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MolDX: Oncotype DX® Breast Cancer for DCIS (Genomic Health™)

L36951

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
CGS Administrators, LLC	MAC - Part A	15101 - MAC A	J - 15	Kentucky
CGS Administrators, LLC	MAC - Part B	15102 - MAC B	J - 15	Kentucky
CGS Administrators, LLC	MAC - Part A	15201 - MAC A	J - 15	Ohio
CGS Administrators, LLC	MAC - Part B	15202 - MAC B	J - 15	Ohio

LCD Information

Document Information

LCD ID
L36951

LCD Title
MolDX: Oncotype DX® Breast Cancer for DCIS (Genomic Health™)

Proposed LCD in Comment Period
N/A

Source Proposed LCD
DL36951

Original Effective Date
For services performed on or after 03/06/2017

Revision Effective Date
For services performed on or after 09/28/2023

Revision Ending Date
N/A

Retirement Date
N/A

Notice Period Start Date
01/19/2017

Notice Period End Date
03/05/2017

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Issue

Issue Description

Provide limited coverage for the Oncotype DX® DCIS assay (Genomic Health, Inc., Redwood City, CA) for women diagnosed with DCIS who are planning on having breast conserving surgery and considering adjuvant radiation therapy.

CMS National Coverage Policy

Title XVIII of the Social Security Act §1862(a)(1)(A) allows coverage and payment for those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

42 Code of Federal Regulations (CFR) 410.32(a) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

CMS Internet Only Manuals, Pub 100-02 Medicare Beneficiary Policy Manual chapter 15, §80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, §80.1.1 Certification Changes

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

This contractor will provide limited coverage for the Oncotype DX® DCIS assay (Genomic Health, Inc., Redwood City, CA) for women diagnosed with DCIS who are planning on having breast conserving surgery and considering adjuvant radiation therapy.

Summary of Evidence

Ductal carcinoma in situ (DCIS) is a heterogeneous group of neoplastic lesions confined to the breast ducts and lobules. It is one of the most commonly diagnosed breast conditions, accounting for approximately 20% of newly diagnosed breast cancers in the United States.¹ Women diagnosed with DCIS are at risk for local recurrence, which may be either DCIS or progression to invasive breast carcinoma. The management of patients with DCIS is an area of controversy and historically treatment has included both surgical excision and radiation therapy.²Following surgical excision alone local recurrences occur in approximately 25% to 30% of women by 10 years.³ The addition of radiation therapy has been reported to reduce local recurrence risk by approximately 50% but has not been demonstrated to prolong overall or disease free-survival.³ In an observational study of patients diagnosed with DCIS from 1988 to 2011, prevention of invasive in-breast recurrence with radiation therapy after lumpectomy did not improve 10-year breast cancer-specific mortality compared with lumpectomy alone.⁴ Therefore, treating all women with radiation therapy following surgical excision may represent overtreatment for many, especially given that the majority of cases do not recur following surgery alone. Clinical and pathologic features do not reliably predict the risk of recurrence; therefore, validated biomarkers are needed that identify patients at low risk of local recurrence for whom less treatment is indicated and conversely distinguish patients at high risk of progression to invasive disease for whom more intensive treatment regimens are appropriate.

Oncotype DX® DCIS Score

Test Description

The DCIS Score is a ribonucleic acid (RNA) based assay measuring the expression of 5 proliferation genes, progesterone receptor (PR), GSTM1 and 5 reference genes (Figure 1) with results reported as a numerical score along with accompanying interpretive information. The assay is performed on formalin fixed paraffin-embedded (FFPE) tissue blocks containing DCIS. The DCIS Score was developed based upon analyses of multiple correlative science studies comparing gene expression profiles between invasive and DCIS tumor samples.⁵ An algorithm was developed using scaling and category cut-points based on the analysis of the DCIS Score result in a separate cohort of DCIS patients.⁶

Figure 1: Genes Comprising the DCIS Score.

Proliferation Group	Hormone Receptor Group	Reference Group
Ki67 STK15 Survivin CCNB1 (cyclin B1) MYBL2	PR GSTM1	ACTB (ß -actin) GAPDH RPLPO GUS TFRC

Test Performance
Initial validation of the DCIS Score result was performed in a prospectively designed study of archived tumor specimens from 327 patients who participated in the previously described E5194 trial, a prospective cooperative group trial that evaluated 5- and 10-year ipsilateral breast event (IBE) rates after local excision alone in a selected population of patients with DCIS.^7,8 The study met its primary objective, as the DCIS Score result was predictive of the 10-year risk of any IBE. The DCIS Score result as a continuous variable was significantly associated with developing an IBE (hazard ratio [HR]/50 units=2.31, 95% CI = 1.15-4.49; p = 0.02). Using 3 pre-specified risk groups (low < 39, intermediate 39-54, and high = 55), the 10-year risk of any IBE (DCIS or invasive carcinoma) was 10.6% in the low risk group compared to 26.7% in the intermediate risk group and 25.9% in the high risk group; the risk stratification between the 3 groups was significant (log rank p = 0.006). The risk for developing ipsilateral invasive carcinoma was only 3.7% in the low risk group compared to 19.2% in the high risk group (log rank p = 0.003). Approximately 70% of all patients enrolled in the study were in the low risk group. In multivariable analyses, the DCIS Score result, tumor size, and menopausal status were identified to be statistically significant predictors of the risk of local recurrence (p = 0.02). The HR for the score remained unchanged after adjusting for tumor size and menopausal status thereby demonstrating that the DCIS Score result provides independent prognostic information beyond these risk factors.

The second prospectively designed clinical validation study of the Oncotype DX® Breast DCIS Score Assay was conducted in a population-based cohort of women diagnosed with DCIS and treated with breast conserving therapy alone from 1994-2003 in Ontario, Canada.⁹ The final study cohort included 718 patients of whom 571 had negative surgical margins. Median follow-up was 9.6 years. The study found the DCIS Score result to independently predict and quantify local recurrence risk. In the primary analysis, the DCIS Score result was significantly associated with any local recurrence in estrogen receptor positive patients (HR/50 units = 2.26, 95% CI = 1.41-3.59; p < 0.001) as well as all patients regardless of estrogen receptor status (HR = 2.15; 95% CI = 1.43-3.22; p < 0.001). For the same pre-specified risk groups (low < 39, intermediate 39-54, and high = 55), the 10-year risk of a local invasive carcinoma recurrence was 8.0% in the low risk group compared with 20.9% and 15.5% in the intermediate and high risk groups, respectively; the risk stratification between the 3 groups was significant (p = 0.03). The risk of developing a DCIS local recurrence was 5.4% in the low risk group compared with 14.1% and 13.7% in the intermediate and high risk groups, respectively (p = 0.002). In multivariable analysis, the DCIS Score result was a significant predictor of local recurrence (HR/50 units = 1.68, 95% CI = 1.08-2.62; p = 0.02) and provided independent recurrence risk information beyond clinical and pathologic measures including age at diagnosis, tumor size, grade, necrosis, multifocality, and subtype. The primary analyses were restricted to patients with clear margins; however, secondary analysis included all patients regardless of surgical margins. The HR in the expanded cohort, adjusting for margin status and other clinical and pathological features, was 2.11 (95% CI = 1.43-3.09; p < 0.001) indicating that the DCIS Score result effectively risk-stratifies patients regardless of margin status.

The analytical and clinical performance of the Oncotype DX® DCIS assay is summarized below.

Intended Use	To assess the average 10 year rate for any ipsilateral breast event (DCIS or invasive carcinoma) in women diagnosed with DCIS who had breast conserving surgery with negative margins and are considering adjuvant radiation therapy.
Validated Specimen Type(s)	FFPE tissue

Analytical Performance

Description	Results
Precision, within RNA extract (2 operator; 2 runs on different days; 2 manufacturing reagent lot; 5 PCR robots; 9 PCR detection systems; 75 paired RNA extracts run all in CLIA lab; expected score range 3-86*)	Within RNA Extracts
	DCIS Score Category	N	STD
	Low	36	1.04
	Int-High	39	1.09
Precision, between tumor block sections (2 operator; 2 runs on different days; 2 manufacturing reagent lot; 5 PCR robots; 9 PCR detection systems; 39 unique tumor blocks run all in CLIA lab; expected score range 3-86*)	Between Consecutive Tumor Block Sections
	DCIS Score Category	N	STD
	Low	19	2.11
	Int-High	20	3.96
Analytical sensitivity: Minimum input	Total RNA: 110 ng extracted from tumor tissue
Critical reagent closed/shelf-life stability (GHI conducted shelf-life stability unless stated otherwise)	Reverse Transcription Kit Stability from date of receipt through the manufacturer's labeled expiration date with 12 months of on-site storage at -20 °C ± 5 °C
	GSP pool (gene specific primers for reverse transcription) 9 months at -20 °C ± 5 °C
	Reverse Transcription Positive control 2 years at -80 °C ± 10 °C
	P3 Plate 9 months -80 °C ± 10 °C
	Human gDNA (quantitative PCR positive control) 6 months at +5 °C ± 3 °C
	Quantitative PCR Master Mix 18 months from date of manufacturing at -20 °C ± 5 °C
Critical reagent open/in use stability (GHI conducted operational stability unless stated otherwise)	Reverse Transcription Kit Use within 2 shifts after opening kit and prior to manufacturer's labeled expiration date at -20 °C ± 5 °C
	GSP pool (gene specific primers for reverse transcription) Freeze thaw no more 10x
	Reverse Transcription Positive control Single Use Tube
	P3 Plate Freeze thaw no more than 10x Use within 1 day 5 °C ± 3 °C
	Human gDNA (quantitative PCR positive control) 6 months at +5 °C ± 3 °C
	Quantitative PCR Master Mix 3 months after thaw at 5 °C ± 3 °C Up to 3 hours prior to qPCR plate assembly at room temperature (18 °C to 25 °C)
	Assembled Quantitative PCR plates 24 hours at room temperature (18 °C to 25 °C)
Specimen stability, primary	FPET slice in tube 6 months at room temperature (18 °C to 25 °C)
Specimen stability, intermediate (extracted RNA)	Within 1 day 5 °C ± 3 °C Within 5 days -20 °C ± 5 °C Within 365 days at -80 °C ± 10 °C
Specimen stability, intermediate (cDNA Sample plate)	Within 3 months at -20 °C ± 5 °C

* DCIS Score risk groups were specified prior to first clinical validation study (DCIS Score: Low <39, Intermediate 39-54, High =54). Actual range of DCIS scores for samples used for precision studies were DCIS Score Low 3-37 and DCIS Score Int-High 40-86.

Clinical Performance

The Oncotype DX® DCIS Score is a continuous measure that provides predicted risks of an ipsilateral breast event for individual patients over a continuum of gene expression, reflecting the continuous nature of tumor biology. Statistics. such as sensitivity and specificity, were designed to evaluate the general predictive ability of binary (dichotomous) predictors of the presence or absence of a disease or condition, rather than prediction of the risk of a future event, and have limitations in the assessment of continuous predictors of risk.^{10, 11, 12} A more appropriate statistical assessment of the predictive accuracy of the DCIS Score for risk groups is demonstrated by the width of the 95% confidence intervals for estimates of 10-year risk of an IBE within each risk group, shown in the table below.

The Oncotype DX® DCIS Score was validated in 2 clinical studies encompassing the indicated patient population. Both clinical validation studies were conducted under IRB-approved protocols with pre-specified analytical and quality acceptance criteria, statistical analysis plans, and endpoints. All clinical studies were conducted on the platform (device) after assay performance requirements (above) were specified and independently validated.

Description	Results
Description	Solin et al., 2013⁸ (n = 327 patients)	Rakovitch et al., 2015⁹ (n = 571 patients)
Hazard ratio/50 units	2.31^a (95% Cl = 1.15 - 4.49) p = 0.02	2.15^b (95% Cl = 1.43 - 3.22) p < 0.001
Number (%) of patients
Low DCIS Score	230 (70%)	355 (62%)
Intermediate/High DCIS Score	97 (30%)	216 (38%)
10-year Risk of Local Recurrence (95% CI)
Low DCIS Score	10.6% (6.9-16.2%)	12.7% (9.5-16.9%)
Intermediate/High DCIS Score	26.2% (18.1-37.0%)	30.1% (23.9-37.5%)
Overall Proportion with IBE^c	46/327 (14.1%)	100/571 (17.5%)

^aAdjusted for tamoxifen use (pre-specified primary analysis)
^bNo covariate adjustment; all patients (irrespective of ER status) with negative resection margins
^clpsilateral breast event (DCIS or invasive carcinoma)

Decision Impact and Health Economic Studies

A prospective multicenter clinical utility study evaluating the impact of the DCIS Score result upon treatment recommendations for radiation therapy (XRT) has been reported.¹³ Eligible women had newly diagnosed histologically documented DCIS and were candidates for breast conserving therapy. Physicians completed standardized questionnaires that captured their estimates of local recurrence risk and treatment recommendations for XRT, prior to and after receiving the DCIS Score results. A total of 115 evaluable patients from 10 US centers were included in final analyses. Study results found a significant change in the proportion of patients receiving recommendations for XRT pre- vs post-DCIS Score result (P = 0.008; McNemar’s test). Pre-assay, 73.0% of patients were recommended to receive XRT; this was reduced to 59.1% post-assay. Overall integration of the DCIS Score result into clinical management decisions resulted in a 31.3% change in XRT recommendations. Changes in treatment were bidirectional, indicating that the information was useful both for identifying patients at lower risk of recurrence for whom XRT may be omitted, as well as those at higher risk who may be appropriate candidates for more intensive modalities.

In a second prospective multicenter clinical utility study,¹⁴ 27 surgeons and 27 radiation oncologists at 13 US centers provided estimates of local recurrence risk and XRT recommendations for 127 patients, before and after DCIS Score results were known. Baseline characteristics of this patient cohort were similar to those of the first clinical utility study. Post-assay, 26.4% of recommendations changed overall , representing 22.0% of recommendations by radiation oncologists and 30.7% of recommendations by surgeons. The DCIS Score result was the most frequently cited reason for post-assay treatment recommendations.

Young et al. reported a retrospective health economic study from a single center involving 38 patients for whom the DCIS Score assay had been ordered.¹⁵ In this cohort, 26 patients (68%) had DCIS Score results and local recurrence risk considered low enough to omit radiation from their course of therapy. The authors concluded that the assay has the potential to be cost-saving to the healthcare system and spare many patients from the adverse effects associated with radiation therapy. A cost-effectiveness modeling study comparing the Oncotype DX® Breast DCIS Score Assay to standard clinical assessment to determine treatment recommendation for radiation therapy has been reported by Alvarado et al.¹⁶ The study found that on average, the assay was more cost-effective than the clinical assessment strategy by approximately $1000/patient, with similar life expectancies (17.15 vs 17.11, respectively) and quality-adjusted life-years (QALYs) (16.777 vs 16.789).

Criteria for Coverage

The Oncotype DX® DCIS assay is covered only when the following clinical conditions are met:

Pathology (excisional or core biopsy) reveals ductal carcinoma in situ of the breast (no pathological evidence of invasive disease), and
FFPE specimen with at least 0.5 mm of DCIS length, and
Patient is a candidate for and is considering breast conserving surgery alone as well as breast conserving surgery combined with adjuvant radiation therapy, and
Test result will be used to determine treatment choice between surgery alone vs. surgery with radiation therapy, and
Patient has not received and is not planning on receiving a mastectomy.

Analysis of Evidence (Rationale for Determination)

Level of Evidence

Quality – Moderate

Strength – Limited

Weight - limited

This contractor recognizes that evidence of clinical utility for the Oncotype DX® DCIS assay for women diagnosed with DCIS who are planning on having breast conserving surgery and considering adjuvant radiation therapy is promising at the current time. However, this contractor believes the ongoing collection studies with data elements identified below will generate sufficient data to demonstrate the utility of this assay in women with DCIS. Continued coverage is dependent bi-annual data submission and defined endpoints.

CGS Administrators expects Genomic Health to:

Ensure that healthcare providers who order the DCIS Score understand the appropriate patient population for testing and how to interpret test results; and
Report utilization by DCIS Score risk category on a bi-annual basis; and
Continue data development providing further evidence of clinical utility for the DCIS Score. During coverage with data development, evidence will be generated from Medicare patients receiving the DCIS Score. The nature and extent of this data is dependent on the volume of testing, specific disease context, and data elements required to support the test’s utility. De-identified data should be collected through HIPAA-compliant mechanisms.
For the DCIS Score, collected data elements include:
- Histologic subtype
- Pathological grade
- Size
- Presence of necrosis
- Multi-focality as reported on pathology report
- ER, PR and Her-2 Neu Status as reported on pathology report

Date of DCIS diagnosis
DCIS pathology including:

Treatment received (local: surgery +/- radiation, systemic: hormonal therapy)
Any ipsilateral recurrence during the period of data development (DCIS and/or Invasive cancer recurrences).

Provide bi-annual data updates to include:

Number of tested patients for which data is being collected
- Proportion of DCIS score Low Risk patients receiving breast conserving surgery alone
- Proportion of High-Risk and Intermediate-Risk DCIS score receiving radiation therapy.
- 3-year ipsilateral recurrence rates in DCIS score Low Risk patients receiving breast-conserving surgery alone
- 3-year ipsilateral recurrence rates for DCIS score Intermediate and High Risk patients receiving breast-conserving surgery plus radiation.
- Clinical management (i.e., adjuvant radiation procedures) for patients who are low or high risk by the DCIS assay is consistent with the post-test strategy described below for at least 80% of tested patients

Completeness of the collected data elements
Updates on the analysis supporting test utility including:

Oncotype DX® DCIS assay	Post-Test Diagnostic Strategy to Consider
Low Risk	No XRT
High Risk	XRT

Analysis of collected data to demonstrate that:

Ipsilateral breast recurrence at 3 years is ≤ 6% in DCIS Low Risk patients treated with breast conserving surgery alone, and
Local recurrence rate in DCIS Low Risk patients after treatment with breast conserving surgery alone is not statistically significantly greater than breast cancer recurrences from the DCIS Intermediate and High risk groups receiving radiation

Data analysis described above should be:

Independently verified;
Made public, either in a peer reviewed publication or online, within 1 year of completion.

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Coding Information

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Bibliography

1. Ward EM, DeSantis CE, Lin CC, et al. Cancer Statistics: Breast cancer in situ. CA Cancer J Clin. 2015;65(6):481-495.

2. Zujewski JA, Harlan LC, Morrell DM, et al. Ductal carcinoma in situ: trends in treatment over time in the US. Breast Cancer Res Treat. 2011;127(1):251-257.

3. Correa C, McGale P, Taylor C, et al. Overview of the randomized trials of radiotherapy in ductal carcinoma in situ of the breast. J Natl Cancer Inst Monogr. 2010;(41):162-177.

4. Narod SA, Iqbal J, Giannakeas V, Sopik V, Sun P. Breast cancer mortality after a diagnosis of ductal carcinoma in situ. JAMA Oncol. 2015;1(7):888-896.

5. Baehner FL, Sangli C, Millward C, Cherbavaz D, Goddard A, Shak S. Quantitative gene expression analysis using Oncotype DX in ductal carcinoma in situ that is adjacent to invasive ductal carcinoma. Poster presented: San Antonio Breast Cancer Symposium; December 2008; San Antonio, TX.
6. Baehner FL, Yoshizawa CN, Butler SM, et al. The development of the DCIS Score: scaling and normalization in the Marin Medical Laboratories cohort. Poster presented: ASCO Breast Cancer Symposium; September 2012; San Francisco, CA.

7. Hughes LL, Wang M, Page DL, et al. Local excision alone without irradiation for ductal carcinoma in situ of the breast: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009;27(32):5319-5324.

8. Solin LJ, Gray R, Baehner FL, et al. A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast. J Natl Cancer Inst. 2013;105(10):701-710.

9. Rakovitch E, Nofech-Mozes S, Hanna W, et al. A population-based validation study of the DCIS Score predicting recurrence risk in individuals treated by breast-conserving surgery alone. Breast Cancer Res Treat. 2015;152(2):389-398.

10. Cook NR. Use and misuse of the receiver operating characteristic curve in risk prediction. Circulation 2007;115:928-35.

11. Moons KGM, Harrell FE. Sensitivity and specificity should be de-emphasized in diagnostic accuracy studies. Acad Radiol 2003;10:670-2.

12. Pepe MS, Feng Z, Huang Y, et al. Integrating the predictiveness of a marker with its performance as a classifier. Am J Epidemiology 2008;167:362-8.

13. Alvarado M, Carter DL, Guenther JM, et al. The impact of genomic testing on the recommendation for radiation therapy in patients with ductal carcinoma in situ: A prospective clinical utility assessment of the 12-gene DCIS Score result. J Surg Oncol. 2015;111(8):935-940.

14.Manders JB, Kuerer HM, Smith BD, et al. Clinical utility of the 12-Gene DCIS score assay: impact on radiotherapy recommendations for patients with ductal carcinoma in situ; Ann Surg Oncol. 2017;24:660-668.

15. Young R, Kalnicki S, Fox JL. The DCIS Score - Potential for healthcare savings? Poster presented: San Antonio Breast Cancer Symposium; December 2014; San Antonio, TX.

16. Alvarado MD, Harrison L, Solin LJ, Ozanne EM. Cost-effectiveness of gene expression profiling for DCIS. Poster presented: San Antonio Breast Cancer Symposium; December 2012; San Antonio, TX.

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation	Reasons for Change
09/28/2023	R13	R11 Revision Effective: 09/28/2023 Revision Explanation: Annual review, no changes	Other (Annual Review)
10/06/2022	R12	R11 Revision Effective: 10/06/2022 Revision Explanation: Annual review, no changes	Other (Annual Review)
11/25/2021	R11	R10 Revision Effective: 11/25/2021 Revision Explanation: Under *CMS National Coverage Policy* updated section headings for regulations and added CMS Internet Only Manuals, Pub 100-02 Medicare Beneficiary Policy Manual chapter 15, §80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, §80.1.1 Certification Changes. Under *Bibliography* changes were made to citations to reflect AMA citation guidelines. Formatting and punctuation were corrected throughout the LCD. Acronyms were defined and inserted where appropriate throughout the LCD. Oncotype DX^® was inserted throughout the LCD where applicable.	Provider Education/Guidance
11/28/2019	R10	R9 Revision Effective: n/a Revision Explanation: Annual review, updated contractor's name in Analysis of Evidence section. 10/21/2020:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Other (Annual review)
11/28/2019	R9	R8 Revision Effective: 10/31/2019 Revision Explanation: Annual review conducted, no changes made. 11/21/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Other (Annual Review)
10/31/2019	R8	R8 Revision Effective: 10/31/2019 Revision Explanation: Removed the following regulation from the CMS National Policy section and placed into billing and coding article: Title XVIII of the Social Security Act, §1833(e). Prohibits Medicare payment for any claim which lacks the necessary information to process the claim; CMS On-Line Manual, Publication 100-02, Medicare Benefit Policy Manual,Chapter 15, §§80.0, 80.1.1, 80.2. Clinical Laboratory services; CMS Internet-Only Manuals, Publication 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, 60.1.2 Independent Laboratory Specimen Drawing, 60.2. Travel Allowance; and CMS Internet Online Manual Pub. 100-04 (Medicare Claims Processing Manual), Chapter 23 (Section 10) "Reporting ICD Diagnosis and Procedure Codes". 10/23/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Provider Education/Guidance
09/19/2019	R7	R7 Revision Effective: 09/19/2019 Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901. For Approval, no changes. 09/13/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Revisions Due To Code Removal
09/19/2019	R6	R6 Revision Effective: 09/19/2019 Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901. 09/12/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Revisions Due To Code Removal
08/15/2019	R5	R5 Revision Effective: 08/15/2019 Revision Explanation: Removed all billing and coding details from policy into related Billing and Coding article. Coding information was removed based on CR10901. 08/09/2018-At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Other (Removed billing and coding based on CR10901)
10/01/2018	R4	R4 Revision Effective: 10/01/2018 Revision Explanation:Removed 81479 from CPT/HCPCS Code section and added 0045U to the CPT/HCPCS Code Section. Revision is effective July 1, 2018 and was made per the CPT/HCPCS Q3 Update. The procedure code 0045U will not go into the system until 10/1/18, though claims are retro-effective to 7/1/18. Providers must use 81479 until 10/1/18.	Revisions Due To CPT/HCPCS Code Changes
07/20/2017	R3	Revision#: R3 Revision Effective: N/A Revision Explanation: Annual review no changes made.	Other (Annual review)
07/20/2017	R2	R2 Revision Effective: 07/20/2017 Revision Explanation: Revised policy to add Summary of Evidence, Analysis of Evidence, and Bibliography. There were no changes to coverage. Corrected typographical errors in title.	Typographical Error
03/06/2017	R1	R1 Revision Effective: 03/06/2017 Revision Explanation: Adding D05.12 to group 1 ICD-10 codes as this was left off inadvertently before being released to final.	Typographical Error

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This product includes CPT which is commercial technical data and/or computer data bases and/or commercial computer software and/or commercial computer software documentation, as applicable which were developed exclusively at private expense by the American Medical Association, AMA Plaza, 330 N. Wabash Ave., Suite 39300, Chicago, IL 60611-5885. U.S. Government rights to use, modify, reproduce, release, perform, display, or disclose these technical data and/or computer data bases and/or computer software and/or computer software documentation are subject to the limited rights restrictions of FAR 52.227-14 (December 2007) and/or subject to the restricted rights provisions of FAR 52.227-14 (December 2007) and FAR 52.227-19 (December 2007), as applicable, and any applicable agency FAR Supplements, for non-Department of Defense Federal procurements.

The scope of this license is determined by the AMA, the copyright holder. Any questions pertaining to the license or use of the CPT should be addressed to the AMA. End Users do not act for or on behalf of the CMS. CMS disclaims responsibility for any liability attributable to end user use of the CPT. CMS will not be liable for any claims attributable to any errors, omissions, or other inaccuracies in the information or material contained on this page. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

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Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CDT for resale and/or license, transferring copies of CDT to any party not bound by this agreement, creating any modified or derivative work of CDT, or making any commercial use of CDT. License to use CDT for any use not authorized herein must be obtained through the American Dental Association, 211 East Chicago Avenue, Chicago, IL 60611. Applications are available at the American Dental Association web site, http://www.ADA.org/ http://www.ADA.org/.

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CDT is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. No fee schedules, basic unit, relative values, or related listings are included in CDT. The ADA does not directly or indirectly practice medicine or dispense dental services. The sole responsibility for software, including any CDT and other content contained therein, is with (insert name of applicable entity) or the CMS; and no endorsement by the ADA is intended or implied. The ADA expressly disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice to you if you violate the terms of this Agreement. The ADA is a third-party beneficiary to this Agreement.

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The scope of this license is determined by the ADA, the copyright holder. Any questions pertaining to the license or use of the CDT should be addressed to the ADA. End Users do not act for or on behalf of the CMS. CMS disclaims responsibility for any liability attributable to end user use of the CDT. CMS will not be liable for any claims attributable to any errors, omissions, or other inaccuracies in the information or material covered by this license. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

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License For Use of National Uniform Billing Committee (NUBC) UB-04

These materials contain NUBC Official UB-04 Specifications (UB-04 Data), which is copyrighted by the American Hospital Association (AHA).

THE LICENSE GRANTED HEREIN IS EXPRESSLY CONDITIONED UPON YOUR ACCEPTANCE OF ALL TERMS AND CONDITIONS CONTAINED IN THIS AGREEMENT. BY CLICKING BELOW ON THE BUTTON LABELED "I ACCEPT", YOU HEREBY ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD AND AGREED TO ALL TERMS AND CONDITIONS SET FORTH IN THIS AGREEMENT.

IF YOU DO NOT AGREE WITH ALL TERMS AND CONDITIONS SET FORTH HEREIN, CLICK BELOW ON THE BUTTON LABELED "I DO NOT ACCEPT" AND EXIT FROM THIS COMPUTER SCREEN. IF YOU ARE ACTING ON BEHALF OF AN ORGANIZATION, YOU REPRESENT THAT YOU ARE AUTHORIZED TO ACT ON BEHALF OF SUCH ORGANIZATION AND THAT YOUR ACCEPTANCE OF THE TERMS OF THIS AGREEMENT CREATES A LEGALLY ENFORCEABLE OBLIGATION OF THE ORGANIZATION. AS USED HEREIN, "YOU" AND "YOUR" REFER TO YOU AND ANY ORGANIZATION ON BEHALF OF WHICH YOU ARE ACTING.

Subject to the terms and conditions contained in this Agreement, you, your employees, and agents are authorized to use UB-04 Data only as contained in the following authorized materials and solely for internal use by yourself, employees and agents within your organization within the United States and its territories. Use of UB-04 Data is limited to use in programs administered by Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to ensure that your employees and agents abide by the terms of this Agreement. You acknowledge that the AHA holds all copyright, trademark, and other rights in UB-04 Data. You shall not remove, alter, or obscure any AHA copyright notices or other proprietary rights notices included in the materials.
Any use not authorized herein is prohibited, including, by way of illustration and not by way of limitation, making copies of UB-04 Data for resale and/or license, transferring copies of UB-04 Data to any party not bound by this agreement, creating any modified or derivative work of UB-04 Data, or making any commercial use of UB-04 Data. License to use UB-04 Data for any use not authorized herein must be obtained through the American Hospital Association, 155 N. Wacker Drive, Suite 400, Chicago, Illinois, 60606. Applications are available at the NUBC website, http://www.nubc.org/ http://www.nubc.org/.
The UB-04 Data included in this product is commercial technical data and/or computer databases and/or commercial computer software and/or commercial computer software documentation, as applicable, which was developed exclusively at private expense by the American Hospital Association, 155 N. Wacker Drive, Suite 400, Chicago, Illinois 60606. U.S. Government rights to use, modify, reproduce, release, perform, display, or disclose these technical data and/or computer data bases and/or computer software and/or computer software documentation are subject to the limited rights restrictions of DFARS 252.227-7015(b)(2) (November 1995) and/or subject to the restrictions of DFARS 227.7202-1(a) (June 1995) and DFARS 227.7202-3(a) (June 1995), as applicable for U.S. Department of Defense procurements and the limited rights restrictions of FAR 52.227-14 (December 2007) and FAR 52.227-19 (December 2007), as applicable, and any applicable agency FAR Supplements, for non-Department of Defense Federal procurements.
AHA DISCLAIMER OF WARRANTIES AND LIABILITIES. UB-04 Data is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. The sole responsibility for the software, including any UB-04 Data and other content contained therein, is with the Medicare/Medicaid Contractor or the CMS; and no endorsement by the AHA is intended or implied. The AHA expressly disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice to you if you violate the terms of this Agreement. The AHA is a third-party beneficiary to this Agreement.
CMS DISCLAIMER. The scope of this license is determined by the AHA, the copyright holder. Any questions pertaining to the license or use of the UB-04 Data should be addressed to the AHA. End users do not act for or on behalf of the CMS. CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE UB-04 DATA. CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL COVERED BY THIS LICENSE. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

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MolDX: Oncotype DX® Breast Cancer for DCIS (Genomic Health™)

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