Capital Bluecross cooling devices Coverage Update

Coverage Criteria and Policy Position

Investigational / Not Covered with Clinical Rationale

Covered when ALL of the following are met:

Policy stance: Circulating and noncirculating cooling devices and combination circulating cooling and compression (cryopneumatic) devices are considered investigational due to insufficient evidence to conclude they improve health outcomes.

Based on mixed randomized trials and systematic reviews across knee, shoulder, and facial postoperative applications.

The following HCPCS codes are identified in the policy as investigational and not covered when billed for circulating, noncirculating, or combination cooling/compression devices: C9810, C9817, E0218, E0236, and E1399 (the latter when used to bill for a combination active cooling and compression device or for a noncirculating cooling device).

Policy history documents prior reviews and designation changes for cryopneumatic and related cooling devices. Entries note multiple consensus reviews with coding checks and reference updates; a 06/26/2024 entry recorded that cryopneumatic devices were changed from INV to NMN, and a 04/25/2025 review edited language from NMN back to INV. An administrative update on 12/11/2025 added new HCPCS codes C9810 and C9817 effective 01/01/2026.

Based on the available evidence, use of circulating and noncirculating cooling devices, as well as combination circulating cooling and compression (cryopneumatic) devices, is considered not medically necessary (investigational) for outpatient management of postoperative pain and swelling because the literature provides insufficient evidence of consistent net health benefit across relevant surgical applications.

Prior policy revisions have changed designations for cryopneumatic devices between Investigational (INV) and Not Medically Necessary (NMN). The current excerpt documents these historical designation changes but does not reproduce the full active policy text or the detailed policy guidelines created in the 06/26/2024 revision.

Procedure and HCPCS Coding

Investigational; therefore, not covered (HCPCS)HCPCSNot Covered

C9810	C9810
C9817	C9817
E0218	E0218
E0236	E0236
E1399	E1399 [when used to bill for a combination active cooling and compression (cryopneumatic) device or when used to bill for a noncirculating cooling device]

Updated HCPCS codes added to policyHCPCS

C9810	Newly added HCPCS code (documented in policy history)
C9817	Newly added HCPCS code (documented in policy history)

Provider Actions, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization and Benefit Determination

Prior authorization and benefit determination: These devices are considered investigational; coverage is determined by the member's benefit plan and prior authorization may be required. Providers must verify member eligibility and benefits before scheduling services.

Investigational devices are likely not covered under many benefit plans; check member-specific coverage.
Obtain prior authorization when required by the member's benefit plan.

Billing Rule

Use Current Codes for Authorization

Use current billing codes when requesting authorizations or submitting claims. Effective 01/01/2026, HCPCS codes C9810 and C9817 were added to the policy.

Evidence Summary and Medical Necessity Rationale

Evidence-based medical necessity rationale

Summary of the evidence that informed the medical necessity determination:

Evidence conclusion: Randomized trials and systematic reviews provide mixed or insufficient evidence that active circulating, noncirculating, or cryopneumatic cooling devices improve symptoms, functional outcomes, medication use, or other net health outcomes after knee, shoulder, or facial surgery.

Some trials showed no significant benefit compared with standard icing; one trial (N=100) found acute pain reduction, and small facial surgery trials were inconclusive.

Limitations: Many studies had heterogenous control conditions (varying ice frequency and methods), small sample sizes, and limited reporting of intervention details, limiting interpretation and generalizability.

These methodological issues contributed to the determination that evidence is insufficient for concluding net health benefit.

MEDICAL NECESSITY

Clinical trial and systematic review evidence cited in the policy; explicit durable medical equipment (DME) medical necessity criteria are not provided in the excerpt:

Rental, Purchase and Device Listings

Device / HCPCS code	Policy rental vs purchase rule
C9810
C9817
E0218
E0236
E1399 (when used for combination active cooling and compression or noncirculating cooling device)

Topic	Policy excerpt / Notes
Rental vs purchase rules present in policy excerpt
Not specified in this excerpt. The policy identifies the listed cooling device HCPCS codes as investigational and therefore not covered; rental versus purchase determinations would depend on member benefit and are not applicable within this policy portion.
Providers must confirm member benefit program and that services are medically necessary; medical policies do not guarantee coverage or payment.

Definitions and Device Types

Durable Medical Equipment — definition and inclusion criteria for DME

DefinitionDurable Medical Equipment (DME) consists of items primarily and customarily used to serve a medical purpose; not useful in the absence of illness or injury; ordered by a physician; appropriate for home use; reusable; and able to withstand repeated use.

Prescriber requirementMust be ordered by a physician as part of the member's treatment plan.

Intended settingAppropriate for use in the home (outpatient/home use).

DurabilityReusable and designed to stand repeated use rather than single-use disposables.

Cooling/cryotherapy device types — temperature-controlled continuous cold flow, cryopneumatic/compressive, circulating vs noncirculating

Temperature-controlled continuous cold flow devices

Clinical Background

Cold and compression therapy (cryotherapy) is commonly used postoperatively and after musculoskeletal or soft tissue injury to reduce pain and swelling. Devices range from simple ice packs and passive noncirculating systems to active circulating systems that may provide continuous cooled fluid circulation and pneumatic compression. Randomized trials and systematic reviews report mixed results: some small trials show transient pain reduction while several larger trials found no significant benefit. Overall, the evidence is insufficient to conclude these devices improve net health outcomes, which supports the policy's investigational stance.

Documentation Requirements

Documentation Required

Verify benefits and document medical necessity (reminder)

Providers must confirm member benefit eligibility and document medical necessity; the policy is not a guarantee of payment and final claim processing depends on the member's contract and eligibility at the time of service.

Documentation Required

Document justification for device type and coding

Include clinical justification for the selected device type and its intended use in the medical record, noting policy history that reviewed coding and product variations when relevant.

Document why a specific device (circulating, noncirculating, or combination) is being used.
Reference applicable HCPCS codes and policy rationale in documentation.

Not Covered Items

The policy explicitly states that circulating and noncirculating cooling devices and combination cooling/compression (cryopneumatic) devices are considered investigational and not covered. Claims billed with the HCPCS codes listed for these devices are subject to noncoverage per the policy coding section.

The provided excerpt does not include a current, explicit itemized list of specific durable medical equipment products that are separately labeled as not covered beyond the HCPCS code-level exclusions and the documented policy history. Providers should refer to the full policy or benefit terms for any product-specific determinations.

Replacement and Repair

Replacement — placeholder key/value for replacement guidance (excerpted document lacks explicit content)

Replacement guidance statusNo replacement intervals or explicit replacement guidance are specified in the excerpted policy; policy history and updates do not provide replacement rules in this excerpt.

Policy history notePolicy history documents coding and status changes (INV/NMN) and administrative updates but does not list replacement intervals.

Coverage dependencyIf an exception to investigational status applies, replacement coverage or intervals would be determined by member benefit provisions (not specified here).

OpenPayer

Cooling Devices Used in the Outpatient Setting