Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Positron Emission Mammography (PEM)
Policy #:MA09.015

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

Positron emission mammography (PEM) is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.
Policy Guidelines

There is no Medicare coverage criteria addressing this service; therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, positron emission mammography (PEM) is not eligible for payment under the medical benefits of the Company’s Medicare Advantage products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are excluded for the Company’s Medicare Advantage products. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The PEM 2400 PET Scanner was approved by the FDA on August 13, 2003, for medical purposes to image and measure the distribution of injected positron-emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.

The Naviscan PEM Flex™ Solo II High Resolution PET Scanner was approved by the FDA on March 31, 2009, as a high spatial resolution, small field-of-view PET imaging system specifically developed for close-range, spot (i.e., limited field) imaging.

Description

Positron emission mammography (PEM) is a relatively new form of positron emission tomography (PET) scanning that is used specifically for the breast. PEM is a molecular imaging examination of the breast that utilizes a glucose-based tracer, 18F-fluorodeoxyglucose (FDG), that detects metabolic activity in cancer cells. Cancer cells use more glucose (sugar) to fuel rapid growth than healthy tissue cells do; therefore, the cancer will show as 'hot' spots in PEM images. It is purported that PEM allows for the detection of breast cancer cells at a stage where they are not often detectable by other screening methods such as mammography, ultrasound, or FDG-PET.

A single-arm study performed by Tafra et al (2005) and Berg et al (2006) provided preliminary data on the sensitivity of PEM imaging for breast cancer. Two additional studies addressed in three articles by Schilling et al (2011) and Berg et al (2011, 2012) are important because they compare the use of PEM and magnetic resonance imaging (MRI) in presurgical planning. Both studies have their limitations, such as single site, lack of full blinding to results of alternate test, and lack of adjustment for multiple comparisons. The apparent differences between PEM and MRI may be due to the selection of different operating points on the receiver operating characteristic (ROC) curve. In one study, it is reported that PEM provides added information in the form of higher sensitivity for detecting ductal carcinoma in situ (DCIS). Additional studies will need to be performed to confirm these findings. If the addition of PEM to MRI in the detection of breast cancer diagnosis improves accuracy, this finding must be weighed against the potential risk from radiation exposure with PEM.

PRACTICE GUIDELINES AND POSITION STATEMENTS

The American College of Radiology includes PEM in two sets of Appropriateness Criteria: one on breast screening and the other on the initial diagnostic work-up of breast microcalcifications. For breast cancer screening, PEM is given a rating of 2 (usually not appropriate) for its use in screening women at high or intermediate risk of breast cancer and a 1 (usually not appropriate) for screening women at average risk of breast cancer. It also assigns a relative radiation level of 10 to 30 mSv. It also notes that “Radiation dose from BSGI and PEM are 15-30 times higher than the dose of a digital mammogram, and they are not indicated for screening in their present form.” For the initial diagnostic work-up of breast microcalcifications, PEM was assigned a rating of 1 (usually not appropriate) for the initial work-up of all 18 variants of microcalcifications. The authors note “The use of magnetic resonance imaging (MRI), breast specific gamma imaging (BSGI), positron emission mammography (PEM), and ductal lavage in evaluating clustered microcalcifications has not been established…. In general, they should not be used to avoid biopsy of mammographically suspicious calcifications."
References

American College of Radiology (ACR). ACR Appropriateness Criteria®. Palpable Breast Masses. 2016. Available online at: https://acsearch.acr.org/docs/69495/Narrative/. Accessed April 6, 2018.

American College of Radiology (ACR). ACR Appropriateness Criteria® Breast cancer screening. 2016. Available online at: https://acsearch.acr.org/docs/70910/Narrative/. Accessed April 6, 2018.

AIM Speciality Health. Clinical Appropriateness Guidelines: Advanced Imaging [AIM Web site]. 2014. Available at: http://www.aimspecialtyhealth.com/clinical-guidelines/agreement-accepted. Accessed January 29, 2015.

Berg WA, Madsen KS, Schilling K, et al. Breast cancer: Comparative effectiveness of positron emission mammography and MR imaging in presurgical planning for the ipsilateral breast. Radiology. 2011; 258(1):59-72.

Berg WA, Madsen KS, Schilling K, et al. Comparative effectiveness of positron emission mammography and MRI in the contralateral breast of women with newly diagnosed breast cancer. AJR Am J Roentgenol. 2012; 198(1):219-232.

Berg WA, Weinberg IN, Narayanan D, et al. High-resolution fluorodeoxyglucose position emission tomography with compression (“position emission mammography”) is highly accurate in depicting primary breast cancer. Breast J. 2006; 12(4):309-323.

Berrington de Gonzalez A, Berg CD, Visvanathan K, et al. Estimated risk of radiation-induced breast cancer from mammographic screening for young BRCA mutation carriers. J Natl Cancer Inst. 2009; 101(3):205-209.

Birdwell RL, Mountford CE, Iglehart JD. Molecular imaging of the breast. Am J Roentgenol. 2009; 193(2):367-76.

Caldarella C, Treglia G, Giordano A. Diagnostic Performance of Dedicated Positron Emission Mammography Using Fluorine-18-Fluorodeoxyglucose in Women With Suspicious Breast Lesions: A Meta-analysis. Clin Breast Cancer. 2014; 14(4):241-8.

Eo JS, Chun IK, Paeng JC, et al. Imaging sensitivity of dedicated positron emission mammography in relation to tumor size. Breast. 2012; 21(1):66-71.

Ernestos B, Nikolaos P, Koulis G, et al. Increased chromosomal radiosensitivity in women carrying BRCA1/BRCA2 mutations assessed with the G2 assay. Int J Radiat Oncol Biol Phys. 2010; 78(4):1199-1205.

Glass SB, Shah ZA. Clinical utility of positron emission mammography. Proc (Bayl Univ Med Cent). 2013; 26(3):314-9.

Greene LR, George RF. Radiologist views of positron emission mammography. Radiol Technol. 2012; 84(1):18-30.

Hendrick RE. Radiation doses and cancer risks from breast imaging studies. Radiology. 2010; 257(1):246-253.

Kalinyak JE, Berg WA, Schilling K et al. Breast cancer detection using high-resolution breast PET compared to whole-body PET or PET/CT. Eur J Nucl Med Mol Imaging. 2014; 41(2):260-75.

Kalles V, Zografos GC, Provatopoulou X, et al. The current status of positron emission mammography in breast cancer diagnosis. Breast Cancer. 2013; 20(2):123-30.

Khatcheressian JL, Hurley P, Bantug E, et al. Breast cancer follow-up and management after primary treatment: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2013; 31(7):961-5.

Mainiero MB, Lourenco A, Mahoney MC, et al. ACR Appropriateness Criteria Breast Cancer Screening. J Am Coll Radiol. 2013; 10(1):11-4.

Narayanan D, Madsen KS, Kalinyak JE, et al. Interpretation of positron emission mammography: feature analysis and rates of malignancy. AJR Am J Roentgenol. 2011; 196(4):956-970.

Narayanan D, Madsen KS, Kalinyak JE, et al. Interpretation of positron emission mammography and MRI by experienced breast imaging radiologists: performance and observer reproducibility. AJR Am J Roentgenol. 2011; 196(4):971-981.

National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: breast cancer screening and diagnosis, version 1.2017. Available online at:
http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#detection. Accessed April 6, 2018.

O'Connor MK, Li H, Rhodes DJ, et al. Comparison of radiation exposure and associated radiation-induced cancer risks from mammography and molecular imaging of the breast. Med Phys. 2010; 37(12):6187-6198.

Prekeges J. Breast imaging devices for nuclear medicine. J Nucl Med Technol. 2012; 40(2):71-8.

Research Council of the National Academies. Health risks from exposure to low levels of ionizing radiation: BEIR VII, Phase 2---Committee to Assess Health Risks for Exposure to Low Levels of Ionizing Radiation. Washington, DC: National Academies Press, 2006.

Schilling K, Narayanan D, Kalinyak JE, et al. Positron emission mammography in breast cancer presurgical planning: comparisons with magnetic resonance imaging. Eur J Nucl Med Mol Imaging. 2011; 38(1):23-36.

Shkumat NA, Springer A, Walker CM et al. Investigating the limit of detectability of a positron emission mammography device: a phantom study. Med Phys. 2011; 38(9):5176-85.

Surti S. Radionuclide methods and instrumentation for breast cancer detection and diagnosis. Semin Nucl Med. 2013; 43(4):271-80.

Tafra L, Cheng Z, Uddo J, et al. Pilot clinical trial of 18F-fluorodeoxyglucose positron-emission mammography in the surgical management of breast cancer. Am J Surg.2005; 190(4):628-632.

Tafreshi NK, Kumar V, Morse DL, et al. Molecular and functional imaging of breast cancer. Cancer Control. 2010; 17(3):143-55.

Up to Date. MRI of the breast and emerging technologies. 11/16/2016. Available at: http://www.uptodate.com [via subscription only]. Accessed April 6, 2018.

U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health. PEM 2400 PET Scanner. 510(k) summary. [FDA Web site]. 08/18/2003. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/k032063.pdf. Accessed April 6, 2018.

U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health. PEMFlex Solo II High Resolution PET Scanner. 510(k) summary. [FDA Web site]. 03/31/2009. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090553.pdf. Accessed April 6, 2018.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

G0252 PET imaging, full and partial-ring PET scanners only, for initial diagnosis of breast cancer and/or surgical planning for breast cancer (e.g., initial staging of axillary lymph nodes)


Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA09.015
05/23/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on positron emissions mammography.
06/07/2017This policy has been reissued in accordance with the Company's annual review process.
03/16/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Positron Emission Mammography (PEM).
03/05/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on Positron Emission Mammography (PEM). The Naviscan PEM Flex™ Solo II High Resolution PET Scanner was added under FDA status.
01/01/2015This is a new policy.





Version Effective Date: 01/01/2015
Version Issued Date: 01/01/2015
Version Reissued Date: 05/23/2018