department of origin: integrated healthcare services 06/03

Department of Origin: Integrated Healthcare Services

Effective Date: 06/03/2021

Approved by: Pharmacy and Therapeutics Quality Management Subcommittee

Date Approved: 05/26/2021

Clinical Policy Document: Intravenous Antibiotic Therapy for Lyme Disease

Replaces Effective Clinical Policy Dated: N/A

Reference #: PC/K001

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PURPOSE: The intent of this clinical policy is to ensure services are medically necessary.

Please refer to the member’s benefit document for specific information. To the extent there is any inconsistency between this policy and the terms of the member’s benefit plan or certificate of coverage, the terms of the member’s benefit plan document will govern.

POLICY: Benefits must be available for health care services. Health care services must be ordered by a provider. Health care services must be medically necessary, applicable conservative treatments must have been tried, and the most cost-effective alternative must be requested for coverage consideration.

GUIDELINES: Medical Necessity Criteria - Must satisfy any of the following: I - II

I. Initial 4-week course of intravenous antibiotic (IVAB) therapy – must satisfy all of the following: A and

B

A. A definitive diagnosis of Lyme Disease as evidenced by both of the following: 1 and 2 1. Clinical presentation of signs and symptoms compatible with Lyme Disease; and

2. Positive serologic and/or cerebrospinal fluid (CSF) titer confirmed by two-tiered/modified two-

tiered testing methodology as recommended by the Centers for Disease Control and Prevention (CDC)6 - must satisfy both of the following: a – b

a. Step one - an IgG and IgM sensitive test by either of the following: 1) or 2)

1. Enzyme immunoassay (EIA)/enzyme-linked immunosorbent assay (ELISA); or

2. Indirect immunofluorescence assay (IFA).

b. Step two - must satisfy any of the following: 1) or 2)

1. IgM Western Blot; or

2. A second FDA-approved test IgG/IgM sensitive EIA/ELISA (maybe performed concurrently

or sequentially with the first EIA/ELISA)

[Note: Current FDA-approved tests: ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgM Test System, and the ZEUS ELISA Borrelia burgdorferi IgG Test System)

B. Presence of any of the following conditions: 1 - 4

1. Lyme arthritis – which persists after failure to respond to a 4-week course of appropriate oral antibiotic therapy; or








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2. Moderate to severe cardiac involvement – as evidenced by any of the following: a - d a. First degree heart block with P-R interval greater than 0.4 seconds; or b. Congestive heart failure; or c. Myopericarditis; or d. Second or higher degree atrio-ventricular block.

3. Neurologic involvement of Lyme disease (neuroborreliosis) – must satisfy any of

the following: a-c a. Encephalopathy or encephalomyelitis; or b. Meningitis; or c. Sensory or motor radiculoneuropathy or peripheral neuropathy (weakness and/or pain in

the extremities or chest).

4. Lyme disease in pregnant women – must satisfy any of the following: a or b a. Stage II Lyme disease (see Attachment A) with early dissemination documented by

organ-specific manifestations of infection (such as, but not limited to, arthritic, cardiac, or neurologic); or

b. Stage III late Lyme disease (see Attachment A) documented by findings of arthritis and/or neurologic complications (such as, but not limited to, encephalomyelitis and subacute encephalitis)

II. Repeat 4-week course of intravenous antibiotic therapy (only 1 repeat course allowed) – must satisfy

all of the following: A - C A. Criteria for initial 4-week course of intravenous antibiotic therapy is met using lab results obtained

within the past 3 months; and

B. Completion of initial 4-week course of intravenous antibiotic therapy; and

C. Evidence of any of the following: 1-3 1. Relapse of infection; or

2. Progression of Lyme disease organ damage; or

3. Finding of a new focus or type of organ damage.

EXCLUSIONS (not limited to): Refer to member’s Certificate of Coverage or Summary Plan Description.

The following tests for Lyme Disease are considered investigative (see Investigative List) I. Borrelia burgdorferi antibody index testing

II. Borrelia culture

III. C6 peptide ELISA assay (using recombinant VisE or peptide antigens of Borrelia burgdorferi)

IV. CD57+ lymphocyte counts

V. IgA screen (IFA)

VI. Lyme Dot Blot Assay for antigen








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VII. Polymerase chain reaction for identification or quantification of Lyme disease (B. burgdorferi)

VIII.Provocative testing (testing for B. burgdorferi after antibiotic provocation)

IX. Serum borreliacidal assay

X. Spirochetal DNA or RNA

XI. T-cell proliferation response assay

XII. 31kDa Epitope Test for IgM

XIII. Urine antigen assay

DEFINITIONS: Erythema migrans: Skin rash associated with Lyme disease

Lyme arthritis: Brief bouts of pain and swelling; may occur in one or more of the large joints, such as, but not limited to, the knees

BACKGROUND: Lyme disease in the United States is caused by Borrelia burgdorferi, transmitted by bites from ticks of the Ixodes scapularis and Ixodes pacificus species. Skin, joints, nervous system, and the heart are often involved in the clinical manifestations of Lyme disease. The most common cutaneous infection involving B. burgdorferi is called eyrthema migrans. Ticks from the I. scapularis specie may also cause human granulocytic anaplasmosis (HGA) and/or babesiosis.








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Prior Authorization: Yes, per network provider agreement.

CODING: HCPCS J0696 ceftriaxone (Rocephin) J0698 cefotaxime (Claforan)

ICD-10 diagnosis codes A69.20 – Lyme disease, unspecified A69.21 – Meningitis due to Lyme Disease A69.22 – Other neurologic disorders in Lyme disease A69.23 – Arthritis due to Lyme Disease A69.29 – Other conditions associates with Lyme Disease A69.8 – Other specified spirochetal infection A69.9 - Spirochetal infection, unspecified L90.4 – Acrodermatitis chronic atrophicans








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REFERENCES:

1. Integrated Healthcare Services Process Manual: UR015 Use of Medical Policy and Criteria 2. Clinical Policy: MP/C009 Coverage Determination Guidelines 3. Clinical Policy: MC/N007 Home Health Services, Intermittent 4. Minnesota Statute 62A.265 Coverage for Lyme Disease 5. Centers for Disease Control and Prevention. Lyme Disease. Page last reviewed March 5, 2021. Retrieved

from http://www.cdc.gov/lyme/ . Accessed 03-30-21. 6. Centers for Disease Control and Prevention. Diagnosis and Testing. Page last reviewed November 20,

2019. Retrieved from https://www.cdc.gov/lyme/diagnosistesting/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov %2Flyme%2Fdiagnosistesting%2Flabtest%2Ftwostep%2Findex.html. Accessed 03-30-21.

7. Centers for Disease Control and Prevention. Laboratory tests that are not recommended. Page last reviewed December 21, 2018. Retrieved from https://www.cdc.gov/lyme/diagnosistesting/labtest/otherlab/index.html. Accessed 03-30-21.

8. Lantos PM, Rumbaugh J, Beckenstedt LK, et al. Clinical Practice Guidelines by the Infectious Disease 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. Clinical Infectious Diseases. 2021;72(1):e1-e48. Retrieved from https://www.idsociety.org/practice-guideline/practice- guidelines/#/date_na_dt/DESC/0/+/. Accessed 03-30-21.

9. Hu, L. Diagnosis of Lyme disease. (Topic 7914 Version 29.0; last updated: 11/20/2019) In: Mitty J, ed. UpToDate. Waltham, Mass.: UpToDate; 2019. www.uptodate.com. Accessed 03-30-21 Hu, L. Diagnosis of Lyme disease. (Topic 7914 Version 29.0; last updated: 11/20/2019) In: Mitty J, ed. UpToDate. Waltham, Mass.: UpToDate; 2019. www.uptodate.com. Accessed 03-30-21.

DOCUMENT HISTORY: Created Date: 04/16/21 Reviewed Date: Revised Date:








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Attachment A

Stages of Lyme Disease

• Stage I (early Lyme disease) – may occur within days to weeks after being infected. Symptoms

may be one or more of the following: o Chills o Erythema migrans o Fatigue o Fever o Headache o Joint pain o Muscle pain o Swollen lymph nodes

• Stage II (early disseminated Lyme disease) – infection is beginning to spread, affecting certain body functions; may occur within weeks to months after being infected. Symptoms may be one or more of the following:

o Numbness and pain in arms or legs o Paralysis of facial muscles o Meningitis (fever, stiff neck, severe headaches) o Abnormal heart beat

• Stage III (late [chronic] Lyme disease) – may occur within weeks, months, or years after being infected in patients who either never received antibiotic treatment for Stage I Lyme disease or who did receive antibiotic treatment but did not rid of all of the bacteria. Symptoms may be one or more of the following:

o Chronic Lyme arthritis o Nervous system problems (such as, but not limited to, memory loss, difficulty

concentrating) o Chronic pain in muscles o Unrestful sleep

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PIC:Provides free aids and services to people with disabilities to communicate effectively with us, such as:

• Qualified sign language interpreters• Written information in other formats (large print, audio, accessible electronic formats, other formats)

Provides free language services to people whose primary language is not English, such as:• Qualified interpreters• Information written in other languages

If you need these services, contact a Grievance Specialist.

If you believe that PIC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with:

Grievance SpecialistPreferredOne Insurance CompanyPO Box 59212Minneapolis, MN 55459-0212Phone: 1.800.940.5049 (TTY: 763.847.4013)Fax: [email protected]

You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, a Grievance Specialist is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services200 Independence Avenue, SWRoom 509F, HHH BuildingWashington, D.C. 202011-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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department of origin: integrated healthcare services 06/03

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