Contractor Information. LCD Information. FUTURE Local Coverage Determination (LCD): Allergen Immunotherapy (L36240) Document Information

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1 FUTURE Local Coverage Determination (LCD): Allergen Immunotherapy (L36240) Links in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website. Please note: Future Effective Date. Contractor Information Contractor Name Novitas Solutions, Inc. Back to Top Contract Number Contract Type A and B MAC Jurisdiction J - H LCD Information Document Information L36240 Original ICD-9 LCD ID LCD Title Allergen Immunotherapy LCD ID AMA CPT / ADA CDT / AHA NUBC Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association. Jurisdiction Texas Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 10/01/2015 Revision Ending Date Retirement Date Notice Period Start Date Notice Period End Date Printed on 9/21/2015. Page 1 of 10

2 UB-04 Manual. OFFICIAL UB-04 DATA SPECIFICATIONS MANUAL, 2014, is copyrighted by American Hospital Association ( AHA ), Chicago, Illinois. No portion of OFFICIAL UB-04 MANUAL may be reproduced, sorted in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior express, written consent of AHA. Health Forum reserves the right to change the copyright notice from time to time upon written notice to Company. CMS National Coverage Policy Title XVIII of the Social Security Act 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. Title XVIII of the Social Security Act Section 1862 (a)(1)(d) excludes payment for services that are investigational or experimental. Title XVIII of the Social Security Act Section 1862(a)(7). This section excludes routine physical examinations. Title XVIII of the Social Security Act Section 1833 (e) prohibits Medicare payment for any claim which lacks the necessary information to process a claim. Medicare Benefit Policy Manual - Pub , Chapter 15, Section Physician expense for Allergy Treatment. Medicare Benefit Policy Manual - Pub , Chapter 15, Section Payment for Antigens. Medicare National Coverage Determination Manual , Chapter 1, Section Antigens Prepared for Sublingual Administration. Medicare National Coverage Determination Manual Chapter 1, Section Food and Allergy Testing and Treatments. Medicare Claims Processing Manual Chapter 12, Section 200 Allergy Testing and Immunotherapy. Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier. Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits. Allergen Immunotherapy is defined as the repeated administration of specific allergens to patients with IgEmediated conditions for the purpose of providing protection against allergic symptoms and inflammatory reactions associated with natural exposure to these allergens. Allergen immunotherapy should be considered for patients who have demonstrable evidence of specific IgE antibodies to clinically relevant allergens. The decision to begin allergen immunotherapy might depend on a number of factors, including but not limited to patient's preference/acceptability, adherence, medication requirements, response to avoidance, and the adverse effects of medications. The presence of IgE antibodies alone does not infer the need for immunotherapy. For example the presence of IgE antibodies to an allergen not locally found, with no history or exposure or expectation of exposure, would not be considered to be clinically relevant. In order for immunotherapy to be considered reasonable and necessary there must be: Clinical relevance Trial of avoidance or unavoidable exposure to allergy triggers identified in allergy testing Adherence to medical regimens which is clearly documented in the medical record Printed on 9/21/2015. Page 2 of 10

3 Stable pharmacotherapy for certain conditions, such as asthma Medical documentation should demonstrate the decision to begin immunotherapy. Without clear cut reasoning documented, these services will be denied. In 2010, a Joint Task Force on Practice Parameters for Allergen Immunology issued guidelines. The Task Force included American Academy of Allergy, Asthma and Immunology (AAAAI), the American College of Allergy, Asthma and Immunology (ACAAI), and the Joint Council of Allergy, Asthma and Immunology. As these guidelines were peer reviewed, incorporated, and invited reviewers, they are felt to be the state of the art in allergen immunotherapy. The indications set out in this LCD often will reflect the principals set out in the Practice Parameters when Medicare guidelines allow. INDICATIONS: Conditions for which immunotherapy is effective include: Allergic rhinitis, Allergic conjunctivitis, Allergic asthma and Stinging insect hypersensitivity. Please note: Atopic dermatitis secondary to aeroallergen has been reported to be influenced by immunotherapy. (These rare issues will be reviewed through the appeals process with documentation review.) Immunotherapy has two phases. A build-up phase and a maintenance phase. The build-up phase includes the initiation and subsequent rise of applicable antigen concentrations. Documentation of this phase should include the initial concentration, any changes/delay of progress and the reasoning for such delays, and the target concentration. Injections usually occur 1-3 times per week and can take anywhere from 8-28 weeks to achieve a maintenance dose. Since it should be rare that injections would be administered less frequent than the dosing intervals above, providers should expect denials when reporting these services less frequently. These less frequent services will need to be reviewed through the appeals process with documentation as to why the frequency was not met, i.e. hospitalizations, illness, acute asthma events which would preclude the continuation of the build-up phase. Various techniques such as cluster immunotherapy and rush immunotherapy are also included in the build-up phase and should be documented as such in the medical records. These techniques are noted to have more frequent injections in the build-up phase. The maintenance phase occurs when the effective therapeutic dose is reached. This dose is defined as the dose that provides therapeutic efficacy without significant adverse local or systemic reactions. This dose may not be the initial target concentration but documentation should clearly show why the target concentration is not being used. All references to the therapeutic effective dose should be referenced to the maintenance concentrate and should be noted as a volume-to-volume dilution (e.g., 1:100 vol/vol dilution of maintenance concentrate). Although all treatment regimens have to be individualized for a given patient, acceptable maintenance dose concentrations are generally as the following: For standard allergen extracts: 500 to 2,000 allergy units (AU; e.g. for dust mite): or 1,000-4,000 bioequivalent allergy units (BAU; e.g. for grass or cat). For non-standardized extracts: a suggested maintenance dose is 3,000-5,000 protein nitrogen units (PNU) or 0.5ml of a 1:100 or 1:200 wt/vol dilution of manufacturer's extract; non-standard extracts are noted to be estimates and will need to be individualized. Printed on 9/21/2015. Page 3 of 10

4 For major known allergen concentration of the extract: a range between 5 and 20 micrograms of major allergen is the recommended maintenance dose for inhalant allergens and 100 micrograms for Hymenoptra venon. Documentation of the extracts being used should include concentrations, even if an estimate is used for nonstandard extracts. Significant sub-therapeutic dosing in a maintenance manner will be considered not reasonable and necessary. Table IX and X in the Guidelines outline probable effective dose ranges. Sub-therapeutic dosing would be considered to be below these levels. Providers of Immunotherapy: The physician prescribing immunotherapy should be trained and experienced in prescribing and administering immunotherapy. Should any Medicare entity (MAC, RA, ZPIC, OIG or DOJ) request documentation of training this information must be made available. Medicare expects practitioners documented training to be commensurate with the degree to which his or her practice is related to allergy testing and immunotherapy. Allergen Supply: The Medicare Benefit Manual Chapter 12, outlines the benefit for the supply of antigen use in immunotherapy. 'Payment may be made for a reasonable supply of antigens that have been prepared for a particular patient if: (1) the antigens are prepared by a physician who is a doctor of medicine or osteopathy, and (2) the physician who prepared the antigens has examined the patient and has determined a plan of treatment and a dosage regimen.' Hence, if an auxiliary staff member, such as a registered nurse or technician, prepares the antigens, the physician must provide direct supervision of the services for the employee to bill incident-to the physician based on Medicare incident-to-rules. The preparation of allergen extract should have direct supervision of any employee. Definition of qualified non-physician practitioner (NPP) must meet incident-to guidelines. For services to qualify as incident-to: The NPP must be licensed or certified to provide professional health care services in the state where the physician practice is located. Generally, the NPP must be a full-time, part-time or leased employee of the physician or physician group practice. (In limited cases, the NPP may be an independent contractor of the physician or physician group practice.) The NPP must provide services as an integral part of-and-incident-to the physician's services. The NPP must provide such services under the direct supervision of the physician. Direct supervision does not mean that the physician must be in the same room when the staff person prepares the antigens. The physician must be present in the office suite and immediately available to provide direction and assistance through the time the staff person is performing the service. The supervision physician should be documented. The physician must have examined the patient and determined a plan of treatment and a dosage regimen. Place of Administration: Immunotherapy may have severe unpredictable systemic and local reactions within the first 30 minutes post injection. It is recommended that immunotherapy be administered in a setting that permits the prompt recognition and management of adverse reaction. The preferred location for such administration is the prescribing physician's office. However, the patients can receive immunotherapy at another health care facility if the physician and staff at that location are trained and equipped to recognize and manage immunotherapy 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. Medicare payment for maintenance antigens administered by a trained individual in the patient s home is permitted by regulation. In such cases the patient s medical record must include information about the training and competence of the administering individual, especially training for emergency management of adverse reactions to immunotherapy injections (e.g. recognition of anaphylaxis and administration of rescue medications such as epinephrine). Such information must be made available to Medicare for review if requested. Printed on 9/21/2015. Page 4 of 10

5 Maintenance Dose Interval: The frequency of maintenance dosing can be variable depending on the extract used. During the first year, frequency may vary from subsequent years. The Task Force notes for some antigens, the maintenance dose could be every 4-8 weeks. However, the frequency should be at least every two weeks for this dosing. Follow-up Care: During maintenance therapy, follow up visits to assess progress or lack of progress should be done at least every 6-12 months. This documentation must be available upon request. Length of Maintenance Therapy: The duration of all forms of immunotherapy must be individualized. A presumption of failure can be made when, after months of therapy, a person does not experience: a noticeable decrease of symptoms, an increase in tolerance to the offending allergen, and a reduction in medication usage. Treatment will not be reimbursed after a 2 year period when there is no apparent clinical benefit as noted above. For many patients, the recommended duration of allergen immunotherapy is 3-5 years. However, the duration of immunotherapy should be individualized based on the clinical response, disease severity, immunotherapy reaction, patient preference and certain antigens in the therapy. Allergen immunotherapy is not indicated and is considered investigational for: Food hypersensitivity Urticaria and angioedema Therapy with allergoids or adjuvants Therapy Via Other administration: Oral or sublingual food immunotherapy Epicutaneous immunotherapy Intralymphatic immunotherapy Intranasal immunotherapy Sublingual Immunotherapy Desensitization with commercially available extracts of poison ivy, poison oak, or poison sumac, Desensitization for hymenoptera sensitivity using whole body extracts, with the exception of fire ant extracts Desensitization with bacterial vaccine (BAC: bacterial, antigen complex, streptococcus vaccine, staphylostreptovaccine, serobacterin, staphylococcus phage lysate) Food allergenic extract immunotherapy Intracutaneous desensitization (Rinkel Injection Therapy, RIT) Intracutaneous titration Neutralization therapy (intradermal and subcutaneous) Repository emulsion therapy Sublingual desensitization Sublingual provocative therapy Urine autoinjection (autogenous, urine immunotherapy) Allergen immunotherapy for the management of skin and mucous membrane disease such as atopic dermatitis (rare exceptions as noted above reviewed in the appeals process), urticarial, and Candida vulvovaginitis Intranasal immunotherapy Postmortem examination for IgE antibodies to identify allergens responsible for lethal anaphylaxis (post mortem work is not covered by Medicare) Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, 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. As published in CMS IOM , Chapter 13, Section , in order to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which Printed on 9/21/2015. Page 5 of 10

6 the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is: Safe and effective Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, that meet the requirements of the Clinical Trials NCD are considered reasonable and necessary). Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is: Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member. Furnished in a setting appropriate to the patient's medical needs and condition. Ordered and furnished by qualified personnel. One that meets, but does not exceed, the patient's medical needs. At least as beneficial as an existing and available medically appropriate alternative. Back to Top Coding Information Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. 012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient 018x Hospital - Swing Beds 021x Skilled Nursing - Inpatient (Including Medicare Part A) 022x Skilled Nursing - Inpatient (Medicare Part B only) 023x Skilled Nursing - Outpatient 071x Clinic - Rural Health 073x Clinic - Freestanding 075x Clinic - Comprehensive Outpatient Rehabilitation Facility (CORF) 077x Clinic - Federally Qualified Health Center (FQHC) 085x Critical Access Hospital Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes. Note: The contractor has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub , Claims Processing Manual, for further guidance Clinic - General Classification 0517 Clinic - Family Practice Clinic Printed on 9/21/2015. Page 6 of 10

7 0519 Clinic - Other Clinic 0520 Freestanding Clinic - General Classification 0521 Freestanding Clinic - Clinic Visit by Member to RHC/FQHC 0522 Freestanding Clinic - Home Visit by RHC/FQHC Practitioner 0523 Freestanding Clinic - Family Practice Clinic Freestanding Clinic - Visit by RHC/FQHC Practitioner to a Member in a SNF or Skilled Swing Bed in a 0524 Covered Part A Stay Freestanding Clinic - Visit by RHC/FQHC Practitioner to a Member in a SNF (not in a Covered Part A Stay) 0525 or NF or ICF MR or Other Residential Facility 0528 Freestanding Clinic - Visit by RHC/FQHC Practitioner to Other non-rhc/fqhc site (e.g. Scene of Accident) 0529 Freestanding Clinic - Other Freestanding Clinic 0982 Professional Fees - Outpatient Services 0983 Professional Fees - Clinic CPT/HCPCS Codes Group 1 Paragraph: Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. Group 1 Codes: Immunotherapy one injection Immunotherapy injections Antigen therapy services Antigen therapy services Antigen therapy services Antigen therapy services Antigen therapy services Antigen therapy services Antigen therapy services Antigen therapy services Rapid desensitization Allergy immunology services ICD-10 Codes that Support Medical Necessity Group 1 Paragraph: Note: Providers should continue to submit ICD-10-CM diagnosis codes without decimals on their claim forms and electronic claims. It is the provider s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claims(s) submitted. The CPT/HCPCS codes included in this LCD will be subjected to "procedure to diagnosis" editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary. Medicare is establishing the following limited coverage for all CPT/HCPCS codes listed above with the exception of and 95180: Group 1 Codes: ICD-10 Codes Description H Chronic giant papillary conjunctivitis, right eye H Chronic giant papillary conjunctivitis, left eye H Chronic giant papillary conjunctivitis, bilateral H10.45 Other chronic allergic conjunctivitis J30.0 Vasomotor rhinitis J30.1 Allergic rhinitis due to pollen J30.2 Other seasonal allergic rhinitis J30.81 Allergic rhinitis due to animal (cat) (dog) hair and dander Printed on 9/21/2015. Page 7 of 10

8 ICD-10 Codes Description J30.89 Other allergic rhinitis J45.20 Mild intermittent asthma, uncomplicated J45.30 Mild persistent asthma, uncomplicated J Unspecified asthma, uncomplicated J82 Pulmonary eosinophilia, not elsewhere classified T63.91XA Toxic effect of contact with unspecified venomous animal, accidental (unintentional), initial encounter T63.92XA Toxic effect of contact with unspecified venomous animal, intentional self-harm, initial encounter T63.93XA Toxic effect of contact with unspecified venomous animal, assault, initial encounter T63.94XA Toxic effect of contact with unspecified venomous animal, undetermined, initial encounter T78.2XXA Anaphylactic shock, unspecified, initial encounter T78.40XA Allergy, unspecified, initial encounter T78.49XA Other allergy, initial encounter Z Bee allergy status Z Other insect allergy status Z Other nonmedicinal substance allergy status Z91.09 Other allergy status, other than to drugs and biological substances Group 2 Paragraph: Medicare is establishing the following limited coverage for CPT/HCPCS code 95170: Group 2 Codes: ICD-10 Codes Description T63.481A* Toxic effect of venom of other arthropod, accidental (unintentional), initial encounter T78.2XXA Anaphylactic shock, unspecified, initial encounter Group 2 Medical Necessity ICD-10 Codes Asterisk Explanation: **T63.481A should be used as an additional code for more detailed analysis. Group 3 Paragraph: Medicare is establishing the following limited coverage for CPT/HCPCS code 95180: Group 3 Codes: ICD-10 Codes Description T36.0X5A Adverse effect of penicillins, initial encounter T36.1X5A Adverse effect of cephalosporins and other beta-lactam antibiotics, initial encounter T36.4X5A Adverse effect of tetracyclines, initial encounter T36.8X5A Adverse effect of other systemic antibiotics, initial encounter T36.95XA Adverse effect of unspecified systemic antibiotic, initial encounter T37.0X5A Adverse effect of sulfonamides, initial encounter T37.1X5A Adverse effect of antimycobacterial drugs, initial encounter T39.015A Adverse effect of aspirin, initial encounter T39.095A Adverse effect of salicylates, initial encounter T48.6X5A Adverse effect of antiasthmatics, initial encounter T48.995A Adverse effect of other agents primarily acting on the respiratory system, initial encounter T50.8X5A Adverse effect of diagnostic agents, initial encounter T50.Z95A Adverse effect of other vaccines and biological substances, initial encounter T50.905A Adverse effect of unspecified drugs, medicaments and biological substances, initial encounter T50.995A Adverse effect of other drugs, medicaments and biological substances, initial encounter T80.51XA Anaphylactic reaction due to administration of blood and blood products, initial encounter T80.52XA Anaphylactic reaction due to vaccination, initial encounter T80.59XA Anaphylactic reaction due to other serum, initial encounter Z88.0 Allergy status to penicillin Z88.1 Allergy status to other antibiotic agents status Z88.2 Allergy status to sulfonamides status Z88.3 Allergy status to other anti-infective agents status Z88.4 Allergy status to anesthetic agent status Z88.7 Allergy status to serum and vaccine status Z Allergy to eggs Printed on 9/21/2015. Page 8 of 10

9 ICD-10 Codes that DO NOT Support Medical Necessity Group 1 Paragraph: All diagnoses not listed in the "ICD-10-CM Codes that Support Medical Necessity" section of this LCD. Group 1 Codes: ICD-10 Additional Information Back to Top General Information Associated Information Documentation Requirements 1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request. 2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient. 3. The submitted medical record should support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code should describe the service performed. 4. Documentation must support the reasonable and necessary requirements as outlined under the coverage and limitations sections detailed above. Appendices Utilization Guidelines In accordance with CMS ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice. Sources of Information and Basis for Decision Contractor is not responsible for the continued viability of websites listed. Contractor Medical Directors Other Contractor Local Coverage Determinations, L32553 and L30471 Allergy Immunotherapy: A practice parameter third update. Annals of Allergy, Asthma and Immunology Cook PR, Bryant II JL, Davis WE, et al. Systemic reactions to immunotherapy: The American Academy of Otolaryngic Allergy Morbidity and Mortality Survey. Otolaryngology Head and Neck Surgery. June 1994; 110(6): Coifman RE, Cox LS, Letters to the Editor American Academy of Allergy, Asthma & Immunology member immunotherapy practice patterns and concerns. J Allergy Clin Immunol. 2007; 110(4): Epstein TG, Liss GM, Murphy-Berendts K, et al. AAAAI/ACAAI Surveillance Study of Subcutaneous Immunotherapy, Years : An Update on Fatal and Nonfatal Systemic Allergic Reactions. J Allergy Clin Immunol Pract. March/April 2014: E3. Hankin CS, Cox L, Lang D, et al. Allergen immunotherapy and health care cost benefits for children with allergic rhinitis: a large-scale, retrospective, matched cohort study. Annals of Allergy, Asthma & Immunology. Jan. 2010; Printed on 9/21/2015. Page 9 of 10

10 104: Hurst DS, Gordon BR, Fornadley JA, et al. Safety of home-based and office allergy immunotherapy: A multicenter prospective study. Otolaryngology Head and Neck Surgery. Nov. 199; 121(5): Schaffer FM, Naples AR, Ebeling M, et al. The safety of Self-administered allergen immunotherapy during the buildup and maintenance phases. International Forum of Allergy & Rhinology. 2014; 00 (00) 1-8. Shekelle PG, Woolf SH, Eccles M, et al. Developing Guiedlines. BMJ Feb., 1999; 318: Back to Top Revision History Information Please note: Most Revision History entries effective on or before 01/24/2013 display with a Revision History Number of "R1" at the bottom of this table. However, there may be LCDs where these entries will display as a separate and distinct row. Revision History Date Revision History Number Revision History Explanation 10/01/2015 R1 Updated Sources Back to Top Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Reason(s) for Change Other (Updated Sources) Public Version(s) Updated on 08/05/2015 with effective dates 10/01/ Updated on 06/24/2015 with effective dates 10/01/ Back to Top Keywords Read the LCD Disclaimer Back to Top Printed on 9/21/2015. Page 10 of 10