evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39118)
The Food and Drug Administration (FDA), under Sect. 361 of the Public Health Service Act (regulated by the Centers for Biologics Evaluation and Research CBER, an arm of the FDA) oversees the therapeutic use of Human cells or tissue products or HCT/Ps. Once these types of products are harvested, their process and handling will determine whether the products fall under Section 361 guidance or default to the more regulated section 351 of the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act. The regulatory pathway for pre-market FDA approval of new drugs, devices and/or biological products, requires registration as a (NDA) New Drug application, an (IND) Investigational New Drug application, or a (BLA) Biologics License Approval.8,9,12,13If a human cells or tissue product should meet Section 361 FDA requirements, the product will not require FDA pre-market review and approval. To meet Section 361 FDA regulatory requirements, the placental/amniotic-based tissue product must meet the following 4 criteria: The HCT/P is:
Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39118)
Minimally ManipulatedIntended for Homologous Use (as reflected by the labeling, advertising, or other indications of the manufacturers objective intent)The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/PEither:The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; orThe HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:Is for autologous use;Is for allogeneic use in a first-degree or second-degree blood relative; orIs for reproductive use12
Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39118)
Due to the ongoing development of new products and clinical trials, the field of FDA regulatory requirements is fluid and evolving. It is the expectation that the respective Medicare Administrative Contractor will continue to follow any guidance and insight as it is brought forward by the FDA.Lack of standard formulation, dose, frequency of administration, and standard of care in treatment with these products further complicates regulation and guidance determinations.Despite this lack of standardization, numerous amniotic and placental-derived products have been released for use in treatment of musculoskeletal conditions. These conditions include, but are not limited to tendon/ligament injuries, musculoskeletal injuries, cartilage damage, osteoarthritis, (or pain related of these conditions) as well as an adjunctive to orthopedic surgical treatments. Due to the lack of component standardization, the remainder of this LCD will use the term amniotic and placental-derived products to mean ANY product derived from ANY combination of amniotic membrane/chorion/placenta/Whartons jelly/umbilical cord/amniotic fluid/umbilical cord blood.Although amniotic and placental-derived products are marketed to treat certain musculoskeletal conditions, there is limited support for safety and efficacy from human clinical trials available.
Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39118)
Although amniotic and placental-derived products are marketed to treat certain musculoskeletal conditions, there is limited support for safety and efficacy from human clinical trials available.All injectable amniotic and/or placental-derived products fall under FDA section 551 of the Federal Food, Drug, and Cosmetic Act. Promotion relating to novel indication or evidence of new intended use may constitute labeling, adulteration, or misbranding of the drug or device if such dissemination fails to comply with section 551 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aaa) and the requirements of this part. A manufacturers failure to exercise due diligence in submitting the clinical studies necessary for the approval of a new use as subject of information disseminated under this part or in beginning or completing such clinical studies shall be deemed a failure to comply with section 551 of the act and the requirement of this part. Use of any amniotic and/or placental-derived products that have not met the requirements of section 551 of the Federal Food, Drug, and Cosmetic Act will be denied per Medicare Benefit Policy Manual 100-2 Chapter 15 Section 50.4.1 and associated services will also be denied per Medicare Benefit Policy Manual 100-2 Chapter 16 Section 180.
Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39118)
General InformationAssociated InformationN/ASources of InformationN/ABibliographyZakrzewski W, Dobrzynski M, Szymonowicz M, and Rybak Z. Stem Cells: Past, Present, and Future. Stem Cell Research & Therapy 2019 10:68.doi:10.1186/s13287-019-1165-5Dhillon MS, Behera P, Patel S, and Shetty V. Orthobiologics and Platelet Rich Plasma. Indian J of Orthop. 2014 Jan-Feb; 48(1):1-9.doi:10.4103/0019-5413.125477Sultan AA, Piuzzi NS, Mont MA. Nonoperative Applications of Placental Tissue Matrix in Orthopaedic Sports Injuries: A Review of Literature. Clin J Sport Med. Jul 2020;30(4):383-389. doi:10.1097/jsm.0000000000000684Gabbe SG, Niebyl JR, Simpson JL, et al. Obstetricsnormal and problem pregnancies. 5th ed. Philadelphia: Churchill Livingstone; 2007.Niknejad H, Peirovi H, Jorjani M, Ahmadiani A, Ghanavi J, Seifalian AM. Properties of the Amniotic Membrane for Potential use in Tissue Engineering. European Cells and Materials. Vol. 15 2008. Pg 88-99.doi:10.22203/ecm.v015a07Huddleston HP, Cohn MR, Haunschild ED, Wong SE, Farr J, Yanke AB. Amniotic Product Treatments: Clinical and Basic Science Evidence. Curr Rev Musculoskelet Med. 2020 Apr;13(2):148-154. PMID: 32076938McIntyre JA, Jones IA, Danilkovich A, Vangsness CT Jr.McIntyre JA, et al. The Placenta: Applications in Orthopaedic Sports Medicine. Am J Sports Med. 2018 Jan;46(1):234-247.
Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39118)
Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. Am J Sports Med. 2016 Sep;44(9):2425-34.Hannon CP, Yanke AB, Farr J. Amniotic Tissue Modulation of Knee Pain-A Focus on Osteoarthritis. J Knee Surg. 2019 Jan;32(1):26-36. doi:10.1055/s-0038-1676370Leal-Marin S, Kern T, Hofmann N, Pogozhykh O, Framme C, Brgel M, Figueiredo C, Glasmacher B, Gryshkov O. Human Amniotic Membrane: A review on tissue engineering, application, and storage. J Biomed Mater Res. 2021;118. doi.org/10.1002/jbm.b.34782Farr J, Gomoll AH, Yanke AB, Strauss EJ, Mowry KC. A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. J Knee Surg. Nov 2019;32(11):1143-1154. doi:10.1055/s-0039-1696672FDA Guidance for Industry and Food and Drug Administration Staff. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. 2020 July.Guidance for Industry Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research. 2007 Aug.Gellhorn A.C., Han A. The use of dehydrated human amnion/chorion membrane allograft injection for the treatment of tendinopathy or arthritis: a case series involving 40 patients.PM&R. 2017;9(12):1236-1243. doi:10.1016/j.pmrj.2017.04.011
Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39118)
Buck D. Amniotic umbilical cord particulate for discogenic pain.Am. Osteopath. Assoc.2019;119(12):814-819. doi:10.7556/jaoa.2019.138Ross A, Gambrill V, Main C. Clinical outcomes of amniotic membrane/umbilical cord particulate in spinal disorders: a retrospective study.J Pain Res. 2022;15:3971-3979. doi:10.2147/JPR.S375201, 10.2147/JPR.S375201Ackley JF, Kolosky M, Gurin D, Hampton R, Masin R, Krahe D. Cryopreserved amniotic membrane and umbilical cord particulate matrix for partial rotator cuff tears: A case series. Medicine (Baltimore). Jul 2019;98(30):e16569. doi:10.1097/md.0000000000016569Aufiero, D, Sampson, S, Onishi, K, and Bemden, V. Treatment of medial and lateral elbow tendinosis with an injectable amniotic membrane allografta retrospective case series.J Pain Relief. 2016;5(3):242.Quinet MT, Raghavan M, Morris E, et al. Effectiveness of amniotic fluid injection in the treatment of trigger finger: a pilot study.Journal of Hand Surgery Global Online. 2020;2(5):301-305.Cazzell S., Stewart J., Agnew P.S., et al Randomized controlled trial of micronized dehydrated human amnion/chorion membrane (dHACM) injection compared to placebo for the treatment of plantar fasciitis.Foot Ankle Int. 2018;39(10):1151-1161. doi:10.1177/1071100718788549
Proposed LCD - Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound (DL39118)
Zelen C.M., Poka A., Andrews J. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis - A feasibility study.Foot Ankle Int. 2013;34(10):1332-1339. doi:10.1177/1071100713502179Hanselman 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 (DL39118)
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 (DL39118)
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 (DL39118)
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 fromguidelinedevelopment.org/handbook.
Proposed LCD - Colon Capsule Endoscopy (CCE) (DL38571)
CMS National Coverage PolicyTitle 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 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Code of Federal Regulations:42 CFR 410.32 indicates that diagnostic tests may only be ordered by a treating physician (or other treating practitioner acting within the scope of their license and Medicare requirements) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician (or other qualified non-physician provider) who is treating the beneficiary are not reasonable and necessary (see Sec. 411.15(k)(1) of this chapterCMS Publications:CMS Publication 100-04,Medicare Claims Processing Manual, Chapter 23: 10.1 - 10.1.7 ICD-10-CM Coding for Diagnostic Tests.Coverage Indications, Limitations, and/or Medical NecessityDiagnostic and/or surveillance* (performed for signs/symptoms of disease) colon capsule colonoscopy (CCE) is medically necessary for the detection of colon polyps when EITHER of the following criteria are met:Secondary procedure after an incomplete diagnostic optical colonoscopy (OC) with adequate preparation, and a complete evaluation of the colon was not technically possible (1,2) whenEITHERof the following criteria are metDetection or surveillance of colon polyp(s)ORDiagnostic procedure whenANYof the following criteria are met (3):Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical)ORMultitarget Stool DNA (sDNA) Test positiveORBlood-based biomarker colorectal cancer screening test positiveOROther evidence of lower GI bleed in hemodynamically stable patientsPrimary procedure in patients with major risks for OC or moderate sedation as indicated from an evaluation of the patient by a board certified or board eligible gastroenterologist, a surgeon trained in endoscopy, or a physician with equivalent endoscopic training whenEITHERof the following criteria are met:
Proposed LCD - Colon Capsule Endoscopy (CCE) (DL38571)
Surveillance of colon polyp(s) in previously diagnosed patientsORDiagnostic procedure whenANYof the following criteria are met (3):Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical)ORMultitarget Stool DNA (sDNA) Test positiveORBlood-based biomarker colorectal cancer screening test positiveOROther evidence of lower GI bleed in hemodynamically stable patientsExclusion Criteria (NONE of the below are allowed)Known or suspected gastrointestinal obstruction, stricture, or fistulaCardiac pacemaker or another implanted electro-medical device if the CCE device is contraindicated due to emission of a radiofrequency or other interfering signalSwallowing disorderKnown contraindication or allergy to any medication or preparation agent used before or during the procedureMay not be done in conjunction with CT Colonography (CTC)CCE is not a Medicare Benefit for colorectal cancer screening, regardless of family history or other risk factors for the development of colonic disease* Cancer Diagnostic strategies refer to the measures taken to investigate persons with symptoms suspicious for malignancy or as a result of positive screening tests. Cancer Surveillance refers to the interval utilization of diagnostic strategies in people with previously detected cancerous or pre-cancerous lesions. Cancer Screening strategies refer to those measures taken to diagnose cancerous and pre-cancerous lesions in asymptomatic people with no previous history of such.General InformationAssociated InformationN/ASources of InformationN/ABibliography
Proposed LCD - Colon Capsule Endoscopy (CCE) (DL38571)
FDA approves PillCam COLON as follow-up test.Cancer Discov.2014;4(4):380-381.PillCam COLON 2 Capsule Endoscopy System (K153466). https://www.accessdata.fda.gov/cdrh_docs/pdf15/K153466.pdf. Accessed 2/28/20.National Coverage Determination (NCD) for Colorectal Cancer Screening Tests (210.3).National Coverage Decision. Accessed 6/01/21.Rex DK, Adler SN, Aisenberg J, et al. Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population.Gastroenterology.2015;148(5):948-957 e942.Rondonotti E, Borghi C, Mandelli G, et al. Accuracy of capsule colonoscopy and computed tomographic colonography in individuals with positive results from the fecal occult blood test.Clin Gastroenterol Hepatol.2014;12(8):1303-1310.Spada C, Hassan C, Barbaro B, et al. Colon capsule versus CT colonography in patients with incomplete colonoscopy: a prospective, comparative trial.Gut. 2015;64(2):272-281.Holleran G, Leen R, OMorain C, McNamara DJE. Colon capsule endoscopy as possible filter test for colonoscopy selection in a screening population with positive fecal immunology.Endoscopy.2014;46(06):473-478.Kobaek-Larsen M, Kroijer R, Dyrvig AK, et al. Back-to-back colon capsule endoscopy and optical colonoscopy in colorectal cancer screening individuals.Colorectal Dis.2018;20(6):479-485.Morikawa T, Kato J, Yamaji Y, et al. Sensitivity of immunochemical fecal occult blood test to small colorectal adenomas.Am J Gastroenterol.2007;102(10):2259.
Proposed LCD - Colon Capsule Endoscopy (CCE) (DL38571)
Morgan DR, Malik PR, Romeo DP, Rex DK. Initial US evaluation of second-generation capsule colonoscopy for detecting colon polyps.BMJ Open Gastroenterol.2016;3(1):e000089.Spada C, Hassan C, Munoz-Navas M, et al. Second-generation colon capsule endoscopy compared with colonoscopy.Gastrointest Endosc.2011;74(3):581-589 e581.Eliakim R, Yassin K, Niv Y, et al. Prospective multicenter performance evaluation of the second-generation colon capsule compared with colonoscopy.Endoscopy.2009;41(12):1026-1031.Parodi A, Vanbiervliet G, Hassan C, et al. Colon capsule endoscopy to screen for colorectal neoplasia in those with family histories of colorectal cancer.Gastrointest Endosc.2018;87(3):695-704.Voska M, Zavoral M, Grega T, et al. Accuracy of Colon Capsule Endoscopy for Colorectal Neoplasia Detection in Individuals Referred for a Screening Colonoscopy.Gastroenterol Res Pract.2019;2019:5975438.Ohmiya N, Hotta N, Mitsufuji S, et al. Multicenter feasibility study of bowel preparation with castor oil for colon capsule endoscopy.Dig Endosc.2019;31(2):164-172.Blanes-Vidal V, Nadimi ES, Buijs MM, Baatrup GJIjocd. Capsule endoscopy vs. colonoscopy vs. histopathology in colorectal cancer screening: matched analyses of polyp size, morphology, and location estimates.Int J Colorectal Dis. 2018;33(9):1309-1312.Health Quality O. Colon Capsule Endoscopy for the Detection of Colorectal Polyps: An Evidence-Based Analysis.Ont Health Technol Assess Ser.2015;15(14):1-39.
Proposed LCD - Colon Capsule Endoscopy (CCE) (DL38571)
Health Quality O. Colon Capsule Endoscopy for the Detection of Colorectal Polyps: An Evidence-Based Analysis.Ont Health Technol Assess Ser.2015;15(14):1-39.Spada C, Pasha SF, Gross SA, et al. Accuracy of First- and Second-Generation Colon Capsules in Endoscopic Detection of Colorectal Polyps: A Systematic Review and Meta-analysis.Clin Gastroenterol Hepatol.2016;14(11):1533-1543 e1538.Enns RA, Hookey L, Armstrong D, et al. Canadian Clinical Practice Guidelines for the Use of Video Capsule Endoscopy.Gastroenterology.2017;152(3):497-514.Institute E. PillCam Colon 2 Capsule Endoscopy System (Medtronic plc) for Detecting Colon Polyps. .Hayes- Colon Capsule Endoscopy for Colorectal Cancer Screening, Diagnosis and Surveillance. 2019.Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: Recommendations for physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer.Gastrointest Endosc.2017;86(1):18-33.Hussey M, Holleran G, Stack R, Moran N, Tersaruolo C, McNamara D. Same-day colon capsule endoscopy is a viable means to assess unexplored colonic segments after incomplete colonoscopy in selected patients.United European Gastroenterol J.2018;6(10):1556-1562.