based upon the Ablatherm device as the predicate device. Guillaumier S, Peters M, Arya M, et al. Ultrasound is currently being used as a therapeutic treatment, for example, lithotripsy to disintegrate kidney stones. 2015; 28(3 Suppl):1097-1100. For instance, if you want to take advantage of inversion therapy, massage, ultrasound therapy, or computer-assisted adjustments, youll need to ask your insurance company about the availability of coverage for these things . 2017; 3:CD012600. Blana A, Murat FJ, Walter B, et al. HIFU has been evaluated as a minimally invasive treatment of whole gland or a focal treatment of prostate cancer, both in the initial treatment of clinically localized prostate cancer and following recurrence. Updated Discussion and References section. Updated Coding section with 10/01/2022 ICD-10-CM changes; added O35.00X0-O35.9XX9 replacing O35.0XX0-O35.9XX9. Routine ultrasound in late pregnancy (after 24 weeks' gestation). Guidelines for diagnostic imaging during pregnancy and lactation. Whole-gland salvage high-intensity focused ultrasound therapy for localized prostate cancer recurrence after external beam radiation therapy. The TULSA-PRO (Profound Medical Corp., Fort Myers, FL) received 510(k) clearance by the FDA in 2019. Cochrane Database Syst Rev. Eur Radiol. Eur Urol. September 15, 2017. This study was a retrospective case series involving 804 subjects who underwent HIFU and were included in an industry-sponsored registry. Alternatively, the reduced tumor mass caused by thermal ablation may have an analgesic effect. A second systemic review in which HIFU was compared to other ablative therapies in the treatment of locally advanced pancreatic cancer was done by Rombouts and colleagues (2015). Kenkhuis MJA, Bakker M, Bardi F, ET AL. Available at: Centers for Disease Control and Prevention (CDC). Ultrasound examinations can be used to assess fetal anatomy, particularly neuroanatomy, and to monitor growth. Kanthabalan A, Peters M, Van Vulpen M, et al. Prostate Cancer Prostatic Dis. Nat Rev Clin Oncol. Sonablate was classified as a class II device. Improved outcomes with advancements in high intensity focused ultrasound devices for the treatment of localized prostate cancer. Anttinen M, Mkel P, Viitala A, et al. Prudent use and safety diagnostic ultrasound in pregnancy. P110039. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. 2012; 116(3):201-205. Bricker L, Medley N, Pratt JJ. Federal and State law, as well as contract language, and Medical Policy take precedence over Clinical UM Guidelines. On October 9, the FDA granted de novo clearance to SonaCare Medical, LLC (Charlotte, NC) to market the Sonablate 450 for prostate tissue ablation. In brief: classifications in brief: Mirels' classification: metastatic disease in long bones and impending pathologic fracture. When services are Not Medically Necessary:For the procedure and diagnosis codes listed above when criteria are not met or for all other diagnoses not listed; or when the code describes a procedure or situation designated in the Clinical Indications section as not medically necessary. 2009; 16(1):140-146. J Ultrasound Med 2013; 32(6):1083-1101. 2016; 19(3):311-316. Hematology/Oncology Subcommittee review. Updated Discussion, References and Websites for Additional Information sections. 2007; 177(6):2106-2131. 2015; 62(137):140-143. Available at: Centers for Disease Control and Prevention (CDC): How is Prostate Cancer Treated? BJU Int. This study was defined by the regulatory agency to evaluate the effectiveness of the device to ablate prostate tissue. First analysis of the long-term results with transrectal HIFU in patients with localised prostate cancer. 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