April 26, 2022
Annual Notice to Physicians 2022
The Office of the Inspector General (OIG) has issued guidance that recommends laboratories provide notices to physicians and other ordering providers annually as part of their compliance plan. Caris Life Sciences® (Caris) is issuing this notice in accordance with this recommendation. We are committed to conducting business in accordance with all federal, state and local laws, and in adherence with program requirements for all federal, state and private health plans. This letter serves as continuing education for ordering providers on our policies and procedures as they relate to these expectations.
Caris medical staff, including Medical Director Dr. Matthew Oberley, are available to assist with reference testing questions, including ordering and interpretation. Please contact Customer Support at 888-979-8669 or CustomerSupport@CarisLS.com to schedule a consultation.
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 and improve patient outcomes.
In certain localities, a given Caris test may not be approved1. If the test is ordered in those regions, Caris may change 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 Tests
Based on the submitted sample and after initial assessment, reflex testing may be automatically performed for limited tissue cases, and separately billed. Further information about Caris reflex testing can be found on the Caris website (www.CarisLifeSciences.com).
The Caris report aligns the molecular profile of the patient’s tumor 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.
Medicare pays for services that are reasonable and necessary and meet specified Medicare 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. We 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 Life Sciences 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 the policy of Caris 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 in order to induce business reimbursed under the Medicare or Medicaid programs. Any form of kickback or inducement to secure Medicare or Medicaid referrals is strictly prohibited.
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 to these important concepts. If you have any questions or require any further information, please contact me directly at 866-771-8946.
SVP, Chief Compliance Officer and Deputy General Counsel
Caris Life Sciences
1. Caris FOLFIRSTai, Caris GPSai, HLA Genotype, etc.