Provider and pharmacist FAQ

RIGHTMED comprehensive test

The RightMed comprehensive test is a provider-ordered pharmacogenomic test that covers hundreds of medications that treat a wide range of medical conditions, including psychiatric conditions, cancer, chronic pain, cardiovascular disease, and more. It analyzes a large set of genes that have been shown, based on OneOme’s rigorous research and standards for inclusion, to affect how a patient metabolizes many commonly prescribed medications.

The RightMed test includes sample collection through either a buccal (cheek) swab kit or a blood sample, pharmacogenomic testing services, data analysis, clinical interpretation, the RightMed comprehensive test report, the RIGHTMED ADVISOR, and several reporting options. In addition, OneOme has clinical pharmacists and client service representatives available to answer your questions. Learn more about the RightMed test.

The test covers hundreds of medications. View the full MEDICATION LIST.

View our GENE LIST to see our a list of genes covered on the OneOme RightMed test.

OneOme recognizes that there are differing opinions on MTHFR. Because of this, OneOme gives providers the option to choose whether or not to order MTHFR.

For providers interested in MTHFR, it can be added at no additional cost when ordering the RightMed comprehensive test. MTHFR results will be provided on a separate report containing analytical results only (which means medications are not classified on it). MTHFR is also available as a standalone single gene test. Please note that MTHFR is not available to patients purchasing the test online directly from OneOme; their provider must place an order for them and add MTHFR. View our SAMPLE MTHFR TEST REPORT.

For providers who are not interested in receiving MTHFR results, please note it is not included with the RightMed comprehensive test unless it is actively selected as an add-on test.

The RightMed Advisor is an interactive tool that helps make pharmacogenomic test results actionable for providers. With the RightMed Advisor, providers can quickly and easily interpret test results, access OneOme’s expertly curated pharmacogenomic database, view pharmacogenomic clinical guidelines, evaluate drug-to-drug interactions, explore alternative medications, generate custom reports, and more.

No. In fact, we are committed to providing intuitive tools for providers to use to make pharmacogenomic test results actionable. We also have clinical pharmacists on staff that are available for consultations to review results and answer your questions.

SINGLE GENE TESTS

Providers can order a test for a specific, single gene. Like the RightMed test, our single gene tests include testing services and data analysis. Unlike the RightMed test, the single gene test results are provided in an analytical report only — they do not include medication classification or clinical guidelines. LEARN MORE

We currently offer single gene tests for CYP2C19, DPYD, MTHFR, and UGT1A1.

ORDERING OUR TESTS

Our tests can be ordered several ways. Including by:

1) Filling out and returning a TEST REQUISITION FORM
2) Creating a PROVIDER PORTAL ACCOUNT and placing an order
3) Requesting a TEST KIT and returning the kit and test requisition form

For more information, please CONTACT US.

In the United States, unless a pharmacist has a collaborative practice agreement in place, he or she cannot order any of our tests. In certain countries (like Canada), pharmacists can order our tests. Even though pharmacists usually cannot order our tests, OneOme strongly believes that pharmacists play a critical role in pharmacogenomics. Visit our PHARMACIST PAGE to learn more.

OneOme offers its tests in all U.S. states and in select international locations. Please CONTACT US for more information on availability within your area.

In most cases OneOme pays for both the shipping of the DNA test kit to the patient’s home and the return shipping to the OneOme laboratory.

Note: OneOme does not cover international return shipping.

Our sample collection kit meets the FedEx packaging guidelines for clinical samples. This includes a watertight plastic tube for collection of the sample, which is placed in a watertight bio-specimen bag, which is then placed in a FedEx Clinical Pak for return shipment.

For additional details please view our SAMPLE REQUIREMENTS.

OneOme retains DNA samples for up to 60 days from the date the report was released for purposes of quality assurance and/or to conduct follow up testing as requested by the provider.

OneOme reserves the right to cancel an order when any of the following occurs:

  1. OneOme does not receive a sample within 45 days of the sample's collection date or of the kit's delivery date
  2. OneOme does not receive payment within 45 days of the order date (for patient self-pay orders)
  3. OneOme does not receive required information within 45 days of the order date
RESULTS & REPORTS

OneOme’s turnaround time is up to 10 days from receipt of sample.

View a sample RIGHTMED COMPREHENSIVE REPORT to see how test results are displayed. Additional sample reports are also available, including RIGHTMED ADVISOR CUSTOM REPORTS, the RIGHTMED PSYCHIATRY REPORT, and the RIGHTMED ONCOLOGY REPORT.

The RightMed specialty reports are optional reports, each including a subset of medications selected and classified by OneOme for use in the treatment of specific specialty areas (currently available are the RIGHTMED PSYCHIATRY REPORT and the RIGHTMED ONCOLOGY REPORT). Providers must order the RightMed comprehensive test but can choose to receive the speciality reports in addition to the RightMed comprehensive test report at no extra charge. All medications featured on the speciality reports are also on the comprehensive test report. The specialty reports can be requested at the time of order or once the test results are available from the report center.

When ordering the RightMed comprehensive test, you can select medications that are most relevant to you and your patient. Results for those selected medications will be summarized in the RightMed comprehensive test report, and a RightMed Advisor report will also be generated with more in-depth information including clinical annotations, dosing guidelines, and medication alternatives. You may also create a report after you have received the test results, by using our RightMed Advisor to generate a RightMed Advisor report. View a sample RIGHTMED ADVISOR REPORT.

View a sample CYP2C19 REPORT, DPYD REPORT, MTHFR REPORT, or UGT1A1 REPORT to see how test results are displayed. Each single gene offered is also included in or available as a complimentary add-on to the RightMed comprehensive test. View a RIGHTMED COMPREHENSIVE TEST REPORT.

As a matter of practice, OneOme routinely updates its pharmacogenomics database as new information becomes available to the scientific community. Medication classifications and annotations found on the patient’s “regenerated” report are based on the latest version of OneOme’s database. The “regenerated” report may have additional medications that have been found to meet OneOme’s rigorous level of evidence since the original report was generated, or may have medications and/or genes removed that no longer meet OneOme’s criteria for inclusion.

Many factors could lead to an update in the reporting of a gene-drug interaction, including:

  • Changes in the way we interpret how certain variants impact the expression or function of a gene based on scientific updates available to us (e.g., allele function score).
  • The number of genes or weight of impact of the genes associated with a medication may be updated based on new scientific information.
  • New evidence may become available on the phenotype impact on a medication, such as professional guideline creation, FDA label update, or newly published clinical studies.

While infrequent, OneOme sometimes adds new genes or alleles (alternative form of the same gene/genetic locus) to the RightMed comprehensive test. If you would like your patient to have newly added genes or alleles included in their report, a new order must be created and they must be tested again.

OneOme regularly adds new medications to the RightMed comprehensive test. OneOme automatically regenerates a patient’s report at no extra cost to include new medications, assuming the genes and alleles associated with the medications were on our panel when the patient was tested.

If, however, the genes and alleles associated with the new medications were not on our panel when the patient was tested, they will not be included on regenerated reports. If you would like your patient to have newly added medications included in their report, a new order must be created and they must be tested again.

BILLING

We offer a self-pay option for $349 (U.S. only). Additionally, we offer insurance (U.S. only) and institutional billing. When billing to insurance or an institution, the price may vary. LEARN MORE about the cost of the RightMed test.

We offer a self-pay option for $199 per single gene test (U.S. only). Additionally, we offer insurance (U.S. only) and institutional billing. When billing to insurance or an institution, the price may vary. LEARN MORE about the cost of our tests.

At OneOme, our goal is to provide every patient with access to our tests at the lowest price point available. That’s why we’ve created a billing process that supports multiple payment options including:

  • Patient self-pay (U.S. only)
  • Institutional billing
  • Insurance billing (U.S. only)

LEARN MORE about our billing options.

Yes, insurance billing is available to all U.S. customers. Insurance billing can be selected as the billing option at the time of order on either our test requisition form or when ordering through OneOme’s provider portal. LEARN MORE about insurance billing.

The test requisition form (TRF) indicates the information needed for insurance billing. The billing section on the right-hand side of the page must be completed in its entirety before testing can begin. This includes additional information such as insurance information and reason(s) for testing. Payer-specific criteria are available on our BILLING PAGE.

Preauthorization does not guarantee payment. Insurance companies determine how much they will pay and what charges will be billed to the patient after a medical claim is filed. The patient is responsible for any portion of the test fee not covered by the insurance company for any reason including, but not limited to, copayments, co-insurance, unmet deductibles, or non-covered services.

Note: The patient is responsible for remitting any funds received directly from the insurance company to OneOme.

It is the responsibility of the submitting party to determine the correct CPT codes to use when filing billing claims to third-party insurance. A list of relevant codes is available on our BILLING PAGE.

OneOme accepts all Medicare, Medicaid, and TRICARE plans. If your patient has a traditional Medicare/Medicaid plan, Managed Medicaid Plan, or TRICARE, their cost will be $0. Medicare Advantage Plans may have a co-payment or deductible requirement.

We require a signed letter of medical necessity for traditional Medicare claims prior to testing.

Yes, OneOme provides the option to invoice the institution or provider directly. View our BILLING PAGE for more information.

Payment is due 30 days from the date of the invoice. Please CONTACT US to discuss payment plans, if necessary.

Yes, for patients in the U.S. Our patient self-pay price is $349 for the RightMed comprehensive test and $199 per single gene test. Payment can be made by credit card, health savings account (HSA), or Paypal. We also offer interest-free payment plans.

Yes, we require payment before the test is processed in our lab.

The date of service (DOS) on the invoice is the date of sample collection. We won’t bill for services until the report has been sent to the ordering healthcare provider.

OneOme’s Tax Identification Number is 46-4356584.

SCIENCE AND CLINICAL DEVELOPMENT

Drugs with professional guidelines from Clinical Pharmacogenetics Implementation Consortium (CPIC), Dutch Pharmacogenetics Working Group (DPWG), and the U.S. Food and Drug Administration (FDA) that are specific for a given drug-genotype or drug-phenotype relationship are assigned the highest priority for inclusion on the RightMed test. OneOme also curates and includes other medications for which metabolism has either been characterized with data on drug-to-drug interactions involving a gene, or the preponderance of scientific evidence demonstrates a clinical outcome associated with a genetic variant.

Yes, the RightMed comprehensive test includes several genes that are involved in the CYP450 pathway. OneOme also offers a single gene test for CYP2C19, which is one of the genes that is involved in that pathway.

OneOme leverages PCR-based (polymerase chain reaction) methods for our genotyping and copy number variant analysis.

The RightMed comprehensive test, database, and reports were developed by utilizing complex multi-gene algorithms co-developed and exclusively licensed from leading pharmacogenomic experts at Mayo Clinic—Dr. John Black, Dr. Richard Weinshilboum, and Dr. Liewei Wang—on a rigorously tested genotyping technology platform.

We start by curating a list of medications based on available clinical evidence from scientific literature and public and private databases (such as PharmGKB and Lexicomp). This information is summarized and reviewed by our medical and scientific team of experts in pharmacology, bioinformatics, and genetics. Through this rigorous review, only medications meeting an exacting level of evidence, as determined by the experts, are included in the database.

The “level of evidence” refers to the strength of scientific data supporting the association between a drug and a pharmacogene. OneOme’s classification scheme follows elements of the system developed by PHARMGKB, which classifies drugs on a scale of 1 to 4. Drugs with level 1 evidence have published practice guidelines for the use of genotyping and/or FDA package insert guidance for genotyping. These drugs have the most clinically actionable data and are noted on the report if applicable to the particular genotype or phenotype combination for that patient. Drugs with level 2 evidence have published clinical evidence of high quality that supports genotyping, but they do not have published specific practice guidelines. OneOme only includes drugs which fit within the definition of level 1 or level 2 as described above.

Based on the patient’s genotype and the algorithmic analysis, the final report shows a list of drugs classified by level of gene-drug interaction in a simple-to-use format: red (major gene-drug interaction), yellow (moderate gene-drug interaction), or green (minimal gene-drug interaction).

OneOme’s licenses and certifications are available for reference and download on our LICENSING PAGE.

Technical support

OneOme’s online tools are best accessed using the most up to date web browser for your device with Chrome as the preferred browser for the optimal experience.

OneOme supports the following versions for each browser:

  • Chrome 50 or greater
  • Firefox 45 or greater
  • Safari 9.1 or greater
  • Edge 38 or greater
  • Internet Explorer 10 or 11

OneOme’s online tools are best accessed using the most up to date web browser for your device with Chrome as the preferred browser for the optimal experience.

OneOme supports the following versions for each browser:

  • Chrome 50 or greater
  • Firefox 45 or greater
  • Safari 9.1 or greater
  • Edge 38 or greater
  • Internet Explorer 10 or 11

View OneOme’s PRIVACY POLICY. In general, except as described in our privacy policy, we do not disclose HIPAA-protected patient information to third parties without the patient’s consent.