evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Allergen Immunotherapy (DL36240)
Coverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationAllergen Immunotherapy is defined as the repeated administration of specific allergens to individuals with IgE-mediated conditions to provide protection against allergic symptoms and inflammatory reactions associated with natural exposure to these allergens.1Allergen immunotherapy should be considered for patients who have discernable evidence of specific IgE antibodies to clinically relevant allergens. The decision to begin allergen immunotherapy may depend on a number of factors, including but not limited to, patient's preference/acceptability, adherence, medication requirements, response to avoidance methods, and the adverse effects of medications. The severity and duration of symptoms should also be considered when evaluating the need for allergen immunotherapy.1The presence of IgE antibodies alone does not infer the need for immunotherapy; the presence of IgE antibodies to an allergen must correlate with the patients history.1For example, the presence of IgE antibodies to an allergen not locally found, with no history of exposure or expectation of exposure, would not be considered clinically relevant.In order for allergen immunotherapy to be considered medically reasonable and necessarybothof the following criteria must be met:The allergen(s) to which the patient is allergic must be clinically relevant, andTrial of avoidance measures has failed or there is unavoidable exposure to allergy triggers identified in allergy testing.1Covered IndicationsConditions for which immunotherapy will be considered medically reasonable and necessary include:Allergic rhinitisAllergic conjunctivitisAllergic asthma2-9Dust mite atopic dermatitis1,9-11Stinging insect hypersensitivity (e.g., bees, hornets, wasps, fire ants)1-9Although all treatment regimens must be individualized for a given patient, immunotherapy generally has two phases. Abuild-up phaseand amaintenance phase.
Proposed LCD - Allergen Immunotherapy (DL36240)
Although all treatment regimens must be individualized for a given patient, immunotherapy generally has two phases. Abuild-up phaseand amaintenance phase.Thebuild-up phaseincludes the initiation and subsequent increase of applicable antigen concentrations within 8-28 weeks. Usually a single dose increase is administered per visit and visits generally vary from 1-3 times per week. Accelerated timetables, also referred to as rush or cluster immunotherapy, involve giving several injections at increasing doses on a single visit.1,9Themaintenance phaseoccurs when the effective therapeutic dose is reached. This dose provides therapeutic effectiveness without significant adverse local or systemic consequences. This dose may not be the initial targeted concentration/dose. The maintenance immunotherapy schedule is generally every 4-8 weeks for venoms and every 2-4 weeks for inhalant allergens. Maintenance immunotherapy generally involves follow-up visits every 6-12 months.1,2,9Length of Maintenance Therapy:The duration of all forms of immunotherapy must be individualized. A presumption of failure can be made when, after 12-24 months of therapy, a person does not experience:A noticeable decrease of symptoms,An increase in tolerance to the offending allergen, andA reduction in medication usage.For many patients, the recommended duration of allergen immunotherapy is 3-5 years. However, the duration of immunotherapy should be individualized based on the benefits sustained from therapy, disease severity, immunotherapy reaction, patient preference and certain antigens in the therapy.1,2,9Desensitizationis the rapid administration of incremental doses of allergens or medications by which effector cells are rendered less reactive or nonreactive to an IgE-mediated immune response. Tolerance to medications can be achieved through desensitization.1Limitations
Proposed LCD - Allergen Immunotherapy (DL36240)
LimitationsPatients should not have substantial comorbid conditions that could increase immunotherapy risk (e.g., severe asthma uncontrolled by pharmacotherapy, significant cardiovascular disease).Patients on beta-blockers and/or angiotensin-converting enzyme (ACE) inhibitor medications must have individualized assessments of risk versus benefit prior to receiving inhalant or venom allergen immunotherapy.Patients should be able to cooperate during therapy.Please refer to the CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 15, Section 50.4.4.1 Antigens for additional limitations.Please refer to the CMS IOM Publication 100-03,Medicare National Coverage Determinations (NCD)Manual, Chapter 1, Part 2 Sections 110.9 Antigens Prepared for Sublingual Administration and 110.11 Food Allergy Testing and Treatment for additional limitations.Allergen immunotherapy is not considered medically reasonable and necessary for:Food hypersensitivity1,12-14Cockroach hypersensitivity1Urticaria and/or angioedema1,12,13Provocation-neutralization therapy1,13Low-dose subcutaneous therapy based on the Rinkel method6,12,13Therapy formulations, such as allergoids or adjuvants1The following routes of administration6,12,13:Oral or sublingual for food immunotherapyEpicutaneous immunotherapyIntralymphatic immunotherapyIntranasal immunotherapySublingual ImmunotherapyImmunotherapy for Hymenoptera venom sensitivity using whole-body extracts, with the exception of fire ant extracts.1,2,9Place of Services (POS)Immunotherapy may have severe unpredictable systemic and local reactions within the first 30 minutes following the injection. It is recommended that immunotherapy be administered in a setting that permits the prompt recognition and management of adverse reactions, particularly anaphylaxis. It is recommended that patients wait at the physician's office/medical clinic for at least 30 minutes after the immunotherapy injection.1,6,9
Proposed LCD - Allergen Immunotherapy (DL36240)
Home administration of allergen immunotherapy should only be considered in rare and exceptional cases when the benefits of immunotherapy clearly outweigh the risks. Frequent or routine home immunotherapy is not considered appropriate under any circumstances. If this method is utilized, informed consent should be attained from the patient and the individual administering the injection must be trained and equipped to recognize and manage immunotherapy reactions, particularly anaphylaxis.1Provider QualificationsServices will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the providers professional licensure, when performed according to the supervision requirements per state scope of practice laws, and when all procedures are performed by appropriately trained providers in the appropriate setting.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationPlease refer to the related Local Coverage Article: Billing and Coding: Allergen Immunotherapy, A56538, for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationN/ABibliographyThis bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.
Proposed LCD - Allergen Immunotherapy (DL36240)
Cox L, Nelson H, Lockey R, Calabria C, et al. Allergen immunotherapy: a practice parameter third update.J Allergy Clin Immunol. January 2011;127(1 Suppl):S1-55. doi:10.1016/j.jaci.2010.09.034.Golden DB, Demain J, Freeman T, et al. Stinging insect hypersensitivity: A practice parameter update 2016.Ann Allergy Asthma Immunol. 2017;118(1):28-54. doi:10.1016/j.anai.2016.10.031.Lin SY, Azar A, Suarez-Cuervo C, et al. The Role of Immunotherapy in the Treatment of Asthma. Comparative Effectiveness Review No. 196 (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No.290-2015-00006-I). AHRQ Publication No. 17(18)-EHC029-EF. Rockville, MD: Agency for Healthcare Research and Quality. March 2018. doi:10.23970/AHRQEPCCER196.Lin SY, Erekosima N, Suarez-Cuervo C, et al. Allergen-Specific Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and/or Asthma: Comparative Effectiveness Review. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Mar. Report No.: 13-EHC061-EF. https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/asthma-immunotherapy-2010_research-protocol.pdf. Accessed August 11, 2020.Brozek JL, Bousquet J, Baena-Cagnani CE, et al. Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision.J Allergy Clin Immunol. 2010;126(3):466-76. doi:10.1016/j.jaci.2010.06.047.
Proposed LCD - Allergen Immunotherapy (DL36240)
Burks AW, Calderon MA, Casale T, et al. Update on allergy immunotherapy: American Academy of Allergy, Asthma & Immunology/European Academy of Allergy and Clinical Immunology/PRACTALL consensus report.J Allergy Clin Immunol. May 2013;131(5):1288-1296. doi:10.1016/j.jaci.2013.01.049.Caldern MA, Alves B, Jacobson M, Hurwitz B, Sheikh A, Durham S. Allergen injection immunotherapy for seasonal allergic rhinitis.Cochrane Database of Syst Rev.January 2007;(1). Art. No.CD001936. doi:10.1002/14651858.CD001936.pub2.Caldern MA, Casale TB, Togias A, Bousquet J, Durham SR, Demoly P. Allergen-specific immunotherapy for respiratory allergies: from meta-analysis to registration and beyond.J Allergy Clin Immunol. 2011;127(1):30-38. doi:10.1016/j.jaci.2010.08.024.Moote W, Kim H, Ellis AK. Allergen-specific immunotherapy.Allergy Asthma Clin Immunol. 2018;14(Suppl 2):53. doi:10.1186/s13223-018-0282-5.Bae JM, Choi YY, Park CO, Chung KY, Lee KH. Efficacy of allergen-specific immunotherapy for atopic dermatitis: a systematic review and meta-analysis of randomized controlled trials.J Allergy Clin Immunol. 2013;132(1):110-117. doi:10.1016/j.jaci.2013.02.044.Lee J, Park CO, Lee KH. Specific immunotherapy in atopic dermatitis.Allergy Asthma Immunol Res. 2015;7(3):221-229. doi:10.4168/aair.2015.7.3.221.
Proposed LCD - Allergen Immunotherapy (DL36240)
Bernstein JA, Lang DM, Khan DA, et al. The diagnosis and management of acute and chronic urticaria: 2014 update.J Allergy Clin Immunol. 2014;133(5):1270-1277. doi:10.1016/j.jaci.2014.02.036.Sampson HA, Aceves S, Bock SA, et al. Joint Task Force on Practice Parameters, Food allergy: a practice parameter update-2014.J Allergy Clin Immunol. 2014;134(5):1016-1025. doi:10.1016/j.jaci.2014.05.013.Boyce JA, Assa'ad A, Burks AW, et al. Guidelines for the diagnosis and management of food allergy in the United States: summary of the NIAID-sponsored expert panel report.J Am Acad Dermatol. 2011;64(1):175-192. doi:10.1016/j.jaad.2010.11.020.Mortuaire G, Michel J, Papon JF, et al. Specific immunotherapy in allergic rhinitis.Eur Ann Otorhinolaryngol Head Neck Dis. 2017;134(4):253-258. doi:10.1016/j.anorl.2017.06.005.Nelson HS. To mix or not to mix in allergy immunotherapy vaccines.Curr Opin Allergy Clin Immunol. 2021;21(6):583-589. doi:10.1097/ACI.0000000000000784.Nelson HS. Multiallergen immunotherapy for allergic rhinitis and asthma.J Allergy Clin Immunol. 2009;123(4):763-769. doi:10.1016/j.jaci.2008.12.013.Wise SK, Lin SY, Toskala E, et al. International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis.Int Forum Allergy Rhinol. 2018;8(2):108-352. doi:10.1002/alr.22073.
Proposed LCD - Allergen Immunotherapy (DL36240)
Wood RA, Togias A, Wildfire J, et al. Development of cockroach immunotherapy by the Inner-City Asthma Consortium.J Allergy Clin Immunol. 2014;133(3):846-52.e6. doi:10.1016/j.jaci.2013.08.047.Seidman MD, Gurgel RK, Lin SY, et al. Clinical practice guideline: Allergic rhinitis.Otolaryngol Head Neck Surg. 2015;152(1 Suppl):S1-S43. doi:10.1177/0194599814561600.
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38657)
CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Implantable Continuous Glucose Monitors (CGM). Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Implantable Continuous Glucose Monitors (CGM) and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM 100-08,Medicare Program Integrity Manual,Chapter 13, Section 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.Coverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationCovered IndicationsI-CGMs are class III medical devices that require premarket approval by the FDA. In order to be considered reasonable and necessary, the FDA approved indication must include use as a therapeutic CGM.1The FDA recently approved expanding the indications of an implantable CGM product to replace fingerstick blood glucose measurements for diabetes treatment decisions.Therapeutic I-CGMs are considered reasonable and necessary by Medicare when all of the following coverage criteria (1-4) are met:
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38657)
The beneficiary has diabetes mellitus (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses); and,The beneficiary's treating practitioner has concluded that the beneficiary (or beneficiary's caregiver) has sufficient training using the I-CGM prescribed as evidenced by providing a prescription; and,The I-CGM is prescribed in accordance with its FDA indication for use; and,The beneficiary for whom a I-CGM is being prescribed, to improve glycemic control, meets at least one of the criteria below:The beneficiary is insulin-treated; or,The beneficiary has a history of problematic hypoglycemia with documentation of at least one of the following:Recurrent (more than one) level 2 hypoglycemic events (glucose <54mg/dl (3.0mmol/L)) that persists despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan; or,A history of one level 3 hypoglycemic event (glucose <54mg/dl (3.0mmol/L)) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia.CMG Continued CoverageEvery six (6) months following the initial prescription of the CGM, the treating practitioner conducts an in-person or Medicare approved telehealth visit with the beneficiary to document adherence to their CGM regimen and diabetes treatment plan.LimitationsI-CGM devices will not be considered reasonable and necessary for short-term (72 hours to 1 week) diagnostic use.ExceptionFor those beneficiaries who have previously met the coverage criteria for a non-implantable therapeutic continuous glucose monitor through the Medicare DME benefit and subsequently choose to switch to the implantable device, they may do so with a provider order. However, all other coverage criteria above must be fulfilled in order for Medicare payment.General InformationAssociated InformationPlease refer to the related Billing and Coding Article: Implantable Continuous Glucose Monitors (I-CGM) (A58133) for documentation and utilization requirements as applicable.Sources of InformationN/ABibliography
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38657)
Department of Health and Human Services. Centers for Medicare & Medicaid Services. CMS Rulings. CMS-1682-R. Accessed August 16, 2023,https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/CMS-Rulings-Items/CMS1682RSapra A, Bhandari P. Diabetes. StatPearls Publishing. Accessed August 9, 2023,https://www.ncbi.nlm.nih.gov/books/NBK551501/Centers for Disease Control and Prevention (CDC). What is Diabetes? Accessed August 10, 2023,https://www.cdc.gov/diabetes/basics/diabetes.htmlCenters for Disease Control and Prevention (CDC). Prevalence of Both Diagnosed and Undiagnosed Diabetes. Accessed August 10, 2023,https://www.cdc.gov/diabetes/data/statistics-report/diagnosed-undiagnosed-diabetes.htmlAmerican Diabetes Association (ADA). Economic Costs of Diabetes in the U.S. in 2017.Diabetes Care. May 2018;41(5):917-928. doi:10.2337/dci18-0007American Diabetes Association (ADA). Standards of Care in Diabetes-2023 Abridged for Primary Care Providers.Clin Diabetes. Winter 2022;41(1):4-31. doi:10.2337/cd23-as01Solano L. Seven facts you need to know about continuous glucose monitors.Jaapa. Sep 1 2022;35(9):41-45. doi:10.1097/01.JAA.0000854536.09072.5eAdolfsson P, Parkin CG, Thomas A, Krinelke LG. Selecting the Appropriate Continuous Glucose Monitoring System - a Practical Approach.Eur Endocrinol. Apr 2018;14(1):24-29. doi:10.17925/ee.2018.14.1.24Cowart K. A Review of the First Long-term Implantable Continuous Glucose Monitoring System Available in the United States.J Diabetes Sci Technol. Jan 2021;15(1):160-166. doi:10.1177/1932296819890865
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38657)
Heinemann L, Schoemaker M, Schmelzeisen-Redecker G, et al. Benefits and Limitations of MARD as a Performance Parameter for Continuous Glucose Monitoring in the Interstitial Space.J Diabetes Sci Technol. Jan 2020;14(1):135-150. doi:10.1177/1932296819855670Freckmann G. Basics and use of continuous glucose monitoring (CGM) in diabetes therapy. 2020;44(2):71-79. Journal of Laboratory Medicine. doi:doi:10.1515/labmed-2019-0189Barnard KD, Kropff J, Choudhary P, et al. Acceptability of Implantable Continuous Glucose Monitoring Sensor.J Diabetes Sci Technol. May 2018;12(3):634-638. doi:10.1177/1932296817735123Boscari F, Vettoretti M, Amato AML, et al. Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor.Nutr Metab Cardiovasc Dis. Feb 8 2021;31(2):650-657. doi:10.1016/j.numecd.2020.09.006Boscari F, Vettoretti M, Cavallin F, et al. Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance.J Endocrinol Invest. Jan 2022;45(1):115-124. doi:10.1007/s40618-021-01624-2Christiansen MP, Klaff LJ, Bailey TS, Brazg R, Carlson G, Tweden KS. A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: The PRECISION Study.Diabetes Technol Ther. May 2019;21(5):231-237. doi:10.1089/dia.2019.0020
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38657)
Christiansen MP, Klaff LJ, Brazg R, et al. A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II.Diabetes Technol Ther. Mar 2018;20(3):197-206. doi:10.1089/dia.2017.0142Dehennis A, Mortellaro MA, Ioacara S. Multisite Study of an Implanted Continuous Glucose Sensor Over 90 Days in Patients With Diabetes Mellitus.J Diabetes Sci Technol. Jul 29 2015;9(5):951-6. doi:10.1177/1932296815596760Fokkert M, van Dijk PR, Edens MA, et al. Performance of the Eversense versus the Free Style Libre Flash glucose monitor during exercise and normal daily activities in subjects with type 1 diabetes mellitus.BMJ Open Diabetes Res Care. Aug 2020;8(1)doi:10.1136/bmjdrc-2020-001193Garg SK, Liljenquist D, Bode B, et al. Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study.Diabetes Technol Ther. Feb 2022;24(2):84-92. doi:10.1089/dia.2021.0182Jafri RZ, Balliro CA, El-Khatib F, et al. A Three-Way Accuracy Comparison of the Dexcom G5, Abbott Freestyle Libre Pro, and Senseonics Eversense Continuous Glucose Monitoring Devices in a Home-Use Study of Subjects with Type 1 Diabetes.Diabetes Technol Ther. Nov 2020;22(11):846-852. doi:10.1089/dia.2019.0449Kropff J, Choudhary P, Neupane S, et al. Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial.Diabetes Care. Jan 2017;40(1):63-68. doi:10.2337/dc16-1525
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38657)
Mortellaro M, DeHennis A. Performance characterization of an abiotic and fluorescent-based continuous glucose monitoring system in patients with type 1 diabetes.Biosens Bioelectron. Nov 15 2014;61:227-31. doi:10.1016/j.bios.2014.05.022Sanchez P, Ghosh-Dastidar S, Tweden KS, Kaufman FR. Real-World Data from the First U.S. Commercial Users of an Implantable Continuous Glucose Sensor.Diabetes Technol Ther. Dec 2019;21(12):677-681. doi:10.1089/dia.2019.0234Tweden KS, Deiss D, Rastogi R, Addaguduru S, Kaufman FR. Longitudinal Analysis of Real-World Performance of an Implantable Continuous Glucose Sensor over Multiple Sensor Insertion and Removal Cycles.Diabetes Technol Ther. May 2020;22(5):422-427. doi:10.1089/dia.2019.0342Wang X, Ioacara S, DeHennis A. Long-Term Home Study on Nocturnal Hypoglycemic Alarms Using a New Fully Implantable Continuous Glucose Monitoring System in Type 1 Diabetes.Diabetes Technol Ther. Nov 2015;17(11):780-6. doi:10.1089/dia.2014.0375American Diabetes Association (ADA). Understanding A1C. A1c Does it All. Accessed August 16, 2023,https://diabetes.org/diabetes/a1cIrace C, Cutruzzol A, Nuzzi A, et al. Clinical use of a 180-day implantable glucose sensor improves glycated haemoglobin and time in range in patients with type 1 diabetes.Diabetes Obes Metab. Jul 2020;22(7):1056-1061. doi:10.1111/dom.13993Renard E, Riveline JP, Hanaire H, Guerci B. Reduction of clinically important low glucose excursions with a long-term implantable continuous glucose monitoring system in adults with type 1 diabetes prone to hypoglycaemia: the France Adoption Randomized Clinical Trial.Diabetes Obes Metab. May 2022;24(5):859-867. doi:10.1111/dom.14644