Understanding reimbursement policies is critical for health care professionals, particularly when it comes to molecular syndromic panels for infectious disease pathogen identification testing. Learn more about Molecular Diagnostic (MoIDx) reimbursement criteria and practical approaches to meeting these requirements.
The following content is based on the webinar Molecular Multiplex Pathogen Panels: Clinical Utility and Reimbursement Challenges, sponsored by Applied BioCode in collaboration with GenomeWeb and Dr. Matthew D. Sims, M.D., Ph.D. (Director of Infectious Diseases Research at Corewell Health East) and Dr. Joseph D.C. Yao, M.D. (Director, Viral Hepatitis / HIV / COVID Testing Laboratory at Mayo Clinic and Mayo Clinic Laboratories).
How Does Medicare Reimbursement Work?
To navigate reimbursement criteria, it is crucial to first and foremost understand the Medicare reimbursement process. This involves the following key components:
- The Centers for Medicare and Medicaid Services (CMS): CMS is the federal agency responsible for administering Medicare reimbursements.
- Medicare Administrative Contractors (MACs): MACs are regional contractors that process Medicare Part A and Part B (A/B) medical claims or Durable Medical Equipment (DME) claims for Medicare Fee-For-Service (FFS) beneficiaries. They are responsible for acting as a liaison between the Medicare Fee for Service Program and health care providers in their region.
- Current Procedural Terminology (CPT®) codes: CPT® codes correlate with specific health care services and tests. Molecular diagnostic tests have dedicated codes that are used to establish Medicare reimbursement.
What Is the MoIDx Program?
Palmetto GBA established the Molecular Diagnostic (MoIDx) Program in 2011 to create a structured approach to reimbursement for molecular diagnostic tests. Currently, it outlines uniform policies for 28 states in the U.S. across four MACs.
MolDX Reimbursement Criteria for Molecular Syndromic Panels
In June 2022, reimbursement rules were issued regarding molecular syndromic panels (LDC L38988, A58710). The policy focuses solely on outpatient testing, introducing criteria that must be met for infectious disease pathogen identification testing reimbursement.
As defined in the policy, a syndromic panel is a test that simultaneously detects multiple pathogens associated with overlapping clinical features. The policy further divides panels into the following categories:
- Targeted Panels: Tests for five pathogens or fewer.
- Expanded Panels: Tests for six pathogens or more.
The policy does not outline coverage for the following tests:
- Metagenomic Next-Generation Sequencing (mNGS)
- Mass Spectrometry
- Fluorescence In Situ Hybridization (FISH)
Clinical Utility and Validation Requirements for Laboratory Developed Tests (LDTs)
For new Laboratory Developed Tests (LDTs) —or non-FDA-approved tests— that do not have designated CPT® codes, a laboratory may register for a DEX Z-Code and request a technical assessment with the Palmetto GBA.
To ensure that only clinically relevant tests receive reimbursement, all LDTs must demonstrate clinical utility and validation. This data needs to be submitted to the respective MAC for approval before reimbursement can be processed.
Specific Panel Requirements for Reimbursement
MolDX criteria provide reimbursement guidelines for various molecular syndromic panels, including:
1. Respiratory (RP) and Pneumonia (PNP) Panels
For immunocompetent patients, or those with known underlying respiratory pathology, a respiratory/pneumonia panel may be ordered by or in consultation with the following specialists:
- Infectious disease
- Pulmonary
For immunocompromised patients, a respiratory/pneumonia panel may be ordered by or in consultation with the following specialists:
- Infectious disease
- Pulmonology
- Oncology
- Transplant
CPT codes for respiratory and pneumonia panels include: CPT 87632, 87633, 87801
2. Gastrointestinal (GI) Panels
For immunocompetent patients, or those with known underlying respiratory pathology, a gastrointestinal (G) panel may be ordered by or in consultation with the following specialists:
- Infectious disease
- Gastrointestinal
For immunocompromised patients, a gastrointestinal (GI) panel may be ordered by or in consultation with the following specialists:
- Infectious disease
- Gastrointestinal
- Oncology
- Transplant
For all patients, any clinician may order a gastrointestinal (GI) panel in the case of diarrheal illness lasting over 7 days, given that the patient is not on laxatives within 24 hours of testing.
CPT codes for GI panels include: CPT 87506, 87507
3. Meningoencephalitis (ME) Panels
For all patients, any clinician may order a meningoencephalitis (ME) panel so long as the collection of cerebrospinal fluid (CSF) is from lumbar puncture only, not from indwelling medical devices.
CPT codes for ME panels include: CPT 87483
4. Bloodstream Infection (BSI) Panels
For all patients, bloodstream infection (BSI) panels are covered under specific criteria, including concern for clinical sepsis and the involvement of an antimicrobial stewardship team.
CPT codes for BSI panels include: CPT 87154
5. Urinary Tract Infection (UTI) Panels
For all patients, UTI panels are covered if patients are evaluated by the following specialists:
- Urology
- Gynecology
UTI panels are also covered if clinical features are present and the patient is at high risk for complications.
CPT codes for UTI panels include: CPT 87801
6. Infectious Vaginitis Testing
Coverage for infectious vaginitis testing requires detection of at least two of the following pathogens:
- Gardnerella vaginalis
- Other bacterial vaginosis (BV)-associated bacteria (BVAB)
- Trichomonas vaginalis
- Candida species
CPT codes for infectious vaginitis panels include: CPT 81513 (bacterial), 81514 (bacteria + Candida) , 87800 (direct probe), 87801 (amplified probe)
Approaches to Meet MolDX Reimbursement Criteria
With these reimbursement guidelines in mind, health care professionals must adapt their practices to meet MoIDx criteria effectively. The following strategic approaches may help streamline compliance:
1. Implement a Diagnostic Stewardship Program
A diagnostic stewardship program ensures that the appropriate diagnostic tests are ordered based on clinical presentation. From test ordering to the interpretation of results, diagnostic stewardship promotes timely and precise diagnosis and treatment, ultimately raising the quality of care. Research suggests that the use of molecular syndromic panels for infectious disease pathogen identification testing improves the quality of patient management and reduces unnecessary interventions.
A diagnostic stewardship program may include regular training sessions for medical professionals, increased collaboration between laboratory staff and providers to discuss test appropriateness, and ongoing stakeholder feedback.
2. Utilize Automated EHR Reminders
Integrating automated pop-up reminders within Electronic Health Records (EHR) systems can significantly enhance compliance with pre-requisite testing criteria.
These notifications remind medical professionals about consultation requirements or previous test results. This prevents the unnecessary duplication of tests and increases adherence to reimbursement requirements.
3. Optimize Your Lab Test Billing Software
A well-programmed billing software is important for avoiding claim denials. This addresses common issues such as sending CPT® codes of overlapping syndromic panels to insurance payers.
Ensure that your billing software is updated regularly to reflect any changes in guidelines. It is also advisable to create algorithms that flag potential overlaps before claims are submitted.
4. Invest In a System with Data Masking Capability
An instrument with data masking capability, such as the BioCode® MDx-3000, allows selective coverage of certain pathogen targets based on physician orders.
By not testing for pathogen targets a physician does not suspect, masking addresses several common reimbursement and liability challenges. Consider investing in a system with data masking capability to ensure insurance coverage for pathogen testing.
Integrate Molecular Syndromic Panel Testing Into Your Clinical Workflow
The MoIDx Program presents both challenges and opportunities for health care professionals. A strong understanding of these guidelines not only keeps you compliant but also optimizes therapeutic interventions through effective pathogen identification.
At Applied BioCode, we are at the forefront of innovation in molecular diagnostics. We specialize in high-throughput syndromic panel testing for infectious diseases, utilizing Barcoded Magnetic Bead (BMB) technology designed to maximize speed and accuracy for diagnostic laboratories. Contact us today to learn more about how our selection of syndromic panel products, including the BioCode® Respiratory Pathogen Panel (RPP) and Gastrointestinal Pathogen Panel.