Caris - Life Science

Main Menu
MENU
  • Patients
    • Fighting Cancer Smarter
      • What is a Biomarker?
    • Patient Stories
    • Find a Physician
    • Share Your Story
    • Financial Services
    • Pay Your Bill
  • Products & Services
    • Molecular Profiling
      • Blood Profiling
      • Tissue Profiling
      • Testing Menu
      • Profiling Technologies
        • Whole Exome (DNA)
          • Homologous Recombination Deficiency
          • Genomic Loss of Heterozygosity
          • Microsatellite Instability
          • Tumor Mutational Burden
          • Human Leukocyte Antigen
        • Whole Transcriptome (RNA)
      • ORDER
    • Artificial Intelligence
      • CODEai
      • FOLFIRSTai
      • GPSai
    • Clinical Trial Solutions
      • Clinical Trials Connector
      • Right in Time
    • Biopharma
      • Discovery
      • Clinical Development
      • Commercialization
      • MI Trials
  • Research
    • Publications
    • R&D Tools
  • Precision Oncology Alliance
    • POA Members
    • POA Leadership
    • POA Working Groups
    • POA Publications
    • POA Newsletter
  • Resources
    • Video Library
    • EHR Integrations
    • Caris Molecular Tumor Board
    • Molecular Minute Podcast
    • Webinars
    • Caris+ App
    • Request Supplies
  • Careers
    • Career Opportunities
    • Benefits
    • Our People
  • About
    • Leadership
    • Newsroom
    • Locations
    • Events
    • Caris Foundation
    • Contact Us

Annual Notice to Physicians 2023

June 20, 2023

2023 Annual Notice to Physicians

Dear Physician/Client:

In accordance with the requirements of The Office of the Inspector General (OIG), this letter serves as the Caris Life Sciences® (Caris) annual notice to physicians and other qualified healthcare providers. The information below provides an overview of our policies and procedures and reflects our commitment to conducting business in accordance with federal, state and local laws, as well as adherence with program requirements for federal, state and private health plans. Additional details related to privacy policies, terms and conditions and other procedures can be found at www.CarisLifeSciences.com.

Clinical Consultant

Clinical operations and overall laboratory quality is led by Senior Vice President and Executive Medical Director, Matthew Oberley, MD, PhD. Caris medical staff, including Dr. Oberley, are available to assist with testing questions including ordering or result interpretation. Please contact Customer Support at 888-979-8669 or CustomerSupport@CarisLS.com to schedule a consultation.

Testing Options

Comprehensive tumor profiling from Caris assesses DNA, RNA and Proteins with multiple technologies to reveal a more complete molecular blueprint to guide precise and individualized treatment decisions that may improve patient outcomes.

  • MI Profile™ consists of MI Tumor Seek Hybrid™ + IHCs and Other Tests by Tumor Type. This tissue-based option for solid tumors includes whole exome sequencing (WES) and whole transcriptome sequencing (WTS) analysis, plus additional tumor type relevant biomarker testing (IHC, ISH, etc.). Caris FOLFIRSTai™ is reported for mCRC cases.
  • MI Tumor Seek Hybrid™ is a tissue-based option for solid tumors that only includes WES and WTS analysis. Caris FOLFIRSTai™ is reported for mCRC cases.
  • Caris FOLFIRSTai™ is an AI-powered molecular predictor of chemotherapy efficacy and treatment sequence for mCRC patients.
  • Caris GPSai™ is a predictive algorithm to identify cancers of unknown primary (CUP) or cases with atypical clinical presentation or clinical ambiguity.

In certain localities, specific Caris tests may not be approved1. If such a test is ordered in those regions, Caris may alter the order to a version that is approved (if available), which may include some features ordered by the provider. Alternatively, Caris may cancel the ordered test and the ordering provider will be notified.

Reflex Laboratory Testing

Reflex testing is additional testing that is automatically performed based on the initial results and is separately billed. Further information about Caris reflex testing can be found at www.CarisLifeSciences.com.

Caris Reporting

The Caris report outlines the molecular profile of the patient’s tumor and aligns it to a list of relevant therapeutic agents associated with potential benefit or potential lack of benefit. The report is designed to provide the key biomarker and therapeutic information in an easy-to-interpret front page, with details of all testing performed and references supporting the therapeutic association provided later in the report. After testing, the Caris report can be delivered via the practice’s EMR, fax, email (MI Portal credentials required), Caris+ App or MI Portal.

Medical Necessity

Medicare pays for services that are reasonable, necessary and meet specified coverage criteria for the beneficiary’s unique medical condition.

As a participating Medicare provider, Caris has the responsibility to make good faith efforts to ensure that all tests requested are performed and billed in a manner that is consistent with federal and state statutes and regulations. The OIG takes the position that ordering providers authorized by law to order clinical laboratory tests for Medicare beneficiaries share the burden of ensuring that only medically necessary services are ordered and billed to Federally funded programs. Providers who submit false claims may be subject to sanctions or remedies available under civil and administrative law.

The Caris Test Requisition Form (TRF) includes a comprehensive set of attestations to determine the coverage status for Medicare services. Completion of the “Relevant Clinical History” section of the TRF enables appropriate determination of coverage for rendered services.

Laboratory claims submitted for services will only be paid if the service is covered, reasonable, and necessary for the beneficiary, given his or her clinical condition, as defined by CMS.

Advance Beneficiary Notice (ABN)

Medicare will only pay for Part B Laboratory services that are determined to be reasonable and necessary. Caris may need to obtain an Advance Beneficiary Notice (ABN) and/or provide a Notice of Non-Coverage to a beneficiary/patient in advance of what is believed to be a non-covered laboratory service (as determined by the Centers for Medicare and Medicaid Services (CMS) guidelines and/or the fiscal intermediary, and/or other third-party payers).

Medicare Reimbursement Fee Schedule

Medicare reimburses laboratory services based upon a published fee schedule. Medicaid FFS programs typically reimburse based on a fee schedule and the reimbursement is typically equal to or less than the amount Medicare reimburses.

Medicare Coverage Determinations

Services rendered by Caris are typically documented in either Local Coverage Determinations (LCDs) or National Coverage Determinations (NCDs). LCDs and NCDs have sections describing what medical conditions are covered and the ICD-10 codes that are covered. All clinical orders sent to Caris must include at least one ICD-10 code and should include all appropriate ICD-10 codes which describe the patient’s unique medical condition.

Prohibited Referrals and Inducements

It is Caris’ policy to comply with both the Physician Self-Referral Law (Stark) and the Anti-Kickback Statute. If a financial relationship exists between a physician (or their immediate family member) and a laboratory, the Stark Law prohibits the physician from referring Medicare beneficiaries to the laboratory, and the laboratory cannot bill Medicare for any services referred by the physician unless the financial relationship between the parties falls into one of the law’s exceptions. The Anti-Kickback Statute prohibits the knowing or willful offer, payment, solicitation, or receipt of remuneration to induce business reimbursed under the Medicare or Medicaid programs. Any form of kickback or inducement to secure Medicare or Medicaid referrals is prohibited.

Patient Privacy

Under the Health Insurance Portability and Accountability Act (HIPAA), Caris is a healthcare provider and a covered entity. We are committed to compliance with all HIPAA privacy and security standards. A copy of our Notice of Privacy Practices is available at www.CarisLifeSciences.com/privacy-us.

Thank you for your time and attention. If you have any questions or require any further information, please contact me directly at 866-771-8946.

Thank you,     

Ginger Appleberry
SVP, Chief Compliance Officer and Deputy General Counsel
Caris Life Sciences

Annual Notice to Physicians 2023 PDF

 

  1. Caris FOLFIRSTai, Caris GPSai, HLA Genotype, etc.
Expertise
Menu
  • Molecular Profiling
  • Artificial Intelligence
  • Publications
  • Precision Oncology Alliance
  • Clinical Trial Solutions
  • Biopharma
  • Caris Molecular Tumor Board
  • Molecular Minute Podcast
Resources
Menu
  • Order
  • Pay Your Bill
  • Find a Physician
  • MI Portal
  • Request Supplies
  • Laboratory Accreditations & Licenses
  • Investigator Studies Program
  • International Distributors
connect
Menu
  • Contact Us
  • Careers
  • Leadership
  • Locations
  • Newsroom
  • Video Library
  • Events
follow us
Menu
  • Privacy & Website Policies
  • Terms & Conditions
  • Annual Notice to Physicians
© 2023 Caris Life Sciences. All rights reserved.
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept,” you consent to the use of all cookies.
Do not sell my personal information.
Cookie SettingsAccept
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT