Medicare Guidelines

Medicare Program Definitions

Genova Diagnostics is a Medicare participating provider and submits claims directly to Medicare on behalf of patients. Claims can only be filed for medically necessary services ordered by a healthcare practitioner who is authorized to order and refer laboratory testing, and who has enrolled in the PECOS database.

Please review the various types of Medicare coverage listed below to identify the option that best describes the patient´s coverage.

For detailed billing information related to the medicare programs, simply scroll down to the applicable option. For detailed program information please scroll down to Government Payer Guidelines section below.

Medicare. If the patient´s only form of insurance is Medicare, please refer to our Medicare FAQs for more coverage details. However, if a patient has Medicare AND/OR an additional form of insurance coverage, please review and select the appropriate coverage option from the other options listed below. Patients who use Medicare as primary coverage should NOT use our EasyPay program. No upfront payment is required when Medicare is the patient´s primary coverage.

Medicare Advantage. If the patient has Medicare Advantage — the form of Medicare coverage that is administered by private insurance companies such as Blue Cross and Blue Shield, Aetna, etc., he/she should utilize our EasyPay billing option, for more information click here .

Medicare as Secondary Insurance. If the patient uses Medicare as secondary insurance after a claim has been filed with his/her primary insurance for remaining costs for services have been determined as Patient Responsibility. Patients who use Medicare as secondary coverage should NOT use our EasyPay program. No upfront payment is required when Medicare is the patient´s secondary coverage.

Medicare Supplements. Medicare Supplements are a form of secondary insurance that work in conjunction with Medicare to cover patient out of pocket costs. Patients with Medicare supplements have Medicare as primary and should see the Medicare section above.

Medicaid. Genova Diagnostics files Medicaid claims in a select number of states. Please see the Medicaid section of this page for details about which states we file in.

Tricare or CHAMPUS. For patients insured through a Tricare or CHAMPUS insurance carrier, Genova Diagnostics will directly file a claim on their behalf to your insurance provider. Patients who utilize Tricare or CHAMPUS coverage should NOT use our EasyPay Program. Please note that no upfront payment amount is required for patients who are covered by either Tricare or CHAMPUS.

General Medicare FAQs

Genova Diagnostics will file claims directly to Medicare on behalf of patients as long as the following conditions are met:

  1. The test is deemed medically necessary.
  2. The health care practitioner has a valid National Provider Identifier (NPI).
  3. STOP AND READ: If the health care practitioner is not authorized to order or refer laboratory services, according to Medicare program guidelines, the patient will be financially responsible for all charges.

  4. 3. A completed requisition form is received with valid ICD-9 (ICD-10 on or after 10/01/2015) diagnosis coding and a copy of the patient´s Medicare card.

Medicare does not cover laboratory services unless they are ordered by health care practitioners with specific credentials AND are considered diagnostic and medically-necessary by Medicare. When these conditions are not met, Medicare may assign the cost of services as "Patient Responsibility". In this case, Schedule B of our EasyPay insurance billing program is recommended. Medicare patients may choose our EasyPay Schedule B option and/or will be financially responsible when:

  1. Receiving services from a health care practitioner who is not authorized to order or refer laboratory services according to Medicare program guidelines; For qualified degree types, please read the next question, "Who is authorized to order laboratory testing".
  2. The test is likely to be denied coverage by Medicare and the patient selects option two on his/her Advanced Beneficiary Notice (ABN); For more information please see "Who is authorized to order laboratory testing" below.
  3. The test is determined by Medicare as a screening test or a test statutorily not covered.

Medicare only allows health care practitioners with certain credentials to order and refer services for Medicare patients. The table below shows degree types that are commonly considered as either authorized or not authorized.

Selected Qualified Degrees AUTHORIZED to Order and Refer Laboratory Services for Medicare Patients – (must be enrolled in PECOS).
MD, DO, DMD, DDS, DPM, OD, A, NP, CNM, CNS, CSW, PsyD, Medical Interns, Residents, Fellows

For more information on PECOS, and opt-out affidavit, please see http://www.gdx.net/billing/pecos
Selected Common Degrees NOT AUTHORIZED to Order and Refer Lab Services for Medicare Patients
DC, ND, LAC, DOM, CNN

For complete information on authorized providers please visit the CMS web site:
www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/SE1221.pdf

Medicare Compliance

Genova Diagnostics has taken a proactive role in Medicare Compliance. We fully support federal regulations to enforce financial and professional integrity, which means that we are committed to ensuring that tests ordered for Medicare reimbursement meet the standards of "medical necessity."

All claims submitted to Medicare for Genova Diagnostics testing must be medically necessary. Thus, tests performed for screening purposes will NOT be reimbursed by the Medicare program.

Please note that Medicare does not cover services that health care practitioners order for themselves or family members; practitioners may choose our client billing option or contact their Sales Representative for more information.

Medicare requires a physician signature to validate orders for laboratory services. Signatures maybe either electronic or hand written, must be legible, and must be date-stamped. This physician signature must be provided in one of the following ways:

  1. Written as part of the health care practitioner´s medical record.
  2. Included in progress notes, provided that the specific test(s) are indicated in the notes.
  3. A legibly signed test requisition form.
  4. By filling out a Medicare Signature form, the Medicare Signature form is kept on file and serves as a standing physician signature authorization. In order to prevent requests for medical records and attestation statements, print a copy of a Medicare Signature Form to complete, legibly sign, and fax or mail to us.

Other information regarding the signature requirement:

  1. A signature log may be used to validate a handwrittren signature.
  2. An attestation statement can be used in the event an order is documented in the medical record, but there is no signature or date. In order to prevent requests for medical records and attestation statements, print a copy of a Medicare Signature Form to complete, legibly sign, and fax or mail to us.

Please contact our Billing office at 1-800-201-8333 option 2 for more information on documenting orders for Medicarepatients/beneficiaries.

Government Payer Guidelines

Medicare only covers services defined as medically necessary for the diagnosis and treatment of patients. Tests performed for screening purposes are neither eligible for coverage nor reimbursable by Medicare. In some instances, it is acceptable for physicians to order a single test or a portion of a test in order to meet the Medicare medical guidelines.

Patients may choose to have their Medicare coverage administered through a commercial insurance company, such as Blue Cross and Blue Shield, Aetna, etc. This type of Medicare coverage is called Medicare Advantage. The patient will still have a traditional Medicare card, but he/she will also have a commercial insurance card from the administrating insurance company. These commercial insurance cards will most likely indicate Medicare Advantage coverage with terms like, but not limited to, "Medicare," "MedAdv," "MA," "Senior," or "Gold."

Medicare Advantage claims are processed through our EasyPay insurance billing program. The plan provider (insurance company) will determine whether the patient should use EasyPay Schedule A or EasyPay Schedule B*. Please see the EasyPay Schedule B list below for Medicare Advantage administrators that are subject to Schedule B pricing. Patients with plans from all other Medicare Advantage providers NOT listed on the EasyPay Schedule B list below are eligible for EasyPay Schedule A. Please see the EasyPay Schedule A guidelines by clicking here.

Schedule B Insurance Companies (Medicare Advantage admins, where applicable)

  • Aetna
  • Humana
  • Principal
  • Kaiser
  • Tufts
  • Blue Cross Blue Shield (BCBS) of North Carolina
  • Horizon BCBS of New Jersey

*PLEASE NOTE: Some Medicare Advantage plans assign substantial out-of-pocket expenses to patients for Genova Diagnostics´ services. Medicare Advantage patients who are covered by an insurance provider listed under EasyPay Schedule B should take this into consideration when receiving services from Genova Diagnostics, especially those services that will most likely result in substantial out-of-pocket expenses.

BE CAREFUL not to confuse Medicare Secondary OR Supplements plans with Medicare Advantage plans. Medicare Advantage plans are in lieu of Medicare while Medicare Supplements are in conjunction with traditional Medicare.

Below are examples of Medicare Advantage Insurance cards:

Note: Schedule A and B above refer to EasyPay Schedule A and EasyPay Schedule B. For more information on our EasyPay program, please click here.

Medicare Secondary insurance refers to cases where the patient´s primary insurance coverage is through a commercial insurance company and Medicare is used to cover any remaining balance that the commercial insurance company has determined as "Patient Responsibility." Medicare Secondary claims are filed separately, AFTER the patient´s claim has been filed with his/her primary (commercial) insurance. If a Medicare patient indicates that he/she has commercial insurance, in addition to Medicare, it is important to verify whether he/she has commercial insurance as primary or secondary coverage, OR as a Medicare Advantage plan. If the patient´s commercial insurance coverage is primary or secondary to Medicare, please provide a photocopy of both the Medicare card AND the commercial insurance card and write "primary" or "secondary" under each card and DO NOT utilize our EasyPay program. Please include the copy of the insurance cards with your test kit.

Medicare Supplements typically state "Medicare Supplement" clearly on the patient´s card. In the case of Medicare Supplements, Medicare is the primary insurance and, similar to Medicare Secondary, a supplemental claim is filed once the Medicare claim has been filed and benefits have been determined. If there is a Medicare Supplement card, please provide a photocopy of both the Medicare card AND the Medicare Supplement insurance card and DO NOT utilize our EasyPay program. Please include the copy of the insurance cards with your test kit.

Below is an example of a Medicare Supplement card:

Example of a Medicare Supplement Insurance card

Genova Diagnostics only files claims with Medicaid programs in the following states:

  • North Carolina
  • Minnesota
  • Oregon

In the states listed above, health care practitioners must be authorized to order or refer laboratory services according to Medicaid program guidelines.

Medicaid patients may choose our EasyPay Schedule B – No Insurance Billing option if they are receiving testing services in any other state not listed above.

Here is an example of a Medicaid card:

For patients insured through a Tricare or CHAMPUS insurance carrier, Genova Diagnostics will directly file a claim on your behalf to your insurance provider.  Patients who utilize Tricare or CHAMPUS coverage should NOT use our EasyPay Program. Please note that no upfront payment amount is required for patients who are covered by either Tricare or CHAMPUS. 

Below are examples of Tricare and CHAMPUS cards.

The Medicare program requires that patients be given a form called an Advanced Beneficiary Notice(ABN) for certain tests. ABNs are included with applicable test kits and should be reviewed carefully by the patient.

Tests that may be eligible for Limited Coverage and will only be covered when a patient´s symptoms support medical necessity; in this instance, Genova Diagnostics includes an ABN with relevant test kits. For a detailed listing of tests requiring an ABN, please see Limited Coverage Test Requiring ABN section below.

  • Please note: Statutorily Non-Covered (No ABN Required) are tests with no possibility of coverage by Medicare. In this instance, Genova Diagnostics includes a Notice of Medicare Non-Coverage with relevant test kits. Please see the Statutorily Non – Covered section below for more information.
ABNs are mandated by Medicare to:

  1. Advise patients that a test may not be covered by Medicare (also referred to as informed consent).
  2. Allow patients, with informed consent, to authorize a lab to perform a given test and file a Medicare claim.
  3. Allow patients to make payment at a discounted rate to minimize out-of-pocket expense and without having a claim filed with Medicare.
  4. Give patients the opportunity, with informed consent, to acknowledge that claims not covered by Medicare will become his/her financially responsibility.

An ABN must be obtained prior to submitting the patient´s test sample/specimen. To be completed properly, the ABN must:

  • have the patient/beneficiary´s name indicated at the top of the form
  • must have an option selected with a check or "x"
  • must be signed and dated by the patient
  • be sent with the test requisition and test sample/specimen
  • Please note: Medicare regulations require the covered party to be given a copy of the signed ABN by the health care practitioner´s office.

PLEASE NOTE:

  • Below is a list of tests within certain profiles that are subject to national and/or local Medicare Coverage Policies, and therefore coverage is limited to specific conditions.
  • Tests requiring ABNs may or may not be covered by Medicare. See module "Limited Coverage Tests Requiring ABN" for a list of the tests that require ABNs.
  • ABNs notify the patient, in advance, of the specific test components that may not be covered, as well as estimated amounts for which he/she may be billed once a completed ABN is submitted with the test kit.

The tests listed on the table below are subject to limited coverage and include an Advanced Beneficiary Notice (ABN) in each test kit. The tests in the left column may be eligible for Medicare coverage; however a portion of the test may be ineligible (as indicated in the right hand column).

Profiles with ABN Notice in Kit Portion of Profile that may or may not be covered – ABN notice is specific to this test
NutraEval® Vitamin D Assay
Bone Resorption Assessment Collagen Crosslinks
Cardiovascular Profiles:
  • CV Health
  • CV Health Plus Genomics
  • Comprehensive Cardiovascular
  • Homocysteine Assay
  • Fibrinogen
  • C-Reactive Protein, HS
Comprehensive Thyroid Assessment
  • Throxine
  • Free Thyroid Stimulating Hormone
PreD Guide™
  • C-Reactive Protein, HS
  • Hemoglobin, Glycated
  • Glucose
MetSyn Guide™
  • C-Reactive Protein, HS
  • Hemoglobin, Glycated
  • Glucose
Perspective™
  • C-Reactive Protein, HS
  • Vitamin D Assay
  • Glucose
ONE™ Optimal Nutritional Evaluation - Plasma Vitamin D Assay
Hormonal Health Vitamin D Assay
Vitamin D Vitamin D Assay
Male Hormonal Health Vitamin D Assay

Certain Genova Diagnostics tests are NOT covered by Medicare and do not require an Advanced Beneficiary Notice (ABN). Genova Diagnostics provides a Notice of Medicare Non-Coverage for these profiles to notify the patient that these services will not be covered by Medicare and that they will be financially responsible for the services. In this instance Genova Diagnostics includes an ABN with relevant kits. Please see our full list of Non-Covered Services.

Genova Diagnostics Medicare Notice Listing for Kits

Statutorily Non-Covered Services Notice needed:

Product

Test

Gastrointestinal/immunology

0075 Allergix® IgG4 Food Antibodies Profile 90

All

0076 Allergix® Bloodspot IgG4 Food Antibodies Profile 30

All

0270 Allergix® IgE Food Antibodies Profile

All

Nutritional

0090 ION® Profile

All

190 ION® NY Profile

All

0490 ION® with Amino Acids 40 Profile

All

0590 ION® with Amino Acids NY

All

0290 Cardio/ION™ Profile

All

0390 Cardio/ION™ Profile NY

All

0091 Organix® Comprehensive Profile

All

0391 Organix® Comprehensive Profile NY

All

0097 Organix® Dysbiosis Profile

All

0397 Organix® Compounds of Microbial Origin Profile NY

All

0291 Organix® Basic Profile (w/o Dysbiosis Markers)

All

3291 Organix® Basic Profile NY

All

0400 TRIAD™ Profile

All

0410 TRIAD™ Bloodspot Profile

All

0010 Amino Acids 40 Profile

All

0310 Amino Acids 40 Profile NY

All

0011 Amino Acids 20 Profile

All

0311 Amino Acids 20 Profile NY

All

0013 Bloodspot™ Amino Acids 11 Profile

All

0113 Bloodspot™ Amino Acids 20 Profile

All

0041 Fatty Acids - Erythrocytes

All

0341 Fatty Acids NY - Erythrocytes

All

0040 Fatty Acids Profile - Plasma

All

0340 Fatty Acids NY - Plasma

All

0241 Bloodspot Fatty Acids Profile

All

0036 Fat-Soluble Vitamins Profile

All

0031 Vitamin K Assay

All

0033 Coenzyme Q10 Plus Vitamins

All

0161 Cardiovascualar Health Profile

All

0088 Neopterin/Biopterin Profile

All

0022 Nutrient & Toxic Elements Profile - Blood

All

0020 Nutrient & Toxic Elements Profile - Hair

All

Any test/profile assoc. with Chelation / Medicare doesn't cover anything related to any service related to Chelation Therapy.

All

Endocrinology

0142 Estronex® Profile

All

0145 Estronex® with Bone Resorption Profile

All

Genomics

CardioGenomics®

All

ImmunoGenomics®

All

OsteoGenomics®

All

NeuroGenomicsPlus®

All

EstroGenomics

All

Environmental

1765 Toxic Effects CORE™ Profile

All

0060 Porphyrins Profile

All

0740 Phthalates & Parabens Profile

All

0760 Chlorinated Pesticies Profile

All

0761 CBs Profile

All

0762 Volatile Solvents Profile

All

0763 Organophosphates Profile

All

0764 Bisphenol A (BPA) Profile

All

1760 CP, PCBs Profile

All

1761 CP, PCB, Volatile Solvents Profile

All

1763 BPA, Phthalates & Parabens, OP Profile

All

1764 BPA, Phthalates & Parabens Profile

All

How Can We Help?

© 1998 - 2015 Genova Diagnostics (GDX)
This website is intended for educational purposes only. It is not meant for use as diagnostic information and is part of Genova Diagnostics' communication with physicians and patients.