CurrentmediviewcurativePolicy 02

Experimental, Investigational and Emerging Technology

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Defines how Curative determines and manages services considered experimental or investigational for medical and pharmacy utilization management; applies to the Medical and Pharmacy UM Departments and delegated entities.

Policy Summary

Payermediviewcurative

PolicyExperimental, Investigational and Emerging Technology

Policy CodePolicy 02

Change TypeNo material change

Effective DateMar 22, 2024

Next Review Date

Key ActionSubmit prior authorization documentation demonstrating that the service meets written, objective, measurable UM criteria to avoid denial as experimental/investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Criteria-basedCriteria-based

Applies to UMApplies to UM

Non-coveredNon-covered services

TrainingEmployee training required

Experimental / Investigational Determination & Coverage

Policy Summary

Payermediviewcurative

PolicyExperimental, Investigational and Emerging Technology

Policy CodePolicy 02

Change TypeNo material change

Effective DateMar 22, 2024

Next Review Date

Key ActionSubmit prior authorization documentation demonstrating that the service meets written, objective, measurable UM criteria to avoid denial as experimental/investigational.

SourceLink

On This Page

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CurrentmediviewcurativePolicy 02

Experimental, Investigational and Emerging Technology

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Sign up for mediviewcurative Policy 02 alerts

Get alerted when Policy 02 changes without checking for updates manually.

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Policy Summary

Payermediviewcurative

PolicyExperimental, Investigational and Emerging Technology

Policy CodePolicy 02

Change TypeNo material change

Effective DateMar 22, 2024

Next Review Date

Key ActionSubmit prior authorization documentation demonstrating that the service meets written, objective, measurable UM criteria to avoid denial as experimental/investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Criteria-basedCriteria-based

Applies to UMApplies to UM

Non-coveredNon-covered services

TrainingEmployee training required

Experimental / Investigational Determination & Coverage

Policy Summary

Payermediviewcurative

PolicyExperimental, Investigational and Emerging Technology

Policy CodePolicy 02

Change TypeNo material change

Effective DateMar 22, 2024

Next Review Date

Key ActionSubmit prior authorization documentation demonstrating that the service meets written, objective, measurable UM criteria to avoid denial as experimental/investigational.

SourceLink

On This Page

Experimental/Investigational Determination

Services meeting ANY of the following criteria are considered experimental/investigational:

Experimental/Investigational Criteria: The intervention does not have Food and Drug Administration (FDA) approval to be marketed for the specific relevant indication(s).any criterion met

If true, the service is considered experimental/investigational and non-covered.

Experimental/Investigational Criteria: Available scientific evidence does not permit conclusions concerning the effect of the intervention on health outcomes.any criterion met

Lack of conclusive evidence supports investigational determination.

Experimental/Investigational Criteria: The intervention is not proven to be as safe or effective in achieving an outcome equal to or exceeding the outcome of alternative therapies.any criterion met

Comparative effectiveness against established alternatives is required for coverage.

Experimental/Investigational Criteria: The intervention does not improve health outcomes.any criterion met

No demonstrated improvement in health outcomes supports non-coverage.

Experimental/Investigational Criteria: The intervention is not proven to be applicable outside the research setting.any criterion met

Interventions limited to research contexts are considered investigational and non-covered.

Decision Basis: Utilization Management decisions are made using written, objective, measurable criteria based on sound clinical evidence and in accordance with currently accepted medical or health care practices; special circumstances may warrant deviations as appropriate.all applicable evidence considerations applied

Statement of UM decision-making approach per policy.

This policy addresses services determined to be experimental/investigational and therefore non-covered. It guides Medically Necessary utilization decisions for requests deemed experimental or investigational and establishes that Utilization Management decisions rely on written, objective, measurable criteria based on sound clinical evidence and currently accepted medical practice.

Services that meet any of the listed experimental/investigational criteria are considered non-covered and not medically necessary. Curative will apply its written UM decision criteria to such requests and may deny coverage when the intervention fails to satisfy the policy’s evidence- and approval-based requirements.

Utilization Management, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior authorization and UM review use written, objective, measurable criteria

Curative uses written utilization review decision criteria that are objective, measurable, and based on sound clinical evidence when making prior authorization and UM determinations for services that may be experimental or investigational; such services are treated as non‑covered for medical necessity decisions.

Step Therapy

UM decisions consider benefit relative to established alternatives (step‑therapy linkage)

UM decisions explicitly consider whether an intervention is as beneficial as established alternatives and whether alternatives exist; step‑therapy logic should account for established alternatives when evaluating investigational status.

Decision criteria include whether the intervention is proven as safe or effective compared with alternative therapies.

Denial Risk

Non‑coverage/denial risk when intervention lacks approval or evidence

Requests for services meeting the policy's experimental/investigational criteria will be considered non‑covered and may be denied when the intervention lacks FDA approval for the specific indication, lacks adequate scientific evidence on health outcomes, is not proven as safe or effective compared with alternatives, does not improve health outcomes, or is not applicable outside research.

Examples of criteria leading to noncoverage include lack of FDA approval for the specific indication and insufficient scientific evidence on health outcomes.

Documentation Required

Documentation: submit required evidence and regulatory documentation

Provide the documentation specified to satisfy this policy or any applicable legal or regulatory requirements; the policy instructs to supply details regarding required documentation but does not list state‑specific or other document types within the policy text.

Policy states: 'Provide details regarding any specific documentation required for this policy or to meet any legal or regulatory requirements related to this policy.'
If state or regulatory requirements apply, submit the documentation necessary to demonstrate compliance as part of the authorization request.

Policy Background and Rationale

For the purposes of this policy, experimental/investigational describes interventions that meet any of the following: lack of FDA approval for the specific indication; insufficient scientific evidence to permit conclusions about effects on health outcomes; not proven to be as safe or effective as alternative therapies; do not improve health outcomes; or are not proven applicable outside the research setting. The Medical Policy Committee and UM staff use these criteria, together with objective, measurable, evidence-based decision rules, to determine coverage.

Key Definitions

Experimental/Investigational services

DefinitionA treatment, procedure, facility, equipment, drug, service, or supply determined not to be medically effective for the condition being treated.

Coverage implicationServices meeting the definition are considered experimental/investigational and are treated as non-covered under this policy.

Decision authorityThe Medical Policy Committee may consider specialty society recommendations and other relevant factors when determining status.

Investigational

DefinitionServices that do not meet the Company Technology Evaluation Criteria.

Criteria: Regulatory approvalDoes not have final approval from the appropriate government regulatory body.

Criteria: EvidenceLacks credible scientific evidence in peer-reviewed medical literature permitting reasonable conclusions about effects on health outcomes.

Criteria: Clinical benefitNot proven to materially improve net health outcome or to be as beneficial as established alternatives.

Criteria: ApplicabilityNot shown to improve outcomes outside the investigational/research setting.

Authority noteMPC may also consider recommendations from specialty societies, professional organizations, public health agencies, and other relevant factors in its discretion.