Date: 05/19/2023

To: Bernhardt Laboratories Client

From: Compliance Department

Re: 2023 Annual Notice to Physicians

Bernhardt Laboratories is providing annual notification to our clients of the Medicare policies governing the ordering and reimbursement of laboratory tests. Bernhardt Laboratories is committed to promoting awareness of and adherence to these policies. In accordance with the Office of the Inspector General’s (OIG) Compliance Program Guide for Clinical Laboratories, we are providing the following information about Medicare requirements:

CMS Medical Necessity Policy

Medicare will only pay for tests that meet the Medicare definition of “medical necessity”. Medicare may deny payment for a test that the physician believes is appropriate, such as a screening test, which does not meet the Medicare definition of medical necessity. All diagnosis and clinical relevance for patient treatment should be noted in the patient’s chart.

The OIG takes the position that an individual who knowingly causes a false claim to be submitted may be subject to sanctions or remedies available under civil, criminal and administrative law.

Individuals who knowingly cause a false claim to be submitted to Medicare may be subject to sanctions or remedies available under civil, criminal and administrative law.

CMS Signature Requirements

According to CMS’ guidance on laboratory services documentation requirements, unsigned requisitions alone do not support physician intent to order. Physicians should sign all orders for diagnostic services to avoid potential denials. https://www.cms.gov/Outreach-and- Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/LabServices- ICN909221- Text-Only.pdf

Medicare Laboratory National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs)

Coverage determination policies define medical conditions through the inclusion on a list of ICD (diagnosis) codes for which these tests are covered or reimbursed by Medicare. HIPAA regulations require ICD codes to be present on each claim filed. These codes must also be documented in the patient’s medical record.

NCDs: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/LabNCDsICD10.html

LCDs: https://www.fcso.com/

First Coast Services Options Medicare Jurisdiction N

Frequency Limitations for Laboratory Tests

Certain laboratory tests have specific frequency limitation requirements. The limitations may apply to tests that are included in NCDs and LCDs.

Medicare Preventive Screening Laboratory Tests

Certain preventive screening laboratory tests are covered services for Medicare beneficiaries. Benefit coverage is specific for each service, diagnosis codes, coverage requirements, and frequency limitations. https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html

American Medical Association (AMA) Organ or Disease-Oriented Panels

The AMA panels were developed for coding purposes only and should not be interpreted as clinical parameters. Organ and disease-oriented panels will only be paid by Medicare when all tests within the panel are deemed medically necessary by Medicare.

Section 90.2 – Organ or Disease Oriented Panels

In the case of custom test panels, all individual tests must meet medical necessity guidelines.

Reflex Testing

Reflex testing occurs when initial test results indicate that a second related test is medically appropriate or required by state, regulatory, or accreditation standards. Most tests can be ordered without a reflex. Find details at https://www.sonichealthcareusa.com/ap/testing-solutions/test-menu/

Advance Beneficiary Notice of Non-Coverage (ABN)

• Limited Coverage -- An ABN is required if the diagnosis is not covered
• Frequency Limit -- An ABN is required at each encounter for frequency limited tests
• Non-Coverage -- An ABN is required for experimental or research use tests or tests designated by Medicare as non-covered

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals- IOMs.html

Manual 100-04 Medicare Claims Processing Manual

Chapter 30 Financial Liability Protections

Section 50 Form CMS-R-131 Advance Beneficiary Notice of Non-Coverage (ABN)

Medicare Clinical Laboratory Fee Schedule (CLFS)

Medicare reimbursement for laboratory CPT/HCPCS codes is located at. https://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files

Additional details can be found at PAMA regulations.

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations

Medicaid reimbursement amount will be equal to, or less than, the amount of Medicare reimbursement.

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.

Contact Information

The Medical Directors and other pathologists are available to discuss appropriate testing and test ordering. Please call 904.296.2333 for assistance. You may also contact our Compliance Department at . APCompliance@sonichealthcareusa.com

Please review this notice with all appropriate staff.

Thank you for supporting Bernhardt Laboratories.

Printable Version

On November 30, 2021, the U.S. SARS-CoV-2 Interagency Group (SIG), which includes the Centers for Disease Control and Prevention (CDC), the National Institutes of Health, the Food and Drug Administration (FDA), and Health and Human Services (HHS), classified the Omicron variant as a Variant of Concern. The current understanding of the Omicron VOC at this time is as follows: 

• Preliminary data from South Africa suggest that the mutations to the receptor binding protein of the variant virus will confer increased infectivity.
• Preliminary studies indicate that there are no unusual symptoms associated with Omicron variant infection, and as with other variants, some patients are asymptomatic. Symptoms may be milder in persons who have been vaccinated or previously infected with SARS CoV-2.
• The presence of mutations in the SARS-CoV-2 virus in a patient sample has the potential to impact test performance. The impact of mutations on a test's performance is influenced by several factors, including the sequence of the variant, prevalence of the variant in the population, and the design of the test including the analytic target. Indeed, tests which interrogate for a single target are particularly vulnerable.

Laboratory evaluation of SARS-CoV-2, including the Omicron Variant of Concern, at Bernhardt Laboratories: 

• All high-throughput SARS-CoV-2 molecular assays performed at Bernhardt Laboratories are designed to interrogate for multiple targets of the viral genome and have received emergency-use authorization by the FDA.
• Based on in silico analysis, all molecular assays are expected to detect the Omicron variant of concern.
• For some assays, including the Thermo Fisher Taq Path PCR assay, a specific deletion in the spike (S) gene (Δ69-70) in the Omicron variant results in an S-gene dropout, also referred to as an S-gene target failure (SGTF).
  • The S-gene target failure pattern may be identified in the Omicron variant (BA.1 sub-lineage), but this pattern is also seen in previously identified variants (e.g., Alpha).
  • Since these tests are designed to detect multiple genetic targets, the overall test sensitivity is not significantly impacted.
  • The S-gene target failure pattern provides a signal that the Omicron variant (BA.1) may be present and that the isolate may be suitable for sequencing and/ or other public health considerations.
  • The S-gene target failure pattern does not necessarily mean that an individual with SARS-CoV-2 has the Omicron variant.
• For clients who have concerns about antigen or other point of care assays that they provide, the assay manufacturer can be contacted for information about expected analytical performance impact.

References: 

• New SARS-CoV-2 Variant of Concern Identified: Omicron (B.1.1.529) Variant. Health Alert Network 00459. December 1, 2021.
• SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. U.S. Food and Drug Administration. December 6, 2021.
• Technical Brief: Predicted Impact of Variants on Abbott SARS-CoV-2/COVID-19 Diagnostic Tests. Abbott. November 26, 2021
• Impact of SARS-CoV-2 mutations (including Omicron) on the cobas® SARS-CoV-2 and cobas® SARS-CoV-2 & Influenza A/B Tests for use on the cobas® 6800/8800 Systems and the cobas® SARS-CoV-2 and cobas® SARS-CoV-2 & Influenza A/B Tests for use on the cobas® Liat® System. Roche Client Bulletin. November 30, 2021.
• Thermo Fisher Scientific Confirms Detection of SARS-CoV-2 in Samples Containing the Omicron Variant with its TaqPath COVID-19 Tests. Thermo Fisher Client Bulletin. November 29, 2021.