CurrentAetnaPolicy 0290

Scalp Cooling (Hypothermia) to Prevent Hair Loss During Chemotherapy

This bulletin governs use and reimbursement stance for scalp cooling devices/caps to prevent hair loss during chemotherapy for Aetna members; it addresses coverage limitations, coding, and supporting clinical evidence.

Policy Summary

PayerAetna

PolicyScalp Cooling (Hypothermia) to Prevent Hair Loss During Chemotherapy

Policy CodePolicy 0290

Change TypeNo material change

Effective DateOct 13, 1998

Next Review DateMar 14, 2024

Key ActionDo not bill scalp cooling separately; report cooling when provided with chemotherapy using chemotherapy administration codes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

66%DigniCap trial <50% hair loss

RR=0.38RR reduction (meta-analysis)

50-80%Typical response range

54Device AEs (Nangia)

0Clinical criteria present

Coverage Criteria

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Reimbursement coverage criteria

Covered when ALL of the following are met

Incidental to chemotherapy: Cooling caps and other scalp cooling products are considered incidental to chemotherapy administration and are not separately reimbursed; items purchased by the member are considered supplies and generally excluded under plans that exclude supplies.

Policy treats scalp cooling as non-separately reimbursable; billing should be with chemotherapy administration codes (e.g., CPT 96401-96450); CPT codes for scalp cooling (0662T, 0663T) are not payable separately.

Evidence-supported indications

Covered when ALL of the following are met (evidence basis):

Population and device evidence: Patient is undergoing chemotherapy with alopecia-inducing agents (e.g., anthracyclines, taxanes) and is a candidate for scalp cooling as described in trials (primarily stage I-II breast cancer); device is a scalp cooling system (e.g., DigniCap) with demonstrated reduction in hair loss in randomized and controlled trials.

Randomized and controlled trials report hair-preservation success rates roughly 50–80% depending on regimen; pivotal DigniCap study reported >66% with <50% hair loss; Nangia RCT and other trials demonstrated significantly less hair loss versus control.

Cooling caps and other scalp cooling products purchased by the member are considered supplies and are generally excluded from coverage. Aetna considers these devices incidental to chemotherapy administration and they are not separately reimbursed; benefit plan descriptions should be consulted for specific supply exclusions.

Do not use scalp cooling when chemotherapy is given with curative intent in patients with generalized hematogenic metastases. Published reviews have advised against use of scalp hypothermia in this population because of concerns about efficacy and potential risks in the setting of disseminated disease.

Contraindications: Scalp cooling is contraindicated in patients with cold sensitivity, cold agglutinin disease, cryoglobulinemia, and post‑traumatic cold dystrophy. Use is also discouraged or should be approached with caution in patients with circulating tumor cells (e.g., lymphoma, leukemia) or significant liver dysfunction that may prolong chemotherapeutic drug half‑lives.

This Clinical Policy Bulletin provides a partial, general description of plan or program benefits and is intended to assist in administering benefits; it does not constitute a contract and does not provide medical advice. Aetna may update the bulletin and treating providers remain solely responsible for medical management of members.

Routine use of scalp cooling is not recommended in settings where the risk of scalp metastasis is a concern. Because chemotherapy‑associated hair loss is typically transient and often reversible, counseling and psychological support should be prioritized over device use when potential oncologic risks exist.

Regimen / Agent	Effectiveness / Notes
Anthracyclines (e.g., doxorubicin, epirubicin)
Effectiveness variable; some studies report benefit with single-agent anthracyclines, but results are dose-dependent and higher anthracycline doses are associated with higher rates of alopecia despite cooling. Less favorable responses reported with certain combinations (see anthracycline-taxane combinations).

Regimen / Agent	Effectiveness / Notes
Taxanes (e.g., paclitaxel, docetaxel)
Generally associated with good-to-excellent response rates in many studies (overall 50–80% in pooled reports); Nangia and others reported ~50% success in mixed regimens with substantial taxane use. Effectiveness may vary by specific taxane and regimen.

Provider Actions, Billing & Prior Authorization

Denial Risk

Separate reimbursement not authorized

Aetna considers cooling caps and other scalp cooling products incidental to chemotherapy administration and they are not separately reimbursed. Cooling caps/products purchased by the member are considered supplies and may be excluded under plans that exclude supplies. If scalp cooling is billed, reference chemotherapy administration CPT codes (96401–96450) as appropriate; CPT codes specific to scalp cooling include 0662T (initial measurement and calibration of cap) and 0663T (placement, monitoring, and removal — list separately in addition to primary procedure).

Cooling caps/products are incidental to chemotherapy — not separately reimbursed
Member-purchased cooling caps may be excluded as supplies under some plans
If billed, reference chemotherapy administration CPT codes 96401–96450
Relevant CPT scalp cooling codes: 0662T, 0663T

Prior Authorization

Prior authorization expectation

Prior authorization expectations: evidence and device use are primarily described for scalp cooling during chemotherapy in breast cancer patients, particularly with anthracycline- or taxane-based regimens. Providers should verify plan-specific prior authorization requirements (if any) before scheduling scalp cooling.

Clinical evidence mainly in breast cancer patients receiving adjuvant/neoadjuvant chemotherapy
Prior authorization may be required per plan — check member benefits

Prior Authorization

Prior authorization — operational note

This excerpt does not specify any required prior authorization forms, codes, or an established prior authorization process. Providers must consult the member’s benefit plan or provider portal for any plan-specific prior authorization rules.

No specific prior authorization codes or forms provided in this bulletin
Check member benefits or provider portal for plan-specific prior auth details

Documentation Required

Contraindications and high‑risk conditions — document in chart

If scalp cooling is contraindicated (and therefore should not be used), document the clinical rationale. Contraindications or high-risk conditions include cold sensitivity disorders, cold agglutinin disease, cryoglobulinemia, post-traumatic cold dystrophy, circulating tumor cell–predominant malignancies (eg, lymphoma, leukemia), and liver dysfunction that may prolong chemotherapy exposure and reduce cooling effectiveness.

Contraindications: cold sensitivity, cold agglutinin disease, cryoglobulinemia, post-traumatic cold dystrophy
Use with caution or avoid in patients with circulating tumor cells (lymphoma, leukemia) or significant liver dysfunction

Documentation Required

Supporting clinical documentation

Clinical trial endpoints commonly used in supporting studies include clinician-assessed hair preservation using CTCAE grade 0–1 or Dean scale (≤50% hair loss) and patient-reported outcomes (wig use, quality of life, body image, anxiety/depression). Include such assessments or relevant documentation in the medical record when available to support the use of scalp cooling.

Efficacy endpoints: CTCAE grade 0–1 or Dean scale ≤2 (≤50% hair loss)
Document patient counseling, expected benefit, and any device-related adverse effects

Note

Provider note — plan benefits govern

This Clinical Policy Bulletin is a partial description and does not replace plan-specific benefit provisions or constitute a contract. Treating providers are responsible for documenting clinical decisions; consult plan disclosures and program provisions for coverage determinations.

Bulletin is informational — plan-specific benefits govern coverage
Refer to Plan Disclosures and Program Provisions for member-specific rules

Definitions

Scalp cooling — definition (hypothermia to prevent chemotherapy-induced alopecia)"},{

DefinitionScalp cooling (local hypothermia) to prevent chemotherapy-induced alopecia by reducing scalp blood flow and hair follicle activity.

Typical methodsIce packs/bandages or device-based cooling caps used during chemotherapy to reduce risk of hair loss.

MechanismCooling constricts scalp blood vessels and decreases hair follicle activity, reducing chemotherapy delivery to follicles.

DigniCap Cooling System — device description (cleared)

DeviceDigniCap Cooling System (Dignitana): a computer-controlled system that circulates cooled liquid to a head-worn cooling cap covered by a neoprene insulating cap.

IndicationCleared by the FDA to reduce frequency and severity of alopecia during chemotherapy in female breast cancer patients receiving alopecia-inducing agents and doses.

FunctionMaintains scalp cooling during chemotherapy to constrict scalp blood vessels and reduce chemotherapy exposure to hair follicles.

Treatment success (trial-defined) — hair preservation criteria

Trial-defined success (CTCAE)Hair preservation defined as CTCAE grade 0 or 1 (<50% hair loss not requiring a wig).

Trial-defined success (Dean scale)Dean scale score 0–2, defined as ≤50% hair loss.

Assessment timingHair preservation assessed ~4 weeks after the last chemotherapy cycle in cited trials.

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PlaceholderNo additional definition provided in this excerpt; reserved for future key-value entry.

StatusEmpty placeholder block included in inventory for potential future content.

NoteSee full Clinical Policy Bulletin for updates and additional definitions.

OpenPayer

Scalp Cooling (Hypothermia) to Prevent Hair Loss During Chemotherapy

Coverage Criteria

Chemotherapy Regimens and Effectiveness

Coding

Provider Actions, Billing & Prior Authorization

Definitions

Background

0662T	Scalp cooling, mechanical; initial measurement and calibration of cap.
0663T	Scalp cooling, mechanical; placement of device, monitoring, and removal of device (List separately in addition to code for primary procedure).