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| Medical Policy: | L-96-011 |
| Topic: | Biomarkers in Risk Assessment and Management of Cardiovascular Disease |
| Section: | Laboratory |
| Effective Date: | July 1, 2018 |
| Issue Date: | July 2, 2018 |
| Last Reviewed: | June 2018 |
Numerous lipid and nonlipid biomarkers have been proposed as potential risk markers for cardiovascular disease. This policy will focus on those lipid markers that have the most evidence in support of their use in clinical care. The biomarkers assessed here are apolipoprotein B (apo B), apolipoprotein AI (apo AI), apolipoprotein E (apo E), B-type natriuretic peptide, cystatin C, fibrinogen, high-density lipoprotein (HDL) subclass, leptin, low-density lipoprotein (LDL) subclass, and lipoprotein A. |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Measurement of novel lipid and non-lipid risk factors (i.e., apolipoprotein B, apolipoprotein A-I, apolipoprotein E, B-type natriuretic peptide, cystatin C, leptin, LDL subclass, HDL subclass, lipoprotein[a]) are considered experimental/investigational and, therefore, non-covered, as an adjunct to LDL cholesterol in the risk assessment and management of cardiovascular disease. The available scientific evidence does not provide adequate data to establish that the use of panels that include lipid and non-lipid cardiovascular risk markers improve outcomes when used in clinical care.
The measurement of plasma brain natriuretic peptide (BNP) or NT-proBNP may be medically necessary for ANY ONE of the following indications:
- Differentiating heart failure from pulmonary disease in a dyspneic individual; or
- Monitoring response to treatment for heart failure; or
- Risk stratification in a suspected acute coronary syndrome (ACS).
The measurement of plasma brain natriuretic peptide (BNP) or NT-proBNP testing for any other indication is considered experimental/investigational and, therefore, non-covered. Scientific evidence of safety and efficacy has not been proven.
| Place of Service: Outpatient |
Experimental/Investigational (E/I) services are not covered regardless of place of service.
Brain natriuretic peptide (BNP) testing is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
- Provides free aids and services to people with disabilities to communicate effectively with us, such as:
- Qualified sign language interpreters
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If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
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