Annual Notice to Providers

Dear Valued Client,

As part of Verify Diagnostics DBA Vanta Diagnostics and KorPath (“Verify”) commitment to compliance, transparency, and partnership, we provide this annual notice to our ordering providers. We encourage you to review it carefully. It outlines Verify laboratory’s billing practices, HIPAA policies, and other key compliance matters that are important for your practice. By understanding these policies, you can help ensure accurate claims submission, avoid billing misunderstandings, and maintain alignment with federal and state requirements. We offer several key links to useful and informative information as well. Our goal is to make compliance clear and straightforward, so that you can focus on patient care while we handle testing with integrity and accountability.

Verify Diagnostics is dedicated to ethical business practices and being compliant with the regulations and laws that govern our industry. As always, we realize you have a choice and greatly appreciate and value your trust and confidence in Verify Diagnostic’s family of laboratories.

The Office of Inspector General (“OIG”) recommends clinical laboratories send annual notices to physicians and its clients, to inform them of the laboratory’s policies for test ordering and billing and provide certain other information regarding the laws and regulations that govern laboratory services. This Annual Notice is provided pursuant to that recommendation.

If you have questions about the contents of this notice, please contact the Chief Compliance Officer at compliance@vantadx.com or compliance@korpath.com

LICENSED PHYSICIAN and NON-PHYSICIAN PRACTITIONERS (NPP):
Verify Diagnostics will only accept tests ordered by a licensed physician or other individuals authorized by law to order laboratory tests. If your license has been revoked or suspended, please immediately notify compliance@vantadx.com.

Testing not ordered by licensed, enrolled physicians or other qualified nonphysician practitioners acting within the scope of their practice, and in compliance with Medicare requirements will be denied as not reasonable and necessary in compliance with Medicare requirements.

As of 2014, Medicare requires individuals referring orders for laboratory services on Medicare beneficiaries to be registered in the Center for Medicare and Medicaid Services’ Provider Enrollment, Chain and Ownership System (PECOS) and must have a valid National Provider Identifier (NPI#), available at https://nppes.cms.hhs.gov/NPPES/Welcome.do

Note: Additional information on PECOS and how to enroll in the system may be viewed at: https://pecos.cms.hhs.gov/pecos/login.do#headingLv1

MEDICAL NECESSITY:
As part of Verify Diagnostics’ ongoing commitment to compliance, it is Verify Diagnostics’ policy to ensure its clients understand that they should order only laboratory tests that are medically necessary for their patients. Medicare will only pay for tests that meet Medicare coverage criteria and are medically necessary for the diagnosis or treatment of the individual patient. The medical need for testing must be based on patient-specific elements identified during the clinical assessment and documented by the clinician in the patient’s medical record.

As a participating provider in the Medicare Program, Verify Diagnostics has a responsibility to educate physicians and its clients and to implement test ordering procedures to help ensure all tests requested are performed and billed in a manner consistent with all federal and state law regulations. As the physician, or other provider, you are responsible for ordering tests only when they are medically necessary, for documenting medical necessity in the patient’s permanent medical record, and for providing appropriate diagnostic information in the form of ICD-10 codes to the highest level of specificity or a narrative to Verify Diagnostics. The OIG takes the position that a physician who orders medically unnecessary tests for which Medicare or Medicaid reimbursement is claimed may be subject to civil penalties under the False Claims Act.

MEDICARE NATIONAL AND LOCAL COVERAGE DETERMINATIONS:

The Medicare Program publishes National Coverage Determinations (NCDs) and local Medicare contractors publish Local Coverage Determinations (LCDs) for certain tests. These coverage determinations identify the conditions for which the included tests are or are not covered or reimbursed by Medicare, typically by reference to specific ICD-10 codes that are deemed to support coverage. The coverage determinations are available online at: https://www.cms.gov/medicare-coverage-database/search.aspx

MEDICAL RECORDS:

A payor may request from Verify Diagnostics additional medical records to substantiate the medical necessity of tests Verify Diagnostics performed upon the orders of its clients.

For any service to be covered by Medicare, for example, the patient’s medical record must contain sufficient documentation to support the need for the service, and payors may request medical records to confirm there is such documentation. Documentation should include the specific test(s) ordered, the test methodology, the clinical diagnosis justifying the tests, how the test results will factor into the patient’s care, the treating/ordering provider’s name, and the performing laboratory’s name.

Verify Diagnostics expects its clients to cooperate with Verify Diagnostics’ efforts to obtain requested medical records. In fact, at least with respect to services covered by federal programs, the client’s cooperation is a legal requirement under federal law:

In case of an item or service…ordered by a physician or a practitioner…but furnished by another entity, if the Secretary (or fiscal agent of the Secretary) requires the entity furnishing the item or service to provide diagnostic and or other medical information in order for payment to be made to the entity, the physician or practitioner shall provide that information to the entity at the time that the item or service is ordered by the physician or practitioner.

Section 1842 (p)(4) of the Social Security Act, available at:
https://www.ssa.gov/OP_Home/ssact/title18/1842.htm

TEST ORDERING:
Verify Diagnostics makes its tests available for order by paper test requisition forms, via web-based platforms, and via bi-directional EMR/EHR interfaces. All tests must be ordered by the patient’s treating physician. All test orders must be communicated to Verify Diagnostics in writing or via an approved mode of electronic transmission and must clearly identify the ordering professional, the test(s) to be performed, the source of the specimen (when appropriate), the patient’s unique name and unique identifiers (gender, DOB, SSN, address), insurance details, diagnosis code(s) and ordering provider signature.

It is a condition of Medicare coverage that each order for testing billed under the Clinical Laboratory Fee Schedule be signed by the authorized person who ordered the test or be supported by signed documentation in the medical record. Rubber stamps, pre-printed signatures or letterheads are not acceptable, unless a limited exception applies.

If Verify Diagnostics receives a test order on a non-Verify Diagnostics requisition form or on a Verify Diagnostics requisition form that is not completely filled out, processing of your test order may be delayed. As necessary, Verify Diagnostics will contact physicians to have them complete a missing information form with the required information or otherwise clarify each specific test being ordered. Only tests that are ordered will be reported. We do not accept backdated test requisitions. Everything delayed or requiring clarification must be reconciled via the missing information form.

TEST GROUPS:
The use of non-patient-specific panels, custom profiles or test groups is discouraged. If a client wishes to establish a custom profile or test group, the client must understand:

• A provider should order only those tests which the provider believes are medically necessary for each patient. Medically necessary testing should be based on individual patient specific elements identified during the clinical assessment and documented by the clinician in the patient’s medical record.
• Using a custom profile may result in the ordering of tests for which Government or private third-party payors will deny payment of tests that are not covered or deemed reasonable or necessary;
• The provider should order only individual tests or a less inclusive profile when not all the tests in the custom profile are medically necessary for each individual patient;
• The provider should thoroughly review all tests included in their test groups or profiles and make changes in the appropriate system(s), at any time; and
• The OIG takes the position that a provider who orders medically unnecessary tests may be subject to civil and criminal penalties.

VERBAL TEST ORDERS:

Medicare regulations require that all orders for laboratory tests be in writing. If a physician or their authorized representative orders a test by phone or wishes to add a test to an existing order, a written order is required to support the verbal order. In these cases, Verify Diagnostics will send confirmation of the verbal order request to the ordering physician, requesting the missing information form to be signed and sent back to the laboratory for its records.

Testing will not be performed until the missing information form is returned to the laboratory.

ADVANCE BENEFICIARY NOTICE OF NONCOVERAGE:
Not all laboratory services are covered by Medicare. For statutorily excluded services, laboratories may bill Medicare patients directly. For certain other laboratory tests, an advance beneficiary notice of noncoverage is used to document that the patient has been made aware that Medicare may not pay for services and has agreed to pay the laboratory in the event payment is denied. Key reasons for requesting an ABN are based on medical necessity, service limitations, or investigational or experimental services. Verify Diagnostics may ask clients to secure signed advance beneficiary notices of noncoverage from patients before Verify Diagnostics performs tests that may be denied payment by Medicare.

Information on ABN’s is available at: https://www.cms.gov/medicare/forms-notices/beneficiary-notices-initiative/ffs-abn

PATIENT PRIVACY (HIPAA):

Under the Health Insurance Portability and Accountability Act (HIPAA), Verify Diagnostics is a health care provider and a covered entity. It is our policy to fully comply with the HIPAA privacy and security standards. Our Notice of Privacy Practices is available on the Verify Diagnostics website, https://www.vantadiagnostics.com/

INDUCEMENTS:

Federal law prohibits offering or paying any remuneration – meaning anything of value – to induce or reward the referral of tests that are covered by Medicare, Medicaid or other federal health care programs.

Any form of kickback, payment or other remuneration that is intended to secure the referral of federal health care program testing business is strictly prohibited and should be reported to the Verify Diagnostics Compliance Hotline at (833) 827-3804, through the reporting website at vantadx.ethicspoint.com, or directly to Verify Diagnostics Chief Compliance Officer at compliance@vantadx.com

PROHIBITED REFERRALS:
It is the policy of Verify Diagnostics to comply with all aspects of the laws and regulations governing referrals for testing services, including the federal Stark Law, the federal Anti-Kickback Statute, and the federal Eliminating Kickbacks in Recovery Act. Under the Stark Law, for example, if a financial relationship exists between a physician (or an immediate family member) and a laboratory, and the relationship does not fit into one of the law’s exceptions, then (a) the physician may not refer Medicare patients to the laboratory, and (b) the laboratory may not bill Medicare for services referred by the physician.

MEDICARE AND MEDICAID REIMBURSEMENT FOR LAB SERVICES:

Laboratory services billed to Medicare are paid based on a fee schedule. The Medicare fee schedule for lab services is available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched

Medicaid reimbursement will be equal to or less than the amount of Medicare reimbursement.

CLINICAL CONSULTANT:
Verify Diagnostics clinical consultant/Medical Affairs can be reached at (854) 429-1069. Additionally, Verify Diagnostics offers PharmD guidance as part of our offerings.

FINANCIAL ASSISTANCE PROGRAMS:
Verify Diagnostics encourages its clients to direct patients who are financially unable to pay for Verify Diagnostics testing services to contact (854) 444-7317, who will work with the patient to determine their eligibility for Verify Diagnostics financial assistance program.

COMMUNICATION:
Client agrees that all laboratory tests must be authorized by the physician who is treating the beneficiary. The client may assign an authorized designee to deliver the clinical laboratory order; however, the client attests that any designee will only have the authority to deliver the order as directed by the treating practitioner.

CMS defines an order as a communication from the treating physician/practitioner requesting that a diagnostic test be performed for a beneficiary. Although CMS does not require the order to be signed by the physician, the treating (ordering) physician must clearly document in the beneficiary’s record the intent to order the diagnostic test and document the medical necessity supporting the ordered service.