Positron Emission Mammography (PEM)
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This policy governs the use of positron emission mammography for Capital BlueCross members and describes coverage stance, clinical rationale, and coding implications for providers.
No material clinical or coverage changes in this revision.
Coverage Criteria — Positron Emission Mammography (PEM)
Investigational / Not covered
Covered when ALL of the following are met
Supports noncoverage decision
Positron emission mammography (PEM) is not indicated for breast cancer screening because it delivers a substantially higher whole-body radiation dose compared with conventional mammography and many alternative imaging tests. The American College of Radiology assigns a relative radiation level of 10–30 mSv to PEM and has stated that, because of radiation dose, PEM (and related molecular breast imaging techniques) are not indicated for screening. In addition, available evidence has not demonstrated improved diagnostic accuracy or clinical utility for PEM compared with established comparators, so the higher radiation exposure is not justified for screening.
Positron Emission Mammography (PEM) reported with procedure code 78999 is designated investigational and is not covered. The policy explicitly lists code 78999 as investigational when used to report PEM and states that use of PEM is considered investigational.
The evidence reviewed has not demonstrated that PEM provides superior diagnostic accuracy or clinical utility for screening, presurgical evaluation, or evaluation of suspicious breast lesions compared with relevant comparators. Multiple studies and reviews fail to show improved outcomes, and without demonstrated clinical benefit the relatively high radiation dose associated with PEM weighs against its routine use for these indications.
Because PEM has been designated investigational, procedures billed using the unlisted/investigational code 78999 for PEM are considered not medically necessary for coverage purposes. Claims for PEM reported with this code may be denied under the investigational designation.
Covered and Not Covered Indications
Screening, presurgical evaluation, and workup of suspicious lesions — investigational
PEM is investigational for the following evaluated indications (evidence insufficient to establish clinical utility):
Evidence has not demonstrated that PEM provides better diagnostic accuracy or clinical utility than relevant comparators; relatively higher radiation dose does not favor its use.
Document cites studies on PEM performance and comparisons to MRI but provides no covered clinical indications in these chunks.
The document cites studies and reviews evaluating PEM performance but does not establish covered clinical indications in these sections:
References support clinical evaluation but do not change investigational stance.
Services Not Covered
NOT COVERED — Positron emission mammography (PEM) is not covered for breast cancer screening. The American College of Radiology has rated PEM as usually not appropriate for screening and has noted the high radiation exposure associated with PEM compared with mammography and other modalities; evidence does not show a net clinical benefit for screening use.
Coding and Dose Information
| 78999 | Procedure code listed as investigational when used to report Positron Emission Mammography (PEM) |
| 78999 | Unlisted procedure, investigational when used to report Positron Emission Mammography (PEM); therefore, not covered |
Provider Actions and Billing Guidance
Product-specific applicability
This medical policy is applicable only to certain Capital Blue Cross products and programs. Benefit terms may vary by product; providers should verify product-specific coverage and any applicable benefit variations prior to scheduling or billing services.
- Applicable to certain Capital Blue Cross programs and products
- Refer to member-specific benefit plan for coverage details
Investigational — Not Covered
Positron emission mammography (PEM) is considered investigational and is not covered under Capital Blue Cross policies. Prior authorization does not change coverage status; obtaining prior authorization will not make PEM a covered service.
- PEM is investigational — not covered
- Prior authorization will not render investigational services covered
Investigational coding triggers denial
Procedure code 78999 when used to report PEM is classified as investigational and may trigger claim denial. Claims billed with this code for PEM should be expected to be denied as not covered.
Documentation related to investigational code
When submitting claims or prior authorization requests, include clear documentation that supports medical necessity for any imaging performed. Note that documentation alone will not change the investigational coverage determination for PEM; however, accurate records are required for claim adjudication and appeals.
- Include clinical rationale and relevant prior imaging or pathology reports
- Document dates of service, ordering provider, and indications for imaging
Provider action — verify eligibility and benefits
Verify member eligibility and benefits prior to ordering services. Contact Capital Blue Cross Provider Services or Member Services for product-specific questions, benefit verification, and claim submission guidance.
- Confirm member eligibility and benefit limits on the date of service
- Contact Provider Services or Member Services for coverage confirmation
Background and Clinical Rationale
BACKGROUND — Positron emission mammography (PEM) is a dedicated, high-resolution PET technique for imaging the breast that uses the radiotracer F-18 fluorodeoxyglucose (FDG). PEM systems typically use miniaturized high-resolution detectors, often with compression paddles, to provide functional imaging of the breast with higher spatial resolution than standard whole-body PET; however, PEM exposes the body to greater radiation than mammography because organs beyond the breast receive dose from the injected radiotracer.
Definitions
Contrast and Tracer Rules
Contrast and radiotracer rules for PEM
PEM requires administration of an injected radiotracer (typically F-18 FDG); there are no iodinated or gadolinium contrast agent rules specified in this policy.
- Label-recommended FDG dose for PEM is noted elsewhere in the policy (370 MBq / 10 mCi).
Policy Revision History
Administrative update: Removed NCCN Statement; updated Benefit Variations section and Disclaimer.
Consensus review with no changes to policy statement; coding reviewed with no changes.
Consensus review with no change to policy statement; references updated.
Consensus review with no change to policy statement; references updated.
Consensus review with policy statement unchanged; references updated.
Major review: removed criteria for mammogram, continued as covered service; background, rationale, coding, and references updated.
Administrative update: Note on preventive mammography updated to reflect the appropriate document.
Consensus review: no change to policy statement; coding reviewed with no changes; Product Variation Statement updated; references reviewed and updated.
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