CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

New Technology and Miscellaneous Services (Category III CPT® codes)

Defines BCBSRI coverage categories and guidance for CPT codes representing new and emerging technologies (primarily Category III CPT codes) for Medicare Advantage and Commercial products; affects providers submitting those procedure codes to Blue Cross & Blue Shield of Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyNew Technology and Miscellaneous Services (Category III CPT® codes)

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date12|01|2024

Next Review Date

Key ActionObtain prior authorization when required and consult the Code and Coverage Grid and related policies for specific medical criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Category IIIPrimary code category addressed

Medicare Advantage & CommercialProducts addressed

Covered / Not Covered / Preauth / Not reimbursed / AlternateMedicare Advantage coverage categories

Covered / Not Covered / Not Medically Necessary / Preauth rec / AlternateCommercial coverage categories

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General medical necessity criteria

Covered when ALL of the following medical necessity principles are satisfied:

Medical necessity requirements: Services/items must be consistent with the symptoms of the diagnosis, necessary and consistent with generally accepted professional medical standards (not experimental), not furnished primarily for convenience, and furnished at the most appropriate level of care.

From policy background

Coverage categories

Coverage stance options for procedure codes vary by product type:

Medicare Advantage coverage categories: Covered; Not Covered as the evidence is insufficient to determine the effects of the technologies on health outcomes; Preauthorization is required; Not separately reimbursed; Use alternate procedure code.

Listed coverage categories for Medicare Advantage

Commercial products coverage categories: Covered; Not Covered and a contract exclusion; Not medically necessary as the evidence is insufficient to determine the effects of the technologies on health outcomes; Preauthorization is recommended; Not separately reimbursed; Use alternate procedure code.

Listed coverage categories for Commercial products

Investigational device categories

Medicare Advantage device coverage guidance by FDA device category:

FDA Category A devices: Considered not medically reasonable and necessary and are therefore not covered.

Category A: experimental device where absolute risk has not been established.

FDA Category B devices: May be covered if they are considered medically reasonable and necessary and all other applicable Medicare coverage requirements are met.

Category B: non-experimental/investigational device where incremental risk is the primary question.

Benefits and coverage for procedures vary by member contract. Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for any contract-specific exclusions or "Health Care Services Not Covered" provisions that govern reimbursement and coverage determinations.

For Medicare Advantage products, procedure codes for new or unproven technologies fall into these categories: Covered; Not Covered (evidence insufficient); Preauthorization required; Not separately reimbursed; Use alternate procedure code.

For Commercial products, procedure codes for new or unproven technologies fall into these categories: Covered; Not Covered and a contract exclusion; Not medically necessary (evidence insufficient); Preauthorization recommended; Not separately reimbursed; Use alternate procedure code.

Procedures or technologies that are experimental or for which reliable evidence is insufficient to demonstrate safety or efficacy are considered not medically necessary. A treatment or procedure is not medically necessary when prevailing expert opinion or evidence indicates that further studies or clinical trials are required to determine safety, efficacy, toxicity, dosing, or comparative effectiveness.

For Commercial products, the policy explicitly includes a Not medically necessary category when evidence is insufficient; additionally, some items may be categorized as Not Covered due to a contract exclusion. Always review the applicable benefit booklet or subscriber agreement for product-specific distinctions.

Code and coding guidance

Code and Coverage Gridmixed

No codes listed

Category III archival timeline

Archival timelineCategory III CPT codes are generally archived five years from the date of initial publication or extension unless a modification is specifically noted at the time of revision or change.

Post-archival codingServices/procedures described by archived Category III codes that have not converted to Category I must be reported using a Category I unlisted code unless a specific cross-reference is established at the time of archiving.

Purpose of Category III codesTemporary codes to permit data collection on emerging technologies, services and procedures; if available, they must be reported instead of a Category I unlisted code.

Code release cadenceNew or revised Category III codes are released semi-annually via the AMA CPT website.

Category III CPT® codes — definition and reporting guidance

DefinitionCategory III CPT codes are temporary codes for emerging technology, services and procedures intended to allow collection of data on clinical efficacy, utilization, and outcomes.

Reporting requirementWhen a Category III CPT code exists for a service, it must be reported instead of a Category I unlisted code.

PurposeEnable physicians, payers, and researchers to identify and track emerging services/procedures for evidence development.

Conversion possibilityA Category III code may be archived or later converted to a Category I code if editorial requirements are met.

Provider requirements, prior authorization, and billing notes

Prior Authorization

Prior authorization required or recommended

For services that require prior authorization, refer to the Related Policies identified in the Code and Coverage Grid in the Coding section of this policy for applicable medical criteria and authorization requirements.

See the Coding section Code and Coverage Grid for plan-specific prior authorization details.
Medicare Advantage and Commercial products may have different prior auth rules — verify member plan.

Note

Provider action — verify member benefits

When submitting claims, follow benefit and booklet terms for coverage determinations. Benefits and eligibility are determined by the member's subscriber agreement, Evidence of Coverage, or employer agreement and may supersede policy statements.

Check the applicable Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for member-specific coverage.
If a service is determined to be a non-covered benefit, providers may not balance-bill members unless the member was informed and provided written consent in advance.

Documentation Required

Documentation and coding note

The majority of CPT codes in this policy are Category III CPT® codes. If a Category III code exists for a service, that code must be reported instead of a Category I unlisted code. Use Category I unlisted codes only when no Category III code is available.

Report the specific Category III CPT® code when available — do not use a Category I unlisted code in its place.
Category III codes are temporary; archived Category III codes without conversion must be reported with a Category I unlisted code unless another cross-reference is provided.

Denial Risk

Denial triggers and coverage variability

Procedures may be denied if the service is listed as Not Covered, Not medically necessary, excluded by contract, or otherwise unsupported by the member's benefit terms. Coverage categories differ between Medicare Advantage and Commercial products — confirm applicability to the member's plan.

Denial triggers include: 'Not Covered', 'Not medically necessary', contract exclusions, and services 'Not separately reimbursed'.
Preauthorization may be required (Medicare Advantage) or recommended (Commercial) — absence of required prior auth can result in denial.

Policy background

Category III CPT® codes are temporary codes established to report emerging technologies, services, and procedures and to facilitate data collection on clinical efficacy, utilization, and outcomes. The presence of a Category III code does not by itself indicate clinical efficacy or coverage; services reported with these codes must still meet the plan's medical necessity requirements (consistent with diagnosis, accepted standards of care, and not experimental) to be covered.

When a Category III code exists for a service, it should be used in place of a Category I unlisted code; documentation should support that the service meets medical necessity criteria and any applicable prior authorization requirements described in the policy and related coding grids.

Definitions and key terms

Medical necessity — definition and criteria

Medical necessity definitionItems and services must be consistent with the symptoms of the diagnosis, necessary and consistent with generally accepted professional medical standards (not experimental), not furnished primarily for convenience, and furnished at the most appropriate level of care.

Not medically necessary criteriaA treatment or procedure is not medically necessary if reliable evidence shows experts believe more studies or clinical trials are needed to determine safety, efficacy, toxicity, or comparative effectiveness.

Evidence requirementItems and services must be established as safe and effective to be considered medically necessary.

FDA Category A device — definition and Medicare Advantage stance

Definition (FDA Category A)Category A (Experimental) device: a device for which 'absolute risk' of the device type has not been established — initial questions of safety and effectiveness have not been resolved.

Medicare Advantage stanceCategory A devices are considered not medically reasonable and necessary and are therefore not covered for Medicare Advantage plans.

Coverage rationaleBecause initial safety/effectiveness questions remain unresolved, these devices do not meet medical necessity standards for coverage.

FDA Category B device — definition and coverage conditions

Definition (FDA Category B)Category B (Non-experimental/investigational) device: a device for which incremental risk is the primary risk in question — initial safety/effectiveness questions of the device type have been resolved or other manufacturers have obtained FDA approval/clearance for that device type.

Coverage conditionsCategory B devices may be covered for Medicare Advantage if they are considered medically reasonable and necessary and all other applicable Medicare coverage requirements are met.

Coverage implicationCoverage depends on meeting medical necessity and Medicare requirements rather than being categorically excluded.

OpenPayer

New Technology and Miscellaneous Services (Category III CPT® codes)

Coverage criteria and medical necessity

Code and coding guidance

Provider requirements, prior authorization, and billing notes

Policy background

Definitions and key terms