Sunrise Medical Laboratories (SML) is providing this notice as part of our compliance program in accordance with OIG recommendations to clinical laboratories.
Periodically, SML advises its physicians and clients about program changes and information related to federally‐funded healthcare programs that affect both the provider and laboratory. Please note that these notices are intended to help both the provider/client and the laboratory comply with these regulations and mitigate the risks for all parties.
When ordering tests for which Medicare reimbursement will be sought, the following regulations apply:
Licensed Physicians and Non‐Physician Practitioners (NPP)
A clinical laboratory may only bill Medicare and Medicaid for testing ordered by a licensed provider authorized by law to order laboratory tests. If your license has been revoked or suspended, please immediately notify the laboratory. 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). This enrollment is required of all providers, including physicians and non-physician practitioners (NPP), even if they themselves do not offer services to Medicare beneficiaries Additional information on PECOS and how to enroll in the system may be viewed at https://pecos.cms.hhs.gov/providers/index.html
Medical Necessity
Tests that are medically necessary for the diagnosis or treatment of a Medicare patient are covered and may be reimbursed by Medicare. An approved test panel must only be ordered when every test in that panel is medically necessary. If all components of the panel are not medically necessary, you should order individual tests or a panel that contains only the medically necessary tests. Screening or Investigational Use Only tests are generally not covered by Medicare, with some exceptions for Wellness Screens. As a Medicare participating provider, SML has a responsibility to make good faith efforts to ensure that all tests requested are performed and billed in a manner consistent with all federal and state laws and regulations. The OIG takes the position that providers authorized by law to order laboratory tests, who knowingly cause a false claim to be submitted to any federally funded program, may be subject to sanctions or remedies available under civil, criminal and administrative law, such as the False Claims Act.
American Medical Association (AMA) Organ or Disease‐Oriented Panels
Authorized ordering providers should only order AMA defined Organ or Disease‐Oriented Panels when all components are medically necessary. The AMA panels were developed for coding purposes only and should not be interpreted as clinical parameters.
Note: The AMA panels and their components are listed in an attachment to this notice.
Custom Profiles
A custom profile is a specific group of commonly ordered tests, or panels which have not been defined by the AMA or CMS, which are medically necessary in treating a condition. Custom panels are established as defined by the requesting Healthcare Provider (HCP) and may be used only by that HCP. An SML Laboratory Director will be responsible for validating custom profiles by reviewing a signed Physician Acknowledgement annually from each client for each custom profile utilized in the treatment of his/her patients.
The OIG has noted that such profiles present the danger that, by defaulting to such a profile, the physician may in a particular case be ordering one or more medically unnecessary tests contained in the profile. The OIG takes the position that ordering unnecessary tests within a profile, even when done without a specific intent to defraud, may subject the ordering physician to civil penalties.
If modification to custom profile is warranted, the requesting physician is advised to contact his/her Client Support Coordinator (CSC) to assist with adding, updating or deleting.
Diagnosis Information
Section 4317 of the Balanced Budget Act of 1997 requires the authorized ordering provider to submit diagnosis information on the laboratory order for submission of a Medicare insurance claim. The diagnosis information supplied should accurately describe the patient’s condition on the date of service as documented in the patient’s medical record. If you are ordering a test and cannot yet determine a diagnosis, you must provide the appropriate ICD-10 code that describes the patient’s signs and symptoms. Laboratories are prohibited from using diagnostic information provided by the physician from earlier dates of service (except for certain standing orders, as described below), and from inserting diagnosis codes based on their own evaluation of the patient’s probable or most likely diagnosis, or from speaking with a patient.
Providers’ offices will be contacted by SML in the event that this required information is omitted on any laboratory order, and this communication may occur via telephone call or fax. Additions, Revisions, and Deletions for ICD‐10‐CM codes which became effective on October 1, 2023 may be viewed at: https://www.cms.gov/medicare/coding-billing/icd-10-codes/2018-icd-10-cm-gem
2023 Medicare Clinical Diagnostic Laboratory Tests Payment System
Effective January 1, 2018, the Clinical Laboratory Fee Schedule (CLFS) reimbursement rates were revised to be based on the weighted median private payor rates as required by the Protecting Access to Medicare Act (PAMA) of 2014. Co‐payments and deductibles do not apply to services paid under the Medicare clinical laboratory fee schedule. Also, Medicaid reimbursement will be equal to, or lesser than Medicare reimbursement.
The 2023 Medicare Clinical Laboratory Fee schedule may be viewed and downloaded at: https://www.cms.gov/medicaremedicare-fee-service-paymentclinicallabfeeschedclinical-laboratory-fee-schedule-files/22clabq4 for the fee schedule listing.
Medicare Laboratory Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs)
Coverage determination policies define the medical conditions through the inclusion of a list of ICD‐10 (diagnosis) codes for which tests are covered or reimbursed by Medicare. HIPAA regulations require ICD‐10 code(s) to be present on each claim filed. These codes must also be documented in the patient’s medical record. Property and casualty, auto and workers' compensation insurance are not covered entities and are therefore not required to comply with HIPAA. All laboratory NCDs may be viewed at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/LabNCDsICD10
To search the Medicare coverage database: https://www.cms.gov/medicare-coverage-database/new-search/search.aspx. The Centers for Medicare and Medicaid Services has authorized NGS Medicare, as a jurisdiction Medicare Part B carrier, to develop Local Coverage Determinations (LCD). These guidelines may supplement or be in addition to the National Coverage Determinations and give direction for medical necessity on selected tests. The LCDs may be viewed at: https://www.ngsmedicare.com/medical-policies?lob=96664&state=97133&rgion=93623
Advance Beneficiary Notice of Non-coverage (ABN)
Not all laboratory services are covered by Medicare. For statutorily excluded services, SML may bill Medicare patients directly. For certain other laboratory tests, an Advance Beneficiary Notice of Non-coverage (ABN) is used to document that the patient has been made aware that Medicare may not pay for service(s) and has agreed to pay the laboratory in the event payment is denied by Medicare. A separate ABN must be used/completed for each specimen collection encounter. SML will provide ABN forms to clients at their request. Client‐collected ABNs must accompany the order/requisition when samples are submitted to the laboratory.
SML be responsible for collecting the ABN from the patient when there is a face‐to‐face interaction between the patient and a laboratory staff member. Please check the expiration date located in the lower left hand corner of the ABN, to assure the most current form (Exp. 01/31/2026) is being utilized and completed, when an ABN is needed for a Medicare beneficiary. Information about ABNs may be viewed at: https://www.cms.gov/Medicare/Medicare-General-Information/BNI/ABN
Billing Information
SML requires the following information to enable our Billing Department to bill Medicare, Medicaid or other commercial insurance. The SML requisition contains adequate, clearly labeled spaces to provide this information:
- Date of Order
- Patient’s full name,
- Patient’s current complete address, city, state and zip code,
- Date of birth and gender,
- Patient’s insurance company name, ID number including prefix/suffix, if applicable.
- Ordering/referring Provider’s name and NPI number,
- Valid ICD‐10‐CM diagnosis code(s) for each test, not just Medicare Limited Coverage Tests, and
- A valid ABN, when mandated by Medicare NCD/LCD policy.
Provider Signatures
The revised Medicare Learning Network Fact Sheet (MLN) now requires the ordering provider’s handwritten or electronic signature to show proof of an authenticated medical record supporting the provider’s intent to order specific tests. In order to comply with this requirement, SML will contact the provider to retrieve such authentication prior to providing laboratory services to patients. This information may be viewed at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ProviderComplianceLabServices-Fact-Sheet-ICN909221.pdf
Reflex Testing
Reflex testing occurs when initial test results are positive or outside normal parameters and indicate that a second related test is medically appropriate for patient care because some results trigger multiple tests (cascade testing). Please see the laboratory test directory for tests that may require reflex testing. Whenever you order an initial test subject to a reflex test, you must consider whether the reflex test is, in your judgment, medically necessary for that particular patient. If you consider the reflex test unnecessary, order the initial test without the reflex test on the requisition form.
Preventive/Screening Services
Statutorily, Medicare does NOT cover any lab testing for routine and/or screening purposes. However, Medicare does cover some Preventive lab tests (PSA, Glucose, Lipids, etc.) if ordered as required by Medicare. For Preventive benefit information including test names, CPT codes, required ICD-10 codes and frequency limitations, please reference: https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo
Medicare Part B National Correct Coding Initiative (NCCI) Edits
The Medicare NCCI was implemented to promote national correct coding methodologies and to control improper coding leading to inappropriate payment. Information on the NCCI edits may be found at: https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html
Prohibited Referrals and Inducements
It is the policy of SML 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.
Client Services
Client Services representatives are available at telephone number (800)-782-0282 Option 5 for clients. Please take a few minutes to review this information with your staff. We value your business and appreciate the opportunity to serve your laboratory needs in conjunction with these initiatives. If there are further questions regarding this information, please contact your Account Executive or Client Service Coordinator.
Reporting
Should you observe or suspect any violations as mentioned under Prohibited Referrals and Inducement section of this notification, please alert Sunrise Medical Laboratories Compliance Department:
Compliance Department
250 Miller Place
Hicksville, NY 11801
Phone: 800.782.0282 x1658
Email: Compliance@sunriselab.com
Laboratory/Clinical Questions
Laboratory Director
Milind Mondkar, MD
Phone: 800-782-0282 ext.1146
Email: mmondkar@sunriselab.com
2023 AMA Recognized Organ and Disease‐Oriented Panels