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Coding Quality Update: Understanding Medicare’s Revisions to LCD L36351 for Pathology

Effective November 2, 2025, Medicare’s update to LCD L36351, which governs the use of special stains and immunohistochemistry (IHC) in pathology, represents a meaningful shift in how pathology labs document, justify, and code diagnostic testing. For health systems, this change heightens reimbursement risk if diagnostic detail and coding accuracy aren’t tightly aligned.

The update reinforces the need for medical necessity and precise documentation - central to maintaining compliance, reimbursement accuracy, and quality care. For pathology departments and medical coding teams, this is an opportunity to elevate documentation standards to align with CMS expectations and strengthen coding quality across the board. 

CodaMetrix is working with leading health systems to prepare for these changes - helping teams identify documentation gaps early, enhance coding accuracy, and ensure pathology reporting meets Medicare’s new requirements.

From Routine to Clinically Justified Testing

Many pathology departments rely on reflex panels or standing orders to streamline workflows. Under LCD L36351, stains must now be ordered with clear, case-specific rationale, and that reasoning must be documented within the pathology report. While most cases will require an H&E review before ordering special stains or IHC, LCD L36351 allows for limited exceptions when medically necessary based on established diagnostic protocols.

Labs that fail to include sufficient justification in reports could see more denials, while those that proactively strengthen documentation will better protect reimbursement and patient care. 

Lab Reports must clearly specify:

  • Which block(s) were tested
  • Why additional testing was performed
  • The specific markers used (single vs. cocktail)
  • How results informed diagnosis or treatment decisions

Disease-Specific Clarifications

LCD L36351 provides explicit expectations for several high-volume disease areas:

  • Breast Pathology: ER, PR, and HER2 testing remain covered for primary invasive breast cancers and for recurrent or metastatic disease. PR testing may be considered optional in some in-situ (DCIS) cases per ASCO/CAP guidelines. Ki-67 is covered only for select ER+/HER2 negative lymph node positive high-risk breast patients eligible for abemaciclib therapy.
  • GI Pathology: Routine stains (e.g., H. pylori, CDX-2, mucin stains) are not considered reasonable or necessary unless H&E findings justify them.
  • Prostate: IHC on morphologically negative cores is not covered unless documentation shows results directly influenced treatment.
  • Lung Cancer: A limited, focused stain set (e.g., TTF-1, p40, or p63) is typically sufficient.

These updates reinforce that test selection should reflect diagnostic findings and medical necessity, not routine ordering, thus ensuring each test is supported by clear documentation within the pathology report.

Navigating the Path Forward

LCD L36351 is a reminder that high-quality coding begins with high-quality documentation. When the clinical rationale is clear, coding accuracy and timely reimbursement follow.

At the same time, these expectations can add workload to already stretched teams. Partnering with technology that reduces manual coding tasks or flags potential documentation gaps can help pathologists and coding teams focus on what matters most: accurate interpretation and clinically meaningful reporting.

When documentation and medical coding operate in sync, compliance becomes a byproduct of quality, not an added burden.

As the LCD L36351 revisions take effect on November 2, 2025, proactive preparation will help health systems safeguard reimbursement and maintain compliance without sacrificing efficiency. Strengthening documentation and coding alignment today sets the foundation for more accurate, efficient, and patient-focused pathology practices. CodaMetrix customers are already taking steps in this direction, our teams are partnering closely with pathology and coding departments to identify documentation gaps early, enhance coding quality, and ensure readiness well ahead of these policy changes.

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