CurrentHealth NetPolicy CP MP.36

Clinical Policy: Experimental Technologies

Defines general guidelines for evaluating whether medical and behavioral health technologies (drugs, procedures, devices, services, supplies) are experimental or investigational and when they may be considered for coverage; to be used when no other specific policy exists and subject to Benefit Plan Contract and state/federal requirements.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Experimental Technologies

Policy CodePolicy CP MP.36

Change TypeClarified; administrative updates

Effective DateJun 1, 2009

Next Review DateN/A

Key ActionConsider coverage determinations for experimental/investigational technologies on a case-by-case basis and document evidence, regulatory status, peer-reviewed studies, and informed consent.

POLICY UPDATE CHANGES

Policy statement updated to require both A (technology characteristics) and B (medical necessity) criteria.

Noted applicability to health plans affiliated with Centene Advanced Behavioral Health (03/24) and later removed (08/25).

Annual reviews with minor grammatical and background updates recorded through 01/25 and 08/25.

10Medical necessity subcriteria

>=2Preferred number of peer-reviewed studies

Case-by-caseCoverage determination method

Coverage Summary

Overview: CP MP.36 (Experimental or Investigational Technologies) provides general guidelines for evaluating whether medical and behavioral health technologies (drugs, procedures, devices, services, supplies) are experimental or investigational. Status: CURRENT. Policy effective date: 2009-06-01. Last review/last revision date: 2025-08-01. Policy number: CP MP.36. Subject: Experimental or Investigational Technologies.

Coverage stance and intended use: Coverage stance is mixed. This policy is intended to be used when no other specific policy exists and determinations are made case-by-case subject to the member's Benefit Plan Contract and applicable state/federal requirements.

Policy numberCP MP.36

PayerHealth Net

Policy titleClinical Policy: Experimental Technologies

Effective date2009-06-01

Last review2025-08-01

Coverage stancemixed

Definition: Experimental or Investigational

Definition: When a technology is considered experimental or investigational

A technology is requested and is considered experimental or investigational if it meets ANY of the following criteria:

ANY of the following

It is the subject of active and credible evaluation (e.g., clinical trials or research) to determine therapeutic value, clinical efficacy, and benefits beyond established alternatives.
The most recent peer-reviewed scientific studies published or accepted for publication in nationally recognized medical journals do not conclude, or are inconclusive that the service is safe and effective for the requested condition.
The technology does not have final approval from appropriate governmental regulatory bodies when applicable (e.g., FDA) for marketing; the indication need not match the approved indication.
Fewer than two studies published in peer‑reviewed medical literature are available to support conclusions regarding the effect of the technology and likely net health impact.

Medical Necessity Evaluation (when technology is under consideration)

Medical Necessity Evaluation (applies when technology is under consideration)

The requested technology must meet BOTH of the following A and B. B (Medical necessity) is evaluated on a case-by-case basis considering ALL of the following:

A. Technology characteristics

It is currently the subject of active and credible evaluation (e.g., clinical trials or research) to determine therapeutic value, clinical efficacy, and benefits beyond established medical alternatives.
Final approval from appropriate governmental regulatory bodies is absent when applicable.

B. Medical necessity considerations (all must be considered)

The most recent peer-reviewed scientific studies do not conclude, or are inconclusive, that the service is safe and effective for the requested condition.
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 must be well-designed and well-conducted yielding quality and consistent results.
The health benefits of the technology must outweigh any harmful effects or risks to the member/enrollee.
Improvement from the technology should be attainable outside the controlled setting (i.e., in practice).
Other established treatment alternatives should have been exhausted and failed, or no established treatment exists.
For diagnostic procedures: results are anticipated to help determine the best plan of care and there must be potential intervention or alteration to current plan of care based on results.
Technology must be consistent with the symptoms or diagnosis of the illness or injury under treatment.
Member/enrollee understands risks and benefits and has given informed consent.
Technology is not furnished primarily for convenience of the patient, provider, or supplier.
Technology is furnished at the most appropriate level of care that can be provided safely and effectively; severity of condition will be considered.

Provider Actions

Prior Authorization

Prior authorization required per Benefit Plan

Requests for technologies that may be experimental/investigational require authorization and review against this policy and the member's Benefit Plan Contract; review the Benefit Plan to confirm coverage requirements before proceeding.

Review request against the member's Benefit Plan Contract and this policy

Documentation Required

Case-by-case medical necessity evaluation

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

Document supporting evidence (peer‑reviewed studies)
Document regulatory status (e.g., FDA approval or lack thereof)
Document relevant peer‑reviewed studies
Document that informed consent was obtained

Denial Risk

Denial possible if not in Benefit Plan

The plan may refuse coverage if the technology is not required under the member/enrollee's benefit plan or is contrary to state Medicaid provisions; state Medicaid provisions take precedence when there is a conflict.

State Medicaid coverage provisions supersede this policy when conflicting

Documentation Required

Evidence requirements

Provide supporting materials to substantiate safety and effectiveness, including peer-reviewed studies, expert evaluations, and documentation of risk/benefit discussion and informed consent.

Preferably ≥2 peer‑reviewed studies of adequate design and quality
Evaluations/opinions from national medical associations, consensus panels, or technology evaluation bodies (e.g., Hayes)
Documentation of informed consent and risk/benefit discussion

Coding

Coding / billing: This policy lists no specific billing or code groups. Providers should follow the member's Benefit Plan and prior authorization guidance and use standard billing/coding practices applicable to the service requested.

Related determinations: For Medicare policy alignment, see the referenced Local Coverage Determination for Category III codes (LCD L35490), and review all applicable NCDs and LCDs when applicable.

Type	Name	Number	Effective Date
LCD	Local coverage determination: Category III codes	L35490	2015-10-01

Background

Background: The criteria in this policy should be weighed when evaluating the medical necessity of a technology that is or may be experimental or investigational. The policy sets out both technology characteristics and medical necessity considerations to be evaluated on a case-by-case basis.

When medical necessity is confirmed under this policy, steps should be taken to furnish the technology by a participating or in‑state provider to the extent possible. Under no circumstances does this policy itself create an obligation to cover technologies that are not included in the Benefit Plan Contract or required by applicable state or federal requirements; the Plan may refuse coverage if the technology is not required under the member/enrollee's benefit plan.

Definitions

Scope

Revision History

02/23material_change

Criteria restructured; added B.8-B.10 and note regarding severity of condition; references reviewed and updated. Policy statement updated to require both A and B criteria.

03/24administrative

Administrative affiliation note added indicating applicability to health plans affiliated with Centene Advanced Behavioral Health.

01/25administrative

Annual administrative update: minor grammatical/background changes, references reviewed and updated.

08/25administrative

Administrative affiliation note removed (Centene Advanced Behavioral Health removed from policy statement); annual administrative updates recorded.

2025-08-01reviewLatest

Last review date recorded.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Experimental Technologies

Policy CodePolicy CP MP.36

Change TypeClarified; administrative updates

Effective DateJun 1, 2009

Next Review DateN/A

Key ActionConsider coverage determinations for experimental/investigational technologies on a case-by-case basis and document evidence, regulatory status, peer-reviewed studies, and informed consent.

On This Page

OpenPayer

Clinical Policy: Experimental Technologies

Coverage Summary

Definition: Experimental or Investigational

Medical Necessity Evaluation (when technology is under consideration)

Provider Actions

Coding

Medicare Determinations

Background

Revision History