CardioChek HDL Cholesterol Control

Insurance Facts

Categorizing our products in the medical marketplace

The CardioChek, our medical diagnostic testing system, can be classified as durable medical equipment (DME). Associated test strips can be classified as disposable medical equipment. As a general rule, when our products are covered under major medical, they are considered DME. If covered under pharmacy benefits, they are considered as drugs or disposables.

Clinical Laboratory Improvement Amendments (CLIA) Waiver

Health care professionals who use the CardioChek medical diagnostic testing system are not subject to CLIA standards as managed by the Health Care Financing Administration. All test methods used by the CardioChek have been classified as being low complexity and are therefore “waived” by the Center For Disease Control, the entity responsible for test categorization.

Coverage for Laboratory Services

There is no evidence of any third party coverage issues for laboratory services provided when using the CardioChek analyzer. Licensed health care professionals should customarily bill using the appropriate Current Procedural Terminology (CPT) codes.

Insurance Billing Options

Public Insurance Billing

Both Medicare and Medicaid view all our products as DME. Claims for Medicare reimbursement should be submitted to one of Medicare’s four Durable Medical Equipment Regional Carriers (DMERC) on HCFA 1500 forms using the appropriate Health Care Financing Administration Common Procedural Coding System (HCPCS) codes.

Private Insurance Billing

Private insurance may provide coverage for our products as part of either pharmacy benefits or major medical. Either national drug codes or HCPCS codes will need to be used. Please check with the individual's particular health plan for the preferred billing method.

Insurance Group Links

• Medicare Coverage Link: www.cms.hhs.gov
• Coding Links : Centers for Medicare & Medicaid Services