Priority Health experimental/investigational policy Prior Auth

Coverage Criteria and Exceptions

General Exclusion Criteria

Not covered when ANY of the following are true:

Experimental/Investigational/Unproven definition: A drug, device, treatment, or procedure is experimental, investigational or unproven if any of these apply: the drug or device has not received final FDA marketing approval or clearance; it is provided pursuant to oversight by an Institutional Review Board (IRB) or similar research review body; the patient informed consent documents describe the service as experimental or investigational; reliable evidence shows it is the subject of ongoing Phase I or II clinical trials or the investigational arm of Phase III trials; prevailing expert opinion is that further studies or trials are required; or it is not widely used or generally accepted as standard medical care in nationally recognized peer-reviewed English-language literature.

Source lists six specific criteria.

Individual Case Review / Benefit Exception Criteria

Coverage exception (individual case review) may be considered when ALL the following apply:

Exception review eligibility: The member has a terminal illness or a chronic, life‑threatening, severely disabling disease causing serious clinical deterioration; all accepted standard treatments and technologies have been considered or used; the requested treatment is under the auspices of a nationally recognized sponsor and, where required, subject to IRB oversight; informed consent is documented; care will be provided at a participating or in‑network facility; an independent expert physician review panel may be consulted.

Prior Plan approval is required; determinations made by a Priority Health medical director or clinical pharmacist.

Clinical Trial and IDE Coverage Rules

Clinical trial and investigational device cost coverage rules:

Routine patient care in clinical trials: Routine patient care costs — i.e., items and services typically covered when provided outside a clinical trial — are covered when provided within a clinical trial or experimental care setting; coverage includes clinically appropriate monitoring, prevention of complications, and medically necessary services to administer investigational items. Costs specifically generated by the clinical trial (including the investigational agent/device itself) are not covered.

Refer to Clinical Trials Medical Policy #91606 for additional details.

IDE device categorization: For investigational device exemptions (IDEs): Category A IDEs and associated care are not covered; Category B IDEs used in a clinical trial may have routine patient care costs covered if prior authorized, but the investigational device itself is not a covered benefit. HUD/HDE devices are considered experimental and excluded unless listed as covered in the HUD/HDE reference sheet.

Prior authorization required for Category B IDEs and individual case review determinations.

Not Medically Necessary / Experimental

Listed services are classified as experimental/investigational/unproven and are generally not covered.

General exclusion: Services billed with codes enumerated in this 'Experimental/Investigational/Unproven Care/Benefit Exceptions' list are considered not covered under this policy section.

The list is not inclusive; some entries include inline notes (e.g., 'Covered for Medicare/Medicaid').

Experimental/Investigational / Unproven Care

The following assays and associated CPT/PLA codes are categorized as Experimental/Investigational/Unproven:

List: All individual assay entries (examples include CPT/PLA codes 0344U through 0609U and the specific tests described in the coding section such as biochemical panels, proteomic/algorithmic assays, and novel biomarker panels) are treated as experimental, investigational, or unproven per this policy and are generally not covered.

See coding module for the complete enumerated list of assay codes and descriptions.

Care received outside the United States is not covered under this policy. In addition, any drug, device, treatment, or procedure that the plan determines to be experimental, investigational, or unproven is generally not a covered benefit. Examples of items excluded as experimental/investigational include non‑FDA approved drugs or devices, unapproved medical procedures, diagnostic tests performed solely for investigational purposes, and services generated specifically by a clinical trial that are not routine patient care. Routine patient care costs associated with a clinical trial may be covered when they meet the definition of routine care, but care delivered outside the U.S. and items meeting the policy definition of experimental/investigational/unproven remain excluded.

Some procedure and laboratory codes in the enumeration are noted as exceptions for specific public programs. Where a code line explicitly states “Covered for Medicare” or “Covered for Medicare & Medicaid”, those program‑specific coverage notations are shown inline with the code list. Absent such a notation, codes listed in the Experimental/Investigational/Unproven Care section are treated as not covered. Providers should follow the code list entries and any inline annotations when determining coverage for Medicare or Medicaid members.

Devices granted a Humanitarian Device Exemption (HDE) or designated as Humanitarian Use Devices (HUDs) are considered experimental and investigational and are excluded from coverage unless specifically listed as covered. The policy includes a HUD/HDE reference sheet identifying HUDs/HDEs that may be covered when used in accordance with their FDA approval and when referenced supporting medical policy indicates coverage; otherwise HUD/HDEs remain excluded.

Non‑FDA approved drugs or devices, unapproved medical procedures, and diagnostic tests performed solely for investigational purposes are not considered routine patient care and are not covered. The policy treats such items as experimental/investigational/unproven and excludes them from coverage unless a specific exception (for example, an explicitly listed code with a Medicare/Medicaid coverage note or an approved HUD/HDE entry) is documented in the policy.

Codes and services grouped under the heading Experimental/Investigational/Unproven Care/Benefit Exceptions are classified together for coverage determination. Entries in this section are considered not medically necessary and not covered unless a specific in‑line exception is noted. The list is not inclusive and serves to identify items the plan has determined lack sufficient evidence of clinical benefit for routine coverage.

Use of the assays and proprietary CPT/PLA codes enumerated in the policy (for example, entries in the 0344U–0609U range and related assay descriptions) is considered not medically necessary, experimental, investigational, or unproven and may be denied as not covered. The policy lists these assays and associated codes specifically to indicate they are subject to this classification and potential denial.

Experimental/Investigational/Unproven Care/Benefit Exceptions — Definition

DefinitionServices, procedures, devices, or tests that the payer determines lack sufficient evidence of clinical benefit and therefore are generally excluded from coverage.

Evidence triggersConsidered experimental/investigational/unproven when: no FDA final marketing approval/clearance; provided under IRB or research oversight; described as experimental in informed consent; subject of ongoing Phase I or II trials or investigational arm of Phase III; prevailing expert opinion requires further study; not widely used or accepted in peer-reviewed literature.

Coverage implicationItems meeting this definition are not covered benefits and may be denied when billed with listed experimental/unproven codes.

Coding — Listed Codes and Status

General not covered / Example CPT/HCPCS codesCPTNot Covered

20560	Needle insertion(s) without injection(s); 1 or 2 muscle(s).
20561	Needle insertion(s) without injection(s); 3 or more muscles.
34839	Physician planning of a patient-specific fenestrated visceral aortic endograft requiring a minimum of 90 minutes of physician time.
43206	Esophagoscopy, rigid or flexible; with optical endomicroscopy.
43252	Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with optical endomicroscopy.
52284	Cystourethroscopy, with mechanical urethral dilation and urethral therapeutic drug delivery by drug-coated balloon catheter for urethral stricture or stenosis, male, including fluoroscopy, when performed.
53451	Periurethral transperineal adjustable balloon continence device; bilateral insertion, including cystourethroscopy and imaging guidance.
53452	Periurethral transperineal adjustable balloon continence device; unilateral insertion, including cystourethroscopy and imaging guidance.
53453	Periurethral transperineal adjustable balloon continence device; removal, each balloon.
53454	Periurethral transperineal adjustable balloon continence device; percutaneous adjustment of balloon(s) fluid volume.

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Experimental CPT/HCPCS (sample from chunk 19)mixedNot Covered

20560	Needle insertion(s) without injection(s); 1 or 2 muscle(s)
20561	Needle insertion(s) without injection(s); 3 or more muscles
34839	Physician planning of a patient-specific fenestrated visceral aortic endograft requiring a minimum of 90 minutes of physician time
43206	Esophagoscopy, rigid or flexible; with optical endomicroscopy
43252	Upper gastrointestinal endoscopy; with optical endomicroscopy
52284	Cystourethroscopy with mechanical urethral dilation and urethral therapeutic drug delivery by drug-coated balloon catheter for urethral stricture or stenosis
53451	Periurethral transperineal adjustable balloon continence device; bilateral insertion
53452	Periurethral transperineal adjustable balloon continence device; unilateral insertion
53453	Periurethral transperineal adjustable balloon continence device; removal, each balloon
53454	Periurethral transperineal adjustable balloon continence device; percutaneous adjustment of balloon(s) fluid volume

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Experimental CPT/HCPCS (sample from chunk 20)mixedNot Covered

84393	Tau, phosphorylated (eg, pTau 181, pTau 217), each (Covered for Medicare & Medicaid)
84394	Tau, total (tTau) (Covered for Medicare & Medicaid)
84431	Thromboxane metabolite(s), including thromboxane if performed, urine
86305	Human epididymis protein 4 (HE4)
86352	Cellular function assay involving stimulation and detection of biomarker (e.g., ATP)
87513	H. pylori clarithromycin resistance, amplified probe technique (Covered for Medicare & Medicaid)
88130	Sex chromatin identification; Barr bodies
90865	Narcosynthesis for psychiatric diagnostic and therapeutic purposes

Extensive list of experimental/unproven codes (chunks 21-37)mixedNot Covered

91117	Colon motility (manometric) study, minimum 6 hours continuous recording
92145	Corneal hysteresis determination, by air impulse stimulation
93740	Temperature gradient studies
93895	Quantitative carotid intima media thickness and carotid atheroma evaluation, bilateral
96020	Neurofunctional testing selection and administration during noninvasive imaging functional brain mapping
96931	Reflectance confocal microscopy (RCM) for skin; acquisition and interpretation, first lesion
96932	Reflectance confocal microscopy (RCM) for skin; acquisition only, first lesion
96933	Reflectance confocal microscopy (RCM) for skin; interpretation and report only, first lesion
96934	Reflectance confocal microscopy (RCM) for skin; image acquisition and interpretation and report, each additional lesion
96935	Reflectance confocal microscopy (RCM) for skin; image acquisition only, each additional lesion

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Experimental / Investigational CPT Category I/PLA codes listedCPTNot Covered

0344U	Hepatology (NAFLD), semiquantitative evaluation of 28 lipid markers by LC-MS/MS, serum
0351U	Infectious disease, assays for TRAIL, IP-10, and CRP, serum or whole blood
0358U	Neurology (MCI), analysis of B-amyloid 1-42 and 1-40, CSF
0360U	Oncology (lung), ELISA of 7 autoantibodies, plasma (Covered for Medicare only)
0365U	Oncology (bladder), analysis of 10 protein biomarkers in urine
0367U	Oncology (bladder), 10 protein biomarkers in urine for recurrence risk
0385U	Nephrology (CKD), ApoA4, CD5L, IGFBP3 by ELISA, plasma with algorithm
0387U	Oncology (melanoma), AMBRA1 and loricrin by IHC, FFPE
0390U	Obstetrics (preeclampsia), KDR, ENG, and RBP4 by immunoassay, serum
0393U	Neurology, detection of misfolded α-synuclein in CSF by seed amplification assay

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Colon motility recording duration

Minimum recording durationColon motility (manometric) study requires a minimum of 6 hours continuous recording (including provocation tests if performed).

IncludesRecording may include provocation tests such as meal, intracolonic balloon distension, or pharmacologic agents when performed.

ReportingStudy must include interpretation and report as part of the procedure code (91117).

sFlt1/PlGF risk window

Risk windowsFlt-1/PlGF assay (sFlt1/PlGF ratio) reports risk of progression for preeclampsia with severe features within 2 weeks.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required for Exceptions

Prior authorization is required for individual case review of investigational care and for Category B IDE devices under certain conditions. Requests for individual consideration require prior Plan approval and all determinations will be made by a Priority Health medical director or clinical pharmacist.

Individual case review requires prior Plan approval.
Category B IDEs used in a clinical trial require prior authorization; routine patient care costs may be covered but the device itself is not a covered benefit.

Denial Risk

Prior Authorization Not Granting Coverage for Listed Experimental Codes

Codes listed in the Experimental/Investigational/Unproven Care/Benefit Exceptions list are identified as not covered. Prior authorization for these codes is not a guarantee of coverage; services billed with these codes are subject to denial under the plan.

Background and Scope

This policy defines investigational/experimental items as interventions that are undergoing preclinical or clinical evaluation or that lack regulatory support and sufficient evidence of clinical benefit. It summarizes the scope and applicability: the exclusions apply to drugs, devices, procedures, and diagnostic tests that meet the policy definition, and the policy also describes how routine patient care costs in clinical trials are handled (routine care may be covered while investigational agents, devices, or trial‑specific costs are not). Determinations about exceptions and routine cost coverage are made according to the policy language and supporting program‑specific notes.

Definitions

Humanitarian Use Device (HUD) / Humanitarian Device Exemption (HDE)

HUD definitionA Humanitarian Use Device (HUD) is intended to benefit patients with conditions affecting 8,000 or fewer individuals per year in the U.S.

HDE authorizationA Humanitarian Device Exemption (HDE) authorizes marketing of a HUD without requiring demonstration of effectiveness typical for PMA, but requires probable benefit and other restrictions.

Coverage noteHUDs/HDEs are generally considered experimental/investigational and excluded from coverage unless specifically listed as covered in the HUD/HDE reference sheet.

Promising

Promising — definitionPreliminary scientific data supports a reasonable likelihood of success of the treatment for the diagnosis.

Evidence level

OpenPayer

Experimental/Investigational/Unproven Care / Benefit Exceptions

Coverage Criteria and Exceptions

Coding — Listed Codes and Status

Provider Actions, Prior Authorization, and Documentation

Background and Scope

Definitions