Non-Quantitative Treatment Limitation Parity Testing (Experimental/Investigational Determinations) Form

Clinical Policy

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Clinical Policy: Non-Quantitative Treatment Limitation Parity Testing of Experimental/Investigational Determinations Reference Number: CP.FC.48 Last Review Date: 1/2026

Step 1: Describe the NQTL’s requirements and associated procedures Services/benefit(s) to which the approval protocols for experimental/investigational service coverage for of all mental health or substance use disorder and medical or surgical benefits to which the NQTL applies or for which it does not apply.

Inpatient: This NQTL assesses the process by which Fidelis makes a determination as to whether a benefit or service for all mental health or substance use disorder and medical or surgical benefits to which the NQTL applies or for which it does not apply and is considered experimental or investigational. If a benefit or service is determined to be experimental/investigational it will not be covered by Fidelis.

As per Centene policy CP.MP.36 Experimental Technologies:
It is the policy of health plans affiliated with Centene Corporation® and Centene Advanced Behavioral Health that all coverage determinations regarding technologies (i.e., drugs, procedures, devices, services, or supplies) that are or may be considered experimental or investigational must be considered on a case-by-case basis by a physician or ad hoc committee and must be made in accordance with the Benefit Plan Contract provisions and applicable state and federal requirements.

Fidelis defines Experimental and Investigational Treatments to be services that are not covered because they are determined to be experimental or investigational in nature. When Fidelis reviews a request for medical necessity, Fidelis uses a hierarchy of evidence outlined in our Medical Necessity Policy. If decision support tools (e.g. Medicare NCDs and LCDs, NY State Medicaid coverage determination, Centene or Fidelis Policies, MCG current edition, Hayes and UpToDate) state it is experimental or investigational, it is denied. Determinations of whether a treatment or service is experimental or investigational, and the specific circumstances (if any) under which it is covered, are set forth in Fidelis’ Coverage Policies.

Determining experimental/investigational services
Fidelis Care uses the same processes and strategies to determine whether mental health / substance use and medical / surgical services, items, or medications are deemed experimental or investigational, as written, and the as written processes and strategies that govern the coverage of experimental/investigational mental health / substance use and medical / surgical services items, or medications.

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“Experimental or investigative services" means a drug, device, medical treatment, diagnostic procedure, technology, or other procedure (collectively, “service”) for which reliable data are insufficient to conclude the following:

1. Safety: the chances of complications and their likely severity are reasonable relative to approved treatments or non-treatment under the current standard of care

2. Effectiveness: the service is effective in practice outside of a research setting

3. Effect on Health Outcome: the service improves health over time

   Some services have been determined to be non-experimental or investigative (and therefore covered) in certain circumstances. The specific circumstances under which these services have been determined by the Plan to be non-experimental or investigative are set forth in the Plan’s coverage policies.

   For more information on the development of Fidelis’ medical necessity criteria and clinical coverage guidelines, see Fidelis’ Clinical Policy: Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines (Reference Number CP.FC.45).

   Outpatient: Same as inpatient.

   Emergency: N/A

   Prescription drug: Not applicable

   Step 2: Identify factors.

   Inpatient:

   The following factors are applied for both M/S and MH/SUD benefits using a hierarchy of evidence outlined in our Medical Necessity Policy.:

4. Unproven clinical efficacy
5. Market approval

6. Safety and effectiveness

   Outpatient: Same as inpatient.

   Emergency: N/A

   Prescription drug: Not applicable

   Step 3: Identify and describe evidentiary standards and other evidence relied upon.

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Inpatient: Fidelis Care uses the same policies and procedures to identify services, item, or medications for review to determine if they are experimental or investigational for mental health / substance use disorder benefits and for medical/surgical benefits as described below.

As per Centene policy CP.MP.36 Experimental Technologies:

A technology is considered experimental or investigational if it meets any of the following criteria:

A. Unproven clinical efficacy: the benefit or service is considered unproven in terms of its clinical efficacy if it is currently the subject of active and credible evaluation (e.g., clinical trials or research) to determine:

1. Clinical efficacy, or
2. Therapeutic value or beneficial effects on health outcomes, or

3. Benefits beyond any established medical based alternatives.
   If a benefit/service meets this definition, it is considered experimental/investigational.

   B. Market approval: It does not have final clearance from applicable governmental regulatory bodies (such as the US Food and Drug Administration "FDA") and unrestricted market approval for use in the treatment of a specified medical condition or the condition for which authorization of the service is requested and is the subject of an active and credible evaluation. If a benefit/service meets this definition, it is considered experimental/investigational.

   C. Safety and effectiveness: The most recent peer-reviewed scientific studies published or accepted for publication by nationally recognized medical journals do not conclude, or are inconclusive in finding, that the service is safe and effective for the treatment of the condition for which authorization of the service is requested. If a benefit/service meets this definition, it is considered experimental/investigational.

   Hierarchy of sources and evidentiary standards: The criteria listed below should be weighed when evaluating the medical necessity of a technology that is or may be experimental or investigational. Where medical necessity of a technology is confirmed under this policy, steps should be taken to ensure that the technology is furnished by a participating or in-state provider to the extent possible.

   A. The technology should have final approval from appropriate governmental regulatory bodies. Regulatory bodies include the U.S. Food and Drug Administration (FDA) or any other governmental body with authority to regulate the technology. The indication for the technology under review does not need to be the same indication for which the technology has been approved.

   If a request is for coverage of routine costs as part of a clinical trial, see CP.MP.94 Clinical Trials.

   B. At least two studies published in peer-reviewed medical literature should be available that would support conclusions regarding the effect of the technology and its likely net health impact. Such studies must, by the standards of accepted medical research, be well-designed and well-conducted investigations yielding quality and consistent results, and the results of such studies should

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demonstrate the effect the technology will have on the disease, injury, illness, or condition in question.

The opinions and evaluations of national medical associations, consensus panels, and other technology evaluation bodies, or other specialists or professionals who are subject matter experts with respect to the technology, may be taken into consideration according to the scientific quality of the supporting evidence and rationale for such opinions and evaluations.

C. The technology should be used to improve net health outcome of a severely disabling or life- threatening condition. The health benefits of the technology must outweigh any harmful effects or risks to the member.

D. Other established treatment alternatives to the technology should have been exhausted and failed or no established treatment exists.

E. The improvement to be gained by employing the technology should be attainable outside the control setting (i.e., in practice).

F. In the case of diagnostic procedures, it is anticipated that the results of the procedure will help determine the best plan of care. There must be some potential intervention or alteration to the current plan of care based on the diagnostic results.

G. The member fully understands the risks and benefits regarding the requested technology or treatment and has given informed consent.

For more information on the development of Fidelis’ medical necessity criteria and clinical coverage guidelines, see Fidelis’ Clinical Policy: Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines (Reference Number CP.FC.45).

Outpatient: Same as inpatient.

Emergency: N/A

Prescription drug: Not applicable

Step 4: Comparative analysis of as written processes and strategies.

Inpatient: Fidelis Care uses the same processes and strategies to determine whether mental health / substance use and medical / surgical services, items, or medications are deemed experimental or investigational, as written, and the as written processes and strategies that govern the coverage of experimental/investigational mental health / substance use and medical / surgical services items, or medications.

Comparable Processes, Factors and Evidentiary Standards

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Fidelis defines Experimental and Investigational Treatments to be services that are not covered because they are determined to be experimental or investigational in nature. When Fidelis reviews a request for medical necessity, Fidelis uses a hierarchy of evidence outlined in our Medical Necessity Policy. If decision support tools (e.g. Medicare NCDs and LCDs, NY State Medicaid coverage determination, MCG current edition, Hayes and UpToDate) state it is experimental or investigational, it is denied. This process is the same for MH/SUD and M/S services.

Moreover, Fidelis uses the same factors in making a determination as to whether a given service is considered experimental/investigational: (1) Unproven clinical efficacy, (2) Market approval, and (3) Safety and effectiveness. These factors, and the sources and evidentiary standards for these factors are identical for M/S and MH/SUD services, and thus, are comparable and no more stringent.

Composition of Decision Making Staff Fidelis Care’s team of licensed Medical Directors review the criteria in place to guide medical necessity determination (including the guidelines for making experimental and investigational determinations). The team represents a diverse background of specialties including: • Pediatrics • Emergency Medicine • Allergy and Immunology • Geriatric Medicine • Internal Medicine • General Psychiatry/Addiction Medicine • Cardiovascular Disease • Family Practice • Plastic Surgery • Child and Adolescent Psychiatry • Endocrinology and Metabolism • Preventive Medicine • Pain Medicine • Physical Medicine and Rehabilitation • Hospice and Palliative Medicine

Only appropriate practitioners can make the decision to deny coverage of a requested service based on medical necessity guidelines. Practitioner types appropriate for making the following types of denial decisions include*: Provider type allowed to make denial decisions: Provider Type Denial Decision Physicians, all types Medical, behavioral healthcare, pharmaceutical, dental, chiropractic, vision, and physical therapy denials Doctoral-level clinical psychologists or
certified addiction-medicine specialists Behavioral healthcare denials

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Dentists Dental denials Chiropractors Chiropractic denials Physical therapists Physical therapy denials *State mandates may alter which practitioner types are appropriate for denial decisions.

This is true for both MH/SUD and M/S services, and the number of staff members allocated, time allocated, and qualifications of staff involved are comparable and no more stringent for MH/SUD and M/S services. Therefore, the processes and strategies used to design the medical necessity criteria, as written, for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used to design the medical necessity criteria as written, for medical/surgical benefits.

Outpatient: Same as inpatient.

Emergency: N/A

Prescription drug: Not applicable

Step 5: Comparative analysis of in operation processes and strategies.

Inpatient: Fidelis uses the same operations measures for monitoring experimental and investigational restrictions as those operations measures indicated in Fidelis’ Medical Necessity Criteria and Clinical Coverage Guidelines NQTL.

M/S Operations Measure #1: Fidelis reviews all policies and procedures, including the medical necessity policies (and those for experimental and investigational determinations) outlined in this NQTL, at least yearly in order to ensure the processes and strategies used in applying the experimental/investigational criteria for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used in applying the experimental/investigational criteria, in operation, for medical surgical benefits. Fidelis accomplishes this through committee review. Fidelis’ clinical policy committee reports up to the UM sub committee (UM subcommittee is described above in Step 4). The process by which this review is conducted is detailed as follows:

Physical Health Policy Creation A. Attendance at the Monthly Centene Clinical Policy Committee

1. Participate in monthly meeting for CPC for policy reviews via Zoom
2. Complete pre-CPC meeting survey via email
3. Complete Post CPC meeting survey via email B. Fidelis review of Policies (new policies and updates)
4. Clinical Policy Workgroup reviews new or updating Centene Policies a. Make recommendations to Utilization Management Sub- Committee (UMSC) i. Accept as is

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ii. Reject due to State requirements/benefits/provider contracts iii. Modify due to State requirements/benefits/provider contracts and create new Fidelis policy iv. Accept, but convert to payment policy b. Prepare materials for UMSC i. Provide Policy ii. Provide brief description iii. Participate in quarterly UMSC meeting via Zoom c. Notify Clinical policy workgroup of UMSC decision i. Work with Policy Production team on timing of upload into MCG ii. Determine implementation date for clinical reviews d. Submit policy to Communications to publish on fideliscare.org and Centene SharePoint site. e. Post policy on Medical Director wiki

2. Clinical Policy determines Fidelis policy is needed a. Modification of existing Centene Policy including State specific regulatory or contractual requirements b. Develop De Novo policy i. New benefit requires policy ii. New and emerging technologies iii. New uses for existing technologies iv. Coverage issues relating to new and existing technologies v. Clinical guidelines for the evaluation and treatment of specific conditions
   vi. Clinical/medical criteria or information used in pre- or post-service review vii. Lack of clear criteria for review noted by RNs and/or MDs c. Prepare materials for UMSC i. Provide Policy ii. Provide brief description iii. Participate in quarterly UMSC meeting via Zoom d. Notify Clinical policy workgroup of UMSC decision i. Work with Policy Production team on timing of upload into MCG ii. Determine implementation date for clinical reviews e. Submit policy to Communications to publish on fideliscare.org and Centene SharePoint site. f. Post policy on Medical Director wiki
3. Annual review of Policies a. Perform review of all Centene and Fidelis policies, and provide necessary updates. b. Notify UMSC of updates

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c. Notify Clinical policy workgroup of UMSC decision i. Work with Policy Production team on timing of upload into MCG ii. Determine implementation date for clinical reviews d. Submit policy to Communications to publish on fideliscare.org and Centene SharePoint site. e. Post policy on Medical Director wiki

4. Upload Fidelis policies (New and updates) on Centene SharePoint site: https://cnet.centene.com/sites/PPLS/SitePages/ClinicalHome.aspx C. Review new policy request or policy change request submitted by provider(s)
5. Work with provider as to why the request is necessary
6. Request evidence to support the request
7. Appoint Clinical Policy Workgroup Subcommittee to review the request
8. Subcommittee makes recommendations to Clinical Policy Workgroup D. Work with Provider Relations to determine if prior notification of 30 days is required E. Work with Coding and Configuration to make necessary changes in Claims/Facets

9. Submit tickets for changes through request central if needed F. For policies that are recommended to convert to payment policies, work with Payment Integrity team to modify clinical policy to payment policy. G. Keep Policy tracker updated

   Clinical Policy Committee The Clinical Policy Committee ensures that clinical policies provide a guide to medical necessity, are reviewed and approved by appropriately qualified physicians, and are available to all Centene Health Plans.

   Clinical policies provide a guide to medical necessity. Benefit determinations should be based in all cases on the applicable contract provisions governing plan benefits (“Benefit Plan Contract”) and applicable state and federal requirements, as well as applicable plan-level administrative policies and procedures. To the extent there are any conflicts between these policies and the Benefit Plan Contract provisions, the Benefit Plan Contract provisions will control.

   Clinical policies reflect current scientific research and evidence-based clinical standards.
   Clinical policies are not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care and are solely responsible for the medical advice and treatment given to members. All clinical policies are available to providers in compliance with all federal, statutory and regulatory requirements and upon request. I. Purpose A. The Centene Corporate Chief Medical Officer (CMO) or his/her designee is responsible for establishing and maintaining a Clinical Policy Committee (CPC) composed of physicians and other medical and operational representatives as appropriate from Corporate Medical Management and each Plan to assist in the

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identification of need, development, revision, and/or review of clinical policy. All corporate clinical policies require approval by the CPC. Physicians participating in the CPC shall be board-certified and shall be licensed in good standing in at least one state.
B. Clinical policies include medical, and durable medical equipment and devices. These policies include but are not limited to:

1. New and emerging technologies
2. New uses for existing technologies
3. Coverage issues relating to new and existing technologies
4. Clinical guidelines for the evaluation and treatment of specific conditions

5. Clinical/medical criteria or information used in pre- or post-service review C. The CMO or designee performs an annual review of all existing corporate clinical policies to determine continued applicability and appropriateness. In connection with this annual review, the CMO or designee is responsible for identifying which policies require revisions. The CMO or designee shall send any such policies to the CPC to oversee the revision process and for subsequent re-approval.

   II. Membership The CMO or designee recruits and replaces, as needed, CPC members to maintain a committee that includes: A. Voting members:

6. One Medical Director from each Plan (at minimum);
7. Senior Corporate Medical Directors B. Non-voting members:
8. One representative from each Plan’s medical operations department
9. Corporate clinical policy leadership
10. Corporate Medical Management Staff C. Ad hoc advisors
11. Representatives from Centene subsidiaries
12. Internal legal counsel
13. Plan compliance directors

14. Outside experts and/or relevant interested parties depending upon the specialty area or special needs of the clinical policy.

    III. Committee Maintenance and Oversight A. The CMO or designee acts as the chairperson for meetings and activities performed by the CPC (Committee Chair). The Corporate Director of Clinical Policy reports to the Committee Chair. B. The Corporate Director of Clinical Policy oversees the Clinical Policy Department which is tasked with the following responsibilities in connection with the development and approval of clinical policies:

15. Coordinating research and development of clinical policies, which includes: a. Prioritizing all inquiries for new corporate policies and maintaining an electronic log of all requests for research and new policies with the requestor and subject of review.

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Highest priority is given to inquires based on open medical management cases such as pending authorizaitons or appeals cases. Response to these requests typically occurs within 24 hours. Priority then continues based on requests originating from providers or members, needs identified through financial analysis, followed by inquiries by vendors and technologies identified through trade publications.
b. Conducting prelimary review of topics as follows: i. A critical appraisal of the current published medical literature from peer-reviewed publications including systematic reviews, randomized controlled trials, cohort studies, case control studies, and diagnostic test studies with statistically sound methods. ii. Evidence-based guidelines developed by national organizations and recognized authorities. iii. Opinions and assessments by nationally recognized medical associations including physician specialty societies, consensus panels, or other nationally recognized research or technology assessment organizations such as Hayes, UpToDate, or ECRI.
iv. Reports and publications of government agencies such as the Food and Drug, Administration (FDA), Centers for Disease Control (CDC), or National Institutes of Health (NIH).
v. External review organization recommendations. c. Conveying the findings of the preliminary review to the requestor within the priority-based time frame. In cases of open medical management decisions, the requestor will use the information provided by the clinical policy staff and the specifics of the particular case to render a decision. Preliminary review findings are saved in an electronic file for future policy development. d. For topics identified through medical management needs, if two requests for the same topic are submitted, a formal medical policy may be developed.
Requests identified through financial analysis will follow this policy development process.
i. The clinical policy staff utilizes the preliminary research to draft a policy. Relevant CPT, HCPCS and ICD-10 codes are identified and included in the policy. A review of historical handling and/or payment of the policy topic is also conducted to share with the CPC as appropriate. ii. Opinions from external physicians are solicited as appropriate, including behavioral health physicians. The policy is sent for CPC review and approval.
iii. Subsequent to each new policy approval, the clinical policy staff sends a notice to all medical directors and medical management leadership to inform them of new policies that have been approved by the CPC.
iv. The completed policies are reviewed annually or updated more frequently as dictated by current medical literature, medical director or other relevant staff requests and appeals analysis.

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v. Completed policies are posted on CNET and in Adobe Experience Manager for access by internal staff and for plans to link to plan websites for providers. e. Communication of these policies to provider networks is arranged by the plan marketing or provider network department.

2. Coordinating activities of the CPC including, but not limited to, the review, revision, approval, and maintenance processes of all corporate clinical policies.
   This includes scheduling meetings, sending necessary agendas and attachments, documenting meeting minutes, clinical policy reference number assignment, and the maintenance of such documents in electronic files and within the organizational internal database.
3. Generating reports reflecting CPC activity on a quarterly basis, or more frequently as needed, for the Committee Chair.
4. Notifying all relevant persons/departments and health plans regarding approved policies and related materials through email, including: a. Claim support service teams for dissemination to IS and claims. The clinical policy team offers direction/coordination for any system needs to support the clinical policy.
   b. Corporate Medical Management VPs and Corporate medical auditing and training teams for dissemination and auditing. c. CPC members, plan medical management VPs and directors, and other health plan contacts for dissemination to their plan UM personnel. This includes notification to plan respresentatives for inclusion in the plan UM or QI committee responsible for plan level policy approval. Marketing and/or provider relations are included for appropriate provider notification of policy changes.

5. Facilitating training, as needed, with the corporate Medical Management Training Department.

   IV. Meeting Frequency A. CPC meetings are held, at minimum, on a quarterly basis. Frequency is dependent upon clinical policy revision cycles and/or clinical policy need (as determined by the CMO or designee). B. Meetings may be held in a physical location or through the use of alternative media as determined by the participation of members from remote locations or by the urgency of the clinical policy. Such media include video, telephonic conference call, or email.

   V. Committee Member Activities and Responsibilities: A. Identification of new subjects to consider for clinical policy development can occur in the following ways:

6. Through UM authorization requests;
7. New technologies identified through trade publications;
8. Inquiries from providers and vendors;
9. Review of appeals cases;

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5. Suggestion of the Medical Policy Governance Team; B. Review of clinical policies which includes:
6. New clinical policy drafts;
7. Policies due for scheduled review;
8. Updates or revisions to existing policies outside of the scheduled review due to advances or changes in standards of care, new information, missing information or content error;
9. Updates regarding the status of any policies under review;

10. Policy and prioritization requests for new clinical policies;

    M/S Operations Measure #2: Fidelis reviews the meeting minutes of the clinical policy committee and the UM sub committee on a quarterly basis in order to ensure the processes and strategies used in applying the experimental/investigational criteria for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used in applying the experimental/investigational criteria, in operation, for medical surgical benefits.

    MH/SUD:

    MH/SUD Operations measure #1: Fidelis reviews all policies and procedures, including the medical necessity policies outlined in this NQTL (including those for experimental/investigational determinations), at least yearly in order to ensure the processes and strategies used in applying the experimental/investigational criteria for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used in applying the experimental/investigational criteria, in operation, for medical surgical benefits. Fidelis accomplishes this through committee review. Fidelis’ clinical policy committee reports up to the UM Sub-Committee. The Utilization Management Subcommittee e is comprised of network practitioners who give input into provider and member health education materials, clinical and preventive health guidelines, quality improvement initiatives, and policies and procedures that may impact providers.

    The process by which this review is conducted for behavioral health is detailed as follows:

    Behavioral Health (BH) Clinical Policies A. Attendance at the Centene Quarterly Behavioral Health Clinical Policy Committee B. BH Policy Committee review of Policies (new policies and updates)

11. BH Policy Committee review of Centene Policies (new policies and updates)
    a. Make recommendations to Utilization Management Sub-Committee (UMSC) i. Accept as is ii. Reject due to state requirements/benefits/provider contracts iii. Modify due to State requirements/benefits/provider contracts and create new Fidelis policy iv. Accept, but convert to payment policy b. Prepare materials for UMSC i. Provide Policy

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ii. Provide brief description c. Notify BH Policy Committee of UMSC decision i. Work with Policy Production team on timing of upload into MCG ii. Determine implementation date for clinical reviews d. Submit policy to Communications to publish on fideliscare.org e. Post policy on Medical Director wiki

2. BH Policy Committee determines Fidelis policy is needed a. Modification of existing Centene Policy including State specific regulatory or contractual requirements b. If applicable, Develop De Novo policy
   i. New benefit requires policy ii. New and emerging technologies iii. New uses for existing technologies iv. Coverage issues relating to new and existing technologies v. Clinical guidelines for the evaluation and treatment of specific conditions
   vi. Clinical/medical criteria or information used in pre- or post- service review vii. Lack of clear criteria for review noted by CMs and/or MDs c. Prepare materials for UMSC i. Provide Policy ii. Provide brief description d. Notify BH Policy Committee of UMSC decision i. If applicable, work with Policy Production team on timing of upload into MCG ii. Determine implementation date for clinical reviews e. Submit policy to Communications to publish on fideliscare.org f. Post policy on Medical Director wiki
3. Annual review of Policies a. Perform review of all Centene and Fidelis BH policies, and provide necessary updates. b. Notify UMSC of updates c. Notify BH Policy Committee of UMSC decision i. If applicable, work with Policy Production team on timing of upload into MCG ii. If applicable, determine implementation date for clinical reviews d. Submit policy to Communications to publish on fideliscare.org e. Post policy on Medical Director wiki
4. Upload Fidelis policies (New and updates) on Centene SharePoint site: https://cnet.centene.com/sites/PPLS/SitePages/ClinicalHome.aspx C. Review new policy request or policy change request submitted by provider(s)
5. Work with provider as to why the request is necessary
6. Request evidence to support the request
7. Appoint Clinical Policy Workgroup Subcommittee to review the request
8. Subcommittee makes recommendations to Clinical Policy Workgroup

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D. If applicable, work with Provider Relations to determine if prior notification of 30 days is required E. If applicable, work with Coding and Configuration to make necessary changes in Claims/Facets

1. Submit tickets for changes through request central if needed F. For policies that are recommended to convert to payment policies, work with Payment Integrity team to modify clinical policy to payment policy. G. Keep Policy tracker updated

   Clinical Policy Committee The Clinical Policy Committee ensures that clinical policies provide a guide to medical necessity, are reviewed and approved by appropriately qualified physicians, and are available to all Centene Health Plans.

   Clinical policies provide a guide to medical necessity. Benefit determinations should be based in all cases on the applicable contract provisions governing plan benefits (“Benefit Plan Contract”) and applicable state and federal requirements, as well as applicable plan-level administrative policies and procedures. To the extent there are any conflicts between these policies and the Benefit Plan Contract provisions, the Benefit Plan Contract provisions will control.

   Clinical policies reflect current scientific research and evidence-based clinical standards.
   Clinical policies are not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care and are solely responsible for the medical advice and treatment given to members. All clinical policies are available to providers in compliance with all federal, statutory and regulatory requirements and upon request. I. Purpose A. The Centene Corporate Chief Medical Officer (CMO) or his/her designee is responsible for establishing and maintaining a Clinical Policy Committee (CPC) composed of physicians and other medical and operational representatives as appropriate from Corporate Medical Management and each Plan to assist in the identification of need, development, revision, and/or review of clinical policy. All corporate clinical policies require approval by the CPC. Physicians participating in the CPC shall be board-certified and shall be licensed in good standing in at least one state.
   B. Clinical policies include medical, and durable medical equipment and devices. These policies include but are not limited to:

2. New and emerging technologies
3. New uses for existing technologies
4. Coverage issues relating to new and existing technologies
5. Clinical guidelines for the evaluation and treatment of specific conditions
6. Clinical/medical criteria or information used in pre- or post-service review C. The CMO or designee performs an annual review of all existing corporate clinical policies to determine continued applicability and appropriateness. In connection with this annual review, the CMO or designee is responsible for identifying which policies

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require revisions. The CMO or designee shall send any such policies to the CPC to oversee the revision process and for subsequent re-approval.

II. Membership The CMO or designee recruits and replaces, as needed, CPC members to maintain a committee that includes: A. Voting members:

1. One Medical Director from each Plan (at minimum);
2. Senior Corporate Medical Directors B. Non-voting members:
3. One representative from each Plan’s medical operations department
4. Corporate clinical policy leadership
5. Corporate Medical Management Staff C. Ad hoc advisors
6. Representatives from Centene subsidiaries
7. Internal legal counsel
8. Plan compliance directors

9. Outside experts and/or relevant interested parties depending upon the specialty area or special needs of the clinical policy.

   III. Committee Maintenance and Oversight A. The CMO or designee acts as the chairperson for meetings and activities performed by the CPC (Committee Chair). The Corporate Director of Clinical Policy reports to the Committee Chair. B. The Corporate Director of Clinical Policy oversees the Clinical Policy Department which is tasked with the following responsibilities in connection with the development and approval of clinical policies:

10. Coordinating research and development of clinical policies, which includes: a. Prioritizing all inquiries for new corporate policies and maintaining an electronic log of all requests for research and new policies with the requestor and subject of review.
    Highest priority is given to inquires based on open medical management cases such as pending authorizaitons or appeals cases. Response to these requests typically occurs within 24 hours. Priority then continues based on requests originating from providers or members, needs identified through financial analysis, followed by inquiries by vendors and technologies identified through trade publications.

11. Conducting prelimary review of topics as follows: a. A critical appraisal of the current published medical literature from peer-reviewed publications including systematic reviews, randomized controlled trials, cohort studies, case control studies, and diagnostic test studies with statistically sound methods.

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b. Evidence-based guidelines developed by national organizations and recognized authorities. c. Opinions and assessments by nationally recognized medical associations including physician specialty societies, consensus panels, or other nationally recognized research or technology assessment organizations such as Hayes, UpToDate, or ECRI.
d. Reports and publications of government agencies such as the Food and Drug, Administration (FDA), Centers for Disease Control (CDC), or National Institutes of Health (NIH).
e. External review organization recommendations.

3. Conveying the findings of the preliminary review to the requestor within the priority-based time frame. In cases of open medical management decisions, the requestor will use the information provided by the clinical policy staff and the specifics of the particular case to render a decision. Preliminary review findings are saved in an electronic file for future policy development.
4. For topics identified through medical management needs, if two requests for the same topic are submitted, a formal medical policy may be developed. Requests identified through financial analysis will follow this policy development process.
   a. The clinical policy staff utilizes the preliminary research to draft a policy. Relevant CPT, HCPCS and ICD-10 codes are identified and included in the policy. A review of historical handling and/or payment of the policy topic is also conducted to share with the CPC as appropriate. b. Opinions from external physicians are solicited as appropriate, including behavioral health physicians. The policy is sent for CPC review and approval.
   c. Subsequent to each new policy approval, the clinical policy staff sends a notice to all medical directors and medical management leadership to inform them of new policies that have been approved by the CPC.
   d. The completed policies are reviewed annually or updated more frequently as dictated by current medical literature, medical director or other relevant staff requests and appeals analysis.
   e. Completed policies are posted on CNET and in Adobe Experience Manager for access by internal staff and for plans to link to plan websites for providers.
5. Communication of these policies to provider networks is arranged by the plan marketing or provider network department.
6. Coordinating activities of the CPC including, but not limited to, the review, revision, approval, and maintenance processes of all

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corporate clinical policies. This includes scheduling meetings, sending necessary agendas and attachments, documenting meeting minutes, clinical policy reference number assignment, and the maintenance of such documents in electronic files and within the organizational internal database.

7. Generating reports reflecting CPC activity on a quarterly basis, or more frequently as needed, for the Committee Chair.
8. Notifying all relevant persons/departments and health plans regarding approved policies and related materials through email, including: a. Claim support service teams for dissemination to IS and claims.
   The clinical policy team offers direction/coordination for any system needs to support the clinical policy.
   b. Corporate Medical Management VPs and Corporate medical auditing and training teams for dissemination and auditing. c. CPC members, plan medical management VPs and directors, and other health plan contacts for dissemination to their plan UM personnel. This includes notification to plan representatives for inclusion in the plan UM or QI committee responsible for plan level policy approval. Marketing and/or

9. Facilitating training, as needed, with the corporate Medical Management Training Department. IV. Meeting Frequency A. CPC meetings are held, at minimum, on a quarterly basis. Frequency is dependent upon clinical policy revision cycles and/or clinical policy need (as determined by the CMO or designee). B. Meetings may be held in a physical location or through the use of alternative media as determined by the participation of members from remote locations or by the urgency of the clinical policy. Such media include video, telephonic conference call, or email.

   V. Committee Member Activities and Responsibilities: A. Identification of new subjects to consider for clinical policy development can occur in the following ways:

10. Through UM authorization requests;
11. New technologies identified through trade publications;
12. Inquiries from providers and vendors;
13. Review of appeals cases;
14. Suggestion of the Medical Policy Governance Team; B. Review of clinical policies which includes:
15. New clinical policy drafts;
16. Policies due for scheduled review;
17. Updates or revisions to existing policies outside of the scheduled review due to advances or changes in standards of care, new information, missing information or content error;

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4. Policy and prioritization requests for new clinical policies;

   MH/SUD Operations measure #2: Fidelis reviews the meeting minutes of the clinical policy committee on a quarterly basis and the UM sub committee on an as-needed basis (when BH Clinical Polices are reviewed) in order to ensure the processes and strategies used in applying the experimental/investigational criteria for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used in applying the experimental/investigational criteria, in operation, for medical surgical benefits.

   Outpatient: Same as inpatient.

   Emergency: N/A

   Prescription drug: Not applicable

   External Appeal Option When Fidelis receives an appeal for denial of a service for mental health or substance use disorder and medical or surgical benefits that is considered experimental or investigation, and the provider appealing provides literature to support the request, Fidelis can opt to utilize external review from Medical Review Institute of America (MRIoA), an Independent Clinical and Utilization Reviewer. The clinical information, clinical policy supporting the denial, and supporting evidence submitted by the provider is forwarded to MRIoA. A physician reviewer with the same or similar qualifications of the requesting provider is provided by MRIoA. MRIoA then provides its independent review and decision within 1-3 business day. The analyses, as documented, includes an assessment of each expert’s qualifications and the extent to which the plan or issuer ultimately relied upon each expert’s evaluations in setting recommendations regarding both mental health or substance use disorder and medical or surgical benefits. Fidelis then implements the decision by MRIoA, whether it is to uphold or overturn the appeal. These decisions are tracked to ensure there is no variation in the application of a guideline or standard used by the plan or issuer between mental health or substance use disorder and medical or surgical benefits

   Step 6: Summary conclusion of how plan or issuer has determined overall compliance.

   Inpatient: As written and in operation, the processes, strategies, evidentiary standards, and factors used to design and apply the experimental/investigational determinations criteria for MH/SUD benefits are comparable to and applied no more stringently than the processes, strategies, evidentiary standards, and factors used to design and apply the experimental/investigational determinations criteria for medical/surgical benefits in each classification of benefits.

   As Written Analysis
   As demonstrated in detailed analysis in Step 4, the evidentiary standards and processes used to

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develop experimental/investigational determinations criteria for MH/SUD and M/S services in writing are comparable and no more stringent.

In addition, only appropriate practitioners can make the decision to deny coverage of a requested service based on medical necessity guidelines and experimental/investigational determinations criteria. Practitioner types appropriate for making the following types of denial decisions are comparable and no more stringent for MH/SUD and M/S services. Therefore, Fidelis’ processes and strategies used to design the experimental/ investigational determinations criteria, as written, for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used to design the experimental/investigational determinations criteria as written, for medical/surgical benefits.

In Operation Analysis
In addition, the operations measures outlined in Step 5 are comparable for MH/SUD and M/S services. For instance, both MH/SUD and M/S services have two operations measures which include: (1) a committee based process for regular review of medical necessity policies and clinical coverage guidelines, (2) periodic review of committee meeting minutes to ensure that processes for review of M/S and MH/SUD clinical criteria are comparable and no more stringent.

The only difference is in operations measure #1, because the committees responsible for review and adoption of the medical necessity criteria (and experimental/investigational determinations criteria) are different for behavioral health versus physical health services. For MH/SUD services, there is quarterly Behavioral Health Clinical Policy Committee that reviews new policies and updates and makes recommendations to the Utilization Management Sub-Committee (UMSC). For M/S services, there is a monthly clinical policy committee which reviews new policies and updates and makes recommendations to the UMSC.

However, the process for establishing and updating experimental/investigational determinations criteria (which are updated through the same process as medical necessity criteria) are the same for both M/S and MH/SUD services in operation. Clinical and preventative guidelines are reviewed and updated at least every two years and more frequently when updates are released by the issuing entity. Fidelis Care’s Utilization Management Sub-Committee (UMSC) reviews adopted guidelines for appropriateness and applicability to our member and provider network. The Clinical and Preventative Guidelines Report is brought to UMSC at least every two years for review. The report includes: adopted guidelines, medical source of the guideline, provider type the guideline targets and the status of guidelines (changed/unchanged). The report also includes measures for monitoring provider adherence to the adopted guidelines.

Therefore, as demonstrated in Step 4, the processes, strategies, evidentiary standards, and factors used to design the experimental/investigational determinations criteria for MH/SUD benefits are comparable to and applied no more stringently than the processes, strategies, evidentiary standards, and factors used to design the experimental/ investigational determinations criteria for

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M/S services. Furthermore, as demonstrated by the operations measures in Step 5, the processes, strategies, evidentiary standards, and factors used to apply the experimental/investigational determinations criteria in operation for MH/SUD benefits are comparable to and applied no more stringently than the processes, strategies, evidentiary standards, and factors used to apply the experimental/ investigational determinations criteria in operation for M/S services.

Outpatient: Same as inpatient.

Office visit: Same as inpatient.

Outpatient other: Same as inpatient.

Emergency: N/A

Prescription drug: Not applicable

Reviews, Revisions, and Approvals Date Approval Date Changed wording for Pharmacy from Same as inpatient to not applicable throughout the document. In Step 5, the Utilization Management Subcommittee is described. Members of the UM Subcommittee and Fidelis Clinical Policy Committee are added as an attachment. 5/22

Annual Review. Updated UMSC and CPC List1/23 1/23

Annual Review. Deleted pharmacy sections, as this is now performed at Corporate. Updated specialties; Updated UMSC and CPC members list 1/24

Annual Review. Added in the policy statement that the policy applies to health plans affiliated with Centene Advanced Behavioral Health as well. Updated medical directors specialties. Changed UMSC meeting as occurring “quarterly” instead of “monthly”. Updated UMSC and CPC members list. 1/25

Annual Review. Removed “ by the 15th of the month” from statement of policy submission to Communication for publication. Updated UMSC and CPC members list. 1/26

References

1. Centene Clinical Policy CP.CPC.01 Clinical Policy Committee
2. Centene Clinical Policy CP.MP.36 Experimental Technologies
3. Fidelis Clinical Policy CP.FC.45 Non-Quantitative Treatment Limitation Parity
   Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 4.Attachment A-Members of the Utilization Management Subcommittee and Members of the Fidelis Clinical Policy Committee

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CPC committee list 2025-6.docx