evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Peripheral Venous Ultrasound (DL33693)
Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, and abdominal aortic): a collaborative report from the American Association of Vascular Surgery/Society for Vascular Surgery, Society of Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines.Circulation. 2006;113(11):e4634.Hwang JY. Doppler ultrasonography of the lower extremity arteries: anatomy and scanning guidelines.Ultrasonography. 2017 Apr;36(2):111-119.Duplex Ultrasound: Medlineplus medical encyclopedia. MedlinePlus. https://medlineplus.gov/ency/article/003433.htm. Updated March 21 2022. Accessed January 12, 2022.Ultrasound- Venous (Extremities). RadiologyInfo.org. https://www.radiologyinfo.org/en/info/venousus. Reviewed February 5, 2019. Accessed February 05, 2019.Kabnick LS, Scovell S. Overview of lower extremity chronic venous disease. UpToDate. https://www.uptodate.com/contents/overview-of-lower-extremity-chronic-venous- disease. Updated September 22, 2020.Mark A, Joseph L. Arterial Diseases of the Extremities. In Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. eds. Harrison's Principles of Internal Medicine, 19e 302:Arterial Diseases of the Extremities. McGraw Hill; 2014.Yadav MK, Mohaammed AKM, Puramadathil V, Geetha D, Unni M. Lower extremities arteries.Cardiovasc. Diagn. Ther. 2019 Aug;9(Suppl 1):S174-S182.Mayo Clinic. Peripheral artery disease (PAD). https://www.mayoclinic.org/diseases- conditions/peripheral-artery-disease/diagnosis-treatment/drc-203505631. 2022.
Proposed LCD - Peripheral Venous Ultrasound (DL33693)
Mayo Clinic. Peripheral artery disease (PAD). https://www.mayoclinic.org/diseases- conditions/peripheral-artery-disease/diagnosis-treatment/drc-203505631. 2022.Patel SK, Surowiec SM. Venous Insufficiency. [Updated 2021 Aug 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from https://www.ncbi.nlm.nih.gov/books/NBK430975/.Varicose Veins- Treatment. NHS. https://www.nhs.uk/conditions/varicose- veins/treatment/. Reviewed May 07, 2020.Deep Vein Thrombosis (DVT). Mayo Clinic. https://www.mayoclinic.org/diseases- conditions/deep-vein-thrombosis/symptoms-causes/syc-20352557. Accessed December 22, 2020.Hirsh J, Hull RD, Raskob GE. Clinical features and diagnosis of venous thrombosis.J Am Coll Cardiol. 1986;8(6 Suppl B):114B-127B.Diagnosis and Treatment of Venous Thromboembolism. Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/dvt/diagnosis-treatment.html. February 07, 2020.Criqui MH, Langer RD, Fronek A, et al. Mortality over a period of 10 years in patients with peripheral arterial disease.N. Engl. J. Med. 1992;326(6):381.Shutze WP, Kane K, et al. The effect of wavelength of endothermal heat-induces thrombosis incidence after endovenous laser ablation.Journal of Vascular Surgery Venous and Lymphatic Disorders. 2016;4(1):36-44.Ryer E, Elmore J, Garvin R, et al. Value of delayed duplex ultrasound assessment after endothermal ablation of the great saphenous vein.Journal of Vascular Surgery, 2016;64(2):446-451.
Proposed LCD - Peripheral Venous Ultrasound (DL33693)
Leng GC, Fowkes FG, Lee AJ, Dunbar J, Housely R, Ruckley CV. Use of ankle pressure index to predict cardiovascular events and death: a cohort study.BMJ. 1996;313(7070):1440.Nicolaides AN; Cardiovascular Disease Educational and Research Trust; European Society of Vascular Surgery; ,The International Angiology Scientific Activity Congress Organization; International Union of Angiology; Union Internationale de Phlebologie at the Abbaye des Vaux de Cernay. Investigation of chronic venous insufficiency: A consensus statement (France, March 5-9, 1997).Circulation. 2000;102(20):E126-E163.McDermott MM, Kerwin DR, Liu K, et al. Prevalence and significance of unrecognized lower extremity peripheral arterial disease in general medicine practice.J Gen Intern Med. 2001;16(6):384390.AbuRahma AF, Adams E, AbuRahma, et al. Critical analysis and limitations of resting ankle-brachial index in the diagnosis of symptomatic peripheral arterial disease patients and the role of diabetes mellitus and chronic kidney disease.J. Vasc. Surg. 2020;71(3):937-945.Hur KY, Jun JE, Choi YJ, et al. Color Doppler Ultrasonography Is a Useful Tool for Diagnosis of Peripheral Artery Disease in Type 2 Diabetes Mellitus Patients with Ankle-Brachial Index 0.91 to 1.40.Diabetes Metab J. 2018;42(1):63-73.Heit J, Spencer F, White R. The Epidemiology of Venous Thromboembolism.J Thromb Thrombolysis. 2016;41(1):3-14.Bell E, Lutsey P, Basu S et al. Lifetime Risk of Venous Thromboembolism in Two Cohort Studies.The American Journal of Medicine, 2016;129(3):339.e19-339.e26.
Proposed LCD - Peripheral Venous Ultrasound (DL33693)
Farah M, Nayfeh T, Urtecho M, et al. A systematic review supporting the Society for Vascular Surgery, the American Venous Forum, and the American Vein and Lymphatic Society guidelines on the management of varicose veins.J Vasc Surg Venous Lymphat Disord. 2022;10(5):1155-1171.Gloviczki P, Lawrence P, Wasan S et al. The 2022 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part I. Duplex Scanning and Treatment of Superficial Truncal Reflux: Endorsed by the Society for Vascular Medicine and the International Union of Phlebology.J. Vasc Surg Venous Lymphat Disord. 2023;11(2):231-261.ACR-SPR-SRU Practice Parameter for the Performing and Interpreting Diagnostic Ultrasound Examinations.American College of Radiology. Revised 2017 (Resolution 32):1-6.
Proposed LCD - Peripheral Venous Ultrasound (DL33693)
American Institute of Ultrasound in Medicine. AIUM Practice Parameter for Documentation of an Ultrasound Examination.2020.J Ultrasound Med;39:E1-E4.
Proposed LCD - Fluid Jet System Treatment for LUTS/BPH (DL38367)
CMS National Coverage PolicyLanguage quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:Title XVIII of the Social Security Act (SSA):Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1862(a)(1)(D) refers to limitations on items or devices that are investigational or experimental.Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.CMS Publications:CMS Publication 100-02,Medicare Benefit Policy Manual, Chapter 14,10 Coverage of Medical DevicesCMS Publication 100-04,Medicare Claims Processing Manual, Chapter 23,30 Services paid under the Medicare Physicians Fee ScheduleCMS Publication 100-08,Medicare Program Integrity Manual, Chapter 13,5.1 Reasonable and necessary provisions in LCDs7.1 Evidence supporting LCDs.Coverage Indications, Limitations, and/or Medical NecessityThis LCD addresses use of the fluid jet system treatment of lower urinary tract symptoms attributable to benign prostatic hyperplasia (LUTS/BPH).IndicationsTreatment for LUTS/BPH will be considered reasonable and necessary when performedONCEin patients with the following:Indications includingALLof the following:
Proposed LCD - Fluid Jet System Treatment for LUTS/BPH (DL38367)
Indications includingALLof the following:Prostate volume of 30-150 cc by transrectal ultrasound (TRUS)1,2Persistent moderate to severe symptoms despite maximal medical management includingALLof the following:International Prostate Symptom Score (IPSS) 121Maximum urinary flow rate (Qmax) of 15 mL/s (voided volume greater than 125 cc)1Failure, contraindication or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride)Only treatment using an FDA approved/cleared device will be considered reasonable and necessary.LimitationsThe following are considered not reasonable and necessary:Body mass index  42kg/m2Known or suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines4) or a prostate specific antigen (PSA) >10ng/mL unless the patient has had a negative prostate biopsy within the last 6 months.Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum3Active urinary tract or systemic infection5Treatment for chronic prostatitis3Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture3Damaged external urinary sphincter3Known allergy to device materials5Inability to safely stop anticoagulants or antiplatelet agents preoperatively.5General InformationAssociated InformationN/ASources of InformationN/ABibliography
Proposed LCD - Fluid Jet System Treatment for LUTS/BPH (DL38367)
Gilling P, Barber N, Bidair, M, et al. Threeyear outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial.Can J Urol.2020;27(1).Desai Mea. Aquablation for benign prostatic hyperplasia in large prostates (80-150cc):2-year results.Can J Urol.2020;27(2):10147-10153.Nguyen DD BN, Bidair M, Gilling P, Anderson P, Zorn KC, et al. Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30-80 and 80-150 mL prostates.BJU Int2020;125(1):112-122.Carroll PR, Parsons JK, Andriole G, et al. NCCN Guidelines Insights Prostate Cancer Early Detection, Version 2.J Natl Compr Canc Netw.2016;14(5):509-519.FDA. FDA Approval: De Nova Classification Request for AQUABEAM System.https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170024.pdf. Accessed accessed 7/2/19.Gilling P, Anderson P, Tan A. Aquablation of the Prostate for Symptomatic Benign Prostatic Hyperplasia: 1-Year Results.Journal of Urology.2017;197(6):1565-1572.Hwang EC, Jung JH, Borofsky M, Kim MH, Dahm P. Aquablation of the prostate for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.Cochrane Database of Systematic Reviews.2019;2:CD013143.Taktak S, Jones P, Haq A, Rai BP, Somani BK. Aquablation: a novel and minimally invasive surgery for benign prostate enlargement.Therapeutic Advances in Urology.2018;10(6):183-188.
Proposed LCD - Fluid Jet System Treatment for LUTS/BPH (DL38367)
Nickel JC, Aaron L, Barkin J, Elterman D, Nachabe M, Zorn KC. Canadian Urological Association guideline on male lower urinary tract symptoms/benign prostatic hyperplasia (MLUTS/BPH): 2018 update.CAn Urol Assoc J.2018;12:303-312.Desai M, Bidair M, Bhojani N, et al. WATER II (80150 mL) procedural outcomes. 2019;123(1):106-112.Chung ASJ, Woo HH. Update on minimally invasive surgery and benign prostatic hyperplasia.Asian Journal of Urology.2018;5(1):22-27.Sturch P, Woo HH, McNicholas T, Muir G. Ejaculatory dysfunction after treatment for lower urinary tract symptoms: retrograde ejaculation or retrograde thinking? .BJU Int2015;115(2):186-197.Zorn KC, Goldenberg SL, Paterson R, So A, Elterman D, Bhojani N. Aquablation among novice users in Canada: A WATER II subpopulation analysis.Canadian Urological Association Journal.2019;13(5):E113-E118.Gilling P, Barber N, Bidair M, et al. WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation vs. Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia.Journal of Urology.2018;199(5):1252-1261.Gilling PJ, Barber N, Bidair M, et al. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes.Urology.2019;125:169-173.Gilling P, Barber N, Bidair M, et al. Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained. 2019;36(6):1326-1336.Desai M, Bidair M, Zorn KC, et al. Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial.BJU International.2019;08:08.
Proposed LCD - Fluid Jet System Treatment for LUTS/BPH (DL38367)
Bhojani N, Bidair M, Zorn KC, et al. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results.Urology.2019;129:1-7.Bach T, Giannakis I, Bachmann A, et al. Aquablation of the prostate: single-center results of a non-selected, consecutive patient cohort.World J Urol.2018.Bach T, Gilling P, El Hajj A, Anderson P, Barber N. First Multi-Center All-Comers Study for the Aquablation Procedure.J Clin Med2020;9(603).Giulio R, Sebastiano C, Giorgio B, et al. Aquabeam System for benign prostatic hyperplasia and LUTS: birth of a new era. A systematic review of functional and sexual outcome and adverse events of the technique.International journal of impotence research.2019:1.Kasivisvanathan V, Hussain M. Aquablation versus transurethral resection of the prostate: 1 year United States - cohort outcomes.Canadian Journal of Urology.2018;25(3):9317-9322.Chughtai B, Thomas D. Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc).Advances in Therapy.2018;35(6):832-838.Yafi FA, Tallman CT, Seard ML, Jordan ML. Aquablation outcomes for the U.S. cohort of men with LUTS due to BPH in large prostates (80-150 cc).International Journal of Impotence Research.2018;30(5):209-214.AUA. Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019, 2020). 2020;https://www.auanet.org/guidelines/benign-prostatic-hyperplasia-(bph)-guideline. Accessed 8/26/2020.
Proposed LCD - Fluid Jet System Treatment for LUTS/BPH (DL38367)
Gravis S, Cornu JN, Gratze, C, et al. EAU Guidelines: Management of Non-neurogenic Male LUTS; Chapter 5: Disease Management. 2019;https://uroweb.org/guideline/treatment-of-non-neurogenic-male-luts/#5. Accessed 9/14/2020.NICE. Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia.https://www.nice.org.uk/Guidance/IPG629. Accessed accessed 8/1/2019.Labban, M., et al., Aquablation for benign prostatic obstruction: Single center technique evolution and experience.Investigative and ClinicalUrology, 2021. 62(2): p. 210.Bach, T., et al., First multi-center all-comers study for the aquablation procedure.Journal of Clinical Medicine, 2020.9(2): p. 603.
Proposed LCD - Trigger Point Injections (TPI) (DL34211)
CMS National Coverage PolicyItalicizedfont represents CMS national language/wording copied directly from CMS Manuals or CMS Transmittals. Contractors are prohibited from changing national language/wording.Title XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Title XVIII of the Social Security Act, 1862(a)(1)(D) Investigational or ExperimentalIOM Citations:CMS IOM Publication 100-08,Medicare Program Integrity Manual,~ Chapter 13, 13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Code for Federal Regulations (CFR) References:CFR, Title 42, Ch. IV, 410.74 Physician assistant's services, 410.75 Nurse practitioner's services and 410.76 Clinical nurse specialist's services.NCDsNCD 30.3.3 Acupuncture for Chronic Low Back PainCoverage Indications, Limitations, and/or Medical NecessityInitial Trigger Point InjectionTrigger point injections (TPI) will be considered medically reasonable and necessary to treat myofascial pain caused by trigger points when all the following requirements are met:There is a focal area of pain in the skeletal muscle.There is clinical evidence of a trigger point defined as pain in a skeletal muscle that is associated with at least 2 of the following findings: the presence of a hyperirritable spot and/or taut band identified by palpation and possible referred painANDThe physical examination identifies a focal hypersensitive bundle or nodule of muscle fiber harder than normal consistency with or without a local twitch response and referred painANDNon-invasive conservative therapy is not successful as first line treatmentORmovement of a joint or limb is limited or blockedORthe TPI is necessary for diagnostic confirmation.
Proposed LCD - Trigger Point Injections (TPI) (DL34211)
Subsequent TPIRepeat Trigger point injections previously injected trigger points will be considered medically reasonable and necessary to treat myofascial pain syndrome when all of the following requirements are met:There is a positive pain response from the most recent TPI defined as providing consistent minimum of 50% relief of primary (index) pain after the TPI measured by the SAME pain scale* at baseline and post-injectionANDConsistent pain relief from the most recent previous TPI lasting at least 6 weeks1ANDThe myofascial pain has reoccurred and is causing objective functional limitations measured by a functional scale obtained at baseline and after TPI which demonstrated at least 50% improvement from the previous TPI.*NOTE: The scales used to measure pain and/or disability must be documented in the medical record. Acceptable scales include but are not limited to: verbal rating scales, Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) for pain assessment, and Pain Disability Assessment Scale (PDAS), Oswestry Disability Index (ODI), Oswestry Low Back Pain Disability Questionnaire (OSW), Quebec Back Pain Disability Scale (QUE), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS), and the PROMIS profile domains to assess function.Limitations: No more than three (3) TPI sessions will be reimbursed per rolling 12 months.Requirements:
Proposed LCD - Trigger Point Injections (TPI) (DL34211)
Patients should be part of an ongoing conservative treatment program and documentation to support the patient is actively participating in a rehabilitation program, home exercise program or functional restoration program is in the medical record.There should be at least 6 weeks duration before TPI is repeated in the same location.Trigger point primary index pain must be measured prior to the injection at the beginning of the session.The post procedure pain level must be measured after the TPI at the conclusion of the session u sing the same scale* utilized at baseline.When documenting the percentage of pain relief from the primary (index) pain compared to the post-injection pain levels, it is insufficient to report only a percentage of pain relief and/or a nonspecific statement of the duration of pain relief. The documentation should include a specific assessment of the duration of relief being consistent or inconsistent with the agent used for the injection and the specific dates the measurements were obtained using the SAME pain scale* used at baseline.When documenting the ability to perform previously painful movements and activities of daily living (ADLs) it is insufficient to provide a vague or nonspecific statement regarding the improvement of previously painful movements and activities of daily living (ADLs). The documentation should include a functional assessment to show clinically meaningful improvement with painful movements and ADLs, if this metric is used to justify the efficacy of the TPI Provider should use established and measurable goals and objective scales to assess functionality and ADLs measures.Limitations:
Proposed LCD - Trigger Point Injections (TPI) (DL34211)
Limitations:A TPI involves the use of local anesthetic and does not include injections of biologicals (e.g., platelet rich plasma, stem cells, amniotic fluid, etc.) and/or any other injectates.It is not considered medically reasonable and necessary to perform TPI into multiple muscle groups in different anatomical regions during the same session.It is not considered medically reasonable and necessary to perform multiple blocks (ESI, sympathetic blocks, facet blocks, etc.) during the same session as TPI.Trigger point injections for treatment of headache, neck pain or low back pain in absence of actual trigger points, diffuse muscle pain, a chronic pain syndrome, lumbosacral canal stenosis, fibromyalgia, non-malignant multifocal musculoskeletal pain, complex regional pain syndrome, sexual dysfunction/pelvic pain, whiplash, neuropathic pain, and hemiplegic should pain are considered investigational and therefore are not considered medically reasonable and necessary.Use of fluoroscopy or MRI guidance for performance of TPI is not considered reasonable and necessary.The use of ultrasound guidance for the performance of TPI is considered investigational.Trigger point injections used on a routine basis, e.g., on a regular periodic and continuous basis, for patients with chronic non-malignant pain syndromes are not considered medically necessary.
Proposed LCD - Trigger Point Injections (TPI) (DL34211)
Provider Qualifications:The Medicare Program Integrity Manual states services will be considered medically reasonable and necessary only if performed by appropriately trained providers.Patient safety and quality of care mandate that healthcare professionals who perform TPI injections/procedures for chronic pain (not surgical anesthesia) are appropriately trained and/or credentialed by a formal residency/fellowship program and/or are certified by either an accredited and nationally recognized organization or by post-graduate training course accredited by an established national accrediting body or accredited professional training program whose core curriculum includes the performance and management of the procedures addressed in this policy. Credentialing or privileges are required for procedures performed in inpatient and outpatient settings.2All aspects of care must be within the provider's medical licensure and scope of practice. Reimbursement for procedures utilizing imaging techniques may be made to providers who meet training requirements for the procedures in this policy only if their respective state allows such in their practice act and formally licenses or certifies the practitioner to use and interpret these imaging modalities (ionizing radiation and associated contrast material, magnetic resonance imaging, ultrasound). At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics as well as proficiency in diagnosis and management of disease, the technical performance, and utilization of the required associated imaging modalities.General InformationAssociated InformationN/ASources of InformationN/ABibliography