Coverage Policy Manual
Policy #: 2011017
Category: PPACA Preventive
Initiated: September 2010
Last Review: January 2025
  PREVENTIVE SERVICES FOR NON-GRANDFATHERED (PPACA) PLANS: BREAST CANCER PREVENTIVE MEDICATION
Description:
The Federal Patient Protection and Preventive Care Act was passed by Congress and signed into law by the President in March 2010.  The preventive services component of the law became effective 23 September 2010. A component of the law was a requirement that all “non-grandfathered” health insurance plans are required to cover those preventive medicine services given an “A” or “B” recommendation by the U.S. Preventive Services Task Force.  
 
Plans are not required to provide coverage for the preventive services if they are delivered by out-of-network providers.
 
Task Force recommendations are graded on a five-point scale (A-E), reflecting the strength of evidence in support of the intervention.  Grade A: There is good evidence to support the recommendation that the condition be specifically considered in a periodic health examination.  Grade B: There is fair evidence to support the recommendation that the condition be specifically considered in a periodic health examination.  Grade C: There is insufficient evidence to recommend for or against the inclusion of the condition in a periodic health examination, but recommendations may be made on other grounds.  Grade D: There is fair evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.  Grade E: There is good evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.
 
Those preventive medicine services listed as Grade A & B recommendations are covered without cost sharing (i.e., deductible, co-insurance, or co-pay) by Health Plans for appropriate preventive care services provided by an in-network provider.  If the primary purpose for the office visit is for other than Grade A or B USPSTF preventive care services, deductible, co-insurance, or copay may be applied.
 
Policy/
Coverage:
Effective January 2021
 
Chemoprevention counseling by clinicians for women at high risk of breast cancer is covered for members of “non-grandfathered” plans, without cost-sharing (i.e., deductible, co-insurance, or co-pay).
 
The USPSTF recommends that clinicians offer to prescribe risk-reducing medications, such as tamoxifen (effective for members with contracts renewed on or after September 2014, as of the plans date of renewal), raloxifene (effective for members with contracts renewed on or after September 2014, as of the plans date of renewal), or aromatase inhibitors (effective for members with contracts renewed on or after September 2020, as of the plans date of renewal), to women who are at increased risk for breast cancer and at low risk for adverse medication effects. Tamoxifen, raloxifene, and aromatase inhibitors are covered for members of “non-grandfathered” plans, without cost-sharing (i.e., deductible, co-insurance, or co-pay) if all of the following criteria are met:
 
    1. Asymptomatic women aged 35 years of age or older who have not had a previous diagnosis of breast cancer or ductal carcinoma in situ; AND
    2. Have a high risk of breast cancer as determined by a formal breast cancer risk assessment tool (e.g., Breast Cancer Risk Assessment Tool available at www.cancer.gov/bcrisktool) administered by a health care professional; AND
    3. Are at a low risk for adverse effects (e.g., no personal or family history of thromboembolic events)
 
The appropriate ICD-10 codes to report these services are D24.1-D24.9, N60.81- N60.89, Z85.3, Z80.3. Z79.810 or Z15.01.
 
The codes used to report these services include office visits for preventative services (99385-99387 or 99395-99397) and preventive medicine counseling (99401-99404). When the primary purpose of the service is the delivery of an evidence-based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be billed with Modifier ‘-33’. The correct coding as listed for both ICD-10 and CPT or HCPCS codes are also required.
 
There are specific HCPCS codes for billing Tamoxifen (S0187) and for billing aromatase inhibitors Anastrozole (S0170) and Exemestane (S0156).
 
Effective prior to January 2021
The USPSTF recommends that clinicians engage in shared, informed decision making with women who are at increased risk for breast cancer about medications to reduce their risk. Chemoprevention counseling by clinicians for women at high risk of breast cancer is covered for members of “non-grandfathered” plans, without cost-sharing (i.e., deductible, co-insurance, or co-pay).
 
The appropriate ICD-10 codes to report these services are D24.1-D24.9, N60.81- N60.89, Z85.3, Z80.3. Z79.810 or Z15.01.
 
The codes used to report this service include office visits for preventative services, 99385-99387 or 99395-99397,  99401-99404 or HCPCS S0187.  When the primary purpose of the service is the delivery of an evidence-based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be billed with Modifier ‘-33’.  The correct coding as listed for both ICD-10 and CPT or HCPCS codes are also required.
 
Effective for members with contracts renewed on or after September 2014, as of the plans date of renewal, tamoxifen and raloxifene are covered for members of “non-grandfathered” plans, without cost-sharing (i.e., deductible, co-insurance, or co-pay) if all of the following criteria are met:
 
    1. Asymptomatic women aged 35 years of age or older who have not had a previous diagnosis of breast cancer, ductal carcinoma in situ or lobular carcinoma in situ; AND
    2. Have a high risk of breast cancer as determined by a formal breast cancer risk assessment tool (e.g., Breast Cancer Risk Assessment Tool available at www.cancer.gov/bcrisktool)  administered by a health care professional; AND
    3. Are at a low risk for adverse effects (e.g., no personal or family history of thromboembolic events)
 
There is a specific HCPCS code, S0187 to be used for billing Tamoxifen.
 
Effective prior to June 2014
  
Chemoprevention counseling by clinicians for women at high risk of breast cancer and at low risk for adverse effects of chemoprevention is covered for members of “non-grandfathered” plans, without cost-sharing (i.e., deductible, co-insurance, or co-pay).
 
 
The appropriate ICD-9 codes to report these services are 217, 610.8, V16.3 or V84.01
 
The codes used to report this service include office visits for preventative services, 99385-99387 or 99395-99397 or 99401-99404.  When the primary purpose of the service is the delivery of an evidence-based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be billed with Modifier ‘-33’.  The correct coding as listed for both ICD-9 and CPT or HCPCS codes are also required.
 
Rationale:
The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians discuss chemoprevention with women at high risk for breast cancer and at low risk for adverse effects of chemoprevention. Clinicians should inform patients of the potential benefits and harms of chemoprevention (Grade B recommendation).
 
The USPSTF recommendations include the following information:
 
The USPSTF found fair evidence that treatment with tamoxifen can significantly reduce the risk for invasive estrogen-receptor-positive breast cancer in women at high risk for breast cancer and that the likelihood of benefit increases as the risk for breast cancer increases. The USPSTF found consistent but less abundant evidence for the benefit of raloxifene. The USPSTF found good evidence that tamoxifen and raloxifene increase the risk for thromboembolic events (for example, stroke, pulmonary embolism, and deep venous thrombosis) and symptomatic side effects (for example, hot flashes) and that tamoxifen, but not raloxifene, increases the risk for endometrial cancer. The USPSTF concluded that the balance of benefits and harms may be favorable for some high-risk women but will depend on breast cancer risk, risk for potential harms, and individual patient preferences.
 
  • Clinicians should consider both the risk for breast cancer and the risk for adverse effects when identifying women who may be candidates for chemoprevention.
 
Risk for breast cancer. Older age; a family history of breast cancer in a mother, sister, or daughter; and a history of atypical hyperplasia on a breast biopsy are the strongest risk factors for breast cancer.. Other factors that contribute to risk include race, early age at menarche, pregnancy history (nulliparity or older age at first birth), and number of breast biopsies. The risk for developing breast cancer within the next 5 years can be estimated using risk factor information by completing the National Cancer Institute Breast Cancer Risk Tool (the "Gail model," available at http://cancer.gov/bcrisktool/ or 800-4-CANCER). Clinicians can use this information to help individual patients considering tamoxifen therapy estimate the potential benefit. However, the validity, feasibility, and impact of using the Gail model to identify appropriate candidates for chemoprevention has not been tested in a primary care setting. The Gail model does not incorporate estradiol levels or estrogen use, factors that some studies suggest may influence the effectiveness of tamoxifen.
 
Risk for adverse effects. Women are at lower risk for adverse effects from chemoprevention if they are younger; have no predisposition to thromboembolic events such as stroke, pulmonary embolism, or deep venous thrombosis; or do not have a uterus.
 
  • In general, the balance of benefits and harms of chemoprevention is more favorable for:
            1. Women in their 40s who are at increased risk for breast cancer and have no predisposition to thromboembolic events.
            2. Women in their 50s who are at increased risk for breast cancer, have no predisposition to thromboembolic events, and do not have a uterus.
For example, a woman who is 45 years of age and has a mother, sister, or daughter with breast cancer would have approximately a 1.6 percent risk for developing breast cancer over the next 5 years. On average, treating such women with tamoxifen for 5 years would prevent about three times as many invasive cancers (8 per 1,000) as the number of serious thromboembolic complications caused (1 stroke and 1 to 2 pulmonary emboli per 1,000). Among women 55 years of age, benefits exceed harms only for those who are not at risk for endometrial cancer; and the margin of benefit is small unless risk for breast cancer is substantially increased (for example, 4 percent over 5 years).
 
  • Women younger than 40 years of age have a lower risk for breast cancer, and thus will not experience as large an absolute benefit from breast cancer chemoprevention as older women. Women 60 years of age and older, who have the highest risk for breast cancer also have the highest risk for complications from chemoprevention with a less favorable balance of benefits and harms.
 
  • The USPSTF found more evidence for the benefits of tamoxifen than for the benefits of raloxifene. Currently, only tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for the specific indication of breast cancer chemoprevention. Although there are biological reasons to suspect that raloxifene should have similar benefits, trial data currently are limited to one study in which the primary outcome was fracture prevention. Additional trials to further evaluate this drug's efficacy for breast cancer chemoprevention are under way, including a trial comparing efficacy and safety of raloxifene and tamoxifen. Raloxifene is approved by the FDA for preventing and treating osteoporosis.
 
2014 Update
In September 2013, the USPSTF updated the guideline for medications used for risk reduction of breast cancer. The policy has been updated to address this new recommendation.  
 
2021 Update
In September 2019, the USPSTF updated their guidelines to include aromatase inhibitors. The USPSTF recommends that clinicians offer to prescribe risk-reducing medications, such as tamoxifen, raloxifene, or aromatase inhibitors, to women who are at increased risk for breast cancer and at low risk for adverse medication effects.
CPT/HCPCS:
99385Initial comprehensive preventive medicine evaluation and management of an individual including an age and gender appropriate history, examination, counseling/anticipatory guidance/risk factor reduction interventions, and the ordering of laboratory/diagnostic procedures, new patient; 18 39 years
99386Initial comprehensive preventive medicine evaluation and management of an individual including an age and gender appropriate history, examination, counseling/anticipatory guidance/risk factor reduction interventions, and the ordering of laboratory/diagnostic procedures, new patient; 40 64 years
99387Initial comprehensive preventive medicine evaluation and management of an individual including an age and gender appropriate history, examination, counseling/anticipatory guidance/risk factor reduction interventions, and the ordering of laboratory/diagnostic procedures, new patient; 65 years and older
99395Periodic comprehensive preventive medicine reevaluation and management of an individual including an age and gender appropriate history, examination, counseling/anticipatory guidance/risk factor reduction interventions, and the ordering of laboratory/diagnostic procedures, established patient; 18 39 years
99396Periodic comprehensive preventive medicine reevaluation and management of an individual including an age and gender appropriate history, examination, counseling/anticipatory guidance/risk factor reduction interventions, and the ordering of laboratory/diagnostic procedures, established patient; 40 64 years
99397Periodic comprehensive preventive medicine reevaluation and management of an individual including an age and gender appropriate history, examination, counseling/anticipatory guidance/risk factor reduction interventions, and the ordering of laboratory/diagnostic procedures, established patient; 65 years and older
99401Preventive medicine counseling and/or risk factor reduction intervention(s) provided to an individual (separate procedure); approximately 15 minutes
99402Preventive medicine counseling and/or risk factor reduction intervention(s) provided to an individual (separate procedure); approximately 30 minutes
99403Preventive medicine counseling and/or risk factor reduction intervention(s) provided to an individual (separate procedure); approximately 45 minutes
99404Preventive medicine counseling and/or risk factor reduction intervention(s) provided to an individual (separate procedure); approximately 60 minutes
S0156Exemestane, 25 mg
S0170Anastrozole, oral, 1 mg
S0187Tamoxifen citrate, oral, 10 mg
References: Chemoprevention of Breast Cancer, Topic Page. July 2002. U.S. Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/uspstf/uspsbrpv.htm

PPACA & HECRA: Public Laws 111-148 & 111-152. The Patient Protection and Affordable Care Act
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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