Annual Notice to Providers

Annual Laboratory Compliance Notice to Health Care Providers and Professionals

This notice is being issued in accordance with guidance issued by the Office of Inspector General (OIG) in the U.S. Department of Health and Human Services (DHHS). The OIG recommends that a clinical diagnostic laboratory communicate the following information to healthcare providers and professionals.

Medical Necessity

The Centers for Medicare & Medicaid Service (CMS) advises that Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury (and within the scope of a Medicare benefit category). Further, to support a determination that a laboratory diagnostic test is reasonable and necessary, adequate documentation must be available to demonstrate a health care professional’s order and the medical necessity of the diagnostic tests.

CMS and the Medicare payment contractors (MACs) issue National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) to set forth the standards for establishing that a item or service is reasonable and necessary.

If a particular test ordered for a patient will likely not be covered as it does not meet Medicare NCD or LCD medical necessity guidelines, the patient should be provided with an Advance Beneficiary Notice (ABN). Providing the prescribed CMS ABN advises the patient of her/his potential financial responsibility for a diagnostic test if Medicare denies coverage and payment.

Requirements for Medicare Coverage of Diagnostic Laboratory Services

In order for diagnostic laboratory services to be covered by Medicare, they must meet specified regulatory specifications.

Certain diagnostic laboratory tests have been classified into panels for coding and coverage purposes. Any grouping of laboratory tests that is not described in the Organ and Disease Panel section of the AMA CPT Manual is considered to be a customized profile. Ordering a customized profile of tests may result in Medicare denial of coverage of one or more of those tests that are not considered to be reasonable and necessary.

Medicare Payments

    Medicare payment for covered diagnostic laboratory tests is made on the basis of an established fee schedule.

    A summary of tests performed by HealthtrackRx with related CPT/HCPCS Codes and National Fee Limits is set forth in Attachment 1. Also, as stated by the OIG, “the Medicaid reimbursement amount will be equal to or less than the amount of Medicare reimbursement.”

    Clinical Consultant

    Consistent with the requirements of the Clinical Laboratory Improvement Act (CLIA), HealthtrackRx ha a clinical consultant who is available to address ordering, coverage, and other clinical information to health care providers and professionals:

    Patient Privacy

    HealthtrackRx is a “covered entity” subject to the Privacy and Security Rules issued under the Health Insurance Portability and Accountability Act (HIPAA). HealthtrackRx is committed to safeguarding “protected health information,” and only releasing it as authorized under HIPAA. The HealthtrackRx HIPAA Privacy Officer may be reached at: 940-383-2223


    HealthtrackRx is committed to being fully compliant with all applicable Federal, State, and local laws and regulations. It has a comprehensive compliance program that follows the guidance set forth by the DHHS OIG. Further, it encourages the reporting of any compliance related concerns, issues, or questions. The Compliance Team may be reached at [email protected]

    In addition, HealthtrackRx has a Compliance Hotline, administered by and independent vendor, for the confidential reporting of any compliance issues, which may be anonymous if preferred.

    The toll-free Hotline Number is: 844-990-0002.

    Emails may be sent to: [email protected]

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