CurrentCentenePolicy CP.MP.36

Experimental Technologies (PDF)

Defines Centene-affiliated health plans' framework for evaluating coverage of technologies (drugs, procedures, devices, services, supplies) considered experimental or investigational when no other policy applies; requires case-by-case review against specified criteria and Benefit Plan Contract/state/federal requirements.

Policy Summary

PayerCentene

PolicyExperimental Technologies (PDF)

Policy CodePolicy CP.MP.36

Change TypeRevisions and annual clarifications

Effective Date

Next Review Date

Key ActionProviders should submit at least two peer-reviewed studies, regulatory approval status, expert opinions, risk/benefit discussion, evidence alternatives have been exhausted, and informed consent to support medical necessity determinations.

SourceLink

POLICY UPDATE CHANGES

Policy reorganized to require both criteria A and B and restructured medical necessity under I.B.1–10; added B.8–B.10 and note about severity.

Clarified I.A.2 wording and added example of Hayes as an evaluation body.

Removed duplicative statements regarding clinical trials and updated references and formatting.

10Medical necessity subcriteria

2Required peer-reviewed studies

1Policy reference number

Medical Necessity Criteria

General Policy Statement

Coverage determinations for technologies that are or may be experimental/investigational must be considered case-by-case and meet BOTH A and B below:

I.A - When a technology is considered experimental or investigational

It is currently the subject of active and credible evaluation (e.g., clinical trials or research) to determine clinical efficacy, therapeutic value or beneficial effects on health outcomes, or benefits beyond any established medically based alternatives.
The most recent peer-reviewed scientific studies published or accepted for publication by nationally recognized medical journals do not conclude, or are inconclusive in findings, that the service is safe and effective for the treatment of the condition for which authorization of the service is requested.

I.B - Medical necessity evaluation (ALL of the following must be considered)

The technology should have final approval from appropriate governmental regulatory bodies when applicable (FDA or other authority). The indication under review does not need to be the same as the approved indication.
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.2 studies
Studies must be well-designed and well-conducted, yield quality and consistent results, and demonstrate effect on the disease/condition.
Opinions/evaluations of national medical associations, consensus panels, and other technology evaluation bodies (e.g., Hayes) or subject matter experts may be considered according to the scientific quality of supporting evidence and rationale.
The health benefits of the technology must outweigh any harmful effects or risks to the member/enrollee.
Other established treatment alternatives should have been exhausted and failed or no established treatment exists.
The improvement expected by employing the technology should be attainable outside the control setting (i.e., in practice).
For diagnostic procedures, it is anticipated that the results will help determine the best plan of care and there must be potential intervention or alteration to the current plan of care based on results.
The member/enrollee fully understands the risks and benefits regarding the requested technology or treatment and has given informed consent.
Technology is consistent with the symptoms or diagnosis of the illness or injury under treatment.
Technology is not furnished primarily for the convenience of the patient, provider or supplier.
Technology is furnished at the most appropriate level of care that can be provided safely and effectively to the patient.
Severity of the member/enrollee's condition will be considered when evaluating the request.
Severity may affect evaluation but does not override Benefit Plan Contract or regulatory requirements.

Provider Actions & Requirements

Documentation Required

Case-by-case physician or committee review required

Coverage determinations must be made on a case-by-case basis by a physician or ad hoc committee and in accordance with the Benefit Plan Contract and applicable state and federal requirements.

Documentation Required

Evidence submission required

Providers should submit peer-reviewed studies (minimum two), regulatory approval status, expert opinions, risk/benefit discussion, evidence that alternatives have been exhausted, and documentation of informed consent to support medical necessity determination.

Peer-reviewed studies (minimum two)
Regulatory approval status
Expert opinions/evaluations
Risk/benefit discussion
Evidence that other established alternatives have been exhausted
Documentation of informed consent

Documentation Required

Informed consent required

Member/enrollee must have given informed consent documenting understanding of risks and benefits.

Billing Rule

Apply Benefit Plan Contract and state/federal provisions

Plan may refuse coverage if Benefit Plan Contract or state/federal requirements do not require coverage. State Medicaid provisions take precedence for Medicaid members; applicable NCDs/LCDs must be reviewed for Medicare members.

State Medicaid coverage provisions take precedence for Medicaid members
Review applicable Medicare NCDs/LCDs and Medicare Coverage Articles for Medicare members

Denial Risk

Denial possible if criteria not met

Claims may be denied if technology lacks sufficient peer-reviewed evidence, favorable risk/benefit profile, regulatory approval when applicable, or if furnished primarily for convenience or outside appropriate level of care.

Insufficient or inconclusive peer-reviewed evidence
Unfavorable risk versus benefit
Lack of regulatory approval when applicable
Furnished primarily for convenience of patient, provider, or supplier
Provided at an inappropriate level of care

Effective Date	Name	Number	Type
2015-10-01	Category III codes reference	L35490	NCD

Background

This policy provides a framework to evaluate the medical necessity of technologies that are or may be experimental or investigational and specifies criteria to be applied when no other policy exists.

It emphasizes that determinations must be consistent with the Benefit Plan Contract and applicable state and federal regulatory requirements, and notes that when medical necessity is confirmed, the technology should be furnished by a participating or in-state provider to the extent possible.

Definitions

TechnologyDrugs, procedures, devices, services, or supplies that may be considered experimental or investigational.

Experimental or investigationalSubject to active credible evaluation or lacking conclusive peer-reviewed evidence of safety/effectiveness for the requested indication.

Evidence Requirements

Evidence requirements include the availability of at least two studies published in peer-reviewed medical literature that support conclusions about the technology's effect and likely net health impact.

Such studies must be well-designed and well-conducted, yield quality and consistent results, and demonstrate the effect on the disease/condition; study quality and consistency are explicitly noted as important in the I.B subcriteria.

Evidence requirements

Required peer-reviewed studiesAt least two supportive studies

Revision History

02/23Material

Policy reorganized to require both criteria A and B and restructured medical necessity under I.B.1–10; added B.8–B.10 and note about severity.

03/24Administrative/Clarifying

Noted in the policy statement I. that the policy applies to health plans affiliated with Centene Advanced Behavioral Health as well.

08/25Administrative/Clarifying

Removed 'Centene Advanced Behavioral Health' from policy statement in I.

01/25Administrative/Clarifying

Annual review with minor grammatical changes to Criteria I.A.2 and I.B.1; added example of Hayes as an evaluation body in Note after I.B.2.

01/26Administrative/ClarifyingLatest

Annual review: Under I.A. replaced 'it meets any of the following criteria' with 'any of the following apply'; references reviewed and updated. (Last review date used where explicit change date not provided.)

OpenPayer

Experimental Technologies (PDF)

Coverage Summary

Medical Necessity Criteria

Provider Actions & Requirements

Coding and Medicare Determinations

Background

Evidence Requirements

Revision History