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Lyme Disease Intravenous Treatment
Proprietary information of EmblemHealth. © 2025 EmblemHealth & Affiliates POLICY NUMBER LAST REVIEW MG.MM.ME.57cC2 May 9, 2025

Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the member meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request preauthorization or post-payment review. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. This clinical policy is not intended to pre-empt the judgment of the reviewing medical director or dictate to health care providers how to practice medicine. Health care providers are expected to exercise their medical judgment in rendering appropriate care. Health care providers are expected to exercise their medical judgment in rendering appropriate care.
EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary.
If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. Identification of selected brand names of devices, tests and procedures in a medical coverage policy is for reference only and is not an endorsement of any one device, test or procedure over another. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication.
EmblemHealth may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. EmblemHealth Services Company, LLC, has adopted this policy in providing management, administrative and other services to EmblemHealth Plan, Inc., EmblemHealth Insurance Company, EmblemHealth Services Company, LLC, and Health Insurance Plan of Greater New York (HIP) related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. Guideline (For lab testing, see Lyme Disease Testing Reimbursement Policy) I. Members with a confirmed Lyme disease diagnosis are eligible for an initial 2–4-week course of intravenous (IV) antibiotic therapy when the following criteria are met; any: A. Lyme arthritis that persists after failing to respond to a 4-week course of appropriate oral antibiotic therapy B. Lyme carditis —moderate to severe cardiac involvement as evidenced by any of the following:

1. 1st-degree heart block with P-R interval ≥ 300 milliseconds
2. Myopericarditis
3. 2nd- or higher degree atrio-ventricular block C. Neurologic involvement of Lyme disease (neuroborreliosis) as evidenced by any of the following:
4. Encephalomyelitis, based on MRI imaging, CSF pleocytosis, and no other cause found
5. Meningitis confirmed by CSF analysis showing a lymphocytic pleocytosis
6. Sensory/motor radiculoneuropathy or peripheral neuropathy (weakness and/or pain in the extremities or chest)

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Page 2 of 5 D. All cases of Lyme disease in pregnant women who exhibit symptoms and signs of any of the following:

1. Stage II Lyme disease with early dissemination documented by organ-specific manifestations of infection (arthritic, cardiac, or neurologic)

2. Stage III late Lyme disease documented by findings of arthritis and/or neurologic complications, such as encephalomyelitis and subacute encephalitis

   II. The following antibiotics constitute medically necessary IV therapy: A. Ceftriaxone (Rocephin®) B. Cefotaxime (Claforan®) C. Penicillin G D. Azithromycin (Zithromax®) — for members intolerant to b-lactam antibiotics Limitations and Exclusions I. Intravenous therapy with the following drugs is not considered medically necessary due to insufficient evidence of therapeutic value; any: A. Carbapenems (e.g., doripenem, ertapenem, imipenem, meropenem) B. First-generation cephalosporins (e.g., cefazolin) C. Azole antifungals D. Fluoroquinolones (e.g., levofloxacin, moxifloxacin)

   II. Repeat 2–4-weeks of outpatient IV therapy is considered medically necessary when the following criteria are met; all: A. The member has met the criteria for an initial course of intravenous antibiotic therapy, using lab results obtained within the past 3 months B. The member has completed an initial course of appropriate intravenous antibiotic therapy C. The member has objective evidence of either relapse of infection, progression of Lyme disease organ damage, and/or the finding of a new focus or type of organ damage

   III. Intravenous therapy for the following indications is not considered medically necessary due to insufficient evidence of therapeutic value; any: A. Early Lyme disease (i.e., erythema migrans without any systemic manifestations) B. Flu-like syndrome (fatigue, fever, headache, mildly stiff neck, arthralgias, and myalgias) C. Initial treatment of Lyme arthritis
   D. Non-specific subjective symptoms, such as persistent, chronically debilitating fatigue (chronic fatigue syndrome), difficulty in concentrating, musculoskeletal pain (fibromyalgia), and headache E. Pregnant woman presenting with localized Lyme disease manifested as a single lesion of erythema migrans without any other symptoms suggestive of disseminated disease F. Treatment of "post-Lyme disease" syndrome (i.e., persistent fatigue) G. Treatment of individuals with systemic symptoms without serologic or cerebrospinal fluid (CSF) studies confirming Lyme disease H. Prophylactic treatment of asymptomatic members when the sole evidence of Lyme disease is a positive immunologic test (ELISA, IFA, or Western blot) I. Treatment of persistent Lyme-associated arthritis after 2 prior courses of antibiotic therapy

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Page 3 of 5 J. Mild cardiac involvement of Lyme disease as evidenced by any of the following:  Transient ST-T depression  T-wave changes IV. Repeat or prolonged courses of IV antibiotics (> 8 weeks) has not been shown to improve net health outcomes and are not considered medically necessary

V. The following treatments are not considered medically necessary treatment for Lyme disease due to insufficient evidence of therapeutic value: A. Chelation
B. Hyperbaric oxygen therapy C. Singlet oxygen therapy D. Intravenous ascorbic acid E. Intravenous magnesium Procedure Codes
96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour 96366 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour
(List separately in addition to code for primary procedure) 96367 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); additional sequential infusion of a new drug/substance, up to 1 hour (List separately in addition to code for primary procedure) 96368 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); concurrent infusion (List separately in addition to code for primary procedure) 96369 Subcutaneous infusion for therapy or prophylaxis (specify substance or drug); initial, up to 1 hour, including pump set- up and establishment of subcutaneous infusion site(s) 96370 Subcutaneous infusion for therapy or prophylaxis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure) 96371 Subcutaneous infusion for therapy or prophylaxis (specify substance or drug); additional pump set-up with establishment of new subcutaneous infusion site(s) (List separately in addition to code for primary procedure) 96374 Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intravenous push, single or initial substance/drug 96375 Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); each additional sequential intravenous push of a new substance/drug (List separately in addition to code for primary procedure) 93676 Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); each additional sequential intravenous push of the same substance/drug provided in a facility (List separately in addition to code for primary procedure) 99601 Home infusion/specialty drug administration, per visit (up to 2 hours); 99602 Home infusion/specialty drug administration, per visit (up to 2 hours); each additional hour (List separately in addition to code for primary procedure)

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Page 4 of 5 References

1. Lantos PM, Rumbaugh J, Bockenstedt LK, Falck-Ytter YT, Aguero-Rosenfeld ME, Auwaerter PG, Baldwin K, Bannuru RR, Belani KK, Bowie WR, Branda JA, Clifford DB, DiMario FJ Jr, Halperin JJ, Krause PJ, Lavergne V, Liang MH, Cody Meissner H, Nigrovic LE, Nocton JJJ, Osani MC, Pruitt AA, Rips J, Rosenfeld LE, Savoy ML, Sood SK, Steere AC, Strle F, Sundel R, Tsao J, Vaysbrot EE, Wormser GP, Zemel LS. Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR): 2020 Guidelines for the Prevention, Diagnosis, and Treatment of Lyme Disease. Arthritis Care Res (Hoboken). 2021 Jan;73(1):1-9. doi: 10.1002/acr.24495. Epub 2020 Nov 29. PMID:
3. Lyme disease: diagnosis and management. National Guideline Centre (UK). Source London: National Institute for Health and Care Excellence (UK); 2018 Apr. National Institute for Health and Care Excellence: Clinical Guidelines.
4. Lyme disease: diagnosis and management. Ross Russell AL, Dryden MS, Pinto AA, Lovett JK. Pract Neurol. 2018 Dec;18(6):455-
5. doi: 10.1136/practneurol-2018-001998. Epub 2018 Oct 3.
6. Neuroborreliosis and Neurosyphilis. Halperin JJ. Continuum (Minneap Minn). 2018 Oct;24(5, Neuroinfectious Disease):1439-
7. doi: 10.1212/CON.0000000000000645.
8. Clin Microbiol Infect. 2018 Feb;24(2):118-124. doi: 10.1016/j.cmi.2017.08.025. Epub 2017 Sep 5. To test or not to test? Laboratory support for the diagnosis of Lyme borreliosis: a position paper of ESGBOR, the ESCMID study group for Lyme borreliosis. Dessau RB, van Dam AP, Fingerle V, Gray J, Hovius JW, Hunfeld KP, Jaulhac B, Kahl O, Kristoferitsch W, Lindgren PE, Markowicz M, Mavin S, Ornstein K, Rupprecht T, Stanek G, Strle F.
9. Clinical Manifestations and Treatment of Lyme Disease. Sanchez JL. Clin Lab Med. 2015 Dec;35(4):765-78. doi: 10.1016/j.cll.2015.08.004. Epub 2015 Sep 26. Review.
10. Infect Dis Clin North Am. 2015 Jun;29(2):269-80. doi: 10.1016/j.idc.2015.02.004. Diagnosis and treatment of Lyme arthritis. Arvikar SL, Steere AC.
11. Mead P, Petersen J, Hinckley A. Updated CDC Recommendation for Serologic Diagnosis of Lyme Disease. MMWR Morb Mortal Wkly Rep 2019;68:703. DOI: http://dx.doi.org/10.15585/mmwr.mm6832a4external icon.
12. Specialty matched clinical peer review. Revision History Company(ies) DATE REVISION EmblemHealth May 9, 2025 Transferred policy content to individual company branded template EmblemHealth/ConnectiCare Jun. 9, 2023 Changed policy title from “Lyme Disease Diagnosis and Treatment” to “Lyme Disease Intravenous Treatment”
    Added hyperlink for lab test component to Lyme Disease Testing Reimbursement Policy
    Clarified that repeat or prolonged courses of IV antibiotics > 8 weeks (previously 4 weeks) is not considered medically necessary EmblemHealth/ConnectiCare Jan. 8, 2021 Expanded definition section regarding I scapularis and Borrelia miyamotoi Added link to the 2020 Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR) Guidelines for the Prevention, Diagnosis and Treatment of Lyme Disease to diagnostic testing Modified initial/repeat IV therapy treatment course from greater than four weeks to two-four weeks Clarified that early Lyme disease refers to erythema migrans without any systemic manifestations

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Page 5 of 5 Added that diagnostic testing is not considered medically necessary unless recommended within the IDSA/AAN/ACR Clinical Practice Guidelines ConnectiCare Dec. 12, 2020 ConnectiCare adopts the clinical criteria of its parent corporation EmblemHealth EmblemHealth Oct. 13, 2017 Removed congestive heart failure from Lyme carditis indication sub-criteria list; clarified and simplified neurologic involvement sub- criteria; removed 1st degree heart block and left ventricular dysfunction from mild cardiac involvement sub-criteria list