DraftBlue 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 codes) for Medicare Advantage and Commercial products; applicable to providers billing these services to BCBSRI members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyNew Technology and Miscellaneous Services (Category III CPT codes)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 12, 2025

Next Review DateJan 1, 2025

Key ActionObtain prior authorization when indicated and follow the Code and Coverage Grid for submission instructions.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Category IIIPrimary code type covered

Medicare Advantage & CommercialProducts addressed

MultipleDeterminations

Use Category IIICoding requirement

Coverage criteria and medical necessity

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General medical necessity

Coverage decisions and medical necessity follow product-specific categories and general medical necessity standards.

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

From policy background on medical necessity

Medicare Advantage coverage categories

Medicare Advantage coverage categories for procedure codes include:

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 coverage categories

Commercial product coverage categories for procedure codes include:

Commercial 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

Medicare Advantage investigational device stance

Device-specific coverage stance for Medicare Advantage

FDA device categories: Category A devices are not covered; Category B devices may be covered if medically reasonable and necessary and other Medicare requirements are met

Device categorization affects coverage

For Medicare Advantage members, services that involve devices categorized by the U.S. Food and Drug Administration as Category A (Experimental) are considered not medically reasonable and necessary and therefore are not covered. Category A devices are those for which the device type’s absolute risk has not been established and initial questions of safety and effectiveness remain unresolved.

A treatment or procedure is considered not medically necessary when reliable evidence shows that prevailing expert opinion indicates additional studies or clinical trials are needed to determine safety, efficacy, toxicity, maximum tolerated dose, or comparative effectiveness versus standard care. General medical necessity also requires that services be consistent with the symptoms/diagnosis, necessary and consistent with accepted professional medical standards (i.e., not experimental), not furnished primarily for convenience, and provided at the most appropriate level of care.

Provider requirements, prior authorization, and billing notes

Prior Authorization

Prior Authorization Required

Prior authorization is required when indicated. Follow the Code and Coverage Grid in the Coding section and any Related Policies for specific prior authorization requirements and medical criteria. Requirements may differ between Medicare Advantage and Commercial products.

See Coding section grid for product-specific prior authorization and related policy links.
Medicare Advantage and Commercial products may have different preauthorization rules.

Note

Coverage categories by product

For Medicare Advantage plans, BCBSRI classifies procedure codes for new and existing unproven technology into categories such as Covered; Not Covered (insufficient evidence); Preauthorization required; Not separately reimbursed; and Use alternate procedure code. For Commercial products, categories include Covered; Not Covered and a contract exclusion; Not medically necessary (insufficient evidence); Preauthorization recommended; Not separately reimbursed; and Use alternate procedure code.

Prior Authorization

Prior authorization source

Follow related policies and the Code and Coverage Grid in the Coding section for services that require prior authorization and for applicable medical necessity criteria.

Denial Risk

Benefit / contract mismatch

Benefits and coverage vary by contract. Services may be denied if they are not covered under the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement. Verify member benefits and applicable exclusions before providing services.

Denial Risk

FDA Category A device exclusion

FDA Category A (Experimental) devices are considered not medically reasonable and necessary and are not covered under Medicare Advantage plans. Category B devices may be covered if considered medically reasonable and necessary and all other Medicare coverage requirements are met.

Key definitions

Category III CPT codes — temporary codes for emerging technology

DefinitionTemporary CPT codes for emerging technology, services and procedures used to collect clinical and utilization data; must be reported when available instead of a Category I unlisted code.

PurposeAllow collection of data on utilization, efficacy and outcomes for emerging services and procedures.

Reporting requirementIf a Category III code is available, it must be reported instead of a Category I unlisted code.

LifecycleCategory III codes may be archived five years from initial publication unless modified; archived Category III codes revert to reporting with a Category I unlisted code unless cross-referenced.

Conversion possibilityCategory III codes may be converted to Category I if CPT Editorial Panel requirements are later met.

FDA Category A device — Experimental device (not covered)

DefinitionFDA Category A (Experimental) device: a device for which 'absolute risk' has not been established; initial questions of safety and effectiveness have not been resolved.

Coverage stanceConsidered not medically reasonable and necessary and therefore not covered for Medicare Advantage plans.

Primary concernUnresolved initial questions of safety and effectiveness for the device type.

Implication for providersServices using Category A devices should not be billed as covered under Medicare Advantage due to exclusion.

FDA Category B device — Non-experimental/investigational (may be covered if criteria met)

DefinitionFDA Category B (Non-experimental/investigational) device: a device for which initial questions of safety and effectiveness have been resolved; incremental risk is the primary question.

Coverage stanceMay be covered for Medicare Advantage if considered medically reasonable and necessary and all other applicable Medicare coverage requirements are met.

Evidence expectationInitial safety/effectiveness questions have been resolved, or similar device types have received FDA premarket approval or clearance.

Provider implicationCoverage requires demonstration of medical necessity and compliance with Medicare coverage rules before reimbursement is allowable.

OpenPayer

New Technology and Miscellaneous Services (Category III CPT codes)

Coverage criteria and medical necessity

Coding guidance and code tables

Provider requirements, prior authorization, and billing notes

Background on Category III CPT codes and context

Key definitions