evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39575)
Hanselman A.E., Tidwell J.E., Santrock R.D. Cryopreserved human amniotic membrane injection for plantar fasciitis: A randomized, controlled, double-blind pilot study.Foot Ankle Int. 2015;36(2):151-158. doi:10.1177/1071100714552824Matthews M, Betrus CJ, Klein EE, et al. Comparison of Regenerative Injection Therapy and Conventional Therapy for Proximal Plantar Fasciitis.J Foot Ankle Surg. 2022;doi:10.1053/j.jfas.2022.11.010, 10.1053/j.jfas.2022.11.010Nakagawa H, Sung K, Ashkani-Esfahani S, et al. Plantar fasciitis: a comparison of ultrasound-guided fasciotomy with or without amniotic membrane allograft injection.Med. 2022;17(12):931-940. doi:10.2217/rme-2022-0094Werber B: Amniotic tissues for the treatment of chronic plantar fasciosis and Achilles tendinosis.J Sports Med(Hindawi Publ Corp) 2015;2015:219896Lullove E. A flowable placental tissue matrix allograft in lower extremity injuries: a pilot study. 2015;7:e275.Spector JE, Hubbs B, Kot K, et al. Micronized dehydrated human amnion/chorion membrane injection in the treatment of chronic Achilles tendinitis.J Am Podiatr Med Assoc. 2021;111(6)doi:10.7547/19-170, 10.7547/19-170
Proposed LCD - Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39575)
Gomoll A.H., Farr J., Cole B.J., et al. Safety and efficacy of an amniotic suspension allograft injection over 12 months in a single-blinded, randomized controlled trial for symptomatic osteoarthritis of the knee.J. Arthrosc. Relat. Surg.2021;37:22462257. doi: 10.1016/j.arthro.2021.02.044.elik D, oban , Kilioglu . Minimal clinically important difference of commonly used hip-, knee-, foot-, and ankle-specific questionnaires: a systematic review.J Clin Epidemiol. 2019;113:44-57. doi:10.1016/j.jclinepi.2019.04.017McCarthy M Jr, Chang CH, Pickard AS, et al. Visual analog scales for assessing surgical pain.J Am Coll Surg. 2005;201(2):245-252. doi:10.1016/j.jamcollsurg.2005.03.034Landorf KB, Radford JA, Hudson S. Minimal important difference (MID) of two commonly used outcome measures for foot problems.J Foot Ankle Res2010;3(1):7.Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale.Ann Emerg Med2001;38(6):633-638.Alden KJ, Harris S, Hubbs B, et al. Micronized dehydrated human amnion chorion membrane injection in the treatment of knee osteoarthritis  a large retrospective case series.J Knee Surg. 2021;34(8):841-845. doi:10.1055/s-0039-3400951, 10.1055/s-0039-3400951Castellanos R, Tighe S. Injectable amniotic membrane/umbilical cord particulate for knee osteoarthritis: a prospective, single-center pilot study.Pain Med. 2019;20(11):2283-2291. doi:10.1093/pm/pnz143
Proposed LCD - Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39575)
Mead OG, Mead LP. Intra-articular injection of amniotic membrane and umbilical cord particulate for the management of moderate to severe knee osteoarthritis.Res. Rev.2020;12:161170. doi: 10.2147/ORR.S272980.Natali S, Farinelli L, Screpis D, et al. Human amniotic suspension allograft improves pain and function in knee osteoarthritis: a prospective not randomized clinical pilot study.Clin. Med. 2022;11(12)doi:10.3390/jcm11123295,10.3390/jcm11123295Meadows MC, Elisman K, Nho SJ, et al. A single injection of amniotic suspension allograft is safe and effective for treatment of mild to moderate hip osteoarthritis: a prospective study. 2022;38:325331. doi: 10.1016/j.arthro.2021.04.034.Guimaraes JDS, Arcanjo FL, Leporace G, et al Effects of therapeutic interventions on pain due to plantar fasciitis: A systematic review and meta-analysis.Rehabil. 2022;no pagination. doi:10.1177/02692155221143865Zaffagnini M, Boffa A, Andriolo L, et al. Orthobiologic injections for the treatment of hip osteoarthritis: a systematic review.J Clin Med. 2022;11(22):6663. Published 2022 Nov 10. doi:10.3390/jcm11226663Aratikatla A, Maffulli N, Rodriguez HC, et al. Allogenic perinatal tissue for musculoskeletal regenerative medicine applications: a systematic review protocol. J. Orthop. Surg.2022;17(1):307. doi:10.1186/s13018-022-03197-z,10.1186/s13018-022-03197-z
Proposed LCD - Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39575)
Sultan AA, Samuel LT, Roth A, et al. Operative Applications of Placental Tissue Matrix in Orthopaedic Sports Injuries: A Review of the Literature.Surg Technol Int.2019;34:397-402.McIntyre JA, Jones IA, Danilkovich A, Vangsness CT. The placenta: applications in orthopaedic sports medicine.J. Sports Med. 2018;46(1):234-247. doi:10.1177/0363546517697682Tsikopoulos K, Vasiliadis HS, Mavridis D. Injection therapies for plantar fasciopathy ('plantar fasciitis'): A systematic review and network meta-analysis of 22 randomised controlled trials.J. Sports Med. 2016;50(22):1367-1375. doi:10.1136/bjsports-2015-095437Sterne JAC, Savovic J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials.BMJ. 2019;366:l4898. Published 2019 Aug 28. doi:10.1136/bmj.l4898Schnemann H, Brozek J, Guyatt G, Oxman A, editors. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013.The GRADE Working Group, 2013. Available fromorg/handbook.
Proposed LCD - Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH) (DL38378)
CMS National Coverage PolicyN/ACoverage 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).Treatment for LUTS/BPH treatment will be considered reasonable and necessary when performedONCEin patients with the following: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)>10 ng/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 in the Treatment of Benign Prostatic Hyperplasia (BPH) (DL38378)
Gilling P BN, 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 KPJ, 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. 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.Nickel JC AL, 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.
Proposed LCD - Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH) (DL38378)
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 WH, 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.Gilling, P.J., et al.,Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH.Can J Urol, 2022.29(1): p. 10960-10968.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 in the Treatment of Benign Prostatic Hyperplasia (BPH) (DL38378)
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.Thorsten Bach PG, Albert El Hajj, Paul Anderson, Neil Barber. 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.Kasraeian, A., et al.,Aquablation for BPH: United States single-center experience.The Canadian Journal of Urology, 2020.27(5): p. 10379.Labban, M., et al.,Aquablation for benign prostatic obstruction: Single center technique evolution and experience.Investigative and Clinical Urology, 2021.62(2): p. 210.
Proposed LCD - Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH) (DL38378)
Labban, M., et al.,Aquablation for benign prostatic obstruction: Single center technique evolution and experience.Investigative and Clinical Urology, 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.(AUA) AUA. Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019, 2020). 2020. Accessed 8/26/2020.Lerner, L. B., McVary, K. T., Barry, M. J., Bixler, B. R., Dahm, P., Das, A. K., ... & Wilt, T. J. (2021). Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA guideline part IIsurgical evaluation and treatment.The Journal of urology,206(4), 818-826.Gravis S, Cornu JN, Gratze, C, et al. EAU Guidelines: Management of Non-neurogenic Male LUTS; Chapter 5.3: Surgical Management. 2020: Disease Management. 2019. Accessed 9/14/2020.NICE. Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia. Accessed 8/1/2019.
Proposed LCD - Urine Drug Testing (DL36029)
CMS National Coverage PolicyTitle 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.42 CFR 410.32(a). Order diagnostic tests.42 CFR 411.15(k)(1). Particular Services excluded from coverage.CMS On-Line Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.0, 80.1.1, 80.1.2. Clinical Laboratory services.CMS Internet Only Manuals, Pub 100-02 Medicare Beneficiary Policy Manual chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityPurposeUrine drug testing (UDT) provides timely, objective, and actionable information to clinicians by identifying the presence or absence of drugs of potential abuse in the body to assist the clinician in making treatment decisions1.This policy details:The appropriate indications and allowed number of UDTs billed over time for safe medication management of prescribed substances in risk stratified pain management patients and/or in identifying and treating substance use disorders (SUDs);Designates documentation, by the clinician caring for the beneficiary in the beneficiarys medical record, of medical necessity for, and testing ordered on an individual patient basis;Provides an overview of presumptive UDT and definitive UDT testing by various methodologies.This policy addresses UDT for Medicare patients only.DefinitionsAs used in this document, the following terminology relates to the basic forms of UDT:
Proposed LCD - Urine Drug Testing (DL36029)
Presumptive/Qualitative Drug Testing(hereafter called "presumptive" UDT) - Covered when medically necessary to immediately determine the presence or absence of drugs or drug classes in a urine sample; results expressed as negative or positive or as a numerical result; includes competitive immunoassays (IA) and thin layer chromatography2.Definitive/Quantitative/Confirmation(hereafter called definitive UDT) - Covered when clinically indicated and medically reasonable and necessary based on this LCD to identify specific medications, illicit substances, and metabolites; reports the results of analytes absent or present typically in concentrations such as ng/mL; definitive methods include but are not limited to GC-MS and LC-MS/MS testing methods only2.Specimen Validity Testing- Urine specimen testing to ensure that it is consistent with normal human urine and has not been adulterated or substituted, may include, but is not limited to pH, specific gravity, oxidants, and creatinine. This however is quality assurance, not a Medicare benefit, and thus not separately payable by Medicare.Immunoassay (IA)- Ordered by clinicians primarily to identify the presence or absence of drug classes and some specific drugs; biochemical tests that measure the presence above a cutoff level of a substance (drug) with the use of an antibody; read by photometric technology2.Point of Care Testing (POCT)- Covered when medically necessary by clinicians caring for the beneficiary for immediate test results for the immediate management of the beneficiary; available when the beneficiary and physician are in the same location; IA test method that primarily identifies drug classes and a few specific drugs; platform consists of cups, dipsticks, cassettes, or strips; read by the human eye, or read by instrument assisted direct optical observation3.Standing Orders- Test request for a specific patient representing repetitive testing to monitor a condition or disease for a limited number of sequential visits; individualized orders for certain patients for pre-determined tests based on historical use, risk, and community trend patient profiles; clinician can alter the standing order. Note: A profile is developed based on specific characteristics of a specific patient, while a panel is a general non-specific group of tests that may have unnecessary tests for the specific patient being treated.
Proposed LCD - Urine Drug Testing (DL36029)
Blanket Orders- Test request that is not for a specific patient; rather, it is an identical order for all patients in a clinicians practice without individualized decision making at every visit.Reflex Testing- Laboratory testing that is performed "reflexively" after initial test results to identify further diagnostic information essential to patient care. This testing is not necessarily based on a specific physician's order.
Proposed LCD - Urine Drug Testing (DL36029)
Drug Testing MethodsThe Clinical Laboratory Improvement Amendments (CLIA) regulates laboratory testing and requires clinical labs to be certified by their State as well as the Center for Medicare & Medicaid Services (CMS) before they can accept human samples for diagnostic testing3. Multiple types of CLIA certificates may be obtained based on the complexity of testing a lab conducts. CLIA levels of complexity (CLIA-waived, moderate complexity, and high complexity) are addressed only as they correspond to the Healthcare Common Procedure Coding System (HCPCS) code description in the related billing and coding article.A. Presumptive Testing Methods1. Presumptive UDT:A presumptive UDT that consists of various platforms including cards, dipsticks, cassettes, and cups based on qualitative competitive immunoassay methodology with one or more analytes in the test. A presumptive IA test detects the presence of the amount of drug/substance present in urine above a predetermined cut-off value and may be read by direct optical observation or by instrument assisted direct optical observation.A positive test result is reported when the concentration of drug is above the cutoff; a negative is reported when the concentration of drug is below the cut-off. Positive test results are presumptive but not necessarily definitive due to sensitivity and cross-reactivity limitations4. Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen3. The accuracy of the results of a presumptive UDT will depend on the testing environment, type of test, the drug being tested for, and training of the individual conducting the test. This type of test should only be used when results are needed immediately.
Proposed LCD - Urine Drug Testing (DL36029)
2. Presumptive UDT by Instrumented Chemistry Analyzers:Chemistry analyzers with IA UDT technology can be used in an office or clinical laboratory setting. This test provides less immediate test results. At no time is IA technology by chemistry analyzer analysis considered confirmatory (definitive) testing.A presumptive positive IA test detects the presence of a drug/substance in urine at or above the cut-off value. If the concentration of the drug is below the cut-off, the result will be negative. Presumptive positive tests are not always true positives due to sensitivity, specificity, and cross-reactivity limitations. Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen3.Food and Drug Administration (FDA) approved/cleared test platforms are available in the marketplace as well as laboratory developed tests (LDTs) such as modified FDA approved/ cleared and non-FDA approved/cleared platforms and/or reagents. LDTs generally have been modified to test at a lower cutoff in order to detect substances that would have been missed at a higher cutoff. For example, an FDA labeled cutoff may be 300 ng/mL and the LDT cutoff for the same drug may be 100 ng/mL3.Presumptive UDT can be carried out at any validated cut-off concentration. Lowering of the cut-off concentration provides more stringent cutoffs for illicit drugs. LDTs may include non-FDA cleared tests not available in CLIA-waived or moderate complexity tests (e.g., tramadol, tapentadol, carisoprodol, fentanyl, zolpidem). Lowering the cutoff increases the possibility of detecting a drug when the test has been modified from the recipe of the manufacturer.3. Limitations of Presumptive UDT:Presumptive UDT testing is limited due to:
Proposed LCD - Urine Drug Testing (DL36029)
3. Limitations of Presumptive UDT:Presumptive UDT testing is limited due to:Primarily screens for drug classes rather than specific drugs, and therefore, the practitioner may not be able to determine if a different drug within the same class is causing the positive result;Produces erroneous results due to cross-reactivity with other compounds or does not detect all drugs within a drug class5;Given that not all prescription medications or synthetic/analog drugs are detectable and/or have assays available, it is unclear as to whether other drugs are present when some tests are reported as positive;Cut-off may be too high to detect presence of a drug5.
Proposed LCD - Urine Drug Testing (DL36029)
These limitations may mean that presumptive testing is insufficient for certain clinical needs.An IA involves an antibody that reacts best with the stimulating drug and reacts to a lesser extent (cross-reactive) or not at all with other drugs in the drug class. While presumptive tests vary in their ability to detect illicit drugs such as tetrahydrocannabinol (THC), cocaine, 3,4-methylenedioxy-N-methylamphetamine (MDMA; ecstasy), and phencyclidine (PCP), they may not be optimal tests for many prescription drugs, such as: opiates, barbiturates, benzodiazepines, and opioids.For example, opiate reagents are formulated from morphine. Consequently, the cross-reactivity for other opioids and opiates varies based on the manufacturer and lot number. The semisynthetic opioids, hydromorphone and hydrocodone, may contribute to a positive presumptive result, while the semisynthetic opioids, oxycodone and oxymorphone, will not typically be detected even at a 300 ng/mL cutoff. Synthetic opioids, such as fentanyl, meperidine, and methadone, will not be detected by current opiate IA testing. Consequently, a positive opiate result by IA normally necessitates more specific identification of the substance(s) that account for the positive result, and a negative result does not rule out the presence of opiates or opioids6.Presumptive UDT reagents for benzodiazepine are typically formulated for oxazepam, a metabolite of diazepam (Valium) and chlordiazepoxide (Librium), the main benzodiazepines prescribed twenty years ago. However, many of the more than 10 benzodiazepines that are currently available do not cross-react with IA benzodiazepine reagents. In particular, clonazepam and lorazepam give false negative results with presumptive IA tests and may necessitate more specific identification to account for the negative result. Similarly, a positive screening test result may require definitive UDT to identify the specific drug(s).