Coverage Policy Manual
Policy #: 2011010
Category: PPACA Preventive
Initiated: September 2010
Last Review: April 2022
  PREVENTIVE SERVICES FOR NON-GRANDFATHERED (PPACA) PLANS: SERUM LIPIDS SCREENING AND STATIN USE FOR THE PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE

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.
 
Additionally, the law requires coverage of Bright Futures recommendations for children from the American Academy of Pediatrics, preventive services for women outlined by the Health Resources and Services Administration’s (HRSA’s) Women’s Preventive Services: Required Health Plan Coverage Guidelines and all vaccinations recommended by the Advisory Committee for Immunization Practices (ACIP) of the Centers for Disease Control and Prevention.
 
Bright Futures was established by the Health and Human Services (HHS) Health Resources and Services Administration’s Maternal and Child Health Bureau with the mission to “promote and improve the health, education, and wellbeing of infants, children, adolescents, families and communities” (AAP, 2008). Bright Futures describes its guidelines as “evidence informed rather than fully evidence driven” (Hagan, 2008). Unlike the USPSTF, Bright Futures does not assign grades to recommendations that do not definitively recommend for or against a particular preventive service. Rather than leave gaps in the recommendations, Bright Futures supplements evidence with experience and expert opinion to ensure that definitive guidance is given (IOM, 2011).
 
 

Policy/
Coverage:
EFFECTIVE APRIL 2021
1.) Screening for serum lipids (total cholesterol and HDL cholesterol) is covered for members of “non-grandfathered” plans on an annual basis, without cost-sharing (i.e., deductible, co-insurance, or co-pay):
 
        • for adults age 40 to 75 years
        • for children who test positive on risk screening questions at age 2, 4, 6 and 8 years
        • once for children between the ages of 9 and 11
        • once for adolescents between the ages of 17 and 21
        • for adolescents who test positive on risk screening questions between 12 and 16 years
 
The appropriate ICD-10 codes to report these services are Z00.8, Z00.121, Z00.129 or Z13.220
 
Codes that may be used to report the cholesterol and HDL cholesterol are CPT 80061, 82465, and/or 83718. 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.
 
 
2.) The use of a low- to moderate-dose statin for the prevention of cardiovascular disease (CVD) events and mortality is covered for members of “non-grandfathered” plans, without cost sharing (i.e., deductible, co-insurance or co-pay) when all of the following criteria are met:
 
        • Member is between 40 to 75 years of age AND
        • Member has 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking) AND
        • Member has a calculated 10-year risk of a cardiovascular event of 10% or greater.
 
Note: Statins addressed in this policy are available through the pharmacy benefit and are not covered under the medical benefit.
 
EFFECTIVE PRIOR TO APRIL 2021
Screening for serum lipids (total cholesterol and HDL cholesterol) is covered for members of “non-grandfathered” plans on an annual basis, without cost-sharing (i.e., deductible, co-insurance, or co-pay)
 
  • for men 35 and over;  
  • for men ages 20 – 34 who are at increased risk for coronary heart disease (“increased risk” defined in the Rationale);
  • for women 20 and older if they are at increased risk of coronary heart disease (increased risk” defined in the Rationale);
  • for children who test positive on risk screening questions beginning at age 2. If risk factors change, repeat screening can be done at 4 years, 6 years, 8 years, between 9 and 11 years, 12-17 years, and between 18 and 21 years. (Bright Futures Recommendation) (Change Effective 4/13/2016)
 
The appropriate ICD-9 codes to report these services are  V20.2, V70.0, V70.9 or V77.91.   
 
The appropriate ICD-10 codes to report these services are Z00.8, Z00.121, Z00.129 or Z13.220
 
Codes that may be used to report the cholesterol and HDL cholesterol are CPT 80061, 82465, and/or 83718.  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) strongly recommends screening men aged 35 and older for lipid disorders (Grade A recommendation).
 
The USPSTF strongly recommends screening women aged 45 and older for lipid disorders if they are at increased risk for coronary heart disease  (Grade: A Recommendation).
 
The USPSTF recommends screening men aged 20 to 35 for lipid disorders if they are at increased risk for coronary heart disease (Grade B recommendation).
 
The USPSTF recommends screening women aged 20 to 45 for lipid disorders if they are at increased risk for coronary heart disease (Grade B recommendation).
 
 The USPSTF recommendations include the following information:
    • Lipid disorders, also called dyslipidemias, are abnormalities of lipoprotein metabolism and include  levations of total cholesterol, LDL-C, or triglycerides (TG), or deficiencies of HDL-C. These disorders can be acquired or familial (e.g., familial hypercholesterolemia). This recommendation applies to adults aged 20 and older who have not previously been diagnosed with dyslipidemia.
    • Increased risk, for the purposes of this recommendation, is defined by the presence of any one of the risk factors listed below. The greatest risk for CHD is conferred by a combination of multiple listed factors. While the USPSTF did not use a specific numerical risk to bound this recommendation, the framework used by the USPSTF in making these recommendations relies on a 10-year risk of cardiovascular events:1
        • Diabetes.
        • Previous personal history of CHD or non-coronary atherosclerosis (e.g., abdominal aortic aneurysm, peripheral artery disease, carotid artery stenosis).
        • A family history of cardiovascular disease before age 50 in male relatives or age 60 in female relatives.
        • Tobacco use.
        • Hypertension.
        • Obesity (BMI >30).
    • The preferred screening tests for dyslipidemia are total cholesterol and HDL-C on non-fasting or fasting samples. There is currently insufficient evidence of the benefit of including TG as a part of the initial tests used to screen routinely for dyslipidemia. Abnormal screening test results should be confirmed by a repeated sample on a separate occasion, and the average of both results should be used for risk assessment.
    • Measuring total cholesterol alone is acceptable for screening if available laboratory services cannot provide reliable measurements of HDL-C; measuring both total cholesterol and HDL-C is more sensitive and specific for assessing coronary heart disease risk than measuring total cholesterol alone. In conjunction with HDL-C, the addition of either LDL-C or total cholesterol would provide comparable information, but measuring LDL-C requires a fasting sample and is more expensive. Direct LDL-C testing, which does not require a fasting sample measurement, is now available; however, calculated LDL (total cholesterol minus HDL minus TG/5) is the validated measurement used in trials for risk assessment and treatment decisions. In patients with dyslipidemia identified by screening, complete lipoprotein analysis is useful.
    • The optimal interval for screening is uncertain. On the basis of other guidelines and expert opinion, reasonable options include every 5 years, shorter intervals for people who have lipid levels close to those warranting therapy, and longer intervals for those not at increased risk who have had repeatedly normal lipid levels.
    • An age to stop screening has not been established. Screening may be appropriate in older people who have never been screened; repeated screening is less important in older people because lipid levels are less likely to increase after age 65. However, because older adults have an increased baseline risk for coronary heart disease, they stand to gain greater absolute benefit from the treatment of dyslipidemia, compared with younger adults.
    • Treatment decisions should take into account a person's overall risk of heart disease rather than lipid levels alone. Overall risk assessment should include the presence and severity of the following risk factors: age, gender, diabetes, elevated blood pressure, family history (in younger adults), and smoking. Risk calculators that incorporate specific information on multiple risk factors provide a more accurate estimation of cardiovascular risk than tools that simply count numbers of risk factors.1
    • Drug therapy is usually more effective than diet alone in improving lipid profiles, but choice of treatment should consider overall risk, costs of treatment, and patient preferences. Guidelines for treating lipid disorders are available from the National Cholesterol Education Program of the National Institutes of Health (http://www.nhlbi.nih.gov/about/ncep/).
    • Although lifestyle modifications (diet and physical activity) are appropriate initial therapies for most patients, a minority achieves substantial reductions in lipid levels from changes in diet alone; drugs are frequently needed to achieve therapeutic goals, especially for those at increased risk for coronary heart disease. Lipid-lowering treatments should be accompanied by interventions addressing all modifiable risk factors for heart disease, including smoking cessation, treatment of blood pressure, diabetes, and obesity, as well as promotion of a healthy diet and regular physical activity. Long-term adherence to therapies should be emphasized.
 
The Third Edition of Bright Futures: Guidelines for Health Supervision of Infants, Children and  Adolescents recommends selective screening for dyslipidemia; using risk screening questions at  each well-child visit (Hagan, 2008).  A serum lipid profile should be conducting for positive  responses to risk assessment questions.  A serum lipid profile test should be conducted once  during adolescence for all patients regardless of the responses to the selective screening.
 
Medical History Risk Factors include:
        • Consume excessive saturated fats
        • Elevated Blood Pressure
        • Diabetes
        • Physical Inactivity
        • Renal Disease
        • Body Mass Index at or above the 85th percentile
        • Unobtainable history or any factors for coronary artery disease.
        • Risk assessment questions may include:
            • Does the child have parents or grandparents who have had a stroke or heart problem before age 55?
            • Does the child have a parent with elevated blood cholesterol (240mg/dl or higher) or who is taking cholesterol medication?
 
2021 Update
Cardiovascular disease is a broad term that encompasses a number of atherosclerotic conditions that affect the heart and blood vessels, including coronary heart disease, as ultimately manifested by myocardial infarction (MI), and cerebrovascular disease, as ultimately manifested by stroke. Cardiovascular disease is the leading cause of morbidity and mortality in the United States, accounting for 1 of every 3 deaths among adults (Mensah, 2007).
 
Statins are a class of lipid-lowering medications that function by inhibiting the enzyme 3-hydroxy-3-methyl-glutaryl coenzyme A reductase, which is involved in the rate-limiting step in the production of cholesterol. Statins reduce levels of total cholesterol and LDL-C and, to a lesser extent, triglycerides, and probably have anti-inflammatory and plaque stabilization effects as well (Chou, 2016).
 
The USPSTF found adequate evidence that use of low- to moderate-dose statins reduces the probability of CVD events (MI or ischemic stroke) and mortality by at least a moderate amount in adults aged 40 to 75 years who have 1 or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 10% or greater.
 
The USPSTF found adequate evidence that use of low- to moderate-dose statins reduces the probability of CVD events and mortality by at least a small amount in adults aged 40 to 75 years who have 1 or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 7.5% to 10%.
 
The USPSTF found inadequate evidence to conclude whether initiating statin use in adults 76 years and older who are not already taking a statin is beneficial in reducing the incidence of CVD events and mortality.
 
The USPSTF found adequate evidence that the harms of low- to moderate-dose statin use in adults aged 40 to 75 years are small. Randomized, clinical trials (RCTs) of statin use for the primary prevention of CVD events have largely used low and moderate doses; under these conditions, statin use was not associated with serious adverse events such as cancer, severely elevated liver enzyme levels, or severe muscle-related harms. However, evidence concerning the association between statin use and diabetes mellitus is mixed, with 1 prevention trial suggesting that there may be a small increased risk of developing diabetes with use of high-dose statins. Myalgia is a commonly reported adverse effect of statins, but placebo-controlled trial data do not support the conclusion that statin use has a major causative role in its occurrence. Evidence for cognitive harms is relatively sparse; further research would be needed to more definitively establish the relationship between statin use and cognitive function. The USPSTF found no clear evidence of decreased cognitive function associated with statin use. These findings are consistent with those from a recent systematic review of RCTs and observational studies assessing the effect of statins on cognition that found no effect on incidence of Alzheimer disease or dementia (Richardson, 2013). The recently published HOPE-3 (Heart Outcomes Prevention Evaluation 3) trial found that statin use increased risk of cataract surgery, which was unanticipated and not a predetermined outcome of the trial (Yusuf, 2016). None of the other primary prevention trials reported this outcome (Chou, 2016).
 
The USPSTF found inadequate evidence on the harms of statin use for the prevention of CVD events in adults 76 years and older without a history of heart attack or stroke.
 
The USPSTF concludes with moderate certainty that initiating use of low- to moderate-dose statins for the prevention of CVD events and mortality in adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 10% or greater has at least a moderate net benefit.
 
The USPSTF concludes with moderate certainty that initiating use of low- to moderate-dose statins for the prevention of CVD events and mortality in adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 7.5% to 10% has a small net benefit. The decision to initiate therapy in this population should reflect an assessment of patients’ specific circumstances and their preference for a potential small benefit relative to the potential harms and inconvenience of taking a lifelong daily medication.
 
The USPSTF concludes that the evidence is insufficient to determine the balance of benefits and harms of initiating statin use for the primary prevention of CVD events and mortality in adults 76 years and older without a history of CVD.
 
This recommendation replaces the USPSTF 2008 recommendation on screening for lipid disorders in adults. When making a recommendation on a preventive medication, the USPSTF uses the systematic evidence review to determine how to identify persons in the general population for whom the USPSTF can be moderately certain about the balance of benefits and harms of a preventive medication on health outcomes.
 
Accumulating evidence on the role of statins in preventing CVD events across different populations led the USPSTF to reframe its main clinical question from "which population should be screened for dyslipidemia?" to "which population should be prescribed statin therapy?" Screening for elevated lipid levels is a necessary (but not sufficient) step in the overall assessment of CVD risk to help identify persons who may benefit from statin therapy. In the age range in which statins have been studied for primary prevention, universal screening for elevated lipid levels is required to make this determination. Therefore, the screening framework used in the previous USPSTF recommendation statement is no longer relevant and has been replaced by a preventive medication framework. This recommendation statement focuses on the assessment of overall CVD risk to identify adults aged 40 to 75 years without a history of CVD who will benefit most from statin use to reduce their risk of experiencing a CVD event. The USPSTF found no studies that evaluated the effects of statin use on health outcomes in disease-free adults younger than 40 years. The research plan that guided the evidence review, which served as the foundation of this recommendation statement, did not consider reduction in LDL-C level to be a sufficient surrogate for health outcomes.

CPT/HCPCS:
80061Lipid panel This panel must include the following: Cholesterol, serum, total (82465) Lipoprotein, direct measurement, high density cholesterol (HDL cholesterol) (83718) Triglycerides (84478)
82465Cholesterol, serum or whole blood, total
83718Lipoprotein, direct measurement; high density cholesterol (HDL cholesterol)

References: Chou R, Dana T, Blazina I, Daeges M, Jeanne T.(2016) Statins for prevention of cardiovascular disease in adults: a systematic review and meta-analysis for the US Preventive Services Task Force. JAMA. 2016. doi: 10.1001/jama.2015.15629

Chou R, Dana T, Blazina I, et al.(2016) Statin Use for the Prevention of Cardiovascular Disease in Adults: A Systematic Review for the US Preventive Services Task Force. Evidence Synthesis No. 139. AHRQ Publication No. 14-05206-EF-2. Rockville, MD: Agency for Healthcare Research and Quality; 2016.

Hagan JF, Shwa JS, Duncan PM, eds.(2008) Bright Futures: Guidelines for health supervision of infants, children and adolescents, 3rd ed. Elk Grove Village, IL: American Academy of Pediatrics.

IOM (Institute of Medicine).(2011) Clinical Preventive Services for Women: Closing the Gaps. Washington, DC: The National Acadamies Press.

Mensah GA, Brown DW.(2007) An overview of cardiovascular disease burden in the United States. Health Aff (Millwood). 2007;26(1):38-48.

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

Richardson K, Schoen M, French B, et al.(2013) Statins and cognitive function: a systematic review. Ann Intern Med. 2013;159(10):688-97.

Screening for lipid disorders in adults. U.S. Preventive Services Task Force http://www.uspreventiveservicestaskforce.org/uspstf/uspschol.htm

US Preventive Services Task Force (USPSTF).(2016) Final Recommendation Statement Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication. November 13, 2016. United States Preventive Services Taskforce (uspreventiveservicestaskforce.org). Accessed 4/16/2021.

Yusuf S, Bosch J, Dagenais G, et al; HOPE-3 Investigators.(2016) Cholesterol lowering in intermediate-risk persons without cardiovascular disease. N Engl J Med. 2016;374(21):2021-31.


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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