Coverage Policy Manual
Policy #: 2011013
Category: PPACA Preventive
Initiated: September 2010
Last Review: July 2018
  PREVENTIVE SERVICES FOR NON-GRANDFATHERED (PPACA) PLANS: ASPIRIN TO PREVENT CARDIOVASCULAR DISEASE AND COLORECTAL CANCER IN ADULTS

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 JULY 2017
 
Counseling for the initiation of  low-dose aspirin for the primary prevention of cardiovascular disease (CVD) and colorectal cancer (CRC) is covered for the following members of “non-grandfathered” plans, without cost-sharing (i.e., deductible, co-insurance, or co-pay):
 
    • adults aged 50 to 59 years who have a 10% or greater 10-year CVD risk;  AND
    • are not at increased risk for bleeding;  AND
    • have a life expectancy of at least 10 years;  AND
    • are willing to take low-dose aspirin daily for at least 10 years.  
 
Over the counter aspirin supplementation is not covered.
 
The appropriate ICD-9 code to report these services is V70.0 or V70.9.
 
The appropriate ICD-10 codes to report these services include Z00.00-Z00.01 or Z00.8.
  
This service is included as part of a preventative office visit, codes 99386-99387, 99396-99397 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.
 
EFFECTIVE PRIOR TO JULY 2017
Counseling for the use of aspirin is covered for members of “non-grandfathered” plans, without cost-sharing (i.e., deductible, co-insurance, or co-pay):
 
    • in men 45-79 years when the potential benefit due to a reduction in myocardial infarctions outweighs the potential harm due to an increase in gastrointestinal hemorrhage;
 
    • in women 55-79 years when the potential benefit of a reduction in ischemic strokes outweighs the potential harm of an increase in gastrointestinal hemorrhage;
 
The appropriate ICD-9 code to report these services is V70.0 or V70.9.
 
The appropriate ICD-10 codes to report these services include Z00.00-Z00.01 or Z00.8.
  
This service is included as part of a preventative office visit, codes 99386-99387, 99396-99397 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 the use of aspirin:
 
    • in men 45-79 years when the potential benefit due to a reduction in myocardial infarctions outweighs the potential harm due to an increase in gastrointestinal hemorrhage(Grade A recommendation).
 
    • in women 55-79 years when the potential benefit of a reduction in ischemic strokes outweighs the potential harm of an increase in gastrointestinal hemorrhage (Grade A recommendation).
 
 The USPSTF recommendations include the following information:
 
 Men  
The net benefit of aspirin depends on the initial risk for coronary heart disease events and gastrointestinal bleeding.  Thus, decisions about aspirin therapy should consider the overall risks for coronary heart disease and gastrointestinal bleeding.
 
Risk assessment for coronary heart disease should include ascertainment of risk factors: age, diabetes, total cholesterol levels, high-density lipoprotein cholesterol levels, blood pressure, and smoking. Available tools provide estimations of coronary heart disease risk (such as the calculator available at http://hp2010.nhlbihin.net/atpiii/calculator.asp).
 
The estimated number of myocardial infarctions prevented by aspirin use according to coronary heart disease risk level for men age 45 to 79 years can be estimated from available data ((http://www.uspreventiveservicestaskforce.org/uspstf09/aspirincvd/aspcvdrsf2.htm ). It also shows that the coronary heart disease risk level at which the absolute number of myocardial infarctions prevented by the use of aspirin is greater than the absolute number of gastrointestinal bleeding episodes and hemorrhagic strokes caused by aspirin therapy increases with age. The estimates (http://www.uspreventiveservicestaskforce.org/uspstf09/aspirincvd/aspcvdrsf3.htm) were developed assuming that the men are not currently taking nonsteroidal anti-inflammatory drugs (NSAIDs) and are without other conditions that increase the risk for gastrointestinal bleeding (see below). Furthermore, the decision about the exact level of risk at which the potential benefits outweigh potential harms is an individual one. Some men may decide that avoiding a myocardial infarction is of great value and that having a gastrointestinal bleeding event is not a major problem. This group would probably decide to take aspirin at a lower coronary heart disease risk level than men who are more afraid of gastrointestinal bleeding. Men who have a high likelihood of benefiting with little potential for harm should be encouraged to consider aspirin. Conversely, aspirin use should be discouraged among men who have little potential of benefiting from the therapy or have a high risk for gastrointestinal bleeding.
 
Shared decision making should be encouraged with men for whom the potential benefits and risks for serious bleeding are more closely balanced. This discussion should explore the potential benefits and harms and patient preferences. As the potential benefit increases above potential harms, the recommendation to take aspirin should become stronger.
 
Evidence on the benefits in men younger than 45 years is limited, and the potential benefit in this age group is probably low because the risk for myocardial infarction is very low.
 
Women
The net benefit of aspirin depends on the initial risks for stroke and gastrointestinal bleeding. Thus, decisions about aspirin therapy should consider the overall risk for stroke and gastrointestinal bleeding.
 
Risk factors for stroke include age, high blood pressure, diabetes, smoking, a history of cardiovascular disease, atrial fibrillation, and left ventricular hypertrophy. Tools for estimation of stroke risk are available (such as the calculator available at http://www.westernstroke.org/PersonalStrokeRisk1.xls).
 
The estimated number of strokes prevented by aspirin use according to stroke risk level in women age 55 to 79 years can be estimated by available data (http://www.uspreventiveservicestaskforce.org/uspstf09/aspirincvd/aspcvdrsf4.htm  ). It also shows that the stroke risk level at which the absolute number of strokes prevented is greater than the absolute number of gastrointestinal bleeding events caused increases with age. The estimates        (http://www.uspreventiveservicestaskforce.org/uspstf09/aspirincvd/aspcvdrsf3.htm) were developed assuming that women are not currently taking NSAIDs and are without other conditions that increase the risk for gastrointestinal bleeding. Furthermore, the decision about the exact stroke risk level at which the potential benefits outweigh harms is an individual one. Some women may decide that avoiding a stroke is of great value but experiencing a gastrointestinal bleeding event is not a major problem. These women would probably decide to take aspirin at a lower stroke risk level than those who are more afraid of a bleeding event. Women who have little potential of benefiting from aspirin therapy or have a high risk for gastrointestinal bleeding should be discouraged from taking aspirin.
 
Shared decision making should be encouraged with women for whom the potential benefits and risks for serious bleeding are more closely balanced. This discussion should explore potential benefits and harms and patient preferences. As the potential stroke reduction benefit increases above the potential harms, the recommendation to take aspirin should become stronger.
 
Evidence on benefits in women younger than 55 years is limited, and the potential benefit in this age group is probably low because the risk for stroke is very low.
 
Gastrointestinal Bleeding
Evidence shows that the risk for gastrointestinal bleeding with and without aspirin use increases with age.  For the purposes of making this recommendation, the USPSTF considered age and sex to be the most important risk factors for gastrointestinal bleeding. Other risk factors for bleeding include upper gastrointestinal tract pain, gastrointestinal ulcers, and NSAID use. Nonsteroidal anti-inflammatory drug therapy combined with aspirin approximately quadruples the risk for serious gastrointestinal bleeding compared with the risk with aspirin alone. The rate of serious bleeding in aspirin users is approximately 2 to 3 times greater in patients with a history of a gastrointestinal ulcer. Men have twice the risk for serious gastrointestinal bleeding than women.  These risk factors increase the risk for bleeding substantially and should be considered in the overall decision about the balance of benefits and harms of aspirin therapy. Enteric-coated or buffered preparations do not clearly reduce the adverse gastrointestinal effects of aspirin. Uncontrolled hypertension and concomitant use of anticoagulants also increase the risk for serious bleeding.
 
The optimum dose of aspirin for preventing cardiovascular disease events is not known. Primary prevention trials have demonstrated benefits with various regimens, including dosages of 75 and 100 mg/d and 100 and 325 mg every other day. A dosage of approximately 75 mg/d seems as effective as higher dosages. The risk for gastrointestinal bleeding may increase with dose.
 
2017 Update
The recommendation for aspirin use to prevent cardiovascular disease was revised in April 2016 (Bibbins-Domingo, 2016). The following is a summary of the recommendation.
    • The magnitude of the health benefits of aspirin use depends on an individual’s baseline CVD risk and willingness to take aspirin for a sufficient duration to obtain the benefit of reduced incidence of CRC. The magnitude of harms depends on the presence of risk factors for bleeding.
    • The magnitude of the cardiovascular risk reduction with aspirin use depends on an individual’s initial risk for CVD events. Risk assessment for CVD should include ascertainment of the following risk factors: age, sex, race/ethnicity, total cholesterol level, high-density lipoprotein cholesterol level, systolic blood pressure, hypertension treatment, diabetes, and smoking. An online version of the ACC/AHA risk calculator can be found at http://tools.acc.org/ASCVD-Risk-Estimator/This link goes offsite. Click to read the external link disclaimer.
    • Colorectal cancer prevention plays an important role in the overall health benefit of aspirin, but this benefit is not apparent until 10 years after aspirin therapy is started. Patients need to take aspirin for at least 5 to 10 years to realize this potential benefit, and persons with shorter life expectancy are less likely to benefit. Thus, aspirin use is more likely to have an effect when it is started between the ages of 50 and 59 years. Because of the time required before a reduced incidence in CRC is seen, older persons (that is, 60 years or older) are less likely to realize this benefit than adults aged 50 to 59 years.
    • Evidence shows that risk for GI bleeding, with and without aspirin use, increases with age. For this recommendation, the USPSTF considered older age and male sex to be important risk factors for GI bleeding. Other risk factors include upper GI tract pain, GI ulcers, concurrent anticoagulation or NSAID use, and uncontrolled hypertension. Nonsteroidal anti-inflammatory drug therapy combined with aspirin use increases the risk for serious GI bleeding compared with aspirin use alone. The rate of serious bleeding among aspirin users is about 2 to 3 times greater in patients with a history of GI ulcer. The risk for serious GI bleeding is 2 times greater in men than in women. These risk factors increase the risk for bleeding substantially and should be considered in the overall decision about whether to start or continue aspirin therapy. There is no evidence that enteric-coated or buffered formulations reduce the risk for serious GI bleeding.
    • Overall, the USPSTF determined that the greatest net benefit to be gained is by adults aged 50 to 59 years whose 10-year CVD risk is 10% or greater. The USPSTF recommends that persons in this age and risk group start taking aspirin. Adults aged 60 to 69 years may also benefit from starting aspirin use, although the net benefit is smaller due to the increased risk for GI bleeding and decreased benefit in CRC prevention in this age group.
    • Further, the decision about the level of CVD risk at which the potential benefits outweigh potential harms is an individual one. Some adults may decide that avoiding an MI or a stroke is very important and that having a GI bleeding event is not as significant. They may decide to take aspirin at a lower CVD risk level than those who are more concerned about GI bleeding. Adults who have a high likelihood of benefit with little potential for harm should be encouraged to consider aspirin use. Conversely, adults who have little potential for benefit or are at high risk for GI bleeding should be discouraged from it.
    • The optimal dose of aspirin to prevent CVD events is not known. Primary prevention trials have demonstrated benefits with various regimens, including doses of 75 and 100 mg per day and 100 and 325 mg every other day. A dose of 75 mg per day seems as effective as higher doses. The risk for GI bleeding may increase with the dosage. A pragmatic approach consistent with the evidence is to prescribe 81 mg per day, which is the most commonly prescribed dose in the United States.
    • Although the optimal timing and frequency of discussions about aspirin therapy are unknown, a reasonable approach may be to assess CVD and bleeding risk factors starting at age 50 years and periodically thereafter, as well as when CVD and bleeding risk factors are first detected or change.
    • Evidence from primary prevention trials on the benefits of initiating aspirin use in adults younger than 50 years is limited. The potential benefit is probably lower than in adults aged 50 to 69 years because the risk for CVD events is lower (only a small percentage of adults younger than 50 years have a 10-year CVD risk ≥10%). Adults younger than 50 years who have an increased 10-year CVD risk may gain significant benefit from aspirin use; how much benefit is uncertain.
    • Evidence on the benefits and harms of initiating aspirin use in older adults is limited. Many adults aged 70 years or older are at increased risk for CVD because of their age. They have a high incidence of MI and stroke; thus, the potential benefit of aspirin could be substantial.
    • The relationship between older age and GI bleeding is well-established; thus, the potential harms for adults older than 70 years are significant. The complexity of risk factors, medication use, and concomitant illness make it difficult to assess the balance of benefits and harms of initiating aspirin use in this age group. In addition, aspirin use in adults older than 70 years results in smaller reductions in the incidence of CRC compared with younger adults. 
    • Nearly 40% of U.S. adults older than 50 years use aspirin for the primary or secondary prevention of CVD. A study of National Health and Nutrition Examination Survey data assessed how common aspirin use is for the primary prevention of CVD and whether physicians recommend it or patients start it on their own. Among patients who were eligible for aspirin therapy and were at increased CHD risk (>10% 10-year risk), about 41% were told by a physician to take aspirin. Among patients aged 65 years or older who were told by a physician to take aspirin, 80% adhered to the recommendation.  

CPT/HCPCS:
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
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

References: Kirsten Bibbins-Domingo, PhD, MD, MAS, on behalf of the U.S. Preventive Services Task Force.(2016) Aspirin Use for the Primary Prevention of Cardiovascular Disease and Colorectal Cancer: Ann Intern Med. 2016;164(12):836-845.

PPACA & HECRA: Public Laws 111-148 & 111-152. The Patient Protection and Affordable Care Act

U.S. Preventive Services Task Force. Aspirin for the Prevention of Cardiovascular Disease: Recommendation Statement. AHRQ Publication No. 09-05129-EF-2, March 2009. http://www.uspreventiveservicestaskforce.org/uspstf09/aspirincvd/aspcvdrs.htm


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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