Lyme Disease Diagnosis and Treatment Mandate Form

500 EXCHANGE STREET, P ROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 06|01|2024 POLICY LAST REVIEWED: 01|22|2025 OVERVIEW This policy documents the state-mandated coverage guidelines for certain Lyme disease treatments (Rhode Island General Law 27-20-48). MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable Note: Laboratories are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician. Only the ordering physician shall be involved in the authorization, appeal or other administrative processes related to prior authorization/medical necessity.
In no circumstance shall a laboratory or a physician/provider use a representative of a laboratory or anyone with a relationship to a laboratory and/or a third party to obtain authorization on behalf of the ordering physician, to facilitate any portion of the authorization process or any subsequent appeal of a claim where the authorization process was not followed and/or a denial for clinical appropriateness was issued, including any element of the preparation of necessary documentation of clinical appropriateness. If a laboratory or a third party is found to be supporting any portion of the authorization process, BCBSRI will deem the action a violation of this policy and severe action will be taken up to and including termination from the BCBSRI provider network. If a laboratory provides a laboratory service that has not been authorized, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member. POLICY STATEMENT Medicare Advantage Plans and Commercial Products In accordance with Rhode Island General Law § 27-20-48, coverage is provided for diagnostic testing and long-term antibiotic treatment of chronic Lyme disease.
To qualify for payment, services must be ordered by a physician or other qualified healthcare professional after evaluation of symptoms, diagnostic test results, and response to treatment. Benefit payment for Lyme disease treatment will not be denied solely because such treatment may be characterized as unproven, experimental, or investigational. Commercial Products Some genetic testing services are not covered and a contract exclusion for any self-funded group that has excluded the expanded coverage of biomarker testing related to the state mandate, R.I.G.L. §27-19- 81 described in the Biomarker Testing Mandate policy. For these groups, a list of which genetic testing services are covered with prior authorization, are not medically necessary or are not covered because they are a contract exclusion can be found in the Coding section of the Genetic Testing Services or Proprietary Laboratory Analyses policies. Please refer to the appropriate Benefit Booklet to determine whether the member’s plan has customized benefit coverage. Please refer to the list of Related Policies for more information. COVERAGE Medical Coverage Policy | Lyme Disease Diagnosis and Treatment Mandate

500 EXCHANGE STREET, P ROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

Benefits may vary between groups/contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable benefits/coverage.

Although Rhode Island-mandated benefits generally do not apply to Plan 65, FEHBP, and Medicare Advantage Plans, Blue Cross & Blue Shield of Rhode Island follows this mandate for all products. Self- funded groups may or may not choose to follow state mandates.

BACKGROUND This policy documents the Rhode Island General Law (RIGL) 27-20-48 for certain Lyme disease treatments.

§ 27-20-48 Mandatory coverage for certain lyme disease treatments. – Every individual or group hospital or medical expense insurance policy or individual or group hospital or medical services plan contract delivered, issued for delivery, or renewed in this state on or after January 1, 2004 shall provide coverage for diagnostic testing and long-term antibiotic treatment of chronic lyme disease when determined to be medically necessary and ordered by a physician acting in accordance with chapter 37.5 of title 5 entitled "lyme disease diagnosis and treatment" after making a thorough evaluation of the patient's symptoms, diagnostic test results and response to treatment. Treatment otherwise eligible for benefits pursuant to this section shall not be denied solely because such treatment may be characterized as unproven, experimental, or investigational in nature.

Lyme disease is the most common vector-borne disease in the United States. Lyme disease is caused by the bacterium Borrelia burgdorferi and rarely Borrelia mayonii. It is transmitted to humans through the bite of infected blacklegged ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart, and the nervous system. Lyme disease is diagnosed based on symptoms, physical findings (e.g., rash), and the possibility of exposure to infected ticks. Laboratory testing is helpful if used correctly and performed with validated methods. Most cases of Lyme disease can be treated successfully with a few weeks of antibiotics. Steps to prevent Lyme disease include using insect repellent, removing ticks promptly, applying pesticides, and reducing tick habitat. The ticks that transmit Lyme disease can occasionally transmit other tick-borne diseases as well.

CODING Medicare Advantage Plans and Commercial Products The following CPT code(s) are used for testing for Lyme disease: 86617 Antibody; Borrelia burgdorferi (Lyme disease) confirmatory test (eg, Western Blot or immunoblot) 86618 Antibody; Borrelia burgdorferi (Lyme disease) 86619 Antibody; Borrelia (relapsing fever) 0041U Borrelia burgdorferi, antibody detection of 5 recombinant protein groups, by immunoblot, IgM
0042U Borrelia burgdorferi, antibody detection of 12 recombinant protein groups, by immunoblot, IgG
0043U Tick-borne relapsing fever Borrelia group, antibody detection to 4 recombinant protein groups, by immunoblot, IgM 0044U Tick-borne relapsing fever Borrelia group, antibody detection to 4 recombinant protein groups, by immunoblot, IgG 0301U Infectious agent detection by nucleic acid (DNA or RNA), Bartonella henselae and Bartonella quintana, droplet digital PCR (ddPCR) 0302U Infectious agent detection by nucleic acid (DNA or RNA), Bartonella henselae and Bartonella quintana, droplet digital PCR (ddPCR); following liquid enhancement 0316U Borrelia burgdorferi (Lyme disease), OspA protein evaluation, urine
0580U Borrelia burgdorferi, antibody detection of 24 recombinant protein groups, by immunoassay, IgG (New Code Effective 10/1/2025)

RELATED POLICIES Biomarker Testing Mandate
Genetic Testing Services Proprietary Laboratory Analyses (PLA)

PUBLISHED

500 EXCHANGE STREET, P ROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

Provider Update, March 2025 Provider Update, April 2024 Provider Update, September/October/November 2023 Provider Update, January/May 2022

REFERENCES

1. Rhode Island General Law (RIGL). 27-20-48 Mandatory coverage for certain lyme disease treatments. http://webserver.rilin.state.ri.us/Statutes/TITLE27/27-20/27-20-48.HTM

2. Centers for Disease Control and Prevention (CDC). Lyme Disease. http://www.cdc.gov/lyme/

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   This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber a greement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS